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Abstract

Prospective, Real-Life Evaluation of a Low-Angle Arterial Entry Closure Device for Endovascular, Outpatient-Based Interventions Using the Arstasis AXERA® 2 System (AXCELERATE Trial)

Background: The purpose of the AXCELERATE study was to evaluate the safety and efficacy of the AXERA® 2 vascular closure device in patients undergoing endovascular therapeutic arterial interventions.

Methods: A single-center, single-operator, prospective observational study was performed over 15-months in consecutive patients undergoing outpatient-based, endovascular procedures using the AXERA® 2 device. Diagnostic procedures only were excluded. The primary endpoints were hemostasis success, time to hemostasis (TTH), early (< 60 minutes) sit up time (TTS), time to ambulation (TTA), time to discharge (TTD) and access-related complications.

Results: A total of 105 arterial consecutive procedures were included. The mean age was 73.8 years (55.2% males). The vast majority of procedures were performed by using 6- and 7-French sheaths (48.6% each) and mostly due to ischemic rest pain (35.2%). Heparin was given in all cases and 85.7% were taking an antiplatelet or anticoagulant agent at procedural time. The median TTH was 14.8 minutes of manual compression. Early sit up was accomplished in 80.2% of patients with no complications. The average TTA was 2.4 hours and the TTD was 3.8 hours. A total of 97.1% of patients were discharged without access-related problems and in good clinical condition upon procedural completion. Fourteen complications were seen (13 patients), all of them hematomas > 6-cm (13.3%). Four patients required hospital admission after their interventions (3.8%), 2 required blood transfusions (1.9%) and 2 developed pseudoaneurysms (1.9%). No infectious, vascular thrombotic or other access-related complications were seen during a median follow-up of 117 days. When complications were analyzed with respect to the quartile of occurrence, no statistical differences where found (p>0.05 for all quartiles).

Conclusions: The AXCELERATE trial shows that the use of the AXERA® 2 device reduces TTS, TTA and TTD, while being a safe and effective method of hemostasis for outpatient-based interventions.


Author(s):

Eduardo Espinoza, Courtney Harris, Napoleon Cieza-Rubio, John P Pacanowski and Luis R Leon



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