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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: 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.)

Secondary mitral regurgitation (SMR) is associated with increased mortality and heart failure hospitalizations. The management of heart failure patients with SMR is complex and requires a multidisciplinary Heart Team approach. Guideline-directed medical therapies remain fundamental, yet in a proportion of patients SMR persists. In the past decade, transcatheter edge-to-edge repair (TEER) has been shown to improve survival in patients with SMR who remain symptomatic despite medical therapy. Technical advancements across newer generations of devices, improved imaging, and greater operator expertise have collectively contributed to the increased safety and efficacy of this procedure over time. Various emerging transcatheter mitral valve repair and replacement devices are currently under investigation and may offer superior, complementary or synergistic treatment options in patients ineligible for TEER. This review provides a state-of-the-art overview regarding the diagnosis of SMR, and currently available transcatheter mitral valve interventions and describes a contemporary approach to the management of SMR., Competing Interests: Conflicts of interest statement Dr. Safi is a speaker for Medtronic and Abbott. Dr. Tang has received speaker's honoraria and served as a physician proctor, consultant, advisory board member, TAVR publications committee member, APOLLO trial screening committee member and IMPACT MR steering committee member for Medtronic, has received speaker's 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, a consultant for NeoChord, Shockwave Medical, Peija Medical and Shenqi Medical Technology, and has received speaker's honoraria from Siemens Healthineers. Dr. Sharma has received speaker's bureau fees from Abbott Vascular, Boston Scientific, and Cardiovascular Systems. Dr. Khera is a consultant and proctor for Medtronic, consultant and proctor for Abbott Structural Heart, consultant for Terumo and W. L. Gore & Associates, consultant and advisory board member of EastEnd Medical, and serves on the speaker's bureau for Zoll Medical and Edwards Lifesciences. Dr. Pinney reports receiving consulting fees from: Abbott, ADI, Ancora, BMS, CareDx, Cordio, Impulse Dynamics, Medtronic, Nuwellis, Procyrion, Restore Medical, Transmedics, Valgen Medtech. The remaining authors have nothing to disclose., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Patients with mitral regurgitation (MR) and morphologic presence of relevant mitral annular calcification (MAC) represent a challenging phenotypic subset with limited treatment options., Objectives: The aim of this study was to assess the feasibility of transcatheter mitral valve replacement (TMVR) using dedicated devices for the treatment of MAC patients., Methods: Consecutive patients with symptomatic MR receiving TMVR and with available computed tomography data from the CHOICE-MI (Choice of Optimal Transcatheter Treatment for Mitral Insufficiency) multicenter registry were stratified by the presence of none or mild mitral annular calcification (MAC none/mild ) vs moderate or severe mitral annular calcification (MAC mod/sev )., Results: Among 279 eligible patients (median age = 76.0 years [Q1-Q3: 71.0-81.0 years], EuroSCORE II = 6.2% [Q1-Q3: 3.9%-12.1%]), 222 (79.6%) presented with MAC none/mild and 57 (20.4%) with MAC mod/sev . Patients with MAC mod/sev  had a higher prevalence of extracardiac arteriopathy (P = 0.011) and primary MR (P < 0.001). Although the technical success rate and the extent of MR elimination did not differ, TMVR treatment in MAC mod/sev patients was associated with higher rates of postprocedural bleeding complications (P = 0.02) and renal failure (P < 0.001). Functional improvement at the 1- and 2-year follow-up did not differ between groups. At the 2-year follow-up, there were no differences between patients with MAC mod/sev and MAC none/mild regarding all-cause mortality (38.5% vs 37.7%; P = 0.76), cardiovascular mortality (21.3% vs 24.9%; P = 0.97), and all-cause mortality or heart failure hospitalization (52.4% vs 46.7%; P = 0.28) CONCLUSIONS: TMVR in patients with MAC mod/sev is associated with higher rates of postprocedural complications but similar rates of survival, MR resolution, and functional improvement compared to MAC none/mild . Further studies are necessary to define the role of dedicated TMVR devices in this population. (Choice of Optimal Transcatheter Treatment for Mitral Insufficiency Registry [CHOICE-MI]; NCT04688190)., Competing Interests: Funding Support and Author Disclosures This study was supported by a grant from the German Heart Foundation. Dr Coisne is a proctor for Abbott Vascular; and has received speaker fees for Abbot Vascular, Edwards Lifesciences, GE Healthcare, Merck Sharp & Dohme, and Pfizer. Dr Ludwig has received travel compensation from Edwards Lifesciences; has received honoraria from Bayer and Abbott; is a consultant for NVT; and was supported by a research grant from the German Heart Foundation. Dr Ali has received research grants from Medtronic and Edwards Lifesciences. Dr Duncan is a consultant for and has received honoraria from Abbott Laboratories, Edward Lifesciences, and Medtronic. Dr Kalbacher has received personal fees from Abbott, Edwards Lifesciences, Pi-Cardia Ltd, and Medtronic. Dr Rudolph has received speaker honoraria from Abbott Vascular. Dr Hausleiter has received consulting fees, speaker honoraria, and support of research projects paid to the institution from Abbott Vascular and Edwards Lifesciences. Dr Ruge serves as a physician proctor for Abbott and Edwards Lifesciences; is a consultant for Medtronic, Abbott, and Edwards Lifesciences; and is a member of the Abbott Advisory Board. Dr Schmidt has received consultant fees and travel support from Cardiovalve. Dr Taramasso is consultant or has received consultancy fees from Abbott, Edwards Lifesciences, Medtronic, Boston Scientific, Shenqi Medical, MEDIRA, PiCardia, CoreMedic, Cardiovalve, Simulands, CoreQuest, HiD Imaging, and OneCrea Medical. Dr Denti has received speaker honoraria from Abbott and Edwards Lifesciences; and has received consultant fees from Approxima, HVR, InnovHeart, and Pi-Cardia Ltd. Dr Andreas is a proctor, consultant, and speaker for Edwards Lifesciences, Abbott, Medtronic, Boston, and Zoll; and has received institutional research grants from Edwards Lifesciences, Abbott, Medtronic, and LSI. 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.)

Competing Interests: Funding Support and Author Disclosures Dr Tang has received speaker honoraria and has served as a physician proctor, consultant, Advisory Board member, TAVR Publications Committee member, APOLLO Trial Screening Committee member, and IMPACT MR Steering Committee member for Medtronic; has received speaker honoraria and has 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 for NeoChord, Shockwave Medical, Peija Medical, and Shenqi Medical Technology; and has received speaker honoraria from Siemens Healthineers. Dr Lerakis is a member of the Publication Imaging Subcommittee for the TRILUMINATE Pivotal Trial. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Background: The safety profile of transcatheter tricuspid valve (TTV) repair techniques is well established, but residual tricuspid regurgitation (TR) remains a concern., Objectives: The authors sought to assess the impact of residual TR severity post-TTV repair on survival., Methods: We evaluated the survival rate at 2 years of 613 patients with severe isolated functional TR who underwent TTV repair in TRIGISTRY according to the severity of residual TR at discharge using a 3-grade (mild, moderate, and severe) or 4-grade scheme (mild, mild to moderate, moderate to severe, and severe)., Results: Residual TR was none/mild in 33%, moderate in 52%, and severe in 15%. The 2-year adjusted survival rates significantly differed between the 3 groups (85%, 70%, and 44%, respectively; restricted mean survival time [RMST]: P = 0.0001). When the 319 patients with moderate residual TR were subdivided into mild to moderate (n = 201, 33%) and moderate to severe (n = 118, 19%), the adjusted survival rate was also significantly different between groups (85%, 80%, 55%, and 44%, respectively; RMST: P = 0.001). Survival was significantly lower in patients with moderate to severe residual TR compared to patients with mild to moderate residual TR (P = 0.006). No difference in survival rates was observed between patients with no/mild and mild to moderate residual TR (P = 0.67) or between patients with moderate to severe and severe residual TR (P = 0.96)., Conclusions: The moderate residual TR group was heterogeneous and encompassed patients with markedly different clinical outcomes. Refining TR grade classification with a more granular 4-grade scheme improved outcome prediction. Our results highlight the importance of achieving a mild to moderate or lower residual TR grade during TTV repair, which could define a successful intervention., Competing Interests: Funding Support and Author Disclosures Dr Dreyfus has received speaker or proctoring fees from Abbott. Dr Kresoja has received consulting fees from Edwards Lifesciences. Dr Taramasso has received consulting or speaker fees from Abbott Vascular, Edwards Lifesciences, Medtronic, Boston Scientific, Shenqi Medical, PiCardia, CoreMedic, VentriMend, MEDIRA, CoreQuest, and HiD Imaging. Dr Iliadis has received consulting fees from Abbott Vascular and Edwards Lifesciences. Dr Nombela-Franco has received consulting or speaker fees from Abbott Vascular, Edwards Lifesciences, and Products and Features. Dr Estevez-Loureiro has received speaker fees from Abbott Vascular, Edwards Lifesciences, Boston Scientific, and Venus Medtech. Dr Hausleiter has received grants and consulting fees from Edwards Lifesciences. Dr Stolz has received consulting or speaker fees from Edwards Lifesciences. Dr Windecker has received research, travel, or educational 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 & 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/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 served as a member of the Steering/Executive Committee Group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. Dr Zamorano has received consulting or speaker fees from Novartis, Bayer, and Pfizer. Dr von Bardeleben has received consulting or speaker fees from Abbott Vascular, Edwards Lifesciences, Medtronic, Philips, and Siemens. Dr Tang has received speaker honoraria and has served as a physician proctor, consultant, Advisory Board member, TAVR Publications Committee Member, APOLLO Trial Screening Committee Member, and IMPACT MR Steering Committee member for Medtronic; has received speaker honoraria and has 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 honoraria from Siemens Healthineers. Dr Hahn has received speaker fees from Boston Scientific, Edwards Lifesciences, and Philips Healthcare. Dr Webb has received consulting fees from Edwards Lifesciences; and has received research funding from Medtronic, Abbott, Boston Scientific, and Edwards Lifesciences. Dr Lauten has received speaker fees from Boehringer Ingelheim, Medtronic, Amgen, Bayer, Novartis, Sanofi, Chiesi, and AstraZeneca; and is a shareholder of the Devie Medical Drug Eluting Valve for Endocarditis Treatment. Dr Rodés-Cabau has received consulting or speaker fees from Abbott Vascular, Edwards Lifesciences, and Medtronic. Dr Nejjari has received consulting or speaker fees from Abbott Vascular, Medtronic, Edwards Lifesciences, Boston Scientific, and Robocath. Dr Badano has received consulting or speaker fees from Edwards Lifesciences, GE Healthcare, and Philips Medical Systems. Dr Himbert has received proctoring fees from Edwards Lifesciences and Abbott Vascular. Dr Modine has received speaker or consulting fees from Abbott, Edwards Lifesciences, Medtronic, Microport, and GE. Dr Rudolph has received consulting or speaker fees from Abbott Vascular and Edwards Lifesciences. Dr Bax has received lecture fees from Abbott and Edwards Lifesciences. Dr Lurz has received consulting fees from Abbott Medical, Innoventric, and Edwards Lifesciences. Dr Maisano has received grant and/or research institutional support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific Corporation, NVT, Terumo, Venus, and 3mensio; has received consulting fees and personal and institutional honoraria from Abbott, Medtronic, Edwards Lifesciences, Xeltis, Cardiovalve, Occlufit, Simulands, Mtex, Venus, and Squadra; has received royalty income/IP rights from Edwards Lifesciences; and is a shareholder (including share options) in Cardiogard, Cardiovalve, Magenta, SwissVortex, Transseptalsolutions, and 4Tech. Dr Messika-Zeitoun has received research grants from Edwards Lifesciences. 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: Whether transcatheter mitral valve replacement (TMVR) devices perform similarly with respect to the underlying mitral regurgitation (MR) etiology remains unknown. The aim of the present analysis was to assess outcomes of TMVR according to the MR underlying etiology among the CHoice of OptImal transCatheter trEatment for Mitral Insufficiency (CHOICE-MI) registry., Methods: Of 746 patients, 229 patients (30.7%) underwent TMVR. The study population was subdivided according to primary, secondary, or mixed MR. Patients with mitral annular calcification were excluded. The primary study endpoint was a composite endpoint of all-cause mortality or hospitalization for heart failure at 1 year. Secondary study endpoints were all-cause and cardiovascular mortality at 1 year, New York Heart Association functional class, and residual MR, both at discharge and 1 year., Results: The predominant MR etiology was secondary MR (58.4%), followed by primary MR (28.7%) and mixed MR (12.9%). Technical success and procedural mortality were similar according to MR etiology. Discharge echocardiography revealed residual MR 2+ in 11.3%, 3.7%, and 5.3% of patients with primary, secondary, and mixed MR, respectively (P = .1). MR elimination was similar in all groups up to the 1-year follow-up. There was no difference in terms of primary combined outcome occurrence according to MR etiology. One-year all-cause mortality was reported in 28.8%, 24.2%, and 32.1% of patients with primary, secondary, and mixed MR, respectively (P = .07)., Conclusions: In our study we did not find differences in short-term and 1-year outcomes after TMVR according to MR etiology., (Copyright © 2024 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Scarce data exist on patients with previous left valve surgery (PLVS) undergoing transcatheter tricuspid valve intervention (TTVI). This study sought to investigate the procedural and early outcomes in patients with PLVS undergoing TTVI., Methods: This was a subanalysis of the multicenter TriValve registry including 462 patients, 82 (18%) with PLVS. Data were analyzed according to the presence of PLVS in the overall cohort and in a propensity score-matched population including 51 and 115 patients with and without PLVS, respectively., Results: Patients with PLVS were younger (72 ± 10 vs 78 ± 9 years; p < 0.01) and more frequently female (67.1% vs 53.2%; P = 0.02). Similar rates of procedural success (PLVS 80.5%; no-PLVS 82.1%; P = 0.73), and 30-day mortality (PLVS 2.4%, no-PLVS 3.4%; P = 0.99) were observed. After matching, there were no significant differences in both all-cause rehospitalisation (PLVS 21.1%, no-PLVS 26.5%; P = 0.60) and all-cause mortality (PLVS 9.8%, no-PLVS 6.7%; P = 0.58). At last follow-up (median 6 [interquartile range 1-12] months after the procedure), most patients (81.8%) in the PLVS group were in NYHA functional class I-II (P = 0.12 vs no-PLVS group), and TR grade was ≤ 2 in 82.6% of patients (P = 0.096 vs no-PVLS group). A poorer right ventricular function and previous heart failure hospitalization determined increased risks of procedural failure and poorer outcomes at follow-up, respectively., Conclusions: In patients with PLVS, TTVI was associated with high rates of procedural success and low early mortality. However, about one-third of patients required rehospitalisation or died at midterm follow-up. These results would support TTVI as a reasonable alternative to redo surgery in patients with PLVS and suggest the importance of earlier treatment to improve clinical outcomes., (Copyright © 2021 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Background Edge-to-edge transcatheter mitral valve repair as salvage therapy in high surgical risk patients with severe mitral regurgitation presenting with cardiogenic shock (CS) has been described in small case series, but large clinical results have not been reported. This study aimed to evaluate outcomes of transcatheter mitral valve repair with MitraClip in patients with mitral regurgitation and CS using a large national database. Methods and Results From January 2014 to March 2019, we identified hospitalizations for CS in patients with mitral valve disease using data from Centers for Medicare and Medicaid Services. Those with a prior surgical or percutaneous mitral valve intervention were excluded. We compared survival between patients who underwent MitraClip during the index hospitalization and those who did not using propensity-matched analysis. The analysis included 38 166 patients (mean age, 71±11 years, 41.6% women) of whom 622 (1.6%) underwent MitraClip. MitraClip was increasingly used during CS hospitalizations over the study period ( P <0.001). After matching, patients receiving MitraClip had significantly lower in-hospital mortality (odds ratio, 0.6; 95% CI, 0.47-0.77; P <0.001) and 1-year mortality (hazard ratio, 0.76; 95% CI, 0.65-0.88; P <0.001) compared with those without MitraClip. The survival benefit associated with MitraClip was consistent across subgroups of interest, with the exception of patients requiring acute mechanical circulatory support or hemodialysis at index. Conclusions In patients with mitral regurgitation presenting with CS, use of MitraClip is increasing and associated with greater in-hospital and 1-year survival. Further studies are warranted to optimize patient selection and procedure timing for those receiving MitraClip as a treatment option in CS.

Mitral annular calcification with mitral valve disease is a challenging problem that could necessitate surgical mitral valve replacement (SMVR). Transcatheter mitral valve replacement (TMVR) is emerging as a feasible alternative in high-risk patients with appropriate anatomy. PubMed, Embase, and Cochrane Central Register of Controlled Trials were searched from inception to December 25, 2019 for studies discussing SMVR or TMVR in patients with mitral annular calcification; 27 of 1539 articles were selected for final review. TMVR was used in 15 studies. Relevant data were available on 82 patients who underwent hybrid transatrial TMVR, and 354 patients who underwent transapical or transseptal TMVR. Outcomes on SMVR were generally reported as small case series (447 patients from 11 studies); however, 1 large study recently reported outcomes in 9551 patients. Patients who underwent TMVR had a shorter median follow-up of 9 to 12 months (range, in-hospital‒19 months) compared with patients with SMVR (54 months; range, in-hospital‒120 months). Overall, those undergoing TMVR were older and had higher Society of Thoracic Surgeons risk scores. SMVR showed a wide range of early (0%-27%; median 6.3%) and long-term mortality (0%-65%; median at 1 year, 15.8%; 5 years, 38.8%, 10 years, 62.4%). The median in-hospital, 30-day, and 1-year mortality rates were 16.7%, 22.7%, and 43%, respectively, for transseptal/transapical TMVR, and 9.5%, 20.0%, and 40%, respectively, for transatrial TMVR. Mitral annular calcification is a complex disease and TMVR, with a versatile option of transatrial approach in patients with challenging anatomy, offers a promising alternative to SMVR in high-risk patients. However, further studies are needed to improve technology, patient selection, operative expertise, and long-term outcomes.

Bioprosthetic mitral structural valve degeneration and failed mitral valve repair (MVr) have traditionally been treated with reoperative mitral valve surgery. Transcatheter mitral valve-in-valve (MVIV) and valve-in-ring (MVIR) replacement are now feasible, but data comparing these approaches are lacking. We sought to compare the outcomes of (1) reoperative mitral valve replacement (redo-MVR) and MVIV for structural valve degeneration, and (2) reoperative mitral valve repair (redo-MVr) or MVR and MVIR for failed MVr. A literature search of PubMed, Embase, and the Cochrane Library was conducted up to July 31, 2020. Thirty-two studies involving 25 832 patients were included. Redo-MVR was required in ≈35% of patients after index surgery at 10 years, with 5% to 15% 30-day mortality. MVIV resulted in >95% procedural success with 30-day and 1-year mortality of 0% to 8% and 11% to 16%, respectively. Recognized complications included left ventricular outflow tract obstruction (0%-6%), valve migration (0%-9%), and residual regurgitation (0%-6%). Comparisons of redo-MVR and MVIV showed no statistically significant differences in mortality (11.3% versus 11.9% at 1 year, P =0.92), albeit higher rates of major bleeding and arrhythmias with redo-MVR. MVIR resulted in 0% to 34% mortality at 1 year, whereas both redo-MVr and MVR for failed repairs were performed with minimal mortality and durable long-term results. MVIV is therefore a viable alternative to redo-MVR for structural valve degeneration, whereas redo-MVr or redo-MVR is preferred for failed MVr given the suboptimal results with MVIR. However, not all patients will be candidates for MVIV/MVIR because anatomical restrictions may preclude transcatheter options from adequately addressing the underlying pathology.

Objectives: The aim of this study was to assess the clinical outcome of baseline massive or torrential tricuspid regurgitation (TR) after transcatheter tricuspid valve intervention (TTVI)., Background: The use of TTVI to treat symptomatic severe TR has been increasing rapidly, but little is known regarding the impact of massive or torrential TR beyond severe TR., Methods: The study population comprised 333 patients with significant symptomatic TR from the TriValve Registry who underwent TTVI. Mid-term outcomes after TTVI were assessed according to the presence of massive or torrential TR, defined as vena contracta width ≥14 mm. Procedural success was defined as patient survival after successful device implantation and delivery system retrieval, with residual TR ≤2+. The primary endpoint comprised survival rate and freedom from rehospitalization for heart failure, survival rate, and rehospitalization at 1 year., Results: Baseline massive or torrential TR and severe TR were observed in 154 patients (46.2%) and 179 patients (53.8%), respectively. Patients with massive or torrential TR had a higher prevalence of ascites than those with severe TR (27.3% vs. 20.4%, respectively; p = 0.15) and demonstrated a similar procedural success rate (83.2% vs. 77.3%, respectively; p = 0.21). The incidence of peri-procedural adverse events was low, with no significant between-group differences. Freedom from the composite endpoint was significantly lower in patients with massive or torrential TR than in those with severe TR, which was significantly associated with an increased risk for 1-year death of any cause or rehospitalization for heart failure (adjusted hazard ratio: 1.91; 95% confidence interval: 1.10 to 3.34; p = 0.022). Freedom from the composite endpoint was significantly higher in patients with massive or torrential TR when procedural success was achieved (69.9% vs. 54.2%, p = 0.048)., Conclusions: Baseline massive or torrential TR is associated with an increased risk for all-cause mortality and rehospitalization for heart failure 1 year after TTVI. Procedural success is related to better outcomes, even in the presence of baseline massive or torrential TR. (International Multisite Transcatheter Tricuspid Valve Therapies Registry [TriValve]; NCT03416166)., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to assess the value of echocardiographic right ventricular (RV) and systolic pulmonary artery pressure (sPAP) assessment in predicting transcatheter tricuspid edge-to-edge valve repair (TTVR) outcome., Background: RV dysfunction and pulmonary hypertension are associated with poor prognosis and are systematically sought during tricuspid regurgitation evaluation. The value of echocardiographic assessment in predicting TTVR outcome is unknown., Methods: Data were taken from the TriValve (Transcatheter Tricuspid Valve Therapies) registry, which includes patients undergoing TTVR at 14 European and North American centers. The primary outcome was 1-year survival free from hospitalization for heart failure, and secondary outcomes were 1-year survival and absence of hospital admission for heart failure at 1 year., Results: Overall, 249 patients underwent TTVR between June 2015 and 2018 (mean tricuspid annular plane systolic excursion [TAPSE] 15.8 ± 15.3 mm, mean sPAP 43.6 ± 16.0 mm Hg). Tricuspid regurgitation grade ≥3+ was found in 96.8% of patients at baseline and 29.4% at final follow-up; 95.6% were in New York Heart Association functional class III or IV initially, compared with 34.3% at follow-up (p < 0.05). Final New York Heart Association functional class did not differ among TAPSE and sPAP quartiles, even when both low TAPSE and high sPAP were present. Rates of 1-year survival and survival free from hospitalization for heart failure were 83.9% and 78.7%, respectively, without significant differences according to baseline echocardiographic RV characteristics (TAPSE, fractional area change, and end-diastolic area) and sPAP (p > 0.05 for all)., Conclusions: TTVR provides clinical improvement, with 1-year survival free from hospital readmission >75% in patients with severe tricuspid regurgitation. Conventional echocardiographic parameters used to assess RV function and sPAP did not predict clinical outcome after TTVR., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Transcatheter mitral valve repair (TMVR) has shown comparable outcomes to surgical mitral valve replacement or repair (SMVR) in patients who are at a higher risk of surgical complications and therefore are not amenable to surgery. Elderly patients are considered poor surgical candidates due to their advanced age, and presence of comorbidities. A sub-analysis of EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) trial identified patients of >70 years of age appear to have a similar risk-benefit profile for either approach of surgery or transcatheter. This finding does have some caveats considering the trial included surgical cohort with both repair and replacement. Utilizing the National Inpatient Sample, we identified a surgical cohort of ≥80 years of age that underwent mitral valve repair and used propensity matching to compare it with a similar cohort that underwent TMVR. In a well-balanced cohort, TMVR was associated with significantly lower in-patient mortality (0.7% vs 3.1%). TMVR was also associated with significantly decreased in-hospital complications such as acute kidney injury, cardiogenic shock, postoperative hemorrhage, transfusion, permanent pacemaker, and respiratory and vascular complications. Owing to this, the duration of hospital stay is approximately 6 days less with TMVR. Trend analysis has shown a paradigm shift in these elderly patients with 85% of all repairs in 2012 were performed surgically, whereas in 2016 almost 94% of all the repairs being performed via a transcatheter approach. In conclusion, in patients ≥80 years of age, the surgical MVR had 4-fold higher mortality compared to TMVR with higher cardiac, vascular, hemorrhagic and respiratory complications. Despite the limitations of being observational in nature, this data strongly supports the preferential use of the transcatheter approach for mitral valve repair in patients ≥80 years of age., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objectives: The interference of a transtricuspid cardiac implantable electronic device (CIED) lead with tricuspid valve function may contribute to the mechanism of tricuspid regurgitation (TR) and poses specific therapeutic challenges during transcatheter tricuspid valve intervention (TTVI). Feasibility and efficacy of TTVI in presence of a CIED is unclear., Background: Feasibility of TTVI in presence of a CIED lead has never been proven on a large basis., Methods: The study population consisted of 470 patients with severe symptomatic TR from the TriValve (Transcatheter Tricuspid Valve Therapies) registry who underwent TTVI at 21 centers between 2015 and 2018. The association of CIED and outcomes were assessed., Results: Pre-procedural CIED was present in 121 of 470 (25.7%) patients. The most frequent location of the CIED lead was the posteroseptal commissure (44.0%). As compared with patients without a transvalvular lead (no-CIED group), patients having a tricuspid lead (CIED group) were more symptomatic (New York Heart Association functional class III to IV in 95.9% vs. 92.3%; p = 0.02) and more frequently had previous episodes of right heart failure (87.8% vs. 69.0%; p = 0.002). No-CIED patients had more severe TR (effective regurgitant orifice area 0.7 ± 0.6 cm 2 vs. 0.6 ± 0.3 cm 2 ; p = 0.02), but significantly better right ventricular function (tricuspid annular plane systolic excursion = 16.7 ± 5.0 mm vs. 15.9 ± 4.0 mm; p = 0.04). Overall, 373 patients (79%) were treated with the MitraClip (Abbott Vascular, Santa Clara, California) (106 [87.0%] in the CIED group). Among them, 154 (33%) patients had concomitant transcatheter mitral repair (55 [46.0%] in the CIED group, all MitraClip). Procedural success was achieved in 80.0% of no-CIED patients and in 78.6% of CIED patients (p = 0.74), with an in-hospital mortality of 2.9% and 3.7%, respectively (p = 0.70). At 30 days, residual TR ≤2+ was observed in 70.8% of no-CIED and in 73.7% of CIED patients (p = 0.6). Symptomatic improvement was observed in both groups (NYHA functional class I to II at 30 days: 66.0% vs. 65.0%; p = 0.30). Survival at 12 months was 80.7 ± 3.0% in the no-CIED patients and 73.6 ± 5.0% in the CIED patients (p = 0.30)., Conclusions: TTVI is feasible in selected patients with CIED leads and acute procedural success and short-term clinical outcomes are comparable to those observed in patients without a transtricuspid lead., (Copyright © 2020 American College of Cardiology Foundation. All rights reserved.)

Objectives: The purpose of this study was to evaluate procedural and 1-year clinical and echocardiographic outcomes of patients treated with tricuspid edge-to-edge repair., Background: Transcatheter edge-to-edge repair has been successfully performed in selected patients with symptomatic tricuspid regurgitation (TR) and high risk for surgery, but outcome data are sparse., Methods: This analysis of the multicenter international TriValve (Transcatheter Tricuspid Valve Therapies) registry included 249 patients with severe TR treated with edge-to-edge repair in compassionate and/or off-label use. Clinical and echocardiographic outcomes were prospectively collected and retrospectively analyzed., Results: In 249 patients (mean age 77 ± 9 years; European System for Cardiac Operative Risk Evaluation II score 6.4% [interquartile range: 3.9% to 13.9%]), a successful procedure with TR reduction to grade ≤2+ was achieved in 77% by placement of 2 ± 1 tricuspid clips. Concomitant treatment of severe TR and mitral regurgitation was performed in 52% of patients. At 1-year follow-up, significant and durable improvements in TR severity (TR ≤2+ in 72% of patients) and New York Heart Association functional class (≤II in 69% of patients) were observed. All-cause mortality was 20%, and the combined rate of mortality and unplanned hospitalization for heart failure was 35%. Predictors of procedural failure included effective regurgitant orifice area, tricuspid coaptation gap, tricuspid tenting area, and absence of central or anteroseptal TR jet location. Predictors of 1-year mortality were procedural failure, worsening kidney function, and absence of sinus rhythm., Conclusions: Transcatheter tricuspid edge-to-edge repair can achieve TR reduction at 1 year, resulting in significant clinical improvement. Predictors of procedural failure and 1-year mortality identified here may help select patients who will benefit most from this therapy., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to evaluate the predictors of left ventricular outflow tract (LVOT) obstruction after transcatheter mitral valve replacement (TMVR)., Background: LVOT obstruction is a major concern with TMVR, but limited data exist regarding its predictors and impact on outcomes., Methods: Patients with pre-procedural multidetector row computed tomography (MDCT) undergoing TMVR for failed mitral bioprosthetic valves (valve-in-valve), annuloplasty rings (valve-in-ring), and mitral annular calcification (valve-in-MAC) were included in this study. Echocardiographic and procedural characteristics were recorded, and comprehensive assessment with MDCT was performed to identify the predictors of LVOT obstruction (defined as an increment of mean LVOT gradient ≥10 mm Hg from baseline). The new LVOT (neo-LVOT) area left after TMVR was estimated by embedding a virtual valve into the mitral annulus on MDCT, simulating the procedure., Results: Among 194 patients with pre-procedural MDCT undergoing TMVR (valve-in-valve, 107 patients; valve-in-ring, 50 patients; valve-in-MAC, 37 patients), LVOT obstruction was observed in 26 patients (13.4%), with a higher rate after valve-in-MAC than valve-in-ring and valve-in-valve (54.1% vs. 8.0% vs. 1.9%; p < 0.001). Patients with LVOT obstruction had significantly higher procedural mortality compared with those without LVOT obstruction (34.6% vs. 2.4%; p < 0.001). Receiver-operating characteristic curve analysis showed that an estimated neo-LVOT area ≤1.7 cm 2 predicted LVOT obstruction with sensitivity of 96.2% and specificity of 92.3%., Conclusions: LVOT obstruction after TMVR was associated with higher procedural mortality. A small estimated neo-LVOT area was significantly associated with LVOT obstruction after TMVR and may help identify patients at high risk for LVOT obstruction., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: A large, prospective international registry was developed to evaluate the initial clinical applications of transcatheter tricuspid valve intervention (TTVI) with different devices., Background: TTVI for native tricuspid valve dysfunction has been emerging during the last few years as an alternative therapeutic option to serve a large high-risk population of patients with severe symptomatic tricuspid regurgitation (TR)., Methods: The TriValve Registry included 312 high-risk patients with severe TR (76.4 ± 8.5 years of age; 57% female; EuroSCORE II 9 ± 8%) at 18 centers. Interventions included repair at the level of the leaflets (MitraClip, Abbott Vascular, Santa Clara, California; PASCAL Edwards Lifesciences, Irvine, California), annulus (Cardioband, Edwards Lifesciences; TriCinch, 4tech, Galway, Ireland; Trialign, Mitraling, Tewksbury, Massachusetts), or coaptation (FORMA, Edwards Lifesciences) and replacement (Caval Implants, NaviGate, NaviGate Cardiac Structures, Lake Forest, California). Clinical outcomes were prospectively determined during mid-term follow-up., Results: A total of 108 patients (34.6%) had prior left heart valve intervention (84 surgical and 24 transcatheter, respectively). TR etiology was functional in 93%, and mean annular diameter was 46.9 ± 9 mm. In 75% of patients the regurgitant jet was central (vena contracta 1.1 ± 0.5; effective regurgitant orifice area 0.78 ± 0.6 cm 2 ). Pre-procedural systolic pulmonary artery pressure was 41 ± 14.8 mm Hg. Implanted devices included: MitraClip in 210 cases, Trialign in 18 cases, TriCinch first generation in 14 cases, caval valve implantation in 30 cases, FORMA in 24 cases, Cardioband in 13 cases, NaviGate in 6 cases, and PASCAL in 1. In 64% of the cases, TTVI was performed as a stand-alone procedure. Procedural success (defined as the device successfully implanted and residual TR ≤2+) was 72.8%. Greater coaptation depth (odds ratio: 24.1; p = 0.002) was an independent predictor of reduced device success. Thirty-day mortality was 3.6% and was significantly lower among patients with procedural success (1.9% vs. 6.9%; p = 0.04); Actuarial survival at 1.5 years was 82.8 ± 4% and was significantly higher among patients who had procedural success achieved., Conclusions: TTVI is feasible with different technologies, has a reasonable overall procedural success rate, and is associated with low mortality and significant clinical improvement. Mid-term survival is favorable in this high-risk population. Greater coaptation depth is associated with reduced procedural success, which is an independent predictor of mortality., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: We report our multicenter experience on continuous hemodynamic monitoring using exclusively the steerable guide catheter (SGC) during MitraClip repair., Background: Left atrial pressure (LAP) and V-wave are useful to evaluate MitraClip repair but no simple method of continuous monitoring exists., Methods: From 11/2016 to 8/2017, 74 patients from four centers with symptomatic moderate-severe to severe mitral regurgitation (MR), underwent MitraClip NT repair with continuous hemodynamic monitoring via the SGC. Real-time LAP/V-wave changes were compared with transesophageal echocardiography (TEE). When mitral stenosis was suspected, transmitral gradients were verified by invasive hemodynamics. Clinical and echocardiographic outcomes were determined., Results: Mean age was 78 ± 10 years and STS score 9.1 ± 11.0%. Pathology included leaflet prolapse/flail (45%), restriction (35%), and mixed (20%). Number of clips averaged 1.7 ± 0.7 per case. There was a significant reduction in LAP (21 ± 10 to 15 ± 7 mmHg, P < 0.0001) and V-wave(37 ± 19 to 24 ± 10 mmHg, P < 0.0001) post MitraClip, but the decrease was less in patients with atrial fibrillation (P < 0.05). Transmitral gradient significantly increased from 2.0 ± 1.2 to 4.0 ± 1.7 mmHg (P < 0.0001). Paradoxical increases in LAP and V-wave despite MR reduction were observed in three cases requiring MitraClip repositioning or retrieval to avoid stenosis. Follow-up averaged 5.0 ± 2.9 months and was 100% complete. KCCQ improvement was significant and MR reduction to <1+ was 67% and <2+ was 93% at 30 days., Conclusions: Continuous hemodynamic monitoring using the SGC complements TEE to assess and optimize MitraClip repair in real-time. Further validation is necessary but this feature may be part of future MitraClip and other transcatheter mitral repair systems., (© 2018 Wiley Periodicals, Inc.)

Symptomatic severe tricuspid regurgitation (TR), if untreated, carries a dismal prognosis. These patients are at very high risk for surgical repair or replacement and transcatheter options to treat TR are emerging. More than 300 transcatheter tricuspid repairs with the MitraClip system have been performed worldwide with promising results. The TriClip system, with the MitraClip NT delivered via a dedicated tricuspid steerable guide catheter, is currently under investigation. This article describes the step-by-step technique on using the MitraClip system to perform transcatheter tricuspid repair using echocardiographic and fluoroscopic guidance. The latest data on worldwide experience with tricuspid clipping are also discussed., (Copyright © 2017 Elsevier Inc. All rights reserved.)