Joseph J DeRose1, Donna M Mancini2, Helena L Chang3, Michael Argenziano4, François Dagenais5, Gorav Ailawadi6, Louis P Perrault7, Michael K Parides1, Wendy C Taddei-Peters8, Michael J Mack9, Donald D Glower10, Babatunde A Yerokun10, Pavan Atluri11, John C Mullen12, John D Puskas13, Karen O'Sullivan3, Nancy M Sledz3, Hugo Tremblay5, Ellen Moquete3, Bart S Ferket3, Alan J Moskowitz3, Alexander Iribarne14, Annetine C Gelijns3, Patrick T O'Gara15, Eugene H Blackstone16, A Marc Gillinov16. 1. Department of Cardiothoracic Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, New York, New York. 2. International 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. Electronic address: donna.mancini@mountsinai.org. 3. International 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. 4. Division of Cardiothoracic Surgery, Department of Surgery, College of Physicians and Surgeons, Columbia University, New York, New York. 5. Department of Surgery, Institut de Cardiologie et Pneumologie de Québec, Québec, Canada. 6. Section of Adult Cardiac Surgery, University of Virginia, Charlottesville, Virginia. 7. Department of Surgery, Montreal Heart Institute, Québec, Québec, Canada. 8. Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland. 9. Cardiovascular Surgery, Baylor Scott and White Health, Plano, Texas. 10. Department of Surgery, Duke University Medical Center, Durham, North Carolina. 11. Department of Surgery, University of Pennsylvania, Philadelphia, Pennsylvania. 12. Division of Cardiac Surgery, University of Alberta, Edmonton, Alberta, Canada. 13. Department of Cardiovascular Surgery, Mount Sinai Heart at Saint Luke's, New York, New York. 14. Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire. 15. Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts. 16. Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio.
Abstract
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).
RCT Entities:
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).
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