Summary: Transcatheter aortic valve implantation using the selfexpandable CoreValve prosthesis was performed in 663 patients with severe aortic stenosis and high surgical risk in 14 Italian centers. Procedural success was 98% and intraprocedural mortality was 0.9%. The mortality rates at 30 days and 1 year were 5.4% and 15.0%, respectively. Early mortality was acceptably low compared with the anticipated risk calculated by means of the EuroSCORE and was strongly associated with the occurrence of procedural complications. Late mortality continued to occur from 30 days to 1 year after TAVI, primarily as the effect of postprocedural paravalvular aortic regurgitation Ն2ϩ and nonvalve related comorbidities such as cerebrovascular disease, chronic kidney disease and heart failure. Clinical and hemodynamic benefits observed acutely after TAVI were sustained at 1 year. It was the first randomized study to demonstrate both the critical role of the left atrial appendage in the pathogenesis of AF-related stroke and the ability of a filter device to recapitulate the clinical benefit of warfarin. However, the procedural safety of this new invasive procedure was a source of concern. Based on PROTECT AF and the Continued Access Protocol Registry, a registry that has followed the trial, we assessed the safety of left atrial appendage closure, including the temporal distribution of safety events, the rate of events with increased experience, and the functional significance of these events. This analysis revealed that the safety events in the Watchman group are largely clustered early in the periprocedural period and, after this point, the risk is minimal; that these safety events decrease in frequency with greater operator experience, particularly the rate of periprocedural stroke and pericardial effusion/tamponade; and that the rates of events resulting in significant disability or death were statistically significantly lower for the Watchman device compared with warfarin therapy in PRO-TECT AF. This article suggests that despite a higher numeric rate of complications with Watchman implantation compared with warfarin, a more nuanced understanding of these data indicates that the safety of left atrial appendage closure is more favorable when one considers the differential functional impact of these events and the significant decrease in the frequency of events with operator experience.
Conclusion:As with all interventional procedures, there is a significant improvement in the safety of Watchman left atrial appendage closure with increased operator experience. 4
Efficacy of Quantified Home-Based Exercise and Supervised Exercise in Patients With Intermittent Claudication: A Randomized Controlled TrialSummary: A primary therapeutic goal for patients with peripheral artery disease and intermittent claudication is to regain lost ambulatory function through exercise rehabilitation. Medically supervised exercise programs are efficacious for improving claudication onset time and peak walking time, but more patients could benefit from an...