After six months of follow-up, all three patients in a recent trial who underwent transcatheter mitral valve replacement (TMVR) to treat mitral valve disease remained alive and were not readmitted to hospitals for heart failure.

The patients were treated with the Fortis mitral transcatheter heart valve, which is not FDA-approved. Edwards Lifesciences, the device’s manufacturer, announced in May that it had temporarily paused enrollment in the Fortis clinical program while the company investigated reports of valve thrombus.

Lead researcher Omar Abdul-Jawad Altisent, MD, of the Quebec Heart and Lung Institute in Canada, and colleagues published their results online in the Journal of the American College of Cardiology on Aug. 24.

The three patients (two men and one woman) had a history of coronary artery disease, symptomatic ischemic cardiomyopathy and isolated severe mitral regurgitation and New York Heart Association (NYHA) functional class III or IV heart failure despite receiving optimal medical treatment. They had previously undergone CABG and been admitted to the hospital for heart failure within the six months before undergoing TMVR. They were also considered to be at very high risk for standard surgical valve repair or replacement.

Patients had a clinical visit and underwent a transthoracic echocardiography examination at the 1- to 3-month and 6-month follow-ups as well as a transesophageal echocardiography and 3-dimensional CT exam at the 3-month follow-up visit.

In all three cases, the valve was successfully implanted and was not associated with any major complications. Two of the patients had trace residual mitral regurgitation when discharged from the hospital, while the other patient had no mitral regurgitation at discharge. In addition, the mean transvalvular mitral gradient was 4 mm hG or less in each of the three patients.

After three months, all patients had no structural failures, had maintained their valve function and had improvements in functional status, exercise capacity and quality of life.

At six months, the patients were alive, had not been hospitalized for heart failure and had NYHA functional class II or lower heart failure.

After patients undergo TMVR, there is no evidence on the most appropriate antithrombotic treatment, according to the researchers. However, based on the Fortis program being halted because of valve thrombus, the researchers noted a strict anticoagulation regimen might be necessary after TMVR.

“Continued advancements in anatomical evaluation, technical ease, pre-procedural planning, and post-procedural management will play an important role in the success of TMVR procedures,” the researchers wrote. “Further studies are warranted.”