Key result
The document describes the structure, processes, and protocols for conducting cardiovascular outcomes research using the NCDR registries but does not present clinical trial results or effect sizes.
Internationally coordinated medical device registries governed by academic specialty societies are urgently needed to enhance post-market surveillance, regulatory compliance, and real-world evidence generation.
This commentary draws on findings from Hoogervorst et al1 to underscore the urgent need for internationally coordinated medical device registries, addressing the fragmentation and inconsistency currently limiting their utility in Europe. It advocates for registries governed by academic specialty societies to ensure scientific integrity, transparency, and clinical relevance. Such registries can significantly enhance post-market surveillance, support regulatory compliance and accelerate real-world evidence (RWE) generation. The importance of standardized data collection, regular outcome reporting, and contributor recognition to foster engagement and improve data quality is highlighted. By complementing randomized controlled trials (RCTs), registries can detect rare adverse events, inform clinical guidelines and drive innovation. Actionable recommendations for governance, data harmonization and interoperability are given, emphasizing that now is the time for academic societies to lead this transformation for the benefit of patients and healthcare systems globally.
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Herbert Mauch (2026) studied Patients with various cardiovascular conditions enrolled in multiple cardiovascular registries across over 2,400 hospitals within the United States. The document describes the structure, processes, and protocols for conducting cardiovascular outcomes research using the NCDR registries but does not present clinical trial results or effect sizes.
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