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Background: Transcatheter aortic valve implantation (TAVI) is increasingly being used in younger patients and those with lower peri-procedural risk, meaning more patients will live long enough to experience structural valve deterioration (SVD) of the bioprosthesis, indicating repeated TAVI. Experience of repeated TAVI-transcatheter heart valve (THV) implantation into an index THV is limited. This registry aims to assess the peri-procedural and short-term safety, efficacy and durability of repeated TAVI., Methods: The ReTAVI Prospective observational registry is an investigator-initiated, multicentre, international, prospective registry of patients undergoing repeated TAVI using balloon-expandable SAPIEN prosthesis to evaluate procedural and short-term safety, efficacy and durability as well as anatomical and procedural factors associated with optimal results. The registry will enrol at least 150 patients across 60 high-volume centres. Patients must be ≥18 years old, have had procedural success with their first TAVI, have index THV device failure, intend to undergo repeated TAVI and be considered suitable candidates by their local Heart Team. All patients will undergo a 30-day and 12-month follow-up. The estimated study completion is 2025., Conclusions: The registry will collect pre-, peri-, postoperative and 12-months data on patients undergoing repeated TAVI procedures with THVs for failure of the index THV and determine VARC-3-defined efficacy and safety at 30 days and functional outcome at 12 months. The registry will expand existing data sets and identify patient characteristics/indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis., (© 2024 The Author(s). European Journal of Clinical Investigation published by John Wiley & Sons Ltd on behalf of Stichting European Society for Clinical Investigation Journal Foundation.)

Background: About half of patients with severe aortic stenosis present with concomitant coronary artery disease. The optimal timing of percutaneous coronary intervention (PCI) and transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis and concomitant coronary artery disease remains unknown., Study Design: The TAVI PCI trial is a prospective, international, multicenter, randomized, 2-arm, open-label study planning to enroll a total of 986 patients. It is designed to investigate whether the strategy "angiography-guided complete revascularization after (within 1-45 days) TAVI" is noninferior to the strategy "angiography-guided complete revascularization before (within 1-45 days) TAVI" using the Edwards SAPIEN 3 or 3 Ultra Transcatheter Heart Valve in patients with severe aortic stenosis and concomitant coronary artery disease. Patients are randomized in a 1:1 ratio to one of the 2 treatment strategies. The primary end point is a composite of all-cause death, nonfatal myocardial infarction, ischemia-driven revascularization, rehospitalization (valve- or procedure-related including heart failure), or life-threatening/disabling or major bleeding at 1 year., Conclusions: The TAVI PCI trial tests the hypothesis that the strategy "PCI after TAVI" is noninferior to the strategy "PCI before TAVI" in patients with severe aortic stenosis and concomitant coronary artery disease., Competing Interests: Declaration of competing interest TAVI PCI is supported as investigator-initiated research by Edwards Lifesciences (THV-I20-061)., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Among low-risk patients with severe, symptomatic aortic stenosis who are eligible for both transcatheter aortic-valve implantation (TAVI) and surgical aortic-valve replacement (SAVR), data are lacking on the appropriate treatment strategy in routine clinical practice., Methods: In this randomized noninferiority trial conducted at 38 sites in Germany, we assigned patients with severe aortic stenosis who were at low or intermediate surgical risk to undergo either TAVI or SAVR. Percutaneous- and surgical-valve prostheses were selected according to operator discretion. The primary outcome was a composite of death from any cause or fatal or nonfatal stroke at 1 year., Results: A total of 1414 patients underwent randomization (701 to the TAVI group and 713 to the SAVR group). The mean (±SD) age of the patients was 74±4 years; 57% were men, and the median Society of Thoracic Surgeons risk score was 1.8% (low surgical risk). The Kaplan-Meier estimate of the primary outcome at 1 year was 5.4% in the TAVI group and 10.0% in the SAVR group (hazard ratio for death or stroke, 0.53; 95% confidence interval [CI], 0.35 to 0.79; P<0.001 for noninferiority). The incidence of death from any cause was 2.6% in the TAVI group and 6.2% in the SAVR group (hazard ratio, 0.43; 95% CI, 0.24 to 0.73); the incidence of stroke was 2.9% and 4.7%, respectively (hazard ratio, 0.61; 95% CI, 0.35 to 1.06). Procedural complications occurred in 1.5% and 1.0% of patients in the TAVI and SAVR groups, respectively., Conclusions: Among patients with severe aortic stenosis at low or intermediate surgical risk, TAVI was noninferior to SAVR with respect to death from any cause or stroke at 1 year. (Funded by the German Center for Cardiovascular Research and the German Heart Foundation; DEDICATE-DZHK6 ClinicalTrials.gov number, NCT03112980.)., (Copyright © 2024 Massachusetts Medical Society.)

Background: Data on systemic inflammatory response syndrome (SIRS) after transcatheter aortic valve implantation (TAVI) are scarce and limited to small cohorts. We aimed to investigate its incidence and mid-term impact in a large cohort of TAVI patients., Methods: From January 2018 to December 2020, 717 patients with severe aortic valve stenosis undergoing TAVI were included. SIRS was defined as fulfilling at least two of the following criteria within 48 h from the procedure: leucocyte count >12.0 or <4.0 × 10 9 /l, respiratory rate > 20 breaths per minute or PaCO 2  ≤ 4.3 kPa/32 mmHg, heart rate > 90 beats per minute and temperature > 38.0 °C or <36.0 °C. Clinical endpoints were 1-year rehospitalization for chronic heart failure (CHF) and 2-years all-cause mortality. Event rates during follow-up were calculated as Kaplan-Meier estimates., Results: SIRS developed in 56.3 % (404/717) of patients after TAVI. SIRS occurred more frequently in patients with post-dilatation (SIRS 34.7 % (140/404) vs. no SIRS 23.3 % (73/313); p < 0.001) and major vascular complications (SIRS 16.1 % (65/404) vs. no SIRS 8.6 % (27/313); p = 0.004). Further, ICU days were more in patients who developed SIRS (SIRS 1.56 ± 1.50 days vs. no SIRS 1.22 ± 1.02 days; p = 0.001). At 2-years, all-cause mortality in the entire population was 23.9 %. However, there was no difference in CHF at 1-year (5.9 % vs. 4.1 %; log-rank = 0.347) nor in all-cause mortality at 2-years (22.0 % vs. 26.2 %; log-rank = 0.690) between the groups., Conclusions: SIRS is a common finding after TAVI, which may prolong hospital stay but is without effect on mortality during 2-years follow-up., Competing Interests: Declaration of competing interest Costanza Pellegrini reports receiving a personal research grant from Else Kröner Fresenius not related to the current work. Stiftung. Tobias Rheude received lecture fees from SIS Medical AG and AstraZeneca and travel support from SIS Medical AG (not related to the current work). Stefan Holdenrieder reports receiving research funding or honoraria from Roche Diagnostics, Bristol Myers Squibb, Merck KgaA, Sysmex Inostics and Volition SPRL. Michael Joner reports lecture fees and research grants from Edwards Lifesciences, Cardiac Dimensions, Infraredx, and Boston Scientific; is a consultant for Biotronik, Boston Scientific, Cardiac Dimensions, and Shockwave Medical; has received honoraria from Abbott, AstraZeneca, Biotronik, Boston Scientific, Edwards Lifesciences, Recor, Shockwave Medical, and Orbus Neich; and is a Member of the Board of Biotronik and Shockwave Medical. The other authors report no conflict of interest., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background:  We aimed to compare hemodynamic performance of the Avalus (Medtronic) and the Perimount Magna Ease (PME, Edwards Lifesciences) bioprosthesis up to 5 years by serial echocardiographic examinations., Methods:  In patients undergoing aortic valve replacement, 58 received PME prostheses between October 2007 and October 2008, and another 60 received Avalus prostheses between October 2014 and November 2015. To ensure similar baseline characteristics, we performed a propensity score matching based on left ventricular ejection fraction, age, body surface area, and aortic annulus diameter measured by intraoperative transesophageal echocardiography. Thereafter, 48 patients remained in each group. Mean age at operation was 67 ± 6 years and mean EuroSCORE-II was 1.7 ± 1.1. Both values did not differ significantly between the two groups., Results:  At 1 year the mean pressure gradient (MPG) was 15.4 ± 4.3 mm Hg in the PME group and 14.7 ± 5.1 mm Hg in the Avalus group ( p  = 0.32). The effective orifice area (EOA) was 1.65 ± 0.45 cm 2 in the PME group and 1.62 ± 0.45 cm 2 in the Avalus group ( p  = 0.79). At 5 years the MPG was 16.6 ± 5.1 mm Hg in the PME group and 14.7 ± 7.1 mm Hg in the Avalus group ( p  = 0.20). The EOA was 1.60 ± 0.49 cm 2 in the PME group and 1.51 ± 0.40 cm 2 in the Avalus group ( p  = 0.38). Five-year survival was 88% in the PME group and 91% in the Avalus group ( p  = 0.5). In the PME group, there were no reoperations on the aortic valve, whereas in the Avalus group three patients required a reoperation due to endocarditis., Conclusion:  Both bioprostheses exhibit similar hemodynamic performance during a 5-year follow-up., Competing Interests: R.L.: Lecture fees, royalties, and serving on an advisory board for Medtronic; lecture fees and serving on an advisory board for LivaNova; and lecture fees, shares, and serving on an advisory board for Highlife; V.K.: Serving on an advisory board for Medtronic., (Thieme. All rights reserved.)

Aortic valve stenosis is one of the most frequent valvular heart diseases requiring treatment in industrialized countries. The symptom onset is associated with a significantly increased mortality, so that there is a clear indication for treatment in patients with severe, symptomatic aortic valve stenosis; however, data on the optimal treatment of patients with asymptomatic aortic valve stenosis are scarce. Smaller studies in the field of cardiac surgery suggest that early surgical valve replacement is superior to a conservative approach. For this reason, the results of additional adequately powered randomized trials are awaited with great interest. In this year numerous long-term results from randomized comparisons of the two available treatment options (surgical versus transcatheter aortic valve replacement) were published, which will further guide the heart team to find the best treatment approach for each individual., (© 2024. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Background: The risks of prefrail and frail women undergoing transcatheter aortic valve replacement (TAVR) have not been fully examined. The aim of the analysis was to assess the prognostic impact of prefrailty and frailty in women undergoing TAVR., Methods: Women at intermediate or high surgical risk with severe aortic stenosis undergoing TAVR from the prospective multicentre WIN-TAVI (Women's International Transcatheter Aortic Valve Implantation) registry were stratified based on the number of Fried frailty criteria (weight loss, exhaustion, low physical activity, slow gait, weakness) met: nonfrail (no criteria), prefrail (1 or 2 criteria), or frail (3 or more criteria). The primary outcome at 1 year was the Valve Academic Research Consortium 2 (VARC-2) efficacy end point, a composite of mortality, stroke, myocardial infarction, hospitalisation for valve-related symptoms or heart failure, and valve-related dysfunction; secondary outcomes included the composite of VARC-2 life-threatening or major bleeding., Results: Out of 1019 women, 297 (29.1%) met at least 1 frailty criterion: 264 (25.9%) had prefrailty and 33 (3.2%) frailty. The 1-year risk of the primary outcome was significantly higher in prefrail and frail (20.2%) than in nonfrail (14.9%) women (adjusted hazard ratio [aHR] 1.51, 95% confidence interval [CI] 1.07-2.12). The risk of VARC-2 life-threatening or major bleeding was higher in prefrail or frail (19.9%) than in nonfrail (10.0%) women (aHR 2.06, 95% CI 1.42-2.97). These risks were consistently increased in the prefrail and frail groups assessed separately., Conclusions: In women undergoing TAVR, the presence of prefrailty or frailty conferred an increased risk of the VARC-2 efficacy end point and of VARC-2 life-threatening or major bleeding., (Copyright © 2023 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Background: Knowledge about atrial functional tricuspid regurgitation (afTR) in transcatheter aortic valve replacement (TAVR) patients is scarce., Objectives: The aim of the study was to analyze the association between the entity and the development of tricuspid regurgitation (TR) in patients undergoing TAVR for aortic stenosis and concomitant TR., Methods: We analyzed patients undergoing TAVR for severe aortic stenosis from January 2013 to December 2020 and concomitant at least moderate TR at baseline. afTR was defined as enlargement of the right atrium in relation to the right ventricle. TR development after TAVR and 3-year all-cause mortality were evaluated., Results: Out of 3,474 TAVR patients, we identified 420 patients with concomitant at least moderate TR. A total of 363 patients were included in the study, with 178 patients stratified in the afTR and 185 in the non-afTR group based on a receiver-operating characteristic curve cutoff of 1.132 of the right atrial/right ventricular area ratio. TR improvement after TAVR was observed in significantly less patients with afTR compared with non-afTR (31.1% vs 60.6%; P < 0.001). Multivariate regression analysis confirmed afTR as independent predictor for TR persistence (adjusted OR: 2.80; 95% CI: 1.66-4.76; P < 0.001). Moreover, afTR was associated with aggravation of TR after TAVR (17.0% vs 6.8%; P = 0.013). Three-year all-cause mortality was significantly higher in patients with persistence compared with patients with improvement of TR (P < 0.001)., Conclusions: In TAVR patients, afTR is an independent predictor for TR persistence. Moreover, TR persistence is associated with increased 3-year all-cause mortality., Competing Interests: Funding Support and Author Disclosures Drs Steffen and Deseive have received speaker honoraria from AstraZeneca. Dr Orban has received speaker honoraria from Abbott Medical, AstraZeneca, Abiomed, Bayer vital, Biotronik, Bristol-Myers Squibb, CytoSorbents, Daiichi Sankyo Deutschland, Edwards Lifesciences Services, and Sedana Medical. Dr Braun has received speaker honoraria from Abbott Vascular and Edwards Lifesciences. Dr Hausleiter has received research support and speaker honoraria from Abbott Vascular and Edwards Lifesciences. 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: Patients undergoing transcatheter aortic valve implantation (TAVI) frequently have coronary artery disease requiring percutaneous coronary intervention (PCI). Usually, PCI and TAVI are performed in two separate procedures and current studies are investigating potential benefits regarding the order. However, the two interventions may also be performed simultaneously, thereby limiting the risk associated with repeated vascular access. Data evaluating benefit and harm of concomitant procedures are scarce., Aims: Therefore, this study aimed to evaluate concomitant PCI (coPCI) in TAVI patients regarding Valve Academic Research Consortium 3 (VARC-3) endpoints and long-term mortality., Methods: A total of 2233 consecutive TAVI patients from the EVERY-VALVE registry were analyzed according to the VARC-3 endpoint definitions. A total of 274 patients had undergone TAVI and concomitant PCI (coPCI group). They were compared to 226 TAVI patients who had received PCI within 60 days before TAVI in a stepwise approach (swPCI group) and to the remaining 1733 TAVI patients who had not undergone PCI recently (noPCI group)., Results: Overall median age was 81.4 years, median Society of Thoracic Surgeons score was 4.0%. Patients in the coPCI and in the swPCI group were predominantly male with reduced left-ventricular ejection fraction. Rates of VARC-3 composite endpoints technical success and 30-day device success were comparable between all three groups. Mortality rates at 3 years after TAVI were similar (coPCI, 34.2% vs. swPCI, 31.9% vs. noPCI, 34.0% p = 0.84)., Conclusions: coPCI during TAVI seems comparable in a retrospective analysis. Compared to a stepwise approach, it has similar rates of composite endpoints technical success and device success as well as long-term mortality., (© 2023 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Background: New-generation self-expanding transcatheter aortic heart valves (THV) were designed to overcome technical constraints of their preceding generations. We sought to compare the efficacy and safety of the self-expanding ACURATE neo2 (Neo2) versus Evolut PRO (PRO) devices., Methods: Seven hundred nine patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) with either Neo2 (n = 496) or PRO (n = 213) were included. Propensity score matching (PSM) was performed to account for differences in baseline characteristics. In-hospital and 30-day clinical outcomes were evaluated according to Valve Academic Research Consortium-3 criteria., Results: Baseline characteristics were comparable between both groups after PSM (Neo2: n = 155, Evolut Pro: n = 155). Technical success rates were high in both groups (Neo2: 94.8% vs PRO: 97.4%; p = 0.239). Need for permanent pacemaker implantation was less frequent with Neo2 compared with PRO (7.5% vs 20.6%; p = 0.002), whereas major vascular complications were more frequent with Neo2 (Neo2: 11.6% vs PRO: 4.5%; p = 0.022). Intended valve performance at discharge was high in both groups without relevant differences among groups (Neo2: 97.4% vs. 95.3%; p = 0.328)., Conclusions: Short-term outcomes after TAVI using latest-generation self-expanding THV were excellent, with overall low rates of adverse events. However, Neo2 was associated with lower pacemaker rates and reduced the prevalence of moderate-severe paravalvular leakage. Transprosthetic gradients after TAVI were higher with Neo2 compared with PRO., (© 2023. The Author(s).)

Background: Permanent pacemaker implantation (PPI) remains a relevant complication after transcatheter aortic valve implantation (TAVI) and its impact on outcome remains controversial., Aims: This study aimed to analyze the effects of implantation depth on PPI at 30 days and assess its impact on outcome with the balloon-expandable Sapien 3 (S3) prosthesis., Methods: Between 2014 and 2018, 849 patients without previous pacemaker undergoing transfemoral TAVI with the S3 were included. Prosthesis implantation depth was measured and divided into Quintiles. An ordinal logistic regression was used to assess its association with PPI, while a multivariate logistic regression was performed to identify predictors of PPI. Survival analyses were performed with the Kaplan-Meier method and a multivariable Cox regression was performed to ascertain the impact of PPI on mortality., Results: Overall, incidence of PPI at 30 days was 9.7%. Implantation depth decreased consistently from a median of 6.7 mm [5.55-8.00] in 2014 to 2.7 mm [2.30-3.50] in 2018 (p < 0.001). When considering Quintiles of implantation depth, incidence of PPI was significantly higher in upper Quintiles and risk for PPI was significantly lower for the 1. Quintile compared to the 5. Quintile (OR: 0.34, 95% CI: [0.16-0.73]; p = 0.003). In the adjusted multivariable logistic regression implantation depth persisted ad independent predictor of PPI at 30 days. Patients requiring PPI at 30 days displayed significantly higher mortality at 4 years compared to patients without PPI (49.5% vs. 40.0%; log-rank = 0.022). In a multivariate analysis, increased logistic EuroScore, diabetes mellitus, and history of atrial fibrillation, were independent predictors of all-cause mortality at 2 years., Conclusions: Higher prosthesis implantation relative to the virtual aortic annulus was significantly associated with reduced risk for PPI at 30 days. Patients with PPI at 30 days exhibited higher mortality during follow-up, however, only logistic EuroScore, diabetes mellitus, and history of atrial fibrillation were identified as independent predictors of mortality at 2 years., (© 2023 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Background: Cardiohepatic syndrome (CHS) has been identified as an important but underrecognized survival predictor in multiple cardiovascular disease entities. The objectives of this study were to evaluate the prevalence and prognostic value of CHS in patients undergoing TAVR for severe aortic stenosis (AS)., Methods: The study included patients with available laboratory parameters of hepatic function who underwent TAVR from July 2013 until December 2019 at our center. CHS was defined as an elevation of at least two of three laboratory cholestasis parameters above the upper limit of normal (bilirubin, alkaline phosphatase, and gamma glutamyl transferase). Study endpoints were three-year survival, technical and device failure (VARC 3), as well as New York Heart Association (NYHA) functional class at follow-up., Results: Among a total of 953 analyzed patients (47.6% females, median age 80.0 [76.0-85.0] years) CHS was present in 212 patients (22.4%). In patients with vs. without CHS, rates of technical (6.1% vs. 8.4%, p = 0.29) and device failure (18.9% vs. 17.3%, p = 0.59) were comparable. NYHA functional class at baseline and follow-up was more severe in patients with CHS. Nevertheless, heart failure symptoms improved from baseline to follow-up irrespective of hepatic function. Three-year survival rates were significantly lower in patients with CHS (49.4 vs. 65.4%, p < 0.001). The predictive value of CHS persisted after adjustment in a multivariable analysis (hazard ratio 1.58, p < 0.01)., Conclusion: In patients undergoing TAVR, CHS is prevalent in 22% of patients and is associated with increased postinterventional mortality. Thus, CHS should be included in the decision-making process within the TAVR heart team. Cardiohepatic syndrome (CHS) as defined by an elevation of at least two of three laboratory cholestasis parameters above the upper limit of normal was prevalent in 22% of patients undergoing TAVR for severe AS. The presence of CHS was associated with more severe heart failure symptoms and worse three-year survival., (© 2023. The Author(s).)

Background: Concomitant moderate/severe mitral regurgitation (MR) is observed in 17-35% of patients undergoing transcatheter aortic valve implantation (TAVI) and contributes to a worse prognosis. Studies analysing outcomes in patients undergoing TAVI with different MR aetiologies, including atrial functional MR (aFMR), are lacking., Aims: We aimed to analyse outcomes and changes in MR severity in patients with aFMR, ventricular functional (vFMR) and primary mitral regurgitation (PMR) following TAVI., Methods: We analysed all consecutive patients with at least moderate MR undergoing TAVI between January 2013 and December 2020 at the Munich University Hospital. Characterisation of MR aetiology was performed by detailed individual echocardiographic assessment. Three-year mortality, changes in MR severity and New York Heart Association (NYHA) Functional Class at follow-up were assessed., Results: Out of 3,474 patients undergoing TAVI, 631 patients showed MR ≥2+ (172 with aFMR, 296 with vFMR, 163 with PMR). Procedural characteristics and endpoints were comparable between groups. The rate of MR improvement was 80.2% in aFMR patients, which was significantly higher compared to both other groups (vFMR: 69.4%; p=0.03; PMR: 40.8%; p<0.001). The estimated 3-year survival rates did not differ between aetiologies (p=0.57). However, MR persistence at follow-up was associated with increased mortality (hazard ratio 1.49, 95% confidence interval: 1.04-2.11; p=0.027), mainly driven by the PMR subgroup of patients. NYHA Class improved significantly in all groups. In patients with baseline MR ≥3+, the PMR aetiology was associated with the lowest MR improvement, the lowest survival rates and least symptomatic improvement., Conclusions: TAVI reduces MR severity and symptoms in patients with aFMR, vFMR and less-pronounced PMR. The presence of aFMR was associated with the greatest MR severity improvement.

Aims: Standardized data definitions are necessary for the quantification of quality of care and patient outcomes in observational studies and randomised controlled trials (RCTs). The European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart) project of the European Society of Cardiology (ESC) aims to create pan-European data standards for cardiovascular diseases and interventions, including transcatheter aortic valve implantation (TAVI)., Methods and Results: We followed the EuroHeart methodology for cardiovascular data standard development. A Working Group of 29 members representing 12 countries was established and included a patient representative, as well as experts in the management of valvular heart disease from the European Association of Percutaneous Cardiovascular Interventions (EAPCI), the European Association of Cardiovascular Imaging (EACVI) and the Working Group on Cardiovascular Surgery. We conducted a systematic review of the literature and used a modified Delphi method to reach consensus on a final set of variables. For each variable, the Working Group provided a definition, permissible values, and categorized the variable as mandatory (Level 1) or additional (Level 2) based on its clinical importance and feasibility. In total, 93 Level 1 and 113 Level 2 variables were selected, with the level 1 variables providing the dataset for registration of patients undergoing TAVI on the EuroHeart IT platform., Conclusion: This document provides details of the EuroHeart data standards for TAVI processes of care and in-hospital outcomes. In the context of EuroHeart, this will facilitate quality improvement, observational research, registry-based RCTs and post-marketing surveillance of devices, and pharmacotherapies., One-Sentence Summary: The EuroHeart data standards for transcatheter aortic valve implantation (TAVI) are a set of internationally agreed data variables and definitions that once implemented will facilitate improvement of quality of care and outcomes for patients receiving TAVI., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Aim: The aim of this study was to analyse the predictive value of CTA-determined tricuspid annular dilatation (TAD) on the persistence of tricuspid regurgitation (TR) in patients undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) and concomitant at least moderate TR., Methods and Results: 288 consecutive patients treated with TAVR due to severe AS and concomitant at least moderate TR at baseline were included in the analysis. As cutoff for TAD, the median value of the CTA-determined, to the body surface area-normalized tricuspid annulus diameter (25.2 mm/m 2 ) was used. TAD had no impact on procedural characteristics or outcomes, including procedural death and technical or device failure according to the Valve Academic Research Consortium 3 criteria. However, the primary outcome of the study-TR persistence after TAVR was significantly more frequent in patients with compared to patients without TAD (odds ratio 2.60, 95% confidence interval 1.33-5.16, p < 0.01). Multivariable logistic regression analysis, adjusting for clinical and echocardiographic baseline characteristics, which are known to influence aetiology or severity of TR, confirmed TAD as an independent predictor of TR persistence after TAVR (adjusted odds ratio 2.30, 95% confidence interval 1.20-4.46, p = 0.01). Moreover, 2 year all-cause mortality was significantly higher in patients with persistence or without change of TR compared to patients with TR improvement (log-rank p < 0.01)., Conclusion: In patients undergoing TAVR for severe AS and concomitant at least moderate TR at baseline, TAD is a predictor of TR persistence, which is associated with increased 2-year all-cause mortality., (© 2023. The Author(s).)

Early menopause is associated with an increased risk of cardiovascular diseases, including aortic stenosis (AS). We sought to investigate the prevalence and impact of early menopause on clinical outcomes in patients who underwent transcatheter aortic valve implantation (TAVI) for severe symptomatic AS. Women's International TAVI is a multinational, prospective, observational registry of women who underwent TAVI for severe symptomatic AS (n = 1,019). Patients were divided into 2 groups based on age of menopause: early menopause (age ≤45 years) and regular menopause (age >45 years). The primary outcome of interest was Valve Academic Research Consortium 2 efficacy end point, a composite of mortality, stroke, myocardial infarction, hospitalization for valve-related symptoms, or heart failure or valve-related dysfunction at 1-year follow-up. Of 732 patients with available data on menopause age, 173 (23.6%) were classified as having early menopause. These patients presented for TAVI at a younger age (81.6 ± 6.9 vs 82.7 ± 5.9, p = 0.05) and had a significantly lower Society of Thoracic Surgeons score (6.6 ± 4.8 vs 8.2 ± 7.1, p = 0.03) than those with regular menopause. However, the total valve calcium volume was smaller among patients with early versus regular menopause (731.8 ± 850.9 mm 3 vs 807.6 ± 633.8 mm 3 , p = 0.002). Other co-morbidities were similar between the 2 groups. At 1-year follow-up, there were no significant differences in clinical outcomes between patients with early versus regular menopause (hazard ratio 1.00, 95% confidence interval 0.61 to 1.63, p = 1.00). In conclusion, despite presenting for TAVI at a younger age, patients with early menopause had a similar risk of adverse events as patients with regular menopause at 1 year after TAVI., Competing Interests: Disclosures Dr. Chieffo received consultancy fees from Abiomed, Biosensor, Edwards and Shockwave Medical and payments for lecturs from Boston Scientific and Abbot Vascular. Dr. Dangas received a research grant to institution form Daiichi-Sankyo. Dr. Lefèvre received consultancy fees from Edwards, Boston Scientific and Abbot. Dr. Mehran received research grants to the institution from Abbott, Abiomed, Alleviant Medical, AM-Pharma, Amgen, Applied Therapeutics, Arena, AstraZeneca, BAIM, Bayer, Beth Israel Deaconess, Biosensors, Biotronik, Boston Scientific, Bristol-Myers Squibb, CardiaWave, CellAegis, CeloNova, CERC, Chiesi, Concept Medical, CSL Behring, Cytosorbents, DSI, Duke University, Element Science, Faraday, Humacyte, Idorsia, Insel Gruppe AG, Magenta, Medtronic, Novartis, OrbusNeich, PhaseBio, Philips, RenalPro, Shockwave, Vivasure, Zoll, consulting fees from Cine-Med Research, WebMD. Dr. Morice is CEO and shareholder of CERC, a CRO not involved in this trial. Dr. Petronio received consultancy fees from Medtronic, Abbott, Boston Scientific, and funds from Boston Scientific and Abbott. Dr. Spirito received a research grant from the Swiss National Science Foundation. Dr. Van Mieghem received research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, Abiomed, PulseCath BV, Daiichi Sankyo, Pie Medical. Dr Watanabe is a clinical proctor of TAVR for Edwards Lifesciences and Medtronic. The other authors have no relevant disclosures., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: No detailed data on left bundle branch block (LBBB) and permanent pacemaker implantation (PPI) exist from randomised clinical trials comparing the ACURATE neo and CoreValve Evolut devices., Aims: Our aim was to assess the incidence and impact of new LBBB and PPI with self-expanding prostheses from a powered randomised comparison., Methods: From the SCOPE 2 trial, 648 patients with no previous pacemaker were analysed for PPI at 30 days, and 426 patients without previous LBBB were adopted for analysis of LBBB at 30 days.  Results: At 30 days, 16.5% of patients required PPI; rates were higher in CoreValve Evolut compared to ACURATE neo recipients (21.0% vs 12.3%; p=0.004). Previous right bundle branch block (odds ratio [OR] 6.11, 95% confidence interval [CI]: 3.19-11.73; p<0.001) was associated with an increased risk of PPI at 30 days, whereas the use of the ACURATE neo (OR 0.50, 95% CI: 0.31-0.81; p=0.005) was associated with a decreased risk. One-year mortality was similar in patients with and without new PPI. A total of 9.4% of patients developed persistent LBBB at 30 days, with higher incidences in CoreValve Evolut recipients (13.4% vs 5.5%; p=0.007). New LBBB at 30 days was associated with lower ejection fraction at 1 year (65.7%±11.0 vs 69.1%±7.6; p=0.041)., Conclusions: New LBBB and PPI rates were lower in ACURATE neo compared to CoreValve Evolut recipients. The ACURATE neo valve was associated with a lower risk of PPI at 30 days. No effect on 1-year mortality was determined for PPI at 30 days, while LBBB at 30 days was associated with reduced ejection fraction at 1 year.

Objectives: To investigate the feasibility and safety of percutaneous transluminal angioplasty (PTA) of the iliofemoral arteries (IFA) before transfemoral transcatheter aortic valve implantation (Tf-TAVI) in patients with advanced peripheral artery disease (PAD)., Background: Although Tf-TAVI represents the access of choice, alternative vascular access routes are preferred for patients displaying advanced PAD. PTA of the IFA represents a less invasive option, broadening the spectrum of patients eligible for Tf-TAVI., Methods: All patients requiring PTA of the IFA before Tf-TAVI, between 2012 and 2021, were included. Primary efficacy endpoint was the rate of successful transcatheter heart valve (THV) delivery and implantation. Primary safety endpoint was the rate of PTA and access-site-related vascular complications, procedural- and in-hospital complications., Results: Among 2726 Tf-TAVI procedures, 59 patients required IFA predilation. Successful THV delivery and implantation was achieved in 57 (96.6%) patients, respectively. Sheath placement was achieved in 59 (100%) patients with only one minor dissection and no major vascular complications following iliofemoral PTA. Regarding access site complications, two (3.4%) vessel perforations and one (1.7%) vessel rupture were observed, with eight (13.5%) patients requiring unplanned endovascular interventions. There was one intraprocedural death due to THV-induced vessel laceration, while in-hospital all-cause mortality was 8.5% in the present high-risk patient cohort., Conclusions: Predilation of IFA is safe and effective in patients with advanced PAD. Careful preprocedural planning is paramount in improving procedural safety and efficacy. This strategy has the potential to broaden the spectrum of patients eligible for Tf-TAVI., (© 2023 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Our study investigated the feasibility to measure pressure profiles inside the inflation balloon during direct implantation of Edwards Sapien 3 ultra-prostheses using an additional syringe with a digital pressure read-out. Pressure profiles of 15 patients for 26 mm valve size were analyzed. Uniform patterns were found for 5 patients similar to those of previously acquired in vitro curves. 10 patients showed strikingly different pressure profiles compared to the above-mentioned group, marked by an earlier pressure increase, single or multiple pressure drops or higher overall pressure. Measuring the percentage of under-expansion of the prostheses, using calibrated angiographic projections revealed a significant difference between both groups. Our data raises the hypothesis that the acquisition of pressure profiles might help to better understand not only the implantation procedure itself but also the highly individual patient-device interaction, offering new information and a new perspective on optimization of TAVR implantation in the future., (© 2022. The Author(s).)

Background: Transcatheter aortic valve implantation (TAVI) has become an accepted treatment for patients with severe aortic stenosis (AS). Predicting which patients are at risk for adverse clinical outcomes after TAVI remains difficult, especially in women., Aim: To identify predictors of adverse events in the WIN-TAVI cohort., Methods: The WIN-TAVI study is an observational registry of 1019 women undergoing TAVI for severe symptomatic AS. Follow-up was 1 year. The primary outcome was defined according to VARC-2: a composite of mortality, stroke, myocardial infarction or hospitalization for valve-related symptoms or heart failure. The secondary outcome was a composite of cardiovascular mortality or hospitalization for valve-related symptoms or heart failure., Results: We included 1019 women with severe AS (mean age of 82.5 ± 6.3 years). At 1 year, 16.4% of the patients experienced the primary endpoint and 12.6% the secondary endpoint. The use of oral anticoagulants (OAC) was the strongest independent predictor of the primary outcome (adjusted hazard ratio [aHR] 1.51, 95% confidence interval [CI] 1.079-2.106, p = 0.016). Independent predictors of the secondary endpoint were age (aHR 1.04 per year, 95% CI 1.01-1.074, p = 0.016) and use of OAC (aHR: 1.79, 95% CI 1.24-2.60, p = 0.002). OAC use was not associated with higher bleeding risk., Conclusion: Pre-procedural use of OAC was the strongest predictor of adverse outcomes during 1-year follow-up, likely reflecting a combination of high-risk factors and comorbidities, but was not related to increased bleeding risk., Competing Interests: Declaration of Competing Interest Dr. Petronio received consultancy fees from Medtronic, Abbott, Boston Scientific, and funds from Boston Scientific and Abbott. Dr. Lefèvre received consultancy fees from Edwards, Boston Scientific and Abbot. Dr. Van Mieghem received research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, Abiomed, PulseCath BV, Daiichi Sankyo, Pie Medical. Dr. Morice is CEO and shareholder of CERC, a CRO not involved in this trial. Dr. Dangas received a research grant to institution form Daiichi-Sankyo. Dr. Chieffo received consultancy fees from Abiomed, Biosensor, Edwards and Shockwave Medical and payments for lecturs from Boston Scientific and Abbot Vascular. Dr. Mehran received research grants to the institution from Abbott, Abiomed, Alleviant Medical, AM-Pharma, Amgen, Applied Therapeutics, Arena, AstraZeneca, BAIM, Bayer, Beth Israel Deaconess, Biosensors, Biotronik, Boston Scientific, Bristol-Myers Squibb, CardiaWave, CellAegis, CeloNova, CERC, Chiesi, Concept Medical, CSL Behring, Cytosorbents, DSI, Duke University, Element Science, Faraday, Humacyte, Idorsia, Insel Gruppe AG, Magenta, Medtronic, Novartis, OrbusNeich, PhaseBio, Philips, RenalPro, Shockwave, Vivasure, Zoll, consulting fees from Cine-Med Research, WebMD., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Background: No comparative data exist with the latest generation self-expanding ACURATE neo2 (Neo2) and the balloon-expandable SAPIEN 3 Ultra (Ultra) transcatheter heart valves (THV)., Aims: We aimed to compare the outcomes after transcatheter aortic valve implantation (TAVI) using the Neo2 and the Ultra THV., Methods: A total of 1,356 patients at 4 centres were treated either with the Neo2 (n=608) or the Ultra (n=748). The primary endpoint was device success according to the latest Valve Academic Research Consortium definitions. The association of the THV used and the primary endpoint was assessed using inverse probability treatment weighting (IPTW) and 1:1 propensity score matching (PSM), which identified 472 matched pairs.  Results: After PSM, there were no relevant differences between the groups. While rates of moderate to severe paravalvular leakage (PVL) were overall low (0.6% vs 1.1%; p=0.725), elevated transvalvular gradients (≥20 mmHg) were less frequent with the Neo2 (2.4% vs 7.7%; p<0.001), which translated into a significantly higher rate of device success with the Neo2 compared with the Ultra (91.9% vs 85.0%; p<0.001). Consistently, the Neo2 was associated with higher rates of device success in the IPTW analysis (odds ratio [OR] 1.961, 95% confidence interval [CI]: 1.269-3.031; p=0.002). Rates of mild PVL were significantly lower with the Ultra compared with the Neo2 (20.0% vs 32.8%; p<0.001). Clinical events at 30 days were comparable between the 2 groups., Conclusions: Short-term outcomes after TAVI using the Neo2 or Ultra THV were excellent and, overall, comparable. However, transvalvular gradients were lower with the Neo2, which translated into higher rates of device success. Rates of mild PVL were significantly lower with the Ultra THV.

Given the recent surge in transcatheter heart valve replacement (THVR), cardiac surgeons will surely face the challenge of eventual explantation. The aim of this study was to determine indications for reoperation, while exploring pertinent technical aspects and survival after THV explantation in a cohort originally deemed high risk or even inoperable. Between February 2008 and March 2019, 31 patients with failed transcatheter aortic valve replacement (TAVR) underwent surgical explantations at our facility. Data were prospectively collected for retrospective analysis of procedural indications, technical issues, and postoperative survival. The major reason for TAVR removal was bioprosthetic valve failure (BVF) due to infective endocarditis (IE: 16/31 [51.6%]), non-structural (NSVD: 14/31 [45.2%]) and structural (SVD: 1/31 [3.2%]) valve deterioration accounting for the rest. Mean age at THV explantation was 76.3 ± 8.3 years, and median time from TAVR to explantation was 153 days (0 days-56.6 months). Median ICU and hospital stay were 6 days (1-44 days) and 23 days (8-62 days), respectively. Thirty-day and 1-year survival rates were 74.2% and 67.2%, respectively. Median follow-up interval after explantation was 364 days (3 days-80 months). Mean cardiopulmonary bypass time was 124.6 ± 46.8 min, and mean aortic cross-clamp time was 84.3 ± 32.9 min. There was no need for unplanned aortic root repair owing to tissue damage during dissection of the TAVR from surrounding tissue. The most common reason for THV explantation was (a) BVF for IE and (b) BVF secondary to NSVD. Although 30-day and 1-year mortality rates in this multimorbid cohort were predictably high, no procedural mortalities occurred., (© 2022. The Author(s).)

Background: Large-bore arteriotomy for transcatheter aortic valve implantation (TAVI) requires percutaneous vascular closure devices, but real-world data comparing different closure strategies are limited., Aims: We sought to compare a dual ProGlide strategy vs a combination of one ProGlide and one FemoSeal for vascular closure after TAVI., Methods: We retrospectively analysed 874 propensity score-matched patients undergoing TAVI at the Munich University Hospital from August 2018 to October 2020. From August 2018 to August 2019, a dual ProGlide strategy was used for vascular closure. From October 2019 to October 2020, a combination of one ProGlide and one FemoSeal was used. The primary endpoint was defined as access-related major vascular complications or bleeding ≥Type 2 according to Valve Academic Research Consortium 3 criteria., Results: Patients in the dual ProGlide group (n=437) had a higher incidence of the primary endpoint than patients treated with one ProGlide and one FemoSeal (n=437; 11.4% vs 3.0%; p<0.001). Furthermore, they had a higher rate of closure device failure (2.7% vs 0.9%; p=0.044) and more often required unplanned surgery or endovascular treatment (3.9% vs 0.9%; p=0.004). The incidence of death did not differ significantly between groups (3.4% vs 1.6%; p=0.08)., Conclusions: A combined ProGlide and FemoSeal strategy might have the potential to reduce access-related vascular complications following TAVI.

Background: Transcatheter aortic-valve replacement (TAVR) for the treatment of aortic stenosis can lead to embolization of debris. Capture of debris by devices that provide cerebral embolic protection (CEP) may reduce the risk of stroke., Methods: We randomly assigned patients with aortic stenosis in a 1:1 ratio to undergo transfemoral TAVR with CEP (CEP group) or without CEP (control group). The primary end point was stroke within 72 hours after TAVR or before discharge (whichever came first) in the intention-to-treat population. Disabling stroke, death, transient ischemic attack, delirium, major or minor vascular complications at the CEP access site, and acute kidney injury were also assessed. A neurology professional examined all the patients at baseline and after TAVR., Results: A total of 3000 patients across North America, Europe, and Australia underwent randomization; 1501 were assigned to the CEP group and 1499 to the control group. A CEP device was successfully deployed in 1406 of the 1489 patients (94.4%) in whom an attempt was made. The incidence of stroke within 72 hours after TAVR or before discharge did not differ significantly between the CEP group and the control group (2.3% vs. 2.9%; difference, -0.6 percentage points; 95% confidence interval, -1.7 to 0.5; P = 0.30). Disabling stroke occurred in 0.5% of the patients in the CEP group and in 1.3% of those in the control group. There were no substantial differences between the CEP group and the control group in the percentage of patients who died (0.5% vs. 0.3%); had a stroke, a transient ischemic attack, or delirium (3.1% vs. 3.7%); or had acute kidney injury (0.5% vs. 0.5%). One patient (0.1%) had a vascular complication at the CEP access site., Conclusions: Among patients with aortic stenosis undergoing transfemoral TAVR, the use of CEP did not have a significant effect on the incidence of periprocedural stroke, but on the basis of the 95% confidence interval around this outcome, the results may not rule out a benefit of CEP during TAVR. (Funded by Boston Scientific; PROTECTED TAVR ClinicalTrials.gov number, NCT04149535.)., (Copyright © 2022 Massachusetts Medical Society.)

Introduction: Aortic valve neocuspidization (AVNeo) for trileaflet aortic valve reconstruction using autologous pericardium (Ozaki procedure) depicts an encouraging new technique for the surgical treatment of aortic valve pathologies. The current study analyzes the early hemodynamic outcome of AVneo compared with surgical aortic valve replacement (SAVR) using the Abbott/St. Jude Trifecta aortic valve biological prostheses., Methods: All patients who underwent either AVNeo or SAVR between March 2017 and April 2020 were included. Exclusion criteria were emergency cases, endocarditis, redo- or additional root procedures. Main endpoints were differences between the two groups in terms of the effective orifice area (EOA) and the effective orifice area index (EOAI) at discharge., Results: During the study period, 105 AVNeo patients and 458 SAVR patients met the inclusion criteria. EOA was significantly higher in the AVNeo group (2.4 cm 2  ± 0.8 vs. 2.1 cm 2 /m 2  ± 0.6 in the SAVR group, respectively; p < .001). Multiple regression analysis, including AVNeo, annulus size, bicuspid valve, preoperative stenosis, left ventricular ejection fraction (LVEF), and diastolic diameter (LVEDD) found two factors, which favor larger EOA: Annulus size (p < .0001) and AVneo (p = .005). EOAI was significantly higher in the AVNeo group (1.23 ± 0.4 vs. 1.02 cm 2 /m 2  ± 0.3, respectively; p < .001). Multiple regression analysis for EOAI showed effects for AVneo (p = .005) and bicuspid valve (p = .029). Mean pressure gradients (MPG) were lower in the AVNeo group than in the SAVR group (AVNeo: MPG = 8.0 mmHg ± 3.6 vs. SAVR: MPG = 8.3 mmHg ± 3.6), but this finding did not reach statistical significance (p = .091)., Conclusions: AVNeo shows significantly larger EOA and EOAI compared to SAVR using the Abbott/St. Jude Trifecta aortic valve biological prostheses., (© 2022 The Authors. Journal of Cardiac Surgery published by Wiley Periodicals LLC.)

Objective: A novel artificial intelligence-based phenotyping approach to stratify patients with severe aortic stenosis (AS) prior to transcatheter aortic valve replacement (TAVR) has been proposed, based on echocardiographic and haemodynamic data. This study aimed to analyse the recovery of extra-aortic valve cardiac damage in accordance with this novel stratification system following TAVR., Methods: The proposed phenotyping approach was previously established employing data from 366 patients with severe AS from a bicentric registry. For this consecutive study, echocardiographic follow-up data, obtained on day 147±75.1 after TAVR, were available from 247 patients (67.5%)., Results: Correction of severe AS by TAVR significantly reduced the proportion of patients suffering from concurrent severe mitral regurgitation (from 9.29% to 3.64%, p value: 0.0015). Moreover, pulmonary artery pressures were ameliorated (estimated systolic pulmonary artery pressure: from 47.2±15.8 to 43.3±15.1 mm Hg, p value: 0.0079). However, right heart dysfunction as well as the proportion of patients with severe tricuspid regurgitation remained unchanged. Clusters with persistent right heart dysfunction ultimately displayed 2-year survival rates of 69.2% (95% CI 56.6% to 84.7%) and 74.6% (95% CI 65.9% to 84.4%), which were significantly lower compared with clusters with little or no persistent cardiopulmonary impairment (88.3% (95% CI 83.3% to 93.5%) and 85.5% (95% CI 77.1% to 94.8%))., Conclusions: This phenotyping approach preprocedurally identifies patients with severe AS, who will not recover from extra-aortic valve cardiac damage following TAVR and whose survival is therefore significantly reduced. Importantly, not the degree of pulmonary hypertension at initial presentation, but the irreversibility of right heart dysfunction determines prognosis., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background and Purpose: Development and progression of heart failure involve endothelial and myocardial dysfunction as well as a dysregulation of the NO-sGC-cGMP signalling pathway. Recently, we reported that the sGC stimulator riociguat has beneficial effects on cardiac remodelling and progression of heart failure in response to chronic pressure overload. Here, we examined if these beneficial effects of riociguat were also reflected in alterations of the myocardial proteome and microRNA profiles., Experimental Approach: Male C57BL/6N mice underwent transverse aortic constriction (TAC) and sham-operated mice served as controls. TAC and sham animals were randomised and treated with either riociguat or vehicle for 5 weeks, starting 3 weeks after surgery, when cardiac hypertrophy was established. Afterwards, we performed mass spectrometric proteome analyses and microRNA sequencing of proteins and RNAs, respectively, isolated from left ventricles (LVs)., Key Results: TAC-induced changes of the LV proteome were significantly reduced by treatment with riociguat. Bioinformatics analyses revealed that riociguat improved TAC-induced cardiovascular disease-related pathways, metabolism and energy production, for example, reversed alterations in the levels of myosin heavy chain 7, cardiac phospholamban and ankyrin repeat domain-containing protein 1. Riociguat also attenuated TAC-induced changes of microRNA levels in the LV., Conclusion and Implications: The sGC stimulator riociguat exerted beneficial effects on cardiac structure and function during pressure overload, which was accompanied by a reversal of TAC-induced changes of the cardiac proteome and microRNA profile. Our data support the potential of riociguat as a novel therapeutic agent for heart failure., (© 2022 The Authors. British Journal of Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.)

Objectives: With the expansion of transcatheter aortic valve replacement (TAVR) into intermediate and low risk, the number of TAVR procedures is bound to rise and along with it the number of cases of infective endocarditis following TAVR (TIE). The aim of this study was to review a multicentre experience of patients undergoing surgical intervention for TIE and to analyse the underlying indications and operative results., Methods: We retrospectively identified and analysed 69 patients who underwent cardiac surgery due to TIE at 9 cardiac surgical departments across Germany. The primary outcome was operative mortality, 6-month and 1-year survival., Results: Median age was 78 years (72-81) and 48(69.6%) were male. The median time to surgical aortic valve replacement was 14 months (5-24) after TAVR, with 32 patients (46.4%) being diagnosed with early TIE. Cardiac reoperations were performed in 17% of patients and 33% underwent concomitant mitral valve surgery. The main causative organisms were: Enterococcus faecalis (31.9%), coagulase-negative Staphylococcus spp. (26.1%), Methicillin-sensitive Staphylococcus aureus (15.9%) and viridians group streptococci (14.5%). Extracorporeal life support was required in 2 patients (2.9%) for a median duration of 3 days. Postoperative adverse cerebrovascular events were observed in 13 patients (18.9%). Postoperatively, 9 patients (13.0%) required a pacemaker and 33 patients (47.8%) needed temporary renal replacement therapy. Survival to discharge was 88.4% and survival at 6 months and 1 year was found to be 68% and 53%, respectively., Conclusions: Our results suggest that TIE can be treated according to the guidelines for prosthetic valve endocarditis, namely with early surgery. Surgery for TIE is associated with acceptable morbidity and mortality rates. Surgery should be discussed liberally as a treatment option in patients with TIE by the 'endocarditis team' in referral centres., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. 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.)

Objectives: The aim of this study was to evaluate the surgical outcome of patients suffering from native aortic valve (NVE) or prosthetic aortic valve endocarditis (PVE) treated with the EDWARDS INTUITY Elite rapid-deployment valve prosthesis., Methods: Between February 2019 and June 2020, 25 patients suffering from NVE (n = 9; 36%) and PVE (n = 16; 64%) of the aortic valve received an INTUITY valve at our institution. Preoperative, operative and follow-up data were collected., Results: In our cohort, the mean EuroSCORE II was 13.4%. Eleven patients (44%) received concomitant aortic root patch plasty. Four patients (16%) received coronary artery bypass graft surgery, 3 patients (12%) received mitral valve repair and 2 patients (8%) underwent replacement of the ascending aorta. The cardiopulmonary bypass and aortic cross-clamp times were 124 ± 56 and 75 ± 39 min, respectively. The mean intensive care unit stay was 5 days. The mean size of the implanted prostheses was 25 ± 2 mm and the mean prosthesis transvalvular gradient 3 months after surgery was 9 ± 4 mmHg. During follow-up, no case of recurrent endocarditis occurred, 1 patient died of multisystem organ failure which had already been present preoperatively., Conclusions: Surgery for NVE and PVE of the aortic valve may be safely performed using the EDWARDS INTUITY Elite valve system. This procedure could be well implemented in cases with extensive infection, fragile root tissue and root abscesses requiring root reconstruction. In our institution, the rapid-deployment aortic valve replacement strategy has become an important tool in the armamentarium of the surgical endocarditis treatment., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: We aimed to describe stroke and transient ischemic attacks (TIAs) after transcatheter aortic valve replacement (TAVR) and to identify associated risk factors., Background: Stroke/TIA after TAVR is a major complication., Methods: A total of 1919 concomitant patients underwent TAVR in a single center from 2007 to 2017. Pre-, intra-, and postprocedural data were collected prospectively in a database and analyzed retrospectively. Stroke and TIA were documented according to the Valve Academic Research Consortium-II criteria. Logistic regression was used to determine risk factors for stroke after TAVR., Results: Mean age was 79.5 ± 6.8 years, mean logistic EuroScore was 17.6% ± 12.8%, and 51.8% (n = 994) of the patients were female. Stroke/TIA occurred in 76 patients (3.9%), 1.9% were disabling, and 1.6% nondisabling. The predominant type of stroke were territorial ischemic lesions (82.4%), with primary bleeding in 4.4% and border zone infarctions in 4.4%. Left-sided lesions were more common (45.6% left sided vs. 25% right sided) and 13.2% of the lesions were bilateral (4.4% no finding and 11.8% missing data). In multivariate logistic regression, prior stroke (odds ratio [OR] = 1.83, p = 0.046) and initial experience (first 300 TAVR implanted at our center) were identified as independent risk factors for stroke/TIA during the first 30 days (OR = 1.95, p = 0.045). Overall, the occurrence of stroke had a highly significant impact on a 30-day mortality (13.2% vs. 4.9% in patients without stroke (p = 0.005)., Conclusion: Stroke within the first 30 days after TAVR severely impairs 30-day survival. We identified prior stroke and initial experience as significant independent risk factors for the occurrence of stroke after TAVR., (© 2022 Wiley Periodicals LLC.)

Background: Third-generation transcatheter heart valves (THV) are predominantly implanted through a percutaneous, transfemoral access. To reduce vascular complications, we selectively performed surgical vascular access (cutdown) in patients with particular calcified or small femoral arteries. We aim to review our experience with this approach., Methods: All patients who underwent transfemoral transcatheter aortic valve replacement (TAVR) with a third-generation THV at our institution between March 2014 and April 2019 were included in the study. All available computerized tomography studies were reassessed for access vessel diameter and visual graduation of calcifications. Vascular complications are reported according to Valve Academic Research Consortium-2 criteria., Results: A total of 944 patients were included. Among them, 879 patients underwent a percutaneous access and 65 patients underwent surgical cutdown. Also, 459 Evolut R/PRO and 420 Sapien 3/ultra were implanted percutaneously and 40 Evolut R/PRO and 25 Sapien 3 were implanted with a surgical cutdown. Patients with surgical cutdown were older (80.0 ± 7.5 vs. 83.8 ± 7.5 years, p  < 0.001), had smaller femoral arteries (8.0 ± 1.6 vs. 7.6 ± 1.6 mm, p  = 0.034) and more severe vessel calcifications (17.5 vs. 1.0%, p  < 0.001). Procedure time was similar for cutdown and percutaneous access (64.0 vs. 64.5 minutes, p  = 0.879). With percutaneous access, 80 major vascular complications (10%) occurred, whereas with surgical cutdown, no major vascular complications occurred ( p  < 0.005). No wound infection occurred after surgical cutdown. The mean length of stay was 8 days in both groups., Conclusion: Surgical cutdown for vascular access avoids vascular complications in patients with small or severely calcified femoral arteries., Competing Interests: None of the authors has a conflict of interest to declare., (Thieme. All rights reserved.)

Background: The dual-filter Sentinel™ Cerebral Protection System (Sentinel-CPS) is increasingly used during transcatheter aortic valve replacement (TAVR). However, complex vascular anatomy may challenge Sentinel-CPS deployment., Aim of the Study: We sought to investigate the impact of anatomic features of the aortic arch and the supra-aortic arteries on technical device failure of Sentinel-CPS application., Methods: Analysis of the multislice computed tomography pre-TAVR aortograms of all patients undergoing TAVR with Sentinel-CPS between 2016 and 2020 (n = 92) was performed. We investigated the impact of aortic arch anatomy, configuration, and the angles of the supra-aortic arteries, including the determination of vascular tortuosity index on device failure of Sentinel-CPS application., Results: The Sentinel-CPS was applied successfully in 83 patients (90.2%). Device failure in nine patients (9.8%) was due to the infeasibility to perform correct deployment of both filters (n = 7) and to obtain peripheral radial access (n = 2). Patients with a failure of Sentinel-CPS application had a higher right subclavian tortuosity index (217 [92-324] vs. 150 [42-252], p = .046), a higher brachiocephalic tortuosity index (27 [5-51] vs. 10 [0-102], p = 0.033) and a larger angulation of the brachiocephalic artery (59° [22-80] vs. 39° [7-104], p = .014) compared with patients with successful application. A brachiocephalic angle more than 59° was predictive for device failure. No differences in aortic arch anatomy or common carotid artery tortuosity were detected between the groups., Conclusions: Brachiocephalic tortuosity was found to be associated with failure of Sentinel-CPS application. Filter-based usage should be avoided in TAVR patients with a brachiocephalic angle more than 59°., (© 2021 The Authors. Journal of Cardiac Surgery Published by Wiley Periodicals LLC.)

Background: Bicuspid aortic valve may be associated with increased complications during transcatheter aortic valve implantation (TAVI)., Aims: Compare balloon-expandable transcatheter heart valve (THV) safety and efficacy in severe tricuspid (TAV) and bicuspid (BAV) aortic stenosis., Methods: Transfemoral TAVI was performed in 743 patients (Jan 2014-June 2019) using the SAPIEN 3 THV. Aortic valve morphology was determined using computed tomography. Valve Academic Research Consortium-2 (VARC-2) derived safety and efficacy endpoints at 1 year were evaluated., Results: BAV patients (n = 78), were younger (77 [72, 81] vs. 81 [78, 85] years, p < 0.001) with lower surgical risk (EuroSCORE II 2.96% vs. 4.51% p < 0.001). Bicuspid valves were more calcified (BAV 1308mm 3 , TAV 848mm 3 p < 0.001) with more asymmetric calcification (BAV 63/78 (81%), TAV 239/665 (36%), p < 0.001). Device success (BAV 94%, TAV 90%, p = 0.45) and major vascular complications (BAV 6%, TAV 9%, p = 0.66) were comparable. At 1 year, there was a trend toward lower combined all-cause mortality and rehospitalization for congestive heart failure in BAV patients (BAV 7%, TAV 13%, p = 0.08) with significantly lower all-cause mortality in this cohort (BAV 1%, TAV 9%, p = 0.020). VARC-2 time-related valve safety (BAV 22%, TAV 20%, p = 0.60) was comparable; however, bioprosthetic valve thrombosis remained more common in BAV patients (BAV 7%, TAV 2%, p = 0.010, Hazard ratio 3.57 [95% confidence interval 1.26, 10.10]). After propensity score matching, only bioprosthetic valve thrombosis remained significantly different., Conclusions: Safety and efficacy of the SAPIEN 3 balloon-expandable THV in BAV is comparable with TAV. Higher rates of bioprosthetic valve thrombosis require further investigation., (© 2021. Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Baseline right ventricular (RV) dysfunction represents a predictor for poor outcome in patients undergoing transcatheter aortic valve replacement (TAVR). However, RV function may improve after TAVR, which could have important implications on outcomes. The aim of the present study was to assess changes in RV function after TAVR and its prognostic value regarding clinical outcome., Methods and Results: Patients undergoing TAVR at our institution were consecutively enrolled and categorized into 4 groups according to changes in RV function during echocardiographic follow-up at 6 months. A total of 188 patients were included. Of those showing normal function at baseline, 87% (130/149) had preserved RV function at follow-up (group 1), whereas 13% (19/149) developed new RV dysfunction (group 2). Of those with RV dysfunction at baseline (39 patients), RV function normalized in 46% (18/39) (group 3) and remained impaired in 54% (21/39) (group 4). The Kaplan-Meier estimated survival at 3 years was highest in patients in group 1 (83%), intermediate in group 2 (65%) and 3 (69%), whereas group 4 had the worst survival (37%; P < .001). Furthermore, new or persistent RV dysfunction was identified to be independently associated with mortality during follow-up (hazard ratio 2.55; interquartile range 1.03-6.47, P = .004)., Conclusions: Patients with preserved RV function have a high 3-year survival. Normalization of RV function showed improved survival compared with patients with persistent RV dysfunction, who had a dismal prognosis despite TAVR., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve implantation (TAVI) has become standard treatment for elderly patients with symptomatic severe aortic valve stenosis. The ACURATE neo AS study evaluates 30-day and 1-year clinical and hemodynamic outcomes in patients treated with the ACURATE neo2 valve., Methods: The primary endpoint of this single-arm multicenter study is 30-day all-cause mortality. Other key endpoints include device performance, echocardiographic measures assessed by an independent core laboratory, and VARC-2 clinical efficacy and safety endpoints through 12 months., Results: The study enrolled 120 patients (mean age 82.1 ± 4.0 years; 67.5% female, mean baseline STS score 4.8 ± 3.8%). The VARC-2 composite safety endpoint at 30 days occurred in 13.3% of patients. All-cause mortality was 3.3% at 30 days and 11.9% at 1 year. The 30-day stroke rate was 2.5% (disabling stroke 1.7%); there were no new strokes between 30 days and 12 months. The rate of permanent pacemaker implantation was 15.0% (18/120) at 30 days and 17.8% (21/120) at 1 year. No patients required re-intervention for valve-related dysfunction and there were no cases of valve thrombosis or endocarditis. Patients demonstrated significant improvement in mean aortic valve gradient (baseline 38.9 ± 13.1 mmHg, 1 year 7.8 ± 3.5 mmHg; P < 0.001 in a paired analysis). In the overall population, paravalvular leak was evaluated at 1 year as none/trace in 60.5%, mild in 37.0%, and moderate in 2.5%; no patients had severe PVL., Conclusions: One-year outcomes from the ACURATE neo AS study support the safety and performance of TAVI with the ACURATE neo2 valve., (© 2021. The Author(s).)

Objectives: To describe the incidence, predictors, and clinical impact of permanent pacemaker insertion (PPI) following transcatheter aortic valve replacement (TAVR) in women., Background: Data on pacemaker insertion complicating TAVR in women are scarce., Methods: The Women's International Transcatheter Aortic Valve implantation (WIN-TAVI) is a prospective registry evaluating the safety and efficacy of TAVR in women. We included patients without preprocedural pacemakers and divided them into two groups: (1) PPI and (2) no-PPI. We identified PPI predictors using logistic regression and studied its clinical impact on the Valve Academic Research Consortium (VARC)-2 efficacy and safety endpoints., Results: Out of 1019 patients, 922 were included in the analysis. Post-TAVR PPI occurred in 132 (14.3%) patients. Clinical and procedural characteristics were similar in both groups. Pre-existing right bundle branch block (RBBB) was associated with a high risk of post-TAVR PPI (OR 3.62, 95% CI 1.85-7.06, p < 0.001), while implantation of balloon-expandable prosthesis was associated with a lower risk (OR 0.47, 95% CI 0.30-0.74, p < 0.001). Post-TAVR PPI prolonged in-hospital stay by a median of 2 days (11 [9-16] days in PPI vs. 9 [7-14] days in no-PPI, p = 0.005), yet risks of VARC-2 efficacy and safety endpoints at 1 year were similar in both groups ( adj HR 0.95, 95% CI 0.60-1.52, p = 0.84 and adj HR 1.22, 95% CI 0.83-1.79, p = 0.31, respectively)., Conclusion: Pacemaker implantation following TAVR is frequent among women and is associated with pre-existing RBBB and valve type. PPI prolongs hospital stay, albeit without any significant impact on 1-year outcomes., (© 2021 Wiley Periodicals LLC.)

Objectives: The aim of this retrospective analysis was to categorize patients with severe aortic stenosis (AS) according to clinical presentation by applying unsupervised machine learning., Background: Patients with severe AS present with heterogeneous clinical phenotypes, depending on disease progression and comorbidities., Methods: Unsupervised agglomerative clustering was applied to preprocedural data from echocardiography and right heart catheterization from 366 consecutively enrolled patients undergoing transcatheter aortic valve replacement for severe AS., Results: Cluster analysis revealed 4 distinct phenotypes. Patients in cluster 1 (n = 164 [44.8%]), serving as a reference, presented with regular cardiac function and without pulmonary hypertension (PH). Accordingly, estimated 2-year survival was 90.6% (95% CI: 85.8%-95.6%). Clusters 2 (n = 66 [18.0%]) and 4 (n = 91 [24.9%]) both comprised patients with postcapillary PH. Yet patients in cluster 2 with preserved left and right ventricular structure and function showed a similar survival as those in cluster 1 (2-year survival 85.8%; 95% CI: 76.9%-95.6%), whereas patients in cluster 4 with dilatation of all heart chambers and a high prevalence of mitral and tricuspid regurgitation (12.5% and 14.8%, respectively) died more often (2-year survival 74.9% [95% CI: 65.9%-85.2%]; HR for 2-year mortality: 2.8 [95% CI: 1.4-5.5]). Patients in cluster 3, the smallest (n = 45 [12.3%]), displayed the most extensive disease characteristics (ie, left and right heart dysfunction together with combined pre- and postcapillary PH), and 2-year survival was accordingly reduced (77.3% [95% CI: 65.2%-91.6%]; HR for 2-year mortality: 2.6 [95% CI: 1.1-6.2])., Conclusions: Unsupervised machine learning aids in capturing complex clinical presentations as observed in patients with severe AS. Importantly, structural alterations in left and right heart morphology, possibly due to genetic predisposition, constitute an equally sensitive indicator of poor prognosis compared with high-grade PH., Competing Interests: Funding Support and Author Disclosures Dr Lachmann has received funding from the Technical University of Munich (clinician scientist grant) and from the Else Kröner-Fresenius Foundation (clinician scientist grant). The 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.)

As we approach 20 years of clinical experience with transcatheter aortic valve replacement (TAVR), a vast portfolio of high-quality clinical data has accumulated, confirming the safety and efficacy of TAVR across the entire spectrum of surgical risk. Although many aspects of this innovative therapy have been thoroughly studied, several challenges remain. As TAVR is expanding to include younger low-risk patients, with longer life expectancy, one major unsolved issue is represented by transcatheter heart valve (THV) durability, since robust THV durability data are currently limited to approximately 5-6 years. Additionally, steric interactions between THV components and coronary ostia may render coronary access particularly difficult, and thus personalized decisions regarding THV type and implanting techniques are of paramount importance to secure future coronary access. Since bicuspid aortic valve (BAV) stenosis may be associated with unfavorable anatomic factors, it has represented an exclusion criterion in major randomized TAVR trials. Albeit promising data are available from multicenter registries, results of specifically designed randomized trials are eagerly needed to inform use of TAVR for BAV stenosis. Although valve-in-valve (ViV) TAVR has emerged as an effective treatment option for degenerated aortic bioprostheses, ViV procedures are associated with specific risks, which mandated the development of specific techniques aimed at reducing the occurrence of periprocedural adverse events. Despite the transfemoral approach represents the access of choice for TAVR, a significant proportion of patients have significant peripheral artery disease and alternative vascular access routes have been increasingly evaluated with encouraging data regarding their safety and feasibility., (© 2021. Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

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.

Transcatheter aortic valve implantation (TAVI) is effective in older patients with symptomatic severe aortic stenosis, while the indication has recently broadened to younger patients at lower risk. Although thromboembolic and bleeding complications after TAVI have decreased over time, such adverse events are still common. The recommendations of the latest 2017 ESC/EACTS Guidelines for the management of valvular heart disease on antithrombotic therapy in patients undergoing TAVI are mostly based on expert opinion. Based on recent studies and randomized controlled trials, this viewpoint document provides updated therapeutic insights in antithrombotic treatment during and after TAVI., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)

Objectives: To assess the impact of anemia on clinical outcomes in female patients enrolled in the Women's InterNational transcatheter aortic valve implantation (WIN-TAVI) registry., Background: Anemia is highly prevalent among females who constitute half of TAVI candidates, yet, its clinical significance remains poorly investigated., Methods: Patients were divided into three groups according to preprocedural hemoglobin (Hb) level: (1) no anemia (Hb ≥12 g/dl), (2) mild-to-moderate anemia (10 ≤ Hb <12 g/dl), and (3) severe anemia (Hb <10 g/dl). The primary outcome was the occurrence of Valve Academic Research Consortium (VARC)-2 efficacy endpoint, a composite of mortality, stroke, myocardial infarction (MI), hospitalization for valve-related symptoms or heart failure or valve-related dysfunction at 1-year follow-up., Results: Hemoglobin level was available in 877 (86.1%) patients: 412 (47.0%) had no anemia, 363 (41.4%) had mild-to-moderate anemia, and 102 (11.6%) had severe anemia. The latter group had a higher prevalence of cardiovascular risk factors. Compared with patients without anemia, severe anemia was associated with a greater risk of VARC-2 efficacy endpoint ( adj HR 1.71, 95% CI: 1.02-2.87, p = .04), all-cause death ( adj HR 2.36, 95% CI: 1.31-4.26, p = .004) and a composite of death, MI or stroke ( adj HR 1.88, 95% CI: 1.10-3.22, p = .02) at 1 year. Moreover, an increased risk of late mortality ( adj HR 1.15, 95% CI: 1.02-1.30, p = .03) was observed with every 1 g/dl decrease in hemoglobin level., Conclusion: Severe anemia in females undergoing TAVI was independently associated with increased rates of VARC-2 efficacy endpoint and mortality at 1 year., (© 2020 Wiley Periodicals LLC.)

Background: There is growing body of evidence from retrospective studies that renin-angiotensin system (RAS) blockade is associated with improved outcome after transcatheter aortic valve replacement (TAVR). However, it remains unknown whether the effect of RAS blockade is dose dependent. The current study sought to assess the dose-dependent effect of RAS blockade on survival and left-ventricular (LV) remodelling after TAVR., Methods: Patients who were enrolled into our observational TAVR study at our institution were retrospectively assessed according to different doses of RAS blockade: group 1 (no RAS blockade), group 2 (25% of maximum daily dose), group 3 (50% of maximum daily dose), and group 4 (full daily dose)., Results: A total of 323 patients between January 2015 and September 2019 were included. Patients with higher doses of RAS blockade showed a trend toward higher overall survival at 3-year follow-up (56% with no RAS blockade vs 66% with the 25% dose vs 79% with the 50% dose vs 78% with the full dose; P = 0.063). After adjustment for baseline characteristics, the difference in survival was significant (P = 0.042). Besides New York Heart Association class and left-ventricular ejection fraction (LVEF), RAS blockade dose was identified as independent predictor for all-cause mortality (hazard ratio [HR] 0.72; 95% confidence interval [CI], 0.54-0.97; P = 0.03). With respect to LV remodelling, a significantly larger reduction of LV mass index was observed during the follow-up with higher doses of RAS blockade., Conclusions: The current study showed that the impact of RAS blockade treatment on clinical outcome and LV remodelling after TAVR is dose dependent., (Copyright © 2020 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)