Retrieval of the Leadless Cardiac Pacemaker: A Multicenter Experience. (December 2016)

• Record Type: Journal Article
• Authors: Reddy, Vivek Y.; Miller, Marc A.; Knops, Reinoud E.; Neuzil, Petr; Defaye, Pascal; Jung, Werner; Doshi, Rahul; Castellani, Mark; Strickberger, Adam; Mead, R. Hardwin; Doppalapudi, Harish; Lakkireddy, Dhanunjaya; Bennett, Matthew; Sperzel, Johannes
• Is Part Of: Circulation. Volume 9:Number 12(2016)
• Publication Date: 2016-12
• Subjects: device removal -- heart ventricles -- humans -- pacemaker, artificial -- prostheses and implants; Arrhythmia -- Periodicals; Heart -- Electric properties -- Periodicals; 616.128
• DOI: 10.1161/CIRCEP.116.004626
• Languages: English
• ISSNs: 1941-3149

Abstract

Abstract : Background—: Leadless cardiac pacemakers have emerged as a safe and effective alternative to conventional transvenous single-chamber ventricular pacemakers. Herein, we report a multicenter experience on the feasibility and safety of acute retrieval (<6 weeks) and chronic retrieval (>6 weeks) of the leadless cardiac pacemaker in humans. Methods and Results—: This study included patients enrolled in 3 multicenter trials, who received a leadless cardiac pacemaker implant and who subsequently underwent a device removal attempt. The overall leadless pacemaker retrieval success rate was 94%: for patients whose leadless cardiac pacemaker had been implanted for <6 weeks (acute retrieval cohort), complete retrieval was achieved in 100% (n=5/5); for those implanted for ≥ 6 weeks (chronic retrieval cohort), retrieval was achieved in 91% (n=10/11) of patients. The mean duration of time from implant to retrieval attempt was 346 days (range, 88–1188 days) in the chronic retrieval cohort, and nearly two thirds (n=7; 63%) had been implanted for >6 months before the retrieval attempt. There were no procedure-related adverse events at 30 days post retrieval procedure. Conclusions—: This multicenter experience demonstrated the feasibility and safety of retrieving a chronically implanted single-chamber (right ventricle) active fixation leadless pacemaker. Clinical Trial Registration—: URL:https://www.clinicaltrials.gov . Unique identifiers: NCT02051972, NCT02030418, and NCT01700244.