Early Global Study Data Presented for Abbott's Investigational Tendyne Mitral Valve Replacement Device
June 4, 2018—Abbott Structural Heart announced that 30-day outcomes from the first 100 patients treated in a global study of the company's investigational Tendyne transcatheter mitral valve replacement (TMVR) system were presented at EuroPCR 2018 held May 22–25 in Paris, France.
According to the company, the results demonstrated that Tendyne is associated with a significant reduction of mitral regurgitation (MR) symptoms and low mortality rates at 30 days. The global study plans to enroll up to 350 adult patients with symptomatic MR who are not eligible for open heart surgery to repair or replace the mitral valve. The primary endpoints of the study are safety (defined as device success and freedom from device- and procedure-related serious adverse events) and performance (assessed by reduction in MR severity).
In these early results from the study, investigators successfully implanted the Tendyne system in 97 of the first 100 patients. Treated patients experienced a significant reduction in MR at 30 days, as well as improvements in symptoms based on New York Heart Association grade severity and the Kansas City Cardiomyopathy Questionnaire.
At baseline, 99% of patients enrolled had a MR grade of ≥ 3+, which at 30 days was reduced to none or trace in 98.7% of patients. Data showed a 97% implantation success rate with no associated deaths or strokes.
The 30-day results demonstrated low rates of serious adverse events and low mortality (6% vs 7.9% Society of Thoracic Surgeons score for predicted mortality for surgical valve replacement). This represented a favorable 0.76 ratio of observed-to-expected mortality (a measure of assumed patient deaths due to age or other comorbidities beyond a care team's control).
The study's Principal Investigator is David Muller, MBBS, MD, with St Vincent's Hospital in Sydney, Australia. In the company's announcement, Dr. Muller commented, "Treating people with severe mitral regurgitation can be challenging because of advanced age, frailty, or other complicating factors, and alternative treatments to surgery are needed. These new data on the Tendyne replacement valve offer early hope for patients who are not eligible for transcatheter valve repair or surgery to relieve symptoms."
According to the company, the Tendyne mitral replacement valve is repositionable and fully retrievable to allow for more precise implantation, helping improve patient outcomes.The Tendyne system is currently under clinical investigation in Europe, and Abbott expects to enroll the first patient in the United States pivotal trial in the coming months.