Comparison of HemCon Bandage with standard manual compression found HemCon resulted in faster hemostasis & fewer subcutaneous hematomas in heparinized sheep.

The study was published in the Journal of Cardiovascular and Interventional Radiology.

BACKGROUND

The purpose of this study was to evaluate the angiographic and histopathologic changes in the superficial femoral artery (SFA) in heparinized sheep shortly after catheterization with an 8-Fr sheath and manual compression hemostasis either with standard manual compression (SMC) or with the use of a procoagulant chitosan-based HemCon Bandage – now branded HemCon Patch.

METHODS

The evaluation was done in 38 SFAs of 19 heparinized (100 mg/kg) sheep. Nineteen sheep (16 female, 3 male) weighing from 45 to 70 kg were heparinized to an activated clotting time (ACT) >200 seconds. After a 5-min catheterization with an 8-Fr sheath, a 5-min compression was applied. For manual compression each sheep had a 2 x 2 inch HemCon Bandage applied on one SFA after sheath withdrawal, and the other SFA received standard manual compression (SMC). Follow-up angiograms to evaluate hemostasis were done immediately after release of compression and then at 2.5-min intervals until no extravasation was present. Compression was reapplied between angiograms. Final angiograms were performed approximately 30 min after hemostasis and after 3 min of passive flexion and extension of sheep hind limbs. Sheep were then euthanized and SFA specimens with surrounding tissues were excised for histopathologic evaluation.

RESULTS

The HemCon Bandage group achieved hemostasis 35% faster (mean, 6.18 ± 1.87 min) and with fewer subcutaneous hematomas (26.3%) than the SMC group (mean hemostatic time, 9.61 ± 3.35 min; 68.4% hematomas). Differences between both values were significant at p-values of 0.003 and 0.009, respectively. Otherwise there were no significant differences between groups regarding the other criteria evaluated.

Both types of compression caused similar changes in the catheterized SFAs. Follow-up angiograms showed mild arterial narrowing in 14 SFAs and intraluminal clots in 9 SFAs. Histology revealed periarterial hematoma in all 38 specimens. Intraluminal thrombi consisting predominantly of platelets and fibrin were present in 32 SFAs. Their size varied from superficial elevations (8 arteries) to medium-sized, 1- to 2-mm, polypoid protrusions (15 arteries) to large polypoid clots, 3-4 mm long (9 arteries).[/vc_column_text][vc_single_image image=”1114″ img_size=”full”][vc_column_text]CONCLUSIONS

Hemostasis with manual compression is achieved in the acute phase by formation of a predominantly platelet-fibrin thrombus occluding the arterial wall access site and often extending significantly into the arterial lumen. The healing process of arterial access sites should be explored several days after catheterization.

PUBLICATION DETAILS

Kim YH, Pavcnik D, Kakizawa H, Uchida BT, Burke A, Loriaux M, Keller FS, Rosch J.

Cardiovasc Intervent Radiol. 2010 Apr;33(2):321-9. doi: 10.1007/s00270-009-9688-2. Epub 2009 Aug 25.

Study Link: Thrombus formation after percutaneous catheterization and manual compression of the femoral artery in heparinized sheep

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