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Background: Despite impressive improvements in the safety profile of Transcatheter aortic valve replacement (TAVR), the risk for peri-procedural stroke after TAVR has not declined substantially. In an effort to reduce periprocedural stroke, cerebral embolic protection (CEP) devices have been utilized but have yet to demonstrate benefit in all-comers. There is a paucity of data supporting the utilization of CEP in TAVR patients with an anticipated high risk for peri-procedural stroke., Methods: The Transcatheter Aortic Valve Replacement In-Hospital Stroke (TASK) score is a clinical risk tool for predicting the in-hospital stroke risk of patients undergoing transfemoral TAVR. This score was used to identify high-risk patients and calculate the expected in-hospital stroke risk. This was a single-centre cohort study in all consecutive TAVR patients who had placement of CEP. The observed versus expected ratio for peri-procedural stroke was calculated. To obtain 95% credible intervals, we used 1000 bootstrapped samples of the original cohort sample size without replacement and recalculated the TASK predicted scores., Results: The study included 103 patients. The median age was 83 (IQR 78,89). 63 were male (61.1%) and 45 (43.69%) had a history of previous Stroke or TIA. Two patients had an in-hospital stroke after TAVR (1.94%). The expected risk of in-hospital stroke based on the TASK score was 3.39% (95% CI 3.07-3.73). The observed versus expected ratio was 0.57 (95% CI 0.52-0.64)., Conclusion: In this single-center study, we found that in patients undergoing TAVR with high stroke risk, CEP reduced the in-hospital stroke risk by 43% when compared with the risk-score predicted rate., Clinical Trial Number: N/A., (© 2024. The Author(s).)

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: The anatomic substrate of bicuspid valves may lead to suboptimal TAVR stent expansion and geometry., Aim: We evaluated determinants of stent geometry in bicuspid valves treated with Sapien transcatheter aortic valve replacement (TAVR) valves., Methods: A multicenter retrospective registry of patients (February 2019 to August 2022) who underwent post-TAVR computed tomography to determine stent area (vs. nominal valve area) and stent ellipticity (maximum diameter/minimum diameter). Predictors of relative stent expansion (minimum area/average of inflow + outflow area) and stent ellipticity were evaluated in a multivariable regression model, including valve calcium volume (indexed by annular area), presence of raphe calcium, sinus diameters indexed by area-derived annular diameter, and performance of pre-dilation and post-dilation., Results: The registry enrolled 101 patients from four centers. The minimum stent area (vs. nominal area) was 88.1%, and the maximum ellipticity was 1.10, with both observed near the midframe of the valve in all cases. Relative stent expansion ≥90% was observed in 64/101 patients. The only significant predictor of relative stent expansion ≥90% was the performance of post-dilation (OR: 4.79, p = 0.018). Relative stent expansion ≥90% was seen in 86% of patients with post-dilation compared to 57% without (p < 0.001). The stent ellipticity ≥1.1 was observed in 47/101 patients. The significant predictors of stent ellipticity ≥1.1 were the indexed maximum sinus diameter (OR: 0.582, p = 0.021) and indexed intercommisural diameter at 4 mm (OR: 2.42, p = 0.001). Stent expansion has a weak negative correlation with post-TAVR mean gradient (r = -0.324, p < 0.001)., Conclusion: Relative stent expansion ≥90% was associated with the performance of post-dilation, and stent ellipticity ≥1.1 was associated with indexed intercommisural diameter and indexed maximum sinus diameter. Further studies to determine optimal deployment strategies in bicuspid valves are needed., (© 2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Background: The etiology of transcatheter aortic valve (TAV) degeneration is poorly understood, particularly noncalcific mechanisms., Objectives: The authors sought to investigate noncalcific and calcific mechanisms of TAV degeneration and evaluate their impact on leaflet function by bench testing, imaging, and histology., Methods: TAV explants were obtained from the EXPLANT THV registry and clinical institutions. Hydrodynamic assessment was performed using a heart valve pulse duplicator system under physiological conditions. Micro-computed tomography, high-resolution photography, high speed video, and hematoxylin and eosin staining were used to evaluate the morphological appearance, leaflet kinematics, and calcium burden of TAVs., Results: A total of 14 explants were evaluated: 10 self-expanding CoreValve/Evolut TAVs (Medtronic), 3 balloon-expandable SAPIEN 3 TAVs (Edwards Lifesciences), and 1 mechanically expandable Lotus TAV (Boston Scientific). The median patient age at explantation was 73.0 years (Q1-Q3: 64.5-80.0 years), with a time to explantation of 4 years 1 month (1 year 5 months to 4 years 11 months). Six TAV explants were found to have leaflet calcification (162.4 mm 3 ; 58.8-603.0 mm 3 ), and 8 had no calcification detectable by micro-computed tomography and histology. All samples had impaired leaflet kinematics. There was no significant difference in the hydrodynamic mean gradient between calcified (47.2 mm Hg; 26.6-74.1 mm Hg) and noncalcified (27.6 mm Hg; 15.2-36.7 mm Hg; P = 0.28) TAVs. Leaflet calcification had a weak but nonsignificant association with the hydrodynamic mean gradient (r = 0.42; P = 0.14)., Conclusions: TAV function can be severely impacted by noncalcific and calcific mechanisms of tissue degeneration. Importantly, functional stenosis can occur in TAVs in the absence of obvious and significant calcification., Competing Interests: Funding Support and Author Disclosures This work was supported by Medtronic, USA, and the Cardiovascular Translational Laboratory, Canada. Dr Sathananthan is the chief medical officer for Interventional Cardiology Therapies from Boston Scientific; a consultant to Medtronic and Edwards Lifesciences; has received speaking fees from Edwards Lifesciences, and NVT; and has received research support from Medtronic, Edwards Lifesciences, and Vivitro Labs. Mr Nigade, Dr Spencer, and Mr Navarro are employees and shareholders of Medtronic. Dr Meier has received an institutional grant from Edwards Lifesciences. Dr Pirelli is a consultant and receives speakers honoraria from Medtronic and Edwards Lifesciences. Dr Webb is a consultant to and has received research funding from Edwards Lifesciences, Abbott, and ViVitro Labs. Dr Wood is a consultant and receives unrestricted grant support from Medtronic, Edwards Lifesciences, and Abbott Vascular. Dr Lutter is a consultant to Medtronic, Edwards Lifesciences, and Abbott. Dr Puehler is a consultant to Abbott. Dr Tang has received speaker honoraria and 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 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 Fukuhara is a consultant for Medtronic, Terumo Aortic, and Artivion. Dr Sellers is a consultant for Medtronic, Edwards Lifesciences, and Anteris; and has received research support from Medtronic, Edwards Lifesciences, Vivitro Labs, and HeartFlow. 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.)

Aims: Early mobilization is associated with improved outcomes in hospitalized older patients. We sought to determine the effect of a nurse-led protocol on mobilization 4 h after transfemoral transcatheter aortic valve implantation (TAVI) across different units of care., Methods and Results: We conducted a prospective observational cohort single-centre study of consecutive patients. We implemented a standardized protocol for safe early recovery and progressive mobilization in the critical care and cardiac telemetry units. We measured the time to first mobilization and conducted descriptive statistics to identify patient and system barriers to timely ambulation. We recruited 139 patients (82.5 years, SD = 6.7; 46% women). At baseline, patients who were mobilized early (≤4 h) and late (>4 h) did not differ, except for higher rates of diabetes (25.5% vs. 43.9%, P = 0.032) and peripheral arterial disease (8.2% vs. 26.8%, P = 0.003) in the late mobilization group. The median time to mobilization was 4 h [inter-quartile range (IQR) 3.25, 4]; 98 patients (70.5%) were mobilized successfully after 4 h of bedrest; 118 (84.9%) were walking by the evening of the procedure (<8 h bedrest); and 21 (15.1%) were on bedrest overnight and mobilized the following day. Primary reasons for overnight bedrest were arrhythmia monitoring (n = 10, 7.2%) and haemodynamic and/or neurological instability (n = 6, 4.3%); six patients (4.3%) experienced delayed ambulation due to system issues. Procedure location in the hybrid operating room and transfer to critical care were associated with longer bedrest times., Conclusion: Standardized nurse-led mobilization 4 h after TF TAVI is feasible in the absence of clinical complications and system barriers., Competing Interests: Conflict of interest: S.B.L. has been a consultant for Edwards and Medtronic; J.S. has been a consultant for Edwards, Medtronic, and Boston Scientific and received research grants from Edwards and Medtronic; D.A.W. has received research grants from Abbott and Edwards; J.G.W. has been a consultant and/or received research support from Edwards, Abbott, Boston Scientific, and Vivitro Medical., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

One of the most important medical interventions for individuals with heart valvular disease is heart valve replacement, which is not without substantial challenges, particularly for pediatric patients. Due to their biological properties and biocompatibility, natural tissue-originated scaffolds derived from human or animal sources are one type of scaffold that is widely used in tissue engineering. However, they are known for their high potential for immunogenicity. Being free of cells and genetic material, decellularized xenografts, consequently, have low immunogenicity and, thus, are expected to be tolerated by the recipient's immune system. The scaffold ultrastructure and ECM composition can be affected by cell removal agents. Therefore, applying an appropriate method that preserves intact the structure of the ECM plays a critical role in the final result. So far, there has not been an effective decellularization technique that preserves the integrity of the heart valve's ultrastructure while securing the least amount of genetic material left. This study demonstrates a new protocol with untraceable cells and residual DNA, thereby maximally reducing any chance of immunogenicity. The mechanical and biochemical properties of the ECM resemble those of native heart valves. Results from this study strongly indicate that different critical factors, such as ionic detergent omission, the substitution of Triton X-100 with Tergitol, and using a lower concentration of trypsin and a higher concentration of DNase and RNase, play a significant role in maintaining intact the ultrastructure and function of the ECM.

Aortic blood flow patterns are closely linked to the morphology and function of the left ventricle, aortic valve and aorta. These flow patterns demonstrate the exceptional adaptability of the cardiovascular system to maintain blood circulation under a broad range of haemodynamic workloads and can be altered in various pathophysiological states. For instance, normal ascending aortic systolic flow is predominantly laminar, whereas abnormal aortic systolic flow is associated with increased eccentricity, vorticity and flow reversal. These flow abnormalities result in reduced aortic conduit function and increased energy loss in the cardiovascular system. Emerging evidence details the association of these flow patterns with loss of aortic compliance, which leads to adverse left ventricular remodelling, poor tissue perfusion, and an increased risk of morbidity and death. In this Perspective article, we review the evidence for the link between aortic flow-related abnormalities and cardiovascular disease and how these changes in aortic flow patterns are emerging as a therapeutic target for aortic valve intervention in first-in-human studies., (© 2023. Springer Nature Limited.)

Background: Coronary artery disease (CAD) in patients with severe aortic stenosis (AS) is common and may be associated with worse outcomes. Computed tomography coronary angiography (CTCA) and fractional flow reserve derived from computed tomography (FFR CT ) are tools for comprehensive coronary assessment. The utility and safety of CTCA and FFR CT in the work-up for transcatheter aortic valve replacement (TAVR) is not established, especially in an evolving landscape that involves younger TAVR patients. The FUTURE-AS Registry will assess the utility and safety of cardiac-optimized CTCA and FFR CT to evaluate CAD and guide referral for downstream invasive coronary angiography (ICA) in patients with severe AS being considered for TAVR., Methods: FUTURE-AS is an international, prospective, multicenter registry of patients with severe AS referred for TAVR being assessed for CAD with CTCA and FFR CT . The primary end point is the per-patient sensitivity and negative predictive value of CTCA and FFR CT for identifying anatomical and physiologically significant CAD compared to ICA and invasive FFR. The safety end point is the incidence of symptomatic hypotension or bradycardia requiring intervention following the administration of nitroglycerin or β-blocker medications. Feasibility end points include the incidence of noninterpretable CTCA scans and CTCA scans not adequate for FFR analysis. Other utility end points include specificity, positive predictive value, and accuracy of CTCA and FFR CT . Lastly, the potential of a CTCA and FFR CT guided strategy to defer pre-TAVR ICA will be assessed., Conclusions: FUTURE-AS will characterize the utility, safety, and feasibility of CTCA and FFR CT for coronary assessment pre-TAVR., Competing Interests: Stephanie Sellers received institutional grants from Edwards Lifesciences, Medtronic, and HeartFlow; consulting fees from Edwards Lifesciences, Anteris Technologies, and Medtronic; and equipment loan agreement from ViVitro Labs. Venkateshwar Polsani is on the speaker bureau for HeartFlow. Janarthanan Sathananthan is an employee of Boston Scientific. Jonathon Leipsic received grants from GE HealthCare; consulting fees and stock options from HeartFlow and Circle Cardiovascular Imaging; personal core lab services from Arineta; and speaking fees from Philips and GE HealthCare. Abdul R. Ihdayhid received consultancy fees from Abbott Medical, Boston Scientific, and Artrya (including stock options). The other authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© 2024 The Author(s).)

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 . The significance of concomitant tricuspid regurgitation (TR) in the context of transcatheter aortic valve replacement (TAVR) remains unclear. This study aimed to analyze the severity of TR before and after TAVR with regard to short- and long-term survival and to analyze the influencing factors. Methods . In our retrospective analysis, TR before and after TAVR was examined and patients were classified into groups accordingly. Special attention was paid to patients with post-interventional changes in TR. Mortality after TAVR was considered the primary endpoint of the analysis and major complications according to the Valve Academic Research Consortium 3 (VARC3) were compared. Moreover, biomarkers and risk factors for worsening or improvement of TR through TAVR were analyzed. Results . Among 775 patients who underwent TAVR in our center between January 2009 and December 2019, 686 patients (89%) featured low- and 89 patients (11%) high-grade TR. High-grade pre-TAVR TR was associated with worse short- (30-day), mid- (2-year) and long-term survival up to 8 years. Even though in nearly half of the patients with high-grade TR the regurgitation improved within seven days after TAVR (n = 42/89), this did not result in a survival benefit for this subgroup. On the other hand, a worsening of low-grade TR was seen in more than 10% of the patients (n = 73/686), which was also associated with a worse prognosis. Predictors of worsening of TR after TAVR were adipositas, impaired right ventricular function and the presence of mild TR. Age, atrial fibrillation, COPD, impaired renal function and elevated cardiac biomarkers were risk factors for mortality after TAVR independent from the grade of TR. Conclusions . Not only pre-interventional, but also post-TAVR high-grade TR is associated with a worse prognosis after TAVR. TAVR can change concomitant tricuspid regurgitation, but improvement does not have any impact on short- and long-term survival. Worsening of TR after TAVR is possible and impairs the prognosis.

Competing Interests: Funding Support and Author Disclosures Dr Wood is a consultant for Edwards Lifesciences and Abbott; and has received research funding from Edwards Lifesciences and Abbott. Dr Leipsic is supported by a Canadian Research Chair in Advanced Cardiopulmonary Imaging; is a consultant for MVRX, Heartflow Inc, and Circle Cardiovascular Imaging; and provides CT core lab services for Edwards Lifesciences, Medtronic, Neovasc, Boston Scientific, and Tendyne Holdings for which no direct compensation is received. Dr Sathananthan has received speaker fees from Edwards Lifesciences; is a consultant for Edwards Lifesciences, Boston Scientific, NVT Medical, and Medtronic; and has received research support from Medtronic, Vivitro Labs, and Edwards Lifesciences. Dr Sellers is a consultant for Edwards Lifesciences, Anteris, Excision Medical, and Medtronic; and has received research support from Medtronic, Vivitro Labs, and Edwards Lifesciences. Dr Webb is a consultant for Edwards Lifesciences; and has received research funding from Edwards Lifesciences, Medtronic, and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Objectives: The SavvyWire(OpSens Medical) is a support wire for transcatheter aortic valve replacement (TAVR) procedures that, in addition to its dedicated left ventricle (LV) pacing capabilities, has a distal pressure sensor that measures live transvalvular hemodynamics during the procedure. We aimed to determine the safety, efficacy, and functionality of the SavvyWire during TAVR procedures in an all-comer population., Methods: We performed a multicentric, prospective, observational, single-arm, all-comers registry of patients with symptomatic, severe aortic stenosis undergoing TAVR in 3 Canadian centers. Data were collected in a dedicated database, and pre-specified questionnaires were fulfilled by the heart team implanters after each procedure., Results: A total of 60 patients were included (mean age: 78.6 ± 7.2 years; 51% women; mean Society of Thoracic Surgeons score: 2.2 ± 1.6%). TAVR was performed through a transfemoral approach in 90% of cases, and balloon- and self-expandable valves were used in 73% and 27% of patients, respectively. There were no cases of LV perforation, guidewire deformation, significant loss of capture, or major software malfunction. The rate of successful delivery of the TAVR system was 100%, and effective LV pacing was achieved in 98% of patients. The pre-TAVR mean gradient was 39 ± 14 mm Hg while the final post-TAVR gradient was 8 ± 5 mm Hg; the mean aortic systolic pressure during rapid pacing was 54 ± 12 mm Hg. In 97% of the TAVR procedures, SavvyWire's functionality was reported to be better or similar to other TAVR workhorse support wires., Conclusions: SavvyWire was safe, effective, and functional for live transvalvular hemodynamic evaluation and rapid pacing during TAVR procedures. More studies with larger sample sizes and comparison against different wires and gradient measurement methods are warranted.

Aortic stenosis is the most common valvular disease. Surgical aortic valve replacement (SAVR) using mechanical valves has been the preferred treatment for younger patients, but bioprosthetic valves are gaining favour to avoid anticoagulation with warfarin. Transcatheter aortic valve replacement (TAVR) was approved in recent years for the treatment of severe aortic stenosis in intermediate- and low-risk patients as an alternative to SAVR. The longer life expectancy of these groups of patients might exceed the durability of the TAVR or SAVR bioprosthetic valves. Therefore, many patients need 2 or even 3 interventions during their lifetime. Because it has important implications on the feasibility of subsequent procedures, the decision between opting for SAVR or TAVR as the primary procedure requires thorough consideration by the heart team, incorporating patient preferences, clinical indicators, and anatomic aspects. If TAVR is favoured initially, selecting the valve type and determining the implantation level should be conducted, aiming for positive outcomes in the index intervention and keeping in mind the potential for subsequent TAVR-in-TAVR procedures. When SAVR is selected as the primary procedure, the operator must make choices regarding the valve type and the potential need for aortic root enlargement, with the intention of facilitating future valve-in-valve interventions. This narrative review examines the existing evidence concerning the lifelong management of severe aortic stenosis, delving into available treatment strategies, particularly emphasising the initial procedure's selection and its impact on subsequent interventions., (Copyright © 2023 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)