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Kitamura, Mitsunobu; Fam, Neil P.; Braun, Daniel; Ruf, Tobias; Sugiura, Atsushi; Narang, Akhil; Connelly, Kim A.; Ho, Edwin; Nabauer, Michael; Hausleiter, Jörg; Weber, Marcel; Nickenig, Georg; Davidson, Charles J.; Thiele, Holger; Bardeleben, Ralph Stephan von and Lurz, Philipp (2021): 12-Month outcomes of transcatheter tricuspid valve repair with the PASCAL system for severe tricuspid regurgitation. In: Catheterization and Cardiovascular Interventions, Vol. 97, No. 6: pp. 1281-1289

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Objectives We investigated the durability of tricuspid regurgitation (TR) reduction and the clinical outcomes through 12 months after transcatheter tricuspid valve repair (TTVr) with the PASCAL Transcatheter Valve Repair System. Background TTVr has rapidly developed and demonstrated favorable acute outcomes, but longer follow-up data are needed. Methods Overall, 30 patients (age 77 +/- 6 years;57% female) received PASCAL implantation from September 2017 to May 2019 and completed a clinical follow-up at 12 months. Results The TR etiology was functional in 25 patients (83%), degenerative in three (10%), and mixed in two (7%). All patients had TR severe or greater (massive or torrential in 80%) and heart failure symptoms (90% in NYHA III or IV) under optimal medical treatment. Single-leaflet device attachment occurred in two patients. Moderate or less TR was achieved in 23/28 patients (82%) at 30 days, which was sustained at 12 months (86%). Two patients underwent repeat TTVr due to residual torrential TR (day 173) and recurrence of severe TR (day 280), respectively. One-year survival rate was 93%;6 patients required rehospitalization due to acute heart failure. NYHA functional class I or II was achieved in 90% and 6-minute walk distance improved from 275 +/- 122 m at baseline to 347 +/- 112 m at 12-month (+72 +/- 82 m, p < .01). There was no stroke, endocarditis, or device embolization during the follow-up. Conclusions Twelve-month outcomes from this multicenter compassionate use experience with the PASCAL System demonstrated high procedural success, acceptable safety, and significant clinical improvement.

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