The Registry Assessment of Peripheral Devices (RAPID) convened a multidisciplinary group of stakeholders including clinicians, academicians, regulators and industry representatives to conduct an in-depth review of limitations associated with the data available to assess the paclitaxel mortality signal. Available studies were evaluated to identify strengths and limitations in the study design and data quality, which were translated to lessons learned to help guide the design, execution, and analyses of future studies. We suggest numerous actionable responses, such as the development and use of harmonized data points and outcomes in a consensus lean case report form.
View Article and Find Full Text PDFBackground: Aortic valve replacement in the young adult (aged 18 to 50 years) is a choice between a mechanical prosthesis with attendant lifelong anticoagulation or biological prostheses of varying types that may have limited life expectancy in this age group.
Methods: The Cardiac Surgical Research Foundation database was accessed to determine long-term outcomes in patients having aortic valve replacement with the St. Jude Medical Valve.
Background And Aim Of The Study: The choice of a cardiac valve for patients with aortic valvular pathology remains controversial. Younger patients may be at risk for long-term complications from chronic anticoagulation yet require prosthesis longevity, while older patients may not outlive a bioprosthesis. To gather information to help decision-making, the 20-year experience of aortic valve replacement (AVR) with the St.
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