Hemostatic efficacy of chitosan-based bandage for closure of percutaneous arterial access sites: An experimental study in heparinized sheep model
Background. Most of the presently used percutaneous arterial closure devices (PACD) for hemostasis after interventional vascular procedures are effective, but carry risk of complications by deposition of a foreign body. A new promising externally applied PACD - chitosan-based HemCon Bandage (HCB) was explored in sheep. The HCB hemostatic efficacy and complications occurring with its use were compared to those with the standard manual compression (SMC).
Material and methods. Both superficial femoral arteries (SFA) of 9 heparinized sheep were catheterized with an 8F sheath for 5 minutes. After the sheath withdrawal, hemostasis with the HCB was compared with hemostasis achieved with SMC in the contralateral SFA. Iliac angiograms performed by carotid artery approach determined the hemostasis time.
Results. The HCB use shortened time to hemostasis with a mean time of 6.9 ± 3.9 minutes versus 10.8 ± 2.8 minutes for the SMC (P-value 0.019). Seven SFAs in the HCB group and only 1 SFA in the SMC group exhibited hemostasis in 5 minutes. All nine SFAs using the HCB showed femoral artery patency and demonstrated less hematoma (2/9) than in the SMC group (8/9). No complications developed in the HCB group, one SFA occlusion was seen in the SMC group.
Conclusions. The externally applied HCB in heparinized sheep was safe and effective. It significantly shortened time to hemostasis at the SFA access sites following 8F sheath removal. Proper application of the HCB was necessary to shorten hemostasis and prevent hematoma formation. The HCB should be tested in a clinically controlled study to evaluate its efficacy in humans.
Seldinger SI. Catheter replacement of the needle in percutaneous arteriography; a new technique. Acta Radiol 1953; 39: 368-76.
Gjikolli B, Hadzihasanovic B, Jaganjac S, Herceglija E, Niksic M, Hadzimehmedagic A, et al. Treatment of complicated case with subclavia steal syndrome and stenosis of common iliac artery. Radiol Oncol 2008; 42: 1-12.
Hirsch JA, Reddy SA, Capasso WE, Linfante I. Non-invasive haemostatic closure devices. Tech Vasc Interv Radiol 2003; 6: 92-5.
Nguyen N, Hasan S, Caufield L, Ling FS, Marins CR. Radnomized control trial of topical hemostasis pad use for achieving vascular hemostasis following percutaneous coronary intervention. Catheter Cardiovasc Interv 2007; 69: 801-7.
Wang DS, Chu LF, Olson SE, Miller FJ, Valji K, Wong WH, et al. Comparative evaluation of noninvasive compression adjuncts for hemostasis in percutaneous arterial, venous and arteriovenous dialysis access procedures. J Vasc Interv Radiol 2008; 19: 72-9.
Mlekusch W, Dick P, Haumer M, Sabeti S, Minar E, Schillinger M. Arterial puncture site management after percutaneous transluminal procedures using a hemostatic wound dressing (Clo-Sur PAD) versus conventional manual compression: A randomized controlled trial. J Endovasc Ther 2006; 13: 23-31.
Hallak OK, Cubedder RJ; Griffith RA, Reyes BJ. The use of the D-STAT dry bandage for the control of vascular access site bleeding: A multicenter experience in 376 patients. Cardiovasc Intervent Radiol 2007; 30: 593-600.
Balzer JO, Schwarz W, Thalhammer A, Eichler K, Schmitz-Rixen T, Vogl TJ. Post interventional percutaneous closure of femoral artery access sites using the Clo-Sur PAD device: Initial findings. Eur Radiol 2007; 17: 693-700.
Rastan A, Sixt S, Swarzwalder U, Schwarz T, Frank U, Burgelin K, et al. VIPER-2: A prospective, randomized single-center comparison of 2 different closure devices with a hemostatic wound dressing for closure of femoral artery access sites. J Endovasc Ther 2008; 15: 83-90.
Applegate RJ, Sacrinty MT, Kutcher MA, Baki TT, Gandhi SK, Santos RM, et al. Propensity score analysis of vascular complications after diagnostic cardiac catheterization and percutaneous coronary intervention using thrombin hemostatic patch-facilitated manual compression. J Invasive Cardiol 2007; 19: 164-70.
Mlekusch W, Minar E, Dick P, Sabeti S, Bartok A, Haumer M, et al. Access site management after peripheral percutaneous transluminal procedures: Neptun Pad compared with conventional manual compression. Radiology 2008; 249: 1058-63.