Impact Of Implantable Cardioverter-defibrillator Research Articles

Multicenter prospective observational study to clarify the current status and clinical outcome in Japanese patients who have an indication for implantable cardioverter defibrillator (ICD) or wearable cardioverter defibrillator (WCD) (TRANSITION JAPAN‐ICD/WCD study): Rationale and design of a prospective, multicenter, observational, comparative study

AbstractBackgroundDespite the positive impact of implantable cardioverter defibrillators (ICDs) and wearable cardioverter defibrillators (WCDs) on prognosis, their implantation is often withheld especially in Japanese heart failure patients with reduced left ventricular ejection fraction (HFrEF) who have not experienced ventricular tachycardia (VT) or ventricular fibrillation (VF) for uncertain reasons. Recent advancements in heart failure (HF) medications have significantly improved the prognosis for HFrEF. Given this context, a critical reassessment of the treatment and prognosis of ICDs and WCDs is essential, as it has the potential to reshape awareness and treatment strategies for these patients.MethodsWe are initiating a prospective multicenter observational study for HFrEF patients eligible for ICD in primary and secondary prevention, and WCD, regardless of device use, including all consenting patients. Study subjects are to be enrolled from 31 participant hospitals located throughout Japan from April 1, 2023, to December 31, 2024, and each will be followed up for 1 year or more. The planned sample size is 651 cases. The primary endpoint is the rate of cardiac implantable electronic device implementation. Other endpoints include the incidence of VT/VF and sudden death, all‐cause mortality, and HF hospitalization, other events. We will collect clinical background information plus each patient's symptoms, Clinical Frailty Scale score, laboratory test results, echocardiographic and electrocardiographic parameters, and serial changes will also be secondary endpoints.ResultsNot applicable.ConclusionThis study offers invaluable insights into understanding the role of ICD/WCD in Japanese HF patients in the new era of HF medication.

Prognostic impact of implantable cardioverter defibrillators and associated adverse events in patients with continuous flow left ventricular assist devices.

Implantation of implantable cardioverter defibrillators (ICD) reduces the risk of all-cause mortality in symptomatic heart failure (HF) patients with severe left ventricular (LV) dysfunction. Nevertheless, the prognostic impact of ICD therapy in continuous flow left ventricular assist device (LVAD) recipients remains controversial. 162 consecutive HF patients, who underwent LVAD implantation at our institution between 2010 and 2019, were categorized according to the presence (n = 94, ICD-group) or absence (n = 68, Control-group) of ICDs. Apart from clinical baseline and follow-up parameters, adverse events (AEs) related to ICD therapy and overall survival rates were retrospectively analyzed. Out of 162 consecutive LVAD recipients 79 patients (48.8%) were preoperatively categorized as Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile ≤2. The prevalence of severe HF symptoms and preoperative use of short-term circulatory support devices (54.4% vs. 13.8%, p < 0.001) was higher within the Control-group, although baseline severity of LV and RV dysfunction was similar. Apart from an increased prevalence of perioperative right heart failure (RHF) within the Control-group (45.6% vs. 17.0%; p < 0.001), procedural characteristics and perioperative outcome were similar. Overall-survival during a median follow-up of 14 (3.0-36.5) months was similar within both groups (p = 0.46). During the first 2 years after LVAD implantation 53 ICD-related AEs occurred within the ICD-group. Thereof, lead-dysfunction occurred in 19 patients and unplanned ICD-reintervention in 11 patients. Furthermore, in 18 patients appropriate shocks without loss of consciousness occurred, whereas inappropriate shocks occurred in 5 patients. ICD therapy in LVAD recipients was not associated with a survival benefit or reduced morbidity after LVAD implantation. Conservative ICD-programming seems to be justified to avoid ICD-related complications and "awake shocks" after LVAD implantation.

The impact of implantable cardioverter defibrillator on the prognosis of nonischemic dilated cardiomyopathy patients compared with standard medical treatments.

Patients with nonischemic dilated cardiomyopathy (DCM)are susceptible to arrhythmias and implantable cardioverter defibrillator (ICD)in addition to medical treatments may help prevent sudden cardiac death (SCD)and improve survival in this population. We aim to investigate the impact of ICD insertion on survival and prognosis of patients with nonischemic DCM. We retrospectively analyzed data from patients with nonischemic DCM treated with medical therapy with or without ICD who referred to our hospital from January 2020 to November 2021. Patients were divided based on the treatment that they had received into two equal groups. Different variables including demographic features, comorbidities, medical treatments, hospitalization rate, function class,and left ventricular ejection fractionbefore and after treatments were investigated in this study. In addition, variables in survival including overall survival (OS) andSCDwere compared between the two groups. A total of 120 patients were investigated in this study. Mean ± SDof age and follow-up time of patients were 64.0 ± 12.7 years old and 61.2 ± 15.9 months, respectively. Ten (16.7%) patients with medical therapy, and seven (11.7%) patients with ICD and medical therapy died during the follow-up period (p = 0.25).However, the two groups had a significant difference regarding SCD (11.7% vs. 1.7%, p = 0.02). In patients with nonischemic DCM who had undergone ICD insertion in addition to standard medical treatments, SCD was significantly reduced compared with patients receiving just medical treatments. OS had no significant difference between our two studied groups.

Ventricular arrhythmias following coronary artery bypass grafting for ischemic cardiomyopathy: When to insert an implanted cardioverter defibrillator?

ObjectivesThe study objectives were to determine the incidence, predictors, and clinical impact of ventricular arrhythmias after coronary artery bypass grafting and to evaluate the impact of implantable cardioverter defibrillators on the survival of patients with ventricular arrhythmias. MethodsWe enrolled 498 patients with a left ventricular ejection fraction of 40% or less who underwent coronary artery bypass grafting between 1993 and 2015. Clinical follow-up was completed in 94.0% of patients, with a median follow-up of 58.4 months. ResultsOverall, 212 patients (43%) died, mainly of heart failure (n = 54, 10.8%) or sudden cardiac death (n = 40, 8.0%). The sudden cardiac death rate was highest during the first 6 months, with a monthly rate of 0.37%. Overall, 99 patients (20%) developed postoperative ventricular arrhythmias, and implantable cardioverter defibrillator was implanted in 55 patients. Previous ventricular arrhythmias (hazard ratio, 3.22; 95% confidence interval, 1.98-5.24; P < .001), left ventricular end-systolic dimension (hazard ratio, 1.07; 95% confidence interval, 1.04-1.10; P < .001), and myocardial infarction in the left anterior descending artery territory (hazard ratio, 1.73; 95% confidence interval, 1.10-2.73; P = .02) were independent predictors of postoperative ventricular arrhythmias. Notably, the 5-year survival of patients with ventricular arrhythmias who received an implantable cardioverter defibrillator was significantly higher than that of patients with ventricular arrhythmias who did not receive it (76.1% vs 22.7%, P < .001) and was comparable to that of patients without ventricular arrhythmias (76.1% vs 73.6%, P = .98). ConclusionsSudden cardiac death affects a significant proportion of patients with ischemic cardiomyopathy undergoing coronary artery bypass grafting, most frequently within 6 months postoperatively. To prevent sudden cardiac death, earlier implantable cardioverter defibrillator implantation should be indicated for high-risk patients with scars in the left anterior descending artery territory and excessive left ventricular remodeling.

Prognostic Impact of Implantable Cardioverter Defibrillators in Patients with Continuous Flow Left Ventricular Assist Devices

Purpose Preventative implantation of implantable cardioverter defibrillators (ICD) improves survival of symptomatic heart failure (HF) patients with reduced left ventricular ejection fraction. Nevertheless, the prognostic impact of ICD therapy in continuous flow left ventricular assist device (LVAD) recipients remains controversial. Methods 162 consecutive HF patients underwent LVAD implantation at our institution between 2010 and 2019. All patients were evaluated according to the presence (n=94, ICD-group) or absence (n=68, Control-group) of ICDs prior to LVAD implantation. Apart from clinical baseline and follow-up parameters, adverse events related to ICD therapy and overall survival rates were retrospectively analyzed. Results Predominantly male patients (87.0%) with a median age of 57 (48.8-64.0) years were mainly treated with the Medtronic HVAD device (87.0%). Ischemic cardiomyopathy (60.3% vs. 38.3%, p=0.007) and severe HF symptoms (e.g., NYHA-class IV 85.5% vs. 59.6%, p=0.001) were more prevalent within the Control-group. Furthermore, the preoperative use of short-term circulatory support devices (e.g., IABP, ECMO, Impella) was higher within the Control-group (54.4% vs. 13.8%, p <0.001). Nevertheless, baseline severity of LV and RV dysfunction (LVEF 20%, TAPSE 15mm; p=0.87) was similar. Apart from an increased rate of temporary RVAD implantation within the Control-group (45.6% vs. 17.0%; p<0.001), procedural characteristics and 30-day mortality rates were comparable. Furthermore, overall-survival during a median follow-up of 14 (3.0-36.5) months was similar within both study-groups (35.1% ICD-group vs. 33.8% Control-group; p=0.46). During the first 2 years after LVAD implantation 49 ICD-related adverse events occurred within the ICD-group. Thereof, lead-dysfunction occurred in 18 patients and unplanned ICD-reintervention in 10 patients. Furthermore, in 16 patients adequate, but awake shocks occurred, whereas inadequate shocks occurred in 5 patients. Conclusion ICD therapy in LVAD recipients was not associated with a survival benefit or reduced morbidity after LVAD implantation. Furthermore, in the majority of LVAD recipients ICD-related adverse events occurred during follow-up. A randomized controlled trial is essential to elucidate the role of ICD therapy in LVAD recipients. Preventative implantation of implantable cardioverter defibrillators (ICD) improves survival of symptomatic heart failure (HF) patients with reduced left ventricular ejection fraction. Nevertheless, the prognostic impact of ICD therapy in continuous flow left ventricular assist device (LVAD) recipients remains controversial. 162 consecutive HF patients underwent LVAD implantation at our institution between 2010 and 2019. All patients were evaluated according to the presence (n=94, ICD-group) or absence (n=68, Control-group) of ICDs prior to LVAD implantation. Apart from clinical baseline and follow-up parameters, adverse events related to ICD therapy and overall survival rates were retrospectively analyzed. Predominantly male patients (87.0%) with a median age of 57 (48.8-64.0) years were mainly treated with the Medtronic HVAD device (87.0%). Ischemic cardiomyopathy (60.3% vs. 38.3%, p=0.007) and severe HF symptoms (e.g., NYHA-class IV 85.5% vs. 59.6%, p=0.001) were more prevalent within the Control-group. Furthermore, the preoperative use of short-term circulatory support devices (e.g., IABP, ECMO, Impella) was higher within the Control-group (54.4% vs. 13.8%, p <0.001). Nevertheless, baseline severity of LV and RV dysfunction (LVEF 20%, TAPSE 15mm; p=0.87) was similar. Apart from an increased rate of temporary RVAD implantation within the Control-group (45.6% vs. 17.0%; p<0.001), procedural characteristics and 30-day mortality rates were comparable. Furthermore, overall-survival during a median follow-up of 14 (3.0-36.5) months was similar within both study-groups (35.1% ICD-group vs. 33.8% Control-group; p=0.46). During the first 2 years after LVAD implantation 49 ICD-related adverse events occurred within the ICD-group. Thereof, lead-dysfunction occurred in 18 patients and unplanned ICD-reintervention in 10 patients. Furthermore, in 16 patients adequate, but awake shocks occurred, whereas inadequate shocks occurred in 5 patients. ICD therapy in LVAD recipients was not associated with a survival benefit or reduced morbidity after LVAD implantation. Furthermore, in the majority of LVAD recipients ICD-related adverse events occurred during follow-up. A randomized controlled trial is essential to elucidate the role of ICD therapy in LVAD recipients.

Grey zones in the supportive treatments of cardiac amyloidosis

Recent advances in the diagnosis and treatment of cardiac amyloidosis (CA) have translated into a longer life expectancy of patients and more challenging clinical scenarios. Compared to the past, patients with CA and heart failure (HF) currently encountered in clinical practice are a more heterogeneous population and require tailored strategies. The perception of CA as a treatable disease has opened new possibilities for the management of these patients, but many grey areas remain to be explored. The aim of this review is to provide practical suggestions for daily clinical activity in the management of challenging scenarios in CA, including the effectiveness and tolerability of evidence-based HF medication; rate vs. rhythm control in atrial fibrillation, thromboembolic risk, and anticoagulation therapies; replacement of severe aortic valve stenosis; the impact of implantable cardioverter defibrillator on survival; and the usefulness of cardiac resynchronization therapy.

Long-Term Follow-up of Standard and Small Diameter Implantable Cardioverter Leads

Background: Small-diameter implantable cardioverter-defibrillator (ICD) leads have been introduced into clinical practice to facilitate the implantation procedure. Despite their expected benefits, the reliability of these leads has proven to be questionable. The main purpose of our study is to investigate the impact of ICD lead diameter (≤8 F versus &gt;8 F) on long-term lead durability. Methods: Overall, 206 consecutive patients implanted with a right ventricular ICD lead in the Electrophysiology and Cardiac Pacing Unit of our department from January 2008 to December 2013 were included in this analysis. ICD leads were defined, according to their diameter, as small (≤8 F) and standard (&gt;8 F).The small-diameter leads (n=106) included Linox (Biotronik; n=58) and Durata (St. Jude Medical/Abbot; n=48). The standard-diameter ICD leads (n=100) consisted of Sprint Quattro (Medtronic; n=64) and Endotak (Boston Scientific; n=36). Results: After a median follow-up of 7.3 years, lead failure rate was significantly increased for small-diameter leads compared with standard-diameter leads (6.6% vs 1%; P=0.035). No difference in lead survival probability has been observed between Linox and Durata small-diameter leads (93% vs 92.7%; P=0.71). The majority of lead failures presented as noise (87.5%), without detectable abnormalities on fluoroscopic evaluation. Conclusion: Our single-centre study showed that both Linox and Durata small-diameter ICD are associated to be more susceptible to a greater risk of lead failure as compared to standard-diameter ICD leads. In this perspective, a comprehensive vigilance strategy including home monitoring is warranted for early detection of lead failure.

Survival After Implantable Cardioverter-Defibrillator Shocks

BackgroundThere are conflicting data on the impact of implantable cardioverter-defibrillator (ICD) shocks on subsequent mortality. ObjectivesThe aim of this study was to determine whether the arrhythmic substrate leading to ICD therapy or the therapy itself increases mortality. MethodsThe study cohort included 5,516 ICD recipients who were enrolled in 5 landmark ICD trials (MADIT-II, MADIT-RISK, MADIT-CRT, MADIT-RIT, RAID). The authors evaluated the association of device therapy with subsequent mortality in 4 separate time-dependent models: model I, type of ICD therapy; model II, type of arrhythmia for which ICD therapy was delivered; model III, combined assessment of all arrhythmia and therapy types during follow-up; and model IV, incremental risk associated with repeated ICD shocks. ResultsWhen analyzed by the type of ICD therapy (model I), a first appropriate ICD shock was associated with increased risk of subsequent mortality with or without concomitant occurrence of inappropriate shock during follow-up (hazard ratio [HR]: 2.78 and 2.31; p < 0.001 and p = 0.12), whereas inappropriate shock alone was not associated with mortality risk (HR: 1.23; p = 0.42). Similarly, ICD therapy for ventricular tachycardia (VT) ≥200 beats/min or ventricular fibrillation (VF) (model II) was associated with increased risk of death with or without concomitant therapy for VT <200 beats/min (HRs: 2.25 and 2.62; both p < 0.001), whereas appropriate therapy for VT <200 beats/min or inappropriate therapy (regardless of etiology) did not reach statistical significance (all p > 0.10). Combined assessment of all therapy and arrhythmia types during follow-up (model III) showed that appropriate ICD shocks for VF, shocks for fast VT (≥200 beats/min) without prior antitachycardia pacing (ATP), as well as shocks for fast VT delivered after failed ATP, were associated with the highest risk of subsequent death (HR: all >2.8; p < 0.001). Finally, 2 or more ICD appropriate shocks were not associated with incremental risk to the first appropriate ICD shock (model IV). ConclusionThe combined data from 5 landmark ICD trials suggest that the underlying arrhythmic substrate rather than the ICD therapy is the more important determinant of mortality in ICD recipients.

Sacubitril/Valsartan and Sudden Cardiac Death According to Implantable Cardioverter-Defibrillator Use and Heart Failure Cause: A PARADIGM-HF Analysis

ObjectivesThe purpose of this study was to investigate the effect of sacubitril/valsartan therapy on sudden cardiac death (SCD) according to the use of and eligibility for an implantable cardioverter-defibrillator (ICD), stratified by heart failure cause. BackgroundSCD still accounts for a significant proportion of overall mortality in heart failure with reduced ejection fraction (HFrEF). MethodsPatients enrolled in the PARADIGM-HF (Prospective Comparison of ARNI with an ACE-Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial (n = 8,399) were evaluated to assess patterns of ICD implantation and eligibility according to clinical guidelines. The impact of ICD (adjusted for propensity of ICD implantation) and sacubitril/valsartan therapy on SCD was evaluated by using cause-specific Cox models and competing risk analysis. ResultsAt baseline, of the 7,145 patients (85%) eligible for ICD implantation, only 1,243 (15%) had an ICD. Use of ICD varied by region with the highest rates in North America (56%) and lowest in Asia-Pacific (1.7%). In a propensity score-adjusted analysis, use of an ICD was associated with a 56% lower risk of SCD in ICD-eligible patients, in both patients with ischemic (p < 0.001) and nonischemic cardiomyopathy (p = 0.02). Sacubitril/valsartan reduced SCD risk in patients with an ICD (hazard ratio [HR]: 0.49; 95% confidence interval [CI]: 0.25 to 0.99) and in those who were eligible for but did not receive an ICD (HR: 0.81; 95% CI: 0.67 to 0.98). This effect was particularly evident in nonischemic cardiomyopathy (p < 0.05), although interaction with the cause of HF was not significant (p = 0.11 in subjects using an ICD and p = 0.25 in eligible nonusers). ConclusionsUse of an ICD was associated with lower rates of SCD, regardless of HF cause but was underused in most regions of the world in the PARADIGM-HF study. Sacubitril/valsartan reduced SCD risk regardless of use of an ICD or eligibility, particularly in ICD users and nonischemic cardiomyopathy.

Disparity Between Indications for and Utilization of Implantable Cardioverter Defibrillators in Asian Patients With Heart Failure.

Implantable cardioverter defibrillators (ICDs) are lifesaving devices for patients with heart failure (HF) and reduced ejection fraction. However, utilization and determinants of ICD insertion in Asia are poorly defined. We determined the utilization, associations of ICD uptake, patient-perceived barriers to device therapy and, impact of ICDs on mortality in Asian patients with HF. Using the prospective ASIAN-HF (Asian Sudden Cardiac Death in Heart Failure) registry, 5276 patients with symptomatic HF and reduced ejection fraction (HFrEF) from 11 Asian regions and across 3 income regions (high: Hong Kong, Japan, Korea, Singapore, and Taiwan; middle: China, Malaysia, and Thailand; and low: India, Indonesia, and Philippines) were studied. ICD utilization, clinical characteristics, as well as device perception and knowledge, were assessed at baseline among ICD-eligible patients (EF ≤35% and New York Heart Association Class II-III). Patients were followed for the primary outcome of all-cause mortality. Among 3240 ICD-eligible patients (mean age 58.9±12.9 years, 79.1% men), 389 (12%) were ICD recipients. Utilization varied across Asia (from 1.5% in Indonesia to 52.5% in Japan) with a trend toward greater uptake in regions with government reimbursement for ICDs and lower out-of-pocket healthcare expenditure. ICD (versus non-ICD) recipients were more likely to be older (63±11 versus 58±13 year; P<0.001), have tertiary (versus ≤primary) education (34.9% versus 18.1%; P<0.001) and be residing in a high (versus low) income region (64.5% versus 36.5%; P<0.001). Among 2000 ICD nonrecipients surveyed, 55% were either unaware of the benefits of, or needed more information on, device therapy. ICD implantation reduced risks of all-cause mortality (hazard ratio, 0.71; 95% confidence interval, 0.52-0.97) and sudden cardiac deaths (hazard ratio, 0.33; 95% confidence interval, 0.14-0.79) over a median follow-up of 417 days. ICDs reduce mortality risk, yet utilization in Asia is low; with disparity across geographic regions and socioeconomic status. Better patient education and targeted healthcare reforms in extending ICD reimbursement may improve access. URL: https://clinicaltrials.gov/ct2/show/NCT01633398. Unique identifier: NCT01633398.

Quality of life in patients with implantable cardioverter-defibrillator: systematic review of randomized controlled trials.

Implantable cardioverter-defibrillator (ICD) therapy significantly improves the survival of patients who are at high risk for sudden cardiac death. However, it is unclear whether this survival is accompanied by impairment on quality of life (QoL). This systematic review sought to describe whether ICD therapy, as compared with standard treatment, can have an impact on QoL outcomes. Extensive literature searches were carried out in PubMed, EMBASE, LILACS and Cochrane Library. Eligible studies were randomized controlled trials (RCTs) of ICD versus medical therapy that reported valid and reliable measures of QoL. Included studies were reviewed to determine baseline patient characteristics, mean duration of follow-up, questionnaires used to assess QoL and association between QoL scores and ICD shock therapy. Seven studies, enrolling a total of 5,701 patients, were included in this review. The analyzed trials showed conflicting results about the impact of ICD on QoL outcomes. Among the secondary prevention studies, CIDS reported a clear benefit from ICD and AVID showed no difference between ICD and amiodarone groups. Of the primary prevention trials, AMIOVIRT, MADIT II, DEFINITE, and SCD-HeFT found no evidence of impaired QoL in patients with an ICD. Evidence for an association between ICD shocks and QoL was mixed and seemed to depend on the interval between shocks and QoL assessment. There was no evidence of impaired QoL in patients with an ICD. However, ICD patients must be educated of all possible risks and benefits, including transitory declines in QoL after ICD shocks.

Impact of Implantable Cardioverter-Defibrillatorson WaitlistMortality AmongPatients Awaiting Heart Transplantation: An UNOS/OPTN Analysis.

This study sought to assess the impact of implantable cardioverter-defibrillators (ICDs) on waitlist mortality in patients listed for heart transplantation (HT). The impact of ICDs on preventing sudden cardiac death in patients awaiting HT has not been studied in large multicenter cohorts. Furthermore, whether ICDs benefit patients with a left ventricular assist device (LVAD) is unknown. Adults (age≥18 years) listed for first-time HT in the United States between January 1, 1999, and September 30, 2014, were retrospectively identified from the United Network for Organ Sharing registry. The primary predictor variable was the presence of an ICD at the time of listing. Primary outcome variable was all-cause waitlistmortality. Data on 32,599 patients (mean age 53 ± 12 years, 77% male, 70% Caucasian) were analyzed. During median follow-up of 154 days, 3,638 patients (11%) died on the waitlist (9% in ICD group vs. 15% in no-ICD group; p< 0.0001), whereas 63% underwent HT. Having an ICD at listing was associated with an adjusted 13% relative reduction in mortality (hazard ratio: 0.87; 95% confidence interval: 0.80 to 0.94). In the subgroup of patients with LVAD (n= 9,478), having an ICD was associated with an adjusted 19% relative reduction in mortality (hazard ratio:0.81; 95% confidence interval: 0.70 to 0.94). ICD use was associated with improved survival on the HT waitlist in patients with or without LVADs. These findings strengthen the current guideline recommendations of using ICDs in nonhospitalized patients awaitingHTand provide new insight into the effectiveness of ICDs on survival in LVAD-supported patients.

Abstract 18703: Impact of Implantable Cardioverter-defibrillators on Outcome of Patients With Left Ventricular Assist Devices

Background: Ventricular arrhythmias are common in patients supported by left ventricular assist devices (LVAD). However, the benefit of de-novo implantable cardiac defibrillators (ICD) in patients with LVAD is not well established. Methods/Results: The Nationwide Inpatient Sample database identified 12010 LVAD implantations from 2008 to 2012. Among these, 24.8% (n=2975) had a prior ICD while 6.8% (n=614) received an ICD at the time of LVAD implantation. An increase in the rate of ICD implantation during the study period was noted [4.1% in 2008 vs. 6.6% in 2012, p trend = 0.019; adjusted odds ratio (OR) per year= 0.839; 95% confidence interval (CI)= 0.724-0.972]. De-novo ICD implantation was independently associated with reduction in in-hospital mortality in new LVAD recipients [OR=0.141 (95% CI=0.080-0.248); p&lt;0.001]. Patients receiving ICD implants were younger (50.1 vs. 55.8 years, p&lt;0.001). Female sex was an independent negative predictor of ICD implantation [0.601 (0.429- 0.843); p=0.003] and ICD recipients were more likely to be white. Acute myocardial infarction, ventricular tachycardia, ventricular fibrillation (VF), cardiac arrest and atrial fibrillation were independent predictors (p=0.001 for VF; P&lt;0.001 for remainder) of de novo ICD implantation while the etiology of left ventricular dysfunction (ischemic vs. non-ischemic cardiomyopathy) did not predict ICD implantation [OR=0.824 (95% CI=0.593 -1.146); p=0.25]. Conclusion: De novo ICDs were implanted in a small proportion of LVAD recipients. However, it was associated with a significant reduction in in-hospital mortality.

Capsule Commentary on Al-Khatib et al., Future Research Prioritization: Implantable Cardioverter Defibrillator Therapy in Older Patients.

I mplantable cardioverter defibrillators (ICDs) have been consistently shown to reduce mortality rates in patients who survive ventricular arrhythmias or cardiac arrest (secondary prevention). In primary prevention of sudden cardiac death (SCD), the use of an ICD is recommended in selected patients with systolic heart failure (ischemic or non-ischemic cardiomyopathy with New York Heart Association [NYHA] functional class II or III and left ventricular eject fraction [LVEF]≤35 %, or post-ischemic heart disease with NYHA class I and LVEF≤30 %), receiving optimal medical therapy and with life expectancy of more than 1 year. Congestive heart failure is highly prevalent among older people and is the most common reason for hospitalization. However, this cohort of patients is underrepresented in clinical trials evaluating ICD placement as well as cardiovascular drugs. Older patients often have several comorbidities and are at higher risk of experiencing drug-related adverse effects, peri-procedural complications, and non-cardiac death. Furthermore, a recent study showed that the survival benefit associated with primary-prevention ICDs, although persisting in all age categories, declines with advancing age. Hence, there is a general need to increase the enrollment of the geriatric population in clinical trials, and specifically, to identify which older patients may benefit the most from ICDs in the primary prevention of SCD. Al-Khatib and colleagues developed a prioritized agenda for future research regarding ICD implantation in older patients. Through the engagement of 18 stakeholders representing different perspectives and a forced-ranking prioritization method, they identified 12 areas of evidence gaps, which included the safety and effectiveness of ICDs in the elderly, the outcomes associated with different ICD devices, different modes of death or predictors of SCD in the elderly, the impact of ICDs on the quality of life, patient preferences regarding ICD implantation, and the shared decision-making process. In order to reduce the waste of resources, it is crucial to clearly identify and prioritize research needs using qualitative and quantitative research methods to cover both the depth and breadth of these gaps. The research priorities identified by AlKhatib and colleagues could contribute to reducing some of the concerns in SCD prevention, but also to creating focused funding opportunities.

Impact of Implantable Cardioverter Defibrillators on Survival of Patients with Centrifugal Left Ventricular Assist Devices.

Both implantable cardioverter defibrillators (ICDs) and left ventricular assist devices (LVADs) have a positive impact on survival in the heart failure population. We sought to determine whether these positive effects on survival are additive or whether LVAD therapy supersedes ICD therapy. We analyzed survival data of patients implanted with nonpulsatile LVADs between October 2004 and March 2013. Survival in patients with ICDs (n = 64) was compared to those without ICDs (n = 36). Patients exited the study at the time of heart transplantation or death. A total of 100 patients underwent LVAD implantation during this time. Patients had a mean follow-up time of 364 ± 295 days. Death occurred in 15 (38%) patients in the no ICD group versus 18 (30%) in the ICD group. Univariate analysis demonstrated a marginal early survival benefit at up to 1 year post-LVAD implant in the ICD cohort; however, at time points greater than 1 year there was no statistically significant benefit in ICD therapy in LVAD patients (P = 0.56). Multivariate analysis did not show any significant predictor of survival. There were no patients who died of sudden cardiac death. There was no significant difference in the time to heart transplantation (443 days ± 251 no ICD vs 372 days ± 277 ICD, P = 0.37). The benefit of ICD therapy in the setting of continuous flow LVAD therapy is uncertain. Although prolonged ventricular arrhythmias (VAs) may potentially impact on patient survival, LVAD therapy is beneficial in prevention of sudden cardiac death due to VAs.

Acceptance and psychological impact of implantable defibrillators amongst adults with congenital heart disease

BackgroundThe psychological impact of implantable cardioverter defibrillators (ICDs) in adults with congenital heart disease (ACHD) has not been established. ObjectiveTo compare device acceptance, quality of life, anxiety and depression between ACHD patients with ICDs (ICD-Congenital), with pacemakers (PPM-Congenital), with no devices (No Device-Congenital) and non-ACHD patients with ICDs (ICD-Non-Congenital). MethodsA total of 147 ACHD and 46 non-ACHD patients (age 45.0±14.7 years, 56.5% males) completed the Florida Patient Acceptance Survey (FPAS), the 36-item Short Form Health Survey (SF-36) and Hospital Anxiety & Depression Scale (HADS). ResultsICD-Congenital patients (n=59) showed lower device acceptance compared to PPM-Congenital patients (n=41), p=0.04, and reported worse quality of life (p=0.001) and higher prevalence of depression (p=0.009) when compared to No Device-Congenital (n=47) patients. ICD-Congenital and ICD-Non-Congenital patients (n=46) showed similar mental and physical health, device acceptance, anxiety and depression. Within ICD-Congenital, patients with poorest device acceptance (FPAS <67, “Non-Acceptors”) showed significantly lower mental health scores (p=0.008), and higher levels of anxiety (p=0.02) and depression (p=0.01) compared to “Acceptors” (FPAS ≥67). “Non-Acceptors” were younger at survey (p=0.006), younger at ICD implantation (p=0.01) and were less likely to have received appropriate shocks (p=0.03). ConclusionYounger age and lack of appropriate ICD shocks are risk factors for poor ICD acceptance. Device acceptance is lower in adults with congenital heart disease who receive an ICD than those who receive pacemakers. Appropriate screening for anxiety and depression may be warranted for ACHD patients considered for ICD implantation or already living with ICDs.

The Impact of Technology Dependency on Device Acceptance and Quality of Life in Persons With Implantable Cardioverter Defibrillators

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 anxiety and mental health QOL between those with negative and those with positive attitudes (P < .001). Attitudes toward technology dependency is significantly associated with psychological outcomes and may explain the psychological distress in some ICD recipients. Degree of positivity toward technology dependency influences these outcomes. Research evaluating attitudes toward technology dependency and testing of interventions focusing on these attitudes is warranted.

Association Between Bilirubin and Mode of Death in Severe Systolic Heart Failure

The bilirubin level has been associated with worse outcomes, but it has not been studied as a predictor for the mode of death in patients with systolic heart failure. The Prospective Randomized Amlodipine Evaluation Study (PRAISE) cohort (including New York Heart Association class IIIB-IV patients with left ventricular ejection fraction <30%, n = 1,135) was analyzed, divided by bilirubin level: ≤0.6 mg/dl, group 1; >0.6 to 1.2 mg/dl, group 2; and >1.2 mg/dl, group 3. Multivariate Cox proportional hazards models were used to determine the association of bilirubin with the risk of sudden or pump failure death. Total bilirubin was entered as a base 2 log-transformed variable (log2 bilirubin), indicating doubling of the bilirubin level corresponding to each increase in variable value. The higher bilirubin groups had a lower ejection fraction (range 19% to 21%), sodium (range 138 to 139 mmol/L), and systolic blood pressure (range 111 to 120 mm Hg), a greater heart rate (range 79 to 81 beats/min), and greater diuretic dosages (range 86 to 110 furosemide-equivalent total daily dose in mg). The overall survival rates declined with increasing bilirubin (24.3, 31.3, and 44.3 deaths per 100 person-years, respectively, for groups 1, 2, and 3). Although a positive relation was seen between log2 bilirubin and both pump failure risk and sudden death risk, the relation in multivariate modeling was significant only for pump failure mortality (hazard ratio 1.47, 95% confidence interval 1.19 to 1.82, p = 0.0004), not for sudden death mortality (hazard ratio 1.21, 95% confidence interval 0.98 to 1.49, p = 0.08). In conclusion, an increasing bilirubin level was significantly associated with the risk of pump failure death but not for sudden death in patients with severe systolic heart failure.

The Impact of Technology Dependency on Device Acceptance and Quality of Life in Persons with Implantable Cardioverter Defibrillators

BACKGROUND: 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. OBJECTIVE: The aim of this study was to determine the impact of technology dependency on psychological outcomes in ICD recipients. METHODS: 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. RESULTS: 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 anxiety and mental health QOL between those with negative and those with positive attitudes (P < .001). CONCLUSIONS: Attitudes toward technology dependency is significantly associated with psychological outcomes and may explain the psychological distress in some ICD recipients. Degree of positivity toward technology dependency influences these outcomes. Research evaluating attitudes toward technology dependency and testing of interventions focusing on these attitudes is warranted.

Letter by Dardas and Aaronson Regarding Article, “Impact of Implantable Cardioverter-Defibrillator, Amiodarone, and Placebo on the Mode of Death in Stable Patients With Heart Failure: Analysis From the Sudden Cardiac Death in Heart Failure Trial”

HomeCirculationVol. 122, No. 15Letter by Dardas and Aaronson Regarding Article, “Impact of Implantable Cardioverter-Defibrillator, Amiodarone, and Placebo on the Mode of Death in Stable Patients With Heart Failure: Analysis From the Sudden Cardiac Death in Heart Failure Trial” Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessLetterPDF/EPUBLetter by Dardas and Aaronson Regarding Article, “Impact of Implantable Cardioverter-Defibrillator, Amiodarone, and Placebo on the Mode of Death in Stable Patients With Heart Failure: Analysis From the Sudden Cardiac Death in Heart Failure Trial” Todd F. Dardas, MD, MS and Keith D. Aaronson, MD, MS Todd F. DardasTodd F. Dardas University of Michigan Health Systems Division of Cardiovascular Medicine Ann Arbor, Mich (Dardas, Aaronson). Search for more papers by this author and Keith D. AaronsonKeith D. Aaronson University of Michigan Health Systems Division of Cardiovascular Medicine Ann Arbor, Mich (Dardas, Aaronson). Search for more papers by this author Originally published12 Oct 2010https://doi.org/10.1161/CIRCULATIONAHA.110.941302Circulation. 2010;122:e486To the Editor:The Sudden Cardiac Death in Heart FailureTrial (SCD-HeFT) investigators provide an important analysis of the mode of death that occurred in the placebo, amiodarone, and defibrillator arms of the SCD-HeFT.1 The authors conclude that survival from sudden cardiac death is increased among those randomized to an implantable cardioverter-defibrillator (ICD). In addition, the probability of survival from heart failure death was not reduced among those receiving ICD therapy.Another approach to measuring the effect of ICD therapy on the type of death is to assess the odds of the mode of death given that a death occurred. We used the data supplied in the SCD-HeFT authors' table and multinomial logistic regression to assess the odds of selected types of cardiac death relative to the odds of heart failure death. When comparing the odds of tachyarrythmic death to heart failure death, the odds of a tachyarrythmic death were higher in the placebo [odds ratio 2.8, 95% confidence interval 1.7–4.6] and amiodarone (odds ratio 2.2, 95% confidence interval 1.3–3.6) groups compared with the ICD group. The modeled probability of a cardiac death being a heart failure death over the course of the study was 59% in the ICD group versus 41% in the amiodarone group and 40% in the placebo groups. The probability of tachyarrythmic deaths was 30% for the ICD group, 46% for the amiodarone group, and 57% for the placebo group. From the standpoint of the type of death, given that a death occurred, we can conclude that heart failure deaths are more frequent in the ICD group.From the SCD-HeFT authors' analysis, we may conclude that ICD therapy does not alter survival from heart failure deaths, in contrast to observations that ICD placement may reduce overall mortality while increasing heart failure deaths. ICDs certainly do not hasten death from heart failure, but ICDs will allow more patients to be exposed to the baseline risk of heart failure death. This effect is well visualized in the mode of death curves reported in the Defibrillator in Acute Myocardial Infarction Trial (DINAMIT), which shows that when arrhythmic deaths are censored, the likelihood of nonarrhythmic deaths in the ICD arm increases relative to the control arm.2 Censoring sudden death has the effect of overestimating mortality from heart failure death. Simultaneously, more patients in the ICD arm are exposed to pump failure death as the result of sudden death reduction. Because ICDs are effective in reducing sudden death, the effect of increasing the number of subjects at risk for pump failure death in the ICD arm is greater than the overestimate of mortality from censoring sudden death in the control arm. As such, we would expect that pump failure deaths in the ICD arm would exceed those in the control arm. ICDs introduce no excess risk of pump failure, although among those who die, heart failure deaths are relatively more likely among those with an ICD.Todd F. Dardas, MD, MSKeith D. Aaronson, MD, MS University of Michigan Health Systems Division of Cardiovascular Medicine Ann Arbor, Mich.DisclosuresNone.