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Obesity: an independent risk factor for insufficient hemostasis using the AngioSeal vascular closure device after
Peter Minko1, Marcus Katoh, Stefan Gräber
1Department of Diagnostic and Interventional Radiology, University Hospital Saarland, Homburg/Saar, Germany. peterminko@yahoo.com
Insights
Obesity is a risk factor for AngioSeal device failure in femoral artery closure. This vascular closure device had an 81% success rate, with kinks causing 8% of failures.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Medical Device Technology
Background:
- Vascular closure devices (VCDs) are crucial for hemostasis after femoral artery access.
- The AngioSeal device is a commonly used VCD for achieving rapid closure.
- Understanding factors influencing VCD efficacy is vital for patient outcomes.
Purpose of the Study:
- To evaluate the efficacy of the AngioSeal VCD following antegrade common femoral artery (CFA) puncture.
- To identify patient-specific factors associated with AngioSeal device failure.
Main Methods:
- A prospective study enrolled 120 patients undergoing lower limb vascular interventions with antegrade CFA access.
- AngioSeal devices (6F or 8F) were used for hemostasis post-intervention.
- Patient data including coagulation status, BMI, and groin characteristics were collected.
Main Results:
- Hemostasis was achieved in 81% of patients; 10% required manual compression for bleeding.
- Device-related failures occurred in 8% due to sheath kinking and 2% due to anchor dislodgement.
- Unsuccessful sealing was significantly associated with higher Body Mass Index (BMI).
Conclusions:
- Obesity (elevated BMI) is an independent risk factor for AngioSeal device failure.
- Sheath kinking is a significant technical complication impacting hemostasis.
- Optimizing VCD use requires consideration of patient BMI and potential device-related issues.
Purpose:
This study was designed to investigate the efficacy of the AngioSeal vascular closure device after antegrade puncture of the femoral artery.
Methods:
In a prospective study, 120 consecutive patients underwent lower limb vascular intervention by an antegrade access to the common femoral artery (CFA). After intervention, a 6F (n = 88) or an 8F (n = 32) AngioSeal vascular closure device was used to achieve hemostasis. The technical success or the cause of failure was documented. In addition, the coagulation status (platelets, INR, prothrombin time, atrial thromboplastin time (PTT)), hypertonus, locoregional habitus of the groin, body mass index (BMI), presence of calcifications, and history of previous surgical interventions of the CFA were evaluated.
Results:
Hemostasis was achieved in 97 patients (81%). In 12 patients (10%), persistent bleeding of the puncture site required manual compression. In another nine patients (8%) a kink of the sheath obviated the passage of the collagen plug toward the vessel, and in two patients the anchor dislodged out of the vessel, requiring manual compression. There were no significant differences between the groups of successful and unsuccessful sealing regarding the mean platelets (241 vs. 254 * 10(9)/l; P = 0.86), INR (1.06 vs. 1.02; P = 0.52), prothrombin time (90% vs. 90%; P = 0.86), and PTT (30 vs. 31 s; P = 0.82). However, unsuccessful sealing was more likely in obese patients with an increased BMI (26.6 vs. 28.8 kg/m(2); P = 0.04).
Conclusions:
Obesity seems to be an independent risk factor for insufficient sealing using the AngioSeal vascular closure device after antegrade puncture of the CFA. In 8% of our patients, hemostasis could not be achieved due to kink of the flexible sheath.
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