Tricuspid Valve Academic Research Consortium Definitions for Tricuspid Regurgitation and Trial Endpoints

Abstract

Interest in the pathophysiology, etiology, management, and outcomes of patients with tricuspid regurgitation (TR) has grown in the wake of multiple natural history studies showing progressively worse outcomes associated with increasing TR severity, even after adjusting for multiple comorbidities. Historically, isolated tricuspid valve surgery has been associated with high in-hospital mortality rates, leading to the development of transcatheter treatment options. The aim of this first Tricuspid Valve Academic Research Consortium document is to standardize definitions of disease etiology and severity, as well as endpoints for trials that aim to address the gaps in our knowledge related to identification and management of patients with TR. Standardizing endpoints for trials should provide consistency and enable meaningful comparisons between clinical trials. A second Tricuspid Valve Academic Research Consortium document will focus on further defining trial endpoints and will discuss trial design options. Interest in the pathophysiology, etiology, management, and outcomes of patients with tricuspid regurgitation (TR) has grown in the wake of multiple natural history studies showing progressively worse outcomes associated with increasing TR severity, even after adjusting for multiple comorbidities. Historically, isolated tricuspid valve surgery has been associated with high in-hospital mortality rates, leading to the development of transcatheter treatment options. The aim of this first Tricuspid Valve Academic Research Consortium document is to standardize definitions of disease etiology and severity, as well as endpoints for trials that aim to address the gaps in our knowledge related to identification and management of patients with TR. Standardizing endpoints for trials should provide consistency and enable meaningful comparisons between clinical trials. A second Tricuspid Valve Academic Research Consortium document will focus on further defining trial endpoints and will discuss trial design options. The Supplemental Material can be viewed in the online version of this article [https://dx.doi.org/10.1016/j.athoracsur.2023.09.018] on https://www.annalsthoracicsurgery.org. The Supplemental Material can be viewed in the online version of this article [https://dx.doi.org/10.1016/j.athoracsur.2023.09.018] on https://www.annalsthoracicsurgery.org. Interest in the pathophysiology, etiology, management, and outcomes of patients with tricuspid regurgitation (TR) has grown significantly over the last 10 years given the natural history studies showing a high disease prevalence1Topilsky Y. Maltais S. Medina Inojosa J. et al.Burden of tricuspid regurgitation in patients diagnosed in the community setting.J Am Coll Cardiol Img. 2019; 12: 433-442Crossref Scopus (357) Google Scholar, 2Tung M. Nah G. Tang J. Marcus G. Delling F.N. Valvular disease burden in the modern era of percutaneous and surgical interventions: the UK Biobank.Open Heart. 2022; 9e002039https://doi.org/10.1136/openhrt-2022-002039Crossref PubMed Scopus (3) Google Scholar, 3Offen S. Playford D. Strange G. Stewart S. Celermajer D.S. Adverse prognostic impact of even mild or moderate tricuspid regurgitation: insights from the National Echocardiography Database of Australia.J Am Soc Echocardiogr. 2022; 35: 810-817Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar and poor outcomes associated with increasing TR severity, even after adjusting for comorbidities.3Offen S. Playford D. Strange G. Stewart S. Celermajer D.S. Adverse prognostic impact of even mild or moderate tricuspid regurgitation: insights from the National Echocardiography Database of Australia.J Am Soc Echocardiogr. 2022; 35: 810-817Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar, 4Chorin E. Rozenbaum Z. Topilsky Y. et al.Tricuspid regurgitation and long-term clinical outcomes.Eur Heart J Cardiovasc Imaging. 2020; 21: 157-165PubMed Google Scholar, 5Wang N. Fulcher J. Abeysuriya N. et al.Tricuspid regurgitation is associated with increased mortality independent of pulmonary pressures and right heart failure: a systematic review and meta-analysis.Eur Heart J. 2019; 40: 476-484Crossref PubMed Scopus (163) Google Scholar However, a number of gaps in our understanding of the disease as well as the rapid expansion of transcatheter solutions for structural heart disease have increased the need for further research and trials. Indications for isolated tricuspid valve (TV) surgery have poor penetration into clinical practice, which may be related to reported high in-hospital mortality rates, partly associated with late clinical diagnosis.6Scotti A. Sturla M. Granada J.F. et al.Outcomes of isolated tricuspid valve replacement: a systematic review and meta-analysis of 5,316 patients from 35 studies.EuroIntervention. 2022; 18: 840-851Crossref PubMed Scopus (12) Google Scholar Transcatheter alternatives to surgical intervention are being investigated; yet, appropriate patient selection, goals of therapy, and clinically meaningful outcomes are unknown. Considering these challenges, standardized clinical trial pathways and endpoint definitions to evaluate treatment outcomes in TR patients are needed. The Heart Valve Collaboratory is a multidisciplinary community of physicians, regulators, industry partners, and patient advocates who organized a comprehensive meeting to define the knowledge gaps in our understanding of TR, standardize definitions and methods to assess disease severity, and develop feasible and efficient trial designs. This first Tricuspid Valve Academic Research Consortium (TVARC) document describes the current understanding of the disease state, natural history, and treatment options. The paper includes a proposal for general categories of clinical trial endpoints. A second planned TVARC document will focus on further defining trial endpoints and discusses trial design options. Importantly, TVARC is not a guideline intended to influence clinical practice, but is a document intended to inform clinical research and, in particular, clinical trials. Unlike a guideline, which must rely on evidence-based medicine for recommendations, this document aims to standardize trial endpoints to address gaps in our knowledge related to identification and management of patients with TR. Standardizing endpoints for trials should provide consistency across trials and may strengthen the evidence required for guideline recommendations. Given the dynamic field of TR therapeutics, our understanding of its disease state will likely increase with time, and as treatment options expand, trial design and endpoints will undoubtedly evolve. This document is, therefore, intended to be a “living document,” which will allow periodic updating as our knowledge expands. In the current literature, various abbreviations are used for the description of transcatheter valve procedures. Table 1 shows standardized common abbreviations within this academic research consortium.Table 1Suggested Standardized Abbreviations in the Context of Tricuspid Valve InterventionsAbbreviationFull NameDescriptionTTVITranscatheter tricuspid valve interventionTo be used for any tricuspid valve repair or replacement techniqueTTVRTranscatheter tricuspid valve replacementTo be used for any tricuspid valve replacement, including orthotopic and heterotopic techniquesT-TEERTricuspid valve transcatheter edge-to-edge repairTo be used for tricuspid leaflet-based edge-to-edge repair techniquesTTV RepairTranscatheter tricuspid valve repairTo be used for any tricuspid valve repair techniqueA-STRAtrial secondary tricuspid regurgitantTo be used to indicate secondary tricuspid regurgitation with atrial/annular dilatation as the main mechanism of regurgitationV-STRVentricular secondary tricuspid regurgitationTo be used to indicate secondary tricuspid regurgitation with ventricular dilatation/dysfunction as the main mechanism of regurgitationPTRPrimary tricuspid regurgitationTo be used to indicate tricuspid regurgitation caused by leaflet abnormalitiesLTR-ALead-associated tricuspid regurgitation, type ATo be used to indicate tricuspid regurgitation caused by cardiac implantable electronic device caused regurgitationLTR-BLead-associated tricuspid regurgitation, type BTo be used to indicate tricuspid regurgitation not related directly to cardiac implantable electronic device Open table in a new tab Historically, TR is viewed as a binary classification, which includes primary TR, where leaflet abnormalities are the cause of regurgitation, and secondary diseases, where leaflets are normal but structural changes of the annulus or right ventricle (RV) result in insufficient leaflet coaptation. Currently, a more comprehensive classification system for TR etiologies more appropriately encompasses the pathophysiology of this multifaceted disease (Table 2, Figure 1).7Praz F. Muraru D. Kreidel F. et al.Transcatheter treatment for tricuspid valve disease.EuroIntervention. 2021; 17: 791-808Crossref PubMed Scopus (91) Google Scholar,8Lancellotti J. et of regurgitation: and of Valvular Heart Heart J Cardiovasc Imaging. 2022; PubMed Scopus Google Scholar TR etiologies may be associated with M. Topilsky Y. of tricuspid regurgitation: and prognostic Am Coll Cardiol Img. 2019; 12: Scopus Google Scholar, et in etiology and in patients with tricuspid J 2021; Full Text Full Text PDF PubMed Scopus Google Scholar, M. F. et secondary tricuspid regurgitation is associated to more the ventricular Cardiovasc 2022; Scopus Google Scholar, F. et tricuspid regurgitation: and impact on Cardiovasc 2022; PubMed Scopus Google Scholar a of current classification The main changes to the TR classification the secondary TR into secondary tricuspid regurgitation and ventricular secondary tricuspid regurgitation a for TR associated with cardiac implantable electronic device as tricuspid regurgitation and into type A is the TR, and type is (Table 2, Figure mechanism of secondary TR may be by changes that as a result of the changes associated with a disease of TR by and TR of or leaflet normal of leaflet leaflet or or leaflet normal or TR may result in with leaflet of secondary ventricular dilatation leaflet or heart or or dilatation and secondary TR may result in with leaflet dilatation related to dilatation/dysfunction dilatation leaflet TR leaflet or may be and not the mechanism of tricuspid regurgitation, may impact transcatheter device tricuspid valve on primary disease or implantable electronic pulmonary heart with heart with tricuspid regurgitation, type tricuspid regurgitation, type pulmonary pulmonary right heart right tricuspid TR, tricuspid TR may result in with leaflet may be and not the mechanism of tricuspid regurgitation, may impact transcatheter device Open table in a new tab implantable electronic pulmonary heart with heart with tricuspid regurgitation, type tricuspid regurgitation, type pulmonary pulmonary right heart right tricuspid TR, tricuspid Given the that patients with have outcomes with M. 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