Neil P Fam1, Daniel Braun2, Ralph Stephan von Bardeleben3, Michael Nabauer2, Tobias Ruf3, Kim A Connelly1, Edwin Ho1, Holger Thiele4, Philipp Lurz4, Marcel Weber5, Georg Nickenig5, Akhil Narang6, Charles J Davidson6, Jörg Hausleiter7. 1. St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada. 2. Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Munich, Germany. 3. Zentrum für Kardiologie, Universitätsmedizin Mainz, Johannes Gutenberg Universität Mainz, Mainz, Germany. 4. Department of Internal Medicine/Cardiology, Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany. 5. Medizinische Klinik II, Herzzentrum Bonn, Bonn, Germany. 6. Bluhm Cardiovascular Institute, Northwestern University, Chicago, Illinois. 7. Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Munich, Germany. Electronic address: joerg.hausleiter@med.uni-muenchen.de.
Abstract
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.
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.
Authors: Peng-Ming Yu; Yu-Qiang Wang; Ze-Ruxing Luo; Raymond C C Tsang; Oystein Tronstad; Jun Shi; Ying-Qiang Guo; Alice Y M Jones Journal: Front Cardiovasc Med Date: 2022-05-19
Authors: Atsushi Sugiura; Johanna Vogelhuber; Can Öztürk; Zita Schwaibold; David Reckers; Tadahiro Goto; Refik Kavsur; Marc Ulrich Becher; Sebastian Zimmer; Georg Nickenig; Marcel Weber Journal: Clin Res Cardiol Date: 2020-12-12 Impact factor: 5.460
Authors: Antonio Mangieri; Matteo Pagnesi; Damiano Regazzoli; Alessandra Laricchia; Edwin Ho; Ythan Goldberg; Mei Chau; Francesco Gallo; Andrea Fisicaro; Arif Khokhar; Antonio Colombo; Francesco Giannini; Azeem Latib Journal: Front Cardiovasc Med Date: 2020-10-14