Vivek Y Reddy1, Marc A Miller2, Reinoud E Knops2, Petr Neuzil2, Pascal Defaye2, Werner Jung2, Rahul Doshi2, Mark Castellani2, Adam Strickberger2, R Hardwin Mead2, Harish Doppalapudi2, Dhanunjaya Lakkireddy2, Matthew Bennett2, Johannes Sperzel2. 1. 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.) vivek.reddy@mountsinai.org. 2. 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.).
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.
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.
Authors: Roshini S Asirvatham; Vaibhav R Vaidya; Trena M Thome; Paul A Friedman; Yong-Mei Cha Journal: J Interv Card Electrophysiol Date: 2019-11-14 Impact factor: 1.900