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Objectives: The aim of this study was to assess the added value and predictive power of the TAVIguide (Added Value of Patient-Specific Computer Simulation in Transcatheter Aortic Valve Implantation) software in clinical practice., Background: Optimal outcome after transcatheter aortic valve replacement (TAVR) may become more important as TAVR shifts toward low-risk patients. Patient-specific computer simulation is able to provide prediction of outcome after TAVR. Its clinical role and validation of accuracy, however, have not yet been studied prospectively., Methods: A prospective, observational, multicenter study was conducted among 80 patients with severe aortic stenosis treated with the Evolut R valve. Simulation was performed in 42 patients and no simulation in 38. A comparison between the valve size (decision 1) and target depth of implantation selected by the operator on the basis of multislice computed tomography and the valve size (decision 2) and target depth of implantation selected after simulation were the primary endpoints. Predictive power was examined by comparing the simulated and observed degree of aortic regurgitation., Results: Decision 2 differed from decision 1 in 1 of 42 patients because of predicted paravalvular leakage, and changes in valve type occurred in 2 of 42. In 39 of 42 patients, decisions 1 and 2 were similar. Target depth of implantation differed in 7 of 42 patients after simulation (lower in 4 and higher in 3). In 16 of 42 patients, simulation affected the TAVR procedure; in 9, the operator avoided additional measures to achieve the target depth of implantation, and in 7 patients, additional measures were performed. There was a trend toward a higher degree of predicted than observed aortic regurgitation (17.5 vs. 12 ml/s; p = 0.13)., Conclusions: Patient-specific computer simulation did not affect valve size selection but did affect the selection of the target depth of implantation and the execution of TAVR to achieve the desired target depth of implantation., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Reducing sitting time as well as increasing physical activity in inactive people is beneficial for their health. This paper investigates the effectiveness of the European Fans in Training (EuroFIT) programme to improve physical activity and sedentary time in male football fans, delivered through the professional football setting., Methods and Findings: A total of 1,113 men aged 30-65 with self-reported body mass index (BMI) ≥27 kg/m2 took part in a randomised controlled trial in 15 professional football clubs in England, the Netherlands, Norway, and Portugal. Recruitment was between September 19, 2015, and February 2, 2016. Participants consented to study procedures and provided usable activity monitor baseline data. They were randomised, stratified by club, to either the EuroFIT intervention or a 12-month waiting list comparison group. Follow-up measurement was post-programme and 12 months after baseline. EuroFIT is a 12-week, group-based programme delivered by coaches in football club stadia in 12 weekly 90-minute sessions. Weekly sessions aimed to improve physical activity, sedentary time, and diet and maintain changes long term. A pocket-worn device (SitFIT) allowed self-monitoring of sedentary time and daily steps, and a game-based app (MatchFIT) encouraged between-session social support. Primary outcome (objectively measured sedentary time and physical activity) measurements were obtained for 83% and 85% of intervention and comparison participants. Intention-to-treat analyses showed a baseline-adjusted mean difference in sedentary time at 12 months of -1.6 minutes/day (97.5% confidence interval [CI], -14.3-11.0; p = 0.77) and in step counts of 678 steps/day (97.5% CI, 309-1.048; p < 0.001) in favor of the intervention. There were significant improvements in diet, weight, well-being, self-esteem, vitality, and biomarkers of cardiometabolic health in favor of the intervention group, but not in quality of life. There was a 0.95 probability of EuroFIT being cost-effective compared with the comparison group if society is willing to pay £1.50 per extra step/day, a maximum probability of 0.61 if society is willing to pay £1,800 per minute less sedentary time/day, and 0.13 probability if society is willing to pay £30,000 per quality-adjusted life-year (QALY). It was not possible to blind participants to group allocation. Men attracted to the programme already had quite high levels of physical activity at baseline (8,372 steps/day), which may have limited room for improvement. Although participants came from across the socioeconomic spectrum, a majority were well educated and in paid work. There was an increase in recent injuries and in upper and lower joint pain scores post-programme. In addition, although the five-level EuroQoL questionnaire (EQ-5D-5L) is now the preferred measure for cost-effectiveness analyses across Europe, baseline scores were high (0.93), suggesting a ceiling effect for QALYs., Conclusion: Participation in EuroFIT led to improvements in physical activity, diet, body weight, and biomarkers of cardiometabolic health, but not in sedentary time at 12 months. Within-trial analysis suggests it is not cost-effective in the short term for QALYs due to a ceiling effect in quality of life. Nevertheless, decision-makers may consider the incremental cost for increase in steps worth the investment., Trial Registration: International Standard Randomised Controlled Trials, ISRCTN-81935608., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: AM is a paid statistical advisor for PLOS Medicine. AM’s institution received funding from the European Union FP7 funding programme, covering salaries of staff within the Robertson Centre for Biostatistics who provided statistical and data management support to the study. DJM and DWL work for PAL Technologies Ltd., a manufacturer of the activPAL and SitFIT, and a partner in EuroFIT.

Objectives: The aim of the CoreValve prospective, international, post-market ADVANCE-II study was to define the rates of conduction disturbances and permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement with the Medtronic CoreValve System (Minneapolis, Minnesota) using optimized implantation techniques and application of international guidelines on cardiac pacing., Background: Conduction disturbances are a frequent complication of transcatheter aortic valve replacement. The rates of PPI in the published reports vary according to bioprosthesis type and the indications for PPI., Methods: The primary endpoint was the 30-day incidence of PPI with Class I/II indications when the Medtronic CoreValve System was implanted at an optimal depth (≤6 mm below the aortic annulus). The timing and resolution of all new-onset conduction disturbances were analyzed., Results: A total of 194 patients were treated. The overall rate of PPI for Class I/II indications was 18.2%. An optimal depth was reached in 43.2% of patients, with a nonsignificantly lower incidence of PPI in patients with depths ≤6 mm, compared with those with deeper implants (13.3% vs. 21.1%; p = 0.14). In a paired analysis, new-onset left bundle branch block and first-degree atrioventricular block occurred in 45.4% and 39.0% of patients, respectively, and resolved spontaneously within 30 days in 43.2% and 73.9%, respectively. In patients with new PPI, the rate of intrinsic sinus rhythm increased from 25.9% at 7 days to 59.3% at 30 days (p = 0.004)., Conclusions: Optimal Medtronic CoreValve System deployment and adherence to international guidelines on cardiac pacing are associated with a lower rate of new PPI after transcatheter aortic valve replacement, compared with results reported in previous studies. (CoreValve Advance-II Study: Prospective International Post-Market Study [ADVANCE II]; NCT01624870)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)