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

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.