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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.
Insights
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.
Aim:
The aim of this prospective, multicentre, observational study was to compare the efficacy and safety of balloon-based and non-balloon-based vascular closure devices (VCDs).
Materials And Methods:
From March 2021 to May 2022, 2373 participants from 10 different centres were enrolled. Among them, 1672 patients with 5-7 Fr accesses were selected. Successful haemostasis, failure and safety were evaluated. Successful haemostasis was defined as the possibility to obtain complete haemostasis with the use of VCDs, without any complication. Failure management was defined as the need of manual compression. Safety was defined as the rate of complications. Cases of haematomas/pseudoaneurysms (PSA) and artero-venous fistula (AVF) were collected.
Results:
VCDs mechanism of action is statistically significant associated with the outcome. Non-balloon-based VCDs demonstrated a statistically significant better outcome: successful haemostasis was obtained in 96.5% vs. 85.9%, of cases when compared to balloon occluders (p < 0.001). The incidence of AVF was statistically more frequent using non-balloon occluders devices (1.57% vs 0%, p: 0.007). No significant statistical difference was found in comparing haematoma and PSA occurrence. Thrombocytopenia, coagulation deficit, BMI, diabetes mellitus and anti-coagulation were demonstrated to be independent predictors of failure management.
Conclusion:
Our study suggests a better outcome with the same complication rate, except that for AVF incidence for non-balloon collagen plug device if compared to balloon occluders vascular closure devices.
