Mitral-Valve Repair versus Replacement for Severe Ischemic Mitral Regurgitation

Пластика или протезирование митрального клапана при тяжелой ишемической митральной регургитации
Patrick T. O’Gara, Eugene H. Blackstone, James S. Gammie, Timothy J. Gardner, Irving L. Kron, Y. Joseph Woo, Michael J. Mack, Emilia Bagiella, Alan J. Moskowitz, Annetine C. Gelijns, Louis P. Perrault, Judy Hung, John D. Puskas, Deborah D. Ascheim, Peter K. Smith, Nancy L. Geller, Michael Argenziano, Robert E. Michler, T. Bruce Ferguson, Michael A. Acker, Michael K. Parides, Keith A. Horvath, Gorav Ailawadi, François Dagenais, Pierre Voisine, Ellen Moquete, Marissa A. Miller, David A. D’Alessandro
2013-11-18

LVESVIchordal-sparing replacementischemic mitral regurgitationleft ventricular reverse remodelingmitral-valve repair
BACKGROUND: Ischemic mitral regurgitation is associated with a substantial risk of death. Practice guidelines recommend surgery for patients with a severe form of this condition but acknowledge that the supporting evidence for repair or replacement is limited. METHODS: We randomly assigned 251 patients with severe ischemic mitral regurgitation to undergo either mitral-valve repair or chordal-sparing replacement in order to evaluate efficacy and safety. The primary end point was the left ventricular end-systolic volume index (LVESVI) at 12 months, as assessed with the use of a Wilcoxon rank-sum test in which deaths were categorized below the lowest LVESVI rank. RESULTS: At 12 months, the mean LVESVI among surviving patients was 54.6±25.0 ml per square meter of body-surface area in the repair group and 60.7±31.5 ml per square meter in the replacement group (mean change from baseline, -6.6 and -6.8 ml per square meter, respectively). The rate of death was 14.3% in the repair group and 17.6% in the replacement group (hazard ratio with repair, 0.79; 95% confidence interval, 0.42 to 1.47; P=0.45 by the log-rank test). There was no significant between-group difference in LVESVI after adjustment for death (z score, 1.33; P=0.18). The rate of moderate or severe recurrence of mitral regurgitation at 12 months was higher in the repair group than in the replacement group (32.6% vs. 2.3%, P<0.001). There were no significant between-group differences in the rate of a composite of major adverse cardiac or cerebrovascular events, in functional status, or in quality of life at 12 months. CONCLUSIONS: We observed no significant difference in left ventricular reverse remodeling or survival at 12 months between patients who underwent mitral-valve repair and those who underwent mitral-valve replacement. Replacement provided a more durable correction of mitral regurgitation, but there was no significant between-group difference in clinical outcomes. (Funded by the National Institutes of Health and the Canadian Institutes of Health; ClinicalTrials.gov number, NCT00807040.).
1
In 251 patients with severe ischemic mitral regurgitation, repair and chordal-sparing replacement produced no significant difference in LVESVI at 12 months.
2
Mitral-valve replacement provided more durable correction of regurgitation, without demonstrating superior overall clinical outcomes at 12 months.
3
Moderate or severe recurrent mitral regurgitation was substantially more frequent after repair than replacement (32.6% vs. 2.3%; P<0.001).
4
Repair and replacement showed no significant differences in major adverse cardiac or cerebrovascular events, functional status, or quality of life at 12 months.
5
Twelve-month mortality was 14.3% after repair versus 17.6% after replacement, with no statistically significant survival difference.

patients with severe ischemic mitral regurgitation undergoing mitral-valve repair or chordal-sparing replacement

comparative efficacy, safety, left ventricular reverse remodeling, survival, and durability of mitral-regurgitation correction

Publication Details
Publication Date
2013-11-18
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Authors
Patrick T. O’Gara
Eugene H. Blackstone
James S. Gammie
Timothy J. Gardner
Irving L. Kron
Y. Joseph Woo
Michael J. Mack
Emilia Bagiella
Alan J. Moskowitz
Annetine C. Gelijns
Louis P. Perrault
Judy Hung
John D. Puskas
Deborah D. Ascheim
Peter K. Smith
Nancy L. Geller
Michael Argenziano
Robert E. Michler
T. Bruce Ferguson
Michael A. Acker
Michael K. Parides
Keith A. Horvath
Gorav Ailawadi
François Dagenais
Pierre Voisine
Ellen Moquete
Marissa A. Miller
David A. D’Alessandro
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