Tom F Brouwer1, Dilek Yilmaz2, Robert Lindeboom3, Maurits S Buiten2, Louise R A Olde Nordkamp4, Martin J Schalij2, Arthur A Wilde4, Lieselot van Erven2, Reinoud E Knops4. 1. Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Medical Center, University of Amsterdam, Amsterdam, the Netherlands. Electronic address: t.f.brouwer@amc.uva.nl. 2. Department of Cardiology, Leiden University Medical Center, University of Leiden, Leiden, the Netherlands. 3. Department of Clinical Epidemiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands. 4. Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
Abstract
BACKGROUND:Transvenous implantable cardioverter-defibrillators (TV-ICDs) improve survival in patients at risk for sudden cardiac death, but complications remain an important drawback. The subcutaneous ICD (S-ICD) was developed to overcome lead-related complications. Comparison of clinical outcomes of both device types in previous studies was hampered by dissimilar patient characteristics. OBJECTIVES: This retrospective study compares long-term clinical outcomes of S-ICD and TV-ICD therapy in a propensity-matched cohort. METHODS: The authors analyzed 1,160 patients who underwent S-ICD or TV-ICD implantation in 2 high-volume hospitals in the Netherlands. Propensity matching for 16 baseline characteristics, including diagnosis, yielded 140 matched pairs. Clinical outcomes were device-related complications requiring surgical intervention, appropriate and inappropriate ICD therapy, and were reported as 5-year Kaplan-Meier rate estimates. RESULTS: All 16 baseline characteristics were balanced in the matched cohort of 140 patients with S-ICDs and 140 patients with TV-ICDs (median age 41 years [interquartile range: 30 to 52 years] and 40% women). The complication rate was 13.7% in the S-ICD group versus 18.0% in the TV-ICD group (p = 0.80). The infection rate was 4.1% versus 3.6% in the TV-ICD groups (p = 0.36). Lead complications were lower in the S-ICD arm compared with the TV-ICD arm, 0.8% versus 11.5%, respectively (p = 0.03). S-ICD patients had more nonlead-related complications than TV-ICD patients, 9.9% versus 2.2%, respectively (p = 0.047). Appropriate ICD intervention (antitachycardia pacing and shocks) occurred more often in the TV-ICD group (hazard ratio [HR]: 2.42; p = 0.01). The incidence of appropriate (TV-ICD HR: 1.46; p = 0.36) and inappropriate shocks (TV-ICD HR: 0.85; p = 0.64) was similar. CONCLUSIONS: The complication rate in patients implanted with an S-ICD or TV-ICD was similar, but their nature differed. The S-ICD reduced lead-related complications significantly, at the cost of nonlead-related complications. Rates of appropriate and inappropriate shocks were similar between the 2 groups.
RCT Entities:
BACKGROUND: Transvenous implantable cardioverter-defibrillators (TV-ICDs) improve survival in patients at risk for sudden cardiac death, but complications remain an important drawback. The subcutaneous ICD (S-ICD) was developed to overcome lead-related complications. Comparison of clinical outcomes of both device types in previous studies was hampered by dissimilar patient characteristics. OBJECTIVES: This retrospective study compares long-term clinical outcomes of S-ICD and TV-ICD therapy in a propensity-matched cohort. METHODS: The authors analyzed 1,160 patients who underwent S-ICD or TV-ICD implantation in 2 high-volume hospitals in the Netherlands. Propensity matching for 16 baseline characteristics, including diagnosis, yielded 140 matched pairs. Clinical outcomes were device-related complications requiring surgical intervention, appropriate and inappropriate ICD therapy, and were reported as 5-year Kaplan-Meier rate estimates. RESULTS: All 16 baseline characteristics were balanced in the matched cohort of 140 patients with S-ICDs and 140 patients with TV-ICDs (median age 41 years [interquartile range: 30 to 52 years] and 40% women). The complication rate was 13.7% in the S-ICD group versus 18.0% in the TV-ICD group (p = 0.80). The infection rate was 4.1% versus 3.6% in the TV-ICD groups (p = 0.36). Lead complications were lower in the S-ICD arm compared with the TV-ICD arm, 0.8% versus 11.5%, respectively (p = 0.03). S-ICDpatients had more nonlead-related complications than TV-ICD patients, 9.9% versus 2.2%, respectively (p = 0.047). Appropriate ICD intervention (antitachycardia pacing and shocks) occurred more often in the TV-ICD group (hazard ratio [HR]: 2.42; p = 0.01). The incidence of appropriate (TV-ICD HR: 1.46; p = 0.36) and inappropriate shocks (TV-ICD HR: 0.85; p = 0.64) was similar. CONCLUSIONS: The complication rate in patients implanted with an S-ICD or TV-ICD was similar, but their nature differed. The S-ICD reduced lead-related complications significantly, at the cost of nonlead-related complications. Rates of appropriate and inappropriate shocks were similar between the 2 groups.
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