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Background: Mid-term comparative data for the self-expanding ACURATE neo2 transcatheter heart valve and the balloon-expandable SAPIEN 3 Ultra are lacking., Objectives: The aim of this study was to compare 1-year outcomes after transcatheter aortic valve replacement of these 2 valves., Methods: A total of 2,106 patients from 3 centers (neo2, n = 1,166; Ultra, n = 940) undergoing transfemoral transcatheter aortic valve replacement were analyzed retrospectively. The primary endpoint was the composite of all-cause mortality, stroke, and rehospitalization at 1 year. Secondary endpoints were the individual components of the primary endpoint at 1 year. To adjust for baseline differences, nearest neighbor propensity score matching was used., Results: After matching (702 pairs), baseline characteristics were similar between groups. Device success was more common in the neo2 group (87.5% vs 82.3%; P = 0.007), irrespective of matching. DP mean after the procedure was higher for Ultra (13 mm Hg [Q1-Q3: 10-15 mm Hg] vs 8 mm Hg [Q1-Q3: 6-11] mm Hg; P < 0.001). Rates of paravalvular leakage, device embolization, and multiple valve implantations were more common in the neo2 arm, whereas major cardiac structural complications and major vascular complications occurred more frequently in the Ultra group. All other in-hospital complication rates were similar between the 2 groups. At 1 year, the cumulative incidence of the primary endpoint (14.1% for neo2 vs 14.5% for Ultra; P = 0.819) was similar between the groups. Likewise, the individual components showed no difference between the groups., Conclusions: Despite differing immediate results, the outcomes at 1 year, including the composite of all-cause mortality, stroke, or hospitalization, were similar for neo2 and Ultra transcatheter heart valves., Competing Interests: Funding Support and Author Disclosures Dr Kim has received proctor and/or speaker and/or advisory honoraria from Abbott, Boston Scientific, Edwards Lifesciences, Meril Life Sciences, Shockwave, and HID Imaging. Dr Choi has received speaker and proctor fees from Edwards Lifesciences, CytoSorbents, and Getinge. Dr Charitos is a proctor for Boston Scientific. Dr Rheude has received lecture fees from Abbott, AstraZeneca, SIS Medical, and Translumina; and has received travel support from Boston Scientific and Eli Lilly (not related to the present work). Dr Joner has received lecture fees and research grants from Edwards Lifesciences and Boston Scientific; and is a consultant for Biotronik and OrbusNeich. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.)

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

Background: Prosthesis-patient mismatch after transcatheter aortic valve replacement (TAVR) can be measured echocardiographically (measured prosthesis-patient mismatch [PPMm]) or predicted (predicted prosthesis-patient mismatch [PPMp]) using published effective orifice area (EOA) reference values. However, the clinical implications of PPM post-TAVR remain unclear., Objectives: This study aimed to elucidate the prevalence of PPMm and PPMp post-TAVR and their impact on mortality in a large international cohort., Methods: The IMPPACT TAVR (Impact of Measured or Predicted Prosthesis-pAtient mismatCh after TAVR) registry included 38,808 TAVR patients from 26 international centers. Valve Academic Research Consortium 3 criteria were used to define prosthesis-patient mismatch severity. EOA was determined echocardiographically (PPMm) or predicted (PPMp) based on core lab-derived EOA reference values. The primary endpoint was 2-year all-cause mortality., Results: The prevalence of PPMp (moderate: 6.8%, severe: 0.6%) was significantly lower than that of PPMm (moderate: 20.7%, severe: 4.3%; P < 0.001) with negligible correlation between the 2 methods (Kendall's tau c correlation coefficient: 0.063; P < 0.001). In unadjusted analyses, severe PPMm adversely influenced 2-year survival (HR: 1.22; 95% CI: 1.02-1.45; P = 0.027), whereas severe PPMp was not associated with outcomes (HR: 0.81; 95% CI: 0.55-1.19; P = 0.291). After adjusting for confounders, neither PPMm nor PPMp had a significant effect on 2-year all-cause mortality., Conclusions: PPMm and PPMp were associated with different patient characteristics, with PPMm tending toward worse (especially low flow) and PPMp toward better (especially women) survival. After adjusting for confounders, neither PPMm nor PPMp significantly affected 2-year all-cause mortality. Hence, valve selection should not solely be based on hemodynamics but rather on a holistic approach, including patient and procedural specifics., Competing Interests: Funding Support and Author Disclosures This work was supported by the Deutsche Forschungsgemeinschaft (397484323) to Drs Guthoff, Matti Adam and Stephan Baldus, and Mauri; PA 2409/5-2 to Drs Thurow and Pauly; the Dean’s Office, Faculty of Medicine, University of Cologne (clinician scientist position) to Dr Guthoff; and the Center for Molecular Medicine Cologne (Baldus B-02) to Dr Stephan Baldus. Dr Abdel-Wahab’s institution has received speaker honoraria and/or consultancy fees from Abbott, Boston Scientific, and Medtronic. Dr Kim has received proctor and personal fees from Abbott, Boston Scientific, Meril Life Sciences, and Shockwave Med; is a member of the advisory boards for Abbott, Boston Scientific, and HID Imaging; and Dr Kim’s institution has received fees from Boston Scientific. Dr Nombela-Franco has served as proctor for Abbott and Edwards Lifesciences. Dr Matjaz Bunc served as proctor for TAVR procedures with Edwards Lifesciences, Medtronic, Meril, and Abbott. Matjaz Bunc is a member of the advisory boards for Medtronic and Edwards Lifesciences. Dr Veulemans has received speaker and/or study honoraria from Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Tanja Rudolph has received lecture fees from Abbott, SIS Medical and Translumina. Dr Zeus has received speaker and/or study honoraria 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., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Coronary access (CA) and percutaneous coronary intervention (PCI) might be challenging after valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) with supra-annular self-expanding valves (SS-TAVs) in surgical aortic valves (SAVs). Our study aim was to compare feasibility, predictors, and techniques of CA and PCI following ViV-TAVR with ACURATE neo2 (Boston Scientific, Marlborough, MA) and Evolut PRO+ (Medtronic, Minneapolis, MN)., Methods: Fifteen computed tomography (CT)-based patient-specific aortic models were 3-dimensionally (3D) printed and implanted with specific SAVs and with the 2 SS-TAVs with commissural alignment. Two operators attempted CA (n = 120) and PCI (n = 120) of each coronary artery in a pulsatile-flow-simulator, under real catheterization laboratory conditions. The primary endpoints were the rate of successful CA and PCI. Outcomes with different SS-TAVs were directly compared. An internally mounted borescope camera was used to assess procedures. CT of the models was obtained., Results: ACURATE neo2 showed significantly higher rates of successful CA (96.7% vs 75%, P = 0.001) and PCI (98.3% vs 85%, P = 0.008) and was associated with a shorter procedural time compared with Evolut PRO+. Independent predictors of unsuccessful CA and PCI were smaller SAV size and Evolut PRO+. The advantage of ACURATE neo2 was mediated by a larger valve-to-anatomy distance at the top of the leaflet plane (11.3 mm vs 4.8 mm), facilitating more often an external cannulation approach for both CA (36.7% vs 15%, P < 0.001) and PCI (36.7% vs 21.7%, P = 0.013)., Conclusions: The rate of successful CA and PCI following ViV-TAVR was higher with ACURATE neo2 compared with Evolut PRO+. The differences in SS-TAVs design affected the cannulation approach and subsequent procedural outcomes., (Copyright © 2024 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Background: Balloon-expandable valves (BEVs) and self-expanding valves (SEVs) have different features that may impact the outcomes of patients with Sievers type 1 bicuspid aortic valve (BAV) stenosis undergoing transcatheter aortic valve replacement., Objectives: This study sought to compare procedural and clinical outcomes of BEVs and SEVs in Sievers type 1 BAV stenosis., Methods: AD-HOC (Characteristics, Sizing, and Outcomes of Stenotic Raphe-Type Bicuspid Aortic Valves Treated With Transcatheter Device Implantation) is an observational registry enrolling patients with Sievers type 1 BAV stenosis undergoing transcatheter aortic valve replacement with current-generation BEVs and SEVs at 24 international centers. A 1:1 propensity score matching analysis was performed to adjust for baseline imbalances. The primary endpoint was midterm major adverse events, defined as a composite of all-cause death, neurologic events, or hospitalization for heart failure., Results: Among 955 eligible patients, propensity score matching resulted in 301 pairs. At a median follow-up of 1.3 years, BEVs and SEVs had a similar risk of major adverse events (BEV vs SEV: HR: 0.75; 95% CI: 0.49-1.16; P = 0.200). Technical success was similar (OR: 1.38; 95% CI: 0.63-3.04; P = 0.421). At 30 days, BEVs were associated with a lower risk of new permanent pacemaker implantation (OR: 0.42; 95% CI: 0.24-0.72; P = 0.002) and moderate or greater paravalvular regurgitation (OR: 0.16; 95% CI: 0.05-0.48; P = 0.001) but a higher risk of severe patient-prosthesis mismatch (OR: 3.03; 95% CI 1.02-8.95; P = 0.045)., Conclusions: Current-generation BEVs and SEVs proved similar technical success and midterm clinical efficacy in Sievers type 1 BAV stenosis. Compared to SEVs, BEVs were associated with less permanent pacemaker implantation and moderate or greater paravalvular regurgitation but with more severe patient-prosthesis mismatch., Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve replacement (TAVR) is increasingly performed for the treatment of aortic stenosis. Computed tomography (CT) analysis is essential for pre-procedural planning. Currently available software packages for TAVR planning require substantial human interaction. We describe development and validation of an artificial intelligence (AI) powered software to automatically rend anatomical measurements and other information required for TAVR planning and implantation., Methods: Automated measurements from 100 CTs were compared to measurements from three expert clinicians and TAVR operators using commercially available software packages. Correlation coefficients and mean differences were calculated to assess precision and accuracy., Results: AI-generated annular measurements had excellent agreements with manual measurements by expert operators yielding correlation coefficients of 0.97 for both perimeter and area. There was no relevant bias with a mean difference of -0.07 mm and - 1.4 mm 2 for perimeter and area, respectively. For the ascending aorta measured 5 cm above the annular plane, correlation coefficient was 0.95 and mean difference was 1.4 mm. Instruction for use-based sizing yielded agreement with the effective implant size in 87-88 % of patients for self-expanding valves (perimeter-based sizing) and in 88 % for balloon-expandable valves (area-based sizing)., Conclusions: A fully automated software enables accurate and precise anatomical segmentation and measurements required for TAVR planning without human interaction and with high reliability., Competing Interests: Declaration of competing interest Relationship with industry: ST has received honoraria from Medtronic, Boston Scientific, Biosensors, Hi-D Imaging, Abbott Vascular, Medira, Shockwave, Teleflex, atHeart Medical, Cardiac Dimensions, Polares Medical, Amarin, Sanofi, AstraZeneca, ReCor Medical, Daiichi Sankyo, has received institutional research grants from Edwards Lifesciences, Abbott Vascular, Boston Scientific, Fumedica, Novartis, Boehringer Ingelheim, Polares Medical, and holds equity in Hi-D Imaging. MCWVB is a consultant for Hi-D Imaging, Boston Scientific, Medtronic Inc., and Sanamedi Inc. FM is a consultant for Hi-D Imaging. UG holds equity in Hi-D Imaging. MW is a proctor and consultant for Biosensors and holds equity in Hi-D Imaging. WK received personal fees from Abbott, Boston Scientific Edwards Lifesciences, Meril Life Sciences, is consultant to Hi-D imaging and received institutional fees from Boston Scientific., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

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

Background: Transcatheter aortic valve implantation is an established, guideline-endorsed treatment for severe aortic stenosis. Precise sizing of the balloon-expandable Myval transcatheter heart valve (THV) series with the aortic annulus is facilitated by increasing its diameter in 1·5 mm increments, compared with the usual 3 mm increments in valve size. The LANDMARK trial aimed to show non-inferiority of the Myval THV series compared with the contemporary THVs Sapien Series (Edwards Lifesciences, Irvine, CA, USA) or Evolut Series (Medtronic, Minneapolis, MN, USA)., Methods: In this prospective, multinational, randomised, open-label, non-inferiority trial across 31 hospitals in 16 countries (Germany, France, Sweden, the Netherlands, Italy, Spain, New Zealand, Portugal, Greece, Hungary, Poland, Slovakia, Slovenia, Croatia, Estonia, and Brazil), 768 participants with severe symptomatic native aortic stenosis were randomly assigned (1:1) to the Myval THV or a contemporary THV. Eligibility was primarily decided by the heart team in accordance with 2021 European Society of Cardiology guidelines. As per the criteria of the third Valve Academic Research Consortium, the primary endpoint at 30 days was a composite of all-cause mortality, all stroke, bleeding (types 3 and 4), acute kidney injury (stages 2-4), major vascular complications, moderate or severe prosthetic valve regurgitation, and conduction system disturbances resulting in a permanent pacemaker implantation. Non-inferiority of the study device was tested in the intention-to-treat population using a non-inferiority margin of 10·44% and assuming an event rate of 26·10%. This trial is registered with ClinicalTrials.gov, NCT04275726, and EudraCT, 2020-000137-40, and is closed to new participants., Findings: Between Jan 6, 2021, and Dec 5, 2023, 768 participants with severe symptomatic native aortic stenosis were randomly assigned, 384 to the Myval THV and 384 to a contemporary THV. 369 (48%) participants had their sex recorded as female, and 399 (52%) as male. The mean age of participants was 80·0 years (SD 5·7) for those treated with the Myval THV and 80·4 years (5·4) for those treated with a contemporary THV. Median Society of Thoracic Surgeons scores were the same in both groups (Myval 2·6% [IQR 1·7-4·0] vs contemporary 2·6% [1·7-4·0]). The primary endpoint showed non-inferiority of the Myval (25%) compared with contemporary THV (27%), with a risk difference of -2·3% (one-sided upper 95% CI 3·8, p non-inferiority <0·0001). No significant difference was seen in individual components of the primary composite endpoint., Interpretation: In individuals with severe symptomatic native aortic stenosis, the Myval THV met its primary endpoint at 30 days., Funding: Meril Life Sciences., Competing Interests: Declaration of interests NvR reports grant funding and personal fees from Abbott; grants from Philips, Biotronik, and Medtronic; and personal fees from MicroPort, Bayer, and RainMed Medical outside the submitted work. IJA-S reports being a proctor for Medtronic, Boston Scientific, and Meril Life Sciences. AIj reports consulting fees from Meril Life Sciences, Medtronic, Angiocare, Keystone Heart, PulseCath, Salveo, Abbott, Philips, Fysicon, Cardiawave, Pi Medical, and Svelte. DU reports lecture and educational event fees from Medtronic; a lecture fee from and being a proctor for Meril Life Sciences; and being a member of the Medtronic EMEA surgical advisory board. RSH reports grant funding from Bayer; and speaker fees from Amgen, Novartis, and Abbott outside the submitted work. MW reports institutional research funding from Emboline, Meril Life Sciences, Edwards Lifesciences, and TransAortic Medical. MPa reports honoraria from Boston Scientific, Philips, and Abbott. OA reports research grants and lecture fees from and being a proctor for Abbott; and advisory board participation for and support for attending meetings from Meril Life Sciences. W-KK reports honoraria or consultancy fees from Abbott, Boston Scientific, Edwards Lifesciences, Meril Life Sciences, and Hi-D Imaging; and participation on an advisory board or data and safety monitoring board for Abbott and Boston Scientific. JR reports being a consultant with Medtronic and Qatma; being a proctor for Medtronic; and travel support for attending meetings from Meril Life Sciences, Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific. AT reports a grant from the Fukuda Foundation for Medical Technology. SG reports honoraria or consultancy fees from Biosensors. PWS reports consultancy fees from SMT, Novartis, Meril Life Sciences, Xeltis, and Philips. All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.)

Objectives: High incidences of haemorrhagic fever with renal syndrome (HFRS) have been reported in the southern Republic of Korea (ROK). A distinct southern genotype of Orthohantavirus hantanense (HTNV) was identified in Apodemus agrarius chejuensis on Jeju Island. However, its association with HFRS cases in southern ROK remains elusive. We investigated the potential of the southern HTNV genotype as an etiological agent of HFRS., Methods: Samples from 22 patients with HFRS and 193 small mammals were collected in the southern ROK. The clinical characteristics of patients infected with the southern HTNV genotype were analysed. Amplicon-based MinION sequencing was employed for southern HTNV from patients and rodents, facilitating subsequent analyses involving phylogenetics and genetic reassortment., Results: High-throughput sequencing of HTNV exhibited higher coverage with a cycle of threshold value below 32, acquiring nearly whole-genome sequences from six patients with HFRS and seven A. agrarius samples. The phylogenetic pattern of patient-derived HTNV demonstrated genetic clustering with HTNV from Apodemus species on Jeju Island and the southern Korean peninsula, revealing genetic reassortment in a single clinical sample between the M and S segments., Discussion: These findings imply that the southern HTNV genotype has the potential to induce HFRS in humans. The phylogenetic inference demonstrates the diverse and dynamic characteristics of the southern HTNV tripartite genomes. Therefore, this study highlights the significance of active surveillance and amplicon sequencing for detecting orthohantavirus infections. It also raises awareness and caution for physicians regarding the emergence of a southern HTNV genotype as a cause of HFRS in the ROK., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Background: ACURATE neo2 (Neo2) implantation is performed after systematic Balloon Aortic Valvuloplasty (BAV) in most patients. No reports exist about the feasibility and safety of direct Neo2 transcatheter aortic valve implantation (TAVI) in comparison to the standard practice., Aim: We aimed to identify the patients' baseline anatomical characteristics, procedural, and early post-procedural outcomes in patients treated using Neo2 with and without BAV., Methodology: This is a retrospective multicentre analysis of 499 patients with severe aortic stenosis who underwent TAVI using Neo2. The comparison was done according to the performance or omission of BAV. Echocardiography and computed tomography were analysed by an independent Core Lab. Propensity score matching (PSM) was performed based on the annular diameter and AV calcium volume, which identified 84 matched pairs., Results: Among the cohort included, 391 (78%) patients received BAV (BAV-yes) and 108 (22%) were not attempted (BAV-no or Direct TAVI). Patients in BAV-no cohort had smaller annular diameter (22.6 vs 23.4 mm; p < 0.001) and lower calcium volume (163 vs 581 mm 3 ; p < 0.001) compared to BAV-yes cohort. In the matched cohort, VARC-3 device technical success was similar (95%) and all other outcome measures were statistically comparable between cohorts., Conclusion: Direct TAVI using ACURATEneo2 without pre-TAVI balloon aortic valvuloplasty in patients with mild or less valve calcifications might be feasible and associated with comparable early outcomes compared to patients with similar anatomical features undergoing systematic balloon valvuloplasty., Competing Interests: Declaration of competing interest WK Kim reports proctor/speaker fees/advisory board participation for Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, Meril Life Sciences, and Shockwave Medical. A Rück reports grants and non-financial support from Boston Scientific, during the conduct of the study; grants and personal fees from Boston Scientific, personal fees from Edwards Lifesciences, outside the submitted work. M Abdel-Wahab reports speakers' honoraria and/or consulting fees from Boston Scientific and Medtronic paid to his institution on his behalf. TK Rudolph reports speakers' honoraria and/or consulting fees from Boston Scientific, Edwards Lifesciences, and Medtronic, paid to her institution on her behalf. She also reports institutional research grants from Boston Scientific. A Wolf reports proctoring for Boston Scientific. De Backer reports institutional research grants and consulting fees from Boston Scientific. L Sondergaard is a Chief Medical Officer and Divisional Vice President, Medical Affairs, Abbott Structural Heart. C Hengstenberg reports proctor/speaker fees/advisory board participation for Boston Scientific and Edwards Lifesciences as well as institutional research grants from Medtronic, Abbott, Boston Scientific and Edwards Lifesciences. H Bjursten reports work as consultant for Boston Scientific and receipt of speaker fees from Edwards Lifescience. M Götberg reports proctor/consulting fees from Boston Scientific, and consulting/speaker fees from Abbott, Medtronic, and Philips Healthcare. N Saleh reports grants and non-financial support from Boston Scientific, during the conduct of the study; grants and personal fees from Boston Scientific. C Meduri reports advisory board participation and proctoring for Boston Scientific, consulting for Medtronic, and advisory board participation for Cardiovalve and Anteris. O Soliman reports several institutional grants and non-financial support from industry, and is the medical director of Computed Tomography, Echocardiography and Cardiac MRI Core Laboratory at the CORRIB Core Lab for multiple industry-sponsored trials, for which he receives no direct industry compensation. The remaining authors have no disclosures to report., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Inferior outcomes with ACURATE neo, a self-expanding transcatheter heart valve (THV) for the treatment of severe aortic stenosis, were mainly driven by higher rates of moderate/severe paravalvular leak (PVL). To overcome this limitation, the next-generation ACURATE neo2 features a 60% larger external sealing skirt. Data on long-term performance are limited; however, clinical evidence suggests improved short-term performance which is comparable to contemporary THVs. This report reviews data on short-term clinical and echocardiographic outcomes of ACURATE neo2. A PubMed search yielded 13 studies, including 5 single arm and 8 nonrandomized comparative studies with other THVs which reported in-hospital or 30-day clinical and echocardiographic outcomes. In-hospital or 30-day all-cause mortality was ≤3.3%, which is comparable to other contemporary THVs. The rates of postprocedural ≧moderate PVL ranged 0.6%-4.7%. In multicenter propensity-matched analyses, neo2 significantly reduced the rate of ≧moderate PVL compared to neo (3.5% vs. 11.3%, p < 0.01), whereas rates were comparable to Evolut Pro/Pro+ (Neo2: 2.0% vs. Pro/Pro+: 3.1%, p = 0.28) and SAPIEN 3 Ultra (Neo2: 0.6% vs. Ultra: 1.1%, p = 0.72). The rate of permanent pacemaker implantation with neo2 was consistently low (3.3%-8.6%) except in one study, and in propensity-matched analyses were significantly lower than Evolut Pro/Pro+ (6.7% vs. 16.7%, p < 0.01), and comparable to SAPIEN 3 Ultra (8.1% vs. 10.3%, p = 0.29). In conclusion, ACURATE neo2 showed better short-term performance by considerably reducing PVL compared to its predecessor, with short-term clinical and echocardiographic outcomes comparable to contemporary THVs., Competing Interests: Akihiro Tobe receives a grant from Fukuda foundation for medical technology. Helge Mollmann receives grants, consulting and lecture fees from Abbot, Boston Scientific, Edwards Lifesciences and Medtronic, and support for attending meetings/travel from Boston Scientific. Helge Mollmann participates in a data safety monitoring board/advisory board. Andreas Rück reports grants and personal fees from Boston Scientific and personal fees from Edwards Lifesciences. Won-Kenn Kim reports proctor/speaker fees/advisory board participation for Abbott, Boston Scientific, Edwards Lifesciences, and Meril Life Sciences. Andrea Scotti receives consulting fees from NeoChord Inc. and Edwards Lifesciences. Azeem Latib receives consulting fees of Medtronic advisory board, Abbot advisory board, Boston Scientific advisory board and Edwards consultant. Stefan Toggweiler receives grants from Boston scientific, Novartis and Medtronic, consulting fees from Boston Scientific, Medtronic, Edwards Lifesciences, Biosensors, Shockwave, Teleflex, atHeart Medical, cardiac Dimensions and Polares Medical, lecture fees from ReCor Medical, Sanofi, AstraZeneca and Daiichi Sankyo. Stefan Toggweiler has a leadership/fiduciary role for Hi-D Imaging. Stefan Toggweiler has a stock of Hi-D Imaging. Antonio Mangieri receives a grant from Boston Scientific, lecture fees from Abbot, Boston Scientific, Edwards Lifesiences and Kardia, payment for expert testimony from Abbot and Boston Scientific, support for attending meetings/travel from Innovalve. Christopher U. Meduri reports advisory board participation and proctoring for Boston Scientific, consulting for Medtronic, and advisory board participation for Cardiovalve and Admedus. Tobias Rheude receives lecture fees from AstraZeneca, SIS Medical AG, Abbot Vascular and Translumina, and support for attending meetings/travel from SIS Medical AG. Patrick W. Serruys receives consultant fees from Philips/Volcano, SMT, Novartis, Xeltis and Merillife. The other authors had no conflicts to declare., (© 2024 The Authors.)

Background: The CONtrolled delivery For ImproveD outcomEs with cliNiCal Evidence registry was initiated to characterize the clinical safety and device performance from experienced transcatheter aortic valve implantation (TAVI) centers in Europe and Australia that use the Portico valve to treat patients with severe aortic stenosis. We herein report for the first time the valve performance at 30-day across all implanted valve sizes and the 1-year survival from this registry., Methods: This was a prospective, multicenter, single-arm observational clinical investigation of patients clinically indicated for implantation of a Portico valve in experienced TAVI centers. Patients were treated with a commercially available valve (size 23, 25, 27, or 29 mm) using either the first-generation delivery system (DS) (n = 501) or the second-generation (FlexNav) DS (n = 500). Adverse events were adjudicated by an independent clinical events committee according to Valve Academic Research Consortium-2 criteria. Echocardiographic outcomes were assessed at 30 days by an independent core laboratory, and a survival check was performed at 1 year., Results: We enrolled 1001 patients (82.0 years, 62.5% female, 63.7% New York Heart Association functional class III/IV at baseline) from 27 clinical sites in 8 countries across Europe and one site in Australia. Implantation of a single valve was successful in 97.5% of subjects. Valve hemodynamics at 30 days were substantially improved relative to baseline, with large aortic valve areas and low mean gradients across all implanted valve sizes (aortic valve areas were 1.7 ± 0.4, 1.7 ± 0.5, 1.8 ± 0.5, and 2.0 ± 0.5 cm 2 , and mean gradients were 7.0 ± 2.7, 7.5 ± 4.7, 7.3 ± 3.3, and 6.4 ± 3.3 mmHg for 23, 25, 27, and 29 mm valve sizes, respectively). Across all implanted valve sizes, most patients (77.1%) had no patient-prosthesis mismatch. Death from any cause within 1 year occurred in 13.7% of the patients in the first-generation DS group as compared with 11.0% in the second-generation DS group ( p = 0.2)., Conclusions: The Portico valve demonstrated excellent hemodynamic performance across all valve sizes in a large cohort of subjects implanted in experienced TAVI centers. One-year survival rates were favorable when using both the first-generation and second-generation (FlexNav) DSs in this high-risk cohort., Clinicaltrialsgov Identifier: NCT03752866., (© 2023 The Authors.)

Objectives: The authors sought to evaluate the incidence, predictors, and outcomes of new permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with contemporary self-expanding valves (SEV)., Background: Need for PPI is frequent post-TAVR, but conflicting data exist on new-generation SEV and on the prognostic impact of PPI., Methods: This study included 3,211 patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries (January 2012 to December 2021) who underwent transfemoral TAVR with SEV. Implanted transcatheter heart valves (THV) were Acurate neo (n = 1,090), Acurate neo2 (n = 665), Evolut PRO (n = 1,312), and Evolut PRO+ (n = 144). Incidence and predictors of new PPI and 1-year outcomes were evaluated., Results: New PPI was needed in 362 patients (11.3%) within 30 days after TAVR (8.8%, 7.7%, 15.2%, and 10.4%, respectively, after Acurate neo, Acurate neo2, Evolut PRO, and Evolut PRO+). Independent predictors of new PPI were Society of Thoracic Surgeons Predicted Risk of Mortality score, baseline right bundle branch block and depth of THV implantation, both in patients treated with Acurate neo/neo2 and in those treated with Evolut PRO/PRO+. Predischarge reduction in ejection fraction (EF) was more frequent in patients requiring PPI (P = 0.014). New PPI was associated with higher 1-year mortality (16.9% vs 10.8%; adjusted HR: 1.66; 95% CI: 1.13-2.43; P = 0.010), particularly in patients with baseline EF <40% (P for interaction = 0.049)., Conclusions: New PPI was frequently needed after TAVR with SEV (11.3%) and was associated with higher 1-year mortality, particularly in patients with EF <40%. Baseline right bundle branch block and depth of THV implantation independently predicted the need of PPI., Competing Interests: Funding Support and Author Disclosures Dr Pagnesi has received personal fees from Abbott, AstraZeneca, Boehringer Ingelheim, and Vifor Pharma. Dr Kim is a proctor for Boston Scientific and Abbott Vascular; and has received personal fees from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic and Meril outside the submitted work. Dr Barbanti has served as a consultant for Edwards Lifesciences. Dr De Marco has served as a proctor for Boston Scientific and Kardia. Dr Adamo has received speaker fees from Abbott Vascular and Medtronic. Dr Estévez-Loureiro has served as a consultant for Abbott Vascular and Boston Scientific; and is a proctor for Lifetech Scientific. Dr Conradi has served as an advisory board member for Abbott, Medtronic, JenaValve, and Neovasc; and has received personal fees from Edwards Lifesciences, Boston Scientific, and MicroInterventions. Dr Toggweiler is a proctor for Abbott Vascular, Boston Scientific, Medtronic, and Biosensors/NVT; and is a consultant for Boston Scientific, Medtronic, Biosensors/NVT, Medira, Shockwave, Teleflex, AtHeart, VeoSource, and Equity in Hi-D Imaging. Dr Mylotte is a proctor for Medtronic and Microport. Dr Veulemans has received lecture fees and travel support from Medtronic, Edwards Lifesciences, and Boston Scientific. Dr Søndergaard has received consultant fees and/or institutional research grants from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic and SMT. Dr Wolf is a proctor for Medtronic, Boston Scientific, and Edwards Lifesciences. Dr Pilgrim has received institutional research grants from Boston Scientific, Edwards Lifesciences, and Biotronik; and has received personal fees from Boston Scientific, Biotronik, Abbott, Medtronic, and HighLifeSAS outside the submitted work. Dr Montorfano serves as a proctor for Edwards Lifesciences, Abbott Vascular, and Kardia. Dr Hildick-Smith has served as an adviser or proctor for Edwards Lifesciences, Boston Scientific, and Medtronic. Dr Taramasso is a consultant for Boston Scientific, Abbott Vascular, 4Tech, and CoreMedic; and has received speaker fees from Edwards Lifesciences. Dr Sinning is a proctor for Medtronic and Boston Scientific; has received speaker honoraria from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; and has received research grants from Boston Scientific, Edwards Lifesciences, and Medtronic outside the submitted work. Dr Van Mieghem has received research grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, PulseCath BV, and Daiichi Sankyo; and has received advisory fees from Abbott Vascular, Boston Scientific, Ancora, Medtronic, PulseCath BV, and Daiichi Sankyo. Dr Khogali is a proctor for Medtronic and Boston Scientific. Dr Wood has received grant support from Boston Scientific; and is a consultant for Medtronic. Dr MacCarthy is a proctor for Edwards Lifesciences. Dr Hamm has served on advisory boards for Medtronic. Dr Schäfer is a proctor for Boston Scientific and Medtronic; and has received lecture fees and travel support from both companies. Dr Zeus is a proctor for Medtronic; and has received speaker fees and financial scientific support from Medtronic and Edwards Lifesciences. Dr Naber has received lecture fees from Boston Scientific, Medtronic, and Abbott Vascular; and has served on advisory boards for Boston Scientific and Abbott Vascular. Dr Windecker has received institutional research and educational grants from Abbott Vascular, Amgen, AstraZeneca, Bristol Myers Squibb, Bayer, Biotronik, Boston Scientific, Cardinal Health, CardioValve, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Johnson & Johnson, Medicure, Medtronic, Novartis, Polares, OrPha Suisse, Pfizer, Regeneron, Sanofi, Sinomed, Terumo, and V-Wave. Dr Siqueira is a proctor for Medtronic and Edwards Lifesciences. Dr Sedaghat has received travel grants and support from Medtronic. Dr Metra has received personal fees from Amgen, Vifor Pharma, AstraZeneca, Abbott Vascular, Bayer, Servier, Edwards Therapeutics, Actelion, LivaNova, and Windtree Therapeutics. Dr Latib has served on advisory boards or as a consultant for Medtronic, Boston Scientific, Philips, Edwards Lifesciences. and Abbott Vascular. Dr Mangieri has received an institutional research grant from Boston Scientific; has served on a medical advisory board for Boston Scientific; and has received speaker honoraria from Concept Medical and Boston Scientific. 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.)

Background: Sex-specific characteristics in patients with aortic stenosis and small annuli undergoing transcatheter aortic valve implantation (TAVI) might affect clinical outcomes and hemodynamics., Methods: TAVI-SMALL 2 international retrospective registry included 1378 patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area < 400 mm2) treated with transfemoral TAVI at 16 high-volume centers between 2011 and 2020. Women (n = 1233) were compared with men (n = 145). One-to-one propensity score (PS) matching resulted in 99 pairs. Primary endpoint was incidence of all-cause mortality. Incidence of pre-discharge severe prosthesis-patient mismatch (PPM) and its association with all-cause mortality were investigated. Binary logistic and Cox regression were performed to adjust the treatment effect for PS quintiles., Results: Incidence of all-cause mortality at a median follow-up of 377 days did not differ between sex in the overall (10.3 vs. 9.8%, p = 0.842) and PS-matched (8.5 vs. 10.9%, p = 0.586) populations. After PS matching, pre-discharge severe PPM was numerically higher in women vs. men (10.2 vs. 4.3%), even though no evidence of a difference was found (p = 0.275). Within the overall population, women with severe PPM suffered a higher incidence of all-cause mortality when compared to those with less than moderate PPM (log-rank p = 0.024) and less than severe PPM (p = 0.027)., Conclusions: No difference in all-cause mortality at medium-term follow-up was observed between women and men with aortic stenosis and small annuli undergoing TAVI. Incidence of pre-discharge severe PPM was numerically higher in women than men, and it was associated with increased all-cause mortality in women., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Competing Interests: Funding Support and Author Disclosures Dr Kim has received personal fees from Abbott. Dr Colli is an unpaid consultant for Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Background: The optimal access route in patients with severe peripheral artery disease (PAD) undergoing transcatheter aortic valve replacement (TAVR) remains undetermined., Objectives: This study sought to compare clinical outcomes with transfemoral access (TFA), transthoracic access (TTA), and nonthoracic transalternative access (TAA) in TAVR patients with severe PAD., Methods: Patients with PAD and hostile femoral access (TFA impossible, or possible only after percutaneous treatment) undergoing TAVR at 28 international centers were included in this registry. The primary endpoint was the propensity-adjusted risk of 30-day major adverse events (MAE) defined as the composite of all-cause mortality, stroke/transient ischemic attack (TIA), or main access site-related Valve Academic Research Consortium 3 major vascular complications. Outcomes were also stratified according to the severity of PAD using a novel risk score (Hostile score)., Results: Among the 1,707 patients included in the registry, 518 (30.3%) underwent TAVR with TFA after percutaneous treatment, 642 (37.6%) with TTA, and 547 (32.0%) with TAA (mostly transaxillary). Compared with TTA, both TFA (adjusted HR: 0.58; 95% CI: 0.45-0.75) and TAA (adjusted HR: 0.60; 95% CI: 0.47-0.78) were associated with lower 30-day rates of MAE, driven by fewer access site-related complications. Composite risks at 1 year were also lower with TFA and TAA compared with TTA. TFA compared with TAA was associated with lower 1-year risk of stroke/TIA (adjusted HR: 0.49; 95% CI: 0.24-0.98), a finding confined to patients with low Hostile scores (P interaction  = 0.049)., Conclusions: Among patients with PAD undergoing TAVR, both TFA and TAA were associated with lower 30-day and 1-year rates of MAE compared with TTA, but 1-year stroke/TIA rates were higher with TAA compared with TFA., Competing Interests: Funding Support and Author Disclosures Dr Palmerini has received speaker fees from Edwards Lifesciences and Medtronic. Dr Saia has received consulting and lecture fees from Abbott, Edwards Lifesciences, and Medtronic. Dr Kim has received personal fees from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, Merill Life Sciences, and Shockwave Medical. Dr Søndergaard has received consulting fees and/or institutional research grants from Abbott, Boston Scientific, Medtronic, and Sahajanand Medical Technologies. Dr Burzotta has received speaker fees from Abiomed, Abbott, Medtronic, and Terumo. Dr Romagnoli has received speaker fees by Abbott Vascular, Abiomed, and Medtronic. Dr Van Mieghem has received research grant support from Abbott Vascular, Biotronik, Boston Scientific, Medtronic, Edwards Lifesciences, Abiomed, PulseCath BV, and Daiichi Sankyo. Dr Pilgrim has received research grants to his institution from Boston Scientific, Biotronik, and Edwards Lifesciences; and honoraria from Biotronik, Boston Scientific, Medtronic, Abbott, and HighLife SAS. Dr Adam has received personal and proctoring fees from Abbott, Boston Scientific, Edwards Lifesciences, JenaValve, and Medtronic (during the conduct of the study). Dr Di Mario has received research grants to his institution from Abbott, Amgen, Boston Scientific, Chiesi, Daiichi Sankyo, Edwards Lifesciences, and Volcano Philips. Dr Toggweiler has served as a proctor/consultant for Medtronic, Edwards Lifesciences, Biosensors, Boston Scientific, and Abbott Vascular; has served consultant for Medira, AtHeart Medical, Veosource, Shockwave, Teleflex, and Polares Medical; has received institutional research grants from Biosensors, Boston Scientific, and Fumedica; and holds equity in Hi-D Imaging. Dr Testa has received consulting fees from and served as a proctor Abbott, Boston Scientific, Medtronic, and Merrill. Dr Berti has served as a proctor for Edwards Lifesciences, Abbott, and Boston Scientific. Dr Ancona has received consultant fees from Abbott. Dr Montorfano has received proctor fees from Abbott, Edwards Lifesciences, and Boston Scientific. Dr Castriota has received proctoring fees from Abbott and Medtronic. Dr Petronio has received consultant and research funds from Medtronic, Boston Scientific, and Abbott. Dr Barbanti has served as a consultant for Medtronic, Edwards Lifesciences, and Boston Scientific. Dr Tamburino has received speaker honoraria from Abbott and Medtronic. Dr Nickenig has received lecture or advisory board honoraria from Abbott, Amarin, AstraZeneca, Bayer, Berlin Chemie, Biosensus, Biotronik, Bristol Myers Squibb, Boehringer Ingelheim, CardioValve, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, and Sanofi; owns stock options with Beren, Cardiovalve; has served in clinical trials with Abbott, AstraZeneca, Bayer, Berlin Chemie, Biosensus, Biotronik, Bristol Myers Squibb, Boehringer Ingelheim, CardioValve, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, and Sanofi; and has received research funding from the Deutsche Forschungsgemeinschaft, the Bundeministerium für Bildung und Forschun, the European Union, Abbott, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Edwards Lifesciences, Medtronic, Novartis, and Pfizer. Dr Stefanini has received speaker fees from Abbott Vascular, Boston Scientific, and Pfizer/Bristol Myers Squibb; research grants to his institution from Boston Scientific. Dr Latib has served as a consultant for Abbott, Medtronic, Edwards Lifesciences, Boston Scientific, Neovasc, Shifamed, and Philips. Dr Porto has received consulting or speaker fees from Biotronik, Abiomed, Medtronic, Terumo, Philips, Sanofi, Amgen, Daiichi Sankyo, AstraZeneca, and Bayer, not related to this work. Dr Grube has served on the Speakers Bureau/Scientific Advisory Board for Medtronic, Boston Scientific, JenaValve, and High Life; and owns equity interest in Millipede, Pi-Cardia, Ancora, Laminar, ReNiva Medical, and Shockwave. Dr Stone has received speaker honoraria from Medtronic, Pulnovo, and Infraredx; has served as a consultant for Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Cardiomech, Gore, Amgen, and Adona Medical; owns equity/options in Ancora, Cagent, Applied Therapeutics, the Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and Xenter; has a daughter who is an employee at Medtronic; and his employer (Mount Sinai Hospital) has received research support from Abbott, Abiomed, Bioventrix, Cardiovascular Systems, Philips, Biosense Webster, Shockwave, Vascular Dynamics, and V-wave. 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.)

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

Background: Outcomes after transcatheter aortic valve replacement (TAVR) and infectious diseases may vary according to sex., Methods: This multicentre study aimed to determine the sex differences in clinical characteristics, management, and outcomes of infective endocarditis (IE) after TAVR. A total of 579 patients (217 women, 37.5%) who had the diagnosis of definite IE following TAVR were included retrospectively from the Infectious Endocarditis After TAVR International Registry., Results: Women were older (80 ± 8 vs 78 ± 8 years; P = 0.001) and exhibited a lower comorbidity burden. Clinical characteristics and microbiological profiles were similar between men and women, but culture-negative IE was more frequent in women (9.9% vs 4.3%; P = 0.009). A high proportion of patients had a clinical indication for surgery (54.4% in both groups; P = 0.99), but a surgical intervention was performed in a minority of patients (women 15.2%, men 20.3%; P = 0.13). The mortality rate at index IE hospitalisation was similar in both groups (women 35.4%, men 31.7%; P = 0.37), but women exhibited a higher mortality rate at 2-year follow-up (63% vs 52.1%; P = 0.021). Female sex remained an independent risk factor for cumulative mortality in the multivariable analysis (adjusted HR 1.28, 95% CI 1.02-1.62; P = 0.035). After adjustment for in-hospital events, surgery was not associated with better outcomes in women., Conclusions: There were no significant sex-related differences in the clinical characteristics and management of IE after TAVR. However, female sex was associated with increased 2-year mortality risk., (Copyright © 2022 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to evaluate outcomes of real-world patients with aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) with the 34 mm Evolut R (Medtronic, Minneapolis, Minnesota)., Background: Larger aortic annulus has been associated with increased incidence of paravalvular leaks (PVLs) after TAVR. However, little is known, so far, about the performance of the 34 mm Evolut R in this setting., Methods: From the multicenter, international, retrospective Horizontal Aorta in Transcatheter Self-expanding Valves (HORSE) registry, including patients who underwent TAVR for native severe AS, we selected patients treated with the 34 mm Evolut R evaluating procedural characteristics and VARC-2 defined device success. We also compared 34 mm Evolut R with other Evolut R sizes., Results: Among the 4434 patients included in the registry, 572 (13%) received the 34 mm Evolut R valve. Mean age was 80.8 ± 6.5 years and the median STS PROM score was 4 [interquartile range 2-6]. Device success was achieved in 87.4% with 7.7% of PVLs; moreover, the rate of permanent pacemaker implantation (PPMI) was 22.4%. Patients who underwent 34 mm Evolut R implantation experienced more in-hospital permanent pacemaker implantation (22.4% vs. 15%; p < 0.001). At multivariate analysis, 34 mm Evolut R did not affect device success (OR: 0.81 [0.60-1.09]; p = 0.151). Device success was consistent with other THVs sizes (87.4% vs. 89.6%; p = 0.157)., Conclusions: THV replacement in patients requiring 34 mm Evolut R has an acceptable performance. Compared to other Medtronic sizes it demonstrated to be comparable in terms of device success, despite an increased rate of pacemaker implantation., (Copyright © 2022 Elsevier B.V. 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.)

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

Objectives: Malpositioning of transcatheter heart valves increases the risk of procedural failure. For the ACURATE system, inadvertent movement of the prosthesis to a varying extent is sometimes observed upon full release, but the incidence, mechanisms, and clinical impact of such valve micro-dislodgement (VMD) are poorly understood. The aim of the present study was to assess the incidence, predictors, and clinical outcomes of VMD in an all-comers population that underwent transcatheter aortic valve implantation (TAVI) with the ACURATE neo2 prosthesis (NEO2)., Methods: This was a retrospective analysis of 448 consecutive patients who underwent transfemoral TAVI with NEO2 at our institution. VMD was defined as displacement ≥2 mm between the initial position and immediately after valve release as measured on fluoroscopy at the non-coronary cusp. The initial valve position prior to step 2 was categorized using the radiopaque marker band (RMB) relative to the annular plane. In addition, further anatomical and procedural characteristics were assessed., Results: A total of 68 (15.2%) cases with VMD were identified. A larger cover index, higher RMB position, partial detachment of the lower crown, and severe parallax prior to deployment were independent predictors of VMD, whereas a position of the delivery system in the outer curvature was protective against VMD. Among patients with VMD, the rates of valvular malpositioning and thus technical failure (VARC-3) were higher, but mean transprosthetic gradients were lower., Conclusions: VMD occurs in a notable proportion of transfemoral TAVI cases with NEO2 and is associated with more frequent technical failure of the procedure., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Background: Direct comparisons of latest-generation balloon-expandable versus self-expanding transcatheter heart valves (THV) are scarce. To compare outcomes after transcatheter aortic valve replacement (TAVR) with SAPIEN 3 Ultra (Ultra) versus Evolut R or Pro (Evolut) THVs., Methods: 1612 consecutive patients undergoing TAVR with either Ultra (n = 616) or Evolut (n = 996) were included. After propensity score matching (PSM), 467 and 205 matched pairs were identified in the entire cohort and with latest-generation THVs, respectively. Outcomes were investigated up to 30 days after TAVR., Results: After PSM, baseline characteristics were comparable in the entire cohort (n = 934). Device success (92.7% vs. 87.6%; p = 0.011) and need for permanent pacemaker implantation (PPI) (15.2% vs. 8.4%; p = 0.002) were higher for Evolut compared with Ultra. Elevated gradients (≥20 mm Hg) were less frequent (1.6% vs. 10.4%; p < 0.001), whereas rates of ≥ moderate paravalvular leakage (PVL II+) were more frequent for Evolut compared with Ultra (3.7% vs. 1.3%; p = 0.019). With latest-generation THVs (n = 410), device success was comparable (93.2% vs. 89.8%; p = 0.216), whereas the need for PPI was higher for Evolut Pro compared with Ultra (15.6% vs. 9.8%; p = 0.075). Elevated gradients were less frequent (0% vs. 8%; p < 0.001), whereas rates of PVL II+ were more frequent for Evolut compared with Ultra (5.4% vs. 1.5%; p = 0.028)., Conclusions: Device success rates were high with both THV platforms with low rates of adverse events up to 30 days after TAVR. Compared with Ultra, Evolut was associated with higher pacemaker rates as well as PVL II+, but with less elevated gradients., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Background: Despite excellent procedural results in a broad clinical population, certain anatomical or clinical conditions are still challenging for transcatheter aortic valve replacement (TAVI). Whether the adherence to the instructions for use (IFU) or the use of a clinically suitable device is a prerequisite for procedural success has not been well characterized., Aims: The anatomical and clinical suitability of new-generation transcatheter heart valves (THV) was evaluated in an all-comers population (n = 540) at a high-volume center., Methods: Conformity with anatomical IFU criteria was evaluated in each implanted THV. In addition, the suitability of the implanted THV was verified in each case according to clinical and anatomical criteria, which had been previously defined according to the results of an international survey including 20 renowned TAVI operators. Furthermore, criteria of clinical suitability and adherence to IFU of each THV were applied to the overall cohort to analyze the proportion of patients in whom the use of the respective THV would have been judged to be unsuitable or off-label., Results: An off-label use of THV based on anatomical considerations was found in 20% of all procedures, whereas the implantation of a THV deemed to be clinically unsuitable was noted in 16.3% of all procedures. Clinical suitability and conformity with IFU were present to a varying extent across the THV systems. Neither clinical suitability, nor conformity with IFU were associated with device failure or periprocedural mortality. On multivariable analysis, aortic tortuosity, mean transaortic gradient and ascending aorta diameter were identified as independent predictors of device failure (VARC-3)., Conclusions: Off-label TAVI and the use of clinically unsuitable THVs were common, but did not affect procedural outcomes. The variety of clinical and anatomical coverage of the different THV systems emphasizes the importance of an individualized THV selection., (Copyright © 2021 Elsevier B.V. All rights reserved.)

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

Objectives: To investigate the risk of haematologic and solid organ malignancies in patients with haemorrhagic fever with renal syndrome (HFRS) compared with the general population., Methods: This propensity-score-matched cohort study was conducted using data collected from the Korean national health insurance service (NHIS) between January 2003 and December 2017. The HFRS cohort included 5888 newly diagnosed cases of HFRS, and 412,804 general participants from the NHIS database were included as the control cohort. The incidence rate of malignancies was assessed and compared between the HFRS and control cohorts., Results: There were 64 cases of haematologic malignancy in 236,286 person-years of observation, and 1245 cases of solid organ cancer in 209,333 person-years. The risks of haematologic malignancy and solid organ cancer were significantly higher in the HFRS cohort [adjusted hazards ratio (aHR) 4.10, 95% confidence interval (CI) 2.36-7.14] than the control cohort [aHR 2.97, 95% CI 2.60-3.38). In subgroup analysis, the HFRS cohort was associated with high hazard ratios for leukaemia and non-Hodgkin lymphoma. The HFRS cohort also had increased aHRs for all types of solid organ cancer., Conclusions: Patients with HFRS are at increased risk of both haematologic and solid organ malignancies compared with the general population, and this increased proportionally over time. Careful monitoring for malignancy after the onset of HFRS may be necessary., (Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Background: Compared with invasive fractional flow reserve (FFR), coronary CT angiography (cCTA) is limited in detecting hemodynamically relevant lesions. cCTA-based FFR (CT-FFR) is an approach to overcome this insufficiency by use of computational fluid dynamics. Applying recent innovations in computer science, a machine learning (ML) method for CT-FFR derivation was introduced and showed improved diagnostic performance compared to cCTA alone. We sought to investigate the influence of stenosis location in the coronary artery system on the performance of ML-CT-FFR in a large, multicenter cohort., Methods: Three hundred and thirty patients (75.2% male, median age 63 years) with 502 coronary artery stenoses were included in this substudy of the MACHINE (Machine Learning Based CT Angiography Derived FFR: A Multi-Center Registry) registry. Correlation of ML-CT-FFR with the invasive reference standard FFR was assessed and pooled diagnostic performance of ML-CT-FFR and cCTA was determined separately for the following stenosis locations: RCA, LAD, LCX, proximal, middle, and distal vessel segments., Results: ML-CT-FFR correlated well with invasive FFR across the different stenosis locations. Per-lesion analysis revealed improved diagnostic accuracy of ML-CT-FFR compared with conventional cCTA for stenoses in the RCA (71.8% [95% confidence interval, 63.0%-79.5%] vs. 54.8% [45.7%-63.8%]), LAD (79.3 [73.9-84.0] vs. 59.6 [53.5-65.6]), LCX (84.1 [76.0-90.3] vs. 63.7 [54.1-72.6]), proximal (81.5 [74.6-87.1] vs. 63.8 [55.9-71.2]), middle (81.2 [75.7-85.9] vs. 59.4 [53.0-65.6]) and distal stenosis location (67.4 [57.0-76.6] vs. 51.6 [41.1-62.0])., Conclusion: In a multicenter cohort with high disease prevalence, ML-CT-FFR offered improved diagnostic performance over cCTA for detecting hemodynamically relevant stenoses regardless of their location., Competing Interests: Declaration of competing interest Dr. Renker has received speaker fees from Abbott. Dr. Baumann has received consulting fees from Phillips Volcano. Dr. Tesche has received research support and honoraria for speaking from Siemens. Dr. Kim received proctor/speaker fees from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, Meril. Dr. Nieman reports unrestricted institutional support from Siemens Healthineers, Bayer, GE, and Heartflow Inc., and consultancy honoraria from Siemens Medical Solutions USA. Dr. Persson reports on institutional support from Siemens Healthineers. Dr. Schoepf has received grants and/or personal fees from Bayer, Bracco, Elucid BioImaging, GE, Guerbet, HeartFlow Inc., Keya Medical, and Siemens. All other authors declare that they have no financial disclosures., (Copyright © 2021 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to determine if percutaneous coronary intervention (PCI) prior to transcatheter aortic valve replacement (TAVR) in patients with significant coronary artery disease would produce noninferior clinical results when compared with no PCI (control arm)., Background: PCI in patients undergoing TAVR is not without risk, and there are no randomized data to inform clinical practice., Methods: Patients with severe symptomatic aortic stenosis and significant coronary artery disease with Canadian Cardiovascular Society class ≤2 angina were randomly assigned to receive PCI or no PCI prior to TAVR. The primary endpoint was a composite of all-cause death or rehospitalization at 1 year. Noninferiority testing (prespecified margin of 7.5%) was performed in the intention-to-treat population., Results: At 17 centers, 235 patients underwent randomization. At 1 year, the primary composite endpoint occurred in 48 (41.5%) of the PCI arm and 47 (44.0%) of the no-PCI arm. The requirement for noninferiority was not met (difference: -2.5%; 1-sided upper 95% confidence limit: 8.5%; 1-sided noninferiority test P = 0.067). On analysis of the as-treated population, the difference was -3.7% (1-sided upper 95% confidence limit: 7.5%; P = 0.050). Mortality was 16 (13.4%) in the PCI arm and 14 (12.1%) in the no-PCI arm. At 1 year, there was no evidence of a difference in the rates of stroke, myocardial infarction, or acute kidney injury, with higher rates of any bleed in the PCI arm (P = 0.021)., Conclusions: Observed rates of death and rehospitalization at 1 year were similar between PCI and no PCI prior to TAVR; however, the noninferiority margin was not met, and PCI resulted in a higher incidence of bleeding. (Assessing the Effects of Stenting in Significant Coronary Artery Disease Prior to Transcatheter Aortic Valve Implantation; ISRCTN75836930)., Competing Interests: Funding Support and Author Disclosures The ACTIVATION trial was funded by Edwards Lifesciences and Boston Scientific. Drs Clayton and Dodd have received reimbursement from King’s College London as independent statisticians for performing statistical analysis. Dr Morice is the CEO of Cardiovascular European Research Center CTU. Dr Meneveau has received consulting fees, speaker fees, and project funding from Bayer HealthCare and BMS/Pfizer; has received speaker fees from AstraZeneca and Boehringer Ingelheim; and has received consulting fees from Abbott and Terumo. Dr Banning has received institutional grant support for an educational fellowship from Boston Scientific and has been partially funded by the NHS Oxford Biomedical Research Centre. Dr Thomas is an employee of Edwards Lifesciences. Dr Prendergast has received unrestricted educational and research grants from Edwards Lifesciences; has received speaker/consultancy fees from Edwards Lifesciences, Abbott, and Anteris. Dr Hildick-Smith has served as Proctor/Advisory to Boston Scientific, Medtronic, and Edwards. Dr Redwood has served as a proctor and received speaker fees from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Horizontal aorta (HA) is an anatomical feature that can pose significant technical challenges for the successful positioning of the bioprosthetic valve during transcatheter aortic valve replacement (TAVR). Physiological range of aortic angle (AA) is unknown; hence there is no cutoff AA for classifying HA. Moreover, patient characteristics predicting HA are under-investigated., Methods: This was a retrospective analysis of prospective collected data from 16 heart valve centers in Europe. The study utilized a common dataset with a priori agreed-upon definitions and variables. Eligible patients underwent TAVR between 2014 and 2020 and had multidetector computed tomographic imaging data available for determining the AA. The analysis described the distribution of AA and potential predictors of HA. Inter-center variability was also explored., Results: For 4022 patients analyzed, the mean AA ± standard deviation was 49.4° ± 9.4° (median 49°, inter-quartile range [IQR] 12°, range 18-90°). There was no significant difference in mean AA between men and women (49.4° ± 9.1° vs. 49.6° ± 9.3°, respectively; p = 0.53); therefore, 49.4° was accepted as the cutoff value for HA in subsequent analyses. Covariates significantly associated with HA included age (odds ratio [OR]: 1.02, 95% confidence interval [CI]: 1.01-1.04, p < 0.001), body mass index (OR: 1.06, 95% CI: 1.05-1.08, p < 0.01), previous cardiac surgery (OR: 0.58, 95% CI: 0.45-0.75, p < 0.001), and porcelain aorta (OR: 0.66, 95% CI: 0.52-0.85, p = 0.001). Some inter-center variability was observed., Conclusions: We defined 49.4° as the mean AA, and also associated predictors of HA in a large case series of patients with severe aortic stenosis candidates for TAVR., Competing Interests: Declaration of Competing Interest None., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Objectives: The aim of this study was to characterize the feasibility of coronary angiography (CA) and percutaneous coronary intervention (PCI) in acute settings among patients who have undergone transcatheter aortic valve replacement (TAVR)., Background: Impaired coronary access after TAVR may be challenging and particularly in acute settings could have deleterious consequences., Methods: In this international registry, data from patients with prior TAVR requiring urgent or emergent CA were retrospectively collected. A total of 449 patients from 25 sites with acute coronary syndromes (89.1%) and other acute cardiovascular situations (10.9%) were included., Results: Success rates were high for CA of the right coronary artery (98.3%) and left coronary artery (99.3%) and were higher among patients with short stent-frame prostheses (SFPs) than in those with long SFPs for CA of the right coronary artery (99.6% vs 95.9%; P = 0.005) but not for CA of the left coronary artery (99.7% vs 98.7%; P = 0.24). PCI of native coronary arteries was successful in 91.4% of cases and independent of valve type (short SFP 90.4% vs long SFP 93.4%; P = 0.44). Guide engagement failed in 6 patients, of whom 3 underwent emergent coronary artery bypass grafting and another 3 died in the hospital. Among patients requiring revascularization of native vessels, independent predictors of 30-day all-cause mortality were prior diabetes, cardiogenic shock, and failed PCI but not valve type or success of coronary engagement., Conclusions: CA or PCI after TAVR in acute settings is usually successful, but selective coronary engagement may be more challenging in the presence of long SFPs. Among patients requiring PCI, prior diabetes, cardiogenic shock, and failed PCI were predictors of early mortality., Competing Interests: Funding Support and Author Disclosures Dr Kim has received proctor and speaker fees from Boston Scientific, Abbott, Edwards Lifesciences, Medtronic, and Meril Lifesciences. Dr Ludwig has received travel compensation from Edwards Lifesciences. Dr Möllmann has received proctor fees and/or speaker honoraria from Abbott, Biotronik, Edwards Lifesciences, and Boston Scientific. Dr Leuschner has received speaker honoraria from Medtronic. Dr Amat-Santos is a proctor for Boston Scientific; Dr Dabrowski has received proctor fees from Boston Scientific; and has received speaker fees from Boston Scientific, Abbott, Edwards Lifesciences, and Medtronic. Dr Rudolph has received proctor fees and/or lecture honoraria from Boston Scientific, Edwards Lifesciences, Medtronic, and Abbott. Dr Toggweiler is a consultant and/or proctor for New Valve Technology/Biosensors, Boston Scientific, Abbott, Medtronic, Carag, and Medira; has received institutional research grants from Boston Scientific and Fumedica; and holds equity in Hi-D Imaging. Dr Frank is a consultant for Edwards Lifesciences and Medtronic; and has received an institutional research grant from Edwards Lifesciences. Dr Webb is a consultant to Edwards Lifesciences; and has received research grants from Abbott, Boston Scientific, and Medtronic. Dr Barbanti is a consultant for Edwards Lifesciences; and an advisory board member for Medtronic. Dr Pilgrim has received research grants to the institution from Biotronik and Boston Scientific; has received speaker fees from Biotronik and Boston Scientific; is a consultant for HighLife SAS; and is a proctor for Medtronic and Boston Scientific. Dr Seiffert is a consultant for JenaValve and Boston Scientific; has received travel compensation from Abbott Vascular, Edwards Lifesciences, JenaValve, Boston Scientific, and Biotronik; and has received speaker honoraria from Medtronic. Dr Werner is a proctor for Medtronic; and has received speaker honoraria from Edwards Lifesciences, Boston Scientific, Medtronic. Dr Allali has received proctor and speaker fees from Boston Scientific. Dr Makkar has received consultant fees from Abbott; and has received research grants and consulting and speaker fees from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific. Dr Leuschner has received speaker honoraria from Medtronic. Dr Nef has received proctor or speaker honoraria from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Hamm is an advisory board member for Medtronic. Dr Sinning has received research grants from Boston Scientific, Edwards, and Medtronic; and has received speaker honoraria from Abbott, Abiomed, Boston Scientific, Edwards, and Medtronic. 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.)