Two-year outcomes of surgical treatment of severe ischemic mitral regurgitation

D. Goldstein; A. J. Moskowitz; A. C. Gelijns; G. Ailawadi; M. K. Parides; L. P. Perrault; J. W. Hung; P. Voisine; F. Dagenais; A. M. Gillinov; V. Thourani; M. Argenziano; J. S. Gammie; M. Mack; P. Demers; P. Atluri; E. A. Rose; K. O'Sullivan; D. L. Williams; E. Bagiella; R. E. Michler; R. D. Weisel; M. A. Miller; N. L. Geller; W. C. Taddei-Peters; P. K. Smith; E. Moquete; J. R. Overbey; I. L. Kron; P. T. O'Gara; M. A. Acker

doi:10.1056/NEJMoa1512913

Two-year outcomes of surgical treatment of severe ischemic mitral regurgitation

D. Goldstein, A. J. Moskowitz, A. C. Gelijns, G. Ailawadi, M. K. Parides, L. P. Perrault, J. W. Hung, P. Voisine, F. Dagenais, A. M. Gillinov, V. Thourani, M. Argenziano, J. S. Gammie, M. Mack, P. Demers, P. Atluri, E. A. Rose, K. O'Sullivan, D. L. Williams, E. BagiellaR. E. Michler, R. D. Weisel, M. A. Miller, N. L. Geller, W. C. Taddei-Peters, P. K. Smith, E. Moquete, J. R. Overbey, I. L. Kron, P. T. O'Gara, M. A. Acker

Cardiovascular & Thoracic Surgery

Research output: Contribution to journal › Article › peer-review

378 Scopus citations

Abstract

BACKGROUND: In a randomized trial comparing mitral-valve repair with mitral-valve replacement in patients with severe ischemic mitral regurgitation, we found no significant difference in the left ventricular end-systolic volume index (LVESVI), survival, or adverse events at 1 year after surgery. However, patients in the repair group had significantly more recurrences of moderate or severe mitral regurgitation. We now report the 2-year outcomes of this trial. METHODS: We randomly assigned 251 patients to mitral-valve repair or replacement. Patients were followed for 2 years, and clinical and echocardiographic outcomes were assessed. RESULTS: Among surviving patients, the mean (±SD) 2-year LVESVI was 52.6±27.7 ml per square meter of body-surface area with mitral-valve repair and 60.6±39.0 ml per square meter with mitral-valve replacement (mean changes from baseline, -9.0 ml per square meter and -6.5 ml per square meter, respectively). Two-year mortality was 19.0% in the repair group and 23.2% in the replacement group (hazard ratio in the repair group, 0.79; 95% confidence interval, 0.46 to 1.35; P=0.39). The rank-based assessment of LVESVI at 2 years (incorporating deaths) showed no significant between-group difference (z score=-1.32, P=0.19). The rate of recurrence of moderate or severe mitral regurgitation over 2 years was higher in the repair group than in the replacement group (58.8% vs. 3.8%, P<0.001). There were no significant between-group differences in rates of serious adverse events and overall readmissions, but patients in the repair group had more serious adverse events related to heart failure (P=0.05) and cardiovascular readmissions (P=0.01). On the Minnesota Living with Heart Failure questionnaire, there was a trend toward greater improvement in the replacement group (P=0.07). CONCLUSIONS: In patients undergoing mitral-valve repair or replacement for severe ischemic mitral regurgitation, we observed no significant between-group difference in left ventricular reverse remodeling or survival at 2 years. Mitral regurgitation recurred more frequently in the repair group, resulting in more heart-failure-related adverse events and cardiovascular admissions.

Original language	English (US)
Pages (from-to)	344-353
Number of pages	10
Journal	New England Journal of Medicine
Volume	374
Issue number	4
DOIs	https://doi.org/10.1056/NEJMoa1512913
State	Published - Jan 28 2016

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Medicine(all)

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Goldstein, D., Moskowitz, A. J., Gelijns, A. C., Ailawadi, G., Parides, M. K., Perrault, L. P., Hung, J. W., Voisine, P., Dagenais, F., Gillinov, A. M., Thourani, V., Argenziano, M., Gammie, J. S., Mack, M., Demers, P., Atluri, P., Rose, E. A., O'Sullivan, K., Williams, D. L., ... Acker, M. A. (2016). Two-year outcomes of surgical treatment of severe ischemic mitral regurgitation. New England Journal of Medicine, 374(4), 344-353. https://doi.org/10.1056/NEJMoa1512913

Two-year outcomes of surgical treatment of severe ischemic mitral regurgitation. / Goldstein, D.; Moskowitz, A. J.; Gelijns, A. C.; Ailawadi, G.; Parides, M. K.; Perrault, L. P.; Hung, J. W.; Voisine, P.; Dagenais, F.; Gillinov, A. M.; Thourani, V.; Argenziano, M.; Gammie, J. S.; Mack, M.; Demers, P.; Atluri, P.; Rose, E. A.; O'Sullivan, K.; Williams, D. L.; Bagiella, E.; Michler, R. E.; Weisel, R. D.; Miller, M. A.; Geller, N. L.; Taddei-Peters, W. C.; Smith, P. K.; Moquete, E.; Overbey, J. R.; Kron, I. L.; O'Gara, P. T.; Acker, M. A.

In: New England Journal of Medicine, Vol. 374, No. 4, 28.01.2016, p. 344-353.

Research output: Contribution to journal › Article › peer-review

Goldstein, D, Moskowitz, AJ, Gelijns, AC, Ailawadi, G, Parides, MK, Perrault, LP, Hung, JW, Voisine, P, Dagenais, F, Gillinov, AM, Thourani, V, Argenziano, M, Gammie, JS, Mack, M, Demers, P, Atluri, P, Rose, EA, O'Sullivan, K, Williams, DL, Bagiella, E, Michler, RE, Weisel, RD, Miller, MA, Geller, NL, Taddei-Peters, WC, Smith, PK, Moquete, E, Overbey, JR, Kron, IL, O'Gara, PT & Acker, MA 2016, 'Two-year outcomes of surgical treatment of severe ischemic mitral regurgitation', New England Journal of Medicine, vol. 374, no. 4, pp. 344-353. https://doi.org/10.1056/NEJMoa1512913

Goldstein, D. ; Moskowitz, A. J. ; Gelijns, A. C. ; Ailawadi, G. ; Parides, M. K. ; Perrault, L. P. ; Hung, J. W. ; Voisine, P. ; Dagenais, F. ; Gillinov, A. M. ; Thourani, V. ; Argenziano, M. ; Gammie, J. S. ; Mack, M. ; Demers, P. ; Atluri, P. ; Rose, E. A. ; O'Sullivan, K. ; Williams, D. L. ; Bagiella, E. ; Michler, R. E. ; Weisel, R. D. ; Miller, M. A. ; Geller, N. L. ; Taddei-Peters, W. C. ; Smith, P. K. ; Moquete, E. ; Overbey, J. R. ; Kron, I. L. ; O'Gara, P. T. ; Acker, M. A. / Two-year outcomes of surgical treatment of severe ischemic mitral regurgitation. In: New England Journal of Medicine. 2016 ; Vol. 374, No. 4. pp. 344-353.

@article{f16242593f5948549673fd429bbc08c5,

title = "Two-year outcomes of surgical treatment of severe ischemic mitral regurgitation",

abstract = "BACKGROUND: In a randomized trial comparing mitral-valve repair with mitral-valve replacement in patients with severe ischemic mitral regurgitation, we found no significant difference in the left ventricular end-systolic volume index (LVESVI), survival, or adverse events at 1 year after surgery. However, patients in the repair group had significantly more recurrences of moderate or severe mitral regurgitation. We now report the 2-year outcomes of this trial. METHODS: We randomly assigned 251 patients to mitral-valve repair or replacement. Patients were followed for 2 years, and clinical and echocardiographic outcomes were assessed. RESULTS: Among surviving patients, the mean (±SD) 2-year LVESVI was 52.6±27.7 ml per square meter of body-surface area with mitral-valve repair and 60.6±39.0 ml per square meter with mitral-valve replacement (mean changes from baseline, -9.0 ml per square meter and -6.5 ml per square meter, respectively). Two-year mortality was 19.0% in the repair group and 23.2% in the replacement group (hazard ratio in the repair group, 0.79; 95% confidence interval, 0.46 to 1.35; P=0.39). The rank-based assessment of LVESVI at 2 years (incorporating deaths) showed no significant between-group difference (z score=-1.32, P=0.19). The rate of recurrence of moderate or severe mitral regurgitation over 2 years was higher in the repair group than in the replacement group (58.8% vs. 3.8%, P<0.001). There were no significant between-group differences in rates of serious adverse events and overall readmissions, but patients in the repair group had more serious adverse events related to heart failure (P=0.05) and cardiovascular readmissions (P=0.01). On the Minnesota Living with Heart Failure questionnaire, there was a trend toward greater improvement in the replacement group (P=0.07). CONCLUSIONS: In patients undergoing mitral-valve repair or replacement for severe ischemic mitral regurgitation, we observed no significant between-group difference in left ventricular reverse remodeling or survival at 2 years. Mitral regurgitation recurred more frequently in the repair group, resulting in more heart-failure-related adverse events and cardiovascular admissions.",

author = "D. Goldstein and Moskowitz, {A. J.} and Gelijns, {A. C.} and G. Ailawadi and Parides, {M. K.} and Perrault, {L. P.} and Hung, {J. W.} and P. Voisine and F. Dagenais and Gillinov, {A. M.} and V. Thourani and M. Argenziano and Gammie, {J. S.} and M. Mack and P. Demers and P. Atluri and Rose, {E. A.} and K. O'Sullivan and Williams, {D. L.} and E. Bagiella and Michler, {R. E.} and Weisel, {R. D.} and Miller, {M. A.} and Geller, {N. L.} and Taddei-Peters, {W. C.} and Smith, {P. K.} and E. Moquete and Overbey, {J. R.} and Kron, {I. L.} and O'Gara, {P. T.} and Acker, {M. A.}",

note = "Funding Information: Supported by a cooperative agreement (U01 HL088942) funded by the National Heart, Lung, and Blood Institute and the National Institute of Neurological Disorders and Stroke of the NIH and the Canadian Institutes of Health Research. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.",

year = "2016",

month = jan,

day = "28",

doi = "10.1056/NEJMoa1512913",

language = "English (US)",

volume = "374",

pages = "344--353",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachussetts Medical Society",

number = "4",

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TY - JOUR

T1 - Two-year outcomes of surgical treatment of severe ischemic mitral regurgitation

AU - Goldstein, D.

AU - Moskowitz, A. J.

AU - Gelijns, A. C.

AU - Ailawadi, G.

AU - Parides, M. K.

AU - Perrault, L. P.

AU - Hung, J. W.

AU - Voisine, P.

AU - Dagenais, F.

AU - Gillinov, A. M.

AU - Thourani, V.

AU - Argenziano, M.

AU - Gammie, J. S.

AU - Mack, M.

AU - Demers, P.

AU - Atluri, P.

AU - Rose, E. A.

AU - O'Sullivan, K.

AU - Williams, D. L.

AU - Bagiella, E.

AU - Michler, R. E.

AU - Weisel, R. D.

AU - Miller, M. A.

AU - Geller, N. L.

AU - Taddei-Peters, W. C.

AU - Smith, P. K.

AU - Moquete, E.

AU - Overbey, J. R.

AU - Kron, I. L.

AU - O'Gara, P. T.

AU - Acker, M. A.

N1 - Funding Information: Supported by a cooperative agreement (U01 HL088942) funded by the National Heart, Lung, and Blood Institute and the National Institute of Neurological Disorders and Stroke of the NIH and the Canadian Institutes of Health Research. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

PY - 2016/1/28

Y1 - 2016/1/28

N2 - BACKGROUND: In a randomized trial comparing mitral-valve repair with mitral-valve replacement in patients with severe ischemic mitral regurgitation, we found no significant difference in the left ventricular end-systolic volume index (LVESVI), survival, or adverse events at 1 year after surgery. However, patients in the repair group had significantly more recurrences of moderate or severe mitral regurgitation. We now report the 2-year outcomes of this trial. METHODS: We randomly assigned 251 patients to mitral-valve repair or replacement. Patients were followed for 2 years, and clinical and echocardiographic outcomes were assessed. RESULTS: Among surviving patients, the mean (±SD) 2-year LVESVI was 52.6±27.7 ml per square meter of body-surface area with mitral-valve repair and 60.6±39.0 ml per square meter with mitral-valve replacement (mean changes from baseline, -9.0 ml per square meter and -6.5 ml per square meter, respectively). Two-year mortality was 19.0% in the repair group and 23.2% in the replacement group (hazard ratio in the repair group, 0.79; 95% confidence interval, 0.46 to 1.35; P=0.39). The rank-based assessment of LVESVI at 2 years (incorporating deaths) showed no significant between-group difference (z score=-1.32, P=0.19). The rate of recurrence of moderate or severe mitral regurgitation over 2 years was higher in the repair group than in the replacement group (58.8% vs. 3.8%, P<0.001). There were no significant between-group differences in rates of serious adverse events and overall readmissions, but patients in the repair group had more serious adverse events related to heart failure (P=0.05) and cardiovascular readmissions (P=0.01). On the Minnesota Living with Heart Failure questionnaire, there was a trend toward greater improvement in the replacement group (P=0.07). CONCLUSIONS: In patients undergoing mitral-valve repair or replacement for severe ischemic mitral regurgitation, we observed no significant between-group difference in left ventricular reverse remodeling or survival at 2 years. Mitral regurgitation recurred more frequently in the repair group, resulting in more heart-failure-related adverse events and cardiovascular admissions.

AB - BACKGROUND: In a randomized trial comparing mitral-valve repair with mitral-valve replacement in patients with severe ischemic mitral regurgitation, we found no significant difference in the left ventricular end-systolic volume index (LVESVI), survival, or adverse events at 1 year after surgery. However, patients in the repair group had significantly more recurrences of moderate or severe mitral regurgitation. We now report the 2-year outcomes of this trial. METHODS: We randomly assigned 251 patients to mitral-valve repair or replacement. Patients were followed for 2 years, and clinical and echocardiographic outcomes were assessed. RESULTS: Among surviving patients, the mean (±SD) 2-year LVESVI was 52.6±27.7 ml per square meter of body-surface area with mitral-valve repair and 60.6±39.0 ml per square meter with mitral-valve replacement (mean changes from baseline, -9.0 ml per square meter and -6.5 ml per square meter, respectively). Two-year mortality was 19.0% in the repair group and 23.2% in the replacement group (hazard ratio in the repair group, 0.79; 95% confidence interval, 0.46 to 1.35; P=0.39). The rank-based assessment of LVESVI at 2 years (incorporating deaths) showed no significant between-group difference (z score=-1.32, P=0.19). The rate of recurrence of moderate or severe mitral regurgitation over 2 years was higher in the repair group than in the replacement group (58.8% vs. 3.8%, P<0.001). There were no significant between-group differences in rates of serious adverse events and overall readmissions, but patients in the repair group had more serious adverse events related to heart failure (P=0.05) and cardiovascular readmissions (P=0.01). On the Minnesota Living with Heart Failure questionnaire, there was a trend toward greater improvement in the replacement group (P=0.07). CONCLUSIONS: In patients undergoing mitral-valve repair or replacement for severe ischemic mitral regurgitation, we observed no significant between-group difference in left ventricular reverse remodeling or survival at 2 years. Mitral regurgitation recurred more frequently in the repair group, resulting in more heart-failure-related adverse events and cardiovascular admissions.

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