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A New Single Chamber Implantable Defibrillator with Atrial Sensing: A Practical Demonstration of Sensing and Ease of Implantation
Published on: February 28, 2012
Implantable Cardioverter-Defibrillator and Frailty in Non-ischemic Heart Failure With Reduced Ejection Fraction:
Jawad H Butt1, Johan Skovgaard Bundgaard2, Morten Schou3
1Department of Cardiology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark; Department of Cardiology, Zealand University Hospital, Roskilde, Denmark.
Insights
Frailty did not significantly alter the effectiveness of implantable cardioverter-defibrillators (ICDs) for preventing death in patients with heart failure. However, the necessity of ICDs in frail heart failure patients receiving optimal medical therapy remains unclear.
Area of Science:
- Cardiology
- Geriatrics
- Clinical Trials
Background:
- Patients with frailty often have a perceived unfavorable risk/benefit profile for therapies.
- Implantable cardioverter-defibrillators (ICDs) are used for primary prevention of sudden cardiac death in heart failure.
- The impact of frailty on ICD effectiveness requires further investigation.
Purpose of the Study:
- To examine the long-term effects of primary prevention ICDs compared to usual care based on frailty status.
- To assess if frailty modifies the benefit of ICDs in patients with nonischemic heart failure with reduced ejection fraction (HFrEF).
Main Methods:
- Extended follow-up of the Danish Study to Assess the Efficacy of ICDs in Patients with nonischemic Systolic Heart failure on Mortality (DANISH) trial.
- Frailty assessed using the Rockwood cumulative deficit approach, categorized into three classes.
- Primary outcome: all-cause death; secondary outcomes: cardiovascular death and sudden cardiovascular death.
Main Results:
- Frailty was present in 68.3% of patients (classes 2 and 3).
- ICD implantation did not significantly vary in effect on all-cause death or cardiovascular death across frailty classes (Pinteraction = 0.99 and 0.94, respectively).
- A potential increased benefit of ICDs for sudden cardiovascular death was observed in more frail patients (Pinteraction = 0.03), but this was not significant when frailty index was analyzed continuously.
Conclusions:
- Frailty did not significantly modify the effects of primary prevention ICDs compared to usual care in patients with nonischemic HFrEF.
- The benefit of ICDs on sudden cardiovascular death may be greater in more frail individuals, but this requires further study.
- The need for primary prevention ICDs in frail HFrEF patients receiving contemporary guideline-directed medical therapy remains uncertain.
Abstract:
Patients with frailty are often perceived to have a less favorable risk/benefit profile for pharmacological and device-based therapies. We examined the long-term effects of a primary prevention implantable cardioverter-defibrillator (ICD), compared with usual care, according to frailty status in an extended follow-up study of the Danish Study to Assess the Efficacy of ICDs in Patients with nonischemic Systolic Heart failure on Mortality (DANISH) trial. The DANISH trial randomized 1,116 patients with nonischemic heart failure with reduced ejection fraction (HFrEF) to ICD implantation or usual care. Frailty was measured using the Rockwood cumulative deficit approach. The primary outcome was all-cause death, and secondary outcomes were cardiovascular death and sudden cardiovascular death. A frailty index (FI) was calculable in 1,109 patients. In total, 618 (55.7%) patients were in frailty class 1 (FI <0.210, i.e., not frail), 361 (32.6%) in frailty class 2 (FI 0.211 to 0.310, i.e., more frail), and 130 (11.7%) in frailty class 3 (FI >0.311, i.e., most frail). Compared with patients in FI class 1, those in FI class 2 and 3 had a higher rate of all outcomes. The effect of ICD implantation on all-cause death did not vary significantly by frailty class (class 1, HR 0.92 [95% CI, 0.68 to 1.24]; class 2 to 3, 0.93 [0.73 to 1.19]; Pinteraction = 0.99). Consistent effects were observed for cardiovascular death (Pinteraction = 0.94), but not for sudden cardiovascular death (Pinteraction = 0.03); the beneficial effect of ICD implantation on this outcome appeared to be greater in patients who were more frail. However, when the FI was analyzed as a continuous variable, frailty no longer significantly modified the effects of ICD implantation on any outcome. In conclusion, in patients with nonischemic HFrEF, frailty did not significantly modify the effects of ICD implantation compared with usual care. However, the need for a primary prevention ICD in frail patients with HFrEF receiving contemporary guideline-directed medical therapy remains uncertain. Clinical Trial Registration Number: NCT00542945.
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