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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 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.)

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: Valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) is increasingly used to treat degenerated surgical bioprostheses. Bioprosthetic valve fracture (BVF) has been shown to improve hemodynamic status in VIV TAVR in case series. However, the safety and efficacy of BVF are unknown., Objectives: The primary objective of this study was to assess the safety and efficacy of VIV TAVR using SAPIEN 3 and SAPIEN 3 Ultra valves with or without BVF using data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry., Methods: The primary outcome was in-hospital mortality. Secondary outcomes included echocardiography-derived valve gradient and aortic valve area. Inverse probability of treatment weighting was used to adjust for baseline characteristics., Results: A total of 2,975 patients underwent VIV TAVR from December 15, 2020, to March 31, 2022. BVF was attempted in 619 patients (21%). In adjusted analyses, attempted BVF was associated with higher in-hospital mortality (OR: 2.51; 95% CI: 1.30-4.84) and life-threatening bleeding (OR: 2.55; 95% CI: 1.44-4.50). At discharge, VIV TAVR with attempted BVF was associated with larger aortic valve area (1.6 cm 2 vs 1.4 cm 2 ; P < 0.01) and lower mean gradient (16.3 mm Hg vs 19.2 mm Hg; P < 0.01). When BVF was compared with no BVF according to timing (before vs after transcatheter heart valve implantation), BVF after transcatheter heart valve implantation was associated with improved hemodynamic status and similar mortality., Conclusions: BVF as an adjunct to VIV TAVR with the SAPIEN 3 and SAPIEN 3 Ultra valves is associated with a higher risk for in-hospital mortality and significant bleeding and modest improvements in echocardiography-derived hemodynamic status. The timing of BVF is an important determinant of safety and efficacy., Competing Interests: Funding Support and Author Disclosures No funding was obtained for this study. Statistical support was provided by Edwards Lifesciences. The views or opinions presented here do not represent those of the American College of Cardiology, the STS, or the STS/ACC TVT Registry. Dr Chhatriwalla is a member of the Speakers Bureau of Abbott Vascular, Edwards Lifesciences, and Medtronic; is a proctor for Edwards Lifesciences and Medtronic; and has received research support from Boston Scientific. Dr Allen is a proctor and Speakers Bureau member for Abbott Vascular, Edwards Lifesciences, and Medtronic; and has received research grant support from Boston Scientific (all payments to institution). Dr Depta is a consultant and/or advisory board member for Edwards Lifesciences, Boston Scientific, W.L. Gore & Associates, Abbott, Medtronic, and V-Wave. Dr Garcia is a proctor for Edwards Lifesciences; has received research support from Edwards Lifesciences, Medtronic, and Boston Scientific; is a consultant for Boston Scientific, Medtronic, and Edwards Lifesciences; and is supported by the Harold C. Schott Foundation Endowed Chair for Structural and Valvular Heart Disease. Dr Whisenant is a consultant for Edwards Lifesciences and Medtronic. Dr Thourani is an advisor or does research with Abbott Vascular, Artivion, Atricure, Boston Scientific, Edwards Lifesciences, Jenavalve, Medtronic, and Shockwave. Dr Zahr is a consultant for Edwards Lifesciences and Medtronic. Dr Rodriguez is a consultant or receives research support from Abbott Vascular, Atricure, Boston Scientific, Edwards Lifesciences, and Cardiomech., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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.)

Purpose of Review: In this review, we have focused on the currently available transcatheter tricuspid valve therapies, device selection, as well as role and management of tricuspid regurgitation (TR) in the setting of other transcatheter valvular procedures., Recent Findings: In this review, we have enlisted the recently finished as well as ongoing trials in the percutaneous tricuspid valve therapies. TR is highly prevalent yet remains underrecognized and is often untreated. TR has traditionally been managed conservatively with medical therapies including diuretics for volume management, whereas surgical therapies are reserved for those undergoing left-sided valvular surgery. Although the transcatheter devices for tricuspid repair and replacement are in clinical trials, the experience to date for their effectiveness and safety has been reassuring., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

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.)

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

Background: Mitral regurgitation is the most common form of valvular heart disease worldwide, however, there is an incomplete understanding of predictors of mortality in this population. This study sought to identify risk factors of mortality in a real-world population with mitral regurgitation., Methods: All patients with moderate or severe mitral regurgitation were identified at a single center from January 1, 2016 to August 31, 2017. Multivariate regression was performed to evaluate variables independently associated with all-cause mortality., Results: A total of 490 patients with moderate (76.3%) or severe (23.7%) mitral regurgitation due to primary (20.8%) or secondary (79.2%) etiology were identified. The mean age was 66.7 years; 50% were male. At a median follow-up of 3.1 years, the incidence of all-cause mortality was 30.1%, heart failure hospitalization 23.1%, and mitral valve intervention 11.6%. Of 117 variables, multivariate analysis demonstrated 5 that were independently predictive of mortality: baseline creatinine (hazard ratio [HR] 1.2; 95% CI, 1.0-1.3; P = .02), right atrial pressure by echocardiogram (HR 1.3; 95% CI, 1.07-1.55; P = .008), hemoglobin (HR 0.65; 95% CI, 0.52-0.83; P = .001), hospitalization for heart failure (HR 1.6; 95% CI, 1.1-2.4; P = .015), and mitral valve intervention (HR 0.40; 95% CI, 0.16-0.83; P = .049)., Conclusion: In this retrospective, pragmatic analysis of patients with moderate or severe mitral regurgitation, admission for heart failure exacerbation, elevated right atrial pressure, renal dysfunction, anemia, and lack of mitral valve intervention were independently associated with increased risk of all-cause mortality. Whether these risk factors may better identify select patients who may benefit from more intensive monitoring or earlier intervention should be considered in future studies., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to evaluate outcomes of transcatheter mitral valve replacement (TMVR) with transfemoral access in patients at prohibitive or high surgical risk., Background: Prohibitive surgical risk may preclude mitral valve replacement surgery in some patients. The investigational Intrepid TMVR system has previously been evaluated using transapical access for delivery of a self-expanding bioprosthetic valve., Methods: This prospective, multicenter, nonrandomized early feasibility study evaluated the safety and performance of the Intrepid valve using transfemoral access enabling transseptal delivery in patients with moderate to severe or severe symptomatic mitral regurgitation at high surgical risk. Candidacy was determined by heart teams, with approval by a central screening committee. Echocardiographic data were evaluated by an independent core laboratory. Clinical events were adjudicated by a clinical events committee., Results: Fifteen patients were enrolled at 6 sites from February 2020 to May 2021. The median age was 80 years, and median Society of Thoracic Surgeons Predicted Risk of Mortality was 4.7%; 87% of patients were men, and 53% had undergone prior sternotomy. Fourteen implants were successful. One patient was converted to surgery during the index procedure. Patients stayed a median of 5 days postprocedure. There were 6 access site bleeds (40%) and 11 iatrogenic atrial septal defect closures (73%). At 30 days, there were no deaths, strokes, or reinterventions. All patients undergoing implantation had trace or no valvular or paravalvular mitral regurgitation, and the mean gradient was 4.7 mm Hg (IQR: 3.0-6.7 mm Hg)., Conclusions: Thirty-day results from the Intrepid transfemoral TMVR early feasibility study demonstrate excellent valve function and no mortality or stroke. Additional patients and longer follow-up are needed to confirm these findings. ([The Early Feasibility Study of the Intrepid™ TMVR Transseptal System]; NCT02322840)., 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 has received 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 has received 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 Bajwa has received personal and institutional consulting fees from Medtronic. Dr Weiss has received personal and institutional consulting fees from Medtronic and Baxter. 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 Thaden has received institutional consulting fees from Medtronic and speaker fees from Edwards Lifesciences. Ms Zhang is an employee of Medtronic. Dr Lim has received institutional grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic; and has received 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 reports that 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; serves as the national co–principal investigator of the Medtronic APOLLO FDA pivotal trial, the NeoChord ReChord FDA pivotal trial, the Medtronic CoreValve US pivotal trial, and the Abbott TRILUMINATE pivotal trial. Dr Mack serves 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 © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: We report the 30-day outcomes from the roll-in cohort of the CLASP IID trial, representing the first procedures performed by each site., Background: The currently enrolling CLASP IID/IIF pivotal trial is a multicenter, prospective, randomized trial assessing the safety and effectiveness of the PASCAL transcatheter valve repair system in patients with clinically significant MR. The trial allows for up to three roll-in patients per site., Methods: Eligibility criteria were: DMR ≥3+, prohibitive surgical risk, and deemed suitable for transcatheter repair by the local heart team. Trial oversight included a central screening committee and echocardiographic core laboratory. The primary safety endpoint was a 30-day composite MAE: cardiovascular mortality, stroke, myocardial infarction (MI), new need for renal replacement therapy, severe bleeding, and non-elective mitral valve re-intervention, adjudicated by an independent clinical events committee. Thirty-day echocardiographic, functional, and quality of life outcomes were assessed., Results: A total of 45 roll-in patients with mean age of 83 years and 69% in NYHA class III/IV were treated. Successful implantation was achieved in 100%. The 30-day composite MAE rate was 8.9% including one cardiovascular death (2.2%) due to severe bleeding from a hemorrhagic stroke, one MI, and no need for re-intervention. MR≤1+ was achieved in 73% and ≤2+ in 98% of patients. 89% of patients were in NYHA class I/II (p < .001) with improvements in 6MWD (30 m; p = .054) and KCCQ (17 points; p < .001)., Conclusions: Early results representing sites with first experience with the PASCAL repair system showed favorable 30-day outcomes in patients with DMR≥3+ at prohibitive surgical risk., (© 2021 Wiley Periodicals LLC.)

[Figure: see text].

[Figure: see text].

Background: The risk of surgical mitral valve replacement in patients with severe mitral annular calcification (MAC) is high. Several patients worldwide with severe MAC have been treated successfully with transcatheter mitral valve replacement (TMVR) using balloon-expandable aortic transcatheter valves. The TMVR in MAC Global Registry is a multicenter registry that collects data on outcomes of these procedures., Objectives: The goal of this study was to evaluate 1-year outcomes in this registry., Methods: This study was a multicenter retrospective review of clinical outcomes., Results: A total of 116 extreme surgical risk patients with severe MAC underwent TMVR; 106 had a procedure date >1 year before data-lock and were included in the analysis. Their mean age was 73 ± 12 years, and 68% were female. The mean Society of Thoracic Surgeons score was 15.3 ± 11.6%, and 90% were in New York Heart Association functional class III or IV. Thirty-day and 1-year all-cause mortality was 25% and 53.7%, respectively. Most patients who survived 30 days were alive at 1 year (49 of 77 [63.6%]), and the majority (71.8%) were in New York Heart Association functional class I or II. Echocardiography data at 1 year were available in 34 patients. Mean left ventricular ejection fraction was 58.6 ± 11.2%, mean mitral valve area was 1.9 ± 0.5 cm 2 , mean mitral gradient was 5.8 ± 2.2 mm Hg, and 75% had zero or trace mitral regurgitation., Conclusions: TMVR with balloon-expandable aortic valves in extreme surgical risk patients with severe MAC is feasible but associated with high 30-day and 1-year mortality. Most patients who survive the 30-day post-procedural period are alive at 1 year and have sustained improvement of symptoms and transcatheter valve performance. The role of TMVR in patients with MAC requires further evaluation in clinical trials., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Mitral annular calcification presents a unique challenge to the surgical and interventional management of mitral valve pathology. Herein are presented the details of an emerging use of transcatheter valve replacement not only to salvage an open operation but also to minimize the important late complications of valve migration, resulting in paravalvular leak (PVL). The valve was initially stabilized with balloon valvuloplasty to prevent further migration; a vascular plug was then used to close the PVL. Teams treating complex valvular pathology with transcatheter technologies should be aware of these pitfalls, and be prepared to manage both early and late complications that may arise after transcatheter interventions. Video 1: Paravalvular leak due to atrial migration of the stent frame. Video 2: Resolution of paravalvular leak.

Aims: Concomitant severe calcific aortic and mitral stenosis is a relatively uncommon but very challenging valvular heart disease to manage. We sought to evaluate the feasibility of a fully percutaneous approach to replace both stenotic native mitral and aortic valves using SAPIEN 3 valves., Methods and Results: An 87-year-old woman with chronic kidney disease stage 3, pul-monary hypertension, chronic obstructive pulmonary disease, a permanent pacemaker, and atrial fibrillation was referred with Class III heart failure symptoms. Her echocardiogram showed a decreased ejection fraction at 45%, severe mitral stenosis (mean gradient 13 mmHg, area 0.8 cm2) with severe MAC, and severe AS (mean gradient 35 mmHg, area 0.6 cm2). Surgical risk was felt to be very high after evaluation by our cardiothoracic sur-gery group (Society of Thoracic Surgeons risk score of 19%). She underwent simultaneous and fully percutaneous trans-femoral TAVR and transseptal TMVR using SAPIEN 3 valves. Post-implant TEE showed trace paravalvular mitral regurgitation and a mean gradient of 4 mmHg and mean aortic gradient of 8 mmHg with trace paravalvular leak. There was no LVOT obstruction. The patient was discharged seven days after the intervention., Conclusions: After careful evaluation by experienced Heart Teams, combined native stenotic mitral and aortic valves can be percutaneously replaced using transcatheter SAPIEN 3 valves via transfemoral access in carefully selected high surgical risk patients.