Philipp Lurz MD, PhD , Karl-Patrik Kresoja MD , Christian Besler MD , Stefan Verheye MD , Paul Vermeersch MD , Volker Rudolph MD , Kai Friedrichs MD , Omar Abdul-Jawad Altisent MD , Xavier Freixa MD , Laura Sanchis MD , Ignacio Cruz-Gonzalez MD , Pablo Antunez-Muiños MD , Jozef Bartunek MD , Marc Vanderheyden MD , Mohammad Sherif MD , Tobias Daniel Trippel MD , Rodrigo Estevez-Loureiro MD , Manuel Barreiro-Perez MD , Hana Vaknin Assa MD , Ran Kornowski MD
{"title":"异位经导管三尖瓣置换术治疗三尖瓣反流","authors":"Philipp Lurz MD, PhD , Karl-Patrik Kresoja MD , Christian Besler MD , Stefan Verheye MD , Paul Vermeersch MD , Volker Rudolph MD , Kai Friedrichs MD , Omar Abdul-Jawad Altisent MD , Xavier Freixa MD , Laura Sanchis MD , Ignacio Cruz-Gonzalez MD , Pablo Antunez-Muiños MD , Jozef Bartunek MD , Marc Vanderheyden MD , Mohammad Sherif MD , Tobias Daniel Trippel MD , Rodrigo Estevez-Loureiro MD , Manuel Barreiro-Perez MD , Hana Vaknin Assa MD , Ran Kornowski MD","doi":"10.1016/j.jcin.2025.04.036","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Transcatheter tricuspid interventions are an emerging therapy for patients with severe tricuspid regurgitation (TR), but a significant proportion of patients with TR are unsuitable for orthotopic tricuspid valve (TV) approaches.</div></div><div><h3>Objectives</h3><div>The aim of this study was to investigate the performance of a dedicated heterotopic valve replacement system in patients with severe or greater TR.</div></div><div><h3>Methods</h3><div>This single-arm, multicenter study assessed the technical performance, efficacy, and safety of heterotopic cross-caval transcatheter TV replacement using the Trillium device at 30 days. Patients with severe or greater TR ineligible for surgical or other interventional orthotopic TV treatment were included.</div></div><div><h3>Results</h3><div>Between 2021 and 2023, 20 patients (median age 81 years, 40% women) were included. Device implantation was successful in all cases, and no intraprocedural deaths or conversions to surgery occurred. Postprocedurally, central venous pressure was reduced (median −3 mm Hg; Q1-Q3: −5 to −1 mm Hg; <em>P</em> = 0.003), and TR severity as assessed at the level of the Trillium device was reduced in all cases (<em>P</em> < 0.001). Within the 30-day follow-up period, 1 patient died, 2 patients experienced heart failure hospitalization, 2 required hemodialysis, and 2 experienced major bleeding. There was an improvement in NYHA functional class (<em>P</em> = 0.005) and a trend toward a reduction in edema severity score (median −0.5; Q1-Q3: −1 to −0; <em>P</em> = 0.052).</div></div><div><h3>Conclusions</h3><div>The Trillium device is a safe and effective device for the treatment of patients with severe or greater TR ineligible for other therapeutic options. The device leads to a hemodynamic and symptomatic improvement of the burden of TR, whether this translates into favorable outcomes is to be proven in randomized trials.</div></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"18 11","pages":"Pages 1425-1434"},"PeriodicalIF":11.7000,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Heterotopic Crosscaval Transcatheter Tricuspid Valve Replacement for Patients With Tricuspid Regurgitation\",\"authors\":\"Philipp Lurz MD, PhD , Karl-Patrik Kresoja MD , Christian Besler MD , Stefan Verheye MD , Paul Vermeersch MD , Volker Rudolph MD , Kai Friedrichs MD , Omar Abdul-Jawad Altisent MD , Xavier Freixa MD , Laura Sanchis MD , Ignacio Cruz-Gonzalez MD , Pablo Antunez-Muiños MD , Jozef Bartunek MD , Marc Vanderheyden MD , Mohammad Sherif MD , Tobias Daniel Trippel MD , Rodrigo Estevez-Loureiro MD , Manuel Barreiro-Perez MD , Hana Vaknin Assa MD , Ran Kornowski MD\",\"doi\":\"10.1016/j.jcin.2025.04.036\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>Transcatheter tricuspid interventions are an emerging therapy for patients with severe tricuspid regurgitation (TR), but a significant proportion of patients with TR are unsuitable for orthotopic tricuspid valve (TV) approaches.</div></div><div><h3>Objectives</h3><div>The aim of this study was to investigate the performance of a dedicated heterotopic valve replacement system in patients with severe or greater TR.</div></div><div><h3>Methods</h3><div>This single-arm, multicenter study assessed the technical performance, efficacy, and safety of heterotopic cross-caval transcatheter TV replacement using the Trillium device at 30 days. Patients with severe or greater TR ineligible for surgical or other interventional orthotopic TV treatment were included.</div></div><div><h3>Results</h3><div>Between 2021 and 2023, 20 patients (median age 81 years, 40% women) were included. Device implantation was successful in all cases, and no intraprocedural deaths or conversions to surgery occurred. Postprocedurally, central venous pressure was reduced (median −3 mm Hg; Q1-Q3: −5 to −1 mm Hg; <em>P</em> = 0.003), and TR severity as assessed at the level of the Trillium device was reduced in all cases (<em>P</em> < 0.001). Within the 30-day follow-up period, 1 patient died, 2 patients experienced heart failure hospitalization, 2 required hemodialysis, and 2 experienced major bleeding. There was an improvement in NYHA functional class (<em>P</em> = 0.005) and a trend toward a reduction in edema severity score (median −0.5; Q1-Q3: −1 to −0; <em>P</em> = 0.052).</div></div><div><h3>Conclusions</h3><div>The Trillium device is a safe and effective device for the treatment of patients with severe or greater TR ineligible for other therapeutic options. The device leads to a hemodynamic and symptomatic improvement of the burden of TR, whether this translates into favorable outcomes is to be proven in randomized trials.</div></div>\",\"PeriodicalId\":14688,\"journal\":{\"name\":\"JACC. Cardiovascular interventions\",\"volume\":\"18 11\",\"pages\":\"Pages 1425-1434\"},\"PeriodicalIF\":11.7000,\"publicationDate\":\"2025-06-09\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"JACC. 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Heterotopic Crosscaval Transcatheter Tricuspid Valve Replacement for Patients With Tricuspid Regurgitation
Background
Transcatheter tricuspid interventions are an emerging therapy for patients with severe tricuspid regurgitation (TR), but a significant proportion of patients with TR are unsuitable for orthotopic tricuspid valve (TV) approaches.
Objectives
The aim of this study was to investigate the performance of a dedicated heterotopic valve replacement system in patients with severe or greater TR.
Methods
This single-arm, multicenter study assessed the technical performance, efficacy, and safety of heterotopic cross-caval transcatheter TV replacement using the Trillium device at 30 days. Patients with severe or greater TR ineligible for surgical or other interventional orthotopic TV treatment were included.
Results
Between 2021 and 2023, 20 patients (median age 81 years, 40% women) were included. Device implantation was successful in all cases, and no intraprocedural deaths or conversions to surgery occurred. Postprocedurally, central venous pressure was reduced (median −3 mm Hg; Q1-Q3: −5 to −1 mm Hg; P = 0.003), and TR severity as assessed at the level of the Trillium device was reduced in all cases (P < 0.001). Within the 30-day follow-up period, 1 patient died, 2 patients experienced heart failure hospitalization, 2 required hemodialysis, and 2 experienced major bleeding. There was an improvement in NYHA functional class (P = 0.005) and a trend toward a reduction in edema severity score (median −0.5; Q1-Q3: −1 to −0; P = 0.052).
Conclusions
The Trillium device is a safe and effective device for the treatment of patients with severe or greater TR ineligible for other therapeutic options. The device leads to a hemodynamic and symptomatic improvement of the burden of TR, whether this translates into favorable outcomes is to be proven in randomized trials.
期刊介绍:
JACC: Cardiovascular Interventions is a specialist journal launched by the Journal of the American College of Cardiology (JACC). It covers the entire field of interventional cardiovascular medicine, including cardiac, peripheral, and cerebrovascular interventions. The journal publishes studies that will impact the practice of interventional cardiovascular medicine, including clinical trials, experimental studies, and in-depth discussions by respected experts. To enhance visual understanding, the journal is published both in print and electronically, utilizing the latest technologies.