Totally Extravascular Bioresorbable Closure Reduces Access Complications after Endovascular Peripheral Intervention.

Area of Science:

• Vascular Surgery
• Interventional Cardiology
• Medical Device Technology

Background:

• Percutaneous closure of access arteries is standard after endovascular procedures.
• Plaque-laden and stenotic access arteries in peripheral vascular disease pose challenges for puncture site control.
• Ischemic complications are more frequent in these patients, especially with intraluminal devices.

Purpose of the Study:

• To evaluate the efficacy of totally extravascular bioresorbable closure (TEBC) for femoral artery puncture sites.
• To compare TEBC with manual compression (MC) after percutaneous peripheral intervention (PPI).

Main Methods:

• Retrospective analysis of 507 consecutive PPIs (2015-2020) at a single institution.
• Comparison of complication rates between TEBC (25%) and MC (75%) using multivariate regression.
• Major complications: acute arterial ischemia, major bleeding, or pseudoaneurysm requiring surgery.
• Minor complications: transient hypotension, groin hematoma, or arteriovenous fistula.

Main Results:

• No acute arterial ischemia observed with TEBC, compared to 1.3% with MC.
• No significant difference in major complications (OR = 1.45; P = 0.66).
• TEBC significantly reduced minor access complications (OR = 0.39; P < 0.01).

Conclusions:

• TEBC is a safe and effective closure method for femoral artery access in PPI for peripheral arterial disease.
• TEBC eliminates the risk of acute arterial ischemia and reduces minor complications.
• The bioresorbable, non-intraluminal nature of TEBC makes it ideal for this patient population.