Safeguard pressure assisted device for local femoral hemostasis in neuroendovascular procedures: A single center study of 879 patients - 08/12/20
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Highlights |
• | The percutaneous femoral approach represents the most commonly used route for neuroendovascular procedures. |
• | Its management is crucial to safe and procedure completion but also for the preservation of this route in the time of secondary artery puncture need. |
• | Safeguard® 24 cm pressure assisted device has been developed for local hemostasis of the femoral artery after brief manual compression. |
• | The use of an extracorporeal device, in comparison to the VCDs, could allow a greater flexibility when more sessions of femoral puncture are necessary. |
Abstract |
Background |
Various vascular closure devices (VCDs) are available for local hemostasis after percutaneous transfemoral approach for neuroendovascular procedures but they have been associated with an increased complication rate and limitations to a re-puncture of the artery. We evaluated the safety and efficacy of Safeguard® 24 cm pressure assisted device (Merit Medical, West Jordan, UT, USA) and the associated complications.
Methods |
From September 2016 to December 2019, 879 patients underwent neuroendovascular procedures via transfemoral approach using an introducer sheath ranging from 4 to 6-French and they were included in a prospective database. We registered the demographic characteristics and procedural factors. We evaluated the device failure and associated complications.
Results |
The Safeguard® was successful in 862 cases (98.1 %) with post-procedural local bleeding in 17 patients (1.9%). On univariate analysis, an association with local bleeding was observed with age >60 years (Odds ratio [OR] = 3.2, P = 0.04) and the use of an introducer sheath >4 F ([OR] = 3.1, P = 0.007). Female gender, antithrombotic medication and type of procedure (diagnostic or interventional) were not associated with local bleeding. On binary logistic regression analysis, there was association only for age >60 years ([OR] = 3, P = 0.04).
Conclusion |
The Safeguard® 24 cm is safe and efficient. It is simple to use and it can be applied independently from vessel anatomic characteristics. It should though be used with caution in case of a femoral introducer sheath larger than 4 Fr and patients older than 60 years.
El texto completo de este artículo está disponible en PDF.Keywords : Percutaneous transfemoral approach, Various vascular closer devices, Safeguard® 24 cm, Local hemostasis, Neuroendovascular
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