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Background: The role of percutaneous coronary intervention (PCI) in patients with stable coronary artery disease (CAD) who subsequently undergo transcatheter aortic valve replacement (TAVR) remains uncertain. Therefore, we conducted this study to assess the association of PCI before TAVR with mortality and cardiovascular outcomes., Methods: We used the TriNetX database (Jan 2012 - Aug 2022) and grouped patients into PCI (3 months or less) before TAVR and no PCI. We performed propensity score matched (PSM) analyses for outcomes at 30 days and 1 year., Results: Of 17,120 patients undergoing TAVR, 2322 (14 %) had PCI, and 14,798 (86 %) did not have PCI before TAVR. In the PSM cohort (2026 patients in each group), PCI was not associated with lower all-cause mortality at 30 days (HR: 1.25, 95 % CI: 0.82-1.90) or 1 year (HR: 1.02, 95 % CI: 0.83-1.24). Frequency of repeat PCI after TAVR was low in both no PCI vs. PCI (2.4 % vs. 1.2 %) at 1 year; PCI was associated with a lower rate of repeat PCI (HR: 0.49, 95 % CI: 0.30-0.80). Sensitivity analysis revealed an E-value of 3.5 for repeat PCI (E-value for lower CI for HR: 1.81). PCI was not linked to reductions in MI, heart failure exacerbation, all-cause hospitalization, major bleeding, or permanent pacemaker/implantable cardioverter defibrillator., Conclusion: This analysis showed that PCI prior to TAVR was not associated with improvement in all-cause mortality. However, PCI was associated with a reduced rate of repeat PCI at 1 year., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: SAPIEN3 (S3) is a ubiquitous redo-transcatheter aortic valve (TAV) replacement alternative for degenerated Evolut valves, but S3 sizing for S3-in-Evolut remains unclear. We sought to compare the impact of in vivo computed tomography (CT)-sizing on redo-TAV feasibility for S3-in-Evolut with traditional bench-sizing., Methods: CT scans of 290 patients treated using Evolut R/PRO/PRO+ between July 2015 and December 2021 were analyzed. S3-in-Evolut was simulated using S3 outflow/neoskirt plane (NSP) at node-6, -5, and -4. CT-sizing for S3 was determined by averaging 4 areas of the Evolut stent frame at NSP level and 3 nodes below. Redo-TAV was deemed feasible if the NSP was below the coronaries, or the narrowest valve (virtual S3)-to-aorta distance was >4 mm. Risk of prosthesis-patient mismatch was estimated using predicted indexed-effective orifice area., Results: Compared with bench-sizing, CT-sizing yielded smaller S3 size in 82% at node-6, 81% at node-5, and 84% at node-4. Factors associated with CT-sizing less than bench-sizing were larger index Evolut size, underexpansion of index Evolut, and shallower implant depth (all P <0.05). CT-sizing increased redo-TAV feasibility by +8% at node-6, +10% at node-5, and +4% at node-4. Redo-TAV feasibility increased with annulus size, sinotubular junction dimensions, coronary heights, index Evolut size, deeper Evolut implant depth, and lower NSP levels (all P <0.05). CT-sizing had a slightly higher estimated risk of severe prosthesis-patient mismatch (9% at node-6, 7% at node-5, and 6% at node-4), which could be mitigated by changing the NSP., Conclusions: CT-sizing for S3-in-Evolut is associated with higher feasibility of redo-TAV compared with bench-sizing, potentially reducing the risk of excessive oversizing and S3 underexpansion. Further validation using real-world clinical data is necessary., Competing Interests: Dr Bapat has received consulting fees from Abbott Structural, Medtronic, Boston Scientific, Edwards Lifesciences. Dr Cavalcante has received consulting fees from 4C, Abbott Structural, Anteris, AriaCV, Boston Scientific, Edwards Lifesciences, HighLife, Medtronic, VDyne, WL Gore, Xylocor; has received research grant support from Abbott Northwestern Hospital Foundation; Dr Sorajja has received consulting fees from 4C Medical, Abbott Structural, Adona, Boston Scientific, Edwards Lifesciences, Evolution Medical, Foldax, GE Medical, Laza, Medtronic, Phillips, WL Gore, vDyne, xDot; has received institutional research grant support from Abbott Structural, Edwards Lifesciences, Medtronic and Boston Scientific. The other authors report no conflicts.

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 and Aims: Surgical explantation of transcatheter heart valves (THVs) is rapidly increasing, but there are limited data on patients with THV-associated infective endocarditis (IE). This study aims to assess the outcomes of patients undergoing THV explant for IE., Methods: All patients who underwent THV explant between 2011 and 2022 from 44 sites in the EXPLANT-TAVR registry were identified. Patients with IE as the reason for THV explant were compared to those with other mechanisms of bioprosthetic valve dysfunction (BVD)., Results: A total of 372 patients from the EXPLANT-TAVR registry were included. Among them, 184 (49.5%) patients underwent THV explant due to IE and 188 (50.5%) patients due to BVD. At the index transcatheter aortic valve replacement, patients undergoing THV explant for IE were older (74.3 ± 8.6 vs. 71 ± 10.6 years) and had a lower Society of Thoracic Surgeons risk score [2.6% (1.8-5.0) vs. 3.3% (2.1-5.6), P = .029] compared to patients with BVD. Compared to BVD, IE patients had longer intensive care unit and hospital stays (P < .05) and higher stroke rates at 30 days (8.6% vs. 2.9%, P = .032) and 1 year (16.2% vs. 5.2%, P = .010). Adjusted in-hospital, 30-day, and 1-year mortality was 12.1%, 16.1%, and 33.8%, respectively, for the entire cohort, with no significant differences between groups. Although mortality was numerically higher in IE patients 3 years postsurgery (29.6% for BVD vs. 43.9% for IE), Kaplan-Meier analysis showed no significant differences between groups (P = .16)., Conclusions: In the EXPLANT-TAVR registry, patients undergoing THV explant for IE had higher 30-day and 1-year stroke rates and longer intensive care unit and hospital stays. Moreover, patients undergoing THV explant for IE had a higher 3-year mortality rate, which did not reach statistical significance given the relatively small sample size of this unique cohort and the reduced number of events., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Purpose of Review: This review explores the epidemiology, clinical traits, and diagnosis of Transcatheter Aortic Valve Replacement-Associated Infective Endocarditis (TAVR-IE) and mitral transcatheter edge-to-edge repair infective endocarditis (TEER-IE), focusing on a multimodal imaging approach. It addresses the rising prevalence of TAVR and TEER, emphasizing the need to understand long-term complications and clinical consequences, which poses significant challenges despite advancements in valve technology., Recent Findings: Studies report a variable incidence of TAVR-IE and TEER-IE influenced by diverse patient risk profiles and procedural factors. Younger age, male gender, and certain comorbidities emerge as patient-related risk factors. Procedure-related factors include intervention location, valve type, and technical aspects. Microbiologically, Staphylococcus aureus, Viridans Group Streptococcus, and Enterococcus are frequently encountered pathogens. TAVR-IE and TEER-IE diagnosis involves a multimodal imaging approach due to limitations in echocardiography. Blood cultures and imaging aid identification, with Fluorescence in situ hybridization is showing promise. Treatment encompasses medical management with antibiotics and, when necessary, surgical intervention. The management approach requires a multidisciplinary "Endocarditis Team." This review underscores the need for continued research to refine risk prediction, enhance diagnostic accuracy, and optimize management strategies for TAVR-IE, considering the evolving landscape of transcatheter interventions., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: There are limited data on the impact of transcatheter heart valve (THV) type on the outcomes of surgical explantation after THV failure., Aims: We sought to determine the outcomes of transcatheter aortic valve replacement (TAVR) explantation for failed balloon-expandable valves (BEV) versus self-expanding valves (SEV)., Methods: From November 2009 to February 2022, 401 patients across 42 centres in the EXPLANT-TAVR registry underwent TAVR explantation during a separate admission from the initial TAVR. Mechanically expandable valves (N=10, 2.5%) were excluded. The outcomes of TAVR explantation were compared for 202 (51.7%) failed BEV and 189 (48.3%) failed SEV., Results: Among 391 patients analysed (mean age: 73.0±9.8 years; 33.8% female), the median time from index TAVR to TAVR explantation was 13.3 months (interquartile range 5.1-34.8), with no differences between groups. Indications for TAVR explantation included endocarditis (36.0% failed SEV vs 55.4% failed BEV; p<0.001), paravalvular leak (21.2% vs 11.9%; p=0.014), structural valve deterioration (30.2% vs 21.8%; p=0.065) and prosthesis-patient mismatch (8.5% vs 10.4%; p=0.61). The SEV group trended fewer urgent/emergency surgeries (52.0% vs 62.3%; p=0.057) and more root replacement (15.3% vs 7.4%; p=0.016). Concomitant cardiac procedures were performed in 57.8% of patients, including coronary artery bypass graft (24.8%), and mitral (38.9%) and tricuspid (14.6%) valve surgery, with no differences between groups. In-hospital, 30-day, and 1-year mortality and stroke rates were similar between groups (allp>0.05), with no differences in cumulative mortality at 3 years (log-rank p=0.95). On multivariable analysis, concomitant mitral surgery was an independent predictor of 1-year mortality after BEV explant (hazard ratio [HR] 2.00, 95% confidence interval [CI]: 1.07-3.72) and SEV explant (HR 2.00, 95% CI: 1.08-3.69)., Conclusions: In the EXPLANT-TAVR global registry, BEV and SEV groups had different indications for surgical explantation, with more root replacements in SEV failure, but no differences in midterm mortality and morbidities. Further refinement of TAVR explantation techniques are important to improving outcomes.

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.

Competing Interests: Declaration of Competing Interest Sachin S. Goel is on the Speaker's Bureau for Abbott Structural Heart and is a consultant for Medtronic and W.L. Gore & Associates. The other authors have no competing interests to declare.

Background: The latest-generation Evolut FX TAVR system (Medtronic) offers several potential design improvements over its predecessors, but early reported experience has been limited., Objectives: This study sought to report our multicenter, limited market release, first-in-human experience of transcatheter aortic valve replacement (TAVR) with the Evolut FX system and compare it with a single-center PRO+ (Medtronic) experience., Methods: From June 27 to September 16, 2022, 226 consecutive patients from 9 US centers underwent transfemoral TAVR with the Evolut FX system for native aortic stenosis (89.4%) or prosthetic valve degeneration (10.6%). Commissural alignment was defined as 0° to 30° between native and FX commissures. Patient, anatomical, and procedural characteristics were retrospectively reviewed, and 30-day clinical and echocardiographic outcomes per Valve Academic Research Consortium-3 definitions were reported., Results: Of 226 patients, 34.1% were low risk, 4% had a bicuspid valve, and 11.5% had a horizontal root (≥60°). Direct Inline sheath (Medtronic) was used in 67.6% and Lunderquist stiff wire (Cook Medical) in 35.4% of cases. Optimal hat marker orientation during deployment was achieved in 98.4%, with commissural alignment in 96.5%. At 30 days, 14.3% mild, 0.9% moderate, and no severe paravalvular leak were observed. Compared with the Evolut PRO+ experience from 1 center, FX had a more symmetrical implantation with shallower depth at the left coronary cusp (P < 0.001), fewer device recaptures (26.1% vs 39.5%; P = 0.004), and improved commissural alignment (96.5% vs 80.2%; P < 0.001)., Conclusions: The Evolut FX system demonstrated favorable 30-day outcomes with a significant improvement over PRO+ in achieving commissural alignment, fewer device recaptures, and more symmetrical implantation. These features may benefit younger patients undergoing TAVR with the supra-annular, self-expanding valve, where lifetime management would be important., Competing Interests: Funding Support and Author Disclosures Dr Attizzani is a consultant for Medtronic and Abbott Vascular; and serves as a proctor and is on the advisory board for Medtronic. Dr Chetcuti has received personal fees from Medtronic for proctoring and consulting; institutional grants from Edwards Lifesciences, Boston Scientific, and Jena during the conduct of the study; and serves on advisory boards for JenaValve without remuneration. Dr Fukuhara is a consultant for Medtronic, Terumo Aortic, and Artivion. Dr Grossman is a physician proctor for Medtronic; and receives research support from Medtronic, Edwards Lifesciences, Abbott, Cardiovascular Systems, Inc., and Boston Scientific. Dr Goel is a consultant for Medtronic and W. L. Gore & Associates; and is on the Speakers Bureau for Abbott Structural Heart. Dr Kleiman is a local principal investigator in trials sponsored by Boston Scientific, Medtronic, Abbott, and Edwards Lifesciences. Dr Puri is a speaker and proctor for Medtronic; is a consultant for Medtronic, Centerline Biomedical, Boston Scientific, Abbott, Philips, Products & Features, Shockwave Medical, VDyne, VahatiCor, Advanced Nanotherapies, NuevoSono, TherOx, GE Healthcare, BioVentrix, and Protembis; and has equity interest in Centerline Biomedical, VahatiCor, and NuevoSono. Dr Byrne is a physician proctor for Abbott Structural Heart and Medtronic; a consultant for Medtronic and Abiomed; and has received speakers honoraria from Abbott Structural Heart and Abiomed. Dr Grubb is a physician proctor for Medtronic and Edwards Lifesciences; and has served as a consultant for Medtronic, Boston Scientific, Ancora, HLT, BioVentrics, 4C Medical, W.L. Gore, and Abbott Vascular. Dr Herrmann has received institutional research funding from Boston Scientific, Abbott Structural Heart, Edwards Lifesciences, and Medtronic; and has received consultant fees and speaking honoraria from Medtronic. Dr Ramlawi is a consultant for Boston Scientific, Medtronic, Liva Nova, and Atricure. Dr Khera is a speaker for Medtronic and Zoll Medical; a proctor for Medtronic; and a consultant for Terumo, Medtronic, Abbott, and Boston Scientific. Dr Reardon is a consultant for Medtronic, Boston Scientific, Abbott, and W. L. Gore & Associates. Dr Tang is a physician proctor for Medtronic; a consultant for Medtronic, Abbott Structural Heart, and NeoChord; a physician advisory board member for Abbott Structural Heart, Boston Scientific, and JenaValve; and receives speakers honoraria from Siemens Healthineers and East End Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Over the last 20 years, transcatheter aortic valve replacement (TAVR) has revolutionized the management of aortic stenosis and has become the standard of care across the entire spectrum of surgical risk. Expansion of TAVR in treating younger, lower-risk patients with longer life expectancies, and treating earlier in the disease process, has seen a continuous evolution in device technology, with several next-generation transcatheter heart valves developed to minimize procedural complications and improve patient outcomes. This review provides an update on the latest advances in transcatheter delivery systems, devices, and leaflet technology., Competing Interests: Dr. Tang is a physician proctor for Medtronic, a consultant for Medtronic, Abbott, and NeoChord, a physician advisory board member for Abbott and JenaValve, and receives speakers honoraria from Siemens Healthineers and East End Medical. Dr. Kleiman is a local principal investigator in trials sponsored by Boston Scientific, Medtronic, Abbott, and Edwards Lifesciences. Dr. Reardon is a consultant for Medtronic, Boston Scientific, Abbott, and W. L. Gore & Associates. The other authors have no competing interests to declare., (Copyright: © 2023 The Author(s).)

Background: The relationship of body mass index (BMI) and an "obesity paradox" with cardiovascular risk prediction is controversial. This systematic review and meta-analysis aims to compare the associations of different BMI ranges on transcatheter aortic valve implantation (TAVI) outcomes., Methods: International databases, including PubMed, the Web of Science, and the Cochrane Library, were systematically searched for observational and randomized controlled trial studies investigating TAVI outcomes in any of the four BMI categories: underweight, normal weight, overweight, and obese with one of the predefined outcomes. Primary outcomes were in-hospital, 30-day, and long-term all-cause mortality. Random-effects meta-analysis was performed to calculate the odds ratio (OR) or standardized mean differences (SMD) with 95% confidence interval (CI) for each paired comparison between two of the BMI categories., Results: A total of 38 studies were included in our analysis, investigating 99,829 patients undergoing TAVI. There was a trend toward higher comorbidities such as hypertension, diabetes, and dyslipidemia in overweight patients and individuals with obesity. Compared with normal-weight, patients with obesity had a lower rate of 30-day mortality (OR 0.42, 95% CI 0.25-0.72, p < 0.01), paravalvular aortic regurgitation (OR 0.63, 95% CI 0.44-0.91, p = 0.01), 1-year mortality (OR 0.48, 95% CI 0.24-0.96, p = 0.04), and long-term mortality (OR 0.69, 95% CI 0.51-0.94, p = 0.02). However, acute kidney injury (OR 1.16, 95% CI 1.04-1.30, p = 0.01) and permanent pacemaker implantation (OR 1.25, 95% CI 1.05-1.50, p = 0.01) odds were higher in patients with obesity. Noteworthy, major vascular complications were significantly higher in underweight patients in comparison with normal weight cases (OR 1.62, 95% CI 1.07-2.46, p = 0.02). In terms of left ventricular ejection fraction (LVEF), patients with obesity had higher post-operative LVEF compared to normal-weight individuals (SMD 0.12, 95% CI 0.02-0.22, p = 0.02)., Conclusion: Our results suggest the presence of the "obesity paradox" in TAVI outcomes with higher BMI ranges being associated with lower short- and long-term mortality. BMI can be utilized for risk prediction of patients undergoing TAVI., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Paravalvular regurgitation (PVR) may be missed intraoperatively with transthoracic echocardiography (TTE) guided minimalist TAVR. We sought to determine the incidence and echocardiographic distribution of PVR missed on intra-op TTE, but detected on predischarge TTE., Methods: From July 2015 to 2020, 475 patients with symptomatic severe native aortic stenosis underwent TTE-guided minimalist TAVR. Missed PVR was defined as predischarge PVR that was ≥1 grade higher than the corresponding intra-op PVR severity. PVR was classified as anterior or posterior on the four standard TTE views; parasternal short-axis (PSAX), parasternal long-axis (PLAX), apical 3-chamber (A3C), and 5-chamber (A5C). Location-specific risk of missed PVR was then determined., Results: Mild or greater PVR was seen in 55 (11.5%) cases intra-op and 91 (19.1%) at predischarge, with no severe PVR. Among the 91 patients with ≥mild predischarge PVR, missed PVR was present in 42 (46.2%). Compared to the corresponding anterior jets, missed PVR rate was significantly higher for posterior jets in PLAX (62.5% vs. 25.0%, p = 0.005), A5C (56.9% vs. 25.0%, p = 0.009), PSAX (66.7% vs. 24.3%, 0.001), but not A3C (58.5% vs. 40.0%, p = 0.28)., Conclusions: Intraoperative TTE-guided minimalist TAVR either misses nearly half of ≥mild PVR or underestimates PVR by ≥1 grade when compared to predischarge TTE. Posterior PVR jets are more likely to be missed. Transesophageal echo guidance may help minimize missing PVR. Further studies are warranted., (© 2022 Wiley Periodicals LLC.)

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.)

Given the expanding indications of transcatheter aortic valve replacement (TAVR) in younger patients with longer life expectancies, the ability to perform postprocedural coronary access represents a priority in their lifetime management. A growing body of evidence suggests that commissural (and perhaps coronary) alignment in TAVR impacts coronary access and valve hemodynamics as well as coronary flow and access after redo-TAVR. Recent studies have provided modified delivery system insertion and rotation techniques to obtain commissural alignment with available transcatheter heart valve devices. Moreover, patient-specific preprocedural planning and postprocedural imaging tools have been developed to facilitate and evaluate commissural alignment. Future efforts should aim to refine transcatheter heart valve and delivery system designs to make neocommissural alignment easier and more reproducible. The aim of this review is to present an in-depth insight of commissural alignment in TAVR, including its rationale, standardized definitions, technical steps, outcomes, and future directions., Competing Interests: Funding Support and Author Disclosures Dr Tang is a physician proctor and consultant for Medtronic; a consultant and physician advisory board member for Abbott Structural Heart; and a physician advisory board member for JenaValve. Dr Amat-Santos is a physician proctor and consultant for Medtronic, Boston Scientific, and Meril Life. Dr De Backer has received institutional research grants and consulting fees from Abbott and Boston Scientific. Dr Barbanti is a consultant for Edwards Lifesciences, Boston Scientifics, and Medtronic. Dr Tchétché has received honoraria or consultation fees from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Kim is a proctor and has received personal fees from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, Meril Life Sciences, and Shockwave Med. Dr Tarantini has received lecture fees from Medtronic, Edwards Lifesciences, Abbott, and Boston Scientific. Dr Søndergaard has received consultant fees and/or institutional research grants from Abbott, Boston Scientific, Medtronic, and SMT. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2022 by the American College of Cardiology Foundation. Published by Elsevier.)

Objectives: To compare outcomes in Sapien 3 Ultra (S3U) transcatheter aortic valve replacement (TAVR) with extreme annular undersizing (EAU) versus nominal annular sizing (NAS)., Background: The Edwards S3U valve has reduced paravalvular leak (PVL) in TAVR but outcomes remain unknown in extremely undersized anatomy. Implanting a smaller S3U valve may facilitate future redo-TAVR but risk compromising hemodynamics., Methods: From December 2019 to July 2021, 366 patients with native aortic stenosis underwent S3U TAVR. Patients with EAU (annular areas >430 mm 2 for 23 mm or >546 mm 2 for 26 mm) were compared to NAS (338-430 mm 2 for 23 mm or 430-546 mm 2 for 26 mm). In-hospital and 30-day outcomes, and redo-TAVR feasibility were determined., Results: There were 79 (21.6%) EAU patients, with more bicuspid (p = 0.0014) and ≥moderate annular/left ventricular outflow tract calcification (p < 0.001). The EAU group had less annular oversizing than NAS group (23 mm: -8.2 ± 2.6% vs. 4.0 ± 7.0%, p < 0.001; 26 mm: -8.9 ± 2.2% vs. 6.7 ± 6.9%, p < 0.001), more balloon overfilling (71.3% vs. 11.6%, p < 0.001), and postdilatation (15.0% vs. 5.8%, p = 0.016). No differences were found in in-hospital or 30-day mortality and stroke (p > 0.05). Mild PVL (13.4% EAU vs. 11.5% NAS, p = 0.56) and mean gradients (23 mm: 13.0 ± 4.5 vs. 14.1 ± 5.4 mmHg, p = 0.40; 26 mm: 11.4 ± 4.1 vs. 11.5 ± 3.9 mmHg, p = 1.0) were similar at 30 days. Had the EAU group undergone NAS with the larger Sapien 3/S3U, by computed tomography analysis simulating 80:20 or 90:10 target implant depth, 33.3%-60.9% (vs. 4.3%-23.2%) would not be feasible for redo-TAVR due to high risk of coronary obstruction., Conclusions: In this first report of EAU with S3U TAVR, similar excellent short-term outcomes can be achieved compared to NAS, and may preserve future redo-TAVR option., (© 2022 Wiley Periodicals LLC.)

Background: It is controversial that cerebral embolic protection devices (CEPDs) reduce clinical stroke during transcatheter aortic valve replacement (TAVR). Herein, we investigated the impact of CEPDs on in-hospital clinical stroke using a nationally representative sample., Methods and Results: Using the National Inpatient Sample (NIS) database, 109,240 patients who underwent TAVR between 2017 and 2018 were included. They were categorized into 2 groups according to usage of CEPDs; the CEPD and non-CEPD groups. After propensity score matching, 3805 pairs were acquired. Our main outcome was in-hospital clinical stroke. Other outcomes were in-hospital mortality, acute kidney injury (AKI), AKI leading to hemodialysis, bleeding requiring transfusion, overall bleeding complications, infectious complications, length of stay, and total cost. In-hospital clinical stroke did not significantly differ between the 2 groups (0.7% versus 1.1%, p = 0.449). The CEPD group was associated with a significantly lower in-hospital mortality (0.5% versus 1.4%, p = 0.029) and reduced total cost ($49,047 ± 19,666 versus $50,051 ± 23,190, p < 0.001), compared with the non-CEPD group, whereas there were no significant differences in the other outcomes., Conclusions: By using the NIS database with a large number of cases, TAVR with CEPDs was not associated with a lower incidence of in-hospital clinical stroke compared with no use of CEPDs after matching., Competing Interests: Declaration of competing interest Dr. Tang is a physician proctor for Edwards Lifesciences and Medtronic; and is a consultant for Medtronic. The other authors have no conflicts of interest to declare., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: We assessed the impact of conventional delivery system (DS) insertion technique on "Hat-marker" orientation/commissural alignment in patients who underwent transcatheter aortic valve replacement (TAVR) in the Evolut Low Risk Trial CT substudy versus a modified technique., Background: Unlike surgical aortic valve replacement, where alignment of the surgical valve commissures with native commissures can be achieved virtually 100% of the time, commissural alignment during TAVR is not achieved consistently. This may subsequently impact the feasibility of both coronary access and reintervention after TAVR., Methods: "Hat-marker" orientations during deployment were characterized as outer curve (OC), center front (CF), inner curve, and center back. Severe commissure-to-CA overlap was 0-20°. "Hat-marker" orientations and CA overlap were compared to 240 patients from a single center using the modified 3-o'clock flush port DS technique., Results: In the CT substudy in which conventional DS insertion was performed (flush port at 12 o'clock); 154/249 had both analyzable CT and procedural fluoroscopy to validate "Hat-marker" to C-tab/commissural orientation. On post-TAVR CT, Evolut valve commissural orientation and coronary artery (CA) ostia were identified. Compared to conventional DS technique in the CT substudy, the modified technique had higher rates of "Hat-marker" at OC/CF orientation, improved commissural alignment and reduced severe CA overlap; (left main, 14.2 vs. 27.9%; right coronary artery, 11.7 vs. 27.3% both, 5.0 vs. 13.6%; 1 or both CA, 20.8 vs. 41.6%, all p < 0.01)., Conclusions: The modified technique improved initial "Hat-marker" orientation during Evolut deployment and resulted in better commissural alignment and reduced CA overlap., (© 2021 Wiley Periodicals LLC.)

Purpose of Review: Accurate imaging of the aortic root during valve implantation is crucial for proper prosthesis positioning during TAVR. The purpose of this review was to determine if routine use of the cusp-overlap view should be adopted for self-expanding valves., Recent Findings: The use of the cusp-overlap view with the Evolut, Portico, ACURATE neo/neo2, and JenaValve systems is associated with lower post-procedural new permanent pacemaker implantation rates when compared with the standard 3-cusp view, presumably due to more precise valve implantation relative to the conduction system by the non-coronary cusp. By elongating the left ventricular outflow tract and accentuating the right-non commissure in the center of the fluoroscopic view, the cusp-overlap technique allows operators to more precisely control the prosthesis implant depth during self-expanding valve deployment. While the early experience with this approach in Evolut TAVR has been promising, the results of larger studies with longer follow-up across multiple self-expanding systems are warranted., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Objectives: The aim of this study was to evaluate clinical characteristics, mechanisms of failure, and outcomes of transcatheter aortic valve replacement (TAVR) explantation., Background: Surgical explantation following TAVR may be required for structural valve degeneration, paravalvular leak, infection, or other reasons. However, in-depth data on indications and outcomes are lacking., Methods: Data from a multicenter, international registry (EXPLANT-TAVR) of patients who underwent TAVR explantation were reviewed retrospectively. Explantations performed during the same admission as initial TAVR were excluded. Clinical and echocardiographic outcomes were evaluated. Median follow-up duration was 6.7 months (interquartile range [IQR]: 1.0-18.8 months) after TAVR explantation and was 97.7% complete at 30 days and 86.1% complete at 1 year., Results: From November 2009 to September 2020, 269 patients across 42 centers with a mean age of 72.7 ± 10.4 years underwent TAVR explantation. About one quarter (25.9%) were deemed low surgical risk at index TAVR, and median Society of Thoracic Surgeons risk at TAVR explantation was 5.6% (IQR: 3.2%-9.6%). The median time to explantation was 11.5 months (IQR: 4.0-32.4 months). Balloon-expandable and self-expanding or mechanically expandable valves accounted for 50.9% and 49.1%, respectively. Indications for explantation included endocarditis (43.1%), structural valve degeneration (20.1%), paravalvular leak (18.2%), and prosthesis-patient mismatch (10.8%). Redo TAVR was not feasible because of unfavorable anatomy in 26.8% of patients. Urgent or emergency cases were performed in 53.1% of patients, aortic root replacement in 13.4%, and 54.6% had concomitant cardiac procedures. Overall survival at last follow-up was 76.1%. In-hospital, 30-day, and 1-year mortality rates were 11.9%, 13.1%, and 28.5%, respectively, and stroke rates were 5.9%, 8.6%, and 18.7%, respectively., Conclusions: The EXPLANT-TAVR registry reveals that surgical risks associated with TAVR explantation are not negligible and should be taken into consideration in the lifetime management of aortic stenosis., Competing Interests: Funding Support and Author Disclosures Dr Bapat has served as a consultant for Medtronic, Edwards Lifesciences, 4C Medical, and Boston Scientific. Dr Fukuhara is a consultant for Terumo Aortic. Dr Pirelli is a physician proctor for and has received speaker honoraria from Edwards Lifesciences; and is a consultant for Medtronic. Dr Wyler von Ballmoos has served as a consultant for LivaNova, Medtronic, and Boston Scientific. Dr Chu has received speaker honoraria from Medtronic, Edwards Lifesciences, and Terumo Aortic. Dr Rodés-Cabau has received institutional research grants from and is a consultant for Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Borger has reported that his hospital receives speaker honoraria and/or consulting fees on his behalf from Edwards Lifesciences, Medtronic, Abbott, and CryoLife. Dr Lange is a consultant for Medtronic. Dr Hagl has received speaker honoraria from Edwards Lifesciences. Dr Denti has received speaker honoraria from Abbott and Edwards Lifesciences; and is a consultant for InnovHeart. Dr Modine is a physician proctor and consultant for Medtronic, Edwards Lifesciences, and Abbott. 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; is a consultant for Medtronic, Abbott, and NeoChord; and is an advisory board member for Abbott and JenaValve. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Urgent transcatheter aortic valve implantation (TAVI) is a feasible option for aortic stenosis (AS) patients with decompensated heart failure (HF) and cardiogenic shock (CS) as compared to the more traditional urgent balloon aortic valvuloplasty (BAV)., Objectives: We conducted a retrospective analysis to compare risk and cause of readmission in these two high-risk groups., Methods: Nationwide Readmission Database (NRD) 2011-2014 was retrospectively analyzed to identify patients with AS having either urgent TAVI or urgent BAV using appropriate ICD-9 codes. Propensity scores were used to match patients with urgent TAVI as compared to patients with urgent BAV. Statistical analysis was performed using the Stata 15.1 software., Results: We identified a weighted sample of 6,670 patients with urgent BAV and 6,964 patients with urgent TAVI. The all-cause 30- and 90-day readmission was lower in the urgent TAVI group compared to urgent BAV (15.4 vs. 22.5%, (aHR): 0.92 [0.90-0.95] p < .001). 30-day readmission due to CV cause and HF was also lower in the urgent TAVI group (aHR, 0.93: p < .001 and aHR, 0.98: p = .040, respectively). The 30-day gastrointestinal (GI) bleed readmission rate was three times higher in urgent TAVI group (aHR, 3.00:95% CI (1.23-7.33), p = .016), but was not statistically significant at 90-days. Cardiac causes of readmission were the predominant cause of readmission in both groups, but more pronounced in urgent BAV group (60.3 vs. 40.5%, p < .001)., Conclusion: Urgent TAVI appears beneficial in patients with AS and decompensated HF or CS driven by roughly 10 and 25% reductions in overall readmissions at 30 and 90 days, and marked reductions in reintervention, although offset partially by higher risk of readmission due to GI bleeding at 30 days., (© 2021 Wiley Periodicals LLC.)

Background: Currently, 2 third-generation transcatheter valves, 29-mm Sapien-3 and 34-mm Evolut-R (ER), are indicated for large sized aortic annuli. We analyzed short and 1-year performance of these valves in patients with large (area ≥575 mm 2 or perimeter ≥85 mm) and extra-large (≥683 mm 2 or ≥94.2 mm) aortic annuli undergoing transcatheter aortic valve replacement., Methods: A total of 833 patients across 12 centers with symptomatic aortic stenosis and large aortic annuli underwent transcatheter aortic valve replacement with 29-mm Sapien-3 (n=640) or 34-mm ER (n=193). Clinical, anatomic, and procedural characteristics were collected, and Valve Academic Research Consortium-2 outcomes were reported., Results: Median aortic annulus area and perimeter were 617 mm 2 (591-657) and 89.1 mm (87.0-92.1), respectively (704 mm 2 [689-743] and 96.0 mm [94.5-97.9] in the subgroup of 124 patients with extra-large annuli). Overall device success was 94.3% (Sapien-3, 95.8% and ER, 89.3%; P =0.001), with a higher rate of significant paravalvular leak ( P =0.004), second valve implantation ( P =0.013), and valve embolization ( P =0.009) in the ER group. Thirty-day and 1-year mortality was 2.4% and 9.2%, respectively, without differences between groups. Valve hemodynamics were excellent (mean gradient, 8.8±3.6 mm Hg; 3.3% rate of moderate-severe paravalvular leak) in the extra-large annulus, without differences compared with the large annulus group., Conclusions: In patients with large and extra-large aortic annuli, transcatheter aortic valve replacement using 29-mm Sapien-3 and 34-mm ER is safe and feasible. Observed differences in clinical outcomes and hemodynamic performance may guide valve choice in this cohort of patients undergoing transcatheter aortic valve replacement.

With aging population and preponderance of severe aortic stenosis occurring in elderly patients, the number of transcatheter aortic valve implantations (TAVI) performed in the elderly are growing. Frailty is common in the elderly and is known to be associated with worse outcomes. We aimed to evaluate the impact of frailty on hospital readmissions rates after TAVI. We used the 2016 Nationwide Readmission Database and categorized patients who underwent TAVI low, intermediate, and high frailty status. The primary outcome was 6-months readmission rates across the 3 frailty categories. Secondary outcomes included causes of readmissions, in-hospital mortality and cost of care. STATA 16.0 was used for survey-specific statistical tests. Of 20,504 patients who underwent TAVI, 58.9% were low-, 39.6% were intermediate-, and 1.5% were in the high-frailty group. Overall in-hospital mortality was 1.9% (n = 396), and was 0.6%, 3.3%, and 16.8% (p <0.01) with increasing frailty. Of the 20,108 patients who survived to discharge, 6,427 (32%) patients were readmitted within 6-months after TAVI. Readmission rates increased across the categories from 27.9% in low, 37.6% in intermediate and 51.1% in high frailty group (p <0.01). While cardiac causes (mostly heart failure) were the predominant readmission etiologies across frailty categories (low: 51.2%, intermediate: 34.1%, high: 27.2%), rates of infectious and injury-related readmissions increased (low: 11%, intermediate: 30%, high: 45%). Mortality during readmissions also worsened from 0.8%, 5.3%, and 8.5% (p <0.01). Over 40% of patients undergoing TAVI were of intermediate-high frailty. In conclusion, an increasing frailty was associated with significantly worse postprocedure mortality, readmissions, and related mortality., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to evaluate the impact of initial deployment orientation of SAPIEN 3, Evolut, and ACURATE-neo transcatheter heart valves on their final orientation and neocommissural overlap with coronary arteries., Background: Coronary artery access and redo transcatheter aortic valve replacement (TAVR) following initial TAVR may be influenced by transcatheter heart valve orientation. In this study the impact of transcatheter heart valve deployment orientation on commissural alignment was evaluated., Methods: Pre-TAVR computed tomography and procedural fluoroscopy were analyzed in 828 patients who underwent TAVR (483 SAPIEN 3, 245 Evolut, and 100 ACURATE-neo valves) from March 2016 to September 2019 at 5 centers. Coplanar fluoroscopic views were coregistered to pre-TAVR computed tomography to determine commissural alignment. Severe overlap between neocommissural posts and coronary arteries was defined as 0° to 20° apart. The SAPIEN 3 had 1 commissural post crimped at 3, 6, 9, and 12 o'clock. The Evolut "Hat" marker and ACURATE-neo commissural post at deployment were classified as center back (CB), inner curve (IC), outer curve (OC), or center front (CF) and matched with final orientation., Results: Initial SAPIEN 3 crimped orientation had no impact on commissural alignment. Evolut "Hat" at OC or CF at initial deployment had less severe overlap than IC or CB (p < 0.001) against the left main (15.7% vs. 66.0%) and right coronary (7.1% vs. 51.1%) arteries. Tracking Evolut "Hat" at OC of the descending aorta (n = 107) improved OC at deployment from 70.2% to 91.6% (p = 0.002) and reduced coronary artery overlap by 36% to 60% (p < 0.05). ACURATE-neo commissural post at CB or IC during deployment had less coronary artery overlap compared to CF or OC (p < 0.001), with intentional alignment successful in 5 of 7 cases., Conclusions: This is the first systematic evaluation of commissural alignment in TAVR. More than 30% to 50% of cases had overlap with 1 or both coronary arteries. Initial SAPIEN 3 orientation had no impact on alignment, but specific initial orientations of Evolut and ACURATE improved alignment. Optimizing valve alignment to avoid coronary artery overlap will be important in coronary artery access and redo TAVR., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

New persistent left bundle branch block (NP-LBBB) has been associated with adverse outcomes after TAVI but few predictors thus far reported. We sought to identify predictors of NP-LBBB after TAVI with EvolutR/PRO (ER/EP). From 1/2016 to 4/2019, 544 patients from 2 centers underwent TAVI with Evolut (54% ER, 46% EP) for severe native aortic stenosis. Patients with previous LBBB and pacemaker were excluded. Aortic root analysis was performed using 3Mensio Valves Software and membranous septal length (MSL) was determined using the standard coronal view. Clinical, anatomic and procedural characteristics of 396 Evolut were analyzed and predictors of NP-LBBB were identified. Valve Academic Research Consortium-2 outcomes were reported. At discharge, NP-LBBB was seen in 76(19.2%) patients. NP-LBBB in Evolut was associated with implant depth at left coronary cusp (p = 0.004) and 34 mm ER (p = 0.026). Independent predictors of NP-LBBB in Evolut were shorter MSL (odds ratio [OR] = 0.82 per mm septum, 95% confidence interval [CI] = 0.68 to 0.98,p = 0.030), left ventricular outflow tract (LVOT) eccentricity (OR = 1.04 per %, 95% CI = 1.01 to 1.06,p = 0.002), implant depth at noncoronary cusp (NCC) (OR = 1.28 per mm ventricular, 95% CI = 1.11 to 1.48,p = 0.001) and annular perimeter oversizing ≥20% (OR = 2.38, 95% CI = 1.20 to 4.72, p = 0.013). On ROC curve analysis, MSL ≤6.5 mm, NCC depth ≥3 mm and LVOT eccentricity ≥35% were optimal threshold values to predict NP-LBBB. In Conclusion, shorter MSL, LVOT eccentricity, annular oversizing and deeper implant depth are novel predictors of NP-LBBB in Evolut TAVI. Preprocedural CT assessment of aortic root anatomy may help identify patients at risk for NP-LBBB. In such patients, modifying procedural factors such as higher implant and less annular oversizing may reduce the risk of NP-LBBB. Further evaluation of our hypothesis is warranted., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to report the 1-year results of transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli., Background: Favorable 30-day outcomes of S3 TAVR in annuli >683 mm 2 have previously been reported. Pacemaker implantation rates were acceptable, and a larger left ventricular outflow tract and more eccentric annular anatomy were associated with increasing paravalvular leak., Methods: From December 2013 to December 2018, 105 patients across 15 centers with mean area 721.3 ± 36.1 mm 2 (range 683.5 to 852.0 mm 2 ) underwent TAVR using an S3 device. Clinical, anatomic, and procedural characteristics were analyzed. One-year survival and echocardiographic follow-up were reached in 94.3% and 82.1% of patients, respectively. Valve Academic Research Consortium-2 30-day and 1-year outcomes were reported., Results: The mean age was 76.9 ± 10.4 years, and Society of Thoracic Surgeons predicted risk score averaged 5.2 ± 3.4%. One-year overall mortality and stroke rates were 18.2% and 2.4%, respectively. Quality-of-life index improved from baseline to 30 days and at 1 year (p < 0.001 for both). Mild paravalvular aortic regurgitation occurred in 21.7% of patients, while moderate or greater paravalvular aortic regurgitation occurred in 4.3%. Mild and moderate or severe transvalvular aortic regurgitation occurred in 11.6% and 0%, respectively. Valve gradients remained stable at 1 year., Conclusions: S3 TAVR in annular areas >683 mm 2 is feasible, with favorable mid-term outcomes., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to determine factors affecting paravalvular leak (PVL) in transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli., Background: The largest recommended annular area for the 29-mm S3 is 683 mm 2 . However, experience with S3 TAVR in annuli >683 mm 2 has not been widely reported., Methods: From December 2013 to July 2017, 74 patients across 16 centers with mean area 721 ± 38 mm 2 (range: 684 to 852 mm 2 ) underwent S3 TAVR. The transfemoral approach was used in 95%, and 39% were under conscious sedation. Patient, anatomic, and procedural characteristics were retrospectively analyzed. Valve Academic Research Consortium-2 outcomes were reported., Results: Procedural success was 100%, with 2 deaths, 1 stroke, and 2 major vascular complications at 30 days. Post-dilatation occurred in 32%, with final balloon overfilling (1 to 5 ml extra) in 70% of patients. Implantation depth averaged 22.3 ± 12.4% at the noncoronary cusp and 20.7 ± 9.9% at the left coronary cusp. New left bundle branch block occurred in 17%, and 6.3% required new permanent pacemakers. Thirty-day echocardiography showed mild PVL in 22.3%, 6.9% moderate, and none severe. There was no annular rupture or coronary obstruction. Mild or greater PVL was associated with larger maximum annular and left ventricular outflow tract (LVOT) diameters, larger LVOT area and perimeter, LVOT area greater than annular area, and higher annular eccentricity., Conclusions: TAVR with the 29-mm S3 valve beyond the recommended range by overexpansion is safe, with acceptable PVL and pacemaker rates. Larger LVOTs and more eccentric annuli were associated with more PVL. Longer term follow-up will be needed to determine durability of S3 TAVR in this population., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: Paravalvular leak (PVL) remains an important issue in TAVI. The Edwards SAPIEN 3 (S3) valve has reduced PVL but in up to one third of patients mild leak remains. Our study aimed to identify predictors of mild PVL after TAVI with the S3 valve., Methods and Results: From October 2015 to May 2017, 122 consecutive patients underwent S3 TAVI for symptomatic severe aortic stenosis. Thirty-three patients with mild PVL on transthoracic echocardiography at 30-day follow-up were compared to 89 with none/trace PVL. Thirty-day mortality was 2.5% (n=3), with zero stroke and major vascular complications. There were no differences between the two groups in patient characteristics, annular and left ventricular outflow tract (LVOT) sizing, distribution and severity of annular calcification, valve implantation technique, post-dilatation and implant depth. Mild PVL was associated with higher annular eccentricity (p=0.04) and moderate-severe LVOT calcification (p=0.03). Independent predictors of mild PVL were LVOT eccentricity (OR 1.05 per % ellipticity, 95% CI: 1.02-1.09, p=0.005), discordant sizing (OR 3.08, 95% CI: 1.20-7.90, p=0.02) and three-leaflet calcification (OR 13.3, 95% CI: 2.66-66.7, p=0.002)., Conclusions: LVOT eccentricity and discordant sizing predict PVL after S3 TAVI. Further studies are needed to understand their mechanism and significance.