Transcatheter mitral valve replacement feasible in patients with mitral regurgitation
medwireNews: Transcatheter mitral valve replacement (TMVR) using a prosthesis designed for the mitral valve is feasible in patients with mitral regurgitation (MR) at high surgical risk, preliminary trial results suggest.
“This intervention may help address an unmet need in patients at high risk for surgery,” say researcher David Muller (St. Vincent’s Hospital, Sydney, New South Wales, Australia) and colleagues.
In the Early Feasibility Study of the Tendyne Mitral Valve System, 30 patients with symptomatic MR and multiple comorbidities underwent transapical TMVR with a self-expanding nitinol prosthesis supporting a trileaflet porcine pericardial valve (Abbott Vascular, Roseville, Minnesota, USA). The mean age of the patients was 75.6 years, and 83.3% were male.
Overall, 86.7% of patients underwent successful device implantation without cardiovascular death, stroke, or device dysfunction at 30 days, and 83.3% were free from major adverse events. One patient died during the course of the trial due to hospital-acquired pneumonia and respiratory failure.
MR severity was measured as grade 4 in 93.1% and grade 3 in 6.9% of patients at baseline. At 30 days after TMVR, repeat transthoracic echocardiography was carried out in 26 of 27 surviving patients who underwent successful prosthesis implantation. Residual MR was grade 0 in 96.2% of these patients.
The authors report a “low rate” of major adverse events during the study period; none of the patients experienced stroke or myocardial infarction. Three participants required blood transfusion for access-site bleeding, one required transfusion for paravalvular leak-related hemolysis, and five experienced acute renal insufficiency, three of whom had existing chronic renal impairment.
After a mean of 9.7 days, 65.5% of patients were discharged home, while the remainder were transferred to a care facility for further rehabilitation.
“If these findings are confirmed with further study, TMVR may become an established therapy for selected patients with native mitral valve regurgitation,” the researchers write in the Journal of the American College of Cardiology.
However, the authors of an accompanying commentary, Howard Herrmann (University of Pennsylvania, Philadelphia, USA) and W Randolph Chitwood Jr (East Carolina University, Greenville, North Carolina, USA), note that the transapical approach has been associated with adverse outcomes in studies of transcatheter aortic valve replacement, and “it is likely that the search will continue for a less invasive (e.g., trans-septal or direct atrial) approach, which, if successful, could become a preferred access.”
The study authors conclude that larger, longer-term studies are needed to confirm the generalizability of their findings and “better characterize the utility of TMVR as an alternative to surgery for patients with severe, symptomatic MR.”
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