Background: In October 2022, the Heart Valve Collaboratory and Food and Drug Administration convened a global multidisciplinary workshop to address the unmet clinical need to promote and accelerate the development of pediatric-specific heart valve technologies.
Methods: The Pediatric Heart Valve Global Multidisciplinary Workshop was convened in October 2022. Key stakeholders, including expert clinicians in pediatric cardiology and cardiac surgery, valve manufacturers, engineers and scientists were assembled to review the current state-of-the-art, discuss unique challenges in the pre-and post-market evaluation of pediatric valve therapies, and highlight emerging technologies that show potential to address some of the key unmet needs of children with valve disease.
Purpose: Incorporating patient-reported outcomes (PROs) into survivorship care may improve the comprehensiveness of follow-up. The objective was to engage stakeholders to develop a PRO assessment of survivors' symptoms and concerns for use during breast cancer follow-up.
Methods: We convened patient and oncologist stakeholder advisory groups to develop an initial PRO assessment including survivorship domains of importance, measurement instruments, and clinically significant thresholds, and revise the assessment based on feedback from community focus groups and two rounds of iterative pilot testing with survivors.
The modern congenital heart surgeon has an array of materials available for cardiovascular repair. With advancements in the surgical outcomes for pediatric cardiac defects, choice of material has become increasingly dependent on late-term complications associated with each material. Calcification is a leading long-term complication and is increasing in prevalence with materials lasting longer in patients.
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