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June 11, 2020

Early Results Published From Real-World Experience With Pascal System for Transcatheter Edge-to-Edge Mitral Valve Repair

June 11, 2020—Online in EuroIntervention, Christian Besler, MD, et al published early results from a real-world series evaluating transcatheter edge-to-edge mitral valve repair with the Pascal system (Edwards Lifesciences). The study sought to characterize the real-world performance and clinical outcomes of the Pascal system, which is a leaflet approximation device for transcatheter mitral valve repair.

As summarized in EuroIntervention, the study was composed of 50 patients in 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).

Patients were treated for severe mitral regurgitation (MR) and followed up for 1 month. Primary and secondary MR was present in 24% and 68% of patients, respectively, with a mixed etiology observed in 8%.

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

MR grade ≤ 1 was observed in 39 of 50 (78%) patients at discharge and in 36 of 46 (78%) 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, improvement in NYHA class was reported in 73% of patients. The 6-minute walk test distance increased by 73±12 m in patients without relevant tricuspid regurgitation.

In this real-world population study, the Pascal device effectively reduced MR and lead to functional improvements on short-term follow-up, concluded the investigators in EuroIntervention.

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