Identification of complications in mastectomy with immediate reconstruction using tissue expanders and permanent implants for breast cancer patients.

PubMed

Ota, Daisuke; Fukuuchi, Atsushi; Iwahira, Yoshiko; Kato, Takao; Takeuchi, Masashi; Okamoto, Joji; Nishi, Tsunehiro

2016-05-01

Since complications of postmastectomy breast reconstruction may reduce patient satisfaction, we investigated complications of reconstruction with tissue expanders (TEs), particularly surgical site infections requiring TE/permanent implant (PI) removal. A retrospective review was performed of 234 primary breast cancer patients undergoing 239 postmastectomy breast reconstructions with TEs/PIs from 1997 to 2009. Clinicopathological findings and postoperative complications, particularly infections, were analyzed. Data were analyzed by the Chi-square test and a multivariate logistic regression model. TE infection risk factors considered for model inclusion were excisional biopsy, (neo) adjuvant chemotherapy, lymph node resection, body mass index (BMI), simultaneous bilateral reconstructions, and seroma aspiration. Removal of TEs/PIs was observed in 15.5% (37/239) of reconstructions, and 18/37 underwent re-reconstructions. Of the 19/37 reconstructions that were not achieved completely, the most frequent reason was TE infection (11 reconstructions). The completion rate was 92% (220/239 reconstructions) and it was significantly higher in reconstructions without TE infection than with infection (96 vs. 54%, p < 0.0001). Patients with BMI ≥ 25 kg/m² and seroma aspiration were more likely to develop TE infections (p = 0.0019, p < 0.001, respectively). By multivariate logistic regression analysis, seroma aspiration was a significant independent risk factor for TE infection (odds ratio 28.75, 95% confidence interval 5.71-40.03, p < 0.0001). To improve completion rates of breast reconstruction, prevention of TE infection plays a key role. We should reduce unnecessary seroma aspirations and delay elevation/exercise of the ipsilateral arm.

Transfemoral access when superior venous approach is not feasible equals overall success of permanent pacemaker implantation. Ten-year series.

PubMed

García Guerrero, Juan J; Fernández de la Concha Castañeda, Joaquín; Doblado Calatrava, Manuel; Redondo Méndez, Ángel; Lázaro Medrano, Manuel; Merchán Herrera, Antonio

2017-06-01

When permanent pacemaker implantation is not possible or advisable via superior venous access (i.e., axillary or subclavian veins), safe and feasible surgical alternatives are required. The femoral approach is relatively unknown and seldom studied. This single-center study analyzed 10-year outcomes of a femoral implantation approach. Data about the implantation procedure (indication, approach, lead and pacemaker models, complications), patient characteristics (age, sex, medications, comorbidities), and follow-up were analyzed for all permanent pacemaker implantations using the femoral approach between June 2001 and June 2011. A permanent pacemaker was implanted with the femoral approach in 50 patients (mean age, 76 years [range: 45-96], 31 [61%] men). The most frequent indication was atrioventricular block, associated with sinus rhythm in 30 patients and with atrial fibrillation in eight patients. Overall, 20 patients (40%) were treated with oral anticoagulants postimplantation. Mean implantation time was 64 minutes (range: 20-210) and mean fluoroscopy time was 6.7 minutes (range: 0.2-50). Minimum follow-up window was 1 year (June 2012), with a mean of 50 months [range: 1-113]). No deaths, septic episodes, or severe complications were associated with the procedure, acute or long-term. Follow-up data were available for 46 patients, of who 21 (46%) died during follow-up (mean age, 87 years [range: 73-101]). No cause of death was associated with the femoral technique. Permanent pacemaker implantation through femoral access is not difficult for an experienced implant surgeon. Outcomes were comparable to systems implanted by superior venous approach, and no severe complications were observed at 10-year follow-up. © 2017 Wiley Periodicals, Inc.

Predictors of Need for Permanent Pacemaker Implantation and Conduction Abnormalities With a Novel Self-expanding Transcatheter Heart Valve.

PubMed

Pellegrini, Costanza; Husser, Oliver; Kim, Won-Keun; Holzamer, Andreas; Walther, Thomas; Rheude, Tobias; Mayr, Nicola Patrick; Trenkwalder, Teresa; Joner, Michael; Michel, Jonathan; Chaustre, Fabian; Kastrati, Adnan; Schunkert, Heribert; Burgdorf, Christof; Hilker, Michael; Möllmann, Helge; Hengstenberg, Christian

2018-03-15

The incidence of permanent pacemaker implantation (PPI) and new conduction abnormalities (CA) with the ACURATE neo (Symetis S.A., Eclubens, Switzerland) has not been studied in detail. We aimed to analyze their predictors, evaluating patient- and device-related factors, including implantation depth and device-to-annulus ratio (DAR). Two analyses of a multicenter population were performed: new PPI in pacemaker-naive patients (n = 283), and PPI/new-CA in patients without prior CA or pacemaker (n = 232). A new PPI was required in 9.9% of patients, who had a higher body mass index, higher rate of right bundle branch block and bradycardia. Neither implantation depth nor DAR differed in patients with PPI compared with those without. In the multivariable analysis neither DAR (OR, 1.010; 95%CI, 0.967-1.055; P = .7) nor implantation depth (OR, 0.972; 95%CI, 0.743-1.272; P = .8) predicted PPI. Only high body mass index, bradycardia and right bundle branch block persisted as independent predictors. PPI/new-onset CA occurred in 22.8% of patients and was associated with a higher logistic EuroSCORE. Neither implantation depth nor DAR differed in patients with PPI/new-CA vs those without (7.3 ± 1.9 vs 7.1 ± 1.5mm; P = .6 and 41.0 ± 7.9 vs 42.2 ± 10.1%; P = .4). The only predictor of PPI/new-CA was a higher logistic EuroSCORE (OR, 1.039; 95%CI, [1.008-1.071]; P = .013). New PPI and new-onset CA rates were low with the ACURATE neo. These were mainly influenced by patient characteristics and not by device-depending factors. Copyright © 2018 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

Risk Factors for Permanent Pacemaker after Implantation of Surgical or Percutaneous Self-Expanding Aortic Prostheses.

PubMed

Villa, Emmanuel; Clerici, Alberto; Messina, Antonio; Testa, Luca; Bedogni, Francesco; Moneta, Andrea; Donatelli, Francesco; Troise, Giovanni

2016-11-01

The use of transcatheter aortic valve implantation (TAVI) following the introduction of Nitinol autoexpandable devices has spread rapidly during recent years. In addition, cardiac surgery has been revolutionized due to the use of Nitinol-based sutureless prostheses for aortic valve replacement (AVR). During the same period, however, permanent pacemaker (PPM) implantation has emerged as a frequent complication. The study aim was to identify the risk factors of PPM following the implantation of a Nitinol self-expanding prosthesis (for AVR or TAVI). A study group was created between two institutions experienced in the use of nitinol devices, and a pool of 336 patients (56.6% CoreValve - Medtronic; 43.4% Perceval - Sorin) was available for a retrospective analysis. Pre-procedural clinical and electrocardiography (ECG) variables and postprocedural ECG variables were compared between the PPM group and control patients who had not received a PPM during their index hospitalization. A PPM was required in 12.8% of patients (TAVI 17.5% versus AVR 6.8%, p = 0.007). PPM patients had a higher logistical EuroSCORE (median 20.77% versus 15.59%, p = 0.015), a lower use of statins (18.6% versus 34.2%, p = 0.04), a pre-procedural longer QRS interval (median 117 ms versus 98 ms, p = 0.002), and a higher incidence of conduction disturbances (29.3% versus 16.8%, p = 0.034), with a prevalence of right bundle branch block. At the first postprocedural ECG, non-stimulated PPM patients had a longer QRS interval (median 150 ms versus 113 ms, p<0.001) and a longer QTc interval (487.3 ± 46 ms versus 510.8 ± 53.8 ms, p = 0.005). Prevalent intra-ventricular conduction disorders in both groups included left bundle branch block. AVR patients received a PPM later than the TAVI group (median 6 days versus 3 days, p = 0.01). TAVI was an independent predictor of PPM at logistic regression analysis (OR 3.18; 95% CI 1.19-8.48, p = 0.021), but the significance disappeared after incorporating post-procedural ECG variables. Nitinol technology is a ground-breaking option for aortic valve procedures. However, the radial forces of the self-expandable mechanism may be implicated in the increased need for PPM, mostly in cases of TAVI compared to AVR, that most likely are due to displacement of the stent provoked by in situ calcium clusters. Given the clinical and economic impact of PPM, new parameters are required to understand the stent/tissue interaction and to help with device selection.

Radiation and depression associated with complications of tissue expander reconstruction.

PubMed

Chuba, Paul J; Stefani, William A; Dul, Carrie; Szpunar, Susan; Falk, Jeffrey; Wagner, Rachael; Edhayan, Elango; Rabbani, Anna; Browne, Cynthia H; Aref, Amr

2017-08-01

Rates of implant failure, wound healing delay, and infection are higher in patients having radiation therapy (RT) after tissue expander (TE) and permanent implant reconstruction. We investigated pretreatment risk factors for TE implant complications. 127 breast cancer patients had TE reconstruction and radiation. For 85 cases of bilateral TE reconstruction, the non-irradiated breast provided an internal control. Comparison of differences in means for continuous variables used analysis of variance, then multiple pairwise comparisons with Bonferroni correction of p value. Mean age was 53 ± 10.1 years with 14.6% African-American. Twelve (9.4%) were BRCA positive (9 BRCA1, 4 BRCA2, 1 Both). Complications were: Grade 0 (no complication; 43.9%), Grade 1 (tightness and/or drifting of implant or Baker Grade II capsular contracture; 30.9%), Grade 2 (infection, hypertrophic scarring, or incisional necrosis; 9.8%), Grade 3 (Baker Grade III capsular contracture, wound dehiscence, or impending exposure of implant; 5.7%), Grade 4 (implant failure, exchange of implant, or Baker Grade IV capsular contracture; 9.8%). 15.3% (19 cases) experienced Grade 3 or 4 complication and 9.8% (12 cases) had Grade 4 complication. Considering non-irradiated breasts, there were two (1.6%) Grade 3-4 complications. For BMI, there was no significant difference by category as defined by the CDC (p = 0.91). Patients with depression were more likely to experience Grade 3 or 4 complication (29.4 vs 13.2%; p = 0.01). Using multiple logistic regression to predict the probability of a Grade 3 or 4 complications in patients with depression were found to be 4.2 times more likely to have a Grade 3 or 4 complication (OR = 4.2, p = 0.03). Higher rates of TE reconstruction complications are expected in patients receiving radiotherapy. An unexpected finding was that patients reporting medical history of depression showed statistically significant increase in complication rates.

Pacemaker dependency after transcatheter aortic valve implantation with the self-expanding Medtronic CoreValve System.

PubMed

van der Boon, Robert M A; Van Mieghem, Nicolas M; Theuns, Dominic A; Nuis, Rutger-Jan; Nauta, Sjoerd T; Serruys, Patrick W; Jordaens, Luc; van Domburg, Ron T; de Jaegere, Peter P T

2013-09-30

To determine pacemaker (PM) dependency at follow-up visit in patients who underwent new permanent pacemaker implantation (PPI) following transcatheter aortic valve implantation (TAVI). Single center prospective observational study including 167 patients without previous PM implantation who underwent TAVI with the self-expanding Medtronic CoreValve System (MCS) between November 2005 and February 2011. PM dependency was defined by the presence of a high degree atrioventricular block (HDAVB; second [AV2] and third degree [AV3B]), or a slow (<30 bpm) or absent ventricular escape rhythm during follow-up PM interrogation. A total of 36 patients (21.6%) received a new PM following TAVI. The indication for PM was AV2B (n=2, 5.6%), AV3B (n=28, 77.8%), postoperative symptomatic bradycardia (n=3, 8.3%), brady-tachy syndrome (n=1, 2.8%), atrial fibrilation with slow response (n=1, 2.8%) and left bundle branch block (n=1, 2.8%). Long term follow-up was complete for all patients and ranged from 1 to 40 months (median (IQR): 11.5 (5.0-18.0 months). Of those patients with a HDAVB, 16 out of the 30 patients (53.3%) were PM independent at follow-up visit (complete or partial resolution of the AV conduction abnormality). Overall, 20 out of the 36 patients (55.6%) who received a new PM following TAVI were PM independent at follow-up. Partial and even complete resolution of peri-operative AV conduction abnormalities after MCS valve implantation occurred in more than half of the patients. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Use of Retrievable Compared to Permanent Inferior Vena Cava Filters: A Single-Institution Experience

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

Ha, Thuong G. Van; Chien, Andy S.; Funaki, Brian S.

The purpose of this study was to review the use, safety, and efficacy of retrievable inferior vena cava (IVC) filters in their first 5 years of availability at our institution. Comparison was made with permanent filters placed in the same period. A retrospective review of IVC filter implantations was performed from September, 1999, to September, 2004, in our department. These included both retrievable and permanent filters. The Recovery nitinol and Guenther tulip filters were used as retrievable filters. The frequency of retrievable filter used was calculated. Clinical data and technical data related to filter placement were reviewed. Outcomes, including pulmonarymore » embolism, complications associated with placement, retrieval, or indwelling, were calculated. During the study period, 604 IVC filters were placed. Of these, 97 retrievable filters (16%) were placed in 96 patients. There were 53 Recovery filter and 44 Tulip filter insertions. Subjects were 59 women and 37 men; the mean age was 52 years, with a range of from 18 to 97 years. The placement of retrievable filters increased from 2% in year 1 to 32% in year 5 of the study period. The total implantation time for the permanent group was 145,450 days, with an average of 288 days (range, 33-1811 days). For the retrievable group, the total implantation time was 21,671 days, with an average of 226 days (range, 2-1217 days). Of 29 patients who returned for filter retrieval, the filter was successfully removed in 28. There were 14 of 14 successful Tulip filter retrievals and 14 of 15 successful Recovery filter retrievals. In one patient, after an indwelling period of 39 days, a Recovery nitinol filter could not be removed secondary to a large clot burden within the filter. For the filters that were removed, the mean dwell time was 50 days for the Tulip type and 20 days for the Recovery type. Over the follow-up period there was an overall PE incidence of 1.4% for the permanent group and 1% for the retrieval group. In conclusion, there was an increase in the use of retrievable filters over the study period and an overall increase in the total number of filters implanted. The increased use of these filters appeared to be due to expanded indications predicated by their retrievability. Placement and retrieval of these filters have a low risk of complications, and retrievable filters appeared effective, as there was low rate of clinically significant pulmonary embolism associated with these filters during their indwelling time.« less

Inverse Relationship Between Membranous Septal Length and the Risk of Atrioventricular Block in Patients Undergoing Transcatheter Aortic Valve Implantation.

PubMed

Hamdan, Ashraf; Guetta, Victor; Klempfner, Robert; Konen, Eli; Raanani, Ehud; Glikson, Michael; Goitein, Orly; Segev, Amit; Barbash, Israel; Fefer, Paul; Spiegelstein, Dan; Goldenberg, Ilan; Schwammenthal, Ehud

2015-08-17

This study sought to examine whether imaging of the atrioventricular (AV) membranous septum (MS) by computed tomography (CT) can be used to identify patient-specific anatomic risk of high-degree AV block and permanent pacemaker (PPM) implantation before transcatheter aortic valve implantation (TAVI) with self-expandable valves. MS length represents an anatomic surrogate of the distance between the aortic annulus and the bundle of His and may therefore be inversely related to the risk of conduction system abnormalities after TAVI. Seventy-three consecutive patients with severe aortic stenosis underwent contrast-enhanced CT before TAVI. The aortic annulus, aortic valve, and AV junction were assessed, and MS length was measured in the coronal view. In 13 patients (18%), high-degree AV block developed, and 21 patients (29%) received a PPM. Multivariable logistic regression analysis revealed MS length as the most powerful pre-procedural independent predictor of high-degree AV block (odds ratio [OR]: 1.35, 95% confidence interval [CI]: 1.1 to 1.7, p = 0.01) and PPM implantation (OR: 1.43, 95% CI: 1.1 to 1.8, p = 0.002). When taking into account pre- and post-procedural parameters, the difference between MS length and implantation depth emerged as the most powerful independent predictor of high-degree AV block (OR: 1.4, 95% CI: 1.2 to 1.7, p < 0.001), whereas the difference between MS length and implantation depth and calcification in the basal septum were the most powerful independent predictors of PPM implantation (OR: 1.39, 95% CI: 1.2 to 1.7, p < 0.001 and OR: 4.9, 95% CI: 1.2 to 20.5, p = 0.03; respectively). Short MS, insufficient difference between MS length and implantation depth, and the presence of calcification in the basal septum, factors that may all facilitate mechanical compression of the conduction tissue by the implanted valve, predict conduction abnormalities after TAVI with self-expandable valves. CT assessment of membranous septal anatomy provides unique pre-procedural information about the patient-specific propensity for the risk of AV block. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Effects of silicone expanders and implants on echocardiographic image quality after breast reconstruction.

PubMed

Pignatti, Marco; Mantovani, Francesca; Bertelli, Luca; Barbieri, Andrea; Pacchioni, Lucrezia; Loschi, Pietro; De Santis, Giorgio

2013-08-01

Use of silicone expanders and implants is the most common breast reconstruction technique after mastectomy. Postmastectomy patients often need echocardiographic monitoring of potential cardiotoxicity induced by cancer chemotherapy. The impairment of the echocardiographic acoustic window caused by silicone implants for breast augmentation has been reported. This study investigates whether the echocardiographic image quality was impaired in women reconstructed with silicone expanders and implants. The records of 44 consecutive women who underwent echocardiographic follow-up after breast reconstruction with expanders and implants at the authors' institution from January of 2000 to August of 2012 were reviewed. The population was divided into a study group (left or bilateral breast expanders/implants, n=30) and a control group (right breast expanders/implants, n=14). The impact of breast expanders/implants on echocardiographic image quality was tested (analysis of covariance model). Patients with a breast expander/implant (left or bilateral and right breast expanders/implants) were included. The mean volume of the breast devices was 353.2±125.5 cc. The quality of the echocardiographic images was good or sufficient in the control group; in the study group, it was judged as adequate in only 50 percent of cases (15 patients) and inadequate in the remaining 15 patients (p<0.001). At multivariable analysis, a persistent relationship between device position (left versus right) and image quality (p=0.001) was shown, independent from other factors. Silicone expanders and implants in postmastectomy left breast reconstruction considerably reduce the image quality of echocardiography. This may have important clinical implications, given the need for periodic echocardiographic surveillance before and during chemotherapy. Therapeutic, III.

[Experimental study of PVPP/silicone composite automatic expanded material as implants].

PubMed

Yin, Wei-min; Gao, Jian-hua; Yang, Qing-fang; Lu, Feng; Ye, Jia-jia

2009-03-01

To study the feasibility of Polyvinylpolypyrrolidone (PVPP)/silicone composite automatic expanded material as implants. The PVPP hydrogel was mixed with silicone through the location at the high temperature. Implants with different ratio of PVPP to silicone were placed under the back and nose skin in 24 New Zealand rabbits. The surrounding tissue reaction, material and skin expansion were observed and compared with those with pure silicone implants. The study lasted for 200 days. Compared with pure silicone implants, the composite material could expand automatically and stop expanding at about 2 weeks after implantation. Histological study showed similar inflectional and foreign body reaction around the composite material and the pure silicone. Compared with pure silicone, the PVPP/silicone composite implant has the advantage of automatic expansion, so as to expand the soft tissue.

Photon counting readout pixel array in 0.18-μm CMOS technology for on-line gamma-ray imaging of 103palladium seeds for permanent breast seed implant (PBSI) brachytherapy

NASA Astrophysics Data System (ADS)

Goldan, A. H.; Karim, K. S.; Reznik, A.; Caldwell, C. B.; Rowlands, J. A.

2008-03-01

Permanent breast seed implant (PBSI) brachytherapy technique was recently introduced as an alternative to high dose rate (HDR) brachytherapy and involves the permanent implantation of radioactive 103Palladium seeds into the surgical cavity of the breast for cancer treatment. To enable accurate seed implantation, this research introduces a gamma camera based on a hybrid amorphous selenium detector and CMOS readout pixel architecture for real-time imaging of 103Palladium seeds during the PBSI procedure. A prototype chip was designed and fabricated in 0.18-μm n-well CMOS process. We present the experimental results obtained from this integrated photon counting readout pixel.

Postmastectomy Chest Wall Radiation to a Temporary Tissue Expander or Permanent Breast Implant-Is There a Difference in Complication Rates?

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

Anderson, Penny R.; Freedman, Gary; Nicolaou, Nicos

Purpose: The purpose of this study was to evaluate the likelihood of complications and cosmetic results among breast cancer patients who underwent modified radical mastectomy (MRM) and breast reconstruction followed by radiation therapy (RT) to either a temporary tissue expander (TTE) or permanent breast implant (PI). Methods and Materials: Records were reviewed of 74 patients with breast cancer who underwent MRM followed by breast reconstruction and RT. Reconstruction consisted of a TTE usually followed by exchange to a PI. RT was delivered to the TTE in 62 patients and to the PI in 12 patients. Dose to the reconstructed chestmore » wall was 50 Gy. Median follow-up was 48 months. The primary end point was the incidence of complications involving the reconstruction. Results: There was no significant difference in the rate of major complications in the PI group (0%) vs. 4.8% in the TTE group. No patients lost the reconstruction in the PI group. Three patients lost the reconstruction in the TTE group. There were excellent/good cosmetic scores in 90% of the TTE group and 80% of the PI group (p = 0.22). On multivariate regression models, the type of reconstruction irradiated had no statistically significant impact on complication rates. Conclusions: Patients treated with breast reconstruction and RT can experience low rates of major complications. We demonstrate no significant difference in the overall rate of major or minor complications between the TTE and PI groups. Postmastectomy RT to either the TTE or the PI should be considered as acceptable treatment options in all eligible patients.« less

Does the presence of an implant including expander with internal port alter radiation dose? An ex vivo model.

PubMed

Strang, Barbara; Murphy, Kyla; Seal, Shane; Cin, Arianna Dal

2013-01-01

There is a lack of literature examining the dosimetric implications of irradiating breast implants and expanders with internal ports inserted at the time of mastectomy. To determine whether the presence of breast expanders with port in saline or silicone implants affect the dose uniformity across the breast when irradiated with various photon and electron energies. One tissue-equivalent torso phantom with overlying tissue expanders in saline or silicone implants were irradiated using tangential fields with 6 MV and 18 MV photons and 9 MeV and 12 MeV electrons. All dose measurements were performed using thermoluminescent dosimeters (TLDs). The TLDs were arranged around the port and the perimeters of either the expander, or saline or silicone implant. Comparisons of measured radiation doses, and between the expected and measured doses of radiation from the TLDs on each prosthesis, were performed. Data were analyzed using two-tailed t tests. There were no differences in TLD measurements between the expander and the saline implant for all energy modalities, and for the expected versus actual measurements for the saline implant. Higher than anticipated measurements were recorded for a significant number of TLD positions around the silicone implants. Radiation doses around saline implants or expanders with internal port were unaltered, whereas dose recordings for silicone implants were higher than predicted in the present laboratory/ex vivo study.

Conduction Abnormalities and Pacemaker Implantations After SAPIEN 3 Vs SAPIEN XT Prosthesis Aortic Valve Implantation.

PubMed

Husser, Oliver; Kessler, Thorsten; Burgdorf, Christof; Templin, Christian; Pellegrini, Costanza; Schneider, Simon; Kasel, Albert Markus; Kastrati, Adnan; Schunkert, Heribert; Hengstenberg, Christian

2016-02-01

Transcatheter aortic valve implantation is increasingly used in patients with aortic stenosis. Post-procedural intraventricular conduction abnormalities and permanent pacemaker implantations remain a serious concern. Recently, the Edwards SAPIEN 3 prosthesis has replaced the SAPIEN XT. We sought to determine the incidences of new-onset intraventricular conduction abnormalities and permanent pacemaker implantations by comparing the 2 devices. We analyzed the last consecutive 103 patients undergoing transcatheter aortic valve implantation with SAPIEN XT before SAPIEN 3 was used in the next 105 patients. To analyze permanent pacemaker implantations and new-onset intraventricular conduction abnormalities, patients with these conditions at baseline were excluded. Electrocardiograms were recorded at baseline, after the procedure, and before discharge. SAPIEN 3 was associated with higher device success (100% vs 92%; P=.005) and less paravalvular leakage (0% vs 7%; P<.001). The incidence of permanent pacemaker implantations was 12.6% (23 of 183) with no difference between the 2 groups (SAPIEN 3: 12.5% [12 of 96] vs SAPIEN XT: 12.6% [11 of 87]; P=.99). SAPIEN 3 was associated with a higher rate of new-onset intraventricular conduction abnormalities (49% vs 27%; P=.007) due to a higher rate of fascicular blocks (17% vs 5%; P=.021). There was no statistically significant difference in transient (29% [20 of 69] vs persistent 19% [12 of 64]; P=.168) left bundle branch blocks (28% [19 of 69] vs 17% [11 of 64]; P=.154) when SAPIEN 3 was compared with SAPIEN XT. We found a trend toward a higher rate of new-onset intraventricular conduction abnormalities with SAPIEN 3 compared with SAPIEN XT, although this did not result in a higher permanent pacemaker implantation rate. Copyright © 2015 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

ASPS clinical practice guideline summary on breast reconstruction with expanders and implants.

PubMed

Alderman, Amy; Gutowski, Karol; Ahuja, Amy; Gray, Diedra

2014-10-01

After reading this article, participants should be able to: 1. Understand the evidence regarding the timing of expander/implant breast reconstruction in the setting of radiation therapy. 2. Discuss the implications of a patient's risk factors for possible outcomes and complications of expander/implant breast reconstruction. 3. Implement proper prophylactic antibiotic protocols. 4. Use the guidelines to improve their own clinical outcomes and reduce complications. In March of 2013, the Executive Committee of the American Society of Plastic Surgeons approved an evidence-based guideline on breast reconstruction with expanders and implants, as developed by a guideline-specific work group commissioned by the society's Health Policy Committee. The guideline addresses ten clinical questions: patient education, immediate versus delayed reconstruction, risk factors, radiation therapy, chemotherapy, hormonal therapy, antibiotic prophylaxis, acellular dermal matrix, monitoring for cancer recurrence, and oncologic outcomes associated with implant-based reconstruction. The evidence indicates that patients undergoing mastectomy should be offered a preoperative referral to a plastic surgeon. Evidence varies regarding the association between postoperative complications and timing of postmastectomy expander/implant breast reconstruction. Evidence is limited regarding the optimal timing of expand/implant reconstruction in the setting of radiation therapy but suggests that irradiation to the expander or implant is associated with an increased risk of postoperative complications. Evidence also varies regarding the association between acellular dermal matrix and surgical complications in the setting of postmastectomy expander/implant reconstruction. Data support the use of an appropriate preoperative antibiotic, but antibiotics should be discontinued within 24 hours of the procedure, unless a surgical drain is present. Furthermore, postmastectomy expander/implant breast reconstruction does not adversely affect oncologic outcomes.

In-situ investigation of stress conditions during expansion of bare metal stents and PLLA-coated stents using the XRD sin(2)ψ-technique.

PubMed

Kowalski, Wolfgang; Dammer, Markus; Bakczewitz, Frank; Schmitz, Klaus-Peter; Grabow, Niels; Kessler, Olaf

2015-09-01

Drug eluting stents (DES) consist of platform, coating and drug. The platform often is a balloon-expandable bare metal stent made of the CoCr alloy L-605 or stainless steel 316 L. The function of the coating, typically a permanent polymer, is to hold and release the drug, which should improve therapeutic outcome. Before implantation, DES are compressed (crimped) to allow implantation in the human body. During implantation, DES are expanded by balloon inflation. Crimping, as well as expansion, causes high stresses and high strains locally in the DES struts, as well as in the polymer coating. These stresses and strains are important design criteria of DES. Usually, they are calculated numerically by finite element analysis (FEA), but experimental results for validation are hardly available. In this work, the X-ray diffraction (XRD) sin(2)ψ-technique is applied to in-situ determination of stress conditions of bare metal L-605 stents, and Poly-(L-lactide) (PLLA) coated stents. This provides a realistic characterization of the near-surface stress state and a validation option of the numerical FEA. XRD-results from terminal stent struts of the bare metal stent show an increasing compressive load stress in tangential direction with increasing stent expansion. These findings correlate with numerical FEA results. The PLLA-coating also bears increasing compressive load stress during expansion. Copyright © 2015 Elsevier Ltd. All rights reserved.

Does the presence of an implant including expander with internal port alter radiation dose? An ex vivo model

PubMed Central

Strang, Barbara; Murphy, Kyla; Seal, Shane; Cin, Arianna Dal

2013-01-01

BACKGROUND: There is a lack of literature examining the dosimetric implications of irradiating breast implants and expanders with internal ports inserted at the time of mastectomy. OBJECTIVE: To determine whether the presence of breast expanders with port in saline or silicone implants affect the dose uniformity across the breast when irradiated with various photon and electron energies. METHODS: One tissue-equivalent torso phantom with overlying tissue expanders in saline or silicone implants were irradiated using tangential fields with 6 MV and 18 MV photons and 9 MeV and 12 MeV electrons. All dose measurements were performed using thermoluminescent dosimeters (TLDs). The TLDs were arranged around the port and the perimeters of either the expander, or saline or silicone implant. Comparisons of measured radiation doses, and between the expected and measured doses of radiation from the TLDs on each prosthesis, were performed. Data were analyzed using two-tailed t tests. RESULTS: There were no differences in TLD measurements between the expander and the saline implant for all energy modalities, and for the expected versus actual measurements for the saline implant. Higher than anticipated measurements were recorded for a significant number of TLD positions around the silicone implants. CONCLUSIONS: Radiation doses around saline implants or expanders with internal port were unaltered, whereas dose recordings for silicone implants were higher than predicted in the present laboratory/ex vivo study. PMID:24431935

78 FR 41125 - Interim Enforcement Policy for Permanent Implant Brachytherapy Medical Event Reporting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-09

... Brachytherapy Medical Event Reporting AGENCY: Nuclear Regulatory Commission. ACTION: Policy statement; revision... medical events occurring under an NRC licensee's permanent implant brachytherapy program. This interim..., ``Adequacy of Medical Event Definitions in 10 CFR [Title 10 of the Code of Federal Regulations] 35.3045, and...

SU-F-J-157: Effect of Contouring Uncertainty in Post Implant Dosimetry of Low-Dose-Rate Prostate Permanent Seed Brachytherapy

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

Mashouf, S; Merino, T; Ravi, A

Purpose: There is strong evidence relating post-implant dosimetry for low-dose-rate (LDR) prostate seed brachytherapy to local control rates. The delineation of the prostate on CT images, however, represents a challenge due to the lack of soft tissue contrast in order to identify the prostate borders. This study aims at quantifying the sensitivity of clinically relevant dosimetric parameters to uncertainty in the contouring of prostate. Methods: CT images, post-op plans and contours of a cohort of patients (n=43) (low risk=55.8%, intermediate risk=39.5%, high risk=4.7%), who had received prostate seed brachytherapy, were imported into MIM Symphony treatment planning system. The prostate contoursmore » in post-implant CT images were expanded/contracted uniformly for margins of ±1.00 mm, ±2.00 mm, ±3.00 mm, ±4.00 mm and ±5.00 mm. The values for V100 and D90 were extracted from Dose Volume Histograms for each contour and compared. Results: Significant changes were observed in the values of D90 and V100 as well as the number of suboptimal plans for expansion or contraction margins of only few millimeters. Evaluation of coverage based on D90 was found to be less sensitive to expansion errors compared to V100. D90 led to a lower number of implants incorrectly identified with insufficient coverage for expanded contours which increases the accuracy of post-implant QA using CT images compared to V100. Conclusion: In order to establish a successful post implant QA for LDR prostate seed brachytherapy, it is necessary to identify the low and high thresholds of important dose metrics of the target volume such as D90 and V100. Since these parameters are sensitive to target volume definition, accurate identification of prostate borders would help to improve accuracy and predictive value of the post-implant QA process. In this respect, use of imaging modalities such as MRI where prostate is well delineated should prove useful.« less

Zero-fluoroscopy permanent pacemaker implantation using Ensite NavX system: Clinical viability or fanciful technique?

PubMed

Guo, Ping; Qiu, Jie; Wang, Yan; Chen, Guangzhi; Proietti, Riccardo; Fadhle, Al-Selmi; Zhao, Chunxia; Wen Wang, Dao

2018-02-01

Fluoroscopy is the imaging modality routinely used for cardiac device implantation and electrophysiological procedures. Due to the rising concern regarding the harmful effects of radiation exposure to both the patients and operation staffs, novel 3D mapping systems have been developed and implemented in electrophysiological procedure for the navigation of catheters inside the heart chambers. Their applicability in cardiac device implantation has been rarely reported. Our aim is to evaluate the feasibility and safety of permanent pacemaker implantation without fluoroscopy. From January 2012 to June 2016, six patients (50 ± 15 years, four of six were female, one of who was at the 25th week of gestation) who underwent permanent pacemaker implantation were included (zero-fluoroscopy group). Data from 20 consecutive cases of implantation performed under fluoroscopy guidance were chosen as a control group (fluoroscopy group). Total implantation procedure time for single-chamber pacemaker was 51.3 ± 13.1 minutes in the zero-fluoroscopy group and 42.6 ± 7.4 minutes in the fluoroscopy group (P  =  0.155). The implantation procedural time for a dual-chamber pacemaker was 88.3 ± 19.6 minutes and 67.3 ± 7.6 minutes in the zero-fluoroscopy and fluoroscopy groups (P  =  0.013), respectively. No complications were observed during the procedure and the follow-up in the two groups, and all pacemakers worked with satisfactory parameters. Ensite NavX system can be used as a reliable and safe zero-fluoroscopy approach for the implantation of single- or dual-chamber permanent pacemakers in specific patients, such as pregnant women or in extreme situations when the x-ray machine is not available. © 2017 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals, Inc.

Latissimus dorsi myocutaneous flap for breast reconstruction: bad rap or good flap?

PubMed

Perdikis, Galen; Koonce, Stephanie; Collis, George; Eck, Dustin

2011-01-01

This article serves to review latissimus dorsi myocutaneous flap as an option for breast reconstruction postmastectomy. Since the introduction of the latissimus dorsi myocutaneous flap in the late 1970s, its use has always been as a secondary technique, particularly after the development of the transverse rectus abdominus myocutaneous flap in the 1980s. A literature review of the history of latissimus dorsi myocutaneous flap utilized for breast reconstruction as well as a review of our institution's experience with latissimus dorsi myocutaneous flap and tissue expander placement was performed. There remains a paucity of published studies investigating latissimus dorsi myocutaneous flap for breast reconstruction. Most studies have small numbers and do not utilize tissue expanders. More recently several small studies have been published that show acceptably low complication rates with aesthetically pleasing outcomes when latissimus dorsi myocutaneous flap is employed with a tissue expander. At our institution, we have employed latissimus dorsi myocutaneous flap with tissue expander placement for both delayed and immediate reconstruction with subsequent replacement with a permanent implant with a capsular contraction rate of 10.5%. Our data and others more recently published demonstrate very acceptable capsular contracture rates and aesthetic outcomes, particularly when an expander is utilized. The latissimus dorsi myocutaneous flap remains an excellent choice for breast reconstruction with a low risk of complications.

Comparison of Reconstructive Outcomes in Breast Cancer Patients With Preexisting Subpectoral Implants: Implant-Sparing Mastectomy With Delayed Implant Exchange Versus Immediate Tissue Expander Reconstruction.

PubMed

Parabkaharan, Sangeetha; Melody, Megan; Trotta, Rose; Lleshi, Amina; Sun, Weihong; Smith, Paul D; Khakpour, Nazanin; Dayicioglu, Deniz

2016-06-01

Women who have undergone prior augmentation mammoplasty represent a unique subset of breast cancer patients with several options available for breast reconstruction. We performed a single institution review of surgical outcomes of breast reconstruction performed in patients with breast cancer with prior history of subpectoral breast augmentation. Institutional review board-approved retrospective review was conducted among patients with previously mentioned criteria treated at our institution between 2000 and 2014. Reconstructions were grouped into 2 categories as follows: (1) removal of preexisting subpectoral implant during mastectomy with immediate tissue expander placement and (2) implant-sparing mastectomy followed by delayed exchange to a larger implant. We reviewed demographics, tumor features, and reconstruction outcomes of these groups. Fifty-three patients had preexisting subpectoral implants. Of the 63 breast reconstructions performed, 18 (28.6%) had immediate tissue expander placed and 45 (71.4%) had implant-sparing mastectomy followed by delayed implant exchange. The groups were comparable based on age, body mass index, cancer type, tumor grade, TNM stage at presentation, and hormonal receptor status. No significant difference was noted between tumor margins or subsequent recurrence, mastectomy specimen weight, removed implant volume, volume of implant placed during reconstruction, or time from mastectomy to final implant placement. Rates of complications were significantly higher in the tissue expander group compared to the implant-sparing mastectomy group 7 (38.9%) versus 4 (8.9%) (P = 0.005). Implant-sparing mastectomy with delayed implant exchange in patients with preexisting subpectoral implants is safe and has fewer complications compared to tissue expander placement. There was no difference noted in the final volume of implant placed, time interval for final implant placement, or tumor margins.

Short- and long-term need for permanent pacemaker after transcatheter implantation of the Edwards Sapien aortic valve prosthesis.

PubMed

Moreno, Raúl; Calvo, Luis; Sánchez-Recalde, Angel; Galeote, Guillermo; Jiménez-Valero, Santiago; López, Teresa; Plaza, Ignacio; González-Davia, Rosa; Ramírez, Ulises; Mesa, Jose Maria; Moreno-Gomez, Isidro; López-Sendón, José-Luis

2015-11-01

A permanent pacemaker is frequently needed after transcatheter aortic valve implantation, but the available data are mainly on the CoreValve system. To evaluate the need for new permanent pacemaker after implantation of the Edwards Sapien device, as well as related factors. We included the first 100 patients treated with the Edwards Sapien device at our institution. Of these, 12 had a permanent pacemaker before the procedure, and thus our study population was the remaining 88 patients. A permanent pacemaker was indicated in eight patients (9.1%) during hospitalization or at 30 days. After discharge, another four patients needed a pacemaker (at 42 days and three, 18, and 30 months). Two variables were associated with the need for pacemaker during hospitalization: previous dialysis (13% vs. 1%, p=0.042) and complete right bundle branch block before the procedure (25% vs. 5%, p=0.032). More than one month after the procedure, the characteristics associated with the need for pacemaker were plasma creatinine level (2.5±1.7 vs. 1.3±0.6 mg/dl, p=0.001) and previous myocardial infarction (50% vs. 10%, p=0.013). The rate of pacemaker implantation with the Edwards Sapien device was 9.1%. Right bundle branch block and dialysis were associated with this complication.

WE-AB-BRA-11: Improved Imaging of Permanent Prostate Brachytherapy Seed Implants by Combining an Endorectal X-Ray Sensor with a CT Scanner

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

Steiner, J; Matthews, K; Jia, G

Purpose: To test feasibility of the use of a digital endorectal x-ray sensor for improved image resolution of permanent brachytherapy seed implants compared to conventional CT. Methods: Two phantoms simulating the male pelvic region were used to test the capabilities of a digital endorectal x-ray sensor for imaging permanent brachytherapy seed implants. Phantom 1 was constructed from acrylic plastic with cavities milled in the locations of the prostate and the rectum. The prostate cavity was filled a Styrofoam plug implanted with 10 training seeds. Phantom 2 was constructed from tissue-equivalent gelatins and contained a prostate phantom implanted with 18 strandsmore » of training seeds. For both phantoms, an intraoral digital dental x-ray sensor was placed in the rectum within 2 cm of the seed implants. Scout scans were taken of the phantoms over a limited arc angle using a CT scanner (80 kV, 120–200 mA). The dental sensor was removed from the phantoms and normal helical CT and scout (0 degree) scans using typical parameters for pelvic CT (120 kV, auto-mA) were collected. A shift-and add tomosynthesis algorithm was developed to localize seed plane location normal to detector face. Results: The endorectal sensor produced images with improved resolution compared to CT scans. Seed clusters and individual seed geometry were more discernable using the endorectal sensor. Seed 3D locations, including seeds that were not located in every projection image, were discernable using the shift and add algorithm. Conclusion: This work shows that digital endorectal x-ray sensors are a feasible method for improving imaging of permanent brachytherapy seed implants. Future work will consist of optimizing the tomosynthesis technique to produce higher resolution, lower dose images of 1) permanent brachytherapy seed implants for post-implant dosimetry and 2) fine anatomic details for imaging and managing prostatic disease compared to CT images. Funding: LSU Faculty Start-up Funding. Disclosure: XDR Radiography has loaned our research group the digital x-ray detector used in this work. CoI: None.« less

Permanent His-bundle pacing: a systematic literature review and meta-analysis.

PubMed

Zanon, Francesco; Ellenbogen, Kenneth A; Dandamudi, Gopi; Sharma, Parikshit S; Huang, Weijian; Lustgarten, Daniel L; Tung, Roderick; Tada, Hiroshi; Koneru, Jayanthi N; Bergemann, Tracy; Fagan, Dedra H; Hudnall, John Harrison; Vijayaraman, Pugazhendhi

2018-04-26

Permanent cardiac pacing of the His-bundle restores and retains normal electrical activation of the ventricles. Data on His-bundle pacing (HBP) are largely limited to small single-centre reports, and clinical benefits and risks have not been systematically examined. We sought to systematically examine published studies of patients undergoing permanent HBP and quantify the benefits and risks of the therapy. PubMed, Embase, and Cochrane Library were searched for full-text articles on permanent HBP. Clinical outcomes of interest included implant success rate, procedural and lead complications, pacing thresholds, QRS duration, and ejection fraction at follow-up, and mortality. Data were extracted and summarized. Where possible, meta-analysis of aggregate data was performed. Out of 2876 articles, 26 met the inclusion criteria representing 1438 patients with an implant attempt. Average age of patients was 73 years and 62.1% were implanted due to atrioventricular block. Overall average implant success rate was 84.8% and was higher with use of catheter-delivered systems (92.1%; P < 0.001). Average pacing thresholds were 1.71 V at implant and 1.79 V at >3 months follow-up; although, pulse widths varied at testing. Average left ventricular ejection fractions (LVEFs) were 42.8% at baseline and 49.5% at follow-up. There were 43 complications observed in 907 patients across the 17 studies that reported safety information. Among 26 articles of permanent HBP, the implant success rate averaged 84.8% and LVEF improved by an average of 5.9% during follow-up. Specific reporting of our clinical outcomes of interest varied widely, highlighting the need for uniform reporting in future HBP trials.

Permanent transvenous pacemaker implantation in an Ibizan hound cross with persistent atrial standstill

PubMed Central

MacAulay, Kevin

2002-01-01

An Ibizan hound cross was referred with a 1-year history of syncope and exercise intolerance. An electrocardiogram showed bradycardia and no P waves; atrial standstill was diagnosed. A permanent artificial endocardial pacemaker was implanted. The lead dislodged and was reimplanted into the right ventricular apex. Capture was once again achieved. PMID:12395764

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

Vajda, Zsolt, E-mail: Z.Vajda@klinikum-stuttgart.de; Guethe, Thomas, E-mail: T.Guethe@klinikum-stuttgart.de; Perez, Marta Aguilar, E-mail: M.Aguilar@klinikum-stuttgart.de

Stenting in intracranial atherosclerotic disease (ICAD) is increasingly debated, due to issues of procedural safety, technical efficacy, and in-stent recurrent stenoses (ISR). In the present study, feasibility, safety, and efficacy of angioplasty using a drug-eluting balloon (DEB) followed by the implantation of a self-expanding stent (Enterprise) were evaluated for the treatment of ICAD lesions. Fifty-two patients (median age: 71 years; range: 54-86 years; male/female ratio 37:15) underwent stenting of high-grade ICAD lesions between February 2010 and November 2011 in a single center. Angioplasty using a paclitaxel coated SeQuent Please (B. Braun, Germany) or DIOR (Eurocor, Germany) coronary PTCA balloon, followedmore » by the implantation of a self-expanding stent (Enterprise, Codman, USA) was performed in 54 lesions. Angiographic and clinical follow-up was performed at 6 and 12 weeks, 6 and 12 months, and yearly thereafter. Technical success rate, periprocedural complications, occurrence of recurrent ischemic symptoms, and the development of an ISR were analyzed. Angioplasty using a DEB followed by stent implantation was successfully performed in 44 (81 %) cases. DEB insertion failed in 19 % of the cases and angioplasty was finally performed using a conventional PTCA balloon. The combined procedure related permanent neurologic morbidity and mortality rate (stroke, ICH, and subarachnoid hemorrhage) at 30 days and beyond was 5 %. Angiographic and clinical follow-up were obtained in 33 (61 %) lesions in 32 patients. Recurrent stenosis was seen in one (3 %) lesion. Angioplasty and stenting using a DEB is safe and yields encouragingly low ISR rates. Further technical developments to improve lesion accessibility are, nevertheless, mandatory.« less

New-generation devices for transcatheter aortic valve implantation.

PubMed

Gatto, Laura; Biondi-Zoccai, Giuseppe; Romagnoli, Enrico; Frati, Giacomo; Prati, Francesco; Giordano, Arturo

2018-04-20

Transcatheter aortic valve implantation (TAVI) has overcome the pioneering phase and thanks to accrued clinical evidence has become a mainstay alternative to surgical aortic valve replacement (SAVR) in patients at high risk for post-operative complications. Despite these successes, TAVI remains a junior technology facing momentous developments in techniques and devices. Indeed, several new-generation devices for TAVI have become available in the last few years, including Acurate, Allegra, Evolut, Lotus, JenaValve, Portico, and SAPIEN3. Despite the inevitable setbacks, such as the one represented by DirectFlow, these new devices appear associated with comparative benefits, especially for minimal invasiveness, rates of permanent pacemaker implantation, and risk of residual aortic regurgitation. Indeed, no single device appears clearly better than the others, and a tailored and individualized approach should be sought in using these prostheses, taking into account operator and institutional expertise, on top of patient features. Few comparative effectiveness studies are available to date to guide decision making, and thus careful scrutiny is needed even in everyday clinical practice, especially if seeking to expand the current indications of TAVI. Further guidance will however come from long-term follow-up of completed studies and from results of ongoing trials.

Transvenous permanent pacemaker implantation in dextrocardia: technique, challenges, outcome, and a brief review of literature.

PubMed

Shenthar, Jayaprakash; Rai, Maneesh K; Walia, Rohit; Ghanta, Somasekhar; Sreekumar, Praveen; Reddy, Satish S

2014-09-01

Dextrocardia is a rare congenital anomaly. Pacemaker implantation in dextrocardia can be challenging because of the distorted anatomy and associated anomalies. The literature regarding implantation of pacemaker in dextrocardia is scarce. The study involved retrospective analysis of records of patients with dextrocardia who had undergone pacemaker implantation between January 2006 and July 2013 from a single centre. Six patients with dextrocardia (five males and one female) underwent permanent pacemaker implantation (PPI) between January 2006 and July 2013. Of them, three had situs solitus dextrocardia and three situs inversus dextrocardia. All three patients with situs solitus dextrocardia had associated corrected transposition of great arteries. The indication for pacemaker implantation was symptomatic complete atrioventricular (AV) block in four, high-grade AV block in one, and sinus node dysfunction in one patient. A favourable outcome was noted during a mean follow-up of 3.9 years (4 months to 7 years) with one patient needing a pulse generator replacement. Permanent pacemaker implantation in dextrocardia can be challenging because of the distorted anatomy. Use of a technique employing angiography to delineate chamber anatomy and relationship can assist the operator during such difficult PPIs. The medium- and long-term survival after a successful pacemaker implantation in dextrocardia is favourable. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

Dosimetric intercomparison of permanent Ho-166 seed's implants and HDR Ir-192 brachytherapy in breast cancer.

PubMed

de Campos, Tarcisio Passos Ribeiro; Nogueira, Luciana Batista; Trindade, Bruno; Cuperschmid, Ethel Mizrahy

2016-01-01

To provide a comparative dosimetric analysis of permanent implants of Ho(166)-seeds and temporary HDR Ir(192)-brachytherapy through computational simulation. Brachytherapy with Ir(192)-HDR or LDR based on temporary wires or permanent radioactive seed implants can be used as dose reinforcement for breast radiation therapy. Permanent breast implants have not been a practical clinical routine; although, I(125) and Pd(103)-seeds have already been reported. Biodegradable Ho(166)-ceramic-seeds have been addressed recently. Simulations of implants of nine Ho(166)-seeds and equivalent with HDR Ir(192)-brachytherapy were elaborated in MCNP5, shaped in a computational multivoxel simulator which reproduced a female thorax phantom. Spatial dose rate distributions and dose-volume histograms were generated. Protocol's analysis involving exposure time, seed's activities and dose were performed. Permanent Ho(166)-seed implants presented a maximum dose rate per unit of contained activity (MDR) of 1.1601 μGy h(-1) Bq(-1); and, a normalized MDR in standard points (8 mm, equidistant to 03-seeds - SP1, 10 mm - SP2) of 1.0% (SP1) and 0.5% (SP2), respectively. Ir(192)-brachytherapy presented MDR of 4.3945 × 10(-3) μGy h(-1) Bq(-1); and, 30% (SP1), and 20% (SP2). Therefore, seed's implant activities of 333 MBq (Ho(166)) and 259 GBq (Ir(192)) produced prescribed doses of 58 Gy (SP1; 5d) and 56 Gy (SP1, 5 fractions, 6 min), respectively. Breast Ho(166)-implants of 37-111 MBq are attractive due to the high dose rate near 6-10 mm from seeds, equivalent to Ir(192)-brachytherapy of 259 GBq (3 fractions, 6 min) providing similar dose in standard points at a week; however, with spatial dose distribution better confined. The seed positioning can be adjusted for controlling the breast tumor, in stages I and II, in flat and deep tumors, without any breast volumetric limitation.

Self-expandable CoreValve implantation without contrast media.

PubMed

Bruschi, Giuseppe; Colombo, Paola; De Marco, Federico; Barosi, Alberto; Mauri, Silvia; Klugmann, Silvio

2016-09-01

Transcatheter aortic valve implantation has been designed to treat high-risk surgical patients affected by severe aortic stenosis, many of whom are affected by chronic kidney disease. To perform transcatheter self-expandable valve implantation, multiple contrast injections are required to monitor the procedure, so these patients are at increased risk of acute kidney injury. We described self-expandable transcatheter aortic valve implantation without contrast media in an 80-year-old man affected by severe aortic stenosis and endstage chronic kidney disease. © The Author(s) 2015.

Objective Comparison of Commercially Available Breast Implant Devices.

PubMed

Henderson, Peter W; Nash, David; Laskowski, Marta; Grant, Robert T

2015-10-01

Breast implants are frequently used for both cosmetic breast augmentation and breast reconstruction after mastectomy. Three companies currently offer FDA-approved breast implants (Allergan, Mentor, and Sientra), but their product offerings-including permanent breast implants, breast tissue expanders, sizers, and post-operative warranty-can be difficult to compare because of brand names and company-specific jargon. The ability to have a brand-agnostic understanding of all available options is important for both the surgical trainee as well as the surgeon in clinical practice. After a brief review of the history of breast implant devices, this review utilizes a unique conceptual framework based on variables such as fill material, shape, relative dimensions, and surface coating to facilitate a better understanding of the similarities and differences between the different company's offerings. Specifically, we identify which types of devices are offered by all three companies, those that are offered by only one company, those that have very limited product offerings, and those combinations that are not available at all. Finally, clinical implications are drawn from this framework that can be used by both cosmetic and reconstructive surgeons to counsel patients about all available options. Importantly, this project is entirely independent of any company's funding, support, or input. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

The natural history of Becker expandable breast implants: a single-center 10-year experience.

PubMed

Sindali, Katia; Davis, Marcus; Mughal, Maleeha; Orkar, Kusu S

2013-09-01

Use of Becker expandable breast implants in single-stage breast surgery is a well-established technique; however, replacement with fixed-volume implants is common. The authors sought to analyze the long-term natural history of these implants over a wide range of surgical indications. A retrospective review of 330 consecutive patients who underwent 384 Becker expander breast reconstructions over a 10-year period in a dedicated plastic surgery unit was undertaken. Implant indication, Becker type, volume and site, complications, expander lifespan, and explant reasons were assessed. Two hundred twenty-eight patients (267 implants) and 102 patients (117 implants) underwent implantation for congenital deformities and breast cancer reconstruction, respectively. One hundred eighty-seven (48 percent) were explanted at a median period of 13.0 months (range, 9.0 to 26.0 months), 149 (39 percent) for aesthetic reasons and 38 (10 percent) for complications. Complication rates were higher in breast cancer reconstruction compared with congenital patients (19.6 percent versus 7.9 percent; p = 0.002), driven by an increased rate of wound complications (13.7 percent versus 4.4 percent; p = 0.003). Cancer-related surgery and advancing age were the only predictors of complication risk. The overall Becker expander retention rate was 24.9 percent and 46.8 percent at 150 months in the cancer reconstruction and congenital groups, respectively. Forty-seven percent of Becker implants were retained long term after congenital corrective surgery; only 25 percent were retained after postmastectomy reconstruction. Poor aesthetics was driving the exchange for fixed-volume implants, indicating that after breast cancer reconstruction, Becker expanders were being used as part of a two-stage reconstructive strategy.

Monte Carlo calculated doses to treatment volumes and organs at risk for permanent implant lung brachytherapy

NASA Astrophysics Data System (ADS)

Sutherland, J. G. H.; Furutani, K. M.; Thomson, R. M.

2013-10-01

Iodine-125 (125I) and Caesium-131 (131Cs) brachytherapy have been used with sublobar resection to treat stage I non-small cell lung cancer and other radionuclides, 169Yb and 103Pd, are considered for these treatments. This work investigates the dosimetry of permanent implant lung brachytherapy for a range of source energies and various implant sites in the lung. Monte Carlo calculated doses are calculated in a patient CT-derived computational phantom using the EGsnrc user-code BrachyDose. Calculations are performed for 103Pd, 125I, 131Cs seeds and 50 and 100 keV point sources for 17 implant positions. Doses to treatment volumes, ipsilateral lung, aorta, and heart are determined and compared to those determined using the TG-43 approach. Considerable variation with source energy and differences between model-based and TG-43 doses are found for both treatment volumes and organs. Doses to the heart and aorta generally increase with increasing source energy. TG-43 underestimates the dose to the heart and aorta for all implants except those nearest to these organs where the dose is overestimated. Results suggest that model-based dose calculations are crucial for selecting prescription doses, comparing clinical endpoints, and studying radiobiological effects for permanent implant lung brachytherapy.

Online gamma-camera imaging of 103Pd seeds (OGIPS) for permanent breast seed implantation

NASA Astrophysics Data System (ADS)

Ravi, Ananth; Caldwell, Curtis B.; Keller, Brian M.; Reznik, Alla; Pignol, Jean-Philippe

2007-09-01

Permanent brachytherapy seed implantation is being investigated as a mode of accelerated partial breast irradiation for early stage breast cancer patients. Currently, the seeds are poorly visualized during the procedure making it difficult to perform a real-time correction of the implantation if required. The objective was to determine if a customized gamma-camera can accurately localize the seeds during implantation. Monte Carlo simulations of a CZT based gamma-camera were used to assess whether images of suitable quality could be derived by detecting the 21 keV photons emitted from 74 MBq 103Pd brachytherapy seeds. A hexagonal parallel hole collimator with a hole length of 38 mm, hole diameter of 1.2 mm and 0.2 mm septa, was modeled. The design of the gamma-camera was evaluated on a realistic model of the breast and three layers of the seed distribution (55 seeds) based on a pre-implantation CT treatment plan. The Monte Carlo simulations showed that the gamma-camera was able to localize the seeds with a maximum error of 2.0 mm, using only two views and 20 s of imaging. A gamma-camera can potentially be used as an intra-procedural image guidance system for quality assurance for permanent breast seed implantation.

Determination of prescription dose for Cs-131 permanent implants using the BED formalism including resensitization correction

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

Luo, Wei, E-mail: wei.luo@uky.edu; Molloy, Janelle; Aryal, Prakash

2014-02-15

Purpose: The current widely used biological equivalent dose (BED) formalism for permanent implants is based on the linear-quadratic model that includes cell repair and repopulation but not resensitization (redistribution and reoxygenation). The authors propose a BED formalism that includes all the four biological effects (4Rs), and the authors propose how it can be used to calculate appropriate prescription doses for permanent implants with Cs-131. Methods: A resensitization correction was added to the BED calculation for permanent implants to account for 4Rs. Using the same BED, the prescription doses with Au-198, I-125, and Pd-103 were converted to the isoeffective Cs-131 prescriptionmore » doses. The conversion factor F, ratio of the Cs-131 dose to the equivalent dose with the other reference isotope (F{sub r}: with resensitization, F{sub n}: without resensitization), was thus derived and used for actual prescription. Different values of biological parameters such as α, β, and relative biological effectiveness for different types of tumors were used for the calculation. Results: Prescription doses with I-125, Pd-103, and Au-198 ranging from 10 to 160 Gy were converted into prescription doses with Cs-131. The difference in dose conversion factors with (F{sub r}) and without (F{sub n}) resensitization was significant but varied with different isotopes and different types of tumors. The conversion factors also varied with different doses. For I-125, the average values of F{sub r}/F{sub n} were 0.51/0.46, for fast growing tumors, and 0.88/0.77 for slow growing tumors. For Pd-103, the average values of F{sub r}/F{sub n} were 1.25/1.15 for fast growing tumors, and 1.28/1.22 for slow growing tumors. For Au-198, the average values of F{sub r}/F{sub n} were 1.08/1.25 for fast growing tumors, and 1.00/1.06 for slow growing tumors. Using the biological parameters for the HeLa/C4-I cells, the averaged value of F{sub r} was 1.07/1.11 (rounded to 1.1), and the averaged value of F{sub n} was 1.75/1.18. F{sub r} of 1.1 has been applied to gynecological cancer implants with expected acute reactions and outcomes as expected based on extensive experience with permanent implants. The calculation also gave the average Cs-131 dose of 126 Gy converted from the I-125 dose of 144 Gy for prostate implants. Conclusions: Inclusion of an allowance for resensitization led to significant dose corrections for Cs-131 permanent implants, and should be applied to prescription dose calculation. The adjustment of the Cs-131 prescription doses with resensitization correction for gynecological permanent implants was consistent with clinical experience and observations. However, the Cs-131 prescription doses converted from other implant doses can be further adjusted based on new experimental results, clinical observations, and clinical outcomes.« less

Determination of prescription dose for Cs-131 permanent implants using the BED formalism including resensitization correction

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

Luo, Wei, E-mail: wei.luo@uky.edu; Molloy, Janelle; Aryal, Prakash

Purpose: The current widely used biological equivalent dose (BED) formalism for permanent implants is based on the linear-quadratic model that includes cell repair and repopulation but not resensitization (redistribution and reoxygenation). The authors propose a BED formalism that includes all the four biological effects (4Rs), and the authors propose how it can be used to calculate appropriate prescription doses for permanent implants with Cs-131. Methods: A resensitization correction was added to the BED calculation for permanent implants to account for 4Rs. Using the same BED, the prescription doses with Au-198, I-125, and Pd-103 were converted to the isoeffective Cs-131 prescriptionmore » doses. The conversion factor F, ratio of the Cs-131 dose to the equivalent dose with the other reference isotope (F{sub r}: with resensitization, F{sub n}: without resensitization), was thus derived and used for actual prescription. Different values of biological parameters such as α, β, and relative biological effectiveness for different types of tumors were used for the calculation. Results: Prescription doses with I-125, Pd-103, and Au-198 ranging from 10 to 160 Gy were converted into prescription doses with Cs-131. The difference in dose conversion factors with (F{sub r}) and without (F{sub n}) resensitization was significant but varied with different isotopes and different types of tumors. The conversion factors also varied with different doses. For I-125, the average values of F{sub r}/F{sub n} were 0.51/0.46, for fast growing tumors, and 0.88/0.77 for slow growing tumors. For Pd-103, the average values of F{sub r}/F{sub n} were 1.25/1.15 for fast growing tumors, and 1.28/1.22 for slow growing tumors. For Au-198, the average values of F{sub r}/F{sub n} were 1.08/1.25 for fast growing tumors, and 1.00/1.06 for slow growing tumors. Using the biological parameters for the HeLa/C4-I cells, the averaged value of F{sub r} was 1.07/1.11 (rounded to 1.1), and the averaged value of F{sub n} was 1.75/1.18. F{sub r} of 1.1 has been applied to gynecological cancer implants with expected acute reactions and outcomes as expected based on extensive experience with permanent implants. The calculation also gave the average Cs-131 dose of 126 Gy converted from the I-125 dose of 144 Gy for prostate implants. Conclusions: Inclusion of an allowance for resensitization led to significant dose corrections for Cs-131 permanent implants, and should be applied to prescription dose calculation. The adjustment of the Cs-131 prescription doses with resensitization correction for gynecological permanent implants was consistent with clinical experience and observations. However, the Cs-131 prescription doses converted from other implant doses can be further adjusted based on new experimental results, clinical observations, and clinical outcomes.« less

Pacemaker implantation rate after transcatheter aortic valve implantation with early and new-generation devices: a systematic review.

PubMed

van Rosendael, Philippe J; Delgado, Victoria; Bax, Jeroen J

2018-06-01

The incidence of new-onset conduction abnormalities requiring permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) with new-generation prostheses remains debated. This systematic review analyses the incidence of PPI after TAVI with new-generation devices and evaluates the electrical, anatomical, and procedural factors associated with PPI. In addition, the incidence of PPI after TAVI with early generation prostheses was reviewed for comparison. According to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist, this systematic review screened original articles published between October 2010 and October 2017, reporting on the incidence of PPI after implantation of early and new-generation TAVI prostheses. Of the 1406 original articles identified in the first search for new-generation TAVI devices, 348 articles were examined for full text, and finally, 40 studies (n = 17 139) were included. The incidence of a PPI after the use of a new-generation TAVI prosthesis ranged between 2.3% and 36.1%. For balloon-expandable prostheses, the PPI rate remained low when using an early generation SAPIEN device (ranging between 2.3% and 28.2%), and with the new-generation SAPIEN 3 device, the PPI rate was between 4.0% and 24.0%. For self-expandable prostheses, the PPI rates were higher with the early generation CoreValve device (16.3-37.7%), and despite a reduction in PPI rates with the new Evolut R, the rates remained relatively higher (14.7-26.7%). When dividing the studies according to the highest (>26.0%) and the lowest (<12.1%) quintile of PPI rate, patients within the highest quintile were more frequently women when compared with the lowest quintile group (50.9% vs. 46.3%, P < 0.001). Pre-existent conduction abnormalities (electrical factor), calcification of the left ventricular outflow tract (anatomical factor), and balloon valvuloplasty and depth of implantation (procedural factors) were associated with increased risk of PPI. The rate of PPI after TAVI with new-generation devices is highly variable. Specific recommendations for implantation of each prosthesis, taking into consideration the presence of pre-existent conduction abnormalities and anatomical factors, may be needed to reduce the risk of PPI.

Latissimus Dorsi Myocutaneous Flap for Breast Reconstruction: Bad Rap or Good Flap?

PubMed Central

Perdikis, Galen; Koonce, Stephanie; Collis, George; Eck, Dustin

2011-01-01

Objective: This article serves to review latissimus dorsi myocutaneous flap as an option for breast reconstruction postmastectomy. Since the introduction of the latissimus dorsi myocutaneous flap in the late 1970s, its use has always been as a secondary technique, particularly after the development of the transverse rectus abdominus myocutaneous flap in the 1980s. Methods: A literature review of the history of latissimus dorsi myocutaneous flap utilized for breast reconstruction as well as a review of our institution's experience with latissimus dorsi myocutaneous flap and tissue expander placement was performed. Results: There remains a paucity of published studies investigating latissimus dorsi myocutaneous flap for breast reconstruction. Most studies have small numbers and do not utilize tissue expanders. More recently several small studies have been published that show acceptably low complication rates with aesthetically pleasing outcomes when latissimus dorsi myocutaneous flap is employed with a tissue expander. At our institution, we have employed latissimus dorsi myocutaneous flap with tissue expander placement for both delayed and immediate reconstruction with subsequent replacement with a permanent implant with a capsular contraction rate of 10.5%. Our data and others more recently published demonstrate very acceptable capsular contracture rates and aesthetic outcomes, particularly when an expander is utilized. Conclusion: The latissimus dorsi myocutaneous flap remains an excellent choice for breast reconstruction with a low risk of complications. PMID:22031843

Weight Measurement and Volumetric Displacement of Breast Implants and Tissue Expanders: Why Port and Shell Volumes Matter in Breast Reconstruction, Augmentation, and Revision.

PubMed

Wenzel, Chad G; Wacholtz, William F; Janssen, David A; Bengtson, Bradley P

2015-10-01

There are significant differences in weight and volumetric characteristics between silicone and saline breast implants of which most plastic surgeons are unaware. Phase I of this study was a weight measurement focused on recording differences in the weight of saline volumes instilled versus recorded weights of saline implants and expanders. Phase II compared displaced volume differences of tissue expanders with instilled volumes. As a result of this study, surgeons should now be able to precisely calculate the volume created for breast pocket development, allowing for accurate matching of expander and final breast implant. Copyright © 2015 Elsevier Inc. All rights reserved.

Management and outcome of topical beta-blockerinduced atrioventricular block

PubMed Central

Özcan, Kazım Serhan; Güngör, Barış; Tekkeşin, Ahmet İlker; Altay, Servet; Ekmekçi, Ahmet; Toprak, Ercan; Yıldırım, Ersin; Çalık, Nazmi; Alper, Ahmet Taha; Gürkan, Kadir; Erdinler, İzzet; Osmonov, Damirbek

2015-01-01

Summary Background Topical beta-blockers have a well-established role in the treatment of glaucoma. We aimed to investigate the outcome of patients who developed symptomatic atrioventricular (AV) block induced by topical beta-blockers. Methods All patients admitted or discharged from our institution, the Siyami Ersek Training and Research Hospital, between January 2009 and January 2013 with a diagnosis of AV block were included in the study. Subjects using ophthalmic beta-blockers were recruited and followed for permanent pacemaker requirement during hospitalisation and for three months after discontinuation of the drug. A permanent pacemaker was implanted in patients in whom AV block persisted beyond 72 hours or recurred during the follow-up period. Results A total of 1 122 patients were hospitalised with a diagnosis of AV block and a permanent pacemaker was implanted in 946 cases (84.3%) during the study period. Thirteen patients using ophthalmic beta-blockers for the treatment of glaucoma and no other rate-limiting drugs were included in the study. On electrocardiography, eight patients had complete AV block and five had high-degree AV block. The ophthalmic beta-blockers used were timolol in seven patients (55%), betaxolol in four (30%), and cartelol in two cases (15%). The mean duration of ophthalmic beta-blocker treatment was 30.1 ± 15.9 months. After drug discontinuation, in 10 patients the block persisted and a permanent pacemaker was implanted. During follow up, one more patient required pacemaker implantation. Therefore in total, pacemakers were implanted in 11 out of 13 patients (84.6%). The pacemaker implantation rate did not differ according to the type of topical beta-blocker used (p = 0.37). The presence of infra-nodal block on electrocardiography was associated with higher rates of pacemaker implantation. Conclusion Our results indicate that topical beta-blockers for the treatment of glaucoma may cause severe conduction abnormalities and when AV block occurs, pacemaker implantation is required in a high percentage of the patients. PMID:26659434

Assessment of wrought ASTM F1058 cobalt alloy properties for permanent surgical implants.

PubMed

Clerc, C O; Jedwab, M R; Mayer, D W; Thompson, P J; Stinson, J S

1997-01-01

The behavior of the ASTM F1058 wrought cobalt-chromium-nickel-molybdenum-iron alloy (commonly referred to as Elgiloy or Phynox) is evaluated in terms of mechanical properties, magnetic resonance imaging, corrosion resistance, and biocompatibility. The data found in the literature, the experimental corrosion and biocompatibility results presented in this article, and its long track record as an implant material demonstrate that the cobalt superalloy is an appropriate material for permanent surgical implants that require high yield strength and fatigue resistance combined with high elastic modulus, and that it can be safely imaged with magnetic resonance.

Serving Deaf Students Who Have Cochlear Implants. PEPNet Tipsheet

ERIC Educational Resources Information Center

Searls, J. Matt, Comp.

2010-01-01

Cochlear implants (CIs) are complex electronic devices surgically implanted under the skin behind the ear. These devices utilize electrodes placed in the inner ear (the cochlea) to stimulate the auditory nerve of individuals with significant permanent hearing loss. Cochlear implants may not be suitable for everyone. They are designed to provide…

Permanent cardiac pacing in patients with end-stage renal disease undergoing dialysis.

PubMed

Wang, I-Kuan; Lin, Kuo-Hung; Lin, Shih-Yi; Lin, Cheng-Li; Chang, Chiz-Tzung; Yen, Tzung-Hai; Sung, Fung-Chang

2016-12-01

Studies investigating the risk of cardiac dysrhythmia warranting permanent pacemaker therapy for end-stage renal disease (ESRD) patients are limited. This study investigated the incidence rate of permanent cardiac pacing in dialysis patients. Using the Taiwan National Health Insurance Database, we identified 28 471 newly diagnosed ESRD patients in 2000-2010 [9700 on peritoneal dialysis (PD) and 18 771 on hemodialysis (HD)] and 113 769 randomly selected controls without kidney disease, frequency-matched by sex, age and diagnosis date. We also established propensity score-matched HD and PD cohorts with 9700 patients each. Incidence rates and hazard ratios (HRs) of implantation were evaluated by the end of 2011. Complications were also evaluated among patients with implantation. The incidence rates of permanent pacemaker implantation were 5.93- and 3.50-fold greater in HD and PD patients than in controls (1.44 and 0.85 versus 0.24 per 1000 person-years, respectively). The adjusted HRs (aHRs) of implantation were 3.26 [95% confidence interval (CI) = 2.41-4.42] and 2.36 (95% CI = 1.56-3.58) for HD and PD patients, respectively, compared with controls. The pacemaker implantation rate was 0.33 per 1000 person-years greater in the propensity score-matched HD cohort than in the PD cohort, with an aHR of 1.30 (95% CI = 0.82-2.05) for the HD cohort compared with the PD cohort. Dialysis patients are at an increased risk of dysrhythmia requiring pacemaker implantation compared with the general population. The risks are not significantly different between HD and PD patients. © The Author 2016. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

Conduction Abnormalities and Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement Using the Repositionable LOTUS Device: The United Kingdom Experience.

PubMed

Rampat, Rajiv; Khawaja, M Zeeshan; Hilling-Smith, Roland; Byrne, Jonathan; MacCarthy, Philip; Blackman, Daniel J; Krishnamurthy, Arvindra; Gunarathne, Ashan; Kovac, Jan; Banning, Adrian; Kharbanda, Raj; Firoozi, Sami; Brecker, Stephen; Redwood, Simon; Bapat, Vinayak; Mullen, Michael; Aggarwal, Suneil; Manoharan, Ganesh; Spence, Mark S; Khogali, Saib; Dooley, Maureen; Cockburn, James; de Belder, Adam; Trivedi, Uday; Hildick-Smith, David

2017-06-26

The authors report the incidence of pacemaker implantation up to hospital discharge and the factors influencing pacing rate following implantation of the LOTUS bioprosthesis (Boston Scientific, Natick, Massachusetts) in the United Kingdom. Transcatheter aortic valve replacement (TAVR) is associated with a significant need for permanent pacemaker implantation. Pacing rates vary according to the device used. The REPRISE II (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System) trial reported a pacing rate of 29% at 30 days after implantation of the LOTUS device. Data were collected retrospectively on 228 patients who had the LOTUS device implanted between March 2013 and February 2015 across 10 centers in the United Kingdom. Twenty-seven patients (12%) had pacemakers implanted pre-procedure and were excluded from the analysis. Patients were aged 81.2 ± 7.7 years; 50.7% were male. The mean pre-procedural QRS duration was 101.7 ± 20.4 ms. More than one-half of the cohort (n = 111, 55%) developed new left bundle branch block (LBBB) following the procedure. Permanent pacemakers were implanted in 64 patients (32%) with a median time to insertion of 3.0 ± 3.4 days. Chief indications for pacing were atrioventricular (AV) block (n = 46, 72%), or LBBB with 1st degree AV block (n = 11, 17%). Amongst those who received a pacemaker following TAVR the pre-procedural electrocardiogram findings included: No conduction disturbance (n = 41, 64%); 1st degree AV block (n = 10, 16%); right bundle branch block (n = 6, 9%) and LBBB (n = 5, 8%). LBBB (but not permanent pacemaker) occurred more frequently in patients who had balloon aortic valvuloplasty before TAVR (odds ratio [OR]: 1.25; p = 0.03). Pre-procedural conduction abnormality (composite of 1st degree AV block, hemiblock, right bundle branch block, LBBB) was independently associated with the need for permanent pacemaker (OR: 2.54; p = 0.048). The absence of aortic valve calcification was also associated with a higher pacing rate (OR: 0.55; p = 0.031). Multivariate regression analysis did not show an independent association between depth of implant, valve oversizing, balloon post-dilatation, and the need for pacing post-procedure. Following implantation of the repositionable LOTUS valve, 55% of patients developed LBBB and 32% of patients required a pacemaker during their index hospital admission. Patients with pre-procedural conduction disturbance and non-calcified aortic valves were more likely to need pacing. No other anatomic features were identified with increased pacing requirement with the LOTUS device. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

Effects of Appropriate Prolonged Sacral Neuromodulation Testing in Improving Implantation Rate of a Permanent Implantable Pulse Generator in Patients with Refractory Lower Urinary Tract Dysfunctions in Mainland China.

PubMed

Zhang, Peng; Zhang, Jian-Zhong; Wu, Li-Yang; Zhang, Xiao-Dong

2017-02-20

Sacral neuromodulation (SNM) has become an effective method for treating lower urinary tract voiding dysfunction during the past 20 years. Because of the expensive cost, the number of implantable pulse generator (IPG) implantations per year in China is far lower than that in Western developed countries since 2012. This study was to summarize the effects of the appropriate prolonged SNM testing time in improving the implantation rate of a permanent IPG in patients with refractory lower urinary tract symptoms (LUTS) in mainland China. From January 2013 to June 2016, 51 patients with refractory LUTS received SNM therapy. In this study, we compared the conversion rate 2 weeks after the Stage I test and final actual conversion rate. We also observed the complications (such as pain, infection, and electrode displacement) and effectiveness. We tried to improve an appropriate prolonged test time which was favorable for improving the SNM conversion rate while ensuring safety and effectiveness. Among 51 patients receiving SNM therapy, 19 patients (mean age 45.0 ± 16.9 years) had poor Stage I test results, and on an average, the electrode was removed 27.4 ± 9.6 days after the surgery. In one patient, the electrode was removed within 2 weeks; when the remaining 18 patients were questioned 2 weeks after testing, none of the patients wanted to terminate the test, and all the 18 patients desired to prolong the testing time to further observe the treatment effect. The remaining 32 patients (mean age 46.7 ± 15.3 years) received Stage II permanent implantation at 19.6 ± 10.4 days after the surgery. The overall Stage I-II conversion was 62.7% (32/51) in this study. Within 2 weeks after the surgery, only eight patients received Stage II permanent implantation, and the conversion rate was only 15.7% (8/51), which was much lower than the overall conversion rate of 62.7%. Nearly 84.4% (27/32) of the patients received Stage II implantation within 4 weeks. None of the patients had incision infections. In one patient, the entire system was removed 1 month after Stage II implantation due to pain in the implantation site. Appropriate extension of the Stage I testing time of an SNM-barbed electrode could significantly improve the Stage II permanent implantation rate in Chinese refractory LUTS patients; there were no wound infections, and the postoperative complication rate was low. This study recommended that Stage I period of SNM therapy should be 4 weeks according to safety and successful conversion rate.

Prospective study of tricuspid valve regurgitation associated with permanent leads in patients undergoing cardiac rhythm device implantation: Background, rationale, and design

PubMed Central

Dokainish, Hisham; Elbarasi, Esam; Masiero, Simona; Van de Heyning, Caroline; Brambatti, Michela; Ghazal, Sami; AL-Maashani, Said; Capucci, Alessandro; Buikema, Lisanne; Leong, Darryl; Shivalkar, Bharati; Saenen, Johan; Miljoen, Hielko; Morillo, Carlos; Divarakarmenon, Syam; Amit, Guy; Ribas, Sebastian; Brautigam, Aaron; Baiocco, Erika; Maolo, Alessandro; Romandini, Andrea; Maffei, Simone; Connolly, Stuart; Healey, Jeff

2015-01-01

Given the increasing numbers of cardiac device implantations worldwide, it is important to determine whether permanent endocardial leads across the tricuspid valve can promote tricuspid regurgitation (TR). Virtually all current data is retrospective, and indicates a signal of TR being increased after permanent lead implantation. However, the precise incidence of moderate or greater TR post-procedure, the exact mechanisms (mechanical, traumatic, functional), and the hemodynamic burden and clinical effects of this putative increase in TR, remain uncertain. We have therefore designed a multicenter, international, prospective study of 300 consecutive patients (recruitment completed, baseline data presented) who will undergo echocardiography and clinical assessment prior to, and at 1-year post device insertion. This prospective study will help determine whether cardiac device-associated TR is real, what are its potential mechanisms, and whether it has an important clinical impact on cardiac device patients. PMID:26779517

Late Outcome and Predictors of Adverse Events Related to the Implantation of a Permanent Pacemaker in Patients with Isolated Congenital Atrioventricular Block.

PubMed

de Oliveira, Grasiele Bess; de Oliveira, Fábio Silveira; Osório, Ana Paula Susin; Medeiros, Alexandre Kreling; Sant'anna, João Ricardo Michielin; Leiria, Tiago Luiz Luz

2016-10-01

Isolated congenital atrioventricular block (ICAVB) is a rare, and pacemaker implantation is the only effective treatment. We sought to identify the predictive factors of adverse events related to pacemaker implantation in ICAVB. This is a cohort study of patients diagnosed with ICAVB who underwent pacemaker implantation from 1980 to 2014 in a single center. During the studied period, a total of 647 patients underwent implantation of their first permanent cardiac pacemaker before 30 years of age. Of these, only 62 (9.5 %) were diagnosed with ICAVB. This condition was diagnosed in utero in 15 (24.2 %) cases, 5 (8.1 %) in the neonatal period, 32 (51.6 %) during childhood, and 10 (16.1 %) during adolescence and young adulthood. The presence of autoantibodies (anti-Ro/SSA) was observed in 41 % of mothers who underwent serological evaluation. Age at the time of the initial pacemaker implant was 9.8 ± 9 years. During a mean follow-up time of 15 years, 1 (1.7 %) death occurred due to infectious endocarditis. Complications related to pacemaker implant were reported in 24 patients (38.7 %). The number of complications was significantly higher in the group with an epimyocardial implantation site (HR 6; CI 2.45-14.95). Ventricular dysfunction occurred in 6 (11.7 %) patients; however, we were not able to identify any predictors of it. Our results showed a low mortality rate after permanent therapy. However, these patients exhibited high morbidity related to the pacemaker system, and the epimyocardial implant site was an independent predictor of complications. Predictors of left ventricular dysfunction were not found in the present study.

Permanent Leadless Cardiac Pacemaker Therapy: A Comprehensive Review.

PubMed

Tjong, Fleur V Y; Reddy, Vivek Y

2017-04-11

A new technology, leadless pacemaker therapy, was recently introduced clinically to address lead- and pocket-related complications in conventional transvenous pacemaker therapy. These leadless devices are self-contained right ventricular single-chamber pacemakers implanted by using a femoral percutaneous approach. In this review of available clinical data on leadless pacemakers, early results with leadless devices are compared with historical results with conventional single-chamber pacing. Both presently manufactured leadless pacemakers show similar complications, which are mostly related to the implant procedure: cardiac perforation, device dislocation, and femoral vascular access site complications. In comparison with conventional transvenous single-chamber pacemakers, slightly higher short-term complication rates have been observed: 4.8% for leadless pacemakers versus 4.1% for conventional pacemakers. The complication rate of the leadless pacemakers is influenced by the implanter learning curve for this new procedure. No long-term outcome data are yet available for the leadless pacemakers. Larger leadless pacing trials, with long-term follow-up and direct randomized comparison with conventional pacing systems, will be required to define the proper clinical role of these leadless systems. Although current leadless pacemakers are limited to right ventricular pacing, future advanced, communicating, multicomponent systems are expected to expand the potential benefits of leadless therapy to a larger patient population. © 2017 American Heart Association, Inc.

Early Outcomes for Valve-in-valve Transcatheter Aortic Valve Replacement in Degenerative Freestyle Bioprostheses.

PubMed

Sang, Stephane Leung Wai; Beute, Tyler; Heiser, John; Berkompas, Duane; Fanning, Justin; Merhi, William

2017-11-20

Transcatheter aortic valve replacement (TAVR) is used increasingly to treat bioprosthetic valve failure. A paucity of data exists regarding valve-in-valve (ViV) TAVR in degenerated Freestyle stentless bioprostheses (FSBs). This study sought to evaluate the feasibility and short-term outcomes of ViV TAVR in previously placed FSB. From October 2014 to September 2016, 22 patients at a single institution underwent ViV TAVR with a self-expanding transcatheter valve for a failing FSB. Patient baseline characteristics and clinical outcomes data were collected retrospectively and entered into a dedicated database. The mean patient age was 74 ± 9years, and the mean Society of Thoracic Surgeons' Risk score was 9.0 ± 7.4%. Ten patients presented with acute heart failure requiring urgent intervention. The most common mode of failure of the FSB was regurgitation caused by a flail or malcoapting leaflet. Seventeen (77%) patients had a modified subcoronary implantation, 3 (14%) had a full root replacement, and 2 (9%) had a root inclusion. Device success using a self-expanding transcatheter valve was 95%, all via transfemoral approach. The mean implant depth was 7 ± 3 mm. Thirty-day survival was 100%. No patient had more than mild paravalvular regurgitation at 30days, and the permanent pacemaker rate was 9%. The mean hospital stay after intervention was 5 ± 2days. ViV TAVR using a self-expanding transcatheter valve is safe, feasible, and can be used successfully to treat a failed FSB. Procedural challenges suggest referral to valve centers of excellence. Copyright © 2017 Elsevier Inc. All rights reserved.

Aortic annulus eccentricity before and after transcatheter aortic valve implantation: Comparison of balloon-expandable and self-expanding prostheses.

PubMed

Schuhbaeck, Annika; Weingartner, Christina; Arnold, Martin; Schmid, Jasmin; Pflederer, Tobias; Marwan, Mohamed; Rixe, Johannes; Nef, Holger; Schneider, Christian; Lell, Michael; Uder, Michael; Ensminger, Stephan; Feyrer, Richard; Weyand, Michael; Achenbach, Stephan

2015-07-01

The geometry of the aortic annulus and implanted transcatheter aortic valve prosthesis might influence valve function. We investigated the influence of valve type and aortic valve calcification on post-implant geometry of catheter-based aortic valve prostheses. Eighty consecutive patients with severe aortic valve stenosis (mean age 82 ± 6 years) underwent computed tomography before and after TAVI. Aortic annulus diameters were determined. Influence of prosthesis type and degree of aortic valve calcification on post-implant eccentricity were analysed. Aortic annulus eccentricity was reduced in patients after TAVI (0.21 ± 0.06 vs. 0.08 ± 0.06, p<0.0001). Post-TAVI eccentricity was significantly lower in 65 patients following implantation of a balloon-expandable prosthesis as compared to 15 patients who received a self-expanding prosthesis (0.06 ± 0.05 vs. 0.15 ± 0.07, p<0.0001), even though the extent of aortic valve calcification was not different. After TAVI, patients with a higher calcium amount retained a significantly higher eccentricity compared to patients with lower amounts of calcium. Patients undergoing TAVI with a balloon-expandable prosthesis show a more circular shape of the implanted prosthesis as compared to patients with a self-expanding prosthesis. Eccentricity of the deployed prosthesis is affected by the extent of aortic valve calcification. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Redo surgery after permanent pacemaker implantation: performance indicator of surgical techniques and pacing technology.

PubMed

Bharat, Vijaya

2004-01-01

The incidence of permanent pacemaker-related complications is reducing due to advancement of technology and increasing operator experience. There are only few series from India reporting the annual complication rates from a single center over the years. This is a series of 782 pacemakers implanted over 20 years in a secondary healthcare set-up. Eighty-two patients underwent redo surgery, either for a procedure-related complication (n=34) or for replacement of a malfunctioning/end-of-life pacemaker (n=48). Through critical analysis and corrective measures, all the procedural complications were reduced to less than 4% of the annual implantations. The introduction of a pacemaker follow-up clinic contributed to reducing the rate of elective replacement for battery depletion from 19.17% of the implanted VVI pacemakers to 0.63%. Despite being a low-volume center, with less than 100 pacemakers implanted annually, the performance of our pacing practice has shown continuous improvement.

Pacemaker therapy in low-birth-weight infants.

PubMed

Fuchigami, Tai; Nishioka, Masahiko; Akashige, Toru; Shimabukuro, Atsuya; Nagata, Nobuhiro

2018-02-01

Infants born with complete atrioventricular block (CAVB) and fetal bradycardia are frequently born with low birth weight. Three low-birth-weight CAVB infants underwent temporary pacemaker implantation, followed by permanent single-chamber pacemaker implantation at median body weights of 1.7 and 3.2 kg, respectively. All infants caught up with their growth curves and had >3 years of estimated residual battery life. This two-stage strategy was successful in facilitating permanent pacemaker implantation in low-birth-weight babies. Placement of single-chamber pacemaker on the apex of the left ventricle appears to be associated with longer battery lifespan. © 2018 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.

SU-F-J-167: Use of MR for Permanent Prostate Implant Preplanning

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

Narayana, V; McLaughlin, P; University of Michigan, Ann Arbor, MI

Purpose: To study the feasibility using MR imaging to improve target definition on ultrasound during permanent prostate implants and aid in source strength determination for treatment planning in the OR. Methods: Patients who receive permanent prostate implants undergo MR and CT imaging prior to the implant procedure to determine the volume of the prostate, bony restriction to the procedure, bladder extension, external sphincter length and neurovascular bundle. The volume of the prostate is generally used to order seeds for the procedure. In 10 patients, the MR was used as the preplanning study with the PTV defined as a 2 mmmore » expansion of the MR prostate in all directions except the posterior. Various dose volume parameters for the MR prostate and the PTV were compared to the actual preplan developed and executed in the OR. In addition, there parameters were compared to the post implant dosimetry performed 3 weeks after the implant procedure. Results: The results show that the number of seeds used using MR and US (ultrasound) planning was generally with 2 seeds and the maximum difference was 7 seeds. There is no significant difference between any of the dose index parameters of V100, V150, V200, D99 and D90 parameters between MR planning, US planning and postimplant evaluation There was a significant difference between planned D99 (avg of 105%) and achieved D99 (avg 91%). Conclusion: MR imaging is an invaluable tool to improve target definition for permanent prostate implants. Use of MR images for preplanning improves the confidence with which source can be ordered for the procedure that is OR planned. Ordering a maximum of 10 seeds more than planned would be sufficient to deliver a plan in the OR using US. Moving ahead to non-rigid registration between MR ad US images could further increase the confidence level of MR planning.« less

Bilateral implant reconstruction does not affect the quality of postmastectomy radiation therapy

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

Ho, Alice Y., E-mail: hoa1234@mskcc.org; Patel, Nisha; Ohri, Nisha

To determine if the presence of bilateral implants, in addition to other anatomic and treatment-related variables, affects coverage of the target volume and dose to the heart and lung in patients receiving postmastectomy radiation therapy (PMRT). A total of 197 consecutive women with breast cancer underwent mastectomy and immediate tissue expander (TE) placement, with or without exchange for a permanent implant (PI) before radiation therapy at our center. PMRT was delivered with 2 tangential beams + supraclavicular lymph node field (50 Gy). Patients were grouped by implant number: 51% unilateral (100) and 49% bilateral (97). The planning target volume (PTV)more » (defined as implant + chest wall + nodes), heart, and ipsilateral lung were contoured and the following parameters were abstracted from dose-volume histogram (DVH) data: PTV D{sub 95%} > 98%, Lung V{sub 20}Gy > 30%, and Heart V{sub 25}Gy > 5%. Univariate (UVA) and multivariate analyses (MVA) were performed to determine the association of variables with these parameters. The 2 groups were well balanced for implant type and volume, internal mammary node (IMN) treatment, and laterality. In the entire cohort, 90% had PTV D{sub 95%} > 98%, indicating excellent coverage of the chest wall. Of the patients, 27% had high lung doses (V{sub 20}Gy > 30%) and 16% had high heart doses (V{sub 25}Gy > 5%). No significant factors were associated with suboptimal PTV coverage. On MVA, IMN treatment was found to be highly associated with high lung and heart doses (both p < 0.0001), but implant number was not (p = 0.54). In patients with bilateral implants, IMN treatment was the only predictor of dose to the contralateral implant (p = 0.001). In conclusion, bilateral implants do not compromise coverage of the target volume or increase lung and heart dose in patients receiving PMRT. The most important predictor of high lung and heart doses in patients with implant-based reconstruction, whether unilateral or bilateral, is treatment of the IMNs. Refinement of radiation techniques in reconstructed patients who require comprehensive nodal irradiation is warranted.« less

Is expansion of artificial dermis a reliable reconstructive option?

PubMed Central

Tsoutsos, D.; Zapantioti, P.; Kakagia, D.; Salmas, M.; Marra, A.; Kyriopoulos, E.

2011-01-01

Summary Reconstruction of full-thickness defects with the use of artificial dermis has been well established in the recent literature. The capacity of artificial dermis to expand over a period of years, months, or even days is described. Three such cases are reported. Two female patients, aged 21 and 30 years, with post-burn contractures of the chest with right breast hypoplasia and abdominal wall post-burn contractures respectively, and a 14-year-old male with a giant congenital naevus on the forearm, are presented. After excision of the contractures and the congenital naevus, the patients underwent staged reconstruction with the use of artificial dermal template and split-thickness skin autografts at monthly intervals. The 21-yr-old female also had a tissue expander placed submuscularly which six months later was replaced by a permanent silicone implant. Gradual expansion of artificial dermis within three weeks resulted in reconstruction of a breast of natural shape, size, and volume. In the second patient the artificial dermis was expanded over a period of months, until full-term pregnancy, while the third patient took years to achieve expansion naturally as he grew up. In conclusion, artificial dermis can be expanded over various periods of time (days to years), providing a reliable and safe alternative reconstructive method, particularly in areas where expansion is an absolute necessity for a good functional and aesthetic result. PMID:22639566

Poster — Thur Eve — 41: Considerations for Patients with Permanently Implant Radioactive Sources Requiring Unrelated Surgery

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

Basran, P. S; Beckham, WA; Baxter, P

Permanent implant of sealed radioactive sources is an effective technique for treating cancer. Typically, the radioactive sources are implanted in and near the disease, depositing dose locally over several months. There may be instances where these patients must undergo unrelated surgical procedures when the radioactive material remains active enough to pose risks. This work explores these risks, discusses strategies to mitigate those risks, and describes a case study for a permanent I-125 prostate brachytherapy implant patient who developed colo-rectal cancer and required surgery 6 months after brachytherapy. The first consideration is identifying the risk from unwarranted radiation to the patientmore » and staff before, during, and after the surgical procedure. The second is identifying the risk the surgical procedure may have on the efficacy of the brachytherapy implant. Finally, there are considerations for controlling for radioactive substances from a regulatory perspective. After these risks are defined, strategies to mitigate those risks are considered. These strategies may include applying the concepts of ALARA, the use of protective equipment and developing a best practice strategy with the operating room team. We summarize this experience with some guidelines: If the surgical procedure is near (ex: 5 cm) of the implant; and, the surgical intervention may dislodge radioisotopes enough to compromise treatment or introduces radiation safety risks; and, the radioisotope has not sufficiently decayed to background levels; and, the surgery cannot be postponed, then a detailed analysis of risk is advised.« less

[TRENDS OF PERMANENT PACEMAKER IMPLANTATION IN A SINGLE CENTER OVER A 20-YEAR PERIOD].

PubMed

Antonelli, Dante; Ilan, Limor Bushar; Freedberg, Nahum A; Feldman, Alexander; Turgeman, Yoav

2015-05-01

To review the changes in permanent pacemaker implantation indications, pacing modes and patients' demographics over a 20-year period. We retrospectively retrieved data on patients who underwent first implantation of the pacemaker between 1-1-1991 and 31-12-2010. One thousand and nine (1,009) patients underwent a first pacemaker implantation during that period; 535 were men (53%), their mean age was 74.6±19.5 years; the highest rate of implanted pacemaker was in patients ranging in age from 70-79 years, however there was an increasing number of patients aged over 80 years. The median survival time after initial pacemaker implantation was 8 years. Syncope was the most common symptom (62.5%) and atrioventricular block was the most common electrocardiographic indication (56.4%) leading to pacemaker implantation. There was increased utilization of dual chamber and rate responsive pacemakers over the years. There was no difference regarding mode selection between genders. Pacemaker implantation rates have increased over a 20-year period. Dual chamber replaced most of the single ventricular chamber pacemaker and rate responsive pacemakers became the norm. The data of a small volume center are similar to those reported in pacemaker surveys of high volume pacemaker implantation centers. They confirm adherence to the published guidelines for pacing.

Improving neuromodulation technique for refractory voiding dysfunctions: two-stage implant.

PubMed

Janknegt, R A; Weil, E H; Eerdmans, P H

1997-03-01

Neuromodulation is a new technique that uses electrical stimulation of the sacral nerves for patients with refractory urinary urge/frequency or urge-incontinence, and some forms of urinary retention. The limiting factor for receiving an implant is often a failure of the percutaneous nerve evaluation (PNE) test. Present publications mention only about a 50% success score for PNE of all patients, although the micturition diaries and urodynamic parameters are similar. We wanted to investigate whether PNE results improved by using a permanent electrode as a PNE test. This would show that improvement of the PNE technique is feasible. In 10 patients where the original PNE had failed to improve the micturition diary parameters more than 50%, a permanent electrode was implanted by operation. It was connected to an external stimulator. In those cases where the patients improved according to their micturition diary by more than 50% during a period of 4 days, the external stimulator was replaced by a permanent subcutaneous neurostimulator. Eight of the 10 patients had a good to very good result (60% to 90% improvement) during the testing period and received their implant 5 to 14 days after the first stage. The good results of the two-stage implant technique we used indicate that the development of better PNE electrodes may lead to an improvement of the testing technique and better selection between nonresponders and technical failures.

Novel expandable short dental implants in situations with reduced vertical bone height-technical note and first results.

PubMed

Reich, Waldemar; Schweyen, Ramona; Heinzelmann, Christian; Hey, Jeremias; Al-Nawas, Bilal; Eckert, Alexander Walter

2017-10-30

Short implants often have the disadvantage of reduced primary stability. The present study was conducted to evaluate the feasibility and safety of a new expandable short dental implant system intended to increase primary stability. As a "proof of concept", a prospective clinical cohort study was designed to investigate intraoperative handling, primary and secondary implant stability (resonance frequency analysis), crestal bone changes, implant survival and implant success, of an innovative short expandable screw implant. From 2014 until 2015, 9 patients (7-9-mm vertical bone height) with 30 implants (length 5-7 mm, diameter 3.75-4.1 mm) were recruited consecutively. All 30 implants in the 9 patients (age 44 to 80 years) could be inserted and expanded without intraoperative problems. Over the 3-year follow-up period, the implant success rate was 28/30 (93.3%). The mean implant stability quotients (ISQ) were as follows: primary stability, 69.7 ± 10.3 ISQ units, and secondary stability, 69.8 ± 10.2 ISQ units (p = 0.780), both without significant differences between the maxilla and mandible (p ≥ 0.780). The mean crestal bone changes after loading were (each measured from the baseline) as follows: in the first year, 1.0 ± 0.9 mm in the maxilla and 0.7 ± 0.4 mm in the mandible, and in the second year, 1.3 ± 0.8 mm and 1.0 ± 0.7 mm, respectively. Compared to other prospective studies, in this indication, the success rate is acceptable. Implant stability shows high initial and secondary stability values. The system might present an extension of functional rehabilitation to the group of elderly patients with limited vertical bone height. Further long-term investigations should directly compare this compressive implant with standard short implants.

A comparative study of zirconium and titanium implants in rat: osseointegration and bone material quality.

PubMed

Hoerth, Rebecca M; Katunar, María R; Gomez Sanchez, Andrea; Orellano, Juan C; Ceré, Silvia M; Wagermaier, Wolfgang; Ballarre, Josefina

2014-02-01

Permanent metal implants are widely used in human medical treatments and orthopedics, for example as hip joint replacements. They are commonly made of titanium alloys and beyond the optimization of this established material, it is also essential to explore alternative implant materials in view of improved osseointegration. The aim of our study was to characterize the implant performance of zirconium in comparison to titanium implants. Zirconium implants have been characterized in a previous study concerning material properties and surface characteristics in vitro, such as oxide layer thickness and surface roughness. In the present study, we compare bone material quality around zirconium and titanium implants in terms of osseointegration and therefore characterized bone material properties in a rat model using a multi-method approach. We used light and electron microscopy, micro Raman spectroscopy, micro X-ray fluorescence and X-ray scattering techniques to investigate the osseointegration in terms of compositional and structural properties of the newly formed bone. Regarding the mineralization level, the mineral composition, and the alignment and order of the mineral particles, our results show that the maturity of the newly formed bone after 8 weeks of implantation is already very high. In conclusion, the bone material quality obtained for zirconium implants is at least as good as for titanium. It seems that the zirconium implants can be a good candidate for using as permanent metal prosthesis for orthopedic treatments.

Quantitative grading of a human blastocyst: optimal inner cell mass size and shape.

PubMed

Richter, K S; Harris, D C; Daneshmand, S T; Shapiro, B S

2001-12-01

To investigate the predictive value of quantitative measurements of blastocyst morphology on subsequent implantation rates after transfer. Prospective observational study. Private assisted reproductive technology center. One hundred seventy-four IVF patients receiving transfers of expanded blastocyst-stage embryos on day 5 (n = 112) or day 6 (n = 62) after oocyte retrieval. None. Blastocyst diameter, number of trophectoderm cells, inner cell mass (ICM) size, ICM shape, and implantation and pregnancy rates. Blastocyst diameter and trophectoderm cell numbers were unrelated to implantation rates. Day 5 expanded blastocysts with ICMs of >4,500 microm(2) implanted at a higher rate than did those with smaller ICMs (55% vs. 31%). Day 5 expanded blastocysts with slightly oval ICMs implanted at a higher rate (58%) compared with those with either rounder ICMs (7%) or more elongated ICMs (33%). Implantation rates were highest (71%) for embryos with both optimal ICM size and shape. Pregnancy rates were higher for day 5 transfers of optimally shaped ICMs compared with day 5 transfers of optimally sized ICMs. Quantitative measurements of the inner cell mass are highly indicative of blastocyst implantation potential. Blastocysts with relatively large and/or slightly oval ICMs are more likely to implant than other blastocysts.

Definition of medical event is to be based on the total source strength for evaluation of permanent prostate brachytherapy: A report from the American Society for Radiation Oncology.

PubMed

Nag, Subir; Demanes, D Jeffrey; Hagan, Michael; Rivard, Mark J; Thomadsen, Bruce R; Welsh, James S; Williamson, Jeffrey F

2011-10-01

The Nuclear Regulatory Commission deems it to be a medical event (ME) if the total dose delivered differs from the prescribed dose by 20% or more. A dose-based definition of ME is not appropriate for permanent prostate brachytherapy as it generates too many spurious MEs and thereby creates unnecessary apprehension in patients, and ties up regulatory bodies and the licensees in unnecessary and burdensome investigations. A more suitable definition of ME is required for permanent prostate brachytherapy. The American Society for Radiation Oncology (ASTRO) formed a working group of experienced clinicians to review the literature, assess the validity of current regulations, and make specific recommendations about the definition of an ME in permanent prostate brachytherapy. The working group found that the current definition of ME in §35.3045 as "the total dose delivered differs from the prescribed dose by 20 percent or more" was not suitable for permanent prostate brachytherapy since the prostate volume (and hence the resultant calculated prostate dose) is dependent on the timing of the imaging, the imaging modality used, the observer variability in prostate contouring, the planning margins used, inadequacies of brachytherapy treatment planning systems to calculate tissue doses, and seed migration within and outside the prostate. If a dose-based definition for permanent implants is applied strictly, many properly executed implants would be improperly classified as an ME leading to a detrimental effect on brachytherapy. The working group found that a source strength-based criterion, of >20% of source strength prescribed in the post-procedure written directive being implanted outside the planning target volume is more appropriate for defining ME in permanent prostate brachytherapy. ASTRO recommends that the definition of ME for permanent prostate brachytherapy should not be dose based but should be based upon the source strength (air-kerma strength) administered.

An automated, fast and accurate registration method to link stranded seeds in permanent prostate implants

NASA Astrophysics Data System (ADS)

Westendorp, Hendrik; Nuver, Tonnis T.; Moerland, Marinus A.; Minken, André W.

2015-10-01

The geometry of a permanent prostate implant varies over time. Seeds can migrate and edema of the prostate affects the position of seeds. Seed movements directly influence dosimetry which relates to treatment quality. We present a method that tracks all individual seeds over time allowing quantification of seed movements. This linking procedure was tested on transrectal ultrasound (TRUS) and cone-beam CT (CBCT) datasets of 699 patients. These datasets were acquired intraoperatively during a dynamic implantation procedure, that combines both imaging modalities. The procedure was subdivided in four automatic linking steps. (I) The Hungarian Algorithm was applied to initially link seeds in CBCT and the corresponding TRUS datasets. (II) Strands were identified and optimized based on curvature and linefits: non optimal links were removed. (III) The positions of unlinked seeds were reviewed and were linked to incomplete strands if within curvature- and distance-thresholds. (IV) Finally, seeds close to strands were linked, also if the curvature-threshold was violated. After linking the seeds an affine transformation was applied. The procedure was repeated until the results were stable or the 6th iteration ended. All results were visually reviewed for mismatches and uncertainties. Eleven implants showed a mismatch and in 12 cases an uncertainty was identified. On average the linking procedure took 42 ms per case. This accurate and fast method has the potential to be used for other time spans, like Day 30, and other imaging modalities. It can potentially be used during a dynamic implantation procedure to faster and better evaluate the quality of the permanent prostate implant.

Rapid Palatal Expansion in the absence of posterior cross-bite to intercept maxillary incisor crowding in the mixed dentition: a CBCT evaluation of spontaneous changes of untouched permanent molars.

PubMed

Rosa, M; Lucchi, P; Manti, G; Caprioglio, A

2016-12-01

The aim of this study was to investigate the reaction of untouched permanent molars following RPE, anchored on deciduous teeth in the early mixed dentition, aimed to solve maxillary anterior crowding in the absence of posterior cross-bite. A prospective clinical trial comprised 35 consecutive patients (20 males and 15 females) treated by the same orthodontist (MR). All patients showed crowding of the upper permanent incisors in the early mixed dentition in the absence of posterior cross-bite. RPE was anchored on second deciduous molars and on the deciduous canines. CBCT was taken before and after the removal of the RPE appliance. The transverse linear changes in width and the variation in the torque of the permanent molars were measured in the coronal plane. Relief of incisor crowding was found in all patients. The transverse width between permanent molars increased significantly. The apices of the upper permanent molars spontaneously expanded more than the crowns, while the opposite happened on the lower permanent molars. Moreover, the untouched upper permanent molars spontaneously uprighted palatally, while the lower permanent molars spontaneously uprighted buccally. The variation in the torque of the permanent molars mirrored transverse normal growth. In the early mixed dentition and in the absence of posterior cross-bite, it is possible to expand transversally the palate while uprighting the upper permanent molars in the opposite direction. RPE anchored on the deciduous teeth in the early mixed dentition, in the absence of posterior cross-bite, provides an "anticipation of transverse growth" and could be indicated to expand the anterior portion of the maxillary arch perimeter to solve upper incisor crowding.

A study on setting of the fatigue limit of temporary dental implants.

PubMed

Kim, M H; Cho, E J; Lee, J W; Kim, E K; Yoo, S H; Park, C W

2017-07-01

A temporary dental implant is a medical device which is temporarily used to support a prosthesis such as an artificial tooth used for restoring patient's masticatory function during implant treatment. It is implanted in the oral cavity to substitute for the role of tooth. Due to the aging and westernization of current Korean society, the number of tooth extraction and implantation procedures is increasing, leading to an increase in the use and development of temporary dental implants. Because an implant performs a masticatory function in place of a tooth, a dynamic load is repeatedly put on the implant. Thus, the fatigue of implants is reported to be the most common causes of the fracture thereof. According to the investigation and analysis of the current domestic and international standards, the standard for fatigue of implant fixtures is not separately specified. Although a test method for measuring the fatigue is suggested in an ISO standard, it is a standard for permanent dental implants. Most of the test standards for Korean manufacturers and importers apply 250 N or more based on the guidance for the safety and performance evaluation of dental implants. Therefore, this study is intended to figure out the fatigue standard which can be applied to temporary dental implants when measuring the fatigue according to the test method suggested in the permanent dental implant standard. The results determined that suitable fatigue standards of temporary dental implants should be provided by each manufacturer rather than applying 250 N. This study will be useful for the establishment of the fatigue standards and fatigue test methods of the manufacturers and importers of temporary dental implants.

Photon beam dose distributions for patients with implanted temporary tissue expanders

NASA Astrophysics Data System (ADS)

Asena, A.; Kairn, T.; Crowe, S. B.; Trapp, J. V.

2015-01-01

This study examines the effects of temporary tissue expanders (TTEs) on the dose distributions of photon beams in breast cancer radiotherapy treatments. EBT2 radiochromic film and ion chamber measurements were taken to quantify the attenuation and backscatter effects of the inhomogeneity. Results illustrate that the internal magnetic port present in a tissue expander causes a dose reduction of approximately 25% in photon tangent fields immediately downstream of the implant. It was also shown that the silicone elastomer shell of the tissue expander reduced the dose to the target volume by as much as 8%. This work demonstrates the importance for an accurately modelled high-density implant in the treatment planning system for post-mastectomy breast cancer patients.

Antibiotic prophylaxis in permanent pacemaker implantation: a prospective randomised trial.

PubMed Central

Mounsey, J P; Griffith, M J; Tynan, M; Gould, F K; MacDermott, A F; Gold, R G; Bexton, R S

1994-01-01

BACKGROUND--Pacemaker pocket infection is a potentially serious problem after permanent pacemaker implantation. Antibiotic prophylaxis is commonly prescribed to reduce the incidence of this complication, but current trial evidence of its efficacy is conflicting. A large prospective randomised trial was therefore performed of antibiotic prophylaxis in permanent pacemaker implantation. The intention was firstly to determine whether antibiotic prophylaxis is efficacious in these patients and secondly to identify which patients are at the highest risk of infection. METHODS--A prospective randomised open trial of flucloxacillin (clindamycin if the patient was allergic to penicillin) v no antibiotic was performed in a cohort of patients undergoing first implantation of a permanent pacing system over a 17 month period. Intravenous antibiotics were started at the time of implantation and continued for 48 hours. The trial endpoint was a repeat operation for an infective complication. RESULTS--473 patients were entered into a randomised trial. 224 received antibiotic prophylaxis and 249 received no antibiotics. A further 183 patients were not randomised but were treated according to the operator's preference (64 antibiotics, 119 no antibiotics); these patients are included only in the analysis of predictors of infection. Patients were followed up for a mean (SD) of 19(5) months. Among the patients in the randomised group there were nine infections requiring a repeat operation, all in the group not receiving antibiotic (P = 0.003). In the total patient cohort there were 13 infections, all but one in the non-antibiotic group (P = 0.006). Nine of the infections presented as erosion of the pulse generator or electrode, three as septicaemia secondary to Staphylococcus aureus, and one as a pocket abscess secondary to Staphylococcus epidermidis. Infections were significantly more common when the operator was inexperienced (< or = 100 previous patients), the operation was prolonged, or after a repeat operation for non-infective complications (principally lead displacement). Infection was not significantly more common in patients identified preoperatively as being at high risk (for example patients with diabetes mellitus, patients receiving long term steroid treatment), although there was a trend in this direction. CONCLUSIONS--Antibiotic prophylaxis significantly reduced the incidence of infective complications requiring a repeat operation after permanent pacemaker implantation. It is suggested that antibiotics should be used routinely. PMID:7833191

Prevalence and factors affecting use of long acting and permanent contraceptive methods in Jinka town, Southern Ethiopia: a cross sectional study.

PubMed

Mekonnen, Getachew; Enquselassie, Fikre; Tesfaye, Gezahegn; Semahegn, Agumasie

2014-01-01

In Ethiopia, knowledge of contraceptive methods is high though there is low contraceptive prevalence rate. This study was aimed to assess prevalence and associated factors of long acting and permanent contraceptive methods in Jinka town, southern Ethiopia. Community based cross sectional survey was conducted to assess the prevalence and factors affecting long acting and permanent methods of contraceptives utilization from March to April 2008. Eight hundred child bearing age women were participated in the quantitative study and 32 purposively selected focus group discussants were participated in the qualitative study. Face to face interview was used for data collection. Data were analyzed by SPSS version 13.0 statistical software. Descriptive statistics and logistic regression were computed to analyze the data. The prevalence of long acting and permanent contraceptive method was 7.3%. Three fourth (76.1%) of the women have ever heard about implants and implant 28 (50%) were the most widely used method. Almost two third of women had intention to use long acting and permanent methods. Knowledge of contraceptive and age of women have significant association with the use of long acting and permanent contraceptive methods. The overall prevalence of long acting and permanent contraceptive method was low. Knowledge of contraceptive and age of women have significant association with use of long acting and permanent contraceptive. Extensive health information should be provided.

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.

Nonexpansive immediate breast reconstruction using human acellular tissue matrix graft (AlloDerm).

PubMed

Salzberg, C Andrew

2006-07-01

Immediate breast reconstruction has become a standard of care following mastectomy for cancer, largely due to improved esthetic and psychologic outcomes achieved with this technique. However, the current historical standards--transverse rectus abdominis myocutaneous flap reconstruction and expander--implant surgery-still have limitations as regards patient morbidity, short-term body-image improvements, and even cost. To address these shortcomings, we employ a novel concept of human tissue replacement to enhance breast shape and provide total coverage, enabling immediate mound reconstruction without the need for breast expansion prior to permanent implant placement. AlloDerm (human acellular tissue matrix) is a human-derived graft tissue with extensive experience in various settings of skin and soft tissue replacement surgery. This report describes the success using acellular tissue matrix to provide total coverage over the prosthesis in immediate reconstruction, with limited muscle dissection. In this population, 49 patients (76 breasts) successfully underwent the acellular tissue matrix-based immediate reconstruction, resulting in durable breast reconstruction with good symmetry. These findings may predict that acellular tissue matrix-supplemented immediate breast reconstruction will become a new technique for the immediate reconstruction of the postmastectomy breast.

Immediate breast reconstruction-impact on radiation management.

PubMed Central

Shankar, Ravi A.; Nibhanupudy, J. Rao; Sridhar, Rajagopalan; Ashton, Cori; Goldson, Alfred L.

2003-01-01

Breast reconstruction is an option for women undergoing modified radical mastectomy due to a diagnosis of breast cancer. In certain patients, breast reconstruction is performed by insertion of a temporary tissue expander prior to the placement of permanent breast implants. Some of these patients, following mastectomy, may require chest wall irradiation to prevent loco regional relapse. The compatibility of radiation and tissue expanders placed in the chest wall is of major concern to the radiation oncologist. Clinically undetectable changes can occur in the tissue expander during the course of radiation therapy. This can lead to radiation treatment set-up changes, variation in tissue expansion resulting in unwanted cosmesis, and deviation from the prescribed radiation dose leading to over and/or under dosing of tumor burden. At Howard University hospital, a CT scan was utilized to evaluate the status of the temporary tissue expander during radiation treatment to enable us to prevent radiation treatment related complications resulting from dosimetric discrepancies. CT images of the tissue expander were obtained through the course of treatment. To avoid a 'geographic miss' the amount of fluid injected into the tissue expander was kept constant following patient's satisfaction with the size of the breast mound. The CT scans allowed better visualization of the prosthesis and its relation to the surrounding tumor bed. This technique ensured that anatomical changes occurring during radiation treatment, if any, were minimized. Repeated dosimetry evaluations showed no changes to the prescribed dose distribution. A CT of the reconstructed breast provides an important quality control. Further studies with greater number of patients are required for confirming this impact on radiation treatment. Images Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Figure 8 PMID:12749619

Mastectomy Skin Necrosis After Breast Reconstruction: A Comparative Analysis Between Autologous Reconstruction and Implant-Based Reconstruction.

PubMed

Sue, Gloria R; Lee, Gordon K

2018-05-01

Mastectomy skin necrosis is a significant problem after breast reconstruction. We sought to perform a comparative analysis on this complication between patients undergoing autologous breast reconstruction and patients undergoing 2-stage expander implant breast reconstruction. A retrospective review was performed on consecutive patients undergoing autologous breast reconstruction or 2-stage expander implant breast reconstruction by the senior author from 2006 through 2015. Patient demographic factors including age, body mass index, history of diabetes, history of smoking, and history of radiation to the breast were collected. Our primary outcome measure was mastectomy skin necrosis. Fisher exact test was used for statistical analysis between the 2 patient cohorts. The treatment patterns of mastectomy skin necrosis were then analyzed. We identified 204 patients who underwent autologous breast reconstruction and 293 patients who underwent 2-stage expander implant breast reconstruction. Patients undergoing autologous breast reconstruction were older, heavier, more likely to have diabetes, and more likely to have had prior radiation to the breast compared with patients undergoing implant-based reconstruction. The incidence of mastectomy skin necrosis was 30.4% of patients in the autologous group compared with only 10.6% of patients in the tissue expander group (P < 0.001). The treatment of this complication differed between these 2 patient groups. In general, those with autologous reconstructions were treated with more conservative means. Although 37.1% of patients were treated successfully with local wound care in the autologous group, only 3.2% were treated with local wound care in the tissue expander group (P < 0.001). Less than half (29.0%) of patients in the autologous group were treated with an operative intervention for this complication compared with 41.9% in the implant-based group (P = 0.25). Mastectomy skin necrosis is significantly more likely to occur after autologous breast reconstruction compared with 2-stage expander implant-based breast reconstruction. Patients with autologous reconstructions are more readily treated with local wound care compared with patients with tissue expanders, who tended to require operative treatment of this complication. Patients considering breast reconstruction should be counseled appropriately regarding the differences in incidence and management of mastectomy skin necrosis between the reconstructive options.

Risk Factors For Bradycardia Requiring Pacemaker Implantation In Patients With Atrial Fibrillation

PubMed Central

Barrett, Tyler W.; Abraham, Robert L.; Jenkins, Cathy A.; Russ, Stephan; Storrow, Alan B.; Darbar, Dawood

2012-01-01

Symptomatic bradycardia may complicate atrial fibrillation (AF) and necessitate a permanent pacemaker. Identifying patients at increased risk for symptomatic bradycardia may reduce associated morbidities and healthcare costs. We investigated predictors for developing bradycardia requiring a permanent pacemaker among AF patients. We reviewed records of all patients treated for AF/flutter in an academic hospital’s emergency department from 8/1/2005 to 8/30/2008. We determined survival and presence of a pacemaker as of 11/1/2011. Cases were defined as patients with pacemakers placed for bradycardia after their AF diagnoses. Patients without a pacemaker who were followed at our hospital comprised the controls. We identified a priori variables for the logistic regression analysis. We fit a post-hoc model adjusting for AF type and atrioventricular nodal blocker (AVN) use. Of the 362 patients in our cohort, 119 cases had permanent pacemakers implanted for bradycardia subsequent to AF diagnosis and 243 controls were alive without a pacemaker. Median and interquartile range follow-up time was 4.5 (3.8 – 5.4) years. Odds ratios and 95% confidence intervals were determined for age at time of AF diagnosis (1.02 [1, 1.04]), female (1.58 [0.95, 2.63]), prior heart failure (2.72 [1.47, 5.01]), and African-American (0.33 [0.12, 0.94]). Post-hoc model identified permanent AF (2.99 [1.61, 5.57]) and AVN use (1.43 [0.85, 2.4]). In conclusion, among AF patients, heart failure and permanent AF each nearly triple the odds of developing bradycardia requiring a permanent pacemaker; while not statistically significant, our results suggest that women are more likely and African-Americans less likely to develop bradycardia requiring pacemaker implantation. PMID:22840846

[Long-term effects of permanent pacemaker implantation on tricuspid valve regurgitation].

PubMed

Ren, Chong-lei; Wang, Yao; Wang, Rong; Li, Bo-jun; Geng, Ren-yi; Gao, Chang-qing

2012-08-14

To explore the long-term effects of permanent pacemaker implantation (PPI) on tricuspid valve regurgitation (TR) in Chinese patients so as to determine the incidence and related factors, evaluate its effects on heart structure and function and ascertain the exact mechanism of TR after PPI. A total of 430 patients undergoing permanent pacemaker replacement at our hospital between January 2000 and June 2011 were recruited. The patients with isolated atrial lead implantation procedures, significant heart valve disease or chronic obstructive pulmonary disease were excluded. The data of 108 patients who had Doppler echocardiograms performed before the first pacemaker implantation procedure and this pacemaker replacement procedure were obtained and retrospectively analyzed. According to the post-implant grade of TR, the patients were divided into two groups: normal tricuspid (n = 79) and abnormal tricuspid (n = 29). Their clinical characteristics and echocardiographic data between two groups were analyzed and compared. The mean follow-up time (from the first pacemaker implantation) was (13 ± 6) years (range: 4 - 34). Among 108 patients with initially normal tricuspid post-implant, 29 patients (26.9%) developed significant TR during the follow-up. In comparison to those in normal tricuspid group, the patients in abnormal tricuspid group had a longer time from the first pacemaker implantation ((16 ± 7) vs (12 ± 5) years, P = 0.003), more transtricuspid leads (1.31 ± 0.66 vs 1.10 ± 0.30, P = 0.026), larger right atrial size ((38 ± 7) vs (35 ± 4) mm, P = 0.028) and higher prevalence of mild TR and mitral valve regurgitation (MR) pre-implantation (TR: 21% vs 4%, P = 0.015, MR: 28% vs 5%, P = 0.003). The size of right atrium, right ventricle and left atrium in abnormal tricuspid group were more than those in normal tricuspid group. The prevalence of significant MR post-implantation in abnormal tricuspid group was higher than that in normal tricuspid group. The ejection fraction in abnormal tricuspid group was lower than that in normal tricuspid group during the follow-up. Abnormal TR after PPI during a long-term follow-up is quite common. The related factors include the time interval from the first pacemaker implantation, number of transtricuspid lead, right atrial size, mild TR and MR pre-implantation.

Pacemaker Use Following Heart Transplantation

PubMed Central

Mallidi, Hari R.; Bates, Michael

2017-01-01

Background: The incidence of permanent pacemaker implantation after orthotopic heart transplantation has been reported to be 2%-24%. Transplanted hearts usually exhibit sinus rhythm in the operating room following reperfusion, and most patients do not exhibit significant arrhythmias during the postoperative period. However, among the patients who do exhibit abnormalities, pacemakers may be implanted for early sinus node dysfunction but are rarely used after 6 months. Permanent pacing is often required for atrioventricular block. A different cohort of transplant patients presents later with bradycardia requiring pacemaker implantation, reported to occur in approximately 1.5% of patients. The objectives of this study were to investigate the indications for pacemaker implantation, compare the need for pacemakers following bicaval vs biatrial anastomosis, and examine the long-term outcomes of heart transplant patients who received pacemakers. Methods: For this retrospective, case-cohort, single-institution study, patients were identified from clinical research and administrative transplant databases. Information was supplemented with review of the medical records. Standard statistical techniques were used, with chi-square testing for categorical variables and the 2-tailed t test for continuous variables. Survival was compared with the use of log-rank methods. Results: Between January 1968 and February 2008, 1,450 heart transplants were performed at Stanford University. Eighty-four patients (5.8%) were identified as having had a pacemaker implanted. Of these patients, 65.5% (55) had the device implanted within 30 days of transplantation, and 34.5% (29) had late implantation. The mean survival of patients who had an early pacemaker implant was 6.4 years compared to 7.7 years for those with a late pacemaker implant (P<0.05). Sinus node dysfunction and heart block were the most common indications for pacemaker implantation. Starting in 1997, a bicaval technique was used for implantation. The incidence of pacemaker implantation by technique was 2.0% for bicaval and 9.1% for biatrial (P=0.001). Significantly more rejection episodes occurred in the pacemaker group (2.67 ± 2.18) compared with the no-pacemaker group (2.01 ± 2.05) (P<0.05). Conclusion: Our results show a decreased pacemaker need after bicaval anastomosis and that more patients who needed a pacemaker after transplantation had a pretransplant diagnosis of ischemic cardiomyopathy. In our cohort, the need for a permanent pacemaker was also associated with older donor grafts and an increase in the number of treated rejection episodes. PMID:28331443

Similarities and differences in coatings for magnesium-based stents and orthopaedic implants

PubMed Central

Ma, Jun; Thompson, Marc; Zhao, Nan; Zhu, Donghui

2016-01-01

Magnesium (Mg)-based biodegradable materials are promising candidates for the new generation of implantable medical devices, particularly cardiovascular stents and orthopaedic implants. Mg-based cardiovascular stents represent the most innovative stent technology to date. However, these products still do not fully meet clinical requirements with regards to fast degradation rates, late restenosis, and thrombosis. Thus various surface coatings have been introduced to protect Mg-based stents from rapid corrosion and to improve biocompatibility. Similarly, different coatings have been used for orthopaedic implants, e.g., plates and pins for bone fracture fixation or as an interference screw for tendon-bone or ligament-bone insertion, to improve biocompatibility and corrosion resistance. Metal coatings, nanoporous inorganic coatings and permanent polymers have been proved to enhance corrosion resistance; however, inflammation and foreign body reactions have also been reported. By contrast, biodegradable polymers are more biocompatible in general and are favoured over permanent materials. Drugs are also loaded with biodegradable polymers to improve their performance. The key similarities and differences in coatings for Mg-based stents and orthopaedic implants are summarized. PMID:27695671

Ridge expansion and immediate placement with piezosurgery and screw expanders in atrophic maxillary sites: two case reports.

PubMed

Kelly, Andrew; Flanagan, Dennis

2013-02-01

Endosseous dental implants may require bone augmentation before implant placement. Herein is described an approach to edentulous ridge expansion with the use of piezosurgery and immediate placement of implants. This may allow for a shortened treatment time and the elimination of donor-site morbidity. Two cases are reported. This technique uses a piezoelectric device to cut the crestal and proximal facial cortices. Space is then created with motorized osteotomes to widen the split ridge. This technique allows for expansion of narrow, anatomically limiting, atrophic ridges, creating space for immediate implant placement. The facial and lingual cortices provide support with vital osteocytes for osteogenesis. The 2 patients presented had adequate bone height for implant placement but narrow edentulous ridges. In patient 1 at site #11, the ridge crest was 3.12 mm thick and was expanded to accept a 4.3 mm × 13 mm implant. The resulting ridge width was 8.88 mm, which was verified using cone beam computerized tomography (CBCT). In patient 2 at site #8 and site #9, the narrow ridge was expanded using the same technique to accept 2 adjacent 3.5 mm × 14 mm implants. The implants were restored to a functional and esthetic outcome.

Do we need to establish guidelines for patients with neuromodulation implantable devices, including spinal cord stimulators undergoing nonspinal surgeries?

PubMed Central

Ghaly, Ramsis F.; Tverdohleb, Tatiana; Candido, Kenneth D.; Knezevic, Nebojsa Nick

2016-01-01

Background: Spinal cord stimulation is currently approved to treat chronic intractable pain of the trunk and limbs. However, such implantable electronic devices are vulnerable to external electrical currents and magnetic fields. Within the hospitals and modern operating rooms (ORs), there is an abundance of electrical devices and other types of equipment that could interfere with such devices. Despite the increasing number of patients with neuromodulation implantable devices, there are no written guidelines available or consensus of cautions for such patients undergoing unrelated surgery. Case Descriptions: A 60-year-old female with a permanent St. Jude's spinal cord stimulator (SCS) presented for open total abdominal hysterectomy. Both the anesthesia and gynecology staffs were aware of the device presence, but were unaware of any precautions regarding intraoperative management. The device was found to be nonmagnetic resonance imaging compatible, and bipolar cautery was used instead of monopolar cautery. A 59-year-old female with a 9-year-old permanent Medtronic SCS, presented for right total hip arthroplasty. The device was switched off prior to entering the OR, bipolar cautery was used, and grounding pads were placed away from her battery site. In each case, the manufacturer's representative was contacted preoperative. Both surgeries proceeded uneventfully. Conclusions: The Food and Drug Administration safety information manual warns about the use of diathermy, concomitant implanted stimulation devices, lithotripsy, external defibrillation, radiation therapy, ultrasonic scanning, and high-output ultrasound, all of which can lead to permanent implant damage if not turned off prior to undertaking procedures. Lack of uniform guidelines makes intraoperative management, as well as remote anesthesia care of patients with previously implanted SCSs unsafe. PMID:26958424

Influence of Prostatic Edema on {sup 131}CS Permanent Prostate Seed Implants: A Dosimetric and Radiobiological Study

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

Kehwar, Than S., E-mail: kehwarts@upmc.ed; Jones, Heather A.; Huq, M. Saiful

2011-06-01

Purpose: To study the influence of prostatic edema on postimplant physical and radiobiological parameters using {sup 131}Cs permanent prostate seed implants. Methods and Materials: Thirty-one patients with early prostate cancer who underwent {sup 131}Cs permanent seed implantation were evaluated. Dose-volume histograms were generated for each set of prostate volumes obtained at preimplantation and postimplantion days 0, 14, and 28 to compute quality indices (QIs) and fractional doses at level x (FD{sub x}). A set of equations for QI, FD{sub x}, and biologically effective doses at dose level D{sub x} (BED{sub x}) were defined to account for edema changes with timemore » after implant. Results: There were statistically significant differences found between QIs of pre- and postimplant plans at day 0, except for the overdose index (ODI). QIs correlated with postimplant time, and FD{sub x} was found to increase with increasing postimplant time. With the effect of edema, BED at different dose levels showed less improvement due to the short half-life of {sup 131}Cs, which delivers about 85% of the prescribed dose before the prostate reaches its original volume due to dissipation of edema. Conclusions: Results of the study show that QIs, FD{sub x}, and BEDs at the level of D{sub x} changed from preneedle plans to postimplant plans and have statistically significant differences (p < 0.05), except for the ODI (p = 0.106), which suggests that at the time of {sup 131}C seed implantation, the effect of edema must be accounted for when defining the seed positions, to avoid the possibility of poor dosimetric and radiobiologic results for {sup 131}Cs seed implants.« less

Permanent pacemaker insertion following isolated aortic valve replacement before and after the introduction of TAVI.

PubMed

Kogan, Alexander; Sternik, Leonid; Beinart, Roy; Shalabi, Amjad; Glikson, Michael; Spiegelstein, Danny; Levin, Shany; Raanani, Ehud

2015-04-01

Permanent pacemaker (PPM) implantation is required in 3-12% of all patients undergoing surgical aortic valve replacement (AVR). Our aim was to evaluate the contemporary incidence and impact of the introduction of transcatheter aortic valve implantation (TAVI) for PPM insertion after isolated AVR. Since 2004, during a 10-year period, a total of 858 patients underwent isolated AVR at our institution. Forty-one patients with PPM before operation were excluded from the study and 817 patients were included in the statistical analysis. Of these, 20 patients (2.45%) developed significant conduction disorders, leading to PPM implantation within 120 days postoperatively. Patients were further divided into two groups. Before (Group I: June 2004 to September 2008) and after (Group II: October 2008 to May 2014) the introduction of the TAVI program. There were 343 patients in Group I and 475 patients in Group II. The incidence of PPM implantation decreased from 3.79% (13 patients) in Group I to 1.47% (seven patients) in Group II (P < 0.001). Risk factors for permanent pacing identified by univariate analysis were: Group I (before introducing TAVI program), pulmonary hypertension, preoperative anemia, age older than 75 years, and previous myocardial infarction. Multivariate analysis identified Group I (before introducing TAVI program; P < 0.005; odds ratio [OR] 15.2, 95% confidence interval [CI] 6.3-19.9) and pulmonary hypertension (P < 0.005; OR 12.5, 95% CI 3.2-18.3) to be significant. Irreversible atrio-ventricular block or symptomatic bradycardia requiring PPM implantation is a relatively rare complication. The incidence of PPM implantation after isolated surgical AVR decreased in a contemporary setting after the introduction of the TAVI program. ©2015 Wiley Periodicals, Inc.

Sacral neuromodulation in the treatment of the unstable bladder.

PubMed

Bosch, J L

1998-07-01

Sacral neuromodulation as a treatment for urge incontinence in patients with an unstable bladder is the subject of ongoing clinical studies. Although approximately 75% of the patients treated with a permanent sacral foramen electrode implant have experienced significant improvements, it is now also clear that there is an initial failure rate of about 25%. Recent studies have pointed out the importance of improved patient selection on the basis of sex differences, urodynamic parameters and psychological factors. Also, newer forms of test stimulation and permanent electrode implantation are being explored in an effort to improve on the present results.

MRI induced torque and demagnetization in retention magnets for a bone conduction implant.

PubMed

Jansson, Karl-Johan Fredén; Håkansson, Bo; Reinfeldt, Sabine; Taghavi, Hamidreza; Eeg-Olofsson, Måns

2014-06-01

Performing magnetic resonance imaging (MRI) examinations in patients who use implantable medical devices involve safety risks both for the patient and the implant. Hearing implants often use two permanent magnets, one implanted and one external, for the retention of the external transmitter coil to the implanted receiver coil to achieve an optimal signal transmission. The implanted magnet is subjected to both demagnetization and torque, magnetically induced by the MRI scanner. In this paper, demagnetization and a comparison between measured and simulated induced torque is studied for the retention magnet used in a bone conduction implant (BCI) system. The torque was measured and simulated in a uniform static magnetic field of 1.5 T. The magnetic field was generated by a dipole electromagnet and permanent magnets with two different types of coercive fields were tested. Demagnetization and maximum torque for the high coercive field magnets was 7.7% ± 2.5% and 0.20 ± 0.01 Nm, respectively and 71.4% ± 19.1% and 0.18 ± 0.01 Nm for the low coercive field magnets, respectively. The simulated maximum torque was 0.34 Nm, deviating from the measured torque in terms of amplitude, mainly related to an insufficient magnet model. The BCI implant with high coercive field magnets is believed to be magnetic resonance (MR) conditional up to 1.5 T if a compression band is used around the skull to fix the implant. This is not approved and requires further investigations, and if removal of the implant is needed, the surgical operation is expected to be simple.

Treatment of Prominent Ears with an Implantable Clip System: A Pilot Study.

PubMed

Kang, Norbert V; Kerstein, Ryan L

2016-03-01

The earFold™ implantable clip system is a new treatment for prominent ears using an implant made from nickel-titanium alloy, forged into a predetermined shape. The implant is fixed to the cartilage then released, causing the cartilage to fold back. The study aimed to test the safety and behaviour of the implant in vivo. This was a Phase 1, prospective, nonrandomised study. Thirty-nine patients were recruited, from 7 to 57 years of age (22 adults and 17 children). Thirty-seven patients were followed up for a minimum of 18 months. A total of 131 implants was used to treat 75 ears. All treatments were performed under local anaesthetic. Eighteen patients asked for their implants to be left in place permanently. Twenty-one patients agreed to have their implants removed at 6, 12, or 18 months after insertion. Complications affected 8 patients and included extrusion, infection, hypertrophic scarring, and Spock-ear formation. No new complications have arisen in any of the patients since the conclusion of the study, up to a maximum of 47 months. Patients were overwhelmingly satisfied with the outcome of treatment. earFold can be used as a permanent implant to correct prominence of the human ear. It is best suited for treating prominent ears with a poorly formed or absent antihelical fold. The procedure is quick and predictable with a complication rate comparable to suture-based otoplasty techniques. © 2015 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

Treatment of Prominent Ears with an Implantable Clip System: A Pilot Study

PubMed Central

Kang, Norbert V.; Kerstein, Ryan L.

2016-01-01

Background The earFold™ implantable clip system is a new treatment for prominent ears using an implant made from nickel-titanium alloy, forged into a predetermined shape. The implant is fixed to the cartilage then released, causing the cartilage to fold back. Objectives The study aimed to test the safety and behaviour of the implant in vivo. Methods This was a Phase 1, prospective, nonrandomised study. Thirty-nine patients were recruited, from 7 to 57 years of age (22 adults and 17 children). Thirty-seven patients were followed up for a minimum of 18 months. A total of 131 implants was used to treat 75 ears. All treatments were performed under local anaesthetic. Results Eighteen patients asked for their implants to be left in place permanently. Twenty-one patients agreed to have their implants removed at 6, 12, or 18 months after insertion. Complications affected 8 patients and included extrusion, infection, hypertrophic scarring, and Spock-ear formation. No new complications have arisen in any of the patients since the conclusion of the study, up to a maximum of 47 months. Patients were overwhelmingly satisfied with the outcome of treatment. Conclusions earFold can be used as a permanent implant to correct prominence of the human ear. It is best suited for treating prominent ears with a poorly formed or absent antihelical fold. The procedure is quick and predictable with a complication rate comparable to suture-based otoplasty techniques. PMID:26673575

The influence of bone damage on press-fit mechanics.

PubMed

Bishop, Nicholas E; Höhn, Jan-Christian; Rothstock, Stephan; Damm, Niklas B; Morlock, Michael M

2014-04-11

Press-fitting is used to anchor uncemented implants in bone. It relies in part on friction resistance to relative motion at the implant-bone interface to allow bone ingrowth and long-term stability. Frictional shear capacity is related to the interference fit of the implant and the roughness of its surface. It was hypothesised here that a rough implant could generate trabecular bone damage during implantation, which would reduce its stability. A device was constructed to simulate implantation by displacement of angled platens with varying surface finishes (polished, beaded and flaked) onto the surface of an embedded trabecular bone cube, to different nominal interferences. Push-in (implantation) and Pull-out forces were measured and micro-CT scans were made before and after testing to assess permanent bone deformation. Depth of permanent trabecular bone deformation ('damage'), Pull-out force and Radial force all increased with implantation displacement and with implantation force, for all surface roughnesses. The proposed hypothesis was rejected, since primary stability did not decrease with trabecular bone damage. In fact, Pull-out force linearly increased with push-in force, independently of trabecular bone damage or implant surface. This similar behaviour for the different surfaces might be explained by the compaction of bone into the surfaces during push-in so that Pull-out resistance is governed by bone-on-bone, rather than implant surface-on-bone friction. The data suggest that maximum stability is achieved for the maximum implantation force possible (regardless of trabecular bone damage or surface roughness), but this must be limited to prevent periprosthetic cortical bone fracture, patient damage and component malpositioning. Copyright © 2014 Elsevier Ltd. All rights reserved.

Effects of Cement, Abutment Surface Pretreatment, and Artificial Aging on the Force Required to Detach Cantilever Fixed Dental Prostheses from Dental Implants.

PubMed

Kappel, Stefanie; Chepura, Taras; Schmitter, Marc; Rammelsberg, Peter; Rues, Stefan

To examine the in vitro effects of different cements, abutment surface preconditioning, and artificial aging on the maximum tensile force needed to detach cantilever fixed dental prostheses (FDPs) from dental implants with titanium abutments. A total of 32 tissue-level implants were combined with standardized titanium abutments. For each test group, eight cantilever FDPs were fabricated using selective laser melting (cobalt-chromium [CoCr] alloy). The inner surfaces of the cantilever FDPs and half of the abutments were sandblasted and then joined by use of four different cements (two permanent and two semi-permanent) in two different amounts per cement. Subgroups were tested after either artificial aging (thermocycling and chewing simulation) or 3 days of water storage. Finally, axial pull off-tests were performed for each abutment separately. Cement type and surface pretreatment significantly affected decementation behavior. The highest retention forces (approximately 1,200 N) were associated with sandblasted abutments and permanent cements. With unconditioned abutments, temporary cements (Fu < 100 N), as well as glass-ionomer cement (Fu ≈ 100 N), resulted in rather low retention forces. Zinc phosphate cement guaranteed high retention forces. After aging, retention was sufficient only for cementation with zinc phosphate cement and for the combination of sandblasted abutments and glass-ionomer cement. When glass-ionomer cement is used to fix cantilever FDPs on implants, sandblasting of standard titanium abutments may help prevent loss of retention. Retention forces were still high for FDPs fixed with zinc phosphate cement, even when the abutments were not pretreated. Use of permanent cements only, however, is recommended to prevent unwanted loosening of cantilever FDPs.

Management of pain secondary to temporomandibular joint syndrome with peripheral nerve stimulation.

PubMed

Rodriguez-Lopez, Manuel J; Fernandez-Baena, Mariano; Aldaya-Valverde, Carlos

2015-01-01

Temporomandibular joint syndrome, or Costen syndrome, is a clinically diagnosed disorder whose most common symptoms include joint pain and clicking, difficulty opening the mouth, and temporomandibular joint discomfort. The temporomandibular joint (TMJ) is supplied by the auriculotemporal nerve, a collateral branch of the mandibular nerve (the V3 branch of the trigeminal nerve). The aim of this study is to assess the effectiveness and safety of permanent peripheral nerve stimulation to relieve TMJ pain. This case series is a prospective study. Pain Unit of a regional universitary hospital. The study included 6 female patients with temporomandibular pain lasting from 2 to 8 years that did not respond to intraarticular local anesthetic and corticoid injections. After a positive diagnostic block test, the patients were implanted with quadripolar or octapolar leads in the affected preauricular region for a 2-week stimulation test phase, after which the leads were connected to a permanent implanted pulse generator. Results of the visual analog scale, SF-12 Health Survey, Brief Pain Inventory, and drug intake were recorded at baseline and at 4, 12, and 24 weeks after the permanent implant. Five out of 6 patients experienced pain relief exceeding 80% (average 72%) and received a permanent implant. The SF-12 Health Survey results were very positive for all specific questions, especially items concerning the physical component. Patients reported returning to normal physical activity and rest at night. Four patients discontinued their analgesic medication and 1 patient reduced their gabapentin dose by 50%. Sample size; impossibility of placebo control. Patients affected with TMJ syndrome who do not respond to conservative treatments may find a solution in peripheral nerve stimulation, a simple technique with a relatively low level of complications.

Novel self-expandable, stent-based transcatheter pulmonic valve: a preclinical animal study.

PubMed

Kim, Gi Beom; Lim, Hong-Gook; Kim, Yong Jin; Choi, Eun Young; Kwon, Bo Sang; Jeong, Saeromi

2014-04-15

Because transcatheter implantation of pulmonary valve is indicated for limited-size dysfunctional right ventricular outflow tract only as a balloon-expandable stent, we investigated the feasibility of a large-diameter self-expandable valved stent and the durability of the valve after >6 months. We made a nitinol-wire-based, self-expandable valved stent with leaflets made from porcine pericardium. The porcine pericardium was treated with α-galactosidase, glutaraldehyde, and glycine after decellularization. After cutting the inguinal or cervical area, we implanted a valved stent in 12 sheep through the femoral or jugular vein by using an 18-Fr delivery catheter, controlling the catheter handles and hook block under fluoroscopic and echocardiographic guidance. The mean body weight of sheep was 43.9 kg. We successfully implanted valved stents (diameter: 24 mm in 7 sheep, 26 mm in 5 sheep) in good position in 8 sheep, in the main pulmonary artery (PA) in 2 sheep, and in the right ventricular outlet tract (RVOT) in 2 sheep. We sacrificed 8 sheep (6 sheep in good position, 1 sheep in the main PA, and 1 sheep in the RVOT) after >6 months. Five of the 6 sheep implanted in good position showed well-preserved valve morphology at the time of sacrifice. Histologic findings after routine sacrifice showed well-maintained collagen wave structure and no visible calcification in all explanted valve leaflets. Transcatheter implantation of a nitinol-wire-based, self-expandable valved stent in the pulmonic valve was feasible, and stents implanted in good position showed well-preserved valve leaflets with functional competence in the mid-term results. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Recent advances in pacemaker and implantable defibrillator therapy for young patients.

PubMed

Walsh, Edward P; Cecchin, Frank

2004-03-01

This review is intended to highlight major clinical advances over the past year related to (1). biventricular pacing as a treatment for dilated myopathy, (2). growing clinical experience with implantable cardioverter defibrillators in pediatrics, (3). technical advances in standard antibradycardia pacing, and (4). an appraisal of the newly updated ACC/AHA/NASPE guidelines for device implant in children and adolescents. Complex rhythm devices are being used more frequently in children. Biventricular pacing to improve ventricular contractility is a rapidly evolving technology that has now been applied to children and young adults with intraventricular conduction delay, such as bundle branch block after cardiac surgery. Implantable defibrillators are also being used for an expanding list of conditions, although lead dysfunction is seen as a fairly common complication in active young patients. Guidelines for device implantation have been developed, but the weight of evidence remains somewhat limited by the paucity of pediatric data in this field. Thanks to refinements in lead design and generator technology, coupled with rapidly expanding clinical indications, pacemakers and implantable defibrillators have become increasingly important components of cardiac therapy for young patients. Expanded multicenter clinical studies will be needed to develop more objective guidelines for use of this advanced technology.

Dynamic Pain Phenotypes are Associated with Spinal Cord Stimulation-Induced Reduction in Pain: A Repeated Measures Observational Pilot Study.

PubMed

Campbell, Claudia M; Buenaver, Luis F; Raja, Srinivasa N; Kiley, Kasey B; Swedberg, Lauren J; Wacnik, Paul W; Cohen, Steven P; Erdek, Michael A; Williams, Kayode A; Christo, Paul J

2015-07-01

Spinal cord stimulation (SCS) has become a widely used treatment option for a variety of pain conditions. Substantial variability exists in the degree of benefit obtained from SCS and patient selection is a topic of expanding interest and importance. However, few studies have examined the potential benefits of dynamic quantitative sensory testing (QST) to develop objective measures of SCS outcomes or as a predictive tool to help patient selection. Psychological characteristics have been shown to play an important role in shaping individual differences in the pain experience and may aid in predicting responses to SCS. Static laboratory pain-induction measures have also been examined in their capacity for predicting SCS outcomes. The current study evaluated clinical, psychological and laboratory pain measures at baseline, during trial SCS lead placement, as well as 1 month and 3 months following permanent SCS implantation in chronic pain patients who received SCS treatment. Several QST measures were conducted, with specific focus on examination of dynamic models (central sensitization and conditioned pain modulation [CPM]) and their association with pain outcomes 3 months post SCS implantation. Results suggest few changes in QST over time. However, central sensitization and CPM at baseline were significantly associated with clinical pain at 3 months following SCS implantation, controlling for psycho/behavioral factors and pain at baseline. Specifically, enhanced central sensitization and reduced CPM were associated with less self-reported pain 3 months following SCS implantation. These findings suggest a potentially important role for dynamic pain assessment in individuals undergoing SCS, and hint at potential mechanisms through which SCS may impart its benefit. Wiley Periodicals, Inc.

A Systematic Review and Head-to-Head Meta-Analysis of Outcomes following Direct-to-Implant versus Conventional Two-Stage Implant Reconstruction.

PubMed

Basta, Marten N; Gerety, Patrick A; Serletti, Joseph M; Kovach, Stephen J; Fischer, John P

2015-12-01

Innovative approaches to reconstruction have ushered in an era of breast reconstruction in which direct-to-implant procedures can provide an immediately reconstructed breast. Balancing the benefits against its technical challenges is vital. The authors evaluated the safety and efficacy of using direct-to-implant versus conventional two-stage reconstruction through a systematic meta-analysis. A literature search identified all articles published after 1999 involving prosthetic-based breast reconstruction as a two-stage tissue expander/implant or direct-to-implant technique. The primary outcomes of interest, including implant loss, capsular contracture, reoperation, and infection, were analyzed by means of head-to-head meta-analysis. Thirteen studies involving 5216 breast reconstructions were included. The average patient age was 47.2 ± 1.0 years, the average body mass index was 24.9 ± 0.8 mg/k2, and the average follow-up was 40.8 months. Wound infection, seroma, and capsular contracture risk were similar between groups. However, direct-to-implant reconstruction was associated with a higher risk for skin flap necrosis (OR, 1.43; p = 0.01; I2 = 51 percent) and reoperation (OR, 1.25; p = 0.04; I2 = 43 percent). Ultimately, the risk for implant loss was nearly two-fold higher with direct-to-implant reconstruction compared with tissue expander/implant reconstruction (OR, 1.87; p = 0.04; I2 = 33 percent). Although direct-to-implant and two-stage tissue expander/implant reconstruction are successful approaches, this meta-analysis demonstrates significantly greater risk of flap necrosis and implant failure with direct-to-implant reconstruction. The authors' findings suggest that the critical component of patient selection is judgment of mastectomy flap tissue quality. These findings can enhance the risk counseling process and highlight the need for additional investigations to optimize outcomes.

SU-F-19A-11: Retrospective Evaluation of Thermal Coverage by Thermobrachytherapy Seed Arrangements of Clinical LDR Prostate Implants

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

Warrell, G; Shvydka, D; Chen, C

Purpose: The superiority of a properly-administered combination of radiation therapy and hyperthermia over radiation alone in treatment of human cancers has been demonstrated in multiple studies examining radiobiology, local control, and survival. Unfortunately, hyperthermia is not yet a common modality in oncology practice, due in part to the technical difficulty of heating a deep-seated target volume to sufficient temperature. To address this problem, our group has invented a thermobrachytherapy (TB) seed based on a commonly-used low dose-rate permanent brachytherapy seed for implant in solid tumors. Instead of the tungsten radiographic marker of the standard seed, the TB seed contains onemore » of a self-regulating ferromagnetic alloy. Placement of a patient implanted with such seeds in an oscillating magnetic field generates heat via induction of eddy currents. We present the results of studies of the capability of clinically-realistic TB seed arrangements to adequately heat defined target volumes. Methods: Seed distributions for several past LDR prostate permanent implant brachytherapy patients were reproduced in the finite element analysis software package COMSOL Multiphysics 4.4, with the difference that TB seeds were modelled, rather than the radiation-only seeds actually used for their treatments. The implant geometries were mainly of the modified peripheral loading type; a range of prostatic volumes and blood perfusion rates likely to be seen in a clinical setting were examined. Results: According to the simulations, when distributed to optimize radiation dose, TB seeds also produce sufficient heat to provide thermal coverage of the target given proper selection of the magnetic field strength. However, the thermal distributions may be improved by additional use of hyperthermia-only seeds. Conclusion: A dual-modality seed intended as an alternative to and using the same implantation apparatus and technique as the standard LDR permanent implant seed has been successfully evaluated for its ability to provide sufficient hyperthermia in clinically-realistic implants. This work was partially supported by the National Institutes of Health (NIH) STTR Grant No. R41 CA153631-01A1.« less

A virtual fluoroscopy system to verify seed positioning accuracy during prostate permanent seed implants.

PubMed

Sarkar, V; Gutierrez, A N; Stathakis, S; Swanson, G P; Papanikolaou, N

2009-01-01

The purpose of this project was to develop a software platform to produce a virtual fluoroscopic image as an aid for permanent prostate seed implants. Seed location information from a pre-plan was extracted and used as input to in-house developed software to produce a virtual fluoroscopic image. In order to account for differences in patient positioning on the day of treatment, the user was given the ability to make changes to the virtual image. The system has been shown to work as expected for all test cases. The system allows for quick (on average less than 10 sec) generation of a virtual fluoroscopic image of the planned seed pattern. The image can be used as a verification tool to aid the physician in evaluating how close the implant is to the planned distribution throughout the procedure and enable remedial action should a large deviation be observed.

Percutaneous transcatheter aortic valve implantation for degenerated surgical bioprostheses: the first case series in Asia with one-year follow-up.

PubMed

Chiam, Paul Toon-Lim; Ewe, See-Hooi; Soon, Jia-Lin; Ho, Kay-Woon; Sin, Yong-Koong; Tan, Swee-Yaw; Lim, Soo-Teik; Koh, Tian-Hai; Chua, Yeow-Leng

2016-07-01

Percutaneous transcatheter aortic valve implantation (TAVI) has become an established therapy for inoperable and high-surgical-risk patients with severe aortic stenosis. Although TAVI in patients with degenerated surgical aortic bioprostheses (i.e. valve-in-valve TAVI) is increasingly reported in Western studies, such data is lacking in Asian patients. We describe the initial experience of valve-in-valve TAVI in Asia. Eight patients who underwent valve-in-valve TAVI due to degenerated aortic bioprostheses were enrolled. The mechanism of bioprosthetic valve failure was stenotic, regurgitation or mixed. All procedures were performed via transfemoral arterial access, using the self-expanding CoreValve prosthesis or balloon-expandable SAPIEN XT prosthesis. The mean age of the patients was 71.6 ± 13.2 years and five were male. Mean duration to surgical bioprosthesis degeneration was 10.2 ± 4.1 years. Valve-in-valve TAVI was successfully performed in all patients. CoreValve and SAPIEN XT prostheses were used in six and two patients, respectively. There were no deaths, strokes or permanent pacemaker requirement at 30 days, with one noncardiac mortality at one year. All patients experienced New York Heart Association functional class improvement. Post-procedure mean pressure gradients were 20 ± 11 mmHg and 22 ± 8 mmHg at 30 days and one year, respectively. Residual aortic regurgitation (AR) of more than mild severity occurred in one patient at 30 days. At one year, only one patient had mild residual AR. In our experience of valve-in-valve TAVI, procedural success was achieved in all patients without adverse events at 30 days. Good clinical and haemodynamic outcomes were sustained at one year. Copyright © Singapore Medical Association.

Vestibular sensory functional status of cochlear implanted ears versus non-implanted ears in bilateral profound deaf adults.

PubMed

Cozma, Romică Sebastian; Dima-Cozma, Lucia Corina; Rădulescu, Luminiţa Mihaela; Hera, Maria Cristina; Mârţu, Cristian; Olariu, Raluca; Cobzeanu, Bogdan Mihail; Bitere, Oana Roxana; Cobzeanu, Mihail Dan

2018-01-01

Patients with hearing loss who underwent cochlear implantation can present symptomatic or asymptomatic vestibular damages earlier or later after the surgery. The vestibular permanent lesions could be acute, produced by surgical trauma or could be progressive due to local morphological changes made by the presence of the portelectrode in the inner ear (fibrosis related, ossification, basilar membrane distortion, endolymphatic hydrops). Besides histopathological findings in inner ear of cochlear implanted patients, the vestibular permanent damages could be found by assessment of clinical vestibular status. This study reports the sensorial vestibular functional findings for adults in cochlear implanted ears related to the electrode insertion type (cochleostomy or round window approach) and comparing to non-implanted deaf ears. A total of 20 adult patients with 32 cochlear implanted ears (12 patients with binaural cochlear implant and eight with monoaural) were selected for postoperatory vestibular examination by cervical and ocular vestibular myogenic potentials and vestibular caloric tests. The same tests were made for a control group of 22 non-implanted deaf ears. Functional testing results were reported related to the electrode insertion approach. For the cochleostomy group, we found different deficits: in 40% for saccular function, 44% for utricular function, and 12% horizontal canal dysfunction. In round window group, the deficit was present in 14.29% for saccular function, 28.57% for utricular function, and 28.58% for horizontal canal. In 46.88% of implanted ears, the vestibular function was completely preserved on all tested sensors. In conclusion, the vestibular functional status after inner ear surgery presents sensorial damages in 53.12% ears compare with the vestibular dysfunction existing in 50% of deaf non-operated ears. Round window insertion allows for better conservation of the vestibular function.

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.

Early Loading of Fluoridated Implants Placed in Fresh Extraction Sockets and Healed Bone: A 3- to 5-Year Clinical and Radiographic Follow-Up Study of 39 Consecutive Patients.

PubMed

Oxby, Gert; Oxby, Fredrik; Oxby, Johan; Saltvik, Tomas; Nilsson, Peter

2015-10-01

Immediate placement of implants in extraction sockets for early loading is an attractive treatment modality due to reduced treatment time. However, the outcome of fluoridated implants in this situation with regard to bone levels and health of soft tissues is not well documented. To evaluate the outcome of early loading of OsseoSpeed(™) dental implants placed into fresh extraction sockets and healed bone in consecutive patients treated in a private clinic. A total of 182 OsseoSpeed(™) implants (Astra Tech Implant System, DENTSPLY Implants, Mölndal, Sweden), 72 in immediate extraction sockets and 110 in healed sites, were placed in 39 consecutive patients. The implants were loaded with permanent restorations within 60 days (average 31 days). Clinical and radiographic follow-up examinations were performed annually for at least 3 years (mean 55 months). An aesthetic index was used to evaluate the soft tissues adjacent to the prosthetic restorations. No implant was lost during the observation period, giving a survival rate of 100%. Bone level changes during the observation period were minimal, with a mean marginal bone loss of 0.3 ± 0.9 mm around the delayed implants and a mean marginal bone gain of 0.3 ± 1.4 mm around the immediate implants (p = .0036). The frequency distribution of bone level revealed that 85% of implants placed in fresh extraction sockets and 84% of implants in healed bone did not show any loss of bone level during follow-up (p = NS). Soft tissue complications were observed at two immediate implant sites in one patient. The remaining 180 implants received the highest aesthetic score. Moreover, no signs of peri-implant purulent infection or aggressive bone loss were found during the follow-up period. Early loading of fluoridated implants with permanent constructions appears to be a viable therapy for implants placed immediately in extraction sites and in healed bone. © 2014 Wiley Periodicals, Inc.

Orthodontic management of congenitally missing maxillary lateral incisors: a case report.

PubMed

Paduano, Sergio; Cioffi, Iacopo; Rongo, Roberto; Cupo, Antonello; Bucci, Rosaria; Valletta, Rosa

2014-01-01

This case report describes the orthodontic treatment of a woman, aged 15 years, with permanent dentition, brachyfacial typology, with congenitally missing maxillary lateral incisors. Multibracket straightwire fixed appliance was used to open the space for dental implant placement, and treat the impaired occlusion. The missing lateral incisors were substituted with oral implants.

Permanent Pacemaker Implantation after TAVR – Predictors and Impact on Outcomes

PubMed Central

Sinning, Jan-Malte; Hammerstingl, Christoph; Werner, Nikos; Grube, Eberhard; Nickenig, Georg

2015-01-01

The number of patients undergoing transcatheter aortic valve replacement (TAVR) worldwide is increasing steadily. Atrioventricular conduction disturbances, with or without the need for permanent pacemaker (PPM) implantation, are one of the most common adverse events after TAVR. Among transcatheter heart valves (THV), rates of conduction abnormalities vary from less than 10 % to more than 50 %. Depending on the reported data referred to, historical data showed that up to one-third of the patients required implantation of a PPM following TAVR. Although generally considered as a minor complication, PPM may have a profound impact on prognosis and quality of life after TAVR. Current data support the hypothesis that conduction abnormalities leading to pacemaker dependency result from mechanical compression of the conduction system by the prosthesis stent frame and individual predisposing conduction defects such as right bundle-branch block (RBBB). With several large randomised trials and registry studies having been published recently and second generation THV having been introduced, the debate about predictors for pacemaker implantation and their impact on outcome after TAVR is still ongoing. PMID:29588683

Third-generation mobile phones (UMTS) do not interfere with permanent implanted pacemakers.

PubMed

Ismail, Mohamed M; Badreldin, Akmal M A; Heldwein, Matthias; Hekmat, Khosro

2010-07-01

Third-generation mobile phones, UMTS (Universal Mobile Telecommunication System), were recently introduced in Europe. The safety of these devices with regard to their interference with implanted pacemakers is as yet unknown and is the point of interest in this study. The study comprised 100 patients with permanent pacemaker implantation between November 2004 and June 2005. Two UMTS cellular phones (T-Mobile, Vodafone) were tested in the standby, dialing, and operating mode with 23 single-chamber and 77 dual-chamber pacemakers. Continuous surface electrocardiograms (ECGs), intracardiac electrograms, and marker channels were recorded when calls were made by a stationary phone to cellular phone. All pacemakers were tested under a "worst-case scenario," which includes a programming of the pacemaker to unipolar sensing and pacing modes and inducing of a maximum sensitivity setting during continuous pacing of the patient. Patients had pacemaker implantation between June 1990 and April 2005. The mean age was 68.4 +/- 15.1 years. Regardless of atrial and ventricular sensitivity settings, both UMTS mobile phones (Nokia 6650 and Motorola A835) did not show any interference with all tested pacemakers. In addition, both cellular phones did not interfere with the marker channels and the intracardiac ECGs of the pacemakers. Third-generation mobile phones are safe for patients with permanent pacemakers. This is due to the high-frequency band for this system (1,800-2,200 MHz) and the low power output between 0.01 W and 0.25 W.

Changes in pelvic organ prolapse mesh mechanical properties following implantation in rats.

PubMed

Ulrich, Daniela; Edwards, Sharon L; Alexander, David L J; Rosamilia, Anna; Werkmeister, Jerome A; Gargett, Caroline E; Letouzey, Vincent

2016-02-01

Pelvic organ prolapse (POP) is a multifactorial disease that manifests as the herniation of the pelvic organs into the vagina. Surgical methods for prolapse repair involve the use of a synthetic polypropylene mesh. The use of this mesh has led to significantly higher anatomical success rates compared with native tissue repairs, and therefore, despite recent warnings by the Food and Drug Administration regarding the use of vaginal mesh, the number of POP mesh surgeries has increased over the last few years. However, mesh implantation is associated with higher postsurgery complications, including pain and erosion, with higher consecutive rates of reoperation when placed vaginally. Little is known on how the mechanical properties of the implanted mesh itself change in vivo. It is assumed that the mechanical properties of these meshes remain unchanged, with any differences in mechanical properties of the formed mesh-tissue complex attributed to the attached tissue alone. It is likely that any changes in mesh mechanical properties that do occur in vivo will have an impact on the biomechanical properties of the formed mesh-tissue complex. The objective of the study was to assess changes in the multiaxial mechanical properties of synthetic clinical prolapse meshes implanted abdominally for up to 90 days, using a rat model. Another objective of the study was to assess the biomechanical properties of the formed mesh-tissue complex following implantation. Three nondegradable polypropylene clinical synthetic mesh types for prolapse repair (Gynemesh PS, Polyform Lite, and Restorelle) and a partially degradable polypropylene/polyglecaprone mesh (UltraPro) were mechanically assessed before and after implantation (n = 5/ mesh type) in Sprague Dawley rats for 30 (Gynemesh PS, Polyform Lite, and Restorelle) and 90 (UltraPro and Polyform Lite) days. Stiffness and permanent extension following cyclic loading, and breaking load, of the preimplanted mesh types, explanted mesh-tissue complexes, and explanted meshes were assessed using a multi-axial (ball-burst) method. The 4 clinical meshes varied from each other in weight, thickness, porosity, and pore size and showed significant differences in stiffness and breaking load before implantation. Following 30 days of implantation, the mechanical properties of some mesh types altered, with significant decreases in mesh stiffness and breaking load, and increased permanent extension. After 90 days these changes were more obvious, with significant decreases in stiffness and breaking load and increased permanent extension. Similar biomechanical properties of formed mesh-tissue complexes were observed for mesh types of different preimplant stiffness and structure after 90 days implantation. This is the first study to report on intrinsic changes in the mechanical properties of implanted meshes and how these changes have an impact on the estimated tissue contribution of the formed mesh-tissue complex. Decreased mesh stiffness, strength, and increased permanent extension following 90 days of implantation increase the biomechanical contribution of the attached tissue of the formed mesh-tissue complex more than previously thought. This needs to be considered when using meshes for prolapse repair. Crown Copyright © 2016. Published by Elsevier Inc. All rights reserved.

Transcatheter Heart Valve Selection and Permanent Pacemaker Implantation in Patients With Pre-Existent Right Bundle Branch Block.

PubMed

van Gils, Lennart; Tchetche, Didier; Lhermusier, Thibault; Abawi, Masieh; Dumonteil, Nicolas; Rodriguez Olivares, Ramón; Molina-Martin de Nicolas, Javier; Stella, Pieter R; Carrié, Didier; De Jaegere, Peter P; Van Mieghem, Nicolas M

2017-03-03

Right bundle branch block is an established predictor for new conduction disturbances and need for a permanent pacemaker (PPM) after transcatheter aortic valve replacement. The aim of the study was to evaluate the absolute rates of transcatheter aortic valve replacement related PPM implantations in patients with pre-existent right bundle branch block and categorize for different transcatheter heart valves. We pooled data on 306 transcatheter aortic valve replacement patients from 4 high-volume centers in Europe and selected those with right bundle branch block at baseline without a previously implanted PPM. Logistic regression was used to evaluate whether PPM rate differed among transcatheter heart valves after adjustment for confounders. Mean age was 83±7 years and 63% were male. Median Society of Thoracic Surgeons score was 6.3 (interquartile range, 4.1-10.2). The following transcatheter valve designs were used: Medtronic CoreValve (n=130; Medtronic, Minneapolis, MN); Edwards Sapien XT (ES-XT; n=124) and Edwards Sapien 3 (ES-3; n=32; Edwards Lifesciences, Irvine, CA); and Boston Scientific Lotus (n=20; Boston Scientific Corporation, Marlborough, MA). Overall permanent pacemaker implantation rate post-transcatheter aortic valve replacement was 41%, and per valve design: 75% with Lotus, 46% with CoreValve, 32% with ES-XT, and 34% with ES-3. The indication for PPM implantation was total atrioventricular block in 98% of the cases. Lotus was associated with a higher PPM rate than all other valves. PPM rate did not differ between ES-XT and ES-3. Ventricular paced rhythm at 30-day and 1-year follow-up was present in 81% at 89%, respectively. Right bundle branch block at baseline is associated with a high incidence of PPM implantation for all transcatheter heart valves. PPM rate was highest for Lotus and lowest for ES-XT and ES-3. Pacemaker dependency remained high during follow-up. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Current state of knowledge and experts' perspective on the subcutaneous implantable cardioverter-defibrillator.

PubMed

Santini, Massimo; Cappato, Riccardo; Andresen, Dietrich; Brachmann, Johannes; Davies, D Wyn; Cleland, John; Filippi, Alessandro; Gronda, Edoardo; Hauer, Richard; Steinbeck, Gerhard; Steinhaus, David

2009-06-01

ICD implantation is today a well-recognized therapy to prevent sudden cardiac death. The available implantable devices at present need the use of permanent endocavitary leads which may cause, in some instances, serious troubles to the patients (lead dislodgement, ventricular perforation, lead infections, etc.). A new implantable defibrillator provided by only a subcutaneous lead is at present under evaluation. Its potential indications, usefulness benefits, and problems represent an interesting field of investigation and discussion. This paper describes the conclusions recently reached by a panel of experts, with regard to the potential role of an implantable subcutaneous defibrillator in the prevention of sudden cardiac death.

Maxillary tridimensional changes after slow expansion with leaf expander in a sample of growing patients: a pilot study.

PubMed

Lanteri, V; Gianolio, A; Gualandi, G; Beretta, M

2018-03-01

The aim of this study is to evaluate the dento-alveolar effects of slow maxillary expansion using the Leaf Expander in a sample of growing patients with maxillary transverse deficiency, unilateral cross bite and mandibular shift. The study included 10 patients, 3 male and 7 female (mean age 7.5 + 7 months), treated with Leaf Expander anchored on the upper deciduous teeth. Digital models were obtained by a lab scan of the pvs impressions at the beginning of the therapy (T1) and at the removal of the palatal expander (T2). Five parameters were measured: 1) the distance between the first upper permanent molars; 2) the distance between the upper second deciduous molars; 3) the distance between the upper canine cusps 4) the distance between the first lower permanent molars; 5) the distance of the lower canine cusps. In all patients complete correction of posterior crossbite was achieved on average in 4 months, with a spontaneous expansion of the upper first permanent molars. Significant increases in the dento-alveolar transversal diameters were obtained. Increases were also observed in the anterior mandibular arch diameter (+ 1 mm). These findings suggest that slow maxillary expansion using Leaf Expander appliance could be a reasonable alternative to conventional maxillary expansion therapy in the early mixed dentition.

Preliminary assessment of a hysteroscopic fallopian tube heat and biomaterial technology for permanent female sterilization

NASA Astrophysics Data System (ADS)

Divakar, Prajan; Trembly, B. Stuart; Moodie, Karen L.; Hoopes, P. Jack; Wegst, Ulrike G. K.

2017-02-01

Recent failures in hysteroscopic female sterilization procedures have brought into question the implantation of nonresorbable metal devices into the fallopian tubes due to long-term risks such as migration, fragmentation, and tubal perforation. The goal of this study is to assess whether a porous, biodegradable implant can be deposited into the fallopian tube lumen with or without a local mild heat treatment to generate a safe and permanent fallopian tube occlusion/sterilization event. The technologies investigated included freeze-cast collagen-based scaffolds and magnetic nanoparticle (MNP) based scaffolds. In vitro assessment of iron oxide MNP-based scaffolds was performed to determine the absorption rate density (ARD); subsequent computational modeling quantified the thermal in vivo steady state temperature as a function of tubal radius for treatment planning. For collagen-based scaffolds, in vivo testing was performed to study the biocompatibility in a mouse flank model, followed by implantation into an in vivo anestrus feline uterine horn (animal model for the fallopian tube). Biological responses were studied histopathologically. Uterine horn patency was assessed via radiographic imaging. Preliminary studies suggest the MNP-impregnated scaffold and a safe, noninvasive AMF excitation field have potential to generate a sufficient focal fallopian tube thermal dose to create a fibrotic healing event and ultimately, permanent tubal occlusion.

Orthodontic Management of Congenitally Missing Maxillary Lateral Incisors: A Case Report

PubMed Central

Rongo, Roberto; Cupo, Antonello; Valletta, Rosa

2014-01-01

This case report describes the orthodontic treatment of a woman, aged 15 years, with permanent dentition, brachyfacial typology, with congenitally missing maxillary lateral incisors. Multibracket straightwire fixed appliance was used to open the space for dental implant placement, and treat the impaired occlusion. The missing lateral incisors were substituted with oral implants. PMID:24711929

Stress distribution and displacement by different bone-borne palatal expanders with micro-implants: a three-dimensional finite-element analysis.

PubMed

Lee, Hye Kyung; Bayome, Mohamed; Ahn, Chee Soo; Kim, Seong-Hun; Kim, Ki Beom; Mo, Sung-Seo; Kook, Yoon-Ah

2014-10-01

The aim of this study was to analyze stress distribution and displacement of the maxilla and teeth according to different designs of bone-borne palatal expanders using micro-implants. A three-dimensional (3D) finite-element (FE) model of the craniofacial bones and maxillary teeth was obtained. Four designs of rapid maxillary expanders: one with micro-implants placed lateral to mid-palatal suture (type 1), the second at the palatal slope (type 2), the third as in type 1 with additional conventional Hyrax arms (type 3), and the fourth surgically assisted tooth-borne expander (type 4) were added to the FE models. Expanders were activated transversely for 0.25mm. Geometric nonlinear theory was applied to evaluate Von-Mises Stress distribution and displacement. All types exhibited downward displacement and demonstrated more horizontal movement in the posterior area. Type 3 showed the most transverse displacement. The rotational movement of dentoalveolar unit was larger in types 1 and 3, whereas it was relatively parallel in types 2 and 4. The stresses were concentrated around the micro-implants in types 1 and 3 only. Type 2 had the least stress concentrations around the anchorage and showed alveolar expansion without buccal inclination. It is recommended to apply temporary anchorage devices to the palatal slopes to support expanders for efficient treatment of maxillary transverse deficiency. © The Author 2012. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.

The cost effectiveness of acellular dermal matrix in expander-implant immediate breast reconstruction.

PubMed

Krishnan, Naveen M; Chatterjee, Abhishek; Rosenkranz, Kari M; Powell, Stephen G; Nigriny, John F; Vidal, Dale C

2014-04-01

Expander-implant breast reconstruction is often supplemented with acellular dermal matrix (ADM). The use of acellular dermal matrix has allowed for faster, less painful expansions and improved aesthetics, but with increased cost. Our goal was to provide the first cost utility analysis of using acellular dermal matrix in two-stage, expander-implant immediate breast reconstruction following mastectomy. A comprehensive literature review was conducted to identify complication rates for two-stage, expander-implant immediate breast reconstruction with and without acellular dermal matrix. The probabilities of the most common complications were combined with Medicare Current Procedural Terminology reimbursement codes and expert utility estimates to fit into a decision model. The decision model evaluated the cost effectiveness of acellular dermal matrix relative to reconstructions without it. Retail costs for ADM were derived from the LifeCell 2012 company catalogue for Alloderm. The overall complication rates were 30% and 34.5% with and without ADM. The decision model revealed a baseline cost increase of $361.96 when acellular dermal matrix is used. The increase in Quality-Adjusted Life Years (QALYs) is 1.37 in the population with acellular dermal matrix. This yields a cost effective incremental cost-utility ratio (ICUR) of $264.20/QALY. Univariate sensitivity analysis confirmed that using acellular dermal matrix is cost effective even when using retail costs for unilateral and bilateral reconstructions. Our study shows that, despite an increased cost, acellular dermal matrix is a cost effective technology for patients undergoing two-stage, expander-implant immediate breast reconstruction due to its increased utility in successful procedures. Crown Copyright © 2013. Published by Elsevier Ltd. All rights reserved.

Fast GPU-based Monte Carlo simulations for LDR prostate brachytherapy.

PubMed

Bonenfant, Éric; Magnoux, Vincent; Hissoiny, Sami; Ozell, Benoît; Beaulieu, Luc; Després, Philippe

2015-07-07

The aim of this study was to evaluate the potential of bGPUMCD, a Monte Carlo algorithm executed on Graphics Processing Units (GPUs), for fast dose calculations in permanent prostate implant dosimetry. It also aimed to validate a low dose rate brachytherapy source in terms of TG-43 metrics and to use this source to compute dose distributions for permanent prostate implant in very short times. The physics of bGPUMCD was reviewed and extended to include Rayleigh scattering and fluorescence from photoelectric interactions for all materials involved. The radial and anisotropy functions were obtained for the Nucletron SelectSeed in TG-43 conditions. These functions were compared to those found in the MD Anderson Imaging and Radiation Oncology Core brachytherapy source registry which are considered the TG-43 reference values. After appropriate calibration of the source, permanent prostate implant dose distributions were calculated for four patients and compared to an already validated Geant4 algorithm. The radial function calculated from bGPUMCD showed excellent agreement (differences within 1.3%) with TG-43 accepted values. The anisotropy functions at r = 1 cm and r = 4 cm were within 2% of TG-43 values for angles over 17.5°. For permanent prostate implants, Monte Carlo-based dose distributions with a statistical uncertainty of 1% or less for the target volume were obtained in 30 s or less for 1 × 1 × 1 mm(3) calculation grids. Dosimetric indices were very similar (within 2.7%) to those obtained with a validated, independent Monte Carlo code (Geant4) performing the calculations for the same cases in a much longer time (tens of minutes to more than a hour). bGPUMCD is a promising code that lets envision the use of Monte Carlo techniques in a clinical environment, with sub-minute execution times on a standard workstation. Future work will explore the use of this code with an inverse planning method to provide a complete Monte Carlo-based planning solution.

Fast GPU-based Monte Carlo simulations for LDR prostate brachytherapy

NASA Astrophysics Data System (ADS)

Bonenfant, Éric; Magnoux, Vincent; Hissoiny, Sami; Ozell, Benoît; Beaulieu, Luc; Després, Philippe

2015-07-01

The aim of this study was to evaluate the potential of bGPUMCD, a Monte Carlo algorithm executed on Graphics Processing Units (GPUs), for fast dose calculations in permanent prostate implant dosimetry. It also aimed to validate a low dose rate brachytherapy source in terms of TG-43 metrics and to use this source to compute dose distributions for permanent prostate implant in very short times. The physics of bGPUMCD was reviewed and extended to include Rayleigh scattering and fluorescence from photoelectric interactions for all materials involved. The radial and anisotropy functions were obtained for the Nucletron SelectSeed in TG-43 conditions. These functions were compared to those found in the MD Anderson Imaging and Radiation Oncology Core brachytherapy source registry which are considered the TG-43 reference values. After appropriate calibration of the source, permanent prostate implant dose distributions were calculated for four patients and compared to an already validated Geant4 algorithm. The radial function calculated from bGPUMCD showed excellent agreement (differences within 1.3%) with TG-43 accepted values. The anisotropy functions at r = 1 cm and r = 4 cm were within 2% of TG-43 values for angles over 17.5°. For permanent prostate implants, Monte Carlo-based dose distributions with a statistical uncertainty of 1% or less for the target volume were obtained in 30 s or less for 1 × 1 × 1 mm3 calculation grids. Dosimetric indices were very similar (within 2.7%) to those obtained with a validated, independent Monte Carlo code (Geant4) performing the calculations for the same cases in a much longer time (tens of minutes to more than a hour). bGPUMCD is a promising code that lets envision the use of Monte Carlo techniques in a clinical environment, with sub-minute execution times on a standard workstation. Future work will explore the use of this code with an inverse planning method to provide a complete Monte Carlo-based planning solution.

Improved extraction of ePTFE and medical adhesive modified defibrillation leads from the coronary sinus and great cardiac vein.

PubMed

Wilkoff, Bruce L; Belott, Peter H; Love, Charles J; Scheiner, Avram; Westlund, Randy; Rippy, Marian; Krishnan, Mohan; Norlander, Barry E; Steinhaus, Bruce; Emmanuel, Janson; Zeller, Peter J

2005-03-01

Permanent leads with shocking coils for defibrillation therapy are sometimes implanted in the coronary sinus (CS) and great cardiac vein (GCV). These shocking coils, as documented by pathologic examination of animal investigations, often become tightly encapsulated by fibrosis and can be very difficult to remove. One of three configurations of the Guidant model 7109 Perimeter coronary sinus shocking lead was implanted into the distal portion of the GCV of 24 sheep for up to 14 months. Group 1 had unmodified coils (control), group 2 had coils backfilled with medical adhesive (MA), and Group 3 had coils coated with expanded polytetrafluoroethylene (ePTFE). Eighteen leads, three from each group at 6 and 14 months were transvenously extracted from the left jugular vein. The remaining six animals were not subject to extraction. All animals were euthanized for pathological and microscopic examination. All six of the control, three of the MA, and one of the ePTFE leads required the use of an electrosurgical dissection sheath (EDS) for extraction. Five control, two MA, and none of the ePTFE leads had significant fibrotic attachments to the shocking coils. Significant trauma was observed at necropsy for those leads requiring the use of the EDS for extraction. Tissue ingrowth is a major impediment to the removal of defibrillation leads implanted in the CS and GCV of sheep. Reduction of tissue ingrowth by coating the shocking coils with ePTFE or by backfilling with MA facilitates transvenous lead removal with reduced tissue trauma.

Midterm to long-term safety and efficacy of self-expandable nitinol stent implantation for coarctation of aorta in adults.

PubMed

Haji Zeinali, Ali Mohammad; Sadeghian, Mohammad; Qureshi, Shakeel A; Ghazi, Payam

2017-09-01

Endovascular treatment of coarctation of aorta (CoA) by self-expandable Nitinol stents is one of the recognized treatment methods and may be an alternative to surgery or balloon-expandable stent implantation for CoA but there is little information about midterm to long term results of self-expandable stents. Sixty-two patients with CoA (40 men), with a mean age of 30.7 ± 11 years, (range 17-63 years) underwent stent implantation with Optimed self-expandable Nitinol stents between 2005 and 2014. Successful outcome was defined as peak systolic pressure gradient ≤20 mmHg after stent implantation. The patients were followed-up clinically and by echocardiography and in patients, in whom there was suspicion of recoarctation, CT angiography or recatheterization was performed. 65 stents were successfully implanted in all 62 patients. Peak systolic pressure gradient decreased from mean 62.4 ± 18 mmHg (range 35-100 mmHg) to mean 2.8 ± 5 mmHg (range 0-15 mmHg; P < 0.001). Stent displacement occurred in 3 patients during the procedure. These were managed successfully by an overlapping second stent. None of the patients had major complications such as aortic dissection, rupture, or vascular access problems. In follow up, only three patients had recoarctation, and two of these were managed successfully by balloon redilation or further stenting 16 and 18 months after the first procedure and one patient refused reintervention. There were two deaths, unrelated to the procedure, 12 and 78 months after the initial intervention. Follow-up of a mean of 45.5 ± 17 months (range 12-105 months) demonstrated no evidence of aneurysm formation or stent fracture. Self-expandable nitinol stents for the treatment of native and recurrent CoA is safe and has good efficacy with acceptable midterm to long-term outcome. © 2017 Wiley Periodicals, Inc.

Orbital volume augmentation using expandable hydrogel implants in acquired anophthalmia and phthisis bulbi.

PubMed

Kim, Esther Lee; Bernardino, Carlo Rob; Levin, Flora

2016-01-01

The purpose of this study is to describe our experience using expandable spherical hydrogel implants and injectable hydrogel pellets for orbital volume augmentation in cases of post-enucleation socket syndrome after acquired anophthalmia or phthisis bulbi. We retrospectively reviewed the clinical records of all adult patients who received an expandable hydrogel implant for orbital volume loss following enucleation or phthisis bulbi at the Emory Eye Center between 2004 and January 2007 and the Yale Eye Center between 2009 and 2011. The study included 9 women and 5 men with a mean age of 51.2 years old (range 35-76 years old). Follow-up spanned 6 to 71 months (median of 18.5 months). Four patients received spherical hydrogel implants and 10 patients received hydrogel pellet injections. On average, nine pellets (range 5-16) were placed in each patient over an average of 1.7 injections (range 1-3). Most commonly, five pellets were injected per session, as was the case for 13 of the 17 treatment sessions. Post-operative complications included 2 cases of pellet migration, one subcutaneously and one anteriorly due to insufficiently posterior implant placement, and 1 hospital admission for pain after injection of 10 pellets in one visit. All patients experienced an overall subjective improvement in cosmesis. Self-expandable hydrogel implants appear to offer several advantages over other existing options for orbital volume augmentation, as they are easy to place, generally well-tolerated, volume-titratable, and to the extent that our follow-up shows, may be a safe and durable means of treating orbital volume loss in patients with acquired anophthalmia and phthisis bulbi.

14 CFR 67.211 - Cardiovascular.

Code of Federal Regulations, 2011 CFR

2011-01-01

... any of the following: (a) Myocardial infarction; (b) Angina pectoris; (c) Coronary heart disease that...) Cardiac valve replacement; (e) Permanent cardiac pacemaker implantation; or (f) Heart replacement. ...

14 CFR 67.211 - Cardiovascular.

Code of Federal Regulations, 2014 CFR

2014-01-01

... any of the following: (a) Myocardial infarction; (b) Angina pectoris; (c) Coronary heart disease that...) Cardiac valve replacement; (e) Permanent cardiac pacemaker implantation; or (f) Heart replacement. ...

14 CFR 67.211 - Cardiovascular.

Code of Federal Regulations, 2012 CFR

2012-01-01

... any of the following: (a) Myocardial infarction; (b) Angina pectoris; (c) Coronary heart disease that...) Cardiac valve replacement; (e) Permanent cardiac pacemaker implantation; or (f) Heart replacement. ...

14 CFR 67.211 - Cardiovascular.

Code of Federal Regulations, 2013 CFR

2013-01-01

... any of the following: (a) Myocardial infarction; (b) Angina pectoris; (c) Coronary heart disease that...) Cardiac valve replacement; (e) Permanent cardiac pacemaker implantation; or (f) Heart replacement. ...

[Sacral nerve stimulation in fecal incontinence].

PubMed

Rasmussen, Ole Ø; Christiansen, John

2002-08-12

Sacral nerve stimulation for the treatment of faecal incontinence has gained increasing use in Europe over the last two years. Experience with the first patients treated in Denmark is described here. Fourteen patients with severe faecal incontinence were given sacral nerve stimulation. The first treatment was temporary, and if this was successful they had a device for permanent stimulation implanted. The result of the test stimulation was good in ten of the 14 patients and a permanent system was implanted. After a median of 4.5 months' stimulation, nine of the ten patients continued to respond to respond well. Sacral nerve stimulation in the treatment of faecal incontinence shows promising results. Compared to other more advanced forms of treatment, this method is minimally invasive.

Cochlear implant surgery in patients more than seventy-nine years old.

PubMed

Eshraghi, Adrien A; Rodriguez, Michael; Balkany, Thomas J; Telischi, Fred F; Angeli, Simon; Hodges, Annelle V; Adil, Eelam

2009-06-01

To evaluate the surgical complications, auditory performance, and hearing handicap following cochlear implantation in patients greater than 79 years of age. Retrospective trial, tertiary referral center. The study group was comprised of 21 patients implanted after 79 years of age from 1996 through 2006 with follow-ups past their 8th decade. Pre-op evaluation consisted of pure-tone audiometry and speech discrimination scores (Hearing in Noise Test and City University of New York sentence test). The results of these tests were compared to similar tests taken post-op. A validated hearing handicap questionnaire was used to evaluate the outcome. There were no permanent medical or surgical complications. However, two patients developed exacerbations of previous comorbid conditions (i.e., urinary retention and acute delirium). Implanted patients experienced a significant improvement in audiologic performance, post-op pure tone average, and post-op speech scores (P < .001). A majority of them were able to use the phone and reported that the cochlear implant was of great benefit to them. The post-op hearing handicap inventory for the elderly demonstrated a significant decrease of hearing handicap scores. This is the first study to focus on a patient group this advanced in age. With increasing life expectancy, we should begin to stratify risk versus benefit of cochlear implantation in this age group. Cochlear implantation improved audiologic performance and the quality of life in patients older than 79 years old. There were no permanent medical or surgical complications. Chronic pain and temporary vertigo were the most common complications reported in this elderly group. Laryngoscope, 2009.

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.

Anatomical approach to permanent His bundle pacing: Optimizing His bundle capture.

PubMed

Vijayaraman, Pugazhendhi; Dandamudi, Gopi

2016-01-01

Permanent His bundle pacing is a physiological alternative to right ventricular pacing. In this article we describe our approach to His bundle pacing in patients with AV nodal and intra-Hisian conduction disease. It is essential for the implanters to understand the anatomic variations of the His bundle course and its effect on the type of His bundle pacing achieved. We describe several case examples to illustrate our anatomical approach to permanent His bundle pacing in this article. Copyright © 2016 Elsevier Inc. All rights reserved.

Tissue Expander versus Tissue Expander and Latissimus Flap in Morbidly Obese Breast Reconstruction Patients

PubMed Central

Adams, Robert L.; Chandler, Robert G.; Parks, Joseph

2015-01-01

Background: Immediate postmastectomy breast reconstruction in morbidly obese patients represents a challenge because neither prosthetic nor abdominal-based options may be suitable. Methods: This study compared a previously published cohort of immediate prosthetic reconstruction of 346 patients (511 breasts) of whom 49 patients (67 breasts) were morbidly obese (defined as a body mass index > 35) with a morbidly obese patient population whose breasts were reconstructed immediately following postmastectomy with latissimus flap and tissue expander (21 patients and 22 breasts) in the same time period. The preoperative risk factors of mastectomy such as tobacco use, diabetes, and prior radiation and the postoperative complications of mastectomy such as skin necrosis, seroma, and prosthesis loss were examined. The explantation of the tissue expander provided a defined endpoint of reconstruction failure. Results: The average body mass index in the tissue expander/implant group and in the latissimus flap plus tissue expander/implant group was 40.9 and 40.1, respectively. The risk profile of diabetes and tobacco use was similar in both groups. Fifteen of the 67 breasts (22.3%) of the tissue expander/implant group and 15 of the 23 breasts (65.2%) of the latissimus flap group had received prior radiation. The prosthesis loss was 13 of 67 breasts (19.4%) that had tissue-expander–alone reconstruction and 1 of 22 (4.8%) in the latissimus group that had tissue expander reconstruction. Modification of donor-site incision and skin-island location in the latissimus group of patients can minimize scar deformity. Conclusion: The loss rate in immediate postmastectomy reconstruction in morbidly obese patients with latissimus flap plus tissue expander was substantially lower than the loss rate in those with breast reconstructed with tissue expander alone. PMID:25878934

Treatment of Symptomatic Severe Aortic Stenosis With a Novel Resheathable Supra-Annular Self-Expanding Transcatheter Aortic Valve System.

PubMed

Manoharan, Ganesh; Walton, Antony S; Brecker, Stephen J; Pasupati, Sanjeevan; Blackman, Daniel J; Qiao, Hongyan; Meredith, Ian T

2015-08-24

The purpose of this study was to prospectively evaluate the safety and clinical performance of the CoreValve Evolut R transcatheter aortic valve replacement (TAVR) system (Medtronic, Inc., Minneapolis, Minnesota) in a single-arm, multicenter pivotal study in high- or extreme-risk patients with symptomatic aortic valve stenosis. Although outcomes following TAVR are improving, challenges still exist. The repositionable 14-F equivalent CoreValve Evolut R TAVR system was developed to mitigate some of these challenges. Suitable patients (n = 60) underwent TAVR with a 26- or 29-mm Evolut R valve. Primary safety endpoints were mortality and stroke at 30 days. Primary clinical performance endpoints were device success per the VARC-2 (Valve Academic Research Consortium-2) and the percent of patients with mild or less aortic regurgitation 24 h to 7 days post-procedure. Patients (66.7% female; mean age 82.8 ± 6.1 years; Society of Thoracic Surgeons Score 7.0 ± 3.7%) underwent TAVR via the transfemoral route in 98.3%, using a 29-mm valve in 68.3% of patients. All attempts at repositioning were successful. No death or stroke was observed up to 30 days. The VARC-2 overall device success rate was 78.6%. Paravalvular regurgitation post TAVR was mild or less in 96.6%, moderate in 3.4%, and severe in 0% at 30 days. Major vascular complications occurred in 8.3%, and permanent pacemaker implantation was required in 11.7% of patients. The repositionable 14-F equivalent Evolut R TAVR system is safe and effective at treating high-risk symptomatic aortic stenosis patients. Repositioning was successful when required in all patients, with low rates of moderate or severe paravalvular aortic regurgitation and low permanent pacemaker implantation. (The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study; NCT01876420). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Clinical Considerations of Adapted Drilling Protocol by Bone Quality Perception.

PubMed

Toia, Marco; Stocchero, Michele; Cecchinato, Francesca; Corrà, Enrico; Jimbo, Ryo; Cecchinato, Denis

To evaluate insertion torque value (ITV) and marginal bone loss (MBL) of an implant system after a clinically perceived bone quality-adapted drilling. This multicenter retrospective study included patients treated with implants, conventionally loaded, in completely healed sites. Operators customized the osteotomy preparation according to radiographic assessment and their perception of bone quality. Drilling sequence, bone quality, and ITV were recorded at the time of surgery. Radiographs were taken at the time of implant placement and permanent restoration. MBL between implant placement and permanent restoration was calculated. The implant was used as the statistical unit. Demographic and implant characteristics were shown by means of descriptive statistics. Outcome values were compared using analysis of variance (ANOVA) and Kruskal-Wallis tests. Multiple regression models were used to test the effect of independent variables on ITV and MBL. One hundred eighty-eight implants placed in 87 patients were included in the analysis. The mean observation period was 144 ± 59 days. The mean ITV was 30.8 ± 15.1 Ncm. ITV differed significantly based on arches (mandible/maxilla) (P = .001), bone quality (P < .001), implant diameter (P = .032), and drilling protocol (P = .019). Median MBL was 0.05 mm (0.00; 0.24). A significant difference was found between the mandible and maxilla (P = .008) and between drilling protocols (P = .011). In particular, significantly higher MBL was found in the undersized drilling protocol. Multiple regression analysis showed that ITV was influenced by bone quality and implant diameter. MBL was influenced by bone quality, implant diameter, ITV, and the interaction between bone quality and ITV. It was estimated that MBL was greater with increased bone density and ITV. Excessive ITV in dense bone can cause negative marginal bone responses. A presurgical radiographic assessment and the perception of bone quality are necessary to select an optimal drilling protocol and to minimize surgical trauma.

Percutaneous tricuspid valvotomy for pacemaker lead-induced tricuspid stenosis

PubMed Central

Patil, Devendra V.; Nabar, Ashish A.; Sabnis, Girish R.; Phadke, Milind S.; Lanjewar, Charan P.; Kerkar, Prafulla G.

2015-01-01

Permanent pacemaker lead-induced tricuspid regurgitation is extremely uncommon. We report a patient with severe tricuspid stenosis detected 10 years after permanent single chamber pacemaker implantation in surgically corrected congenital heart disease. The loop at the level of the tricuspid valve may have caused endothelial injury and eventually led to stenosis. Percutaneous balloon valvotomy for such stenosis has not been reported from India. PMID:26995417

[Permanent cardiac pacing for chronic symptomatic atrioventricular block in uremic hemodialysed patients. A prospective study].

PubMed

Arsenescu, Cătălina; Georgescu, G I M; Covic, A; Briotă, Laura

2002-01-01

Though sudden cardiac death accounts for as much as 15% of all cause mortality in uremia, reports concerning advanced A-V block, requiring permanent cardiac pacing in end-stage renal disease (ESRD) hemodialysed (HD) patients are very few. This is the first long term prospective study reporting on systematic permanent pacemaker implantation, in a cohort of ESRD patients from a single HD unit. Between 01/06/1997 and 30/12/2001, 396 pacemakers were inserted for advanced, symptomatic A-V block in our institution, including 5 in ESRD, HD patients (M/F--4/1, age 47-73, M +/- SD--61 +/- 12 years) from a single dialysis center, treating 137 patients during the study period. Thus, the incidence and prevalence of A-V defects treated by permanent pacing in uremic patients was 0.81% and 3.65% respectively. Conversely, the incidence and prevalence of ESRD treated by hemodialysis, among patients with advanced A-V conduction disturbances, requiring permanent pacing were 0.28% and 1.26%. Mitral valve calcifications were present in all patients; 3 subjects also had extensive aortic valve calcifications. Left ventricular hypertrophy (echocardiographic Framingham criteria) was present in 4 patients, but the systolic function (ejection fraction and fractional shortening index) was normal in all cases, although a clinical picture of chronic heart failure was seen in 3 subjects preoperatively. A-V conduction defects were attributed to extensive metastatic calcifications, involving the cardiac squeleton, consecutive to severe hyperparathyroidism and inadvertent use of calcitriol and calcium carbonate as phosphate binders. No technical difficulties, short or long-term complications related to pacemaker implantation (4 VVI and 1 VVD devices) were encountered. Acute threshold and sensing values were similar with those of non-uremic patients. During follow-up, one patients died from a non cardiac death. If optimal hemodialysis is provided, benefits of permanent pacing are equal in uremic or non uremic patients and pacemaker implantation should be instituted as a prompt life-saving method in all dialysis patients with chronic symptomatic advanced A-V blocks.

Clinical Profile and Early Complications after Single and Dual Chamber Permanent Pacemaker Implantation at Manmohan Cardiothoracic Vascular and Transplant Centre, Kathmandu, Nepal.

PubMed

Khanal, J; Poudyal, R R; Devkota, S; Thapa, S; Dhungana, R R

2015-01-01

Permanent pacemaker implantation is a minimally invasive surgical procedure in the management of patients with cardiac problems. However, complications during and after implantation are not uncommon. There is lack of evidences in rate of complications with the selection of pacemakers in Nepal. Therefore, this study was performed to compare the frequency of implantation and complication rate between single chamber and dual chamber pacemaker. The present study is based on all consecutive pacemaker implantations in a single centre between April 2014 and May 2015. A total of 116 patients were categorized into two cohorts according to the type of pacemaker implanted- single chamber or dual chamber. All patients had regular 2-weeks follow-up intervals with standardized documentation of all relevant patient data till 6-week after implantation. Data were presented as means ± standard deviation (SD) for continuous variables and as proportions for categorical variables. Comparison of continuous variables between the groups was made with independent Student's t-test. For discrete variables distribution between groups were compared with Chi-square test. The mean age (±SD) of total population at implant was 64.08 (± 15.09) years. Dual chamber units were implanted in 44 (37.93%) of patients, single chamber in 72 (62.06%). Only 14 women (31.81%) received dual chamber compared with 42 women (58.33%) who received single chamber (Chi-square=18, DF=1, P = 0.0084). Complete atrioventricular block was the commonest (56.03%) indication for permanent pacemaker insertion followed by sick sinus syndrome (33.62%), symptomatic high-grade AV block (11.20%). Hypertension (dual chamber 21.55%, single chamber 40.51%) was the most common comorbidity in both cohorts. Complications occurred in 11 (9.48%) patients. More proportion of complication occurred in single chamber group (9 patients, 12.50%) than in dual chamber (2 patients, 4.54%). Complications occurring in dual chamber group include pocket hematoma 1 patient (2.27%) and arrhythmia in 1 patient (2.27%). Similarly, complications occurring in single chamber include RV perforation in two patients (2.77%) and one each (1.38%) had pocket hematoma, pneumothorax, infection, swelling at pocket site, arrhythmia in the form of NSVT, leads displacement, DVT and mortality. Women were more likely to receive single chamber systems than men. More proportion of complication occurred in single chamber group than in dual chamber. Future prospective studies on larger number of patients are needed to confirm and support our findings.

In the Age of Breast Augmentation, Breast Reconstruction Provides an Opportunity to Augment the Breast.

PubMed

Zimmerman, Amanda L; Tugertimur, Bugra; Smith, Paul D; Kumar, Ambuj; Dayicioglu, Deniz

2017-01-01

Augmentation mammoplasty remains the most common cosmetic surgery procedure performed. The objective of this article is to evaluate the impact of augmented volume of the reconstructed breast in patients that undergo nipple-sparing mastectomy and patients previously augmented who undergo mastectomy with tissue expander/implant-based reconstruction. Patients undergoing skin-sparing mastectomy, nipple-sparing mastectomy, and mastectomy after previous augmentation followed by tissue expander/implant-based reconstruction between June 2011 and April 2015 by 2 surgeons at the same institution were included. Retrospective chart review of the patients identified using these criteria was performed to record patient characteristics, complications, breast volume, implant volume, and percentage change in volume at the time of reconstruction. Percentage change of breast volume was calculated using the formula (implant breast weight)/(breast weight) for skin-sparing and nipple-sparing mastectomy patients and (final breast implant weight - [breast weight + augmentation breast implant weight])/([breast weight + augmentation breast implant]) for patients undergoing mastectomy following previous augmentation. A total of 293 patients were included in the study with 63 patients who underwent nipple-sparing mastectomy, 166 patients who underwent skin-sparing mastectomy, and 64 patients who underwent previous augmentation with subsequent mastectomy. Mean percentage change in breast volume was 66% in the nipple-sparing mastectomy group, 15% for the right breast and 18% for the left breast in the skin-sparing mastectomy group, and 81% for the right breast and 72% for the left breast in the mastectomy following previous augmentation group. Complication rate for nipple-sparing mastectomy was 27%, mastectomy following previous augmentation was 20.3%, and skin-sparing mastectomy group was 18.7%. Patients who undergo nipple-sparing mastectomy or mastectomy following previous augmentation have the ability to achieve greater volume in their reconstructed breast via tissue expander/implant-based reconstruction.

Immediate provisional restoration of a single-tooth implant in the esthetic zone: a case report.

PubMed

Fu, Po-Sung; Wu, Yi-Min; Tsai, Ching-Fang; Huang, Ta-Ko; Chen, Wen-Cheng; Hung, Chun-Cheng

2011-02-01

Immediate implant restoration of single implants may demonstrate a positive effect on peri-implant soft tissue. Placement of a provisional restoration following implant surgery can create soft tissue contours that resemble normal gingival topography before placement of the definitive prosthesis. This article describes a staged approach of the mandibular permanent right central incisor, which was congenital missing. The proper space for restoration of the missing incisor was created through orthodontic treatment. The scheduled implant site was reconstructed using autogenous bone harvested from the chin region. After a healing period of four months, an implant was installed with the connection of a fixed provisional crown to a prefabricated temporary abutment. The soft tissue around the implant healed according to the contours of the provisional restoration and the emergence profile was used to duplicate the definitive restoration. Peri-implant esthetics was achieved through the staged approach and immediate restoration of the implant. Copyright © 2011. Published by Elsevier B.V.

Trans-apical aortic valve implantation using a new self-expandable bioprosthesis: initial outcomes.

PubMed

Kempfert, Jörg; Rastan, Ardawan J; Beyersdorf, Friedhelm; Schönburg, Markus; Schuler, Gerhard; Sorg, Stefan; Mohr, Friedrich-W; Walther, Thomas

2011-11-01

Trans-apical aortic valve implantation (TA-AVI) has evolved into a standard approach for high-risk, elderly patients using the balloon-expandable Edwards SAPIEN™ prosthesis. As an alternative device, a self-expanding sub-coronary trans-apical bioprosthesis was evaluated. The Symetis Acurate™ trans-catheter heart valve is composed of a porcine biologic valve attached to a self-expandable nitinol stent. It allows for anatomical orientation, and facilitates intuitive implantation providing tactile feedback. Three valves sizes were available to treat patients with an annular diameter between 21 and 27mm. Since November 2009, a total of 40 patients have been treated at three sites. Patient age was 82.8±4 years, 60% were female, logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 21.5±10.9% and Society of Thoracic Surgeons (STS) Score was 9.0±4.6%. All implants were delivered successfully in the intra-annular and sub-coronary position off pump. One patient was converted to conventional surgery due to coronary impingement; post-dilatation was performed in 45% of patients; and two patients required the SAPIEN™ valve in valve implantation. Echocardiographic and angiographic control revealed no/trivial aortic incompetence (AI) in 59%, mild AI in 33.3%, and moderate AI in 7.7% of the patients. Three patients died within 30 days from a non-valve-related cause (respiratory), the patient converted did not recover from right-heart failure, and one patient died on day 19 due to unclear reasons. There was one incidence of new-onset atrioventricular (AV) block requiring pacemaker implantation. Two patients suffered a stroke (one secondary and the other intraprocedural). Transvalvular gradients were maximum 29.4±10.7mmHg and mean 14.3±6.8mmHg. The initial clinical results indicate a relatively straightforward implantation procedure and good functional results after trans-apical implantation of the Symetis Acurate™ device. Copyright © 2011 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

Optimizing Stimulation in a Case of Facial Pain Through "Cross-Talk" of Peripheral and Central Leads: A Case Report.

PubMed

McRoberts, W Porter

2016-12-01

To describe inter-lead (cross-talk) stimulation between a trigeminal nerve lead and a cervical epidural lead for the treatment of facial pain in a 69-year-old patient with empty nose syndrome. A trial implant was performed with a peripheral V2 trigeminal lead and a C1-C2 lead in cross-talk configuration. During permanent implant, the V2 lead was placed uneventfully while the central lead could only be advanced to C3-C4. During the trial, pain decreased by 70%. One month after permanent implant, the patient still experienced a 60-70% reduction in pain levels and a decrease from ten to two weekly pain episodes. Nine months post implant, the patient reported complete pain relief (0/10 on a numeric rating scale ranging from 0 to 10) and medications were discontinued. Infrequent exacerbations (3/10) were controlled by increasing stimulation. Three years post implant, the patient continued to have no baseline pain and could easily control exacerbations. Cross-talk configuration between a peripheral and a central lead created a more efficient stimulation technique. The resulting paresthesia was superior to that obtained from either lead alone and exceeded the paresthesia obtained from the combination of the two leads when used simultaneously, without an inter-lead configuration. © 2016 International Neuromodulation Society.

Pacemaker Dependency after Cardiac Surgery: A Systematic Review of Current Evidence.

PubMed

Steyers, Curtis M; Khera, Rohan; Bhave, Prashant

2015-01-01

Severe postoperative conduction disturbances requiring permanent pacemaker implantation frequently occur following cardiac surgery. Little is known about the long-term pacing requirements and risk factors for pacemaker dependency in this population. We performed a systematic review of the literature addressing rates and predictors of pacemaker dependency in patients requiring permanent pacemaker implantation after cardiac surgery. Using a comprehensive search of the Medline, Web of Science and EMBASE databases, studies were selected for review based on predetermined inclusion and exclusion criteria. A total of 8 studies addressing the endpoint of pacemaker-dependency were identified, while 3 studies were found that addressed the recovery of atrioventricular (AV) conduction endpoint. There were 10 unique studies with a total of 780 patients. Mean follow-up ranged from 6-72 months. Pacemaker dependency rates ranged from 32%-91% and recovery of AV conduction ranged from 16%-42%. There was significant heterogeneity with respect to the definition of pacemaker dependency. Several patient and procedure-specific variables were found to be independently associated with pacemaker dependency, but these were not consistent between studies. Pacemaker dependency following cardiac surgery occurs with variable frequency. While individual studies have identified various perioperative risk factors for pacemaker dependency and non-resolution of AV conduction disease, results have been inconsistent. Well-conducted studies using a uniform definition of pacemaker dependency might identify patients who will benefit most from early permanent pacemaker implantation after cardiac surgery.

Brachytherapy

MedlinePlus

... care for brachytherapy catheters. top of page What equipment is used? For permanent implants, radioactive material (which ... the tumor. top of page Who operates the equipment? The equipment is operated by a medical physicist, ...

Implantable Heart Aid

NASA Technical Reports Server (NTRS)

1980-01-01

Medrad utilized NASA's Apollo technology to develop a new device called the AID implantable automatic pulse generator which monitors the heart continuously, recognizes the onset of ventricular fibrillation and delivers a corrective electrical shock. AID pulse generator is, in effect, a miniaturized version of the defibrillator used by emergency squads and hospitals to restore rhythmic heartbeat after fibrillation, but has the unique advantage of being permanently available to the patient at risk. Once implanted, it needs no specially trained personnel or additional equipment. AID system consists of a microcomputer, a power source and two electrodes which sense heart activity.

The usefulness of a stretch-polyester pouch to encase implanted pacemakers and defibrillators.

PubMed

Parsonnet, V; Bernstein, A D; Neglia, D; Omar, A

1994-12-01

This study was undertaken to assess the effects of enclosing permanent pacemaker and ICD pulse generators in a stretch-polyester pouch prior to implantation. Follow-up of 223 patients with oversized pacemakers and with ICDs and 344 with standard-sized pacemaker pulse generators showed that the pouch was effective in decreasing the frequency of pulse generator migration and extrusion.

Implantable Myoelectric Sensors (IMESs) for Intramuscular Electromyogram Recording

PubMed Central

Weir, Richard F. ff.; Troyk, Phil R.; DeMichele, Glen A.; Kerns, Douglas A.; Schorsch, Jack F.; Maas, Huub

2011-01-01

We have developed a multichannel electrogmyography sensor system capable of receiving and processing signals from up to 32 implanted myoelectric sensors (IMES). The appeal of implanted sensors for myoelectric control is that electromyography (EMG) signals can be measured at their source providing relatively cross-talk-free signals that can be treated as independent control sites. An external telemetry controller receives telemetry sent over a transcutaneous magnetic link by the implanted electrodes. The same link provides power and commands to the implanted electrodes. Wireless telemetry of EMG signals from sensors implanted in the residual musculature eliminates the problems associated with percutaneous wires, such as infection, breakage, and marsupialization. Each implantable sensor consists of a custom-designed application-specified integrated circuit that is packaged into a bio-compatible RF BION capsule from the Alfred E. Mann Foundation. Implants are designed for permanent long-term implantation with no servicing requirements. We have a fully operational system. The system has been tested in animals. Implants have been chronically implanted in the legs of three cats and are still completely operational four months after implantation. PMID:19224729

Dermis-Fat Graft in Children as Primary and Secondary Orbital Implant.

PubMed

Quaranta-Leoni, Francesco M; Sposato, Sabrina; Raglione, Pietro; Mastromarino, Angelo

2016-01-01

To report the experience with the use of dermis-fat graft in the pediatric population and to evaluate the outcome of this procedure as a primary or secondary orbital implant. Case series. Analysis of the clinical charts of 22 patients. Age at the time of surgery ranged from 2.1 to 13 years. Three patients affected were submitted to evisceration with primary dermis-fat graft. Six patients had explantation of exposed implants and a replacement with a dermis-fat graft. Three patients had a dermis-fat graft to repair contracted sockets. Ten patients were affected by congenital anophthalmia: 4 patients had a primary dermis-fat graft, 6 patients had a removal of a socket expander, or an orbital spherical expander, or pellet expanders and a replacement with a dermis-fat graft. This study adheres to the principles outlined in the Declaration of Helsinki. The patients' follow up ranged between 2.5 and 8 years. Only 1 child who had a primary dermis-fat graft experienced excessive growth of the implant, managed by surgical debulking. In the end, all the patients showed satisfactory orbital volume along with adequate fornices. The dermis-fat graft as a primary implant may be useful in children with severe scleromalacia or following ocular trauma. It is a suitable option in children affected by congenital anophthalmia as it helps continued socket expansion. It can also be considered in the pediatric population to address the volume deficit following explantation of exposed implants and in contracted sockets.

Evaluation of an integrated orbital tissue expander in congenital anophthalmos: report of preliminary clinical experience.

PubMed

Tse, David T; Abdulhafez, Mohammad; Orozco, Marcia A; Tse, Jeffrey D; Azab, Amr Osama; Pinchuk, Leonard

2011-03-01

To evaluate the effectiveness of an orbital tissue expander designed to stimulate orbital bone growth in an anophthalmic socket. Retrospective, noncomparative, interventional case series. Institutional. Nine consecutive patients with unilateral congenital anophthalmos. The orbital tissue expander is made of an inflatable silicone globe sliding on a titanium T-plate secured to the lateral orbital rim with screws. The globe is inflated by a transconjunctival injection of normal saline through a 30-gauge needle to a final volume of approximately 5 cm(3). Computed tomography scans were used to determine the orbital volume. The data studied were: demographics, prior orbital expansion procedures, secondary interventions, orbital symmetry, and implant-related complications. The primary outcome measure was the orbital volume change, and the secondary outcome measures were changes in forehead, brow, and zygomatic eminence contour and adverse events. The average patient age at implantation was 41.89 ± 39.42 months (range, 9 to 108 months). The initial average volume of inflation was 3.00 ± 0.87 cm(3) (range, 2.0 to 4.0 cm(3)), and the average final volume of 4.33 ± 0.50 cm(3) (range, 4.0 to 5.0 cm(3)) was achieved. The duration of expansion was 18.89 ± 8.80 months (range, 4 to 26 months). All patients demonstrated an average increase in the orbital tissue expander implanted orbital volume of 5.112 ± 2.173 cm(3) (range, 2.81 to 10.38 cm(3)). The average difference between the volume of the implanted and the initial contralateral orbit was 5.68 ± 2.34 cm(3), which decreased to 2.53 ± 1.80 cm(3) at the final measurement (P < .001, paired t test). All implants remained inflated except for 2 iatrogenic punctures at the second inflation and 1 that was the result of implant failure. All were replaced. The integrated orbital tissue expander is safe and effective in stimulating anophthalmic socket bone growth. Copyright © 2011 Elsevier Inc. All rights reserved.

Ejaculatory Function After Permanent {sup 125}I Prostate Brachytherapy for Localized Prostate Cancer

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

Huyghe, Eric; Department of Urology and Andrology, Paul Sabatier University, CHU Paule de Viguier, Toulouse; Delannes, Martine

Purpose: Ejaculatory function is an underreported aspect of male sexuality in men treated for prostate cancer. We conducted the first detailed analysis of ejaculatory function in patients treated with permanent {sup 125}I prostate brachytherapy for localized prostate cancer. Patients and Methods: Of 270 sexually active men with localized prostate cancer treated with permanent {sup 125}I prostate brachytherapy, 241 (89%), with a mean age of 65 years (range, 43-80), responded to a mailed questionnaire derived from the Male Sexual Health Questionnaire regarding ejaculatory function. Five aspects of ejaculatory function were examined: frequency, volume, dry ejaculation, pleasure, and pain. Results: Of themore » 241 sexually active men, 81.3% had conserved ejaculatory function after prostate brachytherapy; however, the number of patients with rare/absent ejaculatory function was double the pretreatment number (p < .0001). The latter finding was correlated with age (p < .001) and the preimplant International Index of Erectile Function score (p < .001). However, 84.9% of patients with maintained ejaculatory function after implantation reported a reduced volume of ejaculate compared with 26.9% before (p < .001), with dry ejaculation accounting for 18.7% of these cases. After treatment, 30.3% of the patients experienced painful ejaculation compared with 12.9% before (p = .0001), and this was associated with a greater number of implanted needles (p = .021) and the existence of painful ejaculation before implantation (p < .0001). After implantation, 10% of patients who continued to be sexually active experienced no orgasm compared with only 1% before treatment. in addition, more patients experienced late/difficult or weak orgasms (p = .001). Conclusion: Most men treated with brachytherapy have conserved ejaculatory function after prostate brachytherapy. However, most of these men experience a reduction in volume and a deterioration in orgasm.« less

Ejaculatory function after permanent 125I prostate brachytherapy for localized prostate cancer.

PubMed

Huyghe, Eric; Delannes, Martine; Wagner, Fabien; Delaunay, Boris; Nohra, Joe; Thoulouzan, Matthieu; Shut-Yee, J Yeung; Plante, Pierre; Soulie, Michel; Thonneau, Patrick; Bachaud, Jean Marc

2009-05-01

Ejaculatory function is an underreported aspect of male sexuality in men treated for prostate cancer. We conducted the first detailed analysis of ejaculatory function in patients treated with permanent (125)I prostate brachytherapy for localized prostate cancer. Of 270 sexually active men with localized prostate cancer treated with permanent (125)I prostate brachytherapy, 241 (89%), with a mean age of 65 years (range, 43-80), responded to a mailed questionnaire derived from the Male Sexual Health Questionnaire regarding ejaculatory function. Five aspects of ejaculatory function were examined: frequency, volume, dry ejaculation, pleasure, and pain. Of the 241 sexually active men, 81.3% had conserved ejaculatory function after prostate brachytherapy; however, the number of patients with rare/absent ejaculatory function was double the pretreatment number (p < .0001). The latter finding was correlated with age (p < .001) and the preimplant International Index of Erectile Function score (p < .001). However, 84.9% of patients with maintained ejaculatory function after implantation reported a reduced volume of ejaculate compared with 26.9% before (p < .001), with dry ejaculation accounting for 18.7% of these cases. After treatment, 30.3% of the patients experienced painful ejaculation compared with 12.9% before (p = .0001), and this was associated with a greater number of implanted needles (p = .021) and the existence of painful ejaculation before implantation (p < .0001). After implantation, 10% of patients who continued to be sexually active experienced no orgasm compared with only 1% before treatment. in addition, more patients experienced late/difficult or weak orgasms (p = .001). Most men treated with brachytherapy have conserved ejaculatory function after prostate brachytherapy. However, most of these men experience a reduction in volume and a deterioration in orgasm.

Spinal cord stimulation

MedlinePlus

... wires will be connected to a small current generator outside of your body that you carry like ... your pain, you will be offered a permanent generator. The generator will be implanted a few weeks ...

Sick sinus syndrome

MedlinePlus

... the heart (atria). This area is the heart's pacemaker. It may be called the sinoatrial node, sinus ... do so. You may need a permanent implanted pacemaker if your symptoms are related to bradycardia (slow ...

Malignant tumors of the maxilla: virtual planning and real-time rehabilitation with custom-made R-zygoma fixtures and carbon-graphite fiber-reinforced polymer prosthesis.

PubMed

Ekstrand, Karl; Hirsch, Jan-M

2008-03-01

Oral cancer is a mutilating disease. Because of the expanding application of computer technology in medicine, new methods are constantly evolving. This project leads into a new technology in maxillofacial reconstructive therapy using a redesigned zygoma fixture. Previous development experiences showed that the procedure was time-consuming and painful for the patients. Frequent episodes of sedation or general anesthetics were required and the rehabilitation is costly. The aim of our new treatment goal was to allow the patients to wake up after tumor surgery with a functional rehabilitation in place. Stereolithographic models were introduced to produce a model from the three-dimensional computed tomography (CT). A guide with the proposed resection was fabricated, and the real-time maxillectomy was performed. From the postoperative CT, a second stereolithographic model was manufactured and in addition, a stent for the optimal position of the implants. Customized zygoma implants were installed (R-zygoma, Integration AB, Göteborg, Sweden). A fixed construction was fabricated by using a new material based on poly(methylacrylate) reinforced with carbon/graphite fibers and attached to the implants. On the same master cast, a separate obturator was fabricated in permanent soft silicon. The result of this project showed that it was possible to create a virtual plan preoperatively to apply during surgery in order for the patient to wake up functionally rehabilitated. From a quality-of-life perspective, it is an advantage to be rehabilitated fast. By using new computer technology, pain and discomfort are less and the total rehabilitation is faster, which in turn reduces days in hospital and thereby total costs.

Evaluation of fixation of expandable implants in the mandibles of ovariectomized sheep.

PubMed

Xiao, Jian-Rui; Li, De-Hua; Chen, Yu-Xuan; Chen, Shu-Jun; Guan, Su-Min; Kong, Liang

2013-04-01

This study aimed to investigate the effects of an expandable implant (EI) in ovariectomized sheep. The EI and taper implant (control group) were produced and placed in mandibles of ovariectomized sheep. Twelve weeks after implantation, resonance frequency analysis, biomechanical tests, histomorphometry, and micro-computed tomography were applied to detect the osseointegration in the 2 groups. The implant stability quotient values, maximal pullout forces, and bone-implant contact (BIC) were 60.3 ± 7.9, 511.0 ± 18.7 N, and 53.14% ± 4.56%, respectively, in the EI group and 58.3 ± 8.9, 394.5 ± 54.5 N, and 46.85% ± 5.04%, respectively, in the control group. There was no significant difference between the 2 groups in implant stability quotient values (P > .05); however, in the EI group the maximal pullout force and BIC were increased significantly (P < .05 and P < .01, respectively). Micro-computed tomography analysis showed that the bone volume/total volume ratio and trabecular number increased significantly (P < .01) and trabecular separation decreased significantly (P < .05) in the EI group. EI could improve osseointegration in osteoporosis after 12 weeks of implantation by increasing BIC around the implant and by supplying an extra osseointegration surface. Copyright © 2013 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Three-dimensional verification of ¹²⁵I seed stability after permanent implantation in the parotid gland and periparotid region.

PubMed

Fan, Yi; Huang, Ming-Wei; Zheng, Lei; Zhao, Yi-Jiao; Zhang, Jian-Guo

2015-11-24

To evaluate seed stability after permanent implantation in the parotid gland and periparotid region via a three-dimensional reconstruction of CT data. Fifteen patients treated from June 2008 to June 2012 at Peking University School and Hospital of Stomatology for parotid gland tumors with postoperative adjunctive (125)I interstitial brachytherapy were retrospectively reviewed in this study. Serial CT data were obtained during follow-up. Mimics and Geomagic Studio software were used for seed reconstruction and stability analysis, respectively. Seed loss and/or migration outside of the treated area were absent in all patients during follow-up (23-71 months). Total seed cluster volume was maximized on day 1 post-implantation due to edema and decreased significantly by an average of 13.5 % (SD = 9.80 %; 95 % CI, 6.82-17.68 %) during the first two months and an average of 4.5 % (SD = 3.60 %; 95 % CI, 2.29-6.29 %) during the next four months. Volume stabilized over the subsequent six months. (125)I seed number and location were stable with a general volumetric shrinkage tendency in the parotid gland and periparotid region. Three-dimensional seed reconstruction of CT images is feasible for visualization and verification of implanted seeds in parotid brachytherapy.

Technique of after-loading interstitial implants.

PubMed

Syed, A M; Feder, B H

1977-01-01

Interstitial implants are either removable or permanent (and occasionally a combination of both). Permanent implants are generally utilized where tumors are not accessible enough to permit easy removal of sources or where accurate source distribution is less critical. They are useful for cancers of the lung, pancreas, prostate, bladder, lymph nodes, etc. Radon and gold-198 have been largely replaced by iodine-125. Our major interests are in the removable after-loading iridium-192 implant techniques. Template (steel guide) and non-template (plastic tube) techniques are utilized. Templates are preferred where the tumor volume can only be approached from one side and where accurate positioning of sources would otherwise be difficult. They are useful for cancers of the cervix, vagina, urethra, and rectum. Non-template (plastic tube) techniques are preferred where the tumor volume can be approached from at least two sides and where templates are either not feasible or not essential for accurate positioning of sources. The single needle non-template approach is useful for cancers of lip, nodes, and breast (plastic button) and for cancers of the oral cavity and oropharynx (gold button). The paired needle non-template approach is useful for cancers of the gum, retromolar trigone, and base of tongue (loop technique) and for cancers of the palate (arch technique). Procedures for each technique are described in detail.

The Prognostic Impact of New-Onset Persistent Left Bundle Branch Block Following Transcatheter Aortic Valve Implantation: A Meta-analysis.

PubMed

Ando, Tomo; Takagi, Hisato

2016-09-01

New-onset persistent left bundle branch block (NOP-LBBB) is one of the most common conduction disturbances after transcatheter aortic valve implantation (TAVI). We hypothesized that NOP-LBBB may have a clinically negative impact after TAVI. To find out, we conducted a systematic literature search of the MEDLINE/PubMed and Embase databases. Observational studies that reported clinical outcomes of NOP-LBBB patients after TAVI were included. The random-effects model was used to combine odds ratios, risk ratios, or hazard ratios (HRs) with 95% confidence intervals. Adjusted HRs were utilized over unadjusted HRs or risk ratios when available. A total of 4049 patients (807 and 3242 patients with and without NOP-LBBB, respectively) were included. Perioperative (in-hospital or 30-day) and midterm all-cause mortality and midterm cardiovascular mortality were comparable between the groups. The NOP-LBBB patients experienced a higher rate of permanent pacemaker implantation (HR: 2.09, 95% confidence interval: 1.12-3.90, P = 0.021, I(2) = 83%) during midterm follow-up. We found that NOP-LBBB after TAVI resulted in higher permanent pacemaker implantation but did not negatively affect the midterm prognosis. Therefore, careful observation during the follow-up is required. © 2016 Wiley Periodicals, Inc.

Comparison of acellular dermal matrix and synthetic mesh for lateral chest wall reconstruction in a rabbit model.

PubMed

Holton, Luther H; Chung, Thomas; Silverman, Ronald P; Haerian, Hafez; Goldberg, Nelson H; Burrows, Whitney M; Gobin, Andrea; Butler, Charles E

2007-04-01

Synthetic mesh is used for chest wall reconstruction, but infection or exposure can occur and necessitate removal. Human acellular dermal matrix (AlloDerm) has been used to reconstruct musculofascial defects in the trunk with low infection and herniation rates. AlloDerm may have advantages over synthetic mesh for chest wall reconstruction. This study compared outcomes and repair strengths of AlloDerm to expanded polytetrafluoroethylene mesh used for repair of rib cage defects. A 3 x 3-cm, full-thickness, lateral rib cage defect was created in each rabbit and repaired with expanded polytetrafluoroethylene (n = 8) or acellular dermal matrix (n = 9). At 4 weeks, the animals were euthanized and evaluated for lung herniation/dehiscence, strength of adhesions between the implant and intrapleural structures, and breaking strength of the implant materials and the implant-fascia interface. Tissue sections were analyzed with histologic and immunohistochemical staining to evaluate cellular infiltration and vascularization. No herniation or dehiscence occurred with either material. The incidence and strength of adhesions was similar between materials. The mean breaking strength of the AlloDerm-fascia interface (14.5 +/- 8.9 N) was greater than the expanded polytetrafluoroethylene-fascia interface (8.7 +/- 4.4 N; p = 0.027) and similar to the rib-intercostal-rib interface of the contralateral native chest wall (14.0 +/- 5.6 N). The AlloDerm grafts became infiltrated with cells and vascularized after implantation. AlloDerm used for chest wall reconstruction results in greater implant-defect interface strength than expanded polytetrafluoroethylene. The ability of AlloDerm to become vascularized and remodeled by autologous cells and to resist infection may be advantageous for chest wall reconstruction.

Transapical Aortic Valve Replacement under Real-time Magnetic Resonance Imaging Guidance: Experimental Results with Balloon-Expandable and Self-Expanding Stents

PubMed Central

Horvath, Keith A.; Mazilu, Dumitru; Kocaturk, Ozgur; Li, Ming

2010-01-01

Objective Aortic valves have been implanted on self-expanding (SE) and balloon-expandable (BE) stents minimally invasively. We have demonstrated the advantages of transapical aortic valve implantation (tAVI) under real-time magnetic resonance imaging (rtMRI) guidance. Whether there are different advantages to SE or BE stents is unknown. We report rtMRI guided tAVI in a porcine model using both SE and BE stents, and compare the differences between the stents. Methods Twenty-two Yucatan pigs (45-57kgs.) underwent tAVI. Commercially available stentless bioprostheses (21-25mm) were mounted on either BE platinum-iridium stents or SE nitinol stents. rtMRI guidance was employed as the intraoperative imaging. Markers on both types of stents were used to enhance the visualization in rtMRI. Pigs were allowed to survive and had follow-up MRI scans and echocardiography at 1, 3 and 6 months postoperatively. Results rtMRI provided excellent visualization of the aortic valve implantation mounted on both stent types. The implantation times were shorter with the SE stents (60±14 seconds) than BE (74±18s), (p=0.027). Total procedure time was 31 and 37 minutes respectively (p=0.12). It was considerably easier to manipulate the SE stent during deployment without hemodynamic compromise. This was not always the case with the BE stent and its placement occasionally resulted in coronary obstruction and death. Long-term results demonstrated stability of the implants with preservation of myocardial perfusion and function over time for both stents. Conclusions SE stents were easier to position and deploy thus leading to fewer complications during tAVI. Future optimization of SE stent design should improve clinical results. PMID:20971017

Conjunctival Expansion Using a Subtenon's Silicone Implant in New Zealand White Rabbits

PubMed Central

Yoon, Ie-na; Lee, Dong-hoon

2007-01-01

Purpose In the field of ophthalmology, the conjunctival autograft is a useful therapeutic material in many cases, but the small size of the autograft is a disadvantage. Therefore, we evaluated the feasibility of taking an expanded sample of conjunctival tissue using a subtenon's silicone implant. Materials and Methods We included a total of nine rabbits; eight rabbits were operative cases, and one was a control. A portion of conjunctival tissue from the control rabbit, which did not undergo surgery, was dissected and examined to determine whether it was histologically different from the experimental group. The surgical procedure was performed on eight rabbits via a subtenon's insertion of a silicone sponge in the left superior-temporal portion; after surgery, we dropped antibiotics into the eyes. We sacrificed a pair of rabbits every three days (on days 3, 6, 9, and 12) after surgery, removed the expanded conjunctival tissues with the silicone sponge implants, and measured their sizes. Results The mean size of the expanded conjunctival tissues was 194.4 mm2. On the third day, we were able to harvest a 223.56 mm2 section of conjunctival tissue, which was the most expanded sample of tissue in the study. On the twelfth day, we removed a 160.38 mm2 section of conjunctival tissue, which was the least expanded sample of tissue. Statistically, there were no significant differences in the mean dimensions of the expanded conjunctival tissues for each time period. Microscopic examinations showed no histological differences between the expanded conjunctival tissues and the normal conjunctival tissues. Conclusion The results reveal that this procedure is a useful method to expand the conjunctiva for grafting and transplantation. PMID:18159586

A new self-expandable aortic valved stent deployed above native leaflets for aortic insufficiency: an in vitro study.

PubMed

Huang, H; Zhou, Y; Shao, J; Cai, J; Mei, Y; Wang, Y

2012-12-01

The aim of this paper was to develop a new self-expandable aortic valved stent following the shape of the sinus of Valsalva, which can be deployed above native leaflets for aortic regurgitation, and study it's effect on coronary artery flow when orthotopic implantation in and above native leaflets. New self-expandable aortic valved stent consist of nitinol stent and bovine pericardium, and was designed following the shape of the sinus of Valsalva, the bovine pericardium was tailed as native leaflet. Thirty-six swine hearts were divided into three equal groups of twelve. In Group A (N.=12), the new self-expandable aortic valved stents deployed in native leaflets. In Group B (N.=12), the new self-expandable aortic valved stents deployed above native leaflets. In Group C (N.=12), the cylinder-like valved stents deployed only in native leaflets. The measurements of each coronary flow rate and endoscopic inspections were repeated post-implantation. In Group A and C, valve implantation in native leaflets resulted in a significant decrease in both left and right coronary flows. In Group B, no significant change in either right or left coronary flow was found after new self-expandable aortic valved stent placement. Endoscopic inspections showed that in group A and C the native leaflets sandwiched between valved stent and aortic wall, whereas, in group B the native leaflets were under the artificial leaflets. Two kinds of stents deployed in native leaflets affect left and right coronary flows significantly. No significant effect was found when the new self-expandable aortic valved stent deployed above native leaflets. This new self-expandable aortic valved stent can be deployed above the native leaflets, which avoids the obstruction of native leaflets on coronary flow.

Histological Evaluation of a Self-Expanding Stent-Graft 23 Months After Implantation in the Superficial Femoral Artery.

PubMed

Ishihara, Takayuki; Iida, Osamu; Inoue, Katsumi; Fujita, Masashi; Masuda, Masaharu; Okamoto, Shin; Nanto, Kiyonori; Kanda, Takashi; Tsujimura, Takuya; Sunaga, Akihiro; Mano, Toshiaki; Uematsu, Masaaki

2017-10-01

To report histological examination of a Viabahn stent-graft implanted in the superficial femoral artery (SFA) for nearly 2 years. A 78-year-old man with peripheral artery disease was treated successfully with a 6.0×250-mm Viabahn self-expanding stent-graft in the right SFA, relieving his lower limb claudication. The patient died suddenly due to acute myocardial infarction 23 months later. Histological evaluation of the stent-graft implantation site revealed moderate neointimal proliferation at both proximal and distal edges of the device. In the middle part of the stent, significant macrophages and multinucleated foreign body giant cells had accumulated, although the stent was entirely patent. Furthermore, no endothelial cell coverage was found. Judging from these features, it might be necessary to continue dual antiplatelet therapy after stent-graft implantation over the long term to prevent thrombosis and subsequent restenosis or reocclusion.

Effectiveness of Family Planning Methods

MedlinePlus

... women in a year Effectiveness of Family Planning Methods Implant Reversible Intrauterine Device (IUD) Permanent Male Sterilization ... 0.5 % Diaphragm 12 % How to make your method most effective After procedure, little or nothing to ...

Exercise Balikatan 2012 Technology Insertion Quicklook Report

DTIC Science & Technology

2012-05-15

expanded polystyrene panels covered with a thin layer of cement, sand, fiberglass, and other additives. A permanent 200 sq ft building with windows... Expanded Polystyrene 1.5# density pre-cut panels and GFRC -Glass Fiber Reinforced Concrete Structural coating (Fiberglass Mesh, Portland Cement, Silica

Surface coating for prevention of metallic seed migration in tissues

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

Lee, Hyunseok; Park, Jong In; Lee, Won Seok

Purpose: In radiotherapy, metallic implants often detach from their deposited sites and migrate to other locations. This undesirable migration could cause inadequate dose coverage for permanent brachytherapy and difficulties in image-guided radiation delivery for patients. To prevent migration of implanted seeds, the authors propose a potential strategy to use a biocompatible and tissue-adhesive material called polydopamine. Methods: In this study, nonradioactive dummy seeds that have the same geometry and composition as commercial I-125 seeds were coated in polydopamine. Using scanning electron microscopy and x-ray photoelectron spectroscopy, the surface of the polydopamine-coated and noncoated seeds was characterized. The detachment stress betweenmore » the two types of seeds and the tissue was measured. The efficacy of polydopamine-coated seed was investigated through in vitro migration tests by tracing the seed location after tissue implantation and shaking for given times. The cytotoxicity of the polydopamine coating was also evaluated. Results: The results of the coating characterization have shown that polydopamine was successfully coated on the surface of the seeds. In the adhesion test, the polydopamine-coated seeds had 2.1-fold greater detachment stress than noncoated seeds. From the in vitro test, it was determined that the polydopamine-coated seed migrated shorter distances than the noncoated seed. This difference was increased with a greater length of time after implantation. Conclusions: The authors suggest that polydopamine coating is an effective technique to prevent migration of implanted seeds, especially for permanent prostate brachytherapy.« less

Clinical characteristics associated with pacing-induced cardiac dysfunction: a high incidence of undiagnosed cardiac sarcoidosis before permanent pacemaker implantation.

PubMed

Wakabayashi, Yasushi; Mitsuhashi, Takeshi; Akashi, Naoyuki; Hayashi, Takekuni; Umemoto, Tomio; Sugawara, Yoshitaka; Fujita, Hideo; Momomura, Shin-Ichi

2018-06-21

Previous studies suggested that right ventricular pacing was associated with pacing-induced cardiac dysfunction (PICD). The purpose of this study was to investigate the clinical characteristics including the incidence of undiagnosed cardiac sarcoidosis (CS) in patients with atrioventricular block (AVB) who manifest PICD. We retrospectively investigated consecutive patients with permanent pacemaker (PPM) undergoing a first-generator replacement surgery with a new PPM or an upgrade procedure to a cardiac resynchronization therapy (CRT) device between December 1, 2011 and June 30, 2017. Patients with AVB showing normal echocardiographic findings before PPM implantation were included and divided into 2 groups: patients with post-PPM left ventricular ejection fraction (LVEF) < 40% and/or undergoing an upgrade procedure to CRT (PICD group) and patients with post-PPM LVEF ≥ 40% who underwent replacement surgery with a new PPM (no-PICD group). There were 15 and 41 patients in the PICD and no-PICD groups, respectively. A wider-paced QRS duration just after the PPM implantation and/or lower pre-PPM LVEF was observed in the PICD group. Furthermore, 46.7% of the PICD patients (7/15) satisfied the diagnostic criteria for CS according to the guideline of the Japanese Circulation Society, although no patients fulfilled these criteria before PPM implantation. In conclusion, a high incidence of CS was observed in patients with AVB who had PICD. However, none of these patients was diagnosed with CS before PPM implantation.

Isovolumic loading of the failing heart by intraventricular placement of a spring expander attenuates cardiac atrophy after heterotopic heart transplantation.

PubMed

Pokorný, Martin; Mrázová, Iveta; Šochman, Jan; Melenovský, Vojtěch; Malý, Jiří; Pirk, Jan; Červenková, Lenka; Sadowski, Janusz; Čermák, Zdeněk; Volenec, Karel; Vacková, Šárka; Maxová, Hana; Červenka, Luděk; Netuka, Ivan

2018-05-09

Cardiac atrophy is the most common complication of prolonged application of the left ventricle assist device in patients with advanced heart failure. Our aim was to evaluate the course of unloading-induced cardiac atrophy in rats with failing hearts, and to examine if increased isovolumic loading obtained by intraventricular implantation of an especially designed spring expander would attenuate this process. Heterotopic abdominal heart transplantation (HT x ) was used as a rat model of heart unloading. Heart failure (HF) was induced by volume overload achieved by creation of the aorto-caval fistula. The degree of cardiac atrophy was assessed as the weight ratio of the heterotopically transplanted heart (HW) to the control heart. Isovolumic loading was increased by intraventricular implantation of a stainless steel three-branch spring expander. The course of cardiac atrophy was evaluated on days 7, 14, 21 and 28 after HT x Seven-days unloading by HT x in failing hearts sufficed to substantially decrease HW (-59 ± 3%), the decrease progressed when measured on days 14, 21 and 28 after HT x Implantation of the spring expander significantly reduced the decreases in whole HW at all the time-points (-39 ± 3 vs. -59 ± 3, -52 ± 2 vs. -69 ± 3, -51 ± 2 vs. - 71 ± 2 and -44 ± 2 vs. -71 ± 3%, respectively; p<0.05 in each case). We conclude that the enhanced isovolumic heart loading obtained by implantation of the spring expander attenuates the development of unloading-induced cardiac atrophy in the failing rat heart. ©2018 The Author(s).

A classification of growth friendly spine implants.

PubMed

Skaggs, David L; Akbarnia, Behrooz A; Flynn, John M; Myung, Karen S; Sponseller, Paul D; Vitale, Michael G

2014-01-01

Various types of spinal implants have been used with the objective of minimizing spinal deformities while maximizing the spine and thoracic growth in a growing child with a spinal deformity. The aim of this study was to describe a classification system of growth friendly spinal implants to allow researchers and clinicians to have a common language and facilitate comparative studies. Growth friendly spinal implant systems fall into 3 categories based upon the forces of correction the implants exert on the spine, which are as follows: Distraction-based systems correct spinal deformities by mechanically applying a distractive force across a deformed segment with anchors at the top and bottom of the implants, which commonly attach to the spine, rib, and/or the pelvis. The present examples of distraction-based implants are spine-based or rib-based growing rods, vertical expandable titanium rib prosthesis, and remotely expandable devices. Compression-based systems correct spinal deformities with a compressive force applied to the convexity of the curve causing convex growth inhibition. This compressive force may be generated both mechanically at the time of implantation, as well as over time resulting from longitudinal growth of vertebral endplates hindered by the spinal implants. Examples of compression-based systems are vertebral staples and tethers. Guided growth systems correct spinal deformity by anchoring multiple vertebrae (usually including the apical vertebrae) to rods with mechanical forces including translation at the time of the initial implant. The majority of the anchors are not rigidly attached to the rods, thus permitting longitudinal growth over time as the anchors slide over the rods. Examples of guided growth systems include the Luque trolley and Shilla. Each system has its benefits and shortcomings. Knowledge of the fundamental principles upon which these systems are based may aid the clinician to choose an appropriate treatment for patients. Having a common language for these systems may aid in comparative research. Vertical expandable titanium rib prosthesis is used with humanitarian exemption. The other devices mentioned in this manuscript are not approved for growing constructs by the Food and Drug Administration and are used off-label.

Pacemaker Dependency after Cardiac Surgery: A Systematic Review of Current Evidence

PubMed Central

2015-01-01

Background Severe postoperative conduction disturbances requiring permanent pacemaker implantation frequently occur following cardiac surgery. Little is known about the long-term pacing requirements and risk factors for pacemaker dependency in this population. Methods We performed a systematic review of the literature addressing rates and predictors of pacemaker dependency in patients requiring permanent pacemaker implantation after cardiac surgery. Using a comprehensive search of the Medline, Web of Science and EMBASE databases, studies were selected for review based on predetermined inclusion and exclusion criteria. Results A total of 8 studies addressing the endpoint of pacemaker-dependency were identified, while 3 studies were found that addressed the recovery of atrioventricular (AV) conduction endpoint. There were 10 unique studies with a total of 780 patients. Mean follow-up ranged from 6–72 months. Pacemaker dependency rates ranged from 32%-91% and recovery of AV conduction ranged from 16%-42%. There was significant heterogeneity with respect to the definition of pacemaker dependency. Several patient and procedure-specific variables were found to be independently associated with pacemaker dependency, but these were not consistent between studies. Conclusions Pacemaker dependency following cardiac surgery occurs with variable frequency. While individual studies have identified various perioperative risk factors for pacemaker dependency and non-resolution of AV conduction disease, results have been inconsistent. Well-conducted studies using a uniform definition of pacemaker dependency might identify patients who will benefit most from early permanent pacemaker implantation after cardiac surgery. PMID:26470027

Evaluation of Death among the Patients Undergoing Permanent Pacemaker Implantation: A Competing Risks Analysis.

PubMed

Ghaem, Haleh; Ghorbani, Mohammad; Zare Dorniani, Samira

2017-06-01

Permanent artificial pacemaker is one of the important therapies for treatment of cardiac conduction system problems. The present study aimed to determine the association between some predictive variables and all-cause and cause-specific mortality in the patients who had undergone pacemaker implantation. This study was conducted on 1207 patients who had undergone permanent pacemaker implantation in the hospitals affiliated with Shiraz University of Medical Sciences, Iran, from Mar 2002 to Mar 2012. The variables that existed in the patients' medical records included sex, diabetes mellitus, obesity, cerebrovascular accident, cardiomegaly, smoking, hypertension, ischemic heart disease, congenital heart disease, sick sinus syndrome, and atrial fibrillation. Competing risks model was used to assess the association between the predictive variables and cause-specific (i.e., cardiac and vascular) mortality. The patients' mean age was 66.32±17.92 yr (70.62±14.45 yr in the patients with single-chamber pacemakers vs. 61.91±17.69 yr in those with two-chamber pacemakers) ( P <0.001). Sick sinus syndrome and age increased the risk of all-cause mortality, while two-chamber pacemaker decreased this risk. Obesity increased the risk of cardiac death, and diabetes mellitus and heart valve disease increased the risk of vascular death. The variables predicting mortality in all-cause model were completely different from those in cause-specific model. Moreover, death in such patients may occur due to reasons other than pacemaker. Therefore, future studies, particularly prospective ones, are recommended to use competing risks models.

Dose escalation in permanent brachytherapy for prostate cancer: dosimetric and biological considerations

NASA Astrophysics Data System (ADS)

Li, X. Allen; Wang, Jian Z.; Stewart, Robert D.; Di Biase, Steven J.

2003-09-01

No prospective dose escalation study for prostate brachytherapy (PB) with permanent implants has been reported. In this work, we have performed a dosimetric and biological analysis to explore the implications of dose escalation in PB using 125I and 103Pd implants. The concept of equivalent uniform dose (EUD), proposed originally for external-beam radiotherapy (EBRT), is applied to low dose rate brachytherapy. For a given 125I or 103Pd PB, the EUD for tumour that corresponds to a dose distribution delivered by EBRT is calculated based on the linear quadratic model. The EUD calculation is based on the dose volume histogram (DVH) obtained retrospectively from representative actual patient data. Tumour control probabilities (TCPs) are also determined in order to compare the relative effectiveness of different dose levels. The EUD for normal tissue is computed using the Lyman model. A commercial inverse treatment planning algorithm is used to investigate the feasibility of escalating the dose to prostate with acceptable dose increases in the rectum and urethra. The dosimetric calculation is performed for five representative patients with different prostate sizes. A series of PB dose levels are considered for each patient using 125I and 103Pd seeds. It is found that the PB prescribed doses (minimum peripheral dose) that give an equivalent EBRT dose of 64.8, 70.2, 75.6 and 81 Gy with a fraction size of 1.8 Gy are 129, 139, 150 and 161 Gy for 125I and 103, 112, 122 and 132 Gy for 103Pd implants, respectively. Estimates of the EUD and TCP for a series of possible prescribed dose levels (e.g., 145, 160, 170 and 180 Gy for 125I and 125, 135, 145 and 155 for 103Pd implants) are tabulated. The EUD calculation was found to depend strongly on DVHs and radiobiological parameters. The dosimetric calculations suggest that the dose to prostate can be escalated without a substantial increase in both rectal and urethral dose. For example, increasing the PB prescribed dose from 145 to 180 Gy increases EUD for the rectum by only 3%. Our studies indicate that the dose to urethra can be kept within 100-120% of the prescription dose for all the dose levels studied. In conclusion, dose escalation in permanent implant for localized prostate cancer may be advantageous. It is dosimetrically possible to increase dose to prostate without a substantial increase in the dose to the rectum and urethra. Based on the results of our studies, a prospective dose escalation trial for prostate permanent implants has been initiated at our institution.

Radioactive iodine-125 implantation for cancer of the prostate.

PubMed

Nag, S

1985-01-01

Localized cancer of the prostate can be treated by radical prostatectomy, external beam irradiation, or radioactive implantation with similar survival results. Radical prostatectomy, however, almost universally results in impotency, although a new, nerve-sparing procedure may preserve potency in B1 patients. External beam irradiation radiates a large volume of tissue with significant rectal and bladder morbidity, 23-47% risk of impotency, and requires prolonged treatment (6-8 weeks). Radioactive implantation may be done suprapubically or transperineally using iodine-125, gold-198, or radon-222 permanent implantation techniques and iridium-192 or radium-226 removable implantation techniques. Interstitial iodine-125 implantation is frequently employed since it is a short procedure and limits the morbidity to a 7% incidence of impotency, 20% urinary complications, and 5% rectal complications. The overall 5-year survival of patients with iodine-125 is 79%, the survival rate decreasing with increasing T or N stage or increasing grade of tumor.

Blast-Absorbing Bag

NASA Technical Reports Server (NTRS)

Kahn, Jon B.

1992-01-01

Proposed expandable bag contains debris from explosion. Permanently surrounds vessel or devices prone to explosive disintegration or slipped around small bomb. Finned cells shaped like outward-opening cups. Cells built up from overlapped sheets of fabric and stitched together to form expandable polyhedral bag. Cells pentagonal, triangular or square.

Entropy in an expanding universe.

PubMed

Frautschi, S

1982-08-13

The question of how the observed evolution of organized structures from initial chaos in the expanding universe can be reconciled with the laws of statistical mechanics is studied, with emphasis on effects of the expansion and gravity. Some major sources of entropy increase are listed. An expanding "causal" region is defined in which the entropy, though increasing, tends to fall further and further behind its maximum possible value, thus allowing for the development of order. The related questions of whether entropy will continue increasing without limit in the future, and whether such increase in the form of Hawking radiation or radiation from positronium might enable life to maintain itself permanently, are considered. Attempts to find a scheme for preserving life based on solid structures fail because events such as quantum tunneling recurrently disorganize matter on a very long but fixed time scale, whereas all energy sources slow down progressively in an expanding universe. However, there remains hope that other modes of life capable of maintaining themselves permanently can be found.

[Stent implantation in the treatment of pharynx anastomotic stenosis after cervical esophageal resection: a case report].

PubMed

Zang, Chuanshan; Sun, Jian; Sun, Yan

2016-03-01

We report the treatment of one patient with pharynx anastomotic stenosis after cervical esophagealresection by stent implantation. The patient suffered from serious pharynx anastomotic stenosis after gastric-pha-ryngeal anastomosis. After balloon-dilatation,a domestic self-expanding Z-stents was implanted in the stricture ofthe esophagus under the X-rays. After stent implantation, the patient has been leading a normal life for threeyears. Balloon dilatation and stent implantation is an effective and safe method in the treatment of patients withpharynx anastomotic stenosis.

Biodegradable Orthopedic Magnesium-Calcium (MgCa) Alloys, Processing, and Corrosion Performance.

PubMed

Salahshoor, Meisam; Guo, Yuebin

2012-01-09

Magnesium-Calcium (Mg-Ca) alloy has received considerable attention as an emerging biodegradable implant material in orthopedic fixation applications. The biodegradable Mg-Ca alloys avoid stress shielding and secondary surgery inherent with permanent metallic implant materials. They also provide sufficient mechanical strength in load carrying applications as opposed to biopolymers. However, the key issue facing a biodegradable Mg-Ca implant is the fast corrosion in the human body environment. The ability to adjust degradation rate of Mg-Ca alloys is critical for the successful development of biodegradable orthopedic implants. This paper focuses on the functions and requirements of bone implants and critical issues of current implant biomaterials. Microstructures and mechanical properties of Mg-Ca alloys, and the unique properties of novel magnesium-calcium implant materials have been reviewed. Various manufacturing techniques to process Mg-Ca based alloys have been analyzed regarding their impacts on implant performance. Corrosion performance of Mg-Ca alloys processed by different manufacturing techniques was compared. In addition, the societal and economical impacts of developing biodegradable orthopedic implants have been emphasized.

Biodegradable Orthopedic Magnesium-Calcium (MgCa) Alloys, Processing, and Corrosion Performance

PubMed Central

Salahshoor, Meisam; Guo, Yuebin

2012-01-01

Magnesium-Calcium (Mg-Ca) alloy has received considerable attention as an emerging biodegradable implant material in orthopedic fixation applications. The biodegradable Mg-Ca alloys avoid stress shielding and secondary surgery inherent with permanent metallic implant materials. They also provide sufficient mechanical strength in load carrying applications as opposed to biopolymers. However, the key issue facing a biodegradable Mg-Ca implant is the fast corrosion in the human body environment. The ability to adjust degradation rate of Mg-Ca alloys is critical for the successful development of biodegradable orthopedic implants. This paper focuses on the functions and requirements of bone implants and critical issues of current implant biomaterials. Microstructures and mechanical properties of Mg-Ca alloys, and the unique properties of novel magnesium-calcium implant materials have been reviewed. Various manufacturing techniques to process Mg-Ca based alloys have been analyzed regarding their impacts on implant performance. Corrosion performance of Mg-Ca alloys processed by different manufacturing techniques was compared. In addition, the societal and economical impacts of developing biodegradable orthopedic implants have been emphasized. PMID:28817036

Permanent right ventricular pacing through an anomalous left superior vena cava.

PubMed Central

Amikam, S; Lemer, J; Riss, E

1977-01-01

A persistent left superior vena cava can complicate the implantation of a transvenous pacemaker. In a patient who required a permanent pacemaker, this venous anomaly was discovered during the insertion of the electrode but it did not prevent long-term right ventricular pacing. This was achieved after the electrode had been manipulated through the coronary sinus and right atrium. A plan of management is proposed for dealing with this unexpected problem. Images PMID:601745

SU-E-T-546: Use of Implant Volume for Quality Assurance of Low Dose Rate Brachytherapy Treatment Plans

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

Wilkinson, D; Kolar, M

Purpose: To analyze the application of volume implant (V100) data as a method for a global check of low dose rate (LDR) brachytherapy plans. Methods: Treatment plans for 335 consecutive patients undergoing permanent seed implants for prostate cancer and for 113 patients treated with plaque therapy for ocular melanoma were analyzed. Plaques used were 54 COMS (10 to 20 mm, notched and regular) and 59 Eye Physics EP917s with variable loading. Plots of treatment time x implanted activity per unit dose versus v100 ^.667 were made. V100 values were obtained using dose volume histograms calculated by the treatment planning systemsmore » (Variseed 8.02 and Plaque Simulator 5.4). Four different physicists were involved in planning the prostate seed cases; two physicists for the eye plaques. Results: Since the time and dose for the prostate cases did not vary, a plot of implanted activity vs V100 ^.667 was made. A linear fit with no intercept had an r{sup 2} = 0.978; more than 94% of the actual activities fell within 5% of the activities calculated from the linear fit. The greatest deviations were in cases where the implant volumes were large (> 100 cc). Both COMS and EP917 plaque linear fits were good (r{sup 2} = .967 and .957); the largest deviations were seen for large volumes. Conclusions: The method outlined here is effective for checking planning consistency and quality assurance of two types of LDR brachytherapy treatment plans (temporary and permanent). A spreadsheet for the calculations enables a quick check of the plan in situations were time is short (e.g. OR-based prostate planning)« less

The Safety and efficacy of a new self-expandable intratracheal nitinol stent for the tracheal collapse in dogs

PubMed Central

Kim, Joon-young; Han, Hyun-jung; Yun, Hun-young; Lee, Bora; Jang, Ha-young; Eom, Ki-dong; Park, Hee-myung

2008-01-01

To evaluate the potential utility of a self-expandable intratracheal nitinol stent with flared ends for the treatment of tracheal collapse in dogs, endotracheal stenting therapy was performed under fluoroscopic guidance in four dogs with severe tracheal collapse. During the 4 to 7 month follow-up, after stent implantation, clinical signs, including dyspnea and respiratory distress, dramatically improved in all dogs. The radiographs showed that the implanted stents improved the tracheal collapse, and there were no side effects such as collapse, shortening or migration of the stents. In conclusion, the self-expandable intratracheal nitinol stents provided adequate stability to the trachea and were effective for attenuating the clinical signs associated with severe tracheal collapse. PMID:18296893

In vitro assessment of MRI issues at 3-Tesla for a breast tissue expander with a remote port.

PubMed

Linnemeyer, Hannah; Shellock, Frank G; Ahn, Christina Y

2014-04-01

A patient with a breast tissue expander may require a diagnostic assessment using magnetic resonance imaging (MRI). To ensure patient safety, this type of implant must undergo in vitro MRI testing using proper techniques. Therefore, this investigation evaluated MRI issues (i.e., magnetic field interactions, heating, and artifacts) at 3-Tesla for a breast tissue expander with a remote port. A breast tissue expander with a remote port (Integra Breast Tissue Expander, Model 3612-06 with Standard Remote Port, PMT Corporation, Chanhassen, MN) underwent evaluation for magnetic field interactions (translational attraction and torque), MRI-related heating, and artifacts using standardized techniques. Heating was evaluated by placing the implant in a gelled-saline-filled phantom and MRI was performed using a transmit/receive RF body coil at an MR system reported, whole body averaged specific absorption rate of 2.9-W/kg. Artifacts were characterized using T1-weighted and GRE pulse sequences. Magnetic field interactions were not substantial and, thus, will not pose a hazard to a patient in a 3-Tesla or less MRI environment. The highest temperature rise was 1.7°C, which is physiologically inconsequential. Artifacts were large in relation to the remote port and metal connector of the implant but will only present problems if the MR imaging area of interest is where these components are located. A patient with this breast tissue expander with a remote port may safely undergo MRI at 3-Tesla or less under the conditions used for this investigation. These findings are the first reported at 3-Tesla for a tissue expander. Copyright © 2014 Elsevier Inc. All rights reserved.

Intra-oral soft tissue expansion and volume stability of onlay bone grafts.

PubMed

Abrahamsson, Peter

2011-01-01

Insufficient regeneration of missing bone and soft-tissue may present aesthetic or functional problems in patients indicated for dental implant surgery. Several techniques such as bone grafts, bone substitutes and guided tissue regeneration (GTR) have been described to rebuild a compromised alveolar ridge. Adequate soft-tissue coverage of grafted bone and titanium-mesh is important to avoid exposure which may result in loss of the bone graft. The general aim of this thesis was to evaluate use of an osmotic tissue expander for expanding intra-oral soft tissue--creating a surplus of soft tissue-- in preparation for onlay bone grafting. An experimental rabbit model was used in studies (I), (II) and (III). In (I) an osmotic soft-tissue expander was placed bilaterally on the lateral wall of the mandible via an extra-oral approach. After two weeks of expansion the rabbits were killed and specimens were collected for histology. No inflammatory reaction and no resorbtion of the cortical bone occured. The periosteum was expanded and new bone formation was seen in the edges of the expander. In (II) and (III) the expander was placed under the periosteum in the same way as in (I): bilaterally in 13 rabbits in (II) and unilaterally in 11 rabbits in (III). After two weeks of expansion the expander was identified and removed. In (II) particulated bone was placed at the recipient site protected by a titanium mesh in one site and a bio-resorbable mesh on the other site. In (III), DBBM particles and bone particles collected from the lateral border of the mandible separated by a collagen membrane was placed at the recipient site. The graft was protected by a pre-bent titanium mesh covered by a collagen membrane. After a healing period of 3 months specimens were collected for histological and SEM examination. New bone was growing in direct contact with the titanium mesh and bio resorbable mesh. The newly formed bone had the same calcium content as the mature bone in the base of the mandible. In the clinical study (IV) 20 patients were consecutively recruited and randomised into two groups. The experimental group (ten patients) had an osmotic soft tissue expander implanted. After two weeks of expansion the expander was removed and a particulated bone graft protected by a titanium mesh and a collagen membrane was fixed to the recipient site. Titanium implants were installed after a healing period of 6 months. The patients in the reference group had a bone block grafted from the anterior ramus fixated to the recipient site with one or two titanium mini screws. Implants were installed after a healing period of 6 months. A three dimensional optical measuring device was used to measure alterations in the soft tissue profile before each surgical procedure. The three-dimensional changes were then analysed on a PC. The results from the clinical study in patients confirmed the results from the experimental rabbit studies. The osmotic tissue expander expanded the soft tissue. Expander perforations of the soft tissue occurred in two patients. The optical measurements demonstrated a positive volume gain after soft tissue expansion and bone grafting. The expanded tissue could be used to cover a bone graft. There still was a risk of mesh exposure, even after soft tissue expansion, which occurred in two patients. In both groups, implants could be installed in the grafted bone in positions that would allow the crowns to fit aesthetically into the dental arch.

Impella 5.0 Support in INTERMACS II Cardiogenic Shock Patients Using Right and Left Axillary Artery Access.

PubMed

Schibilsky, David; Lausberg, Henning; Haller, Christoph; Lenglinger, Matthias; Woernle, Barbara; Haeberle, Helene; Rosenberger, Peter; Walker, Tobias; Schlensak, Christian

2015-08-01

The catheter-based Impella 5.0 left ventricular assist device (LVAD) is a powerful and less invasive alternative for patients in cardiogenic shock. The use of this device as a primary mechanical circulatory support strategy in INTERMACS II patients should be evaluated. From April 2014 to August 2014, eight Impella 5.0 devices were implanted in seven patients via the axillary artery access (six right and two left). We analyzed the outcome of the four patients in whom the Impella 5.0 device was implanted for the purpose of primary stabilization of cardiogenic shock (INTERMACS II). The remaining three patients had a contraindication for a permanent LVAD and received the device for prolonged weaning from extracorporeal life support (ECLS) system. The implantation of the Impella 5.0 was technically successful in all patients and resulted in the stabilization of the clinical situation. All four patients could be bridged to a long-term device (n = 3) or to cardiac recovery (n = 1). In one patient, 2 days of ECLS support was necessary because of pump thrombosis after 31 days of Impella 5.0 support. One patient with bronchopneumonia had the Impella 5.0 exchanged from the right to the left axillary artery after 22 days of support because of the progressive loss of purge flow and the need for longer bridging to a permanent LVAD. The last patient was supported for giant-cell myocarditis for 22 days and bridged to cardiac recovery. All patients were transferred to the intensive care unit with the Impella device in place. In INTERMACS II situations, the implantation of the Impella 5.0 via the right or left axillary access allowed additional time for decision making. Early patient mobilization, including walking with the Impella device in place, optimized the conditions for either weaning or the implantation of a permanent LVAD. This novel technique of left axillary approach leads to more flexibility in the case of anatomical- or device-related contraindications to right-side access, or when the device needs to be exchanged while continuous support is necessary. Copyright © 2015 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

MR and CT image fusion for postimplant analysis in permanent prostate seed implants.

PubMed

Polo, Alfredo; Cattani, Federica; Vavassori, Andrea; Origgi, Daniela; Villa, Gaetano; Marsiglia, Hugo; Bellomi, Massimo; Tosi, Giampiero; De Cobelli, Ottavio; Orecchia, Roberto

2004-12-01

To compare the outcome of two different image-based postimplant dosimetry methods in permanent seed implantation. Between October 1999 and October 2002, 150 patients with low-risk prostate carcinoma were treated with (125)I and (103)Pd in our institution. A CT-MRI image fusion protocol was used in 21 consecutive patients treated with exclusive brachytherapy. The accuracy and reproducibility of the method was calculated, and then the CT-based dosimetry was compared with the CT-MRI-based dosimetry using the dose-volume histogram (DVH) related parameters recommended by the American Brachytherapy Society and the American Association of Physicists in Medicine. Our method for CT-MRI image fusion was accurate and reproducible (median shift <1 mm). Differences in prostate volume were found, depending on the image modality used. Quality assurance DVH-related parameters strongly depended on the image modality (CT vs. CT-MRI): V(100) = 82% vs. 88%, p < 0.05. D(90) = 96% vs. 115%, p < 0.05. Those results depend on the institutional implant technique and reflect the importance of lowering inter- and intraobserver discrepancies when outlining prostate and organs at risk for postimplant dosimetry. Computed tomography-MRI fused images allow accurate determination of prostate size, significantly improving the dosimetric evaluation based on DVH analysis. This provides a consistent method to judge a prostate seed implant's quality.

[LONG TERM FOLLOW-UP OF TRANSCATHETER SELF EXPANDABLE AORTIC VALVE IMPLANTATION].

PubMed

Chen, Shmuel; Zenios, Vicky; Gilon, Dan; Planer, David; Beeri, Ronen; Lotan, Chaim; Danenberg, Haim D

2018-03-01

Aortic stenosis is the most common significant valvular disease in the western world. These patients are treated operatively unless they are at high operative risk or inoperable. During the last decade an alternative approach has evolved - transcatheter aortic valve implantation (TAVI). This method was shown to be at least as effective and safe as the operative one. However, very little data exists on long term follow-up (5 years and above), especially regarding valve durability and patient survival. To present a long term follow-up on patients who underwent transcutaneous self-expandable aortic valve implantation in our department between the years 2008-2011. In September 2008 the first CoreValve implantation was performed in Israel at Hadassah Medical Center. All records of patients who were transplanted between 9.2008 and 10.2011 were reviewed. The function of the valve early after the procedure was compared to its function at the end of the follow-up period. A total of 38 patients (out of 71) survived at least 54 months, of them, 19 have an echocardiography examination at the end of the follow-up period. In all patients the implanted valve was found to function well at the end of the follow-up period, without significant stenosis or paravalvular leak. In fact, in approximately half of these patients, the degree of paravalvular leak decreased during the follow-up period. On long term (5 years) follow-up of patients who were implanted with the self-expandable aortic valve (CoreValve), no deterioration of the valve was observed. In fact, in approximately half of the patients, a decrease in the severity of the paravalvular leak was demonstrated.

Early failure of total hip replacements implanted at distant hospitals to reduce waiting lists.

PubMed Central

Ciampolini, Jac; Hubble, Matthew J. W.

2005-01-01

AIM: In the years 1990-1993, in an effort to reduce waiting-list time, a small number of patients were sent from Exeter to hospitals in London to undergo elective total hip replacement. No medium- or long-term follow-up was arranged. Our aim was to audit the outcome of these hip replacements. PATIENTS AND METHODS: Review of the records of the referring medical practices, Regional Health Authority, local orthopaedic hospital and the distant centres at which the surgery was performed identified 31 cases. A total of 27 hip replacements in 24 patients were available for clinical and radiological review. RESULTS: 12 (44%) hips have so far required revision surgery, at a mean of 6.5 years. Of these, three (11%) have been for deep infection. A further three hips (11%) are radiologically loose and are being closely monitored. Two patients (7%) suffered permanent sciatic nerve palsy. CONCLUSIONS: Patients whose surgery was performed locally over a similar time period have a published failure rate of only 4.9%. This difference is highly statistically significant (P < 0.001). The causes for such a difference in outcome were analysed and include surgical technique, implant selection and absence of follow-up. In the light of this evidence, we would like to urge the government to address waiting list problems by investing in the local infrastructure. Expanding those facilities where properly audited and fully accountable surgeons operate must be the way forward. PMID:15720905

Low density biodegradable shape memory polyurethane foams for embolic biomedical applications

PubMed Central

Singhal, Pooja; Small, Ward; Cosgriff-Hernandez, Elizabeth; Maitland, Duncan J; Wilson, Thomas S

2014-01-01

Low density shape memory polymer foams hold significant interest in the biomaterials community for their potential use in minimally invasive embolic biomedical applications. The unique shape memory behavior of these foams allows them to be compressed to a miniaturized form, which can be delivered to an anatomical site via a transcatheter process, and thereafter actuated to embolize the desired area. Previous work in this field has described the use of a highly covalently crosslinked polymer structure for maintaining excellent mechanical and shape memory properties at the application-specific ultra low densities. This work is aimed at further expanding the utility of these biomaterials, as implantable low density shape memory polymer foams, by introducing controlled biodegradability. A highly covalently crosslinked network structure was maintained by use of low molecular weight, symmetrical and polyfunctional hydroxyl monomers such as Polycaprolactone triol (PCL-t, Mn 900 g), N,N,N0,N0-Tetrakis (hydroxypropyl) ethylenediamine (HPED), and Tris (2-hydroxyethyl) amine (TEA). Control over the degradation rate of the materials was achieved by changing the concentration of the degradable PCL-t monomer, and by varying the material hydrophobicity. These porous SMP materials exhibit a uniform cell morphology and excellent shape recovery, along with controllable actuation temperature and degradation rate. We believe that they form a new class of low density biodegradable SMP scaffolds that can potentially be used as “smart” non-permanent implants in multiple minimally invasive biomedical applications. PMID:24090987

SU-F-T-653: Radiation Exposure from Cs-131 Permanent Seed Implants

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

Giaddui, T; Hardin, M; To, D

Purpose: Permanent seed implants have traditionally been used to treat prostate, lung and head or neck cancers using I-125 and Pd-103. Cs-131, which has higher dose rate is being used to treat brain, head and/or neck cancers in our clinic, therefore, we chose to monitor the dose received by surgeons during the extensive procedure. The aims of this work are to assess the level of radiation exposure to surgeons and the instantaneous exposure at bedside and 1 m from patients. Methods: Ten patients received Cs-131 implants for recurrent brain,head and/or neck cancer; the median implanted activity, number of implanted seedsmore » and prescription dose at 0.5 cm from the perpendicular plane of the implant were: 54.3 mCi (14.52 – 77); 19 (4 – 24) and 60 Gy (range 42 – 60) respectively. Radiation exposure was recorded at bedside and 1 m from the patient using Victoreen ion chamber (Fluke Biomedical, Cleveland, OH). Exposure to surgeons was measured using TLD (Mirion Technologies (GDS), Inc., USA). Results: The median equivalent dose rate at 1 m and bedside immediately following implantation were 1.49×10-2 mSv/h (8.77×10-3–2.63×10-2) and 7.76×10-2 mSv/h (3.1×10-2– 1.53×10-1) respectively. Median equivalent dose to surgeons’ hands was 0.60 mSv (0.33 – 1.48) and no doses were detected for whole-body. Surgical reconstruction for one patient was performed 71 days post-implant and resulted in zero exposure to surgeons. Conclusion: The recorded exposure rates were low when compared with the literature. Post procedure surveys at bed site and 1 m indicated that all patients were within safe limits for discharge (< 0.05 mSv/h at 1 m). However, as a precautionary measure, patients were advised to avoid direct contact with children and pregnant women within four weeks of the implant and stay at least at 3 ft from other people. Surgeons doses were well within occupational dose limits.« less

Current trends in dental implants

PubMed Central

Gaviria, Laura; Salcido, John Paul; Guda, Teja

2014-01-01

Tooth loss is very a very common problem; therefore, the use of dental implants is also a common practice. Although research on dental implant designs, materials and techniques has increased in the past few years and is expected to expand in the future, there is still a lot of work involved in the use of better biomaterials, implant design, surface modification and functionalization of surfaces to improve the long-term outcomes of the treatment. This paper provides a brief history and evolution of dental implants. It also describes the types of implants that have been developed, and the parameters that are presently used in the design of dental implants. Finally, it describes the trends that are employed to improve dental implant surfaces, and current technologies used for the analysis and design of the implants. PMID:24868501

Brachytherapy optimization using radiobiological-based planning for high dose rate and permanent implants for prostate cancer treatment

NASA Astrophysics Data System (ADS)

Seeley, Kaelyn; Cunha, J. Adam; Hong, Tae Min

2017-01-01

We discuss an improvement in brachytherapy--a prostate cancer treatment method that directly places radioactive seeds inside target cancerous regions--by optimizing the current standard for delivering dose. Currently, the seeds' spatiotemporal placement is determined by optimizing the dose based on a set of physical, user-defined constraints. One particular approach is the ``inverse planning'' algorithms that allow for tightly fit isodose lines around the target volumes in order to reduce dose to the patient's organs at risk. However, these dose distributions are typically computed assuming the same biological response to radiation for different types of tissues. In our work, we consider radiobiological parameters to account for the differences in the individual sensitivities and responses to radiation for tissues surrounding the target. Among the benefits are a more accurate toxicity rate and more coverage to target regions for planning high-dose-rate treatments as well as permanent implants.

Automated seed localization from CT datasets of the prostate.

PubMed

Brinkmann, D H; Kline, R W

1998-09-01

With the increasing utilization of permanent brachytherapy implants for treating carcinoma of the prostate, the importance of accurate post-treatment dose calculation also increases for assessing patient outcome and planning future treatments. An automatic method for seed localization of permanent brachytherapy implants, using CT datasets of the prostate, has been developed and tested on a phantom using an actual patient planned seed distribution. This method was also compared to results with the three-film technique for three patient datasets. The automatic method is as accurate or more accurate than the three film technique for 1 mm, 3 mm, and 5 mm contiguous CT slices, and eliminates the inter- and intra-observer variability of the manual methods. The automated method improves the localization of brachytherapy seeds while reducing the time required for the user to input information, and is demonstrated to be less operator dependent, less time consuming, and potentially more accurate than the three-film technique.

Implant-based oral rehabilitation of a variant model of type I dentinal dysplasia: A rare case report

PubMed Central

Nettem, Sowmya; Nettemu, Sunil Kumar; Basha, K.; Venkatachalapathi, S

2014-01-01

Dentin dysplasia is an exceptionally rare, autosomal-dominant, hereditary condition, primarily characterized by defective dentin formation affecting both the deciduous and permanent dentitions. The etiology remains imprecise to date, in spite of the numerous hypotheses put forward and the constant updates on this condition. This case report of type I dentin dysplasia exhibits radiographic findings that are unique and diverse from the classical findings of various subtypes of this disease reported to date. This article also depicts the implant-based oral rehabilitation of the young patient diagnosed with this variant model of dentin dysplasia type I. Early diagnosis and implementation of this preventive and curative therapy is vital for avoiding premature exfoliation of deciduous and permanent dentition and the associated residual ridge resorption, thereby overcoming functional and esthetic deficits and ensuring protection of the remaining dentition from further harm. PMID:25225567

Expanding the Adoption on Private Lands : Blowing-and-Drifting Snow Control Treatments and the Cost Effectiveness of Permanent versus Non-Permanent Treatment Options

DOT National Transportation Integrated Search

2017-11-01

Previous research that estimated the costs and benefits of snow-fences for MnDOT in terms of a reduction in the costs of mitigating blowing-and-drifting snow problem areas (MN/RC 2012-03) demonstrated the ability of snow-fences to significantly lower...

Development of a novel anisotropic self-inflating tissue expander: in vivo submucoperiosteal performance in the porcine hard palate.

PubMed

Swan, Marc C; Bucknall, David G; Czernuszka, Jan T; Pigott, David W; Goodacre, Timothy E E

2012-01-01

The advent of self-inflating hydrogel tissue expanders heralded a significant advance in the reconstructive potential of this technique. Their use, however, is limited by their uncontrolled isotropic (i.e., uniform in all directions) expansion. Anisotropy (i.e., directional dependence) was achieved by annealing a hydrogel copolymer of poly(methyl methacrylate-co-vinyl pyrrolidone) under a compressive load for a specified time period. The expansion ratio is dictated by the percentage of vinyl pyrrolidone content and the degree of compression. The expansion rate is modified by incorporating the polymer within a silicone membrane. The in vivo efficacy of differing prototype devices was investigated in juvenile pigs under United Kingdom Home Office Licence. The devices were implanted within a submucoperiosteal pocket in a total of six porcine palates; all were euthanized by 6 weeks after implantation. A longitudinal volumetric assessment of the expanded tissue was conducted, in addition to postmortem analysis of the bony and mucoperiosteal palatal elements. Uncoated devices caused excessive soft-tissue expansion that resulted in mucoperiosteal ulceration, thus necessitating animal euthanasia. The silicone-coated devices produced controlled soft-tissue expansion over the 6-week study period. There was a statistically significant increase in the volume of expanded soft tissue with no evidence of a significant acute inflammatory response to the implant, although peri-implant capsule formation was observed. Attenuation of the bony palatal shelf was noted. A unique anisotropic hydrogel device capable of controlled expansion has been developed that addresses a number of the shortcomings of the technology hitherto available.

Condyle-fossa modifications and muscle interactions during herbst treatment, part 1. New technological methods.

PubMed

Voudouris, John C; Woodside, Donald G; Altuna, Gurkan; Kuftinec, Mladen M; Angelopoulos, Gerassimos; Bourque, Paul J

2003-06-01

Changes in the condyle, the glenoid fossa, and the muscles of mastication were investigated in subjects undergoing continuous orthopedic advancement of the mandible with a Herbst-block appliance. The total sample consisted of 56 subjects and included 15 nonhuman primates (in the middle mixed, early permanent, and permanent dentitions), 17 human Herbst patients in the early permanent dentition, and 24 human controls from the Burlington Growth Center. The 8 nonhuman primates in the middle mixed dentition were the focus of this study. Mandibular advancement was obtained progressively in 5 animals by adding stops to the telescopic arms of fixed functional Herbst appliances with occlusal coverage; activations of 5.0 mm, 7.0 mm, and 8.0 mm were achieved. Two primates served as controls, and the third was a sham control. Two experimental animals and the 2 controls also wore surgically implanted electromyographic electrodes in the superior and inferior heads of the lateral pterygoid muscles and in the superficial masseter and anterior digastric muscles. Changes in condylar growth direction and amount were assessed with the Björk method from measurements made on serial cephalometric tracings superimposed on metallic implants. Undecalcified sections, treated with intravenous tetracycline vital staining, were viewed with fluorescence microscopy to examine histologic changes in the condyle and the glenoid fossa. New bone formation in the fossa associated with continuous mandibular protrusion was quantified by using computerized histomorphometric analysis of decalcified histological sections and polarized light. The unique combination of permanently implanted electromyographic electrodes, tetracycline vital staining, and histomorphometry represents a significant technological advancement in methods and materials. Together, they demonstrated different muscle-bone interaction results for functional appliances than those reported in previous studies. In Part 1 of this study, we describe and discuss the techniques used in this research and give a brief overview of the findings; in Part 2 (to be published next month), we offer a more in-depth discussion of the results and the implications of our findings.

Long-term survival after ablation of the atrioventricular node and implantation of a permanent pacemaker in patients with atrial fibrillation.

PubMed

Ozcan, C; Jahangir, A; Friedman, P A; Patel, P J; Munger, T M; Rea, R F; Lloyd, M A; Packer, D L; Hodge, D O; Gersh, B J; Hammill, S C; Shen, W K

2001-04-05

In patients with atrial fibrillation that is refractory to drug therapy, radio-frequency ablation of the atrioventricular node and implantation of a permanent pacemaker are an alternative therapeutic approach. The effect of this procedure on long-term survival is unknown. We studied all patients who underwent ablation of the atrioventricular node and implantation of a permanent pacemaker at the Mayo Clinic between 1990 and 1998. Observed survival was compared with the survival rates in two control populations: age- and sex-matched members of the Minnesota population between 1970 and 1990 and consecutive patients with atrial fibrillation who received drug therapy in 1993. A total of 350 patients (mean [+/-SD] age, 68+/-11 years) were studied. During a mean of 36+/-26 months of follow-up, 78 patients died. The observed survival rate was significantly lower than the expected survival rate based on the general Minnesota population (P<0.001). Previous myocardial infarction (P<0.001), a history of congestive heart failure (P=0.02), and treatment with cardiac drugs after ablation (P=0.03) were independent predictors of death. Observed survival among patients without these three risk factors was similar to expected survival (P=0.43). None of the 26 patients with lone atrial fibrillation died during follow-up (37+/-27 months). The observed survival rate among patients who underwent ablation was similar to that among 229 controls with atrial fibrillation (mean age, 67+/-12 years) who received drug therapy (P=0.44). In the absence of underlying heart disease, survival among patients with atrial fibrillation after ablation of the atrioventricular node is similar to expected survival in the general population. Long-term survival is similar for patients with atrial fibrillation, whether they receive ablation or drug therapy. Control of the ventricular rate by ablation of the atrioventricular node and permanent pacing does not adversely affect long-term survival.

Electrocardiographic Predictors of Long-Term Cardiac Pacing Dependency Following Transcatheter Aortic Valve Implantation.

PubMed

Naveh, Sivan; Perlman, Gidon Y; Elitsur, Yair; Planer, David; Gilon, Dan; Leibowitz, David; Lotan, Chaim; Danenberg, Haim; Alcalai, Ronny

2017-02-01

Conduction disorders requiring permanent pacemaker (PPM) implantation are a known complication of transcatheter aortic valve implantation (TAVI). Indications for permanent pacing in this setting are still controversial. The study aim was to characterize the natural history of conduction disorders related to TAVI, and to identify predictors for long-term pacing dependency. Consecutive patients who underwent TAVI were included in this prospective observational study. The conduction system was investigated by reviewing 12-lead ECGs during hospitalization and up to 1-year follow-up and by analyzing pacemaker interrogation data. Multivariate analysis was performed in order to identify independent predictors for pacemaker dependency. Of 110 patients included in the analysis, 38 (34.5%) underwent PPM implantation. Of those, 26 (68.4%) had a long-term pacing dependency (required PPM), while 12 (31.6%) did not (not-required PPM). Logistic regression revealed that baseline RBBB (P = 0.01, OR = 18.0), baseline PR interval (P = 0.019, OR = 1.14), post-TAVI PR interval and the change in PR interval from baseline (P < 0.001 for both, OR = 1.17 for each 10 milliseconds increment) were independent predictors for long-term pacing dependency. A PR interval increment of greater than 28 milliseconds had the best accuracy in predicting pacemaker dependency. Increased pre- and postprocedural PR intervals and pre-existing RBBB are reliable predictors for long-term PPM dependency, while left bundle branch block or QRS width are misleading factors. Our study suggests that the decision for implanting PPM after TAVI should be based mostly on the prolongation of the PR interval. © 2016 Wiley Periodicals, Inc.

New-Onset Left Bundle Branch Block Induced by Transcutaneous Aortic Valve Implantation.

PubMed

Massoullié, Grégoire; Bordachar, Pierre; Ellenbogen, Kenneth A; Souteyrand, Géraud; Jean, Frédéric; Combaret, Nicolas; Vorilhon, Charles; Clerfond, Guillaume; Farhat, Mehdi; Ritter, Philippe; Citron, Bernard; Lusson, Jean-R; Motreff, Pascal; Ploux, Sylvain; Eschalier, Romain

2016-03-01

New-onset left bundle branch block (LBBB) is a specific concern of transcutaneous aortic valve implantation (TAVI) given its estimated incidence ranging from 5% to 65%. This high rate of occurrence is dependent on the type of device used (size and shape), implantation methods, and patient co-morbidities. The appearance of an LBBB after TAVI reflects a very proximal lesion of the left bundle branch as it exits the bundle of His. At times transient, its persistence can lead to permanent pacemaker implantation in 15% to 20% of cases, most often for high-degree atrioventricular block. The management of LBBB after TAVI is currently not defined by international societies resulting in individual centers developing their own management strategy. The potential consequences of LBBB are dysrhythmias (atrioventricular block, syncope, and sudden death) and functional (heart failure) complications. Prompt postprocedural recognition and management (permanent pacemaker implantation) of patients prevents the occurrence of potential complications and may constitute the preferred approach in this frail and elderly population despite additional costs and complications of cardiac pacing. Moreover, the expansion of future indications for TAVI necessitates better identification of the predictive factors for the development of LBBB. Indeed, long-term right ventricular pacing may potentially increase the risk of developing heart failure in this population. In conclusion, it is thus imperative to not only develop new aortic prostheses with a less-deleterious impact on the conduction system but also to prescribe appropriate pacing modes in this frail population. Copyright © 2016 Elsevier Inc. All rights reserved.

Favorable toxicity and biochemical control using real-time inverse optimization technique for prostate brachytherapy.

PubMed

Raben, Adam; Rusthoven, Kyle E; Sarkar, Abrihup; Glick, Andrew; Benge, Bruce; Jacobs, Dayee; Raben, David

2009-01-01

Favorable dosimetric results have been reported using intraoperative inverse optimization (IO) for permanent prostate brachytherapy. The clinical implications of these improvements in dosimetry are unclear. We review toxicity and early biochemical outcomes for patients implanted using IO technique. Between 2001 and 2007, 165 patients received permanent prostate implants using real-time IO and had >/=3 months of followup. Dose constraints for inverse planning were: the prostate volume receiving 100% of the prescription dose [prostate V(100)] was >95%; the dose received by 90% of the gland [prostate D(90)] was within the 140-180 by dose range; the volume of urethra receiving 150% of the prescription dose [urethra V(150)] was <30%; and the volume of rectal wall receiving 110% of the prescription dose [rectal V(110)] was <1.0 cc. Toxicity was prospectively scored using the Radiation Therapy Oncology Group toxicity scale and the International Prostate Symptom Score questionnaire. Biochemical control was determined using the nadir + 2 ng/mL definition. Mean followup was 30 months (range, 6-63 months). Risk classification was low risk in 89% and intermediate risk in 11%. Iodine-125 sources were used for 161 implants and palladium-103 sources for four implants. The median number of seeds and total activity implanted were 61 and 999 MBq, respectively, for a median prostate volume of 33.6 cc. Late GU and GI morbidity was uncommon. Among patients with at least 24 months followup, 16% had persistent Grade 2-3 urinary morbidity. Grade 2 rectal bleeding occurred in 1 patient (0.6%). Biochemical failure has occurred in only 4 patients at last followup. IO technique for prostate brachytherapy is associated with low rates of late morbidity and excellent early biochemical control. Additionally, the number of seeds and total implanted activity required to achieve a high-quality implant are lower compared with historical controls.

A Meta-Analysis Examining Differences in Short-Term Outcomes Between Sutureless and Conventional Aortic Valve Prostheses.

PubMed

Hurley, Eoghan T; O'Sullivan, Katie E; Segurado, Ricardo; Hurley, John P

2015-01-01

Sutureless aortic valve prostheses are anchored by radial force in a mechanism similar to that of transcatheter aortic valve implantation. Transcatheter aortic valve implantation is associated with an increased permanent pacemaker (PPM) requirement in a significant proportion of patients. We undertook a meta-analysis to examine the incidence of PPM insertion associated with sutureless compared with conventional surgical aortic valve replacement. A systematic review was conducted in accordance with the Prisma guidelines. All searches were performed on August 10, 2014. Studies between 2007 and 2014 were included in the search. A total of 832 patients were included in the sutureless group and 3,740 in the conventional group. Aortic cross-clamp (39.8 vs 62.4 minutes; P < 0.001) and cardiopulmonary bypass (64.9 vs 86.7 minutes; P = 0.002) times were shorter in the sutureless group. Permanent pacemaker implantation rate was higher in the sutureless cohort (9.1% vs 2.4%; P = 0.025). Sutureless aortic valve prostheses are associated with significantly shorter cardiopulmonary bypass and aortic cross-clamp times and a higher incidence of PPM insertion than conventional. Further investigation of the prognostic significance is required.

Development of virtual patient models for permanent implant brachytherapy Monte Carlo dose calculations: interdependence of CT image artifact mitigation and tissue assignment.

PubMed

Miksys, N; Xu, C; Beaulieu, L; Thomson, R M

2015-08-07

This work investigates and compares CT image metallic artifact reduction (MAR) methods and tissue assignment schemes (TAS) for the development of virtual patient models for permanent implant brachytherapy Monte Carlo (MC) dose calculations. Four MAR techniques are investigated to mitigate seed artifacts from post-implant CT images of a homogeneous phantom and eight prostate patients: a raw sinogram approach using the original CT scanner data and three methods (simple threshold replacement (STR), 3D median filter, and virtual sinogram) requiring only the reconstructed CT image. Virtual patient models are developed using six TAS ranging from the AAPM-ESTRO-ABG TG-186 basic approach of assigning uniform density tissues (resulting in a model not dependent on MAR) to more complex models assigning prostate, calcification, and mixtures of prostate and calcification using CT-derived densities. The EGSnrc user-code BrachyDose is employed to calculate dose distributions. All four MAR methods eliminate bright seed spot artifacts, and the image-based methods provide comparable mitigation of artifacts compared with the raw sinogram approach. However, each MAR technique has limitations: STR is unable to mitigate low CT number artifacts, the median filter blurs the image which challenges the preservation of tissue heterogeneities, and both sinogram approaches introduce new streaks. Large local dose differences are generally due to differences in voxel tissue-type rather than mass density. The largest differences in target dose metrics (D90, V100, V150), over 50% lower compared to the other models, are when uncorrected CT images are used with TAS that consider calcifications. Metrics found using models which include calcifications are generally a few percent lower than prostate-only models. Generally, metrics from any MAR method and any TAS which considers calcifications agree within 6%. Overall, the studied MAR methods and TAS show promise for further retrospective MC dose calculation studies for various permanent implant brachytherapy treatments.

Evaluation of Death among the Patients Undergoing Permanent Pacemaker Implantation: A Competing Risks Analysis

PubMed Central

GHAEM, Haleh; GHORBANI, Mohammad; ZARE DORNIANI, Samira

2017-01-01

Background: Permanent artificial pacemaker is one of the important therapies for treatment of cardiac conduction system problems. The present study aimed to determine the association between some predictive variables and all-cause and cause-specific mortality in the patients who had undergone pacemaker implantation. Methods: This study was conducted on 1207 patients who had undergone permanent pacemaker implantation in the hospitals affiliated with Shiraz University of Medical Sciences, Iran, from Mar 2002 to Mar 2012. The variables that existed in the patients’ medical records included sex, diabetes mellitus, obesity, cerebrovascular accident, cardiomegaly, smoking, hypertension, ischemic heart disease, congenital heart disease, sick sinus syndrome, and atrial fibrillation. Competing risks model was used to assess the association between the predictive variables and cause-specific (i.e., cardiac and vascular) mortality. Results: The patients’ mean age was 66.32±17.92 yr (70.62±14.45 yr in the patients with single-chamber pacemakers vs. 61.91±17.69 yr in those with two-chamber pacemakers) (P<0.001). Sick sinus syndrome and age increased the risk of all-cause mortality, while two-chamber pacemaker decreased this risk. Obesity increased the risk of cardiac death, and diabetes mellitus and heart valve disease increased the risk of vascular death. Conclusion: The variables predicting mortality in all-cause model were completely different from those in cause-specific model. Moreover, death in such patients may occur due to reasons other than pacemaker. Therefore, future studies, particularly prospective ones, are recommended to use competing risks models. PMID:28828325

Closure of oroantral communication with buccal fat pad after removing bilateral failed zygomatic implants: A case report and 6-month follow-up.

PubMed

Peñarrocha-Oltra, David; Alonso-González, Rocio; Pellicer-Chover, Hilario; Aloy-Prósper, Amparo; Peñarrocha-Diago, María

2015-02-01

The aim of this study was to assess the use of buccal fat pad (BFP) technique as an option to close oroantral communications (OAC) after removing failed zygomatic implants in a patient with a severely resorbed maxilla, and to determine the degree of patient satisfaction. A 64-year-old woman presented recurrent sinusitis and permanent oroantral communication caused by bilateral failed zygomatic implants, 3 years after prosthetic loading. Zygomatic implants were removed previous antibiotic treatment and the BFP flap technique was used to treat the OAC and maxillary defect. The degree of patient satisfaction after treatment was assessed through a visual analogue scale (VAS). At 6-months follow-up, patient showed complete healing and good function and the results in terms of phonetics, aesthetics and chewing were highly rated by the patient. Key words:Bichat fat pad, buccal fat pad, zygomatic implants, oroantral communication.

[Sudden cardiac death in the youth. Is the new subcutaneous implantable cardioverter defibrillator S-ICD an alternative solution?].

PubMed

Roche, N-C; Stefuriac, M; Dumitrescu, N; Charbonnel, A; Godreuil, C; Bonnevie, L

2015-02-01

Implantable cardioverter defibrillator (ICD) is well-recognized therapy to prevent sudden cardiac death. Classic ICD need the use of permanent endocavitary leads, which may cause serious troubles (lead dislodgement, ventricular perforation, lead infections, etc.). The subcutaneous implantable cardioverter defibrillator (S-ICD) is a new device provided by only a subcutaneous lead. It has been developed for the last five years and it is becoming at present a real alternative to classic ICD. We report a clinical case of a 34 y.o. woman who presented a sudden cardiac death and who benefited the implantation of this new technology. This paper deals with the potential indications, usefulness benefits, and problems of the S-ICD. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Implantable medical sensor system

DOEpatents

Darrow, Christopher B.; Satcher, Jr., Joe H.; Lane, Stephen M.; Lee, Abraham P.; Wang, Amy W.

2001-01-01

An implantable chemical sensor system for medical applications is described which permits selective recognition of an analyte using an expandable biocompatible sensor, such as a polymer, that undergoes a dimensional change in the presence of the analyte. The expandable polymer is incorporated into an electronic circuit component that changes its properties (e.g., frequency) when the polymer changes dimension. As the circuit changes its characteristics, an external interrogator transmits a signal transdermally to the transducer, and the concentration of the analyte is determined from the measured changes in the circuit. This invention may be used for minimally invasive monitoring of blood glucose levels in diabetic patients.

Expansion of Mandibular Knife-Edge Ridge and Simultaneous Implant Placement to Retain Overdentures: One-Year Clinical and Radiographic Results of a Prospective Study.

PubMed

ELsyad, Moustafa Abdou; Hammouda, Nelly Ibrahim

2017-02-01

The aim of this study was to evaluate and compare the clinical and radiographic outcomes of two implants placed in expanded mandibular knife-edge ridge and implants placed in unexpanded ridges to retain overdentures. Fifteen completely edentulous patients with knife-edge ridges at canine areas of the mandible received two implants using the ridge expansion technique (study group, SG). Expansion was performed using piezoelectric corticotomy, and self-threading expanders. The control group (CG) comprised patients who received two-implant at canine areas without ridge expansion but were all case matched to SG and served as historical cohort. In both groups, mandibular overdentures were connected to the implants with Locator attachments 3 months after implant placement. Clinical (Plaque index; PI, Gingival index; GI, Probing depth; PD, and implant stability; ISQ) and radiographic (Vertical bone loss; VBL) parameters were recorded at time of overdenture insertion (base line, T0), 6 months (T6), and 12 months (T12) after insertion. The cumulative success rates were 100% and 96.4% for CG and SG, respectively, without significant difference between groups. All tested parameters increased significantly with advance of time in both groups. There was no significant difference in PI, GI, PD, and ISQ between groups. However, SG recorded significant higher VBL than CG at T6 and T12. Expansion of mandibular knife edge ridge and simultaneous placement of implants to retain overdentures is associated with clinic and radiographic outcomes comparable to implants placed in unexpanded ridges after 1 year. However, long term randomized controlled trials with sufficient sample size are still needed to ensure the findings of the present study. © 2016 Wiley Periodicals, Inc.

The efficacy of maxillary protraction protocols with the micro-implant-assisted rapid palatal expander (MARPE) and the novel N2 mini-implant-a finite element study.

PubMed

Moon, Won; Wu, Kimberley W; MacGinnis, Matthew; Sung, Jay; Chu, Howard; Youssef, George; Machado, Andre

2015-01-01

Maxillary protraction with the novel N2 mini-implant- and micro-implant-assisted rapid palatal expander (MARPE) can potentially provide significant skeletal effects without surgery, even in older patients where conventional facemask therapy has limited skeletal effects. However, the skeletal effects of altering the location and direction of force from mini-implant-assisted maxillary protraction have not been extensively analyzed. In this study, the application of the novel N2 mini-implant as an orthopedic anchorage device is explored in its ability to treat patients with class III malocclusions. A 3D cranial mesh model with associated sutures was developed from CT images and Mimics modeling software. Utilizing ANSYS simulation software, protraction forces were applied at different locations and directions to simulate conventional facemask therapy and seven maxillary protraction protocols utilizing the novel N2 mini-implant. Stress distribution and displacement were analyzed. Video animations and superimpositions were created. By changing the vector of force and location of N2 mini-implant, the maxilla was displaced differentially. Varying degrees of forward, downward, and rotational movements were observed in each case. For brachyfacial patients, anterior micro-implant-supported protraction at -45° or intermaxillary class III elastics at -45° are recommended. For dolicofacial patients, either anterior micro-implants at -15° or an intermaxillary spring at +30° is recommended. For mesofacial patients with favorable vertical maxillary position, palatal micro-implants at -30° are recommended; anterior micro-implants at -30° are preferred for shallow bites. For patients with a severe mid-facial deficiency, intermaxillary class III elastics at -30° are most effective in promoting anterior growth of the maxilla. By varying the location of N2 mini-implants and vector of class III mechanics, clinicians can differentially alter the magnitude of forward, downward, and rotational movement of the maxilla. As a result, treatment protocol can be customized for each unique class III patient.

Aqueous shunt implantation in glaucoma

PubMed Central

Wang, Jing; Barton, Keith

2017-01-01

Aqueous shunts or glaucoma drainage devices are increasingly utilized in the management of refractory glaucoma. The general design of the most commonly-used shunts is based on the principles of the Molteno implant: ie. a permanent sclerostomy (tube), a predetermined bleb area (plate) and diversion of aqueous humour to the equatorial region and away from the limbal subconjunctival space. These three factors make aqueous shunts more resistant to scarring as compared to trabeculectomy. The two most commonly used shunts are the Ahmed Glaucoma Valve, which contains a flow-restrictor, and the non-valved Baervedlt Glaucoma Implant. While the valved implants have a lower tendency to hypotony and related complications, the non-valved implants with larger, more-biocompatible end plate design, achieve lower intraocular pressures with less encapsulation. Non-valved implants require additional suturing techniques to prevent early hypotony and a number of these methods will be described. Although serious shunt-related infection is rare, corneal decompensation and diplopia are small but significant risks. PMID:29034151

Defect-mediated resonance shift of silicon-on-insulator racetrack resonators.

PubMed

Ackert, J J; Doylend, J K; Logan, D F; Jessop, P E; Vafaei, R; Chrostowski, L; Knights, A P

2011-06-20

We present a study on the effects of inert ion implantation of Silicon-On-Insulator (SOI) racetrack resonators. Selective ion implantation was used to create deep-level defects within a portion of the resonator. The resonant wavelength and round-trip loss were deduced for a range of sequential post-implantation annealing temperatures from 100 to 300 °C. As the devices were annealed there was a concomitant change in the resonance wavelength, consistent with an increase in refractive index following implantation and recovery toward the pre-implanted value. A total shift in resonance wavelength of ~2.9 nm was achieved, equivalent to a 0.02 increase in refractive index. The excess loss upon implantation increased to 301 dB/cm and was reduced to 35 dB/cm following thermal annealing. In addition to providing valuable data for those incorporating defects within resonant structures, we suggest that these results present a method for permanent tuning (or trimming) of ring resonator characteristics.

Clinical evaluation of immediate loading of titanium orthodontic implants

PubMed Central

Chopra, S.S.; Chakranarayan, A.

2015-01-01

Background Skeletal anchorage using dental implants, miniplates, miniscrews and microscrews provides an absolute anchorage for tooth movement. Miniscrew and microscrew implants have many benefits such as ease of placement and removal and immediate orthodontic force application. Methods Fifteen subjects in the permanent dentition with an overjet ≥6 mm received treatment with the 0.018-inch pre-adjusted edgewise appliance system (Roth prescription) and extraction of all first premolars. Titanium orthodontic implants were placed in both the upper quadrants and were immediately loaded with elastic chain from the implant head to the sectional arch wire. Result The overall success rate of immediate loaded titanium orthodontic micro implants (OMI) in the present study was 83.33%, with a mean chairside time of 15.33 min of placing two implants in each patient. Peri-implant inflammation was the only complication observed. Most failures were in the initial part of the study. There was no significant difference in the success rate of implants based on sex, side of placement (right or left) and type of malocclusion. Conclusion The OMIs used in the present study proved to be effective and well tolerated in producing immediate orthodontic anchorage for the retraction. PMID:25859080

Atrial electrogram quality in single-pass defibrillator leads with floating atrial bipole in patients with permanent atrial fibrillation and cardiac resynchronization therapy.

PubMed

Sticherling, Christian; Müller, Dirk; Schaer, Beat A; Krüger, Silke; Kolb, Christof

2018-03-27

Many patients receiving cardiac resynchronization therapy (CRT) suffer from permanent atrial fibrillation (AF). Knowledge of the atrial rhythm is important to direct pharmacological or interventional treatment as well as maintaining AV-synchronous biventricular pacing if sinus rhythm can be restored. A single pass single-coil defibrillator lead with a floating atrial bipole has been shown to obtain reliable information about the atrial rhythm but has never been employed in a CRT-system. The purpose of this study was to assess the feasibility of implanting a single coil right ventricular ICD lead with a floating atrial bipole and the signal quality of atrial electrograms (AEGM) in CRT-defibrillator recipients with permanent AF. Seventeen patients (16 males, mean age 73 ± 6 years, mean EF 25 ± 5%) with permanent AF and an indication for CRT-defibrillator placement were implanted with a designated CRT-D system comprising a single pass defibrillator lead with a atrial floating bipole. They were followed-up for 103 ± 22 days using remote monitoring for AEGM transmission. All patients had at last one AEGM suitable for atrial rhythm diagnosis and of 100 AEGM 99% were suitable for visual atrial rhythm assessment. Four patients were discharged in sinus rhythm and one reverted to AF during follow-up. Atrial electrograms retrieved from a single-pass defibrillator lead with a floating atrial bipole can be reliably used for atrial rhythm diagnosis in CRT recipients with permanent AF. Hence, a single pass ventricular defibrillator lead with a floating bipole can be considered in this population. Copyright © 2018 Indian Heart Rhythm Society. Production and hosting by Elsevier B.V. All rights reserved.

Sequential transcatheter aortic valve implantation due to valve dislodgement - a Portico valve implanted over a CoreValve bioprosthesis.

PubMed

Campante Teles, Rui; Costa, Cátia; Almeida, Manuel; Brito, João; Sondergaard, Lars; Neves, José P; Abecasis, João; M Gabriel, Henrique

2017-03-01

Transcatheter aortic valve implantation (TAVI) has become an important treatment in high surgical risk patients with severe aortic stenosis (AS), whose complications need to be managed promptly. The authors report the case of an 86-year-old woman presenting with severe symptomatic AS, rejected for surgery due to advanced age and comorbidities. The patient underwent a first TAVI, with implantation of a Medtronic CoreValve ® , which became dislodged and migrated to the ascending aorta. Due to the previous balloon valvuloplasty, the patient's AS became moderate, and her symptoms improved. After several months, she required another intervention, performed with a St. Jude Portico ® repositionable self-expanding transcatheter aortic valve. There was a good clinical response that was maintained at one-year follow-up. The use of a self-expanding transcatheter bioprosthesis with repositioning features is a solution in cases of valve dislocation to avoid suboptimal positioning of a second implant, especially when the two valves have to be positioned overlapping or partially overlapping each other. Copyright © 2017 Sociedade Portuguesa de Cardiologia. Publicado por Elsevier España, S.L.U. All rights reserved.

Recent progress in developing durable and permanent impeller pump.

PubMed

Qian, K X; Zeng, P; Ru, W M; Yuan, H Y

2002-04-01

Since 1980s, the author's impeller pump has successively achieved the device implantability, blood compatibility and flow pulsatility. In order to realize a performance durability, the author has concentrated in past years on solving the bearing problems of the impeller pump. Recent progress has been obtained in developing durable and permanent impeller blood pumps. At first, a durable impeller pump with rolling bearing and purge system has been developed, in which the wear-less rollers made of super-high-molecular weight polythene make the pump to work for years without mechanical wear; and the purge system enables the bearing to work in saline and heparin, and no thrombus therefore could be formed. Secondly, a durable centrifugal pump with rolling bearing and axially reciprocating impeller has been developed, the axial reciprocation of rotating impeller makes the fresh blood in and out of the bearing and to wash the rollers once a circle; in such way, no thrombus could be formed and no fluid infusion is necessary, which may bring inconvenience and discomfort to the receptors. Finally, a permanent maglev impeller pump has been developed, its rotor is suspended and floating in the blood under the action of permanent magnetic force and nonmagnetic forces, without need for position measurement and feed-back control. In conclusion, an implantable, pulsatile, and blood compatible impeller pump with durability may have more extensive applications than ever before and could replace the donor heart for transplantation in the future.

Will permanent LVADs be better than heart transplantation?

PubMed

Massad, M G; McCarthy, P M

1997-04-01

Current interest in permanent mechanical support systems has been renewed as a result of the present shortage of human heart donors, and in view of the satisfactory results obtained with their use as a bridge-to-transplant. As the number of donors is unlikely to increase dramatically in the near future, there is an urgent need to develop mechanical alternatives to transplantation. Preliminary data on the use of the implantable electric LVAD as a bridge-to-transplant indicate that the adverse clinical and mechanical events in outpatients are few and do not preclude use of the device on a permanent basis. Except for infections, transplant issues relating to need for endomyocardial biopsies, rejection, malignancies, and graft arteriosclerosis do not apply to LVAD recipients who face important issues relating to device durability, cost, and potential need for concomitant right heart support. This lack of data on long-term durability contrasts with a yearly mortality rate of about 5% after the first year of transplant. With the initiation of clinical trials on the permanent use of the electric LVAD, several design modifications and upgrading of the currently available devices are expected. Completely sealed systems with steadily improving durability will hopefully appear. Inductive coupling techniques under investigation and development appear to be able to transmit energy without damage across the skin. It is anticipated that with more reliable electronic microprocessors, the future generation of implantable LVADs will be smaller, more reliable and longer lasting.

14 CFR 67.111 - Cardiovascular.

Code of Federal Regulations, 2011 CFR

2011-01-01

... diagnosis of any of the following: (1) Myocardial infarction; (2) Angina pectoris; (3) Coronary heart disease that has required treatment or, if untreated, that has been symptomatic or clinically significant; (4) Cardiac valve replacement; (5) Permanent cardiac pacemaker implantation; or (6) Heart replacement...

14 CFR 67.311 - Cardiovascular.

Code of Federal Regulations, 2014 CFR

2014-01-01

... diagnosis of any of the following: (a) Myocardial infarction; (b) Angina pectoris; (c) Coronary heart disease that has required treatment or, if untreated, that has been symptomatic or clinically significant; (d) Cardiac valve replacement; (e) Permanent cardiac pacemaker implantation; or (f) Heart replacement. ...

14 CFR 67.311 - Cardiovascular.

Code of Federal Regulations, 2013 CFR

2013-01-01

... diagnosis of any of the following: (a) Myocardial infarction; (b) Angina pectoris; (c) Coronary heart disease that has required treatment or, if untreated, that has been symptomatic or clinically significant; (d) Cardiac valve replacement; (e) Permanent cardiac pacemaker implantation; or (f) Heart replacement. ...

14 CFR 67.111 - Cardiovascular.

Code of Federal Regulations, 2012 CFR

2012-01-01

... diagnosis of any of the following: (1) Myocardial infarction; (2) Angina pectoris; (3) Coronary heart disease that has required treatment or, if untreated, that has been symptomatic or clinically significant; (4) Cardiac valve replacement; (5) Permanent cardiac pacemaker implantation; or (6) Heart replacement...

14 CFR 67.111 - Cardiovascular.

Code of Federal Regulations, 2014 CFR

2014-01-01

... diagnosis of any of the following: (1) Myocardial infarction; (2) Angina pectoris; (3) Coronary heart disease that has required treatment or, if untreated, that has been symptomatic or clinically significant; (4) Cardiac valve replacement; (5) Permanent cardiac pacemaker implantation; or (6) Heart replacement...

14 CFR 67.311 - Cardiovascular.

Code of Federal Regulations, 2012 CFR

2012-01-01

... diagnosis of any of the following: (a) Myocardial infarction; (b) Angina pectoris; (c) Coronary heart disease that has required treatment or, if untreated, that has been symptomatic or clinically significant; (d) Cardiac valve replacement; (e) Permanent cardiac pacemaker implantation; or (f) Heart replacement. ...

14 CFR 67.111 - Cardiovascular.

Code of Federal Regulations, 2013 CFR

2013-01-01

... diagnosis of any of the following: (1) Myocardial infarction; (2) Angina pectoris; (3) Coronary heart disease that has required treatment or, if untreated, that has been symptomatic or clinically significant; (4) Cardiac valve replacement; (5) Permanent cardiac pacemaker implantation; or (6) Heart replacement...

14 CFR 67.311 - Cardiovascular.

Code of Federal Regulations, 2011 CFR

2011-01-01

... diagnosis of any of the following: (a) Myocardial infarction; (b) Angina pectoris; (c) Coronary heart disease that has required treatment or, if untreated, that has been symptomatic or clinically significant; (d) Cardiac valve replacement; (e) Permanent cardiac pacemaker implantation; or (f) Heart replacement. ...

Oral health-related quality of life changes after placement of immediately loaded single implants in healed alveolar ridges or extraction sockets: a 5-year prospective follow-up study.

PubMed

Raes, Stefanie; Raes, Filiep; Cooper, Lyndon; Giner Tarrida, Luis; Vervaeke, Stijn; Cosyn, Jan; De Bruyn, Hugo

2017-06-01

The impact of single implants on oral health-related quality of life (OHRQoL) is scarcely investigated, especially when combined with immediate placement and loading in extraction sockets. The aim was to describe prospectively the changes of OHRQoL with single implants placed in the esthetic zone in healed ridges or in extraction sockets after 5 years. Ninety-six patients, enrolled at three clinical centers, received 102 single implants placed in a healed ridge (n = 54 implants/50 patients) or in extraction sockets (n = 48 implants/46 patients). Implants were immediately provisionalized, and permanent crowns were cemented after 12 weeks. Oral health impact profile questionnaires (OHIP-14) were completed before surgery, after 1 (provisional crown), 6 (permanent crown), 12 and 60 months, respectively. The overall OHIP-14 score pertains to seven domains with two items each and was assessed on a Likert scale of 0-4 (0 = never and 4 = very often). The evolution of the total OHIP-14 score and changes within all OHIP domains over time and between groups were assessed with a linear mixed-effect model analysis. After 5 years, overall implant survival was 98%. The total OHIP-14 score for both groups combined decreased from 0.50 at baseline to 0.17 at 6 months (P < 0.001), indicative of improvement. For both groups, this remained stable up to 5 years (P = 0.41). However, after 5 years, the total OHIP-14 score revealed a statistically significantly higher improvement in the healed group compared with the extraction group (P = 0.027). Missing a single tooth in the maxillary esthetic zone leads to limited OHRQoL problems as reflected by a low overall OHIP score. However, OHRQoL improves less in the extraction group, reflecting that replacing a missing tooth is perceived as more beneficial than replacing a present tooth. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Penile prosthesis implant: scientific advances and technological innovations over the last four decades.

PubMed

Chung, Eric

2017-02-01

Despite introduction of oral phosphodiesterase type 5 inhibitors and intracavernosal vasoactive agents, penile prosthesis implant remains a relevant and desired option with sales of penile prostheses continue to stay high, as many men became refractory to medical therapy and/or seeking a more effective and permanent therapy. There are two types of penile prosthesis implants: inflatable and non-inflatable types, and the inflatable penile implants can be subdivided into single-, two- and three-piece devices. Non-inflatable penile prosthesis (non-IPP) may be referred to as semi-rigid rod or malleable prosthesis. IPP is considered a superior option to malleable prosthesis as it produces penile rigidity and flaccidity that closely replicates a normal penile erectile function. Since the introduction of IPP by Scott in 1973, surgical landscape for penile prosthesis implantation has changed dramatically. Advances in prosthesis design, device technologies and surgical techniques have made penile prosthesis implant a more natural, durable and reliable device. The following article reviews the scientific advances and technological innovation in modern penile prosthesis implants over the last four decades.

Penile prosthesis implant: scientific advances and technological innovations over the last four decades

PubMed Central

2017-01-01

Despite introduction of oral phosphodiesterase type 5 inhibitors and intracavernosal vasoactive agents, penile prosthesis implant remains a relevant and desired option with sales of penile prostheses continue to stay high, as many men became refractory to medical therapy and/or seeking a more effective and permanent therapy. There are two types of penile prosthesis implants: inflatable and non-inflatable types, and the inflatable penile implants can be subdivided into single-, two- and three-piece devices. Non-inflatable penile prosthesis (non-IPP) may be referred to as semi-rigid rod or malleable prosthesis. IPP is considered a superior option to malleable prosthesis as it produces penile rigidity and flaccidity that closely replicates a normal penile erectile function. Since the introduction of IPP by Scott in 1973, surgical landscape for penile prosthesis implantation has changed dramatically. Advances in prosthesis design, device technologies and surgical techniques have made penile prosthesis implant a more natural, durable and reliable device. The following article reviews the scientific advances and technological innovation in modern penile prosthesis implants over the last four decades. PMID:28217449

76 FR 1261 - Establishment of the Permanent Certification Program for Health Information Technology

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-07

...This final rule establishes a permanent certification program for the purpose of certifying health information technology (HIT). This final rule is issued pursuant to the authority granted to the National Coordinator for Health Information Technology (the National Coordinator) by section 3001(c)(5) of the Public Health Service Act (PHSA), as added by the Health Information Technology for Economic and Clinical Health (HITECH) Act. The permanent certification program will eventually replace the temporary certification program that was previously established by a final rule. The National Coordinator will use the permanent certification program to authorize organizations to certify electronic health record (EHR) technology, such as Complete EHRs and/or EHR Modules. The permanent certification program could also be expanded to include the certification of other types of HIT.

10 kHz High-Frequency Spinal Cord Stimulation for Chronic Axial Low Back Pain in Patients With No History of Spinal Surgery: A Preliminary, Prospective, Open Label and Proof-of-Concept Study.

PubMed

Al-Kaisy, Adnan; Palmisani, Stefano; Smith, Thomas E; Pang, David; Lam, Khai; Burgoyne, William; Houghton, Russell; Hudson, Emma; Lucas, Jonathan

2017-01-01

To explore the effectiveness of 10 kHz high frequency spinal cord stimulation (HF10 therapy) treatment of chronic low back pain in patients who have not had spinal surgery. Patients with chronic low back pain without prior spinal surgery were evaluated by a team of spine surgeons to rule out any spinal pathology amenable to surgical interventions and by a multidisciplinary pain team to confirm eligibility for the study. After a successful (>50% back pain reduction) trial of HF10 therapy, enrolled subjects underwent permanent system implantation and were followed-up one year post-implant. About 95% of the enrolled subjects (20/21) received the permanent system. At 12 months post-implant, both back pain VAS score and ODI were significantly reduced compared with baseline values (by 73% and 48%, respectively); an estimated quality-adjusted life year gain of 0.47 and a reduction in opioid use by 64% was observed. Four more patients among those unable to work at baseline due to back pain were employed at 12 months post-implant. There were no serious adverse events. HF10 therapy may provide significant back pain relief, reduction in disability, improvement quality of life, and reduction in opioid use in chronic low back pain not resulting from spinal surgery. © 2016 The Authors. Neuromodulation: Technology at the Neural Interface published by Wiley Periodicals, Inc. on behalf of International Neuromodulation Society.

Sagittal and vertical load-deflection and permanent deformation of transpalatal arches connected with palatal implants: an in-vitro study.

PubMed

Crismani, Adriano G; Celar, Ales G; Burstone, Charles J; Bernhart, Thomas G; Bantleon, Hans-Peter; Mittlboeck, Martina

2007-06-01

The purposes of this laboratory investigation were to (1) measure the sagittal and vertical deflection of loaded transpalatal arches (TPAs) connected to a palatal implant, (2) measure the extent of permanent deformation of the connecting TPA in the sagittal and vertical directions, (3) test various wire dimensions in terms of deflection behavior, and (4) evaluate soldering vs laser welding vs adhesive bonding of TPAs in terms of load deflection behavior. Stainless steel wires of 6 dimensions were tested: 0.8 x 0.8, 0.9, 1, 1.1, 1.2, and 1.2 x 1.2 mm. For each dimension, 10 specimens were soldered to the palatal implant abutment, 10 were laser welded, and 10 were adhesively bonded to the implant abutment (total, 180 specimens). The measuring device applied increments of force of 50 cN, from 0 to 500 cN. Then the specimens were unloaded. The values were statistically described and analyzed with ANOVA and Wilcoxon rank sum tests. Absolute orthodontic anchorage without deformation of TPAs was not observed with the wire dimensions tested. To prevent loss of anchorage greater than 370 mum (sagittal deflection of 1.2 x 1.2 mm adhesively bonded TPA at 500 cN force level), wires thicker than 1.2 x 1.2 mm or cast anchorage elements must be considered for clinical practice. However, larger cross sections might cause more patient discomfort, and laboratory procedures increase costs.

In vivo dosimetry using a linear Mosfet-array dosimeter to determine the urethra dose in 125I permanent prostate implants.

PubMed

Bloemen-van Gurp, Esther J; Murrer, Lars H P; Haanstra, Björk K C; van Gils, Francis C J M; Dekker, Andre L A J; Mijnheer, Ben J; Lambin, Philippe

2009-01-01

In vivo dosimetry during brachytherapy of the prostate with (125)I seeds is challenging because of the high dose gradients and low photon energies involved. We present the results of a study using metal-oxide-semiconductor field-effect transistor (MOSFET) dosimeters to evaluate the dose in the urethra after a permanent prostate implantation procedure. Phantom measurements were made to validate the measurement technique, determine the measurement accuracy, and define action levels for clinical measurements. Patient measurements were performed with a MOSFET array in the urinary catheter immediately after the implantation procedure. A CT scan was performed, and dose values, calculated by the treatment planning system, were compared to in vivo dose values measured with MOSFET dosimeters. Corrections for temperature dependence of the MOSFET array response and photon attenuation in the catheter on the in vivo dose values are necessary. The overall uncertainty in the measurement procedure, determined in a simulation experiment, is 8.0% (1 SD). In vivo dose values were obtained for 17 patients. In the high-dose region (> 100 Gy), calculated and measured dose values agreed within 1.7% +/- 10.7% (1 SD). In the low-dose region outside the prostate (< 100 Gy), larger deviations occurred. MOSFET detectors are suitable for in vivo dosimetry during (125)I brachytherapy of prostate cancer. An action level of +/- 16% (2 SD) for detection of errors in the implantation procedure is achievable after validation of the detector system and measurement conditions.

Dosimetric variations in permanent breast seed implant due to patient arm position.

PubMed

Watt, Elizabeth; Husain, Siraj; Sia, Michael; Brown, Derek; Long, Karen; Meyer, Tyler

2015-01-01

Planning and delivery for permanent breast seed implant (PBSI) are performed with the ipsilateral arm raised; however, changes in implant geometry can be expected because of healing and anatomical motion as the patient resumes her daily activities. The purpose of this study is to quantify the effect of ipsilateral arm position on postplan dosimetry. Twelve patients treated at the Tom Baker Cancer Centre were included in this study. Patients underwent two postimplant CT scans on the day of implant (Day 0) and two scans approximately 8 weeks later (Day 60). One scan at each time was taken with the ipsilateral arm raised, recreating the planning scan position, and the other with both arms down in a relaxed position beside the body, recreating a more realistic postimplant arm position. Postplans were completed on all four scans using deformable image registration (MIM Maestro). On the Day 0 scan, the V200 for the evaluation planning target volume was significantly increased in the arm-down position compared with the arm-up position. Lung, rib, and chest wall dose were significantly reduced at both time points. Left anterior descending coronary artery, heart, and skin dose showed no significant differences at either time point. Although some dosimetric indices show significant differences between the arm-up and arm-down positions, the magnitude of these differences is small and the values remain indicative of implant quality. Despite the delivery of the majority of dose with the arm down, it is reasonable to use CT scans taken in the arm-up position for postplanning. Copyright © 2015 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.

Durable engraftment of genetically modified FVIII-secreting autologous bone marrow stromal cells in the intramedullary microenvironment.

PubMed

Lee, Sze Sing; Sivalingam, Jaichandran; Nirmal, Ajit J; Ng, Wai Har; Kee, Irene; Song, In Chin; Kiong, Chin Yong; Gales, Kristoffer A; Chua, Frederic; Pena, Edgar M; Ogden, Bryan E; Kon, Oi Lian

2018-04-23

Genetically modified FVIII-expressing autologous bone marrow-derived mesenchymal stromal cells (BMSCs) could cure haemophilia A. However, culture-expanded BMSCs engraft poorly in extramedullary sites. Here, we compared the intramedullary cavity, skeletal muscle, subcutaneous tissue and systemic circulation as tissue microenvironments that could support durable engraftment of FVIII-secreting BMSC in vivo. A zinc finger nuclease integrated human FVIII transgene into PPP1R12C (intron 1) of culture-expanded primary canine BMSCs. FVIII-secretory capacity of implanted BMSCs in each dog was expressed as an individualized therapy index (number of viable BMSCs implanted × FVIII activity secreted/million BMSCs/24 hours). Plasma samples before and after implantation were assayed for transgenic FVIII protein using an anti-human FVIII antibody having negligible cross-reactivity with canine FVIII. Plasma transgenic FVIII persisted for at least 48 weeks after implantation in the intramedullary cavity. Transgenic FVIII protein levels were low after intramuscular implantation and undetectable after both intravenous infusion and subcutaneous implantation. All plasma samples were negative for anti-human FVIII antibodies. Plasma concentrations and durability of transgenic FVIII secretion showed no correlation with the therapy index. Thus, the implantation site microenvironment is crucial. The intramedullary microenvironment, but not extramedullary tissues, supported durable engraftment of genetically modified autologous FVIII-secreting BMSCs. © 2018 National Cancer Centre of Singapore Pte Ltd. Journal of Cellular and Molecular Medicine published by John Wiley & Sons Ltd and Foundation for Cellular and Molecular Medicine.

Toolbox No. 2: Expanding the Role of Foster Parents in Achieving Permanency. Toolboxes for Permanency.

ERIC Educational Resources Information Center

Dougherty, Susan

Noting that over the last decade, the role of a foster parent has evolved from temporary caregiver to essential part of a professional team in determining the best long-term plan for children in their care, this guide focuses on practical ways in which best child welfare practice can be incorporated into the recruitment, training, and support of…

Silicone gel breast implants: science and testing.

PubMed

Kinney, Brian M; Jeffers, Lynn L C; Ratliff, Gregory E; Carlisle, Dan A

2014-07-01

Since the first generation of breast implants, major design innovations, including consistency of the gel, palpability and thickness of the shell, and barrier materials in the shell, have been introduced. Surgeons have not had metrics to assess and compare available implants. Research at independent laboratories included 4 tests: gel elasticity (the gel's ability to retain its shape), gel compression fracture (the resistance to permanent gel deformation), gel-shell peel (the integration of the gel with shell as a cohesive unit), and morphological analysis. Sientra's round High-Strength Cohesive (HSC) experienced the least gel elasticity (5.805 mm), whereas Allergan's round implants experienced the most (7.465 mm). Among shaped implants, Allergan 410 experienced the least gel elasticity (3.242 mm), whereas the Sientra HSC+ implant experienced the most (4.270 mm). Sientra's round (36.32 lbf) and shaped (44.16 lbf) implants demonstrated the highest resistance to gel fracture, with Allergan's implants demonstrating the least among round (23.06 lbf) implants and Mentor Contour Profile Gel (CPG) among shaped (30.45 lbf) implants. For the gel-shell peel test, Sientra's implant required over 26% greater force than Allergan's implant and over 35% greater force than Mentor's implant. Sientra's shaped implants required more than double the peel force than Allergan 410 (119% greater) and Mentor CPG (130% greater). Morphological results showed Sientra's implants preserved structural integrity (-1.10% change). The initial findings show that these implant characteristics are individual factors to be considered separately and are not necessarily correlative. Further study of implants using these and other testing techniques will help clinicians choose between implants.

Update on the Essure System for Permanent Birth Control.

PubMed

Fantasia, Heidi Collins

In 2002, the U.S. Food and Drug Administration approved the Essure system for permanent birth control. Implantation with this device offers a minimally invasive option for permanent female contraception that is placed during a brief office visit. Unlike laparoscopic tubal sterilization, the Essure procedure requires no hospitalization or general anesthesia, resulting in minimal recovery time. After a decade of stability in the report of adverse effects, the U.S. Food and Drug Administration noted a sharp increase in patient-reported adverse events, including chronic pelvic pain, irregular bleeding, allergic reactions, and autoimmune-like reactions. In response to this increase in complaints, the U.S. Food and Drug Administration issued updated guidelines for patient education and counseling. This article discusses those updates, as well as implications for nurses who provide health care to women seeking permanent contraception. © 2017 AWHONN, the Association of Women’s Health, Obstetric and Neonatal Nurses.

Magnetic forces and magnetized biomaterials provide dynamic flux information during bone regeneration.

PubMed

Russo, Alessandro; Bianchi, Michele; Sartori, Maria; Parrilli, Annapaola; Panseri, Silvia; Ortolani, Alessandro; Sandri, Monica; Boi, Marco; Salter, Donald M; Maltarello, Maria Cristina; Giavaresi, Gianluca; Fini, Milena; Dediu, Valentin; Tampieri, Anna; Marcacci, Maurilio

2016-03-01

The fascinating prospect to direct tissue regeneration by magnetic activation has been recently explored. In this study we investigate the possibility to boost bone regeneration in an experimental defect in rabbit femoral condyle by combining static magnetic fields and magnetic biomaterials. NdFeB permanent magnets are implanted close to biomimetic collagen/hydroxyapatite resorbable scaffolds magnetized according to two different protocols . Permanent magnet only or non-magnetic scaffolds are used as controls. Bone tissue regeneration is evaluated at 12 weeks from surgery from a histological, histomorphometric and biomechanical point of view. The reorganization of the magnetized collagen fibers under the effect of the static magnetic field generated by the permanent magnet produces a highly-peculiar bone pattern, with highly-interconnected trabeculae orthogonally oriented with respect to the magnetic field lines. In contrast, only partial defect healing is achieved within the control groups. We ascribe the peculiar bone regeneration to the transfer of micro-environmental information, mediated by collagen fibrils magnetized by magnetic nanoparticles, under the effect of the static magnetic field. These results open new perspectives on the possibility to improve implant fixation and control the morphology and maturity of regenerated bone providing "in site" forces by synergically combining static magnetic fields and biomaterials.

[Fine mesh metal endoprostheses for treatment of extensive cervical and intrathoracic tracheomalacia].

PubMed

Wilmes, E; Berger, H; Dienemann, H; Jolk, A

1994-01-01

The treatment of tracheal stenoses caused by tracheomalacia is mainly carried out by means of sleeve resection, tracheopexy with ring support or other tracheoplastic operative procedures. If patients cannot be treated by surgical operative strategies, conventional stents are usually used to dilate the trachea. The use of a self-expanding elastic metal prosthesis in 5 patients with tracheal airway obstruction caused by tracheomalacia proved to be a true alternative in the therapy of tracheobronchial stenoses. We report on the long term use of 5 patients with tracheal stenoses treated by implantation of elastic metal wallstents. The implantation of the stents resulted in immediate improvement in respiratory function in all 5 patients. None of the patients experienced complications secondary to the stent placement. The stents were well tolerated (long-time follow-up 26 months). The implantation of self-expanding metal stents type "wallstent" seems to offer alternative possibilities for the treatment of tracheomalacia.

LDR brachytherapy: can low dose rate hypersensitivity from the "inverse" dose rate effect cause excessive cell killing to peripherial connective tissues and organs?

PubMed

Leonard, B E; Lucas, A C

2009-02-01

Examined here are the possible effects of the "inverse" dose rate effect (IDRE) on low dose rate (LDR) brachytherapy. The hyper-radiosensitivity and induced radioresistance (HRS/IRR) effect benefits cell killing in radiotherapy, and IDRE and HRS/IRR seem to be generated from the same radioprotective mechanisms. We have computed the IDRE excess cell killing experienced in LDR brachytherapy using permanent seed implants. We conclude, firstly, that IDRE is a dose rate-dependent manifestation of HRS/IRR. Secondly, the presence of HRS/IRR or IDRE in a cell species or tissue must be determined by direct dose-response measurements. Thirdly, a reasonable estimate is that 50-80% of human adjoining connective and organ tissues experience IDRE from permanent implanted LDR brachytherapy. If IDRE occurs for tissues at point A for cervical cancer, the excess cell killing will be about a factor of 3.5-4.0 if the initial dose rate is 50-70 cGy h(-1). It is greater for adjacent tissues at lower dose rates and higher for lower initial dose rates at point A. Finally, higher post-treatment complications are observed in LDR brachytherapy, often for unknown reasons. Some of these are probably a result of IDRE excess cell killing. Measurements of IDRE need be performed for connective and adjacent organ tissues, i.e. bladder, rectum, urinary tract and small bowels. The measured dose rate-dependent dose responses should extended to <10 cGy h(-1) and involve multiple patients to detect patient variability. Results may suggest a preference for high dose rate brachytherapy or LDR brachytherapy without permanent retention of the implant seeds (hence the dose rates in peripheral tissues and organs remain above IDRE thresholds).

Nationwide Japanese Prostate Cancer Outcome Study of Permanent Iodine-125 Seed Implantation (J-POPS): first analysis on survival.

PubMed

Ito, Kazuto; Saito, Shiro; Yorozu, Atsunori; Kojima, Shinsuke; Kikuchi, Takashi; Higashide, Satoshi; Aoki, Manabu; Koga, Hirofumi; Satoh, Takefumi; Ohashi, Toshio; Nakamura, Katsumasa; Katayama, Norihisa; Tanaka, Nobumichi; Nakano, Masahiro; Shigematsu, Naoyuki; Dokiya, Takushi; Fukushima, Masanori

2018-06-22

Investigating oncological outcomes in patients registered in the Japanese Prostate Cancer Outcome Study of Permanent Iodine-125 Seed Implantation (J-POPS) in terms of biochemical relapse-free survival (bRFS) by the Phoenix and the newly developed J-POPS definitions, exploration of predictive factors for bRFS, and preliminary verification of pitfalls of prostate-specific antigen (PSA) failure definitions. Between July 2005 and June 2007, 2316 clinically localized patients underwent permanent seed implantation. The primary endpoint was bRFS. One of the secondary endpoints was overall survival (OS). The median age was 69 and performance status was 0 in 99.1% of participants. The median biologically effective dose (BED) was about 180 Gy 2 . During a median follow-up of 60.0 months, 8.4 and 5.9% had PSA failure by the Phoenix and the J-POPS definitions, respectively. The 5-year bRFSs based on the Phoenix and the J-POPS definitions were 89.1 and 91.6%, respectively. The 5-year OS was 97.3%. According to multivariate analyses, only age affected bRFS based on the Phoenix definition, whereas the risk group and BED independently affected bRFS based on the J-POPS definition. A spontaneous PSA decrease was seen in 91.1% of participants after PSA failure based on the Phoenix definition alone, but in only 22.2% after PSA failure based on the J-POPS definition alone. The world's largest registration study, J-POPS, consisted of patients with longevity, and a highly quality-controlled BED resulted in excellent bRFS and OS. The high likelihood of PSA bounce by the Phoenix definition should be taken into account, especially in younger patients. NCT00534196.

[Orgasm after curietherapy with permanent iodine-125 radioimplants for localized prostate cancer].

PubMed

Delaunay, B; Delannes, M; Salloum, A; Delavierre, D; Wagner, F; Jonca, F; Thoulouzan, M; Plante, P; Bachaud, J-M; Soulie, M; Huyghe, E

2011-12-01

Orgasm is a domain of male sexuality that remains underreported in literature. Our aim was to realize the first detailed analysis of orgasm in patients treated by 125 I permanent prostate brachytherapy for localized prostate cancer. In a series of 270 sexually active men treated by prostate brachytherapy (125I permanent implantation), 241 (89%), mean age of 65 (43-80), participated in a mailed survey about sexual function after a mean time of 36 months (9-70). Erectile and ejaculatory functions and orgasm were explored using a mailed questionnaire. Two questions focused on orgasm. The first was about quality of orgasm (fast/intense/late, difficult/weak/absent) and the second about the presence of painful orgasm and its frequency (always/sometimes/often). After prostate brachytherapy, 81.3% of sexually active men conserved ejaculation and 90% orgasm. There was a significant deterioration of the quality of orgasm (P=0.0001). More than 50% of the patients had an altered orgasm (weak, difficult, absent) after brachytherapy, vs 16% before implantation (P=0.001). Men with a diminished ejaculation volume often had a weak/difficult orgasm (P=0.007). Neoadjuvant hormonal therapy did not seem to impact the quality of orgasm or the frequency of painful ejaculation. Patients who had an IIEF-5 score higher than 12 had frequently intense orgasm (26.7% vs 2.7%; P<0.001) after brachytherapy. Sixty patients (30.3%) experienced often/sometimes painful ejaculation 12.9% (n=31) before implantation (P=0.0001). Most of the patients treated by prostate brachytherapy conserved orgasm after treatment. However, most of the patients described a deterioration of the quality of orgasm. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

Seed Placement in Permanent Breast Seed Implant Brachytherapy: Are Concerns Over Accuracy Valid?

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

Morton, Daniel, E-mail: dmorton@bccancer.bc.ca; Department of Physics and Astronomy, University of Victoria, Victoria, British Columbia; Hilts, Michelle

Purpose: To evaluate seed placement accuracy in permanent breast seed implant brachytherapy (PBSI), to identify any systematic errors and evaluate their effect on dosimetry. Methods and Materials: Treatment plans and postimplant computed tomography scans for 20 PBSI patients were spatially registered and used to evaluate differences between planned and implanted seed positions, termed seed displacements. For each patient, the mean total and directional seed displacements were determined in both standard room coordinates and in needle coordinates relative to needle insertion angle. Seeds were labeled according to their proximity to the anatomy within the breast, to evaluate the influence of anatomicmore » regions on seed placement. Dosimetry within an evaluative target volume (seroma + 5 mm), skin, breast, and ribs was evaluated to determine the impact of seed placement on the treatment. Results: The overall mean (±SD) difference between implanted and planned positions was 9 ± 5 mm for the aggregate seed population. No significant systematic directional displacements were observed for this whole population. However, for individual patients, systematic displacements were observed, implying that intrapatient offsets occur during the procedure. Mean displacements for seeds in the different anatomic areas were not found to be significantly different from the mean for the entire seed population. However, small directional trends were observed within the anatomy, potentially indicating some bias in the delivery. Despite observed differences between the planned and implanted seed positions, the median (range) V{sub 90} for the 20 patients was 97% (66%-100%), and acceptable dosimetry was achieved for critical structures. Conclusions: No significant trends or systematic errors were observed in the placement of seeds in PBSI, including seeds implanted directly into the seroma. Recorded seed displacements may be related to intrapatient setup adjustments. Despite observed seed displacements, acceptable postimplant dosimetry was achieved.« less

Triple-site pacing for cardiac resynchronization in permanent atrial fibrillation - Acute phase results from a prospective observational study.

PubMed

Marques, Pedro; Nobre Menezes, Miguel; Lima da Silva, Gustavo; Bernardes, Ana; Magalhães, Andreia; Cortez-Dias, Nuno; Carpinteiro, Luís; de Sousa, João; Pinto, Fausto J

2016-06-01

Multi-site pacing is emerging as a new method for improving response to cardiac resynchronization therapy (CRT), but has been little studied, especially in patients with atrial fibrillation. We aimed to assess the effects of triple-site (Tri-V) vs. biventricular (Bi-V) pacing on hemodynamics and QRS duration. This was a prospective observational study of patients with permanent atrial fibrillation and ejection fraction <40% undergoing CRT implantation (n=40). One right ventricular (RV) lead was implanted in the apex and another in the right ventricular outflow tract (RVOT) septal wall. A left ventricular (LV) lead was implanted in a conventional venous epicardial position. Cardiac output (using the FloTrac™ Vigileo™ system), mean QRS and ejection fraction were calculated. Mean cardiac output was 4.81±0.97 l/min with Tri-V, 4.68±0.94 l/min with RVOT septal and LV pacing, and 4.68±0.94 l/min with RV apical and LV pacing (p<0.001 for Tri-V vs. both BiV). Mean pre-implantation QRS was 170±25 ms, 123±18 ms with Tri-V, 141±25 ms with RVOT septal pacing and LV pacing and 145±19 with RV apical and LV pacing (p<0.001 for Tri-V vs. both BiV and pre-implantation). Mean ejection fraction was significantly higher with Tri-V (30±11%) vs. Bi-V pacing (28±12% with RVOT septal and LV pacing and 28±11 with RV apical and LV pacing) and pre-implantation (25±8%). Tri-V pacing produced higher cardiac output and shorter QRS duration than Bi-V pacing. This may have a significant impact on the future of CRT. Copyright © 2016 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.

Generation of a scaffold free cartilage-like implant from a small amount of starting material.

PubMed

Stoddart, M J; Ettinger, L; Häuselmann, H J

2006-01-01

An autologous cellular based treatment of a traumatic cartilage injury requires a procedure whereby a biopsy of healthy cartilage is removed from the patient and the cells isolated and expanded by monolayer passage. This increases the cell number to required levels but also leads to a de-differentiation of the cells. We aim to produce a scaffold-free, de-novo implant from a biopsy of cartilage. Bovine chondrocytes were isolated from a small biopsy and expanded. The chondrocytic phenotype of the monolayer expanded cells was recovered during a period of culture in alginate and the effect of factors such as IGF1, TFGbeta1 and dexamethasone was investigated. During the alginate culture period a pre-treatment with IGF1 and dexamethasone was shown to have little effect. IGF1 however increased the glycosaminoglycan/DNA (GAG/DNA) content on day 14 to 84.95+/-5 ng/ng compared with 37.3+/-1.8 ng/ng in the controls (P<0.001). 35S labeling demonstrated an increased GAG synthesis in the presence of IGF1 (P<0.001). IGF1 also induced a increase of DNA content 1383+/-314 ng/bead compared to 512+/-19 ng/bead in the controls (P<0.001). The cells were released from the alginate and cultured in a silicon mould for a further 14 days to obtain a three dimensional implant. Releasing the cells from the alginate and casting in a mould produced an implant of defined shape which contained no foreign material. After 31 days of culture the implants contained 152.4+/-13.14 ng/ng GAG/DNA and 42.93+/-10.23 ng/ng collagen II. We believe alginate released chondrocytes provide a real alternative to artificial scaffolds.

Are hearing losses among young Maori different to those found in the young NZ European population?

PubMed

Digby, Janet E; Purdy, Suzanne C; Kelly, Andrea S; Welch, David; Thorne, Peter R

2014-07-18

This study was undertaken to determine if young Maori have more permanent bilateral hearing loss, or less severe and profound hearing loss than New Zealand (NZ) Europeans. Data include hearing-impaired children from birth to 19 years of age from the New Zealand Deafness Notification Database (DND) and covering the periods 1982-2005 and 2009-2013. These were retrospectively analysed, as was information on children and young people with cochlear implants. Young Maori are more likely to be diagnosed with permanent hearing loss greater than 26 dB HL, averaged across speech frequencies, with 39-43% of hearing loss notifications listed as Maori. Maori have a lower prevalence of severe/profound losses (n=1571, chi squared=22.08, p=0.01) but significantly more bilateral losses than their NZ European peers (n=595, Chi-squared=9.05, p=0.01). The difference in severity profile is supported by cochlear implant data showing Maori are less likely to receive a cochlear implant. There are significant differences in the proportion of bilateral (compared to unilateral) losses and in the rates and severity profile of hearing loss among young Maori when compared with their NZ European peers. This has implications for screening and other hearing services in NZ.

Salvage low-dose-rate 125I partial prostate brachytherapy after dose-escalated external beam radiotherapy

PubMed Central

Chang, Lynn

2014-01-01

Purpose To report outcomes on 5 patients treated with salvage partial low-dose-rate (LDR) 125-iodine (125I) permanent prostate seed brachytherapy (BT) for biopsy-proven locally persistent prostate cancer, following failure of dose-escalated external beam radiotherapy (EBRT). Material and methods A retrospective review of the Fox Chase Cancer Center prostate cancer database identified five patients treated with salvage partial LDR 125I seed implant for locally persistent disease following dose-escalated EBRT to 76-84 Gy in 2 Gy per fraction equivalent. All patients had post-EBRT biopsies confirming unilateral locally persistent prostate cancer. Pre-treatment, EBRT and BT details, as well as post-treatment characteristics were documented and assessed. Results The median follow-up post-implant was 41 months. All five patients exhibited low acute genitourinary and gastrointestinal toxicities. Increased erectile dysfunction was noted in three patients. There were no biochemical failures following salvage LDR 125I seed BT to date, with a median post-salvage PSA of 0.4 ng/mL. Conclusions In carefully selected patients with local persistence of disease, partial LDR 125I permanent prostate seed implant appears to be a feasible option for salvage local therapy with an acceptable toxicity profile. Further study is needed to determine long-term results of this approach. PMID:25337135

Trends and Outcomes of Transcatheter Aortic Valve Implantation (TAVI) in Korea: the Results of the First Cohort of Korean TAVI Registry

PubMed Central

2018-01-01

Background and Objectives There has been no nation-wide data on the outcomes of transcatheter aortic valve implantation (TAVI) after commercialization of TAVI in Korea. We report clinical features and outcomes of the first cohort of TAVI performed from Jun 2015 to Jun 2017 in Korea. Methods The first cohort of Korean-TAVI (K-TAVI) registry includes 576 consecutive patients with severe symptomatic aortic stenosis who underwent TAVI from 17 Korean hospitals for 2 years. Results Most of TAVI procedures were performed for septuagenarians and octogenarians (90.8%) through transfemoral approach (98.3%). The rate of device success was 92.5% and permanent pacemaker was implanted in 5.6%. In successive years, incidences of paravalvular leakage (PVL) and major bleeding declined. Society of Thoracic Surgeons (STS) score was 5.2 (3.0 to 9.0) and 34.7% of patients had high surgical risk (STS ≥8). One-year all-cause death occurred in 8.9% and was significantly lower in low to intermediate risk one than in high risk (5.4% vs. 15.5%, p<0.001). The independent predictors of 1-year mortality were age (hazard ratio [HR], 1.087; 95% confidence interval [CI], 1.036–1.141; p=0.001), moderate or severe PVL (HR, 4.631; 95% CI, 1.624–13.203; p=0.004) and end-stage renal disease (HR, 5.785; 95% CI, 2.717–12.316; p<0.001). Conclusions K-TAVI registry showed favorable 1-year outcomes with decreasing complication rate over time in real-world Korean patients. Two-thirds of patients were low to intermediate surgical risk and showed a significantly lower mortality than the high-risk patients, suggesting the promising future on the expanded indications of TAVI. PMID:29671283

21 CFR 886.3100 - Ophthalmic tantalum clip.

Code of Federal Regulations, 2010 CFR

2010-04-01

... blood vessels in the eye. (b) Classification. Class II (special controls). The device is exempt from the...) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3100 Ophthalmic tantalum clip. (a) Identification. An ophthalmic tantalum clip is a malleable metallic device intended to be implanted permanently...

Transponders as permanent identification markers for domestic ferrets, black-footed ferrets, and other wildlife

USGS Publications Warehouse

Fagerstone, Kathleen A.; Johns, Brad E.

1987-01-01

A 0.05-g transponder implanted subcutaneously was tested to see if it provided a reliable identification method. In laboratory tests 20 domestic ferrets (Mustela putorius furo) received transponders and were monitored for a minimum of 6 months. None showed signs of inflammation, and necropsies conducted at the end of the study showed no scar tissue or transponder migration. Seven of 23 transponders failed during the test because of leakage through the plastic case, and a glass case is now being manufactured that does not have the leakage problem. During mark-recapture studies in September and October 1985, transponders were implanted in 20 black-footed ferrets (M. nigripes), 11 of which were subsequently recaptured and 9 of which were brought into captivity; none showed signs of inflammation. Transponders provide a reliable new method for identifying hard-to-mark wildlife with a unique, permanent number than can be read with the animal in-hand or by remote equipment.

Nerve damage related to implant dentistry: incidence, diagnosis, and management.

PubMed

Greenstein, Gary; Carpentieri, Joseph R; Cavallaro, John

2015-10-01

Proper patient selection and treatment planning with respect to dental implant placement can preclude nerve injuries. Nevertheless, procedures associated with implant insertion can inadvertently result in damage to branches of the trigeminal nerve. Nerve damage may be transient or permanent; this finding will depend on the cause and extent of the injury. Nerve wounding may result in anesthesia, paresthesia, or dysesthesia. The type of therapy to ameliorate the condition will be dictated by clinical and radiographic assessments. Treatment may include monitoring altered sensations to see if they subside, pharmacotherapy, implant removal, reverse-torquing an implant to decompress a nerve, combinations of the previous therapies, and/or referral to a microsurgeon for nerve repair. Patients manifesting altered sensations due to various injuries require different therapies. Transection of a nerve dictates immediate referral to a microsurgeon for evaluation. If a nerve is compressed by an implant or adjacent bone, the implant should be reverse-torqued away from the nerve or removed. When an implant is not close to a nerve, but the patient is symptomatic, the patient can be monitored and treated pharmacologically as long as symptoms improve or the implant can be removed. There are diverse opinions in the literature concerning how long an injured patient should be monitored before being referred to a microsurgeon.

Full-thickness skin with mature hair follicles generated from tissue culture expanded human cells.

PubMed

Wu, Xunwei; Scott, Larry; Washenik, Ken; Stenn, Kurt

2014-12-01

The goal of regenerative medicine is to reconstruct fully functional organs from tissue culture expanded human cells. In this study, we report a method for human reconstructed skin (hRSK) when starting with human cells. We implanted tissue culture expanded human epidermal and dermal cells into an excision wound on the back of immunodeficient mice. Pigmented skin covered the wound 4 weeks after implantation. Hair shafts were visible at 12 weeks and prominent at 14 weeks. Histologically, the hRSK comprises an intact epidermis and dermis with mature hair follicles, sebaceous glands and most notably, and unique to this system, subcutis. Morphogenesis, differentiation, and maturation of the hRSK mirror the human fetal process. Human antigen markers demonstrate that the constituent cells are of human origin for at least 6 months. The degree of new skin formation is most complete when using tissue culture expanded cells from fetal skin, but it also occurs with expanded newborn and adult cells; however, no appendages formed when we grafted both adult dermal and epidermal cells. The hRSK system promises to be valuable as a laboratory model for studying biological, pathological, and pharmaceutical problems of human skin.

[Atraumatic bone expansion: Interest of piezo-surgery, conicals expanders and immediate implantation combination].

PubMed

Iraqui, O; Lakhssassi, N; Berrada, S; Merzouk, N

2016-06-01

The durability of dental implants depends on the presence of a 1mm coating bone sheath all around the fixture. Therefore, bone resorption represents a challenge for the practitioner. Bone expansion is a surgical technique that allows the management of horizontal bone atrophy. Cortical bone splitting allows for an enlargement of the residual crest by displacement of the vestibular bone flap. The immediate placement of implants secures the widening and allows for a 97% survival rate. However, bone expansion is hard to undertake in sites with high bone density. Furthermore, the use of traditional instruments increases patient's stress and the risk for an interruptive fracture during bone displacement. Non-traumatic bone expansion is one solution to this problem. The combination of piezo-surgery and conical expanders allows for a secured displacement of the selected bone flap as well as an immediate implant placement, avoiding the risk of slipping, overheating, or fracture, all within an undeniable operative comfort. Non-traumatic bone expansion is a reliable, reproducible, conservative, and economical in time and cost procedure. We describe our atraumatic bone expension and immediate implant placement technique in high bone density sites and illustrate it by a clinical case. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Periprosthetic bleeding 18 years post-silicone reconstruction of the orbital floor.

PubMed

Ilie, Vlad Ionut; Ilie, Victor George; Quarmby, Craig; Lefter, Mihaela

2011-10-01

Periprosthetic orbital haemorrhage is an uncommon complication of the alloplastic implants used in post-traumatic orbital floor repair. The small case series or individual reports provide no definite causative explanation for this delayed bleeding around silicone implants. It is likely that it is related to the disruption of fine capillaries within the pseudocapsule surrounding the implant, since the material does cause low-grade irritation with evidence of chronic inflammation. We report the case of a patient who developed a spontaneous periprosthetic bleeding 18 years' post-silicone sheet reconstruction of the orbital floor. Urgent removal of the implant insured prompt resolution of all symptoms and no further problem during the 2-year follow-up. This report emphasizes that periprosthetic orbital haemorrhage can occur years after the initial repair. Awareness of this rare complication allows for prompt diagnosis, decreasing the possibility of permanent damage of the orbital content. The removal of implant is necessary to relieve the symptoms and prevent potential infective complications.

Application of the 2-piece orthodontic C-implant for provisional restoration with laser welded customized coping: a case report.

PubMed

Paek, Janghyun; Ahn, Hyo-Won; Jeong, Do-Min; Shim, Jeong-Seok; Kim, Seong-Hun; Chung, Kyu-Rhim

2015-03-25

This article presents the application of laser welding technique to fabricate an orthodontic mini-implant provisional restoration in missing area after limited orthodontic treatment. A 15-year-old boy case is presented. Two-piece orthodontic C-implant was placed after regaining space for missing right mandibular central incisor. Due to angular deviation of implant, customized abutment was required. Ready-made head part was milled and lingual part of customized abutment was made with non-precious metal. Two parts then were laser welded (Master 1000, Elettrolaser Italy, Verona, Italy) and indirect lab composite (3 M ESPE Sinfony, St. Paul, MN, USA) was built up. The patient had successful result, confirmed by clinical and radiographic examinations. Before the patient is ready to get a permanent restoration later on, this provisional restoration will be used. This case shows that a two-piece orthodontic C-implant system can be used to maintain small edentulous space after orthodontic treatment.

Predictors of Severe Tricuspid Regurgitation in Patients with Permanent Pacemaker or Automatic Implantable Cardioverter-Defibrillator Leads

PubMed Central

Najib, Mohammad Q.; Vittala, Satya S.; Challa, Suresh; Raizada, Amol; Tondato, Fernando J.; Lee, Howard R.; Chaliki, Hari P.

2013-01-01

Patients with permanent pacemaker or automatic implantable cardioverter-defibrillator (AICD) leads have an increased prevalence of tricuspid regurgitation. However, the roles of cardiac rhythm and lead-placement duration in the development of severe tricuspid regurgitation are unclear. We reviewed echocardiographic data on 26 consecutive patients who had severe tricuspid regurgitation after permanent pacemaker or AICD placement; before treatment, they had no organic tricuspid valve disease, pulmonary hypertension, left ventricular dysfunction, or severe tricuspid regurgitation. We compared the results to those of 26 control subjects who had these same devices but no more than mild tricuspid regurgitation. The patients and control subjects were similar in age (mean, 81 ±6 vs 81 ±8 yr; P = 0.83), sex (male, 42% vs 46%; P = 0.78), and left ventricular ejection fraction (0.60 ±0.06 vs 0.58 ± 0.05; P = 0.4). The patients had a higher prevalence of atrial fibrillation (92% vs 65%; P=0.01) and longer median duration of pacemaker or AICD lead placement (49.5 vs 5 mo; P < 0.001). After adjusting for age, sex, and right ventricular systolic pressure by multivariate logistic regression analysis, we found that atrial fibrillation (odds ratio=6.4; P = 0.03) and duration of lead placement (odds ratio=1.5/yr; P = 0.001) were independently associated with severe tricuspid regurgitation. Out study shows that atrial fibrillation and longer durations of lead placement might increase the risk of severe tricuspid regurgitation in patients with permanent pacemakers or AICDs. PMID:24391312

Peripheral neuromodulation: a review.

PubMed

Goroszeniuk, Teodor; Pang, David

2014-05-01

Peripheral nerve stimulation (PNS) is likely the most diverse and rapidly expanding area of neuromodulation. Its expansion has become possible due to both technological and clinical advances in pain medicine. The first implantable systems were surgically placed. However, it is currently commonplace to use percutaneous leads, as this approach has become instrumental in its expansion. The first percutaneous peripheral nerve stimulators were reported in 1999. Cylindrical leads were implanted to stimulate the greater occipital nerve to manage intractable headache. It has been expanded into other individual nerves or nerve plexuses to treat neuropathic, visceral, cardiac, abdominal, low back and facial pain. The use of PNS in modulating organ function in treatment of syndromes such as epilepsy, incontinence and obesity with vagal, tibial and gastric stimulation is under extensive investigation. New technologies that allow easier and safer electrode placement are expected to further expand the uses of PNS. A noninvasive stimulation will open this treatment modality to more clinicians of varying backgrounds.

How implantable cardioverter-defibrillators work and simple programming.

PubMed

Bryant, Randall M

2017-01-01

Following the sudden death of a friend in 1966, Dr Michel Mirowski began pioneering work on the first implantable cardioverter-defibrillator. By 1969 he had developed an experimental model and performed the first transvenous defibrillation. In 1970 he reported on the use of a "standby automatic defibrillator" that was tested successfully in dogs. He postulated that such a device "when adapted for clinical use, might be implanted temporarily or permanently in selected patients particularly prone to develop ventricular fibrillation and thus provide them with some degree of protection from sudden coronary death". In 1980 he reported on the first human implants of an "electronic device designed to monitor cardiac electrical activity, to recognise ventricular fibrillation and ventricular tachyarrhythmias … and then to deliver corrective defibrillatory discharges". Through innovations in circuitry, battery, and capacitor technologies, the current implantable cardioverter-defibrillator is 10 times smaller and exponentially more sophisticated than that first iteration. This article will review the inner workings of the implantable cardioverter-defibrillator and outline several features that make it the wonder in technology that it has become.

Expanded Equations for Torque and Force on a Cylindrical Permanent Magnet Core in a Large-Gap Magnetic Suspension System

NASA Technical Reports Server (NTRS)

Groom, Nelson J.

1997-01-01

The expanded equations for torque and force on a cylindrical permanent magnet core in a large-gap magnetic suspension system are presented. The core is assumed to be uniformly magnetized, and equations are developed for two orientations of the magnetization vector. One orientation is parallel to the axis of symmetry, and the other is perpendicular to this axis. Fields and gradients produced by suspension system electromagnets are assumed to be calculated at a point in inertial space which coincides with the origin of the core axis system in its initial alignment. Fields at a given point in the core are defined by expanding the fields produced at the origin as a Taylor series. The assumption is made that the fields can be adequately defined by expansion up to second-order terms. Examination of the expanded equations for the case where the magnetization vector is perpendicular to the axis of symmetry reveals that some of the second-order gradient terms provide a method of generating torque about the axis of magnetization and therefore provide the ability to produce six-degree-of-freedom control.

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.

SU-E-T-55: Biological Equivalent Dose (BED) Comparison Between Permanent Interstitial Brachytherapy and Conventional External Beam Radiotherapy for Prostate Cancer

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

Liu, X; Rahimian, J; Cosmatos, H

2014-06-01

Purpose: The goal of this research is to calculate and compare the Biological Equivalent Dose (BED) between permanent prostate Iodine-125 implant brachytherapy as monotherapy with the BED of conventional external beam radiation therapy (EBRT). Methods: A retrospective study of 605 patients treated with Iodine-125 seed implant was performed in which physician A treated 274 patients and physician B treated 331 patients. All the Brachytherapy treatment plans were created using VariSeed 8 planning system. The Iodine-125 seed source activities and loading patterns varied slightly between the two physicians. The prescription dose is 145 Gy to PTV for each patient. The BEDmore » and Tumor Control Probability (TCP) were calculated based on the TG 137 formulas. The BED for conventional EBRT of the prostate given in our institution in 2Gy per fraction for 38 fractions was calculated and compared. Results: Physician A treated 274 patients with an average BED of 123.92±0.87 Gy and an average TCP of 99.20%; Physician B treated 331 patients with an average BED of 124.87±1.12 Gy and an average TCP of 99.30%. There are no statistically significant differences (T-Test) between the BED and TCP values calculated for these two group patients.The BED of the patients undergoing conventional EBRT is calculated to be 126.92Gy. The BED of the patients treated with permanent implant brachytherapy and EBRT are comparable. Our BED and TCP values are higher than the reported values by TG 137 due to higher Iodine-125 seed activity used in our institution. Conclusion: We calculated the BED,a surrogate of the biological response to a permanent prostate brachytherapy using TG 137 formulas and recommendation. The TCP of better than 99% is calculated for these patients. A clinical outcome study of these patients correlating the BED and TCP values with PSA and Gleason Levels as well as patient survival is warranted.« less

Origins of endothelial and osteogenic cells in the subcutaneous collagen gel implant.

PubMed

Bilic-Curcic, I; Kalajzic, Z; Wang, L; Rowe, D W

2005-11-01

The interdependent relationship between vascular endothelial cells and osteoblasts during bone formation and fracture healing has been long appreciated. This paper reports a heterotopic implant model using FGF-2-expanded bone marrow stromal cells (BMSC) derived from Tie2eGFP (endothelial marker) and pOBCol3.6GFPcyan or topaz (early osteoblast marker) transgenic mice to appreciate the host/donor relationships of cells participating in the process of heterotopic bone formation. The study included various combinations of Tie2eGFP and pOBCol3.6GFPcyan and topaz transgenics as BMSC or whole bone marrow (WBM) donors and also as recipients. Rat tail collagen was used as a carrier of donor cells and implantation was done in lethally irradiated mice rescued with WBM injection. Development of ossicles in the implants was followed weekly during the 4- to 5-week long post-implantation period. By 4-5 weeks after total body irradiation (TBI) and implantation, a well-formed bone spicule had developed that was invested with bone marrow. Experiments showed absolute dominance of donor-derived cells in the formation of endothelial-lined vessels inside the implants as well as the marrow stromal-derived osteogenic cells. Host-derived fibroblasts and osteogenic cells were confined to the fibrous capsule surrounding the implant. In addition, cells lining the endosteal surface of newly formed marrow space carrying a pOBCol3.6GFP marker were observed that were contributed by WBM donor cells and the host. Thus, FGF-2-expanded BMSC appear to be a source of endothelial and osteogenic progenitor cells capable of eliciting heterotopic bone formation independent of cells from the host. This model should be useful for understanding the interactions between these two cell types that control osteogenic differentiation in vivo.

78 FR 14593 - Advisory Committee on the Medical Uses of Isotopes: Meeting Notice

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-06

... NUCLEAR REGULATORY COMMISSION Advisory Committee on the Medical Uses of Isotopes: Meeting Notice AGENCY: U.S. Nuclear Regulatory Commission. ACTION: Notice of Meeting. SUMMARY: NRC will convene a... enforcement policy for Permanent Implant Brachytherapy programs; (3) medical- related events from fiscal year...

[Effect of TGF-beta1 on embryo implantation and development in mice in vitro].

PubMed

Luo, Shan; Yin, Hai-ning; Li, Shang-wei

2010-03-01

To investigate the role of TGF-beta1 in embryo implantation and development in vitro in mice. Mouse embryos at 2-cell stage were cultured in the media of M16 with exposure to different levels of TGF-beta1 (0, 1, 10 and 50 ng/mL). The percentage of embryos reaching fixed stages (early blastocyst, expanding blastocyst and hatched blastocyst) was monitored 68 h and 92 h after the culture. The expanding blastocys cultured for 68 h in M16 without TGF-beta1 and those with 10 ng/mL of TGF-beta1 were transferred to pseudopregnant mice. On the 6th day post transfer, the successful rates of implantation were counted. The level of IL-10/IFN-gamma in the serum and maternal-fetus interface of the mice was detected by ELISA on the 6th day post transfer. TGF-beta1 improved embryo growth in vitro. TGF-beta1 at a level of 10 ng/mL had the maximum impact, with 15.6%, 68.09%, 1.42% of embryos reaching early, expanding, and hatched stage, respectively, 68 h after culture, and 6.38%, 28.37%, 53.19% of embryos reaching early, expanding, and hatched stage, respectively, 92 h after culture. The promoting effect declined when TGF-beta1 reached 50 ng/mL. The successful rate of implantation of embryos cultured in M16 with TGF-beta1 was significantly higher than those cultured in M16 without TGF-beta1 (35. 2% vs. 17.19%, P < 0.05). The embryos cultured in M16 with TGF-beta1 had significantly lower level of IFN-gamma in the maternal-fetus interface than those cultured in M16 without TGF-beta1 [(30.89 +/- 11.31) pg/mL vs. (43.23 +/- 18. 09) pg/mL, P < 0.053. TGF-beta1 at an appropriate dose improves embryo implantation in mice in vitro. The mechanism may involve the improvement of the quality of embryos and their development, and decrease of IFN-gamma synthesis in maternal-fetal interface, a chemical that could cause Th2 bias.

Tag retention, growth, and survival of red swamp crayfish marked with a visible implant tag

USGS Publications Warehouse

Isely, J.J.; Stockett, P.E.

2001-01-01

Eighty juvenile (means: 42.4 mm total length, 1.6 g) red swamp crayfish Procambarus clarkii were implanted with sequentially numbered visible implant tags and held in the laboratory. Tags were injected transversely into the musculature just beneath the exoskeleton of the third abdominal segment from the cephalothorax; tags were visible upon inspection. An additional 20 crayfish were left untagged and served as controls. After 150 d, tag retention was 80% and all tags were readable. No tagged crayfish died during the study, and no differences in total length or weight were detected between tagged and control crayfish. All individuals molted at least three times during the 150-d study, and some individuals molted up to six times, suggesting that most tags would be permanently retained. The readability in the field without specialized equipment makes the visible implant tag ideal for studies of crayfish ecology, management, and culture.

Biodegradable magnesium-based implants in bone studied by synchrotron radiation microtomography

NASA Astrophysics Data System (ADS)

Moosmann, Julian; Zeller-Plumhoff, Berit; Wieland, D. C. Florian; Galli, Silvia; Krüger, Diana; Dose, Thomas; Burmester, Hilmar; Wilde, Fabian; Bech, Martin; Peruzzi, Niccolò; Wiese, Björn; Hipp, Alexander; Beckmann, Felix; Hammel, Jörg; Willumeit-Römer, Regine

2017-09-01

Permanent implants made of titanium or its alloys are the gold standard in many orthopedic and traumatological applications due to their good biocompatibility and mechanical properties. However, a second surgical intervention is required for this kind of implants as they have to be removed in the case of children that are still growing or on patient's demand. Therefore, magnesium-based implants are considered for medical applications as they are degraded under physiological conditions. The major challenge is tailoring the degradation in a manner that is suitable for a biological environment and such that stabilization of the bone is provided for a controlled period. In order to understand failure mechanisms of magnesium-based implants in orthopedic applications and, further, to better understand the osseointegration, screw implants in bone are studied under mechanical load by means of a push-out device installed at the imaging beamline P05 of PETRA III at DESY. Conventional absorption contrast microtomography and phasecontrast techniques are applied in order to monitor the bone-to-implant interface under increasing load conditions. In this proof-of-concept study, first results from an in situ push-out experiment are presented.

Upper full arch rehabilitation with sinus by-pass with tilted implants via tapered-threaded expanders in low density bone: a clinical trial.

PubMed

Andreasi Bassi, M; Andrisani, C; Lico, S; Ormanier, Z; Arcuri, C

2016-01-01

In the present paper the use of tapered-screw bone expanders (TSBEs) is proposed, in combination with the placement of tilted implants, in close proximity to the anterior sinus wall, solving the problem of the reduced height of the alveolar bone in the sub-antral area. The Authors present a case series of full-arch rehabilitations performed with this procedure named: Tilted Implant Expansion Osteotomy (TIEO). 12 patients (5 males and 7 females, average age 58.5 ± 8.1 years) with totally or partially edentulous maxilla were enrolled in this study. For each patient 4 implants were placed, the anterior implants in the area of lateral incisors or canines while, the posterior implants, immediately in front of the maxillary sinus, with an inclined position. Adopting the aforesaid procedure, 48 cylindrical two-piece implants were placed, 24 of which were placed in tilted position, in order to by-pass the maxillary sinus. After a healing period of 6 months, the second stage surgery was performed. The cases were finalized by means of a hybrid metal-acrylic prosthesis. The post finalization follow-up was at 12 months. Survival rate was 100% since none fixtures were lost. At the one-year follow up the clinical and radiological appearance of the soft and hard tissues was optimal and no pathological signs were recorded. TIEO is a promising surgical procedure for full-arch rehabilitation of maxillary edentulous sites and represents a therapeutic alternative to sinus lift techniques.

Maxillary sinus by-pass with tilted implants via tapered-screw bone expanders in low density bone: one year follow -up of a case series.

PubMed

Andreasi Bassi, M; Andrisani, C; Lopez, M A; Gaudio, R M; Lombardo, L; Lauritano, D

2016-01-01

In the present paper the use of tapered-screw bone expanders (TSBEs) is proposed, in combination with the placement of tilted implants in close proximity to the anterior sinus wall, solving the problem of the reduced height of the alveolar bone in the sub-antral area. The Authors named the procedure: Tilted Implant Expansion Osteotomy (TIEO). Fifteen patients (10 females and 5 males, mean age 47.8±8.15 years) with distal edentulous maxillae were enrolled in this study. For each edentulous site 2 implants were placed, the anterior implant in the area of the most anterior missing tooth while, the posterior implant, immediately in front of the maxillary sinus, with an inclined position. Adopting the aforesaid procedure, 34 cylindrical two-piece implants were placed, 17 of which were placed in tilted position, in order to by-pass the maxillary sinus. After a healing period of 4-6 months, the second stage surgery was performed. The cases were finalized by metal-ceramic cementable restorations with a variable number of elements, from 2 to 4, without any cantilever element. The post finalization follow-up was at 12 months. Survival rate was 100% since no fixtures were lost. At the one-year follow-up the clinical and radiological appearance of the soft and hard tissues was optimal and no pathological signs were recorded. TIEO is a promising surgical procedure for oral rehabilitation of maxillary edentulous sites and represents a therapeutic alternative to sinus lift techniques.

Endoscopic management of complications of self-expandable metal stents for treatment of malignant esophageal stenosis and tracheoesophageal fistulas.

PubMed

Bor, Renáta; Fábián, Anna; Bálint, Anita; Farkas, Klaudia; Szűcs, Mónika; Milassin, Ágnes; Czakó, László; Rutka, Mariann; Molnár, Tamás; Szepes, Zoltán

2017-08-01

Self-expandable metal stent (SEMS) implantation may rapidly improve the symptoms of malignant esophageal stenosis and tracheoesophageal fistulas (TEF). However, dysphagia often returns subsequently and repeated endoscopic intervention may be necessary. The aims of the study were to identify the risk factors of complications, and the frequency and efficacy of repeated endoscopic interventions; and to provide technical recommendations on appropriate stent selection. We analyzed retrospectively the clinical data of 212 patients with locally advanced esophageal cancer who underwent SEMS implantation. A total of 238 SEMS implantations were performed with 99.06% technical success and 1.26% procedure-related deaths in the enrolled 212 cases. Complications occurred in 84 patients (39.62%) and in 55 cases (25.94%) repeated endoscopic procedures were required. Early reintervention 24-48 h after the stent implantations was necessary due to stent migration (12 cases), arrhythmia (2 cases), intolerable retrosternal pain (1 case) and dyspnea (1 case). An average of 1.98 repeated gastroscopies (range 1-6; median 2), 13.58 weeks (range 1.5-48; median 11) after the stent implantation were performed during the follow-up period: 37 stent repositions, 23 restent implantations, 15 endoscopic esophageal dilations and 7 stent removals. In 48 cases (87.3%) oral feeding of patients was made possible by endoscopic interventions. In a quarter of SEMS implantations, complications occur that can be successfully managed by endoscopic interventions. Our experiences have shown that individualized stent choice may substantially reduce the complications rate and make repeated endoscopic interventions easier.

Upper full arch rehabilitation with sinus by-pass with tilted implants via tapered-threaded expanders in low density bone: a clinical trial

PubMed Central

BASSI, M. ANDREASI; ANDRISANI, C.; LICO, S.; ORMANIER, Z.; ARCURI, C.

2016-01-01

SUMMARY Purpose In the present paper the use of tapered-screw bone expanders (TSBEs) is proposed, in combination with the placement of tilted implants, in close proximity to the anterior sinus wall, solving the problem of the reduced height of the alveolar bone in the sub-antral area. The Authors present a case series of full-arch rehabilitations performed with this procedure named: Tilted Implant Expansion Osteotomy (TIEO). Materials and methods 12 patients (5 males and 7 females, average age 58.5 ± 8.1 years) with totally or partially edentulous maxilla were enrolled in this study. For each patient 4 implants were placed, the anterior implants in the area of lateral incisors or canines while, the posterior implants, immediately in front of the maxillary sinus, with an inclined position. Adopting the aforesaid procedure, 48 cylindrical two-piece implants were placed, 24 of which were placed in tilted position, in order to by-pass the maxillary sinus. After a healing period of 6 months, the second stage surgery was performed. The cases were finalized by means of a hybrid metal-acrylic prosthesis. The post finalization follow-up was at 12 months. Results Survival rate was 100% since none fixtures were lost. At the one-year follow up the clinical and radiological appearance of the soft and hard tissues was optimal and no pathological signs were recorded. Conclusion TIEO is a promising surgical procedure for full-arch rehabilitation of maxillary edentulous sites and represents a therapeutic alternative to sinus lift techniques. PMID:28042432

Real-time computed tomography dosimetry during ultrasound-guided brachytherapy for prostate cancer.

PubMed

Kaplan, Irving D; Meskell, Paul; Oldenburg, Nicklas E; Saltzman, Brian; Kearney, Gary P; Holupka, Edward J

2006-01-01

Ultrasound-guided implantation of permanent radioactive seeds is a treatment option for localized prostate cancer. Several techniques have been described for the optimal placement of the seeds in the prostate during this procedure. Postimplantation dosimetric calculations are performed after the implant. Areas of underdosing can only be corrected with either an external beam boost or by performing a second implant. We demonstrate the feasibility of performing computed tomography (CT)-based postplanning during the ultrasound-guided implant and subsequently correcting for underdosed areas. Ultrasound-guided brachytherapy is performed on a modified CT table with general anesthesia. The postplanning CT scan is performed after the implant, while the patient is still under anesthesia. Additional seeds are implanted into "cold spots," and the resultant dosimetry confirmed with CT. Intraoperative postplanning was successfully performed. Dose-volume histograms demonstrated adequate dose coverage during the initial implant, but on detailed analysis, for some patients, areas of underdosing were observed either at the apex or the peripheral zone. Additional seeds were implanted to bring these areas to prescription dose. Intraoperative postplanning is feasible during ultrasound-guided brachytherapy for prostate cancer. Although the postimplant dose-volume histograms for all patients, before the implantation of additional seeds, were adequate according to the American Brachytherapy Society criteria, specific critical areas can be underdosed. Additional seeds can then be implanted to optimize the dosimetry and reduce the risk of underdosing areas of cancer.

Friction coefficient and effective interference at the implant-bone interface.

PubMed

Damm, Niklas B; Morlock, Michael M; Bishop, Nicholas E

2015-09-18

Although the contact pressure increases during implantation of a wedge-shaped implant, friction coefficients tend to be measured under constant contact pressure, as endorsed in standard procedures. Abrasion and plastic deformation of the bone during implantation are rarely reported, although they define the effective interference, by reducing the nominal interference between implant and bone cavity. In this study radial forces were analysed during simulated implantation and explantation of angled porous and polished implant surfaces against trabecular bone specimens, to determine the corresponding friction coefficients. Permanent deformation was also analysed to determine the effective interference after implantation. For the most porous surface tested, the friction coefficient initially increased with increasing normal contact stress during implantation and then decreased at higher contact stresses. For a less porous surface, the friction coefficient increased continually with normal contact stress during implantation but did not reach the peak magnitude measured for the rougher surface. Friction coefficients for the polished surface were independent of normal contact stress and much lower than for the porous surfaces. Friction coefficients were slightly lower for pull-out than for push-in for the porous surfaces but not for the polished surface. The effective interference was as little as 30% of the nominal interference for the porous surfaces. The determined variation in friction coefficient with radial contact force, as well as the loss of interference during implantation will enable a more accurate representation of implant press-fitting for simulations. Copyright © 2015 Elsevier Ltd. All rights reserved.

Functional evaluation of a CAD/CAM prosthesis for immediate defect repair after total maxillectomy: a case series of 18 patients with maxillary sinus cancer.

PubMed

Jiang, Fei-Fei; Hou, Yan; Lu, Li; Ding, Xiao-Xu; Li, Wei; Yan, Ai-Hui

2015-01-01

To evaluate the facial profiles and functional recovery of 18 patients treated by a computer-aided designed/manufactured hollow obturator prosthesis (CAD/CAM prosthesis) after total maxillectomy for malignant maxillary sinus tumor. A retrospective observational study was performed to evaluate the facial profiles and functional recovery of 18 patients with T3-4a N0 M0 maxillary sinus cancer, who were treated by total maxillectomy and simultaneous implantation of a computer-aided designed/manufactured hollow obturator prosthesis (CAD/CAM prosthesis). Follow-ups were performed 1, 3, 6, and 12 months after surgery. Facial measurements, speech intelligibility, and chewing and swallowing functions were examined. Thirteen patients converted to a permanent prosthesis 6 months after surgery. Comparisons were made between patients with and without the CAD/CAM or permanent prosthesis at various times using SPSS13.0 statistical software (SPSS Inc., Chicago, IL, USA). Speech intelligibility, facial depression, and eyeball prolapse results showed improvements with prosthesis use at 1, 3, and 6 months after surgery (p < 0.05). Swallowing function improved from level V to level II-IV with prosthesis use at 1, 3, and 6 months, and reached level I or II with permanent prosthesis use at 12 months after surgery. Simultaneous CAD/CAM prosthesis implantation recovered the facial profile, enhanced the speaking, swallowing, and chewing functions, and improved the quality of life of patients. Tumor recurrence can be detected by direct observation of the postoperative maxillary cavity. Therefore, this operation is recommended for simultaneous excision repair and functional reconstruction after total maxillectomy. This surgical treatment of maxillary sinus cancer is applied rarely in China, but it has a good effect based on our observation. Simultaneous CAD/CAM prosthesis implantation after total maxillectomy can recover the facial profile, enhance the speaking, swallowing, and chewing functions, and improve the quality of life of patients. Tumor recurrence can be detected by direct observation of the postoperative maxillary cavity. This technique avoids the need for dental implants because the bottom part of the prosthesis contains a palatal plate with dentures. © 2014 Wiley Periodicals, Inc.

The impact of postoperative expansion initiation timing on breast expander capsular characteristics: a prospective combined clinical and scanning electron microscopy study.

PubMed

Paek, Laurence S; Giot, Jean-Philippe; Tétreault-Paquin, Jean-Olivier; St-Jacques, Samuel; Nelea, Monica; Danino, M Alain

2015-04-01

In the first stage of expander-to-implant breast reconstruction, postoperative expansion is classically initiated at 10 to 14 days (conventional approach). The authors hypothesized that it may be beneficial to wait 6 weeks postoperatively before initiating serial expansion (delayed approach). Clinical and ultrastructural periprosthetic capsule analysis is first required before determining whether a delayed approach ultimately improves capsular tissue adherence and expansion process predictability. Patients undergoing two-stage implant-based breast reconstruction were enrolled prospectively in this study. During expander-to-implant exchange, the clinical presence of "Velcro" effect, biofilm, and double capsule was noted. Periprosthetic capsule samples were also sent for scanning electron microscopic observation of three parameters: surface relief, cellularity, and biofilm. Samples were divided into four groups for data analysis (group 1, conventional/Biocell; group 2, delayed/Biocell; group 3, conventional/Siltex; and group 4, delayed/Siltex). Fifty-six breast reconstructions were included. Each group comprised between 13 and 15 breasts. In group 1, no cases exhibited the Velcro effect and there was a 53.8 percent incidence of both biofilm and double capsule. In group 2, all cases demonstrated the Velcro effect and there were no incidences of biofilm or double capsule. Group 3 and group 4 cases did not exhibit a Velcro effect or double-capsule formation; however, biofilm was present in up to 20.0 percent. All group 2 samples revealed more pronounced three-dimensional relief on scanning electron microscopy. Variations in expansion protocols can lead to observable modifications in periprosthetic capsular architecture. There may be real benefits to delaying expander inflation until 6 weeks postoperatively with Biocell expanders.

A Longitudinal Assessment of Outcomes and Healthcare Resource Utilization After Immediate Breast Reconstruction-Comparing Implant- and Autologous-based Breast Reconstruction.

PubMed

Fischer, John P; Fox, Justin P; Nelson, Jonas A; Kovach, Stephen J; Serletti, Joseph M

2015-10-01

Immediate breast reconstruction (IBR) after mastectomy for cancer has increased in recent years, yet long-term, modality-specific comparative data are lacking. We performed this study to compare short- and long-term outcomes after expander, autologous (AT), and direct-to-implant (DI) breast reconstruction. Using four state-level inpatient and ambulatory surgery databases, we conducted a retrospective cohort study of adult women who underwent mastectomy with immediate breast reconstruction from 2008 to 2009. Our primary outcomes were complications within 90 days of surgery, rate of secondary breast surgery within 3 years, and cumulative healthcare charges. The final cohort included 15,154 women who underwent mastectomy with tissue expander (TE: 70.5%), autologous (AT: 18.1%), or direct to implant (DI: 11.3%) reconstruction. Ninety-day complications were lowest after expander and highest after AT breast reconstruction (TE = 6.5% [reference] vs AT = 13.1% [2.09, 1.82-2.41] vs DI = 6.6% [1.03, 0.84-1.27], P < 0.001). However, adjusted rates of secondary breast procedures were most frequent after expander (2021/1000 discharges) and least frequent after AT (949.0/1000 discharges) reconstruction (P < 0.001). Specifically, unplanned revisions were highest among the tissue expander cohort (TE = 59.2% vs AT = 34.4% vs DI = 45.9%, P < 0.001). The cumulative, adjusted healthcare charges for secondary breast procedures differed slightly across groups (TE = $63,806 vs AT = $66,882 vs DI = $64,145, P < 0.001). Complications and secondary breast procedures, including unplanned revisions, after breast reconstruction are common and vary by reconstructive modality. The frequency of these secondary procedures adds substantial healthcare charges to the care of the breast reconstruction patient.

Modeling seasonal dynamics of the small fish cohorts in fluctuating freshwater marsh landscapes

USGS Publications Warehouse

Jopp, Fred; DeAngelis, Donald L.; Trexler, Joel C.

2010-01-01

Small-bodied fishes constitute an important assemblage in many wetlands. In wetlands that dry periodically except for small permanent waterbodies, these fishes are quick to respond to change and can undergo large fluctuations in numbers and biomasses. An important aspect of landscapes that are mixtures of marsh and permanent waterbodies is that high rates of biomass production occur in the marshes during flooding phases, while the permanent waterbodies serve as refuges for many biotic components during the dry phases. The temporal and spatial dynamics of the small fishes are ecologically important, as these fishes provide a crucial food base for higher trophic levels, such as wading birds. We develop a simple model that is analytically tractable, describing the main processes of the spatio-temporal dynamics of a population of small-bodied fish in a seasonal wetland environment, consisting of marsh and permanent waterbodies. The population expands into newly flooded areas during the wet season and contracts during declining water levels in the dry season. If the marsh dries completely during these times (a drydown), the fish need refuge in permanent waterbodies. At least three new and general conclusions arise from the model: (1) there is an optimal rate at which fish should expand into a newly flooding area to maximize population production; (2) there is also a fluctuation amplitude of water level that maximizes fish production, and (3) there is an upper limit on the number of fish that can reach a permanent waterbody during a drydown, no matter how large the marsh surface area is that drains into the waterbody. Because water levels can be manipulated in many wetlands, it is useful to have an understanding of the role of these fluctuations.

Evaluation of a noninvasive expandable prosthesis in musculoskeletal oncology patients for the upper and lower limb.

PubMed

Beebe, Kathleen; Benevenia, Joseph; Kaushal, Neil; Uglialoro, Anthony; Patel, Neeraj; Patterson, Francis

2010-06-09

The noninvasive expandable prosthesis is used for limb-salvage surgery following tumor resection in skeletally immature patients. The purpose of this retrospective study is to report our experience with the Repiphysis (Wright Medical Technology, Inc; Arlington, Tennessee) noninvasive expandable prosthesis for both the lower extremity and compassionate use in the upper extremity in 12 patients between 2003 and 2008. Twelve prostheses were implanted in 12 patients with an average follow-up of 38 months (range, 12-78 months). Nine patients underwent a total of 38 expansion procedures. Mean total expansion was 4.5 cm (range, 0.8-9.9 cm). No complications of lengthening occurred. Seven nononcologic complications were noted. One infection was reported in 12 patients. The mean MSTS score after rehabilitation was 24.5 (range, 13-30). The Repiphysis noninvasive prosthesis provides acceptable functional outcomes for both upper and lower extremity implantation and appears to have an advantage as compared to conventional expandable prosthetics, which require open procedures that can potentially increase the risk of infection from repeated hardware exposure. Copyright 2010, SLACK Incorporated.

Peripheral nerve field stimulation (PNFS) in chronic low back pain: a prospective multicenter study.

PubMed

Kloimstein, Herwig; Likar, Rudolf; Kern, Michael; Neuhold, Josef; Cada, Miroslav; Loinig, Nadja; Ilias, Wilfried; Freundl, Brigitta; Binder, Heinrich; Wolf, Andreas; Dorn, Christian; Mozes-Balla, Eva Maria; Stein, Rolf; Lappe, Ivo; Sator-Katzenschlager, Sabine

2014-02-01

The goal of this study was to evaluate the long-term efficacy and safety of peripheral nerve field stimulation (PNFS) for chronic low back pain (cLBP). In this prospective, multicenter observational study, 118 patients were admitted to 11 centers throughout Austria and Switzerland. After a screening visit, all patients underwent a trial stimulation period of at least seven days before implantation of the permanent system. Leads were placed in the subcutaneous tissues of the lower back directly in the region of greatest pain. One hundred five patients were implanted with a permanent stimulating system. Patients' evaluation of pain and functional levels were completed before implantation and one, three, and six months after implantation. Adverse events, medication usage, and coverage of the painful area and predictive value of transcutaneous electrical nerve stimulation (TENS) were monitored. All pain and quality-of-life measures showed statistically significant improvement during the treatment period. These included the average pain visual analog scale, the Oswestry Disability Questionnaire, the Becks Depression Inventory, and the Short Form-12 item Health survey. Additionally, medication usage with opioids, nonsteroidal anti-inflammatory drugs, and anti-convulsants showed a highly significant reduction. Complications requiring surgical intervention were reported in 9.6% of the patients. The degree of coverage of painful areas seems to be an important criterion for efficacy of PNFS, whereas TENS is presumably no predictor. This prospective, multicenter study confirms that PNFS is an effective therapy for the management of cLBP. Significant improvements in many aspects of the pain condition were measured, and complications were minimal. © 2013 International Neuromodulation Society.

Neoteric Media as Tools for Process Intensification

NASA Astrophysics Data System (ADS)

Beh, C. C.; Mammucari, R.; Foster, N. R.

2017-06-01

Process intensification (PI) is a commonly used term in the chemical processing industry. When the concept of PI was first introduced in the late 1970s within the Imperial Chemical Industries (ICI) company, the main impetus was to reduce the processing cost without impairing the production rate. Neoteric media present as alternatives in chemical processing include gas-expanded liquids, ionic liquids, subcritical water, and combination of gas-expanded liquids and ionic liquids. The applications of neoteric media include particle engineering for improved bioavailability, controlled release of therapeutic implants, pharmaceutical formulations, extraction of natural products, nano-carriers for drug delivery, sterilisation of implants, and chemical reactions. This paper provides an overview of the use of these neoteric media.

Aesthetic remodeling of the healthy breast in breast reconstruction using expanders and implants.

PubMed

Mayo, Federico; Vecino, Maria González

2009-03-01

Breast reconstruction using expanders and implants still is the most common surgical procedure in many hospitals. The most important factor in obtaining a satisfactory aesthetic result for both the patient and the surgeon is to achieve the greatest symmetry possible between the healthy breast and the reconstructed breast. To get a good result, it is necessary to make an exhaustive preoperative examination that facilitates selection of the most suitable technique for remodeling the healthy breast and to choose the most suitable expander for placement on the side to be reconstructed. A retrospective study investigated 60 patients submitted to breast reconstruction between October 2005 and January 2008. The study analyzed the characteristics of the healthy breast (e.g., volume, ptosis), which is treated in the first part of the first operation. These characteristics are used later as a model for reconstructing the mastectomy side. The most adequate technique for remodeling the healthy breast based on its characteristics is indicated, as well as techniques not recommended for obtaining the desired symmetry. This study aimed to determine the basis for selecting the most appropriate technique to use in managing the healthy breast and obtaining the most aesthetic result in breast reconstruction. The healthy breast analysis allows an algorithm of indications to be elaborated based on the volume and degree of ptosis exhibited by the healthy breast. The healthy breast should resemble the reconstructed breast with its anatomic implant. In this study, the technique used most often to remodel the healthy breast was reduction surgery with a superomedial pedicle, and glandular flap (autoimplant) (30%). The results were highly satisfactory for both the patient and the surgeon. Aesthetic remodeling of the healthy breast is the first surgical treatment in breast reconstruction in two stages using expanders and implants. The expander for reconstruction of the other breast then is selected according to the measurements of the healthy modified breast. This reproducible and simple model of breast reconstruction, with its detailed preoperative plan, allows clinicians to obtain a good aesthetic result for breast reconstruction patients.

Superelastic Orthopedic Implant Coatings

NASA Astrophysics Data System (ADS)

Fournier, Eric; Devaney, Robert; Palmer, Matthew; Kramer, Joshua; El Khaja, Ragheb; Fonte, Matthew

2014-07-01

The demand for hip and knee replacement surgery is substantial and growing. Unfortunately, most joint replacement surgeries will fail within 10-25 years, thereby requiring an arduous, painful, and expensive revision surgery. To address this issue, a novel orthopedic implant coating material ("eXalt") has been developed. eXalt is comprised of super elastic nitinol wire that is knit into a three-dimensional spacer fabric structure. eXalt expands in vivo to conform to the implantation site and is porous to allow for bone ingrowth. The safety and efficacy of eXalt were evaluated through structural analysis, mechanical testing, and a rabbit implantation model. The results demonstrate that eXalt meets or exceeds the performance of current coating technologies with reduced micromotion, improved osseointegration, and stronger implant fixation in vivo.

SU-E-T-12: A Comparative Dosimetric Study of Pre and Post Prostate Iodine-125 Permanent Seed Implants

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

Liu, X; Rahimian, J; Goy, B

Purpose: Post-implant dosimetry has become the gold standard for prostate implant evaluation. The goal of this research is to compare the dosimetry between pre-plan and post-plan in permanent prostate seed implant brachytherapy. Methods: A retrospective study of 91 patients treated with Iodine-125 prostate seed implant between year 2012∼2014 were performed. All plans were created using a VariSeed 8.0 planning system. Pre-plan ultrasound images were acquired using 0.5 cm slice thickness. Post-plan CT images acquired about 1–4 weeks after implant, fused with the preplan ultrasound images. The prostate and urethra contours were generated using the fusion of ultrasound and CT images.more » Iodine-125 seed source activities varied between 0.382 to 0.414 mCi per seed. The loading patterns varied slightly between patients depending on the prostate size. Statistical analysis of pre and post plans for prostate and urethra volumes, V100%, V150% and D90, and urethra D10 were performed and reported. Results: The pre and post implant average prostate size was 36.90cc vs. 38.58cc; V100% was 98.33% vs. 96.89%; V150% was 47.09% vs. 56.95%; D90 was 116.35Gy vs. 116.12Gy, urethra volume was 1.72cc vs. 1.85cc, urethra D10% was 122.0% vs. 135.35%, respectively. There was no statistically significant difference between the pre and post-plan values for D90(p-value=0.43). However, there are significant differences between other parameters most likely due to post surgical edema; prostate size (p-value= 0.00015); V100% (p-value=3.7803E-07); V150% (p-value=1.49E-09); urethra volume (p-value= 2.77E-06); Urethra D10 (p-value=7.37E-11). Conclusion: The post-plan dosimetry using CT image set showed similar D90 dose coverage to the pre-plan using the ultrasound image dataset. The study showed that our prostate seed implants have consistently delivered adequate therapeutic dose to the prostate while sparing urethra. Future studies to correlate dose versus biochemical response using patients’ PSA values as well as patients’ survival are warranted.« less

The RAC program: what can radiology providers expect as RACs begin auditing?

PubMed

Pendleton, Abby; Gustafson, Jessica L

2009-01-01

The Centers for Medicare and Medicaid Services (CMS) Recovery Audit Contractor (RAC) program has been made permanent and is expanding nationwide. Radiology providers should be ready for increased Medicare auditing activity as the RAC expands. Should a provider or supplier be subject to a RAC audit, effective strategies are available that can be successfully employed in the appeals process to challenge denials.

The effect of microgeometry, implant thickness and polyurethane chemistry on the foreign body response to subcutaneous implants.

PubMed

Ward, W Kenneth; Slobodzian, Emily P; Tiekotter, Kenneth L; Wood, Michael D

2002-11-01

We addressed the effect of implant thickness, implant porosity, and polyurethane (PU) chemistry on angiogenesis and on the foreign body response in rats. The following materials were implanted subcutaneously for 7 weeks then excised for histologic analysis: a solid PU; a solid polyurethane with silicone and polyethylene oxide (PU-S-PEO); porous expanded polytetrafluoroethylene (ePTFE); and porous polyvinyl alcohol sponge (PVA). Two thicknesses of PU-S-PEO were compared: 300 microns (thin) and 2000 microns (thick). Foreign body capsule (FBC) thickness was much less in PU-S-PEO implants than in PU implants. In addition, FBC were thinner in thin implants than in thick implants. FBC was much more dense in solid implants than in porous implants. As compared with solid implants, porous implants (PVA and ePTFE) led to a marked increase in the number of microvessels that developed adjacent to the implant, as observed both with hematoxylin/eosin staining and with an immunohistochemical anti-endothelial stain. We conclude that the polyethylene oxide and silicone moieties in PU reduce the thickness of the subsequent FBC. In addition, thin implants lead to a thin FBC. Porous implants (PVA and ePTFE) cause more angiogenesis than solid implants. These results may have implications for the measurement of blood-derived analytes by biosensors.

Nummular Eczema of Breast: A Potential Dermatologic Complication after Mastectomy and Subsequent Breast Reconstruction

PubMed Central

Iwahira, Yoshiko; Nagasao, Tomohisa; Shimizu, Yusuke; Kuwata, Kumiko; Tanaka, Yoshio

2015-01-01

Purposes. The present paper reports clinical cases where nummular eczema developed during the course of breast reconstruction by means of implantation and evaluates the occurrence patterns and ratios of this complication. Methods. 1662 patients undergoing breast reconstruction were reviewed. Patients who developed nummular eczema during the treatment were selected, and a survey was conducted on these patients regarding three items: (1) the stage of the treatment at which nummular eczema developed; (2) time required for the lesion to heal; (3) location of the lesion on the reconstructed breast(s). Furthermore, histopathological examination was conducted to elucidate the etiology of the lesion. Results. 48 patients (2.89%) developed nummular eczema. The timing of onset varied among these patients, with lesions developing after the placement of tissue expanders for 22 patients (45.8%); after the tissue expanders were replaced with silicone implants for 12 patients (25%); and after nipple-areola complex reconstruction for 14 patients (29.2%). Nummular eczema developed both in periwound regions (20 cases: 41.7%) and in nonperiwound regions (32 cases: 66.7%). Histopathological examination showed epidermal acanthosis, psoriasiform patterns, and reduction of sebaceous glands. Conclusions. Surgeons should recognize that nummular eczema is a potential complication of breast reconstruction with tissue expanders and silicone implants. PMID:26380109

Expandable right ventricular-to-pulmonary artery conduit: an animal study.

PubMed

Boudjemline, Younes; Laborde, François; Pineau, Emmanuelle; Mollet, Alix; Abadir, Sylvia; Borenstein, Nicolas; Behr, Luc; Bonhoeffer, Philipp

2006-06-01

This study was performed to assess a new vascular stent graft as an expandable valved conduit for right ventricular outflow tract (RVOT) reconstruction in sheep. Conduits were constructed by sewing an 18-mm valved conduit inside a stent. Crimped to 16 mm, they were implanted either under or without extracorporeal circulation in seven (group A) and in five (group B) sheep, respectively. Six weeks and 3 mo after their insertion, conduits were dilated intraluminally. A valved stent was implanted percutaneously into conduits before they were killed. Two animals from group A recovered normally, whereas five animals had a complicated postoperative course. In group B, one died acutely due to kinking of the conduit. Balloon dilatations were performed in all surviving animals. First dilatations had a slight impact on valvular function in all animals but one, whereas second dilatations led to significant PR in all. Transcatheter valve implantation was performed successfully. When animals were killed, no bleeding was found around the surgically implanted device. In conclusion, we designed a biologic valved conduit for RVOT reconstruction that can be dilated sequentially to follow animal growth. This new device can have tremendous applications in children with congenital heart diseases involving the RVOT.

A mini axial and a permanent maglev radial heart pump.

PubMed

Qian, Kun-Xi; Ru, Wei-Min; Wang, Hao; Jing, Teng

2007-05-31

The implantability and durability have been for decades the focus of artificial heart R&D. A mini axial and a maglev radial pump have been developed to meet with such requirements.The mini axial pump weighing 27g (incl.5g rotor) has an outer diameter of 21mm and a length of 10mm in its largest point, but can produce a maximal blood flow of 6l/min with 50mmHg pressure increase. Therefore, it is suitable for the patients of 40-60kg body weight. For other patients of 60-80kg or 80-100kg body weight, the mini axial pumps of 23mm and 25mm outer diameter had been developed before, these devices were acknowledged to be the world smallest LVADs by Guinness World Record Center in 2004.The permanent maglev radial pump weighing 150g is a shaft-less centrifugal pump with permanent magnetic bearings developed by the author. It needs no second coil for suspension of the rotor except the motor coil, different from all other maglev pumps developed in USA, Japan, European, etc. Thus no detecting and controlling systems as well as no additional power supply for maglev are necessary. The pump can produce a blood flow up to as large as 10l/min against 100mmHg pressure.An implantable and durable blood pump will be a viable alternative to natural donor heart for transplantation.

Prevalence of venous obstruction in permanent endovenous pacing in newborns and infants: follow-up study.

PubMed

Stojanov, Petar; Vranes, Mile; Velimirovic, Dusan; Zivkovic, Mirjana; Kocica, Mladen J; Davidovic, Lazar; Neskovic, Voislava; Stajevic, Mila

2005-05-01

We examined the prevalence of venous obstruction in 12 newborns and infants with permanent endovenous ventricular pacing, clinically, and by ultrasonographic assessment of hemodynamics (spontaneity, phasicity, velocity, and turbulence of flow) and morphologic parameters (compressibility, wall thickness, and thrombus presence). All implantations of single ventricular unipolar endovenous steroid leads, were performed via cephalic vein, and pacemakers were placed in subcutaneous pocket in right prepectoral region. After the vascular surgeon has carefully examined all children for presence of venous collaterals in the chest wall, morphologic and hemodynamic parameters of the subclavian, axillary, and internal jugular veins, were assessed by linear-array color Doppler. Lead capacity (LC) was calculated for each patient. Mean age of patients at implant was 6.2 months (range 1 day-12 months), mean weight 6.5 kg (range 2.25-10 kg), and mean height 60.9 cm (range 48-78 cm). Mean LC was 1.99 (range 1.14-3.07). Total follow-up was 1023 and mean follow-up 85.2 pacing months (range 3-156). No clinical signs of venous obstruction were observed. Mild stenosis (20%) of subclavian vein was found by color Doppler in 2/12 patients. Both had adequate lead diameter for body surface. Permanent endovenous pacing is a feasible procedure, even in children of body weight less than 10 kg, with quite acceptable impact on venous system patency.

The CHARGE association: report of two cases.

PubMed

Venetikidou, A

1993-01-01

Although many reports of the CHARGE association appear in the literature, the dental findings were never discussed before. In this report of two cases, both patients present with delayed eruption of the permanent teeth and a remarkable similarity of the eruption pattern of the mandibular teeth. One lower permanent central incisor is congenitally missing, while the other is malformed. The lower permanent laterals of JM have erupted lingually and interfere with his speech and function of the tongue. Mandibular retrognathism is present. TM had a V-shaped constricted upper arch, which was expanded in a first phase of orthodontic intervention. Fixed appliances are the future considerations for the correction of the malocclusion.

Chronic recording of regenerating VIIIth nerve axons with a sieve electrode

NASA Technical Reports Server (NTRS)

Mensinger, A. F.; Anderson, D. J.; Buchko, C. J.; Johnson, M. A.; Martin, D. C.; Tresco, P. A.; Silver, R. B.; Highstein, S. M.

2000-01-01

A micromachined silicon substrate sieve electrode was implanted within transected toadfish (Opsanus tau) otolith nerves. High fidelity, single unit neural activity was recorded from seven alert and unrestrained fish 30 to 60 days after implantation. Fibrous coatings of genetically engineered bioactive protein polymers and nerve guide tubes increased the number of axons regenerating through the electrode pores when compared with controls. Sieve electrodes have potential as permanent interfaces to the nervous system and to bridge missing connections between severed or damaged nerves and muscles. Recorded impulses might also be amplified and used to control prosthetic devices.

A survey of cardiac implantable electronic device implantation in India: By Indian Society of Electrocardiology and Indian Heart Rhythm Society.

PubMed

Shenthar, Jayaprakash; Bohra, Shomu; Jetley, Vinay; Vora, Amit; Lokhandwala, Yash; Nabar, Ashish; Naik, Ajay; Calambur, Narsimhan; Gupta, S B

2016-01-01

There is limited data regarding the demographics and type of cardiac implantable electronic device (CIED) in India. The aim of this survey was to define trends in CIED implants, which included permanent pacemakers (PM), intracardiac defibrillators (ICD), and cardiac resynchronization therapy pacemakers and defibrillators (CRT-P/D) devices in India. The survey was the initiative of the Indian Society of Electrocardiology and the Indian Heart Rhythm Society. The type of CIED used, their indications, demographic characteristics, clinical status and co-morbidities were collected using a survey form over a period of 1 year. 2117 forms were analysed from 136 centers. PM for bradyarrhythmic indication constituted 80% of the devices implanted with ICD's and CRT-P/D forming approximately 10% each. The most common indication for PM implantation was complete atrio-ventricular block (76%). Single chamber (VVI) pacemakers formed 54% of implants, majority in males (64%). The indication for ICD implantation was almost equal for primary and secondary prevention. A single chamber ICD was most commonly implanted (65%). Coronary artery disease was the etiology in 58.5% of patients with ICD implants. CRT pacemakers were implanted mostly in patients with NYHA III/IV (82%), left ventricular ejection fraction <0.35 (88%) with CRT-P being most commonly used (57%). A large proportion of CIED implants in India are PM for bradyarrhythmic indications, predominantly AV block. ICD's are implanted almost equally for primary and secondary prophylaxis. Most CRT devices are implanted for NYHA Class III. There is a male predominance for implantation of CIED. Copyright © 2015 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

Symptomatic Post Endarterectomy Common Carotid Artery Pseudoaneurysm Treated with Combination of Flow Diverter Implantation and Carotid Stenting

PubMed Central

Imbarrato, Greg; Gordhan, Ajeet

2018-01-01

A 74-year-old male developed cervical carotid artery psuedoaneurysm 8 months after carotid endarterectomy. The patient was successfully managed with dual implantation of flow-diverter and conventional carotid stent. Flow-diverter was placed across the neck of pseudoaneurysm to provide flow diversion while carotid stent was implanted within the lumen of the expanded flow-diverter to approximate and hold the flow diverter proximal and distal to the pseudoaneurysm. Follow-up ultrasonography revealed complete resolution of the pseudoaneurysm. PMID:29535899

Postpneumonectomy syndrome in children: advantages and long-term follow-up of expandable prosthesis.

PubMed

Podevin, G; Larroquet, M; Camby, C; Audry, G; Plattner, V; Heloury, Y

2001-09-01

Pneumonectomy in children can be complicated by a severe mediastinal shift, which leads to bronchial stretching resulting in severe respiratory failure. This postpneumonectomy syndrome can be corrected by inserting a prosthesis in the empty side of the chest. Forty-two children, from 6 months to 15 years old, underwent a pneumonectomy. Seven of these patients were treated surgically for severe manifestations of postpneumonectomy syndrome. First insertion of an expandable prosthesis was followed up in 5 cases by its replacement with a breast prosthesis in adolescence. The expandable prosthesis was injected periodically with saline solution to maintain the mediastinum in a midline position as the children grew. The mean delay between pneumonectomy and first prosthesis implantation was 5 years (range, 11 months to 8 years). Pulmonary function tests showed a substantial improvement in the obstructive syndrome in all patients except one, in whom the functional improvement was moderate. The mean follow-up after the expandable prosthesis implantation was 6 years (range, 6 months to 10 years) and all patients are doing well. The insertion of an intrathoracic prosthesis can dramatically improve the clinical symptoms and reduce the functional obstructive syndrome. The expandable prosthesis allowed for progressive, well-tolerated recentering of the mediastinum and adjustment for growth. Copyright 2001 by W.B. Saunders Company.

[Preliminary study of constructing tissue-engineered cartilage with the endoskeletal scaffold of HDPE by bone marrow stromal cells].

PubMed

Zhu, Lie; Jiang, Hua; Zhou, Guang-Dong; Wu, Yu-Jia; Luo, Xu-Song

2008-09-01

To explore the feasibility of using a nonreactive, permanent endoskeletal scaffold to create the prothesis in special shape which is covered with tissue-engineered cartilage. Porcine BMSCs and articular chondrocytes were isolated and expanded respectively in vitro. Porcine BMSC of passage 1 in the concentration of 10 x 10(7)/ml were seeded onto a cylinder-shaped PGA (1 mm in thickness)/Medpor (3mm in diameter and 5mm in highness) scaffold as the experimental group. After the cell-scaffold constructs were cultured for 5 days, the primary medium, high-glucose DMEM medium with 10% fetal bovine serum (FBS), was replaced by chondrogenically inductive medium for 4 weeks. BMSCs and chondrocytes of the same concentration were seeded respectively onto the scaffold as the negative control group and the positive control group. After cultured in vitro for 4 weeks, the cell-scaffolds construct were implanted into subcutaneous pockets on the back of nude mice. Four and eight weeks later, the formed cartilage prosthesis were harvested and then evaluated by gross view, histology, immunohistochemistry and glycosamino-glycan (GAG) content. Cells in all groups had fine adhesion to the scaffold and could secrete extracellular matrix. All specimens in experimental group and positive control group formed mature cartilage with collagen II expression.The mature catrtilage wraped HDPE compactly and grown into the gap of HDPE. Mature lacuna structures and metachromatic matrices were also observed in these specimens. GAG contents in experimental group were (5.13 +/- 0.32) mg/g (4 weeks), (5.37 +/- 0.12) mg/g (8 weeks). In contrast, specimens in BMSC group showed mainly fibrous tissue. It indicates that it is feasible to create special shaped tissue-engineering cartilage with the permanent internal support using BMSCs as seed cell.

Clinical and Microbiological Characterization of Late Breast Implant Infections after Reconstructive Breast Cancer Surgery.

PubMed

Franchelli, Simonetta; Pesce, Marianna; Savaia, Serena; Marchese, Anna; Barbieri, Ramona; Baldelli, Ilaria; De Maria, Andrea

2015-10-01

Implant infections represent a relevant problem after immediate breast cancer reconstruction. In addition to difficulties in distinguishing early infections from other post-surgical complications (such as hematoma, seroma, and liponecrosis) late breast implant infections still represent a grey area of our knowledge with regards to heir definition and management. To address this issue, we prospectively monitored breast cancer patients at their center. Between February 1, 2009, and May 31, 2013, we enrolled all patients undergoing breast implant reconstruction or expander-to-prosthesis substitution. Patients without at least 6 mo of post-operative observation were excluded. We collected data from patient records including age, days from surgery (DFS), chemotherapy/radiotherapy, infecting microorganism, type of implant, antibiotic management and eventual implant removal. Sixty days from surgery were defined as the clinical threshold between early and late infection. Infections were further classified according to a graded scale into possible, probable and microbiologically proved. Seventy-eight infections were recorded out of 766 surgical procedures (10.2%). Fifty-three (67%) cases occurred early ≤60 DFS, and 25 (33%) occurred late (i.e., beyond 60 d). By defining infection types as possible, probable or proved, the majority of late infections were classified as proved (84%) compared with 56% of early infections (p=0.0014). Microbiological isolate distribution was similar in proved early infections compared with proved late infections. Among late infections, a delayed occurrence was observed after prosthesis placement compared with expander insertion. Late infections were fraught with lower treatment success rates (12% vs. 41%, p=0.009). Late infection represents a consistent proportion of infections after immediate breast implant reconstruction or prosthesis placement and bear lower chance of salvage after treatment. An increased attention is warranted to improve prevention and treatment strategies.

Dosimetry around metallic ports in tissue expanders in patients receiving postmastectomy radiation therapy: an ex vivo evaluation.

PubMed

Moni, Janaki; Graves-Ditman, Maria; Cederna, Paul; Griffith, Kent; Krueger, Editha A; Fraass, Benedick A; Pierce, Lori J

2004-01-01

Postmastectomy breast reconstruction can be accomplished utilizing tissue expanders and implants. However, in patients who require postoperative radiotherapy, the complication rate with tissue expander/implant reconstruction can exceed 50%. One potential cause of this high complication rate may be the metallic port in the tissue expander producing altered dosimetry in the region of the metallic device. The purpose of this study was to quantify the radiation dose distribution in the vicinity of the metallic port and determine its potential contribution to this extremely high complication rate. The absolute dosimetric effect of the tissue expander's metallic port was quantified using film and thermoluminescent dosimetry (TLD) studies with a single beam incident on a metallic port extracted from an expander. TLD measurements were performed at 11 reproducible positions on an intact expander irradiated with tangential fields. A computed tomography (CT)-based treatment plan without inhomogeneity corrections was used to derive expected doses for all TLD positions. Multiple irradiation experiments were performed for all TLD data. Confidence intervals for the dose at TLD sites with the metallic port in place were compared to the expected dose at the site without the metallic port. Film studies did not reveal a significant component of scatter around the metallic port. TLD studies of the extracted metallic port revealed highest doses within the casing of the metallic port and no consistent increased dose at the surface of the expander. No excess dose due to the metallic port in the expander was noted with the phantom TLD data. Based upon these results, it does not appear that the metallic port in tissue expanders significantly contributes to the high complication rate experienced in patients undergoing tissue expander breast reconstruction and receiving radiation therapy. Strategies designed to reduce the breast reconstruction complication rate in this clinical setting will need to focus on factors other than adjusting the dosimetry around the tissue expander metallic port.

Expanding hollow metal rings

DOEpatents

Peacock, Harold B [Evans, GA; Imrich, Kenneth J [Grovetown, GA

2009-03-17

A sealing device that may expand more planar dimensions due to internal thermal expansion of a filler material. The sealing material is of a composition such that when desired environment temperatures and internal actuating pressures are reached, the sealing materials undergoes a permanent deformation. For metallic compounds, this permanent deformation occurs when the material enters the plastic deformation phase. Polymers, and other materials, may be using a sealing mechanism depending on the temperatures and corrosivity of the use. Internal pressures are generated by either rapid thermal expansion or material phase change and may include either liquid or solid to gas phase change, or in the gaseous state with significant pressure generation in accordance with the gas laws. Sealing material thickness and material composition may be used to selectively control geometric expansion of the seal such that expansion is limited to a specific facing and or geometric plane.

Clinical Outcome After 8 to 10 Years of Immediately Restored Single Implants Placed in Extraction Sockets and Healed Ridges.

PubMed

Raes, Stefanie; Cosyn, Jan; Noyelle, Anabel; Raes, Filiep; De Bruyn, Hugo

Recent systematic reviews point to the scarcity of single implants followed up longer than 5 years, and the incidence of biologic/technical complications is underreported. This prospective follow-up study documents 8- to 10-year clinical outcomes of immediately restored single implants in extraction sockets (immediate implant treatment [IIT]) and healed bone (conventional implant treatment [CIT]). Patients received a single, chemically modified, moderately rough titanium implant and a provisional crown on the day of surgery in the anterior maxilla (second premolar to second premolar). Provisional crowns were replaced by permanent crowns after 10 weeks. Implant survival, complications, crestal bone changes, plaque score, probing depth, and bleeding on probing were regularly recorded up to 10 years of follow-up. Of 16 patients who underwent IIT, 11 could be evaluated after 8 years. Of the 23 patients who received an implant in healed bone, 18 were finally evaluated. One implant failed in the IIT group at 12 weeks; all implants survived in the CIT group; 38% of the patients experienced at least one complication; 10% had one or more biologic complications, whereas 31% experienced one or more technical complications. There were no significant changes in crestal bone level from 1 to ≥ 8 years of follow-up for either group or between IIT and CIT at any time point (P ≥ .129). Only 6.9% (2 of 29) implants demonstrated progressive bone loss > 2 mm combined with pockets ≥ 6 mm. Immediately restored single implants in extraction sockets and healed ridges demonstrate good long-term outcomes in terms of implant survival, crestal bone loss, and peri-implant health. However, biologic and especially technical complications are common.

Intraoperative Nerve Blocks Fail to Improve Quality of Recovery after Tissue Expander Breast Reconstruction: A Prospective, Double-Blinded, Randomized, Placebo-Controlled Clinical Trial.

PubMed

Lanier, Steven T; Lewis, Kevin C; Kendall, Mark C; Vieira, Brittany L; De Oliveira, Gildasio; Nader, Anthony; Kim, John Y S; Alghoul, Mohammed

2018-03-01

The authors' study represents the first level I evidence to assess whether intraoperative nerve blocks improve the quality of recovery from immediate tissue expander/implant breast reconstruction. A prospective, randomized, double-blinded, placebo-controlled clinical trial was conducted in which patients undergoing immediate tissue expander/implant breast reconstruction were randomized to either (1) intraoperative intercostal and pectoral nerve blocks with 0.25% bupivacaine with 1:200,000 epinephrine and 4 mg of dexamethasone or (2) sham nerve blocks with normal saline. The 40-item Quality of Recovery score, pain score, and opioid use in the postoperative period were compared statistically between groups. Power analysis ensured 80 percent power to detect a 10-point (clinically significant) difference in the 40-item Quality of Recovery score. Forty-seven patients were enrolled. Age, body mass index, laterality, mastectomy type, and lymph node dissection were similar between groups. There were no statistical differences in quality of recovery, pain burden as measured by visual analogue scale, opioid consumption, antiemetic use, or length of hospital stay between groups at 24 hours after surgery. Mean global 40-item Quality of Recovery scores were 169 (range, 155 to 182) for the treatment arm and 165 (range, 143 to 179) for the placebo arm (p = 0.36), indicating a high quality of recovery in both groups. Although intraoperative nerve blocks can be a safe adjunct to a comprehensive postsurgical recovery regimen, the authors' results indicate no effect on overall quality of recovery from tissue expander/implant breast reconstruction. Therapeutic, I.

A novel three-dimensional printed guiding device for electrode implantation of sacral neuromodulation.

PubMed

Cui, Z; Wang, Z; Ye, G; Zhang, C; Wu, G; Lv, J

2018-01-01

The aim was to test the feasibility of a novel three-dimensional (3D) printed guiding device for electrode implantation of sacral neuromodulation (SNM). A 3D printed guiding device for electrode implantation was customized to patients' anatomy of the sacral region. Liquid photopolymer was selected as the printing material. The details of the device designation and prototype building are described. The guiding device was used in two patients who underwent SNM for intractable constipation. Details of the procedure and the outcomes are given. With the help of the device, the test needle for stimulation was placed in the target sacral foramen successfully at the first attempt of puncture in both patients. The time to implant a tined SNM electrode was less than 20 min and no complications were observed. At the end of the screening phase, symptoms of constipation were relieved by more than 50% in both patients and permanent stimulation was established. The customized 3D printed guiding device for implantation of SNM is a promising instrument that facilitates a precise and quick implantation of the electrode into the target sacral foramen. Colorectal Disease © 2017 The Association of Coloproctology of Great Britain and Ireland.

Biocompatibility tests of components of an implantable cardiac assist device.

PubMed

von Recum, A F; Imamura, H; Freed, P S; Kantrowitz, A; Chen, S T; Ekstrom, M E; Baechler, C A; Barnhart, M I

1978-09-01

A permanently implantable in-series left ventricular assist device, the dynamic aortic patch (DAP), has been tested in chronic animal experiments. The DAP replaces a section of the intrathoracic aortic wall. Hemothorax and hematocele at the implantation site have been complications in recent experiments. Primary postoperative hemorrhage was ruled out, and the biocompatibility of all components was therefore examined. Dacron velour, Teflon felt, conductive polyurethane, segmented polyether polyurethane, and Teflon-coated polyester fiber sutures were implanted in the pleural cavities of dogs and tested in vitro by culturing canine saphenous vein explants on them. In vivo experiments demonstrated that all components elicited mild to moderate inflammatory reactions, but hematocele occurred only when the components were implanted in the aorta with direct blood contact and exposed to arterial blood pressures. In vitro, cells were cultured on all components with no signs of toxic reactions. These results indicated that the host tolerated all implant components without major inflammatory responses. However, histological data indicated that chronic slow bleeding into or through the Dacron velour in contact with the arterial blood serum could account for hemothorax or hematocele formation. Therefore, a configuration of the assist device using materials impermeable to blood may obviate these difficulties.

Management of stent dislodgment in coarctoplasty of aorta with three overlapping self-expandable nitinol stents.

PubMed

Ghazi, Payam; Haji-Zeinali, Ali-Mohammad

2010-01-01

We describe a case of native coarctation of aorta managed with three self-expandable nitinol stents. After balloon pre-dilation, the first and second stents were dislodged. The coarcted area was successfully treated with the third stent overlapped with the previous stents. During follow up (30 months), the patient was free of complications. It seems that implantation of multiple overlapping self-expandable stents in aortic coarctation patients, if needed, is safe and possible.

21 CFR 870.3680 - Cardiovascular permanent or temporary pacemaker electrode.

Code of Federal Regulations, 2010 CFR

2010-04-01

... applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. (2... end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The...

21 CFR 870.3680 - Cardiovascular permanent or temporary pacemaker electrode.

Code of Federal Regulations, 2013 CFR

2013-04-01

... applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. (2... end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The...

21 CFR 870.3680 - Cardiovascular permanent or temporary pacemaker electrode.

Code of Federal Regulations, 2011 CFR

2011-04-01

... applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. (2... end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The...

21 CFR 870.3680 - Cardiovascular permanent or temporary pacemaker electrode.

Code of Federal Regulations, 2012 CFR

2012-04-01

... applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. (2... end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The...

21 CFR 870.3680 - Cardiovascular permanent or temporary pacemaker electrode.

Code of Federal Regulations, 2014 CFR

2014-04-01

... applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. (2... end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The...

An implanted 8-channel array coil for high-resolution macaque MRI at 3T

PubMed Central

Janssens, T.; Keil, B.; Farivar, R.; McNab, J.A.; Polimeni, J. R.; Gerits, A.; Arsenault, J.T.; Wald, L. L.; Vanduffel, W.

2012-01-01

An 8-channel receive coil array was constructed and implanted adjacent to the skull in a male rhesus monkey in order to improve the sensitivity of (functional) brain imaging. The permanent implant was part of an acrylic headpost assembly and only the coil element loop wires were implanted. The tuning, matching, and preamplifier circuitry was connected via a removable external assembly. Signal-to-noise ratio (SNR) and noise amplification for parallel imaging were compared to a single-, 4-, and 8-channel external receive-only coil routinely used for macaque fMRI. In vivo measurements showed significantly improved SNR within the brain for the implanted versus the external coils. Within a region-of-interest covering the cerebral cortex, we observed a 5.4-, 3.6-fold, and 3.4-fold increase in SNR compared to the external single-, 4-, and 8-channel coil, respectively. In the center of the brain, the implanted array maintained a 2.4×, 2.5×, and 2.1× higher SNR, respectively compared to the external coils. The array performance was evaluated for anatomical, diffusion tensor and functional brain imaging. This study suggests that a stable implanted phased-array coil can be used in macaque MRI to substantially increase the spatial resolution for anatomical, diffusion tensor, and functional imaging. PMID:22609793

Extraocular surgery for implantation of an active subretinal visual prosthesis with external connections: feasibility and outcome in seven patients.

PubMed

Besch, D; Sachs, H; Szurman, P; Gülicher, D; Wilke, R; Reinert, S; Zrenner, E; Bartz-Schmidt, K U; Gekeler, F

2008-10-01

Due to low energy levels in microphotodiode-based subretinal visual prostheses, an external power supply is mandatory. We report on the surgical feasibility and the functional outcome of the extraocular part of an approach to connect a subretinal prosthesis to an extracorporeal connector in the retro-auricular space via a trans-scleral, transchoroidal cable. Seven volunteers with retinitis pigmentosa received an active subretinal implant; energy was supplied by gold wires on a trans-sclerally, transchoroidally implanted polyimide foil leading to the lateral orbital rim where it was fixated and connected to a silicone cable. The cable was implanted subperiostally beneath the temporal muscle using a trocar to the retro-auricular space where it penetrated the skin for connection to a stimulator. To avoid subretinal movement of the implant, three tension relief points have been introduced. All implantations were performed as planned without complications, and no serious adverse events occurred in the postoperative period. Fixation of the implants was stable throughout the entire study duration of 4 weeks; permanent skin penetration proved to be uncomplicated. Motility was minimally restricted in downgaze and ab-/adduction. Explantation was uneventful. The above-described procedure provides a method for stable fixation of a subretinal device with a trans-scleral, transchoroidal cable connection to an extracorporeal connector.

Current requirements for polymeric biomaterials in otolaryngology

PubMed Central

Sternberg, Katrin

2011-01-01

In recent years otolaryngology was strongly influenced by newly developed implants which are based on both, innovative biomaterials and novel implant technologies. Since the biomaterials are integrated into biological systems they have to fulfill all technical requirements and accommodate biological interactions. Technical functionality relating to implant specific mechanical properties, a sufficiently high stability in terms of physiological conditions, and good biocompatibility are the demands with regard to suitability of biomaterials. The goal in applying biomaterials for implants is to maintain biofunctionality over extended periods of time. These general demands to biomaterials are equally valid for use in otolaryngology. Different classes of materials can be utilized as biomaterials. Metals belong to the oldest biomaterials. In addition, alloys, ceramics, inorganic glasses and composites have been tested successfully. Furthermore, natural and synthetic polymers are widely used materials, which will be in the focus of the current article with regard to their properties and usage as cochlear implants, osteosynthesis implants, stents, and matrices for tissue engineering. Due to their application as permanent or temporary implants materials are differentiated into biostable and biodegradable polymers. The here identified general and up to date requirements for biomaterials and the illustrated applications in otolaryngology emphasize ongoing research efforts in this area and at the same time demonstrate the high significance of interdisciplinary cooperation between natural sciences, engineering, and medical sciences. PMID:22073104

Troponin T elevation after permanent pacemaker implantation.

PubMed

Chen, Xueying; Yu, Ziqing; Bai, Jin; Hu, Shulan; Wang, Wei; Qin, Shengmei; Wang, Jingfeng; Sun, Zhe; Su, Yangang; Ge, Junbo

2017-08-01

The objective of the study is to study the incidence, significance, and factors associated with cardiac troponin T (CTNT) elevation after pacemaker implantation. Three hundred seventy-four patients (104 single-chamber pacemakers or ICD, 243 dual-chamber pacemakers, and 27 cardiac resynchronization therapy/cardiac resynchronization therapy defibrillator) who had normal levels of CTNT at baseline and underwent implantation of a permanent pacemaker system were included in this study. Serum levels of CTNT were measured at baseline, 6 and 24 h after the implantation procedure. The median of CTNT levels increased from 0.012 ng/mL at baseline to 0.032 and 0.019 ng/mL at 6 and 24 h after the procedure, respectively (all p < 0.0001). Elevated CTNT levels were noted in 208 patients (55.6%) at 6 h after the implantation, among which 29 patients (7.8%) had CTNT levels exceeding the range of minimal myocardial damage (>0.09 ng/mL). After 1-year follow-up, the incidence of complications including dislodgement of the lead, pocket infection, pneumothorax, hemothorax, and vein thrombus and cardiac outcomes including hospitalization of heart failure, coronary artery disease, arrhythmia, and cardiovascular mortality was not significantly different between the normal and elevated CTNT groups at 6 h after the procedure. By logistic regression analysis, gender, N-terminal pro-B type natriuretic peptide (NT-pro-BNP) at baseline, left ventricular ejection fractions (LVEF), estimated glomerular filtration rate (eGFR), and fluoroscopy time were independently associated with CTNT elevation after adjusted for age, pacemaker types, right ventricle lead location (RVA or RVOT), heart function, and left ventricular end systolic dimension. Pacemaker implantation was found to be accompanied with CTNT elevation in 55.6% of the patients at 6 h after the procedure, and its kinetics were fast, which might not be related to the complications and adverse cardiac outcomes within 1 year of follow-up. Moreover, gender, NT-pro-BNP at baseline, LVEF, eGFR, and fluoroscopy time were found to be independent predictors of CTNT elevation.

Permanent epicardial pacing in pediatric patients: 12-year experience at a single center.

PubMed

Kwak, Jae Gun; Kim, Soo-Jin; Song, Jin Young; Choi, Eun Young; Lee, Sang Yoon; Shim, Woo Sup; Lee, Chang-Ha; Lee, Cheul; Park, Chun Soo

2012-02-01

Permanent cardiac pacing is not often done in children, and when done is usually accomplished through epicardial pacing. We reviewed a 12-year experience with the implantation of epicardial pacemakers by our clinical group. Fifty-three patients who underwent their first implantation of an epicardial pacemaker before the age of 18 years and between 1997 and 2009 were included in our study. The mean age of the patients at the time of first pacemaker implantation was 5.7±4.8 years. Indications for pacemaker implantation included postoperative or congenital atrioventricular block and sinus node dysfunction. The patients underwent 105 operations for the replacement of pacemaker pulse generators and 75 operations for the replacement of pacemaker leads. The most commonly used generator mode was the rate-responsive accelerometer-based (DDDR) mode, which was used in 40.9% of the patients. We used more non-steroid-eluting leads (70.1%) than steroid-eluting leads (29.1%). The overall duration of follow-up in the study was 8.0±4.5 years (range, 2.1 months to approximately 17.0 years). Freedom from the need for generator replacement was 98.0%, 60.7%, and 11.1% at 1, 5, and 8 years, respectively. A tendency toward early generator exhaustion was observed among younger patients (p=0.058). The generator mode used for pacing did not significantly affect generator longevity. Freedom from the need for lead replacement was 98.3%, 83.8%, and 63.6% at 1, 5, and 10 years, respectively. The mean longevity of the leads used in the study was 10.8±0.8 years. Neither patient age at the time of lead implantation nor type of lead significantly affected lead longevity. Lead longevity was sufficiently long and did not vary significantly according to type of lead. Generator longevity was not affected by lead type, generator mode, or patient age at the time of pacemaker implantation. Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Implant for in-vivo parameter monitoring, processing and transmitting

DOEpatents

Ericson, Milton N [Knoxville, TN; McKnight, Timothy E [Greenback, TN; Smith, Stephen F [London, TN; Hylton, James O [Clinton, TN

2009-11-24

The present invention relates to a completely implantable intracranial pressure monitor, which can couple to existing fluid shunting systems as well as other internal monitoring probes. The implant sensor produces an analog data signal which is then converted electronically to a digital pulse by generation of a spreading code signal and then transmitted to a location outside the patient by a radio-frequency transmitter to an external receiver. The implanted device can receive power from an internal source as well as an inductive external source. Remote control of the implant is also provided by a control receiver which passes commands from an external source to the implant system logic. Alarm parameters can be programmed into the device which are capable of producing an audible or visual alarm signal. The utility of the monitor can be greatly expanded by using multiple pressure sensors simultaneously or by combining sensors of various physiological types.

Implantable device for in-vivo intracranial and cerebrospinal fluid pressure monitoring

DOEpatents

Ericson, Milton N.; McKnight, Timothy E.; Smith, Stephen F.; Hylton, James O.

2003-01-01

The present invention relates to a completely implantable intracranial pressure monitor, which can couple to existing fluid shunting systems as well as other internal monitoring probes. The implant sensor produces an analog data signal which is then converted electronically to a digital pulse by generation of a spreading code signal and then transmitted to a location outside the patient by a radio-frequency transmitter to an external receiver. The implanted device can receive power from an internal source as well as an inductive external source. Remote control of the implant is also provided by a control receiver which passes commands from an external source to the implant system logic. Alarm parameters can be programmed into the device which are capable of producing an audible or visual alarm signal. The utility of the monitor can be greatly expanded by using multiple pressure sensors simultaneously or by combining sensors of various physiological types.

Analysis of a five year experience of permanent pacemaker implantation at a Nigerian Teaching Hospital: need for a national database

PubMed Central

Falase, Bode; Sanusi, Michael; Johnson, Adeyemi; Akinrinlola, Fola; Ajayi, Reina; Oke, David

2013-01-01

Introduction Permanent pacemaker implantation is available in Nigeria. There is however no national registry or framework for pacemaker data collection. A pacemaker database has been developed in our institution and the results are analyzed in this study. Methods The study period was between January 2008 and December 2012. Patient data was extracted from a prospectively maintained database which was designed to include the fields of the European pacemaker patient identification code. Results Of the 51 pacemaker implants done, there were 29 males (56.9%) and 22 females (43.1%). Mean age was 68.2±12.7 years. Clinical indications were syncopal attacks in 25 patients (49%), dizzy spells in 15 patients (29.4%), bradycardia with no symptoms in 10 patients (17.7%) and dyspnoea in 2 patients (3.9%). The ECG diagnosis was complete heart block in 27 patients (53%), second degree heart block in 19 patients (37.2%) and sick sinus syndrome with bradycardia in 5 patients (9.8%). Pacemaker modes used were ventricular pacing in 29 patients (56.9%) and dual chamber pacing in 22 patients (43.1%). Files have been closed in 20 patients (39.2%) and 31 patients (60.8%) are still being followed up with median follow up of 26 months, median of 5 visits and 282 pacemaker checks done. Complications seen during follow up were 3 lead displacements (5.9%), 3 pacemaker infections (5.9%), 2 pacemaker pocket erosions (3.9%), and 1 pacemaker related death (2%). There were 5 non-pacemaker related deaths (9.8%). Conclusion Pacemaker data has been maintained for 5 years. We urge other implanting institutions in Nigeria to maintain similar databases and work towards establishment of a national pacemaker registry. PMID:24498465

Valve in valve transcatheter aortic valve implantation (ViV-TAVI) versus redo-Surgical aortic valve replacement (redo-SAVR): A systematic review and meta-analysis.

PubMed

Nalluri, Nikhil; Atti, Varunsiri; Munir, Abdullah B; Karam, Boutros; Patel, Nileshkumar J; Kumar, Varun; Vemula, Praveen; Edla, Sushruth; Asti, Deepak; Paturu, Amrutha; Gayam, Sriramya; Spagnola, Jonathan; Barsoum, Emad; Maniatis, Gregory A; Tamburrino, Frank; Kandov, Ruben; Lafferty, James; Kliger, Chad

2018-05-20

Bioprosthetic (BP) valves have been increasingly used for aortic valve replacement over the last decade. Due to their limited durability, patients presenting with failed BP valves are rising. Valve in Valve - Transcatheter Aortic Valve Implantation (ViV-TAVI) emerged as an alternative to the gold standard redo-Surgical Aortic Valve Replacement (redo-SAVR). However, the utility of ViV-TAVI is poorly understood. A systematic electronic search of the scientific literature was done in PubMed, EMBASE, SCOPUS, Google Scholar, and ClinicalTrials.gov. Only studies which compared the safety and efficacy of ViV-TAVI and redo-SAVR head to head in failed BP valves were included. Six observational studies were eligible and included 594 patients, of whom 255 underwent ViV- TAVI and 339 underwent redo-SAVR. There was no significant difference between ViV-TAVI and redo- SAVR for procedural, 30 day and 1 year mortality rates. ViV-TAVI was associated with lower risk of permanent pacemaker implantation (PPI) (OR: 0.43, CI: 0.21-0.89; P = 0.02) and a trend toward increased risk of paravalvular leak (PVL) (OR: 5.45, CI: 0.94-31.58; P = 0.06). There was no significant difference for stroke, major bleeding, vascular complications and postprocedural aortic valvular gradients more than 20 mm-hg. Our results reiterate the safety and feasibility of ViV-TAVI for failed aortic BP valves in patients deemed to be at high risk for surgery. VIV-TAVI was associated with lower risk of permanent pacemaker implantation with a trend toward increased risk of paravalvular leak. © 2018, Wiley Periodicals, Inc.

Sci-Thur PM – Brachytherapy 02: Positional accuracy in Pd-103 permanent breast seed implant (PBSI) brachytherapy at the Tom Baker Cancer Centre (TBCC)

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

Frederick, Amy; Watt, Elizabeth; Peacock, Michael

Purpose: This retrospective study aims to quantify the positional accuracy of seed delivery in permanent breast seed implant (PBSI) brachytherapy at the Tom Baker Cancer Centre (TBCC). Methods: Treatment planning and post-implant CT scans for 5 patients were rigidly registered using the MIM Symphony™ software (MIM Software, Cleveland, OH) and used to evaluate differences between planned and implanted seed positions. Total and directional seed displacements were calculated for each patient in a clinically relevant ‘needle coordinate system’, defined relative to the angle of fiducial needle insertion. Results: The overall average total seed displacement was 10±8 mm. Systematic seed displacements weremore » observed in individual patients and the magnitude and direction of these offsets varied among patients. One patient showed a significant directional seed displacement in the shallow-deep direction compared with the other four patients. With the exception of this one patient outlier, no significant systematic directional displacements in the needle coordinate system were observed for this cohort; the average directional displacements were −1±5 mm, 2±3 mm, and −2±4 mm in the shallow-deep, up-down, and right-left directions respectively. Conclusion: With the exception of one patient outlier, the magnitude of seed displacements were relatively consistent among patients. The results indicate that the shallow-deep direction possesses the largest uncertainty for the seed delivery method used at the TBCC. The relatively large uncertainty in seed placement in this direction is expected, as this is the direction of needle insertion. Further work will involve evaluating deflections of delivered needle tracks from their planned positions.« less

Pedicle screw loosening is correlated to chronic subclinical deep implant infection: a retrospective database analysis.

PubMed

Leitner, Lukas; Malaj, Isabella; Sadoghi, Patrick; Amerstorfer, Florian; Glehr, Mathias; Vander, Klaus; Leithner, Andreas; Radl, Roman

2018-04-13

Spinal fusion is used for treatment of spinal deformities, degeneration, infection, malignancy, and trauma. Reduction of motion enables osseous fusion and permanent stabilization of segments, compromised by loosening of the pedicle screws (PS). Deep implant infection, biomechanical, and chemical mechanisms are suspected reasons for loosening of PS. Study objective was to investigate the frequency and impact of deep implant infection on PS loosening. Intraoperative infection screening from wound and explanted material sonication was performed during revision surgeries following dorsal stabilization. Case history events and factors, which might promote implant infections, were included in this retrospective survey. 110 cases of spinal metal explantation were included. In 29.1% of revision cases, infection screening identified a germ, most commonly Staphylococcus (53.1%) and Propionibacterium (40.6%) genus. Patients screened positive had a significant higher number of previous spinal operations and radiologic loosening of screws. Patients revised for adjacent segment failure had a significantly lower rate of positive infection screening than patients revised for directly implant associated reasons. Removal of implants that revealed positive screening effected significant pain relief. Chronic implant infection seems to play a role in PS loosening and ongoing pain, causing revision surgery after spinal fusion. Screw loosening and multiple prior spinal operations should be suspicious for implant infection after spinal fusion when it comes to revision surgery. These slides can be retrieved under Electronic Supplementary Material.

Implant-retained overdentures for young children with severe oligodontia: a series of four cases.

PubMed

Filius, Marieke A P; Vissink, Arjan; Raghoebar, Gerry M; Visser, Anita

2014-09-01

The treatment need is high in children with severe oligodontia and anodontia, because they often have functional and esthetic problems owing to missing teeth. Because the intraforaminal region barely grows after eruption of the permanent mandibular incisors, dental implant treatment should be considered a treatment option for these children. The purpose of our study was to assess the treatment outcomes regarding satisfaction and the care and aftercare of implant-retained mandibular overdentures in a series of 4 young children without erupted mandibular teeth from either severe oligodontia (n = 3) or anodontia (n = 1). Four children without erupted mandibular teeth, aged 6 to 13 years, were provided with an implant-retained overdenture on 2 implants. The surgical and prosthetic care and aftercare were scored by the clinicians. Also, the patients and their parents were queried about how satisfied they were with the overdenture. The median follow-up of the patients was 5.2 years (range 3.2 to 8.4). No implants were lost, no cases of peri-implantitis occurred, and the need for treatment and aftercare was low. Patient and parent satisfaction with this treatment was high. A 2-implant, retained overdenture in children with no erupted mandibular teeth is a safe treatment modality when appropriate treatment and aftercare can be provided. Copyright © 2014 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Treatment of congenital tracheal stenosis by balloon-expandable metallic stents in paediatric intensive care unit

PubMed Central

Xu, Xuan; Li, Dandan; Zhao, Shuyu; Liu, Xicheng; Feng, Zhichun; Ding, Hui

2012-01-01

The aim of this study was to evaluate the use of balloon-expandable metallic stents in the treatment of children with congenital tracheal stenosis in whom conventional therapy has failed. From 2010 to 2011, balloon-expandable metallic stents were implanted into the trachea of eight infants aged 2–20 months in the paediatric intensive care unit. The infants had severe airway obstruction caused by congenital tracheal stenosis. Tracheal stents were placed after intraluminal balloon dilatation of the tracheal stenosis, inserted with balloon catheters and implanted into the desired position bronchoscopically. The stents were 12 to 29 mm long and 4 mm in diameter. Seven children were relieved of airway obstruction after this procedure. However, a child died due to severe sepsis after the placement of bronchial stents. No granulation tissue developed over the stents in any of the children. Stents have been in place for 1–6 months after insertion without any other complication. Balloon-expandable metallic stents are effective in relieving airway obstruction by congenital tracheal stenosis in children. This technique may provide an important remedy for congenital tracheal stenosis in children. PMID:22361127

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.

Concrescence of permanent maxillary second and third molars: case report of non-surgical root canal treatment.

PubMed

Foran, Denise; Komabayashi, Takashi; Lin, Louis M

2012-03-01

Concrescence is a rare developmental anomaly with an overall incidence of 0.8% in the permanent dentition. While many case reports describe the treatment of concrescence with extraction, there are few reports of non-surgical root canal treatment (NSRCT), due to the atypical root form, canal morphology, and technical difficulties involved in concrescence. This unique case report describes a technical modification of NSRCT that can retain joined posterior maxillary teeth to maintain natural posterior occlusion without surgical intervention or dental implants, thereby avoiding the risk of damage to a large portion of the alveolar bone near the maxillary sinus.

Report on the Clinical Outcomes of Permanent Breast Seed Implant for Early-Stage Breast Cancers

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

Pignol, Jean-Philippe, E-mail: j.p.pignol@erasmusmc.nl; Radiation Oncology Department, Erasmus Medical Center Cancer Institute, Rotterdam; Caudrelier, Jean-Michel

Purpose: Permanent breast seed implant is an accelerated partial breast irradiation technique realizing the insertion of {sup 103}Pd seeds in the seroma after lumpectomy. We report the 5-year efficacy and tolerance for a cohort, pooling patients from 3 clinical trials. Methods and Materials: The trials accrued postmenopausal patients with infiltrating ductal carcinoma or ductal carcinoma in situ ≤3 cm and clear surgical margins, who were node negative, and had a planning target volume <120 cm{sup 3}. The outcomes included overall and disease-free survival and local and contralateral recurrence at 5 years. The true local recurrence rate was compared using 2-tailed paired t testsmore » for estimates calculated using the Tufts University ipsilateral breast tumor recurrence and Memorial Sloan Kettering ductal carcinoma in situ nomograms. Results: The cohort included 134 patients, and the observed local recurrence rate at a median follow-up period of 63 months was 1.2% ± 1.2%, similar to the estimate for whole breast irradiation (P=.23), significantly better than for surgery alone (relative risk 0.27; P<.001), and significantly lower than contralateral recurrence (relative risk 0.33; P<.001). The 5-year overall survival rate was 97.4% ± 1.9%, and the disease-free survival rate was 96.4% ± 2.1%. At 2 months, 42% of the patients had erythema, 20% induration, and 16% moist desquamation. The rate of mainly grade 1 telangiectasia was 22.4% at 2 years and 24% at 5 years. The rate of asymptomatic induration was 23% at 2 years and 40% at 5 years. Conclusions: The 5-year data suggest that permanent breast seed implantation is a safe accelerated partial breast irradiation option after lumpectomy for early-stage breast cancer with a tolerance profile similar to that of whole breast irradiation.« less

SU-F-BRA-03: Integrating Novel Electromagnetic Tracking Hollow Needle Assistance in Permanent Implant Brachytherapy Procedures

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

Racine, E; Hautvast, G; Binnekamp, D

Purpose: To report on the results of a complete permanent implant brachytherapy procedure assisted by an electromagnetic (EM) hollow needle possessing both 3D tracking and seed drop detection abilities. Methods: End-to-end in-phantom EM-assisted LDR procedures were conducted. The novel system consisted of an EM tracking apparatus (NDI Aurora V2, Planar Field Generator), a 3D US scanner (Philips CX50), a hollow needle prototype allowing 3D tracking and seed drop detection and a specially designed treatment planning software (Philips Healthcare). A tungsten-doped 30 cc spherical agarose prostate immersed in gelatin was used for the treatment. A cylindrical shape of 0.8 cc wasmore » carved along its diameter to mimic the urethra. An initial plan of 26 needles and 47 seeds was established with the system. The plan was delivered with the EM-tracked hollow needle, and individual seed drop locations were recorded on the fly. The phantom was subsequently imaged with a CT scanner from which seed positions and contour definitions were obtained. The DVHs were then independently recomputed and compared with those produced by the planning system, both before and after the treatment. Results: Of the 47 seeds, 45 (96%) were detected by the EM technology embedded in the hollow needle design. The executed plan (from CT analysis) differed from the initial plan by 2%, 14% and 8% respectively in terms of V100, D90 and V150 for the prostate, and by 8%, 7% and 10% respectively in terms of D5, V100 and V120 for the urethra. Conclusion: The average DVH deviations between initial and executed plans were within a 5% tolerance imposed for this proof-of-concept assessment. This relatively good concordance demonstrates the feasibility and potential benefits of combining EM tracking and seed drop detection for real-time dosimetry validation and assistance in permanent implant brachytherapy procedures. This project has been entirely funded by Philips Healthcare.« less

Enhanced osseointegration of titanium implants in a rat model of osteoporosis using multilayer bone mesenchymal stem cell sheets

PubMed Central

Duan, Yan; Ma, Wei; Li, Dehua; Wang, Tongfei; Liu, Baolin

2017-01-01

The present study aimed to investigate whether bone marrow-derived mesenchymal stem cell (BMSC) sheets combined with titanium implants enhanced implant osseointegration in an ovariectomized (OVX) rat model of osteoporosis. Sprague-Dawley rats were randomly assigned into a test group and control group. Allogenic BMSCs were collected from the rats, cultured and stored via cryopreservation. At 6 months post-ovariectomy, establishment of the OVX model was confirmed by micro-computed tomography (CT) measurements. BMSC sheets were subsequently layered and wrapped over titanium implants for implantation. Unmodified implants served as the control. At 8 weeks post-implantation, samples were observed by micro-CT reconstruction and histomorphometric evaluation. Micro-CT reconstruction identified a marked improvement in the surrounding bone volume following treatment, with data analyses indicating a significant increase in bone volume in the BMSC-implant group compared with the control implant group (P<0.05). In addition, histological staining identified new bone formation and an increased rate of bone-implant contact surrounding the BMSC-implant constructs. These results indicate that the use of BMSC sheets as a novel tissue engineering approach improves the osseointegration of titanium implants in an osteoporosis model. This method may expand the operative indications in patients with osteoporosis and improve the success rate of clinical dental implant treatments. PMID:29250137

A Review on the Wettability of Dental Implant Surfaces II: Biological and Clinical Aspects

PubMed Central

Gittens, Rolando A.; Scheideler, Lutz; Rupp, Frank; Hyzy, Sharon L.; Geis-Gerstorfer, Jürgen; Schwartz, Zvi; Boyan, Barbara D.

2014-01-01

Dental and orthopaedic implants have been under continuous advancement to improve their interactions with bone and ensure a successful outcome for patients. Surface characteristics such as surface topography and surface chemistry can serve as design tools to enhance the biological response around the implant, with in vitro, in vivo and clinical studies confirming their effects. However, the comprehensive design of implants to promote early and long-term osseointegration requires a better understanding of the role of surface wettability and the mechanisms by which it affects the surrounding biological environment. This review provides a general overview of the available information about the contact angle values of experimental and of marketed implant surfaces, some of the techniques used to modify surface wettability of implants, and results from in vitro and clinical studies. We aim to expand the current understanding on the role of wettability of metallic implants at their interface with blood and the biological milieu, as well as with bacteria, and hard and soft tissues. PMID:24709541

Informed Consent in Implantable BCI Research: Identifying Risks and Exploring Meaning.

PubMed

Klein, Eran

2016-10-01

Implantable brain-computer interface (BCI) technology is an expanding area of engineering research now moving into clinical application. Ensuring meaningful informed consent in implantable BCI research is an ethical imperative. The emerging and rapidly evolving nature of implantable BCI research makes identification of risks, a critical component of informed consent, a challenge. In this paper, 6 core risk domains relevant to implantable BCI research are identified-short and long term safety, cognitive and communicative impairment, inappropriate expectations, involuntariness, affective impairment, and privacy and security. Work in deep brain stimulation provides a useful starting point for understanding this core set of risks in implantable BCI. Three further risk domains-risks pertaining to identity, agency, and stigma-are identified. These risks are not typically part of formalized consent processes. It is important as informed consent practices are further developed for implantable BCI research that attention be paid not just to disclosing core research risks but exploring the meaning of BCI research with potential participants.

Mucosal Perfusion Preservation by a Novel Shapeable Tissue Expander for Oral Reconstruction

PubMed Central

Barwinska, Daria; Garner, John; Davidson, Darrell D.; Cook, Todd G.; Eckert, George J.; Tholpady, Sunil S.; March, Keith L.; Park, Kinam

2017-01-01

Background: There are few methods for expanding oral mucosa, and these often cause complications such as tissue necrosis and expander eruption. This study examines mucosal blood perfusion following insertion of a novel shapeable hydrogel tissue expander (HTE). The canine model used subgingival insertion of HTE following tooth extraction and alveolar bone reduction. The primary goal of this study was to gain understanding of epithelial perfusion and reparative responses of gingival mucosa during HTE expansion. Methods: Nine Beagle dogs underwent bilateral premolar maxillary and mandibular tooth extraction. Three to four months later, HTE-contoured inserts were implanted submucosally under the buccal surface of the alveolar ridge. After removal and following a 6- to 7-month period of healing, new HTE implants were inserted at the same sites. The area was assessed weekly for tissue perfusion and volume of expansion. Biopsies for histological analysis were performed at the time of expander removal. Results: Within 2 weeks following the second insertion, blood flow returned to baseline (defined as the values of perfusion measurements at the presurgery assessment) and remained normal until hydrogel full expansion and removal. Volume expansion analysis revealed that the hydrogel doubled in volume. Histological assessment showed no macrophage or inflammatory infiltration of the mucosa. No superficial fibrosis, decreased vascularity, or mucosal change was seen. Conclusion: Maintenance of adequate tissue perfusion is a clinically important aspect of tissue expander performance to reduce risk of device loss or injury to the patient, particularly for areas with a history of previous surgeries. PMID:28894668

[Radiological trap and oncological precautions in a patient who has undergone a permanent withdrawal of PIP breast implants].

PubMed

Koutsomanis, A; Bruant-Rodier, C; Roedlich, M-N; Bretz-Grenier, M-F; Perrot, P; Bodin, F

2015-12-01

We report the case of a 57-year-old patient who presented radiological images similar to ruptured breast implants one year after the supposed withdrawal of the latter. This woman had benefited for the first time from cosmetic PIP breast implants in 2000. Early in 2014, she requested the removal of the implants without renewal because she was feeling pain and functional discomfort. A few months after the operation, she consulted for breast swelling in the upper pole of the breast. Radiological assessment showed liquid formations compatible with the presence of implants. At our request, the rereading of the MRI by the radiologist definitively concluded on a bilateral seroma within the persistent fibrous capsule. In the absence of symptoms, clinical monitoring had been decided. But at the recrudescence of anaplastic large cell lymphoma cases associated with breast implants, a cytological sampling was intended. In case of cytological abnormality or recurrence of the seroma, a surgical procedure should be performed. In conclusion, the removal of a breast implant without capsulectomy may result in the formation of a seroma whose images resemble those of an implant. It is always worthwhile to provide precise clinical data to the radiologist in order to help him to make informed interpretations. Every serous effusion in a breast lodge having contained a silicone implant must evoke the diagnosis of anaplastic large cell lymphoma. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Transcatheter Aortic Valve Implantation: Experience with the CoreValve Device.

PubMed

Asgar, Anita W; Bonan, Raoul

2012-01-01

The field of transcatheter aortic valve implantation has been rapidly evolving. The Medtronic CoreValve first emerged on the landscape in 2004 with initial first human studies, and it is currently being studied in the Pivotal US trial. This article details the current experience with the self-expanding aortic valve with a focus on clinical results and ongoing challenges. Copyright © 2012 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.

In-Graft Endovascular Stenting Repair for Supravalvular Stenosis From Aortic Rupture After Balloon-Expanding Transcatheter Aortic Valve Implantation.

PubMed

Furukawa, Nobuyuki; Scholtz, Werner; Haas, Nikolaus; Ensminger, Stephan; Gummert, Jan; Börgermann, Jochen

2015-01-01

An 81-year-old man with high-grade aortic valve stenosis and status post-coronary artery bypass grafting and supracoronary replacement of the ascending aorta was referred for transcatheter aortic valve implantation. He was in New York Heart Association class III and had dyspnea. After appropriate screening, we implanted a 29-mm SAPIEN XT valve (Edwards Lifesciences, Irvine, CA USA) through a transapical approach because of severe peripheral arterial occlusive disease. Postinterventional aortography revealed correct positioning and function of the valve and free coronary ostia but contrast extravasation in the vicinity of the interposed vascular prosthesis, resulting in severe luminal narrowing. We chose to manage the stenosis with an endovascular stent. After stenting, extravascular compression was markedly reduced, and the pressure gradient disappeared. The patient was discharged home on the 20th postoperative day. Three months later, computed tomography depicted correct positioning of both grafts. The patient's general health is good, and he is now in New York Heart Association class II. This case illustrates a complication of transcatheter aortic valve implantation specific for patients with an ascending aortic graft. Although stenting may be a good solution, as depicted by this case, self-expanding transcatheter aortic valves should be preferred in patients with ascending aortic grafts to avoid the described complication.

A Mini Axial and a Permanent Maglev Radial Heart Pump§

PubMed Central

Qian, Kun-Xi; Ru, Wei-Min; Wang, Hao; Jing, Teng

2007-01-01

The implantability and durability have been for decades the focus of artificial heart R&D. A mini axial and a maglev radial pump have been developed to meet with such requirements. The mini axial pump weighing 27g (incl.5g rotor) has an outer diameter of 21mm and a length of 10mm in its largest point, but can produce a maximal blood flow of 6l/min with 50mmHg pressure increase. Therefore, it is suitable for the patients of 40-60kg body weight. For other patients of 60-80kg or 80-100kg body weight, the mini axial pumps of 23mm and 25mm outer diameter had been developed before, these devices were acknowledged to be the world smallest LVADs by Guinness World Record Center in 2004. The permanent maglev radial pump weighing 150g is a shaft-less centrifugal pump with permanent magnetic bearings developed by the author. It needs no second coil for suspension of the rotor except the motor coil, different from all other maglev pumps developed in USA, Japan, European, etc. Thus no detecting and controlling systems as well as no additional power supply for maglev are necessary. The pump can produce a blood flow up to as large as 10l/min against 100mmHg pressure. An implantable and durable blood pump will be a viable alternative to natural donor heart for transplantation. PMID:19662120

Design and logistics of integrated spacecraft/lander lunar habitat concepts

NASA Technical Reports Server (NTRS)

Hypes, Warren D.; Wright, Robert L.; Gould, Marston J.; Lovelace, U. M.

1991-01-01

Integrated spacecraft/lander combinations have been designed to provide a support structure for thermal and galactic radiation shielding for three initial lunar habitat concepts. Integrating the support structure with the habitat reduces the logistics requirements for the implantation of the initial base. The designs are simple, make use of existing technologies, and minimize the amount of lunar surface preparation and crew activity. The design facilitates continued use of all elements in the development of a permanent lunar base and precludes the need for an entirely different structure of larger volume and increased complexity of implantation. This design philosophy, coupled with the reduced logistics, increases overall cost effectiveness.

Feeding-associated alterations in striatal neurotransmitter release

NASA Technical Reports Server (NTRS)

Acworth, I. N.; Ressler, K.; Wurtman, R. J.

1989-01-01

Published evidence suggests a role for dopaminergic (DA) brain pathways in feeding-associated behaviors. Using the novel technique of brain microdialysis of striatal extracellular fluid (ECF) as an index of DA release, Church et al. described increases in levels of DA when animals had limited access to pellets, but not with free access. Dopamine release from the nucleus accumbens did increase with free access to pellets post starvation or after food reward. We used permanently implanted microdialysis probes to measure ECF levels of DA, DOPAC, HVA, and large neutral amino acids (LNAA) for up to 72 hours after implantation among rats experiencing different dietary regimens.

Medial subclavicular musculotendinous complex and insulation break: Rare cause of late pacemaker lead malfunction

PubMed Central

Bhattacharyya, Pranab Jyoti; Agrawal, Shweta; Barkataky, Jogesh Chandra; Bhattacharyya, Anjan Kumar

2015-01-01

Insulation break in a permanent pacemaker lead is a rare long-term complication. We describe an elderly male with a VVIR pacemaker, who presented with an episode of presyncope more than 3 years after the initial implantation procedure, attributed to insulation break possibly caused by lead entrapment in components of the medial subclavicular musculotendinous complex (MSMC) and repeated compressive damage over time during ipsilateral arm movement requiring lead replacement. The differential diagnosis of a clinical presentation when pacing stimuli are present with failure to capture and the role of the MSMC in causing lead damage late after implantation are discussed. PMID:26995445

Cost analysis of postmastectomy reconstruction: A comparison of two staged implant reconstruction using tissue expander and acellular dermal matrix with abdominal-based perforator free flaps.

PubMed

Tran, Bao Ngoc N; Fadayomi, Ayotunde; Lin, Samuel J; Singhal, Dhruv; Lee, Bernard T

2017-09-01

Two staged tissue expander-implant with acellular dermal matrix (TE/I + ADM) and deep inferior epigastric perforator (DIEP) flap are the most common implant and autologous methods of reconstruction in the U.S. Implant-based techniques are disproportionally more popular, partially due to its presumed cost effectiveness. We performed a comprehensive cost analysis to compare TE/I + ADM and DIEP flap. A comparative cost analysis of TE/I + ADM and DIEP flap was performed. Medicare reimbursement costs for each procedure and their associated complications were calculated. Pooled probabilities of complications including cellulitis, seroma, skin necrosis, implant removal, flap loss, partial flap loss, and fat necrosis, were calculated using published studies from 2010 to 2016. Average actual cost for successful TE/I + ADM and DIEP flap were $13 304.55 and $10 237.13, respectively. Incorporating pooled complication data from published literature resulted in an increase in cost to $13 963.46 for TE/I + ADM and $12 624.29 for DIEP flap. The expected costs for successful TE/I + ADM and DIEP flap were $9700.35 and $8644.23, which are lower than the actual costs. DIEP flap breast reconstruction incurs lower costs compared to TE/I + ADM. These costs are lower at baseline and when additional costs from pooled complications are incorporated. © 2017 Wiley Periodicals, Inc.

Stent Polymers: Do They Make a Difference?

PubMed

Rizas, Konstantinos D; Mehilli, Julinda

2016-06-01

The necessity of polymers on drug-eluting stent (DES) platforms is dictated by the need of an adequate amount and optimal release kinetic of the antiproliferative drugs for achieving ideal DES performance. However, the chronic vessel wall inflammation related to permanent polymer persistence after the drug has been eluted might trigger late restenosis and stent thrombosis. Biodegradable polymers have the potential to avoid these adverse events. A variety of biodegradable polymer DES platforms have been clinically tested, showing equal outcomes with the standard-bearer permanent polymer DES within the first year of implantation. At longer-term follow-up, promising lower rates of stent thrombosis have been observed with the early generation biodegradable polymer DES platforms compared to first-generation DES. Whether this safety benefit still persists with newer biodegradable polymer DES generations against second-generation permanent polymer DES needs to be explored. © 2016 American Heart Association, Inc.

Using the Minimally Invasive Impella 5.0 via the Right Subclavian Artery Cutdown for Acute on Chronic Decompensated Heart Failure as a Bridge to Decision.

PubMed

Bansal, Aditya; Bhama, Jay K; Patel, Rajan; Desai, Sapna; Mandras, Stacy A; Patel, Hamang; Collins, Tyrone; Reilly, John P; Ventura, Hector O; Parrino, P Eugene

2016-01-01

Outcomes of traditional mechanical support paradigms (extracorporeal membrane oxygenation, intraaortic balloon pump [IABP], and permanent left ventricular assist device [LVAD]) in acute decompensated heart failure have generally been suboptimal. Novel approaches, such as minimally invasive LVAD therapy (Impella 5.0 device), promise less invasive but equivalent hemodynamic support. However, it is yet unknown whether the outcomes with such devices support widespread acceptance of this new technology. We recently started utilizing the right subclavian artery (RSA) for Impella 5.0 implantation and report our early experience and outcomes with this novel approach. A single-center retrospective review was performed of 24 patients with acute on chronic decompensated heart failure who received the Impella 5.0 via the RSA from June 2011 to May 2014. The device was implanted via a cutdown through an 8-mm vascular graft sewn to the RSA. The device was positioned with fluoroscopy and transesophageal echocardiography. The mean age of the patients was 51.29 years, and 75% were male. At implantation, all patients were mechanically ventilated on at least 2 inotropes with persistent cardiogenic shock, and 17 (70.8%) were on IABP support. Postimplantation, 21 (87.5%) tolerated extubation, and all 17 of the patients with IABPs tolerated discontinuation of IABP support. The reduction in the Model for End-Stage Liver Disease score preimplantation vs postimplantation was statistically significant (21.17 vs 14.88, P=0.0014), suggesting improvement in end organ function. A significant decrease was also seen in creatinine levels before and after implantation (2.17 mg/dL vs 1.50 mg/dL, P=0.0043). The endpoint of support included recovery in 6 patients (25.0%), permanent LVAD in 9 (37.5%), and heart transplantation in 2 (8.3%). Death occurred in 7 patients (29.2%) as a result of multisystem organ failure, infection, or patient withdrawal of care. Minimally invasive LVAD therapy using the Impella 5.0 via the RSA cutdown is an attractive option in acute on chronic decompensated heart failure. Improvement in end organ function allows for transition to recovery or to advanced surgical therapies such as permanent LVAD and heart transplantation. Significant advantages to this approach include improved left ventricular unloading, lower anticoagulation need, and the potential for ambulation and physical therapy.

Using the Minimally Invasive Impella 5.0 via the Right Subclavian Artery Cutdown for Acute on Chronic Decompensated Heart Failure as a Bridge to Decision

PubMed Central

Bansal, Aditya; Bhama, Jay K.; Patel, Rajan; Desai, Sapna; Mandras, Stacy A.; Patel, Hamang; Collins, Tyrone; Reilly, John P.; Ventura, Hector O.; Parrino, P. Eugene

2016-01-01

Background: Outcomes of traditional mechanical support paradigms (extracorporeal membrane oxygenation, intraaortic balloon pump [IABP], and permanent left ventricular assist device [LVAD]) in acute decompensated heart failure have generally been suboptimal. Novel approaches, such as minimally invasive LVAD therapy (Impella 5.0 device), promise less invasive but equivalent hemodynamic support. However, it is yet unknown whether the outcomes with such devices support widespread acceptance of this new technology. We recently started utilizing the right subclavian artery (RSA) for Impella 5.0 implantation and report our early experience and outcomes with this novel approach. Methods: A single-center retrospective review was performed of 24 patients with acute on chronic decompensated heart failure who received the Impella 5.0 via the RSA from June 2011 to May 2014. The device was implanted via a cutdown through an 8-mm vascular graft sewn to the RSA. The device was positioned with fluoroscopy and transesophageal echocardiography. Results: The mean age of the patients was 51.29 years, and 75% were male. At implantation, all patients were mechanically ventilated on at least 2 inotropes with persistent cardiogenic shock, and 17 (70.8%) were on IABP support. Postimplantation, 21 (87.5%) tolerated extubation, and all 17 of the patients with IABPs tolerated discontinuation of IABP support. The reduction in the Model for End-Stage Liver Disease score preimplantation vs postimplantation was statistically significant (21.17 vs 14.88, P=0.0014), suggesting improvement in end organ function. A significant decrease was also seen in creatinine levels before and after implantation (2.17 mg/dL vs 1.50 mg/dL, P=0.0043). The endpoint of support included recovery in 6 patients (25.0%), permanent LVAD in 9 (37.5%), and heart transplantation in 2 (8.3%). Death occurred in 7 patients (29.2%) as a result of multisystem organ failure, infection, or patient withdrawal of care. Conclusion: Minimally invasive LVAD therapy using the Impella 5.0 via the RSA cutdown is an attractive option in acute on chronic decompensated heart failure. Improvement in end organ function allows for transition to recovery or to advanced surgical therapies such as permanent LVAD and heart transplantation. Significant advantages to this approach include improved left ventricular unloading, lower anticoagulation need, and the potential for ambulation and physical therapy. PMID:27660567

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

High activity iodine 125 endocurietherapy for recurrent skull base tumors

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

Kumar, P.P.; Good, R.R.; Leibrock, L.G.

1988-04-15

Experience with endocurietherapy of skull base tumors is reviewed. We present our cases of recurrent pituitary hemangiopericytoma, radiation-induced recurrent meningioma, recurrent clival chordoma, recurrent nasopharyngeal cancer involving the cavernous sinus, and recurrent parotid carcinoma of the skull base which were all successfully retreated with high-activity 125-iodine (I-125) permanent implantation.76 references.

Periodontal and peri-implant bone regeneration: clinical and histologic observations.

PubMed

Artzi, Z; Zohar, R; Tal, H

1997-02-01

The principle of guided tissue regeneration by barrier membranes to restore lost periodontal tissue around natural teeth has also been used around osseointegrated implants in an attempt to restore alveolar ridge defects. While most periodontal procedures in the literature describe root coverage by mucogingival surgery, which achieves healing through soft tissue attachment, regeneration of denuded root surfaces is performed by guided tissue regeneration using expanded polytetrafluoroethylene barrier membranes and demineralized freeze-dried bone allografts as inductive/conductive materials. In this study the technique is applied in two partially exposed cylindrical hydroxyapatite-coated implants in extraction sites in one patient. Surgical reentry in both sites is presented, with histologic examination revealing new bone formation on the exposed root surface and the hydroxyapatite-coated implants.

[Expandable metal mesh stents for treatment of tracheal stenoses and tracheomalacia].

PubMed

Müller, C; Dienemann, H; Hoffmann, H; Berger, H; Storck, M; Jolk, A; Schildberg, F W

1993-01-01

The treatment of tracheo-bronchial stenosis or tracheomalacia is mainly carried out by means of resection or tracheoplastic operative strategies. Since the introduction of metal-mesh stents, a definitive endoluminal therapy has to be considered under new aspects. Six patients with malignant stenosis or tracheomalacia due to compression were treated by implantation of Palmaz- or Wallstents. Immediately after the implantation, patients were relieved from dyspnoea, the forced inspiratory volume-1 (FIV1) was normalized. All implanted stents were well tolerated, even in the long-time follow-up (19 months). Bronchoscopic control showed overgrowth of the metal meshes by respiratory epithelium. The implantation of metal-mesh stents is an adequate alternative in the treatment of malignant stenosis and tracheomalacia.

Surface modification of traditional and bioresorbable metallic implant materials for improved biocompatibility

NASA Astrophysics Data System (ADS)

Walker, Emily K.

Due to their strength, elasticity, and durability, a variety of metal alloys are commonly used in medical implants. Traditionally, corrosion-resistant metals have been preferred. These permanent materials can cause negative systemic and local tissue effects in the long-term. Permanent stenting can lead to late-stent thrombosis and in-stent restenosis. Metallic pins and screws for fracture fixation can corrode and fail, cause loss of bone mass, and contribute to inflammation and pain at the implant site, requiring reintervention. Corrodible metallic implants have the potential to prevent many of these complications by providing transient support to the affected tissue, dissolving at a rate congruent with the healing of the tissue. Alloys of iron and manganese (FeMn) exhibit similar fatigue strength, toughness, and elasticity compared with 316L stainless steel, making them very attractive candidates for bioresorbable stents and temporary fracture fixation devices. Much attention in recent years has been given to creating alloys with ideal mechanical properties for various applications. Little work has been done on determining the blood compatibility of these materials or on examining how their surfaces can be improved to improve cell adhesion, however. We examined thethrombogenic response of blood exposed to various resorbable ferrous stent materials through contact with porcine blood. The resorbable materials induced comparable or lower levels of several coagulation factors compared with 316L stainless steel. Little platelet adhesion was observed on any of the tested materials. Endothelialization is an important process after the implantation of a vascular stent, as it prevents damage to the vessel wall that can accelerate neointimal hyperplasia. Micromotion can lead to the formation of fibrous tissue surrounding an orthopedic implant, loosening, and ultimately failure of the implant. Nanoscale features were created on the surfaces of noble metal coatings, silicon, and bioabsorbable materials through ion beam irradiation in order to improve endothelialzation and bone cell adhesion. Gold, palladium, silicon, and iron manganese surfaces were patterned through ion beam irradiation using argon ions. The surface morphology of the samples was examined using atomic force microscopy (AFM) and scanning electron microscopy (SEM), while surface chemistry was examined through x-ray photoelectron spectroscopy (XPS) and contact angle goniometry measurements. It was not possible to create nanoscale surface features on the surfaces of the gold and palladium films. At near normal incidence, irradiation produced ripples on the surfaces of Si(100), while oblique incidence irradiation produced nanoislands in the presence of impurities on the surface. Iron manganese irradiation resulted in the formation of blade-shaped structures for ion energies between 500eV and 1000eV, and significant iron enrichment at the surface. Chemical treatment can also be used to create surface features that will enhance cell adhesion. Ti6Al4V is one of the most commonly used alloys for permanent orthopedic devices. The creation of a porous surface in order to improve osteoblast adhesion was achieved through chemical etching using acid-peroxide solutions. While phosphoric acid etched the grain boundaries, sulfuric and nitric acid preferentially etched grains of particular orientations, creating a spongy, porous morphology that has the potential to aid in osseointegration.

Expandable Polyaryl-Ether-Ether-Ketone Spacers for Interbody Distraction in the Lumbar Spine

PubMed Central

Alimi, Marjan; Shin, Benjamin; Macielak, Michael; Hofstetter, Christoph P.; Njoku, Innocent; Tsiouris, Apostolos J.; Elowitz, Eric; Härtl, Roger

2015-01-01

Study Design Retrospective case series. Objective StaXx XD (Spine Wave, Inc., Shelton, CT, United States) is an expandable polyaryl-ether-ether-ketone (PEEK) wafer implant utilized in the treatment of lumbar degenerative disease. PEEK implants have been successfully used as interbody devices. Few studies have focused on expandable PEEK devices. The aim of the current study is to determine the radiographic and clinical outcome of expandable PEEK cages utilized for transforaminal lumbar interbody fusion in patients with lumbar degenerative diseases. Methods Forty-nine patients who underwent lumbar interbody fusion with implantation of expandable PEEK cages and posterior instrumentation were included. The clinical outcome was evaluated using the visual analog scale (VAS) and the Oswestry Disability Index (ODI). Radiographic parameters including disk height, foraminal height, listhesis, local disk angle of the index level/levels, regional lumbar lordosis, and graft subsidence were measured preoperatively, postoperatively, and at latest follow-up. Results At an average follow-up of 19.3 months, the minimum clinically important difference for the ODI and VAS back, buttock, and leg were achieved in 64, 52, 58, and 52% of the patients, respectively. There was statistically significant improvement in VAS back (6.42 versus 3.11, p < 0.001), VAS buttock (4.66 versus 1.97, p = 0.002), VAS leg (4.55 versus 1.96, p < 0.001), and ODI (21.7 versus 12.1, p < 0.001) scores. There was a significant increase in the average disk height (6.49 versus 8.18 mm, p = 0.037) and foraminal height (15.6 versus 18.53 mm, p = 0.0001), and a significant reduction in the listhesis (5.13 versus 3.15 mm, p = 0.005). The subsidence of 0.66 mm (7.4%) observed at the latest follow-up was not significant (p = 0.35). Conclusions Midterm results indicate that expandable PEEK spacers can effectively and durably restore disk and foraminal height and improve the outcome without significant subsidence. PMID:26131383

Optimizing Results of Postmastectomy Radiation Therapy Utilizing the Latissimus Dorsi Flap and Tissue Expander Technique: A Single-Center Experience

PubMed Central

Chevrollier, Guillaume S.; Greaney, Patrick J.; Jenkins, Matthew P.; Copit, Steven E.

2017-01-01

Objective: Postmastectomy radiation therapy is a well-established risk factor for complications after breast reconstruction. Even if the surgeon has a suspicion that radiation therapy may be needed, it may be beneficial to place tissue expanders during the mastectomy procedure as a temporizing measure, complete radiation therapy, and then reconstruct the breast with a latissimus flap. The purpose of this study was to examine the complication rates of the latissimus dorsi flap as compared with the complication rates of implant-based reconstruction in the setting of radiation therapy. Methods: A 16-year retrospective chart review from 2000 to 2016 was conducted. All patients who underwent temporizing tissue expander placement for radiotherapy with subsequent latissimus flap reconstruction were included in the study. Patients who did not follow up for implant exchange were excluded from the study. Results: Fifty-five patients were identified with an average age of 46.0 years (range, 27-67 years) and an average body mass index of 24.2 (range, 18.9-31.9). Five patients (9.1%) developed capsular contractures amenable to surgical intervention. One patient (1.8%) developed infection of the tissue expander, requiring removal. There were no incidences of flap failure or wound dehiscence. The average follow-up after latissimus flap reconstruction was 25.3 months (range, 3.7-121.6 months). Conclusions: We feel that the latissimus dorsi flap after postmastectomy radiation therapy represents the preferred implant-based reconstruction option to consider when the need for postmastectomy radiation therapy is anticipated. The latissimus dorsi flap remains a safe, effective solution to postmastectomy radiation therapy that every plastic surgeon should offer. PMID:29308108

Optimizing Results of Postmastectomy Radiation Therapy Utilizing the Latissimus Dorsi Flap and Tissue Expander Technique: A Single-Center Experience.

PubMed

Mohiuddin, Waseem; Chevrollier, Guillaume S; Greaney, Patrick J; Jenkins, Matthew P; Copit, Steven E

2017-01-01

Objective: Postmastectomy radiation therapy is a well-established risk factor for complications after breast reconstruction. Even if the surgeon has a suspicion that radiation therapy may be needed, it may be beneficial to place tissue expanders during the mastectomy procedure as a temporizing measure, complete radiation therapy, and then reconstruct the breast with a latissimus flap. The purpose of this study was to examine the complication rates of the latissimus dorsi flap as compared with the complication rates of implant-based reconstruction in the setting of radiation therapy. Methods: A 16-year retrospective chart review from 2000 to 2016 was conducted. All patients who underwent temporizing tissue expander placement for radiotherapy with subsequent latissimus flap reconstruction were included in the study. Patients who did not follow up for implant exchange were excluded from the study. Results: Fifty-five patients were identified with an average age of 46.0 years (range, 27-67 years) and an average body mass index of 24.2 (range, 18.9-31.9). Five patients (9.1%) developed capsular contractures amenable to surgical intervention. One patient (1.8%) developed infection of the tissue expander, requiring removal. There were no incidences of flap failure or wound dehiscence. The average follow-up after latissimus flap reconstruction was 25.3 months (range, 3.7-121.6 months). Conclusions: We feel that the latissimus dorsi flap after postmastectomy radiation therapy represents the preferred implant-based reconstruction option to consider when the need for postmastectomy radiation therapy is anticipated. The latissimus dorsi flap remains a safe, effective solution to postmastectomy radiation therapy that every plastic surgeon should offer.

The road to higher permanence and biodiversity in exurban wetlands.

PubMed

Urban, Mark C; Roehm, Robert

2018-01-01

Exurban areas are expanding throughout the world, yet their effects on local biodiversity remain poorly understood. Wetlands, in particular, face ongoing and substantial threats from exurban development. We predicted that exurbanization would reduce the diversity of wetland amphibian and invertebrate communities and that more spatially aggregated residential development would leave more undisturbed natural land, thereby promoting greater local diversity. Using structural equation models, we tested a series of predictions about the direct and indirect pathways by which exurbanization extent, spatial pattern, and wetland characteristics might affect diversity patterns in 38 wetlands recorded during a growing season. We used redundancy, indicator species, and nested community analyses to evaluate how exurbanization affected species composition. In contrast to expectations, we found higher diversity in exurban wetlands. We also found that housing aggregation did not significantly affect diversity. Exurbanization affected biodiversity indirectly by increasing roads and development, which promoted permanent wetlands with less canopy cover and more aquatic vegetation. These pond characteristics supported greater diversity. However, exurbanization was associated with fewer temporary wetlands and fewer of the species that depend on these habitats. Moreover, the best indicator species for an exurban wetland was the ram's head snail, a common disease vector in disturbed ponds. Overall, results suggest that exurbanization is homogenizing wetlands into more permanent water bodies. These more permanent, exurban ponds support higher overall animal diversity, but exclude temporary wetland specialists. Conserving the full assemblage of wetland species in expanding exurban regions throughout the world will require protecting and creating temporary wetlands.

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.

Compression Molding and Novel Sintering Treatments for Alnico Type-8 Permanent Magnets in Near-Final Shape with Preferred Orientation

NASA Astrophysics Data System (ADS)

Kassen, Aaron G.; White, Emma M. H.; Tang, Wei; Hu, Liangfa; Palasyuk, Andriy; Zhou, Lin; Anderson, Iver E.

2017-09-01

Economic uncertainty in the rare earth (RE) permanent magnet marketplace, as well as in an expanding electric drive vehicle market that favors permanent magnet alternating current synchronous drive motors, motivated renewed research in RE-free permanent magnets like "alnico," an Al-Ni-Co-Fe alloy. Thus, high-pressure, gas-atomized isotropic type-8H pre-alloyed alnico powder was compression molded with a clean burn- out binder to near-final shape and sintered to density >99% of cast alnico 8 (full density of 7.3 g/cm3). To produce aligned sintered alnico magnets for improved energy product and magnetic remanence, uniaxial stress was attempted to promote controlled grain growth, avoiding directional solidification that provides alignment in alnico 9. Successful development of solid-state powder processing may enable anisotropically aligned alnico magnets with enhanced energy density to be mass-produced.

Development of a portable weigh-in-motion system.

DOT National Transportation Integrated Search

2013-03-01

Weigh-In-Motion (WIM) data is used for a variety of roadway design and safety purposes. In compliance with Federal Highway Administration (FHWA) mandates, many states have installed permanent WIM sites to measure vehicle weight. Expanding current sit...

Expanded polytetrafluoroethylene membrane alters tissue response to implanted Ahmed glaucoma valve.

PubMed

DeCroos, Francis Char; Ahmad, Sameer; Kondo, Yuji; Chow, Jessica; Mordes, Daniel; Lee, Maria Regina; Asrani, Sanjay; Allingham, R Rand; Olbrich, Kevin C; Klitzman, Bruce

2009-07-01

Long-term intraocular pressure control by glaucoma drainage implants is compromised by the formation of an avascular fibrous capsule that surrounds the glaucoma implant and increases aqueous outflow resistance. It is possible to alter this fibrotic tissue reaction and produce a more vascularized and potentially more permeable capsule around implanted devices by enclosing them in a porous membrane. Ahmed glaucoma implants modified with an outer 5-microm pore size membrane (termed porous retrofitted implant with modified enclosure or PRIME-Ahmed) and unmodified glaucoma implants were implanted into paired rabbit eyes. After 6 weeks, the devices were explanted and subject to histological analysis. A tissue response containing minimal vascularization, negligible immune response, and a thick fibrous capsule surrounded the unmodified Ahmed glaucoma implant. In comparison, the tissue response around the PRIME-Ahmed demonstrated a thinner fibrous capsule (46.4 +/- 10.8 microm for PRIME-Ahmed versus 94.9 +/- 21.2 microm for control, p < 0.001) and was highly vascularized near the tissue-material interface. A prominent chronic inflammatory response was noted as well. Encapsulating the aqueous outflow pathway with a porous membrane produces a more vascular tissue response and thinner fibrous capsule compared with a standard glaucoma implant plate. Enhanced vascularity and a thinner fibrous capsule may reduce aqueous outflow resistance and improve long-term glaucoma implant performance.

Patients' and procedural characteristics of AV-block during slow pathway modulation for AVNRT-single center 10year experience.

PubMed

Wasmer, Kristina; Dechering, Dirk G; Köbe, Julia; Leitz, Patrick; Frommeyer, Gerrit; Lange, Phillip S; Kochhäuser, Simon; Reinke, Florian; Pott, Christian; Mönnig, Gerold; Breithardt, Günter; Eckardt, Lars

2017-10-01

Permanent AV-block is a recognized and feared complication of slow pathway modulation for AVNRT. We aimed to assess incidence of transient and permanent AV-block as well as consequences of transient AV-block in a large contemporary AVNRT ablation cohort. We searched our single center prospective ablation database for occurrence of transient and permanent AV-block during slow pathway modulation between January 2004 and October 2015. We analyzed patients' and procedural characteristics as well as outcome of patients in whom transient or permanent AV-block occurred. Of 9170 patients who underwent a catheter ablation at our institution between January 2004 and October 2015, 2101 patients (64% women, mean age 50±18years) underwent slow pathway modulation. In three patients, permanent AV-block occurred during RF application. Additional two patients had transient AV-block that recovered (after a few minutes and 25min), but recurred within two days of the procedure. All five patients underwent dual chamber pacemaker implantation (0.2%). Transient AV-block related to RF delivery occurred in 44 patients (2%). Transient mechanical AV-block occurred in additional 17 patients (0.8%). In 12 patients, ablation was continued despite transient AV-block. One of these patients developed permanent AV-block. Permanent AV-block following slow pathway modulation is a rare event, occurring in 0.2% of patients in a large contemporary single center cohort. Transient AV-block is more frequent (2%). Copyright © 2017 Elsevier B.V. All rights reserved.

Connective tissue grafts for thickening peri-implant tissues at implant placement. One-year results from an explanatory split-mouth randomised controlled clinical trial.

PubMed

Wiesner, Günter; Esposito, Marco; Worthington, Helen; Schlee, Markus

2010-01-01

Nothing to declare. To evaluate whether connective tissue grafts performed at implant placement could be effective in augmenting peri-implant soft tissues. Ten partially edentulous patients requiring at least one single implant in the premolar or molar areas of both sides of the mandible were randomised to have one side augmented at implant placement with a connective soft tissue graft harvested from the palate or no augmentation. After 3 months of submerged healing, abutments were placed and within 1 month definitive crowns were permanently cemented. Outcome measures were implant success, any complications, peri-implant marginal bone level changes, patient satisfaction and preference, thickness of the soft tissues and aesthetics (pink aesthetic score) evaluated by an independent and blinded assessor 1 year after loading. One year after loading, no patients dropped out, no implants failed and no complications occurred. Both groups lost statistically significant amounts of peri-implant bone 1 year after loading (0.8 mm in the grafted group and 0.6 mm in the non-grafted group), but there was no statistically significant difference between groups. Soft tissues at augmented sites were 1.3 mm thicker (P < 0.001) and had a significantly better pink aesthetic score (P < 0.001). Patients were highly satisfied (no statistically significant differences between treatments) though they preferred the aesthetics of the augmented sites (P = 0.031). However, five patients would not undergo the grafting procedure again and two were uncertain. Connective tissue grafts are effective in increasing soft tissue thickness, thus improving aesthetics. Longer follow-ups are needed to evaluate the stability of peri-implant tissues over time.

Chondrogenically primed tonsil-derived mesenchymal stem cells encapsulated in riboflavin-induced photocrosslinking collagen-hyaluronic acid hydrogel for meniscus tissue repairs.

PubMed

Koh, Rachel H; Jin, Yinji; Kang, Byung-Jae; Hwang, Nathaniel S

2017-04-15

Current meniscus tissue repairing strategies involve partial or total meniscectomy, followed by allograft transplantation or synthetic material implantation. However, allografts and synthetic implants have major drawbacks such as the limited supply of grafts and lack of integration into host tissue, respectively. In this study, we investigated the effects of conditioned medium (CM) from meniscal fibrochondrocytes and TGF-β3 on tonsil-derived mesenchymal stem cells (T-MSCs) for meniscus tissue engineering. CM-expanded T-MSCs were encapsulated in riboflavin-induced photocrosslinked collagen-hyaluronic acid (COL-RF-HA) hydrogels and cultured in chondrogenic medium containing TGF-β3. In vitro results indicate that CM-expanded cells followed by TGF-β3 exposure stimulated the expression of fibrocartilage-related genes (COL2, SOX9, ACAN, COL1) and production of extracellular matrix components. Histological assessment of in vitro and subcutaneously implanted in vivo constructs demonstrated that CM-expanded cells followed by TGF-β3 exposure resulted in highest cell proliferation, GAG accumulation, and collagen deposition. Furthermore, when implanted into meniscus defect model, CM treatment amplified the potential of TGF-β3 and induced complete regeneration. Conditioned medium derived from chondrocytes have been reported to effectively prime mesenchymal stem cells toward chondrogenic lineage. Type I collagen is the main component of meniscus extracellular matrix and hyaluronic acid is known to promote meniscus regeneration. In this manuscript, we investigated the effects of conditioned medium (CM) and transforming growth factor-β3 (TGF-β3) on tonsil-derived mesenchymal stem cells (T-MSCs) encapsulated in riboflavin-induced photocrosslinked collagen-hyaluronic acid (COL-RF-HA) hydrogel. We employed a novel source of conditioned medium, derived from meniscal fibrochondrocytes. Our in vitro and in vivo results collectively illustrate that CM-expanded cells followed by TGF-β3 exposure have the best potential for meniscus regeneration. This manuscript highlights a novel stem cell commitment strategy combined with biomaterials designs for meniscus regeneration. Copyright © 2017 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.

The future of space - Space tomorrow: The Antarctica model

NASA Technical Reports Server (NTRS)

Beggs, J.

1983-01-01

The exploration and settling of Antarctica with permanent bases are used as illustrative points for establishing a permanent human presence in near-earth space. NASA activities since 1958 have spawned the computer science, solid-state electronics, medical electronics, and communications satellites industries, which are also rapidly expanding in other countries, as are space-faring capabilities. Antarctica is a paradigm for space exploration in that it is hard to reach, hostile to human life, and a great amount of planning is necessary to arrive at the destination and survive. Aircraft made permanent settlements possible on Antarctica, just as the Shuttle does for space. A space station would provide the remote base from which exploration of other planets and settling on the moon could proceed.

[Current requirements for polymeric biomaterials in ear, nose and throat medicine].

PubMed

Sternberg, K

2009-05-01

In recent years the ear, nose and throat medicine (ENT medicine) has been stimulated by numerous innovations in the field of implants which are based on new biomaterials and modern implant technologies. In this context, biomaterials integrated in living organisms have to allow for the technical requirements and the biological interactions between the implant and the tissue. With regard to their suitability, functional capability of the implant, which is complementary to the mechanical implant properties, sufficient stability against physiological media, as well as high biocompatibility are to be demanded. Another purpose of the use of biomaterials is the maintenance and the enhancement of biofunctionality over a long time period. These general requirements for biomaterials also have their validity in ENT medicine. Different materials are applied as biomaterials. Metals belong to the oldest biomaterials. In addition, alloys, ceramics, inorganic glasses and composites were tested. Furthermore, natural and synthetic polymers, which are primarily presented in this article regarding their properties and their applications as materials for cochlear implants, osteosynthesis implants, stents and novel scaffolds for tissue engineering, are increasingly applied. According to their use in permanent and temporary implants, polymers are to be differentiated between biostable and biodegradable polymers. The presented general and current requirements for biomaterials and biomaterial applications in ENT medicine demonstrate key aspects of the current biomaterial research in this field. They do as well document the high impact of the interdisciplinary collaboration of natural and medical scientists and engineers.

Functional and Histological Effects of Chronic Neural Electrode Implantation.

PubMed

Sahyouni, Ronald; Chang, David T; Moshtaghi, Omid; Mahmoodi, Amin; Djalilian, Hamid R; Lin, Harrison W

2017-04-01

Permanent injury to the cranial nerves can often result in a substantial reduction in quality of life. Novel and innovative interventions can help restore form and function in nerve paralysis, with bioelectric interfaces among the more promising of these approaches. The foreign body response is an important consideration for any bioelectric device as it influences the function and effectiveness of the implant. The purpose of this review is to describe tissue and functional effects of chronic neural implantation among the different categories of neural implants and highlight advances in peripheral and cranial nerve stimulation. Data Sources : PubMed, IEEE, and Web of Science literature search. Review Methods : A review of the current literature was conducted to examine functional and histologic effects of bioelectric interfaces for neural implants. Bioelectric devices can be characterized as intraneural, epineural, perineural, intranuclear, or cortical depending on their placement relative to nerves and neuronal cell bodies. Such devices include nerve-specific stimulators, neuroprosthetics, brainstem implants, and deep brain stimulators. Regardless of electrode location and interface type, acute and chronic histological, macroscopic and functional changes can occur as a result of both passive and active tissue responses to the bioelectric implant. A variety of chronically implantable electrodes have been developed to treat disorders of the peripheral and cranial nerves, to varying degrees of efficacy. Consideration and mitigation of detrimental effects at the neural interface with further optimization of functional nerve stimulation will facilitate the development of these technologies and translation to the clinic. 3.

Biocorrosion of magnesium alloys: a new principle in cardiovascular implant technology?

PubMed Central

Heublein, B; Rohde, R; Kaese, V; Niemeyer, M; Hartung, W; Haverich, A

2003-01-01

Objectives: To develop and test a new concept of the degradation kinetics of newly developed coronary stents consisting of magnesium alloys. Methods: Design of a coronary stent prototype consisting of the non-commercial magnesium based alloy AE21 (containing 2% aluminium and 1% rare earths) with an expected 50% loss of mass within six months. Eleven domestic pigs underwent coronary implantation of 20 stents (overstretch injury). Results: No stent caused major problems during implantation or showed signs of initial breakage in the histological evaluation. There were no thromboembolic events. Quantitative angiography at follow up showed a significant (p < 0.01) 40% loss of perfused lumen diameter between days 10 and 35, corresponding to neointima formation seen on histological analysis, and a 25% re-enlargement (p < 0.05) between days 35 and 56 caused by vascular remodelling (based on intravascular ultrasound) resulting from the loss of mechanical integrity of the stent. Inflammation (p < 0.001) and neointimal plaque area (p < 0.05) depended significantly on injury score. Planimetric degradation correlated with time (r = 0.67, p < 0.01). Conclusion: Vascular implants consisting of magnesium alloy degradable by biocorrosion seem to be a realistic alternative to permanent implants. PMID:12748224

Biocorrosion of magnesium alloys: a new principle in cardiovascular implant technology?

PubMed

Heublein, B; Rohde, R; Kaese, V; Niemeyer, M; Hartung, W; Haverich, A

2003-06-01

To develop and test a new concept of the degradation kinetics of newly developed coronary stents consisting of magnesium alloys. Design of a coronary stent prototype consisting of the non-commercial magnesium based alloy AE21 (containing 2% aluminium and 1% rare earths) with an expected 50% loss of mass within six months. Eleven domestic pigs underwent coronary implantation of 20 stents (overstretch injury). No stent caused major problems during implantation or showed signs of initial breakage in the histological evaluation. There were no thromboembolic events. Quantitative angiography at follow up showed a significant (p < 0.01) 40% loss of perfused lumen diameter between days 10 and 35, corresponding to neointima formation seen on histological analysis, and a 25% re-enlargement (p < 0.05) between days 35 and 56 caused by vascular remodelling (based on intravascular ultrasound) resulting from the loss of mechanical integrity of the stent. Inflammation (p < 0.001) and neointimal plaque area (p < 0.05) depended significantly on injury score. Planimetric degradation correlated with time (r = 0.67, p < 0.01). Vascular implants consisting of magnesium alloy degradable by biocorrosion seem to be a realistic alternative to permanent implants.

Echocardiography in patients with complications related to pacemakers and cardiac defibrillators.

PubMed

Almomani, Ahmed; Siddiqui, Khadija; Ahmad, Masood

2014-03-01

The evolving indications and uses for implantable cardiac devices have led to a significant increase in the number of implanted devices each year. Implantation of endocardial leads for permanent pacemakers and cardiac defibrillators can cause many delayed complications. Complications may be mechanical and related to the interaction of the device leads with the valves and endomyocardium, e.g., perforation, infection, and thrombosis, or due to the electrical pacing of the myocardium and conduction abnormalities, e.g., left ventricular dyssynchrony. Tricuspid regurgitation, another delayed complication in these patients, may be secondary to both mechanical and pacing effects of the device leads. Echocardiography plays an important role in the diagnosis of these device-related complications. Both two-dimensional transthoracic echocardiography and transesophageal echocardiography provide useful diagnostic information. Real time three-dimensional echocardiography is a novel technique that can further enhance the detection of lead-related complications. © 2013, Wiley Periodicals, Inc.

Stress influenced trapping processes in Si based multi-quantum well structures and heavy ions implanted Si

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

Ciurea, Magdalena Lidia, E-mail: ciurea@infim.ro; Lazanu, Sorina, E-mail: ciurea@infim.ro

2014-10-06

Multi-quantum well structures and Si wafers implanted with heavy iodine and bismuth ions are studied in order to evaluate the influence of stress on the parameters of trapping centers. The experimental method of thermostimullatedcurrents without applied bias is used, and the trapping centers are filled by illumination. By modeling the discharge curves, we found in multilayered structures the parameters of both 'normal' traps and 'stress-induced' ones, the last having a Gaussian-shaped temperature dependence of the cross section. The stress field due to the presence of stopped heavy ions implanted into Si was modeled by a permanent electric field. The increasemore » of the strain from the neighborhood of I ions to the neighborhood of Bi ions produces the broadening of some energy levels and also a temperature dependence of the cross sections for all levels.« less

Stress influenced trapping processes in Si based multi-quantum well structures and heavy ions implanted Si

NASA Astrophysics Data System (ADS)

Ciurea, Magdalena Lidia; Lazanu, Sorina

2014-10-01

Multi-quantum well structures and Si wafers implanted with heavy iodine and bismuth ions are studied in order to evaluate the influence of stress on the parameters of trapping centers. The experimental method of thermostimullatedcurrents without applied bias is used, and the trapping centers are filled by illumination. By modeling the discharge curves, we found in multilayered structures the parameters of both 'normal' traps and 'stress-induced' ones, the last having a Gaussian-shaped temperature dependence of the cross section. The stress field due to the presence of stopped heavy ions implanted into Si was modeled by a permanent electric field. The increase of the strain from the neighborhood of I ions to the neighborhood of Bi ions produces the broadening of some energy levels and also a temperature dependence of the cross sections for all levels.

Orthodontic extrusion of the lower third molar with an orthodontic mini implant.

PubMed

Park, Wonse; Park, Joon-Soo; Kim, Yun-Mi; Yu, Hyung-Seog; Kim, Kee-Deog

2010-10-01

Neurologic changes owing to damage to the inferior alveolar nerve (IAN) are the most serious complication of lower third molar (M3) extraction because of their close spatial relationship. We adopted the concept of regional orthodontic treatment and extrusion, using skeletal anchorage with an orthodontic mini implant. Two malformed M3s that were closely apposed to the IAN were extruded with the aid of 3 or 4 orthodontic brackets and a mini implant. Both of the M3s were extruded successfully. The patients experienced little discomfort with the orthodontic appliances and there was neither permanent neurologic damage nor fracture of the root fragments following subsequent M3 extraction. Orthodontic treatment using a miniscrew to separate the IAN and M3, or luxation of the M3 may be a good alternative treatment option for extrusion of a vertically impacted lower M3 with fragile roots. Copyright © 2010 Mosby, Inc. All rights reserved.

Injectable fillers: review of material and properties.

PubMed

Attenello, Natalie Huang; Maas, Corey S

2015-02-01

With an increasing understanding of the aging process and the rapidly growing interest in minimally invasive treatments, injectable facial fillers have changed the perspective for the treatment and rejuvenation of the aging face. Other than autologous fat and certain preformed implants, the collagen family products were the only Food and Drug Administration approved soft tissue fillers. But the overwhelming interest in soft tissue fillers had led to the increase in research and development of other products including bioengineered nonpermanent implants and permanent alloplastic implants. As multiple injectable soft tissue fillers and biostimulators are continuously becoming available, it is important to understand the biophysical properties inherent in each, as these constitute the clinical characteristics of the product. This article will review the materials and properties of the currently available soft tissue fillers: hyaluronic acid, calcium hydroxylapatite, poly-l-lactic acid, polymethylmethacrylate, and autologous fat (and aspirated tissue including stem cells). Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

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.

Synchrotron Radiation Research--An Overview.

ERIC Educational Resources Information Center

Bienenstock, Arthur; Winick, Herman

1983-01-01

Discusses expanding user community seeking access to synchrotron radiation sources, properties/sources of synchrotron radiation, permanent-magnet technology and its impact on synchrotron radiation research, factors limiting power, the density of synchrotron radiation, and research results illustrating benefit of higher flux and brightness. Also…

Buildings That Teach.

ERIC Educational Resources Information Center

Wiebenson, John

1998-01-01

Teachers can use "built teaching aids" or elements of the school building itself to expand teaching and enhance learning. Possibilities include bulletin boards, display cases, murals painted by local artists, permanent information panels, interior windows to classrooms, flags, and bas-reliefs on building exteriors. Playground pavement…

Expandable stents.

PubMed

Nesbitt, J C; Carrasco, H

1996-05-01

Expandable metallic stents are effective in selected patients with malignant or benign airway stenoses. When used for malignant lesions, the primary purpose of the stent is to improve the quality of life; stents are usually chosen for palliation of symptoms in recognition of the low likelihood of success for other therapy. For patients with benign stenoses, the stents provide a permanent source of structural support to alleviate the narrowed segment. The advantages of the expandable metallic stents are as follows: (1) they can be inserted through an endotracheal tube or under local anesthesia with relative simplicity under fluoroscopic guidance; (2) they do not impair the drainage of sputum because ciliary movement is not interrupted; (3) over a period of a few weeks, the meshwork is gradually covered with mucosa as the stent becomes incorporated into the airway wall; (4) ventilation usually is not impaired if the metallic mesh stent covers another nonstenosed bronchus, because the interstices of the stent are nonobstructive; and (5) they are dynamic and continue to expand over time, particularly if concurrent treatment achieves an effect on the lesion that caused stenosis. Disadvantages of the expandable stent include (1) they often are only temporarily effective for tracheobronchial stenosis due to intraluminal tumor or granulation tissue, both of which can grow between the wires; (2) they are considered permanent stents because removal is difficult; and (3) they can be poorly positioned during placement or can become displaced by progressive migration after placement, and they cannot be repositioned. A relative contraindication to insertion is an inflammatory process or infection that can predispose to granulation formation, particularly at the points of maximal contact pressure of the stent to the airway mucosa. In the presence of inflammation, it may be better to use a silicone prosthesis until the inflammatory process subsides and fibrosis occurs. Granulation tissue is less likely to occur in areas of established scar than in areas of acute inflammation. In circumstances in which it is essential that a stent remain only temporarily, an expandable stent should not be inserted in favor of a silicone stent, which can be removed. In the future, expandable stents may have silicone coverings or may be constructed of materials that facilitate removal. Until that time, expandable stents should be considered permanent and nonremovable. Subtle differences exist among the available stents. Standard is low-profile expandable construction from wire mesh. A relatively minor difference is the slightly wider expansibility of the Gianturco stent, a quality that makes it the best suited of the three stents for lesions that involve tracheomalacia. Perhaps the only major difference between the Wallstent and the Gianturco and Palmaz stents is its better ability to conform to tortuous lesions. In an acutely angled stricture, a Wallstent offers a better opportunity for successful placement than other stents. The filamentous meshwork of the Wallstent allows it to bend and conform better to distorted airways. The Gianturco and Palmaz stents have little longitudinal elasticity, which makes them less effective in a tortuous or highly angulated airway stenosis. Expandable stents have demonstrated their efficacy and exposed their limitations in the treatment of airway stenoses. Refinements in design should help to lessen specific disadvantages and problems. Covered expandable stents, a realistic prospect, have specific advantages over standard expandable stents; they will be removable and prevent tumor ingrowth. Current investigative work with such prostheses for the vascular system may provide the foundation for their investigative use in the airway. In essence, two categories of expandable stents are evolving, covered and uncovered, each having unique features adaptable to the specific clinical needs.

Management of Mastectomy Skin Necrosis in Implant Based Breast Reconstruction.

PubMed

Sue, Gloria R; Long, Chao; Lee, Gordon K

2017-05-01

Mastectomy skin necrosis is a significant problem after breast reconstruction. This complication may lead to poor wound healing and need for implant removal, which may delay subsequent oncologic treatment. We sought to characterize factors associated with mastectomy skin necrosis and propose a management algorithm. A retrospective review was performed on consecutive patients undergoing implant-based breast reconstruction by the senior author from 2006 through 2015. Patient-level factors including age, race, body mass index, history of hypertension, history of diabetes, history of smoking, and history of radiation were collected. Surgical factors including type of mastectomy, location of implant placement, and immediate versus delayed reconstruction were collected. The incidence and treatment of mastectomy skin necrosis were analyzed. A total of 293 patients underwent either unilateral or bilateral implant-based breast reconstructions after mastectomy with a total of 471 reconstructed breasts. Mastectomy skin necrosis was observed in 8.1% of reconstructed breasts. Skin necrosis was not associated with age, hypertension, diabetes, prior radiation, or type of mastectomy. The incidence of skin necrosis was higher among smokers (17.9% vs 5.0%, P < 0.001), among patients with higher body mass index (11.4% vs 6.1%, P = 0.05), patients who underwent immediate reconstruction compared to delayed (9.6% vs 0%, P = 0.004), placement of expander under acellular dermal matrix compared with submuscular placement (12.0% vs 5.2%, P = 0.02), and use of higher initial expander fill volume compared with lower fill volume (11.4% vs 5.4%, P = 0.02).The median necrosis size was 8 cm. The median time to treatment was 15 days postoperatively. In 55% of patients minor necrosis was treated with clinic debridement, whereas 43% had larger areas of necrosis requiring operative debridement. The median size treated with clinic debridement was 5.5 cm, compared to 15 cm for operative debridement. All necrosis was treated in a timely fashion and did not delay adjuvant therapy. Mastectomy skin necrosis occurred in 8.1% of breasts after implant-based reconstruction. Necrosis less than 10 cm can be treated successfully with local debridement in the clinic setting. Timely and appropriate treatment of skin necrosis with debridement and primary closure expedites wound healing and facilitates tissue expander breast reconstruction.

AUDITORY NUCLEI: DISTINCTIVE RESPONSE PATTERNS TO WHITE NOISE AND TONES IN UNANESTHETIZED CATS.

PubMed

GALIN, D

1964-10-09

Electrical responses to "white" noise and tonal stimuli were recorded from unanesthetized cats with permanently implanted bipolar electrodes. The cochlear nucleus, inferior colliculus, and medial geniculate each showed distinctive patterns of evoked activity. White noise and tones produced qualitatively different types of response. A decrease in activity characterized the response of the inferior colliculus to tonal stimuli.

Paroxysmal atrioventricular block: Electrophysiological mechanism of phase 4 conduction block in the His-Purkinje system: A comparison with phase 3 block.

PubMed

Shenasa, Mohammad; Josephson, Mark E; Wit, Andrew L

2017-11-01

Paroxysmal atrioventricular (A-V) block is relatively rare, and due to its transient nature, it is often under recognized. It is often triggered by atrial, junctional, or ventricular premature beats, and occurs in the presence of a diseased His-Purkinje system (HPS). Here, we present a 45-year-old white male who was admitted for observation due to recurrent syncope and near-syncope, who had paroxysmal A-V block. The likely cellular electrophysiological mechanisms(s) of paroxysmal A-V block and its differential diagnosis and management are discussed. Continuous electrocardiographic monitoring was done while the patient was in the cardiac unit. Multiple episodes of paroxysmal A-V block were documented in this case. All episodes were initiated and terminated with atrial/junctional premature beats. The patient underwent permanent pacemaker implantation and has remained asymptomatic since then. Paroxysmal A-V block is rare and often causes syncope or near-syncope. Permanent pacemaker implantation is indicated according to the current guidelines. Paroxysmal A-V block occurs in the setting of diseased HPS and is bradycardia-dependent. The detailed electrophysiological mechanisms, which involve phase 4 diastolic depolarization, and differential diagnosis are discussed. © 2017 Wiley Periodicals, Inc.

Sacral neuromodulation for women with Fowler's syndrome.

PubMed

Swinn, M J; Kitchen, N D; Goodwin, R J; Fowler, C J

2000-10-01

Neuromodulation of the sacral nerves has been found to be an effective therapy for a variety of lower urinary tract dysfunctions. The reported success rate for the period of trial stimulation (peripheral nerve evaluation test) prior to permanent implantation of a sacral nerve stimulator is variable, but generally reported to be in the region of 30-50%. We present here the results of the peripheral nerve evaluation test in 38 patients with urinary retention. 34 of the 38 had been found to have an abnormality of their striated urethral sphincter on electromyography using a concentric needle electrode, i.e., they had the disorder which was described by Fowler and coworkers in 1988. The overall success rate in this group was 68%. We believe that our relatively high success rate is due to sacral neuromodulation working via a mechanism which involves the urethral sphincter, an abnormality which had been demonstrated in 89% of these patients. Twelve of the patients subsequently underwent permanent implantation of a sacral nerve stimulator, and all of them have experienced a return of voiding. However, in 2 patients, there is a persisting need for self-catheterization. There is, however, a high reoperation rate.

Hybrid Therapy in the Management of Atrial Fibrillation

PubMed Central

Stárek, Zdeněk; Lehar, František; Jež, Jiří; Wolf, Jiří; Novák, Miroslav

2015-01-01

Atrial fibrillation is the most common sustained arrhythmia. Because of the sub-optimal outcomes and associated risks of medical therapy as well as the recent advances in non-pharmacologic strategies, a multitude of combined (hybrid) algorithms have been introduced that improve efficacy of standalone therapies while maintaining a high safety profile. Antiarrhythmic administration enhances success rate of electrical cardioversion. Catheter ablation of antiarrhythmic drug-induced typical atrial flutter may prevent recurrent atrial fibrillation. Through simple ablation in the right atrium, suppression of atrial fibrillation may be achieved in patients with previously ineffective antiarrhythmic therapy. Efficacy of complex catheter ablation in the left atrium is improved with antiarrhythmic drugs. Catheter ablation followed by permanent pacemaker implantation is an effective and safe treatment option for selected patients. Additional strategies include pacing therapies such as atrial pacing with permanent pacemakers, preventive pacing algorithms, and/or implantable dual-chamber defibrillators are available. Modern hybrid strategies combining both epicardial and endocardial approaches in order to create a complex set of radiofrequency lesions in the left atrium have demonstrated a high rate of success and warrant further research. Hybrid therapy for atrial fibrillation reviews history of development of non-pharmacological treatment strategies and outlines avenues of ongoing research in this field. PMID:25028165

Prosthetically directed implant placement using computer software to ensure precise placement and predictable prosthetic outcomes. Part 2: rapid-prototype medical modeling and stereolithographic drilling guides requiring bone exposure.

PubMed

Rosenfeld, Alan L; Mandelaris, George A; Tardieu, Philippe B

2006-08-01

The purpose of this paper is to expand on part 1 of this series (published in the previous issue) regarding the emerging future of computer-guided implant dentistry. This article will introduce the concept of rapid-prototype medical modeling as well as describe the utilization and fabrication of computer-generated surgical drilling guides used during implant surgery. The placement of dental implants has traditionally been an intuitive process, whereby the surgeon relies on mental navigation to achieve optimal implant positioning. Through rapid-prototype medical modeling and the ste-reolithographic process, surgical drilling guides (eg, SurgiGuide) can be created. These guides are generated from a surgical implant plan created with a computer software system that incorporates all relevant prosthetic information from which the surgical plan is developed. The utilization of computer-generated planning and stereolithographically generated surgical drilling guides embraces the concept of collaborative accountability and supersedes traditional mental navigation on all levels of implant therapy.

Inferolateral migration of hydrogel orbital implants in microphthalmia.

PubMed

Tao, Jeremiah P; LeBoyer, Russell M; Hetzler, Kathy; Ng, John D; Nunery, William R

2010-01-01

Hydrogel spheres may be useful in treating orbital hypoplasia associated with congenital microphthalmia. The authors describe migration associated with the use of these devices. The authors retrospectively reviewed 5 cases in which a hydrogel orbital expander (Osmed) was implanted to treat orbital hypoplasia in pediatric patients with congenital microphthalmia (with or without previous surgery). In all 5 cases, a lateral orbitotomy, conjunctiva-sparing approach was used to insert the hydrogel spheres. Two cases involved previously unoperated orbits; 3 patients had prior orbit or socket surgery. Inferolateral movement outside the desired central, deep orbital position occurred in all 5 cases. Four of 5 cases required further procedures to achieve an adequate orbital implant position. Inferolateral migration may occur with hydrogel spheres implanted via a lateral orbitotomy approach in microphthalmia.

Evaluation of 39 medical implants at 7.0 T

PubMed Central

Feng, David X; McCauley, Joseph P; Morgan–Curtis, Fea K; Salam, Redoan A; Pennell, David R; Loveless, Mary E

2015-01-01

Objective: With increased signal to noise ratios, 7.0-T MRI has the potential to contribute unique information regarding anatomy and pathophysiology of a disease. However, concerns for the safety of subjects with metallic medical implants have hindered advancement in this field. The purpose of the present research was to evaluate the MRI safety for 39 commonly used medical implants at 7.0 T. Methods: Selected metallic implants were tested for magnetic field interactions, radiofrequency-induced heating and artefacts using standardized testing techniques. Results: 5 of the 39 implants tested may be unsafe for subjects undergoing MRI at 7.0 T. Conclusion: Implants were deemed either “MR Conditional” or “MR Unsafe” for the 7.0-T MRI environment. Further research is needed to expand the existing database categorizing implants that are acceptable for patients referred for MRI examinations at 7.0 T. Advances in knowledge: Lack of MRI testing for common metallic medical implants limits the translational potential of 7.0-T MRI. For safety reasons, patients with metallic implants are not allowed to undergo a 7.0-T MRI scan, precluding part of the population that can benefit from the detailed resolution of ultra-high-field MRIs. This investigation provides necessary MRI testing of common medical implants at 7.0 T. PMID:26481696

Three-dimensional (3D) printing and its applications for aortic diseases.

PubMed

Hangge, Patrick; Pershad, Yash; Witting, Avery A; Albadawi, Hassan; Oklu, Rahmi

2018-04-01

Three-dimensional (3D) printing is a process which generates prototypes from virtual objects in computer-aided design (CAD) software. Since 3D printing enables the creation of customized objects, it is a rapidly expanding field in an age of personalized medicine. We discuss the use of 3D printing in surgical planning, training, and creation of devices for the treatment of aortic diseases. 3D printing can provide operators with a hands-on model to interact with complex anatomy, enable prototyping of devices for implantation based upon anatomy, or even provide pre-procedural simulation. Potential exists to expand upon current uses of 3D printing to create personalized implantable devices such as grafts. Future studies should aim to demonstrate the impact of 3D printing on outcomes to make this technology more accessible to patients with complex aortic diseases.

[Percutaneously implantable aortic valve: the JenaValve concept evolution].

PubMed

Figulla, Hans R; Ferrari, Markus

2006-10-01

Due to the increasing incidence of severe aortic stenosis in old and multimorbid patients, the percutaneous implantation of aortic valve-carrying stents has become an alternative to the surgical replacement of aortic valves. Starting in 1995, the authors developed a self-expanding stent which transferred the necessary forces for anchoring up to the aorta ascendens-a conception taken over from CoreValve. The further improvement of this idea over the past 11 years has led to a self-expanding, relatively short stent-valve system that is reliably positioned in the cusps of the old aortic valve and holds the old valve like a paper clip, thus transferring the holding forces physiologically. As compared to conventional systems, the sophisticated insertion catheter requires further chronic animal tests so as to represent a true alternative to the conventional surgical procedure.

Immediate and early function of Brånemark System implants placed in the esthetic zone: a 1-year prospective clinical multicenter study.

PubMed

Maló, Paulo; Friberg, Bertil; Polizzi, Giovanni; Gualini, Federico; Vighagen, Torbjörn; Rangert, Bo

2003-01-01

Immediate/early implant function means great benefits for patients and therapists because treatment time and cost can be substantially reduced. This concept has become an accepted alternative for complete arch fixed restorations in the mandible, and clinical documentation is emerging for other indications. The purpose of this prospective clinical multicenter study was to evaluate the outcome of implants placed in incisor, canine, and premolar regions in maxillas or mandibles. Implants were loaded with provisional crowns and bridges on the same day or within a few days and were followed up for 1 year during function. Four centers treated 76 patients each in need of an implant-retained prosthesis in the anterior and premolar regions in the maxilla or mandible. A total of 116 titanium implants with machined surfaces (Brånemark System , Nobel Biocare AB, Gothenburg, Sweden) were placed: 74 in maxillas and 42 in mandibles. Eighty-seven prostheses were made, of which 63 were single crowns and 24 were bridges (supported by 53 splinted implants). Twenty-two implants in 14 patients were placed in fresh extraction sites. The goal with the preparation and insertion technique was to achieve good primary implant stability and a minimum implant insertion torque of 30 Ncm before the implant was completely seated. The occlusion was adjusted to eliminate direct contact with the provisional prostheses. After 6 months, the patients received their permanent prostheses. Sixty-seven patients were followed for 1 year. Five implants were lost in five patients, three in the maxilla and two in the mandible. Four of the lost implants were single-tooth replacements and one was splinted. The cumulative survival rate (CSR) was 95.7% for all implants after 1 year and 93.7% and 98.1% for single-tooth and splinted implants, respectively. There were no implant losses in the extraction sites. The CSR of 96% at 1 year indicates that immediate function of Brånemark System implants placed in incisor to premolar regions in both jaws is a viable concept. More failures occurred with single-tooth replacements (6.3%) than with splinted implants (1.9%).

Photovoltaic Retinal Prosthesis for Restoring Sight to Patients Blinded by Retinal Injury or Degeneration

DTIC Science & Technology

2016-02-01

are rapidly expanding [1][2]. Cochlear implants [3] have seen the most remarkable success in sensory neuroprosthetics, while retinal implants [4][5...intensities: Imax (bright pixels) and Imin (dark pixels). In the common return configurations (connected and monopolar), the current flowing through the...array forces the injected current to flow to the back side, which results in a potential build-up in front of the device. Near each pixel (within

Concomitant contraceptive implant and efavirenz use in women living with HIV: perspectives on current evidence and policy implications for family planning and HIV treatment guidelines

PubMed Central

Patel, Rena C.; Morroni, Chelsea; Scarsi, Kimberly K.; Sripipatana, Tabitha; Kiarie, James; Cohen, Craig R.

2017-01-01

Abstract Introduction: Preventing unintended pregnancies is important among all women, including those living with HIV. Increasing numbers of women, including HIV-positive women, choose progestin-containing subdermal implants, which are one of the most effective forms of contraception. However, drug–drug interactions between contraceptive hormones and efavirenz-based antiretroviral therapy (ART) may reduce implant effectiveness. We present four inter-related perspectives on this issue. Discussion: First, as a case study, we discuss how limited data prompted country-level guidance against the use of implants among women concomitantly using efavirenz in South Africa and its subsequent negative effects on the use of implants in general. Second, we discuss the existing clinical data on this topic, including the observational study from Kenya showing women using implants plus efavirenz-based ART had three-fold higher rates of pregnancy than women using implants plus nevirapine-based ART. However, the higher rates of pregnancy in the implant plus efavirenz group were still lower than the pregnancy rates among women using common alternative contraceptive methods, such as injectables. Third, we discuss the four pharmacokinetic studies that show 50–70% reductions in plasma progestin concentrations in women concurrently using efavirenz-based ART as compared to women not on any ART. These pharmacokinetic studies provide the biologic basis for the clinical findings. Fourth, we discuss how data on this topic have marked implications for both family planning and HIV programmes and policies globally. Conclusion: This controversy underlines the importance of integrating family planning services into routine HIV care, counselling women appropriately on increased risk of pregnancy with concomitant implant and efavirenz use, and expanding contraceptive method mix for all women. As global access to ART expands, greater research is needed to explore implant effectiveness when used concomitantly with newer ART regimens. Data on how HIV-positive women and their partners choose contraceptives, as well as information from providers on how they present and counsel patients on contraceptive options are needed to help guide policy and service delivery. Lastly, greater collaboration between HIV and reproductive health experts at all levels are needed to develop successful strategies to ensure the best HIV and reproductive health outcomes for women living with HIV. PMID:28530033

Concomitant contraceptive implant and efavirenz use in women living with HIV: perspectives on current evidence and policy implications for family planning and HIV treatment guidelines.

PubMed

Patel, Rena C; Morroni, Chelsea; Scarsi, Kimberly K; Sripipatana, Tabitha; Kiarie, James; Cohen, Craig R

2017-05-11

Preventing unintended pregnancies is important among all women, including those living with HIV. Increasing numbers of women, including HIV-positive women, choose progestin-containing subdermal implants, which are one of the most effective forms of contraception. However, drug-drug interactions between contraceptive hormones and efavirenz-based antiretroviral therapy (ART) may reduce implant effectiveness. We present four inter-related perspectives on this issue. First, as a case study, we discuss how limited data prompted country-level guidance against the use of implants among women concomitantly using efavirenz in South Africa and its subsequent negative effects on the use of implants in general. Second, we discuss the existing clinical data on this topic, including the observational study from Kenya showing women using implants plus efavirenz-based ART had three-fold higher rates of pregnancy than women using implants plus nevirapine-based ART. However, the higher rates of pregnancy in the implant plus efavirenz group were still lower than the pregnancy rates among women using common alternative contraceptive methods, such as injectables. Third, we discuss the four pharmacokinetic studies that show 50-70% reductions in plasma progestin concentrations in women concurrently using efavirenz-based ART as compared to women not on any ART. These pharmacokinetic studies provide the biologic basis for the clinical findings. Fourth, we discuss how data on this topic have marked implications for both family planning and HIV programmes and policies globally. This controversy underlines the importance of integrating family planning services into routine HIV care, counselling women appropriately on increased risk of pregnancy with concomitant implant and efavirenz use, and expanding contraceptive method mix for all women. As global access to ART expands, greater research is needed to explore implant effectiveness when used concomitantly with newer ART regimens. Data on how HIV-positive women and their partners choose contraceptives, as well as information from providers on how they present and counsel patients on contraceptive options are needed to help guide policy and service delivery. Lastly, greater collaboration between HIV and reproductive health experts at all levels are needed to develop successful strategies to ensure the best HIV and reproductive health outcomes for women living with HIV.

Five-year Experience with Perma Facial Implant

PubMed Central

Raphael, Peter; Harris, Ryan

2014-01-01

Summary: Augmentation cheiloplasty is becoming an increasingly popular aesthetic procedure despite current methodologies having met with disappointment among surgeons and patients. The goal of this study was to examine the benefits and drawbacks of 1 device in particular—Perma Facial Implant (PFI). The senior authors (P.R. and S.W.H.) performed 832 consecutive PFI lip augmentations with excellent results based on photographic documentation, patient satisfaction surveys, unbiased surgeon ratings, and low complication rates. In addition to augmenting thin lips, PFIs hide excess dentition and improve vermilion rhytids and pout. Contrary to alternatives, they are both permanent and reversible. However, they do not level out asymmetries or benefit razor-thin lips without prior lifting or mucosal advancement. PMID:25289346

[Nano-hydroxyapatite/collagen composite for bone repair].

PubMed

Feng, Qing-ling; Cui, Fu-zhai; Zhang, Wei

2002-04-01

To develop nano-hydroxyapatite/collagen (NHAC) composite and test its ability in bone repairing. NHAC composite was developed by biomimetic method. The composite showed some features of natural bone in both composition and microstructure. The minerals could contribute to 50% by weight of the composites in sheet form. The inorganic phase in the composite was carbonate-substituted hydroxyapatite (HA) with low crystallinity and nanometer size. HA precipitates were uniformly distributed on the type I collagen matrix without preferential orientation. The composite exhibited an isotropic mechanical behavior. However, the resistance of the composite to localized pressure could reach the lower limit of that of femur compacta. The tissue response to the NHAC composite implanted in marrow cavity was investigated. Knoop micro-hardness test was performed to compare the mechanical behavior of the composite and bone. At the interface of the implant and marrow tissue, solution-mediated dissolution and macrophage-mediated resorption led to the degradation of the composite, followed by interfacial bone formation by osteoblasts. The process of implant degradation and bone substitution was reminiscent of bone remodeling. The composite can be incorporated into bone metabolism instead of being a permanent implant.

[New concepts for pressure-controlled glaucoma implants].

PubMed

Allemann, R; Stachs, O; Falke, K; Schmidt, W; Siewert, S; Sternberg, K; Chichkov, B; Wree, A; Schmitz, K-P; Guthoff, R F

2013-08-01

In industrialized countries glaucoma is one of the most common causes that leads to blindness. It is also the most common cause of irreversible blindness worldwide. In addition to local treatment of intraocular pressure and filtering glaucoma surgery, alloplastic implants are increasingly being used in glaucoma therapy. As long-term results published in the literature of commonly used implants are unsatisfactory, it seems useful to search for new concepts. In order to avoid the well-known short-term and long-term postoperative complications a pressure-controlled microstent with antiproliferative surface modifications was developed. Additionally, the functionality of such a microstent should be investigated using an animal glaucoma model. This paper describes the concept of a microstent which drains aquous humour from the anterior chamber into the suprachoroidal space. In addition, the glaucoma models described in the literature are discussed. Unfortunately, none of the methods could be reproduced permanently. First results show a correct implantation of a coated microstent with valve where the anti-proliferative effect could be demonstrated histologically. The promising results should lead to further investigations and the final goal will be the testing of the stent in the human eye.

Absorbable magnesium-based stent: physiological factors to consider for in vitro degradation assessments

PubMed Central

Wang, Juan; Smith, Christopher E.; Sankar, Jagannathan; Yun, Yeoheung; Huang, Nan

2015-01-01

Absorbable metals have been widely tested in various in vitro settings using cells to evaluate their possible suitability as an implant material. However, there exists a gap between in vivo and in vitro test results for absorbable materials. A lot of traditional in vitro assessments for permanent materials are no longer applicable to absorbable metallic implants. A key step is to identify and test the relevant microenvironment and parameters in test systems, which should be adapted according to the specific application. New test methods are necessary to reduce the difference between in vivo and in vitro test results and provide more accurate information to better understand absorbable metallic implants. In this investigative review, we strive to summarize the latest test methods for characterizing absorbable magnesium-based stent for bioabsorption/biodegradation behavior in the mimicking vascular environments. Also, this article comprehensively discusses the direction of test standardization for absorbable stents to paint a more accurate picture of the in vivo condition around implants to determine the most important parameters and their dynamic interactions. PMID:26816631

Efficacy of postoperative prophylactic antibiotics in reducing permanent pacemaker infections.

PubMed

Lee, Wen-Huang; Huang, Ting-Chun; Lin, Li-Jen; Lee, Po-Tseng; Lin, Chih-Chan; Lee, Cheng-Han; Chao, Ting-Hsing; Li, Yi-Heng; Chen, Ju-Yi

2017-08-01

Despite limited evidence, postoperative prophylactic antibiotics are often used in the setting of permanent pacemaker implantation or replacement. The aim of this study is to investigate the efficacy of postoperative antibiotics. Postoperative prophylactic antibiotics may be not clinically useful. We recruited 367 consecutive patients undergoing permanent pacemaker implantation or generator replacement at a tertiary referral center. Baseline demographics, clinical characteristics, and procedure information were collected, and all patients received preoperative prophylactic antibiotics. Postoperative prophylactic antibiotics were administered at the discretion of the treating physician, and all patients were seen in follow-up every 3 to 6 months for an average follow-up period of 16 months. The primary endpoint was device-related infection. A total of 110 patients were treated with preoperative antibiotics only (group 1), whereas 257 patients received both preoperative and postoperative antibiotics (group 2). After a mean follow-up period of 16 months, 1 patient in group 1 (0.9%) and 4 patients in group 2 (1.5%) experienced a device-related infection. There was no significant difference in the rate of infection between the 2 groups (P = 0.624). In the univariate analysis, only the age (60 ± 11 vs 75 ± 12 years, P < 0.001) was significantly different between the infected and noninfected groups. In the multivariate analysis, younger age was an independent risk factor for infective complications (odds ratio = 1.08, P = 0.016). Patients treated with preoperative and postoperative antibiotics had a similar rate of infection as those treated with preoperative antibiotics alone. Further studies are needed to confirm these preliminary findings. © 2017 Wiley Periodicals, Inc.

Defining the rectal dose constraint for permanent radioactive seed implantation of the prostate.

PubMed

Albert, Michele; Song, Jun S; Schultz, Delray; Cormack, Robert A; Tempany, Clare M; Haker, Steve; Devlin, Phillip M; Beard, Clair; Hurwitz, Mark D; Suh, Wonsuk W; Jolesz, Ferenc; D'Amico, Anthony V

2008-01-01

This study was performed to define the rectal dose constraint that would predict late rectal bleeding requiring argon plasma coagulation (APC) following prostate brachy mono-therapy. Between February 1999 and April 2002, 91 patients with low risk prostate cancer underwent permanent I(125) radioactive seed implantation without the use of supplemental external beam radiation or androgen suppression therapy. Patients received both CT and MRI scans 6 weeks postimplant for evaluation of dosimetry. The CT and MRI scans were fused. Rectal volumes were contoured on the T2 weighted MR images. For those patients requiring APC, the date on which a patient reported rectal bleeding was recorded. A Cox regression analysis was performed to assess whether there was a significant association between the rectal volume (continuous) exceeding 100 Gy time rectal bleeding. Comparisons of estimates of rectal bleeding requiring APC were made using a 2-sided log rank test. There was a significant association (hazard ratio = 5.6 [95% confidence interval: 1.3, 23.8]; P = 0.002) between the rectal volume exceeding 100 Gy and rectal bleeding requiring APC. After a median follow-up of 4.25 (1-6) years, no patient with less than a median value of 8 cc of rectum exceeding 100 Gy required APC, whereas 20% (P = 0.004) were estimated to require APC within 3 years following treatment. Keeping the rectal volume receiving more than 100 Gy below 8 cc will minimize the risk of rectal bleeding requiring APC following I(125) permanent prostate brachy mono-therapy.

CrN precipitation and elemental segregation during the decay of expanded austenite

NASA Astrophysics Data System (ADS)

Manova, D.; Lotnyk, A.; Mändl, S.; Neumann, H.; Rauschenbach, B.

2016-06-01

Nitrogen insertion into austenitic stainless steel at elevated temperatures leads to anomalous fast nitrogen diffusion and the formation of an expanded fcc phase which is known as expanded austenite. In situ x-ray diffraction measurements during low energy nitrogen ion implantation into steel AISI 304 at 475 °C and short annealing at 575 °C were performed in conjunction with transmission electron microscopy investigations. They show the time dependent decay of this expanded phase with coalescing and growing CrN precipitates. There is elemental segregation associated with this decay where Fe is absent very early from the Cr-N containing precipitates. Ni is segregating towards the Fe-rich matrix more slowly. At the same time, the microstructure—decayed phase vs expanded austenite—is visible in SIMS cluster analysis.

New Cogging Torque Reduction Methods for Permanent Magnet Machine

NASA Astrophysics Data System (ADS)

Bahrim, F. S.; Sulaiman, E.; Kumar, R.; Jusoh, L. I.

2017-08-01

Permanent magnet type motors (PMs) especially permanent magnet synchronous motor (PMSM) are expanding its limbs in industrial application system and widely used in various applications. The key features of this machine include high power and torque density, extending speed range, high efficiency, better dynamic performance and good flux-weakening capability. Nevertheless, high in cogging torque, which may cause noise and vibration, is one of the threat of the machine performance. Therefore, with the aid of 3-D finite element analysis (FEA) and simulation using JMAG Designer, this paper proposed new method for cogging torque reduction. Based on the simulation, methods of combining the skewing with radial pole pairing method and skewing with axial pole pairing method reduces the cogging torque effect up to 71.86% and 65.69% simultaneously.

Indications for permanent pacing and pacing mode prescription from 1989 to 2006. Experience of a single academic centre in Northern Greece.

PubMed

Styliadis, Ioannis H; Mantziari, Aggeliki P; Gouzoumas, Nikolaos I; Vassilikos, Vasilios P; Paraskevaidis, Stelios A; Mochlas, Sotirios T; Boufidou, Amalia I; Parcharidis, Georgios E

2008-01-01

Indications for pacing and pacing mode prescription have changed in the past decades following advances in pacemaker technology. The aim of the present study was to evaluate changes in indications for pacing and pacing modes during the years 1989-2006 in a single academic pacemaker centre in Northern Greece. Archives of permanent pacemaker implantation procedures were studied retrospectively and data from all implants, first or replacements, were retrieved. Data from 2078 procedures were found, 78.7% of which were first implantations. Patients were 54% male with mean age 72.5 years. Main indications for pacing were atrioventricular block (AVB, 45.7%), sick sinus syndrome (SSS, 32.8%), and atrial fibrillation (12.1%). Almost half (48.9%) of the AVB cases were complete AVB, while the most common types of SSS were tachy-brady syndrome (44.1%) and asystole (27.1%). Rare indications for pacing were carotid sinus syndrome (5.0%), heart failure (3.3%) and hypertrophic obstructive cardiomyopathy (1.0%). The two most frequently used pacing modes were VVI (38.5%) and DDD (25.8%). However, pacing modes have changed greatly over the years, with a marked increase in dual-chamber pacing after 1997 and a preference for rate responsive units after 2002. Biventricular systems were also used in selected patients with heart failure from 2002 on. Indications for pacing and pacing mode prescription in our centre are similar to other pacemaker registries and reflect the global trend in pacing for mimicking the physiological activity of the heart and for addressing problems other than symptomatic bradycardia.

Relationship between temperature change and the requirement for a permanent pacemaker implantation in bradyarrhythmias.

PubMed

Liu, I-Fan; Chang, Shih-Lin; Lo, Li-Wei; Hu, Yu-Feng; Tuan, Ta-Chuan; Kong, Chi-Woon; Wu, Tsu-Juey; Chiang, Chern-En; Chen, Shih-Ann; Lin, Yenn-Jiang

2011-09-01

Some cardiovascular diseases are associated with seasonal or meteorological factors. We tried to identify the relationship between meteorological parameters and the requirement for a permanent pacemaker (PPM) implantation for advanced sinus node dysfunction (SND) and atrioventricular block (AVB). This study enrolled 656 patients (67% male, age = 76 ± 11 years) who underwent a PPM implantation due to SND or AVB from January 2004 to December 2008. Using daily temperature, barometric pressure, humidity, and daylight hour records from Taipei, we evaluated the effect of these meteorological parameters within different time periods on the occurrence of SND and AVB. There were 355 patients in the SND group and 301 in the AVB group. In the AVB group, more patients presented in the spring than in other seasons (P = 0.003). In the SND group, there was no relationship with the seasons (P = 0.137). The proportion of patients with AVB did not depend on the average temperature, barometric pressure, humidity, or daylight hours within 3, 7, and 14 days prior to admission (P = NS). A temperature change of greater than 11°C within 30 days prior to admission was associated with a significantly higher proportion of patients with advanced AVB compared to those with advanced SND (P = 0.009). Extreme change in temperature was the most independent predictor of the development of advanced AVB. The peak occurrence of advanced AVB was in the spring. The occurrence of advanced AVB was associated with extreme temperature changes within 30 days, especially in the spring.

Towards retrievable vascularized bioartificial pancreas: induction and long-lasting stability of polymeric mesh implant vascularized with the help of acidic and basic fibroblast growth factors and hydrogel coating.

PubMed

Prokop, A; Kozlov, E; Nun Non, S; Dikov, M M; Sephel, G C; Whitsitt, J S; Davidson, J M

2001-01-01

We seek to improve existing methodologies for allogenic grafting of pancreatic islets. The lack of success of encapsulated transplanted islets inside the peritoneal cavity is presently attributed to poor vascularization of the implant. A thick, fibrotic capsule often surrounds the graft, limiting survival. We have tested the hypothesis that neovascularization of the graft material can be induced by the addition of proper angiogenic factors embedded within a polymeric coat. Biocompatible and nonresorbable meshes coated with hydrophilic polymers were implanted in rats and harvested after 1-, 6-, and 12-week intervals. The implant response was assessed by histological observations on the degree of vascularity, fibrosis, and inflammation. Macrostructural geometry of meshes was conducive to tissue ingrowth into the interstitial space between the mesh filaments. Hydrogel coating with incorporated acidic or basic FGF in an electrostatic complex with polyelectrolytes and/or with heparin provided a sustained slow release of the angiogenic growth factor. Anti-factor VIII and anti-collagen type IV antibodies and a GSL I-B4 lectin were used to measure the extent of vascularization. Vigorous and persistent vascularization radiated several hundred microns from the implant. The level of vascularization should provide a sufficient diffusion of nutrients and oxygen to implanted islets. Based on our observations, stable vascularization may require a sustained angiogenic signal to allow for the development of a permanent implant structure.

Mechanical properties of nitrogen-rich surface layers on SS304 treated by plasma immersion ion implantation

NASA Astrophysics Data System (ADS)

Fernandes, B. B.; Mändl, S.; Oliveira, R. M.; Ueda, M.

2014-08-01

The formation of hard and wear resistant surface regions for austenitic stainless steel through different nitriding and nitrogen implantation processes at intermediate temperatures is an established technology. As the inserted nitrogen remains in solid solution, an expanded austenite phase is formed, accounting for these surface improvements. However, experiments on long-term behavior and exact wear processes within the expanded austenite layer are still missing. Here, the modified layers were produced using plasma immersion ion implantation with nitrogen gas and had a thickness of up to 4 μm, depending on the processing temperature. Thicker layers or those with higher surface nitrogen contents presented better wear resistance, according to detailed microscopic investigation on abrasion, plastic deformation, cracking and redeposition of material inside the wear tracks. At the same time, cyclic fatigue testing employing a nanoindenter equipped with a diamond ball was carried out at different absolute loads and relative unloadings. As the stress distribution between the modified layer and the substrate changes with increasing load, additional simulations were performed for obtaining these complex stress distributions. While high nitrogen concentration and/or thicker layers improve the wear resistance and hardness, these modifications simultaneously reduce the surface fatigue resistance.

Indications and Controversies for Complete and Implant-Enhanced Latissimus Dorsi Breast Reconstructions.

PubMed

Mushin, Oren P; Myers, Paige L; Langstein, Howard N

2018-01-01

This article describes the use of implant-enhanced and total-autologous latissimus dorsi myocutaneous flaps in breast reconstruction. It addresses the indications for use of this reconstruction alternative, which have recently been expanded thanks to the advent of high-volume fat grafting. Given its straightforward dissection, reliable vascular pedicle, variety of approaches, and potential for excellent aesthetic results, use of latissimus dorsi flaps may be considered among first-line options in selected patients. Copyright © 2017 Elsevier Inc. All rights reserved.

Translations on Telecommunications Policy, Research and Development No. 24.

DTIC Science & Technology

1977-12-19

state enterprises for connecting the microwave systems of Brazil and Argentina, with a view to facilitating transmissions televised from the Copa do... Mundo and expanding the permanent capacity of the communications services of the two countries exclusively by the Intelsat satellite. Correa de

Seckel syndrome with severe sinus bradycardia.

PubMed

Ramasamy, Chandramohan; Satheesh, Santhosh; Selvaraj, Raja

2015-03-01

Seckel syndrome is an uncommon form of microcephalic dwarfism. The authors report a young boy with Seckel syndrome who presented with severe sinus bradycardia with symptoms of syncope and presyncope. Implantation of a permanent pacemaker was necessary in view of the severe symptoms. Although uncommon, cardiac abnormalities have been rarely reported in Seckel syndrome. This is the one of the few reports of rhythm abnormalities in this condition.

Loading capacity of zirconia implant supported hybrid ceramic crowns.

PubMed

Rohr, Nadja; Coldea, Andrea; Zitzmann, Nicola U; Fischer, Jens

2015-12-01

Recently a polymer infiltrated hybrid ceramic was developed, which is characterized by a low elastic modulus and therefore may be considered as potential material for implant supported single crowns. The purpose of the study was to evaluate the loading capacity of hybrid ceramic single crowns on one-piece zirconia implants with respect to the cement type. Fracture load tests were performed on standardized molar crowns milled from hybrid ceramic or feldspar ceramic, cemented to zirconia implants with either machined or etched intaglio surface using four different resin composite cements. Flexure strength, elastic modulus, indirect tensile strength and compressive strength of the cements were measured. Statistical analysis was performed using two-way ANOVA (p=0.05). The hybrid ceramic exhibited statistically significant higher fracture load values than the feldspar ceramic. Fracture load values and compressive strength values of the respective cements were correlated. Highest fracture load values were achieved with an adhesive cement (1253±148N). Etching of the intaglio surface did not improve the fracture load. Loading capacity of hybrid ceramic single crowns on one-piece zirconia implants is superior to that of feldspar ceramic. To achieve maximal loading capacity for permanent cementation of full-ceramic restorations on zirconia implants, self-adhesive or adhesive cements with a high compressive strength should be used. Copyright © 2015 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

Temporary implant-supported prosthesis for immediate loading according to a chair-side concept: technical note and results from 37 consecutive cases.

PubMed

Ostman, Pär-Olov; Hellman, Mats; Sennerby, Lars; Wennerberg, Ann

2008-05-01

During the last years, focus has been paid to implant treatment using immediate function protocols, and different approaches to provide patients with temporary constructions have been presented. Most of these techniques involve dental technicians producing the temporary construction, for example, rebuilding existing dentures, acrylic bridges, etc. The purpose of this prospective clinical study was to evaluate the clinical outcome of a chair-side technique of a cost-effective temporary prosthesis. Fixture survival rate and risk of temporary bridge failure were analyzed. Thirty-seven partially or totally edentate patients (18 female and 19 male; mean age: 66.7 years) treated with chair-side manufactured temporary restorations (QuickBridge, BIOMET 3i, Palm Beach, Fl, USA) for immediate loading have been evaluated. The prostheses extended from two unit bridges supported by two implants to full-arch construction supported by six implants. The temporary prostheses were monitored from the day of surgery and delivery to the time of replacement with a permanent prosthetic construction 3 to 6 months later. No implants were lost during the observation time. One (3%) temporary prosthesis fractured and additional two (6%) loosened during the follow-up time. The study indicated that the tested chair-side concept for manufacturing of temporary prosthesis for immediate loading of dental implants is a viable approach.

Social media patient testimonials in implant dentistry: information or misinformation?

PubMed

Ho, Adrian; McGrath, Colman; Mattheos, Nikos

2017-07-01

This study aims to assess the educational value of YouTube patient testimonial videos in implant dentistry and qualitatively analyse the themes mentioned. Videos were sampled consecutively on YouTube, using the keywords "dental implant patients' testimonials experience," sorted "by relevance." Patient testimonials on dental implant treatment were examined. Inaudible or non-English videos were excluded. Four calibrated investigators scored the videos for educational content, using a matrix derived from the European Association for Osseointegration information booklet, and demographic details were recorded. Data were analysed qualitatively through inductive thematic analysis. A total of 202 videos were analysed (48 exclusions). Inter-examiner reliability was fair to moderate for informative statements and poor to substantial for misleading statements. A mean of 1.8 informative statements were made per video, compared with misleading, 0.5. Many topics were rarely mentioned, with 19/30 themes appearing fewer than 5% of videos. Patients often informed that implants could improve aesthetics and function, but were misleading on aspects of pain control. Some statements may heighten expectations or imply permanency of treatment. Balanced presentation in YouTube testimonials may be limited by bias of clinician-uploaded content. Greater magnitude and breadth of information would improve educational value. Many important parameters of implant therapy were overlooked, whilst information was often potentially misleading. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Dosimetric and radiobiological comparison of volumetric modulated arc therapy, high-dose rate brachytherapy, and low-dose rate permanent seeds implant for localized prostate cancer.

PubMed

Yang, Ruijie; Zhao, Nan; Liao, Anyan; Wang, Hao; Qu, Ang

2016-01-01

To investigate the dosimetric and radiobiological differences among volumetric modulated arc therapy (VMAT), high-dose rate (HDR) brachytherapy, and low-dose rate (LDR) permanent seeds implant for localized prostate cancer. A total of 10 patients with localized prostate cancer were selected for this study. VMAT, HDR brachytherapy, and LDR permanent seeds implant plans were created for each patient. For VMAT, planning target volume (PTV) was defined as the clinical target volume plus a margin of 5mm. Rectum, bladder, urethra, and femoral heads were considered as organs at risk. A 78Gy in 39 fractions were prescribed for PTV. For HDR and LDR plans, the dose prescription was D90 of 34Gy in 8.5Gy per fraction, and 145Gy to clinical target volume, respectively. The dose and dose volume parameters were evaluated for target, organs at risk, and normal tissue. Physical dose was converted to dose based on 2-Gy fractions (equivalent dose in 2Gy per fraction, EQD2) for comparison of 3 techniques. HDR and LDR significantly reduced the dose to rectum and bladder compared with VMAT. The Dmean (EQD2) of rectum decreased 22.36Gy in HDR and 17.01Gy in LDR from 30.24Gy in VMAT, respectively. The Dmean (EQD2) of bladder decreased 6.91Gy in HDR and 2.53Gy in LDR from 13.46Gy in VMAT. For the femoral heads and normal tissue, the mean doses were also significantly reduced in both HDR and LDR compared with VMAT. For the urethra, the mean dose (EQD2) was 80.26, 70.23, and 104.91Gy in VMAT, HDR, and LDR brachytherapy, respectively. For localized prostate cancer, both HDR and LDR brachytherapy were clearly superior in the sparing of rectum, bladder, femoral heads, and normal tissue compared with VMAT. HDR provided the advantage in sparing of urethra compared with VMAT and LDR. Copyright © 2016 American Association of Medical Dosimetrists. Published by Elsevier Inc. All rights reserved.

Dosimetric and radiobiological comparison of volumetric modulated arc therapy, high-dose rate brachytherapy, and low-dose rate permanent seeds implant for localized prostate cancer

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

Yang, Ruijie, E-mail: ruijyang@yahoo.com; Zhao, Nan; Liao, Anyan

To investigate the dosimetric and radiobiological differences among volumetric modulated arc therapy (VMAT), high-dose rate (HDR) brachytherapy, and low-dose rate (LDR) permanent seeds implant for localized prostate cancer. A total of 10 patients with localized prostate cancer were selected for this study. VMAT, HDR brachytherapy, and LDR permanent seeds implant plans were created for each patient. For VMAT, planning target volume (PTV) was defined as the clinical target volume plus a margin of 5 mm. Rectum, bladder, urethra, and femoral heads were considered as organs at risk. A 78 Gy in 39 fractions were prescribed for PTV. For HDR andmore » LDR plans, the dose prescription was D{sub 90} of 34 Gy in 8.5 Gy per fraction, and 145 Gy to clinical target volume, respectively. The dose and dose volume parameters were evaluated for target, organs at risk, and normal tissue. Physical dose was converted to dose based on 2-Gy fractions (equivalent dose in 2 Gy per fraction, EQD{sub 2}) for comparison of 3 techniques. HDR and LDR significantly reduced the dose to rectum and bladder compared with VMAT. The D{sub mean} (EQD{sub 2}) of rectum decreased 22.36 Gy in HDR and 17.01 Gy in LDR from 30.24 Gy in VMAT, respectively. The D{sub mean} (EQD{sub 2}) of bladder decreased 6.91 Gy in HDR and 2.53 Gy in LDR from 13.46 Gy in VMAT. For the femoral heads and normal tissue, the mean doses were also significantly reduced in both HDR and LDR compared with VMAT. For the urethra, the mean dose (EQD{sub 2}) was 80.26, 70.23, and 104.91 Gy in VMAT, HDR, and LDR brachytherapy, respectively. For localized prostate cancer, both HDR and LDR brachytherapy were clearly superior in the sparing of rectum, bladder, femoral heads, and normal tissue compared with VMAT. HDR provided the advantage in sparing of urethra compared with VMAT and LDR.« less

The “curved lead pathway” method to enable a single lead to reach any two intracranial targets

NASA Astrophysics Data System (ADS)

Ding, Chen-Yu; Yu, Liang-Hong; Lin, Yuan-Xiang; Chen, Fan; Lin, Zhang-Ya; Kang, De-Zhi

2017-01-01

Deep brain stimulation is an effective way to treat movement disorders, and a powerful research tool for exploring brain functions. This report proposes a “curved lead pathway” method for lead implantation, such that a single lead can reach in sequence to any two intracranial targets. A new type of stereotaxic system for implanting a curved lead to the brain of human/primates was designed, the auxiliary device needed for this method to be used in rat/mouse was fabricated and verified in rat, and the Excel algorithm used for automatically calculating the necessary parameters was implemented. This “curved lead pathway” method of lead implantation may complement the current method, make lead implantation for multiple targets more convenient, and expand the experimental techniques of brain function research.

Long-range effect in nitrogen ion-implanted AISI 316L stainless steel

NASA Astrophysics Data System (ADS)

Budzynski, P.

2015-01-01

The effect of nitrogen ion implantation on AISI 316L stainless steel was investigated. The microstructure and composition of an N implanted layer were studied by RBS, GIXRD, SEM, and EDX measurements. Friction and wear tests were also performed. The discrepancy between the measured and calculated stopped ion maximum range does not exceed 0.03 μm. After nitrogen implantation with a fluence of 5 × 1017 ion/cm2, additional phases of expanded austenite were detected. At a 5-fold larger depth than the maximum ion range, improvement in the coefficient of friction and wear was detected. We have shown, for the first time, the long-range effect in tribological investigations. The long-range effect is caused by movement of not only defects along the depth of the sample, as assumed so far, but also nitrogen atoms.

Can the use of antibiotics interfere with the success of dental osseointegrated implants in diabetic patients?

PubMed

Borba, Alexandre Meireles; Souza, Daniel Falbo Martins; Brozoski, Mariana Aparecida; Burim, Rafael Augusto; Naclério-Homem, Maria da Graça; Deboni, Maria Cristina Zindel

2013-11-01

The present review aims to discuss the last 10 years published data on the topic of the use of osseointegrated implants in diabetic subjects, particularly regarding the influence of antibiotics administration in the perioperative period. In the last decades, oral rehabilitation significantly has evolved particularly with the use of osseointegrated implants. Increased life expectation of population is reflecting in a greater number of diabetic patients who might require dental osseointegrated implants rehabilitation. Diabetes was considered for a long time as a contraindication for oral implant placement. In this context, the use of antibiotics is still a controversial factor when we correlate it to implant success rate. Although 228 articles were initially selected for evaluation of proposed criteria, only 16 articles were considered valid. Among the 16 selected articles, only six articles represented clinical research that discussed the influence of the antibiotic in the success of osseointegration of dental implants in diabetic subjects. Five were retrospective studies and one a prospective research. Data favors the use of antibiotics without significant side effects but clinical investigations of the need of prophylaxis antibiotic or therapeutic antibiotics are still scarce. The lack of adequate methodology is one of the main problems of the current articles. It is important to emphasize that studies should present detailed methodology in order to allow reproducibility. Permanent tooth loss is a pathological condition that affects millions of people worldwide. The possibility of successful treatment of edentulous areas through osseointegrated implants in those systemic compromised patients is a matter of scientific discussion. Although antimicrobial agents must be used rationally and carefully to avoid development of bacterial resistance, more studies are needed in order to support evidence regarding the influence of antibiotics in the success of dental implant surgery in diabetic patients.

Three-dimensional (3D) printing and its applications for aortic diseases

PubMed Central

Hangge, Patrick; Pershad, Yash; Witting, Avery A.; Albadawi, Hassan

2018-01-01

Three-dimensional (3D) printing is a process which generates prototypes from virtual objects in computer-aided design (CAD) software. Since 3D printing enables the creation of customized objects, it is a rapidly expanding field in an age of personalized medicine. We discuss the use of 3D printing in surgical planning, training, and creation of devices for the treatment of aortic diseases. 3D printing can provide operators with a hands-on model to interact with complex anatomy, enable prototyping of devices for implantation based upon anatomy, or even provide pre-procedural simulation. Potential exists to expand upon current uses of 3D printing to create personalized implantable devices such as grafts. Future studies should aim to demonstrate the impact of 3D printing on outcomes to make this technology more accessible to patients with complex aortic diseases. PMID:29850416

Comparisons in Performance of Electromagnet and Permanent-Magnet Cylindrical Hall-Effect Thrusters

NASA Technical Reports Server (NTRS)

Polzin, K. A.; Raitses, Y.; Gayoso, J. C.; Fisch, N. J.

2010-01-01

Three different low-power cylindrical Hall thrusters, which more readily lend themselves to miniaturization and low-power operation than a conventional (annular) Hall thruster, are compared to evaluate the propulsive performance of each. One thruster uses electromagnet coils to produce the magnetic field within the discharge channel while the others use permanent magnets, promising power reduction relative to the electromagnet thruster. A magnetic screen is added to the permanent magnet thruster to improve performance by keeping the magnetic field from expanding into space beyond the exit of the thruster. The combined dataset spans a power range from 50-350 W. The thrust levels over this range were 1.3-7.3 mN, with thruster efficiencies and specific impulses spanning 3.5-28.7% and 400-1940 s, respectively. The efficiency is generally higher for the permanent magnet thruster with the magnetic screen, while That thruster s specific impulse as a function of discharge voltage is comparable to the electromagnet thruster.

Compression Molding and Novel Sintering Treatments for Alnico Type-8 Permanent Magnets in Near-Final Shape with Preferred Orientation

DOE PAGES

Kassen, Aaron G.; White, Emma M. H.; Tang, Wei; ...

2017-07-14

We present economic uncertainty in the rare earth (RE) permanent magnet marketplace, as well as in an expanding electric drive vehicle market that favors permanent magnet alternating current synchronous drive motors, motivated renewed research in RE-free permanent magnets like “alnico,” an Al-Ni-Co-Fe alloy. Thus, high-pressure, gas-atomized isotropic type-8H pre-alloyed alnico powder was compression molded with a clean burn-out binder to near-final shape and sintered to density >99% of cast alnico 8 (full density of 7.3 g/cm 3). To produce aligned sintered alnico magnets for improved energy product and magnetic remanence, uniaxial stress was attempted to promote controlled grain growth, avoidingmore » directional solidification that provides alignment in alnico 9. Lastly, successful development of solid-state powder processing may enable anisotropically aligned alnico magnets with enhanced energy density to be mass-produced.« less

Anesthesia for subcutaneous implantable cardioverter-defibrillator implantation: Perspectives from the clinical experience of a US panel of physicians.

PubMed

Essandoh, Michael K; Mark, George E; Aasbo, Johan D; Joyner, Charles A; Sharma, Saumya; Decena, Beningo F; Bolin, Eric D; Weiss, Raul; Burke, Martin C; McClernon, Timothy R; Daoud, Emile G; Gold, Michael R

2018-05-13

Worldwide adoption of the subcutaneous implantable cardioverter-defibrillator (S-ICD) for preventing sudden cardiac death continues to increase, as longer-term evidence demonstrating the safety and efficacy of the S-ICD expands. As a relatively new technology, comprehensive anesthesia guidance for the management of patients undergoing S-ICD placement is lacking. This article presents advantages and disadvantages of different peri-procedural sedation and anesthesia options for S-ICD implants including general anesthesia, monitored anesthesia care, regional anesthesia, and nonanesthesia personnel administered sedation and analgesia. Guidance, for approaches to anesthesia care during S-ICD implantation, are presented based upon literature review and consensus of a panel of high volume S-ICD implanters, a regional anesthesiologist, and a cardiothoracic anesthesiologist with significant S-ICD experience. The panel developed suggested actions for perioperative sedation, anesthesia, surgical practices and a decision algorithm for S-ICD implantation. While S-ICD implantation currently requires higher sedation than transvenous ICD systems, the panel consensus is that general anesthesia is not required or is obligatory for the majority of patients for the experienced S-ICD implanter. The focus of the implanting physician and the anesthesia services should be to maximize patient comfort and take into consideration patient specific co-morbidities, with a low threshold to consult the anesthesiology team. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

The In Vivo Pericapsular Tissue Response to Modern Polyurethane Breast Implants.

PubMed

Frame, James; Kamel, Dia; Olivan, Marcelo; Cintra, Henrique

2015-10-01

Polyurethane breast implants were first introduced by Ashley (Plast Reconstr Surg 45:421-424, 1970), with the intention of trying to reduce the high incidence of capsular contracture associated with smooth shelled, high gel bleed, silicone breast implants. The sterilization of the polyurethane foam in the early days was questionable. More recently, ethylene oxide (ETO)-sterilized polyurethane has been used in the manufacturing process and this has been shown to reduce the incidence of biofilm. The improved method of attachment of polyurethane onto the underlying high cohesive gel, barrier shell layered, silicone breast implants also encourages bio-integration. Polyurethane covered, cohesive gel, silicone implants have also been shown to reduce the incidence of other problems commonly associated with smooth or textured silicone implants, especially with reference to displacement, capsular contracture, seroma, reoperation, biofilm and implant rupture. Since the introduction of the conical polyurethane implant (Silimed, Brazil) into the United Kingdom in 2009 (Eurosurgical, UK), we have had the opportunity to review histology taken from the capsules of polyurethane implants in three women ranging from a few months to over 3 years after implantation. All implants had been inserted into virgin subfascial, extra-pectoral planes. The results add to the important previously described histological findings of Bassetto et al. (Aesthet Plast Surg 34:481-485, 2010). Five distinct layers are identified and reasons for the development of each layer are discussed. Breast capsule around polyurethane implants, in situ for fifteen and 20 years, has recently been obtained and analysed in Brazil, and the histology has been incorporated into this study. After 20 years, the polyurethane is almost undetectable and capsular contracture may appear. These findings contribute to our understanding of polyurethane implant safety, and give reasoning for a significant reduction in clinical capsular contracture rate, up to 10 years after implantation, compared to contemporary silicone implants. A more permanent matrix equivalent to polyurethane may be the solution for reducing long-term capsular contracture. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Permanency and the Foster Care System.

PubMed

Lockwood, Katie K; Friedman, Susan; Christian, Cindy W

2015-10-01

Each year over 20,000 youth age out of the child welfare system without reaching a permanent placement in a family. Certain children, such as those spending extended time in foster care, with a diagnosed disability, or adolescents, are at the highest risk for aging out. As young adults, this population is at and increased risk of incarceration; food, housing, and income insecurity; unemployment; educational deficits; receipt of public assistance; and mental health disorders. We reviewed the literature on foster care legislation, permanency, outcomes, and interventions. The outcomes of children who age out of the child welfare system are poor. Interventions to increase permanency include training programs for youth and foster parents, age extension for foster care and insurance coverage, an adoption tax credit, and specialized services and programs that support youth preparing for their transition to adulthood. Future ideas include expanding mentoring, educational support, mental health services, and post-permanency services to foster stability in foster care placements and encourage permanency planning. Children in the child welfare system are at a high risk for physical, mental, and emotional health problems that can lead to placement instability and create barriers to achieving permanency. Failure to reach the permanency of a family leads to poor outcomes, which have negative effects on the individual and society. Supporting youth in foster care throughout transitions may mediate the negative outcomes that have historically followed placement in out-of-home care. Copyright © 2015 Mosby, Inc. All rights reserved.

The immediate and short-term effects of bilateral intrahippocampal depth electrodes on verbal memory.

PubMed

Helmstaedter, Christoph; Gielen, Gerrit H; Witt, Juri-Alexander

2018-06-01

In contrast to previous studies, Ljung et al. provide evidence of permanent cognitive consequences of bilateral intrahippocampal depth electrodes for verbal memory in patients who were not operated or operated in the right temporal lobe. Stimulated by this, we provide historical confirmatory and supplementary evidence of the detrimental effect of bilateral depth electrodes implanted along the longitudinal axis of the hippocampus on verbal learning and especially on delayed verbal memory and recognition performance. This is demonstrated in 31 patients with memory assessments before implantation, after explantation, and 3 months later after left/right temporal lobe surgery. After surgery, significant recovery from postimplantation impairment is found in right temporal patients. Left temporal resection patients stay on the level seen after implantation and do not recover. Surgery, however, has its own effects in addition to the implantation. Intracranial electrodes for electroencephalographic monitoring or electrical stimulation are commonly and increasingly used for diagnosis or treatment in pharmacoresistant epilepsies. Thus, the monitoring of invasive stereotactic approaches is recommended to find safe procedures for the patients. In response to the findings, we restricted indications and used different implantation schemes, different trajectories, and targets to minimize the risk of additional damage. Wiley Periodicals, Inc. © 2018 International League Against Epilepsy.

Plasma-deposited fluorocarbon polymer films on titanium for preventing cell adhesion: a surface finishing for temporarily used orthopaedic implants

NASA Astrophysics Data System (ADS)

Finke, B.; Testrich, H.; Rebl, H.; Walschus, U.; Schlosser, M.; Zietz, C.; Staehlke, S.; Nebe, J. B.; Weltmann, K. D.; Meichsner, J.; Polak, M.

2016-06-01

The design of a titanium implant surface should ideally support its later application in clinical use. Temporarily used implants have to fulfil requirements different from permanent implants: they should ensure the mechanical stabilization of the bone stock but in trauma surgery they should not be integrated into the bone because they will be removed after fracture healing. Finishing of the implant surface by a plasma-fluorocarbon-polymer (PFP) coating is a possible approach for preventing cell adhesion of osteoblasts. Two different low pressure gas-discharge plasma processes, microwave (MW 2.45 GHz) and capacitively coupled radio frequency (RF 13.56 MHz) plasma, were applied for the deposition of the PFP film using a mixture of the precursor octafluoropropane (C3F8) and hydrogen (H2). The thin films were characterized by x-ray photoelectron spectroscopy, Fourier transform infrared reflection absorption spectroscopy, and water contact angle measurements. Cell culture experiments show that cell adhesion and spreading of MG-63 osteoblasts were clearly reduced or nonexistent on these surfaces, also after 24 h of storage in the cell culture medium. In vivo data demonstrated that the local inflammatory tissue response for the PFP films deposited in MW and RF plasma were comparable to uncoated controls.

Cardiac Conduction through Engineered Tissue

PubMed Central

Choi, Yeong-Hoon; Stamm, Christof; Hammer, Peter E.; Kwaku, Kevin F.; Marler, Jennifer J.; Friehs, Ingeborg; Jones, Mara; Rader, Christine M.; Roy, Nathalie; Eddy, Mau-Thek; Triedman, John K.; Walsh, Edward P.; McGowan, Francis X.; del Nido, Pedro J.; Cowan, Douglas B.

2006-01-01

In children, interruption of cardiac atrioventricular (AV) electrical conduction can result from congenital defects, surgical interventions, and maternal autoimmune diseases during pregnancy. Complete AV conduction block is typically treated by implanting an electronic pacemaker device, although long-term pacing therapy in pediatric patients has significant complications. As a first step toward developing a substitute treatment, we implanted engineered tissue constructs in rat hearts to create an alternative AV conduction pathway. We found that skeletal muscle-derived cells in the constructs exhibited sustained electrical coupling through persistent expression and function of gap junction proteins. Using fluorescence in situ hybridization and polymerase chain reaction analyses, myogenic cells in the constructs were shown to survive in the AV groove of implanted hearts for the duration of the animal’s natural life. Perfusion of hearts with fluorescently labeled lectin demonstrated that implanted tissues became vascularized and immunostaining verified the presence of proteins important in electromechanical integration of myogenic cells with surrounding recipient rat cardiomyocytes. Finally, using optical mapping and electrophysiological analyses, we provide evidence of permanent AV conduction through the implant in one-third of recipient animals. Our experiments provide a proof-of-principle that engineered tissue constructs can function as an electrical conduit and, ultimately, may offer a substitute treatment to conventional pacing therapy. PMID:16816362

First percutaneous Micra leadless pacemaker implantation and tricuspid valve repair with MitraClip NT for lead-associated severe tricuspid regurgitation.

PubMed

Tang, Gilbert H L; Kaple, Ryan; Cohen, Martin; Dutta, Tanya; Undemir, Cenap; Ahmad, Hasan; Poniros, Angelica; Bennett, Joanne; Feng, Cheng; Lansman, Steven

2017-02-03

Pacemaker lead-associated severe tricuspid regurgitation (TR) can lead to right heart failure and poor prognosis. Surgery in these patients carries significant morbidities. We describe a successful treatment of symptomatic severe TR by leadless pacemaker implantation followed by tricuspid valve (TV) repair with the MitraClip NT. A 71-year-old frail female with poor functional status, chronic atrial fibrillation and permanent pacemaker implantation in 2012 presented with symptomatic moderate-severe mitral regurgitation (MR) and severe TR with the pacemaker lead as the culprit. She was deemed extreme risk for double valve surgery and, because of her pacemaker dependency, the decision was to stage her interventions first with transcatheter mitral repair, then laser lead extraction and leadless pacemaker implantation to free the TV from tethering, then TV repair. An obstructive LAD lesion was identified and treated during mitral repair with the MitraClip NT. The Micra leadless pacemaker implantation and subsequent TV repair with the MitraClip NT were successful and the patient's MR improved to mild and TR to moderate, respectively. We report here a first successful transcatheter strategy to treat lead-associated severe TR by leadless pacemaker and MitraClip. Removing the pacemaker lead relieved leaflet tethering and improved the reparability of the TV.

Opportunities and challenges for the biodegradable magnesium alloys as next-generation biomaterials

PubMed Central

Ding, Wenjiang

2016-01-01

In recent years, biodegradable magnesium alloys emerge as a new class of biomaterials for tissue engineering and medical devices. Deploying biodegradable magnesium-based materials not only avoids a second surgical intervention for implant removal but also circumvents the long-term foreign body effect of permanent implants. However, these materials are often subjected to an uncontrolled and fast degradation, acute toxic responses and rapid structural failure presumably due to a localized, too rapid corrosion process. The patented Mg–Nd–Zn–based alloys (JiaoDa BioMg [JDBM]) have been developed in Shanghai Jiao Tong University in recent years. The alloy series exhibit lower biodegradation rate and homogeneous nanophasic degradation patterns as compared with other biodegradable Mg alloys. The in vitro cytotoxicity tests using various types of cells indicate excellent biocompatibility of JDBM. Finally, bone implants using JDBM-1 alloy and cardiovascular stents using JDBM-2 alloy have been successfully fabricated and in vivo long-term assessment via implantation in animal model have been performed. The results confirmed the reduced degradation rate in vivo, excellent tissue compatibility and long-term structural and mechanical durability. Thus, this novel Mg-alloy series with highly uniform nanophasic biodegradation represent a major breakthrough in the field and a promising candidate for manufacturing the next generation biodegradable implants. PMID:27047673

The use of expandable metallic airway stents for tracheobronchial obstruction in children.

PubMed

Filler, R M; Forte, V; Fraga, J C; Matute, J

1995-07-01

Expandable metallic angioplasty stents (Palmaz stent) have been implanted in the trachea and/or bronchi of seven children. Three children had severe tracheal stenosis after tracheoplasty for congenital tracheal stenosis repair, and four had tracheomalacia or bronchomalacia with or without vascular compression. The mean age at stenting was 9.7 months (range, 2 to 15 months). Balloon expandable stents were inserted into the trachea or bronchus through a 3.5-mm bronchoscope under fluoroscopic control. Initially a single tracheal stent was used for all patients except for one with obstruction in the trachea and both bronchi, in whom three stents were implanted. Three children had recurrent airway obstruction 1 month later; one was cured with a second stent; one child died 1 year later; and the other is being treated for heart disease. The others have no serious respiratory problems. The stents in all have been in place for 1 to 25 (mean, 11) months. No immediate complications were noted. Early and late bronchoscopy showed incomplete epithelialization of the stent and patches of granulation tissue on it. Two stents were removed bronchoscopically, one at the completion of treatment for tracheomalacia and the other at the time of recurrent airway obstruction. This preliminary experience indicates that expandable metallic stents have a useful role in the treatment of selected lower airway obstructions.

Human Exploration and Development of Space: Strategic Plan

NASA Technical Reports Server (NTRS)

Branscome, Darrell (Editor); Allen, Marc (Editor); Bihner, William (Editor); Craig, Mark (Editor); Crouch, Matthew (Editor); Crouch, Roger (Editor); Flaherty, Chris (Editor); Haynes, Norman (Editor); Horowitz, Steven (Editor)

2000-01-01

The five goals of the Human Exploration and Development of Space include: 1) Explore the Space Frontier; 2) Expand Scientific Knowledge; 3) Enable Humans to Live and Work Permanently in Space; 4) Enable the Commercial Development of Space; and 5) Share the Experience and Benefits of Discovery.

Immediate two-stage prosthetic breast reconstruction failure: radiation is not the only culprit.

PubMed

Lam, Thomas C; Borotkanics, Robert; Hsieh, Frank; Salinas, James; Boyages, John

2018-03-15

Immediate prosthetic breast reconstruction produces a satisfactory aesthetic result with high levels of patient satisfaction. However, with the broader indication for post-mastectomy adjuvant radiation, many patients are advised against immediate breast reconstruction because of concerns of implant loss and infection particularly as most patients also require chemotherapy. This retrospective cohort study examines outcomes for patients who underwent immediate two-stage prosthetic breast reconstruction after mastectomy with or without adjuvant chemotherapy or radiotherapy (RT). Between 1998 and 2010, 452 patients undergoing two-stage prosthetic immediate breast reconstruction involving a total of 562 breasts were included in this study. Stage one was defined as insertion of the temporary expander and stage two insertion of the final silicone implant. Post-operative adjuvant radiotherapy was recommended with tissue expander in-situ for 114 patients. Complications, including loss of prosthesis, seroma and infection were recorded and analysed. Cosmetic result was assessed using a 4-point scale. Post-operative prosthesis loss was 2.7%, 5.3% for patients undergoing adjuvant chemotherapy increasing to 11.3% for patients receiving chemotherapy+RT. Chemotherapy and radiotherapy independently were the main, statistically significant, risk factors for expander or implant loss; IRR: 13.85 (p=0.012) and 2.23 (p=0.027), respectively. Prosthesis loss for patients undergoing combination chemotherapy+RT was also significant; IRR: 4.791 (p<0.001). These findings serve to better inform patients on risk in weighing treatment options. Post-mastectomy radiation doubles the risk of prosthesis loss over and above adjuvant chemotherapy but is an acceptable option following immediate prosthetic breast reconstruction in a multidisciplinary setting.

Preshock region acceleration of implanted cometary H(+) and O(+)

NASA Astrophysics Data System (ADS)

Gombosi, T. I.

1988-01-01

A self-consistent, three-fluid model of plasma transport and implanted ion acceleration in the unshocked solar wind is presented. The solar wind plasma is depleted by charge exchange with the expanding cometary exosphere, while implanted protons and heavy ions are produced by photoionization and charge transfer and lost by charge exchange. A generalized transport equation describing convection, adiabatic and diffusive velocity change, and the appropriate production terms is used to describe the evolution of the two cometary ion components, while the moments of the Boltzmann equation are used to calculate the solar wind density and pressure. The flow velocity is obtained self-consistently by combining the conservation equations of the three ion species. The results imply that second-order Fermi acceleration can explain the implanted spectra observed in the unshocked solar wind. Comparison of measured and calculated distribution indicates that spatial diffusion of implanted ions probably plays an important role in forming the energetic particle environment in the shock vicinity.

The Use of Carbon-Fiber-Reinforced (CFR) PEEK Material in Orthopedic Implants: A Systematic Review

PubMed Central

Li, Chuan Silvia; Vannabouathong, Christopher; Sprague, Sheila; Bhandari, Mohit

2015-01-01

Carbon-fiber-reinforced polyetheretherketone (CFR-PEEK) has been successfully used in orthopedic implants. The aim of this systematic review is to investigate the properties, technical data, and safety of CFR-PEEK biomaterial and to evaluate its potential for new innovation in the design of articulating medical devices. A comprehensive search in PubMed and EMBASE was conducted to identify articles relevant to the outcomes of CFR-PEEK orthopedic implants. The search was also expanded by reviewing the reference sections of selected papers and references and benchmark reports provided by content experts. A total of 23 articles were included in this review. There is limited literature available assessing the performance of CFR-PEEK, specifically as an implant material for arthroplasty systems. Nevertheless, available studies strongly support CFR-PEEK as a promising and suitable material for orthopedic implants because of its biocompatibility, material characteristics, and mechanical durability. Future studies should continue to investigate CFR-PEEK’s potential benefits. PMID:25780341

Lessons learnt from the introduction of the contraceptive implant in South Africa

PubMed

Pleaner, M; Morroni, C; Smit, J; Lince-Deroche, N; Chersich, M; Mullick, S; Pillay, D; Makua, M; Rees, H

2017-10-01

In 2014, South Africa (SA) introduced the subdermal contraceptive implant with the aim of expanding the contraceptive method mix and availability of long-acting reversible methods in the public sector. Three years on, concerns have been raised about the decline in uptake, early implant removals and challenges in service delivery. This article explores the lessons learnt from the introduction of contraceptive technologies elsewhere and applies these to the SA context. Drawing on the World Health Organization’s conceptual framework for the introduction of new contraceptive methods, and subsequent literature on the topic, lessons are classified into six cross-cutting themes. Recommendations highlight the need for SA to review and explore strategies to strengthen current implant services, including the provision of improved provider training aimed at sensitive, client-centred approaches; increased community engagement; and improved systems for programmatic monitoring and evaluation. With implementation of these recommendations, worrying trends in the provision of implants could be reversed. Creative Commons Attribution - NonCommercial Works License (CC BY-NC 4.0)

Ventricular fibrillation in an ambulatory patient supported by a left ventricular assist device: highlighting the ICD controversy.

PubMed

Boilson, Barry A; Durham, Lucian A; Park, Soon J

2012-01-01

Left ventricular assist devices (LVADs) provide an effective means of managing advanced pump failure as a means of bridging to cardiac transplantation or as permanent therapy. Although ventricular arrhythmias remain common post-LVAD implantation, such therapy may allow malignant arrhythmias to be tolerated hemodynamically. This report describes the clinical findings in a patient who had likely been in a ventricular tachyarrhythmia for several days and presented in ventricular fibrillation, ambulatory, and mentating normally. This report, with previous similar reports, is additive to the body of evidence that LVADs alter the physiologic impact of ventricular arrhythmias in advanced heart failure and highlights the need for thoughtful programming of implantable cardioverter defibrillator therapies in these patients.

Self-Expanding Versus Balloon-Expandable Stents for Iliac Artery Occlusive Disease: The Randomized ICE Trial.

PubMed

Krankenberg, Hans; Zeller, Thomas; Ingwersen, Maja; Schmalstieg, Josefin; Gissler, Hans Martin; Nikol, Sigrid; Baumgartner, Iris; Diehm, Nicolas; Nickling, Estell; Müller-Hülsbeck, Stefan; Schmiedel, Rainer; Torsello, Giovanni; Hochholzer, Willibald; Stelzner, Christian; Brechtel, Klaus; Ito, Wulf; Kickuth, Ralph; Blessing, Erwin; Thieme, Marcus; Nakonieczny, Jaroslaw; Nolte, Thomas; Gareis, Ragnar; Boden, Harald; Sixt, Sebastian

2017-08-28

Atherosclerosis of iliac arteries is widespread. As inflow vessels, they are of great clinical significance and increasingly being treated by endovascular means. Most commonly, stents are implanted. So far, due to a lack of comparative data, no guideline recommendations on the preferable stent type, balloon-expandable stent (BE) or self-expanding stent (SE), have been issued. In this randomized, multicenter study, patients with moderate to severe claudication from common or external iliac artery occlusive disease were assigned 1:1 to either BE or SE. The primary endpoint was binary restenosis at 12 months as determined by duplex ultrasound. Key secondary endpoints were walking impairment, freedom from target lesion revascularization (TLR), hemodynamic success, target limb amputation, and all-cause death. Six hundred sixty patients with 660 lesions were enrolled at 18 German and Swiss sites over a period of 34 months; 24.8% of the patients had diabetes and 57.4% were current smokers. The common iliac artery was affected in 58.9%. One hundred nine (16.5%) lesions were totally occluded and 25.6% heavily calcified. Twelve-month incidence of restenosis was 6.1% after SE implantation and 14.9% after BE implantation (p = 0.006). Kaplan-Meier estimate of freedom from TLR was 97.2% and 93.6%, respectively (p = 0.042). There was no between-group difference in walking impairment, hemodynamic success, amputation rate, all-cause death, or periprocedural complications. The treatment of iliac artery occlusive disease with SE as compared with BE resulted in a lower 12-month restenosis rate and a significantly reduced TLR rate. No safety concerns arose in both groups. (Iliac, Common and External [ICE] Artery Stent Trial; NCT01305174). Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Self-expanding nanoplatinum-coated nitinol devices for atrial septal defect and patent ductus arteriosus closure: a swine model.

PubMed

Lertsapcharoen, Pornthep; Khongphatthanayothin, Apichai; La-orkhun, Vidhavas; Supachokchaiwattana, Pentip; Charoonrut, Phingphol

2006-01-01

Our purpose was to evaluate self-expanding nanoplatinum-coated nitinol devices for transcatheter closure of atrial septal defects and patent ductus arteriosus in a swine model. The devices were braided from platinum-activated nitinol wires and filled with polyester to enhance thrombogenicity. The platinum activation of the nitinol wires was carried out with the help of Nanofusion technology. The coating of platinum covers the exposed surface of the nitinol wires and prevents the release of nickel into the blood stream after the implantation of the device but does not affect its shape memory, which makes the device self-expanding after it is loaded from the catheter. Atrial septal defects were created in 12 piglets by balloon dilation of the patent foramen ovale. The size of the device was selected on the basis of the diameter of the balloon and the size of the defect, measured by transthoracic echocardiography. The devices were successfully deployed in all 12 piglets under fluoroscopic study. Transthoracic color Doppler echocardiograms showed complete closure of the atrial septal defect within 15 minutes of device implantation. Twelve patent ductus arteriosus closure devices were deployed in the right or left subclavian arteries in 10 piglets. Angiograms showed complete occlusion of the subclavian arteries within a few minutes of device deployment. In the atrial septal defect cases, the autopsy findings showed complete organizing fibrin thrombus formation and complete neo-endothelialization on the outer surface of the devices within one week and six weeks of implantation, respectively. The use of self-expanding nanoplatinum-coated nitinol devices for the transcatheter closure of atrial septal defects and patent ductus arteriosus is feasible. The excellent occlusion result and complete neo-endothelialization of the devices in the swine model is an indication of the potential of these devices in human application.

Percutaneous implantation of the CoreValve® self-expanding valve prosthesis in patients with severe aortic stenosis and porcelain aorta: medium-term follow-up.

PubMed

Pascual, Isaac; Avanzas, Pablo; Muñoz-García, Antonio J; López-Otero, Diego; Jimenez-Navarro, Manuel F; Cid-Alvarez, Belén; del Valle, Raquel; Alonso-Briales, Juan H; Ocaranza-Sanchez, Raimundo; Alfonso, Fernando; Hernández, José M; Trillo-Nouche, Ramiro; Morís, César

2013-10-01

There is little information on the use of transcatheter aortic valve implantation in patients with severe aortic stenosis and porcelain aorta. The primary aim of this study was to analyze death from any cause after CoreValve(®) implantation in patients with severe aortic stenosis, with and without porcelain aorta. In this multicenter, observational prospective study, carried out in 3 hospitals, percutaneous aortic valves were implanted in 449 patients with severely calcified aortic stenosis. Of these, 36 (8%) met the criteria for porcelain aorta. The primary end-point was death from any cause at 2 years. Patients with porcelain aorta more frequently had extracardiac vascular disease (11 [30.6%] vs 49 [11.9%]; P=.002), prior coronary revascularization (15 [41.7%] vs 98 [23.7%]; P=.017), and dyslipidemia (26 [72.2%] vs 186 [45%]; P=.02). In these patients, there was greater use of general anesthesia (15 [41.7%] vs 111 [16.9%]; P=.058) and axillary access (9 [25%] vs 34 [8.2%]; P=.004). The success rate of the procedure (94.4 vs 97.3%; P=.28) and the incidence of complications (7 [19.4%] vs 48 [11.6%]; P=.20) were similar in both groups. There were no statistically significant differences in the primary end point at 24 months of follow-up (8 [22.2%] vs 66 [16%]; P=.33). The only predictive variable for the primary end point was the presence of complications during implantation (hazard ratio=2.6; 95% confidence interval, 1.5-4.5; P=.001). In patients with aortic stenosis and porcelain aorta unsuitable for surgery, percutaneous implantation of the CoreValve(®) self-expanding valve prosthesis is safe and feasible. Copyright © 2013 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

Coated and uncoated self-expanding metal stents for malignant stenosis in the upper GI tract: preliminary clinical experiences with Wallstents.

PubMed

Ell, C; Hochberger, J; May, A; Fleig, W E; Hahn, E G

1994-09-01

The clinical feasibility of self-expanding metal stents with respect to the technical success, complications, and reintervention rate should be tested. Five coated and 26 uncoated prototype Wallstents, especially designed for stenosis of the upper GI tract, were implanted in 23 patients. All patients with dysphagia suffered from inoperable tumor stenosis of the esophagus or the cardia. Stent implantation was performed under slight i.v. sedoanalgesia. Technical success was achieved in all 31 implanted stents. Forty-eight hr after implantation, dysphagia was improved in 21/23 patients. Acute problems observed within 1 wk were stent migration (1 patient, uncoated stent), oblique position of the stent (3 patients), epigastric or retrosternal pain (9 patients), insufficient stent expansion (4 patients), and pouch formation at the upper rim of the stent (4 patients). An uncomplicated follow-up (median 66 days, range 10-139 days) was seen in 12 patients (52%). Major problems in the follow-up period were stent migration in three patients (three coated stents, two stent migrations in one patient) and stent obstruction by tumor ingrowth/overgrowth and/or food impaction in eight patients (35%). Most of these problems could be successfully resolved by implantation of a second stent or electrocoagulation of overgrowing tumor tissue. By the 1st of March, 1994, three patients were still alive with a follow-up period of 530 days (median range, 336-880 days); 20 patients were decreased with a follow-up period of 70 days (median range, 3-374 days). Implantation of esophageal Wallstents is safe and has a low risk of acute complications and mortality for the patient. Early complications such as perforation and bleeding did not occur. Tumor ingrowth/overgrowth are the major reasons for the high reintervention rate in the follow-up period. Coated stents can resolve this problem, provided that stent migration can be avoided by improvement of the coating technology.

Predictive ability of the CHADS2 and CHA2DS2-VASc scores for stroke after transcatheter aortic balloon-expandable valve implantation: an Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER) sub-analysis.

PubMed

Conrotto, Federico; D'Ascenzo, Fabrizio; D'Onofrio, Augusto; Agrifoglio, Marco; Chieffo, Alaide; Cioni, Micaela; Regesta, Tommaso; Tarantini, Giuseppe; Gabbieri, Davide; Saia, Francesco; Tamburino, Corrado; Ribichini, Flavio; Cugola, Diego; Aiello, Marco; Sanna, Francesco; Iadanza, Alessandro; Pompei, Esmeralda; Stolcova, Miroslava; Cappai, Antioco; Minati, Alessandro; Cassese, Mauro; Martinelli, Gian Luca; Agostinelli, Andrea; Gerosa, Gino; Gaita, Fiorenzo; Rinaldi, Mauro; Salizzoni, Stefano

2016-11-01

Stroke incidence after transcatheter aortic valve implantation (TAVI) still represents a concern. This multicentre study aimed at investigating the hypothesis that CHADS2 and CHA2DS2-VASc scores may be used to predict perioperative stroke after TAVI. The Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER) is a multicentre, prospective registry of patients undergoing balloon-expandable TAVI using Edwards Sapien and Sapien XT prosthesis between 2007 and 2012. The primary end-point of this study was the 30-day stroke rate. Secondary safety end-points were all the major adverse events based on Valve Academic Research Consortium (VARC-2) criteria. One thousand nine hundred and four patients were enrolled in the registry. Mean age was 81.6 ± 6.2 years and 1147 (60.2%) patients were female; mean CHADS 2 and CHA 2 DS 2 -VASc scores were 2.2 ± 0.8 and 4.4 ± 1.1, respectively. Fifty-four (2.8%) patients had a stroke within 30 days. At multivariable logistic regression analysis, CHA 2 DS 2 -VASc (OR: 1.35, 95% CI: 1.03-1.78; P = 0.031) and previous cardiac surgery (OR: 1.96, 95% CI: 1.06-3.6; P = 0.033) but not CHADS 2 (OR: 1.05, 95% CI: 0.76-1.44; P = 0.77) were found to be independent predictors of in-hospital stroke. A CHA 2 DS 2 -VASc score ≥5 was strongly related to the occurrence of in-hospital stroke (OR: 2.51, 95% CI: 1.38-4.57; P= 0.001). However, CHA 2 DS 2 -VASc score showed only poor accuracy for in-hospital stroke with a trend for better accuracy when compared with CHADS 2 score (area under the curve: 0.61, 95% CI: 0.59-0.63 vs 0.51; 95% CI: 0.49-0.54, respectively, P = 0.092). In TAVI patients, CHA 2 DS 2 -VASc provided a strong correlation for in-hospital stroke but with low accuracy. Dedicated scores to properly tailor procedures and preventive strategies are needed. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

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

Kassen, Aaron G.; White, Emma M. H.; Tang, Wei

We present economic uncertainty in the rare earth (RE) permanent magnet marketplace, as well as in an expanding electric drive vehicle market that favors permanent magnet alternating current synchronous drive motors, motivated renewed research in RE-free permanent magnets like “alnico,” an Al-Ni-Co-Fe alloy. Thus, high-pressure, gas-atomized isotropic type-8H pre-alloyed alnico powder was compression molded with a clean burn-out binder to near-final shape and sintered to density >99% of cast alnico 8 (full density of 7.3 g/cm 3). To produce aligned sintered alnico magnets for improved energy product and magnetic remanence, uniaxial stress was attempted to promote controlled grain growth, avoidingmore » directional solidification that provides alignment in alnico 9. Lastly, successful development of solid-state powder processing may enable anisotropically aligned alnico magnets with enhanced energy density to be mass-produced.« less

Sick sinus syndrome as a complication of mediastinal radiation therapy

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

Pohjola-Sintonen, S.; Toetterman, K.J.K.; Kupari, M.

1990-06-01

A 33-year-old man who had received mediastinal radiation therapy for Hodgkin's disease 12 years earlier developed a symptomatic sick sinus syndrome requiring the implantation of a permanent pacemaker. The sick sinus syndrome and a finding of an occult constrictive pericarditis were considered to be due to the previous mediastinal irradiation. A ventricular pacemaker was chosen because mediastinal radiotherapy also increases the risk of developing atrioventricular conduction defects.

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.

Automatic determination of optimal linear drilling trajectories for cochlear access accounting for drill-positioning error.

PubMed

Noble, Jack H; Majdani, Omid; Labadie, Robert F; Dawant, Benoit; Fitzpatrick, J Michael

2010-09-01

Cochlear implantation is a surgical procedure in which an electrode array is permanently implanted into the cochlea to stimulate the auditory nerve and allow deaf people to hear. Percutaneous cochlear access, a new minimally invasive implantation approach, requires drilling a single linear channel from the skull surface to the cochlea. The focus of this paper addresses a major challenge with this approach, which is the ability to determine, in a pre-operative CT, a safe and effective drilling trajectory. A measure of the safety and effectiveness of a given trajectory relative to sensitive structures is derived using a Monte Carlo approach. The drilling trajectory that maximizes this measure is found using an optimization algorithm. In tests on 13 ears, the technique was shown to find approximately twice as many acceptable trajectories as those found manually by an experienced surgeon. Using this method, safe trajectories can be automatically determined quickly and consistently. Copyright 2010 John Wiley & Sons, Ltd.

Candida and cardiovascular implantable electronic devices: a case of lead and native aortic valve endocarditis and literature review.

PubMed

Glavis-Bloom, Justin; Vasher, Scott; Marmor, Meghan; Fine, Antonella B; Chan, Philip A; Tashima, Karen T; Lonks, John R; Kojic, Erna M

2015-11-01

Use of cardiovascular implantable electronic devices (CIED), including permanent pacemakers (PPM) and implantable cardioverter defibrillators (ICD), has increased dramatically over the past two decades. Most CIED infections are caused by staphylococci. Fungal causes are rare and their prognosis is poor. To our knowledge, there has not been a previously reported case of multifocal Candida endocarditis involving both a native left-sided heart valve and a CIED lead. Here, we report the case of a 70-year-old patient who presented with nausea, vomiting, and generalised fatigue, and was found to have Candida glabrata endocarditis involving both a native aortic valve and right atrial ICD lead. We review the literature and summarise four additional cases of CIED-associated Candida endocarditis published from 2009 to 2014, updating a previously published review of cases prior to 2009. We additionally review treatment guidelines and discuss management of CIED-associated Candida endocarditis. © 2015 Blackwell Verlag GmbH.

Urethral toxicity after LDR brachytherapy: experience in Japan.

PubMed

Tanaka, Nobumichi; Asakawa, Isao; Hasegawa, Masatoshi; Fujimoto, Kiyohide

2015-01-01

Urinary toxicity is common after low-dose-rate (LDR) brachytherapy, and the resolution of urinary toxicity is a concern. In particular, urinary frequency is the most common adverse event among the urinary toxicities. We have previously reported that approximately 70% of patients experience urinary frequency during the first 6 months after seed implantation. Most urinary adverse events were classified as Grade 1, and Grade 2 or higher adverse events were rare. The incidence of urinary retention was approximately 2-4%. A high International Prostate Symptom Score before seed implantation was an independent predictor of acute urinary toxicity of Grade 2 or higher. Several previous reports from the United States also supported this trend. In Japan, LDR brachytherapy was legally approved in 2003. A nationwide prospective cohort study entitled Japanese Prostate Cancer Outcome Study of Permanent Iodine-125 Seed Implantation was initiated in July 2005. It is an important issue to limit urinary toxicities in patients who undergo LDR brachytherapy. Copyright © 2015 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.

Implant-supported Oral Rehabilitation in Child with Ectodermal Dysplasia - 4-year Follow-up.

PubMed

Cezária Triches, Thaisa; Ximenes, Marcos; Oliveira de Souza, João Gustavo; Rodrigues Lopes Pereira Neto, Armando; Cardoso, Antônio Carlos; Bolan, Michele

2017-01-01

Ectodermal dysplasia (ED) is an anomaly determined by genetic factors that alter ectodermal structures such as skin, hair, nails, glands, and teeth. Children affected by this condition require extensive, comprehensive, and multidisciplinary treatment. An 8-year-old female patient visited the Dentistry Clinic of the Federal University of Santa Catarina with the chief complaint of multiple missing teeth. The mother reported that the patient had ED. Clinical and radiographic examination revealed the congenital absence of several primary and permanent teeth and tooth germs. Subsequent oral rehabilitation comprised the application of a maxillary denture and mandibular implant-supported fixed prosthesis. The child was also supplied with a wig for further enhancement of esthetics aimed at improving her emotional wellbeing. Psychological follow-up and speech therapy were also provided. After 4 years of follow-up, implant-supported oral rehabilitation has proved to be a satisfactory treatment option, allowing restoration of masticatory, phonetic, and esthetic function, as well as an improvement in the patient's self-esteem and social wellbeing.

Electrical treatment of atrial arrhythmias in heart failure patients implanted with a dual defibrillator CRT device. Results from the TRADE-HF study.

PubMed

Botto, Giovanni Luca; Padeletti, Luigi; Covino, Gregorio; Pieragnoli, Paolo; Liccardo, Mattia; Mariconti, Barbara; Favale, Stefano; Molon, Giulio; De Filippo, Paolo; Bolognese, Leonardo; Landolina, Maurizio; Raciti, Giovanni; Boriani, Giuseppe

2017-06-01

Ventricular and atrial arrhythmias commonly occur in heart failure patients and are a significant source of symptoms, morbidity and mortality. Some specific generators referred to as dual defibrillators, Dual CRT-Ds, have the ability to treat atrial and ventricular arrhythmias. TRADE-HF is a prospective two-arm randomized study aimed at assessing the benefits of complete automatic management of atrial arrhythmias in patients implanted with a dual CRT-D. Primary objective of the TRADE-HF study was to document reduction of unplanned hospital admission for cardiac reasons or death for cardiovascular causes or progression to permanent AF, by comparing fully-automatic device driven therapy for atrial tachycardia or fibrillation (AT/AF) to an in-hospital approach for treatment of symptomatic AT/AF. Randomized Patients were followed every 6months for 3years to assess the primary objective. Four-hundred-twenty patients have been enrolled in the study. At the end of the study 30 subjects died for cardiovascular causes, 60 had at least one hospitalization for cardiovascular causes and 14 developed permanent AF. Eighty-seven patients experienced a composite event. Hazard Ratio for device-managed automatic therapy arm compared to traditional was 0.987 (95% CI: 0.684-1.503; p=0.951). The primary endpoint analysis resulted in no difference between the device managed and in-hospital treatment arm. The TRADE-HF study failed to demonstrate a reduction in the composite of unplanned hospitalizations for cardiovascular causes or death for cardiovascular causes or progression to permanent AF using automatic atrial therapy compared to a traditional approach including hospitalization for symptomatic episodes and/or in-hospital treatment of AT/AF. Copyright © 2017 Elsevier B.V. All rights reserved.

Directly auto-transplanted mesenchymal stem cells induce bone formation in a ceramic bone substitute in an ectopic sheep model

PubMed Central

Boos, Anja M; Loew, Johanna S; Deschler, Gloria; Arkudas, Andreas; Bleiziffer, Oliver; Gulle, Heinz; Dragu, Adrian; Kneser, Ulrich; Horch, Raymund E; Beier, Justus P

2011-01-01

Abstract Bone tissue engineering approaches increasingly focus on the use of mesenchymal stem cells (MSC). In most animal transplantation models MSC are isolated and expanded before auto cell transplantation which might be critical for clinical application in the future. Hence this study compares the potential of directly auto-transplanted versus in vitro expanded MSC with or without bone morphogenetic protein-2 (BMP-2) to induce bone formation in a large volume ceramic bone substitute in the sheep model. MSC were isolated from bone marrow aspirates and directly auto-transplanted or expanded in vitro and characterized using fluorescence activated cell sorting (FACS) and RT-PCR analysis before subcutaneous implantation in combination with BMP-2 and β-tricalcium phosphate/hydroxyapatite (β-TCP/HA) granules. Constructs were explanted after 1 to 12 weeks followed by histological and RT-PCR evaluation. Sheep MSC were CD29+, CD44+ and CD166+ after selection by Ficoll gradient centrifugation, while directly auto-transplanted MSC-populations expressed CD29 and CD166 at lower levels. Both, directly auto-transplanted and expanded MSC, were constantly proliferating and had a decreasing apoptosis over time in vivo. Directly auto-transplanted MSC led to de novo bone formation in a heterotopic sheep model using a β-TCP/HA matrix comparable to the application of 60 μg/ml BMP-2 only or implantation of expanded MSC. Bone matrix proteins were up-regulated in constructs following direct auto-transplantation and in expanded MSC as well as in BMP-2 constructs. Up-regulation was detected using immunohistology methods and RT-PCR. Dense vascularization was demonstrated by CD31 immunohistology staining in all three groups. Ectopic bone could be generated using directly auto-transplanted or expanded MSC with β-TCP/HA granules alone. Hence BMP-2 stimulation might become dispensable in the future, thus providing an attractive, clinically feasible approach to bone tissue engineering. PMID:20636333

A novel orbital tissue expander (OTE): design, in vitro, and in vivo studies

NASA Astrophysics Data System (ADS)

Lee, Elizabete; Tse, David; Pinchuk, Leonard; Acosta, Ana C.; Martin, John B.; Davis, Stewart B.; Hernandez, Eleut; Yamamoto, Hideo; Denham, David B.; Dubovy, Sander; Parel, Jean-Marie

2006-02-01

Purpose: To assess the efficacy of a novel orbital tissue expander (OTE) in treating congenital anophthalmic and microphthalmic infants. Methods: The OTE implant is an inflatable (0.5 to >6cc) silicone rubber globe sliding on a titanium T-shaped bone plate secured to the temporal bone with 1mm titanium screws. In vitro testing was performed to assess injection volume versus diameter measurements to determine consistency between devices, flex fatigue for durability of the implants when compressed, weight change in isotonic saline at 37°C to mimic human body temperature, seal durability by puncturing the globe numerous times while inflating, capacity before rupture to determine the maximum amount of saline it is able to contain, and effective sterilization. Ex-vivo testing was performed for adjustments prior to in vivo study. An OTE was then implanted in five 2-week old kittens (OS only) and inflated in 0.5cc increments. Three control animals received enucleation alone. All 8 animals were followed for 18 weeks and underwent euthanasia for morphological and histopathological analysis. Results: In vitro testing confirmed a <5% diameter variance between different OTEs inflated in 0.5cc increments up to 5.0cc, <5% weight change in isotonic saline at 37°C over 7 weeks, <3% weight change over 14 months in the fatigue tester, and no quantifiable leakage (<1mg) after 65 consecutive 30ga needle punctures. The OTEs were successfully sterilized by autoclave and easily secured in the orbit of postmortem kittens. The in vivo study demonstrated biocompatibility of the implant which stimulates orbital bone growth resulting in almost no difference between the implanted socket and the control eye of the cat. There were no adverse effects in the normal maturation, weight gain, and food intake of the cats. Light microscopy showed no signs of foreign body reaction. Pictures of the implants were obtained by using a shadow-photogrammetry system to compare the explanted OTE with the OD control eye. Conclusion: In vitro and in vivo studies show the implant's potential to safely treat anophthalmic and microphthalmic infants.

Shaped versus Round Implants in Breast Reconstruction: A Multi-Institutional Comparison of Surgical and Patient-Reported Outcomes.

PubMed

Khavanin, Nima; Clemens, Mark W; Pusic, Andrea L; Fine, Neil A; Hamill, Jennifer B; Kim, H Myra; Qi, Ji; Wilkins, Edwin G; Kim, John Y S

2017-05-01

Since the 2012 approval of shaped implants, their use in breast reconstruction has increased in the United States. However, large-scale comparisons of complications and patient-reported outcomes are lacking. The authors endeavored to compare surgical and patient-reported outcomes across implant types. The Mastectomy Reconstruction Outcomes Consortium database was queried for expander/implant reconstructions with at least 1-year postexchange follow-up (mean, 18.5 months). Outcomes of interest included postoperative complications, 1-year revisions, and patient-reported outcomes. Bivariate and mixed-effects regression analyses evaluated the effect of implant type on patient outcomes. Overall, 822 patients (73.5 percent) received round and 297 patients (26.5 percent) received shaped implants. Patients undergoing unilateral reconstructions with round implants underwent more contralateral symmetry procedures, including augmentations (round, 18.7 percent; shaped, 6.8 percent; p = 0.003) and reductions (round, 32.2 percent; shaped, 20.5 percent; p = 0.019). Shaped implants were associated with higher rates of infection (shaped, 6.1 percent; round, 2.3 percent; p = 0.002), that remained significant after multivariable adjustment. Other complication rates did not differ significantly between cohorts. Round and shaped implants experienced similar 2-year patient-reported outcome scores. This prospective, multicenter study is the largest evaluating outcomes of shaped versus round implants in breast reconstruction. Although recipients of round implants demonstrated lower infection rates compared with shaped implants, these patients were more likely to undergo contralateral symmetry procedures. Both implant types yielded comparable patient-reported outcome scores. With appropriate patient selection, both shaped and round implants can provide acceptable outcomes in breast reconstruction. Therapeutic, III.

Replacing a failed mini-implant with a miniplate to prevent interruption during orthodontic treatment.

PubMed

Lee, Jin-Hwa; Choo, Hyeran; Kim, Seong-Hun; Chung, Kyu-Rhim; Giannuzzi, Lucille A; Ngan, Peter

2011-06-01

When mini-implants fail during orthodontic treatment, there is a need to have a backup plan to either replace the failed implant in the adjacent interradicular area or wait for the bone to heal before replacing the mini-implant. We propose a novel way to overcome this problem by replacement with a miniplate so as not to interrupt treatment or prolong treatment time. The indications, advantages, efficacy, and procedures for switching from a mini-implant to a miniplate are discussed. Two patients who required replacement of failed mini-implants are presented. In the first patient, because of the proximity of the buccal vestibule to the mini-implant, it was decided to replace the failed mini-implant by an I-shaped C-tube miniplate. In the second patient, radiolucencies were found around the failed mini-implants, making the adjacent alveolar bone unavailable for immediate placement of another mini-implant. In addition, the maxillary sinus pneumatization was expanded deeply into the interradicular spaces; this further mandated an alternative placement site. One failed mini-implant was examined under a scanning electron microscope for bone attachment. Treatment was completed in both patients after replacement with miniplates without interrupting the treatment mechanics or prolonging the treatments. Examination under the scanning electron microscope showed partial bone growth into the coating pores and titanium substrate interface even after thorough cleaning and sterilization. Replacement with a miniplate is a viable solution for failed mini-implants during orthodontic treatment. The results from microscopic evaluation of the failed mini-implant suggest that stringent guidelines are needed for recycling used mini-implants. Copyright © 2011 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

The Italian subcutaneous implantable cardioverter-defibrillator survey: S-ICD, why not?

PubMed

Botto, Giovanni Luca; Forleo, Giovanni B; Capucci, Alessandro; Solimene, Francesco; Vado, Antonello; Bertero, Giovanni; Palmisano, Pietro; Pisanò, Ennio; Rapacciuolo, Antonio; Infusino, Tommaso; Vicentini, Alessandro; Viscusi, Miguel; Ferrari, Paola; Talarico, Antonello; Russo, Giovanni; Boriani, Giuseppe; Padeletti, Luigi; Lovecchio, Mariolina; Valsecchi, Sergio; D'Onofrio, Antonio

2017-11-01

A recommendation for a subcutaneous-implantable cardioverter-defibrillator (S-ICD) has been added to recent European Society of Cardiology Guidelines. However, the S-ICD is not ideally suitable for patients who need pacing. The aim of this survey was to analyse the current practice of ICD implantation and to evaluate the actual suitability of S-ICD. The survey 'S-ICD Why Not?' was an independent initiative taken by the Italian Heart Rhythm Society (AIAC). Clinical characteristics, selection criteria, and factors guiding the choice of ICD type were collected in consecutive patients who underwent ICD implantation in 33 Italian centres from September to December 2015. A cardiac resynchronization therapy (CRT) device was implanted in 39% (369 of 947) of patients undergoing de novo ICD implantation. An S-ICD was implanted in 12% of patients with no CRT indication (62 of 510 with available data). S-ICD patients were younger than patients who received transvenous ICD, more often had channelopathies, and more frequently received their device for secondary prevention of sudden death. More frequently, the clinical reason for preferring a transvenous ICD over an S-ICD was the need for pacing (45%) or for antitachycardia pacing (36%). Nonetheless, only 7% of patients fulfilled conditions for recommending permanent pacing, and 4% of patients had a history of monomorphic ventricular tachycardia that might have been treatable with antitachycardia pacing. The vast majority of patients needing ICD therapy are suitable candidates for S-ICD implantation. Nevertheless, it currently seems to be preferentially adopted for secondary prevention of sudden death in young patients with channelopathies. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

Reversible Femtosecond Laser-Assisted Myopia Correction: A Non-Human Primate Study of Lenticule Re-Implantation after Refractive Lenticule Extraction

PubMed Central

Chaurasia, Shyam S.; Lee, Wing S.; Tan, Donald T.; Mehta, Jodhbir S.

2013-01-01

LASIK (laser-assisted in situ keratomileusis) is a common laser refractive procedure for myopia and astigmatism, involving permanent removal of anterior corneal stromal tissue by excimer ablation beneath a hinged flap. Correction of refractive error is achieved by the resulting change in the curvature of the cornea and is limited by central corneal thickness, as a thin residual stromal bed may result in biomechanical instability of the cornea. A recently developed alternative to LASIK called Refractive Lenticule Extraction (ReLEx) utilizes solely a femtosecond laser (FSL) to incise an intrastromal refractive lenticule (RL), which results in reshaping the corneal curvature and correcting the myopia and/or astigmatism. As the RL is extracted intact in the ReLEx, we hypothesized that it could be cryopreserved and re-implanted at a later date to restore corneal stromal volume, in the event of keratectasia, making ReLEx a potentially reversible procedure, unlike LASIK. In this study, we re-implanted cryopreserved RLs in a non-human primate model of ReLEx. Mild intrastromal haze, noted during the first 2 weeks after re-implantation, subsided after 8 weeks. Refractive parameters including corneal thickness, anterior curvature and refractive error indices were restored to near pre-operative values after the re-implantation. Immunohistochemistry revealed no myofibroblast formation or abnormal collagen type I expression after 8 weeks, and a significant attenuation of fibronectin and tenascin expression from week 8 to 16 after re-implantation. In addition, keratocyte re-population could be found along the implanted RL interfaces. Our findings suggest that RL cryopreservation and re-implantation after ReLEx appears feasible, suggesting the possibility of potential reversibility of the procedure, and possible future uses of RLs in treating other corneal disorders and refractive errors. PMID:23826194

An approach to ablate and pace:AV junction ablation and pacemaker implantation performed concurrently from the same venous access site.

PubMed

Issa, Ziad F

2007-09-01

Atrioventricular junction (AVJ) ablation combined with permanent pacemaker implantation (the "ablate and pace" approach) remains an acceptable alternative treatment strategy for symptomatic, drug-refractory atrial fibrillation (AF) with rapid ventricular response. This case series describes the feasibility and safety of catheter ablation of the AVJ via a superior vena caval approach performed during concurrent dual-chamber pacemaker implantation. A total of 17 consecutive patients with symptomatic, drug-refractory, paroxysmal AF underwent combined AVJ ablation and dual-chamber pacemaker implantation procedure using a left axillary venous approach. Two separate introducer sheaths were placed into the axillary vein. The first sheath was used for implantation of the pacemaker ventricular lead, which was then connected to the pulse generator. Subsequently, a standard ablation catheter was introduced through the second axillary venous sheath and used for radiofrequency (RF) ablation of the AVJ. After successful ablation, the catheter was withdrawn and the pacemaker atrial lead was advanced through that same sheath and implanted in the right atrium. Catheter ablation of the AVJ was successfully achieved in all patients. The median number of RF applications required to achieve complete AV block was three (range 1-10). In one patient, AV conduction recovered within the first hour after completion of the procedure, and AVJ ablation was then performed using the conventional femoral venous approach. There were no procedural complications. Catheter ablation of the AVJ can be performed successfully and safely via a superior vena caval approach in patients undergoing concurrent dual-chamber pacemaker implantation.

Determining the risks of clinically indicated nonthoracic magnetic resonance imaging at 1.5 T for patients with pacemakers and implantable cardioverter-defibrillators: rationale and design of the MagnaSafe Registry.

PubMed

Russo, Robert J

2013-03-01

Until recently, the presence of a permanent pacemaker or an implantable cardioverter-defibrillator has been a relative contraindication for the performance of magnetic resonance imaging (MRI). A number of small studies have shown that MRI can be performed with minimal risk when patients are properly monitored and device programming is modified appropriately for the procedure. However, the risk of performing MRI for patients with implanted cardiac devices has not been sufficiently evaluated to advocate routine clinical use. The aim of the present protocol is to prospectively determine the rate of adverse clinical events and device parameter changes in patients with implanted non-MRI-conditional cardiac devices undergoing clinically indicated nonthoracic MRI at 1.5 T. The MagnaSafe Registry is a multicenter, prospective cohort study of up to 1500 MRI examinations in patients with pacemakers or implantable cardioverter-defibrillators implanted after 2001 who undergo clinically indicated nonthoracic MRI following a specific protocol to ensure that preventable potential adverse events are mitigated. Adverse events and changes in device parameter measurements that may be associated with the imaging procedure will be documented. Through August 2012, 701 MRI studies have been performed, representing 47% of the total target enrollment. The results of this registry will provide additional documentation of the risk of MRI and will further validate a clinical protocol for screening and the performance of clinically indicated MRI for patients with implanted cardiac devices. Copyright © 2013 Mosby, Inc. All rights reserved.

The Overall Survival, Complication-Free Survival, and Related Complications of Combined Tooth-Implant Fixed Partial Dentures: A Literature Review

PubMed Central

Borg, Peter; Puryer, James; McNally, Lisa; O’Sullivan, Dominic

2016-01-01

This paper reviews the literature regarding possible complications, complication-free survival, and overall survival of fixed dental prostheses that use both implants and natural teeth as abutments. The paper also provides clinical guidelines for treatment based on this literature review. An electronic search utilizing the MEDLINE, BIOSIS Citation Index, and Web of Science™ Core Collection databases was undertaken, and a review of the 25 selected texts studying 22 different patient cohorts was carried out. From a total of 1610 implants reviewed, 40 were lost (33 due to loss of integration and 7 due to fracture), whereas, out of a total of 1301 teeth, 38 were lost, of which 16 were due to fracture. Seventy-three cases of tooth intrusion were detected. From a total of 676 frameworks reviewed (metal n = 645, Zirconia n = 31), 7 fractured, while veneer material fracture occurred in 70 out of 672 bridges. Overall, 502 out of 531 tooth-implant fixed prostheses (TIPFs) remained functional, and 336 out of 439 prostheses showed no technical or biological complications and remained functional. Rigid TIFPs permanently cemented to teeth with sufficient coronal structure and with limited use of prosthetic attachments offer a good long-term treatment option to patients with good oral hygiene following sound implant placement. This mode of treatment should be used when free-standing implant-supported options may not be possible. Larger randomized control studies and other clinical studies comparing tooth-to-implant-connected treatment with other forms of treatment are needed to better understand the place of TIFP treatment in oral rehabilitation. PMID:29563458

Neuroprostheses to treat neurogenic bladder dysfunction: current status and future perspectives.

PubMed

Rijkhoff, Nico J M

2004-02-01

Neural prostheses are a technology that uses electrical activation of the nervous system to restore function to individuals with neurological or sensory impairment. This article provides an introduction to neural prostheses and lists the most successful neural prostheses (in terms of implanted devices). The article then focuses on neurogenic bladder dysfunction and describes two clinically available implantable neural prostheses for treatment of neurogenic bladder dysfunction. Special attention is given to the usage of these neural prostheses in children. Finally, three new developments that may lead to a new generation of implantable neural prostheses for bladder control are described. They may improve the neural prostheses currently available and expand further the population of patients who can benefit from a neural prosthesis.

Impact of polymer structure and composition on fully resorbable endovascular scaffold performance

PubMed Central

Ferdous, Jahid; Kolachalama, Vijaya B.; Shazly, Tarek

2014-01-01

Fully erodible endovascular scaffolds are being increasingly considered for the treatment of obstructive arterial disease owing to their potential to mitigate long-term risks associated with permanent alternatives. While complete scaffold erosion facilitates vessel healing, generation and release of material degradation by-products from candidate materials such as poly-l-lactide (PLLA) may elicit local inflammatory responses that limit implant efficacy. We developed a computational framework to quantify how the compositional and structural parameters of PLLA-based fully erodible endovascular scaffolds affect degradation kinetics, erosion kinetics and the transient accumulation of material by-products within the arterial wall. Parametric studies reveal that, while some material properties have similar effects on these critical processes, others induce qualitatively opposing responses. For example, scaffold degradation is only mildly responsive to changes in either PLLA polydispersity or the initial degree of crystallinity, while the erosion kinetics is comparatively sensitive to crystallinity. Moreover, lactide doping can effectively tune both scaffold degradation and erosion, but a concomitant increase in local byproduct accumulation raises concerns about implant safety. Optimized erodible endovascular scaffolds must precisely balance therapeutic function and biological response over the implant lifetime, where compositional and structural parameters will have differential effects on implant performance. PMID:23261926

Use of SIG device to accurately place permanent miniature dental implants to retain mandibular overdenture. A case report.

PubMed

Sussman, Harold I; Goodridge, Opal F

2006-01-01

A case of mini-dental implant insertion for retention of a mandibular overdenture in a hospitalized patient has been documented. The additional use of the SIG (drill guide) directional device in the implant placement protocol gave the practitioner more confidence and resulted in the proper alignment of the three ball-top, one-piece fixtures. The three implants were inserted exactly 1 cm apart and parallel to each other. The distal fixtures were approximately 1 cm away from the mental foramina, thereby eliminating the risk of lip paresthesia. Keeper caps were placed in the denture's intaglio after one month. The keeper caps allowed for proper retention of the overdenture. The caps also enabled the patient to easily insert and withdraw his denture, even though he displayed limited manual dexterity. The tissue response was excellent, and oral hygiene was made easier with adequate spacing of the exposed ball-tops. The overall experience for both the operator and the patient was very positive. General dentists should be able to readily master this technique and add it to their armamentarium for the benefit of all their patients.

Endometrial fluid associated with Essure implants placed before in vitro fertilization: Considerations for patient counseling and surgical management

PubMed Central

Walsh, David J; Jones, Christopher A; Wood, Samuel H

2015-01-01

Essure (Bayer) received approval from the U.S. Food and Drugs Administration as a permanent non-hormonal contraceptive implant in November 2002. While the use of Essure in the management of hydrosalpinx prior to in vitro fertilization (IVF) remains off-label, it has been used specifically for this purpose since at least 2007. Although most published reports on Essure placement before IVF have been reassuring, clinical experience remains limited, and no randomized studies have demonstrated the safety or efficacy of Essure in this context. In fact, no published guidelines deal with patient selection or counseling regarding the Essure procedure specifically in the context of IVF. Although Essure is an irreversible birth control option, some patients request the surgical removal of the implants for various reasons. While these patients could eventually undergo hysterectomy, at present no standardized technique exists for simple Essure removal with conservation of the uterus. This article emphasizes new aspects of the Essure procedure, as we describe the first known association between the placement of Essure implants and the subsequent development of fluid within the uterine cavity, which resolved after the surgical removal of both devices. PMID:26473113

Polymeric endovascular strut and lumen detection algorithm for intracoronary optical coherence tomography images

NASA Astrophysics Data System (ADS)

Amrute, Junedh M.; Athanasiou, Lambros S.; Rikhtegar, Farhad; de la Torre Hernández, José M.; Camarero, Tamara García; Edelman, Elazer R.

2018-03-01

Polymeric endovascular implants are the next step in minimally invasive vascular interventions. As an alternative to traditional metallic drug-eluting stents, these often-erodible scaffolds present opportunities and challenges for patients and clinicians. Theoretically, as they resorb and are absorbed over time, they obviate the long-term complications of permanent implants, but in the short-term visualization and therefore positioning is problematic. Polymeric scaffolds can only be fully imaged using optical coherence tomography (OCT) imaging-they are relatively invisible via angiography-and segmentation of polymeric struts in OCT images is performed manually, a laborious and intractable procedure for large datasets. Traditional lumen detection methods using implant struts as boundary limits fail in images with polymeric implants. Therefore, it is necessary to develop an automated method to detect polymeric struts and luminal borders in OCT images; we present such a fully automated algorithm. Accuracy was validated using expert annotations on 1140 OCT images with a positive predictive value of 0.93 for strut detection and an R2 correlation coefficient of 0.94 between detected and expert-annotated lumen areas. The proposed algorithm allows for rapid, accurate, and automated detection of polymeric struts and the luminal border in OCT images.

Low elastic modulus Ti-Ta alloys for load-bearing permanent implants: enhancing the biodegradation resistance by electrochemical surface engineering.

PubMed

Kesteven, Jazmin; Kannan, M Bobby; Walter, Rhys; Khakbaz, Hadis; Choe, Han-Choel

2015-01-01

In this study, the in vitro degradation behaviour of titanium-tantalum (Ti-Ta) alloys (10-30 wt.% Ta) was investigated and compared with conventional implant materials, i.e., commercially pure titanium (Cp-Ti) and titanium-aluminium-vanadium (Ti6Al4V) alloy. Among the three Ti-Ta alloys studied, the Ti20Ta (6.3×10(-4) mm/y) exhibited the lowest degradation rate, followed by Ti30Ta (1.2×10(-3) mm/y) and Ti10Ta (1.4×10(-3) mm/y). All the Ti-Ta alloys exhibited lower degradation rate than that of Cp-Ti (1.8×10(-3) mm/y), which suggests that Ta addition to Ti is beneficial. As compared to Ti6Al4V alloy (8.1×10(-4) mm/y), the degradation rate of Ti20Ta alloy was lower by ~22%. However, the Ti30Ta alloy, which has closer elastic modulus to that of natural bone, showed ~48% higher degradation rate than that of Ti6Al4V alloy. Hence, to improve the degradation performance of Ti30Ta alloy, an intermediate thin porous layer was formed electrochemically on the alloy followed by calcium phosphate (CaP) electrodeposition. The coated Ti30Ta alloy (3.8×10(-3) mm/y) showed ~53% lower degradation rate than that of Ti6Al4V alloy. Thus, the study suggests that CaP coated Ti30Ta alloy can be a viable material for load-bearing permanent implants. Copyright © 2014 Elsevier B.V. All rights reserved.

Complications of pacemaker therapy in adults with congenital heart disease: a multicenter study.

PubMed

Opić, Petra; van Kranenburg, Matthijs; Yap, Sing-Chien; van Dijk, Arie P; Budts, Werner; Vliegen, Hubert W; van Erven, Lieselot; Can, Anil; Sahin, Gulhan; Theuns, Dominic A M J; Witsenburg, Maarten; Roos-Hesselink, Jolien W

2013-10-09

This study aims to investigate indications and complications of permanent cardiac pacing in adults with congenital heart disease (CHD). Two-hundred and seventy-four CHD patients were identified who underwent permanent pacemaker implantation between 1972 and 2009. The indication for pacing was acquired sinus node or AV node conduction disease (63%), sinus node or AV node conduction disease after cardiac surgery (28%), and drug/arrhythmia-related indications (9%). Patients with complex CHD received a pacemaker at younger age (23 versus 31 years, p<0.0001) and more often received an epicardial pacing system (51% versus 23%, p<0.0001) compared to those with simple or moderate CHD. Twenty-nine patients (10.6%) had a periprocedural complication during the primary pacemaker implantation (general population: 5.2%). The most common acute complications were lead dysfunction (4.0%), bleeding (2.6%), pocket infection (1.5%) and pneumothorax (1.5%). During a median follow-up of 12 years, pacemaker-related complications requiring intervention occurred in 95 patients (34.6%). The most common late pacemaker-related complications included lead failure (24.8%), pacemaker dysfunction/early battery depletion (5.1%), pacemaker migration (4.7%) and erosion (4.7%). Pacemaker implantation at younger age (<18 years) was an independent predictor of late pacemaker-related complication (adjusted hazard ratio 1.68, 95% confidence interval 1.07 to 2.63, p=0.023). The risk of periprocedural complications seems higher in the CHD population compared to the general population and more than one-third of CHD patients encountered a pacemaker-related complication during long-term follow-up. This risk increases for those who receive a pacemaker at younger age. Crown Copyright © 2013. Published by Elsevier Ireland Ltd. All rights reserved.

Long-term outcome in patients receiving permanent pacemaker implantation for atrioventricular block: Comparison of VDD and DDD pacing.

PubMed

Liao, Jo-Nan; Chao, Tze-Fan; Tuan, Ta-Chuan; Kong, Chi-Woon; Chen, Shih-Ann

2016-08-01

A permanent pacemaker (PPM) with dual chamber pacing (DDD) offers atrioventricular synchronization for patients with atrioventricular block (AVB). Single lead atrial synchronous ventricular pacing mode (VDD) is an alternative, but there are concerns about its efficacy and risk of atrial undersensing. Whether VDD can be a good alternative in patients with AVB remains unknown. The aim of the present study was to compare the long-term risk of mortality of VDD with DDD pacing.A total of 207 patients undergoing PPM implantations for AVB with VDD mode were enrolled from 2000 to 2013. Another 828 age- and sex-matched patients undergoing DDD implantations during the same period of time were selected as the control group in a 1 to 4 ratio. The study endpoint was mortality.A total of 1035 patients (64.3% male) were followed up for 46.5 ± 43.2 months. The mean ages were 75.0 years for VDD, and 74.9 years for DDD. The Kaplan-Meier survival analysis showed no significant difference in long-term survival between the VDD and DDD groups (log-rank P = 0.313). After adjustment for baseline characteristics, the VDD and DDD groups had a similar long-term prognosis with an adjusted hazard ratio of 0.875 (P = 0.445). Further analyses for the risk of cardiovascular and noncardiovascular deaths also showed no significant differences between the 2 groups.The long-term prognosis of VDD mode is comparable to that of DDD mode. Single lead VDD can be considered as an alternative choice in patients with AVB without sinus nodal dysfunction.

Long-term outcome in patients receiving permanent pacemaker implantation for atrioventricular block

PubMed Central

Liao, Jo-Nan; Chao, Tze-Fan; Tuan, Ta-Chuan; Kong, Chi-Woon; Chen, Shih-Ann

2016-01-01

Abstract A permanent pacemaker (PPM) with dual chamber pacing (DDD) offers atrioventricular synchronization for patients with atrioventricular block (AVB). Single lead atrial synchronous ventricular pacing mode (VDD) is an alternative, but there are concerns about its efficacy and risk of atrial undersensing. Whether VDD can be a good alternative in patients with AVB remains unknown. The aim of the present study was to compare the long-term risk of mortality of VDD with DDD pacing. A total of 207 patients undergoing PPM implantations for AVB with VDD mode were enrolled from 2000 to 2013. Another 828 age- and sex-matched patients undergoing DDD implantations during the same period of time were selected as the control group in a 1 to 4 ratio. The study endpoint was mortality. A total of 1035 patients (64.3% male) were followed up for 46.5 ± 43.2 months. The mean ages were 75.0 years for VDD, and 74.9 years for DDD. The Kaplan–Meier survival analysis showed no significant difference in long-term survival between the VDD and DDD groups (log-rank P = 0.313). After adjustment for baseline characteristics, the VDD and DDD groups had a similar long-term prognosis with an adjusted hazard ratio of 0.875 (P = 0.445). Further analyses for the risk of cardiovascular and noncardiovascular deaths also showed no significant differences between the 2 groups. The long-term prognosis of VDD mode is comparable to that of DDD mode. Single lead VDD can be considered as an alternative choice in patients with AVB without sinus nodal dysfunction. PMID:27583889

Midterm Follow-Up of the Stentless Freedom Solo Bioprosthesis in 350 Patients.

PubMed

Wollersheim, Laurens W; Li, Wilson W; Bouma, Berto J; Kaya, Abdullah; van Boven, Wim J; van der Meulen, Jan; de Mol, Bas A

2016-07-01

The stentless Freedom Solo aortic bioprosthesis is implanted supraannularly using one running suture line in the sinuses of Valsalva. We report our 9-year experience with this bioprosthesis. From April 2005 to July 2014, 350 consecutive patients at our institution underwent aortic valve replacement with the Freedom Solo bioprosthesis. Follow-up and echocardiographic data were collected retrospectively from referring cardiology centers. The mean age was 76 ± 6 years, 48% were male, and 46% underwent a concomitant procedure. Median EuroSCORE II was 3.0 (interquartile range, 1.9 to 4.9). Operative mortality was 5.1% for all procedures and 2.1% for isolated aortic valve replacement. The 1-, 5-, and 9-year overall survival was 92%, 74%, and 47%, respectively. At 6 years, freedom from structural valve deterioration and freedom from aortic valve reoperation were 98% and 96%, respectively. Prosthetic valve endocarditis occurred at a rate of 0.8% per patient-year. Permanent pacemaker implantation was necessary in 2.3% (n = 8), and moderate and severe prosthesis-patient mismatch occurred in 30 patients overall (9.6%). Postoperative maximum and mean valvular gradients were 17 mm Hg and 10 mm Hg, respectively, and remained stable during follow-up. Aortic valve replacement with the Freedom Solo is safe and has a low rate of permanent pacemaker implantations and prosthesis-patient mismatch. Survival is comparable to that with other aortic bioprostheses, and structural valve deterioration and aortic valve reoperation are infrequent during midterm follow-up. Hemodynamic performance is excellent, with low valvular gradients that remain stable during follow-up. Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

The JUPITER registry: One-year outcomes of transapical aortic valve implantation using a second generation transcatheter heart valve for aortic regurgitation.

PubMed

Silaschi, Miriam; Conradi, Lenard; Wendler, Olaf; Schlingloff, Friederike; Kappert, Utz; Rastan, Ardawan J; Baumbach, Hardy; Holzhey, David; Eichinger, Walter; Bader, Ralf; Treede, Hendrik

2018-06-01

We present 1-year outcomes of the post-market registry of a next-generation transcatheter heart valve used for aortic regurgitation (AR). Transcatheter aortic valve replacement (TAVR) is routine in high-risk patients with aortic stenosis but is not recommended for AR. The JenaValve™ (JenaValve Technology GmbH, Munich, Germany) overcomes technical challenges in AR patients through a leaflet clipping mechanism. The JenaValve EvalUation of Long Term Performance and Safety In PaTients with SEvere Aortic Stenosis oR Aortic Insufficiency (JUPITER) Registry is a European study to evaluate safety and effectiveness of this THV. From 2012-2015, 30 patients with AR were enrolled. Mean age was 74.4 ± 9.3 years. Procedural success was 96.7% (29/30). One patient was converted to open surgery. No annular rupture or coronary ostia obstruction occurred. Mortality at 30 days was 10.0% (3/30). Combined safety endpoint was met in 13.3% (4/30). Paravalvular regurgitation was not present/trivial in 84.6% (22/26) and mild in 15.4% (4/26). Rate of permanent pacemaker implantation was 3.8% (1/26). One-year Kaplan-Meier survival was 79.9%, one-year combined efficacy was 73.1% (19/30). No further strokes were observed during 1 year of follow-up. The JenaValve overcomes technical challenges of TAVR in AR through a clipping mechanism. We report satisfactory outcomes of a multicenter registry using the JenaValve for predominant AR, as rate of THV embolization, residual AR and permanent pacemaker implantation was low. One-year results using the JenaValve for AR encourage its use for this indication. © 2017 Wiley Periodicals, Inc.

Interventional Cardiology: What's New?

PubMed

Scansen, Brian A

2017-09-01

Interventional cardiology in veterinary medicine continues to expand beyond the standard 3 procedures of patent ductus arteriosus occlusion, balloon pulmonary valvuloplasty, and transvenous pacing. Opportunities for fellowship training; advances in equipment, including high-resolution digital fluoroscopy, real-time 3-dimensional transesophageal echocardiography, fusion imaging, and rotational angiography; ultrasound-guided access and vascular closure devices; and refinement of techniques, including cutting and high-pressure ballooning, intracardiac and intravascular stent implantation, septal defect occlusion, transcatheter valve implantation, and hybrid approaches, are likely to transform the field over the next decade. Copyright © 2017 Elsevier Inc. All rights reserved.

Shape memory polymers

DOEpatents

Wilson, Thomas S.; Bearinger, Jane P.

2017-08-29

New shape memory polymer compositions, methods for synthesizing new shape memory polymers, and apparatus comprising an actuator and a shape memory polymer wherein the shape memory polymer comprises at least a portion of the actuator. A shape memory polymer comprising a polymer composition which physically forms a network structure wherein the polymer composition has shape-memory behavior and can be formed into a permanent primary shape, re-formed into a stable secondary shape, and controllably actuated to recover the permanent primary shape. Polymers have optimal aliphatic network structures due to minimization of dangling chains by using monomers that are symmetrical and that have matching amine and hydroxl groups providing polymers and polymer foams with clarity, tight (narrow temperature range) single transitions, and high shape recovery and recovery force that are especially useful for implanting in the human body.

Shape memory polymers

DOEpatents

Wilson, Thomas S.; Bearinger, Jane P.

2015-06-09

New shape memory polymer compositions, methods for synthesizing new shape memory polymers, and apparatus comprising an actuator and a shape memory polymer wherein the shape memory polymer comprises at least a portion of the actuator. A shape memory polymer comprising a polymer composition which physically forms a network structure wherein the polymer composition has shape-memory behavior and can be formed into a permanent primary shape, re-formed into a stable secondary shape, and controllably actuated to recover the permanent primary shape. Polymers have optimal aliphatic network structures due to minimization of dangling chains by using monomers that are symmetrical and that have matching amine and hydroxyl groups providing polymers and polymer foams with clarity, tight (narrow temperature range) single transitions, and high shape recovery and recovery force that are especially useful for implanting in the human body.

Comparison of self-expandable and balloon-expanding stents for hybrid ductal stenting in hypoplastic left heart complex.

PubMed

Goreczny, Sebastian; Qureshi, Shakeel A; Rosenthal, Eric; Krasemann, Thomas; Nassar, Mohamed S; Anderson, David R; Morgan, Gareth J

2017-07-01

We aimed to compare the procedural and mid-term performance of a specifically designed self-expanding stent with balloon-expandable stents in patients undergoing hybrid palliation for hypoplastic left heart syndrome and its variants. The lack of specifically designed stents has led to off-label use of coronary, biliary, or peripheral stents in the neonatal ductus arteriosus. Recently, a self-expanding stent, specifically designed for use in hypoplastic left heart syndrome, has become available. We carried out a retrospective cohort comparison of 69 neonates who underwent hybrid ductal stenting with balloon-expandable and self-expanding stents from December, 2005 to July, 2014. In total, 43 balloon-expandable stents were implanted in 41 neonates and more recently 47 self-expanding stents in 28 neonates. In the balloon-expandable stents group, stent-related complications occurred in nine patients (22%), compared with one patient in the self-expanding stent group (4%). During follow-up, percutaneous re-intervention related to the ductal stent was performed in five patients (17%) in the balloon-expandable stent group and seven patients (28%) in self-expanding stents group. Hybrid ductal stenting with self-expanding stents produced favourable results when compared with the results obtained with balloon-expandable stents. Immediate additional interventions and follow-up re-interventions were similar in both groups with complications more common in those with balloon-expandable stents.

Evaluation of Sidestream Darkfield Microscopy for Real-Time Imaging Acellular Dermal Matrix Revascularization.

PubMed

DeGeorge, Brent R; Olenczak, J Bryce; Cottler, Patrick S; Drake, David B; Lin, Kant Y; Morgan, Raymond F; Campbell, Christopher A

2016-06-01

Acellular dermal matrices (ADMs) serve as a regenerative framework for host cell integration and collagen deposition to augment the soft tissue envelope in ADM-assisted breast reconstruction-a process dependent on vascular ingrowth. To date noninvasive intra-operative imaging techniques have been inadequate to evaluate the revascularization of ADM. We investigated the safety, feasibility, and efficacy of sidestream darkfield (SDF) microscopy to assess the status of ADM microvascular architecture in 8 patients at the time of tissue expander to permanent implant exchange during 2-stage ADM-assisted breast reconstruction. The SDF microscopy is a handheld device, which can be used intraoperatively for the real-time assessment of ADM blood flow, vessel density, vessel size, and branching pattern. The SDF microscopy was used to assess the microvascular architecture in the center and border zone of the ADM and to compare the native, non-ADM-associated capsule in each patient as a within-subject control. No incidences of periprosthetic infection, explantation, or adverse events were reported after SDF image acquisition. Native capsules demonstrate a complex, layered architecture with an average vessel area density of 14.9 mm/mm and total vessel length density of 12.3 mm/mm. In contrast to native periprosthetic capsules, ADM-associated capsules are not uniformly vascularized structures and demonstrate 2 zones of microvascular architecture. The ADM and native capsule border zone demonstrates palisading peripheral vascular arcades with continuous antegrade flow. The central zone of the ADM demonstrates punctate perforating vascular plexi with intermittent, sluggish flow, and intervening 2- to 3-cm watershed zones. Sidestream darkfield microscopy allows for real-time intraoperative assessment of ADM revascularization and serves as a potential methodology to compare revascularization parameters among commercially available ADMs. Thr SDF microscopy demonstrates that the periprosthetic capsule in ADM-assisted implant-based breast reconstruction is not a uniformly vascularized structure.

Directional interstitial brachytherapy from simulation to application

NASA Astrophysics Data System (ADS)

Lin, Liyong

Organs at risk (OAR) are sometimes adjacent to or embedded in or overlap with the clinical target volume (CTV) to be treated. The purpose of this PhD study is to develop directionally low energy gamma-emitting interstitial brachytherapy sources. These sources can be applied between OAR to selectively reduce hot spots in the OARs and normal tissues. The reduction of dose over undesired regions can expand patient eligibility or reduce toxicities for the treatment by conventional interstitial brachytherapy. This study covers the development of a directional source from design optimization to construction of the first prototype source. The Monte Carlo code MCNP was used to simulate the radiation transport for the designs of directional sources. We have made a special construction kit to assemble radioactive and gold-shield components precisely into D-shaped titanium containers of the first directional source. Directional sources have a similar dose distribution as conventional sources on the treated side but greatly reduced dose on the shielded side, with a sharp dose gradient between them. A three-dimensional dose deposition kernel for the 125I directional source has been calculated. Treatment plans can use both directional and conventional 125I sources at the same source strength for low-dose-rate (LDR) implants to optimize the dose distributions. For prostate tumors, directional 125I LDR brachytherapy can potentially reduce genitourinary and gastrointestinal toxicities and improve potency preservation for low risk patients. The combination of better dose distribution of directional implants and better therapeutic ratio between tumor response and late reactions enables a novel temporary LDR treatment, as opposed to permanent or high-dose-rate (HDR) brachytherapy for the intermediate risk T2b and high risk T2c tumors. Supplemental external-beam treatments can be shortened with a better brachytherapy boost for T3 tumors. In conclusion, we have successfully finished the design optimization and construction of the first prototype directional source. Potential clinical applications and potential benefits of directional sources have been shown for prostate and breast tumors.

Transcatheter aortic valve implantation using the ACURATE TA™ system: 1-year outcomes and comparison of 500 patients from the SAVI registries.

PubMed

Börgermann, Jochen; Holzhey, David M; Thielmann, Matthias; Girdauskas, Evaldas; Schroefel, Holger; Hofmann, Steffen; Treede, Hendrik; Matschke, Klaus; Hilker, Michael; Strauch, Justus T; Carrel, Thierry; Wahlers, Thorsten; Diegeler, Anno; Kempfert, Jörg; Walther, Thomas

2017-05-01

The ACURATE TA TM system is a self-expanding transcatheter heart valve system designed for transapical access which has been proven to be safe and effective in the controlled setting of clinical trials. The SAVI-1 and SAVI-2 registries aimed to assess whether these promising outcomes can be translated into all-comers clinical routine. From November 2011 to 2012 (SAVI-1), and November 2013 to 2014 (SAVI-2), a total of 500 patients were enrolled in the prospective, all-comers, multicentre, multinational SAVI registries. Patients were treated according to the standard of care at their respective hospitals. We report and compare 30-day and 1-year clinical outcomes between SAVI-1 and -2. Patients were 80.8 ± 6.1 years old, the mean logistic EuroSCORE-I was 23.4 ± 14.3%. Valves were deployed under rapid pacing in 71.3% of the procedures in SAVI-1, and in 3.6% in SAVI-2. There was no relevant difference in clinical and echocardiographic outcomes between SAVI-1 and SAVI-2. Overall mortality at 30 days and 1 year was 6.8% and 19.9%, the stroke rate was 2.2% and 3.7%, respectively; 10.2% of patients had received a permanent pacemaker, and no transcatheter valve-related complications after discharge were observed. Paravalvular leakage ≥2+ was reported in 1.9% of the patients at the early follow-up, and in 2.6% at the 1-year follow-up. The SAVI-registries have confirmed that transapical implantation using the ACURATE TA TM device is safe and effective in an all-comers setting with low complication rates and stable performance outcomes at short-term and 1 year; outcomes were similar between SAVI-1 and -2. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.

Synthesis of Fe16N2 compound Free-Standing Foils with 20 MGOe Magnetic Energy Product by Nitrogen Ion-Implantation

PubMed Central

Jiang, Yanfeng; Mehedi, Md Al; Fu, Engang; Wang, Yongqiang; Allard, Lawrence F.; Wang, Jian-Ping

2016-01-01

Rare-earth-free magnets are highly demanded by clean and renewable energy industries because of the supply constraints and environmental issues. A promising permanent magnet should possess high remanent magnetic flux density (Br), large coercivity (Hc) and hence large maximum magnetic energy product ((BH)max). Fe16N2 has been emerging as one of promising candidates because of the redundancy of Fe and N on the earth, its large magnetocrystalline anisotropy (Ku > 1.0 × 107 erg/cc), and large saturation magnetization (4πMs > 2.4 T). However, there is no report on the formation of Fe16N2 magnet with high Br and large Hc in bulk format before. In this paper, we successfully synthesize free-standing Fe16N2 foils with a coercivity of up to 1910 Oe and a magnetic energy product of up to 20 MGOe at room temperature. Nitrogen ion implantation is used as an alternative nitriding approach with the benefit of tunable implantation energy and fluence. An integrated synthesis technique is developed, including a direct foil-substrate bonding step, an ion implantation step and a two-step post-annealing process. With the tunable capability of the ion implantation fluence and energy, a microstructure with grain size 25–30 nm is constructed on the FeN foil sample with the implantation fluence of 5 × 1017/cm2. PMID:27145983

Synthesis of Fe16N2 compound Free-Standing Foils with 20 MGOe Magnetic Energy Product by Nitrogen Ion-Implantation.

PubMed

Jiang, Yanfeng; Mehedi, Md Al; Fu, Engang; Wang, Yongqiang; Allard, Lawrence F; Wang, Jian-Ping

2016-05-05

Rare-earth-free magnets are highly demanded by clean and renewable energy industries because of the supply constraints and environmental issues. A promising permanent magnet should possess high remanent magnetic flux density (Br), large coercivity (Hc) and hence large maximum magnetic energy product ((BH)max). Fe16N2 has been emerging as one of promising candidates because of the redundancy of Fe and N on the earth, its large magnetocrystalline anisotropy (Ku > 1.0 × 10(7) erg/cc), and large saturation magnetization (4πMs > 2.4 T). However, there is no report on the formation of Fe16N2 magnet with high Br and large Hc in bulk format before. In this paper, we successfully synthesize free-standing Fe16N2 foils with a coercivity of up to 1910 Oe and a magnetic energy product of up to 20 MGOe at room temperature. Nitrogen ion implantation is used as an alternative nitriding approach with the benefit of tunable implantation energy and fluence. An integrated synthesis technique is developed, including a direct foil-substrate bonding step, an ion implantation step and a two-step post-annealing process. With the tunable capability of the ion implantation fluence and energy, a microstructure with grain size 25-30 nm is constructed on the FeN foil sample with the implantation fluence of 5 × 10(17)/cm(2).

Thoracic Radiculopathy following Spinal Cord Stimulator Implantation Treated with Corticosteroids.

PubMed

Ghosh, Ritam; Holland, Ryan; Mammis, Antonios

2017-04-01

Spinal cord stimulation has been used since 1967 to manage chronic neuropathic pain. Although effective, the literature describes the complication rate to be as high as 35%. One rare complication following spinal cord stimulator (SCS) implantation is the development of radicular pain. We present a case series of 2 patients implanted with SCSs who developed thoracic radiculopathy following implantation that resolved with corticosteroids. Although this complication was previously thought to require surgical intervention, this case series describes the use of corticosteroids to resolve postimplantation thoracic radiculopathy. Two patients were studied in this case series who received permanent thoracic implantation of a paddle lead SCS. Several days later, both developed back pain radiating toward the umbilicus in a dermatomal pattern consistent with thoracic radiculopathy. Corticosteroids were administered to relieve this pain. One received 6 mg dexamethasone intravenously every 6 hours followed by an oral dexamethasone taper for 1 week. The other was treated with an oral methylprednisolone taper for 2 weeks. Upon follow-up, both patients no longer complained of the thoracic radiculopathy and were satisfied with the pain relief the stimulators provided. In conclusion, postsurgical radicular pain is a rare but troubling complication of SCS implantation. In order to avoid further surgical complications or the need to explant a device that provides satisfactory paresthesia coverage, pharmacologic management is desirable. This case series has demonstrated that the use of corticosteroids can effectively resolve postimplantation thoracic radicular pain in a specific subgroup of patients. Copyright © 2017 Elsevier Inc. All rights reserved.

Conventional Versus Automated Implantation of Loose Seeds in Prostate Brachytherapy: Analysis of Dosimetric and Clinical Results

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

Genebes, Caroline, E-mail: genebes.caroline@claudiusregaud.fr; Filleron, Thomas; Graff, Pierre

2013-11-15

Purpose: To review the clinical outcome of I-125 permanent prostate brachytherapy (PPB) for low-risk and intermediate-risk prostate cancer and to compare 2 techniques of loose-seed implantation. Methods and Materials: 574 consecutive patients underwent I-125 PPB for low-risk and intermediate-risk prostate cancer between 2000 and 2008. Two successive techniques were used: conventional implantation from 2000 to 2004 and automated implantation (Nucletron, FIRST system) from 2004 to 2008. Dosimetric and biochemical recurrence-free (bNED) survival results were reported and compared for the 2 techniques. Univariate and multivariate analysis researched independent predictors for bNED survival. Results: 419 (73%) and 155 (27%) patients with low-riskmore » and intermediate-risk disease, respectively, were treated (median follow-up time, 69.3 months). The 60-month bNED survival rates were 95.2% and 85.7%, respectively, for patients with low-risk and intermediate-risk disease (P=.04). In univariate analysis, patients treated with automated implantation had worse bNED survival rates than did those treated with conventional implantation (P<.0001). By day 30, patients treated with automated implantation showed lower values of dose delivered to 90% of prostate volume (D90) and volume of prostate receiving 100% of prescribed dose (V100). In multivariate analysis, implantation technique, Gleason score, and V100 on day 30 were independent predictors of recurrence-free status. Grade 3 urethritis and urinary incontinence were observed in 2.6% and 1.6% of the cohort, respectively, with no significant differences between the 2 techniques. No grade 3 proctitis was observed. Conclusion: Satisfactory 60-month bNED survival rates (93.1%) and acceptable toxicity (grade 3 urethritis <3%) were achieved by loose-seed implantation. Automated implantation was associated with worse dosimetric and bNED survival outcomes.« less

Surgical outcomes and nipple projection using the modified skate flap for nipple-areolar reconstruction in a series of 422 implant reconstructions.

PubMed

Zhong, Toni; Antony, Anu; Cordeiro, Peter

2009-05-01

Numerous techniques have been used in an attempt to achieve long-term nipple projection following nipple-areolar reconstruction (NAR). A common setback, however, is the diminution of projection over time; this phenomenon is particularly evident following implant based breast reconstruction. The purpose of this report was thus to evaluate surgical outcomes and long-term nipple projection with the use of "modified skate flap" technique in exclusively implant based postmastectomy reconstructions. A retrospective review was performed for the period between 1993 and 2007. All consecutive patients with 2-staged tissue expander/implant reconstructions followed by NAR using the modified skate flap technique performed by the senior author (P.C.) were identified in a prospectively maintained breast reconstruction database. Only patients with a minimum of 1-year follow-up were included in the study. Patients with a history of irradiation to the breast were excluded from nipple projection assessment. Clinical outcome measurements included long-term nipple projection as well as incidence of complications from the NAR procedure using the modified skate flap technique. Over the 15-year study period, 475 patients underwent 2-staged tissue expander/implant reconstruction followed by NAR using the modified skate flap technique. Of these, there was a total of 292 patients with the minimum requirement of 1-year follow-up post NAR (61% follow-up rate). The total number of reconstructed nipple areolar complexes evaluated in this series was 422 (130 bilateral and 162 unilateral NAR). Forty patients (28 unilateral and 12 bilateral NAR) who received radiation to their breasts were excluded from nipple projection assessment. At a median follow-up of 44 months (range: 12-84 months), mean nipple projection was 2.5 mm (range: 1-4 mm). Minor complications occurred in 7.2% of the patients (n = 292). Skin graft donor site dehiscence was the most common complication (3.1%) followed by partial skin graft nontake of the areola (2.1%). This report documents the largest series of NAR using a single technique in the setting of postmastectomy reconstructions. This technique can be safely performed over breast implants with acceptably low rates of complications and predictable results. Long-term nipple projection over implant reconstructions using this technique is modest and this must be forewarned to patients completing the final stage of their implant reconstruction.

Nitinol Esophageal Stents: New Designs and Clinical Indications

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

Strecker, Ernst-Peter; Boos, Irene; Vetter, Sylvia

1996-11-15

Purpose: To evaluate the clinical use of covered and noncovered, knitted nitinol stents in patients presenting new stent indications. Methods: Self-expandable, knitted nitinol stents were implanted in four patients for treatment of dysphagia. In two patients who had malignant strictures and had esophago-respiratory fistulae and in one patient with an esophagocutaneous fistula, polytetrafluoroethylene (PTFE)-covered stents were implanted. One patient received a noncovered stent, but a retrograde approach through a percutaneous endoscopic gastrostomy (PEG) fistula had to be chosen for recanalization of an esophageal occlusion. Two patients received stents for treatment of benign strictures. Results: Recanalization of the stricture and stentmore » implantation were performed under fluoroscopic control without any procedure-related morbidity or mortality. Dysphagia improved in all patients and the esophageal fistulae could be sealed off by covered stents. During a maximum follow-up of 18 months, there was no stent migration or esophageal perforation. Complications observed were stent stenosis due to food impaction (1/4) and benign stent stenosis (2/2). Most complications could be treated by the interventional radiologist. Conclusion: Self-expandable, covered Nitinol stents provide an option for the treatment of dysphagia combined with esophageal fistulae. In combination with interventional radiology techniques, even complex strictures are accessible. For benign strictures, the value of stent treatment has not yet been proven.« less

Immediate Implant-based Prepectoral Breast Reconstruction Using a Vertical Incision

PubMed Central

Lind, Jeffrey G.; Hopkins, Elizabeth G.

2015-01-01

Background: Ideally, breast reconstruction is performed at the time of mastectomy in a single stage with minimal scarring. However, postoperative complications with direct-to-implant subpectoral reconstruction remain significant. These include asymmetry, flap necrosis, animation deformity, and discomfort. We report on a series of patients who have undergone immediate single-stage prepectoral, implant-based breast reconstruction with a smooth, adjustable saline implant covered with mesh/acellular dermal matrix for support using a vertical mastectomy incision. This technique, when combined with an adjustable implant, addresses the complications related to subpectoral implant placement of traditional expanders. Our follow-up time, 4.6 years (55 months), shows a low risk of implant loss and elimination of animation deformity while also providing patients with a safe and aesthetically pleasing result. Methods: All patients who underwent immediate implant-based prepectoral breast reconstruction using a vertical mastectomy incision as a single-staged procedure were included. Charts were reviewed retrospectively. Adjustable smooth round saline implants and mesh/acellular dermal matrix were used for fixation in all cases. Results: Thirty-one patients (62 breasts) underwent single-staged implant-based prepectoral breast reconstruction using a vertical mastectomy incision. Postoperative complications occurred in 9 patients, 6 of which were resolved with postoperative intervention while only 2 cases resulted in implant loss. Conclusions: There can be significant morbidity associated with traditional subpectoral implant-based breast reconstruction. As an alternative, the results of this study show that an immediate single-stage prepectoral breast reconstruction with a smooth saline adjustable implant, using a vertical incision, in conjunction with mesh/matrix support can be performed with excellent aesthetic outcomes and minimal complications. PMID:26180713

Pregnancy rates in HIV-positive women using contraceptives and efavirenz-based or nevirapine-based antiretroviral therapy in Kenya: a retrospective cohort study.

PubMed

Patel, Rena C; Onono, Maricianah; Gandhi, Monica; Blat, Cinthia; Hagey, Jill; Shade, Starley B; Vittinghoff, Eric; Bukusi, Elizabeth A; Newmann, Sara J; Cohen, Craig R

2015-11-01

Concerns have been raised about efavirenz reducing the effectiveness of contraceptive implants. We aimed to establish whether pregnancy rates differ between HIV-positive women who use various contraceptive methods and either efavirenz-based or nevirapine-based antiretroviral therapy (ART) regimens. We did this retrospective cohort study of HIV-positive women aged 15-45 years enrolled in 19 HIV care facilities supported by Family AIDS Care and Education Services in western Kenya between Jan 1, 2011, and Dec 31, 2013. Our primary outcome was incident pregnancy diagnosed clinically. The primary exposure was a combination of contraceptive method and efavirenz-based or nevirapine-based ART regimen. We used Poisson models, adjusting for repeated measures, and demographic, behavioural, and clinical factors, to compare pregnancy rates among women receiving different contraceptive and ART combinations. 24,560 women contributed 37,635 years of follow-up with 3337 incident pregnancies. In women using implants, adjusted pregnancy incidence was 1.1 per 100 person-years (95% CI 0.72-1.5) for nevirapine-based ART users and 3.3 per 100 person-years (1.8-4.8) for efavirenz-based ART users (adjusted incidence rate ratio [IRR] 3.0, 95% CI 1.3-4.6). In women using depot medroxyprogesterone acetate, adjusted pregnancy incidence was 4.5 per 100 person-years (95% CI 3.7-5.2) for nevirapine-based ART users and 5.4 per 100 person-years (4.0-6.8) for efavirenz-based ART users (adjusted IRR 1.2, 95% CI 0.91-1.5). Women using other contraceptive methods, except for intrauterine devices and permanent methods, had 3.1-4.1 higher rates of pregnancy than did those using implants, with 1.6-2.8 higher rates in women using efavirenz-based ART. Although HIV-positive women using implants and efavirenz-based ART had a three-times higher risk of contraceptive failure than did those using nevirapine-based ART, these women still had lower contraceptive failure rates than did those receiving all other contraceptive methods except for intrauterine devices and permanent methods. Guidelines for contraceptive and ART combinations should balance the failure rates for each contraceptive method and ART regimen combination against the high effectiveness of implants. None. Copyright © 2015 Elsevier Ltd. All rights reserved.

76 FR 60938 - Advisory Committee on the Medical Uses of Isotopes; Meeting Notice

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-30

...The U.S. Nuclear Regulatory Commission (NRC) will convene a teleconference meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on October 18, 2011, to discuss the ACMUI Permanent Implant Brachytherapy Subcommittee Report. A copy of the agenda for the meeting will be available at http://www.nrc.gov/reading-rm/doc- collections/acmui/agenda or by contacting Ms. Ashley Cockerham using the information below.

Use of Self-Expanding Metallic Ureteral Stents in the Secondary Treatment of Ureteral Stenosis Following Kidney Transplantation.

PubMed

Xu, Guibin; Li, Xun; He, Yongzhong; Zhao, Haibo; Yang, Weiqing; Xie, Qingling

2015-10-01

To evaluate the safety and efficacy of self-expanding metal stents in the treatment of ureteral stenosis following kidney transplantation. Seven patients who developed benign stenosis after kidney transplantation were treated by a self-expanding metallic stent implantation from June 2007 to March 2014. All patients had undergone at least one open surgical procedure and one endourologic procedure for treatment of the stenosis. The extent of stenosis varied from 1.2 to 3.7 cm. Ultrasonography, urography, diuretic renography, and urine culture were performed every 3 months after stent insertion. Ureteroscopic examination was performed when needed. Stent placement was technically effective in all cases. The mean operative time was 37 minutes (range, 26-59 minutes). Lower urinary-tract symptoms and the ipsilateral flank pain were common early-stage complications and were greatly relieved after an average of 3 months. The mean follow-up duration was 38 months (range, 13-86 months), and no stent migration or fragmentation was observed. Urothelial hyperplasia occurred in only one patient and was effectively managed with a Double-J stent. Five patients had normal stable renal function; the remaining two had impaired renal function, including one patient with a preoperative renal failure who required dialysis at the end of the follow-up period (36 months). As an alternative to open surgery, implantation of a self-expanding metal stent is a safe and effective treatment for ureteral stenosis in patients who have undergone kidney transplantation.

Mondani intraoral welding: historical process and main practical applications.

PubMed

Dal Carlo, L; Pasqualini, M E; Mondani, P M; Rossi, F; Moglioni, E; Shulman, M

2017-01-01

The intraoral welder was invented by Dr. Pierluigi Mondani during the early 70’s to weld titanium needle implants to a titanium bar in patient’s mouth and to load them immediately by means of resin prosthesis. The clinical use documented dates back to 1972. Over the years, many practical applications have been added to the initial one, which have expanded the use of this device. In this scientific work, main applications are described. The aim of the work was to trace the historical process of intra-oral welding according to Mondani and describe the main practical applications. Intra-oral welding is a process introduced by dr. Pier Luigi Mondani of Genova (Italy) which allows to firmly conjoin titanium implants of any shape by means of a titanium bar or also directly between them in the mouth during surgery. The immediate stabilization achieved by intraoral welding increases implants success rate, allows immediate loading even in situations of bone atrophy, saves implants that are running into failure, re-evaluates fractured implants, allows to stabilize submerged implants postponing prosthesis management, allows to achieve efficient rehabilitation protocols to deal with difficult cases. The 40-years’ experience with intra-oral welding described in this article, confirms the ease of use and efficiency in providing immediate stabilization of titanium implants of all types.

Visual implant elastomer mark retention through metamorphosis in amphibian larvae

USGS Publications Warehouse

Campbell Grant, Evan H.

2008-01-01

Questions in population ecology require the study of marked animals, and marks are assumed to be permanent and not overlooked by observers. I evaluated retention through metamorphosis of visual implant elastomer marks in larval salamanders and frogs and assessed error in observer identification of these marks. I found 1) individual marks were not retained in larval wood frogs (Rana sylvatica), whereas only small marks were likely to be retained in larval salamanders (Eurycea bislineata), and 2) observers did not always correctly identify marked animals. Evaluating the assumptions of marking protocols is important in the design phase of a study so that correct inference can be made about the population processes of interest. This guidance should be generally useful to the design of mark–recapture studies, with particular application to studies of larval amphibians.

Pudendal nerve neuromodulation with neurophysiology guidance: a potential treatment option for refractory chronic pelvi-perineal pain.

PubMed

Carmel, Maude; Lebel, Michel; Tu, Le Mai

2010-05-01

Refractory chronic pelvi-perineal pain (RCPPP) is a challenging entity that has devastating consequences for patient's quality of life. Many etiologies have been proposed including pudendal neuralgia. Multiple treatment options are used but the reported results are sub-optimal and temporary. In this article, we present the technique of pudendal nerve neuromodulation with neurophysiology guidance as a treatment option for RCPPP. This technique is a two-step procedure that includes electrode implantation under neurophysiology guidance followed by the implantation of a permanent generator after a successful trial period. We report the cases of three women who underwent this procedure as a last-resort treatment option. After 2 years of follow-up, their symptoms are still significantly improved. No major complication occurred.

Preliminary Thermal Characterization of a Fully-Passive Wireless Backscattering Neuro-Recording Microsystem

NASA Technical Reports Server (NTRS)

Schwerdt, H. N.; Xu, W.; Shekhar, S.; Chae, J.; Miranda, F. A.

2011-01-01

We present analytical and experimental thermal characteristics of a battery-less, fully-passive wireless backscattering microsystem for recording of neuropotentials. A major challenge for cortically implantable microsystems involves minimizing the heat dissipated by on-chip circuitry, which can lead to permanent brain damage. Therefore, knowledge of temperature changes induced by implantable microsystems while in operation is of utmost importance. In this work, a discrete diode appended to the neuro-recording microsystem has been used to indirectly monitor the aforesaid temperature changes. Using this technique, the maximum temperature rise measured for the microsystem while in operation was 0.15 +/- 0.1 C, which is significantly less than current safety guidelines. Specific absorption ratio (SAR) due to the microsystem was also computed to further demonstrate fully-passive functionality of the neuro-recording microsystem.

A low-frequency versatile wireless power transfer technology for biomedical implants.

PubMed

Jiang, Hao; Zhang, Junmin; Lan, Di; Chao; Liou, Shyshenq; Shahnasser, Hamid; Fechter, Richard; Hirose, Shinjiro; Harrison, Michael; Roy, Shuvo

2013-08-01

Implantable biomedical sensors and actuators are highly desired in modern medicine. In many cases, the implant's electrical power source profoundly determines its overall size and performance . The inductively coupled coil pair operating at the radio-frequency (RF) has been the primary method for wirelessly delivering electrical power to implants for the last three decades . Recent designs significantly improve the power delivery efficiency by optimizing the operating frequency, coil size and coil distance . However, RF radiation hazard and tissue absorption are the concerns in the RF wireless power transfer technology (RF-WPTT) , . Also, it requires an accurate impedance matching network that is sensitive to operating environments between the receiving coil and the load for efficient power delivery . In this paper, a novel low-frequency wireless power transfer technology (LF-WPTT) using rotating rare-earth permanent magnets is demonstrated. The LF-WPTT is able to deliver 2.967 W power at  ∼ 180 Hz to an 117.1 Ω resistor over 1 cm distance with 50% overall efficiency. Because of the low operating frequency, RF radiation hazard and tissue absorption are largely avoided, and the power delivery efficiency from the receiving coil to the load is independent of the operating environment. Also, there is little power loss observed in the LF-WPTT when the receiving coil is enclosed by non-magnetic implant-grade stainless steel.

Bacterial biofilms on implanted suture material are a cause of surgical site infection.

PubMed

Kathju, Sandeep; Nistico, Laura; Tower, Irene; Lasko, Leslie-Ann; Stoodley, Paul

2014-10-01

Surgical site infection (SSI) has been estimated to occur in up to 5% of all procedures, accounting for up to 0.5% of all hospital costs. Bacterial biofilms residing on implanted foreign bodies have been implicated as contributing or causative factors in a wide variety of infectious scenarios, but little consideration has been given to the potential for implanted, submerged suture material to act as a host for biofilm and thus serve as a nidus of infection. We report a series of 15 patients who underwent open Roux-en-Y gastric bypass (with musculofascial closure with permanent, multifilament sutures) who developed longstanding and refractory SSIs in the abdominal wall. Explanted suture material at subsequent exploration was examined for biofilm with confocal laser-scanning microscopy (CLSM) and fluorescence in situ hybridization (FISH). All 15 patients at re-exploration were found to have gross evidence of a "slimy" matrix or dense reactive granulation tissue localized to the implanted sutures. Confocal laser-scanning microscopy revealed abundant biofilm present on all sutures examined; FISH was able to identify the presence of specific pathogens in the biofilm. Complete removal of the foreign bodies (and attendant biofilms) resulted in all cases in cure of the SSI. Bacterial biofilms on implanted suture material can manifest as persistent surgical site infections that require complete removal of the underlying foreign body substrata for resolution.

Autogenous teeth used for bone grafting: A systematic review.

PubMed

Gual-Vaqués, P; Polis-Yanes, C; Estrugo-Devesa, A; Ayuso-Montero, R; Mari-Roig, A; López-López, J

2018-01-01

Recently, bone graft materials using permanent teeth have come to light, and clinical and histological outcomes of this material have been confirmed by some studies. The aim of this systematic review was to evaluate the reliability of the autogenous tooth bone graft material applied to alveolar ridge augmentation procedures. A systematic review of literature was conducted analyzing articles published between 2007 and 2017. The following four outcome variables were defined: a) implant stability b) post-operative complication c) evaluation of implant survival and failure rates, and d) histological analysis. A total of 108 articles were identified; 6 were selected for review. Based on the PICO (problem, intervention, comparison, outcome) model, the chief question of this study was: Can patients with alveolar ridge deficiency be successfully treated with the autogenous teeth used as bone graft? The mean primary stability of the placed implants was 67.3 ISQ and the mean secondary stability was 75.5 ISQ. The dehiscence of the wound was the most frequent complication with a rate of 29.1%. Of the 182 analyzed implants, the survival rate was 97.7% and the failure rate was 2.3%. In the histological analysis, most of studies reported bone formation. There is insufficient evidence regarding the effects of autogenous teeth used for bone grafting to support any definitive conclusions, although it has been shown clinically safe and good bone forming capacity, and good results are shown about implant stability.

Hydroxyapatite coating on cobalt alloys using electrophoretic deposition method for bone implant application

NASA Astrophysics Data System (ADS)

Aminatun; M, Shovita; I, Chintya K.; H, Dyah; W, Dwi

2017-05-01

Damage on bone due to osteoporosis and cancer triggered high demand for bone implant prosthesis which is a permanent implant. Thus, a prosthesis coated with hydroxyapatite (HA) is required because it is osteoconductive that can trigger the growth of osteoblast cells. The purpose of this study is to determine the optimum concentration of HA suspension in terms of the surface morphology, coating thickness, adhesion strength and corrosion rate resulting in the HA coating with the best characteristics for bone implant. Coating using electrophoretic deposition (EPD) method with concentrations of 0.02M, 0.04M, 0.06M, 0.08M, and 0.1M was performed on the voltage and time of 120V and 30 minutes respectively. The process was followed by sintering at the temperature of 900 °C for 10 minutes. The results showed that the concentration of HA suspension influences the thickness and the adhesion of layer of HA. The higher the concentration of HA-ethanol suspension the thicker the layer of HA, but its coating adhesion strength values became lower. The concentration of HA suspension of 0.04 M is the best concentration, with characteristics that meet the standards of the bone implant prosthesis. The characteristics are HA coating thickness of 199.93 ± 4.85 μm, the corrosion rate of 0.0018 mmpy and adhesion strength of 4.175 ± 0.716 MPa.

Clinical and hemodynamic results after direct transcatheter aortic valve replacement versus pre-implantation balloon aortic valvuloplasty: A case-matched analysis.

PubMed

Ferrera, Carlos; Nombela-Franco, Luis; Garcia, Eulogio; Jimenez-Quevedo, Pilar; Biagioni, Corina; Gonzalo, Nieves; Nuñez-Gil, Ivan; Viana-Tejedor, Ana; Salinas, Pablo; Alberto de Agustin, Jose; Almeria, Carlos; Islas, Fabian; Perez de Isla, Leopoldo; Fernandez-Perez, Cristina; Escaned, Javier; Fernández-Ortiz, Antonio; Macaya, Carlos

2017-11-01

To evaluate the safety and midterm hemodynamic results of direct transcatheter aortic valve replacement (TAVR) without pre-implantation balloon aortic valvuloplasty (BAV). BAV was considered a mandatory previous step in TAVR procedures. A total of 339 consecutive patients who underwent transfemoral TAVR were prospectively selected. A 1:1 matching was conducted, pairing age, prosthesis type (self-expandable or balloon expandable) and size, and valve calcification grade (48% with moderate to severe valve calcification). Finally, 102 pairs (102 patients with previous BAV and 102 without BAV) were obtained. Direct TAVR was feasible in all patients without any crossover to BAV group. Device success was achieved in 91.2% and 90.2% of cases in direct TAVR and pre-BAV groups (P = 0.810), respectively, without any differences in balloon postdilation rate and residual aortic regurgitation. The amount of contrast agent, acute kidney injury and myocardial injury was significantly lower in the direct implantation group (P < 0.05). No differences were found in 30-day and 1-year mortality between both groups (4.9% vs. 9.8%, P = 0.177 and 14.0% vs. 23.8%, P = 0.771, respectively). Hemodynamic parameters remained stable after 1-year follow-up in both groups. Direct transfemoral TAVR without prior BAV was safe in patients with calcified severe aortic stenosis. Pre-implantation BAV could be omitted in patients undergoing TAVR, without influence in procedure success rate, and subsequent patients' clinical course and valve hemodynamic performance. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Direct transcatheter aortic valve implantation with self-expandable bioprosthesis: feasibility and safety.

PubMed

Fiorina, Claudia; Maffeo, Diego; Curello, Salvatore; Lipartiti, Felicia; Chizzola, Giuliano; D'Aloia, Antonio; Adamo, Marianna; Mastropierro, Rosy; Gavazzi, Emanuele; Ciccarese, Camilla; Chiari, Ermanna; Ettori, Federica

2014-06-01

Balloon valvuloplasty has been considered a mandatory step of the transcatheter aortic valve implantation (TAVI), although it is not without risk. The aim of this work was to evaluate the feasibility and safety of TAVI performed without pre-dilation (direct TAVI) of the stenosed aortic valve. Between June 2012 and June 2013, 55 consecutive TAVI performed without pre-dilation at our institution using the self-expandable CoreValve prosthesis (Medtronic, Minneapolis, MN) were analyzed and compared with 45 pre-dilated TAVI performed the previous year. Inclusion criteria were a symptomatic and severe aortic stenosis. Exclusion criteria were defined as presence of pure aortic regurgitation, degenerated surgical bioprosthesis or bicuspid aortic valve and prior procedure of balloon aortic valvuloplasty performed as a bridge to TAVI. High-burden calcification in the device landing zone, assessed by CT scan, was found in most of the patients. The valve size implanted was similar in both groups. Device success was higher in direct TAVI (85%vs.64%,p=0.014), mostly driven by a significant lower incidence of paravalvular leak (PVL≥2;9%vs.33%,p=0.02). Safety combined end point at 30 days was similar in both groups. Compared to TAVI with pre-dilation, direct TAVI is feasible regardless of the presence of bulky calcified aortic valve and the valve size implanted. Device success was higher in direct TAVI, mostly driven by a lower incidence of paravalvular leak. Safety at 30 days was similar in two groups. Copyright © 2014 Elsevier Inc. All rights reserved.

Mapping pocket gopher burrow systems with expanding polyurethane foam

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

Felthauser, M.; McInroy, D.

The impetus for this study arose from the need to isolate buried chemical and radioactive waste from burrowing animals. In a study of barrier materials that inhibit burrowing by pocket gophers (Thomomys spp.) into waste material, it was necessary to map tunnel systems as a function of depth and soil type. A method of mapping burrow systems was needed that would be economical, portable, useful in a variety of soil types, and give accurate, permanent records of burrow configurations. A method is described for injecting an expanding polyurethane foam to map burrow systems in situ.

The development of bioresorbable composite polymeric implants with high mechanical strength

NASA Astrophysics Data System (ADS)

Sharma, Upma; Concagh, Danny; Core, Lee; Kuang, Yina; You, Changcheng; Pham, Quynh; Zugates, Greg; Busold, Rany; Webber, Stephanie; Merlo, Jonathan; Langer, Robert; Whitesides, George M.; Palasis, Maria

2018-01-01

Implants for the treatment of tissue defects should mimic the mechanical properties of the native tissue of interest and should be resorbable as well as biocompatible. In this work, we developed a scaffold from variants of poly(glycolic) acid which were braided and coated with an elastomer of poly(glycolide-co-caprolactone) and crosslinked. The coating of the scaffold with the elastomer led to higher mechanical strength in terms of compression, expansion and elasticity compared to braids without the elastomer coating. These composite scaffolds were found to have expansion properties similar to metallic stents, utilizing materials which are typically much weaker than metal. We optimized the mechanical properties of the implant by tuning the elastomer branching structure, crosslink density, and molecular weight. The scaffolds were shown to be highly resorbable following implantation in a porcine femoral artery. Biocompatibility was studied in vivo in an ovine model by implanting the scaffolds into femoral arteries. The scaffolds were able to support an expanded open lumen over 12 months in vivo and also fully resorbed by 18 months in the ovine model.

[Self-expandable metallic biliary endoprosthesis in malignant obstructive jaundice].

PubMed

Güitrón-Cantú, Alfredo; Adalid-Martínez, Raúl; Gutiérrez-Bermúdez, José A

2005-01-01

Implantation of metallic stents for malignant biliary strictures has been recognized to be effective alternatives. To show our experience in metallic stents for palliation of malignant biliary strictures. Seventy three patients (38 males, 35 females, mean age 64.26) with malignant biliary strictures have been treated by implantation of metallic stents. Causes of obstruction were pancreatic carcinoma (23/73, 31.5%), bile duct carcinoma (31/73, 42.5%), carcinoma of ampula of Vater (11/73, 15%) and Klatskin tumor (3/73, 4.1%). Endoscopic procedure was successful in all cases. Neither procedure-related morbidity nor mortality was observed. Life surviving curve was 9 months and showed significant difference (p < 0.0071) in patients with carcinoma of ampula of Vater. Self-expanding metal endoprosthesis is a recognized method of palliation in malignant biliary obstruction. It efficiently relieves jaundice and generally improves comfort and nutritional status during the patient's remaining lifetime. The metallic stents are advantageous in patients surviving 6 months or less.

Porous and nonporous orbital implants for treating the anophthalmic socket: A meta-analysis of case series studies.

PubMed

Schellini, Silvana; Jorge, Eliane; Sousa, Roberta; Burroughs, John; El-Dib, Regina

2016-01-01

To assess the efficacy and safety of porous and nonporous implants for management of the anophthalmic socket. Case series meta-analysis was conducted with no language restriction, including studies from: PUBMED, EMBASE and LILACS. Study eligibility criteria were case series design with more than 20 cases reported, use of porous and/or nonporous orbital implants, anophthalmic socket and, treatment success defined as no implant exposure or extrusion. Complications rates from each included study were quantified. Proportional meta-analysis was performed on both outcomes with a random-effects model and the 95% confidential intervals were calculated. A total of 35 case series studies with a total of 3,805 patients were included in the meta-analysis. There are no studies comparing porous and nonporous implants in the anophthalmic socket treatment. There was no statistically significant difference between porous polyethylene (PP) and hydroxyapatite (HA) on implant exposure: 0.026 (0.012-0.045) vs 0.054 (0.041-0.070), respectively and, neither on implant extrusion: 0.0042 (0.0008-0.010) vs. 0.018 (0.004-0.042), respectively. However, there was a significant difference supporting the use of PP when compared to bioceramic implant: 0.026 (0.012 -0.045) vs. 0.12 (0.06-0.20), respectively, on implant exposure. PP implants showed lower chance of exposure than bioceramic implant for anophthalmic socket reconstruction, although we cannot rule out the possibility of heterogeneity bias due to the nature and level of evidence of the included studies. Clinical trials are necessary to expand the knowledge of porous and nonporous orbital implants in the anophthalmic socket management.

Breast-implant texturing associated with delamination of capsular layers: A histological analysis of the double capsule phenomenon.

PubMed

Efanov, J I; Giot, J P; Fernandez, J; Danino, M A

2017-06-01

Macro-texturing of breast implants was developed with the double goal of improving implant stabilization within the breast cavity and decreasing the rate of capsular contractures. However, recent evidence suggests that double capsular formation, a potentially worrisome phenomenon associated with late seromas and biofilms, occurs with preponderance in macro-textured implants. Our objective was to analyze histologically different regions of double capsules to determine if they are more prone to mechanical movements. A prospective analysis including patients undergoing second-stage expander to definitive breast-implant reconstruction post-mastectomy was conducted after intraoperative identification of the double capsule phenomenon. Two samples were collected from each capsules around the implant, located centrally and laterally. The specimens were sent for histological analysis by the institution's pathologist. In total, 10 patients were identified intraoperatively with partial double capsule phenomenon. Among samples retrieved from the lateral aspect of the breast implant, all were associated with delamination and fractures in the collagen matrix of the double capsules. This phenomenon was not observed in any sample from the dome of the breast. Breast-implant macro-texturing plays an important role on delamination of capsules on lateral portions of the breast, which may have an etiologic role in double capsule formation. Manufacturing implants with macro-texturing on one side and smooth surface on the other could diminish mechanical shear forces responsible for these findings. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Prosthetic metal implants and airport metal detectors.

PubMed

Ismail, A; Dancey, A; Titley, O G

2013-04-01

Metal detectors have been present in airports and points of departure for some time. With the introduction of heightened security measures in response to fears of an increased threat of terrorism, they may become more prevalent in other public locations. The aim of this study was to ascertain which prosthetic devices activated metal detector devices used for security purposes. A range of prosthetic devices used commonly in orthopaedic and plastic surgery procedures were passed through an arch metal detector at Birmingham Airport in the UK. Additionally, each item was passed under a wand detector. Items tested included expandable breast prostheses, plates used in wrist and hand surgery, screws, K-wires, Autosuture™ ligation clips and staples. No prostheses were detected by the arch detector. The expandable implants and wrist plates were the only devices detected by passing the wand directly over them. No device was detected by the wand when it was under cover of the axillary soft tissue. Screws, K-wires, Autosuture™ clips and staples were not detected under any of the study conditions. Although unlikely to trigger a detector, it is possible that an expandable breast prosthesis or larger plate may do so. It is therefore best to warn patients of this so they can anticipate detection and further examination.