Efficacy and time-to-hemostasis of antegrade femoral access closure using the ExoSeal vascular closure device: a retrospective single-center study

J M Boschewitz, C C Pieper, M Andersson, J Nadal, H H Schild, C Meyer
European Journal of Vascular and Endovascular Surgery 2014, 48 (5): 585-91

OBJECTIVE: To retrospectively evaluate the efficacy and time-to-hemostasis of antegrade femoral access closure using the ExoSeal vascular closure device (VCD).

DESIGN: Retrospective, single-center analysis.

MATERIALS AND METHODS: Between September 2010 and February 2013, 148 ExoSeal VCD closures (5-7F) of antegrade femoral accesses were performed in 119 patients (70 males, mean age 71.6 years, range 40-97 years). In all cases initial diagnostic angiography was performed via an 18G/3.8F retrograde femoral access, which was left in place during intervention (in-house standard) and was used to obtain control angiography after successful closure of the antegrade access to determine hemostasis. Technical device success was defined as ExoSeal closure without major VCD-related complications; procedural success as hemostasis within 5 minutes. Statistical analysis was performed using a logistic regression model and correlation analyses.

RESULTS: 145/148 (98.0%) ExoSeal closures were technically successful (5F: n = 76; 6F: n = 65; 7F: n = 7). Angiographic control showed closure after 2 minutes in 130/145 cases. In a further 14 cases hemostasis was achieved after an additional 3 minutes MC, so that closure was successful within 5 minutes in 144/148 cases (97.3%). No major complication occurred. One minor complication was recorded in a 6F access case. Pre-interventional activated partial thromboplastin time (aPTT) was the only statistically significant predictor of necessary manual compression (MC) > 2 minutes (p = .01), but with an odds-ratio of only 1.038. The INR showed an odds-ratio of 2.455 for need for 5 minutes MC (NS). Significant correlations were found between the need for 5 minutes MC and medication with acetylsalicylic acid (p = .01), clopidogrel (p < .01), and abciximab (p < .001).

CONCLUSION: ExoSeal vascular closure of antegrade femoral punctures is safe and effective with a low complication rate. Two minutes of MC are sufficient to achieve hemostasis in the majority of cases. However, in patients on antiplatelet therapy, especially after abciximab, the authors advocate prolonging MC to 5 minutes.

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