Key result
CKD is linked to ~2-fold higher 1-year mortality after first ICD or CRT-D implantation.
Why the study?
Registry data are needed to evaluate real-life aspects of ICD and CRT-D patients and compare mortality, comorbidities, and complications with results from randomized controlled trials.
How do mortality rates, comorbidities, and complication rates of real-world ICD and CRT-D recipients compare to those in randomized controlled trials?
Observational (n=4,384)
Yes
How do mortality rates, comorbidities, and complication rates of real-world ICD and CRT-D recipients compare to those in randomized controlled trials?
Absolute Event Rate: 12.3% vs 10.7%
Real-world ICD and CRT-D recipients have more comorbidities and higher 1-year mortality rates than patients in randomized controlled trials, highlighting the significant impact of conditions like chronic kidney disease on outcomes.
Real-world ICD/CRT-D recipients show higher 1-year mortality than RCT participants, especially with CKD; leaves open whether comorbidity-adjusted selection improves outcomes.
BACKGROUND: Registry data add important information to randomized controlled trials (RCT) on real-life aspects of implantable cardioverter-defibrillator (ICD) patients with and without cardiac resynchronization therapy (CRT-D). This analysis of the prospectively conducted German Device Registry aims at comparing mortality rates, comorbidities, complication rates to results from RCT. METHODS: The German Device registry (DEVICE) prospectively collected data on ICD and CRT-D first implantations from 50 German centres. Demographic data, details on cardiac disease, electrocardiogram (ECG), medication, and data about procedure, complications, and hospital stay were stored in electronic case report forms. One year after device implantation patients were contacted for follow-up. RESULTS: DEVICE included n = 4384 first ICD/CRT-D implantations (29.3% CRT-D devices). We found a strong adherence to guidelines with over 90% of patients being on ß-blocker and ACE-inhibitor medication and adequate QRS width in the majority of CRT-D patients. Patients receiving a CRT-D were older (67.6 ± 11.0 years vs. 63.9 ± 13.4 years, p < .001) and had lower ejection fractions (mean 25% vs. 30%, p < .001) compared to ICD patients. Dilated cardiomyopathy was the predominant underlying heart disease in CRT-D (53.3%), coronary artery disease in ICD patients (64.7%). Compared to RCT our DEVICE patients had more comorbidities (17.9% chronic kidney disease [CKD]) and higher 1-year mortality rates (10.7% ICD group, 12.3% CRT group). In multivariate analysis, CKD patients had an almost 2-fold higher risk of 1-year mortality. CONCLUSION: Despite relevant limitations of registry data, DEVICE highlights important differences between RCT and real-world registry data and the impact of comorbidities on mortality of ICD and CRT-D recipients.
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Köbe et al. (2022) conducted an observational in ICD and CRT-D first implantations (n=4,384). CRT-D vs. ICD was evaluated on 1-year mortality. Real-world patients receiving first ICD or CRT-D implants had 1-year mortality rates of 10.7% and 12.3%, respectively, with chronic kidney disease conferring an almost 2-fold higher mortality risk.
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