Use of a novel access technology for femoral artery catheterization: results of the RECITAL trial

Abstract

Objective: To present results of a registry of a novel vascular access device.

Background: Arterial access has been largely unchanged for 60 years. The Arstasis device creates a novel shallow-angle arterial access designed to facilitate hemostasis without use of a vascular closure device (VCD) or implantation of a foreign body for closure. This is the first publication to report the outcomes of Arstasis access.

Methods: Patients (n = 346) underwent routine diagnostic cardiac catheterization (Dx) at 8 sites in the United States. Patients were assessed for device success, time to hemostasis (TTH), early sit up, time to ambulation (TTA), time-to-discharge-eligibility (TTDe) as well as safety; 249 patients had Dx only, 97 crossed over to PCI.

Results: Device deployment was successful in 97%; the other 3% converted to routine access. Mean TTH and TTA for Dx were 4.0 ± 2.5 minutes and 1.5 ± 1.2 hours, respectively; for PCI it was 6.9 ± 5.1 minutes and 3.2 ± 3.3 hours. A subset of 245 patients (72.9%) sat up within 30 minutes after hemostasis; early sit-up was successful in all but 1 (99.6%). TTDe for Dx was 2.7 ± 1.6 hours. There were no major access-site related complications; minor complications were primarily subclinical hematomas in 1.2%.

Conclusions: Arstasis access is associated with short TTH and TTA, early sit up after sheath pull, and accelerated TTDe, achieved without use of VCDs or implantation of a foreign body, with high success and minimal complication rates.

Trial registration: ClinicalTrials.gov NCT01271946.