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N Engl J Med. 2016 May 19;374(20):1932-41. doi: 10.1056/NEJMoa1602003. Epub 2016 Apr 3.

Two-Year Outcomes of Surgical Treatment of Moderate Ischemic Mitral Regurgitation.

Collaborators (245)

Miller MA, Taddei-Peters WC, Buxton D, Caulder R, Geller NL, Gordon D, Jeffries NO, Lee A, Moy CS, Gombos IK, Ralph J, Weisel R, Gardner TJ, O'Gara PT, Rose EA, Gelijns AC, Parides MK, Ascheim DD, Moskowitz AJ, Bagiella E, Moquete E, Chang H, Chase M, Chen Y, Goldfarb S, Gupta L, Kirkwood K, Kumbarce E, Levitan R, O'Sullivan K, Overbey J, Santos M, Weglinski M, Williams P, Wood C, Ye X, Nielsen SL, Wiggers H, Malgaard H, Mack M, Adame T, Settele N, Adams J, Ryan W, Smith RL, Grayburn P, Chen FY, Nohria A, Cohn L, Shekar P, Aranki S, Couper G, Davidson M, Bolman R 3rd, Burgess A, Conboy D, Noiseux N, Stevens LM, Prieto I, Basile F, Dionne J, Fecteau J, Blackstone EH, Gillinov A, Lackner P, Berroteran L, Dolney D, Fleming S, Palumbo R, Whitman C, Sankovic K, Sweeney DK, Pattakos G, Clarke PA, Argenziano M, Williams M, Goldsmith L, Smith CR, Naka Y, Stewart A, Schwartz A, Bell D, Van Patten D, Sreekanth S, Smith PK, Alexander JH, Milano CA, Glower DD, Mathew JP, Harrison J, Welsh S, Berry MF, Parsa CJ, Tong BC, Williams JB, Ferguson T, Kypson AP, Rodriguez E, Harris M, Akers B, O'Neal A, Puskas JD, Thourani VH, Guyton R, Baer J, Baio K, Neill AA, Voisine P, Senechal M, Dagenais F, O'Connor K, Dussault G, Ballivian T, Keilani S, Speir AM, Magee P, Ad N, Keyte S, Dang M, Slaughter M, Headlee M, Moody H, Solankhi N, Birks E, Groh MA, Shell LE, Shepard SA, Trichon BH, Nanney T, Hampton LC, Michler RE, D'Alessandro DA, DeRose JJ Jr, Goldstein DJ, Bello R, Jakobleff W, Garcia M, Taub C, Spevak D, Swayze R, Perrault LP, Basmadjian AJ, Bouchard D, Carrier M, Cartier R, Pellerin M, Tanguay JF, El-Hamamsy I, Denault A, Lacharité J, Robichaud S, Horvath KA, Corcoran PC, Siegenthaler MP, Murphy M, Iraola M, Greenberg A, Sai-Sudhakar C, Hasan A, McDavid A, Kinn B, Pagé P, Sirois C, Latter D, Leong-Poi H, Bonneau D, Errett L, Peterson MD, Verma S, Feder-Elituv R, Cohen G, Joyner C, Fremes SE, Moussa F, Christakis G, Karkhanis R, Yau T, Farkouh M, Woo A, Cusimano RJ, David T, Feindel C, Garrard L, Fredericks S, Mociornita A, Mullen JC, Choy J, Meyer S, Kuurstra E, Gammie JS, Young CA, Beach D, Acker MA, Atluri P, Woo Y, Mayer ML, Bowdish M, Starnes VA, Shavalle D, Matthews R, Javadifar S, Romar L, Kron IL, Ailawadi G, Johnston K, Dent JM, Kern J, Keim J, Burks S, Gahring K, Bull DA, Desvigne-Nickens P, Dixon DO, Haigney M, Holubkov R, Jacobs A, Miller F, Murkin JM, Spertus J, Wechsler AS, Sellke F, McDonald CL, Byington R, Dickert N, Dixon DO, Ikonomidis JS, Williams DO, Yancy CW, Fang JC, Giannetti N, Richenbacher W, Rao V, Furie KL, Miller R, Pinney S, Roberts WC, Walsh MN, Keteyian SJ, Brawner CA, Aldred H, Hung J, Zeng X, Mathew JP, Browndyke J, Toulgoat-Dubois Y.

Author information

1
From the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center-Albert Einstein College of Medicine (R.E.M., J.J.D.), the International Center for Health Outcomes and Innovation Research (InCHOIR), Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (M.K.P., A.J.M., H.L.C., E.B., J.R.O., E.G.M., L.N.G., A.C.G.), the Division of Cardiothoracic Surgery, Department of Surgery, College of Physicians and Surgeons, Columbia University (M.A.), and the Department of Cardiac Surgery, Mount Sinai Health System (E.A.R., J.D.P.) - all in New York; the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University Medical Center, Durham, NC (P.K.S., C.A.M.); the Division of Thoracic and Cardiovascular Surgery, University of Virginia School of Medicine, Charlottesville (G.A., S.G.B.); the Clinical Research Unit, Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (V.T.); the Department of Surgery, Division of Cardiovascular Surgery, University of Pennsylvania School of Medicine, Philadelphia (M.A.A., P.A.); the Division of Cardiology, Massachusetts General Hospital (J.W.H.), and the Cardiovascular Division, Brigham and Women's Hospital (P.T.O.) - both in Boston; Montreal Heart Institute, University of Montreal, Montreal (L.P.P., I.E.-H.), Peter Munk Cardiac Centre and Division of Cardiovascular Surgery, Toronto General Hospital, University Health Network and the Division of Cardiac Surgery, University of Toronto, Toronto (R.D.W.), and Institut Universitaire de Cardiologie de Québec, Hôpital Laval, Quebec, QC (F.D., P.V.) - all in Canada; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic Foundation, Cleveland (A.M.G.); and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.) and Office of Biostatistics Research (N.J.), National Heart, Lung, and Blood Institute, Bethesda, and the Department of Surgery, University of Maryland Medical Cent

Abstract

BACKGROUND:

In a trial comparing coronary-artery bypass grafting (CABG) alone with CABG plus mitral-valve repair in patients with moderate ischemic mitral regurgitation, we found no significant difference in the left ventricular end-systolic volume index (LVESVI) or survival after 1 year. Concomitant mitral-valve repair was associated with a reduced prevalence of moderate or severe mitral regurgitation, but patients had more adverse events. We now report 2-year outcomes.

METHODS:

We randomly assigned 301 patients to undergo either CABG alone or the combined procedure. Patients were followed for 2 years for clinical and echocardiographic outcomes.

RESULTS:

At 2 years, the mean (±SD) LVESVI was 41.2±20.0 ml per square meter of body-surface area in the CABG-alone group and 43.2±20.6 ml per square meter in the combined-procedure group (mean improvement over baseline, -14.1 ml per square meter and -14.6 ml per square meter, respectively). The rate of death was 10.6% in the CABG-alone group and 10.0% in the combined-procedure group (hazard ratio in the combined-procedure group, 0.90; 95% confidence interval, 0.45 to 1.83; P=0.78). There was no significant between-group difference in the rank-based assessment of the LVESVI (including death) at 2 years (z score, 0.38; P=0.71). The 2-year rate of moderate or severe residual mitral regurgitation was higher in the CABG-alone group than in the combined-procedure group (32.3% vs. 11.2%, P<0.001). Overall rates of hospital readmission and serious adverse events were similar in the two groups, but neurologic events and supraventricular arrhythmias remained more frequent in the combined-procedure group.

CONCLUSIONS:

In patients with moderate ischemic mitral regurgitation undergoing CABG, the addition of mitral-valve repair did not lead to significant differences in left ventricular reverse remodeling at 2 years. Mitral-valve repair provided a more durable correction of mitral regurgitation but did not significantly improve survival or reduce overall adverse events or readmissions and was associated with an early hazard of increased neurologic events and supraventricular arrhythmias. (Funded by the National Institutes of Health and Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT00806988.).

PMID:
27040451
PMCID:
PMC4908820
DOI:
10.1056/NEJMoa1602003
[Indexed for MEDLINE]
Free PMC Article

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