Subclinical atrial fibrillation detection with a floating atrial sensing dipole in single lead implantable cardioverter-defibrillator systems: Results of the SENSE trial

J Cardiovasc Electrophysiol. 2019 Oct;30(10):1994-2001. doi: 10.1111/jce.14081. Epub 2019 Aug 5.

Abstract

Introduction: Subclinical atrial fibrillation (AF), in the form of cardiac implantable device-detected atrial high rate episodes (AHREs), has been associated with increased thromboembolism. An implantable cardioverter-defibrillator (ICD) lead with a floating atrial dipole may permit a single lead (DX) ICD system to detect AHREs. We sought to assess the utility of the DX ICD system for subclinical AF detection in patients, with a prospective multicenter, cohort-controlled trial.

Methods and results: One hundred fifty patients without prior history of AF (age 59 ± 13 years; 108 [72%] male) were enrolled into the DX cohort and implanted with a Biotronik DX ICD system at eight centers. Age-, sex-, and left ventricular ejection fraction-matched single- and dual-chamber ICD cohorts were derived from a Cornell database and from the IMPACT trial, respectively. The primary endpoint were AHRE detection at 12 months. During median 12 months follow-up, AHREs were detected in 19 (13%) patients in the DX, 8 (5.3%) in the single-chamber, and 19 (13%) in the dual-chamber cohorts. The rate of AHRE detection was significantly higher in the DX cohort compared to the single-chamber cohort (P = .026), but not significantly different compared to the dual-chamber cohort. There were no inappropriate ICD therapies in the DX cohort. At 12 months, only 3.0% of patients in the DX cohort had sensed atrial amplitudes less than 1.0 mV.

Conclusion: Use of a DX ICD lead allows subclinical AF detection with a single lead DX system that is superior to that of a conventional single-chamber ICD system.

Keywords: implantable cardioverter-defibrillator; remote monitoring; subclinical atrial fibrillation.

Publication types

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

MeSH terms

  • Action Potentials
  • Adult
  • Aged
  • Asymptomatic Diseases
  • Atrial Fibrillation / diagnosis*
  • Atrial Fibrillation / physiopathology
  • Death, Sudden, Cardiac / prevention & control*
  • Defibrillators, Implantable*
  • Electric Countershock / instrumentation*
  • Electrophysiologic Techniques, Cardiac / instrumentation*
  • Female
  • Heart Rate
  • Humans
  • Male
  • Middle Aged
  • Predictive Value of Tests
  • Prospective Studies
  • Remote Sensing Technology / instrumentation*
  • Time Factors
  • United States