Short-Term Results Reported From German Multicenter Experience With Edwards’ Pascal TMVR Device

December 7, 2020—The report from a German multicenter experience with the new leaflet-based Pascal transcatheter mitral valve repair (TMVR) system (Edwards Lifesciences) for mitral regurgitation (MR) was published by Victor Mauri, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2020;13:2769-2778).

The aim of the study was to investigate the procedural and short-term safety and efficacy of the Pascal system, which received European CE Mark approval for the percutaneous treatment of patients with MR in February 2019. Novel characteristics include broad paddles positioned around a central spacer and the ability for independent leaflet capture, noted the investigators.

As summarized in JACC: Cardiovascular Interventions, procedural and 30-day outcomes were investigated in the first 309 patients with symptomatic MR 3+/4+ treated with the Pascal repair system at 10 sites. Primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAEs).

The study was composed of 309 patients (mean age 77 ± 10 years; 42% women; mean EuroSCORE II, 5.8±4.5%). Among these patients, MR etiology was degenerative in 33%, functional in 52%, and mixed in 16%. Additionally, 86% of patients were in New York Heart Association functional class III or IV.

The investigators reported in JACC: Cardiovascular Interventions that the technical success rate was 96%. Of the 308 patients discharged, MR was ≤ 2+ in 93.5%.

At 30 days, the MAE rate was 4.1%; the estimated all-cause mortality rate was 2%, and 72% of patients were in New York Heart Association functional class ≤ II (P < .001).

Additionally, rates of device success and CLASP–trial-defined clinical success were 81.9% and 86.9%, respectively. Single-leaflet device attachment occurred in seven patients (2.3%).

“Mitral valve repair with the Pascal system in the early postapproval phase was effective and safe, with high procedural success rates and low rates of MAE,” concluded the investigators in JACC: Cardiovascular Interventions. “MR was significantly reduced, accompanied by significant improvement in functional status.”