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Background: The fifth-generation SAPIEN 3 Ultra Resilia valve (S3UR) incorporates several design changes as compared with its predecessors, the SAPIEN 3 (S3) and SAPIEN 3 Ultra (S3U) valves, including bovine leaflets treated with a novel process intended to reduce structural valve deterioration via calcification, as well as a taller external skirt on the 29-mm valve size to reduce paravalvular leak (PVL). The clinical performance of S3UR compared with S3 and S3U in a large patient population has not been previously reported., Objectives: The aim of this study was to compare S3UR to S3/S3U for procedural, in-hospital, and 30-day clinical and echocardiographic outcomes after transcatheter aortic valve replacement (TAVR)., Methods: Patients enrolled in the STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry between January 1, 2021, and June 30, 2023, who underwent TAVR with S3UR or S3U/S3 valve platforms were propensity-matched and evaluated for procedural, in-hospital, and 30-day clinical and echocardiographic outcomes., Results: 10,314 S3UR patients were propensity matched with 10,314 patients among 150,539 S3U/S3 patients. At 30 days, there were no statistically significant differences in death, stroke, or bleeding, but a numerically higher hospital readmission rate in the S3UR cohort (8.5% vs 7.7%; P = 0.04). At discharge, S3UR patients exhibited significantly lower mean gradients (9.2 ± 4.6 mm Hg vs 12.0 ± 5.7 mm Hg; P < 0.0001) and larger aortic valve area (2.1 ± 0.7 cm 2 vs 1.9 ± 0.6 cm 2 ; P < 0.0001) than patients treated with S3/S3U. The 29-mm valve size exhibited significant reduction in mild PVL (5.3% vs 9.4%; P < 0.0001)., Conclusions: S3UR TAVR is associated with lower mean gradients and lower rates of PVL than earlier generations of balloon expandable transcatheter heart valve platforms., Competing Interests: Funding Support and Author Disclosures Dr Stinis has received consulting fees from Edwards Lifesciences, Medtronic, Boston Scientific, and Shockwave Medical; and serves on an advisory board for Boston Scientific. Dr Abbas has received research grants and consulting fees from Edwards Lifesciences. Dr Teirstein has received research grant and honoraria from Abbott, Boston Scientific, Cordis, and Medtronic; and serves on advisory boards for Boston Scientific and Medtronic. Dr Makkar has received grant support/research contracts from Edwards Lifesciences and St. Jude Medical; and has received consultant fees/honoraria and served on the Speakers Bureaus of Abbott Vascular, Cordis Corporation, and Medtronic. Dr Généreux has been a consultant for Abbott Vascular, Abiomed, BioTrace Medical, Boston Scientific, CARANX, Cardiovascular Systems Inc (for the PI Eclipse Trial), Edwards Lifesciences, GE Healthcare, iRhythm Technologies, Medtronic, Opsens, Pi-Cardia, Puzzle Medical, Saranas, Shockwave, Siemens, Soundbite Medical Inc, Teleflex, and 4C Medical (for the PI Feasibility study). Dr Huang has received speaker honoraria from Abbott Vascular; and has received consulting fees from Edwards Lifesciences. Dr Aragon received has consultant fees from Edwards Lifesciences. Dr McCabe has received fees from Edwards Lifesciences, Boston Scientific, and Teleflex outside the submitted work. Statistical analyses were performed by Edwards Lifesciences. The views or opinions presented here do not represent those of the American College of Cardiology (ACC), Society of Thoracic Surgeons (STS), or the STS/ACC TVT Registry. 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.)

Objectives: This study sought to evaluate the outcomes and factors associated with aborted procedures among patients undergoing elective transcatheter aortic valve replacement (TAVR)., Background: Elective TAVR procedures can be aborted because of device limitations or aborted for other reasons, including patient and procedural factors. Little is known about 30-day outcomes and factors associated with aborted procedures and procedures aborted because of device limitations (ADs)., Methods: Patients undergoing elective TAVR procedures from 2011 to 2017 in the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry were examined. The incidence of aborted procedures, both ADs and procedures aborted for other reasons (AOs), was examined. Rates of 30-day all-cause death or stroke and a composite of vascular complications and bleeding events were compared between patients with and those without aborted procedures and between patients with ADs and those with AOs. Multivariate modeling identified factors associated with aborted procedures and ADs., Results: Among 106,169 patients who underwent TAVR between 2011 and 2017, procedures were aborted in 1,150 (1.1%) (581 ADs and 569 AOs). Patients with aborted procedures were more likely female with peripheral artery disease and more often treated at lower volume centers compared with those with nonaborted procedures (p < 0.01 for all). The incidence of aborted procedures and ADs decreased over the study period (p < 0.01). The adjusted rates of 30-day death and stroke were greater for aborted versus nonaborted procedures (odds ratio: 5.02; 95% confidence interval: 4.13 to 6.11). Peripheral artery disease, alternative access, and low institutional TAVR volume were factors associated with aborted procedures and ADs (p < 0.05 for all)., Conclusions: The incidence of aborted procedures is declining, but peripheral artery disease and low institutional TAVR volume remain associated with aborted procedures. A thorough pre-procedural assessment and referral of challenging cases to high-volume centers may be strategies to minimize aborted procedures., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to evaluate incidence, care patterns, and clinical outcomes in patients developing new-onset atrial fibrillation (AF) following transcatheter aortic valve replacement (TAVR)., Background: Pre-procedural AF has been associated with adverse outcomes in patients undergoing TAVR, but the incidence of new-onset AF, associated anticoagulant management, and subsequent clinical outcomes are unclear., Methods: Using the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry linked with Medicare claims, patients undergoing TAVR from 2011 to 2015 who developed post-procedural AF were evaluated. Patients with known AF prior to TAVR were excluded. Outcomes of interest included in-hospital mortality and stroke and all-cause mortality, stroke, and bleeding at 12 months. Multivariate adjustment was then performed to determine differences in 1-year outcomes among those with and without new post-procedural AF, stratified by anticoagulation status., Results: We identified 1,138 of 13,556 patients (8.4%) who developed new onset AF (4.4% of transfemoral [TF]-access patients, 16.5% of non-TF-access patients). Patients developing AF were older, more likely female, had higher Society of Thoracic Surgeons risk scores, and were often treated using non-TF access. Despite having a median CHA 2 DS 2 -VASc score of 5 (25th and 75th percentile: 5 to 6), only 28.9% of patients with new AF were discharged on oral anticoagulation. In-hospital mortality (7.8% vs. 3.4%; p < 0.01) and stroke (4.7% vs. 2.0%; p < 0.01) were higher among patients who developed post-procedural AF compared with those who did not. At 1 year, rates of death (adjusted hazard ratio [HR]: 1.37; 95% confidence interval [CI]: 1.19 to 1.59), stroke (adjusted HR: 1.50; 95% CI: 1.14 to 1.98), and bleeding (adjusted HR: 1.24; 95% CI: 1.10 to 1.40) were higher among patients with new-onset AF. One-year mortality rates were highest among patients who developed new-onset AF but were not discharged on anticoagulation., Conclusions: Post-TAVR AF occurred in 8.4% of patients (4.4% with TF access, 16.5% with non-TF access), with fewer than one-third of patients receiving anticoagulation at discharge, and was associated with increased risk for in-hospital and 1-year mortality and stroke. Given the clinical significance of post-TAVR AF, additional studies are necessary to delineate the optimal management strategy in this high-risk population., (Copyright © 2018. Published by Elsevier Inc.)

Objectives: This study sought to evaluate this transcatheter aortic valve (TAV) bioprosthesis in patients who are poorly suitable for surgical aortic valve (AV) replacement., Background: A novel self-expandable TAV bioprosthesis was designed to provide a low-profile delivery system, conformable annular sealing, and the ability to resheath and reposition during deployment., Methods: The Evolut R U.S. study included 241 patients with severe aortic stenosis who were deemed to be at least high risk for surgery treated at 23 clinical sites in the United States. Clinical outcomes at 30 days were evaluated using Valve Academic Research Consortium-2 criteria. An independent echocardiography laboratory was used to evaluate hemodynamic outcomes., Results: Patients were elderly (83.3 ± 7.2 years of age) and had high surgical risk (Society of Thoracic Surgeons predicted risk of mortality of 7.4 ± 3.4%). The majority of patients (89.5%) were treated by iliofemoral access. Resheathing or recapturing was performed in 22.6% of patients; more than 1 valve was required in 3 patients (1.3%). The 30-day outcomes included all-cause mortality (2.5%), disabling stroke (3.3%), major vascular complications (7.5%), life-threatening or disabling bleeding (7.1%), and new permanent pacemaker (16.4%). AV hemodynamics were markedly improved at 30 days: the mean AV gradient was reduced from 48.2 ± 13.0 mm Hg to 7.8 ± 3.1 mm Hg (p < 0.001) and AV area increased from 0.6 ± 0.2 cm 2 to 1.9 ± 0.5 cm 2 (p < 0.001). Moderate residual paravalvular leak was identified in 5.3% of patients., Conclusions: We conclude that this novel self-expanding TAV bioprosthesis is safe and effective for the treatment of patients with severe aortic stenosis who are suboptimal for surgery. (Medtronic CoreValve Evolut R U.S. Clinical Study; NCT02207569)., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to explore the impact of balloon post-dilation (BPD) on outcomes in the CoreValve US Clinical Trials., Background: BPD following transcatheter aortic valve replacement (TAVR) has been used in selected cases to optimize hemodynamic results., Methods: Procedural details of 3,532 patients were examined to determine whether BPD was performed after self-expanding TAVR. "Best practice" guidelines recommended BPD for treatment of suboptimal intraprocedural valve function, primarily manifested by moderate or severe residual aortic regurgitation (AR)., Results: Procedural BPD was performed in 782 patients (22%) patients. The most common (58.1%) indication was greater than or equal to moderate AR following valve deployment. Greater baseline aortic valve gradients (p < 0.001), higher grades of baseline AR (p < 0.001), larger annular diameters (p < 0.001), and lower device to annular ratios (p < 0.001) were more common in patients who underwent BPD. BPD was performed less often with the 26-mm valve (17.9%) compared to the 31 mm (38.1%) (p < 0.05). BPD reduced moderate or severe AR by 75.6% from 58.1% to 14.2%. Thirty-day and 1-year clinical events were similar in the 2 groups, although acute kidney injury was more common in patients undergoing BPD (p = 0.026). In-hospital major adverse cardiovascular and cerebrovascular event rates were 9.3% in the BPD group versus 7.5% for others (p = NS). There was no increase in neurological events., Conclusions: BPD of the self-expanding bioprosthesis was performed in 22% of patients in the CoreValve US Clinical Trials most commonly to reduce the degree of residual AR. BPD was effective in acutely improving valve performance without an associated increase in neurologic events. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902; Safety and Efficacy Continued Access Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement; NCT01531374)., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)