Cardiva Catalyst II Vascular Access Management Device in Percutaneous Diagnostic and Interventional Procedures with Same-Day Discharge (CATALYST II Trial)

• Published in: Journal of endovascular therapy 2011-02, Vol.18 (1), p.46-53
• Main Authors: Kiesz, R. Stefan, Wiernek, Barbara K., Wiernek, Szymon L., Merritt, Charlotte, Ybarra, Tomas, Iwanski, Adam, Buszman, Piotr P., Szymanski, Radoslaw, Martin, Jack L., Buszman, Pawel E.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Catheterization, Peripheral - adverse effects; Catheters; Chi-Square Distribution; Clinical medicine; Collagen; Equipment Design; Female; Femoral Artery; Hemophilia; Hemorrhage - etiology; Hemorrhage - prevention & control; Hemostatic Techniques - adverse effects; Hemostatic Techniques - instrumentation; Hospitals; Humans; Male; Medical imaging; Middle Aged; Patient Discharge; Prospective Studies; Punctures; Risk Assessment; Texas; Time Factors; Treatment Outcome; Veins & arteries
• ISSN: 1526-6028; 1545-1550
• DOI: 10.1583/10-3237.1

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 145.0621.2 minutes versus 295.1±44.1 minutes after interventional procedures (p