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Retrieval of the Leadless Cardiac Pacemaker: A Multicenter Experience. | LitMetric

Retrieval of the Leadless Cardiac Pacemaker: A Multicenter Experience.

Circ Arrhythm Electrophysiol

From the Helmsley Center for Electrophysiology, Icahn School of Medicine at Mount Sinai, New York, NY (V.Y.R., M.A.M.); Department of Cardiology, Amsterdam Medical Center, The Netherlands (R.E.K.); Department of Cardiology, Homolka Hospital, Prague, Czech Republic (V.Y.R., P.N.); Department of Cardiology, CHU, Grenoble, France (P.D.); Department of Cardiology, Schwarzwald Baar Klinikum, Villingen-Schwenningen, Germany (W.J.); Division of Cardiovascular Diseases, USC University Hospital, Los Angeles, CA (R.D.); Department of Cardiology, Sparrow Research, Lansing, MI (M.C.); Department of Cardiology, Inova Fairfax Hospital, VA (A.S.); Department of Cardiology, Sequoia Hospital, Redwood City, CA (R.H.M.); Department of Cardiology, University of Alabama, Birmingham (H.D.); Cardiovascular Research Institute, University of Kansas Medical Center, Kansas City (D.L.); Division of Cardiology, Vancouver General Hospital, British Columbia, Canada (M.B.); and Department of Cardiology, Hospital Kerckhoff Klinik, Bad Nauheim, Germany (J.S.).

Published: December 2016

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.

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Source
http://dx.doi.org/10.1161/CIRCEP.116.004626DOI Listing

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