Key Points
- Transcatheter Tricuspid Valve Replacement with the EVOQUE valve is being studied in the TRISCEND study
- Patients with symptomatic, moderate to severe tricuspid regurgitation were evaluated for the TRISCEND study, a single-arm prospective multicenter study.
- At six months, there was sustained significant reduction in tricuspid regurgitation.
- Procedural complications were low, and mostly driven by severe bleeding.
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 a late-breaking clinical trial session at the 33rd annual Transcatheter Therapies Conference, Dr. Susheel Kodali, director of the Structural Heart & Valve Center at New York-Presbyterian/Columbia University Medical Center, presented the 6-month follow up results from the implantation of the EVOQUE valve, as part of the TRISCEND study.
The EVOQUE is a self-expanding, nitinol framed valve that 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. The 30 days results were previously reported, in which echocardiographic data revealed reduction of TR to trace, none or mild in 98% of patients.
Of 132 enrolled patients, six-month follow up data were available for 56. 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 96% of patients. The primary outcome was MACCE (major adverse cardiovascular and cerebral events) at 3 months, with up to a 5 year follow up.
At 6 months, major adverse events occurred in 18.5% of patients. This was mostly due to severe bleeding, which occurred in 22 (17.7%) of patients. Fatal bleeding occurred in one patient. New pacemakers were implanted in 10% of patients. Cardiovascular mortality occurred in one patient, and 2 patients had surgical reimplantation of their valve. Survival at six months was 96%, and freedom from heart failure hospitalization occurred in 94% of patients, which Dr. Kodali highlighted was a significant improvement for a cohort in which 35% had a heart failure hospitalization in the one year prior to valve implantation. Echocardiographic analysis at 30 days revealed reduction to none/trace or mild tricuspid regurgitation in 98% of patients. This continued to hold true at six months. All patients achieved at least 1 grade reduction in their TR and 98% achieved a reduction in ≥2 grade of 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 days when compared to baseline, and this continued to improve at six months.
After the presentation, Dr. Kodali admitted that patients with severe right ventricular dysfunction were excluded from the trial. He states that assessing RV function is difficult post-implantation, but preliminary review of data show improvement of RV Function at six months when compared to 30 days after implant. When deciding between tricuspid repair and replacement, Dr. Kodali stated “over the next decade we will have to figure out who will benefit from what, and which anatomic features play a role in that determination”. Dr. João L. Cavalcante (Abbott Northwestern, Minneapolis) agreed, stating “the right ventricle has to be primed for the procedure, and we know that some TR helps the right ventricle. What is impressive is how safe this valve appears to be in such a high-risk population.” Dr. Steven Bolling (University of Michigan, Ann Arbor) added that he thought patients needed to be treated sooner. “You can’t have a situation where you have a patient with one foot in the grave and the other on a banana peel, with massively dilated right ventricles and severe tricuspid regurgitation, and hope to improve their outcomes”.