TY - JOUR
T1 - 12-Month outcomes of transcatheter tricuspid valve repair with the PASCAL system for severe tricuspid regurgitation
AU - Kitamura, Mitsunobu
AU - Fam, Neil P.
AU - Braun, Daniel
AU - Ruf, Tobias
AU - Sugiura, Atsushi
AU - Narang, Akhil
AU - Connelly, Kim A.
AU - Ho, Edwin
AU - Nabauer, Michael
AU - Hausleiter, Jörg
AU - Weber, Marcel
AU - Nickenig, Georg
AU - Davidson, Charles J.
AU - Thiele, Holger
AU - von Bardeleben, Ralph Stephan
AU - Lurz, Philipp
N1 - Publisher Copyright:
© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.
PY - 2021/5/1
Y1 - 2021/5/1
N2 - 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.
AB - 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.
KW - 12-month outcomes
KW - PASCAL
KW - right-sided heart failure
KW - severe tricuspid regurgitation
KW - transcatheter tricuspid valve intervention
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U2 - 10.1002/ccd.29583
DO - 10.1002/ccd.29583
M3 - Article
C2 - 33660364
AN - SCOPUS:85101900582
SN - 1522-1946
VL - 97
SP - 1281
EP - 1289
JO - Catheterization and Cardiovascular Interventions
JF - Catheterization and Cardiovascular Interventions
IS - 6
ER -