Search

Transcatheter aortic valve replacement (TAVR) has become more common than surgical aortic valve replacement since 2016, with over 200,000 procedures globally each year. As patients increasingly outlive their TAVR devices, managing these cases is a growing concern. Treatment options include surgical removal of the old TAVR device (transcatheter aortic valve [TAV] explant) or implantation of a new transcatheter aortic valve (redo TAV). Redo TAV is complex because of the unique designs of TAV devices; compatibility issues; and the need for individualized planning based on factors such as implant depth, shape, and coronary artery relationships. This review serves as a comprehensive guide for redo TAV, detailing the design characteristics of TAV devices, device compatibility, standardized terminology, and a structured approach for computed tomography analysis. It aims to facilitate decision making, risk identification, and achieving optimal outcomes in redo TAV procedures., Competing Interests: Funding Support and Author Disclosures Dr Bapat has served as a consultant for Medtronic, Edwards Lifesciences, Abbott, Anteris, Meril Lifesciences, and Boston Scientific. Dr Jilaihawi has received institutional research grants and consulting fees from Abbott Vascular, Edwards Lifesciences, and Medtronic Inc; and has received institutional research grants from Boston Scientific and Pi-Cardia. Dr Rogers is a consultant for Edwards Lifesciences, Medtronic, Boston Scientific, and Transmural Systems; serves on advisory boards for Medtronic and Boston Scientific; holds an equity interest in Transmural Systems; and is a coinventor on patents, assigned to National Institutes of Health, for transcatheter electrosurgery devices. Dr Khalique is a consultant for Edwards Lifesciences, Restore Medical, Croivalve, Heartflow, and Vdyne; and holds equity in Triflo. Dr Cavalcante is a consultant for 3Mensio, 4C Medical, Abbott Structural, Anteris, Boston Scientific, Edwards Lifesciences, JenaValve, Medtronic, and Siemens Healthineers. Dr Landes has received consulting fees from Edwards Lifesciences. Dr Sathananthan has received speaker fees from Edwards Lifesciences, Medtronic, NVT Medical, and Boston Scientific; is a consultant for Edwards Lifesciences, Boston Scientific, Medtronic, and Anteris; and serves as chief medical officer for structural division of Boston Scientific. Dr Tarantini has received lecture fees from Medtronic, Edwards Lifesciences, Abbott, and Boston Scientifics. Dr Tang has received speaker honoraria and has served as a physician proctor, consultant, advisory board member, TAVR publications committee member, APOLLO trial screening committee member, and IMPACT MR steering committee member for Medtronic; has received speaker honoraria and has served as a physician proctor, consultant, advisory board member, and TRILUMINATE trial anatomic eligibility and publications committee member for Abbott Structural Heart; has served as an advisory board member for Boston Scientific and JenaValve, a consultant and physician screening committee member for Shockwave Medical, a consultant for NeoChord, Peija Medical, and Shenqi Medical Technology; and has received speaker honoraria from Siemens Healthineers. Dr Blackman is a consultant, proctor, and advisory board member for Medtronic and Abbott Vascular; and has received institutional research grants from Medtronic. Dr De Backer has received institutional research grants and consulting fees from Abbott and Boston Scientific. Dr Mack served as co–primary investigator for the PARTNER trial for Edwards Lifesciences and the COAPT trial for Abbott; and has served as study chair for the APOLLO trial for Medtronic. Dr Leon has received institutional grants for clinical research from Abbott, Boston Scientific, Edwards Lifesciences, JenaValve, and Medtronic; and has received stock options (equity) for advisory board participation in Valve Medical, Picardia, and Venus MedTech. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BAV) stenosis is technically challenging and is burdened by an increased risk of paravalvular regurgitation (PVR)., Objectives: The aim of this study was to identify the incidence, predictors, and clinical outcomes of PVR after TAVR in Sievers type 1 BAV stenosis., Methods: Consecutive patients with Sievers type 1 BAV stenosis undergoing TAVR with current-generation transcatheter heart valves (THVs) in 24 international centers were enrolled. PVR was graded as none/trace, mild, moderate, and severe according to echocardiographic criteria. The endpoint of major adverse events (MAEs), defined as a composite of all-cause death, stroke, or hospitalization for heart failure, was assessed at the last available follow-up., Results: A total of 946 patients were enrolled. PVR occurred in 423 patients (44.7%)-mild, moderate, and severe in 387 (40.9%), 32 (3.4%), and 4 (0.4%) patients, respectively. Independent predictors of moderate or severe PVR were a larger virtual raphe ring perimeter (adjusted OR: 1.07; 95% CI: 1.02-1.13), severe annular or left ventricular outflow tract calcification (adjusted OR: 5.21; 95% CI: 1.45-18.77), a self-expanding valve (adjusted OR: 9.01; 95% CI: 2.09-38.86), and intentional supra-annular THV positioning (adjusted OR: 3.31; 95% CI: 1.04-10.54). At a median follow-up of 1.3 years (Q1-Q3: 0.5-2.4 years), moderate or severe PVR was associated with an increased risk of MAEs (adjusted HR: 2.52; 95% CI: 1.24-5.09)., Conclusions: After TAVR with current-generation THVs in Sievers type 1 BAV stenosis, moderate or severe PVR occurred in about 4% of cases and was associated with an increased risk of MAEs during follow-up., Competing Interests: Funding Support and Author Disclosures Dr Aurigemma has reported speaker fees from Abbott, Medtronic, Abiomed, and Terumo. Dr Trani has been involved in advisory board meetings or received speaker fees from Medtronic, Abbott, Terumo, Daiichi-Sankyo, and Abiomed. Dr Adamo has reported speaker honoraria from Abbott Vascular and Edwards Lifesciences. Dr Burzotta has been involved in advisory board meetings or has received speaker fees from Medtronic, Abbott, Terumo, Daiichi-Sankyo, and Abiomed. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: When a balloon-expandable transcatheter heart valve (THV) is chosen to treat a failed balloon-expandable THV, there is a risk of underexpansion with a potential impact on performance., Aims: We aimed to assess the impact of pre- and post-dilatation on the expansion of balloon-expandable THVs after redo-transcatheter aortic valve implantation (TAVI)., Methods: Redo-TAVI was performed on the bench with a 23 mm SAPIEN 3 (S3) implanted within a 23 mm SAPIEN XT (SXT) or a 23 mm S3, both of which served as the "failed" THVs. Pre- and/or post-dilatation was performed using a 23 mm non-compliant TRUE balloon. Expansion of the index and redo-THVs were assessed before and after pre-/post-dilatation using microcomputed tomography (micro-CT), and THV hydrodynamic testing was conducted., Results: Without pre- or post-dilatation, the S3 was underexpanded, for all combinations, particularly in the mid-portion of the THV (18.6 mm and 19.7 mm representing 81% and 86% of the nominal diameter inside the SXT and S3, respectively). Pre- and post-dilatation had an additive effect on diameter expansion of the redo-THV, which remained constrained in most combinations. The only combination to achieve nominal expansion was the S3 in S3 when both pre- and post-dilatation were performed. The S3 remained underexpanded inside the SXT despite pre- and post-dilatation (93% in the mid-portion). Improved redo-THV expansion was accompanied by 2.7 mm (12%) overexpansion of the index THV. While all samples had acceptable hydrodynamic performance, the underexpanded samples had worse leaflet pinwheeling., Conclusions: When performing redo-TAVI with a 23 mm S3 inside a 23 mm SXT or S3, only the S3 in S3 with the use of pre- and post-dilatation reached full expansion. This underlines the importance of CT assessment of THV expansion and the role of pre-/post-dilatation.

Transcatheter aortic valve replacement (TAVR) is increasingly being performed in younger and lower surgical risk patients. Reintervention for failed transcatheter heart valves will likely increase in the future as younger patients are expected to outlive the initial bioprosthesis. While redo-TAVR has emerged as an attractive and less invasive alternative to surgical explantation (TAVR-explant) to treat transcatheter heart valve failure, it may not be feasible in all patients due to the risk of coronary obstruction and impaired coronary access. Conversely, TAVR-explant can be offered to most patients who are surgical candidates, but the reported outcomes have shown high mortality and morbidity. This review provides the latest evidence, current challenges, and future directions on redo-TAVR and TAVR-explant for transcatheter heart valve failure, to guide aortic valve reintervention and facilitate patients' lifetime management of aortic stenosis., Competing Interests: Disclosures V.N. Bapat has served as a consultant for Medtronic, Edwards Lifesciences, 4C Medical, and Boston Scientific. J. Sathananthan has received speaker fees from Edwards Lifesciences, Medtronic, NVT Medical, and Boston Scientific and is a consultant for Edwards Lifesciences, Boston Scientific, Medtronic, and Anteris. Dr Landes has received consulting fees from Edwards Lifesciences. Dr De Backer has received institutional research grants and consulting fees from Abbott and Boston Scientific. Dr Tarantini has received lecture fees from Edwards Lifesciences, Medtronic, Abbott, Boston Scientifics, and Abiomed. Dr Grubb is a physician proctor for Medtronic and Boston Scientific and has severed as a consultant for Medtronic, Edwards Lifesciences, Boston Scientific, Ancora, Abbott, and 4C Medical. Dr Kaneko is a speaker for Edwards Life Sciences, Medtronic, Abbott, and Baylis Medical and is a consultant for 4C Medical. Dr Khalique is a consultant for Edwards, Abbott Structural, Triflo, Cardiac Implants, Restore Medical, and Croivalve and is a member of a corelab (he receives no direct industry compensation) with contracts with Ancora, Jenavalve, Atricure, and Abbott Structural and holds equity in Triflo and Cardiac Implants. Dr Jilaihawi has received consulting fees from Edwards Lifesciences, St. Jude Medical, and Venous MedTech. Dr Thourani has received grants or is an advisor for Abbott Vascular, Artivion, Atricure, Boston Scientific, Croi Valve, Edwards Lifesciences, Jenavalve, Shockwave, and Trisol and holds equity in Dasi Simulations. Dr Makkar received grant support from Edwards and is a consultant for Abbott, Cordis, and Medtronic. Dr Leon has received institutional grants for clinical research from Abbott, Boston Scientific, Edwards, JenaValve, and Medtronic; has received stock options (equity) for advisory board participation in Valve Medical, Picardia, and Venus MedTech. Dr Mack served as coprimary investigator for the PARTNER trial (The Placement of Aortic Transcatheter Valves) for Edwards Lifesciences and the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) for Abbott and served as study chair for the APOLLO trial (Transcatheter Mitral Valve Replacement With the Medtronic Intrepid TMVR System in Patients With Severe Symptomatic Mitral Regurgitation) for Medtronic. Dr Tang is a physician proctor, consultant, and advisory board member for Medtronic; a consultant and physician advisory board member for Abbott Structural Heart; and a physician advisory board member for Boston Scientific and JenaValve. Dr Madhavan has received an institutional educational grant to Columbia University from Boston Scientific Corporation. The other authors report no conflicts.

Background: Coronary obstruction and access are concerns in patients undergoing redo transcatheter aortic valve implantation (TAVI)., Aims: We sought to assess the neoskirt height, leaflet overhang, leaflet deflection,and transcatheter heart valve (THV) expansion and performance, at 2 different implant depths, of the SAPIEN 3 Ultra (S3U) within the ACURATE neo2 (ACn2) THV., Methods: An in vitro study was performed with a 23 mm S3U deployed within a small (S) ACn2 and a 26 mm S3U deployed within a medium (M) and a large (L) ACn2. The S3U outflow was positioned at the top of the ACn2 crown (low implant) and at the base of the commissural post of the ACn2 (high implant). Testing was performed under physiological conditions as per ISO-5840-3 standard., Results: The neoskirt height was shorter when the S3U outflow was positioned at a low implantation depth (S: 9.6 mm, M: 12.2 mm, L: 13.8 mm vs S: 15.2 mm, M: 15.1 mm, L: 17.8 mm ACn2 for high implants). Hydrodynamic performance was acceptable for all configurations. Leaflet overhang was <50% for all configurations except the low implant of the 26 mm S3U in the L ACn2 (77.6%). There was a gap from the side of the neoskirt to the outer border of the THV frame which was >2 mm for all configurations. The S3U was underexpanded for all configurations, and the achieved area was 77.9%-92.9% of the expected nominal area., Conclusions: Redo TAVI with an S3U within an ACn2 has favourable hydrodynamics and moderate leaflet overhang. Importantly, the design of the ACn2 results in a neoskirt that is not deflected all the way to the outer dimensions of the THV, hence creating a space that facilitates coronary flow and access.

Aims: Paravalvular regurgitation (PVR) after transcatheter aortic valve implantation (TAVI) is associated with increased morbidity and mortality. The effect of transcatheter interventions to treat PVR after the index TAVI was investigated., Methods and Results: A registry of consecutive patients who underwent transcatheter intervention for ≥ moderate PVR after the index TAVI at 22 centers. The principal outcomes were residual aortic regurgitation (AR) and mortality at 1 year after PVR treatment. A total of 201 patients were identified: 87 (43%) underwent redo-TAVI, 79 (39%) plug closure, and 35 (18%) balloon valvuloplasty. Median TAVI-to-re-intervention time was 207 (35; 765) days. The failed valve was self-expanding in 129 (63.9%) patients. The most frequent devices utilized were a Sapien 3 valve for redo-TAVI (55, 64%), an AVP II as plug (33, 42%), and a True balloon for valvuloplasty (20, 56%). At 30 days, AR ≥ moderate persisted in 33 (17.4%) patients: 8 (9.9%) after redo-TAVI, 18 (25.9%) after plug, and 7 (21.9%) after valvuloplasty (P = 0.036). Overall mortality was 10 (5.0%) at 30 days and 29 (14.4%) at 1 year: 0, 8 (10.1%), and 2 (5.7%) at 30 days (P = 0.010) and 11 (12.6%), 14 (17.7%), and 4 (11.4%) at 1 year (P = 0.418), after redo-TAVI, plug, and valvuloplasty, respectively. Regardless of treatment strategy, patients in whom AR was reduced to ≤ mild had lower mortality at 1 year compared with those with AR persisting ≥ moderate [11 (8.0%) vs. 6 (21.4%); P = 0.007]., Conclusion: This study describes the efficacy of transcatheter treatments for PVR after TAVI. Patients in whom PVR was successfully reduced had better prognosis. The selection of patients and the optimal PVR treatment modality require further investigation., Competing Interests: Conflict of interest J.G.W.: consultant to, and has received research funding from, Edwards Lifesciences, Abbott Vascular, and Boston Scientific. W-K.K.: proctor or speaker fees from Boston Scientific, Abbott, Edwards Lifesciences, Medtronic, Meril Life Sciences. M.A-W.: received speaker's honoraria and/or consultancy fees on his behalf from Boston Scientific and Medtronic. M.B.: consultant for Edwards Lifesciences, Medtronic, and Boston Scientific. L.S.: consultant fees and institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Symetis. C.H.: Advisory Board Medtronic. J.M. Sinning: speaker honoraria and research grants from Medtronic, Boston Scientific, and Edwards Lifesciences. J.S.: consultant to Edwards Lifesciences. M. Andreas: proctor/consultant/speaker for Edwards, Abbott, and Medtronic, received institutional grants (Edwards, Abbott, Medtronic, and LSI). Dr. M. Guerrero: research grant support from Abbott Vascular and Edwards Lifesciences. F. Castriota: proctor for Medtronic and Boston Scientific. T.N.: consulting or honoraria from Edwards Lifesciences, Medtronic, and Boston Scientific. Consulting and equity with Venus MedTech. T.P.: research grants from Boston Scientific, Edwards Lifesciences, and Biotronik; speaker fees/consultancy fees from Boston Scientific, Medtronic, Abbott, Biotronik, and HighLife SAS. V.C. Babaliaros: consultant to Edwards Lifesciences and equity in transmural system. M.M.: consultant fee from Abbott, Boston, Kardia, and Medtronic. N.V.M.: institutional research grants and consulting fees from Abbott, Boston Scientific, Medtronic, Daiichi Sankyo, and PulseCath BV and institutional research grant support from Edwards Lifesciences. A.L.: institutional research/grant support from Abbott, Boston Scientific, Medtronic, and Edwards Lifesciences; and personal consulting honoraria from Abbott, Edwards Lifesciences and Medtronic. D.H-S.: proctor and advisory to Boston, Medtronic, Edwards Lifesciences, and Abbott. R.M. received grant support from Edwards Lifesciences Corporation; he is a consultant for Abbott Vascular, Cordis, and Medtronic and holds equity in Entourage Medical. All other authors have no conflict of interest to report in relation with this manuscript., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Para-valvular regurgitation (PVR) after transcatheter aortic valve (TAV) implantation is associated with increased mortality. Redo-TAVI may be applied to treat PVR, yet with unknown efficacy. We thought to assess redo-TAVI efficacy in reducing PVR using the Redo-TAVI registry (45 centers; 600 TAV-in-TAV cases)., Methods: Patients were excluded if redo-TAVI was done urgently (N = 253), for isolated TAV stenosis (N = 107) or if regurgitation location at presentation remained undetermined (N = 123). The study group of patients with PVR (N = 70) were compared against patients with intra-valvular regurgitation (IVR) (N = 41). Echocardiographic examinations of 67 (60%) patients were reassessed in a core-lab for data accuracy validation., Results: Core-lab examination validated the jet location in 66 (98.5%) patients. At 30 days, the rate of residual AR ≥ moderate was 7 (10%) in the PVR cohort vs. 1 (2.4%) in the IVR cohort, p = 0.137. The rate of procedural success was 53 (75.7%) vs. 33 (80.5%), p = 0.561; procedural safety 51 (72.8%) vs. 31 (75.6%), p = 0.727; and mortality 2 (2.9%) vs. 1 (2.4%), p = 0.896 at 30 days and 7 (18.6%) vs. 2 (11.5%), p = 0.671 at 1 year, respectively. Of patients with residual PVR ≥ moderate at 30 days, 5/7 occurred after implanting balloon-expandable in self-expanding TAV and 2/7 after balloon-expandable in balloon-expandable TAV., Conclusions: This study puts in perspective redo-TAVI efficacy and limitations to treat PVR after TAVI. Patient selection for this and other therapies for PVR needs further investigation., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Transcatheter aortic valve replacement (TAVR) is increasingly being performed in younger and lower surgical risk patients. Given the longer life expectancy of these patients, the bioprosthetic valve will eventually fail, and aortic valve reintervention may be necessary. Although currently rare, redo-TAVR will likely increase in the future as younger patients are expected to outlive their transcatheter bioprosthesis. This review provides a contemporary overview of the indications, procedural planning, implantation technique, and outcomes of TAVR in failed transcatheter bioprosthetic aortic valves., Competing Interests: Funding Support and Author Disclosures Dr Tarantini has received lecture fees from Medtronic, Edwards Lifesciences, Abbott, and Boston Scientific. Dr Sathananthan is a consultant to Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Khan is an inventor on patents, assigned to the National Institutes of Health, on leaflet laceration technology. Dr Van Mieghem has received research grant support from Abbott Vascular, Boston Scientific, Biotronik, Edwards Lifesciences, Medtronic, Daiichi Sankyo, Abiomed, PulseCath BV, Siemens, and Pie Medical. Dr Latib is an advisory and/or consultant for Medtronic, Abbott, Boston Scientific, Edwards Lifesciences, Philips, NeoChord, Shifamed, and Vahaticor. Dr Waksman is on the advisory board for Abbott, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd; is a consultant for Abbott, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd, Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc, and Venous MedTech; has received grant support from AstraZeneca, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT; is on the Speakers Bureau for AstraZeneca; and is an investor for MedAlliance and Transmural Systems Inc. Dr De Backer has received institutional research grants and consulting fees from Abbott and Boston Scientific. Dr Rogers is a consultant and proctor for Medtronic and Edwards Lifesciences; is on the advisory board for Medtronic; has equity interest in Transmural Systema; and is a coinventor on patents, assigned to National Institutes of Health, for transcatheter electrosurgery devices. Dr Søndergaard has received consultant fees and/or institutional research grants from Abbott, Boston Scientific, Medtronic and SMT. Dr Tang is a physician proctor and consultant for Medtronic; is a consultant and physician advisory board member for Abbott Structural Heart; is a physician advisory board member for JenaValve; and is a consultant for NeoChord. 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.)

Competing Interests: Funding Support and Author Disclosures Funding was received from St Paul's Foundation and the Providence Health Care Research Institute (PHCRI) Early Career Research Initiative. Dr Akodad has received research funding from Medtronic, Biotronik, MUSE Explore, and Federation Française de Cardiologie. Dr Sathananthan has received speaker fees from Edwards Lifesciences and NVT Medical; and has reported consulting for Edwards Lifesciences, Boston Scientific, and Medtronic. Dr Tzimas has reported support from the Fondation Vaudoise de Cardiologie. Dr Gulsin has reported support from a British Heart Foundation Travel Fellowship (FS/TF/21/33008). Dr Blanke has reported consulting for Edwards Lifesciences, Boston Scientific, and Neovasc; and has provided computed tomography core laboratory services for Edwards Lifesciences, Medtronic, Neovasc, Boston Scientific, and Abbott, for which no direct compensation was received. Dr Sondergaard has received consultant fees and/or institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and SMT. Dr Wood has reported consulting for and has received research funding from Edwards Lifesciences and Abbott. Dr Webb has reported consulting for Edwards Lifesciences. Dr Leipsic has reported support from a Canadian Research Chair in Advanced Cardiopulmonary Imaging; has reported consulting for MVRX, HeartFlow, and Circle Cardiovascular Imaging; and has provided computed tomography core laboratory services for Edwards Lifesciences, Medtronic, Neovasc, Boston Scientific, and Abbott, for which no direct compensation is received. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Background: As transcatheter aortic valve (TAV) replacement is increasingly used in patients with longer life expectancy, a sizable proportion will require redo TAV replacement (TAVR). The unique configuration of balloon-expandable TAV (bTAV) vs a self-expanding TAV (sTAV) potentially affects TAV-in-TAV outcome., Objectives: The purpose of this study was to better inform prosthesis selection, TAV-in-TAV outcomes were assessed according to the type of initial and subsequent TAV., Methods: Patients from the Redo-TAVR registry were analyzed using propensity weighting according to their initial valve type (bTAV [n = 115] vs sTAV [n = 106]) and subsequent valve type (bTAV [n = 130] vs sTAV [n = 91])., Results: Patients with failed bTAVs presented later (vs sTAV) (4.9 ± 2.1 years vs 3.7 ± 2.3 years; P < 0.001), with smaller effective orifice area (1.0 ± 0.7 cm 2 vs 1.3 ± 0.8 cm 2 ; P = 0.018) and less frequent dominant regurgitation (16.2% vs 47.3%; P < 0.001). Mortality at 30 days was 2.3% (TAV-in-bTAV) vs 0% (TAV-in-sTAV) (P = 0.499) and 1.7% (bTAV-in-TAV) vs 1.0% (sTAV-in-TAV) (P = 0.612); procedural safety was 72.6% (TAV-in-bTAV) vs 71.2% (TAV-in-sTAV) (P = 0.817) and 73.2% (bTAV-in-TAV) vs 76.5% (sTAV-in-TAV) (P = 0.590). Device success was similar according to initial valve type but higher with subsequent sTAV vs bTAV (77.2% vs 64.3%; P = 0.045), primarily because of lower residual gradients (10.3 mm Hg [8.9-11.7 mm Hg] vs 15.2 mm Hg [13.2-17.1 mm Hg]; P < 0.001). Residual regurgitation (moderate or greater) was similar after bTAV-in-TAV and sTAV-in-TAV (5.7%) and nominally higher after TAV-in-bTAV (9.1%) vs TAV-in-sTAV (4.4%) (P = 0.176)., Conclusions: In selected patients, no association was observed between TAV type and redo TAVR safety or mortality, yet subsequent sTAV was associated with higher device success because of lower redo gradients. These findings are preliminary, and more data are needed to guide valve choice for redo TAVR., Competing Interests: Funding Support and Author Disclosures Dr Webb is a consultant to and has received research funding from Edwards Lifesciences, Abbott Vascular, and Boston Scientific. Dr Kim is a proctor for and has received speaker fees from Boston Scientific, Abbott, Edwards Lifesciences, and Medtronic. Dr Abdel-Wahab has received speaker honoraria and/or consultancy fees to the hospital on his behalf from Boston Scientific and Medtronic. Dr Barbanti is a consultant for Edwards Lifesciences; and is an advisory board member for Biotronik. Dr Søndergaard has received consulting 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 Lifesciences. 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 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 Andreas is a proctor, consultant, and speaker for Edwards Lifesciences, Abbott, and Medtronic; and has received institutional grants from Edwards Lifesciences, Abbott, Medtronic, and LSI. Dr Guerrero has received research grant support from Abbott Vascular and Edwards Lifesciences. Dr Castriota is a proctor for Medtronic and Boston Scientific. Dr Nazif is a consultant for or has received honoraria from Edwards Lifesciences, Medtronic, Boston Scientific, Biotrace, and Baylis Medical; and is a consultant for 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 and 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 for 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 © 2022. Published by Elsevier Inc.)

Bioprosthetic valve dysfunction (BVD) and bioprosthetic valve failure (BVF) may be caused by structural or nonstructural valve dysfunction. Both surgical and transcatheter bioprosthetic valves have limited durability because of structural valve deterioration. The main objective of this summary of experts participating in a virtual workshop was to propose standardized definitions for nonstructural and structural BVD and BVF following aortic or mitral biological valve replacement with the goal of facilitating research reporting and implementation of these terms in clinical practice. Definitions of structural BVF, based on valve reintervention or death, underestimate the true incidence of BVF. However, definitions solely based on the presence of high transprosthetic gradient at a given echocardiogram during follow-up overestimate the incidence of structural BVD and BVF. Definitions of aortic or mitral structural BVD must therefore include the confirmation by imaging of permanent structural changes to the leaflets alongside evidence of deterioration in valve hemodynamic function at echocardiography follow-up., 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 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 Hahn has received speaker fees from Abbott Structural, Edwards Lifesciences, and Philips Healthcare; has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic and Novartis; and has equity in Navigate. Dr Abbas has received research grants and consulting fees from Edwards Lifesciences. Dr Dweck has served as a consultant to Edwards Lifesciences and Medtronic; has received research funding from Edwards Lifesciences and Medtronic; and has received speaking fees from NVT. Dr Leipsic has served as a consultant for Circle CVI and MVRX; and has received institutional funding for CT core laboratory analyses from Edwards Lifesciences, Neovasc, Abbott, Medtronic, Boston Scientific, PI Cardia, and Conformal. Dr Rogers has served as a consultant and physician proctor for Edwards Lifesciences and Medtronic; has served as an advisory board member for Medtronic; and holds equity interest in Transmural Systems. Dr Sathananthan has served as a consultant to Edwards Lifesciences and Medtronic; has received research funding from Edwards Lifesciences and Medtronic; and has received speaking fees from NVT. Dr Guerrero has received institutional research grant support from Edwards Lifesciences. Dr Ternacle has served as a consultant for Philips Healthcare and Abbott Medical. Dr Barbanti has served as a consultant for Edwards Lifesciences and Boston Scientific. Dr Généreux has served as a consultant and advisor for and received speaker fees from Abbott Vascular, Abiomed, BioTrace Medical, and Medtronic; has served as a consultant for Boston Scientific, GE Healthcare, iRhythm Technologies, Opsens, Siemens, and Teleflex; has served as a consultant, PI Eclipse Trial, for Cardiovascular System Inc; has served as a consultant, advisor, and proctor for and received speaker fees and research grant from Edwards LifeSciences for the PI EARLY-TAVR and PI PROGRESS trials; has served as a consultant for and has equity in Pi-Cardia, Puzzle Medical, Saranas, and Soundbite Medical Inc; has served as a consultant for and received speaker fees from Shockwave; and has served as a consultant for the PI Feasibility study for 4C Medical. Dr Kaneko has served as a consultant for Edwards Lifesciences, Medtronic, and Abbott Structural. Dr Wood has served as a consultant to and his institution (CCI-CIC) receives grant support from Edwards Lifesciences, Abbott Vascular, and Medtronic. Dr Gillam has served as a consultant to Philips and Bracco; is an advisory board member for Edwards Lifesciences; and has core lab contracts with Edwards Lifesciences, Medtronic, and Abbott for which she receives no direct compensation. Dr Reardon has served as a consultant for Medtronic, Boston Scientific, Abbott Medical, and Gore Medical; all fees for such are to his department. Dr Rodes-Cabau has received institutional research grants from Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Thourani has performed consulting/research for Abbott Vascular, Boston Scientific, Cryolife, Edwards Lifesciences, Medtronic, and Shockwave. Dr Bax’s institution (Department of Cardiology, LUMC, the Netherlands) has received research grants from Medtronic, Biotronik, Edwards Lifesciences, and Boston Scientific. 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 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Data on outcomes of transcatheter aortic valve replacement (TAVR) using balloon-expandable valves (BEVs) or self-expandable valves (SEVs) as well as the impact of center valve preference on these outcomes are limited., Objectives: The aim of this study was to compare outcomes of TAVR procedures using third-generation BEVs and SEVs stratified by center valve preference., Methods: In a multicenter registry (n = 17), 13 centers exhibited valve preference (66.6%-90% of volume) and were included. Outcomes were compared between BEVs and SEVs stratified by center valve preference., Results: In total, 7,528 TAVR procedures (3,854 with SEVs and 3,674 with BEVs) were included. The mean age was 81 years, and the mean Society of Thoracic Surgeons score was 5.2. Baseline characteristics were similar between BEVs and SEVs. Need for pacemaker implantation was higher with SEVs at BEV- and SEV-dominant centers (17.8% vs 9.3% [P < 0.001] and 12.7% vs 10.0% [P = 0.036], respectively; HR: 1.51; P for interaction = 0.021), risk for cerebrovascular accident was higher with SEVs at BEV-dominant but not SEV-dominant centers (3.6% vs 1.1% [P < 0.001] and 2.2% vs 1.4% [P = 0.162]; HR: 2.08; P for interaction < 0.01). Aortic regurgitation greater than mild was more frequent with SEVs at BEV-dominant centers and similar with BEVs regardless of center dominance (5.2% vs 2.8% [P < 0.001] and 3.4% vs 3.7% [P = 0.504], respectively). Two-year mortality was higher with SEVs at BEV-dominant centers but not at SEV-dominant centers (21.9% vs 16.9% [P = 0.021] and 16.8% vs 16.5% [P = 0.642], respectively; HR: 1.20; P for interaction = 0.032)., Conclusions: Periprocedural outcomes, aortic regurgitation greater than mild, and 2-year mortality are worse when TAVR is performed using SEVs at BEV-dominant centers. Outcomes are similar regardless of valve type at SEV-dominant centers. The present results stress the need to account for this factor when comparing BEV and SEV outcomes. (The Aortic+Mitral Transcatheter [AMTRAC] Valve Registry; NCT04031274)., Competing Interests: Funding Support and Author Disclosures Dr Van Miegham has received research grant support from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, PulseCath BV, and Daiichi-Sankyo; and has received advisory fees from Abbott, Boston Scientific, Ancora, Medtronic, PulseCath BV, and Daiichi-Sankyo. Dr Barbanti has received consulting fees from Edwards Lifesciences. Dr Grasso is a proctor for Abbott Vascular. Dr De Backer has received research grants and consulting fees from Abbott and Boston Scientific. Dr Andreas is a proctor for Abbott and Edwards Lifesciences; and has received advisory board fees from Medtronic. Dr Estévez-Loureiro is a consultant for Abbott Vascular and Boston Scientific. Dr Nombela-Franco has received consulting fees from Edwards Lifesciences; and is a proctor for Abbott. Dr Søndergaard has received consulting fees and/or institutional research support from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and SMT. Dr Amat-Santos is a proctor for Boston Scientific. Dr Finkelstein is a proctor for Edwards Lifesciences and Medtronic; and has received consulting fees from Edwards Lifesciences and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The choice between mechanical valves (MVs) and bioprosthetic valves (BVs) in patients undergoing aortic valve surgery is complex, requiring a balance between the inferior durability of BV and the indicated long-term anticoagulation therapy with MV. This is especially challenging in the middle age group (< 70 years), which has seen an increased use of BV over recent years., Methods: A meta-analysis of randomised controlled trials (RCTs), observational studies using propensity score matching (PSM) and inverse probability weighting (IPW) was conducted to examine the clinical outcomes of patients < 70 years of age undergoing aortic valve replacement. The primary outcome was overall long-term mortality. Secondary outcomes included bleeding events, reoperation, systemic thromboembolism, and cerebrovascular accident., Results: Fifteen studies (1 RCT, 12 PSM studies, and 2 IPW studies; aggregated sample size 16,876 patients) were included. Median follow-up was 7.8 years. Mortality was higher with BVs vs MVs (hazard ratio [HR] 1.22, 95% confidence interval [CI] 1.00-1.49), as was reoperation (HR 3.05, 95% CI 2.22-4.19). Bleeding risk was lower with BVs (HR 0.58, 95% CI 0.48-0.69), and the risk of stroke was similar in both valve types (HR 0.96, 95% CI 0.83-1.11) CONCLUSIONS: This broadest meta-analysis comparing BV and MV suggests a survival benefit for MVs in patients < 70 years of age. This should lead to reassessment of current patterns used in the choice of valves for patients < 70 among the cardiothoracic surgery community., (Copyright © 2021 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to determine the degree of Evolut (Medtronic) leaflet pinning, diameter expansion, leaflet overhang, and performance at different implant depths of the balloon-expandable Sapien 3 (S3, Edwards Lifesciences LLC) transcatheter heart valve (THV) within the Evolut THV., Background: Preservation of coronary access and flow is a major factor when considering the treatment of failed Evolut THVs., Methods: An in vitro study was performed with 20-, 23-, 26-, and 29-mm S3 THVs deployed within 23-, 26-, 29-, and 34-mm Evolut R THVs, respectively. The S3 outflow was positioned at various depths at node 4, 5, and 6 of the Evolut R. Neoskirt height, leaflet overhang, performance, and Evolut R valve housing diameter expansion were assessed under physiological conditions as per ISO 5840-3 standard., Results: The neoskirt height for the Evolut R was shorter when the S3 outflow was positioned at node 4 compared with node 6 (node 4 height for 23 mm = 16.3 mm, 26 mm = 17.1 mm, 29 mm = 18.3 mm, and 34 mm = 19.9 mm vs node 6 height for 23 mm = 23.9 mm, 26 mm = 23.4 mm, 29 mm = 24.7 mm, and 34 mm = 27 mm Evolut R). All configurations exhibited acceptable hydrodynamic performance irrespective of the degree of leaflet overhang, except the 29-mm S3 implanted in 34-mm Evolut R at node 4 (regurgitant fraction >20%). The valve housing radius of the index Evolut R increased when the S3 was implanted, with the increase ranging from 0 to 2.5 mm., Conclusions: Placement of the S3 at a lower implant position within an index Evolut R reduces the neoskirt height with no significant compromise to S3 valve function despite a higher degree of leaflet overhang. Low S3 implantation may facilitate future coronary access after redo transcatheter aortic valve replacement., Competing Interests: Funding Support and Author Disclosures Funding for the study was provided by Medtronic. Dr Akodad has received research funding from Medtronic, Biotronik, MUSE Explore, and Federation Française de Cardiologie. Dr Tang is a physician proctor and consultant for Medtronic; is a consultant for Abbott Structural Heart and NeoChord; and is a physician advisory board member for Abbott Structural Heart and JenValve. Dr Gada is a consultant for Abbott Vascular, Bard Medical, Boston Scientific, and Medtronic. Dr Rogers is a consultant and physician proctor to Edwards Lifesciences and Medtronic; has equity in Transmural Systems; and is a co-inventor on dedicated electrosurgery devices assigned to NIH. Dr Rutkin serves as a consultant for Medtronic. Dr Puri is a consultant to Medtronic, Boston Scientific, Philips, Bioventrix, Products & Features, Shockwave Medical, Centerline Biomedical, and VDyne. Dr Rovin is a physician proctor with Medtronic and Abbott; and is a Speakers Bureau for Medtronic and Abbott. Dr Leipsic holds institutional research core lab agreements with Medtronic, Edwards Lifesciences, Abbott, Boston Scientific, and Pi CARDIA. Dr Caskey serves as a proctor for Medtronic. Dr Sondergaard has received consultant fees and/or institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Sahajanand Medical Technology. Dr Grubb is a speaker, proctor, and principal investigator for Edwards Lifesciences; is a speaker, proctor, and principal investigator for Medtronic; and her employer receives institutional grants and educational funding from Edwards Lifesciences and Medtronic. Dr Gleason’s employer receives institutional grants and educational funding from Edwards Lifesciences and Medtronic; he has no personal financial disclosures. Ms Garde, Mr Tadros, and Mr Teodoru are all employees and shareholders of Medtronic. Dr Wood is a consultant and receives unrestricted grant support from Medtronic, Edwards Lifesciences, and Abbott Vascular. Mr Sathananthan is a consultant to Edwards Lifesciences and Medtronic; and has received speaking fees from Edwards Lifesciences and NVT. 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.)

Background: Transcatheter aortic valve replacement (TAVR) is safe and feasible in patients with bicuspid aortic valve (BAV), but whether annular size may influence TAVR results in BAV patients remains unclear. We aimed at evaluating the impact of aortic annular size on procedural and clinical outcomes of BAV patients undergoing TAVR, as well as potential interactions between annular dimension and trans-catheter heart valve (THV) type (balloon-expandable (BEV) vs. self-expanding (SEV)., Methods: BEAT is a multicenter registry of consecutive BAV stenosis undergoing TAVR. For this sub-study patients were classified according to annular dimension in small-annulus (area < 400 mm 2 or perimeter <72 mm), medium-annulus (area ≥ 400 and < 575 mm 2 , perimeter ≥72 mm and< 85 mm), large-annulus (area ≥ 575 mm 2 or perimeter ≥85 mm). Primary endpoint was Valve Academic Research Consortium-2 (VARC-2) device success., Results: 45(15.5%) patients had small, 132(45.3%) medium, and 114(39.2%) large annuli. Compared with other groups, patients with large annuli were more frequently male, younger, with higher body mass index, larger aortic valve area, higher rate of moderate-severe calcification, lower mean trans-aortic valve gradient and lower left ventricular ejection fraction. In large-annuli SEVs were associated with a lower VARC-2 device success (75.9% vs. 90.6%, p = 0.049) driven by a higher rate of paravalvular valvular leak (PVL) compared to BEVs (20.7% vs. 1.2%, p < 0.001). However, no differences in clinical outcomes were observed according to annular size nor THV type., Conclusions: TAVR in BAV patients is feasible irrespective of annular size. However in patients with large aortic annulus SEVs were associated with a significantly higher rate of PVLs compared to BEVs., (Copyright © 2021. Published by Elsevier B.V.)

Background: Bioprosthetic valve fracture (BVF) is a technique to reduce gradients in valve-in-valve transcatheter aortic valve implantation (VIV-TAVI) procedures. The outcome of VIV-TAVI with BVF has not been compared with VIV-TAVI without BVF., Aims: The aim of this study was to evaluate the outcome of VIV-TAVI with BVF compared to VIV-TAVI without BVF., Methods: In total, 81 cases of BVF VIV-TAVI (BVF group) from 14 centres were compared to 79 cases of VIV-TAVI without BVF (control group)., Results: VARC-2-defined device success was 93% in the BVF group and 68.4% in the control group (p<0.001). The mean transvalvular gradient decreased from 37±13 mmHg to 10.8±5.9 mmHg (p<0.001) in the BVF group and from 35±16 mmHg to 15.8±6.8 mmHg (p<0.001) in the control group with a significantly higher final gradient in the control group (p<0.001). The transvalvular gradients did not change significantly over time. In-hospital major adverse events occurred in 3.7% in the BVF group and 7.6% in the control group (p=0.325). A linear mixed model identified BVF, self-expanding transcatheter heart valves (THVs) and other surgical aortic valve (SAV) types other than Mitroflow as predictors of lower transvalvular gradients., Conclusions: Compared to VIV-TAVI alone, VIV-TAVI with BVF resulted in a significantly lower transvalvular gradient acutely and at follow-up. Independent predictors of lower gradients were the use of self-expanding THVs and the treatment of SAVs other than Mitroflow, irrespective of BVF performance. BVF significantly reduced the gradient independently from transcatheter or surgical valve type.

Background: THV implantation within failed surgical valves is well established. However, the implications of THV implantation within failed THVs are poorly understood., Aims: This study aimed to assess the impact of different transcatheter heart valve (THV) designs and implant positioning strategies on hydrodynamic performance after redo transcatheter aortic valve implantation (TAVI)., Methods: THVs of varying design (SAPIEN 3, Evolut PRO, ACURATE neo, ALLEGRA, and Portico) and size were implanted inside SAPIEN XT and Evolut R THVs. Hydrodynamic function as per International Organization for Standardization (ISO) specifications was evaluated using a pulse duplicator, and multi-modality imaging was performed., Results: The majority of tested THV-in-THV combinations resulted in stable anchoring of the new implant. However, some combinations resulted in unstable anchoring with the potential for dislodgement or embolisation. Hydrodynamic function was favourable for all tested THV designs implanted in the intra-annular SAPIEN XT THV. SAPIEN 3 implantation within an Evolut THV with supra-annular leaflets must be appropriately sized to ensure adequate anchoring. Avoidance of an intra-annular deployment mitigated leaflet overhang of the Evolut leaflets and optimised hydrodynamic performance., Conclusions: This study demonstrates that most THV designs and implantation strategies can result in favourable hydrodynamic performance following redo TAVI. Whether the leaflets of a failed THV are intra- or supra-annular may have important implications for the positioning of a redo-THV implant. Certain THV designs or implantation positions may be more desirable when performing redo TAVI.

Objectives: To evaluate outcome and its predictors of bioprosthetic valve fracture (BVF) in patients undergoing valve-in-valve transcatheter aortic valve replacement (VIV-TAVR)., Background: BVF is feasible and reduces transvalvular gradients in VIV-TAVR-procedures, but follow-up-data and information on factors influencing the outcome are missing., Methods: The 81 cases of BVF-VIV-TAVR were collected from 14 international centers., Results: Predominantly transcatheter heart valve (THV) was implanted first, followed by BVF. VARC-2 defined device success was 93%, most failures were attributed to residual high gradients. Mean gradients decreased from 37 ± 13 mmHg to 10.8 ± 5.9 mmHg (p < 0.001). BVF reduced the gradient by 16 mmHg. During follow-up (FU, 281 ± 164 days) mean gradient remained stable (10.8 ± 5.9 mmHg at discharge, 12.4 ± 6.3 mmHg at FU, p = ns). In-hospital major adverse events occurred in 3.7%. Event-free survival at 276 ± 237.6 days was 95.4%. The linear mixed model identified balloon-expandable valves (BEV), Mitroflow surgical valve, stenotic surgical bioprostheses and balloon only 1 mm larger than the true internal diameter of the surgical valve as predictors for higher gradients., Conclusions: BVF is safe and can significantly reduce gradients, which remain stable at FU. BEV, Mitroflow surgical valve, stenotic bioprostheses and balloon larger than the true internal diameter of the surgical valve of only 1 mm are predictors for higher final gradients., (© 2021 Wiley Periodicals LLC.)

Background: Mitral valve-in-valve (ViV) and valve-in-ring (ViR) are alternatives to surgical reoperation in patients with recurrent mitral valve failure after previous surgical valve repair or replacement. Our aim was to perform a large-scale analysis examining midterm outcomes after mitral ViV and ViR., Methods: Patients undergoing mitral ViV and ViR were enrolled in the Valve-in-Valve International Data Registry. Cases were performed between March 2006 and March 2020. Clinical endpoints are reported according to the Mitral Valve Academic Research Consortium (MVARC) definitions. Significant residual mitral stenosis (MS) was defined as mean gradient ≥10 mm Hg and significant residual mitral regurgitation (MR) as ≥ moderate., Results: A total of 1079 patients (857 ViV, 222 ViR; mean age 73.5±12.5 years; 40.8% male) from 90 centers were included. Median STS-PROM score 8.6%; median clinical follow-up 492 days (interquartile range, 76-996); median echocardiographic follow-up for patients that survived 1 year was 772.5 days (interquartile range, 510-1211.75). Four-year Kaplan-Meier survival rate was 62.5% in ViV versus 49.5% for ViR ( P <0.001). Mean gradient across the mitral valve postprocedure was 5.7±2.8 mm Hg (≥5 mm Hg; 61.4% of patients). Significant residual MS occurred in 8.2% of the ViV and 12.0% of the ViR patients ( P =0.09). Significant residual MR was more common in ViR patients (16.6% versus 3.1%; P <0.001) and was associated with lower survival at 4 years (35.1% versus 61.6%; P =0.02). The rates of Mitral Valve Academic Research Consortium-defined device success were low for both procedures (39.4% total; 32.0% ViR versus 41.3% ViV; P =0.01), mostly related to having postprocedural mean gradient ≥5 mm Hg. Correlates for residual MS were smaller true internal diameter, younger age, and larger body mass index. The only correlate for residual MR was ViR. Significant residual MS (subhazard ratio, 4.67; 95% CI, 1.74-12.56; P =0.002) and significant residual MR (subhazard ratio, 7.88; 95% CI, 2.88-21.53; P <0.001) were both independently associated with repeat mitral valve replacement., Conclusions: Significant residual MS and/or MR were not infrequent after mitral ViV and ViR procedures and were both associated with a need for repeat valve replacement. Strategies to improve postprocedural hemodynamics in mitral ViV and ViR should be further explored.

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.)

Objectives: The aim of this study was to assess coronary accessibility after transcatheter aortic valve replacement (TAVR)-in-TAVR using multidetector computed tomography., Background: Expanding TAVR to patients with longer life expectancy may involve more frequent bioprosthetic valve failure and need for redo TAVR. Coronary access after TAVR-in-TAVR may be challenging, particularly as the leaflets from the initial transcatheter heart valve (THV) will form a neo-skirt following TAVR-in-TAVR., Methods: In 45 patients treated with different combinations of CoreValve and Evolut (CV/EV) THVs with supra-annular leaflet position and SAPIEN THVs with intra-annular leaflet position, post-TAVR-in-TAVR multidetector computed tomographic scans were analyzed to examine coronary accessibility., Results: After TAVR-in-TAVR, the coronary arteries originated below the top of the neo-skirt in 90% of CV/EV-first cases compared with 67% of SAPIEN-first cases (p = 0.009). For these coronary arteries originating below the top of the neo-skirt, the distance between the THV and the aortic wall was <3 mm in 56% and 25% of CV/EV-first and SAPIEN-first cases, respectively (p = 0.035). Coronary access may be further complicated by THV-THV stent frame strut misalignment in 53% of CV/EV-in-CV/EV cases. The risk for technically impossible coronary access was 27% and 10% in CV/EV-first and SAPIEN-first cases, respectively (p = 0.121). Absence of THV interference with coronary accessibility can be expected in 8% and 33% of CV/EV-first and SAPIEN-first cases, respectively (p = 0.005)., Conclusions: Coronary access after TAVR-in-TAVR may be challenging in a significant proportion of patients. THVs with intra-annular leaflet position or low commissural height and large open cells may be preferable in terms of coronary access after TAVR-in-TAVR., Competing Interests: Author Relationship With Industry Dr. De Backer has received institutional research grants and consulting fees from Abbott and Boston Scientific. Dr. Kim has been a proctor for and has received speaking fees from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Thomas Pilgrim has received institutional research grants and speaking fees from Biotronik and Boston Scientific; and is a consultant for HighLife SAS. Dr. Barbanti has received consulting fees from Edwards Lifesciences. Dr. Nombela-Franco has received consulting fees from Abbott, Boston Scientific, and Edwards Lifesciences. Dr. Kofoed has received institutional grants from AP Møller og Hustru Chastine McKinney Møllers Fond, the John and Birthe Meyer Foundation, The Research Council of Rigshopitalet, the University of Copenhagen, the Danish Heart Foundation, the Danish Agency for Science, Technology and Innovation by The Danish Council for Strategic Research, and Canon Medical Corporation. Dr. Windecker has received research and educational grants to the institution from Abbott, Amgen, Bristol Myers Squibb, Bayer, Boston Scientific, Biotronik, Cardinal Health, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Johnson & Johnson, Medtronic, Querbet, Polares, Sanofi, Terumo, and Sinomed. Dr. Sinning has received speaking honoraria and research grants from Abbott, Abiomed, Medtronic, Boston Scientific, and Edwards Lifesciences. Dr. Webb has received institutional research grants and consulting fees from Abbott, Boston Scientific, and Edwards Lifesciences. Prof. Dr. Søndergaard has received institutional research grants and consulting fees from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Symetis. 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.)

Aims: The commonly used valve-in-valve (VIV) app recommends sizing based on dimensions of both the transcatheter heart valve (THV) and bioprosthetic surgical valve. The implications of hydrodynamic testing to guide VIV sizing are poorly understood. This bench study assessed the hydrodynamic performance of different sizes of self-expanding supra-annular THVs in three different surgical aortic bioprostheses at different implantation depths., Methods: A small versus medium ACURATE neo (ACn), and a 26 mm versus 29 mm Evolut R were assessed after VIV implantation in 25 mm Mitroflow, Mosaic, and Magna Ease aortic surgical bioprostheses, at three implantation depths (+2 mm, -2 mm, and -6 mm)., Results: The medium-sized ACn had lower gradients compared to the small ACn when the THV was implanted high (+2 mm, or -2 mm). The 29 mm Evolut R had lower gradients compared to a 26 mm Evolut R for all implantation depths, except for a depth of -2 mm in the 25 mm Mitroflow. The medium ACn and 29 mm Evolut R had larger effective orifice areas compared to the small ACn and 26 mm Evolut R, respectively. Both Evolut R sizes had acceptable regurgitant fractions (<15%), while both ACn sizes were above the acceptable performance criteria (>15%), at all implantation depths., Conclusions: Use of a larger self-expanding THV was associated with superior hydrodynamic performance if the THV was implanted high. Hydrodynamic testing can provide additional information to the VIV app to help guide VIV sizing., (© 2019 Wiley Periodicals, Inc.)

Background: Large data comparing the performance of new-generation self-expandable versus balloon-expandable transcatheter heart valves in bicuspid aortic stenosis are lacking. We aim to compare the safety and performance of balloon-expandable and self-expandable transcatheter heart valves in the treatment of bicuspid aortic stenosis., Methods: The BEAT (balloon versus self-expandable valve for the treatment of bicuspid aortic valve stenosis) registry included 353 consecutive patients who underwent transcatheter aortic valve implantation using new-generation Evolut R/PRO or Sapien 3 valves in bicuspid aortic valve., Results: A total of 353 patients (n=242 [68.6%] treated with Sapien 3 and n=111 [68.6%] treated with Evolut R (n=70)/PRO [n=41]) were included. Mean age was 77.8±8.3 years and mean Society of Thoracic Surgeons Predicted Risk of Mortality was 4.4±3.3%. Valve Academic Research Consortium-2 device success was similar between Sapien 3 and Evolut R/PRO (85.6% versus 87.2%; P =0.68). In the Sapien 3 group, 4 patients experienced annular rupture whereas this complication did not occur in the Evolut R/PRO group. After propensity score matching, Valve Academic Research Consortium-2 device success was similar between both groups (Sapien 3=85.7% versus Evolut R/Pro=84.4%; P =0.821). Both in the overall and in the matched population, no differences in the rate of permanent pacemaker implant were observed. At 1-year follow-up, the rate of overall death and cardiovascular death were similar between the 2 groups. In the unmatched population, the 1-year echocardiographic follow-up demonstrated similar rate of moderate-to-severe paravalvular aortic regurgitation (Evolut R/PRO 10.5% versus Sapien 3 4.2%, P =0.077); however, after propensity matching, the rate of moderate-to-severe paravalvular leak became significantly higher among patients treated with self-expandable valves (9.3% versus 0%; P =0.043)., Conclusions: Our study confirms the feasibility of both Sapien 3 and Evolut R/PRO implantation in bicuspid aortic valve anatomy; a higher rate of moderate-severe paravalvular aortic regurgitation was observed in the Evolut R/PRO group at 1-year follow-up in the matched cohort, although patients treated with balloon-expandable valve had a higher rate of annular rupture.

Background: Transcatheter aortic valve replacement (TAVR) use is increasing in patients with longer life expectancy, yet robust data on the durability of transcatheter heart valves (THVs) are limited. Redo-TAVR may play a key strategy in treating patients in whom THVs fail., Objectives: The authors sought to examine outcomes following redo-TAVR., Methods: The Redo-TAVR registry collected data on consecutive patients who underwent redo-TAVR at 37 centers. Patients were classified as probable TAVR failure or probable THV failure if they presented within or beyond 1 year of their index TAVR, respectively., Results: Among 63,876 TAVR procedures, 212 consecutive redo-TAVR procedures were identified (0.33%): 74 within and 138 beyond 1 year of the initial procedure. For these 2 groups, TAVR-to-redo-TAVR time was 68 (38 to 154) days and 5 (3 to 6) years. The indication for redo-TAVR was THV stenosis in 12 (16.2%) and 51 (37.0%) (p = 0.002) and regurgitation or combined stenosis-regurgitation in 62 (83.8%) and 86 (62.3%) (p = 0.028), respectively. Device success using VARC-2 criteria was achieved in 180 patients (85.1%); most failures were attributable to high residual gradients (14.1%) or regurgitation (8.9%). At 30-day and 1-year follow-up, residual gradients were 12.6 ± 7.5 mm Hg and 12.9 ± 9.0 mm Hg; valve area 1.63 ± 0.61 cm 2 and 1.51 ± 0.57 cm 2 ; and regurgitation ≤mild in 91% and 91%, respectively. Peri-procedural complication rates were low (3 stroke [1.4%], 7 valve malposition [3.3%], 2 coronary obstruction [0.9%], 20 new permanent pacemaker [9.6%], no mortality), and symptomatic improvement was substantial. Survival at 30 days was 94.6% and 98.5% (p = 0.101) and 83.6% and 88.3% (p = 0.335) at 1 year for patients presenting with early and late valve dysfunction, respectively., Conclusions: Redo-TAVR is a relatively safe and effective option for selected patients with valve dysfunction after TAVR. These results are important for applicability of TAVR in patients with long life expectancy in whom THV durability may be a concern., (Copyright © 2020. Published by Elsevier Inc.)

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.)

Aims: We aimed to assess the impact of implant depth on hydrodynamic function following valve-in-valve (VIV) intervention using the ALLEGRA transcatheter heart valve (THV) in three different surgical valve designs., Methods and Results: Multiple implantation depths (+2 mm, -2 mm and -6 mm) were tested using a 23 mm ALLEGRA THV for VIV intervention in 19 mm, 21 mm, 23 mm, and 25 mm Epic, Mitroflow and Magna Ease bioprosthetic valves. Multimodality imaging and hydrodynamic evaluation was performed at each implantation depth. The 23 mm ALLEGRA valve had gradients <20 mmHg in the Mitroflow and Epic valves sized ≥21 mm, and in all sizes of the Magna Ease valve. Gradients did not increase significantly at lower implantation depths. The 19 mm Epic (+2 mm: 20.1±0.6 mmHg, -2 mm: 18.8±0.5 mmHg, -6 mm: 22.8±0.3 mmHg) and 19 mm Mitroflow (+2 mm: 24.1±0.2 mmHg, -2 mm: 31.5±0.3 mmHg, -6 mm: 25.6±0.2 mmHg) valves had elevated mean gradients. In larger sized surgical valves (≥23 mm) the regurgitant fraction was higher at low implantation depths. Pinwheeling was significantly worse in the smaller sized (≤21 mm) surgical valves and also at low (<-2 mm) implantation depth., Conclusions: The 23 mm ALLEGRA valve had favourable (<20 mmHg) gradients in all surgical valves sized ≥21 mm, even when the THV was implanted low. In 19 mm sized Mitroflow and Epic valves, gradients were elevated (>20 mmHg). While there was no major difference in mean transvalvular gradients, leaflet pinwheeling was worse at lower implantation depths.

Objectives: This study assessed the long-term durability of nominally deployed transcatheter heart valves (THV) to 1 billion cycles (equivalent to 25 years) and non-nominal (overexpansion, underexpansion, and elliptical) THV deployments to 200 million cycles (equivalent to 5 years) with accelerated wear testing., Background: The long-term durability of THVs is currently unknown. As transcatheter aortic valve replacement expands to lower-risk patients, durability will be of increasing importance., Methods: SAPIEN 3 THVs, sized 20, 23, 26, and 29 mm were assessed. Nominally deployed THVs underwent hydrodynamic performance and mechanical durability as assessed with accelerated wear testing to 1 billion cycles. Magna Ease surgical valves were used as comparators. Durability of non-nominal THV deployments was tested to 200 million cycles. Valves were tested to International Standards Organization 5840:2013 standard., Results: THV durability was excellent for both the nominal and non-nominal THV deployments to 1 billion and 200 million cycles, respectively. At 1 billion cycles the regurgitant fraction for the 20-, 23-, 26-, and 29-mm SAPIEN 3 was 0.92 ± 0.47%, 1.29 ± 0.04%, 1.73 ± 0.46%, and 2.47 ± 0.15%, respectively. There was also excellent durability in the comparator Magna Ease valves. The regurgitant fraction of non-nominal overexpanded (20 mm, 4.36 ± 0.53; 23 mm, 7.68 ± 1.39; 26 mm, 6.80 ± 1.17; 29 mm, 9.00 ± 0.37), underexpanded (20 mm, 3.06 ± 0.28; 23 mm, 4.46 ± 0.45; 26 mm, 7.72 ± 0.48; 29 mm, 8.65 ± 2.01), and elliptical (20 mm, 3.30 ± 0.38; 23 mm, 6.13 ± 0.94; 26 mm, 6.77 ± 1.22; 29 mm, 8.72 ± 0.24) THVs were excellent at 200 million cycles., Conclusions: Nominal SAPIEN 3 THVs demonstrated excellent durability, to an equivalent of 25-years wear. THV durability was similar to the comparator surgical valves tested. Non-nominal (overexpansion, underexpansion, and elliptical) THV deployments also had excellent durability to an equivalent of 5 years wear., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: Although transcatheter aortic valve implantation (TAVI) is officially indicated for severe aortic stenosis (AS) patients at intermediate or higher surgical risk, the procedure is now increasingly being performed in patients who are at low surgical risk. Data on the benefit of TAVI in this patient population are limited. We therefore aimed to perform an updated meta-analysis of all published randomised controlled trials (RCTs) and propensity score-matched studies comparing TAVI versus surgical aortic valve replacement (SAVR) in patients at low surgical risk., Methods and Results: We conducted a systematic review and meta-analysis of RCTs and observational studies with propensity score matching (PSM) of TAVI versus SAVR in patients who are at low surgical risk (mean STS score <4% and/or logistic EuroSCORE <10%). The primary outcome was mortality (examined at 30 days, one year and the longest available follow-up). The secondary outcomes included procedural complications. Nine studies (n=6,124) were included. TAVI was associated with a numerically, but not statistically, significant reduced mortality at 30 days (1.45% vs 2.1%, p=0.05), and similar mortality at one year (5.1% vs 5.0%, p=0.74) and a median of two years (10.8% vs 9.8%, p=0.15). For both time points, there was significant heterogeneity between RCT/PSM studies, with the former suggesting survival advantage for TAVI and the latter for SAVR. In terms of periprocedural complications, TAVI was associated with reduced risk for stroke, bleeding and renal failure and an increase in vascular complications and pacemaker implantation., Conclusions: In patients who are at low surgical risk, TAVI seems to be associated with equivalent mortality up to a median follow-up of two years compared to SAVR. More data are required before TAVI can be routinely considered as an alternative to SAVR in low-risk patients.

Background: The SAPIEN 3 (S3) transcatheter heart valve (THV) can be over-expanded beyond its labeled diameter. Overexpansion can be achieved with use of either a compliant or non-compliant balloon. Objective data regarding the ability to over-expand older generation balloon expandable valves are limited. We sought to assess the effects of over-expanding the SAPIEN and SAPIEN XT (Edwards Lifesciences, Irvine, CA) valve beyond labeled size (diameter) through an ex-vivo bench study., Methods and Results: We assessed SAPIEN and SAPIEN XT THVs, sized 23/26 mm and 23/26/29 mm, respectively. The SAPIEN THVs were explanted samples. Valves were expanded to nominal dimensions, and then incrementally overexpanded with balloons sized 1-, 2-, and 3-mm larger than the recommended diameter. When an appropriate sized non-compliant balloon was not available, a compliant balloon was utilized. Valves underwent visual and radiographic assessment of overexpansion. SAPIEN THVs with labeled size of 23 and 26 mm could be incrementally overexpanded to midvalve (MV) diameters of 26.7 and 27.4 mm, respectively. SAPIENT XT THVs with labeled size of 23, 26, and 29 mm could be incrementally overexpanded to MV diameters of 26.8, 28.3, and 28.8 mm, respectively. The desired degree of overexpansion was only achieved with use of non-compliant balloons and not with compliant balloons. The outflow of the SAPIEN and SAPIEN XT had larger diameters than the MV and inflow of the THV., Conclusion: Overexpansion of older generation SAPIEN and SAPIEN XT THVs is possible. Achieving the desired degree of overexpansion was only achieved with use of non-compliant balloons. This has potential implications for the treatment of failed THVs., (© 2019 Wiley Periodicals, Inc.)

Aims: The aim of this study was to evaluate transcatheter aortic valve-in-valve (ViV) implantation performance in rapid deployment (ViVr) vs. conventional (ViVc) surgical heart valves., Methods and Results: A multicentre registry was developed as part of the VIVID international registry. A total of 30 ViVr patients (Perceval, n=24, ATS 3f Enable™, n=5, and the INTUITY, n=1) were evaluated and compared with 2,288 ViVc patients. Propensity score (PS) matching was performed to adjust further for bias. Compared with ViVc, ViVr patients presented twice as early after surgical heart valve (SHV) implantation (55.2±36.1 vs. 118.4±57.7 months, p<0.001), were more commonly female (82.8% vs. 41.3%, p<0.001), and had shorter body stature and reduced body weight (p<0.05 for both) prior to PS. Implantation was successful in all ViVr cases and, compared with ViVc, was associated with equally favourable haemodynamic outcomes (mean gradient: 14.6±8.3 vs. 16.2±8.9 mmHg, p=0.356; regurgitation ≥mild: 3.7% vs. 5.2%, p=0.793). Periprocedural complication rates were similar and low in both groups. There was no coronary obstruction event in any ViVr case; one patient (3.6%) died during one year of follow-up., Conclusions: ViVr appears effective, safe and associated with favourable haemodynamic outcome.

Aims: To compare transcatheter aortic valve replacement TAVR with self-expandable first-generation Medtronic CoreValve with new-generation Evolut R devices in patients with aortic stenosis., Methods: Multiple databases were screened for all available reports directly or indirectly comparing CoreValve vs Evolut R. Primary endpoint was device success. Procedural, functional and clinical outcomes were assessed as well., Results: Ten retrospective series including 12 294 pts. were found. Overall device success rate was 95.5% and was statistically higher in the Evolut R treated patients as compared with CoreValve: 96.6 vs. 94.8%, respectively; RR (risk ratio) 95%CIs (confidence intervals): 1.02 (1.00-1.04); P = 0.01. There were no statistical differences with regard to postoperative mean aortic gradients 8.5 +/- 5.3 vs 7.9 +/- 4.6 with Evolut R and CoreValve. Evolut R valve demonstrated nearly 50% reduction of the risk for moderate-to-severe paravalvilar leak 0.55 (0.39-0.79); P = 0.001; 60% statistically significant lower risk of developing myocardial injury 0.40 (0.22-0.72); P = 0.002 and numerical reductions in the risk of acute kidney injury, vascular complications and bleeding. Together with significantly reduced risk of permanent pacemaker implantation (0.80 [0.67-0.96]; P = 0.02) the above benefits were associated with 40% reduction in the risk of 30-day all-cause mortality with Evolut R as compared to CoreValve: 0.60 (0.37-1.00); P = 0.05., Conclusions: The use of new-generation Evolut R was associated with improved procedural, functional and clinical outcomes compared with the CoreValve device.

Background: Sizing for transcatheter aortic valve implantation in bicuspid aortic valves (BAV) remains controversial., Methods and Results: The aim of the BAVARD (Bicuspid Aortic Valve Anatomy and Relationship With Devices) retrospective registry is to capture the sizing ratios used for transcatheter aortic valve implantation in BAV and analyze the second-generation prostheses geometry postimplantation. About 101 patients with BAV along with available pre- and post-transcatheter aortic valve implantation multidetector computed tomography were compared with 88 tricuspid aortic valves (TAV) patients. Preprocedural multidetector computed tomography diagnosed type 0 and type 1 BAV in, respectively, 12.9% and 86.1 % of BAV. At baseline, the ellipticity index was similar between BAV and TAV patients: 1.2±0.1 versus 1.2±0.1, P=0.09. The mean annular oversizing was, respectively, 1.14±0.04 and 1.04±0.04, P<0.001, in TAV and BAV patients. The mean prosthesis intercommissural distance, ratio was 1.03±0.1. The mean diameter of the prostheses at the annulus matched the mean perimeter-derived diameter of the aortic annulus at baseline with TAV (23.3±2.2 versus 23.6±1.9, P=0.4) and was smaller with BAV (24±2.8 versus 26.8±3.1, P<0.01), confirming 11% underexpansion in BAV. Finally, in situ, prosthesis diameter and ellipticity followed the same pattern, with stable values from the distal edge to 12 mm above, in both groups., Conclusions: Second-generation prostheses similarly reshape the aortic annulus in TAV and BAV. Prostheses keep consistent diameters from distal edge to 12 mm in TAV and BAV. Prosthesis underexpansion is constantly observed in BAV. Annular-based sizing is accurate in BAV with minimal oversizing. The intercommissural distance, 4 mm above the annulus, could be integrated in gray zones., Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03495050.

Transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis in patients at high or prohibitive surgical risk. Nevertheless, long-term clinical and echocardiographic data are still lacking. We carried out an analysis of 560 consecutive patients who underwent TAVI at our institution from 2008 to 2016 to evaluate temporal changes in TAVI characteristics, predictors of 1-year and long-term outcomes, and to compare the performance of the early- and new-generation valve systems. With time, we have adopted lower risk threshold for patient selection and have been using conscious sedation and transfemoral access preferentially (p <0.001 for all). The incidence of greater than mild PVL decreased from 16% to 7.6%, p = 0.029. Within 5 years, 47% of the patients died, the majority (78%) due to noncardiac causes. Independent predictors of 1-year death included periprocedural aspects (i.e., vascular complications, stroke, and PVL), whereas death occurring later than 1 year was solely related to baseline co-morbidities. Transvalvular gradients and residual regurgitation remained nonclinically significant for up to 5 years of follow-up. New-generation valves were associated with less PVL compared with propensity score-matched early-generation valves (p <0.001). In conclusion, TAVI utilization at our institution has progressed to include lower risk patients with transfemoral access becoming applicable in the great majority. Poor long-term survival is attributable to population factors rather than to procedural factors. Intermediate- and long-term hemodynamics are excellent. PVL has diminished significantly with the new-generation valves. Efforts to improve long- and short-term outcomes remain a therapeutic challenge., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objectives: The Evolut-R (Medtronic, Inc) is a transcatheter aortic valve implantation (TAVI) system that was built on the well-established foundation of Medtronic's CoreValve device platform. Although already in extensive clinical utilization, it is unknown if the Evolut-R improves TAVI outcomes. Herein, we compared TAVI outcomes of the Evolut-R and CoreValve devices., Methods: A propensity score 1:1 matching was conducted on 358 Evolut-R patients (n = 75) and CoreValve patients (n = 283). Thirty-day outcomes were compared using Valve Academic Research Consortium (VARC)-2 criteria. A combined 30-day endpoint including all-cause death, stroke, major vascular complication, major bleeding, implantation failure, paravalvular leak (PVL) ≥ moderate, and new pacemaker implantation was also tested., Results: The final study group included 146 patients (73 Evolut-R; 73 CoreValve). Post matching, baseline characteristics were similar between the two groups. Mean patient age was 82 ± 6 years, mean STS score was 5.2 ± 3.8, 72% were female, and 17% were deemed frail. Implantation success reached 99% with Evolut-R and 94% with CoreValve (P=.10). Both groups had low periprocedural stroke/myocardial infarction/mortality rates and there was also no difference in 30-day vascular complications (P=.18), bleeding (P=.37), PVL (P=.24), and new pacemaker (P=.14). The combined outcome rate was 24% with Evolut-R and 37% with CoreValve (P=.10)., Conclusion: This study indicates that the efficacy and safety of the self-expandable second-generation Evolut-R transcatheter valve is at least comparable with the first-generation CoreValve. The observed improved performance in correct positioning of a single valve and the numerically lower chance to suffer a combined TAVI endpoint needs further investigation.

Aims: Transcatheter heart valve (THV) implantation in failed bioprosthetic valves (valve-in-valve [ViV]) offers an alternative therapy for high-risk patients. Elevated post-procedural gradients are a significant limitation of aortic ViV. Our objective was to assess the relationship between depth of implantation and haemodynamics., Methods and Results: Commercially available THVs used for ViV were included in the analysis (CoreValve Evolut, SAPIEN XT and the Portico valve). THVs were implanted in small surgical valves (label size 19 mm) to simulate boundary conditions. Custom-mounted pulse duplicators registered relevant haemodynamic parameters. Twenty-eight experiments were performed (13 CVE, 5 SXT and 10 Portico). Ranges of depth of implantation were: CVE: -1.2 mm to 15.7 mm; SXT: -2.2 mm to 7.5 mm; Portico: 1.4 mm to 12.1 mm. Polynomial regression established a relationship between depth of implantation and valvular mean gradients (CVE: p<0.001; SXT: p=0.01; Portico: p=0.002), as well as with EOA (CVE: p<0.001; SXT: p=0.02; Portico valve: p=0.003). In addition, leaflet coaptation was better in the high implantation experiments for all valves., Conclusions: The current comprehensive bench testing assessment demonstrates the importance of high device position for the attainment of optimal haemodynamics during aortic ViV procedures.