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Procedure-Related Complication Rates With the Use of Vascular Closure Devices; Does Size Only Matter? A Large Single
Sifut Sethi1, Jakub Michalski1, Rand Moh'd Elayyan Al-Shboul1
1Interventional Radiology Unit, Norfolk and Norwich University Hospitals, Norwich, UK.
Insights
Vascular closure devices (VCDs) like Angio-seal and ProGlide showed varying safety profiles. ProGlide had higher failure rates, and procedure-specific factors, not just sheath size, impact VCD success.
Area of Science:
- Interventional Radiology
- Vascular Surgery
- Medical Devices
Background:
- Vascular closure devices (VCDs) are crucial for haemostasis after femoral artery access.
- Assessing the safety and efficacy of different VCDs is essential for patient outcomes.
- Collagen-based (Angio-seal) and suture-based (ProGlide) devices are commonly used.
Purpose of the Study:
- To compare complication and deployment failure rates of Angio-seal and ProGlide VCDs.
- To evaluate the impact of procedure-specific factors on VCD performance.
- To assess VCD safety in a large single-centre Interventional Radiology (IR) department.
Main Methods:
- Retrospective analysis of 1321 VCD deployments over 6 years.
- Data collected included patient demographics, procedure type, puncture mode, and sheath size.
- Complications (haematoma, pseudoaneurysm, limb occlusion) and deployment failures were recorded and analyzed.
Main Results:
- ProGlide demonstrated a significantly higher deployment failure rate than Angio-seal for sheath sizes ≤8 Fr (P<0.001).
- Haematoma rates were higher after angioplasty procedures compared to embolisation (P=0.003, P=0.001).
- Deployment failure increased when heparin was used during procedures (P=0.005).
Conclusions:
- Sheath size is not the sole determinant of VCD success; procedure-specific factors play a significant role.
- A holistic approach to VCD deployment strategies is recommended.
- Further research into confounding variables is needed to optimize patient outcomes with VCDs.
Introduction:
Our retrospective study aimed at assessing safety of vascular closure devices (VCDs) used in a large single-centre Interventional Radiology (IR) department. Complication and deployment failure rates using collagen-based (Angio-seal) and suture-based (ProGlide) devices for common femoral artery haemostasis were compared.
Materials And Methods:
Data from VCDs deployed over a 6-year period were retrospectively analysed for patient age, procedure indication, puncture mode (antegrade/retrograde), sheath size, deployment failure and complications (haematoma, pseudoaneurysm formation, limb occlusion). Numerical and statistical analysis was undertaken.
Results:
Overall, 1321 common femoral artery punctures in 1217 patients were closed using VCDs. Failure rate using ProGlide was significantly higher when compared with Angio-seal (P=<0.001) in sheath sizes ≤8 Fr. Heparin was not administered in embolisation procedures compared with angioplasty with or without stenting. Therefore, haematoma tended to occur more frequently following angioplasty without stenting (P = 0.003) and angioplasty with stenting (P = 0.001), when compared with embolisation. Deployment failure occurred more frequently when heparin was used during the procedure (P = 0.005).
Conclusion:
Although complications relating to sheath size are well established in the literature, there remains a paucity of data assessing the impact of procedure specific factors when comparing VCDs. Our study challenges that size is the sole determinant of VCD success and invites a more holistic view of VCD deployment strategies. This study advocates continued research into the nuances of other potential confounding variables to optimise patient outcomes.
