Author + information
- Received July 17, 2019
- Revision received September 16, 2019
- Accepted September 24, 2019
- Published online December 16, 2019.
- Neil P. Fam, MD, MSca,∗,
- Daniel Braun, MDb,∗,
- Ralph Stephan von Bardeleben, MDc,∗,
- Michael Nabauer, MDb,
- Tobias Ruf, MDc,
- Kim A. Connelly, MD, PhDa,
- Edwin Ho, MDa,
- Holger Thiele, MDd,
- Philipp Lurz, MDd,
- Marcel Weber, MDe,
- Georg Nickenig, MDe,
- Akhil Narang, MDf,
- Charles J. Davidson, MDf and
- Jörg Hausleiter, MDb,∗ ()
- aSt. Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada
- bMedizinische Klinik und Poliklinik I, Klinikum der Universität München, Munich, Germany
- cZentrum für Kardiologie, Universitätsmedizin Mainz, Johannes Gutenberg Universität Mainz, Mainz, Germany
- dDepartment of Internal Medicine/Cardiology, Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany
- eMedizinische Klinik II, Herzzentrum Bonn, Bonn, Germany
- fBluhm Cardiovascular Institute, Northwestern University, Chicago, Illinois
- ↵∗Address for correspondence:
Prof. Dr. med. Jörg Hausleiter, Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Marchioninistrasse 15, D-81377 München, Germany.
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.
↵∗ Drs. Fam, Braun, and von Bardeleben are joint first authors and contributed equally to this paper.
Dr. Fam has received speaking honoraria from Abbott Vascular; and is a consultant for Edwards Lifesciences. Dr. Connelly has received speaking honoraria from Abbott Vascular. Drs. Braun and Nabauer have received speaking honoraria from Abbott Vascular. Dr. von Bardeleben has received speaking honoraria from Abbott Vascular and Edwards Lifesciences. Dr. Hausleiter has received speaking honoraria and research support from Abbott Vascular and Edwards Lifesciences; and is a consultant for Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received July 17, 2019.
- Revision received September 16, 2019.
- Accepted September 24, 2019.
- 2019 American College of Cardiology Foundation
This article requires a subscription or purchase to view the full text. If you are a subscriber or member, click Login or the Subscribe link (top menu above) to access this article.