Initial experience with the Cardiva Boomerang vascular closure device in diagnostic catheterization.
OBJECTIVE
The authors studied the safety and efficacy of the Cardiva Boomerang vascular closure device in patients undergoing diagnostic cardiac catheterization.


BACKGROUND
Conventional vascular closure devices (sutures, collagen plugs, or metal clips) have been associated with catastrophic complications including arterial occlusion and foreign body infections; furthermore, they cannot be utilized in patients with peripheral vascular disease or vascular access site in a vessel other than the common femoral artery. The Cardiva Boomerang device facilitates vascular hemostasis without leaving any foreign body behind at the access site, can be used in peripheral vascular disease, and can be used in vessels other than the common femoral artery


METHODS
A total of 96 patients undergoing transfemoral diagnostic cardiac catheterization were included in this study, including 25 (26%) patients with contraindications to conventional closure devices. Femoral angiography was performed prior to deployment of the Cardiva Boomerang closure device. Patients were ambulated at 1 hr after hemostasis was achieved.


RESULTS
The device was successfully deployed and hemostasis achieved with the device alone in 95 (99%) patients. The device failed to deploy in 1 (1%) patient and required conversion to standard manual compression. Minor complications were observed in 5 (5%) patients. No patients experienced major complications including femoral hematoma > 4 cm, red blood cell transfusion, retroperitoneal bleed, arteriovenous fistula, pseudoaneurysm, infection, arterial occlusion, or vascular surgery.


CONCLUSIONS
The Cardiva Boomerang device is safe and effective in patients undergoing diagnostic cardiac catheterization using the transfemoral approach, facilitating early ambulation with low rates of vascular complications.
Doyle
Brendan J
BJ
Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota 55905, USA.
Godfrey
Michael J
MJ
Lennon
Ryan J
RJ
Ryan
James L
JL
Bresnahan
John F
JF
Rihal
Charanjit S
CS
Ting
Henry H
HH
D006328:Cardiac Catheterization; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D005263:Femoral Artery / Q000601:surgery*; D006331:Heart Diseases / Q000175:diagnosis*; D006489:Hemostatic Techniques / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011677:Punctures / Q000295:instrumentation; D016896:Treatment Outcome