Complication Rates Associated With Pacemaker or Implantable Cardioverter-Defibrillator Generator Replacements and Upgrade Procedures
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- Jeanne E. Poole
- From the University of Washington, Seattle (J.E.P.); Washington University in St Louis, School of Medicine, St Louis, Mo (M.J.G.); Massachusetts General Hospital, Boston (T.M.); Cleveland Clinic, Cleveland, Ohio (M.K.C.); University of California Los Angeles (D.Z.U.); Abington Medical Specialists, Abington, Pa (R.B.); South Carolina Heart Center, Columbia (V.K.); Michigan Heart, Ypsilanti (T.S., S.A.W.); Piedmont Heart Institute, Atlanta, Ga (D.D.); Desert Cardiology, Rancho Mirage, Calif (L.A.F.);...
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- Marye J. Gleva
- From the University of Washington, Seattle (J.E.P.); Washington University in St Louis, School of Medicine, St Louis, Mo (M.J.G.); Massachusetts General Hospital, Boston (T.M.); Cleveland Clinic, Cleveland, Ohio (M.K.C.); University of California Los Angeles (D.Z.U.); Abington Medical Specialists, Abington, Pa (R.B.); South Carolina Heart Center, Columbia (V.K.); Michigan Heart, Ypsilanti (T.S., S.A.W.); Piedmont Heart Institute, Atlanta, Ga (D.D.); Desert Cardiology, Rancho Mirage, Calif (L.A.F.);...
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- Theofanie Mela
- From the University of Washington, Seattle (J.E.P.); Washington University in St Louis, School of Medicine, St Louis, Mo (M.J.G.); Massachusetts General Hospital, Boston (T.M.); Cleveland Clinic, Cleveland, Ohio (M.K.C.); University of California Los Angeles (D.Z.U.); Abington Medical Specialists, Abington, Pa (R.B.); South Carolina Heart Center, Columbia (V.K.); Michigan Heart, Ypsilanti (T.S., S.A.W.); Piedmont Heart Institute, Atlanta, Ga (D.D.); Desert Cardiology, Rancho Mirage, Calif (L.A.F.);...
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- Mina K. Chung
- From the University of Washington, Seattle (J.E.P.); Washington University in St Louis, School of Medicine, St Louis, Mo (M.J.G.); Massachusetts General Hospital, Boston (T.M.); Cleveland Clinic, Cleveland, Ohio (M.K.C.); University of California Los Angeles (D.Z.U.); Abington Medical Specialists, Abington, Pa (R.B.); South Carolina Heart Center, Columbia (V.K.); Michigan Heart, Ypsilanti (T.S., S.A.W.); Piedmont Heart Institute, Atlanta, Ga (D.D.); Desert Cardiology, Rancho Mirage, Calif (L.A.F.);...
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- Daniel Z. Uslan
- From the University of Washington, Seattle (J.E.P.); Washington University in St Louis, School of Medicine, St Louis, Mo (M.J.G.); Massachusetts General Hospital, Boston (T.M.); Cleveland Clinic, Cleveland, Ohio (M.K.C.); University of California Los Angeles (D.Z.U.); Abington Medical Specialists, Abington, Pa (R.B.); South Carolina Heart Center, Columbia (V.K.); Michigan Heart, Ypsilanti (T.S., S.A.W.); Piedmont Heart Institute, Atlanta, Ga (D.D.); Desert Cardiology, Rancho Mirage, Calif (L.A.F.);...
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- Richard Borge
- From the University of Washington, Seattle (J.E.P.); Washington University in St Louis, School of Medicine, St Louis, Mo (M.J.G.); Massachusetts General Hospital, Boston (T.M.); Cleveland Clinic, Cleveland, Ohio (M.K.C.); University of California Los Angeles (D.Z.U.); Abington Medical Specialists, Abington, Pa (R.B.); South Carolina Heart Center, Columbia (V.K.); Michigan Heart, Ypsilanti (T.S., S.A.W.); Piedmont Heart Institute, Atlanta, Ga (D.D.); Desert Cardiology, Rancho Mirage, Calif (L.A.F.);...
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- Venkateshwar Gottipaty
- From the University of Washington, Seattle (J.E.P.); Washington University in St Louis, School of Medicine, St Louis, Mo (M.J.G.); Massachusetts General Hospital, Boston (T.M.); Cleveland Clinic, Cleveland, Ohio (M.K.C.); University of California Los Angeles (D.Z.U.); Abington Medical Specialists, Abington, Pa (R.B.); South Carolina Heart Center, Columbia (V.K.); Michigan Heart, Ypsilanti (T.S., S.A.W.); Piedmont Heart Institute, Atlanta, Ga (D.D.); Desert Cardiology, Rancho Mirage, Calif (L.A.F.);...
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- Timothy Shinn
- From the University of Washington, Seattle (J.E.P.); Washington University in St Louis, School of Medicine, St Louis, Mo (M.J.G.); Massachusetts General Hospital, Boston (T.M.); Cleveland Clinic, Cleveland, Ohio (M.K.C.); University of California Los Angeles (D.Z.U.); Abington Medical Specialists, Abington, Pa (R.B.); South Carolina Heart Center, Columbia (V.K.); Michigan Heart, Ypsilanti (T.S., S.A.W.); Piedmont Heart Institute, Atlanta, Ga (D.D.); Desert Cardiology, Rancho Mirage, Calif (L.A.F.);...
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- Dan Dan
- From the University of Washington, Seattle (J.E.P.); Washington University in St Louis, School of Medicine, St Louis, Mo (M.J.G.); Massachusetts General Hospital, Boston (T.M.); Cleveland Clinic, Cleveland, Ohio (M.K.C.); University of California Los Angeles (D.Z.U.); Abington Medical Specialists, Abington, Pa (R.B.); South Carolina Heart Center, Columbia (V.K.); Michigan Heart, Ypsilanti (T.S., S.A.W.); Piedmont Heart Institute, Atlanta, Ga (D.D.); Desert Cardiology, Rancho Mirage, Calif (L.A.F.);...
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- Leon A. Feldman
- From the University of Washington, Seattle (J.E.P.); Washington University in St Louis, School of Medicine, St Louis, Mo (M.J.G.); Massachusetts General Hospital, Boston (T.M.); Cleveland Clinic, Cleveland, Ohio (M.K.C.); University of California Los Angeles (D.Z.U.); Abington Medical Specialists, Abington, Pa (R.B.); South Carolina Heart Center, Columbia (V.K.); Michigan Heart, Ypsilanti (T.S., S.A.W.); Piedmont Heart Institute, Atlanta, Ga (D.D.); Desert Cardiology, Rancho Mirage, Calif (L.A.F.);...
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- Hanscy Seide
- From the University of Washington, Seattle (J.E.P.); Washington University in St Louis, School of Medicine, St Louis, Mo (M.J.G.); Massachusetts General Hospital, Boston (T.M.); Cleveland Clinic, Cleveland, Ohio (M.K.C.); University of California Los Angeles (D.Z.U.); Abington Medical Specialists, Abington, Pa (R.B.); South Carolina Heart Center, Columbia (V.K.); Michigan Heart, Ypsilanti (T.S., S.A.W.); Piedmont Heart Institute, Atlanta, Ga (D.D.); Desert Cardiology, Rancho Mirage, Calif (L.A.F.);...
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- Stuart A. Winston
- From the University of Washington, Seattle (J.E.P.); Washington University in St Louis, School of Medicine, St Louis, Mo (M.J.G.); Massachusetts General Hospital, Boston (T.M.); Cleveland Clinic, Cleveland, Ohio (M.K.C.); University of California Los Angeles (D.Z.U.); Abington Medical Specialists, Abington, Pa (R.B.); South Carolina Heart Center, Columbia (V.K.); Michigan Heart, Ypsilanti (T.S., S.A.W.); Piedmont Heart Institute, Atlanta, Ga (D.D.); Desert Cardiology, Rancho Mirage, Calif (L.A.F.);...
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- John J. Gallagher
- From the University of Washington, Seattle (J.E.P.); Washington University in St Louis, School of Medicine, St Louis, Mo (M.J.G.); Massachusetts General Hospital, Boston (T.M.); Cleveland Clinic, Cleveland, Ohio (M.K.C.); University of California Los Angeles (D.Z.U.); Abington Medical Specialists, Abington, Pa (R.B.); South Carolina Heart Center, Columbia (V.K.); Michigan Heart, Ypsilanti (T.S., S.A.W.); Piedmont Heart Institute, Atlanta, Ga (D.D.); Desert Cardiology, Rancho Mirage, Calif (L.A.F.);...
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- Jonathan J. Langberg
- From the University of Washington, Seattle (J.E.P.); Washington University in St Louis, School of Medicine, St Louis, Mo (M.J.G.); Massachusetts General Hospital, Boston (T.M.); Cleveland Clinic, Cleveland, Ohio (M.K.C.); University of California Los Angeles (D.Z.U.); Abington Medical Specialists, Abington, Pa (R.B.); South Carolina Heart Center, Columbia (V.K.); Michigan Heart, Ypsilanti (T.S., S.A.W.); Piedmont Heart Institute, Atlanta, Ga (D.D.); Desert Cardiology, Rancho Mirage, Calif (L.A.F.);...
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- Kevin Mitchell
- From the University of Washington, Seattle (J.E.P.); Washington University in St Louis, School of Medicine, St Louis, Mo (M.J.G.); Massachusetts General Hospital, Boston (T.M.); Cleveland Clinic, Cleveland, Ohio (M.K.C.); University of California Los Angeles (D.Z.U.); Abington Medical Specialists, Abington, Pa (R.B.); South Carolina Heart Center, Columbia (V.K.); Michigan Heart, Ypsilanti (T.S., S.A.W.); Piedmont Heart Institute, Atlanta, Ga (D.D.); Desert Cardiology, Rancho Mirage, Calif (L.A.F.);...
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- Richard Holcomb
- From the University of Washington, Seattle (J.E.P.); Washington University in St Louis, School of Medicine, St Louis, Mo (M.J.G.); Massachusetts General Hospital, Boston (T.M.); Cleveland Clinic, Cleveland, Ohio (M.K.C.); University of California Los Angeles (D.Z.U.); Abington Medical Specialists, Abington, Pa (R.B.); South Carolina Heart Center, Columbia (V.K.); Michigan Heart, Ypsilanti (T.S., S.A.W.); Piedmont Heart Institute, Atlanta, Ga (D.D.); Desert Cardiology, Rancho Mirage, Calif (L.A.F.);...
書誌事項
- タイトル別名
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- Results From the REPLACE Registry
- 公開日
- 2010-10-19
- DOI
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- 10.1161/circulationaha.110.976076
- 公開者
- Ovid Technologies (Wolters Kluwer Health)
この論文をさがす
説明
<jats:sec> <jats:title>Background—</jats:title> <jats:p>Prospective studies defining the risk associated with pacemaker or implantable cardioverter-defibrillator replacement surgeries do not exist. These procedures are generally considered low risk despite results from recent retrospective series reporting higher rates.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods and Results—</jats:title> <jats:p>We prospectively assessed predefined procedure-related complication rates associated with elective pacemaker or implantable cardioverter-defibrillator generator replacements over 6 months of follow-up. Two groups were studied: those without (cohort 1) and those with (cohort 2) a planned transvenous lead addition for replacement or upgrade to a device capable of additional therapies. Complications were adjudicated by an independent events committee. Seventy-two US academic and private practice centers participated. Major complications occurred in 4.0% (95% confidence interval, 2.9 to 5.4) of 1031 cohort 1 patients and 15.3% (95% confidence interval, 12.7 to 18.1) of 713 cohort 2 patients. In both cohorts, major complications were higher with implantable cardioverter-defibrillator compared with pacemaker generator replacements. Complications were highest in patients who had an upgrade to or a revised cardiac resynchronization therapy device (18.7%; 95% confidence interval, 15.1 to 22.6). No periprocedural deaths occurred in either cohort, although 8 later procedure-related deaths occurred in cohort 2. The 6-month infection rates were 1.4% (95% confidence interval, 0.7 to 2.3) and 1.1% (95% confidence interval, 0.5 to 2.2) for cohorts 1 and 2, respectively.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions—</jats:title> <jats:p>Pacemaker and implantable cardioverter-defibrillator generator replacements are associated with a notable complication risk, particularly those with lead additions. These data support careful decision making before device replacement, when managing device advisories, and when considering upgrades to more complex systems.</jats:p> </jats:sec> <jats:sec> <jats:title>Clinical Trial Registration—</jats:title> <jats:p> URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov">http://www.clinicaltrials.gov</jats:ext-link> . Unique identifier: NCT00395447. </jats:p> </jats:sec>
収録刊行物
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- Circulation
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Circulation 122 (16), 1553-1561, 2010-10-19
Ovid Technologies (Wolters Kluwer Health)