December 15, 2019
Outcomes Reported From Compassionate Use Experience With Edwards' Pascal Transcatheter Valve Repair System for Severe Tricuspid Regurgitation
December 16, 2019—Findings from an investigation of the feasibility and safety of the Pascal transcatheter valve repair system (Edwards Lifesciences) for severe tricuspid regurgitation (TR) in a multicenter, observational, first-in-human experience were published by Neil P. Fam, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2019;12:2488–2495).
According to the investigators, the background of the study is that transcatheter repair of severe TR is a promising treatment option for patients at prohibitive surgical risk; however, large leaflet coaptation gaps and tethering represent common features that challenge the application of transcatheter repair techniques.
As summarized in JACC: Cardiovascular Interventions, the study was composed of 28 patients with severe TR who were treated with the Pascal system in a compassionate use experience at six sites. All patients had heart failure caused by 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 one device with postprocedural TR grade ≤ 2+, without mortality or conversion to surgery.
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 a mean tricuspid annular diameter of 49.5 ± 6 mm and a mean coaptation gap of 6.9 ± 3 mm.
The investigators reported the following:
- 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%, and 88% of patients were in New York Heart Association functional class I or II, with TR grade ≤ 2+ in 85%.
- There were two single-leaflet device attachments, which were managed conservatively.
- Six-minute walk distance improved from 240 meters (interquartile range, 172 to 337 meters) to 335 meters (interquartile range, 251 to 385 meters) (P < .001).
In JACC: Cardiovascular Interventions, the investigators concluded that this first-in-human experience evaluating transcatheter tricuspid repair with the Pascal system demonstrated high procedural success, acceptable safety, and significant clinical improvement. They noted that 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.