Myriam Carpenito, Valeria Maria De Luca, Valeria Cammalleri, Mariagrazia Piscione, Giorgio Antonelli, Dario Gaudio, Alessandro Strumia, Anna Laura Di Pumpo, Simona Mega, Massimiliano Carassiti, Francesco Grigioni, Gian Palo Ussia
{"title":"Edge-to-edge repair for tricuspid regurgitation: 1-year follow-up and clinical implications from the TR-Interventional Study.","authors":"Myriam Carpenito, Valeria Maria De Luca, Valeria Cammalleri, Mariagrazia Piscione, Giorgio Antonelli, Dario Gaudio, Alessandro Strumia, Anna Laura Di Pumpo, Simona Mega, Massimiliano Carassiti, Francesco Grigioni, Gian Palo Ussia","doi":"10.2459/JCM.0000000000001685","DOIUrl":null,"url":null,"abstract":"<p><strong>Aims: </strong>Tricuspid regurgitation affects 7% of the population, with moderate-to-severe tricuspid regurgitation contributing to up to 12% of heart failure-related hospitalizations. Traditional treatments have several limitations, prompting the exploration of innovative interventions. Our study aims to investigate the efficacy and clinical outcomes following transcatheter edge-to-edge repair (TEER) in patients with severe, symptomatic tricuspid regurgitation through a 1-year follow-up.</p><p><strong>Methods: </strong>The TR-Interventional study (TRIS) is a prospective, single-arm study conducted at the Fondazione Policlinico Universitario Campus Bio-Medico. From March 2021 to December 2023, we enrolled 44 symptomatic patients with at least severe tricuspid regurgitation referred for tricuspid TEER with the TriClip System.</p><p><strong>Results: </strong>The study cohort had a mean age of 78.3 ± 7 years with a median TRISCORE 5.4% (interquartile range 3.5-9.0). Significant reduction in tricuspid regurgitation grade occurred immediately after the procedure with durable results at 30 days and 1-year follow-up (P < 0.001). The primary efficacy endpoint, which assesses the successful implantation and performance of the device at 30 days, was attained in 82.9% of patients. The secondary efficacy endpoint, evaluating the stability of tricuspid regurgitation reduction at 12 months, was achieved in 82.3% of patients. The NYHA Functional Class and KCCQ scores significantly improved from baseline to 1 year (P < 0.05; P < 0.0001). Echocardiographic assessments reveal sustained positive right ventricle remodeling throughout the 1-year follow-up period.</p><p><strong>Conclusion: </strong>Evidence from the TRIS study confirms that tricuspid TEER is a valuable and effective therapeutic option in contemporary practice. The lasting reduction in tricuspid regurgitation at 1 year is associated with sustained clinical benefits and reverse structural remodeling of the right ventricle.</p>","PeriodicalId":15228,"journal":{"name":"Journal of Cardiovascular Medicine","volume":" ","pages":""},"PeriodicalIF":2.9000,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Cardiovascular Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2459/JCM.0000000000001685","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
Abstract
Aims: Tricuspid regurgitation affects 7% of the population, with moderate-to-severe tricuspid regurgitation contributing to up to 12% of heart failure-related hospitalizations. Traditional treatments have several limitations, prompting the exploration of innovative interventions. Our study aims to investigate the efficacy and clinical outcomes following transcatheter edge-to-edge repair (TEER) in patients with severe, symptomatic tricuspid regurgitation through a 1-year follow-up.
Methods: The TR-Interventional study (TRIS) is a prospective, single-arm study conducted at the Fondazione Policlinico Universitario Campus Bio-Medico. From March 2021 to December 2023, we enrolled 44 symptomatic patients with at least severe tricuspid regurgitation referred for tricuspid TEER with the TriClip System.
Results: The study cohort had a mean age of 78.3 ± 7 years with a median TRISCORE 5.4% (interquartile range 3.5-9.0). Significant reduction in tricuspid regurgitation grade occurred immediately after the procedure with durable results at 30 days and 1-year follow-up (P < 0.001). The primary efficacy endpoint, which assesses the successful implantation and performance of the device at 30 days, was attained in 82.9% of patients. The secondary efficacy endpoint, evaluating the stability of tricuspid regurgitation reduction at 12 months, was achieved in 82.3% of patients. The NYHA Functional Class and KCCQ scores significantly improved from baseline to 1 year (P < 0.05; P < 0.0001). Echocardiographic assessments reveal sustained positive right ventricle remodeling throughout the 1-year follow-up period.
Conclusion: Evidence from the TRIS study confirms that tricuspid TEER is a valuable and effective therapeutic option in contemporary practice. The lasting reduction in tricuspid regurgitation at 1 year is associated with sustained clinical benefits and reverse structural remodeling of the right ventricle.
期刊介绍:
Journal of Cardiovascular Medicine is a monthly publication of the Italian Federation of Cardiology. It publishes original research articles, epidemiological studies, new methodological clinical approaches, case reports, design and goals of clinical trials, review articles, points of view, editorials and Images in cardiovascular medicine.
Submitted articles undergo a preliminary review by the editor. Some articles may be returned to authors without further consideration. Those being considered for publication will undergo further assessment and peer-review by the editors and those invited to do so from a reviewer pool.