Giulio Russo, Daniela Pedicino, Marianna Adamo, Hannes Alessandrini, Martin Andreas, Daniel Braun, Kim A. Connelly, Gaetano Chiricolo, Paolo Denti, Rodrigo Estevez-Loureiro, Neil Fam, Rebecca T. Hahn, Claudia Harr, Joerg Hausleiter, Dominique Himbert, Daniel Kalbacher, Edwin Ho, Azeem Latib, Edith Lubos, Sebastian Ludwig, Gianluca Massaro, Philipp Lurz, Marco Metra, Vanessa Monivas, Georg Nickenig, Giovanni Pedrazzini, Alberto Pozzoli, Fabien Praz, Joseph Rodes-Cabau, Christian Besler, Karl-Philipp Rommel, Joachim Schofer, Andrea Scotti, Kerstin Piayda, Giuseppe Massimo Sangiorgi, Horst Sievert, Gilbert H. L. Tang, Isaac Pascual, Holger Thiele, Florian Schlotter, Andrea Natale, Ralph Stephan von Bardeleben, John Webb, Stephan Windecker, Martin Leon, Maurice Enriquez-Sarano, Francesco Maisano, Stefan Bloechlinger, Maurizio Taramasso
{"title":"Outcomes Stratified by Adapted Inclusion Criteria After Transcatheter Tricuspid Edge-to-Edge Repair","authors":"Giulio Russo, Daniela Pedicino, Marianna Adamo, Hannes Alessandrini, Martin Andreas, Daniel Braun, Kim A. Connelly, Gaetano Chiricolo, Paolo Denti, Rodrigo Estevez-Loureiro, Neil Fam, Rebecca T. Hahn, Claudia Harr, Joerg Hausleiter, Dominique Himbert, Daniel Kalbacher, Edwin Ho, Azeem Latib, Edith Lubos, Sebastian Ludwig, Gianluca Massaro, Philipp Lurz, Marco Metra, Vanessa Monivas, Georg Nickenig, Giovanni Pedrazzini, Alberto Pozzoli, Fabien Praz, Joseph Rodes-Cabau, Christian Besler, Karl-Philipp Rommel, Joachim Schofer, Andrea Scotti, Kerstin Piayda, Giuseppe Massimo Sangiorgi, Horst Sievert, Gilbert H. L. Tang, Isaac Pascual, Holger Thiele, Florian Schlotter, Andrea Natale, Ralph Stephan von Bardeleben, John Webb, Stephan Windecker, Martin Leon, Maurice Enriquez-Sarano, Francesco Maisano, Stefan Bloechlinger, Maurizio Taramasso","doi":"10.1002/ccd.70763","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>Recent trials demonstrated that tricuspid transcatheter edge-to-edge repair (T-TEER) is particularly effective for symptoms and quality of life improvement. However, its effect on prognosis is still unclear. Moreover, the applicability of trials inclusion/exclusion criteria has not been investigated.</p>\n </section>\n \n <section>\n \n <h3> Aims</h3>\n \n <p>The aim of the present study is to investigate the applicability of TRILUMINATE and Tri.Fr trials inclusion and exclusion criteria on real-world patients from TRIVALVE registry, and to evaluate their effects on outcomes.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>Patients undergoing T-TEER were selected from the TRIVALVE registry and, according to inclusion and exclusion criteria, divided in four groups: TRILUMINATE eligible versus ineligible and Tri.Fr eligible versus ineligible patients. TRILUMINATE and Tri.Fr analysis were conducted separately.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>From a total of 664 patients of the TRIVALVE registry, 520 and 519 were included in the TRILUMINATE and Tri.Fr analysis, respectively. In particular, 240 patients (46%) met the TRILUMINATE criteria and 260 (50%) those of Tri.Fr. Baseline characteristics were significantly different between trials' eligible and ineligible patients. TRILUMINATE-eligible patients showed significant lower mortality/rehospitalization compared to ineligible ones (12% vs. 25%, <i>p</i> = 0.028), as well as Tri.Fr-eligible versus ineligible ones (15% vs. 22%, <i>p</i> = 0.007).</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>In patients with TR undergoing T-TEER, inclusion and exclusion criteria of TRILUMINATE and Tri.Fr are applicable to around half of real-world patients. Patients matching trials criteria have lower mortality/rehospitalization.</p>\n </section>\n </div>","PeriodicalId":9650,"journal":{"name":"Catheterization and Cardiovascular Interventions","volume":"108 4","pages":"1198-1205"},"PeriodicalIF":1.9000,"publicationDate":"2026-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Catheterization and Cardiovascular Interventions","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/ccd.70763","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2026/7/21 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
Abstract
Background
Recent trials demonstrated that tricuspid transcatheter edge-to-edge repair (T-TEER) is particularly effective for symptoms and quality of life improvement. However, its effect on prognosis is still unclear. Moreover, the applicability of trials inclusion/exclusion criteria has not been investigated.
Aims
The aim of the present study is to investigate the applicability of TRILUMINATE and Tri.Fr trials inclusion and exclusion criteria on real-world patients from TRIVALVE registry, and to evaluate their effects on outcomes.
Methods
Patients undergoing T-TEER were selected from the TRIVALVE registry and, according to inclusion and exclusion criteria, divided in four groups: TRILUMINATE eligible versus ineligible and Tri.Fr eligible versus ineligible patients. TRILUMINATE and Tri.Fr analysis were conducted separately.
Results
From a total of 664 patients of the TRIVALVE registry, 520 and 519 were included in the TRILUMINATE and Tri.Fr analysis, respectively. In particular, 240 patients (46%) met the TRILUMINATE criteria and 260 (50%) those of Tri.Fr. Baseline characteristics were significantly different between trials' eligible and ineligible patients. TRILUMINATE-eligible patients showed significant lower mortality/rehospitalization compared to ineligible ones (12% vs. 25%, p = 0.028), as well as Tri.Fr-eligible versus ineligible ones (15% vs. 22%, p = 0.007).
Conclusions
In patients with TR undergoing T-TEER, inclusion and exclusion criteria of TRILUMINATE and Tri.Fr are applicable to around half of real-world patients. Patients matching trials criteria have lower mortality/rehospitalization.
背景：最近的试验表明，三尖瓣经导管边缘到边缘修复（T-TEER）对症状和生活质量的改善特别有效。然而，其对预后的影响尚不清楚。此外，尚未对试验纳入/排除标准的适用性进行调查。目的：探讨三聚氰胺酸酯和三聚氰胺酸酯的适用性。针对TRIVALVE注册表中真实患者的试验纳入和排除标准，并评估其对结果的影响。方法：从TRIVALVE注册表中选择接受T-TEER的患者，根据纳入和排除标准分为四组：TRILUMINATE合格组、不合格组和Tri组。对于符合条件的患者和不符合条件的患者。三聚氰胺和三。分别进行Fr分析。结果：在TRIVALVE注册的664例患者中，520例和519例分别纳入了TRILUMINATE和Tri。分别进行分析。特别是，240例（46%）患者符合TRILUMINATE标准，260例（50%）符合Tri.Fr标准。基线特征在符合试验条件和不符合试验条件的患者之间有显著差异。与不符合条件的患者相比，符合triluminate条件的患者死亡率/再住院率显著降低（12%对25%，p = 0.028）。符合条件的患者与不符合条件的患者（15% vs 22%, p = 0.007）。结论：在接受T-TEER治疗的TR患者中，Tri和Tri的纳入和排除标准。Fr适用于现实世界中大约一半的患者。符合试验标准的患者死亡率/再住院率较低。
期刊介绍：
Catheterization and Cardiovascular Interventions is an international journal covering the broad field of cardiovascular diseases. Subject material includes basic and clinical information that is derived from or related to invasive and interventional coronary or peripheral vascular techniques. The journal focuses on material that will be of immediate practical value to physicians providing patient care in the clinical laboratory setting. To accomplish this, the journal publishes Preliminary Reports and Work In Progress articles that complement the traditional Original Studies, Case Reports, and Comprehensive Reviews. Perspective and insight concerning controversial subjects and evolving technologies are provided regularly through Editorial Commentaries furnished by members of the Editorial Board and other experts. Articles are subject to double-blind peer review and complete editorial evaluation prior to any decision regarding acceptability.
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