title: 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.
authors.affiliation: Cooper University Hospital, One Cooper Plaza D-427, Camden, NJ 08103 USA. Turi-zoltan@cooperhealth.edu
authors.forename: Zoltan G
authors.initials: ZG
authors.lastname: Turi
authors.forename: Dale C
authors.initials: DC
authors.lastname: Wortham
authors.forename: Gregory C
authors.initials: GC
authors.lastname: Sampognaro
authors.forename: Frank D
authors.initials: FD
authors.lastname: Kresock
authors.forename: John S
authors.initials: JS
authors.lastname: Held
authors.forename: Ray D
authors.initials: RD
authors.lastname: Smith
authors.forename: Kalyan K
authors.initials: KK
authors.lastname: Veerina
authors.forename: Tomoaki
authors.initials: T
authors.lastname: Hinohara
authors.forename: Amir
authors.initials: A
authors.lastname: Kaki
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery; D006406:Hematoma / Q000209:etiology / Q000517:prevention & control*; D006489:Hemostatic Techniques / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011677:Punctures / Q000295:instrumentation; D012042:Registries; D062666:Vascular Access Devices; D016138:Walking; D055815:Young Adult