Complications Involving the Subcutaneous Implantable Cardioverter Defibrillator: Lessons Learned from MAUDE.

Emily P. Zeitler,Daniel J. Friedman,Zak Loring,Kristen B. Campbell,Sarah A. Goldstein,Zachary K. Wegermann, Jane Schutz, Nicole Smith,Eric Black-Maier,Sana M. Al-Khatib,Jonathan P. Piccini

Heart Rhythm（2019）

Dartmouth Hitchcock Med Ctr | Duke Univ Hosp

Cited 19|Views59

Abstract

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.

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Key words

Complications,Implantable cardioverter-defibrillator,MAUDE,Mortality,Subcutaneous ICD

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