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Background: Raphe-type bicuspid aortic valve (BAV) is a potential hostile scenario in trans-catheter aortic valve replacement (TAVR) due to pronounced calcium burden, possibly associated with tapered valve configuration. Trans-Catheter heart valve (THV) sizing strategy (annular vs. supra-annular) is controversial in this valve subtype., Objectives: To describe the phenotypical characteristics of severe, tapered, raphe-type, BAV stenosis undergoing TAVR and to explore safety and efficacy of modern-generation THVs, analysing the impact of annular and supra-annular sizing strategies on short- and mid-terms outcomes., Methods: This is a retrospective, multicenter registry enrolling consecutive stenotic Sievers type 1 BAV treated with TAVR. Study population was divided into tapered and non-tapered configuration according to MSCT analysis. Matched comparison between annular and supra-annular sizing groups was performed in tapered population., Results: From January 2016 to June 2023, 897 patients were enrolled. Of them, 696 patients displayed a tapered configuration. Of those, 510 received a THV according to annular sizing. After propensity score matching 186 matched pairs were selected. Technical success (96.2 % vs 94.1 %, OR 1.61 [0.61-4.24], p = 0.34), 30-day device success (83.6 % in both groups, OR 1.42 [0.78-2.57], p = 0.25) and 30-day early safety (71.8 % vs 70.5 %, OR 1.07 [0.68-1.68], p = 0.78) were similar between the annular and supra-annular sizing groups; a higher post-TAVR gradient was observed in supra-annular group, although it was only 2 mmHg mean. At mid-term follow-up, the rate of clinical efficacy was 84.7 %., Conclusions: TAVR with modern-generation devices is safe and effective for tapered raphe-type BAV, showing comparable results for annular and supra-annular sizing strategies., Competing Interests: Declaration of competing interest None., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Background: Balloon-expandable valves (BEVs) and self-expanding valves (SEVs) have different features that may impact the outcomes of patients with Sievers type 1 bicuspid aortic valve (BAV) stenosis undergoing transcatheter aortic valve replacement., Objectives: This study sought to compare procedural and clinical outcomes of BEVs and SEVs in Sievers type 1 BAV stenosis., Methods: AD-HOC (Characteristics, Sizing, and Outcomes of Stenotic Raphe-Type Bicuspid Aortic Valves Treated With Transcatheter Device Implantation) is an observational registry enrolling patients with Sievers type 1 BAV stenosis undergoing transcatheter aortic valve replacement with current-generation BEVs and SEVs at 24 international centers. A 1:1 propensity score matching analysis was performed to adjust for baseline imbalances. The primary endpoint was midterm major adverse events, defined as a composite of all-cause death, neurologic events, or hospitalization for heart failure., Results: Among 955 eligible patients, propensity score matching resulted in 301 pairs. At a median follow-up of 1.3 years, BEVs and SEVs had a similar risk of major adverse events (BEV vs SEV: HR: 0.75; 95% CI: 0.49-1.16; P = 0.200). Technical success was similar (OR: 1.38; 95% CI: 0.63-3.04; P = 0.421). At 30 days, BEVs were associated with a lower risk of new permanent pacemaker implantation (OR: 0.42; 95% CI: 0.24-0.72; P = 0.002) and moderate or greater paravalvular regurgitation (OR: 0.16; 95% CI: 0.05-0.48; P = 0.001) but a higher risk of severe patient-prosthesis mismatch (OR: 3.03; 95% CI 1.02-8.95; P = 0.045)., Conclusions: Current-generation BEVs and SEVs proved similar technical success and midterm clinical efficacy in Sievers type 1 BAV stenosis. Compared to SEVs, BEVs were associated with less permanent pacemaker implantation and moderate or greater paravalvular regurgitation but with more severe patient-prosthesis mismatch., Competing Interests: Funding Support and Author Disclosures The 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 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.)

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.)

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.)

Introduction: Transcatheter aortic valve implantation (TAVI) has emerged as a common and effective treatment for patients with severe aortic stenosis. Changes in systemic blood pressure after TAVI have been described, yet their prognostic value is not established. Thus, we aimed to examine the association of the periprocedural changes in systolic blood pressure (SBP) and in pulse pressure on clinical outcomes after the procedure., Methods: A retrospective study of consecutive patients who underwent TAVI procedure in our medical center. We assessed the effect of the periprocedural changes in blood pressure measurements on mortality, acute myocardial infarction, stroke and hospitalizations at 1 year and on the combined outcome of death, myocardial infarction, and stroke 1 year following the procedure., Results: Our cohort included 455 patients (44% males). Of them, 343 patients (75.4%) had raised SBP immediately after the procedure. Patients with raised SBP had a significantly higher rate of the 1-year composite outcome, compared to patients who did not have a raise in SBP following the procedure (43 [13%] vs. 6 [5.4%], respectively, p = 0.033). After adjustment for age and sex, the postprocedural increase in SBP was significantly associated with the composite outcome, with a hazard ratio of 2.42, 95% CI: 1.03-5.7., Conclusion: An immediate increase in SBP after TAVI is associated with worse 1-year clinical cardiovascular outcomes., Competing Interests: The authors have no conflicts of interest to declare., (© 2024 The Author(s). Published by S. Karger AG, Basel.)

Background: There are limited data regarding treatment for failed balloon-expandable transcatheter heart valves (THVs) in redo-transcatheter aortic valve implantation (TAVI)., Aims: We aimed to assess THV performance, neoskirt height and expansion when performing redo-TAVI with the ACURATE platform inside a SAPIEN 3 (S3) compared to redo-TAVI with an S3 in an S3., Methods: Redo-TAVI was performed on the bench using each available size of the S3, the ACURATE neo2 (ACn2) and the next-generation ACURATE Prime XL (AC XL) implanted at 2 different depths within 20 mm/23 mm/26 mm/29 mm S3s serving as the "failed" index THV. Hydrodynamic testing was performed to assess THV function. Multimodality assessment was performed using photography, X-ray, microcomputed tomography (micro-CT), and high-speed videos., Results: The ACURATE in S3 combinations had favourable hydrodynamic performance compared to the S3 in S3 for all size combinations. In the 20 mm S3, redo-TAVI with the ACn2 had lower gradients compared to the S3 (mean gradient 16.3 mmHg for the ACn2 vs 24.7 mmHg for the 20 mm S3 in 20 mm S3). Pinwheeling was less marked for the ACURATE THVs than for the S3s. On micro-CT, the S3s used for redo-TAVI were underexpanded across all sizes. This was also observed for the ACURATE platform, but to a lesser extent., Conclusions: Redo-TAVI with an ACn2/AC XL within an S3 has favourable hydrodynamic performance and less pinwheeling compared to an S3 in S3. This comes at the price of a taller neoskirt.

Background: Stroke and other clinically significant embolic complications are well documented in the early period following transcatheter aortic valve replacement (TAVR). The CAPTIS device is an embolic protection system, designed to provide neurovascular and systemic protection by deflecting debris away from the brain's circulation, capturing the debris and thus avoiding systemic embolisation., Aims: We aimed to study the safety and feasibility study of the CAPTIS complete cerebral and full-body embolic protection system during TAVR., Methods: A first-in-human study investigated the safety, feasibility and debris capturing ability of CAPTIS during TAVR. Patients were followed for 30 days. The primary endpoints were device safety and cerebrovascular events at 72 hours., Results: Twenty patients underwent TAVR using balloon-expandable or self-expanding valve systems. CAPTIS was successfully delivered, positioned, deployed, and retrieved in all cases, and TAVR was successfully completed without device-related complications. No cerebrovascular events were observed. High numbers of debris particles were captured in all patients., Conclusions: The use of the CAPTIS full-body embolic protection system during TAVR was safe, and it captured a substantial number of debris particles. No patient suffered from a cerebrovascular event. A randomised clinical trial is warranted to prove its efficacy.

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.

Periprocedural systemic embolism is a well-documented complication of transcatheter aortic valve replacement (TAVR). Although the most focus was given to cerebral embolism (which remains unpredictable, difficult to prevent, and a source of increased morbidity and mortality after TAVR), coronary embolism remains less investigated and potentially overlooked. This study provides a case series of 3 patients diagnosed with coronary embolism after TAVR in our institution over a 2-year period (3 of 297 cases, 1%) and a systematic literature review (4 studies; 19 case reports). Overall, coronary embolism associated with TAVR is frequently characterized by proximal vessel occlusion causing ST-elevation myocardial infarction and hemodynamic instability with lower mortality in the acute phase as compared with late coronary embolism. However, it often presents with distal vessel occlusion and minor symptoms that may be overlooked in the periprocedural period. In conclusion, we suggest that TAVR-associated coronary embolism has a much higher prevalence than previously documented. Further studies are warranted to properly assess the prevalence and impact of this phenomenon., Competing Interests: Declaration of Competing Interest Dr. Danenberg serves as a clinical proctor for Medtronic and Edwards Lifesciences. The remaining authors have no competing interests to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

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.)

Aortic perforation is a rare complication of transcatheter aortic valve replacement associated with grim outcomes. Tortuous and calcified aortas increase the risk of aortic trauma and perforation. We report a case in which, despite massive thoracic bleeding, avoidance of thoracic aortic surgery resulted in clinical recovery. ( Level of Difficulty: Intermediate. )., Competing Interests: Dr Danenberg serves as a clinical proctor for Medtronic and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2022 Published by Elsevier on behalf of the American College of Cardiology Foundation.)

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 mean age of transcatheter aortic valve implantation (TAVI) patients is steadily decreasing., Aims: The aim of the study was to describe the characteristics, the indications for and the outcomes of TAVI in patients <70 years old., Methods: All patients undergoing TAVI (n=8,626) from the 18 participating centres between January 2007 and June 2020 were stratified by age (70). For patients <70, the indications for TAVI were extracted from Heart Team discussions and the baseline characteristics and mortality were compared between the two groups., Results: Overall, 640 (7.4%) patients were <70 (9.1% during 2018-2020, p<0.001); the mean age was 65.0±2.3 years. The younger patients were more often male, with bicuspid valves or needing valve-in-valve procedures. They had a higher prevalence of lung disease and diabetes. In 80.7% of cases, the Heart Team estimated an increased surgical risk and TAVI was selected, reflected by an STS score >4% in 20.4%. Five-year mortality was similar (29.4 vs 29.8%, HR 0.95, p=0.432) in the <70 and >70 groups. In the <70 group, mortality was higher for those referred for TAVI due to an increased surgical risk compared to those referred for other reasons (31.6 vs 24.5%, HR 1.23, p=0.021). Mortality was similar regardless of the STS stratum in patients judged by the Heart Team to be at increased surgical risk (32.6 vs 30.4%, HR 0.98, p=0.715)., Conclusions: Use of TAVI in patients <70 is becoming more frequent. The main reason for choosing TAVI is due to an increased surgical risk not adequately represented by the STS score. The outcomes for these patients are similar to those for older TAVI patients. Dedicated trials of TAVI/SAVR in younger patients are needed to guide decisions concerning expansion of TAVI indications. ((ClinicalTrials.gov: NCT04031274).

Aims: We aimed to compare the long-term outcomes of patients undergoing percutaneous coronary intervention (PCI) with biodegradable polymer drug-eluting stents (BP-DES) versus durable polymer drug-eluting stents (DP-DES)., Methods and Results: Among 11 517 PCIs with second-generation DES performed in our institution between 2007 and 2019, we identified 8042 procedures performed using DP-DES and 3475 using BP-DES. The primary outcome was target lesion failure, the composite target lesion revascularization (TLR), target vessel myocardial infarction and death. Propensity score matching was used to create a well-balanced cohort. Mean follow-up was 4.8 years. Of the 3413 matched pairs, 21% were females, and the mean age was 66 years. At 1 year, the primary outcome occurred in 8.3% patients versus 7.1% (P = 0.07), and TLR rate was 3% versus 2% (P = 0.006) in patients with DP-DES and BP-DES respectively. Within 5 years, the primary outcome occurred in 23.1% versus 23.4% (P = 0.44), and the rate of TLR was 7.2% versus 6.5% (P = 0.07) in patients with DP-DES and BP-DES, respectively., Conclusion: Similar rates of the composite outcome were observed throughout the entire follow-up. Target lesion revascularization rates were lower in the BP-DES group at 1-year but equalized within 5 years., (Copyright © 2021 Wolters Kluwer Health, 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 the use and outcomes of percutaneous mechanical circulatory support (pMCS) utilized during transcatheter aortic valve implantation (TAVI) from high-volume centers., Methods and Results: Our international multicenter registry including 13 high-volume TAVI centers with 87 patients (76.5 ± 11.8 years, 63.2% men) who underwent TAVI for severe aortic stenosis and required pMCS (75.9% VA-ECMO, 19.5% Impella CP, 4.6% TandemHeart) during the procedure (prior to TAVI 39.1%, emergent rescue 50.6%, following TAVI 10.3%). The procedures were considered high-risk, with 50.6% having severe left ventricular dysfunction, 24.1% biventricular dysfunction, and 32.2% severe pulmonary hypertension. In-hospital and 1-year mortality were 27.5% and 49.4%, respectively. Patients with prophylactic hemodynamic support had lower periprocedural mortality compared to patients with rescue insertion of pMCS (log rank = 0.013) and patients who did not undergo cardiopulmonary resuscitation during the TAVI procedure had better short and long term survival (log rank <0.001 and 0.015, respectively)., Conclusions: Given the overall survival rate and low frequency of pMCS-related complications, our study results support the use of pMCS prophylactically or during the course of TAVI (bailout) in order to improve clinical outcomes in high-risk procedures or in case of acute life-threatening hemodynamic collapse., (© 2021 Wiley Periodicals LLC.)

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.)

The Valve-in-Valve (ViV) technique is an established alternative for the treatment of structural bioprosthetic valve deterioration (SVD). Data describing the intermediate term follow up of patients treated with this approach is scarce. We report on our intermediate-term outcomes of patients with SVD in the Aortic position treated with ViV. Included were patients with symptomatic SVD in the aortic position valve who were treated by Valve in valve transcatheter aortic valve implantation (ViV-TAVI) during the years 2010-2019 in our center. Three main outcomes were examined during the follow up period: NYHA functional class, ViV-TAVI hemodynamic per echocardiography, and mortality. Our cohort consisted of 85 patients (mean age 78.8 ± 8.9 years). The indications for aortic ViV were: SVD isolated aortic stenosis in 37.6%, SVD isolated aortic regurgitation in 42.2% and combined valve pathology in 20.0%. Self-expandable and balloon-expandable devices were used in 73 (85.9%) and 12 (14.1%), respectively. Average follow up was 3.7 ± 2.4 years. 95 and 91% of patients were in NYHA functional class I/II at 1 and 5 year follow up respectively. At one year, the mean trans-aortic valve pressure was 15 ± 9 mmHg and rates of ≥ moderate aortic regurgitation were 3.7%. Mortality at one year was 8.6% (95% CI 2.3-14.4) and 31% (95% CI 16.5-42.5) at 5 years. ViV in the aortic position offers an effective and durable treatment option for patient with SVD, with low rates of all-cause mortality, excellent hemodynamic and improved functional capacity at intermediate follow up., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Schamroth Pravda, Kornowski, Levi, Witberg, Landes, Perl, Shapira, Orvin, Mishaev, Talmor Barkan, Hamdan, Sharoni, Vaknin Assa and Codner.)

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

Importance: Transcatheter aortic valve replacement (TAVR) failure is often managed by an urgent implantation of a supplementary valve during the procedure (2-valve TAVR [2V-TAVR]). Little is known about the factors associated with or sequelae of 2V-TAVR., Objective: To examine the incidence, causes, and outcomes of 2V-TAVR., Design, Setting, and Participants: A retrospective cohort study was performed using data from an international registry of 21 298 TAVR procedures performed from January 1, 2014, through February 28, 2019. Among the 21 298 patients undergoing TAVR, 223 patients (1.0%) undergoing 2V-TAVR were identified. Patient-level data were available for all the patients undergoing 2V-TAVR and for 12 052 patients (56.6%) undergoing 1V-TAVR. After excluding patients with missing 30-day follow-up or data inconsistencies, 213 2V-TAVR and 10 010 1V-TAVR patients were studied. The 2V-TAVR patients were compared against control TAVR patients undergoing a 1-valve TAVR (1V-TAVR) using 1:4 17 propensity score matching. Final analysis included 1065 (213:852) patients., Exposures: Urgent implantation of a supplementary valve during TAVR., Main Outcomes and Measures: Mortality at 30 days and 1 year., Results: The 213 patients undergoing 2V-TAVR had similar age (mean [SD], 81.3 [0.5] years) and sex (110 [51.6%] female) as the 10 010 patients undergoing 1V-TAVR (mean [SD] age, 81.2 [0.5] years; 110 [51.6%] female). The 2V-TAVR incidence decreased from 2.9% in 2014 to 1.0% in 2018 and was similar between repositionable and nonrepositionable valves. Bicuspid aortic valve (odds ratio [OR], 2.20; 95% CI, 1.17-4.15; P = .02), aortic regurgitation of moderate or greater severity (OR, 2.02; 95% CI, 1.49-2.73; P < .001), atrial fibrillation (OR, 1.43; 95% CI, 1.07-1.93; P = .02), alternative access (OR, 2.59; 95% CI, 1.72-3.89; P < .001), early-generation valve (OR, 2.32; 95% CI, 1.69-3.19; P < .001), and self-expandable valve (OR, 1.69; 95% CI, 1.17-2.43; P = .004) were associated with higher 2V-TAVR risk. In 165 patients (80%), the supplementary valve was implanted because of residual aortic regurgitation after primary valve malposition (94 [46.4%] too high and 71 [34.2%] too low). In the matched 2V-TAVR vs 1V-TAVR cohorts, the rate of device success was 147 (70.4%) vs 783 (92.2%) (P < .001), the rate of coronary obstruction was 5 (2.3%) vs 3 (0.4%) (P = .10), stroke rate was 9 (4.6%) vs 13 (1.6%) (P = .09), major bleeding rates were 25 (11.8%) vs 46 (5.5%) (P = .03) and annular rupture rate was 7 (3.3%) vs 3 (0.4%) (P = .03). The hazard ratios for mortality were 2.58 (95% CI, 1.04-6.45; P = .04) at 30 days, 1.45 (95% CI, 0.84-2.51; P = .18) at 1 year, and 1.20 (95% CI, 0.77-1.88; P = .42) at 2 years. Nontransfemoral access and certain periprocedural complications were independently associated with higher risk of death 1 year after 2V-TAVR., Conclusions and Relevance: In this cohort study, valve malposition was the most common indication for 2V-TAVR. Incidence decreased over time and was low overall, although patients with a bicuspid or regurgitant aortic valve, nontransfemoral access, and early-generation or self-expandable valve were at higher risk. These findings suggest that compared with 1V-TAVR, 2V-TAVR is associated with high burden of complications and mortality at 30 days but not at 1 year.