Transcatheter tricuspid valve replacement has become a feasible alternative to surgery in patients deemed to be at high risk of adverse events, and in the past decade, various devices have been designed to meet this clinical need. In his Focused Clinical Research session on the opening day of the American College of Cardiology 2021 Scientific Sessions, Dr. Susheel Kodali, director of the Structural Heart & Valve Center at New York-Presbyterian/ Columbia University Medical Center presented the 30-day results from the implantation of the EVOQUE valve, as part of the TRISCEND study.
The self-expanding, nitinol frame valve is implanted via a 28 French transfemoral venous delivery system and is designed to engage the leaflets and annulus to remain secure. In this single arm, prospective, multicenter study, patients with symptomatic, moderate to severe tricuspid regurgitation were evaluated for implantation of the EVOQUE valve. At 30 days, the endpoints of interest were device and procedural success, reduction of TR, and a composite of major adverse events.
Of 56 enrolled patients, follow up data are available for 47. The mean age was 79, with severe TR and atrial fibrillation in greater than 90% of patents. Patients underwent device replacement for both functional and degenerative tricuspid regurgitation, and the procedure was a success in 98% of patients.
At 30 days, cardiovascular mortality occurred in one patient. Severe bleeding occurred in 22.6% of patients, and 2 patients had surgical reimplantation of their valve. Echocardiographic analysis at 30 days revealed reduction to none/trace or mild tricuspid regurgitation in 98% of patients. All patients achieved at least 1 grade reduction in their TR. There was a significant improvement in New York Heart Association class, 6-meter walk time, and Kansas City Cardiomyopathy Questionnaire score in patients at 30 days when compared to baseline.
After the presentation, Dr. Kodali admitted that the novelty of tricuspid valve interventions demands more understanding of the interaction between the tricuspid valve and the right ventricle. “One of the big challenges about this population is right ventricular dysfunction, and we struggle to understand whether the RV will tolerate the removal of this pop off valve,” he stated, alluding to the moderate and severe RV dysfunction seen immediately after valve implantation in 25% patients. These concerns mimic the early concerns of transcatheter mitral valve repair for severe mitral regurgitation, and Dr. Kodali is optimistic that ongoing trials, including the TRISCEND trial, will answer these questions.