Early Data Published for Edwards' Fortis TMVR Device

August 24, 2015—The feasibility, procedural, and 6-month follow-up results from the initial experience of transcatheter mitral valve replacement (TMVR) using the Fortis mitral transcatheter heart valve (Edwards Lifesciences) were published by Omar Abdul-Jawad Altisent, MD, et al in the Journal of the American College of Cardiology (JACC, 2015;66:1011–1019).

The data are from a series of three patients (mean age 71 ± 9 years, two men) who had TMVR under a compassionate clinical use program. All patients treated had functional mitral regurgitation (MR) secondary to ischemic cardiomyopathy (previous bypass surgery in all cases; left ventricular ejection fraction between 25% and 30%) and were considered to be at very high surgical risk (mean Society of Thoracic Surgeons score: 9.3).

As summarized in JACC, the procedures were performed through the transapical approach, and the valve was successfully implanted in all cases with no major complications. At hospital discharge, echocardiographic evaluation revealed trace residual MR in two patients and no MR in one patient. The mean transvalvular mitral gradient was ≤ 4 mm Hg in all patients. 

At the 3-month follow-up, the valve function remained unchanged, and transesophageal echocardiography and computed tomography showed no structural failures. All patients had improvements in functional status, in exercise capacity as evaluated by the 6-minute walk test, and in quality of life. The investigators reported that at 6-month follow-up, all patients were alive without hospital readmission for heart failure, and with New York Heart Association functional class ≤ 2.

It was concluded that TMVR with this valve is feasible and associated with good outcomes. Optimal valve functional results were obtained acutely and were sustained at 6-month follow-up in all patients. The investigators advised that further studies with a larger number of patients and longer follow-up are warranted.