Early clinical experience with the 6 French Angio-Seal device: immediate closure of femoral puncture sites after diagnostic and interventional coronary procedures.
The objective of this study was to assess the early safety and efficacy of the novel 6 Fr Angio-Seal device for routine clinical use after diagnostic cardiac catheterization and coronary angioplasty. In a prospective study, we used the 6 Fr Angio-Seal device in 180 consecutive patients (131 male, 49 female, mean age 60.7 years) for closure of femoral arterial puncture sites immediately after diagnostic (n = 108) or interventional (n = 72) coronary procedures independent of the coagulation status. All patients were monitored for 24 hr after the procedure and followed for 30 days. The closure device was successfully deployed in 95.4% after diagnostic catheterization versus 98.6% after coronary angioplasty (P = 0.963). Immediate hemostasis was achieved in 91.5% versus 90.1% of the patients (P = 0.993). Major complications were observed 1.9% versus 2.8% of the patients (P = 0.885). During 30-day follow-up, no late events or complications were reported. The 6 Fr Angio-Seal device is a safe and effective device that allows for immediate closure of femoral puncture sites after both diagnostic and interventional procedures with a low rate of major complications.
Eggebrecht
H
H
Department of Cardiology, Center of Internal Medicine, University Hospital Essen, Essen, Germany. holger.eggebrecht@uni-essen.de
Haude
M
M
von Birgelen
C
C
Woertgen
U
U
Schmermund
A
A
Baumgart
D
D
Kaiser
C
C
Naber
C K
CK
Kroeger
K
K
Erbel
R
R
D000328:Adult; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation; D006328:Cardiac Catheterization / Q000295:instrumentation; D013504:Cardiovascular Surgical Procedures / Q000295:instrumentation; D003327:Coronary Disease / Q000209:etiology; D003949:Diagnostic Techniques, Surgical / Q000295:instrumentation; D004869:Equipment Safety / Q000295:instrumentation; D005260:Female; D005263:Femoral Artery / Q000601:surgery; D005500:Follow-Up Studies; D006406:Hematoma / Q000209:etiology; D006489:Hemostatic Techniques / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D011677:Punctures / Q000295:instrumentation