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

Background: Tricuspid regurgitation (TR) is a common valve disease that has a significant impact on patients' quality of life., Objectives: This study sought to report the final 3-year outcomes of tricuspid transcatheter edge-to-edge repair (T-TEER) with the TriClip (Abbott) implant from the TRILUMINATE (TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR) study for the treatment of severe symptomatic TR., Methods: The TRILUMINATE study (N = 98 subjects) is an international, prospective, single-arm, multicenter study to investigate the safety and performance of T-TEER with the TriClip implant in patients with symptomatic moderate or greater TR. Echocardiographic assessments were performed at a core laboratory., Results: At 3 years, TR was reduced to moderate or less in 79% of subjects, and a reduction of at least 1 grade was achieved in 92% of subjects. TR reduction achieved at 1 year was sustained through 3 years. Subjects also experienced an improvement in heart failure symptoms assessed by NYHA functional class and quality of life assessed by the Kansas City Cardiomyopathy Questionnaire at 3 years compared to baseline. The site-reported heart failure hospitalization rate decreased from 0.56 events/patient-year 1 year before device implantation to 0.14 events/patient-year 3 years after device implantation, representing a reduction of 75% (P < 0.0001)., Conclusions: In the longest follow-up to date of any T-TEER therapy, the TRILUMINATE study demonstrated that the TriClip procedure is both safe and effective, with sustained benefits at 3 years in subjects with symptomatic moderate or greater TR. (TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR [TRILUMINATE]; NCT03227757)., Competing Interests: Funding Support and Author Disclosures This study was supported by Abbott Structural Heart. Dr Nickenig has received research funding and honoraria from Abbott, Edwards Lifesciences, and Medtronic; and has participated in clinical trials with Abbott, Edwards Lifesciences, and Medtronic. Dr Lurz has served as a consultant for Abbott Structural Heart, Edwards Lifesciences, Medtronic, ReCor, and Occlutech. Dr Sorajja has served as a consultant for 4C Medical, Abbott Structural, Adona, Boston Scientific, Edwards Lifesciences, Foldax, GE Medical, GLG, Medtronic, Phillips, Siemens, WL Gore, vDyne, and xDot; and has received personal fees from Abbott Vascular (outside the submitted work). Dr von Bardeleben has received institutional research grants and speaker honorarium from Abbott Vascular and Edwards Lifesciences; and has received nonfinancial trial support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Lifetec, and Medtronic. Dr Sitges has served as a consultant for Abbott, Edwards Lifesciences, Metronic, and General Electric; has received speaker honoraria from Abbott, Edwards Lifesciences, Medtronic, and General Electric; and has received speaker honoraria and travel and grant support from Abbott. Dr Hausleiter has received speaker honoraria and research support from Abbott Vascular and Edwards Lifesciences. Dr Trochu has received speaker honoraria, travel support, and grant support from Abbott and Novartis; has received honoraria for lectures or advisory boards from Amgen, Bayer, and Resmed; and has been an unpaid member of the Corvia Medical Scientific Advisory Group. Dr Näbauer has received speaker honoraria from Abbott. Dr Heitkemper is an employee of Abbott. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; and has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Tricuspid valve disease is an often underrecognized clinical problem that is associated with significant morbidity and mortality. Unfortunately, patients will often present late in their disease course with severe right-sided heart failure, pulmonary hypertension, and life-limiting symptoms that have few durable treatment options. Traditionally, the only treatment for tricuspid valve disease has been medical therapy or surgery; however, there have been increasing interest and success with the use of transcatheter tricuspid valve therapies over the past several years to treat patients with previously limited therapeutic options. The tricuspid valve is complex anatomically, lying adjacent to important anatomic structures such as the right coronary artery and the atrioventricular node, and is the passageway for permanent pacemaker leads into the right ventricle. In addition, the mechanism of tricuspid pathology varies widely between patients, which can be due to primary, secondary, or a combination of causes, meaning that it is not possible for 1 type of device to be suitable for treatment of all cases of tricuspid valve disease. To best visualize the pathology, several modalities of advanced cardiac imaging are often required, including transthoracic echocardiography, transesophageal echocardiography, cardiac computed tomography, and cardiac magnetic resonance imaging, to best visualize the pathology. This detailed imaging provides important information for choosing the ideal transcatheter treatment options for patients with tricuspid valve disease, taking into account the need for the lifetime management of the patient. This review highlights the important background, anatomic considerations, therapeutic options, and future directions with regard to treatment of tricuspid valve disease.

Background: Transcatheter mitral edge-to-edge repair (TEER) is an increasingly common procedure performed on patients with severe mitral regurgitation. This study assessed the impact of race/ethnicity and socioeconomic status on in-hospital complications after TEER., Methods: Cohort-based observational study using the National Inpatient Sample between October 2013 and December 2018. The population was stratified into 4 groups based on race/ethnicity and quartiles of neighborhood income levels. The primary outcome was in-hospital complications, defined as the composite of death, bleeding, cardiac and vascular complications, acute kidney injury, and ischemic stroke., Results: 3795 hospitalizations for TEER were identified. Patients of Black and Hispanic race/ethnicity comprised 7.4% and 6.4%, respectively. We estimated that White patients received TEER with a frequency of 38.0/100,000, compared to 29.7/100,000 for Blacks and 30.5/100,000 for Hispanics. In-hospital complications occurred in 20.2% of patients and no differences were found between racial/ethnic groups (P = 0.06). After multilevel modelling, Black and Hispanic patients had similar rate of overall in-hospital complications (OR: 0.84, CI:0.67-1.05 and OR: 0.84, CI:0.66-1.07, respectively) as compared to White patients, however, higher rates of death were observed in Black patients. Individuals living in income quartile-1 had worse in-hospital outcomes as compared to quartile-4 (OR: 1.19, CI:0.99-1.42)., Conclusion: In this study assessing racial/ethnic disparities in TEER outcomes, aged-adjusted race/ethnicity minorities were less underrepresented as compared to other structural heart interventions. Black patients experienced a higher rate of in-hospital death, but similar overall rate of post-procedural adverse events as compared to White patients. Lower income levels appear to negatively impact on in-hospital outcomes., Brief Summary: This study appraises race/ethnic and socioeconomical disparities in access and outcomes following transcatheter mitral edge-to-edge repair. Racial minority groups were less underrepresented as compared to other structural heart interventions. While Black patients experienced a higher rate of in-hospital death, they experienced similar overall rate of post-procedural complications compared to White patients. Lower income levels also appeared to negatively impact on outcomes., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Objectives: The aim of this study was to examine real-world experience with repeat transcatheter aortic valve replacement (TAVR) in a population-based national database., Background: Repeat TAVR is a growing option in patients requiring reintervention for TAVR. However, large-scale studies with longitudinal follow-up are limited., Methods: All Medicare beneficiaries who underwent TAVR from 2012 to 2017 were included. Outcomes included 30-day and longitudinal mortality and major adverse cardiovascular events, defined as death, stroke, pacemaker insertion, major bleeding, acute kidney injury, or cardiac arrest. Outcomes of repeat TAVR were compared with surgical explantation after TAVR (TAVR explantation) in a matched analysis., Results: Of 133,250 patients who underwent TAVR, 617 (0.46%) underwent subsequent repeat TAVR at a median interval of 154 days (interquartile range: 58-537 days). Mortality at 30 days and 1 year was 6.0% and 22.0%, respectively. Rates of 30-day stroke and pacemaker insertion were 1.8% and 4.2%. Mortality at 30 days was lower in those who underwent their first TAVR during the later era (2015-2017) compared with earlier years (2012-2014) (4.6% vs 8.7%; P = 0.049). Repeat TAVR was associated with lower 30-day mortality compared with a matched group undergoing TAVR explantation (6.2% vs 12.3%; P = 0.05), although 1-year mortality was similar (21.0% vs 20.8%; P = 1.000). The incidence of 30-day major adverse cardiovascular events was higher with TAVR explantation compared with repeat TAVR (risk ratio: 2.92; 95% CI: 1.88-4.99; P ≤ 0.001)., Conclusions: Repeat TAVR was performed with acceptable 30-day mortality in this high-risk population. Short-term outcomes were superior to surgical explantation, but 1-year outcomes were similar. Repeat TAVR will likely be an important option for aortic valve reintervention after TAVR., Competing Interests: Funding Support and Author Disclosures This work was supported by Levinger gift funds from Brigham and Women’s Hospital, Harvard Medical School. Dr Kaneko is a speaker for Edwards Lifesciences, Medtronic, Abbott, and Baylis Medical; and is a consultant for 4C Medical. Dr Tang is a physician proctor for Medtronic; and is a consultant for Medtronic, W.L. Gore & Associates, and Abbott Structural Heart. Dr Bapat has served as a consultant for Medtronic, Edwards Lifesciences, 4C Medical, and Boston Scientific. Dr O’Gara has been a consultant to Medtronic and Edwards Lifesciences. Dr Bhatt is an advisory board member for Cardax, Cereno Scientific, Elsevier Practice Update Cardiology, Medscape Cardiology, PhaseBio, PLx Pharma, and Regado Biosciences; is on the boards of directors of the Boston VA Research Institute, the Society of Cardiovascular Patient Care, and TobeSoft; is chair of the American Heart Association Quality Oversight Committee; is a member of data monitoring committees for the Baim Institute for Clinical Research (formerly the Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), the Cleveland Clinic (including for the ExCEED trial, funded by Edwards Lifesciences), the Duke Clinical Research Institute, the Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi-Sankyo), and the Population Health Research Institute; has received honoraria from the American College of Cardiology (senior associate editor, Clinical Trials and News, ACC.org; vice chair, ACC Accreditation Committee), the Baim Institute for Clinical Research (formerly the Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; AEGIS-II executive committee funded by CSL Behring), Belvoir Publications (editor-in-chief, Harvard Heart Letter), the Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (editor-in-chief, Journal of Invasive Cardiology), the Journal of the American College of Cardiology (guest editor, associate editor), Medtelligence/ReachMD (continuing medical education steering committees), the Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and US national coleader, funded by Bayer), Slack Publications (chief medical editor, Cardiology Today’s Intervention), the Society of Cardiovascular Patient Care (secretary/treasurer), WebMD (continuing medical education steering committees); is deputy editor of Clinical Cardiology; is chair of the National Cardiovascular Data Registry ACTION Registry Steering Committee and the VA CART Research and Publications Committee; has received research funding from Abbott, Afimmune, Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Chiesi, CSL Behring, Eisai, Ethicon, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Idorsia, Ironwood, Ischemix, Lexicon, Lilly, Medtronic, PhaseBio, Pfizer, PLx Pharma, Regeneron, Roche, Sanofi, Synaptic, and The Medicines Company; has received royalties from Elsevier (editor, Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease); is a site coinvestigator for Biotronik, Boston Scientific, CSI, St. Jude Medical (now Abbott), and Svelte; is a trustee of the American College of Cardiology; and has conducted unfunded research for FlowCo, Merck, Novo Nordisk, and Takeda. Dr Webb has been a consultant to and has received research funding from Edwards Lifesciences, Abbott Vascular, Boston Scientific, and ViVitro Labs. Dr Reardon serves on an advisory board for Medtronic. Dr Thourani receives grant support, paid to his institution, and advisory fees from Edwards Lifesciences, Boston Scientific, Abbott Vascular, and JenaValve Technology; and receives advisory fees from Gore Vascular. Dr Gleason receives institutional grant support from Medtronic but receives no personal income. Dr Shah has received compensation as a proctor for Edwards Lifesciences; and has received educational grants from Edwards Lifesciences, Medtronic, and Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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

Background: Currently, there is a paucity of information on surgical explantation after transcatheter aortic valve replacement (TAVR)., Objectives: The purpose of this study was to examine the incidence, patient characteristics, predictors, and outcomes of surgical explantation after TAVR using a population-based, nationally representative database., Methods: We analyzed the Medicare Provider profile to include all U.S. patients undergoing TAVR from 2012 to 2017. Time to surgical explant was calculated from the index TAVR discharge to surgical explantation. Post-operative survival was assessed using time-dependent Cox proportional hazard regression analysis and landmark analysis., Results: The incidence of surgical explantation was 0.2% (227 of 132,633 patients), and was 0.28% and 0.14% in the early and newer TAVR era, respectively. The median time to surgical explant was 212 days, whereas 8.8% and 70.9% underwent surgical explantation within 30 days and 1 year, respectively. The primary indication for reintervention was bioprosthetic failure (79.3%). Compared with the no-explant cohort, the explant cohort was significantly younger (mean age 73.7 years vs. 81.7 years), with a lower prevalence of heart failure (55.9% vs. 65.8%) but more likely a lower-risk profile cohort (15% vs. 2.4%; all p < 0.05). The 30-day and 1-year mortality rates were 13.2% and 22.9%, respectively, and did not vary by either time to surgical explant or TAVR era, or between patients with versus without endocarditis (all p > 0.05). The time-dependent Cox regression analysis demonstrated a higher mortality in those with surgical explantation (hazard ratio: 4.03 vs. no-explant group; 95% confidence interval: 1.81 to 8.98). Indication, time-to-surgical-explant, and year of surgical explantation were not associated with worse post-explantation survival (all p > 0.05)., Conclusions: The present study provides updated evidence on the incidence, timing, and outcomes of surgical explantation of a TAVR prosthesis. Although the overall incidence was low, short-term mortality was high. These findings stress the importance of future mechanistic studies on TAVR explantation and may have implications on lifetime management of aortic stenosis, particularly in younger patients., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to evaluate the impact of initial deployment orientation of SAPIEN 3, Evolut, and ACURATE-neo transcatheter heart valves on their final orientation and neocommissural overlap with coronary arteries., Background: Coronary artery access and redo transcatheter aortic valve replacement (TAVR) following initial TAVR may be influenced by transcatheter heart valve orientation. In this study the impact of transcatheter heart valve deployment orientation on commissural alignment was evaluated., Methods: Pre-TAVR computed tomography and procedural fluoroscopy were analyzed in 828 patients who underwent TAVR (483 SAPIEN 3, 245 Evolut, and 100 ACURATE-neo valves) from March 2016 to September 2019 at 5 centers. Coplanar fluoroscopic views were coregistered to pre-TAVR computed tomography to determine commissural alignment. Severe overlap between neocommissural posts and coronary arteries was defined as 0° to 20° apart. The SAPIEN 3 had 1 commissural post crimped at 3, 6, 9, and 12 o'clock. The Evolut "Hat" marker and ACURATE-neo commissural post at deployment were classified as center back (CB), inner curve (IC), outer curve (OC), or center front (CF) and matched with final orientation., Results: Initial SAPIEN 3 crimped orientation had no impact on commissural alignment. Evolut "Hat" at OC or CF at initial deployment had less severe overlap than IC or CB (p < 0.001) against the left main (15.7% vs. 66.0%) and right coronary (7.1% vs. 51.1%) arteries. Tracking Evolut "Hat" at OC of the descending aorta (n = 107) improved OC at deployment from 70.2% to 91.6% (p = 0.002) and reduced coronary artery overlap by 36% to 60% (p < 0.05). ACURATE-neo commissural post at CB or IC during deployment had less coronary artery overlap compared to CF or OC (p < 0.001), with intentional alignment successful in 5 of 7 cases., Conclusions: This is the first systematic evaluation of commissural alignment in TAVR. More than 30% to 50% of cases had overlap with 1 or both coronary arteries. Initial SAPIEN 3 orientation had no impact on alignment, but specific initial orientations of Evolut and ACURATE improved alignment. Optimizing valve alignment to avoid coronary artery overlap will be important in coronary artery access and redo TAVR., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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

Objectives: The aim of this study was to assess the evolution of early outcomes for 3 iterative self-expanding transcatheter aortic valves., Background: Over the past decade there have been rapid advancements in transcatheter aortic valve replacement (TAVR) technologies, including 3 generations of supra-annular self-expanding transcatheter systems., Methods: Data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry for patients undergoing TAVR with CoreValve, Evolut R, or Evolut PRO valves to treat tricuspid aortic stenosis between January 2014 and September 2017 were obtained. Patient risk and echocardiographic data are site reported. Valves analyzed included 23-, 26-, and 29-mm sizes to fit 18- to 26-mm annular diameters. Propensity score matching was performed using the Evolut PRO group as the common reference., Results: Of 18,874 patients undergoing TAVR at 381 centers, 5,514 patients were implanted with CoreValve, 11,295 with Evolut R, and 2,065 with Evolut PRO valves. At 30 days, there were significantly fewer patients with more than mild aortic regurgitation for the unmatched (7.8% CoreValve, 5.2% Evolut R, and 2.8% Evolut PRO; p < 0.001) and matched populations (8.3% CoreValve, 5.4% Evolut R, and 3.4% Evolut PRO; p = 0.032). The mean aortic valve gradients at 30 days in the matched populations were <8 mm Hg for all 3 valves (7.3 mm Hg CoreValve, 7.5 mm Hg Evolut R, 7.2 mm Hg Evolut PRO)., Conclusions: Advancements in transcatheter valve technologies and expanding indications for TAVR have resulted in improved outcomes for patients undergoing TAVR in the United States with self-expanding, supra-annular valves. In particular, the addition of an outer pericardial tissue wrap designed to enhance sealing at the level of the aortic annulus has resulted in very low rates of significant aortic regurgitation while maintaining excellent hemodynamic status., (Copyright © 2020. Published by Elsevier Inc.)

Objectives: The aim of this study was to determine factors affecting paravalvular leak (PVL) in transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli., Background: The largest recommended annular area for the 29-mm S3 is 683 mm 2 . However, experience with S3 TAVR in annuli >683 mm 2 has not been widely reported., Methods: From December 2013 to July 2017, 74 patients across 16 centers with mean area 721 ± 38 mm 2 (range: 684 to 852 mm 2 ) underwent S3 TAVR. The transfemoral approach was used in 95%, and 39% were under conscious sedation. Patient, anatomic, and procedural characteristics were retrospectively analyzed. Valve Academic Research Consortium-2 outcomes were reported., Results: Procedural success was 100%, with 2 deaths, 1 stroke, and 2 major vascular complications at 30 days. Post-dilatation occurred in 32%, with final balloon overfilling (1 to 5 ml extra) in 70% of patients. Implantation depth averaged 22.3 ± 12.4% at the noncoronary cusp and 20.7 ± 9.9% at the left coronary cusp. New left bundle branch block occurred in 17%, and 6.3% required new permanent pacemakers. Thirty-day echocardiography showed mild PVL in 22.3%, 6.9% moderate, and none severe. There was no annular rupture or coronary obstruction. Mild or greater PVL was associated with larger maximum annular and left ventricular outflow tract (LVOT) diameters, larger LVOT area and perimeter, LVOT area greater than annular area, and higher annular eccentricity., Conclusions: TAVR with the 29-mm S3 valve beyond the recommended range by overexpansion is safe, with acceptable PVL and pacemaker rates. Larger LVOTs and more eccentric annuli were associated with more PVL. Longer term follow-up will be needed to determine durability of S3 TAVR in this population., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Importance: With the approval of transcatheter aortic valve replacement (TAVR) for patients with severe symptomatic aortic stenosis at intermediate surgical risk, TAVR volume is projected to increase exponentially in the United States. The 30-day readmission rate for TAVR was recently reported at 17.9%. The association between institutional TAVR volume and the 30-day readmission metric has not been examined., Objective: To assess the association between hospital TAVR volume and 30-day readmission., Design, Setting, and Participants: In this observational study, we used the 2014 Nationwide Readmissions Database to identify hospitals with established TAVR programs (performing at least 5 TAVRs in the first quarter of 2014). Based on annual TAVR volume, hospitals were classified as low (<50), medium (≥50 to <100), and high (≥100) volume. Rates, causes, and costs of 30-day readmissions were compared between low-, medium-, and high-volume hospitals. Data were analyzed from November to December 2016., Exposure: Transcatheter aortic valve replacement., Main Outcomes and Measures: Thirty-day readmissions., Results: Of 129 hospitals included in this study, 20 (15.5%) were categorized as low volume, 47 (36.4%) as medium volume, and 62 (48.1%) as high volume. Of 16 252 index TAVR procedures, 663 (4.1%), 3067 (18.9%), and 12 522 (77.0%) were performed at low-, medium-, and high-volume hospitals, respectively. Thirty-day readmission rates were significantly lower in high-volume compared with medium-volume (adjusted odds ratio, 0.76; 95% CI, 0.68-0.85; P < .001) and low-volume (adjusted odds ratio, 0.75; 95% CI, 0.60-0.92; P = .007) hospitals. Noncardiac readmissions were more common in low-volume hospitals (65.6% vs 60.6% in high-volume hospitals), whereas cardiac readmissions were more common in high-volume hospitals (39.4% vs 34.4% in low-volume hospitals). There were no significant differences in length of stay and costs per readmission among the 3 groups (mean [SD], 5.5 [5.0] days vs 5.9 [7.5] days vs 6.0 [5.8] days; P = .74, and $13 886 [18 333] vs $14 135 [17 939] vs $13 432 [15 725]; P = .63, respectively)., Conclusions and Relevance: We report for the first time, to our knowledge, an inverse association between hospital TAVR volume and 30-day readmissions. Lower readmission at higher-volume hospitals was associated with significantly lower cost to the health care system.