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.