In:
Journal of Endovascular Therapy, SAGE Publications, Vol. 23, No. 5 ( 2016-10), p. 744-750
Abstract:
Purpose: To present the results of a prospective single-center study that evaluated the safety and efficacy of a hemostatic dressing following femoral artery access. Methods: Within a 9-month period, 80 patients (mean age 68±14 years; 55 men) were treated with a hemostatic dressing patch (Hematrix Active Patch) containing aminocaproic acid, calcium chloride, and thrombin after endovascular procedures via a 6- to 8-F femoral artery access. After removing the sheath, the wound dressing was placed on the puncture site followed by constant manual compression adapted to the sheath size (specified pressure times: 8 minutes for 6-F, 9 minutes for 7-F, and 10 minutes for 8-F). Patients were treated with an additional pressure bandage for 24 hours. Hemostasis was checked clinically and with duplex ultrasound after patch removal and at 24 hours. Patient characteristics [platelets, systolic blood pressure, international normalized ratio (INR), and partial thromboplastin time (PTT)], sheath sizes, and approach direction were compared among patients with successful hemostasis (within specified pressure times) vs those with prolonged compression. Results: A total of 39 6-F, 19 7-F, and 22 8-F sheaths were employed. In 73 (91.2%) of 80 patients, hemostasis was reached within the prespecified pressure times (mean 8.8±0.8 minutes). In 7 patients (4 6-F, 1 7-F, 2 8-F) a longer compression time was necessary (mean 34±30 minutes). No serious major complication occurred. Twelve (15.0%) minor and 5 (6.3%) moderate subcutaneous hematomas were observed. Two (2.5%) false aneurysms were treated successfully. Ambulation and discharge was possible within 24 hours in 79 (98.7%) cases. Patients with initial hemostasis and those with prolonged compression did not differ substantially (p 〉 0.05) according to sheath size, approach direction, INR (1.09±0.3 vs 1.11±0.3), platelets (234±47×10 3 /µL vs 249±93×10 3 /µL), systolic blood pressure (150±26 vs 152±17 mm Hg), or PTT (31±7.9 vs 34.8±10.0 seconds). Conclusion: The evaluated wound dressing seems to be safe and effective in reducing time to hemostasis in large arterial access sites. However, a randomized trial with a larger population and an active control group is necessary to confirm these preliminary data. Moreover, additional focus on shortening the time to ambulation is required in future studies.
Type of Medium:
Online Resource
ISSN:
1526-6028
,
1545-1550
DOI:
10.1177/1526602816658029
Language:
English
Publisher:
SAGE Publications
Publication Date:
2016
detail.hit.zdb_id:
2006618-1
detail.hit.zdb_id:
2049858-5
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