Study Evaluates First-in-Human Experience With Edwards’ Evoque TTVR System

February 10, 2021—An observational first-in-human experience investigated the feasibility and safety of the Evoque transcatheter tricuspid valve replacement (TTVR) system (Edwards Lifesciences) and its impact on short-term clinical outcomes in patients with severe tricuspid regurgitation (TR). Neil P. Fam, MD, et al published the findings online in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.

The investigators concluded that the Evoque TTVR system demonstrated high technical success, acceptable safety, and significant clinical improvement. They advised that larger prospective studies are needed to confirm durability and safety and the impact on long-term clinical outcomes.

As summarized in JACC: Cardiovascular Interventions, the study was composed of 25 patients with severe TR who underwent Evoque TTVR in a compassionate use experience. The primary outcome was technical success, with New York Heart Association (NYHA) functional class, TR grade, and major adverse cardiac and cerebrovascular events assessed at 30-day follow-up.

All patients (mean age, 76 ± 3 years; 88% women) were at high surgical risk (mean Society of Thoracic Surgeons risk score, 9.1% ± 2.3%) with 96% in NYHA functional class III or IV. TR etiology was predominantly functional, with mean tricuspid annular diameter of 44.8 ± 7.8 mm and mean tricuspid annular plane systolic excursion of 16 ± 2 mm.

Technical success was 92%, with no intraprocedural mortality or conversion to surgery.

At 30-day follow-up, mortality was 0%, 76% of patients were in NYHA functional class I or II, and TR grade was ≤ 2 + in 96%. Major bleeding occurred in three patients (12%), two patients (8%) required pacemaker implantation, and one patient (4%) required dialysis, reported the investigators in JACC: Cardiovascular Interventions.