- Patients with leaky heart valves due to severe ischemic mitral regurgitation had similar heart function and survival rates whether their mitral valve was repaired or replaced.
- Those with repaired valves had a greater risk of the leak returning.
DALLAS — People who had leaky mitral heart valves replaced because of severe ischemic mitral regurgitation fared about the same as those who had them repaired, according to a late-breaking clinical trial presented at the American Heart Association’s Scientific Sessions 2013.
The mitral valve controls blood from the heart’s upper left to lower left chambers, allowing blood to flow one direction through the heart and into the body.
Leaking mitral valves, often a complication from heart attack, allow blood to flow back into the heart’s upper left chamber — a condition known as ischemic mitral regurgitation. Consequences range from mild to severe, including heart failure or serious rhythm problems called arrhythmias.
“Practice guidelines recommend repairing or replacing mitral valves in severe cases, but there has been a lack of conclusive evidence that one approach is better than the other,” said Michael Acker, M.D., the William Maul Measey Professor of Surgery in the University of Pennsylvania’s Perelman School of Medicine and a clinical investigator with the Cardiothoracic Surgical Trials Network (CTSN).
While repair or replacement resulted in similar survival rates and addressed harmful structural changes in the left ventricle, repaired valves were more likely to leak again.
The CTSN Severe MR randomized trial was a two-year study of 251 patients with severe ischemic mitral valve regurgitation in 22 U.S. clinical centers. It compared 125 patients who underwent valve replacement to 126 who had their faulty valve repaired.
The study found:
- At one year, the death rate was 14.3 percent for the repair group and 17.6 percent for the replacement group.
- An index that measures improved left ventricle performance, or remodeling, was 53.6 ml/m2 in the repair group and 61 ml/m2 in the replacement group.
- Serious adverse events, functional status or quality of life weren’t significantly different between the two groups.
- There were no between-group differences in readmissions.
- The recurrence of mitral regurgitation at 12 months was 32.6 percent in the repair group and 2.3 percent in the replacement group.
- Three patients in the repair group underwent reoperation while none of the patients in the replacement group needed a repeat procedure.
“I think there is a bias in favor of valve repair versus replacement, so this information should be very helpful for cardiologists and surgeons in choosing an appropriate approach for this growing patient population,” Acker said.
Co-authors are: Michael K. Parides, Ph.D.; Louis P. Perrault, M.D.; Alan J. Moskowitz, M.D.; Annetine C. Gelijns, Ph.D.; Pierre Voisine, M.D.; Peter K. Smith, M.D.; Judy W. Hung, M.D.; Eugene Blackstone, M.D.; John D. Puskas, M.D.; Michael Argenziano, M.D.; James S. Gammie, M.D., Michael Mack, M.D., Deborah D. Ascheim, M.D., Emilia Bagiella, Ph.D., Ellen Moquete, R.N.; Bruce Ferguson, M.D.; Keith Horvath, M.D.; Nancy L. Geller Ph.D.; Marissa A. Miller, DVM.; Joseph Y. Woo, M.D.; David A D’Alessandro, M.D.; Gorav Ailawadi, M.D.; Francois Dagenais, M.D.; Timothy J. Gardner, M.D.; Patrick T. O’Gara, M.D.; Robert Michler, M.D.; Irving L. Kron, M.D., Disclosures
The CTSN is funded by the National Heart, Lung, and Blood Institute, the National Institute for Neurological Diseases and Stroke, and the Canadian Institutes for Health Research and InCHOIR, Icahn School of Medicine at Mount Sinai, served as the CTSN Coordinating Center.
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Note: Actual presentation is 11:29 a.m. CT/12:29 p.m. ET Monday, Nov. 18, 2013 in Hall E.