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. 2019 Oct;42(10):866-872.
doi: 10.1002/clc.23234. Epub 2019 Jul 17.

Contemporary benefit-harm profile over two decades in primary prophylactic ICD-therapy

Thomas Kleemann  1 , Margit Strauss  1 , Kleopatra Kouraki  1 , Eleni Lampropoulou  1 , Andràs Fendt  1 , Nicolas Werner  1 , Ralf Zahn  1
Affiliations

Contemporary benefit-harm profile over two decades in primary prophylactic ICD-therapy

Thomas Kleemann et al. Clin Cardiol. 2019 Oct.

Abstract

Background: Implantable cardioverter defibrillator (ICD) was implemented into clinical routine more than 20 years ago. Since then, ICD therapy became standard therapy for primary and secondary prevention of sudden cardiac death in clinical practice.

Objectives: Aim of the study was to evaluate the benefit-harm profile of contemporary primary prophylactic ICD therapy.

Methods: A total of 1222 consecutive patients of a prospective single-center ICD-registry were analyzed who underwent primary prophylactic ICD implantation between 2000 and 2017. Patients were divided into two groups according to the implantation year: 2010-2017 (group 1, n = 579) and 2000-2009 (group 2, n = 643).

Results: The rate of estimated appropriate ICD therapy after 8 years was 51% in the 2000s and 42% in the 2010s (P < .001). The complication rate changed slightly from 53% to 47% (P = .005). This decline was mainly driven by the reduction of inappropriate ICD shocks (30% vs 14%, P < .001) whereas the rate of ICD shock lead malfunction and device/ lead infection remained unchanged over time. Nonischemic cardiomyopathy was an independent predictor for ICD complications without benefit of ICD therapy (HR 1.37, 95% CI 1.07-1.77).

Conclusion: The ICD therapy rate for ventricular arrhythmias in patients with primary prophylactic ICD implantation is decreasing over the last two decades. Complication rate remains high due to an unchanged rate of ICD shock malfunctions and device infections. Nonischemic cardiomyopathy is an independent predictor for ICD complications without benefit of ICD therapy in primary prophylactic ICD-therapy.

Keywords: ICD complications; ICD shock; defibrillation; implantable cardioverter defibrillator (ICD); primary prophylactic ICD.

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Conflict of interest statement

The authors declare no potential conflict of interests.

Figures

Figure 1
Figure 1
Kaplan‐Meier curves showing the incidence of appropriate ICD therapy. Patients were stratified according to the implantation decade. ICD, implantable cardioverter defibrillator
Figure 2
Figure 2
Kaplan‐Meier curves showing the incidence of ICD‐related complications. Patients were stratified according to the implantation decade. ICD, implantable cardioverter defibrillator
Figure 3
Figure 3
Kaplan‐Meier curves displaying the incidence of inappropriate ICD shocks. Patients were stratified according to the implantation decade. ICD, implantable cardioverter defibrillator
Figure 4
Figure 4
Kaplan‐Meier curves showing the incidence of ICD lead failure or malfunction. Patients were stratified according to the implantation decade. ICD, implantable cardioverter defibrillator
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