980-38 A Randomized Study of the 8 French Hemostatic Puncture Closure Device vs Manual Compression After Coronary Interventions

• Published in: Journal of the American College of Cardiology 1995-02, Vol.25 (2), p.262A-262A
• Main Authors: Blengino, Simonetta, Hann, Brenda, Maiello, Luigi, Nakamura, Shigeru, Hall, Patrick, Biagi, Giancarlo, Finci, Leo, Colombo, Antonio
• Format: Article
• Language: English
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/0735-1097(95)92548-J

The hemostatic puncture device (HPCD Kensey-Nash Co.) is a collagen plug system with an intraarterial anchor, To assess its efficacy, 56 patients were randomized after BF percutaneous transcatheter interventions to either manual compression (MC) (25 patients) or HPCD (29 patients). There was no significant difference in the base line characteristics of age, gender, diabetes and hypertension between the two groups. Successful hemostasis was defined as the achievement of hemostasis without femoral hematoma, blood transfusion or vascular repair. Type of procedures, systolic blood pressure (BP), activating clotting time (ACT). total hemostasis duration, time to mobilization and hospital stay after the removal of the sheath were compared. Ultrasound vessel measurements made at the puncture site after the procedure and 2 months follow up (F/U) were also compared.MC (n=25)HPCD (n=29)p ValueSuccessful hemostasis24 (96%)26 (90%)0.71Stent implantation20 (80%)27 (93%)0.30Systolic BP (mmHg)129±9134±180.34ACT (seconds)163±17274±610.0001Hemostasis time (minutes)16±52±60.0001Time to mobilization (hr)18.1±3.615.8±3.30.018Hospital stay (day)1.2±0.41.1±0.40.22Vessel diameter (mm)7.9±1.67.9±2.20.93Vessel at F/U (mm)7.6±1.07.7±1.10.69 There was 1 unsuccessful hemostasis due to hematoma in the MC and 2 in the HPCD group. There was one rebleeding episode requiring prolonged manual pressure in the HPCD group. All stent patients were treated without subsequent anticoagulation. The device anchor in the vessel was small enough that it did not reduce the vessel diameter by ultrasound. This result was confirmed also at 2 month ultrasound follow up. (1) The HPCD provides rapid hemostasis despite a high ACT. (2) HPCD enables prompt sheath removal despite effective anticoagulation and also reduces the effort of manual compression. (3) HPCD use allows for a reduction in mobilization time and short hospital stay.