Author + information
- Received January 3, 2019
- Revision received February 15, 2019
- Accepted February 18, 2019
- Published online May 13, 2019.
- Joseph J. DeRose Jr., MDa,
- Donna M. Mancini, MDb,∗ (, )@IcahnMountSinai,
- Helena L. Chang, MSb,
- Michael Argenziano, MDc,
- François Dagenais, MDd,
- Gorav Ailawadi, MDe,
- Louis P. Perrault, MD, PhDf,
- Michael K. Parides, PhDa,
- Wendy C. Taddei-Peters, PhDg,
- Michael J. Mack, MDh,
- Donald D. Glower, MDi,
- Babatunde A. Yerokun, MDi,
- Pavan Atluri, MDj,
- John C. Mullen, MDk,
- John D. Puskas, MDl,
- Karen O’Sullivan, MPHb,
- Nancy M. Sledz, PA-Cb,
- Hugo Tremblay, RNd,
- Ellen Moquete, RN, BSNb,
- Bart S. Ferket, MD, PhDb,
- Alan J. Moskowitz, MDb,
- Alexander Iribarne, MD, MSm,
- Annetine C. Gelijns, PhDb,
- Patrick T. O’Gara, MDn,
- Eugene H. Blackstone, MDo,
- A. Marc Gillinov, MDo,
- for the CTSN Investigators
- aDepartment of Cardiothoracic Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, New York, New York
- bInternational Center for Health Outcomes and Innovation Research (InCHOIR), the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York
- cDivision of Cardiothoracic Surgery, Department of Surgery, College of Physicians and Surgeons, Columbia University, New York, New York
- dDepartment of Surgery, Institut de Cardiologie et Pneumologie de Québec, Québec, Canada
- eSection of Adult Cardiac Surgery, University of Virginia, Charlottesville, Virginia
- fDepartment of Surgery, Montreal Heart Institute, Québec, Québec, Canada
- gDivision of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland
- hCardiovascular Surgery, Baylor Scott and White Health, Plano, Texas
- iDepartment of Surgery, Duke University Medical Center, Durham, North Carolina
- jDepartment of Surgery, University of Pennsylvania, Philadelphia, Pennsylvania
- kDivision of Cardiac Surgery, University of Alberta, Edmonton, Alberta, Canada
- lDepartment of Cardiovascular Surgery, Mount Sinai Heart at Saint Luke’s, New York, New York
- mSection of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
- nCardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts
- oDepartment of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio
- ↵∗Address for correspondence:
Dr. Donna M. Mancini, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1077, New York, New York 10029.
Background The incidence of permanent pacemaker (PPM) implantation is higher following mitral valve surgery (MVS) with ablation for atrial fibrillation (AF) compared with MVS alone.
Objectives This study identified risk factors and outcomes associated with PPM implantation in a randomized trial that evaluated ablation for AF in patients who underwent MVS.
Methods A total of 243 patients with AF and without previous PPM placement were randomly assigned to MVS alone (n = 117) or MVS + ablation (n = 126). Patients in the ablation group were further randomized to pulmonary vein isolation (PVI) (n = 62) or the biatrial maze procedure (n = 64). Using competing risk models, this study examined the association among PPM and baseline and operative risk factors, and the effect of PPM on time to discharge, readmissions, and 1-year mortality.
Results Thirty-five patients received a PPM within the first year (14.4%), 29 (83%) underwent implantation during the index hospitalization. The frequency of PPM implantation was 7.7% in patients randomized to MVS alone, 16.1% in MVS + PVI, and 25% in MVS + biatrial maze. The indications for PPM were similar among patients who underwent MVS with and without ablation. Ablation, multivalve surgery, and New York Heart Association functional (NYHA) functional class III/IV were independent risk factors for PPM implantation. Length of stay post-surgery was longer in patients who received PPMs, but it was not significant when adjusted for randomization assignment (MVS vs. ablation) and age (hazard ratio [HR]: 0.81; 95% confidence interval [CI]: 0.61 to 1.08; p = 0.14). PPM implantation did not increase 30-day readmission rate (HR: 1.43; 95% CI: 0.50 to 4.05; p = 0.50). The need for PPM was associated with a higher risk of 1-year mortality (HR: 3.21; 95% CI: 1.01 to 10.17; p = 0.05) after adjustment for randomization assignment, age, and NYHA functional class.
Conclusions AF ablation, multivalve surgery, and NYHA functional class III/IV were associated with an increased risk for permanent pacing. PPM implantation following MVS was associated with a significant increase in 1-year mortality. (Surgical Ablation Versus No Surgical Ablation for Patients With Atrial Fibrillation Undergoing Mitral Valve Surgery; NCT00903370)
The AF ablation trial was supported by a cooperative agreement (U01 HL088942) funded by the National Heart, Lung. and Blood Institute, the National Institutes of Neurological Disorders and Stroke of the National Institutes of Health (NIH) and the Canadian Institutes for Health Research (CIHR). The views expressed in this paper are those of the authors and do not necessarily represent the views of the National Heart, Lung, and Blood Institute; National Institutes of Health; or the United States Department of Health and Human Services. This trial was designed to evaluate ablation as a therapeutic approach, not to support FDA-approval for any individual device. Dr. Mack has been a principal investigator for Edwards Lifesciences and Abbott Vascular; and has been an Executive Board member for Medtronic. Dr. Gillinov has been a consultant for Edwards Lifesciences, Medtronic, AtriCure, Abbott, CryolLife, and ClearFlow; has received royalties and equity rights from ClearFlow; and has received institutional royalties from AtriCure. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. P.K. Shah, MD, served as Guest Editor-in-Chief for this paper. Fred Morady, MD, served as Guest Associate Editor for this paper.
Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.
- Received January 3, 2019.
- Revision received February 15, 2019.
- Accepted February 18, 2019.
- 2019 American College of Cardiology Foundation
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