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Competing Interests: Funding Support and Author Disclosures Dr Hamid has received consulting fees from Abbott Structural, 4C Medical, Philips Healthcare, GE, Siemens, Edwards Lifesciences, and vDyne. Dr Aman has received consulting fees from Abbott Structural, Philips Healthcare, Silara Medtech, Revalve, and W.L. Gore. Dr Bae has received consulting fees from Abbott Structural. Dr Scherer has received consulting fees from Abbott Structural, Boston Scientific, Edwards Lifesciences, HeartFlow, and Philips Healthcare. Dr Smith has received consulting fees from Abbott Structural, W.L. Gore, Laminar, and Novo Nordisk; and owns equity in Laminar. Dr Schwartz has received consulting fees and education and research support from Edwards Lifesciences, Abbott Vascular, Medtronic, Boston Scientific, Philips Healthcare, Siemens, and Cordis; and served on scientific advisory boards for Medtronic, Cordis, Boston Scientific, and Edwards Lifesciences. Dr Rinaldi has received consulting fees from Abbott Vascular, Edwards Lifesciences, Boston Scientific, Johnson and Johnson, and Abiomed; and served on scientific advisory boards for Abbott Vascular, Edwards Lifesciences, and Boston Scientific. Dr Singh has received consulting fees from and served on the Speakers Bureau for Abbott Structural Heart; and served as a consultant and on the advisory board for Philips Healthcare. Dr Sorajja has received consulting fees from 4C Medical, Abbott Structural, Anteris, Boston Scientific, Edwards Lifesciences, Evolution Medical, Medtronic, Shifamed, TriFlo, vDyne, and W.L. Gore.

Aims: Characterize the impact of residual tricuspid regurgitation (TR) on right ventricle (RV) remodeling and clinical outcomes after transcatheter tricuspid valve intervention., Methods: We performed a single-center retrospective analysis of transcatheter tricuspid valve repair (TTVr) or replacement (TTVR) patients. The primary outcomes were longitudinal tricuspid annular plane systolic excursion (TAPSE), fractional area change (FAC), pulmonary artery systolic pressure (PASP), and RV dimensions (RVd). We used multivariable linear mixed models to evaluate association with replacement versus repair and degree of TR reduction with changes in these echo measures over time. Multivariable Cox regression was used to identify associations between changes in these echo measures and a composite clinical outcome of death, heart failure hospitalization, or re-do tricuspid valve intervention., Results: We included a total of 61 patients; mean age was 77.5 ± 11.7 and 62% were female. TTVR was performed in 25 (41%) and TTVr in 36 (59%). Initially, 72% (n = 44) had ≤ severe TR and 28% (n = 17) had massive or torrential TR. The median number of follow up echos was 2: time to 1st follow-up was 50 days (interquartile range [IQR]: 20, 91) and last follow-up was 147 (IQR: 90, 327). Median TR reduction was 1 (IQR: 0, 2) versus 4 (IQR: 3, 6) grades in TTVr versus TTVR (p < 0.0001). In linear mixed modeling, TTVR was associated with decline in TAPSE and PASP, and TR reduction was associated with decreased RVd. In multivariable Cox regression, greater RVd was associated with the clinical outcome (hazard ratio: 9.27, 95% confidence interval: 1.23-69.88, p = 0.03)., Conclusion: Greater TR reduction is achieved by TTVR versus TTVr, which is in turn associated with RV reverse remodeling. RV dimension in follow-up is associated with increased risk of a composite outcome of death, heart failure hospitalization, or re-do tricuspid valve intervention., (© 2023 Wiley Periodicals LLC.)

Tricuspid regurgitation (TR) is a highly prevalent and heterogeneous valvular disease, independently associated with excess mortality and high morbidity in all clinical contexts. TR is profoundly undertreated by surgery and is often discovered late in patients presenting with right-sided heart failure. To address the issue of undertreatment and poor clinical outcomes without intervention, numerous structural tricuspid interventional devices have been and are in development, a challenging process due to the unique anatomic and physiological characteristics of the tricuspid valve, and warranting well-designed clinical trials. The path from routine practice TR detection to appropriate TR evaluation, to conduction of clinical trials, to enriched therapeutic possibilities for improving TR access to treatment and outcomes in routine practice is complex. Therefore, this paper summarizes the key points and methods crucial to TR detection, quantitation, categorization, risk-scoring, intervention-monitoring, and outcomes evaluation, particularly of right-sided function, and to clinical trial development and conduct, for both interventional and surgical groups., Competing Interests: Funding Support and Author Disclosures Dr Praz has received travel expenses from Edwards Lifesciences, Abbott Vascular, Polares Medical, and Medira. Dr Sorajja has served as a consultant for 4C Medical, Abbott Structural, Boston Scientific, Edwards Lifesciences, Foldax, GE Medical, Medtronic, Philips, Shifamed, Siemens, WL Gore, vDyne, and xDot. Dr Cavalcante has received consulting fees/honoraria from Abbott Structural, Anteris, AriaCV, Boston Scientific, Edwards Lifesciences, Medtronic, VDyne, WL Gore, and Xylocor; and has received research grants from Abbott Northwestern Hospital Foundation and Abbott Structural. Dr Sitges has received speaker honoraria and consultant fees for Abbott, Edwards Lifesciences, Medtronic, and General Electric. Dr Taramasso has acted as a consultant and/or received consultancy fees from Abbott, Edwards Lifescience, Boston Scientific, Medtronic, Shenqi Medical, MEDIRA, Cardiovalve, VentriMend, Simulands, MTEx, Occlufit, CoreMedic, and HeD Imaging; has received an institutional educational grant from Edwards Lifescience and Abbott; and has served on the advisory board for Abbott. Dr Messika-Zeitoun has received research grant from Edwards Lifesciences. Dr Dreyfus has served as a proctor for Abbott. Dr Rudski has small holding of shares in General Electric. Dr Bax has received lecture fees from Abbott and Edwards Lifesciences; and has received unrestricted research grants from Edwards Lifesciences and Abbott. Dr Stephan von Bardeleben has received research support for trials from Abbott, Edwards Lifesciences, Jenavalve, Jenscare, Medtronic, and Neochord. Dr Redwood has served as a proctor and received speaker fees from Edwards; he has also served as on the international advisory board member for Medtronic. Dr Bapat has served as a consultant with Edwards Lifescienes, Medtronic, and Abbott; and has received a research grant from Atricure. Dr Nickenig has received honoraria for lectures or advisory boards from Abbott, Cardiovalve, Edwards, Medtronic, and Boston Scientific. Dr Hausleiter has received research support from Edwards Lifesciences. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; she is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr Maisano has received grant and/or research institutional support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific Corporation, NVT, and Terumo; has received consulting fees, honoraria personal and institutional from Abbott, Medtronic, Edwards Lifesciences, Xeltis, Cardiovalve, Occlufit, Simulands, and Mtex; has received royalty income rights from Edwards Lifesciences; and is a shareholder (including share options) of Cardiogard, Cardiovalve, Magenta, SwissVortex, Transseptalsolutions, 4Tech, and Perifect. Dr Enriquez-Sarano has received consulting fees from Artivion, ChemImage, Edwards Lifescience, HighLife, and Corcym. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Severe tricuspid regurgitation is a debilitating condition that is associated with substantial morbidity and often with poor quality of life. Decreasing tricuspid regurgitation may reduce symptoms and improve clinical outcomes in patients with this disease., Methods: We conducted a prospective randomized trial of percutaneous tricuspid transcatheter edge-to-edge repair (TEER) for severe tricuspid regurgitation. Patients with symptomatic severe tricuspid regurgitation were enrolled at 65 centers in the United States, Canada, and Europe and were randomly assigned in a 1:1 ratio to receive either TEER or medical therapy (control). The primary end point was a hierarchical composite that included death from any cause or tricuspid-valve surgery; hospitalization for heart failure; and an improvement in quality of life as measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ), with an improvement defined as an increase of at least 15 points in the KCCQ score (range, 0 to 100, with higher scores indicating better quality of life) at the 1-year follow-up. The severity of tricuspid regurgitation and safety were also assessed., Results: A total of 350 patients were enrolled; 175 were assigned to each group. The mean age of the patients was 78 years, and 54.9% were women. The results for the primary end point favored the TEER group (win ratio, 1.48; 95% confidence interval, 1.06 to 2.13; P = 0.02). The incidence of death or tricuspid-valve surgery and the rate of hospitalization for heart failure did not appear to differ between the groups. The KCCQ quality-of-life score changed by a mean (±SD) of 12.3±1.8 points in the TEER group, as compared with 0.6±1.8 points in the control group (P<0.001). At 30 days, 87.0% of the patients in the TEER group and 4.8% of those in the control group had tricuspid regurgitation of no greater than moderate severity (P<0.001). TEER was found to be safe; 98.3% of the patients who underwent the procedure were free from major adverse events at 30 days., Conclusions: Tricuspid TEER was safe for patients with severe tricuspid regurgitation, reduced the severity of tricuspid regurgitation, and was associated with an improvement in quality of life. (Funded by Abbott; TRILUMINATE Pivotal ClinicalTrials.gov number, NCT03904147.)., (Copyright © 2023 Massachusetts Medical Society.)

Purpose: This study quantitatively evaluated the phasic right heart morphology of candidate patients for a transcatheter tricuspid valve intervention (N=32) and of subjects with trace to no tricuspid regurgitation (N = 14)., Methods: Cardiac computed tomography angiography (CCTA) and transthoracic/transesophageal echocardiography (TTE/TEE) images were analyzed using dedicated research and clinical software. Using CCTA, the phasic right atrial and ventricular volumes, annulus dimensions, annulus-to-right coronary artery (RCA) distances, circumferential topography of the annular tissue shelf, vena cava dimensions (inferior and superior), vena cava positions, axis angles, and annular excursions were quantified. Using TTE/TEE, leaflet geometry, regurgitation, hemodynamics, and heart function were quantified. Measurements within and between groups were quantitatively compared with regression analyses to explore relationships between right heart features., Results: The phasic position and orientation of the vena cava and the circumferential topography of the annular tissue shelf were quantitatively presented for the first time. The candidate patient group exhibited greater chamber dimensions, enlarged vena cava, distended vena cava positions, positional shallowing of the annular tissue shelf, geometric annular distortion, leaflet distention, moderate or greater regurgitation, and impaired ventricular function. Atrial volume correlated strongly with directional vena cava positions as well as with annular dimensions. Annulus-to-RCA distances and annular excursions were comparable between groups., Conclusions: This study provides new and further insight to the right heart morphology and functional characteristics of candidate patients for a transcatheter tricuspid valve intervention. These data provide a platform from which these patients can continue to be better understood for further improving transcatheter system design and use., (© 2021. The Author(s).)

Objective: The objective of this study was to evaluate the incidence of and risk factors associated with cardiogenic shock (CS) following surgery versus transcatheter tricuspid valve intervention (TTVI) for tricuspid regurgitation (TR)., Background: Surgical therapy for TR is associated with high rates of CS. Postprocedural shock has not been studied following TTVI., Methods: We performed a single-center retrospective analysis of isolated tricuspid valve (TV) surgery or TTVI for TR. The primary outcome was postprocedural class D or E CS according to Society for Cardiovascular Angiography and Interventions (SCAI) CS classification scheme, and secondary outcome was in-hospital mortality. Multivariable logistic regression modeling was performed for primary and secondary outcomes. Support vector machine analysis was performed for sensitivity analysis., Results: From 2008 to 2020, a total of 122 patients underwent isolated TV surgery (n = 58, 14 TV repair, and 44 TV replacement) or TTVI (n = 64, 36 TV repair, and 28 TV replacement). Surgical patients were significantly younger than TTVI patients (67.5 vs. 80 years, p < 0.0001). Multivariable modeling revealed an association between the primary outcome and surgery (odds ratio [OR]: 8.75, 95% confidence interval [CI]: 2.83, 27.03, p = 0.0002), as well as baseline central venous pressure (CVP, OR: 1.12, 95% CI: 1.02, 1.22, p = 0.016). Additionally, class DE CS was independently associated with in-hospital mortality (OR: 5.21, 1.35, 20.09, p = 0.016). CVP and surgery were found to have highest importance indices in support vector machine analysis., Conclusion: In patients undergoing TV intervention for TR, surgery versus TTVI and elevated CVP are associated with advanced postprocedural CS. Patients developing advanced CS are at increased risk of in-hospital mortality., (© 2022 Wiley Periodicals LLC.)

Objectives: The purpose of this study was to characterize the anatomic relationship between the inferior vena cava (IVC) and tricuspid annulus (TA) and its potential impact on the performance of transcatheter TV interventions., Background: Transcatheter tricuspid valve (TV) interventions are emerging as a therapeutic alternative for the treatment of severe, symptomatic tricuspid regurgitation (TR). Progression of TR is associated with right heart dilatation. These anatomic changes may distort the IVC-TA relationship and impact successful implantation of transcatheter devices., Methods: Fifty patients who presented with symptomatic TR for consideration of transcatheter TV therapy with an available CT were included in the study. Comprehensive transesophageal echocardiogram and CT analyses were performed to assess the right-sided cardiac chambers, TA and IVC-TA relationship., Results: The mean age of the study cohort was 78.4 ± 8.9 years. Torrential TR was present in 54% (n = 27). There was considerable variation in the short axis mid-IVC to mid-TA offset (SAX MID 18.2 ± 7.9 mm, range 4.7-42.1 mm)., Conclusions: The IVC-to-TA relationship exhibits significant variability in patients with symptomatic TR. CT analysis of the tricuspid anatomy, including the relationship to the surrounding structures and the IVC, is essential for planning transcatheter TV interventions. Further studies are needed to define whether the IVC-to-TA relationship is a predictor of technical success in the context of specific transcatheter delivery systems., (© 2022 Wiley Periodicals LLC.)