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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.

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.)

Background: Valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) may be associated with adverse hemodynamics, which might affect clinical outcomes., Objectives: This study sought to evaluate the extent and predictors of transcatheter heart valve (THV) deformity in ViV TAVR and the relation to postprocedural hemodynamics., Methods: We examined 53 patients who underwent ViV TAVR in surgical heart valves with self-expanding Evolut prostheses. THV deformation was examined using cardiac computed tomography prospectively performed 30 days after ViV TAVR, and correlated with 30-day echocardiographic hemodynamic data., Results: Near complete expansion of the functional portion of the implanted ViV prostheses (ie, >90%) was observed in 16 (30.2%) patients. Factors related to greater expansion of the functional portion and consequently larger neosinus volume were absence of polymer surgical frame, higher implantation and use of balloon aortic valvuloplasty or bioprosthetic valve fracture during the procedure (all P < 0.05). Underexpansion of the functional portion, but not the valve inflow frame, was closely associated with mean gradient and effective orifice area at 30 days on echocardiography, with and without adjustment for the sizes of the THV and surgical heart valve., Conclusions: Underexpansion of the functional portion of THV prostheses is common during ViV TAVR, occurs more frequently with deep implantation and the presence of a polymer surgical stent frame, and is associated with worse postprocedural hemodynamics. Procedural techniques, such as higher implantation and balloon postdilatation, may be used to help overcome problems with THV underexpansion and improve clinical outcomes., Competing Interests: Funding Support and Author Disclosures Dr Sorajja has received consulting fees from 4C Medical, Abbott Structural, Anteris, Boston Scientific, Edwards Lifesciences, Evolution Medical, Foldax, GLG, Medtronic, Phillips, Siemens, Shifamed, WL Gore, vDyne, and xDot; and received institutional research grant support from Abbott Structural, Medtronic, and Boston Scientific. Dr Cavalcante has received consulting fees from 4C, Abbott Structural, Anteris, AriaCV, Boston Scientific, Edwards Lifesciences, HighLife, Medtronic, VDyne, WL Gore, and Xylocor; and received research grant support from the Abbott Northwestern Hospital Foundation. Dr Enriquez-Sarano has received consulting fees from CryoLife, Edwards Lifesciences, Highlife, and ChemImage. Dr Bapat has received consulting fees from Abbott Structural, Medtronic, Boston Scientific, and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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.)

An increased use of bioprosthetic heart valves has stimulated an interest in possible transcatheter options for bioprosthetic valve failure given the high operative risk. The encouraging results of transcatheter aortic valve implantation in high-risk surgical candidates with native disease have led to the development of the transcatheter valve-in-valve (VIV) procedures for failed bioprostheses. VIV procedures are unique in many ways, and there is an increased need for multimodality imaging in a team-based approach. The echocardiographic approach to VIV procedures has not previously been described. In this review, we summarize key echocardiographic requirements for optimal patient selection, procedural guidance, and immediate post-procedural assessment for VIV procedures., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Surgery remains the only recommended intervention for patients with native aortic regurgitation. A transcatheter therapy to treat patients at high risk for mortality and complications with surgical aortic valve replacement represents an unmet need. Commercial transcatheter heart valves in pure aortic regurgitation are hampered by unacceptable rates of embolisation and paravalvular regurgitation. The Trilogy transcatheter heart valve (JenaValve Technology, Irvine, CA, USA) provides a treatment option for these patients. We report outcomes with transfemoral transcatheter aortic valve implantation (TAVI) in patients with pure aortic regurgitation using this dedicated transcatheter heart valve. The ALIGN-AR trial is a prospective, multicentre, single-arm study. We recruited symptomatic patients (aged ≥18 years) with moderate-to-severe or severe aortic regurgitation at high risk for mortality and complications after surgical aortic valve replacement at 20 US sites for treatment with the Trilogy transcatheter heart valve. The 30-day composite primary safety endpoint was compared for non-inferiority with a prespecified performance goal of 40·5%. The primary efficacy endpoint was 1-year all-cause mortality compared for non-inferiority with a performance goal of 25%. This trial is registered with ClinicalTrials.gov , NCT 04415047, and is ongoing. Between June 8, 2018, and Aug 29, 2022, we screened 346 patients. We excluded 166 (48%) patients and enrolled 180 (52%) patients with symptomatic aortic regurgitation deemed high risk by the heart team and independent screening committee assessments. The mean age of the study population was 75·5 years (SD 10·8), and 85 (47%) were female, 95 (53%) were male, and 131 (73%) were White. Technical success was achieved in 171 (95%) patients. At 30 days, four (2%) deaths, two (1%) disabling strokes, and two (1%) non-disabling strokes occurred. Using standard Valve Academic Research Consortium-2 definitions, the primary safety endpoint was achieved, with events occurring in 48 (27% [97·5% CI 19·2–34·0]) patients (p non-inferiority <0·0001), with new pacemaker implantation in 36 (24%) patients. The primary efficacy endpoint was achieved, with mortality in 14 (7·8% [3·3–12·3]) patients at 1 year (p non-inferiority <0·0001). This study shows the safety and effectiveness of treating native aortic regurgitation using a dedicated transcatheter heart valve to treat patients with symptomatic moderate-to-severe or severe aortic regurgitation who are at high risk for mortality or complications after surgical aortic valve replacement. The observed short-term clinical and haemodynamic outcomes are promising as are signs of left ventricular remodelling, but long-term follow-up is necessary. JenaValve Technology. [ABSTRACT FROM AUTHOR]