Data from a randomized clinical trial found no significant difference in patient outcomes after re-tightening the leaky mitral valve or replacing it with a prosthetic in patients with ischemic mitral regurgitation (IMR).
The trial, conducted by the Cardiothoracic Surgical Trials Network (CTSN), was the first to compare these two surgical approaches for IMR. Both options carry benefits and risks, but no study to date had evaluated the difference in patient outcomes.
The Severe Mitral Regurgitation study enrolled 251 patients across 22 centers diagnosed with severe IMR. Patients were then randomized to receive a procedure called annuloplasty (repair) or a prosthetic replacement mitral valve and were monitored at 1, 6, and 12 months post-procedure.
Researchers examined the shrinkage of the left ventricle in addition to various health outcomes and patient-assessed quality of life.
After the one year follow-up, there were almost no differences found in ventricle shrinkage or health outcomes between the two treatments. The only significant change was a higher rate of recurrent regurgitation in the repair group (32.6% of repair patients vs. 2.3% of replacement patients).
The SMR study will continue to monitor the participants long-term until they reach 24 months post-procedure.
The results of the SMR trial were published today in the New England Journal of Medicine.
For more information call (301) 592-8573 or visit the National Heart, Lung, and Blood Institute page.