ArticleBMJ surgery, interventions, & health technologies2020
Impact of early surveillance on safety signal identification in the CathPCI DELTA study.
Article in BMJ surgery, interventions, & health technologies, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed, 5 citations in OpenAlex.
- Leveraging Clinical Registries and Electronic Health Systems to Advance Value-Based Medicine Across Specialties.The Permanente journal · 2026Review
- Building Real-World Evidence Infrastructure to Improve Health and Healthcare in the United States: Part I-Coordinated Registry Networks and Systemic Coordinated Inter-Organizational Networks.International journal of translational medical research and public health · 2025Article
- A Statistical Framework to Detect and Quantify Operator-Learning Curves in Medical Device Safety Evaluation.Medical devices (Auckland, N.Z.) · 2025Article
- A Comprehensive Framework for Evaluating the Value Created by Real-World Evidence for Diverse Stakeholders: The Case for Coordinated Registry Networks.Therapeutic innovation & regulatory science · 2024Article
Corrections and comments
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Authors and funding
14 authors at 9 institutions in 1 country.
Funding
Abstract
objectivesThe 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.
designWe 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.
settingCenters within the USA using the National Cardiovascular Data Registry (NCDR) CathPCI Registry.
participantsPercutaneous coronary intervention cases captured within the NCDR CathPCI Registry from July 1, 2009 to September 30, 2013 were included in the analysis.
interventionsNone.
main outcome measuresAbsolute 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.
resultsA 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.
conclusionsProspective, 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.
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