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Introduction and Objectives: No comparisons have been published yet regarding the newest iteration of balloon- and self-expandable transcatheter heart valves for the treatment of bicuspid aortic valve (BAV) stenosis., Methods: Multicenter registry of consecutive patients with severe BAV stenosis treated with balloon-expandable transcatheter heart valves (Myval and SAPIEN 3 Ultra, S3U) or self-expanding Evolut PRO+(EP+). TriMatch analysis was carried out to minimize the impact of baseline differences. The primary endpoint of the study was 30-day device success, and the secondary endpoints were the composite and individual components of early safety at 30 days., Results: A total of 360 patients (age 76.6±7.6 years, 71.9% males) were included: 122 Myval (33.9%), 129 S3U (35.8%), and 109 EP+(30.3%). The mean STS score was 3.6±1.9%. There were no cases of coronary artery occlusion, annulus rupture, aortic dissection, or procedural death. The primary endpoint of device success at 30 days was significantly higher in the Myval group (Myval: 100%; S3U: 87.5%; and EP+: 81.3%), mainly due to higher residual aortic gradients with S3U and greater≥moderate aortic regurgitation (AR) with EP+. No significant differences were found in the unadjusted rate of pacemaker implantation., Conclusions: In patients with BAV stenosis deemed unsuitable for surgery, Myval, S3U and EP+showed similar safety but balloon-expandable Myval had better gradients than S3U, and both balloon-expandable devices had lower residual AR than EP+, suggesting that, taking into consideration the patient-specific risks, any of these devices can be selected with optimal outcomes., (Copyright © 2023. Published by Elsevier España, S.L.U.)

Introduction and Objectives: Transcatheter edge-to-edge repair (TEER) should be considered in patients with heart failure and secondary mitral regurgitation (MR). Angiotensin receptor-neprilysin inhibitors (ARNIs) have been demonstrated to improve prognosis in heart failure. We aimed to evaluate the impact ARNIs on patient selection and outcomes., Methods: The population of the Spanish TEER prospective registry (March 2012 to January 2021) was divided into 2 groups: a) TEER before the ARNI era (n=450) and b) TEER after the recommendation of ARNIs by European Guidelines (n=639), with further analysis according to intake (n=52) or not (n=587) of ARNIs., Results: A total of 1089 consecutive patients underwent TEER for secondary MR. In the ARNI era, there was a reduction in left ventricle dilation (82mL vs 100mL, P=.025), and better function (35% vs 38%, P=.011). At 2 years of follow-up, mortality (10.6% vs 17.3%, P <.001) and heart failure readmissions (16.6% vs 27.8%, P <.001) were lower in the ARNI era, but not recurrent MR. In the ARNI era, 1- and 2-year mortality were similar irrespective of ARNI intake but patients on ARNIs had a lower risk of readmission+mortality at 2 years (OR, 0.369; 95%CI, 0.137-0.992; P=.048), better NYHA class, and lower recurrence of MR III-IV (1.9% vs 14.3%, P=.011)., Conclusions: Better patient selection for TEER has been achieved in the last few years with a parallel improvement in outcomes. The use of ARNIs was associated with a significant reduction in overall events, better NYHA class, and lower MR recurrence., (Copyright © 2022 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Introduction and Objectives: Final position of the neo-commissures is uncontrolled during transcatheter aortic valve implantation (TAVI), potentially hindering coronary access and future procedures. We aimed to develop a standard method to achieve commissural alignment with the ACURATE neo valve., Methods: The relationship between native and TAVI neo-commissures was analyzed in 11 severe aortic stenosis patients undergoing TAVI. Based on computed tomography analysis, an in silico model was developed to predict final TAVI commissural posts position. A modified implantation technique, accurate commissural alignment (ACA) and a dedicated delivery system were developed. TAVI implants were tested in 3-dimensional (3D) printed models and in vivo. Commissural misalignment and coronary overlap (CO) were analyzed., Results: The in silico model accurately predicted final position of commissural posts irrespective of the implantation technique performed (correlation coefficient, 0.994; 95%CI, 0.989-0.998; P<.001). TAVI implant with patient-specific rotation was simulated in 3D printed models and in 9 patients. ACA-oriented TAVI implants presented adequate commissural alignment in vivo (mean commissural misalignment of 7.7 ±3.9°). None of the ACA oriented implants showed CO, whereas in silico conventional implants predicted CO in 6 of the 9 cases., Conclusions: Accurate commissural alignment of the ACURATE neo device is feasible by inserting the delivery system with a patient-specific rotation based on computed tomography analysis. This is a simple and reproducible method for commissural alignment that can be potentially used for all kinds of TAVI devices., (Copyright © 2021 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Introduction and Objectives: Aortic self-expandable (SE) transcatheter aortic valve implantation (TAVI) devices are particularly useful for patients with aortic stenosis and small/tortuous vessels, small aortic annuli, or low coronary ostia. However, it is unclear whether the growing range of SE devices shows comparable hemodynamic and clinical outcomes. We aimed to determine the differential hemodynamic (residual valve area and regurgitation) and clinical outcomes of these devices in comparable scenarios., Methods: All patients were enrolled from 4 institutions and were managed with 4 different SE TAVI devices. Baseline and follow-up clinical data were collected and echocardiographic tests blindly and centrally analyzed. Patients were compared according to valve type and a 1:1 matched comparison was performed according to degree of calcification, aortic annulus dimensions, left ventricular ejection fraction, and body surface area., Results: In total, 514 patients were included (Evolut R/PRO, 217; ACURATE neo, 107; ALLEGRA, 102; Portico, 88). Surgical risk scores were comparable in the unmatched population. No differences were observed in the post-TAVI regurgitation rate and in in-hospital mortality (2.7%). The rate of pacemaker implantation at discharge was significantly different among devices (P=.049), with Portico showing the highest rate (23%) and ACURATE neo the lowest (9.5%); Evolut R/PRO and ALLEGRA had rates of 15.9% and 21.2%, respectively. The adjusted comparison showed worse residual TAVI gradients and aortic valve area with ACURATE neo vs ALLEGRA (P=.001) but the latter had higher risk of valve embolization and a tendency for more cerebrovascular events., Conclusions: A matched comparison of 4 SE TAVI devices showed no differences regarding residual aortic regurgitation and in-hospital mortality., (Copyright © 2020 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Introduction and Objectives: To determine whether renin-angiotensin system inhibitor (RASi) prescription is associated with better outcomes after transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR)., Methods: All comparative studies of RASi vs no RASi prescription in patients undergoing TAVI/SAVR were gathered from PubMed, Web of Science, and Google Scholar through August, 2019. We extracted hazard ratios (HRs) with their confidence intervals (CIs) for mortality from each study and combined study-specific estimates using inverse variance-weighted averages of logarithmic HRs in the random effects model., Results: We identified 6 eligible studies with a total of 21 390 patients (TAVI: 17 846; SAVR: 3544) and included them in the present meta-analysis. The 6 studies were observational comparative studies (including 3 propensity score matched and 3 cohort studies) of RASi vs no RASi prescription. The analysis demonstrated that RASi prescription was associated with significantly lower mortality in the whole group of patients undergoing aortic valve intervention (HR, 0.64; 95%CI, 0.47-0.88; P <.001). However, subgroup analysis suggested differences according to the selected therapy, with TAVI showing better mortality rates in the RASi group (HR, 0.67; 95%CI, 0.49-0.93) but not in the SAVR group (HR, 0.61; 95%CI, 0.29-1.30). No funnel plot asymmetry was identified, suggesting minimum publication bias. Sensitivity analyses sequentially eliminating dissimilar studies did not substantially alter the primary result favoring RASI prescription., Conclusions: These findings suggest a mortality benefit of RASi in patients with AS treated with aortic valve replacement that might be particularly relevant following TAVI. Future randomized studies are warranted to confirm this relevant finding., (Copyright © 2020 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Introduction and Objectives: Many patients undergoing transcatheter aortic valve implantation (TAVI) have concomitant mitral regurgitation (MR) of moderate grade or less. The impact of coexistent tricuspid regurgitation (TR) remains to be determined. We sought to analyze the impact of moderate vs none-to-mild MR and its trend after TAVI, as well as the impact of concomitant TR and its interaction with MR., Methods: Multicenter retrospective study of 813 TAVI patients treated through the transfemoral approach with MR ≤ 2 between 2007 and 2015., Results: The mean age was 81 ± 7 years and the mean Society of Thoracic Surgeons score was 6.9% ± 5.1%. Moderate MR was present in 37.3% of the patients, with similar in-hospital outcomes and 6-month follow-up mortality to those with MR < 2 (11.9% vs 9.4%; P = .257). However, they experienced more rehospitalizations and worse New York Heart Association class (P = .008 and .001, respectively). Few patients (3.8%) showed an increase in the MR grade to > 2 post-TAVI. The presence of concomitant moderate/severe TR was associated with in-hospital and follow-up mortality rates of 13% and 34.1%, respectively, regardless of MR grade. Moderate-severe TR was independently associated with mortality (HR, 18.4; 95%CI, 10.2-33.3; P < .001)., Conclusions: The presence of moderate MR seemed not to impact short- and mid-term mortality post-TAVI, but was associated with more rehospitalizations. The presence of moderate or severe TR was associated with higher mortality. This suggests that a thorough evaluation of the mechanisms underlying concomitant mitral and tricuspid valve regurgitation should be performed to determine the best strategy for avoiding TAVI-related futility., (Copyright © 2018 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)