Search

In this paper, we simulate the response of fiber Bragg grating (FBG) sensors embedded in the adhesive layer of a composite lap that is subjected to harmonic excitation. To simulate accumulated fatigue damage at the adhesive layer, two forms of numerical nonlinearities are introduced into the model: (1) progressive plastic deformation of the adhesive and (2) changing the boundary of an interfacial defect at the adhesive layer across the overlap shear area. The simulation results are compared with previous measurements of the dynamic, full-spectral response of such FBG sensors for condition monitoring of the lap joint. Short-time Fourier transforms (STFT) of the locally extracted axial strain time histories reveal a transition to nonlinear behavior of the composite lap joint by means of intermittent frequencies that were observed in the experimental measurements and are not associated with the external excitation. The simulation results verify that the nonlinear changes in measured dynamic FBG responses are due to the progression of damage in the lap joint. [ABSTRACT FROM AUTHOR]

In this study we measure the in situ response of a fiber Bragg grating (FBG) sensor embedded in the adhesive layer of a single composite lap joint, subjected to harmonic excitation after fatigue loading. After a fully reversed cyclic fatigue loading is applied to the composite lap joint, the full-spectral response of the sensor is interrogated at 100 kHz during two loading conditions: with and without an added harmonic excitation. The full-spectral information avoided dynamic measurement errors often experienced using conventional peak wavelength and edge filtering techniques. The short-time Fourier transform (STFT) is computed for the extracted peak wavelength information to reveal time-dependent frequencies and amplitudes of the dynamic FBG sensor response. The dynamic response of the FBG sensor indicated a transition to strong nonlinear dynamic behavior as fatigue-induced damage progressed. The ability to measure the dynamic response of the lap joint through sensors embedded in the adhesive layer can provide in situ monitoring of the lap joint condition. [ABSTRACT FROM AUTHOR]

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: 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: We 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 © 2024 The Authors. 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: High surgical risk may preclude mitral valve replacement in many patients. Transcatheter mitral valve replacement (TMVR) using transfemoral transseptal access is a novel technology for the treatment of mitral regurgitation (MR) in high-risk surgical patients., Objectives: This analysis evaluates 30-day and 1-year outcomes of the Intrepid TMVR Early Feasibility Study in patients with ≥moderate-severe MR., Methods: The Intrepid TMVR Early Feasibility Study is a multicenter, prospective, single-arm study. Clinical events were adjudicated by a clinical events committee; endpoints were defined according to Mitral Valve Academic Research Consortium criteria., Results: A total of 33 patients, enrolled at 9 U.S. sites between February 2020 and August 2022, were included. The median age was 80 years, 63.6% of patients were men, and mean Society of Thoracic Surgeons Predicted Risk of Mortality for mitral valve replacement was 5.3%. Thirty-one (93.9%) patients were successfully implanted. Median postprocedural hospitalization length of stay was 5 days, and 87.9% of patients were discharged to home. At 30 days, there were no deaths or strokes, 8 (24.2%) patients had major vascular complications and none required surgical intervention, there were 4 cases of venous thromboembolism all successfully treated without sequelae, and 1 patient had mitral valve reintervention for severe left ventricular outflow tract obstruction. At 1 year, the Kaplan-Meier all-cause mortality rate was 6.7%, echocardiography showed ≤mild valvular MR, there was no/trace paravalvular leak in all patients, median mitral valve mean gradient was 4.6 mm Hg (Q1-Q3: 3.9-5.3 mm Hg), and 91.7% of survivors were in NYHA functional class I/II with a median 11.4-point improvement in Kansas City Cardiomyopathy Questionnaire overall summary scores., Conclusions: The early benefits of the Intrepid transfemoral transseptal TMVR system were maintained up to 1 year with low mortality, low reintervention, and near complete elimination of MR, demonstrating a favorable safety profile and durable valve function., Competing Interests: Funding Support and Author Disclosures This work was funded by Medtronic. Dr Zahr has received institutional grant support from Edwards Lifesciences and Medtronic. Dr Song has received consulting fees from Medtronic and Edwards Lifesciences. Dr Chadderdon has received consulting fees from Medtronic and Edwards Lifesciences; and grant support from Medtronic and GE Healthcare. Dr Gada has received consulting fees from Medtronic, Boston Scientific, and Bard Medical. Dr Mumtaz has received consulting fees and grant support from Medtronic and Edwards Lifesciences; and consulting fees from Z Medica and from the Japanese Organization for Medical Device Development. Dr Byrne has received consulting fees from Medtronic and Abbott Vascular. Dr Kirshner has received consulting fees from Medtronic. Dr Sharma has served as a proctor for Medtronic; and received research grant support from the Norton Healthcare Foundation. Dr Kodali has received consultant fees from Admedus and Dura Biotech; holds equity in Dura Biotech, Microinterventional Devices, Thubrika Aortic Valve, Supira, Admedus, TriFlo, and Anona; and has received institutional grant support from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve. Dr George has received consulting fees from Cardiomech, Mitremedical, Atricure, Zimmer Biomet, Durvena, and Valcare Medical. Dr Sorrajja has received grant support from Medtronic for participation in the Steering Committee of the APOLLO trial; and consulting fees from 4C Medical, Abbott Structural, Anteris, BioSense Webseter, Edwards Lifesciences, Foldax, Medtronic, Phillips, Shifamed, Siemens, vDyne, W.L. Gore xDOT. Dr Bapat has received personal fees for consultancy and speaker service from Medtronic; and served as a consultant for Edwards Lifesciences, 4C, and Boston Scientific. Dr Bajwa has received personal and institutional consulting fees from Medtronic. Dr Weiss has received personal and institutional consulting fees from Medtronic and Baxter. Dr Thaden has received institutional consulting fees from Medtronic and speaker fees from Edwards Lifesciences. Ms. Gearhart is an employee of Medtronic. Dr Lim has received institutional grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic; and consulting fees from Keystone, Pipeline, Valgen, and Venus. Dr Reardon has received institutional consulting fees from Medtronic, W.L. Gore & Associates, Boston Scientific, and Abbott Vascular. Dr Adams’s institution (Icahn School of Medicine at Mount Sinai) has received royalty payments from Edwards Lifesciences and Medtronic for intellectual property related to the development of valve repair rings; and he has served as the national co-principal investigator of the Medtronic APOLLO Food and Drug Administration pivotal trial, the NeoChord ReChord Food and Drug Administration pivotal trial, the Medtronic CoreValve US pivotal trial, and the Abbott TRILUMINATE pivotal trial. Dr Mack has served as a trial co-principal investigator for Abbott Vascular; as the study chair for Medtronic; and as a trial co–principal investigator for Edwards Lifesciences (both personal and institutional). Dr Leon has received personal and institutional grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Favorable 6-month outcomes from the CLASP IID Registry (Edwards PASCAL transcatheter valve repair system pivotal clinical trial) demonstrated that mitral valve transcatheter edge-to-edge repair with the PASCAL transcatheter valve repair system is safe and beneficial for treating prohibitive surgical risk degenerative mitral regurgitation (DMR) patients with complex mitral valve anatomy., Objectives: The authors sought to assess 1-year safety, echocardiographic and clinical outcomes from the CLASP IID Registry., Methods: Patients with 3+ or 4+ DMR who were at prohibitive surgical risk, had complex mitral valve anatomy based on the MitraClip Instructions for Use, and deemed suitable for treatment with the PASCAL system were enrolled prospectively. Safety, clinical, echocardiographic, functional, and quality-of-life outcomes were assessed at 1 year. Study oversight included a central screening committee, echocardiographic core laboratory, and clinical events committee., Results: Ninety-eight patients were enrolled. One-year Kaplan-Meier (KM) estimates of freedom from composite major adverse events, all-cause mortality, and heart failure hospitalization were 83.5%, 89.3%, and 91.5%, respectively. Significant mitral regurgitation (MR) reduction was achieved at 1 year (P < 0.001 vs baseline) including 93.2% at MR ≤2+ and 57.6% at MR ≤1+ with improvements in related echocardiographic measures. NYHA functional class and Kansas City Cardiomyopathy Questionnaire score also improved significantly (P < 0.001 vs baseline)., Conclusions: At 1 year, treatment with the PASCAL system demonstrated safety and significant MR reduction, with continued improvement in clinical, echocardiographic, functional, and quality-of-life outcomes, illustrating the value of the PASCAL system in the treatment of prohibitive surgical risk patients with 3+ or 4+ DMR and complex mitral valve anatomy., Competing Interests: Funding Support and Author Disclosures Dr Smith is on the CLASP IID Trial leadership team and has received institutional grant and travel support for device evaluation from Edwards Lifesciences; has received institutional grants from Artivion; and honoraria for speaking from Artivion and Medtronic. Dr Lim is a consultant for Opus, Nyra, Philips, Venus, and Valgen; and has received research grants from Abbott, Boston Scientific, Corvia, Edwards Lifesciences, Medtronic, V Wave, and WL Gore. Dr Gillam is a consultant for Philips, Bracco, and Edwards Lifesciences; and directs an echocardiography core laboratory for Abbott, Edwards Lifesciences, and Medtronic for which she receives no direct compensation. Dr Zahr is a consultant and has received research grants from Edwards Lifesciences. Dr Chadderdon is an educational consultant for Edwards Lifesciences and Medtronic. Dr Makkar is a consultant and has received research grants from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific. Dr Goldman consults in minimally invasive mitral valve observation for Edwards Lifesciences. Dr Rudolph has received research grants from Edwards Lifesciences, Abbott, and Boston Scientific. Dr Hermiller is a consultant and proctor for Edwards Lifesciences. Dr Dhoble is a consultant and proctor for Edwards Lifesciences and Abbott. Dr Smalling has received clinical trial grant support from Edwards Lifesciences, Medtronic, and Abbott; and serves as a consultant for Abbott. Dr Latib is a consultant and serves on the advisory board for Boston Scientific, Edwards Lifesciences, Medtronic, Abbott, and Philips. Dr Kodali is a consultant for Admedus, Dura Biotech, TriCares, Phillips, and TriFlo; has received institutional research funding from Edwards Lifesciences, Medtronic, Abbott, Boston Scientific, and JenaValve; and serves on a scientific advisory board and has received equity from Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve Inc, Supira, Admedus, TriFlo, Adona, Tioga, and X-Dot. Dr Lurz has received institutional grants from Edwards Lifesciences, Abbott, and ReCor. Dr O’Neill is a consultant for Abiomed, BSCI, and Abbott; and was previously a consultant for Edwards Lifesciences. Dr Laham is a speaker for Abbott, Edwards Lifesciences, and Medtronic. Dr Kar is a consultant for Abbott, Medtronic, Boston Scientific, WL Gore, Laminar, Intershunt, and V wave; has received institutional research grants from Abbott, Medtronic, Boston Scientific, Edwards Lifesciences, and Highlife; is the co-national principal investigator for the REPAIR MR Trial and EXPAND registry and co-national principal investigator for the PINNACLE FLX Trial and CHAMPION Trial; serves on the steering committee for the Triluminate Trial; and is an executive committee member for the RELIEVE HF Trial. Dr Schofer has received travel support from Edwards Lifesciences and Abbott/St. Jude Medical; has received speaker honoraria from Edwards Lifesciences and Boston Scientific; and is a consultant for Edwards Lifesciences and Abbott. Dr Inglessis-Azuaje is a proctor for Edwards Lifesciences and Medtronic; and serves as a lecturer for Edwards Lifesciences and Boston Scientific. Dr Baldus has received research funding from Abbott; and has received lecturing fees from Edwards Lifesciences, Abbott, and Medtronic. Dr Szerlip is a proctor for Edwards Lifesciences and Abbott; is a speaker for Edwards Lifesciences and Boston Scientific; serves as a national principal investigator for an early feasibility study for Edwards Lifesciences; serves on the advisory board for Abbott; and is part of a steering committee for Medtronic. Dr Kliger is a consultant for and has received speaker honoraria from Edwards Lifesciences, Medtronic, and Siemens. Dr Webb is a consultant and national principal investigator for Edwards Lifesciences–sponsored clinical studies; and has received speaking honoraria, travel support, or grant support from Edwards Lifesciences. Dr von Bardeleben is a principal investigator for Phase 3, post-market clinical trials and investigator-initiated trials (Reshape II HF, TENDER, EuroSMR and other registries) for Abbott, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Neochord, Philips and Siemens. Dr Ruf has received speaker, consulting, and proctoring fees from Abbott Laboratories and Edwards Lifesciences. Dr Guerrero has received grant support, and consulting and proctoring fees from Edwards Lifesciences. Dr McCabe is a consultant and has received honoraria from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; and holds equity in Excision Medical. Dr Davidson is a consultant and has received research grant support from Edwards Lifesciences. Dr Shah has received grant support, consulting, and proctoring fees from Edwards Lifesciences. Dr Yadav is a consultant and speaker for Edwards Lifesciences, Abbott, Dasi Simulations, and Shockwave Medical. Dr Koulogiannis is a consultant and advisory board member for Edwards Lifesciences; and is a speaker for Abbott. Dr Marcoff serves as a member of the echocardiography core laboratory for Edwards Lifesciences and Abbott for which he receives no direct compensation. Dr Hausleiter is a consultant, and receives speaker honoraria and institutional research support from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023. Published by Elsevier Inc.)

Background and Aims: For patients with symptomatic, severe tricuspid regurgitation (TR), early results of transcatheter tricuspid valve (TV) intervention studies have shown significant improvements in functional status and quality of life associated with right-heart reverse remodelling. Longer-term follow-up is needed to confirm sustained improvements in these outcomes., Methods: The prospective, single-arm, multicentre TRISCEND study enrolled 176 patients to evaluate the safety and performance of transcatheter TV replacement in patients with ≥moderate, symptomatic TR despite medical therapy. Major adverse events, reduction in TR grade and haemodynamic outcomes by echocardiography, and clinical, functional, and quality-of-life parameters are reported to one year., Results: Enrolled patients were 71.0% female, mean age 78.7 years, 88.0% ≥ severe TR, and 75.4% New York Heart Association classes III-IV. Tricuspid regurgitation was reduced to ≤mild in 97.6% (P < .001), with increases in stroke volume (10.5 ± 16.8 mL, P < .001) and cardiac output (0.6 ± 1.2 L/min, P < .001). New York Heart Association class I or II was achieved in 93.3% (P < .001), Kansas City Cardiomyopathy Questionnaire score increased by 25.7 points (P < .001), and six-minute walk distance increased by 56.2 m (P < .001). All-cause mortality was 9.1%, and 10.2% of patients were hospitalized for heart failure., Conclusions: In an elderly, highly comorbid population with ≥moderate TR, patients receiving transfemoral EVOQUE transcatheter TV replacement had sustained TR reduction, significant increases in stroke volume and cardiac output, and high survival and low hospitalization rates with improved clinical, functional, and quality-of-life outcomes to one year. Funded by Edwards Lifesciences, TRISCEND ClinicalTrials.gov number, NCT04221490., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Interest in the pathophysiology, etiology, management, and outcomes of patients with tricuspid regurgitation (TR) has grown in the wake of multiple natural history studies showing progressively worse outcomes associated with increasing TR severity, even after adjusting for multiple comorbidities. Historically, isolated tricuspid valve surgery has been associated with high in-hospital mortality rates, leading to the development of transcatheter treatment options. The aim of this first Tricuspid Valve Academic Research Consortium document is to standardize definitions of disease etiology and severity, as well as endpoints for trials that aim to address the gaps in our knowledge related to identification and management of patients with TR. Standardizing endpoints for trials should provide consistency and enable meaningful comparisons between clinical trials. A second Tricuspid Valve Academic Research Consortium document will focus on further defining trial endpoints and will discuss trial design options., (© 2023 The Author(s). Published by Elsevier Inc on behalf of American College of Cardiology and The Society of Thoracic Surgeons and by Oxford University Press on behalf of the European Society of Cardiology.)

Background: The CLASP IID (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical) trial is the first randomized controlled trial comparing the PASCAL system and the MitraClip system in prohibitive risk patients with significant symptomatic degenerative mitral regurgitation (DMR)., Objectives: The study sought to report primary and secondary endpoints and 1-year outcomes for the full cohort of the CLASP IID trial., Methods: Prohibitive-risk patients with 3+/4+ DMR were randomized 2:1 (PASCAL:MitraClip). One-year assessments included secondary effectiveness endpoints (mitral regurgitation [MR] ≤2+ and MR ≤1+), and clinical, echocardiographic, functional, and quality-of-life outcomes. Primary safety (30-day composite major adverse events [MAE]) and effectiveness (6-month MR ≤2+) endpoints were assessed for the full cohort., Results: Three hundred patients were randomized (PASCAL: n = 204; MitraClip: n = 96). At 1 year, differences in survival, freedom from heart failure hospitalization, and MAE were nonsignificant (P > 0.05 for all). Noninferiority of the PASCAL system compared with the MitraClip system persisted for the primary endpoints in the full cohort (For PASCAL vs MitraClip, the 30-day MAE rates were 4.6% vs 5.4% with a rate difference of -0.8% and 95% upper confidence bound of 4.6%. The 6-month MR≤2+ rates were 97.9% vs 95.7% with a rate difference of 2.2% and 95% lower confidence bound (LCB) of -2.5%, for, respectively). Noninferiority was met for the secondary effectiveness endpoints at 1 year (MR≤2+ rates for PASCAL vs MitraClip were 95.8% vs 93.8% with a rate difference of 2.1% and 95% LCB of -4.1%. The MR≤1+ rates were 77.1% vs 71.3% with a rate difference of 5.8% and 95% LCB of -5.3%, respectively). Significant improvements in functional classification and quality of life were sustained in both groups (P <0.05 for all vs baseline)., Conclusions: The CLASP IID trial full cohort met primary and secondary noninferiority endpoints, and at 1 year, the PASCAL system demonstrated high survival, significant MR reduction, and sustained improvements in functional and quality-of-life outcomes. Results affirm the PASCAL system as a beneficial therapy for prohibitive-surgical-risk patients with significant symptomatic DMR., Competing Interests: Funding Support and Author Disclosures The CLASP IID trial is funded by Edwards Lifesciences. Dr Zahr has served as a consultant for and received research and educational grants from Edwards Lifesciences and Medtronic. Dr Smith has served on the CLASP IID trial leadership team; received institutional grant and travel support for device evaluation from Edwards Lifesciences; received institutional grants from Artivion; and received honoraria for speaking from Artivion and Medtronic. Dr Gillam has served as a consultant for Philips, Bracco, and Edwards Lifesciences; and directed an echocardiography core laboratory for Abbott, Edwards Lifesciences, and Medtronic for which she has received no direct compensation. Dr Chadderdon has served as an educational consultant for Edwards Lifesciences and Medtronic. Dr Makkar has served as a consultant for and received research grants from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific. Dr von Bardeleben has served as a principal investigator for phase 3, postmarket clinical trials and investigator-initiated trials (Reshape II HF, TENDER, EuroSMR and other registries) for Abbott, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Neochord, Philips, and Siemens. Dr Szerlip has served as a proctor and speaker for Edwards Lifesciences; as a national principal investigator for an early feasibility study; on the advisory board and as a proctor for Abbott; as part of the steering committee for Medtronic; and as a speaker for Boston Scientific. Dr Goldman has been involved in minimally invasive mitral valve observation for Edwards Lifesciences. Dr Inglessis-Azuaje has served as a proctor and lecturer for Edwards Lifesciences; a consultant and proctor for Medtronic; and a lecturer for Boston Scientific. Dr Yadav has served as a consultant and speaker for Edwards Lifesciences, Abbott, Dasi Simulations, and Shockwave Medical. Dr Lurz has received institutional grants from Edwards Lifesciences, Abbott, and ReCor. Dr Davidson has served as a consultant and received research grant support from Edwards Lifesciences. Dr Mumtaz has served as a consultant and proctor for and received honoraria and research support from Edwards Lifesciences, Abbott, Medtronic, JOMDD, Teleflex, and Atricure. Dr Gada has served as a consultant for Medtronic, Boston Scientific, Abbott, and Becton Dickinson. Dr Kar has served as a consultant for Abbott, Medtronic, Boston Scientific, W.L. Gore, Laminar, Intershunt, and V wave; received institutional research grants from Abbott, Medtronic, Boston Scientific, Edwards Lifesciences, and Highlife; served as co-national principal investigator for the REPAIR MR trial and EXPAND registry; served as co-national principal investigator for the PINNACLE FLX trial and CHAMPION trial; served on the steering committee for the Triluminate trial; and served on the executive committee for the RELIEVE HF trial. Dr Kodali has served as a consultant for and received honoraria from Admedus, Dura Biotech, TriCares, Phillips, and TriFlo; received institutional research funding from Edwards Lifesciences, Medtronic, Abbott, Boston Scientific, and JenaValve; and served on the scientific advisory board and has received equity for Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve Inc, Supira, Admedus, TriFlo, Adona, Tioga, and X-Dot. Dr Laham has served as a speaker for and received compensation from Abbott, Edwards Lifesciences, and Medtronic. Dr Fam has served as a consultant for Edwards Lifesciences and Abbott. Dr Kessler has received speaking honoraria for Edwards Lifesciences and Abbott. Dr O’Neill has served as a consultant for Abiomed, BSCI, and Abbott; and a consultant (expired) for Edwards Lifesciences. Dr Whisenant has served as a consultant for Edwards Lifesciences and Abbott. Dr Kliger has served as a consultant for and received speaking honoraria from Edwards Lifesciences, Medtronic, and Siemens. Dr Rudolph has received research grants from Edwards Lifesciences, Abbott, and Boston Scientific. Dr Hermiller has served as a consultant and proctor for Edwards Lifesciences. Dr Morse has served as a consultant for Edwards Lifesciences. Dr Schofer has received travel support from Edwards Lifesciences and Abbott/St. Jude Medical; and speaking honoraria from Edwards Lifesciences and Boston Scientific. Dr Latib has served as a consultant and on the advisory board for Boston Scientific, Edwards Lifesciences, Medtronic, Abbott, and Philips. Dr Mahoney has received grant support, consulting, and/or proctoring fees from Edwards Lifesciences. Dr Kaneko has served on the advisory board of Edwards Lifesciences, Abbott, and Johnson & Johnson; and as a consultant for Medtronic. Dr Shah has received grant support, consulting, and/or proctoring fees from Edwards Lifesciences. Dr Price has received consulting and/or speaking honoraria from Alleviant Medical, Medtronic, Boston Scientific, Abbott, W.L. Gore, Philips Medical, Shockwave, and InnovHeart. Dr Muhammad is a consultant and proctor for Edwards Lifesciences and Medtronic. Dr Praz received personal fees from Edwards Lifesciences during the conduct of the study. Dr Koulogiannis has served as a consultant and advisory board member for Edwards Lifesciences; and a speaker for Abbott. Dr Marcoff has served as a member of the echocardiography core laboratory for Edwards Lifesciences and Abbott, for which he has received no direct compensation. Dr Hausleiter has served as a consultant for, received speaker honoraria from, and institutional research support from Edwards Lifesciences. Dr Lim has served as a consultant for LagunaTech, Nyra Medical, Opus Medical, Philips, Venus, and Valgen; and on his behalf his institution has received research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Trisol. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Surgical management of isolated tricuspid regurgitation (TR) is associated with high morbidity and mortality, thereby creating a significant need for a lower-risk transcatheter solution., Objectives: The single-arm, multicenter, prospective CLASP TR (Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation [CLASP TR] Early Feasibility Study) evaluated 1-year outcomes of the PASCAL transcatheter valve repair system (Edwards Lifesciences) to treat TR., Methods: Study inclusion required a previous diagnosis of severe or greater TR and persistent symptoms despite medical treatment. An independent core laboratory evaluated echocardiographic results, and a clinical events committee adjudicated major adverse events. The study evaluated primary safety and performance outcomes, with echocardiographic, clinical, and functional endpoints. Study investigators report 1-year all-cause mortality and heart failure hospitalization rates., Results: Sixty-five patients were enrolled: mean age of 77.4 years; 55.4% female; and 97.0% with severe to torrential TR. At 30 days, cardiovascular mortality was 3.1%, the stroke rate was 1.5%, and no device-related reinterventions were reported. Between 30 days and 1 year, there were an additional 3 cardiovascular deaths (4.8%), 2 strokes (3.2%), and 1 unplanned or emergency reintervention (1.6%). One-year postprocedure, TR severity significantly reduced (P < 0.001), with 31 of 36 (86.0%) patients achieving moderate or less TR; 100% had at least 1 TR grade reduction. Freedom from all-cause mortality and heart failure hospitalization by Kaplan-Meier analyses were 87.9% and 78.5%, respectively. Their New York Heart Association functional class significantly improved (P < 0.001) with 92% in class I or II, 6-minute walk distance increased by 94 m (P = 0.014), and overall Kansas City Cardiomyopathy Questionnaire scores improved by 18 points (P < 0.001)., Conclusions: The PASCAL system demonstrated low complication and high survival rates, with significant and sustained improvements in TR, functional status, and quality of life at 1 year. (Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation [CLASP TR] Early Feasibility Study [CLASP TR EFS]; NCT03745313)., Competing Interests: Funding Support and Author Disclosures This study was funded by Edwards Lifesciences. Dr Kodali has served as a consultant for Admedus, TriCares, TriFlo, X-Dot, MicroInterventional 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. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; has received institutional consulting contracts, for which she has received no direct compensation, from Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; has held stock options with Navigate; and has served as Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she has received no direct industry compensation. Dr Davidson has received research grant funding from Edwards Lifesciences; and has served as a consultant for Edwards Lifesciences. Dr Greenbaum has received proctor honoraria from Edwards Lifesciences. Dr Zahr has served as a consultant for Medtronic and Edwards Lifesciences. Dr Chadderdon has served as a consultant for Edwards Lifesciences and Medtronic. Dr Smith has received institutional grant support from Edwards Lifesciences, Abbott, and Artivion; has served as a speaker for Edwards Lifesciences, Abbott, Artivion, and Medtronic; and has served on the advisory board for Edwards Lifesciences. Dr Grayburn has received research grants from Abbott, Edwards Lifesciences, Medtronic, W.L. Gore & Associates, Neochord, and Cardiovalve; and has served as a consultant or on the advisory board for Abbott, Edwards Lifesciences, Medtronic, and 4C Medical. Dr. Marcoff has served as a member of a cardiovascular core laboratory that has contracts with Edwards Lifesciences and Abbott, for which he has received no direct compensation. Dr Whisenant has served as a consultant for Edwards Lifesciences. Dr Makkar has received research grants from Abbott and Edward Lifesciences; and has served as a consultant for Cordis and Medtronic. Dr Makar has served as a consultant for Abbott Vascular and Boston Scientific. Dr O’Neill has served as a consultant for Edwards Lifesciences. Dr Wang has served as a consultant for Edwards Lifesciences, Abbott Vascular, Boston Scientific, Materialise, and Neochord; and has received research grant support from Boston Scientific assigned to employer Henry Ford Health System. Dr Gray has served as a consultant for Edwards Lifesciences. Dr Hermiller has served as a consultant for Edwards Lifesciences. Dr Mitchel has received echocardiography education with Abbott. Dr Lim has received institutional research grants from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic; and has received consulting fees from Venus Medtech and W.L. Gore & Associates. Dr Williams has received research funding from Edwards Lifesciences and Medtronic. Dr Mack has served as a co-principal investigator for Edwards Lifesciences and Abbott trials; and has served as a study chair for Medtronic. Dr Leon has received instructional research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023. Published by Elsevier Inc.)

Background: Mitral valve transcatheter edge-to-edge repair is safe and effective in treating degenerative mitral regurgitation (DMR) patients at prohibitive surgical risk, but outcomes in complex mitral valve anatomy patients vary., Objectives: The PASCAL IID registry assessed safety, echocardiographic, and clinical outcomes with the PASCAL system in prohibitive risk patients with significant symptomatic DMR and complex mitral valve anatomy., Methods: Patients in the prospective, multicenter, single-arm registry had 3+ or 4+ DMR, were at prohibitive surgical risk, presented with complex anatomic features based on the MitraClip instructions for use, and were deemed suitable for the PASCAL system by a central screening committee. Enrolled patients were treated with the PASCAL system. Safety, effectiveness, and functional and quality-of-life outcomes were assessed. Study oversight also included an echocardiographic core laboratory and clinical events committee., Results: The study enrolled 98 patients (37.2% ≥2 independent significant jets, 15.0% severe bileaflet/multi scallop prolapse, 13.3% mitral valve orifice area <4.0 cm 2 , and 10.6% large flail gap and/or large flail width). The implant success rate was 92.9%. The 30-day composite major adverse event rate was 11.2%. At 6 months, 92.4% patients achieved MR ≤2+ and 56.1% achieved MR ≤1+ (P < 0.001 vs baseline). The Kaplan-Meier estimates for survival, freedom from major adverse events, and heart failure hospitalization at 6 months were 93.7%, 85.6%, and 92.6%, respectively. Patients experienced significant symptomatic improvement compared with baseline (P < 0.001)., Conclusions: The outcomes of the PASCAL IID registry establish the PASCAL system as a useful therapy for prohibitive surgical risk DMR patients with complex mitral valve anatomy. (PASCAL IID Registry within the Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial [CLASP IID] NCT03706833)., Competing Interests: Funding Support and Author Disclosures The PASCAL IID registry is funded by Edwards Lifesciences. Dr Hausleiter is a consultant and receives speaker honoraria and institutional research support from Edwards Lifesciences. Dr Lim is a consultant for Philips, Venus, and Valgen; and has received research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Gillam is a consultant for Philips, Bracco, and Edwards Lifesciences; and directs an echocardiography core laboratory for Abbott, Edwards Lifesciences, and Medtronic, for which she receives no direct compensation. Dr Zahr is a consultant for and receives research grants from Edwards Lifesciences. Dr Chadderdon is an educational consultant for Edwards Lifesciences and Medtronic. Dr Makkar is a consultant for and receives research grants from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific. Dr Goldman has provided minimally invasive mitral valve observation for Edwards Lifesciences. Dr Rudolph has received research grants from Edwards Lifesciences, Abbott, and Boston Scientific. Dr Hermiller is a consultant and proctor for Edwards Lifesciences. Dr Dhoble is a consultant and proctor for Edwards Lifesciences and Abbott. Dr Smalling receives clinical trial grant support from Edwards Lifesciences, Medtronic, and Abbott; and serves as a consultant for Abbott. Dr Latib is a consultant and serves on the advisory board for Boston Scientific, Edwards Lifesciences, Medtronic, Abbott, and Philips. Dr Kodali is a consultant for Admedus, Dura Biotech, TriCares, Phillips, and TriFlo; receives institutional research funding from Edwards Lifesciences, Medtronic, Abbott, Boston Scientific, and JenaValve; and serves on the scientific advisory for and has received equity from Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve Inc, Supira, Admedus, TriFlo, Adona, Tioga, and X-Dot. Dr Lurz receives institutional grants from Edwards Lifesciences, Abbott, and ReCor. Dr O’Neill is a consultant for Abiomed, BSCI, and Abbott; and was previously a consultant (expired) for Edwards Lifesciences. Dr Laham is a speaker for Abbott, Edwards Lifesciences, and Medtronic. Dr Kar is a consultant for Abbott, Medtronic, Boston Scientific, WL Gore, Laminar, Intershunt, and V wave; receives institutional research grants from Abbott, Medtronic, Boston Scientific, Edwards Lifesciences, and Highlife; is the co-national principal investigator for the REPAIR MR trial and EXPAND registry; is the co-national principal investigator for the PINNACLE FLX trial and CHAMPION trial; serves on the steering committee for the Triluminate Trial; and is an executive committee member for the RELIEVE HF trial. Dr Schofer receives travel support from Edwards Lifesciences and Abbott/St Jude Medical; has received speaking honoraria from Edwards Lifesciences and Boston Scientific; and is a consultant for Edwards Lifesciences and Abbott. Dr Inglessis-Azuaje is a proctor and serves as a lecturer for Edwards Lifesciences; is a consultant and proctor for Medtronic; and is a lecturer for Boston Scientific. Dr Baldus receives research funding from Abbott; and has received lecturing fees from Edwards Lifesciences, Abbott and Medtronic. Dr Koulogiannis is a consultant and advisory board member for Edwards Lifesciences; and is a speaker for Abbott. Dr Marcoff serves as a member of the echocardiography core laboratory for Edwards Lifesciences and Abbott, for which he receives no direct compensation. Dr Smith is on the CLASP IID trial leadership team and receives institutional grant and travel support for device evaluation from Edwards Lifesciences; receives institutional grants from Artivion; and received honoraria for speaking from Artivion and Medtronic. Dr Rodés-Cabau receives institutional research grants and speaker fees from Edwards Lifesciences. Dr Whisenant is a consultant for Edwards Lifesciences and Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Severe symptomatic degenerative mitral regurgitation (DMR) has a poor prognosis in the absence of treatment, and new transcatheter options are emerging., Objectives: The CLASP IID (Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial) randomized trial (NCT03706833) is the first to evaluate the safety and effectiveness of the PASCAL system compared with the MitraClip system in patients with significant symptomatic DMR. This report presents the primary safety and effectiveness endpoints for the trial., Methods: Patients with 3+ or 4+ DMR at prohibitive surgical risk were assessed by a central screening committee and randomized 2:1 (PASCAL:MitraClip). Study oversight also included an echocardiography core laboratory and a clinical events committee. The primary safety endpoint was the composite major adverse event rate at 30 days. The primary effectiveness endpoint was the proportion of patients with mitral regurgitation (MR) ≤2+ at 6 months., Results: A prespecified interim analysis in 180 patients demonstrated noninferiority of the PASCAL system vs the MitraClip system for the primary safety and effectiveness endpoints of major adverse event rate (3.4% vs 4.8%) and MR ≤2+ (96.5% vs 96.8%), respectively. Functional and quality-of-life outcomes significantly improved in both groups (P < 0.05). The proportion of patients with MR ≤1+ was durable in the PASCAL group from discharge to 6 months (PASCAL, 87.2% and 83.7% [P = 0.317 vs discharge]; MitraClip, 88.5% and 71.2% [P = 0.003 vs discharge])., Conclusions: The CLASP IID trial demonstrated safety and effectiveness of the PASCAL system and met noninferiority endpoints, expanding transcatheter treatment options for prohibitive surgical risk patients with significant symptomatic DMR., Competing Interests: Funding Support and Author Disclosures The CLASP IID trial is funded by Edwards Lifesciences. Dr Lim is a consultant for Philips, Venus, and Valgen; and has received research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Smith is on the CLASP IID trial leadership team; has received institutional grant and travel support for device evaluation from Edwards Lifesciences; has received institutional grants from Artivion; and has received speaker honoraria from Artivion and Medtronic. Dr Gillam is a consultant for Philips, Bracco, and Edwards Lifesciences; and directs an echocardiography core laboratory for Abbott, Edwards Lifesciences, and Medtronic for which she has received no direct compensation. Dr Zahr is a consultant for and has received research and educational grants from Edwards Lifesciences. Dr Chadderdon is an educational consultant for Edwards Lifesciences and Medtronic. Dr Makkar is a consultant for and has received research grants from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific. Dr von Bardeleben is a principal investigator for phase 3, postmarket clinical trials and investigator-initiated trials (Reshape II HF, TENDER, EuroSMR, and other registries) for Abbott, Daiichi-Sankyo, Edwards Lifesciences, Medtronic, NeoChord, Philips, and Siemens. Dr Szerlip is a proctor and speaker for Edwards Lifesciences; serves as a national principal investigator for an early feasibility study; is on the advisory board and serves as a proctor for Abbott; is part of the steering committee for Medtronic; and is a speaker for Boston Scientific. Dr Goldman is involved in minimally invasive mitral valve observation for Edwards Lifesciences. Dr Inglessis-Azuaje is a proctor and serves as a lecturer for Edwards Lifesciences; is a consultant and proctor for Medtronic; and is a lecturer for Boston Scientific. Dr Yadav is a consultant and speaker for Edwards Lifesciences, Abbott, Dasi Simulations, and Shockwave Medical. Dr Lurz has received institutional grants from Edwards Lifesciences, Abbott, and ReCor. Dr Davidson is a consultant for and has received research grant support from Edwards Lifesciences. Dr Mumtaz is a consultant and proctor for and has received honoraria and research support from Edwards Lifesciences, Abbott, Medtronic, JOMDD, Teleflex, and Atricure. Dr Gada is a consultant for Medtronic, Boston Scientific, Abbott, and Becton Dickinson. Dr Kar is a consultant for Abbott, Medtronic, Boston Scientific, W.L. Gore, Laminar, Intershunt, and V-Wave; has received institutional research grants from Abbott, Medtronic, Boston Scientific, Edwards Lifesciences, and Highlife; is the co–national principal investigator for the REPAIR MR trial and EXPAND registry and co–national principal investigator for the PINNACLE FLX trial and CHAMPION trial; and serves on the steering committee for the Triluminate trial and is an executive committee member for the RELIEVE HF trial. Dr Kodali is a consultant for and has received honoraria from Admedus, Dura Biotech, TriCares, Phillips and TriFlo; has received institutional research funding from Edwards Lifesciences, Medtronic, Abbott, Boston Scientific and JenaValve; serves on the scientific advisory board for and has received equity from Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve, Supira, Admedus, TriFlo, Adona, Tioga, and X-Dot. Dr Laham is a speaker for and has received compensation from Abbott, Edwards Lifesciences, and Medtronic. Dr Fam is a consultant for Edwards Lifesciences and Abbott. Dr Keßler has received speaker honoraria from Edwards Lifesciences and Abbott. Dr O’Neill is a consultant for Abiomed, Boston Scientific, and Abbott; and was previously a consultant (expired) for Edwards Lifesciences. Dr Whisenant is a consultant for Edwards Lifesciences and Abbott. Dr Kliger is a consultant for and has received speaker honoraria from Edwards Lifesciences, Medtronic, and Siemens. Dr Rudolph has received research grants from Edwards Lifesciences, Abbott, and Boston Scientific. Dr Hermiller is a consultant and proctor for Edwards Lifesciences. Dr Morse is a consultant for Edwards Lifesciences. Dr Schofer has received travel support from Edwards Lifesciences and Abbott/St. Jude Medical; and has received speaker honoraria from Edwards Lifesciences and Boston Scientific. Dr Latib is a consultant and serves on advisory boards for Boston Scientific, Edwards Lifesciences, Medtronic, Abbott, and Philips. Dr Koulogiannis is a consultant and advisory board member for Edwards Lifesciences; and is a speaker for Abbott. Dr Marcoff serves as a member of the echocardiography core laboratory for Edwards Lifesciences and Abbott, for which he has received no direct compensation. Dr Hausleiter is a consultant for and has received speaker honoraria and institutional research support from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Many novel percutaneous interventions are being developed for application in the tricuspid valve position. At the present time in the United States, there are no commercially available transcathter devices for this application. This article reviews the growing evidence for diagnosing, imaging, and treating severe tricuspid regurgitation as well as the surgical and transcatheter options that are under current development and in various stages of clinical trials., (© 2022 Wiley Periodicals LLC.)

Competing Interests: The authors report no conflict of interest.

Objectives: The TRISCEND study (Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy after Replacement of Tricuspid Valve with Transcatheter Device) is evaluating the safety and performance of transfemoral transcatheter tricuspid valve replacement in patients with clinically significant tricuspid regurgitation (TR) and elevated surgical risk., Background: Transcatheter valve replacement could lead to a paradigm shift in treating TR and improving patient quality of life., Methods: In the prospective, single-arm, multicenter TRISCEND study, patients with symptomatic moderate or greater TR, despite medical therapy, underwent percutaneous transcatheter tricuspid valve replacement with the EVOQUE system. A composite rate of major adverse events, echocardiographic parameters, and clinical, functional, and quality-of-life measures were assessed at 30 days., Results: Fifty-six patients (mean age of 79.3 years, 76.8% female, 91.1% TR severe or greater, 91.1% atrial fibrillation, and 87.5% New York Heart Association functional class III or IV) were treated. At 30 days, TR was reduced to mild or less in 98%. The composite major adverse events rate was 26.8% at 30 days caused by 1 cardiovascular death in a patient with a failed procedure, 2 reinterventions after device embolization, 1 major access site or vascular complication, and 15 severe bleeds, of which none were life-threatening or fatal. No myocardial infarction, stroke, renal failure, major cardiac structural complications, or device-related pulmonary embolism were observed. New York Heart Association significantly improved to functional class I or II (78.8%; P < 0.001), 6-minute walk distance improved 49.8 m (P < 0.001), and Kansas City Cardiomyopathy Questionnaire score improved 19 points (P < 0.001)., Conclusions: Early experience with the transfemoral EVOQUE system in patients with clinically significant TR demonstrated technical feasibility, acceptable safety, TR reduction, and symptomatic improvement at 30 days. The TRISCEND II randomized trial (NCT04482062) is underway., Competing Interests: Funding Support and Author Disclosures This work was funded by Edwards Lifesciences. Dr Kodali has received research support from Edwards Lifesciences, Medtronic, Boston Scientific, JenaValve, and Abbott Vascular; has received honoraria from Admedus, TriFlo, and Dura Biotech; and has served on the advisory board and received equity from MicroInterventional Devices, Dura Biotech, Supira, Adona Medical, Thubrikar Aortic Valve, Inc, and TriFlo. Dr Hahn has received speaker fees from Abbott Structural, Edwards Lifesciences, and Philips Healthcare; has received institutional educational and consulting contracts for which she receives no direct compensation from Abbott Structural, Boston Scientific, Edwards Lifesciences, and Medtronic; owns equity in 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 George has served as a consultant for CardioMech, Vdyne, Durvena, MITRx, Neptune Medical, Johnson and Johnson, Atricure, and Mitre Medical. Dr Wang has served a consultant for Edwards Lifesciences, Abbott, Boston Scientific, and Neochord; and has received research grant support from Boston Scientific assigned to her employer, the Henry Ford Health System. Dr Elmariah has received institutional research support from Edwards Lifesciences, Medtronic, and Abbott; and has received consulting fees from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022. Published by Elsevier Inc.)