Outcomes in African Americans undergoing cardioverter-defibrillator implantation for primary prevention of sudden cardiac death: findings from the Prospective Observational Study of Implantable Cardioverter-Defibrillators (PROSE-ICD).

PubMed

Zhang, Yiyi; Kennedy, Robert; Blasco-Colmenares, Elena; Butcher, Barbara; Norgard, Sanaz; Eldadah, Zayd; Dickfeld, Timm; Ellenbogen, Kenneth A; Marine, Joseph E; Guallar, Eliseo; Tomaselli, Gordon F; Cheng, Alan

2014-08-01

Implantable cardioverter-defibrillators (ICDs) reduce the risk of death in patients with left ventricular dysfunction. Little is known regarding the benefit of this therapy in African Americans (AAs). The purpose of this study was to determine the association between AA race and outcomes in a cohort of primary prevention ICD patients. We conducted a prospective cohort study of patients with systolic heart failure who underwent ICD implantation for primary prevention of sudden cardiac death. The primary end-point was appropriate ICD shock defined as a shock for rapid ventricular tachyarrhythmias. The secondary end-point was all-cause mortality. There were 1189 patients (447 AAs and 712 non-AAs) enrolled. Over a median follow-up of 5.1 years, a total of 137 patients experienced an appropriate ICD shock, and 343 died (294 of whom died without receiving an appropriate ICD shock). The multivariate adjusted hazard ratio (95% confidence interval) comparing AAs vs non-AAs were 1.24 (0.96-1.59) for all-cause mortality, 1.33 (1.02, 1.74) for all-cause mortality without receiving appropriate ICD shock, and 0.78 (0.51, 1.19) for appropriate ICD shock. Ejection fraction, diabetes, and hypertension appeared to explain 24.1% (10.1%-69.5%), 18.7% (5.3%-58.0%), and 13.6% (3.8%-53.6%) of the excess risk of mortality in AAs, with a large proportion of the mortality difference remaining unexplained. In patients with primary prevention ICDs, AAs had an increased risk of dying without receiving an appropriate ICD shock compared to non-AAs. Copyright © 2014 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

A Comparison of the Quality of Life of Patients With an Entirely Subcutaneous Implantable Defibrillator System Versus a Transvenous System (from the EFFORTLESS S-ICD Quality of Life Substudy).

PubMed

Pedersen, Susanne S; Mastenbroek, Mirjam H; Carter, Nathan; Barr, Craig; Neuzil, Petr; Scholten, Marcoen; Lambiase, Pier D; Boersma, Lucas; Johansen, Jens B; Theuns, Dominic A M J

2016-08-15

The first clinical results from the Evaluation of Factors Impacting Clinical Outcome and Cost Effectiveness of the subcutaneous implantable cardioverter defibrillator (EFFORTLESS S-ICD) Registry on the entirely S-ICD system are promising, but the impact of the S-ICD system on patients' quality of life (QoL) is not known. We evaluated the QoL of patients with an S-ICD against an unrelated cohort with a transvenous (TV)-ICD system during 6 months of follow-up. Consecutively implanted patients with an S-ICD system were matched with patients with a TV-ICD system on a priori selected variables including baseline QoL. QoL was measured with the Short-Form Health Survey at baseline, 3, and 6 months after implant and compared using multivariable modeling with repeated measures. Patients with an S-ICD (n = 167) versus a TV-ICD system (n = 167) did not differ significantly on physical (p = 0.8157) and mental QoL scores (p = 0.9080) across baseline, 3, and 6 months after implantation in adjusted analyses. The evolution in physical (p = 0.0503) and mental scores (p = 0.3772) during follow-up was similar for both cohorts, as indicated by the nonsignificant interaction effect for ICD system by time. Both patients with an S-ICD system and a TV-ICD system experienced significant improvements in physical and mental QoL between time of implant and 3 months (both p's <0.0001) and between time of implant and 6 months (both p's <0.0001) but not between 3 and 6 months (both p's >0.05). In conclusion, these first results show that the QoL of patients with an S-ICD versus TV-ICD system is similar and that patients with either system experience improvements in QoL on the short term. Copyright © 2016 Elsevier Inc. All rights reserved.

Canadian Registry of ICD Implant Testing procedures (CREDIT): current practice, risks, and costs of intraoperative defibrillation testing.

PubMed

Healey, Jeff S; Dorian, Paul; Mitchell, L Brent; Talajic, Mario; Philippon, Francois; Simpson, Chris; Yee, Raymond; Morillo, Carlos A; Lamy, Andre; Basta, Magdy; Birnie, David H; Wang, Xiaoyin; Nair, Girish M; Crystal, Eugene; Kerr, Charles R; Connolly, Stuart J

2010-02-01

There is uncertainty about the proper role of defibrillation testing (DT) at the time of implantable cardioverter defibrillator (ICD) insertion. A prospective registry was conducted at 13 sites in Canada between January 2006 and October 2007. To document the details of DT, the reasons for not conducting DT, and the costs and complications associated with DT. DT was conducted at implantation in 230 of 361 patients (64%). DT was more likely to be conducted for new implants compared with impulse generator replacements (71% vs 32%, P = 0.0001), but was similar for primary and secondary prevention indications (64% vs 63%, P = NS). Among patients not having DT, the reason(s) given were: considered unnecessary (44%); considered unsafe, mainly due to persistent atrial fibrillation (37%); lack of an anesthetist (20%); and, patient or physician preference (6%). When performed, DT consisted of a single successful shock > or = 10J below maximum device output in 65% of cases. A 10J safety-margin was met by 97% of patients, requiring system modification in 2.3%. Major perioperative complications occurred in 4.4% of patients having DT versus 6.6% of patients not having DT (P = NS). ICD insertion was $844 more expensive for patients having DT (P = 0.16), largely due to increased costs ($28,017 vs $24,545) among patients having impulse generator replacement (P = 0.02). DT was not performed in a third of ICD implants, usually due to a perceived lack of need or relative contraindication.

The subcutaneous ICD as an alternative to the conventional ICD system: Initial experience in Greece and a review of the literature.

PubMed

Sideris, Skevos; Archontakis, Stefanos; Gatzoulis, Konstantinos A; Anastasakis, Aristotelis; Sotiropoulos, Ilias; Arsenos, Petros; Kasiakogias, Alexandros; Terentes, Dimitrios; Trachanas, Konstantinos; Paschalidis, Eleftherios; Tousoulis, Dimitrios; Kallikazaros, Ioannis

The introduction of an implantable cardioverter defibrillator (ICD) in clinical practice has revolutionized our therapeutic approach for both primary and secondary prevention of sudden cardiac death (SCD), as it has proven to be superior to medical therapy in treating potentially life-threatening ventricular arrhythmias and has resulted in reduced mortality rates. However, implantation of a conventional ICD carries a non-negligible risk of periprocedural and long-term complications associated with the transvenous ICD leads. The entirely subcutaneous implantable cardioverter defibrillator (S-ICD) has recently emerged as a therapeutic alternative to the conventional ICD for patients with various cardiopathies and who are at high risk of SCD. The main advantage is the avoidance of vascular access and thus avoidance of complications associated with transvenous leads. Patients without pacing indications, such as bradycardia, a need for antitachycardia pacing or cardiac resynchronization, as well as those at higher risk of complications from transvenous lead implantation are perfect candidates for this novel technology. The subcutaneous ICD has proven to be equally safe and effective compared to transvenous ICD systems in early clinical trials. Further technical improvements of the system will likely lead to the expansion of indications and widespread use of this technology. In the present review, we discuss the indications for this system, summarize early clinical experiences and highlight the advantages and disadvantages of this novel technology. In addition, we present the first two cases of subcutaneous cardioverter defibrillator system implantation in Greece. Copyright © 2017 Hellenic Society of Cardiology. Published by Elsevier B.V. All rights reserved.

[Restrictions for ICD patients in daily life].

PubMed

Köbe, Julia; Gradaus, Rainer; Zumhagen, Sven; Böcker, Dirk

2005-11-01

Patients with an implantable cardioverter defibrillator (ICD) may experience loss of consciousness. Electromagnetic interference (EMI) may trigger undesired or inhibit necessary therapy in patients with an ICD. Therefore, questions about personal or professional activities for ICD patients arise. Restricting driving or other personal activities has adverse effects on the patient's quality of life. The national Societies of Cardiology provide recommendations for ICD patients concerning driving of motor vehicles. Patients with an ICD that is implanted prophylactically do not have to refrain from driving after recovery from the implantation procedure. Patients with arrhythmias are classified into different groups depending on the risk of recurrence of tachycardias and symptoms. Commercial driving is not allowed for patients with an ICD in Germany except for those with a prophylactic indication without a history of arrhythmias. Those patients may drive small cars but no trucks or busses. Guidelines for medical fitness in commercial or military flying are regulated by the Joint Aviation Authorities (JAA) and ventricular tachycardias are a contraindication for both. Fortunately, loss of consciousness is not dangerous in most jobs. Strong sources of EMI can occur at special workplaces. Patients have to be advised and tested individually concerning their risk for EMI at their employment site before returning safely. Modern life exposes to an increasing amount of EMI. Intact household devices usually do not interfere with ICDs. Mobile phones may interfere with implanted devices. Interaction can be minimized by special precautions like maintaining a distance of minimum 10 cm between mobile phone and ICD. Electronic surveillance systems work differently and have the potential to interact with devices. Patients should be advised to pass those systems with avoiding longer exposure. The presence of an ICD is presently a contraindication for undergoing magnetic resonance imaging

Rationale and design of the MONITOR-ICD study: a randomized comparison of economic and clinical effects of automatic remote MONITORing versus control in patients with Implantable Cardioverter Defibrillators.

PubMed

Zabel, Markus; Müller-Riemenschneider, Falk; Geller, J Christoph; Brachmann, Johannes; Kühlkamp, Volker; Dissmann, Rüdiger; Reinhold, Thomas; Roll, Stephanie; Lüthje, Lars; Bode, Frank; Eckardt, Lars; Willich, Stefan N

2014-10-01

Implantable cardioverter defibrillator (ICD) remote follow-up and ICD remote monitoring (RM) are established means of ICD follow-up. The reduction of the number of in-office visits and the time to decision is proven, but the true clinical benefit is still unknown. Cost and cost-effectiveness of RM remain leading issues for its dissemination. The MONITOR-ICD study has been designed to assess costs, cost-effectiveness, and clinical benefits of RM versus standard-care follow-up in a prospective multicenter randomized controlled trial. Patients indicated for single- or dual-chamber ICD are eligible for the study and are implanted an RM-capable Biotronik ICD (Lumax VR-T or Lumax DR-T; Biotronik SE & Co KG, Berlin, Germany). Implantable cardioverter defibrillator programming and alert-based clinical responses in the RM group are highly standardized by protocol. As of December 2011, recruitment has been completed, and 416 patients have been enrolled. Subjects are followed-up for a minimum of 12months and a maximum of 24months, ending in January 2013. Disease-specific costs from a societal perspective have been defined as primary end point and will be compared between RM and standard-care groups. Secondary end points include ICD shocks (including appropriate and inappropriate shocks), cardiovascular hospitalizations and cardiovascular mortality, and additional health economic end points. The MONITOR-ICD study will be an important randomized RM study to report data on a primary economic end point in 2014. Its results on ICD shocks will add to the currently available evidence on clinical benefit of RM. Copyright © 2014 Mosby, Inc. All rights reserved.

Inadvertent transposition of defibrillator coil terminal pins causing inappropriate ICD therapies.

PubMed

Issa, Ziad F

2008-06-01

We report the case of a 65-year-old man with chronic atrial fibrillation (AF) and severe ischemic cardiomyopathy who underwent implantation of a prophylactic single-chamber implantable cardioverter-defibrillator (ICD). The patient experienced inappropriate ICD therapies due to oversensing of pectoral muscle myopotential secondary to reversal of the defibrillator coil terminal pins in the ICD header. Recognizing this possibility is important to avoid misinterpretation of spontaneous oversensing as hardware failure (e.g., lead fracture or insulation breech) and potentially unnecessary ICD system surgical intervention, including lead extraction.

How does an implantable cardioverter defibrillator (ICD) affect the lives of patients and their families?

PubMed

Eckert, Marion; Jones, Tina

2002-06-01

This study aimed to identify the lived experience of patients with implantable cardioverter defibrillators (ICD) and their families. The methodology used was interpretative phenomenology. Unstructured interviews were conducted with three family members and three ICD recipients. Using a methodological approach outlined by van Manen, the participants transcribed texts were analysed looking for similar concepts and ideas that developed into themes that explicated the meaning of this phenomena. The themes that emerged were: dependence, which encompassed their perceptions about the life-saving device; the memory of their first defibrillation experience; lifestyle changes, which incorporated modification techniques; lack of control, which highlighted feelings such as fear, anxiety and powerlessness; mind game, which illustrated psychological challenges; and the issue of security, demonstrating how 'being there' and not 'being there' impacted on their everyday lives. The long-term outcomes of living with an ICD are important considerations for all health-care providers. This research highlights the everyday activities of recipients, the lifestyle changes they have made, the emotional significance of the device and the psychological coping strategies that the participants have adopted. The findings of this research will allow health-care professionals to be better prepared to provide education and support for ICD recipients and their families in regards to issues related to insertion of the device during the postinsertion recovery period and for long-term management after hospital discharge.

Tachycardia detection in ICDs by Boston Scientific : Algorithms, pearls, and pitfalls.

PubMed

Zanker, Norbert; Schuster, Diane; Gilkerson, James; Stein, Kenneth

2016-09-01

The aim of this study was to summarize how implantable cardioverter defibrillators (ICDs) by Boston Scientific sense, detect, discriminate rhythms, and classify episodes. Modern devices include multiple programming selections, diagnostic features, therapy options, memory functions, and device-related history features. Device operation includes logical steps from sensing, detection, discrimination, therapy delivery to history recording. The program is designed to facilitate the application of the device algorithms to the individual patient's clinical needs. Features and functions described in this article represent a selective excerpt by the authors from Boston Scientific publicly available product resources. Programming of ICDs may affect patient outcomes. Patient-adapted and optimized programming requires understanding of device operation and concepts.

Heart rate turbulence predicts ICD-resistant mortality in ischaemic heart disease.

PubMed

Marynissen, Thomas; Floré, Vincent; Heidbuchel, Hein; Nuyens, Dieter; Ector, Joris; Willems, Rik

2014-07-01

In high-risk patients, implantable cardioverter-defibrillators (ICDs) can convert the mode of death from arrhythmic to pump failure death. Therefore, we introduced the concept of 'ICD-resistant mortality' (IRM), defined as death (a) without previous appropriate ICD intervention (AI), (b) within 1 month after the first AI, or (c) within 1 year after the initial ICD implantation. Implantable cardioverter-defibrillator implantation in patients with a high risk of IRM should be avoided. Implantable cardioverter-defibrillator patients with ischaemic heart disease were included if a digitized 24 h Holter was available pre-implantation. Demographic, electrocardiographic, echocardiographic, and 24 h Holter risk factors were collected at device implantation. The primary endpoint was IRM. Cox regression analyses were used to test the association between predictors and outcome. We included 130 patients, with a mean left ventricular ejection fraction (LVEF) of 33.6 ± 10.3%. During a follow-up of 52 ± 31 months, 33 patients died. There were 21 cases of IRM. Heart rate turbulence (HRT) was the only Holter parameter associated with IRM and total mortality. A higher New York Heart Association (NYHA) class and a lower body mass index were the strongest predictors of IRM. Left ventricular ejection fraction predicted IRM on univariate analysis, and was the strongest predictor of total mortality. The only parameter that predicted AI was non-sustained ventricular tachycardia. Implantable cardioverter-defibrillator implantation based on NYHA class and LVEF leads to selection of patients with a higher risk of IRM and death. Heart rate turbulence may have added value for the identification of poor candidates for ICD therapy. Available Holter parameters seem limited in their ability to predict AI. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2013. For permissions please email: journals.permissions@oup.com.

Longevity of implantable cardioverter defibrillators: a comparison among manufacturers and over time.

PubMed

von Gunten, Simon; Schaer, Beat A; Yap, Sing-Chien; Szili-Torok, Tamas; Kühne, Michael; Sticherling, Christian; Osswald, Stefan; Theuns, Dominic A M J

2016-05-01

Longevity of implantable cardioverter defibrillators (ICDs) is crucial for patients and healthcare systems as replacements impact on infection rates and cost-effectiveness. Aim was to determine longevity using very large databases of two teaching hospitals with a high number of replacements and a rather homogeneous distribution among manufacturers. The study population consists of all patients in whom an ICD was inserted in. All ICD manufacturers operating in Switzerland and the Netherlands and all implanted ICDs were included. Implantable cardioverter defibrillator replacements due to normal battery depletion were considered events, and other replacements were censored. Longevity was assessed depending on manufacturers, pacing mode, implant before/after 2006, and all parameters combined. We analysed data from 3436 patients in whom 4881 ICDs [44.2% VVI-ICDs, 27.4% DDD-ICDs, 26.3% cardiac resynchronization therapy (CRT)-ICDs, 2.0% subcutaneous ICDs] were implanted. The four major manufacturers had implant shares between 18.4 and 31.5%. Replacement due to battery depletion (27.4%) was performed for 1339 ICDs. Patient survival at 5 years was 80.1%. Longevity at 5 years improved in contemporary compared with elderly ICDs [63.9-80.6% across all ICDs, of 73.7-92.1% in VVIs, 58.2-76.1% in DDDs, and of 47.1-66.3% in CRT defibrillators, all P value < 0.05]. Remarkable differences were seen among manufacturers, and those with better performance in elderly ICDs were not those with better performance in contemporary ones. Implantable cardioverter defibrillator longevity increased in contemporary models independent of manufacturer and pacing mode. Still, significant differences exist among manufacturers. These results might impact on device selection. © The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.

MW-assisted synthesis of SVO for ICD primary batteries

NASA Astrophysics Data System (ADS)

Beninati, Sabina; Fantuzzi, Matteo; Mastragostino, Marina; Soavi, Francesca

An Ag 2V 4O 11 (SVO) cathode material prepared by microwave (MW)-assisted solid-state synthesis (MW-SVO) was developed for lithium primary batteries for implantable cardioverter/defibrillators (ICDs). This paper presents the results of physical-chemical and electrochemical characterizations of MW-SVO as well as those of SVO prepared by conventional thermal route (T-SVO). A specific effect of MWs which accelerates the synthesis reaction and contributes to yield a material of different morphology and degree of crystallinity compared with those of T-SVO was observed. The results of pulsed electrochemical tests carried out at 37 °C in operative conditions of ICDs on Li/MW-SVO batteries with cathode mass loading sized for practical use are also reported. These tests demonstrated that MW-SVO can be used for high performing lithium primary battery delivering in few seconds the specific energy values required by ICD application.

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.

Role of Automatic Wireless Remote Monitoring Immediately Following ICD Implant: The Lumos-T Reduces Routine Office Device Follow-Up Study (TRUST) Trial.

PubMed

Varma, Niraj; Epstein, Andrew E; Schweikert, Robert; Michalski, Justin; Love, Charles J

2016-03-01

The incidence of unscheduled encounters and problem occurrence between ICD implant and first in-person evaluation (IPE) recommended at 12 weeks is unknown. Automatic remote home monitoring (HM) may be useful in this potentially unstable period. ICD patients were randomized 2:1 to HM enabled post-implant (n = 908) or to conventional monitoring (CM; n = 431). Groups were compared between implant and prior to first scheduled IPE for IPE incidence, causes, and actionability (reprogramming, system revision, medication changes) and event detection time. HM and CM patients were similar (mean age 63 years, 72% male, LVEF 29%, primary prevention 73%, DDD 57%). In the post-implant interval assessed (HM 100 ± 21.3 days vs. CM 101 ± 20.8 days, P = 0.54), 85.4% (776/908) HM patients and 87.7% CM (378/431) patients had no cause for IPE (P = 0.31). When IPE occurred, actionability in HM (64/177 [36.2%]) was greater versus CM (15/62 [24.2%], P = 0.12). Actionable items were discovered sooner with HM (P = 0.025). Device reprogramming or lead revision was triggered following 53/177 (29.9%) IPEs in HM versus 9/62 (14.5%) in CM (P = 0.018). Arrhythmia detection was enhanced by HM: 276 atrial and ventricular episodes were detected in 135 follow-ups in contrast to CM (65 episodes at 17 IPEs). More silent arrhythmic episodes were discovered by HM (7.2% vs. 1.5% [P = 0.15]). Since 27/42 (64.3%) IPEs driven by HM alerts were actionable, event notification was a valuable method for problem detection. Importantly, HM did not increase incidence of non-actionable IPEs (P = 0.72). Activation of automatic remote monitoring should be encouraged soon post-ICD implant. © 2015 Wiley Periodicals, Inc.

Comprehensive cardiac rehabilitation improves outcome for patients with implantable cardioverter defibrillator. Findings from the COPE-ICD randomised clinical trial.

PubMed

Berg, Selina Kikkenborg; Pedersen, Preben U; Zwisler, Ann-Dorthe; Winkel, Per; Gluud, Christian; Pedersen, Birthe D; Svendsen, Jesper H

2015-02-01

The aim of this randomised clinical trial was to assess a comprehensive cardiac rehabilitation intervention including exercise training and psycho-education vs 'treatment as usual' in patients treated with an implantable cardioverter defibrillator (ICD). In this study 196 patients with first time ICD implantation (mean age 57.2 (standard deviation (SD)=13.2); 79% men) were randomised (1:1) to comprehensive cardiac rehabilitation vs 'treatment as usual'. Altogether 144 participants completed the 12 month follow-up. The intervention consisted of twelve weeks of exercise training and one year of psycho-educational follow-up focusing on modifiable factors associated with poor outcomes. Two primary outcomes, general health score (Short Form-36 (SF-36)) and peak oxygen uptake (VO₂), were used. Post-hoc analyses included SF-36 and ICD therapy history. Comprehensive cardiac rehabilitation significantly increased VO2 uptake after exercise training to 23.0 (95% confidence interval (CI) 20.9-22.7) vs 20.8 (95% CI 18.9-22.7) ml/min/kg in the control group (p=0.004 (multiplicity p=0.015)). Comprehensive cardiac rehabilitation significantly increased general health; at three months (mean 62.8 (95% CI 58.1-67.5) vs 64.4 (95% CI: 59.6-69.2)) points; at six months (mean 66.7 (95% CI 61.5-72.0) vs 61.9 (95% CI 56.1-67.7) points); and 12 months (mean 63.5 (95% CI 57.7-69.3) vs 62.1 (95% CI 56.2-68.0)) points (p <0.05). Explorative analyses showed a significant difference between groups in favour of the intervention group. No significant difference was seen in ICD therapy history. Comprehensive cardiac rehabilitation combining exercise training and a psycho-educational intervention improves VO₂-uptake and general health. Furthermore, mental health seems improved. No significant difference was found in the number of ICD shocks or anti-tachycardia pacing therapy. © The European Society of Cardiology 2014.

Acute evaluation of transthoracic impedance vectors using ICD leads.

PubMed

Gottfridsson, Christer; Daum, Douglas; Kennergren, Charles; Ramuzat, Agnès; Willems, Roger; Edvardsson, Nils

2009-06-01

Minute ventilation (MV) has been proven to be very useful in rate responsive pacing. The aim of this study was to evaluate the feasibility of using implantable cardioverter-defibrillator (ICD) leads as part of the MV detection system. At implant in 10 patients, the transthoracic impedance was measured from tripolar ICD, tetrapolar ICD, and atrial lead vectors during normal, deep, and shallow voluntary respiration. MV and respiration rate (RespR) were simultaneously measured through a facemask with a pneumotachometer (Korr), and the correlations with impedance-based measurements were calculated. Air sensitivity was the change in impedance per change in respiratory tidal volume, ohms (Omega)/liter (L), and the signal-to-noise ratio (SNR) was the ratio of the respiratory and cardiac contraction components. The air sensitivity and SNR in tripolar ICD vector were 2.70 +/- 2.73 ohm/L and 2.19 +/- 1.31, respectively, and were not different from tetrapolar. The difference in RespR between tripolar ICD and Korr was 0.2 +/- 1.91 breaths/minute. The regressed correlation coefficient between impedance MV and Korr MV was 0.86 +/- 0.07 in tripolar ICD. The air sensitivity and SNR in tripolar and tetrapolar ICD lead vectors did not differ significantly and were in the range of the values in pacemaker leads currently used as MV sensors. The good correlations between impedance-based and Korr-based RespR and MV measurements imply that ICD leads may be used in MV sensor systems.

Current use of implantable electrical devices in Sweden: data from the Swedish pacemaker and implantable cardioverter-defibrillator registry.

PubMed

Gadler, Fredrik; Valzania, Cinzia; Linde, Cecilia

2015-01-01

The National Swedish Pacemaker and Implantable Cardioverter-Defibrillator (ICD) Registry collects prospective data on all pacemaker and ICD implants in Sweden. We aimed to report the 2012 findings of the Registry concerning electrical devices implantation rates and changes over time, 1 year complications, long-term device longevity and patient survival. Forty-four Swedish implanting centres continuously contribute implantation of pacemakers and ICDs to the Registry by direct data entry on a specific website. Clinical and technical information on 2012 first implants and postoperative complications were analysed and compared with previous years. Patient survival data were obtained from the Swedish population register database. In 2012, the mean pacemaker and ICD first implantation rates were 697 and 136 per million inhabitants, respectively. The number of cardiac resynchronization therapy (CRT) first implantations/million capita was 41 (CRT pacemakers) and 55 (CRT defibrillators), with only a slight increase in CRT-ICD rate compared with 2011. Most device implantations were performed in men. Complication rates for pacemaker and ICD procedures were 5.3 and 10.1% at 1 year, respectively. Device and lead longevity differed among manufacturers. Pacemaker patients were older at the time of first implant and had generally worse survival rate than ICD patients (63 vs. 82% after 5 years). Pacemaker and ICD implantation rates seem to have reached a level phase in Sweden. Implantable cardioverter-defibrillator and CRT implantation rates are very low and do not reflect guideline indications. Gender differences in CRT and ICD implantations are pronounced. Device and patient survival rates are variable, and should be considered when deciding device type. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

Reduction in depressive symptoms in primary prevention ICD scheduled patients - One year prospective study.

PubMed

Amiaz, Revital; Asher, Elad; Rozen, Guy; Czerniak, Efrat; Levi, Linda; Weiser, Mark; Glikson, Michael

2017-09-01

Implantable Cardioverter Defibrillators (ICDs), have previously been associated with the onset of depression and anxiety. The aim of this one-year prospective study was to evaluate the rate of new onset psychopathological symptoms after elective ICD implantation. A total of 158 consecutive outpatients who were scheduled for an elective ICD implantation were diagnosed and screened based on the Mini International Neuropsychiatric Interview (MINI). Depression and anxiety were evaluated using the Hamilton Rating Scales for Depression (HAM-D) and Anxiety (HAM-A). Patient's attitude toward the ICD device was evaluated using a Visual Analog Scale (VAS). Patients' mean age was 64±12.4years; 134 (85%) were men, with the majority of patients performing the procedure for reasons of 'primary prevention'. According to the MINI diagnosis at baseline, three (2%) patients suffered from major depressive disorder and ten (6%) from dysthymia. Significant improvement in HAM-D mean scores was found between baseline, three months and one year after implantation (6.50±6.4; 4.10±5.3 and 2.7±4.6, respectively F(2100)=16.42; p<0.001). There was a significantly more positive attitude toward the device over time based on the VAS score [F(2122)=53.31, p<0.001]. ICD implantation significantly contributes to the reduction of depressive symptoms, while the overall mindset toward the ICD device was positive and improved during the one-year follow-up. Copyright © 2017 Elsevier Inc. All rights reserved.

[Impact of attachment style, social support and the number of implantable cardioverter defibrillator (ICD) discharges on psychological strain of ICD patients].

PubMed

Simson, Udo; Perings, Christian; Plaskuda, Ariane; Schäfer, Ralf; Brehm, Michael; Bader, Doris; Tress, Wolfgang; Franz, Matthias

2006-12-01

OBJECTIVE It is well known fact, that the life of ICD patients is often affected by anxiety and depression. The number of ICD discharges is only a contributing factor explaining the variance of anxiety and depression. There have to be other factors that have more influence on the physical strain of ICD patients. In this study we examined the impact of attachment style and social support in addition to the number of ICD discharges. METHODS 119 out-patients at an out-patient ICD unit were examined consecutively with the following self report scales: (1) the State-Trait-Anxiety Inventory (STAI), (2) the Beck Depression Inventory (BDI), (3) a short form of a social support questionnaire (F-SOZU), (4) the Bielefeld Partnership Expectations Questionnaire (BFPE) and (5) a specifically designed questionnaire for the assessment of sociodemografic data. To determine the frequency and timing of the ICD discharges we analysed the ICD data. RESULTS 38 % of the ICD patients reported enhanced anxiety levels and 37 % reported enhanced depression levels. Only 38 % of the ICD patients received discharges at all. Elevated levels of anxiety and depression were found in patients who showed insecure attachment styles, low social support, long-term treatment in hospital and a higher number of ICD discharges. To explain the variance of anxiety we found social support, attachment style, and the number of ICD storms to be contributing factors. To explain the variance of depression we found social support and time spent in hospital in the previous year to be contributing factors. CONCLUSIONS Almost half of the ICD patients suffer considerably from anxiety and/or depression. These patients have to be identified and treated psychotherapeutically. Patients who show insecure attachment styles, receive low social support, undergo long-term treatment in hospital and receive a higher number of discharges, especially so called ICD storms, bear the highest risk to develop psychological strain

Heart failure severity, inappropriate ICD therapy, and novel ICD programming: a MADIT-RIT substudy.

PubMed

Daimee, Usama A; Vermilye, Katherine; Rosero, Spencer; Schuger, Claudio D; Daubert, James P; Zareba, Wojciech; McNitt, Scott; Polonsky, Bronislava; Moss, Arthur J; Kutyifa, Valentina

2017-12-01

The effects of heart failure (HF) severity on risk of inappropriate implantable cardioverter-defibrillator (ICD) therapy have not been thoroughly investigated. We aimed to study the association between HF severity and inappropriate ICD therapy in MADIT-RIT. MADIT-RIT randomized 1,500 patients to three ICD programming arms: conventional (Arm A), high-rate cut-off (Arm B: ≥200 beats/min), and delayed therapy (Arm C: 60-second delay for ≥170 beats/min). We evaluated the association between New York Heart Association (NYHA) class III (n = 256) versus class I-II (n = 251) and inappropriate ICD therapy in Arm A patients with ICD-only and cardiac resynchronization therapy with defibrillator (CRT-D). We additionally assessed benefit of novel ICD programming in Arms B and C versus Arm A by NYHA classification. In Arm A, the risk of inappropriate therapy was significantly higher in those with NYHA III versus NYHA I-II for both ICD (hazard ratio [HR] = 2.55, confidence interval [CI]: 1.51-4.30, P < 0.001) and CRT-D patients (HR = 3.73, CI: 1.14-12.23, P = 0.030). This was consistent for inappropriate ATP and inappropriate ICD therapy < 200 beats/min, but not for inappropriate shocks. Novel ICD programming significantly reduced inappropriate therapy in patients with both NYHA III (Arm B vs Arm A: HR = 0.08, P < 0.001; Arm C vs Arm A: HR = 0.17, P < 0.001) and NYHA I-II (Arm B vs Arm A: HR = 0.25, P < 0.001; Arm C vs Arm A: HR = 0.28, P < 0.001). Patients with more severe HF are at increased risk for inappropriate ICD therapy, particularly ATP due to arrhythmias < 200 beats/min. Novel programming with high-rate cut-off or delayed detection reduces inappropriate ICD therapies in both mild and moderate HF. © 2017 Wiley Periodicals, Inc.

The impact of remote monitoring of implanted cardioverter-defibrillator (ICD) and cardiac resynchronisation therapy device (CRT-D) patients on healthcare costs in the Silesian population: three-year follow-up.

PubMed

Buchta, Piotr; Tajstra, Mateusz; Kurek, Anna; Skrzypek, Michał; Świetlińska, Małgorzata; Gadula-Gacek, Elżbieta; Wasiak, Michał; Pyka, Łukasz; Gąsior, Mariusz

2017-01-01

The population of patients with implanted cardioverter-defibrillators (ICD) and cardiac resynchronisation therapy devices (CRT-D) is constantly growing. The use of remote-monitoring (RM) techniques in this group can significantly improve clinical outcomes, but there are limited data about the impact of RM on healthcare costs from a payer's perspective. The aim of the study was to assess the impact on costs for the healthcare system of RM in patients with ICD or CRT-D. We examined a cohort of 842 patients with ICD or CRT-D. The group was divided into two groups based on RM (or no RM [NRM]), matched according to important clinical characteristics. The subjects were followed for a maximum of three years after implantation (mean follow-up 2.11 ± 0.83 years). The overall costs for the healthcare provider in the follow-up were defined as the primary endpoint. The secondary endpoint was the use of different types of medical contact events: hospitalisation and number of in-clinic and general practitioner visits (without the number of remote transmissions). In the three-year follow-up, the reduction in the costs of treatment for National Health Care in the RM group was 33.5% (median value, p < 0.001). In patients with implanted CRT-D, the reduction reached 42.7% (p = 0.011), and with ICD it was 31.3% (p = 0.007). We observed no significant reduction in the median hospitalisation costs in the three-year follow-up in the RM group (p = NS), despite a 25% drop in the mean value. The costs of outpatient visits were slightly higher in the RM group (p = NS). In the follow-up period, there was no reduction in the number of medical contact events (p = NS). Remote monitoring in patients with implanted ICD or CRT-D devices reduces the cost for the national healthcare provider.

Early Implantation of Primary Prevention Implantable Cardioverter Defibrillators for Patients with Newly Diagnosed Severe Nonischemic Cardiomyopathy.

PubMed

Voskoboinik, Aleksandr; Bloom, Jason; Taylor, Andrew; Mariani, Justin

2016-09-01

Primary prevention implantable cardioverter defibrillators (ICDs) reduce mortality in selected patients with severe systolic dysfunction. Current guidelines suggest a 3- to 6-month waiting period before implantation. We retrospectively studied 29 consecutive patients with newly diagnosed nonischemic cardiomyopathy (NICM) who underwent primary prevention ICD implantation within 6 months of diagnosis between January 2008 and April 2014. Cardiac MRI (CMR) evaluated left ventricular ejection fraction (LVEF) and regional fibrosis preimplant. The primary end point was "failure to qualify for an ICD at 12 months postimplant," either due to LVEF ≥ 35% or deterioration necessitating mechanical support or transplantation, without appropriate ICD therapy. Secondary end points were appropriate and inappropriate ICD therapy. Baseline mean age was 44.2 ± 14.8 years and median LVEF 16.4%. Median time from diagnosis to implant was 32 days. At 12 months, 17 patients (58.6%) no longer qualified for an ICD, mainly due to LVEF improvement. At follow-up (mean 32.0 ± 20.6 months), three patients received appropriate therapy (one for ventricular fibrillation). All three had CMR late gadolinium enhancement (LGE) and nonsustained ventricular tachycardia (NSVT) preimplant. Cardiac resynchronization at implant predicted LVEF improvement. Early appropriate therapy, particularly for ventricular fibrillation, is infrequent for patients with very severe NICM who have ICDs implanted within 6 months of diagnosis. The majority of these patients would not qualify for an ICD at 12 months postinsertion. In the absence of a multimodality risk score, early ICD insertion should only be considered in selected cases (presence of LGE and NSVT). Wearable cardioverter defibrillators may have a role as a bridge to ICD decision. © 2016 Wiley Periodicals, Inc.

Implantation of subcutaneous implantable cardioverter defibrillators in Europe: results of the European Heart Rhythm Association survey.

PubMed

Boveda, Serge; Lenarczyk, Radoslaw; Haugaa, Kristina; Fumagalli, Stefano; Madrid, Antonio Hernandez; Defaye, Pascal; Broadhurst, Paul; Dagres, Nikolaos

2016-09-01

The purpose of this European Heart Rhythm Association (EHRA) survey is to provide an overview of the current use of subcutaneous cardioverter defibrillators (S-ICDs) across a broad range of European centres. A questionnaire was sent via the internet to centres participating in the EHRA electrophysiology research network. Questions included standards of care and policies used for patient management, indications, and techniques of implantation of the S-ICDs. In total, 52 centres replied to the questionnaire. More than one-fourth of the responding centres does not implant the S-ICD (n = 14, 27%). The majority reported to have implanted <10 (50%) or 10-29 (23%) S-ICDs during the last 12 months. Lack of reimbursement (25%), non-availability (19%), and cost of the device (25%) seem to limit the use of the S-ICD. The most commonly reported indications for S-ICD implantation are a difficult vascular access (82%), a history of previous complicated transvenous ICD (8O%), young age (69%), or an anticipated higher risk of infection (63%). Inappropriate therapies were the most frequently reported major problems (38%), but the majority of respondents (51%) never encountered any issue after an S-ICD implantation. Most of the respondents (83%) anticipate significant increase of S-ICD use within the next 2 years. This survey provides a contemporary insight into S-ICD implantation and management in the European electrophysiology centres, showing different approaches, depending on local policies. Cost issues or lack of reimbursement strongly influence the dissemination of the device. However, most respondents retain that S-ICD use will significantly increase in a very short time. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

Female-specific education, management, and lifestyle enhancement for implantable cardioverter defibrillator patients: the FEMALE-ICD study.

PubMed

Vazquez, Lauren D; Conti, Jamie B; Sears, Samuel F

2010-09-01

Significant rates of psychological distress occur in implantable cardioverter defibrillator (ICD) patients. Research has demonstrated that women are particularly at risk for developing distress and warrant psychosocial attention. The major objectives were to implement and test the effectiveness of a female-specific psychosocial group intervention on disease-specific quality of life outcomes in outpatient female ICD recipients versus a wait-list control group. Twenty-nine women were recruited for the study. Fourteen women were randomized to the intervention group and participated in a psychosocial intervention focused on female-specific issues; 15 were randomized to the wait-list control group. All women completed individual psychological batteries at baseline and at 1-month follow-up measuring shock anxiety and device acceptance. Pre-post measures of shock anxiety demonstrated a significant time by group interaction effect with the intervention group having a significantly greater decrease (Pillai's trace = 5.58, P = 0.026). A significant interaction effect (Pillai's trace = 5.05, P = 0.046) was found, such that women under the age of 50 experienced greater reduction in shock anxiety than their middle-aged cohorts. Pre-post measures of device acceptance revealed a significant time by group interaction effect with the intervention group having significantly greater increases (Pillai's trace = 5.80, P = 0.023). Structured interventions for female ICD patients involving ICD-specific education, cognitive behavioral therapy strategies, and group social support provide improvements in shock anxiety and device acceptance at 1-month re-assessment. Young women appear to be an at-risk subgroup of this population and may experience more benefit from psychosocial treatment targeting device-specific concerns. ©2010, The Authors. Journal compilation ©2010 Wiley Periodicals, Inc.

Insulation defects in Riata implantable cardioverter-defibrillator leads.

PubMed

Sato, Akinori; Chinushi, Masaomi; Iijima, Kenichi; Izumi, Daisuke; Furushima, Hiroshi

2012-01-01

The structures composing implantable cardioverter-defibrillator (ICD) leads have become more complicated and thinner with technological advances. Silicon insulation defects with and without clinically manifested electrical abnormalities have been reported in Riata leads (St. Jude Medical). The aim of this study was to assess the incidence and clinical implications of insulation defects in Riata leads implanted at our hospital. The subjects included 10 consecutive patients who received 8-French Riata ICD leads with dual-coil conductors (model 1580 or 1581) between 2006 and 2010 at our hospital. Operative records, chest X-rays and interrogation data were reviewed. In all cases, Atlas+ (St. Jude Medical) was used as an ICD generator and the Riata leads were implanted transvenously and fixed to the right ventricular apex. During a mean follow-up period of 52±9 (36-70) months, chest X-rays revealed insulation defects in Riata leads and conductor wires projecting from the bodies of the Riata leads in two of 10 (20%) patients. One of the patients received inappropriate ICD therapies due to T-wave oversensing based on attenuation of R waves and augmentation of T waves 41 months after implantation. In the other patient, an insulation defect without any clinically manifested electrical troubles was detected 50 months after implantation. Riata leads have a high incidence of insulation defects, which may be occasionally accompanied by inappropriate ICD discharges. For patients with Riata leads, careful observation of any changes in the lead-electrical measurements and a routine chest X-ray follow-up are necessary.

Medium voltage therapy for preventing and treating asystole and PEA in ICDs.

PubMed

Gilman, Byron L; Brewer, James E; Kroll, Kai; Kroll, Mark W

2009-01-01

Sudden cardiac death (SCD) takes up to 500,000 lives each year before a victim can even be treated. To address this the implantable cardioverter defibrillator (ICD) was developed to treat those identified at high risk of SCD. Unfortunately, there are a significant number of cases in which the ICD does not successfully return a victim to normal rhythm and effective perfusion of the blood. The vast majority of cases that are not responsive to the ICD therapy require cardio-pulmonary resuscitation (CPR) according to current resuscitation guidelines. A novel electrical stimulus called medium voltage therapy (MVT) has shown efficacy in producing coronary and carotid blood flow during ventricular fibrillation. This report presents the case that the same stimulus may be effective and feasible for use in ICD patients that do not respond to their ICD therapy, or do not have a rhythm in which, an ICD shock is indicated. The inclusion of MVT technology in implantable devices may be effective in preparing the heart for successful defibrillation or in improving the metabolic condition of the heart to the extent that a pulsatile rhythm may spontaneously develop.

Sensitivity and specificity of the subcutaneous implantable cardioverter defibrillator pre-implant screening tool.

PubMed

Zeb, Mehmood; Curzen, Nick; Allavatam, Venugopal; Wilson, David; Yue, Arthur; Roberts, Paul; Morgan, John

2015-09-15

The sensitivity and specificity of the subcutaneous implantable cardioverter defibrillator (S-ICD) pre-implant screening tool required clinical evaluation. Bipolar vectors were derived from electrodes positioned at locations similar to those employed for S-ICD sensing and pre-implant screening electrodes, and recordings collected through 80-electrode PRIME®-ECGs, in six different postures, from 40 subjects (10 healthy controls, and 30 patients with complex congenital heart disease (CCHD); 10 with Tetralogy of Fallot (TOF), 10 with single ventricle physiology (SVP), and 10 with transposition of great arteries (TGA)). The resulting vectors were analysed using the S-ICD pre-implant screening tool (Boston Scientific) and processed through the sensing algorithm of S-ICD (Boston Scientific). The data were then evaluated using 2 × 2 contingency tables. Fisher exact and McNemar tests were used for a comparison of the different categories of CCHD, and p < 0.05 vs. controls considered to be statistically significant. 57% of patients were male, mean age of 36.3 years. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the S-ICD screening tool were 95%, 79%, 59% and 98%, respectively, for controls, and 84%, 79%, 76% and 86%, respectively, in patients with CCHD (p = 0.0001). The S-ICD screening tool was comparatively more sensitive in normal controls but less specific in both CCHD patients and controls; a possible explanation for the reported high incidence of inappropriate S-ICD shocks. Thus, we propose a pre-implant screening device using the S-ICD sensing algorithm to minimise false exclusion and selection, and hence minimise potentially inappropriate shocks. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Physicians’ Knowledge and Attitudes Regarding Implantable Cardioverter- Defibrillators

PubMed Central

Sherazi, Saadia; Zareba, Wojciech; Daubert, James P.; McNitt, Scott; Shah, Abrar H.; Aktas, Mehmet K.; Block, Robert C.

2012-01-01

Background Information is limited regarding the knowledge and attitudes of physicians typically involved in the referral of patients for implantable cardioverter defibrillator (ICD) implantation. Methods We conducted a survey of primary care physicians and cardiologists at the University of Rochester Medical Center and the Unity Health System Rochester, NY from December 2008 to February 2009. The survey collected information regarding knowledge and attitudes of physicians towards ICD therapy. Results Of the 332 surveys distributed, 110 (33%) were returned. Over-all 94 (87%) physicians reported referring patients for ICD implantation. Eighteen (17%) physicians reported unawareness of guidelines for ICD use. Sixty-four (59%) physicians recommended ICD in patients with ischemic cardiomyopathy and left ventricular ejection fraction (LVEF) ≤ 35%. Sixty-five (62%) physicians use ≤ 35% as LVEF criteria for ICD referral in patients with non-ischemic cardiomyopathy. Cardiologists were more familiar than primary care physicians with LVEF criteria for implantation of ICD in patients with ischemic and non-ischemic cardiomyopathy (p value 0.005 and 0.002 respectively). Twenty-nine (27%) participants were unsure regarding benefits of ICDs in eligible women and Blacks. Eighty two (76%) physicians believed that an ICD could benefit patients ≥70 years whereas only 53 (49%) indicated that an ICD would benefit patients ≥ 80 years of age. A lack of familiarity with current clinical guidelines regarding ICD implantation exists. Primary care physicians are less aware of clinical guidelines than are cardiologists. This finding highlights the need to improve the dissemination of guidelines to primary care physicians in an effort to improve ICD utilization. PMID:20535717

[Inappropriate ICD therapies: All problems solved with MADIT-RIT?].

PubMed

Kolb, Christof

2015-06-01

The MADIT-RIT study represents a major trial in implantable cardioverter-defibrillator (ICD) therapy that was recently published. It highlights that different programming strategies (high rate cut-off or delayed therapy versus conventional) reduce inappropriate ICD therapies, leave syncope rates unaltered and can improve patient's survival. The study should motivate cardiologist and electrophysiologists to reconsider their individual programming strategies. However, as the study represents largely patients with ischemic or dilated cardiomyopathy for primary prevention of sudden cardiac death supplied with a dual chamber or cardiac resynchronisation therapy ICD, the results may not easily be transferable to other entities or other device types. Despite the success of the MADIT-RIT study efforts still need to be taken to further optimise device algorithms to avert inappropriate therapies. Optimised ICD therapy also includes the avoidance of unnecessary ICD shocks as well as the treatment of all aspects of the underlying cardiac disease.

Subcutaneous chronic implantable defibrillation systems in humans.

PubMed

Cappato, Riccardo; Smith, Warren M; Hood, Margaret A; Crozier, Ian G; Jordaens, Luc; Spitzer, Stefan G; Ardashev, Andrey V; Boersma, Lucas; Lupo, Pierpaolo; Grace, Andrew A; Bardy, Gust H

2012-09-01

The recent introduction of subcutaneous implantable cardioverter defibrillator (S-ICD) has raised attention about the potential of this technology for clinical use in daily clinical practice. We review the methods and results of the four studies conducted in humans for approval of this innovative technology for daily practice. Two studies using a temporary S-ICD system (acute human studies) were conducted to search for an appropriate lead configuration and energy requirements. For this purpose, 4 S-ICD configurations were tested in 78 patients at the time of transvenous (TV)-ICD implantation. The optimal configuration was tested in 49 more patients to comparatively assess the subcutaneous defibrillation threshold (S-DFT) versus the standard TV-ICD. Long-term implants were evaluated in 55 patients using an implanted system (chronic human study). The acute humans studies led to an optimal S-ICD configuration comprising a parasternal electrode and left anterolateral thoracic pulse generator. Both configurations successfully terminated 98% of induced ventricular fibrillation (VF), but significantly higher energy levels were required with S-ICD than with TV-ICD systems (36.6 ± 19.8 J vs. 11.1 ± 8.5 J). In the chronic study, all 137 VF episodes induced at time of implant were detected with a 98% conversion rate. Two pocket infections and four lead revisions were required during 10 ± 1 months of follow-up. During this period, survival was 98%, and 12 spontaneous ventricular tachyarrhythmias were detected and treated by the device. These data show that the S-ICD systems here consistently detected and converted VF induced at time of implant as well as sustained ventricular tachyarrhythmias occurring during follow-up (248).

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.

Wearable cardioverter defibrillator: a life vest till the life boat (ICD) arrives.

PubMed

Francis, Johnson; Reek, Sven

2014-01-01

It is well established that implantable cardioverter defibrillator (ICD) is a life saving device ensuring protection against life threatening ventricular arrhythmias. But there are certain situations like a recent myocardial infarction where the standard guidelines do not recommend the implantation of an ICD while the patient can still be at a risk of demise due to a life threatening ventricular arrhythmia. There could also be a temporary indication for protection while explanting an infected ICD system. The wearable cardioverter defibrillator (WCD) is a device which comes to the rescue in such situations. In this brief review, we discuss the historical aspects of the development of a WCD, technical aspects as well as the clinical trial data and real world scenario of its use. Copyright © 2013 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

Remote monitoring improves outcome after ICD implantation: the clinical efficacy in the management of heart failure (EFFECT) study.

PubMed

De Simone, Antonio; Leoni, Loira; Luzi, Mario; Amellone, Claudia; Stabile, Giuseppe; La Rocca, Vincenzo; Capucci, Alessandro; D'onofrio, Antonio; Ammendola, Ernesto; Accardi, Francesco; Valsecchi, Sergio; Buja, Gianfranco

2015-08-01

Internet-based remote interrogation systems have been shown to reduce emergency department and in-office visits in patients with implantable cardioverter defibrillators (ICDs), resulting in increased efficiency for healthcare providers. Nonetheless, studies sized to demonstrate the impact of remote monitoring on patients' outcome have been lacking. The EFFECT study was a multicentre clinical trial aimed at measuring and comparing the outcome of ICD patients conventionally followed-up by means of in-clinic visits (Standard arm) or by remote monitoring (Remote arm) in the clinical practice of 25 Italian centres. From 2011 to 2013, 987 consecutive patients were enrolled and followed up for at least 12 months. The primary endpoint was the rate of death and cardiovascular hospitalizations. Remote monitoring was adopted by 499 patients. Patients in the Standard and Remote arms did not differ significantly in terms of baseline clinical characteristics, except for a more frequent use of ICD with cardiac resynchronization therapy (CRT-D) in the Remote arm (48 vs. 36%, P < 0.001). One-year rates of the primary combined endpoint were 0.27 events/year for patients in the Standard arm and were 0.15 events/year for those in the Remote arm (incident rate ratio, 0.55; 95% CI, 0.41-0.73; P < 0.001). The endpoint rates in the Standard and Remote arms were 0.27 and 0.08 events/year, respectively, among CRT-D recipients (P < 0.001), and 0.28 vs. 0.21 among ICD patients (P = 0.094). The rates of in-office visits were 1.9 per year in the Standard arm and 1.7 per year in the Remote arm. Compared with the standard follow-up through in-office visits, remote monitoring is associated with reduced death and cardiovascular hospitalizations in patients with ICD in clinical practice. URL: http://clinicaltrials.gov/ Identifier: NCT01723865. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

Optimal programming management of ventricular tachycardia storm in ICD patients

PubMed Central

Qian, Zhiyong; Guo, Jianghong; Zhang, Zhiyong; Wang, Yao; Hou, Xiaofeng; Zou, Jiangang

2015-01-01

Abstract Ventricular tachycardia storm (VTS) is defined as a life-threatening syndrome of three or more separate episodes of ventricular tachycardia (VT) leading to implantable cardioverter defibrillator (ICD) therapy within 24 hours. Patients with VTS have poor outcomes and require immediate medical attention. ICD shocks have been shown to be associated with increased mortality in several studies. Optimal programming in minimization of ICD shocks may decrease mortality. Large controlled trials showed that long detection time and high heart rate detection threshold reduced ICD shock burden without an increase in syncope or death. As a fundamental therapy of ICD, antitachycardia pacing (ATP) can terminate most slow VT with a low risk of acceleration. For fast VT, burst pacing is more effective and less likely to result in acceleration than ramp pacing. One algorithm of optimal programming management during a VTS is presented in the review. PMID:25745473

Risk factors and prognostic role of an electrical storm in patients after myocardial infarction with an implanted ICD for secondary prevention.

PubMed

Kwaśniewski, Wojciech; Filipecki, Artur; Orszulak, Michał; Orszulak, Witold; Urbańczyk, Dagmara; Roczniok, Robert; Trusz-Gluza, Maria; Mizia-Stec, Katarzyna

2018-04-01

The aim of our study was to determine the risk factors for electrical storm (ES) and to assess the impact of ES on the long-term prognosis in patients after myocardial infarction (MI) with an implantable cardioverter-defibrillator (ICD) for secondary prevention of sudden cardiac death (SCD). We retrospectively analyzed 416 patients with coronary artery disease after MI who had an implanted ICD for secondary prevention of SCD. Fifty (12%) patients had one or more incidents of an electrical storm - the ES (+) group. We matched the reference group of 47 patients from 366 ES (-) patients. We analyzed 3,408 episodes of ventricular arrhythmias: 3,148 ventricular tachyarrhythmic episodes in the ES (+) group (including 187 episodes of ES) and 260 in the ES (-) group. Multivariate logistic regression showed that inferior wall MI (RR = 3.98, 95% CI: 1.52-10.41) and the absence of coronary revascularization (RR = 2.92, 95% CI: 1.18-7.21) were independent predictors of ES ( p = 0.0014). During 6-year observation of 97 patients, there were 39 (40%) deaths: 25 (50%) subjects in the ES (+) group and 14 (30%) in the ES (-) group ( p = 0.036). Independent predictors of death were: the occurrence of ES (HR = 1.93), older age (HR = 1.06), and lower left ventricular ejection fraction (HR = 0.95) (for all p < 0.001). Electrical storm in patients after MI with ICD for secondary prevention is a relatively common phenomenon and has a negative prognostic significance. Myocardial infarction of the inferior wall and the absence of coronary revascularization are predisposing factors for the occurrence of an ES.

Psychological adaptation to ICDs and the influence of anxiety sensitivity.

PubMed

Lemon, Jim; Edelman, Sarah

2007-03-01

Forty-nine patients scheduled for implantable cardioverter defibrillator (ICD) implantation completed self-report psychological questionnaires prior to surgery and at 2, 4 and 6 months after surgery. The most common psychological problem identified was anxiety, with clinically significant cases based on the Depression Anxiety and Stress Scale (DASS) ranging between 26% and 34%. Clinically significant depression ranged between 8% and 20%. Anxiety sensitivity was associated with high levels of anxiety, depression and stress at baseline, but not at follow-up assessments. It is possible that within this population anxiety sensitivity is associated with distress during high-threat situations, but the relationship diminishes once the threat has passed. In addition, the reassurance provided by the ICD may reduce negative perceptions of symptoms, promoting psychological adaptation.

Right versus left parasternal electrode position in the entirely subcutaneous ICD.

PubMed

Bettin, Markus; Dechering, Dirk; Frommeyer, Gerrit; Larbig, Robert; Löher, Andreas; Reinke, Florian; Köbe, Julia; Eckardt, Lars

2018-05-01

The subcutaneous implantable cardioverter defibrillator (S-ICD ® ) has been established as an alternative to conventional transvenous ICD for the prevention of sudden cardiac death. Initial studies have shown safety and efficacy of the system with a left parasternal (LP) electrode. However, several case studies reported a right parasternal (RP) position. The purpose of this study was to analyze shock efficacy and safety of an RP electrode position. Between June 2010 and May 2016, 120 S-ICD ® were implanted at our institution. On the basis of the heart location on preoperative chest radiography (CXR), the investigators decided on an RP (n = 52) or LP electrode position (n = 68). All perioperative induced VF episodes, and spontaneous appropriate and inappropriate episodes during follow-up were analyzed. Patients with an RP electrode did not differ in terms of age, sex, or ejection fraction. A statistically significant difference in underlying cardiac disease was observed between the RP and LP electrode group, with more patients with channelopathies in the RP electrode group and more patients with non-ischemic cardiomyopathy in the LP electrode group. During a mean follow-up of 24.3 ± 19.5 months, 27 appropriate (19 in the LP group and 8 in the RP group) and 28 inappropriate (18 LP and 10 RP) ICD shocks occurred (p value = NS). In the present study, an RP electrode position was chosen on the basis of chest radiographic characteristics and was efficient in terms of sensing and shock efficacy. Thus, a right-sided electrode implant might be an alternative if a left-sided electrode implant is inadequate. It might also be favorable for young patients with narrow heart silhouettes in the midsagittal position.

The Use of Advance Directives Among Patients With Implantable Cardioverter Defibrillators

PubMed Central

Tajouri, Tanya H.; Ottenberg, Abigale L.; Hayes, David L.; Mueller, Paul S.

2013-01-01

Background We aimed to determine the prevalence of advance directives (ADs) among patients with implantable cardioverter defibrillators (ICDs) and of ADs that addressed ICD management at the end of life. Methods The medical records of all patients who underwent ICD implantation during 2007 at a single institution were reviewed retrospectively to determine the number of patients with an AD and the number of ADs mentioning the ICD specifically (ie, ICD management at end of life). Results During 2007, 420 patients (males, 71%) underwent ICD implantation at our institution (mean age [range] at implantation, 63 [1–90] years). Primary prevention was the most common indication for device therapy (254 patients [61%]). Overall, 127 patients (30%) had an AD, with 83 ADs (65%) completed more than 12 months before ICD implantation and 10 (8%) completed after it. Several life-sustaining treatments were mentioned in the ADs: tube feeding, 46 (37%); cardiopulmonary resuscitation, 25 (20%); mechanical ventilation, 22 (17%); and hemodialysis, 9 (7%). Pain control was mentioned in 58 ADs (46%) and comfort measures in 38 (30%). However, only 2 ADs (2%) mentioned the ICD or its deactivation at end of life. Conclusions About one-third of patients with ICDs had an AD, but only a couple ADs mentioned the ICD. These results suggest that clinicians should not only encourage patients with ICDs to complete an AD, but also encourage them to address ICD management specifically. Not addressing ICD management in an AD may result in ethical dilemmas during end-of- life care. PMID:22432897

The relationship between baseline and follow-up left ventricular ejection fraction with adverse events among primary prevention ICD patients.

PubMed

Friedman, Daniel J; Fudim, Marat; Overton, Robert; Shaw, Linda K; Patel, Divyang; Pokorney, Sean D; Velazquez, Eric J; Al-Khatib, Sana M

2018-07-01

Left ventricular ejection fraction (LVEF) is used to select patients for primary prevention implantable cardioverter defibrillators (ICDs). The relationship between baseline and long-term follow-up LVEF and clinical outcomes among primary prevention ICD patients remains unclear. We studied 195 patients with a baseline LVEF ≤35% ≤6 months prior to ICD implantation and follow-up LVEF 1-3 years after ICD implantation without intervening left ventricular assist device (LVAD) or transplant. The co-primary study endpoints were: (1) a composite of time to death, LVAD, or transplant and (2) appropriate ICD therapy. We examined multivariable Cox proportional hazard models with a 3-year post-implant landmark view; the LVEF closest to the 3-year mark was considered the follow-up LVEF for analyses. Follow-up LVEF was examined using 2 definitions: (1) ≥10% improvement compared to baseline or (2) actual value of ≥40%. Fifty patients (26%) had a LVEF improvement of ≥10% and 44 (23%) had a follow-up LVEF ≥40%. Neither baseline nor follow-up LVEF was significantly associated with the composite endpoint. In contrast, both baseline and follow-up LVEF were associated with risk for long-term ICD therapies, whether follow-up LVEF was modeled as a ≥10% absolute improvement (baseline LVEF HR 0.87, CI 0.91-0.93, P < .001; follow-up LVEF HR 0.18, CI 0.06-0.53, P = .002) or a ≥40% follow-up value (baseline LVEF HR 0.89, CI 0.83-0.96, P = .001, follow-up LVEF HR 0.26, CI 0.08-0.87, P = .03). Among primary prevention ICD recipients, both baseline and follow-up LVEF were independently associated with long-term risk for appropriate ICD therapy, but they were not associated with time to the composite of LVAD, transplant, or death. Copyright © 2018 Elsevier Inc. All rights reserved.

Patient satisfaction and suggestions for improvement of remote ICD monitoring.

PubMed

Petersen, Helen Høgh; Larsen, Mie Christa Jensen; Nielsen, Olav Wendelboe; Kensing, Finn; Svendsen, Jesper Hastrup

2012-09-01

The study aim was to evaluate patient acceptance and content with remote follow-up (FU) of their implantable cardioverter defibrillator (ICD) and to estimate patients' wish for changes in remote follow-up routines. Four hundred seventy-four ICD patients at the device follow-up clinic at Rigshospitalet using CareLink® (Medtronic) remote follow-up, who had made ≥2 transmissions, received a questionnaire. Three hundred eighty-five patients (81.2%) answered. Mean time with ICD was 56 ± 45 months and mean age was 62 ± 13 years; 80% was male. Diagnosis related to ICD implant was: ischemic heart disease in 56% and dilated cardiomyopathy in 21%. Twenty-six percent had primary prophylactic indication. Mean time on remote FU was 16.4 ± 6.9 months. Mean time spent on in-clinic FU (two-way transport and FU) was 4 h and 36 min ± 7 h and 50 min, excluding 12 patients from Greenland and Faroe Islands. Ninety-five percent of the patients was very content or content with remote FU compared to in-clinic FU; 3% was less content and 2% was not content. For scheduled transmissions, 21% of the patients wished for a faster reply (sms or e-mail) compared to current practice with a letter. Eighty-four percent preferred more detailed information concerning ICD leads, battery status, and ICD therapies. A total of 96 patients (25%) had performed extra unscheduled remote transmissions: 20 due to shock, 20 due to alarm, 35 due to palpitations, and 18 for other or combined reasons. Ninety-five percent of the patients were content with the remote FU. Only 25% had unscheduled transmissions and most unscheduled transmissions were for appropriate reasons. Eighty-four percent of the patients wished for a more detailed response and 21% wished for a faster reply after routine transmissions.

Case-control study of surgical site infections associated with pacemakers and implantable cardioverter-defibrillators.

PubMed

Marschall, Jonas; Hopkins-Broyles, Diane; Jones, Marilyn; Fraser, Victoria J; Warren, David K

2007-11-01

In 2000, the rate of surgical site infections (SSIs) associated with pacemaker and implantable cardioverter-defibrillator (ICD) procedures performed in the cardiothoracic operating rooms of hospital A was 16% (19 of 116 procedures resulted in infections). This study investigates risks for SSI associated with these procedures in the cardiothoracic operating room. Unmatched 1 : 3 case-control study performed over a 12-month period among patients who had undergone implantation of a pacemaker and/or ICD. A standardized observation scrutinized infection control practices in the area where the procedures were performed. The cardiothoracic operating rooms of hospital A, which belongs to a hospital consortium in the midwestern United States. Patients with SSI were identified as case patients. Control patients were chosen from the group of uninfected patients who had procedures performed during the same period as case patients. A total of 19 SSIs associated with pacemaker and ICD procedures were retrospectively identified among the patients who underwent procedures in these cardiothoracic operating rooms. Culture samples were obtained from 7 patients; 2 yielded coagulase-negative Staphylococcus on culture, 2 yielded Staphylococcus aureus, 1 yielded Serratia marcescens, and 2 showed no growth. In the case-control study, age, race, sex, diabetes mellitus, smoking history, timing of antibiotic therapy, and hair removal did not differ significantly between case patients and control patients. Case patients were more likely to have an abdominal device in place (odds ratio [OR], 5.5 [95% confidence interval {CI}, 1.6-19.3]; P=.006) and less likely to have received a new implant (OR 0.3 [95% CI, 0.1-0.8]; P=.02) or to have had new leads placed (OR, 0.2 [95% CI, 0.1-0.6]; P=.003). Abdominal placement of implanted devices was associated with occurrence of an SSI after pacemaker and/or ICD procedures.

Radiofrequency ablation of fast ventricular tachycardia causing an ICD storm in an infant with hypertrophic cardiomyopathy.

PubMed

Ergul, Yakup; Ozyilmaz, Isa; Bilici, Meki; Ozturk, Erkut; Haydin, Sertaç; Guzeltas, Alper

2018-04-01

An implantable cardioverter defibrillator (ICD) storm involves very frequent arrhythmia episodes and ICD shocks, and it is associated with poor short-term and long-term prognosis. Radiofrequency catheter ablation can be used as an effective rescue treatment for patients with an ICD storm. To our knowledge, this is the first report of an infant with hypertrophic cardiomyopathy presenting with an ICD storm and undergoing successful radiofrequency catheter ablation salvage treatment for the fast left posterior fascicular ventricular tachycardia. © 2017 Wiley Periodicals, Inc.

Inappropriate shock and battery switching to "End of Life" in a patient with biventricular ICD during magnetic resonance imaging.

PubMed

Atar, İlyas; Bal, Uğur; Ertan, Çağatay; Özin, Bülent; Müderrisoğlu, Haldun

2016-01-01

Presence of a cardiac pacemaker or implantable cardioverter defibrillator (ICD) is a relative contraindication to magnetic resonance imaging (MRI). Biventricular ICDs are often used in the treatment of advanced heart failure; however, reports on experience with biventricular ICDs are lacking in the literature. In this case report, we describe a pacemaker-dependent patient with a biventricular ICD on whom an MRI of the lumbar spine was performed without having realized the presence of the ICD.

Feasibility of early discharge after implantable cardioverter-defibrillator procedures.

PubMed

Choudhuri, Indrajit; Desai, Dipan; Walburg, Jon; August, Phyllis; Keller, Seth I; Suri, Ranjit

2012-10-01

Registry data demonstrate considerably low complication rates after implantable cardioverter-defibrillator (ICD) procedures for primary prevention of sudden death. Yet standard of care includes postimplant overnight in-hospital observation that may levy substantial unnecessary financial burden on health care systems. In appropriate patients, discharge soon after implant could translate into significant cost savings, if such practice does not result in complications. We applied a simple clinical algorithm to assess feasibility of discharge on the same day of ICD implantation in patients at low risk for procedural complications. We prospectively randomized primary prevention ICD candidates at low risk for complications (not pacing-dependent or requiring bridging heparin anticoagulation) to next-day discharge with overnight in-hospital observation, or same-day discharge with remote monitoring for 24 hours after ICD implant. Implants were performed via cephalic vein access, and randomization occurred after 4-hours clinical observation and device interrogation. All patients were followed for a minimum of 6 weeks to assess acute procedural complications. 71 patients comprised the study cohort (mean age 62, 79% male) after 3 were excluded. The most common indication for ICD implant was ischemic cardiomyopathy with ejection fraction ≤35%. Device data obtained through 24-hour remote monitoring was comparable to 4-hour postimplant parameters in same-day discharge patients. No acute complications occurred in same-day discharge patients; 1 next-day discharge patient developed pneumothorax. ICD implantation with same-day discharge is reasonable in patients at low risk for complications. Remote monitoring can be useful in indicating lead-parameter stability during the immediate postoperative period. © 2012 Wiley Periodicals, Inc.

Conventional and right-sided screening for subcutaneous ICD in a population with congenital heart disease at high risk of sudden cardiac death.

PubMed

Alonso, Pau; Osca, Joaquín; Rueda, Joaquín; Cano, Oscar; Pimenta, Pedro; Andres, Ana; Sancho, María José; Martinez, Luis

2017-11-01

Information regarding suitability for subcutaneous defibrillator (sICD) implantation in tetralogy of Fallot (ToF) and systemic right ventricle is scarce and needs to be further explored. The main objective of our study was to determine the proportion of patients with ToF and systemic right ventricle eligible for sICD with both, standard and right-sided screening methods. Secondary objectives were: (i) to study sICD eligibility specifically in patients at high risk of sudden cardiac death, (ii) to identify independent predictors for sICD eligibility, and (iii) to compare the proportion of eligible patients in a nonselected ICD population. We recruited 102 patients with ToF, 33 with systemic right ventricle, and 40 consecutive nonselected patients. Conventional electrocardiographic screening was performed as usual. Right-sided alternative screening was studied by positioning the left-arm and right-arm electrodes 1 cm right lateral of the xiphoid midline. The Boston Scientific ECG screening tool was utilized. In high-risk patients with ToF, eligibility was higher with right-sided screening in comparison with standard screening (61% vs. 44%; p = .018). Eligibility in high-risk right ventricle population was identical with both screening methods (77%, p = ns). The only independent predictor for sICD eligibility was QRS duration. In high-risk patients with ToF, right-sided implantation of the sICD could be an alternative to a conventional ICD. In patients with a systemic right ventricle, implantation of a sICD is an alternative to a conventional sICD. © 2017 Wiley Periodicals, Inc.

Educational videos to reduce racial disparities in ICD therapy via innovative designs (VIVID): a randomized clinical trial.

PubMed

Thomas, Kevin L; Zimmer, Louise O; Dai, David; Al-Khatib, Sana M; Allen LaPointe, Nancy M; Peterson, Eric D

2013-07-01

Black individuals eligible for an implantable cardioverter/defibrillator (ICD) are considerably less likely than white individuals to receive one. This disparity may, in part, be explained by racial differences in patient preferences. We hypothesized that a targeted patient-centered educational video could improve knowledge of sudden cardiac arrest (SCA) and ICDs and reduce racial differences in ICD preferences. We conducted a pilot study to assess the feasibility of testing this hypothesis in a randomized trial. We created a video that included animation, physician commentary, and patient testimonials on SCA and ICDs. The primary outcome was the decision to have an ICD implanted as a function of race and intervention. Between January 1, 2011, and December 31, 2011, 59 patients (37 white and 22 black) were randomized to the video or health care provider counseling/usual care. Relative to white patients, black patients were younger (median age, 55 vs 68 years) and more likely to have attended college or technical school. Baseline SCA and ICD knowledge was similar and improved significantly in both racial groups after the intervention. Black patients viewing the video were as likely as white patients to want an ICD (60.0% vs 79.2%, P = .20); and among those in the usual care arm, black patients were less likely than white patients to want an ICD (42.9% vs 84.6% P = .05). Among individuals eligible for an ICD, a video decision aid increased patient knowledge and reduced racial differences in patient preference for an ICD. Copyright © 2013 Mosby, Inc. All rights reserved.

Low risk of electromagnetic interference between smartphones and contemporary implantable cardioverter defibrillators.

PubMed

Burri, Haran; Mondouagne Engkolo, Louis Paulin; Dayal, Nicolas; Etemadi, Abdul; Makhlouf, Anne-Marie; Stettler, Carine; Trentaz, Florence

2016-05-01

Manufacturers of implantable cardioverter defibrillators (ICDs) recommend that cell phones be maintained at a distance of ∼15 cm from the implanted device in order to avoid risk of dysfunction due to electromagnetic interference (EMI). Data relating to this issue are outdated and do not reflect modern technology. Our aim was to evaluate whether EMI is still an issue with contemporary ICDs and smartphones. Consecutive patients implanted with a wireless-enabled ICD were tested for potential interference with two models of recent 4G smartphones in conditions intended to maximize risk of EMI. A magnet effect (due to the phone speakers) was tested by placing the smartphones in the standby mode directly over the ICD generator. The presence of EMI artefacts on the real-time electrograms was evaluated by placing the smartphones in the standby, dialling, and operating modes directly over the generator casing and over the parasternal region in the vicinity of the ventricular lead. A total of 63 patients equipped with 29 different models of single, dual, or biventricular ICDs from five major manufacturers were included. None of the patients showed any evidence of interference with the smartphones during any of the 882 tests. The risk of EMI between modern smartphones and contemporary ICDs is low. This is probably due to the filters incorporated in the ICDs and low emission by the phones, as well as the small size of the magnets in the smartphones tested. NCT02330900 (http://www.clinicaltrials.gov). Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

Postmortem ICD interrogation in mode of death classification.

PubMed

Nikolaidou, Theodora; Johnson, Miriam J; Ghosh, Justin M; Marincowitz, Carl; Shah, Saumil; Lammiman, Michael J; Schilling, Richard J; Clark, Andrew L

2018-04-01

The definition of sudden death due to arrhythmia relies on the time interval between onset of symptoms and death. However, not all sudden deaths are due to arrhythmia. In patients with an implantable cardioverter defibrillator (ICD), postmortem device interrogation may help better distinguish the mode of death compared to a time-based definition alone. This study aims to assess the proportion of "sudden" cardiac deaths in patients with an ICD that have confirmed arrhythmia. We conducted a literature search for studies using postmortem ICD interrogation and a time-based classification of the mode of death. A modified QUADAS-2 checklist was used to assess risk of bias in individual studies. Outcome data were pooled where sufficient data were available. Our search identified 22 studies undertaken between 1982 and 2015 with 23,600 participants. The pooled results (excluding studies with high risk of bias) suggest that ventricular arrhythmias are present at the time of death in 76% of "sudden" deaths (95% confidence interval [CI] 67-85; range 42-88). Postmortem ICD interrogation identifies 24% of "sudden" deaths to be nonarrhythmic. Postmortem device interrogation should be considered in all cases of unexplained sudden cardiac death. © 2018 Wiley Periodicals, Inc.

Safety of mid-septal electrode placement in implantable cardioverter defibrillator recipients--results of the SPICE (Septal Positioning of ventricular ICD Electrodes) study.

PubMed

Kolb, Christof; Solzbach, Ulrich; Biermann, Jürgen; Semmler, Verena; Kloppe, Axel; Klein, Norbert; Lennerz, Carsten; Szendey, Istvan; Andrikopoulos, George; Tzeis, Stylianos; Asbach, Stefan

2014-07-01

Detrimental effects of right ventricular (RV) apical pacing have directed the interest toward alternative pacing sites such as the RV mid-septum. As safety data are scarce for implantable cardioverter defibrillator (ICD) recipients the study aims to evaluate ICD lead performance in the mid-septal position. A total of 299 ICD recipients (79% male, aged 65.2 ± 12.1 years, 83% primary prevention of sudden cardiac death) were randomized to receive the RV ICD electrode either in a mid-septal (n=145) or apical (n=154) location. Event-free survival was evaluated at 3 (primary endpoint) and 12 months (secondary endpoint). Events included a composite of lead revision, suboptimal right ventricular electrode performance (including defibrillation thresholds (DFT)>25 J) or lead position not in accordance with randomized location. Event-free survival at 3 (12) months was observed in 80.6% (72.3%) of patients randomized to a mid-septal and in 82.2% (72.1%) of patients randomized to an apical lead position, p=0.726 (p=0.969). Pre-defined margins for non-inferiority were not reached at 3 or 12 months. High DFT was found in 7 patients (5.0%) of the mid-septal and in 3 (2.2%) patients of the apical group (p=0.209). In ICD recipients electrode positioning to the RV mid-septum or the RV apex results in slightly different rates concerning the survival free of lead revision, suboptimal right ventricular electrode performance or non-randomized lead position. Non-inferiority of the mid-septal lead location cannot be concluded. This should be taken into consideration when a mid-septal lead position is pursued. ClinicalTrials.gov identifier NCT00745745. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

ICD defibrillation failure solved in an unusual fashion.

PubMed

Oliveira, Ricardo Gil; Madeira, Francisco; Ferreira, Ana Rita; Antunes, Susana; Morais, Carlos; Gil, Victor

2010-04-01

An implantable cardioverter defibrillator (ICD) is designed to sense life-threatening ventricular arrhythmias and terminate them, either by rapid pacing or by delivering an electrical shock. Nowadays it is a proven therapy for both primary and secondary prevention of sudden cardiac death. The typical configuration of an ICD consists of a right ventricular sensing/defibrillator lead with two coils (one distal, located in the right ventricle, and one proximal, located at the superior vena cava-right atrium junction) and an active can, the so-called "ventricular triad". Although effective in the vast majority of patients, it could be argued that this is not the most rational arrangement in electrical terms, since the main shock vector is anteriorly displaced in relation to the greater portion of the left ventricular mass. We describe a case of an ICD defibrillation failure that was solved by placing an additional defibrillator lead in a tributary of the coronary sinus.

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

PubMed

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

2012-08-01

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

Decision-Making Experiences of Patients with Implantable Cardioverter Defibrillators.

PubMed

Green, Ariel R; Jenkins, Amy; Masoudi, Frederick A; Magid, David J; Kutner, Jean S; Leff, Bruce; Matlock, Daniel D

2016-10-01

When patients are not adequately engaged in decision making, they may be at risk of decision regret. Our objective was to explore patients' perceptions of their decision-making experiences related to implantable cardioverter defibrillators (ICDs). Cross-sectional, mailed survey of 412 patients who received an ICD without cardiac resynchronization therapy for any indication between 2006 and 2009. Patients were asked about decision participation and decision regret. A total of 295 patients with ICDs responded (72% response rate). Overall, 79% reported that they were as involved in the decision as they wanted. However, 28% reported that they were not told of the option of not getting an ICD and 37% did not remember being asked if they wanted an ICD. In total, 19% reported not wanting their ICD at the time of implantation. Those who did not want the ICD were younger (<65 years; 74% vs 43%, P < 0.001), had higher decision regret (31/100 vs 11/100, P < 0.001), and reported less participation in decision making (the doctor "totally" made the decision, 9% vs 3%; P < 0.001). A considerable number of ICD recipients recalled not wanting their ICD at the time of implantation. While these findings may be prone to recall bias, they likely identify opportunities to improve ICD decision making. © 2016 Wiley Periodicals, Inc.

Pacemakers and implantable cardioverter-defibrillators in pediatric patients.

PubMed

Silka, Michael J; Bar-Cohen, Yaniv

2006-11-01

The use of pacemakers and implantable cardioverter-defibrillators (ICDs) in infants, children, and patients with congenital heart disease presents unique challenges and considerations. They include uncommon indications for device implantation, innovative approaches to lead implantation and configuration, and age-dependent and disease-specific aspects of device programming. In this review, the current indications for pacemaker and ICD implantation in young patients are discussed, followed by consideration of the approaches to lead and device placement in very small patients and those with complex congenital heart disease, in whom unique problems may be encountered. The limitations of programmability of current pacemakers and ICDs when used in young patients are discussed, followed by an analysis of long-term device follow-up and potential late complications.

Long-term follow-up of implantable cardioverter-defibrillators in adult congenital heart disease patients: indications and outcomes.

PubMed

Santharam, Sandhya; Hudsmith, Lucy; Thorne, Sara; Clift, Paul; Marshall, Howard; De Bono, Joseph

2017-03-01

Ventricular arrhythmias are a major cause of mortality in adult congenital heart disease (ACHD) patients. The European Society of Cardiology guidelines state that implantable cardioverter-defibrillators (ICD) should be considered in patients with congenital heart disease following spontaneous sustained ventricular tachycardia (VT) or cardiac arrest and in patients at presumed high risk. This study sought to analyse the circumstances in which ACHD patients received ICD and to assess outcomes of ICD implantation, including therapies delivered and the rate of complications. A retrospective review was performed of all adult patients with congenital heart disease undergoing ICD implant between 2000 and 2014, in a large quaternary referral centre with over 4000 adults with congenital heart disease under active follow-up. Demographics: 42 patients with congenital heart disease had ICD implants: 55% male; age range 21-71 years and mean age 45 years. Mean age at implantation of ICD was 41 years. Mean follow-up was 5 years. Diagnosis: 50% of patients had repaired tetralogy of Fallot (TOF). Twelve per cent of patients had repaired transposition of the great arteries. Reason for ICD: 15 patients (35.7%) received ICD after sustained VT. Eleven patients (26.2%) received ICD after cardiac arrest. Sixteen (38%) had ICD implanted as primary prophylaxis. Outcome: Since implantation, six patients received an appropriate full-output shock for VT from ICD. Nineteen (45%) patients suffered significant complications (inappropriate shocks 11, inappropriate anti-tachycardia pacing resulting in VF 1, infection requiring extraction 3, lead abnormalities 3, and pneumothorax 1). Equal proportions of primary and secondary prevention patients received appropriate shocks. Most patients had ICD for secondary prevention (62%), and the majority had repaired TOF. There was a 2.9% annual appropriate shock rate. However, there was a high incidence of complications with more than a third suffering a

Questions to Ask Your Doctor--Implantable Cardioverter Defibrillator (ICD)

MedlinePlus

... affect my family member or me because of gender? Does age have any bearing on how the ICD works? Does one kind of therapy ... brief, easy to follow and easy to read. Many topics also available in Spanish . ... 4 Warning Signs of a Heart Attack 5 How to Eat Healthy 6 What are the Symptoms ...

Optimal Implantable Cardioverter Defibrillator Programming.

PubMed

Shah, Bindi K

Optimal programming of implantable cardioverter defibrillators (ICDs) is essential to appropriately treat ventricular tachyarrhythmias and to avoid unnecessary and inappropriate shocks. There have been a series of large clinical trials evaluating tailored programming of ICDs. We reviewed the clinical trials evaluating ICD therapies and detection, and the consensus statement on ICD programming. In doing so, we found that prolonged ICD detection times, higher rate cutoffs, and antitachycardia pacing (ATP) programming decreases inappropriate and painful therapies in a primary prevention population. The use of supraventricular tachyarrhythmia discriminators can also decrease inappropriate shocks. Tailored ICD programming using the knowledge gained from recent ICD trials can decrease inappropriate and unnecessary ICD therapies and decrease mortality.

ICD-10: from assessment to remediation to strategic opportunity.

PubMed

Dugan, John K

2012-02-01

Healthcare finance teams should perform an enterprisewide assessment to determine what ICD-10 means to their organization, strategically, operationally, and financially. CFOs should strategically evaluate the impact of ICD-10 on the organization's entire financial operation. Organizations should have a contingency plan in place across all processes.

Electromagnetic interference of dental equipment with implantable cardioverter defibrillators.

PubMed

Dadalti, Manoela Teixeira de Sant'Anna; da Cunha, Antônio José Ledo Alves; Araújo, Marcos César Pimenta de; Moraes, Luis Gustavo Belo de; Risso, Patrícia de Andrade

2017-11-01

Implantable cardioverter defibrillators (ICDs) are subject to electromagnetic interference (EMI). The aim of this study was to assess both the EMI of dental equipments with ICDs and related factors. High- and low-speed handpieces, an electric toothbrush, an implant motor and two types of ultrasonic devices were tested next to an ICD with different sensitivity settings. The ICD was immersed in a saline solution with electrical resistance of 400-800 ohms to simulate the resistance of the human body. The dental equipments were tested in both horizontal (0°) and vertical (90°) positions in relation to the components of the ICD. The tests were performed with a container containing saline solution, which was placed on a dental chair in order to assess the cumulative effect of electromagnetic fields. The dental chair, high- and low-speed handpieces, electric toothbrush, implant motor and ultrasonic devices caused no EMI with the ICD, irrespective of the program set-up or positioning. No cumulative effect of electromagnetic fields was verified. The results of this study suggest that the devices tested are safe for use in patients with an ICD.

Subcutaneous Implantable Cardioverter Defibrillator in Patients With Hypertrophic Cardiomyopathy: An Initial Experience.

PubMed

Weinstock, Jonathan; Bader, Yousef H; Maron, Martin S; Rowin, Ethan J; Link, Mark S

2016-02-12

The subcutaneous implantable cardioverter defibrillator (S-ICD) has been developed to avert risks associated with transvenous defibrillator leads. The technology is attractive for younger patients, such as those with hypertrophic cardiomyopathy (HCM). However, there are limited data on S-ICD use in HCM. HCM patients identified at risk for sudden death were considered for S-ICD implantation. Patients were screened for potential oversensing by surface electrocardiography (ECG). At implant, defibrillation threshold (DFT) testing was performed at 65, 50, and 35 joules (J). Twenty-seven patients were considered for S-ICD implantation, and after screening, 23 (85%) remained eligible. The presence of a bundle branch block was associated with screening failure, whereas elevated body mass index (BMI) showed a trend toward association. One patient passed screening at rest, but failed with an ECG obtained after exercise. At implant, the S-ICD terminated ventricular fibrillation (VF) with a 65J shock in all 15 implanted patients and a 50J shock was successful in 12 of 15. A 35J shock terminated VF in 10 of 12 patients. DFT failure at 50 J was associated with a higher BMI. There were no appropriate shocks after a median follow-up of 17.5 (3-35) months, and 1 patient received an inappropriate shock attributable to a temporary reduction in QRS amplitude while bending forward, resulting in oversensing, despite successful screening. In a high-risk HCM cohort without a pacing indication referred for consideration of an ICD, the majority were eligible for S-ICD. The S-ICD is effective at recognizing and terminating VF at implant with a wide safety margin. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Uncommon combinations of ICD10-PCS or ICD-9-CM operative procedure codes account for most inpatient surgery at half of Texas hospitals.

PubMed

O'Neill, Liam; Dexter, Franklin; Park, Sae-Hwan; Epstein, Richard H

2017-09-01

Recently, there has been interest in activity-based cost accounting for inpatient surgical procedures to facilitate "value based" analyses. Research 10-20years ago, performed using data from 3 large teaching hospitals, found that activity-based cost accounting was practical and useful for modeling surgeons and subspecialties, but inaccurate for individual procedures. We hypothesized that these older results would apply to hundreds of hospitals, currently evaluable using administrative databases. Observational study. State of Texas hospital discharge abstract data for 1st quarter of 2016, 4th quarter of 2015, 1st quarter of 2015, and 4th quarter of 2014. Discharged from an acute care hospital in Texas with at least 1 major therapeutic ("operative") procedure. Counts of discharges for each procedure or combination of procedures, classified by ICD-10-PCS or ICD-9-CM. At the average hospital, most surgical discharges were for procedures performed at most once a month at the hospital (54%, 95% confidence interval [CI] 51% to 55%). At the average hospital, approximately 90% of procedures were performed at most once a month at the hospital (93%, CI 93% to 94%). The percentages were insensitive to the quarter of the year. The percentages were 3% to 6% greater with ICD-10-PCS than for the superseded ICD 9 CM. There are many different procedure codes, and many different combinations of codes, relative to the number of different hospital discharges. Since most procedures at most hospitals are performed no more than once a month, activity-based cost accounting with a sample size sufficient to be useful is impractical for the vast majority of procedures, in contrast to analysis by surgeon and/or subspecialty. Copyright © 2017 Elsevier Inc. All rights reserved.

Shock whilst gardening--implantable defibrillators & lawn mowers.

PubMed

Von Olshausen, G; Lennerz, C; Grebmer, C; Pavaci, H; Kolb, C

2014-02-01

Electromagnetic interference with implantable cardioverter defibrillators (ICDs) can cause inappropriate shock delivery or temporary inhibition of ICD functions. We present a case of electromagnetic interference between a lawn mower and an ICD resulting in an inappropriate discharge of the device due to erroneous detection of ventricular fibrillation.

Preparing your organization's training program for ICD-10.

PubMed

Carolan, Katie; Reitzel, David

2011-10-01

Training for ICD-10 is going to be expensive, though predictions of how expensive vary widely. Healthcare finance executives should create a flexible, multiyear capital and operating budget to prepare for ICD-10 conversion and the training and support that will be required. Healthcare organizations also should assess staff knowledge in the critical ICD-10 areas and begin training now to be ready for go-live by early 2013.

[Pre-operation evaluation and intra-operation management of cochlear implantation].

PubMed

Zhang, Dao-xing; Hu, Bao-hua; Xiao, Yu-li; Shi, Bo-ning

2004-10-01

To summarize pre-operation evaluation experiences in cochlear implantation. Performing auditory evaluation and image analysis seriously in 158 severe hearing loss or total deaf cases before cochlear implantation, comparing their performance with the findings during and post operation. Among the total 158 cases, 116 cases with normal structure, 42 cases with the abnormal findings of the inner or middle ear. Stapedial gusher happened in 6 cases, 1 case was not predicted before operation. Except 1 case with serious malformation, the findings of other 157 cases in operation were consistent with the pre-operation evaluation. We helped all patients reconstruct auditory conduction with cochlear implantation, and the average hearing level up to 37.6 dB SPL. Performing image analysis seriously before operation and planning for operation according to HRCT can do great help to cochlear implantation. The operation under the HRCT instruction has less complications.

Sudden cardiac death: a critical appraisal of the implantable cardioverter defibrillator.

PubMed

Rajabali, A; Heist, E K

2014-04-01

Approximately 350,000 Americans still die of sudden cardiac death each year. This exceeds the number of patients who die annually from stroke, lung cancer, breast cancer and AIDS combined. This review aims to trace the history of implantable cardioverter defibrillators (ICD) with reference to landmark trials and their influence on the formulation of Medicare guidelines for ICD implantation criteria. This paper will also discuss the cost-effectiveness of ICDs and the quality of life after implantation. The reasons for the disparity between guidelines for implantation and actual clinical practice will be elucidated, with suggestions for improving overall clinical performance. The ICD has been shown to be cost-effective in reducing sudden cardiac death and all-cause mortality. However, the existing recommendations for ICD implantation have yet to translate completely into clinical practice. Barriers to implementation of existing guidelines include knowledge gaps in the referring physician practices, lack of validated screening tools to assess patient candidacy for the device and patient understanding of the need for the device. Future strategies to increase compliance with the existing guidelines and improve clinical performance are areas of potential research focus. © 2013 John Wiley & Sons Ltd.

Subcutaneous ICD screening with the Boston Scientific ZOOM programmer versus a 12-lead ECG machine.

PubMed

Chang, Shu C; Patton, Kristen K; Robinson, Melissa R; Poole, Jeanne E; Prutkin, Jordan M

2018-02-24

The subcutaneous implantable cardioverter-defibrillator (S-ICD) requires preimplant screening to ensure appropriate sensing and reduce risk of inappropriate shocks. Screening can be performed using either an ICD programmer or a 12-lead electrocardiogram (ECG) machine. It is unclear whether differences in signal filtering and digital sampling change the screening success rate. Subjects were recruited if they had a transvenous single-lead ICD without pacing requirements or were candidates for a new ICD. Screening was performed using both a Boston Scientific ZOOM programmer (Marlborough, MA, USA) and General Electric MAC 5000 ECG machine (Fairfield, CT, USA). A pass was defined as having at least one lead that fit within the screening template in both supine and sitting positions. A total of 69 subjects were included and 27 sets of ECG leads had differing screening results between the two machines (7%). Of these sets, 22 (81%) passed using the ECG machine but failed using the programmer and five (19%) passed using the ECG machine but failed using the programmer (P < 0.001). Four subjects (6%) passed screening using the ECG machine but failed using the programmer. No subject passed screening with the programmer but failed with the ECG machine. There can be occasional disagreement in S-ICD patient screening between an ICD programmer and ECG machine, all of whom passed with the ECG machine but failed using the programmer. On a per lead basis, the ECG machine passes more subjects. It is unknown what the inappropriate shock rate would be if an S-ICD was implanted. Clinical judgment should be used in borderline cases. © 2018 Wiley Periodicals, Inc.

Safety of Electromagnetic Articulography in Patients with Pacemakers and Implantable Cardioverter-Defibrillators

ERIC Educational Resources Information Center

Joglar, Jose A.; Nguyen, Carol; Garst, Diane M.; Katz, William F.

2009-01-01

Purpose: "Electromagnetic articulography (EMA)" uses a helmet to create alternating magnetic fields for tracking speech articulator movement. An important safety consideration is whether EMA magnetic fields interfere with the operation of speakers' pacemakers or implantable cardioverter-defibrillators (ICDs). In this investigation,…

Determinants of geographic variations in implantation of cardiac defibrillators in the European Society of Cardiology member countries--data from the European Heart Rhythm Association White Book.

PubMed

Lubinski, Andrzej; Bissinger, Andrzej; Boersma, Lucas; Leenhardt, Antoine; Merkely, Bela; Oto, Ali; Proclemer, Alessandro; Brugada, Josep; Vardas, Panos E; Wolpert, Christian

2011-05-01

Sudden cardiac death (SCD) is a major health concern in developed countries. Many studies have demonstrated the efficacy of implantable cardioverter defibrillator (ICD) therapy in the prevention of SCD and total mortality reduction. However, the high individual costs and the reimbursement policy may limit widespread ICD utilization. This study analyzed the temporal and the geographical trends of the ICD implantation rate. Data were gathered from two editions of the European Heart Rhythm Association (EHRA) White Books published in 2008 and 2009. The analysis revealed significant differences in the rates of ICD implantation per million capita between the countries, but the median implantations was constantly increasing. The number of ICD implantations correlated with gross domestic product (GDP), GDP per capita, expenditure on health, life expectancy, and the number of implanting centres. There are great number of differences in the ICD-implanting rates between EHRA member countries, consequent to the increase in the number of ICD implantations. The ICD implantation rates are related to national economic status and healthcare expenses.

Impact of the introduction of a standardised ICD programming protocol: real-world data from a single centre.

PubMed

Sunderland, Nicholas; Kaura, Amit; Li, Anthony; Kamdar, Ravi; Petzer, Ed; Dhillon, Para; Murgatroyd, Francis; Scott, Paul A

2016-09-01

Randomised trials have shown that empiric ICD programming, using long detection times and high detection zones, reduces device therapy in ICD recipients. However, there is less data on its effectiveness in a "real-world" setting, especially secondary prevention patients. Our aim was to evaluate the introduction of a standardised programming protocol in a real-world setting of unselected ICD recipients. We analysed 270 consecutive ICD recipients implanted in a single centre-135 implanted prior to protocol implementation (physician-led group) and 135 after (standardised group). The protocol included long arrhythmia detection times (30/40 or equivalent) and high rate detection zones (primary prevention lower treatment zone 200 bpm). Programming in the physician-led group was at the discretion of the implanter. The primary endpoint was time-to-any therapy (ATP or shocks). Secondary endpoints were time-to-inappropriate therapy and time-to-appropriate therapy. The safety endpoints were syncopal episodes, hospital admissions and death. At 12 months follow-up, 47 patients had received any ICD therapy (physician-led group, n = 31 vs. standardised group, n = 16). There was a 47 % risk reduction in any device therapy (p = 0.04) and an 86 % risk reduction in inappropriate therapy (p = 0.009) in the standardised compared to the physician-led group. There was a non-significant 30 % risk reduction in appropriate therapy (p = 0.32). Results were consistent across primary and secondary prevention patients. There were no significant differences in the rates of syncope, hospitalisation, and death. In unselected patients in a real-world setting, introduction of a standardised programming protocol, using long detection times and high detection zones, significantly reduces the burden of ICD therapy without an increase in adverse outcomes.

Clinical Experience With the Subcutaneous Implantable Cardioverter-Defibrillator in Adults With Congenital Heart Disease.

PubMed

Moore, Jeremy P; Mondésert, Blandine; Lloyd, Michael S; Cook, Stephen C; Zaidi, Ali N; Pass, Robert H; John, Anitha S; Fish, Frank A; Shannon, Kevin M; Aboulhosn, Jamil A; Khairy, Paul

2016-09-01

Sudden cardiac death is a major contributor to mortality for adults with congenital heart disease. The subcutaneous implantable cardioverter-defibrillator (ICD) has emerged as a novel tool for prevention of sudden cardiac death, but clinical performance data for adults with congenital heart disease are limited. A retrospective study involving 7 centers over a 5-year period beginning in 2011 was performed. Twenty-one patients (median 33.9 years) were identified. The most common diagnosis was single ventricle physiology (52%), 9 palliated by Fontan operation and 2 by aortopulmonary shunts: d-transposition of the great arteries after Mustard/Senning (n=2), tetralogy of Fallot (n=2), aortic valve disease (n=2), and other biventricular surgery (n=4). A prior cardiac device had been implanted in 7 (33%). The ICD indication was primary prevention in 67% and secondary in 33% patients. The most common reason for subcutaneous ICD placement was limited transvenous access for ventricular lead placement (n=10) followed by intracardiac right-to-left shunt (n=5). Ventricular arrhythmia was induced in 17 (81%) and was converted with ≤80 Joules in all. There was one implant complication related to infection, not requiring device removal. Over a median follow-up of 14 months, 4 patients (21%) received inappropriate and 1 (5%) patient received appropriate shocks. There was one arrhythmic death related to asystole in a single ventricle patient. Subcutaneous ICD implantation is feasible for adults with congenital heart disease patients. Most candidates have single ventricle heart disease and limited transvenous options for ICD placement. Despite variable anatomy, this study demonstrates successful conversion of induced ventricular arrhythmia and reasonable rhythm discrimination during follow-up. © 2016 American Heart Association, Inc.

Pulse Generator Exchange Does Not Accelerate the Rate of Electrical Failure in a Recalled Small Caliber ICD Lead.

PubMed

Lovelock, Joshua D; Premkumar, Ajay; Levy, Mathew R; Mengistu, Andenet; Hoskins, Michael H; El-Chami, Mikhael F; Lloyd, Michael S; Leon, Angel R; Langberg, Jonathan J; Delurgio, David B

2015-12-01

St. Jude Riata/Riata ST defibrillator leads (St. Jude Medical, Sylmar, CA, USA) were recalled by the Food and Drug Administration in 2011 for an increased rate of failure. More than 227,000 leads were implanted and at least 79,000 patients still have active Riata leads. Studies have examined clinical predictors of lead failure in Riata leads, but none have addressed the effect of implantable cardioverter defibrillator (ICD) generator exchange on lead failure. The purpose of this study is to assess the effect of ICD generator exchange on the rate of electrical failure in the Riata lead at 1 year. A retrospective chart review was conducted in patients who underwent implantation of a Riata/Riata ST lead at one center. Patients with a functioning Riata lead (with/without externalized conductor) at the time of ICD exchange were compared to controls with Riata leads implanted for a comparable amount of time who did not undergo generator replacement. Riata leads were implanted in 1,042 patients prior to the recall and 153 of these patients underwent generator exchange without lead replacement. Conductor externalization was noted in 21.5% of Riata leads in the ICD exchange cohort, which was not different from the control group (19.2%; P = 0.32). Two leads failed in the first year after generator replacement (1.5%) which did not significantly differ from the control group (2.0%; P = 0.57). At change-out, 54% received a commanded shock (18.6 ± 0.9 J) that did not result in any change in the high-voltage lead impedance (46.1 ± 1.1 ohms). Conductor externalization was seen frequently in our cohort of patients. ICD generator exchange did not accelerate the rate of Riata lead failure at 1 year. Although both the control and the change-out cohorts failed at a rate much greater than nonrecalled leads, generator exchange did not appear to add to the problem. ©2015 Wiley Periodicals, Inc.

Acute and Long-term Results After Contemporary Subcutaneous Implantable Cardioverter-defibrillator Implantation: A Single-center Experience.

PubMed

Arias, Miguel A; Pachón, Marta; Akerström, Finn; Puchol, Alberto; Martín-Sierra, Cristina; Rodríguez-Padial, Luis

2017-12-05

The subcutaneous implantable cardioverter-defibrillator (S-ICD) has emerged as an alternative to the transvenous defibrillator. The incidence of complications is similar, with inappropriate shocks (IS) being more frequent than those occurring with contemporary programming of transvenous defibrillators. Several improvements have been implemented after the S-ICD was approved for use in Europe in 2009. This study reports the results of S-ICD use in a single center, whose experience began late, at the end of 2013. Prospective observational study including consecutive patients with defibrillator indication and no indication for either permanent pacing or cardiac resynchronization who underwent S-ICD implantation. Implant data and long-term follow-up were analyzed. An S-ICD was implanted in 50 patients who were deemed suitable after electrocardiographic screening. The mean age was 46.9±15 (range, 15-78) years and 72% were male. Thirty eight percent had left ventricular ejection fraction ≤ 35%. The most frequent heart disease was ischemic heart disease (34%), followed by hypertrophic cardiomyopathy (18%). The intermuscular technique was used, with 3 incisions in 10% and 2 incisions in the remaining 90%. Ventricular fibrillation was induced in 49 patients, with 100% effectiveness in their conversion. After a mean follow-up of 18.1 (range, 2.3-44.8) months, there were no late complications requiring surgical revision, the rate of IS was 0%, and 1 patient (2%) experienced appropriate shocks. Improvements in technology, implant technique and device programming, along with appropriate patient selection, have led to outstanding acute and long-term results, especially regarding the absence of both IS and complications requiring surgical revision. Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

Impaired left atrial function predicts inappropriate shocks in primary prevention implantable cardioverter-defibrillator candidates.

PubMed

Tao, Susumu; Ashikaga, Hiroshi; Ciuffo, Luisa A; Yoneyama, Kihei; Lima, Joao A C; Frank, Terry F; Weiss, Robert G; Tomaselli, Gordon F; Wu, Katherine C

2017-07-01

Inappropriate implantable cardioverter-defibrillator (ICD) shocks, commonly caused by atrial fibrillation (AF), are associated with an increased mortality. Because impaired left atrial (LA) function predicts development of AF, we hypothesized that impaired LA function predicts inappropriate shocks beyond a history of AF. We prospectively analyzed the association between LA function and incident inappropriate shocks in primary prevention ICD candidates. In the Prospective Observational Study of ICD (PROSE-ICD), we assessed LA function using tissue-tracking cardiac magnetic resonance (CMR) prior to ICD implantation. A total of 162 patients (113 males, age 56 ± 15 years) were included. During the mean follow-up of 4.0 ± 2.9 years, 26 patients (16%) experienced inappropriate shocks due to AF (n = 19; 73%), supraventricular tachycardia (n = 5; 19%), and abnormal sensing (n = 2; 8%). In univariable analyses, inappropriate shocks were associated with AF history prior to ICD implantation, age below 70 years, QRS duration less than 120 milliseconds, larger LA minimum volume, lower LA stroke volume, lower LA emptying fraction, impaired LA maximum and preatrial contraction strains (S max and S preA ), and impaired LA strain rate during left ventricular systole and atrial contraction (SR s and SR a ). In multivariable analysis, impaired S max (hazard ratio [HR]: 0.96, P = 0.044), S preA (HR: 0.94, P = 0.030), and SR a (HR: 0.25, P < 0.001) were independently associated with inappropriate shocks. The receiver-operating characteristics curve showed that SR a improved the predictive value beyond the patient demographics including AF history (P = 0.033). Impaired LA function assessed by tissue-tracking CMR is an independent predictor of inappropriate shocks in primary prevention ICD candidates beyond AF history. © 2017 Wiley Periodicals, Inc.

Living with hypertrophic cardiomyopathy and an implantable defibrillator.

PubMed

Magnusson, Peter; Jonsson, Jessica; Mörner, Stellan; Fredriksson, Lennart

2017-05-10

ICDs efficiently terminate life-threatening arrhythmias, but complications occur during long-term follow-up. Patients' own perspective is largely unknown. The aim of the study was to describe experiences of hypertrophic cardiomyopathy (HCM) patients with implantable defibrillators (ICDs). We analyzed 26 Swedish patient interviews using hermeneutics and latent content analysis. Patients (aged 27-76 years) were limited by HCM especially if it deteriorates into heart failure. The ICD implies safety, gratitude, and is accepted as a part of the body even when inappropriate ICD shocks are encountered. Nobody regretted the implant. Both the disease and the ICD affected professional life and leisure time activities, especially at younger ages. Family support was usually strong, but sometimes resulted in overprotection, whereas health care focused on medical issues. Despite limitations, patients adapted, accepted, and managed challenges. HCM patients with ICDs reported good spirit and hope even though they had to adapt and accept limitations over time.

The learning curve associated with the introduction of the subcutaneous implantable defibrillator.

PubMed

Knops, Reinoud E; Brouwer, Tom F; Barr, Craig S; Theuns, Dominic A; Boersma, Lucas; Weiss, Raul; Neuzil, Petr; Scholten, Marcoen; Lambiase, Pier D; Leon, Angel R; Hood, Margaret; Jones, Paul W; Wold, Nicholas; Grace, Andrew A; Olde Nordkamp, Louise R A; Burke, Martin C

2016-07-01

The subcutaneous implantable cardioverter defibrillator (S-ICD) was introduced to overcome complications related to transvenous leads. Adoption of the S-ICD requires implanters to learn a new implantation technique. The aim of this study was to assess the learning curve for S-ICD implanters with respect to implant-related complications, procedure time, and inappropriate shocks (IASs). In a pooled cohort from two clinical S-ICD databases, the IDE Trial and the EFFORTLESS Registry, complications, IASs at 180 days follow-up and implant procedure duration were assessed. Patients were grouped in quartiles based on experience of the implanter and Kaplan-Meier estimates of complication and IAS rates were calculated. A total of 882 patients implanted in 61 centres by 107 implanters with a median of 4 implants (IQR 1,8) were analysed. There were a total of 59 patients with complications and 48 patients with IAS. The complication rate decreased significantly from 9.8% in Quartile 1 (least experience) to 5.4% in Quartile 4 (most experience) (P = 0.02) and non-significantly for IAS from 7.9 to 4.8% (P = 0.10). Multivariable analysis demonstrated a hazard ratio of 0.78 (P = 0.045) for complications and 1.01 (P = 0.958) for IAS. Dual-zone programming increased with experience of the individual implanter (P < 0.001), which reduced IAS significantly in the multivariable model (HR 0.44, P = 0.01). Procedure time decreased from 75 to 65 min (P < 0.001). The complication rate and procedure time stabilized after Quartile 2 (>13 implants). There is a short and significant learning curve associated with physicians adopting the S-ICD. Performance stabilizes after 13 implants. © The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.

[Full dental rehabilitation of a patient with implantable cardioverter defibrillator].

PubMed

Imre, Ildikó; Tóth, Zsuzsanna

2012-06-01

During dental rehabilitation of a patient with ICD, an upper telescope retained overdenture with acrylic baseplate and lower cantilever bridges were constructed. In the consultation following the anamnesis and the clinical examination, the cardiologist did not believe antibiotic profilaxis to be necessary, adding that it is advisable to avoid the use of ultrasonic depurator and electrocauter. Nowadays after saving the life the improving of patient's better quality of life is an important aspect. The risk of ICD-implantation is minimal however, not negligible, the patient can pursue a way of life free of limitation. According to the latest trends, the number of ICD-implantations will increase exponentially in the near future, due to the aging of the population, the simplification and safeness of implantation and the increase of patients who can be treated with the device. In case of arritmia or putative dysfunction, the latest ICD-s are able to send emergency alert to the arritmia centre with the help of an outer transmitter. Probably the system will completely change the follow-up of patients with ICD within the next few years, clinical researches of its efficiency are going on at present.

Single-coil and dual-coil defibrillator leads and association with clinical outcomes in a complete Danish nationwide ICD cohort.

PubMed

Larsen, Jacob M; Hjortshøj, Søren P; Nielsen, Jens C; Johansen, Jens B; Petersen, Helen H; Haarbo, Jens; Johansen, Martin B; Thøgersen, Anna Margrethe

2016-03-01

The best choice of defibrillator lead in patients with routine implantable cardioverter-defibrillator (ICD) is not settled. Traditionally, most physicians prefer dual-coil leads but the use of single-coil leads is increasing. The purpose of this study was to compare clinical outcomes in patients with single- and dual-coil leads. All 4769 Danish patients 18 years or older with first-time ICD implants from 2007 to 2011 were included from the Danish Pacemaker and ICD Register. Defibrillator leads were 38.9% single-coil leads and 61.1% dual-coil leads. The primary end point was all-cause mortality. Secondary end points were lowest successful energy at implant defibrillation testing, first shock failure in spontaneous arrhythmias, structural lead failure, and lead extraction outcomes. Single-coil leads were associated with lower all-cause mortality with an adjusted hazard ratio of 0.85 (95% confidence interval 0.73-0.99; P = .04). This finding was robust in a supplementary propensity score-matched analysis. However, dual-coil leads were used in patients with slightly higher preimplant morbidity, making residual confounding by indication the most likely explanation for the observed association between lead type and mortality. The lowest successful defibrillation energy was higher using single-coil leads (23.2 ± 4.3 J vs 22.1 ± 3.9 J; P < .001). No significant differences were observed for other secondary end points showing high shock efficacies and low rates of lead failures and extraction complications. Shock efficacy is high for modern ICD systems. The choice between single-coil and dual-coil defibrillator leads is unlikely to have a clinically significant impact on patient outcomes in routine ICD implants. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Gender disparities in quality of life and psychological disturbance in patients with implantable cardioverter-defibrillators.

PubMed

Rahmawati, Anita; Chishaki, Akiko; Sawatari, Hiroyuki; Tsuchihashi-Makaya, Miyuki; Ohtsuka, Yuko; Nakai, Mori; Miyazono, Mami; Hashiguchi, Nobuko; Sakurada, Harumizu; Takemoto, Masao; Mukai, Yasushi; Inoue, Shujiro; Sunagawa, Kenji; Chishaki, Hiroaki

2013-01-01

Implantable cardioverter-defibrillator (ICD) has improved prognosis in fatal arrhythmia and the number of ICD implantations has increased. ICD-related psychological problems and impaired quality of life (QOL), however, have been observed. This study examined whether gender differences exist in QOL and psychological disturbances in ICD patients. Consecutive outpatients (n=179; mean age, 60.5±15.9 years; 81% male) with ICD implantations completed questionnaires consisting of the Short Form-8 (SF-8), Beck Depression Inventory, Impact of Event Scale-Revised (IES-R), State-Trait Anxiety Inventory, and Worries about ICD. One-way multivariate analysis of variance (MANOVA) showed women to have impaired QOL on the role physical functioning (F15,157=4.57, P<0.05) and bodily pain (F15,157=5.26, P<0.05) subscales of the SF-8. More women reported depression (F15,157=5.37, P<0.05) and worry about ICD than men (F15,157=6.62, P<0.05). Moreover, women also had higher IES-R scores indicating post-traumatic stress disorder (PTSD) than men (F15,157=5.87, P<0.05). Women reported poorer QOL on 2 subscales: role physical functioning and bodily pain. There was a significant relationship between gender and depression, worry about ICD, and PTSD, but not for anxiety. Female patients need more psychological interventions following ICD implantation.  

[Tachycardia detection in implantable cardioverter-defibrillators by Sorin/LivaNova : Algorithms, pearls and pitfalls].

PubMed

Kolb, Christof; Ocklenburg, Rolf

2016-09-01

For physicians involved in the treatment of patients with implantable cardioverter-defibrillators (ICDs) the knowledge of tachycardia detection algorithms is of paramount importance. This knowledge is essential for adequate device selection during de-novo implantation, ICD replacement, and for troubleshooting during follow-up. This review describes tachycardia detection algorithms incorporated in ICDs by Sorin/LivaNova and analyses their strengths and weaknesses.

The Design of the Understanding Outcomes with the S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED).

PubMed

Gold, Michael R; Knops, Reinoud; Burke, Martin C; Lambiase, Pier D; Russo, Andrea M; Bongiorni, Maria Grazia; Deharo, Jean-Claude; Aasbo, Johan; El Chami, Mikhael F; Husby, Michael; Carter, Nathan; Boersma, Lucas

2017-01-01

The UNTOUCHED study will assess the safety and efficacy of the subcutaneous implantable cardioverter defibrillator (S-ICD) in the most common cohort of patients receiving ICDs. The primary goal is to evaluate the inappropriate shock (IAS)-free rate in primary prevention patients with a reduced ejection fraction (EF) and compare with a historical control of transvenous ICD patients with similar programming. The UNTOUCHED study is a global, multicenter, prospective, nonrandomized study of patients undergoing de novo S-ICD implantation for primary prevention of sudden cardiac death with a left ventricular EF ≤35%. The primary end point of this trial is freedom from IAS at 18 months. The lower 95% confidence bound of the observed incidence will be compared to a performance goal of 91.6%, which was derived from the IAS rate in MADIT-RIT. The secondary end points are all-cause shock-free rate at 18 months, and system- and procedure-related complication-free rate at 1 month and 6 months. Enrollment of a minimum of 1,100 subjects from up to 200 centers worldwide is planned based on power calculations of the primary and principal secondary end points. This trial will provide important data regarding the rates of inappropriate and appropriate shock therapy in real-world use of the S-ICD in the most common group of patients receiving ICDs. © 2016 Wiley Periodicals, Inc.

"Pseudo" Faraday cage: a solution for telemetry link interaction between a left ventricular assist device and an implantable cardioverter defibrillator.

PubMed

Jacob, Sony; Cherian, Prasad K; Ghumman, Waqas S; Das, Mithilesh K

2010-09-01

Patients implanted with left ventricular assist devices (LVAD) may have implantable cardioverter defibrillators (ICD) implanted for sudden cardiac death prevention. This opens the possibility of device-device communication interactions and thus interferences. We present a case of such interaction that led to ICD communication failure following the activation of an LVAD. In this paper, we describe a practical solution to circumvent the communication interference and review the communication links of ICDs and possible mechanisms of ICD-LVAD interactions.

Development of structured ICD-10 and its application to computer-assisted ICD coding.

PubMed

Imai, Takeshi; Kajino, Masayuki; Sato, Megumi; Ohe, Kazuhiko

2010-01-01

This paper presents: (1) a framework of formal representation of ICD10, which functions as a bridge between ontological information and natural language expressions; and (2) a methodology to use formally described ICD10 for computer-assisted ICD coding. First, we analyzed and structurized the meanings of categories in 15 chapters of ICD10. Then we expanded the structured ICD10 (S-ICD10) by adding subordinate concepts and labels derived from Japanese Standard Disease Names. The information model to describe formal representation was refined repeatedly. The resultant model includes 74 types of semantic links. We also developed an ICD coding module based on S-ICD10 and a 'Coding Principle,' which achieved high accuracy (>70%) for four chapters. These results not only demonstrate the basic feasibility of our coding framework but might also inform the development of the information model for formal description framework in the ICD11 revision.

Psychological and clinical problems in young adults with implantable cardioverter-defibrillators.

PubMed

Wójcicka, Mariola; Lewandowski, Michał; Smolis-Bak, Edyta; Szwed, Hanna

2008-10-01

Implantable cardioverter-defibrillators (ICD) are the most effective treatment in patients with the risk of sudden cardiac death. ICD improves patients' safety but is also the source of numerous inconveniences. Especially young people consider such ICD-related inconveniences as most unwelcome. To assess the quality of life and main psychological problems encountered in young adults with an ICD. We studied 45 subjects aged 14-29 years (mean 21.2+/-4.3). ICDs were used in primary prevention in 22 patients, and in secondary prevention in 23 patients. Time elapsed from implantation ranged from 5 months to 11 years (4.3+/-2.7 years). Since the problems affecting this group were rather specific, the patients' quality of life was assessed with a special questionnaire addressing important issues and problems associated with living with an ICD. ICD discharges were observed in 67.4% of patients (primary prevention - 45.5%, secondary prevention - 82.6%), multiple shocks in 47.2%, and phantom shocks in 21.4%. Anxiety associated with an ICD discharge was reported by 84.4% of patients. In order to prevent ICD discharges, 53.3% of patients decreased their activity. Problems with memory were observed in 42.2% of patients, with concentration in 47.6%, and with sleep in 42.2%. Almost half of those over 18 years of age were active drivers. None of the subjects experienced an ICD discharge during sexual intercourse. None of the men reported any sexual problems, while seven (41.2%) women did. Almost a quarter of the patients claimed to have had complications after the implantation. Young adult patients generally were compliant to have their ICD checked and accepted their limitations and disease. Fewer people assessed their health status as bad. Some patients in the group studied found it extremely difficult to accept their disease and/or ICD and to adapt to the situation. As many as nine patients believed the ICD implantation had been unnecessary, seven did not accept the ICD, three

Wearable cardioverter defibrillator: Bridge or alternative to implantation?

PubMed Central

Barraud, Jeremie; Cautela, Jennifer; Orabona, Morgane; Pinto, Johan; Missenard, Olivier; Laine, Marc; Thuny, Franck; Paganelli, Franck; Bonello, Laurent; Peyrol, Michael

2017-01-01

The implantable cardioverter-defibrillator (ICD) is effective to prevent sudden cardiac death (SCD) in selected patients with heart disease known to be at high risk for ventricular arrhythmia. Nevertheless, this invasive and definitive therapy is not indicated in patients with potentially transient or reversible causes of sudden death, or in patients with temporary contra-indication for ICD placement. The wearable cardioverter defibrillator (WCD) is increasingly used for SCD prevention both in patients awaiting ICD implantation or with an estimated high risk of ventricular arrhythmia though to be transient. We conducted a review of current clinical uses and benefits of the WCD, and described its technical aspects, limitations and perspectives. PMID:28706588

Inappropriate Implantable Cardioverter-Defibrillator Shocks Attributed to Alternating-Current Leak in a Swimming Pool

PubMed Central

Makaryus, John N.; Angert-Gilman, Julia; Yacoub, Mena; Patel, Apoor

2014-01-01

Implantable cardioverter-defibrillators (ICDs) are the standard of care for preventing sudden cardiac death in patients who are predisposed to malignant ventricular arrhythmias. Causes of inappropriate ICD shock include equipment malfunction, improper arrhythmia evaluation, misinterpretation of myopotentials, and electromagnetic interference. As the number of implanted ICDs has increased, other contributors to inappropriate therapy have become known, such as minimal electrical current leaks that mimic ventricular fibrillation. We present the case of a 63-year-old man with a biventricular ICD who received 2 inappropriate shocks, probably attributable to alternating-current leaks in a swimming pool. In addition, we discuss ICD sensitivity and offer recommendations to avoid similar occurrences. PMID:24512403

Chronic lymphocytic leukemia skin infiltration mimicking an ICD pocket infection: a case report.

PubMed

Snorek, M; Bulava, A; Vonke, I

2017-03-24

We are presenting a case report on an unreported and unusual cutaneous manifestation of chronic lymphocytic leukemia in a patient with an implantable cardioverter-defibrillator (ICD). A 65-year-old man with a history of chronic lymphocytic leukemia (CLL), previously treated with chlorambucil, was referred in October 2013 for extraction of a single chamber ICD due to a suspected device-related infection in the pulse generator area (left-hand side of Fig. 1). The ICD system (Current VR, St. Jude Medical, USA) had been implanted in November 2009. The patient complained of painless erythema with pruritus in the pocket area. Inflammatory blood parameters were C-reactive protein 17.3 mg/L and leucocytes 29.0 × 10 9 /L. Due to the atypical appearance of the pocket area we did not extract the device. Instead, we created an exploratory excision in the skin induration, which had been present for approximately 6 weeks, and conducted a microbiological and histological examination. All cultivation examinations were negative. However, we did histologically show skin infiltration by CD-5 positive low-grade B-cell chronic lymphocytic leukemia/small lymphocytic lymphoma (B-CLL/SLL). Re-initiation of chemotherapy was not necessary and the skin induration completely disappeared within 2 months (right-hand side of Fig. 1). Complete removal of an ICD system carries considerable risk. In patients with a history of hematological disease, it is crucial to exclude cutaneous manifestations of the disease prior to device removal.

Epicardial cardioverter-defibrillator implantation in a 4-month-old infant bridged to heart transplantation.

PubMed

Carro, Cristina; Cereda, Alberto Francesco; Annoni, Giuseppe; Marianeschi, Stefano Maria

2017-11-01

Implantable cardioverter-defibrillator (ICD) is the gold standard therapy for the prevention of sudden cardiac death. Nevertheless, ICD placement in the paediatric population is still limited because of several technical difficulties. Several implantation techniques have been proposed but experience in infants with very low weight and less than 6 months is very limited. We herein describe a case of a minimally invasive ICD epicardial implantation in a 4-month-old infant weighing 5 kg. A diagnosis of arrhythmic cardiomyopathy with left ventricular non-compaction disease with ventricular tachycardia storms, QT prolongation and Wolff-Parkinson-White pattern was made. Antiarrhythmic drugs, radiofrequency ablation and sympathetic denervation were not effective. ICD implantation was successful allowing the infant to survive and bridging to heart transplantation. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Open-access programs for injury categorization using ICD-9 or ICD-10.

PubMed

Clark, David E; Black, Adam W; Skavdahl, David H; Hallagan, Lee D

2018-04-09

The article introduces Programs for Injury Categorization, using the International Classification of Diseases (ICD) and R statistical software (ICDPIC-R). Starting with ICD-8, methods have been described to map injury diagnosis codes to severity scores, especially the Abbreviated Injury Scale (AIS) and Injury Severity Score (ISS). ICDPIC was originally developed for this purpose using Stata, and ICDPIC-R is an open-access update that accepts both ICD-9 and ICD-10 codes. Data were obtained from the National Trauma Data Bank (NTDB), Admission Year 2015. ICDPIC-R derives CDC injury mechanism categories and an approximate ISS ("RISS") from either ICD-9 or ICD-10 codes. For ICD-9-coded cases, RISS is derived similar to the Stata package (with some improvements reflecting user feedback). For ICD-10-coded cases, RISS may be calculated in several ways: The "GEM" methods convert ICD-10 to ICD-9 (using General Equivalence Mapping tables from CMS) and then calculate ISS with options similar to the Stata package; a "ROCmax" method calculates RISS directly from ICD-10 codes, based on diagnosis-specific mortality in the NTDB, maximizing the C-statistic for predicting NTDB mortality while attempting to minimize the difference between RISS and ISS submitted by NTDB registrars (ISSAIS). Findings were validated using data from the National Inpatient Survey (NIS, 2015). NTDB contained 917,865 cases, of which 86,878 had valid ICD-10 injury codes. For a random 100,000 ICD-9-coded cases in NTDB, RISS using the GEM methods was nearly identical to ISS calculated by the Stata version, which has been previously validated. For ICD-10-coded cases in NTDB, categorized ISS using any version of RISS was similar to ISSAIS; for both NTDB and NIS cases, increasing ISS was associated with increasing mortality. Prediction of NTDB mortality was associated with C-statistics of 0.81 for ISSAIS, 0.75 for RISS using the GEM methods, and 0.85 for RISS using the ROCmax method; prediction of NIS mortality

Clinical performance of different DF-4 implantable cardioverter defibrillator leads.

PubMed

Sarrazin, Jean-François; Philippon, François; Sellier, Romain; André, Philippe; O'Hara, Gilles; Molin, Franck; Nault, Isabelle; Blier, Louis; Champagne, Jean

2018-06-01

Implantable cardioverter-defibrillator (ICD) DF-4 connectors have been introduced to facilitate defibrillator lead connection and to reduce the size of device header. There are limited data regarding the overall performance of those leads and no comparison between different ICD DF-4 leads. This is a cohort study of consecutive patients implanted with ICD DF-4 lead system at one University Centre between October 2010 and February 2015. A historical control group of patients with ICD DF-1 lead implantation was used for comparison. The following ICD DF-4 leads were evaluated: St. Jude Medical Durata 7122Q (St. Jude Medical, St. Paul, MN, USA), Medtronic Sprint Quattro Secure 6935 M (Medtronic Inc., Minneapolis, MN, USA), Boston Scientific Endotak Reliance 4-Site 0293 (Boston Scientific, Marlborough, MA, USA), and Boston Scientific Reliance 4-Front 0693. This study evaluated the acute and mid-term performances of those leads as well as complications. A total of 812 patients (age 63 ± 12 years, 80% male, left ventricular ejection fraction 31 ± 12%) underwent implantation of an ICD DF-4 lead. Acute and follow-up R-wave sensing and threshold were excellent. Compared to implantation, intrinsic R waves were higher at follow-up for Boston Scientific and Medtronic leads, and pacing lead impedances were lower for all leads at first follow-up (P < 0.001). The number of lead dislodgement or failure was similar between all leads. The estimated lead survival rates at 3 years were 95.6% for Boston Scientific Endotak 4-Site, 97.1% for Boston Scientific 4-Front, 97.7% for Medtronic Sprint Quattro, and 97.5% for St. Jude Durata (P  =  0.553). All ICD DF-4 leads had excellent acute and mid-term electrical performances. Longer follow-up will be necessary to confirm their sustained performance. © 2018 Wiley Periodicals, Inc.

Utilization of implantable defibrillators in Africa.

PubMed

Millar, R N Scott; Mayosi, B M

2003-01-01

Sub-Saharan Africa is dominated by diseases of poverty. HIV/AIDS affects 28.5 out of a total of 600 million in the region. South Africa is the only country in sub-Saharan Africa in which implantable cardiovertor defibrillators (ICDs) are implanted (0.8/million in 2001). Only 3 of the 35 new ICDs were implanted in state-funded public hospitals. The pacemaker implantation rate for South Africa was 41/million in 2001. Approximately 20% of the population consume 56% of the health care expenditure, mainly funded by Medical Insurance. A tax-funded state health care system serves the rest of the population, but is concentrated on improving sanitation and primary health care. Diversion of funds from academic tertiary hospitals has reduced specialised services, particularly cardiology and cardiac surgery, and has resulted in an exodus of skilled personnel to the private sector. In the rest of sub-Saharan Africa, tertiary health care is mainly privately funded. Cardiology and cardiac surgery is not widely available. Many countries are crippled by debt and chronic local conflicts. Only one state hospital (Groote Schuur, Cape Town) provides an electrophysiology (EP) service including catheter ablation and ICD implantation, and training in EP, by two electrophysiologists. EP services are available privately in 3 centres. No EP service exists in the rest of sub-Saharan Africa.

[Fitness to drive in patients with implanted cardioverter-defibrillator].

PubMed

Klein, H H

2012-09-01

A physician who takes care for patients with implanted cardioverter-defibrillator (ICD) must inform them about their fitness to drive since these patients carry a higher risk for the occurrence of syncope or sudden cardiac death at the wheel. The driver's license law in Germany does not mention patients with ICD. The fitness to drive of patients with ICD is covered by the Advisory Board for Traffic Medicine in Germany (Bundesanstalt für Straßenwesen). These guidelines, however, are outdated and cannot be used to inform patients. Actually, these guidelines are under revision. Currently, the position paper of the German Society of Cardiology on "Fitness to drive and cardiovascular diseases" together with a recently published Dutch paper on this topic forms the basis of these recommendations. One week after ICD implantation for primary or one month after implantation for secondary prevention the patient may resume to drive. After adequate shocks the fitness to drive can be expected 2-4 months (3 months) later. The assessment of the fitness to drive has to be performed individually, taking into account also possible other influencing factors. In individual cases it appears to be justified that patients with ICD work as professional drivers. © Georg Thieme Verlag KG Stuttgart · New York.

A touch probe method of operating an implantable RFID tag for orthopedic implant identification.

PubMed

Liu, Xiaoyu; Berger, J Lee; Ogirala, Ajay; Mickle, Marlin H

2013-06-01

The major problem in operating an implantable radio-frequency identification (RFID) tag embedded on an orthopedic implant is low efficiency because of metallic interference. To improve the efficiency, this paper proposes a method of operating an implantable passive RFID tag using a touch probe at 13.56 MHz. This technology relies on the electric field interaction between two pairs of electrodes, one being a part of the touch probe placed on the surface of tissue and the other being a part of the tag installed under the tissue. Compared with using a conventional RFID antenna such as a loop antenna, this method has a better performance in the near field operation range to reduce interference with the orthopedic implant. Properly matching the touch probe and the tag to the tissue and the implant reduces signal attenuation and increases the overall system efficiency. The experiments have shown that this method has a great performance in the near field transcutaneous operation and can be used for orthopedic implant identification.

Nursing Home Use After Implantable Cardioverter-Defibrillator Implantation in Older Adults: Results from the National Cardiovascular Data Registry.

PubMed

Kramer, Daniel B; Reynolds, Matthew R; Normand, Sharon-Lise; Parzynski, Craig S; Spertus, John A; Mor, Vincent; Mitchell, Susan L

2017-02-01

To evaluate the incidence and characteristics of nursing home (NH) use after implantable cardioverter-defibrillator (ICD) implantation. Cohort study. Medicare beneficiaries in the National Cardiovascular Data Registry-ICD Registry. Individuals aged 65 and older receiving ICDs between January 1, 2006, and March 31, 2010 (N = 192,483). Proportion of ICD recipients discharged to NHs directly after device placement, cumulative incidence of long-term NH admission, and factors associated with immediate discharge to a NH and time to long-term NH admission. Over 4 years, 40.6% of the cohort died, and 35,939 (18.7%) experienced at least one NH admission, including 4.0% directly discharged to a NH after ICD implantation and 2.8% admitted to long-term NH care during follow-up. The cumulative incidence of long-term NH admission, accounting for the competing risk of death, was 1.7% at 1 year, 3.8% at 3 years, and 4.6% at 4 years; 20.1% of individuals admitted to a NH died there. Factors most strongly associated with direct NH discharge and time to long-term NH care were older age (adjusted odds ratio (AOR) = 2.09, 95% confidence interval (CI) = 2.01-2.17 per 10-year increment; adjusted hazard ratio (AHR) = 1.88, 95% CI = 1.80-1.97, respectively), dementia (AOR = 2.60, 95% CI = 2.25-3.01; AHR = 2.50, 95% CI = 2.14-2.93, respectively), and Medicare Part A claim for NH stay in prior 6 months (AOR = 3.96, 95% CI = 3.70-4.25; AHR = 2.88, 95% CI = 2.65-3.14, respectively). Nearly one in five individuals are admitted to NHs over a median of 1.6 years of follow-up after ICD implantation. Understanding these outcomes may help inform the clinical care of these individuals. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

Influence of time between last myocardial infarction and prophylactic implantable defibrillator implant on device detections and therapies. “Routine Practice” data from the SEARCH MI registry

PubMed Central

2012-01-01

Background A multicenter European Registry, SEARCH-MI, was instituted in the year 2002 in order to assess patients’ outcomes and ICD interventions in patients with a previous MI and depressed LV function, treated with an ICD according to MADIT II results. In this analysis, we evaluate the influence of the time elapsed between last myocardial infarction (MI) and prophylactic cardioverter defibrillator (ICD) implant on device activations. Methods 643 patients with left ventricular dysfunction (mean LVEF 26 ± 5%) and NYHA class I-III were prospectively followed for 1.8 ± 1.2 years in a multicenter registry. The population was divided into 3 groups according to the time between last MI and ICD implant: [1] from 40 days to less than 1.5 years; [2] from 1.5 to less than 7 years and [3] at least 7 years. Results The cumulative incidence of ventricular tachyarrhymias and appropriate device therapy (ATP or shock) were higher in patients implanted longer time from last MI (Gray’s Test p = 0.002 and p = 0.013 respectively). No significant differences were seen in all cause mortality (Gray’s Test p = 0.618) or sudden cardiac death across the MI stratification groups (Gray’s Test p = 0.663). Conclusions Patients implanted with an ICD longer after the MI have a higher chance of presenting ventricular tachyarrhythmias and appropriate ICD therapy, while no differences were seen in overall mortality. These observations may be important for improving patient targeting in sudden death prevention. PMID:22966862

Generator replacement is associated with an increased rate of ICD lead alerts.

PubMed

Lovelock, Joshua D; Cruz, Cesar; Hoskins, Michael H; Jones, Paul; El-Chami, Mikhael F; Lloyd, Michael S; Leon, Angel; DeLurgio, David B; Langberg, Jonathan J

2014-10-01

Lead malfunction is an important cause of morbidity and mortality in patients with an implantable cardioverter-defibrillator (ICD). We have shown that the failure of recalled high-voltage leads significantly increases after ICD generator replacement. However, generator replacement has not been recognized as a predictor of lead failure in general. The purpose of this study is to assess the effect of ICD generator exchange on the rate of ICD lead alerts. A time-dependent Cox proportional hazards model was used to analyze a database of remotely monitored ICDs. The model assessed the impact of generator exchange on the rate of lead alerts after ICD generator replacement. The analysis included 60,219 patients followed for 37 ± 19 months. The 5-year lead survival was 99.3% (95% confidence interval 99.2%-99.4%). Of 60,219 patients, 7458 patients (12.9%) underwent ICD generator exchange without lead replacement. After generator replacement, the rate of lead alerts was more than 5-fold higher than in controls with leads of the same age without generator replacement (hazard ratio 5.19; 95% confidence interval 3.45-7.84). A large number of lead alerted within 3 months of generator replacement. Lead alerts were more common in patients with single- vs dual-chamber ICDs and in younger patients. Sex was not associated with lead alerts. Routine generator replacement is associated with a 5-fold higher risk of lead alert compared to age-matched leads without generator replacement. This suggests the need for intense surveillance after generator replacement and the development of techniques to minimize the risk of lead damage during generator replacement. Copyright © 2014 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Initial experience of subcutaneous implantable cardioverter defibrillators in Singapore: a case series and review of the literature

PubMed Central

Lim, Tien Siang Eric; Tan, Boon Yew; Ho, Kah Leng; Lim, Chuh Yih Paul; Teo, Wee Siong; Ching, Chi-Keong

2015-01-01

Transvenous implantable cardioverter defibrillators are a type of implantable cardiac device. They are effective at reducing total and arrhythmic mortality in patients at risk of sudden cardiac death. Subcutaneous implantable cardioverter defibrillators (S-ICDs) are a new alternative that avoids the disadvantages of transvenous lead placement. In this case series, we report on the initial feasibility and safety of S-ICD implantation in Singapore. PMID:26512151

Initial experience of subcutaneous implantable cardioverter defibrillators in Singapore: a case series and review of the literature.

PubMed

Lim, Tien Siang Eric; Tan, Boon Yew; Ho, Kah Leng; Lim, Chuh Yih Paul; Teo, Wee Siong; Ching, Chi-Keong

2015-10-01

Transvenous implantable cardioverter defibrillators are a type of implantable cardiac device. They are effective at reducing total and arrhythmic mortality in patients at risk of sudden cardiac death. Subcutaneous implantable cardioverter defibrillators (S-ICDs) are a new alternative that avoids the disadvantages of transvenous lead placement. In this case series, we report on the initial feasibility and safety of S-ICD implantation in Singapore.

Association of Single vs. Dual Chamber ICDs with Mortality, Readmissions and Complications among Patients Receiving an ICD for Primary Prevention

PubMed Central

Peterson, Pamela N; Varosy, Paul D; Heidenreich, Paul A; Wang, Yongfei; Dewland, Thomas A; Curtis, Jeptha P; Go, Alan S; Greenlee, Robert T; Magid, David J; Normand, Sharon-Lise T; Masoudi, Frederick A

2013-01-01

Importance Randomized trials of implantable cardioverter defibrillators (ICDs) for primary prevention predominantly employed single chamber devices. In clinical practice, patients often receive dual chamber ICDs, even without clear indications for pacing. The outcomes of dual versus single chamber devices are uncertain. Objective Compare outcomes of single and dual chamber ICDs for primary prevention of sudden cardiac death. Design, Setting, and Participants Retrospective cohort study. Admissions in the National Cardiovascular Data Registry’s (NCDR®) ICD Registry™ from 2006–2009 that could be linked to CMS fee for service Medicare claims data were identified. Patients were included if they received an ICD for primary prevention and did not have a documented indication for pacing. Main Outcome Measures Adjusted risks of 1-year mortality, all-cause readmission, HF readmission and device-related complications within 90 days were estimated with propensity-score matching based on patient, clinician and hospital factors. Results Among 32,034 patients, 38% (n=12,246) received a single chamber device and 62% (n=19,788) received a dual chamber device. In a propensity-matched cohort, rates of complications were lower for single chamber devices (3.5% vs. 4.7%; p<0.001; risk difference −1.20; 95% CI −1.72, −0.69), but device type was not significantly associated with mortality or hospitalization outcomes (unadjusted rate 9.9% vs. 9.8%; HR 0.99, 95% CI 0.91–1.07; p=0.792 for 1-year mortality; unadjusted rate 43.9% vs. 44.8%; HR 1.00, 95% CI 0.97–1.04; p=0.821 for 1-year all-cause hospitalization; unadjusted rate 14.7% vs. 15.4%; HR 1.05, 95% CI 0.99–1.12; p=0.189 for 1-year HF hospitalization). Conclusions and Relevance Among patients receiving an ICD for primary prevention without indications for pacing, the use of a dual chamber device compared with a single chamber device was associated with a higher risk of device-related complications but not with

Deactivation of implantable cardioverter defibrillators in terminal illness and end of life care.

PubMed

Kirkpatrick, James N; Gottlieb, Maia; Sehgal, Priya; Patel, Rutuke; Verdino, Ralph J

2012-01-01

Cardiology professional societies have recommended that patients with cardiovascular implantable electronic devices complete advance directives (ADs). However, physicians rarely discuss end of life handling of implantable cardioverter defibrillators (ICDs), and standard AD forms do not address the presence of ICDs. We conducted a telephone survey of 278 patients with an ICD from a large, academic hospital. The average period since implantation was 5.15 years. More than 1/3 (38%) had been shocked, with a mean of 4.69 shocks. More than 1/2 had executed an AD, but only 3 had included a plan for their ICD. Most subjects (86%) had never considered what to do with their ICD if they had a serious illness and were unlikely to survive. When asked about ICD deactivation in an end of life situation, 42% said it would depend, 28% favored deactivation, and 11% would not deactivate. One quarter (26%) thought ICD deactivation was a form of assisted suicide, 22% thought a do not resuscitate order did not mean that the ICD should be deactivated, and 46% responded that the ICD should not be automatically deactivated in hospice. The answers did not correlate with any demographic factors. Almost all (95%) agreed that patients should have the opportunity to execute an AD that directs handing of an ICD. When asked who should be responsible for discussing this device for an AD, 31% said electrophysiologists, 45% said general cardiologists, and 14% said primary care physicians. In conclusion, the results of the present study highlight the lack of consensus among patients with an ICD on the issue of deactivation at the end of a patient's life. These findings suggest cardiologists should discuss end of life care and device deactivation with their patients with an ICD. Copyright © 2012 Elsevier Inc. All rights reserved.

Risk Stratification in Arrhythmic Right Ventricular Cardiomyopathy Without Implantable Cardioverter-Defibrillators

PubMed Central

Brun, Francesca; Groeneweg, Judith A.; Gear, Kathleen; Sinagra, Gianfranco; van der Heijden, Jeroen; Mestroni, Luisa; Hauer, Richard N.; Borgstrom, Mark; Marcus, Frank I.; Hughes, Trina

2016-01-01

Objectives The primary objective of this study is risk stratification of patients with arrhythmic right ventricular cardiomyopathy (ARVC). Background There is a need to identify those who need an automatic implantable defibrillator (ICD) to prevent sudden death. Methods This is an analysis of 88 patients with ARVC from three centers who were not treated with an ICD. Results Risk factors for subsequent arrhythmic deaths were pre-enrollment sustained or nonsustained ventricular tachycardia (VT) and decreased left ventricular function. Conclusion These factors serve as proposed guidelines for implantation of an ICD in patients with ARVC to prevent sudden death. PMID:27790640

Utilization trends and clinical outcomes in patients implanted with a single- vs a dual-coil implantable cardioverter-defibrillator lead: Insights from the ALTITUDE Study.

PubMed

Hsu, Jonathan C; Saxon, Leslie A; Jones, Paul W; Wehrenberg, Scott; Marcus, Gregory M

2015-08-01

Historically, the most commonly implanted implantable cardioverter-defibrillator (ICD) lead is dual coil. Conventional wisdom holds that single-coil leads may be less effective than dual-coil leads, but easier to extract. No contemporary large-scale studies have evaluated the relative epidemiology of these 2 leads or compared their respective clinical outcomes. We sought to evaluate trends in single- vs dual-coil ICD lead implantation and differences in clinical outcomes. We evaluated 129,520 ICD recipients enrolled in the LATITUDE remote monitoring system between 2004 and 2014. Kaplan-Meier analyses and Cox proportional hazards regression analyses were used for univariate and multivariate survival analysis, respectively. The majority of ICD recipients received a dual-coil lead (n = 110,330 [85.2%]). Single-coil lead implantation increased from 1.9% to 55.2% between 2004 and 2014. After adjusting for age, sex, device type, and year of implant, single-coil lead implantation was associated with a greater odds of induction for defibrillation testing (odds ratio 1.05; 95% confidence interval [CI] 1.01-1.09; P = .0274), a higher rate of lead being taken out of service (hazard ratio 1.19; 95% CI 1.06-1.33; P = .0032), and a decreased mortality rate (hazard ratio 0.91; 95% CI 0.87-0.96; P = .0004). In a 795 patient subset with adjudicated shock outcomes, first shock success was no different (87.0% in single coil vs 86.1% in dual coil; P = .8473). In a large real-world US population, single-coil lead implantation rates increased substantially between 2004 and 2014. Single-coil lead implantation was associated with more frequent defibrillation testing and the lead being taken out of service, but was not associated with increased mortality or more frequent defibrillation failure. Copyright © 2015 Heart Rhythm Society. All rights reserved.

Conducting Retrospective Ontological Clinical Trials in ICD-9-CM in the Age of ICD-10-CM.

PubMed

Venepalli, Neeta K; Shergill, Ardaman; Dorestani, Parvaneh; Boyd, Andrew D

2014-01-01

To quantify the impact of International Classification of Disease 10th Revision Clinical Modification (ICD-10-CM) transition in cancer clinical trials by comparing coding accuracy and data discontinuity in backward ICD-10-CM to ICD-9-CM mapping via two tools, and to develop a standard ICD-9-CM and ICD-10-CM bridging methodology for retrospective analyses. While the transition to ICD-10-CM has been delayed until October 2015, its impact on cancer-related studies utilizing ICD-9-CM diagnoses has been inadequately explored. Three high impact journals with broad national and international readerships were reviewed for cancer-related studies utilizing ICD-9-CM diagnoses codes in study design, methods, or results. Forward ICD-9-CM to ICD-10-CM mapping was performing using a translational methodology with the Motif web portal ICD-9-CM conversion tool. Backward mapping from ICD-10-CM to ICD-9-CM was performed using both Centers for Medicare and Medicaid Services (CMS) general equivalence mappings (GEMs) files and the Motif web portal tool. Generated ICD-9-CM codes were compared with the original ICD-9-CM codes to assess data accuracy and discontinuity. While both methods yielded additional ICD-9-CM codes, the CMS GEMs method provided incomplete coverage with 16 of the original ICD-9-CM codes missing, whereas the Motif web portal method provided complete coverage. Of these 16 codes, 12 ICD-9-CM codes were present in 2010 Illinois Medicaid data, and accounted for 0.52% of patient encounters and 0.35% of total Medicaid reimbursements. Extraneous ICD-9-CM codes from both methods (Centers for Medicare and Medicaid Services general equivalent mapping [CMS GEMs, n = 161; Motif web portal, n = 246]) in excess of original ICD-9-CM codes accounted for 2.1% and 2.3% of total patient encounters and 3.4% and 4.1% of total Medicaid reimbursements from the 2010 Illinois Medicare database. Longitudinal data analyses post-ICD-10-CM transition will require backward ICD-10-CM to ICD-9-CM

Thirteen-year nationwide trends in use of implantable cardioverter-defibrillators and subsequent long-term survival.

PubMed

Schmidt, Morten; Pedersen, Susanne Bendesgaard; Farkas, Dóra Körmendiné; Hjortshøj, Søren Pihlkjær; Bøtker, Hans Erik; Nielsen, Jens Cosedis; Sørensen, Henrik Toft

2015-09-01

Long-term trends in use of implantable cardioverter-defibrillators (ICDs) and outcomes are rare. We examined 13-year nationwide trends in ICD implantation and survival rates in Denmark. Using medical databases, we identified all first time ICD recipients in Denmark during 2000-2012 (N = 8460) and ascertained all-cause mortality. We computed standardized annual implantation rates and mortality rate ratios according to age, sex, comorbidity level, indication, and device type. The standardized annual implantation rate increased from 42 per million persons in 2000 to 213 per million persons in 2012 (from 34 to 174 for men and from 8 to 39 for women). The increase was driven by secondary prophylactic ICDs until 2006 and primary prophylactic ICDs thereafter. The increase occurred particularly in older patients and those with a high level of comorbidity. Independent of indication, 76% of all patients with ICD were alive after 5 years. Men had a higher mortality rate compared with women (mortality rate ratio 1.28; 95% confidence interval 1.10-1.49). Compared with low comorbidity level, moderate, severe, and very severe comorbidity levels were associated with 1.6-, 2.5-, and 4.9-fold increased mortality rates, respectively. The most influential individual comorbidities were heart failure, diabetes, liver disease, and renal disease. The annual implantation rate of ICDs increased 5-fold in Denmark between 2000 and 2012. The rate increase occurred for both men and women, but particularly in the elderly and patients with severe comorbidity. Five-year survival probability was high, but severe comorbidity and male sex were associated with shorter survival. Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

SU-E-T-169: Characterization of Pacemaker/ICD Dose in SAVI HDR Brachytherapy

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

Kalavagunta, C; Lasio, G; Yi, B

2015-06-15

Purpose: It is important to estimate dose to pacemaker (PM)/Implantable Cardioverter Defibrillator (ICD) before undertaking Accelerated Partial Breast Treatment using High Dose Rate (HDR) brachytherapy. Kim et al. have reported HDR PM/ICD dose using a single-source balloon applicator. To the authors knowledge, there have so far not been any published PM/ICD dosimetry literature for the Strut Adjusted Volume Implant (SAVI, Cianna Medical, Aliso Viejo, CA). This study aims to fill this gap by generating a dose look up table (LUT) to predict maximum dose to the PM/ICD in SAVI HDR brachytherapy. Methods: CT scans for 3D dosimetric planning were acquiredmore » for four SAVI applicators (6−1-mini, 6−1, 8−1 and 10−1) expanded to their maximum diameter in air. The CT datasets were imported into the Elekta Oncentra TPS for planning and each applicator was digitized in a multiplanar reconstruction window. A dose of 340 cGy was prescribed to the surface of a 1 cm expansion of the SAVI applicator cavity. Cartesian coordinates of the digitized applicator were determined in the treatment leading to the generation of a dose distribution and corresponding distance-dose prediction look up table (LUT) for distances from 2 to 15 cm (6-mini) and 2 to 20 cm (10–1).The deviation between the LUT doses and the dose to the cardiac device in a clinical case was evaluated. Results: Distance-dose look up table were compared to clinical SAVI plan and the discrepancy between the max dose predicted by the LUT and the clinical plan was found to be in the range (−0.44%, 0.74%) of the prescription dose. Conclusion: The distance-dose look up tables for SAVI applicators can be used to estimate the maximum dose to the ICD/PM, with a potential usefulness for quick assessment of dose to the cardiac device prior to applicator placement.« less

Proportion of patients needing an implantable cardioverter defibrillator on the basis of current guidelines: impact on healthcare resources in Italy and the USA. Data from the ALPHA study registry.

PubMed

Pedretti, Roberto F E; Curnis, Antonio; Massa, Riccardo; Morandi, Fabrizio; Tritto, Massimo; Manca, Lorenzo; Occhetta, Eraldo; Molon, Giulio; De Ferrari, Gaetano M; Sarzi Braga, Simona; Raciti, Giovanni; Klersy, Catherine; Salerno-Uriarte, Jorge A

2010-08-01

Implantable cardioverter defibrillators (ICD) improve survival in selected patients with left ventricular dysfunction or heart failure (HF). The objective is to estimate the number of ICD candidates and to assess the potential impact on public health expenditure in Italy and the USA. Data from 3513 consecutive patients (ALPHA study registry) were screened. A model based on international guidelines inclusion criteria and epidemiological data was used to estimate the number of eligible patients. A comparison with current ICD implant rate was done to estimate the necessary incremental rate to treat eligible patients within 5 years. Up to 54% of HF patients are estimated to be eligible for ICD implantation. An implantation policy based on guidelines would significantly increase the ICD number to 2671 implants per million inhabitants in Italy and to 4261 in the USA. An annual increment of prophylactic ICD implants of 20% in the USA and 68% in Italy would be necessary to treat all indicated patients in a 5-year timeframe. Implantable cardioverter defibrillator implantation policy based on current evidence may have significant impact on public health expenditure. Effective risk stratification may be useful in order to maximize benefit of ICD therapy and its cost-effectiveness in primary prevention.

Battery longevity in cardiac resynchronization therapy implantable cardioverter defibrillators.

PubMed

Alam, Mian Bilal; Munir, Muhammad Bilal; Rattan, Rohit; Flanigan, Susan; Adelstein, Evan; Jain, Sandeep; Saba, Samir

2014-02-01

Cardiac resynchronization therapy (CRT) implantable cardioverter defibrillators (ICDs) deliver high burden ventricular pacing to heart failure patients, which has a significant effect on battery longevity. The aim of this study was to investigate whether battery longevity is comparable for CRT-ICDs from different manufacturers in a contemporary cohort of patients. All the CRT-ICDs implanted at our institution from 1 January 2008 to 31 December 2010 were included in this analysis. Baseline demographic and clinical data were collected on all patients using the electronic medical record. Detailed device information was collected on all patients from scanned device printouts obtained during routine follow-up. The primary endpoint was device replacement for battery reaching the elective replacement indicator (ERI). A total of 646 patients (age 69 ± 13 years), implanted with CRT-ICDs (Boston Scientific 173, Medtronic 416, and St Jude Medical 57) were included in this analysis. During 2.7 ± 1.5 years follow-up, 113 (17%) devices had reached ERI (Boston scientific 4%, Medtronic 25%, and St Jude Medical 7%, P < 0.001). The 4-year survival rate of device battery was significantly worse for Medtronic devices compared with devices from other manufacturers (94% for Boston scientific, 67% for Medtronic, and 92% for St Jude Medical, P < 0.001). The difference in battery longevity by manufacturer was independent of pacing burden, lead parameters, and burden of ICD therapy. There are significant discrepancies in CRT-ICD battery longevity by manufacturer. These data have important implications on clinical practice and patient outcomes.

Wideband Arrhythmia-Insensitive-Rapid (AIR) Pulse Sequence for Cardiac T1 mapping without Image Artifacts induced by ICD

PubMed Central

Hong, KyungPyo; Jeong, Eun-Kee; Wall, T. Scott; Drakos, Stavros G.; Kim, Daniel

2015-01-01

Purpose To develop and evaluate a wideband arrhythmia-insensitive-rapid (AIR) pulse sequence for cardiac T1 mapping without image artifacts induced by implantable-cardioverter-defibrillator (ICD). Methods We developed a wideband AIR pulse sequence by incorporating a saturation pulse with wide frequency bandwidth (8.9 kHz), in order to achieve uniform T1 weighting in the heart with ICD. We tested the performance of original and “wideband” AIR cardiac T1 mapping pulse sequences in phantom and human experiments at 1.5T. Results In 5 phantoms representing native myocardium and blood and post-contrast blood/tissue T1 values, compared with the control T1 values measured with an inversion-recovery pulse sequence without ICD, T1 values measured with original AIR with ICD were considerably lower (absolute percent error >29%), whereas T1 values measured with wideband AIR with ICD were similar (absolute percent error <5%). Similarly, in 11 human subjects, compared with the control T1 values measured with original AIR without ICD, T1 measured with original AIR with ICD was significantly lower (absolute percent error >10.1%), whereas T1 measured with wideband AIR with ICD was similar (absolute percent error <2.0%). Conclusion This study demonstrates the feasibility of a wideband pulse sequence for cardiac T1 mapping without significant image artifacts induced by ICD. PMID:25975192

Implantable cardioverter defibrillators in the context of hypertrophic cardiomyopathy: a lesson in patient autonomy.

PubMed

Bray, Jonathan James Hyett; Bucciarelli-Ducci, Chiara; Stuart, Graham

2018-02-05

Hypertrophiccardiomyopathy (HCM) is common, whereas the decision not to have an implantable cardioverterdefibrillator (ICD) when probably falling into a 'high-risk' category is not. A solicitor aged 45 years attended the inherited cardiac conditions clinic for review of her HCM and discussion about ICD implantation for primary prevention of sudden cardiac death (SCD). Despite a predicted 7% risk of SCD within the next 5 years, according to the European Society of Cardiology endorsed HCM Risk-SCD risk stratification tool, the patient opted against implantation of an ICD and comprehensively justifies her decision. This report discusses ethical aspects of a consultation offering ICD protection against SCD in the context of HCM and emphasises the clinicians' role in respecting patient autonomy. © BMJ Publishing Group Ltd (unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Classic conditioning and dysfunctional cognitions in patients with panic disorder and agoraphobia treated with an implantable cardioverter/defibrillator.

PubMed

Godemann, F; Ahrens, B; Behrens, S; Berthold, R; Gandor, C; Lampe, F; Linden, M

2001-01-01

A model for the development of anxiety disorders (panic disorder with or without agoraphobia) is needed. Patients with an implantable cardioverter/defibrillator (ICD) are exposed to repeated electric shocks. If the theory of anxiety development by aversive classic conditioning processes is valid, these repeated shocks should lead to an increased risk of anxiety disorders. To study this hypothesis, we retrospectively studied 72 patients after implantation of an automatic ICD. Patients were assessed with the semistructured Diagnostic Interview of Psychiatric Disease 1 to 6 years after implantation of an automatic ICD. Panic disorder and/or agoraphobia was diagnosed in patients who fulfilled all DSM-III-R criteria for those conditions. Anxiety disorder developed in 15.9% of patients after ICD implantation. This was significantly related to the frequency of repeated defibrillation (shocks) to stop malignant ventricular arrhythmias. Dysfunctional cognitions are an additional vulnerability factor. The data support both the conditioning hypothesis and the cognitive model of anxiety development. These findings suggest that ICD patients are an appropriate risk population for a prospective study of the development of anxiety disorders.

Life-saving implantable cardioverter defibrillator therapy in cardiac AL amyloidosis

PubMed Central

Patel, Ketna S; Hawkins, Philip N; Whelan, Carol J; Gillmore, Julian D

2014-01-01

Cardiac involvement is the main determinant of prognosis in systemic monoclonal immunoglobulin light chain (AL) amyloidosis. Ventricular arrhythmias and sudden cardiac death are not uncommon. The electrical events that precede sudden death, and their potential to be treated effectively, remain undefined. There are no European guidelines for the use of implantable cardioverter defibrillator (ICD) in amyloidosis. ICDs in general are not usually offered to patients with a life expectancy of less than 1 year. We describe a patient who presented with cardiac AL amyloidosis who underwent prophylactic ICD implantation for the prevention of sudden cardiac death during treatment with chemotherapy, in whom life-threatening ventricular arrhythmia was successfully terminated over a 3-year period. PMID:25535224

"Real life" longevity of implantable cardioverter-defibrillator devices.

PubMed

Manolis, Antonis S; Maounis, Themistoklis; Koulouris, Spyridon; Vassilikos, Vassilios

2017-09-01

Manufacturers of implantable cardioverter-defibrillators (ICDs) promise a 5- to 9-year projected longevity; however, real-life data indicate otherwise. The aim of the present study was to assess ICD longevity among 685 consecutive patients over the last 20 years. Real-life longevity of ICDs may differ from that stated by the manufacturers. The study included 601 men and 84 women (mean age, 63.1 ± 13.3 years). The underlying disease was coronary (n = 396) or valvular (n = 15) disease, cardiomyopathy (n = 220), or electrical disease (n = 54). The mean ejection fraction was 35%. Devices were implanted for secondary (n = 562) or primary (n = 123) prevention. Single- (n = 292) or dual-chamber (n = 269) or cardiac resynchronization therapy (CRT) devices (n = 124) were implanted in the abdomen (n = 17) or chest (n = 668). Over 20 years, ICD pulse generator replacements were performed in 238 patients (209 men; age 63.7 ± 13.9 years; ejection fraction, 37.7% ± 14.0%) who had an ICD for secondary (n = 210) or primary (n = 28) prevention. The mean ICD longevity was 58.3 ± 18.7 months. In 20 (8.4%) patients, devices exhibited premature battery depletion within 36 months. Most (94%) patients had none, minor, or modest use of ICD therapy. Longevity was longest for single-chamber devices and shortest for CRT devices. Latest-generation devices replaced over the second decade lasted longer compared with devices replaced during the first decade. When analyzed by manufacturer, Medtronic devices appeared to have longer longevity by 13 to 18 months. ICDs continue to have limited longevity of 4.9 ± 1.6 years, and 8% demonstrate premature battery depletion by 3 years. CRT devices have the shortest longevity (mean, 3.8 years) by 13 to 17 months, compared with other ICD devices. These findings have important implications, particularly in view of the high expense involved with this type of electrical

Clinical safety of an MRI conditional implantable cardioverter defibrillator system: A prospective Monocenter ICD-Magnetic resonance Imaging feasibility study (MIMI).

PubMed

Kypta, Alexander; Blessberger, Hermann; Hoenig, Simon; Saleh, Karim; Lambert, Thomas; Kammler, Juergen; Fellner, Franz; Lichtenauer, Michael; Steinwender, Clemens

2016-03-01

The aim of this study was to evaluate the safety and efficacy of the Lumax 740(®) Implantable Cardioverter Defibrillator (ICD) system in patients undergoing a defined 1.5 Tesla (T) MRI. Between November 2013 and April 2014, eighteen patients (age range, 41-78 years; mean age, 64 years) implanted with a Lumax 740(®) ICD system for at least 6 weeks before an MRI were enrolled into this single-center feasibility study. The local ethics committee approved the study before patients gave written informed consent. Patients underwent defined MRI 1.5T of the brain and lower lumbar spine with three safety follow-up evaluations obtained during the 3-month study period. Data were analyzed descriptively. Study endpoints were the absence of either MRI and pacing system related serious adverse device effects (SADE), or of a ventricular pacing threshold increase >0.5V, or of an R-wave amplitude attenuation < 50%, or of an R-wave amplitude < 5.0 mV at 1-month follow-up. The assessment of safety and efficacy was supported by recording of all adverse events, changes in pacing threshold, R-wave sensing, pacing impedances and in battery status. Sixteen patients completed the MRI and the follow-up period. As no SADE occurred, the SADE free rate was 100%. Freedom from ventricular pacing threshold increase was 100% (16/16; 95%CI: 82.9%; 100.0%). There were no significant differences between baseline and follow-up measurements of sensing amplitudes (-0.58 ± 2.07 mV, P = 0.239, -0.41 ± 1.04 mV, P = 0.133, and -0.25 ± 1.36 mV, P = 0.724, for immediately after, 1 month and 3 months after MRI scan, respectively) and pacing thresholds (-0.047 ± 0.18 V, P = 0.317, -0.019 ± 0.11 V, P = 0.490, and 0.075 ± 0.19 V, P = 0.070, for immediately after, 1 month and 3 months after MRI scan, respectively). Lead impedances after the MRI scan were significantly lower as compared with baseline values (-22.8 ± 21.69 Ω, P = 0

Implanted near-infrared spectroscopy for cardiac monitoring

NASA Astrophysics Data System (ADS)

Bhunia, Sourav K.; Cinbis, Can

2011-02-01

Implanted Cardioverter Defibrillator (ICD) provides one of the most effective therapies for the prevention of sudden cardiac death, but also delivers some high voltage shocks inappropriately, causing morbidity and mortality. Implanted near-infrared spectroscopy (NIRS) may augment ICD arrhythmia detection by monitoring skeletal muscle perfusion. A two-wavelength, single-distance, continuous-wave implanted NIRS has been evaluated in-vivo. A weighted difference of the changes in attenuation at two wavelengths, across the isobestic point of the hemoglobin spectra, was taken to be the microvascular oxygenation trend indicator (O2 Index). Although the exact weight depends on the local vascular distribution and their oxygen levels, the hypothesis that a constant weight may be adequate for hemodynamic trending during short arrhythmic episodes, was tested. The sensor was implanted subcutaneously both on fresh tissue and inside scar tissue that formed around a pre-existing implant, in 3 animals each. Attenuations were recorded at 660 and 890 nm during normal sinus rhythm (NSR) and induced ventricular fibrillation (VF). The slope of the O2 Index over 10 seconds was computed for 7 NSR and 8 VF episodes in fresh and 13 NSR and 15 VF episodes in scar tissue pockets. The mean O2 Index slope was significantly different (p<0.0001) between NSR and VF rhythms for both the fresh and scar tissue pockets. Therefore implanted NIRS may be useful for preventing inappropriate detection of VF during electromagnetic interference, double counting of ECG T-wave as an R-wave, ICD lead failure, electrocardiographic aberrancy etc.

The Role of Conventional and Right-Sided ECG Screening for Subcutaneous ICD in a Tetralogy of Fallot Population.

PubMed

Alonso, Pau; Osca, Joaquín; Cano, Oscar; Pimenta, Pedro; Andrés, Ana; Yagüe, Jaime; Millet, José; Rueda, Joaquín; Sancho-Tello, María José

2017-02-01

Information regarding suitability for subcutaneous implantable cardioverter-defibrillator (S-ICD) implant in tetralogy of Fallot (ToF) population is scarce and needs to be further explored. (1) to determine the proportion of patients with ToF eligible for S-ICD, (2) to identify the optimal sensing vector in ToF patients, (3) to test specifically the eligibility for S-ICD with right-sided screening, and (4) to compare with the proportion of eligible patients in a nonselected ICD population. We recruited 60 consecutive patients with ToF and 40 consecutive nonselected patients. Conventional electrocardiographic screening was performed as usual. Right-sided alternative screening was studied by positioning the left arm and right arm electrodes 1 cm right lateral to the xiphoid midline. The Boston Scientific electrocardiogram (ECG) screening tool was utilized. We found a higher proportion of patients with right-sided positive screening in comparison with standard screening (77 ± 0.4% vs. 67 ± 0.4%; P < 0.0001) and a trend to higher number of appropriate leads in right-sided screening (1.3 ± 1 vs. 1.1 ± 1 ms; P = 0.07). Patients who failed the screening had a longer QRS duration and longer QT interval. Standard and right-sided screening showed a higher percent of positive patients in the control group compared to ToF patients (P < 0.001). Right-sided screening was associated with a significant 10% increase in S-ICD eligibility in ToF patients. When comparing with an acquired cardiomyopathies group, ToF showed a lower eligibility for S-ICD. The most appropriate ECG vector was the alternate vector in contrast to what is observed in the general population. © 2017 Wiley Periodicals, Inc.

Relation between total shock energy and mortality in patients with implantable cardioverter-defibrillator.

PubMed

Tenma, Taro; Yokoshiki, Hisashi; Mitsuyama, Hirofumi; Watanabe, Masaya; Mizukami, Kazuya; Kamada, Rui; Takahashi, Masayuki; Sasaki, Ryo; Maeno, Motoki; Okamoto, Kaori; Chiba, Yuki; Anzai, Toshihisa

2018-05-15

Implantable Cardioverter-Defibrillator (ICD) shocks have been associated with mortality. However, no study has examined the relation between total shock energy and mortality. The aim of this study is to assess the association of total shock energy with mortality, and to determine the patients who are at risk of this association. Data from 316 consecutive patients who underwent initial ICD implantation in our hospital between 2000 and 2011 were retrospectively studied. We collected shock energy for 3 years from the ICD implantation, and determined the relation of shock energy on mortality after adjusting confounding factors. Eighty-seven ICD recipients experienced shock(s) within 3 years from ICD implantation and 43 patients had died during the follow-up. The amount of shock energy was significantly associated with all-cause death [adjusted hazard ratio (HR) 1.26 (per 100 joule increase), p < 0.01] and tended to be associated with cardiac death (adjusted HR 1.30, p = 0.08). The survival rate of patients with high shock energy accumulation (≥182 joule) was lower (p < 0.05), as compared to low shock energy accumulation (<182 joule), likewise to no shock. Besides, the relation between high shock energy accumulation and all-cause death was remarkable in the patients with low left ventricular ejection fraction (LVEF ≤40%) or atrial fibrillation (AF). Increase of shock energy was related to mortality in ICD recipients. This relation was evident in patients with low LVEF or AF. Copyright © 2018 Elsevier B.V. All rights reserved.

Implantable intravascular defibrillator: defibrillation thresholds of an intravascular cardioverter-defibrillator compared with those of a conventional ICD in humans.

PubMed

Neuzil, Petr; Reddy, Vivek Y; Merkely, Bela; Geller, Laszlo; Molnar, Levente; Bednarek, Jacek; Bartus, Krzysztof; Richey, Mark; Bsee, T J Ransbury; Sanders, William E

2014-02-01

A percutaneous intravascular cardioverter-defibrillator (PICD) has been developed with a right ventricular (RV) single-coil lead and titanium electrodes in the superior vena cava (SVC)-brachiocephalic vein (BCV) region and the inferior vena cava (IVC). To compare defibrillation thresholds (DFTs) of the PICD with those of a conventional ICD in humans. Ten patients with ischemic cardiomyopathy and ejection fraction ≤35% were randomized to initial testing with either PICD or conventional ICD. A standard dual-coil lead was positioned in the RV apex. If randomized to PICD, the device was placed into the vasculature such that 1 titanium electrode was positioned in the SVC-BCV region and the second in the IVC. For PICD DFTs, the RV coil of the conventional ICD lead was connected to the PICD mandrel [shock vector: RV (+) to SVC-BCV (-) + IVC (-)]. When testing the conventional ICD, a subcutaneous pocket was formed in the left pectoralis region and the ICD was connected to the lead system and positioned in the pocket [shock vector: RV (+) to SVC (-) + active can (-)]. Each device was removed before testing with the other. A step-down binary search protocol determined the DFT, with the initial shock being 9 J. The mean PICD DFT was 7.6 ± 3.3 J, and the conventional ICD system demonstrated a mean DFT of 9.5 ± 4.7 J (N = 10; paired t test, P = .28). The intravascular defibrillator has DFTs similar to those of commercially available ICDs. Published by Heart Rhythm Society on behalf of Heart Rhythm Society.

An inappropriate pacing threshold increase after repeated electrical storm in a patient with implantable cardioverter defibrillator.

PubMed

Zhu, Ye; Gu, Xiang; Xu, Chao

2017-10-16

Implantable cardioverter defibrillators (ICD) are capable of effectively terminating malignant ventricular arrhythmia and are the most effective way to prevent sudden cardiac death. However, some evidences demonstrated that both anti-tachycardia pacing (ATP) and ICD shock can also bring adverse prognosis. A 66-year-old Han Chinese man with prior ICD implantation was admitted to our hospital because of frequent ICD shocks. Although intravenous amiodarone and esmolol succinate were administered daily, the patient suffered 155 episodes of VT/VF during 8 weeks after implantation. After repeated discharge of the device, the pacing threshold of the patient increased gradually. Considering the inappropriate increase of the pacing threshold, we decided to reposition the right ventricular (RV) lead with good sensing and threshold parameters confirmed. Subsequent 22 months interrogation follow-up revealed a stable lead position and electrical specifications. Furthermore, antiarrhythmic drugs were maximally increased, while ATP burst was remarkably decreased and the inappropriate ICD shock never occurred until now. An inappropriate pacing threshold was increased secondary to repeated ICD electrical storm. A timely active lead position adjustment reduced the pacing threshold and eliminated the risk of premature battery depletion.

Relationship between age and inappropriate implantable cardioverter-defibrillator therapy in MADIT-RIT (Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy).

PubMed

Biton, Yitschak; Huang, David T; Goldenberg, Ilan; Rosero, Spencer; Moss, Arthur J; Kutyifa, Valentina; McNitt, Scott; Strasberg, Boris; Zareba, Wojciech; Barsheshet, Alon

2016-04-01

There is limited data regarding the relationship between age and inappropriate therapy among patients with an implantable cardioverter-defibrillator (ICD) and resynchronization therapy. We aimed to investigate this relationship and the effect of ICD programming on inappropriate therapy by age. In the Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT) 1500 patients were randomized to 3 ICD programming arms: (A) conventional with ventricular tachycardia (VT) therapy ≥170; (B) high-rate cutoff with VT therapy ≥200, and (C) prolonged 60-second delay for VT therapy ≥170. We investigated the relationship between age, the risk of inappropriate ICD therapy (including antitachycardia pacing [ATP] or shock), and ICD programming. Cumulative incidence function Kaplan-Meier graphs showed an inverse relationship between increasing quartiles of age (Q1: ≤55, Q2: 56-64, Q3: 65-71, and Q4: ≥72 years) and the risk for inappropriate therapy. Multivariate analyses showed that each increasing decade of life was associated with 34% (P < .001), 27% (P < .001), and 26% (P < .001) reduction in the risk of inappropriate shock, inappropriate ATP, and any inappropriate therapy, respectively. Treatment arms B and C as compared with arm A were associated with a significant reduction in the risk of inappropriate therapies across all age quartiles (P < .001 for all). Among patients with a primary prevention indication for an ICD, there is an inverse relationship between age and inappropriate ICD therapy. Innovative ICD programming of high-rate cutoff or prolonged delay for VT therapy is associated with significant reductions in inappropriate therapy among all age groups. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Defibrillation testing in everyday medical practice during implantable cardioverter defibrillator implantation in France: analysis from the LEADER registry.

PubMed

Sadoul, Nicolas; Defaye, Pascal; Mouton, Elisabeth; Bizeau, Olivier; Dupuis, Jean-Marc; Blangy, Hugues; Delarche, Nicolas; Blanc, Jean-Jacques; Lazarus, Arnaud

2013-11-01

Defibrillation testing (DT) is usually performed during implantable cardioverter defibrillator (ICD) implantation. We conducted a multicentre prospective study to determine the DT procedures used in everyday practice, to compare the characteristics of patients with or without DT, and to compare severe adverse events in these two populations during implantation and follow-up. The LEADER registry enrolled 904 patients included for primo-implantation of a single (n=261), dual (n=230) or triple (n=429) defibrillation system in 42 French centres. Baseline characteristics of patients (62.0 ± 13.5 years; 88% men; primary indication 62%) who underwent ventricular fibrillation (VF) induction (VF induction group, n=810) and those who did not (untested group, n=94, representing 10.4% of the entire study population) revealed that the untested group were older (P<0.01), had a lower left ventricular ejection fraction, a wider QRS complex and a higher New York Heart Association class and were more often implanted for primary prevention (P<0.001 for all). The main reason given for not performing ICD testing was poor haemodynamic condition (59/94). At 1 year, the cumulative survival rate was 95% in tested patients and 85% in untested patients (P<0.001), mainly because of heart failure deaths. There was one sudden cardiac death in the VF induction group and none in the untested group (P=1.000). In this study, more than 10% of ICD patients were implanted without VF induction. Untested patients appeared to be sicker than tested patients, with a more severe long-term outcome, but without any difference in mortality due to arrhythmic events. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

Operational Assessment of ICDS Scheme at Grass Root Level in a Rural Area of Eastern India: Time to Introspect

PubMed Central

Sahoo, Jyotiranjan; Mahajan, Preetam B; Bhatia, Vikas; Patra, Abhinash K; Hembram, Dilip Kumar

2016-01-01

Introduction Integrated Child Development Service (ICDS), a flagship program of Government of India (GoI) for early childhood development hasn’t delivered the desired results since its inception four decades ago. This could be due to infrastructural problems, lack of awareness and proper utilization by the local people, inadequate program monitoring and corruption in food supplies, etc. This study is an audit of 36 Anganwadi centres at Khordha district, Odisha, to evaluate the implementation of the ICDS. Aim To assess operational aspects of ICDS program in a rural area of Odisha, in Eastern India. Materials and Methods A total of 36 out of 50 Anganwadi Centres (AWCs) were included in the study. We interviewed the Anganwadi Workers (AWW) and carried out observations on the AWCs using a checklist. We gathered information under three domains manpower resource, material resource and functional aspects of the AWC. Results Most of the AWCs were adequately staffed. Most of the AWWs were well educated. However, more than 85% of the AWCs did not have designated building for daily functioning which resulted in issues related to implementation of program. Water, toilet and electricity facilities were almost non-existent. Indoor air pollution posed a serious threat to the health of the children. Lack of play materials; lack of health assessment tools for promoting, monitoring physical and mental development; and multiple de-motivating factors within the work environment, eventually translated into lack of faith among the beneficiaries in the rural community. Conclusion Inadequate infrastructure and logistic supply were the most prominent issues found, which resulted in poor implementation of ICDS program. Strengthening of grass root level facilities based on need assessment, effective monitoring and supervision will definitely help in revamping the ICDS program in rural areas. PMID:28208890

Complications after cardiac implantable electronic device implantations: an analysis of a complete, nationwide cohort in Denmark

PubMed Central

Kirkfeldt, Rikke Esberg; Johansen, Jens Brock; Nohr, Ellen Aagaard; Jørgensen, Ole Dan; Nielsen, Jens Cosedis

2014-01-01

Aims Complications after cardiac implantable electronic device (CIED) treatment, including permanent pacemakers (PMs), cardiac resynchronization therapy devices with defibrillators (CRT-Ds) or without (CRT-Ps), and implantable cardioverter defibrillators (ICDs), are associated with increased patient morbidity, healthcare costs, and possibly increased mortality. Methods and results Population-based cohort study in all Danish patients who underwent a CIED procedure from May 2010 to April 2011. Data on complications were gathered on review of all patient charts while baseline data were obtained from the Danish Pacemaker and ICD Register. Adjusted risk ratios (aRRs) with 95% confidence intervals were estimated using binary regression. The study population consisted of 5918 consecutive patients. A total of 562 patients (9.5%) experienced at least one complication. The risk of any complication was higher if the patient was a female (aRR 1.3; 1.1–1.6), underweight (aRR 1.5; 1.1–2.3), implanted in a centre with an annual volume <750 procedures (0–249 procedures: aRR 1.6; 1.1–2.2, 250–499: aRR 2.0; 1.6–2.7, 500–749: aRR 1.5; 1.2–1.8), received a dual-chamber ICD (aRR 2.0; 1.4–2.7) or CRT-D (aRR 2.6; 1.9–3.4), underwent system upgrade or lead revision (aRR 1.3; 1.0–1.7), had an operator with an annual volume <50 procedures (aRR 1.9; 1.4–2.6), or underwent an emergency, out-of-hours procedure (aRR 1.5; 1.0–2.3). Conclusion CIED complications are more frequent than generally acknowledged. Both patient- and procedure-related predictors may identify patients with a particularly high risk of complications. This information should be taken into account both in individual patient treatment and in the planning of future organization of CIED treatment. PMID:24347317

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.

Results from the Veterans Health Administration ICD-10-CM/PCS Coding Pilot Study.

PubMed

Weems, Shelley; Heller, Pamela; Fenton, Susan H

2015-01-01

The Veterans Health Administration (VHA) of the US Department of Veterans Affairs has been preparing for the October 1, 2015, conversion to the International Classification of Diseases, Tenth Revision, Clinical Modification and Procedural Coding System (ICD-10-CM/PCS) for more than four years. The VHA's Office of Informatics and Analytics ICD-10 Program Management Office established an ICD-10 Learning Lab to explore expected operational challenges. This study was conducted to determine the effects of the classification system conversion on coding productivity. ICD codes are integral to VHA business processes and are used for purposes such as clinical studies, performance measurement, workload capture, cost determination, Veterans Equitable Resource Allocation (VERA) determination, morbidity and mortality classification, indexing of hospital records by disease and operations, data storage and retrieval, research purposes, and reimbursement. The data collection for this study occurred in multiple VHA sites across several months using standardized methods. It is commonly accepted that coding productivity will decrease with the implementation of ICD-10-CM/PCS. The findings of this study suggest that the decrease will be more significant for inpatient coding productivity (64.5 percent productivity decrease) than for ambulatory care coding productivity (6.7 percent productivity decrease). This study reveals the following important points regarding ICD-10-CM/PCS coding productivity: 1. Ambulatory care ICD-10-CM coding productivity is not expected to decrease as significantly as inpatient ICD-10-CM/PCS coding productivity. 2. Coder training and type of record (inpatient versus outpatient) affect coding productivity. 3. Inpatient coding productivity is decreased when a procedure requiring ICD-10-PCS coding is present. It is highly recommended that organizations perform their own analyses to determine the effects of ICD-10-CM/PCS implementation on coding productivity.

Results from the Veterans Health Administration ICD-10-CM/PCS Coding Pilot Study

PubMed Central

Weems, Shelley; Heller, Pamela; Fenton, Susan H.

2015-01-01

The Veterans Health Administration (VHA) of the US Department of Veterans Affairs has been preparing for the October 1, 2015, conversion to the International Classification of Diseases, Tenth Revision, Clinical Modification and Procedural Coding System (ICD-10-CM/PCS) for more than four years. The VHA's Office of Informatics and Analytics ICD-10 Program Management Office established an ICD-10 Learning Lab to explore expected operational challenges. This study was conducted to determine the effects of the classification system conversion on coding productivity. ICD codes are integral to VHA business processes and are used for purposes such as clinical studies, performance measurement, workload capture, cost determination, Veterans Equitable Resource Allocation (VERA) determination, morbidity and mortality classification, indexing of hospital records by disease and operations, data storage and retrieval, research purposes, and reimbursement. The data collection for this study occurred in multiple VHA sites across several months using standardized methods. It is commonly accepted that coding productivity will decrease with the implementation of ICD-10-CM/PCS. The findings of this study suggest that the decrease will be more significant for inpatient coding productivity (64.5 percent productivity decrease) than for ambulatory care coding productivity (6.7 percent productivity decrease). This study reveals the following important points regarding ICD-10-CM/PCS coding productivity: Ambulatory care ICD-10-CM coding productivity is not expected to decrease as significantly as inpatient ICD-10-CM/PCS coding productivity.Coder training and type of record (inpatient versus outpatient) affect coding productivity.Inpatient coding productivity is decreased when a procedure requiring ICD-10-PCS coding is present. It is highly recommended that organizations perform their own analyses to determine the effects of ICD-10-CM/PCS implementation on coding productivity. PMID:26396553

Time dependence of risks and benefits in pediatric primary prevention implantable cardioverter-defibrillator therapy.

PubMed

DeWitt, Elizabeth S; Triedman, John K; Cecchin, Frank; Mah, Doug Y; Abrams, Dominic J; Walsh, Edward P; Gauvreau, Kimberlee; Alexander, Mark E

2014-12-01

Implantable cardioverter defibrillators (ICDs) used to prevent sudden cardiac arrest in children not only provide appropriate therapy in 25% of patients but also result in a significant incidence of inappropriate shocks and other device complications. ICDs placed for secondary prevention have higher rates of appropriate therapy than those placed for primary prevention. Pediatric patients with primary prevention ICDs were studied to determine time-dependent incidence of appropriate use and adverse events. A total of 140 patients aged <21 years (median age, 15 years) at first ICD implantation at Boston Children's Hospital (2000-2009) in whom devices were placed for primary prevention were retrospectively identified. Demographics and times to first appropriate shock; adverse events (including inappropriate shock, lead failure, reintervention, and complication); generator replacement and follow-up were noted. During mean follow-up of 4 years, appropriate shock occurred in 19% patients and first adverse event (excluding death/transplant) occurred in 36%. Risk of death or transplant was ≈1% per year and was not related to receiving appropriate therapy. Conditional survival analysis showed rates of appropriate therapy and adverse events decrease soon after implantation, but adverse events are more frequent than appropriate therapy throughout follow-up. Primary prevention ICDs were associated with appropriate therapy in 19% and adverse event in 36% in this cohort. The incidence of both first appropriate therapy and device-related adverse events decreased during longer periods of follow-up after implantation. This suggests that indications for continued device therapy in pediatric primary prevention ICD patients might be reconsidered after a period of nonuse. © 2014 American Heart Association, Inc.

Dutch outcome in implantable cardioverter-defibrillator therapy (DO-IT): registry design and baseline characteristics of a prospective observational cohort study to predict appropriate indication for implantable cardioverter-defibrillator.

PubMed

van Barreveld, M; Dijkgraaf, M G W; Hulleman, M; Boersma, L V A; Delnoy, P P H M; Meine, M; Tuinenburg, A E; Theuns, D A M J; van der Voort, P H; Kimman, G P; Buskens, E; Tijssen, J P G; Bruinsma, N; Verstraelen, T E; Zwinderman, A H; van Dessel, P H F M; Wilde, A A M

2017-10-01

Implantable cardioverter-defibrillators (ICDs) are widely used for the prevention of sudden cardiac death. At present, both clinical benefit and cost-effectiveness of ICD therapy in primary prevention patients are topics of discussion, as only a minority of these patients will eventually receive appropriate ICD therapy. The DO-IT Registry is a nationwide prospective cohort with a target enrolment of 1,500 primary prevention ICD patients with reduced left ventricular function in a setting of structural heart disease. The primary outcome measures are death and appropriate ICD therapy for ventricular tachyarrhythmias. Secondary outcome measures are inappropriate ICD therapy, death of any cause, hospitalisation for ICD related complications and for cardiovascular reasons. As of December 2016, data on demographic, clinical, and ICD characteristics of 1,468 patients have been collected. Follow-up will continue up to 24 months after inclusion of the last patient. During follow-up, clinical and ICD data are collected based on the normal follow-up of these patients, assuming ICD interrogations take place every six months and clinical follow-up is once a year. At baseline, the mean age was 66 (standard deviation [SD] 10) years and 27% were women. The DO-IT Registry represents a real-world nationwide cohort of patients receiving ICDs for primary prevention of sudden cardiac death with reduced left ventricular function in a setting of structural heart disease. The registry investigates the efficacy of the current practice and aims to develop prediction rules to identify subgroups who will not (sufficiently) benefit from ICD implantation and to provide results regarding costs and budget impact of targeted supply of primary preventions ICDs.

Prospective evaluation of defibrillation threshold and postshock rhythm in young ICD recipients.

PubMed

Radbill, Andrew E; Triedman, John K; Berul, Charles I; Walsh, Edward P; Alexander, Mark E; Webster, Gregory; Cecchin, Frank

2012-12-01

Adaptation of implantable cardioverter defibrillator (ICD) systems to the needs of pediatric and congenital heart patients is problematic due to constraints of vascular and thoracic anatomy. An improved understanding of the defibrillation energy and postshock pacing requirements in such patients may help direct more tailored ICD therapy. We describe the first prospective evaluation of defibrillation threshold (DFT) and postshock rhythm in this population. We prospectively studied patients ≤ 60 kg at time of ICD intervention. DFTs were obtained using a binary search protocol with three VF inductions. Postshock pacing was programmed using a stepwise protocol, lowering the rate prior to each VF induction. Twenty patients were enrolled: 11 had channelopathy, five congenital heart disease, and four cardiomyopathy. The median age was 16 years, median weight 48 kg. Twelve patients had a transvenous high-voltage coil; eight had pericardial +/- subcutaneous coil(s). Median DFT was 7 J (range 3-31 J); 19/20 patients had DFT ≤ 15 J and all patients <25 kg had DFT ≤ 9 J (n = 6). There was no difference in DFT between patients with transvenous versus pericardial +/- subcutaneous coils (median 7 J vs 6 J, P = 0.59). No patient with normal atrioventricular conduction prior to defibrillation required postshock pacing (n = 16). There were no adverse events. These data suggest that many pediatric ICD patients have low DFTs and adequate postshock escape rhythm. This may help determine appropriate parameters for future design of pediatric-specific ICDs. ©2012, The Authors. Journal compilation ©2012 Wiley Periodicals, Inc.

Athletes with Implantable Cardioverter Defibrillators

PubMed Central

Ponamgi, Shiva P.; DeSimone, Christopher V.; Ackerman, Michael J.

2015-01-01

Summary Athletes with an implantable cardioverter defibrillator (ICD) represent a diverse group of individuals who may be at an increased risk of sudden cardiac death (SCD) when engaging in vigorous physical activity. Therefore, they are excluded by the current guidelines from participating in most competitive sports except those classified as low intensity, such as bowling and golf. The lack of substantial data on the natural history of the cardiac diseases affecting these athletes, as well as the unknown efficacy of implanted ICDs in terminating life-threatening arrhythmias occurring during intense exercise, have resulted in the restrictive nature of these now decade old guidelines. Recently, there is emerging data, derived from a few retrospective studies and a large prospective registry that demonstrates the relative safety of high-risk athletes participating in competitive sports and challenges the prohibitive nature of these guidelines. Nevertheless, the safe participation of all athletes with an ICD in competitive sports continues to be contemplated. The increased number of inappropriate shocks, damage to the ICD/pacemaker system, and the questionable efficacy of the delivered shock in the setting of vigorous physical activity are some of the main challenges faced by these athletes who choose to continue participation in competitive sports. The fear of SCD and ICD shocks faced by these athletes is also associated with a negative psychological burden and affects their quality of life, as does restricting them from all competitive sports. Therefore, shared decision making is necessary between the clinician and athlete after carefully analyzing the risks and benefits associated with competitive sports participation. PMID:26100423

Feedback to providers improves evidence-based implantable cardioverter-defibrillator programming and reduces shocks.

PubMed

Silver, Marc T; Sterns, Laurence D; Piccini, Jonathan P; Joung, Boyoung; Ching, Chi-Keong; Pickett, Robert A; Rabinovich, Rafael; Liu, Shufeng; Peterson, Brett J; Lexcen, Daniel R

2015-03-01

Implantable cardioverter-defibrillator (ICD) shocks are associated with increased anxiety, health care utilization, and potentially mortality. The purpose of the Shock-Less Study was to determine if providing feedback reports to physicians on their adherence to evidence-based shock reduction programming could improve their programming behavior and reduce shocks. Shock-Less enrolled primary prevention (PP) and secondary prevention (SP) ICD patients between 2009 and 2012 at 118 study centers worldwide and followed patients longitudinally after their ICD implant. Center-specific therapy programming reports (TPRs) were delivered to each center 9 to 12 months after their first enrollment. The reports detailed adherence to evidence-based programming targets: number of intervals to detect ventricular fibrillation (VF NID), longest treatment interval (LTI), supraventricular tachycardia (SVT) discriminators (Wavelet, PR Logic), SVT limit, Lead Integrity Alert (LIA), and antitachycardia pacing (ATP). Clinicians programmed ICDs at their discretion. The primary outcome measure was the change in utilization of evidence-based shock reduction programming before (phase I, n = 2694 patients) and after initiation of the TPR (phase II, n = 1438 patients). Patients implanted after feedback reports (phase II) were up to 20% more likely to have their ICDs programmed in line with evidence-based shock reduction programming (eg, VF NID in PP patients 30/40 in 33.5% vs 18.6%, P < .0001). Patients implanted in phase II had a lower risk of all-cause shock (adjusted hazard ratio 0.72, 95% confidence interval 0.58-0.90, P = .003). Providing programming feedback reports improves adherence to evidence-based shock reduction programming and is associated with lower risk of ICD shocks. Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Multi-Center, Community-Based Cardiac Implantable Electronic Devices Registry: Population, Device Utilization, and Outcomes.

PubMed

Gupta, Nigel; Kiley, Mary Lou; Anthony, Faith; Young, Charlie; Brar, Somjot; Kwaku, Kevin

2016-03-09

The purpose of this study is to describe key elements, clinical outcomes, and potential uses of the Kaiser Permanente-Cardiac Device Registry. This is a cohort study of implantable cardioverter defibrillators (ICD), pacemakers (PM), and cardiac resynchronization therapy (CRT) devices implanted between January 1, 2007 and December 31, 2013 by ≈400 physicians in 6 US geographical regions. Registry data variables, including patient characteristics, comorbidities, indication for procedures, complications, and revisions, were captured using the healthcare system's electronic medical record. Outcomes were identified using electronic screening algorithms and adjudicated via chart review. There were 11 924 ICDs, 33 519 PMs, 4472 CRTs, and 66 067 leads registered. A higher proportion of devices were implanted in males: 75.1% (ICD), 55.0% (PM), and 66.7% (CRT), with mean patient age 63.2 years (ICD), 75.2 (PM), and 67.2 (CRT). The 30-day postoperative incidence of tamponade, hematoma, and pneumothorax were ≤0.3% (ICD), ≤0.6% (PM), and ≤0.4% (CRT). Device failures requiring revision occurred at a rate of 2.17% for ICDs, 0.85% for PMs, and 4.93% for CRTs, per 100 patient observation years. Superficial infection rates were <0.03% for all devices; deep infection rates were 0.6% (ICD), 0.5% (PM), and 1.0% (CRT). Results were used to monitor vendor-specific variations and were systematically shared with individual regions to address potential variations in outcomes, utilization, and to assist with the management of device recalls. The Kaiser Permanente-Cardiac Device Registry is a robust tool to monitor postprocedural patient outcomes and postmarket surveillance of implants and potentially change practice patterns. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Influence of radiotherapy on the latest generation of implantable cardioverter-defibrillators

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

Hurkmans, Coen W.; Scheepers, Egon; Springorum, Bob G.F.

2005-09-01

Purpose: Radiotherapy can influence the functioning of pacemakers and implantable cardioverter-defibrillators (ICDs). ICDs offer the same functionality as pacemakers, but are also able to deliver a high-voltage shock to the heart if needed. Guidelines for radiotherapy treatment of patients with an implanted rhythm device have been published in 1994 by The American Association of Physicists in Medicine, and are based only on experience with pacemakers. Data on the influence of radiotherapy on ICDs are limited. The objective of our study is to determine the influence of radiotherapy on the latest generation of ICDs. Methods and Materials: Eleven modern ICDs havemore » been irradiated in our department. The irradiation was performed with a 6-MV photon beam. The given dose was fractionated up to a cumulative dose of 120 Gy. Two to 5 days passed between consecutive irradiations. Frequency, output, sensing, telemetry, and shock energy were monitored. Results: Sensing interference by ionizing radiation on all ICDs has been demonstrated. For four ICDs, this would have caused the inappropriate delivery of a shock because of interference. At the end of the irradiation sessions, all devices had reached their point of failure. Complete loss of function was observed for four ICDs at dose levels between 0.5 Gy and 1.5 Gy. Conclusions: The effect of radiation therapy on the newest generation of ICDs varies widely. If tachycardia monitoring and therapy are functional (programmed on) during irradiation, the ICD might inappropriately give antitachycardia therapy, often resulting in a shock. Although most ICDs did not fail below 80 Gy, some devices had already failed at doses below 1.5 Gy. Guidelines are formulated for the treatment of patients with an ICD.« less

Age and Outcomes of Primary Prevention Implantable Cardioverter-Defibrillators in Patients With Nonischemic Systolic Heart Failure.

PubMed

Elming, Marie Bayer; Nielsen, Jens C; Haarbo, Jens; Videbæk, Lars; Korup, Eva; Signorovitch, James; Olesen, Line Lisbeth; Hildebrandt, Per; Steffensen, Flemming H; Bruun, Niels E; Eiskjær, Hans; Brandes, Axel; Thøgersen, Anna M; Gustafsson, Finn; Egstrup, Kenneth; Videbæk, Regitze; Hassager, Christian; Svendsen, Jesper Hastrup; Høfsten, Dan E; Torp-Pedersen, Christian; Pehrson, Steen; Køber, Lars; Thune, Jens Jakob

2017-11-07

The DANISH study (Danish Study to Assess the Efficacy of ICDs [Implantable Cardioverter Defibrillators] in Patients With Non-Ischemic Systolic Heart Failure on Mortality) did not demonstrate an overall effect on all-cause mortality with ICD implantation. However, the prespecified subgroup analysis suggested a possible age-dependent association between ICD implantation and mortality with survival benefit seen only in the youngest patients. The nature of this relationship between age and outcome of a primary prevention ICD in patients with nonischemic systolic heart failure warrants further investigation. All 1116 patients from the DANISH study were included in this prespecified subgroup analysis. We assessed the relationship between ICD implantation and mortality by age, and an optimal age cutoff was estimated nonparametrically with selection impact curves. Modes of death were divided into sudden cardiac death and nonsudden death and compared between patients younger and older than this age cutoff with the use of χ 2 analysis. Median age of the study population was 63 years (range, 21-84 years). There was a linearly decreasing relationship between ICD and mortality with age (hazard ratio [HR], 1.03; 95% confidence interval [CI], 1.003-1.06; P =0.03). An optimal age cutoff for ICD implantation was present at ≤70 years. There was an association between reduced all-cause mortality and ICD in patients ≤70 years of age (HR, 0.70; 95% CI, 0.51-0.96; P =0.03) but not in patients >70 years of age (HR, 1.05; 95% CI, 0.68-1.62; P =0.84). For patients ≤70 years old, the sudden cardiac death rate was 1.8 (95% CI, 1.3-2.5) and nonsudden death rate was 2.7 (95% CI, 2.1-3.5) events per 100 patient-years, whereas for patients >70 years old, the sudden cardiac death rate was 1.6 (95% CI, 0.8-3.2) and nonsudden death rate was 5.4 (95% CI, 3.7-7.8) events per 100 patient-years. This difference in modes of death between the 2 age groups was statistically significant ( P =0

Mechanical dispersion and global longitudinal strain by speckle tracking echocardiography: Predictors of appropriate implantable cardioverter defibrillator therapy in hypertrophic cardiomyopathy.

PubMed

Candan, Ozkan; Gecmen, Cetin; Bayam, Emrah; Guner, Ahmet; Celik, Mehmet; Doğan, Cem

2017-06-01

In this study, we investigated whether mechanical dispersion which reflects electrical abnormality and other echocardiographic and clinic parameters predict appropriate ICD shock in patients undergone ICD implantation for hypertrophic cardiomyopathy. Sixty-three patients who received ICD implantation for primary or secondary prevention were included in the study. Patients' clinical, electrocardiographic, 2D classic, and speckle tracking echocardiographic data were collected. Mechanical dispersion was defined as the standard deviation of time to peak negative strain in 18 left ventricular segments. Appropriate ICD therapy was defined as cardioversion or defibrillation due to ventricular tachycardia or fibrillation. Patients were divided into two groups as occurrence or the absence of appropriate ICD therapy. A total of 17 (26.9%) patients were observed to have an appropriate ICD therapy during follow-up periods. In patients who performed appropriate ICD therapy, a larger left atrial volume index, higher sudden cardiac death (SCD)-Risk Score, longer mechanical dispersion, and decreased global longitudinal peak strain (GLPS) were observed. In multivariate logistic regression analysis, including (GLPS, mechanical dispersion, LAVi, and SCD-Risk Score) was used to determine independent predictors of occurrence of appropriate ICD therapy during the follow-up. Mechanical dispersion, GLPS, and SCD-Risk Score were found to be independent predictors of occurrence of appropriate ICD therapy. Mechanical dispersion, GLPS, and SCD-Risk Score were found to be predictive for appropriate ICD therapy in patients receiving ICD implantation. Readily measurable mechanical dispersion and GLPS could be helpful to distinguish patients at high risk who could optimally benefit from ICD therapy. © 2017, Wiley Periodicals, Inc.

Influence of primary and secondary prevention indications on anxiety about the implantable cardioverter-defibrillator.

PubMed

Rahmawati, Anita; Chishaki, Akiko; Ohkusa, Tomoko; Sawatari, Hiroyuki; Tsuchihashi-Makaya, Miyuki; Ohtsuka, Yuko; Nakai, Mori; Miyazono, Mami; Hashiguchi, Nobuko; Sakurada, Harumizu; Takemoto, Masao; Mukai, Yasushi; Inoue, Shujirou; Sunagawa, Kenji; Chishaki, Hiroaki

2016-04-01

Implantable cardioverter-defibrillators (ICDs) have been established for primary and secondary prevention of fatal arrhythmias. However, little is known about the influence of ICD indications on quality of life (QOL) and psychological disturbances. This study aimed to examine whether there were differences in QOL and psychological distress in patients that have an ICD for primary or secondary prevention of fatal arrhythmias. A multicenter survey of 179 consecutive outpatients (29.1% primary prevention) with ICD implantations completed the Short Form-8 (SF-8), Beck Depression Inventory (BDI), Impact of Event Scale-Revised (IES-R), State-Trait Anxiety Inventory (STAI), and Worries about ICD (WAICD). Patients with an ICD for primary prevention had a higher trait anxiety score and worries about ICD score than patients with an ICD for secondary prevention (41.7±12.4 vs. 34.7±12.3, p=0.001 and 39.6±18.0 vs. 30.0±18.9, p=0.002, respectively), even after adjusting for demographic and clinical characteristics. In multivariable analysis of variance, primary prevention ICD recipients reported a poorer QOL on the vitality subscale of the SF-8. In our study population, which mostly consisted of New York Heart Association (NYHA) class I and II subjects, primary prevention ICD recipients were more prone to experience worries about their ICD, anxiety, and a poorer QOL compared to secondary prevention ICD recipients. In clinical practice, primary prevention ICD patients should be closely monitored. If warranted, they should be offered psychological intervention, as anxiety and low QOL were predictors of mortality.

Simulation of ICD-9 to ICD-10-CM Transition for Family Medicine: Simple or Convoluted?

PubMed

Grief, Samuel N; Patel, Jesal; Kochendorfer, Karl M; Green, Lee A; Lussier, Yves A; Li, Jianrong; Burton, Michael; Boyd, Andrew D

2016-01-01

The objective of this study was to examine the impact of the transition from International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM), to Interactional Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM), on family medicine and to identify areas where additional training might be required. Family medicine ICD-9-CM codes were obtained from an Illinois Medicaid data set (113,000 patient visits and $5.5 million in claims). Using the science of networks, we evaluated each ICD-9-CM code used by family medicine physicians to determine whether the transition was simple or convoluted. A simple transition is defined as 1 ICD-9-CM code mapping to 1 ICD-10-CM code, or 1 ICD-9-CM code mapping to multiple ICD-10-CM codes. A convoluted transition is where the transitions between coding systems is nonreciprocal and complex, with multiple codes for which definitions become intertwined. Three family medicine physicians evaluated the most frequently encountered complex mappings for clinical accuracy. Of the 1635 diagnosis codes used by family medicine physicians, 70% of the codes were categorized as simple, 27% of codes were convoluted, and 3% had no mapping. For the visits, 75%, 24%, and 1% corresponded with simple, convoluted, and no mapping, respectively. Payment for submitted claims was similarly aligned. Of the frequently encountered convoluted codes, 3 diagnosis codes were clinically incorrect, but they represent only <0.1% of the overall diagnosis codes. The transition to ICD-10-CM is simple for 70% or more of diagnosis codes, visits, and reimbursement for a family medicine physician. However, some frequently used codes for disease management are convoluted and incorrect, and for which additional resources need to be invested to ensure a successful transition to ICD-10-CM. © Copyright 2016 by the American Board of Family Medicine.

Simulation of ICD-9 to ICD-10-CM transition for family medicine: simple or convoluted?

PubMed Central

Grief, Samuel N.; Patel, Jesal; Lussier, Yves A.; Li, Jianrong; Burton, Michael; Boyd, Andrew D.

2017-01-01

Objectives The objective of this study was to examine the impact of the transition from International Classification of Disease Version Nine Clinical Modification (ICD-9-CM) to Interactional Classification of Disease Version Ten Clinical Modification (ICD-10-CM) on family medicine and identify areas where additional training might be required. Methods Family medicine ICD-9-CM codes were obtained from an Illinois Medicaid data set (113,000 patient visits and $5.5 million dollars in claims). Using the science of networks we evaluated each ICD-9-CM code used by family medicine physicians to determine if the transition was simple or convoluted.1 A simple translation is defined as one ICD-9-CM code mapping to one ICD-10-CM code or one ICD-9-CM code mapping to multiple ICD-10-CM codes. A convoluted transition is where the transitions between coding systems is non-reciprocal and complex with multiple codes where definitions become intertwined. Three family medicine physicians evaluated the most frequently encountered complex mappings for clinical accuracy. Results Of the 1635 diagnosis codes used by the family medicine physicians, 70% of the codes were categorized as simple, 27% of the diagnosis codes were convoluted and 3% were found to have no mapping. For the visits, 75%, 24%, and 1% corresponded with simple, convoluted, and no mapping, respectively. Payment for submitted claims were similarly aligned. Of the frequently encountered convoluted codes, 3 diagnosis codes were clinically incorrect, but they represent only < 0.1% of the overall diagnosis codes. Conclusions The transition to ICD-10-CM is simple for 70% or more of diagnosis codes, visits, and reimbursement for a family medicine physician. However, some frequently used codes for disease management are convoluted and incorrect, where additional resources need to be invested to ensure a successful transition to ICD-10-CM. PMID:26769875

In vitro assessment of the immunity of implantable cardioverter-defibrillators to magnetic fields of 50/60 Hz.

PubMed

Katrib, J; Nadi, M; Kourtiche, D; Magne, I; Schmitt, P; Souques, M; Roth, P

2013-10-01

Public concern for the compatibility of electromagnetic (EM) sources with active implantable medical devices (AIMD) has prompted the development of new systems that can perform accurate exposure studies. EM field interference with active cardiac implants (e.g. implantable cardioverter-defibrillators (ICDs)) can be critical. This paper describes a magnetic field (MF) exposure system and the method developed for testing the immunity of ICD to continuous-wave MFs. The MFs were created by Helmholtz coils, housed in a Faraday cage. The coils were able to produce highly uniform MFs up to 4000 µT at 50 Hz and 3900 µT at 60 Hz, within the test space. Four ICDs were tested. No dysfunctions were found in the generated MFs. These results confirm that the tested ICDs were immune to low frequency MFs.

Implantable Cardiac Defibrillator Lead Failure and Management.

PubMed

Swerdlow, Charles D; Kalahasty, Gautham; Ellenbogen, Kenneth A

2016-03-22

The implantable-cardioverter defibrillator (ICD) lead is the most vulnerable component of the ICD system. Despite advanced engineering design, sophisticated manufacturing techniques, and extensive bench, pre-clinical, and clinical testing, lead failure (LF) remains the Achilles' heel of the ICD system. ICD LF has a broad range of adverse outcomes, ranging from intermittent inappropriate pacing to proarrhythmia leading to patient mortality. ICD LF is often considered in the context of design or construction defects, but is more appropriately considered in the context of the finite service life of a mechanical component placed in chemically stressful environment and subjected to continuous mechanical stresses. This clinical review summarizes LF mechanisms, assessment, and differential diagnosis of LF, including lead diagnostics, recent prominent lead recalls, and management of LF and functioning, but recalled leads. Despite recent advances in lead technology, physicians will likely continue to need to understand how to manage patients with transvenous ICD leads. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Complications leading to surgical revision in implantable cardioverter defibrillator patients: comparison of patients with single-chamber, dual-chamber, and biventricular devices.

PubMed

Duray, Gabor Z; Schmitt, Joern; Cicek-Hartvig, Sule; Hohnloser, Stefan H; Israel, Carsten W

2009-03-01

Implantable cardioverter defibrillator (ICD) technology has become more complex, particularly with respect to biventricular resynchronization devices. The incidence of hardware-related complications in single (SC)-, dual (DC)-, and triple (BiV)-chamber devices requiring surgical revision has not been investigated systematically. We analysed data from consecutive ICD recipients implanted between January 2000 and December 2007 with respect to the need of surgical re-intervention for device- or lead-related complications. Generator exchanges due to normal battery depletion were not considered. From 816 patients (81% male, 69% ischaemic cardiomyopathy, 48% secondary prevention ICDs) followed for 31 +/- 24 months (2118 cumulative patient-years), 98 patients underwent 110 revisions (5.2% per patient-year). Complications included lead-related revision procedures in 81 cases and generator-related problems in 29 cases. The annual incidence of surgical revision due to complications was 11.8% in BiV compared with 4.9% in SC and 4.1% in DC patients (P = 0.002). This higher revision rate was mainly caused by lead-related complications. Implantation of a BiV system was an independent risk factor of the need for surgical revision (relative risk 2.37, 95% confidence interval 1.38-4.04). Even with long-lasting operator experience, complications requiring surgical revision remain a clinically important problem of ICD therapy. The incidence of complications is significantly higher in BiV resynchronization devices than in SC and DC systems.

Scar extent as a predictive factor of ventricular tachycardia cycle length after myocardial infarction: implications for implantable cardioverter-defibrillator programming optimization.

PubMed

Alexandre, Joachim; Saloux, Eric; Lebon, Alain; Dugué, Audrey Emmanuelle; Lemaitre, Adrien; Roule, Vincent; Labombarda, Fabien; Champ-Rigot, Laure; Gomes, Sophie; Pellissier, Arnaud; Scanu, Patrice; Milliez, Paul

2014-02-01

After an old myocardial infarction (MI), patients are at risk for reentrant ventricular tachycardia (VT) due to scar tissue that can be accurately identified by late gadolinium enhancement cardiac magnetic resonance (LGE-CMR). Although the ability of LGE-CMR to predict sustained VT in implantable cardioverter-defibrillator (ICD) recipients has been well established, its use to predict monomorphic VT (sustained or not) cycle length (CL) and so, optimize ICD programming has never been investigated. We included retrospectively 49 consecutive patients with an old MI who had undergone LGE-CMR before ICD implantation over a 4-year period (2006-09). Patients with amiodarone used were excluded. Scar extent was assessed by measuring scar mass, percent scar, and transmural scar extent. The endpoint was the occurrence of monomorphic VT, requiring an ICD therapy or not. The endpoint occurred in 26 patients. The median follow-up duration was 31 months. Scar extent parameters were significantly correlated with the study endpoint. With univariate regression analysis, the scar mass had the highest correlation with the VT CL (R = 0.671, P = 0.0002). Receiver-operating characteristic curve showed that scar mass can predict VT CL (area under the curve = 0.977, P < 0.0001). For a cut-off value of scar mass at 17.6 g, there is 100% specificity and 94.4% sensitivity. In this observational and retrospective study, scar mass studied by LGE-CMR was specific and sensitive to predict VT CL and so could be a promising option to improve ICD post-implantation programming and decrease appropriate and inappropriate shocks. These conclusions must now be confirmed in a large and prospective study.

Increasing sex differences in the use of cardiac resynchronization therapy with or without implantable cardioverter-defibrillator

PubMed Central

Chatterjee, Neal A.; Borgquist, Rasmus; Chang, Yuchiao; Lewey, Jennifer; Jackson, Vicki A.; Singh, Jagmeet P.; Metlay, Joshua P.; Lindvall, Charlotta

2017-01-01

Aims Previous studies have identified sex disparities in the use of cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillators (ICD), although the basis of underutilization in women remains poorly understood. The aim of this study was to assess sex differences in patterns of CRT use with our without ICD. Methods and results In this cross-sectional study using the National Inpatient Sample database we identified 311 009 patients undergoing CRT implantation in the United States between 2006 and 2012. Demographic and clinical characteristics were compared between men and women undergoing CRT implantation, with special attention to clinical predictors of left ventricular reverse remodelling (CRT response, score range: 0–4) and reduced ICD efficacy (score range: 0–7). When compared to men, women undergoing CRT implantation were significantly more likely to have ≥ 3 predictors of CRT response (47.3 vs. 33.2%, P < 0.001) and less likely to have ≥3 predictors of reduced ICD efficacy (27.0 vs. 37.3%, P < 0.001). Despite this, men were significantly more likely to undergo CRT with ICD (CRT-D) as the type of CRT (88.6 vs. 80.1% of all CRT implants). Compared to those with the greatest likelihood of CRT response (score ≥ 3), those with the least likelihood of CRT response had a significant decreased odds of CRT-D implant (adj odds ratio 0.27 [0.24–0.31], P < 0.001), with a greater decreased odds in women compared to men (P, for sex interaction <0.001). The difference in the % of CRT-D implant in men vs. women increased over the study period (P, sex Δ time trend = 0.012). Conclusion In this large, contemporary cohort, sex differences in CRT-D implantation were inversely related to predicted CRT efficacy and have increased over time. Future efforts to narrow the gap in CRT-D implantation in men and women may help better align device selection with those most likely to benefit. PMID:28065904

Ventricular tachyarrhythmias and mortality in patients with an implantable cardioverter defibrillator: impact of depression in the MIDAS cohort.

PubMed

Mastenbroek, Mirjam H; Versteeg, Henneke; Jordaens, Luc; Theuns, Dominic A M J; Pedersen, Susanne S

2014-01-01

We examined whether depression is independently associated with implantable cardioverter defibrillator (ICD) therapy for ventricular tachyarrhythmias and mortality. A cohort of 430 consecutive patients with a first-time ICD (79% men; mean [standard deviation] age = 57.8 [12.1] years) completed the Hospital Anxiety and Depression Scale 1 day before implantation. During follow-up, the ICD was interrogated at 3-month intervals. Cox proportional hazard regression analyses were used to examine the impact of depression on time to first appropriate ICD therapy and all-cause mortality during a median follow-up period of 3.8 years. Of all patients, 108 (25.1%) were depressed. Depression was not associated with time to first appropriate ICD therapy (unadjusted hazard ratio [HR] = 1.07, 95% confidence interval [CI] = 0.73-1.56). However, depression was associated with an increased risk for all-cause mortality (unadjusted HR = 2.18, 95% CI = 1.36-3.49). Depression remained independently associated with all-cause mortality (HR = 1.94, 95% CI = 1.06-3.54, p = .031), after adjusting for demographic and clinical characteristics. Patients who remained depressed during the first 3 months after implantation were at greatest risk for dying (HR = 2.88, 95% CI = 1.29-6.45, p = .010). The current study showed that depression at the time of implant is not associated with time to first appropriate ICD therapy but almost doubled the risk for all-cause mortality in patients with an ICD. Patients with persistent depression during the first 3 months after implantation face the greatest risk of dying. Current evidence indicates that multifactorial interventions are likely to be the most successful in terms of reducing distress. Whether this translates into enhanced survival has yet to be determined.

Utilization Rates of Implantable Cardioverter-Defibrillators for Primary Prevention of Sudden Cardiac Death: A 2012 Calculation for a Midwestern Health Referral Region

PubMed Central

Hoang, Allen; Shen, Changyu; Zheng, James; Taylor, Stanley; Groh, William J; Rosenman, Marc; Buxton, Alfred E.; Chen, Peng-Sheng

2014-01-01

Background Utilization rates (URs) for implantable cardioverter-defibrillators (ICDs) for primary prevention of sudden cardiac death (PPSCD) are lacking in the community. Objective To establish the ICD UR in central Indiana. Methods A query run on two hospitals in a health information exchange database in Indianapolis identified patients between 2011 and 2012 with left ventricular ejection fraction (EF) ≤0.35. ICD-eligibility and utilization were determined from chart review. Results We identified 1,863 patients with at least one low-EF study. Two cohorts were analyzed: 1,672 patients without, and 191 patients with, ICD-9-CM procedure code 37.94 for ICD placement. We manually reviewed a stratified (by hospital) random sample of 300 patients from the no-ICD procedure code cohort and found that 48 (16%) had no ICD but had class I indications for ICD. Eight of 300 (2.7%) actually had ICD implantation for PPSCD. Review of all 191 patients in the ICD procedure code cohort identified 70 with ICD implantation for PPSCD. The ICD UR (ratio between patients with ICD for PPSCD and all with indication) was 38% overall (95% CI 28–49%). URs were 48% for males (95% CI 34–61%), 21% for females (95% CI 16–26%, p=0.0002 vs males), 40% for whites (95% CI 27–53%), and 37% for blacks (95% CI 28–46%, p=0.66 vs whites). Conclusions The ICD UR is 38% among patients meeting Class I indications, suggesting further opportunities to improve guideline compliance. Furthermore, this study illustrates limitations in calculating ICD UR using large electronic repositories without hands-on chart review. PMID:24566233

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

PubMed

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

2012-09-01

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

Evaluation of acute cardiac and chest wall damage after shocks with a subcutaneous implantable cardioverter-defibrillator in swine

PubMed Central

KILLINGSWORTH, CHERYL R.; MELNICK, SHARON B.; LITOVSKY, SILVIO H.; IDEKER, RAYMOND E.; WALCOTT, GREGORY P.

2013-01-01

Background A subcutaneous implantable cardioverter defibrillator (S-ICD) could ease placement and reduce complications of transvenous ICDs, but requires more energy than transvenous ICDs. Therefore we assessed cardiac and chest wall damage caused by the maximum energy shocks delivered by both types of clinical devices. Methods During sinus rhythm, anesthetized pigs (38±6 kg) received an S-ICD (n = 4) and five 80-Joule (J) shocks, or a transvenous ICD (control, n = 4) and five 35-J shocks. An inactive S-ICD electrode was implanted into the same control pigs to study implant trauma. All animals survived 24-hours. Troponin I and creatine kinase muscle isoenzyme (CK-MM) were measured as indicators of myocardial and skeletal muscle injury. Histopathological injury of heart, lungs, and chest wall was assessed using semi-quantitative scoring. Results Troponin I was significantly elevated at 4- and 24-hours (22.6±16.3 and 3.1±1.3 ng/ml; baseline 0.07±0.09 ng/ml) in control pigs but not in S-ICD pigs (0.12±0.11 and 0.13±0.13 ng/ml; baseline 0.06±0.03 ng/ml). CK-MM was significantly elevated in S-ICD pigs after shocks (6544±1496 and 9705±6240 U/L; baseline 704±398 U/L) but not in controls. ECG changes occurred post-shock in controls but not in S-ICD pigs. The myocardium and lungs were histologically normal in both groups. Subcutaneous injury was greater in S-ICD compared to controls. Conclusion Although CK-MM suggested more skeletal muscle injury in S-ICD pigs, significant cardiac, lung, and chest wall histopathological changes were not detected in either group. Troponin I data indicate significantly less cardiac injury from 80-J S-ICD shocks than 35-J transvenous shocks. PMID:23713608

Implantable Defibrillators for Secondary Prevention of Sudden Cardiac Death in Cardiac Surgery Patients With Perioperative Ventricular Arrhythmias

PubMed Central

Nageh, Maged F.; Kim, John J.; Chen, Lie‐Hong; Yao, Janis F.

2014-01-01

Background Randomized studies of implantable cardioverter defibrillators (ICD) have excluded sudden cardiac death survivors who had revascularization before or after an arrhythmic event. To evaluate the role of ICD and the effects of clinical variables including degree of revascularization, we studied cardiac surgery patients who had an ICD implanted for sustained perioperative ventricular arrhythmias. Methods and Results The electronic database for Southern California Kaiser Foundation hospitals was searched for patients who had cardiac surgery between 1999 and 2005 and an ICD implanted within 3 months of surgery. One hundred sixty‐four patients were identified; 93/164 had an ICD for sustained pre‐ or postoperative ventricular tachycardia or fibrillation requiring resuscitation. Records were reviewed for the following: presenting arrhythmia, ejection fraction, and degree of revascularization. The primary end point was total mortality (TM) and/or appropriate ICD therapy (ICD‐T), and secondary end points are TM and ICD‐T. During the mean follow up of 49 months, the primary endpoint of TM+ICD‐T and individual end points of TM and ICD‐T were observed in 52 (56%), 35 (38%), and 28 (30%) patients, respectively, with 55% of TM, and 23% of ICD‐T occurring within 2 years of implant. In multivariate risk analysis, none of the following was associated with any of the end points: incomplete revascularization, presenting ventricular arrhythmia, and timing of arrhythmias. Conclusion Our data supports the recent guidelines for ICD in this cohort of patients, as the presence of irreversible substrate and triggers of ventricular arrhythmias, cannot be reliably excluded even with complete revascularization. Further studies are needed to understand this complex group of patients. PMID:25146702

Frozen shoulder syndrome associated with subpectoral defibrillator implantation.

PubMed

Burke, M C; Drinan, K; Kopp, D E; Kall, J G; Verdino, R J; Paydak, H; Wilber, D J

1999-10-01

Pectoral implantation of transvenous non-thoracotomy internal cardioverter defibrillators (ICD) has resulted in very few complications whether placed subpectorally or subcutaneously. We report the case of a 68 year old man with a subpectorally implanted MINI-plus (Cardiac Pacemakers, Incorporated, St. Paul, Mn.) transvenous ICD who developed nearly instantaneous severe ipsilateral shoulder pain and immobilization. The symptoms progressed despite aggressive physical therapy. We elected to remove the device from the pectoral site and place it in a traditional abdominal position due to the severity, duration and refractoriness of his symptoms. This procedure utilized the chronic Endotak DSP (Model 0125, Cardiac Pacemakers, Incorporated) transvenous lead, a compatible Endotak DSP lead extender (Model 6952, Cardiac Pacemakers, Incorporated) and the above described ICD. Immediate relief of symptoms was accomplished by relocation of the device to an abdominal site. This intervention should be reserved for patients with severely debilitating symptoms. Prospective comparison of subpectoral and subcutaneous surgical approaches with respect to patient comfort and acceptance and complications may be warranted.

Reduced long-term overall mortality in heart failure patients with prolonged QRS treated with CRT combined with ICD vs. heart failure patients with narrow QRS treated with ICD only.

PubMed

Palmisano, Pietro; Accogli, Michele; Pisanò, Ennio Carmine Luigi; Zaccaria, Maria; De Blasi, Sergio; Ponzetta, Maria Antonietta; Valsecchi, Sergio; Milanese, Giovanni; Lauretti, Maurelio; Magliari, Francesco

2016-09-01

It is not known whether heart failure (HF) patients with prolonged QRS who undergo cardiac resynchronization therapy combined with a defibrillator (CRT-D) have a prognostic advantage over HF patients with narrow QRS (therefore without indication for CRT) treated with an implantable cardioverter defibrillator (ICD) only. The aim of this study was to compare the long-term mortality of a group of HF patients with prolonged QRS receiving CRT-D with that of a similar group of patients with narrow QRS receiving ICD only. A total of 312 patients (mean age 66 ± 13 years; 84% male, mean left ventricular ejection fraction 25 ± 4%, mean New York Heart Association class 2.6 ± 0.5) were included in the analysis. Of these, 138 with a QRS complex duration ≥120 ms received a CRT-D. During follow-up, the time and cause of death were assessed. During a median follow-up of 46 months, CRT-D patients showed significantly lower overall mortality (P = 0.038). Compared with patients receiving ICD only, CRT-D patients showed lower HF mortality (P = 0.003). Coronary mortality, non-cardiac mortality, and sudden mortality were similar in both groups (all P > 0.05). A positive response to CRT was an independent predictor of reduced mortality on multivariate analysis (hazard ratio: 0.27; P = 0.047). In HF patients treated with ICD, the subgroup of patients with prolonged QRS who receive CRT-D displays better long-term survival than narrow QRS ICD recipients, owing to their reduced HF mortality. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

Influence of primary and secondary prevention indications on anxiety about the implantable cardioverter-defibrillator

PubMed Central

Rahmawati, Anita; Chishaki, Akiko; Ohkusa, Tomoko; Sawatari, Hiroyuki; Tsuchihashi-Makaya, Miyuki; Ohtsuka, Yuko; Nakai, Mori; Miyazono, Mami; Hashiguchi, Nobuko; Sakurada, Harumizu; Takemoto, Masao; Mukai, Yasushi; Inoue, Shujirou; Sunagawa, Kenji; Chishaki, Hiroaki

2015-01-01

Background Implantable cardioverter-defibrillators (ICDs) have been established for primary and secondary prevention of fatal arrhythmias. However, little is known about the influence of ICD indications on quality of life (QOL) and psychological disturbances. This study aimed to examine whether there were differences in QOL and psychological distress in patients that have an ICD for primary or secondary prevention of fatal arrhythmias. Methods A multicenter survey of 179 consecutive outpatients (29.1% primary prevention) with ICD implantations completed the Short Form-8 (SF-8), Beck Depression Inventory (BDI), Impact of Event Scale-Revised (IES-R), State-Trait Anxiety Inventory (STAI), and Worries about ICD (WAICD). Results Patients with an ICD for primary prevention had a higher trait anxiety score and worries about ICD score than patients with an ICD for secondary prevention (41.7±12.4 vs. 34.7±12.3, p=0.001 and 39.6±18.0 vs. 30.0±18.9, p=0.002, respectively), even after adjusting for demographic and clinical characteristics. In multivariable analysis of variance, primary prevention ICD recipients reported a poorer QOL on the vitality subscale of the SF-8. Conclusions In our study population, which mostly consisted of New York Heart Association (NYHA) class I and II subjects, primary prevention ICD recipients were more prone to experience worries about their ICD, anxiety, and a poorer QOL compared to secondary prevention ICD recipients. In clinical practice, primary prevention ICD patients should be closely monitored. If warranted, they should be offered psychological intervention, as anxiety and low QOL were predictors of mortality. PMID:27092190

Manual for the psychotherapeutic treatment of acute and post-traumatic stress disorders following multiple shocks from implantable cardioverter defibrillator (ICD)

PubMed Central

Jordan, Jochen; Titscher, Georg; Peregrinova, Ludmila; Kirsch, Holger

2013-01-01

Background: In view of the increasing number of implanted cardioverter defibrillators (ICD), the number of people suffering from so-called “multiple ICD shocks” is also increasing. The delivery of more than five shocks (appropriate or inappropriate) in 12 months or three or more shocks (so called multiple shocks) in a short time period (24 hours) leads to an increasing number of patients suffering from severe psychological distress (anxiety disorder, panic disorder, adjustment disorder, post-traumatic stress disorder). Untreated persons show chronic disease processes and a low rate of spontaneous remission and have an increased morbidity and mortality. Few papers have been published concerning the psychotherapeutic treatment for these patients. Objective: The aim of this study is to develop a psychotherapeutic treatment for patients with a post-traumatic stress disorder or adjustment disorder after multiple ICD shocks. Design: Explorative feasibility study: Treatment of 22 patients as a natural design without randomisation and without control group. The period of recruitment was three years, from March 2007 to March 2010. The study consisted of two phases: in the first phase (pilot study) we tested different components and dosages of psychotherapeutic treatments. The final intervention programme is presented in this paper. In the second phase (follow-up study) we assessed the residual post-traumatic stress symptoms in these ICD patients. The time between treatment and follow-up measurement was 12 to 30 months. Population: Thirty-one patients were assigned to the Department of Psychocardiology after multiple shocks. The sample consisted of 22 patients who had a post-traumatic stress disorder or an adjustment disorder and were willing and able to participate. They were invited for psychological treatment. 18 of them could be included into the follow-up study. Methods: After the clinical assessment at the beginning and at the end of the inpatient treatment a post

High-intensity cardiac rehabilitation training of a firefighter after placement of an implantable cardioverter-defibrillator

PubMed Central

DeJong, Sandra; Arnett, Justin K.; Kennedy, Kathleen; Franklin, Jay O.; Berbarie, Rafic F.

2014-01-01

Firefighters who have received an implantable cardioverter-defibrillator (ICD) are asked to retire or are permanently placed on restricted duty because of concerns about their being incapacitated by an ICD shock during a fire emergency. We present the case of a 40-year-old firefighter who, after surviving sudden cardiac arrest and undergoing ICD implantation, sought to demonstrate his fitness for active duty by completing a high-intensity, occupation-specific cardiac rehabilitation training program. The report details the exercise training, ICD monitoring, and stress testing that he underwent. During the post-training treadmill stress test in firefighter turnout gear, the patient reached a functional capacity of 17 metabolic equivalents (METs), exceeding the 12-MET level required for his occupation. He had no ICD shock therapy or recurrent sustained arrhythmias during stress testing or at any time during his cardiac rehabilitation stay. By presenting this case, we hope to stimulate further discussion about firefighters who have an ICD, can meet the functional capacity requirements of their occupation, and want to return to work. PMID:24982569

High-intensity cardiac rehabilitation training of a firefighter after placement of an implantable cardioverter-defibrillator.

PubMed

Adams, Jenny; DeJong, Sandra; Arnett, Justin K; Kennedy, Kathleen; Franklin, Jay O; Berbarie, Rafic F

2014-07-01

Firefighters who have received an implantable cardioverter-defibrillator (ICD) are asked to retire or are permanently placed on restricted duty because of concerns about their being incapacitated by an ICD shock during a fire emergency. We present the case of a 40-year-old firefighter who, after surviving sudden cardiac arrest and undergoing ICD implantation, sought to demonstrate his fitness for active duty by completing a high-intensity, occupation-specific cardiac rehabilitation training program. The report details the exercise training, ICD monitoring, and stress testing that he underwent. During the post-training treadmill stress test in firefighter turnout gear, the patient reached a functional capacity of 17 metabolic equivalents (METs), exceeding the 12-MET level required for his occupation. He had no ICD shock therapy or recurrent sustained arrhythmias during stress testing or at any time during his cardiac rehabilitation stay. By presenting this case, we hope to stimulate further discussion about firefighters who have an ICD, can meet the functional capacity requirements of their occupation, and want to return to work.

Patients’ decision making to accept or decline an implantable cardioverter defibrillator for primary prevention of sudden cardiac death

PubMed Central

Carroll, Sandra L.; Strachan, Patricia H.; de Laat, Sonya; Schwartz, Lisa; Arthur, Heather M.

2011-01-01

Abstract Background  Patients are offered implantable defibrillators (ICDs) for the prevention of sudden cardiac death (SCD). However, patients’ decision‐making process (DMP) of whether or not to accept an ICD has not been explored. We asked patients about their decision making when offered an ICD. Design/Setting  A grounded theory methodology was employed. Patients were recruited from three ICD centres. Those who received an ICD underwent interviews the first month after implant. Declining patients had interviews at their convenience. In‐depth analysis of transcripts was completed. Identified themes were placed along process pathways in a DMP model and tested. Findings  Forty‐four patients consented to participate (25% women). Thirty‐four accepted an ICD and 10 (23%) declined. Ages ranged from 26 to 87 (mean = 65; SD = 12.5). Participants were retired (65%), had ischaemic heart disease (64%) and some post‐secondary education (52%). The DMP was triggered when patient’s risk for SCD was communicated. The physician’s recommendation and a new awareness SCD risk were motivators to accept the ICD. Patient’s decision‐making approaches fell along a continuum, from active and engaged to passive and indifferent. Patient’s approaches were influenced most by the following: (i) trust; (ii) social influences and (iii) health state. Conclusions  Health‐care providers need to recognize the DMP pathways in which ICD candidacy and SCD risk are understood. The factors that influence a patient’s decision warrant discussion pre‐implant. It is imperative that patients comprehend the meaning of ICD candidacy to make an informed decision. Participants did not recall alternatives to receiving ICD therapy. PMID:21645190

Evidence of Cognitive Bias in Decision Making Around Implantable-Cardioverter Defibrillators: A Qualitative Framework Analysis.

PubMed

Matlock, Daniel D; Jones, Jacqueline; Nowels, Carolyn T; Jenkins, Amy; Allen, Larry A; Kutner, Jean S

2017-11-01

Studies have demonstrated that patients with primary prevention implantable cardioverter-defibrillators (ICDs) often misunderstand the ICD. Advances in behavioral economics demonstrate that some misunderstandings may be due to cognitive biases. We aimed to explore the influence of cognitive bias on ICD decision making. We used a qualitative framework analysis including 9 cognitive biases: affect heuristic, affective forecasting, anchoring, availability, default effects, halo effects, optimism bias, framing effects, and state dependence. We interviewed 48 patients from 4 settings in Denver. The majority were male (n = 32). Overall median age was 61 years. We found frequent evidence for framing, default, and halo effects; some evidence of optimism bias, affect heuristic, state dependence, anchoring and availability bias; and little or no evidence of affective forecasting. Framing effects were apparent in overestimation of benefits and downplaying or omitting potential harms. We found evidence of cognitive bias in decision making for ICD implantation. The majority of these biases appeared to encourage ICD treatment. Published by Elsevier Inc.

Efficacy of implantable cardioverter defibrillators in young patients with catecholaminergic polymorphic ventricular tachycardia: success depends on substrate.

PubMed

Miyake, Christina Y; Webster, Gregory; Czosek, Richard J; Kantoch, Michal J; Dubin, Anne M; Avasarala, Kishor; Atallah, Joseph

2013-06-01

The effectiveness of implantable cardioverter-defibrillator (ICD) therapy for the management of catecholaminergic polymorphic ventricular tachycardia (VT) in young patients is not known. ICD discharges are not always effective and inappropriate discharges are common, both resulting in morbidity and mortality. This is a multicenter, retrospective review of young patients with catecholaminergic polymorphic VT and ICDs from 5 centers. ICD discharges were evaluated to determine arrhythmia mechanism, appropriateness, efficacy of therapy, and complications. A total of 24 patients were included. Median (interquartile range) ages at onset of catecholaminergic polymorphic VT symptoms and ICD implant were 10.6 (5.0-13.8) years and 13.7 (10.7-16.3) years, respectively. Fourteen patients received 140 shocks. Ten patients (42%) experienced 75 appropriate shocks and 11 patients (46%) received 65 inappropriate shocks. On actuarial analysis, freedom from appropriate shock at 1 year after ICD implant was 75%. Of appropriate shocks, only 43 (57%) demonstrated successful primary termination. All successful appropriate ICD discharges were for ventricular fibrillation. No episodes of polymorphic VT or bidirectional VT demonstrated successful primary termination. The adjusted mean (95% confidence interval) cycle length of successful discharges was significantly shorter than unsuccessful discharges (168 [152-184] ms versus 245 [229-262] ms; adjusted P=0.002). Electrical storm occurred in 29% (4/14) and induction of more malignant ventricular arrhythmias in 36% (5/14). There were no deaths. ICD efficacy in catecholaminergic polymorphic VT depends on arrhythmia mechanism. Episodes of ventricular fibrillation were uniformly successfully treated, whereas polymorphic and bidirectional VT did not demonstrate successful primary termination. Inappropriate shocks, electrical storm, and ICD complications were common.

Risk Factors and Temporal Trends of Complications Associated With Transvenous Implantable Cardiac Defibrillator Leads.

PubMed

Koneru, Jayanthi N; Jones, Paul W; Hammill, Eric F; Wold, Nicholas; Ellenbogen, Kenneth A

2018-05-10

The transvenous implantable cardioverter-defibrillator (ICD) lead is the most common source of complications in a traditional ICD system. This investigation aims to determine the incidence, predictors, and costs associated with these complications using a large insurance database. Data from the OptumLabs™ Data Warehouse, which include diagnosis, physician and procedure codes, and claims from patient hospitalizations, were analyzed. Patients with a de novo ICD or cardiac resynchronization therapy defibrillator implanted from January 1, 2003, through June 30, 2015, were included; those who did not have continuous coverage beginning 1 year before implantation were excluded, resulting in 40 837 patients followed up over an average of 2.3±2.1 years. Patients were followed up until they had the procedure or their last active date in the database. Of 20 580 device procedures, 2165 (5.3%) and 771 (1.9%) had mechanical and infectious complications, respectively. The 5-year rate of freedom from mechanical complication was 92.0% and 89.3% for ICDs and cardiac resynchronization therapy defibrillators, respectively. Infectious complications were more likely in patients with a history of atrial fibrillation, diabetes mellitus, and renal disease, and the risk increased with subsequent device procedures. Younger age, female sex, lack of comorbidities, and implantations between 2003 and 2008 were associated with more mechanical complications. Incidence of mechanical and infectious complications of transvenous ICD leads over long-term follow-up is much higher in the real world than in clinical studies. In our study cohort, 1 of 4 transvenous ICD leads had mechanical complications when followed up to 10 years. The high rate of reintervention leads to additional complications. © 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

Implantable cardioverter-defibrillators in adults with congenital heart disease: a systematic review and meta-analysis

PubMed Central

Vehmeijer, Jim T.; Brouwer, Tom F.; Limpens, Jacqueline; Knops, Reinoud E.; Bouma, Berto J.; Mulder, Barbara J.M.; de Groot, Joris R.

2016-01-01

Aims Sudden cardiac death is a major cause of mortality in adult congenital heart disease (ACHD) patients. The indications for implantable cardioverter-defibrillator (ICD) implantation in ACHD patients are still not well established. We aim to systematically review the literature on indications and outcome of ICD implantation in ACHD patients. Methods and results We performed a comprehensive search in EMBASE, MEDLINE, and Google Scholar to identify all studies on ICD implantation in ACHD patients. We used random effects models to calculate proportions and 95% confidence intervals. Of 1356 articles, 24 studies with 2162 patients were included, with a mean follow-up of 3.6 ± 0.9 years. Half of patients had tetralogy of Fallot. Mean age at implantation was 36.5 ± 5.5 years old and 66% was male. Implantable cardioverter-defibrillators were implanted for primary prevention in 53% (43.5–62.7). Overall, 24% (18.6–31.3) of patients received one or more appropriate ICD interventions (anti-tachycardia pacing or shocks) during 3.7 ± 0.9 years: 22% (16.9–28.8) of patients with primary prevention in 3.3 ± 0.3 years and 35% (26.6–45.2) of patients with secondary prevention in 4.3 ± 1.2 years. Inappropriate shocks occurred in 25% (20.1–31.0) in 3.7 ± 0.8 years and other, particularly lead-related complications in 26% (18.9–33.6) of patients in 3.8 ± 0.8 years. All-cause mortality was 10% during 3.7 ± 0.9 years. Conclusions In ACHD, remarkably high rates of appropriate ICD therapy were reported, both in primary and secondary prevention. Because of the young age and lower death rates, the cumulative beneficial effects are likely greater in ACHD patients than in acquired heart disease patients. However, considering the high rates of inappropriate shocks and complications, case-by-case weighing of costs and benefits, remains essential. PMID:26873095

Implanted Cardiac Defibrillator Care in Radiation Oncology Patient Population

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

Gelblum, Daphna Y.; Amols, Howard

2009-04-01

Purpose: To review the experience of a large cancer center with radiotherapy (RT) patients bearing implantable cardiac defibrillators (ICDs) to propose some preliminary care guidelines as we learn more about the devices and their interaction with the therapeutic radiation environment. Methods and Materials: We collected data on patients with implanted ICDs treated with RT during a 2.5-year period at any of the five Memorial Sloan-Kettering clinical campuses. Information regarding the model, location, and dose detected from the device, as well as the treatment fields, fraction size, and treatment energy was collected. During this time, a new management policy for thesemore » patients had been implemented requiring treatment with low-energy beams (6 MV) and close surveillance of the patients in partnership with their electrophysiologist, as they received RT. Results: During the study period, 33 patients were treated with an ICD in place. One patient experienced a default of the device to its initial factory setting that was detected by the patient hearing an auditory signal from the device. This patient had initially been treated with a 15-MV beam. After this episode, his treatment was replanned to be completed with 6-MV photons, and he experienced no further events. Conclusion: Patients with ICDs and other implanted computer-controlled devices will be encountered more frequently in the RT department, and proper management is important. We present a policy for the safe treatment of these patients in the radiation oncology environment.« less

Posttraumatic stress 18 months following cardioverter defibrillator implantation: shocks, anxiety, and personality.

PubMed

Habibović, Mirela; van den Broek, Krista C; Alings, Marco; Van der Voort, Pepijn H; Denollet, Johan

2012-03-01

Posttraumatic stress disorder (PTSD) has been observed in cardiac patients, but little is known about PTSD in implantable cardioverter defibrillator (ICD) patients. We examined the prevalence and predictors (clinical variables, personality, and anxiety) of PTSD in ICD patients. Three hundred ninety-five ICD patients (20.1% female; mean age = 62.8 ± 10.3 years) from two Dutch referral hospitals completed the 14-item Type D scale (DS14) and the State-Trait Anxiety Inventory to assess Type D (distressed) personality (high negative affect with social inhibition) and anxiety (on the State Anxiety Inventory) at the time of implantation. Logistic regression analysis was performed to identify independent predictors of PTSD at 18 months postimplantation. At 18 months postimplantation, 30 patients (7.6%) qualified for a PTSD diagnosis. Of these patients, 55% (n = 16) had a Type D personality, 83% (n = 25) experienced anxiety at baseline, and 24% (n = 7) had experienced shocks during follow-up. Both Type D personality (odds ratio [OR] = 3.5) and baseline anxiety (OR = 4.3) were significant predictors of posttraumatic stress at 18 months postimplantation, independent of shocks and other clinical and demographic covariates. Shocks were not significantly associated with PTSD. A significant group of ICD patients is at risk of posttraumatic stress 18 months postimplantation, especially Type D patients and patients with increased levels of baseline anxiety. Identification of patients with Type D personality and anxiety at the time of implantation may be warranted to prevent PTSD in ICD patients.

Development of an expert based ICD-9-CM and ICD-10-CM map to AIS 2005 update 2008.

PubMed

Loftis, Kathryn L; Price, Janet P; Gillich, Patrick J; Cookman, Kathy J; Brammer, Amy L; St Germain, Trish; Barnes, Jo; Graymire, Vickie; Nayduch, Donna A; Read-Allsopp, Christine; Baus, Katherine; Stanley, Patsye A; Brennan, Maureen

2016-09-01

This article describes how maps were developed from the clinical modifications of the 9th and 10th revisions of the International Classification of Diseases (ICD) to the Abbreviated Injury Scale 2005 Update 2008 (AIS08). The development of the mapping methodology is described, with discussion of the major assumptions used in the process to map ICD codes to AIS severities. There were many intricacies to developing the maps, because the 2 coding systems, ICD and AIS, were developed for different purposes and contain unique classification structures to meet these purposes. Experts in ICD and AIS analyzed the rules and coding guidelines of both injury coding schemes to develop rules for mapping ICD injury codes to the AIS08. This involved subject-matter expertise, detailed knowledge of anatomy, and an in-depth understanding of injury terms and definitions as applied in both taxonomies. The official ICD-9-CM and ICD-10-CM versions (injury sections) were mapped to the AIS08 codes and severities, following the rules outlined in each coding manual. The panel of experts was composed of coders certified in ICD and/or AIS from around the world. In the process of developing the map from ICD to AIS, the experts created rules to address issues with the differences in coding guidelines between the 2 schemas and assure a consistent approach to all codes. Over 19,000 ICD codes were analyzed and maps were generated for each code to AIS08 chapters, AIS08 severities, and Injury Severity Score (ISS) body regions. After completion of the maps, 14,101 (74%) of the eligible 19,012 injury-related ICD-9-CM and ICD-10-CM codes were assigned valid AIS08 severity scores between 1 and 6. The remaining 4,911 codes were assigned an AIS08 of 9 (unknown) or were determined to be nonmappable because the ICD description lacked sufficient qualifying information for determining severity according to AIS rules. There were also 15,214 (80%) ICD codes mapped to AIS08 chapter and ISS body region, which

Utilization rates of implantable cardioverter-defibrillators for primary prevention of sudden cardiac death: a 2012 calculation for a midwestern health referral region.

PubMed

Hoang, Allen; Shen, Changyu; Zheng, James; Taylor, Stanley; Groh, William J; Rosenman, Marc; Buxton, Alfred E; Chen, Peng-Sheng

2014-05-01

Utilization rates (URs) for implantable cardioverter-defibrillators (ICDs) for primary prevention of sudden cardiac death (PPSCD) are lacking in the community. The purpose of this study was to establish the ICD UR in central Indiana. A query run on 2 hospitals in a health information exchange database in Indianapolis identified patients between 2011 and 2012 with left ventricular ejection fraction (EF) ≤0.35. ICD eligibility and utilization were determined from chart review. We identified 1863 patients with at least 1 low EF study. Two cohorts were analyzed: 1672 patients without and 191 patients with International Classification of Diseases, Ninth Revision, Clinical Modification procedure code 37.94 for ICD placement. We manually reviewed a stratified (by hospital) random sample of 300 patients from the no-ICD procedure code cohort and found that 48 (16%) had no ICD but had class I indications for ICD. Eight of 300 (2.7%) actually had ICD implantation for PPSCD. Review of all 191 patients in the ICD procedure code cohort identified 70 with ICD implantation for PPSCD. The ICD UR (ratio between patients with ICD for PPSCD and all with indication) was 38% overall (95% confidence interval [CI] 28%-49%). URs were 48% for males (95% CI 34%-61%), 21% for females (95% CI 16%-26%, P = .0002 vs males), 40% for whites (95% CI 27%-53%), and 37% for blacks (95% CI 28%-46%, P = .66 vs whites). ICD UR is 38% among patients meeting class I indications, suggesting further opportunities for improving guideline compliance. This study also illustrates limitations in calculating ICD UR using large electronic repositories without hands-on chart review. Copyright © 2014 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Predicting in-hospital mortality of traffic victims: A comparison between AIS-and ICD-9-CM-related injury severity scales when only ICD-9-CM is reported.

PubMed

Van Belleghem, Griet; Devos, Stefanie; De Wit, Liesbet; Hubloue, Ives; Lauwaert, Door; Pien, Karen; Putman, Koen

2016-01-01

Injury severity scores are important in the context of developing European and national goals on traffic safety, health-care benchmarking and improving patient communication. Various severity scores are available and are mostly based on Abbreviated Injury Scale (AIS) or International Classification of Diseases (ICD). The aim of this paper is to compare the predictive value for in-hospital mortality between the various severity scores if only International Classification of Diseases, 9th revision, Clinical Modification ICD-9-CM is reported. To estimate severity scores based on the AIS lexicon, ICD-9-CM codes were converted with ICD Programmes for Injury Categorization (ICDPIC) and four AIS-based severity scores were derived: Maximum AIS (MaxAIS), Injury Severity Score (ISS), New Injury Severity Score (NISS) and Exponential Injury Severity Score (EISS). Based on ICD-9-CM, six severity scores were calculated. Determined by the number of injuries taken into account and the means by which survival risk ratios (SRRs) were calculated, four different approaches were used to calculate the ICD-9-based Injury Severity Scores (ICISS). The Trauma Mortality Prediction Model (TMPM) was calculated with the ICD-9-CM-based model averaged regression coefficients (MARC) for both the single worst injury and multiple injuries. Severity scores were compared via model discrimination and calibration. Model comparisons were performed separately for the severity scores based on the single worst injury and multiple injuries. For ICD-9-based scales, estimation of area under the receiver operating characteristic curve (AUROC) ranges between 0.94 and 0.96, while AIS-based scales range between 0.72 and 0.76, respectively. The intercept in the calibration plots is not significantly different from 0 for MaxAIS, ICISS and TMPM. When only ICD-9-CM codes are reported, ICD-9-CM-based severity scores perform better than severity scores based on the conversion to AIS. Copyright © 2015 Elsevier Ltd. All

The effect of ICD programming on inappropriate and appropriate ICD Therapies in ischemic and nonischemic cardiomyopathy: the MADIT-RIT trial.

PubMed

Sedláček, Kamil; Ruwald, Anne-Christine; Kutyifa, Valentina; McNitt, Scott; Thomsen, Poul Erik Bloch; Klein, Helmut; Stockburger, Martin; Wichterle, Dan; Merkely, Bela; DE LA Concha, Joaquin Fernandez; Swissa, Moshe; Zareba, Wojciech; Moss, Arthur J; Kautzner, Josef; Ruwald, Martin H

2015-04-01

The MADIT-RIT trial demonstrated reduction of inappropriate and appropriate ICD therapies and mortality by high-rate cut-off and 60-second-delayed VT therapy ICD programming in patients with a primary prophylactic ICD indication. The aim of this analysis was to study effects of MADIT-RIT ICD programming in patients with ischemic and nonischemic cardiomyopathy. First and total occurrences of both inappropriate and appropriate ICD therapies were analyzed by multivariate Cox models in 791 (53%) patients with ischemic and 707 (47%) patients with nonischemic cardiomyopathy. Patients with ischemic and nonischemic cardiomyopathy had similar incidence of first inappropriate (9% and 11%, P = 0.21) and first appropriate ICD therapy (11.6% and 14.1%, P = 0.15). Patients with ischemic cardiomyopathy had higher mortality rate (6.1% vs. 3.3%, P = 0.01). MADIT-RIT high-rate cut-off (arm B) and delayed VT therapy ICD programming (arm C) compared with conventional (arm A) ICD programming were associated with a significant risk reduction of first inappropriate and appropriate ICD therapy in patients with ischemic and nonischemic cardiomyopathy (HR range 0.11-0.34, P < 0.001 for all comparisons). Occurrence of total inappropriate and appropriate ICD therapies was significantly reduced by high-rate cut-off ICD programming and delayed VT therapy ICD programming in both ischemic and nonischemic cardiomyopathy patients. High-rate cut-off and delayed VT therapy ICD programming are associated with significant reduction in first and total inappropriate and appropriate ICD therapy in patients with ischemic and nonischemic cardiomyopathy. © 2014 Wiley Periodicals, Inc.

Long-Term Evaluation of Biotronik Linox and Linox(smart) Implantable Cardioverter Defibrillator Leads.

PubMed

Good, Eric D; Cakulev, Ivan; Orlov, Michael V; Hirsh, David; Simeles, John; Mohr, Kelly; Moll, Phil; Bloom, Heather

2016-06-01

Expert consensus holds that post-market, systematic surveillance of ICD leads is essential to ensure confirmation of adequate lead performance. GALAXY (NCT00836589) and CELESTIAL (NCT00810264) are ongoing multicenter, prospective, non-randomized registries conducted to confirm the long-term safety and reliability of Biotronik leads. ICD and CRT-D patients are followed for Linox and Linox(smart) ICD lead performance and safety for 5 years post-implant. All procedural and system-related adverse events (AEs) were assessed at each follow-up, along with lead electrical parameters. An independent CEC of EPs adjudicated AEs to determine AE category and lead relatedness. The analysis used categories of lead observations per ISO 5841-2 (Third edition). A total of 3,933 leads were implanted in 3,840 patients (73.0% male, mean age 67.0 ± 12.2 years) at 146 US centers. The estimated cumulative survival probability was 96.3% at 5 years after implant for Linox leads and 96.6% at 4 years after implant for Linox(smart) leads. A comparison of the Linox and Linox(smart) survival functions did not find evidence of a difference (P = 0.2155). The most common AEs were oversensing (23, 0.58%), conductor fracture (14, 0.36%), failure to capture (13, 0.33%), lead dislodgement (12, 0.31%), insulation breach (10, 0.25%), and abnormal pacing impedance (8, 0.20%). Linox and Linox(smart) ICD leads are safe, reliable and infrequently associated with lead-related AEs. Additionally, estimated cumulative survival probability is clinically acceptable and well within industry standards. Ongoing data collection will confirm the longer-term safety and performance of the Linox family of ICD leads. © 2016 Wiley Periodicals, Inc.

Leisure-time activities of patients with ICDs: findings of a survey with respect to sports activity, high altitude stays, and driving patterns.

PubMed

Kobza, Richard; Duru, Firat; Erne, Paul

2008-07-01

Physicians who are caring for patients with implantable cardioverter-defibrillators (ICDs) are regularly confronted with questions concerning daily activities. This study evaluates the habits of ICD patients with respect to sports activities, stays at high-altitude, and driving patterns. A survey was performed in 387 patients with ICDs who were followed at two hospitals in Switzerland. The special-designed questionnaire addressed lifestyle practices concerning sports activity, high-altitude visits, and driving motor vehicles. Fifty-nine percent of ICD patients participated in some kind of sports activity; an ICD shock was experienced in 14% of these patients. Fifty-six percent of the patients reported a stay at high altitudes at least 2,000 m above the sea level; 11% of them stayed regularly above 2,500 m; 4% of these patients experienced an ICD shock during high altitude stay. Seventy-nine percent of the patients drove a motor vehicle; 2% of them experienced an ICD shock during driving, but none of them reported loss of consciousness or a traffic accident. It is accepted that ICD patients disqualify for competitive sports. However, the patients may be encouraged to continue leisure-time physical activities at low-to-moderate intensity. Staying at high altitudes and driving motor vehicles are very rarely associated with ICD shocks. Therefore, these activities that are likely to contribute to a better quality of life should not be discouraged in most ICD recipients in the absence of other medical reasons.

Consensus statement of the European Heart Rhythm Association: updated recommendations for driving by patients with implantable cardioverter defibrillators.

PubMed

Vijgen, Johan; Botto, Gianluca; Camm, John; Hoijer, Carl-Johan; Jung, Werner; Le Heuzey, Jean-Yves; Lubinski, Andrzej; Norekvål, Tone M; Santomauro, Maurizio; Schalij, Martin; Schmid, Jean-Paul; Vardas, Panos

2010-03-01

Patients with an implantable cardioverter defibrillator (ICD) have an ongoing risk of sudden incapacitation that might cause harm to others while driving a car. Driving restrictions vary across different countries in Europe. The most recent recommendations for driving of ICD patients in Europe were published in 1997 and focused mainly on patients implanted for secondary prevention. In recent years there has been a vast increase in the number of patients with an ICD and in the percentage of patients implanted for primary prevention. The EHRA task force on ICD and driving was formed to reassess the risk of driving for ICD patients based on the literature available. The recommendations are summarized in the following table and are further explained in the document, (Table see text). Driving restrictions are perceived as difficult for patients and their families, and have an immediate consequence for their lifestyle. To increase the adherence to the driving restrictions, adequate discharge of education and follow-up of patients and family are pivotal. The task force members hope this document may serve as an instrument for European and national regulatory authorities to formulate uniform driving regulations. Copyright (c) 2010 Elsevier B.V. All rights reserved.

Consensus statement of the European Heart Rhythm Association: updated recommendations for driving by patients with implantable cardioverter defibrillators.

PubMed

Vijgen, Johan; Botto, Gianluca; Camm, John; Hoijer, Carl-Johan; Jung, Werner; Le Heuzey, Jean-Yves; Lubinski, Andrzej; Norekvål, Tone M; Santomauro, Maurizio; Schalij, Martin; Schmid, Jean-Paul; Vardas, Panos

2009-08-01

Patients with an implantable cardioverter defibrillator (ICD) have an ongoing risk of sudden incapacitation that might cause harm to others while driving a car. Driving restrictions vary across different countries in Europe. The most recent recommendations for driving of ICD patients in Europe were published in 1997 and focused mainly on patients implanted for secondary prevention. In recent years there has been a vast increase in the number of patients with an ICD and in the percentage of patients implanted for primary prevention. The EHRA task force on ICD and driving was formed to reassess the risk of driving for ICD patients based on the literature available. The recommendations are summarized in the following table and are further explained in the document. [table: see text] Driving restrictions are perceived as difficult for patients and their families, and have an immediate consequence for their lifestyle. To increase the adherence to the driving restrictions, adequate discharge of education and follow-up of patients and family are pivotal. The task force members hope this document may serve as an instrument for European and national regulatory authorities to formulate uniform driving regulations.

ICD-10 procedure codes produce transition challenges

PubMed Central

Boyd, Andrew D.; Li, Jianrong ‘John’; Kenost, Colleen; Zaim, Samir Rachid; Krive, Jacob; Mittal, Manish; Satava, Richard A.; Burton, Michael; Smith, Jacob; Lussier, Yves A.

2018-01-01

The transition of procedure coding from ICD-9-CM-Vol-3 to ICD-10-PCS has generated problems for the medical community at large resulting from the lack of clarity required to integrate two non-congruent coding systems. We hypothesized that quantifying these issues with network topology analyses offers a better understanding of the issues, and therefore we developed solutions (online tools) to empower hospital administrators and researchers to address these challenges. Five topologies were identified: “identity”(I), “class-to-subclass”(C2S), “subclass-toclass”(S2C), “convoluted(C)”, and “no mapping”(NM). The procedure codes in the 2010 Illinois Medicaid dataset (3,290 patients, 116 institutions) were categorized as C=55%, C2S=40%, I=3%, NM=2%, and S2C=1%. Majority of the problematic and ambiguous mappings (convoluted) pertained to operations in ophthalmology cardiology, urology, gyneco-obstetrics, and dermatology. Finally, the algorithms were expanded into a user-friendly tool to identify problematic topologies and specify lists of procedural codes utilized by medical professionals and researchers for mitigating error-prone translations, simplifying research, and improving quality.http://www.lussiergroup.org/transition-to-ICD10PCS PMID:29888037

ICD-10 procedure codes produce transition challenges.

PubMed

Boyd, Andrew D; Li, Jianrong 'John'; Kenost, Colleen; Zaim, Samir Rachid; Krive, Jacob; Mittal, Manish; Satava, Richard A; Burton, Michael; Smith, Jacob; Lussier, Yves A

2018-01-01

The transition of procedure coding from ICD-9-CM-Vol-3 to ICD-10-PCS has generated problems for the medical community at large resulting from the lack of clarity required to integrate two non-congruent coding systems. We hypothesized that quantifying these issues with network topology analyses offers a better understanding of the issues, and therefore we developed solutions (online tools) to empower hospital administrators and researchers to address these challenges. Five topologies were identified: "identity"(I), "class-to-subclass"(C2S), "subclass-toclass"(S2C), "convoluted(C)", and "no mapping"(NM). The procedure codes in the 2010 Illinois Medicaid dataset (3,290 patients, 116 institutions) were categorized as C=55%, C2S=40%, I=3%, NM=2%, and S2C=1%. Majority of the problematic and ambiguous mappings (convoluted) pertained to operations in ophthalmology cardiology, urology, gyneco-obstetrics, and dermatology. Finally, the algorithms were expanded into a user-friendly tool to identify problematic topologies and specify lists of procedural codes utilized by medical professionals and researchers for mitigating error-prone translations, simplifying research, and improving quality.http://www.lussiergroup.org/transition-to-ICD10PCS.

Evaluation of acute cardiac and chest wall damage after shocks with a subcutaneous implantable cardioverter defibrillator in Swine.

PubMed

Killingsworth, Cheryl R; Melnick, Sharon B; Litovsky, Silvio H; Ideker, Raymond E; Walcott, Gregory P

2013-10-01

A subcutaneous implantable cardioverter defibrillator (S-ICD) could ease placement and reduce complications of transvenous ICDs, but requires more energy than transvenous ICDs. Therefore we assessed cardiac and chest wall damage caused by the maximum energy shocks delivered by both types of clinical devices. During sinus rhythm, anesthetized pigs (38 ± 6 kg) received an S-ICD (n = 4) and five 80-Joule (J) shocks, or a transvenous ICD (control, n = 4) and five 35-J shocks. An inactive S-ICD electrode was implanted into the same control pigs to study implant trauma. All animals survived 24 hours. Troponin I and creatine kinase muscle isoenzyme (CK-MM) were measured as indicators of myocardial and skeletal muscle injury. Histopathological injury of heart, lungs, and chest wall was assessed using semiquantitative scoring. Troponin I was significantly elevated at 4 hours and 24 hours (22.6 ± 16.3 ng/mL and 3.1 ± 1.3 ng/mL; baseline 0.07 ± 0.09 ng/mL) in control pigs but not in S-ICD pigs (0.12 ± 0.11 ng/mL and 0.13 ± 0.13 ng/mL; baseline 0.06 ± 0.03 ng/mL). CK-MM was significantly elevated in S-ICD pigs after shocks (6,544 ± 1,496 U/L and 9,705 ± 6,240 U/L; baseline 704 ± 398 U/L) but not in controls. Electrocardiogram changes occurred postshock in controls but not in S-ICD pigs. The myocardium and lungs were histologically normal in both groups. Subcutaneous injury was greater in S-ICD compared to controls. Although CK-MM suggested more skeletal muscle injury in S-ICD pigs, significant cardiac, lung, and chest wall histopathological changes were not detected in either group. Troponin I data indicate significantly less cardiac injury from 80-J S-ICD shocks than 35-J transvenous shocks. ©2013, The Authors. Journal compilation ©2013 Wiley Periodicals, Inc.

Implantable Medical Devices

MedlinePlus

... Also known as ICD ) - An ICD is a battery-powered device placed under the skin that keeps ... Pacemaker (Also known as Artificial Pacemaker) - A small battery-operated device that helps the heart beat in ...

Overview of implantable cardioverter defibrillator and cardiac resynchronisation therapy in heart failure management

PubMed Central

Chia, Pow-Li; Foo, David

2016-01-01

Clinical trials have established the benefits of implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy (CRT) in the treatment of heart failure patients. As adjuncts to guideline-directed medical therapy, ICDs confer mortality benefits from sudden cardiac arrest, while CRT reduces mortality, hospitalisation rates and improves functional capacity. This review discusses the use of ICDs and CRT devices in heart failure management, outlining the evidence supporting their use, indications and contraindications. PMID:27440409

Mortality reduction in relation to implantable cardioverter defibrillator programming in the Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT).

PubMed

Ruwald, Anne-Christine; Schuger, Claudio; Moss, Arthur J; Kutyifa, Valentina; Olshansky, Brian; Greenberg, Henry; Cannom, David S; Estes, N A Mark; Ruwald, Martin H; Huang, David T; Klein, Helmut; McNitt, Scott; Beck, Christopher A; Goldstein, Robert; Brown, Mary W; Kautzner, Josef; Shoda, Morio; Wilber, David; Zareba, Wojciech; Daubert, James P

2014-10-01

The benefit of novel implantable cardioverter defibrillator (ICD) programming in reducing inappropriate ICD therapy and mortality was demonstrated in Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT). However, the cause of mortality reduction remains incompletely evaluated. We aimed to identify factors associated with mortality, with focus on ICD therapy and programming in the MADIT-RIT population. In MADIT-RIT, 1500 patients with a primary prophylactic indication for ICD or cardiac resynchronization therapy with defibrillator were randomized to 1 of 3 different ICD programming arms: conventional programming (ventricular tachycardia zone ≥170 beats per minute), high-rate programming (ventricular tachycardia zone ≥200 beats per minute), and delayed programming (60-second delay before therapy ≥170 beats per minute). Multivariate Cox models were used to assess the influence of time-dependent appropriate and inappropriate ICD therapy (shock and antitachycardia pacing) and randomized programming arm on all-cause mortality. During an average follow-up of 1.4±0.6 years, 71 of 1500 (5%) patients died: cardiac in 40 patients (56.3%), noncardiac in 23 patients (32.4%), and unknown in 8 patients (11.3%). Appropriate shocks (hazard ratio, 6.32; 95% confidence interval, 3.13-12.75; P<0.001) and inappropriate therapy (hazard ratio, 2.61; 95% confidence interval, 1.28-5.31; P=0.01) were significantly associated with an increased mortality risk. There was no evidence of increased mortality risk in patients who experienced appropriate antitachycardia pacing only (hazard ratio, 1.02; 95% confidence interval, 0.36-2.88; P=0.98). Randomization to conventional programming was identified as an independent predictor of death when compared with patients randomized to high-rate programming (hazard ratio, 2.0; 95% confidence interval, 1.06-3.71; P=0.03). In MADIT-RIT, appropriate shocks, inappropriate ICD therapy, and randomization to

Towards evidence-based emergency medicine: Best BETs from the Manchester Royal Infirmary. BET 2: Is there value in testing troponin levels after ICD discharge?

PubMed

Targett, Chris; Harris, Tim

2014-03-01

A short cut review was carried out to establish whether testing for troponin levels is useful after discharge of an Implanted Cardioverter-Defibrillator (ICD). Many papers were found using the reported searches, none of which directly addressed the problem but some 13 presented the best evidence to answer the clinical question. The author, date and country of publication, patient group studied, study type, relevant outcomes, results and study weaknesses of those best papers are tabulated. It is concluded that the number of ICD discharges must be taken into account when evaluating any troponin level rise. Overall a positive troponin assay post ICD discharge is independently associated with an increased mortality.

Beta-blocker therapy is not associated with symptoms of depression and anxiety in patients receiving an implantable cardioverter-defibrillator.

PubMed

Hoogwegt, Madelein T; Kupper, Nina; Theuns, Dominic A M J; Jordaens, Luc; Pedersen, Susanne S

2012-01-01

Beta-blockers are frequently prescribed to implantable cardioverter-defibrillator (ICD) patients. Beta-blocker therapy has been proposed to induce emotional distress such as depression and anxiety, but a paucity of studies has examined the relationship between beta-blockers and distress. We investigated the association between beta-blocker therapy, including type and dosage, and symptoms of anxiety and depression in a consecutive cohort of patients receiving an ICD. Between 2003 and 2010, 448 consecutively implanted ICD patients were enrolled in the prospective Mood and personality as precipitants of arrhythmia in patients with an Implantable cardioverter Defibrillator: A prospective Study (MIDAS), of which 429 completed the Hospital Anxiety and Depression Scale (HADS) and the ICD Patient Concerns questionnaire (ICDC) at baseline. Eighty per cent of all patients received beta-blocker therapy. In univariate analysis, beta-blocker therapy was not significantly associated with symptoms of anxiety, depression, and ICD concerns (β = -0.030, β = 0.007, and β = -0.045, respectively; all P's >0.36). Type of beta-blocker showed a trend towards significance for mean levels of ICD concerns (P = 0.09). No association was found between dosage and emotional distress (all P's >0.21). After adjustment for relevant clinical and demographic variables, the association of beta-blocker therapy and symptoms of anxiety, depression, and ICD concerns remained non-significant (β = 0.009, β = 0.037, and β = 0.019, respectively; all P's >0.47). In patients receiving an ICD, beta-blocker therapy was not associated with symptoms of anxiety, depression, and ICD concerns. Research is warranted that further elucidates the link between beta-blocker therapy and emotional distress in this vulnerable patient group.

Impact of a hybrid decision support system to improve the adherence to implantable cardioverter defibrillator therapy guidelines for primary prevention of sudden cardiac death.

PubMed

Vecchio, Nicolás; Belardi, Diego; Benzadón, Mariano; Seoane, Leonardo; Daquarti, Gustavo; Scazzuso, Fernando

2018-06-01

Despite the well-documented benefit of implantable cardioverter defibrillator (ICD) in patients with severe left ventricular dysfunction, there is a large number of patients who had not been offered this therapy. The aim of this study is to evaluate the utility of a hybrid decision support system (hCDSS) to improve the adherence to indicate ICD therapy in our institution. We conducted a retrospective, observational and single-center study. An hCDSS focused on patients with severe deterioration of the left ventricular function was implemented, creating a mandatory field containing the value of left ejection fraction and three options to choose: >35%, ≤ 35% or unknown. When the option ≤ 35% is checked, an email is automatically sent to the electrophysiology section where the staff can contact the treating physician to discuss the indication of ICD therapy. We measured the number of ICDs implanted before the alert (month 1-21), immediate post and late post alert (month 22-27 and 28-48 months respectively) RESULTS: The rate of ICD implantation increased from 1.76% per month in the pre-intervention period to 4.48% after the intervention (p < 0.001). This increase in the rate of ICD implantation remained stable between the immediate and late post-intervention period (4.6 vs. 4.4; p = .8) CONCLUSION: The implementation of a hybrid decision support system was associated with improved adherence to clinical guidelines for prevention of sudden cardiac death, as evidenced by a rapid and sustained increase in the number of ICD implants in patients with severe left ventricular dysfunction. Copyright © 2018 Elsevier B.V. All rights reserved.

[Clinical development of the automatic implantable defibrillator over 35 years: A success story].

PubMed

Steinbeck, G

2015-06-01

After 12 years of development and experimental evaluation, the first automatic implantable cardioverter-defibrillator (ICD) was implanted in man on February 4, 1980. This overview describes the technical and functional developments over 35 years from a simple shock-box, weighing 292 g, to the sophisticated 80 g device of today, delivering graded therapy to sustained ventricular arrhythmias and biventricular stimulation to treat heart failure. Finally, a special tribute is given to Michel Mirowski, one of the inventors of the ICD, as scientist and physician dedicated to patient care.

Neutrophil to lymphocyte ratio predicts appropriate therapy in idiopathic dilated cardiomyopathy patients with primary prevention implantable cardioverter defibrillator

PubMed Central

Uçar, Fatih M.; Açar, Burak

2017-01-01

Objectives: To investigate whether an inflammatory marker of neutrophil to lymphocyte ratio (NLR) predicts appropriate implantable cardioverter defibrillator (ICD) therapy (shock or anti tachycardia pacing) in idiopathic dilated cardiomyopathy (IDC) patients. Methods: We retrospectively examined IDC patients (mean age: 58.3 ± 11.8 years, 81.5% male) with ICD who admitted to outpatient clinic for pacemaker control at 2 tertiary care hospitals in Ankara and Edirne, Turkey from January 2013-2015. All ICDs were implanted for primary prevention. Hematological and biochemical parameters were measured prior procedure. Results: Over a median follow-up period of 43 months (Range 7-125), 68 (33.1%) patients experienced appropriate ICD therapy. The NLR was increased in patients that received appropriate therapy (4.39 ± 2.94 versus 2.96 ± 1.97, p<0.001). To identify independent risk factors for appropriate therapy, a multivariate linear regression model was conducted and age (β=0.163, p=0.013), fasting glucose (β=0.158, p=0.017), C-reactive protein (CRP) (β=0.289, p<0.001) and NLR (β=0.212, p<0.008) were found to be independent risk factors for appropriate ICD therapy. Conclusions: Before ICD implantation by using NLR and CRP, arrhythmic episodes may be predictable and better antiarrhythmic medical therapy optimization may protect these IDC patients from unwanted events. PMID:28133686

Prognostic role of post-infarction C-reactive protein in patients undergoing implantation of cardioverter-defibrillators: design of the C-reactive protein Assessment after Myocardial Infarction to GUide Implantation of DEfibrillator (CAMI GUIDE) study.

PubMed

Bellocci, Fulvio; Biasucci, Luigi M; Gensini, Gian Franco; Padeletti, Luigi; Raviele, Antonio; Santini, Massimo; Giubilato, Giovanna; Landolina, Maurizio; Biondi-Zoccai, Giuseppe; Raciti, Giovanni; Sassara, Massimo; Castro, Antonello; Kheir, Antoine; Crea, Filippo

2007-04-01

Patients at risk of sudden cardiac death (SCD) after myocardial infarction (MI) can currently be offered effective means of prevention, such as implantable cardioverter-defibrillators (ICD). However, predictors of SCD able to identify those patients who are at higher risk are still lacking. Whether C-reactive protein (CRP), a serum inflammatory marker with established prognostic accuracy after MI, can also be a predictor of SCD is unclear. The CAMI GUIDE study is designed to evaluate the prognostic role of CRP in patients undergoing ICD implantation after MI according to MADIT II criteria (i.e. left ventricular ejection fractionICD implantation; clinical follow-up will last 24 months. The primary endpoint is the combined rate of SCD or fast ventricular tachycardia/ventricular fibrillation. Secondary endpoints will be total mortality, death due to acute coronary syndromes, death from pump failure, non-fatal MI, coronary revascularization, hospitalization for congestive heart failure or unstable angina and inappropriate ICD shocks. Twenty-four Italian centers will participate in enrollment of the 290 patients planned according to power analysis. The CAMI GUIDE study will assess the predictive role of CRP in SCD in patients with previous MI undergoing ICD implantation. Its results will improve risk stratification, thereby enabling better-tailored and more cost-effective therapies to be undertaken in those patients whose need is greatest.

Do women benefit equally as men from the primary prevention implantable cardioverter-defibrillator?

PubMed

Barra, Sérgio; Providência, Rui; Boveda, Serge; Narayanan, Kumar; Virdee, Munmohan; Marijon, Eloi; Agarwal, Sharad

2018-06-01

Women traditionally have been and are still underrepresented in research in many important areas of cardiology, and guideline recommendations which also encompass women are mostly based on research conducted predominantly in men. However, there is plausible cause to believe that sex may have a potential influence on the benefit derived from the implantable cardioverter-defibrillators (ICD), alone or in association with cardiac resynchronization therapy. We assessed the possible relationship between sex and outcome with ICD implantation in the setting of primary prevention, by pooling the results of MUSTT, MADIT-II, DEFINITE, COMPANION, SCD-HeFT and DANISH trials in a meta-analysis. We pooled results for female and male patients separately. The results suggest that women as a group do not seem to obtain a significant survival benefit from the primary prevention ICD, contrary to men. This in turn may also have contributed to a relative underestimation of the ICD benefit among males when looking at the results in total. It is time for the medical and research communities to actively question the presumed overarching benefit of ICDs irrespective of sex and engage in systematic scientific efforts to definitively evaluate the value of this intervention in women.

Dual- vs. single-chamber defibrillators for primary prevention of sudden cardiac death: long-term follow-up of the Défibrillateur Automatique Implantable-Prévention Primaire registry.

PubMed

Defaye, Pascal; Boveda, Serge; Klug, Didier; Beganton, Frankie; Piot, Olivier; Narayanan, Kumar; Périer, Marie-Cécile; Gras, Daniel; Fauchier, Laurent; Bordachar, Pierre; Algalarrondo, Vincent; Babuty, Dominique; Deharo, Jean-Claude; Leclercq, Christophe; Marijon, Eloi; Sadoul, Nicolas

2017-09-01

Implantable cardioverter defibrillators (ICDs) are an effective primary prevention of sudden cardiac death. We examined whether dual-chamber (DC) ICDs confer a greater benefit than single-chamber (SC) ICDs, and compared the long-term outcomes of recipients of each type of device implanted for primary prevention. Between 2002 and 2012, the DAI-PP registry consecutively enrolled 1258 SC- and 1280 DC-ICD recipients at 12 French medical centres. The devices were interrogated at 4- to 6-month intervals during outpatient visits, with a focus on the therapies delivered. The study endpoints were incidence of appropriate therapies, ICD-related morbidity, and deaths from all and from specific causes. The mean age of the SC- and DC-ICD recipients was 59 ± 12 and 62 ± 11 years, respectively (P< 0.0001). The distribution of genders, New York Heart Association functional classes and glomerular filtration rates, and the rates of ischaemic vs. dilated cardiomyopathies and of defibrillation tests at implant, were similar in both study groups. The rates of periprocedural complications were 12.1% in the DC- vs. 8.8% in the SC-ICD groups (P= 0.008). Over a mean follow-up of 3.1 ± 2.2 years, pulse generators were replaced in 21.9% of the DC- vs. 13.6% of the SC-ICD group (P< 0.0001). The proportions of patients treated with ≥1 appropriate therapies (24.7 vs. 23.8%) and ≥1 inappropriate shocks (8.4 vs. 7.8%), and all-cause mortality (12.4 vs. 13.2%) were similar in both groups. In this large registry of ICD implanted for primary prevention, DC-ICDs were associated with higher rates of peri-implant complications and generator replacements, whereas the survival and rates of inappropriate shocks were similar in both groups. NCT#01992458. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions please email: journals.permissions@oup.com.

The benefits of remote monitoring in long-term care for patients with implantable cardioverter-defibrillators.

PubMed

Ošmera, Ondřej; Bulava, Alan

2014-01-01

The increasing number of patients with implantable cardiac devices raises the need for more efficient outpatient follow-up care. Due to technological progress in communication and transmission systems and in the implantable devices themselves, telemonitoring can be widely used as an important part of care for patients and devices. Our objective was to evaluate the benefits of continuous remote monitoring using the BIOTRONIK Home Monitoring® (HM) system compared to standard outpatient follow-ups. 198 patients with single- or dual-chamber implantable cardioverter-defibrillator (ICD) implanted for primary or secondary prevention of sudden cardiac death were randomized into a group of patients followed through standard outpatient visits ( HM-) and a group telemonitored by the HM system (HM+). Planned and emergency visits, ICD-related hospitalizations, and delivered shocks and their appropriateness were evaluated in the respective groups. A significant reduction was achieved in the number of planned (by 48%, p<0.001) and total visits (by 45%, p<0.001) during a three-year evaluation. A comparable number of patients experienced one or more shocks. Mortality rates were equivalent, as was the number of patients hospitalized in relation to their ICD. However, there was a significant reduction in the number and proportion of inappropriate shocks delivered in the HM+ patient group: by 80% (p=0.002) in outpatient follow-up care and by 90% (p<0.001) when multiple shocks requiring hospitalization were included. The HM system was an effective and safe method of follow-up in patients with an implanted ICD. Remote monitoring reduces the number of outpatient visits and inappropriate shocks.

Malfunction of subpectorally implanted cardiac resynchronization therapy defibrillators due to weakened header bond.

PubMed

Hayat, Sajad A; Kojodjojo, Pipin; Mason, Anthony; Benfield, Ann; Wright, Ian; Whinnett, Zachary; Lim, Phang Boon; Davies, D Wyn; Lefroy, David; Peters, Nicholas S; Kanagaratnam, Prapa

2013-03-01

Implantable cardioverter defibrillator (ICD) implantation has increased significantly over the last 10 years. Concerns about the safety and reliability of ICD systems have been raised, with premature lead failure and battery malfunctions accounting for the majority of reported adverse events. We describe the unique mode of presentation, diagnosis, and management of cardiac resynchronization therapy defibrillators (CRT-D) malfunctions that were caused by weakened bonding between the generator and header. Between June 2008 and December 2009, 22 Teligen™ ICDs and 24 Cognis™ CRT-Ds were implanted subpectorally at our institution, until a product advisory was issued. Of 24 Cognis™ CRT-D implants, 3 patients presented with CRT-D malfunctions. All our cases presented with initially intermittent and then persisting increases in shock lead impedance, associated with nonphysiological noise in the shock electrogram channels. These issues were rectified by generator change. Postexplant laboratory analysis confirmed inadequate bonding between device header and titanium casing in all cases, resulting in loosening and rocking of the header followed by fatigue-induced fracture of the shock circuitry. Weakened bonding between the header and generator casing of subpectorally implanted CRT-Ds can result in fractures and malfunction of the HV circuit. Physicians monitoring patients with devices affected by the product advisory should remain vigilant in order to diagnose and manage similar device malfunction expediently. © 2012 Wiley Periodicals, Inc.

Cost-effectiveness of the implantable cardioverter defibrillator: a review of current evidence.

PubMed

Lynd, Larry D; O'Brien, Bernie J

2003-09-01

Implantable cardioverter defibrillator (ICD) therapy is indicated for patients at risk for sudden cardiac death (SCD) due to ventricular tachycardia (VT) or ventricular fibrillation (VF). The high relative cost of therapy with the ICD versus antiarrhythmic drugs has raised questions regarding its cost-effectiveness. To address these questions, we review the literature on ICD cost-effectiveness. MEDLINE and other databases were searched for articles published since 1980 reporting original data on the cost-effectiveness of ICD versus drug therapy for patients at risk for SCD. Data on costs and life-years were abstracted and studies grouped into decision analysis models and trial-based analyses. Cost-effectiveness ratios were inflated to 2002 US dollars. Thirteen economic studies were included in this review: 6 decision-analytic models, 4 economic analysis alongside randomized controlled trials, and 1 observational study. Two additional studies evaluated the cost-effectiveness of ICDs stratified by mortality risk. Studies varied in time horizon, and in all but one study ICD therapy was more costly than drug therapy. Early models assumed larger survival benefits than were observed in subsequent trials; therefore, ICDs appeared to be more cost-effective (i.e., US dollars 28000-US dollars 60000 per life-year gained). Three large clinical trial-based studies estimated that the cost per life-year gained was between US dollars 30181 and US dollars 185000. Stratified analyses show that patients at higher risk for mortality due to structural heart disease (e.g., left ventricular ejection fraction <35%) benefit more from ICD therapy, resulting in lower cost-effectiveness ratios. ICD therapy continues to evolve with changing methods of implantation and improving technology. Current evidence suggests that ICDs may be a cost-effective option in patients at high risk for VT/VF. The cost-effectiveness of ICD therapy for primary and secondary prevention of SCD depends upon patient

Feasibility of heart sounds measurements from an accelerometer within an ICD pulse generator.

PubMed

Siejko, Krzysztof Z; Thakur, Pramodsingh H; Maile, Keith; Patangay, Abhilash; Olivari, Maria-Teresa

2013-03-01

The feasibility of detecting heart sounds (HS) from an accelerometer sensor enclosed within an implantable cardioverter defibrillator (ICD) pulse generator (PG) was explored in a noninvasive pilot study on heart failure (HF) patients with audible third HS (S3). Accelerometer circuitry enhanced for HS was incorporated into non-functional ICDs. A study was conducted on 30 HF patients and 10 normal subjects without history of cardiac disease. The devices were taped to the skin surface over both left and right pectoral regions to simulate subcutaneous implants. A lightweight reference accelerometer was taped over the cardiac apex. Waveforms were recorded simultaneously with a surface electrocardiogram for 2 minutes. Algorithms were developed to perform off-line automatic detection of HS and HS time intervals (HSTIs). S1, S2, and S3 vibrations were detected in all accelerometer locations for all 40 subjects, including 16 subjects without an audible S3. A substantial proportion of S3 energy was infrasonic (<20 Hz). Extending the signal bandwidth accordingly increased HS amplitudes and the ability of S3 to separate HF patients from the normal subgroup. HSTIs also separated the subgroups and were less susceptible to patient-dependent acoustic propagation properties than amplitude measures. HS, including S3 amplitude and HSTIs, may be measured using PG-embedded circuitry at implant sites without special purpose leads. Further study is warranted to determine if relative changes in heart sounds measurements can be effective in applications such as remote ambulatory monitoring of HF progression and the detection of the onset of HF decompensation. ©2012, The Authors. Journal compilation ©2012 Wiley Periodicals, Inc.

Echocardiography and cardiac MRI in mutation-negative hypertrophic cardiomyopathy in an older patient: a case defining the need for ICD.

PubMed

Rodriguez, Fatima; Degnan, Kathleen O; Seidman, Christine E; Mangion, Judy R

2014-08-01

We report the case of a 67-year-old man with hypertrophic cardiomyopathy who presented for a second opinion about implantable cardio-defibrillator (ICD) placement after a witnessed syncopal episode. Despite his older age, being mutation-negative, and having a maximal septal thickness of 2.2 cm on echocardiography, he demonstrated rapid progression of myocardial fibrosis on cardiac MRI, correlating to ventricular tachyarrhythmias and syncope. We review the role of echocardiography and cardiac MRI in optimizing medical care for such patients who may not otherwise meet criteria for an ICD placement or further interventions. © 2014, Wiley Periodicals, Inc.

Performing magnetic resonance imaging in patients with implantable pacemakers and defibrillators: results of a European Heart Rhythm Association survey.

PubMed

Marinskis, Germanas; Bongiorni, Maria Grazia; Dagres, Nikolaos; Dobreanu, Dan; Lewalter, Thorsten; Blomström-Lundqvist, Carina

2012-12-01

The purpose of our survey was to evaluate the experience, current practice and attitudes of performing magnetic resonance imaging (MRI) studies in patients with cardiac implantable electronic devices. Fifty-one centre-members of European Heart Rhythm Association Research network have responded to the survey. According to the obtained data, 55.2% of responding centres do not perform MRI scans in patients with non-MRI-certified pacemakers and 65.8% in patients with such implantable cardioverter defibrillators (ICDs). Reported complication rate in patients with non-MRI-certified devices is low and conforms to the literature data. Experience with newer MRI-compatible pacemakers and ICDs is limited to single cases in most centres. This survey shows limited experience with performing MRI studies in patients with implanted pacemakers and ICDs. In concordance with available guidelines, most centres limit MRI scans in patients with non-MRI-certified devices. The implant numbers for MRI-certified devices and experience with performing MRI scans in these patients are still low.

Effectiveness of implantable cardioverter-defibrillators in survivors of inhospital cardiac arrest.

PubMed

Chan, Paul S; Krumholz, Harlan M; Spertus, John A; Curtis, Lesley H; Li, Yan; Hammill, Bradley G; Nallamothu, Brahmajee K

2015-06-01

Although implantable cardioverter-defibrillators (ICDs) reduce mortality in patients with out-of-hospital cardiac arrest, their effectiveness in survivors of "inhospital" cardiac arrest-a population with different arrest etiologies and higher illness acuity than out-of-hospital cardiac arrest-is unknown. We therefore sought to conduct a comparative effectiveness study of ICD therapy in survivors of inhospital cardiac arrest. We linked data from a national inpatient cardiac arrest registry with Medicare files and identified 1,200 adults from 267 hospitals between 2000 and 2008 who were discharged after surviving an inhospital cardiac arrest due to ventricular fibrillation or pulseless ventricular tachycardia and who otherwise met traditional inclusion and exclusion criteria for secondary prevention ICD trials. The association between ICD treatment and long-term mortality was evaluated using an optimal match (≤4 controls for each ICD patient) propensity-score analysis. Of 1,200 survivors, 343 (28.6%) received an ICD during the index hospitalization. Overall, 3-year mortality was 44.2%, with higher unadjusted mortality in the non-ICD versus the ICD group (46.9% vs 37.3%; log-rank; P < .001). After successfully matching 343 patients treated with ICDs with 823 untreated patients by propensity score, ICD treatment was associated with a 24% lower mortality rate (adjusted hazard ratio [HR] 0.76; 95% CI 0.60-0.97; P = .025). This lower mortality was mediated by lower rates of out-of-hospital deaths among ICD-treated patients (22.1% vs 30.8%; adjusted HR 0.71 [0.52-0.96]; P = .019), whereas deaths occurring during a readmission were similar (15.2% vs 16.1%; adjusted HR 0.89 [95% CI 0.60-1.32]; P = .56). Implantable cardioverter-defibrillator therapy in survivors of inhospital cardiac arrest due to a pulseless ventricular rhythm is used uncommonly but associated with lower long-term mortality. Given that fewer than 3 in 10 eligible survivors are treated with ICDs after

Clinical efficacy and safety of an implantable cardioverter-defibrillator lead with a floating atrial sensing dipole.

PubMed

Safak, Erdal; Schmitz, Dietmar; Konorza, Thomas; Wende, Christian; De Ros, Jose Olague; Schirdewan, Alexander

2013-08-01

The concept of a single-lead implantable cardioverter-defibrillator (ICD), with a floating dipole, has been proven safe and functional. The studied active-fixation, steroid-eluting lead (Linox(smart) S DX, BIOTRONIK SE & Co KG, Berlin, Germany) is one French thinner than its predecessor and coated with lubricious SilGlide to improve lead handling. A dedicated ICD device has a self-adaptive atrial input stage including a fourfold amplifier. The amplification, filtering, and adapted atrial input stage are located in the Lumax 540 VR-T DX (BIOTRONIK). The Linox(smart) S DX ICD lead delivers only the signal. The lead was evaluated during implantation; at predischarge; and 1-, 3-, and 6-month follow-up examinations. The primary endpoint (efficacy) was the rate of appropriate atrial sensing tests. The secondary endpoint (safety) was freedom from lead-related invasive reinterventions. Both safety and efficacy were expected to be significantly higher than 90%. The study enrolled 116 patients at 25 clinical sites. Skin-to-skin operation time was 52.4 ± 26.2 minutes. The investigators graded lead insertion as "easy" in 87% of patients. Mean P-wave amplitudes (preamplified) varied from 5.0 to 6.1 mV in different body positions. Both primary and secondary endpoints were met, as 93.8% (364/388; P = 0.005) of specific sensing tests indicated appropriate atrial sensing, and 94.8% (110/116; P = 0.048) of patients were free from reinterventions (lead dislodgement). Analysis of arrhythmia episodes stored in ICDs and elective 24-hour Holter electrocardiogram tests raised no concerns about lead functionality. The studied ICD lead with a floating atrial sensing dipole met the predefined safety expectation and demonstrated appropriate atrial sensing performance. ©2013, The Authors. Journal compilation ©2013 Wiley Periodicals, Inc.

Radiotherapy and risk of implantable cardioverter-defibrillator malfunctions: experimental data from direct exposure at increasing doses.

PubMed

Zecchin, Massimo; Artico, Jessica; Morea, Gaetano; Severgnini, Mara; Bianco, Elisabetta; De Luca, Antonio; Fantasia, Anna Zorzin; Salvatore, Luca; Milan, Vittorino; Lucarelli, Matteo; Dissegna, Roberta; Cannatà, Antonio; Sinagra, Gianfranco

2018-04-01

During radiotherapy, in patients with implantable cardioverter-defibrillators (ICDs) malfunctions are considered more likely if doses more than 2 Gy reach the ICD site; however, most malfunctions occur with high-energy (>10 MV) radiations, and the risk is less defined using 6-MV linear accelerators. The purpose of the study is to experimentally evaluate the occurrence of malfunctions in ICDs radiated with a 6-MV linear accelerator at increasing photon doses. Thirty-two ICDs from all manufacturers (31 explanted and one demo) were evaluated; all devices with a sufficient battery charge underwent multiple radiations with a 6-MV photon beam reaching a cumulative dose at ICD site of 0.5, 1, 2, 3, 5 and 10 Gy and interrogated after every session. All antitachycardia therapies were left enabled; two ICDs were connected to a rhythm simulator (one simulating a complete atrioventricular block without ventricular activity) and visually monitored by external ECG and the ICD programmer during radiation. Thirteen ICDs were excluded before radiation because of battery depletion; after radiation up to the cumulative dose at the cardiac implantable electronic device site of 10 Gy, in the remaining 19 devices, programmation and battery charge remained unchanged and no switch to safety mode was observed; oversensing, pacing inhibition or inappropriate antitachycardia therapy were neither recorded nor visually observed during radiation. With a low-energy accelerator, neither malfunctions nor electromagnetic interferences were detected radiating the ICDs at doses usually reaching the ICD pocket during radiotherapy sessions. In this context, magnet application to avoid oversensing and inappropriate therapy seems, therefore, useless.

Utilization of YouTube as a Tool to Assess Patient Perception Regarding Implanted Cardiac Devices.

PubMed

Hayes, Kevin; Mainali, Prajeena; Deshmukh, Abhishek; Pant, Sadip; Badheka, Apurva O; Paydak, Hakan

2014-07-01

The outreach of YouTube may have a dramatic role in the widespread dissemination of knowledge on implantable cardioverter devices (ICD). This study was designed to review and analyze the information available on YouTube pertaining to implantable cardiac devices such as implantable cardioverter defibrillators (ICDs) and pacemakers. YouTube was queried for the terms "ICD", "Implantable Cardioverter Defibrillator", and "Pacemaker". The videos were reviewed and categorized as according to content; number of views and "likes" or "dislikes" was recorded by two separate observers. Of the 55 videos reviewed, 18 of the videos were categorized as patient education, 12 were advertisements, 8 were intraoperative videos documenting the device implantation procedures, 7 of the videos were produced to document personal patient experiences, and 4 were categorized as documentation of a public event. 3 were intended to educate health care workers. The remaining 3 were intended to raise public awareness about sudden cardiac death. The videos portraying intraoperative procedures generated the most "likes" or "dislikes" per view. While YouTube provides a logical platform for delivery of health information, the information on this platform is not regulated. Initiative by reputed authorities and posting accurate information in such platform can be a great aid in public education regarding device therapy.

Characteristics of ventricular fibrillation in relation to cardiac aetiology and shock success: A waveform analysis study in ICD-patients.

PubMed

Bonnes, Judith L; Keuper, Wessel; Westra, Sjoerd W; Zegers, Erwin S; Oostendorp, Thom F; Brouwer, Marc A; Smeets, Joep L R M

2015-01-01

Ventricular fibrillation (VF) waveform characteristics are associated with cardiac arrest duration and defibrillation success. Recent animal studies found that VF characteristics and shock success also depend on the presence of myocardial infarction (MI). In patients, VF induction after implantable cardioverter defibrillator (ICD) implantation offers a unique setting to study early VF characteristics: we studied the relation with cardiac disease--either presence or absence of a previous MI--and with shock success. Retrospective cohort study of ICD-patients who underwent defibrillation testing, 117 (63%) with and 69 (37%) without a previous MI. Intracardiac recordings of induced VF were analysed using Fourier analysis. In previous MI-patients, the fundamental frequency and organisation index of the VF signal were significantly lower as compared with patients without a previous MI: 4.9 Hz ± 0.6 vs. 5.2 Hz ± 0.6 (p = 0.005) and 56% ± 10 vs. 60% ± 9 (p = 0.001), respectively. The median frequency was not different (p = 0.25). We found no association between VF characteristics and ICD shock success. In analogy with observations in animals, we found that a history of a previous MI was associated with slower and less organised VF. In our cohort of ICD-patients, early VF waveform characteristics were not associated with shock outcomes. Further study is warranted to determine to what extent VF characteristics are influenced by the underlying aetiology on the one hand, and time delay on the other. These findings could improve insight into the potential value of VF analysis to guide shock delivery. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Efficacy and safety of celivarone, with amiodarone as calibrator, in patients with an implantable cardioverter-defibrillator for prevention of implantable cardioverter-defibrillator interventions or death: the ALPHEE study.

PubMed

Kowey, Peter R; Crijns, Harry J G M; Aliot, Etienne M; Capucci, Alessandro; Kulakowski, Piotr; Radzik, David; Roy, Denis; Connolly, Stuart J; Hohnloser, Stefan H

2011-12-13

Celivarone is a new antiarrhythmic agent developed for the treatment of ventricular arrhythmias. This study investigated the efficacy and safety of celivarone in preventing implantable cardioverter-defibrillator (ICD) interventions or death. Celivarone (50, 100, or 300 mg/d) was assessed compared with placebo in this randomized, double-blind, placebo-controlled, parallel-group study. Amiodarone (200 mg/d after loading dose of 600 mg/d for 10 days) was used as a calibrator. A total of 486 patients with a left ventricular ejection fraction ≤40% and at least 1 ICD intervention for ventricular tachycardia or ventricular fibrillation in the previous month or ICD implantation in the previous month for documented ventricular tachycardia/ventricular fibrillation were randomized. Median treatment duration was 9 months. The primary efficacy end point was occurrence of ventricular tachycardia/ventricular fibrillation-triggered ICD interventions (shocks or antitachycardia pacing) or sudden death. The proportion of patients experiencing an appropriate ICD intervention or sudden death was 61.5% in the placebo group; 67.0%, 58.8%, and 54.9% in the celivarone 50-, 100-, and 300-mg groups, respectively; and 45.3% in the amiodarone group. Hazard ratios versus placebo for the primary end point ranged from 0.860 for celivarone 300 mg to 1.199 for celivarone 50 mg. None of the comparisons versus placebo were statistically significant. Celivarone had an acceptable safety profile. Celivarone was not effective for the prevention of ICD interventions or sudden death. http://www.clinicaltrials.gov. Unique identifier: NCT00993382.

Performance of re-used pacemakers and implantable cardioverter defibrillators compared with new devices at Groote Schuur Hospital in Cape Town, South Africa

PubMed Central

Jama, Zimasa V; Chin, Ashley; Mayosi, Bongani M; Badri, Motasim

2015-01-01

Objectives Little is known about the performance of re-used pacemakers and implantable cardioverter defibrillators (ICDs) in Africa. We sought to compare the risk of infection and the rate of malfunction of re-used pacemakers and ICDs with new devices implanted at Groote Schuur Hospital in Cape Town, South Africa. Methods This was a retrospective case comparison study of the performance of re-used pacemakers and ICDs in comparison with new devices implanted at Groote Schuur Hospital over a 10-year period. The outcomes were incidence of device infection, device malfunction, early battery depletion, and device removal due to infection, malfunction, or early battery depletion. Results Data for 126 devices implanted in 126 patients between 2003 and 2013 were analysed, of which 102 (81%) were pacemakers (51 re-used and 51 new) and 24 (19%) were ICDs (12 re-used and 12 new). There was no device infection, malfunction, early battery depletion or device removal in either the re-used or new pacemaker groups over the median follow up of 15.1 months [interquartile range (IQR), 1.3–36.24 months] for the re-used pacemakers, and 55.8 months (IQR, 20.3–77.8 months) for the new pacemakers. In the ICD group, no device infection occurred over a median follow up of 35.9 months (IQR, 17.0–70.9 months) for the re-used ICDs and 45.7 months (IQR, 37.6–53.7 months) for the new ICDs. One device delivered inappropriate shocks, which resolved without intervention and with no harm to the patient. This re-used ICD subsequently needed generator replacement 14 months later. In both the pacemaker and ICD groups, there were no procedure-non-related infections documented for the respective follow-up periods. Conclusion No significant differences were found in performance between re-used and new pacemakers and ICDs with regard to infection rates, device malfunction, battery life and device removal for complications. Pacemaker and ICD re-use is feasible and safe and is a viable option for

Improved survival in patients enrolled promptly into remote monitoring following cardiac implantable electronic device implantation.

PubMed

Mittal, Suneet; Piccini, Jonathan P; Snell, Jeff; Prillinger, Julie B; Dalal, Nirav; Varma, Niraj

2016-08-01

Guidelines advocate remote monitoring (RM) in patients with a cardiac implantable electronic device (CIED). However, it is not known when RM should be initiated. We hypothesized that prompt initiation of RM (within 91 days of implant) is associated with improved survival compared to delayed initiation. This retrospective, national, observational cohort study evaluated patients receiving new implants of market-released St. Jude Medical™ pacemakers (PM), implantable cardioverter defibrillators (ICD), and cardiac resynchronization therapy (CRT) devices. Patients were assigned to one of two groups: an "RM Prompt" group, in which RM was initiated within 91 days of implant; and an "RM Delayed" group, in which RM was initiated >91 days but ≤365 days of implant. The primary endpoint was all-cause mortality. The cohort included 106,027 patients followed for a mean of 2.6 ± 0.9 years. Overall, 47,014 (44 %) patients had a PM, 31,889 (30 %) patients had an ICD, 24,005 (23 %) patients had a CRT-D, and 3119 (3 %) patients had a CRT-P. Remote monitoring was initiated promptly (median 4 weeks [IQR 2, 8 weeks]) in 66,070 (62 %) patients; in the other 39,957 (38 %) patients, RM initiation was delayed (median 24 weeks [IQR 18, 34 weeks]). In comparison to delayed initiation, prompt initiation of RM was associated with a lower mortality rate (4023 vs. 4679 per 100,000 patient-years, p < 0.001) and greater adjusted survival (HR 1.18 [95 % CI 1.13-1.22], p < 0.001). Our data, for the first time, show improved survival in patients enrolled promptly into RM following CIED implantation. This advantage was observed across all CIED device types.

Increased confidence to engage in physical exertion: older ICD recipients' experiences of participating in an exercise training programme.

PubMed

Morken, Ingvild Margreta; Norekvål, Tone M; Isaksen, Kjetil; Munk, Peter S; Karlsen, Bjørg; Larsen, Alf I

2013-06-01

Research suggests that exercise training (ET) programmes may improve both physical and psychosocial functioning in implantable cardioverter defibrillator (ICD) recipients. Most of this research has been conducted by means of quantitative methods. However, knowledge of older ICD recipients' experiences of participating in such programmes is sparse. There is thus a need for more detailed qualitative data from the perspective of older patients. To describe older ICD recipients' experiences of participating in an ET programme. A qualitative design with semistructured interviews involving 12 older ICD recipients who had participated in a 3-month ET programme. Mini-disc recordings of the interviews were transcribed verbatim and analysed using content analysis. The analysis revealed two major themes: (1) 'increased confidence to engage in physical exertion'; and (2) 'increased satisfaction with life'. The first theme is illustrated by three subthemes: 'perceived support from physiotherapists', 'perceiving the heart rate monitor as a motivation to exercise', and 'perceiving peers as motivators for enjoyment and making the effort to exercise'. The second theme was illustrated by the following subthemes: 'perceived psychosocial benefits', 'perceived physical benefits', and 'exercise as a new health habit'. The findings indicate that exercising in a cardiac rehabilitation centre together with peers and supervised by skilled healthcare professionals may increase motivation to exert oneself, leading to emotional and physical benefits as well as a more social and active lifestyle for older ICD recipients.

Clinical implications of the proposed ICD-11 PTSD diagnostic criteria.

PubMed

Barbano, Anna C; van der Mei, Willem F; Bryant, Richard A; Delahanty, Douglas L; deRoon-Cassini, Terri A; Matsuoka, Yutaka J; Olff, Miranda; Qi, Wei; Ratanatharathorn, Andrew; Schnyder, Ulrich; Seedat, Soraya; Kessler, Ronald C; Koenen, Karestan C; Shalev, Arieh Y

2018-05-14

Projected changes to post-traumatic stress disorder (PTSD) diagnostic criteria in the upcoming International Classification of Diseases (ICD)-11 may affect the prevalence and severity of identified cases. This study examined differences in rates, severity, and overlap of diagnoses using ICD-10 and ICD-11 PTSD diagnostic criteria during consecutive assessments of recent survivors of traumatic events. The study sample comprised 3863 survivors of traumatic events, evaluated in 11 longitudinal studies of PTSD. ICD-10 and ICD-11 diagnostic rules were applied to the Clinician-Administered PTSD Scale (CAPS) to derive ICD-10 and ICD-11 diagnoses at different time intervals between trauma occurrence and 15 months. The ICD-11 criteria identified fewer cases than the ICD-10 across assessment intervals (range -47.09% to -57.14%). Over 97% of ICD-11 PTSD cases met concurrent ICD-10 PTSD criteria. PTSD symptom severity of individuals identified by the ICD-11 criteria (CAPS total scores) was 31.38-36.49% higher than those identified by ICD-10 criteria alone. The latter, however, had CAPS scores indicative of moderate PTSD. ICD-11 was associated with similar or higher rates of comorbid mood and anxiety disorders. Individuals identified by either ICD-10 or ICD-11 shortly after traumatic events had similar longitudinal course. This study indicates that significantly fewer individuals would be diagnosed with PTSD using the proposed ICD-11 criteria. Though ICD-11 criteria identify more severe cases, those meeting ICD-10 but not ICD-11 criteria remain in the moderate range of PTSD symptoms. Use of ICD-11 criteria will have critical implications for case identification in clinical practice, national reporting, and research.

Leveraging the NLM map from SNOMED CT to ICD-10-CM to facilitate adoption of ICD-10-CM.

PubMed

Cartagena, F Phil; Schaeffer, Molly; Rifai, Dorothy; Doroshenko, Victoria; Goldberg, Howard S

2015-05-01

Develop and test web services to retrieve and identify the most precise ICD-10-CM code(s) for a given clinical encounter. Facilitate creation of user interfaces that 1) provide an initial shortlist of candidate codes, ideally visible on a single screen; and 2) enable code refinement. To satisfy our high-level use cases, the analysis and design process involved reviewing available maps and crosswalks, designing the rule adjudication framework, determining necessary metadata, retrieving related codes, and iteratively improving the code refinement algorithm. The Partners ICD-10-CM Search and Mapping Services (PI-10 Services) are SOAP web services written using Microsoft's.NET 4.0 Framework, Windows Communications Framework, and SQL Server 2012. The services cover 96% of the Partners problem list subset of SNOMED CT codes that map to ICD-10-CM codes and can return up to 76% of the 69,823 billable ICD-10-CM codes prior to creation of custom mapping rules. We consider ways to increase 1) the coverage ratio of the Partners problem list subset of SNOMED CT codes and 2) the upper bound of returnable ICD-10-CM codes by creating custom mapping rules. Future work will investigate the utility of the transitive closure of SNOMED CT codes and other methods to assist in custom rule creation and, ultimately, to provide more complete coverage of ICD-10-CM codes. ICD-10-CM will be easier for clinicians to manage if applications display short lists of candidate codes from which clinicians can subsequently select a code for further refinement. The PI-10 Services support ICD-10 migration by implementing this paradigm and enabling users to consistently and accurately find the best ICD-10-CM code(s) without translation from ICD-9-CM. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

T wave alternans as a predictor of recurrent ventricular tachyarrhythmias in ICD recipients: prospective comparison with conventional risk markers

NASA Technical Reports Server (NTRS)

Hohnloser, S. H.; Klingenheben, T.; Li, Y. G.; Zabel, M.; Peetermans, J.; Cohen, R. J.

1998-01-01

INTRODUCTION: The current standard for arrhythmic risk stratification is electrophysiologic (EP) testing, which, due to its invasive nature, is limited to patients already known to be at high risk. A number of noninvasive tests, such as determination of left ventricular ejection fraction (LVEF) or heart rate variability, have been evaluated as additional risk stratifiers. Microvolt T wave alternans (TWA) is a promising new risk marker. Prospective evaluation of noninvasive risk markers in low- or moderate-risk populations requires studies involving very large numbers of patients, and in such studies, documentation of the occurrence of ventricular tachyarrhythmias is difficult. In the present study, we identified a high-risk population, recipients of an implantable cardioverter defibrillator (ICD), and prospectively compared microvolt TWA with invasive EP testing and other risk markers with respect to their ability to predict recurrence of ventricular tachyarrhythmias as documented by ICD electrograms. METHODS AND RESULTS: Ninety-five patients with a history of ventricular tachyarrhythmias undergoing implantation of an ICD underwent EP testing, assessment of TWA, as well as determination of LVEF, baroreflex sensitivity, signal-averaged ECG, analysis of 24-hour Holter monitoring, and QT dispersion from the 12-lead surface ECG. The endpoint of the study was first appropriate ICD therapy for electrogram-documented ventricular fibrillation or tachycardia during follow-up. Kaplan-Meier survival analysis revealed that TWA (P < 0.006) and LVEF (P < 0.04) were the only significant univariate risk stratifiers. EP testing was not statistically significant (P < 0.2). Multivariate Cox regression analysis revealed that TWA was the only statistically significant independent risk factor. CONCLUSIONS: Measurement of microvolt TWA compared favorably with both invasive EP testing and other currently used noninvasive risk assessment methods in predicting recurrence of ventricular

Implantable Cardioverter Defibrillators. Prophylactic Use

PubMed Central

2005-01-01

Executive Summary Objective The use of implantable cardiac defibrillators (ICDs) to prevent sudden cardiac death (SCD) in patients resuscitated from cardiac arrest or documented dangerous ventricular arrhythmias (secondary prevention of SCD) is an insured service. In 2003 (before the establishment of the Ontario Health Technology Advisory Committee), the Medical Advisory Secretariat conducted a health technology policy assessment on the prophylactic use (primary prevention of SCD) of ICDs for patients at high risk of SCD. The Medical Advisory Secretariat concluded that ICDs are effective for the primary prevention of SCD. Moreover, it found that a more clearly defined target population at risk for SCD that would be likely to benefit from ICDs is needed, given that the number needed to treat (NNT) from recent studies is 13 to 18, and given that the per-unit cost of ICDs is $32,000, which means that the projected cost to Ontario is $770 million (Cdn). Accordingly, as part of an annual review and publication of more recent articles, the Medical Advisory Secretariat updated its health technology policy assessment of ICDs. Clinical Need Sudden cardiac death is caused by the sudden onset of fatal arrhythmias, or abnormal heart rhythms: ventricular tachycardia (VT), a rhythm abnormality in which the ventricles cause the heart to beat too fast, and ventricular fibrillation (VF), an abnormal, rapid and erratic heart rhythm. About 80% of fatal arrhythmias are associated with ischemic heart disease, which is caused by insufficient blood flow to the heart. Management of VT and VF with antiarrhythmic drugs is not very effective; for this reason, nonpharmacological treatments have been explored. One such treatment is the ICD. The Technology An ICD is a battery-powered device that, once implanted, monitors heart rhythm and can deliver an electric shock to restore normal rhythm when potentially fatal arrhythmias are detected. The use of ICDs to prevent SCD in patients resuscitated

Inappropriate Implantable Cardioverter-Defibrillator Shock from QRS Double Counting in the Setting of Hyperkalemia.

PubMed

Dadlani, Akash; Dukes, Jonathan W; Badhwar, Nitish

2016-03-01

This case shows the complexity of arrhythmia management in patients with implantable cardioverter-defibrillators (ICDs) who present with hyperkalemia. In order to prevent inappropriate ICD shock, consideration should be given to the suspension of ICD therapies while intensive care treatment of extreme electrolyte derangements is being pursued. Patients in these setting should be closely monitored until their electrocardiograms have normalized, after which the device can safely be reactivated. Copyright © 2016 Elsevier Inc. All rights reserved.

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

PubMed Central

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

2013-01-01

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

Neurodevelopmental Disorders (ASD and ADHD): DSM-5, ICD-10, and ICD-11.

PubMed

Doernberg, Ellen; Hollander, Eric

2016-08-01

Neurodevelopmental disorders, specifically autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD) have undergone considerable diagnostic evolution in the past decade. In the United States, the current system in place is the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), whereas worldwide, the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) serves as a general medical system. This review will examine the differences in neurodevelopmental disorders between these two systems. First, we will review the important revisions made from the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) to the DSM-5, with respect to ASD and ADHD. Next, we will cover the similarities and differences between ASD and ADHD classification in the DSM-5 and the ICD-10, and how these differences may have an effect on neurodevelopmental disorder diagnostics and classification. By examining the changes made for the DSM-5 in 2013, and critiquing the current ICD-10 system, we can help to anticipate and advise on the upcoming ICD-11, due to come online in 2017. Overall, this review serves to highlight the importance of progress towards complementary diagnostic classification systems, keeping in mind the difference in tradition and purpose of the DSM and the ICD, and that these systems are dynamic and changing as more is learned about neurodevelopmental disorders and their underlying etiology. Finally this review will discuss alternative diagnostic approaches, such as the Research Domain Criteria (RDoC) initiative, which links symptom domains to underlying biological and neurological mechanisms. The incorporation of new diagnostic directions could have a great effect on treatment development and insurance coverage for neurodevelopmental disorders worldwide.

Association between Serum Uric Acid Level and Ventricular Tachyarrhythmia in Heart Failure Patients with Implantable Cardioverter-Defibrillator.

PubMed

Nodera, Minoru; Suzuki, Hitoshi; Matsumoto, Yoshiyuki; Kamioka, Masashi; Kaneshiro, Takashi; Yoshihisa, Akiomi; Ohira, Tetsuya; Takeishi, Yasuchika

2018-05-25

The uric acid (UA) level is related to cardiac events and mortality, but little is known about the clinical significance of serum UA with regard to the ventricular tachyarrhythmia (VT) risk in patients with heart failure. The present study enrolled 56 patients with ischemic and nonischemic cardiomyopathy (37 males, mean age 64.7 ± 11.1 years) who received prophylactic implantable cardioverter-defibrillator (ICD) implantation. Based on a median serum UA value, study subjects were divided into two groups: serum UA < 6.1 mg/dL (group L, n = 29) and ≥6.1 mg/dL (group H, n = 27). Echo- and electrocardiograms (QRS duration and QTc intervals) were examined in each group. During the follow-up period (30 ± 8 months), 22 (39%) patients had appropriate ICD therapies for sustained VT. There was no significant difference in the electro- and echocardiographic data between both groups. However, appropriate ICD therapies were significantly higher in group H than in group L (p  =  0.02). In multivariate analysis, UA was an independent predictor of appropriate ICD therapies (hazard ratio 1.826, 95% confidence interval 1.248-2.671, p = 0.002). Serum UA levels might be a predictor of VT, providing new aspects regarding the decision to adapt ICD implantation in patients with heart failure. © 2018 S. Karger AG, Basel.

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.

Eligibility and utilization of implantable cardioverter-defibrillators in a regional STEMI system.

PubMed

Johnson, Benjamin K; Garberich, Ross F; Henry, Timothy D; Katsiyiannis, William T; Sengupta, Jay; Kalra, Ankur; Hauser, Robert G; Lardy, Meghan E; Newell, Marc C

2016-02-01

Studies have shown mortality benefit for implantable cardioverter-defibrillators (ICDs) in ST-elevation myocardial infarction (STEMI) patients with reduced left ventricular ejection fraction (LVEF), but contemporary eligibility and appropriate utilization of ICDs is unknown. The purpose of this study was to determine the contemporary eligibility and appropriate utilization of ICDs post-STEMI. Using the prospective Minneapolis Heart Institute regional STEMI registry, LVEF before discharge and at follow-up were stratified into 3 groups: normal (LVEF ≥50%), mildly reduced (LVEF 35%-49%), and severely reduced (LVEF <35%). From March 2003 to June 2012, 3626 patients were treated. Patients with in-hospital death (n = 187), ICD in place (n = 21), negative cardiac biomarkers (n = 337), and undocumented in-hospital LVEF (n = 9) were excluded, leaving 3072 patients in the final analysis, including 1833 (59.7%) with LVEF ≥50%, 875 (28.5%) with LVEF between 35% and 49%, and 364 (11.8%) with LVEF <35% before hospital discharge. Overall, 1029 patients (33.5%) underwent follow-up echocardiography ≥40 days post-STEMI, including 140 of the 364 patients (38.5%) discharged with LVEF <35%. In total, 73 patients (7.1%) with follow-up echocardiography ≥40 days post-STEMI met criteria for an ICD (68 LVEF ≤30%, 5 LVEF 30%-35%, and New York Heart Association class II or greater). Only 26 of these patients (35.6%) underwent ICD placement within 1 year post-STEMI. Overall, only 10% to 15% of potentially eligible patients had an ICD implemented. Rates of ICD implantation in appropriate STEMI patients after 40 days are low. Strategies are needed to identify and expand access to these high-risk patients. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

[Cause-of-death statistics and ICD, quo vadis?

PubMed

Eckert, Olaf; Vogel, Ulrich

2018-07-01

The International Statistical Classification of Diseases and Related Health Problems (ICD) is the worldwide binding standard for generating underlying cause-of-death statistics. What are the effects of former revisions of the ICD on underlying cause-of-death statistics and which opportunities and challenges are becoming apparent in a possible transition process from ICD-10 to ICD-11?This article presents the calculation of the exploitation grade of ICD-9 and ICD-10 in the German cause-of-death statistics and quality of documentation. Approximately 67,000 anonymized German death certificates are processed by Iris/MUSE and official German cause-of-death statistics are analyzed.In addition to substantial changes in the exploitation grade in the transition from ICD-9 to ICD-10, regional effects become visible. The rate of so-called "ill-defined" conditions exceeds 10%.Despite substantial improvement of ICD revisions there are long-known deficits in the coroner's inquest, filling death certificates and quality of coding. To make better use of the ICD as a methodological framework for mortality statistics and health reporting in Germany, the following measures are necessary: 1. General use of Iris/MUSE, 2. Establishing multiple underlying cause-of-death statistics, 3. Introduction of an electronic death certificate, 4. Improvement of the medical assessment of cause of death.Within short time the WHO will release the 11th revision of the ICD that will provide additional opportunities for the development of underlying cause-of-death statistics and their use in science, public health and politics. A coordinated effort including participants in the process and users is necessary to meet the related challenges.

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

PubMed

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

2009-11-24

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

Prospective Randomized Evaluation of Implantable Cardioverter-Defibrillator Programming in Patients With a Left Ventricular Assist Device.

PubMed

Richardson, Travis D; Hale, Leslie; Arteaga, Christopher; Xu, Meng; Keebler, Mary; Schlendorf, Kelly; Danter, Matthew; Shah, Ashish; Lindenfeld, JoAnn; Ellis, Christopher R

2018-02-23

Ventricular arrhythmias are common in patients with left ventricular assist devices (LVADs) but are often hemodynamically tolerated. Optimal implantable cardioverter defibrillator (ICD) tachy-programming strategies in patients with LVAD have not been determined. We sought to determine if an ultra-conservative ICD programming strategy in patients with LVAD affects ICD shocks. Adult patients with an existing ICD undergoing continuous flow LVAD implantation were randomized to standard ICD programming by their treating physician or an ultra-conservative ICD programming strategy utilizing maximal allowable intervals to detection in the ventricular fibrillation and ventricular tachycardia zones with use of ATP. Patients with cardiac resynchronization therapy (CRT) devices were also randomized to CRT ON or OFF. Patients were followed a minimum of 6 months. The primary outcome was time to first ICD shock. Among the 83 patients studied, we found no statistically significant difference in time to first ICD shock or total ICD shocks between groups. In the ultra-conservative group 16% of patients experienced at least one shock compared with 21% in the control group ( P =0.66). There was no difference in mortality, arrhythmic hospitalization, or hospitalization for heart failure. In the 41 patients with CRT ICDs fewer shocks were observed with CRT-ON but this was not statistically significant: 10% of patients with CRT-ON (n=21) versus 38% with CRT-OFF (n=20) received shocks ( P =0.08). An ultra-conservative programming strategy did not reduce ICD shocks. Programming restrictions on ventricular tachycardia and ventricular fibrillation zone therapy should be reconsidered for the LVAD population. The role of CRT in patients with LVAD warrants further investigation. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01977703. © 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

Trajectories of perceived emotional and physical distress in patients with an implantable cardioverter defibrillator.

PubMed

van den Broek, Krista C; Kupper, Nina; van der Voort, Pepijn H; Alings, Marco; Denollet, Johan; Nyklíček, Ivan

2014-02-01

Little is known about the course of emotional and physical distress in patients with an implantable cardioverter defibrillator (ICD). We examined (1) trajectories of emotional and physical distress in the first 18 months postimplantation and (2) predictors of these trajectories, including demographical, clinical, and personality factors. Dutch patients with an ICD (N = 645) completed measures on anxiety, depression, somatic symptoms, and perceived disability at the time of implantation, and 2, 12, and 18 months postimplantation. Measures on Type D personality (tendency to inhibit the expression of negative emotions) and anxiety sensitivity (tendency to fear anxiety-related sensations) were also completed at baseline. Latent class analysis (LatentGOLD) identified six to seven distinct trajectories, varying largely in overall levels of distress, and remaining relatively stable after a small initial decline. Multinomial regression showed that Type D personality and anxiety sensitivity were the most prominent predictors, particularly of trajectories that reflected higher distress levels. Cardiac resynchronization therapy and coronary artery disease also increased the risk for distress, whereas ICD indication and shocks did not. The course of emotional and physical distress may be relatively stable after ICD implantation. In clinical practice, identification of patients with high risk of higher levels of emotional and physical distress may be warranted; as such, patients with high levels of anxiety sensitivity or a Type D personality should be identified and offered behavioral support.

Greater Prevalence of Proposed ICD-11 Alcohol and Cannabis Dependence Compared to ICD-10, DSM-IV, and DSM-5 in Treated Adolescents.

PubMed

Chung, Tammy; Cornelius, Jack; Clark, Duncan; Martin, Christopher

2017-09-01

Proposed International Classification of Diseases, 11th edition (ICD-11), criteria for substance use disorder (SUD) radically simplify the algorithm used to diagnose substance dependence. Major differences in case identification across DSM and ICD impact determinations of treatment need and conceptualizations of substance dependence. This study compared the draft algorithm for ICD-11 SUD against DSM-IV, DSM-5, and ICD-10, for alcohol and cannabis. Adolescents (n = 339, ages 14 to 18) admitted to intensive outpatient addictions treatment completed, as part of a research study, a Structured Clinical Interview for DSM SUDs adapted for use with adolescents and which has been used to assess DSM and ICD SUD diagnoses. Analyses examined prevalence across classification systems, diagnostic concordance, and sources of diagnostic disagreement. Prevalence of any past-year proposed ICD-11 alcohol or cannabis use disorder was significantly lower compared to DSM-IV and DSM-5 (ps < 0.01). However, prevalence of proposed ICD-11 alcohol and cannabis dependence diagnoses was significantly higher compared to DSM-IV, DSM-5, and ICD-10 (ps < 0.01). ICD-11 and DSM-5 SUD diagnoses showed only moderate concordance. For both alcohol and cannabis, youth typically met criteria for an ICD-11 dependence diagnosis by reporting tolerance and much time spent using or recovering from the substance, rather than symptoms indicating impaired control over use. The proposed ICD-11 dependence algorithm appears to "overdiagnose" dependence on alcohol and cannabis relative to DSM-IV and ICD-10 dependence, and DSM-5 moderate/severe use disorder, generating potential "false-positive" cases of dependence. Among youth who met criteria for proposed ICD-11 dependence, few reported impaired control over substance use, highlighting ongoing issues in the conceptualization and diagnosis of SUD. Copyright © 2017 by the Research Society on Alcoholism.

Primary Prevention Implantable Cardioverter-Defibrillators and Survival in Older Women

PubMed Central

Zeitler, Emily P.; Hellkamp, Anne S.; Fonarow, Gregg C.; Hammill, Stephen C.; Curtis, Lesley H.; Hernandez, Adrian F.; Al-Khalidi, Hussein R.; Curtis, Jeptha P.; Heidenreich, Paul A.; Anstrom, Kevin J.; Peterson, Eric D.; Mark, Daniel B.; Hammill, Bradley G.; Sanders, Gillian D.; Al-Khatib, Sana M.

2015-01-01

OBJECTIVES The purpose of this study was to assess the benefit of primary prevention implantable cardioverter defibrillators (ICDs) in women. BACKGROUND Clinical trials of primary prevention ICDs enrolled a limited number of women. METHODS Using a propensity score method, we matched 490 women ≥65 years of age who received an ICD during a hospitalization for heart failure in the National Cardiovascular Data Registry ICD Registry from January 1, 2006, through December 31, 2007, to 490 ICD-eligible women without an ICD hospitalized for heart failure in the Get With The Guidelines for Heart Failure database from January 1, 2006, through December 31, 2009. The primary endpoint was all-cause mortality obtained from the Medicare Claims Database. An identical analysis was conducted in men. RESULTS Median follow-up for patients with an ICD was 4.6 years versus 3.2 years for patients with no ICD. Compared with women with no ICD, those with an ICD were younger and less frequently white. In the matched cohorts, the survival of women with an ICD was significantly longer than that of women without an ICD (adjusted hazard ratio: 0.79, 95% confidence interval: 0.66 to 0.95; p = 0.013). Similarly, men with an ICD had longer survival than men without an ICD (adjusted hazard ratio: 0.73, 95% confidence interval: 0.65 to 0.83; p < 0.0001). There was no interaction between sex and the presence of an ICD with respect to survival (p = 0.44). CONCLUSIONS Among older women with left ventricular dysfunction, a primary prevention ICD was associated with a significant survival benefit that was nearly identical to that seen in men. These findings support the use of primary prevention ICDs in eligible patients regardless of sex. PMID:25543969

Comparison of DSM-5 and proposed ICD-11 criteria for PTSD with DSM-IV and ICD-10: changes in PTSD prevalence in military personnel.

PubMed

Kuester, Annika; Köhler, Kai; Ehring, Thomas; Knaevelsrud, Christine; Kober, Louisa; Krüger-Gottschalk, Antje; Schäfer, Ingo; Schellong, Julia; Wesemann, Ulrich; Rau, Heinrich

2017-01-01

Background: Recently, changes have been introduced to the diagnostic criteria for posttraumatic stress disorder (PTSD) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM) and the International Classification of Diseases (ICD). Objectives: This study investigated the effect of the diagnostic changes made from DSM-IV to DSM-5 and from ICD-10 to the proposed ICD-11. The concordance of provisional PTSD prevalence between the diagnostic criteria was examined in a convenience sample of 100 members of the German Armed Forces. Method: Based on questionnaire measurements, provisional PTSD prevalence was assessed according to DSM-IV, DSM-5, ICD-10, and proposed ICD-11 criteria. Consistency of the diagnostic status across the diagnostic systems was statistically evaluated. Results: Provisional PTSD prevalence was the same for DSM-IV and DSM-5 (both 56%) and comparable under DSM-5 versus ICD-11 proposal (48%). Agreement between DSM-IV and DSM-5, and between DSM-5 and the proposed ICD-11, was high (both p  < .001). Provisional PTSD prevalence was significantly increased under ICD-11 proposal compared to ICD-10 (30%) which was mainly due to the deletion of the time criterion. Agreement between ICD-10 and the proposed ICD-11 was low ( p  = .014). Conclusion: This study provides preliminary evidence for a satisfactory concordance between provisional PTSD prevalence based on the diagnostic criteria for PTSD that are defined using DSM-IV, DSM-5, and proposed ICD-11. This supports the assumption of a set of PTSD core symptoms as suggested in the ICD-11 proposal, when at the same time a satisfactory concordance between ICD-11 proposal and DSM was given. The finding of increased provisional PTSD prevalence under ICD-11 proposal in contrast to ICD-10 can be of guidance for future epidemiological research on PTSD prevalence, especially concerning further investigations on the impact, appropriateness, and usefulness of the time criterion included in ICD-10

Comparison of DSM-5 and proposed ICD-11 criteria for PTSD with DSM-IV and ICD-10: changes in PTSD prevalence in military personnel

PubMed Central

Kuester, Annika; Köhler, Kai; Ehring, Thomas; Knaevelsrud, Christine; Kober, Louisa; Krüger-Gottschalk, Antje; Schäfer, Ingo; Schellong, Julia; Wesemann, Ulrich; Rau, Heinrich

2017-01-01

ABSTRACT Background: Recently, changes have been introduced to the diagnostic criteria for posttraumatic stress disorder (PTSD) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM) and the International Classification of Diseases (ICD). Objectives:This study investigated the effect of the diagnostic changes made from DSM-IV to DSM-5 and from ICD-10 to the proposed ICD-11. The concordance of provisional PTSD prevalence between the diagnostic criteria was examined in a convenience sample of 100 members of the German Armed Forces. Method: Based on questionnaire measurements, provisional PTSD prevalence was assessed according to DSM-IV, DSM-5, ICD-10, and proposed ICD-11 criteria. Consistency of the diagnostic status across the diagnostic systems was statistically evaluated. Results: Provisional PTSD prevalence was the same for DSM-IV and DSM-5 (both 56%) and comparable under DSM-5 versus ICD-11 proposal (48%). Agreement between DSM-IV and DSM-5, and between DSM-5 and the proposed ICD-11, was high (both p < .001). Provisional PTSD prevalence was significantly increased under ICD-11 proposal compared to ICD-10 (30%) which was mainly due to the deletion of the time criterion. Agreement between ICD-10 and the proposed ICD-11 was low (p = .014). Conclusion: This study provides preliminary evidence for a satisfactory concordance between provisional PTSD prevalence based on the diagnostic criteria for PTSD that are defined using DSM-IV, DSM-5, and proposed ICD-11. This supports the assumption of a set of PTSD core symptoms as suggested in the ICD-11 proposal, when at the same time a satisfactory concordance between ICD-11 proposal and DSM was given. The finding of increased provisional PTSD prevalence under ICD-11 proposal in contrast to ICD-10 can be of guidance for future epidemiological research on PTSD prevalence, especially concerning further investigations on the impact, appropriateness, and usefulness of the time criterion included in ICD

[Cognitive emotion regulation of patients qualified for implantation of heart rhythm control device].

PubMed

Ziętalewicz, Urszula; Jędrzejczyk, Jan; Mojkowski, Włodzimierz; Mojkowski, Dariusz

2016-11-25

The aim of the artificial heart stimulation is not only saving lives, but also improvement of the quality of life of patients with cardiac arrhythmias. One of the key dimensions of quality of life is psychological functioning. Until now, little research assess this dimension in patients before the implantation of the heart rhythm control device. The aim of the study was to assess the severity of depression and anxiety and the frequency of the used cognitive emotion regulation strategies and to examine the relationship between them. The study group consisted of 60 people qualified for pacemaker implantation (42 PM patients and 18 ICD): 15 women and 45 men ranging in age from 43 to 85. To assess cognitive emotion regulation strategies Cognitive Emotion Regulation Questionnaire was used, and to assess the severity of depression and anxiety - Mood Assessment Questionnaire. Patients with PM more often than patients with ICD use the strategy of Positive Reappraisal (U = 231.50, p = 0.045). There were no statistically significant differences in the frequency of use of other strategies and severity of depression and anxiety. In PM patients there are negative correlations between the severity of depression and anxiety and the use of Acceptance ( τ = -0.380), a Positive Reappraisal ( τ = -0.278), Positive Refocusing ( τ = -0.366) and between the level of anxiety and Putting into Perspective ( τ = -0.402). In ICD patients there was a positive relationship between anxiety and Cathastrophizing ( τ = 0.324). The severity of depression and anxiety, and emotion regulation strategies in patients qualified for PM implantation in comparison with patients qualified for ICD implantation are similar. Both groups of patients show a good adaptation of the psychological.

Comparison of outcomes in patients undergoing defibrillation threshold testing at the time of implantable cardioverter-defibrillator implantation versus no defibrillation threshold testing.

PubMed

Hall, Burr; Jeevanantham, Vinodh; Levine, Ethan; Daubert, James; McNitt, Scott; Hall, Freburr; Jeevanantham, Vinodh; Levine, Ethan; Daubert, James; McNitt, Scott; Hall, Fred Morady And Frank Pelosiburr; Jeevanantham, Vinodh; Levine, Ethan; Daubert, James; McNitt, Scott; Morady, Fred Morady And Frank Pelosid; Pelosi, Frank

2007-01-01

Inability to perform defibrillation threshold (DFT) testing during implantable cardioverter defibrillator (ICD) implantation due to co-morbidities may influence long-term survival. Retrospective review at The University of Michigan (1999-2004) identified 55 patients undergoing ICD implantation without DFT testing ("No-DFT group"). A randomly selected sample of patients (n = 57) undergoing standard DFT testing ("DFT group") was compared in terms of appropriate shocks, clinical shock efficacy and all-cause mortality. DFT testing was withheld due to hypotension, atrial fibrillation with inability to exclude left atrial thrombus, left ventricular thrombus, CHF and/or ischemia. The No-DFT group had a similar appropriate shock rate, but lower total survival (69.1% vs. 91.2%, p = 0.004) than the DFT group. The No-DFT group had a higher incidence of ventricular fibrillation (VF) episodes (9.1% vs. 3.1%, p = 0.037), and deaths attributable to VF (3 of 17 deaths vs. 0 of 5 deaths) compared to the DFT group. Multivariate analysis found a trend toward increased risk of death in the No-DFT group (HR 3.18, 95% CI 0.82-12.41, p = 0.095) after adjusting for baseline differences in gender distribution, NYHA class and prior CABG. In summary, overall mortality was higher in the No-DFT group. More deaths attributable to VF occurred in the No-DFT group. Thus, DFT testing should therefore remain the standard of care. Nevertheless, ICD therapy should not be withheld in patients who meet appropriate implant criteria simply on the basis of clinical scenarios that preclude routine DFT testing. (Cardiol J 2007; 14: 463-469).

Attitudes of older adults with serious competing health risks toward their implantable cardioverter-defibrillators: a pilot study.

PubMed

Green, Ariel R; Boyd, Cynthia M; Rickard, John; Gomon, Robert; Leff, Bruce

2015-12-23

In elderly heart failure patients, the survival benefit of implantable cardioverter-defibrillators (ICDs) may be attenuated due to competing health risks, and the risk of adverse outcomes magnified. Our objective was to examine older adults' attitudes towards ICD implantation in the context of competing health risks, exploring the determinants of ICD decision-making among a group of patients who had faced the decision in the past. Telephone survey with a qualitative component. Patients were age ≥70 with single- or dual-chamber ICDs from a single academic cardiac device clinic. Health status was assessed with the Vulnerable Elders Survey (VES-13). Responses to open-ended questions were transcribed verbatim; an "editing analysis" approach was used to extract themes. Forty-four ICD recipients participated (mean age 77.5 years). Nineteen participants (43%) had VES-13 scores ≥3, indicating a 50% likelihood of death or functional decline within 2 years. Twenty-one participants (48%) had received prior ICD shocks. Forty participants (91%) said they would "definitely" choose to get an ICD again in their current health. By and large, patients revealed a strong desire to extend life, expressed complete confidence in the lifesaving capabilities of their ICDs, and did not describe consideration of competing health risks. In this pilot telephone survey with a qualitative component, nearly all older adults with ICDs would still choose to get an ICD despite high short-term risk of death or health deterioration. These findings suggest the need to partner more effectively with patients and families to decide how best to use medical technologies, particularly for older adults with competing risks.

Minimally invasive percutaneous pericardial ICD placement in an infant piglet model: Head-to-head comparison with an open surgical thoracotomy approach.

PubMed

Clark, Bradley C; Davis, Tanya D; El-Sayed Ahmed, Magdy M; McCarter, Robert; Ishibashi, Nobuyuki; Jordan, Christopher P; Kane, Timothy D; Kim, Peter C W; Krieger, Axel; Nath, Dilip S; Opfermann, Justin D; Berul, Charles I

2016-05-01

Epicardial implantable cardioverter-defibrillator (ICD) placement in infants, children, and patients with complex cardiac anatomy requires an open surgical thoracotomy and is associated with increased pain, longer length of stay, and higher cost. The purpose of this study was to compare an open surgical epicardial placement approach with percutaneous pericardial placement of an ICD lead system in an infant piglet model. Animals underwent either epicardial placement by direct suture fixation through a left thoracotomy or minimally invasive pericardial placement with thoracoscopic visualization. Initial lead testing and defibrillation threshold testing (DFT) were performed. After the 2-week survival period, repeat lead testing and DFT were performed before euthanasia. Minimally invasive placement was performed in 8 piglets and open surgical placement in 7 piglets without procedural morbidity or mortality. The mean initial DFT value was 10.5 J (range 3-28 J) in the minimally invasive group and 10.0 J (range 5-35 J) in the open surgical group (P = .90). After the survival period, the mean DFT value was 12.0 J (range 3-20 J) in the minimally invasive group and 12.3 J (range 3-35 J) in the open surgical group (P = .95). All lead and shock impedances, R-wave amplitudes, and ventricular pacing thresholds remained stable throughout the survival period. Compared with open surgical epicardial ICD lead placement, minimally invasive pericardial placement demonstrates an equivalent ability to effectively defibrillate the heart and has demonstrated similar lead stability. With continued technical development and operator experience, the minimally invasive method may provide a viable alternative to epicardial ICD lead placement in infants, children, and adults at risk of sudden cardiac death. Copyright © 2016 Heart Rhythm Society. All rights reserved.

Posttraumatic stress symptoms and predicted mortality in patients with implantable cardioverter-defibrillators: results from the prospective living with an implanted cardioverter-defibrillator study.

PubMed

Ladwig, Karl-Heinz; Baumert, Jens; Marten-Mittag, Birgitt; Kolb, Christof; Zrenner, Bernhard; Schmitt, Claus

2008-11-01

Cardiac disease and treatment with an implantable cardioverter-defibrillator (ICD) may be psychologically traumatic. Posttraumatic stress disorder (PTSD) is generally overlooked in cardiac patients, and no study to date (to our knowledge) has evaluated the effect of PTSD symptoms on the prognosis in patients with ICDs. To test whether PTSD symptoms at baseline predict long-term mortality risk in patients with ICDs. Prospective cohort study with a mean follow-up period of 5.1 years, accounting for 743 person-years observed. Data were derived from the Living With an Implanted Cardioverter-Defibrillator-Study, which initially included 211 patients with ICDs routinely attending the German Heart Center Munich outpatient clinic. The Impact of Event Scale-Revised was used in 147 patients (125 men and 22 women) who qualified for the "A" criterion of PTSD (survival of a life-threatening event). Thirty-eight patients scoring in the upper quartile of the scale constituted the PTSD index group. Mortality risk per 1000 person-years as assessed by Cox proportional hazards regression analysis based on an appropriate model fit (area under the curve, >0.80). Index patients experienced more anxiety and depression, had more cardiac symptoms, but showed no differences in left ventricular ejection fraction status or extent of ICD discharges compared with non-index patients. Forty-five patients (30.6%) died during the follow-up period. The relative mortality risk (multivariate adjusted for age, sex, diabetes mellitus, left ventricular ejection fraction, beta-blocker prescription, prior resuscitation, ICD shocks received, depression, and anxiety) hazard ratio was 3.45 (95% confidence interval, 1.57-7.60; P = .002) for the PTSD group. Compared with 55 fatal events per 1000 person-years in patients without PTSD, the long-term absolute mortality risk accounted for 80 fatal events per 1000 person-years in patients with PTSD. The adverse effect of PTSD symptoms on the long-term mortality risk

Pre- and post-operative dizziness, tinnitus, and taste disturbances among cochlear implant recipients.

PubMed

Mikkelsen, K S; Ovesen, T; Swan, C Z

2017-04-01

To determine the pre- and post-operative prevalence of dizziness, tinnitus and taste disturbances in adult cochlear implant recipients. A questionnaire regarding pre- and post-operative dizziness, tinnitus and taste disturbances was sent to 170 cochlear implant recipients implanted between January 2003 and March 2009. Seventy-seven patients (41 per cent) responded. Pre-operatively, 20 per cent of the participants experienced dizziness, 52 per cent experienced tinnitus and 3 per cent experienced taste disturbances. Post-operative dizziness developed in 46 per cent of patients and resolved in the majority of these; however, 15 per cent reported dizziness more than six months after implantation. Tinnitus worsened in 25 per cent of patients, whereas 73 per cent reported attenuation or termination of tinnitus. Post-operatively, tinnitus developed in 12 per cent and taste disturbances developed in 17 per cent of the patients. The high prevalence of dizziness, tinnitus and taste disturbances reported by cochlear implant recipients necessitates that assessment of symptoms related to inner ear and chorda tympani damage are included when evaluating operative results.

The implantable cardioverter defibrillator: technology, indications, and impact on cardiovascular survival.

PubMed

Bhatia, Atul; Cooley, Ryan; Berger, Marcie; Blanck, Zalmen; Dhala, Anwer; Sra, Jasbir; Axtell-Mcbride, Kathleen; Vandervort, Cheryl; Akhtar, Masood

2004-06-01

Since the introduction of the implantable cardioverter defibrillator (ICD) for the management of patients with high risk of arrhythmic SCD, there has been increasing use of this device. Its basic promise to effectively terminate ventricular tachycardia (VT)-ventricular fibrillation (VF) has been repeatedly met. In several randomized trials, the ICD has been shown to be superior to conventional anti-arrhythmic therapy, both in patients with documented VT-VF (secondary prevention) and those with high risk such as left ventricular ejection fraction and no prior sustained VT-VF (primary prevention). In both groups, the ICD showed overall and cardiac mortality reduction. The device now can more accurately detect VT-VF and differentiate these from other arrhythmias through a series of algorithms and direct-chamber sensing. Therapy options include painless antitachycardia pacing, low-energy cardioversion, and high-energy defibrillation. The technique implant is now simple as a pacemaker with one lead attached to an active (hot) can functioning as the other electrode. Among other improvements is its weight, volume, multiprogrammability, and storage of information,dual-chamber pacing and sensing, dual-chamber defibrillation, and addition of biventricular pacing for cardiac synchronization. It is anticipated that further improvement in ICD technology will take place and the list of indications will grow.

Health Care Utilization and Expenditures Associated With Remote Monitoring in Patients With Implantable Cardiac Devices.

PubMed

Ladapo, Joseph A; Turakhia, Mintu P; Ryan, Michael P; Mollenkopf, Sarah A; Reynolds, Matthew R

2016-05-01

Several randomized trials and decision analysis models have found that remote monitoring may reduce health care utilization and expenditures in patients with cardiac implantable electronic devices (CIEDs), compared with in-office monitoring. However, little is known about the generalizability of these findings to unselected populations in clinical practice. To compare health care utilization and expenditures associated with remote monitoring and in-office monitoring in patients with CIEDs, we used Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases. We selected patients newly implanted with an implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy defibrillator (CRT-D), or permanent pacemaker (PPM), in 2009, who had continuous health plan enrollment 2 years after implantation. Generalized linear models and propensity score matching were used to adjust for confounders and estimate differences in health care utilization and expenditures in patients with remote or in-office monitoring. We identified 1,127; 427; and 1,295 pairs of patients with a similar propensity for receiving an ICD, CRT-D, or PPM, respectively. Remotely monitored patients with ICDs experienced fewer emergency department visits resulting in discharge (p = 0.050). Remote monitoring was associated with lower health care expenditures in office visits among patients with PPMs (p = 0.025) and CRT-Ds (p = 0.006) and lower total inpatient and outpatient expenditures in patients with ICDs (p <0.0001). In conclusion, remote monitoring of patients with CIEDs may be associated with reductions in health care utilization and expenditures compared with exclusive in-office care. Copyright © 2016 Elsevier Inc. All rights reserved.

Current Indications for Implantable Cardioverter Defibrillators in Non-Ischemic Cardiomyopathies and Channelopathies.

PubMed

González-Torrecilla, Esteban; Arenal, Angel; Atienza, Felipe; Datino, Tomás; Bravo, Loreto; Ruiz, Pablo; Ávila, Pablo; Fernández-Avilés, Francisco

2015-01-01

Current indications for implantable cardioverter defibrillators (ICDs) in patients with channelopathies and cardiomyopathies of non-ischemic origin are mainly based on non-randomized evidence. In patients with nonischemic dilated cardiomyopathy (NIDCM), there is a tendency towards a beneficial effect on total mortality of ICD therapy in patients with significant left ventricular (LV) dysfunction. Although an important reduction in sudden cardiac death (SCD) seems to be clearly demonstrated in these patients, a net beneficial effect on total mortality is unclear mostly in cases with good functional status. Risk stratification has been changing over the last two decades in patients with hypertrophic cardiomyopathy (HCM). Its risk profile has been delineated in parallel with the beneficial effect of ICD in high risk patients. Observational results based on "appropriate" ICD interventions do support its usefulness both in primary and secondary SCD prevention in these patients. Novel risk models quantify the rate of sudden cardiac death in these patients on individual basis. Less clear risk stratification is available for cases of arrhythmogenic right ventricular cardiomyopathy (ARVC) and in other uncommon familiar cardiomyopathies. Main features of risk stratification vary among the different channelopathies (long QT syndrome -LQTS-, Brugada syndrome, etc) with great debate on the management of asymptomatic patients. For most familiar cardiomyopathies, ICD therapy is the only accepted strategy in the prevention of SCD. So far, genetic testing has a limited role in risk evaluation and management of the individual patient. This review aims to summarize these criticisms and to refine the current indications of ICD implantation in patients with cardiomyopathies and major channelopathies.

Measuring diagnoses: ICD code accuracy.

PubMed

O'Malley, Kimberly J; Cook, Karon F; Price, Matt D; Wildes, Kimberly Raiford; Hurdle, John F; Ashton, Carol M

2005-10-01

To examine potential sources of errors at each step of the described inpatient International Classification of Diseases (ICD) coding process. The use of disease codes from the ICD has expanded from classifying morbidity and mortality information for statistical purposes to diverse sets of applications in research, health care policy, and health care finance. By describing a brief history of ICD coding, detailing the process for assigning codes, identifying where errors can be introduced into the process, and reviewing methods for examining code accuracy, we help code users more systematically evaluate code accuracy for their particular applications. We summarize the inpatient ICD diagnostic coding process from patient admission to diagnostic code assignment. We examine potential sources of errors at each step and offer code users a tool for systematically evaluating code accuracy. Main error sources along the "patient trajectory" include amount and quality of information at admission, communication among patients and providers, the clinician's knowledge and experience with the illness, and the clinician's attention to detail. Main error sources along the "paper trail" include variance in the electronic and written records, coder training and experience, facility quality-control efforts, and unintentional and intentional coder errors, such as misspecification, unbundling, and upcoding. By clearly specifying the code assignment process and heightening their awareness of potential error sources, code users can better evaluate the applicability and limitations of codes for their particular situations. ICD codes can then be used in the most appropriate ways.

Impact of early complications on outcomes in patients with implantable cardioverter-defibrillator for primary prevention.

PubMed

Ascoeta, Maria Soledad; Marijon, Eloi; Defaye, Pascal; Klug, Didier; Beganton, Frankie; Perier, Marie-Cécile; Gras, Daniel; Algalarrondo, Vincent; Deharo, Jean-Claude; Leclercq, Christophe; Fauchier, Laurent; Babuty, Dominique; Bordachar, Pierre; Sadoul, Nicolas; Boveda, Serge; Piot, Olivier

2016-05-01

The lifesaving benefit of implantable cardioverter-defibrillators (ICDs) has been demonstrated. Their use has increased considerably in the past decade, but related complications have become a major concern. The purpose of this study was to assess the incidence and effect on outcomes of early (≤30 days) complications after ICD implantation for primary prevention in a large French population. We analyzed data from 5539 patients from the multicenter French DAI-PP (Défibrillateur Automatique Implantable-Prévention Primaire) registry (2002-2012) who had coronary artery disease or dilated cardiomyopathy and were implanted with an ICD for primary prevention. Overall, early complications occurred in 707 patients (13.5%), mainly related to lead dislodgment or hematoma (57%). Independent factors associated with occurrence of early complications were severe renal impairment (odds ratio [OR] 1.66, 95% confidence interval [CI] 1.17-2.37, P = .02), age ≥75 years (OR 1.01, 95% CI 1.00-1.02, P = .03), cardiac resynchronization therapy (OR 1.58, 95% CI 1.16-2.17, P = .01), and anticoagulant therapy (OR 1.28, 95% CI 1.02-1.61, P = .03). During a mean ± SD follow-up of 3.1 ± 2.3 years, 824 (15.8%) patients experienced ≥1 late complication (>30 days), and 782 (14.9%) patients died. After adjustment, early complications remained associated with occurrence of late complications (OR 2.15, 95% CI 1.73-2.66, P < .0001) and mortality (OR 1.70, 95% CI 1.34-2.17, P = .003). Early complications are common after ICD implantation for primary prevention, occurring in 1 in 7 patients, and are associated with an increased risk of late complications and overall mortality. Further studies are needed to investigate the underlying mechanisms of such associations. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

External closed-circuit cooling system for management of patients after device implantation: A feasibility study.

PubMed

Giofrè, Fabrizio; Ferrari, Paola; Leidi, Cristina; Foschi, Maria Laura; Senni, Michele; De Filippo, Paolo

2017-08-15

In the first 24h after pacemaker or implantable cardioverter/defibrillator (ICD) implantation or replacement, the occurrence of hematoma and pain in the surgically treated region is not infrequent and may result in re-intervention and/or more severe complications, such as infections. Currently, the post-implant phase management is very empiric. The aim of this study was to test the clinical applicability and usefulness of an external close-circuit cooling system for the management of the early post-implant period in patients with high risk of hematoma due to anticoagulant and/or antiplatelet therapy. We studied 135 patients (78M; 71±11years) with high risk of hematoma occurrence after pace-maker (63 patients) or ICD (72 patients) implantation or replacement. Immediately after the intervention, a closed-circuit cooling system (CAREPACE™ system, Zamar, Italy) was externally applied on the pre-pectoral region to each patient and maintained for 24h. The system has a compressive pad and a refrigerating circuit in which non-toxic glycolic fluid is pumped. The fluid temperature was set and kept at 5°C for the whole period. The compressive and cooling effect of the system was well tolerated by all the patients at the temperature set. Four patients complained of noise due to machine operation, but in none the treatment was interrupted. The average length of hospital stay was 2.8±0.4days. No clinically significant hematoma was observed at discharge and after one month follow-up visit. This new system can be used for the management of the early phase after device implantation or replacement and appears clinically useful and well tolerated. Further studies on a larger scale are needed to test the potential reduction of post-intervention complications and the cost-effectiveness of this device. Copyright © 2017 Elsevier B.V. All rights reserved.

Application of radiofrequency energy in surgical and interventional procedures: are there interactions with ICDs?

PubMed

Fiek, Michael; Dorwarth, Uwe; Durchlaub, Ilka; Janko, Sabine; Von Bary, Christian; Steinbeck, Gerhard; Hoffmann, Ellen

2004-03-01

During surgical and interventional procedures, interference may occur between ICDs and electrical cautery or with the application of RF energy. This may lead to the false induction of ICD therapies or could even result in device malfunction, which represents a potential perioperative hazard for the patient. This study analyzed the intraoperative interactions in 45 consecutive ICD patients in reference to different surgical and interventional procedures. A total of 33 surgical operations (general surgery [n = 14], urologic [n = 5], abdominal [n = 10], gynecological [n = 2], thoracic [n = 1], neurosurgical [n = 1]) and 12 interventional therapies (RF catheter ablation [n = 10], endoscopic papillotomy [n = 2]) were performed. The ICD devices were all located in left pectoral position and consisted of 25 single and 20 dual chamber defibrillators. During the procedure, tachyarrhythmia detection (VF 296 +/- 20 ms, VT 376 +/- 49 ms) of the devices was maintained active (monitoring mode), only ICD therapies were inactivated. The indifferent electrode of the electrical cauter/RF generator was placed in standard positions (right/left mid-femoral position [n = 27/8], thoracic spine area [n = 10]). After the procedure, the ICD memory was checked for detections and for changes in the programming. There was no oversensing, reprogramming, or damage of any defibrillator caused by RF energy. Despite the lack of undesired interactions, ICDs should be inactivated preoperatively to assure maximum patient safety. However, should inactivation not be possible, or the achievement uncertain, electromagnetic interference is highly unlikely.

The Significance of Shocks in Implantable Cardioverter Defibrillator Recipients

PubMed Central

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

2016-01-01

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

Measuring Diagnoses: ICD Code Accuracy

PubMed Central

O'Malley, Kimberly J; Cook, Karon F; Price, Matt D; Wildes, Kimberly Raiford; Hurdle, John F; Ashton, Carol M

2005-01-01

Objective To examine potential sources of errors at each step of the described inpatient International Classification of Diseases (ICD) coding process. Data Sources/Study Setting The use of disease codes from the ICD has expanded from classifying morbidity and mortality information for statistical purposes to diverse sets of applications in research, health care policy, and health care finance. By describing a brief history of ICD coding, detailing the process for assigning codes, identifying where errors can be introduced into the process, and reviewing methods for examining code accuracy, we help code users more systematically evaluate code accuracy for their particular applications. Study Design/Methods We summarize the inpatient ICD diagnostic coding process from patient admission to diagnostic code assignment. We examine potential sources of errors at each step and offer code users a tool for systematically evaluating code accuracy. Principle Findings Main error sources along the “patient trajectory” include amount and quality of information at admission, communication among patients and providers, the clinician's knowledge and experience with the illness, and the clinician's attention to detail. Main error sources along the “paper trail” include variance in the electronic and written records, coder training and experience, facility quality-control efforts, and unintentional and intentional coder errors, such as misspecification, unbundling, and upcoding. Conclusions By clearly specifying the code assignment process and heightening their awareness of potential error sources, code users can better evaluate the applicability and limitations of codes for their particular situations. ICD codes can then be used in the most appropriate ways. PMID:16178999

Long-Term Clinical Outcome of Arrhythmogenic Right Ventricular Cardiomyopathy in Individuals With a p.S358L Mutation in TMEM43 Following Implantable Cardioverter Defibrillator Therapy.

PubMed

Hodgkinson, Kathleen A; Howes, A J; Boland, Paul; Shen, Xiou Seegar; Stuckless, Susan; Young, Terry-Lynn; Curtis, Fiona; Collier, Ashley; Parfrey, Patrick S; Connors, Sean P

2016-03-01

We previously showed a survival benefit of the implantable cardioverter defibrillator (ICD) in males with arrhythmogenic right ventricular cardiomyopathy caused by a p.S358L mutation in TMEM43. We present long-term data (median follow-up 8.5 years) after ICD for primary (PP) and secondary prophylaxis in males and females, determine whether ICD discharges for ventricular tachycardia/ventricular fibrillation were equivalent to an aborted death, and assess relevant clinical predictors. We studied 24 multiplex families segregating an autosomal dominant p.S358L mutation in TMEM43. We compared survival in 148 mutation carriers with an ICD to 148 controls matched for age, sex, disease status, and family. Of 80 male mutation carriers with ICDs (median age at implantation 31 years), 61 (76%) were for PP; of 68 females (median age at implantation 43 years), 66 (97%) were for PP. In males, irrespective of indication, survival was better in the ICD groups compared with control groups (relative risk 9.3 [95% confidence interval 3.3-26] for PP and 9.7 [95% confidence interval 3.2-29.6] for secondary prophylaxis). For PP females, the relative risk was 3.6 (95% confidence interval 1.3-9.5). ICD discharge-free survival for ventricular tachycardia/ventricular fibrillation ≥ 240 beats per minute was equivalent to the control survival rate. Ectopy (≥ 1000 premature ventricular complexes/24 hours) was the only independent clinical predictor of ICD discharge in males, and no predictor was identified in females. ICD therapy is indicated for PP in postpubertal males and in females ≥ 30 years with the p.S358L TMEM43 mutation. ICD termination of rapid ventricular tachycardia/ventricular fibrillation can reasonably be considered an aborted death. © 2016 American Heart Association, Inc.

Effect of a Reminder Statement on Echocardiography Reports on Referrals for Implantable Cardioverter-Defibrillators for Primary Prevention.

PubMed

Chokshi, Moulin; McNamara, Robert L; Rajeswaran, Yasotha; Lampert, Rachel

2017-02-01

Numerous trials show the benefit of implantable cardioverter-defibrillators (ICDs) for primary prevention in patients with low ejection fraction (EF), a class I indication. However, underutilization is well documented. We retrospectively reviewed charts to see whether placing a reminder statement into echocardiogram reports for appropriate patients increased adherence to guidelines. From January through June 2013, a brief reminder of the ICD guidelines was automatically inserted into echocardiogram reports with EF ≤ 35% (reminder period). Charts were reviewed to determine if these patients (1) were referred to Electrophysiology (EP) within 6 months of the index echo and (2) received an ICD within 6 months of EP referral. Chart review of all patients who had an echocardiogram performed between March and August 2012 with an EF ≤ 35% provided a control period. More patients were referred to EP in the reminder period compared with control period, 68% (54 of 80) versus 51% (53 of 104), p = 0.03. There was also a higher rate of discussions in the reminder period between patients and physicians about ICD therapy (71% vs 54%, p = 0.02). Among patients appropriate for ICD, 52% of patients during the reminder period received an ICD versus 38% of patients during the control period (p = 0.11). A simple reminder statement on echocardiography reports led to a significant improvement in appropriate EP referrals and a trend toward increased ICD implantation in appropriate patients. Copyright © 2016 Elsevier Inc. All rights reserved.

Effect of radiation therapy on permanent pacemaker and implantable cardioverter-defibrillator function.

PubMed

Makkar, Akash; Prisciandaro, Joann; Agarwal, Sunil; Lusk, Morgan; Horwood, Laura; Moran, Jean; Fox, Colleen; Hayman, James A; Ghanbari, Hamid; Roberts, Brett; Belardi, Diego; Latchamsetty, Rakesh; Crawford, Thomas; Good, Eric; Jongnarangsin, Krit; Bogun, Frank; Chugh, Aman; Oral, Hakan; Morady, Fred; Pelosi, Frank

2012-12-01

Radiation therapy's (RT's) effects on cardiac implantable electronic devices (CIEDs) such as implantable cardioverter-defibrillators (ICDs) and pacemakers (PMs) are not well established, leading to device removal or relocation in preparation for RT. To determine the effect of scattered RT on CIED performance. We analyzed 69 patients--50 (72%) with PMs and 19 (28%) with ICDs--receiving RT at the University of Michigan. Collected data included device model, anatomic location, and treatment beam energies, treatment type, and estimated dose to the device. Patients were treated with either high-energy (16-MV) and/or low-energy (6 MV) photon beams with or without electron beams (6-16 MeV). The devices were interrogated with pre- and post-RT and/or weekly with either in-treatment or home interrogation, depending on the patient's dependence on the device and the estimated or measured delivered dose. Outcomes analyzed were inappropriate ICD therapies, device malfunctions, or device-related clinical events. The PMs were exposed to 84.4 ± 99.7 cGy of radiation, and the ICDs were exposed to 92.1 ± 72.6 cGy of radiation. Two patients with ICDs experienced a partial reset of the ICD with the loss of historic diagnostic data after receiving 123 and 4 cGy, respectively. No device malfunction or premature battery depletion was observed at 6-month follow-up from RT completion. CIED malfunction due to indirect RT exposure is uncommon. Regular in-treatment or home interrogation should be done to detect and treat these events and to ensure that diagnostic data are preserved. Copyright © 2012 Elsevier Inc. All rights reserved.

ICD-9-CM and ICD-10-CM mapping of the AAST Emergency General Surgery disease severity grading systems: Conceptual approach, limitations, and recommendations for the future.

PubMed

Utter, Garth H; Miller, Preston R; Mowery, Nathan T; Tominaga, Gail T; Gunter, Oliver; Osler, Turner M; Ciesla, David J; Agarwal, Suresh K; Inaba, Kenji; Aboutanos, Michel B; Brown, Carlos V R; Ross, Steven E; Crandall, Marie L; Shafi, Shahid

2015-05-01

The American Association for the Surgery of Trauma (AAST) recently established a grading system for uniform reporting of anatomic severity of several emergency general surgery (EGS) diseases. There are five grades of severity for each disease, ranging from I (lowest severity) to V (highest severity). However, the grading process requires manual chart review. We sought to evaluate whether International Classification of Diseases, 9th and 10th Revisions, Clinical Modification (ICD-9-CM, ICD-10-CM) codes might allow estimation of AAST grades for EGS diseases. The Patient Assessment and Outcomes Committee of the AAST reviewed all available ICD-9-CM and ICD-10-CM diagnosis codes relevant to 16 EGS diseases with available AAST grades. We then matched grades for each EGS disease with one or more ICD codes. We used the Official Coding Guidelines for ICD-9-CM and ICD-10-CM and the American Hospital Association's "Coding Clinic for ICD-9-CM" for coding guidance. The ICD codes did not allow for matching all five AAST grades of severity for each of the 16 diseases. With ICD-9-CM, six diseases mapped into four categories of severity (instead of five), another six diseases into three categories of severity, and four diseases into only two categories of severity. With ICD-10-CM, five diseases mapped into four categories of severity, seven diseases into three categories, and four diseases into two categories. Two diseases mapped into discontinuous categories of grades (two in ICD-9-CM and one in ICD-10-CM). Although resolution is limited, ICD-9-CM and ICD-10-CM diagnosis codes might have some utility in roughly approximating the severity of the AAST grades in the absence of more precise information. These ICD mappings should be validated and refined before widespread use to characterize EGS disease severity. In the long-term, it may be desirable to develop alternatives to ICD-9-CM and ICD-10-CM codes for routine collection of disease severity characteristics.

Development of the ICD-10 simplified version and field test.

PubMed

Paoin, Wansa; Yuenyongsuwan, Maliwan; Yokobori, Yukiko; Endo, Hiroyoshi; Kim, Sukil

2018-05-01

The International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10) has been used in various Asia-Pacific countries for more than 20 years. Although ICD-10 is a powerful tool, clinical coding processes are complex; therefore, many developing countries have not been able to implement ICD-10-based health statistics (WHO-FIC APN, 2007). This study aimed to simplify ICD-10 clinical coding processes, to modify index terms to facilitate computer searching and to provide a simplified version of ICD-10 for use in developing countries. The World Health Organization Family of International Classifications Asia-Pacific Network (APN) developed a simplified version of the ICD-10 and conducted field testing in Cambodia during February and March 2016. Ten hospitals were selected to participate. Each hospital sent a team to join a training workshop before using the ICD-10 simplified version to code 100 cases. All hospitals subsequently sent their coded records to the researchers. Overall, there were 1038 coded records with a total of 1099 ICD clinical codes assigned. The average accuracy rate was calculated as 80.71% (66.67-93.41%). Three types of clinical coding errors were found. These related to errors relating to the coder (14.56%), those resulting from the physician documentation (1.27%) and those considered system errors (3.46%). The field trial results demonstrated that the APN ICD-10 simplified version is feasible for implementation as an effective tool to implement ICD-10 clinical coding for hospitals. Developing countries may consider adopting the APN ICD-10 simplified version for ICD-10 code assignment in hospitals and health care centres. The simplified version can be viewed as an introductory tool which leads to the implementation of the full ICD-10 and may support subsequent ICD-11 adoption.

Validation of the Combined Comorbidity Index of Charlson and Elixhauser to Predict 30-Day Mortality Across ICD-9 and ICD-10.

PubMed

Simard, Marc; Sirois, Caroline; Candas, Bernard

2018-05-01

To validate and compare performance of an International Classification of Diseases, tenth revision (ICD-10) version of a combined comorbidity index merging conditions of Charlson and Elixhauser measures against individual measures in the prediction of 30-day mortality. To select a weight derivation method providing optimal performance across ICD-9 and ICD-10 coding systems. Using 2 adult population-based cohorts of patients with hospital admissions in ICD-9 (2005, n=337,367) and ICD-10 (2011, n=348,820), we validated a combined comorbidity index by predicting 30-day mortality with logistic regression. To appreciate performance of the Combined index and both individual measures, factors impacting indices performance such as population characteristics and weight derivation methods were accounted for. We applied 3 scoring methods (Van Walraven, Schneeweiss, and Charlson) and determined which provides best predictive values. Combined index [c-statistics: 0.853 (95% confidence interval: CI, 0.848-0.856)] performed better than original Charlson [0.841 (95% CI, 0.835-0.844)] or Elixhauser [0.841 (95% CI, 0.837-0.844)] measures on ICD-10 cohort. All weight derivation methods provided close high discrimination results for the Combined index (Van Walraven: 0.852, Schneeweiss: 0.851, Charlson: 0.849). Results were consistent across both coding systems. The Combined index remains valid with both ICD-9 and ICD-10 coding systems and the 3 weight derivation methods evaluated provided consistent high performance across those coding systems.

Accuracy of a digital impression system based on parallel confocal laser technology for implants with consideration of operator experience and implant angulation and depth.

PubMed

Giménez, Beatriz; Özcan, Mutlu; Martínez-Rus, Francisco; Pradíes, Guillermo

2014-01-01

To evaluate the accuracy of a digital impression system based on parallel confocal red laser technology, taking into consideration clinical parameters such as operator experience and angulation and depth of implants. A maxillary master model with six implants (located bilaterally in the second molar, second premolar, and lateral incisor positions) was fitted with six polyether ether ketone scan bodies. One second premolar implant was placed with 30 degrees of mesial angulation; the opposite implant was positioned with 30 degrees of distal angulation. The lateral incisor implants were placed 2 or 4 mm subgingivally. Two experienced and two inexperienced operators performed intraoral scanning. Five different interimplant distances were then measured. The files obtained from the scans were imported with reverse-engineering software. Measurements were then made with a coordinate measurement machine, with values from the master model used as reference values. The deviations from the actual values were then calculated. The differences between experienced and inexperienced operators and the effects of different implant angulations and depths were compared statistically. Overall, operator 3 obtained significantly less accurate results. The angulated implants did not significantly influence accuracy compared to the parallel implants. Differences were found in the amount of error in the different quadrants. The second scanned quadrant had significantly worse results than the first scanned quadrant. Impressions of the implants placed at the tissue level were less accurate than implants placed 2 and 4 mm subgingivally. The operator affected the accuracy of measurements, but the performance of the operator was not necessarily dependent on experience. Angulated implants did not decrease the accuracy of the digital impression system tested. The scanned distance affected the predictability of the accuracy of the scanner, and the error increased with the increased length of the

Implantable cardioverter-defibrillator therapy in Brugada syndrome: a 20-year single-center experience.

PubMed

Conte, Giulio; Sieira, Juan; Ciconte, Giuseppe; de Asmundis, Carlo; Chierchia, Gian-Battista; Baltogiannis, Giannis; Di Giovanni, Giacomo; La Meir, Mark; Wellens, Francis; Czapla, Jens; Wauters, Kristel; Levinstein, Moises; Saitoh, Yukio; Irfan, Ghazala; Julià, Justo; Pappaert, Gudrun; Brugada, Pedro

2015-03-10

Patients with Brugada syndrome and aborted sudden cardiac death or syncope have higher risks for ventricular arrhythmias (VAs) and should undergo implantable cardioverter-defibrillator (ICD) placement. Device-based management of asymptomatic patients is controversial. ICD therapy is associated with high rates of inappropriate shocks and device-related complications. The objective of this study was to investigate clinical features, management, and long-term follow-up of ICD therapy in patients with Brugada syndrome. Patients presenting with spontaneous or drug-induced Brugada type 1 electrocardiographic findings, who underwent ICD implantation and continuous follow-up at a single institution, were eligible for this study. A total of 176 consecutive patients were included. During a mean follow-up period of 83.8 ± 57.3 months, spontaneous sustained VAs occurred in 30 patients (17%). Eight patients (4.5%) died. Appropriate ICD shocks occurred in 28 patients (15.9%), and 33 patients (18.7%) had inappropriate shocks. Electrical storm occurred in 4 subjects (2.3%). Twenty-eight patients (15.9%) experienced device-related complications. In multivariate Cox regression analysis, aborted sudden cardiac death and VA inducibility on electrophysiologic studies were independent predictors of appropriate shock occurrence. ICD therapy was an effective strategy in Brugada syndrome, treating potentially lethal arrhythmias in 17% of patients during long-term follow-up. Appropriate shocks were significantly associated with the presence of aborted sudden cardiac death but also occurred in 13% of asymptomatic patients. Risk stratification by electrophysiologic study may identify asymptomatic patients at risk for arrhythmic events and could be helpful in investigating syncope not related to VAs. ICD placement is frequently associated with device-related complications, and rates of inappropriate shocks remain high regardless of careful device programming. Copyright © 2015 American

Image Quality of Cardiac Magnetic Resonance Imaging in Patients With an Implantable Cardioverter Defibrillator System Designed for the Magnetic Resonance Imaging Environment.

PubMed

Schwitter, Juerg; Gold, Michael R; Al Fagih, Ahmed; Lee, Sung; Peterson, Michael; Ciuffo, Allen; Zhang, Yan; Kristiansen, Nina; Kanal, Emanuel; Sommer, Torsten

2016-05-01

Recently, magnetic resonance (MR)-conditional implantable cardioverter defibrillator (ICD) systems have become available. However, associated cardiac MR image (MRI) quality is unknown. The goal was to evaluate the image quality performance of various cardiac MR sequences in a multicenter trial of patients implanted with an MR-conditional ICD system. The Evera-MRI trial enrolled 275 patients in 42 centers worldwide. There were 263 patients implanted with an Evera-MRI single- or dual-chamber ICD and randomized to controls (n=88) and MRI (n=175), 156 of whom underwent a protocol-required MRI (9-12 weeks post implant). Steady-state-free-precession (SSFP) and fast-gradient-echo (FGE) sequences were acquired in short-axis and horizontal long-axis orientations. Qualitative and quantitative assessment of image quality was performed by using a 7-point scale (grades 1-3: good quality, grades 6-7: nondiagnostic) and measuring ICD- and lead-related artifact size. Good to moderate image quality (grades 1-5) was obtained in 53% and 74% of SSFP and FGE acquisitions, respectively, covering the left ventricle, and in 69% and 84%, respectively, covering the right ventricle. Odds for better image quality were greater for right ventricle versus left ventricle (odds ratio, 1.8; 95% confidence interval, 1.5-2.2; P<0.0001) and greater for FGE versus SSFP (odds ratio, 3.5; 95% confidence interval, 2.5-4.8; P<0.0001). Compared with SSFP, ICD-related artifacts on FGE were smaller (141±65 versus 75±57 mm, respectively; P<0.0001). Lead artifacts were much smaller than ICD artifacts (P<0.0001). FGE yields good to moderate quality in 74% of left ventricle and 84% of right ventricle acquisitions and performs better than SSFP in patients with an MRI-conditional ICD system. In these patients, cardiac MRI can offer diagnostic information in most cases. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02117414. © 2016 American Heart Association, Inc.

Implantation techniques and chronic lead parameters of biventricular pacing dual-chamber defibrillators.

PubMed

Daoud, Emile G; Kalbfleisch, Steven J; Hummel, John D; Weiss, Raul; Augustini, Ralph S; Duff, Steven B; Polsinelli, Georgia; Castor, John; Meta, Tejas

2002-10-01

The aim of this study is to describe implantation techniques and lead performance for biventricular pacing, dual-chamber implantable cardioverter defibrillators (ICDs). A dual-chamber ICD with biventricular pacing was implanted in 87 patients with congestive heart failure (ejection fraction: 0.21 +/- 0.09), prolonged QRS duration (161 +/- 22 msec), and an indication for ICD therapy. Left ventricular pacing was achieved with a thoracotomy approach (n = 21) or a nonthoracotomy approach (n = 66). With a thoracotomy, biventricular devices were implanted successfully in all patients. During follow-up (17 +/- 11 months), 9 patients died (43%), 2 underwent transplantation, and 2 required left ventricular lead revision. At last follow-up, biventricular sensing and capture threshold were 11 +/- 5 mV and 1.5 +/- 0.8 V, respectively. For nonthoracotomy procedures, two types of coronary sinus (CS) leads were implanted: an over-the-wire lead (n = 45) and a shaped lead (n = 21). The rate of successful implantation (overall: 89%) (over-the-wire 93% vs shaped 81%; P = 0.1) and durations for CS lead placement (66 +/- 50 vs 58 +/- 34 min, P = 0.6) and the procedure (133 +/- 58 vs 129 +/- 33 min, P = 0.8) were not different between the two CS leads. During follow-up (11 +/- 9 months), 9 patients died (14%), and the shaped CS lead dislodged in 3 patients (3 shaped vs 0 over-the-wire, P = 0.01). At last follow-up, biventricular sensing and capture threshold were 10 +/- 4 mV and 1.8 +/- 0.7 V, respectively, and there was no difference between over-the-wire and shaped leads. By multivariate analysis, mortality was associated with absence of spironolactone therapy but not procedural features. Nonthoracotomy CS lead implantation is feasible, with a success rate of about 90% and few adverse events. For the remaining 10%, a thoracotomy approach can be completed safely in these ill patients without increased risk for death.

Preclinical evaluation of implantable cardioverter-defibrillator developed for magnetic resonance imaging use.

PubMed

Gold, Michael R; Kanal, Emanuel; Schwitter, Juerg; Sommer, Torsten; Yoon, Hyun; Ellingson, Michael; Landborg, Lynn; Bratten, Tara

2015-03-01

Many patients with an implantable cardioverter-defibrillator (ICD) have indications for magnetic resonance imaging (MRI). However, MRI is generally contraindicated in ICD patients because of potential risks from hazardous interactions between the MRI and ICD system. The purpose of this study was to use preclinical computer modeling, animal studies, and bench and scanner testing to demonstrate the safety of an ICD system developed for 1.5-T whole-body MRI. MRI hazards were assessed and mitigated using multiple approaches: design decisions to increase safety and reliability, modeling and simulation to quantify clinical MRI exposure levels, animal studies to quantify the physiologic effects of MRI exposure, and bench testing to evaluate safety margin. Modeling estimated the incidence of a chronic change in pacing capture threshold >0.5 V and 1.0 V to be less than 1 in 160,000 and less than 1 in 1,000,000 cases, respectively. Modeling also estimated the incidence of unintended cardiac stimulation to occur in less than 1 in 1,000,000 cases. Animal studies demonstrated no delay in ventricular fibrillation detection and no reduction in ventricular fibrillation amplitude at clinical MRI exposure levels, even with multiple exposures. Bench and scanner testing demonstrated performance and safety against all other MRI-induced hazards. A preclinical strategy that includes comprehensive computer modeling, animal studies, and bench and scanner testing predicts that an ICD system developed for the magnetic resonance environment is safe and poses very low risks when exposed to 1.5-T normal operating mode whole-body MRI. Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

The subcutaneous implantable cardioverter defibrillator––review of the recent data

PubMed Central

Westerman, Stacy B; El-Chami, Mikhael

2018-01-01

The subcutaneous implantable cardioverter defibrillators (SICD) is an alternative to the transvenous ICD for the prevention of sudden cardiac death (SCD). Multiple studies have shown that the SICD is safe and effective in treating ventricular arrhythmias. While earlier studies mainly enrolled younger patients with channelopathies, more recent reports included patients with “typical” indications for ICD therapy for the prevention of SCD. In this review we summarize the data available to date on the SICD while highlighting its pros and cons. PMID:29721001

Safety of sports for athletes with implantable cardioverter-defibrillators: results of a prospective, multinational registry.

PubMed

Lampert, Rachel; Olshansky, Brian; Heidbuchel, Hein; Lawless, Christine; Saarel, Elizabeth; Ackerman, Michael; Calkins, Hugh; Estes, N A Mark; Link, Mark S; Maron, Barry J; Marcus, Frank; Scheinman, Melvin; Wilkoff, Bruce L; Zipes, Douglas P; Berul, Charles I; Cheng, Alan; Law, Ian; Loomis, Michele; Barth, Cheryl; Brandt, Cynthia; Dziura, James; Li, Fangyong; Cannom, David

2013-05-21

The risks of sports participation for implantable cardioverter-defibrillator (ICD) patients are unknown. Athletes with ICDs (age, 10-60 years) participating in organized (n=328) or high-risk (n=44) sports were recruited. Sports-related and clinical data were obtained by phone interview and medical records. Follow-up occurred every 6 months. ICD shock data and clinical outcomes were adjudicated by 2 electrophysiologists. Median age was 33 years (89 subjects <20 years of age); 33% were female. Sixty were competitive athletes (varsity/junior varsity/traveling team). A pre-ICD history of ventricular arrhythmia was present in 42%. Running, basketball, and soccer were the most common sports. Over a median 31-month (interquartile range, 21-46 months) follow-up, there were no occurrences of either primary end point-death or resuscitated arrest or arrhythmia- or shock-related injury-during sports. There were 49 shocks in 37 participants (10% of study population) during competition/practice, 39 shocks in 29 participants (8%) during other physical activity, and 33 shocks in 24 participants (6%) at rest. In 8 ventricular arrhythmia episodes (device defined), multiple shocks were received: 1 at rest, 4 during competition/practice, and 3 during other physical activity. Ultimately, the ICD terminated all episodes. Freedom from lead malfunction was 97% at 5 years (from implantation) and 90% at 10 years. Many athletes with ICDs can engage in vigorous and competitive sports without physical injury or failure to terminate the arrhythmia despite the occurrence of both inappropriate and appropriate shocks. These data provide a basis for more informed physician and patient decision making in terms of sports participation for athletes with ICDs.

Electromagnetic Interference in Implantable Defibrillators in Single-Engine Fixed-Wing Aircraft.

PubMed

de Rotte, Alexandra A J; van der Kemp, Peter; Mundy, Peter A; Rienks, Rienk; de Rotte, August A

2017-01-01

Little is known about the possible electromagnetic interferences (EMI) in the single-engine fixed-wing aircraft environment with implantable cardio-defibrillators (ICDs). Our hypothesis is that EMI in the cockpit of a single-engine fixed-wing aircraft does not result in erroneous detection of arrhythmias and the subsequent delivery of an inappropriate device therapy. ICD devices of four different manufacturers, incorporated in a thorax phantom, were transported in a Piper Dakota Aircraft with ICAO type designator P28B during several flights. The devices under test were programmed to the most sensitive settings for detection of electromagnetic signals from their environment. After the final flight the devices under test were interrogated with the dedicated programmers in order to analyze the number of tachycardias detected. Cumulative registration time of the devices under test was 11,392 min, with a mean of 2848 min per device. The registration from each one of the devices did not show any detectable "tachycardia" or subsequent inappropriate device therapy. This indicates that no external signals, which could be originating from electromagnetic fields from the aircraft's avionics, were detected by the devices under test. During transport in the cockpit of a single-engine fixed-wing aircraft, the tested ICDs did not show any signs of being affected by electromagnetic fields originating from the avionics of the aircraft. This current study indicates that EMI is not a potential safety issue for transportation of passengers with an ICD implanted in a single-engine fixed-wing aircraft.de Rotte AAJ, van der Kemp P, Mundy PA, Rienks R, de Rotte AA. Electromagnetic interference in implantable defibrillators in single-engine fixed-wing aircraft. Aerosp Med Hum Perform. 2017; 88(1):52-55.

Substance use and addictive disorders in DSM-5 and ICD 10 and the draft ICD 11.

PubMed

Saunders, John B

2017-07-01

The present review compares and contrasts the diagnostic entities and taxonomy of substance use and addictive disorders in the beta draft of the Eleventh Revision of the International Classification of Diseases (ICD 11), which was released in November 2016, and the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), which was published in mid-2013. Recently published papers relevant to these two classification systems are examined. New initiatives in diagnosis and assessment including the addictions neuroclinical assessment are noted. The draft ICD 11 retains substance dependence as the 'master diagnosis' in contrast to the broader and heterogeneous concept of substance use disorder in DSM-5 and there is empirical support for the coherence of substance dependence for alcohol, cannabis, and prescribed opioids. Both systems now include gambling disorder in the addictive disorders section, with it being transferred from the impulse control disorders section. The new diagnosis of Internet gaming disorder is included in DSM-5 as a condition for further study, and gaming disorder is grouped with the substance and gambling disorders in the draft ICD 11. Initiatives from the U.S. National Institutes of Health (NIH) are highlighting the importance of capturing the neurobiological phases of the addictive cycle in clinical diagnosis and assessment. Although most of the changes in the draft ICD 11 and DSM-5 are incremental, the contrast between DSM-5 substance use disorder and substance dependence in the draft ICD 11, and the inclusion of gambling disorder and gaming disorder will generate much discussion and research.

A scoping review of ICD-11 adjustment disorder research.

PubMed

Kazlauskas, Evaldas; Zelviene, Paulina; Lorenz, Louisa; Quero, Soledad; Maercker, Andreas

2017-01-01

Background : Adjustment disorder (AjD) is one of the most used mental disorder diagnoses among mental health professionals. Important revisions of the AjD definition in the 11th edition of the International Classification of Diseases (ICD-11) are proposed. AjD is included in a chapter of disorders specifically associated with stress in ICD-11. Objective : This paper aims to review recent developments in ICD-11 AjD research, and to discuss the available ICD-11 AjD diagnosis validation studies, AjD measures, treatment studies, and outline the future perspectives for AjD research and clinical practice. Methods : In total, 10 empirical studies of AjD ICD-11 were identified and included in this review. We searched for studies in Embase, PubMed, PsycINFO, Scopus, PILOTS, SocINDEX, and via additional search by contacting authors of published empirical studies and reference screening. Results : Review of the studies revealed a lack of validation studies of the ICD-11 AjD symptom structure. AjD validation study findings are ambiguous, and there is still little support for the proposed two symptom structure of AjD for the ICD-11. A self-report AjD measure 'Adjustment Disorder New Module' (ADNM) based on the ICD-11 definition has been developed and used in all 10 reviewed studies. Two self-help interventions have been developed for the ICD-11 AjD, and findings from these studies indicate that self-help low-intensity cognitive-behavioural interventions, delivered via bibliography or internet-based, might be effective treatment of AjD. Conclusions : The AjD definition in ICD-11 with a description of a new symptom profile facilitates AjD measurement and AjD-focused treatment developments. More studies and insights from clinical practice are needed to move the field of AjD research and practice forward.

Automatic identification of cochlear implant electrode arrays for post-operative assessment

NASA Astrophysics Data System (ADS)

Noble, Jack H.; Schuman, Theodore A.; Wright, Charles G.; Labadie, Robert F.; Dawant, Benoit M.

2011-03-01

Cochlear implantation is a procedure performed to treat profound hearing loss. Accurately determining the postoperative position of the implant in vivo would permit studying the correlations between implant position and hearing restoration. To solve this problem, we present an approach based on parametric Gradient Vector Flow snakes to segment the electrode array in post-operative CT. By combining this with existing methods for localizing intra-cochlear anatomy, we have developed a system that permits accurate assessment of the implant position in vivo. The system is validated using a set of seven temporal bone specimens. The algorithms were run on pre- and post-operative CTs of the specimens, and the results were compared to histological images. It was found that the position of the arrays observed in the histological images is in excellent agreement with the position of their automatically generated 3D reconstructions in the CT scans.

Intraoperative Defibrillation Testing of Subcutaneous Implantable Cardioverter-Defibrillator Systems-A Simple Issue?

PubMed

Frommeyer, Gerrit; Zumhagen, Sven; Dechering, Dirk G; Larbig, Robert; Bettin, Markus; Löher, Andreas; Köbe, Julia; Reinke, Florian; Eckardt, Lars

2016-03-15

The results of the recently published randomized SIMPLE trial question the role of routine intraoperative defibrillation testing. However, testing is still recommended during implantation of the entirely subcutaneous implantable cardioverter-defibrillator (S-ICD) system. To address the question of whether defibrillation testing in S-ICD systems is still necessary, we analyzed the data of a large, standard-of-care prospective single-center S-ICD registry. In the present study, 102 consecutive patients received an S-ICD for primary (n=50) or secondary prevention (n=52). Defibrillation testing was performed in all except 4 patients. In 74 (75%; 95% CI 0.66-0.83) of 98 patients, ventricular fibrillation was effectively terminated by the first programmed internal shock. In 24 (25%; 95% CI 0.22-0.44) of 98 patients, the first internal shock was ineffective and further internal or external shock deliveries were required. In these patients, programming to reversed shock polarity (n=14) or repositioning of the sensing lead (n=1) or the pulse generator (n=5) led to successful defibrillation. In 4 patients, a safety margin of <10 J was not attained. Nevertheless, in these 4 patients, ventricular arrhythmias were effectively terminated with an internal 80-J shock. Although it has been shown that defibrillation testing is not necessary in transvenous ICD systems, it seems particular important for S-ICD systems, because in nearly 25% of the cases the primary intraoperative test was not successful. In most cases, a successful defibrillation could be achieved by changing shock polarity or by optimizing the shock vector caused by the pulse generator or lead repositioning. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Telemedicine and cardiac implants: what is the benefit?

PubMed Central

Varma, Niraj; Ricci, Renato Pietro

2013-01-01

Cardiac implantable electronic devices are increasing in prevalence. The post-implant follow-up is important for monitoring both device function and patient condition. However, practice is inconsistent. For example, ICD follow-up schedules vary from 3 monthly to yearly according to facility and physician preference and availability of resources. Recommended follow-up schedules impose significant burden. Importantly, no surveillance occurs between follow-up visits. In contrast, implantable devices with automatic remote monitoring capability provide a means for performing constant surveillance, with the ability to identify salient problems rapidly. Remote home monitoring reduces the volume of device clinic visits and provides early detection of patient and/or system problems. PMID:23211231

Towards eradication of inappropriate therapies for ICD lead failure by combining comprehensive remote monitoring and lead noise alerts.

PubMed

Ploux, Sylvain; Swerdlow, Charles D; Strik, Marc; Welte, Nicolas; Klotz, Nicolas; Ritter, Philippe; Haïssaguerre, Michel; Bordachar, Pierre

2018-06-02

Recognition of implantable cardioverter defibrillator (ICD) lead malfunction before occurrence of life threatening complications is crucial. We aimed to assess the effectiveness of remote monitoring associated or not with a lead noise alert for early detection of ICD lead failure. From October 2013 to April 2017, a median of 1,224 (578-1,958) ICD patients were remotely monitored with comprehensive analysis of all transmitted materials. ICD lead failure and subsequent device interventions were prospectively collected in patients with (RMLN) and without (RM) a lead noise alert (Abbott Secure Sense™ or Medtronic Lead Integrity Alert™) in their remote monitoring system. During a follow-up of 4,457 patient years, 64 lead failures were diagnosed. Sixty-one (95%) of the diagnoses were made before any clinical complication occurred. Inappropriate shocks were delivered in only one patient of each group (3%), with an annual rate of 0.04%. All high voltage conductor failures were identified remotely by a dedicated impedance alert in 10 patients. Pace-sense component failures were correctly identified by a dedicated alert in 77% (17 of 22) of the RMLN group versus 25% (8 of 32) of the RM group (P = 0.002). The absence of a lead noise alert was associated with a 16-fold increase in the likelihood of initiating either a shock or ATP (OR: 16.0, 95% CI 1.8-143.3; P = 0.01). ICD remote monitoring with systematic review of all transmitted data is associated with a very low rate of inappropriate shocks related to lead failure. Dedicated noise alerts further reduce inappropriate detection of ventricular arrhythmias. © 2018 Wiley Periodicals, Inc.

Minimally invasive epicardial implantable cardioverter-defibrillator placement for infants and children: An effective alternative to the transvenous approach.

PubMed

Schneider, Andrew E; Burkhart, Harold M; Ackerman, Michael J; Dearani, Joseph A; Wackel, Philip; Cannon, Bryan C

2016-09-01

Young patients have high rates of implantable cardioverter-defibrillator (ICD) lead fractures and are at risk for venous occlusion or tricuspid regurgitation with transvenous lead placement. Epicardial ICDs have the potential to circumvent complications associated with transvenous ICDs, but the literature on young patients remains limited. The purpose of this study was to evaluate the results of a minimally invasive epicardial ICD lead placement approach in young patients. A retrospective, institutional review board-approved electronic medical record review of all patients undergoing epicardial ICD placement at our institution from January 2011 to December 2015 was performed. A total of 46 patients (20 female [43%]; mean age 10.3 years, range 0.7-18.2 years; mean weight 41 ± 21 kg) were identified; 24 (52%) were ≤10 years old. A minithoracotomy was used in 28 patients (61%). All had acceptable defibrillation, right ventricular sensing, and stimulation thresholds. Median follow-up was 2.0 ± 1.3 years (range 0.02-4.5 years). Eight surgical complications occurred in 7 patients (15%), and 8 device-related complications occurred in 6 patients (13%). Fifty-eight appropriate shocks were delivered in 7 patients (15%). Four patients received inappropriate shocks in relation to lead fractures/microfractures. One patient in this cohort who had long QT syndrome type 8 died of a hypoglycemic seizure. Minimally invasive epicardial ICD placement provides an effective, alternative method for implanting an ICD system, particularly in very young patients (<6 years of age) or patients who are concerned about cosmetic appearance. This technique is an acceptable alternative to traditional transvenous ICD placement. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Laparoscopic Adjustable Gastric Band Explantation and Implantation at Academic Centers.

PubMed

Koh, Christina Y; Inaba, Colette S; Sujatha-Bhaskar, Sarath; Hohmann, Samuel; Ponce, Jaime; Nguyen, Ninh T

2017-10-01

The laparoscopic adjustable gastric band (LAGB) was approved for use in the US in 2001 and has been found to be a safe and effective surgical treatment for morbid obesity. However, there is a recent trend toward reduced use of LAGB nationwide. The objective of this study was to examine the prevalence and outcomes of primary LAGB implantation compared with revision and explantation at academic centers. Data were obtained from the Vizient database from 2007 through 2015. The ICD-9-Clinical Modification and ICD-10-Clinical Modification were used to select patients with a primary diagnosis of obesity who had undergone LAGB implantation, revision, or explantation. Prevalence and outcomes of primary LAGB implantation compared with revision or explantation were analyzed. Outcomes measures included length of stay, ICU admission, morbidity, mortality, and cost. From 2007 through 2015, a total of 28,202 patients underwent LAGB implantation for surgical weight loss. The annual number of LAGB implantation procedures decreased steadily after 2010. In the same time period, 12,157 patients underwent LAGB explantation. In 2013, the number of LAGB explantation procedures exceeded that of implantation. Laparoscopic adjustable gastric band revision rates remained stable throughout the study period. Mean length of stay, serious morbidity, and proportion of patients requiring ICU admission were higher for gastric band revision and explantation cases compared with primary LAGB implantation cases. There was no statistically significant difference in mortality or mean cost between the 2 groups. Since 2013, the number of gastric band explantation procedures has exceeded that of implantation procedures at academic centers. Laparoscopic adjustable gastric band revision or explantation is associated with longer length of stay, higher rate of postoperative ICU admissions, and higher overall morbidity compared with LAGB implantation. Copyright © 2017 American College of Surgeons. Published by

Readability and Content of Patient Education Material Related to Implantable Cardioverter Defibrillators

PubMed Central

Strachan, Patricia H.; de Laat, Sonya; Carroll, Sandra L.; Schwartz, Lisa; Vaandering, Katie; Toor, Gurjit K.; Arthur, Heather M.

2012-01-01

Background Implantable cardioverter defibrillators (ICDs) are increasingly offered to patients for primary prevention of sudden cardiac death. Candidates for ICD receive ICD-related patient education material when they make decisions to consent or decline a primary prevention ICD. Printed patient education material directed at ICD candidates has not been the focus of direct appraisal. Objective We evaluated the readability and content of ICD-related print education materials made available to patients who were enrolled in a study involving patient decision making for ICD from 3 ICD sites in southern Ontario, Canada. Methods All ICD print materials referred to during interviews and/or that were available in ICD site waiting rooms were collected for analysis. Readability testing was conducted using the SMOG (“simple measurement of gobbledygook”) and Fry methods. The material was evaluated according to selected plain-language criteria, thematic content analysis, and rhetoric analysis. Results Twenty-one print materials were identified and analyzed. Documents were authored by device manufacturers, tertiary care hospitals, and cardiac support organizations. Although many documents adhered to plain-language recommendations, text-reading levels were higher than recommended. Twelve major content themes were identified. Content focused heavily on the positive aspects of living with the device to the exclusion of other possible information that could be relevant to the decisions that patients made. Conclusions Print-based patient education materials for ICD candidates are geared to a highly literate population. The focus on positive information to the exclusion of potentially negative aspects of the ICD, or alternatives to accepting 1, could influence and/or confuse patients about the purpose and implications of this medical device. Development of print materials is indicated that includes information about possible problems and that would be relevant for the

Dollars and sense: Mitigating budget risk for ICD-10.

PubMed

Newell, Lucy Mancini; DeSilva, Joseph J

2013-02-01

The extended deadline for ICD-10 implementation is time that should not be wasted. Healthcare leaders should keep three things in mind: CFOs should approach the effort knowing the costs of ICD-10 implementation will be high and spread over multiple budget years. Training, productivity, and contractual issues are among key areas that will be challenged by ICD-10 implementation. Healthcare finance leaders should work to improve cash-on-hand and cash reserves prior to the ICD-10 deadline to ensure liquidity post-compliance.

Implantable cardioverter defibrillator use for primary prevention in ischaemic and non-ischaemic heart disease-indications in the post-DANISH trial era: results of the European Heart Rhythm Association survey.

PubMed

Haugaa, Kristina H; Tilz, Roland; Boveda, Serge; Dobreanu, Dan; Sciaraffia, Elena; Mansourati, Jacques; Papiashvili, Giorgi; Dagres, Nikolaos

2017-04-01

Implantable cardioverter-defibrillator (ICD) is the standard of care for prevention of sudden cardiac death (SCD) in high-risk patients. For primary prevention of SCD, in patients with ischaemic heart disease, there is more robust data on the effect of ICD therapy compared with patients with non-ischaemic heart disease, but current real-life practice may differ substantially. The aim of this European Heart Rhythm Association survey was to evaluate the clinical practice regarding implantation of ICD for primary prevention among European countries in patients with non-ischaemic and ischaemic heart disease. Furthermore, we wanted to investigate the impact of the results of the recently published DANISH trial on clinical practice among European countries. In total, 48 centres from 17 different countries responded to the questionnaire. The majority did not implant ICD for primary prevention on a regular basis in patients with non-ischaemic heart disease despite current guidelines. Also, centres have changed their indications after the recent report on the efficacy of ICD in these patients. In patients with ischaemic heart disease, the guidelines for primary prevention ICD were followed on a regular basis, and no relevant change in indications were reported. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.

Efficacy and safety of the subcutaneous implantable cardioverter defibrillator: a systematic review.

PubMed

Chue, Colin Dominic; Kwok, Chun Shing; Wong, Chun Wai; Patwala, Ashish; Barker, Diane; Zaidi, Amir; Mamas, Mamas A; Cunnington, Colin; Ahmed, Fozia Z

2017-09-01

Subcutaneous implantable cardioverter defibrillators (S-ICDs) are considered an alternative to conventional transvenous ICDs (TV-ICDs) in patients not requiring pacing. We searched MEDLINE and EMBASE for studies evaluating efficacy and safety outcomes in S-ICD patients. Outcomes were pooled across studies. Sixteen studies were included with 5380 participants (mean age range 33-56 years). Short-term follow-up data were available for 1670 subjects. The most common complication was pocket infection, affecting 2.7%. Other complications included delayed wound healing (0.6%) and wound discomfort (0.8%). 3.8% of S-ICDs were explanted, most commonly for pocket infection. Mortality rates in hospital (0.4%) and during follow-up (3.4% from 12 studies reporting) were low. Incidence of ventricular arrhythmia varied from 0% to 12%. Overall shock efficacy exceeded 96%. Inappropriate shocks affected 4.3% and was most commonly caused by T-wave oversensing. Although long-term randomised data are lacking, observational data suggest similar shock efficacy and short-term complication rates between the S-ICD and TV-ICD. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Association Between Prophylactic Implantable Cardioverter-Defibrillators and Survival in Patients With Left Ventricular Ejection Fraction Between 30% and 35%

PubMed Central

Al-Khatib, Sana M.; Hellkamp, Anne S.; Fonarow, Gregg C.; Mark, Daniel B.; Curtis, Lesley H.; Hernandez, Adrian F.; Anstrom, Kevin J.; Peterson, Eric D.; Sanders, Gillian D.; Al-Khalidi, Hussein R.; Hammill, Bradley G.; Heidenreich, Paul A.; Hammill, Stephen C.

2014-01-01

IMPORTANCE Clinical trials of prophylactic implantable cardioverter-defibrillators (ICDs) have included a minority of patients with a left ventricular ejection fraction (LVEF) between 30% and 35%. Because a large number of ICDs in the United States are implanted in such patients, it is important to study survival associated with this therapy. OBJECTIVE To characterize patients with LVEF between 30% and 35% and compare the survival of those with and without ICDs. DESIGN, SETTING, AND PARTICIPANTS Retrospective cohort study of Medicare beneficiaries in the National Cardiovascular Data Registry ICD registry (January 1, 2006, through December 31, 2007) with an LVEF between 30% and 35% who received an ICD during a heart failure hospitalization and similar patients in the Get With The Guidelines–Heart Failure (GWTG-HF) database (January 1, 2005, through December 31, 2009) with no ICD. The analysis was repeated in patients with an LVEF less than 30%. There were 3120 patients with an LVEF between 30% and 35% (816 in matched cohorts) and 4578 with an LVEF less than 30% (2176 in matched cohorts). Propensity score matching and Cox models were applied. MAIN OUTCOMES AND MEASURES The primary outcome was all-cause mortality; data were obtained from Medicare claims through December 31, 2011. RESULTS There were no significant differences in the baseline characteristics of the matched groups (n = 408 for both groups). Among patients with an LVEF between 30% and 35%, there were 248 deaths in the ICD Registry group, within a median follow-up of 4.4 years (interquartile range, 2.7-4.9) and 249 deaths in the GWTG HF group, within a median follow-up of 2.9 years (interquartile range, 2.1-4.4). The risk of all-cause mortality in patients with an LVEF between 30% and 35% and an ICD was significantly lower than that in matched patients without an ICD (3-year mortality rates: 51.4% vs 55.0%; hazard ratio, 0.83 [95% CI, 0.69-0.99]; P = .04). Presence of an ICD also was associated with

Modern Pacemaker and Implantable Cardioverter/Defibrillator Systems Can Be Magnetic Resonance Imaging Safe

PubMed Central

Roguin, Ariel; Zviman, Menekhem M.; Meininger, Glenn R.; Rodrigues, E. Rene; Dickfeld, Timm M.; Bluemke, David A.; Lardo, Albert; Berger, Ronald D.; Calkins, Hugh; Halperin, Henry R.

2011-01-01

Background MRI has unparalleled soft-tissue imaging capabilities. The presence of devices such as pacemakers and implantable cardioverter/defibrillators (ICDs), however, is historically considered a contraindication to MRI. These devices are now smaller, with less magnetic material and improved electromagnetic interference protection. Our aim was to determine whether these modern systems can be used in an MR environment. Methods and Results We tested in vitro and in vivo lead heating, device function, force acting on the device, and image distortion at 1.5 T. Clinical MR protocols and in vivo measurements yielded temperature changes <0.5°C. Older (manufactured before 2000) ICDs were damaged by the MR scans. Newer ICD systems and most pacemakers, however, were not. The maximal force acting on newer devices was <100 g. Modern (manufactured after 2000) ICD systems were implanted in dogs (n=18), and after 4 weeks, 3- to 4-hour MR scans were performed (n=15). No device dysfunction occurred. The images were of high quality with distortion dependent on the scan sequence and plane. Pacing threshold and intracardiac electrogram amplitude were unchanged over the 8 weeks, except in 1 animal that, after MRI, had a transient (<12 hours) capture failure. Pathological data of the scanned animals revealed very limited necrosis or fibrosis at the tip of the lead area, which was not different from controls (n=3) not subjected to MRI. Conclusions These data suggest that certain modern pacemaker and ICD systems may indeed be MRI safe. This may have major clinical implications for current imaging practices. PMID:15277324

Implantable Cardioverter Defibrillator Programming Characteristics, Shocked Rhythms, and Survival Among Patients Under Thirty Years of Age.

PubMed

Chang, Philip M; Powell, Brian D; Jones, Paul W; Carter, Nathan; Hayes, David L; Saxon, Leslie A

2016-10-01

Indications for implantable cardioverter defibrillators (ICDs) in young patients have expanded and differ from those in older adults. We sought to provide descriptive characteristics and data regarding ICD therapy and outcomes among younger and older ICD recipients. Demographics, device type and programming, remotely transmitted data, shock events, and survival were compared among younger (≤30 years) and older (>30 years) cohorts with ICDs from a single manufacturer followed on a remote network. The younger cohort included 904 patients (1.6% of all implants). This group had more females (46% vs. 25%; P < 0.01), single-coil leads (21% vs. 4%; P < 0.01), and single-chamber devices (46% vs. 34%; P < 0.01). Shock incidence was higher (40% younger vs. 32% older at 4 years; P < 0.01) and survival was better over comparable follow-up (88% vs. 72%; P < 0.01). Remote monitoring was associated with improved survival in both groups (93% vs. 86% ≤ 30 years, P < 0.01; 73% vs. 66% > 30 years, P < 0.01). Shock for polymorphic ventricular tachycardia/fibrillation (VT/VF) was more frequent in younger patients (12% vs. 5%; P < 0.01); 39% of all shocks were inappropriate. A 10-fold increased risk of mortality was seen among young patients with shocks for atrial fibrillation/flutter (AF/AFL). Differences in survival, shock incidence, and prognostic significance of VT/VF and AF/AFL exist between younger and older ICD recipients. These suggest distinct differences in myocardial substrates and diseases that ultimately impact ICD management. © 2016 Wiley Periodicals, Inc.

Implantable cardioverter defibrillators for primary prevention of death in left ventricular dysfunction with and without ischaemic heart disease: a meta-analysis of 8567 patients in the 11 trials.

PubMed

Shun-Shin, Matthew J; Zheng, Sean L; Cole, Graham D; Howard, James P; Whinnett, Zachary I; Francis, Darrel P

2017-06-07

Primary prevention implantable cardioverter defibrillators (ICDs) are established therapy for reducing mortality in patients with left ventricular systolic dysfunction and ischaemic heart disease (IHD). However, their efficacy in patients without IHD has been controversial. We undertook a meta-analysis of the totality of the evidence. We systematically identified all RCTs comparing ICD vs. no ICD in primary prevention. Eligible RCTs were those that recruited patients with left ventricular dysfunction, reported all-cause mortality, and presented their results stratified by the presence of IHD (or recruited only those with or without). Our primary endpoint was all-cause mortality. We identified 11 studies enrolling 8567 participants with left ventricular dysfunction, including 3128 patients without IHD and 5439 patients with IHD. In patients without IHD, ICD therapy reduced mortality by 24% (HR 0.76, 95% CI 0.64 to 0.90, P = 0.001). In patients with IHD, ICD implantation (at a dedicated procedure), also reduced mortality by 24% (HR 0.76, 95% CI 0.60 to 0.96, P = 0.02). Until now, it has never been explicitly stated that the patients without IHD in COMPANION showed significant survival benefit from adding ICD therapy (to a background of CRT). Even before DANISH, meta-analysis of patients without ischaemic heart disease already showed reduced mortality. DANISH is consistent with these data. With a significant 24% mortality reduction in both aetiologies, it may no longer be necessary to distinguish between them when deciding on primary prevention ICD implantation. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Cardiology.

Predicting trauma patient mortality: ICD [or ICD-10-AM] versus AIS based approaches.

PubMed

Willis, Cameron D; Gabbe, Belinda J; Jolley, Damien; Harrison, James E; Cameron, Peter A

2010-11-01

The International Classification of Diseases Injury Severity Score (ICISS) has been proposed as an International Classification of Diseases (ICD)-10-based alternative to mortality prediction tools that use Abbreviated Injury Scale (AIS) data, including the Trauma and Injury Severity Score (TRISS). To date, studies have not examined the performance of ICISS using Australian trauma registry data. This study aimed to compare the performance of ICISS with other mortality prediction tools in an Australian trauma registry. This was a retrospective review of prospectively collected data from the Victorian State Trauma Registry. A training dataset was created for model development and a validation dataset for evaluation. The multiplicative ICISS model was compared with a worst injury ICISS approach, Victorian TRISS (V-TRISS, using local coefficients), maximum AIS severity and a multivariable model including ICD-10-AM codes as predictors. Models were investigated for discrimination (C-statistic) and calibration (Hosmer-Lemeshow statistic). The multivariable approach had the highest level of discrimination (C-statistic 0.90) and calibration (H-L 7.65, P= 0.468). Worst injury ICISS, V-TRISS and maximum AIS had similar performance. The multiplicative ICISS produced the lowest level of discrimination (C-statistic 0.80) and poorest calibration (H-L 50.23, P < 0.001). The performance of ICISS may be affected by the data used to develop estimates, the ICD version employed, the methods for deriving estimates and the inclusion of covariates. In this analysis, a multivariable approach using ICD-10-AM codes was the best-performing method. A multivariable ICISS approach may therefore be a useful alternative to AIS-based methods and may have comparable predictive performance to locally derived TRISS models. © 2010 The Authors. ANZ Journal of Surgery © 2010 Royal Australasian College of Surgeons.

76 FR 51985 - ICD-9-CM Coordination and Maintenance Committee Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-19

... and Public Health Data Standards Staff, announces the following meeting. Name: ICD-9-CM Coordination.... 2012 ICD-10-PCS GEM and Reimbursement Map Updates. ICD-10-PCS Official Coding Guidelines. ICD-10 MS... Pickett, Medical Systems Administrator, Classifications and Public Health Data Standards Staff, NCHS, 3311...

Far-Infrared Emission of Intracluster Dust (ICD)

NASA Astrophysics Data System (ADS)

Arimoto, N.; Takagi, T.; Hanami, H.

2000-12-01

In the young universe, clusters of galaxies could be bright FIR-Submm sources due to the dust emissions from young ellipticals. The intracluster dust (ICD) could also contribute to the FIR-Submm emissions considerably, but the ICD is fragile in the ambient hot ICM. Therefore, a chance to detect the ICD emission would be much smaller than the dust emissions from galaxies. Dust emissions from elliptical galaxies (EROs) in the young Coma cluster at a distance of z=2-3 would be easily detected by a future mission of H2L2 satellite, thus the FIR-Submm survey would become a powerful tool for searching high-z clusters.

Application and comparison of the FADES, MADIT, and SHFM-D risk models for risk stratification of prophylactic implantable cardioverter-defibrillator treatment

PubMed Central

van der Heijden, Aafke C.; van Rees, Johannes B.; Levy, Wayne C.; van der Bom, Johanna G.; Cannegieter, Suzanne C.; de Bie, Mihàly K.; van Erven, Lieselot; Schalij, Martin J.; Borleffs, C. Jan  Willem

2017-01-01

Aims Implantable cardioverter-defibrillator (ICD) treatment is beneficial in selected patients. However, it remains difficult to accurately predict which patients benefit most from ICD implantation. For this purpose, different risk models have been developed. The aim was to validate and compare the FADES, MADIT, and SHFM-D models. Methods and results All patients receiving a prophylactic ICD at the Leiden University Medical Center were evaluated. Individual model performance was evaluated by C-statistics. Model performances were compared using net reclassification improvement (NRI) and integrated differentiation improvement (IDI). The primary endpoint was non-benefit of ICD treatment, defined as mortality without prior ventricular arrhythmias requiring ICD intervention. A total of 1969 patients were included (age 63 ± 11 years; 79% male). During a median follow-up of 4.5 ± 3.9 years, 318 (16%) patients died without prior ICD intervention. All three risk models were predictive for event-free mortality (all: P < 0.001). The C-statistics were 0.66, 0.69, and 0.75, respectively, for FADES, MADIT, and SHFM-D (all: P < 0.001). Application of the SHFM-D resulted in an improved IDI of 4% and NRI of 26% compared with MADIT; IDI improved 11% with the use of SHFM-D instead of FADES (all: P < 0.001), but NRI remained unchanged (P = 0.71). Patients in the highest-risk category of the MADIT and SHFM-D models had 1.7 times higher risk to experience ICD non-benefit than receive appropriate ICD interventions [MADIT: mean difference (MD) 20% (95% CI: 7–33%), P = 0.001; SHFM-D: MD 16% (95% CI: 5–27%), P = 0.005]. Patients in the highest-risk category of FADES were as likely to experience ICD intervention as ICD non-benefit [MD 3% (95% CI: –8 to 14%), P = 0.60]. Conclusion The predictive and discriminatory value of SHFM-D to predict non-benefit of ICD treatment is superior to FADES and MADIT in patients receiving prophylactic ICD treatment. PMID:28130376

Long-Term Survival With Implantable Cardioverter-Defibrillator in Different Symptomatic Functional Classes of Heart Failure.

PubMed

Biton, Yitschak; Rosero, Spencer; Moss, Arthur; Zareba, Wojciech; Kutyifa, Valentina; Baman, Jayson; Barsheshet, Alon; McNitt, Scott; Polonsky, Bronislava; Goldenberg, Ilan

2018-03-01

The ACC/AHA/HRS (American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society) guidelines recommend implantable cardioverter-defibrillator (ICD) therapy primary prevention in all patients with severely reduced left ventricular ejection fraction (≤30%) regardless of New York Heart Association (NYHA) functional class, whereas recent European guidelines limit the indication to those with symptomatic heart failure (NYHA ≥ II). We therefore aimed to evaluate the long-term survival benefit of primary ICD therapy among postmyocardial infarction patients with and without heart failure (HF) symptoms who were enrolled in MADIT-II (Multicenter Automatic Defibrillator Implantation Trial II). We classified 1,164 MADIT-II patient groups according to the baseline NYHA class (NYHA I [n = 442], NYHA II [n = 425], and NYHA III [n = 297]); patients with NYHA IV were excluded. Multivariate Cox proportional hazards regression modeling was performed to compare the mortality reduction with ICD versus non-ICD therapy during 8 years of follow-up between the 3 NYHA groups. The median (interquartile range) follow-up time was 7.6 (3.5 to 9) years. At 8 years of follow-up, the cumulative probability of mortality in the non-ICD treatment arm was 57% for NYHA I, 57% for NYHA II, and 76% for NYHA III (p <0.001). Multivariate models demonstrated similar long-term mortality risk reduction with ICD compared with the non-ICD treatment arm regardless of HF symptoms: NYHA I (HR = 0.63, 0.46 to 0.85, p = 0.003), NYHA II (HR = 0.68, 0.50 to 0.93, p = 0.017), and NYHA III (HR = 0.68, 0.50 to 0.94, p = 0.018); p for NYHA class by treatment arm interaction >0.10. In conclusion, primary ICD therapy provides consistent long-term survival benefit among patients with previous myocardial infarction and severe left ventricular dysfunction, regardless of HF symptoms. Copyright © 2017 Elsevier Inc

Hypochondriasis: considerations for ICD-11.

PubMed

van den Heuvel, Odile A; Veale, David; Stein, Dan J

2014-01-01

The World Health Organization (WHO) is currently revisiting the ICD. In the 10th version of the ICD, approved in 1990, hypochondriacal symptoms are described in the context of both the primary condition hypochondriacal disorder and as secondary symptoms within a range of other mental disorders. Expansion of the research base since 1990 makes a critical evaluation and revision of both the definition and classification of hypochondriacal disorder timely. This article addresses the considerations reviewed by members of the WHO ICD-11 Working Group on the Classification of Obsessive-Compulsive and Related Disorders in their proposal for the description and classification of hypochondriasis. The proposed revision emphasizes the phenomenological overlap with both anxiety disorders (e.g., fear, hypervigilance to bodily symptoms, and avoidance) and obsessive-compulsive and related disorders (e.g., preoccupation and repetitive behaviors) and the distinction from the somatoform disorders (presence of somatic symptom is not a critical characteristic). This revision aims to improve clinical utility by enabling better recognition and treatment of patients with hypochondriasis within the broad range of global health care settings.

Device orientation of a leadless pacemaker and subcutaneous implantable cardioverter-defibrillator in canine and human subjects and the effect on intrabody communication.

PubMed

Quast, Anne-Floor B E; Tjong, Fleur V Y; Koop, Brendan E; Wilde, Arthur A M; Knops, Reinoud E; Burke, Martin C

2018-02-14

The development of communicating modular cardiac rhythm management systems relies on effective intrabody communication between a subcutaneous implantable cardioverter-defibrillator (S-ICD) and a leadless pacemaker (LP), using conducted communication. Communication success is affected by the LP and S-ICD orientation. This study is designed to evaluate the orientation of the LP and S-ICD in canine subjects and measure success and threshold of intrabody communication. To gain more human insights, we will explore device orientation in LP and S-ICD patients. Canine subjects implanted with a prototype S-ICD and LP (both Boston Scientific, MA, USA) with anterior-posterior fluoroscopy images were included in this analysis. For comparison, a retrospective analysis of human S-ICD and LP patients was performed. The angle of the long axis of the LP towards the vertical axis of 0°, and distance between the coil and LP were measured. Twenty-three canine subjects were analysed. Median angle of the LP was 29° and median distance of the S-ICD coil to LP was 0.8 cm. All canine subjects had successful communication. The median communicating threshold was 2.5 V. In the human retrospective analysis, 72 LP patients and 100 S-ICD patients were included. The mean angle of the LP was 56° and the median distance between the S-ICD coil and LP was 4.6 cm. Despite the less favourable LP orientation in canine subjects, all communication attempts were successful. In the human subjects, we observed a greater and in theory more favourable LP angle towards the communication vector. These data suggests suitability of human anatomy for conductive intrabody communication.

An automated, web-enabled and searchable database system for archiving electrogram and related data from implantable cardioverter defibrillators.

PubMed

Zong, W; Wang, P; Leung, B; Moody, G B; Mark, R G

2002-01-01

The advent of implantable cardioverter defibrillators (ICDs) has resulted in significant reductions in mortality in patients at high risk for sudden cardiac death. Extensive related basic research and clinical investigation continue. ICDs typically record intracardiac electrograms and inter-beat intervals along with device settings during episodes of device delivery of therapy. Researchers wishing to study these data further have until now been limited to viewing paper plots. In support of multi-center clinical studies of patients with ICDs, we have developed a web based searchable ICD data archiving system, which allows users to use a web browser to upload ICD data from diskettes to a server where the data are automatically processed and archived. Users can view and download the archived ICD data directly via the web. The entire system is built from open source software. At present more than 500 patient ICD data sets have been uploaded to and archived in the system. This project will be of value not only to those who wish to conduct research using ICD data, but also to clinicians who need to archive and review ICD data collected from their patients.

Implementation and impact of ICD-10 (Part II)

PubMed Central

Rahmathulla, Gazanfar; Deen, H. Gordon; Dokken, Judith A.; Pirris, Stephen M.; Pichelmann, Mark A.; Nottmeier, Eric W.; Reimer, Ronald; Wharen, Robert E.

2014-01-01

Background: The transition from the International Classification of Disease-9th clinical modification to the new ICD-10 was all set to occur on 1 October 2015. The American Medical Association has previously been successful in delaying the transition by over 10 years and has been able to further postpone its introduction to 2015. The new system will overcome many of the limitations present in the older version, thus paving the way to more accurate capture of clinical information. Methods: The benefits of the new ICD-10 system include improved quality of care, potential cost savings, reduction of unpaid claims, and improved tracking of healthcare data. The areas where challenges will be evident include planning and implementation, the cost to transition, a shortage of qualified coders, training and education of the healthcare workforce, and a loss of productivity when this occurs. The impacts include substantial costs to the healthcare system, but the projected long-term savings and benefits will be significant. Improved fraud detection, accurate data entry, ability to analyze cost benefits with procedures, and enhanced quality outcome measures are the most significant beneficial factors with this change. Results: The present Current Procedural Terminology and Healthcare Common Procedure Coding System code sets will be used for reporting ambulatory procedures in the same manner as they have been. ICD-10-PCS will replace ICD-9 procedure codes for inpatient hospital services. The ICD-10-CM will replace the clinical code sets. Our article will focus on the challenges to execution of an ICD change and strategies to minimize risk while transitioning to the new system. Conclusion: With the implementation deadline gradually approaching, spine surgery practices that include multidisciplinary health specialists have to anticipate and prepare for the ICD change in order to mitigate risk. Education and communication is the key to this process in spine practices. PMID:25184098

Implementation and impact of ICD-10 (Part II).

PubMed

Rahmathulla, Gazanfar; Deen, H Gordon; Dokken, Judith A; Pirris, Stephen M; Pichelmann, Mark A; Nottmeier, Eric W; Reimer, Ronald; Wharen, Robert E

2014-01-01

The transition from the International Classification of Disease-9(th) clinical modification to the new ICD-10 was all set to occur on 1 October 2015. The American Medical Association has previously been successful in delaying the transition by over 10 years and has been able to further postpone its introduction to 2015. The new system will overcome many of the limitations present in the older version, thus paving the way to more accurate capture of clinical information. The benefits of the new ICD-10 system include improved quality of care, potential cost savings, reduction of unpaid claims, and improved tracking of healthcare data. The areas where challenges will be evident include planning and implementation, the cost to transition, a shortage of qualified coders, training and education of the healthcare workforce, and a loss of productivity when this occurs. The impacts include substantial costs to the healthcare system, but the projected long-term savings and benefits will be significant. Improved fraud detection, accurate data entry, ability to analyze cost benefits with procedures, and enhanced quality outcome measures are the most significant beneficial factors with this change. The present Current Procedural Terminology and Healthcare Common Procedure Coding System code sets will be used for reporting ambulatory procedures in the same manner as they have been. ICD-10-PCS will replace ICD-9 procedure codes for inpatient hospital services. The ICD-10-CM will replace the clinical code sets. Our article will focus on the challenges to execution of an ICD change and strategies to minimize risk while transitioning to the new system. With the implementation deadline gradually approaching, spine surgery practices that include multidisciplinary health specialists have to anticipate and prepare for the ICD change in order to mitigate risk. Education and communication is the key to this process in spine practices.

Estimating the Risks and Benefits of Implantable Cardioverter Defibrillator Generator Replacement: A Systematic Review.

PubMed

Lewis, Krystina B; Stacey, Dawn; Carroll, Sandra L; Boland, Laura; Sikora, Lindsey; Birnie, David

2016-07-01

Every 4-7 years an implantable cardioverter defibrillator (ICD) pulse generator must be replaced surgically. This procedure is not without risk. In some cases, the risk versus benefit ratio may be against replacement. We aimed to synthesize the evidence on risks, benefits, and costs related to ICD replacement. A systematic review was conducted using electronic databases from 2000 onward. Literature screening, quality appraisal, and data extraction were independently conducted by two reviewers. Outcomes included major and minor complications, ICD therapies, and costs, which were synthesized descriptively. Of 1,483 citations, 17 nonrandomized studies met criteria. Median rate of major complications was 4.05% (range 0.55-7.37%) and minor complications was 3.50% (range 0.36-7.37%). Without non-ICD control groups, the true risk reduction provided by the ICD following replacement is unknown. Following ICD replacement, annualized rate of appropriate ICD therapy was 10.52% (range 2.42-75.00%). Of these, patients without therapies during their first generator life and those no longer meeting ICD criteria received appropriate therapies at nontrivial rates. Rates of complications associated with ICD replacement are substantial. No study had nonreplacement groups, hence the true risk reduction provided by the ICD following replacement is unknown. Our analysis did not identify a subgroup at low risk of therapies following replacement. Shared discussions should occur with patients about the evidence, healthcare goals, risk tolerances, and feelings about life and death trade-offs to enable high-quality decisions about ICD replacement. ©2016 Wiley Periodicals, Inc.

Enhanced risk profiling of implanted defibrillator shocks with circulating SCN5A mRNA splicing variants: a pilot trial

PubMed Central

Gao, Ge; Brahmanandam, Vikram; Raicu, Mihai; Gu, Lianzhi; Zhou, Li; Kasturirangan, Srinivasan; Shah, Anish; Negi, Smita I.; Wood, Melissa R.; Desai, Ankit A.; Tatooles, Antone; Schwartz, Alan; Dudley, Samuel C.

2014-01-01

Objectives The aim of this study was to determine the association of SCN5A cardiac sodium (Na+) channel mRNA splice variants in white blood cells (WBCs) with risk of arrhythmias in heart failure (HF). Background HF is associated with upregulation of two cardiac SCN5A mRNA splice variants. that encode prematurely truncated, nonfunctional Na+ channels. Since circulating WBCs demonstrate similar SCN5A splicing patterns, we hypothesized that these WBC-derived splice variants might further stratify HF patients at risk for arrhythmias. Methods Simultaneously obtained myocardial core samples and WBCs were compared for SCN5A variants C (VC) and D (VD). Circulating variant levels were compared between HF patients divided into three groups: HF without an implantable cardioverter-defibrillator (ICD), HF with an ICD without appropriate intervention, and HF with an ICD with appropriate intervention. Results Myocardial tissue-derived SCN5A variant expression levels strongly correlated with circulating WBC samples for both VC and VD variants (r = 0.78 and 0.75, respectively). After controlling for covariates, HF patients who had received an appropriate ICD intervention had higher expression levels of both WBC-derived SCN5A variants compared to HF patients with ICDs who had not (OR= 3.25 (95% CI 1.64–6.45; p=0.001)). Receiver operating characteristics analysis revealed that circulating SCN5A variants levels were highly associated with the risk for appropriate ICD intervention (area under the curve ≥ 0.97). Conclusions Circulating expression levels of SCN5A variants were strongly associated with myocardial tissue levels. Furthermore, circulating variant levels were correlative with arrhythmic risk as measured by ICD events in a HF population within one year. PMID:24703920

Interactions between pacing and arrhythmia detection algorithms in the dual chamber implantable cardioverter defibrillator.

PubMed

Dijkman, B; Wellens, H J

2001-09-01

Dual chamber implantable cardioverter defibrillator (ICD) combines the possibility to detect and treat ventricular and atrial arrhythmias with the possibility of modern heart stimulation techniques. Advanced pacing algorithms together with extended arrhythmia detection capabilities can give rise to new types of device-device interactions. Some of the possible interactions are illustrated by four cases documented in four models of dual chamber ICDs. Functioning of new features in dual chamber devices is influenced by the fact that the pacemaker is not a separate device but a part of the ICD system and that both are being used in a patient with arrhythmia. Programming measures are suggested to optimize use of new pacing algorithms while maintaining correct arrhythmia detection.

Comparison of the Effects of High-Energy Photon Beam Irradiation (10 and 18 MV) on 2 Types of Implantable Cardioverter-Defibrillators

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

Hashii, Haruko, E-mail: haruko@pmrc.tsukuba.ac.jp; Hashimoto, Takayuki; Okawa, Ayako

2013-03-01

Purpose: Radiation therapy for cancer may be required for patients with implantable cardiac devices. However, the influence of secondary neutrons or scattered irradiation from high-energy photons (≥10 MV) on implantable cardioverter-defibrillators (ICDs) is unclear. This study was performed to examine this issue in 2 ICD models. Methods and Materials: ICDs were positioned around a water phantom under conditions simulating clinical radiation therapy. The ICDs were not irradiated directly. A control ICD was positioned 140 cm from the irradiation isocenter. Fractional irradiation was performed with 18-MV and 10-MV photon beams to give cumulative in-field doses of 600 Gy and 1600 Gy,more » respectively. Errors were checked after each fraction. Soft errors were defined as severe (change to safety back-up mode), moderate (memory interference, no changes in device parameters), and minor (slight memory change, undetectable by computer). Results: Hard errors were not observed. For the older ICD model, the incidences of severe, moderate, and minor soft errors at 18 MV were 0.75, 0.5, and 0.83/50 Gy at the isocenter. The corresponding data for 10 MV were 0.094, 0.063, and 0 /50 Gy. For the newer ICD model at 18 MV, these data were 0.083, 2.3, and 5.8 /50 Gy. Moderate and minor errors occurred at 18 MV in control ICDs placed 140 cm from the isocenter. The error incidences were 0, 1, and 0 /600 Gy at the isocenter for the newer model, and 0, 1, and 6 /600Gy for the older model. At 10 MV, no errors occurred in control ICDs. Conclusions: ICD errors occurred more frequently at 18 MV irradiation, which suggests that the errors were mainly caused by secondary neutrons. Soft errors of ICDs were observed with high energy photon beams, but most were not critical in the newer model. These errors may occur even when the device is far from the irradiation field.« less

An evaluation of ICD-11 posttraumatic stress disorder criteria in two samples of adolescents and young adults exposed to mass shootings: factor analysis and comparisons to ICD-10 and DSM-IV.

PubMed

Haravuori, Henna; Kiviruusu, Olli; Suomalainen, Laura; Marttunen, Mauri

2016-05-12

The proposed posttraumatic stress disorder (PTSD) criteria for the International Classification of Diseases (ICD) 11th revision are simpler than the criteria in ICD-10, DSM-IV or DSM-5. The aim of this study was to evaluate the ICD-11 PTSD factor structure in samples of young people, and to compare PTSD prevalence rates and diagnostic agreement between the different diagnostic systems. Possible differences in clinical characteristics of the PTSD cases identified by ICD-11, ICD-10 and DSM-IV are explored. Two samples of adolescents and young adults were followed after exposure to similar mass shooting incidents in their schools. Semi-structured diagnostic interviews were performed to assess psychiatric diagnoses and PTSD symptom scores (N = 228, mean age 17.6 years). PTSD symptom item scores were used to compose diagnoses according to the different classification systems. Confirmatory factor analyses indicated that the proposed ICD-11 PTSD symptoms represented two rather than three factors; re-experiencing and avoidance symptoms comprised one factor and hyperarousal symptoms the other factor. In the studied samples, the three-factor ICD-11 criteria identified 51 (22.4%) PTSD cases, the two-factor ICD-11 identified 56 (24.6%) cases and the DSM-IV identified 43 (18.9%) cases, while the number of cases identified by ICD-10 was larger, being 85 (37.3%) cases. Diagnostic agreement of the ICD-11 PTSD criteria with ICD-10 and DSM-IV was moderate, yet the diagnostic agreement turned to be good when an impairment criterion was imposed on ICD-10. Compared to ICD-11, ICD-10 identified cases with less severe trauma exposure and posttraumatic symptoms and DSM-IV identified cases with less severe trauma exposure. The findings suggest that the two-factor model of ICD-11 PTSD is preferable to the three-factor model. The proposed ICD-11 criteria are more restrictive compared to the ICD-10 criteria. There were some differences in the clinical characteristics of the PTSD cases

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

PubMed

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

2014-01-21

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

Expenditure and value for money: the challenge of implantable cardioverter defibrillators.

PubMed

Boriani, G; Biffi, M; Martignani, C; Diemberger, I; Valzania, C; Bertini, M; Branzi, A

2009-05-01

Many technology-driven interventions entail considerable financial cost, raising affordability issues. The implantable cardioverter defibrillator (ICD) is a case of an effective primary prevention intervention with high initial costs that is capable of delivering long-term population benefits. At first glance, such interventions may provoke diffidence, if not active resistance, due to the financial burdens which inevitably accompany their widespread adoption. In this article, we review the available economic tools that can help address the ICD cost issue. We think awareness of such knowledge may facilitate dialogues between physicians, administrators and policymakers, and help foster rational decision-making.

Impact of remote monitoring on the management of arrhythmias in patients with implantable cardioverter-defibrillator.

PubMed

Marcantoni, Lina; Toselli, Tiziano; Urso, Giulia; Pratola, Claudio; Ceconi, Claudio; Bertini, Matteo

2015-11-01

In the last decade, there has been an exponential increase in cardioverter-defibrillator (ICD) implants. Remote monitoring systems, allow daily follow-ups of patients with ICD. To evaluate the impact of remote monitoring on the management of cardiovascular events associated with supraventricular and ventricular arrhythmias during long-term follow-up. A total of 207 patients undergoing ICD implantation/replacement were enrolled: 79 patients received remote monitoring systems and were followed up every 12 months, and 128 patients were followed up conventionally every 6 months. All patients were followed up and monitored for the occurrence of supraventricular and ventricular arrhythmia-related cardiovascular events (ICD shocks and/or hospitalizations). During a median follow-up of 842 days (interquartile range 476-1288 days), 32 (15.5%) patients experienced supraventricular arrhythmia-related events and 51 (24.6%) patients experienced ventricular arrhythmia-related events. Remote monitoring had a significant role in the reduction of supraventricular arrhythmia-related events, but it had no effect on ventricular arrhythmia-related events. In multivariable analysis, remote monitoring remained as an independent protective factor, reducing the risk of supraventricular arrhythmia-related events of 67% [hazard ratio, 0.33; 95% confidence interval (CI), 0.13-0.82; P = 0.017]. Remote monitoring systems improved outcomes in patients with supraventricular arrhythmias by reducing the risk of cardiovascular events, but no benefits were observed in patients with ventricular arrhythmias.

Changes in Implantation Patterns and Therapy Rates of Implantable Cardioverter Defibrillators over Time in Ischemic and Dilated Cardiomyopathy Patients.

PubMed

Vandenberk, Bert; Garweg, Christophe; Voros, Gabor; Floré, Vincent; Marynissen, Thomas; Sticherling, Christian; Zabel, Markus; Ector, Joris; Willems, Rik

2016-08-01

Clinical guidelines on implantable cardioverter defibrillator (ICD) therapy changed significantly in the last decades with potential inherent effects on therapy efficacy. We aimed to study therapy rates in time and the association between therapies and mortality. All patients receiving an ICD, primary and secondary prevention, were included in a single-center retrospective registry. Information on first appropriate and inappropriate therapies was documented. Dates of implant were divided in P1: 1996-2001, P2: 2002-2008, and P3: 2009-2014. A total of 727 patients, 84.9% male-66.4% ischemic cardiomyopathy (ICM)-56% primary prevention-mean follow-up 5.2 ± 4.1 years, were included. There was a shift from secondary to primary prevention indications, from ischemic to non-ICM, and from single chamber to cardiac resynchronization therapy defibrillator devices. The annual 1- and 3-year appropriate shock (AS) rate declined from 29.4% and 15.1% in P1, over 13.3% and 9.2% in P2 to 7.8% and 5.7% in P3 (log-rank P < 0.001), while inappropriate shock (IAS) rates remained unchanged (log-rank P = 0.635). After multivariate regression analysis a higher age at implant, lower left ventricular ejection fraction, history of stroke, diabetes mellitus, intake of loop diuretics or digitalis, higher creatinine, and longer QTc were independent predictors of mortality. These changes in clinical practice with a shift to primary prevention and rise in non-ICM implants caused a significant decrease in AS incidence, while IAS remained stable. Receiving AS or IAS was not an independent predictor of mortality in our real-life cohort. © 2016 Wiley Periodicals, Inc.

Evolution of power sources for implantable cardioverter defibrillators

NASA Astrophysics Data System (ADS)

Crespi, Ann M.; Somdahl, Sonja K.; Schmidt, Craig L.; Skarstad, Paul M.

The evolution of seven generations of power sources for implantable cardioverter defibrillators (ICD) is presented. The packaging efficiency of the power sources has steadily increased, resulting in smaller, lighter batteries while maintaining the required electrical characteristics. The main areas for improvement were reduction of headspace volume, reduction of separator volume, and a change from a two-cell battery to a single cell.

Inappropriate ICD discharges due to "triple counting" during normal sinus rhythm.

PubMed

Khan, Ejaz; Voudouris, Apostolos; Shorofsky, Stephen R; Peters, Robert W

2006-11-01

To describe the clinical course of a patient with multiple ICD shocks in the setting of advanced renal failure and hyperkalemia. The patient was brought to the Electrophysiology Laboratory where the ICD was interrogated. The patient was found to be hyperkalemic (serum potassium 7.6 mg/dl). Analysis of stored intracardiac electrograms from the ICD revealed "triple counting" (twice during his QRS complex and once during the T wave) and multiple inappropriate shocks. Correction of his electrolyte abnormality normalized his electrogram and no further ICD activations were observed. Electrolyte abnormalities can distort the intracardiac electrogram in patients with ICD's and these changes can lead to multiple inappropriate shocks.

Position paper for management of elderly patients with pacemakers and implantable cardiac defibrillators: Groupe de Rythmologie et Stimulation Cardiaque de la Société Française de Cardiologie and Société Française de Gériatrie et Gérontologie.

PubMed

Fauchier, Laurent; Alonso, Christine; Anselme, Frederic; Blangy, Hugues; Bordachar, Pierre; Boveda, Serge; Clementy, Nicolas; Defaye, Pascal; Deharo, Jean-Claude; Friocourt, Patrick; Gras, Daniel; Halimi, Franck; Klug, Didier; Mansourati, Jacques; Obadia, Benjamin; Pasquié, Jean-Luc; Pavin, Dominique; Sadoul, Nicolas; Taieb, Jerome; Piot, Olivier; Hanon, Olivier

2016-10-01

Despite the increasingly high rate of implantation of pacemakers (PMs) and implantable cardioverter defibrillators (ICDs) in elderly patients, data supporting their clinical and cost-effectiveness in this age stratum are ambiguous and contradictory. We reviewed the data regarding the applicability, safety and effectiveness of conventional pacing, ICDs and cardiac resynchronization therapy (CRT) in elderly patients. Although periprocedural risk may be slightly higher in the elderly, the implantation procedure for PMs and ICDs is still relatively safe in this age group. In older patients with sinus node disease, the general consensus is that DDD pacing with the programming of an algorithm to minimize ventricular pacing is preferred. In very old patients presenting with intermittent or suspected atrioventricular block, VVI pacing may be appropriate. In terms of correcting potentially life-threatening arrhythmias, the effectiveness of ICD therapy is similar in older and younger individuals. However, the assumption of persistent ICD benefit in the elderly population is questionable, as any advantageous effect of the device on arrhythmic death may be attenuated by higher total non-arrhythmic mortality. While septuagenarians and octogenarians have higher annual all-cause mortality rates, ICD therapy may remain effective in selected patients at high risk of arrhythmic death and with minimum comorbidities despite advanced age. ICD implantation among the elderly, as a group, may not be cost-effective, but the procedure may reach cost-effectiveness in those expected to live more than 5-7years after implantation. Elderly patients usually experience significant functional improvement after CRT, similar to that observed in middle-aged patients. Management of CRT non-responders remains globally the same, while considering a less aggressive approach in terms of reinterventions (revision of left ventricular [LV] lead placement, addition of a right ventricular or LV lead, LV

Temporal trend analysis of nurses' knowledge about implantable cardioverter defibrillators.

PubMed

Norekvål, Tone M; Peersen, Lene R L; Seivaag, Kirsten; Fridlund, Bengt; Wentzel-Larsen, Tore

2015-05-01

Although crucial, research on nurses' knowledge on the use of implantable cardioverter defibrillators (ICDs) is scant. The aims of the study were to investigate (i) the level of nurses' knowledge on care of patients with ICDs, (ii) whether knowledge level is related to education and type of hospital where nurses practice and (iii) whether knowledge level changes among nurses over time. We developed a questionnaire comprising 27 items in four parts: (1) Sociodemographics, (2) Technical facts about ICDs, (3) Daily life challenges and (4) Self-evaluation of knowledge. After validation, surveys were conducted during 1-week cardiac educational courses in 2003-2010. In total, 463 nurses working in cardiology-related areas participated, yielding a response rate of 91%. Practical and technical knowledge about ICDs was lacking. Nurses were unaware or did not know that mobile phones can affect the device (80%), that patients are restricted from driving heavy vehicles (69%), and that ICDs can deliver unintended shock therapy (73%). However, they were aware that ICD patients can resume sexual (87%) and physical activity (85%). There were few significant differences with regard to education and type of hospital where nurses practiced, but significant time trends in correct answers regarding kitchen appliances, resumption of physical activity and shock delivery. Over an 8-year period, despite the increased usage of ICDs, overall nurses had a lack of knowledge in relation to specific key clinical issues on the care of ICD patients. As a consequence, these patients may fail to receive qualified care. Future research should assess knowledge of other health care professionals and focus on interventions that increase and maintain an appropriate knowledge level in care of ICD patients. Relevance to clinical practice The level of nurses' knowledge on care of patients with ICDs needs to be systematically raised in order to ensure appropriate counselling and nursing care. © 2014 British

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.

Electromagnetic interference with cardiac pacemakers and implantable cardioverter-defibrillators from low-frequency electromagnetic fields in vivo.

PubMed

Tiikkaja, Maria; Aro, Aapo L; Alanko, Tommi; Lindholm, Harri; Sistonen, Heli; Hartikainen, Juha E K; Toivonen, Lauri; Juutilainen, Jukka; Hietanen, Maila

2013-03-01

Electromagnetic interference (EMI) can pose a danger to workers with pacemakers and implantable cardioverter-defibrillators (ICDs). At some workplaces electromagnetic fields are high enough to potentially inflict EMI. The purpose of this in vivo study was to evaluate the susceptibility of pacemakers and ICDs to external electromagnetic fields. Eleven volunteers with a pacemaker and 13 with an ICD were exposed to sine, pulse, ramp, and square waveform magnetic fields with frequencies of 2-200 Hz using Helmholtz coil. The magnetic field flux densities varied to 300 µT. We also tested the occurrence of EMI from an electronic article surveillance (EAS) gate, an induction cooktop, and a metal inert gas (MIG) welding machine. All pacemakers were tested with bipolar settings and three of them also with unipolar sensing configurations. None of the bipolar pacemakers or ICDs tested experienced interference in any of the exposure situations. The three pacemakers with unipolar settings were affected by the highest fields of the Helmholtz coil, and one of them also by the EAS gate and the welding cable. The induction cooktop did not interfere with any of the unipolarly programmed pacemakers. Magnetic fields with intensities as high as those used in this study are rare even in industrial working environments. In most cases, employees can return to work after implantation of a bipolar pacemaker or an ICD, after an appropriate risk assessment. Pacemakers programmed to unipolar configurations can cause danger to their users in environments with high electromagnetic fields, and should be avoided, if possible.

Could implantable cardioverter defibrillators provide a human model supporting the learned helplessness theory of depression?

PubMed

Goodman, M; Hess, B

1999-01-01

Affective symptoms were examined retrospectively in 25 patients following placement of implantable cardioverter defibrillators (ICD) which can produce intermittent shocks without warning in response to cardiac ventricular arrhythmias. The number of ICD random, uncontrollable discharge shocks and pre-ICD history of psychological distress (i.e., depression and/or anxiety) were documented in all patients using a demographics questionnaire and a standardized behavioral/psychological symptoms questionnaire (i.e., Symptom Checklist-90 Revised). ICD patients were dichotomized into two groups: those without a history of psychological distress prior to ICD (n = 18) and those with a history of psychological distress prior to ICD (n = 7). In ICD patients without a prior history, results indicated that quantity of ICD discharge shocks was significantly predictive of current reported depression (r = 0.45, p = 0.03) and current reported anxiety (r = 0.51, p = 0.02). Conversely, in patients with a reported history of psychological distress, there was no significant relationship found between quantity of discharge shocks and current reported depression or anxiety. This study may provide evidence in support of a human model of learned helplessness in that it supports the notion that exposure to an unavoidable and inescapable aversive stimulus was found to be related to patients' reported depression. Further studies may wish to prospectively consider a larger sample as well as a more comprehensive assessment of premorbid psychological symptoms.

Help seeking in a support group for recipients of implantable cardioverter defibrillators and their support persons.

PubMed

Dickerson, S S; Posluszny, M; Kennedy, M C

2000-01-01

To understand shared meanings of help-seeking experiences in support groups of people with implantable cardioverter defibrillator (ICD) and their support persons. ICD support group at an urban medical center. Fifteen individuals with ICD and 9 support persons. Six related themes and 1 constitutive pattern emerged. Themes included hearing and telling stories, help seeking encouraged by triggers, seeking meaningful information, forming a therapeutic friendship through group camaraderie, gaining assistance from the facilitator, and the sharing of a similar view by support persons. The constitutive pattern is coping with the possibility of death. Health care providers may recommend storytelling as the central mechanism of interactions in support groups that assist in coping with daily anxieties of living with an ICD. Nurses would be appropriate facilitators to guide discussion, to provide technical information, and to promote anticipatory guidance in coping with potential firing events.

Right ventricular apical versus non-apical implantable cardioverter defibrillator lead: A systematic review and meta-analysis.

PubMed

Garg, Jalaj; Chaudhary, Rahul; Shah, Neeraj; Palaniswamy, Chandrasekar; Bozorgnia, Babak; Nazir, Talha; Natale, Andrea; Kutyifa, Valentina

We aimed to study the effect of right ventricular implantable cardioverter defibrillator (ICD) lead positioning on clinical outcomes in patients undergoing ICD placement. A systematic literature search was performed using PubMed, EMBASE, Web of Science, and Cochrane Central Register of Controlled Trials to identify clinical trials comparing outcomes in patients with ICD leads in apical and non-apical positions. The primary outcome of our study was death at 1-year follow-up. Secondary outcomes studied were "death at 3years", "total number of shocks", "appropriate shocks", "inappropriate shocks" and "cut-to-suture time". We analyzed a total of 3731 patients (2852 in apical and 879 in non-apical ICD groups) enrolled in 4 clinical trials. No significant difference was observed between the apical and non-apical ICD groups in all-cause mortality at 1year (OR 0.88; 95% CI 0.51-1.49, p=0.63; I 2 =5.32%). Similarly, no differences were seen between the two groups in death at 3years (OR=0.76; 95% CI 0.56-1.04, p=0.08; I 2 =0%), total number of shocks (OR 0.99; 95% CI 0.81-1.22, p=0.95; I 2 =0%), appropriate shocks (OR 1.00; 95% CI 0.79-1.27, p=0.99; I 2 =0%), inappropriate shocks (OR 0.98; 95% CI 0.70-1.37, p=0.91; I 2 =0%) and cut-to-suture time (Standard mean difference=-0.03; 95% CI -0.20 to 0.14, p=0.73; I 2 =0%). No publication bias was seen. Non-apical RV ICD lead implantation is non-inferior to traditional RV apical position with no significant differences in mortality, total number of shocks, appropriate shocks, inappropriate shocks and procedural time. Copyright © 2017 Elsevier Inc. All rights reserved.

The effect of implant macro-thread design on implant stability in the early post-operative period: a randomized, controlled pilot study.

PubMed

McCullough, Jeffrey J; Klokkevold, Perry R

2017-10-01

Available literature suggests there is a transient drop in implant stability from approximately week 0 to week 3-4 as a result of peri-implant bone remodeling as it transitions from a primary, mechanical stability to a secondary, biological stability. Research investigating the influence of macro-thread design on this process is scant. The specific aim of this study was to evaluate the role of macro-thread design on implant stability in the early post-operative healing period using resonance frequency analysis (RFA). Seven patients, each missing at least two posterior teeth in the same arch, were included in the study. Three patients qualified for four implants resulting in a total of 10 matched pairs. All sites were healed (>6 months), non-grafted sites with sufficient bone to place implants. Each site in a matched pair was randomly assigned to receive either a control (Megagen EZ Plus Internal; EZ) or test (Megagen AnyRidge; AR) implant. The test implant incorporates a novel thread design with a wide thread depth and increased thread pitch. RFA was used to determine implant stability quotient (ISQ) values for each implant at the time of placement and weekly for the first 8 weeks. Implants consistently achieved a relatively high insertion torque (30-45 N/cm) and high initial ISQ value (79.8 ± 1.49). Baseline ISQ values for test (AR; 79.55 ± 1.61) and control (EZ; 80.05 ± 1.37) implants were similar. A general pattern of stability from baseline through all eight follow-up evaluations was observed for the test implants. A pattern of decreasing ISQ values was observed for the control implants across the early follow-up evaluations up to week four, where the value plateaued. There was a statistically significant main effect due to implant type (P < 0.01) and a statistically significant interaction between implant type and time (P < 0.01), indicating that the test and control implants performed differently at certain time points. Within the limitations

Piloting a Collaborative Web-Based System for Testing ICD-11.

PubMed

Donada, Marc; Kostanjsek, Nenad; Della Mea, Vincenzo; Celik, Can; Jakob, Robert

2017-01-01

The 11^th revision of the International Classification of Diseases (ICD-11), for the first time in ICD history, deployed web-based collaboration of experts and ICT tools. To ensure that ICD-11 is working well, it needs to be systematically field tested in different settings, across the world. This will be done by means of a number of experiments. In order to support its implementation, a web-based system (ICDfit) has been designed and developed. The present paper illustrates the current prototype of the system and its technical testing. the system has been designed according to WHO requirements, and implemented using PHP and MySQL. Then, a preliminary technical test has been designed and run in January 2016, involving 8 users. They had to carry out double coding, that is, coding case summaries with both ICD-10 and ICD-11, and answering quick questions on the coding difficulty. the 8 users coded 632 cases each, spending an average of 163 seconds per case. While we found an issue in the mechanism used to record coding times, no further issues were found. the proposed system seems to be technically adequate for supporting future ICD-11 testing.

Decision-Making of Patients With Implantable Cardioverter-Defibrillators at End of Life: Family Members' Experiences.

PubMed

Lee, Mei Ching; Sulmasy, Daniel P; Gallo, Joseph; Kub, Joan; Hughes, Mark T; Russell, Stuart; Kellogg, Anela; Owens, Sharon G; Terry, Peter; Nolan, Marie T

2017-07-01

Many patients with advanced heart failure (HF) experience the life-extending benefits of implantable cardioverter-defibrillators (ICD), but at the end stage of HF, patients may experience shocks with increasing frequency and change the plan for end-of-life (EOL) care including the deactivation of the ICD. This report describes family members' experiences of patients with ICD making decisions at EOL. Understanding the decision-making of patients with ICD at EOL can promote informed decision-making and improve the quality of EOL care. This pilot study used a mixed methods approach to test the effects of a nurse-guided discussion in decision-making about ICD deactivation (turning off the defibrillation function) at the EOL. Interviews were conducted, audiotaped, and transcribed in 2012 to 2013 with 6 family members of patients with advanced HF and ICDs. Three researchers coded the data and identified themes in 2014. Three main themes described family members' experiences related to patients having HF with ICDs making health-care decision at EOL: decision-making preferences, patients' perception on ICD deactivation, and communication methods. Health-care providers need to have knowledge of patients' decision-making preferences. Preferences for decision-making include the allowing of appropriate people to involve and encourages direct conversation with family members even when advance directives is completed. Information of ICD function and the option of deactivation need to be clearly delivered to patients and family members. Education and guidelines will facilitate the communication of the preferences of EOL care.

Magnetic resonance imaging in patients with cardiac implanted electronic devices: focus on contraindications to magnetic resonance imaging protocols.

PubMed

Horwood, Laura; Attili, Anil; Luba, Frank; Ibrahim, El-Sayed H; Parmar, Hemant; Stojanovska, Jadranka; Gadoth-Goodman, Sharon; Fette, Carey; Oral, Hakan; Bogun, Frank

2017-05-01

Magnetic resonance imaging (MRI) has been reported to be safe in patients with cardiac implantable electronic devices (CIED) provided a specific protocol is followed. The objective of this study was to assess whether this is also true for patients excluded from published protocols. A total of 160 MRIs were obtained in 142 consecutive patients with CIEDs [106 patients had an implantable cardioverter defibrillator (ICD) and 36 had a pacemaker implanted] using an adapted, pre-specified protocol. A cardiac MRI was performed in 95 patients, and a spinal/brain MRI was performed in 47 patients. Forty-six patients (32%) had either abandoned leads (n = 10), and/or were pacemaker dependent with an implanted ICD (n = 19), had recently implanted CIEDs (n = 1), and/or had a CIED device with battery depletion (n = 2), and/or a component of the CIED was recalled or on advisory (n = 32). No major complications occurred. Some device parameters changed slightly, but significantly, right after or at 1-week post-MRI without requiring any reprogramming. In one patient with an ICD on advisory, the pacing rate changed inexplicably during one of his two MRIs from 90 to 50 b.p.m. Using a pre-specified protocol, cardiac and non-cardiac MRIs were performed in CIED patients with pacemaker dependency, abandoned leads, or depleted batteries without occurrence of major adverse events. Patients with devices on advisory need to be monitored carefully during MRI, especially if they are pacemaker dependent. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

The Tragedy of the Implementation of ICD-10-CM as ICD-10: Is the Cart Before the Horse or Is There a Tragic Paradox of Misinformation and Ignorance?

PubMed

Manchikanti, Laxmaiah; Kaye, Alan D; Singh, Vijay; Boswell, Mark V

2015-01-01

The forced implementation of ICD-10-CM (International Classification of Diseases, Tenth Revision, Clinical Modification) codes that are specific to the United States, scheduled for implementation October 1, 2015, which is vastly different from ICD-10 (International Classification of Diseases, Tenth Revision), implemented worldwide, which has 14,400 codes, compared to ICD-10-CM with 144,000 codes to be implemented in the United States is a major concern to practicing U.S. physicians and a bonanza for health IT and hospital industry. This implementation is based on a liberal interpretation of the Health Insurance Portability and Accountability Act (HIPAA), which requires an update to ICD-9-CM (International Classification of Diseases, Ninth Revision, Clinical Modification) and says nothing about ICD-10 or beyond. On June 29, 2015, the Supreme Court ruled that the Environmental Protection Agency unreasonably interpreted the Clean Air Act when it decided to set limits on the emissions of toxic pollutants from power plants, without first considering the costs on the industry. Thus, to do so is applicable to the medical industry with the Centers for Medicare and Medicaid Services (CMS) unreasonably interpreting HIPAA and imposing existent extensive regulations without considering the cost. In the United States, ICD-10-CM with a 10-fold increase in the number of codes has resulted in a system which has become so complicated that it no longer compares with any other country. Moreover, most WHO members use the ICD-10 system (not ICD-10-CM) only to record mortality in 138 countries or morbidity in 99 countries. Currently, only 10 countries employ ICD-10 (not ICD-10-CM) in the reimbursement process, 6 of which have a single payer health care system. Development of ICD-10-CM is managed by 4 non-physician groups, known as cooperating parties. They include the Centers for Disease Control and Prevention (CDC), CMS, the American Hospital Association (AHA), and the American Health

A review of the evidence on the effects and costs of implantable cardioverter defibrillator therapy in different patient groups, and modelling of cost-effectiveness and cost-utility for these groups in a UK context.

PubMed

Buxton, M; Caine, N; Chase, D; Connelly, D; Grace, A; Jackson, C; Parkes, J; Sharples, L

2006-08-01

To update the systematic review evidence on the effectiveness, health-related quality of life (HRQoL) and cost-effectiveness of implantable cardioverter defibrillators (ICDs); compilation of new data on the service provision in the UK; and on the clinical characteristics, survival, quality of life and costs of ICD patients in the UK, and a new cost-effectiveness model using both international RCT and UK-specific data. Electronic databases searched from November 1999 to March 2003, this was supplemented by a systematic review of research published during 2003-5. Survey data. Studies were selected and assessed. A survey of ICD centres was carried out. Basic data were obtained from two major implanting centres including 535 patients (approximately 10% of overall UK activity) implanted between 1991 and 2002, and retrieval of fuller data, on patient characteristics, management and resource use, from patient notes for a sample of 426 patients was attempted. A cross-sectional survey collected HRQoL data (using the Nottingham Health Profile, Short Form 36, Hospital Anxiety and Depression questionnaire, EuroQoL 5 Dimensions and disease-specific questions) on a sample of 229 patients. A Markov model combined UK patient data with data from published randomised controlled trials (RCTs) to estimate incremental costs per life-year or quality-adjusted life-year (QALY) gained. None of the economic analyses in the studies found could be directly applied to the UK. The multiple sources of routine data available (including the national ICD database) provide an imperfect picture of the need for and use of ICDs. Implantation rates have been rising to a rate of around 20 per million population. Mean age is increasing and most ICDs are implanted into men aged 45-74 years. There is significant geographical variation. A survey of 41 UK centres provided additional evidence, particularly of variation in level of activity and resourcing. Most detailed data were obtained for 380 patients (89

Do physicians' attitudes toward implantable cardioverter defibrillator therapy vary by patient age, gender, or race?

PubMed

Al-Khatib, Sana M; Sanders, Gillian D; O'Brien, Sean M; Matlock, Daniel; Zimmer, Louise O; Masoudi, Frederick A; Peterson, Eric

2011-01-01

Implantable cardioverter defibrillator (ICD) therapy improves survival of patients with systolic heart failure. We assessed whether physicians' recommendation for ICD therapy varies as a function of patient age, gender, race, and physician's specialty. We surveyed a random sample (n = 9969) of U.S. physicians who are active members of the American College of Cardiology (ACC). We asked participants about their likelihood to recommend ICD therapy in 4 clinical scenarios that randomly varied patient age, gender, race, and ICD indication (guideline Class I, Class IIa, Class III, and Class I in a noncompliant patient). Responses were received from 1210 physicians (response rate 12%), of whom 1127 met the study inclusion criteria. Responders and nonresponders had similar demographics. In responding to hypothetical clinical scenarios, physicians were less likely to recommend an ICD to older patients (≥80 vs 50 years) (P < 0.01) but were unaffected by gender or race for all class indications. Compared with non-electrophysiologists (EPs), EPs were significantly more likely to recommend an ICD for a Class I indication (92.4% vs 81.4%; P < 0.01), but they were not more likely to offer an ICD for a Class III indication (0.4% vs 0.6%; P = 0.95). Based on survey responses, physicians were equally willing to offer an ICD to men and women and to whites and blacks, but were less likely to offer an ICD to an older patient even when indicated by practice guidelines. Electrophysiologists (EPs) more often adhered to practice guideline recommendations on ICD therapy compared with non-EPs. ©2011, Wiley Periodicals, Inc.

Identification of ICD Codes Suggestive of Child Maltreatment

ERIC Educational Resources Information Center

Schnitzer, Patricia G.; Slusher, Paula L.; Kruse, Robin L.; Tarleton, Molly M.

2011-01-01

Objective: In order to be reimbursed for the care they provide, hospitals in the United States are required to use a standard system to code all discharge diagnoses: the International Classification of Disease, 9th Revision, Clinical Modification (ICD-9). Although ICD-9 codes specific for child maltreatment exist, they do not identify all…

Diagnostic Concordance between DSM-5 and ICD-10 Cannabis Use Disorders.

PubMed

Proctor, Steven L; Williams, Daniel C; Kopak, Albert M; Voluse, Andrew C; Connolly, Kevin M; Hoffmann, Norman G

2016-07-01

With the recent federal mandate that all U.S. health care settings transition to ICD-10 billing codes, empirical evidence is necessary to determine if the DSM-5 designations map to their respective ICD-10 diagnostic categories/billing codes. The present study examined the concordance between DSM-5 and ICD-10 cannabis use disorder diagnoses. Data were derived from routine clinical assessments of 6871 male and 801 female inmates recently admitted to a state prison system from 2000 to 2003. DSM-5 and ICD-10 diagnostic determinations were made from algorithms corresponding to the respective diagnostic formulations. Past 12-month prevalence rates of cannabis use disorders were comparable across classification systems. The vast majority of inmates with no DSM-5 diagnosis continued to have no diagnosis per the ICD-10, and a similar proportion with a DSM-5 severe diagnosis received an ICD-10 dependence diagnosis. Most of the variation in diagnostic classifications was accounted for by those with a DSM-5 moderate diagnosis in that approximately half of these cases received an ICD-10 dependence diagnosis while the remaining cases received a harmful use diagnosis. Although there appears to be a generally high level of agreement between diagnostic classification systems for those with no diagnosis or those evincing symptoms of a more severe condition, concordance between DSM-5 moderate and ICD-10 dependence diagnoses was poor. Additional research is warranted to determine the appropriateness and implications of the current DSM-5 coding guidelines regarding the assignment of an ICD-10 dependence code for those with a DSM-5 moderate diagnosis. Copyright © 2016 Elsevier Ltd. All rights reserved.

The subcutaneous implantable cardioverter-defibrillator.

PubMed

Grace, Andrew

2014-01-01

To consider the case of need that underpinned the development of the subcutaneous implantable cardioverter-defibrillator (SICD), the preclinical and clinical data obtained so far, its current role and likely future. The data from prospective clinical evaluation of the device demonstrated safety and efficacy leading to Food and Drug Administration approval. This superseded earlier reports from Europe that raised some clinical concerns, previously anticipated through the introduction of new technology. Recent estimates indicate maybe 55% of patients in routine clinical practice needing an ICD are potentially suitable for a subcutaneous device. The SICD provides a useful alternative for high-energy (ICD) therapy in those deemed at risk and who need defibrillation and in whom there are no indications for cardiac resynchronization, bradycardia support or antitachycardia pacing. There is the possibility of both higher specificity and the avoidance of myo-cellular damage with shock delivery, and if these two aspects play out subcutaneous defibrillation could become an option of choice in many settings.

Examination of the Effect of Implantable Cardioverter-Defibrillators on Health-Related Quality of Life

PubMed Central

Noyes, Katia; Corona, Ethan; Veazie, Peter; Dick, Andrew W.; Zhao, Hongwei; Moss, Arthur J.

2015-01-01

Background While implantable cardioverter-defibrillators (ICDs) improve survival, their benefit in terms of health-related quality of life (HRQOL) is negligible. Objective To examine how shocks and congestive heart failure (CHF) mediate the effect of ICDs on HRQOL. Methods The US patients from the MADIT-II (Multicenter Automatic Defibrillator Trial-II) trial (n = 983) were randomized to receive an ICD or medical treatment only. HRQOL was assessed using the Health Utility Index 3 at baseline and 3, 12, 24, and 36 months following randomization. Logistic regressions were used to test for the effect of ICDs on the CHF indicator, and linear regressions were used to examine the effect of ICD shocks and CHF on HRQOL in living patients. We used a Monte Carlo simulation and a parametric Weibull distribution survival model to test for the effect of selective attrition. Observations were clustered by patients and robust standard errors (RSEs) were used to control for the non-independence of multiple observations provided by the same patient. Results Patients in the ICD arm had 41% higher odds of experiencing CHF since their last assessment compared with those in the control arm (RSE = 0.19, p = 0.01). Developing CHF reduced HRQOL at the subsequent visit by 0.07 (p < 0.01). Having ICD shocks reduced overall HRQOL by 0.04 (p = 0.04) at the subsequent assessment. The negative effect of ICD firing on HRQOL was an order of magnitude greater than the effect of CHF. Conclusions A higher prevalence of CHF and shocks among patients with ICDs and their negative effect on HRQOL may partially explain the lack of HRQOL benefit of ICD therapy. PMID:19929037

A Strategic Plan for Integrating ICD-10 in Your Practice and Workflow.

PubMed

Bowman, Sue; Cleland, Risë Marie; Staggs, Stuart

2015-01-01

The adoption of the International Classification of Disease (ICD) 10th Revision (ICD-10) diagnosis code set in the United States has been legislatively delayed several times with the most recent date for implementation set for October 1, 2015. The transition from ICD-9 to ICD-10 will be a major undertaking that will require a substantial amount of planning. In the following article, we outline the steps to develop and implement a strategic plan for the transition to the new code set, identify training needs throughout the practice, and review the challenges and opportunities associated with the transition to ICD-10.

Effect of supplemented intake of omega-3 fatty acids on arrhythmias in patients with ICD: fish oil therapy may reduce ventricular arrhythmia.

PubMed

Weisman, Dalit; Beinart, Roy; Erez, Aharon; Koren-Morag, Nira; Goldenberg, Ilan; Eldar, Michael; Glikson, Michael; Luria, David

2017-09-01

The aim of this study was to evaluate the effects of fish oils, including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), on ventricular tachyarrhythmic episodes (VTEs) in implantable cardioverter defibrillator (ICD) recipients with ischemic cardiomyopathy. One hundred five ICD recipients with ischemic cardiomyopathy received 3.6 g of EPA and DHA and placebo for 6 months, each at a random order, with a 4-month washout period between treatments. Eighty-seven patients completed the 16-month study protocol. The primary end point was any VTE (including sustained and non-sustained ventricular tachycardias at a rate of >150 bpm) as recorded by the ICDs. Secondary end points included device therapy (anti-tachycardia pacing (ATP) or shocks). During treatment with fish oils, there was a significant increase in EPA and DHA concentrations in red blood cells (RBCs) and subcutaneous fat tissue. Among 87 patients who completed the study protocol, the mean number of VTEs was significantly lower during treatment with fish oil (1.7) vs. placebo (5.6; p = 0.035). Appropriate device therapy for VTE occurred in 18 (21%) patients. Fish oil therapy was associated with a trend toward fewer VTEs terminated with ATP (2.8 ± 13.7 vs. 0.5 ± 2.1, respectively; p = 0.077). VTE terminated by ICD shocks, however, was rare, and rates were similar between both groups (0.11 ± 0.6 vs. 0.10 ± 0.4, p = not significant, respectively). Our data suggest that fish oil therapy may be associated with a reduction in the frequency of VTE in ICD recipients with ischemic cardiomyopathy.

Decreased delivery of inappropriate shocks achieved by remote monitoring of ICD: a substudy of the ECOST trial.

PubMed

Guédon-Moreau, Laurence; Kouakam, Claude; Klug, Didier; Marquié, Christelle; Brigadeau, François; Boulé, Stéphane; Blangy, Hugues; Lacroix, Dominique; Clémenty, Jacques; Sadoul, Nicolas; Kacet, Salem

2014-07-01

Inappropriate shocks remain a highly challenging complication of implantable cardioverter defibrillators (ICD). We examined whether automatic wireless remote monitoring (RM) of ICD, by providing early notifications of triggering events, lowers the incidence of inappropriate shocks. We studied 433 patients randomly assigned to RM (n = 221; active group) versus ambulatory follow-up (n = 212; control group). Patients in the active group were seen in the ambulatory department once a year, unless RM reported an event requiring an earlier ambulatory visit. Patients in the control group were seen in the ambulatory department every 6 months. The occurrence of first and further inappropriate shocks, and their causes in each group were compared. The characteristics of the study groups, including pharmaceutical regimens, were similar. Over a follow-up of 27 months, 5.0% of patients in the active group received ≥1 inappropriate shocks versus 10.4% in the control group (P = 0.03). A total of 28 inappropriate shocks were delivered in the active versus 283 in the control group. Shocks were triggered by supraventricular tachyarrhythmias (SVTA) in 48.5%, noise oversensing in 21.2%, T wave oversensing in 15.2%, and lead dysfunction in 15.2% of patients. The numbers of inappropriate shocks delivered per patient, triggered by SVTA and by lead dysfunction, were 74% and 98% lower, respectively, in the active than in the control group. RM was highly effective in the long-term prevention of inappropriate ICD shocks. © 2014 Wiley Periodicals, Inc.

Potential for Personal Digital Assistant interference with implantable cardiac devices.

PubMed

Tri, Jeffrey L; Trusty, Jane M; Hayes, David L

2004-12-01

To determine whether the wireless local area network (WLAN) technology, specifically the Personal Digital Assistant (PDA), interferes with implantable cardiac pacemakers and defibrillators. Various pacemakers and defibrillators were tested in vitro at the Mayo Clinic in Rochester, Minn, between March 6 and July 30, 2003. These cardiac devices were exposed to an HP Compaq IPAQ PDA fitted with a Cisco Aironet WLAN card. Initial testing was designed to show whether the Aironet card radiated energy in a consistent pattern from the antenna of the PDA to ensure that subsequent cardiac device testing would not be affected by the orientation of the PDA to the cardiac device. Testing involved placing individual cardiac devices in a simulator and uniformly exposing each device at its most sensitive programmable value to the WLAN card set to maximum power. During testing with the Cisco WLAN Aironet card, all devices programmed to the unipolar or bipolar configuration single- or dual-chamber mode had normal pacing and sensing functions and exhibited no effects of electromagnetic interference except for 1 implantable cardioverter-defibrillator (ICD). This aberration was determined to relate to the design of the investigators' testing apparatus and not to the output of the PDA. The ICD device appropriately identified and labeled the electromagnetic aberration as "noise." We documented no electromagnetic interference caused by the WLAN technology by using in vitro testing of pacemakers and ICDs; however, testing ideally should be completed in vivo to confirm the lack of any clinically important interactions.

Sex difference in appropriate shocks but not mortality during long-term follow-up in patients with implantable cardioverter-defibrillators

PubMed Central

Seegers, Joachim; Conen, David; Jung, Klaus; Bergau, Leonard; Dorenkamp, Marc; Lüthje, Lars; Sohns, Christian; Sossalla, Samuel T.; Fischer, Thomas H.; Hasenfuss, Gerd; Friede, Tim; Zabel, Markus

2016-01-01

Abstract Aims Implantable cardioverter-defibrillators (ICDs) have been shown to improve survival, although a considerable number of patients never receive therapy. Implantable cardioverter-defibrillators are routinely implanted regardless of sex. There is continuing controversy whether major outcomes differ between men and women. Methods and results In this retrospective single-centre study, 1151 consecutive patients (19% women) undergoing ICD implantation between 1998 and 2010 were followed for mortality and first appropriate ICD shock over 4.9 ± 2.7 years. Sex-related differences were investigated using multivariable Cox models adjusting for potential confounders. During follow-up, 318 patients died, a rate of 5.9% per year among men and 4.6% among women (uncorrected P = 0.08); 266 patients received a first appropriate ICD shock (6.3% per year among men vs. 3.6% among women, P = 0.002). After multivariate correction, independent predictors of all-cause mortality were age (hazard ratio, HR = 1.04 per year of age, 95% confidence interval (CI) [1.03–1.06], P < 0.001), left ventricular ejection fraction (HR = 0.98 per %, 95% CI [0.97–1.00], P = 0.025), renal function (HR = 0.99 per mL/min/1.73 m2, 95% CI [0.99–1.00], P = 0.009), use of diuretics (HR = 1.81, 95% CI [1.29–2.54], P = 0.0023), peripheral arterial disease (HR = 2.21, 95% CI [1.62–3.00], P < 0.001), and chronic obstructive pulmonary disease (HR = 1.48, 95% CI [1.13–1.94], P = 0.029), but not sex. Female sex (HR = 0.51, 95% CI [0.33–0.81], P = 0.013), older age (HR = 0.98, 95% CI [0.97–0.99], P < 0.001), and primary prophylactic ICD indication (HR = 0.69, 95% CI [0.52–0.93], P = 0.043) were independent predictors for less appropriate shocks. Conclusion Women receive 50% less appropriate shocks than men having similar mortality in this large single-centre population. These data may pertain to individually improved selection of defibrillator candidates using risk factors, e.g. sex as

Can machine learning complement traditional medical device surveillance? A case study of dual-chamber implantable cardioverter-defibrillators.

PubMed

Ross, Joseph S; Bates, Jonathan; Parzynski, Craig S; Akar, Joseph G; Curtis, Jeptha P; Desai, Nihar R; Freeman, James V; Gamble, Ginger M; Kuntz, Richard; Li, Shu-Xia; Marinac-Dabic, Danica; Masoudi, Frederick A; Normand, Sharon-Lise T; Ranasinghe, Isuru; Shaw, Richard E; Krumholz, Harlan M

2017-01-01

Machine learning methods may complement traditional analytic methods for medical device surveillance. Using data from the National Cardiovascular Data Registry for implantable cardioverter-defibrillators (ICDs) linked to Medicare administrative claims for longitudinal follow-up, we applied three statistical approaches to safety-signal detection for commonly used dual-chamber ICDs that used two propensity score (PS) models: one specified by subject-matter experts (PS-SME), and the other one by machine learning-based selection (PS-ML). The first approach used PS-SME and cumulative incidence (time-to-event), the second approach used PS-SME and cumulative risk (Data Extraction and Longitudinal Trend Analysis [DELTA]), and the third approach used PS-ML and cumulative risk (embedded feature selection). Safety-signal surveillance was conducted for eleven dual-chamber ICD models implanted at least 2,000 times over 3 years. Between 2006 and 2010, there were 71,948 Medicare fee-for-service beneficiaries who received dual-chamber ICDs. Cumulative device-specific unadjusted 3-year event rates varied for three surveyed safety signals: death from any cause, 12.8%-20.9%; nonfatal ICD-related adverse events, 19.3%-26.3%; and death from any cause or nonfatal ICD-related adverse event, 27.1%-37.6%. Agreement among safety signals detected/not detected between the time-to-event and DELTA approaches was 90.9% (360 of 396, k =0.068), between the time-to-event and embedded feature-selection approaches was 91.7% (363 of 396, k =-0.028), and between the DELTA and embedded feature selection approaches was 88.1% (349 of 396, k =-0.042). Three statistical approaches, including one machine learning method, identified important safety signals, but without exact agreement. Ensemble methods may be needed to detect all safety signals for further evaluation during medical device surveillance.

Can machine learning complement traditional medical device surveillance? A case study of dual-chamber implantable cardioverter–defibrillators

PubMed Central

Ross, Joseph S; Bates, Jonathan; Parzynski, Craig S; Akar, Joseph G; Curtis, Jeptha P; Desai, Nihar R; Freeman, James V; Gamble, Ginger M; Kuntz, Richard; Li, Shu-Xia; Marinac-Dabic, Danica; Masoudi, Frederick A; Normand, Sharon-Lise T; Ranasinghe, Isuru; Shaw, Richard E; Krumholz, Harlan M

2017-01-01

Background Machine learning methods may complement traditional analytic methods for medical device surveillance. Methods and results Using data from the National Cardiovascular Data Registry for implantable cardioverter–defibrillators (ICDs) linked to Medicare administrative claims for longitudinal follow-up, we applied three statistical approaches to safety-signal detection for commonly used dual-chamber ICDs that used two propensity score (PS) models: one specified by subject-matter experts (PS-SME), and the other one by machine learning-based selection (PS-ML). The first approach used PS-SME and cumulative incidence (time-to-event), the second approach used PS-SME and cumulative risk (Data Extraction and Longitudinal Trend Analysis [DELTA]), and the third approach used PS-ML and cumulative risk (embedded feature selection). Safety-signal surveillance was conducted for eleven dual-chamber ICD models implanted at least 2,000 times over 3 years. Between 2006 and 2010, there were 71,948 Medicare fee-for-service beneficiaries who received dual-chamber ICDs. Cumulative device-specific unadjusted 3-year event rates varied for three surveyed safety signals: death from any cause, 12.8%–20.9%; nonfatal ICD-related adverse events, 19.3%–26.3%; and death from any cause or nonfatal ICD-related adverse event, 27.1%–37.6%. Agreement among safety signals detected/not detected between the time-to-event and DELTA approaches was 90.9% (360 of 396, k=0.068), between the time-to-event and embedded feature-selection approaches was 91.7% (363 of 396, k=−0.028), and between the DELTA and embedded feature selection approaches was 88.1% (349 of 396, k=−0.042). Conclusion Three statistical approaches, including one machine learning method, identified important safety signals, but without exact agreement. Ensemble methods may be needed to detect all safety signals for further evaluation during medical device surveillance. PMID:28860874

Comparison of pharmacological treatment alone vs. treatment combined with implantable cardioverter defibrillator therapy in patients older than 75 years.

PubMed

Cortés, Marcelino; Palfy, Julia Anna; Lopez, Marta; Martínez, Juan; Rivero, Ana Lucia; Devesa, Ana; Franco-Peláez, Juan Antonio; Briongos, Sem; Taibo-Urquia, Mikel; Benezet, Juan; Rubio, Jose-Manuel

2018-06-24

Implantable cardioverter defibrillator (ICD) reduces mortality in selected patients. However, its role in patients older than 75 years is not well established. We performed a retrospective, non-randomized study using a historical cohort from a single centre. Between January 2008 and July 2014, we assessed patients aged ≥75 years with left ventricular ejection fraction ≤ 35%, identifying 385 patients with a Class I or IIa recommendation for ICD implantation. At the decision of the patient or attending cardiologists, 92 patients received an ICD. To avoid potential confounding factors, we used propensity-score matching. Finally, 126 patients were included (63 with ICD). The mean age was 79.1 ± 3.1 years (86.5% male). As compared with the medical therapy group, the ICD patients had a lower percentage of chronic obstructive pulmonary disease (19.0% vs. 38.1%, P < 0.05) and more frequent use of beta-blockers (BBs) (85.7 vs. 70.0%, P < 0.05). Other treatments were otherwise similar in both groups. There were no differences related to age, aetiology, or other co-morbidities. During follow-up (39.2 ± 22.4 months), total mortality was 46.0% and cardiovascular events (death or hospitalization) occurred in 66.7% of the patients. A multivariate analysis revealed that only BB therapy was shown to be an independent protective variable with respect to mortality [hazard ratio 0.4 (0.2-0.7)]. ICD therapy did not reduce overall mortality or the rate of cardiovascular events. According to our results, the use of ICD, as compared with medical therapy, in patients older than 75 years did not demonstrate any benefit. Well-designed randomized controlled studies in patients older than 75 years are needed to ascertain the value of ICD therapy. © 2018 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.

Implantable cardioverter-defibrillator explantation for overdiagnosed or overtreated congenital long QT syndrome.

PubMed

Gaba, Prakriti; Bos, J Martijn; Cannon, Bryan C; Cha, Yong-Mei; Friedman, Paul A; Asirvatham, Samuel J; Ackerman, Michael J

2016-04-01

Primary treatment of long QT syndrome (LQTS) currently consists of beta-blocker therapy, although an implantable cardioverter-defibrillator (ICD) is considered for high-risk patients. However, both overdiagnosis and overtreatment must be avoided because their sequelae can be significant. The purpose of this study was to evaluate the prevalence and details of ICD explants in a cohort of patients from a tertiary genetic heart rhythm clinic for a previously rendered diagnosis of LQTS. Overall, 1227 consecutive patients were included in the study. All patients had been referred to the Mayo Clinic for evaluation of possible LQTS and subsequently were either diagnosed with LQTS or dismissed as normal. Further stratification of patients was conducted to assess how many patients had an ICD and how many had a subsequent ICD explant. In total, 170 patients (14%) had an ICD, including 157 of 670 patients (23%) with confirmed LQTS and 13 of 557 patients (2%) who did not have LQTS. Among these, 12 of 1227 (1%) had the ICD removed: 7 of 157 LQTS patients (4.5%) compared to 5 of 14 non-LQTS patients (36%). Before explant, 5 of 12 patients (42%) experienced inappropriate shocks, ranging from 2 to as many as 54 shocks. In addition, 4 had a device-related infection, and 9 had device malfunction (including lead dysfunction or fracture). None of these patients had a breakthrough cardiac event since removal of their ICD during 5.5 ± 3.5 years of follow-up. Implications of overdiagnosis and overtreatment are profound because unnecessary ICD placement can be associated with infection, malfunction, inappropriate shocks, and subsequent anxiety. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Characterization and predictors of first and subsequent inappropriate ICD therapy by heart rate ranges: Result of the MADIT-RIT efficacy analysis.

PubMed

Kutyifa, Valentina; Daubert, James P; Olshansky, Brian; Huang, David T; Zhang, Claire; Ruwald, Anne-Christine H; McNitt, Scott; Zareba, Wojciech; Moss, Arthur J; Schuger, Claudio

2015-09-01

Data on inappropriate implantable cardioverter-defibrillator (ICD) therapy and effects of programming by heart rate are lacking. We aimed to characterize inappropriate ICD therapy and assess the effects of novel programming by heart rate. Incidence and causes of inappropriate therapy by heart rate range (below or above 200 bpm) were assessed. Predictors of inappropriate therapy and effects of programming by heart rate were evaluated with multivariate Cox regression models. Crossovers were excluded. Inappropriate therapy occurred in 9.2% of the total patient population, with 19% of patients randomized to study arm A, 3.6% in arm B, and 4.7% in arm C. Inappropriate therapies <200 bpm were attributable to supraventricular tachycardia (SVT)/sinus tachycardia (78%) or atrial fibrillation/flutter (20%). Inappropriate therapy ≥200 bpm occurred because of SVT (47%), atrial fibrillation/flutter (41%), or electromagnetic interference (13%). Conventional ICD programming was associated with more inappropriate therapy <200 bpm than high-rate or delayed therapy, as were younger age, history of atrial arrhythmia, advanced New York Heart Association functional class, ICD versus cardiac resynchronization therapy with defibrillator, and absence of diabetes. High-rate and long-delay therapy significantly reduced the risk of inappropriate therapy in the <200 bpm range. Long delay was associated with further reduction of fast (≥200 bpm) inappropriate therapy (P = .032) and a reduction in subsequent inappropriate episodes (P = .006). In MADIT-RIT, inappropriate ICD therapy is most frequent at rates below 200 bpm and can be predicted, and effectively prevented, with high-rate cutoff programming. Long-delay therapy effectively reduces fast inappropriate therapy ≥200 bpm and subsequent events. [ http://clinicaltrials.gov/ct2/show/NCT00947310]. Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

ICD-10 classification in Danish child and adolescent psychiatry--have diagnoses changed after the introduction of ICD-10?

PubMed

Møller, Lene Ruge; Sørensen, Merete Juul; Thomsen, Per Hove

2007-01-01

The aim was to test this in a nationwide register study of diagnoses used in child and adolescents psychiatry in Denmark. A larger number of different diagnoses were expected to be applied after the introduction of the 10th version of the International Classification of Diseases (ICD-10). Reflecting the time trend, we particularly expected an increase in the number of neuropsychiatric diagnoses. From the Danish Psychiatric Central Register data were drawn on clinical discharge diagnoses. All patients aged 0-15 years examined at psychiatric hospitals from 1995-2002 were included; 22,469 children and adolescents with a first contact were registered. The most frequent discharge diagnoses were pervasive development disorders (PDD; 11.9%), adjustment disorders (10.6%), conduct disorder (9.5%), emotional and anxiety disorders (7.6%), hyperkinetic disorders (7.3%), and specific developmental disorders (7.3%). We found a significant increase in the number of neuropsychiatric and affective diagnoses and a significant decrease in the number of adjustment, conduct and anxiety diagnoses during the study period. Of the 22,469 diagnoses, 45% were only partly specified according to ICD-10. Thirty-four per cent had diagnoses unspecified on the four-character level (Fxx.9) and 11% had Z-diagnoses. A larger number of different diagnoses and an increase in the use of neuropsychiatric diagnoses were seen after the introduction of ICD-10. Many diagnoses were only partly specified; consequently, a more detailed specification of the ICD-10 is still required.

Implantable cardiac defibrillators and sudden death in recent onset nonischemic cardiomyopathy: results from IMAC2.

PubMed

Sheppard, Richard; Mather, Paul J; Alexis, Jeffrey D; Starling, Randall C; Boehmer, John P; Thohan, Vinay; Pauly, Daniel F; Markham, David W; Zucker, Mark; Kip, Kevin E; McNamara, Dennis M

2012-09-01

Given the potential for recovery in recent onset nonischemic cardiomyopathy (ROCM), the timing and need for implantable cardioverter-defibrillator (ICDs) remains controversial. We examined the utilization of ICDs and the impact on survival for subjects with ROCM. An National Heart, Lung, and Blood Institute sponsored registry enrolled 373 subjects with ROCM, all with a left ventricular ejection fraction (LVEF) ≤0.40 and ≤6 months of symptoms. The mean age was 45 ± 14 years, 38% were female, 21% black, 75% New York Heart Association II/III, and the mean LVEF was 0.24 ± 0.08. Survival was comparable for subjects with an ICD within 1 month of entry (n = 43, 1/2/3 year % survival = 97/97/92) and those with no ICD at 1 month (n = 330, % survival = 98/97/95, P = .30) and between those with and without an ICD at 6 months (ICD, n = 73, 1/2/3 year % survival = 98/98/95; no ICD, n = 300, % survival = 98/96/95, P = .95). There were only 6 sudden cardiac deaths (SCD) noted (% survival free from SCD = 99/98/97) and these occurred in 1.9% of subjects without ICD and 0.9% of those with a device (P = .50). In a multicenter cohort of ROCM the risk of SCD was low at 1% per year. Early ICD placement did not impact survival and can be deferred while assessing potential for myocardial recovery. Copyright © 2012 Elsevier Inc. All rights reserved.

Digital music players cause interference with interrogation telemetry for pacemakers and implantable cardioverter-defibrillators without affecting device function.

PubMed

Webster, Gregory; Jordao, Ligia; Martuscello, Maria; Mahajan, Tarun; Alexander, Mark E; Cecchin, Frank; Triedman, John K; Walsh, Edward P; Berul, Charles I

2008-04-01

Concern exists regarding the potential electromagnetic interaction between pacemakers, implantable cardioverter-defibrillators (ICDs) and digital music players (DMPs). A preliminary study reported interference in 50% of patients whose devices were interrogated near Apple iPods. Given the high prevalence of DMP use among young patients, we sought to define the nature of interference from iPods and evaluate other DMPs. Four DMPs (Apple Nano, Apple Video, SanDisk Sansa and Microsoft Zune) were evaluated against pacemakers and ICDs (PM/ICD). Along with continuous monitoring, we recorded a baseline ECG strip, sensing parameters and lead impedance at baseline and for each device. Among 51 patients evaluated (age 6 to 60 years, median 22), there was no interference with intrinsic device function. Interference with the programmer occurred in 41% of the patients. All four DMPs caused programmer interference, including disabled communication between the PM/ICD and programmer, noise in the ECG channel, and lost marker channel indicators. Sensing parameters and lead impedances exhibited no more than baseline variability. When the DMPs were removed six inches, there were no further programmer telemetry interactions. Contrary to a prior report, we did not identify any evidence for electromagnetic interference between a selection of DMPs and intrinsic function of PM/ICDs. The DMPs did sometimes interfere with device-programmer communication, but not in a way that compromised device function. Therefore, we recommend that DMPs not be used during device interrogation, but suggest that there is reassuring counterevidence to mitigate the current high level of concern for interactions between DMPs and implantable cardiac rhythm devices.

Harmonisation of ICD-11 and DSM-V: opportunities and challenges.

PubMed

First, Michael B

2009-11-01

Differences in the ICD-10 and DSM-IV definitions for the same disorder impede international communication and research efforts. The forthcoming parallel development of DSM-V and ICD-11 offers an opportunity to harmonise the two classifications. This paper aims to facilitate the harmonisation process by identifying diagnostic differences between the two systems. DSM-IV-TR criteria sets and the ICD-10 Diagnostic Criteria for Research were compared and categorised into those with identical definitions, those with conceptually based differences and those in which differences are not conceptually based and appear to be unintentional. Of the 176 criteria sets in both systems, only one, transient tic disorder, is identical. Twenty-one per cent had conceptually based differences and 78% had non-conceptually based differences. Harmonisation of criteria sets, especially those with non-conceptually based differences, should be prioritised in the DSM-V and ICD-11 development process. Prior experience with the DSM-IV and ICD-10 harmonisation effort suggests that for the process to be successful steps should be taken as early as possible.

Clashing Diagnostic Approaches: DSM-ICD versus RDoC

PubMed Central

Lilienfeld, Scott O.; Treadway, Michael T.

2016-01-01

Since at least the middle of the past century, one overarching model of psychiatric classification, namely, that of the Diagnostic and Statistical Manual of Mental Disorders and International Classification of Diseases (DSM-ICD), has reigned supreme. This DSM-ICD approach embraces an Aristotelian view of mental disorders as largely discrete entities that are characterized by distinctive signs, symptoms, and natural histories. Over the past several years, however, a competing vision, namely, the Research Domain Criteria (RDoC) initiative launched by the National Institute of Mental Health, has emerged in response to accumulating anomalies within the DSM-ICD system. In contrast to DSM-ICD, RDoC embraces a Galilean view of psychopathology as the product of dysfunctions in neural circuitry. RDoC appears to be a valuable endeavor that holds out the long-term promise of an alternative system of mental illness classification. We delineate three sets of pressing challenges – conceptual, methodological, and logistical/pragmatic – that must be addressed for RDoC to realize its scientific potential, and conclude with a call for further research, including investigation of a rapprochement between Aristotelian and Galilean approaches to psychiatric classification. PMID:26845519

Stereotyped movement disorder in ICD-11.

PubMed

Stein, Dan J; Woods, Douglas W

2014-01-01

According to current proposals for ICD-11, stereotyped movement disorder will be classified in the grouping of neurodevelopmental disorders, with a qualifier to indicate whether self-injury is present, similar to the classification of stereotypic movement disorder in DSM-5. At the same time, the WHO ICD-11 Working Group on the Classification of Obsessive-Compulsive and Related Disorders has proposed a grouping of body-focused repetitive behavior disorders within the obsessive-compulsive and related disorders (OCRD) cluster to include trichotillomania and skin-picking disorder. DSM-5 has taken a slightly different approach: trichotillomania and excoriation (skin picking) disorder are included in the OCRD grouping, while body-focused repetitive behavior disorder is listed under other specified forms of OCRD. DSM-5 also includes a separate category of nonsuicidal self-injury in the section on "conditions for further study." There are a number of unresolved nosological questions regarding the relationships among stereotyped movement disorder, body-focused repetitive behavior disorders, and nonsuicidal self-injury. In this article, we attempt to provide preliminary answers to some of these questions as they relate to the ICD-11 classification of mental and behavioral disorders.

Validation of ICD-9 Codes for Stable Miscarriage in the Emergency Department.

PubMed

Quinley, Kelly E; Falck, Ailsa; Kallan, Michael J; Datner, Elizabeth M; Carr, Brendan G; Schreiber, Courtney A

2015-07-01

International Classification of Disease, Ninth Revision (ICD-9) diagnosis codes have not been validated for identifying cases of missed abortion where a pregnancy is no longer viable but the cervical os remains closed. Our goal was to assess whether ICD-9 code "632" for missed abortion has high sensitivity and positive predictive value (PPV) in identifying patients in the emergency department (ED) with cases of stable early pregnancy failure (EPF). We studied females ages 13-50 years presenting to the ED of an urban academic medical center. We approached our analysis from two perspectives, evaluating both the sensitivity and PPV of ICD-9 code "632" in identifying patients with stable EPF. All patients with chief complaints "pregnant and bleeding" or "pregnant and cramping" over a 12-month period were identified. We randomly reviewed two months of patient visits and calculated the sensitivity of ICD-9 code "632" for true cases of stable miscarriage. To establish the PPV of ICD-9 code "632" for capturing missed abortions, we identified patients whose visits from the same time period were assigned ICD-9 code "632," and identified those with actual cases of stable EPF. We reviewed 310 patient records (17.6% of 1,762 sampled). Thirteen of 31 patient records assigned ICD-9 code for missed abortion correctly identified cases of stable EPF (sensitivity=41.9%), and 140 of the 142 patients without EPF were not assigned the ICD-9 code "632"(specificity=98.6%). Of the 52 eligible patients identified by ICD-9 code "632," 39 cases met the criteria for stable EPF (PPV=75.0%). ICD-9 code "632" has low sensitivity for identifying stable EPF, but its high specificity and moderately high PPV are valuable for studying cases of stable EPF in epidemiologic studies using administrative data.

Operating microscope light-induced phototoxic maculopathy after transscleral sutured posterior chamber intraocular lens implantation.

PubMed

Kweon, Eui Yong; Ahn, Min; Lee, Dong Wook; You, In Cheon; Kim, Min Jung; Cho, Nam Chun

2009-01-01

The purpose of this study is to report the features of operating microscope light-induced retinal phototoxic maculopathy after transscleral sutured posterior chamber intraocular lens (TSS PC-IOL) implantation. The charts of 118 patients who underwent TSS PC-IOL implantation surgery at Chonbuk National University Hospital (Jeonju, Korea) between March 1999 and February 2008 were retrospectively reviewed. Fourteen patients underwent combined 3-port pars plana vitrectomy and TSS PC-IOL implantation (vitrectomy group), and 104 patients underwent TSS PC-IOL implantation only (nonvitrectomy group). All surgeries were performed under the same coaxial illuminated microscope. All diagnoses were confirmed through careful fundus examination and fluorescein angiography (FA). Diagnoses of retinal phototoxic maculopathy were established in 10 (8.47%) of 118 TSS PC-IOL implantation cases. Phototoxic maculopathy occurred more frequently in the vitrectomy group than in the nonvitrectomy group (6/14 versus 4/104, respectively; P < 0.001, chi-square = 24.21). Affected patients reported decreased vision and were found to have coarse alterations of the retinal pigment epithelium (RPE). In 5 of the phototoxic maculopathy cases (50%), the visual acuity was 20/200 or worse. Operating microscope light-induced retinal phototoxic maculopathy can occur more frequently after TSS PC-IOL implantation than after casual cataract surgery, especially when TSS PC-IOL is combined with vitrectomy surgery. Surgeons should take precautions to prevent retinal phototoxicity after TSS PC-IOL implantation and vitrectomy.

Position paper for management of elderly patients with pacemakers and implantable cardiac defibrillators Groupe de rythmologie et stimulation cardiaque de la Société française de cardiologie et Société française de gériatrie et gérontologie.

PubMed

Fauchier, Laurent; Alonso, Christine; Anselme, Frédéric; Blangy, Hugues; Bordachar, Pierre; Boveda, Serge; Clementy, Nicolas; Defaye, Pascal; Deharo, Jean-Claude; Friocourt, Patrick; Gras, Daniel; Halimi, Franck; Klug, Didier; Mansourati, Jacques; Obadia, Benjamin; Pasquié, Jean-Luc; Pavin, Dominique; Sadoul, Nicolas; Taieb, Jérôme; Piot, Olivier; Hanon, Olivier

2016-09-01

Despite the increasingly high rate of implantation of pacemakers (PM) and cardioverter-defibrillators (ICD) in elderly patients, data supporting their clinical and cost-effectiveness in this age stratum are ambiguous and contradictory. We reviewed the data regarding the applicability, safety, and effectiveness of the conventional pacing, ICD and cardiac resynchronization therapy (CRT) in elderly patients. Although peri-procedural risk may be slightly higher in the elderly, the procedure of implantation of PMs and ICDs is still relatively safe in this age group. In older patients with sinus node disease, a general consensus is that dual chamber pacing, along with the programming of an algorithm to minimise ventricular pacing is preferred. In very old patients presenting with intermittent or suspected AV block, VVI pacing may be appropriate. In terms of correcting potentially life-threatening arrhythmias, the effectiveness of ICD therapy is comparable in older and younger individuals. However, the assumption of persistent ICD benefit in the elderly population is questionable, as any advantage of the device on arrhythmic death may be attenuated by a higher total non-arrhythmic mortality. While septuagenarians and octogenarians have higher annual all-cause mortality rates, ICD therapy may remain effective in selected patients at high risk of arrhythmic death and with minimum comorbidities despite advanced age. ICD implantation among the elderly, as a group, may not be cost-effective, but the procedure may reach cost-effectiveness in those expected to live >5-7 years after implantation. The elderly patients usually experience a significant functional improvement after CRT, similar to that observed in middle-aged patients. Management of CRT non responders remains globally the same, while considering a less aggressive approach in terms of re interventions (revision of LV lead placement, addition of a RV or LV lead, LV endocardial pacing configuration). Overall, age

Safety and interaction of patients with implantable cardiac defibrillators driving a hybrid vehicle.

PubMed

Tondato, Fernando; Bazzell, Jane; Schwartz, Linda; Mc Donald, Bruce W; Fisher, Robert; Anderson, S Shawn; Galindo, Arcenio; Dueck, Amylou C; Scott, Luis R

2017-01-15

Electromagnetic interference (EMI) can affect the function of implantable cardioverter defibrillators (ICD). Hybrid electric vehicles (HEV) have increased popularity and are a potential source of EMI. Little is known about the in vivo effects of EMI generated by HEV on ICD. This study evaluated the in vivo interaction between EMI generated by HEV with ICD. Thirty patients (73±9 y/o; 80% male) with stable ICD function were exposed to EMI generated by a Toyota Prius Hybrid®. The vehicle was lifted above the ground, allowing safe changes in engine rotation and consequent variations in electromagnetic emission. EMI was measured (NARDA STS® model EHP-50C) and expressed in A/m (magnetic), Volts/m (electrical), and Hertz (frequency). Six positions were evaluated: driver, front passenger, right and left back seats, outside, at the back and front of the car. Each position was evaluated at idle, 30 mph, 60 mph and variable speeds (acceleration-deceleration-brake). All ICD devices were continuously monitored during the study. The levels of EMI generated were low (highest mean levels: 2.09A/m at right back seat at 30 mph; and 3.5V/m at driver seat at variable speeds). No episode of oversensing or inadvertent change in ICD programming was observed. It is safe for patients with ICD to interact with HEV. This is the first study to address this issue using an in vivo model. Further studies are necessary to evaluate the interaction of different models of HEV or electric engine with ICD or unipolar pacemakers. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

The development, evolution, and modifications of ICD-10: challenges to the international comparability of morbidity data.

PubMed

Jetté, Nathalie; Quan, Hude; Hemmelgarn, Brenda; Drosler, Saskia; Maass, Christina; Moskal, Lori; Paoin, Wansa; Sundararajan, Vijaya; Gao, Song; Jakob, Robert; Ustün, Bedihran; Ghali, William A

2010-12-01

The United States is about to make a major nationwide transition from ICD-9-CM coding of hospital discharges to ICD-10-CM, a country-specific modification of the World Health Organization's ICD-10. As this transition occurs, the WHO is already in the midst of developing ICD-11. Given this context, we undertook this review to discuss: (1) the history of the International Classification of Diseases (a core information "building block" for health systems everywhere) from its introduction to the current era of ICD-11 development; (2) differences across country-specific ICD-10 clinical modifications and the challenges that these differences pose to the international comparability of morbidity data; (3) potential strategic approaches to achieving better international ICD-11 comparability. A literature review and stakeholder consultation was carried out. The various ICD-10 clinical modifications (ICD-10-AM [Australia], ICD-10-CA [Canada], ICD-10-GM [Germany], ICD-10-TM [Thailand], ICD-10-CM [United States]) were compared. These ICD-10 modifications differ in their number of codes, chapters, and subcategories. Specific conditions are present in some but not all of the modifications. ICD-11, with a similar structure to ICD-10, will function in an electronic health records environment and also provide disease descriptive characteristics (eg, causal properties, functional impact, and treatment). The threat to the comparability of international clinical morbidity is growing with the development of many country-specific ICD-10 versions. One solution to this threat is to develop a meta-database including all country-specific modifications to ensure more efficient use of people and resources, decrease omissions and errors but most importantly provide a platform for future ICD updates.

Remote monitoring of implantable cardioverter-defibrillators. Problems and implications using a telemonitoring system.

PubMed

Siebermair, J; Clauss, S; Martens, E; Schuessler, F; Oversohl, N; Haserueck, N; Estner, H L; Kääb, S; Wakili, R

2015-04-01

The rising number of implantable devices has led to an increase in device-related workload, e.g., regular interrogation follow-up visits. Telemonitoring systems for implantable cardioverter-defibrillators (ICDs) seem to be a promising tool for reducing workload and costs, and they have the potential of optimizing patient care. However, issues such as practical functionality of ICD telemonitoring in daily routine may affect its broad implementation. The objective of this study was to evaluate potential problems during the implementation of a telemonitoring system, Medtronic CareLink™ (CL™) with respect to the installation and data transmission process. A total of 159 patients with ICDs who were equipped with the CL™ system were evaluated and followed up for 16 months regarding the success rate of the first data transmission via the telemonitoring system. In this cohort, a high rate of nontransmission of 23.9 % was observed after the 16-month follow-up. A detailed interview of these patients (no transmission) revealed that the main reasons for failed transmissions were due to the patients' loss of interest in the concept (approximately 50 %) as well as technical problems (approximately 25 %) with setting up the system. These results indicate that telemonitoring systems bear potential problems and that the evaluation of patient motivation and technical support options seems to play an important role in establishing the functionality of these systems.

Performance of 2014 NICE defibrillator implantation guidelines in heart failure risk stratification.

PubMed

Cubbon, Richard M; Witte, Klaus K; Kearney, Lorraine C; Gierula, John; Byrom, Rowenna; Paton, Maria; Sengupta, Anshuman; Patel, Peysh A; Mn Walker, Andrew; Cairns, David A; Rajwani, Adil; Hall, Alistair S; Sapsford, Robert J; Kearney, Mark T

2016-05-15

Define the real-world performance of recently updated National Institute for Health and Care Excellence guidelines (TA314) on implantable cardioverter-defibrillator (ICD) use in people with chronic heart failure. Multicentre prospective cohort study of 1026 patients with stable chronic heart failure, associated with left ventricular ejection fraction (LVEF) ≤45% recruited in cardiology outpatient departments of four UK hospitals. We assessed the capacity of TA314 to identify patients at increased risk of sudden cardiac death (SCD) or appropriate ICD shock. The overall risk of SCD or appropriate ICD shock was 2.1 events per 100 patient-years (95% CI 1.7 to 2.6). Patients meeting TA314 ICD criteria (31.1%) were 2.5-fold (95% CI 1.6 to 3.9) more likely to suffer SCD or appropriate ICD shock; they were also 1.5-fold (95% CI 1.1 to 2.2) more likely to die from non-cardiovascular causes and 1.6-fold (95% CI 1.1 to 2.3) more likely to die from progressive heart failure. Patients with diabetes not meeting TA314 criteria experienced comparable absolute risk of SCD or appropriate ICD shock to patients without diabetes who met TA314 criteria. Patients with ischaemic cardiomyopathy not meeting TA314 criteria experienced comparable absolute risk of SCD or appropriate ICD shock to patients with non-ischaemic cardiomyopathy who met TA314 criteria. TA314 can identify patients with reduced LVEF who are at increased relative risk of sudden death. Clinicians should also consider clinical context and the absolute risk of SCD when advising patients about the potential risks and benefits of ICD therapy. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Psychotic disorders in DSM-5 and ICD-11.

PubMed

Biedermann, Falko; Fleischhacker, W Wolfgang

2016-08-01

The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) was published by the American Psychiatric Association (APA) in 2013, and the Work Group on the Classification of Psychotic disorders (WGPD), installed by the World Health Organization (WHO), is expected to publish the new chapter about schizophrenia and other primary psychotic disorders in 2017. We reviewed the available literature to summarize the major changes, innovations, and developments of both manuals. If available and possible, we outline the theoretical background behind these changes. Due to the fact that the development of ICD-11 has not yet been completed, the details about ICD-11 are still proposals under ongoing revision. In this ongoing process, they may be revised and therefore have to be seen as proposals. DSM-5 has eliminated schizophrenia subtypes and replaced them with a dimensional approach based on symptom assessments. ICD-11 will most likely go in a similar direction, as both manuals are planned to be more harmonized, although some differences will remain in details and the conceptual orientation. Next to these modifications, ICD-11 will provide a transsectional diagnostic criterion for schizoaffective disorders and a reorganization of acute and transient psychotic and delusional disorders. In this manuscript, we will compare the 2 classification systems.

Body-focused repetitive behavior disorders in ICD-11.

PubMed

Grant, Jon E; Stein, Dan J

2014-01-01

This article addresses the question of how body-focused repetitive behavior disorders (e.g., trichotillomania and skin-picking disorder) should be characterized in ICD-11. The article reviews the historical nosology of the two disorders and the current approaches in DSM-5 and ICD-10. Although data are limited and mixed regarding the optimal relationship between body-focused repetitive behavior disorders and nosological categories, these conditions should be included within the obsessive-compulsive and related disorders category, as this is how most clinicians see these behaviors, and as this may optimize clinical utility. The descriptions of these disorders should largely mirror those in DSM-5, given the evidence from recent field surveys. The recommendations regarding ICD-11 and body-focused repetitive behavior disorders should promote the global identification and treatment of these conditions in primary care settings.

77 FR 48985 - Notice of Meeting of the ICD-9-CM Coordination and Maintenance Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-15

... Topics: ICD-10 Implementation Announcements Expansion of Thoracic Aorta Body Part Under Heart and Great... from thoracic aorta to abdominal aorta) ICD-10 MS-DRGs ICD-10 HAC Translations ICD-10 MCE Translations...

The Decisions, Interventions, and Goals in ImplaNtable Cardioverter-DefIbrillator TherapY (DIGNITY) Pilot Study.

PubMed

Kramer, Daniel B; Habtemariam, Daniel; Adjei-Poku, Yaw; Samuel, Michelle; Engorn, Diane; Reynolds, Matthew R; Mitchell, Susan L

2017-09-22

Implantable cardioverter-defibrillators (ICDs) are commonly implanted in older patients, including those with multiple comorbidities. There are few prospective studies assessing the clinical course and end-of-life circumstances for these patients. We prospectively followed 51 patients with ICDs for up to 18 months to longitudinally assess in terms of (1) advance care planning, (2) health status, (3) healthcare utilization, and (4) end-of-life circumstances through quarterly phone interviews and electronic medical record review. The mean age was 71.1±8.3, 74.5% were men, and 19.6% were non-white. Congestive heart failure was predominant (82.4%), as was chronic kidney disease (92%). At baseline, a total of 12% of subjects met criteria for major depression, and 78.4% met criteria for mild cognitive impairment. From this initial study cohort, 76% survived to 18 months and completed all follow-up interviews, 18% died, and 19% withdrew or were lost to follow-up. Though living will completion and healthcare proxy assignment were common (cumulative outcome at 18 months 88% and 98%, respectively), discussions of prognosis were uncommon (baseline, 9.8%; by 18 months, 22.7%), as were conversations regarding ICD deactivation (baseline, 15.7%; by 18 months, 25.5%). Five decedents with available data received shocks in the days immediately prior to death, including 3 of whom ultimately had their ICDs deactivated prior to death. We demonstrated the feasibility of prospective enrollment and follow-up of older, vulnerable ICD patients. Early findings suggest a high burden of cognitive and psychological impairment, poor communication with providers, and frequent shocks at the end of life. These findings will inform the design of a larger cohort study designed to further explore the experiences of living and dying with an ICD in this important patient population. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

ICD Complex Operations and Maintenance Plan

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

Gibson, P. L.

2007-06-25

This Operations and Maintenance (O&M) Plan describes how the Idaho National Laboratory (INL) conducts operations, winterization, and startup of the Idaho CERCLA Disposal Facility (ICDF) Complex. The ICDF Complex is the centralized INL facility responsible for the receipt, storage, treatment (as necessary), and disposal of INL Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) remediation waste.

Genome-wide association of implantable cardioverter-defibrillator activation with life-threatening arrhythmias.

PubMed

Murray, Sarah S; Smith, Erin N; Villarasa, Nikki; Nahey, Tara; Lande, Jeff; Goldberg, Harold; Shaw, Marian; Rosenthal, Lawrence; Ramza, Brian; Alaeddini, Jamshid; Han, Xinqiang; Damani, Samir; Soykan, Orhan; Kowal, Robert C; Topol, Eric J

2012-01-01

To identify genetic factors that would be predictive of individuals who require an implantable cardioverter-defibrillator (ICD), we conducted a genome-wide association study among individuals with an ICD who experienced a life-threatening arrhythmia (LTA; cases) vs. those who did not over at least a 3-year period (controls). Most individuals that receive implantable cardioverter-defibrillators never experience a life-threatening arrhythmia. Genetic factors may help identify who is most at risk. Patients with an ICD and extended follow-up were recruited from 34 clinical sites with the goal of oversampling those who had experienced LTA, with a cumulative 607 cases and 297 controls included in the analysis. A total of 1,006 Caucasian patients were enrolled during a time period of 13 months. Arrhythmia status of 904 patients could be confirmed and their genomic data were included in the analysis. In this cohort, there were 704 males, 200 females, and the average age was 73.3 years. We genotyped DNA samples using the Illumina Human660 W Genotyping BeadChip and tested for association between genotype at common variants and the phenotype of having an LTA. We did not find any associations reaching genome-wide significance, with the strongest association at chromosome 13, rs11856574 at P = 5×10⁻⁶. Loci previously implicated in phenotypes such as QT interval (measure of the time between the start of the Q wave and the end of the T wave as measured by electrocardiogram) were not found to be significantly associated with having an LTA. Although powered to detect such associations, we did not find common genetic variants of large effect associated with having a LTA in those of European descent. This indicates that common gene variants cannot be used at this time to guide ICD risk-stratification. ClinicalTrials.gov NCT00664807.

An evaluation of comparability between NEISS and ICD-9-CM injury coding.

PubMed

Thompson, Meghan C; Wheeler, Krista K; Shi, Junxin; Smith, Gary A; Xiang, Huiyun

2014-01-01

To evaluate the National Electronic Injury Surveillance System's (NEISS) comparability with a data source that uses ICD-9-CM coding. A sample of NEISS cases from a children's hospital in 2008 was selected, and cases were linked with their original medical record. Medical records were reviewed and an ICD-9-CM code was assigned to each case. Cases in the NEISS sample that were non-injuries by ICD-9-CM standards were identified. A bridging matrix between the NEISS and ICD-9-CM injury coding systems, by type of injury classification, was proposed and evaluated. Of the 2,890 cases reviewed, 13.32% (n = 385) were non-injuries according to the ICD-9-CM diagnosis. Using the proposed matrix, the comparability of the NEISS with ICD-9-CM coding was favorable among injury cases (κ = 0.87, 95% CI: 0.85-0.88). The distribution of injury types among the entire sample was similar for the two systems, with percentage differences ≥1% for only open wounds or amputation, poisoning, and other or unspecified injury types. There is potential for conducting comparable injury research using NEISS and ICD-9-CM data. Due to the inclusion of some non-injuries in the NEISS and some differences in type of injury definitions between NEISS and ICD-9-CM coding, best practice for studies using NEISS data obtained from the CPSC should include manual review of case narratives. Use of the standardized injury and injury type definitions presented in this study will facilitate more accurate comparisons in injury research.

Influence of ion source configuration and its operation parameters on the target sputtering and implantation process.

PubMed

Shalnov, K V; Kukhta, V R; Uemura, K; Ito, Y

2012-06-01

In the work, investigation of the features and operation regimes of sputter enhanced ion-plasma source are presented. The source is based on the target sputtering with the dense plasma formed in the crossed electric and magnetic fields. It allows operation with noble or reactive gases at low pressure discharge regimes, and, the resulting ion beam is the mixture of ions from the working gas and sputtering target. Any conductive material, such as metals, alloys, or compounds, can be used as the sputtering target. Effectiveness of target sputtering process with the plasma was investigated dependently on the gun geometry, plasma parameters, and the target bias voltage. With the applied accelerating voltage from 0 to 20 kV, the source can be operated in regimes of thin film deposition, ion-beam mixing, and ion implantation. Multi-component ion beam implantation was applied to α-Fe, which leads to the surface hardness increasing from 2 GPa in the initial condition up to 3.5 GPa in case of combined N(2)-C implantation. Projected range of the implanted elements is up to 20 nm with the implantation energy 20 keV that was obtained with XPS depth profiling.

A self-report measure for the ICD-11 dimensional trait model proposal: The personality inventory for ICD-11.

PubMed

Oltmanns, Joshua R; Widiger, Thomas A

2018-02-01

Proposed for the 11th edition of the World Health Organization's International Classification of Diseases (ICD-11) is a dimensional trait model for the classification of personality disorder (Tyrer, Reed, & Crawford, 2015). The ICD-11 proposal consists of 5 broad domains: negative affective, detachment, dissocial, disinhibition, and anankastic (Mulder, Horwood, Tyrer, Carter, & Joyce, 2016). Several field trials have examined this proposal, yet none has included a direct measure of the trait model. The purpose of the current study was to develop and provide initial validation for the Personality Inventory for ICD-11 (PiCD), a self-report measure of this proposed 5-domain maladaptive trait model. Item selection and scale construction proceeded through 3 initial data collections assessing potential item performance. Two subsequent studies were conducted for scale validation. In Study 1, the PiCD was evaluated in a sample of 259 MTurk participants (who were or had been receiving mental health treatment) with respect to 2 measures of general personality structure: The Eysenck Personality Questionnaire-Revised and the 5-Dimensional Personality Test. In Study 2, the PiCD was evaluated in an additional sample of 285 participants with respect to 2 measures of maladaptive personality traits: The Personality Inventory for DSM-5 and the Computerized Adaptive Test for Personality Disorders. Study 3 provides an item-level exploratory structural equation model with the combined samples from Studies 1 and 2. The results are discussed with respect to the validity of the measure and the potential benefits for future research in having a direct, self-report measure of the ICD-11 trait proposal. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Ambient temperature and activation of implantable cardioverter defibrillators

NASA Astrophysics Data System (ADS)

McGuinn, L.; Hajat, S.; Wilkinson, P.; Armstrong, B.; Anderson, H. R.; Monk, V.; Harrison, R.

2013-09-01

The degree to which weather influences the occurrence of serious cardiac arrhythmias is not fully understood. To investigate, we studied the timing of activation of implanted cardiac defibrillators (ICDs) in relation to daily outdoor temperatures using a fixed stratum case-crossover approach. All patients attending ICD clinics in London between 1995 and 2003 were recruited onto the study. Temperature exposure for each ICD patient was determined by linking each patient's postcode of residence to their nearest temperature monitoring station in London and the South of England. There were 5,038 activations during the study period. Graphical inspection of ICD activation against temperature suggested increased risk at lower but not higher temperatures. For every 1 °C decrease in ambient temperature, risk of ventricular arrhythmias up to 7 days later increased by 1.2 % (95 % CI -0.6 %, 2.9 %). In threshold models, risk of ventricular arrhythmias increased by 11.2 % (0.5 %, 23.1 %) for every 1° decrease in temperature below 2 °C. Patients over the age of 65 exhibited the highest risk. This large study suggests an inverse relationship between ambient outdoor temperature and risk of ventricular arrhythmias. The highest risk was found for patients over the age of 65. This provides evidence about a mechanism for some cases of low-temperature cardiac death, and suggests a possible strategy for reducing risk among selected cardiac patients by encouraging behaviour modification to minimise cold exposure.

Analysis of implantable defibrillator longevity under clinical circumstances: implications for device selection.

PubMed

Knops, Paul; Theuns, Dominic A M J; Res, Jan C J; Jordaens, Luc

2009-10-01

Information about implantable cardioverter-defibrillator (ICD) longevity is mostly calculated from measurements under ideal laboratory conditions. However, little information about longevity under clinical circumstances is available. This survey gives an overview on ICD service times and generator replacements in a cohort of consecutive ICD patients. Indications for replacement were classified as a normal end-of-service (EOS), premature EOS, system malfunction, infection and device advisory, or recall actions. From the premature and normal EOS group, longevity from single-chamber (SC), dual-chamber (DC), and cardiac resynchronization therapy defibrillator (CRT-D), rate-responsive (RR) settings, high output (HO) stimulation, and indication for ICD therapy was compared. Differences between brands were compared as well. In a total of 854 patients, 203 ICD replacements (165 patients) were recorded. Premature and normal EOS replacements consisted of 32 SC, 98 DC and 24 CRT-D systems. Longevity was significantly longer in SC systems compared to DC and CRT-D systems (54 +/- 19 vs. 40 +/- 17 and 42 +/- 15 months; P = 0.008). Longevity between non-RR (n = 143) and RR (n = 11) settings was not significantly different (43 +/- 18 vs. 45 +/- 13 months) as it also was not for HO versus non-HO stimulation (43 +/- 19 vs. 46 +/- 17 months). Longevity of ICDs was not significantly different between primary and secondary prevention (42 +/- 19 vs. 44 +/- 18 months). The average longevity on account of a device-based EOS message was 43 +/- 18 months. Average longevity for Biotronik (BIO, n = 72) was 33 +/- 10 months, for ELA Medical (ELA, n = 12) 44 +/- 17 months, for Guidant (GDT, n = 36) 49 +/- 12 months, for Medtronic (MDT, n = 29) 62 +/- 22 months, and for St. Jude Medical (SJM, n = 5) 31 +/- 9 months (P < 0.001). SC ICD generators had a longer service time compared to DC and CRT-D systems. No influence of indication for ICD therapy and HO stimulation on generator longevity was

Modified Wideband Three-Dimensional Late Gadolinium Enhancement MRI for Patients with Implantable Cardiac Devices

PubMed Central

Rashid, Shams; Rapacchi, Stanislas; Shivkumar, Kalyanam; Plotnik, Adam; Finn, J. Paul; Hu, Peng

2015-01-01

Purpose To study the effects of cardiac devices on three-dimensional (3D) late gadolinium enhancement (LGE) MRI and to develop a 3D LGE protocol for implantable cardioverter defibrillator (ICD) patients with reduced image artifacts. Theory and Methods The 3D LGE sequence was modified by implementing a wideband inversion pulse, which reduces hyperintensity artifacts, and by increasing bandwidth of the excitation pulse. The modified wideband 3D LGE sequence was tested in phantoms and evaluated in six volunteers and five patients with ICDs. Results Phantom and in vivo studies results demonstrated extended signal void and ripple artifacts in 3D LGE that were associated with ICDs. The reason for these artifacts was slab profile distortion and the subsequent aliasing in the slice-encoding direction. The modified wideband 3D LGE provided significantly reduced ripple artifacts than 3D LGE with wideband inversion only. Comparison of 3D and 2D LGE images demonstrated improved spatial resolution of the heart using 3D LGE. Conclusion Increased bandwidth of the inversion and excitation pulses can significantly reduce image artifacts associated with ICDs. Our modified wideband 3D LGE protocol can be readily used for imaging patients with ICDs given appropriate safety guidelines are followed. PMID:25772155

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

PubMed

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

2012-06-19

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

Using left-ventricular-only pacing to eliminate T-wave oversensing in a biventricular implantable cardiac defibrillator.

PubMed

Khoo, Clarence; Bennett, Matthew; Chakrabarti, Santabhanu; LeMaitre, John; Tung, Stanley K K

2013-02-01

A man aged 75 years and with nonischemic cardiomyopathy had implantation of a biventricular implantable cardiac defibrillator (ICD). Consistent biventricular pacing was limited by intermittent T-wave oversensing (TWOS). A strategy of left-ventricular-only pacing was used to eliminate TWOS. This strategy obviates the need to reduce ventricular sensitivity and thus may be an effective alternative to biventricular pacing complicated by TWOS. Copyright © 2013 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

Safety and Efficacy of Subcutaneous Cardioverter Defibrillator in Patients at High Risk of Sudden Cardiac Death　- Primary Japanese Experience.

PubMed

Sasaki, Shingo; Tomita, Hirofumi; Tsurugi, Takuo; Ishida, Yuji; Shoji, Yoshihiro; Nishizaki, Kimitaka; Kinjo, Takahiko; Endo, Tomohide; Nishizaki, Fumie; Hanada, Kenji; Sasaki, Kenichi; Horiuchi, Daisuke; Kimura, Masaomi; Higuma, Takumi; Okamatsu, Hideharu; Tanaka, Yasuaki; Koyama, Junjiroh; Okumura, Ken

2018-04-11

The entirely subcutaneous implantable cardioverter defibrillator (S-ICD) was introduced as a new alternative to conventional transvenous ICD (TV-ICD) in Japan in February 2016, but its safety and efficacy are unclear.Methods and Results:A total of 60 patients (48 men, median age, 60 years; IQR, 44-67 years; primary prevention, n=24) underwent S-ICD implantation between February 2016 and August 2017. The device pocket was formed in the intermuscular space between the serratus anterior muscle and the latissimus dorsi muscle, and the parasternal S-ICD lead was placed according to pre-implant screening. Defibrillation test was performed in 56 patients (93%). Ventricular fibrillation (VF) was induced in 55 patients and terminated by a single 65-J shock in all patients. The median time to shock therapy was 13.4 s (IQR, 12.1-14.9 s) and the median post-shock impedance of the S-ICD lead was 64 Ω (IQR, 58-77 Ω). There were no operation-related complications or subsequent infectious complications. During follow-up (median, 275 days; IQR, 107-421 days), 1 patient (1.7%) had appropriate shock for VF with successful termination, whereas 5 patients (8.3%) had inappropriate shock due to oversensing of myopotential (n=3) or T-wave (n=1), and detection of supraventricular tachycardia (n=1). S-ICD is a safe and effective alternative to conventional TV-ICD. The long-term safety and efficacy of the S-ICD need further investigation.

An Evaluation of Comparability between NEISS and ICD-9-CM Injury Coding

PubMed Central

Thompson, Meghan C.; Wheeler, Krista K.; Shi, Junxin; Smith, Gary A.; Xiang, Huiyun

2014-01-01

Objective To evaluate the National Electronic Injury Surveillance System’s (NEISS) comparability with a data source that uses ICD-9-CM coding. Methods A sample of NEISS cases from a children’s hospital in 2008 was selected, and cases were linked with their original medical record. Medical records were reviewed and an ICD-9-CM code was assigned to each case. Cases in the NEISS sample that were non-injuries by ICD-9-CM standards were identified. A bridging matrix between the NEISS and ICD-9-CM injury coding systems, by type of injury classification, was proposed and evaluated. Results Of the 2,890 cases reviewed, 13.32% (n = 385) were non-injuries according to the ICD-9-CM diagnosis. Using the proposed matrix, the comparability of the NEISS with ICD-9-CM coding was favorable among injury cases (κ = 0.87, 95% CI: 0.85–0.88). The distribution of injury types among the entire sample was similar for the two systems, with percentage differences ≥1% for only open wounds or amputation, poisoning, and other or unspecified injury types. Conclusions There is potential for conducting comparable injury research using NEISS and ICD-9-CM data. Due to the inclusion of some non-injuries in the NEISS and some differences in type of injury definitions between NEISS and ICD-9-CM coding, best practice for studies using NEISS data obtained from the CPSC should include manual review of case narratives. Use of the standardized injury and injury type definitions presented in this study will facilitate more accurate comparisons in injury research. PMID:24658100

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

PubMed

Akel, Tamer; Lafferty, James

2017-06-01

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

Relationship between right and left ventricular function in candidates for implantable cardioverter defibrillator with low left ventricular ejection fraction.

PubMed

Jimenez-Juan, Laura; Karur, Gauri R; Connelly, Kim A; Deva, Djeven; Yan, Raymond T; Wald, Rachel M; Singh, Sheldon; Leung, General; Oikonomou, Anastasia; Dorian, Paul; Angaran, Paul; Yan, Andrew T

2017-04-01

Indications for the primary prevention of sudden death using an implantable cardioverter defibrillator (ICD) are based predominantly on left ventricular ejection fraction (LVEF). However, right ventricular ejection fraction (RVEF) is also a known prognostic factor in a variety of structural heart diseases that predispose to sudden cardiac death. We sought to investigate the relationship between right and left ventricular parameters (function and volume) measured by cardiovascular magnetic resonance (CMR) among a broad spectrum of patients considered for an ICD. In this retrospective, single tertiary-care center study, consecutive patients considered for ICD implantation who were referred for LVEF assessment by CMR were included. Right and left ventricular function and volumes were measured. In total, 102 patients (age 62±14 years; 23% women) had a mean LVEF of 28±11% and RVEF of 44±12%. The left ventricular and right ventricular end diastolic volume index was 140±42 mL/m 2 and 81±27 mL/m 2 , respectively. Eighty-six (84%) patients had a LVEF <35%, and 63 (62%) patients had right ventricular systolic dysfunction. Although there was a significant and moderate correlation between LVEF and RVEF ( r =0.40, p <0.001), 32 of 86 patients (37%) with LVEF <35% had preserved RVEF, while 9 of 16 patients (56%) with LVEF ≥35% had right ventricular systolic dysfunction (Kappa=0.041). Among patients being considered for an ICD, there is a positive but moderate correlation between LVEF and RVEF. A considerable proportion of patients who qualify for an ICD based on low LVEF have preserved RVEF, and vice versa.

Effectiveness of prophylactic implantation of cardioverter-defibrillators without cardiac resynchronization therapy in patients with ischaemic or non-ischaemic heart disease: a systematic review and meta-analysis

PubMed Central

Theuns, Dominic A.M.J.; Smith, Tim; Hunink, Myriam G.M.; Bardy, Gust H.; Jordaens, Luc

2010-01-01

Aims Much controversy exists concerning the efficacy of primary prophylactic implantable cardioverter-defibrillators (ICDs) in patients with low ejection fraction due to coronary artery disease (CAD) or dilated cardiomyopathy (DCM). This is also related to the bias created by function improving interventions added to ICD therapy, e.g. resynchronization therapy. The aim was to investigate the efficacy of ICD-only therapy in primary prevention in patients with CAD or DCM. Methods and results Public domain databases, MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials, were searched from 1980 to 2009 for randomized clinical trials of ICD vs. conventional therapy. Two investigators independently abstracted the data. Pooled estimates were calculated using both fixed-effects and random-effects models. Eight trials were included in the final analysis (5343 patients). Implantable cardioverter-defibrillators significantly reduced the arrhythmic mortality [relative risk (RR): 0.40; 95% confidence interval (CI): 0.27–0.67] and all-cause mortality (RR: 0.73; 95% CI: 0.64–0.82). Regardless of aetiology of heart disease, ICD benefit was similar for CAD (RR: 0.67; 95% CI: 0.51–0.88) vs. DCM (RR: 0.74; 95% CI: 0.59–0.93). Conclusions The results of this meta-analysis provide strong evidence for the beneficial effect of ICD-only therapy on the survival of patients with ischaemic or non-ischaemic heart disease, with a left ventricular ejection fraction ≤35%, if they are 40 days from myocardial infarction and ≥3 months from a coronary revascularization procedure. PMID:20974768

Intracellular fragment of NLRR3 (NLRR3-ICD) stimulates ATRA-dependent neuroblastoma differentiation

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

Akter, Jesmin; Takatori, Atsushi, E-mail: atakatori@chiba-cc.jp; Islam, Md. Sazzadul

2014-10-10

Highlights: • NLRR3 is a membrane protein highly expressed in favorable neuroblastoma. • NLRR3-ICD was produced through proteolytic processing by secretases. • NLRR3-ICD was induced to be translocated into cell nucleus following ATRA exposure. • NLRR3-ICD plays a pivotal role in ATRA-mediated neuroblastoma differentiation. - Abstract: We have previously identified neuronal leucine-rich repeat protein-3 (NLRR3) gene which is preferentially expressed in favorable human neuroblastomas as compared with unfavorable ones. In this study, we have found for the first time that NLRR3 is proteolytically processed by secretases and its intracellular domain (NLRR3-ICD) is then released to translocate into cell nucleus duringmore » ATRA-mediated neuroblastoma differentiation. According to our present observations, NLRR3-ICD was induced to accumulate in cell nucleus of neuroblastoma SH-SY5Y cells following ATRA treatment. Since the proteolytic cleavage of NLRR3 was blocked by α- or γ-secretase inhibitor, it is likely that NLRR3-ICD is produced through the secretase-mediated processing of NLRR3. Intriguingly, forced expression of NLRR3-ICD in neuroblastoma SK-N-BE cells significantly suppressed their proliferation as examined by a live-cell imaging system and colony formation assay. Similar results were also obtained in neuroblastoma TGW cells. Furthermore, overexpression of NLRR3-ICD stimulated ATRA-dependent neurite elongation in SK-N-BE cells. Together, our present results strongly suggest that NLRR3-ICD produced by the secretase-mediated proteolytic processing of NLRR3 plays a crucial role in ATRA-mediated neuronal differentiation, and provide a clue to develop a novel therapeutic strategy against aggressive neuroblastomas.« less

Design, development and first validation of a transcoding system from ICD-9-CM to ICD-10 in the IT.DRG Italian project.

PubMed

Della Mea, Vincenzo; Vuattolo, Omar; Frattura, Lucilla; Munari, Flavia; Verdini, Eleonora; Zanier, Loris; Arcangeli, Laura; Carle, Flavia

2015-01-01

In Italy, ICD-9-CM is currently used for coding health conditions at hospital discharge, but ICD-10 is being introduced thanks to the IT-DRG Project. In this project, one needed component is a set of transcoding rules and associated tools for easing coders work in the transition. The present paper illustrates design and development of those transcoding rules, and their preliminary testing on a subset of Italian hospital discharge data.

Evidence of distinct profiles of Posttraumatic Stress Disorder (PTSD) and Complex Posttraumatic Stress Disorder (CPTSD) based on the new ICD-11 Trauma Questionnaire (ICD-TQ).

PubMed

Karatzias, Thanos; Shevlin, Mark; Fyvie, Claire; Hyland, Philip; Efthymiadou, Erifili; Wilson, Danielle; Roberts, Neil; Bisson, Jonathan I; Brewin, Chris R; Cloitre, Marylene

2017-01-01

The WHO International Classification of Diseases, 11th version (ICD-11), has proposed two related diagnoses following exposure to traumatic events; Posttraumatic Stress Disorder (PTSD) and Complex PTSD (CPTSD). We set out to explore whether the newly developed ICD-11 Trauma Questionnaire (ICD-TQ) can distinguish between classes of individuals according to the PTSD and CPTSD symptom profiles as per ICD-11 proposals based on latent class analysis. We also hypothesized that the CPTSD class would report more frequent and a greater number of different types of childhood trauma as well as higher levels of functional impairment. Methods Participants in this study were a sample of individuals who were referred for psychological therapy to a National Health Service (NHS) trauma centre in Scotland (N=193). Participants completed the ICD-TQ as well as measures of life events and functioning. Overall, results indicate that using the newly developed ICD-TQ, two subgroups of treatment-seeking individuals could be empirically distinguished based on different patterns of symptom endorsement; a small group high in PTSD symptoms only and a larger group high in CPTSD symptoms. In addition, CPTSD was more strongly associated with more frequent and a greater accumulation of different types of childhood traumatic experiences and poorer functional impairment. Sample predominantly consisted of people who had experienced childhood psychological trauma or been multiply traumatised in childhood and adulthood. CPTSD is highly prevalent in treatment seeking populations who have been multiply traumatised in childhood and adulthood and appropriate interventions should now be developed to aid recovery from this debilitating condition. Copyright © 2016 Elsevier B.V. All rights reserved.

Simultaneous bilateral stereotactic procedure for deep brain stimulation implants: a significant step for reducing operation time.

PubMed

Fonoff, Erich Talamoni; Azevedo, Angelo; Angelos, Jairo Silva Dos; Martinez, Raquel Chacon Ruiz; Navarro, Jessie; Reis, Paul Rodrigo; Sepulveda, Miguel Ernesto San Martin; Cury, Rubens Gisbert; Ghilardi, Maria Gabriela Dos Santos; Teixeira, Manoel Jacobsen; Lopez, William Omar Contreras

2016-07-01

OBJECT Currently, bilateral procedures involve 2 sequential implants in each of the hemispheres. The present report demonstrates the feasibility of simultaneous bilateral procedures during the implantation of deep brain stimulation (DBS) leads. METHODS Fifty-seven patients with movement disorders underwent bilateral DBS implantation in the same study period. The authors compared the time required for the surgical implantation of deep brain electrodes in 2 randomly assigned groups. One group of 28 patients underwent traditional sequential electrode implantation, and the other 29 patients underwent simultaneous bilateral implantation. Clinical outcomes of the patients with Parkinson's disease (PD) who had undergone DBS implantation of the subthalamic nucleus using either of the 2 techniques were compared. RESULTS Overall, a reduction of 38.51% in total operating time for the simultaneous bilateral group (136.4 ± 20.93 minutes) as compared with that for the traditional consecutive approach (220.3 ± 27.58 minutes) was observed. Regarding clinical outcomes in the PD patients who underwent subthalamic nucleus DBS implantation, comparing the preoperative off-medication condition with the off-medication/on-stimulation condition 1 year after the surgery in both procedure groups, there was a mean 47.8% ± 9.5% improvement in the Unified Parkinson's Disease Rating Scale Part III (UPDRS-III) score in the simultaneous group, while the sequential group experienced 47.5% ± 15.8% improvement (p = 0.96). Moreover, a marked reduction in the levodopa-equivalent dose from preoperatively to postoperatively was similar in these 2 groups. The simultaneous bilateral procedure presented major advantages over the traditional sequential approach, with a shorter total operating time. CONCLUSIONS A simultaneous stereotactic approach significantly reduces the operation time in bilateral DBS procedures, resulting in decreased microrecording time, contributing to the optimization of functional

Diaphragmatic Myopotential Oversensing Caused by Change in Implantable Cardioverter Defibrillator Sensing Bandpass Filter.

PubMed

Ploux, Sylvain; Swerdlow, Charles D; Eschalier, Romain; Monteil, Benjamin; Ouali, Sana; Haïssaguerre, Michel; Bordachar, Pierre

2016-07-01

Diaphragmatic myopotential oversensing (DMO) causes inhibition of pacing and inappropriate detection of ventricular fibrillation in implantable cardioverter defibrillators (ICDs). It occurs almost exclusively with integrated bipolar leads and is extremely rare with dedicated bipolar leads. If DMO cannot be corrected by reducing programmed sensitivity, ventricular lead revision is often required. The new Low Frequency Attenuation (LFA) filter in St. Jude Medical ICDs (St. Jude Medical, Sylmar, CA, USA) alters the sensing bandpass to reduce T-wave oversensing. This paper aims to present the LFA filter as a reversible cause of DMO. Unnecessary lead revision can be avoided by the simple programming solution of deactivating this LFA filter. ©2016 Wiley Periodicals, Inc.

Determinants and trajectory of phobic anxiety in patients living with an implantable cardioverter defibrillator.

PubMed

Cho, En-Young Nicole; von Känel, Roland; Marten-Mittag, Birgit; Ronel, Joram; Kolb, Christof; Baumert, Jens; Ladwig, Karl-Heinz

2012-05-01

The implantable cardioverter defibrillator (ICD) is the gold standard therapy to prevent life-threatening arrhythmias. Phobic anxiety predicts ventricular arrhythmia in coronary heart disease patients, but little is known about phobic anxiety in ICD patients. This study aimed to identify determinants and the course of phobic anxiety in ICD patients. 140 outpatients living with an ICD (mean age 56±14 years, 66% men). Phobic anxiety was assessed with the Symptom Checklist-90 Revised at a mean of 27±21 months (range 3-109) post-ICD placement (baseline) and after an average follow-up of 41±18 months (range 10-82). Multivariate linear regression models considered sociodemographic factors, clinical variables and psychological scales as potential determinants of phobic anxiety scores. ICD patients reported more than 10-fold higher levels of phobic anxiety than a previous representative population survey (2.6±3.4 vs 0.2±0.4). Greater age (p=0.003), previous shock experience (p=0.007), depressed mood (p<0.001) and hypochondriasis (p=0.005) were associated with higher phobic anxiety scores at baseline. Multimorbidity (p=0.030) and higher baseline phobic anxiety (p<0.001) determined greater phobic anxiety at follow-up. Younger age (p=0.029) and an elevated number of non-cardiac diseases (p=0.019) were both associated with an increase in phobic anxiety scores from baseline to follow-up. More patients had high phobic anxiety levels (score >4) at follow-up compared with baseline (31% vs 24%; p=0.048). Phobic anxiety was comparably high and persisted over time in ICD patients. Modifiable determinants of phobic anxiety were identified, which may inform tailored interventions to improve ICD patients' distress and perhaps also prognosis.

Disease Severity and Exercise Testing Reduce Subcutaneous Implantable Cardioverter-Defibrillator Left Sternal ECG Screening Success in Hypertrophic Cardiomyopathy.

PubMed

Srinivasan, Neil T; Patel, Kiran H; Qamar, Kashif; Taylor, Amy; Bacà, Marco; Providência, Rui; Tome-Esteban, Maria; Elliott, Perry M; Lambiase, Pier D

2017-04-01

The features of the hypertrophic cardiomyopathy (HCM) ECG make it a challenge for subcutaneous implantable cardioverter-defibrillator (S-ICD) screening. We aimed to investigate the causes of screening failure at rest and on exercise to inform optimal S-ICD ECG vector development. One hundred and thirty-one HCM patients (age, 50±16 years; 92 males and 39 females) with ≥1 HCM risk factor for sudden death underwent S-ICD ECG screening at rest and on exercise. Fifty patients (38%) were ineligible for S-ICD because of screening failure in every lead vector: 33 (66%) failed in the supine position, 12 (24%) failed in the standing position, and 5 (10%) failed on exercise. In patients who could exercise and passed screening at rest, 31 (44%) had 1 vector safety, 16 (23%) had 2 vector safety, and 24 (33%) had 3 vector safety. Increased R:T wave ratio in the S-ICD screening ECG (odds ratio, 4.0; confidence interval, 3.0-5.3; P <0.001) was associated with screening failure, while R/T ratio <3 in aVF (odds ratio, 0.3; confidence interval, 0.12-0.69; P =0.006) and increasing age (odds ratio, 0.97; confidence interval, 0.95-0.99; P =0.03) was associated with reduced screening failure. European Society of Cardiology risk score was higher in those failing screening (risk score 5.5% [interquartile range, 3.2-8.7] in failed versus 4.5% [interquartile range, 2.9-7.4] in passed; P =0.04). HCM patients have a significant incidence of screening failure, which is determined primarily by the increased R:T ratio on the screening ECG and lead aVF. High-risk patients have an increased screening failure rate. Optimization of sensing algorithms is required to ensure that the highest risk HCM patients can benefit from S-ICD implantation. © 2017 American Heart Association, Inc.

The healthcare utilization and cost of treating patients experiencing inappropriate implantable cardioverter defibrillator shocks: a propensity score study.

PubMed

Bhavnani, Sanjeev P; Giedrimiene, Dalia; Coleman, Craig I; Guertin, Danette; Azeem, Meena; Kluger, Jeffrey

2014-10-01

Inappropriate shocks (IASs) from implantable cardioverter defibrillators (ICDs) are associated with decreased quality of life, but whether they increase healthcare utilization and treatment costs is unknown. We sought to determine the impact of IASs on subsequent healthcare utilization and treatment costs. We conducted a case-control analysis of ICD patients at a single institution from 1997 to 2010 and who had ≥12 months of post-ICD implant follow-up. Cases included all patients experiencing an IAS during the first 12 months after implantation. Eligible control patients did not receive a shock of any kind during the 12 months after implantation. Propensity scores based on 36 covariates (area under curve = 0.78) were used to match cases to controls. We compared the rate (occurrences/person year [PY]) of healthcare utilization immediately following IAS to the end of the 12-month follow-up period to the rate in the no-shock group over 12 months of follow-up. We also compared 12-month postimplant treatment (outpatient clinic, emergency room, and hospitalization) costs in both groups. A total of 76 patients experiencing ≥1 IAS during the first 12 months after implant (contributing 48 PYs) were matched to 76 no-shock patients (contributing 76 PYs). Cardiovascular (CV)-related clinic visit and hospitalization rates were increased following an IAS compared to those not receiving a shock (4.0 vs 3.3 and 0.7 vs 0.5, respectively, P = 0.02 for both). CV-related emergency room visitation (0.15 vs 0.08) rates were also numerically higher following an IAS, but did not reach statistical significance (P = 0.26). Patients experiencing an IAS accrued greater treatment costs during the 12 months postimplant compared to no-shock patients ($13,973 ± $46,345 vs $6,790 ± $19,091, P = 0.001). Recipients of IAS utilize the healthcare system more frequently following an IAS than patients not experiencing a shock. This increased utilization results in higher costs of treating IAS

Development and evaluation of the EOL-ICDQ as a measure of experiences, attitudes and knowledge in end-of-life in patients living with an implantable cardioverter defibrillator.

PubMed

Thylén, Ingela; Wenemark, Marika; Fluur, Christina; Strömberg, Anna; Bolse, Kärstin; Årestedt, Kristofer

2014-04-01

Due to extended indications and resynchronization therapy, many implantable cardioverter defibrillator (ICD) recipients will experience progressive co-morbid conditions and will be more likely to die of causes other than cardiac death. It is therefore important to elucidate the ICD patients' preferences when nearing end-of-life. Instead of avoiding the subject of end-of-life, a validated questionnaire may be helpful to explore patients' experiences and attitudes about end-of-life concerns and to assess knowledge of the function of the ICD in end-of-life. Validated instruments assessing patients' perspective concerning end-of-life issues are scarce. The purpose of this study was to develop and evaluate respondent satisfaction and measurement properties of the 'Experiences, Attitudes and Knowledge of End-of-Life Issues in Implantable Cardioverter Defibrillator Patients' Questionnaire' (EOL-ICDQ). The instrument was tested for validity, respondent satisfaction, and for homogeneity and stability in the Swedish language. An English version of the EOL-ICDQ was validated, but has not yet been pilot tested. The final instrument contained three domains, which were clustered into 39 items measuring: experiences (10 items), attitudes (18 items), and knowledge (11 items) of end-of-life concerns in ICD patients. In addition, the questionnaire also contained items on socio-demographic background (six items) and ICD-specific background (eight items). The validity and reliability properties were considered sufficient. The EOL-ICDQ has the potential to be used in clinical practice and future research. Further studies are needed using this instrument in an Anglo-Saxon context with a sample of English-speaking ICD recipients.

PS3-11: Beyond General Equivalency Mappings (GEMs): Understanding the Implications of ICD 10 in Research

PubMed Central

Riordan, Rick

2013-01-01

Background/Aims With the implementation of ICD 10 CM and ICD 10 PCS less than two years away, there are still unanswered questions as to how research teams will effectively translate or use ICD 10 codes in research. Approximately 84% of the ICD 10 codes have only approximate matches with 10% having multiple matches and only 5% have exact one-to-one matches between ICD 9 and ICD 10. With the number of codes increasing five-fold, this offers additional opportunities and risks when pulling data. Methods Besides looking at the General Equivalency Mappings and other tools that are used to translate ICD 9 codes to ICD 10 codes, we will examine some common research areas where only approximate matches between ICD 9 and ICD 10 exist. We will also discuss how the finer level of detail that ICD 10 gives allows research teams to pinpoint exactly what type of asthma, Crohn’s disease, and diabetic retinopathy they wish to study without including some of the other cases that do not meet their research criteria. Results There are significant ambiguities and irregularity in several common areas such as diabetes, mental health, asthma, and gastroenterology due to approximate, multiple, or combination matches. Even in the case of exact matches such as an old myocardial infarction where there is an exact match, the definition of when a myocardial infarction becomes “old” is different. Conclusions ICD 10 offers a finer level of detail and a higher level of specificity, thereby allowing research teams to be more targeted when pulling data. On the other hand, research teams need to exercise caution when using GEMs and other tools to translate ICD 9 codes into ICD 10 codes and vice versa, especially if they are looking at data that overlaps the implementation date of October 1, 2014.

Diagnostic Value of MRI in Patients With Implanted Pacemakers and Implantable Cardioverter-Defibrillators Across a Cross Population: Does the Benefit Justify the Risk? A Proof of Concept Study.

PubMed

Samar, Huma; Yamrozik, June A; Williams, Ronald B; Doyle, Mark; Shah, Moneal; Bonnet, Christopher A; Biederman, Robert W W

2017-09-01

The objective of this study was to assess the diagnostic usefulness of thoracic and nonthoracic magnetic resonance imaging (MRI) imaging in patients with implantable cardiac devices (permanent pacemaker or implantable cardioverter-defibrillators [ICDs]) to determine if there was a substantial benefit to patients with regard to diagnosis and/or management. MRI is infrequently performed on patients with conventional pacemakers or ICDs. Multiple studies have documented the safety of MRI scans in patients with implanted devices, yet the diagnostic value of this approach has not been established. Evaluation data were acquired in 136 patients with implanted cardiac devices who underwent MRIs during a 10-year period at a single institution. Specific criteria were followed for all patients to objectively define if the diagnosis by MRI enhanced patient care; 4 questions were answered after scan interpretation by both MRI technologists and MRI physicians who performed the scan. 1) Did the primary diagnosis change? 2) Did the MRI provide additional information to the existing diagnosis? 3) Was the pre-MRI (tentative) diagnosis confirmed? 4) Did patient management change? If "Yes" was answered to any of the preceding questions, the MRI scan was considered to be of value to patient diagnosis and/or therapy. In 97% (n = 132) of patients, MR added value to patient diagnosis and management. In 49% (n = 67) of patients, MRI added additional valuable information to the primary diagnosis, and in 30% (n = 41) of patients, MRI changed the principle diagnosis and subsequent management of the patient. No safety issues were encountered, and no adverse effects of undergoing the MRI scan were noted in any patient. MRI in patients with implanted pacemakers and defibrillators added value to patient diagnosis and management, which justified the risk of the procedure. Published by Elsevier Inc.