Patients continue to see the benefits of transcatheter mitral valve replacement (TMVR) a full two years after treatment, according to new findings published in the Journal of the American College of Cardiology.
The study’s authors tracked each of the first 100 patients enrolled in the Expanded Clinical Study of the Tendyne Mitral Valve System for two years, describing their efforts as “the longest follow-up of the largest cohort of patients treated to date by TMVR.” The mean patient age was 74.7 years old and 69% of patients were men. All participants had originally presented with symptomatic severe mitral regurgitation (MR) and underwent TMVR with the Tendyne device manufactured by Abbott.
After 90 days, all-cause mortality was 17%. After two years, it was 39%. Also, heart failure hospitalizations dropped from 1.30 events per year before TMVR to 0.51 per year after two years.
The authors highlighted the fact that, after two years, 93.2% of surviving patients showed no signs of MR. Left ventricular ejection fraction and estimated right ventricular systolic pressure also saw significant drops after TMVR that held for the full two years.
The team did note that paravalvular leakage was seen in a small number of patients, but the team found no evidence of structural valve deterioration. Bleeding events, meanwhile, remain a complication clinicians must keep an eye on at all times.
“The incidence of major, extensive, life-threatening or fatal bleeding in this study was not trivial,” wrote lead author David W.M. Muller, MBBS, MD, a cardiologist at St. Vincent’s Hospital in Sydney, Australia, and colleagues. “Bleeding in the first three months was predominantly procedural but thereafter included intracranial and gastrointestinal bleeding, events more likely to occur in the presence of long-term oral anticoagulation. Although the study protocol did not mandate anticoagulation beyond three months postprocedurally, the majority of survivors (84.0%) remained anticoagulated at two-year follow-up.”
Overall, however, these two-year findings suggest that TMVR provides significant value for patients presenting with severe MR.
“The elimination of MR and improvements in functional status and quality-of-life measures noted at one year were sustained to two years,” the authors concluded. “Ongoing clinical studies will help define the patient cohorts most likely to benefit from this novel therapy.”
Read the full study here.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.