• Angelo Auricchio, Edward J Schloss, Takashi Kurita, Albert Meijer, Bart Gerritse, Steven Zweibel, Faisal M AlSmadi, Charles T Leng, Laurence D Sterns, and PainFree SST Investigators.
• Fondazione Cardiocentro Ticino, Lugano, Switzerland. Electronic address: angelo.auricchio@cardiocentro.org.
• Heart Rhythm. 2015 May 1; 12 (5): 926-36.

BackgroundThe benefits of implantable cardioverter-defibrillators (ICDs) have been well demonstrated in many clinical trials, and ICD shocks for ventricular tachyarrhythmias save lives. However, inappropriate and unnecessary shock delivery remains a significant clinical issue with considerable consequences for patients and the healthcare system.ObjectiveThe purpose of the PainFree SmartShock Technology (SST) study was to investigate new-generation ICDs to reduce inappropriate and unnecessary shocks through novel discrimination algorithms with modern programming strategies.MethodsThis prospective, multicenter clinical trial enrolled 2790 patients with approved indication for ICD implantation (79% male, mean age 65 years; 69% primary prevention indication, 27% single-chamber ICD, 33% replacement or upgrade). Patients were followed for a minimum of 12 months, and mean follow-up was 22 months. The primary end-point of the study was the percentage of patients remaining free of inappropriate shocks at 1 year postimplant, analyzed separately for dual/triple-chamber ICDs (N = 2019) and single-chamber ICDs (N = 751).ResultsThe inappropriate shock rate at 1 year was 1.5% for patients with dual/triple-chamber ICDs and 2.5% for patients with single-chamber devices. Two years postimplant, the inappropriate shock rate was 2.8% for patients with dual-/triple chamber ICDs and 3.7% for those with single-chamber ICDs. The most common cause of an inappropriate shock in both groups was atrial fibrillation or flutter.ConclusionIn a large patient cohort receiving ICDs for primary or secondary prevention, the adoption of novel enhanced detection algorithms in conjunction with routine implementation of modern programming strategies led to a very low inappropriate shock rate.Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

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