Are New Closure Devices Safe in PCI Procedures?

A study published June 29 in the Journal of Invasive Cardiology found that there are now "better safety profiles for most of the frequently used vascular closer devices (VCDs) compared to manual compression (MC) controls."

The authors note that previously the Food and Drug Administration (FDA) had reported serious adverse effects and deaths associated with the use of VCDs, and had collaborated with the ACC and its National Cardiovascular Data Registry (NCDR®) to analyze the closure-device related adverse events. "Analysis indicated that a higher rate of vascular complications was associated with one particular device, which was subsequently, and voluntarily, removed from the market by its manufacturer." The FDA has since approved more closure devices, so the authors aimed to "evaluate safety profiled of the most frequently used closure devices, and compare their safety profiles to manual and mechanical compression."

Additional Resources
  • (JAMA)Journal Scan: Bleeding Avoidance Strategies and Risk of Periprocedural Bleeding Among Patients Undergoing PCI
  • CardioSmart for Your Patients: Angioplasty and Stenting
  • Using data from the NCDR’s CathPCI Registry, the authors looked at 1,819,611 percutaneous coronary intervention (PCI) procedures performed at the femoral access site. "Seven types of hemostasis strategy were evaluated for rate of any bleeding or vascular complication compared to MC controls, using hierarchical multiple logistic regression analysis, controlling for demographic factors, type of hemostasis, several indices of co-morbidity, and other potential confounding variables."

    Results showed that "four of the VCDs and hemostasis patches demonstrated significantly lower bleeding or vascular complication rates than MC controls;" and "all types of hemostasis strategy, including MC, exhibited reduced complication rates over time."

    The authors conclude that "overall, the medical literature on this issue is highly consistent with the findings of this study, with VCDs generally demonstrating good performance against MC controls across a wide range of treatment groups and clinical outcomes (with the exception of retroperitoneal bleed, which was positively associated with VCD use)."

    "This experience underscores the value of investigating real-world methods of hemostasis via analysis of data collected in observational registries such as those within the NCDR," note the authors.

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