Transcatheter edge-to-edge mitral valve repair with the PASCAL System: early results from a real-world series.

AIMS This study sought to characterize the real-world performance and clinical outcomes of the PASCAL system, a leaflet approximation device for transcatheter mitral valve repair. METHODS AND RESULTS Fifty patients in NYHA class II-IV despite optimal medical therapy (median age 78.0 [IQR 74.5-81.0], 52% female, logEuroscore 21.6 [IQR 13.2-30.2]) were treated for severe mitral regurgitation (MR) and followed up for one month. Primary and secondary MR was present in 24% and 68% of patients, respectively, with a mixed aetiology observed in 8%. A 1-device-strategy was employed in 26/50 patients (52%), a 2-device-strategy in 23/50 (46%) patients and a 3-device-strategy in 1/50 (2%) patient. Technical and procedural success was achieved in 100% and 98% of patients, respectively. MR grade ≤1 was observed in 39/50 (78%) patients at discharge and in 36/46 (78%) patients at one month, with transvalvular gradients remaining ≤5 mmHg in all patients. One device embolization and one single leaflet device attachment was observed during follow-up. After one month, 73% of patients reported an improvement in NYHA class and 6-minute-walk-test distance increased by 73±12m in patients without relevant tricuspid regurgitation. CONCLUSIONS In a real-world population, the PASCAL device effectively reduces MR and leads to functional improvements on short-term follow-up.