December 4, 2013 — The Cardiothoracic Surgical Trials Network (CTSN), whose Data and Clinical Coordinating Center is at Icahn School of Medicine at Mount Sinai, is reporting evidence on whether or not there is any significant difference between the two current surgical approaches to treat patients with severe ischemic mitral regurgitation: mitral valve repair and mitral valve replacement.
The findings, presented Nov. 18 at the American Heart Association’s (AHA’S) Scientific Sessions 2013 and published simultaneously by the New England Journal of Medicine (NEJM), report similar clinical outcomes one-year following mitral valve surgery for both surgical approaches. Although patient clinical outcomes were similar, mitral valve replacement was shown to be more durable than repair.
"While the medical community has traditionally gravitated towards valve repair as a preferred treatment option, the evidence in this study does not suggest that mitral valve repair is superior," said Michael Acker, M.D., chief, Division of Cardiovascular Surgery, director, Penn Medicine Heart and Vascular Center, and lead author of the study. "Further patient follow-up is needed to confirm the findings of this trial, but we believe these results should be very helpful for cardiologists and surgeons in choosing an appropriate approach for this growing patient population."
“Ischemic mitral regurgitation is an important public health problem affecting as many as two million Americans. Our study is the first definitive clinical trial to address the relative merits of mitral valve repair versus mitral valve replacement surgery in patients suffering from severe ischemic mitral regurgitation,” said Annetine Gelijns, Ph.D., professor and chair, department of health evidence and policy, Icahn School of Medicine at Mount Sinai, corresponding author for the NEJM study and principal investigator for the Data and Clinical Coordinating Center based at Mount Sinai for the NIH-sponsored Cardiothoracic Surgical Trials Network (CTSN), which conducted the clinical trial study.
If not surgically corrected, ischemic mitral regurgitation has been reported to potentially have a one-year mortality risk as high as 40 percent. Currently, practice guidelines recommend valve repair or replacement for severe ischemic mitral regurgitation. However, lack of evidence has led to uncertainty and variation in surgical practice, although surgeons’ use of repair has increased over time.
Previous research has shown mitral valve repair has lower operative mortality and complications, while mitral valve replacement may provide better long-term correction of mitral regurgitation.
“These results may impact the surgical care of patients experiencing severe ischemic mitral regurgitation and offer the strongest evidence to date to inform future surgical practice guidelines,” said Michael Parides, Ph.D., professor of biostatistics, department of health evidence and policy, Icahn School of Medicine at Mount Sinai, and principal statistician, CTSN.
The multicenter, randomized clinical trial included 22 clinical centers in North America randomizing 251 patients. It evaluated the safety and effectiveness of mitral valve repair and mitral valve replacement in patients with severe ischemic mitral regurgitation. Comparative effectiveness was based on the degree of left ventricular remodeling, mortality, adverse events, recurrent mitral regurgitation, hospitalizations, and quality of life one year after surgery.
“While our study results clearly demonstrate that patient outcomes with replacement and repair are similar one-year after surgery, our ongoing patient follow-up is extremely important, as it will reveal any consequences for patients whose mitral regurgitation has recurred,” said Alan Moskowitz, M.D., professor and vice chair, department of health evidence and policy, Icahn School of Medicine at Mount Sinai and study co-author.
As principal investigator for CTSN’s Data and Clinical Coordinating Center based at Mount Sinai, Gelijns previously received financial compensation as a consultant for InHealth’s Research Council, a not-for-profit agency which has supported some of the study-related analyses.
This study was presented as the Late-Breaking Clinical Trial (Abstract 19636): Severe Ischemic Mitral Regurgitation: Is it Better to Repair or Replace the Valve? It was also presented at the 2013 Scientific Sessions of the American Heart Association (AHA) by by researchers at the Perelman School of Medicine at the University of Pennsylvania. A total of 22 centers conducted the study.
For more information: www.mountsinai.org