title: Cardiva Catalyst II vascular access management device in percutaneous diagnostic and interventional procedures with same-day discharge (Catalyst II trial).
abstract: OBJECTIVE
  To present a prospective, single-center trial of the Cardiva Catalyst II, a vascular closure device that provides temporary hemostasis after the procedure and is removed under manual compression, leaving no material behind.
  
  
  METHODS
  During a 16-month period between April 2008 and July 2009, 400 procedures (100 interventions, 300 diagnostic procedures) were performed on 351 nonconsecutive patients (185 men; mean age 60.2 ± 12.0 years, range 27-93). All interventions were performed utilizing bivalirudin for anti-thrombin therapy. Initial follow-up was done at a mean 1.3 ± 0.7 days after the index procedure in all patients. Final follow-up, for diagnostic procedures as well as interventions, was performed at a mean 15.4 ± 7.1 days. The primary and secondary endpoints were the rate of major and minor vascular complications, respectively.
  
  
  RESULTS
  Successful deployment of the device was reported in 397 (99.3%) procedures, which were primarily in retrograde fashion (97.0%) from the right groin (92.5%). In most cases (309, 77.2%), a 5-F sheath was used. A major vascular complication occurred after 1 intervention; none was noted after diagnostic procedures. Minor vascular complications were recorded after 2 interventions and 5 diagnostic procedures. Overall vascular complication rates were 0.25% for major sequelae and 1.75% for minor events. Mean time to discharge after diagnostic procedures was 145.0 ± 21.2 minutes versus 295.1 ± 44.1 minutes after interventional procedures (p < 0.05). There was no death, stroke, myocardial infarction, or urgent hospital transfer in the study cohort.
  
  
  CONCLUSIONS
  Cardiva Catalyst is safe and effective device in achieving local hemostasis after percutaneous diagnostic procedures and interventions performed under bivalirudin anticoagulation. The use of this device with an appropriate protocol facilitates same-day discharge.
authors.affiliation: San Antonio Endovascular & Heart Institute, San Antonio, Texas 78258, USA. rs.kiesz@sbcglobal.net
authors.forename: R Stefan
authors.initials: RS
authors.lastname: Kiesz
authors.forename: Barbara K
authors.initials: BK
authors.lastname: Wiernek
authors.forename: Szymon L
authors.initials: SL
authors.lastname: Wiernek
authors.forename: Charlotte
authors.initials: C
authors.lastname: Merritt
authors.forename: Tomas
authors.initials: T
authors.lastname: Ybarra
authors.forename: Adam
authors.initials: A
authors.lastname: Iwanski
authors.forename: Piotr P
authors.initials: PP
authors.lastname: Buszman
authors.forename: Radoslaw
authors.initials: R
authors.lastname: Szymanski
authors.forename: Jack L
authors.initials: JL
authors.lastname: Martin
authors.forename: Pawel E
authors.initials: PE
authors.lastname: Buszman
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002406:Catheterization, Peripheral / Q000009:adverse effects*; D016009:Chi-Square Distribution; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery; D006470:Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D006489:Hemostatic Techniques / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010351:Patient Discharge; D011446:Prospective Studies; D011677:Punctures; D018570:Risk Assessment; D013781:Texas; D013997:Time Factors; D016896:Treatment Outcome