Sheath pulling immediately after PTCA: comparison of two different deployment techniques for the hemostatic puncture closure device: a prospective, randomized study.
Sheath pulling immediately after percutaneous transluminal coronary angioplasty (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 low risk of bleeding complications is feasible using hemostatic devices. For the hemostatic puncture closing device (HPCD), published data regarding sheath pulling in patients immediately after PTCA is limited. Furthermore, no study addressed the question whether the recommended deployment time (DT) of 30 min can be reduced to a few minutes. We, therefore, performed a prospective study, randomizing 140 patients to a DT of 5 and 30 min, respectively. There were no statistical differences in gender, age, height, weight, or cardiovascular risk factors between the two groups. Blood pressures measured invasively immediately before sheath removal were comparable. Activated coagulation time just prior 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 hemostasis at the time of the final device removal. Hematoma size after 24 hr was 6.2 +/- 4.4 cm2 for DT-5 and 6.8 +/- 8.2 cm2 for DT-30 patients. There was no statistical difference between both groups. No severe 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. The reduction of deployment time from 30 to 5 min is not related to an increased risk of bleeding or other vascular complications; patients can be transferred much faster to the ward, therefore reducing the burden on the personnel in the catheterization laboratory and increasing patients' comfort by allowing them to return to their rooms without a sheath.
Silber
S
S
Dr. Müller Hospital, Munich, Germany. ssilber@med.de
Dörr
R
R
Mühling
H
H
König
U
U
D000328:Adult; D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D005260:Female; D006470:Hemorrhage / Q000209:etiology / Q000503:physiopathology; D006488:Hemostasis, Surgical / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011182:Postoperative Care / Q000379:methods*; D011446:Prospective Studies; D016896:Treatment Outcome