Real-World Outcomes Evaluated With Edwards’ Pascal Edge-to-Edge TMVR System

November 24, 2020—Findings from a study that sought to characterize the real-world performance and clinical outcomes of the Pascal system (Edwards Lifesciences), a leaflet approximation device for transcatheter edge-to-edge mitral valve repair, demonstrated that the device effectively reduces mitral regurgitation (MR) and leads to functional improvements on short-term follow-up.

The study was presented at the 2020 PCR Valves eCourse that was held as a virtual conference on November 22-24 and published by Christian Besler, MD, et al in EuroIntervention (2020;16:824-832).

The study was composed of 50 patients who were treated for severe MR and followed-up for 1 month. These patients were New York Heart Association (NYHA) class II to IV despite optimal medical therapy. Patient characteristics included median age of 78 years (interquartile range [IQR], 74.5-81), 52% female, and log EuroSCORE 21.6 (IQR 13.2-30.2). Primary and secondary MR were present in 24% and 68% of patients, respectively, with mixed etiology observed in 8% of patients.

A one-device strategy was employed in 26 (52%) patients, a two-device strategy in 23 patients (46%) patients, and a three-device strategy in one (2%) patient. Technical success and procedural success were achieved in 100% and 98% of patients, respectively.

The investigators also reported the following:

• MR grade ≤ 1 was observed in 39 (78%) of 50 patients at discharge and in 36 (78%) of 46 patients at 1 month, with transvalvular gradients remaining ≤ 5 mm Hg in all patients.
• One device embolization and one single leaflet device attachment were observed during follow-up.
• After 1 month, 73% of patients reported an improvement in NYHA class, and 6-minute walk test distance increased by 73 ± 12 m in patients without relevant tricuspid regurgitation.