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Effectiveness and Safety of Different Vascular Closure Devices: Multicentre Prospective Observational study.
Anna Maria Ierardi1, Andrea Coppola2, Matteo Renzulli3
1UOC Radiologia, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Via Francesco Sforza 35, 20122, Milan, Italy. amierardi@yahoo.it.
Cardiovascular and Interventional Radiology
|May 24, 2023
Summary
Non-balloon vascular closure devices (VCDs) show superior efficacy for achieving successful hemostasis compared to balloon-based VCDs. While non-balloon VCDs had a higher incidence of arteriovenous fistula (AVF), overall complication rates were similar.
Area of Science:
- Interventional Cardiology
- Vascular Surgery
- Medical Device Technology
Background:
- Vascular closure devices (VCDs) are crucial for sealing arterial access sites after procedures.
- Comparing the efficacy and safety of different VCD types is essential for optimizing patient care.
Purpose of the Study:
- To prospectively compare the efficacy and safety of balloon-based versus non-balloon-based vascular closure devices.
- To identify factors influencing the success and failure of VCDs.
Main Methods:
- A prospective, multicentre observational study involving 1672 patients with 5-7 Fr accesses.
- Evaluation of successful hemostasis, failure (requiring manual compression), and complication rates (hematoma, pseudoaneurysm, arteriovenous fistula).
Main Results:
- Non-balloon VCDs achieved significantly higher successful hemostasis rates (96.5%) compared to balloon-based VCDs (85.9%).
- Arteriovenous fistula (AVF) incidence was higher with non-balloon VCDs (1.57% vs. 0%).
- Hematoma and pseudoaneurysm rates were similar; thrombocytopenia, coagulation deficit, BMI, diabetes, and anticoagulation predicted failure.
Conclusions:
- Non-balloon VCDs offer better hemostasis outcomes than balloon-based devices.
- While AVF risk is higher with non-balloon VCDs, overall complication profiles are comparable, suggesting their utility.
