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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.)

Objectives: To determine whether outcomes from transcatheter aortic valve implantation (TAVI) vary according to access route and valve type in a real-world population., Background: Registry and uncontrolled trial data have found that patients undergoing nonfemoral TAVI have higher early and late mortality. It is not clear whether worse outcomes relate directly to access route. There have been no direct comparisons of outcomes according to valve type., Methods: Data were collected prospectively on 1,620 patients undergoing TAVI in the UK and compared in 4 groups: SAPIEN transfemoral (TF); SAPIEN transapical (TA); CoreValve TF, CoreValve subclavian. Univariable and multivariable regression analysis was performed to identify independent predictors of mortality., Results: Mortality in patients undergoing SAPIEN TAVI via a TA approach was higher than with TF at 30 days (11.2% vs. 4.4%, P < 0.01), 1 year (28.7% vs. 18.1%, P = 0.01), and 2 years (56.0% vs. 43.5%, P = 0.01). Logistic EuroSCORE was higher in TA patients (22.5 ± 12.9% vs. 17.7 ± 11.1%, P < 0.0001). After multivariable analysis TA access was associated with increased mortality at 30 days (OR 2.56, 95% CI 1.46-4.48, P < 0.01) and 2 years (OR 1.75, 1.08-2.74, P = 0.02). There was no significant difference in mortality at any time-point between patients treated with SAPIEN (n = 812) and CoreValve (n = 808) prostheses. CoreValve-treated patients had a higher rate of permanent pacemaker implantation (23.1% vs. 7.2%, P < 0.0001), and grade ≥2 aortic regurgitation on postprocedure echocardiography (13.0% vs. 7.3%, P < 0.01)., Conclusions: Patients undergoing TA TAVI experienced increased early and late mortality compared to a TF approach. Survival was not influenced by valve type., (© 2013, Wiley Periodicals, Inc.)

Gender differences exist in outcomes after percutaneous coronary intervention and coronary artery bypass graft surgery but have yet to be fully explored after transcatheter aortic valve implantation. We aimed to investigate gender differences after transcatheter aortic valve implantation in the UK National Institute for Cardiovascular Outcomes Research registry. A retrospective analysis was performed of Medtronic CoreValve and Edwards SAPIEN implantation in 1,627 patients (756 women) from January 2007 to December 2010. Men had more risk factors: poor left ventricular systolic function (11.9% vs 5.5%, p <0.001), 3-vessel disease (19.4% vs 9.2%, p <0.001), previous myocardial infarction (29.5% vs 13.0%, p <0.001), peripheral vascular disease (32.4% vs 23.3%, p <0.001), and higher logistic EuroSCORE (21.8 ± 14.2% vs 21.0 ± 13.4%, p = 0.046). Thirty-day mortality was 6.3% (confidence interval 4.3% to 7.9%) in women and 7.4% (5.6% to 9.2%) in men and at 1 year, 21.9% (18.7% to 25.1%) and 22.4% (19.4% to 25.4%), respectively. There was no mortality difference: p = 0.331 by log-rank test; hazard ratio for women 0.91 (0.75 to 1.10). Procedural success (96.6% in women vs 96.4% in men, p = 0.889) and 30-day cerebrovascular event rates (3.8% vs 3.7%, p = 0.962) did not differ. Women had more major vascular complications (7.5% vs 4.2%, p = 0.004) and less moderate or severe postprocedural aortic regurgitation (7.5% vs 12.5%, p = 0.001). In conclusion, despite a higher risk profile in men, there was no gender-related mortality difference; however, women had more major vascular complications and less postprocedural moderate or severe aortic regurgitation., (Copyright © 2014 Elsevier Inc. All rights reserved.)

This registry was set up to create a comprehensive record of all TAVI procedures performed in the United Kingdom since the introduction of the technique in 2007, to help drive quality improvement and provide data for research. Funding is independent of industry. All hospitals in the UK provide data for every consecutive patient where TAVI was attempted. The dataset includes variables defining patient demographic features, indications, procedural details and outcomes up to the time of hospital discharge. There are variables for follow up at 1 and 3 years assessing symptoms and life status. An updated dataset will be collected from 2013. Mortality is tracked centrally. Data entry is performed by clinical staff and data clerks. No external validation. The data are available for research by application to the UK TAVI Steering Group using a data sharing agreement which can be obtained at NICOR (www.ucl.ac.uk/nicor/).

Background: Routine pre-discharge echocardiography (ECHO) is recommended post transcatheter aortic valve implantation (TAVI) as a baseline for future comparison. However, there is no clear guidance on the optimal timing of this study. Aim: The purpose of this retrospective study was to investigate the safety and work-force efficiency of intraprocedural same-day ECHO versus next-day ECHO, following transfemoral TAVI. Methods and results: In this retrospective study 100 consecutive patients who underwent intraprocedural ECHO only were compared with 100 consecutive patients undergoing both intraprocedural and routine next-day ECHO following elective transfemoral TAVI. All patients received the Sapien 3/Ultra transcatheter heart valve and were treated with a minimalist procedure with conscious sedation. The composite of in-hospital mortality, urgent ECHO and new tamponade after leaving the cath lab and before discharge was not different between the two groups (4 vs. 4%, P = 1). There was no paravalvular leak more than mild in any of the cases. Length of stay was similar (1 day). Conclusions: Intraprocedural post-TAVI ECHO appears as safe as next day pre-discharge ECHO and obviates the need for a routine next day study, thereby reducing burden on echocardiography services and allows better utilisation of resources. [ABSTRACT FROM AUTHOR]

Background Aortic valve disease is the most prevalent valvular abnormality in the developed world and carries a high risk of morbidity and mortality. Transcatheter aortic valve replacement (TAVR) is favoured over open-heart surgery in high-risk patient categories and is increasingly used in lower-risk groups. End stage kidney disease (ESKD) is associated with premature calcific degeneration of bioprosthetic heart valves. Redo-TAVR requires meticulous pre-procedural planning to avoid the important risks of sinus sequestration and impaired coronary access. Transcatheter aortic valve replacement with the Acurate Neo transcatheter heart valve (THV) has been clinically available for a short time only and there are limited reports describing redo-TAVR in the Acurate Neo. Case summary We present a case of early, rapid onset, structural valve degeneration in a Acurate Neo, supra-annular, self-expanding THV in a dialysis patient. The patient presented with chest pain and breathlessness 4 years after TAVR with a Acurate Neo for severe stenosis of a bicuspid aortic valve. Echocardiogram now showed severe stenosis of the THV and computed tomography revealed severe THV leaflet calcification but no pannus or leaflet thrombus. After careful pre-procedural planning a S3 Ultra balloon-expandable valve was selected and positioned relatively high to pin the first THV leaflets in a fully open position without compromising coronary artery flow or coronary access. Discussion End stage kidney disease may cause rapid, calcific degeneration of TAVR valves leading to presentation with severe aortic stenosis. Redo-TAVR in the Acurate Neo THV with a Sapien 3 Ultra is feasible with careful pre-procedural planning to mitigate the risks of sinus sequestration and impaired coronary access. [ABSTRACT FROM AUTHOR]

Small studies have suggested left ventricular (LV) rapid pacing has similar safety and efficacy to conventional right ventricular (RV) rapid pacing in transcatheter aortic valve implantation (TAVI). However, there are limited data on the comparative rates of tamponade. The study compared the rate of cardiac tamponade between LV and RV-pacing during TAVI. Between 2008 and 2021, 1226 consecutive patients undergoing transfemoral or transaxillary TAVI were included. 470(38.3%) patients had TAVI deployment with RV-pacing and 756(61.7%) with LV-pacing. The primary outcome was the frequency and cause of cardiac tamponade. Secondary outcomes included efficacy, procedure duration and crossover rates. There was a trend to less tamponade with LV-pacing, which did not reach statistical significance [11(2.3%) vs 11(1.5%); P = 0.27]. There was no significant difference in the frequency of tamponade due to annular tear [4(0.9%) vs 9(1.2%); P = 0.59] or LV free-wall perforation [1(0.2%) vs 2(0.3%); P = 0.86]. The frequency of tamponade due to RV perforation was significantly lower in the LV-pacing group [0 vs 6(2.3%); P < 0.005)]. Two patients with tamponade due to RV perforation required emergency sternotomy of whom one died. Deployment success was similar (99% vs 99.6%; P =NS). Procedure duration was shorter with LV-pacing (70 vs 80 mins; P < 0.005). Crossover to RV-pacing was low (0.9%). There were no embolizations caused by loss-of-capture in either group. LV-pacing appears equally efficacious and is associated with a lower risk of tamponade due to RV perforation caused by the temporary pacing wire. LV-pacing was not associated with an increased risk of tamponade due to LV free-wall perforation. • LV pacing for TAVI deployment is safe, time-efficient, cost-effective and reduces the risk tamponade due to RV pacing. • LV pacing may facilitate streamlined TAVI procedures in the cath lab. [ABSTRACT FROM AUTHOR]