Purpose Vascular access is an area where little has changed in the past decade. Multiple devices currently available promise shorter patient recovery times with the use of sutures or plugs in the arteriotomy site. Risk of infection, inadvertent arterial embolization, as well as patient discomfort are known issues and limitations that the neurointerventionalist must weight before using these materials. We present a device built on a different concept, that truly changes the way we access a vessel. The Axera (Arstasis, Redwood City, CA) device changes the Seldinger's technique as it creates a shallow, 10° puncture angle. By doing so it attempts to reduce manual compression time to complete hemostasis as well as patient bed elevation and ambulation times, without any implants. The purpose of our study is to evaluate the efficacy of Axera in reducing manual compression time needed to obtain hemostasis as well as possible reductions in time needed to achieve 30° bed elevation and ambulation after vascular neuroradiological procedures, in comparison to published data.
Materials and Methods Within the past 5 months, 83 patients have been enrolled. All procedures were performed in our angio suites, equipped with the Siemens Artis Zee biplane system. Vascular access using Axera was gained to common femoral arteries using standard 5 or 6-french sheaths. After sheath removal, time to obtain hemostasis from manual compression was recorded. Attempt to elevate the bed to 30° was made at 15 min and to walk, at 1 h. Recent use of anticoagulants, Plavix or Aspirin was analyzed.
Results 83 patients were enrolled and had 95 Axera accesses in a 5 months period. 51 were females (61.44%) and 32 males (38.55%) between 15 and 86 years old (average 58.6 years). Bed elevation to 30° at 15 min and ambulation at 1 h were successful in all otherwise healthy patients. Recent use of anti-platelet agents and Heparin (average 3693 units) was observed in 20 and 62 procedures, respectively. Intra-arterial stroke treatment with use of 6 and 9 mg of TPA was performed in two patients. Average time to hemostasis was 4.7 min (2–12). Amongst 29 patients that received no recent heparin or antiplatelets, median time to hemostasis was 4 min. Patients that were able to have their beds elevated to 30° and walk did so in 15 min and 1 h, respectively. One patient on full heparin dose developed a 3 cm hematoma, 3 h after the procedure, with the sheath still in the vessel. We saw a 2.09% rate of technical failure. No other device related complications were observed in our series.
Conclusion Axera vascular access system demonstrates significant reduction in manual compression and ambulation times, in comparison to standard manual compression and some closure devices, without a significant increase in complications. These advantages over traditional access techniques may result in markedly improved patient comfort, faster room and recovery area turnover time, potentially saving costs and increasing patient satisfaction.
Competing interests M Fortes: Arstasis, Inc. A Polifka: None. G Jindal: None. D Gandhi: Arstasis, Inc.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.