TY - JOUR
T1 - Compassionate Use of the PASCAL Transcatheter Valve Repair System for Severe Tricuspid Regurgitation
T2 - A Multicenter, Observational, First-in-Human Experience
AU - Fam, Neil P.
AU - Braun, Daniel
AU - von Bardeleben, Ralph Stephan
AU - Nabauer, Michael
AU - Ruf, Tobias
AU - Connelly, Kim A.
AU - Ho, Edwin
AU - Thiele, Holger
AU - Lurz, Philipp
AU - Weber, Marcel
AU - Nickenig, Georg
AU - Narang, Akhil
AU - Davidson, Charles J.
AU - Hausleiter, Jörg
N1 - Publisher Copyright:
© 2019 American College of Cardiology Foundation
PY - 2019/12/23
Y1 - 2019/12/23
N2 - Objectives: The purpose of this observational first-in-human experience was to investigate the feasibility and safety of the PASCAL transcatheter valve repair system and its impact on short-term clinical outcomes in patients with severe tricuspid regurgitation (TR). Background: Transcatheter repair of severe TR is a promising treatment option for patients at prohibitive surgical risk. Large leaflet coaptation gaps and tethering represent common features that challenge the application of transcatheter repair techniques. Methods: Twenty-eight patients with severe TR were treated with the PASCAL system in a compassionate use experience at 6 sites. All patients had heart failure due to severe TR and were deemed at high surgical risk by institutional heart teams. The primary outcome was procedural success, defined as the implantation of at least 1 device with post-procedural TR grade ≤2+, without mortality or conversion to surgery. Results: All patients (mean age 78 ± 6 years, 54% women) were at high surgical risk (mean European System for Cardiac Operative Risk Evaluation II score 6.2 ± 5.2%). TR etiology was functional in 92%, with mean tricuspid annular diameter of 49.5 ± 6 mm and mean coaptation gap of 6.9 ± 3 mm. Procedural success was 86%, with 1.4 ± 0.6 devices implanted per patient. There were no intraprocedural complications. At 30-day follow-up, mortality was 7.1%, 88% of patients were in New York Heart Association functional class I or II, with TR grade ≤2+ in 85%. There were 2 single-leaflet device attachments, which were managed conservatively. Six-min walk distance improved from 240 m (interquartile range: 172 to 337 m) to 335 m (interquartile range: 251 to 385 m) (p < 0.001). Conclusions: This first-in-human experience evaluating transcatheter tricuspid repair with the PASCAL system demonstrated high procedural success, acceptable safety, and significant clinical improvement. Larger prospective studies with long-term follow-up are needed to confirm these initial promising results and further define the impact of PASCAL tricuspid repair on clinical outcomes.
AB - Objectives: The purpose of this observational first-in-human experience was to investigate the feasibility and safety of the PASCAL transcatheter valve repair system and its impact on short-term clinical outcomes in patients with severe tricuspid regurgitation (TR). Background: Transcatheter repair of severe TR is a promising treatment option for patients at prohibitive surgical risk. Large leaflet coaptation gaps and tethering represent common features that challenge the application of transcatheter repair techniques. Methods: Twenty-eight patients with severe TR were treated with the PASCAL system in a compassionate use experience at 6 sites. All patients had heart failure due to severe TR and were deemed at high surgical risk by institutional heart teams. The primary outcome was procedural success, defined as the implantation of at least 1 device with post-procedural TR grade ≤2+, without mortality or conversion to surgery. Results: All patients (mean age 78 ± 6 years, 54% women) were at high surgical risk (mean European System for Cardiac Operative Risk Evaluation II score 6.2 ± 5.2%). TR etiology was functional in 92%, with mean tricuspid annular diameter of 49.5 ± 6 mm and mean coaptation gap of 6.9 ± 3 mm. Procedural success was 86%, with 1.4 ± 0.6 devices implanted per patient. There were no intraprocedural complications. At 30-day follow-up, mortality was 7.1%, 88% of patients were in New York Heart Association functional class I or II, with TR grade ≤2+ in 85%. There were 2 single-leaflet device attachments, which were managed conservatively. Six-min walk distance improved from 240 m (interquartile range: 172 to 337 m) to 335 m (interquartile range: 251 to 385 m) (p < 0.001). Conclusions: This first-in-human experience evaluating transcatheter tricuspid repair with the PASCAL system demonstrated high procedural success, acceptable safety, and significant clinical improvement. Larger prospective studies with long-term follow-up are needed to confirm these initial promising results and further define the impact of PASCAL tricuspid repair on clinical outcomes.
KW - PASCAL
KW - transcatheter tricuspid valve repair
KW - tricuspid regurgitation
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U2 - 10.1016/j.jcin.2019.09.046
DO - 10.1016/j.jcin.2019.09.046
M3 - Article
C2 - 31857018
AN - SCOPUS:85076030297
SN - 1936-8798
VL - 12
SP - 2488
EP - 2495
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 24
ER -