Safety and Efficacy of the Totally Subcutaneous Implantable Defibrillator 2-Year Results From a Pooled Analysis of the IDE Study and EFFORTLESS Registry

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:65

Article

Burke, Martin C.¹  Gold, Michael R.²  Knight, Bradley P.³  Barr, Craig S.⁴  Theuns, Dominic A. M. J.⁵  Boersma, Lucas V. A.⁶  Knops, Reinoud E.⁷  Weiss, Raul⁸  Leon, Angel R.⁹  Herre, John M.¹⁰  Husby, Michael¹¹  Stein, Kenneth M.¹¹  Lambiase, Pier D.¹² 

[1] Univ Chicago, Heart Rhythm Ctr, Chicago, IL 60637 USA

[2] Med Univ S Carolina, Charleston, SC 29425 USA

[3] Northwestern Univ, Chicago, IL 60611 USA

[4] Russells Hall Hosp, Dudley, England

[5] Erasmus MC, Rotterdam, Netherlands

[6] St Antonius Hosp, Nieuwegein, Netherlands

[7] Univ Amsterdam, Acad Med Ctr, NL-1105 AZ Amsterdam, Netherlands

[8] Ohio State Univ, Columbus, OH 43210 USA

[9] Emory Univ, Atlanta, GA 30322 USA

[10] Sentara Cardiol Specialists, Norfolk, VA USA

[11] Boston Sci, St Paul, MN USA

[12] Heart Hosp, London, England

关键词: pacing;    rhythm disorders;    tachyarrhythmias;    ventricular fibrillation;   

DOI  :  10.1016/j.jacc.2015.02.047

来源: Elsevier

【 摘 要 】

BACKGROUND The entirely subcutaneous implantable cardioverter-defibrillator (S-ICD) is the first implantable defibrillator that avoids placing electrodes in or around the heart. Two large prospective studies (IDE [S-ICD System IDE Clinical Investigation] and EFFORTLESS [Boston Scientific Post Market S-ICD Registry]) have reported 6-month to 1-year data on the S-ICD. OBJECTIVES The objective of this study was to evaluate the safety and efficacy of the S-ICD in a large diverse population. METHODS Data from the IDE and EFFORTLESS studies were pooled. Shocks were independently adjudicated, and complications were measured with a standardized classification scheme. Enrollment date quartiles were used to assess event rates over time. RESULTS Eight hundred eighty-two patients who underwent implantation were followed for 651 +/- 345 days. Spontaneous ventricular tachyarrhythmia (VT)/ventricular fibrillation (VF) events (n = 111) were treated in 59 patients; 100 (90.1%) events were terminated with 1 shock, and 109 events (98.2%) were terminated within the 5 available shocks. The estimated 3-year inappropriate shock rate was 13.1%. Estimated 3-year, all-cause mortality was 4.7% (95% confidence interval: 0.9% to 8.5%), with 26 deaths (2.9%). Device-related complications occurred in 11.1% of patients at 3 years. There were no electrode failures, and no S-ICD-related endocarditis or bacteremia occurred. Three devices (0.3%) were replaced for right ventricular pacing. The 6-month complication rate decreased by quartile of enrollment (Q1: 8.9%; Q4: 5.5%), and there was a trend toward a reduction in inappropriate shocks (Q1: 6.9% Q4: 4.5%). CONCLUSIONS The S-ICD demonstrated high efficacy for VT/VF. Complications and inappropriate shock rates were reduced consistently with strategic programming and as operator experience increased. These data provide further evidence for the safety and efficacy of the S-ICD. (C) 2015 by the American College of Cardiology Foundation.

【 授权许可】

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