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Retrieval of the Leadless Cardiac Pacemaker: A Multicenter Experience
VY. Reddy, MA. Miller, RE. Knops, P. Neuzil, P. Defaye, W. Jung, R. Doshi, M. Castellani, A. Strickberger, RH. Mead, H. Doppalapudi, D. Lakkireddy, M. Bennett, J. Sperzel,
Circulation. Arrhythmia and electrophysiology.
2016 ;
9 (12) :
.
Jazyk angličtina Země Spojené státy americké
Typ dokumentu klinické zkoušky, časopisecké články, multicentrická studie
Perzistentní odkaz
https://www.medvik.cz/link/bmc17023447
Online
Plný text
NLK
Free Medical Journals
od 2008 do Před 1 rokem
Open Access Digital Library
od 2008-04-01
- MeSH
- bezpečnost pacientů MeSH
- design vybavení MeSH
- kardiostimulátor škodlivé účinky MeSH
- lidé MeSH
- odstranění implantátu * MeSH
- senioři MeSH
- srdeční arytmie terapie MeSH
- studie proveditelnosti MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
- multicentrická studie MeSH
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.
Cardiovascular Research Institute University of Kansas Medical Center Kansas City
Department of Cardiology Amsterdam Medical Center The Netherlands
Department of Cardiology CHU Grenoble France
Department of Cardiology Homolka Hospital Prague Czech Republic
Department of Cardiology Hospital Kerckhoff Klinik Bad Nauheim Germany
Department of Cardiology Inova Fairfax Hospital VA
Department of Cardiology Schwarzwald Baar Klinikum Villingen Schwenningen Germany
Department of Cardiology Sequoia Hospital Redwood City CA
Department of Cardiology Sparrow Research Lansing MI
Department of Cardiology University of Alabama Birmingham
Division of Cardiology Vancouver General Hospital British Columbia Canada
Division of Cardiovascular Diseases USC University Hospital Los Angeles CA
From the Helmsley Center for Electrophysiology Icahn School of Medicine at Mount Sinai New York NY
Citace poskytuje Crossref.org
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- $a Reddy, Vivek Y $u 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.
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- $a Retrieval of the Leadless Cardiac Pacemaker: A Multicenter Experience / $c VY. Reddy, MA. Miller, RE. Knops, P. Neuzil, P. Defaye, W. Jung, R. Doshi, M. Castellani, A. Strickberger, RH. Mead, H. Doppalapudi, D. Lakkireddy, M. Bennett, J. Sperzel,
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- $a 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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- $a Miller, Marc A $u 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.).
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- $a Knops, Reinoud E $u 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.).
- 700 1_
- $a Neuzil, Petr $u 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.).
- 700 1_
- $a Defaye, Pascal $u 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.).
- 700 1_
- $a Jung, Werner $u 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.).
- 700 1_
- $a Doshi, Rahul $u 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.).
- 700 1_
- $a Castellani, Mark $u 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.).
- 700 1_
- $a Strickberger, Adam $u 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.).
- 700 1_
- $a Mead, R Hardwin $u 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.).
- 700 1_
- $a Doppalapudi, Harish $u 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.).
- 700 1_
- $a Lakkireddy, Dhanunjaya $u 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.).
- 700 1_
- $a Bennett, Matthew $u 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.).
- 700 1_
- $a Sperzel, Johannes $u 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.).
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