Lluis Asmarats1, Gidon Perlman2, Fabien Praz3, Mark Hensey4, Michael P Chrissoheris5, Francois Philippon1, Hadass Ofek4, Jian Ye4, Rishi Puri6, Philippe Pibarot1, Adrian Attinger4, Robert Moss4, Elisabeth Bédard1, Aris Moschovitis3, David Reineke3, Sandra Lauck4, Philipp Blanke4, Jonathon Leipsic4, Konstantinos Spargias5, Stephan Windecker3, John G Webb4, Josep Rodés-Cabau7. 1. Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Canada. 2. Department of Cardiology, St. Paul's Hospital, Vancouver, Canada; Department of Cardiology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel. 3. Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland. 4. Department of Cardiology, St. Paul's Hospital, Vancouver, Canada. 5. Department of Cardiology, Hygeia Hospital, Athens, Greece. 6. Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Canada; Department of Medicine, University of Adelaide, Adelaide, Australia; Department of Cardiology, Cleveland Clinic Coordinating Center for Clinical Research, Cleveland, Ohio. 7. Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Canada. Electronic address: josep.rodes@criucpq.ulaval.ca.
Abstract
OBJECTIVES: To evaluate the long-term (≥2 years) outcomes following transcatheter tricuspid valve repair (TTVr) with the FORMA Transcatheter Tricuspid Valve Repair System (Edwards Lifesciences, Irvine, California). BACKGROUND: Scarce data exist on long-term outcomes following TTVr. METHODS: This multicenter experience included patients with severe tricuspid regurgitation (TR) who underwent TTVr with the FORMA system at 4 centers under a compassionate clinical use program. Data were collected at baseline, 30 days, and 1 year, and yearly thereafter. RESULTS: Nineteen patients (76 ± 9 years of age, 74% women, mean EuroSCORE II [European System for Cardiac Operative Risk Evaluation] 9.2 ± 5.6%) with functional TR were included. Procedural success was achieved in 17 (89%) patients and there were no cases of 30-day mortality. At a median follow-up of 32 (interquartile range: 24 to 36) months, 4 (24%) patients had died (3 from terminal heart failure, 1 from sepsis) and 3 (18%) patients required rehospitalization for heart failure. There was 1 device-related thrombosis and 1 pulmonary embolism, both in the setting of subtherapeutic oral anticoagulation. Less than severe TR was observed at echocardiography in 67% of patients at the 2- to 3-year follow-up. Among 15 successfully implanted patients with at least 24-month follow-up, significant improvements in New York Heart Association functional class (p < 0.001), 6-min walk test (+54 m; p = 0.016) and Kansas City Cardiomyopathy Questionnaire score (+16 points; p = 0.016) were observed, compared with baseline. CONCLUSIONS: TTVr using the FORMA system showed favorable long-term safety profile in high-surgical-risk patients, with sustained functional improvement and acceptable TR reduction up to 3 years.
OBJECTIVES: To evaluate the long-term (≥2 years) outcomes following transcatheter tricuspid valve repair (TTVr) with the FORMA Transcatheter Tricuspid Valve Repair System (Edwards Lifesciences, Irvine, California). BACKGROUND: Scarce data exist on long-term outcomes following TTVr. METHODS: This multicenter experience included patients with severe tricuspid regurgitation (TR) who underwent TTVr with the FORMA system at 4 centers under a compassionate clinical use program. Data were collected at baseline, 30 days, and 1 year, and yearly thereafter. RESULTS: Nineteen patients (76 ± 9 years of age, 74% women, mean EuroSCORE II [European System for Cardiac Operative Risk Evaluation] 9.2 ± 5.6%) with functional TR were included. Procedural success was achieved in 17 (89%) patients and there were no cases of 30-day mortality. At a median follow-up of 32 (interquartile range: 24 to 36) months, 4 (24%) patients had died (3 from terminal heart failure, 1 from sepsis) and 3 (18%) patients required rehospitalization for heart failure. There was 1 device-related thrombosis and 1 pulmonary embolism, both in the setting of subtherapeutic oral anticoagulation. Less than severe TR was observed at echocardiography in 67% of patients at the 2- to 3-year follow-up. Among 15 successfully implanted patients with at least 24-month follow-up, significant improvements in New York Heart Association functional class (p < 0.001), 6-min walk test (+54 m; p = 0.016) and Kansas City Cardiomyopathy Questionnaire score (+16 points; p = 0.016) were observed, compared with baseline. CONCLUSIONS: TTVr using the FORMA system showed favorable long-term safety profile in high-surgical-risk patients, with sustained functional improvement and acceptable TR reduction up to 3 years.
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