Transcatheter mitral valve replacement (TMVR) using a new self-expanding, tri-leaflet bovine valve was a success in the majority of patients enrolled in a pioneering global study, according to data presented this week at the Transcatheter Cardiovascular Therapeutics (TCT) symposium in Denver.
Mitral regurgitation is a common diagnosis associated with heart failure and poor prognosis, Paul Sorajja, MD, said at Nov. 1 press conference. Sorajja, alongside several colleagues, authored the study, that enrolled 50 subjects in an international trial that sought to bypass standard surgery and instead test the feasibility of a novel TMVR technique.
Between May 2015 and July 2017, Sorajja et al. recruited patients for the study, which was centered at John Paul II Hospital in Krakow, Poland, but reached across Europe and the Eastern U.S. Subjects had to exhibit symptomatic, severe mitral regurgitation, be deemed high or extreme risk for surgical procedures by a local heart team and have mild to no mitral valve calcification. Individuals who suffered from hemodynamic instability, needed additional valvular therapy or who had undergone prior MV surgery were excluded from the trial.
The researchers based the study around the “Intrepid” valve, Sorajja explained, which is a self-expanding, nitinol valve that is 43, 46 or 50 mm in diameter. The contraption houses a 27-mm tri-leaflet bovine valve and uses a transapical delivery system.
Of the 50 patients in the original cohort, seven died within 30 days of the TMVR procedure. An additional four died after the one-month marker. No patients experienced a disabling stroke or any myocardial infarction, according to the research, though seven experienced new-onset atrial fibrillation and five had to undergo reoperation for bleeding. A total of 12 subjects were eventually rehospitalized for heart failure, but the one-year survival rate in the group was a positive 76.5 percent.
Sorajja said 79 percent of patients fell into either the first or second class of the New York Heart Association Classification scale—a quality of life measure—during follow-up. He said the majority of patients saw symptom improvement, suggesting TMVR with the Intrepid valve is a feasible option for symptomatic patients at high surgical risk.
“It really speaks to a robust, usable procedure,” he said.
The team has embarked on its next steps, the APOLLO trial, in which the Intrepid system will be tested in a larger population. Successful implantation in the first APOLLO patient was announced Oct. 23.