Complications involving the subcutaneous implantable cardioverter-defibrillator: Lessons learned from MAUDE.

BACKGROUND: Reports on the subcutaneous implantable cardioverter-defibrillator (S-ICD) cumulatively demonstrate a low rate of complications, but clinical experience with this technology is limited compared with transvenous devices. OBJECTIVE: The purpose of this study was to describe and analyze S-ICD complications reported to the Food and Drug Administration's Manufacturer and User Facility Device Experience database. METHODS: We reviewed all S-ICD events reported to the Manufacturer and User Facility Device Experience submitted over 24 months (from February 2016 through February 2018) through a prospective and standardized approach at a time when an estimated 15,000 S-ICDs were in service. RESULTS: After removing duplicate entries and nonclinical events (n = 493), 1604 events remained. A total of 542 instances of infection were reported with system removal in 414/542 (77.5%). Inappropriate shocks occurred in 550 patients, and 382 (69%) were attributed to oversensing; in response, 254 (56%), 147 (33%), and 80 (18%) patients underwent system reprogramming, removal, or revision, respectively. There were 15 deaths, and causes included defibrillation failure during follow-up (n = 2), ventricular fibrillation induced by the device (n = 4), device-device interaction resulting in undersensing (n = 1), procedure-related complications (n = 4), and uncertain etiology (n = 4). There were 137 reports of system migration, and in 57 (42%) of these, there were associated inappropriate shocks. System migration events were managed with a combination of system revision (69 [51%]), reprogramming (25 [18%]), and system removal (44 [32%]). CONCLUSION: Several S-ICD complications have been reported that appear to be related to the ICD's design and function over time. A better understanding of these complications may help inform patient selection, implant technique, and postimplantation management.

Duke Scholars

Author Daniel Friedman Medicine, Cardiology

Author Zak Loring Medicine, Cardiology

Author Sana Mustapha Al-Khatib Medicine, Cardiology

Author Jonathan Paul Piccini Sr. Medicine, Cardiology