Abstract
Objectives
Endovascular treatment (EVT) of lower extremity artery disease (LEAD) is minimally invasive and has good safety and efficacy. Puncture site complications are common in EVT, but these and the hemostatic time have been reduced by newer hemostatic devices such as ExoSeal. However, factors affecting poor outcomes after use of ExoSeal are unclear. Therefore, the purpose of this study is to identify these factors after ExoSeal deployment in EVT.
Material and Methods
A retrospective study was performed for 868 cases in which hemostasis was attempted using ExoSeal between 2019 and 2023. Factors affecting deployment failure and prolonged hemostatic time after ExoSeal were assessed.
Results
The 868 subjects (569 males, 66%) had a median age of 77 [72-83] years. A femoral antegrade approach was used in 548 cases (63%), with use of a 6Fr sheath in most cases (99%). The lesions were in the femoropopliteal (n = 387, 44%) and infrapopliteal (n = 359, 41%) arteries. The technical success rate of EVT was 97%. ExoSeal was successfully deployed in 812 cases (94%). Cases in which ExoSeal deployment was unsuccessful had significantly more frequent proximal stenting (9% vs 20%, P = .01). In the entire cohort, there were 6 (.69%) puncture site complications. Of the 812 cases with successful deployment, the manual compression hemostasis time was prolonged (>10 min) in 51 cases (6%). Hemostatic time was significantly prolonged in cases with proximal stenting or intimal thickening at the puncture site (both, P < .001).
Conclusion
These results show that ExoSeal is a useful device. However, deployment failure and prolonged hemostatic time were caused by a proximal stent or intimal thickening of the puncture site, and use of hemostatic devices in such cases requires further investigation.
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