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Background: Tricuspid regurgitation (TR) is highly prevalent in the transcatheter aortic valve replacement (TAVR) population, but clear management guidelines are lacking., Objectives: The aims of this study were to elucidate the prevalence and consequences of severe TR in patients with aortic stenosis undergoing TAVR and to examine the change in TR post-TAVR, including predictors of improvement and its impact on longer term mortality., Methods: Using Centers for Medicare and Medicaid Services-linked TVT (Transcatheter Valve Therapy) Registry data, a propensity-matched analysis was performed among patients undergoing TAVR with baseline mild, moderate, or severe TR. Kaplan-Meier estimates were used to assess the impact of TR on 3-year mortality. Multivariable analysis identified predictors of 30-day TR improvement., Results: Of the 312,320 included patients, 84% had mild, 13% moderate, and 3% severe TR. In a propensity-matched cohort, severe baseline TR was associated with higher in-hospital mortality (2.5% vs 2.1% for moderate TR and 1.8% for mild TR; P = 0.009), higher 1-year mortality (24% vs 19.6% for moderate TR and 16.6% for mild TR; P < 0.0001), and 3-year mortality (54.2% vs 48.5% for moderate TR and 43.3% for mild TR; P < 0.0001). Among the patients with severe TR at baseline, 76.4% improved to moderate or less TR 30 days after TAVR. Baseline mitral regurgitation moderate or greater, preserved ejection fraction, higher aortic valve gradient, and better kidney function predicted TR improvement after TAVR. However, severe 30-day residual TR was associated with higher 1-year mortality (27.4% vs 18.7% for moderate TR and 16.8% for mild TR; P < 0.0001)., Conclusions: Severe baseline and 30-day residual TR after TAVR are associated with increased mortality up to 3 years. This analysis identifies a higher risk group that could be evaluated for the recently approved tricuspid interventions., Competing Interests: Funding Support and Author Disclosures Statistical analyses were supported by Edwards Lifesciences. Dr Zahr has received research and educational grants and consultation honoraria from Edwards Lifesciences, Medtronic, and Philips. Dr Elmariah is a consultant for Edwards Lifesciences and Medtronic; and has received institutional research support from Edwards Lifesciences and Medtronic. Dr Vemulapalli has received grants or contracts from the American College of Cardiology, the STS, Cytokinetics, Abbott Vascular, the National Institutes of Health (R01 and SBIR), and Boston Scientific; and has performed consultation work for and holds advisory board status with Janssen, the American College of Physicians, HeartFlow, and Edwards Lifesciences. Dr Kodali is a consultant for Admedus, Meril Lifesciences, JenaValve, and Abbott Vascular; and holds equity in Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve, Supira, and Admedus. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; holds institutional consultation contracts with no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; holds stock options with Navigate; and is the chief scientific officer for the echocardiography core laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr Davidson has received research grant support from and performed unpaid consultation for Edwards Lifesciences. Dr O’Neill is a consultant for Abiomed, Medtronic, and Boston Scientific. Dr Bethea has received consultation fees from Abbott Vascular. Dr Thourani has been an advisor for Abbott Vascular, Artivion, AtriCure, Boston Scientific, Edwards Lifesciences, Medtronic, and Shockwave Medical. Dr Chakravarty is a consultant for Edwards Lifesciences, Boston Scientific, Medtronic, and Abbott. Dr Gupta is a consultant for Boston Scientific and Shockwave Medical; and holds equity in Heartbeat Health and iCardio.ai. Dr Makkar has received research grants from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific; has received personal proctoring funds from Edwards Lifesciences; has received travel support from Edwards Lifesciences, Abbott, and Boston Scientific; and serves as national principal investigator for the Portico (Abbott) and Acurate (Boston Scientific) U.S. investigation device exemption trials. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Outcomes from transcatheter aortic valve replacement (TAVR) in low-surgical risk patients with bicuspid aortic stenosis beyond 2 years are limited., Objectives: This study aimed to evaluate 3-year clinical and echocardiographic outcomes from the Evolut Low Risk Bicuspid Study., Methods: The Evolut Low Risk Bicuspid Study is a prospective, multicenter, single-arm study conducted in 25 U.S., Centers: Patients with severe aortic stenosis at low surgical risk with bicuspid aortic valve anatomy (all subtypes) underwent TAVR with a self-expanding, supra-annular Evolut R or PRO (Medtronic) bioprosthesis. An independent clinical events committee adjudicated all deaths and endpoint-related adverse events, and a central echocardiographic core laboratory assessed hemodynamic endpoints., Results: An attempted implant was performed in 150 patients from December 2018 to October 2019. The mean age was 70.3 ± 5.5 years, 48% (72/150) of the patients were women, and the mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 1.3% (Q1-Q3: 0.9%-1.7%). Sievers type 1 was the dominant bicuspid morphology (90.7%, 136/150). The Kaplan-Meier rates of all-cause mortality or disabling stroke were 1.3% (95% CI: 0.3%-5.3%) at 1 year, 3.4% (95% CI: 1.4%-8.1%) at 2 years, and 4.1% (95% CI: 1.6%-10.7%) at 3 years. The incidence of new permanent pacemaker implantation was 19.4% (95% CI: 12.4%-29.6%) at 3 years. There were no instances of moderate or severe paravalvular aortic regurgitation at 2 and 3 years after TAVR., Conclusions: The 3-year results from the Evolut Low Risk Bicuspid Study demonstrate low rates of all-cause mortality or disabling stroke and favorable hemodynamic performance., Competing Interests: Funding Support and Author Disclosures Medtronic funded the Low Risk study. Dr Zahr has received grant support/research support from Edwards Lifesciences and Medtronic; and has received consultant fees/honoraria from Edwards Lifesciences and Medtronic. Dr Ramlawi has received grants, personal fees, and nonfinancial support from Medtronic, LivaNova, and AtriCure. Dr Reardon has received grants from Medtronic (paid to institution) during the conduct of the study; and has received consulting fees from Abbott, Boston Scientific, and Gore Medical (paid to institution) outside of the submitted work. Dr Deeb has received grants from Medtronic (paid to institution) during the conduct of the trial; and has received personal fees from Medtronic outside the submitted work. Dr Yakubov has received grants from Boston Scientific and Medtronic (paid to institution); and has received personal fees from Medtronic during the conduct of the study. Dr Song has received grant support/research contracts from Medtronic; and has received consultant fees from Medtronic. Dr Kleiman has received clinical trial reimbursement to his institution (Houston Methodist DeBakey Heart and Vascular Center) during the conduct of the study. Dr Chetcuti serves on the Advisory Board for Medtronic; and serves as a consultant for Medtronic, Edwards Lifesciences, and Abbott. Dr Gada has received personal fees from Medtronic, Abbott, Becton Dickinson, and Boston Scientific outside the submitted work. Dr Mumtaz has received grants and personal fees from Medtronic, Edwards Lifesciences, AtriCure, Japanese Organization for Medical Device Development, and Z Medical outside the submitted work. Dr Rovin serves as a consultant, proctor, and speaker for Abbott and Medtronic. Dr Kauten serves as a consultant for Boston Scientific and Medtronic. Dr Huang is an employee and shareholder of Medtronic. Dr Forrest has received grant support/research contracts from Edwards Lifesciences and Medtronic; and has received consultant fees/honoraria/Speakers Bureau fees from Edwards Lifesciences and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Transcatheter aortic valve replacement (TAVR) has emerged as an alternative treatment option for patients with severe aortic stenosis regardless of surgical risk, particularly in those with a high and prohibitive risk. Since the advent of TAVR, transfemoral access has been the standard of care. However, given comorbidities and anatomical limitations, a proportion of patients are not good candidates for a transfemoral approach. Alternative access, including transapical, transaortic, transaxillary, transsubclavian, transcarotid, and transcaval, can be considered. Each alternative access has advantages and disadvantages, so the vascular route should be tailored to the patient's characteristics. However, there is no standardized algorithm when choosing the optimal alternative vascular access. In this review, we analyzed the evolution and current evidence for the most common alternative access for TAVR and proposed an algorithm for choosing the optimal vascular access in this patient population.

Background: Surgery remains the only recommended intervention for patients with native aortic regurgitation. A transcatheter therapy to treat patients at high risk for mortality and complications with surgical aortic valve replacement represents an unmet need. Commercial transcatheter heart valves in pure aortic regurgitation are hampered by unacceptable rates of embolisation and paravalvular regurgitation. The Trilogy transcatheter heart valve (JenaValve Technology, Irvine, CA, USA) provides a treatment option for these patients. We report outcomes with transfemoral transcatheter aortic valve implantation (TAVI) in patients with pure aortic regurgitation using this dedicated transcatheter heart valve., Methods: The ALIGN-AR trial is a prospective, multicentre, single-arm study. We recruited symptomatic patients (aged ≥18 years) with moderate-to-severe or severe aortic regurgitation at high risk for mortality and complications after surgical aortic valve replacement at 20 US sites for treatment with the Trilogy transcatheter heart valve. The 30-day composite primary safety endpoint was compared for non-inferiority with a prespecified performance goal of 40·5%. The primary efficacy endpoint was 1-year all-cause mortality compared for non-inferiority with a performance goal of 25%. This trial is registered with ClinicalTrials.gov, NCT04415047, and is ongoing., Findings: Between June 8, 2018, and Aug 29, 2022, we screened 346 patients. We excluded 166 (48%) patients and enrolled 180 (52%) patients with symptomatic aortic regurgitation deemed high risk by the heart team and independent screening committee assessments. The mean age of the study population was 75·5 years (SD 10·8), and 85 (47%) were female, 95 (53%) were male, and 131 (73%) were White. Technical success was achieved in 171 (95%) patients. At 30 days, four (2%) deaths, two (1%) disabling strokes, and two (1%) non-disabling strokes occurred. Using standard Valve Academic Research Consortium-2 definitions, the primary safety endpoint was achieved, with events occurring in 48 (27% [97·5% CI 19·2-34·0]) patients (p non-inferiority <0·0001), with new pacemaker implantation in 36 (24%) patients. The primary efficacy endpoint was achieved, with mortality in 14 (7·8% [3·3-12·3]) patients at 1 year (p non-inferiority <0·0001)., Interpretation: This study shows the safety and effectiveness of treating native aortic regurgitation using a dedicated transcatheter heart valve to treat patients with symptomatic moderate-to-severe or severe aortic regurgitation who are at high risk for mortality or complications after surgical aortic valve replacement. The observed short-term clinical and haemodynamic outcomes are promising as are signs of left ventricular remodelling, but long-term follow-up is necessary., Funding: JenaValve Technology., Competing Interests: Declaration of interests TPV reports institutional funding to Columbia University Irving Medical Center from JenaValve Technology, Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic; and he personally received consulting fees from 4C Medical and Philips. OKK reports that he is part of a core laboratory contracting with JenaValve Technology but he has not received any direct compensation; he further reports consulting fees from Edwards Lifesciences, VDyne, Siemens, Philips, Laralab, and Restore Medical. NH reports that she is part of a core laboratory contracting with JenaValve Technology but she has not received any direct compensation. JMM reports consulting fees and honoraria from Edwards Lifesciences, Medtronic, Abbott, Shockwave, and Equity in Excision Medical, and Conkay Medical. IG reports consulting fees from Edwards Lifesciences, Medtronic, Boston Scientific, Abbott SJM, and Atricure. SKK reports consultant fees (honoraria) from Admedus, Meril Lifesciences, JenaValve Technology, and Abbott Vascular; scientific advisory board participation (equity) with Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve, Supira, and Admedus; and institutional funding to Columbia University and the Cardiovascular Research Foundation from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve Technology. NA reports medical advisory board fees and consultant and proctor fees from Nininger Medical, Edwards Lifesciences, V-wave, JenaValve Technology, Abbott, Vdyne, and Boston Scientific, and participation in industry-sponsored trials and research funding from Edwards Lifesciences, JenaValve Technology, Boston Scientific, V-wave, AccuCinch, Highlife, Tendyne, and preCardia. DSP is the Chief Medical officer of JenaValve Technology and a consultant for Abiomed, Abbott Vascular, Magenta, NuPulseCV, and Terumo. MBL reports institutional clinical research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and JenaValve Technology. HG reports consulting fees from Medtronic and Boston Scientific. All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Aims: Patients with heart failure and mildly reduced or preserved ejection fraction have limited therapeutic options. The ALT-FLOW Early Feasibility Study evaluated safety, haemodynamics and outcomes for the APTURE transcatheter shunt system, a novel left atrium to coronary sinus shunt in these patients., Methods and Results: Safety and shunt implantation success was evaluated for all 116 enrolled patients. An analysis population of implanted patients with a left ventricular ejection fraction (LVEF) >40% (n = 95) was chosen to assess efficacy via paired comparison between baseline and follow-up haemodynamic (3 and 6 months), and echocardiographic, clinical and functional outcomes (6 months and 1 year). Health status and quality of life outcomes were assessed using the Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS). The primary safety endpoint, major adverse cardiac, cerebral, and renal events, and reintervention through 30 days, occurred in 3/116 patients (2.6%). All implanted shunts were patent at 1 year. In patients with LVEF >40%, the mean (95% confidence interval) reduction in exercise pulmonary capillary wedge pressure (PCWP) at 20 W was -5.7 (-8.6, -2.9) mmHg at 6 months (p < 0.001). At baseline, 8% had New York Heart Association class I-II status and improved to 68% at 1 year (p < 0.001). KCCQ-OSS at baseline was 39 (35, 43) and improved at 6 months and 1 year by 25 (20-30) and 27 (22-32) points, respectively (both p < 0.0001). No adverse changes in haemodynamic and echocardiographic indices of right heart function were observed at 1 year. Overall, the reduction in PCWP at 20 W and improvement in KCCQ-OSS in multiple subgroups were consistent with those observed for the entire population., Conclusions: In patients with heart failure and LVEF >40%, the APTURE shunt demonstrated an acceptable safety profile with significant sustained improvements in haemodynamic and patient-centred outcomes, underscoring the need for further evaluation of the APTURE shunt in a randomized trial., (© 2024 European Society of Cardiology.)

Mitral valve dysfunction is prevalent amongst older patients. Of those not suitable for surgical therapy, mitral transcatheter edge-to-edge repair (TEER) can treat as large proportion of patients, many are not suitable TEER candidates. As such, orthotopic transcatheter mitral valve replacement (TMVR) is an important innovation but it faces significant challenges. Orthotopic TMVR requires a prosthesis with stable anchoring, adequate sealing, minimal footprint in the left ventricle and long term durability. Multidisciplinary expertise in advanced imaging, surgery, heart failure are needed for success., Competing Interests: Disclosure M.H. Eng is a clinical proctor for Edwards Lifesciences and Medtronic. He is on the speaker’s panel for LivaNova. F. Zahr receives research and educational grants and is a consultant for Edwards Lifesciences, United States and Medtronic., (Copyright © 2024 Elsevier Inc. All rights reserved.)

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

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

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

In 2022, the Food and Drug Administration approved a second mitral transcatheter edge-to-edge repair device for the treatment of primary mitral regurgitation (PASCAL Precision Transcatheter Valve Repair System, Edwards Lifesciences, Irvine, CA). The PASCAL Precision system consists of a guide sheath, implant system, and accessories. The implant system consists of a steerable catheter, an implant catheter, and the implant (PASCAL or PASCAL Ace). The guide sheath and steerable catheter move and flex independently from each other and are not keyed, allowing for freedom of rotation in three dimensions. This manuscript provides an overview of the PASCAL Precision system and describes the basic and advanced steering maneuvers to facilitate effective and safe mitral transcatheter edge-to-edge repair., Competing Interests: S. Garcia, S. Elmariah, R. Cubeddu, F. Zahr, S. K. Kodali, R. Sharma, and D. S. Lim: institutional grant support from Edwards Lifesciences. Other authors have nothing to disclose., (© 2023 The Author(s).)

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

Competing Interests: Brian Whisenant reports a relationship with Edwards Lifesciences Corporation that includes: consulting or advisory and speaking and lecture fees. Brian Whisenant reports a relationship with Abbott Cardiovascular Structural Heart Division that includes: consulting or advisory.

Background: Heart failure (HF) is associated with both mortality and a significant decline in health status. Interatrial shunting is increasingly being investigated as a novel therapeutic option., Objectives: The ALT FLOW Early Feasibility Study was designed to evaluate the safety of the Edwards left atrial to coronary sinus APTURE Transcatheter Shunt System in patients with symptomatic HF., Methods: A total of 18 centers enrolled patients with symptomatic HF with a pulmonary capillary wedge pressure >15 mm Hg at rest or 25 mm Hg during exercise., Results: Between May 2018 and September 2022, 87 patients underwent attempted APTURE shunt implantation. Mean age was 71 years, and 53% were male. At baseline, mean left ventricular ejection fraction was 59% with 90% of the patients being in NYHA functional class III. Device success was achieved in 78 patients (90%), with no device occlusions or associated adverse events identified after implantation. The primary safety outcome occurred in only 2 patients (2.3%) at 30 days. At 6 months, health status improved: 67% of participants achieved NYHA functional class I to II status, with a 23-point improvement (P < 0.0001; 95% CI: 17-29 points) in the Kansas City Cardiomyopathy Questionnaire overall summary score. Also at 6 months, 20-W exercise pulmonary capillary wedge pressure was 7 mm Hg lower (P < 0.0001; 95% CI: -11 to -4 mm Hg) without change in right atrial pressure or other right heart function indices., Conclusions: In this single-arm experience, the APTURE Transcatheter Shunt System in patients with symptomatic HF was observed to be safe and resulted in reduction in pulmonary capillary wedge pressure and clinically meaningful improvements in HF symptoms and quality of life indices., Competing Interests: Funding Support and Author Disclosures This study was funded by Edwards Lifesciences, who also directed the design and conduct of the study, the collection, analysis, and interpretation of the data with input from their lead investigators. Dr Hibbert has received institutional research support from Abbott, NXT, Edwards Lifesciences, Boston Scientific, and Occlutech. Dr Zahr is a consultant to Edwards Lifesciences and Medtronic; and has received research and educational grants from Edwards Lifesciences, Medtronic, and Siemens. Dr Simard is a consultant to Boston Scientific; and has received research support from Edwards Lifesciences. Dr Nazer is a consultant to Boston Scientific and Biosense Webster; and has received investigator-initiated research funding from Siemens and Galaxy Medical. Dr Sorajja has served on advisory boards for 4C Medical, Abbott Vascular Structural, Boston Scientific SHV Strategic Advisory Board, Medtronic Structural Advisory Board, and VDyne; and is a consultant to 4C Medical, Anteris, Abbott Structural, Boston Scientific, Edwards Lifesciences, Evolution Medical, Foldax, GLG, Medtronic, Phillips, Siemens, Shifamed, WL Gore, VDyne, and xDot. Dr Pineda is a consultant to Cardiovascular Systems, Inc. Dr Schwartz has been a consultant for Abbott Vascular Structural, Boston Scientific, Edwards Lifesciences, Medtronic, Philips, WL Gore, Cordis; serves on advisory boards for Medtronic, Boston Scientific, Edwards Lifesciences, and Cordis; and has received research funding from Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, Philips, WL Gore, and Cordis. Dr Wiley is a consultant to Edwards Lifesciences. Dr Sauer has received speaker or consulting honoraria from Edwards Lifesciences, Abbott, Boston Scientific, Biotronik, Medtronic, Bayer, General Prognostics, Impulse Dynamics, and Story Health. Dr Jorde is a consultant to Abbott, Edwards Lifesciences, and AncoraHeart. Dr Latib is a consultant for Edwards Lifesciences, Abbott Vascular, Medtronic, Boston Scientific, and Philips. Dr Kahwash is a consultant and serves on advisory boards for Medtronic, Cardionomic, and Impulsedynamics. Dr Gafoor is a consultant to Edwards Lifesciences, Abbott Lifesciences, and Boston Scientific. Dr Chaudhry has received speaker honoraria from Medtronic; and consultation fees from Edwards Lifesciences. Dr. Hermiller is a consultant to Edwards Lifesciences. Drs Aldaia and Koulogiannis are members of a cardiovascular core lab, for which they receive no direct compensation, that has agreements with Edwards Lifesciences, Abbott, Medtronic, and NXT Biomedical. Dr Koulogiannis is also a consultant to Edwards Lifesciences and Abbott; and serves on an advisory board for Edwards Lifesciences. Dr Gray is a consultant to Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

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

Background: 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: Cardiac computed tomography angiography was used to identify anatomical characteristics of the aortic root in patients with severe aortic regurgitation (AR) as compared to those with aortic stenosis (AS) to judge feasibility of transcatheter aortic valve replacement (TAVR) with the JenaValve Trilogy system., Methods: Cardiac computed tomography angiography was performed prior to planned TAVR for 107 patients with severe AR and 92 patients with severe AS. Measurements related to aortic root and coronary artery anatomy were obtained and compared between groups. Perimeter >90 mm and aortic annulus angle ​>70 degrees were defined as the theoretical exclusion criteria for TAVR. A combination of sinus of Valsalva diameter <30 mm and coronary height <12 mm was defined as high risk for coronary occlusion., Results: The mean age of patients in the AR group was 74.9 ± 11.2 years, 46% were women, and the mean Society of Thoracic Surgeons risk score for mortality was 3.6 ± 2.1. Comparatively, the mean age of patients in the AS group was 82.3 ± 5.53 years, 65% were women, and the mean Society of Thoracic Surgeonsrisk score was 5.5 ± 3.3. Annulus area, perimeter, diameter, and angle were larger in patients with severe AR. Sinus of Valsalva diameters and heights were larger in patients with severe AR. More AR patients were excluded based on perimeter (14 vs. 2%) and annulus angle (6 vs. 1%). More AS patients exhibited high-risk anatomy for left main coronary occlusion (21 vs. 7%) and right coronary occlusion (14 vs. 3%). The maximum dimension of the ascending aorta was larger in patients with severe AR (39 vs. 35 mm). The percentage of referred AR patients with significant aortopathy requiring surgical intervention was very low (only 1 AR patient with ascending aorta diameter >5.5 cm)., Conclusions: A significantly larger proportion of patients with severe AR are excluded from TAVR as compared to AS due to large aortic annulus size and steep annulus angulation. By far the most prevalent excluding factor is aortic annulus size, with fewer patients excluded due to angulation. AR patients have lower-risk anatomy for coronary occlusion. Larger transcatheter valve sizes and further delivery system modifications are required to treat a larger proportion of AR patients., Competing Interests: Dr. George is a consultant for Durvena, Cardiomech, Vdyne, Valcare Medical, Atricure, Zimmer Biomet, MITrx, Mitremedical and has institutional grants from Edwards, Medtronic, Abbott. Dr. Khalique is a consultant for Edwards, Abbott Structural, Triflo, Cardiac Implants, Restore Medical, and Croivalve and is a member of a corelab (he receives no direct industry compensation) with contracts with Ancora, Jenavalve, Atricure, and Abbott Structural and holds equity in Triflo and Cardiac Implants. Dr. Vahl reports institutional funding to Columbia University Medical Center from Abbott, Boston Scientific, Edwards, Jenavalve, and Medtronic, and has received consulting fees from 4D Medical Technologies and Baylis Medical. Dr. Chen is a member of a corelab (she receives no direct industry compensation) with contracts with Ancora and Jenavalve and is a consultant for Intrinsic Imaging, LLC. Dr. McCabe is a consultant for Edwards, Boston Scientific, Medtronic and CSI and holds equity in ConKay Medical and Excision Medical. Vinod Thourani is a medical advisor for Edwards, is a national PI for the Jenavalve Pivotal trial, and is co-founder of Apica cardiovascular. Dr. Treede reports consulting fees from TRICARES. Dr. Baldus reports honoraria from Edwards and Abbott, and a research grant from Abbott. Dr. Zahr reports institutional research support from Edwards and Medtronic. Dr. Russo reports honoraria from Edwards and Abbott. Dr. Leon has received institutional grants from Abbott, Boston Scientific, Edwards, Jenavalve, and Medtronic and holds equity in Valve Medical, Picardia, and Venus MedTech. Dr. Makkar received grant support from Edwards and is a consultant for Abbott, Cordis, and Medtronic., (© 2023 The Authors.)

Background: Studies comparing plug-based (i.e., MANTA) with suture-based (i.e., ProStar XL and ProGlide) vascular closure devices (VCDs) for large-bore access closure after transcatheter aortic valve replacement (TAVR) have yielded mixed results., Aims: To examine the comparative safety and efficacy of both types of VCDs among TAVR recipients., Methods: An electronic database search was performed through March 2022 for studies comparing access-site related vascular complications with plug-based versus suture-based VCDs for large-bore access site closure after transfemoral (TF) TAVR., Results: Ten studies (2 randomized controlled trials [RCTs] and 8 observational studies) with 3113 patients (MANTA = 1358, ProGlide/ProStar XL = 1755) were included. There was no difference between plug-based and suture-based VCD in the incidence of access-site major vascular complications (3.1% vs. 3.3%, odds ratio [OR]: 0.89; 95% confidence interval [CI]: 0.52-1.53). The incidence of VCD failure was lower in plug-based VCD (5.2% vs. 7.1%, OR: 0.64; 95% CI: 0.44-0.91). There was a trend toward a higher incidence of unplanned vascular intervention in plug-based VCD (8.2% vs. 5.9%, OR: 1.35; 95% CI: 0.97-1.89). Length of stay was shorter with MANTA. Subgroup analyses suggested significant interaction based on study designs such that there was higher incidence of access-site vascular complications and bleeding events with plug-based versus suture-based VCD among RCTs., Conclusion: In patients undergoing TF-TAVR, large-bore access site closure with plug-based VCD was associated with a similar safety profile as suture-based VCD. However, subgroup analysis showed that plug-based VCD was associated with higher incidence of vascular and bleeding complications in RCTs., (© 2023 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

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.)

Objective: To compare 1-year outcomes in patients at low surgical risk with bicuspid aortic valve stenosis (AS) following transcatheter aortic valve replacement (TAVR) and low-risk patients with tricuspid AS following surgical aortic valve replacement (SAVR)., Background: The pivotal randomized, prospective, multicenter TAVR trials compared TAVR vs SAVR in patients with tricuspid AS. No such trials exist for bicuspid AS., Methods: The Low Risk Bicuspid Study is a prospective, single-arm, TAVR trial that enrolled 150 patients from 25 sites in the United States. A screening committee confirmed bicuspid anatomy and valve classification based on computed tomography using the Sievers classification. Annular measurements guided valve sizing. These patients were propensity-matched to the SAVR patients in the randomized Evolut Low Risk Trial using 1:1 5-to-1-digit Greedy method, resulting in 144 matched pairs. For both trials, an independent clinical events committee adjudicated all serious adverse events, and the same independent core laboratory assessed all echocardiograms., Results: The 1-year composite of death, disabling stroke, or aortic valve-related rehospitalization for bicuspid TAVR vs tricuspid SAVR was 6 (4.2%) vs 6 (4.2%) ( P = .99). The effective orifice area (2.2 ± 0.7 cm 2 vs 2.0 ± 0.6 cm 2 ) was larger and the valve gradient was lower (8.7 ± 3.9 mm Hg vs 11.2 ± 4.7 mm Hg) in the TAVR group at 1 year (both P < .001). Moderate/severe aortic regurgitation was present in 1 TAVR and 2 SAVR patients (0.8% vs 1.6%; P > .99)., Conclusions: In this select group of low-risk bicuspid patients, in the short-term follow-up, TAVR appears to have similar outcomes to those seen in comparable low-risk tricuspid patients undergoing SAVR., (© 2022 The Authors.)

Background: Anemia is associated with increased mortality in patients undergoing transcatheter aortic valve replacement (TAVR); however, data on the effect of the severity of and recovery from anemia on clinical outcomes are limited. This study examined the impact of the severity of and recovery from anemia after TAVR., Methods: Patients with symptomatic, severe aortic stenosis across all surgical risk groups from the Placement of Aortic Transcatheter Valves (PARTNER) I, II, and III trials and registries who underwent TAVR were analyzed. Baseline anemia was defined as mild (hemoglobin [Hb] level ≥11.0 g/dL and <13.0 g/dL for men and ≥11.0 g/dL and <12.0 g/dL for women) and moderate-to-severe anemia (Hb level <11.0 g/dL). Recovery from anemia was defined as an increase of ≥1 g/dL in the Hb level. Patients with missing Hb information and major bleeding within 30 days were excluded. The association of the severity of and recovery from anemia with clinical outcomes was analyzed using multivariable Cox proportional hazards regression models. The primary outcome was 1-year all-cause mortality., Results: The Kaplan-Meier estimate for 1-year all-cause mortality was 5.4%, 8.2%, and 14.5% in patients with no, mild, and moderate-to-severe anemia, respectively ( P < .001). Recovery from anemia at 30 days occurred in 8.4% (229/2730) of all patients. Compared with those without baseline or 30-day anemia, patients with recovery from anemia had similar 1-year mortality (hazard ratio, 1.02; CI, 0.50-2.08; P = .96), whereas those without recovery from anemia had higher 1-year mortality (hazard ratio, 1.82; CI, 1.17-2.85; P = .009)., Conclusions: In patients undergoing TAVR, moderate-to-severe anemia is independently associated with increased 1-year mortality, and recovery from anemia after TAVR is associated with favorable outcomes. Further efforts are needed to determine whether preprocedural correction of anemia improves post-TAVR outcomes., (© 2022 The Authors.)

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.)

Background: There is a paucity of data on cardiogenic shock (CS) incidence and outcomes among patients with spontaneous coronary artery dissection (SCAD)., Methods: Women admitted to the hospital for acute myocardial infarction (AMI) with and without SCAD were identified from the United States National Readmission Database from October 1, 2015 to December 31, 2018. We calculated the incidence of CS among women with AMI with and without SCAD and odds for developing CS after adjusting for baseline characteristics. In addition, we report the utilization of percutaneous coronary intervention, mechanical circulatory support, severe disability surrogates, and 30-day readmission rates., Results: A total of 664,292 patients admitted for AMI were eligible for analysis, including 6643 patients with SCAD and 657,649 without SCAD. Patients with SCAD were younger (57 years [interquartile range, IQR 48-68] vs. 71 years [IQR 60-81], p < 0.01) and had fewer comorbidities yet had a higher incidence of CS as compared to patients without SCAD (9% vs. 5%, p < 0.01) and remained at elevated risk after adjusting for baseline comorbidities (adjusted odds ratio 1.5 [95% confidence interval, CI 1.2-1.7]). Among patients who developed CS, those with SCAD had lower in-hospital mortality than non-SCAD (31% vs. 39%, p < 0.01), and were more likely to receive mechanical circulatory support., Conclusions: In a nationally representative sample of women admitted for AMI, we found that patients with SCAD had a higher risk of developing CS and required more frequent use of mechanical circulatory support but were more likely to survive to discharge than women suffering AMI from causes other than SCAD., (© 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.)