SHEATH PULLING IMMEDIATELY AFTER PTCA - COMPARISON OF 2 DIFFERENT DEPLOYMENT TECHNIQUES FOR THE HEMOSTATIC PUNCTURE CLOSURE DEVICE - A PROSPECTIVE, RANDOMIZED STUDY

Sheath pulling immediately after percutaneous transluminal coronary an gioplasty (PTCA) increases patients' comfort, decreases burden for the medical staff, and may reduce hospital costs by shortening the length of stay, Immediate sheath pulling in anticoagulated patients with a l ow risk of bleeding complications is feasible using hemostatic devices . For the hemostatic puncture closing device (HPCD), published data re garding sheath pulling in patients immediately after PTCA is limited, Furthermore, no study addressed the question whether the recommended d eployment time (DT) of 30 min can be reduced to a few minutes. We, the refore, performed a prospective study, randomizing 140 patients to a D T of 5 and 30 min, respectively. There were no statistical differences in gender, age, height, weight, or cardiovascular risk factors betwee n the two groups, Blood pressures measured invasively immediately befo re sheath removal were comparable. Activated coagulation time just pri or to sheath removal was 227 +/- 52 sec in the DT-5 group and 223 +/- 37 sec in the DT-30 group. After deployment, 74% of the DT-5 patients and 71% of the DT-30 patients showed immediate and complete hemostasis . The remaining patients showed only little oozing with complete hemos tasis at the time of the final device removal. Hematoma size after 24 hr was 6.2 +/- 4.4 cm(2) for DT-5 and 6.8 +/- 8.2 cm(2) for DT-30 pati ents, There was no statistical difference between both groups. No seve re bleeding or major complications were observed in either group, Thus , the use of a collagen system with an intra-arterial anchor (HPCD) is effective and safe when sheaths are pulled immediately after PTCA, Th e reduction of deployment time from 30 to 5 min is not related to an i ncreased risk of bleeding or other vascular complications; patients ca n be transferred much faster to the ward, therefore reducing the burde n on the personnel in the catheterization laboratory and increasing pa tients' comfort by allowing them to return to their rooms without a sh eath. (C) 1997 Wiley-Liss, Inc.