Validated surrogate endpoints needed for peri-implantitis.

PubMed

Lee, Dong Won

2011-01-01

Pubmed, Cochrane and Lilac databases, Google, Google Scholar, hand searching of websites of major dental journals. The reference list of five recently published systematic reviews on peri-implantitis treatment were also screened for potential studies. Randomised controlled trials and non-randomised studies in English, German, French, Spanish and Italian on peri-implantitis treatment in humans were included. Case series, case reports and cross sectional or non-therapy studies were excluded from the assessment of endpoints. No minimum follow up time was set for studies that were included. Data were extracted in duplicate by two reviewers and disagreements were resolved by consensus. True endpoints for peri-implantitis treatment were considered only if they provided evidence of tangible benefit to the patient. The outcome variables regarded as true endpoints were implant failure, aesthetic assessment and variables related to quality of life, but these were only considered if they were clearly identified as an objective of the research, not as an outcome of treatment. Surrogate endpoints were considered as those measurements of clinical outcomes such as probing pocket depth and clinical attachment level. Fourteen studies were included in this review with data on implant failure presented solely as consequence of peri-implantitis therapy. No true endpoint was described for any study on peri-implantitis. Mean pocket probing depth, clinical attachment level and bleeding on probing were the three surrogate endpoints cited most often in the literature. All endpoints used in the trials reviewed are surrogates of clinical events, such as implant failure. Clinical surrogate endpoints should be validated to assess the real effect of these measures on true endpoints.

A computational method for comparing the behavior and possible failure of prosthetic implants

DOE Office of Scientific and Technical Information (OSTI.GOV)

Nielsen, C.; Hollerbach, K.; Perfect, S.

1995-05-01

Prosthetic joint implants currently in use exhibit high Realistic computer modeling of prosthetic implants provides an opportunity for orthopedic biomechanics researchers and physicians to understand possible in vivo failure modes, without having to resort to lengthy and costly clinical trials. The research presented here is part of a larger effort to develop realistic models of implanted joint prostheses. The example used here is the thumb carpo-metacarpal (cmc) joint. The work, however, can be applied to any other human joints for which prosthetic implants have been designed. Preliminary results of prosthetic joint loading, without surrounding human tissue (i.e., simulating conditions undermore » which the prosthetic joint has not yet been implanted into the human joint), are presented, based on a three-dimensional, nonlinear finite element analysis of three different joint implant designs.« less

Assessment of Safety and Effectiveness of the Extracorporeal Continuous-Flow Ventricular Assist Device (BR16010) Use as a Bridge-to-Decision Therapy for Severe Heart Failure or Refractory Cardiogenic Shock: Study Protocol for Single-Arm Non-randomized, Uncontrolled, and Investigator-Initiated Clinical Trial.

PubMed

Fukushima, Norihide; Tatsumi, Eisuke; Seguchi, Osamu; Takewa, Yoshiaki; Hamasaki, Toshimitsu; Onda, Kaori; Yamamoto, Haruko; Hayashi, Teruyuki; Fujita, Tomoyuki; Kobayashi, Junjiro

2018-06-08

The management of heart failure patients presenting in a moribund state remains challenging, despite significant advances in the field of ventricular assist systems. Bridge to decision involves using temporary devices to stabilize the hemodynamic state of such patients while further assessment is performed and a decision can be made regarding patient management. The purpose of this study (NCVC-BTD_01, National Cerebral and Cardiovascular Center-Bridge to Dicision_01) is to assess the safety and effectiveness of the newly developed extracorporeal continuous-flow ventricular assist system employing a disposable centrifugal pump with a hydrodynamically levitated bearing (BR16010) use as a bridge-to-decision therapy for patients with severe heart failure or refractory cardiogenic shock. NCVC-BTD_01 is a single-center, single-arm, open-label, exploratory, medical device, investigator-initiated clinical study. It is conducted at the National Cerebral and Cardiovascular Center in Japan. A total of nine patients will be enrolled in the study. The study was planned using Simon's minimax two-stage phase design. The primary endpoint is a composite of survival free of device-related serious adverse events and complications during device support. For left ventricular assistance, withdrawal of a trial device due to cardiac function recovery or exchange to other ventricular assist devices (VADs) for the purpose of bridge to transplantation (BTT) during 30 days after implantation will be considered study successes. For right ventricular assistance, withdrawal of tal device due to right ventricular function recovery within 30 days after implantation will be considered a study success. Secondary objectives include changes in brain natriuretic peptide levels (7 days after implantation of a trial device and the day of withdrawal of a trial device), period of mechanical ventricular support, changes in left ventricular ejection fraction (7 days after implantation of a trial device and the day of withdrawal of a trial device), and changes in left ventricular diastolic dimension (7 days after implantation of a trial device and the day of withdrawal of a trial device). We will disseminate the findings through regional, national, and international conferences and through peer-reviewed journals. UMIN Clinical Trials Registry (UMIN-CTR; R000033243) registered on 8 September 2017.

Disease management: remote monitoring in heart failure patients with implantable defibrillators, resynchronization devices, and haemodynamic monitors.

PubMed

Abraham, William T

2013-06-01

Heart failure represents a major public health concern, associated with high rates of morbidity and mortality. A particular focus of contemporary heart failure management is reduction of hospital admission and readmission rates. While optimal medical therapy favourably impacts the natural history of the disease, devices such as cardiac resynchronization therapy devices and implantable cardioverter defibrillators have added incremental value in improving heart failure outcomes. These devices also enable remote patient monitoring via device-based diagnostics. Device-based measurement of physiological parameters, such as intrathoracic impedance and heart rate variability, provide a means to assess risk of worsening heart failure and the possibility of future hospitalization. Beyond this capability, implantable haemodynamic monitors have the potential to direct day-to-day management of heart failure patients to significantly reduce hospitalization rates. The use of a pulmonary artery pressure measurement system has been shown to significantly reduce the risk of heart failure hospitalization in a large randomized controlled study, the CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients (CHAMPION) trial. Observations from a pilot study also support the potential use of a left atrial pressure monitoring system and physician-directed patient self-management paradigm; these observations are under further investigation in the ongoing LAPTOP-HF trial. All these devices depend upon high-intensity remote monitoring for successful detection of parameter deviations and for directing and following therapy.

Class III antiarrhythmic agents in cardiac failure: lessons from clinical trials with a focus on the Grupo de Estudio de la Sobrevida en la Insuficiencia Cardiaca en Argentina (GESICA).

PubMed

Doval, H C

1999-11-04

The results of previous clinical trials, in a variety of clinical settings, showed that class I agents may consistently increase mortality in sharp contrast to the effects of beta blockers. Attention has therefore shifted to class III compounds for potential beneficial effects on long-term mortality among patients with underlying cardiac disease. Clinical trials with d-sotalol, the dextro isomer (devoid of beta blockade) of sotalol, showed increased mortality in patients with low ejection fraction after myocardial infarction and in those with heart failure; whereas in the case of dofetilide, the impact on mortality was neutral. Because of the complex effects of its actions as an alpha-adrenergic blocker and a class III agent, the impact on mortality of amiodarone in patients with heart failure is of particular interest. A meta-analysis of 13 clinical trials revealed significant reductions in all-cause and cardiac mortality among patients with heart failure or previous myocardial infarction. Among these were 5 controlled clinical trials that investigated the effects of amiodarone on mortality among patients with heart failure. None of these trials was large relative to the beta-blocker trials in the postinfarction patients. However, the larger 2 of the 5 amiodarone trials produced discordant effects on mortality, neutral in one and significantly positive in the other. Some of the differences may be accounted for by the differences in eligibility criteria and baseline characteristics. Future trials that may be undertaken to resolve the discrepancies may need to allow for the newer findings on the effects of concomitant beta blockers, implantable devices, and possibly, spironolactone. All these modalities of treatment have been shown in controlled clinical trials to augment survival in patients with impaired ventricular function or manifest heart failure. Additional trials, some of which are currently in progress, compare amiodarone with implantable devices and other therapeutic interventions, and should help to clarify the optimal management strategy for patients with underlying heart failure.

Autogenous bone versus deproteinised bovine bone matrix in 1-stage lateral sinus floor elevation in the severely atrophied maxilla: a randomised controlled trial.

PubMed

Merli, Mauro; Moscatelli, Marco; Mariotti, Giorgia; Rotundo, Roberto; Nieri, Michele

2013-01-01

To compare 100% deproteinised bovine bone matrix (DBBM) grafts (test group) with 100% autogenous bone (AB) grafts (control group) for lateral maxillary sinus floor elevation in a parallel group, superiority, randomised controlled trial. Patients with 1 to 3 mm of residual bone height below the maxillary sinus were randomised for sinus floor elevation with DBBM and AB grafts and simultaneous implant placement. Randomisation was computer generated with allocation concealment by sealed envelopes and the radiographic examiner was blinded to group assignment. The abutment connection was performed 8 months after surgery and insertion of the provisional prostheses was performed 9 months after surgery. Outcome variables were implant failures, prosthetic failures, complications, chair time, postoperative pain and radiographic bone level 6 months after loading. Forty patients were randomised: 20 (32 implants) to the DBBM group and 20 (27 implants) to the AB group. One patient from the AB group dropped out. Two implant failures occurred in the DBBM group and no implant failure occurred in the AB group (P = 0.4872). All of the planned prostheses could be delivered. One complication occurred in the DBBM group and 2 in the AB group (P = 0.6050). Chair time was shorter for the DBBM group, with a difference of 27.3 minutes (P = 0.0428). Pain difference measured with a visual analogue scale for 6 days post-surgery was 0.2 in favour of the DBBM group (P = 0.6838). The difference in vertical bone height was 0.0 mm (95% CI -1.1, 1.1; P = 0.9703) and the difference in marginal bone level was 0.3 in favour of AB (95% CI -0.3, 0.9; P = 0.3220). No differences apart from chair time were observed when comparing DBBM and AB grafts with simultaneous implant placement in sinus elevation.

Stability of tapered and parallel-walled dental implants: A systematic review and meta-analysis.

PubMed

Atieh, Momen A; Alsabeeha, Nabeel; Duncan, Warwick J

2018-05-15

Clinical trials have suggested that dental implants with a tapered configuration have improved stability at placement, allowing immediate placement and/or loading. The aim of this systematic review and meta-analysis was to evaluate the implant stability of tapered dental implants compared to standard parallel-walled dental implants. Applying the guidelines of Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement, randomized controlled trials (RCTs) were searched for in electronic databases and complemented by hand searching. The risk of bias was assessed using the Cochrane Collaboration's Risk of Bias tool and data were analyzed using statistical software. A total of 1199 studies were identified, of which, five trials were included with 336 dental implants in 303 participants. Overall meta-analysis showed that tapered dental implants had higher implant stability values than parallel-walled dental implants at insertion and 8 weeks but the difference was not statistically significant. Tapered dental implants had significantly less marginal bone loss compared to parallel-walled dental implants. No significant differences in implant failure rate were found between tapered and parallel-walled dental implants. There is limited evidence to demonstrate the effectiveness of tapered dental implants in achieving greater implant stability compared to parallel-walled dental implants. Superior short-term results in maintaining peri-implant marginal bone with tapered dental implants are possible. Further properly designed RCTs are required to endorse the supposed advantages of tapered dental implants in immediate loading protocol and other complex clinical scenarios. © 2018 Wiley Periodicals, Inc.

Short dental implants versus standard dental implants placed in the posterior jaws: A systematic review and meta-analysis.

PubMed

Lemos, Cleidiel Aparecido Araujo; Ferro-Alves, Marcio Luiz; Okamoto, Roberta; Mendonça, Marcos Rogério; Pellizzer, Eduardo Piza

2016-04-01

The purpose of the present systematic review and meta-analysis was to compare short implants (equal or less than 8mm) versus standard implants (larger than 8mm) placed in posterior regions of maxilla and mandible, evaluating survival rates of implants, marginal bone loss, complications and prosthesis failures. This review has been registered at PROSPERO under the number CRD42015016588. Main search terms were used in combination: dental implant, short implant, short dental implants, short dental implants posterior, short dental implants maxilla, and short dental implants mandible. An electronic search for data published up until September/2015 was undertaken using the PubMed/Medline, Embase and The Cochrane Library databases. Eligibility criteria included clinical human studies, randomized controlled trials and/or prospective studies, which evaluated short implants in comparison to standard implants in the same study. The search identified 1460 references, after inclusion criteria 13 studies were assessed for eligibility. A total of 1269 patients, who had received a total of 2631 dental implants. The results showed that there was no significant difference of implants survival (P=.24; RR:1.35; CI: 0.82-2.22), marginal bone loss (P=.06; MD: -0.20; CI: -0.41 to 0.00), complications (P=.08; RR:0.54; CI: 0.27-1.09) and prosthesis failures (P=.92; RR:0.96; CI: 0.44-2.09). Short implants are considered a predictable treatment for posterior jaws. However, short implants with length less than 8 mm (4-7 mm) should be used with caution because they present greater risks to failures compared to standard implants. Short implants are frequently placed in the posterior area in order to avoid complementary surgical procedures. However, clinicians need to be aware that short implants with length less than 8mm present greater risk of failures. Copyright © 2016. Published by Elsevier Ltd.

Dental implants inserted in fresh extraction sockets versus healed sites: a systematic review and meta-analysis.

PubMed

Chrcanovic, Bruno Ramos; Albrektsson, Tomas; Wennerberg, Ann

2015-01-01

To test the null hypothesis of no difference in the implant failure rates, postoperative infection and marginal bone loss for the insertion of dental implants in fresh extraction sockets compared to the insertion in healed sites, against the alternative hypothesis of a difference. Main search terms used in combination: dental implant, oral implant, resh extraction socket, immediate placement, immediate insertion, immediate implant. An electronic search was undertaken in July/2014, in PubMed, Web of Science, Cochrane Oral Health Group Trials Register plus hand-searching. Eligibility criteria included clinical human studies, either randomized or not. The search strategy resulted in 73 publications, with 8,241 implants inserted in sockets (330 failures, 4.00%), and 19,410 in healed sites (599 failures, 3.09%). It is suggested that the insertion of implants in fresh extraction sockets affects the failure rates (RR 1.58, 95% CI 1.27-1.95, P<0.0001). The difference was not statistically significant when studies evaluating implants inserted in maxillae or in mandibles were pooled, or when the studies using implants to rehabilitate patients with full-arch prostheses were pooled; however, it was significant for the studies that rehabilitated patients with implant-supported single crowns and for the controlled studies. There was no apparent significant effect on the occurrence of postoperative infection or on the magnitude of marginal bone loss. The results should be interpreted with caution due to the potential for biases and to the presence of uncontrolled confounding factors in the included studies, most of them not randomized. The question whether immediate implants are more at risk for failure than implants placed in mature bone has received increasing attention in the last years. As the philosophies of treatment alter over time, a periodic review of the different concepts is necessary to refine techniques and eliminate unnecessary procedures. This would form a basis for optimum treatment. Copyright © 2014 Elsevier Ltd. All rights reserved.

The role of G-CSF in recurrent implantation failure: A randomized double blind placebo control trial.

PubMed

Davari-Tanha, Fatemeh; Shahrokh Tehraninejad, Ensieh; Ghazi, Mohadese; Shahraki, Zahra

2016-12-01

Recurrent implantation failure (RIF) is the absence of implantation after three consecutive In Vitro Fertilization (IVF) cycles with transferring at least four good quality embryos in a minimum of three fresh or frozen cycles in a woman under 40 years. The definition and management of RIF is under constant scrutiny. To investigate the effects of Granulocyte colony stimulating factor (G-CSF) on RIF, pregnancy rate, abortion rate and implantation rates. A double blind placebo controlled randomized trial was conducted at two tertiary university based hospitals. One hundred patients with the history of RIF from December 2011 until January 2014 were recruited in the study. G-CSF 300µg/1ml was administered at the day of oocyte puncture or day of progesterone administration of FET cycle. Forty patients were recruited at G-CSF group, 40 in saline and 20 in placebo group. The mean age for whole study group was 35.3±4.2 yrs (G-CSF 35.5±4.32, saline 35.3±3.98, placebo 35.4±4.01, respectively). Seventeen patients had a positive pregnancy test after embryo transfer [10 (25%) in G-CSF; 5 (12.5%) in saline; and 2 (10%) in placebo group]. The mean of abortion rates was 17.6% (3), two of them in G-CSF, one in saline group. The implantation rate was 12.3% in G-CSF, 6.1% in saline and 4.7% in placebo group. G-CSF may increase chemical pregnancy and implantation rate in patients with recurrent implantation failure but clinical pregnancy rate and abortion rate was unaffected.

Defibrillator implantations for primary prevention in the United States: Inappropriate care or inadequate documentation: Insights from the National Cardiovascular Data ICD Registry.

PubMed

Kaiser, Daniel W; Tsai, Vivian; Heidenreich, Paul A; Goldstein, Mary K; Wang, Yongfei; Curtis, Jeptha; Turakhia, Mintu P

2015-10-01

Prior studies have reported that more than 20% of implantable cardioverter-defibrillator (ICD) implantations in the United States do not adhere to trial-based criteria. We sought to investigate the patient characteristics associated with not meeting the inclusion criteria of the clinical trials that have demonstrated the efficacy of primary prevention ICDs. Using data from the National Cardiovascular Data Registry's ICD Registry, we identified patients who received ICDs for primary prevention from January 2006 to December 2008. We determined whether patients met the inclusion criteria of at least 1 of the 4 ICD primary prevention trials: Multicenter Automatic Defibrillator Implantation Trial (MADIT), MADIT-II, Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), and the Multicenter Unsustained Tachycardia Trial (MUSTT). Among 150,264 patients, 86% met criteria for an ICD implantation based on trial data. The proportion of patients who did not meet trial-based criteria increased as age decreased. In multivariate analysis, the significant predictors for not meeting trial criteria included prior cardiac transplantation (odds ratio [OR] 2.1), pediatric electrophysiology operator (OR 2.0), and high-grade atrioventricular conduction disease (OR 1.4). Among National Cardiovascular Data Registry registrants receiving first-time ICDs for primary prevention, the majority met trial-based criteria. Multivariate analyses suggested that many patients who did not meet the trial-based criteria may have had clinical circumstances that warranted ICD implantation. These findings caution against the use of trial-based indications to determine site quality metrics that could penalize sites that care for younger patients. The planned incorporation of appropriate use criteria into the ICD registry may better characterize patient- and site-level quality and performance. Published by Elsevier Inc.

The Utility of a Wireless Implantable Hemodynamic Monitoring System in Patients Requiring Mechanical Circulatory Support.

PubMed

Feldman, David S; Moazami, Nader; Adamson, Philip B; Vierecke, Juliane; Raval, Nir; Shreenivas, Satya; Cabuay, Barry M; Jimenez, Javier; Abraham, William T; O'Connell, John B; Naka, Yoshifumi

Proper timing of left ventricular assist device (LVAD) implantation in advanced heart failure patients is not well established and is an area of intense interest. In addition, optimizing LVAD performance after implantation remains difficult and represents a significant clinical need. Implantable hemodynamic monitoring systems may provide physicians with the physiologic information necessary to improve the timing of LVAD implantation as well as LVAD performance when compared with current methods. The CardioMEMS Heart sensor Allows for Monitoirng of Pressures to Improve Outcomes in NYHA Class III heart failure patients (CHAMPION) Trial enrolled 550 previously hospitalized patients with New York Heart Association (NYHA) class III heart failure. All patients were implanted with a pulmonary artery (PA) pressure monitoring system and randomized to a treatment and control groups. In the treatment group, physicians used the hemodynamic information to make heart failure management decisions. This information was not available to physicians for the control group. During an average of 18 month randomized follow-up, 27 patients required LVAD implantation. At the time of PA pressure sensor implantation, patients ultimately requiring advanced therapy had higher PA pressures, lower systemic pressure, and similar cardiac output measurements. Treatment and control patients in the LVAD subgroup had similar clinical profiles at the time of enrollment. There was a trend toward a shorter length of time to LVAD implantation in the treatment group when hemodynamic information was available. After LVAD implantation, most treatment group patients continued to provide physicians with physiologic information from the hemodynamic monitoring system. As expected PA pressures declined significantly post LVAD implant in all patients, but the magnitude of decline was higher in patients with PA pressure monitoring. Implantable hemodynamic monitoring appeared to improve the timing of LVAD implantation as well as optimize LVAD performance when compared with current methods. Further studies are necessary to evaluate these findings in a prospective manner.

In vitro and in vivo testing of a totally implantable left ventricular assist system.

PubMed

Jassawalla, J S; Daniel, M A; Chen, H; Lee, J; LaForge, D; Billich, J; Ramasamy, N; Miller, P J; Oyer, P E; Portner, P M

1988-01-01

The totally implantable Novacor LVAS is being tested under NIH auspices to demonstrate safety and efficacy before clinical trials. Twelve complete systems (submerged in saline at 37 degrees C) are being tested, with an NIH goal of demonstrating 80% reliability for 2 year operation with a 60% confidence level. The systems, which are continuously monitored, are diurnally cycled between two output levels by automatically varying preload and afterload. Currently, 14.3 years of failure-free operation have been accumulated, with a mean duration of 14 months. Using an exponential failure distribution model, the mean time to failure (MTTF) is greater than 8.8 years, corresponding to a demonstrated reliability (for a 2 year mission time) of 80% (80% confidence level). Recent ovine experiments with VAS subsystems include a 767 day volume compensator implant, a 279 day pump/drive unit implant and a 1,448 day BST implant. The last 12 chronic pump/drive unit experiments had a mean duration of 153 days (excluding early postoperative complications). This compares favorably with the NIH goals for complete systems (5 month mean duration). Complete system experiments are currently underway.

The rationale and design of the Shockless IMPLant Evaluation (SIMPLE) trial: a randomized, controlled trial of defibrillation testing at the time of defibrillator implantation.

PubMed

Healey, Jeff S; Hohnloser, Stefan H; Glikson, Michael; Neuzner, Joerg; Viñolas, Xavier; Mabo, Philippe; Kautzner, Josef; O'Hara, Gilles; Van Erven, Liselot; Gadler, Frederick; Appl, Ursula; Connolly, Stuart J

2012-08-01

Defibrillation testing (DT) has been an integral part of defibrillator (implantable cardioverter defibrillator [ICD]) implantation; however, there is little evidence that it improves outcomes. Surveys show a trend toward ICD implantation without DT, which now exceeds 30% to 60% in some regions. Because there is no evidence to support dramatic shift in practice, a randomized trial is urgently needed. The SIMPLE trial will determine if ICD implantation without any DT is noninferior to implantation with DT. Patients will be eligible if they are receiving their first ICD using a Boston Scientific device (Boston Scientific, Natick, MA). Patients will be randomized to DT or no DT at the time of ICD implantation. In the DT arm, physicians will make all reasonable efforts to ensure 1 successful intraoperative defibrillation at 17 J or 2 at 21 J. The first clinical shock in all tachycardia zones will be set to 31 J for all patients. The primary outcome of SIMPLE will be the composite of ineffective appropriate shock or arrhythmic death. The safety outcome of SIMPLE will include a composite of potentially DT-related procedural complications within 30 days of ICD implantation. Several secondary outcomes will be evaluated, including all-cause mortality and heart failure hospitalization. Enrollment of 2,500 patients with 3.5-year mean follow-up will provide sufficient statistical power to demonstrate noninferiority. The study is being performed at approximately 90 centers in Canada, Europe, Israel, and Asia Pacific with final results expected in 2013. Copyright © 2012 Mosby, Inc. All rights reserved.

Interventions for replacing missing teeth: alveolar ridge preservation techniques for dental implant site development.

PubMed

Atieh, Momen A; Alsabeeha, Nabeel H M; Payne, Alan G T; Duncan, Warwick; Faggion, Clovis M; Esposito, Marco

2015-05-28

Alveolar bone changes following tooth extraction can compromise prosthodontic rehabilitation. Alveolar ridge preservation (ARP) has been proposed to limit these changes and improve prosthodontic and aesthetic outcomes when implants are used. To assess the clinical effects of various materials and techniques for ARP after tooth extraction compared with extraction alone or other methods of ARP, or both, in patients requiring dental implant placement following healing of extraction sockets. The following electronic databases were searched: the Cochrane Oral Health Group's Trials Register (to 22 July 2014), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2014, Issue 6), MEDLINE via OVID (1946 to 22 July 2014), EMBASE via OVID (1980 to 22 July 2014), LILACS via BIREME (1982 to 22 July 2014), the Meta Register of Current Controlled Trials (to 22 July 2014), ClinicalTrials.gov (to 22 July 2014), the World Health Organization International Clinical Trials Registry Platform (to 22 July 2014), Web of Science Conference Proceedings (1990 to 22 July 2014), Scopus (1966 to 22 July 2014), ProQuest Dissertations and Theses (1861 to 22 July 2014) and OpenGrey (to 22 July 2014). A number of journals were also handsearched. Trial authors were contacted to identify unpublished randomised controlled trials. There were no restrictions regarding language and date of publication in the searches of the electronic databases. We included all randomised controlled trials (RCTs) on the use of alveolar ridge preservation techniques with at least six months of follow-up. Outcome measures were: changes in the bucco-lingual/palatal width of alveolar ridge, changes in the vertical height of the alveolar ridge, complications, the need for additional augmentation prior to implant placement, aesthetic outcomes, implant failure rates, peri-implant marginal bone level changes, changes in probing depths and clinical attachment levels at teeth adjacent to the extraction site, and complications of future prosthodontic rehabilitation. Two review authors extracted data independently and assessed risk of bias for each included trial. Corresponding authors were contacted to obtain missing information. Results were combined using random-effects models with mean differences (MD) for continuous outcomes and risk ratios (RR) for dichotomous outcomes, with 95% confidence intervals (95% CI). We constructed 'Summary of findings' tables to present the main findings. A total of 50 trials were potentially eligible for inclusion, of which 42 trials were excluded. We included eight RCTs with a total of 233 extraction sites in 184 participants. One trial was judged to be at unclear risk of bias and the remaining trials were at high risk of bias. From two trials comparing xenograft with extraction alone (70 participants, moderate quality evidence), there was some evidence of a reduction in loss of alveolar ridge height (MD -2.60 mm; 95% CI -3.43 to -1.76) and width (MD -1.97 mm; 95% CI -2.48 to -1.46). This was also found in one trial comparing allograft with extraction (24 participants, low quality evidence): ridge height (MD -2.20 mm; 95% CI -0.75 to -3.65) and width (MD - 1.40 mm; 95% CI 0.00 to -2.80) and height. From two RCTs comparing alloplast versus xenograft no evidence was found that either ridge preservation technique caused a smaller reduction in loss of ridge height (MD -0.35 mm; 95% CI -0.86 to 0.16) or width (MD -0.44 mm; 95% CI -0.90 to 0.02; two trials (55 participants); moderate quality evidence). There was insufficient evidence to determine whether there are clinically significant differences between different ARP techniques and extraction based on the need for additional augmentation prior to implant placement, complications, implant failure, or changes in peri-implant marginal bone levels and probing depths of neighbouring teeth. We found no trials which evaluated parameters relating to clinical attachment levels, specific aesthetic or prosthodontic outcomes. There is limited evidence that ARP techniques may minimise the overall changes in residual ridge height and width six months after extraction. There is also lack of evidence of any differences in implant failure, aesthetic outcomes or any other clinical parameters due to the lack of information or long-term data. There is no convincing evidence of any clinically significant difference between different grafting materials and barriers used for ARP. Further long term RCTs that follow CONSORT guidelines (www.consort-statement.org) are necessary.

Vertical ridge augmentation with autogenous bone grafts 3 years after loading: resorbable barriers versus titanium-reinforced barriers. A randomized controlled clinical trial.

PubMed

Merli, Mauro; Lombardini, Francesco; Esposito, Marco

2010-01-01

To compare the efficacy of two different techniques for vertical bone regeneration at implant placement with particulated autogenous bone at 3 years after loading: resorbable collagen barriers supported by osteosynthesis plates and nonresorbable titanium-reinforced expanded polytetrafluoroethylene barriers. Twenty-two partially edentulous patients requiring vertical bone augmentation were randomly allocated to two treatment groups, each composed of 11 patients. Prosthetic and implant failures, complications, the amount of vertically regenerated bone, and peri-implant marginal bone levels were recorded by independent and blinded assessors. The implant site requiring the most vertical bone regeneration was selected in each patient for bone level assessment. The follow-up time ranged from provisional loading to 3 years after loading. Analysis of covariance and paired t tests were conducted to compare means at the .05 level of significance. No patient dropped out or was excluded at the 3-year follow-up. No prosthetic failures and no implant failures or complications occurred after loading. There was no statistically significant difference in bone loss between the two groups at either 1 year or 3 years. Both groups had gradually lost a statistically significant amount of peri-implant bone at 1 and 3 years (P < .05). After 3 years, patients treated with resorbable barriers had lost a mean of 0.55 mm of bone; patients who had received nonresorbable barriers showed a mean of 0.53 mm of bone loss. Up to 3 years after implant loading, no failures or complications occurred and peri-implant marginal bone loss was minimal. Vertically regenerated bone can be successfully maintained after functional loading.

Frequency of pneumothorax and haemothorax after primary open versus closed implantation strategies for insertion of a totally implantable venous access port in oncological patients: study protocol for a randomised controlled trial.

PubMed

Hüttner, Felix J; Bruckner, Tom; Alldinger, Ingo; Hennes, Roland; Ulrich, Alexis; Büchler, Markus W; Diener, Markus K; Knebel, Phillip

2015-03-31

The insertion of central venous access devices, such as totally implantable venous access ports (TIVAPs), is routine in patients who need a safe and permanent venous access. The number of port implantations is increasing due to the development of innovative adjuvant and neo-adjuvant therapies. Currently, two different strategies are being routinely used: surgical cut-down of the cephalic vein (vena section) and direct puncture of the subclavian vein. The aim of this trial is to identify the strategy for the implantation of TIVAPs with the lowest risk of pneumothorax and haemothorax. The PORTAS-3 trial is designed as a multicentre, randomised controlled trial to compare two implantation strategies. A total of 1,154 patients will be randomised after giving written informed consent. Patients must be over 18 years of age and scheduled for primary implantation of a TIVAP on the designated side. The primary endpoint will be the frequency of pneumothorax and haemothorax after insertion of a TIVAP by one of two different strategies. The experimental intervention is as follows: open strategy, defined as surgical cut-down of the cephalic vein, supported by a rescue technique if necessary, and in the case of failure, direct puncture of the subclavian vein. The control intervention is as follows: direct puncture of the subclavian vein using the Seldinger technique guided by sonography, fluoroscopy or landmark technique. The trial duration is approximately 36 months, with a recruitment period of 18 months and a follow-up period of 30 days. The PORTAS-3 trial will compare two different TIVAP implantation strategies with regard to their individual risk of postoperative pneumothorax and haemothorax. Since TIVAP implantation is one of the most common procedures in general surgery, the results will be of interest for a large community of surgeons as well as oncologists and general practitioners. The pragmatic trial design ensures that the results will be generalizable to a wide range of patients. The trial protocol was registered on 28 August 2014 with the German Clinical Trials Register (DRKS00004900) . The World Health Organization's Universal Trial Number is U1111-1142-4420.

The natural history of new-onset heart failure with a severely depressed left ventricular ejection fraction: implications for timing of implantable cardioverter-defibrillator implantation.

PubMed

Teeter, William A; Thibodeau, Jennifer T; Rao, Krishnasree; Brickner, M Elizabeth; Toto, Kathleen H; Nelson, Lauren L; Mishkin, Joseph D; Ayers, Colby R; Miller, Justin G; Mammen, Pradeep P A; Patel, Parag C; Markham, David W; Drazner, Mark H

2012-09-01

Guidelines recommend that patients with new-onset systolic heart failure (HF) receive a trial of medical therapy before an implantable cardiac defibrillator (ICD). This strategy allows for improvement of left ventricular ejection fraction (LVEF), thereby avoiding an ICD, but exposes patients to risk of potentially preventable sudden cardiac death during the trial of medical therapy. We reviewed a consecutive series of patients with HF of <6 months duration with a severely depressed LVEF (<30%) evaluated in a HF clinic (N = 224). The ICD implantation was delayed with plans to reassess LVEF approximately 6 months after optimization of β-blockers. Mortality was ascertained by the National Death Index. Follow-up echocardiograms were performed in 115 of the 224 subjects. Of these, 50 (43%) had mildly depressed or normal LVEF at follow-up ("LVEF recovery") such that an ICD was no longer indicated. In a conservative sensitivity analysis (using the entire study cohort, whether or not a follow-up echocardiogram was obtained, as the denominator), 22% of subjects had LVEF recovery. Mortality at 6, 12, and 18 months in the entire cohort was 2.3%, 4.5%, and 6.8%, respectively. Of 87 patients who tolerated target doses of β-blockers, only 1 (1.1%) died during the first 18 months. Patients with new-onset systolic HF have both a good chance of LVEF recovery and low 6-month mortality. Achievement of target β-blocker dose identifies a very low-risk population. These data support delaying ICD implantation for a trial of medical therapy. Copyright © 2012 Mosby, Inc. All rights reserved.

Design of the evolution of management strategies of heart failure patients with implantable defibrillators (EVOLVO) study to assess the ability of remote monitoring to treat and triage patients more effectively

PubMed Central

Marzegalli, Maurizio; Landolina, Maurizio; Lunati, Maurizio; Perego, Giovanni B; Pappone, Alessia; Guenzati, Giuseppe; Campana, Carlo; Frigerio, Maria; Parati, Gianfranco; Curnis, Antonio; Colangelo, Irene; Valsecchi, Sergio

2009-01-01

Background Heart failure patients with implantable defibrillators (ICD) frequently visit the clinic for routine device monitoring. Moreover, in the case of clinical events, such as ICD shocks or alert notifications for changes in cardiac status or safety issues, they often visit the emergency department or the clinic for an unscheduled visit. These planned and unplanned visits place a great burden on healthcare providers. Internet-based remote device interrogation systems, which give physicians remote access to patients' data, are being proposed in order to reduce routine and interim visits and to detect and notify alert conditions earlier. Methods The EVOLVO study is a prospective, randomized, parallel, unblinded, multicenter clinical trial designed to compare remote ICD management with the current standard of care, in order to assess its ability to treat and triage patients more effectively. Two-hundred patients implanted with wireless-transmission-enabled ICD will be enrolled and randomized to receive either the Medtronic CareLink® monitor for remote transmission or the conventional method of in-person evaluations. The purpose of this manuscript is to describe the design of the trial. The results, which are to be presented separately, will characterize healthcare utilizations as a result of ICD follow-up by means of remote monitoring instead of conventional in-person evaluations. Trial registration ClinicalTrials.gov: NCT00873899 PMID:19538734

Cement augmentation of the Proximal Femoral Nail Antirotation (PFNA) - A multicentre randomized controlled trial.

PubMed

Kammerlander, Christian; Hem, Einar S; Klopfer, Tim; Gebhard, Florian; Sermon, An; Dietrich, Michael; Bach, Olaf; Weil, Yoram; Babst, Reto; Blauth, Michael

2018-04-22

New implant designs like the Proximal Femoral Nail Antirotation (PFNA) were developed to reduce failure rates in unstable pertrochanteric fractures in the elderly. Standardized implant augmentation with up to 6 mL of polymethylmethacrylate (PMMA) cement has been introduced to enhance implant anchorage by increasing the implant-bone interface in osteoporotic bone conditions. Biomechanically, loads to failure were significantly higher with augmentation. The primary objective of this study was to compare the mobility of patients with closed unstable trochanteric fractures treated by PFNA either with or without cement augmentation. A prospective multicentre, randomized, patient-blinded trial was conducted with ambulatory patients aged 75 or older who sustained a closed, unstable trochanteric fracture. Surgical fixation had to be performed within 72 h after admission. Outcomes were evaluated at baseline, during surgery, 3 to 14 days after surgery, 3 months, 6 months, and 12 months after surgery. To evaluate the primary objective, patients' walking speed was assessed by the Timed Up and Go (TUG) test. Secondary objectives included the analysis of implant migration assessed on radiographs, quality of life measured by the Barthel Index, mobility measured by the Parker Mobility Score, and complications. Of 253 randomized patients, 223 patients were eligible: 105 patients were allocated to the PFNA Augmentation group and 118 to PFNA group. At 3 to 14 days after surgery, there was no statistical significant difference in mean walking speed between the treatment groups. For the secondary objectives, also no statistical significant differences were found. However, no patient in the PFNA Augmentation group had a reoperation due to mechanical failure or symptomatic implant migration compared to 6 patients in the PFNA group. Augmentation of the PFNA blade did not improve patients' walking ability compared to the use of a non-augmented PFNA but might have the potential to prevent reoperations by strengthening the osteosynthesis construct. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

Ten-year NEDO BVAD development program: moving forward to the clinical arena.

PubMed

Motomura, Tadashi; Okubo, Hisashi; Oda, Takeshi; Ogawa, Daisuke; Okahisa, Toshiya; Igo, Stephen; Shinohara, Toshiyuki; Yamamoto, Yoshiro; Noguchi, Chikaya; Ishizuka, Tsukasa; Okamoto, Eiji; Nosé, Yukihiko

2006-01-01

Since 1995, the Baylor Group has been developing a totally implantable NEDO BVAD system. This 10-year program was completed in March 2005, and preparation for clinical trials is underway. This article summarizes the entire 10-year NEDO program and describes the strategy for clinical trials. The project aimed to achieve: (1) dual centrifugal pumps with the ability of full biventricular support, (2) a compact system implantable into small adults, (3) a totally implantable system with transcutaneous energy transmission system (TETS), (4) a durable system with a lifetime of over 5 years, and (5) a system free of thrombus and with minimal hemolysis. The final goals are to complete preclinical system evaluations and commence the clinical trials in the near future. In vitro studies have demonstrated a pump capacity of over 8.5 l/min and an Index of Hemolysis of <0.004 g/100 l. The pump-bearing life expectancy was over 5 years. To date, eight pumps endured in vivo studies of over 3 months without complications, including thromboembolic events. The in vitro endurance studies of eight pumps are longer than 1 year. There were no mechanical malfunctions or pump failure. A stepwise clinical trial is being planned: Step1, a wearable BVAD/VAD will be clinically studied; Step 2, the BVAD/VAD will be implanted intracorporeally without TETS; and, Step 3, a totally implantable system will be clinically evaluated. The NEDO BVAD system has completed preclinical testing. Clinical trial preparation is underway.

Bar versus ball attachments for implant-supported overdentures in complete edentulism: A systematic review.

PubMed

Anas El-Wegoud, Marwah; Fayyad, Ahmed; Kaddah, Amal; Nabhan, Ashraf

2018-04-01

Implant-supported overdenture is one of the most predictable treatment options used in complete edentulism. However, differences have been reported between bar and ball attachments used to retain overdentures in terms of patient satisfaction and prosthesis retention. The purpose of this study is to compare the effectiveness of bar and ball attachments for conventionally loaded implant-supported overdentures in completely edentulous patients to improve patient satisfaction and prosthesis retention. We conducted the review according to the Cochrane methods and following MECIR standards. We searched Cochrane Oral Health Group Trial register, Cochrane Central Register of Controlled Trials, MEDLINE, and the WHO ICTRP (March 31, 2017). Two review authors assessed trials for inclusion and risk of bias, extracted data, and checked for accuracy. We have expressed results as risk ratio or mean differences, together with their 95% confidence intervals. We included 10 trials (465 participants). After 5 y, one trial reported higher patient satisfaction when bar attachment was used (MD 1.30, 95% CI 0.20-2.40), and reported no difference between both systems in prosthesis retention (MD -0.90, 95% CI -1.90 to 0.10). Two trials reported no implant failures after 1 and 5 y in both attachments. Downgrading of evidence was based on the unclear risk of bias of included studies and the wide CI crossing the line of no effect. There is insufficient evidence to support bar or ball attachment to be used with implant-supported overdentures in completely edentulous patients to improve patient satisfaction and prosthesis retention (PROSPERO 2014:CRD42014014594). © 2017 Wiley Periodicals, Inc.

Bioabsorbable versus metallic interference screws for graft fixation in anterior cruciate ligament reconstruction.

PubMed

Debieux, Pedro; Franciozi, Carlos E S; Lenza, Mário; Tamaoki, Marcel Jun; Magnussen, Robert A; Faloppa, Flávio; Belloti, João Carlos

2016-07-24

Anterior cruciate ligament (ACL) tears are frequently treated with surgical reconstruction with grafts, frequently patella tendon or hamstrings. Interference screws are often used to secure the graft in bone tunnels in the femur and tibia. This review examines whether bioabsorbable interference screws give better results than metal interference screws when used for graft fixation in ACL reconstruction. To assess the effects (benefits and harms) of bioabsorbable versus metallic interference screws for graft fixation in ACL reconstruction. We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, CENTRAL (the Cochrane Library), MEDLINE, Embase, LILACS, trial registers and reference lists of articles. Date of search: January 2016. We included randomised controlled trials and quasi-randomised trials comparing bioabsorbable with metallic interferences screws in ACL reconstruction. The main outcomes sought were subjective-rated knee function, failure of treatment, and activity level. At least two review authors selected eligible trials, independently assessed risk of bias, and cross-checked data. Data were pooled whenever relevant and possible. Requests for further information were sent to the original study authors. We included 12 trials (11 randomised and one quasi-randomised) involving a total of 944 participants, and reporting follow-up results for 774. Participants in the 12 trials underwent ACL reconstruction with either hamstring tendon grafts (five trials) or patellar tendon grafts (seven trials). Trials participants were randomly allocated to bioabsorbable or metallic interference screws for graft fixation in both femur and tibia (seven trials); femur only (three trials); tibia only (one trial); location was not reported in the remaining trial. A variety of materials was used for the bioabsorbable screws, Poly-L-lactic acid (PLLA) being the most common. The metallic screws, where reported, were titanium.All trials were at high risk of bias, which invariably included performance bias. Seven trials were at high risk of attrition bias and eight at high risk of reporting bias. The quasi-randomised trial was assessed as being at high risk for selection bias. Based on these study limitations and insufficiency of the available data, we judged the quality of evidence for all outcomes was very low.The majority of the available data for patient-reported knee function was presented as Lysholm scores (0 to 100; higher scores = better function). There was very low quality but consistent evidence of no clinically important differences between the two groups in Lysholm scores at 12 months follow-up (mean difference (MD) -0.08, 95% confidence interval (CI) -1.48 to 1.32; three trials, 168 participants); 24 months (MD 0.35, 95% CI -1.27 to 1.98; three trials, 113 participants) or five or more years follow-up (MD 1.23, 95% CI -2.00 to 4.47; two trials, 71 participants). This lack of between-group differences was also reported for Lysholm scores in several trials that did not provide sufficient data for pooling as well as for other self-reported knee function scores reported in several trials.Treatment failure was represented by the summed data for implant breakage during surgery and major postoperative complications (implant failure, graft rupture, symptomatic foreign body reactions, effusion and treated arthrofibrosis and related conditions) that were usually described in the trial reports as requiring further substantive treatment. There is very low-quality evidence of greater treatment failure in the bioabsorbable screw group (60/451 versus 29/434; risk ratio (RR) 1.94 favouring metallic screw fixation, 95% CI 1.29 to 2.93; 885 participants, 11 studies). In a population with an assumed risk (based on the median control group risk) of 56 participants per 1000 having treatment failure after metallic screw fixation, this equates to 53 more (95% CI 17 to 108 more) per 1000 participants having treatment failure after bioabsorbable screw fixation. All 16 intraoperative complications in the bioabsorbable screw group were implant breakages upon screw insertion. Treatment failure defined as postoperative complications only still favoured the metallic screw group but the 95% CI also included the potential for a greater risk of treatment failure after metallic screw fixation: 44/451 versus 29/434; RR 1.44, 95% CI 0.93 to 2.23. Based on the assumed risk of 56 participants per 1000 having postoperative treatment failure after metallic screw fixation, this equates to 25 more (95% CI 4 fewer and 69 more) per 1000 participants having this outcome after bioabsorbable screw fixation.There was very low-quality evidence of very similar activity levels in the two groups at 12 and 24 months follow-up measured via the Tegner score (0 to 10; higher scores = greater activity): 12 months (MD 0.08, 95% CI -0.39 to 0.55; 122 participants, two studies); 24 months (MD 0.01, 95% CI -0.54 to 0.57; 72 participants, two studies). There is very low-quality evidence of no difference in self-reported knee function and levels of activity between bioabsorbable and metallic interference screws for graft fixation in ACL reconstruction. There is very low-quality evidence that bioabsorbable screws may be associated with more overall treatment failures, including implant breakage during surgery. Further research does not appear to be a priority, but if undertaken, should also examine costs.

Fractography of clinically fractured, implant-supported dental computer-aided design and computer-aided manufacturing crowns

PubMed Central

Lohbauer, Ulrich; Belli, Renan; Cune, Marco S; Schepke, Ulf

2017-01-01

Today, a substantial part of the dental crown production uses computer-aided design and computer-aided manufacturing (CAD/CAM) technology. A recent step in restorative dentistry is the replacement of natural tooth structure with pre-polymerized and machined resin-based methacrylic polymers. Recently, a new CAD/CAM composite was launched for the crown indication in the load-bearing area, but the clinical reality forced the manufacturer to withdraw this specific indication. In parallel, a randomized clinical trial of CAD/CAM composite crowns luted on zirconia implant abutments revealed a high incidence of failure within the first year of service. Fractured crowns of this clinical trial were retrieved and submitted to a fractographic examination. The aim of the case series presented in this article was to identify failure reasons for a new type of CAD/CAM composite crown material (Lava Ultimate; 3M Oral Care, St. Paul, Minnesota, USA) via fractographic examinations and analytical assessment of luting surfaces and water absorption behavior. As a result, the debonding of the composite crowns from the zirconia implant abutments was identified as the central reason for failure. The adhesive interface was found the weakest link. A lack of silica at the zirconia surface certainly has compromised the bonding potential of the adhesive system from the beginning. Additionally, the hydrolytic stress released from swelling of the resin-based crown (water absorption) and transfer to the luting interface further added to the interfacial stress and most probably contributed to a great extend to the debonding failure. PMID:29204275

Fractography of clinically fractured, implant-supported dental computer-aided design and computer-aided manufacturing crowns.

PubMed

Lohbauer, Ulrich; Belli, Renan; Cune, Marco S; Schepke, Ulf

2017-01-01

Today, a substantial part of the dental crown production uses computer-aided design and computer-aided manufacturing (CAD/CAM) technology. A recent step in restorative dentistry is the replacement of natural tooth structure with pre-polymerized and machined resin-based methacrylic polymers. Recently, a new CAD/CAM composite was launched for the crown indication in the load-bearing area, but the clinical reality forced the manufacturer to withdraw this specific indication. In parallel, a randomized clinical trial of CAD/CAM composite crowns luted on zirconia implant abutments revealed a high incidence of failure within the first year of service. Fractured crowns of this clinical trial were retrieved and submitted to a fractographic examination. The aim of the case series presented in this article was to identify failure reasons for a new type of CAD/CAM composite crown material (Lava Ultimate; 3M Oral Care, St. Paul, Minnesota, USA) via fractographic examinations and analytical assessment of luting surfaces and water absorption behavior. As a result, the debonding of the composite crowns from the zirconia implant abutments was identified as the central reason for failure. The adhesive interface was found the weakest link. A lack of silica at the zirconia surface certainly has compromised the bonding potential of the adhesive system from the beginning. Additionally, the hydrolytic stress released from swelling of the resin-based crown (water absorption) and transfer to the luting interface further added to the interfacial stress and most probably contributed to a great extend to the debonding failure.

Pediatric experience with the VentrAssist LVAD.

PubMed

Ruygrok, Peter N; Esmore, Don S; Alison, Peter M; Finucane, Kirsten A; McGuinness, Shay P; McGeorge, Alastair D; Negri, Justin; Jones, Kylie; Gibbs, Helen C

2008-08-01

The purpose of this study is to describe the first experience of implanting a new left ventricular assist device in pediatric patients with end-stage heart failure. In two recent prospective, international, multicenter clinical trials, three children (aged

Soft tissue management for dental implants: what are the most effective techniques? A Cochrane systematic review.

PubMed

Esposito, Marco; Maghaireh, Hassan; Grusovin, Maria Gabriella; Ziounas, Ioannis; Worthington, Helen V

2012-01-01

This review is based on a Cochrane systematic review entitled 'Interventions for replacing missing teeth: management of soft tissues for dental implants' published in The Cochrane Library (see http:// www.cochrane.org/ for information). Cochrane systematic reviews are regularly updated to include new research, and in response to comments and criticisms from readers. If you wish to comment on this review, please send your comments to the Cochrane website or to Marco Esposito. The Cochrane Library should be consulted for the most recent version of the review. The results of a Cochrane review can be interpreted differently, depending on people's perspectives and circumstances. Please consider the conclusions presented carefully. They are the opinions of the review authors, and are not necessarily shared by the Cochrane Collaboration. To evaluate whether flapless procedures are beneficial for patients and which is the ideal flap design, whether soft tissue correction/augmentation techniques are beneficial for patients and which are the best techniques, whether techniques to increase the peri-implant keratinised mucosa are beneficial for patients and which are the best techniques, and which are the best suturing techniques/ materials. The Cochrane Oral Health Group's Trials Register, CENTRAL, MEDLINE and EMBASE were searched up to the 9th of June 2011 for randomised controlled trials (RCTs) of rootform osseointegrated dental implants, with a follow-up of at least 6 months after function, comparing various techniques to handle soft tissues in relation to dental implants. Primary outcome measures were prosthetic failures, implant failures and biological complications. Screening of eligible studies, assessment of the methodological quality of the trials and data extraction were conducted at least in duplicate and independently by two or more review authors. The statistical unit was the patient and not the prosthesis, the procedure or the implant. RESULTS were expressed using risk ratios for dichotomous outcomes and mean differences for continuous outcomes with 95% confidence intervals (CI). Seventeen potentially eligible RCTs were identified but only six trials with 138 patients in total could be included. The following techniques were compared in the six included studies: flapless placement of dental implants versus conventional flap elevation (2 trials, 56 patients), crestal versus vestibular incisions (1 trial, 10 patients), Erbium:YAG laser versus flap elevation at the second-stage surgery for implant exposure (1 trial, 20 patients), whether a connective tissue graft at implant placement could be effective in augmenting peri-implant tissues (1 split-mouth trial, 10 patients), and autograft versus an animal-derived collagen matrix to increase the height of the keratinised mucosa (1 trial, 40 patients). On a patient rather than per implant basis, implants placed with a flapless technique and implant exposures performed with laser lead to statistically significantly less postoperative pain than flap elevation. Sites augmented with soft tissue connective grafts had better aesthetics and thicker tissues. Both palatal autografts or the use of a porcine-derived collagen matrix are effective in increasing the height of keratinised mucosa at the cost of a 0.5 mm recession of peri-implant soft tissues. There were no other statistically significant differences for any of the remaining analyses. There is limited weak evidence suggesting that flapless implant placement is feasible and has been shown to reduce patient postoperative discomfort in adequately selected patients, that augmentation at implant sites with soft tissue grafts is effective in increasing soft tissue thickness and improving aesthetics, and that one technique to increase the height of keratinised mucosa using autografts or an animal-derived collagen matrix was able to achieve its goal but at the cost of a worsened aesthetic outcome (0.5 mm of recession). There is insufficient reliable evidence to provide recommendations on which is the ideal flap design, the best soft tissue augmentation technique, whether techniques to increase the width of keratinised/attached mucosa are beneficial to patients or not, and which are the best incision/suture techniques/materials. Properly designed and conducted RCTs, with at least 6 months of follow-up, are needed to provide reliable answers to these questions.

Investigational Clinical Trial of a Prototype Optoelectronic Computer-Aided Navigation Device for Dental Implant Surgery.

PubMed

Jokstad, Asbjørn; Winnett, Brenton; Fava, Joseph; Powell, David; Somogyi-Ganss, Eszter

New digital technologies enable real-time computer-aided (CA) three-dimensional (3D) guidance during dental implant surgery. The aim of this investigational clinical trial was to demonstrate the safety and effectiveness of a prototype optoelectronic CA-navigation device in comparison with the conventional approach for planning and effecting dental implant surgery. Study participants with up to four missing teeth were recruited from the pool of patients referred to the University of Toronto Graduate Prosthodontics clinic. The first 10 participants were allocated to either a conventional or a prototype device study arm in a randomized trial. The next 10 participants received implants using the prototype device. All study participants were restored with fixed dental prostheses after 3 (mandible) or 6 (maxilla) months healing, and monitored over 12 months. The primary outcome was the incidence of any surgical, biologic, or prosthetic adverse events or device-related complications. Secondary outcomes were the incidence of positioning of implants not considered suitable for straightforward prosthetic restoration (yes/no); the perception of the ease of use of the prototype device by the two oral surgeons, recorded by use of a Likert-type questionnaire; and the clinical performance of the implant and superstructure after 1 year in function. Positioning of the implants was appraised on periapical radiographs and clinical photographs by four independent blinded examiners. Peri-implant bone loss was measured on periapical radiographs by a blinded examiner. No adverse events occurred related to placing any implants. Four device-related complications led to a switch from using the prototype device to the conventional method. All implants placed by use of the prototype device were in a position considered suitable for straightforward prosthetic restoration (n = 21). The qualitative evaluation by the surgeons was generally positive, although ergonomic challenges were identified. All study participants were present for the 1-year examination (n = 20 patients, 41 implants, 32 superstructures), and no complications or failures with any implants or superstructures were revealed. The peri-implant bone loss was less than 1 mm for all implants. Within the limitations of this trial, the prototype device provided placement of dental implants without adverse events.

Effects of remote monitoring on clinical outcomes and use of healthcare resources in heart failure patients with biventricular defibrillators: results of the MORE-CARE multicentre randomized controlled trial.

PubMed

Boriani, Giuseppe; Da Costa, Antoine; Quesada, Aurelio; Ricci, Renato Pietro; Favale, Stefano; Boscolo, Gabriele; Clementy, Nicolas; Amori, Valentina; Mangoni di S Stefano, Lorenza; Burri, Haran

2017-03-01

The aim of this study was to evaluate the clinical efficacy and safety of remote monitoring in patients with heart failure implanted with a biventricular defibrillator (CRT-D) with advanced diagnostics. The MORE-CARE trial is an international, prospective, multicentre, randomized controlled trial. Within 8 weeks of de novo implant of a CRT-D, patients were randomized to undergo remote checks alternating with in-office follow-ups (Remote arm) or in-office follow-ups alone (Standard arm). The primary endpoint was a composite of death and cardiovascular (CV) and device-related hospitalization. Use of healthcare resources was also evaluated. A total of 865 eligible patients (mean age 66 ± 10 years) were included in the final analysis (437 in the Remote arm and 428 in the Standard arm) and followed for a median of 24 (interquartile range = 15-26) months. No significant difference was found in the primary endpoint between the Remote and Standard arms [hazard ratio 1.02, 95% confidence interval (CI) 0.80-1.30, P = 0.89] or in the individual components of the primary endpoint (P > 0.05). For the composite endpoint of healthcare resource utilization (i.e. 2-year rates of CV hospitalizations, CV emergency department admissions, and CV in-office follow-ups), a significant 38% reduction was found in the Remote vs. Standard arm (incidence rate ratio 0.62, 95% CI 0.58-0.66, P < 0.001) mainly driven by a reduction of in-office visits. In heart failure patients implanted with a CRT-D, remote monitoring did not reduce mortality or risk of CV or device-related hospitalization. Use of healthcare resources was significantly reduced as a result of a marked reduction of in-office visits without compromising patient safety. NCT00885677. © 2016 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.

Irradiated patients and survival rate of dental implants: A systematic review and meta-analysis.

PubMed

Smith Nobrega, Adhara; Santiago, Joel Ferreira; de Faria Almeida, Daniel Augusto; Dos Santos, Daniela Micheline; Pellizzer, Eduardo Piza; Goiato, Marcelo Coelho

2016-12-01

Radiotherapy has been considered a contraindication for rehabilitation with dental implants because it can change the survival rate of implants. Nevertheless, the installation of implants in irradiated patients has been used with varying success. The purpose of this systematic review was to compare the success rate of implants placed in irradiated human bone tissue with that of implants placed in nonirradiated areas. Searches were performed in the EMBASE, Cochrane, and PubMed/Medline databases up to December 2013 to identify clinical trials addressing the subject. This systematic review was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The relative risks of implant failure and survival curves were calculated considering a confidence interval of 95%. Heterogeneity was analyzed by using a funnel chart. A total of 40 studies involving 2220 participants and 9231 dental implants were selected. The survival curve of the studies indicated a survival rate of 84.3% for implants installed in irradiated bone tissue. The meta-analysis indicated statistically significant differences (P<.001) between item success rates of implants placed in irradiated areas and those of implants placed in nonirradiated areas. Dental implants installed in the irradiated area of an oral cavity have a high survival rate, but strict monitoring is needed to prevent complications, thereby reducing possible failures. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Double valve replacement in a patient with implantable cardioverter defibrillator with severe left ventricular dysfunction.

PubMed

Manjunath, Girish; Rao, Prakash; Prakash, Nagendra; Shivaram, B K

2016-01-01

Recent data from landmark trials suggest that the indications for cardiac pacing and implantable cardioverter defibrillators (ICDs) are set to expand to include heart failure, sleep-disordered breathing, and possibly routine implantation in patients with myocardial infarction and poor ventricular function.[1] This will inevitably result in more patients with cardiac devices undergoing surgeries. Perioperative electromagnetic interference and their potential effects on ICDs pose considerable challenges to the anesthesiologists.[2] We present a case of a patient with automatic ICD with severe left ventricular dysfunction posted for double valve replacement.

Five-year Treatment Outcomes in the Ahmed Baerveldt Comparison Study

PubMed Central

Budenz, Donald L.; Barton, Keith; Gedde, Steven J.; Feuer, William J.; Schiffman, Joyce; Costa, Vital P.; Godfrey, David G.; Buys, Yvonne M.

2014-01-01

Purpose To compare the five year outcomes of the Ahmed FP7 Glaucoma Valve (AGV) and the Baerveldt 101-350 Glaucoma Implant (BGI) for the treatment of refractory glaucoma. Design Multicenter randomized controlled clinical trial. Participants 276 patients, including 143 in the AGV group and 133 in the BGI group. Methods Patients 18 to 85 years of age with previous intraocular surgery or refractory glaucoma and intraocular pressure (IOP) of ≥ 18 mmHg in whom glaucoma drainage implant surgery was planned were randomized to implantation of either an AGV or BGI. Main Outcome Measures IOP, visual acuity, use of glaucoma medications, complications, and failure (IOP > 21 mmHg or not reduced by 20% from baseline, IOP ≤ 5 mmHg, reoperation for glaucoma, removal of implant, or loss of light perception). Results At 5 years, IOP (mean ± SD) was 14.7 ± 4.4 mmHg in the AGV group and 12.7 ± 4.5 mmHg in the BGI group (p = 0.012). The number of glaucoma medications in use at 5 years (mean ± SD) was 2.2 ± 1.4 in the AGV group and 1.8 ± 1.5 in the BGI group (p = 0.28). The cumulative probability of failure during 5 years of follow-up was 44.7% in the AGV group and 39.4% in the BGI group (p = 0.65). The number of subjects failing due to inadequately controlled IOP or reoperation for glaucoma was 46 in the AGV group (80% of AGV failures) and 25 in the BGI group (53% of BGI failures, p=0.003). Eleven AGV eyes (20% of AGV failures) experienced persistent hypotony, explantation of implant, or loss of light perception compared to 22 (47% of failures) in the BGI group. The 5-year cumulative reoperation rate for glaucoma was 20.8% in the AGV group compared to 8.6% in the BGI group (p=0.010). Change in logMAR Snellen visual acuity (mean ± SD) at 5 years was 0.42 ± 0.99 in the AGV group and 0.43 ± 0.84 in the BGI group (p=0.97). Conclusions Similar rates of surgical success were observed with both implants at 5 years. BGI implantation produced greater IOP reduction and a lower rate of glaucoma reoperation than AGV implantation but BGI implantation was associated with twice as many failures due to safety issues such as persistent hypotony, loss of light perception, or explantation. PMID:25439606

Long-Term Results of a Phase II Trial of Ultrasound-Guided Radioactive Implantation of the Prostate for Definitive Management of Localized Adenocarcinoma of the Prostate (RTOG 98-05)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lawton, Colleen A., E-mail: clawton@mcw.edu; Hunt, Daniel; Lee, W. Robert

2011-09-01

Purpose: To evaluate the long-term effectiveness of transrectal ultrasound-guided permanent radioactive I{sup 125} implantation of the prostate for organ confined adenocarcinoma of the prostate compared with historical data of prostatectomy and external beam radiotherapy within a cooperative group setting. Methods and Materials: Patients accrued to this study had histologically confirmed, locally confined adenocarcinoma of the prostate clinical stage T1b, T1c, or T2a; no nodal or metastatic disease; prostate-specific antigen level of {<=}10 ng/ml; and a Gleason score of {<=}6. All patients underwent transrectal ultrasound-guided radioactive I{sup 125} seed implantation into the prostate. The prescribed dose was 145 Gy to themore » prostate planning target volume. Results: A total of 101 patients from 27 institutions were accrued to this protocol; by design, no single institution accrued more than 8 patients. There were 94 eligible patients. The median follow up was 8.1 years (range, 0.1-9.2 years). After 8 years, 8 patients had protocol-defined biochemical (prostate-specific antigen) failure (cumulative incidence, 8.0%); 5 patients had local failure (cumulative incidence, 5.5%); and 1 patient had distant failure (cumulative incidence, 1.1%; this patient also had biochemical failure and died of causes not related to prostate cancer). The 8-year overall survival rate was 88%. At last follow-up, no patient had died of prostate cancer or related toxicities. Three patients had maximum late toxicities of Grade 3, all of which were genitourinary. No Grade 4 or 5 toxicities were observed. Conclusions: The long-term results of this clinical trial have demonstrated that this kind of trial can be successfully completed through the RTOG and that results in terms of biochemical failure and toxicity compare very favorably with other brachytherapy published series as well as surgical and external beam radiotherapy series. In addition, the prospective, multicenter design highlights the probable generalizability of the outcomes.« less

Comparing Short Dental Implants to Standard Dental Implants: Protocol for a Systematic Review.

PubMed

Rokn, Amir Reza; Keshtkar, Abbasali; Monzavi, Abbas; Hashemi, Kazem; Bitaraf, Tahereh

2018-01-18

Short dental implants have been proposed as a simpler, cheaper, and faster alternative for the rehabilitation of atrophic edentulous areas to avoid the disadvantages of surgical techniques for increasing bone volume. This review will compare short implants (4 to 8 mm) to standard implants (larger than 8 mm) in edentulous jaws, evaluating on the basis of marginal bone loss (MBL), survival rate, complications, and prosthesis failure. We will electronically search for randomized controlled trials comparing short dental implants to standard dental implants in the following databases: PubMed, Web of Science, EMBASE, Scopus, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov with English language restrictions. We will manually search the reference lists of relevant reviews and the included articles in this review. The following journals will also be searched: European Journal of Oral Implantology, Clinical Oral Implants Research, and Clinical Implant Dentistry and Related Research. Two reviewers will independently perform the study selection, data extraction and quality assessment (using the Cochrane Collaboration tool) of included studies. All meta-analysis procedures including appropriate effect size combination, sub-group analysis, meta-regression, assessing publication or reporting bias will be performed using Stata (Statacorp, TEXAS) version 12.1. Short implant effectiveness will be assessed using the mean difference of MBL in terms of weighted mean difference (WMD) and standardized mean difference (SMD) using Cohen's method. The combined effect size measures in addition to the related 95% confidence intervals will be estimated by a fixed effect model. The heterogeneity of the related effect size will be assessed using a Q Cochrane test and I2 measure. The MBL will be presented by a standardized mean difference with a 95% confidence interval. The survival rate of implants, prostheses failures, and complications will be reported using a risk ratio at 95% confidence interval (P<.05). The present protocol illustrates an appropriate method to perform the systematic review and ensures transparency for the completed review. The results will be published in a peer-reviewed journal and social networks. In addition, an ethics approval is not considered necessary. PROSPERO registration number: CRD42016048363; https://www.crd.york.ac.uk/PROSPERO/ display_record.asp?ID=CRD42016048363 (Archived by WebCite at http://www.webcitation.org/6wZ7Fntry). ©Amir Reza Rokn, Abbasali Keshtkar, Abbas Monzavi, Kazem Hashemi, Tahereh Bitaraf. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 18.01.2018.

Understanding the C-pulse device and its potential to treat heart failure.

PubMed

Sales, Virna L; McCarthy, Patrick M

2010-03-01

The Sunshine Heart C-Pulse (C-Pulse; Sunshine Heart Inc., Tustin, CA) device is an extra-aortic implantable counterpulsation pump designed as a non-blood contacting ambulatory heart assist device, which may provide relief from symptoms for class II-III congestive heart failure patients. It has a comparable hemodynamic augmentation to intra-aortic balloon counterpulsation devices. The C-Pulse cuff is implanted through a median sternotomy, secured around the ascending aorta, and pneumatically driven by an external system controller. Pre-clinical studies in the acute pig model, and initial temporary clinical studies in patients undergoing off-pump coronary bypass surgery have shown substantial increase in diastolic perfusion of the coronary vessels, which translated to a favorable improvement in ventricular function. A U.S. prospective multi-center trial to evaluate the safety and efficacy of the C-Pulse in class III patients with moderate heart failure is now in progress.

Safety and feasibility of pulmonary artery pressure-guided heart failure therapy: rationale and design of the prospective CardioMEMS Monitoring Study for Heart Failure (MEMS-HF).

PubMed

Angermann, Christiane E; Assmus, Birgit; Anker, Stefan D; Brachmann, Johannes; Ertl, Georg; Köhler, Friedrich; Rosenkranz, Stephan; Tschöpe, Carsten; Adamson, Philip B; Böhm, Michael

2018-05-19

Wireless monitoring of pulmonary artery (PA) pressures with the CardioMEMS HF™ system is indicated in patients with New York Heart Association (NYHA) class III heart failure (HF). Randomized and observational trials have shown a reduction in HF-related hospitalizations and improved quality of life in patients using this device in the United States. MEMS-HF is a prospective, non-randomized, open-label, multicenter study to characterize safety and feasibility of using remote PA pressure monitoring in a real-world setting in Germany, The Netherlands and Ireland. After informed consent, adult patients with NYHA class III HF and a recent HF-related hospitalization are evaluated for suitability for permanent implantation of a CardioMEMS™ sensor. Participation in MEMS-HF is open to qualifying subjects regardless of left ventricular ejection fraction (LVEF). Patients with reduced ejection fraction must be on stable guideline-directed pharmacotherapy as tolerated. The study will enroll 230 patients in approximately 35 centers. Expected duration is 36 months (24-month enrolment plus ≥ 12-month follow-up). Primary endpoints are freedom from device/system-related complications and freedom from pressure sensor failure at 12-month post-implant. Secondary endpoints include the annualized rate of HF-related hospitalization at 12 months versus the rate over the 12 months preceding implant, and health-related quality of life. Endpoints will be evaluated using data obtained after each subject's 12-month visit. The MEMS-HF study will provide robust evidence on the clinical safety and feasibility of implementing haemodynamic monitoring as a novel disease management tool in routine out-patient care in selected European healthcare systems. ClinicalTrials.gov; NCT02693691.

Efficacy of spinal cord stimulators in treating peripheral neuropathy: a case series.

PubMed

Abd-Elsayed, Alaa; Schiavoni, Nick; Sachdeva, Harsh

2016-02-01

Peripheral neuropathy is a common cause of pain, and it is increasing in prevalence. Peripheral neuropathic pain is very hard to treat and can be resistant to multiple pain management modalities. Our series aimed at testing the efficacy of spinal cord stimulators (SCSs) in treating resistant painful peripheral neuropathy. Case 1: A 79-year-old man presented to our clinic with long-standing history of painful peripheral diabetic neuropathy resistant to conservative management. After failure of all possible modalities, we offered the patient an SCS trial that was very successful, and we proceeded with the permanent implant that continued to help with his pain and allowed the patient to wean down his medications. Case 2: A 60-year-old man presented with chronic peripheral neuropathy secondary to HIV, patient failed all conservative and procedural management. Patient then had an SCS trial that relieved his pain significantly. Unfortunately, we did not proceed with the implant due to deterioration of the patient general health. Case 3: A 39-year-old woman presented with painful peripheral neuropathy secondary to chemotherapy for breast cancer. After failure of medication management and procedures, patient had a SCS trial that improved her pain and we then proceeded with performing the permanent implant that controlled her pain. We presented 3 cases with chronic painful peripheral neuropathy secondary to HIV, diabetes mellitus, and chemotherapy that was resistant to conservative pain management and procedures that was successfully treated with neurostimulation. Copyright © 2016 Elsevier Inc. All rights reserved.

The Number of Recalled Leads is Highly Predictive of Lead Failure: Results From the Pacemaker and Implantable Defibrillator Leads Survival Study ("PAIDLESS").

PubMed

Kersten, Daniel J; Yi, Jinju; Feldman, Alyssa M; Brahmbhatt, Kunal; Asheld, Wilbur J; Germano, Joseph; Islam, Shahidul; Cohen, Todd J

2016-12-01

The purpose of this study was to determine if implantation of multiple recalled defibrillator leads is associated with an increased risk of lead failure. The authors of the Pacemaker and Implantable Defibrillator Leads Survival Study ("PAIDLESS") have previously reported a relationship between recalled lead status, lead failure, and patient mortality. This substudy analyzes the relationship in a smaller subset of patients who received more than one recalled lead. The specific effects of having one or more recalled leads have not been previously examined. This study analyzed lead failure and mortality of 3802 patients in PAIDLESS and compared outcomes with respect to the number of recalled leads received. PAIDLESS includes all patients at Winthrop University Hospital who underwent defibrillator lead implantation between February 1, 1996 and December 31, 2011. Patients with no recalled ICD leads, one recalled ICD lead, and two recalled ICD leads were compared using the Kaplan-Meier method and log-rank test. Sidak adjustment method was used to correct for multiple comparisons. All calculations were performed using SAS 9.4. P-values <.05 were considered statistically significant. This study included 4078 total ICD leads implanted during the trial period. There were 2400 leads (59%) in the no recalled leads category, 1620 leads (40%) in the one recalled lead category, and 58 leads (1%) in the two recalled leads category. No patient received more than two recalled leads. Of the leads categorized in the two recalled leads group, 12 experienced lead failures (21%), which was significantly higher (P<.001) than in the no recalled leads group (60 failures, 2.5%) and one recalled lead group (81 failures; 5%). Multivariable Cox's regression analysis found a total of six significant predictive variables for lead failure including the number of recalled leads (P<.001 for one and two recalled leads group). The number of recalled leads is highly predictive of lead failure. Lead-based multivariable Cox's regression analysis produced a total of six predictive variable categories for lead failure, one of which was the number of recalled leads. Kaplan-Meier analysis showed that the leads in the two recalled leads category failed faster than both the no recalled lead and one recalled lead groups. The greater the number of recalled leads to which patients are exposed, the greater the risk of lead failure.

Why do dental implants fail? Part I.

PubMed

el Askary, A S; Meffert, R M; Griffin, T

1999-01-01

Many factors are attributed to failure of the dental implant, either directly or indirectly. The focus of this article is to define the causation of dental implant failure, as well as to present an evaluation of the implant literature regarding etiology, classification, management, and treatment of implant failures. This article will highlight the initial signs of implant failure with a view of some clinical cases in terms of classification and degrees of implant failure. Finally, a dental implant failure checklist is formulated to guide the practitioner in defining the cause of implant failure, be it infective or noninfective, and to establish percentages and frequency of occurrence. The checklist applies to all implant systems and will help to determine the factors responsible for causation and the repair procedures, whether they are at the surgical or restorative phases. The definition of implant failure is set forth in terms of ailing, failing, failed, and surviving implants, and the appropriate treatments and dispositions are outlined.

Minimally Invasive Implantable Fetal Micropacemaker: Mechanical Testing and Technical Refinements

PubMed Central

Zhou, Li; Vest, Adriana N.; Peck, Raymond A.; Sredl, Jonathan P.; Huang, Xuechen; Bar-Cohen, Yaniv; Silka, Michael J.; Pruetz, Jay D.; Chmait, Ramen H.; Loeb, Gerald E.

2016-01-01

This paper discusses the technical and safety requirements for cardiac pacing of a human fetus with heart failure and hydrops fetalis secondary to complete heart block. Engineering strategies to meet specific technical requirements were integrated into a systematic design and implementation consisting of a novel fetal micropacemaker, a percutaneous implantation system, and a sterile package that enables device storage and recharging maintenance in a clinical setting. We further analyzed observed problems on myocardial fixation and pacing lead fatigue previously reported in earlier preclinical trials. This paper describes the technical refinements of the implantable fetal micropacemaker to overcome these challenges. The mechanical performance has been extensively tested to verify the improvement of reliability and safety margins of the implantation system. PMID:27021067

Vertical augmentation with interpositional blocks of anorganic bovine bone vs. 7-mm-long implants in posterior mandibles: 1-year results of a randomized clinical trial.

PubMed

Felice, Pietro; Pellegrino, Gerardo; Checchi, Luigi; Pistilli, Roberto; Esposito, Marco

2010-12-01

To evaluate whether 7-mm-long implants could be an alternative to longer implants placed in vertically augmented posterior mandibles. Sixty patients with posterior mandibular edentulism with 7-8 mm bone height above the mandibular canal were randomized to either vertical augmentation with anorganic bovine bone blocks and delayed 5-month placement of ≥10 mm implants or to receive 7-mm-long implants. Four months after implant placement, provisional prostheses were delivered, replaced after 4 months, by definitive prostheses. The outcome measures were prosthesis and implant failures, any complications and peri-implant marginal bone levels. All patients were followed to 1 year after loading. One patient dropped out from the short implant group. In two augmented mandibles, there was not sufficient bone to place 10-mm-long implants possibly because the blocks had broken apart during insertion. One prosthesis could not be placed when planned in the 7 mm group vs. three prostheses in the augmented group, because of early failure of one implant in each patient. Four complications (wound dehiscence) occurred during graft healing in the augmented group vs. none in the 7 mm group. No complications occurred after implant placement. These differences were not statistically significant. One year after loading, patients of both groups lost an average of 1 mm of peri-implant bone. There no statistically significant differences in bone loss between groups. When residual bone height over the mandibular canal is between 7 and 8 mm, 7 mm short implants might be a preferable choice than vertical augmentation, reducing the chair time, expenses and morbidity. These 1-year preliminary results need to be confirmed by follow-up of at least 5 years. © 2010 John Wiley & Sons A/S.

Evaluation of possible prognostic factors for the success, survival, and failure of dental implants.

PubMed

Geckili, Onur; Bilhan, Hakan; Geckili, Esma; Cilingir, Altug; Mumcu, Emre; Bural, Canan

2014-02-01

To analyze the prognostic factors that are associated with the success, survival, and failure rates of dental implants. Data including implant sizes, insertion time, implant location, and prosthetic treatment of 1656 implants have been collected, and the association of these factors with success, survival, and failure of implants was analyzed. The success rate was lower for short and maxillary implants. The failure rate of maxillary implants exceeded that of mandibular implants, and the failure rate of implants that were placed in the maxillary anterior region was significantly higher than other regions. The failure rates of implants that were placed 5 years ago or more were higher than those that were placed later. Anterior maxilla is more critical for implant loss than other sites. Implants in the anterior mandible show better success compared with other locations, and longer implants show better success rates. The learning curve of the clinician influences survival and success rates of dental implants.

Analysis of risk factors for cluster behavior of dental implant failures.

PubMed

Chrcanovic, Bruno Ramos; Kisch, Jenö; Albrektsson, Tomas; Wennerberg, Ann

2017-08-01

Some studies indicated that implant failures are commonly concentrated in few patients. To identify and analyze cluster behavior of dental implant failures among subjects of a retrospective study. This retrospective study included patients receiving at least three implants only. Patients presenting at least three implant failures were classified as presenting a cluster behavior. Univariate and multivariate logistic regression models and generalized estimating equations analysis evaluated the effect of explanatory variables on the cluster behavior. There were 1406 patients with three or more implants (8337 implants, 592 failures). Sixty-seven (4.77%) patients presented cluster behavior, with 56.8% of all implant failures. The intake of antidepressants and bruxism were identified as potential negative factors exerting a statistically significant influence on a cluster behavior at the patient-level. The negative factors at the implant-level were turned implants, short implants, poor bone quality, age of the patient, the intake of medicaments to reduce the acid gastric production, smoking, and bruxism. A cluster pattern among patients with implant failure is highly probable. Factors of interest as predictors for implant failures could be a number of systemic and local factors, although a direct causal relationship cannot be ascertained. © 2017 Wiley Periodicals, Inc.

Failure rates of mini-implants placed in the infrazygomatic region.

PubMed

Uribe, Flavio; Mehr, Rana; Mathur, Ajay; Janakiraman, Nandakumar; Allareddy, Veerasathpurush

2015-01-01

The purpose of this pilot study was to evaluate the failure rates of mini-implants placed in the infrazygomatic region and to evaluate factors that affect their stability. A retrospective cohort study of 30 consecutive patients (55 mini-implants) who had infrazygomatic mini-implants at a University Clinic were evaluated for failure rates. Patient, mini-implant, orthodontic, surgical, and mini-implant maintenance factors were evaluated by univariate logistic regression models for association to failure rates. A 21.8 % failure rate of mini-implants placed in the infazygomatic region was observed. None of the predictor variables were significantly associated with higher or lower odds for failed implants. Failure rates for infrazygomatic mini-implants were slightly higher than those reported in other maxilla-mandibular osseous locations. No predictor variables were found to be associated to the failure rates.

Basic concepts in metal work failure after metastatic spine tumour surgery.

PubMed

Kumar, Naresh; Patel, Ravish; Wadhwa, Anshuja Charvi; Kumar, Aravind; Milavec, Helena Maria; Sonawane, Dhiraj; Singh, Gurpal; Benneker, Lorin Michael

2018-04-01

The development of spinal implants marks a watershed in the evolution of metastatic spine tumour surgery (MSTS), which has evolved from standalone decompressive laminectomy to instrumented stabilization and decompression with reconstruction when necessary. Fusion may not be feasible after MSTS due to poor quality of graft host bed along with adjunct chemotherapy and/or radiotherapy postoperatively. With an increase in the survival of patients with spinal tumours, there is a probability of an increase in the rate of implant failure. This review aims to help establish a clear understanding of implants/constructs used in MSTS and to highlight the fundamental biomechanics of implant/construct failures. Published literature on implant failure after spine surgery and MSTS has been reviewed. The evolution of spinal implants and their role in MSTS has been briefly described. The review defines implant/construct failures using radiological parameters that are practical, feasible, and derived from historical descriptions. We have discussed common modes of implant/construct failure after MSTS to allow further understanding, interception, and prevention of catastrophic failure. Implant failure rates in MSTS are in the range of 2-8%. Variability in patterns of failure has been observed based on anatomical region and the type of constructs used. Patients with construct/implant failures may or may not be symptomatic and present either as early (< 3months) or late failures (> 3months). It has been noted that not all the implant failures after MSTS result in revisions. Based on the observed radiological criteria and clinical presentations, we have proposed a clinico-radiological classification for implant/construct failure after MSTS.

A noninterventional study documenting use and success of implants with a new chemically modified titanium surface in daily dental practice.

PubMed

Luongo, Giuseppe; Oteri, Giacomo

2010-01-01

A new chemically modified titanium surface, SLActive, has recently been developed. The results obtained in controlled clinical trials indicate that this implant can be safely used and that it offers predictable results. The goal of this noninterventional study was to verify that the success rates of implants used in daily dental practice are comparable to those reported in controlled clinical trials. This study was a prospective, noninterventional study using implants with a chemically modified surface according to the daily dental practice procedures applied by private practitioners. The choice of the implantation procedure and the loading protocol were the responsibility of the investigator and were chosen according to the patient's needs. Thirty clinical centers actively participated in this study, and 226 patients were treated, of which, 8 patients were lost to follow-up. Because of the noninterventional design of the study, the patients were not selected according to strictly defined inclusion/exclusion criteria. Thus, the study included individuals with risk factors such as smoking (24%), untreated gingivitis or periodontitis (9%), and bruxism (6%). The implants were equally distributed between mandible (46%) and maxilla (54%). A bone augmentation procedure was done in 31% of the cases. Early loading (functional loading between 48 hours and 3 months after implant insertion) was applied most frequently (48%), followed by the conventional loading protocol (3 to 6 months after implant placement, 34%). Immediate restoration and immediate loading were rare (7% and 2%, respectively). Of 276 implants inserted and documented, 5 implants failures were reported, all of which were associated with a sinus floor augmentation procedure. The survival rate was 98.2% at the 1-year follow-up visit. The results showed that implants with a chemically modified surface can be successfully restored with success rates similar to those reported in formal clinical trials under more controlled conditions.

Immediate versus early loading of two implants placed with a flapless technique supporting mandibular bar-retained overdentures: a single-blinded, randomised controlled clinical trial.

PubMed

Cannizzaro, Gioacchino; Leone, Michele; Esposito, Marco

2008-01-01

To evaluate the efficacy of immediate loading versus early loading at 6 weeks of bar-retained mandibular overdentures supported by two implants placed with a flapless technique. Sixty patients were randomised: 30 to the immediately loaded group and 30 to the early loaded group. To be immediately loaded, implants had to be inserted with a minimum torque > 48 Ncm. Outcome measures were prosthesis and implant failures, biological and biomechanical complications, patient satisfaction, and Implant Stability Quotient (ISQ) assessed with a resonance frequency analysis instrument. Sixty implants were placed in each group. Flaps had to be raised in nine patients to check drill direction or to better visualise the area after multiple teeth extraction. Two implants in two patients did not reach the planned insertion torque and were immediately replaced by larger diameters ones. After 1 year no drop out occurred and two early loaded implants failed in two patients. There were no statistically significant differences between groups for prosthesis failures, implant losses, complications, and mean ISQ values; however, patients in the immediately loaded group were significantly more satisfied than those loaded early. When comparing mean ISQ values taken 6 weeks after placement with 1-year data within each group, values decreased significantly. Mandibular overdentures can be successfully loaded the same day of implant placement with a minimally invasive surgery, increasing patient satisfaction while decreasing treatment time and patient discomfort. No apparent advantages were seen when loading the overdentures at 6 weeks.

Rehabilitation of postrior atrophic edentulous jaws: prostheses supported by 5 mm short implants or by longer implants in augmented bone? One-year results from a pilot randomised clinical trial.

PubMed

Esposito, Marco; Pellegrino, Gerardo; Pistilli, Roberto; Felice, Pietro

2011-01-01

To evaluate whether 5 mm short dental implants could be an alternative to augmentation with anorganic bovine bone and placement of at least 10 mm long implants in posterior atrophic jaws. Fifteen patients with bilateral atrophic mandibles (5-7 mm bone height above the mandibular canal), and 15 patients with bilateral atrophic maxillae (4-6 mm bone height below the maxillary sinus) and bone thickness of at least 8 mm, were randomised according to a splitmouth design to receive one to three 5 mm short implants or at least 10 mm long implants in augmented bone. Mandibles were vertically augmented with interpositional bone blocks and maxillary sinuses with particulated bone via a lateral window. Implants were placed after 4 months, submerged and loaded, after 4 months, with provisional prostheses. Four months later, definitive provisionally cemented prostheses were delivered. Outcome measures were: prosthesis and implant failures, any complication and peri-implant marginal bone level changes. In 5 augmented mandibles, the planned 10 mm long implants could not be placed and shorter implants (7 and 8.5 mm) had to be used instead. One year after loading no patient dropped out. Two long (8.5 mm in the mandible and 13 mm in the maxilla) implants and one 5 mm short maxillary implant failed. There were no statistically significant differences in failures or complications. Patients with short implants lost on average 1 mm of peri-implant bone and patients with longer implants lost 1.2 mm. This difference was statistically significant. This pilot study suggests that 1 year after loading, 5 mm short implants achieve similar if not better results than longer implants placed in augmented bone. Short implants might be a preferable choice to bone augmentation since the treatment is faster, cheaper and associated with less morbidity, however their long-term prognosis is unknown.

Risk factors for implant failure: a retrospective study in an educational institution using GEE analyses.

PubMed

Borba, Marcelo; Deluiz, Daniel; Lourenço, Eduardo José Veras; Oliveira, Luciano; Tannure, Patrícia Nivoloni

2017-08-21

This study aimed to evaluate dental implant outcomes and to identify risk factors associated with implant failure over 12 years via dental records of patients attending an educational institution. Dental records of 202 patients receiving 774 dental implants from 2002 to 2014 were analyzed by adopting a more reliable statistical method to evaluate risk factors with patients as the unit [generalized estimating equation (GEE)]. Information regarding patient age at implantation, sex, use of tobacco, and history of systemic diseases was collected. Information about implant location in the arch region and implant length, diameter, and placement in a grafted area was evaluated after 2 years under load. Systemic and local risk factors for early and late implant failure were studied. A total of 18 patients experienced 25 implant failures, resulting in an overall survival rate of 96.8% (2.84% and 0.38% early and late implant failures, respectively). The patient-based survival rate was 91.8%. GEE univariate and multivariate analyses revealed that a significant risk factor for implant failure was the maxillary implant (p = 0.006 and p = 0.014, respectively). Bone grafting appeared to be a risk factor for implant failure (p = 0.054). According to GEE analyses, maxillary implants had significantly worse outcomes in this population and were considered to be a risk factor for implant failure. Our results suggested that implants placed in a bone augmentation area had a tendency to fail.

Declining Risk of Sudden Death in Heart Failure.

PubMed

Shen, Li; Jhund, Pardeep S; Petrie, Mark C; Claggett, Brian L; Barlera, Simona; Cleland, John G F; Dargie, Henry J; Granger, Christopher B; Kjekshus, John; Køber, Lars; Latini, Roberto; Maggioni, Aldo P; Packer, Milton; Pitt, Bertram; Solomon, Scott D; Swedberg, Karl; Tavazzi, Luigi; Wikstrand, John; Zannad, Faiez; Zile, Michael R; McMurray, John J V

2017-07-06

The risk of sudden death has changed over time among patients with symptomatic heart failure and reduced ejection fraction with the sequential introduction of medications including angiotensin-converting-enzyme inhibitors, angiotensin-receptor blockers, beta-blockers, and mineralocorticoid-receptor antagonists. We sought to examine this trend in detail. We analyzed data from 40,195 patients who had heart failure with reduced ejection fraction and were enrolled in any of 12 clinical trials spanning the period from 1995 through 2014. Patients who had an implantable cardioverter-defibrillator at the time of trial enrollment were excluded. Weighted multivariable regression was used to examine trends in rates of sudden death over time. Adjusted hazard ratios for sudden death in each trial group were calculated with the use of Cox regression models. The cumulative incidence rates of sudden death were assessed at different time points after randomization and according to the length of time between the diagnosis of heart failure and randomization. Sudden death was reported in 3583 patients. Such patients were older and were more often male, with an ischemic cause of heart failure and worse cardiac function, than those in whom sudden death did not occur. There was a 44% decline in the rate of sudden death across the trials (P=0.03). The cumulative incidence of sudden death at 90 days after randomization was 2.4% in the earliest trial and 1.0% in the most recent trial. The rate of sudden death was not higher among patients with a recent diagnosis of heart failure than among those with a longer-standing diagnosis. Rates of sudden death declined substantially over time among ambulatory patients with heart failure with reduced ejection fraction who were enrolled in clinical trials, a finding that is consistent with a cumulative benefit of evidence-based medications on this cause of death. (Funded by the China Scholarship Council and the University of Glasgow.).

Clinical evaluation of a novel dental implant system as single implants under immediate loading conditions - 4-month post-loading results from a multicentre randomised controlled trial.

PubMed

Esposito, Marco; Trullenque-Eriksson, Anna; Blasone, Rodolfo; Malaguti, Giuliano; Gaffuri, Cristiano; Caneva, Marco; Minciarelli, Armando; Luongo, Giuseppe

To evaluate the safety and clinical effectiveness of a novel dental implant system (GENESIS Implant System, Keystone Dental, Massachusetts, USA) using another dental implant system by the same manufacturer as a control (PRIMA Implant System, Keystone Dental). A total of 53 patients requiring at least two single crowns had their sites randomised according to a split-mouth design to receive both implant systems at six centres. If implants could be placed with a torque superior to 40 Ncm they were to be loaded immediately with provisional crowns, otherwise after 3 months of submerged healing. Provisional crowns were replaced by definitive crowns 4 months after initial loading, when the follow-up period for the initial part of this study was completed. Outcome measures were crown/implant failures, complications, pink esthetic score (PES), peri-implant marginal bone level changes, plaque score, marginal bleeding, patients and preference of the clinician. In total 53 PRIMA and 53 GENESIS implants were placed. Three patients dropped out but all of the remaining patients were followed up to 4-months post-loading. No PRIMA implant failed whereas four GENESIS implants failed. Only two complications were reported for PRIMA implants. There were no statistically significant differences for crown/implant failures (difference in proportions = 0.080; P (McNemar test) = 0.125) and complications (difference in proportions = -0.04; P (McNemar test) = 0.500) between the implant systems. There were no differences at 4-months post-loading for plaque (difference = -0.54, 95% CI: -3.01 to 1.93; P (Paired t-test) = 0.660), marginal bleeding (difference = -3.8, 95% CI: -7.63 to 0.019; P (Paired t-test) = 0.051), PES (difference = 0.47, 95% CI: -0.56 to 1.50; P (Paired t-test) = 0.365) and marginal bone level changes (difference in mm = -0.04, 95% CI: -0.33 to 0.26; P (Paired t-test) = 0.795). The majority of the patients (46) had no preference regarding the two implant systems evaluated. Three operators preferred GENESIS implants, two had no preference and one preferred GENESIS in medium and soft bone and PRIMA in hard bone. No statistically significant differences were observed between the systems' implant types, although four GENESIS implants failed versus none of the PRIMA type. Longer follow-ups of wider patient populations are needed to better understand whether there is an effective advantage with one of the two implant designs. Conflict-of-interest statement: This research project was originally funded by Keystone Italia, Dental spa (Verona, Italy), the manufacturer of the implants evaluated in this investigation. 
 
However, when Keystone Italia received the data of the present manuscript, they refused to honour the financial agreement for the present publication. Therefore, no further follow-ups of this trial will be considered. A legal action was initiated against Keystone Italia. The data belonged to the authors and by no means was the manufacturer allowed to interfere with the conduct of the trial or the publication of the results.

Application of implantable hemodynamic monitoring in the management of patients with diastolic heart failure: a subgroup analysis of the COMPASS-HF trial.

PubMed

Zile, Michael R; Bourge, Robert C; Bennett, Tom D; Stevenson, Lynne Warner; Cho, Yong K; Adamson, Philip B; Aaron, Mark F; Aranda, Juan M; Abraham, William T; Smart, Frank W; Kueffer, Fred J

2008-12-01

Nearly half of all patients with chronic heart failure (HF) have a normal ejection fraction (EF), and abnormal diastolic function (ie, diastolic heart failure [DHF]). However, appropriate management of DHF patients remains a difficult and uncertain challenge. The Chronicle Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure (COMPASS-HF) trial was designed to evaluate whether an implantable hemodynamic monitor (IHM) was safe and effective in reducing the number of heart failure-related events (HFRE) in patients with chronic HF. The current study presents data on a prespecified and planned subgroup analysis from the COMPASS-HF trial: 70 patients with an EF > or =50% (ie, DHF). As such, this represents a subgroup analysis of the COMPASS-HF Trial. DHF patients were randomized to IHM-guided care (treatment) vs. standard care (control) for 6 months. All 70 patients received optimal medical therapy, but the hemodynamic information from the IHM was used to guide patient management only in the treatment group. The HFRE rate in DHF patients randomized to treatment was 0.58 events/6 months compared with DHF patients randomized to control, which was 0.73 events/6 months; this represented a 20% nonsignificant reduction in the overall HFRE rate in the treatment group (95% CI = -46, 56, P = .66). There was a 29% nonsignificant reduction in the relative risk of a HF hospitalization in the DHF patients randomized to treatment compared with DHF patients randomized to control (95% CI = -69, 70, P = .43). The IHM was shown to be safe and was associated with a very low system-related and procedure-related complication rate in DHF patients. However, in this subgroup analysis limited to 70 DHF patients, the addition IHM-guided care did not significantly lower the rate of HFR events. The results of this subgroup analysis in DHF patients, for whom there are currently no proven, effective management strategies, will be used to design future studies defining the effects of IHM-guided care in patients with DHF.

Load fatigue performance of four implant-abutment interface designs: effect of torque level and implant system.

PubMed

Quek, H C; Tan, Keson B; Nicholls, Jack I

2008-01-01

Biomechanical load-fatigue performance data on single-tooth implant systems with different implant-abutment interface designs is lacking in the literature. This study evaluated the load fatigue performance of 4 implant-abutment interface designs (Brånemark-CeraOne; 3i Osseotite-STA abutment; Replace Select-Easy abutment; and Lifecore Stage-1-COC abutment system). The number of load cycles to fatigue failure of 4 implant-abutment designs was tested with a custom rotational load fatigue machine. The effect of increasing and decreasing the tightening torque by 20% respectively on the load fatigue performance was also investigated. Three different tightening torque levels (recommended torque, -20% recommended torque, +20% recommended torque) were applied to the 4 implant systems. There were 12 test groups with 5 samples in each group. The rotational load fatigue machine subjected specimens to a sinusoidally applied 35 Ncm bending moment at a test frequency of 14 Hz. The number of cycles to failure was recorded. A cutoff of 5 x 10(6) cycles was applied as an upper limit. There were 2 implant failures and 1 abutment screw failure in the Brånemark group. Five abutment screw failures and 4 implant failures was recorded for the 3i system. The Replace Select system had 1 implant failure. Five cone screw failures were noted for the Lifecore system. Analysis of variance revealed no statistically significant difference in load cycles to failure for the 4 different implant-abutment systems torqued at recommended torque level. A statistically significant difference was found between the -20% torque group and the +20% torque group (P < .05) for the 3i system. Load fatigue performance and failure location is system specific and related to the design characteristics of the implant-abutment combination. It appeared that if the implant-abutment interface was maintained, load fatigue failure would occur at the weakest point of the implant. It is important to use the torque level recommended by the manufacturer.

Endometrial scratching in women with implantation failure after a first IVF/ICSI cycle; does it lead to a higher live birth rate? The SCRaTCH study: a randomized controlled trial (NTR 5342).

PubMed

van Hoogenhuijze, N E; Torrance, H L; Mol, F; Laven, J S E; Scheenjes, E; Traas, M A F; Janssen, C; Cohlen, B; Teklenburg, G; de Bruin, J P; van Oppenraaij, R; Maas, J W M; Moll, E; Fleischer, K; van Hooff, M H; de Koning, C; Cantineau, A; Lambalk, C B; Verberg, M; Nijs, M; Manger, A P; van Rumste, M; van der Voet, L F; Preys-Bosman, A; Visser, J; Brinkhuis, E; den Hartog, J E; Sluijmer, A; Jansen, F W; Hermes, W; Bandell, M L; Pelinck, M J; van Disseldorp, J; van Wely, M; Smeenk, J; Pieterse, Q D; Boxmeer, J C; Groenewoud, E R; Eijkemans, M J C; Kasius, J C; Broekmans, F J M

2017-07-21

Success rates of assisted reproductive techniques (ART) are approximately 30%, with the most important limiting factor being embryo implantation. Mechanical endometrial injury, also called 'scratching', has been proposed to positively affect the chance of implantation after embryo transfer, but the currently available evidence is not yet conclusive. The primary aim of this study is to determine the effect of endometrial scratching prior to a second fresh in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) cycle on live birth rates in women with a failed first IVF/ICSI cycle. Multicenter randomized controlled trial in Dutch academic and non-academic hospitals. A total of 900 women will be included of whom half will undergo an endometrial scratch in the luteal phase of the cycle prior to controlled ovarian hyperstimulation using an endometrial biopsy catheter. The primary endpoint is the live birth rate after the 2 nd fresh IVF/ICSI cycle. Secondary endpoints are costs, cumulative live birth rate (after the full 2 nd IVF/ICSI cycle and over 12 months of follow-up); clinical and ongoing pregnancy rate; multiple pregnancy rate; miscarriage rate and endometrial tissue parameters associated with implantation failure. Multiple studies have been performed to investigate the effect of endometrial scratching on live birth rates in women undergoing IVF/ICSI cycles. Due to heterogeneity in both the method and population being scratched, it remains unclear which group of women will benefit from the procedure. The SCRaTCH trial proposed here aims to investigate the effect of endometrial scratching prior to controlled ovarian hyperstimulation in a large group of women undergoing a second IVF/ICSI cycle. NTR 5342 , registered July 31 st , 2015. Version 4.10, January 4th, 2017.

Prosthodontic maintenance of overdentures on zirconia implants: 1-year results of a randomized controlled trial.

PubMed

Osman, Reham B; Ma, Sunyoung

2014-01-01

The purpose of this study was to determine the prosthodontic outcomes of one-piece zirconia implants and their attachment systems in edentulous participants with maxillary and mandibular overdentures after 1 year of a randomized controlled trial. Random allocation of 24 edentulous participants (age range: 45 to 86 years) into titanium (control) or zirconia (test) groups using onepiece implants and a planned unsplinted prosthodontic design was performed. Four maxillary implants (one midpalatal; three anterior crestal) and three mandibular implants (one midsymphyseal; two bilateral distal) were conventionally loaded with the overdentures. Similar attachment systems were used throughout: ball abutment-type patrices (diameter: 2.25 to 3.1 mm as part of the one-piece implants) and custommade plastic matrices (with or without metal housings depending on the patrix size). Prosthodontic outcomes were documented during the first year of the clinical trial. Following three deaths and two dropouts, there were 19 participants who were available at the 1-year recall. Of these participants, 3 had early maxillary implant failure and had to be converted to conventional maxillary complete dentures opposing mandibular implant overdentures. There were 79 maintenance events, 34 in the titanium (control) group and 45 in the zirconia (test) group. Patrix loss occurred as a result of three zirconia implant fractures (one mandibular and two crestal maxillary implants). Maintenance events were principally the replacement of matrices and overdenture fracture. Although relines and replacement overdentures also occurred, overall there were no significant differences in prosthodontic maintenance between the control and test groups. A six-field prosthodontic-success analysis table showed no statistically significant difference between the two groups; however, 50% of participants in each group were allocated to the retreatment (repair) field, which produced a low prosthodontic success rate. Removable overdentures can be used on both one-piece titanium and zirconia implants with these attachment systems, due to no difference in prosthodontic maintenance and success. Before recommending routine use of a "metal-free" overdenture treatment option in clinical practice, consideration must be given to the success of the implants themselves.

Bruxism and dental implant failures: a multilevel mixed effects parametric survival analysis approach.

PubMed

Chrcanovic, B R; Kisch, J; Albrektsson, T; Wennerberg, A

2016-11-01

Recent studies have suggested that the insertion of dental implants in patients being diagnosed with bruxism negatively affected the implant failure rates. The aim of the present study was to investigate the association between the bruxism and the risk of dental implant failure. This retrospective study is based on 2670 patients who received 10 096 implants at one specialist clinic. Implant- and patient-related data were collected. Descriptive statistics were used to describe the patients and implants. Multilevel mixed effects parametric survival analysis was used to test the association between bruxism and risk of implant failure adjusting for several potential confounders. Criteria from a recent international consensus (Lobbezoo et al., J Oral Rehabil, 40, 2013, 2) and from the International Classification of Sleep Disorders (International classification of sleep disorders, revised: diagnostic and coding manual, American Academy of Sleep Medicine, Chicago, 2014) were used to define and diagnose the condition. The number of implants with information available for all variables totalled 3549, placed in 994 patients, with 179 implants reported as failures. The implant failure rates were 13·0% (24/185) for bruxers and 4·6% (155/3364) for non-bruxers (P < 0·001). The statistical model showed that bruxism was a statistically significantly risk factor to implant failure (HR 3·396; 95% CI 1·314, 8·777; P = 0·012), as well as implant length, implant diameter, implant surface, bone quantity D in relation to quantity A, bone quality 4 in relation to quality 1 (Lekholm and Zarb classification), smoking and the intake of proton pump inhibitors. It is suggested that the bruxism may be associated with an increased risk of dental implant failure. © 2016 John Wiley & Sons Ltd.

Interventions for replacing missing teeth: management of soft tissues for dental implants.

PubMed

Esposito, Marco; Maghaireh, Hassan; Grusovin, Maria Gabriella; Ziounas, Ioannis; Worthington, Helen V

2012-02-15

Dental implants are usually placed by elevating a soft tissue flap, but in some instances, they can also be placed flapless reducing patient discomfort. Several flap designs and suturing techniques have been proposed. Soft tissues are often manipulated and augmented for aesthetic reasons. It is often recommended that implants are surrounded by a sufficient width of attached/keratinised mucosa to improve their long-term prognosis. To evaluate whether (1a) flapless procedures are beneficial for patients, and (1b) which is the ideal flap design; whether (2a) soft tissue correction/augmentation techniques are beneficial for patients, and (2b) which are the best techniques; whether (3a) techniques to increase the peri-implant keratinised mucosa are beneficial for patients, and (3b) which are the best techniques; and (4) which are the best suturing techniques/materials. The following electronic databases were searched: the Cochrane Oral Health Group Trials Register (to 9 June 2011), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 2), MEDLINE via OVID (1950 to 9 June 2011), EMBASE via OVID (1980 to 9 June 2011). Several dental journals were handsearched. There were no language restrictions. All randomised controlled trials (RCTs) of root-form osseointegrated dental implants, with a follow-up of at least 6 months after function, comparing various techniques to handle soft tissues in relation to dental implants. Outcome measures, according to the different hypotheses, were: prosthetic and implant failures, biological complications, aesthetics evaluated by patients and dentists, postoperative pain, marginal peri-implant bone level changes on periapical radiographs, patient preference, ease of maintenance by patient, soft tissue thickness changes and attached/keratinised mucosa height changes. Screening of eligible studies, assessment of the methodological quality of the trials and data extraction were conducted at least in duplicate and independently by two or more review authors. Trial authors were contacted for missing information. Results were expressed using risk ratios for dichotomous outcomes and mean differences for continuous outcomes with 95% confidence intervals. Seventeen potentially eligible RCTs were identified but only six trials with 138 patients in total could be included. One study was at low risk of bias, two studies were judged to be at unclear risk of bias and three at high risk of bias. Two trials (56 patients) compared flapless placement of dental implants with conventional flap elevation, one trial (10 patients) compared crestal versus vestibular incisions, one trial (20 patients) Erbium:YAG laser versus flap elevation at the second-stage surgery for implant exposure, one split-mouth trial (10 patients) evaluated whether connective tissue graft at implant placement could be effective in augmenting peri-implant tissues, and one trial (40 patients) compared autograft with an animal-derived collagen matrix to increase the height of the keratinised mucosa. On a patient, rather than per implant basis, implants placed with a flapless technique and implant exposures performed with laser induced statistically significantly less postoperative pain than flap elevation. Sites augmented with soft tissues connective grafts showed a better aesthetic and thicker tissues. Both palatal autografts or the use of a porcine-derived collagen matrix are effective in increasing the height of keratinised mucosa at the price of a 0.5 mm recession of peri-implant soft tissues. There were no other statistically significant differences for any of the remaining analyses. There is limited weak evidence suggesting that flapless implant placement is feasible and has been shown to reduce patient postoperative discomfort in adequately selected patients, that augmentation at implant sites with soft tissue grafts is effective in increasing soft tissue thickness improving aesthetics and that one technique to increase the height of keratinised mucosa using autografts or an animal-derived collagen matrix was able to achieve its goal but at the price of a worsened aesthetic outcome (0.5 mm of recession). There is insufficient reliable evidence to provide recommendations on which is the ideal flap design, the best soft tissue augmentation technique, whether techniques to increase the width of keratinised/attached mucosa are beneficial to patients or not, and which are the best incision/suture techniques/materials. Properly designed and conducted RCTs, with at least 6 months of follow-up, are needed to provide reliable answers to these questions.

Incidence and Determinants of Dental Implant Failure: A Review of Electronic Health Records in a U.S. Dental School.

PubMed

Hickin, Matthew Parker; Shariff, Jaffer A; Jennette, Philip J; Finkelstein, Joseph; Papapanou, Panos N

2017-10-01

The aim of this study was to use electronic health care records (EHRs) to examine retrospectively the incidence of and attributes associated with dental implant failures necessitating implant removal in a large cohort of patients treated in the student clinics of a U.S. dental school over three and a half years. EHRs were searched for all patients who received dental implants between July 1, 2011, and December 31, 2014. Characteristics of patients and implants that were actively removed due to irrevocable failure of any etiology ("failure cohort") during this period were compared to those of all other patients who received dental implants during the same time frame ("reference cohort"). Differences in the frequency distribution of various characteristics between the failure and reference cohorts were compared. Of a total 6,129 implants placed in 2,127 patients during the study period, 179 implants (2.9%) in 120 patients (5.6%) were removed. In the multivariate analysis, presence of a removable (OR=2.86) or fixed temporary prosthesis (OR=3.71) was statistically significantly associated with increased risk for implant failure. In contrast, antibiotic coverage (pre- and post-surgery OR=0.16; post-surgery only OR=0.38) and implants of certain manufacturers were associated with lower risk of implant failure. In this sizeable cohort of patients receiving care in dental student clinics, the review of EHRs facilitated identification of multiple variables associated with implant failure resulting in removal; however, these findings do not suggest causative relationships. The adopted analytical approach can enhance quality assurance measures and may contribute to the identification of true risk factors for dental implant failure.

Elements of implant-supported rehabilitation planning in patients with bruxism.

PubMed

Sarmento, Hugo Ramalho; Dantas, Raquel Venâncio Fernandes; Pereira-Cenci, Tatiana; Faot, Fernanda

2012-11-01

The rehabilitation of partial or completely edentulous patients with implant-supported prostheses has been widely used, achieving high success rates. However, many studies consider the presence of bruxism as a contraindication for this treatment modality. The purpose of this study was to revise the literature and identify risk factors in implant-supported rehabilitation planning in subjects with bruxism. Available literature was searched through Medline, with no time limit, including only studies in English. Topics discussed were etiology of bruxism and its implications on dental implants, biomechanical considerations regarding the overload on dental implants, and methods to prevent the occurrence of overloads in implant-supported prostheses. The rehabilitation of bruxers using implant-supported prostheses, using implants with adequate length and diameter, as well as proper positioning seems to be a reliable treatment, with reduced risks of failure. Bruxism control through the use of a nightguard by rigid occlusal stabilization appliance relieved in the region of implants is highly indicated. Although it is clear that implant-supported rehabilitation of patients with bruxism requires adequate planning and follow-up, well-designed randomized controlled trials are needed to provide reliable evidence on the long-term success of this treatment modality.

Are Multidimensional Pain Inventory Coping Strategy Profiles Associated with Long-Term Spinal Cord Stimulation Effectiveness?

PubMed

Paroli, Mery; Bernini, Olivia; De Carolis, Giuliano; Tollapi, Lara; Bondi, Franca; Martini, Antonella; Dario, Alessandro; Paolicchi, Adriana

2018-05-01

It is acknowledged that the way patients cope with pain may influence treatment outcome. In particular, psychological factors are deemed important when considering patients for suitability for spinal cord stimulation (SCS). The aim of the study is to observe how pre-implantation psychological characteristics impact the effectiveness of SCS for chronic pain. The analysis comprised data from 137 patients who underwent an SCS implant. Screening evaluation included a coping strategies profile (Multidimensional Pain Inventory) and psychiatric disorders (Mini-International Neuropsychiatric Interview). Based on SCS implant outcome collected during follow-up visits, patients were divided into three groups: subjects with long-term pain relief (long-term group), subjects who failed the SCS treatment and decided to explant trial device (trial explanter group [TE]), and those who chose a permanent device (permanent explanter group [PE]). Results showed that most of the patients who failed with the SCS (TE and PE groups) demonstrated a dysfunctional coping profile and showed a higher presence of psychiatric disorders, which significantly influenced the experience and perception of pain. The findings of this study support the value of a multidisciplinary screening. Addressing psychological issues before SCS implantation can reduce the failure rate of SCS.

The Post-Myocardial Infarction Pacing Remodeling Prevention Therapy (PRomPT) Trial: Design and Rationale.

PubMed

Chung, Eugene S; Fischer, Trent M; Kueffer, Fred; Anand, Inder S; Bax, Jeroen J; Gold, Michael R; Gorman, Robert C; Theres, Heinz; Udelson, James E; Stancak, Branislav; Svendsen, Jesper H; Stone, Gregg W; Leon, Angel

2015-07-01

Despite considerable improvements in the medical management of patients with myocardial infarction (MI), patients with large MI still have substantial risk of developing heart failure. In the early post-MI setting, implantable cardioverter defibrillators have reduced arrhythmic deaths but have no impact on overall mortality. Therefore, additional interventions are required to further reduce the overall morbidity and mortality of patients with large MI. The Pacing Remodeling Prevention Therapy (PRomPT) trial is designed to study the effects of peri-infarct pacing in preventing adverse post-MI remodeling. Up to 120 subjects with peak creatine phosphokinase >3,000 U/L (or troponin T >10 μg/L) at time of MI will be randomized to either dual-site or single-site biventricular pacing with the left ventricular lead implanted in a peri-infarct region or to a nonimplanted control group. Those randomized to a device will be blinded to the pacing mode, but randomization to a device or control cannot be blinded. Subjects randomized to pacing will have the device implanted within 10 days of MI. The primary objective is to assess the change in left ventricular end-diastolic volume from baseline to 18 months. Secondary objectives are to assess changes in clinical and mechanistic parameters between the groups, including rates of hospitalization for heart failure and cardiovascular events, the incidence of sudden cardiac death and all-cause mortality, New York Heart Association functional class, 6-minute walking distance, and quality of life. The PRomPT trial will provide important evidence regarding the potential of peri-infarct pacing to interrupt adverse remodeling in patients with large MI. Copyright © 2015 Elsevier Inc. All rights reserved.

Reamed versus unreamed intramedullary nailing for the treatment of femoral fractures

PubMed Central

Li, A-Bing; Zhang, Wei-Jiang; Guo, Wei-Jun; Wang, Xin-Hua; Jin, Hai-Ming; Zhao, You-Ming

2016-01-01

Abstract Background and objective: Intramedullary nailing is commonly used for treating femoral shaft fractures, one of the most common long bone fractures in adults. The reamed intramedullary nail is considered the standard implant for femoral fractures. This meta-analysis was performed to verify the superiority of reamed intramedullary nailing over unreamed intramedullary nailing in fractures of the femoral shaft in adults. Subgroup analysis of implant failure and secondary procedure was also performed. Methods: Electronic literature databases were used to identify relevant publications and included MEDLINE (Ovid interface), EMBASE (Ovid interface), and the Cochrane Central Register of Controlled Trials (CENTRAL; Wiley Online Library). The versions available on January 30, 2016, were utilized. Only human studies, which were designed as randomized controlled clinical trials, were included. Two authors independently evaluated the quality of original research publications and extracted data from the studies that met the criteria. Results: Around 8 randomized controlled trials involving 1078 patients were included. Reamed intramedullary nailing was associated with shorter time to consolidation of the fracture (SMD = –0.62, 95% CI = –0.89 to –0.35, P < 0.00001), lower secondary procedure rate (OR = 0.25, 95% CI 0.10–0.62, P = 0.003), lower nonunion rate (OR = 0.14, 95% CI = 0.05–0.40, P < 0.01), and lower delayed-union rate (OR = 0.19, 95% CI = 0.07–0.49, P < 0.01) compared to unreamed intramedullary nailing. The 2 groups showed no significant differences in risk of implant failure (OR = 0.50, 95% CI 0.14–1.74, P = 0.27), mortality risk (OR = 0.94, 95% CI 0.19–4.68, P = 0.94), risk of acute respiratory distress syndrome (ARDS; OR = 1.55, 95% CI 0.36–6.57, P = 0.55), or blood loss (SMD = 0.57, 95% CI = –0.22 to 1.36, P = 0.15). Conclusion: Reamed intramedullary nailing is correlated with shorter time to union and lower rates of delayed-union, nonunion, and reoperation. Reamed intramedullary nailing did not increase blood loss or the rates of ARDS, implant failure, and mortality compared to unreamed intramedullary nailing. Therefore, the treatment of femoral fractures using reamed intramedullary nailing is recommended. PMID:27442651

How Do Tissues Respond and Adapt to Stresses Around a Prosthesis? A Primer on Finite Element Stress Analysis for Orthopaedic Surgeons

PubMed Central

Brand, Richard A; Stanford, Clark M; Swan, Colby C

2003-01-01

Joint implant design clearly affects long-term outcome. While many implant designs have been empirically-based, finite element analysis has the potential to identify beneficial and deleterious features prior to clinical trials. Finite element analysis is a powerful analytic tool allowing computation of the stress and strain distribution throughout an implant construct. Whether it is useful depends upon many assumptions and details of the model. Since ultimate failure is related to biological factors in addition to mechanical, and since the mechanical causes of failure are related to load history, rather than a few loading conditions, chief among them is whether the stresses or strains under limited loading conditions relate to outcome. Newer approaches can minimize this and the many other model limitations. If the surgeon is to critically and properly interpret the results in scientific articles and sales literature, he or she must have a fundamental understanding of finite element analysis. We outline here the major capabilities of finite element analysis, as well as the assumptions and limitations. PMID:14575244

Long-term single-center experience of defibrillator therapy in children and adolescents.

PubMed

Frommeyer, Gerrit; Feder, Sebastian; Bettin, Markus; Debus, Volker; Köbe, Julia; Reinke, Florian; Uebing, Anselm; Eckardt, Lars; Kehl, Hans Gerd

2018-06-01

Implantable cardioverter-defibrillator (ICD) systems are established therapy for prevention of sudden cardiac death. Long-term data on ICD systems in children and adolescents is rare. The present study displays a long-term single-center follow-up of children and adolescents with ICD systems. The present study represents a single-center experience of patients younger than 18 years who received an ICD (n = 58). Follow-up data included in-house follow-up as well as examinations of collaborating specialists. Mean age at implantation was 14.0 ± 3.3 years and 33 patients (56.9%) were male. A transvenous ICD system was implanted in 54 patients (93.1%). In 33 patients (56.9%) electrical heart disease or idiopathic ventricular fibrillation represented the underlying condition of ICD implantation. Median follow-up duration was 70 months (45; 94). 3 patients (5.2%) died during the observation period. None of these deaths was associated with ICD failure. Appropriate shocks occurred in 32 patients (55.2%). Inappropriate shock delivery was recorded in 17 patients (29.3%). Supraventricular tachycardia represented the most frequent cause of inappropriate shock delivery (9 patients, 52.9%). T-wave oversensing led to inappropriate shock delivery in 3 patients (17.6%). In 5 patients (29.4%), lead failure caused inappropriate shock delivery. Of note, during follow-up lead failure was reported in 15 patients (25.9%) leading to surgical revision. ICD therapy in children and adolescents is effective for prevention of sudden cardiac death. The rate of appropriate shock deliveries was significantly higher as compared with large ICD trials. Inappropriate therapies occurred frequently. In particular supraventricular tachycardia, T-wave oversensing and lead failures were responsible for these episodes. Copyright © 2017 Elsevier B.V. All rights reserved.

Utility of the Seattle Heart Failure Model in patients with advanced heart failure.

PubMed

Kalogeropoulos, Andreas P; Georgiopoulou, Vasiliki V; Giamouzis, Grigorios; Smith, Andrew L; Agha, Syed A; Waheed, Sana; Laskar, Sonjoy; Puskas, John; Dunbar, Sandra; Vega, David; Levy, Wayne C; Butler, Javed

2009-01-27

The aim of this study was to validate the Seattle Heart Failure Model (SHFM) in patients with advanced heart failure (HF). The SHFM was developed primarily from clinical trial databases and extrapolated the benefit of interventions from published data. We evaluated the discrimination and calibration of SHFM in 445 advanced HF patients (age 52 +/- 12 years, 68.5% male, 52.4% white, ejection fraction 18 +/- 8%) referred for cardiac transplantation. The primary end point was death (n = 92), urgent transplantation (n = 14), or left ventricular assist device (LVAD) implantation (n = 3); a secondary analysis was performed on mortality alone. Patients were receiving optimal therapy (angiotensin-II modulation 92.8%, beta-blockers 91.5%, aldosterone antagonists 46.3%), and 71.0% had an implantable device (defibrillator 30.4%, biventricular pacemaker 3.4%, combined 37.3%). During a median follow-up of 21 months, 109 patients (24.5%) had an event. Although discrimination was adequate (c-statistic >0.7), the SHFM overall underestimated absolute risk (observed vs. predicted event rate: 11.0% vs. 9.2%, 21.0% vs. 16.6%, and 27.9% vs. 22.8% at 1, 2, and 3 years, respectively). Risk underprediction was more prominent in patients with an implantable device. The SHFM had different calibration properties in white versus black patients, leading to net underestimation of absolute risk in blacks. Race-specific recalibration improved the accuracy of predictions. When analysis was restricted to mortality, the SHFM exhibited better performance. In patients with advanced HF, the SHFM offers adequate discrimination, but absolute risk is underestimated, especially in blacks and in patients with devices. This is more prominent when including transplantation and LVAD implantation as an end point.

Scanning electron microscope fractography of induced fatigue-damaged saline breast implants.

PubMed

Brandon, H J; Jerina, K L; Savoy, T L; Wolf, C J

2006-01-01

Breast implant strength and durability is presently an important topic in biomaterials science. Research studies are being conducted to determine the mechanisms and rates of failure in order to assess the in vivo performance of breast implants. Fatigue life is a measure of breast implant durability since fatigue failure is a potential in vivo failure mechanism. This study describes the characterization of the fracture surface morphology of breast implant shell regions that have failed due to cyclic fatigue. Saline breast implants were fatigue tested to failure using a laboratory apparatus in which flat plates cyclically compressed the implants. The implants were unimplanted control devices of both textured and smooth saline implants. The failure surfaces of the fatigued shells were examined using scanning electron microscopy (SEM). The morphological features of the failure surfaces are described for implants with short and long fatigue lifetimes. The details of both the inside and outside surfaces of the shell at the failure location are described. Two different modes of failure were observed in both the textured and smooth shells. These modes depend on the magnitude of the cyclic load and corresponding number of fatigue cycles at failure. The first mode is a tear in the shell of about 18 mm in length, and the second mode is a pinhole approximately 1 mm in diameter. Details of the surface morphology for these two types of failure modes and shell thickness data are presented herein. There was no significant change in the crosslink density of the shell as a result of fatigue.

DEALING WITH DENTAL IMPLANT FAILURES

PubMed Central

Levin, Liran

2008-01-01

An implant-supported restoration offers a predictable treatment for tooth replacement. Reported success rates for dental implants are high. Nevertheless, failures that mandate immediate implant removal do occur. The consequences of implant removal jeopardize the clinician's efforts to accomplish satisfactory function and esthetics. For the patient, this usually involves further cost and additional procedures. The aim of this paper is to describe different methods and treatment modalities to deal with dental implant failure. The main topics for discussion include identifying the failing implant, implants replacing failed implants at the exact site, and the use of other restorative options. When an implant fails, a tailor made treatment plan should be provided to each patient according to all relevant variables. Patients should be informed regarding all possible treatment modalities following implant failure and give their consent to the most appropriate treatment option for them. PMID:19089213

Risk factors associated with early implant failure: A 5-year retrospective clinical study.

PubMed

Olmedo-Gaya, Maris Victoria; Manzano-Moreno, Francisco J; Cañaveral-Cavero, Esther; de Dios Luna-del Castillo, Juan; Vallecillo-Capilla, Manuel

2016-02-01

The replacement of lost teeth with dental implants is a widespread treatment whose associated problems are also frequently encountered. Nevertheless, the factors associated with early implant failure have not been well documented. Further analyses of the factors influencing osseointegration establishment are required to maximize the predictability of the procedure and minimize implant failures. The purpose of this retrospective clinical study was to explore the association between possible risk factors and early implant failure. This retrospective clinical study evaluated 142 participants who received 276 external connection BTI implants between 2007 and 2011. Participant variables (age, sex, systemic disease, tobacco use, alcohol consumption, bruxism, and degree of periodontal disease), implant variables (type of edentulism, localization, area, diameter, length, and bone quality), intervention variables (expansion mechanisms, sinus augmentation techniques, bone regeneration, and implant insertion), and postoperative variables (presence of pain/inflammation at 1 week postsurgery) were studied. A multilevel logistic regression model (mixed effects-type model) was used to determine the influence of variables on early implant failure. Early implant failure was significantly associated with the male sex (P=.001), severe periodontal disease (P=.005), short implants (P=.001), expansion technique (P=.002), and postoperative pain/inflammation at 1 week postsurgery (P<.001). Early dental implant failure is more frequent in men and in individuals with severe periodontal disease, short implants, pain/inflammation at 1 week postsurgery, or bone expansion treatment. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Implantable cardioverter defibrillators for primary prevention in patients with nonischemic cardiomyopathy: A systematic review and meta-analysis.

PubMed

Akel, Tamer; Lafferty, James

2017-06-01

Implantable cardioverter defibrillators (ICDs) have proved their favorable outcomes on survival in selected patients with cardiomyopathy. Although previous meta-analyses have shown benefit for their use in primary prevention, the evidence remains less robust for patients with nonischemic cardiomyopathy (NICM) in comparison to patients with coronary artery disease (CAD). To evaluate the effect of ICD therapy on reducing all-cause mortality and sudden cardiac death (SCD) in patients with NICM. PubMed (1993-2016), the Cochrane Central Register of Controlled Trials (2000-2016), reference lists of relevant articles, and previous meta-analyses. Search terms included defibrillator, heart failure, cardiomyopathy, randomized controlled trials, and clinical trials. Eligible trials were randomized controlled trials with at least an arm of ICD, an arm of medical therapy and enrolled some patients with NICM. The primary endpoint in the trials should include all-cause mortality or mortality from SCD. Hazard ratios (HRs) for all-cause mortality and mortality from SCD were either extracted or calculated along with their standard errors. Of the 1047 abstracts retained by the initial screen, eight randomized controlled trials were identified. Five of these trials reported relevant data regarding patients with NICM and were subsequently included in this meta-analysis. Pooled analysis of HRs suggested a statistically significant reduction in all-cause mortality among a total of 2573 patients randomized to ICD vs medical therapy (HR 0.80; 95% CI, 0.67-0.96; P=.02). Pooled analysis of HRs for mortality from SCD was also statistically significant (n=1677) (HR 0.51; 95% CI, 0.34-0.76; P=.001). ICD implantation is beneficial in terms of all-cause mortality and mortality from SCD in certain subgroups of patients with NICM. © 2017 John Wiley & Sons Ltd.

[Retrieval and failure analysis of surgical implants in Brazil: the need for proper regulation].

PubMed

Azevedo, Cesar R de Farias; Hippert, Eduardo

2002-01-01

This paper summarizes several cases of metallurgical failure analysis of surgical implants conducted at the Laboratory of Failure Analysis, Instituto de Pesquisas Tecnológicas (IPT), in Brazil. Failures with two stainless steel femoral compression plates, one stainless steel femoral nail plate, one Ti-6Al-4V alloy maxillary reconstruction plate, and five Nitinol wires were investigated. The results showed that the implants were not in accordance with ISO standards and presented evidence of corrosion-assisted fracture. Furthermore, some of the implants presented manufacturing/processing defects which also contributed to their premature failure. Implantation of materials that are not biocompatible may cause several types of adverse effects in the human body and lead to premature implant failure. A review of prevailing health legislation is needed in Brazil, along with the adoption of regulatory mechanisms to assure the quality of surgical implants on the market, providing for compulsory procedures in the reporting and investigation of surgical implants which have failed in service.

Multicentre clinical trial experience with the HeartMate 3 left ventricular assist device: 30-day outcomes.

PubMed

Zimpfer, Daniel; Netuka, Ivan; Schmitto, Jan D; Pya, Yuriy; Garbade, Jens; Morshuis, Michiel; Beyersdorf, Friedhelm; Marasco, Silvana; Rao, Vivek; Damme, Laura; Sood, Poornima; Krabatsch, Thomas

2016-09-01

The objective of this study was to describe the operative experience and 30-day outcomes of patients implanted with the HeartMate 3 Left Ventricular Assist System (LVAS) during the Conformité Européenne (CE) Mark clinical trial. Adult patients met inclusion and exclusion criteria defining advanced-stage heart failure and included the indications of bridge to transplant and destination therapy. Operative parameters, outcomes, adverse events, physical status and quality-of-life parameters were assessed in the first 30 days after LVAS implant. Fifty patients were implanted with the HeartMate 3 at 10 centres in 6 countries. The 30-day survival rate was 98%. The median operative and cardiopulmonary bypass times were 200 (range: 95-585) min and 84 (range: 47-250) min, respectively. Patients required transfusion with packed red blood cells (3.6 ± 2.3 units), fresh frozen plasma (6.5 ± 5 units) and platelets (2 ± 1 units). Six patients (12%) required reoperation for postoperative bleeding and 10 patients (20%) did not require blood transfusion. The median intensive care time was 6 days (range: 1-112 days) and the total hospital stay was 28 days (range: 14-116 days). The most common adverse events were bleeding (15, 30%), arrhythmia (14, 28%) and infection (10, 20%). There were 2 (4%) strokes. The 30-day outcomes following implantation of the HeartMate 3 demonstrates excellent survival with low adverse event rates. The LVAD performed as intended with no haemolysis or device failure. NCT02170363. HeartMate 3™ CE Mark Clinical Investigation Plan (HM3 CE Mark). © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Socket grafting with or without buccal augmentation with anorganic bovine bone at immediate post-extractive implants: 6-month after loading results from a multicenter randomised controlled clinical trial.

PubMed

Zuffetti, Francesco; Esposito, Marco; Capelli, Matteo; Galli, Fabio; Testori, Tiziano; Del Fabbro, Massimo

2013-01-01

To evaluate whether grafting with additional anorganic bovine bone to augment horizontally the buccal plate (internal and external grafting [IEG]) at single post-extractive implants preserves the alveolar ridge, improving aesthetics, better than internal socket grafting alone (ISGA). A total of 78 patients, treated in four Italian private practices, requiring a single immediate post-extractive implant, having at least 1 mm of implant-to-buccal bone gap after implant insertion and a preserved buccal bone, had the residual bone-to-implant gap filled with anorganic bovine bone. Thirty-nine randomly allocated patients received additional buccal horizontal augmentation of about 2 mm thickness with the same bone substitute (IEG group) covered with collagen resorbable membranes. Implants were submerged for 4 months before being loaded with provisional acrylic crowns. Definitive crowns were delivered after 6 months. Outcome measures were crown/implant failures, complications and aesthetics recorded by blinded assessors 6 months after initial loading, at delivery of definitive crowns. Six months after initial loading, 8 patients dropped out, did not complete the treatment or were treated twice and therefore had to be excluded (4 from each group). There were no statistically significant differences for implant failures and complications between the two groups. Two implants failed in the IEG group versus 1 in the ISGA group. Four complications occurred, 2 in each group. The mean implant aesthetic score (IAS) was 7.8 at ISGA sites and 8.0 at IEG sites. There were no statistically significant differences between the two groups (P = 0.492; difference 0.2 mm; 95% CI -0.769, 0.369) for IAS score. There were no statistically significant differences in the outcomes between the centres. The use of adjunctive anorganic bovine bone placed buccally at preserved buccal sites of immediate post-extractive implants may not improve the aesthetic outcome, however additional research is needed to confirm or reject these preliminary findings.

First permanent implant of the Jarvik 2000 Heart.

PubMed

Westaby, S; Banning, A P; Jarvik, R; Frazier, O H; Pigott, D W; Jin, X Y; Catarino, P A; Saito, S; Robson, D; Freeland, A; Myers, T J; Poole-Wilson, P A

2000-09-09

Heart failure is a major public-health concern. Quality and duration of life on maximum medical therapy are poor. The availability of donor hearts is severely limited, therefore an alternative approach is necessary. We have explored the use of a new type of left-ventricular assist device intended as a long-term solution to end-stage heart failure. As part of a prospective clinical trial, we implanted the first permanent Jarvik 2000 Heart--an intraventricular device with an innovative power delivery system--into a 61-year-old man (New York Heart Association functional class IV) with dilated cardiomyopathy. We assessed the effect of this left-ventricular assist device on both native heart function and the symptoms and systemic characteristics of heart failure. The Jarvik 2000 Heart sustained the patient's circulation, and was practical and user-friendly. After 6 weeks, exercise tolerance, myocardial function, and end-organ function improved. Symptoms of heart failure have resolved, and continuous decreased pulse-pressure perfusion has had no adverse effects in the short term. There has been no significant haemolysis and no device-related complications. The skull-mounted pedestal is unobtrusive and has healed well. The initial success of this procedure raises the possibility of a new treatment for end-stage heart failure. In the longer term, its role will be determined by mechanical reliability.

Short dental implants: an emerging concept in implant treatment.

PubMed

Al-Hashedi, Ashwaq Ali; Taiyeb Ali, Tara Bai; Yunus, Norsiah

2014-06-01

Short implants have been advocated as a treatment option in many clinical situations where the use of conventional implants is limited. This review outlines the effectiveness and clinical outcomes of using short implants as a valid treatment option in the rehabilitation of edentulous atrophic alveolar ridges. Initially, an electronic search was performed on the following databases: Medline, PubMed, Embase, Cochrane Database of Systematic Reviews, and DARE using key words from January 1990 until May 2012. An additional hand search was included for the relevant articles in the following journals: International Journal of Oral and Maxillofacial Implants, Clinical Oral Implants Research, Journal of Clinical Periodontology, International Journal of Periodontics, Journal of Periodontology, and Clinical Implant Dentistry and Related Research. Any relevant papers from the journals' references were hand searched. Articles were included if they provided detailed data on implant length, reported survival rates, mentioned measures for implant failure, were in the English language, involved human subjects, and researched implants inserted in healed atrophic ridges with a follow-up period of at least 1 year after implant-prosthesis loading. Short implants demonstrated a high rate of success in the replacement of missing teeth in especially atrophic alveolar ridges. The advanced technology and improvement of the implant surfaces have encouraged the success of short implants to a comparable level to that of standard implants. However, further randomized controlled clinical trials and prospective studies with longer follow-up periods are needed.

Five-Year Pooled Data Analysis of the Ahmed Baerveldt Comparison Study and the Ahmed Versus Baerveldt Study.

PubMed

Christakis, Panos G; Zhang, Dongyu; Budenz, Donald L; Barton, Keith; Tsai, James C; Ahmed, Iqbal I K

2017-04-01

To determine the relative efficacy of the Ahmed-FP7 and Baerveldt BG101-350 implants. Pooled analysis of 2 multicenter, randomized clinical trials. A total of 514 patients aged 18 or older with uncontrolled glaucoma that had failed or were at high risk of failing trabeculectomy were randomized to receive an Ahmed implant (n = 267) or Baerveldt implant (n = 247). Cumulative failure rates (using an intraocular pressure [IOP] target of 6-18 mm Hg inclusive), de novo glaucoma surgery rates, mean IOP, mean glaucoma medication use, and visual acuity were compared. Baseline characteristics were similar between groups. Mean preoperative IOP of the study population was 31.5 ± 11.3 mm Hg on an average of 3.3 ± 1.1 glaucoma medications. At 5 years, mean IOP was 15.8 ± 5.2 mm Hg in the Ahmed group and 13.2 ± 4.7 mm Hg in the Baerveldt group (P < .001). Mean glaucoma medication use was 1.9 ± 1.5 in the Ahmed group and 1.5 ± 1.4 in the Baerveldt group (P = .007). The cumulative failure rate at 5 years was 49% in the Ahmed group and 37% in the Baerveldt group (P = .007). High IOP was the most common reason for failure in both groups, and de novo glaucoma surgery was required in 16% of the Ahmed group and 8% of the Baerveldt group (P = .006). Failure owing to hypotony occurred in 0.4% of the Ahmed group and 4.5% of the Baerveldt group (P = .002). Visual outcomes were similar between groups (P = .90). The Baerveldt group had a lower failure rate, lower rate of de novo glaucoma surgery, and lower mean IOP on fewer medications than the Ahmed group. Baerveldt implantation carried a higher risk of hypotony. Copyright © 2017 Elsevier Inc. All rights reserved.

Modes of failure of Osteonics constrained tripolar implants: a retrospective analysis of forty-three failed implants.

PubMed

Guyen, Olivier; Lewallen, David G; Cabanela, Miguel E

2008-07-01

The Osteonics constrained tripolar implant has been one of the most commonly used options to manage recurrent instability after total hip arthroplasty. Mechanical failures were expected and have been reported. The purpose of this retrospective review was to identify the observed modes of failure of this device. Forty-three failed Osteonics constrained tripolar implants were revised at our institution between September 1997 and April 2005. All revisions related to the constrained acetabular component only were considered as failures. All of the devices had been inserted for recurrent or intraoperative instability during revision procedures. Seven different methods of implantation were used. Operative reports and radiographs were reviewed to identify the modes of failure. The average time to failure of the forty-three implants was 28.4 months. A total of five modes of failure were observed: failure at the bone-implant interface (type I), which occurred in eleven hips; failure at the mechanisms holding the constrained liner to the metal shell (type II), in six hips; failure of the retaining mechanism of the bipolar component (type III), in ten hips; dislocation of the prosthetic head at the inner bearing of the bipolar component (type IV), in three hips; and infection (type V), in twelve hips. The mode of failure remained unknown in one hip that had been revised at another institution. The Osteonics constrained tripolar total hip arthroplasty implant is a complex device involving many parts. We showed that failure of this device can occur at most of its interfaces. It would therefore appear logical to limit its application to salvage situations.

Cadaveric study validating in vitro monitoring techniques to measure the failure mechanism of glenoid implants against clinical CT.

PubMed

Junaid, Sarah; Gregory, Thomas; Fetherston, Shirley; Emery, Roger; Amis, Andrew A; Hansen, Ulrich

2018-03-23

Definite glenoid implant loosening is identifiable on radiographs, however, identifying early loosening still eludes clinicians. Methods to monitor glenoid loosening in vitro have not been validated to clinical imaging. This study investigates the correlation between in vitro measures and CT images. Ten cadaveric scapulae were implanted with a pegged glenoid implant and fatigue tested to failure. Each scapulae were cyclically loaded superiorly and CT scanned every 20,000 cycles until failure to monitor progressive radiolucent lines. Superior and inferior rim displacements were also measured. A finite element (FE) model of one scapula was used to analyze the interfacial stresses at the implant/cement and cement/bone interfaces. All ten implants failed inferiorly at the implant-cement interface, two also failed at the cement-bone interface inferiorly, and three showed superior failure. Failure occurred at of 80,966 ± 53,729 (mean ± SD) cycles. CT scans confirmed failure of the fixation, and in most cases, was observed either before or with visual failure. Significant correlations were found between inferior rim displacement, vertical head displacement and failure of the glenoid implant. The FE model showed peak tensile stresses inferiorly and high compressive stresses superiorly, corroborating experimental findings. In vitro monitoring methods correlated to failure progression in clinical CT images possibly indicating its capacity to detect loosening earlier for earlier clinical intervention if needed. Its use in detecting failure non-destructively for implant development and testing is also valuable. The study highlights failure at the implant-cement interface and early signs of failure are identifiable in CT images. © 2018 The Authors. Journal of Orthopaedic Research ® Published by Wiley Periodicals, Inc. on behalf of the Orthopaedic Research Society. J Orthop Res 9999:XX-XX, 2018. © 2018 The Authors. Journal of Orthopaedic Research® Published by Wiley Periodicals, Inc. on behalf of the Orthopaedic Research Society.

Implantation in assisted reproduction: a look at endometrial receptivity.

PubMed

Fatemi, H M; Popovic-Todorovic, B

2013-11-01

Implantation failure in assisted reproduction is thought to be mainly due to impaired uterine receptivity. With normal uterine anatomy, changes in endocrine profile during ovarian stimulation and medical conditions of the mother (i.e. thrombophilia and abnormal immunological response) could result in a non-receptive endometrium. High oestradiol concentrations during ovarian stimulation lead to premature progesterone elevation, causing endometrial advancement and hampering implantation, which can be overcome by a freeze-all approach and embryo transfer in natural cycles or by milder stimulation protocols. Patients with recurrent implantation failure (RIF) should be tested for inherited and acquired thrombophilias. Each patient should be individually assessed and counselled regarding therapy with low-molecular-weight heparin (LMWH). Empirical treatment with LMWH, aspirin or corticosteroids is not effective for women with RIF who have negative thrombophilic tests. If thrombophilic tests are normal, patients should be tested for immunological causes. If human leukocyte antigen dissimilarity is proven, treatment with intravenous immunoglobulin might be beneficial. Preliminary observational studies using intralipid infusion in the presence of increased natural killer cytotoxic activity are interesting but the proposed rationale is controversial and randomized controlled trials are needed. Hysteroscopy and/or endometrial scratching in the cycle preceding ovarian stimulation should become standard for patients with RIF. Copyright © 2013 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

Inverse Relationship of Blood Pressure to Long-Term Outcomes and Benefit of Cardiac Resynchronization Therapy in Patients With Mild Heart Failure: A Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy Long-Term Follow-Up Substudy.

PubMed

Biton, Yitschak; Moss, Arthur J; Kutyifa, Valentina; Mathias, Andrew; Sherazi, Saadia; Zareba, Wojciech; McNitt, Scott; Polonsky, Bronislava; Barsheshet, Alon; Brown, Mary W; Goldenberg, Ilan

2015-09-01

Previous studies have shown that low blood pressure is associated with increased mortality and heart failure (HF) in patients with left ventricular dysfunction. Cardiac resynchronization therapy (CRT) was shown to increase systolic blood pressure (SBP). Therefore, we hypothesized that treatment with CRT would provide incremental benefit in patients with lower SBP values. The independent contribution of SBP to outcome was analyzed in 1267 patients with left bundle brunch block enrolled in Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy (MADIT-CRT). SBP was assessed as continuous measures and further categorized into approximate quintiles. The risk of long-term HF or death and CRT with defibrillator versus implantable cardioverter defibrillator benefit was assessed in multivariate Cox proportional hazards regression models. Multivariate analysis showed that in the implantable cardioverter defibrillator arm, each 10-mm Hg decrement of SBP was independently associated with a significant 21% (P<0.001) increased risk for HF or death, and patients with lower quintile SBP (<110 mm Hg) experienced a corresponding >2-fold risk-increase. CRT with defibrillator provided the greatest HF or mortality risk reduction in patients with SBP<110 mm Hg hazard ratio of 0.34, P<0.001, when compared with hazard ratio of 0.52, P<0.001, in those with 110>SBP≥136 mm Hg and hazard ratio of 0.94, P=0.808, with SBP>136 mm Hg (P for trend=0.001). In patients with mild HF, prolonged QRS, and left bundle brunch block, low SBP is related to higher risk of mortality or HF with implantable cardioverter defibrillator therapy alone. Treatment with CRT is associated with incremental clinical benefits in patients with lower baseline SBP values. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00180271. © 2015 American Heart Association, Inc.

Revisiting the stability of mini-implants used for orthodontic anchorage.

PubMed

Yao, Chung-Chen Jane; Chang, Hao-Hueng; Chang, Jenny Zwei-Chieng; Lai, Hsiang-Hua; Lu, Shao-Chun; Chen, Yi-Jane

2015-11-01

The aim of this study is to comprehensively analyze the potential factors affecting the failure rates of three types of mini-implants used for orthodontic anchorage. Data were collected on 727 mini-implants (miniplates, predrilled titanium miniscrews, and self-drilling stainless steel miniscrews) in 220 patients. The factors related to mini-implant failure were investigated using a Chi-square test for univariate analysis and a generalized estimating equation model for multivariate analysis. The failure rate for miniplates was significantly lower than for miniscrews. All types of mini-implants, especially the self-drilling stainless steel miniscrews, showed decreased stability if the previous implantation had failed. The stability of predrilled titanium miniscrews and self-drilling stainless steel miniscrews were comparable at the first implantation. However, the failure rate of stainless steel miniscrews increased at the second implantation. The univariate analysis showed that the following variables had a significant influence on the failure rates of mini-implants: age of patient, type of mini-implant, site of implantation, and characteristics of the soft tissue around the mini-implants. The generalized estimating equation analysis revealed that mini-implants with miniscrews used in patients younger than 35 years, subjected to orthodontic loading after 30 days and implanted on the alveolar bone ridge, have a significantly higher risk of failure. This study revealed that once the dental surgeon becomes familiar with the procedure, the stability of orthodontic mini-implants depends on the type of mini-implant, age of the patient, implantation site, and the healing time of the mini-implant. Miniplates are a more feasible anchorage system when miniscrews fail repeatedly. Copyright © 2014. Published by Elsevier B.V.

Daily remote monitoring of implantable cardioverter-defibrillators: insights from the pooled patient-level data from three randomized controlled trials (IN-TIME, ECOST, TRUST).

PubMed

Hindricks, Gerhard; Varma, Niraj; Kacet, Salem; Lewalter, Thorsten; Søgaard, Peter; Guédon-Moreau, Laurence; Proff, Jochen; Gerds, Thomas A; Anker, Stefan D; Torp-Pedersen, Christian

2017-06-07

Remote monitoring of implantable cardioverter-defibrillators may improve clinical outcome. A recent meta-analysis of three randomized controlled trials (TRUST, ECOST, IN-TIME) using a specific remote monitoring system with daily transmissions [Biotronik Home Monitoring (HM)] demonstrated improved survival. We performed a patient-level analysis to verify this result with appropriate time-to-event statistics and to investigate further clinical endpoints. Individual data of the TRUST, ECOST, and IN-TIME patients were pooled to calculate absolute risks of endpoints at 1-year follow-up for HM vs. conventional follow-up. All-cause mortality analysis involved all three trials (2405 patients). Other endpoints involved two trials, ECOST and IN-TIME (1078 patients), in which an independent blinded endpoint committee adjudicated the underlying causes of hospitalizations and deaths. The absolute risk of death at 1 year was reduced by 1.9% in the HM group (95% CI: 0.1-3.8%; P = 0.037), equivalent to a risk ratio of 0.62. Also the combined endpoint of all-cause mortality or hospitalization for worsening heart failure (WHF) was significantly reduced (by 5.6%; P = 0.007; risk ratio 0.64). The composite endpoint of all-cause mortality or cardiovascular (CV) hospitalization tended to be reduced by a similar degree (4.1%; P = 0.13; risk ratio 0.85) but without statistical significance. In a pooled analysis of the three trials, HM reduced all-cause mortality and the composite endpoint of all-cause mortality or WHF hospitalization. The similar magnitudes of absolute risk reductions for WHF and CV endpoints suggest that the benefit of HM is driven by the prevention of heart failure exacerbation.

Clinical Management of Implant Prostheses in Patients with Bruxism

PubMed Central

Komiyama, Osamu; Lobbezoo, Frank; De Laat, Antoon; Iida, Takashi; Kitagawa, Tsuyoshi; Murakami, Hiroshi; Kato, Takao; Kawara, Misao

2012-01-01

There is general agreement that excessive stress to the bone-implant interface may result in implant overload and failure. Early failure of the implant due to excessive loading occurs shortly after uncovering the implant. Excess load on a final restoration after successful implant integration can result in physical failure of the implant structure. Many clinicians believe that overload of dental implants is a risk factor for vertical peri-implant bone loss and/or may be detrimental for the suprastructure in implant prostheses. It has been documented that occlusal parafunction, such as, bruxism (tooth grinding and clenching) affects the outcome of implant prostheses, but there is no evidence for a causal relation between the failures and overload of dental implants. In spite of this lack of evidence, often metal restorations are preferred instead of porcelain for patients in whom bruxism is presumed on the basis of tooth wear. The purpose of this paper is to discuss the importance of the occlusal scheme used in implant restorations for implant longevity and to suggest a clinical approach and occlusal materials for implant prostheses in order to prevent complications related to bruxism. PMID:22701484

A retrospective study on clinical and radiological outcomes of oral implants in patients followed up for a minimum of 20 years.

PubMed

Chrcanovic, Bruno Ramos; Kisch, Jenö; Albrektsson, Tomas; Wennerberg, Ann

2018-04-01

Very long-term follow-up of oral implants is seldom reported in the literature. To assess oral implant failure rates and marginal bone loss (MBL) of patients followed up for a minimum of 20 years. Implants placed in patients followed up for 20+ years were included. Descriptive statistics, survival analyses, generalized estimating equations were performed. Three-hundred implants were randomly selected for MBL. 1,045 implants (227 patients) were included. Implant location, irradiation, and bruxism affected the implant survival rate. Thirty-five percent of the failures occurred within the first year after implantation, and another 26.8% in the second/third year. There was a cumulative survival rate of 87.8% after 36 years of follow-up. In the last radiological follow up, 35 implants (11.7%) had bone gain, and 35 implants (11.7%) presented at least 3 mm of MBL. Twenty-six out of 86 failed implants with available radiograms presented severe MBL in the last radiological register before implant failure. Most of the implant failures occurred at the first few years after implantation, regardless of a very long follow up. MBL can be insignificant in long-term observations, but it may, nevertheless, be the cause of secondary failure of oral implants in some cases. © 2017 Wiley Periodicals, Inc.

Characteristics of early versus late implant failure: a retrospective study.

PubMed

Manor, Yifat; Oubaid, Saheer; Mardinger, Ofer; Chaushu, Gavriel; Nissan, Joseph

2009-12-01

Implant failures can be divided into early and late according to the timing of failure. The purpose of this study was to characterize and compare both types. A retrospective cohort study was conducted in 194 patients (98 men and 96 women) who presented after dental implant failures during a 6-year period (2000 to 2006). The patient served as the unit of analysis. A history of at least 1 failed and removed dental implant served as the inclusion criterion. Patients were excluded from this study whenever their files had missing data. The collected data included a patient's characteristics, failure characteristics, and the anatomic status of the alveolar ridge after failure. Late failures were associated with moderate to severe bone loss, a larger number of failed implants per patient, a higher incidence in men, and mostly in posterior areas. Early failures were associated with minimal bone loss, occurred more in women, at a younger age, and in most cases the implants were intended to support single crowns. Meticulous follow-up is needed to reveal and treat failing or ailing implants. Once established as hopeless, they should be removed as soon as possible to prevent further bone loss.

Systematic review and meta-analysis of randomized controlled trials for the management of limited vertical height in the posterior region: short implants (5 to 8 mm) vs longer implants (> 8 mm) in vertically augmented sites.

PubMed

Lee, Sung-Ah; Lee, Chun-Teh; Fu, Martin M; Elmisalati, Waiel; Chuang, Sung-Kiang

2014-01-01

The aim of this study was to undertake a systematic review with meta-analysis on randomized controlled trials (RCTs) to compare the rates of survival, success, and complications of short implants to those of longer implants in the posterior regions. Electronic literature searches were conducted through the MEDLINE (PubMed) and EMBASE databases to locate all relevant articles published between January 1, 1990, and April 30, 2013. Eligible studies were selected based on inclusion criteria, and quality assessments were conducted. After data extraction, meta-analyses were performed. In total, 539 dental implants (265 short implants [length 5 to 8 mm] and 274 control implants [length > 8 mm]) from four RCTs were included. The fixed prostheses of multiple short and control implants were all splinted. The mean follow-up period was 2.1 years. The 1-year and 5-year cumulative survival rates (CSR) were 98.7% (95% confidence interval [CI], 97.8% to 99.5%) and 93.6% (95% CI, 89.8% to 97.5%), respectively, for the short implant group and 98.0% (95% CI, 96.9% to 99.1%) and 90.3% (95% CI, 85.2% to 95.4%), respectively, for the control implant group. The CSRs of the two groups did not demonstrate a statistically significant difference. There were also no statistically significant differences in success rates, failure rates, or complications between the two groups. Placement of short dental implants could be a predictable alternative to longer implants to reduce surgical complications and patient morbidity in situations where vertical augmentation procedures are needed. However, only four studies with potential risk of bias were selected in this meta-analysis. Within the limitations of this meta-analysis, these results should be confirmed with robust methodology and RCTs with longer follow-up duration.

Standardizing the evaluation criteria on treatment outcomes of mandibular implant overdentures: a systematic review

PubMed Central

Kim, Ha-Young; Shin, Sang-Wan

2014-01-01

PURPOSE The aim of this review was to analyze the evaluation criteria on mandibular implant overdentures through a systematic review and suggest standardized evaluation criteria. MATERIALS AND METHODS A systematic literature search was conducted by PubMed search strategy and hand-searching of relevant journals from included studies considering inclusion and exclusion criteria. Randomized clinical trials (RCT) and clinical trial studies comparing attachment systems on mandibular implant overdentures until December, 2011 were selected. Twenty nine studies were finally selected and the data about evaluation methods were collected. RESULTS Evaluation criteria could be classified into 4 groups (implant survival, peri-implant tissue evaluation, prosthetic evaluation, and patient satisfaction). Among 29 studies, 21 studies presented implant survival rate, while any studies reporting implant failure did not present cumulative implant survival rate. Seventeen studies evaluating peri-implant tissue status presented following items as evaluation criteria; marginal bone level (14), plaque Index (13), probing depth (8), bleeding index (8), attachment gingiva level (8), gingival index (6), amount of keratinized gingiva (1). Eighteen studies evaluating prosthetic maintenance and complication also presented following items as evaluation criteria; loose matrix (17), female detachment (15), denture fracture (15), denture relining (14), abutment fracture (14), abutment screw loosening (11), and occlusal adjustment (9). Atypical questionnaire (9), Visual analog scales (VAS) (4), and Oral Health Impact Profile (OHIP) (1) were used as the format of criteria to evaluate patients satisfaction in 14 studies. CONCLUSION For evaluation of implant overdenture, it is necessary to include cumulative survival rate for implant evaluation. It is suggested that peri-implant tissue evaluation criteria include marginal bone level, plaque index, bleeding index, probing depth, and attached gingiva level. It is also suggested that prosthetic evaluation criteria include loose matrix, female detachment, denture fracture, denture relining, abutment fracture, abutment screw loosening, and occlusal adjustment. Finally standardized criteria like OHIP-EDENT or VAS are required for patient satisfaction. PMID:25352954

The influence of prophylactic antibiotic administration on post-operative morbidity in dental implant surgery. A prospective double blind randomized controlled clinical trial.

PubMed

Nolan, Rory; Kemmoona, Maher; Polyzois, Ioannis; Claffey, Noel

2014-02-01

A prospective double-blind randomised controlled trial was conducted to test the effect of prophylactic antibiotics on post-operative morbidity and osseointegration of dental implants. Fifty-five subjects scheduled for implant surgery were enrolled. The patients were randomly assigned to the antibiotic (test group) and placebo (control group). Twenty-seven patients (test group) received 3 g amoxicillin one hour pre-operatively, and 28 patients (control group) received placebo capsules 1 h pre-operatively. No post-operative antibiotics were prescribed. Pain diaries and interference with daily activities diaries were kept by the patients for 1 week post-operatively. Signs of post-operative morbidity (swelling, bruising, suppuration and wound dehiscence) were recorded by the principal investigators at day 2 and day 7 following the operation. Osseointegration was assessed at 2nd stage surgery or 3-4 months post-operatively. The results of this study suggest that the use of prophylactic pre-operative antibiotics may result in higher dental implant survival rates (100% vs. 82%). Five implant failures, one in each of five patients, were reported in the placebo group and none in the antibiotic group (P = 0.0515). No significant differences were found for most of the signs of post-operative morbidity 2 and 7 days post-operatively. Only bruising at 2 days following the operation appeared to be higher in the placebo group (P = 0.0511). Post-operative pain (P = 0.01) and interference with daily activities (P = 0.01) appeared to be significantly lower for the antibiotic group after 7 days. Those patients with implant failure reported higher pain (based on the VAS scores) after 2 days (P = 0.003) and after 7 days (P = 0.0005), higher pain (based on the amount of analgesics used) after 7 days (P = 0.001) and higher interference with daily activities (based on the VAS scores) after 2 days (P = 0.005). The use of for dental implant surgery may be justified, as it appears to improve implant survival in the short term and also results in less post-operative pain and interference with daily activities. From the results of this study, it appears that prophylactic antibiotics may also be beneficial both in terms of implant survival, especially when the surgical procedure is prolonged due to its difficulty, high number of implants placed or operator's inexperience. © 2013 John Wiley & Sons A/S. Published by Blackwell Publishing Ltd.

Failure analysis of fractured dental zirconia implants.

PubMed

Gahlert, M; Burtscher, D; Grunert, I; Kniha, H; Steinhauser, E

2012-03-01

The purpose of the present study was the macroscopic and microscopic failure analysis of fractured zirconia dental implants. Thirteen fractured one-piece zirconia implants (Z-Look3) out of 170 inserted implants with an average in situ period of 36.75±5.34 months (range from 20 to 56 months, median 38 months) were prepared for macroscopic and microscopic (scanning electron microscopy [SEM]) failure analysis. These 170 implants were inserted in 79 patients. The patient histories were compared with fracture incidences to identify the reasons for the failure of the implants. Twelve of these fractured implants had a diameter of 3.25 mm and one implant had a diameter of 4 mm. All fractured implants were located in the anterior side of the maxilla and mandibula. The patient with the fracture of the 4 mm diameter implant was adversely affected by strong bruxism. By failure analysis (SEM), it could be demonstrated that in all cases, mechanical overloading caused the fracture of the implants. Inhomogeneities and internal defects of the ceramic material could be excluded, but notches and scratches due to sandblasting of the surface led to local stress concentrations that led to the mentioned mechanical overloading by bending loads. The present study identified a fracture rate of nearly 10% within a follow-up period of 36.75 months after prosthetic loading. Ninety-two per cent of the fractured implants were so-called diameter reduced implants (diameter 3.25 mm). These diameter reduced implants cannot be recommended for further clinical use. Improvement of the ceramic material and modification of the implant geometry has to be carried out to reduce the failure rate of small-sized ceramic implants. Nevertheless, due to the lack of appropriate laboratory testing, only clinical studies will demonstrate clearly whether and how far the failure rate can be reduced. © 2011 John Wiley & Sons A/S.

Clinical retrospective study of self-reported penicillin allergy on dental implant failures and infections.

PubMed

French, David; Noroozi, Mehdi; Shariati, Batoul; Larjava, Hannu

2016-01-01

The aim of this retrospective study was to investigate whether self-reported allergy to penicillin may contribute to a higher rate of postsurgical infection and implant failure. This retrospective, non-interventional, open cohort study reports on implant survival and infection complications of 5,576 implants placed in private practice by one periodontist, and includes 4,132 implants that were followed for at least 1 year. Logistic regression was applied to examine the relationship between self-reported allergy to penicillin and implant survival, while controlling for potential confounders such as smoking, implant site, bone augmentation, loading protocol, immediate implantation, and bone level at baseline. The cumulative survival rate (CSR) was calculated according to the life table method and the Cox proportional hazard model was fitted to data. Out of 5,106 implants placed in patients taking penicillin it was found that 0.8% failed, while 2.1% failed of the 470 implants placed for patients with self-reported allergy to penicillin (P = .002). Odds of failure for implants placed in penicillin-allergic patients were 3.1 times higher than in non-allergic patients. For immediate implant placement, penicillin-allergic patients had a failure rate 10-times higher than the non-allergic cohort. Timing of implant failure occurring within 6 months following implantation was 80% in the penicillin-allergic group versus 54% in the non-allergic group. From the 48 implant sites showing postoperative infection: penicillin-allergic patients had an infection rate of 3.4% (n = 16/470) versus 0.6% in the non-allergic group (n = 32/5,106) (P < .05). Self-reported penicillin allergy was associated with a higher rate of infection, and primarily affected early implant failure.

Mineralocorticoid receptor antagonists for heart failure: a real‐life observational study

PubMed Central

Bruno, Noemi; Sinagra, Gianfranco; Paolillo, Stefania; Bonomi, Alice; Corrà, Ugo; Piepoli, Massimo; Veglia, Fabrizio; Salvioni, Elisabetta; Lagioia, Rocco; Metra, Marco; Limongelli, Giuseppe; Cattadori, Gaia; Scardovi, Angela B.; Carubelli, Valentina; Scrutino, Domenico; Badagliacca, Roberto; Guazzi, Marco; Raimondo, Rosa; Gentile, Piero; Magrì, Damiano; Correale, Michele; Parati, Gianfranco; Re, Federica; Cicoira, Mariantonietta; Frigerio, Maria; Bussotti, Maurizio; Vignati, Carlo; Oliva, Fabrizio; Mezzani, Alessandro; Vergaro, Giuseppe; Di Lenarda, Andrea; Passino, Claudio; Sciomer, Susanna; Pacileo, Giuseppe; Ricci, Roberto; Contini, Mauro; Apostolo, Anna; Palermo, Pietro; Mapelli, Massimo; Carriere, Cosimo; Clemenza, Francesco; Binno, Simone; Belardinelli, Romualdo; Lombardi, Carlo; Perrone Filardi, Pasquale; Emdin, Michele

2018-01-01

Abstract Aims Mineralocorticoid receptor antagonists (MRAs) have been demonstrated to improve outcomes in reduced ejection fraction heart failure (HFrEF) patients. However, MRAs added to conventional treatment may lead to worsening of renal function and hyperkalaemia. We investigated, in a population‐based analysis, the long‐term effects of MRA treatment in HFrEF patients. Methods and results We analysed data of 6046 patients included in the Metabolic Exercise Cardiac Kidney Index score dataset. Analysis was performed in patients treated (n = 3163) and not treated (n = 2883) with MRA. The study endpoint was a composite of cardiovascular death, urgent heart transplantation, or left ventricular assist device implantation. Ten years' survival was analysed through Kaplan–Meier, compared by log‐rank test and propensity score matching. At 10 years' follow‐up, the MRA‐untreated group had a significantly lower number of events than the MRA‐treated group (P < 0.001). MRA‐treated patients had more severe heart failure (higher New York Heart Association class and lower left ventricular ejection fraction, kidney function, and peak VO2). At a propensity‐score‐matching analysis performed on 1587 patients, MRA‐treated and MRA‐untreated patients showed similar study endpoint values. Conclusions In conclusion, MRA treatment does not affect the composite of cardiovascular death, urgent heart transplantation or left ventricular assist device implantation in a real‐life setting. A meticulous patient follow‐up, as performed in trials, is likely needed to match the positive MRA‐related benefits observed in clinical trials. PMID:29397584

Cost-Effectiveness of Remote Cardiac Monitoring With the CardioMEMS Heart Failure System.

PubMed

Schmier, Jordana K; Ong, Kevin L; Fonarow, Gregg C

2017-07-01

Heart failure (HF) is a leading cause of cardiovascular mortality in the United States and presents a substantial economic burden. A recently approved implantable wireless pulmonary artery pressure remote monitor, the CardioMEMS HF System, has been shown to be effective in reducing hospitalizations among New York Heart Association (NYHA) class III HF patients. The objective of this study was to estimate the cost-effectiveness of this remote monitoring technology compared to standard of care treatment for HF. A Markov cohort model relying on the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients) clinical trial for mortality and hospitalization data, published sources for cost data, and a mix of CHAMPION data and published sources for utility data, was developed. The model compares outcomes over 5 years for implanted vs standard of care patients, allowing patients to accrue costs and utilities while they remain alive. Sensitivity analyses explored uncertainty in input parameters. The CardioMEMS HF System was found to be cost-effective, with an incremental cost-effectiveness ratio of $44,832 per quality-adjusted life year (QALY). Sensitivity analysis found the model was sensitive to the device cost and to whether mortality benefits were sustained, although there were no scenarios in which the cost/QALY exceeded $100,000. Compared with standard of care, the CardioMEMS HF System was cost-effective when leveraging trial data to populate the model. © 2017 Wiley Periodicals, Inc.

Temporary anchorage devices (TADs) in orthodontics: review of the factors that influence the clinical success rate of the mini-implants.

PubMed

Leo, M; Cerroni, L; Pasquantonio, G; Condò, S G; Condò, R

2016-01-01

The mini-implant, temporary anchorage devices (TADS), are now a common method of treatment in Orthodontics with versatility, minimal invasiveness and the relationship between costs and benefits that they offer even today. Skeletal anchorage has, to a large degree, replaced conventional anchorage in situations where anchorage is considered either critical, insufficient, or likely to result in undesirable side effects such as vertical displacements generated by inter-maxillary force systems. The objective of this study is to carry out a review about the factors that seem affect the success or failure rate of orthodontic mini-implants. A computerized literature review was performed by searching the MEDLINE database (Entrez PubMed, www.ncbi.nlm.nih.gov), Google Scholar, Scopus, Cochrane Central Register of Controlled Trials, Isi Web of Knowledge until March 2016 . The main subject heading "orthodontics" was combined with these keywords mini-implant, mini-screw, micro-implants, mini-implant success rate, mini-implant failure rate, skeletal anchorage, temporary anchorage device (TADS). In the selection process, abstracts were initially read independently by two researchers to identify potentially eligible full text papers which were then retrieved and assessed in order to decide on the final inclusion. The clinical success of orthodontic anchorage by mini-implants depends on the stability of the miniscrews used for fixation. For good stability, the application site must provide bone of good quantity and quality. We can reasonably assume that the stability of the anchorage of the mini-implants could be optimized by selecting a position with particular characteristics of quality and quantity of bone, in relation to cortical and total mandibular and jaw bone thickness. These expected informations are important because they indicates that the bone quality and quantity are significant when considering an implant placement site, but also that there are other confounding factors influencing the success rate.

Why Do Medial Unicompartmental Knee Arthroplasties Fail Today?

PubMed

van der List, Jelle P; Zuiderbaan, Hendrik A; Pearle, Andrew D

2016-05-01

Failure rates are higher in medial unicompartmental knee arthroplasty (UKA) than total knee arthroplasty. To improve these failure rates, it is important to understand why medial UKA fail. Because individual studies lack power to show failure modes, a systematic review was performed to assess medial UKA failure modes. Furthermore, we compared cohort studies with registry-based studies, early with midterm and late failures and fixed-bearing with mobile-bearing implants. Databases of PubMed, EMBASE, and Cochrane and annual registries were searched for medial UKA failures. Studies were included when they reported >25 failures or when they reported early (<5 years), midterm (5-10 years), or late failures (>10 years). Thirty-seven cohort studies (4 level II studies and 33 level III studies) and 2 registry-based studies were included. A total of 3967 overall failures, 388 time-dependent failures, and 1305 implant design failures were identified. Aseptic loosening (36%) and osteoarthritis (OA) progression (20%) were the most common failure modes. Aseptic loosening (26%) was most common early failure mode, whereas OA progression was more commonly seen in midterm and late failures (38% and 40%, respectively). Polyethylene wear (12%) and instability (12%) were more common in fixed-bearing implants, whereas pain (14%) and bearing dislocation (11%) were more common in mobile-bearing implants. This level III systematic review identified aseptic loosening and OA progression as the major failure modes. Aseptic loosening was the main failure mode in early years and mobile-bearing implants, whereas OA progression caused most failures in late years and fixed-bearing implants. Copyright © 2016 Elsevier Inc. All rights reserved.

Changes in implant stability using different site preparation techniques: twist drills versus piezosurgery. A single-blinded, randomized, controlled clinical trial.

PubMed

Stacchi, Claudio; Vercellotti, Tomaso; Torelli, Lucio; Furlan, Fabio; Di Lenarda, Roberto

2013-04-01

The objective of the present investigation was to longitudinally monitor stability changes of implants inserted using traditional rotary instruments or piezoelectric inserts, and to follow their variations during the first 90 days of healing. A randomized, controlled trial was conducted on 20 patients. Each patient received two identical, adjacent implants in the upper premolar area: the test site was prepared with piezosurgery, and the control site was prepared using twist drills. Resonance frequency analysis measurements were taken by a blinded operator on the day of surgery and after 7, 14, 21, 28, 42, 56, and 90 days. At 90 days, 39 out of 40 implants were osseointegrated (one failure in the control group). Both groups showed an initial decrease in mean implant stability quotient (ISQ) values: a shift in implant stability to increasing ISQ values occurred after 14 days in the test group and after 21 days in the control group. The lowest mean ISQ value was recorded at 14 days for test implants (97.3% of the primary stability) and at 21 days for the control implants (90.8% of the primary stability). ISQ variations with respect to primary stability differed significantly between the two groups during the entire period of observation: from day 14 to day 42, in particular, the differences were extremely significant (p < .0001). All 39 implants were in function successfully at the visit scheduled 1 year after insertion. The findings from this study suggest that ultrasonic implant site preparation results in a limited decrease of ISQ values and in an earlier shifting from a decreasing to an increasing stability pattern, when compared with the traditional drilling technique. From a clinical point of view, implants inserted with the piezoelectric technique demonstrated a short-term clinical success similar to those inserted using twist drills. © 2011 Wiley Periodicals, Inc.

One-Piece Zirconia Ceramic versus Titanium Implants in the Jaw and Femur of a Sheep Model: A Pilot Study.

PubMed

Siddiqi, A; Duncan, W J; De Silva, R K; Zafar, S

2016-01-01

Reports have documented titanium (Ti) hypersensitivity after dental implant treatment. Alternative materials have been suggested including zirconia (Zr) ceramics, which have shown predictable osseointegration in animal studies and appear free of immune responses. The aim of the research was to investigate the bone-to-implant contact (BIC) of one-piece Zr, compared with one-piece Ti implants, placed in the jaws and femurs of domestic sheep. Ten New Zealand mixed breed sheep were used. A One-piece prototype Ti (control) and one Zr (test) implant were placed in the mandible, and one of each implant (Ti and Zr) was placed into the femoral epicondyle of each animal. The femur implants were submerged and unloaded; the mandibular implants were placed using a one-stage transgingival protocol and were nonsubmerged. After a healing period of 12 weeks, %BIC was measured. The overall survival rate for mandibular and femur implants combined was 87.5%. %BIC was higher for Zr implants versus Ti implants in the femur (85.5%, versus 78.9%) ( p = 0.002). Zirconia implants in the mandible showed comparable %BIC to titanium implants (72.2%, versus 60.3%) ( p = 0.087). High failure rate of both Zr and Ti one-piece implants in the jaw could be attributed to the one-piece design and surface characteristics of the implant that could have influenced osseointegration. Further clinical trials are recommended to evaluate the performance of zirconia implants under loading conditions.

One-Piece Zirconia Ceramic versus Titanium Implants in the Jaw and Femur of a Sheep Model: A Pilot Study

PubMed Central

De Silva, R. K.; Zafar, S.

2016-01-01

Reports have documented titanium (Ti) hypersensitivity after dental implant treatment. Alternative materials have been suggested including zirconia (Zr) ceramics, which have shown predictable osseointegration in animal studies and appear free of immune responses. The aim of the research was to investigate the bone-to-implant contact (BIC) of one-piece Zr, compared with one-piece Ti implants, placed in the jaws and femurs of domestic sheep. Ten New Zealand mixed breed sheep were used. A One-piece prototype Ti (control) and one Zr (test) implant were placed in the mandible, and one of each implant (Ti and Zr) was placed into the femoral epicondyle of each animal. The femur implants were submerged and unloaded; the mandibular implants were placed using a one-stage transgingival protocol and were nonsubmerged. After a healing period of 12 weeks, %BIC was measured. The overall survival rate for mandibular and femur implants combined was 87.5%. %BIC was higher for Zr implants versus Ti implants in the femur (85.5%, versus 78.9%) (p = 0.002). Zirconia implants in the mandible showed comparable %BIC to titanium implants (72.2%, versus 60.3%) (p = 0.087). High failure rate of both Zr and Ti one-piece implants in the jaw could be attributed to the one-piece design and surface characteristics of the implant that could have influenced osseointegration. Further clinical trials are recommended to evaluate the performance of zirconia implants under loading conditions. PMID:28058261

Influence of bisphosphonates on alveolar bone loss around osseointegrated implants.

PubMed

Zahid, Talal M; Wang, Bing-Yan; Cohen, Robert E

2011-06-01

The relationship between bisphosphonates (BP) and dental implant failure has not been fully elucidated. The purpose of this retrospective radiographic study was to examine whether patients who take BP are at greater risk of implant failure than patients not using those agents. Treatment records of 362 consecutively treated patients receiving endosseous dental implants were reviewed. The patient population consisted of 227 women and 135 men with a mean age of 56 years (range: 17-87 years), treated in the University at Buffalo Postgraduate Clinic from 1997-2008. Demographic information collected included age, gender, smoking status, as well as systemic conditions and medication use. Implant characteristics reviewed included system, date of placement, date of follow-up radiographs, surgical complications, number of exposed threads, and implant failure. The relationship between BP and implant failure was analyzed using generalized estimating equation (GEE) analysis. Twenty-six patients using BP received a total of 51 dental implants. Three implants failed, yielding success rates of 94.11% and 88.46% for the implant-based and subject-based analyses, respectively. Using the GEE statistical method we found a statistically significant (P  =  .001; OR  =  3.25) association between the use of BP and implant thread exposure. None of the other variables studied were statistically associated with implant failure or thread exposure. In conclusion, patients taking BP may be at higher risk for implant thread exposure.

Study design of the influence of SErotonin inhibition on patients with RENAl impairment or diabetes undergoing drug-eluting stent implantation (SERENADE) study: A multicenter, open-label, prospective, randomized study.

PubMed

Lee, Seung-Ah; Suh, Jung-Won; Park, Jin Joo; Yoon, Chang-Hwan; Cho, Young-Suk; Youn, Tae-Jin; Chae, In-Ho; Kim, Hyo-Soo; Kim, Sang-Hyun; Choi, Dong-Ju

2015-07-01

The rates of stent failure after percutaneous coronary intervention have decreased since the introduction of the drug-eluting stent (DES). However, chronic kidney disease (CKD) and diabetes mellitus (DM) remain strong clinical predictors of poor prognosis despite DES implantation. Sarpogrelate, a selective serotonin (5-hydroxytryptamine (HT)2a [5-HT2A]) receptor antagonist, has antiproliferative effects, reducing neointimal hyperplasia and smooth muscle cell proliferation, as well as potent antiplatelet action, inhibiting 5-HT-induced platelet aggregation. However, efficacy and safety data for sarpogrelate in patients with CKD or DM are limited. We aim to determine whether sarpogrelate has beneficial effects in patients with CDK or DM treated with DES implantation. The SERENADE trial is a multicenter, open-label, prospective, randomized study that will test the superiority of triple anti-platelet therapy (TAT; aspirin, clopidogrel, and sarpogrelate) to conventional dual antiplatelet therapy (DAT; aspirin and clopidogrel) in preventing late lumen loss 9 months after the index procedure in patients with CKD or DM. A total of 220 patients diagnosed with coronary artery disease with DM or CKD will be randomized to the TAT or DAT groups (1:1 ratio) after DES implantation. The primary endpoint is late lumen loss at 9 months assessed by quantitative coronary angiography. Secondary efficacy endpoints are composites of major adverse cardiovascular events including cardiac death, nonfatal myocardial infarction, and target lesion revascularization. Secondary safety endpoints are major bleeding events and hepatic or renal impairment. The SERENADE trial will provide insight on the efficacy of adjunctive therapy with sarpogrelate after DES implantation for patients with high-risk profiles such as CKD or DM. National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov NCT02294643). Copyright © 2015. Published by Elsevier Inc.

The Failure Envelope Concept Applied To The Bone-Dental Implant System.

PubMed

Korabi, R; Shemtov-Yona, K; Dorogoy, A; Rittel, D

2017-05-17

Dental implants interact with the jawbone through their common interface. While the implant is an inert structure, the jawbone is a living one that reacts to mechanical stimuli. Setting aside mechanical failure considerations of the implant, the bone is the main component to be addressed. With most failure criteria being expressed in terms of stress or strain values, their fulfillment can mean structural flow or fracture. However, in addition to those effects, the bony structure is likely to react biologically to the applied loads by dissolution or remodeling, so that additional (strain-based) criteria must be taken into account. While the literature abounds in studies of particular loading configurations, e.g. angle and value of the applied load to the implant, a general study of the admissible implant loads is still missing. This paper introduces the concept of failure envelopes for the dental implant-jawbone system, thereby defining admissible combinations of vertical and lateral loads for various failure criteria of the jawbone. Those envelopes are compared in terms of conservatism, thereby providing a systematic comparison of the various failure criteria and their determination of the admissible loads.

Analysis of the Factors Affecting Surgical Success of Implants Placed in Iranian Warfare Victims

PubMed Central

Jafarian, Mohammad; Bayat, Mohammad; Pakravan, Amir-Hossein; Emadi, Naghmeh

2016-01-01

Objective The aim was to evaluate the survival time and success rates of dental implants in warfare victims and factors that affect implant success. Subjects and Methods This retrospective study involved 250 Iranian warfare victims who received dental implants from 2003 to 2013. Patients' demographic characteristics, as well as the brand, diameter, length, location and failure rate of the implants were retrieved from patients' dental records and radiographs. The associations between these data and the survival rate were analyzed. Statistical analysis was carried out with χ2 and log-rank tests. Results Overall, out of the 1,533 dental implants, 61 (4s%) failed. The maxillary canine area had the highest failure rate [9 of 132 implants (6.8s%)], while the mandibular incisor region had the least number of failures [3 of 147 implants (2.0s%)] and the longest survival time (approximately 3,182 days). Maxillary canine areas had the shortest survival (about 2,996 days). The longest survival time was observed in implants with 11 mm length (3,179.72 ± 30.139 days) and 3.75-4 mm diameter (3,131.161 ± 35.96 days), and the shortest survival was found in implants with 11.5 mm length (2,317.79 ± 18.71 days) and 6.5 mm diameter (2,241.45 ± 182.21 days). Moreover, implants with 10 mm length (10.7s%) and 5.5-6 mm diameter (22.2s%) had the highest failure rate; however, the least failure rate occurred when the implants were 11.5 mm in length (1.9s%) and 3-3.5 mm in diameter (3.1s%). Conclusions The brand, length and diameter of implants affected the survival time, failure rate and time to failure. The location of the implant was not statistically significant regarding the mentioned factors, although it has clinical significance. PMID:27322534

Polymorphisms of Il-10 (-1082) and RANKL (-438) Genes and the Failure of Dental Implants

PubMed Central

Ribeiro, Rodrigo; Melo, Rayanne; Tortamano Neto, Pedro; Vajgel, André

2017-01-01

Background. Genetic polymorphisms in certain cytokines and chemokines have been investigated to understand why some individuals display implant flaws despite having few risk factors at the time of implant. Purpose. To investigate the association of genetic polymorphisms in interleukin- (IL-) 10 [-1082 region (A/G)] and RANKL [-438 region (A/G)] with the failure of dental implants. Materials and Methods. This study included 90 partially edentulous male and female patients who were rehabilitated with a total of 245 Straumann dental implants. An implant was considered a failure if any of the following occurred: mobility, persistent subjective complaint, recurrent peri-implant infection with suppuration, continuous radiolucency around the implant, probing depth ≥ 5 mm, and bleeding on probing. Buccal mucosal cells were collected for analysis of RANKL438 and IL-10. Results. The implant success rate in this population was 34.4%. The mutant allele (G) in RANKL had an incidence of 52.3% and mutant allele (A) in IL-10 was observed in 37.8%. No statistically significant difference was detected between the failure of the implant and the genotypes and allelic frequencies. Conclusion. No association was detected between the genetic polymorphisms of RANKL (-438) and IL-10 (-1082) and the failure of dental implants in the population studied. PMID:28348592

Polymorphisms of Il-10 (-1082) and RANKL (-438) Genes and the Failure of Dental Implants.

PubMed

Ribeiro, Rodrigo; Melo, Rayanne; Tortamano Neto, Pedro; Vajgel, André; Souza, Paulo Roberto Eleutério; Cimões, Renata

2017-01-01

Background . Genetic polymorphisms in certain cytokines and chemokines have been investigated to understand why some individuals display implant flaws despite having few risk factors at the time of implant. Purpose . To investigate the association of genetic polymorphisms in interleukin- (IL-) 10 [-1082 region (A/G)] and RANKL [-438 region (A/G)] with the failure of dental implants. Materials and Methods . This study included 90 partially edentulous male and female patients who were rehabilitated with a total of 245 Straumann dental implants. An implant was considered a failure if any of the following occurred: mobility, persistent subjective complaint, recurrent peri-implant infection with suppuration, continuous radiolucency around the implant, probing depth ≥ 5 mm, and bleeding on probing. Buccal mucosal cells were collected for analysis of RANKL438 and IL-10 . Results . The implant success rate in this population was 34.4%. The mutant allele (G) in RANKL had an incidence of 52.3% and mutant allele (A) in IL-10 was observed in 37.8%. No statistically significant difference was detected between the failure of the implant and the genotypes and allelic frequencies. Conclusion . No association was detected between the genetic polymorphisms of RANKL (-438) and IL-10 (-1082) and the failure of dental implants in the population studied.

Tardive Dyskinesia, Oral Parafunction, and Implant-Supported Rehabilitation.

PubMed

Lumetti, S; Ghiacci, G; Macaluso, G M; Amore, M; Galli, C; Calciolari, E; Manfredi, E

2016-01-01

Oral movement disorders may lead to prosthesis and implant failure due to excessive loading. We report on an edentulous patient suffering from drug-induced tardive dyskinesia (TD) and oral parafunction (OP) rehabilitated with implant-supported screw-retained prostheses. The frequency and intensity of the movements were high, and no pharmacological intervention was possible. Moreover, the patient refused night-time splint therapy. A series of implant and prosthetic failures were experienced. Implant failures were all in the maxilla and stopped when a rigid titanium structure was placed to connect implants. Ad hoc designed studies are desirable to elucidate the mutual influence between oral movement disorders and implant-supported rehabilitation.

Tardive Dyskinesia, Oral Parafunction, and Implant-Supported Rehabilitation

PubMed Central

Amore, M.

2016-01-01

Oral movement disorders may lead to prosthesis and implant failure due to excessive loading. We report on an edentulous patient suffering from drug-induced tardive dyskinesia (TD) and oral parafunction (OP) rehabilitated with implant-supported screw-retained prostheses. The frequency and intensity of the movements were high, and no pharmacological intervention was possible. Moreover, the patient refused night-time splint therapy. A series of implant and prosthetic failures were experienced. Implant failures were all in the maxilla and stopped when a rigid titanium structure was placed to connect implants. Ad hoc designed studies are desirable to elucidate the mutual influence between oral movement disorders and implant-supported rehabilitation. PMID:28050290

Factors associated with dental implant survival: a 4-year retrospective analysis.

PubMed

Zupnik, Jamie; Kim, Soo-woo; Ravens, Daniel; Karimbux, Nadeem; Guze, Kevin

2011-10-01

Dental implants are a predictable treatment option for replacing missing teeth and have strong survival and success outcomes. However, previous research showed a wide array of potential risk factors that may have contributed to dental implant failures. The objectives of this study are to study if implant survival rates were affected by known risk factors and risk indicators that may have contributed to implant failures. The secondary outcome measures were whether the level of expertise of the periodontal residents affected success rates and how the rate of implant success at the Harvard School of Dental Medicine (HSDM) compared to published standards. A retrospective chart review of patients at the HSDM who had one of two types of rough-surface implants (group A or B) placed by periodontology residents from 2003 to 2006 was performed. Demographic, health, and implant data were collected and analyzed by multimodel analyses to determine failure rates and any factors that may have increased the likelihood of an implant failure. The study cohort included 341 dental implants. The odds ratio for an implant failure was most clearly elevated for diabetes (2.59 implant surface group B (7.84), and male groups (4.01). There was no significant difference regarding the resident experience. The success rate for HSDM periodontology residents was 96.48% during the 4-year study period. This study demonstrates that implant success rates at HSDM fell within accepted published standards, confirmed previously identified risk factors for a failure, and potentially suggested that other acknowledged risk factors could be controlled for. Furthermore, the level of experience of the periodontology resident did not have an impact on survival outcomes.

Impact of Different Surgeons on Dental Implant Failure.

PubMed

Chrcanovic, Bruno Ramos; Kisch, Jenö; Albrektsson, Tomas; Wennerberg, Ann

To assess the influence of several factors on the prevalence of dental implant failure, with special consideration of the placement of implants by different dental surgeons. This retrospective study is based on 2,670 patients who received 10,096 implants at one specialist clinic. Only the data of patients and implants treated by surgeons who had inserted a minimum of 200 implants at the clinic were included. Kaplan-Meier curves were stratified with respect to the individual surgeon. A generalized estimating equation (GEE) method was used to account for the fact that repeated observations (several implants) were placed in a single patient. The factors bone quantity, bone quality, implant location, implant surface, and implant system were analyzed with descriptive statistics separately for each individual surgeon. A total of 10 surgeons were eligible. The differences between the survival curves of each individual were statistically significant. The multivariate GEE model showed the following variables to be statistically significant: surgeon, bruxism, intake of antidepressants, location, implant length, and implant system. The surgeon with the highest absolute number of failures was also the one who inserted the most implants in sites of poor bone and used turned implants in most cases, whereas the surgeon with the lowest absolute number of failures used mainly modern implants. Separate survival analyses of turned and modern implants stratified for the individual surgeon showed statistically significant differences in cumulative survival. Different levels of failure incidence could be observed between the surgeons, occasionally reaching significant levels. Although a direct causal relationship could not be ascertained, the results of the present study suggest that the surgeons' technique, skills, and/or judgment may negatively influence implant survival rates.

Implication of sperm chromosomal abnormalities in recurrent abortion and multiple implantation failure.

PubMed

Caseiro, Ana Lara; Regalo, Ana; Pereira, Elisa; Esteves, Telma; Fernandes, Fernando; Carvalho, Joaquim

2015-10-01

Currently, some infertility treatment centres provide sperm karyotype analysis, although the impact of sperm chromosomal abnormalities on fertility is not yet fully understood. Several studies using fluorescence in-situ hybridization (FISH) to analyse sperm chromosomal constitution discovered that the incidence of aneuploidy is increased in individuals with a history of repeated abortion or implantation failure and is even higher in cases of oligoasthenoteratozoospermia (OAT), abnormal somatic karyotype or in spermatozoa retrieved directly from the testis or epididymis, showing that the application of FISH in these cases may be of some benefit for improving the reproductive outcome. This article presents the results of clinical trials of FISH analysis on spermatozoa, the medical indications for performing this examination, its results in infertile patients and the advantages when performing genetic counselling prior to treatment. Also discussed is the possibility of applying the latest techniques of genetic analysis in these cases and the potential benefits for improving the prognosis of male infertility. Copyright © 2015 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

Remote monitoring reduces healthcare use and improves quality of care in heart failure patients with implantable defibrillators: the evolution of management strategies of heart failure patients with implantable defibrillators (EVOLVO) study.

PubMed

Landolina, Maurizio; Perego, Giovanni B; Lunati, Maurizio; Curnis, Antonio; Guenzati, Giuseppe; Vicentini, Alessandro; Parati, Gianfranco; Borghi, Gabriella; Zanaboni, Paolo; Valsecchi, Sergio; Marzegalli, Maurizio

2012-06-19

Heart failure patients with implantable cardioverter-defibrillators (ICDs) or an ICD for resynchronization therapy often visit the hospital for unscheduled examinations, placing a great burden on healthcare providers. We hypothesized that Internet-based remote interrogation systems could reduce emergency healthcare visits. This multicenter randomized trial involving 200 patients compared remote monitoring with standard patient management consisting of scheduled visits and patient response to audible ICD alerts. The primary end point was the rate of emergency department or urgent in-office visits for heart failure, arrhythmias, or ICD-related events. Over 16 months, such visits were 35% less frequent in the remote arm (75 versus 117; incidence density, 0.59 versus 0.93 events per year; P=0.005). A 21% difference was observed in the rates of total healthcare visits for heart failure, arrhythmias, or ICD-related events (4.40 versus 5.74 events per year; P<0.001). The time from an ICD alert condition to review of the data was reduced from 24.8 days in the standard arm to 1.4 days in the remote arm (P<0.001). The patients' clinical status, as measured by the Clinical Composite Score, was similar in the 2 groups, whereas a more favorable change in quality of life (Minnesota Living With Heart Failure Questionnaire) was observed from the baseline to the 16th month in the remote arm (P=0.026). Remote monitoring reduces emergency department/urgent in-office visits and, in general, total healthcare use in patients with ICD or defibrillators for resynchronization therapy. Compared with standard follow-up through in-office visits and audible ICD alerts, remote monitoring results in increased efficiency for healthcare providers and improved quality of care for patients. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00873899.

A randomized controlled trial to evaluate the safety and efficacy of cardiac contractility modulation in patients with systolic heart failure: rationale, design, and baseline patient characteristics.

PubMed

Abraham, William T; Burkhoff, Daniel; Nademanee, Koonlawee; Carson, Peter; Bourge, Robert; Ellenbogen, Kenneth A; Parides, Michael; Kadish, Alan

2008-10-01

Cardiac contractility modulation (CCM) signals are nonexcitatory electrical signals delivered during the cardiac absolute refractory period that enhance the strength of cardiac muscular contraction. Prior research in experimental and human heart failure has shown that CCM signals normalize phosphorylation of key proteins and expression of genes coding for proteins involved in regulation of calcium cycling and contraction. The results of prior clinical studies of CCM have supported its safety and efficacy. A large-scale clinical study, the FIX-HF-5 study, is currently underway to test the safety and efficacy of this treatment. In this article, we provide an overview of the system used to deliver CCM signals, the implant procedure, and the details and rationale of the FIX-HF-5 study design. Baseline characteristics for patients randomized in this trial are also presented.

Routine implantation of cardioverter/defibrillator devices in patients aged 75 years and older with prior myocardial infarction and left ventricular ejection fraction < 30: antagonist viewpoint.

PubMed

Basta, Lofty L

2003-01-01

The Multicenter Automatic Defibrillator Implantation Trial (MADIT II) investigators assert that their results justify the placement of artificial implantable defibrillator cardioverter devices in patients aged 75 years and older with prior myocardial infarction and left ventricular dysfunction (ejection fraction of 30 or less). The authors claim that the results of the trial do not justify this conclusion. The majority of patients were male (84%) and aged 64+/-10 years. Also, 2.8% of patients assigned to the defibrillator group and 1.5% had their device removed. Of the latter subgroup, nine patients (1.3%) received a heart transplant. Twelve had their artificial implantable defibrillator cardioverter device deactivated mostly because of terminal illness. Although the study results show a significant reduction in mortality over the control group (absolute reduction=5.6%), almost the same percentage required hospitalization because of manifestation of congestive heart failure (absolute value 5%; p=0.09). Also, 1.8% had lead problems, 0.7% had infections, and the benefits were only seen after the first year. Caution is needed before the results of this study are applied to a much older cohort comprised mainly of women in whom heart transplant is contraindicated and who have multiple health problems, including cognitive impairment. Artificial implantable cardioverter/defibrillator devices are expensive and this study's results need to be duplicated in other comparable cohorts.

Can the Seattle heart failure model be used to risk-stratify heart failure patients for potential left ventricular assist device therapy?

PubMed

Levy, Wayne C; Mozaffarian, Dariush; Linker, David T; Farrar, David J; Miller, Leslie W

2009-03-01

According to results of the REMATCH trial, left ventricular assist device therapy in patients with severe heart failure has resulted in a 48% reduction in mortality. A decision tool will be necessary to aid in the selection of patients for destination left ventricular assist devices (LVADs) as the technology progresses for implantation in ambulatory Stage D heart failure patients. The purpose of this analysis was to determine whether the Seattle Heart Failure Model (SHFM) can be used to risk-stratify heart failure patients for potential LVAD therapy. The SHFM was applied to REMATCH patients with the prospective addition of inotropic agents and intra-aortic balloon pump (IABP) +/- ventilator. The SHFM was highly predictive of survival (p = 0.0004). One-year SHFM-predicted survival was similar to actual survival for both the REMATCH medical (30% vs 28%) and LVAD (49% vs 52%) groups. The estimated 1-year survival with medical therapy for patients in REMATCH was 30 +/- 21%, but with a range of 0% to 74%. The 1- and 2-year estimated survival was

Machine Learning Algorithm Predicts Cardiac Resynchronization Therapy Outcomes: Lessons From the COMPANION Trial.

PubMed

Kalscheur, Matthew M; Kipp, Ryan T; Tattersall, Matthew C; Mei, Chaoqun; Buhr, Kevin A; DeMets, David L; Field, Michael E; Eckhardt, Lee L; Page, C David

2018-01-01

Cardiac resynchronization therapy (CRT) reduces morbidity and mortality in heart failure patients with reduced left ventricular function and intraventricular conduction delay. However, individual outcomes vary significantly. This study sought to use a machine learning algorithm to develop a model to predict outcomes after CRT. Models were developed with machine learning algorithms to predict all-cause mortality or heart failure hospitalization at 12 months post-CRT in the COMPANION trial (Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure). The best performing model was developed with the random forest algorithm. The ability of this model to predict all-cause mortality or heart failure hospitalization and all-cause mortality alone was compared with discrimination obtained using a combination of bundle branch block morphology and QRS duration. In the 595 patients with CRT-defibrillator in the COMPANION trial, 105 deaths occurred (median follow-up, 15.7 months). The survival difference across subgroups differentiated by bundle branch block morphology and QRS duration did not reach significance ( P =0.08). The random forest model produced quartiles of patients with an 8-fold difference in survival between those with the highest and lowest predicted probability for events (hazard ratio, 7.96; P <0.0001). The model also discriminated the risk of the composite end point of all-cause mortality or heart failure hospitalization better than subgroups based on bundle branch block morphology and QRS duration. In the COMPANION trial, a machine learning algorithm produced a model that predicted clinical outcomes after CRT. Applied before device implant, this model may better differentiate outcomes over current clinical discriminators and improve shared decision-making with patients. © 2018 American Heart Association, Inc.

Implant failure in lower limb long bone diaphyseal fractures at a tertiary hospital in Ile- Ife. Nigeria.

PubMed

Esan, O; Ikem, I C; Orimolade, E A; Esan, O T

2014-06-01

This included determining aetiology of failure and comparing the failure rate in implant fixations using solid intramedullary nail and DCP. A retrospective study conducted at the Orthopaedic Department, Obafemi Awolowo University Teaching Hospital, Ile-Ife,Nigeria. Records of all operated cases of lower limb long bone diaphyseal fractures including those with failed fixations from August 2006-July 2011 were reviewed. Data retrieved included type of implant used, aetiology and characteristics of Implant failure. Data were analysed using SPSS version 16. Frequency distribution of the variables of interest was done. Difference in failure rate of intramedullary nail versus DCP was tested using chi-square. Statistical significance was inferred at p<0.05. A total of 280 patients were studied out of which two hundred and twenty-one patients had long bone diaphyseal fractures and met inclusion criteria, of which 135 had intramedullary nail fixation and 86 had DCP. The rate of implant failure in intramedullary nail was 1.5% while it was 5.8% in patients with DCP (p=0.113; 0R=4.10; 95% CI=0.65- 43.77). Implant fracture was the commonest type of failure seen (100% versus 60%) and non union was the commonest cause of failure seen (50% versus 40%) in the intramedullary nailing and DCP groups respectively. The likelihood of a failed implant is higher in fixations done with DCP compared with intramedullary nail though the difference was not statistically significant. Commonest reason for failure in both groups was non-union. Findings from this study may guide surgeons in choice of implant in the management of long bone fractures.

Alveolar Ridge Reconstruction with Titanium Meshes and Simultaneous Implant Placement: A Retrospective, Multicenter Clinical Study

PubMed Central

Paraud Freixas, Andres; Han, Chang-Hun; Bechara, Sohueil; Tawil, Isaac

2016-01-01

Objective. To evaluate horizontal bone gain and implant survival and complication rates in patients treated with titanium meshes placed simultaneously with dental implants and fixed over them. Methods. Twenty-five patients treated with 40 implants and simultaneous guided bone regeneration with titanium meshes (i–Gen®, MegaGen, Gyeongbuk, Republic of Korea) were selected for inclusion in the present retrospective multicenter study. Primary outcomes were horizontal bone gain and implant survival; secondary outcomes were biological and prosthetic complications. Results. After the removal of titanium meshes, the CBCT evaluation revealed a mean horizontal bone gain of 3.67 mm (±0.89). The most frequent complications were mild postoperative edema (12/25 patients: 48%) and discomfort after surgery (10/25 patients: 40%); these complications were resolved within one week. Titanium mesh exposure occurred in 6 patients (6/25 : 24%): one of these suffered partial loss of the graft and another experienced complete graft loss and implant failure. An implant survival rate of 97.5% (implant-based) and a peri-implant marginal bone loss of 0.43 mm (±0.15) were recorded after 1 year. Conclusions. The horizontal ridge reconstruction with titanium meshes placed simultaneously with dental implants achieved predictable satisfactory results. Prospective randomized controlled trials on a larger sample of patients are required to validate these positive outcomes. PMID:27999799

The role of dental implant abutment design on the aesthetic outcome: preliminary 3-month post-loading results from a multicentre split-mouth randomised controlled trial comparing two different abutment designs.

PubMed

Esposito, Marco; Cardaropoli, Daniele; Gobbato, Luca; Scutellà, Fabio; Fabianelli, Andrea; Mascellani, Saverio; Delli Ficorelli, Gianluca; Mazzocco, Fabio; Sbricoli, Luca; Trullenque-Eriksson, Anna

To evaluate whether there are aesthetic and clinical benefits to using a newly designed abutment (Curvomax), over a conventional control abutment (GingiHue). A total of 49 patients, who required at least two implants, had two sites randomised according to a split-mouth design to receive one abutment of each type at seven different centres. The time of loading (immediate, early or delayed) and of prosthesis (provisional crowns of fixed prosthesis) was decided by the clinicians, but they had to restore both implants in a similar way. Provisional prostheses were replaced by definitive ones 3 months after initial loading, when the follow-up for the initial part of this study was completed. Outcome measures were: prosthesis failures, implant failures, complications, pink esthetic score (PES), peri-implant marginal bone level changes, and patient preference. In total, 49 Curvomax and 49 GingiHue abutments were delivered. Two patients dropped out. No implant failure, prosthesis failure or complication was reported. There were no differences at 3 months post-loading for PES (difference = -0.15, 95% CI -0.55 to 0.25; P (paired t test) = 0.443) and marginal bone level changes (difference = -0.02 mm, 95% CI -0.20 to 0.16; P (paired t test) = 0.817). The majority of the patients (30) had no preference regarding the two abutment designs; 11 patients preferred the Curvomax, while five patients preferred the GingiHue abutments (P (McNemar test) = 0.210). The preliminary results of the comparison between two different abutment designs did not disclose any statistically significant differences between the evaluated abutments. However the large number of missing radiographs and clinical pictures casts doubt on the reliability of the results. Longer follow-ups of wider patient populations are needed to better understand whether there is an effective advantage with one of the two abutment designs. Conflict of interest statement: This research project was originally partially funded by Biomax (Andover, MA, USA), the manufacturer of the Curvomax abutments evaluated in this investigation. Biomax, under pressure from some investigators, asked to modify the original agreed protocol. In a following phase, Zimmer-Biomet (Palm Beach Gardens, Florida, USA), the manufacturer of the implants and the GingiHue abutments, took over the funding of this project. Data belonged to the authors and the sponsors did not interfere with the publication of results.

Rapid-rate nonsustained ventricular tachycardia found on implantable cardioverter-defibrillator interrogation: relationship to outcomes in the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial).

PubMed

Chen, Jay; Johnson, George; Hellkamp, Anne S; Anderson, Jill; Mark, Daniel B; Lee, Kerry L; Bardy, Gust H; Poole, Jeanne E

2013-05-28

The aim of this study was to examine rapid-rate nonsustained ventricular tachycardia (RR-NSVT) during routine implantable cardioverter-defibrillator (ICD) evaluation in patients with heart failure and its relationship to outcomes. The clinical implications of RR-NSVT identified during routine ICD interrogation are unclear. In this study, the occurrence of RR-NSVT and its association with ICD shocks and mortality in SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial) were examined. The 811 patients who received ICDs in SCD-HeFT constituted the study population. The occurrence of RR-NSVT and its association with ICD shocks and mortality in SCD-HeFT were examined. RR-NSVT was documented on ICD interrogation in 186 of 811 patients (22.9%). The mean duration of RR-NSVT was 26.4 ± 9.1 beats (7.5 ± 2.6 s), with a mean cycle length of 259 ± 32 ms. Polymorphic RR-NSVT accounted for 56% of episodes. Compared with patients without RR-NSVT, those with RR-NSVT were less likely to be taking beta-blockers, statins, or aspirin at enrollment. After adjusting for other known predictors of mortality in SCD-HeFT, RR-NSVT was independently associated with appropriate ICD shocks (hazard ratio: 4.25; 95% confidence interval: 2.94 to 6.14; p < 0.0001), with all-cause mortality (hazard ratio: 2.40; 95% confidence interval: 1.62 to 3.54; p < 0.0001), and with a composite of all-cause mortality and appropriate ICD shocks (hazard ratio: 3.03; 95% confidence interval: 2.21 to 4.15; p < 0.0001). RR-NSVT identified on routine ICD interrogation should be considered an important clinical event. RR-NSVT during ICD interrogation is associated with appropriate ICD shocks and all-cause mortality. The clinical evaluation of patients with RR-NSVT should include intensification of medical therapy, particularly beta-blockers, or other appropriate clinical interventions. (Sudden Cardiac Death in Heart Failure Trial [SCD-HeFT]; NCT00000609). Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Failure to Treat Life-Threatening Ventricular Tachyarrhythmias in Contemporary Implantable Cardioverter–Defibrillators

PubMed Central

Thøgersen, Anna Margrethe; Larsen, Jacob Moesgaard; Johansen, Jens Brock; Abedin, Moeen

2017-01-01

Background: In clinical trials, manufacturer-specific, strategic programming of implantable cardioverter–defibrillators (ICDs), including faster detection rates, reduces unnecessary therapy but permits therapy for ventricular tachycardia/ventricular fibrillation (VF). Present consensus recommends a generic rate threshold between 185 and 200 beats per minute, which exceeds the rate tested in clinical trials for some manufacturers. In a case series, we sought to determine the relationship between programmed parameters and failure of modern ICDs to treat VF. Methods and Results: We reviewed cases in which normally functioning ICDs failed to deliver timely therapy for VF from April 2015 to January 2017 at 4 institutions. Of 10 ambulatory patients, 5 died from untreated VF, 4 had cardiac arrests requiring external shocks, and 1 was rescued by a delayed ICD shock. VF did not satisfy programmed detection criteria in 9 patients (90%). Seven of these patients had slowest detection rates that were consistent with generic recommendations but not tested in a peer-reviewed trial for their manufacturer’s ICDs. Manufacturer-specific factors interacted with fast detection rates to withhold therapy, including strict VF episode termination rules, enhancements to minimize T-wave oversensing, and features that restrict therapy to regular rhythms in ventricular tachycardia zones. Untreated VF despite recommended programming accounted for 56% of sudden deaths and 11% of all deaths during the study period. Conclusions: Complex and unanticipated interactions between manufacturer-specific features and generic programming can prevent therapy for VF. More data are needed to assess the risks and benefits of translating evidence-based detection parameters from one manufacturer to another. PMID:28916511

Esthetic and Clinical Performance of Implant-Supported All-Ceramic Crowns Made with Prefabricated or CAD/CAM Zirconia Abutments: A Randomized, Multicenter Clinical Trial.

PubMed

Wittneben, J G; Gavric, J; Belser, U C; Bornstein, M M; Joda, T; Chappuis, V; Sailer, I; Brägger, U

2017-02-01

Patients' esthetic expectations are increasing, and the options of the prosthetic pathways are currently evolving. The objective of this randomized multicenter clinical trial was to assess and compare the esthetic outcome and clinical performance of anterior maxillary all-ceramic implant crowns (ICs) based either on prefabricated zirconia abutments veneered with pressed ceramics or on CAD/CAM zirconia abutments veneered with hand buildup technique. The null hypothesis was that there is no statistically significant difference between the 2 groups. Forty implants were inserted in sites 14 to 24 (FDI) in 40 patients in 2 centers, the Universities of Bern and Geneva, Switzerland. After final impression, 20 patients were randomized into group A, restored with a 1-piece screw-retained single crown made of a prefabricated zirconia abutment with pressed ceramic as the veneering material using the cut-back technique, or group B using an individualized CAD/CAM zirconia abutment (CARES abutment; Institut Straumann AG) with a hand buildup technique. At baseline, 6 mo, and 1 y clinical, esthetic and radiographic parameters were assessed. Group A exhibited 1 dropout patient and 1 failure, resulting in a survival rate of 94.7% after 1 y, in comparison to 100% for group B. No other complications occurred. Clinical parameters presented stable and healthy peri-implant soft tissues. Overall, no or only minimal crestal bone changes were observed with a mean DIB (distance from the implant shoulder to the first bone-to-implant contact) of -0.15 mm (group A) and 0.12 mm (group B) at 1 y. There were no significant differences at baseline, 6 mo, and 1 y for DIB values between the 2 groups. Pink esthetic score (PES) and white esthetic score (WES) values at all 3 examinations indicated stability over time for both groups and pleasing esthetic outcomes. Both implant-supported prosthetic pathways represent a valuable treatment option for the restoration of single ICs in the anterior maxilla ( ClinicalTrials.gov NCT02905838).

Technical complications of implant-causes and management: A comprehensive review

PubMed Central

Gupta, Swati; Gupta, Hemant; Tandan, Amrit

2015-01-01

Given the increasing popularity of dental implants, the number of failures due to late implant fracture is also expected to increase. Hence, the scope for prevention and management needs to be emphasized. The objective of this review article is to analyze the various causes of failure of dental implants due to implant fixture/abutment screw fractures and also to enumerate the management and the preventive options for these failures, thereby aiming to help the clinicians to properly plan the implant-supported prosthesis treatment by considering the important biomechanical aspects of this type of rehabilitation. The present review emphasizes the causes and management of technical complications and not the incidence of such complications. PMID:26668445

The Significance of Shocks in Implantable Cardioverter Defibrillator Recipients

PubMed Central

Li, Anthony; Kaura, Amit; Sunderland, Nicholas; Dhillon, Paramdeep S

2016-01-01

Large-scale implantable cardioverter defibrillator (ICD) trials have unequivocally shown a reduction in mortality in appropriately selected patients with heart failure and depressed left ventricular function. However, there is a strong association between shocks and increased mortality in ICD recipients. It is unclear if shocks are merely a marker of a more severe cardiovascular disease or directly contribute to the increase in mortality. The aim of this review is to examine the relationship between ICD shocks and mortality, and explore possible mechanisms. Data examining the effect of shocks in the absence of spontaneous arrhythmias as well as studies of non-shock therapy and strategies to reduce shocks are analysed to try and disentangle the shocks versus substrate debate. PMID:27617089

Development of high impedance measurement system for water leakage detection in implantable neuroprosthetic devices.

PubMed

Yousif, Aziz; Kelly, Shawn K

2016-08-01

There has been a push for a greater number of channels in implantable neuroprosthetic devices; but, that number has largely been limited by current hermetic packaging technology. Microfabricated packaging is becoming reality, but a standard testing system is needed to prepare these devices for clinical trials. Impedance measurements of electrodes built into the packaging layers may give an early warning of device failure and predict device lifetime. Because the impedance magnitudes of such devices can be on the order of gigaohms, a versatile system was designed to accommodate ultra-high impedances and allow future integrated circuit implementation in current neural prosthetic technologies. Here we present the circuitry, control software, and preliminary testing results of our designed system.

Incidence, predictors, and procedural results of upgrade to resynchronization therapy: the RAFT upgrade substudy.

PubMed

Essebag, Vidal; Joza, Jacqueline; Birnie, David H; Sapp, John L; Sterns, Laurence D; Philippon, Francois; Yee, Raymond; Crystal, Eugene; Kus, Teresa; Rinne, Claus; Healey, Jeffrey S; Sami, Magdi; Thibault, Bernard; Exner, Derek V; Coutu, Benoit; Simpson, Chris S; Wulffhart, Zaev; Yetisir, Elizabeth; Wells, George; Tang, Anthony S L

2015-02-01

The resynchronization-defibrillation for ambulatory heart failure trial (RAFT) study demonstrated that adding cardiac resynchronization therapy (CRT) in selected patients requiring de novo implantable cardiac defibrillators (ICD) reduced mortality as compared with ICD therapy alone, despite an increase in procedure-related adverse events. Data are lacking regarding the management of patients with ICD therapy who develop an indication for CRT upgrade. Participating RAFT centers provided data regarding de novo CRT-D (CRT with ICD) implant, upgrade to CRT-D during RAFT (study upgrade), and upgrade within 6 months after presentation of study results (substudy). Substudy centers enrolled 1346 (74.9%) patients in RAFT, including 644 de novo, 80 study upgrade, and 60 substudy CRT attempts. The success rate (initial plus repeat attempts) was 95.2% for de novo versus 96.3% for study upgrade and 90.0% for substudy CRT attempts (P=0.402). Acute complications occurred among 26.2% of de novo versus 18.8% of study upgrade and 3.4% of substudy CRT implantation attempts (P<0.001). The most common complication was left ventricular lead dislodgement. The principal reasons for not yet attempting upgrade in the substudy were patient preference (31.9%), New York Heart Association Class I (17.0%), and a QRS<150 ms (13.1%). Among a broad group of implant physicians, CRT upgrades were performed in patients with an ICD in situ with no difference in implant success rate and a reduced acute complication rate as compared with a de novo CRT implant. Decisions to upgrade were influenced by predictors of benefit in subgroup analyses of the RAFT study and other trials. © 2014 American Heart Association, Inc.

Machined versus roughened immediately loaded and finally restored single implants inserted flapless: Preliminary 6-month data from a split- mouth randomised controlled trial.

PubMed

Cannizzaro, Gioacchino; Felice, Pietro; Loi, Ignazio; Viola, Paolo; Ferri, Vittorio; Leone, Michele; Lazzarini, Matteo; Trullenque-Eriksson, Anna; Esposito, Marco

To compare the outcome of immediately loaded single implants with a machined or a roughened surface. Fifty patients had two implant sites randomly allocated to receive flaplessplaced single Syra implants (Sweden & Martina), one with a machined and one with a roughened surface (sand-blasted with zirconia powder and acid etched), according to a split-mouth design. To be loaded immediately, implants had to be inserted with a torque superior to 50 Ncm. Implants were restored with definitive crowns in direct occlusal contact within 48 h. Patients were followed for 6 months after loading. Outcome measures were prosthetic and implant failures and complications. Two machined implants and four roughened implants were not loaded immediately. Six months after loading no dropout occurred. One implant loaded late, which had a rough implant surface, failed 20 days after loading (P (McNemar test) = 0.625; difference in proportions = -0.04; 95% CI: -0.15 to 0.07). Three crowns had to be remade on machined implants and four on roughened implants (P (McNemar test) = 1.000; difference in proportions = -0.02; 95% CI: -0.12 to 0.08). Three machined and five roughened implants experienced complications (P (McNemar test) = 0.625; difference in proportions = -0.04; 95% CI: -0.15 to 0.07). There were no statistically significant differences between groups for crown and implant losses as well as complications. Up to 6 months after loading both machined and roughened flapless-placed and immediately loaded single implants provided good and similar results, however, longer follow-ups are needed to evaluate the long-term prognosis of implants with different surfaces.

Short Dental Implants Retaining Two-Implant Mandibular Overdentures in Very Old, Dependent Patients: Radiologic and Clinical Observation Up to 5 Years.

PubMed

Maniewicz, Sabrina; Buser, Ramona; Duvernay, Elena; Vazquez, Lydia; Loup, Angelica; Perneger, Thomas V; Schimmel, Martin; Müller, Frauke

To describe the survival rate and peri-implant bone loss in very old patients dependent for their activities of daily living (ADL), treated with mandibular two-implant overdentures (IODs) in the context of a previously reported randomized controlled trial. A total of 19 patients received two interforaminal Straumann implants (Regular Neck, 4.1 mm diameter, 8 mm length) that were subsequently loaded with Locator attachments, transforming their preexisting inferior conventional denture into an IOD. The primary outcome measures were implant survival rate and radiographically assessed peri-implant bone loss. Secondary outcome measures included peri-implant probing depth and Plaque Index scores, as well as implant mobility. Nutritional state (body mass index and blood markers) and cognitive state (Mini-Mental State Examination) were also analyzed. The patient cohort comprised eight men and 11 women with a mean age of 85.7 ± 6.6 years. The implant survival rate up to 5 years was 94.7%, with one early and one late implant failure. The mean loss of peri-implant bone height was 0.17 mm per year (95% confidence interval: 0.09 to 0.24; P < .001). Peri-implant probing depth and Plaque Index scores were low and stable during the first 2 years, and thereafter increased continuously. Correlation analysis suggests that a reduced cognitive function and nutritional state are not a particular risk factor for accelerated peri-implant bone loss. The high implant survival and acceptable peri-implant health suggest that neither age nor dependency for the ADLs is a contraindication for the placement of implants. Nevertheless, close monitoring of the patients concerning a potential further functional decline precluding denture management and performing oral hygiene measures is advised.

On stress/strain shielding and the material stiffness paradigm for dental implants.

PubMed

Korabi, Raoof; Shemtov-Yona, Keren; Rittel, Daniel

2017-10-01

Stress shielding considerations suggest that the dental implant material's compliance should be matched to that of the host bone. However, this belief has not been confirmed from a general perspective, either clinically or numerically. To characterize the influence of the implant stiffness on its functionality using the failure envelope concept that examines all possible combinations of mechanical load and application angle for selected stress, strain and displacement-based bone failure criteria. Those criteria represent bone yielding, remodeling, and implant primary stability, respectively MATERIALS AND METHODS: We performed numerical simulations to generate failure envelopes for all possible loading configurations of dental implants, with stiffness ranging from very low (polymer) to extremely high, through that of bone, titanium, and ceramics. Irrespective of the failure criterion, stiffer implants allow for improved implant functionality. The latter reduces with increasing compliance, while the trabecular bone experiences higher strains, albeit of an overall small level. Micromotions remain quite small irrespective of the implant's stiffness. The current paradigm favoring reduced implant material's stiffness out of concern for stress or strain shielding, or even excessive micromotions, is not supported by the present calculations, that point exactly to the opposite. © 2017 Wiley Periodicals, Inc.

Implant experience with an implantable hemodynamic monitor for the management of symptomatic heart failure.

PubMed

Steinhaus, David; Reynolds, Dwight W; Gadler, Fredrik; Kay, G Neal; Hess, Mike F; Bennett, Tom

2005-08-01

Management of congestive heart failure is a serious public health problem. The use of implantable hemodynamic monitors (IHMs) may assist in this management by providing continuous ambulatory filling pressure status for optimal volume management. The Chronicle system includes an implanted monitor, a pressure sensor lead with passive fixation, an external pressure reference (EPR), and data retrieval and viewing components. The tip of the lead is placed near the right ventricular outflow tract to minimize risk of sensor tissue encapsulation. Implant technique and lead placement is similar to that of a permanent pacemaker. After the system had been successfully implanted in 148 patients, the type and frequency of implant-related adverse events were similar to a single-chamber pacemaker implant. R-wave amplitude was 15.2 +/- 6.7 mV and the pressure waveform signal was acceptable in all but two patients in whom presence of artifacts required lead repositioning. Implant procedure time was not influenced by experience, remaining constant throughout the study. Based on this evaluation, permanent placement of an IHM in symptomatic heart failure patients is technically feasible. Further investigation is warranted to evaluate the use of the continuous hemodynamic data in management of heart failure patients.

Management of dental implant fractures. A case history.

PubMed

Al Quran, Firas A M; Rashan, Bashar A; Al-Dwairi, Ziad N

2009-01-01

The widespread use of endosseous osseointegrated implants to replace missing natural teeth increases the chances of implant complications and failures, despite the high initial success rate reported in the literature. Implant fracture is one possible complication that results in ultimate failure of the dental implant. Such a complication poses a management crisis even for the most experienced clinician. This article reports on a case of implant fracture, its possible causes, and how the case was managed.

Comparing membranes and bone substitutes in a one-stage procedure for horizontal bone augmentation. A double-blind randomised controlled trial.

PubMed

Merli, Mauro; Moscatelli, Marco; Mariotti, Giorgia; Pagliaro, Umberto; Raffaelli, Eugenia; Nieri, Michele

2015-01-01

The objective of this parallel randomised controlled trial is to compare two bone substitutes and collagen membranes in a one-stage procedure for horizontal bone augmentation: anorganic bovine bone (Bio-Oss) and collagen porcine membranes (Bio-Gide) (BB group) versus a synthetic resorbable bone graft substitute made of pure β-tricalcium phosphate (Ceros TCP) and porcine pericardium collagen membranes (Jason) (CJ group). Patients in need of implant treatment having at least one site with horizontal osseous defects at a private clinic in Rimini (Italy) were included in this study. Patients were randomised to receive either the BB or CJ treatment. Randomisation was computer-generated with allocation concealment by opaque sequentially numbered sealed envelopes. Patients and the outcome assessor were blinded to group assignment. The main outcome measures were implant failure, complications, clinical bone gain at augmented sites, and complete filling of the bone defect. Secondary outcome measures were chair-time, postoperative pain and peri-implant marginal bone level changes. Twenty-five patients with 32 implants were allocated to the BB group and 25 patients with 29 implants to the CJ group. All 50 randomised patients received the treatment as allocated and there were no dropouts up to 6-months post-loading (12 months post-surgery). There were no failures and there were three complications in the BB group and three complications in the CJ group (relative risk: 1.00, 95% CI from 0.22 to 4.49, P = 1.00). The estimated difference between treatments in the vertical defect bone gain was -0.15 mm (95% CI from -0.65 to 0.35, P = 0.5504) favouring the BB group, and the estimated difference between treatments in the horizontal defect bone gain was -0.27 mm (95%CI from -0.73 to 0.19, P = 0.3851) favouring the BB group. There was no difference in the complete filling of the defect (relative risk: 0.88, 95%CI from 0.58 to 1.34, P = 0.7688). No significant differences were detected for chair-time (P = 0.3524), for VAS pain immediately after surgery (P = 0.5644), VAS pain after 1 week (P = 0.5074) and VAS pain after 2 weeks (P = 0.6950). A slight difference (0.24 mm, 95%CI from 0.0004 to 0.47, P = 0.0464) was detected in radiographic peri-implant bone loss favouring the CJ group. No significant differences, except for radiographic bone loss, were observed in this randomised controlled trial comparing anorganic bovine bone with collagen porcine membranes versus synthetic resorbable bone made of pure β-tricalcium phosphate with pericardium collagen membranes for horizontal augmentation.

PREVAIL TRANSAPICAL: multicentre trial of transcatheter aortic valve implantation using the newly designed bioprosthesis (SAPIEN-XT) and delivery system (ASCENDRA-II).

PubMed

Walther, Thomas; Thielmann, Matthias; Kempfert, Joerg; Schroefel, Holger; Wimmer-Greinecker, Gerhard; Treede, Hendrik; Wahlers, Thorsten; Wendler, Olaf

2012-08-01

Transapical (TA) aortic valve implantation (AVI) has evolved as an alternative procedure for high-risk patients. We evaluated the second-generation SAPIEN XT™ prosthesis in a prospective multicentre clinical trial. A total of 150 patients (age: 81.6 ± 5.8 years; 40.7% female) were included. Prosthetic valves (diameter: 23 mm (n = 36), 26 mm (n = 57) and 29 mm (n = 57)) were implanted. The ASCENDRA-II™ modified delivery system was used in the smaller sizes. Mean logistic EuroSCORE was 24.3 ± 7.0%, and mean STS score 7.5 ± 4.4%. All patients gave written informed consent. Off-pump AVI was performed using femoral arterial and venous access wires as a safety net. All but two patients received TA-AVI, as planned. The 29-mm valve showed similar function as the values of two other diameters did. Three patients (2%) required temporary cardiopulmonary bypass support. Postoperative complications included renal failure requiring long-term dialysis in four, bleeding requiring rethoracotomy in four, respiratory complication requiring reintubation in eight and sepsis in four patients, respectively. Thirty-day mortality was 13 (8.7%) for the total cohort and 2/57 (3.5%) for patients receiving the 29-mm valve, respectively. Echocardiography at discharge showed none or trivial aortic incompetence (AI) in 71% and mild-AI in 22% of the patients. Post-implantation AI was predominantly paravalvular and ≥ 2+ in 7% of patients. One patient required reoperation for AI within 30 days. The PREVAIL TA multicentre trial demonstrates good functionality and good outcomes for TA-AVI, using the SAPIEN XT™ prosthesis and its second-generation ASCENDRA-II™ delivery system, as well successful introduction of the 29-mm SAPIEN XT™ valve for the benefit of high-risk elderly patients.

Comprehensive analysis of cochlear implant failure: usefulness of clinical symptom-based algorithm combined with in situ integrity testing.

PubMed

Yamazaki, Hiroshi; O'Leary, Stephen; Moran, Michelle; Briggs, Robert

2014-04-01

Accurate diagnosis of cochlear implant failures is important for management; however, appropriate strategies to assess possible device failures are not always clear. The purpose of this study is to understand correlation between causes of device failure and the presenting clinical symptoms as well as results of in situ integrity testing and to propose effective strategies for diagnosis of device failure. Retrospective case review. Cochlear implant center at a tertiary referral hospital. Twenty-seven cases with suspected device failure of Cochlear Nucleus systems (excluding CI512 failures) on the basis of deterioration in auditory perception from January 2000 to September 2012 in the Melbourne cochlear implant clinic. Clinical presentations and types of abnormalities on in situ integrity testing were compared with modes of device failure detected by returned device analysis. Sudden deterioration in auditory perception was always observed in cases with "critical damage": either fracture of the integrated circuit or most or all of the electrode wires. Subacute or gradually progressive deterioration in auditory perception was significantly associated with a more limited number of broken electrode wires. Cochlear implant mediated auditory and nonauditory symptoms were significantly associated with an insulation problem. An algorithm based on the time course of deterioration in auditory perception and cochlear implant-mediated auditory and nonauditory symptoms was developed on the basis of these retrospective analyses, to help predict the mode of device failure. In situ integrity testing, which included close monitoring of device function in routine programming sessions as well as repeating the manufacturer's integrity test battery, was sensitive enough to detect malfunction in all suspected device failures, and each mode of device failure showed a characteristic abnormality on in situ integrity testing. Our clinical manifestation-based algorithm combined with in situ integrity testing may be useful for accurate diagnosis and appropriate management of device failure. Close monitoring of device function in routine programming sessions as well as repeating the manufacturer's integrity test battery is important if the initial in situ integrity testing is inconclusive because objective evidence of failure in the implanted device is essential to recommend explantation/reimplantation.

A Prospective Longitudinal Study on Implant Prosthetic Rehabilitation in Controlled HIV-Positive Patients with 1-Year Follow-Up: The Role of CD4+ Level, Smoking Habits, and Oral Hygiene.

PubMed

Gherlone, Enrico F; Capparé, Paolo; Tecco, Simona; Polizzi, Elisabetta; Pantaleo, Giuseppe; Gastaldi, Giorgio; Grusovin, Maria Gabriella

2016-10-01

A recent study showed that implant-prosthetic rehabilitation in well-controlled HIV patients gave slightly worse results than in an healthy population, and failures were all linked to infection. The aim of this study was to examine the associations between the success of implant-prosthetic treatment and systemic CD4+ level, smoking habits, and oral hygiene. This mono-centric study included HIV patients with a stable disease and good oral hygiene requiring implant rehabilitation. Each patient received at least one dental implant. Prosthesis were delivered after 90 days in the upper jaw and 60 days in the lower jaw. Primary outcome measures were prosthetic failures, implant failures, peri-implant marginal bone level changes, and biological complications (peri-implantitis, pus, pain, paresthesia). The possible association with CD4 count, smoking habits, and oral hygiene was analyzed. Sixty-eight patients received 194 implants, and 66 patients (190 implants) were followed for 1 year. No significant associations were found between CD4+ count, oral hygiene-associated variables, and any of the outcome measures. If compared with nonsmoking/light smoking patients, patients who smoked >10 cigarettes/day suffered a statistically significant greater number of implant failures (p ≤ .005), presented a comparatively higher number of peri-implantitis (p < .001), as well as a higher frequency of pus (p ≤ .007), and reported pain (p ≤ .009). Within the limitation of the present study, placement of dental implants in HIV-positive patients with stable disease seems a reasonable treatment option, regardless of CD4+ cell count, provided that they are in a normal range. Oral hygiene variables were not influent in this group of patient following recall appointments, while HIV-positive heavy smokers (>10 cigarettes/day) demonstrated an increased risk of early implant failure, peri-implantitis, episodes of pus, and self-reported pain. © 2015 Wiley Periodicals, Inc.

Single preoperative dose of prophylactic amoxicillin versus a 2-day postoperative course in dental implant surgery: A two-centre randomised controlled trial.

PubMed

Arduino, Paolo G; Tirone, Federico; Schiorlin, Emanuele; Esposito, Marco

2015-01-01

To evaluate the difference between a single preoperative dose versus an additional two-day postoperative course of oral amoxicillin in patients undergoing conventional dental implant placement. Two dentists in two different private practices conducted this study. One hour prior to surgery, patients had to take a single prophylactic antibiotic dose, consisting of 2 g of amoxicillin orally; after implant placement, patients were randomly allocated to two different groups: protocol A (no other antibiotic administration) and protocol B, (1 g of amoxicillin in the evening of the day of surgery and 1 g twice a day for the 2 days after). Outcome measures were prosthetic and implant failures, adverse events and early postoperative complications. Patients were followed up to 6 months after functional loading. Three hundred and sixty patients were randomised and treated (192 patients in one centre and 168 in the other). Five hundred and sixty-seven implants were placed. Protocol A was applied to 180 patients (278 implants) and protocol B also to 180 patients (289 implants). Data for 17 patients, 14 from protocol A and three from protocol B, were not available. No statistically significant differences were found for the reported outcomes. Two patients of protocol B experienced a prosthetic failure, losing four implants, while no prosthetic failures were reported for protocol A (P=0.4836; difference in proportions=-0.0110; 95% CI: -0.0412 to 0.0119). Five patients (3.0%) of protocol A lost five implants versus 5 patients (2.8%) who lost eight implants in protocol B (P=1.0000; difference in proportions=0.0020; 95% CI: -0.0384 to 0.0438). Three adverse events were observed in the total population, all occurring in protocol B (1.69%), with no statistically significant differences between the two groups (P=0.1199; difference in proportions=-0.0170; 95% CI: -0.0487 to 0.0059). However, one patient experienced a severe allergic reaction requiring therapy discontinuation and hospital admission. Early postoperative complications occurred in six patients of protocol A and in four patients of protocol B, with no statistically significant differences (P=0.5170; difference in proportions=0.0130; 95% CI: -0.0254 to 0.0568). No statistically significant differences were observed between 2 g of preoperative amoxicillin and an additional 2-day postoperative course, although adverse events were reported only in the additional 2-day postoperative group. Based on these findings, it might be sufficient to routinely administer preoperatively 2 g of amoxicillin to patients undergoing routine dental implant placement procedures rather than administering additional postoperative doses.

Retrospective cohort study of the clinical performance of 1-stage dental implants.

PubMed

Carr, Alan B; Choi, Yong-Geun; Eckert, Steven E; Desjardins, Ronald P

2003-01-01

To evaluate long-term clinical performance of 1-stage dental implant prostheses at a single clinic, emphasizing clinical and demographic characteristics that affect implant survival. Dental records of all 308 patients (674 implants) treated with 1-stage implants at Mayo Clinic from October 1993 through May 2000 were reviewed from implant placement to last visit. Exposure and outcome variables affecting performance were collected separately to control bias in the data collection process. Additional confounding factors (age and sex) were adjusted with the stratified Cox proportional hazards model. Implant survival was determined by means of a Kaplan-Meier survival estimate. The log-rank test was used to determine the role of clinical and demographic variables in implant survival. The relative risk associated with the possible effect of clinical and demographic variables on implant survival was estimated with the Cox proportional hazards model. The implant survival rate (n = 654 implants) was 97% (mean +/- SD follow-up, 21.0 +/- 18.8 months; range, 1 to 78 months). Performance bias was limited because nearly all patients were treated by 1 prosthodontist. Two implants failed after loading (6 and 9 months). The incidence of complications was less than 4%. Among the implant failures, use of heterogeneous bone graft was associated with 4.8 times more failures than was use of autogenous bone graft (P = .04). After augmentation, delaying implant placement for 5 to 6 months resulted in 8.6 times more failures than the rate after earlier placement (P < .001). Retrospective review of the clinical performance of a 1-stage dental implant system yielded a 97% survival rate, with no failures noted after 13 months. Prosthetic complications were low, especially for fixed implant prostheses. Clinical performance of 1-stage dental implant prostheses between 1993 and 2000 demonstrated a high level of predictability.

A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure.

PubMed

Mehra, Mandeep R; Naka, Yoshifumi; Uriel, Nir; Goldstein, Daniel J; Cleveland, Joseph C; Colombo, Paolo C; Walsh, Mary N; Milano, Carmelo A; Patel, Chetan B; Jorde, Ulrich P; Pagani, Francis D; Aaronson, Keith D; Dean, David A; McCants, Kelly; Itoh, Akinobu; Ewald, Gregory A; Horstmanshof, Douglas; Long, James W; Salerno, Christopher

2017-02-02

Continuous-flow left ventricular assist systems increase the rate of survival among patients with advanced heart failure but are associated with the development of pump thrombosis. We investigated the effects of a new magnetically levitated centrifugal continuous-flow pump that was engineered to avert thrombosis. We randomly assigned patients with advanced heart failure to receive either the new centrifugal continuous-flow pump or a commercially available axial continuous-flow pump. Patients could be enrolled irrespective of the intended goal of pump support (bridge to transplantation or destination therapy). The primary end point was a composite of survival free of disabling stroke (with disabling stroke indicated by a modified Rankin score >3; scores range from 0 to 6, with higher scores indicating more severe disability) or survival free of reoperation to replace or remove the device at 6 months after implantation. The trial was powered for noninferiority testing of the primary end point (noninferiority margin, -10 percentage points). Of 294 patients, 152 were assigned to the centrifugal-flow pump group and 142 to the axial-flow pump group. In the intention-to-treat population, the primary end point occurred in 131 patients (86.2%) in the centrifugal-flow pump group and in 109 (76.8%) in the axial-flow pump group (absolute difference, 9.4 percentage points; 95% lower confidence boundary, -2.1 [P<0.001 for noninferiority]; hazard ratio, 0.55; 95% confidence interval [CI], 0.32 to 0.95 [two-tailed P=0.04 for superiority]). There were no significant between-group differences in the rates of death or disabling stroke, but reoperation for pump malfunction was less frequent in the centrifugal-flow pump group than in the axial-flow pump group (1 [0.7%] vs. 11 [7.7%]; hazard ratio, 0.08; 95% CI, 0.01 to 0.60; P=0.002). Suspected or confirmed pump thrombosis occurred in no patients in the centrifugal-flow pump group and in 14 patients (10.1%) in the axial-flow pump group. Among patients with advanced heart failure, implantation of a fully magnetically levitated centrifugal-flow pump was associated with better outcomes at 6 months than was implantation of an axial-flow pump, primarily because of the lower rate of reoperation for pump malfunction. (Funded by St. Jude Medical; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755 .).

Fracture Resistance and Mode of Failure of Ceramic versus Titanium Implant Abutments and Single Implant-Supported Restorations.

PubMed

Sghaireen, Mohd G

2015-06-01

The material of choice for implant-supported restorations is affected by esthetic requirements and type of abutment. This study compares the fracture resistance of different types of implant abutments and implant-supported restorations and their mode of failure. Forty-five Oraltronics Pitt-Easy implants (Oraltronics Dental Implant Technology GmbH, Bremen, Germany) (4 mm diameter, 10 mm length) were embedded in clear autopolymerizing acrylic resin. The implants were randomly divided into three groups, A, B and C, of 15 implants each. In group A, titanium abutments and metal-ceramic crowns were used. In group B, zirconia ceramic abutments and In-Ceram Alumina crowns were used. In group C, zirconia ceramic abutments and IPS Empress Esthetic crowns were used. Specimens were tested to failure by applying load at 130° from horizontal plane using an Instron Universal Testing Machine. Subsequently, the mode of failure of each specimen was identified. Fracture resistance was significantly different between groups (p < .05). The highest fracture loads were associated with metal-ceramic crowns supported by titanium abutments (p = .000). IPS Empress crowns supported by zirconia abutments had the lowest fracture loads (p = .000). Fracture modes of metal-ceramic crowns supported by titanium abutments included screw fracture and screw bending. Fracture of both crown and abutment was the dominant mode of failure of In-Ceram/IPS Empress crowns supported by zirconia abutments. Metal-ceramic crowns supported by titanium abutments were more resistant to fracture than In-Ceram crowns supported by zirconia abutments, which in turn were more resistant to fracture than IPS Empress crowns supported by zirconia abutments. In addition, failure modes of restorations supported by zirconia abutments were more catastrophic than those for restorations supported by titanium abutments. © 2013 Wiley Periodicals, Inc.

Implant failure and history of failed endodontic treatment: A retrospective case-control study.

PubMed

Chatzopoulos, Georgios S; Wolff, Larry F

2017-11-01

Residual bacterial biofilm and/or bacteria in planktonic form may be survived in the bone following an extraction of an infected tooth that was endodontically treated unsuccessfully Failed endodontic treatment may be associated with failure of implants to osseointegrate in the same sites. Therefore, the aim of this retrospective case-control study is to examine the risk of implant failure in previous failed endodontic sites. This retrospective case-control study is based on 94 dental records of implants placed at the University of Minnesota School of Dentistry. Dental records of patients who received an implant in sites with previously failed endodontic therapy in the dental school were identified from the electronic database, while control subjects were obtained from the same pool of patients with the requirement to have received an implant in a site that was not endodontically treated. The mean age of the population was 62.89±14.17 years with 57.4% of the sample being females and 42.6% of them being males. In regards to the socio-economic status and dental insurance, 84.0% of this population was classified as low socio-economic status and 68.1% had dental insurance. Tobacco use was self-reported by 9.6% and hypercholesterolemia was the most prevalent systemic medical condition. Dental implant failure was identified in two of the included records (2.1%), both of which were placed in sites with a history of failed endodontic treatment. Within the limitations of this retrospective case-control study, further investigation with a larger population group into implant failure of sites that previously had unsuccessful endodontic treatment would be warranted. Implant failure may be associated with a history of failed endodontic treatment. Key words: Implantology, endodontics, osseointegration, treatment outcome, case-control study.

Outcomes of implants and restorations placed in general dental practices: a retrospective study by the Practitioners Engaged in Applied Research and Learning (PEARL) Network.

PubMed

Da Silva, John D; Kazimiroff, Julie; Papas, Athena; Curro, Frederick A; Thompson, Van P; Vena, Donald A; Wu, Hongyu; Collie, Damon; Craig, Ronald G

2014-07-01

The authors conducted a study to determine the types, outcomes, risk factors and esthetic assessment of implants and their restorations placed in the general practices of a practice-based research network. All patients who visited network practices three to five years previously and underwent placement of an implant and restoration within the practice were invited to enroll. Practitioner-investigators (P-Is) recorded the status of the implant and restoration, characteristics of the implant site and restoration, presence of peri-implant pathology and an esthetic assessment by the P-I and patient. The P-Is classified implants as failures if the original implant was missing or had been replaced, the implant was mobile or elicited pain on percussion, there was overt clinical or radiographic evidence of pathology or excessive bone loss (> 0.2 millimeter per year after an initial bone loss of 2 mm). They classified restorations as failures if they had been replaced or if there was abutment or restoration fracture. The authors enrolled 922 implants and patients from 87 practices, with a mean (standard deviation) follow-up of 4.2 (0.6) years. Of the 920 implants for which complete data records were available, 64 (7.0 percent) were classified as failures when excessive bone loss was excluded from the analysis. When excessive bone loss was included, 172 implants (18.7 percent) were classified as failures. According to the results of univariate analysis, a history of severe periodontitis, sites with preexisting inflammation or type IV bone, cases of immediate implant placement and placement in the incisor or canine region were associated with implant failure. According to the results of multivariate analysis, sites with preexisting inflammation (odds ratio [OR] = 2.17; 95 percent confidence interval [CI], 1.41-3.34]) or type IV bone (OR = 1.99; 95 percent CI, 1.12-3.55) were associated with a greater risk of implant failure. Of the 908 surviving implants, 20 (2.2 percent) had restorations replaced or judged as needing to be replaced. The majority of P-Is and patients were satisfied with the esthetic outcomes for both the implant and restoration. These results suggest that implant survival and success rates in general dental practices may be lower than those reported in studies conducted in academic or specialty settings. The results of this study, generated in the private general practice setting, add to the evidence base to facilitate implant treatment planning.

Revision Distal Femoral Arthroplasty With the Compress(®) Prosthesis Has a Low Rate of Mechanical Failure at 10 Years.

PubMed

Zimel, Melissa N; Farfalli, German L; Zindman, Alexandra M; Riedel, Elyn R; Morris, Carol D; Boland, Patrick J; Healey, John H

2016-02-01

Patients with failed distal femoral megaprostheses often have bone loss that limits reconstructive options and contributes to the high failure rate of revision surgery. The Compress(®) Compliant Pre-stress (CPS) implant can reconstruct the femur even when there is little remaining bone. It differs from traditional stemmed prostheses because it requires only 4 to 8 cm of residual bone for fixation. Given the poor long-term results of stemmed revision constructs, we sought to determine the failure rate and functional outcomes of the CPS implant in revision surgery. (1) What is the cumulative incidence of mechanical and other types of implant failure when used to revise failed distal femoral arthroplasties placed after oncologic resection? (2) What complications are characteristic of this prosthesis? (3) What function do patients achieve after receiving this prosthesis? We retrospectively reviewed 27 patients who experienced failure of a distal femoral prosthesis and were revised to a CPS implant from April 2000 to February 2013. Indications for use included a minimum 2.5 mm cortical thickness of the remaining proximal femur, no prior radiation, life expectancy > 10 years, and compliance with protected weightbearing for 3 months. The cumulative incidence of failure was calculated for both mechanical (loss of compression between the implant anchor plug and spindle) and other failure modes using a competing risk analysis. Failure was defined as removal of the CPS implant. Followup was a minimum of 2 years or until implant removal. Median followup for patients with successful revision arthroplasty was 90 months (range, 24-181 months). Functional outcomes were measured with the Musculoskeletal Tumor Society (MSTS) functional assessment score. The cumulative incidence of mechanical failure was 11% (95% confidence interval [CI], 4%-33%) at both 5 and 10 years. These failures occurred early at a median of 5 months. The cumulative incidence of other failures was 18% (95% CI, 7%-45%) at 5 and 10 years, all of which were deep infection. Three patients required secondary operations for cortical insufficiency proximal to the anchor plug in bone not spanned by the CPS implant and unrelated to the prosthesis. Median MSTS score was 27 (range, 24-30). Revision distal femoral replacement arthroplasty after a failed megaprosthesis is often difficult as a result of a lack of adequate bone. Reconstruction with the CPS implant has an 11% failure rate at 10 years. Our results are promising and demonstrate the durable fixation provided by the CPS implant. Further studies to compare the CPS prosthesis and other reconstruction options with respect to survival and functional outcomes are warranted. Level IV, therapeutic study.

Bruxism and Dental Implants: A Meta-Analysis.

PubMed

Chrcanovic, Bruno Ramos; Albrektsson, Tomas; Wennerberg, Ann

2015-10-01

To test the null hypothesis of no difference in the implant failure rates, postoperative infection, and marginal bone loss after the insertion of dental implants in bruxers compared with the insertion in non-bruxers against the alternative hypothesis of a difference. An electronic search was undertaken in June 2014. Eligibility criteria included clinical studies, either randomized or not. Ten publications were included with a total of 760 implants inserted in bruxers (49 failures; 6.45%) and 2989 in non-bruxers (109 failures; 3.65%). Due to lack of information, meta-analyses for the outcomes "postoperative infection" and "marginal bone loss" were not possible. A risk ratio of 2.93 was found (95% confidence interval, 1.48-5.81; P = 0.002). These results cannot suggest that the insertion of dental implants in bruxers affects the implant failure rates due to a limited number of published studies, all characterized by a low level of specificity, and most of them deal with a limited number of cases without a control group. Therefore, the real effect of bruxing habits on the osseointegration and survival of endosteal dental implants is still not well established.

Intraoperative Transesophageal Echocardiography and Right Ventricular Failure After Left Ventricular Assist Device Implantation.

PubMed

Silverton, Natalie A; Patel, Ravi; Zimmerman, Josh; Ma, Jianing; Stoddard, Greg; Selzman, Craig; Morrissey, Candice K

2018-02-15

To determine whether intraoperative measures of right ventricular (RV) function using transesophageal echocardiography are associated with subsequent RV failure after left ventricular assist device (LVAD) implantation. Retrospective, nonrandomized, observational study. Single tertiary-level, university-affiliated hospital. The study comprised 100 patients with systolic heart failure undergoing elective LVAD implantation. Transesophageal echocardiographic images before and after cardiopulmonary bypass were analyzed to quantify RV function using tricuspid annular plane systolic excursion (TAPSE), tricuspid annular systolic velocity (S'), fractional area change (FAC), RV global longitudinal strain, and RV free wall strain. A chart review was performed to determine which patients subsequently developed RV failure (right ventricular assist device placement or prolonged inotrope requirement ≥14 days). Nineteen patients (19%) subsequently developed RV failure. Postbypass FAC was the only measure of RV function that distinguished between the RV failure and non-RV failure groups (21.2% v 26.5%; p = 0.04). The sensitivity, specificity, and area under the curve of an abnormal RV FAC (<35%) for RV failure after LVAD implantation were 84%, 20%, and 0.52, respectively. No other intraoperative measure of RV function was associated with subsequent RV failure. RV failure increased ventilator time, intensive care unit and hospital length of stay, and mortality. Intraoperative measures of RV function such as tricuspid annular plane systolic excursion, tricuspid annular systolic velocity, and RV strain were not associated with RV failure after LVAD implantation. Decreased postbypass FAC was significantly associated with RV failure but showed poor discrimination. Copyright © 2018 Elsevier Inc. All rights reserved.

Implementing a cardiac resynchronization therapy program in a county hospital.

PubMed

Merchant, Karen; Laborde, Ann

2005-09-01

Clinical trials and research literature show the benefits of cardiac resynchronization therapy and implantable cardioverter defibrillator devices in improving the quality of life for selected patients with heart failure. While translating these positive research results into clinical practice is a major effort requiring a strategic planning process, implementing these practices in-house may result in cost savings and possible increased revenue. The authors describe the planning and implementation process used to introduce these therapies in a cardiac catheterization laboratory at a county teaching hospital.

Follow-up of the original cohort with the Ahmed glaucoma valve implant.

PubMed

Topouzis, F; Coleman, A L; Choplin, N; Bethlem, M M; Hill, R; Yu, F; Panek, W C; Wilson, M R

1999-08-01

To study the long-term results of the Ahmed glaucoma valve implant in patients with complicated glaucoma in whom short-term results have been reported. In this multicenter study, we analyzed the long-term outcome of a cohort of 60 eyes from 60 patients in whom the Ahmed glaucoma valve was implanted. Failure was characterized by at least one of the following: intraocular pressure greater than 21 mm Hg at both of the last two visits less than 6 mm Hg at both of the last two visits, loss of light perception, additional glaucoma surgery, devastating complications, and removal or replacement of the Ahmed glaucoma valve implant. Devastating complications included chronic hypotony, retinal detachment, malignant glaucoma, endophthalmitis, and phthisis bulbi; we also report results that add corneal complications (corneal decompensation or edema, corneal graft failure) as defining a devastating complication. The mean follow-up time for the 60 eyes was 30.5 months (range, 2.1 to 63.5). When corneal complications were included in the definition of failure, 26 eyes (43%) were considered failures. Cumulative probabilities of success at 1, 2, 3, and 4 years were 76%, 68%, 54%, and 45%, respectively. When corneal complications were excluded from the definition of failure, 13 eyes (21.5%) were considered failures. Cumulative probabilities of success at 1, 2, 3, and 4 years were 87%, 82%, 76%, and 76%, respectively. Most of the failures after 12 months of postoperative follow-up were because of corneal complications. The long-term performance of the Ahmed glaucoma valve implant is comparable to other drainage devices. More than 12 months after the implantation of the Ahmed glaucoma valve implant, the most frequent adverse outcome was corneal decompensation or corneal graft failure. These corneal problems may be secondary to the type of eyes that have drainage devices or to the drainage device itself. Further investigation is needed to identify the reasons that corneal problems follow drainage device implantation.

The Oxford unicompartmental knee fails at a high rate in a high-volume knee practice.

PubMed

Schroer, William C; Barnes, C Lowry; Diesfeld, Paul; LeMarr, Angela; Ingrassia, Rachel; Morton, Diane J; Reedy, Mary

2013-11-01

The Oxford knee is a unicompartmental implant featuring a mobile-bearing polyethylene component with excellent long-term survivorship results reported by the implant developers and early adopters. By contrast, other studies have reported higher revision rates in large academic practices and in national registries. Registry data have shown increased failure with this implant especially by lower-volume surgeons and institutions. In the setting of a high-volume knee arthroplasty practice, we sought to determine (1) the failure rate of the Oxford unicompartmental knee implant using a failure definition for aseptic loosening that combined clinical features, plain radiographs, and scintigraphy, and (2) whether increased experience with this implant would decrease failure rate, if there is a learning curve effect. Eighty-three Oxford knee prostheses were implanted between September 2005 and July 2008 by the principal investigator. Radiographic and clinical data were available for review for all cases. A failed knee was defined as having recurrent pain after an earlier period of recovery from surgery, progressive radiolucent lines compared with initial postoperative radiographs, and a bone scan showing an isolated area of uptake limited to the area of the replaced compartment. Eleven knees in this series failed (13%); Kaplan-Meier survivorship was 86.5% (95% CI, 78.0%-95.0%) at 5 years. Failure occurrences were distributed evenly over the course of the study period. No learning curve effect was identified. Based on these findings, including a high failure rate of the Oxford knee implant and the absence of any discernible learning curve effect, the principal investigator no longer uses this implant.

Advances in Clinical Cardiology 2016: A Summary of the Key Clinical Trials.

PubMed

Gray, Alastair; McQuillan, Conor; Menown, Ian B A

2017-07-01

The findings of many new cardiology clinical trials over the last year have been published or presented at major international meetings. This paper aims to describe and place in context a summary of the key clinical trials in cardiology presented between January and December 2016. The authors reviewed clinical trials presented at major cardiology conferences during 2016 including the American College of Cardiology (ACC), European Association for Percutaneous Cardiovascular Interventions (EuroPCR), European Society of Cardiology (ESC), European Association for the Study of Diabetes (EASD), Transcatheter Cardiovascular Therapeutics (TCT), and the American Heart Association (AHA). Selection criteria were trials with a broad relevance to the cardiology community and those with potential to change current practice. A total of 57 key cardiology clinical trials were identified for inclusion. Here we describe and place in clinical context the key findings of new data relating to interventional and structural cardiology including delayed stenting following primary angioplasty, contrast-induced nephropathy, management of jailed wires, optimal duration of dual antiplatelet therapy (DAPT), stenting vs bypass for left main disease, new generation stents (BioFreedom, Orsiro, Absorb), transcatheter aortic valve implantation (Edwards Sapien XT, transcatheter embolic protection), and closure devices (Watchman, Amplatzer). New preventative cardiology data include trials of bariatric surgery, empagliflozin, liraglutide, semaglutide, PCSK9 inhibitors (evolocumab and alirocumab), and inclisiran. Antiplatelet therapy trials include platelet function monitoring and ticagrelor vs clopidogrel for peripheral vascular disease. New data are also presented in fields of heart failure (sacubitril/valsartan, aliskiren, spironolactone), atrial fibrillation (rivaroxaban in patients undergoing coronary intervention, edoxaban in DC cardioversion), cardiac devices (implantable cardioverter defibrillator in non-ischemic cardiomyopathy), and electrophysiology (cryoballoon vs radiofrequency ablation). This paper presents a summary of key clinical cardiology trials during the past year and should be of practical value to both clinicians and cardiology researchers.

The Ahmed Versus Baerveldt Study: Five-Year Treatment Outcomes.

PubMed

Christakis, Panos G; Kalenak, Jeffrey W; Tsai, James C; Zurakowski, David; Kammer, Jeffrey A; Harasymowycz, Paul J; Mura, Juan J; Cantor, Louis B; Ahmed, Iqbal I K

2016-10-01

To compare 2 frequently used aqueous shunts for the treatment of glaucoma. International, multicenter, randomized trial. Patients aged 18 years or older with uncontrolled glaucoma despite maximum tolerated medical therapy, many of whom had failed or were at high risk of failing trabeculectomy. Eligible patients were randomized to receive an Ahmed-FP7 valve implant (New World Medical, Inc, Rancho Cucamonga, CA) or a Baerveldt-350 implant (Abbott Medical Optics, Inc, Santa Ana, CA) using a standardized surgical technique. The primary outcome was failure, defined as intraocular pressure (IOP) outside the target range (5-18 mmHg) or reduced <20% from baseline for 2 consecutive visits after 3 months, severe vision loss, or de novo glaucoma surgery. Secondary outcomes measures included IOP, medication use, visual acuity, complications, and interventions. A total of 238 patients were randomized; 124 received the Ahmed-FP7 implant, and 114 received the Baerveldt-350 implant. Baseline characteristics were similar between groups. Mean preoperative IOP was 31.4±10.8 mmHg on 3.1±1.0 glaucoma medications. At 5 years, the cumulative failure rate was 53% in the Ahmed group and 40% in the Baerveldt group (P = 0.04). The main reason for failure in both groups was high IOP, and the cumulative de novo glaucoma reoperation rate was 18% in the Ahmed group and 11% in the Baerveldt group (P = 0.22). Hypotony resulted in failure in 5 patients (4%) in the Baerveldt group compared with none in the Ahmed group (P = 0.02). Mean IOP was 16.6±5.9 mmHg in the Ahmed group (47% reduction) and 13.6±5.0 mmHg in the Baerveldt group (57% reduction, P = 0.001). Mean medication use was 1.8±1.5 mmHg in the Ahmed group (44% reduction) and 1.2±1.3 mmHg in the Baerveldt group (61% reduction, P = 0.03). The 2 groups had similar complication rates (Ahmed 63%, Baerveldt 69%) and intervention rates (Ahmed 41%, Baerveldt 41%). Most complications were transient, and most interventions were slit-lamp procedures. Both implants were effective in reducing IOP and the need for glaucoma medications. The Baerveldt group had a lower failure rate and a lower IOP on fewer medications than the Ahmed group, but had a small risk of hypotony that was not seen in the Ahmed group. Copyright © 2016 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Factors affecting the decision to replace failed implants: a retrospective study.

PubMed

Mardinger, Ofer; Oubaid, Saheer; Manor, Yifat; Nissan, Joseph; Chaushu, Gavriel

2008-12-01

The purpose of the present study was to explore the major factors that can affect the decision to replace failed implants. A retrospective cohort study was conducted on 194 patients who presented following dental implant failure during a 6-year period (2000 to 2006). The collected data included patient characteristics, failed implant characteristics, the anatomic status of the alveolar ridge after failure, and factors affecting the decision to avoid reimplantation. The study group included patients in whom the failed dental implants were replaced, whereas there was no reimplantation in the control group. Seventy-four patients (135 implants) made up the control group, and 120 patients (157 implants) made up the study group. The mean patient age was higher and the medical status was worse in the control group. The number of failed implants per patient was higher in the control group. The time between the diagnosis of failure and removal and between implant placement and removal were greater in the control group. The chances of a patient with minor bone loss undergoing reimplantation was 20 times greater (odds ratio, 20.4) than a patient with severe bone loss. The main patient-related reasons for avoiding reimplantation were the additional costs (27%), fear of additional pain (17.7%), and fear of a second failure (16.2%). The removal of a failing implant as soon as it is diagnosed as hopeless will improve the chances for reimplantation.

Survival of modern knee tumor megaprostheses: failures, functional results, and a comparative statistical analysis.

PubMed

Pala, Elisa; Trovarelli, Giulia; Calabrò, Teresa; Angelini, Andrea; Abati, Caterina N; Ruggieri, Pietro

2015-03-01

Modular megaprostheses are now the most common method of reconstruction after segmental resection of the long bones in the lower extremities. Previous studies reported variable outcome and failure rates after knee megaprosthetic reconstructions. The objectives of this study were to analyze the results of a modular tumor prosthesis after resection of bone tumor around the knee with respect to (1) survivorship; (2) failure rate; (3) comparative survivorship against different sites of reconstructions and of primary and revision implants; and (4) functional results on the Musculoskeletal Tumor Society (MSTS) scoring system. Between 2003 and 2010, 247 rotating-hinge Global Modular Reconstruction System (GMRS) knee prostheses were implanted in our institute for malignant and aggressive benign tumors. During this time, that group represented 23% of the patients who had oncologic megaprosthesis reconstruction about the knee after resection of primary or metastatic bone tumors (247 of 1086 patients). In the other 77% of cases we used other types of oncologic prostheses. Before 2003 we used the older Howmedica Modular Resection System and Kotz Modular Femur/Tibia Replacement from 2003 we used mostly the GMRS but we continued to use the HMRS in some cases such as patients with poor prognoses, elderly patients, or metastatic patients. Sites included 187 distal femurs and 60 proximal tibias. Causes of megaprosthesis failure were classified according to Henderson et al. in five types: Type 1 (soft tissue failure), Type 2 (aseptic loosening), Type 3 (structural failure), Type 4 (infection), and Type 5 (tumor progression). Followup was at a minimum oncologic followup of 2 years (mean, 4 years; range, 2-8 years). Kaplan-Meier actuarial curves of implant survival to major failures were done. Functional results were analyzed according to the MSTS II system; 223 of the 247 were available for functional scoring (81%). At latest followup, among 175 treated patients for primary reconstruction, 117 are continuously disease-free, 26 have no evidence of disease after treatment of relapse, eight are alive with disease, and 24 died from disease. The overall failure rate of the megaprostheses in our series was 29.1% (72 of 247). Type 1 failure occurred in 8.5% (21 of 247) cases, Type 2 in 5.6% (14 of 247), Type 3 in 0%, Type 4 in 9.3% (23 of 247), and Type 5 in 5.6% (14 of 247). Kaplan-Meier curve showed an overall implant survival rate for all types of failures of 70% at 4 years and 58% at 8 years. Prosthetic survivorship for revisions was 80% at 5 years and for primary reconstructions was 60% at 5 years (p = 0.013). Survivorship to infection was 95% at 5 years for revision patients and 84% at 5 years for primary patients (p = 0.475). The mean MSTS score was 84 (25.2; range, 8-30) with no difference between sites of localization (24.7 in proximal tibia versus 25.4 in distal femur reconstruction; p = 0.306). Results at a minimum of 2 years with this modular prosthesis are satisfactory in terms of survivorship (both oncologic and reconstructive) and causes and rates of failure. Although these results seem comparable with other like implants, we will continue to follow this cohort, and we believe that comparative trials among the available megaprosthesis designs are called for. Level IV, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

Impact of Remote Monitoring on Long-Term Prognosis in Heart Failure Patients in a Real-World Cohort: Results From All-Comers COMMIT-HF Trial.

PubMed

Kurek, Anna; Tajstra, Mateusz; Gadula-Gacek, Elzbieta; Buchta, Piotr; Skrzypek, Michal; Pyka, Lukasz; Wasiak, Michal; Swietlinska, Malgorzata; Hawranek, Michal; Polonski, Lech; Gasior, Mariusz; Kosiuk, Jedrzej

2017-04-01

Randomized controlled trials demonstrate that remote monitoring (RM) of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT-Ds) may improve quality of care and prognosis in heart failure (HF) patients. However, the impact of RM on long-term mortality in a real-world cohort is still not well examined. This study was designed as a matched cohort study based on the COMMIT-HF trial--a single-center, ongoing prospective observational registry (NCT02536443). Complete patient demographics, medical history, in-hospital results, hospitalizations, and mortality data were collected based on institutional registries and healthcare providers' records. Patients were divided into 2 groups based on RM presence and matched by means of propensity scores according to clinical characteristics. The primary endpoint of this study was the long-term all-cause mortality. Out of 1,429 consecutive patients, 822 patients with a first implantation of an ICD/CRT-D were included in the analysis. The final matched study population contained 574 patients in RM and in a control group. Although demographic and echocardiographic parameters as well as pharmacological treatments were similar in both groups, a significantly lower 1-year mortality was detected in the RM group (2.1% vs. 11.5%, P < 0.0001). This was also maintained during a 3-year follow-up (4.9% vs. 22.3%, P < 0.0001). Multivariate analysis showed that RM was associated with an improved prognosis (hazard ratio 0.187, 95% confidence interval 0.075-0.467, P = 0.0003). RM of HF patients with ICDs/CRT-Ds significantly reduced long-term mortality in a real-world clinical condition. © 2017 Wiley Periodicals, Inc.

A pilot trial comparing the tear-out behavior in screw-sockets and cemented polyethylene acetabular components - a cadaveric study.

PubMed

Möbius, R; Schleifenbaum, S; Grunert, R; Löffler, S; Werner, M; Prietzel, T; Hammer, N

2016-10-01

The removal of well-fixed acetabular components following THA (total hip arthroplasty) is a difficult operation and could be accompanied by the loss of acetabular bone stock. The optimal method for fixation is still under debate. The aim of this pilot study was to compare the tear-out resistance and failure behavior between osseo-integrated and non-integrated screw cups. Furthermore, we examined whether there are differences in the properties mentioned between screw sockets and cemented polyethylene cups. Tear-out resistance and related mechanical work required for the tear-out of osseo-integrated screw sockets are higher than in non-integrated screw sockets. Ten human coxal bones from six cadavers with osseo-integrated screw sockets (n=4), non-integrated (implanted post-mortem, n=3) screw sockets and cemented polyethylene cups (n=3) were used for tear-out testing. The parameters axial failure load and mechanical work for tear-out were introduced as measures for determining the stability of acetabular components following THA. The osseo-integrated screw sockets yielded slightly higher tear-out resistance (1.61±0.26kN) and related mechanical work compared to the non-integrated screw sockets (1.23±0.39kN, P=0.4). The cemented polyethylene cups yielded the lowest tear-out resistance with a failure load of 1.18±0.24kN. Compared to the screw cups implanted while alive, they also differ on a non-significant level (P=0.1). Osseous failure patterns differed especially for the screw sockets compared to the cemented polyethylene cups. Osseo-integration did not greatly influence the tear-out stability in cementless screw sockets following axial loading. Furthermore, the strength of the bone-implant-interface of cementless screw sockets appears to be similar to cemented polyethylene cups. However, given the high failure load, high mechanical load and because of the related bone failure patterns, removal should not be performed by means of tear-out but rather by osteotomes or other curved cutting devices to preserve the acetabular bone stock. Level III, case-control-study. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Sino-implant (II) - a levonorgestrel-releasing two-rod implant: systematic review of the randomized controlled trials

PubMed Central

Steiner, Markus J.; Lopez, Laureen M.; Grimes, David A.; Cheng, Linan; Shelton, Jim; Trussell, James; Farley, Timothy M.M.; Dorflinger, Laneta

2013-01-01

Background Sino-implant (II) is a subdermal contraceptive implant manufactured in China. This two-rod levonorgestrel-releasing implant has the same amount of active ingredient (150 mg levonorgestrel) and mechanism of action as the widely available contraceptive implant Jadelle. We examined randomized controlled trials of Sino-implant (II) for effectiveness and side effects. Study design We searched electronic databases for studies of Sino-implant (II), and then restricted our review to randomized controlled trials. The primary outcome of this review was pregnancy. Results Four randomized trials with a total of 15,943 women assigned to Sino-implant (II) had first-year probabilities of pregnancy ranging from 0.0% to 0.1%. Cumulative probabilities of pregnancy during the four years of the product's approved duration of use were 0.9% and 1.06% in the two trials that presented date for four-year use. Five-year cumulative probabilities of pregnancy ranged from 0.7% to 2.1%. In one trial, the cumulative probability of pregnancy more than doubled during the fifth year (from 0.9% to 2.1%), which may be why the implant is approved for four years of use in China. Five-year cumulative probabilities of discontinuation due to menstrual problems ranged from 12.5% to 15.5% for Sino-implant (II). Conclusions Sino-implant (II) is one of the most effective contraceptives available today. These available clinical data, combined with independent laboratory testing, and the knowledge that 7 million women have used this method since 1994, support the safety and effectiveness of Sino-implant (II). The lower cost of Sino-implant (II) compared with other subdermal implants could improve access to implants in resource-constrained settings. PMID:20159174

The contraceptive efficacy of Implanon: a review of clinical trials and marketing experience.

PubMed

Graesslin, Olivier; Korver, Tjeerd

2008-06-01

To evaluate the contraceptive efficacy of the etonogestrel-releasing implant Implanon as assessed in international studies and during nine years of marketing experience. The analysis included 11 international studies and data collected during nine years of marketing experience (1998--2007). Seven of these studies were noncomparative; the four other studies included the 6-rod levonorgestrel implant system or an intrauterine device as a comparator. All studies except one were of at least two years in duration, and all had contraceptive efficacy as the objective. Market data were provided unsolicited to Organon, part of Schering Plough. The integrated efficacy analysis included 923 non-breastfeeding women who were exposed to the implant for 24,100 cycles. No in-treatment or pretreatment pregnancies were reported. Fifty posttreatment pregnancies were reported, six of which occurred within 14 days of implant removal, indicating that fertility had quickly returned. Over a nine-year marketing period an overall pregnancy rate of 0.049 per 100 implants sold (estimated Pearl Index = 0.031 based on all pregnancies reported) was calculated. When only counting contraceptive method failures the pregnancy rate amounts to 0.010 per 100 implants sold (estimated Pearl Index = 0.006). Implanon is a highly effective and quickly reversible subdermal method of long-acting hormonal contraception for women. Typical use of this implant achieves a contraceptive protection exceeding 99%.

Sex Differences in Device Therapy for Heart Failure: Utilization, Outcomes, and Adverse Events

PubMed Central

Herz, Naomi D.; Engeda, Joseph; Zusterzeel, Robbert; Sanders, William E.; O'Callaghan, Kathryn M.; Strauss, David G.; Jacobs, Samantha B.; Selzman, Kimberly A.; Piña, Ileana L.

2015-01-01

Abstract Background: Multiple studies of heart failure patients demonstrated significant improvement in exercise capacity, quality of life, cardiac left ventricular function, and survival from cardiac resynchronization therapy (CRT), but the underenrollment of women in these studies is notable. Etiological and pathophysiological differences may result in different outcomes in response to this treatment by sex. The observed disproportionate representation of women suggests that many women with heart failure either do not meet current clinical criteria to receive CRT in trials or are not properly recruited and maintained in these studies. Methods: We performed a systematic literature review through May 2014 of clinical trials and registries of CRT use that stratified outcomes by sex or reported percent women included. One-hundred eighty-three studies contained sex-specific information. Results: Ninety percent of the studies evaluated included ≤35% women. Fifty-six articles included effectiveness data that reported response with regard to specific outcome parameters. When compared with men, women exhibited more dramatic improvement in specific parameters. In the studies reporting hazard ratios for hospitalization or death, women generally had greater benefit from CRT. Conclusions: Our review confirms women are markedly underrepresented in CRT trials, and when a CRT device is implanted, women have a therapeutic response that is equivalent to or better than in men, while there is no difference in adverse events reported by sex. PMID:25793483

Ethical challenges of deactivation of cardiac devices in advanced heart failure.

PubMed

Chamsi-Pasha, Hassan; Chamsi-Pasha, Mohammed A; Albar, Mohammed Ali

2014-06-01

More than 23 million adults worldwide have heart failure (HF). Although survival after heart failure diagnosis has improved over time, mortality from heart failure remains high. At the end of life, the chronic HF patient often becomes increasingly symptomatic, and may have other life-limiting comorbidities as well. Multiple trials have shown a clear mortality benefit with the use of implantable cardioverter defibrillators (ICDs) in patients with cardiomyopathy and ventricular arrhythmia. However, patients who have an ICD may be denied the chance of a sudden cardiac death, and instead are committed to a slower terminal decline, with frequent DC shocks that can be painful and decrease the quality of life, greatly contributing to their distress and that of their families during this period. While patients with ICDs are routinely counseled with regard to the benefits of ICDs, they have a poor understanding of the options for device deactivation and related ethical and legal implications. Deactivating an ICD or not performing a generator change is both legal and ethical, and is supported by guidelines from both sides of the Atlantic. Patient autonomy is paramount, and no patient is committed to any therapy that they no longer wish to receive. Left ventricular assist devices (LVADs) were initially used as bridge in patients awaiting heart transplantation, but they are currently implanted as destination therapy (DT) in patients with end-stage heart failure who have failed to respond to optimal medical therapy and who are ineligible for cardiac transplantation. The decision-making process for initiation and deactivation of LVAD is becoming more and more ethically and clinically challenging, particularly for elderly patients.

A worldwide experience of the management of battery failures and chronic device retrieval of the Nanostim leadless pacemaker.

PubMed

Lakkireddy, Dhanunjaya; Knops, Reinoud; Atwater, Brett; Neuzil, Petr; Ip, John; Gonzalez, Elkin; Friedman, Paul; Defaye, Pascal; Exner, Derek; Aonuma, Kazutaka; Doshi, Rahul; Sperzel, Johannes; Reddy, Vivek

2017-12-01

The Nanostim leadless pacemaker (LP) met the primary endpoints in an investigational device exemption trial, and was shown to be fully retrievable percutaneously. In October 2016, St Jude Medical issued a worldwide alert of a battery malfunction that caused lost pacing output and LP communication. To report the battery failure mechanism and incidence and the worldwide patient management, including device retrieval experiences. The affected LP battery is a custom lithium-carbon monofluoride cell. These were returned after failure and underwent analysis assessing electronics and battery performance. Data were collected in ongoing clinical studies when LPs were abandoned or retrieved. Of 1423 LPs implanted worldwide, there were 34 battery failures, occurring at 2.9 ± 0.4 years with no instances of associated patient injury. Analysis of returned batteries revealed an increase in battery resistance caused by insufficient electrolyte availability at the cathode/anode interface. A total of 66 of 73 retrieval attempts were successful (90.4%; implant duration range: 0.2-4.0 years). The LP docking button was inaccessible in 6 patients, and the docking button detached from the LP during retrieval in 1 patient. There was 1 case of arteriovenous fistula and another case of the LP docking button migrating into the pulmonary artery. There were also 115 non-LP retrieval patients after the advisory who received an additional pacemaker, with no adverse device-to-device interactions reported. As with standard pacers, LPs can have critical battery failures. Chronic retrieval of LPs is safe and efficacious. Copyright © 2017 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Survival rates of short (6 mm) micro-rough surface implants: a review of literature and meta-analysis.

PubMed

Srinivasan, Murali; Vazquez, Lydia; Rieder, Philippe; Moraguez, Osvaldo; Bernard, Jean-Pierre; Belser, Urs C

2014-05-01

The aim of this review was to test the hypothesis that 6 mm micro-rough short Straumann(®) implants provide predictable survival rates and verify that most failures occurring are early failures. A PubMed and hand search was performed to identify studies involving micro-rough 6-mm-short implants published between January 1987 and August 2011. Studies were included that (i) involve Straumann(®) 6 mm implants placed in the human jaws, (ii) provide data on the survival rate, (iii) mention the time of failure, and (iv) report a minimum follow-up period of 12 months following placement. A meta-analysis was performed on the extracted data. From a total of 842 publications that were screened, 12 methodologically sound articles qualified to be included for the statistical evaluation based on our inclusion criteria. A total of 690 Straumann(®) 6-mm-short implants were evaluated in the reviewed studies (Total: placed-690, failed-25; maxilla: placed-266, failed-14; mandible: placed-364, failed-5; follow-up period: 1-8 years). A meta-analysis was performed on the calculated early cumulative survival rates (CSR%). The pooled early CSR% calculated in this meta-analysis was 93.7%, whereas the overall survival rates in the maxilla and mandible were 94.7% and 98.6% respectively. Implant failures observed were predominantly early failures (76%). This meta-analysis provides robust evidence that micro-rough 6-mm-short dental implants are a predictable treatment option, providing favorable survival rates. The failures encountered with 6-mm-short implants were predominantly early and their survival in the mandible was slightly superior. © 2013 John Wiley & Sons A/S. Published by Blackwell Publishing Ltd.

Advances in sudden death prevention: the emerging role of a fully subcutaneous defibrillator.

PubMed

Majithia, Arjun; Estes, N A Mark; Weinstock, Jonathan

2014-03-01

Randomized clinical trials support the use of implantable defibrillators for mortality reduction in specific populations at high risk for sudden cardiac death. Conventional transvenous defibrillator systems are limited by implantation-associated complications, infection, and lead failure, which may lead to delivery of inappropriate shocks and diminish survival. The development of a fully subcutaneous defibrillator may represent a valuable addition to therapies targeted at sudden death prevention. The PubMed database was searched to identify all clinical reports of the subcutaneous defibrillator from 2000 to the present. We reviewed all case series, cohort analyses, and randomized trials evaluating the safety and efficacy of subcutaneous defibrillators. The subcutaneous defibrillator is a feasible development in sudden cardiac death therapy and may be useful particularly to extend defibrillator therapy to patients with complicated anatomy, limited vascular access, and congenital disease. The subcutaneous defibrillator should not be considered in patients with an indication for cardiac pacing or who have ventricular tachycardia responsive to antitachycardia pacing. Further investigation is needed to compare long-term, head-to-head performance of subcutaneous defibrillators and conventional transvenous defibrillator systems. Published by Elsevier Inc.

Appropriate evaluation and treatment of heart failure patients after implantable cardioverter-defibrillator discharge: time to go beyond the initial shock.

PubMed

Mishkin, Joseph D; Saxonhouse, Sherry J; Woo, Gregory W; Burkart, Thomas A; Miles, William M; Conti, Jamie B; Schofield, Richard S; Sears, Samuel F; Aranda, Juan M

2009-11-24

Multiple clinical trials support the use of implantable cardioverter-defibrillators (ICDs) for prevention of sudden cardiac death in patients with heart failure (HF). Unfortunately, several complicating issues have arisen from the universal use of ICDs in HF patients. An estimated 20% to 35% of HF patients who receive an ICD for primary prevention will experience an appropriate shock within 1 to 3 years of implant, and one-third of patients will experience an inappropriate shock. An ICD shock is associated with a 2- to 5-fold increase in mortality, with the most common cause being progressive HF. The median time from initial ICD shock to death ranges from 168 to 294 days depending on HF etiology and the appropriateness of the ICD therapy. Despite this prognosis, current guidelines do not provide a clear stepwise approach to managing these high-risk patients. An ICD shock increases HF event risk and should trigger a thorough evaluation to determine the etiology of the shock and guide subsequent therapeutic interventions. Several combinations of pharmacologic and device-based interventions such as adding amiodarone to baseline beta-blocker therapy, adjusting ICD sensitivity, and employing antitachycardia pacing may reduce future appropriate and inappropriate shocks. Aggressive HF surveillance and management is required after an ICD shock, as the risk of sudden cardiac death is transformed to an increased HF event risk.

Catheter-associated bloodstream infections in pediatric hematology-oncology patients: factors associated with catheter removal and recurrence.

PubMed

Adler, Amos; Yaniv, Isaac; Solter, Ester; Freud, Enrique; Samra, Zmira; Stein, Jerry; Fisher, Salvador; Levy, Itzhak

2006-01-01

The aims of this study were to analyze the factors associated with antibiotic failure leading to tunneled central venous catheter (CVC) removal during catheter-associated bloodstream infections (CABSIs) and with recurrence and reinfection in children with cancer. All cases of CABSI in patients attending the Department of Pediatric Hematology-Oncology between November 2000 and November 2003 were reviewed. A total of 207 episodes of CABSI, including multiple episodes involving the same catheter, were identified in 146 of 410 tunneled CVCs (167 Hickman, 243 implantable ports). The most common organism isolated was coagulase-negative Staphylococcus (CONS). The CVC was removed in 96 (46%) episodes. Hypotension, persistent bacteremia, previous stem cell transplantation, multiple CABSIs in the same CVC, exit-site infection, inappropriate empiric antibiotic therapy, and Candida infection were all significantly associated with increased risk of catheter removal (P < 0.05, odds ratios 7.81, 1.14, 2.22, 1.93, 3.04, 2.04 and 24.53, respectively). There were 12 episodes of recurrent infection, all except 1 caused by CONS (odds ratio 20.5, P = 0.006). Inappropriate empiric therapy, especially in implantable ports, was the only mutable risk factor for antibiotic failure. Because CONS was the predominant isolate in these devices, adding glycopeptides to the empiric therapy for suspected implantable-port CABSI might decrease the removal rate. This issue should be explored in future controlled trials.

Prefabricated Bar System for Immediate Loading in Edentulous Patients: A 5-Year Follow-Up Prospective Longitudinal Study

PubMed Central

Gherlone, Enrico F.; Rapanelli, Andrea; Crespi, Roberto; Gastaldi, Giorgio

2018-01-01

Objectives The aim of this clinical study was to evaluate a new type of prefabricated bar system, supported by axial and tilted implants at 5-year follow-up. Materials and Methods Twenty-nine consecutive participants (19 females, 10 males) (mean age 61.4 years), edentulous in one or both jaws, with severe atrophy of the posterior regions, were treated according to the All-on-four® protocol with immediately loaded axial (64) and tilted (64) implants supporting complete-arch screw-retained prostheses (12 maxillary, 20 mandibular) featuring a prefabricated bar as framework. Follow-up visits were performed at 3, 6, 12, 24, 48, and 60 months after implant insertion. Radiographic assessments were made using panoramic radiographs obtained immediately after surgery and at each follow-up visit. Bone level measurements around the axial and tilted implants were compared by means of the Student's t-test. Results One axial implant failed in the lower jaw and did not compromise prosthetic function. The 60-month overall implant survival rate was 100% for axially positioned implants and 98.44% for tilted implants. The implant survival rates were 100% in the maxilla and 98.75% in the mandible. None of the 32 fixed prostheses were lost during the observation period, representing a prosthetic survival rate of 100%. No statistically significant differences (P > 0.05) in marginal bone loss between tilted and axial implants were detected in either jaw over time. Conclusions The use of the evaluated prefabricated bar for immediately loaded implants placed according to the All-on-four concept may significantly reduce implant failures; however, more long-term prospective clinical trials are needed to affirm the effectiveness of the surgical-prosthetic protocol. PMID:29682552

Successful weaning of a left ventricular assist device implanted for ischemic heart failure.

PubMed

Beurtheret, Sylvain; Mordant, Pierre; Pavie, Alain; Leprince, Pascal

2010-10-01

We report the case of a patient stabilized under extra-corporeal membrane oxygenation after a refractory cardiogenic shock following myocardial infarction. Persistent left ventricular failure required secondary implantation of the left ventricular assist device (LVAD) HeartMate II. LVAD succeeded in the gradual recovery of myocardial contractility, allowing weaning of the device five months after implantation. Simultaneously, the patient beneficiated from coronary revascularization and resumed normal activity. This case emphasizes potential late recoveries after myocardial infarction complicated by left ventricular failure.

A prospective randomized multicenter trial comparing clinical outcomes of patients treated surgically with a static or dynamic implant for acute ankle syndesmosis rupture.

PubMed

Laflamme, Mélissa; Belzile, Etienne L; Bédard, Luc; van den Bekerom, Michel P J; Glazebrook, Mark; Pelet, Stéphane

2015-05-01

To compare the clinical and radiographic outcome after stabilization of an acute syndesmosis rupture with either a static implant (a 3.5-mm metallic screw through 4 cortices) or a dynamic device (TightRope; Arthrex). Multicenter randomized double-blind controlled trial. Study realized in 5 trauma centers (2 level 1 and 3 level 2) in 2 countries. Seventy subjects admitted for an acute ankle syndesmosis rupture entered the study and were randomized into 2 groups (dynamic fixation = 34 and static fixation = 36). The 2 groups were similar regarding demographic, social, and surgical data. Sixty-five patients (dynamic = 33 and static = 32) completed the study and were available for analysis. Syndesmosis fixation in the static group was realized with a 4 cortices 3.5-mm cortical screw (Synthes) and in the dynamic group with 1 TightRope (Arthrex). Standardized rehabilitation process for the 2 groups: no weight bearing in a cast for 6 weeks and then rehabilitation without protection. Olerud-Molander score. Subjects with dynamic fixation achieved better clinical performances as described with the Olerud-Molander scores at 3 (68.8 vs. 60.2, P = 0.067), 6 (84.2 vs. 76.8, P = 0.082), and 12 months (93.3 vs. 87.6, P = 0.046). We also observed higher American Orthopaedic Foot and Ankle Society scores at 3 months (78.6 vs. 70.6, P = 0.016), but these were not significant at 6 (87.1 vs. 83.8, P = 0.26) or 12 months (93.1 vs. 89.9, P = 0.26). Implant failure was higher in the screw group (36.1% vs. 0%, P < 0.05). Loss of reduction was observed in 4 cases in the static screw group (11.1% vs. 0%, P = 0.06). Dynamic fixation of acute ankle syndesmosis rupture with a dynamic device seems to result in better clinical and radiographic outcomes. The implant offers adequate syndesmotic stabilization without failure or loss of reduction, and the reoperation rate is significantly lower than with conventional screw fixation. Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Assessment of Various Risk Factors for Success of Delayed and Immediate Loaded Dental Implants: A Retrospective Analysis.

PubMed

Prasant, M C; Thukral, Rishi; Kumar, Sachin; Sadrani, Sannishth M; Baxi, Harsh; Shah, Aditi

2016-10-01

Ever since its introduction in 1977, a minimum of few months of period is required for osseointegration to take place after dental implant surgery. With the passage of time and advancements in the fields of dental implant, this healing period is getting smaller and smaller. Immediate loading of dental implants is becoming a very popular procedure in the recent time. Hence, we retrospectively analyzed the various risk factors for the failure of delayed and immediate loaded dental implants. In the present study, retrospective analysis of all the patients was done who underwent dental implant surgeries either by immediate loading procedure or by delayed loading procedures. All the patients were divided broadly into two groups with one group containing patients in which delayed loaded dental implants were placed while other consisted of patients in whom immediate loaded dental implants were placed. All the patients in whom follow-up records were missing and who had past medical history of any systemic diseases were excluded from the present study. Evaluation of associated possible risk factors was done by classifying the predictable factors as primary and secondary factors. All the results were analyzed by Statistical Package for the Social Sciences (SPSS) software. Kaplan-Meier survival analyses and chi-square test were used for assessment of level of significance. In delayed and immediate group of dental implants, mean age of the patients was 54.2 and 54.8 years respectively. Statistically significant results were obtained while comparing the clinical parameters of the dental implants in both the groups while demographic parameters showed nonsignificant correlation. Significant higher risk of dental implant failure is associated with immediate loaded dental implants. Tobacco smoking, shorter implant size, and other risk factors play a significant role in predicting the success and failure of dental implants. Delayed loaded dental implant placement should be preferred as they are associated with decreased risk of implant failure.

Is there a right place to pace the right ventricle? Evaluation of apical and septal positions in a pacemaker population: study protocol for a prospective intervention-control trial.

PubMed

Muto, Carmine; Calvi, Valeria; Botto, Giovanni Luca; Pecora, Domenico; Ciaramitaro, Gianfranco; Valsecchi, Sergio; Malacrida, Maurizio; Maglia, Giampiero

2014-11-01

The main objective of research in pacemaker therapy has been to provide the best physiologic way to pace the heart. Despite the good results provided by right ventricular pacing minimization and by biventricular pacing in specific subsets of heart failure patients, these options present many limitations for standard pacemaker recipients. In these patients, pacing the right ventricle at alternative sites could result in a lower degree of left intraventricular dyssynchrony. Despite the lack of strong evidence and the difficulty in placing and accurately classifying the final lead position, pacing at alternative right ventricular sites seems to have become a standard procedure at many implanting centers. The RIGHT PACE study is a multi-center, prospective, single-blind, double-arm, intervention-control trial comparing right ventricular pacing from the apex and from the septal site in terms of left intraventricular dyssynchrony. A total of 408 patients with indications for cardiac pacing but without indications for ICD and/or CRT will be enrolled. Investigators will be divided on the basis of their prior experience of selective site pacing lead implantation and patients will be treated according to the clinical practice of the centers. After device implantation, they will be followed up for 24 months through evaluation of clinical, echocardiographic and safety/system-performance variables. This study might provide important information about the impact of the right ventricular pacing on the left ventricular dyssynchrony, and about acute and chronic responses to selective site pacing, as adopted in current clinical practice. This trial is registered at ClinicalTrials.gov (ID:NCT01647490). Right Ventricular Lead Placement in a Pacemaker Population: Evaluation of apical and alternative position. ClinicalTrials.gov: NCT01647490. Copyright © 2014 Elsevier Inc. All rights reserved.

Long-Term Survival of Dental Implants with Different Prosthetic Loading Times in Healthy Patients: A 5-Year Retrospective Clinical Study.

PubMed

Muelas-Jiménez, M Isabel; Olmedo-Gaya, Maria Victoria; Manzano-Moreno, Francisco J; Reyes-Botella, Candela; Vallecillo-Capilla, Manuel

2017-02-01

To compare survival rates among dental implants restored with immediate, early, and conventional loading protocols, also comparing between maxillary and mandibular implants, and to evaluate the influence of implant length and diameter and the type of prosthesis on treatment outcomes. This retrospective cohort study initially included all 52 patients receiving dental implants between July 2006 and February 2008 at a private oral surgery clinic in Granada (Southern Spain). Clinical and radiographic examinations were performed, including periapical or panoramic radiographs, and incidences during completion of the restoration were recorded at 1 week, 3 months, 6 months, and at 1, 2, 3, 4, and 5 years. After a 5-year follow-up, 1 patient had died, 3 were lost to follow-up, and 6 required grafting before implant placement; therefore, the final study sample comprised 42 patients with 164 implants. Variables associated with the survival/failure of the restoration were: number of implants (higher failure rate with fewer implants), bone type (higher failure rate in type III or IV bone), and type of prosthesis (higher failure rate with single crowns). No significant association was found in univariate or multivariate analyses between survival rate and the loading protocol, implant length or diameter, or maxillary/mandibular location. Immediate occlusal loading, immediate provisionalization without occlusal loading, and early loading are viable treatment options with similar survival rates to those obtained with conventional loading. Bone quality and number of implants per patient were the most influential factors. © 2015 by the American College of Prosthodontists.

Gender-Related and Age-Related Differences in Implantable Defibrillator Recipients: Results From the Pacemaker and Implantable Defibrillator Leads Survival Study ("PAIDLESS").

PubMed

Feldman, Alyssa M; Kersten, Daniel J; Chung, Jessica A; Asheld, Wilbur J; Germano, Joseph; Islam, Shahidul; Cohen, Todd J

2015-12-01

The purpose of this study was to investigate the influences of gender and age on defibrillator lead failure and patient mortality. The specific influences of gender and age on defibrillator lead failure have not previously been investigated. This study analyzed the differences in gender and age in relation to defibrillator lead failure and mortality of patients in the Pacemaker and Implantable Defibrillator Leads Survival Study ("PAIDLESS"). PAIDLESS includes all patients at Winthrop University Hospital who underwent defibrillator lead implantation between February 1, 1996 and December 31, 2011. Male and female patients were compared within each age decile, beginning at 15 years old, to analyze lead failure and patient mortality. Statistical analyses were performed using Wilcoxon rank-sum test, Fisher's exact test, Kaplan-Meier analysis, and multivariable Cox regression models. P<.05 was considered statistically significant. No correction for multiple comparisons was performed for the subgroup analyses. A total of 3802 patients (2812 men and 990 women) were included in the analysis. The mean age was 70 ± 13 years (range, 15-94 years). Kaplan-Meier analysis found that between 45 and 54 years of age, leads implanted in women failed significantly faster than in men (P=.03). Multivariable Cox regression models were built to validate this finding, and they confirmed that male gender was an independent protective factor of lead failure in the 45 to 54 years group (for male gender: HR, 0.37; 95% confidence interval, 0.14-0.96; P=.04). Lead survival time for women in this age group was 13.4 years (standard error, 0.6), while leads implanted in men of this age group survived 14.7 years (standard error, 0.3). Although there were significant differences in lead failure, no differences in mortality between the genders were found for any ages or within each decile. This study is the first to compare defibrillator lead failure and patient mortality in relation to gender and age deciles at a single large implanting center. Within the 45 to 54 years group, leads implanted in women failed faster than in men. Male gender was found to be an independent protective factor in lead survival. This study emphasizes the complex interplay between gender and age with respect to implantable defibrillator lead failure and mortality.

Recovery of Serum Cholesterol Predicts Survival After Left Ventricular Assist Device Implantation

PubMed Central

Vest, Amanda R.; Kennel, Peter J.; Maldonado, Dawn; Young, James B.; Mountis, Maria M.; Naka, Yoshifumi; Colombo, Paolo C.; Mancini, Donna M.; Starling, Randall C.; Schulze, P. Christian

2017-01-01

Background Advanced systolic heart failure is associated with myocardial and systemic metabolic abnormalities, including low levels of total cholesterol and low-density lipoprotein. Low cholesterol and low-density lipoprotein have been associated with greater mortality in heart failure. Implantation of a left ventricular assist device (LVAD) reverses some of the metabolic derangements of advanced heart failure. Methods and Results A cohort was retrospectively assembled from 2 high-volume implantation centers, totaling 295 continuous-flow LVAD recipients with ≥2 cholesterol values available. The cohort was predominantly bridge-to-transplantation (67%), with median age of 59 years and 49% ischemic heart failure cause. Total cholesterol, low-density lipoprotein, high-density lipoprotein, and triglyceride levels all significantly increased after LVAD implantation (median values from implantation to 3 months post implantation 125–150 mg/dL, 67–85 mg/dL, 32–42 mg/dL, and 97–126 mg/dL, respectively). On Cox proportional hazards modeling, patients achieving recovery of total cholesterol levels, defined as a median or greater change from pre implantation to 3 months post-LVAD implantation, had significantly better unadjusted survival (hazard ratio, 0.445; 95% confidence interval, 0.212–0.932) and adjusted survival (hazard ratio, 0.241; 95% confidence interval, 0.092–0.628) than those without cholesterol recovery after LVAD implantation. The continuous variable of total cholesterol at 3 months post implantation and the cholesterol increase from pre implantation to 3 months were also both significantly associated with survival during LVAD support. Conclusions Initiation of continuous-flow LVAD support was associated with significant recovery of all 4 lipid variables. Patients with a greater increase in total cholesterol by 3 months post implantation had superior survival during LVAD support. PMID:27623768

A Comparative Study of Defibrillator Leads at a Large-Volume Implanting Hospital: Results From the Pacemaker and Implantable Defibrillator Leads Survival Study ("PAIDLESS").

PubMed

Cohen, Todd J; Asheld, Wilbur J; Germano, Joseph; Islam, Shahidul; Patel, Dhimesh

2015-06-01

The purpose of the study was to examine survival in the implantable defibrillator subset of implanted leads at a large-volume implanting hospital. Implantable lead survival has been the subject of many multicenter studies over the past decade. Fewer large implanting volume single-hospital studies have examined defibrillator lead failure as it relates to patient survival and lead construction. This investigator-initiated retrospective study examined defibrillator lead failure in those who underwent implantation of a defibrillator between February 1, 1996 and December 31, 2011. Lead failure was defined as: failure to capture/sense, abnormal pacing and/or defibrillator impedance, visual insulation defect or lead fracture, extracardiac stimulation, cardiac perforation, tricuspid valve entrapment, lead tip fracture and/or lead dislodgment. Patient characteristics, implant approach, lead manufacturers, lead models, recalled status, patient mortality, and core lead design elements were compared using methods that include Kaplan Meier analysis, univariate and multivariable Cox regression models. A total of 4078 defibrillator leads were implanted in 3802 patients (74% male; n = 2812) with a mean age of 70 ± 13 years at Winthrop University Hospital. Lead manufacturers included: Medtronic: [n = 1834; 801 recalled]; St. Jude Medical: [n = 1707; 703 recalled]; Boston Scientific: [n = 537; 0 recalled]. Kaplan-Meier analysis adjusted for multiple comparisons revealed that both Boston Scientific's and St. Jude Medical's leads had better survival than Medtronic's leads (P<.001 and P=.01, respectively). Lead survival was comparable between Boston Scientific and St. Jude Medical (P=.80). A total of 153 leads failed (3.5% of all leads) during the study. There were 99 lead failures from Medtronic (5.4% failure rate); 56 were recalled Sprint Fidelis leads. There were 36 lead failures from St. Jude (2.1% failure rate); 20 were recalled Riata or Riata ST leads. There were 18 lead failures from Boston Scientific (3.35% failure rate); none were recalled. Kaplan Meier analysis also showed lead failure occurred sooner in the recalled leads (P=.01). A total of 1493 patients died during the study (mechanism of death was largely unknown). There was a significant increase in mortality in the recalled lead group as compared with non-recalled leads (P=.01), but no significant difference in survival when comparing recalled leads from Medtronic with St. Jude Medical (P=.67). A multivariable Cox regression model revealed younger age, history of percutaneous coronary intervention, baseline rhythm other than atrial fibrillation or atrial flutter, combination polyurethane and silicone lead insulation, a second defibrillation coil, and recalled lead status all contributed to lead failure. This study demonstrated a significantly improved lead performance in the Boston Scientific and St. Jude leads as compared with Medtronic leads. Some lead construction variables (insulation and number of coils) also had a significant impact on lead failure, which was independent of the manufacturer. Recalled St. Jude leads performed better than recalled Medtronic leads in our study. Recalled St. Jude leads had no significant difference in lead failure when compared with the other manufacturer's non-recalled leads. Defibrillator recalled lead status was associated with an increased mortality as compared with non-recalled leads. This correlation was independent of the lead manufacturer and clinically significant even when considering known mortality risk factors. These results must be tempered by the largely unknown mechanism of death in these patients.

Electrical stimulation in the treatment of pain.

PubMed

Rushton, David N

2002-05-20

To review the published literature concerning the treatment of painful conditions using devices that deliver electrical stimulation to nervous structures. The review briefly surveys the results obtained using surface electrodes ("TENS") as well as implanted devices. The method used is a critical review of the important published literature up to mid-1999. References were obtained using Medline and the keywords "pain", together with "electrical", "stimulation", "neurostimulation" or "TENS". Electrical stimulation has been found to be of potential benefit in the management of a range of painful conditions. Adequately controlled trials of electrical stimulation are often difficult to achieve. Implanted devices tend to be used in the more severe intractable pain conditions. It is likely that there is more than one mechanism of action. The mechanisms of action are however still often poorly understood, even though historically theoretical and experimental advances in the understanding of pain mechanisms prompted the development of clinical systems and the institution of clinical studies. TENS has proved to be remarkably safe, and provides significant analgesia in about half of patients experiencing moderate predictable pain. Implanted devices can be more effective, but they carry a risk of device failure, implant infection or surgical complication, and are reserved for the more severe intractable chronic pains. The main implanted devices used clinically are the spinal cord stimulator and the deep brain stimulator.

In vitro evaluation of the torsional strength reduction of neonate calf metatarsal bones with Bicortical defects resulting from the removal of external fixation implants.

PubMed

Brianza, Stefano; Vogel, Susan; Rothstock, Stephan; Desrochers, Andrè; Boure, Ludovic

2013-01-01

To compare the torsional strength of calf metatarsal bones with defects produced by removal of 2 different implants. In vitro mechanical comparison of paired bones with bicortical defects resulting from the implantation of 2 different external fixation systems: the transfixation pin (TP) and the pin sleeve system (PS). Neonatal calf metatarsal bones (n = 6 pairs). From each pair, 1 bone was surgically instrumented with 2 PS implants and the contralateral bone with 2 TP implants. Implants were removed immediately leaving bicortical defects at identical locations between paired metatarsi. Each bone was tested in torque until failure. The mechanical variables statistically compared were the torsional stiffness, the torque and angle at failure, and work to failure. For TP and PS constructs, respectively, there were no significant differences between construct types for any of the variables tested. Mean ± SD torsional stiffness: 5.50 ± 2.68 and 5.35 ± 1.79 (Nm/°), P = .75; torque: 57.42 ± 14.84 and 53.43 ± 10.16 (Nm); P = .34; angle at failure: 14.76 ± 4.33 and 15.45 ± 4.84 (°), P = .69; and work to failure 7.45 ± 3.19 and 8.89 ± 3.79 (J), P = .17). Bicortical defects resulting from the removal of PS and TP implants equally affect the investigated mechanical properties of neonate calf metatarsal bones. © Copyright 2012 by The American College of Veterinary Surgeons.

[Implantable sensors for outpatient assessment of ventricular filling pressure in advanced heart failure : Which telemonitoring design is optimal?

PubMed

Herrmann, E; Fichtlscherer, S; Hohnloser, S H; Zeiher, A M; Aßmus, B

2016-12-01

Patients with advanced heart failure suffer from frequent hospitalizations. Non-invasive hemodynamic telemonitoring for assessment of ventricular filling pressure has been shown to reduce hospitalizations. We report on the right ventricular (RVP), the pulmonary artery (PAP) and the left atrial pressure (LAP) sensor for non-invasive assessment of the ventricular filling pressure. A literature search concerning the available implantable pressure sensors for noninvasive haemodynamic telemonitoring in patients with advanced heart failure was performed. Until now, only implantation of the PAP-sensor was able to reduce hospitalizations for cardiac decompensation and to improve quality of life. The right ventricular pressure sensor missed the primary endpoint of a significant reduction of hospitalizations, clinical data using the left atrial pressure sensor are still pending. The implantation of a pressure sensor for assessment of pulmonary artery filling pressure is suitable for reducing hospitalizations for heart failure and for improving quality of life in patients with advanced heart failure.

Neuropsychiatric symptoms following metal-on-metal implant failure with cobalt and chromium toxicity.

PubMed

Green, Ben; Griffiths, Emily; Almond, Solomon

2017-01-24

There were at least 31,171 metal-on-metal (MoM) hip implants in the UK between 2003 and 2011. Some of these were subject to failure and widescale recalls and revisions followed. This is a presentation of ten cases (mean age 60 years) where we evaluated neuropsychiatric morbidity following metal-on-metal hip implant failure and revision. Implants were ASR total hip replacement (acetabular implant, taper sleeve adaptor and unipolar femoral implants) performed between 2005 and 2009. This case series describes, for the first time, neuropsychiatric complications after revision where there has been cobalt and chromium toxicity. Pre-revision surgery, nine patients had toxic levels of chromium and cobalt (mean level chromium 338 nmol/l, mean cobalt 669.4 nmol/l). Depression assessment showed 9 of 9 respondents fulfilled the BDI criteria for depression and 3 of these were being treated. 7 of 9 patients showing short term memory deficit with mean mini mental state examination score of 24.2. The normal population mean MMSE for this group would be expected to be 28 with <25 indicating possible dementia. We found neurocognitive and depressive deficits after cobalt and chromium metallosis following MoM implant failure. Larger studies of neurocognitive effects are indicated in this group. There may be implications for public health.

Strength of titanium intramedullary implant versus miniplate fixation of mandibular condyle fractures.

PubMed

Frake, Paul C; Howell, Rebecca J; Joshi, Arjun S

2012-07-01

To test the strength of internal fixation of mandibular condyle fractures repaired with titanium miniplates versus titanium intramedullary implants. Prospective laboratory experimentation in urethane mandible models and human cadaveric mandibles. Materials testing laboratory at an academic medical center. Osteotomies of the mandibular condyle were created in 40 urethane hemimandible models and 24 human cadaveric specimens. Half of the samples in each group were repaired with traditional miniplates, and the other half were repaired with intramedullary titanium implants. Anteroposterior and mediolateral loads were applied to the samples, and the displacement was measured with reference to the applied force. Titanium intramedullary implants demonstrated statistically significant improved strength and stiffness versus miniplates in the urethane model experimental groups. Despite frequent plastic deformation and mechanical failures of the miniplates, a 1.6-mm-diameter titanium intramedullary pin did not mechanically fail in any of the cases. Intramedullary implantation failures were due to secondary fracture of the adjacent cortical bone or experimental design limitations including rotation of the smooth pin implant. Mechanical implant failures that were encountered with miniplate fixation were not seen with titanium intramedullary implants. These intramedullary implants provide stronger and more rigid fixation of mandibular condyle fractures than miniplates in this in vitro model.

Fracture of Reduced-Diameter Zirconia Dental Implants Following Repeated Insertion.

PubMed

Karl, Matthias; Scherg, Stefan; Grobecker-Karl, Tanja

Achievement of high insertion torque values indicating good primary stability is a goal during dental implant placement. The objective of this study was to evaluate whether or not two-piece implants made from zirconia ceramic may be damaged as a result of torque application. A total of 10 two-piece zirconia implants were repeatedly inserted into polyurethane foam material with increasing density and decreasing osteotomy size. The insertion torque applied was measured, and implants were checked for fractures by applying the fluorescent penetrant method. Weibull probability of failure was calculated based on the recorded insertion torque values. Catastrophic failures could be seen in five of the implants from two different batches at insertion torques ranging from 46.0 to 70.5 Ncm, while the remaining implants (all belonging to one batch) survived. Weibull probability of failure seems to be low at the manufacturer-recommended maximum insertion torque of 35 Ncm. Chipping fractures at the thread tips as well as tool marks were the only otherwise observed irregularities. While high insertion torques may be desirable for immediate loading protocols, zirconia implants may fracture when manufacturer-recommended insertion torques are exceeded. Evaluating bone quality prior to implant insertion may be useful.

Satisfaction and Clinical Outcomes Among Patients with Immediately Loaded Mandibular Overdentures Supported by One or Two Dental Implants: Results of a 5-Year Prospective Randomized Clinical Trial.

PubMed

Kronstrom, Mats; Davis, Ben; Loney, Robert; Gerrow, Jack; Hollender, Lars

The purpose of this study was to evaluate patient satisfaction and clinical outcomes among subjects with mandibular overdentures supported by one or two immediately placed dental implants 5 years after loading. Thirty-six subjects (16 men and 20 women) received one or two dental implants in the anterior mandible, and all implants were loaded the day of surgery. Subjects were scheduled for follow-up 3-, 6-, and 12 months after implant placement and thereafter annually for 4 more years. Patient satisfaction scores were measured with the Oral Health Impact Profile-EDENT (OHIPEDENT) questionnaire. Seventeen subjects (7 male and 10 female) with a mean age of 59.4 years (range, 44 to 74 years) were available for the 5-year follow-up examination. Nine subjects with 10 failing implants were excluded during the first year and nine subjects were lost to follow-up. No implants failed between the 12- and 60-month follow-up examinations, and the need for denture maintenance was low. Mean peri-implant bone change was 0.92 mm, and the Spearman test failed to show correlation between the insertion torque value and implant stability quotient. Patient satisfaction scores increased significantly when compared with baseline values and continued to be high for both groups, with no significant differences. Ten implants in nine subjects failed early, but no failures were observed after the 12-month examination. No significant differences were found between subjects in the two groups with respect to implant survival rates and peri-implant bone loss, and patient satisfaction scores continued to be high. Although patient satisfaction and implant success were high during the 12- to 60-month period, the results should be interpreted with caution because of the high number of failing implants and patients lost to follow-up. More research is needed to study outcomes of treatment with immediately loaded mandibular implant overdentures.

10-year prospective cohort follow-up of immediately restored XiVE implants.

PubMed

Degidi, Marco; Nardi, Diego; Piattelli, Adriano

2016-06-01

The aim of this prospective cohort study was to assess the ten-year performance of the condensing thread, self-tapping apex and internal hexagonal connection XiVE implant supporting partial fixed prostheses placed with an immediate restoration approach. All patients received a fixed two- to four-unit partial provisional restoration supported by immediately loaded implants. The final gold alloy/ceramic restorations were cemented approximately 28 weeks after implant insertion. Marginal bone level, pocket probing depth and percentage of bleeding on probing, biological or technical complications and any other adverse events were measured annually up to ten years after surgery. The overall success and survival rates at implant level were evaluated following the International Congress of Oral Implantologists (ICOI) Pisa Consensus Conference criteria. Implant placement in post-extractive or healed sites, smoking and a history of periodontal treatment were evaluated to assess whether they had an influence on bone resorption or on implant survival. Of 114 patients, for a total of 284 implants, fulfilled all the inclusion criteria and were enrolled in the study. 78 (27.5%) implants placed in 30 (26.3%) patients were lost to follow-up. Eight of 284 (2.8%) implants failed in 8 of 114 (7.0%) patients: one (12.5% of losses) due to failure to achieve osseointegration and seven (87.5% of losses) due to peri-implantitis. No cluster implant failures were assessed. The failure of the implant caused the failure of the prosthesis due to the strategic position of the implant in four patients. At the final ten-year follow-up, 121 (61.4%) implants exhibited a "full success" status with an optimal health condition, 21 (10.9%) implants scored a "satisfactory survival" condition, while 49 (25.49%) of the implants were classified as "compromised survival" status (Misch et al. 2008). Smoking was found to be statistically associated with "implant failure" (P = 0.010), while no association was found for patients treated for periodontal disease (P = 0.679) and post-extractive surgical sites (P = 0.664). Statistically significant more marginal bone loss was found in patients treated for periodontal disease (P < 0.0001). An increased bone loss was also observed in smokers, but the difference with the non-smokers was not statistically significant (P = 0.06). The XiVE implants can be successfully used to support immediate prosthesis. Patients with a history of periodontitis show increased bone loss and risk to develop peri-implant disease. Smoking seems to jeopardize the long-term implant survival. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A cloud-based home management system for patients with a left ventricular assist device: a case report.

PubMed

Nomoto, Shinichi; Utsumi, Momoe; Minakata, Kenji

2016-07-04

Since implantable left ventricular assist devices (LVAD) with smaller configurations became available for bridge-to-transplant or even destination therapy in patients with end-stage heart failure, an increasing number of patients with these devices are receiving home medical management. However, these patients may be anxious about potential complications such as pump failure, thromboembolism, and infections that may occur during home management. To provide a sense of security during home management of patients with LVAD and to establish an ideal shared-care system, we developed a patient-centered cloud-based home management system for patients with LVAD. In this case report, we describe this system and report a trial of it in a 64-year-old patient with an LVAD.

Impact of the right ventricular lead position on clinical outcome and on the incidence of ventricular tachyarrhythmias in patients with CRT-D.

PubMed

Kutyifa, Valentina; Bloch Thomsen, Poul Erik; Huang, David T; Rosero, Spencer; Tompkins, Christine; Jons, Christian; McNitt, Scott; Polonsky, Bronislava; Shah, Amil; Merkely, Bela; Solomon, Scott D; Moss, Arthur J; Zareba, Wojciech; Klein, Helmut U

2013-12-01

Data on the impact of right ventricular (RV) lead location on clinical outcome and ventricular tachyarrhythmias in cardiac resynchronization therapy with defibrillator (CRT-D) patients are limited. To evaluate the impact of different RV lead locations on clinical outcome in CRT-D patients enrolled in the Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy trial. We investigated 742 of 1089 CRT-D patients (68%) with adjudicated RV lead location enrolled in the Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy trial to evaluate the impact of RV lead location on cardiac events. The primary end point was heart failure or death; secondary end points included ventricular tachycardia (VT), ventricular fibrillation (VF), or death and VT or VF alone. Eighty-six patients had the RV lead positioned at the RV septal or right ventricular outflow tract region, combined as nonapical RV group, and 656 patients had apical RV lead location. There was no difference in the primary end point in patients with nonapical RV lead location versus those with apical RV lead location (hazard ratio [HR] 0.98; 95% confidence interval [CI] 0.54-1.80; P = .983). Echocardiographic response to CRT-D was comparable across RV lead location groups (P > .05 for left ventricular end-diastolic volume, left ventricular end-systolic volume, and left atrial volume percent change). However, nonapical RV lead location was associated with significantly higher risk of VT/VF/death (HR 2.45; 95% CI 1.36-4.41; P = .003) and VT/VF alone (HR 2.52; 95% CI 1.36-4.65; P = .002), predominantly in the first year after device implantation. Results were consistent in patients with left bundle branch block. In CRT-D patients, there is no benefit of nonapical RV lead location in clinical outcome or echocardiographic response. Moreover, nonapical RV lead location is associated with an increased risk of ventricular tachyarrhythmias, particularly in the first year after device implantation. Published by Elsevier Inc.

Expanded findings from a randomized controlled trial of preconception low-dose aspirin and pregnancy loss

PubMed Central

Mumford, Sunni L.; Silver, Robert M.; Sjaarda, Lindsey A.; Wactawski-Wende, Jean; Townsend, Janet M.; Lynch, Anne M.; Galai, Noya; Lesher, Laurie L.; Faraggi, David; Perkins, Neil J.; Schliep, Karen C.; Zarek, Shvetha M.; Schisterman, Enrique F.

2016-01-01

STUDY QUESTION What is the association between daily preconception-initiated low-dose aspirin (LDA) treatment and very early pregnancy losses or euploid (chromosomally normal) losses among women with one to two prior losses? SUMMARY ANSWER Daily LDA initiated preconception was not associated with the rate or type of pregnancy loss among women with a history of one to two prior pregnancy losses. WHAT IS KNOWN ALREADY LDA is often used to treat recurrent pregnancy loss with reductions in pregnancy loss generally only observed among women with antiphospholipid antibodies, and null associations observed among women without antiphospholipid antibodies. We previously evaluated the association between LDA and pregnancy loss overall among women with one to two prior losses in the Effects of Aspirin in Gestation and Reproduction (EAGeR) trial and found no association, though did not distinguish between potential effects at different stages of pregnancy loss, including implantation failure, or between euploid and aneuploid losses. STUDY DESIGN, SIZE, DURATION The EAGeR trial was a multi-site prospective block-randomized double-blind placebo-controlled trial. In total, 1228 women were randomized to daily LDA (81 mg/day) plus folic acid (400 mcg/day), or placebo plus folic acid. Participants were assigned study drug for less than or equal to six menstrual cycles or if they conceived, throughout pregnancy with study drug discontinued at 36 weeks gestation. This analysis includes additional outcome information obtained from chart abstractions after the completion of the trial, as well as testing of stored urine for measurement of hCG and detection of very early pregnancy losses, and karyotyping of the products of conception for assessment of aneuploidy of the losses. PARTICIPANTS, SETTING, METHODS Women aged 18–40 with a history of one to two prior losses and actively trying to conceive were randomized (n = 615 LDA and n = 613 placebo) at four clinical centers in the USA (2007–2011). Log-binomial regression was used to estimate risk ratios under the intent-to-treat approach. MAIN RESULTS AND THE ROLE OF CHANCE Daily LDA initiated preconception was not associated with clinically recognized pregnancy losses or implantation failures among women with proved fecundity and a history of one to two prior losses. Specifically, 1088 (88.6%) women completed the trial with 797 having an hCG detected pregnancy (64.9%). Overall there were 133 clinical losses (12.7% LDA versus 11.8% placebo, P = 0.71) and 55 implantation failures (5.2% LDA versus 4.9% placebo, P = 0.89). No differences were found in rate of euploid losses (RR 1.11, 95% confidence interval: 0.99, 1.26). LIMITATIONS, REASONS FOR CAUTION Generalizability of these findings is limited to women with a history of one to two prior losses, and may further be limited to women of white race with higher socioeconomic status as given the rigors of the study protocol participants tended to be white and have higher incomes and more education. We were also missing karyotype information on approximately one-third of the clinically recognized pregnancy losses, which may limit our power to detect effects on euploid losses, though detailed sensitivity analysis showed similar results. WIDER IMPLICATIONS OF THE FINDINGS Our data do not support the general use of LDA to decrease pregnancy loss and further demonstrate no increased risk of loss for women on LDA treatment. STUDY FUNDING/COMPETING INTERESTS This research was supported by the Intramural Research Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland (Contract Nos. HHSN267200603423, HHSN267200603424, HHSN267200603426). The authors have no conflicts of interest. TRIAL REGISTRATION NUMBER The trial was registered at ClinicalTrials.gov #NCT00467363. TRIAL REGISTRATION DATE 27 April 2007. DATE OF FIRST PATIENT'S ENROLLMENT 15 June 2007. PMID:26759138

Trabeculectomy with Ex-PRESS implant versus Ahmed glaucoma valve implantation-a comparative study

PubMed Central

Waisbourd, Michael; Fischer, Naomi; Shalev, Hadas; Spierer, Oriel; Ben Artsi, Elad; Rachmiel, Rony; Shemesh, Gabi; Kurtz, Shimon

2016-01-01

AIM To compare the surgical outcomes of trabeculectomy with Ex-PRESS implant and Ahmed glaucoma valve (AGV) implantation. METHODS Patients who underwent trabeculectomy with Ex-PRESS implants or AGV implantation separately were included in this retrospective chart review. Main outcome measures were surgical failure and complications. Failure was defined as intraocular pressure (IOP) >21 mm Hg or <5 mm Hg on two consecutive visits after 3mo, reoperation for glaucoma, or loss of light perception. Eyes that had not failed were considered as complete success if they did not required supplemental medical therapy. RESULTS A total of 64 eyes from 57 patients were included: 31 eyes in the Ex-PRESS group and 33 eyes in the AGV group. The mean follow-up time was 2.6±1.1y and 3.3±1.6y, respectively. Patients in the AGV group had significantly higher baseline mean IOP (P=0.005), lower baseline mean visual acuity (VA) (P=0.02), and higher proportion of patients with history of previous trabeculectomy (P<0.0001). Crude failure rates were 16.1%, n=5/31 in the Ex-PRESS group and 24.2%, n=8/33 in the AGV group. The cumulative proportion of failure was similar between the groups, P=0.696. The proportion of eyes that experienced postoperative complications was 32.3% in the Ex-PRESS group and 60.1% in the AGV group (P=0.0229). CONCLUSION Trabeculectomy with Ex-PRESS implant and AGV implantation had comparable failure rates. The AGV group had more post-operative complications, but also included more complex cases with higher baseline mean IOP, worse baseline mean VA, and more previous glaucoma surgeries. Therefore, the results are limited to the cohort included in this study. PMID:27803857

Rupture rate and patterns of shell failure with the McGhan Style 153 double-lumen breast implant.

PubMed

Neaman, Keith C; Albert, Mark; Hammond, Dennis C

2011-01-01

In 2005, the McGhan Style 153 double-lumen breast implant was removed from the market secondary to a higher rupture rate when contrasted with other implants in the Core Study group. The high rupture rate was attributed to the development of a posterior tear in the shell where the inner implant is bonded to the posterior wall of the device. The purpose of this study was to report the existing rupture rate and describe the apparent mechanism of failure in the Style 153 double-lumen breast implant. Ninety-seven patients (157 implants) who received the McGhan Style 153 double-lumen breast implant by the senior author were reviewed. Intraoperative observations and photographic images of ruptured implants were reviewed and characterized based on severity and location of implant rupture. With a mean length of follow-up of greater than 6 years (82 months), the rupture rate was 19.1 percent per implant. Physical examination (60 percent) was the most common method of rupture detection. Ruptures tended to occur in the marginal aspect (63 percent) of the implant. Only three ruptures occurred secondary to a disruption of the inner bladder from the posterior portion of the implant. The rupture rate of the Style 153 double-lumen breast implant is higher than previously thought, with a rate of 19.1 percent. A majority of ruptures occurred in the peripheral aspects of the implant. It is postulated that these ruptures were likely secondary to fold flaws that led to failure of the implant shell.

Histopathological characterization of corrosion product associated adverse local tissue reaction in hip implants: a study of 285 cases.

PubMed

Ricciardi, Benjamin F; Nocon, Allina A; Jerabek, Seth A; Wilner, Gabrielle; Kaplowitz, Elianna; Goldring, Steven R; Purdue, P Edward; Perino, Giorgio

2016-01-01

Adverse local tissue reaction (ALTR), characterized by a heterogeneous cellular inflammatory infiltrate and the presence of corrosion products in the periprosthetic soft tissues, has been recognized as a mechanism of failure in total hip replacement (THA). Different histological subtypes may have unique needs for longitudinal clinical follow-up and complication rates after revision arthroplasty. The purpose of this study was to describe the histological patterns observed in the periprosthetic tissue of failed THA in three different implant classes due to ALTR and their association with clinical features of implant failure. Consecutive patients presenting with ALTR from three major hip implant classes (N = 285 cases) were identified from our prospective Osteolysis Tissue Database and Repository. Clinical characteristics including age, sex, BMI, length of implantation, and serum metal ion levels were recorded. Retrieved synovial tissue morphology was graded using light microscopy. Clinical characteristics and features of synovial tissue analysis were compared between the three implant classes. Histological patterns of ALTR identified from our observations and the literature were used to classify each case. The association between implant class and histological patterns was compared. Our histological analysis demonstrates that ALTR encompasses three main histological patterns: 1) macrophage predominant, 2) mixed lymphocytic and macrophagic with or without features of associated with hypersensitivity/allergy or response to particle toxicity (eosinophils/mast cells and/or lymphocytic germinal centers), and 3) predominant sarcoid-like granulomas. Implant classification was associated with histological pattern of failure, and the macrophagic predominant pattern was more common in implants with metal-on-metal bearing surfaces (MoM HRA and MoM LHTHA groups). Duration of implantation and composition of periprosthetic cellular infiltrates was significantly different amongst the three implant types examined suggesting that histopathological features of ALTR may explain the variability of clinical implant performance in these cases. ALTR encompasses a diverse range of histological patterns, which are reflective of both the implant configuration independent of manufacturer and clinical features such as duration of implantation. The macrophagic predominant pattern and its mechanism of implant failure represent an important subgroup of ALTR which could become more prominent with increased length of implantation.

A Retrospective Analysis of Dental Implants Replacing Failed Implants in Grafted Maxillary Sinus: A Case Series.

PubMed

Manor, Yifat; Chaushu, Gavriel; Lorean, Adi; Mijiritzky, Eithan

2015-01-01

To evaluate the survival rate of dental implants replacing failed implants in grafted maxillary sinuses using the lateral approach vs nongrafted posterior maxillae. A retrospective analysis was conducted to study the survival of secondary dental implants inserted in the posterior maxilla in previously failed implant sites between the years 2000 and 2010. The study group consisted of patients who had also undergone maxillary sinus augmentation, and the control group consisted of patients in whom implants in the posterior maxilla had failed. Clinical and demographic data were analyzed using a structured form. Seventy-five patients with a total of 75 replaced implants were included in the study. The study group comprised 40 patients and the control group, 35 patients. None of the replaced implants in the study group failed, resulting in an overall survival of 100%; three replaced implants in the control group failed (92% survival). The main reason for the primary implant removal was lack of osseointegration (35 [87.5%] of 40 study group implants and 23 [65.7%] of 35 control group implants [P = .027]). The difference between the groups with regard to the timing of primary implant failure was statistically significant. The study group had more early failures of the primary implant than did the control group (77% vs 62%; P = .038). Dental implants replaced in the posterior maxilla had a high survival rate. A higher rate of survival was found in augmented maxillary sinus sites. Within the limits of the present study, it can be concluded that previous implant failures in the grafted maxillary sinus should not discourage practitioners from a second attempt.

The impact of proximal femoral morphology on failure strength with a mid-head resection short-stem hip arthroplasty.

PubMed

Olsen, Michael; Al Saied, Mohamed; Morison, Zachary; Sellan, Michael; Waddell, James P; Schemitsch, Emil H

2014-12-01

Mid-head resection short-stem hip arthroplasty is a conservative alternative to conventional total hip replacement and addresses proximal fixation challenges in patients not suitable for hip resurfacing. It is unclear whether proximal femoral morphology impacts the ultimate failure load of mid-head resection implanted femurs, thus the aim of this study was to investigate the effect of native neck-shaft angle (NSA) and coronal implant alignment on proximal femoral strength. In total, 36 synthetic femurs with two different proximal femoral morphologies were utilized in this study. Of them, 18 femurs with a varus NSA of 120° and 18 femurs with a valgus NSA of 135° were each implanted with a mid-head resection prosthesis. Femurs within the two different femoral morphology groups were divided into three equal coronal implant alignment groups: 10° valgus, 10° varus or neutral alignment. Prepared femurs were tested for stiffness and to failure in axial compression. There was no significant difference in stiffness nor failure load between femurs implanted with valgus-, varus- or neutrally aligned implants in femurs with a NSA of 120° (p = 0.396, p = 0.111, respectively). Femurs implanted in valgus orientation were significantly stiffer and failed at significantly higher loads than those implanted in varus alignment in femurs with a NSA of 135° (p = 0.001, p = 0.007, respectively). A mid-head resection short-stem hip arthroplasty seems less sensitive to clinically relevant variations of coronal implant alignment and may be more forgiving upon implantation in some femoral morphologies, however, a relative valgus component alignment is recommended. © IMechE 2014.

Rationale, design, and baseline characteristics of the DANish randomized, controlled, multicenter study to assess the efficacy of Implantable cardioverter defibrillators in patients with non-ischemic Systolic Heart failure on mortality (DANISH).

PubMed

Thune, Jens Jakob; Pehrson, Steen; Nielsen, Jens Cosedis; Haarbo, Jens; Videbæk, Lars; Korup, Eva; Jensen, Gunnar; Hildebrandt, Per; Steffensen, Flemming Hald; Bruun, Niels Eske; Eiskjær, Hans; Brandes, Axel; Thøgersen, Anna Margrethe; Egstrup, Kenneth; Hastrup-Svendsen, Jesper; Høfsten, Dan Eik; Torp-Pedersen, Christian; Køber, Lars

2016-09-01

The effect of an implantable cardioverter defibrillator (ICD) in patients with symptomatic systolic heart failure (HF) caused by coronary artery disease is well documented. However, the effect of primary prophylactic ICDs in patients with systolic HF not due to coronary artery disease is much weaker. In addition, HF management has improved, since the landmark ICD trials and a large proportion of patients now receive cardiac resynchronization therapy (CRT) where the effect of ICD treatment is unknown. In the DANISH study, 1,116 patients with symptomatic systolic HF not caused by coronary artery disease have been randomized to receive an ICD or not, in addition to contemporary standard therapy. The primary outcome of the trial is time to all-cause death. Follow-up will continue until June 2016 with a median follow-up period of 5 years. Baseline characteristics show that enrolled patients are treated according to current guidelines. At baseline, 97% of patients received an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, 92% received a β-blocker, 58% a mineralocorticoid receptor antagonist, and 58% were scheduled to receive CRT. Median age was 63 years (range, 21-84 years) at baseline, and 28% were women. DANISH will provide pertinent information about the effect on all-cause mortality of a primary prophylactic ICD in patients with symptomatic systolic HF not caused by coronary artery disease on contemporary standard therapy including CRT. Copyright © 2016 Elsevier Inc. All rights reserved.

Recent advances in heart failure.

PubMed

Kassi, Mahwash; Hannawi, Bashar; Trachtenberg, Barry

2018-03-01

Acute heart failure continues to be a challenge as there is limited benefit of numerous agents that have been tested. Cardiac resynchronization therapy remains standard of care, yet timing and need for implantable cardiac defibrillator has been brought into question with the recent randomized trials. Several recent advances have been made towards management of heart failure both in drug and device therapy. The purpose of this review is to provide an update on the most important recent studies on heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF). Two new drugs have been added to the armamentarium for HFrEF; ivabradine and angiotensin receptor-neprilysin inhibitors (ARNIs). Initial data from a new left ventricular assist device (LVAD) pump, the HeartMate 3 (HM III), have demonstrated no reports of pump thrombosis at 6 months, but stroke and right ventricle failure continue to be a challenge with comparable rates compared with the HeartMate II. Several large studies in HFpEF failed to show improvement in outcomes and management continues to be geared towards lifestyle modification and symptom relief. Newer therapies and devices have met with great success, yet there are several therapies that provide no benefit and even harm. A careful review of the recent literature remains instrumental to the effective management of patients with heart failure.

Regenerative Surgical Treatment of Peri-implantitis

ClinicalTrials.gov

2016-08-31

Failure of Dental Implant Due to Infection; Infection; Inflammation; Peri-implantitis; Bacterial Infections; Bleeding of Subgingival Space; Molecular Sequence Variation; Periodontal Diseases; Mouth Diseases

Sacubitril/Valsartan in Clinical Practice: A Report of 2 Cases.

PubMed

Cosentino, Eugenio

Following the results of the PARADIGM-HF trial, the European Society of Cardiology (ESC) guidelines recommend sacubitril/valsartan to replace ACE inhibitors in ambulatory patients with heart failure with reduced ejection fraction (HFrEF) who remain symptomatic despite optimal therapy and who fit trial criteria. However, the optimal use of sacubitril/valsartan in clinical practice needs further investigation. We report here the cases of 2 patients with HFrEH successfully treated with sacubitril/valsartan in our daily practice. Both subjects presented multiple comorbidities and received an implantable cardioverter defibrillator in primary prevention. In both patients, therapy with sacubitril/valsartan led to prompt (30 days) amelioration of heart function, with a corresponding decrease in NHYA class and without any relevant safety issue. © 2017 S. Karger AG, Basel.

Acute Autonomic Engagement Assessed by Heart Rate Dynamics During Vagus Nerve Stimulation in Patients With Heart Failure in the ANTHEM-HF Trial.

PubMed

Nearing, Bruce D; Libbus, Imad; Amurthur, Badri; Kenknight, Bruce H; Verrier, Richard L

2016-09-01

Chronic vagus nerve stimulation (VNS) applied to produce biomimetic levels of parasympathetic activation is feasible, well tolerated, safe, improves left ventricular ejection fraction, NYHA class, heart rate variability, and baroreflex function, and reduces T-wave alternans (TWA) in patients with chronic heart failure. However, the acute effects of VNS on beat-to-beat heart rate dynamics have not been systematically characterized in humans. We evaluated acute effects of VNS on R-R-interval dynamics during the VNS titration period in patients (n = 59) enrolled in ANTHEM-HF trial by quantifying effects during continuous cyclic VNS (14-seconds on-time, 66-seconds off-time) adjusted to the maximum tolerable dose without excessive (<4 bpm) bradycardia during the 10-week titration period. VNS elicited an immediate change in heart rate that was correlated to VNS current amplitude, pulse width, and frequency. Heart rate decreased more in the 28 patients with right-sided stimulation (-2.22 ± 0.13 bpm) than in the 31 patients with left-sided stimulation (-0.60 ± 0.08 bpm, P < 0.001). The linear correlation between stimulus intensity and lengthening of the R-R interval was stronger among the 28 patients with right-sided VNS implantation (r = 0.88, P < 0.0001) than among the 31 patients with left-sided VNS implantation (r = 0.49, P < 0.002). In all patients, the heart rate change elicited by VNS was significantly greater than the change during the same timing intervals in 10 randomly selected patients without stimulation (+0.08 ± 0.06 bpm, P < 0.001). Instantaneous heart rate change during therapeutic levels of VNS in patients with heart failure indicates consistent modulation of the autonomic nervous system for both left- and right-sided stimulation. © 2016 The Authors. Journal of Cardiovascular Electrophysiology published by Wiley Periodicals, Inc.

Biomaterial-host interactions: consequences, determined by implant retrieval analysis.

PubMed

Kaplan, S S

1994-01-01

Prosthetic biomaterials have had a profound impact on reconstructive surgery but complete biocompatability remains illusive. This review considers the retrieval analysis of four common prosthetic structures: the hip, the knee, heart valves, and blood vessels. We show that despite a fine record of early success, deterioration due to mechanical failure or deleterious host responses to the implant may compromise long term function. The eventual retrieval and detailed analysis of implanted structures provides an invaluable opportunity to determine the characteristics of implant success or failure and to provoke the development of still better materials.

Cardiac-resynchronization therapy in heart failure with a narrow QRS complex.

PubMed

Ruschitzka, Frank; Abraham, William T; Singh, Jagmeet P; Bax, Jeroen J; Borer, Jeffrey S; Brugada, Josep; Dickstein, Kenneth; Ford, Ian; Gorcsan, John; Gras, Daniel; Krum, Henry; Sogaard, Peter; Holzmeister, Johannes

2013-10-10

Cardiac-resynchronization therapy (CRT) reduces morbidity and mortality in chronic systolic heart failure with a wide QRS complex. Mechanical dyssynchrony also occurs in patients with a narrow QRS complex, which suggests the potential usefulness of CRT in such patients. We conducted a randomized trial involving 115 centers to evaluate the effect of CRT in patients with New York Heart Association class III or IV heart failure, a left ventricular ejection fraction of 35% or less, a QRS duration of less than 130 msec, and echocardiographic evidence of left ventricular dyssynchrony. All patients underwent device implantation and were randomly assigned to have CRT capability turned on or off. The primary efficacy outcome was the composite of death from any cause or first hospitalization for worsening heart failure. On March 13, 2013, the study was stopped for futility on the recommendation of the data and safety monitoring board. At study closure, the 809 patients who had undergone randomization had been followed for a mean of 19.4 months. The primary outcome occurred in 116 of 404 patients in the CRT group, as compared with 102 of 405 in the control group (28.7% vs. 25.2%; hazard ratio, 1.20; 95% confidence interval [CI], 0.92 to 1.57; P=0.15). There were 45 deaths in the CRT group and 26 in the control group (11.1% vs. 6.4%; hazard ratio, 1.81; 95% CI, 1.11 to 2.93; P=0.02). In patients with systolic heart failure and a QRS duration of less than 130 msec, CRT does not reduce the rate of death or hospitalization for heart failure and may increase mortality. (Funded by Biotronik and GE Healthcare; EchoCRT ClinicalTrials.gov number, NCT00683696.).

Usefulness of Tricuspid Annular Diameter to Predict Late Right Sided Heart Failure in Patients With Left Ventricular Assist Device.

PubMed

Nakanishi, Koki; Homma, Shunichi; Han, Jiho; Takayama, Hiroo; Colombo, Paolo C; Yuzefpolskaya, Melana; Garan, Arthur R; Farr, Maryjane A; Kurlansky, Paul; Di Tullio, Marco R; Naka, Yoshifumi; Takeda, Koji

2018-07-01

Although late-onset right-sided heart failure is recognized as a clinical problem in the treatment of patients with left ventricular assist devices (LVADs), the mechanism and predictors are unknown. Tricuspid valve (TV) deformation leads to the restriction of the leaflet motion and decreased coaptation, resulting in a functional tricuspid regurgitation that may act as a surrogate marker of late right-sided heart failure. This study aimed to investigate the association of preoperative TV deformation (annulus dilatation and leaflet tethering) with late right-sided heart failure development after continuous-flow LVAD implantation. The study cohort consisted of 274 patients who underwent 2-dimensional echocardiography before LVAD implantation. TV annulus diameter and tethering distance were measured in an apical 4-chamber view. Late right-sided heart failure was defined as right-sided heart failure requiring readmission and medical and/or surgical treatment after initial LVAD implantation. During a mean follow-up of 25.1 ± 19.0 months after LVAD implantation, late right-sided heart failure occurred in 33 patients (12.0%). Multivariate Cox proportional hazard analysis demonstrated that TV annulus diameter (hazard ratio 1.221 per 1 mm, p <0.001) was significantly associated with late right-sided heart failure development, whereas leaflet tethering distance was not. The best cut-off value of the TV annular diameter was 41 mm (area under the curve 0.787). Kaplan-Meier analysis showed that patients with dilated TV annulus (TV annular diameter ≥41 mm) exhibited a significantly higher late right-sided heart failure occurrence than those without TV annular enlargement (log-rank p <0.001). In conclusion, preoperative TV annulus diameter, but not leaflet tethering distance, predicted the occurrence of late right-sided heart failure after LVAD implantation. Copyright © 2018 Elsevier Inc. All rights reserved.

Does Bruxism Contribute to Dental Implant Failure? A Systematic Review and Meta-Analysis.

PubMed

Zhou, Yi; Gao, Jinxia; Luo, Le; Wang, Yining

2016-04-01

Bruxism was usually considered as a contraindication for oral implanting. The causal relationship between bruxism and dental implant failure was remained controversial in existing literatures. This meta-analysis was performed to investigate the relationship between them. This review conducted an electronic systematic literature search in MEDLINE (PubMed) and EmBase in November 2013 without time and language restrictions. Meanwhile, a hand searching for all the relevant references of included studies was also conducted. Study information extraction and methodological quality assessments were accomplished by two reviewers independently. A discussion ensued if any disagreement occurred, and unresolved issues were solved by consulting a third reviewer. Methodological quality was assessed by using the Newcastle-Ottawa Scale tool. Odds ratio (OR) with 95% confidence interval (CI) was pooled to estimate the relative effect of bruxism on dental implant failures. Fixed effects model was used initially; if the heterogeneity was high, random effects model was chosen for meta-analysis. Statistical analyses were carried out by using Review Manager 5.1. In this meta-analysis review, extracted data were classified into two groups based on different units. Units were based on the number of prostheses (group A) and the number of patients (group B). In group A, the total pooled OR of bruxers versus nonbruxers for all subgroups was 4.72 (95% CI: 2.66-8.36, p = .07). In group B, the total pooled OR of bruxers versus nonbruxers for all subgroups was 3.83 (95% CI: 2.12-6.94, p = .22). This meta-analysis was performed to evaluate the relationship between bruxism and dental implant failure. In contrast to nonbruxers, prostheses in bruxers had a higher failure rate. It suggests that bruxism is a contributing factor of causing the occurrence of dental implant technical/biological complications and plays a role in dental implant failure. © 2015 Wiley Periodicals, Inc.

Cardiac-resynchronization therapy for mild-to-moderate heart failure.

PubMed

Tang, Anthony S L; Wells, George A; Talajic, Mario; Arnold, Malcolm O; Sheldon, Robert; Connolly, Stuart; Hohnloser, Stefan H; Nichol, Graham; Birnie, David H; Sapp, John L; Yee, Raymond; Healey, Jeffrey S; Rouleau, Jean L

2010-12-16

Cardiac-resynchronization therapy (CRT) benefits patients with left ventricular systolic dysfunction and a wide QRS complex. Most of these patients are candidates for an implantable cardioverter-defibrillator (ICD). We evaluated whether adding CRT to an ICD and optimal medical therapy might reduce mortality and morbidity among such patients. We randomly assigned patients with New York Heart Association (NYHA) class II or III heart failure, a left ventricular ejection fraction of 30% or less, and an intrinsic QRS duration of 120 msec or more or a paced QRS duration of 200 msec or more to receive either an ICD alone or an ICD plus CRT. The primary outcome was death from any cause or hospitalization for heart failure. We followed 1798 patients for a mean of 40 months. The primary outcome occurred in 297 of 894 patients (33.2%) in the ICD-CRT group and 364 of 904 patients (40.3%) in the ICD group (hazard ratio in the ICD-CRT group, 0.75; 95% confidence interval [CI], 0.64 to 0.87; P<0.001). In the ICD-CRT group, 186 patients died, as compared with 236 in the ICD group (hazard ratio, 0.75; 95% CI, 0.62 to 0.91; P = 0.003), and 174 patients were hospitalized for heart failure, as compared with 236 in the ICD group (hazard ratio, 0.68; 95% CI, 0.56 to 0.83; P<0.001). However, at 30 days after device implantation, adverse events had occurred in 124 patients in the ICD-CRT group, as compared with 58 in the ICD group (P<0.001). Among patients with NYHA class II or III heart failure, a wide QRS complex, and left ventricular systolic dysfunction, the addition of CRT to an ICD reduced rates of death and hospitalization for heart failure. This improvement was accompanied by more adverse events. (Funded by the Canadian Institutes of Health Research and Medtronic of Canada; ClinicalTrials.gov number, NCT00251251.).

Retrospective analysis of reasons for failure of DDD pacemaker implantation in patients operated on between 1993 and 2005.

PubMed

Lelakowski, Jacek; Majewski, Jacek; Małecka, Barbara; Bednarek, Jacek; Stypuła, Paweł; Szeglowski, Marcin

2007-01-01

During implantation of a DDD pacemaker the following difficulties may be encountered: venous anomalies (the absence of vessels of adequate calibre or difficulty in subclavian vein puncture), arrhythmias during implantation (episodes of atrial flutter/fibrillation while the atrial leads are being positioned), lack of mechanical stability of the electrode in the heart chamber and inability to achieve an acceptable pacing and sensing threshold during implantation. The purpose of the study was to analyse retrospectively the reasons for DDD pacemaker failure in patients operated on between 1993 and 2005. We reviewed retrospectively all implantation data from 1988 to 2005 to identify patients with primary failure of DDD pacemaker implantation. Further analysis included patients who had received a DDD pacemaker between 1993 and 2005, when this type of pacemaker made up between 9 and 40% of all pacemaker implantations. We implanted 7469 pacemakers, including 1958 (26.2%) dual-chamber pacemakers, in 783 patients with atrioventricular block (AVB), 392 with sick sinus syndrome (SSS), 450 with AVB +/- SSS and 333 with tachy-brady syndrome (TBS). The mean age of the patients was 65.5 +/- 17.3 years. DDD pacing was unsuccessful in 108 (1.4%) patients, including 32 with AVB, 22 with SSS, 16 with SSS +/- AVB and 38 with TBS. The mean age of these patients was 78.5 +/- 19.4 years. The reasons for failed implantation were venous anomalies in 12%, an arrhythmia episode in 27.8%, a high pacing threshold in the atrium in 17.6%, low atrial potential amplitude in 25.9% and lack of mechanical stability of the electrode in 16.7% of patients. The difficulties were encountered in elderly patients (p < 0.01), most frequently in patients with SSS and TBS (71). Between 2004 and 2005 venous anomalies and a high pacing threshold were the main causes of failure. Currently the main difficulties encountered during pacemaker implantation are venous anomalies and a high pacing threshold. Arrhythmia episodes, low atrial potential amplitude and lack of mechanical stability are of minor importance. Elderly patients with sick sinus syndrome and tachy-brady syndrome have the highest failure rate. (Cardiol J 2007; 14: 155-159).

Prospective Observational Study of Implantable Cardioverter‐Defibrillators in Primary Prevention of Sudden Cardiac Death: Study Design and Cohort Description

PubMed Central

Cheng, Alan; Dalal, Darshan; Butcher, Barbara; Norgard, Sanaz; Zhang, Yiyi; Dickfeld, Timm; Eldadah, Zayd A.; Ellenbogen, Kenneth A.; Guallar, Eliseo; Tomaselli, Gordon F.

2013-01-01

Background Primary‐prevention implantable cardioverter‐defibrillators (ICDs) reduce total mortality in patients with severe left ventricular systolic function. However, only a minority of patients benefit from these devices. We designed the Prospective Observational Study of Implantable Cardioverter‐Defibrillators (PROSE‐ICD) to identify risk factors and enhance our understanding of the biological mechanisms that predispose to arrhythmic death in patients undergoing ICD implantation for primary prevention of sudden death. Methods and Results This is a multicenter prospective cohort study with a target enrollment of 1200 patients. The primary end point is ICD shocks for adjudicated ventricular tachyarrhythmias. The secondary end point is total mortality. All patients undergo a comprehensive evaluation including history and physical examination, signal‐averaged electrocardiograms, and blood sampling for genomic, proteomic, and metabolomic analyses. Patients are evaluated every 6 months and after every known ICD shock for additional electrocardiographic and blood sampling. As of December 2011, a total of 1177 patients have been enrolled with more nonwhite and female patients compared to previous randomized trials. A total of 143 patients have reached the primary end point, whereas a total of 260 patients died over an average follow‐up of 59 months. The PROSE‐ICD study represents a real‐world cohort of individuals with systolic heart failure receiving primary‐prevention ICDs. Conclusions Extensive electrophysiological and structural phenotyping as well as the availability of serial DNA and serum samples will be important resources for evaluating novel metrics for risk stratification and identifying patients at risk for arrhythmic sudden death. Clinical Trial Registration URL: http://clinicaltrials.gov/ Unique Identifier: NCT00733590. PMID:23525420

Cost effectiveness of different central venous approaches for port placement and use in adult oncology patients: evidence from a randomized three-arm trial.

PubMed

Biffi, Roberto; Pozzi, Simonetta; Bonomo, Guido; Della Vigna, Paolo; Monfardini, Lorenzo; Radice, Davide; Rotmensz, Nicole; Zampino, Maria Giulia; Fazio, Nicola; Orsi, Franco

2014-11-01

No randomized trials have so far investigated the cost effectiveness of different methods for implantation and use of central venous ports in oncology patients. Overall, 403 patients eligible for receiving intravenous chemotherapy for solid tumours were randomly assigned to implantation of a single type of port, either through a percutaneous landmark access to the internal jugular vein, an ultrasound (US)-guided access to the subclavian vein, or a surgical cut-down access through the cephalic vein at the deltoid-pectoralis groove. Insertion and maintenance costs were estimated by obtaining the charges for an average implant and use, while the costs of the management of complications were analytically assessed. The total cost was defined as the purchase cost plus the insertion cost plus the maintenance cost plus the cost of treatment of the complications, if any. A total of 401 patients were evaluable-132 with the internal jugular vein, 136 with the subclavian vein and 133 with the cephalic vein access. No differences were found for the rate of early complications. The US-guided subclavian insertion site had significantly lower failures. Infections occurred in 1, 3, and 3 patients (internal jugular, subclavian, and cephalic access, respectively; p = 0.464), whereas venous thrombosis was observed in 15, 8, and 11 patients, respectively (p = 0.272). Mean cost for purchase, implantation, diagnosis and treatment of complications in each patient was 2,167.85 for subclavian US-guided, 2,335.87 for cephalic, and 2,384.10 for internal jugular access, respectively (p = 0.0001). US real-time guidance to the subclavian vein resulted in the most cost-effective method of central venous port placement and use.

Evaluation of the Etiologies of Implant Fracture in Patients With Fractures of the Implants of Lower Limbs’ Long Bones

PubMed Central

Yeganeh, Ali; Otoukesh, Babak; Kaghazian, Peyman; Yeganeh, Nima; Boddohi, Bahram; Moghtadaei, Mehdi

2015-01-01

Background: Orthopedics implants are important tools for treatment of bone fractures. Despite available recommendations for designing and making the implants, there are multiple cases of fracture of these implants in the body. Hence, in this study the frequency of failure of implants in long bones of lower extremities was evaluated. Methods and Materials: In this cross-sectional study, two types of fractured implants in the body were analyzed and underwent metalogical, mechanical, and modeling and stress-bending analysis. Results: The results revealed that the main cause of fractures was decreased mechanical resistance due to inappropriate chemical composition (especially decreased percentages of Nickel and Molybdenum). Conclusions: It may be concluded that following the standard chemical composition and use of optimal making method are the most important works for prevention of failure of implants. PMID:26843735

Reconstruction of the Irradiated Breast: A National Claims-Based Assessment of Postoperative Morbidity.

PubMed

Chetta, Matthew D; Aliu, Oluseyi; Zhong, Lin; Sears, Erika D; Waljee, Jennifer F; Chung, Kevin C; Momoh, Adeyiza O

2017-04-01

Implant-based reconstruction rates have risen among irradiation-treated breast cancer patients in the United States. This study aims to assess the morbidity associated with various breast reconstruction techniques in irradiated patients. From the MarketScan Commercial Claims and Encounters database, the authors selected breast cancer patients who had undergone mastectomy, irradiation, and breast reconstruction from 2009 to 2012. Demographic and clinical treatment data, including data on the timing of irradiation relative to breast reconstruction were recorded. Complications and failures after implant and autologous reconstruction were also recorded. A multivariable logistic regression model was developed with postoperative complications as the dependent variable and patient demographic and clinical variables as independent variables. Four thousand seven hundred eighty-one irradiated patients who met the inclusion criteria were selected. A majority of the patients [n = 3846 (80 percent)] underwent reconstruction with implants. Overall complication rates were 45.3 percent and 30.8 percent for patients with implant and autologous reconstruction, respectively. Failure of reconstruction occurred in 29.4 percent of patients with implant reconstruction compared with 4.3 percent of patients with autologous reconstruction. In multivariable logistic regression, irradiated patients with implant reconstruction had two times the odds of having any complication and 11 times the odds of failure relative to patients with autologous reconstruction. Implant-based breast reconstruction in the irradiated patient, although popular, is associated with significant morbidity. Failures of reconstruction with implants in these patients approach 30 percent in the short term, suggesting a need for careful shared decision-making, with full disclosure of the potential morbidity. Therapeutic, III.

Remote monitoring to Improve long-term prognosis in heart failure patients with implantable cardioverter-defibrillators.

PubMed

Ono, Maki; Varma, Niraj

2017-05-01

Strong evidence exists for the utility of remote monitoring in cardiac implantable electronic devices for early detection of arrhythmias and evaluation of system performance. The application of remote monitoring for the management of chronic disease such as heart failure has been an active area of research. Areas covered: This review aims to cover the latest evidence of remote monitoring of implantable cardiac defibrillators in terms of heart failure prognosis. This article also updates the current technology relating to the method and discusses key factors to be addressed in order to better use the approach. PubMed and internet searches were conducted to acquire most recent data and technology information. Expert commentary: Multiparameter monitoring with automatic transmission is useful for heart failure management. Improved adherence to remote monitoring and an optimal algorithm for transmitted alerts and their management are warranted in the management of heart failure.

A Comparative Finite-Element Analysis of Bone Failure and Load Transfer of Osseointegrated Prostheses Fixations

PubMed Central

Tomaszewski, P. K.; Verdonschot, N.; Bulstra, S. K.

2010-01-01

An alternative solution to conventional stump–socket prosthetic limb attachment is offered by direct skeletal fixation. This study aimed to assess two percutaneous trans-femoral implants, the OPRA system (Integrum AB, Göteborg, Sweden), and the ISP Endo/Exo prosthesis (ESKA Implants AG, Lübeck, Germany) on bone failure and stem–bone interface mechanics both early post-operative (before bony ingrowth) and after full bone ingrowth. Moreover, mechanical consequences of implantation of those implants in terms of changed loading pattern within the bone and potential consequences on long-term bone remodeling were studied using finite-element models that represent the intact femur and implants fitted in amputated femora. Two experimentally measured loads from the normal walking cycle were applied. The analyses revealed that implantation of percutaneous prostheses had considerable effects on stress and strain energy density levels in bone. This was not only caused by the implant itself, but also by changed loading conditions in the amputated leg. The ISP design promoted slightly more physiological strain energy distribution (favoring long-term bone maintenance), but the OPRA design generated lower bone stresses (reducing bone fracture risk). The safety factor against mechanical failure of the two percutaneous designs was relatively low, which could be improved by design optimization of the implants. PMID:20309731

Osteoporosis and bisphosphonate-related osteonecrosis in a dental school implant patient population.

PubMed

Al-Sabbagh, Mohanad; Robinson, Fonda G; Romanos, Georgios; Thomas, Mark V

2015-06-01

Studies have demonstrated an inconsistent association between implant failure and bone mineral density. The prevalence of osteoporosis in US adults has been reported to range from 5% to 10% in women and from 2% to 4% in men. The prevalence of bisphosphonate (BP)-related osteonecrosis of the jaw (BRONJ) has been reported to range from 0% to 4.3% of patients taking oral BPs. The purpose of this study was to calculate the risk of dental implant loss and the incidence of BRONJ in patients with osteoporosis at the University of Kentucky College of Dentistry (UKCD). This study analyzed data collected from patients who had implants placed between 2000 and 2004 at UKCD. Data were gathered from patient interviews regarding implant survival and patient-satisfaction parameters, and interviews were conducted either chairside at a scheduled maintenance appointment or by telephone interview. Among 203 patients who received 515 implants, the prevalence of osteoporosis was 23.3% for women and 1.2% for men. None of the 20 patients who reported a history of oral BP use exhibited BRONJ, and there were no implant failures in patients with a history of osteoporosis. In this study, osteoporosis conferred no risk of implant failure, and oral BP therapy was not associated with BRONJ.

Hypothesis: Co-transfer of genuine embryos and implantation-promoting compounds via artificial containers improve endometrium receptivity.

PubMed

Celik, Onder; Acet, Mustafa; Celik, Sudenaz; Sahin, Levent; Koc, Onder; Celik, Nilufer

2017-06-01

As with other organs endometrial functions are altered with the advancing age. Age related decrease in reproductive functions leads to decline in the number of oocytes retrieved and the synthesis of endometrial receptivity molecules. Despite the significant improvement in assisted reproductive technologies we do not have so many options to enhance endometrial receptivity. Due to lack of drugs having endometrium receptivity enhancement properties, oocyte donation seems to be the only solution for women with implantation failure. The euploid oocytes come from young and healthy donors may overcome age associated endometrial receptivity defect. Nevertheless, many reasons restrict us from using oocyte donation in women with implantation failure. We, therefore, hypothesized that by mimicking a young blastocyst's effect on endometrium, the transfer of genuine embryos and implantation-promoting compounds together might be the new treatment option for infertile women with recurrent implantation failure. Artificial beads, MI or GV oocytes, and empty zona can be used as a container for intrauterine replacement of implantation-promoting compounds. Copyright © 2017 Elsevier Ltd. All rights reserved.

Fluid status monitoring with a wireless network to reduce cardiovascular-related hospitalizations and mortality in heart failure: rationale and design of the OptiLink HF Study (Optimization of Heart Failure Management using OptiVol Fluid Status Monitoring and CareLink)

PubMed Central

Brachmann, Johannes; Böhm, Michael; Rybak, Karin; Klein, Gunnar; Butter, Christian; Klemm, Hanno; Schomburg, Rolf; Siebermair, Johannes; Israel, Carsten; Sinha, Anil-Martin; Drexler, Helmut

2011-01-01

Aims The Optimization of Heart Failure Management using OptiVol Fluid Status Monitoring and CareLink (OptiLink HF) study is designed to investigate whether OptiVol fluid status monitoring with an automatically generated wireless CareAlert notification via the CareLink Network can reduce all-cause death and cardiovascular hospitalizations in an HF population, compared with standard clinical assessment. Methods Patients with newly implanted or replacement cardioverter-defibrillator devices with or without cardiac resynchronization therapy, who have chronic HF in New York Heart Association class II or III and a left ventricular ejection fraction ≤35% will be eligible to participate. Following device implantation, patients are randomized to either OptiVol fluid status monitoring through CareAlert notification or regular care (OptiLink ‘on' vs. ‘off'). The primary endpoint is a composite of all-cause death or cardiovascular hospitalization. It is estimated that 1000 patients will be required to demonstrate superiority of the intervention group to reduce the primary outcome by 30% with 80% power. Conclusion The OptiLink HF study is designed to investigate whether early detection of congestion reduces mortality and cardiovascular hospitalization in patients with chronic HF. The study is expected to close recruitment in September 2012 and to report first results in May 2014. ClinicalTrials.gov Identifier: NCT00769457 PMID:21555324

The influence of repeated abutment changes on peri-implant tissue stability: 3-year post-loading results from a multicentre randomised controlled trial.

PubMed

Bressan, Eriberto; Grusovin, Maria Gabriella; D'Avenia, Ferdinando; Neumann, Konrad; Sbricoli, Luca; Luongo, Giuseppe; Esposito, Marco

To evaluate the influence of at least three abutment disconnections in conventional loaded implants against placement of a definitive abutment in immediately non-occlusal loaded implants on hard and soft tissue changes. A secondary aim was to evaluate whether the presence of less than 2 mm of keratinised mucosa is associated with increased peri-implant marginal bone loss and soft tissue recessions. Eighty patients requiring one single crown or one fixed partial prosthesis supported by a maximum of three implants were randomised, after implants were placed with more than 35 Ncm, according to a parallel group design to receive definitive abutments that were loaded immediately (definitive abutment or immediate loading group) or transmucosal abutments, which were delayed loaded after 3 months and removed at least three times: 1. At impression taking (3 months after implant placement); 2. When checking the zirconium core on titanium abutments at single crowns or the fitting the metal structure at prostheses supported by multiple implants; 3. At delivery of the definitive prostheses (repeated disconnection or conventional loading group). Patients were treated at four centres and each patient contributed to the study, with only one prosthesis followed for 3 years after initial loading. Outcome measures were: prosthesis failures, implant failures, complications, pink aesthetic score (PES), buccal recessions, patient satisfaction, peri-implant marginal bone level changes and height of the keratinised mucosa. Forty patients were randomly allocated to each group according to a parallel group design. Six patients from the definitive abutment group dropped out or died, and one left from the repeated disconnection group. One implant, from the repeated disconnection group, fractured (difference = 3%; CI 95%: -2%, 8%; P = 1). Four provisional crowns and one definitive single crown had to be remade because of poor fitting, and one definitive crown and one definitive prosthesis because of ceramic and implant fracture, respectively, in the repeated disconnection group vs one provisional prosthesis from the definitive abutment group due to frequent debondings (difference = 15%; CI 95%: 2%, 28%; P = 0.060). Five patients from the definitive abutment group and four patients from the repeated disconnection group were affected by complications (difference = 4%; CI 95%: -11%, 20%; P = 0.725). PES scores assessed at 3 years post-loading were 11.7 (standard deviation = 1.8) mm for the definitive abutment group and 11.3 (1.5) mm for the repeated abutment changes group (difference = 0.4; CI 95%: -0.4, 1.2; P = 0.315). However, there was a difference of 0.26 out of a maximum score of 2 in favour of the definitive abutment group for soft tissue contour only. Buccal recessions at 3 years post-loading amounted to -0.1 (0.8) mm for the definitive abutment group and -0.1 (1.2) mm for the repeated abutment changes group (it was actually a soft tissue gain; difference = 0.01 mm CI 95%: -0.48, 0.50; P = 0.965). All patients declared being very satisfied or satisfied with the function and aesthetics of the prostheses and said they would undergo the same procedure again, with the exception of one patient from the repeated disconnection group who was uncertain regarding function. Mean peri-implant marginal bone loss 3 years after loading was 0.07 (0.18) mm for the definitive abutment group and 0.50 (0.93) mm for the repeated abutment changes group (difference = 0.43 mm; CI 95%: 0.13, 0.74; P = 0.007). The height of keratinised mucosa at 3 years post-loading was 2.8 (1.3) mm for the definitive abutment group and 2.8 (1.6) mm for the repeated abutment changes group (difference = 0.03; CI 95%: -0.67, 0.73; P = .926). Up to 3 years after initial loading there were no statistically significant differences between the two procedures, with the exception of 0.4 mm more marginal bone loss at implants subjected to three abutment disconnections. There were no significantly increased marginal bone loss (difference = 0.1 mm, CI 95%: -0.3, 0.5, P = 0.590) or buccal recessions (difference = 0.1 mm, CI 95%: -0.4, 0.7, P = 0.674) at implants with less than 2 mm of keratinised mucosa at loading. Three-year post-loading data showed that repeated abutment disconnections significantly increased bone loss of 0.43 mm, but this difference may not be considered clinically relevant; therefore clinicians can use the procedure they find more convenient for each specific patient. Immediately non-occlusally loaded dental implants are a viable alternative to conventional loading and no increased bone loss or buccal recessions were noticed at implants with less than 2 mm of keratinised mucosa. Conflict of interest statement: This trial was partially funded by Dentsply Sirona Implants, the manufacturer of the implants and other products evaluated in this investigation. However, data belonged to the authors and by no means did the manufacturer interfere with the conduct of the trial or the publication of the results, with the exception of rejecting a proposal to change the protocol, after the trial was started, allowing the use of indexed abutments.

Fracture strength and probability of survival of narrow and extra-narrow dental implants after fatigue testing: In vitro and in silico analysis.

PubMed

Bordin, Dimorvan; Bergamo, Edmara T P; Fardin, Vinicius P; Coelho, Paulo G; Bonfante, Estevam A

2017-07-01

To assess the probability of survival (reliability) and failure modes of narrow implants with different diameters. For fatigue testing, 42 implants with the same macrogeometry and internal conical connection were divided, according to diameter, as follows: narrow (Ø3.3×10mm) and extra-narrow (Ø2.9×10mm) (21 per group). Identical abutments were torqued to the implants and standardized maxillary incisor crowns were cemented and subjected to step-stress accelerated life testing (SSALT) in water. The use-level probability Weibull curves, and reliability for a mission of 50,000 and 100,000 cycles at 50N, 100, 150 and 180N were calculated. For the finite element analysis (FEA), two virtual models, simulating the samples tested in fatigue, were constructed. Loading at 50N and 100N were applied 30° off-axis at the crown. The von-Mises stress was calculated for implant and abutment. The beta (β) values were: 0.67 for narrow and 1.32 for extra-narrow implants, indicating that failure rates did not increase with fatigue in the former, but more likely were associated with damage accumulation and wear-out failures in the latter. Both groups showed high reliability (up to 97.5%) at 50 and 100N. A decreased reliability was observed for both groups at 150 and 180N (ranging from 0 to 82.3%), but no significant difference was observed between groups. Failure predominantly involved abutment fracture for both groups. FEA at 50N-load, Ø3.3mm showed higher von-Mises stress for abutment (7.75%) and implant (2%) when compared to the Ø2.9mm. There was no significant difference between narrow and extra-narrow implants regarding probability of survival. The failure mode was similar for both groups, restricted to abutment fracture. Copyright © 2017 Elsevier Ltd. All rights reserved.

Meta-Review of the Quantity and Quality of Evidence for Knee Arthroplasty Devices.

PubMed

Gagliardi, Anna R; Ducey, Ariel; Lehoux, Pascale; Ross, Sue; Trbovich, Patricia; Easty, Anthony; Bell, Chaim; Takata, Julie; Pabinger, Christof; Urbach, David R

2016-01-01

Some cardiovascular devices are licensed based on limited evidence, potentially exposing patients to devices that are not safe or effective. Research is needed to ascertain if the same is true of other types of medical devices. Knee arthroplasty is a widely-used surgical procedure yet implant failures are not uncommon. The purpose of this study was to characterize available evidence on the safety and effectiveness of knee implants. A review of primary studies included in health technology assessments (HTA) on total (TKA) and unicompartmental knee arthroplasty (UKA) was conducted. MEDLINE, EMBASE, CINAHL, Cochrane Library and Biotechnology & BioEngineering Abstracts were searched from 2005 to 2014, plus journal tables of contents and 32 HTA web sites. Patients were aged 18 and older who underwent primary TKA or UKA assessed in cohort or randomized controlled studies. Summary statistics were used to report study characteristics. A total of 265 eligible primary studies published between 1986 and 2014 involving 59,217 patients were identified in 10 HTAs (2 low, 7 moderate, 1 high risk of bias). Most evaluated TKA (198, 74.5%). The quality of evidence in primary studies was limited. Most studies were industry-funded (23.8%) or offered no declaration of funding or conflict of interest (44.9%); based on uncontrolled single cohorts (58.5%), enrolled fewer than 100 patients (66.4%), and followed patients for 2 years or less (UKA: single cohort 29.8%, comparative cohort 16.7%, randomized trial 25.0%; TKA: single cohort 25.0%, comparative cohort 31.4%, randomized trial 48.6%). Furthermore, most devices were evaluated in only one study (55.3% TKA implants, 61.1% UKA implants). Patients, physicians, hospitals and payers rely on poor-quality evidence to support decisions about knee implants. Further research is needed to explore how decisions about the use of devices are currently made, and how the evidence base for device safety and effectiveness can be strengthened.

The effect of a single infusion of zoledronic acid on early implant migration in total hip arthroplasty. A randomized, double-blind, controlled trial.

PubMed

Friedl, Gerald; Radl, Roman; Stihsen, Christoph; Rehak, Peter; Aigner, Reingard; Windhager, Reinhard

2009-02-01

Aseptic loosening is the most frequent cause of implant failure in total hip arthroplasty. While a direct link between aseptic loosening and periprosthetic bone loss remains elusive, there is plentiful evidence for a close association with early implant migration. The present trial was primarily designed to evaluate whether a single infusion of 4 mg of zoledronic acid prevented early implant migration in patients with osteonecrosis of the femoral head. Fifty patients were consecutively enrolled to receive either zoledronic acid or saline solution after cementless total hip arthroplasty. Radiographs, biochemical parameters of bone turnover, and the Harris hip-rating score were determined preoperatively and at each follow-up examination at seven weeks, six months, one year, and yearly thereafter. The median follow-up period was 2.8 years. We found a significant subsidence of the stem of up to a mean (and standard deviation) of -1.2 +/- 0.6 mm at two years within the control group, and the cups had a mean medialization of 0.6 +/- 1.0 mm and a mean cranialization of 0.6 +/- 0.8 mm (p < 0.001). Treatment with zoledronic acid effectively minimized the migration of the cups in both the transverse and the vertical direction (mean, 0.15 +/- 0.6 mm and 0.06 +/- 0.6 mm, respectively; p < 0.05), while only a trend to decreased subsidence of the stem was detected. Finally, the Harris hip score rapidly increased over time in both treatment groups, although this increase was significantly more pronounced in the zoledronate-treated group than in the control group (analysis of variance, p = 0.008). A single infusion of zoledronic acid shows promise in improving initial fixation of a cementless implant, which may improve the clinical outcome of total hip arthroplasty in patients with osteonecrosis of the femoral head.

PEEK with Reinforced Materials and Modifications for Dental Implant Applications

PubMed Central

Rahmitasari, Fitria; Ishida, Yuichi; Kurahashi, Kosuke; Matsuda, Takashi; Watanabe, Megumi

2017-01-01

Polyetheretherketone (PEEK) is a semi-crystalline linear polycyclic thermoplastic that has been proposed as a substitute for metals in biomaterials. PEEK can also be applied to dental implant materials as a superstructure, implant abutment, or implant body. This article summarizes the current research on PEEK applications in dental implants, especially for the improvement of PEEK surface and body modifications. Although various benchmark reports on the reinforcement and surface modifications of PEEK are available, few clinical trials using PEEK for dental implant bodies have been published. Controlled clinical trials, especially for the use of PEEK in implant abutment and implant bodies, are necessary. PMID:29563441

PEEK with Reinforced Materials and Modifications for Dental Implant Applications.

PubMed

Rahmitasari, Fitria; Ishida, Yuichi; Kurahashi, Kosuke; Matsuda, Takashi; Watanabe, Megumi; Ichikawa, Tetsuo

2017-12-15

Polyetheretherketone (PEEK) is a semi-crystalline linear polycyclic thermoplastic that has been proposed as a substitute for metals in biomaterials. PEEK can also be applied to dental implant materials as a superstructure, implant abutment, or implant body. This article summarizes the current research on PEEK applications in dental implants, especially for the improvement of PEEK surface and body modifications. Although various benchmark reports on the reinforcement and surface modifications of PEEK are available, few clinical trials using PEEK for dental implant bodies have been published. Controlled clinical trials, especially for the use of PEEK in implant abutment and implant bodies, are necessary.

Biodegradable Magnesium (Mg) Implantation Does Not Impose Related Metabolic Disorders in Rats with Chronic Renal Failure

PubMed Central

Wang, Jiali; Xu, Jiankun; Liu, Waiching; Li, Yangde; Qin, Ling

2016-01-01

Mg and its alloys have been considered as one of the most promising biodegradable medical devices, but it was still unclear whether hypermagnesemia involved health risks would occur in persons with kidney disease due to their deteriorated kidney function for Mg ions excretion from their body. In this study, we established a chronic renal failure (CRF) model in rats induced by adenine administration prior to Mg implantation, aiming to predict if CRF patients are suitable for the use of Mg implants. The results showed that Mg levels in serum, urine, feces and internal organs had no significant changes after Mg implantation for both normal and CRF rats. Biochemical indices detection and histopathological analysis in kidney, liver and heart tissue confirmed that Mg implants did not induce any extra damage in animals even with renal failure. Our study indicates that Mg based orthopaedic medical device may be considered for use in CRF patients without biosafety concerns. PMID:27210744

Biodegradable Magnesium (Mg) Implantation Does Not Impose Related Metabolic Disorders in Rats with Chronic Renal Failure

NASA Astrophysics Data System (ADS)

Wang, Jiali; Xu, Jiankun; Liu, Waiching; Li, Yangde; Qin, Ling

2016-05-01

Mg and its alloys have been considered as one of the most promising biodegradable medical devices, but it was still unclear whether hypermagnesemia involved health risks would occur in persons with kidney disease due to their deteriorated kidney function for Mg ions excretion from their body. In this study, we established a chronic renal failure (CRF) model in rats induced by adenine administration prior to Mg implantation, aiming to predict if CRF patients are suitable for the use of Mg implants. The results showed that Mg levels in serum, urine, feces and internal organs had no significant changes after Mg implantation for both normal and CRF rats. Biochemical indices detection and histopathological analysis in kidney, liver and heart tissue confirmed that Mg implants did not induce any extra damage in animals even with renal failure. Our study indicates that Mg based orthopaedic medical device may be considered for use in CRF patients without biosafety concerns.

Improvement of renal function after human umbilical cord mesenchymal stem cell treatment on chronic renal failure and thoracic spinal cord entrapment: a case report.

PubMed

Rahyussalim, Ahmad Jabir; Saleh, Ifran; Kurniawati, Tri; Lutfi, Andi Praja Wira Yudha

2017-11-30

Chronic renal failure is an important clinical problem with significant socioeconomic impact worldwide. Thoracic spinal cord entrapment induced by a metabolic yield deposit in patients with renal failure results in intrusion of nervous tissue and consequently loss of motor and sensory function. Human umbilical cord mesenchymal stem cells are immune naïve and they are able to differentiate into other phenotypes, including the neural lineage. Over the past decade, advances in the field of regenerative medicine allowed development of cell therapies suitable for kidney repair. Mesenchymal stem cell studies in animal models of chronic renal failure have uncovered a unique potential of these cells for improving function and regenerating the damaged kidney. We report a case of a 62-year-old ethnic Indonesian woman previously diagnosed as having thoracic spinal cord entrapment with paraplegic condition and chronic renal failure on hemodialysis. She had diabetes mellitus that affected her kidneys and had chronic renal failure for 2 years, with creatinine level of 11 mg/dl, and no urinating since then. She was treated with human umbilical cord mesenchymal stem cell implantation protocol. This protocol consists of implantation of 16 million human umbilical cord mesenchymal stem cells intrathecally and 16 million human umbilical cord mesenchymal stem cells intravenously. Three weeks after first intrathecal and intravenous implantation she could move her toes and her kidney improved. Her creatinine level decreased to 9 mg/dl. Now after 8 months she can raise her legs and her creatinine level is 2 mg/dl with normal urinating. Human umbilical cord mesenchymal stem cell implantations led to significant improvement for spinal cord entrapment and kidney failure. The major histocompatibility in allogeneic implantation is an important issue to be addressed in the future.

Generator exchange is associated with an increased rate of Sprint Fidelis lead failure.

PubMed

Lovelock, Joshua D; Patel, Ayesha; Mengistu, Andenet; Hoskins, Michael; El-Chami, Mikhael; Lloyd, Michael S; Leon, Angel; DeLurgio, David; Langberg, Jonathan J

2012-10-01

The Medtronic Sprint Fidelis defibrillator lead is at an increased risk for failure and was recalled in October 2007. Approximately 268,000 leads were implanted, and more than 100,000 patients still have active Fidelis leads. A number of studies have examined the rate and clinical predictors of lead failure, but none has addressed the effect of an implantable cardioverter-defibrillator generator exchange on subsequent lead failure. Although the manufacturer asserts that "Sprint Fidelis performance after device change-out is similar to lead performance without device change-out," published data are lacking. To assess the effect of implantable cardioverter-defibrillator generator exchange on the rate of Fidelis lead failure. A chart review was conducted in patients who underwent implantation of a Fidelis lead. Patients with a functioning Fidelis lead at generator exchange were compared with controls with leads implanted for a comparable amount of time not undergoing ICD replacement. A total of 1366 patients received a Fidelis lead prior to the recall, of which 479 were still actively followed. Seventy-two patients with a functioning lead underwent generator exchange without lead replacement. Following generator replacement, 15 leads failed. Sixty percent of the Fidelis leads failed within 3 months. Generator exchange increased the rate of lead failure compared with matched controls (20.8% vs 2.54%; P < .001). Generator exchange is associated with a higher than expected rate of Fidelis lead failure, often within 3 months. The risk-benefit ratio of Fidelis lead replacement at the time of generator exchange may be greater than appreciated. Copyright © 2012 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

[The Development and Application of the Orthopaedics Implants Failure Database Software Based on WEB].

PubMed

Huang, Jiahua; Zhou, Hai; Zhang, Binbin; Ding, Biao

2015-09-01

This article develops a new failure database software for orthopaedics implants based on WEB. The software is based on B/S mode, ASP dynamic web technology is used as its main development language to achieve data interactivity, Microsoft Access is used to create a database, these mature technologies make the software extend function or upgrade easily. In this article, the design and development idea of the software, the software working process and functions as well as relative technical features are presented. With this software, we can store many different types of the fault events of orthopaedics implants, the failure data can be statistically analyzed, and in the macroscopic view, it can be used to evaluate the reliability of orthopaedics implants and operations, it also can ultimately guide the doctors to improve the clinical treatment level.

Dental implants in patients with ectodermal dysplasia: A systematic review.

PubMed

Chrcanovic, Bruno Ramos

2018-05-21

This study sought to assess the clinical outcome and survival rate of oral implants placed in individuals with ectodermal dysplasia (ED), based on previously published studies. An electronic search without time restrictions was undertaken in 5 databases (PubMed/Medline, Web of Science, ScienceDirect, J-Stage, Lilacs). Descriptive statistics, Kaplan Meier estimator and implant failure probability were calculated. 90 publications were included, reporting 228 ED patients that received 1472 implants (1392 conventional, 47 zygomatic, 33 mini-implants). Mean age of the patients was 20.2 ± 6.8 years (2-56). Patients had a mean of 3.2 ± 2.5 maxillary and 2.1 ± 2.6 mandibular permanent teeth (min-max, 0-14). Patients received a mean of 8.2 ± 3.8 implants (1-20). Most implants were placed in the third decade of life, 24.6% of the implants were placed in children (0-17 years of age). 1391 implants had information on follow-up (72 failures, 5.2%). The 20-year CSR was 84.6%. The probability of failure was 4.5% (95%CI 3.5%-5.6%, p < 0.001). Additional treatments performed were Le Fort I (99 implants, 20 patients, 3.5% failed), grafting (497 implants, 77 patients, 5.2% failed), distraction osteogenesis (79 implants, 16 patients, 10.1% failed). Mean follow-up was 42.9 ± 41.9 months (min-max, 2-240). Dental implants placed in ED patients, either infants or adults, present a high survival rate (20-year CSR 84.6%). Copyright © 2018 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

In Vitro Investigation of the Effect of Oral Bacteria in the Surface Oxidation of Dental Implants.

PubMed

Sridhar, Sathyanarayanan; Wilson, Thomas G; Palmer, Kelli L; Valderrama, Pilar; Mathew, Mathew T; Prasad, Shalini; Jacobs, Michael; Gindri, Izabelle M; Rodrigues, Danieli C

2015-10-01

Bacteria are major contributors to the rising number of dental implant failures. Inflammation secondary to bacterial colonization and bacterial biofilm is a major etiological factor associated with early and late implant failure (peri-implantitis). Even though there is a strong association between bacteria and bacterial biofilm and failure of dental implants, their effect on the surface of implants is yet not clear. To develop and establish an in vitro testing methodology to investigate the effect of early planktonic bacterial colonization on the surface of dental implants for a period of 60 days. Commercial dental implants were immersed in bacterial (Streptococcus mutans in brain-heart infusion broth) and control (broth only) media. Immersion testing was performed for a period of 60 days. During testing, optical density and pH of immersion media were monitored. The implant surface was surveyed with different microscopy techniques post-immersion. Metal ion release in solution was detected with an electrochemical impedance spectroscopy sensor platform called metal ion electrochemical biosensor (MIEB). Bacteria grew in the implant-containing medium and provided a sustained acidic environment. Implants immersed in bacterial culture displayed various corrosion features, including surface discoloration, deformation of rough and smooth interfaces, pitting attack, and severe surface rusting. The surface features were confirmed by microscopic techniques, and metal particle generation was detected by the MIEB. Implant surface oxidation occurred in bacteria-containing medium even at early stages of immersion (2 days). The incremental corrosion resulted in dissolution of metal ions and debris into the testing solution. Dissolution of metal ions and particles in the oral environment can trigger or contribute to the development of peri-implantitis at later stages. © 2015 Wiley Periodicals, Inc.

The implant infection paradox: why do some succeed when others fail? Opinion and discussion paper.

PubMed

Yue, C; Zhao, B; Ren, Y; Kuijer, R; van der Mei, H C; Busscher, H J; Rochford, E T J

2015-06-05

Biomaterial-implants are frequently used to restore function and form of human anatomy. However, the presence of implanted biomaterials dramatically elevates infection risk. Paradoxically, dental-implants placed in a bacteria-laden milieu experience moderate failure-rates, due to infection (0.0-1.1%), similar to the ones of joint-arthroplasties placed in a near-sterile environment (0.1-1.3%). Transcutaneous bone-fixation pins breach the immune-barrier of the epidermis, exposing underlying sterile-tissue to an unsterile external environment. In contrast to dental-implants, also placed in a highly unsterile environment, these pins give rise to relatively high infection-associated failure-rates of up to 23.0%. Herein, we attempt to identify causes as to why dental-implants so often succeed, where others fail. The major part of all implants considered are metal-made, with similar surface-finishes. Material choice was therefore discarded as underlying the paradox. Antimicrobial activity of saliva has also been suggested as a cause for the success of dental-implants, but was discarded because saliva is the implant-site-fluid from which viable bacteria adhere. Crevicular fluid was discarded as it is largely analogous to serum. Instead, we attribute the relative success of dental-implants to (1) ability of oral tissues to heal rapidly in the continuous presence of commensal bacteria and opportunistic pathogens, and (2) tolerance of the oral immune-system. Inability of local tissue to adhere, spread and grow in presence of bacteria and an intolerant immune-system are identified as the likely main causes explaining the susceptibility of other implants to infection-associated failure. In conclusion, it is the authors' belief that new anti-infection strategies for a wide range of biomaterial-implants may be derived from the relative success of dental-implants.

Immediate versus delayed loading of strategic mini dental implants for the stabilization of partial removable dental prostheses: a patient cluster randomized, parallel-group 3-year trial.

PubMed

Mundt, Torsten; Al Jaghsi, Ahmad; Schwahn, Bernd; Hilgert, Janina; Lucas, Christian; Biffar, Reiner; Schwahn, Christian; Heinemann, Friedhelm

2016-07-30

Acceptable short-term survival rates (>90 %) of mini-implants (diameter < 3.0 mm) are only documented for mandibular overdentures. Sound data for mini-implants as strategic abutments for a better retention of partial removable dental prosthesis (PRDP) are not available. The purpose of this study is to test the hypothesis that immediately loaded mini-implants show more bone loss and less success than strategic mini-implants with delayed loading. In this four-center (one university hospital, three dental practices in Germany), parallel-group, controlled clinical trial, which is cluster randomized on patient level, a total of 80 partially edentulous patients with unfavourable number and distribution of remaining abutment teeth in at least one jaw will receive supplementary min-implants to stabilize their PRDP. The mini-implant are either immediately loaded after implant placement (test group) or delayed after four months (control group). Follow-up of the patients will be performed for 36 months. The primary outcome is the radiographic bone level changes at implants. The secondary outcome is the implant success as a composite variable. Tertiary outcomes include clinical, subjective (quality of life, satisfaction, chewing ability) and dental or technical complications. Strategic implants under an existing PRDP are only documented for standard-diameter implants. Mini-implants could be a minimal invasive and low cost solution for this treatment modality. The trial is registered at Deutsches Register Klinischer Studien (German register of clinical trials) under DRKS-ID: DRKS00007589 ( www.germanctr.de ) on January 13(th), 2015.

Emotional wellbeing of blind patients in a pilot trial with subretinal implants.

PubMed

Peters, Tobias; Klingberg, Stefan; Zrenner, Eberhart; Wilhelm, Barbara

2013-06-01

Participation in first human applications of retinal neuroprosthesis may create psychological stress for blind retinitis pigmentosa patients. The aim of this study was to assess the emotional wellbeing of patients undergoing implantation of a subretinal implant. Nine blind patients participating in a pilot trial with subretinal implants were enlisted. The Brief Symptom Inventory (BSI), a short self-report scale of nine primary symptoms, was used to assess reaction to the psychological distress related to study participation. The number and the intensity of symptoms were analysed, and global scores for overall psychological distress (tGSI), severity of reported symptoms (tPDSI), and level number of self-reported symptoms (tPST) were calculated. The questionnaire was administered before implantation, 2-3 times during the trial and before explantation. There were no significant alterations during the trial for the average scores of the nine primary symptoms. One patient, however, showed values higher than the norm, for six subscores before implantation and for eight subscores before explantation. A significant improvement was found in both the overall psychological distress level (tGSI) and the severity of reported symptoms (tPDSI) at the final visit, compared to those at the study start. The number of self-reported symptoms (tPST) was not significantly altered. In the first ongoing pilot trial with an active, cable-bound subretinal implant, we found that trial participation and the implant procedure and subsequent testing did not have any adverse effects on the participants' emotional wellbeing. Their distress generally improved during study participation, rather than showing signs of decreased wellbeing.

Mandibular single-implant overdentures: a review with surgical and prosthodontic perspectives of a novel approach.

PubMed

Alsabeeha, Nabeel; Payne, Alan G T; De Silva, Rohana K; Swain, Michael V

2009-04-01

To review the literature on mandibular single-implant overdentures (opposing complete maxillary dentures), and present surgical and prosthodontic perspectives of a novel approach for this treatment option. An electronic search through the databases of Pubmed, Embase and Medline using the linked key words 'mandibular single implant overdentures' was performed. The search was limited to English language articles published up to August 2008. Hand searches through articles retrieved from the electronic search, peer-reviewed journals and recent conference proceedings were also conducted. A limited number of reports were identified on mandibular single-implant overdentures (opposing maxillary complete dentures). They comprised of case-series reports, short-term prospective trials and current randomized-controlled clinical trials. Different loading protocols with different implant systems have been used, but always with regular diameter implants. Specific anatomical and vascular dangers of the mandibular midline symphysis are identified including a novel surgical approach using a currently available short, wide diameter tapered implant. In addition, the prosthodontic rationale for using a larger attachment system (incorporating a platform switch) for mandibular single-implant overdentures is described. The review reveals that there is a lack of published randomized clinical trials using mandibular single-implant overdentures, opposing maxillary complete dentures. Without the evidence from randomized clinical trials, routine use of this novel approach cannot be recommended, compared with using regular diameter implants and matching attachment systems.

DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity (DUTCH PEERS): rationale and study design of a randomized multicenter trial in a Dutch all-comers population.

PubMed

Tandjung, Kenneth; Basalus, Mounir W Z; Sen, Hanim; Jessurun, Gillian A J; Danse, Peter W; Stoel, Martin; Linssen, Gerard C M; Derks, Anita; van Loenhout, Ton T; Nienhuis, Mark B; Hautvast, Raymond W M; von Birgelen, Clemens

2012-04-01

Drug-eluting stents (DES) are increasingly used for the treatment of coronary artery disease. An optimized DES performance is desirable to successfully treat various challenging coronary lesions in a broad population of patients. In response to this demand, third-generation DES with an improved deliverability were developed. Promus Element (Boston Scientific, Natick, MA) and Resolute Integrity (Medtronic Vascular, Santa Rosa, CA) are 2 novel third-generation DES for which limited clinical data are available. Accordingly, we designed the current multicenter study to investigate in an all-comers population whether the clinical outcome is similar after stenting with Promus Element versus Resolute Integrity. DUTCH PEERS is a multicenter, prospective, single-blinded, randomized trial in a Dutch all-comers population. Patients with all clinical syndromes who require percutaneous coronary interventions with DES implantation are eligible. In these patients, the type of DES implanted will be randomized in a 1:1 ratio between Resolute Integrity versus Promus Element. The trial is powered based on a noninferiority hypothesis. For each stent arm, 894 patients will be enrolled, resulting in a total study population of 1,788 patients. The primary end point is the incidence of target vessel failure at 1-year follow-up. DUTCH PEERS is the first randomized multicenter trial with a head-to-head comparison of Promus Element and Resolute Integrity to investigate the safety and efficacy of these third-generation DES. Copyright © 2012 Mosby, Inc. All rights reserved.

How does a clinical trial fit into the real world? The RELAX-AHF study population into the EAHFE registry.

PubMed

Miró, Òscar; Gil, Víctor; Müller, Christian; Mebazaa, Alexander; Bueno, Héctor; Martín-Sánchez, Francisco Javier; Herrero, Pablo; Jacob, Javier; Llorens, Pere

2015-10-01

To test how accurate the recently published RELAX-AHF trial was in recruiting real-world patients with acute-decompensated heart failure (ADHF). We compared clinical and outcome data of patients receiving serelaxin in the RELAX-AHF trial (RELAX group, n = 581) with patients included in the EAHFE registry [5497 ADHF from 29 Spanish emergency departments (EDs)]. The EAHFE registry was split into two groups: EAHFE-non-RELAX (patients not fulfilling the RELAX-AHF inclusion criteria; n = 3205, 58.3 %) and EAHFE-RELAX A (patients fulfilling RELAX-AHF inclusion criteria; n = 2292, 41.7 %). The latter group was further refined by also applying exclusion criteria (EAHFE-RELAX B; n = 964, 17.4 %). Both EAHFE-RELAX groups differed from the EAHFE-non-RELAX group in multiple aspects, with the lower the proportion of patients with implantable cardiac defibrillator and with pulmonary diseases the greater the differences found. The RELAX group, compared with the EAHFE-RELAX groups, significantly included fewer females, younger patients, less in NYHA class I/II, less with implantable cardiac defibrillator and on beta-blocker treatment, and patients had lower systolic blood pressure and cardiac and respiratory rates at ED arrival. The EAHFE-RELAX groups had a significantly lower all-cause mortality than EAHFE-non-RELAX group, and qualitative analysis suggested that EAHFE-RELAX groups had a higher mortality than the RELAX group. Patients included in the RELAX-AHF trial showed unanticipated differences when compared with a population from the EAHFE registry fulfilling very similar inclusion and exclusion criteria.

Comparison of the compressive strength of 3 different implant design systems.

PubMed

Pedroza, Jose E; Torrealba, Ysidora; Elias, Augusto; Psoter, Walter

2007-01-01

The aims of this study were twofold: to compare the static compressive strength at the implant-abutment interface of 3 design systems and to describe the implant abutment connection failure mode. A stainless steel holding device was designed to align the implants at 30 degrees with respect to the y-axis. Sixty-nine specimens were used, 23 for each system. A computer-controlled universal testing machine (MTS 810) applied static compression loading by a unidirectional vertical piston until failure. Specimens were evaluated macroscopically for longitudinal displacement, abutment looseness, and screw and implant fracture. Data were analyzed by analysis of variance (ANOVA). The mean compressive strength for the Unipost system was 392.5 psi (SD +/-40.9), for the Spline system 342.8 psi (SD+/-25.8), and for the Screw-Vent system 269.1 psi (SD+/-30.7). The Unipost implant-abutment connection demonstrated a statistically significant superior mechanical stability (P < or = .009) compared with the Spline implant system. The Spline implant system showed a statistically significant higher compressive strength than the Screw-Vent implant system (P < or =.009). Regarding failure mode, the Unipost system consistently broke at the same site, while the other systems failed at different points of the connection. The Unipost system demonstrated excellent fracture resistance to compressive forces; this resistance may be attributed primarily to the diameter of the abutment screw and the 2.5 mm counter bore, representing the same and a unique piece of the implant. The Unipost implant system demonstrated a statistically significant superior compressive strength value compared with the Spline and Screw-Vent systems, at a 30 degrees angulation.

Botulinum Toxin Type A as Preoperative Treatment for Immediately Loaded Dental Implants Placed in Fresh Extraction Sockets for Full-Arch Restoration of Patients With Bruxism.

PubMed

Mijiritsky, Eitan; Mortellaro, Carmen; Rudberg, Omri; Fahn, Miri; Basegmez, Cansu; Levin, Liran

2016-05-01

The aim of the present report was to describe the use of Botulinum toxin type A as preoperative treatment for immediately loaded dental implants placed in fresh extraction sockets for full-arch restoration of patients with bruxism. Patients with bruxism who were scheduled to receive immediately loaded full-arch implant supported fixed restorations were included in this retrospective clinical report. To reduce the occlusal forces applied in patients with bruxism, Botulinum toxin type A was introduced prior to the implant placement procedure. Patients were followed and implant survival as well as peri-implant bone level was assessed in each periodic follow-up visit. Adverse effects were also recorded. A control group with no use of Botulinum toxin was evaluated as well. A total of 26 patients (13 test and 13 control), with bruxism, aged 59.15 ± 11.43 years on average were included in this retrospective report and received immediately loaded dental implants placed in fresh extraction sockets for full-arch restoration. The test group treatment preceded by Botulinum toxin type A injection. Maxillary arches were supported by 8 to 10 implants while the mandibular arch was supported by 6 implants. All surgeries went uneventfully and no adverse effects were observed. The average follow-up time was 32.5 ± 10.4 months (range, 18-51). In the test group, no implant failures were recorded. One patient presented with 1 to 2 mm bone loss around 4 of the implants; the other implants presented with stable bone level. In the control group 1 patient lost 2 implants and another demonstrated 2 mm bone loss around 3 of the implants. The preoperative use of Botulinum toxin in patients with bruxism undergoing full-arch rehabilitation using immediately loaded dental implants placed in fresh extraction sockets seems to be a technique that deserves attention. Further long-term, large-scale randomized clinical trials will help to determine the additional benefit of this suggested treatment modality.

Experimental and failure analysis of the prosthetic finger joint implants

NASA Astrophysics Data System (ADS)

Naidu, Sanjiv H.

Small joint replacement arthroplasty of the hand is a well accepted surgical procedure to restore function and cosmesis in an individual with a crippled hand. Silicone elastomers have been used as prosthetic material in various small hand joints for well over three decades. Although the clinical science aspects of silicone elastomer failure are well known, the physical science aspects of prosthetic failure are scant and vague. In the following thesis, using both an animal model, and actual retrieved specimens which have failed in human service, experimental and failure analysis of silicone finger joints are presented. Fractured surfaces of retrieved silicone trapezial implants, and silicone finger joint implants were studied with both FESEM and SEM; the mode of failure for silicone trapezium is by wear polishing, whereas the finger joint implants failed either by fatigue fracture or tearing of the elastomer, or a combination of both. Thermal analysis revealed that the retrieved elastomer implants maintained its viscoelastic properties throughout the service period. In order to provide for a more functional and physiologic arthroplasty a novel finger joint (Rolamite prosthesis) is proposed using more recently developed thermoplastic polymers. The following thesis also addresses the outcome of the experimental studies of the Rolamite prosthesis in a rabbit animal model, in addition to the failure analysis of the thermoplastic polymers while in service in an in vivo synovial environment. Results of retrieved Rolamite specimens suggest that the use for thermoplastic elastomers such as block copolymer based elastomers in a synovial environment such as a mammalian joint may very well be limited.

Survival of dental implants in patients with Down syndrome: A case series.

PubMed

Limeres Posse, Jacobo; López Jiménez, Julian; Ruiz Villandiego, José C; Cutando Soriano, Antonio; Fernández Feijoo, Javier; Linazasoro Elorza, Maialen; Diniz Freitas, Márcio; Diz Dios, Pedro

2016-12-01

The need for tooth replacement in individuals with Down syndrome (DS) is explained by the high prevalence of dental agenesis and by the premature loss of teeth through severe periodontal disease. Dental implants may be the dental procedure of choice in some of these patients. The purpose of this clinical study was to analyze dental implant survival in a series of patients with DS. This was a multicenter, retrospective, observational study. Information on patients was gathered using a standardized questionnaire designed specifically for this study, including personal details, oral health status, information on the surgical and prosthetic phases, and follow-up visits. The questionnaire was sent to centers registered with the research network of the Spanish Society of Special Needs Dentistry (SEOENE). Patients with DS aged 18 years or older were included in the study if they had at least 1 dental implant and the corresponding prosthesis and had been followed up for at least a year. The study population was formed of 25 adult patients (13 men and 12 women) aged between 19 and 60 years. The interventions were performed by 5 different dental surgeons, usually under general anesthesia or deep sedation (n=17 patients). A total of 73 implants were inserted, 30 in the maxilla and 43 in the mandible, most commonly in the anterior region (n=51). The mean time to loading the implants was 4.1 ±1.3 months after surgery (range, 1 to 7 months). All patients completed prosthetic rehabilitation; the most frequent design used was the single fixed prosthesis (n=13 patients). A total of 17 (23.2%) implants failed in 8 (32%) patients; the majority (n=14 implants) failed in the postsurgical period before implant loading. The distribution by patients was 1 implant failure in 6 patients, 3 failures in 1 patient, and 8 failures in 1 patient. Dental implant survival is lower in individuals with DS than in the general population. The reasons for early implant failure in these patients have still not been clearly identified. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

The effects of simulated bone loss on the implant-abutment assembly and likelihood of fracture: an in vitro study.

PubMed

Manzoor, Behzad; Suleiman, Mahmood; Palmer, Richard M

2013-01-01

The crestal bone level around a dental implant may influence its strength characteristics by offering protection against mechanical failures. Therefore, the present study investigated the effect of simulated bone loss on modes, loads, and cycles to failure in an in vitro model. Different amounts of bone loss were simulated: 0, 1.5, 3.0, and 4.5 mm from the implant head. Forty narrow-diameter (3.0-mm) implant-abutment assemblies were tested using compressive bending and cyclic fatigue testing. Weibull and accelerated life testing analysis were used to assess reliability and functional life. Statistical analyses were performed using the Fisher-Exact test and the Spearman ranked correlation. Compressive bending tests showed that the level of bone loss influenced the load-bearing capacity of implant-abutment assemblies. Fatigue testing showed that the modes, loads, and cycles to failure had a statistically significant relationship with the level of bone loss. All 16 samples with bone loss of 3.0 mm or more experienced horizontal implant body fractures. In contrast, 14 of 16 samples with 0 and 1.5 mm of bone loss showed abutment and screw fractures. Weibull and accelerated life testing analysis indicated a two-group distribution: the 0- and 1.5-mm bone loss samples had better functional life and reliability than the 3.0- and 4.5-mm samples. Progressive bone loss had a significant effect on modes, loads, and cycles to failure. In addition, bone loss influenced the functional life and reliability of the implant-abutment assemblies. Maintaining crestal bone levels is important in ensuring biomechanical sustainability and predictable long-term function of dental implant assemblies.

Reduced Anxiety and Depression in Patients With Advanced Heart Failure After Left Ventricular Assist Device Implantation.

PubMed

Yost, Gardner; Bhat, Geetha; Mahoney, Edward; Tatooles, Antone

Despite the high prevalence of depression and anxiety in patients with advanced heart failure, the effects of left ventricular assist device (LVAD) implantation on these critically important aspects of mental health are not well understood. We sought to assess changes in depression and anxiety following LVAD implantation. The Beck Depression Inventory-II (BDI-II) and Beck Anxiety Inventory (BAI) were administered to 54 patients by a clinical psychologist at a mean of 12 days before LVAD implantation and 251 days after implantation. Patient demographics and clinical data were collected concurrently to psychologic testing. Changes in BDI-II, BAI, and clinical markers of heart failure were assessed using paired t-tests. A p < 0.05 was considered significant. The average age of the group was 56.63 years with a mean ejection fraction 20.8%. Before implantation, mean BAI and BDI scores indicated mild depression and anxiety. Following LVAD implantation, average scores for both BDI-II and BAI decreased significantly, indicating minimal depression and anxiety (12.6-8.54, p = 0.001 and 12.06-6.6, p < 0.001, respectively). Mean scores were significantly lowered in 11 and 8 of the 21 subdomains tested by the BAI and BDI, respectively. Significant improvements were noted in post-LVAD B-type natriuretic peptide, serum sodium, and blood urea nitrogen. Depression and anxiety scores improved significantly after LVAD implantation. Factors contributing to changes in depression and anxiety after LVAD could be related to the improvement in acute heart failure symptoms, functional capacity, and quality of life. Prospective studies with larger sample sizes are warranted. Copyright © 2017 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.

Mechanics and complications of reverse shoulder arthroplasty: morse taper failure analysis and prospective rectification

NASA Astrophysics Data System (ADS)

Hoskin, HLD; Furie, E.; Collins, W.; Ganey, TM; Schlatterer, DR

2017-05-01

Since Sir John Charnley began his monumental hip arthroplasty work in 1958, clinical researchers have been incrementally improving longevity and functionality of total joint systems, although implant failure occurs on occasion. The purpose of this study is to report the fracture of the humeral tray Morse taper of a reverse total shoulder system (RTSS), which to date has not been reported with metallurgic analysis for any RTSS. There was no reported antecedent fall, motor vehicle collision, or other traumatic event prior to implant fracture in this case. Analysis was performed on the retrieved failed implant by Scanning Electron Microscopy (SEM) and Electron Dispersion Spectroscopy (EDS) in an attempt to determine the failure method, as well as to offer improvements for future implants. At the time of revision surgery all explants were retained from the left shoulder of a 61-year old male who underwent a non-complicated RTSS 4 years prior. The explants, particularly the cracked humeral tray, were processed as required for SEM and EDS. Analysis was performed on the failure sites in order to determine the chemical composition of the different parts of the implant, discover the chemical composition of the filler metal used during the electron beam welding process, and to detect any foreign elements that could suggest corrosion or other evidence of failure etiology. Gross visual inspection of all explants revealed that implant failure was a result of dissociation of the taper from the humeral tray at the weld, leaving the Morse taper embedded in the humeral stem while the tray floated freely in the patient’s shoulder. SEM further confirmed the jagged edges noted grossly at the weld fracture site, both suggesting failure due to torsional forces. EDS detected elevated levels of carbon and oxygen at the fracture site on the taper only and not on the humeral tray. In order to determine the origin of the high levels of C and O, it was considered that in titanium alloys, C and O are used as stabilizers that help raise the temperature at which titanium can be cast. Since the presence of stabilizers reduces ductility and fatigue strength, all interstitial elements are removed after casting. Considering this, the presence of C and O suggests that not all of the interstitials were removed during the manufacturing process, resulting in decreased fatigue strength. Further destructive analytical testing would verify weld quality and failure mode. RTSSs are quite successful in select patients not amenable to traditional shoulder arthroplasty options. This case report highlights how an implant may function well for several years and then suddenly fail without warning. SEM and EDS analysis suggest that residual C and O in the taper lowered the metal implant’s integrity, leading to torsional cracking at the weld junction of the humeral tray and the taper. The elevated levels of C and O measured at fracture sites on both the tray and the taper suggest poor quality filler metal or failure to remove all interstitial elements after casting. In both cases, the results would be decreased fatigue strength and overall toughness, leading to mechanical failure. A manufacturer’s recall of all implants soon followed the reporting of this implant failure; subsequently, the metal materials were changed from Ti6Al4V to both titanium alloy and cobalt-chrome alloy (Co-Cr-Mo). Time will tell if the alterations were sufficient.

Viability of dental implants in head and neck irradiated patients: A systematic review.

PubMed

Zen Filho, Edson Virgílio; Tolentino, Elen de Souza; Santos, Paulo Sérgio Silva

2016-04-01

The purpose of this systematic review was to evaluate the safety of dental implants placed in irradiated bone and to discuss their viability when placed post-radiotherapy (RT). A systematic review was performed to answer the questions: "Are dental implants in irradiated bone viable?" and "What are the main factors that influence the loss of implants in irradiated patients?" The search strategy resulted in 8 publications. A total of 331 patients received 1237 implants, with an overall failure rate of 9.53%. The osseointegration success rates ranged between 62.5% and 100%. The optimal time interval between irradiation and dental implantation varied from 6 to 15 months. The interval time between RT and implant placement and the radiation doses are not associated with significant implant failure rates. The placement of implants in irradiated bone is viable, and head and neck RT should not be considered as a contraindication for dental rehabilitation with implants. © 2015 Wiley Periodicals, Inc. Head Neck 38: E2229-E2240, 2016. © 2015 Wiley Periodicals, Inc.

Spinal cord stimulation for cancer-related pain in adults.

PubMed

Peng, Lihua; Min, Su; Zejun, Zhou; Wei, Ke; Bennett, Michael I

2015-06-29

This is an update of a review first published in The Cochrane Library in Issue 3, 2013. Cancer-related pain places a heavy burden on public health with related high expenditure. Severe pain is associated with a decreased quality of life in patients with cancer. A significant proportion of patients with cancer-related pain are under-treated. There is a need for more effective control of cancer-related pain. Spinal cord stimulation (SCS) may have a role in pain management. The effectiveness and safety of SCS for patients with cancer-related pain is currently unknown. This systematic review evaluated the effectiveness of SCS for cancer-related pain compared with standard care using conventional analgesic medication. We also appraised risk and potential adverse events associated with the use of SCS. This is an update of a review first published in The Cochrane Library in Issue 3, 2013. The search strategy for the update was the same as in the original review. We searched the following bibliographic databases in order to identify relevant studies: the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library; MEDLINE; EMBASE; and CBM (Chinese Biomedical Database) in October 2014. We also handsearched relevant journals. There were no language restrictions. We planned to include randomised controlled trials (RCTs) that directly compared SCS with other interventions with regards to the effectiveness of pain management. We also planned to include cross-over trials that compared SCS with another treatment. We planned to identify non-randomised controlled trials but these would only be included if no RCTs could be found. The literature search for the update of this review found 121 potentially eligible articles. The initial search strategy yielded 430 articles. By scrutinising titles and abstracts, we found 412 articles irrelevant to the analytical purpose of this systematic review due to different scopes of diseases or different methods of intervention (intrathecal infusion system; oral medication) or aims other than pain control (spinal cord function monitoring, bladder function restoration or amelioration of organ metabolism). The remaining 18 trials were reviewed as full manuscripts. No RCTs were identified. Fourteen sporadic case reports and review articles were excluded and four before-and-after case series studies (92 participants) were included. Two review authors independently selected the studies to be included in the review according to the prespecified eligibility criteria. A checklist for methodological quality of non-randomised controlled trials was used (STROBE checklist) and all review authors discussed and agreed on the inclusion of trials and the results of the quality assessment. No new studies were identified for inclusion in this update of the review. Four before-and-after case series studies (a total of 92 participants) met our criteria for inclusion in the previous version of the review. All included trials adopted a visual analogue scale (VAS) to evaluate pain relief. Heterogeneity existed in terms of baseline characteristics, electrode and stimulator parameters, level of implantation and route of implantation; each trial reported data differently. In two trials, pain relief was achieved in 76% (48/63) of participants at the end of the follow-up period. In the third trial, pre-procedure VAS was 6 to 9 (mean 7.43 ); the one-month post-implant VAS was 2 to 4 (mean 3.07); the 12-month post-implant VAS was 1 to 3 (mean 2.67). In the fourth trial, the pre-procedure VAS was 6 to 9 (mean 7.07); 1 to 4 (mean 2.67) at one-month; 1 to 4 (mean 1.87) at 12 months. Analgesic use was largely reduced. The main adverse events were infection of sites of implantation, cerebrospinal fluid (CSF) leakage, pain at the sites of electrodes, dislodgement of the electrodes, and system failure; however, the incidence in participants with cancer could not be calculated. Since all trials were small, non-randomised controlled trials, they carried high or unclear risk of all types of bias. Since the first publication of this review, no new studies were identified. Current evidence is insufficient to establish the role of SCS in treating refractory cancer-related pain. Future randomised studies should focus on the implantation of SCS in participants with cancer-related pain.

Lead-related complications after DDD pacemaker implantation.

PubMed

Dębski, Maciej; Ulman, Mateusz; Ząbek, Andrzej; Boczar, Krzysztof; Haberka, Kazimierz; Kuniewicz, Marcin; Lelakowski, Jacek; Małecka, Barbara

2018-04-10

Pacing leads remain the weakest link in pacemaker systems despite advances in manufacturing technology. To assess the long-term pacing lead performance in an unselected real-life cohort following primary DDD pacing system implantation. A single-centre retrospective analysis of patients who underwent DDD pacing system implantation between October 1984 and December 2014 and were followed up until August 2016 was conducted. The inclusion criterion was at least one follow-up visit following post-implant discharge. The performance of each atrial and ventricular lead implanted was evaluated during the follow-up period, and the incidence of and predictive factors for lead dislodgement and failure were analysed. The data of 3771 patients and 24431.8 patient-years of follow-up were analysed. The mean follow-up of patients was 77.7 ± 61.8 months. During the study period, 7887 transvenous atrial and right ventricular pacing leads were implanted. Lead dislodgement occurred in 94 (1.2%) leads [92 (2.4%) patients], perforation in 11 (0.1%) leads [10 (0.3%) patients] and lead failure in 329 (4.2%) leads [275 (7.3%) patients]. Atrial lead position was a predictive factor for lead dislodgement, while age at implantation, polyurethane 80A insulation, subclavian vein access, unipolar lead construction and lead manufacturer were multivariate predictors of lead failure. Leads with polyurethane 80A insulation, unipolar construction and implantation via subclavian vein puncture exhibited the worst long-term performance.

Biological and technical complications and failures with fixed partial dentures (FPD) on implants and teeth after four to five years of function.

PubMed

Brägger, U; Aeschlimann, S; Bürgin, W; Hämmerle, C H; Lang, N P

2001-02-01

The aim of this study was to compare the frequency of biological and technical complications with fixed partial dentures (FPDs) on implants, teeth and as mixed tooth-implant supported FPDs over 4 to 5 years of function. All implants belonged to the ITI Dental Implant System. Group I-I (implant FPD) included 33 patients with 40 FPDs, group T-T (tooth FPDs) 40 patients with 58 FPDs, group I-T (mixed tooth-implant FPDs) 15 with 18 FPD. Of the bridge abutments 144 were teeth and 105 were implants. The median number of units replaced by the FPDs was 3 (range 2-14). The mean age of the patients was 55.7 years (range 23-83). Complete failures resulted in the loss of one FPD in each group. Two implants were lost due to fracture secondarily to development of a bone defect. One tooth had a vertical fracture and 1 tooth was lost due to periodontitis. Biological complications (peri-implantitis, PPD > or = 5 mm and BOP+) occurred at 9.6% (10) of the implants. This number was, however, reduced to 5% if the threshold for definition of peri-implantitis was set at PPD > or = 6 mm and BOP+. Biological complications occurred in 11.8% (17) of the abutment teeth (NS compared to implants); 2.8% (4) had secondary caries, 4.9% (7) endodontic problems and 4.1% (6) had periodontitis (PPD > or = 5 mm, BOP+). Ten out of 32 patients with a general health problem indicated a biological complication, whereas 9 out of 53 patients with no general health problem had a biological complication (chi 2: NS). Statistically significantly more technical complications were found in FPDs on implants (chi 2, P < or = 0.05). The technical complications were associated with bruxism. Out of 10 bruxers 6 had a technical complication whereas 13 out of 75 non-bruxers had such a complication (chi 2 < or = 0.01). Extensions were associated with more technical complications (13 out of 35 with extensions versus 9 out of 81 without). In conclusion, favourable clinical conditions were found at tooth and implant abutments after 4-5 years of function. Loss of FPD over 4-5 years occurred at a similar rate with mixed, implant or tooth supported reconstructions. Significantly more porcelain fractures were found in FPDs on implants. Impaired general health status was not significantly associated with more biological failures but bruxism as well as extensions were associated with more technical failures.

Does autoimmunity play a role in the risk of implantation failures?

PubMed

Motak-Pochrzest, Hanna; Malinowski, Andrzej

2018-02-01

158 non-pregnant women with recurrent implantation failures after IVF/ET procedures were tested for peripheral blood autoimmune profile. The control group consisted of 76 patients after first successful IVF procedure and pregnancy outcome. The objective of this study was to investigate different autoantibodies peripheral blood profile after excluding anatomical, endocrinological, endometrial and genetic disorders and to estimate the risk of implantation failures. The study's including criteria were 1.indications for IVF/ET determined by male factor and unexplained infertility 2. absence of implantation after two consecutive cycles of IVF, ICSI or frozen embryo replacement cycles. The presence of ANA in the sera increased the risk of RIF after ET/IVF procedures, especially in older patients. Patients with RIF have a higher frequency of the presence of autoantibodies ACA IgG, IgM and anti-β2GP I IgG in the sera than in patients with successful pregnancies after IVF/ET procedures.

Implantation failure in mice with a disruption in Phospholipase C beta 1 gene: lack of embryonic attachment, aberrant steroid hormone signalling and defective endocannabinoid metabolism

PubMed Central

Filis, Panayiotis; Kind, Peter C.; Spears, Norah

2013-01-01

Phospholipase C beta 1 (PLCβ1) is a downstream effector of G-protein-coupled receptor signalling and holds central roles in reproductive physiology. Mice with a disruption in the Plcβ1 gene are infertile with pleiotropic reproductive defects, the major reproductive block in females being implantation failure. Here, PLCβ1 was demonstrated at the luminal and glandular epithelia throughout the pre- and peri-implantation period, with transient stromal expression during 0.5–1.5 days post coitum (dpc). Examination of implantation sites at 4.5 dpc showed that in females lacking functional PLCβ1 (knock-out (KO) females), embryos failed to establish proper contact with the uterine epithelium. Proliferating luminal epithelial cells were evident in KO implantation sites, indicating failure to establish a receptive uterus. Real-time PCR demonstrated that KO implantation sites had aberrant ovarian steroid signalling, with high levels of estrogen receptor α, lactoferrin and amphiregulin mRNA, while immunohistochemistry revealed very low levels of estrogen receptor α protein, possibly due to rapid receptor turnover. KO implantation sites expressed markedly less fatty acid amide hydrolase and monoacylglycerol lipase, indicating that endocannabinoid metabolism was also affected. Collectively, our results show that PLCβ1 is essential for uterine preparation for implantation, and that defective PLCβ1-mediated signalling during implantation is associated with aberrant ovarian steroid signalling and endocannabinoid metabolism. PMID:23295235

Unified Approach to the Biomechanics of Dental Implantology

NASA Technical Reports Server (NTRS)

Grenoble, D. E.; Knoell, A. C.

1973-01-01

The human need for safe and effective dental implants is well-recognized. Although many implant designs have been tested and are in use today, a large number have resulted in clinical failure. These failures appear to be due to biomechanical effects, as well as biocompatibility and surgical factors. A unified approach is proposed using multidisciplinary systems technology, for the study of the biomechanical interactions between dental implants and host tissues. The approach progresses from biomechanical modeling and analysis, supported by experimental investigations, through implant design development, clinical verification, and education of the dental practitioner. The result of the biomechanical modeling, analysis, and experimental phases would be the development of scientific design criteria for implants. Implant designs meeting these criteria would be generated, fabricated, and tested in animals. After design acceptance, these implants would be tested in humans, using efficient and safe surgical and restorative procedures. Finally, educational media and instructional courses would be developed for training dental practitioners in the use of the resulting implants.

Case presentation of florid cemento-osseous dysplasia with concomitant cemento-ossifying fibroma discovered during implant explantation.

PubMed

Gerlach, Robert C; Dixon, Douglas R; Goksel, Tamer; Castle, James T; Henry, Walter A

2013-03-01

A 39-year-old African American woman presented for treatment of a symptomatic mandibular right first molar with a large, periapical radiolucency. After initial attempts at endodontic therapy, this tooth was ultimately extracted owing to unabated symptoms. The extraction site underwent ridge preservation grafting, implant placement, and restoration. After 26 months of implant function, the patient returned with clinical symptoms of pain, buccal swelling, and the sensation of a "loose" implant. This case report details a diagnosis of 2 distinct disease entities associated with the implant site, a cemento-ossifying fibroma and florid cemento-osseous dysplasia of the mandible. This diagnosis was determined from clinical, surgical, radiographic, and histopathologic evidence after biopsy and removal of the previously osseointegrated implant following postinsertion failure by fibrous encapsulation. Before implant therapy, it is essential to conduct a thorough radiographic evaluation of any dental arch with suspected bony lesions to prevent implant failure. Published by Mosby, Inc.

Factors affecting the outcome of "endometrial scratch" in women with recurrent implantation failure.

PubMed

Coughlan, Carol; Yuan, Xi; Demirol, Aygul; Ledger, William; Li, Tin Chiu

2014-01-01

To examine factors affecting the outcome of the endometrial scratch in women with recurrent implantation failure. A total of 57 eligible patients with a history of recurrent implantation failure underwent an endometrial biopsy in the luteal phase of the menstrual cycle in the month immediately preceding the embryo transfer cycle. The comparative group consisted of a retrospective cohort of 66 women with recurrent implantation failure but without endometrial biopsy. There were no significant differences between the intervention and control groups in terms of age, follicle-stimulating hormone (FSH), free androgen index, anti-Müllerian hormone, body mass index, the number of embryos transferred, and the number of embryo transfer cycles. The clinical pregnancy rate in the intervention group (53%) was significantly (p < 0.001) higher than that of the control group (15%). The only predictive factor was FSH. Women with FSH < or =10 IU/L had a pregnancy rate of 57.8%, significantly (p < 0.05) higher than that (20%) of women with FSH >10 IU/L. Women with a normal FSH are more likely to derive benefit from endometrial scratch.

PFC knee replacement: osteolytic failures from extreme polyethylene degradation.

PubMed

Casey, David; Cottrell, Jocelyn; DiCarlo, Edward; Windsor, Russell; Wright, Timothy

2007-11-01

Despite the long-term success of press-fit condylar (PFC) knee prostheses, premature failures caused by aggressive rapid osteolysis have been reported. To investigate why patients experience such failures, we reviewed 48 retrieved implants and surrounding tissues together with demographic and radiographic data. Polyethylene degradation was determined from density profiles taken through the retrieved inserts. We compared the histology of tissues around PFC implants with that from around failed implants of similar designs from patients matched to length of implantation, body mass index, and age. The pathologic response in PFC patients showed more widespread, dense, sheet-like cellular infiltrate, whereas in the matched patients, the infiltrate was generally scattered discontinuously. The dominant wear mode of the PFC inserts was severe delamination on the articular surfaces. Wear damage was worse with increased length of implantation and was correlated with oxidative degradation and osteolysis. Degradation and osteolysis were more severe with inserts stored longer and sterilized by gamma radiation in air. These results underscore that degradation and increased shelf life lead to osteolysis and loosening. However, they raise questions concerning the cellular reaction to the debris from PFC implants that could lead to a better general understanding of osteolysis.

Failure modes of Y-TZP abutments with external hex implant-abutment connection determined by fractographic analysis.

PubMed

Basílio, Mariana de Almeida; Delben, Juliana Aparecida; Cesar, Paulo Francisco; Rizkalla, Amin Sami; Santos Junior, Gildo Coelho; Arioli Filho, João Neudenir

2016-07-01

Yttria-stabilized tetragonal zirconia (Y-TZP) was introduced as ceramic implant abutments due to its excellent mechanical properties. However, the damage patterns for Y-TZP abutments are limited in the literature. Fractographic analyses can provide insights as to the failure origin and related mechanisms. The purpose of this study was to analyze fractured Y-TZP abutments to establish fractographic patterns and then possible reasons for failure. Thirty two prefabricated Y-TZP abutments on external hex implants were retrieved from a single-load-to failure test according to the ISO 14801. Fractographic analyses were conducted under polarized-light estereo and scanning electro microscopy. The predominant fracture pattern was abutment fracture at the connecting region. Classic fractographic features such as arrest lines, hackle, and twist hackle established that failure started where Y-TZP abutments were in contact with the retention screw edges. The abutment screw design and the loading point were the reasons for localized stress concentration and fracture patterns. Copyright © 2016 Elsevier Ltd. All rights reserved.

Continuous internal counterpulsation as a bridge to recovery in acute and chronic heart failure

PubMed Central

Kontogiannis, Christos D; Malliaras, Konstantinos; Kapelios, Chris J; Mason, Jay W; Nanas, John N

2016-01-01

Cardiac recovery from cardiogenic shock (CS) and end-stage chronic heart failure (HF) remains an often insurmountable therapeutic challenge. The counterpulsation technique exerts numerous beneficial effects on systemic hemodynamics and left ventricular mechanoenergetics, rendering it attractive for promoting myocardial recovery in both acute and chronic HF. Although a recent clinical trial has questioned the clinical effectiveness of short-term hemodynamic support with intra-aortic balloon pump (IABP, the main representative of the counterpulsation technique) in CS complicating myocardial infarction, the issue remains open to further investigation. Moreover, preliminary data suggest that long-term IABP support in patients with end-stage HF is safe and may mediate recovery of left- or/and right-sided cardiac function, facilitating long-term weaning from mechanical support or enabling the application of other permanent, life-saving solutions. The potential of long-term counterpulsation could possibly be enhanced by implementation of novel, fully implantable counterpulsation devices. PMID:27011909

Is intracytoplasmic morphologically selected sperm injection (IMSI) beneficial in the first ART cycle? a multicentric randomized controlled trial.

PubMed

Leandri, R D; Gachet, A; Pfeffer, J; Celebi, C; Rives, N; Carre-Pigeon, F; Kulski, O; Mitchell, V; Parinaud, J

2013-09-01

Intracytoplasmic morphologically selected sperm injection (IMSI), by selecting spermatozoa at high magnification improves the outcome of intracytoplasmic sperm injection (ICSI) mainly after several failures. However, only few monocentric randomized studies are available and they do not analyse results as a function of sperm characteristics. In 255 couples attempting their first assisted reproductive technology (ART) attempt for male infertility (motile sperm count <1×10⁶ after sperm selection, but at least 3×10⁶ spermatozoa per ejaculate to allow a detailed analysis of sperm characteristics), a prospective randomized trial was performed to compare the clinical outcomes of IMSI and ICSI and to evaluate the influence of sperm characteristics on these outcomes. IMSI did not provide any significant improvement in the clinical outcomes compared with ICSI neither for implantation (24% vs. 23%), nor clinical pregnancy (31% vs. 33%) nor live birth rates (27% vs. 30%). Moreover, the results of IMSI were similar to the ICSI ones whatever the degree of sperm DNA fragmentation, nuclear immaturity and sperm morphology. These results show that IMSI instead of ICSI has no advantage in the first ART attempts. However, this does not rule out IMSI completely and more randomized trials must be performed especially regarding patients carrying severe teratozoospermia, or high sperm DNA fragmentation levels or having previous ICSI failures. © 2013 American Society of Andrology and European Academy of Andrology.

Comparisons of maximum deformation and failure forces at the implant–abutment interface of titanium implants between titanium-alloy and zirconia abutments with two levels of marginal bone loss

PubMed Central

2013-01-01

Background Zirconia materials are known for their optimal aesthetics, but they are brittle, and concerns remain about whether their mechanical properties are sufficient for withstanding the forces exerted in the oral cavity. Therefore, this study compared the maximum deformation and failure forces of titanium implants between titanium-alloy and zirconia abutments under oblique compressive forces in the presence of two levels of marginal bone loss. Methods Twenty implants were divided into Groups A and B, with simulated bone losses of 3.0 and 1.5 mm, respectively. Groups A and B were also each divided into two subgroups with five implants each: (1) titanium implants connected to titanium-alloy abutments and (2) titanium implants connected to zirconia abutments. The maximum deformation and failure forces of each sample was determined using a universal testing machine. The data were analyzed using the nonparametric Mann–Whitney test. Results The mean maximum deformation and failure forces obtained the subgroups were as follows: A1 (simulated bone loss of 3.0 mm, titanium-alloy abutment) = 540.6 N and 656.9 N, respectively; A2 (simulated bone loss of 3.0 mm, zirconia abutment) = 531.8 N and 852.7 N; B1 (simulated bone loss of 1.5 mm, titanium-alloy abutment) = 1070.9 N and 1260.2 N; and B2 (simulated bone loss of 1.5 mm, zirconia abutment) = 907.3 N and 1182.8 N. The maximum deformation force differed significantly between Groups B1 and B2 but not between Groups A1 and A2. The failure force did not differ between Groups A1 and A2 or between Groups B1 and B2. The maximum deformation and failure forces differed significantly between Groups A1 and B1 and between Groups A2 and B2. Conclusions Based on this experimental study, the maximum deformation and failure forces are lower for implants with a marginal bone loss of 3.0 mm than of 1.5 mm. Zirconia abutments can withstand physiological occlusal forces applied in the anterior region. PMID:23688204

Ultrasound guided aspiration of hydrosalpinx fluid versus salpingectomy in the management of patients with ultrasound visible hydrosalpinx undergoing IVF-ET: a randomized controlled trial.

PubMed

Fouda, Usama M; Sayed, Ahmed M; Abdelmoty, Hatem I; Elsetohy, Khaled A

2015-01-01

The aim of this study was to compare the efficacy of ultrasound guided aspiration of hydrosalpinx fluid at the time of oocyte retrieval with salpingectomy in the management of patients with ultrasound visible hydrosalpinx undergoing IVF-ET. One hundred and sixty patients with ultrasound visible hydrosalpinx were randomized into salpingectomy group and aspiration group using computer generated randomization list and sequentially numbered sealed envelopes containing allocation information written on a card. The clinical pregnancy rate per started cycle and the implantation rate were non- significantly higher in the salpingectomy group compared with the aspiration group [40% vs. 27.5% (p value = 0.132) and 18.95% vs. 12.82% (p value =0.124), respectively]. In the aspiration group, 34.21% of patients had rapid re-accumulation of the hydrosalpinx fluid (i.e. within first two weeks after embryo transfer). Whereas, the clinical pregnancy rate per transfer cycle and the implantation rate were significantly higher in salpingectomy group compared with the subgroup of patients with rapid re-accumulation of hydrosalpinx fluid [42.67% vs. 19.23% (p value = 0.036) and 18.95% vs. 7.58% (p value = 0.032), respectively], no significant differences were detected between the salpingectomy group and the subgroup of patients with no re-accumulation of hydrosalpinx fluid (42.67% vs. 34% (p value = 0.356) and 18.95% vs. 15.5% (p value = 0.457), respectively). The small sample size could be the cause of failure of detecting significant increase in implantation and pregnancy rates in salpingectomy group compared with aspiration group. Further larger randomized controlled trials are needed to determine whether salpingectomy is more effective than aspiration of hydrosalpinx fluid or not. Moreover, the data presented in this study suggested that rapid re-accumulation of hydrosalpinx fluid is an obstacle against successful implantation and the cause of lower success rate with ultrasound guided aspiration of hydrosalpinx fluid compared with salpingectomy. Clinical trials.gov ( NCT02008240 ), registered 8 December 2013.

Does plate type influence the clinical outcomes and implant removal in midclavicular fractures fixed with 2.7-mm anteroinferior plates? A retrospective cohort study

PubMed Central

2014-01-01

Background The purpose of this study was to evaluate surgical healing rates, implant failure, implant removal, and the need for surgical revision with regards to plate type in midshaft clavicle fractures fixed with 2.7-mm anteroinferior plates utilizing modern plating techniques. Methods This retrospective exploratory cohort review took place at a level I teaching trauma center and a single large private practice office. A total of 155 skeletally mature individuals with 156 midshaft clavicle fractures between March 2002 and March 2012 were included in the final results. Fractures were identified by mechanism of injury and classified based on OTA/AO criteria. All fractures were fixed with 2.7-mm anteroinferior plates. Primary outcome measurements included implant failure, malunion, nonunion, and implant removal. Secondary outcome measurements included pain with the visual analog scale and range of motion. Statistically significant testing was set at 0.05, and testing was performed using chi-square, Fisher’s exact, Mann–Whitney U, and Kruskall-Wallis. Results Implant failure occurred more often in reconstruction plates as compared to dynamic compression plates (p = 0.029). Malunions and nonunions occurred more often in fractures fixed with reconstruction plates as compared to dynamic compression plates, but it was not statistically significant. Implant removal attributed to irritation or implant prominence was observed in 14 patients. Statistically significant levels of pain were seen in patients requiring implant removal (p = 0.001) but were not associated with the plate type. Conclusions Anteroinferior clavicular fracture fixation with 2.7-mm dynamic compression plates results in excellent healing rates with low removal rates in accordance with the published literature. Given higher rates of failure, 2.7-mm reconstruction plates should be discouraged in comparison to stiffer and more reliable 2.7-mm dynamic compression plates. PMID:24993508

Long-term cumulative survival and mechanical complications of single-tooth Ankylos Implants: focus on the abutment neck fractures

PubMed Central

2015-01-01

PURPOSE To evaluate the cumulative survival rate (CSR) and mechanical complications of single-tooth Ankylos® implants. MATERIALS AND METHODS This was a retrospective clinical study that analyzed 450 single Ankylos® implants installed in 275 patients between December 2005 and December 2012. The main outcomes were survival results CSR and implant failure) and mechanical complications (screw loosening, fracture, and cumulative fracture rate [CFR]). The main outcomes were analyzed according to age, sex, implant length or diameter, bone graft, arch, and position. RESULTS The 8-year CSR was 96.9%. Thirteen (2.9%) implants failed because of early osseointegration failure in 3, marginal bone loss in 6, and abutment fracture in 4. Screw loosening occurred in 10 implants (2.2%), and 10 abutment fractures occurred. All abutment fractures were located in the neck, and concurrent screw fractures were observed. The CSR and rate of screw loosening did not differ significantly according to factors. The CFR was higher in middle-aged patients (5.3% vs 0.0% in younger and older patients); for teeth in a molar position (5.8% vs 0.0% for premolar or 1.1% for anterior position); and for larger-diameter implants (4.5% for 4.5 mm and 6.7% for 5.5 mm diameter vs 0.5% for 3.5 mm diameter) (all P<.05). CONCLUSION The Ankylos® implant is suitable for single-tooth restoration in Koreans. However, relatively frequent abutment fractures (2.2%) were observed and some fractures resulted in implant failures. Middle-aged patients, the molar position, and a large implant diameter were associated with a high incidence of abutment fracture. PMID:26813443

Long-term cumulative survival and mechanical complications of single-tooth Ankylos Implants: focus on the abutment neck fractures.

PubMed

Shim, Hye Won; Yang, Byoung-Eun

2015-12-01

To evaluate the cumulative survival rate (CSR) and mechanical complications of single-tooth Ankylos® implants. This was a retrospective clinical study that analyzed 450 single Ankylos® implants installed in 275 patients between December 2005 and December 2012. The main outcomes were survival results CSR and implant failure) and mechanical complications (screw loosening, fracture, and cumulative fracture rate [CFR]). The main outcomes were analyzed according to age, sex, implant length or diameter, bone graft, arch, and position. The 8-year CSR was 96.9%. Thirteen (2.9%) implants failed because of early osseointegration failure in 3, marginal bone loss in 6, and abutment fracture in 4. Screw loosening occurred in 10 implants (2.2%), and 10 abutment fractures occurred. All abutment fractures were located in the neck, and concurrent screw fractures were observed. The CSR and rate of screw loosening did not differ significantly according to factors. The CFR was higher in middle-aged patients (5.3% vs 0.0% in younger and older patients); for teeth in a molar position (5.8% vs 0.0% for premolar or 1.1% for anterior position); and for larger-diameter implants (4.5% for 4.5 mm and 6.7% for 5.5 mm diameter vs 0.5% for 3.5 mm diameter) (all P<.05). The Ankylos® implant is suitable for single-tooth restoration in Koreans. However, relatively frequent abutment fractures (2.2%) were observed and some fractures resulted in implant failures. Middle-aged patients, the molar position, and a large implant diameter were associated with a high incidence of abutment fracture.

Phrenic nerve stimulation for the treatment of central sleep apnea.

PubMed

Abraham, William T; Jagielski, Dariusz; Oldenburg, Olaf; Augostini, Ralph; Krueger, Steven; Kolodziej, Adam; Gutleben, Klaus-Jürgen; Khayat, Rami; Merliss, Andrew; Harsch, Manya R; Holcomb, Richard G; Javaheri, Shahrokh; Ponikowski, Piotr

2015-05-01

The aim of this study was to evaluate chronic, transvenous, unilateral phrenic nerve stimulation to treat central sleep apnea (CSA) in a prospective, multicenter, nonrandomized study. CSA occurs predominantly in patients with heart failure and increases the risk for morbidity and mortality. Established therapies for CSA are lacking, and those available are limited by poor patient adherence. Fifty-seven patients with CSA underwent baseline polysomnography followed by transvenous phrenic nerve stimulation system implantation and follow-up. Feasibility was assessed by implantation success rate and therapy delivery. Safety was evaluated by monitoring of device- and procedure-related adverse events. Efficacy was evaluated by changes in the apnea-hypopnea index at 3 months. Quality of life at 6 months was evaluated using a sleepiness questionnaire, patient global assessment, and, in patients with heart failure at baseline, the Minnesota Living With Heart Failure Questionnaire. The study met its primary end point, demonstrating a 55% reduction in apnea-hypopnea index from baseline to 3 months (49.5 ± 14.6 episodes/h vs. 22.4 ± 13.6 episodes/h of sleep; p < 0.0001; 95% confidence interval for change: -32.3 to -21.9). Central apnea index, oxygenation, and arousals significantly improved. Favorable effects on quality of life and sleepiness were noted. In patients with heart failure, the Minnesota Living With Heart Failure Questionnaire score significantly improved. Device- or procedure-related serious adverse events occurred in 26% of patients through 6 months post therapy initiation, predominantly due to lead repositioning early in the study. Therapy was well tolerated. Efficacy was maintained at 6 months. Transvenous, unilateral phrenic nerve stimulation appears safe and effective for treating CSA. These findings should be confirmed in a prospective, randomized, controlled trial. (Chronic Evaluation of Respicardia Therapy; NCT01124370). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Hip Implant Modified To Increase Probability Of Retention

NASA Technical Reports Server (NTRS)

Canabal, Francisco, III

1995-01-01

Modification in design of hip implant proposed to increase likelihood of retention of implant in femur after hip-repair surgery. Decreases likelihood of patient distress and expense associated with repetition of surgery after failed implant procedure. Intended to provide more favorable flow of cement used to bind implant in proximal extreme end of femur, reducing structural flaws causing early failure of implant/femur joint.

Recommended placement torque when tightening an orthodontic mini-implant.

PubMed

Motoyoshi, Mitsuru; Hirabayashi, Masayuki; Uemura, Miwa; Shimizu, Noriyoshi

2006-02-01

To determine an adequate placement torque for obtaining a better success rate of mini-implants that are screwed into the buccal alveolar bone of the posterior region as an anchor for orthodontic treatment, implant placement torque (IPT) was measured. The subjects were 41 orthodontic patients (124 implants), with an average age of 24.9 years (SD 6.5 years), who had surgery to place titanium mini-implants. The peak value of IPT was measured using a torque screwdriver. The success rate of the mini-implant anchor for 124 implants was 85.5%. The mean IPT ranged from 7.2 to 13.5 N cm, depending on the location of the implants. There was a significant difference in the IPT between maxilla and mandible. The IPT in the mandible was, unexpectedly, significantly higher in the failure group than in the success group. Therefore, a large IPT should not be used always. According to our calculations of the risk ratio for failure, to raise the success rate of 1.6-mm diameter mini-implants, the recommended IPT is within the range from 5 to 10 N cm.

Scientific Fundamentals and Technological Development of Novel Biocompatible/Corrosion Resistant Ultrananocrystalline Diamond (UNCD) Coating Enabling Next Generation Superior Metal-Based Dental Implants

NASA Astrophysics Data System (ADS)

Kang, Karam

Current Ti-based dental implants exhibit failure (2-10%), due to various mechanisms, including chemical corrosion of the surface of the TiO2 naturally covered Ti-based implants. This thesis focused on developing a unique biocompatible/bio-inert/corrosion resistant/low cost Ultrananocrystalline Diamond (UNCD) coating (with 3-5 nm grain size) for encapsulation of Tibased micro-implants to potentially eliminate the corrosion/mechanical induced failure of current commercial Ti-based dental implants. Microwave Plasma Chemical Vapor Deposition (MPCVD) and Hot Filament Chemical Vapor Deposition (HFCVD) processes were used to grow UNCD coatings. The surface topography and chemistry of UNCD coatings were characterized using scanning electron microscopy (SEM), Raman, and X-ray photoelectron spectroscopies (XPS) respectively. In conclusion, this thesis contributed to establish the optimal conditions to grow UNCD coatings on the complex 3-D geometry of Ti-based micro-implants, with geometry similar to real implants, relevant to developing UNCD-coated Ti-based dental implants with superior mechanical/chemical performance than current Ti-based implants.

Total artificial heart implantation for biventricular failure due to eosinophilic myocarditis.

PubMed

Kawabori, Masashi; Kurihara, Chitaru; Miller, Yair; Heck, Kent A; Bogaev, Roberta C; Civitello, Andrew B; Cohn, William E; Frazier, O H; Morgan, Jeffrey A

2017-09-01

Idiopathic hypereosinophilic syndrome is a condition of unknown etiology characterized by proliferation of eosinophils and their infiltration into tissues. Although cardiac involvement is rare, eosinophilic myocarditis can lead to life-threating fulminant congestive heart failure. Treatment of patients with eosinophilic myocarditis is challenging as heart failure can be caused by biventricular dysfunction. To our knowledge, this is the first case reported in the literature describing a patient with acute severe biventricular heart failure caused by eosinophilic myocarditis with mural left ventricular apical thrombus who was successfully treated with implantation of a total artificial heart as a bridge to heart transplant.

Twiddler's syndrome in spinal cord stimulation.

PubMed

Al-Mahfoudh, Rafid; Chan, Yuen; Chong, Hsu Pheen; Farah, Jibril Osman

2016-01-01

The aims are to present a case series of Twiddler's syndrome in spinal cord stimulators with analysis of the possible mechanism of this syndrome and discuss how this phenomenon can be prevented. Data were collected retrospectively between 2007 and 2013 for all patients presenting with failure of spinal cord stimulators. The diagnostic criterion for Twiddler's syndrome is radiological evidence of twisting of wires in the presence of failure of spinal cord stimulation. Our unit implants on average 110 spinal cord stimulators a year. Over the 5-year study period, all consecutive cases of spinal cord stimulation failure were studied. Three patients with Twiddler's syndrome were identified. Presentation ranged from 4 to 228 weeks after implantation. Imaging revealed repeated rotations and twisting of the wires of the spinal cord stimulators leading to hardware failure. To the best of our knowledge this is the first reported series of Twiddler's syndrome with implantable pulse generators (IPGs) for spinal cord stimulation. Hardware failure is not uncommon in spinal cord stimulation. Awareness and identification of Twiddler's syndrome may help prevent its occurrence and further revisions. This may be achieved by implanting the IPG in the lumbar region subcutaneously above the belt line. Psychological intervention may have a preventative role for those who are deemed at high risk of Twiddler's syndrome from initial psychological screening.

Risk Factors for Treatment Failure With the Adjustable Transobturator Male System Incontinence Device: Who Will Succeed, Who Will Fail? Results of a Multicenter Study.

PubMed

Friedl, Alexander; Mühlstädt, Sandra; Rom, Maximilian; Kivaranovic, Danijel; Mohammed, Nasreldin; Fornara, Paolo; Brössner, Clemens

2016-04-01

To identify risk factors for treatment failure of men with the adjustable transobturator male system (ATOMS) for treating stress urinary incontinence (SUI). Sixty-two patients with SUI after prostate surgery were provided with an ATOMS. The self-defined criteria for treatment failure (implant removal [A], no improvement or ≥3 pads/24 hours [B], and no improvement or ≥150 mL urine loss/24 hours [C]) were compared to anamnestic, clinical, and time-specific parameters: age, Charlson comorbidity index (CCI), urine culture (UC), previous ineffective implants, body mass index, radiotherapy, renal function (serum creatinine), smoker status, urethral strictures, SUI severity, surgery time, time to and season at implantation, and port system application. After a median follow-up of 17.7 months, 9 ATOMS (15%) were removed due to infection (8) or dysfunction (1); 23% and 16% had treatment failure of criteria B and C. Dry rate/overall success rate was 61%/87%. Age alone was no risk factor but the CCI and a positive UC were univariate significant predictors of the criteria A, B, and C. Besides, previous devices and renal failure were significantly associated with implant removal (A) and SUI severity with criterion C. In multivariate analysis, previous devices (P = .0163), positive UC (P = .0190), and SUI severity (P = .0123) were the strongest predictors of A, B, and C, respectively. A poor CCI, preoperative positive UC, severe SUI, and previous implants lead to more treatment failure and removal. Age, body mass index, radiotherapy, urethral strictures, current smoking, time-specific parameters, seasonality, and port system application did not influence the outcome. Copyright © 2016 Elsevier Inc. All rights reserved.

Design and Evaluation of a Fully Implantable Control Unit for Blood Pumps

PubMed Central

Unthan, Kristin; Gräf, Felix; Laumen, Marco; Finocchiaro, Thomas; Sommer, Christoph; Lanmüller, Hermann; Steinseifer, Ulrich

2015-01-01

As the number of donor hearts is limited while more and more patients suffer from end stage biventricular heart failure, Total Artificial Hearts become a promising alternative to conventional treatment. While pneumatic devices sufficiently supply the patients with blood flow, the patient's quality of life is limited by the percutaneous pressure lines and the size of the external control unit. This paper describes the development of the control unit of the ReinHeart, a fully implantable Total Artificial Heart. General requirements for any implantable control unit are defined from a technical and medical point of view: necessity of a Transcutaneous Energy Transmission, autonomous operation, safety, geometry, and efficiency. Based on the requirements, a prototype is designed; it incorporates a LiFePo4 battery pack with charger, a rectifier for transcutaneous energy transmission, the motor's driver electronics, and a microcontroller which monitors and controls all functions. In validation tests, the control unit demonstrated a stable operation on TET and battery supply and a safe switching from one supply to the other. The overall mean efficiency is 14% on TET and 22% on battery supply. The control unit is suitable for chronic animal trials of the ReinHeart. PMID:26583095

Risk of Sprint Fidelis defibrillator lead failure is highly dependent on age.

PubMed

Girerd, Nicolas; Nonin, Emilie; Pinot, Julien; Morel, Elodie; Flys, Carine; Scridon, Alina; Chevalier, Philippe

2011-01-01

In 2007, Medtronic Sprint Fidelis defibrillator leads were taken off the market due to a high rate of lead failure. Current data do not allow for risk stratification of patients with regard to lead failure. We sought to determine predictors of Sprint Fidelis lead failure. Between 2004 and 2007, 269 Sprint Fidelis leads were implanted in 258 patients in our centre. Variables associated with lead failure were assessed by the Kaplan-Meier method and a Cox survival model. During a median follow-up of 2.80 years (maximum 5.32), we observed 33 (12.3%) Sprint Fidelis lead failures (5-year survival, 65.6% ± 7.5%). In univariate analysis, age was the only predictor of lead failure (hazard ratio [HR] for 1-year increase 0.97; 95% confidence interval [CI] 0.95-0.99; p=0.009). Patients aged<62.5 years (median) had a significantly increased risk of lead failure compared with patients aged>62.5 years (HR 2.80; CI 1.30-6.02; p=0.009). Survival without Sprint Fidelis lead failure was 55.6% ± 10.4%) in patients aged<62.5 years (24/134 leads) vs 78.6% ± 8.8% in patients aged>62.5 years (9/135 leads). The annual incidence of lead failure in patients aged<62.5 years was 11.6% ± 4.9% during the fourth year after implantation and 22.9% ± 13.2% during the fifth year. Overall, we found a higher rate of Sprint Fidelis lead dysfunction than previously described. Lead failure was much more frequent in younger patients. Our results emphasize the need for close follow-up of younger patients with Sprint Fidelis leads and suggest that, in these patients, the implantation of a new implantable cardioverter defibrillator lead at the time of generator replacement might be reasonable. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

Use of Compressive Osseointegration Endoprostheses for Massive Bone Loss From Tumor and Failed Arthroplasty: A Viable Option in the Upper Extremity.

PubMed

Goulding, Krista A; Schwartz, Adam; Hattrup, Steven J; Randall, R Lor; Lee, Donald; Rispoli, Damian M; Lerman, Daniel M; Beauchamp, Christopher

2017-06-01

Endoprostheses using principles of compressive osseointegration have shown good survivorship in several studies involving the lower extremity; however, no series to our knowledge have documented the use of this technology in the management of massive bone loss in the upper limb. (1) What proportion of upper extremity implants using compressive osseointegration fixation principles achieved durable short-term fixation, and what were the modes of failure? (2) What surgical complications resulted from reconstruction using this technique? A multiinstitutional retrospective review identified nine patients (five women; four men) who underwent 13 endoprosthetic replacements between 2003 and 2014 using compressive osseointegration (Compliant ® Pre-stress Device [CPS]; Biomet Inc, Warsaw, IN, USA) in the upper extremity, including two proximal humeri, two humeral diaphyses, seven distal humeri, and two proximal ulna. During the early part of that period, the indication for use of a compressive prosthesis in our centers was revision of a previous tumor reconstruction (allograft-prosthetic composite or stemmed endoprosthetic reconstruction) (three patients; five implants), or revision arthroplasty with massive bone loss (three patients, four implants); more recently, indications became somewhat more permissive and included posttraumatic bone loss (one patient, one implant), primary bone sarcoma, and resections with very short remaining end segments after diaphyseal resections (two patients, three implants). Minimum followup was 24 months; one patient (one implant) was lost to followup before that time with the implant intact at 14 months and no patients have died. The mean age of the patients was 45 years (range, 21-62 years). Mean followup was 68 months (range, 24-141 months). Implant revision for any cause and for failure of the CPS mechanism was recorded. Modes of failure were categorized as soft tissue, aseptic loosening, structural, infection, and tumor progression; CPS modes of failure were defined as lack of fixation, with or without bone or implant fracture. Of the 12 implants accounted for beyond 2 years, six had undergone revision of any kind. Only two revisions in two patients were attributable to lack of CPS fixation at the bone-implant interface; one of the patients also had periprosthetic and implant fracture develop through the traction bar. Other modes of failure were aseptic loosening of the standard ulnar component (two patients, two implants), bushing wear (one patient; one implant) and infection resulting in two-stage exchange and free soft tissue transfer with retention of the CPS spindle (one patient, one implant). Complications for all nine patients included one transient radial nerve palsy, one ulnar nerve sensory neurapraxia, one superficial infection, and two glenohumeral subluxations, one underwent revision surgery with implantation of a constrained liner. A compressive osseointegration endoprosthesis is an option for very difficult revisions or sarcoma resection in the upper extremity in which the remaining segment of host bone is too short for a conventional prosthesis. However, surgeons must inform patients that these are salvage operations, and revision surgery is common. Long-term followup of more patients is necessary to further document the survivorship of these implants in the upper extremity. Level IV, therapeutic study.

Randomized study on the effect of single-implant versus two-implant retained overdentures on implant loss and muscle activity: a 12-month follow-up report.

PubMed

Alqutaibi, A Y; Kaddah, A F; Farouk, M

2017-06-01

The objective was to evaluate and compare single- and two-implant retained overdentures for the rehabilitation of the edentulous mandible. Fifty-six edentulous subjects were eligible for inclusion. Using a random sampling system, a single implant or two implants were placed in the mandible. After 3 months, locator attachments were connected to the implants and the denture delivered with the retentive components incorporated in the denture base. Implant failure and muscle activity were evaluated at the 3-, 6-, and 12-month follow-up examinations. The study sample comprised 56 patients (32 male, 24 female), with a mean age of 58.2 years. A total of 84 implants were placed (28 in the single-implant group and 56 in the two-implant group). All patients completed the 12 months of follow-up. No significant differences were found between subjects in the two groups with respect to implant failure. With regard to improvements in muscle activity, the two-implant group showed statistically significant but perhaps not clinically important differences. Single-implant mandibular overdentures may be suggested as an alternative treatment modality for the rehabilitation of edentulous patients who cannot afford the cost of a two-implant overdenture. Copyright © 2017 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Therapeutic Approach to Patients with Heart Failure with Reduced Ejection Fraction and End-stage Renal Disease.

PubMed

Inampudi, Chakradhari; Alvarez, Paulino; Asleh, Rabea; Briasoulis, Alexandros

2018-03-14

Several risk factors including Ischemic heart disease, uncontrolled hypertension, high output Heart Failure (HF) from shunting through vascular hemodialysis access, and anemia, contribute to development of HF in patients with End-Stage Renal Disease (ESRD). Guidelinedirected medical and device therapy for Heart Failure with Reduced Ejection Fraction (HFrEF) has not been extensively studied and may have limited safety and efficacy in patients with ESRD. Maintenance of interdialytic and intradialytic euvolemia is a key component of HF management in these patients but often difficult to achieve. Beta-blockers, especially carvedilol which is poorly dialyzed is associated with cardiovascular benefit in this population. Despite paucity of data, Angiotensin-converting Enzyme Inhibitors (ACEI) or Angiotensin II Receptor Blockers (ARBs) when appropriately adjusted by dose and with close monitoring of serum potassium can also be administered to these patients who tolerate beta-blockers. Mineralocorticoid receptors in patients with HFrEF and ESRD have been shown to reduce mortality in a large randomized controlled trial without any significantly increased risk of hyperkalemia. Implantable Cardiac-defibrillators (ICDs) should be considered for primary prevention of sudden cardiac death in patients with HFrEF and ESRD who meet the implant indications. Furthermore in anemic iron-deficient patients, intravenous iron infusion may improve functional status. Finally, mechanical circulatory support with leftventricular assist devices may be related to increased mortality risk and the presence of ESRD poses a relative contraindication to further evaluation of these devices. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Implantable cardioverter-defibrillator lead failure in children and young adults: a matter of lead diameter or lead design?

PubMed

Janson, Christopher M; Patel, Akash R; Bonney, William J; Smoots, Karen; Shah, Maully J

2014-01-21

This study aimed to investigate the impact of lead diameter and design on implantable cardioverter-defibrillator (ICD) lead survival in children and young adults. Recent reports have called attention to high rates of lead failure in adults with small-diameter ICD leads, but data in the pediatric population is limited. We reviewed lead performance in consecutive subjects ≤30 years with transvenous right ventricular ICD leads implanted at our center between January 1995 and October 2011. Lead failure was defined as fracture, perforation, or sensing failure necessitating revision. A total of 120 ICD leads were implanted in 101 patients at a mean age of 15.5 ± 4.9 years. There were 47 small-diameter (≤8-F) and 73 standard-diameter (>8-F) leads. During a median follow-up of 28.7 months (interquartile range: 14.4 to 59.2 months), there were 25 lead failures (21% prevalence), with an incidence of 5.6%/year (95% confidence interval: 3.4 to 7.8). Sprint Fidelis (SF) (Medtronic, Inc., Minneapolis, Minnesota) leads had lower 3-year (69% vs. 92%, p < 0.01) and 5-year (44% vs. 86%, p < 0.01) survival probabilities than standard-diameter leads. In multivariate Cox regression, SF design conferred the greatest hazard ratio for lead failure (hazard ratio: 4.42, 95% confidence interval: 1.73 to 11.29, p < 0.01). Age and linear growth were not significantly associated with lead failure. In this single-center pediatric study that evaluated lead diameter, lead design, and patient factors, the SF design conferred the highest risk of lead failure, suggesting that design rather than diameter is the critical issue in ICD lead performance. Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Design of the effect of adaptive servo-ventilation on survival and cardiovascular hospital admissions in patients with heart failure and sleep apnoea: the ADVENT-HF trial.

PubMed

Lyons, Owen D; Floras, John S; Logan, Alexander G; Beanlands, Robert; Cantolla, Joaquin Durán; Fitzpatrick, Michael; Fleetham, John; John Kimoff, R; Leung, Richard S T; Lorenzi Filho, Geraldo; Mayer, Pierre; Mielniczuk, Lisa; Morrison, Debra L; Ryan, Clodagh M; Series, Frederic; Tomlinson, George A; Woo, Anna; Arzt, Michael; Parthasarathy, Sairam; Redolfi, Stefania; Kasai, Takatoshi; Parati, Gianfranco; Delgado, Diego H; Bradley, T Douglas

2017-04-01

Both types of sleep-disordered breathing (SDB), obstructive and central sleep apnoea (OSA and CSA, respectively), are common in patients with heart failure and reduced ejection fraction (HFrEF). In such patients, SDB is associated with increased cardiovascular morbidity and mortality but it remains uncertain whether treating SDB by adaptive servo-ventilation (ASV) in such patients reduces morbidity and mortality. ADVENT-HF is designed to assess the effects of treating SDB with ASV on morbidity and mortality in patients with HFrEF. ADVENT-HF is a multicentre, multinational, randomized, parallel-group, open-label trial with blinded assessment of endpoints of standard medical therapy for HFrEF alone vs. with the addition of ASV in patients with HFrEF and SDB. Patients with a history of HFrEF undergo echocardiography and polysomnography. Those with a left ventricular ejection fraction ≤45% and SDB (apnoea-hypopnoea index ≥15) are eligible. SDB is stratified into OSA with ≥50% of events obstructive or CSA with >50% of events central. Those with OSA must not have excessive daytime sleepiness (Epworth score of ≤10). Patients are then randomized to receive or not receive ASV. The primary outcome is the composite of all-cause mortality, cardiovascular hospital admissions, new-onset atrial fibrillation requiring anti-coagulation but not hospitalization, and delivery of an appropriate discharge from an implantable cardioverter-defibrillator not resulting in hospitalization during a maximum follow-up time of 5 years. The ADVENT-HF trial will help to determine whether treating SDB by ASV in patients with HFrEF improves morbidity and mortality. © 2017 The Authors. European Journal of Heart Failure © 2017 European Society of Cardiology.

"Not all breast implants are equal: a 13-year review of implant longevity and reasons for explantation".

PubMed

Van Slyke, Aaron C; Carr, Michael; Carr, Nicholas J

2018-06-04

Augmentation mammoplasty is the most common aesthetic procedure. Textured implants control implant position and have improved capsular contracture rates; however, the impact of texturing on longevity and clinical findings at explantation is unclear. All cases of explantation between January 2005 - April 2017 from an aesthetic practice were reviewed retrospectively. Patient demographics, implant characteristics, time-to-explantation, and clinical presentation and intraoperative findings at explantation were analyzed. 539 breast implants were explanted during the study period: 249 saline, 147 smooth gel, 123 Biocell, and 20 other nonaggressively textured breast implants. Average time from placement to explantation was 7.5 years, 5.6 years, 4.9 years, and 4.0 years for saline, other textured, smooth gel, and Biocell implants, respectively (p-value = 3.25e-08). The percentage of implants removed associated with implant performance failure was 50.3%, 57.5%, 75.0%, and 85.4% for smooth gel, saline, other textured, and Biocell implants, respectively (p-value = 7.25e-09). 21.1% of Biocell implants versus 1.5% of all other implants presented with pain (p-value = 2.71e-15). 45 Biocell implants had double capsules; this phenomenon was not observed with any other implant type (p-value = 5.85e-37). Seven Biocell implants had late seromas, compared to three late seromas with any other implant type (p-value = 0.0013). Here, we provide evidence that Biocell implants have the shortest time-to-explantation and the highest proportion of implants associated with implant performance failure. This information should complement the informed consent process when selecting an appropriate implant.

HeartMate II left ventricular assist system: from concept to first clinical use.

PubMed

Griffith, B P; Kormos, R L; Borovetz, H S; Litwak, K; Antaki, J F; Poirier, V L; Butler, K C

2001-03-01

The HeartMate II left ventricular assist device (LVAD) (ThermoCardiosystems, Inc, Woburn, MA) has evolved from 1991 when a partnership was struck between the McGowan Center of the University of Pittsburgh and Nimbus Company. Early iterations were conceptually based on axial-flow mini-pumps (Hemopump) and began with purge bearings. As the project developed, so did the understanding of new bearings, computational fluid design and flow visualization, and speed control algorithms. The acquisition of Nimbus by ThermoCardiosystems, Inc (TCI) sped developments of cannulas, controller, and power/monitor units. The system has been successfully tested in more than 40 calves since 1997 and the first human implant occurred in July 2000. Multicenter safety and feasibility trials are planned for Europe and soon thereafter a trial will be started in the United States to test 6-month survival in end-stage heart failure.

Insulation Failure of the Linox Defibrillator Lead: A Case Report and Retrospective Review of a Single Center Experience.

PubMed

Howe, Andrew J; McKeag, Nicholas A; Wilson, Carol M; Ashfield, Kyle P; Roberts, Michael J

2015-06-01

Implantable cardioverter defibrillator (ICD) lead insulation failure and conductor externalization have been increasingly reported. The 7.8F silicon-insulated Linox SD and Linox S ICD leads (Biotronik, Berlin, Germany) were released in 2006 and 2007, respectively, with an estimated 85,000 implantations worldwide. A 39-year-old female suffered an out-of-hospital ventricular fibrillation (VF) arrest with successful resuscitation. An ICD was implanted utilizing a single coil active fixation Linox(Smart) S lead (Biotronik, Berlin, Germany). A device-triggered alert approximately 3 years after implantation confirmed nonphysiological high rate sensing leading to VF detection. A chest X-ray showed an abnormality of the ICD lead and fluoroscopic screening confirmed conductor externalization proximal to the defibrillator coil. In view of the combined electrical and fluoroscopic abnormalities, urgent lead extraction and replacement were performed. A review of Linox (Biotronik) and Vigila (Sorin Group, Milan, Italy) lead implantations within our center (n = 98) identified 3 additional patients presenting with premature lead failure, 2 associated with nonphysiological sensed events and one associated with a significant decrease in lead impedance. All leads were subsequently removed and replaced. This case provides a striking example of insulation failure affecting the Linox ICD lead and, we believe, is the first to demonstrate conductor externalization manifesting both electrical and fluoroscopic abnormalities. © 2015 Wiley Periodicals, Inc.

Implantable Cardioverter Defibrillators for Primary Prevention of Mortality in Patients With Nonischemic Cardiomyopathy: A Meta-Analysis of Randomized Controlled Trials.

PubMed

Stavrakis, Stavros; Asad, Zain; Reynolds, Dwight

2017-06-01

Implantable cardioverter defibrillators (ICDs) improve survival in patients with heart failure due to ischemic cardiomyopathy, but their benefit in nonischemic cardiomyopathy (NICM) has been recently questioned. We performed a meta-analysis of randomized clinical trials to examine the effect of ICDs on total mortality and arrhythmic death in patients with NICM. We also examined the impact of age and cardiac resynchronization therapy (CRT) on the relative effect of ICD compared to control. We searched the MEDLINE and EMBASE databases for randomized trials evaluating the effect of ICD versus control in patients with NICM. Hazard ratios (HR) with 95% confidence interval (CI) were calculated using a random effects model. Six trials involving 2,967 patients were included (ICD, n = 1,553; control, n = 1,414). Based on the pooled estimate across the six studies, the use of ICD was associated with a significant reduction in total mortality (HR = 0.78, 95% CI 0.66-0.92; P = 0.003), as well as arrhythmic death (HR = 0.46, 95% CI 0.29-0.71; P = 0.0005) compared to control. ICD decreased total mortality in younger patients compared to control (HR = 0.63, 95% CI 0.46-0.86; P = 0.004), but not in older patients (HR = 0.97, 95% CI 0.56-1.68; P = 0.92). In patients with CRT, ICD reduced total mortality compared to control (HR = 0.78, 95% CI 0.65-0.95; P = 0.02), but not in patients with CRT (HR = 0.71, 95% CI 0.40-1.26). ICDs decrease total mortality and arrhythmic deaths in patients with NICM. The benefit of ICD appears to be dependent on age and concomitant use of CRT. © 2017 Wiley Periodicals, Inc.

Comparisons of Auditory Performance and Speech Intelligibility after Cochlear Implant Reimplantation in Mandarin-Speaking Users

PubMed Central

Hwang, Chung-Feng; Ko, Hui-Chen; Tsou, Yung-Ting; Chan, Kai-Chieh; Fang, Hsuan-Yeh; Wu, Che-Ming

2016-01-01

Objectives. We evaluated the causes, hearing, and speech performance before and after cochlear implant reimplantation in Mandarin-speaking users. Methods. In total, 589 patients who underwent cochlear implantation in our medical center between 1999 and 2014 were reviewed retrospectively. Data related to demographics, etiologies, implant-related information, complications, and hearing and speech performance were collected. Results. In total, 22 (3.74%) cases were found to have major complications. Infection (n = 12) and hard failure of the device (n = 8) were the most common major complications. Among them, 13 were reimplanted in our hospital. The mean scores of the Categorical Auditory Performance (CAP) and the Speech Intelligibility Rating (SIR) obtained before and after reimplantation were 5.5 versus 5.8 and 3.7 versus 4.3, respectively. The SIR score after reimplantation was significantly better than preoperation. Conclusions. Cochlear implantation is a safe procedure with low rates of postsurgical revisions and device failures. The Mandarin-speaking patients in this study who received reimplantation had restored auditory performance and speech intelligibility after surgery. Device soft failure was rare in our series, calling attention to Mandarin-speaking CI users requiring revision of their implants due to undesirable symptoms or decreasing performance of uncertain cause. PMID:27413753

Comparison of 3 biodegradable polymer and durable polymer-based drug-eluting stents in all-comers (BIO-RESORT): rationale and study design of the randomized TWENTE III multicenter trial.

PubMed

Lam, Ming Kai; Sen, Hanim; Tandjung, Kenneth; van Houwelingen, K Gert; de Vries, Arie G; Danse, Peter W; Schotborgh, Carl E; Scholte, Martijn; Löwik, Marije M; Linssen, Gerard C M; Ijzerman, Maarten J; van der Palen, Job; Doggen, Carine J M; von Birgelen, Clemens

2014-04-01

To evaluate the safety and efficacy of 2 novel drug-eluting stents (DES) with biodegradable polymer-based coatings versus a durable coating DES. BIO-RESORT is an investigator-initiated, prospective, patient-blinded, randomized multicenter trial in 3540 Dutch all-comers with various clinical syndromes, requiring percutaneous coronary interventions (PCI) with DES implantation. Randomization (stratified for diabetes mellitus) is being performed in a 1:1:1 ratio between ORSIRO sirolimus-eluting stent with circumferential biodegradable coating, SYNERGY everolimus-eluting stent with abluminal biodegradable coating, and RESOLUTE INTEGRITY zotarolimus-eluting stent with durable coating. The primary endpoint is the incidence of the composite endpoint target vessel failure at 1 year, consisting of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. Power calculation assumes a target vessel failure rate of 8.5% with a 3.5% non-inferiority margin, giving the study a power of 85% (α level .025 adjusted for multiple testing). The impact of diabetes mellitus on post-PCI outcome will be evaluated. The first patient was enrolled on December 21, 2012. BIO-RESORT is a large, prospective, randomized, multicenter trial with three arms, comparing two DES with biodegradable coatings versus a reference DES with a durable coating in 3540 all-comers. The trial will provide novel insights into the clinical outcome of modern DES and will address the impact of known and so far undetected diabetes mellitus on post-PCI outcome. Copyright © 2014 The Authors. Published by Mosby, Inc. All rights reserved.

Experience in cochlear reimplantation. Descriptive study of a 20-year period.

PubMed

Gutiérrez-Salazar, Andrés; Cop, Constanze; Osorio-Acosta, Ángel; Borkoski-Barreiro, Silvia; Falcón-González, Juan C; Ramos-Macías, Ángel

2015-01-01

The cochlear implant is a surgical procedure that has increased substantially, because the paediatric population is diagnosed and implanted early and because there are increased potential indications. This device has the inherent risk of failure in performance, as dies any active medical device, which is the most common cause of implant removal. Our goal was to understand what the causes that produced removal in our series were, and confirm if these conformed to reality as reviewed in the literature. This was a retrospective, descriptive, observational study of 859 cochlear implant surgeries carried out between October 1991 and May 2011. The causes of implant removal were classified according to the European Consensus Statement on Cochlear Implant Failures and Explantations. The reimplantation rate was 6.16% (n=51). The most common reason for removal was technical device failure (45.5%), followed by infection/rejection (23.6%) and upgrade (12.7%). Less common causes: there were 3 cases (5.6%) of electrode misplacement, 2 cases (3.6%) of labyrinthine ossification, 2 (3.6%) as a result of head trauma, 2 (3.6%) from need for nuclear magnetic resonance imaging and 1 case (1.8%) from psychiatric illness. Cochlear reimplantation is a safe procedure, with a low complication rate. In our centre, it reaches an overall rate of 6.16%. Technical device failure remains the most common cause of this procedure, although there is a significant percentage of reimplantation for device update. Copyright © 2014 Elsevier España, S.L.U. and Sociedad Española de Otorrinolaringología y Patología Cérvico-Facial. All rights reserved.

Marginal Bone Remodeling around healing Abutment vs Final Abutment Placement at Second Stage Implant Surgery: A 12-month Randomized Clinical Trial.

PubMed

Nader, Nabih; Aboulhosn, Maissa; Berberi, Antoine; Manal, Cordahi; Younes, Ronald

2016-01-01

The periimplant bone level has been used as one of the criteria to assess the success of dental implants. It has been documented that the bone supporting two-piece implants undergoes resorption first following the second-stage surgery and later on further to abutment connection and delivery of the final prosthesis. The aim of this multicentric randomized clinical trial was to evaluate the crestal bone resorption around internal connection dental implants using a new surgical protocol that aims to respect the biological distance, relying on the benefit of a friction fit connection abutment (test group) compared with implants receiving conventional healing abutments at second-stage surgery (control group). A total of partially edentulous patients were consecutively treated at two private clinics, with two adjacent two-stage implants. Three months after the first surgery, one of the implants was randomly allocated to the control group and was uncovered using a healing abutment, while the other implant received a standard final abutment and was seated and tightened to 30 Ncm. At each step of the prosthetic try-in, the abutment in the test group was removed and then retightened to 30 Ncm. Horizontal bone changes were assessed using periapical radiographs immediately after implant placement and at 3 (second-stage surgery), 6, 9 and 12 months follow-up examinations. At 12 months follow-up, no implant failure was reported in both groups. In the control group, the mean periimplant bone resorption was 0.249 ± 0.362 at M3, 0.773 ± 0.413 at M6, 0.904 ± 0.36 at M9 and 1.047 ± 0.395 at M12. The test group revealed a statistically significant lower marginal bone loss of 20.88% at M3 (0.197 ± 0.262), 22.25% at M6 (0.601 ± 0.386), 24.23% at M9 (0.685 ± 0.341) and 19.2% at M9 (0.846 ± 0.454). The results revealed that bone loss increased over time, with the greatest change in bone loss occurring between 3 and 6 months. Alveolar bone loss was significantly greater in the control condition than the test condition. The results of this prospective study demonstrated the benefit of placing a prosthetic component with a stable connection at second-stage surgery, in terms of reduced marginal bone remodeling when compared with conventional procedure. The use of a stable connection in a healing component during try-in stages prior to final restoration placement leads to less periimplant marginal bone loss.

Comparison of Sprint Fidelis and Riata defibrillator lead failure rates.

PubMed

Fazal, Iftikhar A; Shepherd, Ewen J; Tynan, Margaret; Plummer, Christopher J; McComb, Janet M

2013-09-30

Sprint Fidelis and Riata defibrillator leads are prone to early failure. Few data exist on the comparative failure rates and mortality related to lead failure. The aims of this study were to determine the failure rate of Sprint Fidelis and Riata leads, and to compare failure rates and mortality rates in both groups. Patients implanted with Sprint Fidelis leads and Riata leads at a single centre were identified and in July 2012, records were reviewed to ascertain lead failures, deaths, and relationship to device/lead problems. 113 patients had Sprint Fidelis leads implanted between June 2005 and September 2007; Riata leads were implanted in 106 patients between January 2003 and February 2008. During 53.0 ± 22.3 months of follow-up there were 13 Sprint Fidelis lead failures (11.5%, 2.60% per year) and 25 deaths. Mean time to failure was 45.1 ± 15.5 months. In the Riata lead cohort there were 32 deaths, and 13 lead failures (11.3%, 2.71% per year) over 54.8 ± 26.3 months follow-up with a mean time to failure of 53.5 ± 24.5 months. There were no significant differences in the lead failure-free Kaplan-Meier survival curve (p=0.77), deaths overall (p=0.17), or deaths categorised as sudden/cause unknown (p=0.54). Sprint Fidelis and Riata leads have a significant but comparable failure rate at 2.60% per year and 2.71% per year of follow-up respectively. The number of deaths in both groups is similar and no deaths have been identified as being related to lead failure in either cohort. Copyright © 2012. Published by Elsevier Ireland Ltd.

Interventional Treatment of Severe Tricuspid Regurgitation: Early Clinical Experience in a Multicenter, Observational, First-in-Man Study.

PubMed

Lauten, Alexander; Figulla, Hans R; Unbehaun, Axel; Fam, Neil; Schofer, Joachim; Doenst, Torsten; Hausleiter, Joerg; Franz, Marcus; Jung, Christian; Dreger, Henryk; Leistner, David; Alushi, Brunilda; Stundl, Anja; Landmesser, Ulf; Falk, Volkmar; Stangl, Karl; Laule, Michael

2018-02-01

Transcatheter caval valve implantation is under evaluation as a treatment option for inoperable patients with severe tricuspid regurgitation (TR). The procedure involves the catheter-based implantation of bioprosthetic valves in the inferior vena cava and superior vena cava to treat symptoms associated with TR. This study is the first to evaluate the feasibility, safety, and efficacy of this interventional concept. Twenty-five patients (mean age, 73.9±7.6 years; women, 52.0%) with severe symptomatic TR despite optimal medical treatment deemed unsuitable for surgery were treated with caval valve implantation under a compassionate clinical use program. Technical feasibility defined as procedural success, hemodynamic effect defined as venous pressure reduction, and safety defined as periprocedural adverse events were evaluated, with clinical follow-up at discharge and up to 12 months. The functional impact was evaluated by assessment of New York Heart Association class at the time of hospital discharge. The total number of valves implanted in the caval position was 31. Patients were treated with single (inferior vena cava-only; n=19; 76.0%) or bicaval valve implantation (inferior vena cava+superior vena cava; n=6; 24.0%). Either balloon-expandable valves (Sapien XT/3: n=18; 72.0%) or self-expandable valves (TricValve: n=6; 24.0%; Directflow: n=1; 4.0%) were used. Procedural success was achieved in 96% (n=24). Early and late valve migration requiring surgical intervention occurred in 1 patient each. Thirty-day and in-hospital mortality were 8% (2 of 25) and 16% (4 of 25). Causes of in-hospital mortality included respiratory (n=1) or multiple organ failure (n=3) and were not linked to the procedure. Mean overall survival in the study cohort was 316±453 days (14-1540 days). Caval valve implantation for the treatment of severe TR and advanced right ventricular failure is associated with a high procedural success rate and seems safe and feasible in an excessive-risk cohort. The study demonstrates hemodynamic efficacy with consistent elimination of TR-associated venous backflow and initial clinical improvement. These results encourage further trials to determine which patients benefit most from this interventional approach. © 2018 American Heart Association, Inc.

Long-term outcomes of dental implants placed in elderly patients: a retrospective clinical and radiographic analysis.

PubMed

Park, Jung-Chul; Baek, Won-Sun; Choi, Seong-Ho; Cho, Kyoo-Sung; Jung, Ui-Won

2017-02-01

The aim of this retrospective study was to determine the clinical and the radiographic outcomes of dental implants placed in elderly people older than 65 years. In total, 902 implants in 346 patients (age: 65-89 years) were followed up for 2-17 years following the implant surgery. The survival rate of these implants was recorded and analyzed. Changes in marginal bone levels were also analyzed in serial radiographs, and Cox regression analysis for implant loss was performed. The survival rates were 95.39% and 99.98% in the implant- and patient-based analyses, respectively (involving a total of 29 implant failures), and the marginal bone loss at the implants was 0.17 ± 0.71 mm (mean ± SD). The number of failures was greatest in patients aged 65-69 years. The Cox regression with shared frailty analysis showed that implant loss was significantly greater in those aged 65-69 years than in those aged 70-74 years (P < 0.05), and it varied between specific implant systems. Within the limitations of this retrospective study, it was concluded that implant therapy can be successfully provided to elderly patients and that age alone does not seem to affect the implant survival rate. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Role of long-term mechanical circulatory support in patients with advanced heart failure.

PubMed

Stokes, M B; Bergin, P; McGiffin, D

2016-05-01

Advanced heart failure represents a small proportion of patients with heart failure that possess high-risk features associated with high hospital readmission rates, significant functional impairment and mortality. Identification of those who have progressed to, or are near a state of advanced heart failure should prompt referral to a service that offers therapies in mechanical circulatory support (MCS) and cardiac transplantation. MCS has grown as a management strategy in the care of these patients, most commonly as a bridge to cardiac transplantation. The predominant utilisation of MCS is implantation of left ventricular assist devices (LVAD), which have evolved significantly in their technology and application over the past 15-20 years. The technology has evolved to such an extent that Destination Therapy is now being utilised as a strategy in management of advanced heart failure in appropriately selected patients. Complication rates have decreased with VAD implantation, but remain a significant consideration in the decision to implant a device, and in the follow up of these patients. © 2016 Royal Australasian College of Physicians.

Integrated versus non-integrated orbital implants for treating anophthalmic sockets.

PubMed

Schellini, Silvana; El Dib, Regina; Silva, Leandro Re; Farat, Joyce G; Zhang, Yuqing; Jorge, Eliane C

2016-11-07

Anophthalmia is the absence of one or both eyes, and it can be congenital (i.e. a birth defect) or acquired later in life. There are two main types of orbital implant: integrated, whereby the implant receives a blood supply from the body that allows for the integration of the prosthesis within the tissue; and non-integrated, where the implant remains separate. Despite the remarkable progress in anophthalmic socket reconstruction and in the development of various types of implants, there are still uncertainties about the real roles of integrated (hydroxyapatite (HA), porous polyethylene (PP), composites) and non-integrated (polymethylmethacrylate (PMMA)/acrylic and silicone) orbital implants in anophthalmic socket treatment. To assess the effects of integrated versus non-integrated orbital implants for treating anophthalmic sockets. We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 7), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to August 2016), Embase (January 1980 to August 2016), Latin American and Caribbean Health Sciences Literature Database (LILACS) (1982 to August 2016), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov), and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 8 August 2016. Randomised controlled trials (RCTs) and quasi-RCTs of integrated and non-integrated orbital implants for treating anophthalmic sockets. Two authors independently selected relevant trials, assessed methodological quality and extracted data. We included three studies with a total of 284 participants (250 included in analysis). The studies were conducted in India, Iran and the Netherlands. The three studies were clinically heterogenous, comparing different materials and using different surgical techniques. None of the included studies used a peg (i.e. a fixing pin used to connect the implant to the prosthesis). In general the trials were poorly reported, and we judged them to be at unclear risk of bias.One trial compared HA using traditional enucleation versus alloplastic implantation using evisceration (N = 100). This trial was probably not masked. The second trial compared PP with scleral cap enucleation versus PMMA with either myoconjunctival or traditional enucleation (N = 150). Although participants were not masked, outcome assessors were. The last trial compared HA and acrylic using the enucleation technique (N = 34) but did not report comparative effectiveness data.In the trial comparing HA versus alloplastic implantation, there was no evidence of any difference between the two groups with respect to the proportion of successful procedures at one year (risk ratio (RR) 1.02, 95% confidence interval (CI) 0.95 to 1.09, N = 100, low-certainty evidence). People receiving HA had slightly worse horizontal implant mobility compared to the alloplastic group (mean difference (MD) -3.35 mm, 95% CI -4.08 to -2.62, very low-certainty evidence) and slightly worse vertical implant motility (MD -2.76 mm, 95% CI -3.45 to -2.07, very low-certainty evidence). As different techniques were used - enucleation versus evisceration - it is not clear whether these differences in implant motility can be attributed solely to the type of material. Investigators did not report adverse events.In the trial comparing PP versus PMMA, there was no evidence of any difference between the two groups with respect to the proportion of successful procedures at one year (RR 0.92, 95% CI 0.84 to 1.01, N = 150, low-certainty evidence). There was very low-certainty evidence of a difference in horizontal implant motility depending on whether PP was compared to PMMA with traditional enucleation (MD 1.96 mm, 95% CI 1.01 to 2.91) or PMMA with myoconjunctival enucleation (-0.57 mm, 95% CI -1.63 to 0.49). Similarly, for vertical implant motility, there was very low-certainty evidence of a difference in the comparison of PP to PMMA traditional (MD 3.12 mm 95% CI 2.36 to 3.88) but no evidence of a difference when comparing PP to PMMA myoconjunctival (MD -0.20 mm 95% CI -1.28 to 0.88). Four people in the PP group (total N = 50) experienced adverse events (i.e. exposures) compared to 6/100 in the PMMA groups (RR 17.82, 95% CI 0.98 to 324.67, N = 150, very low-certainty evidence).None of the studies reported socket sphere size, cosmetic effect or quality of life measures. Current very low-certainty evidence from three small published randomised controlled trials did not provide sufficient evidence to assess the effect of integrated and non-integrated material orbital implants for treating anophthalmic sockets. This review underlines the need to conduct further well-designed trials in this field.

Enhancement of the fatigue performance of Ti-6Al-4V implant products

NASA Astrophysics Data System (ADS)

Wimalasiri, Dematapaksha H. R. J.

Implants surgery, in particular hip implants, is fast becoming a routine, popular approach for curing diseases such as, osteoarthritis and rheumatic arthritis. However one potential problem with the insertion of a metal implant is that of the risk of fatigue failure. Numerous factors affect the propensity of a metal to fatigue, none more so than the physical and stress state of the surface. This research is focused on an assessment of the role of manufacturing processes on the fatigue performance of hip implants made from a Ti-6Al-4V alloy. The role of surface defects, surface residual stresses and material microstructural properties which influence fatigue performance were examined. Characterization of the implant material and of the processes involved in actual hip implant manufacturing were conducted. Rotating bend fatigue testing using hour glass shaped specimens was conducted to evaluate the fatigue performance at selected manufacturing stages. The surface roughness/defects and residual stresses were measured prior to conducting fatigue tests. A variation of fatigue limit, attributed to variations of surface roughness and surface residual stress was observed. The influence of parameters such as, stress ratio and mean stress effect, variation of fracture mechanics parameters (e.g. DeltaK[th]) and the limiting threshold conditions for different stages of cracks were investigated in the context of Kitagawa-Takahashi (K-T) type diagrams. Experimental data was used to develop models which were used to calculate, (i). fatigue life at respective stress amplitude and, (ii). the fatigue limit of components with known surface roughness/defect size and residual stress. To evaluate material crack growth properties a surface replication method was used. The output from both models showed good correlation with experimental data. Comprehensive fractography was conducted using optical, secondary electron, and infinite focus microscopy to support the results obtained from fatigue testing. Analysis was performed on in-vivo hip implant failure data covering the last 12 years. Fatigue failures occur in two locations on the implant stem, namely the cone area and the neck area. These two locations were investigated separately to identify the factors, such as; the category of implant most vulnerable to failure, service life, design features, fixation with the host bone, crack initiation features and propagation details. An attempt was made to compare in-vivo fatigue features with experimental fatigue results. X-ray diffraction (XRD) was used to investigate the surface residual stresses resulting from different manufacturing processes. The results were confirmed and software and hardware settings were calibrated in accordance with the results obtained from XRD analysis conducted at National Physical Laboratories (NPL), UK. Surface roughness measurements were also conducted using stylus type surface profilometer. The knowledge gained from this research can be used to understand the causes and modes of in-vivo fatigue failure of hip implants made of Ti-6Al-4V. Understanding the fatigue/mechanical properties of the implant material enables recommendations and optimization of good practice in manufacturing to eliminate in-vivo fatigue failures.

Ethical challenges with the left ventricular assist device as a destination therapy

PubMed Central

Rizzieri, Aaron G; Verheijde, Joseph L; Rady, Mohamed Y; McGregor, Joan L

2008-01-01

The left ventricular assist device was originally designed to be surgically implanted as a bridge to transplantation for patients with chronic end-stage heart failure. On the basis of the REMATCH trial, the US Food and Drug Administration and the US Centers for Medicare & Medicaid Services approved permanent implantation of the left ventricular assist device as a destination therapy in Medicare beneficiaries who are not candidates for heart transplantation. The use of the left ventricular assist device as a destination therapy raises certain ethical challenges. Left ventricular assist devices can prolong the survival of average recipients compared with optimal medical management of chronic end-stage heart failure. However, the overall quality of life can be adversely affected in some recipients because of serious infections, neurologic complications, and device malfunction. Left ventricular assist devices alter end-of-life trajectories. The caregivers of recipients may experience significant burden (e.g., poor physical health, depression, anxiety, and posttraumatic stress disorder) from destination therapy with left ventricular assist devices. There are also social and financial ramifications for recipients and their families. We advocate early utilization of a palliative care approach and outline prerequisite conditions so that consenting for the use of a left ventricular assist device as a destination therapy is a well informed process. These conditions include: (1) direct participation of a multidisciplinary care team, including palliative care specialists, (2) a concise plan of care for anticipated device-related complications, (3) careful surveillance and counseling for caregiver burden, (4) advance-care planning for anticipated end-of-life trajectories and timing of device deactivation, and (5) a plan to address the long-term financial burden on patients, families, and caregivers. Short-term mechanical circulatory devices (e.g. percutaneous cardiopulmonary bypass, percutaneous ventricular assist devices, etc.) can be initiated in emergency situations as a bridge to permanent implantation of ventricular assist devices in chronic end-stage heart failure. In the absence of first-person (patient) consent, presumed consent or surrogate consent should be used cautiously for the initiation of short-term mechanical circulatory devices in emergency situations as a bridge to permanent implantation of left ventricular assist devices. Future clinical studies of destination therapy with left ventricular assist devices should include measures of recipients' quality of end-of-life care and caregivers' burden. PMID:18694496

Phacoemulsification combined with a new ab interno gel stent to treat open-angle glaucoma: Pilot study.

PubMed

Sheybani, Arsham; Lenzhofer, Markus; Hohensinn, Melchior; Reitsamer, Herbert; Ahmed, Iqbal Ike K

2015-09-01

To study the effect on intraocular pressure (IOP) of implanting a new gelatin stent at the time of cataract surgery in the treatment of open-angle glaucoma (OAG). Multicenter university and private-practice settings. Nonrandomized prospective clinical trial. The implantation of 2 models of a gelatin stent (Xen140 and Xen63) was performed at the time of cataract surgery without mitomycin-C. Complete success was defined as a postoperative IOP of less than 18 mm Hg and more than a 20% reduction in IOP at 12 months without glaucoma medication. Failure was defined as loss of light perception vision or worse, a need for additional glaucoma surgery, or less than a 20% reduction in the IOP from baseline. The study included 37 eyes of 37 patients. The mean preoperative IOP was 22.4 mm Hg ± 4.2 (SD) on 2.5 ± 1.4 medication classes. Twelve months postoperatively, the mean IOP was reduced to 15.4 ± 3.0 mm Hg on 0.9 ± 1.0 medication classes (P < .0001). This resulted in a qualified success of 85.3% and a complete success rate off medications of 47.1%. There were no failures. Cataract surgery combined with implantation of the gelatin stent resulted in a significant reduction in IOP in eyes with OAG. Dr. Sheybani has received travel reimbursement from Aquesys, Inc. Dr. Ahmed is a paid consultant to Aquesys, Inc. No other author has a financial or proprietary interest in any material or method mentioned. Copyright © 2015 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

Adherence to 2016 European Society of Cardiology guidelines predicts outcome in a large real-world population of heart failure patients requiring cardiac resynchronization therapy.

PubMed

Stabile, Giuseppe; Pepi, Patrizia; Palmisano, Pietro; D'Onofrio, Antonio; De Simone, Antonio; Caico, Salvatore Ivan; Pecora, Domenico; Rapacciuolo, Antonio; Arena, Giuseppe; Marini, Massimiliano; Pieragnoli, Paolo; Badolati, Sandra; Savarese, Gianluca; Maglia, Gianpiero; Iuliano, Assunta; Botto, Giovanni Luca; Malacrida, Maurizio; Bertaglia, Emanuele

2018-04-14

Professional guidelines are based on the best available evidence. However, patients treated in clinical practice may differ from those included in reference trials. The aim of this study was to evaluate the effects of cardiac resynchronization therapy (CRT) in a large population of patients implanted with a CRT device stratified in accordance with the 2016 European heart failure (HF) guidelines. We collected data on 930 consecutive patients from the Cardiac Resynchronization Therapy MOdular REgistry. The primary end point was a composite of death and HF hospitalization. Five hundred sixty-three (60.5%) patients met class I indications, 145 (15.6%) class IIa, 108 (11.6%) class IIb, and 114 (12.3%) class III. After a median follow-up of 1001 days, 120 patients who had an indication for CRT implantation had died and 71 had been hospitalized for HF. The time to the end point was longer in patients with a class I indication (hazard ratio 0.55; 95% confidence interval 0.39-0.76; P = .0001). After 12 months, left ventricular (LV) end-systolic volume had decreased by ≥15% in 61.5% of patients whereas in 57.5% of patients the absolute LV ejection fraction improvement was ≥5%. Adherence to class I was also associated with an absolute LV ejection fraction increase of >5% (P = .0142) and an LV end-systolic volume decrease of ≥15% (P = .0055). In our population, ∼60% of patients underwent implantation according to the 2016 European HF guidelines class I indication. Adherence to class I was associated with a lower death and HF hospitalization rate and better LV reverse remodeling. Copyright © 2018 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Comparative assessment of implantable hip devices with different bearing surfaces: systematic appraisal of evidence.

PubMed

Sedrakyan, Art; Normand, Sharon-Lise T; Dabic, Stefan; Jacobs, Samantha; Graves, Stephen; Marinac-Dabic, Danica

2011-11-29

To determine comparative safety and effectiveness of combinations of bearing surfaces of hip implants. Systematic review of clinical trials, observational studies, and registries. Medline, Embase, Cochrane Controlled Trials Register, reference lists of articles, annual reports of major registries, summaries of safety and effectiveness for pre-market application and mandated post-market studies at the United States Food and Drug Administration. Criteria for inclusion were comparative studies in adults reporting information for various combinations of bearings (such as metal on metal and ceramic on ceramic). Data search, abstraction, and analyses were independently performed and confirmed by at least two authors. Qualitative data syntheses were performed. There were 3139 patients and 3404 hips enrolled in 18 comparative studies and over 830 000 operations in national registries. The mean age range in the trials was 42-71, and 26-88% were women. Disease specific functional outcomes and general quality of life scores were no different or they favoured patients receiving metal on polyethylene rather than metal on metal in the trials. While one clinical study reported fewer dislocations associated with metal on metal implants, in the three largest national registries there was evidence of higher rates of implant revision associated with metal on metal implants compared with metal on polyethylene. One trial reported fewer revisions with ceramic on ceramic compared with metal on polyethylene implants, but data from national registries did not support this finding. There is limited evidence regarding comparative effectiveness of various hip implant bearings. Results do not indicate any advantage for metal on metal or ceramic on ceramic implants compared with traditional metal on polyethylene or ceramic on polyethylene bearings.

Early diagnosis of orthopedic implant failure using macromolecular imaging agents.

PubMed

Ren, Ke; Dusad, Anand; Zhang, Yijia; Purdue, P Edward; Fehringer, Edward V; Garvin, Kevin L; Goldring, Steven R; Wang, Dong

2014-08-01

To develop and evaluate diagnostic tools for early detection of wear particle-induced orthopaedic implant loosening. N-(2-Hydroxypropyl)methacrylamide (HPMA) copolymer was tagged with a near infrared dye and used to detect the inflammation induced by polymethylmethacrylate (PMMA) particles in a murine peri-implant osteolysis model. It was established by inserting an implant into the distal femur and challenging with routine PMMA particles infusion. The osteolysis was evaluated by micro-CT and histological analysis at different time points. Significant peri-implant osteolysis was found 3-month post PMMA particle challenge by micro-CT and histological analysis. At 1-month post challenge, when there was no significant peri-implant bone loss, the HPMA copolymer-near infrared dye conjugate was found to specifically target the femur with PMMA particles deposition, but not the contralateral control femur with phosphate buffered saline (PBS) infusion. The results from this study demonstrate the feasibility of utilizing the macromolecular diagnostic agent to detect particle-induced peri-implant inflammation prior to the development of detectable osteolysis. Recognition of this early pathological event would provide the window of opportunity for prevention of peri-implant osteolysis and subsequent orthopaedic implant failure.

Fatigue Failure of External Hexagon Connections on Cemented Implant-Supported Crowns.

PubMed

Malta Barbosa, João; Navarro da Rocha, Daniel; Hirata, Ronaldo; Freitas, Gileade; Bonfante, Estevam A; Coelho, Paulo G

2018-01-17

To evaluate the probability of survival and failure modes of different external hexagon connection systems restored with anterior cement-retained single-unit crowns. The postulated null hypothesis was that there would be no differences under accelerated life testing. Fifty-four external hexagon dental implants (∼4 mm diameter) were used for single cement-retained crown replacement and divided into 3 groups: (3i) Full OSSEOTITE, Biomet 3i (n = 18); (OL) OEX P4, Osseolife Implants (n = 18); and (IL) Unihex, Intra-Lock International (n = 18). Abutments were torqued to the implants, and maxillary central incisor crowns were cemented and subjected to step-stress-accelerated life testing in water. Use-level probability Weibull curves and probability of survival for a mission of 100,000 cycles at 200 N (95% 2-sided confidence intervals) were calculated. Stereo and scanning electron microscopes were used for failure inspection. The beta values for 3i, OL, and IL (1.60, 1.69, and 1.23, respectively) indicated that fatigue accelerated the failure of the 3 groups. Reliability for the 3i and OL (41% and 68%, respectively) was not different between each other, but both were significantly lower than IL group (98%). Abutment screw fracture was the failure mode consistently observed in all groups. Because the reliability was significantly different between the 3 groups, our postulated null hypothesis was rejected.

Survival of Dental Implants Placed in Grafted and Nongrafted Bone: A Retrospective Study in a University Setting.

PubMed

Tran, Duong T; Gay, Isabel C; Diaz-Rodriguez, Janice; Parthasarathy, Kavitha; Weltman, Robin; Friedman, Lawrence

2016-01-01

To compare dental implant survival rates when placed in native bone and grafted sites. Additionally, risk factors associated with dental implant loss were identified. This study was based on the hypothesis that bone grafting has no effect on implant survival rates. A retrospective chart review was conducted for patients receiving dental implants at the University of Texas, School of Dentistry from 1985 to 2012. Exclusion criteria included patients with genetic diseases, radiation and chemotherapy, or an age less than 18 years. To avoid misclassification bias, implants were excluded if bone grafts were only done at the same time of placement. Data on age, sex, tobacco use, diabetes, osteoporosis, anatomical location of the implant, implant length and width, bone graft, and professional maintenance were collected for analysis. A total of 1,222 patients with 2,729 implants were included. The cumulative survival rates at 5 and 10 years were 92% and 87% for implants placed in native bone and 90% and 79% for implants placed in grafted bone, respectively. The results from multivariate analysis (Cox regression) indicated no significant difference in survival between the two groups; having maintenance therapy after implant placement reduced the failure rate by 80% (P < .001), and using tobacco increased the failure rate by 2.6-fold (P = .001). There was no difference in the dental implant survival rate when implants were placed in native bone or bone-grafted sites. Smoking and lack of professional maintenance were significantly related to increased implant loss.

Diode Laser and Periodontal Regeneration-Assisted Management of Implant Complications in Anterior Maxilla.

PubMed

Salaria, Sanjeev Kumar; Sharma, Isha; Brar, Navjot Kaur; Kaur, Satwant

2018-01-01

Dental implant is being considered successful if the patient is pleased with both of its functional and esthetic outcome. As implant complications (such as peri-implantitis, inappropriate implant position, wrong angulation, and implant location too close to anatomical structures) have been frequently encountered in dental practice, therefore, thorough knowledge to manage such complications is the key prerequisite to prevent the failure of implant. The present case report discussed the etiology, diagnosis of early peri-implantitis, and periodontal abscess with their successful management through periodontal regeneration and diode laser-assisted therapy.

Effect of intrauterine injection of human chorionic gonadotropin before embryo transfer on clinical pregnancy rates from in vitro fertilisation cycles: a prospective study.

PubMed

Santibañez, Alvaro; García, Jorge; Pashkova, Olga; Colín, Omar; Castellanos, Guillermo; Sánchez, Ana P; De la Jara, Julio F

2014-01-29

The implantation process after embryo transfer depends on the embryo quality and endometrial receptivity. It is estimated that fifty to seventy-five per cent of pregnancies are lost due to a failure of implantation. There is evidence that there is an early secretion of human chorionic gonadotrophin before embryo implantation, and this secretion has been linked to an important function in angiogenesis and the inflammatory response that promotes the implantation process. Our objective was to determine the effects of intrauterine injection of human chorionic gonadotropin (hCG) before the embryo transfer in an in vitro fertilisation cycle. A prospective randomised study was conducted in Reproductive Medicine Centre PROCREA in Mexico City. Infertile patients who had a medical indication for in vitro fertilisation were studied. Two groups were included (n 210); the intervention group received an intrauterine injection of 500 IU of hCG before the embryo transfer (n 101). The control group (n 109) did not receive hCG. Comparisons were performed using a chi-square test. The clinical pregnancy rate (CPR) was our principal outcome. The implantation rate was a secondary outcome. The implantation rate was significantly higher in the hCG group compared to the control group (52.4% vs 35.7%, p 0.014). The clinical pregnancy rate was also significantly higher (50.4 vs 33.0%, p 0.010). No adverse effects were observed. The intrauterine injection of hCG before embryo transfer showed a significant increase in the clinical pregnancy rate. More clinical trials are needed to reproduce these results on this promising intervention. The live birth rate must be included in subsequent studies.

Stratification of the Risk of Sudden Death in Nonischemic Heart Failure

PubMed Central

Pimentel, Maurício; Zimerman, Leandro Ioschpe; Rohde, Luis Eduardo

2014-01-01

Despite significant therapeutic advancements, heart failure remains a highly prevalent clinical condition associated with significant morbidity and mortality. In 30%-40% patients, the etiology of heart failure is nonischemic. The implantable cardioverter-defibrillator (ICD) is capable of preventing sudden death and decreasing total mortality in patients with nonischemic heart failure. However, a significant number of patients receiving ICD do not receive any kind of therapy during follow-up. Moreover, considering the situation in Brazil and several other countries, ICD cannot be implanted in all patients with nonischemic heart failure. Therefore, there is an urgent need to identify patients at an increased risk of sudden death because these would benefit more than patients at a lower risk, despite the presence of heart failure in both risk groups. In this study, the authors review the primary available methods for the stratification of the risk of sudden death in patients with nonischemic heart failure. PMID:25352509

Do Bone Graft and Cracking of the Sclerotic Cavity Improve Fixation of Titanium and Hydroxyapatite-coated Revision Implants in an Animal Model?

PubMed

Elmengaard, Brian; Baas, Joergen; Jakobsen, Thomas; Kold, Soren; Jensen, Thomas B; Bechtold, Joan E; Soballe, Kjeld

2017-02-01

We previously introduced a manual surgical technique that makes small perforations (cracks) through the sclerotic bone shell that typically forms during the process of aseptic loosening ("crack" revision technique). Perforating just the shell (without violating the proximal cortex) can maintain overall bone continuity while allowing marrow and vascular elements to access the implant surface. Because many revisions require bone graft to fill defects, we wanted to determine if bone graft could further increase implant fixation beyond what we have experimentally shown with the crack technique alone. Also, because both titanium (Ti6Al4V) and hydroxyapatite (HA) implant surfaces are used in revisions, we also wanted to determine their relative effectiveness in this model. We hypothesized that both (1) allografted plasma-sprayed Ti6Al4V; and (2) allografted plasma-sprayed HA-coated implants inserted with a crack revision technique have better fixation compared with a noncrack revision technique in each case. Under approval from our Institutional Animal Care and Use Committee, a female canine animal model was used to evaluate the uncemented revision technique (crack, noncrack) using paired contralateral implants while implant surface (Ti6Al4V, HA) was qualitatively compared between the two (unpaired) series. All groups received bone allograft tightly packed around the implant. This revision model includes a cylindrical implant pistoning 500 μm in a 0.75-mm gap, with polyethylene particles, for 8 weeks. This engenders a bone and tissue response representative of the metaphyseal cancellous region of an aseptically loosened component. At 8 weeks, the original implants were revised and followed for an additional 4 weeks. Mechanical fixation was assessed by load, stiffness, and energy to failure when loaded in axial pushout. Histomorphometry was used to determine the amount and location of bone and fibrous tissue in the grafted gap. The grafted crack revision improved mechanical shear strength, stiffness, and energy to failure (for Ti6Al4V 27- to 69-fold increase and HA twofold increases). The histomorphometric analysis demonstrated primarily fibrous membrane ongrowth and in the gap for the allografted Ti6Al4V noncrack revisions. For allografted HA noncrack revisions, bone ongrowth at the implant surface was observed, but fibrous tissue also was present in the inner gap. Although both Ti6Al4V and HA surfaces showed improved fixation with grafted crack revision, and Ti6Al4V achieved the highest percent gain, HA demonstrated the strongest overall fixation. The results of this study suggest that novel osteoconductive or osteoinductive coatings and bone graft substitutes or tissue-engineered constructs may further improve bone-implant fixation with the crack revision technique but require evaluation in a rigorous model such as presented here. This experimental study provides data on which to base clinical trials aimed to improve fixation of revision implants. Given the multifactorial nature of complex human revisions, such a protocoled clinical study is required to determine the clinical applicability of this approach.

Is bruxism a risk factor for dental implants? A systematic review of the literature.

PubMed

Manfredini, Daniele; Poggio, Carlo E; Lobbezoo, Frank

2014-06-01

To systematically review the literature on the role of bruxism as a risk factor for the different complications on dental implant-supported rehabilitations. A systematic search in the National Library of Medicine's Medline Database was performed to identify all peer-reviewed papers in the English literature assessing the role of bruxism, as diagnosed with any other diagnostic approach (i.e., clinical assessment, questionnaires, interviews, polysomnography, and electromyography), as a risk factor for biological (i.e., implant failure, implant mobility, and marginal bone loss) or mechanical (i.e., complications or failures of either prefabricated components or laboratory-fabricated suprastructures) complications on dental implant-supported rehabilitations. The selected articles were reviewed according to a structured summary of the articles in relation to four main issues, viz., "P" - patients/problem/population, "I" - intervention, "C" - comparison, and "O" - outcome. A total of 21 papers were included in the review and split into those assessing biological complications (n = 14) and those reporting mechanical complications (n = 7). In general, the specificity of the literature for bruxism diagnosis and for the study of the bruxism's effects on dental implants was low. From a biological viewpoint, bruxism was not related with implant failures in six papers, while results from the remaining eight studies did not allow drawing conclusions. As for mechanical complications, four of the seven studies yielded a positive relationship with bruxism. Bruxism is unlikely to be a risk factor for biological complications around dental implants, while there are some suggestions that it may be a risk factor for mechanical complications. © 2012 Wiley Periodicals, Inc.

System overview of the fully implantable destination therapy--ReinHeart-total artificial heart.

PubMed

Pelletier, Benedikt; Spiliopoulos, Sotirios; Finocchiaro, Thomas; Graef, Felix; Kuipers, Kristin; Laumen, Marco; Guersoy, Dilek; Steinseifer, Ulrich; Koerfer, Reiner; Tenderich, Gero

2015-01-01

Owing to the lack of suitable allografts, the demand for long-term mechanical circulatory support in patients with biventricular end-stage heart failure is rising. Currently available Total Artificial Heart (TAH) systems consist of pump units with only limited durability, percutaneous tubes and bulky external equipment that limit the quality of life. Therefore we are focusing on the development of a fully implantable, highly durable destination therapy total artificial heart. The ReinHeart-TAH system consists of a passively filling pump unit driven by a low-wear linear drive between two artificial ventricles, an implantable control unit and a compliance chamber. The TAH is powered by a transcutaneous energy transmission system. The flow distribution inside the ventricles was analysed by fluid structure interaction simulation and particle image velocimetry measurements. Along with durability tests, the hydrodynamic performance and flow balance capability were evaluated in a mock circulation loop. Animal trials are ongoing. Based on fluid structure interaction simulation and particle image velocimetry, blood stagnation areas have been significantly reduced. In the mock circulation loop the ReinHeart-TAH generated a cardiac output of 5 l/min at an operating frequency of 120 bpm and an aortic pressure of 120/80 mmHg. The highly effective preload sensitivity of the passively filling ventricles allowed the sensorless integration of the Frank Starling mechanism. The ReinHeart-TAH effectively replaced the native heart's function in animals for up to 2 days. In vitro and in vivo testing showed a safe and effective function of the ReinHeart-TAH system. This has the potential to become an alternative to transplantation. However, before a first-in-man implant, chronic animal trials still have to be completed. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Assessment of reliability of CAD-CAM tooth-colored implant custom abutments.

PubMed

Guilherme, Nuno Marques; Chung, Kwok-Hung; Flinn, Brian D; Zheng, Cheng; Raigrodski, Ariel J

2016-08-01

Information is lacking about the fatigue resistance of computer-aided design and computer-aided manufacturing (CAD-CAM) tooth-colored implant custom abutment materials. The purpose of this in vitro study was to investigate the reliability of different types of CAD-CAM tooth-colored implant custom abutments. Zirconia (Lava Plus), lithium disilicate (IPS e.max CAD), and resin-based composite (Lava Ultimate) abutments were fabricated using CAD-CAM technology and bonded to machined titanium-6 aluminum-4 vanadium (Ti-6Al-4V) alloy inserts for conical connection implants (NobelReplace Conical Connection RP 4.3×10 mm; Nobel Biocare). Three groups (n=19) were assessed: group ZR, CAD-CAM zirconia/Ti-6Al-4V bonded abutments; group RC, CAD-CAM resin-based composite/Ti-6Al-4V bonded abutments; and group LD, CAD-CAM lithium disilicate/Ti-6Al-4V bonded abutments. Fifty-seven implant abutments were secured to implants and embedded in autopolymerizing acrylic resin according to ISO standard 14801. Static failure load (n=5) and fatigue failure load (n=14) were tested. Weibull cumulative damage analysis was used to calculate step-stress reliability at 150-N and 200-N loads with 2-sided 90% confidence limits. Representative fractured specimens were examined using stereomicroscopy and scanning electron microscopy to observe fracture patterns. Weibull plots revealed β values of 2.59 for group ZR, 0.30 for group RC, and 0.58 for group LD, indicating a wear-out or cumulative fatigue pattern for group ZR and load as the failure accelerating factor for groups RC and LD. Fractographic observation disclosed that failures initiated in the interproximal area where the lingual tensile stresses meet the compressive facial stresses for the early failure specimens. Plastic deformation of titanium inserts with fracture was observed for zirconia abutments in fatigue resistance testing. Significantly higher reliability was found in group ZR, and no significant differences in reliability were determined between groups RC and LD. Differences were found in the failure characteristics of group ZR between static and fatigue loading. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Intricate Assessment and Evaluation of Effect of Bruxism on Long-term Survival and Failure of Dental Implants: A Comparative Study.

PubMed

Yadav, Kajal; Nagpal, Abhishek; Agarwal, S K; Kochhar, Aarti

2016-08-01

Dental implants are one of the common lines of treatment used for the treatment of missing tooth. Various risk factors are responsible for the failure of the dental implants and occurrence of postoperative complications. Bruxism is one such factor responsible for the failure of the dental implants. The actual relation between bruxism and dental implants is a subject of long-term controversy. Hence, we carried out this retrospective analysis to assess the complications occurring in dental implants in patients with and without bruxism. The present study included 1100 patients which were treated for rehabilitation by dental implant procedure at 21 dental offices of Ghaziabad (India) from 2004 to 2014. Analyzing the clinical records of the patients along with assessing the photographs of the patients was done for confirming the diagnosis of bruxism. Clinical re-evaluation of the patients, who came back for follow-up, was done to confirm the diagnosis of bruxism. Systemic questionnaires as used by previous workers were used to evaluate the patients about the self-conscience of the condition. Estimation of the mechanical complications was done only in those cases which occurred on the surfaces of the restoration of the dental implants. All the results were analyzed by Statistical Package for Social Sciences (SPSS) software. Student's t-test and Pearson's chi-square test were used to evaluate the level of significance. In both bruxer and non-bruxers, maximum number of dental implants was placed in anterior maxillary region. Significant difference was obtained while comparing the two groups for dimensions of the dental implants used. On comparing the total implant failed cases between bruxers and non-bruxers group, statistically significant result was obtained. Statistically significant difference was obtained while comparing the two study groups based on the health parameters, namely hypertension, diabetes, and smoking habit. Success of dental implant is significantly affected by bruxism. Special attention is required in such patients while doing treatment planning. For the long-term clinical success and survival of dental implants in patients, special emphasis should be given on the patient's deleterious oral habits, such as bruxism as in long run, they influence the stability of dental implants.

Results following implantation of mechanical circulatory support systems: The Montreal Heart Institute experience

PubMed Central

El-Hamamsy, Ismaïl; Jacques, Frédéric; Perrault, Louis P; Bouchard, Denis; Demers, Philippe; White, Michel; Pelletier, Guy B; Racine, Normand; Pellerin, Michel; Carrier, Michel

2009-01-01

BACKGROUND: Mechanical circulatory support systems (MCSS) have been available in Canada since 1986. Accepted indications include bridging to transplantation or recovery. The present study reviewed the results following MCSS implantation at the Montreal Heart Institute (Montreal, Quebec). METHODS: From September 1987 to September 2006, 43 MCSS were implanted (32 Thoratec [Thoratec Corporation, USA], nine Cardio West TAH [SynCardia Systems Inc, USA], two Novacor [World Heart Corporation, Canada]) in 43 patients (mean [± SD] age 44±13 years; range 19 to 64 years). Indications for implantation included cardiogenic shock due to ischemic (n=19), viral (n=10) or other types of cardiomyopathies (n=14). RESULTS: The mean ejection fraction before implantation was 17.6±6.5% (range 10% to 45%). Before MCSS implantation, most patients showed signs of end-organ failure, including mechanical ventilation (77%), central venous pressure higher than 16 mmHg (44%), oliguria (35%) and hepatic dysfunction (19%). The mean duration of MCSS support was 22.8±32.8 days (range one to 158 days). Survival to transplantation or recovery was 74%. Only one patient was successfully bridged to recovery. Complications were common during MCSS support. They included re-exploration for bleeding (47%), respiratory failure (44%), renal failure requiring temporary dialysis (40%), infection (33%) and neurological events (16%). Only one patient had device failure. In patients successfully bridged to transplantation, early actuarial survival (one month) following transplantation averaged 71±8% and was 57±9% at one year. CONCLUSION: MCSS support with a left ventricular assist device or a total artificial heart provides an effective means of bridging terminally ill patients to transplantation or recovery. Early survival after transplantation shows satisfactory results. However, these results come at the expense of frequent device-related complications, and device failure remains a constant threat. PMID:19214294

All-on-4® Treatment Concept for the Rehabilitation of the Completely Edentulous Mandible: A 7-Year Clinical and 5-Year Radiographic Retrospective Case Series with Risk Assessment for Implant Failure and Marginal Bone Level.

PubMed

Maló, Paulo; de Araújo Nobre, Miguel; Lopes, Armando; Ferro, Ana; Gravito, Inês

2015-10-01

Studies are needed to evaluate long-term outcomes of the All-on-4® treatment concept (Nobel Biocare AB) for rehabilitation of edentulous mandibles by assessing marginal bone levels and risk indicators for implant failure. To evaluate 7-year clinical outcomes and 5-year radiographic outcomes of the All-on-4 treatment concept. This retrospective case series included patients admitted for implant rehabilitations in the mandible, who were followed for 7 years clinically and 5 years radiographically. Primary outcome measures were cumulative prosthetic and implant survival using patient as the unit of analysis (Kaplan-Meier product limit estimator). Secondary outcome measure was marginal bone level (MBL) at 5 years. Variables associated with implant failure were analyzed using the Cox proportional hazards regression model to calculate hazard ratios (HRs) with 95% confidence intervals (CIs). Binary logistic regression was used to compute odds ratio (OR) with 95% CIs for variables associated with MBL ≥2.8 mm at 5 years. A total of 324 patients (194 women, 130 men, average age = 58.9 years) were rehabilitated with 1,296 implants supporting 324 full-arch fixed immediately loaded mandibular prostheses. Sixty-four patients (19.8%) were lost to follow-up. Prosthetic survival was 323/324 (99.7%), and 14 patients lost 18 implants, with an estimated cumulative survival rate of 95.4% at 7 years. Variables associated with implant failure were smoking (HR = 5.28; 95% CI: 1.33, 20.91]) and the learning curve effect (0.69 < HR < 0.33 for more experienced levels). Mean MBL at 5 years was 1.81 mm (95% CI: 1.70, 1.92), and smoking was associated with MBL ≥2.8 mm (OR = 2.4; 95% CI: 1.02, 5.62). The high implant and prosthetic survival rates and excellent MBL outcome confirm the predictability and safety of the All-on-4 treatment concept over a longer term than previously reported. © 2014 Wiley Periodicals, Inc.

To ventricular assist devices or not: When is implantation of a ventricular assist device appropriate in advanced ambulatory heart failure?

PubMed Central

Cerier, Emily; Lampert, Brent C; Kilic, Arman; McDavid, Asia; Deo, Salil V; Kilic, Ahmet

2016-01-01

Advanced heart failure has been traditionally treated via either heart transplantation, continuous inotropes, consideration for hospice and more recently via left ventricular assist devices (LVAD). Heart transplantation has been limited by organ availability and the futility of other options has thrust LVAD therapy into the mainstream of therapy for end stage heart failure. Improvements in technology and survival combined with improvements in the quality of life have made LVADs a viable option for many patients suffering from heart failure. The question of when to implant these devices in those patients with advanced, yet still ambulatory heart failure remains a controversial topic. We discuss the current state of LVAD therapy and the risk vs benefit of these devices in the treatment of heart failure. PMID:28070237

Life prediction of different commercial dental implants as influence by uncertainties in their fatigue material properties and loading conditions.

PubMed

Pérez, M A

2012-12-01

Probabilistic analyses allow the effect of uncertainty in system parameters to be determined. In the literature, many researchers have investigated static loading effects on dental implants. However, the intrinsic variability and uncertainty of most of the main problem parameters are not accounted for. The objective of this research was to apply a probabilistic computational approach to predict the fatigue life of three different commercial dental implants considering the variability and uncertainty in their fatigue material properties and loading conditions. For one of the commercial dental implants, the influence of its diameter in the fatigue life performance was also studied. This stochastic technique was based on the combination of a probabilistic finite element method (PFEM) and a cumulative damage approach known as B-model. After 6 million of loading cycles, local failure probabilities of 0.3, 0.4 and 0.91 were predicted for the Lifecore, Avinent and GMI implants, respectively (diameter of 3.75mm). The influence of the diameter for the GMI implant was studied and the results predicted a local failure probability of 0.91 and 0.1 for the 3.75mm and 5mm, respectively. In all cases the highest failure probability was located at the upper screw-threads. Therefore, the probabilistic methodology proposed herein may be a useful tool for performing a qualitative comparison between different commercial dental implants. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Customizable cap implants for neurophysiological experimentation.

PubMed

Blonde, Jackson D; Roussy, Megan; Luna, Rogelio; Mahmoudian, Borna; Gulli, Roberto A; Barker, Kevin C; Lau, Jonathan C; Martinez-Trujillo, Julio C

2018-04-22

Several primate neurophysiology laboratories have adopted acrylic-free, custom-fit cranial implants. These implants are often comprised of titanium or plastic polymers, such as polyether ether ketone (PEEK). Titanium is favored for its mechanical strength and osseointegrative properties whereas PEEK is notable for its lightweight, machinability, and MRI compatibility. Recent titanium/PEEK implants have proven to be effective in minimizing infection and implant failure, thereby prolonging experiments and optimizing the scientific contribution of a single primate. We created novel, customizable PEEK 'cap' implants that contour to the primate's skull. The implants were created using MRI and/or CT data, SolidWorks software and CNC-machining. Three rhesus macaques were implanted with a PEEK cap implant. Head fixation and chronic recordings were successfully performed. Improvements in design and surgical technique solved issues of granulation tissue formation and headpost screw breakage. Primate cranial implants have traditionally been fastened to the skull using acrylic and anchor screws. This technique is prone to skin recession, infection, and implant failure. More recent methods have used imaging data to create custom-fit titanium/PEEK implants with radially extending feet or vertical columns. Compared to our design, these implants are more surgically invasive over time, have less force distribution, and/or do not optimize the utilizable surface area of the skull. Our PEEK cap implants served as an effective and affordable means to perform electrophysiological experimentation while reducing surgical invasiveness, providing increased strength, and optimizing useful surface area. Crown Copyright © 2018. Published by Elsevier B.V. All rights reserved.

Long-term Survival of Straumann Dental Implants with TPS Surfaces: A Retrospective Study with a Follow-up of 12 to 23 Years.

PubMed

Becker, Stephan T; Beck-Broichsitter, Benedicta E; Rossmann, Christian M; Behrens, Eleonore; Jochens, Arne; Wiltfang, Jörg

2016-06-01

The aim of this study was to evaluate the long-term dental implant survival rates of Straumann dental implants in a university hospital environment over 12 to 23 years. A total of 388 Straumann dental implants with titanium-sprayed surfaces (TPS) were inserted in 92 patients between 1988 and 1999 in the Department of Oral and Maxillofacial Surgery of the University Hospital Schleswig-Holstein in Kiel, and they were reevaluated with standardized clinical and radiological exams. Kaplan-Meier analyses were performed for individual factors. Cox proportional hazard regression analysis was used to detect the factors influencing long-term implant failure. The long-term implant survival rate was 88.03% after an observation time of 12.2 to 23.5 years. Cox regression revealed statistically significant influences of the International Team for Implantology (ITI) implantation type (p = .00354) and tobacco smoking (p = .01264) on implant failure. A proportion 82.8% of the patients with implant losses had a medical history of periodontitis. Peri-implantitis was diagnosed in 9.7% of the remaining implants in the long-term survey. This study emphasized the long-term rehabilitation capabilities of Straumann dental implants in complex cases. The survival rates after several years constitute important information for patients, as well as for clinicians, in deciding about different concepts of tooth replacement. Patient-related and technical factors - determined before implant placement - could help to predict the risk of implant loss. © 2015 Wiley Periodicals, Inc.

A study comparing three different laser-assisted hatching techniques.

PubMed

Ma, B; Wang, Y; Zhang, H; Zhang, X

2014-01-01

Laser-assisted hatching (LAH) is recognized as a useful technology to improve clinical pregnancy rates and implantation rates. This study reports the differences between a new LAH method and two conventional LAH techniques. The authors studied 151 patients with repeated implantation failure, who were divided into three groups. In group 1, the zona pellucida (ZP) was opened using LAH (n = 52). In group 2, laser-assisted thinning was performed to dissolve the outer layer of the ZP (n = 49). In group 3, laser-assisted thinning was performed to dissolve the inner layer of the ZP (n = 50). The clinical pregnancy rates and implantation rates among the groups were compared. The results demonstrate that there are significant differences in the clinical pregnancy rates and implantation rates between group 3 and the other two groups. Performing laser-assisted thinning to dissolve the inner layer of the ZP markedly increases the pregnancy rates and implantation rates of patients with repeated implantation failure.

The Key Points of Maintenance Therapy for Dental Implants: A Literature Review.

PubMed

Pirc, Miha; Dragan, Irina F

2017-04-01

Dental implants require lifelong maintenance and care. Success is defined by biologic factors (presence of inflamed soft tissues surrounding dental implants and radiographic changes in the crestal bone levels) and mechanical factors (stability of the implant fixture and implant supported restoration, etc). Most implant failures are initiated by incipient stages of inflammatory processes, which lead to peri-mucositis and peri-implantitis. The evidence regarding the value of maintenance protocol regarding implants is sparse compared with the one for teeth. This article addresses the existing literature on processes for oral hygiene for implant care.

[A European discussion about stem cells for therapeutic use].

PubMed

Boer, G J

2002-06-29

Stem cells as a source material for growing cellular transplants to repair dysfunctional organs appear to be a new challenge for medical science. Though stem cells are also present in foetal and adult organs, embryonic stem cells from the pre-implantation embryo in particular have the potency to proliferate easily in vitro and the capacity to differentiate into all the body's organ-specific cells. Therefore, these are the ideal cells for developing new cell transplantation therapies for diseases such as Parkinson's disease, diabetes mellitus and heart failure. The use of spare in vitro fertilization (IVF) embryos or pre-implantation embryos specially created to harvest human embryonic stem cells is, however, controversial and an ethical problem. In a European discussion platform organised by the European Commission Research Directorate-General, the status quo of the progress was presented and subsequently commented upon and discussed in terms of medical-ethical, social, industrial and patient interests. The expectations of this new medical technology were high, but clinical trials seem only acceptable once the in vitro differentiation of stem cells can be adequately controlled and once it is known how in vitro prepared stem cells behave after implantation. The ethical justification of the use of in vitro pre-implantation embryos remains controversial. The prevailing view is that the interests of severely ill patients for whom no adequate therapy exists, surmounts the interest of protection of a human in vitro pre-implantation embryo, regardless of whether it was the result of IVF or of transplantation of a somatic cell nucleus of the patient in an enucleated donor egg cell (therapeutic cloning).

Analysis of complications following augmentation with cancellous block allografts.

PubMed

Chaushu, Gavriel; Mardinger, Ofer; Peleg, Michael; Ghelfan, Oded; Nissan, Joseph

2010-12-01

Bone grafting may be associated with soft and hard tissue complications. Recipient site complications encountered using cancellous block allografts for ridge augmentation are analyzed. A total of 101 consecutive patients (62 females and 39 males; mean age 44 ± 17 years) were treated with implant-supported restoration of 137 severe atrophic alveolar ridges augmented with cancellous bone-block allografts. Alveolar ridge deficiency locations were classified as anterior maxilla (n = 58); posterior maxilla (n = 32 sinuses); posterior mandible (n = 32); and anterior mandible (n = 15). A total of 271 rough-surface implants were placed. Recipient site complications associated with block grafting (infection, membrane exposure, incision line opening, perforation of mucosa over the grafted bone, partial graft failure, total graft failure, and implant failure) were recorded. Partial and total bone-block graft failure occurred in 10 (7%) and 11 (8%) of 137 augmented sites, respectively. Implant failure rate was 12 (4.4%) of 271. Soft tissue complications included membrane exposure (42 [30.7%] of 137); incision line opening (41 [30%] of 137); and perforation of the mucosa over the grafted bone (19 [14%] of 137). Infection of the grafted site occurred in 18 (13%) of 137 bone blocks. Alveolar ridge deficiency location had a statistically significant effect on the outcome of recipient site complications. More complications were noted in the mandible compared to the maxilla. Age and gender had no statistically significant effect. Failures caused by complications were rarely noted in association with cancellous block grafting. The incidence of complications in the mandible was significantly higher. Soft tissue complications do not necessarily result in total loss of cancellous block allograft.

Multidisciplinary approach for in-deep assessment of joint prosthesis failure.

PubMed

Tessarolo, F; Caola, I; Piccoli, F; Dorigotti, P; Demattè, E; Molinari, M; Malavolta, M; Barbareschi, M; Caciagli, P; Nollo, G

2009-01-01

In spite of advancement in biomaterials and biomechanics, in development of new osteo-integrative materials and coatings, and in macro- micro- component design, a non negligible fraction of the implanted prosthesis fails before the expected lifetime. A prospective observational clinical study has been conducted to define and apply a set of experimental techniques to in-deep assess the failure of joint prosthesis. Microbiological, histological and micro-structural techniques were implemented to specifically address phenomena occurring at the tissue-implant interface. Results obtained from 27 cases of prosthetic joint failure are discussed in terms of sensitivity and specificity. A procedural flow-chart is finally proposed for the assessment of joint prosthesis failure.

Clinical risk factors related to failures with zirconia-based restorations: an up to 9-year retrospective study.

PubMed

Koenig, Vinciane; Vanheusden, Alain J; Le Goff, Stéphane O; Mainjot, Amélie K

2013-12-01

The first objective of this study was to retrospectively evaluate zirconia-based restorations (ZBR). The second was to correlate failures with clinical parameters and to identify and to analyse chipping failures using fractographic analysis. 147 ZBR (tooth- and implant-supported crowns and fixed partial dentures (FPDs)) were evaluated after a mean observation period of 41.5 ± 31.8 months. Accessorily, zirconia implant abutments (n=46) were also observed. The technical (USPHS criteria) and the biological outcomes of the ZBR were evaluated. Occlusal risk factors were examined: occlusal relationships, parafunctional habits, and the presence of occlusal nightguard. SEM fractographic analysis was performed using the intra-oral replica technique. The survival rate of crowns and FPDs was 93.2%, the success rate was 81.63% and the 9-year Kaplan-Meier estimated success rate was 52.66%. The chipping rate was 15% and the framework fracture rate was 2.7%. Most fractographic analyses revealed that veneer fractures originated from occlusal surface roughness. Several parameters were shown to significantly influence veneer fracture: the absence of occlusal nightguard (p=0.0048), the presence of a ceramic restoration as an antagonist (p=0.013), the presence of parafunctional activity (p=0.018), and the presence of implants as support (p=0.026). The implant abutments success rate was 100%. The results of the present study confirm that chipping is the first cause of ZBR failure. They also underline the importance of clinical parameters in regards to the explanation of this complex problem. This issue should be considered in future prospective clinical studies. Practitioners can reduce chipping failures by taking into account several risk parameters, such as the presence of a ceramic restoration as an antagonist, the presence of parafunctional activity and the presence of implants as support. The use of an occlusal nightguard can also decrease failure rate. Copyright © 2013 Elsevier Ltd. All rights reserved.

Pulse Generator Exchange Does Not Accelerate the Rate of Electrical Failure in a Recalled Small Caliber ICD Lead.

PubMed

Lovelock, Joshua D; Premkumar, Ajay; Levy, Mathew R; Mengistu, Andenet; Hoskins, Michael H; El-Chami, Mikhael F; Lloyd, Michael S; Leon, Angel R; Langberg, Jonathan J; Delurgio, David B

2015-12-01

St. Jude Riata/Riata ST defibrillator leads (St. Jude Medical, Sylmar, CA, USA) were recalled by the Food and Drug Administration in 2011 for an increased rate of failure. More than 227,000 leads were implanted and at least 79,000 patients still have active Riata leads. Studies have examined clinical predictors of lead failure in Riata leads, but none have addressed the effect of implantable cardioverter defibrillator (ICD) generator exchange on lead failure. The purpose of this study is to assess the effect of ICD generator exchange on the rate of electrical failure in the Riata lead at 1 year. A retrospective chart review was conducted in patients who underwent implantation of a Riata/Riata ST lead at one center. Patients with a functioning Riata lead (with/without externalized conductor) at the time of ICD exchange were compared to controls with Riata leads implanted for a comparable amount of time who did not undergo generator replacement. Riata leads were implanted in 1,042 patients prior to the recall and 153 of these patients underwent generator exchange without lead replacement. Conductor externalization was noted in 21.5% of Riata leads in the ICD exchange cohort, which was not different from the control group (19.2%; P = 0.32). Two leads failed in the first year after generator replacement (1.5%) which did not significantly differ from the control group (2.0%; P = 0.57). At change-out, 54% received a commanded shock (18.6 ± 0.9 J) that did not result in any change in the high-voltage lead impedance (46.1 ± 1.1 ohms). Conductor externalization was seen frequently in our cohort of patients. ICD generator exchange did not accelerate the rate of Riata lead failure at 1 year. Although both the control and the change-out cohorts failed at a rate much greater than nonrecalled leads, generator exchange did not appear to add to the problem. ©2015 Wiley Periodicals, Inc.

Uterine Deletion of Gp130 or Stat3 Shows Implantation Failure with Increased Estrogenic Responses

PubMed Central

Sun, Xiaofei; Bartos, Amanda; Whitsett, Jeffrey A.

2013-01-01

Leukemia inhibitory factor (LIF), a downstream target of estrogen, is essential for implantation in mice. LIF function is thought to be mediated by its binding to LIF receptor (LIFR) and recruitment of coreceptor GP130 (glycoprotein 130), and this receptor complex then activates signal transducer and activator of transcription (STAT)1/3. However, the importance of LIFR and GP130 acting via STAT3 in implantation remains uncertain, because constitutive inactivation of Lifr, Gp130, or Stat3 shows embryonic lethality in mice. To address this issue, we generated mice with conditional deletion of uterine Gp130 or Stat3 and show that both GP130 and STAT3 are critical for uterine receptivity and implantation. Implantation failure in these deleted mice is associated with higher uterine estrogenic responses prior to the time of implantation. These heightened estrogenic responses are not due to changes in ovarian hormone levels or expression of their nuclear receptors. In the deleted mice, estrogen-responsive gene, Lactoferrin (Ltf), and Mucin 1 protein, were up-regulated in the uterus. In addition, progesterone-responsive genes, Hoxa10 and Indian hedgehog (Ihh), were markedly down-regulated in STAT3-inactivated uteri. These changes in uteri of deleted mice were reflected by the failure of differentiation of the luminal epithelium, which is essential for blastocyst attachment. PMID:23885093

Fixation strength of a polyetheretherketone femoral component in total knee arthroplasty.

PubMed

de Ruiter, Lennert; Janssen, Dennis; Briscoe, Adam; Verdonschot, Nico

2017-11-01

Introducing polyetheretherketone (PEEK) polymer as a material for femoral components in total knee arthroplasty (TKA) could potentially lead to a reduction of the cemented fixation strength. A PEEK implant is more likely to deform under high loads, rendering geometrical locking features less effective. Fixation strength may be enhanced by adding more undercuts or specific surface treatments. The aim of this study is to measure the initial fixation strength and investigate the associated failure patterns of three different iterations of PEEK-OPTIMA ® implants compared with a Cobalt-Chromium (CoCr) component. Femoral components were cemented onto trabecular bone analogue foam blocks and preconditioned with 86,400 cycles of compressive loading (2600 N-260 N at 1 Hz). They were then extracted while the force was measured and the initial failure mechanism was recorded. Four groups were compared: CoCr, regular PEEK, PEEK with an enhanced cement-bonding surface and the latter with additional surface primer. The mean pull-off forces for the four groups were 3814 N, 688 N, 2525 N and 2552 N, respectively. The initial failure patterns for groups 1, 3 and 4 were the same; posterior condylar foam fracture and cement-bone debonding. Implants from group 2 failed at the cement-implant interface. This study has shown that a PEEK-OPTIMA ® femoral TKA component with enhanced macro- and microtexture is able to replicate the main failure mechanism of a conventional CoCr femoral implant. The fixation strength is lower than for a CoCr implant, but substantially higher than loads occurring under in-vivo conditions. Copyright © 2017 IPEM. Published by Elsevier Ltd. All rights reserved.

Feasibility and Association of Neurohumoral Blocker Up-titration After Cardiac Resynchronization Therapy.

PubMed

Martens, Pieter; Verbrugge, Frederik H; Nijst, Petra; Bertrand, Philippe B; Dupont, Matthias; Tang, Wilson H; Mullens, Wilfried

2017-08-01

Cardiac resynchronization therapy (CRT) improves mortality and morbidity on top of optimal medical therapy in heart failure with reduced ejection fraction (HFrEF). This study aimed to elucidate the association between neurohumoral blocker up-titration after CRT implantation and clinical outcomes. Doses of angiotensin-converting enzyme inhibitors (ACE-Is), angiotensin receptor blockers (ARBs), and beta-blockers were retrospectively evaluated in 650 consecutive CRT patients implanted from October 2008 to August 2015 and followed in a tertiary multidisciplinary CRT clinic. All 650 CRT patients were on a maximal tolerable dose of ACE-I/ARB and beta-blocker at the time of CRT implantation. However, further up-titration was successful in 45.4% for ACE-I/ARB and in 56.8% for beta-blocker after CRT-implantation. During a mean follow-up of 37 ± 22 months, a total of 139 events occurred for the combined end point of heart failure admission and all-cause mortality. Successful, versus unsuccessful, up-titration was associated with adjusted hazard ratios of 0.537 (95% confidence interval 0.316-0.913; P = .022) for ACE-I/ARB and 0.633 (0.406-0.988; P = .044) for beta-blocker on the combined end point heart failure admission and all-cause mortality. Patients in the up-titration group exhibited a similar risk for death or heart failure admission as patients treated with the maximal dose (ACE-I/ARB: P = .133; beta-blockers: P = .709). After CRT, a majority of patients are capable of tolerating higher dosages of neurohumoral blockers. Up-titration of neurohumoral blockers after CRT implantation is associated with improved clinical outcomes, similarly to patients treated with the guideline-recommended target dose at the time of CRT implantation. Copyright © 2017 Elsevier Inc. All rights reserved.

Influences of granulocyte growth factor in uterine perfusion on pregnancy outcome of patients with failure of embryo implantation for unknown reason.

PubMed

He, Jun; Liu, Juan; Zhou, Hua; Chen, Chao Jun

2016-11-01

To investigate the influence of granulocyte growth factor in uterine perfusion on the pregnancy outcome of patients with failure of embryo implantation for unknown reason. Then, 68 patients with failure of embryo implantation for unknown reason were enrolled in our hospital from November 2013 to February 2015, which were divided into observation group and control group by random (34 patients in each group). Patients in observation group received basic treatment for granulocyte growth factor in uterine perfusion on the next day, while patients in control group received basic treatment with placebo. Then, endometrial preparation, adverse reaction and pregnancy outcome of patients were compared between the two groups. Comparing the endometrial preparation and average endometrial thickness of patients in control group (9.87±2.12) with those in observation group [(9.87±2.12), there is no significant difference (P<0.05). After treatment, patients in both groups performed diabetes, hypertension and other pregnancy complications without difference of statistical significance (P<0.05). The embryo implantation rate and clinical pregnancy rate of patients in observation group were significantly higher than those in control group [(82.35%) and (44.12%) vs (52.94%) and (17.65%)]. Moreover, the live birth rate of patients in observation group performed significantly higher than that in control group [(41.18%) vs (14.71%)] with significant difference (P<0.05). By taking treatment of granulocyte growth factor, patients with failure of embryo implantation can effectively improve clinical pregnancy rate and embryo implantation rate without severe complication. Therefore, treatment of granlocyte growth factor can improve the pregnancy outcome of patients.

[Safety profile of etonogestrel contraceptive implant (Nexplanon® and Implanon®) reported in France].

PubMed

Simon, C; Agier, M S; Béné, J; Muller, C; Vrignaud, L; Marret, H; Jonville-Bera, A P

2016-11-01

The aim of the study was to assess the incidence of adverse effects (AE) reported with etonogestrel contraceptive implant in France (Implanon ® and Nexplanon ® ). All cases of AE or unintended pregnancies reported to health authorities or to the firm were analyzed. During 10 years, 5433 AE and 789 unintended pregnancies were reported. Only 388 (7 %) were serious. There were 1137 reports of difficulties to remove, failure to locate or migration, 430 of insertion difficulties and 203 of deformation or expulsion of the implant. Among other AE, the most common were 1694 gynecological AE, 524 skin reactions and 437 metabolic AE. Since the marketing of Nexplanon ® which causes less deep insertions, the incidence of migrations, removal or insertion difficulties has decreased overall (0.92 vs. 1.31/1000 patients), particularly the incidence of removal difficulties, location failures or migrations (0.12 vs 1.01/1000). The infrequent but serious AE were infectious complications at the implant site and pregnancies. When the circumstances of the pregnancy were known, the contraceptive failure was due to the apparent inefficiency of the implant (n=224), to a technique failure (n=203) or to a drug-drug interaction (n=59). This study confirms that AE of this implant are frequent but not serious, except for the pregnancies. The incidence of complications related to insertion decreased with Nexplanon ® . Among other preventable AE, unintended pregnancies due to a drug-drug interaction would require to be better known by the practitioner. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Clinical trials update from the American Heart Association: REPAIR-AMI, ASTAMI, JELIS, MEGA, REVIVE-II, SURVIVE, and PROACTIVE.

PubMed

Cleland, John G F; Freemantle, Nick; Coletta, Alison P; Clark, Andrew L

2006-01-01

This article provides information and a commentary on trials presented at the American Heart Association meeting held in November 2005, relevant to the pathophysiology, prevention and treatment of heart failure. All reports should be considered as preliminary data, as analyses may change in the final publication. In REPAIR-AMI an improvement in ejection fraction was observed in post-MI patients following infusion of bone marrow stem cells. However, the ASTAMI study showed no benefit of stem cell implantation in a similar patient cohort. The JELIS study reported a reduction in major coronary events in patients receiving statins plus fish oil compared to statins alone. MEGA showed that low dose statins in a low risk population reduce the incidence of major cardiovascular events. Two studies of levosimendan in acute heart failure gave conflicting results, in the REVIVE-II study levosimendan was reported to have a superior effect on the composite primary outcome compared to placebo, however, in SURVIVE despite a trend to early benefit with levosimendan, there was no difference in effect on long-term outcome versus dobutamine. The PROACTIVE study showed encouraging results for the use of pioglitazone in post-myocardial infarction patients with concomitant type 2 diabetes.

Total Artificial Heart Implantation Blood Pressure Management as Resolving Treatment for Massive Hemolysis following Total Artificial Heart Implantation.

PubMed

Ghodsizad, Ali; Koerner, Michael M; El-Banayosy, A; Zeriouh, Mohamed; Ruhparwar, Arjang; Loebe, Matthias

2016-10-21

The SynCardia Total Artificial Heart (TAH) has been used for patients with biventricular failure, who cannot be managed with implantation of a left ventricular (LV) assist device. Following TAH implantation, our patient developed severe hemolysis, which could only be managed successfully by aggressive blood pressure control [Ohashi 2003; Nakata 1998].

X-ray absorption fine structure (XAFS) analysis of titanium-implanted soft tissue.

PubMed

Uo, Motohiro; Asakura, Kiyotaka; Yokoyama, Atsuro; Ishikawa, Makoto; Tamura, Kazuchika; Totsuka, Yasunori; Akasaka, Tsukasa; Watari, Fumio

2007-03-01

Tissues contacting Ti dental implants were subjected to X-ray absorption fine structure (XAFS) analysis to examine the chemical state of Ti transferred from the placed implant into the surrounding tissue. Nine tissues that contacted pure Ti cover screws for several months were excised in a second surgery whereby healing abutments were set. Six tissues that surrounded implants retrieved due to their failure were also excised. Ti distributions in the excised specimens were confirmed by X-ray scanning analytical microscopy (XSAM), and the specimens were subjected to fluorescence XAFS analysis to determine the chemical states of the low concentrations of Ti in the tissues surrounding Ti dental implants. Ti mostly existed in the metallic state and was considered to be debris derived from the abrasion of implant pieces during implant surgery. Oxidized forms of Ti, such as anatase and rutile, were also detected in a few specimens-and existed in either a pure state or mixed state with metallic Ti. It was concluded that the existence of Ti in the tissue did not cause implant failure. Moreover, the usefulness of XAFS for analysis of the chemical states of rarely contained elements in biological tissue was demonstrated.

5-Year Safety and Efficacy of Resolute Zotarolimus-Eluting Stent: The RESOLUTE Global Clinical Trial Program.

PubMed

Yeh, Robert W; Silber, Sigmund; Chen, Lianglong; Chen, Shaoliang; Hiremath, Shirish; Neumann, Franz-Josef; Qiao, Shubin; Saito, Shigeru; Xu, Bo; Yang, Yuejin; Mauri, Laura

2017-02-13

The authors evaluated the 5-year cumulative incidence of cardiovascular events following Resolute zotarolimus-eluting stent (R-ZES) implantation. Individual trials are often underpowered to show differences for low-frequency adverse events. The R-ZES was studied in 10 prospective clinical trials, designed with identical adverse event definitions, ascertainment, and adjudication. The RESOLUTE Global Clinical Trial Program includes 7,618 patients treated with R-ZES: RESOLUTE first-in-human study (N = 139), RESOLUTE All Comers (N = 1,140), RESOLUTE International (N = 2,349), RESOLUTE US (N = 1,402), RESOLUTE US 38 mm (N = 114), RESOLUTE Japan (N = 100), RESOLUTE Japan Small Vessel Study (N = 65), RESOLUTE Asia (N = 311), RESOLUTE China Randomized Controlled Trial (N = 198), and RESOLUTE China Registry (N = 1,800). The 5-year cumulative incidence of events was calculated. The 5-year cumulative incidence of cardiac events was 13.4% for target lesion failure and included 5.0% cardiac death, 4.4% target vessel myocardial infarction, and 6.3% clinically driven target lesion revascularization. Dual-antiplatelet therapy at 1, 3, and 5 years was 91%, 37%, and 32%, respectively. The 5-year cumulative incidence of definite or probable stent thrombosis was 1.2%, which comprised 0.7% at 1 year and an annualized rate of 0.1% thereafter. Five-year use of dual-antiplatelet therapy varied geographically from 63% in Japan to 11% in Europe. In the largest group of R-ZES patients examined to date, the majority of stent-related events, including target vessel myocardial infarction and stent thrombosis, occurred within the first year of implantation with much lower risks of these events out to 5 years. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Bioengineered human acellular vessels for dialysis access in patients with end-stage renal disease: two phase 2 single-arm trials

PubMed Central

Lawson, Jeffrey H; Glickman, Marc H; Ilzecki, Marek; Jakimowicz, Tomasz; Jaroszynski, Andrzej; Peden, Eric K; Pilgrim, Alison J; Prichard, Heather L; Guziewicz, Malgorzata; Przywara, Stanisław; Szmidt, Jacek; Turek, Jakub; Witkiewicz, Wojciech; Zapotoczny, Norbert; Zubilewicz, Tomasz; Niklason, Laura E

2016-01-01

Summary Background For patients with end-stage renal disease who are not candidates for fistula, dialysis access grafts are the best option for chronic haemodialysis. However, polytetrafluoroethylene arteriovenous grafts are prone to thrombosis, infection, and intimal hyperplasia at the venous anastomosis. We developed and tested a bioengineered human acellular vessel as a potential solution to these limitations in dialysis access. Methods We did two single-arm phase 2 trials at six centres in the USA and Poland. We enrolled adults with end-stage renal disease. A novel bioengineered human acellular vessel was implanted into the arms of patients for haemodialysis access. Primary endpoints were safety (freedom from immune response or infection, aneurysm, or mechanical failure, and incidence of adverse events), and efficacy as assessed by primary, primary assisted, and secondary patencies at 6 months. All patients were followed up for at least 1 year, or had a censoring event. These trials are registered with ClinicalTrials.gov, NCT01744418 and NCT01840956. Findings Human acellular vessels were implanted into 60 patients. Mean follow-up was 16 months (SD 7·6). One vessel became infected during 82 patient-years of follow-up. The vessels had no dilatation and rarely had post-cannulation bleeding. At 6 months, 63% (95% CI 47–72) of patients had primary patency, 73% (57–81) had primary assisted patency, and 97% (85–98) had secondary patency, with most loss of primary patency because of thrombosis. At 12 months, 28% (17–40) had primary patency, 38% (26–51) had primary assisted patency, and 89% (74–93) had secondary patency. Interpretation Bioengineered human acellular vessels seem to provide safe and functional haemodialysis access, and warrant further study in randomised controlled trials. Funding Humacyte and US National Institutes of Health. PMID:27203778

Left Ventricular Assist Device Implantation with Concomitant Aortic Valve and Ascending Aortic Replacement

PubMed Central

Panholzer, Bernd; Cremer, Jochen; Haneya, Assad

2018-01-01

Left ventricular assist device (LVAD) is nowadays a routine therapy for patients with advanced heart failure. We present the case of a 74-year-old male patient who was admitted to our center with terminal heart failure in dilated cardiomyopathy and ascending aortic aneurysm with aortic valve regurgitation. The LVAD implantation with simultaneous aortic valve and supracoronary ascending aortic replacement was successfully performed. PMID:29552039

Left Ventricular Assist Device Implantation with Concomitant Aortic Valve and Ascending Aortic Replacement.

PubMed

Huenges, Katharina; Panholzer, Bernd; Cremer, Jochen; Haneya, Assad

2018-01-01

Left ventricular assist device (LVAD) is nowadays a routine therapy for patients with advanced heart failure. We present the case of a 74-year-old male patient who was admitted to our center with terminal heart failure in dilated cardiomyopathy and ascending aortic aneurysm with aortic valve regurgitation. The LVAD implantation with simultaneous aortic valve and supracoronary ascending aortic replacement was successfully performed.

Corrosion and fatigue of surgical implants

NASA Technical Reports Server (NTRS)

Lisagor, W. B.

1975-01-01

Implants for the treatment of femoral fractures, mechanisms leading to the failure or degradation of such structures, and current perspectives on surgical implants are discussed. Under the first heading, general usage, materials and procedures, environmental conditions, and laboratory analyses of implants after service are considered. Corrosion, crevice corrosion, stress corrosion cracking, intergranular corrosion, pitting corrosion, fatigue, and corrosion fatigue are the principal degradation mechanisms described. The need for improvement in the reliability of implants is emphasized.

Externalized conductors and insulation failure in Biotronik defibrillator leads: History repeating or a false alarm?

PubMed

De Maria, Elia; Borghi, Ambra; Bonetti, Lorenzo; Fontana, Pier Luigi; Cappelli, Stefano

2017-02-16

Conductor externalization and insulation failure are frequent complications with the recalled St. Jude Medical Riata implantable cardioverter-defibrillator (ICD) leads. Conductor externalization is a "unique" failure mechanism: Cables externalize through the insulation ("inside-out" abrasion) and appear outside the lead body. Recently, single reports described a similar failure also for Biotronik leads. Moreover, some studies reported a high rate of electrical dysfunction (not only insulation failure) with Biotronik Linox leads and a reduced survival rate in comparison with the competitors. In this paper we describe the case of a patient with a Biotronik Kentrox ICD lead presenting with signs of insulation failure and conductor externalization at fluoroscopy. Due to the high risk of extraction we decided to implant a new lead, abandoning the damaged one; lead reimplant was uneventful. Subsequently, we review currently available literature about Biotronik Kentrox and Linox ICD lead failure and in particular externalized conductors. Some single-center studies and a non-prospective registry reported a survival rate between 88% and 91% at 5 years for Linox leads, significantly worse than that of other manufacturers. However, the preliminary results of two ongoing multicenter, prospective registries (GALAXY and CELESTIAL) showed 96% survival rate at 5 years after implant, well within industry standards. Ongoing data collection is needed to confirm longer-term performance of this family of ICD leads.

Externalized conductors and insulation failure in Biotronik defibrillator leads: History repeating or a false alarm?

PubMed Central

De Maria, Elia; Borghi, Ambra; Bonetti, Lorenzo; Fontana, Pier Luigi; Cappelli, Stefano

2017-01-01

Conductor externalization and insulation failure are frequent complications with the recalled St. Jude Medical Riata implantable cardioverter-defibrillator (ICD) leads. Conductor externalization is a “unique” failure mechanism: Cables externalize through the insulation (“inside-out” abrasion) and appear outside the lead body. Recently, single reports described a similar failure also for Biotronik leads. Moreover, some studies reported a high rate of electrical dysfunction (not only insulation failure) with Biotronik Linox leads and a reduced survival rate in comparison with the competitors. In this paper we describe the case of a patient with a Biotronik Kentrox ICD lead presenting with signs of insulation failure and conductor externalization at fluoroscopy. Due to the high risk of extraction we decided to implant a new lead, abandoning the damaged one; lead reimplant was uneventful. Subsequently, we review currently available literature about Biotronik Kentrox and Linox ICD lead failure and in particular externalized conductors. Some single-center studies and a non-prospective registry reported a survival rate between 88% and 91% at 5 years for Linox leads, significantly worse than that of other manufacturers. However, the preliminary results of two ongoing multicenter, prospective registries (GALAXY and CELESTIAL) showed 96% survival rate at 5 years after implant, well within industry standards. Ongoing data collection is needed to confirm longer-term performance of this family of ICD leads. PMID:28255544

Primary Prevention Implantable Cardioverter-Defibrillators and Survival in Older Women

PubMed Central

Zeitler, Emily P.; Hellkamp, Anne S.; Fonarow, Gregg C.; Hammill, Stephen C.; Curtis, Lesley H.; Hernandez, Adrian F.; Al-Khalidi, Hussein R.; Curtis, Jeptha P.; Heidenreich, Paul A.; Anstrom, Kevin J.; Peterson, Eric D.; Mark, Daniel B.; Hammill, Bradley G.; Sanders, Gillian D.; Al-Khatib, Sana M.

2015-01-01

OBJECTIVES The purpose of this study was to assess the benefit of primary prevention implantable cardioverter defibrillators (ICDs) in women. BACKGROUND Clinical trials of primary prevention ICDs enrolled a limited number of women. METHODS Using a propensity score method, we matched 490 women ≥65 years of age who received an ICD during a hospitalization for heart failure in the National Cardiovascular Data Registry ICD Registry from January 1, 2006, through December 31, 2007, to 490 ICD-eligible women without an ICD hospitalized for heart failure in the Get With The Guidelines for Heart Failure database from January 1, 2006, through December 31, 2009. The primary endpoint was all-cause mortality obtained from the Medicare Claims Database. An identical analysis was conducted in men. RESULTS Median follow-up for patients with an ICD was 4.6 years versus 3.2 years for patients with no ICD. Compared with women with no ICD, those with an ICD were younger and less frequently white. In the matched cohorts, the survival of women with an ICD was significantly longer than that of women without an ICD (adjusted hazard ratio: 0.79, 95% confidence interval: 0.66 to 0.95; p = 0.013). Similarly, men with an ICD had longer survival than men without an ICD (adjusted hazard ratio: 0.73, 95% confidence interval: 0.65 to 0.83; p < 0.0001). There was no interaction between sex and the presence of an ICD with respect to survival (p = 0.44). CONCLUSIONS Among older women with left ventricular dysfunction, a primary prevention ICD was associated with a significant survival benefit that was nearly identical to that seen in men. These findings support the use of primary prevention ICDs in eligible patients regardless of sex. PMID:25543969

Success rates and factors associated with failure of temporary anchorage devices: A prospective clinical trial.

PubMed

Aly, Shehab A; Alyan, Doha; Fayed, Mona S; Alhammadi, Maged S; Mostafa, Yehya A

2018-03-06

The objective of the present study was to investigate success rates and associated factors affecting temporary anchorage device (TAD) failure in different biomechanical applications. A total of 180 TADs were used as a part of 82 patients' treatment plan (24 males and 58 females); their mean age was 21.41 years. Three types of TADs were used: 50 (3M ESPE, Neuss, Germany), 56 (Bone screw; Jeil Medical, Seoul, Korea), and 74 (Morelli, Sorocaba, Brazil). Eight maxillary and four mandibular sites were selected for insertion. Three different lengths (6, 8, and 10 mm) and three different diameters (1.5, 1.6, and 1.8 mm) were used. The force levels were set at 50, 100, 150, 200, and 250 g. Patient-, implant-, and operator-dependent factors were evaluated throughout the 266 days of function. Qualitative variables were described by proportions and percentages and analyzed using χ 2 test. The overall success rate was 82.2%. The higher age group showed a significantly higher success rate. Oral hygiene showed a statistically-significant (P ˂ .05) difference between both success and failure groups. All other patient-related factors showed no significant differences. Regarding force levels used, the highest success rate was in 250 g and the lowest was in 100 g. There were no significant differences between both groups regarding other implant- and operator-related factors. Temporary anchorage devices have a good success rate and are beneficial to be integrated in orthodontic treatment planning. Patient age, oral hygiene, and force level are the most significant factors affecting TAD success. © 2018 John Wiley & Sons Australia, Ltd.

Current State and Future Perspectives of Energy Sources for Totally Implantable Cardiac Devices.

PubMed

Bleszynski, Peter A; Luc, Jessica G Y; Schade, Peter; PhilLips, Steven J; Tchantchaleishvili, Vakhtang

There is a large population of patients with end-stage congestive heart failure who cannot be treated by means of conventional cardiac surgery, cardiac transplantation, or chronic catecholamine infusions. Implantable cardiac devices, many designated as destination therapy, have revolutionized patient care and outcomes, although infection and complications related to external power sources or routine battery exchange remain a substantial risk. Complications from repeat battery replacement, power failure, and infections ultimately endanger the original objectives of implantable biomedical device therapy - eliminating the intended patient autonomy, affecting patient quality of life and survival. We sought to review the limitations of current cardiac biomedical device energy sources and discuss the current state and trends of future potential energy sources in pursuit of a lifelong fully implantable biomedical device.

Early Ahmed Glaucoma Valve Implantation after Penetrating Keratoplasty Leads to Better Outcomes in an Asian Population with Preexisting Glaucoma

PubMed Central

Tai, Ming-Cheng; Chen, Yi-Hao; Cheng, Jen-Hao; Liang, Chang-Min; Chen, Jiann-Torng; Chen, Ching-Long; Lu, Da-Wen

2012-01-01

Background To evaluate the efficacy of Ahmed Glaucoma Valve (AGV) surgery and the optimal interval between penetrating keratoplasty (PKP) and AGV implantation in a population of Asian patients with preexisting glaucoma who underwent PKP. Methodology/Principal Findings In total, 45 eyes of 45 patients were included in this retrospective chart review. The final intraocular pressures (IOPs), graft survival rate, and changes in visual acuity were assessed to evaluate the outcomes of AGV implantations in eyes in which AGV implantation occurred within 1 month of post-PKP IOP elevation (Group 1) and in eyes in which AGV implantation took place more than 1 month after the post-PKP IOP evaluation (Group 2). Factors that were associated with graft failure were analyzed, and the overall patterns of complications were reviewed. By their final follow-up visits, 58% of the patients had been successfully treated for glaucoma. After the operation, there were no statistically significant differences between the groups with respect to graft survival (p = 0.98), but significant differences for IOP control (p = 0.049) and the maintenance of visual acuity (VA) (p<0.05) were observed. One year after surgery, the success rates of IOP control in Group 1 and Group 2 were 80% and 46.7%, respectively, and these rates fell to 70% and 37.3%, respectively, by 2 years. Factors that were associated with a high risk of AGV failure were a diagnosis of preexisting angle-closure glaucoma, a history of previous PKP, and a preoperative IOP that was >21 mm Hg. The most common surgical complication, aside from graft failure, was hyphema. Conclusions/Significance Early AGV implantation results in a higher probability of AGV survival and a better VA outcome without increasing the risk of corneal graft failure as a result of post-PKP glaucoma drainage tube implantation. PMID:22629464

Accelerated Implantable Defibrillator Battery Depletion Secondary to Lithium Cluster Formation: A Case Series.

PubMed

Aggarwal, Ashim; Sarmiento, Joseph J; Charles, David R; Parr, Alan R; Baman, Timir S

2016-04-01

Device failure from unanticipated and precipitous battery depletion is uncommon but can be life-threatening. Multiple mechanisms of battery failure have been previously described in the medical literature. However, in this current case series, we describe the largest cohort of patients (n = 4) with St. Jude (St. Paul, MN, USA) early implantable defibrillator battery depletion attributable to lithium cluster formation causing short circuit and high current drain. Clinicians must be aware of this occult cause of device failure and more studies are needed to determine its true prevalence. © 2015 Wiley Periodicals, Inc.

Thymosin β4: Roles in Development, Repair, and Engineering of the Cardiovascular System.

PubMed

Marks, E D; Kumar, A

2016-01-01

The burden of cardiovascular disease is a growing worldwide issue that demands attention. While many clinical trials are ongoing to test therapies for treating the heart after myocardial infarction (MI) and heart failure, there are few options doctors able to currently give patients to repair the heart. This eventually leads to decreased ventricular contractility and increased systemic disease, including vascular disorders that could result in stroke. Small peptides such as thymosin β4 (Tβ4) are upregulated in the cardiovascular niche during fetal development and after injuries such as MI, providing increased neovasculogenesis and paracrine signals for endogenous stem cell recruitment to aid in wound repair. New research is looking into the effects of in vivo administration of Tβ4 through injections and coatings on implants, as well as its effect on cell differentiation. Results so far demonstrate Tβ4 administration leads to robust increases in angiogenesis and wound healing in the heart after MI and the brain after stroke, and can differentiate adult stem cells toward the cardiac lineage for implantation to the heart to increase contractility and survival. Future work, some of which is currently in clinical trials, will demonstrate the in vivo effect of these therapies on human patients, with the goal of helping the millions of people worldwide affected by cardiovascular disease. © 2016 Elsevier Inc. All rights reserved.

The evolution of brachytherapy for prostate cancer.

PubMed

Zaorsky, Nicholas G; Davis, Brian J; Nguyen, Paul L; Showalter, Timothy N; Hoskin, Peter J; Yoshioka, Yasuo; Morton, Gerard C; Horwitz, Eric M

2017-06-30

Brachytherapy (BT), using low-dose-rate (LDR) permanent seed implantation or high-dose-rate (HDR) temporary source implantation, is an acceptable treatment option for select patients with prostate cancer of any risk group. The benefits of HDR-BT over LDR-BT include the ability to use the same source for other cancers, lower operator dependence, and - typically - fewer acute irritative symptoms. By contrast, the benefits of LDR-BT include more favourable scheduling logistics, lower initial capital equipment costs, no need for a shielded room, completion in a single implant, and more robust data from clinical trials. Prospective reports comparing HDR-BT and LDR-BT to each other or to other treatment options (such as external beam radiotherapy (EBRT) or surgery) suggest similar outcomes. The 5-year freedom from biochemical failure rates for patients with low-risk, intermediate-risk, and high-risk disease are >85%, 69-97%, and 63-80%, respectively. Brachytherapy with EBRT (versus brachytherapy alone) is an appropriate approach in select patients with intermediate-risk and high-risk disease. The 10-year rates of overall survival, distant metastasis, and cancer-specific mortality are >85%, <10%, and <5%, respectively. Grade 3-4 toxicities associated with HDR-BT and LDR-BT are rare, at <4% in most series, and quality of life is improved in patients who receive brachytherapy compared with those who undergo surgery.

Outcomes and Complications of Ahmed Tube Implantation in Asian Eyes.

PubMed

Choo, Jessica Qian Hui; Chen, Ziyou David; Koh, Victor; Liang, Shen; Aquino, Cecilia Maria; Sng, Chelvin; Chew, Paul

2018-06-18

There is a lack of long-term Asian studies on the efficacy and safety of Ahmed glaucoma valve (AGV) implantation. This study seeks to determine the outcomes and complications of AGV implantation in Asians. Retrospective review of AGV surgeries performed at a single centre in Singapore was conducted. 76 patients with primary and secondary glaucoma who underwent their first AGV surgery from 1st January 2010 to 31st December 2012 were considered for our study. Primary outcomes evaluated were: failure, intra-ocular pressure, best-corrected visual acuity (BCVA), number of IOP-lowering medications and complications. Failure was defined by: IOP >21▒mm Hg on two consecutive visits after 3 months, IOP ≤5▒mm Hg on two consecutive visits after 3 months, reoperation for glaucoma, removal of implant or loss of light perception vision. Mean follow-up duration was 33.2±6.9 months. There was significant reduction in IOP (mean reduction 25.9%, P<0.001) and number of IOP-lowering medications (mean reduction 77.8%, P<0.001) at 3 years. Absolute failure rate was 23.9% at 3 years with no difference between eyes with or without previous trabeculectomy and between eyes with primary or secondary glaucoma. Occurrence of post-operative hyphema was a significant risk factor for failure. Commonest post-operative complications were hyphema and tube exposure. At 3 years after AGV surgery in Asian eyes, less than one-quarter of the eyes fulfilled the criteria for surgical failure.

A dual-center review of compressive osseointegration for fixation of massive endoprosthetics: 2- to 9-year followup.

PubMed

Calvert, George T; Cummings, Judd E; Bowles, Austin J; Jones, Kevin B; Wurtz, L Daniel; Randall, R Lor

2014-03-01

Aseptic failure of massive endoprostheses used in the reconstruction of major skeletal defects remains a major clinical problem. Fixation using compressive osseointegration was developed as an alternative to cemented and traditional press-fit fixation in an effort to decrease aseptic failure rates. The purpose of this study was to answer the following questions: (1) What is the survivorship of this technique at minimum 2-year followup? (2) Were patient demographic variables (age, sex) or anatomic location associated with implant failure? (3) Were there any prosthesis-related variables (eg, spindle size) associated with failure? (4) Was there a discernible learning curve associated with the use of the new device as defined by a difference in failure rate early in the series versus later on? The first 50 cases using compressive osseointegration fixation from two tertiary referral centers were retrospectively studied. Rates of component removal for any reason and for aseptic failure were calculated. Demographic, surgical, and oncologic factors were analyzed using regression analysis to assess for association with implant failure. Minimum followup was 2 years with a mean of 66 months. Median age at the time of surgery was 14.5 years. A total of 15 (30%) implants were removed for any reason. Of these revisions, seven (14%) were the result of aseptic failure. Five of the seven aseptic failures occurred at less than 1 year (average, 8.3 months), and none occurred beyond 17 months. With the limited numbers available, no demographic, surgical, or prosthesis-related factors correlated with failure. Most aseptic failures of compressive osseointegration occurred early. Longer followup is needed to determine if this technique is superior to other forms of fixation.

A 5-year randomized trial to compare 1 or 2 implants for implant overdentures.

PubMed

Bryant, S R; Walton, J N; MacEntee, M I

2015-01-01

The hypothesis of this 5-y randomized clinical trial was that there would be no significant difference in the satisfaction of edentulous participants with removable complete overdentures attached to 1 or 2 mandibular implants. Secondary aims were to test changes in satisfaction between and within the groups from baseline to 5 y and differences between the groups in implant survival and prosthodontic maintenance over 5 y. Each of the 86 participants (mean age, 67 y) was randomly allocated to receive either 1 implant in the midline (group 1) or 2 implants in the canine areas (group 2) attached to a mandibular overdenture opposing a maxillary complete denture. Satisfaction was self-assessed by participants on a visual analog scale at baseline prior to implants, as well as at 2 mo and 1, 3, and 5 y with implant overdentures, whereas implant survival and prosthodontic maintenance were assessed by clinical examination. After 5 y, 29 participants in group 1 and 33 in group 2 were available, with most dropouts due to death. Satisfaction with the implant denture after 5 y was significantly (P < 0.001) higher than at baseline in both groups and remained with no significant difference (P = 0.32) between the groups. No implants failed in group 1 but 5 failed before loading in 4 participants in group 2. Most participants required maintenance or occasionally denture replacement, and although differences between the groups were not statistically significant, group 1 experienced almost twice as many fractured dentures usually adjacent to the implant attachment. We conclude that there were no significant differences after 5 y in satisfaction or survival of implants with mandibular overdentures retained by 1 implant or 2 implants. Additional research is required to confirm long-term treatment effectiveness of single-implant dentures and the implications of prosthetic maintenance with implant overdentures (ClinicalTrials.gov: NCT02117856). © International & American Associations for Dental Research 2014.

Biomechanical and histologic evaluation of two application forms of surgical glue for mesh fixation to the abdominal wall.

PubMed

Ortillés, Á; Pascual, G; Peña, E; Rodríguez, M; Pérez-Köhler, B; Mesa-Ciller, C; Calvo, B; Bellón, J M

2017-11-01

The use of an adhesive for mesh fixation in hernia repair reduces chronic pain and minimizes tissue damage in the patient. This study was designed to assess the adhesive properties of a medium-chain (n-butyl) cyanoacrylate glue applied as drops or as a spray in a biomechanical and histologic study. Both forms of glue application were compared to the use of simple-loose or continuous-running polypropylene sutures for mesh fixation. Eighteen adult New Zealand White rabbits were used. For mechanical tests in an ex vivo and in vivo study, patches of polypropylene mesh were fixed to an excised fragment of healthy abdominal tissue or used to repair a partial abdominal wall defect in the rabbit respectively. Depending on the fixation method used, four groups of 12 implants each or 10 implants each respectively for the ex vivo and in vivo studies were established: Glue-Drops, Glue-Spray, Suture-Simple and Suture-Continuous. Biomechanical resistance in the ex vivo implants was tested five minutes after mesh fixation. In vivo implants for biomechanical and histologic assessment were collected at 14 days postimplant. In the ex vivo study, the continuous suture implants showed the highest failure sample tension, while the implants fixed with glue showed lower failure sample tension values. However, the simple and continuous suture implants returned the highest stretch values. In the in vivo implants, failure sample tension values were similar among groups while the implants fixed with a continuous running suture had the higher stretch values, and the glue-fixed implants the lower stretch values. All meshes showed good tissue integration within the host tissue regardless of the fixation method used. Our histologic study revealed the generation of a denser, more mature repair tissue when the cyanoacrylate glue was applied as a spray rather than as drops. Copyright © 2017 Elsevier Ltd. All rights reserved.

Investigation of a fatigue failure in a stainless steel femoral plate.

PubMed

Marcomini, J B; Baptista, C A R P; Pascon, J P; Teixeira, R L; Reis, F P

2014-10-01

Surgical implants are exposed to severe working conditions and therefore a wide range of failure mechanisms may occur, including fatigue, corrosion, wear, fretting and combinations of them. The mechanical failures of metallic implants may also be influenced by several other factors, including the design, material, manufacturing, installation, postoperative complications and misuse. An 83-year-old patient suffered an oblique femoral shaft fracture due to a fall at home. A stainless steel locking compression plate (LCP) employed in the fracture reduction failed after four months and was sent back to the producer. A second LCP of the same type was implanted and also failed after six months. A failure analysis of the second femoral LCP is performed in this paper. The results demonstrate that poor material quality was decisive to the failure. The chemical analysis revealed a high P content in the steel, which is not in accordance to the standards. A combination of factors lead to LCP fracture and these include: brittle crack initiation due to phosphorus, segregation at grain boundaries, crack propagation due to cyclic loading and final fast fracture favored by the loss of ductility due to cold work. Copyright © 2014 Elsevier Ltd. All rights reserved.

[Assisted hatching following embryo implantation failure].

PubMed

Carballo Mondragón, Esperanza; Durán Monterrosas, Leonor; Campos Cañas, Jorge A; González de Jesús, Patricia; Kably Ambe, Alberto

2012-08-01

Assisted hatching in reproduction techniques has improved the successful implantation rates in certain groups of patients with poor prognosis. This study focuses on its effect in groups of patients with previous implantation failure and according to age groups. Compare the pregnancy rates of patients who turned to this technique following an implantation failure using in vitro fertilization with those of patients who did not use assisted hatching before another attempt of in vitro fertilization and according to specific age groups. Cases of patients using assisted hatching in our Center between January 2008 and December 2009 were studied. The results were compared in terms of age in three groups: group I, >35 years; group II, 35-39 years, and group III, > 40 years. Patients in group II had better pregnancy rate (30%) than those in groups I and III (16.98 and 20.83%, respectively). When comparing the results of the group of patients using assisted hatching with those of the group that did not, the first reported a 20% pregnancy rate versus no pregnancy in the other group.

Failure mode analysis of silicon-based intracortical microelectrode arrays in non-human primates

PubMed Central

Barrese, James C; Rao, Naveen; Paroo, Kaivon; Triebwasser, Corey; Vargas-Irwin, Carlos; Franquemont, Lachlan; Donoghue, John P

2016-01-01

Objective Brain–computer interfaces (BCIs) using chronically implanted intracortical microelectrode arrays (MEAs) have the potential to restore lost function to people with disabilities if they work reliably for years. Current sensors fail to provide reliably useful signals over extended periods of time for reasons that are not clear. This study reports a comprehensive retrospective analysis from a large set of implants of a single type of intracortical MEA in a single species, with a common set of measures in order to evaluate failure modes. Approach Since 1996, 78 silicon MEAs were implanted in 27 monkeys (Macaca mulatta). We used two approaches to find reasons for sensor failure. First, we classified the time course leading up to complete recording failure as acute (abrupt) or chronic (progressive). Second, we evaluated the quality of electrode recordings over time based on signal features and electrode impedance. Failure modes were divided into four categories: biological, material, mechanical, and unknown. Main results Recording duration ranged from 0 to 2104 days (5.75 years), with a mean of 387 days and a median of 182 days (n = 78). Sixty-two arrays failed completely with a mean time to failure of 332 days (median = 133 days) while nine array experiments were electively terminated for experimental reasons (mean = 486 days). Seven remained active at the close of this study (mean = 753 days). Most failures (56%) occurred within a year of implantation, with acute mechanical failures the most common class (48%), largely because of connector issues (83%). Among grossly observable biological failures (24%), a progressive meningeal reaction that separated the array from the parenchyma was most prevalent (14.5%). In the absence of acute interruptions, electrode recordings showed a slow progressive decline in spike amplitude, noise amplitude, and number of viable channels that predicts complete signal loss by about eight years. Impedance measurements showed systematic early increases, which did not appear to affect recording quality, followed by a slow decline over years. The combination of slowly falling impedance and signal quality in these arrays indicate that insulating material failure is the most significant factor. Significance This is the first long-term failure mode analysis of an emerging BCI technology in a large series of non-human primates. The classification system introduced here may be used to standardize how neuroprosthetic failure modes are evaluated. The results demonstrate the potential for these arrays to record for many years, but achieving reliable sensors will require replacing connectors with implantable wireless systems, controlling the meningeal reaction, and improving insulation materials. These results will focus future research in order to create clinical neuroprosthetic sensors, as well as valuable research tools, that are able to safely provide reliable neural signals for over a decade. PMID:24216311

Failure mode analysis of silicon-based intracortical microelectrode arrays in non-human primates

NASA Astrophysics Data System (ADS)

Barrese, James C.; Rao, Naveen; Paroo, Kaivon; Triebwasser, Corey; Vargas-Irwin, Carlos; Franquemont, Lachlan; Donoghue, John P.

2013-12-01

Objective. Brain-computer interfaces (BCIs) using chronically implanted intracortical microelectrode arrays (MEAs) have the potential to restore lost function to people with disabilities if they work reliably for years. Current sensors fail to provide reliably useful signals over extended periods of time for reasons that are not clear. This study reports a comprehensive retrospective analysis from a large set of implants of a single type of intracortical MEA in a single species, with a common set of measures in order to evaluate failure modes. Approach. Since 1996, 78 silicon MEAs were implanted in 27 monkeys (Macaca mulatta). We used two approaches to find reasons for sensor failure. First, we classified the time course leading up to complete recording failure as acute (abrupt) or chronic (progressive). Second, we evaluated the quality of electrode recordings over time based on signal features and electrode impedance. Failure modes were divided into four categories: biological, material, mechanical, and unknown. Main results. Recording duration ranged from 0 to 2104 days (5.75 years), with a mean of 387 days and a median of 182 days (n = 78). Sixty-two arrays failed completely with a mean time to failure of 332 days (median = 133 days) while nine array experiments were electively terminated for experimental reasons (mean = 486 days). Seven remained active at the close of this study (mean = 753 days). Most failures (56%) occurred within a year of implantation, with acute mechanical failures the most common class (48%), largely because of connector issues (83%). Among grossly observable biological failures (24%), a progressive meningeal reaction that separated the array from the parenchyma was most prevalent (14.5%). In the absence of acute interruptions, electrode recordings showed a slow progressive decline in spike amplitude, noise amplitude, and number of viable channels that predicts complete signal loss by about eight years. Impedance measurements showed systematic early increases, which did not appear to affect recording quality, followed by a slow decline over years. The combination of slowly falling impedance and signal quality in these arrays indicates that insulating material failure is the most significant factor. Significance. This is the first long-term failure mode analysis of an emerging BCI technology in a large series of non-human primates. The classification system introduced here may be used to standardize how neuroprosthetic failure modes are evaluated. The results demonstrate the potential for these arrays to record for many years, but achieving reliable sensors will require replacing connectors with implantable wireless systems, controlling the meningeal reaction, and improving insulation materials. These results will focus future research in order to create clinical neuroprosthetic sensors, as well as valuable research tools, that are able to safely provide reliable neural signals for over a decade.

Fatigue lifetime prediction of a reduced-diameter dental implant system: Numerical and experimental study.

PubMed

Duan, Yuanyuan; Gonzalez, Jorge A; Kulkarni, Pratim A; Nagy, William W; Griggs, Jason A

2018-06-16

To validate the fatigue lifetime of a reduced-diameter dental implant system predicted by three-dimensional finite element analysis (FEA) by testing physical implant specimens using an accelerated lifetime testing (ALT) strategy with the apparatus specified by ISO 14801. A commercially-available reduced-diameter titanium dental implant system (Straumann Standard Plus NN) was digitized using a micro-CT scanner. Axial slices were processed using an interactive medical image processing software (Mimics) to create 3D models. FEA analysis was performed in ABAQUS, and fatigue lifetime was predicted using fe-safe ® software. The same implant specimens (n=15) were tested at a frequency of 2Hz on load frames using apparatus specified by ISO 14801 and ALT. Multiple step-stress load profiles with various aggressiveness were used to improve testing efficiency. Fatigue lifetime statistics of physical specimens were estimated in a reliability analysis software (ALTA PRO). Fractured specimens were examined using SEM with fractographic technique to determine the failure mode. FEA predicted lifetime was within the 95% confidence interval of lifetime estimated by experimental results, which suggested that FEA prediction was accurate for this implant system. The highest probability of failure was located at the root of the implant body screw thread adjacent to the simulated bone level, which also agreed with the failure origin in physical specimens. Fatigue lifetime predictions based on finite element modeling could yield similar results in lieu of physical testing, allowing the use of virtual testing in the early stages of future research projects on implant fatigue. Copyright © 2018 The Academy of Dental Materials. Published by Elsevier Inc. All rights reserved.

Long-term survival of donor bone marrow multipotent mesenchymal stromal cells implanted into the periosteum of patients with allogeneic graft failure.

PubMed

Kuzmina, L A; Petinati, N A; Sats, N V; Drize, N J; Risinskaya, N V; Sudarikov, A B; Vasilieva, V A; Drokov, M Y; Michalzova, E D; Parovichnikova, E N; Savchenko, V G

2016-09-01

The present study involved three patients with graft failure following allogeneic hematopoietic stem cell transplantation (allo-HSCT). We obtained multipotent mesenchymal stromal cells (MSCs) from the original hematopoietic cell donors and implanted these cells in the periosteum to treat long-term bone marrow aplasia. The results showed that in all patients endogenous blood formation was recovered 2 weeks after MSC administration. Donor MSCs were found in recipient bone marrow three and 5 months following MSC implantation. Thus, our findings indicate that functional donor MSCs can persist in patient bone marrow.

The NO Regular Defibrillation testing In Cardioverter Defibrillator Implantation (NORDIC ICD) trial: concept and design of a randomized, controlled trial of intra-operative defibrillation testing during de novo defibrillator implantation.

PubMed

Bänsch, Dietmar; Bonnemeier, Hendrik; Brandt, Johan; Bode, Frank; Svendsen, Jesper Hastrup; Felk, Angelika; Hauser, Tino; Wegscheider, Karl

2015-01-01

Although defibrillation (DF) testing is still considered a standard procedure during implantable cardioverter-defibrillator (ICD) insertion and has been an essential element of all trials that demonstrated the survival benefit of ICD therapy, there are no large randomized clinical trials demonstrating that DF testing improves clinical outcome and if the outcome would remain the same by omitting DF testing. Between February 2011 and July 2013, we randomly assigned 1077 patients to ICD implantation with (n = 540) or without (n = 537) DF testing. The intra-operative DF testing was standardized across all participating centres. After inducing a fast ventricular tachycardia (VT) with a heart rate ≥240 b.p.m. or ventricular fibrillation (VF) with a low-energy T-wave shock, DF was attempted with an initial 15 J shock. If the shock reversed the VT or VF, DF testing was considered successful and terminated. If unsuccessful, two effective 24 J shocks were administered. If DF was unsuccessful, the system was reconfigured and another DF testing was performed. An ICD shock energy of 40 J had to be programmed in all patients for treatment of spontaneous VT/VF episodes. The primary endpoint was the average efficacy of the first ICD shock for all true VT/VF episodes in each patient during follow-up. The secondary endpoints included the frequency of system revisions, total fluoroscopy, implantation time, procedural serious adverse events, and all-cause, cardiac, and arrhythmic mortality during follow-up. Home Monitoring was used in all patients to continuously monitor the system integrity, device programming and performance. The NO Regular Defibrillation testing In Cardioverter Defibrillator Implantation (NORDIC ICD) trial is one of two large prospective randomized trials assessing the effect of DF testing omission during ICD implantation. NCT01282918. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

A retrospective study of sintered porous-surfaced dental implants in restoring the edentulous posterior mandible: up to 9 years of functioning.

PubMed

Sohn, Dong-Seok; Kim, Woo-Sung; Lee, Won-Hyuk; Jung, Heui-Seung; Shin, Im-Hee

2010-10-01

The aim of this retrospective study was to evaluate the survival rate of sintered porous-surfaced implants placed in the edentulous posterior mandibles, in relation to implant length and diameter, crown-to-implant ratio, and types of prostheses, for a maximum of 9 years of functioning (mean: 55.8 months; range: 5-108 months). The study group consisted of 43 partially edentulous patients who visited Catholic University Hospital of Daegu and 1 private dental clinic. A total of 122 sintered porous-surfaced implants--Endopore (Innova Life Sciences, Toronto, Ontario, Canada)--were placed in the edentulous posterior mandibles. Two diameter sizes (4.1 and 5.0 mm) and 4 lengths (5.0, 7.0, 9.0, and 12.0 mm) were used. All implants were restored with fixed prostheses. One hundred three implants were splinted and 21 implants were nonsplinted. Panoramic views and periapical radiographs were taken at the time of the first, postoperative, crown placement, and following checkup visits. The survival rates of the implants in relation to length, diameter, crown-to-implant ratio, and types of prostheses were investigated. Statistical data were analyzed using SPSS Win.Ver 14.0 software with the χ² test. The survival rate of the 4.1-mm-diameter implants was 100% and 91.2% for the 5.0-mm-diameter implants. The survival rates of the implants of differing diameters were found to be statistically different (P = 0.005). The survival rates of both the 5.0-mm and 7.0-mm-length implants were 100%. The survival rate of the 9.0-mm-length implants was 97.9% and for the 12.0-mm-length implants was 95.1%. There was no statistical difference in survival rates for the differing lengths of implants. Of the 103 prostheses that were splinted, the survival rate was 98.0%. The survival rate of splinted prostheses was higher than that of the nonsplinted prostheses but was found to be not statistically different. There were no failed cases when the crown-to-implant ratio was <1.0. When the crown-to-implant ratio was between 1.0 and 1.4, the failure rate of the implants was 6.7%. No failure was recorded with the ratio range of 1.5 to 2.0. Relative to the crown-to-implant ratio of 1.0, the failure rates were statistically different (P = 0.048). The cumulative survival rate of the porous-surfaced implants placed in the edentulous posterior mandibles was 97.5%. Short porous-surfaced implants showed satisfactory results after a maximum of 9 years of functioning in the edentulous posterior mandibles.

Lessons learnt from early failure of a patient trial with a polymer-on-polymer resurfacing hip arthroplasty.

PubMed

Van Susante, Job L C; Verdonschot, Nico; Bom, L Paul A; Tomaszewski, Pawel; Campbell, Pat; Ebramzadeh, Edward; Schreurs, B Wim

2018-02-01

Background and purpose - Hip resurfacing (HR) is a treatment option promoted for hip arthritis in young and active patients. However, adverse reactions to metal are a concern and the search for non-metallic bearing options proceeds. We present the first clinical study performed in patients using a newly developed hydrophilic polymer-on-polymer hip resurfacing device. Patients and methods - After performing extensive hip simulator tests, biocompatibility testing and animal tests (ISO 14242-1,3; 10993-3,4,5,10,11), approval was obtained from the IRB committee to enroll 15 patients in the first clinical study in humans using this experimental polymer-on-polymer hip resurfacing device. All surgeries were done by 2 experienced hip resurfacing surgeons. Clinical scores and standard radiographs as well as routine MRIs were obtained at regular intervals. Results - The surgical technique proved feasible with successful implantation of the new device using PMMA cement fixation on both sides without complications. Postoperative imaging revealed a well-positioned and well-fixed polymer resurfacing hip arthroplasty in all 4 initial cases. All 4 patients were free of pain and had good function for the first 2 months. However, in all 4 cases early cup loosening occurred between 8 and 11 weeks after surgery, necessitating immediate closure of the study. All 4 patients had a reoperation and were revised to a conventional THA. Retrieval analyses confirmed early cup loosening at the implant-cement interface in all 4 cases. The femoral components remained well attached to the cement. The periprosthetic tissues showed only small amounts of polymeric wear debris and there was only a very mild inflammatory reaction to this. Interpretation - Early cup loosening mandated a premature arrest of this study. After additional laboratory testing this failure mode was found to be the result of a small, yet measurable contraction in the cup size after exposing these implants to biological fluid divalent ion fluctuations in vivo. Currently used preclinical tests had failed to detect this failure mechanism. Modification of the polymer is essential to overcome these problems and before the potential of a polymer-on-polymer resurfacing arthroplasty may be further evaluated in patients.

Long-Term Survival With Implantable Cardioverter-Defibrillator in Different Symptomatic Functional Classes of Heart Failure.

PubMed

Biton, Yitschak; Rosero, Spencer; Moss, Arthur; Zareba, Wojciech; Kutyifa, Valentina; Baman, Jayson; Barsheshet, Alon; McNitt, Scott; Polonsky, Bronislava; Goldenberg, Ilan

2018-03-01

The ACC/AHA/HRS (American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society) guidelines recommend implantable cardioverter-defibrillator (ICD) therapy primary prevention in all patients with severely reduced left ventricular ejection fraction (≤30%) regardless of New York Heart Association (NYHA) functional class, whereas recent European guidelines limit the indication to those with symptomatic heart failure (NYHA ≥ II). We therefore aimed to evaluate the long-term survival benefit of primary ICD therapy among postmyocardial infarction patients with and without heart failure (HF) symptoms who were enrolled in MADIT-II (Multicenter Automatic Defibrillator Implantation Trial II). We classified 1,164 MADIT-II patient groups according to the baseline NYHA class (NYHA I [n = 442], NYHA II [n = 425], and NYHA III [n = 297]); patients with NYHA IV were excluded. Multivariate Cox proportional hazards regression modeling was performed to compare the mortality reduction with ICD versus non-ICD therapy during 8 years of follow-up between the 3 NYHA groups. The median (interquartile range) follow-up time was 7.6 (3.5 to 9) years. At 8 years of follow-up, the cumulative probability of mortality in the non-ICD treatment arm was 57% for NYHA I, 57% for NYHA II, and 76% for NYHA III (p <0.001). Multivariate models demonstrated similar long-term mortality risk reduction with ICD compared with the non-ICD treatment arm regardless of HF symptoms: NYHA I (HR = 0.63, 0.46 to 0.85, p = 0.003), NYHA II (HR = 0.68, 0.50 to 0.93, p = 0.017), and NYHA III (HR = 0.68, 0.50 to 0.94, p = 0.018); p for NYHA class by treatment arm interaction >0.10. In conclusion, primary ICD therapy provides consistent long-term survival benefit among patients with previous myocardial infarction and severe left ventricular dysfunction, regardless of HF symptoms. Copyright © 2017 Elsevier Inc. All rights reserved.

Surgical management of fractured orthodontic mini- implant- a case report.

PubMed

Desai, Manthan; Jain, Anoop; Sumra, Nida

2015-01-01

The idea of absolute anchorage has always been an elusive goal for clinicians. Orthodontic mini-implants or temporary anchorage devices allow tooth movements previously thought to be impossible or difficult. Although extensive literature exists on use of temporary anchorage devices, their failures have been hardly focused upon, especially implant fracture. The following case report describes successful management of fractured orthodontic mini-implant.

Early Clinical Results of a Novel Ab Interno Gel Stent for the Surgical Treatment of Open-angle Glaucoma.

PubMed

Sheybani, Arsham; Dick, H Burkhard; Ahmed, Iqbal I K

2016-07-01

To evaluate the intraocular pressure (IOP) lowering effect of the XEN140 microfistula gel stent implant for the surgical treatment of open-angle glaucoma. Forty-nine eyes of 49 patients with an IOP>18 mm Hg and ≤35 mm Hg were studied in a prospective nonrandomized multicenter cohort trial of the surgical implantation of the XEN140 implant in patients with open-angle glaucoma. Complete success was defined as a postoperative IOP≤18 mm Hg with ≥20% reduction in IOP at 12 months without any glaucoma medications. Failure was defined as vision loss of light perceptions vision or worse, need for additional glaucoma surgery, or <20% reduction of IOP from baseline. The average age was 64.3 (28.1 to 86.9) years old. Twenty-one eyes had prior failed trabeculectomy with mitomycin C surgery. IOP at 12 months decreased from a mean of 23.1 (±4.1) mm Hg to 14.7 (±3.7) mm Hg for a 36.4% reduction in IOP from baseline. The number of patients at 12 months who achieved an IOP≤18 mm Hg and ≥20% reduction in IOP was 40 (89%). The number of patients who achieved an IOP≤18 mm Hg and ≥20% reduction in IOP without antiglaucoma medications was 18 (40%). The XEN140 gel stent lowers IOP with few complications when implanted for the surgical treatment of open-angle glaucoma.

Treatment Failure With Rhythm and Rate Control Strategies in Patients With Atrial Fibrillation and Congestive Heart Failure: An AF-CHF Substudy.

PubMed

Dyrda, Katia; Roy, Denis; Leduc, Hugues; Talajic, Mario; Stevenson, Lynne Warner; Guerra, Peter G; Andrade, Jason; Dubuc, Marc; Macle, Laurent; Thibault, Bernard; Rivard, Lena; Khairy, Paul

2015-12-01

Rate and rhythm control strategies for atrial fibrillation (AF) are not always effective or well tolerated in patients with congestive heart failure (CHF). We assessed reasons for treatment failure, associated characteristics, and effects on survival. A total of 1,376 patients enrolled in the AF-CHF trial were followed for 37  ±  19 months, 206 (15.0%) of whom failed initial therapy leading to crossover. Rhythm control was abandoned more frequently than rate control (21.0% vs. 9.1%, P < 0.0001). Crossovers from rhythm to rate control were driven by inefficacy, whereas worsening heart failure was the most common reason to crossover from rate to rhythm control. In multivariate analyses, failure of rhythm control was associated with female sex, higher serum creatinine, functional class III or IV symptoms, lack of digoxin, and oral anticoagulation. Factors independently associated with failure of rate control were paroxysmal (vs. persistent) AF, statin therapy, and presence of an implantable cardioverter-defibrillator. Crossovers were not associated with cardiovascular mortality (hazard ratio [HR] 1.11 from rhythm to rate control; 95% confidence interval [95% CI, 0.73-1.73]; P = 0.6069; HR 1.29 from rate to rhythm control; 95% CI, 0.73-2.25; P = 0.3793) or all-cause mortality (HR 1.16 from rhythm to rate control, 95% CI [0.79-1.72], P = 0.4444; HR 1.15 from rate to rhythm control, 95% [0.69, 1.91], P = 0.5873). Rhythm control is abandoned more frequently than rate control in patients with AF and CHF. The most common reasons for treatment failure are inefficacy for rhythm control and worsening heart failure for rate control. Changing strategies does not impact survival. © 2015 Wiley Periodicals, Inc.

Anterior minimally invasive approach for total hip replacement: five-year survivorship and learning curve.

PubMed

Müller, Daniel A; Zingg, Patrick O; Dora, Claudio

2014-01-01

Opponents associate minimally invasive total hip replacement (THR) with additional risks, potentially resulting in increased implant failure rates. The purpose was to document complications, quality of implant positioning and five-year survivorship of THR using the AMIS approach and to test the hypothesis that eventual high complication and revision rates would be limited to an early series and be avoided by junior surgeons who get trained by a senior surgeon. A consecutive series of 150 primary THR implanted during the introduction of the AMIS technique in the department was retrospectively analysed for complications, implant positioning and implant survival after a minimum of five years. Survivorship curves of implants were compared between different surgeons and time periods. Due to implant revision for any reason the five-year survival rate was 94.6%, 78.9% for the first 20 and 96.8% for the following 130 AMIS procedures (p = 0.001). The hazard ratio for implant failure was 0.979 indicating a risk reduction of 2% every further case. The five-year implant survivorship of those procedures performed by two junior surgeons was 97.7%. We conclude that adoption of AMIS temporarily exposed patients to a higher risk of implant revisions, which normalised after the first 20 cases and that experience from a single surgeon's learning curve could effectively be taught to junior surgeons.

The patient general satisfaction of mandibular single-implant overdentures and conventional complete dentures: Study protocol for a randomized crossover trial.

PubMed

Kanazawa, Manabu; Tanoue, Mariko; Miyayasu, Anna; Takeshita, Shin; Sato, Daisuke; Asami, Mari; Lam, Thuy Vo; Thu, Khaing Myat; Oda, Ken; Komagamine, Yuriko; Minakuchi, Shunsuke; Feine, Jocelyne

2018-05-01

Mandibular overdentures retained by a single implant placed in the midline of edentulous mandible have been reported to be more comfortable and function better than complete dentures. Although single-implant overdentures are still more costly than conventional complete dentures, there are a few studies which investigated whether mandibular single-implant overdentures are superior to complete dentures when patient general satisfaction is compared. The aim of this study is to assess patient general satisfaction with mandibular single-implant overdentures and complete dentures. This study is a randomized crossover trial to compare mandibular single-implant overdentures and complete dentures in edentulous individuals. Participant recruitment is ongoing at the time of this submission. Twenty-two participants will be recruited. New mandibular complete dentures will be fabricated. A single implant will be placed in the midline of the edentulous mandible. The mucosal surface of the complete denture around the implant will be relieved for 3 months. The participants will then be randomly allocated into 2 groups according to the order of the interventions; group 1 will receive single-implant overdentures first and will wear them for 2 months, followed by complete dentures for 2 months. Group 2 will receive the same treatments in a reverse order. After experiencing the 2 interventions, the participants will choose one of the mandibular prostheses, and yearly follow-up visits are planned for 5 years. The primary outcome of this trial is patient ratings of general satisfaction on 100 mm visual analog scales. Assessments of the prostheses and oral health-related quality of life will also be recorded as patient-reported outcomes. The secondary outcomes are cost and time for treatment. Masticatory efficiency and cognitive capacity will also be recorded. Furthermore, qualitative research will be performed to investigate the factors associated with success of these mandibular denture types. Clinical outcomes, such as implant survival rate, marginal bone loss, and prosthodontic complications, will also be recorded. The results of this randomized crossover trial will clarify whether mandibular single implants and overdentures for edentulous individuals provide better patient general satisfaction when compared to conventional complete dentures. This clinical trial was registered at the University Hospital Medical Information Network (UMIN) Center (UMIN000017883).

Imaging of common breast implants and implant-related complications: A pictorial essay

PubMed Central

Shah, Amisha T; Jankharia, Bijal B

2016-01-01

The number of women undergoing breast implant procedures is increasing exponentially. It is, therefore, imperative for a radiologist to be familiar with the normal and abnormal imaging appearances of common breast implants. Diagnostic imaging studies such as mammography, ultrasonography, and magnetic resonance imaging are used to evaluate implant integrity, detect abnormalities of the implant and its surrounding capsule, and detect breast conditions unrelated to implants. Magnetic resonance imaging of silicone breast implants, with its high sensitivity and specificity for detecting implant rupture, is the most reliable modality to asses implant integrity. Whichever imaging modality is used, the overall aim of imaging breast implants is to provide the pertinent information about implant integrity, detect implant failures, and to detect breast conditions unrelated to the implants, such as cancer. PMID:27413269

Imaging of common breast implants and implant-related complications: A pictorial essay.

PubMed

Shah, Amisha T; Jankharia, Bijal B

2016-01-01

The number of women undergoing breast implant procedures is increasing exponentially. It is, therefore, imperative for a radiologist to be familiar with the normal and abnormal imaging appearances of common breast implants. Diagnostic imaging studies such as mammography, ultrasonography, and magnetic resonance imaging are used to evaluate implant integrity, detect abnormalities of the implant and its surrounding capsule, and detect breast conditions unrelated to implants. Magnetic resonance imaging of silicone breast implants, with its high sensitivity and specificity for detecting implant rupture, is the most reliable modality to asses implant integrity. Whichever imaging modality is used, the overall aim of imaging breast implants is to provide the pertinent information about implant integrity, detect implant failures, and to detect breast conditions unrelated to the implants, such as cancer.

Angulated Dental Implants in Posterior Maxilla FEA and Experimental Verification.

PubMed

Hamed, Hamed A; Marzook, Hamdy A; Ghoneem, Nahed E; El-Anwar, Mohamed I

2018-02-15

This study aimed to evaluate the effect of different implant angulations in posterior maxilla on stress distribution by finite element analysis and verify its results experimentally. Two simplified models were prepared for an implant placed vertically and tilted 25° piercing the maxillary sinus. Geometric models' components were prepared by Autodesk Inventor then assembled in ANSYS for finite element analysis. The results of finite element analysis were verified against experimental trials results which were statistically analysed using student t-test (level of significance p < 0.05). Implant - abutment complex absorbed the load energy in case of vertical implant better than the case of angulated one. That was reflected on cortical bone stress, while both cases showed stress levels within the physiological limits. Comparing results between FEA and experiment trials showed full agreement. It was found that the tilted implant by 25° can be utilised in the posterior region maxilla for replacing maxillary first molar avoiding sinus penetration. The implant-bone interface and peri-implant bones received the highest Von Mises stress. Implant - bone interface with angulated implant received about 66% more stresses than the straight one.

Efficacy and Safety of Long-Acting Reversible Contraception

PubMed Central

Stoddard, Amy; McNicholas, Colleen; Peipert, Jeffrey F.

2013-01-01

Long-acting reversible contraception (LARC) includes intrauterine devices (IUDs) and the subdermal implant. These methods are the most effective reversible methods of contraception, and have the additional advantages of being long-lasting, convenient, well liked by users and cost effective. Compared with other user-dependent methods that increase the risk of noncompliance-related method failure, LARC methods can bring ‘typical use’ failure rates more in line with ‘perfect use’ failure rates. LARC methods are ‘forgettable’; they are not dependent on compliance with a pill-taking regimen, remembering to change a patch or ring, or coming back to the clinician for an injection. LARC method failure rates rival that of tubal sterilization at <1% for IUDs and the subdermal implant. For these reasons, we believe that IUDs and implants should be offered as first-line contraception for most women. This article provides a review of the LARC methods that are currently available in the US, including their effectiveness, advantages, disadvantages and contraindications. Additionally, we dispel myths and misconceptions regarding IUDs, and address the barriers to LARC use. PMID:21668037

The Survival of Morse Cone-Connection Implants with Platform Switch.

PubMed

Cassetta, Michele; Di Mambro, Alfonso; Giansanti, Matteo; Brandetti, Giulia

2016-01-01

The aim of this prospective clinical study was to evaluate the survival up to 5 years of Morse cone-connection implants with platform switch considering the influence of biologically relevant, anatomical, and stress-related variables. STROBE guidelines were followed. Seven hundred forty-eight implants were inserted in 350 patients. Follow-up visits were scheduled at the time of stagetwo surgery (2 months later) and at 6, 12, 24, 36, and 60 months. All implants were initially loaded with a cemented provisional acrylic restoration. The definitive metal-ceramic restorations were cemented at the 6-month follow-up. Implant cumulative survival rates (CSRs) were calculated using life table actuarial method. Survival data were also analyzed by the log-rank test and Cox regression. The statistical analysis was conducted at the patient level. P ≤ .05 was considered as an indicator of statistical significance. During the follow-up (mean: 40 months; SD: 20.27), 28 patients were considered failed (8%). The CSR and its standard error (SE) was 92% ± 2.17%. Patients with implant-supported single crowns had a CSR of 90%, whereas those with implant-supported fixed dental prostheses had a CSR of 93%. The implant diameter (P = .0399) and implant length (P = .0441) were statistically significant. The probability of failure was almost 75% lower for patients with wide rather than standard implants, 91% lower for patients with long implants, and 69% lower for patients with standard implants compared with short implants. The use of Morse cone-connection implants with platform switch is a safe and reliable treatment method. Stress-related variables influence the risk of failure confirming the importance of biomechanical factors in the longevity of osseointegrated implants; thus, the clinician may obtain better results if attention is paid to these factors.

The immediate placement of dental implants into extraction sites with periapical lesions: a retrospective chart review.

PubMed

Bell, Christopher Lincoln; Diehl, David; Bell, Brian Michael; Bell, Robert E

2011-06-01

The purpose of this study was to evaluate the success of dental implants placed immediately into extraction sites in the presence of chronic periapical pathology. The charts of 655 patients who had implants immediately placed into fresh extraction sites were reviewed for the presence or absence of periapical radiolucencies. A total of 922 implants were included. Of the 922 implants, 285 were immediately placed into sockets that had chronic periapical infections. The remaining 637 implants, without signs of periapical pathology, were used as the control group. Success of the implants was defined as successful osseointegration, successful restoration, and absence of evidence of bone loss or peri-implantitis. Other variables such as age, gender, smoking, diabetes, bisphosphonate use, lucencies of adjacent teeth, and implant stability at the time of placement were also evaluated. Of the 922 implants, 285 were placed into sockets with periapical radiolucencies. The success rate of implants placed in the study group was 97.5%, whereas the success rate of the control group was 98.7%. The difference was not found to be statistically significant. The mean follow-up was 19.75 months, with a maximum of 93 months and a minimum of 3 months. A statistically higher failure rate was found for implants placed adjacent to retained teeth with periapical pathology. The placement of implants in sockets affected by chronic periapical pathology can be considered a safe and viable treatment option. There is a risk of implant failure when placing implants adjacent to teeth with periapical radiolucencies. Copyright © 2011 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Survival of dental implants in native and grafted bone in irradiated head and neck cancer patients: a retrospective analysis.

PubMed

Buddula, Aravind; Assad, Daniel A; Salinas, Thomas J; Garces, Yolanda I

2011-01-01

To study the long-term survival of dental implants placed in native or grafted bone in irradiated bone in subjects who had received radiation for head and neck cancer. A retrospective chart review was conducted for all patients who received dental implants following radiation treatment for head and neck cancer between May 1, 1987 and July 1, 2008. Only patients irradiated with a radiation dose of 50 Gy or greater and those who received dental implants in the irradiated field after head and neck radiation were included in the study. The associations between implant survival and patient/implant characteristics were estimated by fitting univariate marginal Cox proportional hazards models. A total of 48 patients who had prior head and neck radiation had 271 dental implants placed during May 1987-July 2008. There was no statistically significant difference between implant failure in native and grafted bone (P=0.76). Survival of implants in grafted bone was 82.3% and 98.1% in maxilla and mandible, respectively, after 3 years. Survival of implants in native bone in maxilla and mandible was 79.8% and 100%, respectively, after 3 years. For implants placed in the native bone, there was a higher likelihood of failure in the maxilla compared to the mandible and there was also a tendency for implants placed in the posterior region to fail compared to those placed in the anterior region. There was no significant difference in survival when implants were placed in native or grafted bone in irradiated head and neck cancer patients. For implants placed in native bone, survival was significantly influenced by the location of the implant (maxilla or mandible, anterior or posterior).

Corrosion processes of physical vapor deposition-coated metallic implants.

PubMed

Antunes, Renato Altobelli; de Oliveira, Mara Cristina Lopes

2009-01-01

Protecting metallic implants from the harsh environment of physiological fluids is essential to guaranteeing successful long-term use in a patient's body. Chemical degradation may lead to the failure of an implant device in two different ways. First, metal ions may cause inflammatory reactions in the tissues surrounding the implant and, in extreme cases, these reactions may inflict acute pain on the patient and lead to loosening of the device. Therefore, increasing wear strength is beneficial to the performance of the metallic implant. Second, localized corrosion processes contribute to the nucleation of fatigue cracks, and corrosion fatigue is the main reason for the mechanical failure of metallic implants. Common biomedical alloys such as stainless steel, cobalt-chrome alloys, and titanium alloys are prone to at least one of these problems. Vapor-deposited hard coatings act directly to improve corrosion, wear, and fatigue resistances of metallic materials. The effectiveness of the corrosion protection is strongly related to the structure of the physical vapor deposition layer. The aim of this paper is to present a comprehensive review of the correlation between the structure of physical vapor deposition layers and the corrosion properties of metallic implants.

Failure location prediction by finite element analysis for an additive manufactured mandible implant.

PubMed

Huo, Jinxing; Dérand, Per; Rännar, Lars-Erik; Hirsch, Jan-Michaél; Gamstedt, E Kristofer

2015-09-01

In order to reconstruct a patient with a bone defect in the mandible, a porous scaffold attached to a plate, both in a titanium alloy, was designed and manufactured using additive manufacturing. Regrettably, the implant fractured in vivo several months after surgery. The aim of this study was to investigate the failure of the implant and show a way of predicting the mechanical properties of the implant before surgery. All computed tomography data of the patient were preprocessed to remove metallic artefacts with metal deletion technique before mandible geometry reconstruction. The three-dimensional geometry of the patient's mandible was also reconstructed, and the implant was fixed to the bone model with screws in Mimics medical imaging software. A finite element model was established from the assembly of the mandible and the implant to study stresses developed during mastication. The stress distribution in the load-bearing plate was computed, and the location of main stress concentration in the plate was determined. Comparison between the fracture region and the location of the stress concentration shows that finite element analysis could serve as a tool for optimizing the design of mandible implants. Copyright © 2015 IPEM. Published by Elsevier Ltd. All rights reserved.

Durability of implanted electrodes and leads in an upper-limb neuroprosthesis.

PubMed

Kilgore, Kevin L; Peckham, P Hunter; Keith, Michael W; Montague, Fred W; Hart, Ronald L; Gazdik, Martha M; Bryden, Anne M; Snyder, Scott A; Stage, Thomas G

2003-01-01

Implanted neuroprosthetic systems have been successfully used to provide upper-limb function for over 16 years. A critical aspect of these implanted systems is the safety, stability, and-reliability of the stimulating electrodes and leads. These components are (1) the stimulating electrode itself, (2) the electrode lead, and (3) the lead-to-device connector. A failure in any of these components causes the direct loss of the capability to activate a muscle consistently, usually resulting in a decrement in the function provided by the neuroprosthesis. Our results indicate that the electrode, lead, and connector system are extremely durable. We analyzed 238 electrodes that have been implanted as part of an upper-limb neuroprosthesis. Each electrode had been implanted at least 3 years, with a maximum implantation time of over 16 years. Only three electrode-lead failures and one electrode infection occurred, for a survival rate of almost 99 percent. Electrode threshold measurements indicate that the electrode response is stable over time, with no evidence of electrode migration or continual encapsulation in any of the electrodes studied. These results have an impact on the design of implantable neuroprosthetic systems. The electrode-lead component of these systems should no longer be considered a weak technological link.

Budget impact analysis of 8 hormonal contraceptive options.

PubMed

Crespi, Simone; Kerrigan, Matthew; Sood, Vipan

2013-07-01

To develop a model comparing costs of 8 hormonal contraceptives and determine whether acquisition costs for implants and intrauterine devices (IUDs) were offset by decreased pregnancy-related costs over a 3-year time horizon from a managed care perspective. A model was developed to assess the budget impact of branded or generic oral contraceptives (OCs), quarterly intramuscular depot medroxyprogesterone, etonogestrel/ethinyl estradiol vaginal ring, etonogestrel implant, levonorgestrel IUD, norelgestromin/ethinyl estradiol transdermal contraceptive, and ethinyl estradiol/levonorgestrel extended-cycle OC. Major variables included drug costs, typical use failure rates, discontinuation rates, and pregnancy costs. The base case assessed costs for 1000 women initiating each of the hormonal contraceptives. The etonogestrel implant and levonorgestrel IUD resulted in the fewest pregnancies, 63 and 85, respectively, and the least cost, $1.75 million and $2.0 million, respectively. In comparison, generic OC users accounted for a total of 243 pregnancies and $3.4 million in costs. At the end of year 1, costs for the etonogestrel implant ($800,471) and levonorgestrel IUD ($949,721) were already lower than those for generic OCs ($1,146,890). Sensitivity analysis showed that the cost of pregnancies, not product acquisition cost, was the primary cost driver. Higher initial acquisition costs for the etonogestrel implant and levonorgestrel IUD were offset within 1 year by lower contraceptive failure rates and consequent pregnancy costs. Thus, after accounting for typical use failure rates of contraceptive products, the etonogestrel implant and levonorgestrel IUD emerged as the least expensive hormonal contraceptives.

Outcomes of Minimally Invasive Temporary Right Ventricular Assist Device Support for Acute Right Ventricular Failure During Minimally Invasive Left Ventricular Assist Device Implantation.

PubMed

Schaefer, Andreas; Reichart, Daniel; Bernhardt, Alexander M; Kubik, Mathias; Barten, Markus J; Wagner, Florian M; Reichenspurner, Hermann; Philipp, Sebastian A; Deuse, Tobias

Right ventricular failure (RVF) may still occur despite the benefits of minimally invasive left ventricular assist device (MI-LVAD) implantation. Our center strategy aims to avoid aggressive postoperative inotrope use by using mechanical support to facilitate right ventricle recovery and adaptation. We herein report first outcomes of patients with minimally invasive temporary right ventricular assist device (MI-t-RVAD) support for RVF during MI-LVAD implantation. Right ventricular failure was defined as requiring more than moderate inotopic support after weaning from cardiopulmonary bypass according to Interagency Registry for Mechanically Assisted Circulatory Support adverse event definitions. All patients requiring MI-t-RVAD support for RVF during MI-LVAD implantation between January, 2012 and April, 2016 were retrospectively reviewed. Clinical endpoints were death or unsuccessful RVAD weaning. Overall 10 patients (90% male, mean age 49.6 ± 14.8 years) underwent MI-t-RVAD implantation. Duration of MI-t-RVAD support was 16.2 ± 11.6 days. Right ventricular assist device weaning and subsequent uneventful awake device explantation was successful in all cases. The 30 day survival was 80%. Our results confirm safety and feasibility of MI-t-RVAD support for acute RVF in the setting of MI-LVAD implantation. The potential benefits of this strategy are more stable hemodynamics in the first postoperative days that usually are crucial for LVAD patients and reduced inotrope requirement.

In Vitro Measurement Of Insertion Torque, Removal Torque And Resonance Frequency Analysis Of Implants Placed Into Simulated Bony Defects

DTIC Science & Technology

2014-05-14

2002). "Healing after standardized clinical probing of perlimlant soft tissue seal; a histomorphometric study in dogs." Clinical oral Implants...implant and periodontal tissues . A study in the beagle dog." Clin Oral Implants Res3(1): 9-16. Luterbacher, S., Mayfield, L. (2000). "Diagnostic...encapsulation around the implant and soft tissue . This type of healing and encapsulation led to inflammation, infection, mobility and failure of the

Failures and complications in patients with birth defects restored with fixed dental prostheses and single crowns on teeth and/or implants.

PubMed

Krieger, Oliver; Matuliene, Giedre; Hüsler, Jürg; Salvi, Giovanni E; Pjetursson, Bjarni; Brägger, Urs

2009-08-01

To assess retrospectively, over at least 5 years, the incidences of technical and biological complications and failures in young adult patients with birth defects affecting the formation of teeth. All insurance cases with a birth defect that had crowns and fixed dental prostheses (FDPs) inserted more than 5 years ago were contacted and asked to participate in a reexamination. The median age of the patients was 19.3 years (range 16.6-24.7 years) when prosthetic treatment was initiated. Over the median observation period of 15.7 years (range 7.4-24.9 years) and considering the treatment needs at the reexamination, 19 out of 33 patients (58%) with reconstructions on teeth remained free from all failures or complications. From the patients with FDPs and single unit crowns (SCs) on implants followed over a median observation period of 8 years (range 4.6-15.3 years), eight out of 17% or 47% needed a retreatment or repair at some point due to a failure or a complication. From the three groups of patients, the cases with amelogenesis/dentinogenesis imperfecta demonstrated the highest failure and complication rates. In the cases with cleft lip, alveolus and palate (CLAP) or hypodontia/oligodontia, 71% of the SCs and 73% of the FDPs on teeth (FDP T) remained complication free over a median observation period of about 16 years. Sixty-two percent of the SCs and 64% of the FDPs on implants remained complication free over 8 years. Complications occurred earlier with implant-supported reconstructions. Because healthy, pristine teeth can be left unprepared, implant-supported SCs and FDPs are the treatment choice in young adults with birth defects resulting in tooth agenesis and in whom the edentulous spaces cannot be closed by means of orthodontic therapy. However, the trend for earlier and more frequent complications with implant-supported reconstructions in young adults, expecting many years of function with the reconstructions, has to be weighed against the benefits of keeping teeth unprepared. In cases with CLAP in which anatomical conditions render implant placement difficult and in which teeth adjacent to the cleft require esthetic corrections, the conventional FDP T still remains the treatment of choice.

In vitro comparison of implant- versus gingiva-supported removable dentures in anterior and posterior applications.

PubMed

Rosentritt, Martin; Heidtkamp, Felix; Hösl, Helmut; Hahnel, Sebastian; Preis, Verena

2016-03-01

Removable dentures with different denture teeth may provide different performance and resistance in implant and gingival situations, or anterior and posterior applications. Two situations of removable dentures were investigated: gingiva (flexible) and implant (rigid) bearing. For simulating the gingiva/jaw situation, the dentures were supported with flexible lining material. For the implant situation, implants (d = 4.1 mm) were screwed into polymethylenmethacrylate (PMMA) resin. Two commercial (Vita-Physiodens MRP, SR Vivodent/Orthotyp DCL) and two experimental materials (EXP1, EXP2) were investigated in anterior (A) and posterior (P) tooth locations. Chewing simulation was performed, and failures were analyzed (microscopy, SEM). Fracture strength of surviving dentures was determined. Only EXP1 revealed failures during chewing simulation. Failures varied between anterior and posterior locations, and between implant (P:4x; A:7x) or gingiva (P:1x; A:2x) situations. Kaplan-Meier log-rank test revealed significant differences for implant situations (p < 0.002), but not for gingiva bearing (p > 0.093). Fracture testing in the implant situation provided significantly highest values for EXP2 (1476.4 ± 532.2 N) in posterior location, and for DCL (1575.4 ± 264.4 N) and EXP2 (1797.0 ± 604.2 N) in anterior location. For gingival bearing, significantly highest values were found for DCL/P (2148.3 ± 836.3 N), and significantly lowest results for EXP1/A (308.2 ± 115.6 N). For EXP1 + EXP2 + Vita/P and for EXP1/A no significant differences were found between implant- or gingiva-supported situations. Anterior and posterior teeth showed different material-dependent in vitro performance, further influenced by implant/gingiva bearing. While an implant in anterior application increased fracture strength of two materials, it decreased fracture values of 3/4 of the materials in posterior application. Survival of denture teeth may be influenced by material, oral position, and bearing situation.

Clavicle anatomical osteosynthesis plate breakage - failure analysis report based on patient morphological parameters.

PubMed

Marinescu, Rodica; Antoniac, Vasile Iulian; Stoia, Dan Ioan; Lăptoiu, Dan Constantin

2017-01-01

Clavicle fracture reported incidence is about 5% of fractures in adult; among them, those located in the middle third of the shaft represent more than 80% from the total of cases. Due to the special morphological and biomechanical constraints of the clavicle, several methods for restoring morphological integrity in these fractures are described, including conservative, non-surgical treatment. The last 10 years of clinical studies in the field have favored the surgical treatment for selected cases; several osteosynthesis implants are in use - mostly anatomical plates with specific advantages and documented complications. A failed anatomical clavicle plate was explanted and analyzed after a protocol using stereomicroscopy, scanning electron microscopy and energy dispersive spectrometry. Based on the computed tomography (CT) scan determination of patient morphological parameters, a finite elements analysis of the failure scenario was completed. The failure analysis has proved that the plate breakage had occurred in the point of maximal elastic stress and minor deformation. The clinical implication is that no hole should remain free of screw during clavicle plate fixation and the implant should be chosen based on patient morphological parameters. In comminuted clavicle fracture, anatomic bridging with locked plate technique may lead to implant failure due to increase of the stress in the midshaft area. Thorough knowledge of anatomy and morphology of complex bones like the clavicle is necessary. Modern osteosynthesis anatomical implants are still to be improved.

[Sport for pacemaker patients].

PubMed

Israel, C W

2012-06-01

Sport activity is an important issue in many patients with a pacemaker either because they performed sport activities before pacemaker implantation to reduce the cardiovascular risk or to improve the course of an underlying cardiovascular disease (e.g. coronary artery disease, heart failure) by sports. Compared to patients with an implantable cardioverter defibrillator (ICD) the risks from underlying cardiovascular disease (e.g. ischemia, heart failure), arrhythmia, lead dysfunction or inappropriate therapy are less important or absent. Sport is contraindicated in dyspnea at rest, acute heart failure, new complex arrhythmia, acute myocarditis and acute myocardial infarction, valvular disease with indications for intervention and surgery and comorbidities which prevent physical activity. Patients with underlying cardiovascular disease (including hypertension) should preferably perform types and levels of physical activity that are aerobic (with dynamic exercise) such as running, swimming, cycling instead of sport with high anaerobic demands and high muscular workload. In heart failure, studies demonstrated advantages of isometric sport that increases the amount of muscle, thereby preventing cardiac cachexia. Sport with a risk of blows to the chest or physical contact (e.g. boxing, rugby, martial arts) should be avoided. Implantation, programming and follow-up should respect specific precautions to allow optimal physical activity with a pacemaker including implantation of bipolar leads on the side contralateral to the dominant hand, individual programming of the upper sensor and tracking rate and regular exercise testing.

The Future of Adult Cardiac Assist Devices: Novel Systems and Mechanical Circulatory Support Strategies

PubMed Central

Bartoli, Carlo R.; Dowling, Robert D.

2011-01-01

Synopsis The recent, widespread success of mechanical circulatory support has ushered in a new era of cardiovascular medicine in which numerous implantable devices exist to treat advanced heart failure. As cardiac assist devices gain prevalence in the clinical management of cardiovascular disease, it is increasingly important to raise awareness of novel device systems, the unique mechanisms by which they function, and implications for patient management. In this article, we present state-of-the-art devices that are currently under development or in clinical trials. Devices are categorized as Standard Full-Support (HeartMate III, CorAide, Evaheart LVAS), Less-Invasive Full-Support (MVAD), Partial-Support (CircuLite Synergy Pocket Micro-Pump, Reitan Catheter Pump, Procyrion CAD, C-Pulse, Symphony Counterpulsation Device) Right Ventricular Assist Device (RVAD; DexAide, Impella RD Recover, Impella RP), and Total Artificial Heart (TAH; CardioWest, AbioCor II, Continuous-Flow TAH, Continuous-Flow BiVAD). Implantation strategy, mechanism of action, durability, efficacy, hemocompatibility, and human factors such as quality of life during device support are considered. The feasibility of novel strategies for unloading the failing heart is examined. PMID:22062206

Remote Monitoring for Follow-up of Patients with Cardiac Implantable Electronic Devices

PubMed Central

Morichelli, Loredana; Varma, Niraj

2014-01-01

Follow-up of patients with cardiac implantable electronic devices is challenging due to the increasing number and technical complexity of devices coupled to increasing clinical complexity of patients. Remote monitoring (RM) offers the opportunity to optimise clinic workflow and to improve device monitoring and patient management. Several randomised clinical trials and registries have demonstrated that RM may reduce number of hospital visits, time required for patient follow-up, physician and nurse time, hospital and social costs. Furthermore, patient retention and adherence to follow-up schedule are significantly improved by RM. Continuous wireless monitoring of data stored in the device memory with automatic alerts allows early detection of device malfunctions and of events requiring clinical reaction, such as atrial fibrillation, ventricular arrhythmias and heart failure. Early reaction may improve patient outcome. RM is easy to use and patients showed a high level of acceptance and satisfaction. Implementing RM in daily practice may require changes in clinic workflow. To this purpose, new organisational models have been introduced. In spite of a favourable cost:benefit ratio, RM reimbursement still represents an issue in several European countries. PMID:26835079

Number of implants for mandibular implant overdentures: a systematic review

PubMed Central

Lee, Jeong-Yol; Kim, Ha-Young; Bryant, S. Ross

2012-01-01

PURPOSE The aim of this systematic review is to address treatment outcomes of Mandibular implant overdentures relative to implant survival rate, maintenance and complications, and patient satisfaction. MATERIALS AND METHODS A systematic literature search was conducted by a PubMed search strategy and hand-searching of relevant journals from included studies. Randomized Clinical Trials (RCT) and comparative clinical trial studies on mandibular implant overdentures until August, 2010 were selected. Eleven studies from 1098 studies were finally selected and data were analyzed relative to number of implants. RESULTS Six studies presented the data of the implant survival rate which ranged from 95% to 100% for 2 and 4 implant group and from 81.8% to 96.1% for 1 and 2 implant group. One study, which statistically compared implant survival rate showed no significant differences relative to the number of implants. The most common type of prosthetic maintenance and complications were replacement or reattaching of loose clips for 2 and 4 implant group, and denture repair due to the fracture around an implant for 1 and 2 implant groups. Most studies showed no significant differences in the rate of prosthetic maintenance and complication, and patient satisfaction regardless the number of implants. CONCLUSION The implant survival rate of mandibular overdentures is high regardless of the number of implants. Denture maintenance is likely not inflenced substantially by the number of implants and patient satisfaction is typically high again regardless os the number of implants. PMID:23236572

Impact of graft implantation order on graft survival in simultaneous pancreas-kidney transplantation.

PubMed

Niclauss, Nadja; Bédat, Benoît; Morel, Philippe; Andres, Axel; Toso, Christian; Berney, Thierry

2016-05-01

The optimal order of revascularization for pancreas and kidney grafts in simultaneous pancreas-kidney transplantation has not been established. In this study, we investigate the influence of graft implantation order on graft survival in SPK. 12 700 transplantations from the Scientific Registry of Transplant Recipients were analyzed retrospectively. Graft implantation order was determined based on the reported ischemia times of pancreas and kidney grafts. Pancreas and kidney graft survivals were analyzed depending on graft implantation order at 3 months and 5 years using Kaplan-Meier plots. Significance was tested with log-rank test and Cox regression model. In 8454 transplantations, the pancreas was implanted first (PBK), and in 4246 transplantations, the kidney was implanted first (KBP). The proportion of lost pancreas grafts at 3 months was significantly lower in PBK (9.4% vs. 10.8%, P = 0.011). Increasing time lag (>2 h) between kidney and pancreas graft implantation in KBP accentuated the detrimental impact on pancreas graft survival (12.5% graft loss at 3 months, P = 0.001). Technical failure rates were reduced in PBK (5.6 vs. 6.9%, P = 0.005). Graft implantation order had no impact on kidney graft survival. In summary, although observed differences are small, pancreas graft implantation first increases short-term pancreas graft survival and reduces rates of technical failure. © 2016 Steunstichting ESOT.

Evaluation of XIENCE V everolimus-eluting and Taxus Express2 paclitaxel-eluting coronary stents in patients with jailed side branches from the SPIRIT IV trial at 2 years.

PubMed

Forrest, John K; Lansky, Alexandra J; Meller, Stephanie M; Hou, Liming; Sood, Poornima; Applegate, Robert J; Wang, John C; Skelding, Kimberly A; Shah, Aakar; Kereiakes, Dean J; Sudhir, Krishnankutty; Cristea, Ecaterina; Yaqub, Manejeh; Stone, Gregg W

2013-06-01

The aim of this study was to determine whether patients from the Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions (SPIRIT) IV trial who underwent percutaneous coronary intervention, who had target lesions with jailed side branches, had improved clinical outcomes when treated with the XIENCE V versus Taxus Express(2) drug-eluting stent. In the SPIRIT III randomized trial, patients with target lesions with jailed side branches after XIENCE V compared with Taxus Express(2) implantation had lower 2-year rates of major adverse cardiac events. The SPIRIT IV trial represents a larger more diverse patient population compared with SPIRIT III. In the large-scale, prospective, multicenter, randomized SPIRIT IV trial, 3,687 patients who underwent coronary stenting with up to 3 de novo native coronary artery lesions were randomized 2:1 to receive XIENCE V versus Taxus Express(2) stents. Two-year clinical outcomes of patients with or without jailed side branches after stenting were compared. A jailed side branch was defined as any side branch >1.0 mm in diameter within the target segment being stented, excluding bifurcations deemed to require treatment. Of the 3,687 patients in SPIRIT IV, a total of 1,426 had side branches that were jailed during angioplasty of the target lesion. Patients with jailed side branches after XIENCE V compared with Taxus Express(2) implantation had significantly lower 2-year rates of target lesion failure (6.5% vs 11.9%, p = 0.001), major adverse cardiac events (6.6% vs 12.2%, p = 0.0008), ischemia-driven target vessel revascularization (4.1% vs 7.9%, p = 0.004), and stent thrombosis (0.6% vs 2.8%, p = 0.001). In conclusion, patients with jailed side branches after stenting with XIENCE V compared to Taxus Express(2) devices had superior clinical outcomes at 2 years in the large-scale randomized SPIRIT IV trial. Copyright © 2013 Elsevier Inc. All rights reserved.

Total artificial heart implantation in a young Marfan syndrome patient.

PubMed

Rao, Prashant; Keenan, Jack B; Rajab, Taufiek K; Kim, Samuel; Smith, Richard; Amabile, Orazio; Khalpey, Zain

2018-03-01

Cardiovascular complications represent the leading cause of morbidity and mortality in patients with Marfan syndrome. Here, we describe a unique case where a total artificial heart was implanted in a young Marfan syndrome woman. A 22-year-old postpartum African American female with Marfan syndrome developed multiple severe valve dysfunction and biventricular failure that was refractory to medical management. She previously had a Bentall procedure for Type A aortic dissection and repair of a Type B dissection. We implanted a total artificial heart with a good outcome. Total artificial heart is a durable option for severe biventricular failure and multiple valvular dysfunction as a bridge to transplant in a young patient with Marfan syndrome.

Complications with the MICRA TPS Pacemaker System: Persistent Complete Heart Block and Late Capture Failure.

PubMed

Holm, Niels; Müller, Andreas; Zbinden, Rainer

2017-04-01

A Medtronic MICRA transcatheter pacing system (Medtronic, Minneapolis, MN, USA) was implanted in an 86-year-old patient with sick sinus syndrome and left bundle branch block after transfemoral aortic valve implantation. During implantation she developed a persistent complete heart block due to manipulation with the large-bore delivery catheter. Two weeks later, acute pacemaker dysfunction occurred due to massive increase of pacing threshold and impedance without obvious pacemaker dislocation or myocardial perforation. Recurrent capture failure was seen with pacing output set at 5 V/1.0 ms. Hence, microdislocation or fixation of the tines in the right ventricular trabeculae has to be assumed. © 2016 Wiley Periodicals, Inc.

Immediate loading of implants placed in patients with untreated periodontal disease: a 5-year prospective cohort study.

PubMed

Maló, Paulo; Nobre, Miguel de Araújo; Lopes, Armando; Ferro, Ana; Gravito, Inês

2014-01-01

To report the 5-year outcome of immediately loaded dental implants in patients with untreated periodontal disease. This prospective cohort study included 103 consecutive patients (51 females and 52 males) with an average age of 52 years (range: 22 to 80 years) who were rehabilitated with 380 implants supporting 145 prostheses in both jaws (40 single; 33 partial and 72 complete rehabilitations). The implants were inserted in patients with active and untreated periodontitis. The patients did not receive any previous periodontal treatment before implant surgery, except for an oral hygiene session immediately before the implant surgery. In maintenance (every 6 months) patients received periodontal treatment as needed. Outcome measures were: prostheses failures; implant failures; complications; and marginal bone level changes. Fifteen patients dropped out of the study (14.6%). Two patients lost two implants (FDI positions nos.12 and 42), rendering a cumulative survival rate of 97.9% and 99.4% at 5 years of followup using the patient and implant as unit of analysis, respectively. The average (standard deviation) marginal bone resorption was 0.71 mm (0.42 mm) at 5 years. Mechanical complications occurred in 14 patients, consisting of prostheses fractures (10 provisional prostheses and 4 definitive prostheses). Thirteen implants (3.9%) in 13 patients (14.8%) presented peri-implant pathology. Within the limitations of this study, it is possible to conclude that the rehabilitation of patients with untreated periodontitis using immediately loaded dental implants is feasible in the medium-term, when periodontal therapy is provided after rehabilitation and the patients are regularly maintained.

Hormonal crosstalk with calcium channel blocker during implantation.

PubMed

Banerjee, Aryamitra; Padh, Harish; Nivsarkar, Manish

2011-08-01

The site specific action of the calcium channel blocker diltiazem in blocking prostaglandin synthesis and hence causing blastocyst implantation failure has been previously described. Based on this understanding it was important to learn if this pathway was under the control of the fine balance in estradiol-progesterone (E2-P4) milieu, considered to be of the utmost significance for effective implantation. In the current study the circulating E2-P4 levels were monitored on the first 6 d of pregnancy at various time points using sensitive chemiluminescence based assays. Next, diltiazem was administered intra-luminally into the uterus at 10-20 h prior to implantation as this time has been previously implicated to be when the best anti-implantation activity of diltiazem can be observed. Following this, the E2-P4 in peripheral circulation was again monitored. On d 6 (post implantation) the implantation sites were observed in the uterus of both diltiazem treated and untreated groups using Chicago blue dye and correlated to the hormonal activity. The levels of both estradiol and progesterone were very similar in both untreated and diltiazem treated groups during and post implantation. However complete implantation failure was noted in the diltiazem treated group whereas prominent implantation sites were observed in the untreated animals. Thus, the previously reported inhibition of blastocyst implantation cascade by calcium channel blockers during the 'implantation window' seems to be an independent mechanism interfering with uterine receptivity without any direct estrogen-progesterone control and further studies to understand its regulation need to be performed.

Randomized multicenter comparison of 2 IMZ and 4 TPS screw implants supporting bar-retained overdentures in 425 edentulous mandibles.

PubMed

Mau, Jochen; Behneke, Alexandra; Behneke, Nikolaus; Fritzemeier, Claus Udo; Gomez-Roman, German; d'Hoedt, Bernd; Spiekermann, Hubertus; Strunz, Volker; Yong, Mei

2003-01-01

Two treatment concepts for implant-supported bar retention of mandibular overdentures-2 intramobile cylinder (IMZ) implants and a Dolder bar and 4 titanium plasma-sprayed (TPS) screw implants and an angulated bar-were compared in a randomized controlled clinical trial with respect to postprosthetic efficacy and safety. Four hundred twenty-five patients with edentulous mandibles were enrolled; 212 were randomized to TPS implants (control group) and 213 to IMZ implants (test group). Endpoints were occurrences of postprosthetic integration deficiency (ID), functional deficiency (FD), and complications. The trial was sized to detect a 10% difference in 5-year ID-free postprosthetic system lifetime with a power of 80%. With 340 protocol-completed cases, the trial achieved its predetermined power. The 2 systems did not show statistically significant differences in occurrences of postprosthetic ID and FD; 5-year occurrence-free postprosthetic system lifetime probabilities were estimated as 42.5% with IMZ and 42.8% with TPS, for ID; and as 82.6% with IMZ and 87.2% with TPS, for FD. However, at 3 to 6 months after surgery, mean Periotest values were significantly higher (P = .0001 without adjustment) with IMZ implants (5.6, SD 4.2) than with TPS implants (0.8, SD 4.3). TPS implants showed a higher incidence of inflammation and recession, while IMZ implants had a higher incidence of implant fracture after functional loading. The system-wise approach overcomes potential bias with implant-wise analyses. A combination of radiographic and clinical criteria distinguishes between desirable integration and functional anchorage. The in situ survival rates at 5 years in this study (95% for IMZ, 92% for TPS) match rates reported in the literature. This study demonstrated equivalent efficacy of 2 IMZ cylinders and 4 TPS screws in implant-supported, bar-retained mandibular overdentures and indicated a higher rate of complications with the TPS screw implants.

Tinnitus after Simultaneous and Sequential Bilateral Cochlear Implantation.

PubMed

Ramakers, Geerte G J; Kraaijenga, Véronique J C; Smulders, Yvette E; van Zon, Alice; Stegeman, Inge; Stokroos, Robert J; Free, Rolien H; Frijns, Johan H M; Huinck, Wendy J; Van Zanten, Gijsbert A; Grolman, Wilko

2017-01-01

There is an ongoing global discussion on whether or not bilateral cochlear implantation should be standard care for bilateral deafness. Contrary to unilateral cochlear implantation, however, little is known about the effect of bilateral cochlear implantation on tinnitus. To investigate tinnitus outcomes 1 year after bilateral cochlear implantation. Secondarily, to compare tinnitus outcomes between simultaneous and sequential bilateral cochlear implantation and to investigate long-term follow-up (3 years). This study is a secondary analysis as part of a multicenter randomized controlled trial. Thirty-eight postlingually deafened adults were included in the original trial, in which the presence of tinnitus was not an inclusion criterion. All participants received cochlear implants (CIs) because of profound hearing loss. Nineteen participants received bilateral CIs simultaneously and 19 participants received bilateral CIs sequentially with an inter-implant interval of 2 years. The prevalence and severity of tinnitus before and after simultaneous and sequential bilateral cochlear implantation were measured preoperatively and each year after implantation with the Tinnitus Handicap Inventory (THI) and Tinnitus Questionnaire (TQ). The prevalence of preoperative tinnitus was 42% (16/38). One year after bilateral implantation, there was a median difference of -8 (inter-quartile range (IQR): -28 to 4) in THI score and -9 (IQR: -17 to -9) in TQ score in the participants with preoperative tinnitus. Induction of tinnitus occurred in five participants, all in the simultaneous group, in the year after bilateral implantation. Although the preoperative and also the postoperative median THI and TQ scores were higher in the simultaneous group, the median difference scores were equal in both groups. In the simultaneous group, tinnitus scores fluctuated in the 3 years after implantation. In the sequential group, four patients had an additional benefit of the second CI: a total suppression of tinnitus compared with their unilateral situation. While bilateral cochlear implantation can have a positive effect on preoperative tinnitus complaints, the induction of (temporary or permanent) tinnitus was also reported. Dutch Trial Register NTR1722.

Soft tissues healing at immediate transmucosal implants placed into molar extraction sites with buccal self-contained dehiscences. A 12-month controlled clinical trial.

PubMed

Siciliano, V Iorio; Salvi, G E; Matarasso, S; Cafiero, C; Blasi, A; Lang, N P

2009-05-01

To assess soft tissues healing at immediate transmucosal implants placed into molar extraction sites with buccal self-contained dehiscences. For this 12-month controlled clinical trial, 15 subjects received immediate transmucosal tapered-effect (TE) implants placed in molar extraction sockets displaying a buccal bone dehiscence (test sites) with a height and a width of > or =3 mm, respectively. Peri-implant marginal defects were treated according to the principles of Guided Bone Regeneration (GBR) by means of deproteinized bovine bone mineral particles in conjunction with a bioresorbable collagen membrane. Fifteen subjects received implants in healed molar sites (control sites) with intact buccal alveolar walls following tooth extraction. In total, 30 TE implants with an endosseous diameter of 4.8 mm and a shoulder diameter of 6.5 mm were used. Flaps were repositioned and sutured, allowing non-submerged, transmucosal soft tissues healing. At the 12-month follow-up, pocket probing depths (PPD) and clinical attachment levels (CAL) were compared between implants placed in the test and the control sites, respectively. All subjects completed the 12-month follow-up period. All implants healed uneventfully, yielding a survival rate of 100%. After 12 months, statistically significantly higher (P<0.05) PPD and CAL values were recorded around implants placed in the test sites compared with those placed in the control sites. The findings of this controlled clinical trial showed that healing following immediate transmucosal implant installation in molar extraction sites with wide and shallow buccal dehiscences yielded less favorable outcomes compared with those of implants placed in healed sites, and resulted in lack of 'complete' osseointegration.

Right Ventricular Failure Post LVAD Implantation Corrected with Biventricular Support: An In Vitro Model.

PubMed

Shehab, Sajad; Allida, Sabine M; Davidson, Patricia M; Newton, Phillip J; Robson, Desiree; Jansz, Paul C; Hayward, Christopher S

Right ventricular failure after left ventricular assist device (LVAD) implantation is associated with high mortality. Management remains limited to pharmacologic therapy and temporary mechanical support. Delayed right ventricular assist device (RVAD) support after LVAD implantation is associated with poorer outcomes. With the advent of miniaturized, durable, continuous flow ventricular assist device systems, chronic RVAD and biventricular assist device (BiVAD) support has been used with some success. The purpose of this study was to assess combined BiVAD and LVAD with delayed RVAD support within a four-elemental mock circulatory loop (MCL) simulating the human cardiovascular system. Our hypothesis was that delayed continuous flow RVAD (RVAD) would produce similar hemodynamic and flow parameters to those of initial BiVAD support. Using the MCL, baseline biventricular heart failure with elevated right and left filling pressures with low cardiac output was simulated. The addition of LVAD within a biventricular configuration improved cardiac output somewhat, but was associated with persistent right heart failure with elevated right-sided filling pressures. The addition of an RVAD significantly improved LVAD outputs and returned filling pressures to normal throughout the circulation. In conclusion, RVAD support successfully restored hemodynamics and flow parameters of biventricular failure supported with isolated LVAD with persistent elevated right atrial pressure.

The effect of in situ augmentation on implant anchorage in proximal humeral head fractures.

PubMed

Unger, Stefan; Erhart, Stefanie; Kralinger, Franz; Blauth, Michael; Schmoelz, Werner

2012-10-01

Fracture fixation in patients suffering from osteoporosis is difficult as sufficient implant anchorage is not always possible. One method to enhance implant anchorage is implant/screw augmentation with PMMA-cement. The present study investigated the feasibility of implant augmentation with PMMA-cement to enhance implant anchorage in the proximal humerus. A simulated three part humeral head fracture was stabilised with an angular stable plating system in 12 pairs of humeri using six head screws. In the augmentation group the proximal four screws were treated with four cannulated screws, each augmented with 0.5ml of PMMA-cement, whereas the contra lateral side served as a non-augmented control. Specimens were loaded in varus-bending or axial-rotation using a cyclic loading protocol with increasing load magnitude until failure of the osteosynthesis occurred. Augmented specimens showed a significant higher number of load cycles until failure than non-augment specimens (varus-bending: 8516 (SD 951.6) vs. 5583 (SD 2273.6), P=0.014; axial-rotation: 3316 (SD 348.8) vs. 2050 (SD 656.5), P=0.003). Non-augmented specimens showed a positive correlation of load cycles until failure and measured bone mineral density (varus-bending: r=0.893, P=0.016; axial-rotation: r=0.753, P=0.084), whereas no correlation was present in augmented specimens (varus-bending: r=0,258, P=0.621; axial-rotation r=0.127, P=0.810). These findings suggest that augmentation of cannulated screws is a feasible method to enhance implant/screw anchorage in the humeral head. The improvement of screw purchase is increasing with decreasing bone mineral density. Copyright © 2012 Elsevier Ltd. All rights reserved.

Comparison between vestibular and subcutaneous insertion of deslorelin implants for oestrus induction in bitches.

PubMed

Kutzler, M; Lamb, S V; Volkmann, D

2009-07-01

Investigations using sustained-release deslorelin implants at various insertion sites have shown that this method consistently induces oestrus in anoestus bitches. However, fertility comparisons between implant insertion sites have not been performed. Anestrous beagle bitches received one 2.1 mg deslorelin implant beneath the vestibular mucosa (VM group; n = 6) or in the subcutaneous tissue between the shoulder blades (SubQ group; n = 8). Vestibular implants were removed when serum progesterone concentrations first exceeded 1.5 ng/ml. Vaginal cytologies and blood samples were collected daily and bitches were inseminated during oestrus. Serum progesterone and deslorelin concentrations were measured and pregnancy status was determined using ultrasonography. There were no differences between groups in the intervals between implant administration and the onset of proestrus, the time of the luteinizing hormone surge and the onset of cytologic diestrus. There were also no differences in the number of corpora lutea or foetuses. However, conception rate was significantly lower in the SubQ group. The pregnancy rate did not differ significantly between the VM and SubQ groups [4 out of 6 (66.7%) and 3 out of 8 (37.5%), respectively]. One bitch (16.7%) in the VM group and three bitches (37.5%) in the SubQ group suffered distinct, premature declines in serum progesterone concentrations starting 1-4 weeks after cytologic diestrus. Serum progesterone concentrations did not recover (premature luteal failure), resulting in abortion. Bitches with premature luteal failure in the SubQ group still had serum deslorelin concentrations >100 pg/ml 20 days after implant insertion, suggesting a possible association between prolonged deslorelin release and luteal failure.

Atrial fibrillation detected by continuous electrocardiographic monitoring using implantable loop recorder to prevent stroke in individuals at risk (the LOOP study): Rationale and design of a large randomized controlled trial.

PubMed

Diederichsen, Søren Zöga; Haugan, Ketil Jørgen; Køber, Lars; Højberg, Søren; Brandes, Axel; Kronborg, Christian; Graff, Claus; Holst, Anders Gaarsdal; Nielsen, Jonas Bille; Krieger, Derk; Svendsen, Jesper Hastrup

2017-05-01

Atrial fibrillation (AF) increases the rate of stroke 5-fold, and AF-related strokes have a poorer prognosis compared with non-AF-related strokes. Atrial fibrillation and stroke constitute an intensifying challenge, and health care organizations are calling for awareness on the topic. Previous studies have demonstrated that AF is often asymptomatic and consequently undiagnosed. The implantable loop recorder (ILR) allows for continuous, long-term electrocardiographic monitoring with daily transmission of arrhythmia information, potentially leading to improvement in AF detection and stroke prevention. The LOOP study is an investigator-initiated, randomized controlled trial with 6,000 participants randomized 3:1 to a control group or to receive an ILR with continuous electrocardiographic monitoring. Participants are identified from Danish registries and are eligible for inclusion if 70years or older and previously diagnosed as having at least one of the following conditions: hypertension, diabetes mellitus, heart failure, or previous stroke. Exclusion criteria include history of AF and current oral anticoagulation treatment. When an AF episode lasting ≥6minutes is detected, oral anticoagulation will be initiated according to guidelines. Expected follow-up is 4years. The primary end point is time to stroke or systemic embolism, whereas secondary end points include time to AF diagnosis and death. The LOOP study will evaluate health benefits and cost-effectiveness of ILR as a screening tool for AF to prevent stroke in patients at risk. Secondary objectives include identification of risk factors for the development of AF and characterization of arrhythmias in the population. The trial holds the potential to influence the future of stroke prevention. Copyright © 2017 Elsevier Inc. All rights reserved.

Superiority of automatic remote monitoring compared with in-person evaluation for scheduled ICD follow-up in the TRUST trial - testing execution of the recommendations

PubMed Central

Varma, Niraj; Michalski, Justin; Stambler, Bruce; Pavri, Behzad B.

2014-01-01

Aims To test recommended implantable cardioverter defibrillator (ICD) follow-up methods by ‘in-person evaluations’ (IPE) vs. ‘remote Home Monitoring’ (HM). Methods and results ICD patients were randomized 2:1 to automatic HM or to Conventional monitoring, with follow-up checks scheduled at 3, 6, 9, 12, and 15 months post-implant. Conventional patients were evaluated with IPE only. Home Monitoring patients were assessed remotely only for 1 year between 3 and 15 month evaluations. Adherence to follow-up was measured. HM and Conventional patients were similar (age 63 years, 72% male, left ventricular ejection fraction 29%, primary prevention 73%, DDD 57%). Conventional management suffered greater patient attrition during the trial (20.1 vs. 14.2% in HM, P = 0.007). Three month follow-up occurred in 84% in both groups. There was 100% adherence (5 of 5 checks) in 47.3% Conventional vs. 59.7% HM (P < 0.001). Between 3 and 15 months, HM exhibited superior (2.2×) adherence to scheduled follow-up [incidence of failed follow up was 146 of 2421 (6.0%) in HM vs. 145 of 1098 (13.2%) in Conventional, P < 0.001] and punctuality. In HM (daily transmission success rate median 91%), transmission loss caused only 22 of 2275 (0.97%) failed HM evaluations between 3 and 15 months; others resulted from clinic oversight. Overall IPE failure rate in Conventional [193 of 1841 (10.5%) exceeded that in HM [97 of 1484 (6.5%), P < 0.001] by 62%, i.e. HM patients remained more loyal to IPE when this was mandated. Conclusion Automatic remote monitoring better preserves patient retention and adherence to scheduled follow-up compared with IPE. Clinical trial registration NCT00336284. PMID:24595864

Short-term Effects of High-Dose Caffeine on Cardiac Arrhythmias in Patients With Heart Failure: A Randomized Clinical Trial.

PubMed

Zuchinali, Priccila; Souza, Gabriela C; Pimentel, Maurício; Chemello, Diego; Zimerman, André; Giaretta, Vanessa; Salamoni, Joyce; Fracasso, Bianca; Zimerman, Leandro I; Rohde, Luis E

2016-12-01

The presumed proarrhythmic action of caffeine is controversial. Few studies have assessed the effect of high doses of caffeine in patients with heart failure due to left ventricular systolic dysfunction at high risk for ventricular arrhythmias. To compare the effect of high-dose caffeine or placebo on the frequency of supraventricular and ventricular arrhythmias, both at rest and during a symptom-limited exercise test. Double-blinded randomized clinical trial with a crossover design conducted at the heart failure and cardiac transplant clinic of a tertiary-care university hospital. The trial included patients with chronic heart failure with moderate-to-severe systolic dysfunction (left ventricular ejection fraction <45%) and New York Heart Association functional class I to III between March 5, 2013, and October 2, 2015. Caffeine (100 mg) or lactose capsules, in addition to 5 doses of 100 mL decaffeinated coffee at 1-hour intervals, for a total of 500 mg of caffeine or placebo during a 5-hour protocol. After a 1-week washout period, the protocol was repeated. Number and percentage of ventricular and supraventricular premature beats assessed by continuous electrocardiographic monitoring. We enrolled 51 patients (37 [74%] male; mean [SD] age, 60.6 [10.9] years) with predominantly moderate-to-severe left ventricular systolic dysfunction (mean [SD] left ventricular ejection fraction, 29% [7%]); 31 [61%] had an implantable cardioverter-defibrillator device. No significant differences between the caffeine and placebo groups were observed in the number of ventricular (185 vs 239 beats, respectively; P = .47) and supraventricular premature beats (6 vs 6 beats, respectively; P = .44), as well as in couplets, bigeminal cycles, or nonsustained tachycardia during continuous electrocardiographic monitoring. Exercise test-derived variables, such as ventricular and supraventricular premature beats, duration of exercise, estimated peak oxygen consumption, and heart rate, were not influenced by caffeine ingestion. We observed no increases in ventricular premature beats (91 vs 223 vs 207 beats, respectively) in patients with higher levels of plasma caffeine concentration compared with lower plasma levels (P = .91) or with the placebo group (P = .74). Acute ingestion of high doses of caffeine did not induce arrhythmias in patients with systolic heart failure and at high risk for ventricular arrhythmias. clinicaltrials.gov Identifier: NCT02045992.

The Ahmed versus Baerveldt study: three-year treatment outcomes.

PubMed

Christakis, Panos G; Tsai, James C; Kalenak, Jeffrey W; Zurakowski, David; Cantor, Louis B; Kammer, Jeffrey A; Ahmed, Iqbal I K

2013-11-01

To compare 2 commonly used aqueous drainage devices for the treatment of refractory glaucoma. International, multicenter, randomized trial. Patients aged 18 years or older with uncontrolled or high-risk glaucoma refractory to maximum medical therapy, many of whom had failed trabeculoplasty and trabeculectomy. Eligible patients were randomized to an Ahmed-FP7 valve implant (New World Medical, Inc., Rancho Cucamonga, CA) or a Baerveldt-350 implant (Abbott Medical Optics, Inc., Santa Ana, CA) using a standardized surgical technique. The primary outcome was failure, defined as intraocular pressure (IOP) outside of the target range (5-18 mmHg, with ≥20% reduction from baseline) for 2 consecutive visits after 3 months, vision-threatening complications, de novo glaucoma procedures, or loss of light perception. Secondary outcome measures include IOP, medication use, visual acuity, complications, and interventions. A total of 238 patients were enrolled and randomized; 124 received the Ahmed implant and 114 received the Baerveldt implant. Baseline characteristics were similar in both groups. Half the study group had secondary glaucoma, and 37% had previously failed trabeculectomy. The mean preoperative IOP was 31.4±10.8 mmHg on 3.1±1.0 glaucoma medications. Median baseline Snellen visual acuity was 20/100. At 3 years, the cumulative probability of failure was 51% in the Ahmed group and 34% in the Baerveldt group (P = 0.03). Mean IOP was 15.7±4.8 mmHg in the Ahmed group (49% reduction) and 14.4±5.1 mmHg in the Baerveldt group (55% reduction; P = 0.09). Mean number of glaucoma medications was 1.8±1.4 in the Ahmed group (42% reduction) and 1.1±1.3 in the Baerveldt group (65% reduction; P = 0.002). There was a moderate but similar decrease in visual acuity in both groups (P< 0.001). The 2 groups had similar complication rates (52% Ahmed, 62% Baerveldt; P = 0.12); however, the Baerveldt group had a higher rate of hypotony-related vision-threatening complications (0% Ahmed, 6% Baerveldt; P = 0.005). More interventions were required in the Baerveldt group, although the difference did not reach statistical significance (38% Ahmed, 50% Baerveldt; P = 0.07). Most complications were transient, and most interventions were slit-lamp procedures. Both devices were effective in reducing IOP and glaucoma medications. The Baerveldt group had a lower failure rate and required fewer medications than the Ahmed group after 3 years, but it experienced more hypotony-related vision-threatening complications. Copyright © 2013 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Biventricular support with the Jarvik 2000 axial flow pump: a feasibility study.

PubMed

Radovancevic, Branislav; Gregoric, Igor D; Tamez, Daniel; Vrtovec, Bojan; Tuzun, Egemen; Chee, Hyun Keun; Moore, Sheila; Jarvik, Robert K; Frazier, O H

2003-01-01

Patients with congestive heart failure who are supported with a left ventricular assist device (LVAD) may experience right ventricular dysfunction or failure that requires support with a right ventricular assist device (RVAD). To determine the feasibility of using a clinically available axial flow ventricular assist device as an RVAD, we implanted Jarvik 2000 pumps in the left ventricle and right atrium of two Corriente crossbred calves (approximately 100 kg each) by way of a left thoracotomy and then analyzed the hemodynamic effects in the mechanically fibrillated heart at various LVAD and RVAD speeds. Right atrial implantation of the device required no modification of either the device or the surgical technique used for left ventricular implantation. Satisfactory biventricular support was achieved during fibrillation as evidenced by an increase in mean aortic pressure from 34 mm Hg with the pumps off to 78 mm Hg with the pumps generating a flow rate of 4.8 L/min. These results indicate that the Jarvik 2000 pump, which can provide chronic circulatory support and can be powered by external batteries, is a feasible option for right ventricular support after LVAD implantation and is capable of completely supporting the circulation in patients with global heart failure.

SEM and fractography analysis of screw thread loosening in dental implants.

PubMed

Scarano, A; Quaranta, M; Traini, T; Piattelli, M; Piattelli, A

2007-01-01

Biological and technical failures of implants have already been reported. Mechanical factors are certainly of importance in implant failures, even if their exact nature has not yet been established. The abutment screw fracture or loosening represents a rare, but quite unpleasant failure. The aim of the present research is an analysis and structural examination of screw thread or abutment loosening compared with screw threads or abutment without loosening. The loosening of screw threads was compared to screw thread without loosening of three different implant systems; Branemark (Nobel Biocare, Gothenburg, Sweden), T.B.R. implant systems (Benax, Ancona, Italy) and Restore (Lifecore Biomedical, Chaska, Minnesota, USA). In this study broken screws were excluded. A total of 16 screw thread loosenings were observed (Group I) (4 Branemark, 4 T.B.R and 5 Restore), 10 screw threads without loosening were removed (Group II), and 6 screw threads as received by the manufacturer (unused) (Group III) were used as control (2 Branemark, 2 T.B.R and 2 Restore). The loosened abutment screws were retrieved and analyzed under SEM. Many alterations and deformations were present in concavities and convexities of screw threads in group I. No macroscopic alterations or deformations were observed in groups II and III. A statistical difference of the presence of microcracks were observed between screw threads with an abutment loosening and screw threads without an abutment loosening.

Early failure mechanisms of constrained tripolar acetabular sockets used in revision total hip arthroplasty.

PubMed

Cooke, Christopher C; Hozack, William; Lavernia, Carlos; Sharkey, Peter; Shastri, Shani; Rothman, Richard H

2003-10-01

Fifty-eight patients received an Osteonics constrained acetabular implant for recurrent instability (46), girdlestone reimplant (8), correction of leg lengthening (3), and periprosthetic fracture (1). The constrained liner was inserted into a cementless shell (49), cemented into a pre-existing cementless shell (6), cemented into a cage (2), and cemented directly into the acetabular bone (1). Eight patients (13.8%) required reoperation for failure of the constrained implant. Type I failure (bone-prosthesis interface) occurred in 3 cases. Two cementless shells became loose, and in 1 patient, the constrained liner was cemented into an acetabular cage, which then failed by pivoting laterally about the superior fixation screws. Type II failure (liner locking mechanism) occurred in 2 cases. Type III failure (femoral head locking mechanism) occurred in 3 patients. Seven of the 8 failures occurred in patients with recurrent instability. Constrained liners are an effective method for treatment during revision total hip arthroplasty but should be used in select cases only.

Recent refinements to cranial implants for rhesus macaques (Macaca mulatta)

PubMed Central

Johnston, Jessica M.; Cohen, Yale E.; Shirley, Harry; Tsunada, Joji; Bennur, Sharath; Christison-Lagay, Kate; Veeder, Christin L.

2017-01-01

The advent of cranial implants revolutionized primate neurophysiological research because they allow researchers to stably record neural activity from monkeys during active behavior. Cranial implants have improved over the years since their introduction, but chronic implants still increase the risk for medical complications including bacterial contamination and resultant infection, chronic inflammation, bone and tissue loss and complications related to the use of dental acrylic. These complications can lead to implant failure and early termination of study protocols. In an effort to reduce complications, we describe several refinements that have helped us improve cranial implants and the wellbeing of implanted primates. PMID:27096188

The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) Randomized Controlled Trial: Phase 1 Results on Dynamics of Early Intervention With Remote Monitoring

PubMed Central

Da Costa, Antoine; Ricci, Renato Pietro; Quesada, Aurelio; Favale, Stefano; Iacopino, Saverio; Romeo, Francesco; Risi, Arnaldo; Mangoni di S Stefano, Lorenza; Navarro, Xavier; Biffi, Mauro; Santini, Massimo; Burri, Haran

2013-01-01

Background Remote monitoring (RM) in patients with advanced heart failure and cardiac resynchronization therapy defibrillators (CRT-D) may reduce delays in clinical decisions by transmitting automatic alerts. However, this strategy has never been tested specifically in this patient population, with alerts for lung fluid overload, and in a European setting. Objective The main objective of Phase 1 (presented here) is to evaluate if RM strategy is able to reduce time from device-detected events to clinical decisions. Methods In this multicenter randomized controlled trial, patients with moderate to severe heart failure implanted with CRT-D devices were randomized to a Remote group (with remote follow-up and wireless automatic alerts) or to a Control group (with standard follow-up without alerts). The primary endpoint of Phase 1 was the delay between an alert event and clinical decisions related to the event in the first 154 enrolled patients followed for 1 year. Results The median delay from device-detected events to clinical decisions was considerably shorter in the Remote group compared to the Control group: 2 (25th-75th percentile, 1-4) days vs 29 (25th-75th percentile, 3-51) days respectively, P=.004. In-hospital visits were reduced in the Remote group (2.0 visits/patient/year vs 3.2 visits/patient/year in the Control group, 37.5% relative reduction, P<.001). Automatic alerts were successfully transmitted in 93% of events occurring outside the hospital in the Remote group. The annual rate of all-cause hospitalizations per patient did not differ between the two groups (P=.65). Conclusions RM in CRT-D patients with advanced heart failure allows physicians to promptly react to clinically relevant automatic alerts and significantly reduces the burden of in-hospital visits. Trial Registration Clinicaltrials.gov NCT00885677; http://clinicaltrials.gov/show/NCT00885677 (Archived by WebCite at http://www.webcitation.org/6IkcCJ7NF). PMID:23965236

Total Artificial Heart Implantation after Excision of Right Ventricular Angiosarcoma.

PubMed

Bruckner, Brian A; Abu Saleh, Walid K; Al Jabbari, Odeaa; Copeland, Jack G; Estep, Jerry D; Loebe, Matthias; Reardon, Michael J

2016-06-01

Primary cardiac sarcomas, although rare, are aggressive and lethal, requiring thorough surgical resection and adjuvant chemotherapy for the best possible outcome. We report the case of a 32-year-old woman who underwent total artificial heart implantation for right-sided heart failure caused by right ventricular angiosarcoma. For the first several weeks in intensive care, the patient recovered uneventfully. However, a postoperative liver biopsy indicated hepatocellular injury consistent with preoperative chemotherapy. She developed continuing liver failure, from which she died despite good cardiac function.

Myocardial recovery during mechanical circulatory support: long-term outcome and elective ventricular assist device implantation to promote recovery as a treatment goal.

PubMed

Dandel, Michael; Hetzer, Roland

2015-01-01

Even after incomplete myocardial recovery during mechanical circulatory support, long-term survival rates after ventricular assist device (VAD) explantation can be better than those expected after heart transplantation even for patients with chronic non-ischemic cardiomyopathy as the underlying cause for VAD implantation. The elective therapeutic use of ventricular assist devices for heart failure reversal in its early stage is a future goal. It may be possible to achieve it by developing tools to predict heart failure reversibility even before ventricular assist device implantation and increasing the number of weaning candidates by improvement of adjunctive therapies to optimize unloading-promoted recovery.  Special attention is focused on the long-term stability of cardiac remission after VAD removal, the clinical relevance unloading-promoted myocardial recovery and on the current knowledge about a potential prediction of myocardial recovery during long-term VAD support already before VAD implantation.

New Ti-Alloys and Surface Modifications to Improve the Mechanical Properties and the Biological Response to Orthopedic and Dental Implants: A Review

PubMed Central

Kirmanidou, Yvoni; Sidira, Margarita; Drosou, Maria-Eleni; Bennani, Vincent; Bakopoulou, Athina; Tsouknidas, Alexander; Michailidis, Nikolaos; Michalakis, Konstantinos

2016-01-01

Titanium implants are widely used in the orthopedic and dentistry fields for many decades, for joint arthroplasties, spinal and maxillofacial reconstructions, and dental prostheses. However, despite the quite satisfactory survival rates failures still exist. New Ti-alloys and surface treatments have been developed, in an attempt to overcome those failures. This review provides information about new Ti-alloys that provide better mechanical properties to the implants, such as superelasticity, mechanical strength, and corrosion resistance. Furthermore, in vitro and in vivo studies, which investigate the biocompatibility and cytotoxicity of these new biomaterials, are introduced. In addition, data regarding the bioactivity of new surface treatments and surface topographies on Ti-implants is provided. The aim of this paper is to discuss the current trends, advantages, and disadvantages of new titanium-based biomaterials, fabricated to enhance the quality of life of many patients around the world. PMID:26885506

Angulated Dental Implants in Posterior Maxilla FEA and Experimental Verification

PubMed Central

Hamed, Hamed A.; Marzook, Hamdy A.; Ghoneem, Nahed E.; El–Anwar, Mohamed I.

2018-01-01

AIM: This study aimed to evaluate the effect of different implant angulations in posterior maxilla on stress distribution by finite element analysis and verify its results experimentally. METHODS: Two simplified models were prepared for an implant placed vertically and tilted 25° piercing the maxillary sinus. Geometric models’ components were prepared by Autodesk Inventor then assembled in ANSYS for finite element analysis. The results of finite element analysis were verified against experimental trials results which were statistically analysed using student t-test (level of significance p < 0.05). RESULTS: Implant - abutment complex absorbed the load energy in case of vertical implant better than the case of angulated one. That was reflected on cortical bone stress, while both cases showed stress levels within the physiological limits. Comparing results between FEA and experiment trials showed full agreement. CONCLUSION: It was found that the tilted implant by 25° can be utilised in the posterior region maxilla for replacing maxillary first molar avoiding sinus penetration. The implant-bone interface and peri-implant bones received the highest Von Mises stress. Implant - bone interface with angulated implant received about 66% more stresses than the straight one. PMID:29531612

Increased crown-to-implant ratio may not be a risk factor for dental implant failure under appropriate plaque control.

PubMed

Okada, Shinsuke; Koretake, Katsunori; Miyamoto, Yasunari; Oue, Hiroshi; Akagawa, Yasumasa

2013-01-01

The aim of this study was to evaluate whether increased crown-to-implant (C/I) ratio influences implant stability or not under proper healthy control of peri-implant mucosa. The hypothesis of this study is that implant stability can be maintained despite High C/I, under appropriate plaque control. Five male Beagle-Labrador hybrid dogs (2 years old) were used. Their bilateral mandibular premolar extraction was performed. After allowing 12 weeks for bone healing, 3 types of vertical marginal bone loss were simultaneously prepared randomly. Then, 30 titanium implants were placed in the edentulous areas and defined as High C/I, Mid C/I and Low C/I groups. This time point was designated as the baseline (0 Week). Twelve weeks after implant placement, metal superstructures were cemented to the implants and an occlusal plate was set at the opposite side. At the same time, Calcein green was injected for remodeling evaluation. Implants were loaded by feeding the dogs a hard pellet diet. Tooth brushing was performed 5 days per week during the study to maintain healthy peri-implant mucosa. Twenty-four weeks following implant placement, the interface structure was evaluated clinically, radiologically, and histologically. Implant stability quotient (ISQ) increased with time in all 3 groups, without any significant correlation with the C/I value (p >0.05). Moreover, mean marginal bone loss adjacent around implants in all 3 groups ranged between 0.11 and 0.19 mm, with no significant difference (p >0.05). Many fluorescence-labeled bones are shown in the High C/I group. It is considered that high remodeling activity prevent marginal bone loss in the High C/I group and this may provide favorable implant stability under proper plaque control. These findings suggest that increased C/I may not be a risk factor for implant failure if the peri-implant mucosa is kept healthy, as was the case in this animal model.

Long-Term Outcomes of Stenting the Proximal Left Anterior Descending Artery in the PROTECT Trial.

PubMed

Roguin, Ariel; Camenzind, Edoardo; Kerner, Arthur; Beyar, Rafael; Boersma, Eric; Mauri, Laura; Steg, Ph Gabriel; Wijns, William

2017-03-27

This study sought to compare the outcomes of patients undergoing drug-eluting stent implantation according to lesion location within or outside the proximal left anterior descending (LAD) artery. Proximal LAD artery involvement is considered uniquely in revascularization guidelines. The impact of LAD lesion location on long-term outcomes after revascularization is poorly understood in context of current percutaneous coronary intervention and medical therapy. Among 8,709 patients enrolled in PROTECT (Patient Related Outcomes with Endeavor Versus Cypher Stenting Trial), a multicenter percutaneous coronary intervention trial, we compared the outcomes of 2,534 patients (29.1%) (3,871 lesions [31.5%]) with stents implanted in the proximal LAD to 6,172 patients (70.9%) (8,419 lesions [68.5%]) with stents implanted outside the proximal LAD. At the 4-year follow-up, death rates were the same (5.8% vs. 5.8%; p > 0.999), but more myocardial infarctions occurred in the proximal LAD group (6.2% vs. 4.9%; p = 0.015). The rate of clinically driven target vessel failure (TVF) (14.8% vs. 13.5%; p = 0.109), major adverse cardiac event(s) (MACE) (15.0% vs. 13.7%; hazard ratio: 1.1; 95% confidence interval: 0.97 to 1.31; p = 0.139), and stent thrombosis (2.1% vs. 2.0%; p = 0.800) were similar. Drug-eluting stent type had no interaction with MACE or TVF. In multivariate analysis, the proximal LAD was a predictor of myocardial infarction (p = 0.038) but not of TVF (p = 0.149) or MACE (p = 0.069). In this study of contemporary percutaneous coronary intervention, proximal LAD location was associated with higher rates of myocardial infarction during the long-term follow-up, but there were no differences in stent thrombosis, death, TVF, or overall MACE. This finding may suggest that, in the drug-eluting stent era, proximal LAD no longer confers a different prognosis than other lesion sites. (Randomized Study Comparing Endeavor With Cypher Stents [PROTECT]; NCT00476957). Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Evaluation of efficacy of a new hybrid fusion device: a randomized, two-centre controlled trial.

PubMed

Siewe, Jan; Bredow, Jan; Oppermann, Johannes; Koy, Timmo; Delank, Stefan; Knoell, Peter; Eysel, Peer; Sobottke, Rolf; Zarghooni, Kourosh; Röllinghoff, Marc

2014-09-05

The 360° fusion of lumbar segments is a common and well-researched therapy to treat various diseases of the spine. But it changes the biomechanics of the spine and may cause adjacent segment disease (ASD). Among the many techniques developed to avoid this complication, one appears promising. It combines a rigid fusion with a flexible pedicle screw system (hybrid instrumentation, "topping off"). However, its clinical significance is still uncertain due to the lack of conclusive data. The study is a randomized, therapy-controlled, two-centre trial conducted in a clinical setting at two university hospitals. If they meet the criteria, outpatients presenting with degenerative disc disease, facet joint arthrosis or spondylolisthesis will be included in the study and randomized into two groups: a control group undergoing conventional fusion surgery (PLIF - posterior lumbar intervertebral fusion), and an intervention group undergoing fusion surgery using a new flexible pedicle screw system (PLIF + "topping off"), which was brought on the market in 2013. Follow-up examination will take place immediately after surgery, after 6 weeks and after 6, 12, 24 and 36 months. An ongoing assessment will be performed every year.Outcome measurements will include quality of life and pain assessments using validated questionnaires (ODI - Ostwestry Disability Index, SF-36™ - Short Form Health Survey 36, COMI - Core Outcome Measure Index). In addition, clinical and radiologic ASD, sagittal balance parameters and duration of work disability will be assessed. Inpatient and 6-month mortality, surgery-related data (e.g., intraoperative complications, blood loss, length of incision, surgical duration), postoperative complications (e.g. implant failure), adverse events, and serious adverse events will be monitored and documented throughout the study. New hybrid "topping off" systems might improve the outcome of lumbar spine fusion. But to date, there is a serious lack of and a great need of convincing data on safety or efficacy, including benefits and harms to the patients, of these systems. Health care providers are particularly interested in such data as these implants are much more expensive than conventional implants. In such a case, randomized clinical trials are the best way to evaluate benefits and risks. NCT01852526.

Smoking increases salivary arginase activity in patients with dental implants.

PubMed

Queiroz, D A; Cortelli, J R; Holzhausen, M; Rodrigues, E; Aquino, D R; Saad, W A

2009-09-01

It is believed that an increased arginase activity may lead to less nitric oxide production, which consequently increases the susceptibility to bacterial infection. Considering the hypothesis that smoking may alter the arginase activity and that smoking is considered a risk factor to dental implant survival, the present study aimed at evaluating the effect of smoking on the salivary arginase activity of patients with dental implants. Salivary samples of 41 subjects were collected: ten non-smoking and with no dental implants (group A), ten non-smoking subjects with dental implants (group B), ten smoking subjects with implants (group C), and 11 smoking subjects with no dental implants (group D). The levels of salivary arginase activity were determined by the measurement of L-ornithine and expressed as mIU/mg of protein. A significant increase in the salivary arginase activity was verified in groups C (64.26 +/- 16.95) and D (49.55 +/- 10.01) compared to groups A (10.04 +/- 1.95, p = 0.00001 and p = 0.0110, groups C and D, respectively) and B (11.77 +/- 1.45, p = 0.00001 and p = 0.0147, groups C and D, respectively). No significant difference was found between groups C and D (p = 0.32). Within the limits of the present study, it can be concluded that salivary arginase activity is increased in smoking subjects with dental implants in contrast to non-smoking subjects with dental implants, therefore suggesting a possible mechanism by which cigarette smoking may lead to implant failure. The analysis of salivary arginase activity may represent an important tool to prevent implant failure in the near future.

Impact of implant size on cement filling in hip resurfacing arthroplasty.

PubMed

de Haan, Roel; Buls, Nico; Scheerlinck, Thierry

2014-01-01

Larger proportions of cement within femoral resurfacing implants might result in thermal bone necrosis. We postulate that smaller components are filled with proportionally more cement, causing an elevated failure rate. A total of 19 femoral heads were fitted with polymeric replicas of ReCap (Biomet) resurfacing components fixed with low-viscosity cement. Two specimens were used for each even size between 40 and 56 mm and one for size 58 mm. All specimens were imaged with computed tomography, and the cement thickness and bone density were analyzed. The average cement mantle thickness was 2.63 mm and was not correlated with the implant size. However, specimen with low bone density had thicker cement mantles regardless of size. The average filling index was 36.65% and was correlated to both implant size and bone density. Smaller implants and specimens with lower bone density contained proportionally more cement than larger implants. According to a linear regression model, bone density but not implant size influenced cement thickness. However, both implant size and bone density had a significant impact on the filling index. Large proportions of cement within the resurfacing head have the potential to generate thermal bone necrosis and implant failure. When considering hip resurfacing in patients with a small femoral head and/or osteoporotic bone, extra care should be taken to avoid thermal bone necrosis, and alternative cementing techniques or even cementless implants should be considered. This study should help delimiting the indications for hip resurfacing and to choose an optimal cementing technique taking implant size into account.

Inductionless or limited shock testing is possible in most patients with implantable cardioverter- defibrillators/cardiac resynchronization therapy defibrillators: results of the multicenter ASSURE Study (Arrhythmia Single Shock Defibrillation Threshold Testing Versus Upper Limit of Vulnerability: Risk Reduction Evaluation With Implantable Cardioverter-Defibrillator Implantations).

PubMed

Day, John D; Doshi, Rahul N; Belott, Peter; Birgersdotter-Green, Ulrika; Behboodikhah, Mahnaz; Ott, Peter; Glatter, Kathryn A; Tobias, Serge; Frumin, Howard; Lee, Byron K; Merillat, John; Wiener, Isaac; Wang, Samuel; Grogin, Harlan; Chun, Sung; Patrawalla, Rob; Crandall, Brian; Osborn, Jeffrey S; Weiss, J Peter; Lappe, Donald L; Neuman, Stacey

2007-05-08

Implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators have relied on multiple ventricular fibrillation (VF) induction/defibrillation tests at implantation to ensure that the device can reliably sense, detect, and convert VF. The ASSURE Study (Arrhythmia Single Shock Defibrillation Threshold Testing Versus Upper Limit of Vulnerability: Risk Reduction Evaluation With Implantable Cardioverter-Defibrillator Implantations) is the first large, multicenter, prospective trial comparing vulnerability safety margin testing versus defibrillation safety margin testing with a single VF induction/defibrillation. A total of 426 patients receiving an implantable cardioverter-defibrillator or cardiac resynchronization therapy defibrillator underwent vulnerability safety margin or defibrillation safety margin screening at 14 J in a randomized order. After this, patients underwent confirmatory testing, which required 2 VF conversions without failure at < or = 21 J. Patients who passed their first 14-J and confirmatory tests, irrespective of the results of their second 14-J test, had their devices programmed to a 21-J shock for ventricular tachycardia (VT) or VF > or = 200 bpm and were followed up for 1 year. Of 420 patients who underwent 14-J vulnerability safety margin screening, 322 (76.7%) passed. Of these, 317 (98.4%) also passed 21-J confirmatory tests. Of 416 patients who underwent 14-J defibrillation safety margin screening, 343 (82.5%) passed, and 338 (98.5%) also passed 21-J confirmatory tests. Most clinical VT/VF episodes (32 of 37, or 86%) were terminated by the first shock, with no difference in first shock success. In all observed cases in which the first shock was unsuccessful, subsequent shocks terminated VT/VF without complication. Although spontaneous episodes of fast VT/VF were limited, there was no difference in the odds of first shock efficacy between groups. Screening with vulnerability safety margin or defibrillation safety margin may allow for inductionless or limited shock testing in most patients.

Accuracy of Seattle Heart Failure Model and HeartMate II Risk Score in Non-Inotrope-Dependent Advanced Heart Failure Patients: Insights From the ROADMAP Study (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients).

PubMed

Lanfear, David E; Levy, Wayne C; Stehlik, Josef; Estep, Jerry D; Rogers, Joseph G; Shah, Keyur B; Boyle, Andrew J; Chuang, Joyce; Farrar, David J; Starling, Randall C

2017-05-01

Timing of left ventricular assist device (LVAD) implantation in advanced heart failure patients not on inotropes is unclear. Relevant prediction models exist (SHFM [Seattle Heart Failure Model] and HMRS [HeartMate II Risk Score]), but use in this group is not established. ROADMAP (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients) is a prospective, multicenter, nonrandomized study of 200 advanced heart failure patients not on inotropes who met indications for LVAD implantation, comparing the effectiveness of HeartMate II support versus optimal medical management. We compared SHFM-predicted versus observed survival (overall survival and LVAD-free survival) in the optimal medical management arm (n=103) and HMRS-predicted versus observed survival in all LVAD patients (n=111) using Cox modeling, receiver-operator characteristic (ROC) curves, and calibration plots. In the optimal medical management cohort, the SHFM was a significant predictor of survival (hazard ratio=2.98; P <0.001; ROC area under the curve=0.71; P <0.001) but not LVAD-free survival (hazard ratio=1.41; P =0.097; ROC area under the curve=0.56; P =0.314). SHFM showed adequate calibration for survival but overestimated LVAD-free survival. In the LVAD cohort, the HMRS had marginal discrimination at 3 (Cox P =0.23; ROC area under the curve=0.71; P =0.026) and 12 months (Cox P =0.036; ROC area under the curve=0.62; P =0.122), but calibration was poor, underestimating survival across time and risk subgroups. In non-inotrope-dependent advanced heart failure patients receiving optimal medical management, the SHFM was predictive of overall survival but underestimated the risk of clinical worsening and LVAD implantation. Among LVAD patients, the HMRS had marginal discrimination and underestimated survival post-LVAD implantation. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01452802. © 2017 American Heart Association, Inc.

Trabeculectomy With Mitomycin C or Ahmed Valve Implantation in Eyes With Uveitic Glaucoma.

PubMed

Bettis, Daniel I; Morshedi, Richard G; Chaya, Craig; Goldsmith, Jason; Crandall, Alan; Zabriskie, Norm

2015-01-01

To report and compare the results of trabeculectomy with mitomycin C (MMC) and Ahmed valve implantation in the management of uveitic glaucoma. The records of 41 eyes of 29 patients who underwent trabeculectomy with MMC or Ahmed valve implantation for uveitic glaucoma were retrospectively reviewed. Seventeen eyes underwent trabeculectomy with MMC, and 24 eyes underwent Ahmed valve implantation. Outcomes included postoperative intraocular pressure (IOP), percent reduction from preoperative IOP, postoperative number of medications, time to failure, and complications. Mean follow-up was 21.2 months in the trabeculectomy group and 23.8 months in the valve group (P=0.06). Mean IOP was reduced from 29.2 to 18.4 mm Hg in the trabeculectomy group (31.3%), compared with a reduction from 33.4 to 15.5 mm Hg in the Ahmed valve group (42.7%, P=0.53). Postoperatively, 1.76 medications were used in the trabeculectomy group, compared with 1.83 medications in the Ahmed valve group (P=0.89). Cumulative success at 1 year was 66.7% in the trabeculectomy group, compared with 100% in the Ahmed valve group (P=0.02). Mean time to failure was 8.36 months with trabeculectomy, and 21.8 months with Ahmed valve (P=0.02). Complications in both groups were typically rare and self-limited, with recurrent inflammation being most common. Although both trabeculectomy with MMC and Ahmed valve implantation are reasonable surgical options in the management of uncontrolled uveitic glaucoma, Ahmed valve implantation was associated with higher cumulative success rate at 1 year and a longer mean time to failure.

Auditory Midbrain Implant: Research and Development Towards a Second Clinical Trial

PubMed Central

Lim, Hubert H.; Lenarz, Thomas

2015-01-01

The cochlear implant is considered one of the most successful neural prostheses to date, which was made possible by visionaries who continued to develop the cochlear implant through multiple technological and clinical challenges. However, patients without a functional auditory nerve or implantable cochlea cannot benefit from a cochlear implant. The focus of the paper is to review the development and translation of a new type of central auditory prosthesis for this group of patients, which is known as the auditory midbrain implant (AMI) and is designed for electrical stimulation within the inferior colliculus. The rationale and results for the first AMI clinical study using a multi-site single-shank array will be presented initially. Although the AMI has achieved encouraging results in terms of safety and improvements in lip-reading capabilities and environmental awareness, it has not yet provided sufficient speech perception. Animal and human data will then be presented to show that a two-shank AMI array can potentially improve hearing performance by targeting specific neurons of the inferior colliculus. Modifications to the AMI array design, stimulation strategy, and surgical approach have been made that are expected to improve hearing performance in the patients implanted with a two-shank array in an upcoming clinical trial funded by the National Institutes of Health. Positive outcomes from this clinical trial will motivate new efforts and developments toward improving central auditory prostheses for those who cannot sufficiently benefit from cochlear implants. PMID:25613994

Implant decontamination with 2% chlorhexidine during surgical peri-implantitis treatment: a randomized, double-blind, controlled trial.

PubMed

de Waal, Y C M; Raghoebar, G M; Meijer, H J A; Winkel, E G; van Winkelhoff, A J

2015-09-01

The objective of this randomized, double-blind, controlled trial was to evaluate the clinical, radiographic, and microbiological effects of implant surface decontamination with a 2% chlorhexidine (CHX) solution in comparison with a 0.12% chlorhexidine + 0.05% cetylpyridinium chloride (CPC) solution during resective surgical peri-implantitis treatment. Forty-four patients (108 implants) with peri-implantitis were treated with resective surgical treatment consisting of bone re-contouring, surface debridement and chemical decontamination, and apically repositioned flap. Patients were randomly allocated to decontamination with a 2% CHX solution (test group) or 0.12% CHX + 0.05% CPC (control group). Clinical and radiographic parameters were recorded before treatment (baseline), and at 3, 6, and 12 months after treatment. Microbiological parameters were recorded during surgery. Multilevel analysis showed no significant differences in bleeding, suppuration, probing pocket depth, and radiographic bone loss between control and test group over three follow-up measurements (3, 6, and 12 months) from baseline. Both decontamination procedures resulted in significant reductions in anaerobic bacterial counts on the implant surface, but no significant difference was noted between control and test group (mean log 3.37 ± 2.34 vs. 3.65 ± 2.87, P = 0.99). The use of a 2% CHX solution for implant surface decontamination during resective peri-implantitis therapy does not lead to improved clinical, radiographic, or microbiological results compared with a 0.12% CHX + 0.05% CPC solution. Overall, the additional use of CHX reduces anaerobic bacterial load on the implant surface better than mechanical debridement alone, but does not seem to enhance clinical treatment outcomes (ClinicalTrials.gov number NCT01852253). © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Reliability and commercialization of oxidized VCSEL

NASA Astrophysics Data System (ADS)

Li, Alice; Pan, Jin-Shan; Lai, Horng-Ching; Lee, Bor-Lin; Wu, Jack; Lin, Yung-Sen; Huo, Tai-Chan; Wu, Calvin; Huang, Kai-Feng

2003-06-01

The reliability of oxidized VCSEL has similar result to implanted VCSEL. This paper presents our work on reliability data of oxidized VCSEL device and also the comparison with implanted VCSEL. The MTTF of oxidized VCSEL is 2.73 x 106 hrs at 55°C, 6 mA and failure rate ~ 1 FITs for the first 2 years operation. The reliability data of oxidized VCSEL includes activation energy, MTTF (mean-time-to failure), failure rate prediction, and 85°C / 85% humidity test will be presented below. Commercialization of oxidized VCSEL is demonstrated such as VCSEL structure, manufacturing facility, and packaging. A cost effective approach is key to its success in applications such as Datacomm.

78 FR 69645 - Ohio State University, et al.; Notice of Consolidated Decision on Applications for Duty-Free...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-20

... failure of orthopaedic implants, and also the evaluation of new materials and implant surfaces for tissue engineering applications. The cryo-preparation, cryo-transfer and cryo-imaging capabilities will enable...

Uterine DCs are crucial for decidua formation during embryo implantation in mice

PubMed Central

Plaks, Vicki; Birnberg, Tal; Berkutzki, Tamara; Sela, Shay; BenYashar, Adi; Kalchenko, Vyacheslav; Mor, Gil; Keshet, Eli; Dekel, Nava; Neeman, Michal; Jung, Steffen

2008-01-01

Implantation is a key stage during pregnancy, as the fate of the embryo is often decided upon its first contact with the maternal endometrium. Around this time, DCs accumulate in the uterus; however, their role in pregnancy and, more specifically, implantation, remains unknown. We investigated the function of uterine DCs (uDCs) during implantation using a transgenic mouse model that allows conditional ablation of uDCs in a spatially and temporally regulated manner. Depletion of uDCs resulted in a severe impairment of the implantation process, leading to embryo resorption. Depletion of uDCs also caused embryo resorption in syngeneic and T cell–deficient pregnancies, which argues against a failure to establish immunological tolerance during implantation. Moreover, even in the absence of embryos, experimentally induced deciduae failed to adequately form. Implantation failure was associated with impaired decidual proliferation and differentiation. Dynamic contrast-enhanced MRI revealed perturbed angiogenesis characterized by reduced vascular expansion and attenuated maturation. We suggest therefore that uDCs directly fine-tune decidual angiogenesis by providing two critical factors, sFlt1 and TGF-β1, that promote coordinated blood vessel maturation. Collectively, uDCs appear to govern uterine receptivity, independent of their predicted role in immunological tolerance, by regulating tissue remodeling and angiogenesis. Importantly, our results may aid in understanding the limited implantation success of embryos transferred following in vitro fertilization. PMID:19033665

Mechanical assessment of grit blasting surface treatments of dental implants.

PubMed

Shemtov-Yona, K; Rittel, D; Dorogoy, A

2014-11-01

This paper investigates the influence of surface preparation treatments of dental implants on their potential (mechanical) fatigue failure, with emphasis on grit-blasting. The investigation includes limited fatigue testing of implants, showing the relationship between fatigue life and surface damage condition. Those observations are corroborated by a detailed failure analysis of retrieved fracture dental implants. In both cases, the negative effect of embedded alumina particles related to the grit-blasting process is identified. The study also comprises a numerical simulation part of the grit blasting process that reveals, for a given implant material and particle size, the existence of a velocity threshold, below which the rough surface is obtained without damage, and beyond which the creation of significant surface damage will severely reduce the fatigue life, thus increasing fracture probability. The main outcome of this work is that the overall performance of dental implants comprises, in addition to the biological considerations, mechanical reliability aspects. Fatigue fracture is a central issue, and this study shows that uncontrolled surface roughening grit-blasting treatments can induce significant surface damage which accelerate fatigue fracture under certain conditions, even if those treatments are beneficial to the osseointegration process. Copyright © 2014 Elsevier Ltd. All rights reserved.

Allergic reaction to vanadium causes a diffuse eczematous eruption and titanium alloy orthopedic implant failure.

PubMed

Engelhart, Sally; Segal, Robert J

2017-04-01

Allergy as a cause of adverse outcomes in patients with implanted orthopedic hardware is controversial. Allergy to titanium-based implants has not been well researched, as titanium is traditionally thought to be inert. We highlight the case of a patient who developed systemic dermatitis and implant failure after surgical placement of a titanium alloy (Ti6Al4V) plate in the left foot. The hardware was removed and the eruption cleared in the following weeks. The plate and screws were submitted for metal analysis. The elemental composition of both the plate and screws included 3 major elements-titanium, aluminum, and vanadium-as well as trace elements. Metal analysis revealed that the plate and screws had different microstructures, and electrochemical studies demonstrated that galvanic corrosion could have occurred between the plate and screws due to their different microstructures, contributing to the release of vanadium in vivo. The patient was patch tested with several metals including components of the implant and had a positive patch test reaction only to vanadium trichloride. These findings support a diagnosis of vanadium allergy and suggests that clinicians should consider including vanadium when patch testing patients with a suspected allergic reaction to vanadium-containing implants.

Concurrent Left Ventricular Assist Device (LVAD) Implantation and Percutaneous Temporary RVAD Support via CardiacAssist Protek-Duo TandemHeart to Preempt Right Heart Failure.

PubMed

Schmack, Bastian; Weymann, Alexander; Popov, Aron-Frederik; Patil, Nikhil Prakash; Sabashnikov, Anton; Kremer, Jamila; Farag, Mina; Brcic, Andreas; Lichtenstern, Christoph; Karck, Matthias; Ruhparwar, Arjang

2016-05-05

Right ventricular failure (RVF) is an unfortunate complication that continues to limit outcomes following durable left ventricular assist device (LVAD) implantation. Despite several 'RVF risk scores' having been proposed, preoperative prediction of post-LVAD RVF remains a guesstimate at best. Current strategies for institution of temporary RVAD support are invasive, necessitate additional re-thoracotomy, restrict postoperative mobilization, and/or entail prolonged retention of prosthetic material in-situ. The authors propose a novel surgical strategy comprising simultaneous implantation of a permanent LVAD and percutaneous TandemHeart® plus ProtekDuo® to provide temporary RVAD support and preempt RVF in patients with impaired RV function.

Exercise therapy for an older patient with left ventricular assist device.

PubMed

Park, Won Hah; Seo, Yong Gon; Sung, Ji Dong

2014-06-01

A left ventricular assist device (LVAD) is a mechanical circulation support implanted for patients with end-stage heart failure. It may be used either as a bridge to cardiac transplantation or as a destination therapy. The health of a 75-year-old man with a medical history of systolic heart failure worsened. Therefore, he was recommended to have implanted a LVAD (Thoratec Corp.) as a destination therapy. After the surgery, he was enrolled in patient cardiac rehabilitation for the improvement of dyspnea and exercise capacity. In results, there is an improvement on his exercise capacity and quality of life. For the first time in Korea, we reported a benefit of exercise therapy after being implanted with a LVAD.

Efficacy of intrathoracic impedance and remote monitoring in patients with an implantable device after the 2011 great East Japan earthquake.

PubMed

Suzuki, Hitoshi; Yamada, Shinya; Kamiyama, Yoshiyuki; Takeishi, Yasuchika

2014-01-01

Several studies have revealed that stress after catastrophic disasters can trigger cardiovascular events, however, little is known about its association with the occurrence of heart failure in past earthquakes. The objective of the present study was to determine whether the Great East Japan Earthquake on March 11, 2011, increased the incidence of worsening heart failure in chronic heart failure (CHF) patients with implantable devices. Furthermore, we examined whether intrathoracic impedance using remote monitoring was effective for the management of CHF.We enrolled 44 CHF patients (32 males, mean age 63 ± 12 years) with implantable devices that can check intrathoracic impedance using remote monitoring. We defined the worsening heart failure as accumulated impedance under reference impedance exceeding 60 ohms-days (fluid index threshold), and compared the incidence of worsening heart failure and arrhythmic events 30 days before and after March 11.Within the 30 days after March 11, 10 patients exceeded the threshold compared with only 2 patients in the preceding 30 days (P < 0.05). Although 9 patients using remote monitoring among the 10 patients with threshold crossings were not hospitalized, one patient without the system was hospitalized due to acute decompensated heart failure. On the contrary, arrhythmic events did not change between before and after March 11.Our results suggest that earthquake-induced stress causes an increased risk of worsening heart failure without changes in arrhythmia. Furthermore, intrathoracic impedance using remote monitoring may be a useful tool for the management of CHF in catastrophic disasters.

A multicenter randomized clinical trial of one-rod etonogestrel and two-rod levonorgestrel contraceptive implants with nonrandomized copper-IUD controls: methodology and insertion data.

PubMed

Meirik, Olav; Brache, Vivian; Orawan, Kiriwat; Habib, Ndema Abu; Schmidt, Johannes; Ortayli, Nuriye; Culwell, Kelly; Jackson, Emily; Ali, Moazzam

2013-01-01

Comparative data on etonogestrel and two-rod levonorgestrel contraceptive implants are lacking. A multicenter, open, parallel-group trial with random allocation of implants was performed. For every second implant user, an age-matched woman choosing an intrauterine device (IUD) (TCu380A) was admitted. Methods and data on implant/IUD insertion and 6-week follow-up are reported. A total of 2008 women were randomized to an implant, and 974 women were enrolled in the IUD group. Results from 997 etonogestrel implant users, 997 levonorgestrel implant users and 971 IUD users were analyzed. In the etonogestrel and levonorgestrel groups, respectively, mean insertion durations were 51 (SD 50.2) s and 88 (SD 60.8) s; complication rates at insertion were 0.8% and 0.2%; and at follow-up, 27.2% and 26.7% of women, respectively, had signs or symptoms at the insertion site. At follow-up within 6 weeks after insertion, all implants were in situ, while 2.1% of IUDs were expelled. Performance of etonogestrel and levonorgestrel implants at insertion and within the first 6 weeks is similar. Short-term (6 weeks) continuation rates appear higher for implants than TCu380A. Copyright © 2013 Elsevier Inc. All rights reserved.

Effects of implantation method and temperature on mortality and loss of simulated transmitters in hybrid striped bass

USGS Publications Warehouse

Walsh, M.G.; Bjorgo, K.A.; Isely, J.J.

2000-01-01

To determine the effects of surgical implantation method and temperature on mortality and transmitter loss, we compared two antenna placements (trailing antenna versus shielded needle) and two suture materials (absorbable versus nonabsorbable) in hybrid striped bass Morone saxitilis x Morone chrysops (227-410 mm total length) that had been surgically implanted with simulated transmitters and held at high (22-29??C) and low (12-18??C) temperatures for 120 d. Fish were individually examined after 7, 30, 60. 90. and 120 d to evaluate suture and wound condition as well as transmitter loss. Neither suture material nor antenna placement affected transmitter loss, mortality, or growth at either high or low temperatures. Absorbable sutures were lost more quickly than were nonabsorbable sutures, but they persisted beyond incision closure at both high and low temperatures. At high temperatures, 50% suture loss occurred by 30 d for absorbable sutures and by 60 d for nonabsorbable sutures. Mortality occurred only at high temperatures but was delayed and was likely caused by peritoneal infection. Transmitter loss was not significant; it occurred only in the low-temperature trial and was caused by pressure necrosis at the incision rather than by suture failure. Temperature significantly affected all responses examined in this study. Significant irritation, infection, and mortality occurred in all treatment groups at high temperatures.

A 100-Channel Hermetically Sealed Implantable Device for Chronic Wireless Neurosensing Applications

PubMed Central

Yin, Ming; Borton, David A.; Aceros, Juan; Patterson, William R.; Nurmikko, Arto V.

2014-01-01

A 100-channel fully implantable wireless broadband neural recording system was developed. It features 100 parallel broadband (0.1 Hz–7.8 kHz) neural recording channels, a medical grade 200 mAh Li-ion battery recharged inductively at 150 kHz, and data telemetry using 3.2 GHz to 3.8 GHz FSK modulated wireless link for 48 Mbps Manchester encoded data. All active electronics are hermetically sealed in a titanium enclosure with a sapphire window for electromagnetic transparency. A custom, high-density configuration of 100 individual hermetic feedthrough pins enable connection to an intracortical neural recording microelectrode array. A 100 MHz bandwidth custom receiver was built to remotely receive the FSK signal and achieved −77.7 dBm sensitivity with 10−8 BER at 48 Mbps data rate. ESD testing on all the electronic inputs and outputs has proven that the implantable device satisfies the HBM Class-1B ESD Standard. In addition, the evaluation of the worst-case charge density delivered to the tissue from each I/O pin verifies the patient safety of the device in the event of failure. Finally, the functionality and reliability of the complete device has been tested on-bench and further validated chronically in ongoing freely moving swine and monkey animal trials for more than one year to date. PMID:23853294

Upper Cervical Spinal Cord Stimulation as an Alternative Treatment in Trigeminal Neuropathy.

PubMed

Velásquez, Carlos; Tambirajoo, Kantharuby; Franceschini, Paulo; Eldridge, Paul R; Farah, Jibril Osman

2018-06-01

To describe the indications and outcomes of upper cervical cord stimulation in trigeminal neuropathy. A consecutive single-center series of patients was retrospectively reviewed. It included 12 patients with trigeminal neuropathy treated with upper cervical spinal cord stimulation. Clinical features, complications, and outcomes were reviewed. All patients had a successful trial before the definitive implantation of a spinal cord stimulator at the level of the craniocervical junction. The mean follow-up period was 4.4 years (range, 0.3-21.1 years). The average coverage in the pain zone was 72% and the median baseline, trial, and postoperative numeric rating scale (NRS) was 7, 3, and 3, respectively. When compared with the baseline, the mean reduction achieved in the postoperative average numeric rating scale was 4 points, accounting for a 57.1% pain reduction. The long-term failure rate was 25%. Despite there being enough evidence to consider upper cervical spinal cord stimulation as an effective treatment for patients with neuropathic trigeminal pain, a randomized controlled trial is needed to fully assess its indications and outcomes and compare it with other therapeutic approaches. Copyright © 2018 Elsevier Inc. All rights reserved.

Bidirectional Cardio-Respiratory Interactions in Heart Failure.

PubMed

Radovanović, Nikola N; Pavlović, Siniša U; Milašinović, Goran; Kirćanski, Bratislav; Platiša, Mirjana M

2018-01-01

We investigated cardio-respiratory coupling in patients with heart failure by quantification of bidirectional interactions between cardiac (RR intervals) and respiratory signals with complementary measures of time series analysis. Heart failure patients were divided into three groups of twenty, age and gender matched, subjects: with sinus rhythm (HF-Sin), with sinus rhythm and ventricular extrasystoles (HF-VES), and with permanent atrial fibrillation (HF-AF). We included patients with indication for implantation of implantable cardioverter defibrillator or cardiac resynchronization therapy device. ECG and respiratory signals were simultaneously acquired during 20 min in supine position at spontaneous breathing frequency in 20 healthy control subjects and in patients before device implantation. We used coherence, Granger causality and cross-sample entropy analysis as complementary measures of bidirectional interactions between RR intervals and respiratory rhythm. In heart failure patients with arrhythmias (HF-VES and HF-AF) there is no coherence between signals ( p < 0.01), while in HF-Sin it is reduced ( p < 0.05), compared with control subjects. In all heart failure groups causality between signals is diminished, but with significantly stronger causality of RR signal in respiratory signal in HF-VES. Cross-sample entropy analysis revealed the strongest synchrony between respiratory and RR signal in HF-VES group. Beside respiratory sinus arrhythmia there is another type of cardio-respiratory interaction based on the synchrony between cardiac and respiratory rhythm. Both of them are altered in heart failure patients. Respiratory sinus arrhythmia is reduced in HF-Sin patients and vanished in heart failure patients with arrhythmias. Contrary, in HF-Sin and HF-VES groups, synchrony increased, probably as consequence of some dominant neural compensatory mechanisms. The coupling of cardiac and respiratory rhythm in heart failure patients varies depending on the presence of atrial/ventricular arrhythmias and it could be revealed by complementary methods of time series analysis.

Cemented all-polyethylene and metal-backed polyethylene tibial components used for primary total knee arthroplasty: a systematic review of the literature and meta-analysis of randomized controlled trials involving 1798 primary total knee implants.

PubMed

Voigt, Jeffrey; Mosier, Michael

2011-10-05

The cost of the implant as part of a total knee arthroplasty accounts for a substantial portion of the costs for the overall procedure: all-polyethylene tibial components cost considerably less than cemented metal-backed tibial components. We performed a systematic review of the literature to determine whether the clinical results of lower-cost all-polyethylene tibial components were comparable with the results of a more expensive metal-backed tibial component. We searched The Cochrane Library, MEDLINE, EMBASE, EBSCO CINAHL, the bibliographies of identified articles, orthopaedic meeting abstracts, health technology assessment web sites, and important orthopaedic journals. This search was performed for the years 1990 to the present. No language restriction was applied. We restricted our search to Level-I studies involving participants who received either an all-polyethylene or a metal-backed tibial implant. The primary outcome measures were durability, function, and adverse events. Two reviewers independently screened the papers for inclusion, assessed trial quality, and extracted data. Effects estimates were pooled with use of fixed and random-effects models of risk ratios, calculated with 95% confidence intervals. Heterogeneity was assessed with the I2 statistic. Forest plots were also generated. Data on 1798 primary total knee implants from twelve studies were analyzed. In all studies, the median or mean age of the participants was greater than sixty-seven years, with a majority of the patients being female. There was no difference between patients managed with an all-polyethylene tibial component and those managed with a metal-backed tibial component in terms of adverse events. There was no significant difference between the two groups in terms of the durability of the implants at two, ten, and fifteen years postoperatively, regardless of the year or how durability was defined (revision or radiographic failure). Finally, with use of a variety of validated measures, there was no difference between the two groups in terms of functional status at two, eight, and ten years, regardless of the measure used. A less expensive all-polyethylene component as part of a total knee arthroplasty has results equivalent to those obtained with a cemented metal-backed tibial component. Using a total knee implant with a cemented all-polyethylene tibial component could save the healthcare system substantial money while obtaining equivalent results to more expensive cemented designs and materials.

Geographic differences in heart failure trials.

PubMed

Ferreira, João Pedro; Girerd, Nicolas; Rossignol, Patrick; Zannad, Faiez

2015-09-01

Randomized controlled trials (RCTs) are essential to develop advances in heart failure (HF). The need for increasing numbers of patients (without substantial cost increase) and generalization of results led to the disappearance of international boundaries in large RCTs. The significant geographic differences in patients' characteristics, outcomes, and, most importantly, treatment effect observed in HF trials have recently been highlighted. Whether the observed regional discrepancies in HF trials are due to trial-specific issues, patient heterogeneity, structural differences in countries, or a complex interaction between factors are the questions we propose to debate in this review. To do so, we will analyse and review data from HF trials conducted in different world regions, from heart failure with preserved ejection fraction (HF-PEF), heart failure with reduced ejection fraction (HF-REF), and acute heart failure (AHF). Finally, we will suggest objective and actionable measures in order to mitigate regional discrepancies in future trials, particularly in HF-PEF where prognostic modifying treatments are urgently needed and in which trials are more prone to selection bias, due to a larger patient heterogeneity. © 2015 The Authors European Journal of Heart Failure © 2015 European Society of Cardiology.

Bone bonding in bioactive glass ceramics combined with a new synthesized agent TAK-778.

PubMed

Kato, H; Neo, M; Tamura, J; Nakamura, T

2001-11-01

We studied the stimulatory effects of TAK-778, a new synthetic 3-benzothiepin derivative that promotes osteoblast differentiation, in the bonding of bone to bioactive glass ceramic implants in rabbit tibiae. Smooth-surfaced, rectangular plates (15 x 10 x 2 mm) made of apatite-wollastonite-containing glass ceramic were implanted bilaterally into the proximal metaphyses of rabbit tibiae. Sustained-release microcapsules containing TAK-778 were packed into the medullary cavity in one limb and untreated microcapsules were packed into the contralateral limb to serve as a paired control. At 4, 8, and 16 weeks after implantation, bonding at the bone/implant interfaces was evaluated using a detaching test and histological examination of undecalcified specimens. The tensile failure load increased during weeks 4 to 16 in both groups; the tensile failure load in the TAK-778-treated group was significantly greater than that in the control group at each interval after implantation. Histologically, the TAK-778-treated specimens showed greater active new bone formation mainly in the medullary cavity and more extensive bonding between the implant and bone than the untreated specimens. The results of this study suggest that adding the bone formation-promoting TAK-778 to bioactive glass ceramic implants may significantly accelerate bone apposition to the implants and improve the bonding process at the interface. This would help to establish earlier and stronger bonding of orthopedic ceramic implants to the surrounding bone tissue. Copyright 2001 John Wiley & Sons, Inc.

Non-clinical and Pre-clinical Testing to Demonstrate Safety of the Barostim Neo Electrode for Activation of Carotid Baroreceptors in Chronic Human Implants

PubMed Central

Wilks, Seth J.; Hara, Seth A.; Ross, Erika K.; Nicolai, Evan N.; Pignato, Paul A.; Cates, Adam W.; Ludwig, Kip A.

2017-01-01

The Barostim neo™ electrode was developed by CVRx, Inc.to deliver baroreflex activation therapy (BAT)™ to treat hypertension and heart failure. The neo electrode concept was designed to deliver electrical stimulation to the baroreceptors within the carotid sinus bulb, while minimizing invasiveness of the implant procedure. This device is currently CE marked in Europe, and in a Pivotal (akin to Phase III) Trial in the United States. Here we present the in vitro and in vivo safety testing that was completed in order to obtain necessary regulatory approval prior to conducting human studies in Europe, as well as an FDA Investigational Device Exemption (IDE) to conduct a Pivotal Trial in the United States. Stimulated electrodes (10 mA, 500 μs, 100 Hz) were compared to unstimulated electrodes using optical microscopy and several electrochemical techniques over the course of 27 weeks. Electrode dissolution was evaluated by analyzing trace metal content of solutions in which electrodes were stimulated. Lastly, safety testing under Good Laboratory Practice guidelines was conducted in an ovine animal model over a 12 and 24 week time period, with results processed and evaluated by an independent histopathologist. Long-term stimulation testing indicated that the neo electrode with a sputtered iridium oxide coating can be stimulated at maximal levels for the lifetime of the implant without clinically significant dissolution of platinum or iridium, and without increasing the potential at the electrode interface to cause hydrolysis or significant tissue damage. Histological examination of tissue that was adjacent to the neo electrodes indicated no clinically significant signs of increased inflammation and no arterial stenosis as a result of 6 months of continuous stimulation. The work presented here involved rigorous characterization and evaluation testing of the neo electrode, which was used to support its safety for chronic implantation. The testing strategies discussed provide a starting point and proven framework for testing new neuromodulation electrode concepts to support regulatory approval for clinical studies. PMID:28824361

Dissociations of the Fluocinolone Acetonide Implant: The Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study.

PubMed

Holbrook, Janet T; Sugar, Elizabeth A; Burke, Alyce E; Vitale, Albert T; Thorne, Jennifer E; Davis, Janet L; Jabs, Douglas A

2016-04-01

To describe fluocinolone acetonide implant dissociations in the Multicenter Uveitis Steroid Treatment (MUST) Trial. Randomized clinical trial with extended follow-up. Review of data collected on the first implant in the eye(s) of participants. Dissociation was defined as the drug pellet no longer being affixed to the strut and categorized as spontaneous or surgically related. A total of 250 eyes (146 patients) had at least 1 implant placed. Median follow-up time after implant placement was 6 years (range 0.5-9.2 years). Thirty-four dissociations were reported in 30 participants. There were 22 spontaneous events in 22 participants; 6-year cumulative risk of a spontaneous dissociation was 4.8% (95% confidence interval [CI]: 2.4%-9.1%). The earliest event occurred 4.8 years after placement. Nine of 22 eyes with data had a decline in visual acuity ≥5 letters temporally related to the dissociation. Thirty-nine implant removal surgeries were performed, 33 with replacement. Twelve dissociations were noted during implant removal surgeries in 10 participants (26%, 95% CI 15%-48%); 5 of these eyes had a decline in visual acuity ≥5 letters after surgery. The time from implant placement to removal surgery was longer for the surgeries at which dissociated implants were identified than for those without one (5.7 vs 3.7 years, P < .001). Overall, visual acuity declined 15 or more letters from pre-implant values in 22% of affected eyes; declines were frequently associated with complications of uveitis or its treatment. There is an increasing risk of dissociation of Retisert implants during follow-up; the risk is greater with removal/exchange surgeries, but the risk of both spontaneous and surgically related events increases with longevity of the implants. In 22% of affected eyes visual acuity declined by 15 letters. In the context of eyes with moderate to severe uveitis for years, this rate is not unexpected. Copyright © 2016 Elsevier Inc. All rights reserved.

Automatic patient respiration failure detection system with wireless transmission

NASA Technical Reports Server (NTRS)

Dimeff, J.; Pope, J. M.

1968-01-01

Automatic respiration failure detection system detects respiration failure in patients with a surgically implanted tracheostomy tube, and actuates an audible and/or visual alarm. The system incorporates a miniature radio transmitter so that the patient is unencumbered by wires yet can be monitored from a remote location.

Tobramycin exposure from active calcium sulfate bone graft substitute

PubMed Central

2014-01-01

Background Bone graft substitute such as calcium sulfate are frequently used as carrier material for local antimicrobial therapy in orthopedic surgery. This study aimed to assess the systemic absorption and disposition of tobramycin in patients treated with a tobramycin-laden bone graft substitute (Osteoset® T). Methods Nine blood samples were taken from 12 patients over 10 days after Osteoset® T surgical implantation. Tobramycin concentration was measured by fluorescence polarization. Population pharmacokinetic analysis was performed using NONMEM to assess the average value and variability (CV) of pharmacokinetic parameters. Bioavailability (F) was assessed by equating clearance (CL) with creatinine clearance (Cockcroft CLCr). Based on the final model, simulations with various doses and renal function levels were performed. (ClinicalTrials.gov number, NCT01938417). Results The patients were 52 +/− 20 years old, their mean body weight was 73 +/− 17 kg and their mean CLCr was 119 +/− 55 mL/min. Either 10 g or 20 g Osteoset® T with 4% tobramycin sulfate was implanted in various sites. Concentration profiles remained low and consistent with absorption rate-limited first-order release, while showing important variability. With CL equated to CLCr, mean absorption rate constant (ka) was 0.06 h-1, F was 63% or 32% (CV 74%) for 10 and 20 g Osteoset® T respectively, and volume of distribution (V) was 16.6 L (CV 89%). Simulations predicted sustained high, potentially toxic concentrations with 10 g, 30 g and 50 g Osteoset® T for CLCr values below 10, 20 and 30 mL/min, respectively. Conclusions Osteoset® T does not raise toxicity concerns in subjects without significant renal failure. The risk/benefit ratio might turn unfavorable in case of severe renal failure, even after standard dose implantation. PMID:24593819

Unintended Pregnancies Observed With Combined Use of the Levonorgestrel Contraceptive Implant and Efavirenz-based Antiretroviral Therapy: A Three-Arm Pharmacokinetic Evaluation Over 48 Weeks

PubMed Central

Scarsi, Kimberly K.; Darin, Kristin M.; Nakalema, Shadia; Back, David J.; Byakika-Kibwika, Pauline; Else, Laura J.; Dilly Penchala, Sujan; Buzibye, Allan; Cohn, Susan E.; Merry, Concepta; Lamorde, Mohammed

2016-01-01

Background. Levonorgestrel subdermal implants are preferred contraceptives with an expected failure rate of <1% over 5 years. We assessed the effect of efavirenz- or nevirapine-based antiretroviral therapy (ART) coadministration on levonorgestrel pharmacokinetics. Methods. This nonrandomized, parallel group, pharmacokinetic evaluation was conducted in three groups of human immunodeficiency virus–infected Ugandan women: ART-naive (n = 17), efavirenz-based ART (n = 20), and nevirapine-based ART (n = 20). Levonorgestrel implants were inserted at baseline in all women. Blood was collected at 1, 4, 12, 24, 36, and 48 weeks. The primary endpoint was week 24 levonorgestrel concentrations, compared between the ART-naive group and each ART group by geometric mean ratio (GMR) with 90% confidence interval (CI). Secondary endpoints included week 48 levonorgestrel concentrations and unintended pregnancies. Results. Week 24 geometric mean levonorgestrel concentrations were 528, 280, and 710 pg/mL in the ART-naive, efavirenz, and nevirapine groups, respectively (efavirenz: ART-naive GMR, 0.53; 90% CI, .50, .55 and nevirapine: ART-naive GMR, 1.35; 90% CI, 1.29, 1.43). Week 48 levonorgestrel concentrations were 580, 247, and 664 pg/mL in the ART-naive, efavirenz, and nevirapine groups, respectively (efavirenz: ART-naive GMR, 0.43; 90% CI, .42, .44 and nevirapine: ART-naive GMR, 1.14; 90% CI, 1.14, 1.16). Three pregnancies (3/20, 15%) occurred in the efavirenz group between weeks 36 and 48. No pregnancies occurred in the ART-naive or nevirapine groups. Conclusions. Within 1 year of combined use, levonorgestrel exposure was markedly reduced in participants who received efavirenz-based ART, accompanied by contraceptive failures. In contrast, nevirapine-based ART did not adversely affect levonorgestrel exposure or efficacy. Clinical Trials Registration. NCT01789879. PMID:26646680

Economic impact of remote monitoring after implantable defibrillators implantation in heart failure patients: an analysis from the EFFECT study.

PubMed

Capucci, Alessandro; De Simone, Antonio; Luzi, Mario; Calvi, Valeria; Stabile, Giuseppe; D'Onofrio, Antonio; Maffei, Simone; Leoni, Loira; Morani, Giovanni; Sangiuolo, Raffaele; Amellone, Claudia; Checchinato, Catia; Ammendola, Ernesto; Buja, Gianfranco

2017-09-01

Heart failure (HF) patients with implantable cardioverter-defibrillators (ICD) require admissions for disease management and out-patient visits for disease management and assessment of device performance. These admissions place a significant burden on the National Health Service. Remote monitoring (RM) is an effective alternative to frequent hospital visits. The EFFECT study was a multicentre observational investigation aiming to evaluate the clinical effectiveness of RM compared with in-office visits standard management (SM). The present analysis is an economic evaluation of the results of the EFFECT trial. The present analysis considered the direct consumption of healthcare resources over 12-month follow-up. Standard tariffs were applied to hospitalizations, in-office visits and remote device interrogations. Economic comparisons were also carried out by means of propensity score (PS) analysis to take into account the lack of randomization in the study design. The analysis involved 858 patients with ICD or CRT-D. Of these, 401 (47%) were followed up via an SM approach, while 457 (53%) were assigned to RM. The rate of hospitalizations was 0.27/year in the SM group and 0.16/year in the RM group (risk reduction =0.59; P = 0.0004). In the non-adjusted analysis, the annual cost for each patient was €817 in the SM group and €604 in the RM group (P = 0.014). Propensity score analysis, in which 292 RM patients were matched with 292 SM patients, confirmed the results of the non-adjusted analysis (€872 in the SM group vs. €757 in the RM group; P < 0.0001). There is a reduction in direct healthcare costs of RM for HF patients with ICDs, particularly CRT-D, compared with standard monitoring. http://clinicaltrials.gov/Identifier, NCT01723865. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For Permissions, please email: journals.permissions@oup.com.

Laser-Modified Surface Enhances Osseointegration and Biomechanical Anchorage of Commercially Pure Titanium Implants for Bone-Anchored Hearing Systems

PubMed Central

Omar, Omar; Simonsson, Hanna; Palmquist, Anders; Thomsen, Peter

2016-01-01

Osseointegrated implants inserted in the temporal bone are a vital component of bone-anchored hearing systems (BAHS). Despite low implant failure levels, early loading protocols and simplified procedures necessitate the application of implants which promote bone formation, bone bonding and biomechanical stability. Here, screw-shaped, commercially pure titanium implants were selectively laser ablated within the thread valley using an Nd:YAG laser to produce a microtopography with a superimposed nanotexture and a thickened surface oxide layer. State-of-the-art machined implants served as controls. After eight weeks’ implantation in rabbit tibiae, resonance frequency analysis (RFA) values increased from insertion to retrieval for both implant types, while removal torque (RTQ) measurements showed 153% higher biomechanical anchorage of the laser-modified implants. Comparably high bone area (BA) and bone-implant contact (BIC) were recorded for both implant types but with distinctly different failure patterns following biomechanical testing. Fracture lines appeared within the bone ~30–50 μm from the laser-modified surface, while separation occurred at the bone-implant interface for the machined surface. Strong correlations were found between RTQ and BIC and between RFA at retrieval and BA. In the endosteal threads, where all the bone had formed de novo, the extracellular matrix composition, the mineralised bone area and osteocyte densities were comparable for the two types of implant. Using resin cast etching, osteocyte canaliculi were observed directly approaching the laser-modified implant surface. Transmission electron microscopy showed canaliculi in close proximity to the laser-modified surface, in addition to a highly ordered arrangement of collagen fibrils aligned parallel to the implant surface contour. It is concluded that the physico-chemical surface properties of laser-modified surfaces (thicker oxide, micro- and nanoscale texture) promote bone bonding which may be of benefit in situations where large demands are imposed on biomechanically stable interfaces, such as in early loading and in compromised conditions. PMID:27299883

Lithium chloride enhances bone regeneration and implant osseointegration in osteoporotic conditions.

PubMed

Jin, Yifan; Xu, Lihua; Hu, Xiaohui; Liao, Shixian; Pathak, Janak L; Liu, Jinsong

2016-10-06

Osteoporotic patients have a high risk of dental and orthopedic implant failure. Lithium chloride (LiCl) has been reported to enhance bone formation. However, the role of LiCl in the success rate of dental and orthopedic implants in osteoporotic conditions is still unknown. We investigated whether LiCl enhances implant osseointegration, implant fixation, and bone formation in osteoporotic conditions. Sprague-Dawley female rats (n = 18) were ovariectomized (OVX) to induce osteoporosis, and another nine rats underwent sham surgery. Three months after surgery, titanium implants were implanted in the tibia of the OVX and sham group rats. After implantation, the OVX rats were gavaged with 150 mg/kg/2 days of LiCl (OVX + LiCl group) or saline (OVX group), and sham group rats were gavaged with saline for 3 months. Implant osseointegration and bone formation were analyzed using histology, biomechanical testing, and micro computed tomography (micro-CT). More bone loss was observed in the OVX group compared to the control, and LiCl treatment enhanced bone formation and implant fixation in osteoporotic rats. In the OVX group, bone-implant contact (BIC) was decreased by 81.2 % compared to the sham group. Interestingly, the OVX + LiCl group showed 4.4-fold higher BIC compared to the OVX group. Micro-CT data of tibia from the OVX + LiCl group showed higher bone volume, trabecular thickness, trabecular number, and osseointegration compared to the OVX group. Maximum push-out force and implant-bone interface shear strength were 2.9-fold stronger in the OVX + LiCl group compared to the OVX group. In conclusion, LiCl enhanced implant osseointegration, implant fixation, and bone formation in osteoporotic conditions, suggesting LiCl as a promising therapeutic agent to prevent implant failure and bone loss in osteoporotic conditions.

Simultaneous sinus lift and implant installation: prospective study of consecutive two hundred seventeen sinus lift and four hundred sixty-two implants.

PubMed

Cha, Hyun-Suk; Kim, Andrew; Nowzari, Hessam; Chang, Hoo-Sun; Ahn, Kang-Min

2014-06-01

If less than 4 mm of residual bone is remained in posterior maxilla, two-stage operation is recommended for implant installation. However, if primary stability could be obtained using tapered designed implants, one-stage surgery could be performed with reliable success rate in severely resorbed maxilla. The purpose of this prospective study was to evaluate survival and success rates of the implants simultaneously placed into grafted sinus using rough-surfaced implant. A total of two hundred seventeen consecutive sinus lifting through lateral approach and four hundred sixty-two simultaneous implants were installed from November 2003 for 5.5 years. Xenogenic bone was used solely for bone graft materials. Second surgery was performed around 6 months after operation and porcelain fused metal or gold crown was used for definitive restorations. Cumulative survival and success rates were evaluated according to residual alveolar bone height (RABH), smoking status, and Schneiderian membrane perforation. The mean follow-up was 57.1 ± 15.6 (36-98) months. Of the four hundred sixty-two implants, two hundred sixty-two implants (56.7%: group 1) were installed in posterior maxilla less than 4-mm RABH and two hundred implants (43.3%: group 2) were placed in over 5-mm RABH. The cumulative survival and success rates were 98.91% and 96.54%. There was no statistically significant difference in success rate between group 1 and group 2 (p = .3135). Perforation of the membrane was not related to success (p = .7162), but smoking status is significantly related with implant failure (p = .0003). Sinus lifting with simultaneous implant placement could be used to treat atrophic maxilla in patients with minimal RABH when initial stability could be obtained by using taper designed implants with surgical techniques. Smoking is a possible factor for implant failure. Membrane perforation did not have an adverse effect on implant success if the membrane was repaired with absorbable membrane and fibrin glue. © 2012 Wiley Periodicals, Inc.

Quantification of cancellous bone-compaction due to DHS Blade insertion and influence upon cut-out resistance.

PubMed

Windolf, Markus; Muths, Raphael; Braunstein, Volker; Gueorguiev, Boyko; Hänni, Markus; Schwieger, Karsten

2009-01-01

Compaction of cancellous bone is believed to prevent cut-out. This in vitro study quantified the compaction in the femoral head due to insertion of a dynamic hip screw-blade with and without predrilling and investigated the resulting implant anchorage under cyclic loading. Eight pairs of human cadaveric femoral heads were instrumented with a dynamic hip screw-blade made of Polyetheretherketon. Pairwise instrumentation was performed either with or without predrilling the specimens. CT scanning was performed before and after implantation, to measure bone-compaction. Subsequently the implant was removed and a third scan was performed to analyze the relaxation of the bone structure. Commercial implants were reinserted and the specimens were cyclically loaded until onset of cut-out occurred. The bone-implant interface was monitored by means of fluoroscopic imaging throughout the experiment. Paired t-tests were performed to identify differences regarding compaction, relaxation and cycles to failure. Bone density in the surrounding of the implant increased about 30% for the non-predrilled and 20% for the predrilled group when inserting the implant. After implant removal the predrilled specimens fully relaxed; the non-predrilled group showed about 10% plastic deformation. No differences were found regarding cycles to failure (P=0.32). Significant bone-compaction due to blade insertion was verified. Even though compaction was lower when predrilling the specimens, mainly elastic deformation was present, which is believed to primarily enhance the implant anchorage. Cyclic loading tests confirmed this thesis. The importance of the implantation technique with regard to predrilling is therefore decreased.

Surface modification of implants in long bone.

PubMed

Förster, Yvonne; Rentsch, Claudia; Schneiders, Wolfgang; Bernhardt, Ricardo; Simon, Jan C; Worch, Hartmut; Rammelt, Stefan

2012-01-01

Coatings of orthopedic implants are investigated to improve the osteoinductive and osteoconductive properties of the implant surfaces and thus to enhance periimplant bone formation. By applying coatings that mimic the extracellular matrix a favorable environment for osteoblasts, osteoclasts and their progenitor cells is provided to promote early and strong fixation of implants. It is known that the early bone ongrowth increases primary implant fixation and reduces the risk of implant failure. This review presents an overview of coating titanium and hydroxyapatite implants with components of the extracellular matrix like collagen type I, chondroitin sulfate and RGD peptide in different small and large animal models. The influence of these components on cells, the inflammation process, new bone formation and bone/implant contact is summarized.

Surface modification of implants in long bone

PubMed Central

Förster, Yvonne; Rentsch, Claudia; Schneiders, Wolfgang; Bernhardt, Ricardo; Simon, Jan C.; Worch, Hartmut; Rammelt, Stefan

2012-01-01

Coatings of orthopedic implants are investigated to improve the osteoinductive and osteoconductive properties of the implant surfaces and thus to enhance periimplant bone formation. By applying coatings that mimic the extracellular matrix a favorable environment for osteoblasts, osteoclasts and their progenitor cells is provided to promote early and strong fixation of implants. It is known that the early bone ongrowth increases primary implant fixation and reduces the risk of implant failure. This review presents an overview of coating titanium and hydroxyapatite implants with components of the extracellular matrix like collagen type I, chondroitin sulfate and RGD peptide in different small and large animal models. The influence of these components on cells, the inflammation process, new bone formation and bone/implant contact is summarized. PMID:23507866

Occlusal considerations in implant therapy: clinical guidelines with biomechanical rationale.

PubMed

Kim, Yongsik; Oh, Tae-Ju; Misch, Carl E; Wang, Hom-Lay

2005-02-01

Due to lack of the periodontal ligament, osseointegrated implants, unlike natural teeth, react biomechanically in a different fashion to occlusal force. It is therefore believed that dental implants may be more prone to occlusal overloading, which is often regarded as one of the potential causes for peri-implant bone loss and failure of the implant/implant prosthesis. Overloading factors that may negatively influence on implant longevity include large cantilevers, parafunctions, improper occlusal designs, and premature contacts. Hence, it is important to control implant occlusion within physiologic limit and thus provide optimal implant load to ensure a long-term implant success. The purposes of this paper are to discuss the importance of implant occlusion for implant longevity and to provide clinical guidelines of optimal implant occlusion and possible solutions managing complications related to implant occlusion. It must be emphasized that currently there is no evidence-based, implant-specific concept of occlusion. Future studies in this area are needed to clarify the relationship between occlusion and implant success.

Enhanced bioactive scaffolds for bone tissue regeneration

NASA Astrophysics Data System (ADS)

Karnik, Sonali

Bone injuries are commonly termed as fractures and they vary in their severity and causes. If the fracture is severe and there is loss of bone, implant surgery is prescribed. The response to the implant depends on the patient's physiology and implant material. Sometimes, the compromised physiology and undesired implant reactions lead to post-surgical complications. [4, 5, 20, 28] Efforts have been directed towards the development of efficient implant materials to tackle the problem of post-surgical implant failure. [ 15, 19, 24, 28, 32]. The field of tissue engineering and regenerative medicine involves the use of cells to form a new tissue on bio-absorbable or inert scaffolds. [2, 32] One of the applications of this field is to regenerate the damaged or lost bone by using stem cells or osteoprogenitor cells on scaffolds that can integrate in the host tissue without causing any harmful side effects. [2, 32] A variety of natural, synthetic materials and their combinations have been used to regenerate the damaged bone tissue. [2, 19, 30, 32, 43]. Growth factors have been supplied to progenitor cells to trigger a sequence of metabolic pathways leading to cellular proliferation, differentiation and to enhance their functionality. [56, 57] The challenge persists to supply these proteins, in the range of nano or even picograms, and in a sustained fashion over a period of time. A delivery system has yet to be developed that would mimic the body's inherent mechanism of delivering the growth factor molecules in the required amount to the target organ or tissue. Titanium is the most preferred metal for orthopedic and orthodontic implants. [28, 46, 48] Even though it has better osteogenic properties as compared to other metals and alloys, it still has drawbacks like poor integration into the surrounding host tissue leading to bone resorption and implant failure. [20, 28, 35] It also faces the problem of postsurgical infections that contributes to the implant failure. [26, 37]. The focus of this dissertation was to design and develop novel implant materials for coating titanium to improve its biological properties. These natural and/or semi-synthetic materials improved cellular adhesion, biological response to the scaffolds and prevented growth of bacteria when they were enhanced with growth factor and anti-infective loaded nanotubes. The implant materials showed promise when tested in vitro for cell proliferation, differentiation and bacterial growth inhibition.

Wound Infections Following Implant removal below the knee: the effect of antibiotic prophylaxis; the WIFI-trial, a multi-centre randomized controlled trial.

PubMed

Backes, Manouk; Dingemans, Siem A; Schep, Niels W L; Bloemers, Frank W; Van Dijkman, Bart; Garssen, Frank P; Haverlag, Robert; Hoogendoorn, Jochem M; Joosse, Pieter; Mirck, Boj; Postma, Victor; Ritchie, Ewan; Roerdink, W Herbert; Sintenie, Jan Bernard; Soesman, Nicolaj M R; Sosef, Nico L; Twigt, Bas A; Van Veen, Ruben N; Van der Veen, Alexander H; Van Velde, Romuald; Vos, Dagmar I; De Vries, Mark R; Winkelhagen, Jasper; Goslings, J Carel; Schepers, Tim

2015-02-06

In the Netherlands about 18,000 procedures with implant removal are performed annually following open or closed reduction and fixation of fractures, of which 30-80% concern the foot, ankle and lower leg region. For clean surgical procedures, the rate of postoperative wound infections (POWI) should be less than ~2%. However, rates of 10-12% following implant removal have been reported, specifically after foot, ankle and lower leg fractures. Currently, surgeons individually decide if antibiotics prophylaxis is given, since no guideline exists. This leads to undesirable practice variation. The aim of the study is to assess the (cost-)effectiveness of a single intravenous gift of Cefazolin prior to implant removal following surgical fixation of foot, ankle and/or lower leg fractures. This is a double-blind randomized controlled trial in patients scheduled for implant removal following a foot, ankle or lower leg fracture. Primary outcome is a POWI within 30 days after implant removal. Secondary outcomes are quality of life, functional outcome and costs at 30 days and 6 months after implant removal. With 2 x 250 patients a decrease in POWI rate from 10% to 3.3% (expected rate in clean-contaminated elective orthopaedic trauma procedures) can be detected (Power = 80%, 2-sided alpha = 5%, including 15% lost to follow up). If administration of prophylactic antibiotics prior to implant removal reduces the infectious complication rate, this will offer a strong argument to adopt this as standard practice of care. This will consequently lead to less physical and social disabilities and health care use. A preliminary, conservative estimation suggests yearly cost savings in the Netherlands of € 3.5 million per year. This study is registered at Clinicaltrials.gov ( NCT02225821 ) and the Netherlands Trial Register ( NTR4393 ) and was granted permission by the Medical Ethical Review Committee of the Academic Medical Centre on October 7 2014.

Photodynamic therapy in peri-implantitis

NASA Astrophysics Data System (ADS)

Leretter, Marius; Cândea, Adrian; Topala, Florin

2014-01-01

Peri-implantitis is like Damocles sword, threatening over our final results as is the most common cause of implant failure. It is, was and will be one of the most challenging tasks for the practitioner to deal with. The rough implant surface offers the ideal conditions for the pathogenic bacteria to stick and multiply. Even more, the growing mature biofilm is harder to eliminate. Mechanical cleaning and rinsing is not capable to destroy it entirely. Most treatment protocols include strong antibiotics, disregarding their side effects and interactions with other medications.

Failure mode and effects analysis drastically reduced potential risks in clinical trial conduct.

PubMed

Lee, Howard; Lee, Heechan; Baik, Jungmi; Kim, Hyunjung; Kim, Rachel

2017-01-01

Failure mode and effects analysis (FMEA) is a risk management tool to proactively identify and assess the causes and effects of potential failures in a system, thereby preventing them from happening. The objective of this study was to evaluate effectiveness of FMEA applied to an academic clinical trial center in a tertiary care setting. A multidisciplinary FMEA focus group at the Seoul National University Hospital Clinical Trials Center selected 6 core clinical trial processes, for which potential failure modes were identified and their risk priority number (RPN) was assessed. Remedial action plans for high-risk failure modes (RPN >160) were devised and a follow-up RPN scoring was conducted a year later. A total of 114 failure modes were identified with an RPN score ranging 3-378, which was mainly driven by the severity score. Fourteen failure modes were of high risk, 11 of which were addressed by remedial actions. Rescoring showed a dramatic improvement attributed to reduction in the occurrence and detection scores by >3 and >2 points, respectively. FMEA is a powerful tool to improve quality in clinical trials. The Seoul National University Hospital Clinical Trials Center is expanding its FMEA capability to other core clinical trial processes.

Retrospective analysis of porcelain failures of metal ceramic crowns and fixed partial dentures supported by 729 implants in 152 patients: patient-specific and implant-specific predictors of ceramic failure.

PubMed

Kinsel, Richard P; Lin, Dongming

2009-06-01

Porcelain fracture associated with an implant-supported, metal ceramic crown or fixed partial denture occurs at a higher rate than in tooth-supported restorations, according to the literature. Implant-specific and patient-specific causes of ceramic failure have not been fully evaluated. The purpose of this retrospective study was to evaluate the potential statistical predictors for porcelain fracture of implant-supported, metal ceramic restorations. Over a 6-month period, a consecutive series of patients having previously received implant-supported, metal ceramic fixed restorations were examined during periodic recall appointments. The number of supporting implants, number of dental units, type of restoration, date of prosthesis insertion, location in the dental arch, opposing dentition, type of occlusion, presence of parafunctional habits, use of an occlusal protective device, presence or absence of ceramic fractures, gender, and age were recorded for each patient. The generalized estimating equation (GEE) approach was used for the intrasubject correlated measurements analysis of categorical outcomes (presence or absence of ceramic fractures) to determine which patient- and implant-specific factors would predict porcelain fracture (alpha=.05). Data were collected from 152 patients representing 998 dental units (390 single crowns and 94 fixed partial dentures) supported by 729 implants. Porcelain fractures of 94 dental units occurred in 35 patients. The fractures were significantly (P<.05) associated with opposing implant-supported metal ceramic restorations, bruxism, and not wearing a protective occlusal device. Metal ceramic prostheses (single crown or fixed partial dentures) had approximately 7 times higher odds of porcelain fracture (odds ratio (OR)=7.06; 95% confidence interval (CI): 2.57 to 19.37) and 13 times greater odds of a fracture requiring either repair or replacement (OR=13.95; 95% CI: 2.25 to 86.41) when in occlusion with another implant-supported restoration, as compared to opposing a natural tooth. In addition, patients exhibiting bruxism or not wearing an occlusal device had approximately 7 times higher odds (OR=7.23; 95% CI: 3.86 to 13.54), and 2 times higher odds (OR=1.92; 95% CI: 1.01 to 3.67) of porcelain fracture when compared to patients without bruxism and patients not wearing an occlusal device. Implant-supported metal ceramic single crowns and fixed partial dentures were found to have a significantly higher risk of porcelain fracture in patients with bruxism habits, when a protective occlusal device was not used, and when the restoration opposed another implant-supported metal ceramic restoration.

The peri-implant esthetics: An unforgettable entity

PubMed Central

Dhir, Sangeeta

2011-01-01

Esthetic demands in today's world of dentistry are scaling new heights, and are driven by the zest to look beautiful. The soft tissue esthetics around implants is the foci of attention, which, if failed to meet, leads to unacceptable esthetic failure. The aim of this article is to give a brief overview of the various vital parameters influencing the esthetics governing the peri-implant area. PMID:21976830

Ambulatory Holter monitoring in asymptomatic patients with DDD pacemakers - do we need ACC/AHA Guidelines revision?

PubMed

Chudzik, Michal; Klimczak, Artur; Wranicz, Jerzy Krzysztof

2013-10-31

We sought to determine the usefulness of ambulatory 24-hour Holter monitoring in detecting asymptomatic pacemaker (PM) malfunction episodes in patients with dual-chamber pacemakers whose pacing and sensing parameters were proper, as seen in routine post-implantation follow-ups. Ambulatory 24-hour Holter recordings (HM) were performed in 100 patients with DDD pacemakers 1 day after the implantation. Only asymptomatic patients with proper pacing and sensing parameters (assessed on PM telemetry on the first day post-implantation) were enrolled in the study. The following parameters were assessed: failure to pace, failure to sense (both oversensing and undersensing episodes) as well as the percentage of all PM disturbances. Despite proper sensing and pacing parameters, HM revealed PM disturbances in 23 patients out of 100 (23%). Atrial undersensing episodes were found in 12 patients (p < 0.005) with totally 963 episodes and failure to capture in 1 patient (1%). T wave oversensing was the most common ventricular channel disorder (1316 episodes in 9 patients, p < 0.0005). Malfunction episodes occurred sporadically, leading to pauses of up to 1.6 s or temporary bradycardia, which were, nevertheless, not accompanied by clinical symptoms. No ventricular pacing disturbances were found. Asymptomatic pacemaker dysfunction may be observed in nearly 25% of patients with proper DDD parameters after implantation. Thus, ambulatory HM during the early post-implantation period may be a useful tool to detect the need to reprogram PM parameters.

Ventricular assist devices in pediatrics

PubMed Central

Fuchs, A; Netz, H

2001-01-01

The implantation of a mechanical circulatory device for end-stage ventricular failure is a possible therapeutic approach in adult and pediatric cardiac surgery and cardiology. The aim of this article is to present mechanical circulatory assist devices used in infants and children with special emphasis on extracorporeal membrane oxygenation, Berlin Heart assist device, centrifugal pump and Medos assist device. The success of long-term support with implantable ventricular assist devices in adults and children has led to their increasing use as a bridge to transplantation in patients with otherwise non-treatable left ventricular failure, by transforming a terminal phase heart condition into a treatable cardiopathy. Such therapy allows rehabilitation of patients before elective cardiac transplantation (by removing contraindications to transplantation mainly represented by organ impairment) or acting as a bridge to recovery of the native left ventricular function (depending on underlying cardiac disease). Treatment may also involve permanent device implantation when cardiac transplantation is contraindicated. Indications for the implantation of assisted circulation include all states of cardiac failure that are reversible within a variable period of time or that require heart transplantation. This article will address the current status of ventricular assist devices by examining historical aspects of its development, current technical issues and clinical features of pediatric ventricular assist devices, including indications and contraindications for support. PMID:22368605

Accelerated life-test methods and results for implantable electronic devices with adhesive encapsulation.

PubMed

Huang, Xuechen; Denprasert, Petcharat May; Zhou, Li; Vest, Adriana Nicholson; Kohan, Sam; Loeb, Gerald E

2017-09-01

We have developed and applied new methods to estimate the functional life of miniature, implantable, wireless electronic devices that rely on non-hermetic, adhesive encapsulants such as epoxy. A comb pattern board with a high density of interdigitated electrodes (IDE) could be used to detect incipient failure from water vapor condensation. Inductive coupling of an RF magnetic field was used to provide DC bias and to detect deterioration of an encapsulated comb pattern. Diodes in the implant converted part of the received energy into DC bias on the comb pattern. The capacitance of the comb pattern forms a resonant circuit with the inductor by which the implant receives power. Any moisture affects both the resonant frequency and the Q-factor of the resonance of the circuitry, which was detected wirelessly by its effects on the coupling between two orthogonal RF coils placed around the device. Various defects were introduced into the comb pattern devices to demonstrate sensitivity to failures and to correlate these signals with visual inspection of failures. Optimized encapsulation procedures were validated in accelerated life tests of both comb patterns and a functional neuromuscular stimulator under development. Strong adhesive bonding between epoxy and electronic circuitry proved to be necessary and sufficient to predict 1 year packaging reliability of 99.97% for the neuromuscular stimulator.

Background and design of the profiling biobehavioral responses to mechanical support in advanced heart failure study.

PubMed

Lee, Christopher S; Mudd, James O; Gelow, Jill M; Nguyen, Thuan; Hiatt, Shirin O; Green, Jennifer K; Denfeld, Quin E; Bidwell, Julie T; Grady, Kathleen L

2014-01-01

Unexplained heterogeneity in response to ventricular assist device (VAD) implantation for the management of advanced heart failure impedes our ability to predict favorable outcomes, provide adequate patient and family education, and personalize monitoring and symptom management strategies. The purpose of this article was to describe the background and the design of a study entitled "Profiling Biobehavioral Responses to Mechanical Support in Advanced Heart Failure" (PREMISE). PREMISE is a prospective cohort study designed to (1) identify common and distinct trajectories of change in physical and psychological symptom burden; (2) characterize common trajectories of change in serum biomarkers of myocardial stress, systemic inflammation, and endothelial dysfunction; and (3) quantify associations between symptoms and biomarkers of pathogenesis in adults undergoing VAD implantation. Latent growth mixture modeling, including parallel process and cross-classification modeling, will be used to address the study aims and will entail identifying trajectories, quantifying associations between trajectories and both clinical and quality-of-life outcomes, and identifying predictors of favorable symptom and biomarker responses to VAD implantation. Research findings from the PREMISE study will be used to enhance shared patient and provider decision making and to shape a much-needed new breed of interventions and clinical management strategies that are tailored to differential symptom and pathogenic responses to VAD implantation.

Representative marketing-oriented study on implants in the Austrian population. I. Level of information, sources of information and need for patient information.

PubMed

Tepper, Gabor; Haas, Robert; Mailath, Georg; Teller, Christoph; Zechner, Werner; Watzak, Georg; Watzek, Georg

2003-10-01

The number of dental implants inserted annually worldwide has been estimated to come close to a million. But the level of information available to patients about realistic, evidence-based treatment options by implants is often enough more than fragmentary, and what is disseminated by the media and the industry does not always reflect evidence-based empirical data. This survey of 1000 adults presented with 18 questions was designed to shed light on several points. These were (1). level of subjective patient information, (2). sources of information and prejudices, (3). future demand for implant treatment and target groups for patient information campaigns, and (4). potential misinformation, information deficits, discrepancies of information and how these come about. Of those questioned, 20% said unprompted that implants were a possibility to replace missing teeth. When prompted, 72% said that they knew about dental implants. Most of those questioned felt poorly informed about the options for replacing missing teeth and many knew less about implants than about other alternatives. The dentist was said to be the desired source of information, but 77% of those questioned reported that their dentists did not practice implant dentistry. More than 79% of those questioned did not know whether their dentist worked with implants. Forty-four percent thought that implants should only be placed by specially trained doctors. Sixty-one percent were of the opinion that dentists who provide implant dentistry were better qualified than their nonimplanting colleagues. Half of those questioned attributed implant failures to allergies and incompatibilities, the other half to poor medical care. Only 29% incriminated poor oral hygiene as a cause of implant failure. Future strategies should be geared to more professional public relations and patient information. Internationally operating qualified implant institutions could contribute much to balance discrepant information.

Confident failures: Lapses of working memory reveal a metacognitive blind spot.

PubMed

Adam, Kirsten C S; Vogel, Edward K

2017-07-01

Working memory performance fluctuates dramatically from trial to trial. On many trials, performance is no better than chance. Here, we assessed participants' awareness of working memory failures. We used a whole-report visual working memory task to quantify both trial-by-trial performance and trial-by-trial subjective ratings of inattention to the task. In Experiment 1 (N = 41), participants were probed for task-unrelated thoughts immediately following 20% of trials. In Experiment 2 (N = 30), participants gave a rating of their attentional state following 25% of trials. Finally, in Experiments 3a (N = 44) and 3b (N = 34), participants reported confidence of every response using a simple mouse-click judgment. Attention-state ratings and off-task thoughts predicted the number of items correctly identified on each trial, replicating previous findings that subjective measures of attention state predict working memory performance. However, participants correctly identified failures on only around 28% of failure trials. Across experiments, participants' metacognitive judgments reliably predicted variation in working memory performance but consistently and severely underestimated the extent of failures. Further, individual differences in metacognitive accuracy correlated with overall working memory performance, suggesting that metacognitive monitoring may be key to working memory success.

The effect of placing a bone replacement graft in the gap at immediately placed implants: a randomized clinical trial.

PubMed

Sanz, Mariano; Lindhe, Jan; Alcaraz, Jaime; Sanz-Sanchez, Ignacio; Cecchinato, Denis

2017-08-01

To assess the added value of using a bone replacement graft in combination with immediate implants in reducing the bone dimensional changes occurring in the residual ridge. Randomized parallel controlled clinical trial to study the efficacy of grafting with demineralized bovine bone mineral with 10% collagen (DBBM-C) in the gap between the implant surface and the inner bone walls when the implants were immediately placed in the anterior maxilla. The changes between implant placement and 16 weeks later in the horizontal and vertical crestal bone changes in relation to the implant were evaluated through direct bone measurements using a periodontal probe. Mean changes were compared between the experimental and control sites using parametric statistics. A total of 86 implant sites in 86 subjects were included in the analysis (43 in the test group and 43 in the control group). The horizontal crest dimension underwent marked changes during healing mainly at the buccal aspect of the alveolar crest where this reduction amounted to 1.1 (29%) in the test group and 1.6 mm (38%) in the control group, being these statistically significant (P = 0.02). This outcome was even more pronounced at sites in the anterior maxilla and with thinner buccal bone plates. In conclusion, the results from this clinical trial demonstrated that placing a DBBM-C bone replacement graft significantly reduced the horizontal bone resorptive changes occurring in the buccal bone after the immediate implantation in fresh extraction sockets. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Research on Blastocyst Implantation Essential Factors (BIEFs).

PubMed

Yoshinaga, Koji

2010-06-01

Blastocyst implantation is a process of interaction between embryo and the uterus. To understand this process, this review tries to summarize what blastocyst implantation essential factors (BIEFs) play what roles, as well as where in the uterus and at what stage of implantation process. Addition of more new data to this kind of compilation of information will help the development of diagnosis and treatment of infertility caused by implantation failure. The major, important cells of the endometrial cells that interact with invading blastocyst (trophoblast) are luminal epithelial cells, stromal cells (decidual cells) and resident immune cells. BIEFs regulate these cells to successfully maintain pregnancy.

Two-year survival of Ahmed valve implantation in the first 2 years of life with and without intraoperative mitomycin-C.

PubMed

Al-Mobarak, Faisal; Khan, Arif O

2009-10-01

To evaluate the effect of intraoperative mitomycin-C (MMC) on polypropylene Ahmed glaucoma valve (AGV) survival 2 years after implantation during the first 2 years of life. Retrospective institutional comparative series (1995-2005). Thirty-one eyes of 27 patients (23 unilateral, 4 bilateral; 16 boys, 11 girls) undergoing AGV implantation at a mean age of 11.1 months (standard deviation [SD], 5.46), all of which had 2 years of regular postoperative follow-up. MMC was applied intraoperatively in those cases in the area of AGV implantation in 16 (52%) and was not applied in 15 (48%). In some eyes, MMC was applied intraoperatively in cases done by the surgeons who routinely used MMC for all AGV implantation in young children. Failure was defined as intraocular pressure (IOP) > 22 mmHg with or without glaucoma medications, the need for an additional procedure for IOP control, or the occurrence of significant complications (e.g., endophthalmitis, retinal detachment, persistent hypotony [IOP < 5 mmHg]). Survival was the absence of failure. Failure or significant complications as defined. Mean survival for the non-MMC eyes (22.15 months; standard error [SE], 1.93) was significantly longer than survival for the MMC eyes (16.25 months; SE, 2.17) by the log-rank test (P = 0.025). The difference in cumulative survival at 2 years was also significantly different by log-rank test (P = 0.001): 80.0% (SE 10.3) and 31.3% (SE 11.6), respectively. Rather than improved survival, intraoperative use of MMC was associated with shorter survival 2 years after AGV implantation during the first 2 years of life. We speculate that MMC-induced tissue death can stimulate a reactive fibrosis around the AGV in very young eyes.

Dual-chamber pacemakers for treating symptomatic bradycardia due to sick sinus syndrome without atrioventricular block: a systematic review and economic evaluation.

PubMed

Edwards, Steven J; Karner, Charlotta; Trevor, Nicola; Wakefield, Victoria; Salih, Fatima

2015-08-01

Bradycardia [resting heart rate below 60 beats per minute (b.p.m.)] can be caused by conditions affecting the natural pacemakers of the heart, such as sick sinus syndrome (SSS) and atrioventricular (AV) blocks. People suffering from bradycardia may present with palpitations, exercise intolerance and fainting. The only effective treatment for patients suffering from symptomatic bradycardia is implantation of a permanent pacemaker. To appraise the clinical effectiveness and cost-effectiveness of dual-chamber pacemakers compared with single-chamber atrial pacemakers for treating symptomatic bradycardia in people with SSS and no evidence of AV block. All databases (MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Health Technology Assessment database, NHS Economic Evaluations Database) were searched from inception to June 2014. A systematic review of the clinical and economic literature was carried out in accordance with the general principles published by the Centre for Reviews and Dissemination. Randomised controlled trials (RCTs) evaluating dual-chamber and single-chamber atrial pacemakers and economic evaluations were included. Pairwise meta-analysis was carried out. A de novo economic model was developed. Of 493 references, six RCTs were included in the review. The results were predominantly influenced by the largest trial DANPACE. Dual-chamber pacing was associated with a statistically significant reduction in reoperation [odds ratio (OR) 0.48, 95% confidence interval (CI) 0.36 to 0.63] compared with single-chamber atrial pacing. The difference is primarily because of the development of AV block requiring upgrade to a dual-chamber device. The risk of paroxysmal atrial fibrillation was also reduced with dual-chamber pacing compared with single-chamber atrial pacing (OR 0.75, 95% CI 0.59 to 0.96). No statistically significant difference was found between the pacing modes for mortality, heart failure, stroke, chronic atrial fibrillation or quality of life. However, the risk of developing heart failure may vary with age and device. The de novo economic model shows that dual-chamber pacemakers are more expensive and more effective than single-chamber atrial devices, resulting in a base-case incremental cost-effectiveness ratio (ICER) of £6506. The ICER remains below £20,000 in probabilistic sensitivity analysis, structural sensitivity analysis and most scenario analyses and one-way sensitivity analyses. The risk of heart failure may have an impact on the decision to use dual-chamber or single-chamber atrial pacemakers. Results from an analysis based on age (> 75 years or ≤ 75 years) and risk of heart failure indicate that dual-chamber pacemakers dominate single-chamber atrial pacemakers (i.e. are less expensive and more effective) in older patients, whereas dual-chamber pacemakers are dominated by (i.e. more expensive and less effective) single-chamber atrial pacemakers in younger patients. However, these results are based on a subgroup analysis and should be treated with caution. In patients with SSS without evidence of impaired AV conduction, dual-chamber pacemakers appear to be cost-effective compared with single-chamber atrial pacemakers. The risk of developing a complete AV block and the lack of tools to identify patients at high risk of developing the condition argue for the implantation of a dual-chamber pacemaker programmed to minimise unnecessary ventricular pacing. However, considerations have to be made around the risk of developing heart failure, which may depend on age and device. This study is registered as PROSPERO CRD42013006708. The National Institute for Health Research Health Technology Assessment programme.

Successful continuous-flow left ventricular assist device implantation with adjuvant tricuspid valve repair for advanced heart failure.

PubMed

Lee, Chih-Hsien; Wei, Jeng

The prevalence of end-stage heart failure (HF) is on the increase, however, the availability of donor hearts remains limited. Left ventricular assist devices (LVADs) are increasingly being used for treating patients with end-stage HF. LVADs are not only used as a bridge to transplantation but also as a destination therapy. HeartMate II, a new-generation, continuous-flow LVAD (cf-LVAD), is currently an established treatment option for patients with HF. Technological progress and increasing implantation of cf-LVADs have significantly improved survival in patients with end-stage HF. Here we report a case of a patient with end-stage HF who was successfully supported using cf-LVAD implantation with adjuvant tricuspid valve repair in a general district hospital.

Outcomes of patients with right ventricular failure on milrinone after left ventricular assist device implantation.

PubMed

Tsiouris, Athanasios; Paone, Gaetano; Brewer, Robert J; Nemeh, Hassan W; Borgi, Jamil; Morgan, Jeffrey A

2015-01-01

Previous studies have grouped together both patients requiring right ventricular assist devices (RVADs) with patients requiring prolonged milrinone therapy after left ventricular assist device (LVAD) implantation. We retrospectively identified 149 patients receiving LVADs and 18 (12.1%) of which developed right ventricular (RV) failure. We then separated these patients into those requiring RVADs versus prolonged milrinone therapy. This included 10 patients who were treated with prolonged milrinone and eight patients who underwent RVAD placement. Overall, the RV failure group had worse survival compared with the non-RV failure cohort (p = 0.038). However, this was only for the subgroup of patients who required RVADs, who had a 1, 6, 12, and 24 month survival of 62.5%, 37.5%, 37.5%, and 37.5%, respectively, versus 96.8%, 92.1%, 86.7%, and 84.4% for patients without RV failure (p < 0.001). Patients treated with prolonged milrinone therapy for RV failure had similar survivals compared with patients without RV failure. In the RV failure group, age, preoperative renal failure, and previous cardiac surgery were predictors of the need for prolonged postoperative milrinone. As LVADs become a more widely used therapy for patients with refractory, end-stage heart failure, it will be important to reduce the incidence of RV failure, as it yields significant morbidity and increases cost.

Analysis and design of ion-implanted bubble memory devices

NASA Astrophysics Data System (ADS)

Wullert, J. R., II; Kryder, M. H.

1987-04-01

4-μm period ion-implanted contiguous disk bubble memory circuits, designed and fabricated at AT&T Bell Laboratories, Murray Hill, NJ, have been investigated. Quasistatic testing has provided information about both the operational bias field ranges and the exact failure modes. A variety of major loop layouts were investigated and two turns found to severely limit bias field margins are discussed. The generation process, using a hairpin nucleator, was tested and several interesting failure modes were uncovered. Propagation on four different minor loop paths was observed and each was found to have characteristic failure modes. The transfer processes, both into and out of the minor loops, were investigated at higher frequencies to avoid local heating due to long transfer pulses at low frequencies. Again specific failure modes were identified. Overall bias margins for the chip were 9% at 50 Oe drive field and were limited by transfer-in.

Emergency contraception. Widely available and effective but disappointing as a public health intervention: a review

PubMed Central

Baird, D.T.; Cameron, S.; Evers, J.L.H.; Gemzell-Danielsson, K.; Glasier, A.; Moreau, C.; Trussell, J.; von Hertzen, H.; Crosignani, P.G.; La Vecchia, C.; Volpe, A.; Glasier, A.; Crosignani, P.G.

2015-01-01

Emergency contraception (EC) prevents pregnancy after unprotected sex or contraceptive failure. Use of EC has increased markedly in countries where a product is available over the counter, yet barriers to availability and use remain. Although effective in clinical trials, it has not yet been possible to show a public health benefit of EC in terms of reduction of unintended pregnancy rates. Selective progesterone receptor modulators developed as emergency contraceptives offer better effectiveness than levonorgestrel, but still EC is less effective than use of ongoing regular contraception. Methods which inhibit ovulation whenever they are taken or which act after ovulation to prevent implantation and strategies to increase the uptake of effective ongoing contraception after EC use would prevent more pregnancies. PMID:25678571

Is Delayed Weightbearing After Matrix-Associated Autologous Chondrocyte Implantation in the Knee Associated With Better Outcomes? A Systematic Review of Randomized Controlled Trials.

PubMed

Kraeutler, Matthew J; Belk, John W; Carver, Trevor J; McCarty, Eric C

2018-05-01

Proper rehabilitation after matrix-associated autologous chondrocyte implantation (MACI) is essential to restore a patient's normal function without overloading the repair site. To evaluate the current literature to assess clinical outcomes of MACI in the knee based on postoperative rehabilitation protocols, namely, the time to return to full weightbearing (WB). Systematic review; Level of evidence, 1. A systematic review was performed to locate studies of level 1 evidence comparing the outcomes of patients who underwent MACI with a 6-week, 8-week, or 10/11-week time period to return to full WB. Patient-reported outcomes assessed included the Knee injury and Osteoarthritis Outcome Score (KOOS), Tegner activity scale, Short Form Health Survey-36 (SF-36), and visual analog scale (VAS) for pain frequency and severity. Seven studies met the inclusion criteria, including a total of 136 patients (138 lesions) who underwent MACI. Treatment failure had occurred in 0.0% of patients in the 6-week group, 7.5% in the 8-week group, and 8.3% in the 10/11-week group at a mean follow-up of 2.5 years ( P = .46). KOOS, SF-36, and VAS scores in each group improved significantly from preoperatively to follow-up ( P < .001). Patients undergoing MACI in the knee can be expected to experience improvement in clinical outcomes with the rehabilitation protocols outlined in this work. No significant differences were seen in failure rates based on the time to return to full WB.

Influence of platform switching on bone-level alterations: a three-year randomized clinical trial.

PubMed

Enkling, N; Jöhren, P; Katsoulis, J; Bayer, S; Jervøe-Storm, P-M; Mericske-Stern, R; Jepsen, S

2013-12-01

The concept of platform switching has been introduced to implant dentistry based on clinical observations of reduced peri-implant crestal bone loss. However, published data are controversial, and most studies are limited to 12 months. The aim of the present randomized clinical trial was to test the hypothesis that platform switching has a positive impact on crestal bone-level changes after 3 years. Two implants with a diameter of 4 mm were inserted crestally in the posterior mandible of 25 patients. The intraindividual allocation of platform switching (3.3-mm platform) and the standard implant (4-mm platform) was randomized. After 3 months of submerged healing, single-tooth crowns were cemented. Patients were followed up at short intervals for monitoring of healing and oral hygiene. Statistical analysis for the influence of time and platform type on bone levels employed the Brunner-Langer model. At 3 years, the mean radiographic peri-implant bone loss was 0.69 ± 0.43 mm (platform switching) and 0.74 ± 0.57 mm (standard platform). The mean intraindividual difference was 0.05 ± 0.58 mm (95% confidence interval: -0.19, 0.29). Crestal bone-level alteration depended on time (p < .001) but not on platform type (p = .363). The present randomized clinical trial could not confirm the hypothesis of a reduced peri-implant crestal bone loss, when implants had been restored according to the concept of platform switching.

Mixing implants of differing metallic composition in the treatment of upper-extremity fractures.

PubMed

Acevedo, Daniel; Loy, Bo Nasmyth; Loy, Bo Nasymuth; Lee, Brian; Omid, Reza; Itamura, John

2013-09-01

Mixing implants with differing metallic compositions has been avoided for fear of galvanic corrosion and subsequent failure of the implants and of bone healing. The purpose of this study was to evaluate upper-extremity fractures treated with open reduction and internal fixation with metallic implants that differed in metallic composition placed on the same bone. The authors studied the effects of using both stainless steel and titanium implants on fracture healing, implant failure, and other complications associated with this method of fixation. Their hypothesis was that combining these metals on the same bone would not cause clinically significant nonunions or undo clinical effects from galvanic corrosion. A retrospective review was performed of 17 patients with upper-extremity fractures fixed with metal implants of differing metallic compositions. The primary endpoint was fracture union. Eight clavicles, 2 proximal humeri, 3 distal humeri, 3 olecranons, and 1 glenoid fracture with an average follow-up 10 months were reviewed. All fractures healed. One patient experienced screw backout, which did not affect healing. This study implies that mixing implants with differing metallic compositions on the same bone for the treatment of fractures does not adversely affect bone healing. No evidence existed of corrosion or an increase in complications with this method of treatment. Contrary to prior belief, small modular hand stainless steel plates can be used to assist in reduction of smaller fracture fragments in combination with anatomic titanium plates to obtain anatomic reduction of the fracture without adversely affecting healing. Copyright 2013, SLACK Incorporated.

Turned versus anodised dental implants: a meta-analysis.

PubMed

Chrcanovic, B R; Albrektsson, T; Wennerberg, A

2016-09-01

The aim of this meta-analysis was to test the null hypothesis of no difference in the implant failure rates, marginal bone loss (MBL)and post-operative infection for patients being rehabilitated by turned versus anodised-surface implants, against the alternative hypothesis of a difference. An electronic search without time or language restrictions was undertaken in November 2015. Eligibility criteria included clinical human studies, either randomised or not. Thirty-eight publications were included. The results suggest a risk ratio of 2·82 (95% CI 1·95-4·06, P < 0·00001) for failure of turned implants, when compared to anodised-surface implants. Sensitivity analyses showed similar results when only the studies inserting implants in maxillae or mandibles were pooled. There were no statistically significant effects of turned implants on the MBL (mean difference-MD 0·02, 95%CI -0·16-0·20; P = 0·82) in comparison to anodised implants. The results of a meta-regression considering the follow-up period as a covariate suggested an increase of the MD with the increase in the follow-up time (MD increase 0·012 mm year(-1) ), however, without a statistical significance (P = 0·813). Due to lack of satisfactory information, meta-analysis for the outcome 'post-operative infection' was not performed. The results have to be interpreted with caution due to the presence of several confounding factors in the included studies. © 2016 John Wiley & Sons Ltd.

MR Imaging of Knee Arthroplasty Implants

PubMed Central

Fritz, Jan; Lurie, Brett

2015-01-01

Primary total knee arthroplasty is a highly effective treatment that relieves pain and improves joint function in a large percentage of patients. Despite an initially satisfactory surgical outcome, pain, dysfunction, and implant failure can occur over time. Identifying the etiology of complications is vital for appropriate management and proper timing of revision. Due to the increasing number of knee arthroplasties performed and decreasing patient age at implantation, there is a demand for accurate diagnosis to determine appropriate treatment of symptomatic joints following knee arthroplasty, and for monitoring of patients at risk. Magnetic resonance (MR) imaging allows for comprehensive imaging evaluation of the tissues surrounding knee arthroplasty implants with metallic components, including the polyethylene components. Optimized conventional and advanced pulse sequences can result in substantial metallic artifact reduction and afford improved visualization of bone, implant-tissue interfaces, and periprosthetic soft tissue for the diagnosis of arthroplasty-related complications. In this review article, we discuss strategies for MR imaging around knee arthroplasty implants and illustrate the imaging appearances of common modes of failure, including aseptic loosening, polyethylene wear–induced synovitis and osteolysis, periprosthetic joint infections, fracture, patellar clunk syndrome, recurrent hemarthrosis, arthrofibrosis, component malalignment, extensor mechanism injury, and instability. A systematic approach is provided for evaluation of MR imaging of knee implants. MR imaging with optimized conventional pulse sequences and advanced metal artifact reduction techniques can contribute important information for diagnosis, prognosis, risk stratification, and surgical planning. ©RSNA, 2015 PMID:26295591

Predicting Failure in Early Acute Prosthetic Joint Infection Treated With Debridement, Antibiotics, and Implant Retention: External Validation of the KLIC Score.

PubMed

Löwik, Claudia A M; Jutte, Paul C; Tornero, Eduard; Ploegmakers, Joris J W; Knobben, Bas A S; de Vries, Astrid J; Zijlstra, Wierd P; Dijkstra, Baukje; Soriano, Alex; Wouthuyzen-Bakker, Marjan

2018-03-27

Debridement, antibiotics, and implant retention (DAIR) is a widely used treatment modality for early acute prosthetic joint infection (PJI). A preoperative risk score was previously designed for predicting DAIR failure, consisting of chronic renal failure (K), liver cirrhosis (L), index surgery (I), cemented prosthesis (C), and C-reactive protein >115 mg/L (KLIC). The aim of this study was to validate the KLIC score in an external cohort. We retrospectively evaluated patients with early acute PJI treated with DAIR between 2006 and 2016 in 3 Dutch hospitals. Early acute PJI was defined as <21 days of symptoms and DAIR performed within 90 days after index surgery. Failure was defined as the need for (1) second DAIR, (2) implant removal, (3) suppressive antimicrobial treatment, or (4) infection-related death within 60 days after debridement. A total of 386 patients were included. Failure occurred in 148 patients (38.3%). Patients with KLIC scores of ≤2, 2.5-3.5, 4-5, 5.5-6.5, and ≥7 had failure rates of 27.9%, 37.1%, 49.3%, 54.5%, and 85.7%, respectively (P < .001). The receiver-operating characteristic curve showed an area under the curve of 0.64 (95% confidence interval 0.59-0.69). A KLIC score higher than 6 points showed a specificity of 97.9%. The KLIC score is a relatively good preoperative risk score for DAIR failure in patients with early acute PJI and appears to be most useful in clinical practice for patients with low or high KLIC scores. Copyright © 2018 Elsevier Inc. All rights reserved.

In vitro characterizations of mesoporous hydroxyapatite as a controlled release delivery device for VEGF in orthopedic applications.

PubMed

Poh, Chye Khoon; Ng, Suxiu; Lim, Tee Yong; Tan, Hark Chuan; Loo, Joachim; Wang, Wilson

2012-11-01

Following bone implant surgery, prolonged ischemic conditions at the implant site often result in postsurgical complications like failure of osseointegration at the bone-implant interface which can lead to implant failure. Thus, restoration of the vascular supply is paramount to the proper development of the bone. High surface area mesostructured materials have been shown to be attractive candidates for bone regeneration to enhance cell adhesion and cell proliferation. This study uses hydroxyapatite, a naturally occurring mineral in the bone, fabricated to a range of suitable pore sizes, infused with vascular endothelial growth factor (VEGF), to be progressively released to stimulate revascularization. In this study, several characterizations including nitrogen adsorption analysis, Fourier-transformed infrared spectroscopy, X-ray diffraction, field emission scanning electron microscope, and transmission electron microscope were used to evaluate the synthesized mesoporous hydroxyapatite (MHA). The results showed that MHA can gradually release VEGF for enhancing revascularization, which is beneficial for orthopedic applications. Copyright © 2012 Wiley Periodicals, Inc.

Comparison of the benefits of cochlear implantation versus contra-lateral routing of signal hearing aids in adult patients with single-sided deafness: study protocol for a prospective within-subject longitudinal trial.

PubMed

Kitterick, Pádraig T; O'Donoghue, Gerard M; Edmondson-Jones, Mark; Marshall, Andrew; Jeffs, Ellen; Craddock, Louise; Riley, Alison; Green, Kevin; O'Driscoll, Martin; Jiang, Dan; Nunn, Terry; Saeed, Shakeel; Aleksy, Wanda; Seeber, Bernhard U

2014-01-01

Individuals with a unilateral severe-to-profound hearing loss, or single-sided deafness, report difficulty with listening in many everyday situations despite having access to well-preserved acoustic hearing in one ear. The standard of care for single-sided deafness available on the UK National Health Service is a contra-lateral routing of signals hearing aid which transfers sounds from the impaired ear to the non-impaired ear. This hearing aid has been found to improve speech understanding in noise when the signal-to-noise ratio is more favourable at the impaired ear than the non-impaired ear. However, the indiscriminate routing of signals to a single ear can have detrimental effects when interfering sounds are located on the side of the impaired ear. Recent published evidence has suggested that cochlear implantation in individuals with a single-sided deafness can restore access to the binaural cues which underpin the ability to localise sounds and segregate speech from other interfering sounds. The current trial was designed to assess the efficacy of cochlear implantation compared to a contra-lateral routing of signals hearing aid in restoring binaural hearing in adults with acquired single-sided deafness. Patients are assessed at baseline and after receiving a contra-lateral routing of signals hearing aid. A cochlear implant is then provided to those patients who do not receive sufficient benefit from the hearing aid. This within-subject longitudinal design reflects the expected care pathway should cochlear implantation be provided for single-sided deafness on the UK National Health Service. The primary endpoints are measures of binaural hearing at baseline, after provision of a contra-lateral routing of signals hearing aid, and after cochlear implantation. Binaural hearing is assessed in terms of the accuracy with which sounds are localised and speech is perceived in background noise. The trial is also designed to measure the impact of the interventions on hearing- and health-related quality of life. This multi-centre trial was designed to provide evidence for the efficacy of cochlear implantation compared to the contra-lateral routing of signals. A purpose-built sound presentation system and established measurement techniques will provide reliable and precise measures of binaural hearing. Current Controlled Trials http://www.controlled-trials.com/ISRCTN33301739 (05/JUL/2013).

PIP breast implant removal: a study of 828 cases.

PubMed

Oulharj, S; Pauchot, J; Tropet, Y

2014-03-01

In March, 2010, the French Health Products Safety Agency suspended the sale of prefilled silicone breast implants manufactured by Poly Implants Prosthèse Prothese (PIP) because of a high failure rate and the use of an inappropriate silicone gel that did not comply with CE marking. These findings led to an international medical crisis. In France, 30,000 female patients had PIP implants. In our Department, 1150 PIP breast implants had been implanted in 630 patients since 2001. A retrospective study was conducted to define the rupture rate of these implants and the complications that arise. The women included in the study underwent implant removal from May 2010 to September 2012 for preventive or curative reasons. Data were collected from medical records that included: results of clinical examination, breast ultrasound before removal, rates of implant rupture, results of biopsy of periprosthetic capsule and pericapsule tissue and postoperative complications. A total of 828 PIP breast implants were removed in 455 patients. The rate of ruptured implants was 7.73% (64/828), corresponding to 11.6% of patients. A periprosthetic effusion was associated with rupture in 44% of cases. Breast ultrasound indicated a rupture for 87 implants; 32% were true positives and 3% were false negatives. Periprosthetic capsule biopsy demonstrated the presence of a foreign body, which seemed to be silicone, in 26% of cases and the presence of inflammation in 13% of cases. No siliconoma-type lesion was identified in the pericapsular tissue at biopsy. A total of 14 implants presented perspiration at removal. A statistically significant difference was found between the rates of rupture for texturised implants as compared to the smooth-surfaced implants. There were eight post-revisional-surgery complications (1%) and three cases of breast adenocarcinoma. The preventive explantation of PIP breast implants is justified given the high failure rate (7.73%) and given patients' exposure to silicone gel that did not comply with CE standards in the absence of rupture, through the early perspiration of implants. Copyright © 2013 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

Load-bearing capacity of screw-retained CAD/CAM-produced titanium implant frameworks (I-Bridge®2) before and after cyclic mechanical loading.

PubMed

Dittmer, Marc Philipp; Nensa, Moritz; Stiesch, Meike; Kohorst, Philipp

2013-01-01

Implant-supported screw-retained fixed dental prostheses (FDPs) produced by CAD/ CAM have been introduced in recent years for the rehabilitation of partial or total endentulous jaws. However, there is a lack of data about the long-term mechanical characteristics. The aim of this study was to investigate the failure mode and the influence of extended cyclic mechanical loading on the load-bearing capacity of these frameworks. Ten five-unit FDP frameworks simulating a free-end situation in the mandibular jaw were manufactured according to the I-Bridge®2-concept (I-Bridge®2, Biomain AB, Helsingborg, Sweden) and each was screw-retained on three differently angulated Astra Tech implants (30º buccal angulation/0º angulation/30º lingual angulation). One half of the specimens was tested for static load-bearing capacity without any further treatment (control), whereas the other half underwent five million cycles of mechanical loading with 100 N as the upper load limit (test). All specimens were loaded until failure in a universal testing machine with an occlusal force applied at the pontics. Load-displacement curves were recorded and the failure mode was macro- and microscopically analyzed. The statistical analysis was performed using a t-test (p=0.05). All the specimens survived cyclic mechanical loading and no obvious failure could be observed. Due to the cyclic mechanical loading, the load-bearing capacity decreased from 8,496 N±196 N (control) to 7,592 N±901 N (test). The cyclic mechanical loading did not significantly influence the load-bearing capacity (p=0.060). The failure mode was almost identical in all specimens: large deformations of the framework at the implant connection area were obvious. The load-bearing capacity of the I-Bridge®2 frameworks is much higher than the clinically relevant occlusal forces, even with considerably angulated implants. However, the performance under functional loading in vivo depends on additional aspects. Further studies are needed to address these aspects.

Load-bearing capacity of screw-retained CAD/CAM-produced titanium implant frameworks (I-Bridge®2) before and after cyclic mechanical loading

PubMed Central

DITTMER, Marc Philipp; NENSA, Moritz; STIESCH, Meike; KOHORST, Philipp

2013-01-01

Implant-supported screw-retained fixed dental prostheses (FDPs) produced by CAD/ CAM have been introduced in recent years for the rehabilitation of partial or total endentulous jaws. However, there is a lack of data about the long-term mechanical characteristics. Objective The aim of this study was to investigate the failure mode and the influence of extended cyclic mechanical loading on the load-bearing capacity of these frameworks. Material and Methods Ten five-unit FDP frameworks simulating a free-end situation in the mandibular jaw were manufactured according to the I-Bridge®2-concept (I-Bridge®2, Biomain AB, Helsingborg, Sweden) and each was screw-retained on three differently angulated Astra Tech implants (30º buccal angulation/0º angulation/30º lingual angulation). One half of the specimens was tested for static load-bearing capacity without any further treatment (control), whereas the other half underwent five million cycles of mechanical loading with 100 N as the upper load limit (test). All specimens were loaded until failure in a universal testing machine with an occlusal force applied at the pontics. Load-displacement curves were recorded and the failure mode was macro- and microscopically analyzed. The statistical analysis was performed using a t-test (p=0.05). Results All the specimens survived cyclic mechanical loading and no obvious failure could be observed. Due to the cyclic mechanical loading, the load-bearing capacity decreased from 8,496 N±196 N (control) to 7,592 N±901 N (test). The cyclic mechanical loading did not significantly influence the load-bearing capacity (p=0.060). The failure mode was almost identical in all specimens: large deformations of the framework at the implant connection area were obvious. Conclusion The load-bearing capacity of the I-Bridge®2 frameworks is much higher than the clinically relevant occlusal forces, even with considerably angulated implants. However, the performance under functional loading in vivo depends on additional aspects. Further studies are needed to address these aspects. PMID:24037068

Comparison of the benefits of cochlear implantation versus contra-lateral routing of signal hearing aids in adult patients with single-sided deafness: study protocol for a prospective within-subject longitudinal trial

PubMed Central

2014-01-01

Background Individuals with a unilateral severe-to-profound hearing loss, or single-sided deafness, report difficulty with listening in many everyday situations despite having access to well-preserved acoustic hearing in one ear. The standard of care for single-sided deafness available on the UK National Health Service is a contra-lateral routing of signals hearing aid which transfers sounds from the impaired ear to the non-impaired ear. This hearing aid has been found to improve speech understanding in noise when the signal-to-noise ratio is more favourable at the impaired ear than the non-impaired ear. However, the indiscriminate routing of signals to a single ear can have detrimental effects when interfering sounds are located on the side of the impaired ear. Recent published evidence has suggested that cochlear implantation in individuals with a single-sided deafness can restore access to the binaural cues which underpin the ability to localise sounds and segregate speech from other interfering sounds. Methods/Design The current trial was designed to assess the efficacy of cochlear implantation compared to a contra-lateral routing of signals hearing aid in restoring binaural hearing in adults with acquired single-sided deafness. Patients are assessed at baseline and after receiving a contra-lateral routing of signals hearing aid. A cochlear implant is then provided to those patients who do not receive sufficient benefit from the hearing aid. This within-subject longitudinal design reflects the expected care pathway should cochlear implantation be provided for single-sided deafness on the UK National Health Service. The primary endpoints are measures of binaural hearing at baseline, after provision of a contra-lateral routing of signals hearing aid, and after cochlear implantation. Binaural hearing is assessed in terms of the accuracy with which sounds are localised and speech is perceived in background noise. The trial is also designed to measure the impact of the interventions on hearing- and health-related quality of life. Discussion This multi-centre trial was designed to provide evidence for the efficacy of cochlear implantation compared to the contra-lateral routing of signals. A purpose-built sound presentation system and established measurement techniques will provide reliable and precise measures of binaural hearing. Trial registration Current Controlled Trials http://www.controlled-trials.com/ISRCTN33301739 (05/JUL/2013) PMID:25152694

Rationale and design of the SERVE-HF study: treatment of sleep-disordered breathing with predominant central sleep apnoea with adaptive servo-ventilation in patients with chronic heart failure.

PubMed

Cowie, Martin R; Woehrle, Holger; Wegscheider, Karl; Angermann, Christiane; d'Ortho, Marie-Pia; Erdmann, Erland; Levy, Patrick; Simonds, Anita; Somers, Virend K; Zannad, Faiez; Teschler, Helmut

2013-08-01

Central sleep apnoea/Cheyne-Stokes respiration (CSA/CSR) is a risk factor for increased mortality and morbidity in heart failure (HF). Adaptive servo-ventilation (ASV) is a non-invasive ventilation modality for the treatment of CSA/CSR in patients with HF. SERVE-HF is a multinational, multicentre, randomized, parallel trial designed to assess the effects of addition of ASV (PaceWave, AutoSet CS; ResMed) to optimal medical management compared with medical management alone (control group) in patients with symptomatic chronic HF, LVEF ≤45%, and predominant CSA. The trial is based on an event-driven group sequential design, and the final analysis will be performed when 651 events have been observed or the study is terminated at one of the two interim analyses. The aim is to randomize ∼1200 patients to be followed for a minimum of 2 years. Patients are to stay in the trial up to study termination. The first patient was randomized in February 2008 and the study is expected to end mid 2015. The primary combined endpoint is the time to first event of all-cause death, unplanned hospitalization (or unplanned prolongation of a planned hospitalization) for worsening (chronic) HF, cardiac transplantation, resuscitation of sudden cardiac arrest, or appropriate life-saving shock for ventricular fibrillation or fast ventricular tachycardia in implantable cardioverter defibrillator patients. The SERVE-HF study is a randomized study that will provide important data on the effect of treatment with ASV on morbidity and mortality, as well as the cost-effectiveness of this therapy, in patients with chronic HF and predominantly CSA/CSR. ISRCTN19572887.

Implants in disabled patients: A review and update

PubMed Central

Romero-Pérez, María J.; Mang-de la Rosa, María R.; López-Jimenez, Julián; Fernández-Feijoo, Javier

2014-01-01

The range of indications for dental implants has broadened enormously owing to their predictability and the improvement of patient satisfaction in terms of stability, comfort, aesthetics and functionality. The aim of this article is to review those indications in patients with mental or physical disabilities as the difficulty to cope with oral hygiene often leads to teeth extraction, adding edentulousness to the impairments already present. Following that goal, available literature in Pubmed database, Scopus, Web of Knowledge and The Cochrane Library database about dental implants placement in these patients has been reviewed, assessing the variables of each study: number of patients, sex, average age, oral hygiene, parafunctional habits, impairment, bone quality, protocol of implant surgery, necessity of deep intravenous sedation or general anesthesia, follow-up period and number of failures. The comparison with studies involving other patient populations without mental or physical impediments did not show statistically significant differences in terms of the failure rate recorded. Although there is not much literature available, the results of this review seem to suggest that osseointegrated oral implants could be a therapeutic option in patients who suffer from any physical or psychological impairment. The success of an oral rehabilitation depends mainly on an adequate selection of the patients. Key words:Implants, disabled, sedation. PMID:24608221

Real-time adjustment of ventricular restraint therapy in heart failure.

PubMed

Ghanta, Ravi K; Lee, Lawrence S; Umakanthan, Ramanan; Laurence, Rita G; Fox, John A; Bolman, Ralph Morton; Cohn, Lawrence H; Chen, Frederick Y

2008-12-01

Current ventricular restraint devices do not allow for either the measurement or adjustment of ventricular restraint level. Periodic adjustment of restraint level post-device implantation may improve therapeutic efficacy. We evaluated the feasibility of an adjustable quantitative ventricular restraint (QVR) technique utilizing a fluid-filled polyurethane epicardial balloon to measure and adjust restraint level post-implantation guided by physiologic parameters. QVR balloons were implanted in nine ovine with post-infarction dilated heart failure. Restraint level was defined by the maximum restraint pressure applied by the balloon to the epicardium at end-diastole. An access line connected the balloon lumen to a subcutaneous portacath to allow percutaneous access. Restraint level was adjusted while left ventricular (LV) end-diastolic volume (EDV) and cardiac output was assessed with simultaneous transthoracic echocardiography. All nine ovine successfully underwent QVR balloon implantation. Post-implantation, restraint level could be measured percutaneously in real-time and dynamically adjusted by instillation and withdrawal of fluid from the balloon lumen. Using simultaneous echocardiography, restraint level could be adjusted based on LV EDV and cardiac output. After QVR therapy for 21 days, LV EDV decreased from 133+/-15 ml to 113+/-17 ml (p<0.05). QVR permits real-time measurement and physiologic adjustment of ventricular restraint therapy after device implantation.

Stereoscopic Analysis of Silicone Breast Implant Shells Damaged by Surgical Instruments.

PubMed

Rapp, Derek A; Neaman, Keith C; Hammond, Dennis C

2015-07-01

Iatrogenic shell injury during the implantation and explantation of silicone gel breast implants may lead to eventual device failure. Identification of the patterns of injury caused by surgical instruments is important when attempting to characterize the cause of shell rupture. Understanding the true causes of device failure may help with its prevention. The purpose of this study was to microscopically characterize patterns of shell injury induced by various surgical instruments. Textured and smooth silicone gel implants were intentionally damaged with a variety of surgical instruments. Various scalpels and surgical scissors ranging in fineness were used to create full-thickness injuries in the implant shell. Optical microscopy and scanning electron microscopy were then used to image the injured area to determine patterns of injury. Full-thickness striations across the thickness of the shell could be seen with damage caused by scissors. The density of these striations correlated directly with the fineness of scissors used. No striations were seen with injuries caused by scalpels. Striations were only observed in injuries caused by scissors and suture needles. Striation density correlated with the coarseness of the cutting edge. No such striations were seen in shells damaged by a scalpel even when the angle of approach was changed. This difference can be of assistance in distinguishing between scissors versus scalpel injury of an implant shell.

Phelligridin D-loaded oral nanotube titanium implant enhances osseointegration and prevents osteolysis in rat mandible.

PubMed

Kim, Ji-Eun; Takanche, Jyoti Shrestha; Kim, Jeong-Seok; Lee, Min-Ho; Jeon, Jae-Gyu; Park, Il-Song; Yi, Ho-Keun

2018-04-12

Poor bone quality and osteolysis are the major causes of implant failure in dentistry. Here, this study tested the effect of phelligridin D-loaded nanotubes titanium (Ti) for bone formation around the dental implants. The purpose of this study was to enhance osseointegration of phelligridin D-loaded implant into the bone for bone formation and prevention of osteolysis. Cell viability, crystal violet staining, Western blot, alizarin red S staining, alkaline phosphatase activity, tartrate-resistant acid phosphatase staining, micro-computed tromography (μ-CT), hematoxylin and eosin (H&E) and immunohistochemical staining were used in vitro and in vivo to test the biocompatibility of phelligridin D. Phelligridin D enhanced osteoblast differentiation and mineralization by increasing bone morphogenic protein-2/7 (BMP-2/7), Osterix, Runx-2, osteoprotegerin (OPG), alkaline phosphatase and inhibited osteoclast differentiation by decreasing receptor activator of nuclear factor kappa-B ligand (RANKL) in MC-3T3 E1 cells. Further, phelligridin D promoted bone regeneration around nanotube Ti implant surface by increasing the levels of BMP-2/7 and OPG in a rat model. Phelligridin D also inhibited osteolysis by suppressing the expression of RANKL. These findings strongly suggest that phelligridin D is a new compound representing a potential therapeutic candidate for implant failure caused by osteolysis and poor bone quality of teeth.

Determining the sample size required to establish whether a medical device is non-inferior to an external benchmark.

PubMed

Sayers, Adrian; Crowther, Michael J; Judge, Andrew; Whitehouse, Michael R; Blom, Ashley W

2017-08-28

The use of benchmarks to assess the performance of implants such as those used in arthroplasty surgery is a widespread practice. It provides surgeons, patients and regulatory authorities with the reassurance that implants used are safe and effective. However, it is not currently clear how or how many implants should be statistically compared with a benchmark to assess whether or not that implant is superior, equivalent, non-inferior or inferior to the performance benchmark of interest.We aim to describe the methods and sample size required to conduct a one-sample non-inferiority study of a medical device for the purposes of benchmarking. Simulation study. Simulation study of a national register of medical devices. We simulated data, with and without a non-informative competing risk, to represent an arthroplasty population and describe three methods of analysis (z-test, 1-Kaplan-Meier and competing risks) commonly used in surgical research. We evaluate the performance of each method using power, bias, root-mean-square error, coverage and CI width. 1-Kaplan-Meier provides an unbiased estimate of implant net failure, which can be used to assess if a surgical device is non-inferior to an external benchmark. Small non-inferiority margins require significantly more individuals to be at risk compared with current benchmarking standards. A non-inferiority testing paradigm provides a useful framework for determining if an implant meets the required performance defined by an external benchmark. Current contemporary benchmarking standards have limited power to detect non-inferiority, and substantially larger samples sizes, in excess of 3200 procedures, are required to achieve a power greater than 60%. It is clear when benchmarking implant performance, net failure estimated using 1-KM is preferential to crude failure estimated by competing risk models. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Comparison of fracture resistance of pressable metal ceramic custom implant abutment with a commercially fabricated CAD/CAM zirconia implant abutment.

PubMed

Protopapadaki, Maria; Monaco, Edward A; Kim, Hyeong-Il; Davis, Elaine L

2013-11-01

The predictable nature of the hot pressing ceramic technique has several applications, but no study was identified that evaluated its application to the fabrication of custom implant abutments. The purpose of this study was to compare the fracture resistance of an experimentally designed pressable metal ceramic custom implant abutment (PR) with that of a duplicate zirconia abutment (ZR). Two groups of narrow platform (NP) (Nobel Replace) implant abutment specimens were fabricated (n=10). The experimental abutment (PR) had a metal substructure cast with ceramic alloy (Lodestar) and veneered with leucite pressable glass ceramic (InLine PoM). Each PR abutment was individually scanned and 10 duplicate CAD/CAM ZR abutments were fabricated for the control group. Ceramic crowns (n=20) with the average dimensions of a human lateral incisor were pressed with lithium disilicate glass ceramic (IPS e.max Press) and bonded on the abutments with a resin luting agent (Multilink Automix). The specimens were subjected to thermocycling, cyclic loading, and finally static loading to failure with a computer-controlled Universal Testing Machine. An independent t test (1 sided) determined whether the mean values of the fracture load differed significantly (α=.05) between the 2 groups. No specimen failed during cyclic loading. Upon static loading, the mean (SD) load to failure was significantly higher for the PR group (525.89 [143.547] N) than for the ZR group (413.70 [35.515] N) for internal connection narrow platform bone-level implants (P=.025). Failure was initiated at the screw and internal connection level for both groups. It is possible to fabricate PR abutments that are stronger than ZR abutments for Nobel Biocare internal connection NP bone-level implants. The screw and the internal connection are the weak links for both groups. Copyright © 2013 Editorial Council for the Journal of Prosthetic Dentistry. Published by Mosby, Inc. All rights reserved.

Comparative Evaluation of Fracture Resistance and Mode of Failure of Zirconia and Titanium Abutments with Different Diameters.

PubMed

Shabanpour, Reza; Mousavi, Niloufar; Ghodsi, Safoura; Alikhasi, Marzieh

2015-08-01

The purpose of the current study was to compare the fracture resistance and mode of failure of zirconia and titanium abutments with different diameters. Fourteen groups of abutments including prefabricated zirconia, copy-milled zirconia and titanium abutments of an implant system (XiVE, Dentsply) were prepared in different diameters. An increasing vertical load was applied to each specimen until failure occurred. Fracture resistance was measured in each group using the universal testing machine. Moreover, the failure modes were studied and categorized as abutment screw fracture, connection area fracture, abutment body fracture, abutment body distortion, screw distortion and connection area distortion. Groups were statistically compared using univariate and post-hoc tests. The level of statistical significance was set at 5%. Fabrication method (p = 0.03) and diameter (p < 0.001) had significant effect on the fracture resistance of abutments. Fracture resistance of abutments with 5.5 mm diameter was higher than other diameters (p < 0.001). The observed modes of failure were dependent on the abutment material as well. All of the prefabricated titanium abutments fractured within the abutment screw. Abutment screw distortion, connection area fracture, and abutment body fracture were the common failure type in other groups. Diameter had a significant effect on fracture resistance of implant abutments, as abutments with greater diameters were more resistant to static loads. Copy-milled abutments showed lower fracture resistance as compared to other experimental groups. Although zirconia abutments have received great popularity among clinicians and even patients selecting them for narrow implants should be with caution.

Failure Modes and Effects Analysis of bilateral same-day cataract surgery

PubMed Central

Shorstein, Neal H.; Lucido, Carol; Carolan, James; Liu, Liyan; Slean, Geraldine; Herrinton, Lisa J.

2017-01-01

PURPOSE To systematically analyze potential process failures related to bilateral same-day cataract surgery toward the goal of improving patient safety. SETTING Twenty-one Kaiser Permanente surgery centers, Northern California, USA. DESIGN Retrospective cohort study. METHODS Quality experts performed a Failure Modes and Effects Analysis (FMEA) that included an evaluation of sterile processing, pharmaceuticals, perioperative clinic and surgical center visits, and biometry. Potential failures in human factors and communication (modes) were identified. Rates of endophthalmitis, toxic anterior segment syndrome (TASS), and unintended intraocular lens (IOL) implantation were assessed in eyes having bilateral same-day surgery from 2010 through 2014. RESULTS The study comprised 4754 eyes. The analysis identified 15 significant potential failure modes. These included lapses in instrument processing and compounding error of intracameral antibiotic that could lead to endophthalmitis or TASS and ambiguous documentation of IOL selection by surgeons, which could lead to unintended IOL implantation. Of the study sample, 1 eye developed endophthalmitis, 1 eye had unintended IOL implantation (rates, 2 per 10 000; 95% confidence intervals [CI] 0.1–12.0 per 10 000), and no eyes developed TASS (upper 95% CI, 8 per 10 000). Recommendations included improving oversight of cleaning and sterilization practices, separating lots of compounded drugs for each eye, and enhancing IOL verification procedures. CONCLUSIONS Potential failure modes and recommended actions in bilateral same-day cataract surgery were determined using a FMEA. These findings might help improve the reliability and safety of bilateral same-day cataract surgery based on current evidence and standards. PMID:28410711

Assessing the Risks Associated with MRI in Patients with a Pacemaker or Defibrillator.

PubMed

Russo, Robert J; Costa, Heather S; Silva, Patricia D; Anderson, Jeffrey L; Arshad, Aysha; Biederman, Robert W W; Boyle, Noel G; Frabizzio, Jennifer V; Birgersdotter-Green, Ulrika; Higgins, Steven L; Lampert, Rachel; Machado, Christian E; Martin, Edward T; Rivard, Andrew L; Rubenstein, Jason C; Schaerf, Raymond H M; Schwartz, Jennifer D; Shah, Dipan J; Tomassoni, Gery F; Tominaga, Gail T; Tonkin, Allison E; Uretsky, Seth; Wolff, Steven D

2017-02-23

The presence of a cardiovascular implantable electronic device has long been a contraindication for the performance of magnetic resonance imaging (MRI). We established a prospective registry to determine the risks associated with MRI at a magnetic field strength of 1.5 tesla for patients who had a pacemaker or implantable cardioverter-defibrillator (ICD) that was "non-MRI-conditional" (i.e., not approved by the Food and Drug Administration for MRI scanning). Patients in the registry were referred for clinically indicated nonthoracic MRI at a field strength of 1.5 tesla. Devices were interrogated before and after MRI with the use of a standardized protocol and were appropriately reprogrammed before the scanning. The primary end points were death, generator or lead failure, induced arrhythmia, loss of capture, or electrical reset during the scanning. The secondary end points were changes in device settings. MRI was performed in 1000 cases in which patients had a pacemaker and in 500 cases in which patients had an ICD. No deaths, lead failures, losses of capture, or ventricular arrhythmias occurred during MRI. One ICD generator could not be interrogated after MRI and required immediate replacement; the device had not been appropriately programmed per protocol before the MRI. We observed six cases of self-terminating atrial fibrillation or flutter and six cases of partial electrical reset. Changes in lead impedance, pacing threshold, battery voltage, and P-wave and R-wave amplitude exceeded prespecified thresholds in a small number of cases. Repeat MRI was not associated with an increase in adverse events. In this study, device or lead failure did not occur in any patient with a non-MRI-conditional pacemaker or ICD who underwent clinically indicated nonthoracic MRI at 1.5 tesla, was appropriately screened, and had the device reprogrammed in accordance with the prespecified protocol. (Funded by St. Jude Medical and others; MagnaSafe ClinicalTrials.gov number, NCT00907361 .).

Tilted Implants for Full-Arch Rehabilitations in Completely Edentulous Maxilla: A Retrospective Study

PubMed Central

Cavalli, Nicolò; Barbaro, Bruno; Spasari, Davide; Azzola, Francesco; Ciatti, Alberto; Francetti, Luca

2012-01-01

Purpose. The aims of this study were to assess the treatment outcome of immediately loaded full-arch fixed bridges anchored to both tilted and axially placed implants in the edentulous maxilla and to evaluate the incidence of biological and prosthetic complications. Materials and Methods. Thirty-four patients (18 women and 16 men) were included in the study. Each patient received a maxillary full-arch fixed bridge supported by two axial implants and two distal tilted implants. A total of 136 implants were inserted. Loading was applied within 48 hours of surgery and definitive restorations were placed 4 to 6 months later. Patients were scheduled for followup at 6, 12, 18, and 24 months and annually up to 5 years. At each followup plaque level and bleeding scores were assessed and every complication was recorded. Results. The overall follow-up range was 12 to 73 months (mean 38.8 months). No implant failures were recorded to date, leading to a cumulative implant survival rate of 100%. Biological complications were recorded such as alveolar mucositis (11.8% patients), peri-implantitis (5.9% patients), and temporomandibular joint pain (5.9% patients). The most common prosthetic complications were the fracture or detachment of one or multiple acrylic teeth in both the temporary (20.6% patients) and definitive (17.7% patients) prosthesis and the minor acrylic fractures in the temporary (14.7% patients) and definitive (2.9% patients) prosthesis. Hygienic complications occurred in 38.2% patients. No patients' dissatisfactions were recorded. Conclusions. The high cumulative implant survival rate indicates that this technique could be considered a viable treatment option. An effective recall program is important to early intercept and correct prosthetic and biologic complications in order to avoid implant and prosthetic failures. PMID:23133453

Implant of permanent pacemaker during acute coronary syndrome: Mortality and associated factors in the ARIAM registry.

PubMed

Pola-Gallego-de-Guzmán, María Dolores; Ruiz-Bailén, Manuel; Martínez-Arcos, Maria-Angeles; Gómez-Blizniak, Artur; Castillo Rivera, Ana-Maria; Molinos, Jesus Cobo

2018-04-01

Patients with acute coronary syndrome complicated with high degree atrioventricular block still have a high mortality. A low percentage of these patients need a permanent pacemaker (PPM) but mortality and associated factors with the PPM implant in acute coronary syndrome patients are not known. We assess whether PPM implant is an independent variable in the mortality of acute coronary syndrome patients. Also, we explored the variables that remain independently associated with PPM implantation. This was an observational study on the Spanish ARIAM register. The inclusion period was from January 2001 to December 2011. This registry included all Andalusian acute coronary syndrome patients. Follow-up for global mortality was until November 2013. We selected 27,608 cases. In 62 patients a PPM was implanted (0.024%). The mean age in PPM patients was 70.71±11.214 years versus 64.46±12.985 years in patients with no PPM. PPM implant was associated independently with age (odds ratio (OR) 1.031, 95% confidence interval (CI) 1.007-1.055), with left ventricular branch block (OR 6.622, 95% CI 2.439-18.181), with any arrhythmia at intensive care unit admission (OR 2.754, 95% CI 1.506-5.025) and with heart failure (OR 3.344, 95% CI 1.78-8.333). PPM implant was independently associated with mortality (OR 11.436, 95% CI 1.576-83.009). In propensity score analysis PPM implant was still associated with mortality (OR 5.79, 95% CI 3.27-25.63). PPM implant is associated with mortality in the acute coronary syndrome population in the ARIAM registry. Advanced age, heart failure, arrhythmias and left ventricular branch block at intensive care unit admission were found associated factors with PPM implant in acute coronary syndrome patient.

Protracted treatment with corticosterone reduces breeding success in a long-lived bird.

PubMed

Nelson, Bethany F; Daunt, Francis; Monaghan, Pat; Wanless, Sarah; Butler, Adam; Heidinger, Britt J; Newell, Mark; Dawson, Alistair

2015-01-01

Determining the physiological mechanisms underpinning life-history decisions is essential for understanding the constraints under which life-history strategies can evolve. In long-lived species, where the residual reproductive value of breeders is high, adult survival is a key contributor to lifetime reproductive success. We therefore expect that when adult survival is compromised during reproduction, mechanisms will evolve to redirect resources away from reproduction, with implications for reproductive hormones, adult body mass, nest attendance behaviour and breeding success. We investigated whether manipulating corticosterone, to simulate exposure to an environmental stressor, affected the secretion of prolactin and breeding success in the black-legged kittiwake Rissa tridactyla. We used implanted Alzet® osmotic pumps to administer corticosterone to incubating kittiwakes at a constant rate over a period of approximately 8days. Manipulated birds were compared with sham implanted birds and control birds, which had no implants. There was no significant difference in the body mass of captured individuals at the time of implantation and implant removal. Corticosterone-implanted males showed lower nest attendance during the chick rearing period compared to sham-implanted males; the opposite pattern was found in females. Corticosterone treated birds showed a marginally significant reduction in breeding success compared to sham-implanted individuals, with all failures occurring at least 1week after implant removal. However, prolactin concentrations at implant removal were not significantly different from initial values. We were unable to measure the profile of change in corticosterone during the experiment. However, our results suggest a delayed effect of elevated corticosterone on breeding success rather than an immediate suppression of prolactin concentrations causing premature failure. Copyright © 2014 Elsevier Inc. All rights reserved.

Failure mode and effects analysis drastically reduced potential risks in clinical trial conduct

PubMed Central

Baik, Jungmi; Kim, Hyunjung; Kim, Rachel

2017-01-01

Background Failure mode and effects analysis (FMEA) is a risk management tool to proactively identify and assess the causes and effects of potential failures in a system, thereby preventing them from happening. The objective of this study was to evaluate effectiveness of FMEA applied to an academic clinical trial center in a tertiary care setting. Methods A multidisciplinary FMEA focus group at the Seoul National University Hospital Clinical Trials Center selected 6 core clinical trial processes, for which potential failure modes were identified and their risk priority number (RPN) was assessed. Remedial action plans for high-risk failure modes (RPN >160) were devised and a follow-up RPN scoring was conducted a year later. Results A total of 114 failure modes were identified with an RPN score ranging 3–378, which was mainly driven by the severity score. Fourteen failure modes were of high risk, 11 of which were addressed by remedial actions. Rescoring showed a dramatic improvement attributed to reduction in the occurrence and detection scores by >3 and >2 points, respectively. Conclusions FMEA is a powerful tool to improve quality in clinical trials. The Seoul National University Hospital Clinical Trials Center is expanding its FMEA capability to other core clinical trial processes. PMID:29089745

Low-level laser therapy with 940 nm diode laser on stability of dental implants: a randomized controlled clinical trial.

PubMed

Torkzaban, Parviz; Kasraei, Shahin; Torabi, Sara; Farhadian, Maryam

2018-02-01

Low-level laser therapy (LLLT) is a non-invasive modality to promote osteoblastic activity and tissue healing. The aim of this study was to evaluate the efficacy of LLLT for improvement of dental implant stability. This randomized controlled clinical trial was performed on 80 dental implants placed in 19 patients. Implants were randomly divided into two groups (n = 40). Seven sessions of LLLT (940 nm diode laser) were scheduled for the test group implants during 2 weeks. Laser was irradiated to the buccal and palatal sides. The same procedure was performed for the control group implants with laser hand piece in "off" mode. Implant stability was measured by Osstell Mentor device in implant stability quotient (ISQ) value immediately after surgery and 10 days and 3, 6, and 12 weeks later. Repeated measures ANOVA was used to compare the mean ISQ values (implant stability) in the test and control groups. Statistical test revealed no significant difference in the mean values of implant stability between the test and control groups over time (P = 0.557). Although the mean values of implant stability changed significantly in both groups over time (P < 0.05). Although the trend of reduction in stability was slower in the laser group in the first weeks and increased from the 6th to 12th week, LLLT had no significant effect on dental implant stability.

Prevalence and mechanism of tricuspid regurgitation following implantation of endocardial leads for pacemaker or cardioverter-defibrillator.

PubMed

Al-Mohaissen, Maha A; Chan, Kwan Leung

2012-03-01

Endocardial lead-induced tricuspid regurgitation has not been well recognized, either clinically or echocardiographically, and yet it is likely a preventable iatrogenic disease. In severe cases, it can lead to right ventricular failure and require tricuspid valve surgery. This complication will become increasingly important, because the numbers of permanent pacemakers and implantable cardioverter-defibrillators are expected to increase because of the aging population and the expanding capabilities of these devices. Published studies are largely retrospective, and serial studies to assess the time course of the development of tricuspid regurgitation are lacking. The mechanisms and severity of tricuspid regurgitation may not be well evaluated by two-dimensional echocardiography. Real-time three-dimensional echocardiography appears to be a promising technique to evaluate the mechanism of tricuspid regurgitation and may allow the early detection of patients who will develop severe lead-induced tricuspid regurgitation. A better understanding of the mechanism of lead-induced tricuspid regurgitation will be essential to the development of preventive strategies, which can then be tested in future clinical trials. Copyright © 2012 American Society of Echocardiography. Published by Mosby, Inc. All rights reserved.

Cancellous and cortical bone mineral density around an elastic press-fit socket in total hip arthroplasty.

PubMed

Pakvis, Dean F M; Heesterbeek, Petra J C; Severens, Marianne; Spruit, Maarten

2016-12-01

Background and purpose - The acetabular component has remained the weakest link in hip arthroplasty for achievement of long-term survival. One of the possible explanatory factors for acetabular failure has been acetabular stress shielding. For this, we investigated the effects of a cementless elastic socket on acetabular bone mineral density (BMD). Patients and methods - During 2008-2009, we performed a single-center prospective cohort trial on 25 patients (mean age 64 (SD 4), 18 females) in whom we implanted a cementless elastic press-fit socket. Using quantitative BMD measurements on CT, we determined the change in BMD surrounding the acetabular component over a 2-year follow-up period. Results - We found a statistically significant decrease in cancellous BMD (-14% to -35%) and a stable level of cortical BMD (5% to -5%) surrounding the elastic press-fit cup during the follow-up period. The main decrease was seen during the first 6 months after implantation. During the second year, cancellous BMD showed a further decrease in the medial and lower acetabular regions. Interpretation - We found no evidence that an elastic press-fit socket would prevent acetabular stress shielding during a 2-year follow-up.

Reporting quality of randomised controlled trials published in prosthodontic and implantology journals.

PubMed

Kloukos, D; Papageorgiou, S N; Doulis, I; Petridis, H; Pandis, N

2015-12-01

The purpose of this study was to examine the reporting quality of randomised controlled trials (RCTs) published in prosthodontic and implantology journals. Thirty issues of nine journals in prosthodontics and implant dentistry were searched for RCTs, covering the years 2005-2012: The Journal of Prosthetic Dentistry, Journal of Oral Rehabilitation, The International Journal of Prosthodontics, The International Journal of Periodontics & Restorative Dentistry, Clinical Oral Implants Research, Clinical Implant Dentistry & Related Research, The International Journal of Oral & Maxillofacial Implants, Implant Dentistry and Journal of Dentistry. The reporting quality was assessed using a modified Consolidated Standards of Reporting Trials (CONSORT) statement checklist. Data were analysed using descriptive statistics followed by univariable and multivariable examination of statistical associations (α = 0·05). A total of 147 RCTs were identified with a mean CONSORT score of 69·4 (s.d. = 9·7). Significant differences were found among journals with the Journal of Oral Rehabilitation achieving the highest score (80·6, s.d. = 5·5) followed by Clinical Oral Implants Research (73·7, s.d. = 8·3). Involvement of a statistician/methodologist was significantly associated with increased CONSORT scores. Overall, the reporting quality of RCTs in major prosthodontic and implantology journals requires improvement. This is of paramount importance considering that optimal reporting of RCTs is an important prerequisite for clinical decision-making. © 2015 John Wiley & Sons Ltd.

PIP silicone breast implants: rupture rates based on the explantation of 676 implants in a single surgeon series.

PubMed

Quaba, Omar; Quaba, Awf

2013-09-01

To determine the true rupture rates of PIP implants from a large single surgeon cohort and to assess whether rupture rates varied depending on time of implant insertion. In addition, the efficacy of ultra sound scanning (USS) in determining rupture is examined. Predominantly prospectively based analysis of patient records, investigations and surgical findings. 338 patients (676 implants) were included in the study and they all had removal of their implants. The senior author operated on all patients at some stage of their treatment. 160 patients were imaged pre-operatively with USS. Patients had implants inserted between 1999 and 2007 for cosmetic breast augmentation. A total of 144 ruptured implants were removed from 119 patients, giving a rupture rate of 35.2% per patient and 21.3% per implant over a mean implantation period of 7.8 years. A statistical difference (P < 0.001) in rupture rates between implants inserted prior to 2003 and those inserted from 2003 was demonstrated, with higher failure rates in the latter group. There was a significant difference in rupture rates depending on pocket placement of the implants. The sensitivity and specificity of USS at detecting rupture was 90.6% and 98.3% respectively. A proportion of patients (29.4%) demonstrated loco-regional spread of silicone to the axilla on scanning. Our paper has confirmed high rates of PIP implant failure in the largest published series to date. The significant difference in rupture rates between implants inserted prior to 2003 and those after this time supports the view that industrial silicone was used in the devices after 2003. Implants are more likely to rupture if inserted in the sub muscular plane compared to the sub glandular plane. USS is highly effective at detecting rupture in PIP implants and loco-regional spread is high compared to other devices. We believe this paper provides hard data enabling more informed decision making for patients, clinicians and providers in what remains an active issue affecting thousands of women. Copyright © 2013 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

"Pseudo" Faraday cage: a solution for telemetry link interaction between a left ventricular assist device and an implantable cardioverter defibrillator.

PubMed

Jacob, Sony; Cherian, Prasad K; Ghumman, Waqas S; Das, Mithilesh K

2010-09-01

Patients implanted with left ventricular assist devices (LVAD) may have implantable cardioverter defibrillators (ICD) implanted for sudden cardiac death prevention. This opens the possibility of device-device communication interactions and thus interferences. We present a case of such interaction that led to ICD communication failure following the activation of an LVAD. In this paper, we describe a practical solution to circumvent the communication interference and review the communication links of ICDs and possible mechanisms of ICD-LVAD interactions.