A transcatheter mitral valve repair (TMVR) with MitraClip has been commercially proven as a safe, effective treatment for symptomatic mitral regurgitation (MR) patients with prohibitive surgical risk, according to findings from the STS/ACC TVT Registry™ that were presented Sunday, March 15 at ACC.15 in San Diego, CA.

This late-breaking clinical trial (LBCT) studied all commercial TMVR cases with MitraClip included in the registry, for a total of 564 participants across 61 health care centers in the U.S. The study examined 30-day patient outcomes for procedural success, complications and device-related events.

Results show that the procedure was without complications in 91.8 percent and the primary therapeutic benefit of the procedure which is reduction in mitral regurgitation was achieved in 63.7 percent. Only 7.8 percent of patients experienced complications; 2.7 percent experienced device-related adverse events; and patient mortality was at 5.8 percent after the 30-day period.   

“Overall, procedure success rates were high, procedural complication and device-related event rates were low, and hospital stays were quite short at an average of three days,” Sorajja said. “In addition, 82 percent of the patients were discharged directly to home from the hospital with another 10 percent discharged directly to extended care. These results are remarkable, especially when one considers that these patients are elderly with significant morbidities.”

However, Sorajja did note that more long-term follow-up is needed to “address the clinical significance of residual MR in these and other TMVR-treated patients.” However, he said the current findings do provide considerable insight into the commercial use of TMVR in the U.S. “The [STS/ACC TVT] Registry will allow us to continue to collect and analyze data to improve our understanding of the impact of this treatment option,” he said. 

Clinical Topics: Cardiac Surgery, Cardiovascular Care Team, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Cardiac Surgery and VHD, Interventions and Structural Heart Disease, Mitral Regurgitation

Keywords: ACC Annual Scientific Session, National Cardiovascular Data Registries, Registries, Cardiac Surgical Procedures, Centers for Medicare and Medicaid Services, U.S., Heart, Heart Valve Diseases, Hemorrhage, Infarction, Mitral Valve, Mitral Valve Insufficiency, Mitral Valve Insufficiency, Stroke, STS/ACC TVT Registry, Thrombosis, United States Food and Drug Administration

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