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Background: Transcatheter aortic valve implantation (TAVI) is increasingly being used in younger patients and those with lower peri-procedural risk, meaning more patients will live long enough to experience structural valve deterioration (SVD) of the bioprosthesis, indicating repeated TAVI. Experience of repeated TAVI-transcatheter heart valve (THV) implantation into an index THV is limited. This registry aims to assess the peri-procedural and short-term safety, efficacy and durability of repeated TAVI., Methods: The ReTAVI Prospective observational registry is an investigator-initiated, multicentre, international, prospective registry of patients undergoing repeated TAVI using balloon-expandable SAPIEN prosthesis to evaluate procedural and short-term safety, efficacy and durability as well as anatomical and procedural factors associated with optimal results. The registry will enrol at least 150 patients across 60 high-volume centres. Patients must be ≥18 years old, have had procedural success with their first TAVI, have index THV device failure, intend to undergo repeated TAVI and be considered suitable candidates by their local Heart Team. All patients will undergo a 30-day and 12-month follow-up. The estimated study completion is 2025., Conclusions: The registry will collect pre-, peri-, postoperative and 12-months data on patients undergoing repeated TAVI procedures with THVs for failure of the index THV and determine VARC-3-defined efficacy and safety at 30 days and functional outcome at 12 months. The registry will expand existing data sets and identify patient characteristics/indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis., (© 2024 The Author(s). European Journal of Clinical Investigation published by John Wiley & Sons Ltd on behalf of Stichting European Society for Clinical Investigation Journal Foundation.)

Transcatheter aortic valve (TAV) thrombosis may manifest as subclinical leaflet thrombosis (SLT) and clinical valve thrombosis. SLT is relatively common (10%-20%) after transcatheter aortic valve replacement, but clinical implications are uncertain. Clinical valve thrombosis is rare (1.2%) and associated with bioprosthetic valve failure, neurologic or thromboembolic events, heart failure, and death. Treatment for TAV thrombosis has been understudied. In principle, anticoagulation may prevent TAV thrombosis. Non-vitamin K oral anticoagulants, as compared to antiplatelet therapy, are associated with reduced incidence of SLT, although at the cost of higher bleeding and all-cause mortality risk. We present an overview of existing literature for management of TAV thrombosis and propose a rational treatment algorithm. Vitamin K antagonists or non-vitamin K oral anticoagulants are the cornerstone of antithrombotic treatment. In therapy-resistant or clinically unstable patients, ultraslow, low-dose infusion of thrombolytics seems effective and safe and may be preferred over redo-transcatheter aortic valve replacement or explant surgery., Competing Interests: Funding Support and Author Disclosures Dr Cabau has received institutional research grants and consultant/speaker fees from Edwards Lifesciences and Medtronic. Dr Mehran has received institutional research payments from Abbott, Abiomed, Affluent Medical, Alleviant Medical, Amgen, AM-Pharma, Arena, AstraZeneca, AtriCure Inc, Biosensors, Biotronik, Boston Scientific, Bristol Myers Squibb, CardiaWave, CeloNova, CERC, Chiesi, Cleerly Health Inc, Concept Medical, Cytosorbents, Daiichi-Sankyo, Duke, Element Science, Essential Medical, Faraday, Idorsia Pharmaceuticals, Janssen, MedAlliance, Mediasphere, Medtelligence, Medtronic, MJH Healthcare, Novartis, OrbusNeich, Penumbra, PhaseBio, Philips, Pi-Cardia, PLx Pharma, Population Health Research Institute, Protembis, RecCor Medical Inc, RenalPro, RM Global, Sanofi, Shockwave, Vivasure, and Zoll; has received personal fees from Affluent Medical, Boehringer Ingelheim, Cardiovascular Research Foundation (CRF), Cordis, Daiichi-Sankyo Brasil, E.R. Squibb & Sons, Esperion Science/Innovative Biopharma, Europa Group/Boston Scientific, Gaffney Events, Educational Trust, Henry Ford Health Cardiology, Ionis Pharmaceuticals, Lilly and Company, MedCon International, Novartis, NovoNordisk, PeerView Institute for Medical Education, TERUMO Europe N.V., Vectura, VoxMedia, WebMD, IQVIA, Radcliffe, and TARSUS Cardiology; has received honorarium payments from JAMA Cardiology (Associate Editor), and the ACC (BOT Member, SC Member CTR Program); and has equity <1% in Elixir Medical, Stel, CntrolRad (spouse). Dr Park has received grants from Daiichi-Sankyo, ChongKunDang Pharm, and Daewoong Pharm; has received personal fees from Edwards and Medtronic; and has received grants and personal fees from Abbott Vascular. Dr Ten Berg has received institutional grant support from ZonMw and Daiichi-Sankyo. Dr de Backer received institutional research grants and consulting fees from Abbott, Boston Scientific, and Medtronic. Dr Hengstenberg has been a clinical proctor for Boston Scientific and Edwards Lifesciences; and has received payment for speaker bureaus, support for attending meetings, and advisory board participation from Daiichi-Sankyo, Inc. Dr Budde has received speakers’ fees from Bayer; has received institutional support to Erasmus MC by Bayer, Heartflow, and Siemens; and has participated in the advisory board for Bayer. Dr Dangas has received a research grant from DSI. Dr Makkar has received research grants from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific; and has received travel support from Edwards Lifesciences and Boston Scientific. Dr Van Mieghem has received grant support/research contracts from Abbott Vascular, Boston Scientific, Medtronic, Edwards Lifesciences, Daiichi-Sankyo, AstraZeneca, and PulseCath BV; and has received consulting/speaker fees from Abbot Vascular, Boston Scientific Corporation, Medtronic, Daiichi-Sankyo, PulseCath BV, JenaValve, and Amgen. Dr Adrichem has reported that he has no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: The optimal strategy of monitoring for conduction disturbances in patients undergoing transcatheter aortic valve implantation (TAVI) is uncertain. We evaluated a pre- and post-TAVI remote ambulatory cardiac monitoring (rACM) strategy for identification of conduction disturbances and to reduce unplanned pre-discharge post-TAVI permanent pacemaker implantation (PPMI)., Methods and Results: REdireCT TAVI (NCT0381820) was a prospective cohort study of patients referred for outpatient TAVI. Patients with prior PPMI were excluded. Remote ambulatory cardiac monitoring consisted of 2 weeks of continuous electrocardiogram (ECG) monitoring (Pocket-ECGTM) both before and after TAVI. Compliance to monitoring, frequency of notifications, unplanned PPMI post-TAVI, and length of hospitalization were measured. Between June 2018 and March 2020, in 192 undergoing TAVI (mean age: 81.8 years; female sex 46%; balloon-expandable valve 95.3%), compliance to rACM was 91.7% pre-TAVI (mean duration: 12.8 days), and 87.5% post-TAVI (mean duration: 12.9 days). There were 24 (12.5%) rACM notifications (13 pre-TAVI; 11 post-TAVI) resulting in 14 (7.3%) planned PPMI: seven pre-TAVI [due to sinus pauses n = 2 or atrio-ventricular block (AVB) n = 5] and seven post-TAVI [due to sinus pauses n = 1 or AVB n = 5 or ventricular tachycardia (VT) n = 1]. In addition, nine (4.7%) patients received pre-TAVI PPMI due to high-risk baseline ECG (right bundle branch block with hemi-block or prolonged PR interval). Unplanned PPMI post-TAVI during index hospitalization occurred in six (3.1%) patients due to AVB and in one patient readmitted with AVB. The median length of stay post-TAVI was 1 day., Conclusion: A strategy of routine rACM was feasible and frequently led to PPMI. Our approach of 2-week rACM both pre- and post-TAVI achieves both high patient compliance and sufficient surveillance., Clinical Trial Registration: Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT03810820., Competing Interests: Conflict of interest: none declared., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Objectives: The aim of this study was to evaluate outcomes of real-world patients with aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) with the 34 mm Evolut R (Medtronic, Minneapolis, Minnesota)., Background: Larger aortic annulus has been associated with increased incidence of paravalvular leaks (PVLs) after TAVR. However, little is known, so far, about the performance of the 34 mm Evolut R in this setting., Methods: From the multicenter, international, retrospective Horizontal Aorta in Transcatheter Self-expanding Valves (HORSE) registry, including patients who underwent TAVR for native severe AS, we selected patients treated with the 34 mm Evolut R evaluating procedural characteristics and VARC-2 defined device success. We also compared 34 mm Evolut R with other Evolut R sizes., Results: Among the 4434 patients included in the registry, 572 (13%) received the 34 mm Evolut R valve. Mean age was 80.8 ± 6.5 years and the median STS PROM score was 4 [interquartile range 2-6]. Device success was achieved in 87.4% with 7.7% of PVLs; moreover, the rate of permanent pacemaker implantation (PPMI) was 22.4%. Patients who underwent 34 mm Evolut R implantation experienced more in-hospital permanent pacemaker implantation (22.4% vs. 15%; p < 0.001). At multivariate analysis, 34 mm Evolut R did not affect device success (OR: 0.81 [0.60-1.09]; p = 0.151). Device success was consistent with other THVs sizes (87.4% vs. 89.6%; p = 0.157)., Conclusions: THV replacement in patients requiring 34 mm Evolut R has an acceptable performance. Compared to other Medtronic sizes it demonstrated to be comparable in terms of device success, despite an increased rate of pacemaker implantation., (Copyright © 2022 Elsevier B.V. All rights reserved.)

A virtual workshop was organized by the Heart Valve Collaboratory to identify areas of expert consensus, areas of disagreement, and evidence gaps related to bioprosthetic aortic valve hemodynamics. Impaired functional performance of bioprosthetic aortic valve replacement is associated with adverse patient outcomes; however, this assessment is complicated by the lack of standardization for labelling, definitions, and measurement techniques, both after surgical and transcatheter valve replacement. Echocardiography remains the standard assessment methodology because of its ease of performance, widespread availability, ability to do serial measurements over time, and correlation with outcomes. Management of a high gradient after replacement requires integration of the patient's clinical status, physical examination, and multimodality imaging in addition to shared patient decisions regarding treatment options. Future priorities that are underway include efforts to standardize prosthesis sizing and labelling for both surgical and transcatheter valves as well as trials to characterize the consequences of adverse hemodynamics., Competing Interests: Funding Support and Author Disclosures Dr Herrmann has received institutional research funding from Abbott, Boston Scientific, Edwards Lifesciences, Highlife, Medtronic, and WL Gore; has received consulting fees from Edwards Lifesciences, Medtronic, Wells Fargo, and WL Gore; and has equity in Holistick Medical and Microinterventional Devices. 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. Dr Hahn has received speaker fees from Abbott Structural and Edwards Lifesciences; has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; has served on the Scientific Advisory Board for Novartis; and has equity in Navigate. Dr Tang is a physician proctor and consultant for Medtronic; has served as a consultant and physician advisory board member for Abbott Structural Heart; has served as a consultant for NeoChord; and has served as a physician advisory board member for JenaValve. Dr Abbas has received research grants and consulting fees from Edwards Lifesciences. Dr Playford has received investigator-initiated research funding from Edwards Lifesciences, Pfizer, Novartis, Actelion, Bayer, and GlaxoSmithKline; is Chief Medical Advisor for Echo IQ; and has been a physician advisory board member for Edwards Lifesciences and AstraZeneca. Dr Ruel is a physician proctor for Medtronic (MICS CABG) and for Edwards Lifesciences (MICS AVR); has served as a steering committee member for Cryolife (PROACT Xa trial); and is a recipient of research funds from Medtronic (MIST trial). Dr Jilaihawi is a consultant to Boston Scientific, Edwards Lifesciences, and Medtronic; and has received grant/research support from Abbott Vascular, Edwards Lifesciences, and Medtronic. Dr Sathananthan is a consultant for and has received institutional research funding from Edwards Lifesciences and Medtronic; and has received speaker fees from NVT. Dr Wood is a consultant for and his institution (CCI-CIC) receives grant support from Edwards Lifesciences, Abbott Vascular, and Medtronic. Dr Bax’s institution (Department of Cardiology, LUMC, the Netherlands) has received research grants from Medtronic, Biotronik, Edwards Lifesciences, and Boston Scientific. Dr Rodes-Cabau has received institutional research grants from Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Del Nido is cofounder of Autus Valve Technologies, Inc. Dr Dweck is a consultant to Edwards Lifesciences and Medtronic; has received research funding from Edwards Lifesciences and Medtronic; and has received speaker fees from NVT. Dr Kaneko is a consultant for Edwards, Medtronic, Abbott, and 4C Medical. Dr Latib is a consultant for Medtronic, Edwards Lifesciences, Boston Scientific, and Abbott. Dr Moat is a full-time employee of Abbott Structural Heart, Inc. Dr Modine has received research grants from Edwards Lifesciences and Medtronic; and is a consultant for Abbott, Edwards Lifesciences, Medtronic, and Microport. Dr Popma is a full-time employee of Medtronic, Inc. Dr Smith has received institutional grants from Edwards Lifesciences, Medtronic, Abbott, and Cryolife; has received advisory board fees from Edwards Lifesciences; and has received speaking honoraria from Medtronic, Cryolife, Abbott, and Edwards Lifesciences. Dr Thomas is a full-time employee of Edwards Lifesciences. Dr Yoganathan is a Principal Consultant to CardioMed Device Consultants LLC in the Structural Heart Valve area; is on the Scientific Advisory Board of Foldax Inc; and has served as Educational Consultant to Boston Scientific, Edwards Lifesciences, Abbott Cardiovascular, and Livanova. Dr Mack has served as a co-principal investigator for clinical trials for Abbott and Edwards Lifesciences; and has served as study chair for a trial for Medtronic; all roles were uncompensated. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: Sutureless aortic valve replacement (SU-SAVR) has been associated with higher rates of permanent pacemaker (PPM) compared with conventionally implanted aortic bioprostheses. The purpose of this study was to determine the incidence, predictors and mid-term prognostic impact of PPM after Perceval (Livanova, London, UK) SU-SAVR in low-risk patients., Methods: A total of 400 consecutive low-risk (EuroSCORE II < 4%) patients without prior pacemaker who underwent surgical aortic valve replacement with the Perceval prosthesis from 2013 to 2019 in 2 centres were included. Baseline, clinical and electrocardiographic parameters, procedural characteristics and follow-up data were collected., Results: PPM was required in 36 (9%) patients after SU-SAVR, with a median time between the procedure and PPM implantation of 7.5 (4.5-10.5) days. Older age and prior right bundle branch block (RBBB) were associated with an increased risk of PPM (P < 0.05 for all), but only baseline RBBB was found to be an independent predictor of new PPM requirement (odds ratio: 2.60, 95% confidence interval: 1.15-5.81; P = 0.022). At a median follow-up of 3.4 (2.3-4.5) years, there were no differences between groups in mortality (PPM: 36%, no PPM: 22%, P = 0.105) or heart failure rehospitalization (PPM: 25%, no PPM: 21%, P = 0.839)., Conclusions: About 1 out of 10 low-risk patients with aortic stenosis undergoing SU-SAVR with the Perceval prosthesis required PPM implantation. Prior RBBB determined an increased risk (close to 3-fold) of PPM following the procedure. PPM was not associated with a higher risk of clinical events at 3-year follow-up., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Introduction: Since the initial experience with the CoreValve (Medtronic, Minneapolis, Minnesota), there have been continuous iterations of this valve system in order to improve procedural success and reduce periprocedural complications. The Evolut Pro, Pro+, and FX are the latest generations of this transcatheter heart valve (THV)., Areas Covered: This review paper aims to analyze the main characteristics and clinical evidence about the Evolut Pro THV and summarize the main iterations of the newer generation Evolut FX valve system., Expert Opinion: The Evolut Pro system has been associated with good clinical outcomes and excellent valve hemodynamic performance including reduced rates of paravalvular leaks. Technical enhancements to improve valve positioning, orientation, and vascular access have been implemented in the newer generation Evolut FX system.

Background: Transcatheter aortic valve replacement (TAVR) is a worldwide adopted procedure with rapidly evolving practices. Regional and temporal variations are expected to be found., Objective: To compare TAVR practice in Latin America with that around the world and to assess its changes in Latin America from 2015 to 2020., Methods: A survey was applied to global TAVR centers between March and September 2015, and again to Latin-American centers between July 2019 and January 2020. The survey consisted of questions addressing: i) center's general information; ii) pre-TAVR evaluation; iii) procedural techniques; iv) post-TAVR management; v) follow-up. Answers from the 2015 survey of Latin-American centers (LATAM15) were compared with those of other centers around the world (WORLD15) and with the 2020 updated Latin-American survey (LATAM20). A 5% level of significance was adopted for statistical analysis., Results: 250 centers participated in the 2015 survey (LATAM15=29; WORLD15=221) and 46 in the LATAM20. Combined centers experience accounted for 73 707 procedures, with WORLD15 centers performing, on average, 6- and 3-times more procedures than LATAM15 and LATAM20 centers, respectively. LATAM centers performed less minimalistic TAVR than WORLD15 centers, but there was a significant increase in less invasive procedures after 5 years in Latin-American centers. For postprocedural care, a lower period of telemetry and maintenance of temporary pacing wire, along with less utilization of dual antiplatelet therapy was observed in LATAM20 centers., Conclusion: Despite still having a much lower number of procedures, many aspects of TAVR practice in Latin-American centers have evolved in recent years, followingthe trend observed in developed country centers.

Background: Horizontal aorta (HA) is an anatomical feature that can pose significant technical challenges for the successful positioning of the bioprosthetic valve during transcatheter aortic valve replacement (TAVR). Physiological range of aortic angle (AA) is unknown; hence there is no cutoff AA for classifying HA. Moreover, patient characteristics predicting HA are under-investigated., Methods: This was a retrospective analysis of prospective collected data from 16 heart valve centers in Europe. The study utilized a common dataset with a priori agreed-upon definitions and variables. Eligible patients underwent TAVR between 2014 and 2020 and had multidetector computed tomographic imaging data available for determining the AA. The analysis described the distribution of AA and potential predictors of HA. Inter-center variability was also explored., Results: For 4022 patients analyzed, the mean AA ± standard deviation was 49.4° ± 9.4° (median 49°, inter-quartile range [IQR] 12°, range 18-90°). There was no significant difference in mean AA between men and women (49.4° ± 9.1° vs. 49.6° ± 9.3°, respectively; p = 0.53); therefore, 49.4° was accepted as the cutoff value for HA in subsequent analyses. Covariates significantly associated with HA included age (odds ratio [OR]: 1.02, 95% confidence interval [CI]: 1.01-1.04, p < 0.001), body mass index (OR: 1.06, 95% CI: 1.05-1.08, p < 0.01), previous cardiac surgery (OR: 0.58, 95% CI: 0.45-0.75, p < 0.001), and porcelain aorta (OR: 0.66, 95% CI: 0.52-0.85, p = 0.001). Some inter-center variability was observed., Conclusions: We defined 49.4° as the mean AA, and also associated predictors of HA in a large case series of patients with severe aortic stenosis candidates for TAVR., Competing Interests: Declaration of Competing Interest None., (Copyright © 2021 Elsevier B.V. All rights reserved.)

[Figure: see text].

Introduction : Over the past decade, the number of transcatheter aortic valve replacement (TAVR) procedures has increased exponentially. Despite major improvements in both device and successes, the rate of hospital readmission after TAVR remains high, with heart failure (HF) decompensation being one of the most important causes. Areas covered : This review provides an overview of the current status of HF following TAVR, including details about its incidence, clinical impact, contributing factors, and current and future treatment perspectives. Expert opinion : HF decompensation has been identified as the most common cause of rehospitalization following TAVR, and it has been associated with a negative prognosis. Multiple preexisting factors including low flow status, cardiac amyloidosis, myocardial fibrosis, multivalvular disease, pulmonary hypertension, coronary artery disease, and atrial fibrillation have been associated with an increased risk of HF events. Also, multiple post-procedural factors like the occurrence of significant paravalvular leaks, severe prosthesis-patient mismatch, and conduction disturbances have also contributed to increase this risk . Thus, reducing HF events in TAVR recipients would require a multifactorial and multidisciplinary effort including the optimization of the medical treatment and close follow-up and treatment of residual or concomitant valvular disease and conduction disturbance issues. Future studies in this challenging group of patients are warranted.

Introduction: Significant mitral regurgitation (MR) frequently coexists in patients with severe symptomatic aortic stenosis undergoing transcatheter aortic valve replacement (TAVR). These patients have worse clinical outcomes than those with non-significant MR, especially if MR persists after treatment of the aortic stenosis. The optimal treatment approach for this challenging high-risk population is not well defined., Areas Covered: This review aims to present the current literature on concomitant significant MR in the TAVR population, and to provide a comprehensive algorithmic approach for clinical decision-making in this challenging cohort of patients., Expert Opinion: Concomitant mitral and aortic valve disease is a complex clinical entity. An exhaustive and comprehensive assessment of patient's clinical characteristics and mitral valve anatomy and function is required in order to assess the surgical risk, predict the MR response after AVR and evaluate the feasibility of percutaneous MV treatment if necessary. Further developments in transcatheter techniques will expand the indications for double valve treatment in operable and inoperable patients with concomitant significant MR and aortic stenosis.

Background There is a paucity of outcome data on patients who are morbidly obese (MO) undergoing transcatheter aortic valve replacement. We aimed to determine their periprocedural and midterm outcomes and investigate the impact of obesity phenotype. Methods and Results Consecutive patients who are MO (body mass index, ≥40 kg/m 2 , or ≥35 kg/m 2 with obesity-related comorbidities; n=910) with severe aortic stenosis who underwent transcatheter aortic valve replacement in 18 tertiary hospitals were compared with a nonobese cohort (body mass index, 18.5-29.9 kg/m 2 , n=2264). Propensity-score matching resulted in 770 pairs. Pre-transcatheter aortic valve replacement computed tomography scans were centrally analyzed to assess adipose tissue distribution; epicardial, abdominal visceral and subcutaneous fat. Major vascular complications were more common (6.6% versus 4.3%; P =0.043) and device success was less frequent (84.4% versus 88.1%; P =0.038) in the MO group. Freedom from all-cause and cardiovascular mortality were similar at 2 years (79.4 versus 80.6%, P =0.731; and 88.7 versus 87.4%, P =0.699; MO and nonobese, respectively). Multivariable analysis identified baseline glomerular filtration rate and nontransfemoral access as independent predictors of 2-year mortality in the MO group. An adverse MO phenotype with an abdominal visceral adipose tissue:subcutaneous adipose tissue ratio ≥1 (VAT:SAT) was associated with increased 2-year all-cause (hazard ratio [HR], 3.06; 95% CI, 1.20-7.77; P =0.019) and cardiovascular (hazard ratio, 4.11; 95% CI, 1.06-15.90; P =0.041) mortality, and readmissions (HR, 1.81; 95% CI, 1.07-3.07; P =0.027). After multivariable analysis, a (VAT:SAT) ratio ≥1 remained a strong predictor of 2-year mortality (hazard ratio, 2.78; P =0.035). Conclusions Transcatheter aortic valve replacement in patients who are MO has similar short- and midterm outcomes to nonobese patients, despite higher major vascular complications and lower device success. An abdominal VAT:SAT ratio ≥1 identifies an obesity phenotype at higher risk of adverse clinical outcomes.

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., Competing Interests: Funding Support and author Disclosures P.G. has received consultant fees from Abbott Vascular, Abiomed, Boston Scientific, Cardinal Health, Cardiovascular System Inc., Edwards Lifesciences, Medtronic, Opsens, Siemens, SoundBite Medical Solutions, Sig.Num, Saranas, Teleflex, Tryton Medical, and has equity in Pi-Cardia, Sig.Num, SoundBite Medical Solutions, Saranas, and Puzzle Medical. N.P. has received consultant fees from Medtronic, Peijia, and Microport. M.C.A.’s institution receives research funding from Edwards Lifesciences and Abbott. T.N. discloses consulting fees or honoraria from Edwards LifeSciences, Medtronic, Boston Scientific, and Biotrace Medical and consulting fees and equity from Keystone Heart. R.T.H. reports speaker fees from Boston Scientific Corporation and Baylis Medical; consulting for Abbott Structural, Edwards Lifesciences, Medtronic, Navigate, Philips Healthcare and Siemens Healthcare; non-financial support from 3mensio; and is the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. P.P. received research grants from Edwards Lifesciences and Medtronic for echo corelab analyses in TAVR. J.B. reports personal fees from Abbott Vascular and Boehringer Ingelheim, and grants from Edwards, Boston Scientific, General Electric, Biotronik, and Medtronic, all outside the submitted work. J.L. reports personal fees from Circle CVI, GE Healthcare, Philips and HeartFlow, as well as grants to his institution for core lab work from Medtronic, Edwards, Abbott, and GE Healthcare. E.H.B. reports grants to his institution from Edwards Lifesciences. A.L. reports grants from Novartis and Edwards Lifesciences, personal fees from Medtronic, Abbott, Edwards, Boston Scientific, AstraZeneca, Novartis, Pfizer, Abiomed, Bayer, Boehringer, and stock options from Picardia, Transverse Medical, and Claret Medical. M.M. reports grants from Abbott, Medtronic, and Edwards. R.M. reports grants from Abbott and Edwards Lifesciences, and personal fees from Cordis and Medtronic. R.M. reports grants, personal fees, and other from Abbott Laboratories, grants from AstraZeneca, Bayer, and Beth Israel Deaconess, grants and other from Bristol-Myers Squibb, grants from CERC, Chiesi, Concept Medical, CSL Behring, DSI, Medtronic, Novartis Pharmaceuticals, and OrbusNeich, grants and other from Abiomed, other from the Medicines Company, personal fees from Boston Scientific, personal fees from Janssen Scientific Affairs, Medscape/WebMD, Roivant Services, Sanofi, Siemens Medical Solutions, and non-financial support and other from Idorsia Pharmaceuticals, non-financial support and other from Regeneron Pharmaceuticals, other from Spectranetics/Philips/Volcano Corp, personal fees from Medtelligence (Janssen Scientific Affairs), other from Watermark Research Partners, other from Claret Medical, other from Elixir Medical, personal fees from ACC, personal fees from AMA, grants from Applied Therapeutics, other from Merck, outside the submitted work. J.P.P. reports grants from Medtronic, grants and personal fees from Edwards, grants from Boston Scientific, grants from Abbott, outside the submitted work. M.R. reports consulting for Medtronic, with fees to his institution. J.R.-C. has received institutional research grants from Edwards Lifesciences, Medtronic and Boston Scientific. Nicolas Van Mieghem has received research grants from Abbott, Boston Scientific, Edwards, Medtronic and Essential Medical/Teleflex. He received advisory fees from Abbott, Boston Scientific, Ancora, Medtronic and Essential Medical/Teleflex. J.G.W. has received consulting fees from Edwards Lifesciences. D.J.C. reports institutional research grants and personal fees from Edwards Lifesciences, grants and personal fees from Medtronic, grants and personal fees from Boston Scientific, grants and personal fees from Abbott, outside the submitted work. M.B.L. reports institutional research grants from Edwards Lifesciences, Medtronic, Boston Scientific and Abbott, and advisory board/consulting fees from Medtronic, Boston Scientific, Abbott, Gore Medical and Meril Lifescience, all outside the submitted work., (Copyright © 2021. Published by Elsevier Inc.)

Introduction : Transcatheter aortic valve replacement (TAVR) has recently expanded toward the treatment of younger patients with lower surgical risk and longer life expectancy. Thus, transcatheter heart valve (THV) durability has become a central issue, and an important increase in the number of TAVR-in-TAVR is expected in the coming years. Areas covered : Overview of the current status of TAVR-in-TAVR for the treatment of THV dysfunction, focusing on safety and efficacy of repeat TAVR procedures. Expert opinion : An accurate analysis of the pre-procedure cardiac computed tomography, incorporating new parameters such as the position of the top of the first THV in relation to the sinotubular-junction, will be necessary to assess the risk of coronary occlusion. Subsequent coronary angiography will be necessary in a proportion of TAVR-in-TAVR patients, but coronary access may be very difficult or even impossible in some of them. Therefore, the choice between TAVR and SAVR in young low-risk patients should incorporate the potential need for treating coronary events at mid- to long-term follow-up. Likewise, the choice of the valve type and the implantation position at the time of the first TAVR procedure should take into account the possibility of TAVR-in-TAVR in the future. Abbreviations ACS: acute coronary syndrome; CO: coronary obstruction; EOA: effective orifice area; SAVR: surgical aortic valve replacement; SVD: structural valve degenerationTAVR: transcatheter aortic valve replacement; THV: transcatheter heart valve.

Background: There has been an exponential increase in the demand for transcatheter aortic valve replacement (TAVR). Our goal was to examine trends in TAVR capacity and wait-times across Canada., Methods: All TAVR cases were identified from April 1, 2014, to March 31, 2017. Wait-time was defined as the duration in days from the initial referral to the TAVR procedure. TAVR capacity was defined as the number of TAVR procedures per million population/province/fiscal year. We performed multivariable multilevel Cox proportional hazards modelling of the time to TAVR as the dependant variable and the effect of provinces as random effects. We quantified the variation in wait-times among provinces using the median hazard ratio., Results: We identified a total of 4906 TAVR procedures across 9 provinces. Despite a year over year increase in overall capacity, there was a greater than 3-fold difference in capacity between provinces. Crude median wait-times increased over time in all provinces, with marked variation from 71.5 days in Newfoundland to 190.5 and 203 days in Manitoba and Alberta, respectively. This suggests increasing demand outpaced the growth in capacity. We found a median hazard ratio of 1.62, indicating that in half of the possible pairwise comparisons, the time to TAVR for identical patients was at least 62% longer between different provinces., Conclusion: We found substantial geographic inequity in TAVR access. This calls for policy makers, clinicians, and administrators across Canada to address this inequity through revaluation of provincial funding mechanisms, as well as implementation of efficient care pathways., (Copyright © 2019 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

This study sought to determine, in patients with new-onset persistent left bundle branch block (NOP-LBBB) after transcatheter aortic valve implantation (TAVI), the incidence and factors associated with (i) LBBB recovery and (ii) permanent pacemaker implantation (PPI) at 1-year follow-up. This was a multicenter study including 153 patients (mean age: 81 ± 5 years, 56% of women) with NOP-LBBB post-TAVI (balloon-expandable valve in 112 patients). Delta PR (ΔPR) and delta QRS (ΔQRS) were defined as the difference in PR and QRS length between baseline and hospital discharge ECG, and the relative ΔPR and ΔQRS as absolute ΔPR and ΔQRS divided by baseline PR and QRS length, respectively. The patients had a clinical visit and 12-lead ECG at 1-year follow-up. LBBB recovery was observed in 50 patients (33%), and 14 patients (9%) had advanced conduction disturbances requiring PPI during the follow-up period. No clinical or ECG variables were associated with LBBB recovery, including prosthesis type (self- or balloon-expandable valve, p = 0.563), QRS width at baseline/discharge or absolute/relative ΔQRS (p >0.10 for all). The presence of atrial fibrillation at baseline (0.026), a longer PR interval at discharge (0.009), and a longer absolute and relative ΔPR (p = 0.002 and p = 0.004, respectively) were associated with an increased risk of PPI at 1-year follow-up. In conclusion, NOP-LBBB post-TAVI resolved in one-third of patients at 1-year follow-up, but no clinical or ECG variables were associated with LBBB recovery. Conversely, a nonsinus rhythm at baseline and a longer ΔPR were associated with an increased risk of PPI within the year after TAVI., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Scarce data exist on coronary events following transcatheter aortic valve replacement (TAVR), and no study has determined the factors associated with poorer outcomes in this setting. This study sought to determine the clinical characteristics, outcomes, and prognostic factors of acute coronary syndrome (ACS) events following TAVR., Methods: Multicenter cohort study including a total of 270 patients presenting an ACS after a median time of 12 (interquartile range, 5-17) months post-TAVR. Post-ACS death, myocardial infarction, stroke, and overall major adverse cardiovascular or cerebrovascular events were recorded., Results: The ACS clinical presentation consisted of non-ST-segment-elevation myocardial infarction (STEMI) type 2 (31.9%), non-STEMI type 1 (31.5%), unstable angina (28.5%), and STEMI (8.1%). An invasive strategy was used in 163 patients (60.4%), and a percutaneous coronary intervention was performed in 97 patients (35.9%). Coronary access issues were observed in 2.5% and 2.1% of coronary angiography and percutaneous coronary intervention procedures, respectively. The in-hospital mortality rate was 10.0%, and at a median follow-up of 17 (interquartile range, 5-32) months, the rates of death, stroke, myocardial infarction, and major adverse cardiovascular or cerebrovascular events were 43.0%, 4.1%, 15.2%, and 52.6%, respectively. By multivariable analysis, revascularization at ACS time was associated with a reduction of the risk of all-cause death (hazard ratio, 0.54 [95% CI, 0.36-0.81] P =0.003), whereas STEMI increased the risk of all-cause death (hazard ratio, 2.06 [95% CI, 1.05-4.03] P =0.036) and major adverse cardiovascular or cerebrovascular events (hazard ratio, 1.97 [95% CI, 1.08-3.57] P =0.026)., Conclusions: ACS events in TAVR recipients exhibited specific characteristics (ACS presentation, low use of invasive procedures, coronary access issues) and were associated with a poor prognosis, with a very high in-hospital and late death rate. STEMI and the lack of coronary revascularization determined an increased risk. These results should inform future studies to improve both the prevention and management of ACS post-TAVR.

Transcatheter aortic valve implantation (TAVI) or replacement has rapidly changed the treatment of patients with severe symptomatic aortic stenosis. It is now the standard of care for patients believed to be inoperable or at high surgical risk, and a reasonable alternative to surgical aortic valve replacement for those at intermediate surgical risk. Recent clinical trial data have shown the benefits of this technology in patients at low surgical risk as well. This update of the 2012 Canadian Cardiovascular Society TAVI position statement incorporates clinical evidence to provide a practical framework for patient selection that does not rely on surgical risk scores but rather on individual patient evaluation of risk and benefit from either TAVI or surgical aortic valve replacement. In addition, this statement features new wait time categories and treatment time goals for patients accepted for TAVI. Institutional requirements and recommendations for operator training and maintenance of competency have also been revised to reflect current standards. Procedural considerations such as decision-making for concomitant coronary intervention, antiplatelet therapy after intervention, and follow-up guidelines are also discussed. Finally, we suggest that all patients with aortic stenosis might benefit from evaluation by the heart team to determine the optimal individualized treatment decision., (Copyright © 2019 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Objectives: The authors aimed to determine the procedural learning curve and minimum annual institutional volumes associated with optimum clinical outcomes for transcatheter aortic valve replacement (TAVR)., Background: Transcatheter aortic valve replacement (TAVR) is a complex procedure requiring significant training and experience for successful outcome. Despite increasing use of TAVR across institutions, limited information is available for its learning curve characteristics and minimum annual volumes required to optimize clinical outcomes., Methods: The study collected data for patients at 16 centers participating in the international TAVR registry since initiation of the respective TAVR program. All cases were chronologically ordered into initial (1 to 75), early (76 to 150), intermediate (151 to 225), high (226 to 300), and very high (>300) experience operators for TAVR learning curve characterization. In addition, participating institutions were stratified by annual TAVR case volume into low-volume (<50), moderate-volume (50 to 100), and high-volume (>100) groups for comparative analysis. Procedural and 30-day clinical outcomes were collected and multivariate regression analysis performed for 30-day mortality and the early safety endpoint., Results: A total of 3,403 patients comprised the study population. On multivariate analysis, all-cause mortality was significantly higher for initial (odds ratio [OR]: 3.83; 95% confidence interval [CI]: 1.93 to 7.60), early (OR: 2.41; 95% CI: 1.51 to 5.03), and intermediate (OR: 2.53; 95% CI: 1.19 to 5.40) experience groups compared with the very high experience operators. In addition, the early safety endpoint was significantly worse for all experience groups compared with the very high experience operators. Low annual volume (<50) TAVR institutions had significantly higher all-cause 30-day mortality (OR: 2.70; 95% CI: 1.44 to 5.07) and worse early safety endpoint (OR: 1.60; 95% CI: 1.17 to 2.17) compared with the moderate- and high-volume groups. There was no difference in patient outcomes between intermediate and high annual volume groups., Conclusions: TAVR procedures display important learning curve characteristics with both greater procedural safety and a lower mortality when performed by experienced operators. In addition, TAVR performed at low annual volume (<50 procedures) institutions is associated with decreased procedural safety and higher patient mortality. These findings have important implications for operator training and patient care at centers performing TAVR., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices. The PVL Academic Research Consortium met to review evidence and make recommendations for assessment of disease severity, data collection, and updated endpoint definitions. A 5-class grading scheme to evaluate PVL was developed in concordance with VARC recommendations. Unresolved issues in the field are outlined. The current PVL Academic Research Consortium provides recommendations for assessment of disease severity, data collection, and endpoint definitions. Future research in the field is warranted.

Background: Despite rapidly increasing use of TAVR across institutions, limited data is available for the effect of procedural experience on TAVR outcomes. We investigate the relationship between institutional experience and TAVR outcomes., Methods: 1953 patients undergoing TAVR at 8 international sites were grouped into chronological quantiles (Q) to assess temporal changes on procedural and clinical outcomes and multivariate logistic regression performed to determine predictors of device success, early safety and all-cause mortality., Results: The mean age of patients was 81±7years and 991 (51%) were female. The quantiles comprised of first 62 cases for Q1, 63-133 for Q2, 134 to 242 for Q3 and 243 to 476 for Q4. Device success increased from Q1 to Q4 (78% vs 89%, p<0.001) with significant improvement in the early safety endpoint (19% vs 10%, p<0.001). All cause mortality reduced by half in Q4 compared to Q1 (8% vs 4%, p=0.01) and rates of major vascular complications, major bleeding and valve embolization decreased with increasing experience. The multivariate analysis identified TAVR in Q3 and Q4 to be independently associated with higher device success and lower risk of complications. TAVR in Q4 was independently associated with lower mortality (OR 0.36 95% CI 0.19-0.70, p=0.002)., Conclusions: Greater institutional experience with TAVR procedures improves device success and clinical outcomes. An experience of >242 cases is independently associated with lower mortality. These findings have important implications for defining minimum volume criteria for institutions and training standards for TAVR procedure., (Copyright © 2017 Elsevier B.V. All rights reserved.)

The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices. The PVL Academic Research Consortium met to review evidence and make recommendations for assessment of disease severity, data collection, and updated endpoint definitions. A 5-class grading scheme to evaluate PVL was developed in concordance with VARC recommendations. Unresolved issues in the field are outlined. The current PVL Academic Research Consortium provides recommendations for assessment of disease severity, data collection, and endpoint definitions. Future research in the field is warranted., (Copyright © 2017 American College of Cardiology Foundation and European Society of Cardiology. Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve implantation (TAVI) has been adopted worldwide as the standard treatment for severe aortic stenosis in symptomatic patients at prohibitive or high surgical risk, but there are still several areas where consensus and evidence are lacking. The purpose was to obtain a global view of current practice related to TAVI with the potential to identify the main areas of consensus and divergence between centers., Methods: An online questionnaire was distributed in centers performing TAVI including a total of 59 questions concerning pre-procedural evaluation, procedural practices and post-procedural management., Results: The survey was completed by 250 centers (with a cumulative experience of nearly 70,000 TAVI) from 38 different countries. Heart team meetings and surgical risk scores were routinely performed in most (>95%) centers, but frailty (44%) and quality of life (28%) assessments were less frequently performed. General anesthesia remained the most frequent type of anesthesia (60% of centers), and significant variability was detected in the examinations for residual aortic regurgitation assessment during the procedure and in post-procedural ECG monitoring and temporary pacemaker implementation (from none to ≥72h post-TAVI). Dual antiplatelet therapy duration post-TAVI was highly variable (1, 3, and ≥6months in 14%, 41% and 32% of centers, respectively) and lack of consensus in antithrombotic regimen was observed in patients with atrial fibrillation requiring anticoagulation therapy (anticoagulation alone, anticoagulation+aspirin, anticoagulation+clopidogrel, and triple therapy in 28%, 37%, 26% and 4% of centers, respectively)., Conclusions: The WRITTEN survey provided extensive data on current TAVI-related practice and identified important differences between centers in key aspects of pre-, intra-, and post-operative management. This highlights the urgent need for further studies and evidence-based data to guide multiple aspects of the TAVI field., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Aims: This study sought to investigate outcomes of transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 transcatheter heart valve (THV) in patients at intermediate risk for surgery. The 30-day results of the transfemoral cohort are reported., Methods and Results: The SAPIEN 3 European approval trial intermediate-risk cohort included a total of 101 patients with severe, symptomatic aortic stenosis, at intermediate risk for surgery suitable for TAVI via the transfemoral route (TF). Outcomes were adjudicated by a clinical events committee. Echocardiography, computed tomography and electrocardiography exams were analysed in core laboratories. The mean STS-PROM score and logistic EuroSCORE of the study population were 5.2±1.7 and 13.2±3.8, respectively. A completely percutaneous procedure was performed in 90.1% of patients and conscious sedation and/or local anaesthesia was utilised in 54.5%. Technical success was achieved in 98.0% of patients. At 30 days, mortality was 1.0%, with stroke in 3.0% and a new permanent pacemaker in 4.0% (4.3% of patients without pre-procedural permanent pacemaker). No patients had severe aortic regurgitation after the procedure, only one patient had moderate aortic regurgitation, and 70.8% of patients had no or trace aortic regurgitation., Conclusions: TF-TAVI using the SAPIEN 3 THV in patients at intermediate risk for surgery is associated with a very low risk of death and complications, including new pacemakers and paravalvular leaks. Although compelling, these initial results are being confirmed in larger global studies before expanding the indications for TAVI in severe aortic stenosis.

Background: This study sought to evaluate the impact of atrial fibrillation (AF) on clinical outcomes in patients undergoing transcatheter aortic valve replacement., Methods and Results: Data were evaluated in 1879 patients with baseline and discharge ECGs who underwent transcatheter aortic valve replacement in the Placement of AoRTic TraNscathetER Valve (PARTNER) trial. A total of 1262 patients manifested sinus rhythm (SR) at baseline/SR at discharge, 113 SR baseline/AF discharge, and 470 AF baseline/AF discharge. Patients who converted from SR to AF by discharge had the highest rates of all-cause mortality at 30 days (P<0.0001 across all groups; 14.2% SR/AF versus 2.6% SR/SR; adjusted hazard ratio [HR]=3.41; P=0.0002) and over 2-fold difference at 1 year (P<0.0001 across all groups; 35.7% SR/AF versus 15.8% SR/SR; adjusted HR=2.14; P<0.0001). The presence of AF on baseline or discharge ECG was a predictor of 1-year mortality (adjusted HR=2.14 for SR/AF group and HR=1.88 for AF/AF groups; P<0.0001 for both groups versus SR/SR). For patients discharged in AF, those with lower ventricular response (ie, <90 bpm) experienced less 1-year all-cause mortality (HR=0.74; P=0.04)., Conclusions: After transcatheter aortic valve replacement, the presence of AF at discharge, and particularly, the conversion to AF by discharge and higher ventricular response are associated with increased mortality. These data underscore the deleterious impact of AF, as well as the need for targeted interventions to improve clinical outcomes, in patients undergoing transcatheter aortic valve replacement., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894., (© 2016 American Heart Association, Inc.)

Background: The incidence and prognostic impact of late bleeding complications after transcatheter aortic valve replacement (TAVR) are unknown., Objectives: The aim of this study was to identify the incidence, predictors, and prognostic impact of major late bleeding complications (MLBCs) (≥30 days) after TAVR., Methods: Clinical and echocardiographic outcomes of patients who underwent TAVR within the randomized cohorts and continued access registries in the PARTNER (Placement of Aortic Transcatheter Valves) trial were analyzed after stratifying by the occurrence of MLBCs. Predictors of MLBCs and their association with 30-day to 1-year mortality were assessed., Results: Among 2,401 patients who underwent TAVR and survived to 30 days, MLBCs occurred in 142 (5.9%) at a median time of 132 days (interquartile range: 71 to 230 days) after the index procedure. Gastrointestinal complications (n = 58 [40.8%]), neurological complications (n = 22 [15.5%]), and traumatic falls (n = 11 [7.8%]) were identified as the most frequent types of MLBCs. Independent predictors of MLBCs were the presence of low hemoglobin at baseline, atrial fibrillation or flutter at baseline or 30 days, the presence of moderate or severe paravalvular leak at 30 days, and greater left ventricular mass at 30 days. MLBCs were identified as a strong independent predictor of mortality between 30 days and 1 year (adjusted hazard ratio: 3.91; 95% confidence interval: 2.67 to 5.71; p < 0.001)., Conclusions: MLBCs after TAVR were frequent and associated with increased mortality. Better individualized and risk-adjusted antithrombotic therapy after TAVR is urgently needed in this high-risk population. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894)., (Copyright © 2014 American College of Cardiology Foundation. 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. [ABSTRACT FROM AUTHOR]