Complications and 1-year benefit of cardiac resynchronization therapy in patients over 75 years of age — Insights from the German Device Registry

doi:10.1016/j.ijcard.2016.11.212

International Journal of Cardiology

Volume 228, 1 February 2017, Pages 784-789

https://doi.org/10.1016/j.ijcard.2016.11.212 Get rights and content

Abstract

Objective

Evidence on cardiac resynchronization therapy (CRT) in older patients is scarce and conflicting. Nevertheless, CRT in the elderly is of major practical relevance as heart failure prevalence increases with age.

Methods

The German Device Registry (DEVICE) is a nationwide, prospective registry with a longitudinal follow-up design investigating device implantations in 60 German centres. The present analysis of DEVICE focussed on perioperative complication rates and 1-year outcome of patients ≥ 75 years (n = 320) compared to younger patients (n = 879) receiving a CRT device.

Results

Comorbidities were more common in older patients (chronic kidney disease (CKD): 27.5% vs. 21.5%, p = 0.029; atrial fibrillation (AF): 26.9% vs. 15.6%, p < 0.001). Despite higher NYHA classes in the older age group, ejection fractions were comparable (27.2 ± 7.1% ≥ 75 years, 26.2 ± 7.1% < 75 years, p = 0.06). Perioperative complications and mortality rates did not show significant difference between groups. After new device implantation, absolute 1-year mortality was higher in older patients (11.0% ≥ 75 years, 6.4% < 75 years, p = 0.014), with a significantly lower proportion of cardiac deaths in the older group (p = 0.05). Patients ≥ 75 years being alive after 1 year had lower response rates, with chronic kidney disease (OR 0.46, p < 0.05) and smaller QRS complexes (OR 0.31, p < 0.01) being particular risk factors for missing improvement of heart failure symptoms. As expected severe heart failure (NYHA IV) was a strong independent predictor of death (HR 1.95, p = 0.01), whereas AF as underlying rhythm could be worked out as predictor for mortality especially in the younger patients (HR 2.31, p = 0.002).

Conclusions

Patients ≥ 75 years of age receiving a CRT device do not have a higher perioperative mortality and complication rate although comorbidities (CKD and AF) occur more frequently. The absolute 1-year mortality is higher; nevertheless, the proportion of cardiac deaths is even lower in the older patients reflecting a benefit of CRT in this group.

Introduction

It is well known that the prevalence of congestive heart failure (CHF) increases with age. Epidemiologic studies even reported increasing incidence of CHF in older patients over the past decades [1] probably reflecting improved interventional and medical therapies. Several large randomized controlled trials have shown that cardiac resynchronization therapy (CRT) provides a reduction in heart failure symptoms and related mortality [2], [3]. Therefore, CRT is an established therapy for patients with heart failure symptoms, reduced ejection fraction, and wide QRS complexes [4] irrespective of age. With aging population and increased discussion about health system resources, cost-intensive CRT in the elderly is of major practical concern. Recently, a large analysis of CRT use in the United States revealed a high provision of CRT over all age groups [5] with 80% of patients ≥ 85 years receiving a CRT-D if eligible. Nevertheless, older patients are underrepresented in large CRT trials and evidence of CRT benefit and complications is limited in the older age group. Retrospective substudies of large trials suggest a similar benefit for older patients [6]. Other studies reveal a higher mortality in octogenarians mostly caused by non-cardiac comorbidities attenuating the benefit [7]. With regard to the limited and conflicting evidence, further observation of older patients with CRT devices seems mandatory. Therefore, the present comparison between patients < 75 years of age and patients ≥ 75 years from the German Device Registry focuses on perioperative complications and outcome after 1 year. In terms of 1-year benefit we aimed at identifying factors influencing response to therapy as DEVICE provides thorough information on comorbidities.

Section snippets

Recruitment and follow-up

The German Device Registry is a nationwide, prospective database of ICD or CRT implants and revisions initiated by the Institute of Research in Myocardial Infarction (Stiftung Institut für Herzinfarktforschung Ludwigshafen, Germany (IHF)). In 60 participating centres over 70 parameters on demographic data, indication for the device, implantation procedure, and perioperative complications have been collected at the time of device operation. Recruitment of patients for the German Device Registry

Patient characteristics/demography

Out of 1199 patients (pat) with a CRT device included in DEVICE 320 pat ≥ 75 years (26.7%) were compared to 879 pat younger than 75 years (73.3%). 7.9% (n = 95) were ≥ 80 years of age. Inclusion criteria into DEVICE was a revision of CRT device in 18.8% of pat ≥ 75 years and 20.8% of patients < 75 years (p = 0.43). Coronary artery disease (CAD) was the predominant underlying cardiac disease and more likely in older pat (59.4% ≥ 75 years vs. 49.0% < 75 years, p = 0.002) whereas dilated cardiomyopathy (DCM)

Discussion

The major findings of the present comparison between patients ≥ 75 years of age and younger receiving CRT implantation from the large German Device Registry are:

[1] Older patients presenting for CRT implantation have at least equal LV ejection fractions, but worse NYHA classes reflecting the higher amount of comorbidities. [2] Despite comorbidities peri- and postoperative complication rates are not higher in the older patients. [3] 1-year total mortality is significantly higher in the older age

Limitations

We acknowledge some major limitations of the present study. The registry design itself has known limitations as selection and information bias may occur despite the more generalized inclusion of patients compared to randomized trials. In terms of data acquisition a variety of comorbidities and ECG criteria were assessed; nevertheless, parameters were not validated profoundly (e.g. acquisition of serum creatinine instead of glomerular filtration rate, no differentiation of

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Cited by (11)

Complications and Mortality Following CRT-D Versus ICD Implants in Older Medicare Beneficiaries With Heart Failure
2022, JACC: Heart Failure
Citation Excerpt :
This is problematic because relevant professional guidelines consistently recommend ICD (with or without CRT) only when life expectancy is at least 1 year (19), but estimating survival is notoriously unreliable and is commonly based on clinical gestalt. This is particularly true in the oldest patients, for whom clinical trial data are absent and estimates of mortality from observational studies are widely variable (7,31,32). Estimating competing mortality risk may be exacerbated by a dispersed medical system in which the severity and burden of noncardiovascular disease in a specific patient may be difficult or impossible for an implanting physician to ascertain.
This study sought to assess the comparative effectiveness of cardiac resynchronization therapy with defibrillator (CRT-D) over implantable cardioverter-defibrillator (ICD) alone in older Medicare patients with heart failure with reduced ejection fraction (HFrEF).
Despite growing numbers of older patients with HFrEF, the benefits of cardiac resynchronization therapy (CRT) in this group are largely unknown.
A cohort of fee-for-service Medicare beneficiaries ≥65 years of age with HFrEF and enrolled in Medicare Part D who underwent CRT-D or ICD implantation from January 2008 to August 2015 was identified. Beneficiaries were divided by age (65-74, 75-84, and 85+ years), and outcomes were compared between the CRT-D and ICD groups after inverse probability weighting.
Compared with the ICD group, the CRT-D group was older and more likely to be White, be female, and have left bundle branch block. After weighting, overall complications were high across age and device groups (14%-20%). The 1-year mortality was high across all groups. In the 2 oldest age strata, the hazard of death was lower in the CRT-D group (HR: 0.90; 95% CI: 0.86-0.95 and HR: 0.81; 95% CI: 0.72-0.90, respectively; P < 0.001); the hazard of heart failure hospitalization was lower for CRT-D vs ICD in the 85+ years age group (HR: 0.82; 95% CI: 0.74-0.92; P < 0.001).
In older Medicare beneficiaries undergoing ICD with or without CRT, complications and 1-year mortality were high. Compared with ICD alone, CRT-D was associated with a lower hazard of mortality in patients ≥74 years of age and lower hazard of HF hospitalization in those ≥85 years of age. These findings support the use of CRT in eligible older patients undergoing ICD implantation.
Comparative effectiveness of cardiac resynchronization therapy in older patients with heart failure: Systematic review and meta-analysis
2022, Journal of Cardiac Failure
Pivotal CRT trials enrolled patients with HFrEF significantly younger than the typical contemporary patient with HFrEF. Thus, the risks and benefits in this older population with HFrEF are largely unknown. We sought to perform meta-analyses comparing safety and effectiveness of cardiac resynchronization therapy (CRT) in older vs younger patients with heart failure with reduced ejection fraction (HFrEF).
PubMed, The Cochrane Library, Scopus, and Web of Science were queried for comparative effectiveness studies of CRT in older patients with HFrEF. Title, abstract, and full-text screening was performed to identify studies comparing at least 1 prespecified end point between older and younger adult patients with at least 50 participants. Random effects meta-analysis in the left ventricular ejection fraction (LVEF) mean difference (older minus younger) and the relative risk (RR) of death, improvement in New York Heart Association (NYHA) functional class, and complications are reported along with estimates of heterogeneity. In 7 studies, there was similar LVEF improvement between groups (mean difference 1.14, 95% confidence interval [CI] –0.04 to 2.32, P = .06, I² = 53%). Older patients were equally likely as younger patients to see an improvement in NYHA functional class of at least 1 in 6 studies (RR 0.99, 95% CI 0.93–1.06, P = .76, I² = 25%). No significant differences in the incidence of hematoma, pneumothorax, lead dislodgment, cardiac perforation, or infection requiring explant was observed. The RR of mortality in 11 studies demonstrated higher risk of all-cause mortality in older patients (RR 1.05, 95% CI 1.03–1.08, P < .01, I² = 0%).
Compared with younger patients, older patients receiving CRT were equally likely to experience improvement in LVEF, left ventricular end-diastolic diameter, and NYHA functional class. There was no difference in procedural complications. The higher rate of all-cause mortality in older patients likely reflects a greater underlying risk of death from competing causes.
Distribution and impact of age in patients with implantable cardioverter-defibrillators regarding early complications and 1-year clinical outcome: results from the German Device Registry
2021, Journal of Interventional Cardiac Electrophysiology
Novel two-lead cardiac resynchronization therapy system provides equivalent CRT responses with less complications than a conventional three-lead system: Results from the QP ExCELs lead registry
2020, Journal of Cardiovascular Electrophysiology
Impact of diabetes on clinical outcome of patients with heart failure undergoing ICD and CRT procedures: results from the German Device Registry
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Implantable cardioverter defibrillators in patients with electrical heart disease and hypertrophic cardiomyopathy: data from the German device registry
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View full text

Complications and 1-year benefit of cardiac resynchronization therapy in patients over 75 years of age — Insights from the German Device Registry

Abstract

Objective

Methods

Results

Conclusions

Introduction

Section snippets

Recruitment and follow-up

Patient characteristics/demography

Discussion

Limitations

JACC Heart Fail.

Am. J. Cardiol.

Am. J. Cardiol.

J. Am. Coll. Cardiol.

Epidemiology of heart failure

Circ. Res.

Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure

N. Engl. J. Med.

An individual patient meta-analysis of five randomized trials assessing the effects of cardiac resynchronization therapy on morbidity and mortality in patients with symptomatic heart failure

Eur. Heart J.

2013 ESC guidelines on cardiac pacing and cardiac resynchronization therapy: the task force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA)

Eur. Heart J.

Improved outcome with preventive cardiac resynchronization therapy in the elderly: a MADIT-CRT substudy

J. Cardiovasc. Electrophysiol.

Clinical outcomes in cardiac resynchronization therapy-defibrillator recipients 80 years of age and older

Europace