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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.

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.)

Objectives: The aim of this study was to assess the association between Doppler velocity index (DVI) and 2-year outcomes for balloon-expandable SAPIEN 3 transcatheter aortic valve replacement (TAVR) and for surgical aortic valve replacement (SAVR)., Background: DVI >0.35 is normal for a prosthetic valve, but recent studies suggest that DVI <0.50 is associated with poor outcomes following TAVR., Methods: Patients with severe aortic stenosis enrolled in the PARTNER (Placement of Aortic Transcatheter Valve) 2 (intermediate surgical risk) or PARTNER 3 (low surgical risk) trial undergoing TAVR (n = 1,450) or SAVR (n = 1,303) were included. Patients were divided into 3 DVI groups on the basis of core laboratory-assessed discharge or 30-day echocardiograms: DVI LOW (≤0.35), DVI INTERMEDIATE (>0.35 to ≤0.50), and DVI HIGH (>0.50). Two-year outcomes were assessed., Results: Following TAVR, there were no differences among the 3 DVI groups in composite outcomes of death, stroke, or rehospitalization or in any individual components of 2-year outcomes (P > 0.70 for all). Following SAVR, there was no difference among DVI groups in the composite outcome (P = 0.27), but there was a significant association with rehospitalization (P = 0.02). Restricted cubic-spline analysis for combined outcomes showed an increased risk with post-SAVR DVI ≤0.35 but no relationship post-TAVR. DVI ≤0.35 was associated with increased 2-year composite outcome for SAVR (HR: 1.81; 95% CI: 1.29-2.54; P < 0.001), with no adverse outcomes for TAVR (P = 0.86)., Conclusions: In intermediate- and low-risk cohorts of the PARTNER trials, DVI ≤0.35 predicted worse 2-year outcomes following SAVR, driven primarily by rehospitalization, with no adverse outcomes associated with DVI following TAVR with the balloon-expandable SAPIEN 3 valve., Competing Interests: Funding Support and Author Disclosures Dr Hahn has received speaker fees from Edwards Lifesciences and Philips Healthcare; has received consulting fees from Abbott Structural, Edwards Lifesciences, Medtronic, and Navigate; has received nonfinancial support from 3mensio; holds equity with Navigate; and is chief scientific officer for the echocardiography core laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr Thourani has received grant support from Edwards Lifesciences; and has served as an adviser for Edwards Lifesciences. Dr Jaber has echocardiography core laboratory contracts with Edwards Lifesciences, for which he receives no direct compensation. Dr Leipsic has received grant support from Abbott and Medtronic; has received consulting fees and stock options from Circle Cardiovascular Imaging; and provides cardiac computed tomography core laboratory services for Edwards Lifesciences, Tendyne, Medtronic, and Abbott, for which he does not receive any direct compensation. Dr Thourani does research and is a consultant for Abbott Vascular, Allergen, Boston Scientific, CryoLife, Edwards Lifesciences, Gore Vascular, and JenaValve. Dr Makkar has received grant support from Abbott and Edwards Lifesciences. Dr Kodali has received equity from BioTrace Medical, Dura Biotech, and Thubrikar Aortic Valve; has received grant support from Medtronic and Boston Scientific; has received grant support and consulting fees from Abbott Vascular; and has received consulting fees from Claret Medical, Admedus, and Meril Life Sciences. Dr Clavel has received research grants from Edwards Lifesciences and Medtronic. Dr Khalique has received consulting fees from Edwards Lifesciences, JenaValve, and Abbott. Dr Weissman has core laboratory contracts with Abbott, Neovasc, Ancora, Medtronic, Boston Scientific, Edwards Lifesciences, Biotronik, and LivaNova, for which he receives no direct compensation. Dr Blanke has received consulting fees from Edwards Lifesciences, Tendyne (Abbott), Circle Cardiovascular Imaging, Neovasc, and Gore; and provides cardiac computed tomography core laboratory services for Edwards Lifesciences, Tendyne, Medtronic, and Abbott, for which he does not receive any direct compensation. Dr Chen is an employee of Edwards Lifesciences. Dr Mack is the co–principal investigator of the PARTNER 3 Trial (Edwards Lifesciences); is the co–principal investigator of the COAPT trial (Abbott); and is study chair of the APOLLO trial (Medtronic), all uncompensated. Dr Leon has received grant support, paid to his institution, from Edwards Lifesciences, Medtronic, Abbott, and Boston Scientific; and has received advisory board fees from Medtronic, Abbott, Boston Scientific, Gore, and Meril Life Sciences. Dr Pibarot holds the Canada Research Chair in Valvular Heart Diseases; has a Foundation Scheme Grant (FDN-143225) from Canadian Institutes of Health Research; has a grant from the Foundation of the Quebec Heart and Lung Institute; and has echocardiography core laboratory contracts with Edwards Lifesciences, for which he receives no direct compensation. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021. Published by Elsevier Inc.)

Competing Interests: Funding support and Author Disclosures Dr Chuang is funded by the Royal Australasian College of Physicians Vincent Fairfax Research Entry Scholarship. Dr Chatfield is funded by the New Zealand Heart Foundation and John Ormiston Scholarship. Dr Akodad has received funding from Fédération Française de cardiologie, MUSE-Explore, and Biotronik. Drs Wood, Webb, and Ye have been consultants to Edwards Lifesciences. Dr Sathananthan has been a consultant to Edwards Lifesciences and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Objectives: This study aimed to compare incidence and impact of measured prosthesis-patient mismatch (PPM M ) versus predicted PPM (PPM P ) after surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR)., Background: TAVR studies have used measured effective orifice area indexed (EOAi) to body surface area (BSA) to define PPM, but most SAVR series have used predicted EOAi. This difference may contribute to discrepancies in incidence and outcomes of PPM between series., Methods: The study analyzed SAVR patients from the PARTNER (Placement of Aortic Transcatheter Valves) 2A trial and TAVR patients from the PARTNER 2 SAPIEN 3 Intermediate Risk registry. PPM was classified as moderate if EOAi ≤0.85 cm 2 /m 2 (≤0.70 if obese: body mass index ≥30 kg/m 2 ) and severe if EOAi ≤0.65 cm 2 /m 2 (≤0.55 if obese). PPM M was determined by the core lab-measured EOAi on 30-day echocardiogram. PPM P was determined by 2 methods: 1) using normal EOA reference values previously reported for each valve model and size (PPM P1 ; n = 929 SAVR, 1,069 TAVR) indexed to BSA; and 2) using normal reference EOA predicted from aortic annulus size measured by computed tomography (PPM P2 ; n = 864 TAVR only) indexed to BSA. Primary endpoint was the composite of 5-year all-cause death and rehospitalization., Results: The incidence of moderate and severe PPM P was much lower than PPM M in both SAVR (PPM P1 : 28.4% and 1.2% vs. PPM M : 31.0% and 23.6%) and TAVR (PPM P1 : 21.0% and 0.1% and PPM P2 : 17.0% and 0% vs. PPM M : 27.9% and 5.7%). The incidence of severe PPM M and severe PPM P1 was lower in TAVR versus SAVR (P < 0.001). The presence of PPM by any method was associated with higher transprosthetic gradient. Severe PPM P1 was independently associated with events in SAVR after adjustment for sex and Society of Thoracic Surgeons score (hazard ratio: 3.18;95% CI: 1.69-5.96; P < 0.001), whereas no association was observed between PPM by any method and outcomes in TAVR., Conclusions: EOAi measured by echocardiography results in a higher incidence of PPM following SAVR or TAVR than PPM based on predicted EOAi. Severe PPM P is rare (<1.5%), but is associated with increased all-cause death and rehospitalization after SAVR, whereas it is absent following TAVR., Competing Interests: Funding Support and Author Disclosures The PARTNER II trial was funded by Edwards Lifesciences. Dr Pibarot has echo core lab contracts with Edwards Lifesciences, for which he receives no direct compensation. Dr Leipsic holds institutional computed tomography core lab contracts with Edwards Lifesciences, Abbott, Medtronic; and has served as a consultant for Edwards Lifesciences. Dr Clavel has a computed tomography core lab contract with Edwards Lifesciences, for which he receives no direct compensation; and has received research grant support from Medtronic. Dr Khalique has received speaker fees from Edwards Lifesciences. Dr Abbas has served on the on the Speakers Bureau and has received research grants from Edwards Lifesciences. Dr Hahn has echo core lab contracts with Edwards Lifesciences, for which she receives no direct compensation. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Aims: The Valve Academic Research Consortium (VARC), founded in 2010, was intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. Rapid evolution of the field, including the emergence of new complications, expanding clinical indications, and novel therapy strategies have mandated further refinement and expansion of these definitions to ensure clinical relevance. This document provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research., Methods and Results: Several years after the publication of the VARC-2 manuscript, an in-person meeting was held involving over 50 independent clinical experts representing several professional societies, academic research organizations, the US Food and Drug Administration (FDA), and industry representatives to (i) evaluate utilization of VARC endpoint definitions in clinical research, (ii) discuss the scope of this focused update, and (iii) review and revise specific clinical endpoint definitions. A writing committee of independent experts was convened and subsequently met to further address outstanding issues. There were ongoing discussions with FDA and many experts to develop a new classification schema for bioprosthetic valve dysfunction and failure. Overall, this multi-disciplinary process has resulted in important recommendations for data reporting, clinical research methods, and updated endpoint definitions. New definitions or modifications of existing definitions are being proposed for repeat hospitalizations, access site-related complications, bleeding events, conduction disturbances, cardiac structural complications, and bioprosthetic valve dysfunction and failure (including valve leaflet thickening and thrombosis). A more granular 5-class grading scheme for paravalvular regurgitation (PVR) is being proposed to help refine the assessment of PVR. Finally, more specific recommendations on quality-of-life assessments have been included, which have been targeted to specific clinical study designs., Conclusions: Acknowledging the dynamic and evolving nature of less-invasive aortic valve therapies, further refinements of clinical research processes are required. The adoption of these updated and newly proposed VARC-3 endpoints and definitions will ensure homogenous event reporting, accurate adjudication, and appropriate comparisons of clinical research studies involving devices and new therapeutic strategies., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)

With the advent of transcatheter mitral valve replacement (TMVR), the concept of the neo-left ventricular outflow tract (LVOT) was introduced and remains an essential component of treatment planning. This paper describes the LVOT anatomy and provides a step-by-step computed tomography methodology to segment and measure the neo-LVOT while discussing the current evidence and outstanding challenges. It also discusses the technical and hemodynamic factors that play a major role in assessing the neo-LVOT. A summary of expert-based recommendations about the overall risk of LVOT obstruction in different scenarios is presented along with the currently available methods to reduce the risk of LVOT obstruction and other post-procedural complications., Competing Interests: Funding Support and Author Disclosures Dr. Wang has served as a consultant for Edwards Lifesciences and Boston Scientific; has received research grant support from Boston Scientific; and had patents on left ventricular outflow tract prediction modeling software assigned to assigned to her employer (Henry Ford Health System). Dr. Piazza is a consultant for Medtronic, HighLife, MicroPort, and Circle CVI. Dr. Cavalcante has received institutional grants to provide core lab services and consultant services to Boston Scientific, Edwards LifeSciences, and Abbott Structural; and received research support from 3Mensio, Circle CVI, Medis, and Siemens Healthineers. Drs. Blanke and Leipsic have received institutional grants to provide core lab services from Edwards Lifesciences, Medtronic, and Abbott; and served as consultants to Circle CVI and MVRX. Dr. Blanke has served as a consultant to Edwards Lifesciences 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.)

Growing clinical data support the use of transcatheter therapies for significant mitral valve disease. Currently, edge-to-edge repair is the transcatheter treatment of choice, but many anatomies are not suitable. Transcatheter mitral valve replacement offers several potential advantages over transcatheter repair, most notably a greater and more sustained reduction in mitral regurgitation post-implantation, but also potential disadvantages. To enable the successful treatment of mitral valve disease in a wide range of patients and anatomies, we require an armory of transcatheter devices, including transcatheter mitral valve replacement systems., Competing Interests: Funding Support and Author Disclosures Dr. Sathananthan is a consultant to Edward Lifesciences and Medtronic. Dr. Ye is a consultant to Edwards Lifesciences. Dr. Cheung is a consultant to Abbott Vascular, Medtronic, and Neovasc. Dr. Webb is a consultant to Edwards Lifesciences, Abbott Vascular, and Boston Scientific. Dr. Blanke is a consultant to Edwards Lifesciences, Tendyne, Neovasc, Circle Cardiovascular Imaging, and Gore. Dr. Leipsic is a consultant to Edwards Lifesciences, Neovasc, Abbott, Medtronic, and GE Healthcare; and has been a consultant to and holds stock in Circle Cardiovascular Imaging and HeartFlow. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Crown Copyright © 2021. Published by Elsevier Inc. All rights reserved.)

Background: Surgical aortic valve replacement and transcatheter aortic valve replacement (TAVR) are now both used to treat aortic stenosis in patients in whom life expectancy may exceed valve durability. The choice of initial bioprosthesis should therefore consider the relative safety and efficacy of potential subsequent interventions., Objectives: The aim of this study was to compare TAVR in failed transcatheter aortic valves (TAVs) versus surgical aortic valves (SAVs)., Methods: Data were collected on 434 TAV-in-TAV and 624 TAV-in-SAV consecutive procedures performed at centers participating in the Redo-TAVR international registry. Propensity score matching was applied, and 330 matched (165:165) patients were analyzed. Principal endpoints were procedural success, procedural safety, and mortality at 30 days and 1 year., Results: For TAV-in-TAV versus TAV-in-SAV, procedural success was observed in 120 (72.7%) versus 103 (62.4%) patients (p = 0.045), driven by a numerically lower frequency of residual high valve gradient (p = 0.095), ectopic valve deployment (p = 0.081), coronary obstruction (p = 0.091), and conversion to open heart surgery (p = 0.082). Procedural safety was achieved in 116 (70.3%) versus 119 (72.1%) patients (p = 0.715). Mortality at 30 days was 5 (3%) after TAV-in-TAV and 7 (4.4%) after TAV-in-SAV (p = 0.570). At 1 year, mortality was 12 (11.9%) and 10 (10.2%), respectively (p = 0.633). Aortic valve area was larger (1.55 ± 0.5 cm 2 vs. 1.37 ± 0.5 cm 2 ; p = 0.040), and the mean residual gradient was lower (12.6 ± 5.2 mm Hg vs. 14.9 ± 5.2 mm Hg; p = 0.011) after TAV-in-TAV. The rate of moderate or greater residual aortic regurgitation was similar, but mild aortic regurgitation was more frequent after TAV-in-TAV (p = 0.003)., Conclusions: In propensity score-matched cohorts of TAV-in-TAV versus TAV-in-SAV patients, TAV-in-TAV was associated with higher procedural success and similar procedural safety or mortality., Competing Interests: Author Disclosures Dr. Webb is a consultant to and has received research funding from Edwards Lifesciences, Abbott Vascular, Boston Scientific, and ViVitro Labs. Dr. Kim has received proctor or speaker fees from Boston Scientific, Abbott, Edwards Lifesciences, and Medtronic. Dr. Barbanti is a consultant for Edwards; and is an Advisory Board member for Biotronik. Dr. Sondergaard has received consultant fees and institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Symetis. Dr. Redwood is a proctor for and has received lecture fees from Edwards. Dr. Hamm is an Advisory Board member for Medtronic. Dr. Sinning has received speaker honoraria and research grants from Medtronic, Boston Scientific, and Edwards Lifesciences. Dr. Wood is a consultant to and has received research funding from Edwards Lifesciences, Abbott Vascular, and Boston Scientific. Dr. Sathananthan is a consultant to Edwards Lifesciences. Dr. Schofer has received speaker fees and travel compensation from Boston Scientific; and has received travel compensation from Edwards Lifesciences and Abbott/St. Jude Medical. Dr. Leipsic is a consultant to Circle CVI and Edwards Lifesciences; and provides institutional core laboratory services to Edwards Lifesciences, Abbott, Medtronic, and Neovasc. Dr. Andreas is a proctor for Edwards and Abbott; and is an Advisory Board member for Medtronic. Dr. Guerrero has received research grant support from Abbott Vascular and Edwards Lifesciences. Dr. Castriota is a proctor for Medtronic and Boston Scientific. Dr. Kodali has received research grants from Edwards Lifesciences, Medtronic, and Boston Scientific; has received grants and personal fees from Abbott Vascular and JenaValve; has received personal fees from Meril Lifesciences; has received personal fees from and holds equity in Admedus; and holds equity in Supira, Microinterventional Devices, Dura Biotech, and Thubrikar Aortic Valve. Dr. Conradi is a consultant to Edwards Lifesciences, Medtronic, Boston Scientific, Abbott, Neovasc, and JenaValve. Dr. Nazif has received consulting fees or honoraria from Edwards Lifesciences, Medtronic, Boston Scientific, Biotrace, and Baylis Medical; and has received consulting fees from and holds equity in Venus Medtech. Dr. Pilgrim has received research grants from Boston Scientific, Edwards Lifesciences, and Biotronik; and has received speaker fees from Boston Scientific and Biotronik. Dr. Babaliaros is a consultant to Edwards Lifesciences; and holds equity in Transmural Systems. Dr. Van Mieghem has received institutional research grants and consulting fees from Abbott, Boston Scientific, Medtronic, Daiichi-Sankyo, and PulseCath; and has received institutional research grant support from Edwards Lifesciences. Dr. Latib has received institutional research or grant support from Abbott, Boston Scientific, Medtronic, and Edwards Lifesciences; and has received personal consulting honoraria from Abbott, Edwards Lifesciences, and Medtronic. Dr. Hildick-Smith is a proctor and adviser to Boston Scientific, Medtronic, and Edwards Lifesciences. 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.)

Catheter-based interventions to improve mitral valve function are dependent on anatomic and functional information provided by noninvasive imaging to plan, perform, and evaluate each intervention. In this review we highlight the importance of imaging guidance for catheter-based interventions on prosthetic mitral valves, surgical rings, and native valve annular calcification. Both repair and replacement procedures are discussed. We review the general features common to this collection of procedures and discuss specific imaging issues and concerns for each procedure. Figures and intraprocedural videos emphasize central messages using case examples., Competing Interests: Author Disclosures Dr. Little has received institutional research support from Medtronic, Abbott, Boston Scientific, 4C, and 4Tech. Dr. Bapat has been a consultant for Edwards, Medtronic, Boston Scientific, 4C, and 4Tech. Dr. Blanke has been a consultant for Tendyne/Abbott Vascular, Edwards Lifesciences, Neovasc, Circle Cardiovascular Imaging; and performed CT Core Lab services (University of British Columbia) for Tendyne/Abbott Vascular, Edwards Lifesciences, Medtronic, and Neovasc without direct compensation. Dr. Guerrero has received grant support from Edwards. Dr. Rajagopal has been a proctor for Boston Scientific; medical advisor to Medtronic and Abbott Vascular; and founder and CEO of Opus Medical Therapies, LLC. Dr. Siegel has reported that he has 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.)

Objectives: The aim of this study was to demonstrate the safety and functionality of the Alterra Adaptive Prestent and SAPIEN 3 transcatheter heart valve (THV) in patients with dysfunctional, dilated right ventricular outflow tract (RVOT) greater or equal to moderate pulmonary regurgitation (PR)., Background: Significant variations in the size and morphology of the RVOT affect the placement of transcatheter pulmonary valves. The Alterra Prestent internally reduces and reconfigures the RVOT, providing a stable landing zone for the 29-mm SAPIEN 3 THV., Methods: Eligible patients had moderate or greater PR, weighed >20 kg, and had RVOT diameter 27 to 38 mm and length >35 mm. The primary endpoint was device success, a 5-item composite: 1 Alterra Prestent deployed in the desired location, 1 SAPIEN 3 THV implanted in the desired location within the Prestent, right ventricular-to-pulmonary artery peak-to-peak gradient <35 mm Hg after THV implantation, less than moderate PR at discharge, and no explantation 24 h post-implantation. The secondary composite endpoint was freedom from THV dysfunction (RVOT/pulmonary valve (PV) reintervention, greater or equal to moderate total PR, mean RVOT/PV gradient ≥ 35 mm Hg at 30 days and 6 months. Descriptive statistics are reported., Results: Enrolled patients (N = 15) had a median age and weight of 20 years and 61.7 kg, respectively; 93.3% were in New York Heart Association functional class I or II. Device success was 100%. No staged procedures were necessary. No THV dysfunction was reported to 6 months. No serious safety signals were reported., Conclusions: This early feasibility study demonstrated the safety and functionality of the Alterra Adaptive Prestent in patients with congenital RVOT dysfunction and moderate or greater PR. Durability and long-term outcome data are needed., Competing Interests: Author Relationship With Industry Edwards Lifesciences sponsored this study. Dr. Shahanavaz is a consultant for Medtronic; and is a proctor for Edwards Lifesciences. Dr. Balzer is a consultant and proctor for Medtronic and Edwards Lifesciences. Dr. Babaliaros is a consultant for Edwards Lifesciences; and has equity in TransMural Systems. Dr. Dimas is a consultant for Medtronic and Abbott Laboratories/St. Jude Medical. Dr. Reddy is a consultant for B. Braun Interventional Systems. Dr. Leipsic is a core laboratory consultant for Edwards Lifesciences, Medtronic, and Abbott Laboratories; and is a consultant for Circle CVI. Dr. Blanke is a consultant for Edwards Lifesciences. Dr. Gorelick is an employee of Edwards Lifesciences. Dr. Zahn is a proctor and 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., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study aims to establish a computed tomography (CT)-based scoring system for grading mitral annular calcification (MAC) severity and potentially aid in predicting valve embolization during transcatheter mitral valve (MV) replacement using balloon-expandable aortic transcatheter heart valves., Background: Transcatheter MV replacement is emerging as an alternative treatment for patients with severe MAC who are not surgical candidates. Although cardiac CT is the imaging modality of choice in the evaluation of candidates for valve-in-MAC (ViMAC), a standardized grading system to quantify MAC severity has not been established., Methods: We performed a multicenter retrospective review of cardiac CT and clinical outcomes of patients undergoing ViMAC. A CT-based MAC score was created using the following features: average calcium thickness (mm), degrees of annulus circumference involved, calcification at one or both fibrous trigones, and calcification of one or both leaflets. Features were assigned points according to severity (total maximum score = 10) and severity grade was assigned based on total points (mild ≤3, moderate 4 to 6, and severe ≥7 points). The association between MAC score and device migration/embolization was evaluated., Results: Of 117 patients in the TMVR in MAC registry, 87 had baseline cardiac CT of adequate quality. Of these, 15 were treated with transatrial access and were not included. The total cohort included 72 (trans-septal = 37, transapical = 35). Mean patient age was 74 ± 12 years, 66.7% were female, and the mean Society of Thoracic Surgery risk score was 15.4 ± 10.5%. The mean MAC score was 7.7 ± 1.4. Embolization/migration rates were lower in higher scores: Patients with a MAC score of 7 had valve embolization/migration rate of 12.5%, MAC score ≥8 had a rate of 8.7%, and a MAC score of ≥9 had zero (p = 0.023). Patients with a MAC score of ≤6 had 60% embolization/migration rate versus 9.7% in patients with a MAC score ≥7 (p < 0.001). In multivariable analysis, a MAC score ≤6 was in independent predictor of valve embolization/migration (odds ratio [OR]: 5.86 [95% CI: 1.00 to 34.26]; p = 0.049)., Conclusions: This cardiac CT-based score provides a systematic method to grade MAC severity which may assist in predicting valve embolization/migration during trans-septal or transapical ViMAC procedures., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Although aortic valve replacement is associated with a major benefit in high-gradient (HG) severe aortic stenosis (AS), the results in low-gradient (LG, mean gradient <40 mm Hg) AS are conflicting. LG severe AS may be subdivided in classical low-flow (left ventricular ejection fraction <50%) and LG (CLF-LG); paradoxical low-flow (left ventricular ejection fraction ≥50% but stroke volume index <35 mL/m 2 ) and LG; and normal-flow (left ventricular ejection fraction ≥50% and stroke volume index ≥35 mL/m 2 ) and LG. The primary objective is to determine in the PARTNER 2 trial (The Placement of Aortic Transcatheter Valves) and registry the outcomes after aortic valve replacement of the 4 flow-gradient groups., Methods: A total of 3511 patients from the PARTNER 2 Cohort A randomized trial (n=1910) and SAPIEN 3 registry (n=1601) were included. The flow-gradient pattern was determined at baseline transthoracic echocardiography and classified as follows: (1) HG; (2) CLF-LG; (3) paradoxical low-flow-LG; and (4) normal-flow-LG. The primary end point for this analysis was the composite of (1) death; (2) rehospitalization for heart failure symptoms and valve prosthesis complication; or (3) stroke., Results: The distribution was HG, 2229 patients (63.5%); CLF-LG, 689 patients (19.6%); paradoxical low-flow-LG, 247 patients (7.0%); and normal-flow-LG, 346 patients (9.9%). The 2-year rate of primary end point was higher in CLF-LG (38.8%) versus HG: 31.8% ( P =0.002) and normal-flow-LG: 32.1% ( P =0.05) but was not statistically different from paradoxical low-flow-LG: 33.6% ( P =0.18). There was no significant difference in the 2-year rates of clinical events between transcatheter aortic valve replacement versus surgical aortic valve replacement in the whole cohort and within each flow-gradient group., Conclusions: The LG AS pattern was highly prevalent (36.5%) in the PARTNER 2 trial and registry. CLF-LG was the most common pattern of LG AS and was associated with higher rates of death, rehospitalization, or stroke at 2 years compared with the HG group. Clinical outcomes were as good in the LG AS groups with preserved left ventricular ejection fraction compared with the HG group.

Background: This study aimed to compare echocardiographic findings in low-risk patients with severe aortic stenosis after surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR)., Methods: The PARTNER 3 trial (Placement of Aortic Transcatheter Valves) randomized 1000 patients with severe aortic stenosis and low surgical risk to undergo either transfemoral TAVR with the balloon-expandable SAPIEN 3 valve or SAVR. Transthoracic echocardiograms obtained at baseline and at 30 days and 1 year after the procedure were analyzed by a consortium of 2 echocardiography core laboratories., Results: The percentage of moderate or severe aortic regurgitation (AR) was low and not statistically different between the TAVR and SAVR groups at 30 days (0.8% versus 0.2%; P =0.38). Mild AR was more frequent after TAVR than SAVR at 30 days (28.8% versus 4.2%; P <0.001). At 1 year, mean transvalvular gradient (13.7±5.6 versus 11.6±5.0 mm Hg; P =0.12) and aortic valve area (1.72±0.37 versus 1.76±0.42 cm 2 ; P =0.12) were similar in TAVR and SAVR. The percentage of severe prosthesis-patient mismatch at 30 days was low and similar between TAVR and SAVR (4.6 versus 6.3%; P =0.30). Valvulo-arterial impedance (Z va ), which reflects total left ventricular hemodynamic burden, was lower with TAVR than SAVR at 1 year (3.7±0.8 versus 3.9±0.9 mm Hg/mL/m 2 ; P <0.001). Tricuspid annulus plane systolic excursion decreased and the percentage of moderate or severe tricuspid regurgitation increased from baseline to 1 year in SAVR but remained unchanged in TAVR. Irrespective of treatment arm, high Z va and low tricuspid annulus plane systolic excursion, but not moderate to severe AR or severe prosthesis-patient mismatch, were associated with increased risk of the composite end point of mortality, stroke, and rehospitalization at 1 year., Conclusions: In patients with severe aortic stenosis and low surgical risk, TAVR with the SAPIEN 3 valve was associated with similar percentage of moderate or severe AR compared with SAVR but higher percentage of mild AR. Transprosthetic gradients, valve areas, percentage of severe prosthesis-patient mismatch, and left ventricular mass regression were similar in TAVR and SAVR. SAVR was associated with significant deterioration of right ventricular systolic function and greater tricuspid regurgitation, which persisted at 1 year. High Z va and low tricuspid annulus plane systolic excursion were associated with worse outcome at 1 year whereas AR and severe prosthesis-patient mismatch were not. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02675114.

Objectives: The aim of this study was to examine the effect of different transcatheter heart valves (THVs) on valve leaflet displacement when deployed within bioprosthetic surgical valves and, thereby, risk for coronary obstruction., Background: Coronary obstruction is a potentially devastating complication during valve-in-valve (ViV) transcatheter aortic valve replacement. Strategies such as provisional stenting and intentional bioprosthetic valve leaflet laceration have been developed to mitigate this risk. Alternatively, the use of a THV that retracts the bioprosthetic leaflet away from the coronary ostium may prevent coronary obstruction., Methods: A 25-mm J-Valve, a 26-mm Evolut Pro, and a 23-mm JenaValve were implanted into both a 25-mm Trifecta surgical valve and a 25-mm Mitroflow surgical valve. A 23-mm and a 26-mm SAPIEN 3 were deployed into the Trifecta and Mitroflow, respectively. Displacement of the surgical valve leaflets (retraction vs. expansion) was measured with implantation of each THV by measuring displacement angle and maximal displacement distance., Results: Within both the Trifecta and Mitroflow valves, implantation of the J-Valve and JenaValve resulted in retraction of the surgical valve leaflets, and placement of the Evolut Pro and SAPIEN 3 resulted in tubular expansion of the surgical valve leaflets. There were significant differences in displacement angles and distances between both the J-Valve and JenaValve and the SAPIEN 3 and Evolut Pro (p < 0.0001)., Conclusions: ViV implantation with new-generation THVs that directly interact with bioprosthetic valve leaflets results in surgical valve leaflet retraction. This might mitigate the risk for coronary obstruction in selected cases of ViV transcatheter aortic valve replacement and also facilitate coronary reaccess after ViV TAVR., (Copyright © 2020 American College of Cardiology Foundation. All rights reserved.)

Background: Treatment of mitral regurgitation (MR) in the setting of severe mitral annular calcification (MAC) is challenging due to the high risk for fatal atrioventricular groove disruption and significant paravalvular leak., Objectives: The objective of this study was to evaluate the potential for transcatheter mitral valve replacement in patients with severe MAC using an anatomically designed mitral prosthesis., Methods: Nine patients (77 ± 6 years of age; 5 men) were treated with the valve, using transapical delivery performed under general anesthesia and with guidance from transesophageal echocardiography and fluoroscopy., Results: Device implantation was successful with relief of MR in all 9 patients. There were no procedural deaths. In 1 patient, left ventricular outflow tract obstruction occurred due to malrotation of the prosthesis, and successful alcohol septal ablation was performed. During a median follow-up of 12 months (range 1 to 28 months), there was 1 cardiac death, 1 noncardiac death, no other mortality, and no prosthetic dysfunction, and MR remained absent in all treated patients. Rehospitalization for heart failure occurred in 2 patients who did not die subsequently. Clinical improvement with mild or no symptoms occurred in all patients alive at the end of follow-up., Conclusions: Transcatheter mitral valve replacement in severe mitral annular calcification with a dedicated prosthesis is feasible and can result in MR relief with symptom improvement. Further evaluation of this approach for these high-risk patients is warranted., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: To evaluate the long-term (≥2 years) outcomes following transcatheter tricuspid valve repair (TTVr) with the FORMA Transcatheter Tricuspid Valve Repair System (Edwards Lifesciences, Irvine, California)., Background: Scarce data exist on long-term outcomes following TTVr., Methods: This multicenter experience included patients with severe tricuspid regurgitation (TR) who underwent TTVr with the FORMA system at 4 centers under a compassionate clinical use program. Data were collected at baseline, 30 days, and 1 year, and yearly thereafter., Results: Nineteen patients (76 ± 9 years of age, 74% women, mean EuroSCORE II [European System for Cardiac Operative Risk Evaluation] 9.2 ± 5.6%) with functional TR were included. Procedural success was achieved in 17 (89%) patients and there were no cases of 30-day mortality. At a median follow-up of 32 (interquartile range: 24 to 36) months, 4 (24%) patients had died (3 from terminal heart failure, 1 from sepsis) and 3 (18%) patients required rehospitalization for heart failure. There was 1 device-related thrombosis and 1 pulmonary embolism, both in the setting of subtherapeutic oral anticoagulation. Less than severe TR was observed at echocardiography in 67% of patients at the 2- to 3-year follow-up. Among 15 successfully implanted patients with at least 24-month follow-up, significant improvements in New York Heart Association functional class (p < 0.001), 6-min walk test (+54 m; p = 0.016) and Kansas City Cardiomyopathy Questionnaire score (+16 points; p = 0.016) were observed, compared with baseline., Conclusions: TTVr using the FORMA system showed favorable long-term safety profile in high-surgical-risk patients, with sustained functional improvement and acceptable TR reduction up to 3 years., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter mitral valve replacement (TMVR) is a rapidly evolving therapy. Follow-up of TMVR patients remains limited in duration and number treated., Objectives: The purpose of this study was to examine outcomes with expanded follow-up for the first 100 patients who underwent TMVR with the prosthesis., Methods: The Global Feasibility Study enrolled symptomatic patients with either primary or secondary mitral regurgitation (MR) who were at high or prohibitive surgical risk. The present investigation examines the first 100 patients treated in this study. Clinical outcomes through last clinical follow-up were adjudicated independently., Results: In the cohort (mean age 75.4 ± 8.1 years; 69% men), there was a high prevalence of severe heart failure symptoms (66%), left ventricular dysfunction (mean ejection fraction 46.4 ± 9.6%), and morbidities (Society of Thoracic Surgeons Predicted Risk of Mortality, 7.8 ± 5.7%). There were no intraprocedural deaths, 1 instance of major apical bleeding, and no acute conversion to surgery or need for cardiopulmonary bypass. Technical success was 96%. The 30-day rates of mortality and stroke were 6% and 2%, respectively. The 1-year survival free of all-cause mortality was 72.4% (95% confidence interval: 62.1% to 80.4%), with 84.6% of deaths due to cardiac causes. Among survivors at 1 year, 88.5% were New York Heart Association function class I/II, and improvements in 6-min walk distance (p < 0.0001) and quality-of-life measurements occurred (p = 0.011). In 73.4% of survivors, the Kansas City Cardiomyopathy Questionnaire score improved by ≥10 points., Conclusions: In this study of TMVR, which is the largest experience to date, the prosthesis was highly effective in relieving MR and improving symptoms, with an acceptable safety profile. Further study to optimize the impact on long-term survival is needed., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Severe mitral regurgitation (MR) conveys significant morbidity and mortality, and surgical repair or replacement may not be a desirable option., Objectives: The purpose of this study was to evaluate the feasibility of a percutaneous transseptal transcatheter mitral valve replacement (TMVR) system., Methods: This first-in-human study was conducted between August 2017 and August 2018. The system comprises a nitinol dock, which encircles the chordae tendineae, and a balloon-expandable transcatheter heart valve. The dock and transcatheter heart valve form an ensemble, with the native mitral valve leaflets secured in between, thereby abolishing MR. Key inclusion criteria were severe symptomatic MR and high surgical risk; exclusion criteria included left ventricular ejection fraction <30% or screening suggesting unfavorable anatomy. The primary endpoint was technical success as defined by Mitral Valve Academic Research Consortium (MVARC) criteria at completion of the index procedure. The secondary endpoint was freedom from mortality, stroke, and device dysfunction (MR grade >1, mitral gradient >6 mm Hg, left ventricular outflow tract gradient >20 mm Hg) at 30 days., Results: Ten patients with severe MR of various etiologies (4 degenerative, 4 functional, and 2 mixed) were treated. The device was successfully implanted and the primary endpoint was achieved in 9 of 10 patients (90%). By transesophageal echocardiography, total MR was reduced to ≤ trivial in all implanted patients, and mean transmitral gradient was 2.3 ± 1.4 mm Hg. A pericardial effusion occurred in 1 patient: pericardiocentesis was performed, and the device was not implanted. Median length of hospital stay was 1.5 days. At 30 days, there was no stroke, myocardial infarction, rehospitalization, left ventricular outflow tract obstruction, device migration, embolization, or conversion to mitral surgery. One patient had recurrent regurgitation due to a paravalvular leak, treated with a closure device. All other treated patients had ≤1+ MR. No patients died., Conclusions: Percutaneous transvenous transseptal TMVR is feasible and safe in patients with severe MR who are at high risk for mitral valve surgery. Further evaluation is warranted., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to describe the 1-year experience with the transcatheter FORMA system for severe tricuspid regurgitation (TR)., Background: Severe TR is associated with significant morbidity and mortality. Novel transcatheter therapies have been recently developed., Methods: Eighteen patients underwent device implantation at 3 centers in Canada and Switzerland. Baseline characteristics, procedural, 30-day, and 1-year outcomes were prospectively evaluated using multimodality imaging and hemodynamic and clinical assessments., Results: Procedural success was achieved in 16 (89%) patients. Unsuccessful procedures were because of right ventricular perforation requiring open surgery and device dislocation. At 1 year there were no deaths, significant arrhythmias, device infections, or dislocations. Thrombus was observed on 1 device at 4 months and there was 1 rehospitalization for heart failure. Among the 14 patients with successful device implantation and 1-year follow-up, 79% were in New York Heart Association functional class I/II (p < 0.001), the average 6-min walk test increased by 84 m (p = 0.03), and the Kansas City Cardiomyopathy Questionnaire heart failure score improved by 18 points (p = 0.02) compared with baseline. Echocardiography showed a reduction of TR from severe in 17 of 18 (94%) patients at baseline to moderate-severe or less in 11 of 16 patients (69%) by 30 days (p = 0.001) and 6 of 13 patients (46%) by 1 year (p = 0.01). The diameters of the tricuspid annulus and the right ventricle were reduced at 1 year (45.7 ± 4.8 mm to 42.1 ± 4.4 mm, p = 0.004; 54 ± 5.3 mm to 49.9 ± 4.3 mm, p = 0.02, respectively)., Conclusions: Implantation of the FORMA system in high-risk patients with severe TR shows feasibility with a good mid-term safety profile. At 1 year, despite variable success in reducing echocardiographic TR grade, there were significant clinical improvements and reductions in right ventricular dimensions., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Transcatheter interventions to treat mitral and tricuspid valve disease are becoming increasingly available because of the growing number of elderly patients with significant comorbidities or high operative risk. Thorough clinical and imaging evaluation in these patients is essential. The latter involves both characterization of the mechanism and severity of valvular disease as well as determining the hemodynamic consequences and extent of ventricular remodeling, which is an important predictor of future outcomes. Moreover, an assessment of the suitability and risk of complications associated with device-specific therapies is also an important component of the preprocedural evaluation in this cohort. Although echocardiography including 2-dimensional and 3-dimensional methods has an important role in the initial assessment and procedural guidance, cross-sectional imaging, including both computed tomographic imagning and cardiac magnetic resonance imaging, is increasingly being integrated into the evaluation of mitral and tricuspid valve disease. In this review, we discuss the role of cross-sectional imaging in mitral and tricuspid valve disease, primarily valvular regurgitation assessment, with an emphasis on the preprocedural evaluation and implications for transcatheter interventions., (© 2017 American Heart Association, Inc.)

Background: Symptomatic mitral regurgitation (MR) is associated with high morbidity and mortality that can be ameliorated by surgical valve repair or replacement. Despite this, many patients with MR do not undergo surgery. Transcatheter mitral valve replacement (TMVR) may be an option for selected patients with severe MR., Objectives: This study aimed to examine the effectiveness and safety of TMVR in a cohort of patients with native valve MR who were at high risk for cardiac surgery., Methods: Patients underwent transcatheter, transapical delivery of a self-expanding mitral valve prosthesis and were examined in a prospective registry for short-term and 30-day outcomes., Results: Thirty patients (age 75.6 ± 9.2 years; 25 men) with grade 3 or 4 MR underwent TMVR. The MR etiology was secondary (n = 23), primary (n = 3), or mixed pathology (n = 4). The Society of Thoracic Surgeons Predicted Risk of Mortality was 7.3 ± 5.7%. Successful device implantation was achieved in 28 patients (93.3%). There were no acute deaths, strokes, or myocardial infarctions. One patient died 13 days after TMVR from hospital-acquired pneumonia. Prosthetic leaflet thrombosis was detected in 1 patient at follow-up and resolved after increased oral anticoagulation with warfarin. At 30 days, transthoracic echocardiography showed mild (1+) central MR in 1 patient, and no residual MR in the remaining 26 patients with valves in situ. The left ventricular end-diastolic volume index decreased (90.1 ± 28.2 ml/m 2 at baseline vs. 72.1 ± 19.3 ml/m 2 at follow-up; p = 0.0012), as did the left ventricular end-systolic volume index (48.4 ± 19.7 ml/m 2 vs. 43.1 ± 16.2 ml/m 2 ; p = 0.18). Seventy-five percent of the patients reported mild or no symptoms at follow-up (New York Heart Association functional class I or II). Successful device implantation free of cardiovascular mortality, stroke, and device malfunction at 30 days was 86.6%., Conclusions: TMVR is an effective and safe therapy for selected patients with symptomatic native MR. Further evaluation of TMVR using prostheses specifically designed for the mitral valve is warranted. This intervention may help address an unmet need in patients at high risk for surgery. (Early Feasibility Study of the Tendyne Mitral Valve System [Global Feasibility Study]; NCT02321514)., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: We sought to evaluate the frequency of early hypo-attenuated leaflet thickening (HALT) of the SAPIEN 3 transcatheter aortic valve (S3)., Methods and Results: Of 249 patients who had undergone S3 implantation, we studied 156 consecutive patients (85 women, median age 82.2 ± 5.5 years) by electrocardiogram (ECG)-triggered dual-source computed tomography angiography (CTA) after a median of 5 days post-transcatheter aortic valve implantation. The prosthesis was assessed for HALT. Apart from heparin, peri-interventional antithrombotic therapy consisted of single- (aspirin 29%) or dual- (aspirin plus clopidogrel 71%) antiplatelet therapy. Hypo-attenuated leaflet thickening was found in 16 patients [10.3% (95% confidence interval (CI) 5.5-15.0%)] of the patients. None of the baseline and procedural variables were significantly associated with HALT, nor did we find a significant association with the antithrombotic regimen, either peri-interventionally or at the time of CTA. Hypo-attenuated leaflet thickening was found in 6 of 45 patients with peri-interventional single-antiplatelet therapy and in 10 of 111 patients with dual-antiplatelet therapy at the time of intervention [13.3% (95% CI 3.4-23.3%) vs. 9% (95% CI 3.7-14.3%), P = 0.42]. Hypo-attenuated leaflet thickening was not associated with clinical symptoms, but a small, albeit significant difference in mean pressure gradient at the time of CTA (11.6 ± 3.4 vs. 14.9 ± 5.3 mmHg, P = 0.026). Full anticoagulation led to almost complete resolution of HALT in 13 patients with follow-up CTA., Conclusion: Irrespective of the antiplatelet regimen, early HALT occurred in 10% of our patients undergoing transcatheter aortic S3 implantation. Early HALT is clinically inapparent and reversible by full anticoagulation., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.)

Background: Previously, through the use of computed tomography (CT), it has been proposed that D-shaped versus saddle-shaped mitral annulus (MA) segmentation is more biomechanically appropriate to determine transcatheter mitral valve implantation size and eligibility., Methods and Results: Forty-one patients with severe mitral regurgitation being considered for transcatheter mitral valve implantation who had undergone cardiac CT and 3-dimensional transesophageal echocardiography (3D-TEE) were retrospectively evaluated. A standardized segmentation protocol for the D-shaped MA was developed using Philips Q-Laboratory mitral valve quantification software. MA dimensions were compared using Spearman's rank correlation and Bland-Altman analysis. Inter- and intraobserver agreement was quantified by intraclass correlation coefficient and Bland-Altman analysis. Mean age was 77±14 years; 71% male (n=29); mitral regurgitation pathogenesis was functional in 54% (n=22) and myxomatous in 46% (n=19). Mean MA area and circumference by 3D-TEE and CT were 11.3±2.7 versus 11.4±3.0 (P=0.67) and 124.1±15.6 versus 123.9±15.5 (P=0.79), respectively, with excellent correlation between modalities (r=0.84 and r=0.86; P<0.0001) and no systematic bias (-0.20±1.8 cm(2) [-3.7 cm(2); 3.3 cm(2)], 0.37±9 mm [-18.0 mm; 17.27 mm]). Mean septal-to-lateral and inter-trigone distances by 3D-TEE and CT were 33.2±4.7 versus 32.5±4.4 (P=0.24) and 31.7±3.5 versus 32.6±3.6 (P=0.06), respectively, with good correlation (r=0.69 and r=0.71; P<0.0001) and no systematic bias (0.77±3.8 mm [-6.7 mm; 8.2 mm], -1.5±3.1 mm [-4.6 mm; 7.6 mm]). There was excellent intra- and interobserver agreement according to intraclass correlation coefficients >0.90 for all parameters., Conclusions: Similar to cardiac CT, 3D-TEE allows for D-shaped MA segmentation with no systematic difference in MA dimensions between modalities. This study supports the utilization of 3D-TEE as a complementary tool to CT assessment of the D-shaped MA to determine transcatheter mitral valve implantation size., (© 2016 American Heart Association, Inc.)

Objectives: This study evaluated the results of transcatheter aortic valve replacement (TAVR) in bicuspid aortic stenosis (AS) using a new-generation TAVR device., Background: A bicuspid AS is often considered a relative contraindication to TAVR. Although initial reports have demonstrated feasibility using early-generation devices, outcomes have not matched those seen with tricuspid AS. Paravalvular aortic regurgitation (AR) has been particularly problematic., Methods: We collected baseline characteristics, procedural data, and 30-day clinical follow-up findings from 8 centers in Europe and Canada that had performed TAVR in bicuspid AS using the SAPIEN 3 valve., Results: 51 patients underwent TAVR using the SAPIEN 3 valve. Patient mean age was 76.2 ± 9.3 years and the Society of Thoracic Surgeons predicted risk of mortality scores were 5.2 ± 3.7%. Bicuspid valve types were: type 0, 11.8%; type 1, 82.3%; and type 2, 1.9%. There were no cases of valve embolization or need for a second valve. Post-dilation was performed in 7.8%. The mean aortic gradient decreased from 49.4 ± 16.0 mm Hg to 11.2 ± 4.7 mm Hg. Post-implantation AR was none/trivial in 63% and mild in 37%. There were no cases of moderate or severe AR. At 30-day follow-up, there were 2 deaths (3.9%), 2 major vascular complications, and 12 patients (23.5%) required pacemaker implantation., Conclusions: TAVR in bicuspid AS using a new-generation device was feasible and effective with favorable valve performance and no cases of moderate or severe AR., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Transcatheter aortic valve replacement (TAVR) has become the standard of care for patients with hemodynamically severe aortic stenosis who are symptomatic but deemed too high risk for surgery. Recent reports suggest that sex differences exist in outcomes following TAVR and in the diagnostic imaging evaluation of patients being considered for TAVR. In this review, the authors explore the differences between men and women in baseline characteristics and outcomes following TAVR, as well as sex differences in the imaging findings of severe aortic stenosis (AS) including the diagnostic challenges in the hemodynamic assessment of severe AS in elderly women, differences in aortic valvular calcification and in the associated myocardial response to severe AS. Additionally, sex differences in imaging findings as they relate to post-TAVR complications including coronary obstruction, annular rupture and prosthesis-patient mismatch are also discussed., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aims of this study were to determine D-shaped mitral annulus (MA) dimensions in control subjects without significant cardiac disease and in patients with moderate to severe mitral regurgitation (MR) being considered for transcatheter mitral therapy and to determine predictors of annular size, using cardiac computed tomography., Background: The recently introduced D-shaped method of MA segmentation represents a biomechanically appropriate approach for annular sizing prior to transcatheter mitral valve implantation., Methods: Patients who had retrospectively gated cardiac computed tomography performed at our institution (2012 to 2014) and were free of significant cardiac disease were included as controls (n = 88; 56 ± 11 years of age; 47% female) and were compared with patients with moderate or severe MR due to functional mitral regurgitation (FMR) (n = 27) or mitral valve prolapse (MVP) (n = 32). MA dimensions (projected area, perimeter, intercommissural, and septal-to-lateral distance), maximal left atrial (LA) volumes, and phasic left ventricular volumes were measured., Results: MA dimensions were larger in patients with FMR or MVP compared with controls (area index 4.7 ± 0.6 cm(2)/m(2), 6.0 ± 1.3 cm(2)/m(2), and 7.3 ± 1.7 cm(2)/m(2); perimeter index 59 ± 5 mm/m(2), 67 ± 9 mm/m(2), and 75 ± 10 mm/m(2); intercommissural distance index 20.2 ± 1.9 mm/m(2), 21.2 ± 3.1 mm/m(2), and 24.7 ± 3.2 mm/m(2); septal-to-lateral distance index 14.8 ± 1.6, 18.1 ± 3.3, and 19.5 ± 3.4 mm/m(2) in controls and patients with FMR and MVP, respectively; p < 0.05 between controls and MR subgroups). Absolute MA area was 18% larger in patients with MVP than patients with FMR (13.0 ± 2.9 cm(2) vs. 11.0 ± 2.3 cm(2); p = 0.006). Although LA and left ventricular volumes were both independently associated with MA area index in controls and patients with MVP, only LA volume was associated with annular size in patients with FMR., Conclusions: Moderate to severe MR was associated with increased MA dimensions, especially among patients with MVP compared with control subjects without cardiac disease. Moreover, unlike in controls and patients with MVP, annular enlargement in FMR was more closely associated with LA dilation., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Isolated tricuspid valve surgery is associated with high morbidity and mortality, especially in patients with prior cardiac surgery. The transcatheter Forma Repair System (Edwards Lifesciences, Irvine, California) is designed to provide a surface for native leaflet coaptation to reduce tricuspid regurgitation (TR) by occupying the regurgitant orifice area., Objectives: This study sought to evaluate the feasibility and exploratory efficacy with this transcatheter repair system for the treatment of severe TR., Methods: Seven high-risk patients with severe TR and clinical signs of heart failure were declined for surgery and offered transcatheter treatment with this device. All procedures were performed within a cardiac catheterization laboratory or hybrid operating room under general anesthesia with transesophageal echocardiographic guidance. Vascular access was via the left axillary vein. Baseline characteristics, procedural and in-hospital outcomes, as well as 30-day follow-up were prospectively collected., Results: All patients had severe TR and New York Heart Association (NYHA) functional class II to IV (mean age 76 ± 13 years; mean logistic EuroSCORE 25.7 ± 17.4%), and underwent device implantation to improve tricuspid leaflet coaptation, thereby reducing TR. Device implantation was successful without procedural complications in all patients, with significant reductions in TR severity (moderate in 3 patients and mild in 4 patients). Median hospital length of stay was 4 days. At 30-day follow-up, all patients but 1 demonstrated improvements in NYHA functional status (to class II) with pronounced reductions in the presence and severity of peripheral edema. TR severity was assessed as being moderate at 30-day transthoracic echocardiography follow-up in all patients. No complications related to the device or vascular access were observed during follow-up., Conclusions: A transcatheter-based treatment option for severe TR appears safe and feasible with this repair system. Improvements in TR severity were documented in all patients, which were accompanied by improvements in peripheral edema and functional status., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: We report our 8-year experience in transcatheter aortic and mitral valve-in-valve (VinV) implantation., Background: Feasibility and good early outcomes associated with transcatheter aortic and mitral VinV implantation into failed surgical bioprostheses have been confirmed, but the mid-term and long-term outcomes of transcatheter aortic and mitral VinV is unknown., Methods: A total of 73 patients with aortic (n = 42) and mitral (n = 31) bioprosthetic valve dysfunction underwent transcatheter VinV implantation between April 2007 and December 2013. Edwards balloon-expandable transcatheter valves (Edwards Lifesciences Inc., Irvine, California) were used. Median follow-up was 2.52 years with a maximum of 8 years., Results: Seventy-two patients (mean age 79.7 ± 9.4 years, 32 women) underwent successful VinV implantation (success rate 98.6%). At 30 days, all-cause mortality was 1.4%, disabling stroke 1.4%, life-threatening bleeding 4.1%, acute kidney injury requiring hemodialysis 2.7%, and coronary artery obstruction requiring intervention 1.4%. No patient had greater than mild paravalvular leak. Estimated survival rates were 88.9%, 79.5%, 69.8%, 61.9%, and 40.5% at 1, 2, 3, 4, and 5 years, respectively. The small surgical valve size (19 and 21 mm) was an independent risk factor for reduced survival in aortic VinV patients. At 2-year follow-up, 82.8% of aortic and 100% of mitral VinV patients were in New York Heart Association functional class I or II., Conclusions: Transcatheter VinV for failed surgical bioprostheses can be performed safely with a high success rate and minimal early mortality and morbidity. Transcatheter VinV provides encouraging mid-term clinical outcomes in this high-risk elderly cohort of patients. Transcatheter VinV is an acceptable alternative therapy for failed aortic or mitral bioprostheses in selected high-risk patients., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to evaluate a strategy of intentional underexpansion of excessively oversized balloon-expandable transcatheter heart valves (THVs) in terms of clinical outcomes, valve function, and frame durability at 1 year., Background: Transcatheter aortic valve replacement requires the selection of an optimally sized THV to ensure paravalvular sealing and fixation without risking annular injury. However, some patients have "borderline" annular dimensions that require choosing between a THV that may be too small or another that may be too large., Methods: We evaluated 47 patients at risk of annular injury who underwent transcatheter aortic valve replacement (TAVR) with an oversized, but deliberately underexpanded, THV followed by post-dilation if required. Clinical evaluation, echocardiography, and cardiac computed tomography were performed pre-TAVR, post-TAVR, and at 1 year., Results: Deployment of oversized THVs with modest underfilling of the deployment balloon (<10% by volume) was not associated with significant annular injury. Paravalvular regurgitation was mild or less in 95.7% of patients, with post-dilation required in 10.7%. THV hemodynamic function was excellent and remained stable at 1 year. Computed tomography documented stent frame circularity in 87.5%. Underexpansion was greatest within the intra-annular THV inflow (stent frame area 85.8% of nominal). There was no evidence of stent frame recoil, deformation, or fracture at 1 year., Conclusions: In carefully selected patients with borderline annulus dimensions and in whom excessive oversizing of a balloon-expandable SAPIEN XT valve (Edwards Lifesciences, Inc., Irvine, California) is a concern, a strategy of deliberate underexpansion, with ad hoc post-dilation, if necessary, may reduce the risk of annular injury without compromising valve performance., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Transcatheter mitral valve implantation (TMVI) represents a promising approach to treating mitral valve regurgitation in patients at increased risk of perioperative mortality. Similar to transcatheter aortic valve replacement (TAVR), TMVI relies on pre- and periprocedural noninvasive imaging. Although these imaging modalities, namely echocardiography, computed tomography, and fluoroscopy, are well established in TAVR, TMVI has entirely different requirements. Approaches and nomenclature need to be standardized given the multiple disciplines involved. Herein we provide an overview of anatomical principles and definitions, a methodology for anatomical quantification, and perioperative guidance., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to compare the influence of the extent of multidetector computed tomography (MDCT) area oversizing on the incidence of paravalvular aortic regurgitation (PAR) between the Sapien 3 and the Sapien XT transcatheter heart valve (THV) to define a new MDCT sizing guideline suitable for the Sapien 3 platform., Background: The inverse relationship of PAR occurrence and oversizing has been demonstrated for the Sapien XT but the incidence of PAR with comparable oversizing with the Sapien 3 is not known., Methods: Sixty-one prospectively enrolled patients who underwent transcatheter aortic valve replacement with the Sapien 3 THV were compared with 92 patients who underwent transcatheter aortic valve replacement with the Sapien XT THV. Patients were categorized depending on the degree of MDCT area oversizing percentage: undersizing (below 0%), 0% to 5%, 5% to 10%, and above 10%. The primary endpoint was mild or greater PAR on transthoracic echocardiography., Results: Mild or greater PAR was present in 19.7% of patients (12 of 61) in the Sapien 3 group and in 54.3% of patients (50 of 92) in the Sapien XT group (p < 0.01). The Sapien 3 group, compared with the Sapien XT group, consistently demonstrated significantly lower rates of mild or greater PAR except for oversizing >10% (p for interaction = 0.54). Moderate or severe PAR rates were also lower in the Sapien 3 group than in the Sapien XT group (3.3% vs. 13.0%, p = 0.04). In the Sapien 3 group, a MDCT area oversizing percentage value of ≤4.17% was identified as the optimal cutoff value to discriminate patients with or without mild or greater PAR., Conclusions: Our retrospective analysis suggests that the Sapien 3 THV displays significantly lower rates of PAR than does the Sapien XT THV. A lesser degree of MDCT area oversizing may be employed for this new balloon-expandable THV., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to assess the clinical outcomes and hemodynamic performance associated with a strategy of underexpanding balloon-expandable transcatheter heart valves (THV) when excessive oversizing is a concern., Background: Transcatheter aortic valve replacement depends on the selection of an optimally sized THV. An undersized THV may lead to paravalvular regurgitation, whereas excessive oversizing may lead to annular injury., Methods: Patients (n = 47) who underwent transcatheter aortic valve replacement with an intentionally underexpanded THV (balloon-filling volume reduced ~10%) were compared with consecutive control patients who had nominal THV balloon deployment (n = 87). Pre- and post-procedural computed tomography imaging and echocardiography were performed to assess THV stent expansion and hemodynamics., Results: Underfilling resulted in THV underexpansion that was maximal at the THV inflow (85.0 ± 7.4% vs. 102.5 ± 6.2%, p < 0.001), in study versus control groups, respectively. The study group received larger THV, although annular injury was not observed. Post-dilation was required in 10.6% and 4.6% of patients of the study and control groups, respectively (p = 0.165). Echocardiographic THV area, gradient, paravalvular regurgitation, and in-hospital outcomes were similar., Conclusions: Intentionally underexpanding balloon-expandable THV by underfilling the deployment balloon did not adversely affect procedural clinical outcomes, THV gradients, or THV areas. A strategy of underexpansion, with post-dilation as necessary, might play in role in reducing the risk of annular injury and paravalvular regurgitation in selected patients., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: Oral anticoagulation in mechanical heart valve recipients remains crucial, and vitamin K antagonists (VKA) are still the gold standard. Polymorphisms of vitamin K epoxide oxidase reductase (VKORC) and cytochrome p450 (CYP2C9) were recently found to influence VKA metabolism. We retrospectively investigated the prevalence of these genotypes and associated anticoagulation-related complications in our patients., Methods: Between August 1998 and August 2008, 563 patients received mechanical heart valve replacement in our institution. Of these, 179 completed a questionnaire on anticoagulation-related complications and consented to genetic analysis. We analysed polymorphisms of VKORC (-1639 G>A; 1173 C>T) and of CYP2C9 (*2, 144 C>T; *3, 359 A>C) by PCR and restriction analysis., Results: For VKORC-1639/1173 alleles, there were 62 (35%) patients with the combination GG/CC, 91 (51%) with GA/CT, 25 (14%) with AA/TT and 1 (1%) with AA/CT. Phenprocoumon (PC) dosage was related to VKORC polymorphism (P < 0.001) with lower doses required for AA/TT patients. Overall, there were 27 severe bleedings and 11 thromboembolic events. For GG/CC, the incidence of major bleeding events and thromboembolic events was 13 and 6%, respectively, and for AA/TT, it was 27 and 12%, respectively. Variation in international normalized ratio (INR) >1.5 was associated with severe bleeding complications (P = 0.025) and GA/CT patients were predisposed to INR variations >1.5 (P = 0.028). No influence of CYP2C9 polymorphism on PC dosage and anticoagulation-related complications was found., Conclusions: VKORC polymorphism affects PC dosage and anticoagulation-related complication rates in mechanical heart valve recipients. Genotyping may help to identify patients at particular risk of anticoagulation-related complications.

Objectives: This study sought to investigate pulsatile changes of the aortic annulus and their impact on prosthesis selection by computed tomography (CT)., Background: Precise noninvasive prosthesis sizing is a prerequisite for transcatheter aortic valve replacement., Methods: A total of 110 patients with severe aortic stenosis (mean age: 82.9 ± 8 years, mean aortic valve area: 0.69 ± 0.18 cm(2)) underwent electrocardiogram-gated CT. Aortic annulus dimensions were planimetrically quantified as area-derived diameter (D(A) = 2 ×✓(CSA/π), where CSA is the cross-sectional area) and perimeter-derived diameter (D(P) = P/π, where P is the length of the perimeter) in 5% increments of the RR interval. Hypothetical prosthesis sizing was based on D(A) and D(P) (23-mm prosthesis for <22 mm; 26 mm: 22 to 25 mm; 29 mm: >25 mm) and compared between maximum and traditional cardiac CT reconstruction phases at 35% and 75% of RR. Agreement for prosthesis selection was calculated by κ statistics., Results: D(A) and D(P) were increased and eccentricity was reduced during systole, with D(A-MAX) and D(P-MAX) most often observed at 20% of RR. D(P) was consistently larger than D(A). Average net differences were 2.0 ± 0.6 mm and 1.7 ± 0.5 mm by D(A-MIN) versus D(A-MAX) and D(P-MIN) versus D(P-MAX). Agreement for prosthesis sizing was found in 93 of 110 patients (κ = 0.75) by D(A-75%) and in 80 of 110 patients (κ = 0.53) by D(A-MAX) compared with D(A-35%); and in 94 of 110 patients (κ = 0.73) by D(P-75%) and in 93 of 110 patients (κ = 0.73) by D(P-MAX) compared with D(P-35%). With sizing by D(A-75%) or D(P-75%), nominal prosthesis diameter was smaller than D(A-MAX) or D(P-MAX) in 15 and 6 patients respectively., Conclusions: Aortic annulus morphology exhibits conformational pulsatile changes throughout the cardiac cycle due to deformation and stretch. These changes affect prosthesis selection. Prosthesis selection by diastolic perimeter- or area-derived dimensions harbors the risk of undersizing., (Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: To retrospectively investigate the potential cause of contained rupture of the aortic root in balloon-expandable transcatheter aortic valve implantation (TAVI) by means of pre- and postinterventional multislice computed tomography., Methods and Results: Seventy-two patients (mean age 82±7 years, mean aortic valve area 0.69±0.19 cm(2)) underwent balloon-expandable TAVI using the EdwardsSAPIEN Transcatheter Heart Valve (23 mm, n=19; 26 mm, n=50; 29 mm, n=3). Aortic annulus dimensions were quantified by multislice computed tomography-based cross-sectional area assessment and average diameter calculation (CAAD) before and after TAVI. Post-TAVI multislice computed tomography data sets were available in 65 patients; contained aortic root rupture was diagnosed in 3 patients. Pre-TAVI CAAD was 23.1±1.8 mm; post-TAVI CAAD was 22.9±1.3 mm. Median relative change in CAAD pre- and post-TAVI was -0.5% (interquartile range, 3.6%). Relative increase of 5% to 10% was observed in 4 patients (1 with contained rupture), relative increase >10% in 2 patients, both with contained rupture. Mean relative oversizing, calculated as the relative difference in diameter between pre-TAVI CAAD and nominal diameter of the selected prosthesis, was 9.8%±7.8%. Relative oversizing was significantly higher in patients with contained rupture compared with patients without contained rupture (24.6%±5.4% versus 9.1%±6.6%; P<0.001). Relative oversizing ≥20% occurred in 6 patients (3 with contained rupture)., Conclusions: Contained rupture of the aortic root in balloon-expandable TAVI is associated with severe prosthesis oversizing. Multislice computed tomography-based assessment of aortic annulus dimension in conjunction with adapted sizing guidelines may reduce the incidence of severe oversizing.

Objective: Accurate preoperative assessment of the aortic annulus dimensions is critical in patients undergoing transcatheter aortic valve implantation (TAVI) for severe AS. Using multislice computed tomography (MSCT), we evaluated a novel approach to quantify aortic annulus dimensions using cross-sectional area (CSA) assessment and average diameter calculation compared with the commonly applied electronic caliper measurements in patients undergoing transapical implantation of the Edwards SAPIEN Transcatheter Heart Valve., Methods: Seventy-one patients underwent pre-TAVI MSCT with the following dimensions assessed at the level of the most basal attachment points of all three aortic cusps joined by a virtual ring: CSA, calculated average annulus diameter (CAAD), and minimal, maximum, sagittal and coronal diameters. Measurements were compared with post-TAVI MSCT data sets at the level of the ventricular stent ending in 24 patients. Pre-TAVI measurements were compared to those taken post-TAVI. Eligibility to balloon-expandable TAVI was evaluated based on the different measurements., Results: The Edwards SAPIEN valve (23 mm, n=8; 26 mm, n=16) was implanted 2.1±1.1 mm below the non-coronary sinus. Pre-TAVI CAAD was 23.0±1.6 mm; post-TAVI CAAD was 23.0±1.1 mm. Post-TAVI CSA was circular in 18 patients (75%) and ovoid in six (25%). Pre- and post-TAVI assessment showed strong correlation for CSA and CAAD (r=0.835, p<0.001; r=0.841, p<0.001, respectively). Minimal, maximum, coronal and sagittal dimension correlated weakly between pre- and post-TAVI measurements (r=0.435-0.632, p=0.001-0.034)., Conclusion: Pre-TAVI CSA assessment and average diameter calculation using a virtual ring method is able to predict the post-interventional configuration of the annulus after balloon-expandable TAVI. We regard this approach as the best-available method to select the appropriate prosthesis size for balloon-expandable TAVI. Specific MSCT-based sizing recommendations should be developed., (Copyright © 2010 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.)