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Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary
Eugenia Nikolsky1, Roxana Mehran, Amir Halkin
1Cardiovascular Research Foundation and the Lenox Hill Heart and Vascular Institute, New York, New York 10022, USA.
Insights
Arteriotomy closure devices (ACDs) show similar safety to mechanical compression for diagnostic angiography. However, VasoSeal devices increased complications during percutaneous coronary interventions (PCI), suggesting mechanical compression may be safer for PCI.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Device Safety
Background:
- Arteriotomy closure devices (ACDs) are frequently used for hemostasis after endovascular procedures.
- The safety of ACDs compared to traditional mechanical compression remains a subject of debate.
Purpose of the Study:
- To evaluate the safety of arteriotomy closure devices (ACDs) versus mechanical compression.
- To compare access-related complications in patients undergoing percutaneous transfemoral coronary procedures.
Main Methods:
- Meta-analysis of 30 studies (37,066 patients) including randomized, case-control, and cohort designs.
- Primary endpoint: cumulative incidence of vascular complications (e.g., pseudoaneurysm, thrombosis, infection).
- Subgroup analysis by device type (Angio-Seal, Perclose, VasoSeal) and procedure setting (diagnostic angiography vs. PCI).
Main Results:
- No significant difference in complication rates between Angio-Seal and mechanical compression in diagnostic or PCI settings.
- A trend towards fewer complications with Angio-Seal in PCI was observed in randomized trials.
- Perclose showed no difference in complication rates.
- VasoSeal was associated with an increased risk of complications in the PCI setting.
- Overall analysis favored mechanical compression over ACDs.
Conclusions:
- For diagnostic angiography, ACDs and mechanical compression have similar safety profiles regarding access-site complications.
- In percutaneous coronary interventions (PCI), the VasoSeal device demonstrated a higher complication rate compared to mechanical compression.
Objectives:
This study was designed to assess the safety of arteriotomy closure devices (ACDs) versus mechanical compression by meta-analysis in patients undergoing percutaneous transfemoral coronary procedures.
Background:
Although ACDs are widely applied for hemostasis after percutaneous endovascular procedures, their safety is controversial.
Methods:
Randomized, case-control, and cohort studies comparing access-related complications using ACDs versus mechanical compression were analyzed. The primary end point was the cumulative incidence of vascular complications, including pseudoaneurysm, arteriovenous fistula, retroperitoneal hematoma, femoral artery thrombosis, surgical vascular repair, access site infection, and blood transfusion.
Results:
A total of 30 studies involving 37,066 patients were identified. No difference in complication incidence between Angio-Seal and mechanical compression was revealed in the diagnostic (Dx) setting (odds ratio [OR] 1.08, 95% confidence interval [CI] 0.11 to 10.0) or percutaneous coronary interventions (PCI) (OR 0.86, 95% CI 0.65 to 1.12). Meta-analysis of randomized trials only showed a trend toward less complications using Angio-Seal in a PCI setting (OR 0.46, 95% CI 0.20 to 1.04; p = 0.062). No differences were observed regarding Perclose in either Dx (OR 1.51, 95% CI 0.24 to 9.47) or PCI (OR 1.21, 95% CI 0.94 to 1.54) setting. An increased risk in complication rates using VasoSeal in the PCI setting (OR 2.25, 95% CI 1.07 to 4.71) was found. The overall analysis favored mechanical compression over ACD (OR 1.34, 95% CI 1.01 to 1.79).
Conclusions:
In the setting of Dx angiography, the risk of access-site-related complications was similar for ACD compared with mechanical compression. In the setting of PCI, the rate of complications appeared higher with VasoSeal.
