Heparin coating

Discontinue all heparin and low molecular weight heparin sources o Intravenous, subcutaneous, flushes, and heparin-coated catheters... 

Collect blood in sterile heparin coated vacutainers. 

Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product and which is liable to act upon the body with action ancillary to that of the device (e.g. a heparin-coated catheter), the product is classed as a medical device. However, the medicinal product is to be assessed in accordance with the requirements of Directive 75/318/EEC (replaced by 2001/83/EC and updated by 2003/63/EC). A notified body undertaking conformity assessment on a medical device which incorporates a medicinal substance having ancillary action has a responsibility to consult a national medicines agency about the medicinal substance, to verify its safety, quality and usefulness by analogy with the appropriate methods specified in Directive 75/318/EEC. 

Special rules 13-18 govern several hazardous characteristics that may be found in certain devices and require a certain level of control and conformity assessment. Rule 13 deals with devices incorporating a medicinal substance whose action is ancillary to that of the device -Class 111, for example, antibiotic bone cements, condoms with spermicides, heparin-coated catheters. 

A more recent study of 18 infants on ECMO life support also reported leaching of di(2-ethylhexyl) phthalate from the PVC circuits at linear rates that were dependent on the surface area of the circuit. For standard 3-10-day treatment courses, the mean peak plasma concentration of di(2-ethylhexyl) phthalate was 8.3 5.7 mg/L, and the estimated exposure over 3-10 days was 10-35 mg/kg bw. No leaching of di(2-ethylhexyl) phthalate from heparin-coated PVC circuits was detected (Karle et al., 1997). 

Hardhammar, P.A., van Beusekom, H.M., Emanuelsson, H.U., Elofma, S.E1., Albertsson, P.A., Verdouw, P.D. et al. (1996) Reduction in thrombotic events with heparin-coated Palmaz-Schatz stents in normal porcine coronary arteries. Circulation, 93, 423 130. 

Serruys, P.W., Emanuelsson, H., van der Giessen, W., Lunn, A.C., Kiemeney, F., Macaya, C. et al. (1996) Heparin-coated Palmaz-Schatz stents in human coronary arteries. Early outcome of the Benestent-II Pilot Study. Circulation, 93, 412—422. 

Optimal stent implantation and new antiplatelet therapy have reduced the thrombotic complication after stent implantation, dramatically. However, thrombosis remains a challenge in some lesions and patient subgroups. As an initial and unavoidable event during stent implantation, thrombosis and platelet activation are also involved in the development of neointimal hyperplasia. Stents coated with heparin and other antithrombotic drugs have been demonstrated to decrease thrombotic complications, although their effect on neointimal hyperplasia remains uncertain. As heparin is attached to the stent surface, we divide thromboresistant stents as heparin-coated stents and drug-eluting thromboresistant stents. 

Heparin-coated Palmaz-Schatz, Wiktor, Jostent, BX Velocity, and beStent have been investigated in clinical studies. All studies showed that heparin-coated stents are safe, even in high-risk lesions. When compared with balloon angioplasty, heparin-coated stents could significantly reduce the rate of subacute stent thrombosis and the late restenosis. However, no significant difference of restenosis was observed between the heparin-coated stent and the bare stent control. 

Hardhammar P Van Beusekom H, Emanuelsson H, et al. Reduction in thrombotic events with heparin-coated Palmaz-Schatz stents in normal coronary arteries. Circulation 1996 93 423-430. 

Lin PH, Chronos NA, Marijianowski MM, et al. Carotid stenting using heparin-coated balloon-expandable stent reduces intimal hyperplasia in a baboon model. J Surg Res 2003 I 12( I ) 84-90. 

Kocsis JF Lunn AC, Mohammad SR Incomplete expansion of coronary stents risk of thrombogenesis and protection provided by a heparin coating [abstr]. J Am Coll Cardiol 1996 27(suppl A) 84A. 

Blezer R, Cahalan I, Cahalan PT et al. Heparin coating oftanta-lum coronary stents reduces surface thrombin generation but not factor Ixa generation. Blood Coagul Fibrinolysis 1998 9(5) 435-440. 

Christensen K, Larsson A, Emanuelsson H, et al. The stent graft modulation of platelet and coagulation activation with heparin coating [abstr], Eur Heart J 1998 19 (suppl) 498. 

Beythien C, Gutensohn K, Bau J, et al. Influence of stent length and heparin coating on platelet activation a flow cytometric analysis in a pulsed floating model. Thromb Res 1999 94(2) 79-86. 

Bickel C, Rupprecht HJ, Darius H, et al. Substantial reduction of platelet adhesion by heparin-coated stents. J Interv Cardiol 2001 14(4) 407-413. 

Zidar I, Jackman J, Gmmon R, et al. Serial assessment of heparin coating on vascular response to a new tantalum stent [abstr]. Circulation 1992 89 1-185,... 

Zidar I, Virmani R, Culp S, et al. Quantitative histopathologic analysis of the vascular response to heparin coating of the Cordis stent [abstr], J Am Coll Cardiol 1993 I2 336A,... 

Baily SR, Paige S, Lunn A, et al. Heparin coating of endovascular stents decreases subacute thrombosis in a rabbit model, Circulation I 992 86(suppl) l I 86. 

Stratienko A, Zhu D, Lambert C, et al. Improved thrombore-sistance of heparin coated Palmaz-Schatz coronary stents in an animal model [abstr]. Circulation 1993 88 1-596,... 

Sheth S, Dev V Jacobs H, et al. Prevention of subacute stent thrombosis by polymer-polyethylene oxide-heparin coating in rabbit carotid artery [abstr]. J Am Coll Cardiol 1995 25 348A. 

De Scheerder I, Wang K, Wilczek K, et al. Experimental study of thrombogenicity and foreign body reaction induced by heparin-coated coronary stents. Circulation 1997 95 1549-1553. 

Schurmann K, Vorwerk D, Uppenkamp R, et al. Iliac arteries plain and heparin-coated Dacron-covered stent-grafts compared with noncovered metal stents-an experimental study. Radiology 1997 203(l) 55-63. 

Ahn YK, Jeong MH, Kim JW, et al. Preventive effects of the heparin-coated stent on restenosis in the porcine model. Catheter Cardiovasc Interv I 999 48(3) 324-330. 

Vrolix M, Grollier G, Legrand V et al. Heparin-coated wire coil (Wiktor) for elective stent placement-The MENTOR trial (abstract), Eur Heart J 1997 18 155. 

Wohrle J, Grotzinger U, Al-Kayer I, et al. Comparison of the heparin-coated and the uncoated version of the JOMED stent with regards to stent thrombosis and restenosis rates [abstr], Eur Heart J I 999 20(suppl) 27l. 

Vrolix M, Legrand V Reiber JH, et al. Heparin-coated wiktor stents in human coronary arteries. Am J Cardiol 2000 86(4) 3 85-3 89. 

Degertekin M, Gencbay M, Sonmez K, et al. Comparison of heparin-coated jomed stents with uncoated stents in patients with coronary artery disease. 3rd International Congress on Coronary Artery Disease, Lyon, France, Oct 2-5, 2000 128,... 

Kedev S, Guagliumi G, Valsechi O, Tespili M. Heparin-coated versus uncoated Palmaz-Schatz stent in native coronary circulation. A randomized study with blind angioscopic assessment. Int J Artif Organs 2002 25(5) 461 -469. 

Semiz E, Ermis C, Yalcinkaya S, et al. Comparison of initial efficacy and long-term follow-up of heparin-coated Jostent with conventional NIR stent. Jpn Heart J 2003 44(6) 889-898. 

Gurbel PA, Bliden KP Platelet activation after stenting with heparin-coated versus noncoated stents. Am Heart J 2003 ... 

Mehran R, Aymong ED, Ashby DT et al. Safety of an aspirin-alone regimen after intracoronary stenting with a heparin-coated stent final results of the HOPE (HEPACOAT and an Antithrombotic Regimen of Aspirin Alone) study. Circulation 2003 108(9) 1078-1083. 

Haude M, Konorza Tp Kalnins U, et al. Heparin-coated stent placement for the treatment of stenoses in small coronary arteries of symptomatic patients. Circulation 2003 ... 

Jaster M, Schwimmbeck P Spencker S, et al. Randomized comparison of platelet-leukocyte aggregates and platelet activation in blood heparin-coated coiled wire stent implantation versus balloon angioplasty in acute myocardial infarction, Thromb Res 2003 I 12(5-6) 285-289,... 

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