Selection and outcome of implantable cardioverter-defibrillator patients with and without cardiac resynchronization therapy: Comparison of 4384 patients from the German Device Registry to randomized controlled trials

Julia Köbe; Kevin Willy; Jochen Senges; Matthias Hochadel; Thomas Kleemann; Stefan G Spitzer; Dietrich Andresen; Joachim Jehle; Gerhard Steinbeck; Istvan Szendey; Christian Butter; Johannes Brachmann; Ellen Hoffmann; Lars Eckardt

doi:10.1111/jce.15365

Selection and outcome of implantable cardioverter-defibrillator patients with and without cardiac resynchronization therapy: Comparison of 4384 patients from the German Device Registry to randomized controlled trials

J Cardiovasc Electrophysiol. 2022 Mar;33(3):483-492. doi: 10.1111/jce.15365. Epub 2022 Jan 23.

Authors

Affiliations

¹ Division of Electrophysiology, Department of Cardiology and Angiology, Münster, Germany.
² Stiftung Institut für Herzinfarktforschung (IHF), Ludwigshafen, Germany.
³ Herzzentrum Ludwigshafen, Ludwigshafen, Germany.
⁴ Praxisklinik Herz und Gefäße, Dresden, Germany.
⁵ Martin Luther Krankenhaus Berlin Charlottenburg, Berlin, Germany.
⁶ Klinikum St. Elisabeth, Straubing, Germany.
⁷ Medical Hospital I, Ludwig-Maximilians-University of Munich, Großhadern, Germany.
⁸ Krankenhaus St. Franziskus Mönchengladbach, Mönchengladbach, Germany.
⁹ Immanuel Herzzentrum Brandenburg, Bernau bei Berlin, Germany.
¹⁰ Klinikum Coburg, Coburg, Germany.
¹¹ Klinik München Bogenhausen, München, Germany.

PMID: 35028995
DOI: 10.1111/jce.15365

Abstract

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.

Keywords: Implantable cardioverter-defibrillator; cardiac resynchronization therapy; national registry; outcome; randomized controlled trials.

MeSH terms

Cardiac Resynchronization Therapy Devices
Cardiac Resynchronization Therapy* / adverse effects
Cardiac Resynchronization Therapy* / methods
Defibrillators, Implantable* / adverse effects
Heart Failure* / diagnosis
Heart Failure* / etiology
Heart Failure* / therapy
Humans
Randomized Controlled Trials as Topic
Registries
Treatment Outcome