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

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  1 , Kevin Willy  1 , Jochen Senges  2 , Matthias Hochadel  2 , Thomas Kleemann  3 , Stefan G Spitzer  4 , Dietrich Andresen  5 , Joachim Jehle  6 , Gerhard Steinbeck  7 , Istvan Szendey  8 , Christian Butter  9 , Johannes Brachmann  10 , Ellen Hoffmann  11 , Lars Eckardt  1
Affiliations

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 et al. J Cardiovasc Electrophysiol. 2022 Mar.

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.

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References

REFERENCES

    1. Al-Khatib SM, Stevenson WG, Ackerman MJ, et al. AHA/ACC/HRS guideline for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: executive summary: a report of the American College of Cardiology/American Heart Association task force on clinical practice guidelines and the heart rhythm society. Heart Rhythm. 2018;15(10):e190-e252.
    1. Priori SG, Blomstrom-Lundqvist C, Mazzanti A, et al. ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: the task force for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death of the European Society of Cardiology (ESC) Endorsed by: association for European Paediatric and Congenital Cardiology (AEPC). Eur Heart J. 2015;36(41):2793-2867.
    1. Wuest S, Twerenbold R, Kuhne M, et al. Reassessment of cardiovascular parameters and comorbidities in implantable cardioverter-defibrillator patients at the time of first replacement. Clin Cardiol. 2018;41(1):57-62.
    1. Bardy GH, Lee KL, Mark DB, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005;352(3):225-237.
    1. Moss AJ, Greenberg H, Case RB, et al. Long-term clinical course of patients after termination of ventricular tachyarrhythmia by an implanted defibrillator. Circulation. 2004;110(25):3760-3765.

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