Low inappropriate shock rates in patients with single- and dual/triple-chamber implantable cardioverter-defibrillators using a novel suite of detection algorithms: PainFree SST trial primary results

Heart Rhythm. 2015 May;12(5):926-36. doi: 10.1016/j.hrthm.2015.01.017. Epub 2015 Jan 28.

Abstract

Background: The 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.

Objective: The 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.

Methods: This 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).

Results: The 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.

Conclusion: In 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.

Keywords: Atrial fibrillation; Cardiac resynchronization therapy; Heart failure; Implantable cardioverter-defibrillator; Inappropriate shock.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Algorithms*
  • Death, Sudden, Cardiac* / etiology
  • Death, Sudden, Cardiac* / prevention & control
  • Defibrillators, Implantable / adverse effects*
  • Electric Countershock* / adverse effects
  • Electric Countershock* / instrumentation
  • Electric Countershock* / methods
  • Equipment Design
  • Female
  • Humans
  • Male
  • Middle Aged
  • Pain* / etiology
  • Pain* / prevention & control
  • Primary Prevention
  • Tachycardia, Ventricular* / complications
  • Tachycardia, Ventricular* / therapy
  • Treatment Outcome