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

Area of Science:

• Cardiology
• Medical Devices
• Electrophysiology

Background:

• Implantable cardioverter defibrillator (ICD) therapy has been standard for sudden cardiac death prevention for over 20 years.
• ICD implantation is used for both primary and secondary prevention of life-threatening ventricular arrhythmias.

Purpose of the Study:

• To evaluate the benefit-harm profile of contemporary primary prophylactic ICD therapy.
• To analyze trends in ICD therapy and complication rates over two decades.

Main Methods:

• Analysis of 1222 patients from a prospective single-center ICD registry undergoing primary prophylactic ICD implantation (2000-2017).
• Patients were divided into two groups: 2010-2017 (n=579) and 2000-2009 (n=643).
• Comparison of appropriate ICD therapy rates, complication rates, and specific adverse events between the two groups.

Main Results:

• Appropriate ICD therapy rates decreased from 51% in the 2000s to 42% in the 2010s (P<.001).
• Overall complication rates slightly decreased from 53% to 47% (P=.005), primarily due to reduced inappropriate shocks (30% vs 14%, P<.001).
• Rates of lead malfunction and device infection remained unchanged; nonischemic cardiomyopathy predicted complications without therapy benefit (HR 1.37).

Conclusions:

• Primary prophylactic ICD therapy rates for ventricular arrhythmias have declined over the past two decades.
• High complication rates persist, driven by unchanged rates of lead malfunctions and device infections.
• Nonischemic cardiomyopathy is an independent predictor of ICD complications without therapeutic benefit in primary prophylactic ICD therapy.