Gelatin sponge closure device versus manual compression after peripheral arterial catheterization procedures.
OBJECTIVE
To evaluate the safety and efficacy of the QuickSeal system, which delivers an over-the-wire extravascular porcine gelatin sponge (nonbovine and noncollagen), compared with manual compression in a single interventional radiology practice.


METHODS
This single-institution report involves 141 patients undergoing peripheral diagnostic and interventional procedures in a teaching and private-practice setting. A 3:2 device-to-control ratio was used with randomization stratified by type of procedure, interventional or diagnostic. Primary endpoints included time to hemostasis (TTH), time to ambulation (TTA), and rate of major complications. Sheaths were removed in the device group when activated clotting times (ACTs) were < or =300 seconds for patients without glycoprotein (GP) IIb/IIIa platelet inhibitors and < or =250 seconds for patients with GP IIb/IIIa platelet inhibitors. Sheaths were removed in the control group when ACTs were < or =180 seconds.


RESULTS
The mean TTH was significantly shorter (P <.001) in the device group (8.2 minutes) than in the control group (14.12 minutes). Mean TTA was shorter in the device group (2.7 hours) than in the control group (7.1 hours), and the time to discharge was shorter in the device group (23.8 hours) than in the control group (43.6 hours). There were no major complications in either group, and the incidences of minor complications were not significantly different.


CONCLUSIONS
The tested device reduced TTH, TTA, and eligibility for hospital discharge while maintaining a safety profile equivalent to that of manual compression in diagnostic and interventional procedures.
Castañeda
Flavio
F
Radiology Department, University of Illinois College of Medicine at Peoria, 1 Illini Drive, Box 1649, Peoria, IL 61656, USA. flavio@miit.com
Swischuk
James L
JL
Smouse
H Bob
HB
Brady
Terry
T
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002406:Catheterization, Peripheral / Q000009:adverse effects / Q000191:economics / Q000295:instrumentation*; D004434:Early Ambulation; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery; D005781:Gelatin Sponge, Absorbable; D006489:Hemostatic Techniques / Q000295:instrumentation; D006490:Hemostatics; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011312:Pressure; D015641:Radiography, Interventional / Q000009:adverse effects / Q000191:economics / Q000295:instrumentation*; D014914:Whole Blood Coagulation Time
D006490:Hemostatics