Three-year outcome of a nonthoracotomy approach to cardioverter-defibrillator implantation in 189 consecutive patients.

PubMed

Brooks, R; Garan, H; Torchiana, D; Vlahakes, G J; Dziuban, S; Newell, J; McGovern, B A; Ruskin, J N

1994-11-15

To date, no long-term clinical data have been published in patients undergoing a nonthoracotomy approach to cardioverter-defibrillator system implantation. In the present report, 189 consecutive patients prospectively underwent a standardized approach to cardioverter-defibrillator system implantation in which the nonthoracotomy configurations were tested first. If satisfactory defibrillation thresholds were not obtained, thoracotomy was performed during the same intraoperative session. A nonthoracotomy system was successfully implanted in 149 of 189 patients (79%), with a higher success rate (90%) observed in patients who had more recent implantations. The overall rate of complications associated with these systems was low (11%). Over a mean follow-up of 12.5 +/- 9.3 months, 17 patients (9%) died. Three-year total, cardiac, and sudden death-free actuarial survival for all patients was 83 +/- 11%, 88 +/- 7%, and 94 +/- 2%, respectively. Three-year sudden death-free actuarial survival was higher in the nonthoracotomy than in the thoracotomy patients (97 +/- 2% vs 87 +/- 6%, p = 0.047), although total survival was similar (77 +/- 11% vs 83 +/- 7%, p = 0.77). These data suggest that a majority of patients (> 80%) requiring a cardioverter-defibrillator system can undergo implantation using a nonthoracotomy approach. Patients receiving nonthoracotomy systems have 3-year outcomes comparable to those implanted via thoracotomy. If these results are maintained, a nonthoracotomy approach will supplant thoracotomy-implanted systems as the preferred method because of the simpler implant procedure and lower overall cost involved.

Emotions and health: findings from a randomized clinical trial on psychoeducational nursing to patients with implantable cardioverter defibrillator.

PubMed

Kikkenborg Berg, Selina; Støier, Louise; Moons, Philip; Zwisler, Ann-Dorthe; Winkel, Per; Ulrich Pedersen, Preben

2015-01-01

Serious illness will inevitably lead to a fundamental emotional reaction. Traditionally, in interventional treatment or rehabilitation trials, the psychological status of patients with implantable cardioverter defibrillators has been evaluated with anxiety and depression as outcome measures. In caring for these patients, the aim of nursing is to help patients manage life with complex heart disease. The early detection and management of negative emotional response might prevent the development of pathological conditions such as depression. The aims of this study were to (a) describe the trajectory of primary emotions over time in patients with implantable cardioverter defibrillators and (b) examine the potential effects of psychoeducational nursing on primary emotions. During the inclusion period (October 2007 to November 2009), 196 patients with implantable cardioverter defibrillator were randomized (1:1) to rehabilitation versus usual care. Rehabilitation consisted of a psychoeducational nursing component and an exercise training component. This article concerns phase 1, psychoeducational nursing, guided by a theory of nursing, Rosemary Rizzo Parses Human Becoming Practice Methodologies. The outcome measure is the Emotions and Health Scale. The scale consists of 8 primary emotions: joy, agreeableness, surprise, fear, sadness, disgust, anger, and anticipation. Mean (SD) age was 58 (13) years, and 79% of the participants were men. Significant improvements were found in primary emotional responses over time (P < .05) when combining groups. However, no difference in emotional intensity was found between the groups after 3 months of psychoeducational nursing intervention (P > .05). Primary emotions are affected after implantable cardioverter defibrillator implantation. Improvements over time were found. However, it was not possible to detect any effect of a short-term psychoeducational nursing intervention. Evaluating the primary emotions might be a good way for nurses

Multicenter Automatic Defibrillator Implantation Trial-Subcutaneous Implantable Cardioverter Defibrillator (MADIT S-ICD): Design and clinical protocol.

PubMed

Kutyifa, Valentina; Beck, Christopher; Brown, Mary W; Cannom, David; Daubert, James; Estes, Mark; Greenberg, Henry; Goldenberg, Ilan; Hammes, Stephen; Huang, David; Klein, Helmut; Knops, Reinoud; Kosiborod, Mikhail; Poole, Jeanne; Schuger, Claudio; Singh, Jagmeet P; Solomon, Scott; Wilber, David; Zareba, Wojciech; Moss, Arthur J

2017-07-01

Patients with diabetes mellitus, prior myocardial infarction, older age, and a relatively preserved left ventricular ejection fraction remain at risk for sudden cardiac death that is potentially amenable by the subcutaneous implantable cardioverter defibrillator with a good risk-benefit profile. The launched MADIT S-ICD study is designed to test the hypothesis that post-myocardial infarction diabetes patients with relatively preserved ejection fraction of 36%-50% will have a survival benefit from a subcutaneous implantable cardioverter defibrillator. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

Factors associated with health-related quality of life among patients with implantable cardioverter defibrillator: identification of foci for nursing intervention.

PubMed

Wong, Florence Mei Fung; Sit, Janet Wing Hung; Wong, Eliza Mi Ling; Choi, Kai Chow

2014-12-01

To explore factors associated with health-related quality of life of patients with implantable cardioverter defibrillators. Substantial evidence indicates that implantable cardioverter defibrillator is proven to increase survival rate by terminating life-threatening arrhythmia. However, this device can negatively affect health-related quality of life. Little is known about factors associated with health-related quality of life of patients with implantable cardioverter defibrillators, particularly in Asian population. A transversal descriptive design was used. Data were collected from a convenience sample of 139 adult patients with implantable cardioverter defibrillators from 4 January-30 April 2012 using the structured questionnaires administered by the researcher and medical record reviews. The Short Form-36 Health Survey version 2 was used to measure health-related quality of life. A total of 139 Chinese patients, including 107 (77·0%) males with a mean age of 63·0 (14·6) years, were selected. The physical component summary was relatively lower, whereas the mental component summary was relatively higher than that of the general Hong Kong Chinese population. Multivariable regression analysis revealed gender, self-care dependence, educational level, atrial fibrillation, diabetes mellitus, anxiety and depression significantly associated with physical or mental quality of life. Depression was a common factor affecting physical and mental quality of life. Self-care dependence, atrial fibrillation, diabetes mellitus, depression and anxiety could be improved. Our findings expand existing knowledge on identifying at-risk patients for having lower quality of life, thus allowing development of appropriate interventions targeting risk factors for improving health-related quality of life of patients with implantable cardioverter defibrillator. © 2014 John Wiley & Sons Ltd.

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.

Cardioverter-defibrillator implantation in myeloma-associated cardiac amyloidosis

PubMed Central

Campanile, Alfonso; Sozzi, Fabiola B; Canetta, Ciro; Danzi, Gian Battista

2013-01-01

A 62-year-old woman with multiple myeloma and light-chain amyloidosis with significant heart involvement developed an in-hospital cardiac arrest. After cardiopulmonary resuscitation, a stable sinus rhythm without any cerebral damage was restored, and the patient was admitted to the coronary care unit. A cardioverter-defibrillator was implanted, and it successfully intervened in two sustained ventricular tachycardia episodes and one ventricular fibrillation episode, which were recorded during hospitalization. After achieving discrete cardiac compensation, the patient was transferred to the emergency medicine department where she underwent chemotherapy for multiple myeloma. The patient died 40 days after admission from refractory heart failure. In the literature, there are studies that describe the use of cardioverter-defibrillator implantation in cardiac amyloidosis; however, at present, there is no evidence of a beneficial effect on survival with the use of this intervention. A high index of suspicion for amyloid heart disease and early diagnosis are critical to improving outcomes. PMID:24294034

Cardioverter-defibrillator implantation in myeloma-associated cardiac amyloidosis.

PubMed

Campanile, Alfonso; Sozzi, Fabiola B; Canetta, Ciro; Danzi, Gian Battista

2013-01-01

A 62-year-old woman with multiple myeloma and light-chain amyloidosis with significant heart involvement developed an in-hospital cardiac arrest. After cardiopulmonary resuscitation, a stable sinus rhythm without any cerebral damage was restored, and the patient was admitted to the coronary care unit. A cardioverter-defibrillator was implanted, and it successfully intervened in two sustained ventricular tachycardia episodes and one ventricular fibrillation episode, which were recorded during hospitalization. After achieving discrete cardiac compensation, the patient was transferred to the emergency medicine department where she underwent chemotherapy for multiple myeloma. The patient died 40 days after admission from refractory heart failure. In the literature, there are studies that describe the use of cardioverter-defibrillator implantation in cardiac amyloidosis; however, at present, there is no evidence of a beneficial effect on survival with the use of this intervention. A high index of suspicion for amyloid heart disease and early diagnosis are critical to improving outcomes.

[Primary prevention of sudden cardiac death through a wearable cardioverter-defibrillator].

PubMed

Gabrielli, Domenico; Benvenuto, Manuela; Baroni, Matteo; Oliva, Fabrizio; Capucci, Alessandro

2015-01-01

Nowadays, the implantable cardioverter-defibrillator is the gold standard for the prevention of sudden cardiac death due to tachyarrhythmias. However, its use is not free from short and long-term risks. In the last years, the wearable cardioverter-defibrillator (WCD) has become a widespread option for patients who need a safe and reversible protection against ventricular tachyarrhythmias. Notwithstanding this, its everyday application is restricted by several limitations, including the risk of inappropriate shocks, the device size and the need for strict compliance of both patients and caregivers. In this review, we report the most relevant literature data on WCD usage along with the main fields of applications and future perspectives.

Association between patient activity and long-term cardiac death in patients with implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators.

PubMed

Zhao, Shuang; Chen, Keping; Su, Yangang; Hua, Wei; Chen, Silin; Liang, Zhaoguang; Xu, Wei; Dai, Yan; Liu, Zhimin; Fan, Xiaohan; Hou, Cuihong; Zhang, Shu

2017-05-01

Background Patient activity (PA) has been demonstrated to predict all-cause mortality. However, the association between PA and cardiac death is unclear. Aims The aims of this study were to determine whether PA can predict cardiac death and what is the cut-off of PA to discriminate cardiac death, as well as the mechanism underlying the relationship between PA and survival in patients with home monitoring. Methods This study retrospectively analysed clinical and implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator device data in 845 patients. Data regarding PA and PP variability during the first 30-60 days of home monitoring were collected, and mean values were calculated. The primary endpoint was cardiac death, and the secondary endpoint was all-cause mortality. Results The mean PA percentage was 11 ± 5.8%. Based on receiver operating characteristic curve analysis, we determined that a PA cut-off value of 7.84% (113 min) can predict cardiac death. During a mean follow-up period of 31.1 ± 12.9 months (ranging from three to 60 months), PA ≤ 7.84% was associated with increased risks of cardiac death in an unadjusted analysis; after adjusting in a multivariate Cox model, the relationship remained significant between PA≤7.84% and cardiac death (hazard ratio = 3.644, 95% confidence interval = 2.424-5.477, p < 0.001). Moreover, a significant correlation was observed between PA and PP variability ( r = 0.601, p < 0.001). Conclusions A baseline PA ≤ 7.84% was associated with a higher risk of cardiac death in patients who have survived more than three months after implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator implantation. PA had a sizable effect on heart rate variability, reflecting autonomic function.

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.

Living with life-saving technology - coping strategies in implantable cardioverter defibrillators recipients.

PubMed

Flemme, Inger; Johansson, Ingela; Strömberg, Anna

2012-02-01

To describe coping strategies and coping effectiveness in recipients with an implantable cardioverter defibrillator and to explore factors influencing coping. Implantable cardioverter defibrillators are documented as saving lives and are used to treat ventricular tachycardia and ventricular fibrillation. Despite the implantable cardioverter defibrillator not evidently interfering with everyday life, there is conflicting evidence regarding the psychosocial impact of an implantable cardioverter defibrillator implantation such as anxiety, depression, perceived control and quality of life and how these concerns may relate to coping. Cross-sectional multicentre design. Individuals (n = 147, mean age 63 years, 121 men) who had lived with an implantable cardioverter defibrillator between 6-24 months completed the Jalowiec Coping Scale-60, Hospital Anxiety and Depression Scale, Control Attitude Scale and Quality of Life Index-Cardiac version. Implantable cardioverter defibrillators recipients seldom used coping strategies, and the coping strategies used were perceived as fairly helpful. Optimism was found to be the most frequently used (1·8 SD 0·68) and most effective (2·1 SD 0·48) coping strategy, and recipients perceived moderate control in life. Anxiety (β = 3·5, p ≤ 0·001) and gender (β = 12·3, p = 0·046) accounted for 26% of the variance in the total use of coping strategies, suggesting that the more symptoms of anxiety and being women the greater use of coping strategies. Most recipients with an implantable cardioverter defibrillator did not appraise daily concerns as stressors in need of coping and seem to have made a successful transition in getting on with their lives 6-24 months after implantation. Relevance to clinical practice.  Nurses working with recipients with an implantable cardioverter defibrillator should have a supportive communication so that positive outcomes such as decreased anxiety and increased perceived control and quality of life

Clinical impact of defibrillation testing at the time of implantable cardioverter-defibrillator insertion.

PubMed

Hadid, Claudio; Atienza, Felipe; Strasberg, Boris; Arenal, Ángel; Codner, Pablo; González-Torrecilla, Esteban; Datino, Tomás; Percal, Tamara; Almendral, Jesús; Ortiz, Mercedes; Martins, Raphael; Martinez-Alzamora, Nieves; Fernandez Aviles, Francisco

2015-01-01

Ventricular fibrillation is routinely induced during implantable cardioverter-defibrillator insertion to assess defibrillator performance, but this strategy is experiencing a progressive decline. We aimed to assess the efficacy of defibrillator therapies and long-term outcome in a cohort of patients that underwent defibrillator implantation with and without defibrillation testing. Retrospective observational series of consecutive patients undergoing initial defibrillator insertion or generator replacement. We registered spontaneous ventricular arrhythmias incidence and therapy efficacy, and mortality. A total of 545 patients underwent defibrillator implantation (111 with and 434 without defibrillation testing). After 19 (range 9-31) months of follow-up, the death rate per observation year (4% vs. 4%; p = 0.91) and the rate of patients with defibrillator-treated ventricular arrhythmic events per observation year (with test: 10% vs. without test: 12%; p = 0.46) were similar. The generalized estimating equations-adjusted first shock probability of success in patients with test (95%; CI 88-100%) vs. without test (98%; CI 96-100%; p = 0.42) and the proportion of successful antitachycardia therapies (with test: 87% vs. without test: 80%; p = 0.35) were similar between groups. There was no difference in the annualized rate of failed first shock per patient and per shocked patient between groups (5% vs. 4%; p = 0.94). In this observational study, that included an unselected population of patients with a defibrillator, no difference was found in overall mortality, first shock efficacy and rate of failed shocks regardless of whether defibrillation testing was performed or not.

[LifeVest - a novel treatment option prior to implantable cardioverter defibrillator].

PubMed

Mustafić, Hazrije; Karimzadeh, Soran; Park, Chan-Il

2017-03-01

Implantable cardioverter defibrillation has taken a predominant place in secondary and primary preventions of sudden rhythmic cardiac death in high-risk patients. However, in certain clinical situations, the implantation of definitive system should be postponed. The LifeVest, a portable external cardiac defibrillator system, has emerged as a novel therapeutic option before a final decision.

Driving safety among patients with automatic implantable cardioverter defibrillators.

PubMed

Finch, N J; Leman, R B; Kratz, J M; Gillette, P C

1993-10-06

To determine the driving behavior of patients following the placement of automatic implantable cardioverter defibrillators (AICDs). Forty patients with AICDs (33 men, seven women; mean age, 62.7 years) responded to a questionnaire designed to ascertain driving behavior after hospital discharge. Despite medical advice never to drive again, 28 patients (70%) resumed driving, with the majority doing so by 8 months after AICD implantation. Of these, 11 (40%) identified themselves as the primary driver in their household. Fourteen (50%) drove daily. Two (7%) were driving and continued to drive during discharge of their AICDs. Twenty-five (91%) reported that they felt comfortable and safe while driving. A majority of patients with AICDs continue to drive after a proscription of this activity by health care workers.

[The wearable cardioverter/defibrillator : Temporary protection from sudden cardiac death].

PubMed

Duncker, D; Bauersachs, J; Veltmann, C

2016-09-01

In the majority of cases sudden cardiac death (SCD) is caused by ventricular tachyarrhythmia. Implantable cardioverter-defibrillators (ICD) represent an evidence-based and established method for prevention of SCD. For patients who do not fulfill the criteria for guideline-conform implantation of an ICD but still have an increased, e.g. transient risk for SCD, a wearable cardioverter-defibrillator (WCD) vest was developed to temporarily prevent SCD. Numerous studies have shown the safety and efficacy of the WCD, although there is still a gap in evidence concerning a reduction in overall mortality and improvement in prognosis. This article gives an overview on the currently available literature on WCD, the indications, potential risks and complications.

Clinical efficacy of the wearable cardioverter-defibrillator in acutely terminating episodes of ventricular fibrillation.

PubMed

Auricchio, A; Klein, H; Geller, C J; Reek, S; Heilman, M S; Szymkiewicz, S J

1998-05-15

The findings of our initial study demonstrate for the first time the ability to terminate induced VT/VF reliably (100% of all episodes) by a single, monophasic 230-J shock delivered by the Wearable Cardioverter-Defibrillator (WCD). Although limited by sample size, our data suggest the WCD could be used as a feasible bridge to definitive implantation of an implantable cardioverter-defibrillator in patients in whom risk stratification for sudden death is not completed.

Evaluation of outpatients experiencing implantable cardioverter defibrillator shocks associated with minimal symptoms.

PubMed

Hamer, M E; Clair, W K; Wilkinson, W E; Greenfield, R A; Pritchett, E L; Page, R L

1994-05-01

Patients receiving minimally symptomatic shocks from their implantable cardioverter defibrillators were studied prospectively using transtelephonic ECG loop monitoring. The time course to the first subsequent shock was evaluated. Twenty-nine consecutive patients who received a shock preceded by mild palpitations or no symptoms were given a transtelephonic ECG loop monitor and instructed to activate the monitor if a subsequent shock occurred. Kaplan-Meier analysis was used to quantitate the time to first shock during the study period. The point estimate +/- standard error of patients receiving a shock during the study period was 31% +/- 9% at 30 days, 41% +/- 9% at 60 days, and 60% +/- 9% at 120 days. The ECG was successfully transmitted in 7 of 13 patients who had shocks in the 60-day monitoring period, and demonstrated inappropriate shocks in 6 of 7. Determination of the cause of shock led to a change in subsequent management in all 7 patients. We conclude that the incidence of inappropriate shocks may be higher than estimated previously in patients with minimal symptoms prior to the shock. There are thousands of patients with implantable cardioverter defibrillators that have no storage function for treated tachycardias; transtelephonic ECG loop monitoring can determine the cause of implantable cardioverter defibrillator discharge in these patients, and the diagnosis is invaluable in their management.

Position of Subcutaneous Implantable Cardioverter-Defibrillators and Possible Interference on Myocardial Perfusion Imaging.

PubMed

Kahaly, Omar Ray; Shafiei, Fereidoon; Hardebeck, Charles; Houmsse, Mahmoud

2017-06-01

Implanted cardioverter-defibrillators can prevent sudden cardiac death in at-risk patients. In comparison with conventional transvenous systems, entirely subcutaneous implantable cardioverter-defibrillators have produced similar reductions in the rate of sudden cardiac death but with fewer sequelae. An infrequently reported drawback of subcutaneous devices, however, is the potential for generating attenuation artifact during nuclear myocardial perfusion imaging. We had concerns about potential attenuation artifact in a 65-year-old man with coronary artery disease but found that having positioned the pulse generator in the midaxillary zone avoided problems.

[The subcutaneous cardioverter-defibrillator: When less is more].

PubMed

Kuschyk, J; Rudic, B; Akin, I; Borggrefe, M; Röger, S

2015-06-01

In the last few decades, defibrillator therapy has revolutionized treatment of patients at risk for sudden cardiac death. Multiple clinical trials have shown the benefit of implantable cardioverter-defibrillators (ICD) for primary and secondary prevention of sudden cardiac death. Being an entirely subcutaneous system, the S-ICD® avoids important periprocedural and long-term complications associated with transvenous implantable cardioverter-defibrillator (TV-ICD) systems as well as the need for fluoroscopy during implant surgery. In patients with challenging anatomic conditions or after infection, the S-ICD® might be reasonable. In multicenter studies and registries efficacy and safety of the S-ICD® was equal or better to transvenous implantable defibrillators. The cardiac rhythm is detected by the use of 1 of the 3 potential vectors. The S-ICD® automatically selects the most suitable vector for rhythm detection. If ventricular tachyarrhythmia is detected, the device is able to deliver up to five shocks of 80 J, while postshock pacing is available at 50 bpm for 30 s. The implantation technique is different from that of conventional ICDs, but easily learnable by experienced cardiologists. Initially observed hurdles (e.g., inappropriate shocks or infections) have been overcome by standardized implantation techniques, operator learning curves, and modification of algorithms. The S-ICD® predominately might be suitable in all patients with ICD indication except patients with pacing or cardiac resynchronization therapy (CRT) indication, ventricular tachycardia < 170 bpm, negative screening, or in the occasional patient whose arrhythmia might be suppressed by overdrive pacing. The system received CE certification in 2009 and was approved by the FDA in 2012. Currently, in Germany the S-ICD® has been integrated into the DRG system and can be reimbursed as a single chamber ICD.

Wearable Cardioverter-Defibrillators following Cardiac Surgery-A Single-Center Experience.

PubMed

Heimeshoff, Jan; Merz, Constanze; Ricklefs, Marcel; Kirchhoff, Felix; Haverich, Axel; Bara, Christoph; Kühn, Christian

2018-06-20

 A wearable cardioverter-defibrillator (WCD) can terminate ventricular fibrillation and ventricular tachycardias via electrical shock and thus give transient protection from sudden cardiac death. We investigated its role after cardiac surgery.  We retrospectively analyzed all patients who were discharged with a WCD from cardiac surgery department. The WCD was prescribed for patients with a left ventricular ejection fraction (LVEF) of ≤35% or an explanted implantable cardioverter-defibrillator (ICD).  A total of 100 patients were included in this study, the majority ( n  = 59) had received coronary artery bypass graft surgery. The median wearing time of a WCD patient was 23.5 hours per day. LVEF was 28.9 ± 8% after surgery and improved in the follow-up to 36.7 ± 11% ( p  < 0.001). Three patients were successfully defibrillated. Ten patients experienced ventricular tachycardias. No inappropriate shocks were given. An ICD was implanted in 25 patients after the WCD wearing period.  Ventricular arrhythmias occurred in 13% of the investigated patients. LVEF improved significantly after 3 months, and thus a permanent ICD implantation was avoided in several cases. Sternotomy did not impair wearing time of the WCD. A WCD can effectively protect patients against ventricular tachyarrhythmias after cardiac surgery. Georg Thieme Verlag KG Stuttgart · New York.

No Electromagnetic Interference Occurred in a Patient with a HeartMate II Left Ventricular Assist System and a Subcutaneous Implantable Cardioverter-Defibrillator.

PubMed

Raman, Ajay Sundara; Shabari, Farshad Raissi; Kar, Biswajit; Loyalka, Pranav; Hariharan, Ramesh

2016-04-01

The use of subcutaneous implantable cardioverter-defibrillators is a novel option for preventing arrhythmia-mediated cardiac death in patients who are at risk of endovascular-device infection or in whom venous access is difficult. However, the potential for electromagnetic interference between subcutaneous defibrillators and left ventricular assist devices is largely unknown. We report the case of a 24-year-old man in whom we observed no electromagnetic interference between a subcutaneous implanted cardioverter-defibrillator and a HeartMate II Left Ventricular Assist System, at 3 different pump speeds. To our knowledge, this is the first report of such findings in this circumstance.

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.

No Electromagnetic Interference Occurred in a Patient with a HeartMate II Left Ventricular Assist System and a Subcutaneous Implantable Cardioverter-Defibrillator

PubMed Central

Raman, Ajay Sundara; Kar, Biswajit; Loyalka, Pranav; Hariharan, Ramesh

2016-01-01

The use of subcutaneous implantable cardioverter-defibrillators is a novel option for preventing arrhythmia-mediated cardiac death in patients who are at risk of endovascular-device infection or in whom venous access is difficult. However, the potential for electromagnetic interference between subcutaneous defibrillators and left ventricular assist devices is largely unknown. We report the case of a 24-year-old man in whom we observed no electromagnetic interference between a subcutaneous implanted cardioverter-defibrillator and a HeartMate II Left Ventricular Assist System, at 3 different pump speeds. To our knowledge, this is the first report of such findings in this circumstance. PMID:27127441

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.

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,…

Spouses' reflections on implantable cardioverter defibrillator treatment with focus on the future and the end-of-life: a qualitative content analysis.

PubMed

Fluur, Christina; Bolse, Kärstin; Strömberg, Anna; Thylén, Ingela

2014-08-01

To explore future reflections of spouses living with an implantable cardioverter defibrillator recipient with focus on the end-of-life phase in an anticipated palliative phase. A history of or risk for life-threatening arrhythmias may require an implantable cardioverter defibrillator. Despite the life-saving capacity of the device, eventually life will come to an end. As discussion about preferences of shock therapy at end-of-life phase seldom takes place in advance, the implantable cardioverter defibrillator recipients may face defibrillating shocks in the final weeks of their lives, adding to stress and anxiety in patients and their families. Qualitative study with in-depth interviews analysed with a content analysis. Interviews were performed with 18 spouses of medically stable implantable cardioverter defibrillator recipients during 2011-2012. The spouses described how they dealt with changes in life and an uncertain future following the implantable cardioverter defibrillator implantation. Six subcategories conceptualized the spouses' concerns: Aspiring for involvement; Managing an altered relationship; Being attentive to warning signs; Worries for deterioration in the partner's health; Waiting for the defibrillating shock; and Death is veiled in silence. Despite the partner's serious state of health; terminal illness or death and the role of the device was seldom discussed with healthcare professionals or the implantable cardioverter defibrillator recipient. Open and honest communication was requested as important to support coping with an unpredictable life situation and to reduce worries and uncertainty about the future and end-of-life. © 2013 John Wiley & Sons Ltd.

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

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.

Psychometric properties of HeartQoL, a core heart disease-specific health-related quality of life questionnaire, in Danish implantable cardioverter defibrillator recipients.

PubMed

Zangger, Graziella; Zwisler, Ann-Dorthe; Kikkenborg Berg, Selina; Kristensen, Marie S; Grønset, Charlotte N; Uddin, Jamal; Pedersen, Susanne S; Oldridge, Neil B; Thygesen, Lau C

2018-01-01

Background Patient-reported health-related quality of life is increasingly used as an outcome measure in clinical trials and as a performance measure to evaluate quality of care. The objective of this study was to assess the psychometric properties of the Danish HeartQoL questionnaire, a core heart disease-specific health-related quality of life questionnaire, in implantable cardioverter defibrillator recipients. Design This study involved cross-sectional and test-retest study designs. Method Implantable cardioverter defibrillator recipients in the cross-sectional study completed the HeartQoL, the Short-Form 36 Health Survey, and the Hospital Anxiety and Depression Scale. The HeartQoL structure, construct-related validity (convergent and discriminative) and reliability (internal consistency) were assessed. HeartQoL reproducibility (test-retest) was assessed in an independent sample of implantable cardioverter defibrillator recipients. Results Mokken scale analysis supported the bi-dimensional structure of HeartQoL among 358 implantable cardioverter defibrillator recipients. Convergent ( r > 0.72) and discriminative validity were confirmed. The HeartQoL scales demonstrated satisfactory internal consistency (Cronbach's alpha > 0.90). Test-retest reliability (two weeks interval) was assessed in 89 implantable cardioverter defibrillator recipients and found to be acceptable for each scale (intra-class correlation > 0.90). Conclusion The Danish HeartQoL questionnaire demonstrated satisfactory key psychometric attributes of validity and reliability in this implantable cardioverter defibrillator population. This study adds support for the HeartQoL as a core heart-specific health-related quality of life questionnaire in a broad group of patients with heart disease including implantable cardioverter defibrillator recipients.

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

PubMed

Basta, Lofty L

2003-01-01

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

Protein biomarkers identify patients unlikely to benefit from primary prevention implantable cardioverter defibrillators: findings from the Prospective Observational Study of Implantable Cardioverter Defibrillators (PROSE-ICD).

PubMed

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

2014-12-01

Primary prevention implantable cardioverter defibrillators (ICDs) reduce all-cause mortality, but the benefits are heterogeneous. Current risk stratification based on left ventricular ejection fraction has limited discrimination power. We hypothesize that biomarkers for inflammation, neurohumoral activation, and cardiac injury can predict appropriate shocks and all-cause mortality in patients with primary prevention ICDs. The Prospective Observational Study of Implantable Cardioverter Defibrillators (PROSe-ICD) enrolled 1189 patients with systolic heart failure who underwent ICD implantation for primary prevention of sudden cardiac death. The primary end point was an ICD shock for adjudicated ventricular tachyarrhythmia. The secondary end point was all-cause mortality. After a median follow-up of 4.0 years, 137 subjects experienced an appropriate ICD shock and 343 participants died (incidence rates of 3.2 and 5.8 per 100 person-years, respectively). In multivariable-adjusted models, higher interleukin-6 levels increased the risk of appropriate ICD shocks. In contrast, C-reactive protein, interleukin-6, tumor necrosis factor-α receptor II, pro-brain natriuretic peptide (pro-BNP), and cardiac troponin T showed significant linear trends for increased risk of all-cause mortality across quartiles. A score combining these 5 biomarkers identified patients who were much more likely to die than to receive an appropriate shock from the ICD. An increase in serum biomarkers of inflammation, neurohumoral activation, and myocardial injury increased the risk for death but poorly predicted the likelihood of an ICD shock. These findings highlight the potential importance of serum-based biomarkers in identifying patients who are unlikely to benefit from primary prevention ICDs. clinicaltrials.gov; Unique Identifier: NCT00733590. © 2014 American Heart Association, Inc.

Implantable cardioverter-defibrillator implantation for primary and secondary prevention: indications and outcomes.

PubMed

Pick, Justin M; Batra, Anjan S

2017-01-01

Implantable cardioverter-defibrillators effectively reduce the rate of sudden cardiac death in children. Significant efforts have been made to better characterise the indications for their placement, and over the past two decades there has been a shift in their use from secondary to primary prevention. Primary prevention includes placement in patients thought to be at high risk of sudden cardiac death before the patient experiences any event. Secondary prevention includes placement after a high-risk event including sustained ventricular tachycardia or resuscitated cardiac arrest. Although liberal device implantation may be appealing even in patients having marginal indications, studies have shown high rates of adverse effects including inappropriate device discharges and the need for re-intervention because of hardware malfunction. The indications for placement of an implantable cardioverter-defibrillator, whether for primary or secondary prevention of sudden cardiac death, vary based on cardiac pathology. This review will assist the provider in understanding the risks and benefits of device implantation in order to enhance the shared decision-making capacity of patients, families, and providers.

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.

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.

Implant and clinical characteristics for pediatric and congenital heart patients in the national cardiovascular data registry implantable cardioverter defibrillator registry.

PubMed

Jordan, Christopher P; Freedenberg, Vicki; Wang, Yongfei; Curtis, Jeptha P; Gleva, Marye J; Berul, Charles I

2014-12-01

In 2010, the National Cardiovascular Data Registry enhanced pediatric, nonatherosclerotic structural heart disease and congenital heart disease (CHD) data collection. This report characterizes CHD and pediatric patients undergoing implantable cardioverter defibrillator implantation. In this article, we report implantable cardioverter defibrillator procedures (April 2010 to December 2012) in the registry for 2 cohorts: (1) all patients with CHD (atrial septal defect, ventricular septal defect, tetralogy of Fallot, Ebstein anomaly, transposition of the great vessels, and common ventricle) and (2) patients <21 years. We evaluated indications and characteristics to include transvenous and nontransvenous lead implants, CHD type, and New York Heart Association class. There were 3139 CHD procedures, 1601 for patients <21 years and 126 for CHD <21 years. Implantable cardioverter defibrillator indications for patients with CHD were primary prevention in 1943 (61.9%) and secondary prevention in 1107 (35.2%). Pediatric patients had 935 (58.4%) primary prevention and 588 (36.7%) secondary prevention devices. Primary prevention had higher New York Heart Association class. Nontransvenous age (35.9 ± 23.2 versus 40.1 ± 24.6 years; P=0.05) and nontransvenous height (167.1 ± 18.9 cm; range, 53-193 cm versus 170.4 ± 13.1 cm; range, 61-203 cm; P<0.01) were lower than for transvenous patients. CHD and pediatrics had similar rates of transvenous (97%) and nontransvenous (3%) leads and did not differ from the overall registry. Transposition of the great vessels and common ventricle had higher rates of nontransvenous leads. Primary prevention exceeds secondary prevention for CHD and pediatrics. Nontransvenous lead patients were younger, with higher rates of transposition of the great vessels and common ventricle patients compared with transvenous lead patients. © 2014 American Heart Association, Inc.

Inappropriate shock delivery by implantable cardioverter defibrillator due to electrical interference with washing machine.

PubMed

Chongtham, Dhanaraj Singh; Bahl, Ajay; Kumar, Rohit Manoj; Talwar, K K

2007-05-31

We report a patient with hypertrophic cardiomyopathy who received an inappropriate implantable cardioverter defibrillator shock due to electrical interference from a washing machine. This electrical interference was detected as an episode of ventricular fibrillation with delivery of shock without warning symptoms.

Phone-Delivered Mindfulness Training for Patients with Implantable Cardioverter Defibrillators: Results of a Pilot Randomized Controlled Trial

PubMed Central

Salmoirago-Blotcher, Elena; Crawford, Sybil L.; Carmody, James; Rosenthal, Lawrence; Yeh, Gloria; Stanley, Mary; Rose, Karen; Browning, Clifford; Ockene, Ira S.

2013-01-01

Background The reduction in adrenergic activity and anxiety associated with meditation may be beneficial for patients with implantable cardioverter defibrillators. Purpose To determine the feasibility of a phone-delivered mindfulness intervention in patients with defibrillators and to obtain preliminary indications of efficacy on mindfulness and anxiety. Methods Clinically stable outpatients were randomized to a mindfulness intervention (8 weekly individual phone sessions) or to a scripted follow-up phone call. We used the Hospital Anxiety and Depression Scale and the Five Facets of Mindfulness to measure anxiety and mindfulness; and multivariate linear regression to estimate the intervention effect on pre-post intervention changes in these variables. Results We enrolled 45 patients (23 mindfulness, 22 control; age 43–83; 30 % women). Retention was 93 %; attendance was 94 %. Mindfulness (beta = 3.31; p = .04) and anxiety (beta = − 1.15; p = .059) improved in the mindfulness group. Conclusions Mindfulness training can be effectively phone-delivered and may improve mindfulness and anxiety in cardiac defibrillator outpatients. PMID:23605175

[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.

Early risk of mortality after coronary artery revascularization in patients with left ventricular dysfunction and potential role of the wearable cardioverter defibrillator.

PubMed

Zishiri, Edwin T; Williams, Sarah; Cronin, Edmond M; Blackstone, Eugene H; Ellis, Stephen G; Roselli, Eric E; Smedira, Nicholas G; Gillinov, A Marc; Glad, Jo Ann; Tchou, Patrick J; Szymkiewicz, Steven J; Chung, Mina K

2013-02-01

Implantation of implantable cardioverter defibrillator for prevention of sudden cardiac death is deferred for 90 days after coronary revascularization, but mortality may be highest early after cardiac procedures in patients with ventricular dysfunction. We determined mortality risk in postrevascularization patients with left ventricular ejection fraction ≤35% and compared survival with those discharged with a wearable cardioverter defibrillator (WCD). Hospital survivors after surgical (coronary artery bypass graft surgery) or percutaneous (percutaneous coronary intervention [PCI]) revascularization with left ventricular ejection fraction ≤35% were included from Cleveland Clinic and national WCD registries. Kaplan-Meier, Cox proportional hazards, propensity score-matched survival, and hazard function analyses were performed. Early mortality hazard was higher among 4149 patients discharged without a defibrillator compared with 809 with WCDs (90-day mortality post-coronary artery bypass graft surgery 7% versus 3%, P=0.03; post-PCI 10% versus 2%, P<0.0001). WCD use was associated with adjusted lower risks of long-term mortality in the total cohort (39%, P<0.0001) and both post-coronary artery bypass graft surgery (38%, P=0.048) and post-PCI (57%, P<0.0001) cohorts (mean follow-up, 3.2 years). In propensity-matched analyses, WCD use remained associated with lower mortality (58% post-coronary artery bypass graft surgery, P=0.002; 67% post-PCI, P<0.0001). Mortality differences were not attributable solely to therapies for ventricular arrhythmia. Only 1.3% of the WCD group had a documented appropriate therapy. Patients with left ventricular ejection fraction ≤35% have higher early compared to late mortality after coronary revascularization, particularly after PCI. As early hazard seemed less marked in WCD users, prospective studies in this high-risk population are indicated to confirm whether WCD use as a bridge to left ventricular ejection fraction improvement or

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.

A rare, late complication after automated implantable cardioverter-defibrillator placement.

PubMed

Shapiro, Michael; Hanon, Sam; Schweitzer, Paul

2004-10-01

This article describes an interesting case of automated implantable cardioverter defibrillator (AICD) extrusion fifteen months after implantation. The case report is followed by a discussion of the causes and treatment of skin erosion following pacemaker/AICD insertion.

Beam Profile Disturbances from Implantable Pacemakers or Implantable Cardioverter-Defibrillator Interactions

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

Gossman, Michael S., E-mail: mgossman@tsrcc.com; Comprehensive Heart and Vascular Associates, Heart and Vascular Center, Ashland, KY; Medtronic, Inc., External Research Program, Mounds View, MN

2011-01-01

The medical community is advocating for progressive improvement in the design of implantable cardioverter-defibrillators and implantable pacemakers to accommodate elevations in dose limitation criteria. With advancement already made for magnetic resonance imaging compatibility in some, a greater need is present to inform the radiation oncologist and medical physicist regarding treatment planning beam profile changes when such devices are in the field of a therapeutic radiation beam. Treatment plan modeling was conducted to simulate effects induced by Medtronic, Inc.-manufactured devices on therapeutic radiation beams. As a continuation of grant-supported research, we show that radial and transverse open beam profiles of amore » medical accelerator were altered when compared with profiles resulting when implantable pacemakers and cardioverter-defibrillators are placed directly in the beam. Results are markedly different between the 2 devices in the axial plane and the sagittal planes. Vast differences are also presented for the therapeutic beams at 6-MV and 18-MV x-ray energies. Maximum changes in percentage depth dose are observed for the implantable cardioverter-defibrillator as 9.3% at 6 MV and 10.1% at 18 MV, with worst distance to agreement of isodose lines at 2.3 cm and 1.3 cm, respectively. For the implantable pacemaker, the maximum changes in percentage depth dose were observed as 10.7% at 6 MV and 6.9% at 18 MV, with worst distance to agreement of isodose lines at 2.5 cm and 1.9 cm, respectively. No differences were discernible for the defibrillation leads and the pacing lead.« less

Impact of programming strategies aimed at reducing nonessential implantable cardioverter defibrillator therapies on mortality: a systematic review and meta-analysis.

PubMed

Tan, Vern Hsen; Wilton, Stephen B; Kuriachan, Vikas; Sumner, Glen L; Exner, Derek V

2014-02-01

Patients who receive implantable cardioverter defibrillator therapies are at higher risk of death versus those who do not. Programmed settings to reduce nonessential implantable cardioverter defibrillator therapies (therapy reduction programming) have been developed but may have adverse effects. This systematic review and meta-analysis assessed the relationship between therapy reduction programming with the risks of death from any cause, implantable cardioverter defibrillator shocks, and syncope. MEDLINE, EMBASE, and clinicaltrials.gov databases were searched to identify relevant studies. Those that followed patients for ≥6 months and reported mortality were included. Six met the inclusion criteria; 4 randomized (Comparison of Empiric to Physician-Tailored Programming of ICDs [EMPIRIC], Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy [MADIT-RIT], Avoid Delivering Therapies for Non-sustained Arrhythmias in ICD Patients III [ADVANCE III], and Programming Implantable Cardioverter-Defibrillators in Patients with Primary Prevention Indication to Prolong Time to First Shock [PROVIDE]) and 2 prospective studies (Role of Long Detection Window Programming in Patients With Left Ventricular Dysfunction, Non-ischemic Etiology in Primary Prevention Treated with a Biventricular ICD [RELEVANT] and Primary Prevention Parameters Evaluation [PREPARE]). These 6 studies included 7687 (3598 conventional and 4089 therapy reduction programming) patients. Most (77%) participants were men, had a history of ischemic heart disease (56%), and were prescribed β-blockers (84%). Therapy reduction programming was associated with a 30% relative reduction in mortality (95% confidence interval, 16%-41%; P<0.001). No significant heterogeneity among studies was observed (P=0.6). A similar 26% reduction in mortality was observed when only the 4 randomized trials were included (95% confidence interval, 11%-40%; P=0.002). These results were not significantly altered

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.

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.

Manual vs. automatic capture management in implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.

PubMed

Murgatroyd, Francis D; Helmling, Erhard; Lemke, Bernd; Eber, Bernd; Mewis, Christian; van der Meer-Hensgens, Judith; Chang, Yanping; Khalameizer, Vladimir; Katz, Amos

2010-06-01

The Secura ICD and Consulta CRT-D are the first defibrillators to have automatic right atrial (RA), right ventricular (RV), and left ventricular (LV) capture management (CM). Complete CM was evaluated in an implantable cardioverter defibrillator (ICD) population. Two prospective clinical studies were conducted in 28 centres in Europe and Israel. Automatic CM data were compared with manual threshold measurements, the CM applicability was determined, and adjustments to pacing outputs were analysed. In total, 160 patients [age 64.6 +/- 10.4 years, 77% male, 80 ICD and 80 cardiac resynchronization therapy defibrillator (CRT-D)] were included. The differences between automatic and manual measurements were patients. Results indicated increased output (threshold >2.5 V) due to raised RA threshold in seven (4.4%), high RV threshold in nine (5.6%), and high LV threshold in three patients (3.8%). All high threshold detections and all automatic modulations of pacing output were adjudicated appropriate. Complete CM adjusts pacing output appropriately, permitting a reduction in office visits while it may maximize device longevity. The study was registered at ClinicalTrials.gov identifiers: NCT00526227 and NCT00526162.

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.

Disparities in the use of primary prevention and defibrillator therapy among blacks and women.

PubMed

Gauri, Andre J; Davis, Andrew; Hong, Thomas; Burke, Martin C; Knight, Bradley P

2006-02-01

This study determines whether there are racial or gender disparities in the use of implantable cardioverter-defibrillator therapy for primary prevention of sudden cardiac death. Primary prevention of sudden death with implantable cardioverter-defibrillator therapy has been shown to improve survival for high-risk patients with coronary artery disease and left ventricular dysfunction. The Center for Medicare and Medicaid Services Medicare database from the year 2002 was used to identify patients who were potential candidates for implantable cardioverter-defibrillator therapy on the basis of a combination of International Classification of Diseases, Ninth Revision, Clinical Modification codes that reflected the presence of an ischemic cardiomyopathy. This cohort was analyzed to determine which patients received implantable cardioverter-defibrillator therapy during the same year. The clinical characteristics of the potential implantable cardioverter-defibrillator candidates were compared with those who actually received an implantable cardioverter-defibrillator. A total 132565 Medicare patients hospitalized during 2002 were identified as having an ischemic cardiomyopathy; 10370 (8%) of these patients underwent implantable cardioverter-defibrillator implantation during the same year. The percentage of patients who underwent implantable cardioverter-defibrillator implantation was higher for men compared with women (10.2% vs 3.5%; P<.001) and whites compared with blacks (8.1 vs 5.4; P<.001). After multivariate analysis, age, gender, and race remained independent predictors of implantable cardioverter-defibrillator implantation. Women with an ischemic cardiomyopathy were 65% less likely to receive implantable cardioverter-defibrillator therapy compared with men (P<.001), and black patients were 31% less likely to receive implantable cardioverter-defibrillator therapy compared with patients of other races (P < .001). Use of implantable cardioverter-defibrillator therapy for

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.

[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 NO Regular Defibrillation testing In Cardioverter Defibrillator Implantation (NORDIC ICD) trial: concept and design of a randomized, controlled trial of intra-operative defibrillation testing during de novo defibrillator implantation.

PubMed

Bänsch, Dietmar; Bonnemeier, Hendrik; Brandt, Johan; Bode, Frank; Svendsen, Jesper Hastrup; Felk, Angelika; Hauser, Tino; Wegscheider, Karl

2015-01-01

Although defibrillation (DF) testing is still considered a standard procedure during implantable cardioverter-defibrillator (ICD) insertion and has been an essential element of all trials that demonstrated the survival benefit of ICD therapy, there are no large randomized clinical trials demonstrating that DF testing improves clinical outcome and if the outcome would remain the same by omitting DF testing. Between February 2011 and July 2013, we randomly assigned 1077 patients to ICD implantation with (n = 540) or without (n = 537) DF testing. The intra-operative DF testing was standardized across all participating centres. After inducing a fast ventricular tachycardia (VT) with a heart rate ≥240 b.p.m. or ventricular fibrillation (VF) with a low-energy T-wave shock, DF was attempted with an initial 15 J shock. If the shock reversed the VT or VF, DF testing was considered successful and terminated. If unsuccessful, two effective 24 J shocks were administered. If DF was unsuccessful, the system was reconfigured and another DF testing was performed. An ICD shock energy of 40 J had to be programmed in all patients for treatment of spontaneous VT/VF episodes. The primary endpoint was the average efficacy of the first ICD shock for all true VT/VF episodes in each patient during follow-up. The secondary endpoints included the frequency of system revisions, total fluoroscopy, implantation time, procedural serious adverse events, and all-cause, cardiac, and arrhythmic mortality during follow-up. Home Monitoring was used in all patients to continuously monitor the system integrity, device programming and performance. The NO Regular Defibrillation testing In Cardioverter Defibrillator Implantation (NORDIC ICD) trial is one of two large prospective randomized trials assessing the effect of DF testing omission during ICD implantation. NCT01282918. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email

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

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

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.

Electromagnetic interference from welding and motors on implantable cardioverter-defibrillators as tested in the electrically hostile work site.

PubMed

Fetter, J G; Benditt, D G; Stanton, M S

1996-08-01

This study was designed to determine the susceptibility of an implanted cardioverter-defibrillator to electromagnetic interference in an electrically hostile work site environment, with the ultimate goal of allowing the patient to return to work. Normal operation of an implanted cardioverter-defibrillator depends on reliable sensing of the heart's electrical activity. Consequently, there is concern that external electromagnetic interference from external sources in the work place, especially welding equipment or motor-generator systems, may be sensed and produce inappropriate shocks or abnormal reed switch operation, temporarily suspending detection of ventricular tachycardia or ventricular fibrillation. The effects of electromagnetic interference on the operation of one type of implantable cardioverter-defibrillator (Medtronic models 7217 and 7219) was measured by using internal event counter monitoring in 10 patients operating arc welders at up to 900 A or working near 200-hp motors and 1 patient close to a locomotive starter drawing up to 400 A. The electromagnetic interference produced two sources of potential interference on the sensing circuit or reed switch operation, respectively: 1) electrical fields with measured frequencies up to 50 MHz produced by the high currents during welding electrode activation, and 2) magnetic fields produced by the current in the welding electrode and cable. The defibrillator sensitivity was programmed to the highest (most sensitive) value: 0.15 mV (model 7219) or 0.3 mV (model 7217). The ventricular tachycardia and ventricular fibrillation therapies were temporarily turned off but the detection circuits left on. None of the implanted defibrillators tested were affected by oversensing of the electric field as verified by telemetry from the detection circuits. The magnetic field from 225-A welding current produced a flux density of 1.2 G; this density was not adequate to close the reed switch, which requires approximately 10 G

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.

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.

Placement of implantable cardioverter-defibrillators in paediatric and congenital heart defect patients: a pipeline for model generation and simulation prediction of optimal configurations

PubMed Central

Rantner, Lukas J; Vadakkumpadan, Fijoy; Spevak, Philip J; Crosson, Jane E; Trayanova, Natalia A

2013-01-01

There is currently no reliable way of predicting the optimal implantable cardioverter-defibrillator (ICD) placement in paediatric and congenital heart defect (CHD) patients. This study aimed to: (1) develop a new image processing pipeline for constructing patient-specific heart–torso models from clinical magnetic resonance images (MRIs); (2) use the pipeline to determine the optimal ICD configuration in a paediatric tricuspid valve atresia patient; (3) establish whether the widely used criterion of shock-induced extracellular potential (Φe) gradients ≥5 V cm−1 in ≥95% of ventricular volume predicts defibrillation success. A biophysically detailed heart–torso model was generated from patient MRIs. Because transvenous access was impossible, three subcutaneous and three epicardial lead placement sites were identified along with five ICD scan locations. Ventricular fibrillation was induced, and defibrillation shocks were applied from 11 ICD configurations to determine defibrillation thresholds (DFTs). Two configurations with epicardial leads resulted in the lowest DFTs overall and were thus considered optimal. Three configurations shared the lowest DFT among subcutaneous lead ICDs. The Φe gradient criterion was an inadequate predictor of defibrillation success, as defibrillation failed in numerous instances even when 100% of the myocardium experienced such gradients. In conclusion, we have developed a new image processing pipeline and applied it to a CHD patient to construct the first active heart–torso model from clinical MRIs. PMID:23798492

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.

The Wearable Cardioverter Defibrillator in Nonischemic Cardiomyopathy: A US National Database Analysis.

PubMed

Salehi, Negar; Nasiri, Mojdeh; Bianco, Nicole R; Opreanu, Madalina; Singh, Vini; Satija, Vaibhav; Jhand, Aravdeep S; Karapetyan, Lilit; Safadi, Abdul Rahman; Surapaneni, Phani; Thakur, Ranjan K

2016-10-01

The wearable cardioverter defibrillator (WCD) is often used in patients at risk of sudden cardiac death (SCD) who are not yet candidates for an implantable cardioverter defibrillator (ICD). Newly diagnosed cardiomyopathy may be reversible, and a WCD may protect patients during the initial period of risk. We evaluate the benefit and compliance of the WCD in patients with nonischemic cardiomyopathy (NICM). We reviewed a national database of patients with NICM who used WCDs and who self-reported a history of excess alcohol use, although other causes of cardiomyopathy could not be excluded. The database contained demographic data, initial ejection fraction (EF), reason for WCD prescription, compliance and use data, any detected arrhythmias, therapies, and reason for discontinuing WCD. Statistical analyses were performed using SAS, version 9.3 (SAS Institute, Cary, NC). Of the 127 patients, 88% were men with a mean age of 52.6 ± 11.0 years. The mean initial EF was 19.9% ± 7.4%. Patients wore the WCD for a median of 51 days and a median daily use of 18.0 hours per day. The most common reasons for discontinuing the WCD were improvement in EF (33%) or ICD implantation (23.6%). Seven patients (5.5%) had 9 sustained ventricular arrhythmia events, which were successfully treated with 100% conversion. There were 11 deaths (8.6%) during 100 days of follow-up. No deaths resulted from WCD shock failure or undersensing. NICM may have a significant risk of ventricular arrhythmias and death in the first few months. The WCD delivered appropriate therapy in 5.5% of patients. This study suggests that a WCD may be effective temporary prophylaxis for prevention of SCD in patients with newly diagnosed NICM. Copyright © 2016 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

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

Assessing access to MRI of patients with magnetic resonance-conditional pacemaker and implantable cardioverter defibrillator systems: the Really ProMRI study design.

PubMed

Maglia, Giampiero; Curnis, Antonio; Brieda, Marco; Anaclerio, Matteo; Caccavo, Vincenzo; Bonfanti, Paolo; Melissano, Donato; Caravati, Fabrizio; Giovene, Lisa; Gargaro, Alessio

2015-10-01

Despite the fact that magnetic resonance (MR)-conditional pacemaker and lead systems have been introduced more than 5 years ago, it is still not clear whether they have actually facilitated the access of pacemaker patients to this important diagnostic tool. Factors limiting MR scans in daily practice in patients with MR-conditional cardiac implantable electronic device (CIED) systems may be related to organizational, cultural and sometimes legal aspects. The Really ProMRI registry is an ongoing survey designed to assess the annual rate of MR examinations in patients with MR-conditional implants, with either pacemakers or implantable cardioverter defibrillators, and to detect the main factors limiting MRI. The primary endpoint of the Really ProMRI registry is to assess the current access to MRI of patients with MR-conditional pacemaker or implantable cardioverter defibrillator systems during normal practice. Data in the literature reported a 17% annual incidence of medical conditions requiring MRI in CIED patients. The Really ProMRI registry has been designed to detect 4.5% absolute difference with an 80% statistical power, by recruiting 600 patients already implanted with MR-conditional CIED implant. Patients will be followed up for 1 year, during which they will be asked to refer any prescription, execution or denial of an MR examination by patient questionnaires and original source documents. The ongoing Really ProMRI registry will assess the actual rate of and factors limiting the access to MRI for patients with MR-conditional CIEDs.

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).

The wearable cardioverter-defibrillator in a real-world clinical setting: experience in 102 consecutive patients.

PubMed

Erath, Julia W; Vamos, Mate; Sirat, Abdul Sami; Hohnloser, Stefan H

2017-04-01

The wearable cardioverter-defibrillator (WCD) is used for temporary protection of patients deemed to be at high risk for sudden death (SCD) not yet meeting indications for the implantable defibrillator (ICD). To evaluate the efficacy, safety, and compliance of/to WCD use and subsequent medium-term outcome of patients in a single-center observational study. A total of 102 consecutive patients were fitted with the WCD from 2012 to 2015 and followed for a mean of 11 months (±8 months). The most common clinical indication for WCD-prescription (63%) was a new diagnosis of severely impaired LV function (LVEF ≤35%). The median wear time of the WCD was 54 days with a daily use of 23 h. Appropriate WCD therapy occurred in four patients (seven shocks for VF, one shock for VT). An ICD was finally implanted in 56 patients (55%). Improvement in LV function was the most common reason not to implant an ICD (HR 0.37; 95% CI 0.19-0.73; p = 0.004). Two patients had inappropriate shocks from their WCD due to atrial fibrillation/flutter. Five patients fitted with an ICD after the end of WCD therapy suffered VT/VF episodes. After wearing the WCD, six patients died (five ICD recipients and one non-ICD recipient). WCD therapy was well accepted by patients and provided temporary protection against ventricular tachyarrhythmias in patients at risk for SCD. The WCD may help to avoid unnecessary ICD implantations in a significant proportion of patients.

Downward delegation of implantable cardioverter defibrillator decision-making in a restricted-resource environment: the pitfalls of bedside rationing.

PubMed

Simpson, Christopher S; Hoffmaster, Barry; Dorian, Paul

2005-05-15

Implantable cardioverter defibrillators have been shown to reduce all-cause mortality in some patient populations at risk of sudden death. New Canadian guidelines recommend implantable cardioverter defibrillator therapy for these patients. However, the need for these devices exceeds the funded volumes in many Canadian jurisdictions. As a result, rationing of this resource has been necessary. While rationing at the macro (Ministry of Health) and meso (hospital) levels has achieved some level of acceptance by society, the responsibility for the decisions taken at the micro (individual) patient level actually rests with the physician at the bedside. This 'bedside rationing' creates a moral dilemma for physicians, who are torn between their traditional fiduciary role as 'patient advocate' and the competing role of 'gatekeeper'. This 'downward delegation' of rationing decision-making obscures the reality that rationing occurs, and encourages covert, opaque and inconsistent approaches. The remedy is the development of fair, legitimate procedures for making rationing decisions that include guidelines that structure and constrain those decisions. Macro- and meso-level stakeholders must also recognize and take responsibility for their part in restricting resources in a broadly inclusive and transparent process.

National experience with long-term use of the wearable cardioverter defibrillator in patients with cardiomyopathy.

PubMed

Lamichhane, Madhab; Gardiner, Joseph C; Bianco, Nicole R; Szymkiewicz, Steven J; Thakur, Ranjan K

2017-01-01

The wearable cardioverter defibrillator (WCD) is generally used for short periods of sudden cardiac death (SCD) risk; circumstances may occasionally result in prolonged use (over 1 year). The aim of this study was to determine the benefits and risks of prolonged use in patients with systolic heart failure (HF). ZOLL's post-market US database included adult patients (≥18 years) with ischemic and/or non-ischemic cardiomyopathy (ICM, NICM) and at least 1 year of use. Cox-regression was used to identify factors associated with survival with WCD use, and reasons for stopping use were entered as time-dependent factors. Among 220 patients, age (mean ± SD) 55.4 ± 14.8 years, WCD use 451.4 ± 289.9 days, and 67.3 % were male and their left ventricle ejection fraction (EF) averaged 20.9 ± 7.2 %. Eighty-nine (40.5 %) were continuing WCD use at the last follow-up. Thirty-six (16.4 %) and 56 (25.5 %) patients discontinued WCD use because of EF recovery and implantable cardioverter (ICD) implantation, respectively. Nine patients (4.1 %) received appropriate shock therapy for 13 episodes of sustained ventricular tachyarrhythmia with 12 (92.3 %) successful shocks. One patient died of refractory ventricular fibrillation. One patient died from sinus bradycardia transitioning to asystole. Eight patients (3.6 %) had nine episodes of non-fatal inappropriate shocks. Long-term use of the WCD is safe and effective. Recovery of EF was seen in significant number of patients even after 1 year of WCD use.

Diabetes Mellitus and Outcomes of Cardiac Resynchronization With Implantable Cardioverter-Defibrillator Therapy in Older Patients With Heart Failure.

PubMed

Echouffo-Tcheugui, Justin B; Masoudi, Frederick A; Bao, Haikun; Spatz, Erica S; Fonarow, Gregg C

2016-08-01

Large-scale data on outcomes with cardiac resynchronization therapy with defibrillator in patients with diabetes mellitus are limited. We compared outcomes after cardiac resynchronization therapy with defibrillator implantation among patients with heart failure who have diabetes mellitus versus those without diabetes mellitus. Survival curves and covariate adjusted hazard ratio (HR) or odds ratio were used to assess the risks for death, readmission, and device-related complications by diabetes mellitus status among 18 428 patients at least 65 years old receiving cardiac resynchronization therapy with defibrillator from the National Cardiovascular Data Registry, implantable cardioverter-defibrillator registry between 2006 and 2009, with up to 3 years of follow-up. Accounting for differences between groups, compared with those without diabetes mellitus (n=11 345), patients with diabetes mellitus (n=7083) had a higher risk of death both at 1 year (HR, 1.16 [95% confidence interval (CI), 1.05-1.29]; P=0.0037) and 3 years (HR, 1.21 [1.14-1.29]; P<0.001) after device implantation and higher risks of all-cause readmission (sub-HR, 1.16 [1.11-1.21] at 1 year; P<0.0001; sub-HR, 1.15 [1.11-1.19] at 3 years; P<0.0001) and heart failure-related readmission (sub-HR, 1.18 [1.09-1.28] at 1 year; P<0.0001; and sub-HR, 1.22 [1.15-1.30] at 3 years; P<0.0001). Device-related complications within 90 days did not differ between those with and without diabetes mellitus (odds ratio: 0.90 [0.77-1.06]; P=0.37). Interactions of age, sex, ischemic cardiomyopathy, renal failure, or QRS duration were not significant. In older patients with heart failure receiving cardiac resynchronization therapy with defibrillator, diabetes mellitus was independently associated with greater risks of death and rehospitalization, but similar risks of procedural complications. © 2016 American Heart Association, Inc.

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

Infrequent physician use of implantable cardioverter-defibrillators risks patient safety.

PubMed

Lyman, Stephen; Sedrakyan, Art; Do, Huong; Razzano, Renee; Mushlin, Alvin I

2011-10-01

Implantable cardioverter-defibrillators (ICDs) have diffused rapidly into clinical practice with little evaluation of their real-world effectiveness. To determine the effect of the adoption of ICD on patient safety, particularly with respect to physician volume and early outcomes. Retrospective cohort of all ICD implantations in New York state from 1997 to 2006, with follow-up at 90 days and 1 year. Setting New York state non-federal hospital discharges in which an ICD was implanted during the admission. Patients were followed forward for 1 year for subsequent admissions. Patients New York state residents undergoing ICD implantation. Effects of annual and career ICD implantation volume on 90-day complication, readmission, reprogramming, mortality and revision of the ICD within 1 year. This cohort (N = 38,992) represents a period of rapid adoption and implementation of this new technology, with frequency more than tripling between 1997 and 2006. We identified 6439 (16.5%) post-implantation complications and 1093 (2.8%) deaths within 90 days of implantation. The majority (73.4%) of physicians implanted one or fewer ICDs per year, and 11.0% of all implantations were performed by these very-low-volume operators. Patients treated by very-low-volume operators were more likely to die (RR = 1.8, 95% CI 1.3 to 2.4) or experience cardiac complications (RR = 4.7, 95% CI 3.3 to 6.8) even after the adjustment for case mix compared to operators who frequently performed ICD implantation. These findings suggest a need for safe and effective implementation strategies for new medical technologies, which minimize patient risk due to rapid diffusion among inexperienced providers and assure that the intended benefit can be maximised rapidly.

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.

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

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.

Battery and capacitor technology for uniform charge time in implantable cardioverter-defibrillators

NASA Astrophysics Data System (ADS)

Skarstad, Paul M.

Implantable cardioverter-defibrillators (ICDs) are implantable medical devices designed to treat ventricular fibrillation by administering a high-voltage shock directly to the heart. Minimizing the time a patient remains in fibrillation is an important goal of this therapy. Both batteries and high-voltage capacitors used in these devices can display time-dependency in performance, resulting in significant extension of charge time. Altering the electrode balance in lithium/silver vanadium oxide batteries used to power these devices has minimized time-dependent changes in battery resistance. Charge-interval dependent changes in capacitor cycling efficiency have been minimized for stacked-plate aluminum electrolytic capacitors by a combination of material and processing factors.

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.

Perceptions of healthcare professionals' support, shock anxiety and device acceptance among implantable cardioverter defibrillator recipients.

PubMed

Morken, Ingvild M; Norekvål, Tone M; Bru, Edvin; Larsen, Alf I; Karlsen, Bjørg

2014-09-01

To investigate the extent to which perceived support from healthcare professionals and shock anxiety is related to device acceptance among implantable cardioverter defibrillator recipients. Device acceptance can be influenced by several factors, one of which is shock anxiety associated with poor device acceptance. Reduced shock anxiety, as well as increased device acceptance, has been reported after psycho-educational programmes. As healthcare professionals appear to play a significant role in providing support and education during regular follow-up visits, they may constitute an important social support system that could be another factor influencing device acceptance. However, little is known about the relationship between perceived support from healthcare professionals and device acceptance among recipients. A cross-sectional survey design. A sample comprising implantable cardioverter defibrillator recipients completed questionnaires assessing perceived support from healthcare professionals, shock anxiety and device acceptance. Demographic and clinical data were collected by self-report and from medical records in September-October 2010. The descriptive results indicated that approximately 85% of the recipients experienced high device acceptance. Regression analysis demonstrated that constructive support from healthcare professionals was positively associated with device acceptance and moderated the negative relationship between shock anxiety and device acceptance. Non-constructive support and shock anxiety had a negative statistical association with device acceptance. Healthcare professionals may represent a valuable constructive support system that can enhance device acceptance among implantable cardioverter defibrillator recipients, partly by preventing shock anxiety from leading to poor device acceptance. Non-constructive communication on the part of healthcare professionals could hinder device acceptance. © 2014 John Wiley & Sons Ltd.

The oral cavity is not a primary source for implantable pacemaker or cardioverter defibrillator infections

PubMed Central

2013-01-01

Background To test the hypothesis that the oral cavity is a potential source for implantable pacemaker and cardioverter defibrillators infections, the bacterial diversity on explanted rhythm heart management devices was investigated and compared to the oral microbiome. Methods A metagenomic approach was used to analyze the bacterial diversity on the surfaces of non-infected and infected pacemakers. The DNA from surfaces swaps of 24 non-infected and 23 infected pacemaker were isolated and subjected to bacterial-specific DNA amplification, single strand conformation polymorphism- (SSCP) and sequencing analysis. Species-specific primer sets were used to analyze for any correlation between bacterial diversity on pacemakers and in the oral cavity. Results DNA of bacterial origin was detected in 21 cases on infected pacemakers and assigned to the bacterial phylotypes Staphylococcus epidermidis, Propionibacterium acnes, Staphylococcus aureus, Staphylococcus schleiferi and Stapyhlococcus. In 17 cases bacterial DNA was found on pacemakers with no clinical signs of infections. On the basis of the obtained sequence data, the phylotypes Propionibacterium acnes, Staphylococcus and an uncultured bacterium were identified. Propionibacterium acnes and Staphylococcus epidermidis were the only bacteria detected in pacemeaker (n = 25) and oral samples (n = 11). Conclusions The frequency of the coincidental detection of bacteria on infected devices and in the oral cavity is low and the detected bacteria are highly abundant colonizers of non-oral human niches. The transmission of oral bacteria to the lead or device of implantable pacemaker or cardioverter defibrillators is unlikely relevant for the pathogenesis of pacemaker or cardioverter defibrillators infections. PMID:23575037

Magnetic resonance imaging safety in pacemaker and implantable cardioverter defibrillator patients: how far have we come?

PubMed Central

Nordbeck, Peter; Ertl, Georg; Ritter, Oliver

2015-01-01

Magnetic resonance imaging (MRI) has long been regarded a general contraindication in patients with cardiovascular implanted electronic devices such as cardiac pacemakers or cardioverter defibrillators (ICDs) due to the risk of severe complications and even deaths caused by interactions of the magnetic resonance (MR) surrounding and the electric devices. Over the last decade, a better understanding of the underlying mechanisms responsible for such potentially life-threatening complications as well as technical advances have allowed an increasing number of pacemaker and ICD patients to safely undergo MRI. This review lists the key findings from basic research and clinical trials over the last 20 years, and discusses the impact on current day clinical practice. With ‘MR-conditional’ devices being the new standard of care, MRI in pacemaker and ICD patients has been adopted to clinical routine today. However, specific precautions and specifications of these devices should be carefully followed if possible, to avoid patient risks which might appear with new MR technology and further increasing indications and patient numbers. PMID:25796053

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.

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

Automatic external defibrillator, life vest defibrillator, or both?

PubMed

Richard Conti, C

2010-12-01

The standard of practice for out-of-hospital defibrillation is the implantable cardioverter-defibrillator. However, much has been written and discussed about the use of automated external defibrillators. Not as much has been written about life vest wearable defibrillators. Copyright © 2010 Wiley Periodicals, Inc.

Performance of the 2015 International Task Force Consensus Statement Risk Stratification Algorithm for Implantable Cardioverter-Defibrillator Placement in Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy.

PubMed

Orgeron, Gabriela M; Te Riele, Anneline; Tichnell, Crystal; Wang, Weijia; Murray, Brittney; Bhonsale, Aditya; Judge, Daniel P; Kamel, Ihab R; Zimmerman, Stephan L; Tandri, Harikrishna; Calkins, Hugh; James, Cynthia A

2018-02-01

Ventricular arrhythmias are a feared complication of arrhythmogenic right ventricular dysplasia/cardiomyopathy. In 2015, an International Task Force Consensus Statement proposed a risk stratification algorithm for implantable cardioverter-defibrillator placement in arrhythmogenic right ventricular dysplasia/cardiomyopathy. To evaluate performance of the algorithm, 365 arrhythmogenic right ventricular dysplasia/cardiomyopathy patients were classified as having a Class I, IIa, IIb, or III indication per the algorithm at baseline. Survival free from sustained ventricular arrhythmia (VT/VF) in follow-up was the primary outcome. Incidence of ventricular fibrillation/flutter cycle length <240 ms was also assessed. Two hundred twenty-four (61%) patients had a Class I implantable cardioverter-defibrillator indication; 80 (22%), Class IIa; 54 (15%), Class IIb; and 7 (2%), Class III. During a median 4.2 (interquartile range, 1.7-8.4)-year follow-up, 190 (52%) patients had VT/VF and 60 (16%) had ventricular fibrillation/flutter. Although the algorithm appropriately differentiated risk of VT/VF, incidence of VT/VF was underestimated (observed versus expected: 29.6 [95% confidence interval, 25.2-34.0] versus >10%/year Class I; 15.5 [confidence interval 11.1-21.6] versus 1% to 10%/year Class IIa). In addition, the algorithm did not differentiate survival free from ventricular fibrillation/flutter between Class I and IIa patients ( P =0.97) or for VT/VF in Class I and IIa primary prevention patients ( P =0.22). Adding Holter results (<1000 premature ventricular contractions/24 hours) to International Task Force Consensus classification differentiated risks. While the algorithm differentiates arrhythmic risk well overall, it did not distinguish ventricular fibrillation/flutter risks of patients with Class I and IIa implantable cardioverter-defibrillator indications. Limited differentiation was seen for primary prevention cases. As these are vital uncertainties in clinical decision

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

PubMed

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

2015-02-01

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

Safety of the Wearable Cardioverter Defibrillator (WCD) in Patients with Implanted Pacemakers.

PubMed

Schmitt, Joern; Abaci, Guezine; Johnson, Victoria; Erkapic, Damir; Gemein, Christopher; Chasan, Ritvan; Weipert, Kay; Hamm, Christian W; Klein, Helmut U

2017-03-01

The wearable cardioverter defibrillator (WCD) is an important approach for better risk stratification, applied to patients considered to be at high risk of sudden arrhythmic death. Patients with implanted pacemakers may also become candidates for use of the WCD. However, there is a potential risk that pacemaker signals may mislead the WCD detection algorithm and cause inappropriate WCD shock delivery. The aim of the study was to test the impact of different types of pacing, various right ventricular (RV) lead positions, and pacing modes for potential misleading of the WCD detection algorithm. Sixty patients with implanted pacemakers received the WCD for a short time and each pacing mode (AAI, VVI, and DDD) was tested for at least 30 seconds in unipolar and bipolar pacing configuration. In case of triggering the WCD detection algorithm and starting the sequence of arrhythmia alarms, shock delivery was prevented by pushing of the response buttons. In six of 60 patients (10%), continuous unipolar pacing in DDD mode triggered the WCD detection algorithm. In no patient, triggering occurred with bipolar DDD pacing, unipolar and bipolar AAI, and VVI pacing. Triggering was independent of pacing amplitude, RV pacing lead position, and pulse generator implantation site. Unipolar DDD pacing bears a high risk of false triggering of the WCD detection algorithm. Other types of unipolar pacing and all bipolar pacing modes do not seem to mislead the WCD detection algorithm. Therefore, patients with no reprogrammable unipolar DDD pacing should not become candidates for the WCD. © 2016 Wiley Periodicals, Inc.

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.

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.

Genome-Wide Association of Implantable Cardioverter-Defibrillator Activation With Life-Threatening Arrhythmias

PubMed Central

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

Objectives 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). Background Most individuals that receive implantable cardioverter-defibrillators never experience a life-threatening arrhythmia. Genetic factors may help identify who is most at risk. Methods 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. Results and Conclusions 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. Trial Registration ClinicalTrials.gov NCT00664807 PMID:22247754

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

Comparative Evaluation of Four Risk Scores for Predicting Mortality in Patients With Implantable Cardioverter-defibrillator for Primary Prevention.

PubMed

Rodríguez-Mañero, Moisés; Abu Assi, Emad; Sánchez-Gómez, Juan Miguel; Fernández-Armenta, Juan; Díaz-Infante, Ernesto; García-Bolao, Ignacio; Benezet-Mazuecos, Juan; Andrés Lahuerta, Ana; Expósito-García, Víctor; Bertomeu-González, Vicente; Arce-León, Álvaro; Barrio-López, María Teresa; Peinado, Rafael; Martínez-Sande, Luis; Arias, Miguel A

2016-11-01

Several clinical risk scores have been developed to identify patients at high risk of all-cause mortality despite implantation of an implantable cardioverter-defibrillator. We aimed to examine and compare the predictive capacity of 4 simple scoring systems (MADIT-II, FADES, PACE and SHOCKED) for predicting mortality after defibrillator implantation for primary prevention of sudden cardiac death in a Mediterranean country. A multicenter retrospective study was performed in 15 Spanish hospitals. Consecutive patients referred for defibrillator implantation between January 2010 and December 2011 were included. A total of 916 patients with ischemic and nonischemic heart disease were included (mean age, 62 ± 11 years, 81.4% male). Over 33.4 ± 12.9 months, 113 (12.3%) patients died (cardiovascular origin in 86 [9.4%] patients). At 12, 24, 36, and 48 months, mortality rates were 4.5%, 7.6%, 10.8%, and 12.3% respectively. All the risk scores showed a stepwise increase in the risk of death throughout the scoring system of each of the scores and all 4 scores identified patients at greater risk of mortality. The scores were significantly associated with all-cause mortality throughout the follow-up period. PACE displayed the lowest c-index value regardless of whether the population had heart disease of ischemic (c-statistic = 0.61) or nonischemic origin (c-statistic = 0.61), whereas MADIT-II (c-statistic = 0.67 and 0.65 in ischemic and nonischemic cardiomyopathy, respectively), SHOCKED (c-statistic = 0.68 and 0.66, respectively), and FADES (c-statistic = 0.66 and 0.60) provided similar c-statistic values (P ≥ .09). In this nontrial-based cohort of Mediterranean patients, the 4 evaluated risk scores showed a significant stepwise increase in the risk of death. Among the currently available risk scores, MADIT-II, FADES, and SHOCKED provide slightly better performance than PACE. Copyright © 2016 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All

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

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.

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.

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.

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.

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

Ventricular arrhythmias and changes in heart rate preceding ventricular tachycardia in patients with an implantable cardioverter defibrillator.

PubMed

Lerma, Claudia; Wessel, Niels; Schirdewan, Alexander; Kurths, Jürgen; Glass, Leon

2008-07-01

The objective was to determine the characteristics of heart rate variability and ventricular arrhythmias prior to the onset of ventricular tachycardia (VT) in patients with an implantable cardioverter defibrillator (ICD). Sixty-eight beat-to-beat time series from 13 patients with an ICD were analyzed to quantify heart rate variability and ventricular arrhythmias. The episodes of VT were classified in one of two groups depending on whether the sinus rate in the 1 min preceding the VT was greater or less than 90 beats per minute. In a subset of patients, increased heart rate and reduced heart rate variability was often observed up to 20 min prior to the VT. There was a non-significant trend to higher incidence of premature ventricular complexes (PVCs) before VT compared to control recordings. The patterns of the ventricular arrhythmias were highly heterogeneous among different patients and even within the same patient. Analysis of the changes of heart rate and heart rate variability may have predictive value about the onset of VT in selected patients. The patterns of ventricular arrhythmia could not be used to predict onset of VT in this group of patients.

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.

Perceived support from healthcare professionals, shock anxiety and post-traumatic stress in implantable cardioverter defibrillator recipients.

PubMed

Morken, Ingvild M; Bru, Edvin; Norekvål, Tone M; Larsen, Alf I; Idsoe, Thormod; Karlsen, Bjørg

2014-02-01

To investigate (1) the extent to which shock anxiety and perceived support from healthcare professionals are related to post-traumatic stress disease (PTSD) symptoms and (2) the extent to which perceived support from healthcare professionals moderates the relationship between shock anxiety and PTSD symptoms in implantable cardioverter defibrillator recipients. An additional aim was to describe the level of PTSD symptoms and perceptions of support from healthcare professionals. Studies examining PTSD symptoms among implantable cardioverter defibrillator recipients are still sparse. In addition, little is known about how perceived support from healthcare professionals is related to PTSD symptoms. Cross-sectional survey design. Recipients (n = 167) with implantable cardioverter defibrillator attending an outpatient device clinic completed questionnaires assessing shock anxiety, PTSD symptoms and perceived support from healthcare professionals. The results indicated that between ten and 15% of the recipients experienced moderate to severe symptoms of PTSD. Although a majority perceived constructive support from healthcare professionals, 12% perceived nonconstructive support. Regression analysis demonstrated that shock anxiety and perceived nonconstructive support from healthcare professionals had a statistically significant (p < 0·01) association with PTSD symptoms. Moreover, the results suggest that associations between shock anxiety and PTSD symptoms were significantly (p < 0·01) moderated by perceived nonconstructive support from healthcare professionals. Young age, short time since implantation and secondary prevention indication were also significantly associated with PTSD symptoms. The results indicate that nonconstructive support from healthcare professionals can increase the tendency to develop PTSD symptoms, particularly in those who experience shock anxiety. Healthcare professionals should pay more attention to the way in which they communicate information

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.

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.

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

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

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.

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.

"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.

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.

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.

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.

Antitachycardia pacing programming in implantable cardioverter defibrillator: A systematic review.

PubMed

De Maria, Elia; Giacopelli, Daniele; Borghi, Ambra; Modonesi, Letizia; Cappelli, Stefano

2017-05-26

Implantable cardioverter defibrillator (ICD) programming involves several parameters. In recent years antitachycardia pacing (ATP) has gained an increasing importance in the treatment of ventricular arrhythmias, whether slow or fast. It reduces the number of unnecessary and inappropriate shocks and improves both patient's quality of life and device longevity. There is no clear indication regarding the type of ATP to be used, except for the treatment of fast ventricular tachycardias (188 bpm-250 bpm) where it has been shown a greater efficacy and safety of burst compared to ramp; 8 impulses in each sequence of ATP appears to be the best programming option in this setting. Beyond ATP use, excellent clinical results were obtained with programming standardization following these principles: extended detection time in ventricular fibrillation (VF) zone; supraventricular discrimination criteria up to 200 bpm; first shock in VF zone at the maximum energy in order to reduce the risk of multiple shocks. The MADIT-RIT trial and some observational registries have also recently demonstrated that programming with a widespread use of ATP, higher cut-off rates or delayed intervention reduces the number of inappropriate and unnecessary therapies and improves the survival of patients during mid-term follow-up.

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.

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.

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.

Determining the risks of clinically indicated nonthoracic magnetic resonance imaging at 1.5 T for patients with pacemakers and implantable cardioverter-defibrillators: rationale and design of the MagnaSafe Registry.

PubMed

Russo, Robert J

2013-03-01

Until recently, the presence of a permanent pacemaker or an implantable cardioverter-defibrillator has been a relative contraindication for the performance of magnetic resonance imaging (MRI). A number of small studies have shown that MRI can be performed with minimal risk when patients are properly monitored and device programming is modified appropriately for the procedure. However, the risk of performing MRI for patients with implanted cardiac devices has not been sufficiently evaluated to advocate routine clinical use. The aim of the present protocol is to prospectively determine the rate of adverse clinical events and device parameter changes in patients with implanted non-MRI-conditional cardiac devices undergoing clinically indicated nonthoracic MRI at 1.5 T. The MagnaSafe Registry is a multicenter, prospective cohort study of up to 1500 MRI examinations in patients with pacemakers or implantable cardioverter-defibrillators implanted after 2001 who undergo clinically indicated nonthoracic MRI following a specific protocol to ensure that preventable potential adverse events are mitigated. Adverse events and changes in device parameter measurements that may be associated with the imaging procedure will be documented. Through August 2012, 701 MRI studies have been performed, representing 47% of the total target enrollment. The results of this registry will provide additional documentation of the risk of MRI and will further validate a clinical protocol for screening and the performance of clinically indicated MRI for patients with implanted cardiac devices. Copyright © 2013 Mosby, Inc. All rights reserved.

Guidelines on the management of implantable cardioverter defibrillators at the end of life.

PubMed

Datino, T; Rexach, L; Vidán, M T; Alonso, A; Gándara, Á; Ruiz-García, J; Fontecha, B; Martínez-Sellés, M

2014-01-01

This article is a joint document of the Spanish Society of Geriatrics and Gerontology, the Spanish Society of Palliative Care and the Section of Geriatric Cardiology of the Spanish Society of Cardiology. Its aim is to address the huge gap that exists in Spain with regard to the management of implantable cardioverter defibrillators (ICDs) in the final stages of life. It is increasingly common to find patients carrying these devices that are in the terminal stage of an advanced disease. This occurs in patients with advanced heart disease and subsequent heart failure refractory to treatment but also in a patient with an ICD who develops cancer disease, organ failure or other neurodegenerative diseases with poor short-term prognosis. The vast majority of these patients are over 65, so the paper focuses particularly on the elderly who are in this situation, but the decision-making process is similar in younger patients with ICDs who are in the final phase of their life. Copyright © 2013 Elsevier España, S.L. All rights reserved.

[Guidelines on the management of implantable cardioverter defibrillators at the end of life].

PubMed

Datino, T; Rexach, L; Vidán, M T; Alonso, A; Gándara, Á; Ruiz-García, J; Fontecha, B; Martínez-Sellés, M

2014-01-01

This article is a joint document of the Spanish Society of Geriatrics and Gerontology, the Spanish Society of Palliative Care and the Section of Geriatric Cardiology of the Spanish Society of Cardiology. Its aim is to address the huge gap that exists in Spain with regard to the management of implantable cardioverter defibrillators (ICDs) in the final stages of life. It is increasingly common to find patients carrying these devices that are in the terminal stage of an advanced disease. This occurs in patients with advanced heart disease and subsequent heart failure refractory to treatment but also in a patient with an ICD who develops cancer disease, organ failure or other neurodegenerative diseases with poor short-term prognosis. The vast majority of these patients are over 65, so the paper focuses particularly on the elderly who are in this situation, but the decision-making process is similar in younger patients with ICDs who are in the final phase of their life. Copyright © 2013 SEGG. Published by Elsevier Espana. All rights reserved.

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.

Results of ENHANCED Implantable Cardioverter Defibrillator Programming to Reduce Therapies and Improve Quality of Life (from the ENHANCED-ICD Study).

PubMed

Mastenbroek, Mirjam H; Pedersen, Susanne S; van der Tweel, Ingeborg; Doevendans, Pieter A; Meine, Mathias

2016-02-15

Novel implantable cardioverter defibrillator (ICD) discrimination algorithms and programming strategies have significantly reduced the incidence of inappropriate shocks, but there are still gains to be made with respect to reducing appropriate but unnecessary antitachycardia pacing (ATP) and shocks. We examined whether programming a number of intervals to detect (NID) of 60/80 for ventricular tachyarrhythmia (VT)/ventricular fibrillation (VF) detection was safe and the impact of this strategy on (1) adverse events related to ICD shocks and syncopal events; (2) ATPs/shocks; and (3) patient-reported outcomes. The "ENHANCED Implantable Cardioverter Defibrillator programming to reduce therapies and improve quality of life" study (ENHANCED-ICD study) was a prospective, safety-monitoring study enrolling 60 primary and secondary prevention patients at the University Medical Center Utrecht. Patients implanted with any type of ICD with SmartShock technology and aged 18 to 80 years were eligible to participate. In all patients, a prolonged NID 60/80 was programmed. The cycle length for VT/fast VT/VF was 360/330/240 ms, respectively. Programming a NID 60/80 proved safe for ICD patients. Because of the new programming strategy, unnecessary ICD therapy was prevented in 10% of ENHANCED-ICD patients during a median follow-up period of 1.3 years. With respect to patient-reported outcomes, levels of distress were highest and perceived health status lowest at the time of implantation, which both gradually improved during follow-up. In conclusion, the ENHANCED-ICD study demonstrates that programming a NID 60/80 for VT/VF detection is safe for ICD patients and does not negatively impact their quality of life. Copyright © 2016 Elsevier Inc. All rights reserved.

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.

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

The patient perspective on remote monitoring of patients with an implantable cardioverter defibrillator: Narrative review and future directions.

PubMed

Timmermans, Ivy; Meine, Matias; Zitron, Edgar; Widdershoven, Jos; Kimman, Geert; Prevot, Sébastien; Rauwolf, Thomas; Anselme, Frédéric; Szendey, Istvan; Romero Roldán, Javier; Mabo, Philippe; Schaer, Beat; Denollet, Johan; Versteeg, Henneke

2017-07-01

Studies have shown that remote patient monitoring (RPM) of implantable cardioverter defibrillators (ICDs) is at least comparable to in-clinic follow-up with regard to clinical outcomes and might be cost-effective, yet RPM is not standard clinical practice within Europe. Better insight into the patient perspective on RPM may aid in its acceptance, implementation, and reimbursement. This narrative review (1) summarizes existing evidence on the impact of RPM on patient-reported outcomes and (2) discusses future directions in examining the patient perspective. Literature review indicated that only five randomized trials on RPM in ICD patients included patient-reported outcomes, with inconclusive results. Observational studies show a trend toward good patient satisfaction and acceptation of RPM. Yet, results should be interpreted with caution due to a number of limitations including a potential selection bias, use of generic/nonvalidated questionnaires, relatively short follow-up durations, and a lack of subgroup identification. Although RPM seems to be safe, effective, timely, and efficient, the patient perspective has received little attention so far. The scarce evidence on patient-reported outcomes in RPM studies seems to be positive, but future trials with a follow-up of ≥12 months and validated patient-reported outcome measures are needed. The REMOTE-CIED study from our group is the first prospective randomized controlled trial primarily designed to examine the patient perspective on RPM, and is powered to identify characteristics associated with RPM satisfaction and benefit. Results are expected in 2018 and will add valuable information to the current evidence. © 2017 Wiley Periodicals, Inc.

Implantable Cardioverter Defibrillators. Prophylactic Use

PubMed Central

2005-01-01

of evidence for each outcome. The balance between benefits and harms, quality of evidence, applicability, and the certainty of the baseline risks are considered in judgments about the strength of recommendations. Summary of Findings Overall, ICDs are effective for the primary prevention of SCD. Three studies – the Multicentre Automatic Defibrillator Implantation Trial I (MADIT I), the Multicentre Automatic Defibrillator Implantation Trial II (MADIT II), and SCD-HeFT – showed there was a statistically significant decrease in total mortality for patients who prophylactically received an ICD compared with those who received conventional therapy (Table 1). Table 1: Results of Key Studies on the Use of Implantable Cardioverter Defibrillators for the Primary Prevention of Sudden Cardiac Death – All-Cause Mortality Study, * Year Population N Follow-up, Months Mortality, ICD† Group, % Mortality, Control Group, % Hazard Ratio (95% CI) P NNT† MADIT, 1996 (2) Ischemic 196 27 15.8 38.6 0.46 (0.26–0.82) .009 4 Priormyocardialinfarction Conventional therapy 54% relative reduction Ejection fraction ≤ 0.35NSVT†EP† + MADIT II, 2002 (3) Ischemic 1232 20 14.2 19.8 0.69(0.51–0.93) .016 18 Priormyocardialinfarction Conventional therapy 31% relative reduction Ejection fraction ≤ 0.30 SCD-HeFT, 2005 (4) Ischemic & Nonischemic 2521 60 22 29 0.77 (0.62–0.96) .007 13 Optimal therapy Ejection fraction < 0.35 23% relative reduction * MADIT I: Multicentre Automatic Defibrillator Implantation Trial I; MADIT II: Multicentre Automatic Defibrillator Implantation Trial II; SCD-HeFT: Sudden Cardiac Death in Heart Failure Trial. † EP indicates electrophysiology; ICD, implantable cardioverter defibrillator; NNT, number needed to treat; NSVT, nonsustained ventricular tachycardia. The NNT will appear higher if follow-up is short. For ICDs, the absolute benefit increases over time for at least a 5-year period; the NNT declines, often substantially, in studies with a longer follow

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.

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.

[Magnets, pacemaker and defibrillator: fatal attraction?].

PubMed

Bergamin, C; Graf, D

2015-05-27

This article aims at clarifying the effects of a clinical magnet on pacemakers and Implantable Cardioverter Defibrillators. The effects of electromagnetic interferences on such devices, including interferences linked to electrosurgery and magnetic resonance imaging are also discussed. In general, a magnet provokes a distinctive effect on a pacemaker by converting it into an asynchronous mode of pacing, and on an Implantable Cardioverter Defibrillator by suspending its own antitachyarythmia therapies without affecting the pacing. In the operating room, the magnet has to be used cautiously with precisely defined protocols which respect the type of the device used, the type of intervention planned, the presence or absence of EMI and the pacing-dependency of the patient.

Exploratory and Confirmatory Factor Analysis of the Decision Regret Scale in Recipients of Internal Cardioverter Defibrillators

PubMed Central

Hickman, Ronald L.; Pinto, Melissa D.; Lee, Eunsuk; Daly, Barbara J.

2015-01-01

The Decision Regret Scale (DRS) is a five-item instrument that captures an individual’s regret associated with a healthcare decision. Cross-sectional data were collected from 109 cardiac patients who decided to receive an internal cardioverter defibrillator (ICD). Exploratory and confirmatory factor analyses, assessments of the internal reliability consistency (α = .86), and discriminant validity established the DRS as a reliable and valid measure of decision regret in ICD recipients. The DRS, a psychometrically sound instrument, has relevance for clinicians and researchers vested in optimizing the decisional outcomes of ICD recipients. Future research is needed to examine the reliability and validity of the DRS in a larger and more diverse sample of ICD recipients. PMID:22679707

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.  

Automatic remote monitoring utilizing daily transmissions: transmission reliability and implantable cardioverter defibrillator battery longevity in the TRUST trial.

PubMed

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

2018-04-01

Benefits of automatic remote home monitoring (HM) among implantable cardioverter defibrillator (ICD) patients may require high transmission frequency. However, transmission reliability and effects on battery longevity remain uncertain. We hypothesized that HM would have high transmission success permitting punctual guideline based follow-up, and improve battery longevity. This was tested in the prospective randomized TRUST trial. Implantable cardioverter defibrillator patients were randomized post-implant 2:1 to HM (n = 908) (transmit daily) or to Conventional in-person monitoring [conventional management (CM), n = 431 (HM disabled)]. In both groups, five evaluations were scheduled every 3 months for 15 months. Home Monitoring technology performance was assessed by transmissions received vs. total possible, and number of scheduled HM checks failing because of missed transmissions. Battery longevity was compared in HM vs. CM at 15 months, and again in HM 3 years post-implant using continuously transmitted data. Transmission success per patient was 91% (median follow-up of 434 days). Overall, daily HM transmissions were received in 315 795 of a potential 363 450 days (87%). Only 55/3759 (1.46%) of unsuccessful scheduled evaluations in HM were attributed to transmission loss. Shock frequency and pacing percentage were similar in HM vs. CM. Fifteen month battery longevity was 12% greater in HM (93.2 ± 8.8% vs. 83.5 ± 6.0% CM, P < 0.001). In extended follow-up of HM patients, estimated battery longevity was 50.9 ± 9.1% (median 52%) at 36 months. Automatic remote HM demonstrated robust transmission reliability. Daily transmission load may be sustained without reducing battery longevity. Home Monitoring conserves battery longevity and tracks long term device performance. ClinicalTrials.gov; NCT00336284.

Pacemakers and implantable cardioverter defibrillators: device longevity is more important than smaller size: the patient's viewpoint.

PubMed

Wild, David M; Fisher, John D; Kim, Soo G; Ferrick, Kevin J; Gross, Jay N; Palma, Eugen C

2004-11-01

The size of pacemakers and implantable cardioverter defibrillators (ICDs) has been diminishing progressively. If two devices are otherwise identical in components, features and technology, the one with a larger battery should have a longer service life. Therefore, patients who receive smaller devices may require more frequent surgery to replace the devices. It is uncertain whether this tradeoff for smaller size is desired by patients. We surveyed 156 patients to determine whether patients prefer a larger, longer-lasting device, or a smaller device that is less noticeable but requires more frequent surgery. The effects of subgroups were evaluated; these included body habitus, age, gender, and patients seen at time of pulse generator replacement (PGR), initial implant, or follow-up. Among 156 patients surveyed, 151 expressed a preference. Of these, 90.1% preferred the larger device and 9.9% the smaller device (P <0.0001). Among thin patients, 79.5% preferred a larger device. Ninety percent of males and 89.2% of females selected the larger device. Among younger patients (< or =72 years), 89.6% preferred the larger device, as did 90.5% of older patients (>72 years). Of patients undergoing PGR or initial implants, 95% favored the larger device, as did 86% of patients presenting for follow-up. The vast majority of patients prefer a larger device to reduce the number of potential replacement operations. This preference crosses the spectrum of those with a previously implanted device, those undergoing initial implants, those returning for routine follow-up, and patients of various ages, gender, and habitus.

Effect of Sleep-Disordered Breathing on Appropriate Implantable Cardioverter-defibrillator Therapy in Patients With Heart Failure

PubMed Central

Kwon, Younghoon; Koene, Ryan J.; Kwon, Osung; Kealhofer, Jessica V.; Adabag, Selcuk; Duval, Sue

2017-01-01

Background Patients with heart failure and reduced ejection fraction are at increased risk of malignant ventricular arrhythmias. Implantable cardioverter-defibrillator (ICD) is recommended to prevent sudden cardiac death in some of these patients. Sleep-disordered breathing (SDB) is highly prevalent in this population and may impact arrhythmogenicity. We performed a systematic review and meta-analysis of prospective studies that assessed the impact of SDB on ICD therapy. Methods and Results Relevant prospective studies were identified in the Ovid MEDLINE, EMBASE, and Google Scholar databases. Weighted risk ratios of the association between SDB and appropriate ICD therapies were estimated using random effects meta-analysis. Nine prospective cohort studies (n=1274) were included in this analysis. SDB was present in 52% of the participants. SDB was associated with a 55% higher risk of appropriate ICD therapies (45% versus 28%; risk ratio, 1.55; 95% confidence interval, 1.32–1.83). In a subgroup analysis based on the subtypes of SDB, the risk was higher in both central (risk ratio, 1.50; 95% confidence interval, 1.11–2.02) and obstructive (risk ratio, 1.43; 95% confidence interval, 1.01–2.03) sleep apnea. Conclusions SDB is associated with an increased risk of appropriate ICD therapy in patients with heart failure and reduced ejection fraction. PMID:28213507

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.

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.

Uncovering phantom shocks in cardiac patients with an implantable cardioverter defibrillator.

PubMed

Bilanovic, Ana; Irvine, Jane; Kovacs, Adrienne H; Hill, Ann; Cameron, Doug; Katz, Joel

2013-06-01

Implantable cardioverter defibrillator recipients sometimes report "phantom shocks" (PSs), defined as a reported shock lacking objective evidence. The aim of this study was to describe the subjective experience of PSs and their psychosocial correlates using a mixed methods approach. PS participants were matched on sex and age with individuals who received objective shocks only (OSO). Participants were interviewed and completed measures of posttraumatic stress disorder (PTSD Checklist-Civilian Version), depression and anxiety (Hospital Anxiety and Depression Scale), disease-specific distress (Cardiac Anxiety Questionnaire-CAQ), and social desirability (Socially Desirable Response Set-SDRS). Interviews were analyzed using interpretative phenomenological analysis (IPA). Seventeen male patients participated (PS: n = 9; OSO: n = 8). Three themes emerged from IPA: (1) PS as a somatic experience, (2) the emotional impact of PSs, and (3) searching for meaning. Quantitative analyses showed that both groups exhibited elevated trauma and anxiety levels. Effect size differences (ESD) suggested a medium ESD on depression (P = 0.176, ηp (2) = 0.118) and PTSD (avoidance: P = 0.383, ηp (2) = 0.055, numbing: P = 0.311, ηp (2) = 0.068), and a large ESD on SDRS (P = 0.081, ηp (2) = 0.189), where PS participants, comparatively, exhibited elevated levels. A medium ESD was detected on CAQ-fear (P = 0.237, ηp (2) = 0.092) where OSO participants exhibited greater heart-focused worry. The qualitative and quantitative findings of this mixed method study show convergence in terms of the emotional factors associated with the experience of PSs. PSs are often reported to be indistinguishable from objective shocks, evoking alarm, frustration, and confusion, forcing the individual to face the uncertainties of what to them is a novel and confusing experience. ©2013, The Authors. Journal compilation ©2013 Wiley Periodicals, Inc.

Safety of sports participation in patients with implantable cardioverter defibrillators: a survey of heart rhythm society members.

PubMed

Lampert, Rachel; Cannom, David; Olshansky, Brian

2006-01-01

Safety of Sports for ICD Patients. The safety of sports participation for patients with implantable cardioverter defibrillators (ICDs) is unknown, and recommendations among physicians may vary widely. The purposes of this study were to determine current practice among patients with ICDs and their physicians regarding sports participation, and to determine how many physicians have cared for patients who have sustained adverse events during sports participation. A survey was mailed to all 1,687 U.S. physician members of the Heart Rhythm Society. Among 614 respondent physicians, recommendations varied widely. Only 10% recommended avoidance of all sports more vigorous than golf. Seventy-six percent recommended avoidance of contact, and 45% recommend avoidance of competitive sports. Most (71%) based restrictions on patients' underlying heart disease. Regardless of recommendations, most physicians (71%) reported caring for patients who participated in sports, including many citing vigorous, competitive sports, most commonly cited were basketball, running, and skiing. ICD shocks during sports were common, cited by 40% of physicians. However, few adverse consequences were reported. One percent of physicians reported known injury to patient (all but 3 minor); 5%, injury to the ICD system, and <1%, failure of shocks to terminate arrhythmia. The most common adverse event reported was lead damage attributed to repetitive-motion activities, most commonly weightlifting and golf. Physician recommendations for sports participation for patients with ICDs varies widely. Many patients with ICDs do participate in vigorous and even competitive sports. While shocks were common, significant adverse events were rare.

Outcomes after asystole events occurring during wearable defibrillator-cardioverter use.

PubMed

Liang, Jackson J; Bianco, Nicole R; Muser, Daniele; Enriquez, Andres; Santangeli, Pasquale; D'Souza, Benjamin A

2018-04-26

To examine whether wearable cardioverter defibrillator (WCD) alarms for asystole improve patient outcomes and survival. All asystole episodes recorded by the WCD in 2013 were retrospectively analyzed from a database of device and medical record documentation and customer call reports. Events were classified as asystole episodes if initial presenting arrhythmia was asystole (< 10 beats/minor ≥ 5 s pause). Survival was defined as recovery at the scene or arrival to a medical facility alive, or not requiring immediate medical attention. Episodes occurring in hospitals, nursing homes, or ambulances were considered to be under medical care. Serious asystole episodes were defined as resulting in unconsciousness, hospital transfer, or death. Of the total 51933 patients having worn the WCD in 2013, there were 257 patients (0.5%) who had asystole episodes and comprised the study cohort. Among the 257 patients (74% male, median age 69 years), there were 264 asystole episodes. Overall patient survival was 42%. Most asystoles were considered "serious" ( n = 201 in 201 patients, 76%), with a 26% survival rate. All 56 patients with "non-serious" asystole episodes survived. Being under medical care was associated with worse survival of serious asystoles. Among acute survivors, 20% later died during WCD use (a median 4 days post asystole episode). Of the 86 living patients at the end of WCD use period, 48 (56%) received ICD/pacemaker and 17 (20%) improved their condition. Survival rates after asystole in patients with WCD are higher than historically reported survival rates. Those under medical care at time of asystole exhibited lower survival.

Digoxin Is Associated With Increased Shock Events and Electrical Storms in Patients With Implantable Cardioverter Defibrillators.

PubMed

Mina, George S; Acharya, Madan; Shepherd, Taylor; Gobrial, George; Tekeste, Michael; Watti, Hussam; Bhandari, Ruchi; Saini, Aditya; Reddy, Pratap; Dominic, Paari

2018-03-01

Recently, digoxin use has been found to associate with higher mortality. Yet, potential mechanisms by which digoxin use increases mortality remain unclear. Increased arrhythmogenicity from digoxin use is one possibility. Thus, we aimed to evaluate the relation between digoxin and shock events in patients with implantable cardioverter defibrillators (ICDs). We performed a retrospective chart review of all patients with ICDs and at least 1 device interrogation at our institution between January 1, 2012, and January 1, 2015. We aimed to cover 1 year of interrogation period. Patients with heart failure, atrial fibrillation, or both were included in the analysis. Patients were divided into 2 groups based on digoxin use, defined as use of digoxin for any period of time during ICD interrogation period. Incidence of ICD shock events and electrical storms and hospitalizations were compared between the 2 groups. The study included 202 patients. Of those, 55 patients were on digoxin and 147 were not on digoxin. Patients on digoxin were more likely to receive ICD shocks (odds ratio [OR] = 2.5, 95% confidence interval [95% CI] = 1.01-6.18, P = .04) and have increased risk of electrical storms ( P = .02). Moreover, total hospitalizations were higher in digoxin users ( P = .02). Multivariate logistic regression analysis also showed that digoxin use was an independent predictor of shock events (OR = 4.07, 95% CI = 1.43-11.58, P = .009). Digoxin is associated with increased shock events and electrical storms in patients with ICDs; however, large randomized controlled studies are needed to confirm our findings.

Do implantable cardioverter defibrillators improve survival in patients with severe left ventricular systolic dysfunction after coronary artery bypass graft surgery?

PubMed

Fazal, Iftikhar A; Bates, Matthew G D; Matthews, Iain G; Turley, Andrew J

2011-06-01

A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was whether implantable cardioverter defibrillators (ICD) improve survival in patients with severe left ventricular systolic dysfunction (LVSD) after coronary artery bypass graft (CABG) surgery. ICDs are designed to terminate potentially fatal cardiac tachyarrhythmias. A right ventricular lead is mandatory for detection, pacing and defibrillation capabilities. Dual chamber ICDs have an additional right atrial lead and are used for patients with conventional atrioventricular pacing indications. More sophisticated, biventricular devices exist to provide cardiac resynchronisation therapy (CRT) in addition to defibrillation (CRT-D). ICDs have been extensively investigated in patients with LVSD post myocardial infarction and in patients with non-ischaemic cardiomyopathy for both secondary prevention (history of ventricular arrhythmias) and primary prevention (deemed high risk for ventricular arrhythmias). This best evidence topic aims to review the evidence and its applicability to patients post CABG. Nine hundred and sixteen papers were identified using the search method outlined. Eight randomised controlled trials, two meta-analyses, and one non-randomised trial, in addition to international guidelines presented the best evidence to answer the clinical question. The current evidence base and guidelines suggest that ICDs should be considered for all patients with LVSD [ejection fraction (EF) ≤30-40%] receiving optimal pharmacological management, who are ≥40 days post MI [four weeks for National Institute for Health and Clinical Excellence (NICE)] and in New York Heart Association (NYHA) class I-III. UK NICE guidelines require in addition; non-sustained ventricular tachycardia (NSVT) on a Holter monitor and inducible ventricular tachycardia at electrophysiological study for EF between 30 and 35%; or a QRS >120 ms if EF <30%. The North American guidelines

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.

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

Automated implantable cardioverter defibrillator lead infection in a patient with previous superior vena cava thrombosis.

PubMed

Connelly, Tara; Siddiqui, Sadiq; Kolcow, Walenty; Veerasingam, Dave

2015-11-04

We present a case of a 44-year-old woman who presented with cough, pleuritic chest pain and fever leading to a diagnosis of pneumonia±pulmonary embolism. She had a history of familial hypertrophic obstructive cardiomyopathy (HOCM), for which an automated implantable cardioverter defibrillator (AICD) had been implanted, and a subsequent superior vena cava (SVC) thrombus, for which she was anticoagulated with warfarin. On admission, blood cultures grew a coagulase-negative Staphylococcus. CT pulmonary angiogram and transoesophageal echocardiography (TOE) were performed and revealed large vegetations adherent to the AICD leads with complete occlusion of the SVC. The infected leads were the source of sepsis. Open surgery was planned. For cardiopulmonary bypass, the venous cannula was inserted in the inferior vena cava (IVC) and a completely bloodless field was obtained in the right atrium allowing for the extraction of the AICD leads completely, along with the adherent vegetations from within. 2015 BMJ Publishing Group Ltd.

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

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.

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.

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

PubMed Central

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

2013-01-01

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

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

Depression, psychological distress, and quality of life in patients with cardioverter defibrillator with or without cardiac resynchronization therapy.

PubMed

Knackstedt, Christian; Arndt, Marlies; Mischke, Karl; Marx, Nikolaus; Nieman, Fred; Kunert, Hanns Jürgen; Schauerte, Patrick; Norra, Christine

2014-05-01

Congestive heart failure is frequent and leads to reduced exercise capacity, reduced quality of life (QoL), and depression in many patients. Cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillators (ICD) offer therapeutic options and may have an impact on QoL and depression. This study was performed to evaluate physical and mental health in patients undergoing ICD or combined CRT/ICD-implantation (CRT-D). Echocardiography, spiroergometry, and psychometric questionnaires [Beck Depression Inventory, General World Health Organization Five Well-being Index (WHO-5), Brief Symptom Inventory and 36-item Short Form (SF-36)] were obtained in 39 patients (ICD: 17, CRT-D: 22) at baseline and 6-month follow-up (FU) after device implantation. CRT-D patients had a higher NYHA class and broader left bundle branch block than ICD patients at baseline. At FU, ejection fraction (EF), peak oxygen uptake, and NYHA class improved significantly in CRT-D patients but remained unchanged in ICD patients. Patients with CRT-D implantation showed higher levels of depressive symptoms, psychological distress, and impairment in QoL at baseline and FU compared to ICD patients. These impairments remained mostly unchanged in all patients after 6 months. Overall, these findings imply that there is a need for careful assessment and treatment of psychological distress and depression in ICD and CRT-D patients in the course of device implantation as psychological burden seems to persist irrespective of physical improvement.

Surface electromyography of myopotential oversensing provoked by simultaneous straining and leftward twisting in a patient with an implantable cardioverter defibrillator.

PubMed

Ajiro, Yoichi; Shiga, Tsuyoshi; Shoda, Morio; Hagiwara, Nobuhisa

2017-03-01

An important step in diagnosing myopotential oversensing is to confirm its reproducibility using specific provocation maneuvers. Although most maneuvers involve the co-contraction of many muscles, no attempt has been made to assess relevant muscle activities by electromyography. We describe a case with an implantable cardioverter defibrillator (ICD) whose myopotential oversensing was provoked by simultaneous straining and leftward twisting. Simultaneous recordings from real-time ICD telemetry and myopotentials of the rectus abdominis, oblique abdominis, and diaphragm on electromyography during the provocation maneuvers were conducted. It was shown that all three muscles contracted simultaneously during the provocation maneuvers; the diaphragm activity was the main source of noise oversensing, and the twist itself caused oversensing possibly due to the change in the position of the lead. In conclusion, the electromyographic assessment of relevant muscle activities may be useful in assessing each muscle's role and its contribution to myopotential oversensing, especially in a patient whose myopotential oversensing requires complex maneuvers to be provoked.

Healthcare Utilization and Expenditures Associated With Appropriate and Inappropriate Implantable Defibrillator Shocks.

PubMed

Turakhia, Mintu P; Zweibel, Steven; Swain, Andrea L; Mollenkopf, Sarah A; Reynolds, Matthew R

2017-02-01

In patients with implantable cardioverter-defibrillators, healthcare utilization (HCU) and expenditures related to shocks have not been quantified. We performed a retrospective cohort study of patients with implantable cardioverter-defibrillators identified from commercial and Medicare supplemental claims databases linked to adjudicated shock events from remote monitoring data. A shock event was defined as ≥1 spontaneous shocks delivered by an implanted device. Shock-related HCU was ascertained from inpatient and outpatient claims within 7 days following a shock event. Shock events were adjudicated and classified as inappropriate or appropriate, and HCU and expenditures, stratified by shock type, were quantified. Of 10 266 linked patients, 963 (9.4%) patients (61.3±13.6 years; 81% male) had 1885 shock events (56% appropriate, 38% inappropriate, and 6% indeterminate). Of these events, 867 (46%) had shock-related HCU (14% inpatient and 32% outpatient). After shocks, inpatient cardiovascular procedures were common, including echocardiography (59%), electrophysiology study or ablation (34%), stress testing (16%), and lead revision (11%). Cardiac catheterization was common (71% and 51%), but percutaneous coronary intervention was low (6.5% and 5.0%) after appropriate and inappropriate shocks. Expenditures related to appropriate and inappropriate shocks were not significantly different. After implantable cardioverter-defibrillator shock, related HCU was common, with 1 in 3 shock events followed by outpatient HCU and 1 in 7 followed by hospitalization. Use of invasive cardiovascular procedures was substantial, even after inappropriate shocks, which comprised 38% of all shocks. Implantable cardioverter-defibrillator shocks seem to trigger a cascade of health care. Strategies to reduce shocks could result in cost savings. © 2017 American Heart Association, Inc.

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.

Impact of remote monitoring on reducing the burden of inappropriate shocks related to implantable cardioverter-defibrillator lead fractures: insights from a French single-centre registry.

PubMed

Souissi, Zouheir; Guédon-Moreau, Laurence; Boulé, Stéphane; Kouakam, Claude; Finat, Loïc; Marquié, Christelle; Brigadeau, François; Wissocque, Ludivine; Mouton, Stéphanie; Montaigne, David; Klug, Didier; Kacet, Salem; Lacroix, Dominique

2016-06-01

Lead fractures in implantable cardioverter-defibrillator (ICD) patients may cause inappropriate shocks (ISs). An early diagnosis is essential to prevent adverse clinical events. Implantable cardioverter-defibrillator remote monitoring (RM) permits prompt detection of lead fracture. Limited data define the impact of RM on ISs specifically related to lead fracture. We sought to compare the number of ISs related to lead fracture in patients with vs. without RM follow-up. We checked the registry of our institution and collected, between July 2007 and June 2014, 115 cases of right ventricular lead fractures. All relevant data were documented from patients' files, device-interrogation printouts and electronic records, and remote transmissions databases when applicable. We assessed the ISs that were related to lead fracture. The first study endpoint was the number of ISs per shocked patient. Among the 82 patients with conventional follow-up (CFU) and the 33 patients with RM, a first IS occurred to 32.9% (n = 27) and 30.3% (n = 10, P = 0.83) of the patients, respectively. Shocked patients in the RM group underwent significantly fewer ISs with a mean of 6 ± 2 shocks per patient [median of 3.5 shocks (2-8)] than those in the CFU group with a mean of 18 ± 5 shocks per patient [median of 10 shocks (5-22), P = 0.03]. Remote monitoring helps to reduce the burden of ISs related to ICD lead fractures. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

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.

Antitachycardia pacing programming in implantable cardioverter defibrillator: A systematic review

PubMed Central

De Maria, Elia; Giacopelli, Daniele; Borghi, Ambra; Modonesi, Letizia; Cappelli, Stefano

2017-01-01

Implantable cardioverter defibrillator (ICD) programming involves several parameters. In recent years antitachycardia pacing (ATP) has gained an increasing importance in the treatment of ventricular arrhythmias, whether slow or fast. It reduces the number of unnecessary and inappropriate shocks and improves both patient’s quality of life and device longevity. There is no clear indication regarding the type of ATP to be used, except for the treatment of fast ventricular tachycardias (188 bpm-250 bpm) where it has been shown a greater efficacy and safety of burst compared to ramp; 8 impulses in each sequence of ATP appears to be the best programming option in this setting. Beyond ATP use, excellent clinical results were obtained with programming standardization following these principles: extended detection time in ventricular fibrillation (VF) zone; supraventricular discrimination criteria up to 200 bpm; first shock in VF zone at the maximum energy in order to reduce the risk of multiple shocks. The MADIT-RIT trial and some observational registries have also recently demonstrated that programming with a widespread use of ATP, higher cut-off rates or delayed intervention reduces the number of inappropriate and unnecessary therapies and improves the survival of patients during mid-term follow-up. PMID:28603590

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.

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.

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.

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.

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.

Influence of secondary neutrons induced by proton radiotherapy for cancer patients with implantable cardioverter defibrillators

PubMed Central

2012-01-01

Background Although proton radiotherapy is a promising new approach for cancer patients, functional interference is a concern for patients with implantable cardioverter defibrillators (ICDs). The purpose of this study was to clarify the influence of secondary neutrons induced by proton radiotherapy on ICDs. Methods The experimental set-up simulated proton radiotherapy for a patient with an ICD. Four new ICDs were placed 0.3 cm laterally and 3 cm distally outside the radiation field in order to evaluate the influence of secondary neutrons. The cumulative in-field radiation dose was 107 Gy over 10 sessions of irradiation with a dose rate of 2 Gy/min and a field size of 10 × 10 cm2. After each radiation fraction, interference with the ICD by the therapy was analyzed by an ICD programmer. The dose distributions of secondary neutrons were estimated by Monte-Carlo simulation. Results The frequency of the power-on reset, the most serious soft error where the programmed pacing mode changes temporarily to a safety back-up mode, was 1 per approximately 50 Gy. The total number of soft errors logged in all devices was 29, which was a rate of 1 soft error per approximately 15 Gy. No permanent device malfunctions were detected. The calculated dose of secondary neutrons per 1 Gy proton dose in the phantom was approximately 1.3-8.9 mSv/Gy. Conclusions With the present experimental settings, the probability was approximately 1 power-on reset per 50 Gy, which was below the dose level (60-80 Gy) generally used in proton radiotherapy. Further quantitative analysis in various settings is needed to establish guidelines regarding proton radiotherapy for cancer patients with ICDs. PMID:22284700

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.

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.

The Italian subcutaneous implantable cardioverter-defibrillator survey: S-ICD, why not?

PubMed

Botto, Giovanni Luca; Forleo, Giovanni B; Capucci, Alessandro; Solimene, Francesco; Vado, Antonello; Bertero, Giovanni; Palmisano, Pietro; Pisanò, Ennio; Rapacciuolo, Antonio; Infusino, Tommaso; Vicentini, Alessandro; Viscusi, Miguel; Ferrari, Paola; Talarico, Antonello; Russo, Giovanni; Boriani, Giuseppe; Padeletti, Luigi; Lovecchio, Mariolina; Valsecchi, Sergio; D'Onofrio, Antonio

2017-11-01

A recommendation for a subcutaneous-implantable cardioverter-defibrillator (S-ICD) has been added to recent European Society of Cardiology Guidelines. However, the S-ICD is not ideally suitable for patients who need pacing. The aim of this survey was to analyse the current practice of ICD implantation and to evaluate the actual suitability of S-ICD. The survey 'S-ICD Why Not?' was an independent initiative taken by the Italian Heart Rhythm Society (AIAC). Clinical characteristics, selection criteria, and factors guiding the choice of ICD type were collected in consecutive patients who underwent ICD implantation in 33 Italian centres from September to December 2015. A cardiac resynchronization therapy (CRT) device was implanted in 39% (369 of 947) of patients undergoing de novo ICD implantation. An S-ICD was implanted in 12% of patients with no CRT indication (62 of 510 with available data). S-ICD patients were younger than patients who received transvenous ICD, more often had channelopathies, and more frequently received their device for secondary prevention of sudden death. More frequently, the clinical reason for preferring a transvenous ICD over an S-ICD was the need for pacing (45%) or for antitachycardia pacing (36%). Nonetheless, only 7% of patients fulfilled conditions for recommending permanent pacing, and 4% of patients had a history of monomorphic ventricular tachycardia that might have been treatable with antitachycardia pacing. The vast majority of patients needing ICD therapy are suitable candidates for S-ICD implantation. Nevertheless, it currently seems to be preferentially adopted for secondary prevention of sudden death in young patients with channelopathies. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

Defibrillation threshold testing fails to show clinical benefit during long-term follow-up of patients undergoing cardiac resynchronization therapy defibrillator implantation.

PubMed

Michowitz, Yoav; Lellouche, Nicolas; Contractor, Tahmeed; Bourke, Tara; Wiener, Isaac; Buch, Eric; Boyle, Noel; Bersohn, Malcolm; Shivkumar, Kalyanam

2011-05-01

The utility of defibrillation threshold testing in patients undergoing implantable cardioverter-defibrillator (ICD) implantation is controversial. Higher defibrillation thresholds have been noted in patients undergoing implantation of cardiac resynchronization therapy defibrillators (CRT-D). Since the risks and potential benefits of testing may be higher in this population, we sought to assess the impact of defibrillation safety margin or vulnerability safety margin testing in CRT-D recipients. A total of 256 consecutive subjects who underwent CRT-D implantation between January 2003 and December 2007 were retrospectively reviewed. Subjects were divided into two groups based on whether (n= 204) or not (n= 52) safety margin testing was performed. Patient characteristics, tachyarrhythmia therapies, procedural results, and clinical outcomes were recorded. Baseline characteristics, including heart failure (HF) severity, were comparable between the groups. Four cases of HF exacerbation (2%), including one leading to one death, were recorded in the tested group immediately post-implantation. No complications were observed in the untested group. After a mean follow-up of 32 ± 20 months, the proportion of appropriate shocks in the two groups was similar (31 vs. 25%, P = 0.49). There were three cases of failed appropriate shocks in the tested group, despite adequate safety margins at implantation, whereas no failed shocks were noted in the untested group. Survival was similar in the two groups. Defibrillation efficacy testing during implant of CRT-D was associated with increased morbidity and did not predict the success of future device therapy or improve survival during long-term follow-up.

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.

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.

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.

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.

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.

Time until diagnosis of clinical events with different remote monitoring systems in Implantable Cardioverter-Defibrillator patients.

PubMed

Söth-Hansen, Malene; Witt, Christoffer Tobias; Rasmussen, Mathis; Kristensen, Jens; Gerdes, Christian; Nielsen, Jens Cosedis

2018-05-24

Remote monitoring (RM) is an established technology integrated into routine follow-up of patients with implantable cardioverter-defibrillator (ICD). Current RM systems differ according to transmission frequency and alert definition. We aimed to compare time difference between detection and acknowledgement of clinically relevant events between four RM systems. We analyzed time delay between detection of ventricular arrhythmic and technical events by the ICD and acknowledgement by hospital staff in 1.802 consecutive patients followed with RM during September 2014 - August 2016. Devices from Biotronik (BIO, n=374), Boston Scientific (BSC, n=196), Medtronic (MDT, n=468) and St Jude Medical (SJM, n=764) were included. We identified all events from RM webpages and their acknowledgement with RM or at in-clinic follow-up. Events occurring during weekends were excluded. We included 3.472 events. Proportion of events acknowledged within 24 hours was 72%, 23%, 18% and 65% with BIO, BSC, MDT and SJM, respectively, with median times of 13, 222, 163 and 18 hours from detection to acknowledgement (p<0.001 for both comparisons between manufacturers). Including only events transmitted as alerts by RM, 72%, 68%, 61% and 65% for BIO, BSC, MDT and SJM, respectively were acknowledged within 24 hours. Variation in time to acknowledgement of ventricular tachyarrhythmia episodes not treated with shock therapy was the primary cause for the difference between manufacturers. Significant and clinically relevant differences in time delay from event detection to acknowledgement exist between RM systems. Varying definitions of which events RM transmits as alerts are important for the differences observed. Copyright © 2018. Published by Elsevier Inc.

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.

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.

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.

A review of economic evaluation models for cardiac resynchronization therapy with implantable cardioverter defibrillators in patients with heart failure.

PubMed

Tomini, F; Prinzen, F; van Asselt, A D I

2016-12-01

Cardiac resynchronization therapy with a biventricular pacemaker (CRT-P) is an effective treatment for dyssynchronous heart failure (DHF). Adding an implantable cardioverter defibrillator (CRT-D) may further reduce the risk of sudden cardiac death (SCD). However, if the majority of patients do not require shock therapy, the cost-effectiveness ratio of CRT-D compared to CRT-P may be high. The objective of this study was to systematically review decision models evaluating the cost-effectiveness of CRT-D for patients with DHF, compare the structure and inputs of these models and identify the main factors influencing the ICERs for CRT-D. A comprehensive search strategy of Medline (Ovid), Embase (Ovid) and EconLit identified eight cost-effectiveness models evaluating CRT-D against optimal pharmacological therapy (OPT) and/or CRT-P. The selected economic studies differed in terms of model structure, treatment path, time horizons, and sources of efficacy data. CRT-D was found cost-effective when compared to OPT but its cost-effectiveness became questionable when compared to CRT-P. Cost-effectiveness of CRT-D may increase depending on improvement of all-cause mortality rates and HF mortality rates in patients who receive CRT-D, costs of the device, and battery life. In particular, future studies need to investigate longer-term mortality rates and identify CRT-P patients that will gain the most, in terms of life expectancy, from being treated with a CRT-D.

Dual chamber arrhythmia detection in the implantable cardioverter defibrillator.

PubMed

Dijkman, B; Wellens, H J

2000-10-01

Dual chamber implantable cardioverter defibrillator (ICD) technology extended ICD therapy to more than termination of hemodynamically unstable ventricular tachyarrhythmias. It created the basis for dual chamber arrhythmia management in which dependable detection is important for treatment and prevention of both ventricular and atrial arrhythmias. Dual chamber detection algorithms were investigated in two Medtronic dual chamber ICDs: the 7250 Jewel AF (33 patients) and the 7271 Gem DR (31 patients). Both ICDs use the same PR Logic algorithm to interpret tachycardia as ventricular tachycardia (VT), supraventricular tachycardia (SVT), or dual (VT+ SVT). The accuracy of dual chamber detection was studied in 310 of 1,367 spontaneously occurring tachycardias in which rate criterion only was not sufficient for arrhythmia diagnosis. In 78 episodes there was a double tachycardia, in 223 episodes SVT was detected in the VT or ventricular fibrillation zone, and in 9 episodes arrhythmia was detected outside the boundaries of the PR Logic functioning. In 100% of double tachycardias the VT was correctly diagnosed and received priority treatment. SVT was seen in 59 (19%) episodes diagnosed as VT. The causes of inappropriate detection were (1) algorithm failure (inability to fulfill the PR

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.

"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

Shock Reduction With Antitachycardia Pacing Before and During Charging for Fast Ventricular Tachycardias in Patients With Implantable Defibrillators.

PubMed

Dallaglio, Paolo Domenico; Anguera, Ignasi; Martínez Ferrer, José B; Pérez, Luisa; Viñolas, Xavier; Porres, Jose Manuel; Fontenla, Adolfo; Alzueta, Javier; Martínez, Juan Gabriel; Rodríguez, Aníbal; Basterra, Nuria; Sabaté, Xavier

2017-12-11

Fast ventricular tachycardias in the ventricular fibrillation zone in patients with an implantable cardioverter-defibrillator are susceptible to antitachycardia pacing (ATP) termination. Some manufacturers allow programming 2 ATP bursts: before charging (BC) and during (DC) charging. The aim of this study was to describe the safety and effectiveness of ATP BC and DC for fast ventricular tachycardias in the ventricular fibrillation zone in patients with an implantable cardioverter-defibrillator in daily clinical practice. Data proceeded from the multicenter UMBRELLA trial, including implantable cardioverter-defibrillator patients followed up by the CareLink monitoring system. Fast ventricular tachycardias in the ventricular fibrillation zone until a cycle length of 200ms with ATP BC and/or ATP DC were included. We reviewed 542 episodes in 240 patients. Two ATP bursts (BC/DC) were programmed in 291 episodes (53.7%, 87 patients), while 251 episodes (46.3%, 153 patients) had 1 ATP burst only DC. The number of episodes terminated by 1 ATP DC was 139, representing 55.4% effectiveness (generalized estimating equation-adjusted 60.4%). There were 256 episodes terminated by 1 or 2 ATP (BC/DC), representing 88% effectiveness (generalized estimating equation-adjusted 79.3%); the OR for ATP effectiveness BC/DC vs DC was 2.5, 95%CI, 1.5-4.1; P <.001. Shocked episodes were 112 (45%) for ATP DC vs 35 (12%) for ATP BC/DC, representing an absolute reduction of 73%. The mean shocked episode duration was 16seconds for ATP DC vs 19seconds for ATP BC/DC (P=.07). The ATP DC in the ventricular fibrillation zone for fast ventricular tachycardia is moderately effective. Adding an ATP burst BC increases the overall effectiveness, reduces the need for shocks, and does not prolong episode duration. Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

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.

Primary Prevention of Sudden Cardiac Death in Adults with Transposition of the Great Arteries: A Review of Implantable Cardioverter-Defibrillator Placement

PubMed Central

Cedars, Ari M.

2015-01-01

Transposition of the great arteries encompasses a set of structural congenital cardiac lesions that has in common ventriculoarterial discordance. Primarily because of advances in medical and surgical care, an increasing number of children born with this anomaly are surviving into adulthood. Depending upon the subtype of lesion or the particular corrective surgery that the patient might have undergone, this group of adult congenital heart disease patients constitutes a relatively new population with unique medical sequelae. Among the more common and difficult to manage are cardiac arrhythmias and other sequelae that can lead to sudden cardiac death. To date, the question of whether implantable cardioverter-defibrillators should be placed in this cohort as a preventive measure to abort sudden death has largely gone unanswered. Therefore, we review the available literature surrounding this issue. PMID:26413012

Impact of new X-ray technology on patient dose in pacemaker and implantable cardioverter defibrillator (ICD) implantations.

PubMed

van Dijk, Joris D; Ottervanger, Jan Paul; Delnoy, Peter Paul H M; Lagerweij, Martine C M; Knollema, Siert; Slump, Cornelis H; Jager, Pieter L

2017-01-01

New X-ray technology providing new image processing techniques may reduce radiation exposure. The aim of this study was to quantify this radiation exposure reduction for patients during pacemaker and implantable cardioverter defibrillator (ICD) implantation. In this retrospective study, 1185 consecutive patients who had undergone de novo pacemaker or ICD implantation during a 2-year period were included. All implantations in the first year were performed using the reference technology (Allura Xper), whereas in the second year, the new X-ray technology (AlluraClarity) was used. Radiation exposure, expressed as the dose area product (DAP), was compared between the two time periods to determine the radiation exposure reduction for pacemaker and ICD implantations without cardiac resynchronization therapy (CRT) and with CRT. Procedure duration and contrast volume were used as measures to compare complexity and image quality. The study population consisted of 591 patients who had undergone an implantation using the reference technology, and 594 patients with the new X-ray technology. The two groups did not differ in age, gender, or body mass index. The DAP decreased with 69 % from 16.4 ± 18.5 to 5.2 ± 6.6 Gy cm 2 for the non-CRT implantations (p < 0.001). The DAP decreased with 75 % from 72.1 ± 60.0 to 17.8 ± 17.4 Gy cm 2 for the CRT implantations (p < 0.001). Nevertheless, procedure duration and contrast volume did not differ when using the new technology (p = 0.09 and p = 0.20, respectively). Introduction of new X-ray technology resulted in a radiation exposure reduction of more than 69 % for patients during pacemaker and ICD implantation while image quality was unaffected.

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

Use of the wearable cardioverter-defibrillator (WCD) and WCD-based remote rhythm monitoring in a real-life patient cohort.

PubMed

Zylla, Maura M; Hillmann, Henrike A K; Proctor, Tanja; Kieser, Meinhard; Scholz, Eberhard; Zitron, Edgar; Katus, Hugo A; Thomas, Dierk

2018-05-02

The wearable cardioverter-defibrillator (WCD) was introduced to provide protection from sudden cardiac death (SCD) in patients with transiently elevated risk or during ongoing risk stratification. Benefits and clinical characteristics of routine WCD use remain to be assessed in larger patient populations. This study aims to identify determinants of WCD compliance, therapies, and inappropriate alarms in a real-life cohort. A total of 106 cases (68.9% male) were included between 11/2010 and 04/2016. WCD therapies, automatically recorded arrhythmia episodes, inappropriate WCD alarms, patient compliance, and outcome after WCD prescription were analyzed. Median duration of WCD use was 58.5 days. Average daily wearing time was 22.7 h. Compliance was reduced in patients ≤ 50 years. Three patients received WCD therapies (2.8%). In one case ventricular fibrillation (VF) was appropriately terminated with the first shock. Two patients received inappropriate WCD therapies due to WCD algorithm activation during ventricular pacemaker stimulation. One patient died of asystole while carrying a WCD (0.9%). Additional arrhythmias detected comprised self-terminating sustained ventricular tachycardia (VT; 2.8%), non-sustained VT (2.8%), and supraventricular arrhythmias (5.7%). Inappropriate WCD alarms due to over-/undersensing occurred in 77/106 patients (72.6%), of which 41 (38.7%) experienced ≥ 10 inappropriate WCD alarms during the prescription period. Thirteen patients (12.3%) displayed a mean of > 1 inappropriate alarms/day. WCD use was associated with high compliance and provided protection from VT/VF-related SCD. The majority of patients experienced inappropriate WCD alarms. Alterations in QRS morphology during pacemaker stimulation require consideration in WCD programming to prevent inappropriate alarms.

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

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

PubMed

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

2015-09-01

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

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.

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.

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.

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.

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

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

PubMed

Walsh, Edward P; Cecchin, Frank

2004-03-01

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

Influence of renal function on mortality and ventricular arrhythmias in patients undergoing first implantable cardioverter-defibrillator generator replacement.

PubMed

Waks, Jonathan W; Higgins, Angela Y; Mittleman, Murray A; Buxton, Alfred E

2015-03-01

Impaired renal function is associated with increased mortality among patients with implantable cardioverter-defibrillators (ICDs). The relationship between renal function at time of ICD generator replacement and subsequent appropriate ICD therapies is not known. We identified 441 patients who underwent first ICD generator replacement between 2000 and 2011 and had serum creatinine measured within 30 days of their procedure. Patients were divided into tertiles based on estimated glomerular filtration rate (eGFR). Adjusted Cox proportional hazard and competing risk models were used to assess relationships between eGFR and subsequent mortality and appropriate ICD therapy. Median eGFR was 37.6, 59.3, and 84.8 mL/min/1.73 m(2) for tertiles 1-3, respectively. Five-year Kaplan-Meier survival probability was 34.8%, 61.4%, and 84.5% for tertiles 1-3, respectively (P < 0.001). After multivariable adjustment, compared to tertile 3, worse eGFR tertile was associated with increased mortality (HR 2.84, 95% CI [1.36-5.94] for tertile 2; HR 3.84, 95% CI [1.81-8.12] for tertile 1). At 5 years, 57.0%, 58.1%, and 60.2% of patients remained free of appropriate ICD therapy in tertiles 1-3, respectively (P = 0.82). After adjustment, eGFR tertile was not associated with future appropriate ICD therapy. Results were unchanged in an adjusted competing risk model accounting for death. At time of first ICD generator replacement, lower eGFR is associated with higher mortality, but not with appropriate ICD therapies. The poorer survival of ICD patients with reduced eGFR does not appear to be influenced by arrhythmia status, and there is no clear proarrhythmic effect of renal dysfunction, even after accounting for the competing risk of death. © 2014 Wiley Periodicals, Inc.

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.

Survival after shock therapy in implantable cardioverter-defibrillator and cardiac resynchronization therapy-defibrillator recipients according to rhythm shocked. The ALTITUDE survival by rhythm study.

PubMed

Powell, Brian D; Saxon, Leslie A; Boehmer, John P; Day, John D; Gilliam, F Roosevelt; Heidenreich, Paul A; Jones, Paul W; Rousseau, Matthew J; Hayes, David L

2013-10-29

This study sought to determine if the risk of mortality associated with inappropriate implantable cardioverter-defibrillator (ICD) shocks is due to the underlying arrhythmia or the shock itself. Shocks delivered from ICDs are associated with an increased risk of mortality. It is unknown if all patients who experience inappropriate ICD shocks have an increased risk of death. We evaluated survival outcomes in patients with an ICD and a cardiac resynchronization therapy defibrillator enrolled in the LATITUDE remote monitoring system (Boston Scientific Corp., Natick, Massachusetts) through January 1, 2010. First shock episode rhythms from 3,809 patients who acutely survived the initial shock were adjudicated by 7 electrophysiologists. Patients with a shock were matched to patients without a shock (n = 3,630) by age at implant, implant year, sex, and device type. The mean age of the study group was 64 ± 13 years, and 78% were male. Compared with no shock, there was an increased rate of mortality in those who received their first shock for monomorphic ventricular tachycardia (hazard ratio [HR]: 1.65, p < 0.0001), ventricular fibrillation/polymorphic ventricular tachycardia (HR: 2.10, p < 0.0001), and atrial fibrillation/flutter (HR: 1.61, p = 0.003). In contrast, mortality after first shocks due to sinus tachycardia and supraventricular tachycardia (HR: 0.97, p = 0.86) and noise/artifact/oversensing (HR: 0.91, p = 0.76) was comparable to that in patients without a shock. Compared with no shock, those who received their first shock for ventricular rhythms and atrial fibrillation had an increased risk of death. There was no significant difference in survival after inappropriate shocks for sinus tachycardia or noise/artifact/oversensing. In this study, the adverse prognosis after first shock appears to be more related to the underlying arrhythmia than to an adverse effect from the shock itself. Copyright © 2013 American College of Cardiology Foundation. Published by

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.

Survival in Women Versus Men Following Implantation of Pacemakers, Defibrillators, and Cardiac Resynchronization Therapy Devices in a Large, Nationwide Cohort.

PubMed

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

2017-05-10

Whether outcomes differ between sexes following treatment with pacemakers (PM), implantable cardioverter defibrillators, and cardiac resynchronization therapy (CRT) devices is unclear. Consecutive US patients with newly implanted PM, implantable cardioverter defibrillators, and CRT devices from a large remote monitoring database between 2008 and 2011 were included in this observational cohort study. Sex-specific all-cause survival postimplant was compared within each device type using a multivariable Cox proportional hazards model, stratified on age and adjusted for remote monitoring utilization and ZIP-based socioeconomic variables. A total of 269 471 patients were assessed over a median 2.9 [interquartile range, 2.2, 3.6] years. Unadjusted mortality rates (MR; deaths/100 000 patient-years) were similar between women versus men receiving PMs (n=115 076, 55% male; MR 4193 versus MR 4256, respectively; adjusted hazard ratio, 0.87; 95% CI, 0.84-0.90; P <0.001) and implantable cardioverter defibrillators (n=85 014, 74% male; MR 4417 versus MR 4479, respectively; adjusted hazard ratio, 0.98; 95% CI, 0.93-1.02; P =0.244). In contrast, survival was superior in women receiving CRT defibrillators (n=61 475, 72% male; MR 5270 versus male MR 7175; adjusted hazard ratio, 0.73; 95% CI, 0.70-0.76; P <0.001) and also CRT pacemakers (n=7906, 57% male; MR 5383 versus male MR 7625, adjusted hazard ratio, 0.69; 95% CI, 0.61-0.78; P <0.001). This relative difference increased with time. These results were unaffected by age or remote monitoring utilization. Women accounted for less than 30% of high-voltage implants and fewer than half of low-voltage implants in a large, nation-wide cohort. Survival for women and men receiving implantable cardioverter defibrillators and PMs was similar, but dramatically greater for women receiving both defibrillator- and PM-based CRT. © 2017 The Authors and St. Jude Medical. Published on behalf of the American Heart Association, Inc., by Wiley.

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.

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

Psychosocial impact of implantable cardioverter defibrillators (ICD) in young adults with Tetralogy of Fallot.

PubMed

Opić, Petra; Utens, Elisabeth M W J; Moons, Philip; Theuns, Dominic A M J; van Dijk, Arie P J; Hoendermis, Elke S; Vliegen, Hubert W; de Groot, Natasja M S; Witsenburg, Maarten; Schalij, Martin; Roos-Hesselink, Jolien W

2012-07-01

To investigate the psychosocial impact of having an implantable cardioverter defibrillator (ICD) in adults with Tetralogy of Fallot (ToF). Included were 26 ToF-patients with an ICD (age 44 ± 12 years), and two control groups consisting of 28 ToF-patients without an ICD (age 40 ± 10 years) and a group of 35 ICD-patients of older age without ToF (age 72.0 ± 8 years). This last control group was chosen to represent the "older general ICD population" with acquired heart disease seen at the out-patient clinic. Psychosocial functioning encompassed daily functioning, subjective health status, quality of life, anxiety, depression, coping and social support. ToF-patients with ICD showed diminished psychosocial functioning in comparison to ToF-patients without ICD. This was reflected by diminished subjectively perceived physical functioning (p = 0.01), general health perception (p < 0.01) and a lower satisfaction with life (p = 0.02). In comparison to older ICD-patients, ToF-patients with ICD showed less satisfaction with life (p = 0.03), experienced more anxiety (p = 0.01) and showed less favourable coping styles, although physical functioning was better for ToF-patients with ICD than for older ICD-patients (p = 0.01). More inappropriate shocks were found in ToF-patients with ICD compared to the older ICD-patients. In patients with ToF, ICD implantation had a major impact on psychosocial functioning which should be taken into account when considering ICD implantation in these young patients. To help improve psychosocial functioning, psychological counselling attuned to the specific needs of these patients may be useful.

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

Diagnosis and therapy of atrial tachyarrhythmias in the dual chamber implantable cardioverter defibrillator.

PubMed

Dijkman, B; Wellens, H J

2000-11-01

Devices capable of monitoring and treating atrial tachyarrhythmias provide information about the natural history of the arrhythmias and potentially can influence their natural course by electrical therapy early after onset. Types of atrial arrhythmias and efficacy of device therapies were evaluated in 30 patients implanted with the Medtronic model 7250 Jewel AF implantable cardioverter defibrillator (ICD). All patients had structural heart disease and documented sustained ventricular and atrial arrhythmias (27 with atrial fibrillation [AF]) before implant. Twenty patients were taking amiodarone, and three were taking sotalol. During 20+/-10 months of follow-up, 600 atrial arrhythmia recurrences were documented in 50% of patients. AF was diagnosed in 19%, fast polymorphic atrial tachycardia (AT) in 20%, fast monomorphic AT in 57%, and slow AT in 4% of episodes. The two adaptive pacing therapies, burst and ramp, together with the 50-Hz burst, were successful in 57% of detected atrial arrhythmias. Burst and ramp were responsible for 49% and 50-Hz burst for 51% of successfully treated arrhythmias; 33% of the episodes terminated spontaneously. No ventricular proarrhythmia was observed due to atrial pacing therapies. In 30% of episodes, dual chamber pacing was required due to post termination bradycardia. Atrial arrhythmia recurrences in patients with dilated cardiomyopathy were not amenable to pacing therapies. Several aspects of atrial arrhythmia diagnosis, therapy, and documentation that are specific for functioning of the Jewel AF are discussed. Atrial arrhythmias in ICD patients with diseased hearts who are taking Class III antiarrhythmics frequently had longer cycle lengths than AF. Half of these arrhythmias could be terminated with pacing therapies; one third terminated spontaneously.

Single-Coil Defibrillator Leads Yield Satisfactory Defibrillation Safety Margin in Hypertrophic Cardiomyopathy.

PubMed

Okamura, Hideo; Friedman, Paul A; Inoue, Yuko; Noda, Takashi; Aiba, Takeshi; Yasuda, Satoshi; Ogawa, Hisao; Kamakura, Shiro; Kusano, Kengo; Espinosa, Raul E

2016-09-23

Single-coil defibrillator leads have gained favor because of their potential ease of extraction. However, a high defibrillation threshold remains a concern in patients with hypertrophic cardiomyopathy (HCM), and in many cases, dual-coil leads have been used for this patient group. There is little data on using single-coil leads for HCM patients. We evaluated 20 patients with HCM who received an implantable cardioverter-defibrillator (ICD) on the left side in combination with a dual-coil lead. Two sets of defibrillation tests were performed in each patient, one with the superior vena cava (SVC) coil "on" and one with the SVC coil "off". ICDs were programmed to deliver 25 joules (J) for the first attempt followed by maximum energy (35 J or 40 J). Shock impedance and shock pulse width at 25 J in each setting as well as the results of the shock were analyzed. All 25-J shocks in both settings successfully terminated ventricular fibrillation. However, shock impedance and pulse width increased substantially with the SVC coil programmed "off" compared with "on" (66.4±6.1 ohm and 14.0±1.3 ms "off" vs. 41.9±5.0 ohm and 9.3±0.8 ms "on", P<0.0001 respectively). Biphasic 25-J shocks with the SVC coil 'off' successfully terminated ventricular fibrillation in HCM patients, indicating a satisfactory safety margin for 35-J devices. Single-coil leads appear appropriate for left-sided implantation in this patient group. (Circ J 2016; 80: 2199-2203).

Survival of Patients Receiving a Primary Prevention Implantable Cardioverter-Defibrillator in Clinical Practice vs Clinical Trials

PubMed Central

Al-Khatib, Sana M.; Hellkamp, Anne; Bardy, Gust H.; Hammill, Stephen; Jackson Hall, W.; Mark, Daniel B.; Anstrom, Kevin J.; Curtis, Jeptha; Al-Khalidi, Hussein; Curtis, Lesley H.; Heidenreich, Paul; Peterson, Eric D.; Sanders, Gillian; Clapp-Channing, Nancy; Lee, Kerry L.; Moss, Arthur J.

2013-01-01

Importance Randomized clinical trials have shown that implantable cardioverter-defibrillator (ICD) therapy saves lives. Whether the survival of patients who received an ICD in primary prevention clinical trials differs from that of trial-eligible patients receiving a primary prevention ICD in clinical practice is unknown. Objective To determine whether trial-eligible patients who received a primary prevention ICD as documented in a large national registry have a survival rate that differs from the survival rate of similar patients who received an ICD in the 2 largest primary prevention clinical trials, MADIT-II (n=742) and SCD-HeFT (n=829). Design, Setting, and Patients Retrospective analysis of data for patients enrolled in the National Cardiovascular Data Registry ICD Registry between January 1, 2006, and December 31, 2007, meeting the MADIT-II criteria (2464 propensity score–matched patients) or the SCD-HeFT criteria (3352 propensity score–matched patients). Mortality data for the registry patients were collected through December 31, 2009. Main Outcome Measures Cox proportional hazards models were used to compare mortality from any cause. Results The median follow-up time in MADIT-II, SCD-HeFT, and the ICD Registry was 19.5, 46.1, and 35.2 months, respectively. Compared with patients enrolled in the clinical trials, patients in the ICD Registry were significantly older and had a higher burden of comorbidities. In the matched cohorts, there was no significant difference in survival between MADIT-II–like patients in the registry and MADIT-II patients randomized to receive an ICD (2-year mortality rates: 13.9% and 15.6%, respectively; adjusted ICD Registry vs trial hazard ratio, 1.06; 95% CI, 0.85–1.31; P=.62). Likewise, the survival among SCD-HeFT–like patients in the registry was not significantly different from survival among patients randomized to receive ICD therapy in SCD-HeFT (3-year mortality rates: 17.3% and 17.4%, respectively; adjusted registry

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.

Optimizing implantable cardioverter-defibrillator treatment of rapid ventricular tachycardia: antitachycardia pacing therapy during charging.

PubMed

Schoels, Wolfgang; Steinhaus, David; Johnson, W Ben; O'hara, Gilles; Schwab, Joerg O; Jenniskens, Inge; Degroot, Paul J; Tang, Feng; Helmling, Erhard

2007-07-01

Previous studies in implantable cardioverter-defibrillator (ICD) patients demonstrated the efficacy and safety of antitachycardia pacing (ATP) for rapid ventricular tachycardias (VT). To prevent shock delay in case of ATP failure, a new feature (ATP during charging) was developed to deliver ATP for rapid VT while charging for shock. The purpose of this study was to determine the efficacy and safety of this new feature. In a prospective, nonrandomized trial, patients with standard ICD indication received an EnTrust ICD. VT and ventricular fibrillation (VF) episodes were reviewed for appropriate detection, ATP success, rhythm acceleration, and related symptoms. In 421 implanted patients, 116 VF episodes occurred in 37 patients. Eighty-four (72%) episodes received ATP during or before charging. ATP prevented a shock in 58 (69%) of 84 episodes in 15 patients. ATP stopped significantly more monomorphic (77%) than polymorphic VTs (44%, P = .05). Five (6%) episodes accelerated after ATP but were terminated by the backup shock(s). No symptoms were related to ATP during charging. In four patients, 38 charges were saved by delivering ATP before charging. Of 98 induced VF episodes, 28% were successfully terminated by ATP versus 69% for spontaneous episodes (P <.01). Most VTs detected in the VF zone can be painlessly terminated by ATP delivered during charging, with a low risk of acceleration or symptoms. ATP before charging allows delivery of two ATP attempts before shock in the same time that would otherwise be required to deliver only one ATP plus a shock. It also offers potential battery energy savings.

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.

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

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.

Effects of implantable cardioverter/defibrillator shock and antitachycardia pacing on anxiety and quality of life: A MADIT-RIT substudy.

PubMed

Perini, Alessandro Paoletti; Kutyifa, Valentina; Veazie, Peter; Daubert, James P; Schuger, Claudio; Zareba, Wojciech; McNitt, Scott; Rosero, Spencer; Tompkins, Christine; Padeletti, Luigi; Moss, Arthur J

2017-07-01

Effects of implantable cardioverter/defibrillator (ICD) shocks and antitachycardia pacing (ATP) on anxiety and quality of life (QoL) in ICD patients are poorly understood. We evaluated changes in QoL from baseline to 9-month follow-up using the EQ-5D questionnaire in patients enrolled in the Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT) (n=1,268). We assessed anxiety levels using the Florida Shock Anxiety Scale (1-10 score) in patients with appropriate or inappropriate shocks or ATP compared to those with no ICD therapy during the first 9 months postimplant. The analysis was stratified by number of ATP or shocks (0-1 vs ≥2) and adjusted for covariates. In MADIT-RIT, 15 patients (1%) had ≥2 appropriate shocks, 38 (3%) had ≥2 appropriate ATPs. Two or more inappropriate shocks were delivered in 16 patients (1%); ≥2 inappropriate ATPs, in 70. In multivariable analysis, patients with ≥2 appropriate shocks had higher levels of shock-related anxiety than those with ≤1 appropriate shock (P<.01). Furthermore, ≥2 inappropriate shocks produced more anxiety than ≤1 inappropriate shock (P=.005). Consistently, ≥2 appropriate ATPs resulted in more anxiety than ≤1 (P=.028), whereas the number of inappropriate ATPs showed no association with anxiety levels (P=.997). However, there was no association between QoL and appropriate or inappropriate ATP/shock (all P values > .05). In MADIT-RIT, ≥2 appropriate or inappropriate ICD shocks and ≥2 appropriate ATPs are associated with more anxiety at 9-month follow-up despite no significant changes in the assessment of global QoL by the EQ-5D questionnaire. Innovative ICD programming reducing inappropriate therapies may help deal with patient concerns about the device. Copyright © 2017 Elsevier Inc. All rights reserved.

Implantable Cardioverter-defibrillator Therapy for Hypertrophic Cardiomyopathy: Usefulness in Primary and Secondary Prevention.

PubMed

Sarrias, Axel; Galve, Enrique; Sabaté, Xavier; Moya, Àngel; Anguera, Ignacio; Núñez, Elaine; Villuendas, Roger; Alcalde, Óscar; García-Dorado, David

2015-06-01

Hypertrophic cardiomyopathy is a frequent cause of sudden death. Clinical practice guidelines indicate defibrillator implantation for primary prevention in patients with 1 or more risk factors and for secondary prevention in patients with a history of aborted sudden death or sustained ventricular arrhythmias. The aim of the present study was to analyze the follow-up of patients who received an implantable defibrillator following the current guidelines in nonreferral centers for this disease. This retrospective observational study included all patients who underwent defibrillator implantation between January 1996 and December 2012 in 3 centers in the province of Barcelona. The study included 69 patients (mean age [standard deviation], 44.8 [17] years; 79.3% men), 48 in primary prevention and 21 in secondary prevention. The mean number of risk factors per patient was 1.8 in the primary prevention group and 0.5 in the secondary prevention group (P=.029). The median follow-up duration was 40.5 months. The appropriate therapy rate was 32.7/100 patient-years in secondary prevention and 1.7/100 patient-years in primary prevention (P<.001). Overall mortality was 10.1%. Implant-related complications were experienced by 8.7% of patients, and 13% had inappropriate defibrillator discharges. In patients with a defibrillator for primary prevention, the appropriate therapy rate is extremely low, indicating the low predictive power of the current risk stratification criteria. Copyright © 2014 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

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.

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

PubMed

Stavrakis, Stavros; Asad, Zain; Reynolds, Dwight

2017-06-01

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

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.

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.

Ironic Technology: Old Age and the implantable cardioverter defibrillator in US health care

PubMed Central

Kaufman, Sharon R.; Mueller, Paul S.; Ottenberg, Abigale L.; Koenig, Barbara A.

2010-01-01

We take the example of cardiac devices, specifically the implantable cardioverter defibrillator, or ICD, to explore the complex cultural role of technology in medicine today. We focus on persons age 80 and above, for whom ICD use is growing in the U.S. We highlight an ironic feature of this device. While it postpones death and ‘saves’ life by thwarting a lethal heart rhythm, it also prolongs living in a state of dying from heart failure. In that regard the ICD is simultaneously a technology of life extension and dying. We explore that irony among the oldest age group -- those whose considerations of medical interventions are framed by changing societal assumptions of what constitutes premature death, the appropriate time for death and medicine’s goals in an aging society. Background to the rapidly growing use of this device among the elderly is the ‘technological imperative’ in medicine, bolstered today by the value given to evidence-based studies. We show how evidence contributes to standards of care and to the expansion of Medicare reimbursement criteria. Together, those factors shape the ethical necessity of physicians offering and patients accepting the ICD in late life. Two ethnographic examples document the ways in which those factors are lived in treatment discussions and in expectations about death and longevity. PMID:21126815

Incidence and management of prolonged charge times in the Medtronic model 7219 implantable cardioverter defibrillator.

PubMed

Mann, D E; Gleason, S A; Kelly, P A; Easley, A R; Reiter, M J

2001-06-01

The Medtronic Jewel PCD model 7219, introduced in 1994, was the first downsized, pectoral implantable cardioverter defibrillator (ICD), and many of these units are approaching or have reached the elective replacement indicator (ERI). Unlike later Medtronic ICDs and most other ICDs, in which ERI is defined by battery voltage, the ERI in the model 7219 series is defined when either the capacitor charge time to full output is repeatedly> or =14.5 s or when battery voltage is< or =4.91 V. In this study we examined which of the two ERI criteria was met first in patients with this device model. We also assessed the effects of manual dumping and recharging and of increasing the automatic capacitor reformation frequency on prolonged charge times. In 16 patients with follow-up <2 years, 15 reached the charge time ERI before battery voltage ERI. Manual dumping and recharging led to spuriously low charge times due to residual charge at the start of recharging, and increasing the automatic capacitor reformation frequency to once a month did not decrease prolonged charge times. Because of persistently prolonged charge times, 15 patients had generator changes. None of these patients had reached battery voltage ERI (battery voltage at time of explantation 5.06+/-0.06 V). Thus in this early pectoral device, prolonged charge times occur commonly before battery voltage ERI is reached. Whether prolonged charge times will have an impact on device longevity in later model ICDs is unknown.

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.

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

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.

What evidence do we have to replace in-hospital implantable cardioverter defibrillator follow-up?

PubMed

Brugada, P

2006-01-01

Due to the increasing number of patients with an implantable cardioverter defibrillator (ICD), new options for ICD patient follow-up management are required. Patients with ICD indication according to the guidelines received an ICD with Home Monitoring technology. The devices enabled the transmission of the relevant episode, therapy, and system integrity data. Patients were followed for 12 months with routine controls every 3 months. The physician analyzed the Home Monitoring data before the routine follow-up visit (FU) and gave a forecast on the necessity of the pending FU, which was compared with the evaluation after the FU. Based on the derived forecast reliability, a patient management scheme was developed and its impact on patient safety was assessed retrospectively. A total of 271 patients were enrolled (40 f, mean age 62+/-12 years, mean LVEF 39+/-15%, 65% ischemic heart disease, 20% cardiomyopathy) and followed for 339+/-109 days. Of 908 pairs of Home Monitoring data and FU data evaluation, 129 there were false negative results for 92 patients. Safety concerns from false negative forecasts can be minimized with a patient management scheme containing the following elements: 1) never skip the first routine FU; 2) never skip a routine FU for a patient having already shown pacing threshold problems; 3) perform FU following hospitalizations; 4) perform FU following episode detection by the ICD; and 5) perform a routine FU if the patient reports symptoms. The retrospective analysis showed, that if the patients had been managed using this scheme, 503 of 1079 routine FU could have been skipped with only one safety concern, a three month delay in the detection of silent paroxysmal atrial fibrillation in one patient. Home Monitoring in ICD therapy over 12 months is feasible. The data transmitted relevantly contribute to a remarkable reduction of follow-up burden and enable the individualization of routine follow-up.

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.

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.

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.

[Electrical storm in patients with prophylactic defibrillator implantation].

PubMed

Rodríguez-Mañero, Moisés; González-Cambeiro, Cristina; Moreno-Arribas, Jose; Expósito-García, Víctor; Sánchez-Gómez, Juan Miguel; González-Torres, Luis; Arce-León, Álvaro; Arguedas-Jiménez, Hugo; Gaztañaga, Larraitz; Salvador-Montañés, Oscar; Iglesias-Bravo, Jose Antonio; Huerta, Ana Andrés La; Fernández-Armenta, Juan; Arias, Miguel Ángel; Martínez-Sande, Luis

2016-01-01

Little is known about the prevalence of electrical storm, baseline characteristics and mortality implications of patients with implantable cardioverter defibrillator in primary prevention versus those patients without electrical storm. We sought to assess the prevalence, baseline risk profile and survival significance of electrical storm in patients with implantable defibrillator for primary prevention. Retrospective multicenter study performed in 15 Spanish hospitals. Consecutives patients referred for desfibrillator implantation, with or without left ventricular lead (at least those performed in 2010 and 2011), were included. Over all 1,174 patients, 34 (2,9%) presented an electrical storm, mainly due to ventricular tachycardia (82.4%). There were no significant baseline differences between groups, with similar punctuation in the mortality risk scores (SHOCKED, MADIT and FADES). A clear trigger was identified in 47% of the events. During the study period (38±21 months), long-term total mortality (58.8% versus 14.4%, p<0.001) and cardiac mortality (52.9% versus 8.6%, p<0.001) were both increased among electrical storm patients. Rate of inappropriate desfibrillator intervention was also higher (14.7 versus 8.6%, p<0.001). In the present study of patients with desfibrillator implantation for primary prevention, prevalence of electrical storm was 2.9%. There were no baseline differences in the cardiovascular risk profile versus those without electrical storm. However, all cause mortality and cardiovascular mortality was increased in these patients versus control desfibrillator patients without electrical storm, as was the rate of inappropriate desfibrillator intervention. Copyright © 2015 Instituto Nacional de Cardiología Ignacio Chávez. Published by Masson Doyma México S.A. All rights reserved.

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.

Sustaining cyborgs: sensing and tuning agencies of pacemakers and implantable cardioverter defibrillators.

PubMed

Oudshoorn, Nelly

2015-02-01

Recently there has been a renewed interest in cyborgs, and particularly in new and emerging fusions of humans and technologies related to the development of human enhancement technologies. These studies reflect a trend to follow new and emerging technologies. In this article, I argue that it is important to study 'older' and more familiar cyborgs as well. Studying 'the old' is important because it enables us to recognize hybrids' embodied experiences. This article addresses two of these older hybrids: pacemakers and implantable cardioverter defibrillators inserted in the bodies of people suffering from heart-rhythm disturbances. My concern with hybrid bodies is that internal devices seem to present a complex and neglected case if we wish to understand human agency. Their 'users' seem to be passive because they cannot exert any direct control over the working of their devices. Technologies inside bodies challenge a longstanding tradition of theorizing human-technology relations only in terms of technologies external to the body. Cyborg theory is problematic as well because most studies tend to conceptualize the cyborg merely as a discursive entity and silence the voices of people living as cyborgs. Inspired by feminist research that foregrounds the materiality of the lived and intimate relations between bodies and technologies, I argue that creating these intimate relations requires patients' active involvement in sustaining their hybrid bodies. Based on observations of these monitoring practices in a Dutch hospital and interviews with patients and technicians, the article shows that heart cyborgs are far from passive. On the contrary, their unique experience in sensing the entangled agencies of technologies and their own heart plays a crucial role in sustaining their hybrid bodies.

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.

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.

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.

Prevalence and mechanism of tricuspid regurgitation following implantation of endocardial leads for pacemaker or cardioverter-defibrillator.

PubMed

Al-Mohaissen, Maha A; Chan, Kwan Leung

2012-03-01

Endocardial lead-induced tricuspid regurgitation has not been well recognized, either clinically or echocardiographically, and yet it is likely a preventable iatrogenic disease. In severe cases, it can lead to right ventricular failure and require tricuspid valve surgery. This complication will become increasingly important, because the numbers of permanent pacemakers and implantable cardioverter-defibrillators are expected to increase because of the aging population and the expanding capabilities of these devices. Published studies are largely retrospective, and serial studies to assess the time course of the development of tricuspid regurgitation are lacking. The mechanisms and severity of tricuspid regurgitation may not be well evaluated by two-dimensional echocardiography. Real-time three-dimensional echocardiography appears to be a promising technique to evaluate the mechanism of tricuspid regurgitation and may allow the early detection of patients who will develop severe lead-induced tricuspid regurgitation. A better understanding of the mechanism of lead-induced tricuspid regurgitation will be essential to the development of preventive strategies, which can then be tested in future clinical trials. Copyright © 2012 American Society of Echocardiography. Published by Mosby, Inc. All rights reserved.

Work burden with remote monitoring of implantable cardioverter defibrillator: is it time for reimbursement policies?

PubMed

Papavasileiou, Lida P; Forleo, Giovanni B; Panattoni, Germana; Schirripa, Valentina; Minni, Valentina; Magliano, Giulia; Bellos, Kyriakos; Santini, Luca; Romeo, Francesco

2013-02-01

The efficacy and accuracy, as well as patients' satisfaction, of device remote monitoring are well demonstrated. However, the workload of remote monitoring management has not been estimated and reimbursement schemes are currently unavailable in most European countries. This study evaluates the workload associated with remote monitoring systems. A total of 154 consecutive implantable cardioverter defibrillator patients (age 66±12 years; 86.5% men) with a remote monitoring system were enrolled. Data on the clinician's workload required for the management of the patients were analyzed. A total of 1744 transmissions were received during a mean follow-up of 15.3±12.4 months. Median number of transmissions per patient was 11.3. There were 993 event-free transmissions, whereas 638 transmissions regarded one or more events (113 missed transmissions, 141 atrial events, 132 ventricular episodes, 299 heart failure-related transmissions, 14 transmissions regarding lead malfunction and 164 transmissions related to other events). In 402 cases telephonic contact was necessary, whereas in 68 cases an in-clinic visit was necessary and in 23 of them an in-clinic visit was prompted by the manufacturer due to technical issues of the transmitter. During follow-up, 316 work hours were required to manage the enrolled patients. Each month, a total of 14.9 h were spent on the remote monitoring of 154 patients (9.7 h for 100 patients monthly) with approximately 1.1±0.15 h per year for each patient. The clinician's work burden is high in patients with remote monitoring. In order to expand remote monitoring in all patients, reimbursement policies should be considered.

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

Pre-discharge defibrillation testing: Is it still justified?

PubMed

Kempa, Maciej; Królak, Tomasz; Drelich, Łukasz; Budrejko, Szymon; Daniłowicz-Szymanowicz, Ludmiła; Lewicka, Ewa; Kozłowski, Dariusz; Raczak, Grzegorz

2016-01-01

An implantable cardioverter-defibrillator (ICD) is routinely used to prevent sudden cardiac death. Since the introduction of that device into clinical practice, a defibrillation test (the so-called pre-discharge test [PDT]) has been an inseparable part of the ICD implantation procedure. Recently, the usefulness of PDT has been called into question. The aim of this research was to analyze ICD tests performed within two time periods: in years 1995-2001 (period I) and 2007-2010 (period II), in order to compare the results of tests and solutions to all the problems with ICD systems revealed by means of PDT. During period I, 193 tests were performed, among which the ICD system malfunction was observed in 16 cases. Those included: sensing issues, specifically R-wave undersensing during ventricular fibrillation (VF) (7 patients) and T-wave oversensing (4 patients), as well as high defibrillation threshold (DFT) (2 patients) and ICD-pacemaker interaction (3 patients). During period II, among 561 tests, system malfunction was observed in 15 cases. In 1 patient it was VF undersensing, and in the remaining 14 it was high DFT. All the above problems were solved by means of appropriate ICD reprogramming, repositioning of the endocardial defibrillation lead or implantation of an additional subcutaneous defibrillation lead. Contemporary ICD technical solutions, compared to older systems, in most cases allow to avoid sensing problems. The key rationale behind ICD testing is the ability to confirm the efficacy of high-voltage therapy. Despite the increasing maximal defibrillation out-put of devices, and all possible adjustments to the characteristics of the impulse, there is still a group of patients that require additional procedures to ensure the appropriate defibrillation efficacy.

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

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.

Percutaneous pacemaker or implantable cardioverter-defibrillator lead removal in an attempt to improve symptomatic tricuspid regurgitation.

PubMed

Nazmul, Mohammed N; Cha, Yong-Mei; Lin, Grace; Asirvatham, Samuel J; Powell, Brian D

2013-03-01

Pacemaker and implantable cardioverter-defibrillator (ICD) leads can cause tricuspid valve regurgitation (TR). Few data are available on the best management of significant TR that develops after pacemaker or ICD implantation and regarding any benefits of right ventricular (RV) lead extraction. We sought to determine the impact of RV lead removal on lead-induced TR. We reviewed all patients between 1 January 2000 and 31 December 2010 at the tertiary care hospital who had a preoperative indication of TR and underwent percutaneous extraction of an RV lead with the intent of trying to correct moderate or severe TR. Pre- and post-procedure echoes and clinical data were retrospectively reviewed. In the four patients identified, the RV lead was removed and placed in the coronary sinus to try to improve moderate or severe TR due to lead impingement. There was no significant improvement in the degree of TR except one patient where TR improved slightly from moderate to mild-moderate. All patients had a dilated tricuspid valve annulus by the time of lead extraction. Tricuspid annulus dilatation appeared to account for the persistent TR after RV lead removal. A greater degree of tricuspid valve annulus dilatation may be a marker and mechanism for irreversible lead-induced TR. Further studies are needed to determine whether surgical tricuspid valve repair or replacement combined with RV lead extraction would result in better outcomes than a percutaneous lead extraction approach.

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

Long-term follow-up study of uncertainty and psychosocial adjustment among implantable cardioverter defibrillator recipients.

PubMed

Mauro, Ann Marie P

2010-09-01

Sudden cardiac death is an international health issue. Implantable defibrillators have been effective in the secondary prevention of sudden cardiac death and are increasingly being utilized for primary prevention in individuals without a prior history of cardiac arrest or sustained ventricular tachycardia. Although it has been well documented that some recipients experience psychological distress and have difficulty in adjusting to the device, long-term data on psychological outcomes are limited. The aims of this study were to determine: (a) if there is a long-term relationship between uncertainty and psychosocial adjustment among implantable cardioverter defibrillator (ICD) recipients; and (b) if changes in uncertainty and/or adjustment occur over time. A longitudinal, descriptive, correlational design was used for this long-term follow-up study (M=9.4 years, SD=.23). Ninety-four patients from 4 major teaching hospitals in New England who had participated in an investigation of uncertainty and adjustment at 1 and 8 weeks following an initial ICD implant between 1996 and 1997 were solicited. From the original sample, 41 patients had expired (44%) and 5 had heart transplants (5%). Two individuals chose not to participate. Twenty-five persons (27%) were not found despite numerous attempts to locate them. The final sample included 21 subjects (22%). Following university institutional review board approval, a mail survey was administered using the Dillman method. Instruments included a demographic data questionnaire, the Psychosocial Adjustment to Illness Scale-Self-Report and the 2-factor version of the Mishel Uncertainty in Illness Scale. The final sample primarily included educated, married, white males. Uncertainty and adjustment levels did not change significantly over time. Early adjustment explained 40% of the variance in overall adjustment at long-term follow-up (P=.010). Men experienced significantly more uncertainty overall [t(19)=2.925, P=.009] and

Gender Differences in Appropriate Shocks and Mortality among Patients with Primary Prophylactic Implantable Cardioverter-Defibrillators: Systematic Review and Meta-Analysis.

PubMed

Conen, David; Arendacká, Barbora; Röver, Christian; Bergau, Leonard; Munoz, Pascal; Wijers, Sofieke; Sticherling, Christian; Zabel, Markus; Friede, Tim

2016-01-01

Some but not all prior studies have shown that women receiving a primary prophylactic implantable cardioverter defibrillator (ICD) have a lower risk of death and appropriate shocks than men. To evaluate the effect of gender on the risk of appropriate shock, all-cause mortality and inappropriate shock in contemporary studies of patients receiving a primary prophylactic ICD. PubMed, LIVIVO, Cochrane CENTRAL between 2010 and 2016. Studies providing at least 1 gender-specific risk estimate for the outcomes of interest. Abstracts were screened independently for potentially eligible studies for inclusion. Thereby each abstract was reviewed by at least two authors. Out of 680 abstracts retained by our search strategy, 20 studies including 46'657 patients had gender-specific information on at least one of the relevant endpoints. Mean age across the individual studies varied between 58 and 69 years. The proportion of women enrolled ranged from 10% to 30%. Across 6 available studies, women had a significantly lower risk of first appropriate shock compared with men (pooled multivariable adjusted hazard ratio 0.62 (95% CI [0.44; 0.88]). Across 14 studies reporting multivariable adjusted gender-specific hazard ratio estimates for all-cause mortality, women had a lower risk of death than men (pooled hazard ratio 0.75 (95% CI [0.66; 0.86]). There was no statistically significant difference for the incidence of first inappropriate shocks (3 studies, pooled hazard ratio 0.99 (95% CI [0.56; 1.73]). Individual patient data were not available for most studies. In this large contemporary meta-analysis, women had a significantly lower risk of appropriate shocks and death than men, but a similar risk of inappropriate shocks. These data may help to select patients who benefit from primary prophylactic ICD implantation.

Battery drain in daily practice and medium-term projections on longevity of cardioverter-defibrillators: an analysis from a remote monitoring database.

PubMed

Boriani, Giuseppe; Ritter, Philippe; Biffi, Mauro; Ziacchi, Matteo; Diemberger, Igor; Martignani, Cristian; Valzania, Cinzia; Valsecchi, Sergio; Padeletti, Luigi; Gadler, Fredrik

2016-09-01

The longevity of generators is a crucial determinant of the cost-effectiveness of therapy with implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-D). We evaluated the trend of device-measured residual battery capacity and longevity projections over 5-year follow-up. We also investigated possible factors associated with battery drain. Data from 4851 patients in the European LATITUDE(®) database who were followed up for a minimum of 3 years were analysed. The factors associated with battery drain (i.e. year-to-year decrease in residual battery capacity), and thus potentially impacting on device longevity, were mainly the pacing parameters in CRT-D devices and the number of shocks delivered and diverted in both ICD and CRT-D (all P < 0.01 on linear regression analysis). Over the first 5 years, the longevity estimates provided by devices showed low intra-patient variability and increased with time. The estimates exceeded 10 years for CRT-D and 13 and 12 years for single- and dual-chamber ICDs, respectively. In CRT-D patients, the expected patient age on replacement was 80 ± 12 years, and the expected probability of undergoing device replacement was 63 ± 13% for New York Heart Association (NYHA) II patients and 37 ± 16% for NYHA III patients. For comparison, the probabilities of replacing a CRT-D lasting 5 years were 78 ± 8 and 59 ± 13%, respectively (both P < 0.001). Battery drain was mainly associated with pacing output in CRT-D devices and with the number of capacitor charges in both ICD and CRT-D devices. The longevity estimates provided by the devices were consistent and conservative. According to these estimates, among CRT-D recipients a low proportion of patients should require device replacement. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

Battery drain in daily practice and medium-term projections on longevity of cardioverter-defibrillators: an analysis from a remote monitoring database

PubMed Central

Boriani, Giuseppe; Ritter, Philippe; Biffi, Mauro; Ziacchi, Matteo; Diemberger, Igor; Martignani, Cristian; Valzania, Cinzia; Valsecchi, Sergio; Padeletti, Luigi; Gadler, Fredrik

2016-01-01

Aims The longevity of generators is a crucial determinant of the cost-effectiveness of therapy with implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-D). We evaluated the trend of device-measured residual battery capacity and longevity projections over 5-year follow-up. We also investigated possible factors associated with battery drain. Methods and results Data from 4851 patients in the European LATITUDE® database who were followed up for a minimum of 3 years were analysed. The factors associated with battery drain (i.e. year-to-year decrease in residual battery capacity), and thus potentially impacting on device longevity, were mainly the pacing parameters in CRT-D devices and the number of shocks delivered and diverted in both ICD and CRT-D (all P < 0.01 on linear regression analysis). Over the first 5 years, the longevity estimates provided by devices showed low intra-patient variability and increased with time. The estimates exceeded 10 years for CRT-D and 13 and 12 years for single- and dual-chamber ICDs, respectively. In CRT-D patients, the expected patient age on replacement was 80 ± 12 years, and the expected probability of undergoing device replacement was 63 ± 13% for New York Heart Association (NYHA) II patients and 37 ± 16% for NYHA III patients. For comparison, the probabilities of replacing a CRT-D lasting 5 years were 78 ± 8 and 59 ± 13%, respectively (both P < 0.001). Conclusion Battery drain was mainly associated with pacing output in CRT-D devices and with the number of capacitor charges in both ICD and CRT-D devices. The longevity estimates provided by the devices were consistent and conservative. According to these estimates, among CRT-D recipients a low proportion of patients should require device replacement. PMID:26847076

Interaction between shock coils increased the incidence of inappropriate therapies and lead failure in implantable cardioverter defibrillator.

PubMed

El Garhy, Mohammad; Ohlow, Marc-Alexander; Lauer, Bernward

Shock coil interaction in patients with multiple implantable cardioverter defibrillator (ICD) leads is occasionally observed. We aimed to evaluate the incidence of shock coil interaction and its clinical relevance. All ICD patients (646 patients) who came to follow up control in our ICD ambulance between January 1, 2011, and December 31, 2011 in the department of cardiology in Bad Berka hospital were retrospectively evaluated in this study. All baseline demographic, clinical, and procedural characteristics and postoperative chest x ray in postero-anterior and lateral view as well as clinical and ICD follow up data were evaluated. Among 646 patients 42 had multiple ICD leads (6.5%) of whom 36 patients (5.5% of total cohort patients and 85.7% of patients with multiple ICD leads) had shock coil interaction and presented the study group (Group I). The control group (Group II) consisted of 610 patients without coil-coil interaction including patients with single shock lead (604 patients) or patients with multiple leads but without interaction between shock coils (6 patients). Inappropriate anti-tachycardia therapies and RV lead revisions were more frequent in patients with interaction between shock coils (Group I vs Group II: 27.7% and 5.7%; p = 0.049 and 30.6% vs 6.4; p = 0.0001, respectively). Interaction between shock coils may be one of possible causes of lead failure and resulted in inappropriate therapies and subsequent lead revision. Copyright © 2018 Indian Heart Rhythm Society. Production and hosting by Elsevier B.V. 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

Association of Air Pollution with Increased Incidence of Ventricular Tachyarrhythmias Recorded by Implanted Cardioverter Defibrillators

PubMed Central

Dockery, Douglas W.; Luttmann-Gibson, Heike; Rich, David Q.; Link, Mark S.; Mittleman, Murray A.; Gold, Diane R.; Koutrakis, Petros; Schwartz, Joel D.; Verrier, Richard L.

2005-01-01

Epidemiologic studies have demonstrated a consistent link between sudden cardiac deaths and particulate air pollution. We used implanted cardioverter defibrillator (ICD) records of ventricular tachyarrhythmias to assess the role of air pollution as a trigger of these potentially life-threatening events. The study cohort consisted of 203 cardiac patients with ICD devices in the Boston metropolitan area who were followed for an average of 3.1 years between 1995 and 2002. Fine particle mass and gaseous air pollution plus temperature and relative humidity were measured on almost all days, and black carbon, sulfate, and particle number on a subset of days. Date, time, and intracardiac electrograms of ICD-detected arrhythmias were downloaded at the patients’ regular follow-up visits (about every 3 months). Ventricular tachyarrhythmias were identified by electrophysiologist review. Risk of ventricular arrhythmias associated with air pollution was estimated with logistic regression, adjusting for season, temperature, relative humidity, day of the week, patient, and a recent prior arrhythmia. We found increased risks of ventricular arrhythmias associated with 2-day mean exposure for all air pollutants considered, although these associations were not statistically significant. We found statistically significant associations between air pollution and ventricular arrhythmias for episodes within 3 days of a previous arrhythmia. The associations of ventricular tachyarrhythmias with fine particle mass, carbon monoxide, nitrogen dioxide, and black carbon suggest a link with motor vehicle pollutants. The associations with sulfate suggest a link with stationary fossil fuel combustion sources. PMID:15929887

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.

The impact of body mass index on the wearable cardioverter defibrillator shock efficacy and patient wear time.

PubMed

Wan, Chingping; Szymkiewicz, Steven J; Klein, Helmut U

2017-04-01

The impact of body mass index (BMI) on the shock efficacy and patient adherence among patients using a wearable cardioverter defibrillator (WCD) is unknown. Patients prescribed the WCD between January 1, 2008 and June 1, 2013, who experienced at least one episode of sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) and who received appropriate WCD therapy, were identified within a registry maintained by the manufacturer for regulatory, reimbursement, and administrative purposes. The registry contained patients' Body Mass Index (BMI) which was categorized as normal (18.0patients were included in the final analyses. Patient characteristics were similar across all groups except the obese group (60±11 years) was younger than the normal (63±16 years) and overweight (64±12 years, P=.001) groups. Mean length of use for normal, overweight and obese groups was 79±131, 82±202 and 55±97 days (P=.12), respectively; the median daily wear time was 21 hours among all groups. In a total of 623 VT/VF events, the median TTI was 44 ohms, 51 ohms and 65 ohms for normal, overweight and obese groups, respectively; TTI was positively correlated to BMI (r=0.33, P<.01). First-shock conversion rate was 92.9% in the normal group, 93.6% and 93.9% in the overweight and obese groups, respectively (P=.93). There was no difference in 24-hour survival among the three groups (91.9%, 94.1% and 92.3%, P=.66). The WCD first-shock success rate and post-event 24-hour survival were high and independent from BMI. TTI was positively

Critical analysis of dual-chamber implantable cardioverter-defibrillator arrhythmia detection : results and technical considerations.

PubMed

Wilkoff, B L; Kühlkamp, V; Volosin, K; Ellenbogen, K; Waldecker, B; Kacet, S; Gillberg, J M; DeSouza, C M

2001-01-23

One of the perceived benefits of dual-chamber implantable cardioverter-defibrillators (ICDs) is the reduction in inappropriate therapy due to new detection algorithms. It was the purpose of the present investigation to propose methods to minimize bias during such comparisons and to report the arrhythmia detection clinical results of the PR Logic dual-chamber detection algorithm in the GEM DR ICD in the context of these methods. Between November 1997 and October 1998, 933 patients received the GEM DR ICD in this prospective multicenter study. A total of 4856 sustained arrhythmia episodes (n=311) with stored electrogram and marker channel were classified by the investigators; 3488 episodes (n=232) were ventricular tachycardia (VT)/ventricular fibrillation (VF), and 1368 episodes (n=149) were supraventricular tachycardia (SVT). The overall detection results were corrected for multiple episodes within a patient with the generalized estimating equations (GEE) method with an exchangeable correlation structure between episodes. The relative sensitivity for detection of sustained VT and/or VF was 100.0% (3488 of 3488, n=232; 95% CI 98.3% to 100%), the VT/VF positive predictivity was 88.4% uncorrected (3488 of 3945, n=278) and 78.1% corrected (95% CI 73.3% to 82.3%) with the GEE method, and the SVT positive predictivity was 100.0% (911 of 911, n=101; 95% CI 96% to 100%). A structured approach to analysis limits the bias inherent in the evaluation of tachycardia discrimination algorithms through the use of relative VT/VF sensitivity, VT/VF positive predictivity, and SVT positive predictivity along with corrections for multiple tachycardia episodes in a single patient.

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.

BAYESIAN META-ANALYSIS ON MEDICAL DEVICES: APPLICATION TO IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

PubMed Central

Youn, Ji-Hee; Lord, Joanne; Hemming, Karla; Girling, Alan; Buxton, Martin

2012-01-01

Objectives: The aim of this study is to describe and illustrate a method to obtain early estimates of the effectiveness of a new version of a medical device. Methods: In the absence of empirical data, expert opinion may be elicited on the expected difference between the conventional and modified devices. Bayesian Mixed Treatment Comparison (MTC) meta-analysis can then be used to combine this expert opinion with existing trial data on earlier versions of the device. We illustrate this approach for a new four-pole implantable cardioverter defibrillator (ICD) compared with conventional ICDs, Class III anti-arrhythmic drugs, and conventional drug therapy for the prevention of sudden cardiac death in high risk patients. Existing RCTs were identified from a published systematic review, and we elicited opinion on the difference between four-pole and conventional ICDs from experts recruited at a cardiology conference. Results: Twelve randomized controlled trials were identified. Seven experts provided valid probability distributions for the new ICDs compared with current devices. The MTC model resulted in estimated relative risks of mortality of 0.74 (0.60–0.89) (predictive relative risk [RR] = 0.77 [0.41–1.26]) and 0.83 (0.70–0.97) (predictive RR = 0.84 [0.55–1.22]) with the new ICD therapy compared to Class III anti-arrhythmic drug therapy and conventional drug therapy, respectively. These results showed negligible differences from the preliminary results for the existing ICDs. Conclusions: The proposed method incorporating expert opinion to adjust for a modification made to an existing device may play a useful role in assisting decision makers to make early informed judgments on the effectiveness of frequently modified healthcare technologies. PMID:22559753

Association of air pollution with increased incidence of ventricular tachyarrhythmias recorded by implantable cardioverter defibrillators: Vulnerable patients to air pollution.

PubMed

Kim, In-Soo; Sohn, Jungwoo; Lee, Seung-Jun; Park, Jin-Kyu; Uhm, Jae-Sun; Pak, Hui-Nam; Lee, Moon-Hyoung; Kim, Changsoo; Joung, Boyoung

2017-08-01

This study investigated the acute effects of exposure to air pollution on ventricular tachyarrhythmias (VTAs) in an East Asian population. The association between air pollution and VTA has not yet been studied in an East Asian country affected by the Asian dust phenomenon, which worsens air quality. The study cohort consisted of 160patients with implantable cardioverter defibrillator (ICD) devices in the Seoul metropolitan area who were followed for 5.5±3.8years. We used ICD records of VTAs and matched these with hourly measurements of air pollutant concentrations and meteorological data. Fine particle mass and gaseous air pollution plus temperature and relative humidity were measured hourly during the study period. During the study period, 1064 VTA events including 204 instances of ventricular fibrillation (VF) were observed. We found a statistically significant association between overall VTA events and SO 2 (lag 24h; OR 1.49, 95%CI 1.16-1.92, p=0.002), PM 10 (lag 2h; OR 2.56, 95%CI 2.03-3.23, p<0.001), NO 2 (lag 24h; OR 1.25, 95%CI 1.19-1.31, p<0.001) and CO (lag 24h; OR 1.05, 95%CI 1.02-1.08, p=0.003). Sustained ventricular tachycardia or VF was also independently associated with SO 2 , PM 10 , NO 2 and CO (all p<0.01). Exposures to SO 2 , PM 10 , NO 2 , and CO (all p<0.01) were significantly related to overall VTAs, especially in patients with structural heart disease (SHD). Associations between air pollution and VTA were observed in a metropolitan area of an East Asian country. Exposures to SO 2 , PM 10 , NO 2 , and CO were significantly associated with VTAs in ICD patients with SHD. Copyright © 2017 Elsevier B.V. All rights reserved.

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

Initial Experience of an Anesthesiology-based Service for Perioperative Management of Pacemakers and Implantable Cardioverter Defibrillators.

PubMed

Rooke, G Alec; Lombaard, Stefan A; Van Norman, Gail A; Dziersk, Jörg; Natrajan, Krishna M; Larson, Lyle W; Poole, Jeanne E

2015-11-01

Management of cardiovascular implantable electronic devices (CIEDs), including pacemakers and implantable cardioverter defibrillators, for surgical procedures is challenging due to the increasing number of patients with CIEDs and limited availability of trained providers. At the authors' institution, a small group of anesthesiologists were trained to interrogate CIEDs, devise a management plan, and perform preoperative and postoperative programming and device testing whenever necessary. Patients undergoing surgery between October 1, 2009 and June 30, 2013 at the University of Washington Medical Center were included in a retrospective chart review to determine the number of devices actively managed by the Electrophysiology/Cardiology Service (EPCS) versus the Anesthesiology Device Service (ADS), changes in workload over time, surgical case delays due to device management, and errors and problems encountered in device programming. The EPCS managed 254 CIEDs, the ADS managed 548, and 227 by neither service. Over time, the ADS providers managed an increasing percentage of devices with decreasing supervision from the EPCS. Only two CIEDs managed by the ADS required immediate assistance from the EPCS. Patients who were unstable postoperatively were referred to the EPCS. Although numerous issues in programming were encountered, primarily when restoring demand pacing after programming asynchronous pacing for surgery, no patient harm resulted from ADS or EPCS management of CIEDs. An ADS can provide safe CIED management for surgery, but it requires specialized provider training and strong support from the EPCS. Due to the complexity of CIED management, an ADS will likely only be feasible in high-volume settings.

Extended charge banking model of dual path shocks for implantable cardioverter defibrillators

PubMed Central

Dosdall, Derek J; Sweeney, James D

2008-01-01

Background Single path defibrillation shock methods have been improved through the use of the Charge Banking Model of defibrillation, which predicts the response of the heart to shocks as a simple resistor-capacitor (RC) circuit. While dual path defibrillation configurations have significantly reduced defibrillation thresholds, improvements to dual path defibrillation techniques have been limited to experimental observations without a practical model to aid in improving dual path defibrillation techniques. Methods The Charge Banking Model has been extended into a new Extended Charge Banking Model of defibrillation that represents small sections of the heart as separate RC circuits, uses a weighting factor based on published defibrillation shock field gradient measures, and implements a critical mass criteria to predict the relative efficacy of single and dual path defibrillation shocks. Results The new model reproduced the results from several published experimental protocols that demonstrated the relative efficacy of dual path defibrillation shocks. The model predicts that time between phases or pulses of dual path defibrillation shock configurations should be minimized to maximize shock efficacy. Discussion Through this approach the Extended Charge Banking Model predictions may be used to improve dual path and multi-pulse defibrillation techniques, which have been shown experimentally to lower defibrillation thresholds substantially. The new model may be a useful tool to help in further improving dual path and multiple pulse defibrillation techniques by predicting optimal pulse durations and shock timing parameters. PMID:18673561

Wearable defibrillator use in heart failure (WIF): results of a prospective registry

PubMed Central

2012-01-01

Background Heart failure (HF) patients have a high risk of death, and implantable cardioverter defibrillators (ICDs) are effective in preventing sudden cardiac death (SCD). However, a certain percentage of patients may not be immediate candidates for ICDs, particularly those having a short duration of risk or an uncertain amount of risk. This includes the newly diagnosed patients, as well as those on the cardiac transplant list or NYHA class IV heart failure patients who do not already have an ICD. In these patients, a wearable cardioverter defibrillator (WCD) may be used until long term risk of SCD is defined. The purpose of this study was to determine the incidence of SCD in this population, and the efficacy of early defibrillation by a WCD. Methods Ten enrolling centers identified 89 eligible HF patients who were either listed for cardiac transplantation, diagnosed with dilated cardiomyopathy, or receiving inotropic medications. Data collected included medical history, device records, and outcomes (including 90 day mortality). Results Out of 89 patients, final data on 82 patients has been collected. Patients wore the device for 75±58 days. Mean age was 56.8±13.2, and 72% were male. Most patients (98.8%) were diagnosed with dilated cardiomyopathy with a low ejection fraction (<40%) and twelve were listed for cardiac transplantation. Four patients were on inotropes. There were no sudden cardiac arrests or deaths during the study. Interestingly, 41.5% of patients were much improved after WCD use, while 34.1% went on to receive an ICD. Conclusions In conclusion, the WCD monitored HF patients until further assessment of risk. The leading reasons for end of WCD use were improvement in left ventricular ejection fraction (LVEF) or ICD implantation if there was no significant improvement in LVEF. PMID:23234574

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 fractionpatients 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.

Ventricular tachycardia

MedlinePlus

... called ablation ) may be done. An implantable cardioverter defibrillator (ICD) may be used. It is a device ... V tach; Tachycardia - ventricular Patient Instructions Implantable cardioverter defibrillator - discharge Images Implantable cardioverter-defibrillator References Garan H. ...

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.

Importance of the atrial channel for ventricular arrhythmia therapy in the dual chamber implantable cardioverter defibrillator.

PubMed

Dijkman, B; Wellens, H J

2000-12-01

Performance of dual chamber implantable cardioverter defibrillator (ICD) systems has been judged based on functioning of the ventricular tachycardia:supraventricular tachycardia (VT:SVT) discrimination criteria and DDD pacing. The purpose of this study was to evaluate the use of dual chamber diagnostics to improve the electrical and antiarrhythmic therapy of ventricular arrhythmias. Information about atrial and ventricular rhythm in relation to ventricular arrhythmia occurrence and therapy was evaluated in 724 spontaneous arrhythmia episodes detected and treated by three types of dual chamber ICDs in 41 patients with structural heart disease. Device programming was based on clinically documented and induced ventricular arrhythmias. In ambulatory patients, sinus tachycardia preceded ventricular arrhythmias more often than in the hospital during exercise testing. The incidence of these VTs could be reduced by increasing the dose of a beta-blocking agent in only two patients. In five patients in whom sinus tachycardia developed after onset of hemodynamic stable VT, propranolol was more effective than Class III antiarrhythmics combined with another beta-blocking agent with regard to the incidence of VT and pace termination. In all but three cases, atrial arrhythmias were present for a longer time before the onset of ventricular arrhythmias. During atrial arrhythmias, fast ventricular rates before the onset of ventricular rate were observed more often than RR irregularities and short-long RR sequences. Dual chamber diagnostics allowed proper interpretation of detection and therapy outcome in patients with different types of ventricular arrhythmia. The advantages of the dual chamber ICD system go further than avoiding the shortcomings of the single chamber system. Information from the atrial chamber allows better device programming and individualization of drug therapy for ventricular arrhythmia.

Significant Discrepancy Between Estimated and Actual Longevity in St. Jude Medical Implantable Cardioverter-Defibrillators.

PubMed

Doppalapudi, Harish; Barrios, James; Cuellar, Jose; Gannon, Melanie; Yamada, Takumi; Kumar, Vineet; Maddox, William R; Plumb, Vance J; Brown, Todd M; McElderry, H Tom

2017-05-01

Real-time estimated longevity has been reported in pacemakers for several years, and was recently introduced in implantable cardioverter-defibrillators (ICDs). We sought to evaluate the accuracy of this longevity estimate in St. Jude Medical (SJM) ICDs, especially as the device battery approaches depletion. Among patients with SJM ICDs who underwent generator replacements due to reaching elective replacement indicator (ERI) at our institution, we identified those with devices that provided longevity estimates and reviewed their device interrogations in the 18 months prior to ERI. Significant discrepancy was defined as a difference of more than 12 months between estimated and actual longevity at any point during this period. Forty-six patients with Current/Promote devices formed the study group (40 cardiac resynchronization therapy [CRT] and 6 single/dual chamber). Of these, 34 (74%) had significant discrepancy between estimated and actual longevity (28 CRT and all single/dual). Longevity was significantly overestimated by the device algorithm (mean maximum discrepancy of 18.8 months), more in single/dual than CRT devices (30.5 vs. 17.1 months). Marked discrepancy was seen at voltages ≥2.57 volts, with maximum discrepancy at 2.57 volts (23 months). The overall longevity was higher in the discrepant group of CRT devices than in the nondiscrepant group (67 vs. 61 months, log-rank P = 0.03). There was significant overestimation of longevity in nearly three-fourths of Current/Promote SJM ICDs in the last 18 months prior to ERI. Longevity estimates of SJM ICDs may not be reliable for making clinical decisions on frequency of follow-up, as the battery approaches depletion. © 2017 Wiley Periodicals, Inc.

[The daily experience of the patient with an implantable cardioverter defibrillator].

PubMed

Palacios-Ceña, Domingo; Alonso-Blanco, Cristina; Cachón-Pérez, José Miguel; Alvarez-López, Cristina

2010-01-01

To describe the daily experience of patients with an automatic defibrillator (AD) implant and the adaptive changes of the patient. Qualitative and phenomenological research. Collection of data through; initially unstructured interview with half of the informants, semi-structured interviews through an open questions guide after the initial unstructured interviews and use of personal narratives of the informants. Analysis of the data using the Van Manen proposal. We analysed the interviews of 10 participants. We collected socio-demographic variables and identified the following themes, which respond to the question "How is life with an AD": It is life "with the two sides of the coin," living in constant wait and uncertainty, accepting change, developing adaptation strategies, renegotiating relationships and sexuality and it is to live transformed. The results of this study can be integrated into nurse clinical practice in areas such as valuation after discharge, changes in habits, control of treatment, notification of shocks, masking detection of symptoms and strategies that can jeopardise the bearer. Research needs to be developed that looks closer into the influence of other technological devices in people. Copyright 2009 Elsevier España, S.L. 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.

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.

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.

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

PubMed

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

2017-06-07

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

The use of wearable cardioverter-defibrillators in Europe: results of the European Heart Rhythm Association survey.

PubMed

Lenarczyk, Radosław; Potpara, Tatjana S; Haugaa, Kristina H; Hernández-Madrid, Antonio; Sciaraffia, Elena; Dagres, Nikolaos

2016-01-01

The aim of this European Heart Rhythm Association (EHRA) survey was to collect data on the use of wearable cardioverter-defibrillators (WCDs) among members of the EHRA electrophysiology research network. Of the 50 responding centres, 23 (47%) reported WCD use. Devices were fully reimbursed in 17 (43.6%) of 39 respondents, and partially reimbursed in 3 centres (7.7%). Eleven out of 20 centres (55%) reported acceptable patients' compliance (WCD worn for >90% of time). The most common indications for WCD (8 out of 10 centres; 80%) were covering the period until re-implantation of ICD explanted due to infection, in patients with left ventricular impairment due to myocarditis or recent myocardial infarction and those awaiting heart transplantation. Patient life expectancy of <12 months and poor compliance were the most commonly reported contraindications for WCD (24 of 46 centres, 52.2%). The major problems encountered by physicians managing patients with WCD were costs (8 of 18 centres, 44.4%), non-compliance, and incorrect use of WCD. Four of 17 centres (23.5%) reported inappropriate WCD activations in <5% of patients. The first shock success rate in terminating ventricular arrhythmias was 95-100% in 6 of 15 centres (40%), 85-95% in 4 (26.7%), 75-85% in 2 (13.3%), and <75% in 3 centres (20%). The survey has shown that the use of WCD in Europe is still restricted and depends on reimbursement. Patients' compliance remains low. Heterogeneity of indications for WCD among centres underscores the need for further research and a better definition of indications for WCD in specific patient groups. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

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.

Statins reduce appropriate implantable cardioverter-defibrillator shocks in ischemic cardiomyopathy with no benefit in nonischemic cardiomyopathy.

PubMed

Contractor, Tahmeed; Beri, Abhimanyu; Gardiner, Joseph; Ardhanari, Sivakumar; Thakur, Ranjan

2012-11-01

Statins have been hypothesized to decrease ventricular arrhythmias through a direct antiarrhythmic effect. Clinical studies have demonstrated a clear reduction only in populations with underlying ischemic heart disease. This study was designed to compare the effect of statins on appropriate shocks between ischemic and nonischemic cardiomyopathy. Patients with an ejection fraction 35% or less who received an implantable cardioverter-defibrillator and had follow-up for at least 1 month were included. The ischemic and nonischemic groups were divided into statin treatment and control subgroups and the occurrence of appropriate shocks was compared. The frequency of shocks was analyzed using negative binomial models to account for overdispersion of the "count" data (number of appropriate shocks) and an adjusted intensity rate ratio was calculated for statin use. A total of 676 patients were included, of which statins were used by 65% (329 of 506) of the ischemic and 42% (72 of 170) of the nonischemic groups. Occurrence of appropriate shocks was significantly reduced with statins in ischemic (13.4% vs 20.9%; relative risk 0.64, P = 0.028), but not in the patients with nonischemic cardiomyopathy. Similarly, although use of statins lowered the intensity rate of appropriate shocks in ischemic patients (intensity rate ratio, 0.23; 95% confidence interval, 0.12-0.47), no such benefit was noted in the nonischemic group (intensity rate ratio, 1.27; 95% confidence interval, 0.37-4.40). In conclusion, statins reduced the occurrence and frequency of appropriate shocks for ventricular arrhythmias in ischemic but not in nonischemic cardiomyopathy. Larger, randomized controlled trials are needed to confirm these findings.

Contemporary rates and outcomes of single- vs. dual-coil implantable cardioverter defibrillator lead implantation: data from the Israeli ICD Registry.

PubMed

Leshem, Eran; Suleiman, Mahmoud; Laish-Farkash, Avishag; Konstantino, Yuval; Glikson, Michael; Barsheshet, Alon; Goldenberg, Ilan; Michowitz, Yoav

2017-09-01

Dual-coil leads were traditionally considered standard of care due to lower defibrillation thresholds (DFT). Higher complication rates during extraction with parallel progression in implantable cardioverter defibrillator (ICD) technology raised questions on dual coil necessity. Prior substudies found no significant outcome difference between dual and single coils, although using higher rates of DFT testing then currently practiced. We evaluated the temporal trends in implantation rates of single- vs. dual-coil leads and determined the associated adverse clinical outcomes, using a contemporary nation-wide ICD registry. Between July 2010 and March 2015, 6343 consecutive ICD (n = 3998) or CRT-D (n = 2345) implantation patients were prospectively enrolled in the Israeli ICD Registry. A follow-up of at least 1 year of 2285 patients was available for outcome analysis. The primary endpoint was all-cause mortality. Single-coil leads were implanted in 32% of our cohort, 36% among ICD recipients, and 26% among CRT-D recipients. Secondary prevention indication was associated with an increased rate of dual-coil implantation. A significant decline in dual-coil leads with reciprocal incline of single coils was observed, despite low rates of DFT testing (11.6%) during implantation, which also declined from 31 to 2%. In the multivariate Cox model analysis, dual- vs. single-coil lead implantation was not associated with an increased risk of mortality [hazard ratio (HR) = 1.23; P= 0.33], heart failure hospitalization (HR = 1.34; P=0.13), appropriate (HR = 1.25; P= 0.33), or inappropriate ICD therapy (HR = 2.07; P= 0.12). Real-life rates of single-coil lead implantation are rising while adding no additional risk. These results of single-coil safety are reassuring and obtained, despite low and contemporary rates of DFT testing. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

The role of implantable cardioverter defibrillators in patients bridged to transplantation with a continuous-flow left ventricular assist device: A propensity score matched analysis.

PubMed

Clerkin, Kevin J; Topkara, Veli K; Mancini, Donna M; Yuzefpolskaya, Melana; Demmer, Ryan T; Dizon, Jose M; Takeda, Koji; Takayama, Hiroo; Naka, Yoshifumi; Colombo, Paolo C; Garan, A Reshad

2017-06-01

Implantable cardioverter defibrillators (ICDs) provide a significant mortality benefit for appropriately selected patients with advanced heart failure. ICDs are associated with a mortality benefit when used in patients with a pulsatile left ventricular assist device (LVAD). It is unclear whether patients with a continuous-flow LVAD (CF-LVAD) derive the same benefit. We sought to determine if the presence of an ICD provided a mortality benefit during CF-LVAD support as a bridge to transplantation. Patients were identified in the United Network for Organ Sharing (UNOS) registry who underwent LVAD implantation as bridge to transplantation between May 2004 and April 2014, with follow-up through June 2014. Primary outcome was freedom from death while on CF-LVAD support with adjustment for complications requiring UNOS listing status upgrade. Secondary end-points included freedom from delisting while on CF-LVAD support and incidence of transplantation. The study cohort comprised 2,990 patients, and propensity score matching identified 1,012 patients with similar propensity scores. There was no difference in survival during device support between patients with and without an ICD (hazard ratio [HR] = 1.20; 95% confidence interval [CI], 0.66-2.17; p = 0.55). Adjusting for device complications requiring a UNOS listing status upgrade had minimal influence (HR = 1.11; 95% CI, 0.60-2.05; p = 0.74). There was no increased risk of delisting owing to being too sick for patients with an ICD (HR = 1.08; 95% CI, 0.63-1.86; p = 0.78). Likewise, the probability of transplantation was similar (HR = 1.05; 95% CI, 0.87-1.27; p = 0.62). Among patients bridged to transplantation with a CF-LVAD, the presence of an ICD did not reduce mortality. Copyright © 2017 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Heart rate in patients with reduced ejection fraction: relationship between single time point measurement and mean heart rate on prolonged implantable cardioverter defibrillator monitoring.

PubMed

Habal, Marlena V; Nanthakumar, Kumaraswamy; Austin, Peter C; Freitas, Cassandra; Labos, Christopher; Lee, Douglas S

2018-01-31

Heart rate (HR) is a prognostic marker that is increasingly used as a therapeutic target in patients with cardiovascular disease. The association between resting and mean HR remains unclear. We therefore set out to determine the relationship between resting HR on the electrocardiogram (ECG) obtained at a single time point, and mean HR on implantable cardioverter defibrillator (ICD) interrogation amongst patients with a reduced left ventricular ejection fraction (LVEF). Prospective ICD data were obtained from 54 patients with LVEF < 40%. Mean HR determined using the ICD HR histograms was compared with resting HR measured on the ECG performed in the clinic. Average resting and ICD mean HRs were 67.9 ± 10.1 and 67.8 ± 9.6 bpm respectively. There was good correlation in the overall cohort (r = 0.79), in those with resting ECG HRs ≤ 70 bpm (r = 0.62), and amongst the 27 patients on intermediate-to-high dose beta-blockers (r = 0.91). However, Bland-Altman analysis demonstrated wide limits of agreement in the overall cohort (- 12.5, 12.7 bpm), at resting HRs ≤ 70 bpm (- 12.7, 9.8 bpm), and on intermediate-to-high dose beta-blockers (- 8.9, 7.4 bpm). Moreover, resting HR did not predict the 10-bpm interval where the most time was spent. While resting HR correlated with mean HR in patients with reduced LVEF, and in important subgroups, the limits of agreement were unacceptably wide raising concern over the use of single time point resting HR as a therapeutic target.

Development and testing of an algorithm to detect implantable cardioverter-defibrillator lead failure.

PubMed

Gunderson, Bruce D; Gillberg, Jeffrey M; Wood, Mark A; Vijayaraman, Pugazhendhi; Shepard, Richard K; Ellenbogen, Kenneth A

2006-02-01

Implantable cardioverter-defibrillator (ICD) lead failures often present as inappropriate shock therapy. An algorithm that can reliably discriminate between ventricular tachyarrhythmias and noise due to lead failure may prevent patient discomfort and anxiety and avoid device-induced proarrhythmia by preventing inappropriate ICD shocks. The goal of this analysis was to test an ICD tachycardia detection algorithm that differentiates noise due to lead failure from ventricular tachyarrhythmias. We tested an algorithm that uses a measure of the ventricular intracardiac electrogram baseline to discriminate the sinus rhythm isoelectric line from the right ventricular coil-can (i.e., far-field) electrogram during oversensing of noise caused by a lead failure. The baseline measure was defined as the product of the sum (mV) and standard deviation (mV) of the voltage samples for a 188-ms window centered on each sensed electrogram. If the minimum baseline measure of the last 12 beats was <0.35 mV-mV, then the detected rhythm was considered noise due to a lead failure. The first ICD-detected episode of lead failure and inappropriate detection from 24 ICD patients with a pace/sense lead failure and all ventricular arrhythmias from 56 ICD patients without a lead failure were selected. The stored data were analyzed to determine the sensitivity and specificity of the algorithm to detect lead failures. The minimum baseline measure for the 24 lead failure episodes (0.28 +/- 0.34 mV-mV) was smaller than the 135 ventricular tachycardia (40.8 +/- 43.0 mV-mV, P <.0001) and 55 ventricular fibrillation episodes (19.1 +/- 22.8 mV-mV, P <.05). A minimum baseline <0.35 mV-mV threshold had a sensitivity of 83% (20/24) with a 100% (190/190) specificity. A baseline measure of the far-field electrogram had a high sensitivity and specificity to detect lead failure noise compared with ventricular tachycardia or fibrillation.

Shock anxiety among implantable cardioverter defibrillator recipients with recent tachyarrhythmia.

PubMed

Morken, Ingvild M; Isaksen, Kjetil; Karlsen, Bjørg; Norekvål, Tone M; Bru, Edvin; Larsen, Alf Inge

2012-11-01

Shock anxiety has been documented irrespective of shock exposure in implantable cardioverter defibrillator (ICD) recipients. The presence of tachyarrhythmia may lead to an anticipation of receiving a shock and thereby give rise to shock anxiety. The aims were to assess: (1) the level of shock anxiety in a sample of ICD recipients, (2) the relationship between such anxiety and shock exposure, and (3) the relationship between recent tachyarrhythmia and shock anxiety. ICD recipients (n = 167) completed the Florida Shock Anxiety Scale measure of shock anxiety. The recipients were divided into three groups: (1) Recipients with no documented tachyarrhythmia over the previous 12 months (n = 56), (2) recipients with documented tachyarrhythmia over the previous twelve months (n = 54), and (3) recipients with any history of shocks (n = 57). Of the recipients, 44% experienced some form of shock anxiety, whereas 15% reported general shock anxiety. Analyses of covariance revealed that recipients with recent tachyarrhythmia (F = 7.675 df = 9/100, P = 0.007) as well as recipients with a shock history (F = 9.976, df = 9/103, P = 0.002) reported higher levels of shock anxiety than recipients with no recent tachyarrhythmia. This study indicates that although a substantial proportion of the ICD recipients experienced some form of shock anxiety, only a relatively small proportion reported general shock anxiety. ICD recipients with recent tachyarrhythmia, in addition to recipients with shock history, appear to be at greater risk for development of shock anxiety. This implies that these recipients may profit from clinical-based strategies and interventions targeting shock anxiety. ©2012, The Authors. Journal compilation ©2012 Wiley Periodicals, Inc.

Gender, Racial, and Health Insurance Differences in the Trend of Implantable Cardioverter-Defibrillator (ICD) Utilization: A United States Experience Over the Last Decade.

PubMed

Patel, Nileshkumar J; Edla, Sushruth; Deshmukh, Abhishek; Nalluri, Nikhil; Patel, Nilay; Agnihotri, Kanishk; Patel, Achint; Savani, Chirag; Patel, Nish; Bhimani, Ronak; Thakkar, Badal; Arora, Shilpkumar; Asti, Deepak; Badheka, Apurva O; Parikh, Valay; Mitrani, Raul D; Noseworthy, Peter; Paydak, Hakan; Viles-Gonzalez, Juan; Friedman, Paul A; Kowalski, Marcin

2016-02-01

Prior studies have highlighted disparities in cardiac lifesaving procedure utilization, particularly among women and in minorities. Although there has been a significant increase in implantable cardioverter-defibrillator (ICD) insertion, socioeconomic disparities still exist in the trend of ICD utilization. With the use of the Nationwide Inpatient Sample from 2003 through 2011, we identified subjects with ICD insertion (procedure code 37.94) and cardiac resynchronization defibrillator (procedure code 00.50, 00.51) as codified by the International Classification of Diseases, Ninth Revision, Clinical Modification. Overall, 1 020 076 ICDs were implanted in the United States from 2003 to 2011. We observed an initial increase in ICD utilization by 51%, from 95 062 in 2003 to 143 262 in 2006, followed by a more recent decline. The majority of ICDs were implanted in men age ≥65 years. Implantation of ICDs was 2.5× more common in men than in women (402 per million vs 163 per million). Approximately 95% of the ICDs were implanted in insured patients, and 5% were used in the uninsured population. There has been a significant increase in ICD implantation in blacks, from 162 per million in 2003 to 291 per million in 2011. We found a significant difference in the volume of ICD implants between the insured and the uninsured patient populations. Racial disparities have narrowed significantly in comparison with those noted in earlier studies and are now more reflective of the population demographics at large. On the other hand, significant gender disparities continue to exist. © 2016 Wiley Periodicals, Inc.

The Role of Implantable Cardioverter Defibrillators in Patients Bridged to Transplantation with a Continuous Flow Left Ventricular Assist Device: A Propensity Score Matched Analysis

PubMed Central

Clerkin, Kevin J.; Topkara, Veli K.; Mancini, Donna M.; Yuzefpolskaya, Melana; Demmer, Ryan T.; Dizon, Jose M.; Takeda, Koji; Takayama, Hiroo; Naka, Yoshifumi; Colombo, Paolo C.; Garan, A. Reshad

2016-01-01

Background Implantable cardioverter defibrillators (ICD) provide a significant mortality benefit for appropriately selected patients with advanced heart failure. ICDs are associated with a mortality benefit when used in patients with a pulsatile left ventricular assist device (LVAD). However it is unclear whether patients with a continuous flow LVAD (CF-LVAD) derive the same benefit. This study sought to determine if the presence of an ICD provided a mortality benefit during CFLVAD support as a bridge to transplantation. Methods Patients were identified in the United Network for Organ Sharing (UNOS) registry that underwent LVAD implantation as bridge to transplantation from May 2004 and April 2014, with follow-up through June 2014. The primary outcome was freedom from death while on CF-LVAD support with adjustment for complications requiring UNOS listing status upgrade. Secondary endpoints included freedom from delisting while on CF-LVAD support and incidence of transplantation. Results 2,990 patients composed the study cohort and propensity score matching identified 1,012 patients with similar propensity scores. There was no difference in survival during device support between patients with and without an ICD (Hazard Ratio [HR] 1.20, 95% Confidence Interval [CI] 0.66-2.17, p=0.55). Adjusting for device complications requiring a UNOS listing status upgrade had minimal influence (HR 1.11, 95% CI 0.60-2.05, p=0.74). There was no increased risk of delisting due to being too sick for those with an ICD (HR 1.08, 95% CI 0.63-1.86, p=0.78). Likewise, the probability of transplantation was similar (HR 1.05, 95% CI 0.87-1.27, p=0.62). Conclusions Among patients bridged to transplantation with a CF-LVAD, the presence of an ICD did not reduce mortality. PMID:28089072

Inappropriate implantable cardioverter defibrillator shocks in fractured Sprint Fidelis leads associated with 'appropriate' interrogation.

PubMed

Farwell, David; Redpath, Calum; Birnie, David; Gollob, Michael; Lemery, Robert; Posan, Emoke; Green, Martin

2008-06-01

We present two patients with fractures within the pace-sense circuit of their Medtronic Sprint Fidelis leads who received inappropriate shocks from their Medtronic defibrillators during device interrogation. This was not simply a coincidence, but due to electromagnetic interference induced within the Sprint Fidelis lead by the device programmer during two-way communication with the defibrillator. Our subsequent investigations have uncovered at least two other similar incidents in Canada. We have also discovered that the Medtronic 'Auto-resume' feature may leave future patients uniquely vulnerable to such inappropriate shocks in the future.

Effects of an alert system on implantable cardioverter defibrillator-related anxiety: rationale, design, and endpoints of the PANORAMIC multicentre trial.

PubMed

Duru, Firat; Dorian, Paul; Favale, Stefano; Perings, Christian; Pedersen, Susanne S; Willems, Vincent

2010-05-01

Implantable cardioverter defibrillators (ICD) can prevent sudden cardiac death by delivering high-energy shocks in patients at risk of life-threatening ventricular tachyarrhythmias. Patients may be anxious about receiving inappropriate shocks in case of device or lead system malfunction, or about failing to receive needed therapy for the same reason. New devices include programmable vibrating patient notifiers (PN), which, by warning patients of a possible device dysfunction, might lower device-related anxiety. PAtient NOtifier feature for Reduction of Anxiety: a Multicentre ICD study (PANORAMIC) is a multicentre, randomized, clinical trial designed to examine the effects of the awareness of an active vibrating alert system on device-related anxiety. The trial will randomly assign 356 patients in a 1:1 design to a control group (PN OFF) vs. a treatment group (PN ON). Patients will be followed for 12 months, with visits scheduled at 6 and 12 months. During clinical follow-up visits, the ICD will be interrogated, and all patients will complete the Hospital Anxiety and Depression Scale and a device-related anxiety questionnaire. The sensitivity and specificity of PN, the effect of personality on anxiety, using the Type D scale (DS14), the number of delivered appropriate and inappropriate ICD therapies, changes in anxiety related to the delivery of appropriate or inappropriate shocks, crossovers from the assigned group, the number of hospitalizations, and the mortality rate will also be assessed. ClinicalTrials.gov Identifier: NCT00559559.

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.

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.

Effect of psycho-educational interventions on quality of life in patients with implantable cardioverter defibrillators: a meta-analysis of randomized controlled trials.

PubMed

Kao, Chi-Wen; Chen, Miao-Yi; Chen, Ting-Yu; Lin, Pai-Hui

2016-09-30

Implantable cardioverter defibrillators (ICD) were developed for primary and secondary prevention of sudden cardiac death. However, ICD recipients' mortality is significantly predicted by their quality of life (QOL). The aim of this meta-analysis was to evaluate the effects of psycho-educational interventions on QOL in patients with ICDs. We systematically searched PubMed, Medline, Cochrane Library, and CINAHL through April 2015 and references of relevant articles. Studies were reviewed if they met following criteria: (1) randomized controlled trial, (2) participants were adults with an ICD, and (3) data were sufficient to evaluate the effect of psychological or educational interventions on QOL measured by the SF-36 or SF-12. Studies were independently selected and their data were extracted by two reviewers. Study quality was evaluated using a modified Jadad scale. The meta-analysis was conducted using the Cochrane Collaboration's Review Manager Software Package (RevMan 5). Study heterogeneity was assessed by Q statistics and I 2 statistic. Depending on heterogeneity, data were pooled across trials using fixed-effect or random-effect modeling. Seven randomized controlled trials fulfilled the inclusion and exclusion criteria, and included 1017 participants. The psycho-educational interventions improved physical component summary (PCS) scores in the intervention groups more than in control groups (mean difference 2.08, 95 % CI 0.86 to 3.29, p < 0.001), but did not significantly affect mental component summary (MCS) scores (mean difference 0.84, 95 % CI -1.68 to 3.35, p = 0.52). Our meta-analysis demonstrates that psycho-educational interventions improved the physical component, but not the mental component of QOL in patients with ICDs.

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.

Battery longevity of implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators: technical, clinical and economic aspects. An expert review paper from EHRA.

PubMed

Boriani, Giuseppe; Merino, Josè; Wright, David J; Gadler, Fredrik; Schaer, Beat; Landolina, Maurizio

2018-05-10

In recent years an extension of devices longevity has been obtained for implantable cardioverter-defibrillators (ICDs), including ICDs for cardiac resynchronization therapy (CRT-D) through improved battery chemistry and device technology and this implies important clinical benefits (reduced need for device replacements and associated complications, particularly infections), as well as economic benefits, in line with patient preferences and needs. From a clinical point of view, the availability of this improvement in technology allows to better tune the choice of the device to be implanted, taking into account that the reasons supporting the value of an extended device longevity as a clinical priority may differ according to the clinical setting (purely electrical diseases or left ventricular dysfunction/heart failure, respectively). From an economic point of view, extension of device longevity may have an important impact in reducing long-term costs of device therapy, with substantial daily savings in favour of devices with extended longevity, up to 30%, depending on clinical scenarios. In studies based on projections, an extension of device longevity allowed to calculate that the cost per day of ICDs may be substantially reduced, and this allows to overcome the frequent perception of ICD and CRT-D devices as treatments with unaffordable costs and to overturn the misconception that up-front costs are the only metric with which to value device treatments. In view of its clinical and economic value, device longevity should be a determining factor in device choice by physicians and healthcare commissioners and should be appropriately considered and valued in comparative tenders.

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.

Refusing Implantable Cardioverter Defibrillator (ICD) Replacement in Elderly Persons-The Same as Giving Up Life: A Qualitative Study.

PubMed

Svanholm, Jette Rolf; Nielsen, Jens Cosedis; Mortensen, Peter; Christensen, Charlotte Fuglesang; Birkelund, Regner

2015-11-01

More than 20% of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices are implanted in the elderly population aged 80 years or older. In recent scientific literature it is suggested to consider termination of ICD therapy, rather than ICD replacement, in this patient group. The aim of this study was to explore the experiences of persons above 80 years of age concerning replacement of the ICD battery, and the shared communication and decision making with healthcare professionals. We performed a qualitative, explorative study, inspired by Ricoeur's narrative, with a phenomenological-hermeneutic approach, involving 11 ICD patients older than 80 years. The study period was 2011-2012. The meaning of the patients' experiences of living with an ICD was formulated into two themes: (1) "Feeling safe with the ICD" with the subthemes: "The ICD-a life keeper," "The battery level is important," "ICD shock-no problem." (2) "The physician is an authority" with the subthemes: "Being trustful," "Feeling fine knowing nothing," "Criminal act to deactivate the ICD." The elderly ICD recipients tended not to be aware of the option of declining replacement of their ICD. They tended to expect to have their ICD replaced and not to be involved actively in decision making concerning this. Healthcare professionals have an obligation to discuss options and ensure that every patient understands these. More research is needed to change practices and create more realistic, person-centered, ethically acceptable, and constructive healthcare for elderly persons with an ICD. © 2015 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.

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.

Design and rationale of the ANALYZE ST study: a prospective, nonrandomized, multicenter ST monitoring study to detect acute coronary syndrome events in implantable cardioverter-defibrillator patients.

PubMed

Gibson, C Michael; Krucoff, Mitchell; Kirtane, Ajay J; Rao, Sunil V; Mackall, Judith A; Matthews, Ray; Saba, Samir; Waksman, Ron; Holmes, David

2014-10-01

In the setting of ST-segment elevation myocardial infarction, timely restoration of normal blood flow is associated with improved myocardial salvage and survival. Despite improvements in door-to-needle and door-to-balloon times, there remains an unmet need with respect to improved symptom-to-door times. A prior report of an implanted device to monitor ST-segment deviation demonstrated very short times to reperfusion among patients with an acute coronary syndrome (ACS) with documented thrombotic occlusion. The goal of the ANALYZE ST study is to evaluate the safety and effectiveness of a novel ST-segment monitoring feature using an existing implantable cardioverter-defibrillator (ICD) among patients with known coronary artery disease. The ANALYZE ST study is a prospective, nonrandomized, multicenter, pivotal Investigational Device Exemption study enrolling 5,228 patients with newly implanted ICD systems for standard clinical indications who also have a documented history of coronary artery disease. Patients will be monitored for 48 months, during which effectiveness of the device for the purpose of early detection of cardiac injury will be evaluated by analyzing the sensitivity of the ST monitoring feature to identify clinical ACS events. In addition, the safety of the ST monitoring feature will be evaluated through the assessment of the percentage of patients for which monitoring produces a false-positive event over the course of 12 months. The ANALYZE ST trial is testing the hypothesis that the ST monitoring feature in the Fortify ST ICD system (St. Jude Medical, Inc., St. Paul, MN) (or other ICD systems with the ST monitoring feature) will accurately identify patients with clinical ACS events. Copyright © 2014 Mosby, Inc. All rights reserved.

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.

Cardiac sympathetic innervation assessed with (123)I-MIBG retains prognostic utility in diabetic patients with severe left ventricular dysfunction evaluated for primary prevention implantable cardioverter-defibrillator.

PubMed

García-González, P; Fabregat-Andrés, Ó; Cozar-Santiago, P; Sánchez-Jurado, R; Estornell-Erill, J; Valle-Muñoz, A; Quesada-Dorador, A; Payá-Serrano, R; Ferrer-Rebolleda, J; Ridocci-Soriano, F

2016-01-01

Scintigraphy with iodine-123-metaiodobenzylguanidine ((123)I-MIBG) is a non-invasive tool for the assessment of cardiac sympathetic innervation (CSI) that has proven to be an independent predictor of survival. Recent studies have shown that diabetic patients with heart failure (HF) have a higher deterioration in CSI. It is unknown if (123)I-MIBG has the same predictive value for diabetic and non-diabetic patients with advanced HF. An analysis is performed to determine whether CSI with (123)I-MIBG retains prognostic utility in diabetic patients with HF, evaluated for a primary prevention implantable cardioverter-defibrillator (ICD). Seventy-eight consecutive HF patients (48 diabetic) evaluated for primary prevention ICD implantation were prospectively enrolled and underwent (123)I-MIBG to assess CSI (heart-to-mediastinum ratio - HMR). A Cox proportional hazards multivariate analysis was used to determine the influence of (123)I-MIBG images for prediction of cardiac events in both diabetic and non-diabetic patients. The primary end-point was a composite of arrhythmic event, cardiac death, or admission due to HF. During a mean follow-up of 19.5 [9.3-29.3] months, the primary end-point occurred in 24 (31%) patients. Late HMR was significantly lower in diabetic patients (1.30 vs. 1.41, p=0.014). Late HMR≤1.30 was an independent predictor of cardiac events in diabetic (hazard ratio 4.53; p=0.012) and non-diabetic patients (hazard ratio 12.31; p=0.023). Diabetic patients with HF evaluated for primary prevention ICD show a higher deterioration in CSI than non-diabetics; nevertheless (123)I-MIBG imaging retained prognostic utility for both diabetic and non-diabetic patients. Copyright © 2015 Elsevier España, S.L.U. and SEMNIM. All rights reserved.

Relation between detection rate and inappropriate shocks in single versus dual chamber cardioverter-defibrillator – an analysis from the OPTION trial

PubMed Central

Kolb, Christof; Sturmer, Marcio; Babuty, Dominique; Sick, Peter; Davy, Jean Marc; Molon, Giulio; Schwab, Jörg Otto; Mantovani, Giuseppe; Wickliffe, Andrew; Lennerz, Carsten; Semmler, Verena; Siot, Pierre-Henri; Reif , Sebastian

2016-01-01

The programming of implantable cardioverter-defibrillators (ICDs) influences inappropriate shock rates. The aim of the study is to analyse rates of patients with appropriate and inappropriate shocks according to detection zones in the OPTION trial. All patients received dual chamber (DC) ICDs randomly assigned to be programmed either to single chamber (SC) or to DC settings including PARAD+ algorithm. In a post-hoc analysis, rates of patients with inappropriate and appropriate shocks were calculated for shocks triggered at heart rates ≥170 bpm (ventricular tachycardia zone) and at rates ≥200 bpm (ventricular fibrillation zone). In the SC group, higher rates of patients with total and inappropriate shocks were delivered at heart rates ≥170 bpm than at rates ≥200 bpm (total shocks: 21.1% vs. 16.6%; p = 0.002; inappropriate shocks: 7.6% vs. 4.5%, p = 0.016; appropriate shocks: 15.2% vs. 13.5%; p = n.s.). No such differences were observed in the DC group (total shocks: 14.3% vs. 12.6%; p = n.s.; inappropriate shocks: 3.9% vs. 3.6%; p = n.s.; appropriate shocks: 12.2% vs. 10.4%; p = n.s.). The higher frequency of patients with total shocks with SC settings than with DC settings that benefit from PARAD+ was driven by a higher percentage of patients with inappropriate shocks in the VT zone (170–200 bpm) in the SC population. PMID:26892534

An abdominal active can defibrillator may facilitate a successful generator change when a lead failure is present.

PubMed

Solomon, A J; Moubarak, J B; Drood, J M; Tracy, C M; Karasik, P E

1999-10-01

Defibrillator generator changes are frequently performed on patients with an implantable cardioverter defibrillator in an abdominal pocket. These patients usually have epicardial patches or older endocardial lead systems. At the time of a defibrillator generator change defibrillation may be unsuccessful as a result of lead failure. We tested the hypothesis that an active can defibrillator implanted in the abdominal pocket could replace a non-functioning endocardial lead or epicardial patch. An abdominal defibrillator generator change was performed in 10 patients, (mean age = 67 +/- 13 years, nine men). Initially, a defibrillation threshold (DFT) was obtained using a passive defibrillator and the chronic endocardial or epicardial lead system. DFTs were then performed using an active can emulator and one chronic lead to simulate endocardial or epicardial lead failure. We tested 30 lead configurations (nine endocardial and 21 epicardial). Although a DFT of 7.3 +/- 4.2 joules was obtained with the intact chronic lead system, the active can emulator and one endocardial or epicardial lead still yielded an acceptable DFT of 19.9 +/- 6.1 joules. In addition, a successful implant (DFT < or = 24 joules) could have been accomplished in 28 of 30 (93%) lead configurations. An active can defibrillator in an abdominal pocket may allow for a successful generator change in patients with defibrillator lead malfunction. This would be simpler than abandoning the abdominal implant and moving to a new pectoral device and lead or tunnelling a new endocardial electrode. However, loss of defibrillation capability with a particular complex lead may be a warning of impending loss of other functions (eg. sensing and/or pacing).

Implantable Cardioverter-Defibrillators in Patients With a Continuous-Flow Left Ventricular Assist Device: An Analysis of the INTERMACS Registry.

PubMed

Clerkin, Kevin J; Topkara, Veli K; Demmer, Ryan T; Dizon, Jose M; Yuzefpolskaya, Melana; Fried, Justin A; Mai, Xingchen; Mancini, Donna M; Takeda, Koji; Takayama, Hiroo; Naka, Yoshifumi; Colombo, Paolo C; Garan, A Reshad

2017-12-01

This study sought to determine if the presence of implantable cardioverter-defibrillators (ICD) provided a mortality benefit during continuous-flow left ventricular assist device (LVAD) support. An ICD decreases mortality in selected patients with advanced heart failure and have been associated with reduced mortality in patients with pulsatile LVAD. However, it is unclear whether that benefit extends to patients with a contemporary continuous-flow LVAD. Propensity score matching was used to generate a cohort of patients with similar baseline characteristics. The primary outcome was freedom from death during LVAD support. Secondary endpoints included freedom from unexpected death, likelihood of transplantation and recovery, and adverse events. Among 16,384 eligible patients in the Interagency Registry for Mechanically Assisted Circulatory Support registry, 2,209 patients with an ICD and 2,209 patients without one had similar propensity scores and were included. The presence of an ICD was associated with an increased mortality risk (hazard ratio: 1.20; 95% confidence interval [CI]: 1.04 to 1.39; p = 0.013) and an increased risk of unexpected death during device support (HR: 1.33; 95% CI: 1.03 to 1.71; p = 0.03). Patients with an ICD were more likely to undergo transplantation (HR: 1.16; 95% CI: 0.99 to 1.35; p = 0.06) and less likely to have LVAD explant for recovery (HR: 0.53, 95% CI: 0.29 to 0.98; p = 0.04). Patients with an ICD had a higher rate of treated ventricular arrhythmias (rate ratio: 1.27; 95% CI: 1.10 to 1.48; p = 0.001) and rehospitalization (rate ratio: 1.08; 95% CI: 1.04 to 1.12; p < 0.0001), but rates of hemorrhagic stroke were similar (rate ratio: 1.01; 95% CI: 0.81 to 1.26; p = 0.98). Among patients with a continuous flow LVAD, the presence of an ICD was not associated with reduced mortality. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Sex is associated with differences in individual trajectories of change in social health after implantable cardioverter-defibrillator.

PubMed

Lauck, Sandra B; Sawatzky, Richard; Johnson, Joy L; Humphries, Karin; Bennett, Matthew T; Chakrabarti, Santabhanu; Kerr, Charles R; Tung, Stanley; Yeung-Lai-Wah, John A; Ratner, Pamela A

2015-03-01

Social health is a dimension of quality of life, and refers to people's involvement in, and satisfaction with social roles, responsibilities, and activities. The implantable cardioverter-defibrillator is associated with changes in overall quality of life, but little is known about sex differences in individual trajectories of change in social health. We prospectively measured changes in 3 subscales of the SF-36v2 generic health questionnaire (role physical, role emotional, and social functioning), 2 Patient-Reported Outcomes Measurement Information System short forms (satisfaction with participation in social roles and satisfaction with participation in discretionary social activities), and the Florida Patient Acceptance Survey before and at 1, 2, and 6 months after implantation. Individual growth models of temporal change were estimated. The scores of the 6 indicators improved with time. The unconditional model demonstrated significant (fixed effects: P<0.05; covariance parameters: P<0.10) residual variability in the individual trajectories. In the conditional model, men and women differed significantly in their rates of change in the scores of 3 of the 6 measures. Although men's mean scores exceeded women's mean scores on all indicators at baseline (range of relative mean difference: 11.0% to 17.8%), the rate of women's change resulted in a reversal in relative standing at 6 months after implantation, with the mean scores of women exceeding the men's by 4.5% to 5.6%. Men and women differed in their trajectories of change in social health, both in terms of their starting points (ie, baseline scores) and their rates of change. © 2015 American Heart Association, Inc.

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.

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.

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.

Atrial therapies reduce atrial arrhythmia burden in defibrillator patients.

PubMed

Friedman, P A; Dijkman, B; Warman, E N; Xia, H A; Mehra, R; Stanton, M S; Hammill, S C

2001-08-28

Approximately 25% of patients who receive an implantable cardioverter-defibrillator (ICD) to treat ventricular tachyarrhythmias have documented atrial tachyarrhythmias before implantation. This study assessed the ability of device-based prevention and termination therapies to reduce the burden of spontaneous atrial tachyarrhythmias. Patients with a standard indication for the implantation of an ICD and 2 episodes of atrial tachyarrhythmias in the preceding year received a dual-chamber ICD (Medtronic 7250 Jewel AF) that uses pacing and shock therapies for prevention and/or termination of atrial tachyarrhythmias. In a multicenter trial, patients were randomized to 3-month periods with atrial therapies "on" or "off" and subsequently crossed over. Analysis was performed on the 52 of 269 patients who had episodes of atrial tachyarrhythmia and had >/=30 days of follow-up with atrial therapies on and off. The atrial therapies resulted in a reduction of atrial tachyarrhythmia burden from a mean of 58.5 to 7.8 h/mo. A paired analysis (Wilcoxon signed-rank test) showed that the median difference in burden (1.1 h/mo) was highly significant (P=0.007). When the subgroup of 41 patients treated only with atrial pacing therapies was analyzed, the reduction in burden persisted (P=0.01). In this study, patients with a standard ICD indication and atrial tachyarrhythmias had a significant reduction in atrial tachyarrhythmia burden with use of atrial pacing and shock therapies.

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

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

Cardiac e-learning: Development of a web-based implantable cardioverter defibrillator educational system.

PubMed

Hickey, Kathleen T; Johnson, Mary P; Biviano, Angelo; Aboelela, Sally; Thomas, Tami; Bakken, Suzanne; Garan, Hasan; Zimmerman, John L; Whang, William

2011-04-01

The objective of this study was to design a Web-based implantable cardioverter defibrillator (ICD) module that would allow greater access to learning which could occur at an individual's convenience outside the fast-paced clinical environment. A Web-based ICD software educational program was developed to provide general knowledge of the function of the ICD and the interpretation of the stored electrocardiograms. This learning tool could be accessed at any time via the Columbia University Internet server, using a unique, password protected login. A series of basic and advanced ICD terms were presented using actual ICD screenshots and videos that simulated scenarios the practitioner would most commonly encounter in the fast-paced clinical setting. To determine the usefulness of the site and improve the module, practitioners were asked to complete a brief (less than 5 min) online survey at the end of the module. Twenty-six practitioners have logged into our Web site: 20 nurses/nurse practitioners, four cardiac fellows, and two other practitioners. The majority of respondents rated the program as easy to use and useful. The success of this module has led to it becoming part of the training for student nurse practitioners before a clinical electrophysiology rotation, and the module is accessed by our cardiac entry level fellows before a rotation in the intensive care unit or electrophysiology service. Remote electronic arrhythmia learning is a successful example of the melding of technology and education to enhance clinical learning.

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.

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.

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

PubMed

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

2016-09-01

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

Entropy of cardiac repolarization predicts ventricular arrhythmias and mortality in patients receiving an implantable cardioverter-defibrillator for primary prevention of sudden death.

PubMed

DeMazumder, Deeptankar; Limpitikul, Worawan B; Dorante, Miguel; Dey, Swati; Mukhopadhyay, Bhasha; Zhang, Yiyi; Moorman, J Randall; Cheng, Alan; Berger, Ronald D; Guallar, Eliseo; Jones, Steven R; Tomaselli, Gordon F

2016-12-01

The need for a readily available, inexpensive, non-invasive method for improved risk stratification of heart failure (HF) patients is paramount. Prior studies have proposed that distinct fluctuation patterns underlying the variability of physiological signals have unique prognostic value. We tested this hypothesis in an extensively phenotyped cohort of HF patients using EntropyX QT , a novel non-linear measure of cardiac repolarization dynamics. In a prospective, multicentre, observational study of 852 patients in sinus rhythm undergoing clinically indicated primary prevention implantable cardioverter-defibrillator (ICD) implantation (2003-10), exposures included demographics, history, physical examination, medications, laboratory results, serum biomarkers, ejection fraction, conventional electrocardiographic (ECG) analyses of heart rate and QT variability, and EntropyX QT . The primary outcome was first 'appropriate' ICD shock for ventricular arrhythmias. The secondary outcome was composite events (appropriate ICD shock and all-cause mortality). After exclusions, the cohort (n = 816) had a mean age of 60 ± 13 years, 28% women, 36% African Americans, 56% ischaemic cardiomyopathy, and 29 ± 16% Seattle HF risk score (SHFS) 5-year predicted mortality. Over 45 ± 24 months, there were 134 appropriate shocks and 166 deaths. After adjusting for 30 exposures, the hazard ratios (comparing the 5th to 1st quintile of EntropyX QT ) for primary and secondary outcomes were 3.29 (95% CI 1.74-6.21) and 2.28 (1.53-3.41), respectively. Addition of EntropyX QT to a model comprised of the exposures or SHFS significantly increased net reclassification and the ROC curve area. EntropyX QT measured during ICD implantation strongly and independently predicts appropriate shock and all-cause mortality over follow-up. EntropyX QT complements conventional risk predictors and has the potential for broad clinical application. Published on behalf of the European Society of Cardiology. All

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.

Novel mechanism of premature battery failure due to lithium cluster formation in implantable cardioverter-defibrillators.

PubMed

Pokorney, Sean D; Greenfield, Ruth Ann; Atwater, Brett D; Daubert, James P; Piccini, Jonathan P

2014-12-01

Battery failure is an uncommon complication of implantable cardioverter-defibrillators (ICDs), but unanticipated battery depletion can have life-threatening consequences. The purpose of this study was to describe the prevalence of a novel mechanism of battery failure in St. Jude Medical Fortify and Unify ICDs. Cases of premature Fortify battery failure from a single center are reported. A search (January 1, 2010 through November 30, 2013) for Fortify and Unify premature batter failure was conducted of the Food and Drug Administration's Manufacturer and User Facility Device Experience Database (MAUDE). These findings were supplemented with information provided by St. Jude Medical. Premature battery failure for 2 Fortify ICDs in our practice were attributed to the presence of lithium clusters near the cathode, causing a short circuit and high current drain. The prevalence of this mechanism of premature battery failure was 0.6% in our practice. A MAUDE search identified 39 cases of Fortify (30) and Unify (9) premature battery depletion confirmed by the manufacturer, representing a 0.03% prevalence. Four additional Fortify and 2 Unify cases were identified in MAUDE as suspected premature battery depletion, but in these cases the pulse generator was not returned to the manufacturer for evaluation. St. Jude Medical identified 10 cases of premature battery failure due to lithium clusters in Fortify devices (9) and Unify devices (1), representing a 0.004% prevalence. The deposition of lithium clusters near the cathode is a novel mechanism of premature battery failure. The prevalence of this problem is unknown. Providers should be aware of this mechanism for patient management. Copyright © 2014 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Economic impact of longer battery life of cardiac resynchronization therapy defibrillators in Sweden.

PubMed

Gadler, Fredrik; Ding, Yao; Verin, Nathalie; Bergius, Martin; Miller, Jeffrey D; Lenhart, Gregory M; Russell, Mason W

2016-01-01

The objective of this study was to quantify the impact that longer battery life of cardiac resynchronization therapy defibrillator (CRT-D) devices has on reducing the number of device replacements and associated costs of these replacements from a Swedish health care system perspective. An economic model based on real-world published data was developed to estimate cost savings and avoided device replacements for CRT-Ds with longer battery life compared with devices with industry-standard battery life expectancy. Base-case comparisons were performed among CRT-Ds of three manufacturers - Boston Scientific Corporation, St. Jude Medical, and Medtronic - over a 6-year time horizon, as per the available clinical data. As a sensitivity analysis, we evaluated CRT-Ds as well as single-chamber implantable cardioverter defibrillator (ICD-VR) and dual-chamber implantable cardioverter defibrillator (ICD-DR) devices over a longer 10-year period. All costs were in 2015 Swedish Krona (SEK) discounted at 3% per annum. Base-case analysis results show that up to 603 replacements and up to SEK 60.4 million cumulative-associated costs could be avoided over 6 years by using devices with extended battery life. The pattern of savings over time suggests that savings are modest initially but increase rapidly beginning in the third year of follow-up with each year's cumulative savings two to three times the previous year. Evaluating CRT-D, ICD-VR, and ICD-DR devices together over a longer 10-year period, the sensitivity analysis showed 2,820 fewer replacement procedures and associated cost savings of SEK 249.3 million for all defibrillators with extended battery life. Extended battery life is likely to reduce device replacements and associated complications and costs, which may result in important cost savings and a more efficient use of health care resources as well as a better quality of life for heart failure patients in Sweden.

Is the coexistence of sustained ST-segment elevation and abnormal Q waves a risk factor for electrical storm in implanted cardioverter defibrillator patients with structural heart diseases?

PubMed

Furushima, Hiroshi; Chinushi, Masaomi; Iijima, Kenichi; Hasegawa, Kanae; Sato, Akinori; Izumi, Daisuke; Watanabe, Hiroshi; Aizawa, Yoshifusa

2012-05-01

The aim of this study was to determine whether or not the coexistence of sustained ST-segment elevation and abnormal Q waves (STe-Q) could be a risk factor for electrical storm (ES) in implanted cardioverter defibrillator (ICD) patients with structural heart diseases. In all, 156 consecutive patients received ICD therapy for secondary prevention of sudden cardiac death and/or sustained ventricular tachyarrhythmias were included. Electrical storm was defined as ≥3 separate episodes of ventricular tachycardia (VT) and/or ventricular fibrillation (VF) terminated by ICD therapies within 24 h. During a mean follow-up of 1825 ± 1188 days, 42 (26.9%) patients experienced ES, of whom 12 had coronary artery disease, 15 had idiopathic dilated cardiomyopathy, 6 had hypertrophic cardiomyopathy, 4 had arrhythmogenic right ventricular cardiomyopathy, 4 had cardiac sarcoidosis, and 1 had valvular heart disease. Sustained ST-segment elevation and abnormal Q waves in ≥2 leads on the 12-lead electrocardiography was observed in 33 (21%) patients. On the Kaplan-Meier analysis, patients with STe-Q had a markedly higher risk of ES than those without STe-Q (P< 0.0001). The multivariate Cox proportional hazards regression model indicated that STe-Q and left ventricular ejection fraction (LVEF) (<30%) were independent risk factors associated with the recurrence of VT/VF (STe-Q: HR 1.962, 95% CI 1.24-3.12, P= 0.004; LVEF: HR 1.860, 95% CI 1.20-2.89, P= 0.006), and STe-Q was an independent risk factor associated with ES (HR 4.955, 95% CI 2.69-9.13, P< 0.0001). Sustained ST-segment elevation and abnormal Q waves could be a risk factor of not only recurrent VT/VF but also ES in patients with structural heart diseases.

Reticular telangiectatic erythema: case report and literature review

PubMed Central

Beutler, Bryce D.; Cohen, Philip R.

2015-01-01

Background: Reticular telangiectatic erythema is a benign cutaneous reaction that may occur in patients who have received a subcutaneous implantable cardioverter-defibrillator. Reticular telangiectatic erythema is characterized by asymptomatic telangiectasias, blanchable erythematous patches, or both overlying and/or adjacent to the subcutaneous implantable cardioverter-defibrillator. Purpose: We describe a man who developed reticular telangiectatic erythema after receiving a subcutaneous implantable cardioverter-defibrillator and review the salient features of this condition. We also summarize the conditions that can mimic reticular telangiectatic erythema. Materials and methods: The features of a man with reticular telangiectatic erythema are presented and the literature on reticular telangiectatic erythema is reviewed. Results: Our patient developed reticular telangiectatic erythema within one month of subcutaneous implantable cardioverter-defibrillator insertion. The subcutaneous manifestations were asymptomatic. The patient concurred to have periodic clinical follow up and his condition will be monitored for any changes. Conclusion: Reticular telangiectatic erythema is a benign condition characterized by the development of erythema, telangiectasia, or both following insertion of a subcutaneous implantable cardioverter-defibrillator. Other subcutaneous implantable cardioverter-defibrillator-related side effects, such as pressure dermatitis and contact dermatitis, can mimic the condition. Reticular telangiectatic erythema can also be observed following insertion of other devices or, rarely, in the absence of inserted devices. Local microcirculatory changes and subcutaneous implantable cardioverter-defibrillator-related obstruction of blood flow have been suggested as possible mechanisms of pathogenesis. The diagnosis can usually be established by clinical presentation. Therefore, patch testing can usually be omitted. Reticular telangiectatic erythema is

Reticular telangiectatic erythema: case report and literature review.

PubMed

Beutler, Bryce D; Cohen, Philip R

2015-01-01

Reticular telangiectatic erythema is a benign cutaneous reaction that may occur in patients who have received a subcutaneous implantable cardioverter-defibrillator. Reticular telangiectatic erythema is characterized by asymptomatic telangiectasias, blanchable erythematous patches, or both overlying and/or adjacent to the subcutaneous implantable cardioverter-defibrillator. We describe a man who developed reticular telangiectatic erythema after receiving a subcutaneous implantable cardioverter-defibrillator and review the salient features of this condition. We also summarize the conditions that can mimic reticular telangiectatic erythema. The features of a man with reticular telangiectatic erythema are presented and the literature on reticular telangiectatic erythema is reviewed. Our patient developed reticular telangiectatic erythema within one month of subcutaneous implantable cardioverter-defibrillator insertion. The subcutaneous manifestations were asymptomatic. The patient concurred to have periodic clinical follow up and his condition will be monitored for any changes. Reticular telangiectatic erythema is a benign condition characterized by the development of erythema, telangiectasia, or both following insertion of a subcutaneous implantable cardioverter-defibrillator. Other subcutaneous implantable cardioverter-defibrillator-related side effects, such as pressure dermatitis and contact dermatitis, can mimic the condition. Reticular telangiectatic erythema can also be observed following insertion of other devices or, rarely, in the absence of inserted devices. Local microcirculatory changes and subcutaneous implantable cardioverter-defibrillator-related obstruction of blood flow have been suggested as possible mechanisms of pathogenesis. The diagnosis can usually be established by clinical presentation. Therefore, patch testing can usually be omitted. Reticular telangiectatic erythema is typically asymptomatic and thus removal of the device is not required.

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

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.

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.

Potential role of antitachycardia pacing alerts for the reduction of emergency presentations following shocks in patients with implantable cardioverter-defibrillators: implications for the implementation of remote monitoring.

PubMed

Boulé, Stéphane; Ninni, Sandro; Finat, Loïc; Botcherby, Edward J; Kouakam, Claude; Klug, Didier; Marquié, Christelle; Brigadeau, François; Lacroix, Dominique; Kacet, Salem; Guédon-Moreau, Laurence

2016-12-01

Despite increased use of remote monitoring (RM) to follow up implantable cardioverter-defibrillator (ICD) recipients, many patients still receive ICD shocks in the community and present to the emergency department. Our aim was to identify the best predictors of impending shock delivery that can be measured with an ICD and to identify the most appropriate activities to alert physicians to during RM follow-up. All patients presenting to our institution for ICD shock, from November 2011 to November 2014, were enrolled in this prospective study. Patient characteristics, investigation results, and details of electrical activities from ICD interrogation were recorded at presentation. Presentations were classified as potentially avoidable if activities from a list of set criteria were apparent more than 48 h before index shock. Univariate and multivariate analyses were then used to identify predictors of potentially avoidable shocks. In total, 109 emergency presentations were recorded in 90 patients (male: 85%; 57 ± 16 years; ischaemic cardiomyopathy: 49%; LVEF: 34 ± 13%; electrical storm: 40%), of which 26 (24%) were potentially avoidable. Antitachycardia pacing (ATP) episodes were the most important predictor of impending shock. Potentially avoidable shocks were preceded by more episodes of ATP than unavoidable shocks (13 [3-67] vs. 3 [0-10]; P < 0.001). Patients followed up with RM systems configured to generate alerts following ATP delivery experienced significantly less ICD shocks (24 vs. 16%, P < 0.01). Remote monitoring systems that generate alerts following ATP delivery could reduce emergency presentations for ICD shock by 24%, as ATP is a key predictor of impending shock delivery. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

Detection of atrial fibrillation and flutter by a dual-chamber implantable cardioverter-defibrillator. For the Worldwide Jewel AF Investigators.

PubMed

Swerdlow, C D; Schsls, W; Dijkman, B; Jung, W; Sheth, N V; Olson, W H; Gunderson, B D

2000-02-29

To distinguish prolonged episodes of atrial fibrillation (AF) that require cardioversion from self-terminating episodes that do not, an atrial implantable cardioverter-defibrillator (ICD) must be able to detect AF continuously for extended periods. The ICD should discriminate between atrial tachycardia/flutter (AT), which may be terminated by antitachycardia pacing, and AF, which requires cardioversion. We studied 80 patients with AT/AF and ventricular arrhythmias who were treated with a new atrial/dual-chamber ICD. During a follow-up period lasting 6+/-2 months, we validated spontaneous, device-defined AT/AF episodes by stored electrograms in all patients. In 58 patients, we performed 80 Holter recordings with telemetered atrial electrograms, both to validate the continuous detection of AT/AF and to determine the sensitivity of the detection of AT/AF. Detection was appropriate in 98% of 132 AF episodes and 88% of 190 AT episodes (98% of 128 AT episodes with an atrial cycle length <300 ms). Intermittent sensing of far-field R waves during sinus tachycardia caused 27 inappropriate AT/AF detections; these detections lasted 2.6+/-2.0 minutes. AT/AF was detected continuously in 27 of 28 patients who had spontaneous episodes of AT/AF (96%). The device memory recorded 90 appropriate AT/AF episodes lasting >1 hour, for a total of 2697 hours of continuous detection of AT/AF. During Holter monitoring, the sensitivity of the detection of AT/AF (116 hours) was 100%; the specificity of the detection of non-AT/AF rhythms (1290 hours) was 99.99%. Of 166 appropriate episodes detected as AT, 45% were terminated by antitachycardia pacing. A new ICD detects AT/AF accurately and continuously. Therapy may be programmed for long-duration AT/AF, with a low risk of underdetection. Discrimination of AT from AF permits successful pacing therapy for a significant fraction of AT.

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.

Impact of immortal person-time and time scale in comparative effectiveness research for medical devices: a case for implantable cardioverter-defibrillators.

PubMed

Mi, Xiaojuan; Hammill, Bradley G; Curtis, Lesley H; Greiner, Melissa A; Setoguchi, Soko

2013-08-01

To assess the extent of immortal time bias in estimating the clinical effectiveness of implantable cardioverter-defibrillators (ICDs) and the impact of methods of handling immortal time bias. Retrospective population-based cohort study of patients with heart failure in a national registry linked to Medicare claims (2003-2008). We compared three methods of handling immortal time bias, namely the Mantel-Byar (or time-dependent exposure assignment), the landmark, and the exclusion methods. Of the 5,226 study patients, 1,274 (24.4%) received ICD therapy. Total person-years in the Mantel-Byar method were 2,639, or 490 more than that in the exclusion method, reflecting potential immortal time in the study. The exclusion method yielded a hazard ratio of 0.71 (95% confidence interval [CI]: 0.63-0.80), which was 16% lower than the Mantel-Byar method (0.84; 95% CI: 0.75-0.95). The 120-day landmark method yielded similar results to those produced by the Mantel-Byar method (0.82; 95% CI: 0.72-0.95). Immortal time bias was detected in the ICD clinical effectiveness study, which might have led to substantial bias overestimating the treatment effect if handled by exclusion. When an appropriate landmark was selected, that method yielded similar hazard ratios to those obtained by the Mantel-Byar method, supporting the validity of the landmark method. Copyright © 2013 Elsevier Inc. All rights reserved.

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

Reduced appropriate implantable cardioverter-defibrillator therapy after cardiac resynchronization therapy-induced left ventricular function recovery: a meta-analysis and systematic review.

PubMed

Chatterjee, Neal A; Roka, Attila; Lubitz, Steven A; Gold, Michael R; Daubert, Claude; Linde, Cecilia; Steffel, Jan; Singh, Jagmeet P; Mela, Theofanie

2015-11-01

For patients undergoing cardiac resynchronization therapy (CRT) with implantable cardioverter-defibrillator (ICD; CRT-D), the effect of an improvement in left ventricular ejection fraction (LVEF) on appropriate ICD therapy may have significant implications regarding management at the time of ICD generator replacement. We conducted a meta-analysis to determine the effect of LVEF recovery following CRT on the incidence of appropriate ICD therapy. A search of multiple electronic databases identified 709 reports, of which 6 retrospective cohort studies were included (n = 1740). In patients with post-CRT LVEF ≥35% (study n = 4), the pooled estimated rate of ICD therapy (5.5/100 person-years) was significantly lower than patients with post-CRT LVEF <35% [incidence rate difference (IRD): -6.5/100 person-years, 95% confidence interval (95% CI): -8.8 to -4.2, P < 0.001]. Similarly, patients with post-CRT LVEF ≥45% (study n = 4) demonstrated lower estimated rates of ICD therapy (2.3/100 person-years) compared with patients without such recovery (IRD: -5.8/100 person-years, 95% CI: -7.6 to -4.0, P < 0.001). Restricting analysis to studies discounting ICD therapies during LVEF recovery (study n = 3), patients with LVEF recovery (≥35 or ≥45%) had significantly lower rates of ICD therapy compared with patients without such recovery (P for both <0.001). Patients with primary prevention indication for ICD, regardless of LVEF recovery definition, had very low rates of ICD therapy (0.4 to 0.8/100-person years). Recovery of LVEF post-CRT is associated with significantly reduced appropriate ICD therapy. Patients with improvement of LVEF ≥45% and those with primary prevention indication for ICD appear to be at lowest risk. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

[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.

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.

Sex and Race/Ethnicity Differences in Implantable Cardioverter-Defibrillator Counseling and Use Among Patients Hospitalized With Heart Failure: Findings from the Get With The Guidelines-Heart Failure Program.

PubMed

Hess, Paul L; Hernandez, Adrian F; Bhatt, Deepak L; Hellkamp, Anne S; Yancy, Clyde W; Schwamm, Lee H; Peterson, Eric D; Schulte, Phillip J; Fonarow, Gregg C; Al-Khatib, Sana M

2016-08-16

Previous studies have found that women and black patients eligible for a primary prevention implantable cardioverter-defibrillator (ICD) are less likely than men or white patients to receive one. We performed an observational analysis of the Get With The Guidelines-Heart Failure Program from January 1, 2011, to March 21, 2014. Patients admitted with heart failure and an ejection fraction ≤35% without an ICD were included. Rates of ICD counseling among eligible patients and ICD receipt among counseled patients were examined by sex and race/ethnicity. Among 21 059 patients from 236 sites, 4755 (22.6%) received predischarge ICD counseling. Women were counseled less frequently than men (19.3% versus 24.6%, P<0.001, adjusted odds ratio [OR], 0.84; 95% confidence interval [CI], 0.78-0.91). Racial and ethnic minorities were less likely to receive counseling than white patients (black 22.6%, Hispanic 18.6%, other race/ethnic group 14.4% versus white 24.3%, P<0.001 for each): adjusted OR versus white, 0.69; 95% CI, 0.63 to 0.76 for black patients; adjusted OR, 0.62; 95% CI, 0.55 to 0.70 for Hispanic patients; adjusted OR, 0.53; 95% CI, 0.43 to 0.65 for other patients. Among the 4755 counseled patients, 2977 (62.6%) received an ICD or had one planned for placement after hospital stay. Among those counseled, women and men were similarly likely to receive an ICD (adjusted OR, 1.13; 95% CI, 0.99-1.29). However, black (adjusted OR, 0.70; 95% CI, 0.56-0.88) and Hispanic patients (adjusted OR, 0.68; 95% CI, 0.46-1.01) were less likely to receive an ICD. Up to 4 of 5 hospitalized patients with heart failure eligible for ICD counseling did not receive it, particularly women and minority patients. Among counseled patients, ICD use differences by race and ethnicity persisted. © 2016 American Heart Association, Inc.

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.

Posttraumatic stress and quality of life with the totally subcutaneous compared to conventional cardioverter-defibrillator systems.

PubMed

Köbe, Julia; Hucklenbroich, Katharina; Geisendörfer, Nils; Bettin, Markus; Frommeyer, Gerrit; Reinke, Florian; Dechering, Dirk; Burgmer, Markus; Eckardt, Lars

2017-05-01

For prevention of sudden cardiac death, the transvenously implantable cardioverter-defibrillator therapy (tv-ICD) is well accepted. The subcutaneous system (S-ICD ® ) is promising in terms of reducing ICD complications. Nevertheless, the impact of the novel generator position on patients' quality of life (QoL) is yet unknown. This study aimed at comparing QoL and posttraumatic stress with both systems. 60 S-ICD ® and 60 case-controlled tv single-chamber ICD patients were asked to respond to three standardized questionnaires. PDS [screening for posttraumatic stress disorders (PTSD)] and PHQ-D (detection of the most predominant psychological disorders) were used to screen for potential mental comorbidities. The SF-12 questionnaire was used to evaluate physical and mental well-being. Groups were compared in terms of QoL and PTSD. n = 42 (70%) pairs were analyzed (n = 30 male, mean age 44.6 ± 12.2 years). Prior appropriate (p = 0.06) or inappropriate episodes (p = 0.24), ejection fraction (p = 0.28), or underlying cardiac disease did not differ significantly between groups. PDS revealed a PTSD in n = 6 tv-ICD and n = 6 S-ICD ® patients (14.3%) equally. In the PHQ-D questionnaire, n = 4 tv-ICD and n = 2 S-ICD ® patients fulfilled criteria for a major depression (p = 0.68). Panic disorders (n = 2 tv, n = 0 S-ICD ® , p = 0.5), and anxiety disorders (n = 3 S-ICD ® , n = 0 tv-ICD, p = 0.24) did not differ between groups. The physical well-being score was 39.9 ± 12.5 in patients with a tv-ICD compared to 46.6 ± 9.9 in S-ICD ® patients (p = 0.01). The mental well-being score was comparable in both groups (tv-ICD 51.8 ± 10.8 vs. S-ICD ® 51.9 ± 10.4, p = 0.95). Our case-control study revealed equal or even better physical well-being of patients with the S-ICD ® . PTSD occurred in almost 15% of ICD patients irrespective of the type of system.

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.

Patient ECG recording control for an automatic implantable defibrillator

NASA Technical Reports Server (NTRS)

Fountain, Glen H. (Inventor); Lee, Jr., David G. (Inventor); Kitchin, David A. (Inventor)

1986-01-01

An implantable automatic defibrillator includes sensors which are placed on or near the patient's heart to detect electrical signals indicative of the physiology of the heart. The signals are digitally converted and stored into a FIFO region of a RAM by operation of a direct memory access (DMA) controller. The DMA controller operates transparently with respect to the microprocessor which is part of the defibrillator. The implantable defibrillator includes a telemetry communications circuit for sending data outbound from the defibrillator to an external device (either a patient controller or a physician's console or other) and a receiver for sensing at least an externally generated patient ECG recording command signal. The patient recording command signal is generated by the hand held patient controller. Upon detection of the patient ECG recording command, DMA copies the contents of the FIFO into a specific region of the RAM.

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.

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.

Differentiation of ventricular and supraventricular tachycardias based on the analysis of the first postpacing interval after sequential anti-tachycardia pacing in implantable cardioverter-defibrillator patients.

PubMed

Arenal, Angel; Ortiz, Mercedes; Peinado, Rafael; Merino, Jose L; Quesada, Aurelio; Atienza, Felipe; Alberola, Arcadio García; Ormaetxe, Jose; Castellanos, Eduardo; Rodriguez, Juan C; Pérez, Nicasio; García, Javier; Boluda, Luis; del Prado, Mario; Artés, Antonio

2007-03-01

Current discrimination algorithms do not completely avoid inappropriate tachycardia detection. This study analyzes the discrimination capability of the changes of the first postpacing interval (FPPI) after successive bursts of anti-tachycardia pacing (ATP) trains in implantable cardioverter-defibrillator (ICD)-recorded tachycardias. We included 50 ICD patients in this prospective study. We hypothesized that the FPPI variability (FPPIV) when comparing bursts with different numbers of beats would be shorter in ventricular tachycardias (VTs) compared with supraventricular tachycardias (SVTs). The ATP (5-10 pulses, 91% of tachycardia cycle length) was programmed for tachycardias >240 ms. Anti-tachycardia pacing was delivered during 37 sinus tachycardias (STs) in an exercise test, 96 induced VTs in an electrophysiological study, and 198 spontaneous episodes (144 VTs and 54 SVTs). The FPPI remained stable after all ATP bursts in VT but changed continuously in SVT; when comparing bursts of 5 and 10 pulses, the FPPIV was shorter in VT (34 +/- 65 vs.138 +/- 69, P<.0001, in all T and 12 +/- 20 vs. 138 +/- 69, P<.0001, in T>or=320 ms) than in SVT. In T>or=320 ms an FPPIV

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.

Perceptions of an implantable cardioverter-defibrillator: A qualitative study of families with a history of sudden life-threatening cardiac events and recommendations to improve care

PubMed Central

Linder, Jarrett; Hidayatallah, Nadia; Stolerman, Marina; McDonald, Thomas V.; Marion, Robert; Walsh, Christine; Dolan, Siobhan

2014-01-01

Objective To identify major concerns associated with implantable cardioverter-defibrillators (ICDs) and to provide recommendations to adult and pediatric physicians involved in the care of patients with ICDs. Background Cardiac ion channelopathies are a well-recognized cause of sudden cardiac death in infants, children, adolescents, and young adults. ICDs are effective in preventing sudden death from fatal arrhythmias in patients with known cardiac channelopathies. There is a paucity of research on the effect of ICDs on quality of life in patients with cardiac channelopathy diagnoses, especially young patients. Methods A qualitative study interviewing patients and families affected by inherited arrhythmias was conducted. Fifty participants with personal or family histories of cardiac events or sudden death were interviewed individually or in focus groups by clinical psychologists. All interviews were transcribed verbatim and then analyzed and coded based on current qualitative research theory to identify themes related to the research question. Twenty-four participants discussed ICDs in their interviews. Results Participants reported concerns about ICDs, and these concerns were categorized into six themes: (1) comprehension and physician-patient communication; (2) anxiety; (3) restrictions and fallacies; (4) complications; (5) utility; and (6) alternative therapy. Participants noted communication breakdowns between providers and their colleagues, and between providers and their patients. Participants and their families experienced many different forms of anxiety, including worry about the aesthetics of the ICDs and fears of being shocked. Multiple restrictions, fallacies, and complications were also cited. Conclusion Interview themes were used to formulate recommendations for counseling and educating patients with ICDs. PMID:25383067

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.

Ventricular antitachycardia pacing therapy in patients with heart failure implanted with a cardiac resynchronization therapy defibrillator device: Efficacy, safety, and impact on mortality.

PubMed

Landolina, Maurizio; Lunati, Maurizio; Boriani, Giuseppe; Pietro Ricci, Renato; Proclemer, Alessandro; Facchin, Domenico; Rordorf, Roberto; Morani, Giovanni; Maines, Massimiliano; Gasparini, Gianni; Molon, Giulio; Turrini, Pietro; Gasparini, Maurizio

2016-02-01

Cardiac resynchronization therapy defibrillator can terminate ventricular tachycardia (VT) and fast VT (FVT) via antitachycardia pacing (ATP). We evaluated efficacy and safety of ATP, whether ATP induces ventricular arrhythmias after inappropriate ATP or atrial fibrillation (AF) after appropriate ATP, and whether ATP is associated with mortality. A total of 1404 patients with a cardiac resynchronization therapy defibrillator were followed in a prospective multicenter observational research. All-cause mortality rates were estimated in patient subgroups in order to uncouple the trigger (VT/FVT or other rhythms causing inappropriate detections) from ATP therapy. Over a median follow-up of 31 months, 2938 VT/FVT episodes were treated with ATP in 360 patients. The adjusted ATP success rate was 63% (95% confidence interval [CI] 57%-69%) on FVTs and 68% (95% CI 62%-74%) on VTs. Acceleration occurred in 55 (1.87%) and syncope in 4 (0.14%) of all ATP-treated episodes. In 14 true VT/FVT episodes in 5 patients, AF followed ATP therapy. In 4 episodes in 2 patients, VT followed ATP inappropriately applied during AF. Death rate per 100 patient-years was 5.6 (95% CI 4.3-7.5) in patients with appropriate ATP and 1.5 (95% CI 0.4-6.1) in patients with inappropriate ATP (P = .045). ATP was effective in terminating VT/FVT episodes and displayed a good safety profile. ATP therapies by themselves did not increase death risk; prognosis was indeed better in patients without arrhythmic episodes, even if they received inappropriate ATP, than in patients with ATP on VT/FVT episodes. Adverse outcomes observed in patients receiving implantable cardioverter-defibrillator therapies are probably related to the arrhythmia itself, a marker of disease progression, rather than to adverse effects of ATP. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Riata silicone defibrillation lead with normal electrical measures at routine ambulatory check: The role of high-voltage shock testing

PubMed Central

De Maria, Elia; Borghi, Ambra; Bonetti, Lorenzo; Fontana, Pier Luigi; Cappelli, Stefano

2016-01-01

AIM To describe our experience with shock testing for the evaluation of patients with Riata™ leads. METHODS Among 51 patients with normal baseline electrical parameters, 20 died during follow-up. Of the remaining 31 patients, 15 underwent the test: In 10 cases a defibrillation testing with ventricular fibrillation (VF) induction and in 5 cases a R-wave-synchronized shock (> 20 J, without inducing VF). The test was performed under sedation with Midazolam. RESULTS Twelve patients (80%) had a normal behavior during shock testing: In 8 cases induced VF was correctly detected and treated; in 4 cases of R-wave-synchronized shock electrical parameters remained stable and normal. Three patients (20%) failed the test. One patient with externalized conductors showed a sudden drop of high-voltage impedance (< 10 Ohm) after a 25 J R-wave-synchronized shock. Two other patients with externalized conductors, undergoing defibrillation testing, showed a short-circuit during shock delivery and the implantable cardioverter defibrillator was unable to interrupt VF. CONCLUSION In Riata™ leads the delivery of a low current during routine measurement of high-voltage impedance may not reveal a small short circuit, that can only be evident by attempting to deliver a true shock, either for spontaneous arrhythmias or in the context of a shock testing. PMID:27957252

Effect of defibrillation threshold testing on effectiveness of the subcutaneous implantable cardioverter defibrillator.

PubMed

Peddareddy, Lakshmi; Merchant, Faisal M; Leon, Angel R; Smith, Paige; Patel, Akshar; El-Chami, Mikhael F

2018-06-12

Defibrillation threshold (DFT) testing is recommended with the subcutaneous ICD (SICD). To describe first shock efficacy for appropriate SICD therapies stratified by the presence of implant DFT testing. We reviewed all patients receiving SICDs at our institution and stratified them based on whether implant DFT testing was performed. Appropriate shocks were reviewed to see if ventricular tachycardia/ventricular fibrillation (VT/VF) terminated with a single shock. First shock efficacy was stratified by implant DFT status. 178 patients implanted with SICDs and followed in our center were included in this study. Of these, 135 (76 %) underwent DFT testing (DFT (+) group). In the DFT (+) 80 appropriate shocks were needed to treat 69 episodes of VT/VF. The first shock was effective in 61 out of 69 episodes (88.4 %), whereas multiple shocks were required to terminate VT/VF in the remaining 8 episodes. Among 43 patients without implant DFT testing (DFT (-) group), 20 appropriate shocks to treat 17 episodes of VT/VF occurred in 7 patients. VT/VF was successfully terminated with the first shock in 16 out of 17 episodes (first shock efficacy 94.1 %). There was no significant difference in first shock effectiveness between those with and without implant DFT testing (p = 0.97). A strategy that omits DFT testing at implant did not appear to compromise the effictiveness of the SICD. These data suggest that routine DFT testing at SICD implant might not be necessary. Randomized trials are needed to confirm this finding. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

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.

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

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.

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.

Longevity of implantable cardioverter-defibrillators for cardiac resynchronization therapy in current clinical practice: an analysis according to influencing factors, device generation, and manufacturer.

PubMed

Landolina, Maurizio; Curnis, Antonio; Morani, Giovanni; Vado, Antonello; Ammendola, Ernesto; D'onofrio, Antonio; Stabile, Giuseppe; Crosato, Martino; Petracci, Barbara; Ceriotti, Carlo; Bontempi, Luca; Morosato, Martina; Ballari, Gian Paolo; Gasparini, Maurizio

2015-08-01

Device replacement at the time of battery depletion of implantable cardioverter-defibrillators (ICDs) may carry a considerable risk of complications and engenders costs for healthcare systems. Therefore, ICD device longevity is extremely important both from a clinical and economic standpoint. Cardiac resynchronization therapy defibrillators (CRT-D) battery longevity is shorter than ICDs. We determined the rate of replacements for battery depletion and we identified possible determinants of early depletion in a series of patients who had undergone implantation of CRT-D devices. We retrieved data on 1726 consecutive CRT-D systems implanted from January 2008 to March 2010 in nine centres. Five years after a successful CRT-D implantation procedure, 46% of devices were replaced due to battery depletion. The time to device replacement for battery depletion differed considerably among currently available CRT-D systems from different manufacturers, with rates of batteries still in service at 5 years ranging from 52 to 88% (log-rank test, P < 0.001). Left ventricular lead output and unipolar pacing configuration were independent determinants of early depletion [hazard ratio (HR): 1.96; 95% 95% confidence interval (CI): 1.57-2.46; P < 0.001 and HR: 1.58, 95% CI: 1.25-2.01; P < 0.001, respectively]. The implantation of a recent-generation device (HR: 0.57; 95% CI: 0.45-0.72; P < 0.001), the battery chemistry and the CRT-D manufacturer (HR: 0.64; 95% CI: 0.47-0.89; P = 0.008) were additional factors associated with replacement for battery depletion. The device longevity at 5 years was 54%. High left ventricular lead output and unipolar pacing configuration were associated with early battery depletion, while recent-generation CRT-Ds displayed better longevity. Significant differences emerged among currently available CRT-D systems from different manufacturers. © The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.

Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators.

PubMed

Bates, Jonathan; Parzynski, Craig S; Dhruva, Sanket S; Coppi, Andreas; Kuntz, Richard; Li, Shu-Xia; Marinac-Dabic, Danica; Masoudi, Frederick A; Shaw, Richard E; Warner, Frederick; Krumholz, Harlan M; Ross, Joseph S

2018-06-12

To estimate medical device utilization needed to detect safety differences among implantable cardioverter defibrillators (ICDs) generator models and compare these estimates to utilization in practice. We conducted repeated sample size estimates to calculate the medical device utilization needed, systematically varying device-specific safety event rate ratios and significance levels while maintaining 80% power, testing 3 average adverse event rates (3.9, 6.1, and 12.6 events per 100 person-years) estimated from the American College of Cardiology's 2006 to 2010 National Cardiovascular Data Registry of ICDs. We then compared with actual medical device utilization. At significance level 0.05 and 80% power, 34% or fewer ICD models accrued sufficient utilization in practice to detect safety differences for rate ratios <1.15 and an average event rate of 12.6 events per 100 person-years. For average event rates of 3.9 and 12.6 events per 100 person-years, 30% and 50% of ICD models, respectively, accrued sufficient utilization for a rate ratio of 1.25, whereas 52% and 67% for a rate ratio of 1.50. Because actual ICD utilization was not uniformly distributed across ICD models, the proportion of individuals receiving any ICD that accrued sufficient utilization in practice was 0% to 21%, 32% to 70%, and 67% to 84% for rate ratios of 1.05, 1.15, and 1.25, respectively, for the range of 3 average adverse event rates. Small safety differences among ICD generator models are unlikely to be detected through routine surveillance given current ICD utilization in practice, but large safety differences can be detected for most patients at anticipated average adverse event rates. Copyright © 2018 John Wiley & Sons, Ltd.

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

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.

Electrical storm in patients with an implanted defibrillator: a matter of definition.

PubMed

Israel, Carsten W; Barold, S Serge

2007-10-01

The term "electrical storm" (ES) indicates a state of cardiac electrical instability manifested by several episodes of ventricular tachyarrhythmias (VTs) within a short time. In patients with an implantable cardioverter defibrillator (ICD), ES is best defined as 3 appropriate VT detections in 24 h, treated by antitachycardia pacing, shock or eventually untreated but sustained in a VT monitoring zone. The number of shocks and inappropriate detections are irrelevant for the definition. ES occurs in approximately 25% of ICD patients within 3 years, with typically 5-55 individual VTs within one storm. Potential triggers can be found in approximately 66% of patients and include new/worsened heart failure, changes in antiarrhythmic medication, context with other illness, psychological stress, diarrhea, and hypokalemia. In most patients, ES consists of monomorphic VT indicating the presence of reentry while ventricular fibrillation indicating acute ischemia is rare. ES seems to have a low immediate mortality (1%) but frequently (50-80%) leads to hospitalization. Long-term prognostic implications of ES are unclear. The key intervention in ES is reduction of the elevated sympathetic tone by beta blockers and frequently benzodiazepines. Amiodarone i.v. has also been successful and azimilide seems promising while class I antiarrhythmic drugs are usually unsuccessful. Substrate mapping and VT ablation may be useful in treatment and prevention of ES. Prevention of ES requires ICD programming systematically avoiding unnecessary shocks (long VT detection, antitachycardia pacing where ever possible) which otherwise can fuel the sympathetic tone and prolong ES.

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.

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.

Pacing and Defibrillators in Complex Congenital Heart Disease

PubMed Central

Chubb, Henry; O’Neill, Mark; Rosenthal, Eric

2016-01-01

Device therapy in the complex congenital heart disease (CHD) population is a challenging field. There is a myriad of devices available, but none designed specifically for the CHD patient group, and a scarcity of prospective studies to guide best practice. Baseline cardiac anatomy, prior surgical and interventional procedures, existing tachyarrhythmias and the requirement for future intervention all play a substantial role in decision making. For both pacing systems and implantable cardioverter defibrillators, numerous factors impact on the merits of system location (endovascular versus non-endovascular), lead positioning, device selection and device programming. For those with Fontan circulation and following the atrial switch procedure there are also very specific considerations regarding access and potential complications. This review discusses the published guidelines, device indications and the best available evidence for guidance of device implantation in the complex CHD population. PMID:27403295

The Selective Late Sodium Current Inhibitor Eleclazine, Unlike Amiodarone, Does Not Alter Defibrillation Threshold or Dominant Frequency of Ventricular Fibrillation.

PubMed

Silva, Ana F G; Bonatti, Rodolfo; Batatinha, Julio A P; Nearing, Bruce D; Zeng, Dewan; Belardinelli, Luiz; Verrier, Richard L

2017-03-01

We examined the effects of the selective late INa inhibitor eleclazine on the 50% probability of successful defibrillation (DFT50) before and after administration of amiodarone to determine its suitability for use in patients with implantable cardioverter defibrillators (ICDs). In 20 anesthetized pigs, transvenous active-fixation cardiac defibrillation leads were fluoroscopically positioned into right ventricular apex through jugular vein. ICDs were implanted subcutaneously. Dominant frequency of ventricular fibrillation was analyzed by fast Fourier transform. The measurements were made before drug administration (control), and at 40 minutes after vehicle, eleclazine (2 mg/kg, i.v., bolus over 15 minutes), or subsequent/single amiodarone administration (10 mg/kg, i.v., bolus over 10 minutes). Eleclazine did not alter DFT50, dominant frequency, heart rate, or mean arterial pressure (MAP). Subsequent amiodarone increased DFT50 (P = 0.006), decreased dominant frequency (P = 0.022), and reduced heart rate (P = 0.031) with no change in MAP. Amiodarone alone increased DFT50 (P = 0.005; NS compared to following eleclazine) and decreased dominant frequency (P = 0.003; NS compared to following eleclazine). Selective late INa inhibition with eleclazine does not alter DFT50 or dominant frequency of ventricular fibrillation when administered alone or in combination with amiodarone. Accordingly, eleclazine would not be anticipated to affect the margin of defibrillation safety in patients with ICDs.

Case report: use caution when applying magnets to pacemakers or defibrillators for surgery.

PubMed

Schulman, Peter M; Rozner, Marc A

2013-08-01

The application of a magnet to a pacemaker (intended to cause asynchronous pacing) or implanted cardioverter defibrillator (intended to prevent shocks) during surgery without a clear understanding of actual magnet function(s) or precautions can have unexpected, untoward, or harmful consequences. In this report, we present 3 cases in which inadequate assessment of cardiac implanted electronic device (CIED) function, coupled with magnet application, contributed to or resulted in inappropriate antitachycardia pacing or shocks, CIED damage, or patient injury. Although these cases might be rare, they reinforce the need for a timely, detailed preoperative review of CIED function and programming as recommended by the American Society of Anesthesiologists and the Heart Rhythm Society.

Defibrillator synchronization tester.

PubMed

Demirbilek, Fatma N; Krajnak, Mike; Stolarczyk, George

2009-01-01

A defibrillator sync output signal connector provides an ECG synchronization signal that can be used by some defibrillators for the purpose of performing synchronized cardioversion [1]. This process is used to stop an abnormally fast heart rate or cardiac arrhythmia by the delivery of a therapeutic dose of electric current to the heart during the R-wave of the cardiac cycle. Timing the shock to the R-wave prevents the delivery of the shock during the vulnerable period of the cardiac cycle, which could induce ventricular fibrillation [2]. GE patient monitors include a selectable analog output feature, which provides an analog ECG or arterial blood pressure signal. The blood pressure signal can be used to synchronize balloon pumps to provide cardiac assist to post-MI patients with poor injection fraction. Proper operation requires the defibrillator sync and analog output function to be checked. Checkouts are typically done during planned maintenance and after major part replacements such as patient monitor's main CPU board. Checking out defibrillator sync signals could be done using a GE defibrillator sync tester. The defibrillator sync tester provides a loop back path for the defibrillator sync signals to be displayed on the patient monitor screen and eliminates the need for an external oscilloscope.

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).

Emergency catheter ablation in critical patients

PubMed Central

Tebbenjohanns, Jürgen; Rühmkorf, Klaus

2010-01-01

Emergency catheter ablation is justified in critical patients with drug-refractory life-threatening arrhythmias. The procedure can be used for ablation of an accessory pathway in preexcitation syndrome with high risk of ventricular fibrillation and in patients with shock due to ischemic cardiomyopathy and incessant ventricular tachycardia. Emergency catheter ablation can also be justified in patients with an electrical storm of the implanted cardioverter-defibrillator or in patients with idiopathic ventricular fibrillation. PMID:20606793

Living with life insurance: a qualitative analysis of the experience of male implantable defibrillator recipients in Spain.

PubMed

Palacios-Ceña, Domingo; Losa Iglesias, Marta E; Losa, Marta E; Fernández-de-Las-Peñas, César; Salvadores-Fuentes, Paloma

2011-07-01

The implantation of defibrillators should not be studied simply on the basis of clinical improvement or quality of life: it is also important to understand the significance, which the recipients attach to the defibrillator and their experiences with it. The aim of this work was, therefore, to determine the experience of Spanish implantable defibrillator recipients. A qualitative phenomenological study. Purposeful sampling of male implantable defibrillator recipients older than 18 years of age attended at the defibrillator consultancy at the Hospital Fuenlabrada or belonging to the Heart Patients' Association (Asociación de Pacientes Coronarios, APACOR). A secondary, theoretical sampling was also carried out to gain a more in-depth understanding of certain aspects identified in the first sampling, such as living with the discharges and difficulties during sexual activity. Data were collected using unstructured and semi-structured questionnaires and applying a question guide, field notes and the recipients' personal diaries/letters. Data collection was terminated once theoretical saturation was reached. Data were analysed using the Giorgi method. Finally, the seven themes, which showed what it means to be an implantable cardioverter-defibrillator recipient, were described. The defibrillator is perceived positively and is considered to be a form of life insurance, whereas the discharges are a limiting factor. The recipient's outlook on life changes. Acceptance of the changes resulting from the implant leads to the development of strategies to facilitate everyday life. An understanding of the significance attached by recipients to their disease, diagnosis and treatment allows their behaviour and expectations to be understood. Provide the basis for nursing assessment after discharge, understand the effects of the device in the recipient and track the process of adapting the recipient to daily life. © 2011 Blackwell Publishing Ltd.

The impact of technology dependency on device acceptance and quality of life in persons with implantable cardioverter defibrillators.

PubMed

Udlis, Kimberly A

2013-01-01

The impact of implantable cardioverter defibrillator (ICD) technology on the quality of life (QOL) experienced by recipients has been a major focus of recent research. Numerous studies have found psychological distress to be important in determining QOL in persons receiving ICDs, yet the source of psychological distress is not well understood. The aim of this study was to determine the impact of technology dependency on psychological outcomes in ICD recipients. With the use of a cross-sectional design, 161 ICD recipients from 1 device clinic were mailed self-administered questionnaires, including the Dependency on Technology Scale, Brief Illness Perception Questionnaire, Florida Shock Anxiety Scale, Florida Patient Acceptance Survey, and Short Form-12 (SF-12). Hierarchical multiple regressions and analyses of variance were performed. The final sample size was 101 participants. Mean (SD) age was 68 (13) years; 72% of the participants were men, 99% were white, and 30% reported receiving a shock(s). A total of 80% reported positive attitudes toward technology dependency; 14%, neutral; and 6%, negative (Dependency on Technology Scale). Illness perceptions were positive (Brief Illness Perception Questionnaire; mean[SD], 34.5 [12.6]), shock anxiety was elevated (Florida Shock Anxiety Scale; mean [SD], 16.5 [6.7]), and device acceptance was good (Florida Patient Acceptance Survey; mean [SD], 74.9 [17.0]). Physical health QOL was low (SF-12; mean [SD], 38.6 [11.3]) and mental health QOL was moderate (SF-12; mean [SD], 50.6 [10.0]). Attitudes toward technology dependency significantly accounted for the variance seen in device acceptance and mental health QOL beyond age, gender, number of shocks, illness perceptions, and shock anxiety by 5.7% (P = .001) and 3.3% (P = .04), respectively. Significant differences were seen in device acceptance between those with negative and neutral attitudes (P = .001) and those with negative and positive attitudes (P < .001) and in shock

Implantable Cardioverter Defibrillator

MedlinePlus

... patients will benefit from an ICD. Improving ICD design. Although high-energy shocks are effective therapy for ... patients with many stressful decisions, and this study tests the effectiveness of educational videos and handouts to ...

Should an implanted defibrillator be considered in patients with vasospastic angina?

PubMed

Eschalier, Romain; Souteyrand, Géraud; Jean, Frédéric; Roux, Antoine; Combaret, Nicolas; Saludas, Yannick; Clerfond, Guillaume; Barber-Chamoux, Nicolas; Citron, Bernard; Lusson, Jean-René; Brugada, Pedro; Motreff, Pascal

2014-01-01

Vasospastic angina is a frequent and well-recognized pathology with a high risk of life-threatening ventricular arrhythmias and sudden cardiac death. The diagnosis of vasospastic angina requires the combination of clinical and electrocardiographic variables and the results of provocation tests, such as ergonovine administration. Smoking cessation is the first step in the management of vasospastic angina. Optimal medical treatment using calcium-channel blockers and/or nitrate derivatives can provide protection, but life-threatening ventricular arrhythmias may occur despite optimal medical treatment and several years after the start of treatment. In this review, we evaluate the role of implantable defibrillators as a complement to optimal medical management in patients with life-threatening ventricular arrhythmias due to vasospastic angina; this role is not well characterized in the literature or guidelines. We discuss the role of implantable defibrillators in secondary prevention in light of three recent cases managed in our departments and a review of the literature. An implantable defibrillator was implanted in two of the three cases of vasospastic angina with ventricular arrhythmias that we managed. We considered secondary prevention by implantable defibrillator to be justified even in the absence of any obvious risk factor. Ventricular arrhythmias recurred during implantable defibrillator follow-up in the two patients implanted. In patients with life-threatening ventricular arrhythmias due to vasospastic angina, an implantable defibrillator should be considered because of the risk of recurrence despite optimal medical management. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

Inadvertent transarterial insertion of atrial and ventricular defibrillator leads.

PubMed

Issa, Ziad F; Rumman, Syeda S; Mullin, James C

2009-01-01

Inadvertent placement of pacemaker and implantable cardioverter-defibrillator (ICD) leads in the left ventricle (LV) is a rare but well-recognized complication of device implantation [1]. We report a case of inadvertent transarterial implantation of dual-chamber ICD leads; the ventricular lead positioned in the LV and the atrial lead positioned in the aortic root. The tip of the atrial lead migrated across the aortic wall and captured the epicardial surface of the left atrium. The diagnosis was made 5 years after the implantation procedure with no apparent adverse events directly related to left heart lead placement.

Impact of pacing and high-pass filter settings on ventricular bipolar electrograms in implantable cardioverter defibrillator systems. - Implication of predictors for inappropriate therapy caused by oversensing of repolarization electrograms-.

PubMed

Maesato, Akira; Higa, Satoshi; Lin, Yenn-Jiang; Chinen, Ichiro; Ishigaki, Sugako; Yajima, Machiko; Masuzaki, Hiroaki; Chen, Shih-Ann

2011-01-01

Predictors of T wave oversensing with implantable cardioverter-defibrillator (ICD) systems remains to be clarified. Thirteen consecutive patients who underwent ICD implantations were included. The depolarization (R) and repolarization (T) of bipolar electrograms during baseline, AAI and DDD modes, and an isoproterenol (ISO) infusion were evaluated. The R wave amplitude during DDD was significantly lower as compared to that during the other conditions in all high-pass filter settings. In contrast, there was no significant difference in the T wave amplitude during the DDD as compared to the other conditions. With the DDD, there was a significantly higher incidence of a T/R ratio of greater than 0.25 as compared to that with the other conditions. T wave amplitude in Brugada syndrome was significantly higher than that in non-Brugada syndrome. The existence of Brugada syndrome and T/R ratio during the AAI with a high-pass filter setting of 10/20 Hz was an excellent predictor of T wave oversensing in the follow-up period. DDD had a significant impact on the R wave amplitude reduction and the T/R ratio during AAI can be predictors of T wave oversensing. These findings have important implications for inappropriate shocks due to T wave oversensing.

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.

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.

Tricuspid Valve Dysfunction Following Pacemaker or Cardioverter-Defibrillator Implantation.

PubMed

Chang, James D; Manning, Warren J; Ebrille, Elisa; Zimetbaum, Peter J

2017-05-09

The potential for cardiac implantable electronic device leads to interfere with tricuspid valve (TV) function has gained increasing recognition as having hemodynamic and clinical consequences associated with incremental morbidity and death. The diagnosis and treatment of lead-related (as distinct from functional) tricuspid regurgitation pose unique challenges. Because of pitfalls in routine diagnostic imaging, a high level of clinical suspicion must be maintained to avoid overlooking the possibility that worsening heart failure is a consequence of mechanical interference with TV leaflet mobility or coaptation and is amenable to lead extraction or valve repair or replacement. The future of cardiac implantable electronic devices includes pacing and perhaps defibrillation without a lead traversing the TV. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

[Subcutaneous implantable cardioverter-defibrillator in prevention of sudden cardiac death in Poland - opinion paper endorsed by the Polish Cardiac Society Working Group on Heart Rhythm].

PubMed

Ptaszyński, Paweł; Grabowski, Marcin; Kowalski, Oskar; Kempa, Maciej; Mitkowski, Przemysław; Przybylski, Andrzej; Sterliński, Maciej

2017-01-01

In the past years, cardiovascular mortality has decreased but despite these cardiovascular diseases are responsible for millions of deaths every year in the world and approximately 25% of which are sudden cardiac death (SCD). Implantable defibrillators (ICD) is proven therapy used in primary and secondary SCD prevention. Currently majority of devices use transvenous leads inserted predominantly into the right heart for both pacing and defibrillation. On the other hand, ICD may cause complica-tions, including inappropriate shocks, device-related infection and lead failure. Problems with transvenous leads prompted the development of a subcutaneous defibrillator (S-ICD) with an electrode system that is placed entirely subcutaneously, outside the thoracic cavity. The device may be useful when venous access is difficult, in young patients and in patients at particular risk of infection. S-ICD is not suitable for patients with indications for bradycardia pacing, cardiac resynchronisation therapy and in cases with tachyarrhythmia easily terminated by antitachycardia pacing.

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.

Preliminary Development of an Informational Media Use Measure for Patients with Implanted Defibrillators: Toward a Model of Social-Ecological Assessment of Patient Education and Support.

PubMed

Knoepke, Christopher E; Matlock, Daniel D

2017-11-01

Social work interventions in health care, particularly those that involve working with people being treated for chronic and life-threatening conditions, frequently involve efforts to educate patients about their disease, treatment options, safety planning, medical adherence, and other associated issues. Despite an intuitive notion that patients access information about all of these issues through a variety of media-both inside and outside the clinical encounter, created by professionals and by others-there currently exists no validated means of assessing patients' use of these forms of information. To address this gap, authors first created candidate item measures with input from both physicians and a small group of diverse patients who currently have an implantable cardioverter defibrillator (ICD), a sophisticated cardiac device for which a trajectory model of social work intervention was recently outlined. Authors then surveyed a group of 205 individuals who have these devices, assessing their use of various media to learn about ICDs. They then conducted factor and item analysis to refine and remove poorly performing items while delineating forms of media use by type. The resultant preliminary measure of informational media use can be further refined and adapted for use with any clinical population. © 2017 National Association of Social Workers.

Safety of implantable pacemakers and cardioverter defibrillators in the magnetic field of a novel remote magnetic navigation system.

PubMed

Jilek, Clemens; Tzeis, Stylianos; Reents, Tilko; Estner, Heidi-Luise; Fichtner, Stephanie; Ammar, Sonia; Wu, Jinjin; Hessling, Gabriele; Deisenhofer, Isabel; Kolb, Christof

2010-10-01

Electromagnetic interference with pacemaker and implantable cardioverter defibrillator (ICD) systems may cause temporary or permanent system malfunction of implanted devices. The aim of this study was to evaluate potential interference of a novel magnetic navigation system with implantable rhythm devices. A total of 121 devices (77 pacemakers, 44 ICDs) were exposed to an activated NIOBE II® Magnetic Navigation System (Stereotaxis, St. Louis, MO, USA) at the maximal magnetic field strength of 0.1 Tesla and evaluated in vitro with respect to changes in parameter settings of the device, changes of the battery status/detection of elective replacement indication, or alterations of data stored in the device. A total of 115 out of 121 (95%) devices were free of changes in parameter settings, battery status, and internally stored data after repeated exposition to the electromagnetic field of the remote magnetic navigation system. Interference with the magnetic navigation field was observed in 6 pacemakers, resulting in reprogramming to a power-on-reset mode with or without detection of the elective replacement indication in 5 devices and abnormal variance of battery status in one device. All pacemakers could be reprogrammed to the initial modes and the battery status proved to be normal some minutes after the pacemakers had been removed from the magnetic field. Interference of a remote magnetic navigation system (at maximal field strength) with pacemakers and ICDs not connected to leads with antitachycardic detection and therapies turned off is rare. Occurring functional abnormalities could be reprogrammed in our sample. An in vitro study will give information about interference of devices connected to leads. © 2010 Wiley Periodicals, Inc.

Magnetic Resonance Imaging in Nondependent Pacemaker Patients with Pacemakers and Defibrillators with a Nearly Depleted Battery.

PubMed

Okamura, Hideo; Padmanabhan, Deepak; Watson, Robert E; Dalzell, Connie; Acker, Nancy; Jondal, Mary; Romme, Abby L; Cha, Yong-Mei; Asirvatham, Samuel J; Felmlee, Joel P; Friedman, Paul A

2017-05-01

Magnetic resonance imaging (MRI) in patients with non-MRI-conditional cardiac implantable electronic devices (CIEDs) has been shown to be safe when performed under closely monitored protocols. However, the safety of MRI in patients with devices with a nearly depleted battery has not been reported. Prospective data were collected between January 2008 and May 2015 in patients with non-MRI-conditional CIEDs undergoing clinically indicated MRI under institutional protocol. Patients who were pacemaker dependent were excluded. Patients whose devices were at elective replacement indicator (ERI) at the time of MRI or close to ERI (ERI or replacement for battery depletion within 3 months of scan) were identified through database review and analyzed for clinical events. MRI scans (n = 569) were performed in 442 patients. Of these, we identified 13 scans performed with a nearly depleted battery in nine patients. All scans with implantable cardioverter defibrillators (ICDs, n = 9) were uneventful. However, two scans with pacemakers close to ERI resulted in a power-on-reset (PoR) event. One scan with a pacemaker close to ERI that was programmed to DOO mode reached ERI during MRI and automatically changed to VVI mode. Additionally, one scan with a pacemaker at ERI did not allow programming. All pacemakers with events were implanted before 2005. Patients with pacemakers and ICDs with a nearly depleted battery can safely undergo MRI when patients are not pacemaker dependent. Attention should be paid because old devices can result in PoR or ERI during MRI, which may lead to oversensing and inhibition of pacing. © 2017 Wiley Periodicals, Inc.

78 FR 23768 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-22

... Beneficiaries Receiving Implantable Cardioverter- Defibrillators for Primary Prevention of Sudden Cardiac Death; Use: CMS provides coverage for implantable cardioverter-defibrillators (ICDs) for secondary prevention... Defibrillators'' on January 27, 2005, indicating that ICDs will be covered for primary prevention of sudden...

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.

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

PubMed

Abraham, William T

2013-06-01

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

Right Ventricular Ejection Fraction Is Incremental to Left Ventricular Ejection Fraction for the Prediction of Future Arrhythmic Events in Patients With Systolic Dysfunction.

PubMed

Mikami, Yoko; Jolly, Umjeet; Heydari, Bobak; Peng, Mingkai; Almehmadi, Fahad; Zahrani, Mohammed; Bokhari, Mahmoud; Stirrat, John; Lydell, Carmen P; Howarth, Andrew G; Yee, Raymond; White, James A

2017-01-01

Left ventricular ejection fraction remains the primary risk stratification tool used in the selection of patients for implantable cardioverter defibrillator therapy. However, this solitary marker fails to identify a substantial portion of patients experiencing sudden cardiac arrest. In this study, we examined the incremental value of considering right ventricular ejection fraction for the prediction of future arrhythmic events in patients with systolic dysfunction using the gold standard of cardiovascular magnetic resonance. Three hundred fourteen consecutive patients with ischemic cardiomyopathy or nonischemic dilated cardiomyopathy undergoing cardiovascular magnetic resonance were followed for the primary outcome of sudden cardiac arrest or appropriate implantable cardioverter defibrillator therapy. Blinded quantification of left ventricular and right ventricular (RV) volumes was performed from standard cine imaging. Quantification of fibrosis from late gadolinium enhancement imaging was incrementally performed. RV dysfunction was defined as right ventricular ejection fraction ≤45%. Among all patients (164 ischemic cardiomyopathy, 150 nonischemic dilated cardiomyopathy), the mean left ventricular ejection fraction was 32±12% (range, 6-54%) with mean right ventricular ejection fraction of 48±15% (range, 7-78%). At a median of 773 days, 49 patients (15.6%) experienced the primary outcome (9 sudden cardiac arrest, 40 appropriate implantable cardioverter defibrillator therapies). RV dysfunction was independently predictive of the primary outcome (hazard ratio=2.98; P=0.002). Among those with a left ventricular ejection fraction >35% (N=121; mean left ventricular ejection fraction, 45±6%), RV dysfunction provided an adjusted hazard ratio of 4.2 (P=0.02). RV dysfunction is a strong, independent predictor of arrhythmic events. Among patients with mild to moderate LV dysfunction, a cohort greatly contributing to global sudden cardiac arrest burden, this marker

The Relationship Between Level of Adherence to Automatic Wireless Remote Monitoring and Survival in Pacemaker and Defibrillator Patients.

PubMed

Varma, Niraj; Piccini, Jonathan P; Snell, Jeffery; Fischer, Avi; Dalal, Nirav; Mittal, Suneet

2015-06-23

Remote monitoring (RM) technology embedded within cardiac rhythm devices permits continuous monitoring, which may result in improved patient outcomes. This study used "big data" to assess whether RM is associated with improved survival and whether this is influenced by the type of cardiac device and/or its degree of use. We studied 269,471 consecutive U.S. patients implanted between 2008 and 2011 with pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), or cardiac resynchronization therapy (CRT) with pacing capability (CRT-P)/defibrillation capability (CRT-D) with wireless RM. We analyzed weekly use and all-cause survival for each device type by the percentage of time in RM (%TRM) stratified by age. Socioeconomic influences on %TRM were assessed using 8 census variables from 2012. The group had implanted PMs (n = 115,076; 43%), ICDs (n = 85,014; 32%), CRT-D (n = 61,475; 23%), and CRT-P (n = 7,906; 3%). When considered together, 127,706 patients (47%) used RM, of whom 67,920 (53%) had ≥75%TRM (high %TRM) and 59,786 (47%) <75%TRM (low %TRM); 141,765 (53%) never used RM (RM None). RM use was not affected by age or sex, but demonstrated wide geographic and socioeconomic variability. Survival was better in high %TRM versus RM None (hazard ratio [HR]: 2.10; p < 0.001), in high %TRM versus low %TRM (HR: 1.32; p < 0.001), and also in low %TRM versus RM None (HR: 1.58; p < 0.001). The same relationship was observed when assessed by individual device type. RM is associated with improved survival, irrespective of device type (including PMs), but demonstrates a graded relationship with the level of adherence. The results support the increased application of RM to improve patient outcomes. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Monophasic versus biphasic defibrillation for pediatric out-of-hospital cardiac arrest patients: a nationwide population-based study in Japan

PubMed Central

2012-01-01

Introduction Conventional monophasic defibrillators for out-of-hospital cardiac-arrest patients have been replaced with biphasic defibrillators. However, the advantage of biphasic over monophasic defibrillation for pediatric out-of-hospital cardiac-arrest patients remains unknown. This study aimed to compare the survival outcomes of pediatric out-of-hospital cardiac-arrest patients who underwent monophasic defibrillation with those who underwent biphasic defibrillation. Methods This prospective, nationwide, population-based observational study included pediatric out-of-hospital cardiac-arrest patients from January 1, 2005, to December 31, 2009. The primary outcome measure was survival at 1 month with minimal neurologic impairment. The secondary outcome measures were survival at 1 month and the return of spontaneous circulation before hospital arrival. Multivariable logistic regression analysis was performed to identify the independent association between defibrillator type (monophasic or biphasic) and outcomes. Results Among 5,628 pediatric out-of-hospital cardiac-arrest patients (1 through 17 years old), 430 who received defibrillation shock with monophasic or biphasic defibrillator were analyzed. The number of patients who received defibrillation shock with monophasic defibrillator was 127 (30%), and 303 (70%) received defibrillation shock with biphasic defibrillator. The survival rates at 1 month with minimal neurologic impairment were 17.5% and 24.4%, the survival rates at 1 month were 32.3% and 35.6%, and the rates of return of spontaneous circulation before hospital arrival were 24.4% and 27.4% in the monophasic and biphasic defibrillator groups, respectively. Hierarchic logistic regression analyses by using generalized estimation equations found no significant difference between the two groups in terms of 1-month survival with minimal neurologic impairment (odds ratio (OR), 1.57; 95% confidence interval (CI), 0.87 to 2.83; P = 0.14) and 1-month survival (OR

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.

Sexual Health for Patients with an Implantable Cardioverter Defibrillator

MedlinePlus

... patients and proposed strategies for overcoming those barriers. Communication Between Patients and Healthcare Providers Although some people ... Unfortunately, research has shown a lack of adequate communication about sex between cardiovascular patients and their healthcare ...

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