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Objective: Globally significant variation in treatment and course of heart valve disease (HVD) exists, and outcome measurement is procedure focused instead of patient focused. This article describes the development of a patient-related (International Consortium for Health Outcomes Measurement) standard set of outcomes and case mix to be measured in patients with HVD., Methods: A multisociety working group was formed that included patient representatives and representatives from scientific cardiology and cardiothoracic surgery societies that publish current guidelines for HVD. The standard set was developed to monitor the patient's journey from diagnosis to treatment with either a surgical or transcatheter procedure. Candidate clinical and patient-reported outcome measures (PROMs) and case mix were identified through benchmark analyses and systematic reviews. Using an online modified Delphi process, the working group voted on final outcomes/case mix and corresponding definition., Results: Patients with aortic/mitral/tricuspid valve disease or root/ascending aorta >40 mm were included in the standard set. Patients entered the dataset when the diagnosis of HVD was established, allowing outcome measurement in the preprocedural, periprocedural, and postprocedural phases of patients' lives. The working group defined 5 outcome domains: vital status, patient-reported outcomes, progression of disease, cardiac function and durability, and complications of treatment. Subsequently, 16 outcome measures, including 2 patient-reported outcomes, were selected to be tracked in patients with HVD. Case-mix variables included demographic factors, demographic variables, echocardiographic variables, heart catheterization variables, and specific details on aortic/mitral/tricuspid valves and their specific interventions., Conclusions: Through a unique collaborative effort between patients and cardiology and cardiothoracic surgery societies, a standard set of measures for HVD was developed. This dataset focuses on outcome measurement regardless of treatment, moving from procedure- to patient-centered outcomes. Implementation of this dataset will facilitate global standardization of outcome measurement, allow meaningful comparison between health care systems and evaluation of clinical practice guidelines, and eventually improve patient care for those experiencing HVD worldwide., Competing Interests: Declaration of Conflicting InterestsThe authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: E.A. has received research funding from the National Institutes of Health. S.A. has received meeting/travel support from the European Society of Cardiology; participated in Data Management and Analysis Group of the British Intervention Cardiovascular Society; and is a Leader of the Quality of Care group of the European Society of Cardiology. A.A.A. has received payment/honoraria fees from Abbott Medical Pty Ltd and Corcym Pty Ltd. H.H.B. has received consulting fees for being a proctor for Intuitive Surgical; has received lecture honoraria from Medtronic and Edwards Lifesciences; has served on a data safety monitoring board for Edwards Lifesciences; and has served in leadership positions for ISMICS, SRS, STS, and ACS. P.B.J., via ICHOM, received funding from Adetec Coeur and Edwards Lifesciences for this project. Z.D-S., via ICHOM, received funding from Adetec Coeur and Edwards Lifesciences for this project. D.E. has received research and advisory collaboration with GE Healthcare and Abbott Vascular. G.E. has received speaker honoraria (payments to the institution) from Edwards Lifesciences, Medela, and AstraZeneca. R.T.H. has received honoraria for lectures from Boston Scientific, Edwards Lifesciences, and Philips Healthcare; and Institutional Consulting Contracts (no direct compensation) from Abbott, Anteris, Boston Scientific, and Novartis. A.J. has been a senior project leader for the development of the standard set for heart valve disease, which entails development of study materials, leading the working group through the process, and quality assurance of all materials. E.L. has received a patent for extra aortic ring from Coroneo Inc; and has received royalties/licenses for a patent extra aortic ring from Coroneo Inc. B.M. has received consulting fees from Corcym, Edwards Lifesciences, and Novostia; and has received honoraria for lectures/presentations from Medtronic. P.P. has received institutional funding with no direct compensation from Novartis, Edwards Lifesciences, Medtronic, Pi-Cardia, and Cardiac Success; has received honoraria for lectures/presentations from Edwards Lifesciences; and has participated on an advisory board for Medtronic. O.P. has been co-chair of ACC/AHA guidelines on aortic disease (2022); has served as a member of the EACTS/STS guidelines on aortic disease (2024); and has been a consultant (no fees) for W.L. Gore and Associates, Terumo Aortic, Intressa Vasc, and AbioMed. V.R. has participated on an advisory board for Rednvia Co, Ltd (Adaptive Phase 2/3 Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel, 3 Arm Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient’s Calcific Aortic Valve Disease with Mild to Moderate Aortic Stenosis [EVOID-AS]); has received stock from Amgen, Edwards Lifesciences, Intuitive Surgical, Inc, Bristol Myers Squibb, Merck-Schering Plough, Viatris, Organon, Regeneron, and AstraZeneca. F.J.S. has received consulting fees as a paid consultant and SAB member for Xeltis; and has received support for meetings/travel as a paid consultant and SAB member Xeltis. P.S. has received support (payments to institution) from Edwards Lifesciences and support (InstitutionEd) from Medtronic; has received honoraria for lectures/presentations from Edwards; has served on a data safety monitoring board for Anteris; and has received stock/stock options from Xenter. M. Sitges has received consulting fees from Edwards Lifesciences and Abbott; has received honoraria for lectures/presentations from Edwards Lifesciences, Abbott, Medtronic, General Electric, and Siemens Healthineers; has received payment for expert testimony from Abbott and General Electric; has received meeting/travel support from Abbott and Edwards Lifesciences; has served as past president of the Heart Valve Society; has been elected president of the Societat Catalana de Cardiologia; and has served with the Tricuspid Focus Group PCR. M. Szerlip has received honoraria for lectures/presentations from Edwards Lifesciences, CVI, SCAI, and Boston Scientific; has served on a data safety monitoring board for Abbott Vascular; and is a member of the Baylor Scott and White Heart Hospital Board, the SCAI Board of Trustees, and the IAGS Board. W.Y.S. has received honoraria for lectures/presentations from Edwards Lifesciences, Medtronic, Abbott, Terumo Aortic, and Artivion. J.J.M.T. is past president and senior advisor to Heart Valve Society Board. V.H.T. has received consulting fees from Abbott Vascular, Artivion, Boston Scientific, CroíValve, Edwards Lifesciences, Articure, and Egnite Medical; and has received equity from Dasi Simulations and Trisol. F.B., D.C., G.D., H.J., J.K., S.M., R.M., R.S., F.S., J.S., K.V., W.W., and A.Z. have reported that they have no relationships relevant to the contents of this paper to disclose.

Background: Globally significant variation in treatment and course of heart valve disease (HVD) exists, and outcome measurement is procedure focused instead of patient focused. This article describes the development of a patient-related (International Consortium for Health Outcomes Measurement) standard set of outcomes and case mix to be measured in patients with HVD., Methods: A multisociety working group was formed that included patient representatives and representatives from scientific cardiology and cardiothoracic surgery societies that publish current guidelines for HVD. The standard set was developed to monitor the patient's journey from diagnosis to treatment with either a surgical or transcatheter procedure. Candidate clinical and patient-reported outcome measures (PROMs) and case mix were identified through benchmark analyses and systematic reviews. Using an online modified Delphi process, the working group voted on final outcomes/case mix and corresponding definition., Results: Patients with aortic/mitral/tricuspid valve disease or root/ascending aorta >40 mm were included in the standard set. Patients entered the dataset when the diagnosis of HVD was established, allowing outcome measurement in the preprocedural, periprocedural, and postprocedural phases of patients' lives. The working group defined 5 outcome domains: vital status, patient-reported outcomes, progression of disease, cardiac function and durability, and complications of treatment. Subsequently, 16 outcome measures, including 2 patient-reported outcomes, were selected to be tracked in patients with HVD. Case-mix variables included demographic factors, demographic variables, echocardiographic variables, heart catheterization variables, and specific details on aortic/mitral/tricuspid valves and their specific interventions., Conclusions: Through a unique collaborative effort between patients and cardiology and cardiothoracic surgery societies, a standard set of measures for HVD was developed. This dataset focuses on outcome measurement regardless of treatment, moving from procedure- to patient-centered outcomes. Implementation of this dataset will facilitate global standardization of outcome measurement, allow meaningful comparison between health care systems and evaluation of clinical practice guidelines, and eventually improve patient care for those experiencing HVD worldwide., Competing Interests: Funding Support and Author Disclosures E.A. has received research funding from the National Institutes of Health. S.A. has received meeting/travel support from the European Society of Cardiology; participated in Data Management and Analysis Group of the British Intervention Cardiovascular Society; and is a Leader of the Quality of Care group of the European Society of Cardiology. A.A.A. has received payment/honoraria fees from Abbott Medical Pty Ltd and Corcym Pty Ltd. H.H.B. has received consulting fees for being a proctor for Intuitive Surgical; has received lecture honoraria from Medtronic and Edwards Lifesciences; has served on a data safety monitoring board for Edwards Lifesciences; and has served in leadership positions for ISMICS, SRS, STS, and ACS. P.B.J., via ICHOM, received funding from Adetec Coeur and Edwards Lifesciences for this project. Z.D-S., via ICHOM, received funding from Adetec Coeur and Edwards Lifesciences for this project. D.E. has received research and advisory collaboration with GE Healthcare and Abbott Vascular. G.E. has received speaker honoraria (payments to the institution) from Edwards Lifesciences, Medela, and AstraZeneca. R.T.H. has received honoraria for lectures from Boston Scientific, Edwards Lifesciences, and Philips Healthcare; and Institutional Consulting Contracts (no direct compensation) from Abbott, Anteris, Boston Scientific, and Novartis. A.J. has been a senior project leader for the development of the standard set for heart valve disease, which entails development of study materials, leading the working group through the process, and quality assurance of all materials. E.L. has received a patent for extra aortic ring from Coroneo Inc; and has received royalties/licenses for a patent extra aortic ring from Coroneo Inc. B.M. has received consulting fees from Corcym, Edwards Lifesciences, and Novostia; and has received honoraria for lectures/presentations from Medtronic. P.P. has received institutional funding with no direct compensation from Novartis, Edwards Lifesciences, Medtronic, Pi-Cardia, and Cardiac Success; has received honoraria for lectures/presentations from Edwards Lifesciences; and has participated on an advisory board for Medtronic. O.P. has been co-chair of ACC/AHA guidelines on aortic disease (2022); has served as a member of the EACTS/STS guidelines on aortic disease (2024); and has been a consultant (no fees) for W.L. Gore and Associates, Terumo Aortic, Intressa Vasc, and AbioMed. V.R. has participated on an advisory board for Rednvia Co, Ltd (Adaptive Phase 2/3 Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel, 3 Arm Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient’s Calcific Aortic Valve Disease with Mild to Moderate Aortic Stenosis [EVOID-AS]); has received stock from Amgen, Edwards Lifesciences, Intuitive Surgical, Inc, Bristol Myers Squibb, Merck-Schering Plough, Viatris, Organon, Regeneron, and AstraZeneca. F.J.S. has received consulting fees as a paid consultant and SAB member for Xeltis; and has received support for meetings/travel as a paid consultant and SAB member Xeltis. P.S. has received support (payments to institution) from Edwards Lifesciences and support (InstitutionEd) from Medtronic; has received honoraria for lectures/presentations from Edwards; has served on a data safety monitoring board for Anteris; and has received stock/stock options from Xenter. M. Sitges has received consulting fees from Edwards Lifesciences and Abbott; has received honoraria for lectures/presentations from Edwards Lifesciences, Abbott, Medtronic, General Electric, and Siemens Healthineers; has received payment for expert testimony from Abbott and General Electric; has received meeting/travel support from Abbott and Edwards Lifesciences; has served as past president of the Heart Valve Society; has been elected president of the Societat Catalana de Cardiologia; and has served with the Tricuspid Focus Group PCR. M. Szerlip has received honoraria for lectures/presentations from Edwards Lifesciences, CVI, SCAI, and Boston Scientific; has served on a data safety monitoring board for Abbott Vascular; and is a member of the Baylor Scott and White Heart Hospital Board, the SCAI Board of Trustees, and the IAGS Board. W.Y.S. has received honoraria for lectures/presentations from Edwards Lifesciences, Medtronic, Abbott, Terumo Aortic, and Artivion. J.J.M.T. is past president and senior advisor to Heart Valve Society Board. V.H.T. has received consulting fees from Abbott Vascular, Artivion, Boston Scientific, CroíValve, Edwards Lifesciences, Articure, and Egnite Medical; and has received equity from Dasi Simulations and Trisol. F.B., D.C., G.D., H.J., J.K., S.M., R.M., R.S., F.S., J.S., K.V., W.W., and A.Z. have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: The development and progression of aortic stenosis (AS) from aortic valve (AV) sclerosis is highly variable and difficult to predict., Objectives: The authors investigated whether a previously validated echocardiography-based deep learning (DL) model assessing diastolic dysfunction (DD) could identify the latent risk associated with the development and progression of AS., Methods: The authors evaluated 898 participants with AV sclerosis from the ARIC (Atherosclerosis Risk In Communities) cohort study and associated the DL-predicted probability of DD with 2 endpoints: 1) the new diagnosis of AS; and 2) the composite of subsequent mortality or AV interventions. Validation was performed in 2 additional cohorts: 1) in 50 patients with mild-to-moderate AS undergoing cardiac magnetic resonance (CMR) imaging and serial echocardiographic assessments; and 2) in 18 patients with AV sclerosis undergoing 18 F-sodium fluoride (NaF) and 18 F-fluorodeoxyglucose positron emission tomography (PET) combined with computed tomography (CT) to assess valvular inflammation and calcification., Results: In the ARIC cohort, a higher DL-predicted probability of DD was associated with the development of AS (adjusted HR: 3.482 [95% CI: 2.061-5.884]; P < 0.001) and subsequent mortality or AV interventions (adjusted HR: 7.033 [95% CI: 3.036-16.290]; P < 0.001). The multivariable Cox model (incorporating the DL-predicted probability of DD) derived from the ARIC cohort efficiently predicted the progression of AS (C-index: 0.798 [95% CI: 0.648-0.948]) in the CMR cohort. Moreover, the predictions of this multivariable Cox model correlated positively with valvular 18 F-NaF mean standardized uptake values in the PET/CT cohort (r = 0.62; P = 0.008)., Conclusions: Assessment of DD using DL can stratify the latent risk associated with the progression of early-stage AS., Competing Interests: Funding Support and Author Disclosures The work presented in this paper was supported in part by funds from the National Science Foundation (award number: 1920920). Dr Tokodi was supported by the New National Excellence Program (ÚNKP-23-4-II-SE-39) of the Ministry of Culture and Innovation in Hungary from the National Research, Development, and Innovation Fund. Dr Tokodi has received consulting fees from CardioSight outside the submitted work. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, and Edwards Lifesciences; has institutional educational and consulting contracts for which she receives no direct compensation, with Abbott Structural, Boston Scientific, Edwards Lifesciences, and Medtronic; and is the 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 Dweck is supported by the British Heart Foundation (FS/14/78/31020); has received the Sir Jules Thorn Award for Biomedical Research 2015 (15/JTA); and has received speaker fees from Pfizer, Radcliffe Cardiology, Bristol Myers Squibb, Edwards, and Novartis and consulting fees from Novartis, Jupiter Bioventures, Beren, and Silence Therapeutics. Dr Pibarot has received funding from Edwards Lifesciences, Medtronic, Pi-Cardia, and Cardiac Success for echocardiography core laboratory analyses and research studies in transcatheter valve therapies, for which he received no personal compensation; and has received lecture fees from Edwards Lifesciences and Medtronic. Dr Yanamala serves as an advisor for Turnkey Techstart. Dr Sengupta serves as an advisor for RCE Technologies and HeartSciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Right ventricular (RV) heart failure as assessed by RV to pulmonary artery coupling (RVPAc) is a prognostic marker in transcatheter tricuspid valve repair (T-TEER). However, quantification of RVPAc components by 2D echocardiography in patients with severe tricuspid regurgitation (TR) has significant limitations, and the traditional RVPAc parameter neglects the degree of volume overload/dilatation of the RV, which is another key clinical indicator for right ventricular dysfunction (RVD).Therefore, we aimed to assess RVD by a novel RVPAc parameter, including the three important drivers of RVD, for an improved prediction of 1-year mortality after T-TEER., Methods: We analyzed 262 patients undergoing T-TEER with complete 3D RV echocardiography and 1-year follow-up., Results: Increased 3D-RV enddiastolic volume (3D-RVEDV: HR 1.85; 1.10-3.12; p=0.020) and impaired RV free wall longitudinal strain (RVFWLS: hazard ratio (HR) 1.73, 1.02-2.92, p=0.042) predicted 1-year mortality. A novel RVPAc parameter [RVFWLS/(3D-RVEDV*sPAP invasive )] including all 3 important drivers for RVD was developed, associating RVPA-uncoupling with a tripled risk for 1-year mortality (HR 3.19, 1.7-6.0, p<0.001). The novel RVPAc parameter significantly outperformed the traditional non-invasive RVPAc parameter in 1-year mortality prediction (c-index: 0.68 vs. 0.57 for novel vs. traditional non-invasive RVPAc; p=0.027)., Conclusions: The novel RVPAc parameter, integrating RV function, volume stress, and pressure stress is a powerful metric for RV failure and a superior predictor for survival post-T-TEER., (Copyright © 2025. Published by Elsevier Inc.)

Background: The impact of tricuspid regurgitation (TR) on cardiac remodeling has not been thoroughly studied in a randomized controlled trial using advanced imaging., Objectives: The goal of this analysis was to provide comparative longitudinal changes in right heart remodeling using cardiac magnetic resonance and time-resolved functional computed tomography (4D-CT) in patients with symptomatic severe TR randomized to TriClip vs medical therapy (control)., Methods: TRILUMINATE Pivotal (Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal) is an international randomized controlled trial in symptomatic patients with severe TR. A prospective imaging substudy was performed on TRILUMINATE Pivotal subjects at 10 sites. Cardiac magnetic resonance and 4D-CT were performed following dedicated imaging protocols at baseline and at 30 days, and a final 4D-CT at 1 year (all assessed by an imaging core lab)., Results: Sixty-nine randomized subjects (31 TriClip, 38 control) were enrolled. TR volume significantly decreased with TriClip at 30 days (P < 0.0001; 70% reduction). A strong association (r = 0.90; P < 0.0001) was observed between changes in TR volume and right ventricular end-diastolic volume at 30 days. Significant reductions in right ventricular end-diastolic volume (12% reduction; P < 0.001) and tricuspid annular area (11% reduction; P < 0.0001) were seen at 30 days and sustained through 1 year with TriClip. No meaningful changes were observed in the control group., Conclusions: Advanced imaging from the TRILUMINATE Pivotal imaging substudy demonstrated that TriClip effectively reduced TR. Significant cardiac remodeling was observed at 30 days and sustained at 1 year. With TriClip, the extent of cardiac remodeling was associated with the degree of TR reduction. (Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal; NCT03904147)., Competing Interests: Funding Support and Author Disclosures This study was funded by Abbott. Dr Cavalcante has received consulting fees from 4C Medical, Abbott, Alleviant, Anteris, Boston Scientific, Circle Cardiovascular Imaging, Edwards Lifesciences, JenaValve, JC Medical, Medtronic, Novo Nordisk, Pie Medical, Siemens Healthineers, Shockwave, and Zoll; and has received research grant support from Abbott Structural, Allina Health Foundation, JenaValve, and National Institutes of Health (NIH)/National Heart, Lung, and Blood Institute (NHLBI). Dr Scherer has received consulting/speaker fees/honoraria from Abbott, Boston Scientific, Edwards Lifesciences, HeartFlow, Philips, and Siemens; and has received institutional grant/research support from Boston Scientific and HeartFlow. Dr Fukui has served as a consultant for Edwards Lifesciences and Anteris. Dr Harb has served as a speaker for Edwards Lifesciences; and has served as a consultant and speaker for Abbott, Boston Scientific, and TeraRecon. Dr Schwartz has served as a consultant for Abbott, Boston Scientific, Cordis, Edwards Lifesciences, Medtronic, and Phillips. Dr Ricciardi has received consultant and speaker fees from Abbott. Dr Khalique has received consulting fees from Siemens, Philips, Edwards, Croivalve, Triflo, and Restore Medical. Dr Kodali has received grant/research support from Boston Scientific, Edwards Lifesciences, and Medtronic; has received consulting fees/honoraria from Ancora Heart Inc, Aria CV Inc, Dura Biotech, Thubrikar Aortic Valve Inc, and Valfix Medical; and has owned equity from Admedus Regen Pty Ltd., Dura Biotech, Supira Medical, and Trisol Medical. Dr Whisenant has received consulting fees/honoraria from Abbott and Edwards Lifesciences. Dr Yadav is a consultant/speaker for Edwards Lifesciences, Abbott Vascular, Boston Scientific, and Medtronic; is on the Medical Advisory Board of Dasi Simulations, Trisol, and Opus; and has equity in Dasi Simulations and Opus. Dr Emaminia has received consultant fees from Abbott. Dr Batchelor has consulted for Abbott, Edwards, Boston Scientific, and Medtronic; and has received research support from Abbott and Boston Scientific. Dr Lin is an employee of Abbott. Dr Trusty is an employee of Abbott. Dr Hahn has served as a speaker for Abbott, Baylis Medical, Edwards Lifesciences, and Philips. Dr Adams has served as the national coprincipal investigator of Abbott TRILUMINATE Pivotal Trial, Medtronic APOLLO U.S. Pivotal Trial, ReChord U.S. Pivotal Trial, and Medtronic CoreValve U.S. Pivotal Trial. Dr Sorajja has served as a consultant for Boston Scientific, Edwards Lifesciences, Evolution Medical, Medtronic, Shifamed, TriFlo, and WL Gore; has served as a member of the advisory board for VDyne and Anteris; and has served as the principal investigator of clinical trials for Abbott and HighLife. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2025 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Tricuspid regurgitation (TR) is a right-sided valvular disease independently associated with morbidity and mortality. The TRILUMINATE Pivotal (Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal) is the first randomized controlled trial assessing the impact of TR reduction with tricuspid transcatheter edge-to-edge repair (T-TEER)., Objectives: Outcomes from the full randomized cohort of the TRILUMINATE Pivotal trial have not been previously reported, and the additional enrollment may further support the safety and effectiveness of T-TEER through 1 year., Methods: The TRILUMINATE Pivotal trial is an international randomized controlled trial of T-TEER with the TriClip device in patients with symptomatic, severe TR. Adaptive trial design allowed enrollment past the primary analysis population. The primary outcome was a hierarchical composite of all-cause mortality or tricuspid valve surgery, heart failure hospitalizations (HFHs), and quality-of-life improvement measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 1 year., Results: Between August 21, 2019, and June 29, 2022, 572 subjects were randomized, including the primary cohort (n = 350) and subsequent enrollment (n = 222). Subjects were older (78.1 ± 7.8 years) and predominantly female (58.9%), with atrial fibrillation (87.8%) and prior HFH (23.8%). The primary endpoint was met for the full cohort (win ratio = 1.84; P < 0.0001). Freedom from all-cause mortality and tricuspid valve surgery through 12 months was 90.6% and 89.9% for the device and control groups, respectively (P = 0.82). Annualized HFH rate was comparable between device and control subjects (0.17 vs 0.20 events/patient-year; P = 0.40). A significant treatment effect was observed for change in quality of life with 52.3% of device subjects achieving a ≥15-point KCCQ score improvement (compared with 23.5% of control subjects; P < 0.0001). All secondary endpoints favored T-TEER: moderate or less TR at 30 days (88.9% vs 5.3%; P < 0.0001), KCCQ change at 1 year (13.0 ± 1.4 points vs -0.5 ± 1.4 points; P < 0.0001), and 6-minute walk distance change at 1 year (1.7 ± 7.5 m vs -27.4 ± 7.4 m; P < 0.0001). Freedom from major adverse events was 98.9% for T-TEER (vs performance goal: 90%; P < 0.0001)., Conclusions: TriClip was safe and effective in the full randomized cohort of TRILUMINATE Pivotal with significant TR reduction and improvements in 6-minute walk distance and health status. Rates of all-cause mortality or tricuspid valve surgery and HFH through 1 year were not reduced by T-TEER., Competing Interests: Funding Support and Author Disclosures The TRILUMINATE Pivotal trial (NCT03904147) was funded by Abbott. Dr Tang has received speaker honoraria and served as a physician proctor, consultant, advisory board member, TAVR publications committee member, RESTORE study steering committee member, APOLLO trial screening committee member, and IMPACT MR steering committee member for Medtronic; has received speaker honoraria and served as a physician proctor, consultant, advisory board member, and TRILUMINATE trial anatomic eligibility and publications committee member for Abbott Structural Heart; has served as an advisory board member for Boston Scientific and JenaValve; has served as a consultant and physician screening committee member for Shockwave Medical; has served as a consultant for NeoChord, Peija Medical, and Shenqi Medical Technology; and has received speaker's honoraria from Siemens Healthineers. 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, Anteris, Boston Scientific, Edwards Lifesciences, Medtronic, Novartis, and Philips Healthcare; and is chief scientific officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored valve trials, for which she receives no direct industry compensation. Dr Whisenant has received consulting fees from Abbott and Edwards Lifesciences. Dr Hamid has received consulting fees from 4C Medical Technologies, Inc., Alleviant Medical, Inc., AMX, Anteris Technologies Corporation, Edwards Lifesciences, Philips, Valcare Med Ltd, Vdyne, and W. L. Gore & Associates, Inc. Dr Naik has received consulting fees from Abbott, Boston Scientific, and Edwards Lifesciences. Dr Makkar has received grants and institutional support from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; has received consulting fees from Cordis Corporation and Medtronic; and has unpaid trial activities from Abbott, Boston Scientific, and Edwards Lifesciences. Dr Tadros has received consulting fees from Abbott and Edwards Lifesciences. Dr Price has received consulting fees and honoraria from Abbott, Alleviant, Boston Scientific, Biosense Webster, InnovHeart, Medtronic, Philips Medical, W.L. Gore & Associates, and Shockwave Medical. Dr Singh has served as a consultant and/or on the advisory board for Abbott Structural Heart, Boston Scientific, Siemens Healthcare, and Phillips. Dr Fam has received consulting fees from Abbott. Dr Kar has received consulting fees from Abbott, Boston Scientific, InterShunt, Medtronic, Peija, V wave, W.L. Gore, and Medtronic; and is co-principal investigator of EXPAND (Abbott) and co-principal investigator of REPAIR MR (Abbott). Dr Mehta has received research grants from Abbott and Edwards Lifesciences. Dr Bae has received consulting and speaker fees from Abbott; and is on the clinical endpoint committee and DSMB member for 4C Medical. Dr Makkar is a consultant for Abbott Vascular, Boston Scientific, Edwards Lifesciences, and GE Healthcare. Dr Benza has received consulting fees from Abbott and Bayer HealthCare Pharmaceuticals Inc; and performs consulting and is an endpoint review committee member for United Therapeutics. Dr Jorde has received consulting fees from Abbott and Edwards Lifesciences. Dr McCarthy is a co-principal investigator of Abbott’s REPAIR-MR study (unpaid); is on the advisory board for Abbott and egnite; receives royalties from Edwards Lifesciences; and has received speaker fees from Medtronic, Edwards Lifesciences, and Atricure. Dr Thourani has received research grants from and is an advisor for Edwards Lifesciences. Drs Ren and Trusty are employees of Abbott Structural Heart. Dr Sorajja is co-principal investigator for the TRILUMINATE Pivotal trial; serves on the advisory board for Anteris and VDyne; and has received consulting fees from Boston Scientific, Edwards Lifesciences, Evolution Medical, Medtronic, Shifamed, TriFlo, and W.L. Gore & Associates, Inc. Dr Adams is co-principal investigator for the TRILUMINATE Pivotal trial and receives royalties from Edward Lifesciences and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Severe tricuspid regurgitation (TR) often causes substantial impairment in patient-reported health status (ie, symptoms, physical and social function, and quality of life), which may improve with transcatheter tricuspid valve replacement (TTVR)., Objectives: The authors performed an in-depth analysis of health status of patients enrolled in the TRISCEND (Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel Device) II pivotal trial to help quantify the benefit of intervention to patients., Methods: The TRISCEND II pivotal trial randomized 400 patients with symptomatic and severe or greater TR 2:1 to TTVR with the EVOQUE tricuspid valve replacement system plus optimal medical therapy (OMT) or OMT alone. Health status was assessed with the Kansas City Cardiomyopathy Questionnaire and the 36-Item Short Form Health Survey. Changes in health status over 1 year were compared between treatment groups using mixed-effects repeated-measures models., Results: The analysis cohort included 392 patients, of whom 259 underwent attempted TTVR and 133 received OMT alone (mean age 79.2 ± 7.6 years, 75.5% women, 56.1% with massive or torrential TR). Patients had substantially impaired health status at baseline (mean Kansas City Cardiomyopathy Questionnaire Overall Summary Score [KCCQ-OS] 52.1 ± 22.8; mean 36-Item Short Form Health Survey physical component summary score 35.2 ± 8.4). TTVR+OMT patients reported significantly greater improvement in both disease-specific and generic health status at each follow-up time point. Mean between-group differences in the KCCQ-OS favored TTVR+OMT at each time point: 11.8 points (95% CI: 7.4-16.3 points) at 30 days, 20.8 points (95% CI: 16.1-25.5 points) at 6 months, and 17.8 points (95% CI: 13.0-22.5 points) at 1 year. In subgroup analyses, TTVR+OMT improved health status to a greater extent among patients with torrential or massive TR vs severe TR (treatment effect 23.3 vs 22.6 vs 11.3; interaction P = 0.049). At 1 year, 64.6% of TTVR+OMT patients were alive and well (KCCQ-OS ≥60 points and no decline of ≥10 points from baseline) compared with 31.0% with OMT alone., Conclusions: Compared with OMT alone, treatment of patients with symptomatic and severe or greater TR with TTVR+OMT resulted in substantial improvement in patients' symptoms, function, and quality of life. These benefits were evident 30 days after TTVR, continued to increase through 6 months, and remained durable through 1 year. (TRISCEND II Pivotal Trial [Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel Device]; NCT04482062)., Competing Interests: Funding Support and Author Disclosures The TRISCEND II pivotal trial and this analysis were funded by Edwards Lifesciences. Analyses were designed and conducted independently by the academic investigators. Dr Arnold has received research grants from the U.S. Food and Drug Administration and National Institutes of Health/National Heart, Lung, and Blood Institute. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic, Philips Healthcare, and Siemens Healthineers; has held institutional consulting contracts with no direct compensation with Abbott Structural, Anteris, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; and has served as the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry sponsored valve trials with no direct industry compensation. Dr Thourani has received research/advisor fees from Abbott Vascular, Artivion, CroíValve, Boston Scientific, and Edwards Lifesciences; has received research grants from Medtronic, Highlife, Innovalve, JenaValve, and HalfMoon; and owns equity in Dasi Simulation. Dr Makkar has received research grants from Edwards Lifesciences, Abbott Vascular, Boston Scientific, JenaValve, and Medtronic; and has received travel support from Edwards Lifesciences, JenaValve, Abbott Vascular, and Boston Scientific. Dr Makar has received consulting fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, GE Healthcare, and PiCardia. Dr Sharma has received consulting fees from Edwards Lifesciences. Dr Haeffele has received consulting fees from Edwards Lifesciences and Shifamed. Dr Davidson has served as an uncompensated advisor for and received research grant support from Edwards Lifesciences. Dr Narang has received speaker fees from Edwards Lifesciences, Abbott Laboratories, and Bristol Myers Squibb. Dr O’Neill has received consulting fees from Edwards Lifesciences. Dr Lee has received consulting fees from Edwards Lifesciences. Dr Yadav has received consulting and speaker fees from Edwards Lifesciences, Abbott Vascular, and Boston Scientific; has received advisory board honoraria from Dasi Simulations and Trisol; and owns equity in Dasi Simulations and Opus. Dr Zahr has received consulting fees, research grants, and educational grants from Edwards Lifesciences and Medtronic. Dr Chadderdon has received consulting fees from Edwards Lifesciences and Medtronic; and has received research funding from GE Healthcare and Siemens Healthineers. Dr Smith has received research grants from Edwards Lifesciences, Medtronic, and Artivion, which are managed through the Baylor Scott & White research institute; has received speaker fees from Edwards Lifesciences and Medtronic; and has received advisory board honoraria from Edwards Lifesciences and Enable CV. Dr Szerlip has received consulting fees from Edwards Lifesciences; has received speaker fees from Edwards Lifesciences, Cardiovascular Innovations, the Society for Cardiovascular Angiography and Interventions, and Boston Scientific; and has received advisory board honoraria from Abbott Vascular. Dr Whisenant has received consulting fees from Edwards Lifesciences and Abbott Vascular. Dr Garcia has received consulting and proctor fees from Edwards Lifesciences, Medtronic, Abbott Structural Heart, JC Medical, and Boston Scientific. Dr Grayburn has received research grants from Abbott Vascular, CardioValve, Cardiomech, Edwards Lifesciences, Medtronic, NeoChord, Restore Medical, and 4C Medical; and has received advisory board honoraria from Abbott Vascular, CardioValve, Edwards Lifesciences, Medtronic, and 4C Medical. Dr Sannino has received research grants from Edwards Lifesciences and Venus Medtech. Dr Mack has received consulting fees and research grants from Edwards Lifesciences. Dr Lurz has received institutional fees and research grants from Abbott Vascular, Edwards Lifesciences, and ReCor; has received honoraria from Edwards Lifesciences, Abbott Medical, Innoventric, ReCor, and Boehringer Ingelheim; and owns stock options in Innoventric. Dr Kodali has received consulting fees from Anteris, TriCares, X-Dot, MicroInterventional Devices, Supira, Adona, Tioga, Helix Valve Repair, Moray Medical, and Nyra; has received advisory board honoraria from Dura Biotech, Thubrikar Aortic Valve, Philips, Medtronic, Boston Scientific, and Abbott; and has received institutional research funding from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve. Dr Cohen has received research grants from the U.S. Food and Drug Administration, National Institutes of Health/National Heart, Lung, and Blood Institute, Edwards Lifesciences, Abbott, Boston Scientific, Medtronic, Philips, Corvia, Zoll Medical, and iRhythm; and has received consulting income from Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.)

Aortic regurgitation is the third most common valve lesion with increasing prevalence secondary to an ageing population. Transthoracic echocardiography plays a vital role in the identification and assessment of aortic regurgitation and proves essential in monitoring severity and determining the timing of intervention. Building on the foundations of previous British Society of Echocardiography (BSE) recommendations, this BSE guideline presents an update on how to approach an echocardiographic assessment of aortic regurgitation. It provides a practical, step-by-step guide to facilitate a comprehensive, high-quality echocardiographic assessment of aortic regurgitation. It discusses commonly encountered echocardiography-based challenges with suggestions regarding how this information is relevant in the interpretation and grading of regurgitation severity. Additionally, the value of other cardiac imaging modalities is discussed. The guideline concludes with an overview of aortic regurgitation in the clinical context, addressing chronic versus acute aortic regurgitation, which features prompt referral for intervention, and the consequences of combined valve disease., Competing Interests: Declarations. Ethics approval and consent to participate: Not applicable. Consent for publication: Not applicable. Competing interests: KV, LR, VT and DO are Editorial Board Members of the Echo Research and Practice Journal. VT is supported by an NIHR doctoral fellowship award (NIHR303306). RTH has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic, Philips Healthcare, Siemens Healthineers. This has not influenced their participation or any parts of the submitted manuscript., (© 2025. The Author(s).)

Background: Patients with tricuspid regurgitation (TR) frequently have transvalvular cardiac implantable electronic device (CIEDs)., Objectives: The aim of this study was to determine the safety and efficacy of tricuspid transcatheter edge-to-edge repair in patients with transvalvular CIED leads., Methods: The TRILUMINATE (Trial to Evaluate Cardiovascular Outcomes in Patients Treated With the Tricuspid Valve Repair System) Pivotal Trial (NCT03904147) is an international randomized, controlled trial in symptomatic subjects with severe TR. Subjects with CIED leads were screened by an eligibility committee prior to inclusion into the randomized or single-arm cohorts. Safety events were adjudicated by an independent review committee. All echocardiograms were analyzed by an independent core laboratory., Results: A total of 98 subjects (of 469) with attempted TriClip procedures had transvalvular CIED leads. CIED+ subjects were older (80.2 ± 8.6 years vs 78.2 ± 7.6 years; P = 0.02), with a higher prevalence of renal disease (46.9% vs 31.5%; P = 0.004) and lower health status (Kansas City Cardiomyopathy Questionnaire overall summary score 51.9 ± 21.0 vs 55.0 ± 23.1) at baseline compared with CIED- subjects. Slightly fewer clips were implanted in CIED+ subjects (mean 1.9) than in CIED- subjects (mean 2.2) (P = 0.0018). Procedural times were significantly shorter in CIED+ subjects (132.9 ± 63.3 minutes vs 155.9 ± 71.9 minutes; P = 0.0043) although greater in those with lead-induced TR (149.5 ± 87.5 minutes). Major adverse events (1.0% vs 1.1%) and major bleeding (3.1% vs 3.0%) were infrequent in CIED+ and CIED- subjects. At 30 days, TR reduction to moderate or less was similar in CIED+ and CIED- subjects (88% vs 87%) and was sustained out to 1 year in the majority of subjects (81% vs 84%). Compared with baseline, Kansas City Cardiomyopathy Questionnaire overall summary score significantly improved through 1 year in CIED+ subjects (18.7 ± 22.6; P < 0.0001) and CIED- subjects (16.8 ± 22.6; P < 0.0001). Heart failure symptoms were reduced in both groups at 30 days, with 85% of CIED+ subjects and 87% of CIED- subjects in NYHA functional class I or II. There were no differences in mortality, heart failure hospitalization, and need for tricuspid valve surgery or intervention between groups. No lead revisions, removals, or replacements were reported through follow-up., Conclusions: Tricuspid transcatheter edge-to-edge repair with the TriClip system was safe and effective in selected CIED+ subjects and did not affect CIED function. CIED+ subjects experienced similar TR reduction and quality-of-life improvements as CIED- subjects. Future work should define the treatable scope of patients with transvalvular CIED leads. (TRILUMINATE Pivotal Trial; NCT03904147)., Competing Interests: Funding Support and Author Disclosures This study was funded by Abbott (NCT03904147). Dr Naik has received consulting fees from Abbott, Boston Scientific, and Edwards Lifesciences. Dr Price has received consulting fees and honoraria from Abbott, Alleviant, Boston Scientific, Biosense Webster, InnovHeart, Medtronic, Philips Medical, W.L. Gore & Associates, and Shockwave Medical. Dr. Whisenant has received consulting fees from Abbott and Edwards Lifesciences. Dr Tadros has received consulting fees from Abbott and Edwards Lifesciences. Dr Makkar has received grants and institutional support from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; has received consulting fees from Cordis and Medtronic; and has conducted unpaid trial activities for Abbott, Boston Scientific, and Edwards Lifesciences. Dr Asgar is a consultant to Abbott Structural Heart, Medtronic, Edwards Lifesciences, W.L. Gore & Associates, and Anteris Technologies. Dr Fam has received consulting fees from Abbott. Dr Tang has received speaker’s honoraria from and has served as a physician proctor, a consultant, an advisory board member, a transcatheter aortic valve replacement publications committee member, an APOLLO trial screening committee member, and an IMPACT MR steering committee member for Medtronic; has received speaker honoraria from and served as a physician proctor, a consultant, an advisory board member, and at TRILUMINATE trial anatomical eligibility and publications committee member for Abbott Structural Heart; has served as an advisory board member for Boston Scientific and JenaValve; has served as a consultant and physician screening committee member for Shockwave Medical; has served as a consultant for NeoChord, Peija Medical, and Shenqi Medical Technology; and has received speaker honoraria from Siemens Healthineers. Dr Mehta has received research grants form Abbott and Edwards Lifesciences. Dr Byrne has received proctor fees and honoraria from Medtronic and Abbott. Dr Singh has served as a consultant and/or on the advisory board for Abbott Structural Heart, Boston Scientific, Siemens Healthcare, and Phillips. Dr Panaich is a consultant for Abbott, Edwards Lifesciences, and Boston Scientific. Ms Peterman and Dr Trusty are salaried employees of Abbott. Dr Hamid has received consulting fees from 4C Medical Technologies, Alleviant Medical, AMX, Anteris Technologies, Edwards Lifesciences, Philips, Valcare Med, V-Dyne, and W.L. Gore & Associates. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic, and Philips Healthcare; has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Anteris Technologies, Boston Scientific, Edwards Lifesciences, Medtronic, Novartis, and Philips Healthcare; and is chief scientific officer for the echocardiography core laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored valve trials, for which she receives no direct industry compensation. Dr Sorajja is co–principal investigator for the TRILUMINATE Pivotal Trial; serves on the advisory board for Anteris and V-Dyne; and has received consulting fees from Boston Scientific, Edwards Lifesciences, Evolution Medical, Medtronic, Shifamed, TriFlo, and W.L. Gore & Associates. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2025. Published by Elsevier Inc.)

Background: For patients with asymptomatic severe aortic stenosis and preserved left ventricular ejection fraction, current guidelines recommend routine clinical surveillance every 6 to 12 months. Data from randomized trials examining whether early intervention with transcatheter aortic-valve replacement (TAVR) will improve outcomes in these patients are lacking., Methods: At 75 centers in the United States and Canada, we randomly assigned, in a 1:1 ratio, patients with asymptomatic severe aortic stenosis to undergo early TAVR with transfemoral placement of a balloon-expandable valve or clinical surveillance. The primary end point was a composite of death, stroke, or unplanned hospitalization for cardiovascular causes. Superiority testing was performed in the intention-to-treat population., Results: A total of 901 patients underwent randomization; 455 patients were assigned to TAVR and 446 to clinical surveillance. The mean age of the patients was 75.8 years, the mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 1.8% (on a scale from 0 to 100%, with higher scores indicating a greater risk of death within 30 days after surgery), and 83.6% of patients were at low surgical risk. A primary end-point event occurred in 122 patients (26.8%) in the TAVR group and in 202 patients (45.3%) in the clinical surveillance group (hazard ratio, 0.50; 95% confidence interval, 0.40 to 0.63; P<0.001). Death occurred in 8.4% of the patients assigned to TAVR and in 9.2% of the patients assigned to clinical surveillance, stroke occurred in 4.2% and 6.7%, respectively, and unplanned hospitalization for cardiovascular causes occurred in 20.9% and 41.7%. During a median follow-up of 3.8 years, 87.0% of patients in the clinical surveillance group underwent aortic-valve replacement. There were no apparent differences in procedure-related adverse events between patients in the TAVR group and those in the clinical surveillance group who underwent aortic-valve replacement., Conclusions: Among patients with asymptomatic severe aortic stenosis, a strategy of early TAVR was superior to clinical surveillance in reducing the incidence of death, stroke, or unplanned hospitalization for cardiovascular causes. (Funded by Edwards Lifesciences; EARLY TAVR ClinicalTrials.gov number, NCT03042104.)., (Copyright © 2024 Massachusetts Medical Society.)

Background: Severe tricuspid regurgitation is associated with disabling symptoms and an increased risk of death. Data regarding outcomes after percutaneous transcatheter tricuspid-valve replacement are needed., Methods: In this international, multicenter trial, we randomly assigned 400 patients with severe symptomatic tricuspid regurgitation in a 2:1 ratio to undergo either transcatheter tricuspid-valve replacement and medical therapy (valve-replacement group) or medical therapy alone (control group). The hierarchical composite primary outcome was death from any cause, implantation of a right ventricular assist device or heart transplantation, postindex tricuspid-valve intervention, hospitalization for heart failure, an improvement of at least 10 points in the score on the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS), an improvement of at least one New York Heart Association (NYHA) functional class, and an improvement of at least 30 m on the 6-minute walk distance. A win ratio was calculated for the primary outcome by comparing all possible patient pairs, starting with the first event in the hierarchy., Results: A total of 267 patients were assigned to the valve-replacement group and 133 to the control group. At 1 year, the win ratio favoring valve replacement was 2.02 (95% confidence interval [CI], 1.56 to 2.62; P<0.001). In comparisons of patient pairs, those in the valve-replacement group had more wins than the control group with respect to death from any cause (14.8% vs. 12.5%), postindex tricuspid-valve intervention (3.2% vs. 0.6%), and improvement in the KCCQ-OS score (23.1% vs. 6.0%), NYHA class (10.2% vs. 0.8%), and 6-minute walk distance (1.1% vs. 0.9%). The valve-replacement group had fewer wins than the control group with respect to the annualized rate of hospitalization for heart failure (9.7% vs. 10.0%). Severe bleeding occurred in 15.4% of the valve-replacement group and in 5.3% of the control group (P = 0.003); new permanent pacemakers were implanted in 17.4% and 2.3%, respectively (P<0.001)., Conclusions: For patients with severe tricuspid regurgitation, transcatheter tricuspid-valve replacement was superior to medical therapy alone for the primary composite outcome, driven primarily by improvements in symptoms and quality of life. (Funded by Edwards Lifesciences; TRISCEND II ClinicalTrials.gov number, NCT04482062.)., (Copyright © 2024 Massachusetts Medical Society.)

Background: Two subtypes of atrial functional mitral regurgitation (AFMR) have been described, one is characterized by Carpentier type I and the other by Carpentier type IIIb leaflet motion., Objectives: The authors sought to analyze echocardiographic characteristics and outcomes of AFMR subtypes undergoing mitral valve transcatheter edge-to-edge repair (M-TEER)., Methods: Of 1,047 consecutive patients who underwent M-TEER, the authors identified those with isolated mitral annulus dilation (Carpentier I), termed AFMR-IAD, and those with atriogenic hamstringing characterized by restricted posterior mitral leaflet motion (Carpentier IIIb), termed AFMR-AH. Echocardiographic baseline characteristics and outcomes up to 1-year were analyzed., Results: A total of 128 patients (12.2%) met AFMR criteria; 75 (58.6%) were identified as AFMR-IAD and 53 (41.4%) as AFMR-AH. AFMR-AH displayed greater left atrial and left ventricular volumes, greater mitral annulus, shorter and steeper posterior mitral leaflet, and more pronounced MR (all P < 0.05). Technical success was achieved in 98.7% (AFMR-IAD) and 86.8% (AFMR-AH) of patients (P = 0.009). At discharge, device detachments were exclusively observed in AFMR-AH (10.0%). MR ≤II was achieved in 95.6% and 78.6% at 30 days (P = 0.009) and in 93.0% and 74.1% at 1 year (P = 0.038) in patients with AFMR-IAD and AFMR-AH, respectively. AFMR-AH was associated with procedural failure (OR: 1.17 [95% CI: 1.00-1.38]; P = 0.045) at 30 days (43.4% vs 24.0%; P = 0.023) and all-cause mortality (HR: 2.54 [95% CI: 1.09-5.91]; P = 0.031) at 1 year (77% vs 92%, Kaplan-Meier estimated 1-year survival; P = 0.017)., Conclusions: AFMR-AH shows worse procedural and clinical outcomes following M-TEER than AFMR-IAD. Thus, vigilance regarding this pathology is warranted and alternative mitral valve therapies might need to be considered., Competing Interests: Funding Support and Author Disclosures Dr J von Stein has received lecture fees from Edwards Lifesciences. Dr Körber has received travel support from JenaValve; and lecture fees from Edwards Lifesciences and Abbott. Dr Baldus has received consulting fees from Edwards Lifesciences. Dr Pfister has received speaker fees from Edwards Lifesciences and Abbott. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic, Philips Healthcare, and Siemens Healthineers; holds institutional consulting contracts, for which she receives no direct compensation, with Abbott Structural, Anteris, Edwards Lifesciences, Medtronic, and Novartis; and is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored valve trials, for which she receives no direct industry compensation. Dr Iliadis has received travel support and consulting fees from Abbott and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.)

3-dimensional (3D) intracardiac echocardiography (ICE) is emerging as a promising complement and potential alternative to transesophageal echocardiography for imaging guidance in structural heart interventions. To establish standardized practices, our multidisciplinary expert position statement serves as a comprehensive guide for the appropriate indications and utilization of 3D-ICE in various structural heart procedures. The paper covers essential aspects such as the fundamentals of 3D-ICE imaging, basic views, and workflow recommendations specifically tailored for ICE-guided structural heart procedures, such as transeptal puncture, device closure of intracardiac structures, and transcatheter mitral and tricuspid valve interventions. Current challenges, future directions, and training requirements to ensure operator proficiency are also discussed, thereby promoting the safety and efficacy of this innovative imaging modality to support expanding its future clinical applications., Competing Interests: Funding Support and Author Disclosures Dr Tang has received speaker honoraria and served as a physician proctor, consultant, advisory board member, transcatheter aortic valve replacement publications committee member, APOLLO (Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation) trial screening committee member, and IMPACT MR steering committee member for Medtronic; has received speaker honoraria and served as a physician proctor, consultant, advisory board member, and the TRILUMINATE (Trial to Evaluate Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation) anatomical eligibility and publications committee member for Abbott Structural Heart; has served as an advisory board member for Boston Scientific and Jena-Valve; has served as a consultant for NeoChord, Shockwave Medical, Peija Medical, and Shenqi Medical Technology; and has received speaker honoraria from Siemens Healthineers. Dr Hahn has received speaker fees from Abbott Vascular, Edwards Lifesciences, and Philips Healthcare; and has institutional consulting contracts (for which she has received no direct compensation) with Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis. Dr Alkhouli has served as a consultant to Boston Scientific and Abbott. Dr Aman has served on the advisory board for Abbott Structural Heart, as a consultant for Abbott Structural Heart and Philips, and on the speaker bureau for Abbott Structural Heart and Philips. Dr Berti has been a proctor for Abbott, St. Jude, and Edwards. Dr Chadderdon has received consulting fees from Medtronic and Edwards Lifesciences; and has received grant support from Medtronic and GE Healthcare. Dr Fam has been a consultant to Edwards Lifesciences, Abbott, and Cardiovalve. Dr Ho has served as a consultant for NeoChord. Dr Kliger has been a consultant and has received speaker honoraria from Edwards Lifesciences, Medtronic, and Siemens. Dr Kodali has received consultant fees from Admedus and Dura Biotech; holds equity in Dura Biotech, Microinterventional Devices, Thubrikar Aortic Valve, Supira, Admedus, TriFlo, and Anona; and has received institutional grant support from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve. Dr Latib has served on advisory boards or as a consultant for Medtronic, Boston Scientific, Edwards Lifesciences, Abbott, and VDyne. Dr Mahadevan has been a consultant for Edwards Lifesciences. Dr Nair has served as a consultant for and receives honoraria for speaking engagements from Boston Scientific, Johnson and Johnson, and Medtronic. Dr Packer has received research funding from Abbott, Biosense Webster, Boston Scientific/EPT, CardioInsight, EBAmed, Medtronic, NeuCures, Siemens, St. Jude Medical, Thermedical, National Institutes of Health, Robertson Foundation, Vital Project Funds, Xenter, and the Mr and Mrs J. Michael Cook Fund. Dr Praz has received travel expenses from Abbott Vascular, Edwards Lifesciences, and Polares Medical. Dr Rogers has been a consultant for Abbott Structural Heart and Boston Scientific. Dr Ruf has received speaker, consulting, and proctoring fees from Abbott Laboratories and Edwards Lifesciences. Dr Singh has been a consultant for Abbott Structural Heart and Philips. Dr van Mieghem has received research grant support from Abbott Vascular, Boston Scientific, Medtronic, Edwards Lifesciences, Biotronik, Daiichi Sankyo, Abiomed, and PulseCath BV. Dr Vannan has received research grants and speaker honoraria from Piedmont Heart Institute for Abbott, Medtronic, Edwards Lifesciences, Philips, Siemens Healthineers, and GE Healthcare. Dr Yadav has been a consultant and speaker for Edwards Lifesciences, Abbott, Dasi Simulations, and Shockwave Medical. Dr Zahr has received institutional grant support from Edwards Lifesciences and Medtronic. Dr von Bardeleben has been a consultant, advisory board member, TRILUMINATE trial eligibility committee member, and speaker for Abbott Vascular and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2025 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: Transcatheter tricuspid valve interventions (TTVI) are increasingly used to treat patients with significant tricuspid regurgitation (TR). The evolution of concurrent mitral regurgitation (MR) severity after TTVI is currently unknown and may be pivotal for clinical decision-making. The aim of this study was to assess the evolution of MR after TTVI and to identify predictors of MR worsening and improvement., Methods and Results: This analysis is a substudy of the TriValve Registry, an international registry designed to collect data on TTVI. This substudy included all patients with echocardiographic data on MR evolution and excluded those with a concomitant tricuspid and mitral transcatheter valve intervention or with a history of mitral valve intervention. The co-primary outcomes were MR improvement and worsening at two timepoints: pre-discharge and 2-month follow-up. This analysis included 359 patients with severe TR, mostly (80%) treated with tricuspid transcatheter edge-to-edge repair (T-TEER). MR improvement was found in 106 (29.5%) and 99 (34%) patients, while MR worsening was observed in 34 (9.5%) and 33 (11%) patients at pre-discharge and 2-month follow-up, respectively. Annuloplasty and heterotopic replacement were associated with MR worsening. Independent predictors of MR improvement were: atrial fibrillation, T-TEER, acute procedural success, TR reduction, left ventricular end-diastolic diameter> 60 mm, and beta-blocker therapy. Patients with moderate-to-severe/severe MR following TTVI showed significantly higher death rates., Conclusion: MR degree variation is common after TTVI, with most cases showing improvement. Clinical and procedural characteristics may predict the MR evolution, in particular procedural success and T-TEER play key roles in MR outcomes. TTVI may be beneficial, even in the presence of functional MR., Competing Interests: Conflict of interest: RH has served as a consultant for Abbott Vascular, Abbott Structural, NaviGate, Philips Healthcare, Medtronic, Edwards Lifesciences, and GE Healthcare; has been the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-supported trials, for which she receives no direct industry compensation; has received speaker fees from Boston Scientific and Baylis Medical; and has received non-financial support from 3mensio. HA has received consulting fees from Abbott and Edwards LifeSciences. MA has served as a proctor/consultant for and has received speaker fees from Abbott, Edwards LifeSciences, Boston, Zoll, and Medtronic; and has received institutional grants from Edwards Lifesciences, Abbott, Medtronic, and LSI Solutions. DB has received speaker honoraria and travel support from Abbott Vascular. KC has received honoraria from Abbott. PD has served as a consultant for Abbott Vascular, 4Tech, Neovasc, and InnovHeart; and has received honoraria from Abbott and Edwards Lifesciences. RE-L has received speaker fees from Abbott, Boston, and Edwards Lifesciences. JH has received speaker honoraria from Abbott Vascular and Edwards Lifesciences. DH has served as proctor for Edwards Lifesciences and Abbott Vascular. DK has received personal fees from Abbott Medical, Edwards Lifescienes, Medtronic Inc., and Pi-Cardio Ltd. outside the submitted work. MA has been a consultant to Abbott Structural Heart and Medtronic. AL has served on the advisory board for Medtronic, Abbott Vascular Boston Scientific, Edwards Lifesciences, Shifamed, NeoChord Inc., V-dyne, and Philips. EL has received grant support and lecture fees from Abbott; and has received lecture fees from Edwards Lifesciences. SL has received travel compensation from Edwards LifeSciences, advisory fees from Bayer, speaker honoraria from Abbott and serves as consultant for New Valve Technology. PL has received speaker fees from Abbott. FP has received travel expenses from Edwards Lifesciences, Abbott Vascular, and Polares Medical. JR-C has received institutional research grants from Edwards Lifesciences. JS has served as a consultant for Edwards Lifesciences. HS has received study honoraria, travel expenses, and consulting fees from 4Tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Bavaria Medizin Technologie, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, Celonova, Comed BV, Contego, CVRx, Edwards Lifesciences, Endologix, Hemoteq, Lifetech, Maquet Getinge Group, Medtronic, Mitralign, Nuomao Medtech, Occlutech, PFM Medical, ReCor, Renal Guard, Rox Medical, Terumo, Vascular Dynamics, and Vivasure Medical. GT has served as a consultant, physician advisory board member, and faculty trainer for Abbott Structural Heart; has served as a consultant for Medtronic and NeoChord; and has served as a physician advisory board member for JenaValve. K-PK has been a consultant to Edwards Lifesciences. MM has received the following personal fees of minimal amounts since January 2021: from Amgen, Liva Nova, and Vifor pharma as a member of Executive or Data Monitoring Committees of sponsored clinical trials; and from AstraZeneca, Bayer, Boehringer Ingelheim, Edwards Lifesciences, and Roche Diagnostics for participation to advisory boards and/or speeches at sponsored meetings. PL has been a consultant to Abbott Structural Heart, Edwards Lifesciences, and Medtronic. RSVB has performed unpaid trial activities for Abbott, Edwards Lifesciences, Medtronic, and the University of Göttingen (IIT) and serves as an advisory board or Speakers Bureau member for Abbott Cardiovascular, Edwards Lifesciences, Medtronic, and NeoChord. JW is a consultant for Edwards Lifesciences Inc. SW reports research, travel, or educational grants to the institution from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Corflow Therapeutics, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Janssen-Cilag, Johnson & Johnson, Medicure, Medtronic, Merck Sharp & Dohme, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pfizer, Polares, Regeneron, Aventis, Servier, Sinomed, Terumo, Vifor, and V-Wave. SW serves as an unpaid advisory board member and/or unpaid member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, Janssen, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, V-Wave, and Xeltis, but has not received personal payments by pharmaceutical companies or device manufacturers. He is also a member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. ML has received institutional clinical research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. RH has served as a consultant for Abbott Vascular, Abbott Structural, NaviGate, Philips Healthcare, Medtronic, Edwards Lifesciences, and GE Healthcare; has been the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-supported trials, for which she receives no direct industry compensation; has received speaker fees from Boston Scientific and Baylis Medical; and has received nonfinancial support from 3mensio. FM has served as a consultant for and received consulting fees and honoraria from Abbott Vascular, Edwards Lifesciences, Cardiovalve, SwissVortex, Perifect, Xeltis, Transseptal Solutions, Magenta, Valtech, and Medtronic; has reported being a cofounder of 4Tech; has received research grant support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific, NVT, and Terumo; has received royalties and owns intellectual property rights from Edwards Lifesciences (FMR surgical annuloplasty); and has reported being a shareholder in Cardiovalve, Swiss Vortex, Magenta, Transseptal Solutions, Occlufit, 4Tech, and Perifect. FDM is a consultant and has provided paid expert testimony for Abbott and Boston Scientific. MT has served as a consultant for Abbott Vascular, Boston Scientific, 4Tech, and CoreMedic and has received speaker honoraria from Edwards Lifesciences. SL has received travel compensation from Edwards Lifesciences. GP declares honorarium as speaker and/or institutional research grant from GE Healthcare, Bracco, Heartflow, Menarini, Novartis, Alexion, Novo Nordisk. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: The TRILUMINATE Pivotal trial is a prospective, randomized, controlled study of patients with severe tricuspid regurgitation (TR). Venous congestion due to TR may lead to end-organ dysfunction and failure. The potential to reverse or stop further deterioration in end-organ function is an important goal of treatment., Objectives: This study sought to examine changes in end-organ function after tricuspid transcatheter edge-to-edge repair (TEER) and assess the association of baseline end-organ function with heart failure (HF) hospitalizations and mortality., Methods: Subjects were randomized 1:1 to either the TEER group (TriClip System + medical therapy) or control group (medical therapy alone). Laboratory assessments and TR grading were performed at baseline and at all follow-up visits (discharge, 30 days, 6 months, and 12 months). An independent echocardiography core laboratory assessed TR severity and an independent clinical events committee adjudicated adverse events., Results: A total of 572 subjects were enrolled and randomized (285 TEER, 287 control patients). Patients with moderate-to-severe end-organ impairment (estimated glomerular ejection fraction [eGFR] <45 mL/min/1.73 m 2 or Model for End-Stage Liver Disease excluding INR [MELD-XI] >15) at baseline had increased incidence of HF hospitalization and death through 12 months, regardless of treatment. There were no statistically significant differences between TEER and control patients in eGFR or MELD-XI at 12 months. In subgroup analyses examining only successful TEER patients (moderate or less TR at discharge) compared with control patients, as well as when censoring patients with normal baseline values, both eGFR (+3.55 ± 1.04 mL/min/1.73 m 2 vs 0.07 ± 1.10 mL/min/1.73 m 2 ; P = 0.022) and MELD-XI (-0.52 ± 0.18 vs 0.34 ± 0.18; P = 0.0007) improved., Conclusions: Baseline end-organ function was associated with HF hospitalization and death in patients with severe TR. At 12 months, eGFR and MELD-XI scores were not statistically significantly different between the overall TEER and control groups. In patients who had successful TEER, statistically significant, yet small, favorable changes occurred for both eGFR and MELD-XI. Further investigation is needed to assess whether these changes in end-organ function after successful TEER are clinically meaningful and reduce HF hospitalization or death. (Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal [TRILUMINATE Pivotal]; NCT03904147)., Competing Interests: Funding Support and Author Disclosures The TRILUMINATE Pivotal trial was funded and sponsored by Abbott. Dr Jorde has received consulting fees from Abbott and Edwards Lifesciences. Dr Benza has received consulting fees from Abbott and Bayer HealthCare Pharmaceuticals Inc; and has been an endpoint review committee member for United Therapeutics. Dr McCarthy has been a coprincipal investigator of REPAIR-MR (unpaid) for Abbott; has served on advisory boards for Abbott and egnite; has received royalties from Edwards Lifesciences; and has received speaker fees from Medtronic, Edwards Lifesciences, and Atricure. Dr Ailawadi has received consulting fees from Abbott, Edwards Lifesciences, and Medtronic. Dr Whisenant has received consulting fees from Abbott and Edwards Lifesciences. Dr Makkar has received grants and institutional research support from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; has received consulting fees from Cordis Corporation and Medtronic; and has performed unpaid trial activities for Abbott, Boston Scientific, and Edwards Lifesciences. Dr Tadros has received consulting fees from Abbott and Edwards Lifesciences. Dr Naik has received consulting fees from Abbott, Boston Scientific, and Edwards Lifesciences. Dr Fam has received consulting fees from Abbott. Dr Sauer has received grants and institutional research support from Saint Luke’s Mid America Heart Institute, Bayer, CSL Vifor, Pfizer, Rivus, AstraZeneca, Novo Nordisk, Impulse Dynamics, 35Pharma, Abbott, Boston Scientific, General Prognostics, Acorai, Story Health, and Amgen; and has received honoraria for speaking or advising from Bayer, CSL Vifor, Abbott, Impulse Dynamics, Boston Scientific, Edwards Lifesciences, Acorai, Story Health, and General Prognostics. Dr Kar has received consulting fees from Abbott, Boston Scientific, InterShunt, Medtronic, Peija, V-Wave, W.L. Gore, and Medtronic; and has served as co-principal investigator of the EXPAND and REPAIR MR trials for Abbott. Dr von Bardeleben has performed unpaid trial activities for Abbott, Edwards Lifesciences, and University of Göttingen (IIT); and has served on advisory boards or speakers bureaus for Abbott, Bioventrix, Boston Scientific, Cardiac Dimensions, Edwards Lifesciences, and NeoChord. Dr Hahn has received speaker fees from Abbott, Baylis Medical Company Inc, Edwards Lifesciences, Medtronic, and Philips. Dr Hamid has received consulting fees from 4C Medical Technologies, Inc, Alleviant Medical, Inc, AMX, Anteris Technologies Corporation, Edwards Lifesciences, Philips, Valcare Med Ltd, VDyne, and W.L. Gore & Associates, Inc. Dr Zbinden has been a senior clinical scientist for Abbott. Dr Sorajja is co-principal investigator for the TRILUMINATE Pivotal trial; has served on advisory boards for Anteris Technologies and VDyne; and has received consulting fees from Boston Scientific, Edwards Lifesciences, Evolution Medical, Medtronic, Shifamed, TriFlo, and W.L. Gore & Associates, Inc. Dr Adams is co-principal investigator for the TRILUMINATE Pivotal trial; and receives royalties from Edward Lifesciences and Medtronic. Dr Murthy has reported that she has no relationships relevant to the contents of this paper to disclose., (Copyright © 2024. Published by Elsevier Inc.)

Background: Untreated severe tricuspid regurgitation (TR) carries a poor prognosis., Objectives: The authors report the 1-year outcomes of transcatheter edge-to-edge repair (TEER) with the TriClip system (Abbott Structural Heart) in patients with complex tricuspid valve anatomies., Methods: The multicenter, international TRILUMINATE Pivotal (Trial to Evaluate Cardiovascular Outcomes in Patients Treated with the Tricuspid Valve Repair System Pivotal) trial included a single-arm cohort, with complex tricuspid valve anatomies excluded from the randomized arm (ie, anticipated TR reduction but not to moderate or less after TEER). The primary outcome endpoint of the single arm was 1-year survival with a Kansas City Cardiomyopathy Questionnaire score improvement ≥10 points., Results: In the primary analysis population (N = 100), the mean age was 80 ± 6 years, and 35% had a cardiac implantable electronic device lead. Nearly 90% of patients had massive or torrential TR, 44% had prior left-sided valve interventions, 63% had ≥4-segmental tricuspid leaflet morphology, and the coaptation gap averaged 7.4 ± 2.7 mm. The primary endpoint was met (outcome: 46.2%, performance goal: 30%; P = 0.0008). A total of 81% of subjects had moderate or less TR at 1 year. No major adverse events or deaths occurred within 30 days postprocedure. One-year all-cause mortality and heart failure hospitalization were 15% and 24%, respectively. Significant improvements in NYHA functional class and Kansas City Cardiomyopathy Questionnaire overall scores occurred and were maintained at 1 year., Conclusions: In patients with complex tricuspid anatomies, TEER with the TriClip system demonstrated excellent procedural safety with significant TR reduction and associated improvements in quality of life at 1 year., Competing Interests: Funding Support and Author Disclosures The TRILUMINATE Pivotal study is sponsored by Abbott. Dr Adams serves as the national co–principal investigator for the Abbott TRILUMINATE U.S. Pivotal Trial, the Medtronic APOLLO FDA Pivotal Trial, and the CoreValve U.S. Pivotal Trial; and The Icahn School of Medicine at Mount Sinai receives royalty payments from Edwards Lifesciences and Medtronic for intellectual property related to the development of valve repair rings. Dr Tang has received consultant and/or speaker honoraria from Abbott Vascular, EastEnd Medical, Medtronic USA, Inc, NeoChord, and Siemens; and serves as a physician advisory board member for JenaValve. Dr Whisenant has received consultant honoraria from Abbott Vascular and Edwards Lifesciences. Dr Kodali has received consultant honoraria from Abbott Vascular, Claret Medical, and Merrill LifeScience; and serves as an advisory board member for Biotrace Medical, MID, and Thubrikar Aortic Valve Inc. Dr Singh has received consultant honoraria from Abbott Vascular. Dr Fam has received consultant honoraria from Abbott Canada, Edwards Lifesciences, and Venus MedTech. Dr Kar serves as the national co–principal investigator of the REPAIR-MR trial; serves a member of the TRILUMINATE Steering Committee; has received consultant honoraria from Abbott Vascular, Boston Scientific, InterShunt, Medtronic USA Inc, Peija, V wave, W. L. Gore & Associates Inc; and is an executive committee member for the V wave trial. Dr Price has received reimbursement from Scripps Health for patient enrollment; and has received consultant honoraria from Abbott Vascular, Biotronik Inc, Boston Scientific, Medtronic, Philips, ShockWave Medical Inc, and W. L. Gore & Associates Inc. Dr Schwartz has received consultant honoraria from Abbott Vascular, Boston Scientific, Cordis, Edwards Lifesciences, Medtronic USA Inc, and Philips Electronics North America. Dr Makkar has received consultant honoraria and/or travel support from Abbott Vascular, Boston Scientific, Cordis Corporation, Edwards Lifesciences, and Medtronic USA Inc; and serves as the VP of Cardiovascular Innovation and Intervention and the Director of Interventional Cardiology and Cardiac Cath Lab at Cedars-Sinai Medical Center. Dr Tadros has received consultant honoraria from Edwards Lifesciences. Dr Asgar has received consulting honoraria from Abbott, Medtronic, Edwards Lifesciences, Teleflex, and W. L. Gore & Associates Inc. Dr Jorde has received consultant honoraria from Abbott and Edwards Lifesciences. Dr Benza has received consultant honoraria from Abbott, Bayer HealthCare Pharmaceuticals Inc, and United Therapeutics. Dr Thourani has received consultant honoraria from Abbott Vascular; and serves as an advisor or researcher for Artivion, AtriCure, Abbott Vascular, Boston Scientific, Edwards Lifesciences, JenaValve, and Shockwave. Dr McCarthy has received royalties and speaker fees from Edwards Lifesciences; and serves on the advisory board and as an unpaid principal investigator for Abbott Laboratories. Dr Bae has received consulting/speaker honoraria from Abbott Structural. Dr Smith serves as a consultant for Abbot Vascular, Laminar, Novo Nordisk, and W. L. Gore & Associates Inc. Dr Lim has received consultant fees/honoraria from Ancora, Dinova Medtech, Valgen, Venus, W. L. Gore & Associates Inc; and is a co-investigator in Abbott COAPT, REPAIR-MR and TRILUMINATE, Edwards CLASP IID/F, and Medtronic APOLLO clinical trials. Dr Makar has received consultant honoraria from Abbott Vascular and Boston Scientific. Dr Naik has received consultant honoraria from Abbott Laboratories, Boston Scientific, and Edwards Lifesciences. Dr Latib serves as a consultant and/or advisory board member for Abbott, Medtronic, Boston Scientific, Edwards Lifesciences, Shifamed, NeoChord, Philips, and VDyne. Dr Sitges has received speaker honoraria and consultant fees for Abbott, Edwards Lifesciences, Medtronic, General Electric, and Siemens. Dr von Bardeleben has performed nonpaid trial activities for Abbott, Edwards Lifesciences, Medtronic, Heart Valve Society (unpaid), EU SHD Coalition (unpaid), and the University of Göttingen (IIT); and serves as an advisory board member or Speakers Bureau member for Abbott Cardiovascular, Edwards Lifesciences, Medtronic, and NeoChord. Dr Lurz has received institutional grants from Abbott Vascular (for patient recruitment), Edwards Lifesciences, and ReCor; has received honoraria from Edwards Lifesciences, Abbott Medical, Innoventric, ReCor, and Boehringer Ingelheim; and has stock options with Innoventric. Dr Hamid has received consultant honoraria from 4C Medical Technologies, Inc, Alleviant Medical Inc, AMX, Anteris Technologies Corporation, Edwards Lifesciences, Philips, Valcare Med Ltd, Vdyne, and W. L. Gore & Associates Inc. Dr Hahn has received speaker honoraria from Abbott Vascular, Baylis Medical Company Inc, Edwards Lifesciences, Medtronic USA Inc, and Philips; and serves as Director of Interventional Echocardiography at Columbia University. Dr Sorajja serves as the national co–principal investigator for the Abbott Triluminate US Clinical trial and the clinical trial principal investigator for HighLife; has received consultant honoraria from Boston Scientific, Edwards Lifesciences, Evolution Medical, Medtronic, Shifamed, TriFlo, and W. L. Gore & Associates Inc; and is an advisory board member for Anteris and VDyne., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Tricuspid regurgitation (TR), an underrecognized disease, overlooked by clinicians for many years due to its assumed benign nature. Recent epidemiological studies suggest significant TR may be seen in up to 6% of elderly patients. An increase in prevalence is expected due to the higher incidence of various clinical predictors of TR progression. Increasing severity of TR is associated with worse outcomes with a novel morphologic classification providing a more refined prediction of outcomes. Advances in cardiac imaging, particularly echocardiography, are integral to the diagnosis of disease severity which not only includes quantitation of TR, but also an assessment of the right atrium, right ventricle and pulmonary arterial circulation. Once identified and quantified, TR management requires a multi-disciplinary heart team management including structural imagers, heart failure specialists, electrophysiologist, cardiac surgeons and interventionalists. Data to support medical therapies are lacking although guidelines support the management of congestive signs and symptoms, as well as comorbidities such as left heart failure and rhythm management. The risks of surgical interventions are slowly improving, however, transcatheter therapies are now available to treat patients with high surgical risk. This manuscript will provide a state-of-art review of this fast-moving field, including current scientific evidences, but also upcoming perspectives with multiple ongoing clinical studies.

Background: Surgery remains an important treatment for low-risk patients with severe symptomatic aortic stenosis (AS). This study evaluated 5-year outcomes in low-risk patients undergoing isolated surgical aortic valve replacement (SAVR) or SAVR with concomitant procedures within the randomized Placement of Aortic Transcatheter Valves (PARTNER) 3 trial., Methods: In the PARTNER 3 trial, 454 patients underwent surgery for severe, symptomatic, trileaflet AS and were followed up for 5 years. Patients were stratified into those undergoing isolated SAVR (n = 334; 73.6%) vs concomitant SAVR (n = 120; 26.4%). Short- and long-term morbidity was adjudicated by a Clinical Events Committee. Hemodynamic valve performance was evaluated by an echocardiographic core laboratory. Patient-reported health status was measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ)., Results: The mean age of participants was 73.6 ± 6.1 years; 71.1% of these patients were male. The median SAVR implant size was 23 mm overall. Five-year all-cause mortality (with vital status sweep) was 9.0% for all patients (8.5% isolated SAVR; 10.2% concomitant SAVR; P = .58), comparable to a recent analysis of low-risk isolated SAVR-treated patients in the STS database (overall mortality, 7.1%). The average 5-year mean gradient was 11.7 ± 5.6 mm Hg overall. Reintervention rates were low in both groups (isolated SAVR, 2.3% vs concomitant SAVR, 5.0%; P = .21), and most patients (isolated SAVR, 87.9%; concomitant SAVR, 86.1%) were alive with no evidence of bioprosthetic valve failure at 5 years., Conclusions: SAVR in low-risk patients in the PARTNER 3 trial demonstrated excellent 5-year outcomes. Five-year mortality was similar in patients undergoing isolated SAVR vs concomitant SAVR. This result was comparable to recently published national SAVR outcomes, thus demonstrating the generalizability of these findings., Competing Interests: Disclosures Vinod H. Thourani reports a relationship with Abbott Vascular that includes: consulting or advisory; with AtriCure that includes: consulting or advisory; with Artivion that includes: consulting or advisory; with Boston Scientific that includes: consulting or advisory; with Edwards Lifesciences that includes: consulting or advisory; with Medtronic that includes: consulting or advisory; with JenaValve Technology that includes: consulting or advisory; with Highlife that includes: consulting or advisory; with Croivalve that includes: consulting or advisory; and with Dasi Simulations that includes: equity or stocks. Martin B. Leon reports a relationship with W.L. Gore & Associates Medical Products Division that includes: consulting or advisory; with Meril Life Sciences that includes: consulting or advisory; with Medtronic that includes: consulting or advisory; with Boston Scientific that includes: consulting or advisory; and with Abbott that includes: consulting or advisory. Raj Makkar reports a relationship with Cordis that includes: consulting or advisory; and with Medtronic that includes: consulting or advisory. Wilson Y. Szeto reports a relationship with Terumo Interventional Systems that includes: consulting or advisory; with MicroInterventional Devices that includes: consulting or advisory; and with Cardiac Dimensions that includes: consulting or advisory. Susheel K. Kodali reports a relationship with Philips that includes: consulting or advisory; with Admedus that includes: consulting or advisory and equity or stocks; with TriCares that includes: consulting or advisory; with Dura Biotech that includes: consulting or advisory and equity or stocks; with Thubrikar Aortic Valve that includes: equity or stocks; with MicroInterventional Devices that includes: equity or stocks; with Supira that includes: equity or stocks; with TriFlo that includes: equity or stocks; with Adona that includes: equity or stocks; and with Tioga that includes: equity or stocks. Rebecca T. Hahn reports a relationship with Abbott that includes: speaking and lecture fees; with Baylis Medical Company that includes: speaking and lecture fees; with Edwards Lifesciences that includes: speaking and lecture fees; with Medtronic that includes: speaking and lecture fees; with Philips that includes: speaking and lecture fees; and with Siemens that includes: speaking and lecture fees. S. Chris Malaisrie reports a relationship with Medtronic that includes: funding grants; with Edwards Lifesciences that includes: consulting or advisory; with Terumo Interventional Systems that includes: consulting or advisory; and with Artivion that includes: consulting or advisory. Howard C. Herrmann reports a relationship with Abbott that includes: consulting or advisory; with Edwards Lifesciences that includes: consulting or advisory; with Medtronic that includes: consulting or advisory; with Johnson & Johnson that includes: consulting or advisory; with Prolifagen that includes: consulting or advisory; and with MicroInterventional Devices that includes: equity or stocks. Vasilis Babaliaros reports a relationship with Edwards Lifesciences that includes: consulting or advisory; and with Transmural Systems that includes: equity or stocks. Philippe Genereux reports a relationship with Abbott that includes: consulting or advisory; with AbioMed that includes: consulting or advisory; with Boston Scientific that includes: consulting or advisory; with Caranx Medical that includes: consulting or advisory; with Cardiovascular Systems that includes: consulting or advisory; with Edwards Lifesciences that includes: consulting or advisory; with Egnite that includes: consulting or advisory; with GE Healthcare that includes: consulting or advisory; with iRhythm Technologies that includes: consulting or advisory; with Medtronic that includes: consulting or advisory; with Shockwave Medical that includes: consulting or advisory; with Siemens that includes: consulting or advisory; with Teleflex that includes: consulting or advisory; with 4C Medical Technologies that includes: consulting or advisory; with Pi-Cardia that includes: equity or stocks; with Puzzle Medical that includes: equity or stocks; with Soundbite Medical that includes: equity or stocks; and with Saranas that includes: equity or stocks. David J. Cohen reports a relationship with Abbott that includes: consulting or advisory; with Boston Scientific that includes: consulting or advisory; and with Edwards Lifesciences that includes: consulting or advisory; and with Elixir Medical that includes: consulting or advisory. Molly Szerlip reports a relationship with Edwards Lifesciences that includes: consulting or advisory; with Boston Scientific that includes: consulting or advisory; and with Abbott that includes: consulting or advisory. Julien Ternacle reports a relationship with Edwards Lifesciences that includes: consulting or advisory; with Abbott that includes: consulting or advisory; with GE Medical that includes: consulting or advisory; and with Philips that includes: consulting or advisory. Jonathon Leipsic reports a relationship with HeartFlow Inc that includes: consulting or advisory; and with Circle CVI that includes: consulting or advisory. Philipp Blanke reports a relationship with Edwards Lifesciences that includes: consulting or advisory; and with Laralab that includes: consulting or advisory. John G. Webb reports a relationship with Edwards Lifesciences that includes: consulting or advisory., (Copyright © 2025 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

This case report describes a patient diagnosed with severe secondary tricuspid regurgitation (TR) and pulmonary hypertension. Initial improvement with heart failure therapy was followed by a worsening of TR despite optimal medical management. Transcatheter edge-to-edge repair successfully addressed TR, resulting in marked clinical improvement., Competing Interests: Dr Bartkowiak has received a research grant from Novartis Foundation. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic, and Philips Healthcare; has institutional consulting contracts for which she has received no direct compensation with Abbott Structural, Edwards Lifesciences, Medtronic, and Novartis; and is the chief scientific officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored tricuspid valve trials, for which she receives no direct industry compensation., (© 2024 The Authors.)

Background: Neurohormonal modulation and afterload reduction are key for treatment of heart failure with reduced ejection fraction (HFrEF). In HFrEF patients with concomitant moderate aortic stenosis (AS), treatment with transcatheter aortic valve replacement (TAVR) may be complementary to guideline-directed medical therapy (GDMT)., Objectives: This study sought to determine whether TAVR for moderate AS provides clinical benefit in patients with HFrEF on top of GDMT., Methods: We performed an investigator-initiated, international, randomized controlled trial in patients with HFrEF on GDMT with moderate AS who were suitable for transfemoral TAVR with a balloon-expandable valve. Patients were randomized 1:1 to TAVR or clinical aortic stenosis surveillance (CASS) with aortic valve replacement upon progression to severe AS. The primary endpoint was the hierarchical occurrence of: 1) all-cause death; 2) disabling stroke; 3) disease-related hospitalizations and heart failure equivalents; and 4) change from baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score analyzed using the win ratio., Results: From January 2017 to December 2022, 178 patients were randomized to TAVR (n = 89) or AS surveillance (n = 89). The mean age was 77 years, 20.8% were female, and 55.6% were in NYHA functional class III or IV. The median follow-up duration was 23 months (Q1-Q3: 12-33 months). A total of 38 (43%) patients in the CASS group (of whom 35 had progressed to severe AS) underwent TAVR at a median of 12 months postrandomization. TAVR was associated with wins in 47.6% of pairs, compared with 36.6% in the CASS group, resulting in a win ratio of 1.31 (95% CI: 0.91-1.88; P = 0.14). At 1 year, TAVR resulted in a greater improvement in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score compared with the CASS group (12.8 ± 21.9 points vs 3.2 ± 22.8 points; P = 0.018)., Conclusions: TAVR was not superior to AS surveillance for the primary hierarchical composite endpoint in patients with moderate AS and HFrEF on GDMT. Preemptive TAVR for moderate AS was safe and may provide clinically meaningful quality-of-life benefits., Competing Interests: Funding Support and Author Disclosures The TAVR UNLOAD trial was funded by an investigator-initiated grant from Edwards Lifesciences. The funder had no role in the study design, data collection or management, or the statistical analyses. The principal investigators had unrestricted access to the study data, wrote the manuscript, and vouched for the accuracy and completeness of the data and for the fidelity of the trial to the protocol. All the authors reviewed and approved the manuscript. Dr Van Mieghem has received grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic; and has received advisory fees from Abbott, Boston Scientific, Pulse Cath BV, and Medtronic. Dr Elmariah has received research grants from Edwards Lifesciences and Medtronic; and has received consulting fees from Edwards Lifesciences. Dr Spitzer has held institutional contracts/grants for which he receives no direct compensation from Abbott, Biosensors Europe SA, Boston Scientific, Edwards Lifesciences, Medtronic, Mixin Medtech (Suzhou), Shanghai Microport Medical, NVT GmbH, Philips Healthcare, Pie Medical Imaging, Shanghai Shenqi Medical Technologies, and Siemens Healthcare GmbH. Dr Pibarot has received funding from Edwards Lifesciences, Pi-Cardia, and Cardiac Success for echocardiography core laboratory analyses in the field of transcatheter valve therapies and Medtronic for in vitro analyses, with no personal compensation. Dr Nazif has received consulting fees or honoraria from Medtronic, Boston Scientific, Teleflex, Encompass Technologies, and Opsens Medical; and has received institutional research grants from Edwards Lifesciences, Boston Scientific, Medtronic, and Abbott. Dr Bax has received speaker fees from Abbott and Edwards Lifesciences. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic, Philips Healthcare, and Siemens Healthineers; has held institutional consulting contracts for which she receives no direct compensation from Abbott Structural, Edwards Lifesciences, Medtronic, and Novartis; and is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored tricuspid valve trials, for which she receives no direct industry compensation. Dr Popma’s spouse is a Medtronic employee. Dr Ben-Yehuda has received consulting fees from Edwards Lifesciences, Medtronic, Cardiovalve, and Bioventrix. Dr Redfors has received consulting fees from Pfizer and Boehringer Ingelheim. Dr Kodali has received grant support, paid to his institution, from Medtronic, Boston Scientific, and Abbott Vascular; has received consulting fees from Abbott Vascular, Claret Medical, Admedus, and Meril Life Sciences; and holds equity options in BioTrace Medical, Dura Biotech, and Thubrikar Aortic Valve. Dr Hermanides has received lecture fees from Abbott Vascular, Amgen, and Novartis. Dr Cohen has received research grant support from Edwards Lifesciences, Abbott, Boston Scientific, Corvia Medical, Philips, Brain-Q, Saranas, Zoll Medical, CathWorks, and ANCORA; and has received consulting fees from Medtronic, Edwards Lifesciences, Abbott, Boston Scientific, Corvia Medical, Impulse Dynamics, AngioInsight, and HeartBeam. Dr Leon has received institutional clinical research grants from Abbott, Boston Scientific, Edwards, and Medtronic. 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: New postprocessing software facilitates 3-dimensional (3D) echocardiographic determination of mitral annular (MA) and neo-left ventricular outflow tract (neo-LVOT) dimensions in patients undergoing transcatheter mitral valve replacement (TMVR)., Objectives: This study aims to test the accuracy of 3D echocardiographic analysis as compared to baseline computed tomography (CT)., Methods: A total of 105 consecutive patients who underwent TMVR at 2 tertiary care centers between October 2017 and May 2023 were retrospectively included. A virtual valve was projected in both baseline CT and 3D transesophageal echocardiography (TEE) using dedicated software. MA dimensions were measured in baseline images and neo-LVOT dimensions were measured in baseline and postprocedural images. All measurements were compared to baseline CT as a reference. The predicted neo-LVOT area was correlated with postprocedural peak LVOT gradients., Results: There was no significant bias in baseline neo-LVOT prediction between both imaging modalities. TEE significantly underestimated MA area, perimeter, and medial-lateral dimension compared to CT. Both modalities significantly underestimated the actual neo-LVOT area (mean bias pre/post TEE: 25.6 mm 2 , limit of agreement: -92.2 mm 2 to 143.3 mm 2 ; P < 0.001; mean bias pre/post CT: 28.3 mm 2 , limit of agreement: -65.8 mm 2 to 122.4 mm 2 ; P = 0.046), driven by neo-LVOT underestimation in the group treated with dedicated mitral valve bioprosthesis. Both CT- and TEE-predicted-neo-LVOT areas exhibited an inverse correlation with postprocedural LVOT gradients (r 2  = 0.481; P < 0.001 for TEE and r 2  = 0.401; P < 0.001 for CT)., Conclusions: TEE-derived analysis provides comparable results with CT-derived metrics in predicting the neo-LVOT area and peak gradient after TMVR., Competing Interests: Funding Support and Author Disclosures Dr Bartkowiak has received grants from Novartis Foundation. Dr Windecker has received grants to the institution without personal remuneration from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Braun, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Cordis Medical, Corflow Therapeutics, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Farapulse Inc, Fumedica, Guerbet, Idorsia, Inari Medical, InfraRedx, Janssen-Cilag, Johnson and Johnson, Medalliance, Medicure, Medtronic, Merck Sharp and Dohm, Miracor Medical, MonarQ, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pharming Tech, Pfizer, Polares, Regeneron, Sanofi-Aventis, Servier, Sinomed, Terumo, Vifor, and V-Wave; has served as advisory board member and/or member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, and V-Wave with payments to the institution but no personal payments; and has been a member of a steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. Dr George has received consulting fees from Zimmer Biomet, Atricure, Neosurgery, Neptune Medical, Abbvie, Johnson and Johnson, Durvena, Boston Scientific, Edwards Lifesciences, Medtronic, Help-TheraX, 3ive, Encompass, Summus Medical, Abbott SJM, BCI, and Xeltis; has been on advisory boards for Edwards Surgical, Medtronic Surgical, Medtronic Structural Mitral and Tricuspid, Trisol Medical, Valcare Medical, Durvena, Abbvie, Johnson and Johnson, Foldax Medical, Zimmer Biomet, Neosurgery, Abbvie, Boston Scientific, Summus Medical, BCI Equity: Valcare Medical, Durvena, CardioMech, Vdyne, MitreMedical, MITRx, and BCI; and has received institutional funding to Columbia University from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve. Dr Kodali has received institutional grants from Edwards Lifesciences, Medtronic, and Abbott; has received consulting fees from Abbott, Admedus, and Meril Lifesciences; and has equity options from Biotrace Medical and Thubrikar Aortic Valve Inc. Dr Praz has been compensated for travel expenses from Edwards Lifescicences, Abbott Vascular, Medira, Polares Medical, and Siemens Healthineers. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic, and Philips Healthcare; has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Edwards Lifesciences, Medtronic, and Novartis; and the is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored tricuspid valve trials for which she receives no direct industry compensation. 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.)

With the recent approval of the transcatheter EVOQUE tricuspid valve replacement system to treat severe, symptomatic tricuspid regurgitation, there is a need to define the appropriate patient population and anatomical considerations for this device. In this consensus document, the authors review these considerations, describe the procedural steps and imaging requirements to ensure technical success, and discuss management of complex intraprocedural circumstances., Competing Interests: Funding Support and Author Disclosures Dr Hahn has received speaker fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Philips Healthcare, and Siemens Healthineers; and 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 Makkar has received research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Makkar is a consultant for Abbott Vascular, Boston Scientific, Edwards Lifesciences, GE Healthcare. Dr Davidson has received research grant support from Edwards Lifesciences, Abbott Vascular; is an advisor for Philips Healthcare; and is an uncompensated advisor for Edwards Lifesciences. Dr Puthamana has received speaker honoraria from Edwards Lifesciences and Abbott Structural; and has received consultant fees from Edwards Lifesciences. Dr Zahr has received consulting, research, and educational grants from Edwards Lifesciences, Medtronic, and Philips. Dr Chadderdon is a consultant to Edwards Lifesciences, Medtronic, and Phillips Healthcare. Dr Fam is a consultant to Edwards Lifesciences, Abbott, Medtronic, and Cardiovalve. Dr Ong has received speaker honoraria and consultant fees from Abbott Vascular and Edwards Lifesciences. Dr Yadav has received consultant and speaker fees from Edwards Lifesciences, Abbott, and Boston Scientific; is an advisory board member for and has stock options in Dasi Simulations; has received institutional research funding from Edwards Lifesciences, Abbott Vascular, Medtronic, Boston Scientific, Innovalve, JenaValve, HighLife, Trisol, and CroiValve. Dr Thourani has received research grants from and is an advisor for Edwards Lifesciences. Dr Vannan has received institutional research grants and equipment support from Siemens Healthineers, Philips, GE Healthcare; and has received institutional speaker honoraria from Siemens, Philips, Abbott, and Medtronic (no direct industry compensation). Dr Tchétché has received consulting fees from Edwards Lifesciences. Dr Dumonteil is a consultant for Abbott, Ancora Heart, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Smith has received institutional research grants from Edwards Lifesciences, Medtronic, NeoChord, and Artivion; has received speaker honoraria from Medtronic and Edwards Lifesciences; and is on the advisory board of Edwards Lifesciences. Dr Grayburn has received research grants from Abbott Vascular, Boston Scientific, Cardiovalve, Cardiomech, Edwards Lifesciences, Medtronic, NeoChord, Restore Medical, and 4C Medical; and has received consulting and advisory board fees from Abbott Vascular, Edwards Lifesciences, Medtronic, and 4C Medical. Dr Webb has received research grants from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific; and is a consultant to Edwards Lifesciences. Dr Moss is a consultant to Edwards Lifesciences; and has received speaker fees and travel support from Edwards Lifesciences, Abbott, Medtronic, Boston Scientific. Dr Windecker has received research, travel, or educational grants to the institution without personal remuneration from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, B. Braun, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, Cardiovalve, Cordis Medical, Corflow Therapeutics, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Farapulse, Fumedica, Guerbet, Idorsia, Inari Medical, Infraredx, Janssen-Cilag, Johnson & Johnson, MedAlliance, Medicure, Medtronic, Merck Sharp & Dohme, Miracor Medical, MonarQ, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pharming Tech, Pfizer, Polares, Regeneron, Sanofi, Servier, Sinomed, Terumo, Vifor, and V-Wave; has served as an advisory board member and/or member of the steering or executive groups of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, and V-Wave with payments to the institution but no personal payments; and is a member of the steering or executive committee group of several investigator-initiated trials that receive funding from industry without impact on his personal remuneration. Dr Nabauer has received consultant and speaker fees from Edwards Lifesciences and Abbott Vascular. Dr Hausleiter is a consultant to Edwards Lifesciences; and has received research funding and speaker honoraria from Edwards Lifesciences. Dr Kodali is a consultant for Admedus, TriCares, TriFlo, X-Dot, Micro-Interventional Devices, Supira, Adona, Tioga, Helix Valve Repair, and Moray Medical; has served as an advisory board member for Dura, Biotech, Thubrikar Aortic Valve, Philips, Medtronic, and Boston Scientific; and has received institutional grant support from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve. 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: Transcatheter tricuspid valve intervention (TTVI) has been increasingly adopted in recent years for the treatment of patients with tricuspid regurgitation (TR). However, no dedicated risk stratification has been established for patients undergoing TTVI., Objectives: The aim of the present study was to propose a dedicated risk score for patients affected by severe TR undergoing TTVI., Methods: The score was derived from the TRIVALVE (International Multisite Transcatheter Tricuspid Valve Therapies Registry; NCT03416166) registry, according to data availability. A stepwise model approach was used on predictor variables to develop a scoring system for predicting 12-month mortality or rehospitalization using multivariable logistic regression. Internal discrimination, calibration, and validation were assessed using receiver-operating characteristic curve analysis and bootstrapping with 1,000 resamples., Results: A total of 483 patients were included in the study, with an overall 12-month mortality or rehospitalization rate of 19% (n = 94). The final risk score, ranging from 0 to 4.5, included the following 5 parameters (adjusted for age and gender): 1) atrial fibrillation at baseline; 2) glomerular filtration rate <30 mL/min; 3) elevated gamma-glutamyl transferase/bilirubin levels; 4) signs of right heart failure; and 5) left ventricular ejection fraction <50%. The bias-corrected area under the receiver-operating characteristic curve was 68% (95% CI: 62%-75%). A cutoff value of 2.5 demonstrated sensitivity of 65.4% and specificity of 60.5% for the outcome., Conclusions: The present study proposes a dedicated risk score for patients undergoing TTVI, providing an additional and simple tool for heart teams to select the best therapy for patients affected by severe TR., Competing Interests: Funding Support and Author Disclosures Dr Russo has received a fellowship training grant from the European Association of Percutaneous Cardiovascular Interventions, sponsored by Edwards Lifesciences. Dr Adamo has received personal fees from Abbott Vascular, Medtronic, and Novartis. 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; has stock options with NaviGate; and 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 Andreas is a proctor, consultant, and speaker for Edwards Lifesciences, Abbott, Medtronic, Boston Scientific, and Zoll; and has received institutional research grants from Edwards Lifesciences, Abbott, Medtronic, and LSI Solutions. Dr Denti has received speaker honoraria from Abbott and Edwards Lifesciences. Dr Estevez-Loureiro is a consultant for Abbott Vascular, Boston Scientific, and Edwards Lifesciences. Dr Nickenig has received honoraria for lectures or advisory board membership from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Schofer is a consultant for Edwards Lifesciences. Dr Sievert has received study honoraria to the institution, travel expenses, and consulting fees from 4tech Cardio, Abbott, Ablative Solutions, Adona Medical, Akura Medical, Ancora Heart, Append Medical, Axon, Bavaria Medizin Technologie, Bioventrix, Boston Scientific, Cardiac Dimensions, Cardiac Success, Cardimed, Cardionovum, CeloNova Biosciences, Contego, Coramaze, CroíValve, CSL Behring, CVRx, Dinova, Edwards Lifesciences, EndoBar, Endologix, EndoMatic, Esperion Therapeutics, Hangzhou Nuomao Medtech, Holistick Medical, InterShunt Technologies, Intervene, K2, Laminar, Life Tech Care, Magenta, Maquet Getinge Group, Metavention, Mitralix, Mokita, Neurotronic, NXT Biomedical, Occlutech, Recor, Renal Guard, Shifamed, Terumo, Trisol, Vascular Dynamics, Vectorious Medtech, Venus, Venock, Vivasure Medical, Vvital Biomed, and WhiteSwell. Dr Tang has served as a physician proctor for Medtronic; has served as a consultant for Medtronic, Abbott Structural Heart, and NeoChord; has served on the transcatheter aortic valve replacement advisory board for Abbott Structural Heart; and has served on the physician advisory board for JenaValve. Dr von Bardeleben has served for trials and as a principal investigator for Abbott, Edwards Lifesciences, and Medtronic. Dr Windecker has received research, travel, or educational grants to the institution from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, Cardiovalve, CorFlow Therapeutics, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Guerbet, Infraredx, Janssen-Cilag, Johnson & Johnson, Medicure, Medtronic, Merck Sharp & Dohme, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pfizer, Polares, Regeneron, Sanofi, Servier, Sinomed, Terumo, Vifor, and V-Wave; has served as an advisory board member and/or a member of the steering or executive groups of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, Janssen, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, V-Wave, and Xeltis, with payments to the institution but no personal payments; and is a member of the steering or executive committee groups of several investigator-initiated trials that receive funding from industry, without impact on his personal remuneration. Dr Enriquez-Sarano is a consultant for Edwards Lifesciences, ChemImage, Cryolife, and HighLife. Dr Maisano is a consultant for Abbott Vascular, Medtronic, Edwards Lifesciences, Perifect, Xeltis, Transseptal Solutions, Magenta, and Cardiovalve; has received grant support from Abbott Vascular, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific, NVT, and Terumo; has received royalties from Edwards Lifesciences and 4Tech; and is a cofounder and shareholder of Transseptal Solutions, 4Tech, Cardiovalve, Magenta, Perifect, Coregard and SwissVortex. Dr Taramasso has received consultancy fees from Abbott Vascular, Edwards Lifesciences, 4Tech, Boston Scientific, CoreMedic, Mitraltech, and SwissVortex (outside the submitted work). 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: Tricuspid regurgitation (TR) is a common valve disease that has a significant impact on patients' quality of life., Objectives: This study sought to report the final 3-year outcomes of tricuspid transcatheter edge-to-edge repair (T-TEER) with the TriClip (Abbott) implant from the TRILUMINATE (TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR) study for the treatment of severe symptomatic TR., Methods: The TRILUMINATE study (N = 98 subjects) is an international, prospective, single-arm, multicenter study to investigate the safety and performance of T-TEER with the TriClip implant in patients with symptomatic moderate or greater TR. Echocardiographic assessments were performed at a core laboratory., Results: At 3 years, TR was reduced to moderate or less in 79% of subjects, and a reduction of at least 1 grade was achieved in 92% of subjects. TR reduction achieved at 1 year was sustained through 3 years. Subjects also experienced an improvement in heart failure symptoms assessed by NYHA functional class and quality of life assessed by the Kansas City Cardiomyopathy Questionnaire at 3 years compared to baseline. The site-reported heart failure hospitalization rate decreased from 0.56 events/patient-year 1 year before device implantation to 0.14 events/patient-year 3 years after device implantation, representing a reduction of 75% (P < 0.0001)., Conclusions: In the longest follow-up to date of any T-TEER therapy, the TRILUMINATE study demonstrated that the TriClip procedure is both safe and effective, with sustained benefits at 3 years in subjects with symptomatic moderate or greater TR. (TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR [TRILUMINATE]; NCT03227757)., Competing Interests: Funding Support and Author Disclosures This study was supported by Abbott Structural Heart. Dr Nickenig has received research funding and honoraria from Abbott, Edwards Lifesciences, and Medtronic; and has participated in clinical trials with Abbott, Edwards Lifesciences, and Medtronic. Dr Lurz has served as a consultant for Abbott Structural Heart, Edwards Lifesciences, Medtronic, ReCor, and Occlutech. Dr Sorajja has served as a consultant for 4C Medical, Abbott Structural, Adona, Boston Scientific, Edwards Lifesciences, Foldax, GE Medical, GLG, Medtronic, Phillips, Siemens, WL Gore, vDyne, and xDot; and has received personal fees from Abbott Vascular (outside the submitted work). Dr von Bardeleben has received institutional research grants and speaker honorarium from Abbott Vascular and Edwards Lifesciences; and has received nonfinancial trial support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Lifetec, and Medtronic. Dr Sitges has served as a consultant for Abbott, Edwards Lifesciences, Metronic, and General Electric; has received speaker honoraria from Abbott, Edwards Lifesciences, Medtronic, and General Electric; and has received speaker honoraria and travel and grant support from Abbott. Dr Hausleiter has received speaker honoraria and research support from Abbott Vascular and Edwards Lifesciences. Dr Trochu has received speaker honoraria, travel support, and grant support from Abbott and Novartis; has received honoraria for lectures or advisory boards from Amgen, Bayer, and Resmed; and has been an unpaid member of the Corvia Medical Scientific Advisory Group. Dr Näbauer has received speaker honoraria from Abbott. Dr Heitkemper is an employee of Abbott. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; and has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: A prior Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry-based analysis reported similar 1-year clinical outcomes with small (20-mm) vs large (≥23-mm) balloon-expandable valves (BEV)., Objectives: The aim of this study was to describe mid-term 3-year clinical outcomes for small vs large BEV and the relationship between discharge echocardiographic mean gradient (MG) and different definitions of prothesis-patient mismatch (PPM) with clinical outcomes., Methods: Using the TVT Registry with Centers for Medicare and Medicaid Services linkage, a propensity-matched analysis of patients receiving 20- vs ≥23-mm BEVs was performed. Spline curves and Kaplan-Meier plots with adjusted HRs determined the relationship between MG and 3-year mortality., Results: In total, 316,091 patients were analyzed; after propensity matching, 8,100 pairs of each group were compared. The 20-mm BEV was associated with higher MGs compared with ≥23-mm BEVs (16.2 ± 7.2 mm Hg vs 11.8 ± 5.7 mm Hg; P < 0.0001). At 3 years, there was no difference in mortality between 20- and ≥23-mm BEVs (31.5% vs 32.5%, respectively; HR: 0.97; 95% CI: 0.90-1.05). Compared with an MG of 10 to 30 mm Hg, an MG <10 mm Hg (HR: 1.25; 95% CI:1.22-1.27) was associated with increased 3-year mortality. Measured severe PPM and predicted no PPM were associated with increased 3-year mortality (33.5% vs 32.9% vs 32.1%; P < 0.0001) and (33.5% vs 31.1% vs 30%; P < 0.0001), respectively. Low MG and severe measured PPM were associated with lower left ventricular ejection fraction (LVEF)., Conclusions: Patients with small-prosthesis BEVs (20 mm) had identical 3-year survival as those with larger (≥23-mm) BEV valves. Severe measured PPM and low MG (<10 mm Hg), but not predicted severe PPM, were associated with lower LVEF and increased mortality, suggesting that LVEF is the culprit for worse outcomes., Competing Interests: Funding Support and Author Disclosures Dr Eng is a clinical proctor for Medtronic and Edwards Lifesciences. Dr Khalili has received a research grant from Edwards Lifesciences; and has received speaker fees from Abbott Vascular. Dr Vavalle is a consultant for Edwards Lifesciences. Dr Southard has received personal fees from Edwards Lifesciences and Boston Scientific. Dr Hahn has received speaker fees from Boston Scientific, Baylis Medical, Edwards Lifesciences, and Medtronic; has received consulting fees from Abbott Structural, Edwards Lifesciences, Gore Associates, Medtronic, Navigate, and Philips Healthcare; has received nonfinancial support from 3mensio; holds equity with Navigate; and is chief scientific officer of the echocardiography core laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr Wang has received research grant support from Boston Scientific; and is a consultant for Edwards Lifesciences, Abbott Vascular, Boston Scientific, and Materialise. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Statistical analyses were performed by Edwards Lifesciences. The views or opinions presented here do not represent those of the American College of Cardiology, the Society of Thoracic Surgeons, or the TVT Registry., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Pathologic left ventricular remodeling and valvular heart disease may contribute to the clinical presentation and outcomes of patients presenting with heart failure, and limit the effectiveness of guideline-directed medical therapy. Although surgical interventions including surgical ventricular restoration techniques and valve repair or replacement are effective therapies, there is growing evidence that transcatheter interventions may be options for patients with persistent symptoms of heart failure despite optimal medical therapy, where surgical options may be limited. This scientific statement will review the current available and investigational percutaneous strategies for the management of structural contributors to heart failure: dilated left ventricular cardiomyopathies and valvular heart disease., Competing Interests: Funding Support and Author Disclosures Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic, Philips Healthcare, and Siemens Healthineers; and has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Edwards Lifesciences, Medtronic and Novartis. Dr Lindenfeld has received consulting fees from Abbott Structural, Axon, Alleviant, AstraZeneca, Boston Scientific, CVRx, Edwards Lifesciences, Merck, Medtronic, VWave, Vascular Dynamics, and Whiteswell; and has received research grants from AstraZeneca, Volumetrix, and Sensible Medical. Dr Lim has received consultant fees for Philips, Venus, and Valgen; and has received research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Mack has served as the coprincipal investigator or study chair for clinical trials sponsored by Abbott, Edwards Lifesciences, and Medtronic. Dr Burkhoff has received institutional support from Abiomed, Alleviant, Axon Therapies, Edwards Lifesciences, and Fire1; and has received consulting fees from Aquapass, Axon Therapies, BackBeat Medical, Corvia, BioMind, Impulse Dynamics, and Therox/Zoll., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: Evaluation of left and right ventricular (RV) longitudinal systolic function may enhance risk stratification following aortic valve replacement (AVR). The study objective was to evaluate the changes in left and RV longitudinal systolic function and RV-pulmonary artery (RV-PA) coupling from baseline to 30 days and 1 year after AVR., Methods and Results: Left ventricular (LV) longitudinal strain (LS), tricuspid annulus plane systolic excursion (TAPSE), and RV-PA coupling were evaluated in patients from the PARTNER 2A surgical AVR (SAVR) arm (n = 985) and from the PARTNER 2 SAPIEN 3 registry (n = 719). TAPSE and RV-PA coupling decreased significantly following SAVR, but remained stable following TAVR. Lower LV LS, TAPSE, or RV-PA coupling at baseline was associated with increased risk of the composite of death, hospitalization, and stroke at 5 years [adjusted hazard ratios (HRs) for LV LS < 15%: 1.24, 95% confidence interval (CI) 1.05-1.45, P = 0.001; TAPSE < 14 mm: 1.44, 95% CI 1.21-1.73, P < 0.001; RV-PA coupling < 0.55 mm/mmHg: 1.32, 95% CI 1.07-1.63, P = 0.011]. Reduced TAPSE at baseline was the most powerful predictor of the composite endpoint at 5 years. Patients with LV ejection fraction <50% at baseline had increased risk of the primary endpoint with SAVR (HR: 1.34, 95% CI 1.08-1.68, P = 0.009) but not with TAVR (HR: 1.12, 95% CI 0.88-1.42). Lower RV-PA coupling at 30 days showed the strongest association with cardiac mortality., Conclusion: SAVR but not TAVR was associated with a marked deterioration in RV longitudinal systolic function and RV-PA coupling. Lower TAPSE and RV-PA coupling at 30 days were associated with inferior clinical outcomes at 5 years. In patients with LVEF < 50%, TAVR was associated with superior 5-year outcomes., Competing Interests: Conflict of interest: J.T. is consultant for Abbott, Philips Healthcare, and General Electric. R.T.H. reports speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic, and Philips Healthcare; she has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Edwards Lifesciences, Medtronic, and Novartis; she is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored tricuspid valve trials, for which she receives no direct industry compensation. M.-A.C. has research grant with Medtronic and core laboratory contract with Edwards Lifesciences without direct compensation. W.J. is consultant for Boston Scientific and BridgeBio. F.M.A. and N.J.W. have institutional research grants as directors of an academic core lab from Edwards, Abbott, Medtronic, Boston Scientific, Biotronik, Corcyn, and Foldax. They have no personal disclosures. N.A. received speakers fees from Abbott Vascular, GE Healthcare, and Philips ultrasound and research grants from Alnylam and Pfizer. H.C.H. reports institutional research funding from Abbott, Boston Scientific, Edwards Lifesciences, Highlife, Medtronic, and WL Gore; consulting fees from Edwards Lifesciences, Medtronic, Wells Fargo, and WL Gore; and equity in Holistick Medical and Micro Interventional Devices. M.J.M. has served as a Co-Pi for clinical trials for Abbott and Edwards Lifesciences and as Study Chair for a trial for Medtronic. All roles were uncompensated. V.T. is consultant or researcher for Abbott Vascular, Boston Scientific, CryoLife, Edwards Lifesciences, Medtronic, and Shockwave. The other authors have nothing to disclose., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: Tricuspid regurgitation (TR) is highly prevalent in the transcatheter aortic valve replacement (TAVR) population, but clear management guidelines are lacking., Objectives: The aims of this study were to elucidate the prevalence and consequences of severe TR in patients with aortic stenosis undergoing TAVR and to examine the change in TR post-TAVR, including predictors of improvement and its impact on longer term mortality., Methods: Using Centers for Medicare and Medicaid Services-linked TVT (Transcatheter Valve Therapy) Registry data, a propensity-matched analysis was performed among patients undergoing TAVR with baseline mild, moderate, or severe TR. Kaplan-Meier estimates were used to assess the impact of TR on 3-year mortality. Multivariable analysis identified predictors of 30-day TR improvement., Results: Of the 312,320 included patients, 84% had mild, 13% moderate, and 3% severe TR. In a propensity-matched cohort, severe baseline TR was associated with higher in-hospital mortality (2.5% vs 2.1% for moderate TR and 1.8% for mild TR; P = 0.009), higher 1-year mortality (24% vs 19.6% for moderate TR and 16.6% for mild TR; P < 0.0001), and 3-year mortality (54.2% vs 48.5% for moderate TR and 43.3% for mild TR; P < 0.0001). Among the patients with severe TR at baseline, 76.4% improved to moderate or less TR 30 days after TAVR. Baseline mitral regurgitation moderate or greater, preserved ejection fraction, higher aortic valve gradient, and better kidney function predicted TR improvement after TAVR. However, severe 30-day residual TR was associated with higher 1-year mortality (27.4% vs 18.7% for moderate TR and 16.8% for mild TR; P < 0.0001)., Conclusions: Severe baseline and 30-day residual TR after TAVR are associated with increased mortality up to 3 years. This analysis identifies a higher risk group that could be evaluated for the recently approved tricuspid interventions., Competing Interests: Funding Support and Author Disclosures Statistical analyses were supported by Edwards Lifesciences. Dr Zahr has received research and educational grants and consultation honoraria from Edwards Lifesciences, Medtronic, and Philips. Dr Elmariah is a consultant for Edwards Lifesciences and Medtronic; and has received institutional research support from Edwards Lifesciences and Medtronic. Dr Vemulapalli has received grants or contracts from the American College of Cardiology, the STS, Cytokinetics, Abbott Vascular, the National Institutes of Health (R01 and SBIR), and Boston Scientific; and has performed consultation work for and holds advisory board status with Janssen, the American College of Physicians, HeartFlow, and Edwards Lifesciences. Dr Kodali is a consultant for Admedus, Meril Lifesciences, JenaValve, and Abbott Vascular; and holds equity in Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve, Supira, and Admedus. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; holds institutional consultation contracts with no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; holds stock options with Navigate; and is the 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 Davidson has received research grant support from and performed unpaid consultation for Edwards Lifesciences. Dr O’Neill is a consultant for Abiomed, Medtronic, and Boston Scientific. Dr Bethea has received consultation fees from Abbott Vascular. Dr Thourani has been an advisor for Abbott Vascular, Artivion, AtriCure, Boston Scientific, Edwards Lifesciences, Medtronic, and Shockwave Medical. Dr Chakravarty is a consultant for Edwards Lifesciences, Boston Scientific, Medtronic, and Abbott. Dr Gupta is a consultant for Boston Scientific and Shockwave Medical; and holds equity in Heartbeat Health and iCardio.ai. Dr Makkar has received research grants from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific; has received personal proctoring funds from Edwards Lifesciences; has received travel support from Edwards Lifesciences, Abbott, and Boston Scientific; and serves as national principal investigator for the Portico (Abbott) and Acurate (Boston Scientific) U.S. investigation device exemption trials. 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.)

Severe tricuspid regurgitation remains largely undertreated given limited treatment options. Transcatheter tricuspid valve interventions have emerged as a promising therapy for these patients, and the TRISCEND II pivotal trial is the first randomized controlled trial to evaluate transcatheter tricuspid valve replacement (TTVR). The TRISCEND II pivotal trial studies the transcatheter EVOQUE (Edwards Lifesciences, Irvine, California) tricuspid valve replacement system using a United States Food and Drug Administration Breakthrough Device Designation-a program intended to provide timely access to medical devices by speeding up development, assessment, and review. The TRISCEND II trial is a prospective, multicenter trial that randomizes patients with symptomatic severe tricuspid regurgitation to treatment with either TTVR in conjunction with optimal medical therapy or optimal medical therapy alone. The trial's novel 2-phase design evaluates 30-day safety and 6-month effectiveness end points for the first 150 patients in the initial phase and a 1-year safety and effectiveness end point for the full cohort of 400 patients in the second phase. The TRISCEND II trial's 2-phase trial design provided an opportunity for early review and led to the first commercial approval of a TTVR system. In conclusion, the design of the TRISCEND II trial will likely inform future transcatheter tricuspid device trials., Competing Interests: Declaration of competing interest Dr. Grayburn receives grant support from Abbott Vascular, CardioMech, Cardiovalve, Edwards Lifesciences, Medtronic, Neochord, Restore Medical, and 4C Medical and Advisory Board/Consultant fees from Abbott Vascular, Edwards Lifesciences, Medtronic, and 4C Medical. Dr. Kodali reports institutional research grants from Edwards Lifesciences, Medtronic, Abbott, Boston Scientific, and JenaValve; and is a consultant to Admedus, TriCares, TriFlo, X-Dot, MicroInterventional Devices, Supira, Adona, Tioga, Helix Valve Repair, and moray Medical and serves on advisory boards for Dura Biotech, Thubrikar Aortic Valve Inc., Phillips, Medtronic, and Boston Scientific. Dr. Hahn reports 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, Edwards Lifesciences, Medtronic, and Novartis; and is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored tricuspid valve trials, for which she receives no direct industry compensation. Dr. Lurz has received institutional fees and research grants from Abbott Vascular, Edwards Lifesciences, and ReCor, honoraria from Edwards Lifesciences, Abbott Medical, Innoventric, ReCor, and Boehringer Ingelheim, and has stock options with Innoventric. Dr. Thourani is an advisor or researcher for Artivion, AtriCure, Abbott Vascular, Boston Scientific, Edwards Lifesciences, JenaValve, and Shockwave. Dr. Mack reports consulting fees and research grants from Edwards Lifesciences. Dr. Leon reports institutional clinical research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Efraim Kozorovitsky, Suzanne Gilmore, Chandan Vinekar, Bonnie Zhang, Kristin Boulware, Ann Krzmarzick, Don Nguyen, Minh Vu, and Dr Feldman are employed by Edwards Lifesciences., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: In patients with low-gradient aortic stenosis (AS) and low transvalvular flow, dobutamine stress echocardiography (DSE) is recommended to determine AS severity, whereas the degree of aortic valve calcification (AVC) supposedly correlates with AS severity according to current European and American guidelines., Objectives: The purpose of this study was to assess the relationship between AVC and AS severity as determined using echocardiography and DSE in patients with aortic valve area <1 cm 2 and peak aortic valve velocity <4.0 m/s., Methods: All patients underwent DSE to determine AS severity and multislice computed tomography to quantify AVC. Receiver-operating characteristics curve analysis was used to assess the diagnostic value of AVC for AS severity grading as determined using echocardiography and DSE in men and women., Results: A total of 214 patients were included. Median age was 78 years (25th-75th percentile: 71-84 years) and 25% were women. Left ventricular ejection fraction was reduced (<50%) in 197 (92.1%) patients. Severe AS was diagnosed in 106 patients (49.5%). Moderate AS was diagnosed in 108 patients (50.5%; in 77 based on resting transthoracic echocardiography, in 31 confirmed using DSE). AVC score was high (≥2,000 for men or ≥1,200 for women) in 47 (44.3%) patients with severe AS and in 47 (43.5%) patients with moderate AS. AVC sensitivity was 44.3%, specificity was 56.5%, and positive and negative predictive values for severe AS were 50.0% and 50.8%, respectively. Area under the receiver-operating characteristics curve was 0.508 for men and 0.524 for women., Conclusions: Multi-slice computed tomography-derived AVC scores showed poor discrimination between grades of AS severity using DSE and cannot replace DSE in the diagnostic work-up of low-gradient severe AS., Competing Interests: Funding Support and Author Disclosures Dr Van Mieghem has received grant support/research contracts from Abbott Vascular, Boston Scientific, Medtronic, Edwards Lifesciences, Daiichy Sankyo, AstraZeneca, and PulseCath BV; and has received consulting/speaker fees from Abbot Vascular, Boston Scientific Corporation, Medtronic, Daiichy Sankyo, PulseCath BV, JenaValve, and Amgen. Dr Mehran has received grant support/research contracts from Abbott, Abiomed, Alleviant Medical, Amgen, AM-Pharma, Arena Pharmaceuticals, AstraZeneca, Atricure Inc, Biosensors, Biotronik, Boston Scientific, Bristol-Myers Squibb, CardiaWave, CeloNova, Chiesi, Concept Medical, Cytsorbents, Daiichy-Sankyo, Element Science, Faraday, Humacyte, Idorsia Pharmaceuticals, Janssen Pharmaceuticals, Magenta, MedAlliance, Mediasphere, Medtelligence, Medtronic, MJH Healthcare, Novartis, OrbusNeich, Penumbra, PhaseBio, Philips, Pi-Cardia, PLx Pharma, Protembis, RenalPro, RM Global, Shockwave Medical, Vivasure, and Zoll; has received consulting/speaker fees from AstraZeneca, E.R. Squibb and Sons LLC, Esperion Science/Innovativa Biopharma, Ionis Pharmaceuticals, IQVIA, J-Calc, McVeigh Global, Novartis, Novo Nordisk, Overcome, Primer Healthcare of New Jersey, Radcliffe, SL Solutions, TARSUS Cardiology, Vectura, and WebMD; and she has equity in Applied Therapeutics, Elixir, and STEL. Dr Mehran’s spouse has equity in ControlRad. Dr Kodali has received grant support/research contracts from Admedus, Dura Biotech, Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve; has received consulting/speaker fees from Admedus, Dura Biotech, TriCares, X-Dot, Tioga, Helix Valve Repair, and Moray Medical; and has equity in Dura Biotech, Microinterventional Devices, Thubrika Aortic Valve Inc, Supira, Admedus, Triflo, and Adona. Dr Hahn has received consulting/speaker fees from Abbott Structural, Medtronic, Edwards Lifesciences, Boston Scientific, Baylis Medical, Navigate, Philips Healthcare, Siemens Healthcare, and 3mensio; and has equity in Navigate. Dr Bax has received grant support/research contracts from Biotronic, Boston Scientific, Medtronic, Bayer AG, and Edwards Lifesciences; and has received consulting/speaker fees from Abbott Vascular and Edwards Lifesciences. Drs Veulemans and Zeus have received consulting fees, travel expenses, or study honoraria from Medtronic, Edwards Lifesciences, and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)