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Background: Transcatheter mitral valve-in-valve replacement offers a less-invasive alternative for high-risk patients with bioprosthetic valve failure. Limited experience exists in intermediate-risk patients. We aim to evaluate 1-year outcomes of the PARTNER 3 mitral valve-in-valve study., Methods: This prospective, single-arm, multicenter study enrolled symptomatic patients with a failing mitral bioprosthesis demonstrating greater than or equal to moderate stenosis and regurgitation and Society of Thoracic Surgeons score ≥3% and <8%. A balloon-expandable transcatheter heart valve (SAPIEN 3, Edwards Lifesciences) was used via a transeptal approach. The primary end point was the composite of all-cause mortality and stroke at 1 year., Results: A total of 50 patients from 12 sites underwent mitral valve-in-valve from 2018 to 2021. The mean age was 70.1±9.7 years, mean Society of Thoracic Surgeons score was 4.1%±1.6%, and 54% were female. There were no primary end point events (mortality or stroke) through 1 year, and no left-ventricular outflow tract obstruction, endocarditis, or mitral valve reintervention was reported. Six patients (12%) required rehospitalization, including heart failure (n=2), minor procedural side effects (n=2), and valve thrombosis (n=2; both resolved with anticoagulation). An additional valve thrombosis was associated with no significant clinical sequelae. From baseline to 1 year, all subjects with available data had none/trace or mild (grade 1+) mitral regurgitation and the New York Heart Association class improved in 87.2% (41/47) of patients., Conclusions: Mitral valve-in-valve with a balloon-expandable valve via transseptal approach in intermediate-risk patients was associated with improved symptoms and quality of life, adequate transcatheter valve performance, and no mortality or stroke at 1-year follow-up., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03193801., Competing Interests: Dr Malaisrie reports institutional research grants from Edwards Lifesciences, Medtronic, and Terumo Medical Corporation and consulting/speaker fees from Edwards Lifesciences, Terumo Medical Corporation, and Artivion; Dr Guerrero reports institutional research grants from Edwards Lifesciences; Dr Davidson reports institutional research grants from Edwards Lifesciences and Abbott Vascular and consulting/speaker fees from Edwards Lifesciences; Dr Williams reports institutional research grants from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific and consulting/speaker fees from Medtronic; Dr de Brito is a proctor for Medtronic, Edwards Lifesciences, and Boston Scientific; Dr Shah reports institutional research grants from Edwards Lifesciences, Medtronic, and Abbott Vascular and consulting/speaker fees from Edwards Lifesciences; Dr Kaneko reports consulting/speaker fees from Edwards Lifesciences, Medtronic, and Abbott Vascular; Dr Poon reports institutional research grants from Edwards Lifesciences and consulting/speaker fees from Edwards Lifesciences and Anteris; Dr Yu is an employee of Edwards Lifesciences; Dr Pibarot reports institutional research grants from Edwards Lifesciences, Medtronic, Pi-Cardia, and Cardiac Success; Dr Hahn reports speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic, and Philips Healthcare; she has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Edwards Lifesciences, Medtronic and Novartis; she is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored tricuspid valve trials, for which she receives no direct industry compensation; Dr Blanke reports consulting/speaker fees from Edwards Lifesciences and LARALAB; Dr Leon reports institutional research grants from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott Vascular; Dr Mack has served as trial coprimary investigator for Edwards Lifesciences and Abbott Vascular and has served as a study chair for Medtronic; Dr Zajarias reports consulting/speaker fees from Edwards Lifesciences and Medtronic. The other authors report no conflicts.

Background: Transcatheter mitral valve replacement (TMVR) is a therapeutic option for patients with severe mitral regurgitation (MR) who are ineligible for conventional surgery. There are limited data on the outcomes of large patient cohorts treated with TMVR., Aims: This study aimed to investigate the outcomes and predictors of mortality for patients treated with transapical TMVR., Methods: This analysis represents the clinical experience of all patients enrolled in the Tendyne Expanded Clinical Study. Patients with symptomatic MR underwent transapical TMVR with the Tendyne system between November 2014 and June 2020. Outcomes and adverse events up to 2 years, as well as predictors of short-term mortality, were assessed., Results: A total of 191 patients were treated (74.1±8.0 years, 62.8% male, Society of Thoracic Surgeons Predicted Risk of Mortality 7.7±6.6%). Technical success was achieved in 96.9% (185/191), and there were no intraprocedural deaths. At 30-day, 1- and 2-year follow-up, the rates of all-cause mortality were 7.9%, 30.8% and 40.5%, respectively. Complete MR elimination (MR <1+) was observed in 99.3%, 99.1% and 96.3% of patients, respectively. TMVR treatment resulted in consistent improvement of New York Heart Association Functional Class and quality of life up to 2 years (both p<0.001). Independent predictors of early mortality were age (odds ratio [OR] 1.11; p=0.003), pulmonary hypertension (OR 3.83; p=0.007), and institutional experience (OR 0.40; p=0.047)., Conclusions: This study investigated clinical outcomes in the full cohort of patients included in the Tendyne Expanded Clinical Study. The Tendyne TMVR system successfully eliminated MR with no intraprocedural deaths, resulting in an improvement in symptoms and quality of life. Continued refinement of clinical and echocardiographic risks will be important to optimise longitudinal outcomes.

Competing Interests: Funding Support and Author Disclosures Dr Wood is a consultant for Edwards Lifesciences and Abbott; and has received research funding from Edwards Lifesciences and Abbott. Dr Leipsic is supported by a Canadian Research Chair in Advanced Cardiopulmonary Imaging; is a consultant for MVRX, Heartflow Inc, and Circle Cardiovascular Imaging; and provides CT core lab services for Edwards Lifesciences, Medtronic, Neovasc, Boston Scientific, and Tendyne Holdings for which no direct compensation is received. Dr Sathananthan has received speaker fees from Edwards Lifesciences; is a consultant for Edwards Lifesciences, Boston Scientific, NVT Medical, and Medtronic; and has received research support from Medtronic, Vivitro Labs, and Edwards Lifesciences. Dr Sellers is a consultant for Edwards Lifesciences, Anteris, Excision Medical, and Medtronic; and has received research support from Medtronic, Vivitro Labs, and Edwards Lifesciences. Dr Webb is a consultant for Edwards Lifesciences; and has received research funding from Edwards Lifesciences, Medtronic, and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Competing Interests: Funding Support and Author Disclosures Dr Wood is a consultant to and has received research funding from Edwards Lifesciences and Abbott. Dr Webb is a consultant for Edwards Lifesciences; and has received research funding from Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Leipsic is supported by a Canadian Research Chair in Advanced Cardiopulmonary Imaging; is a consultant for MVRx, HeartFlow, and Circle Cardiovascular Imaging; and provides computed tomographic core lab services for Edwards Lifesciences, Medtronic, Neovasc, Boston Scientific, and Tendyne Holdings, for which no direct compensation is received. Dr Sathananthan has received speaking fees from Edwards Lifesciences; has received research support from Medtronic, Vivitro Labs, and Edwards Lifesciences; and is a consultant for Edwards Lifesciences, Boston Scientific, NVT, and Medtronic. Dr Sellers is a consultant to Edwards Lifesciences, Anteris Technologies, Excision Medical, and Medtronic; and has received research support from Medtronic, Vivitro Labs, and Edwards Lifesciences. Drs Moss and Boone are consultants for Edwards Lifesciences; and have received speaking fees from Edwards Lifesciences and Abbott Vascular. Dr Akodad is a consultant for Medtronic and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Background: Favourable early outcomes have been reported following valve-in-valve transcatheter mitral valve replacement (TMVR). However, reports of long-term outcomes are lacking. We aimed to evaluate early and late outcomes in a large first-in-human valve-in-valve TMVR 13-year experience., Methods: All patients undergoing valve-in-valve TMVR in our centre from 2008 to 2021 were included. Clinical and echocardiographic outcomes, defined according to the Mitral Valve Academic Research Consortium, were reported., Results: A total of 119 patients were analysed: mean age 76.8 ± 10.2 years, mean Society of Thoracic Surgeons score 10.7 ± 6.8%, 55.4% female, 63.9% transapical access. Thirty-day mortality was 2.5% for the total population and 0.0% after transseptal TMVR. Maximum follow-up was 13.1 years. During a median follow-up of 3.4 years (interquartile range 1.8-5.3 years), 55 patients (46.2%) died, mainly from noncardiovascular causes. Valve hemodynamics were acceptable at 5 years, with 2.5% structural dysfunction. Patients treated from 2016 on (n = 68; 57.1%), following the advent of routine use of the Sapien 3 valve, CT screening, and transseptal access, were compared with those treated before 2016 (n = 51; 42.9%). Patients from 2016 on had a higher technical success rate (100.0% vs 94.1%; P = 0.04), shorter hospitalisation (P < 0.001), trending lower 30-day mortality (1.5% vs 3.9%; P = 0.4) and better 5-year survival (74.7% vs 41.1%; P = 0.03)., Conclusions: Valve-in-valve TMVR can be performed with little morbidity and low mortality. Mid- to long-term survival remains limited owing to advanced age and comorbidities. Structural bioprosthetic valve dysfunction was rare and redo TMVR feasible in selected patients. Outcomes continue to improve, but the role for valve-in-valve TMVR in lower surgical risk patients remains unclear., (Copyright © 2023 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Purpose of Review: Mitral and tricuspid regurgitation represents a clinical challenge. They are associated with a poor prognosis, and many patients are not eligible for conventional surgery. Transcatheter therapies have been the focus of numerous studies and devices over the past decade. Here, we provide a summary of current options for transcatheter treatment of these 2 entities., Recent Findings: Recent studies have demonstrated the benefits of edge-to-edge repair for increasing numbers of patients. Encouraging early results with transcatheter valve replacement are also becoming available. To date, transcatheter edge-to-edge repair is currently the first-line transcatheter treatment for both mitral and tricuspid regurgitation for many patients who are not candidates for surgery. A number of transcatheter replacement devices are under development and clinical investigation but, for the most part, their current use is limited to compassionate cases or clinical trials., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Competing Interests: Funding Support and Author Disclosures Dr Wood is a consultant to, and has received research funding from Edwards Lifesciences and Abbott. Dr Sellers is a consultant to Edwards Lifesciences, Anteris, Excision Medical, and Medtronic; and has received research support from Medtronic, Vivitro Labs, and Edwards Lifesciences. Dr Leipsic is supported by a Canadian Research Chair in Advanced Cardiopulmonary Imaging, consults for MVRX, HeartFlow Inc., and Circle Cardiovascular Imaging; and provides CT core lab services for Edwards Lifesciences, Medtronic, Neovasc, Boston Scientific, and Tendyne Holdings, for which no direct compensation is received. Dr Sathananthan has received speaking fees from Edwards Lifesciences; has received research support from Medtronic, Vivitro Labs, and Edwards Lifesciences; and is a consultant for Edwards Lifesciences, Boston Scientific, NVT Medical and Medtronic. Dr Webb is a consultant for Edwards Lifesciences and receives research funding from Edwards Lifesciences, Medtronic, and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Mitral annular calcium (MAC) with severe mitral valvular dysfunction presents a complex problem, as valve replacement, either surgical or transcatheter, is challenging because of anatomy, technical considerations, concomitant comorbidities, and advanced age. The authors review the clinical and anatomical features of MAC that are favorable (green light), challenging (yellow light), or prohibitive (red light) for surgical or transcatheter mitral valve interventions. Under the auspices of the Heart Valve Collaboratory, an expert working group of cardiac surgeons, interventional cardiologists, and interventional imaging cardiologists was formed to develop recommendations regarding treatment options for patients with MAC as well as a proposed grading and staging system using both anatomical and clinical features., Competing Interests: Funding Support and Author Disclosures Dr Wang is a consultant for Abbott, Edwards Lifesciences, Boston Scientific, and NeoChord; and has received research grant support from Boston Scientific assigned to Henry Ford Health. Dr Cavalcante has received consulting fees from Abbott Structural, Anteris, AriaCV, Boston Scientific, Edwards Lifesciences, Medtronic, VDyne, W.L. Gore, and XyloCor; and has received research grant support from Abbott Northwestern Hospital Foundation. Dr Tang is a physician proctor and consultant for Medtronic; is a consultant and advisory board member for Abbott Structural Heart; is a consultant for NeoChord; is a physician advisory board member for Boston Scientific and JenaValve; and has received speaker honoraria from Siemens Healthineers. Dr Ailawadi is a consultant for Edwards Lifesciences, Medtronic, Abbott, W.L. Gore, Anteris, Johnson & Johnson, Philips, Artivion, and AtriCure; and holds equity in Anteris, Triflo, and xDot. Dr Lim has received institutional research grant support from Abbott, Boston Scientific, Corvia, Edwards Lifesciences, Medtronic, Trisol, and V-Wave; has received consulting fees from Philips, Valgen, and Venus. Dr George has received consulting honoraria from Zimmer Biomet, AtriCure, Neptune Medical, Abbvie, Johnson & Johnson, and Boston Scientific; has served on advisory boards for Edwards Surgical, Medtronic Surgical, Trisol Medical, Abbvie, Johnson & Johnson, Foldax Medical, Zimmer Biomet, Abbvie, and Boston Scientific; holds equity in Valcare Medical, Durvena, CardioMech, VDyne, MitreMedical, and MITRx; and has received institutional funding to Columbia University from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter mitral valve implantation (TMVI) is a novel therapeutic option for treating symptomatic mitral valve disease. Evaluating patient anatomical suitability is a critical step in the TMVI screening process, but currently requires specialized software and computerized device models., Aims: This analysis sought to assess the effectiveness of simple and standardized multislice computed tomography (MSCT) anatomic measurements for their ability to discriminate between patients who passed anatomical screening for Tendyne™ TMVI., Methods: Subjects screened for the Tendyne Expanded Clinical Study from January 2016 through September 2019 were included. Core laboratory screening measurements included mitral annular (MA) dimensions at end-systole and end-diastole, simulated device implantation, and neo-left ventricular outflow tract (LVOT) area. Additionally, nine standard measurements of patient anatomy were assessed for their predictive value of patients passing the anatomic screening process., Results: Out of 496 subjects screened for eligibility, 257 subjects met clinical eligibility criteria with MA dimensions within the manufacturer's suggested range: 153 (59.5%) underwent TMVI while 104 (40.5%) were excluded from the study for other anatomic reasons (76% due to risk of LVOT obstruction). CT-derived left ventricular end-systole diameter (LVESD) had the highest discriminatory power for predicting TMVI anatomical suitability (area under the curve of 0.908, p < 0.0001). The mitral inter-commissural (IC) dimension was best predictive of annular dimensions being within range, with dimensions <30 or >50 mm resulting in a negative predictive value of 94.4%., Conclusions: MSCT-derived mitral IC dimension and LVESD easily performed measures that are effective predictors of anatomical suitability or screen failure for this tether-based TMVI device., (© 2023 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Background: Current expected normal echocardiographic measures of transcatheter heart valve (THV) function were derived from pooled cohorts of the randomized trials; however, THV function by flow state before or following transcatheter aortic valve replacement (TAVR) has not been previously reported., Objectives: This study sought to assess the expected normal echocardiographic hemodynamics for the balloon-expandable THV grouped by stroke volume index (SVI)., Methods: Patients with severe aortic stenosis enrolled in PARTNER (Placement of Aortic Transcatheter Valves) 1 (high/extreme surgical risk), PARTNER 2 (intermediate surgical risk), or PARTNER 3 (low surgical risk) trials with complete core laboratory echocardiography were included. Patients were grouped by low-flow (SVI LOW  <35 mL/m 2 ) and normal-flow (SVI NORMAL  ≥35 mL/m 2 ). Mean gradient, effective orifice area (EOA), and Doppler velocity index (DVI) were collected at baseline and at 30 days post-TAVR. Prosthesis-patient mismatch (PPM) was both calculated and predicted from normative data, using defined criteria., Results: In the entire population (N = 4,991), mean age was 81.8 years, 58% of patients were male, and 42% had low flow. Compared with patients with baseline SVI NORMAL , those with SVI LOW were more likely to be male; have more comorbidities; and lower left ventricular ejection fraction, mean gradient, and EOA. Post-TAVR, SVI LOW increased to SVI NORMAL in 17.3% and SVI NORMAL decreased to SVI LOW in 12.3% of patients. Using baseline SVI, follow-up EOA, mean gradient, and DVI for patients with SVI LOW tended to be lower than for patients with SVI NORMAL . Using the post-TAVR SVI, follow-up EOA, mean gradient, and DVI were significantly lower for patients with SVI LOW than for those with SVI NORMAL (P < 0.001 for all). The incidence of calculated, but not predicted, severe PPM was higher in patients with low flow than it was in patients with normal flow, suggesting pseudo-PPM in the presence of low flow., Conclusions: This study demonstrates that flow affects THV hemodynamics and both baseline and follow-up SVI should be considered when predicting THV hemodynamics prior to TAVR, as well as assessing valve function following valve implantation., Competing Interests: Funding Support and Author Disclosures Dr Pibarot has received funding from Edwards Lifesciences, Medtronic, Pi-Cardia, and Cardiac Phoenix for echocardiography core laboratory analyses and research studies in the field of transcatheter valve therapies, for which he received no personal compensation; and has received lecture fees from Edwards Lifesciences and Medtronic. Dr Leipsic has served as a consultant to Circle CVI and HeartFlow; and has institutional core laboratory contracts with Edwards Lifesciences, Medtronic, Boston Scientific, Abbott, PI-Cardia, and Conformal. Dr Hahn has received speaker fees from Abbott Vascular, Baylis Medical, and Edwards Lifesciences; has performed institutional consulting for Abbott Structural, Edwards Lifesciences, and Medtronic; has equity in 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 receives no direct industry compensation. 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: Funding Support and Author Disclosures Funding was received from St Paul's Foundation and the Providence Health Care Research Institute (PHCRI) Early Career Research Initiative. Dr Akodad has received research funding from Medtronic, Biotronik, MUSE Explore, and Federation Française de Cardiologie. Dr Sathananthan has received speaker fees from Edwards Lifesciences and NVT Medical; and has reported consulting for Edwards Lifesciences, Boston Scientific, and Medtronic. Dr Tzimas has reported support from the Fondation Vaudoise de Cardiologie. Dr Gulsin has reported support from a British Heart Foundation Travel Fellowship (FS/TF/21/33008). Dr Blanke has reported consulting for Edwards Lifesciences, Boston Scientific, and Neovasc; and has provided computed tomography core laboratory services for Edwards Lifesciences, Medtronic, Neovasc, Boston Scientific, and Abbott, for which no direct compensation was received. Dr Sondergaard has received consultant fees and/or institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and SMT. Dr Wood has reported consulting for and has received research funding from Edwards Lifesciences and Abbott. Dr Webb has reported consulting for Edwards Lifesciences. Dr Leipsic has reported support from a Canadian Research Chair in Advanced Cardiopulmonary Imaging; has reported consulting for MVRX, HeartFlow, and Circle Cardiovascular Imaging; and has provided computed tomography core laboratory services for Edwards Lifesciences, Medtronic, Neovasc, Boston Scientific, and Abbott, for which no direct compensation is received. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Background: Treatment of mitral regurgitation (MR) associated with severe mitral annular calcification (MAC) is challenging due to the high risk of fatal atrioventricular groove disruption and significant paravalvular leak., Aims: The aim of this study was to evaluate the outcomes of transcatheter mitral valve replacement (TMVR) with the Tendyne valve (Abbott Structural) in patients with MR and MAC., Methods: Twenty patients (mean age 78 years; 11 women) who were treated with the Tendyne valve, either compassionate use (CU; closed) or as part of The Feasibility Study of Tendyne in MAC (NCT03539458), had reported outcomes in a median follow-up duration of 368 days., Results: In all patients, a valve was implanted with no procedural mortality and successful hospital discharge. Two embolic events occurred, including one with mesenteric ischaemia and one non-disabling stroke. At 30 days and one year, all-cause mortality occurred in one (5%) and eight patients (40%), respectively. At one year, six patients had been hospitalised for heart failure (30%). There was no prosthetic dysfunction, and MR remained absent in all patients at one year. Clinical improvement, measured by New York Heart Association Functional Class, occurred in 11 of 12 patients who were alive at one year. Among seven survivors with Kansas City Cardiomyopathy Questionnaire (KCCQ) data, mean increase in KCCQ score was 29.9±26.3 at one year with improvement of ≥10 points in five (71.4%) patients., Conclusions: In patients with MR and severe MAC, TMVR with the Tendyne valve was associated with encouraging acute outcomes, midterm durability, and clinical improvement. Dedicated TMVR therapy may have a future role in these anatomically challenging, high-risk patients.

Aims: To characterize the dynamic nature of the left ventricular outflow tract (LVOT) geometry and flow rate in patients following transcatheter mitral valve replacement (TMVR) with anterior leaflet laceration (LAMPOON) and derive insights to help guide future patient selection., Methods and Results: Time-resolved LVOT geometry and haemodynamics were analysed with post-procedure computed tomography and echocardiography in subjects (N = 19) from the LAMPOON investigational device exemption trial. A novel post hoc definition for LVOT obstruction was employed to account for systolic flow rate and quality of life improvement [obstruction was defined as LVOT gradient >30 mmHg or LVOT effective orifice area (EOA) ≤1.15 cm2]. The neo-LVOT and skirt neo-LVOT were observed to vary substantially in area throughout systole (64 ± 27% and 25 ± 14% change in area, respectively). The peak systolic flow rate occurred most commonly just prior to mid-systole, while minimum neo-LVOT (and skirt neo-LVOT) area occurred most commonly in early-diastole. Subjects with LVOT obstruction (n = 5) had smaller skirt neo-LVOT values across systole. Optimal thresholds for skirt neo-LVOT area were phase-specific (260, 210, 200, and 180 mm2 for early-systole, peak flow, mid-systole, and end-systole, respectively)., Conclusion: The LVOT geometry and flow rate exhibit dynamic characteristics following TMVR with LAMPOON. Subjects with LVOT obstruction had smaller skirt neo-LVOT areas across systole. The authors recommend the use of phase-specific threshold values for skirt neo-LVOT area to guide future patient selection for this procedure. LVOT EOA is a 'flow-independent' metric which has the potential to aid in characterizing LVOT obstruction severity., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)

Since the first-in-human procedure in 2002, transcatheter aortic valve implantation (TAVI) has become a well-established therapeutic option for severe aortic stenosis, and is offered increasingly to patients at lower surgical risk, who are typically younger. Increasing lifespan carries concerns that "minor" complications that may have little impact in elderly patients could have a greater long-term impact in younger patients. Issues such as mild paravalvular regurgitation, hypoattenuated leaflet thickening, atrioventricular block with need for permanent pacemaker implantation or future coronary access may have a substantial cumulative undesirable impact. Additionally, as with surgical bioprosthetic valves, transcatheter bioprosthetic valves will eventually degenerate, and may require repeat intervention. Although durability data for transcatheter heart valves (THVs) is encouraging, very late data are lacking. Redo TAVI has been shown to be feasible with acceptable outcomes in patients with failed THVs, but in some patients, anatomical or device considerations may preclude a repeatable procedure because of the risk of coronary obstruction. Various strategies for lifetime management in this lower-risk and younger population have been proposed: surgical aortic valve replacement (SAVR) first, followed by TAVI; TAVI then SAVR; TAVI then TAVI, etc. A tailored approach may be considered according to patient co-morbidities, anatomy and the relative advantages and disadvantages of the two therapies. This review offers an overview of current challenges when considering TAVI in populations at lower risk, and summarizes the different approaches that have been developed to address these concerns., (Copyright © 2022 Elsevier Masson SAS. All rights reserved.)

Background: Transcatheter mitral valve replacement (TMVR) is feasible for selected patients with severe mitral regurgitation (MR) who are poor candidates for valve surgery. Intermediate-term to long-term TMVR outcomes have not been reported., Objectives: This study sought to evaluate the safety and effectiveness through 2-year follow-up of TMVR in high-surgical-risk patients with severe MR., Methods: The first 100 patients enrolled in the Expanded Clinical Study of the Tendyne Mitral Valve System, an open-label, nonrandomized, prospective study of transapical TMVR, were followed for 2 years., Results: The patients (aged 74.7 ± 8.0 years, 69.0% male) had symptomatic (66.0% New York Heart Association [NYHA] functional class III or IV) grade 3+ or 4+ MR that was secondary or mixed in 89 (89.0%). Prostheses were successfully implanted in 97 (97.0%) patients. At 2 years, all-cause mortality was 39.0%; 17 (43.6%) of 39 deaths occurred during the first 90 days. Heart failure hospitalization (HFH) fell from 1.30 events per year preprocedure to 0.51 per year in the 2 years post-TMVR (P < 0.0001). At 2 years, 93.2% of surviving patients had no MR. No patient had >1+ MR. The improvement in symptoms at 1 year (88.5% NYHA functional class I or II) was sustained to 2 years (81.6% NYHA functional class I or II). Among survivors, the left ventricular ejection fraction was 45.6 ± 9.4% at baseline and 39.8 ± 9.5% at 2 years (P = 0.0012). Estimated right ventricular systolic pressure decreased from 47.6 ± 8.6 mm Hg to 32.5 ± 10.4 mm Hg (P < 0.005)., Conclusions: In this study, the impact of TMVR on severity of MR, reduction in HFH rate, and improvement in symptoms was sustained through 2 years. All-cause mortality and the need for HFH was highest in the first 3 months postprocedure. (Expanded Clinical Study of the Tendyne Mitral Valve System; NCT02321514)., Competing Interests: Funding Support and Author Disclosures The present paper is an analysis of the first 100 patients treated in the Expanded Clinical Study of the Tendyne Mitral Valve System (Global Feasibility Study; NCT02321514) supported by Abbott. Dr Muller has served as a consultant for Medtronic, Abbott, and Edwards Lifesciences; and has received research grant support from Abbott and Medtronic. Dr Sorajja has served as a consultant for Abbott Structural, Boston Scientific, and Medtronic. Dr Duncan has served as a proctor and consultant for Abbott, Edwards Lifesciences, Medtronic, and Neochord. Dr Bethea has served as a consultant for Abbott. Dr Grayburn has served as a consultant for Abbott, Edwards Lifesciences, Valtech Cardio, and Neochord; and has received research grants from Abbott, Boston Scientific, Medtronic, Edwards Lifesciences, Valtech Cardio, and Neochord. Drs Babaliaros and Denti have served as a consultant for Edwards Lifesciences and Abbott. Dr Guerrero has served as a consultant for Edwards Lifesciences and Abbott; and has received research grant support from Edwards Lifesciences. Dr Thourani has served as a consultant for and received research grant support from Abbott. Dr Dumonteil has served as a proctor and consultant for Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Modine has served as a proctor and consultant for Abbott, Edwards Lifesciences, and Medtronic. Dr Blanke has received institutional grant support from Edwards Lifesciences, Abbott, Medtronic, Boston Scientific, MVRX, and Neovasc. Dr Leipsic has received institutional grant support from Edwards Lifesciences, Abbott, Medtronic, Boston Scientific, MVRX, and Neovasc. Dr Badhwar has served as an uncompensated consultant for 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: Transcatheter heart valve (THV) dysfunction with an elevated gradient or paravalvular leak (PVL) may be documented late after THV implantation. Medical management, paravalvular plugs, redo THV replacement, or surgical valve replacement may be considered. However, late balloon dilatation is rarely utilized because of concerns about safety or lack of efficacy.Objectives: We aimed to evaluate the safety and efficacy of late dilatation in the management of THV dysfunction.Methods: All patients who underwent late dilatation for symptomatic THV dysfunction at 2 institutions between 2016 and 2021 were identified. Baseline, procedural characteristics, and clinical and echocardiographic outcomes were documented. THV frame expansion was assessed by multislice computed tomography before and after late dilatation.Results: Late dilatation was performed in 30 patients a median of 4.6 months (IQR: 2.3-11.0 months) after THV implantation in the aortic (n = 25; 83.3%), mitral (n = 2; 6.7%), tricuspid (n = 2; 6.7%) and pulmonary (n = 1; 3.3%) position. THV underexpansion was documented at baseline, and frame expansion substantially improved after late dilatation. The mean transvalvular gradient fell in all patients. For aortic THVs specifically, mean transaortic gradient fell from 25.4 ± 13.9 mm Hg to 10.8 ± 4.1 mm Hg; P < 0.001. PVL was reduced to ≤mild in all 11 patients with a previous >mild PVL. Embolic events, stroke, annular injury, and bioprosthetic leaflet injury were not observed. Symptomatic benefit was durable at 19.6 months (IQR: 14.8-36.1 months) follow-up.Conclusions: Balloon dilatation late after THV implantation appears feasible and safe in appropriately selected patients and may result in THV frame expansion resulting in improvements in hemodynamic performance and PVL. [ABSTRACT FROM AUTHOR]

(1) Background: Early hypo-attenuated leaflet thickening (HALT) is diagnosed by computed tomography angiography (CTA) in approximately 15% of patients undergoing transcatheter aortic valve replacement (TAVR). We sought to investigate the diagnostic performance of CTA for the diagnosis of HALT, focusing on timing data assessment within the cardiac cycle. (2) Methods: The study enrolled 50 patients with and 50 without HALT with available post-TAVR-CTA. The primary objective was to compare the diagnostic performance of CTA readings at specific intervals and time points during the cardiac cycle (entire systole, entire diastole, end-systole, and mid-diastole) versus gold standard (consensus reading by two observers based on multiphase full cardiac cycle data sets). (3) Results: 100 CTAs were independently analysed by two observers blinded to clinical characteristics of the study population and the results from the gold standard reading. Sensitivity and specificity for the diagnosis of HALT were 84%/94% in systole, 87%/92% in diastole, 78%/95% at end-systole, and 80%/94% at mid-diastole. End-systole had the highest positive predictive value (0.88) and positive likelihood ratio (36). Cohen's kappa for interobserver reliability was 0.715 in systole, 0.578 in diastole, 0.650 at end-systole, and 0.517 at mid-diastole. (4) Conclusion: Limiting CTA reading to distinct intervals or time points during the cardiac cycle has good specificity but lowers sensitivity. For a reliable diagnosis of HALT, data sets from a multiphase CTA covering the entire cardiac cycle should be analysed. A double reader approach would be desirable in further studies investigating HALT. [ABSTRACT FROM AUTHOR]