Cardiva Catalyst II vascular access management device in percutaneous diagnostic and interventional procedures with same-day discharge (Catalyst II trial).

摘要

PURPOSE: 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. CONCLUSION: 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.