Novel femoral artery puncture closure device in patients undergoing interventional and diagnostic cardiac procedures.
BACKGROUND
The wide range of closure devices for arterial access sites still leaves room for improvement.


RESULTS
We report our initial experience with a novel, cost-effective, suture-mediated device (6 French X-PRESS device, X-SITE Medical, Blue Bell, Pennsylvania) for closure of the arterial access site after both diagnostic and therapeutic interventions. A total of 51 consecutive patients are reported. The closure was performed immediately after the procedure. No patient had more than 5,000 U heparin administered during the procedure. The closure device was used in 36 patients (73%) after diagnostic angiography and in 15 patients (27%) after therapeutic intervention. The device could be successfully deployed in 48 patients (94%). In the remaining 3 cases (6%), hemostasis was achieved with standard manual compression without any further event. Immediate total hemostasis was achieved with the device in 44 of 48 patients (92%). Four devices (8%) could not be deployed correctly due to technical problems and the patients needed additional manual compression. The average time to achieve complete hemostasis was 5.5 +/- 3.5 minutes (range, 3-26 minutes). The patients were ambulated after a period of 1.3 +/- 0.4 hours of bedrest (range, 0.8-3.5 hours). Time to possible discharge was 4.2 +/- 3.4 hours (range, 0.9-12.5 hours). One patient experienced a minor complication (hematoma < 6 cm) and was treated with manual compression without clinical sequelae. Telephone follow-up was carried out 2 weeks after deployment and revealed no sequelae.


CONCLUSIONS
The 6 French X-PRESS device is safe and effective in providing rapid hemostasis following interventional or diagnostic catheterization procedures. Use of the device is associated with a low rate of complications and facilitates quick hemostasis, mobilization and discharge.
Mehta
Haresh
H
Swiss Cardiovascular Center Bern, University Hospital, 3010 Bern, Switzerland.
Fleisch
Martin
M
Chatterjee
Tushar
T
Windecker
Stephan
S
Garachermani
Ali
A
Eberli
Franz R
FR
Meier
Bernhard
B
D000368:Aged; D006348:Cardiac Surgical Procedures / Q000295:instrumentation*; D003935:Diagnostic Techniques, Cardiovascular; D004434:Early Ambulation; D004867:Equipment Design / Q000295:instrumentation; D004869:Equipment Safety / Q000295:instrumentation; D005260:Female; D005263:Femoral Artery / Q000601:surgery*; D005500:Follow-Up Studies; D006488:Hemostasis, Surgical / Q000295:instrumentation; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011677:Punctures / Q000295:instrumentation*; D013536:Suture Techniques / Q000295:instrumentation; D016896:Treatment Outcome