Clinical characteristics and outcomes of elderly patients treated with an implantable cardioverter-defibrillator or cardiac resynchronization therapy in a real-world setting: Data from the Israeli ICD Registry

doi:10.1016/j.hrthm.2013.12.003

Heart Rhythm

Volume 11, Issue 3, March 2014, Pages 435-441

https://doi.org/10.1016/j.hrthm.2013.12.003 Get rights and content

Background

Elderly patients are underrepresented in clinical trials of device therapy.

Objective

To provide real-world data regarding outcomes associated with device-based therapy in a large cohort of elderly patients enrolled in the Israeli ICD Registry.

Methods

Between July 2010 and June 2012, a total of 2807 consecutive patients undergoing implanted cardioverter-defibrillator/cardiac resynchronization therapy-defibrillator (ICD/CRT-D) implantation were prospectively enrolled in the Israeli ICD Registry. For the present analysis, patients were categorized into 3 age groups: ≤60 years (n = 1378 [49%]), 61–75 years (n = 863 [31%]), and >75 years (n = 566 [20%]).

Results

Elderly patients (>75 years of age) had more comorbid conditions and were more likely to undergo CRT-D implantation (all P < .01). However, the rate of device-related complications associated with surgical reinterventions at 1 year was <3% regardless of age (P = .70 for the comparison among the 3 age groups). Multivariate analysis showed that the risk of heart failure or death and of appropriate ICD therapy for ventricular arrhythmias was significantly increased with increasing age among patients who received an ICD. In contrast, the age-related increase in the risk of all end points was attenuated among patients who received CRT-D devices (all P values for age-by-device–type interactions are <.05).

Conclusions

In a real-world scenario, elderly patients (>75 years of age) comprise approximately 20% of the ICD/CRT-D recipients and experience a device reintervention rate similar to that of their younger counterparts. Our data suggest that the association between advanced age and adverse clinical outcomes is attenuated in elderly patients implanted with CRT-D devices.

Introduction

Randomized controlled trials have demonstrated the effectiveness of implanted cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy-defibrillators (CRT-Ds) for improved survival.1, 2, 3, 4, 5 Therefore, ICD treatment has become standard therapy for primary and secondary prevention of sudden cardiac death (SCD) in patients with increased risk of ventricular arrhythmias (VA), as indicated by the guideline recommendations.⁶ Elderly patients (eg, aged ≥75 or 80 years) and patients with major comorbidities, however, were excluded from some of the major ICD trials, and a few patients aged >75 years were enrolled in any of the studies.

In the face of competing risks and the absence of any randomized clinical trial data, it is not known, therefore, what survival benefit elderly patients derive from device-based therapy. Retrospective studies, such as that conducted by Groeneveld et al,⁷ have associated ICD therapy (as compared with standard medical therapy) with a significant decrease in mortality rates in elderly patients implanted for primary prevention hospitalized for congestive heart failure (HF). In contrast, in a recent meta-analysis of major clinical trials of ICDs vs standard medical therapy for the primary prevention of SCD in patients with severe left ventricular (LV) dysfunction, the survival benefit after ICD placement was not statistically significant in elderly patients.⁸ Given the increasing age of the overall patient population, it is important to understand the outcomes of elderly patients who receive device-based therapy. Furthermore, it is currently unknown whether CRT provides incremental benefits in the older age group. Accordingly, the purpose of the present study was to evaluate, in a “real-world” scenario, the outcomes of elderly patients who received device-based therapy (ICD or CRT-D) in the Israeli ICD Registry. Specifically, we aimed to compare age-related effects on outcomes after ICD vs CRT-D implantation.

Section snippets

Design and participants

The Israeli ICD Registry is a prospective registry of all patients undergoing implantation or replacement of an ICD or CRT-D in all 22 implanting centers in the country. The registry is a collaborative effort between the community of cardiac electrophysiologists, care providers, industry, and payers and is managed by the Israeli Association for Cardiovascular Trials (I-ACT). The registry was approved by the ethics committee of each participating institution, and all patients provided written

Patient population

From July 2010 through June 2012, a total of 2807 patients underwent first-time ICD or CRT-D implantation at 22 centers in Israel. Baseline demographic and clinical characteristics data stratified according to age category are listed in Table 1. Elderly patients (aged >75 years) accounted for 20% of all ICD/CRT-D implants, were more likely to be of Jewish rather than Arab origin, and to have their device implanted for secondary prevention reasons. As age increased across the 3 study-defined

Discussion

Although the elderly population is growing in Western countries, the early ICD/CRT-D randomized controlled trials, which included patients with a mean age of 55–65 years, are not representative of the elderly population.1, 3, 5 The Israeli ICD Registry is unique in that it captures nearly all patients undergoing ICD or CRT-D in Israel and in its prospective nature with detailed longitudinal follow-up. The Israeli ICD Registry is, therefore, an excellent representative of the nationwide ICD

Conclusions and clinical implications

In a real-world scenario, elderly patients (aged >75 years) comprise approximately 20% of the ICD/CRT-D recipients and experience a device reintervention rate similar to that of their younger counterparts. Our findings extend prior data and suggest an important role for CRT in the older age group.

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Cited by (27)

Contributions of Israel to the field of clinical cardiac electrophysiology and implantable devices
2024, Heart Rhythm O2
Cardiac Implantable Electronic Devices: Reoperations and the Competing Risk of Death
2022, Heart Lung and Circulation
Citation Excerpt :
Another study in patients with ICDs and CRT-Ds found that the rate of defibrillator shocks and anti-tachycardia pacing decreased with increasing age, concluding that there were less benefits of ICD therapy in older than in younger patients because of the higher mortality [14]. Considering the high mortality, cost of the procedures, complication rates associated with implantation procedures [22], and that ICD has been found to have an adverse effect on quality of life with reduction in physical activity and increased shock anxiety [23,24], implantation and reoperation of defibrillators in older patients should be given careful considerations [12,21,25–27]. Studies with population-based person-level estimates on the use of CIEDs over time for Australia report that in the period 1995–2009, the incidence of pacemaker insertions increased from 32 to 53 per 100,000, the highest incidence was found in those aged 85 years or older [28].
The use of cardiac implantable electronic devices (CIED), which includes pacemakers, implantable cardioverter-defibrillators (ICD), cardiac resynchronisation therapy pacemakers (CRT-P) and cardiac resynchronisation therapy defibrillators (CRT-D) has increased over the past 20 years, but there is a lack of real world evidence on the longevity of these devices in the older population which is essential to inform health care delivery and support clinical decisions.
We conducted a retrospective cohort study using data from the Australian Government Department of Veterans’ Affairs database. The cohort consisted of people who had a CIED procedure between 2005 and 2015. The cumulative risk of generator replacement/reoperations was estimated accounting for the competing risk of death. A total of 16,662 patients were included. In pacemaker recipients with an average age of 85 years, the 5-year risk of reoperation ranged from 2.8% in single chamber, 3.6% in dual chamber to 7.6% in CRT-P recipients, while the 5-year risk of dying with the index pacemaker in situ was 63% in single chamber, 46% in dual chamber and 56% in CRT-P recipients. In defibrillator recipients with an average age of 80 years, the 5-year risk of reoperation ranged from 11% in single chamber, 13% in dual chamber to 24% in CRT-D recipients, while the 5-year risk of dying with the index defibrillator in situ was 46% in single chamber, 40% in dual chamber and 41% in CRT-D recipients.
In this cohort of older patients the 5-year risk of generator reoperation was low in pacemaker recipients whereas up to one in four CRT-D recipients would have a reoperation within 5 years.
Heart failure treatment in patients with cardiac implantable electronic devices: Opportunity for improvement
2021, Heart Rhythm O2
Citation Excerpt :
MRA use was infrequently reported, being 45% (32%–61%) in CRT studies and 59% in a single ICD trial. Baseline medical therapy in major registries and cohort studies of CRT and ICD (n = 19) is presented in Figure 3.30–48 CRT studies reported ACEI/ARB and beta-blocker baseline use in 78% (52%–100%) and 80% (70%–87%).
Heart failure and reduced ejection fraction (HFrEF) is the predominant indication for cardiac resynchronization therapy (CRT) and implantable cardioverter-defibrillator (ICD) implantation. The care gap and opportunity to optimize guideline-directed medical therapy (GDMT) is unclear.
We sought to define uptake, eligibility, dose, and adherence to GDMT in patients with CRT/ICD and HFrEF.
MEDLINE was searched from 2000 to July 2021 for major randomized trials, registries, and cohort studies evaluating GDMT in this population. Thirty-eight studies focused on medical therapy in patients with CRT/ICD devices (CRT = 23, ICD = 11, and both = 4).
In the pivotal device trials, ACEI/ARB and beta-blocker use was high (mean 94%, range 41%–99%; and 83%, range 27%–97%, respectively), but mineralocorticoid receptor antagonists were modest (mean 45%, range 32%–61%), in keeping with guidelines of that era. Similar results were found in observational registries. CRT was associated with beta-blocker uptitration, while the effects on ACEI/ARB were less consistent. For beta blockers, 57%–68% of patients were uptitrated, increasing the mean percent of target dose achieved by 24% from baseline to follow-up. In one study, adherence increased, for ACEI/ARB from 37% to 55% and beta blockers 34% to 58%. Only 1 study assessed potential eligibility at implant for sacubitril-valsartan (72%) or ivabradine (28%), and no study examined sodium-glucose cotransporter-2 inhibitors. Increased uptake, titration, and dose was associated with reduced mortality, hospitalization, and device therapies.
Patients with HFrEF and ICD/CRT are undertreated with respect to GDMT, and there is opportunity to optimize therapy to improve morbidity and mortality.
Mode of Death in Octogenarians Treated With Cardiac Resynchronization Therapy
2016, Journal of Cardiac Failure
Cardiac resynchronization therapy (CRT) improves morbidity and mortality in heart failure with reduced ejection fraction (HFrEF) and electrical dyssynchrony. CRT patients in clinical practice are older compared with clinical trials.
To investigate clinical response, reverse remodeling, outcome, and mode of death in octogenarians receiving CRT.
Baseline characteristics, change in New York Heart Association (NYHA) functional class, reverse ventricular remodeling, heart failure readmissions, all-cause mortality, and mode of death were evaluated in CRT patients with comparison between octogenarians and nonoctogenarians. In addition, annual mortality rates of octogenarians undergoing CRT were compared with age-matched control subjects from the general population with the use of national actuarial tables.
A total of 686 patients, including 178 octogenarians (26%), were followed for 38 ± 22 months. Octogenarians exhibited a similar change in NYHA functional class (P = .640), left ventricular ejection fraction increase (P = .796), and decrease in end-diastolic (P = .441) and end-systolic (P = .312) diameter compared with their younger counterparts undergoing CRT. Octogenarians had a higher all-cause mortality risk (P < .001), but heart failure readmission risk did not differ (hazard ratio 0.916, 95% confidence interval 0.638–1.313; P = .632). A higher proportion of noncardiac deaths was observed in octogenarians (74%) versus younger patients (50%; P = .022), with worsening heart failure rather than malignant tachyarrhythmia being the main cardiac cause of death. Compared with an age-matched sample from the general population, octogenarians receiving CRT had an equivalent annual mortality rate (log-rank test: P = .444).
Octogenarians retain the ability to mount a significant symptomatic and ventricular remodeling response after CRT, resulting in survival similar to the general age-matched population.
Position paper for management of elderly patients with pacemakers and implantable cardiac defibrillators: Groupe de Rythmologie et Stimulation Cardiaque de la Société Française de Cardiologie and Société Française de Gériatrie et Gérontologie
2016, Archives of Cardiovascular Diseases
Citation Excerpt :
Many randomized studies have reported divergent results regarding the benefit of ICDs in the elderly [1,16,19,122]. Because of the under-representation of elderly patients in randomized trials, observational studies with small samples in single centres and national registries investigated the efficacy of ICD in elderly patients and, similarly, yielded inconsistent results [111,117,123,124]. Recently, one of the largest longitudinal registries of ICD implantation for primary prevention of SCD in a “real life” French cohort of elderly patients, with an age-stratified analysis, suggested a similar benefit in those patients concerning the risk of SCD: older patients exhibited higher global mortality, whereas the rates of SCD and appropriate device therapies were similar for the different age groups [115].
Despite the increasingly high rate of implantation of pacemakers (PMs) and implantable cardioverter defibrillators (ICDs) in elderly patients, data supporting their clinical and cost-effectiveness in this age stratum are ambiguous and contradictory. We reviewed the data regarding the applicability, safety and effectiveness of conventional pacing, ICDs and cardiac resynchronization therapy (CRT) in elderly patients. Although periprocedural risk may be slightly higher in the elderly, the implantation procedure for PMs and ICDs is still relatively safe in this age group. In older patients with sinus node disease, the general consensus is that DDD pacing with the programming of an algorithm to minimize ventricular pacing is preferred. In very old patients presenting with intermittent or suspected atrioventricular block, VVI pacing may be appropriate. In terms of correcting potentially life-threatening arrhythmias, the effectiveness of ICD therapy is similar in older and younger individuals. However, the assumption of persistent ICD benefit in the elderly population is questionable, as any advantageous effect of the device on arrhythmic death may be attenuated by higher total non-arrhythmic mortality. While septuagenarians and octogenarians have higher annual all-cause mortality rates, ICD therapy may remain effective in selected patients at high risk of arrhythmic death and with minimum comorbidities despite advanced age. ICD implantation among the elderly, as a group, may not be cost-effective, but the procedure may reach cost-effectiveness in those expected to live more than 5–7 years after implantation. Elderly patients usually experience significant functional improvement after CRT, similar to that observed in middle-aged patients. Management of CRT non-responders remains globally the same, while considering a less aggressive approach in terms of reinterventions (revision of left ventricular [LV] lead placement, addition of a right ventricular or LV lead, LV endocardial pacing configuration). Overall, physiological age, general status and comorbidities rather than chronological age per se should be the decisive factors in making a decision about device implantation selection for survival and well-being benefit in elderly patients.
Malgré le taux de plus en plus élevé d’implantation de pacemaker (PM) ou de défibrillateurs automatiques implantables (DAI) chez les patients âgés, l’efficacité clinique et le rapport coût/efficacité des prothèses électriques dans cette population restent discutés. Nous discutons ici les données concernant l’applicabilité, la sécurité et l’efficacité de la stimulation conventionnelle, du DAI et de la resynchronisation cardiaque chez les patients âgés. Le risque péri-procédural peut être légèrement plus élevé chez les personnes âgées, mais l’implantation de PM ou de DAI se fait avec une relative sécurité pour ces patients. Chez les patients âgés souffrant d’une maladie du nœud sinusal, un consensus général est que la stimulation double chambre, ainsi que la programmation d’un algorithme pour réduire au minimum la stimulation ventriculaire est préférable. Pour les patients très âgés avec un bloc atrioventriculaire intermittent ou suspecté, la stimulation VVI peut être appropriée. Concernant les arythmies ventriculaires potentiellement mortelles, l’efficacité du traitement par DAI est comparable chez les personnes âgées et les sujets plus jeunes. Toutefois, l’hypothèse d’un bénéfice du DAI dans la population âgée est discutable, car le bénéfice sur la mort arythmique peut être atténué par une mortalité totale ou non rythmique supérieure. Alors que septuagénaires et octogénaires ont des taux annuels plus élevés de mortalité totale, le traitement par DAI peut rester efficace chez certains patients à haut risque de décès par arythmie et avec des comorbidités limitées malgré l’âge avancé. L’implantation de DAI chez les personnes âgées peut avoir un rapport coût/efficacité défavorable à l’échelle de la population totale, mais la procédure est économiquement rentable si l’on considère les patients avec une espérance de vie d’au moins 5–7 ans après l’implantation. Les patients âgés ont habituellement une amélioration fonctionnelle significative après resynchronisation cardiaque par stimulation biventriculaire, similaire à celle observée chez les patients d’âge moyen. La prise en charge des non répondeurs à la resynchronisation reste globalement la même, tout en tenant compte d’une approche moins agressive en termes de ré-interventions (repositionnement de sonde VG, ajout d’une sonde VD ou VG, ou stimulation endocardique VG). Au total, l’âge physiologique, le statut général et les comorbidités (plutôt que l’âge chronologique en soi) devraient être les facteurs décisifs lors de prise de décision pour l’implantation d’une prothèse cardiaque électrique pour un bénéfice en termes de survie et de qualité de vie chez les patients âgés.
Does Age Influence Cardiac Resynchronization Therapy Use and Outcome?
2015, JACC: Heart Failure
Citation Excerpt :
We found that a large fraction of CRT-D (39%) were implanted in patients 75 years old or older. This fraction of those receiving CRT in older adults was similar to those in the PREMIER registry (22% of CRT-D implants age ≥80 years) and single-center data from the Netherlands (44% age ≥70 years) (14) and Belgium (22% age ≥80 years) (11) but higher than that in a national registry from Israel (20% age ≥75 years) (15). Our study did not include patients receiving CRT without a defibrillator (CRT-P).
This study sought to describe the use of CRT-D and its association with survival for older patients.
Many patients who receive cardiac resynchronization therapy with defibrillator (CRT-D) in practice are older than those included in clinical trials.
We identified patients undergoing ICD implantation in the National Cardiovascular Disease Registry (NCDR) ICD registry from 2006 to 2009, who also met clinical trial criteria for CRT, including left ventricular ejection fraction (LVEF) ≤35%, QRS ≥120 ms, and New York Heart Association (NYHA) functional class III or IV. NCDR registry data were linked to the social security death index to determine the primary outcome of time to death from any cause. We identified 70,854 patients from 1,187 facilities who met prior trial criteria for CRT-D. The mean age of the 58,147 patients receiving CRT-D was 69.4 years with 6.4% of patients age 85 or older. CRT use was 80% or higher among candidates in all age groups. Follow-up was available for 42,285 patients age ≥65 years at 12 months.
Receipt of CRT-D was associated with better survival at 1 year (82.1% vs. 77.1%, respectively) and 4 years (54.0% vs. 46.2% , respectively) than in those receiving only an ICD (p < 0.001). The CRT association with improved survival was not different for different age groups (p = 0.86 for interaction).
More than 80% of older patients undergoing ICD implantation who were candidates for a CRT-D received the combined device. Mortality in older patients undergoing ICD implantation was high but was lower for those receiving CRT-D.

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: The first 2 authors contributed equally to this work.

: This study was supported by an unrestricted research grant from Boston Scientific to the Israeli Heart Society and the Israeli Association for Cardiovascular Trials.

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Clinical characteristics and outcomes of elderly patients treated with an implantable cardioverter-defibrillator or cardiac resynchronization therapy in a real-world setting: Data from the Israeli ICD Registry

Background

Objective

Methods

Results

Conclusions

Introduction

Section snippets

Design and participants

Patient population

Discussion

Conclusions and clinical implications

Heart Rhythm

J Am Coll Cardiol

J Am Coll Cardiol

Int J Cardiol

J Am Coll Cardiol

Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure

N Engl J Med

Meta-analysis of the implantable cardioverter defibrillator secondary prevention trials. AVID, CASH and CIDS studies. Antiarrhythmics vs Implantable Defibrillator study. Cardiac Arrest Study Hamburg. Canadian Implantable Defibrillator Study

Eur Heart J

Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy

N Engl J Med

Multicenter Automatic Defibrillator Implantation Trial Investigators. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia

N Engl J Med

Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction

N Engl J Med