TY - JOUR T1 - Impact of early surveillance on safety signal identification in the CathPCI DELTA study JF - BMJ Surgery, Interventions, & Health Technologies DO - 10.1136/bmjsit-2020-000047 VL - 2 IS - 1 SP - e000047 AU - Arjun Majithia AU - Michael E Matheny AU - Sourbha S Dani AU - Jessica K Paulus AU - Danica Marinac-Dabic AU - Susan Robbins AU - Henry Ssemaganda AU - Kathleen Hewitt AU - Angelo Ponirakis AU - Nilsa Loyo-Berrios AU - Issam Moussa AU - Joseph Drozda AU - Sharon-Lise Normand AU - Frederic S Resnic Y1 - 2020/11/01 UR - http://sit.bmj.com/content/2/1/e000047.abstract N2 - Objectives The CathPCI Data Extraction and Longitudinal Trend Analysis study was designed to determine the feasibility of conducting prospective surveillance of a large national registry to perform comparative safety analyses of medical devices. We sought to determine whether the complementary use of retrospective case data could improve safety signal detection time.Design We performed a simulated surveillance study of the comparative safety of the Mynx vascular closure device (VCD) with propensity score matched alternate VCD recipients, using both retrospective and prospective cohort data.Setting Centers within the USA using the National Cardiovascular Data Registry (NCDR) CathPCI Registry.Participants Percutaneous coronary intervention cases captured within the NCDR CathPCI Registry from July 1, 2009 to September 30, 2013 were included in the analysis.Interventions None.Main outcome measures Absolute and relative risk (RR) of any vascular complication (a composite of bleeding at access site, hematoma at access site, retroperitoneal bleeding, and other vascular complications requiring treatment); time to signal detection.Results A safety alert was detected for the primary outcome of “any vascular complication” after 15 months of surveillance and was sustained for the study duration (absolute risk of any vascular complication, 1.20% vs 0.73%, RR, 1.63; 95% CI 1.50 to 1.79; p<0.001). The safety signal was identified 12 months earlier with the use of retrospective case data than during the initial study.Conclusions Prospective, active surveillance of cardiovascular registries is feasible to perform comparative analyses of medical devices. Retrospective data may complement prospective surveillance to improve time to signal detection, indicating the need for earlier prospective application of safety surveillance for devices new to the market. ER -