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Ringband V 17072014 Definitief Periprocedural prophylactic antithrombotics in arterial procedures: The road to consensus… Periprocedurele profylactische antitrombotica in arteriële procedures: De weg naar consensus… (met een samenvatting in het Nederlands) Arno Mac Wiersema 1 ISBN 978-90-393-6136-8 App: Uitleg-video: http://vimeo.com/101308261 App design: Harm Ebben @ http://www.thesisapps.com Uitleg-video design: Kees Post & Matthijs Panhuis @ http://www.emations.nl Design of thesis: Kees Post @ www.keespost.nl Printing: GVO/Ponsen & Looijen @ www.proefschriften.nl Cover image: Painting of Zomer en Puck (daughters of author and his wife) on the beach of Los Angeles, on their road to consensus Painter: Paul Bruijninckx@ http://www.haagsekunstenaars.nl/cv/33330/Paul+Robbert+Bruijninckx Photography: Dr. Jeroen de Haan Financial support for research in this thesis was obtained by kind contributions from: Dr. G.J. van Hoytema Stichting W.L. Gore & Associates BV, Scovas Medical BV Excen BV: Wond Expertise Centra Nederland BV, Westfriesgasthuis Cook Medical, Medtronic NL BV, Angiodynamics, Lohmann & Rauscher Nederland BV, Lamepro BV Vascutek Nederland, Cordis-Johnson & Johnson BV, Angiocare BV, Chipsoft BV, Urgo Medical, Macquet Netherlands BV, Biotronik Nederland BV, B. Braun Medical BV, Spring Medical 2 Periprocedural prophylactic antithrombotics in arterial procedures: The road to consensus… Periprocedurele profylactische antitrombotica in arteriële procedures: De weg naar consensus… (met een samenvatting in het Nederlands) Proefschrift ter verkrijging van de graad van doctor aan de universiteit Utrecht op gezag van de rector magnificus, prof. dr. G.J. van der Zwaan, ingevolge het besluit van het college voor promoties in het openbaar te verdedigen op donderdag 4 september 2014 des middags te 2.30 uur door Arno Mac Wiersema geboren op 17 juli 1964 te Amsterdam 3 Promotor: Prof. dr. F.L. Moll Copromotoren: Dr. C.M.A. Bruijninckx Dr. J.A. Vos Financial support by the Dutch Heart Foundation for the publication of this thesis is gratefully acknowledged. 4 Aan mijn vader Hans (†): “Jongen, je kent het en je kunt het” 5 Contents Chapter 1 General introduction 9 Chapter 2 The history of heparin: Part I: The discovery: An intriguing story, tainted by intrigue 17 Submitted. Part II: The early development and road to clinical use. 43 Chapter 3 Perioperative prophylactic antithrombotic strategies in vascular 81 surgery: current practice in the Netherlands. Journal Cardiovascular Surgery (Torino) 2013 Jan 22. [Epub ahead of print]. Chapter 4 Periprocedural prophylactic antithrombotic strategies in 103 interventional radiology: current practice in the Netherlands and comparison with the United Kingdom. CardioVascular Interventional Radiology 2013; 36:1477-92. Chapter 5 Prophylactic perioperative anti-thrombotics in open and 129 endovascular abdominal aortic aneurysm (AAA) surgery: a systematic review. European Journal of Vascular and Endovascular Surgery 2012; 44:359-67. Chapter 6 Prophylactic intraoperative antithrombotics in open infrainguinal 157 arterial bypass surgery (IABS): a systematic review. Journal Cardiovascular Surgery (Torino) 2014 Mar 4. [Epub ahead of print]. 6 Chapter 7 Heparin in interventional radiology: a synopsis. 187 Submitted. Chapter 8 The DREAM of using heparin during open AAA repair. 201 Submitted after revisions. Chapter 9 No Antithrombotics Needed During open abdominal Aneurysm 217 repair? (NANDA?) Manuscript in preparation. Chapter 10 Letters to Editor 249 Chapter 11 Summary, general discussion and the road ahead … 259 Chapter 12 Samenvatting in het Nederlands 273 Dankwoord 287 Curriculum vitae 293 7 8 Chapter 1 General introduction 9 General introduction In 1940 Murray1 published his paper on the role of “heparin in surgical treatment of blood vessels”. The introduction of heparin as a periprocedural prophylactic antithrombotic (PPAT) in vascular surgery, caused an increase in the development of surgical interventions in the arterial circulation by enhancing the technical possibilities and increasing the results of those interventions.2 Heparin was soon implemented in daily practice by vascular surgeons around the world. Heparin reduces the clotting of blood while clamping arteries and thereby reduces thrombotic complications while performing arterial reconstructions.2 This permitted the pioneers of vascular surgery to expand the possibilities of operations on the arterial and venous blood vessels.3 After those early days of vascular surgery it became even possible to extend the scope of surgery to the heart. The invention and introduction of the heart-lung machine in cardiac surgery in 1953,4 was merely possible by the grace of a strong and efficacious anti-thrombotic: heparin. After Charles Dotter published on the first percutaneous transluminal angioplasty (PTA) in 1964,5 this form of endovascular interventions in the arterial circulation rapidly developed, and became standard of care in the treatment of arterial disease.6,7 Heparin started being administered during all of these (percutaneous) endovascular interventions without many (randomized) trials, mainly because it appeared to be successful during open procedures and percutaneous coronary interventions. Soon wires and catheters became coated with heparin to further reduce the thrombogenicity of endovascular arterial interventions.8,9 The advantage of using heparin in vascular surgery and interventional radiology, is self- evident as it prevents blood from clotting. However it became soon apparent that this use of heparin also has a major clinical disadvantage: the prolonged clotting of blood causes an increase in bleeding complications. The prolonged coagulation by heparin increases peri- and post-procedural bleeding. This can lead to (life-threatening) acute blood loss and the need for blood transfusions. The negative side effects of blood transfusion are nowadays widely recognized.10 Blood transfusion may cause a serious allergic reaction and can cause, despite extensive matching, the formation of antibodies. Also transfusions can lead to the transmission of viral, bacterial and parasitological infectious diseases. Finally, blood transfusion suppresses the immune 10 system and can influence the coagulation cascade. More periprocedural blood loss increases procedure time, possibly leading to more (infectious) complications. Additionally, the incidence and severity of post-procedural hematoma at site of operation or puncture may cause other complications, such as pain and infection. Hematoma thereby increases the incidence of wound infection, a serious complication, which leads to more re-interventions and even a higher mortality for patients undergoing open or endovascular arterial interventions.11,12 The use of heparin can also lead to the development of heparin induced thrombocytopenia (HIT) syndrome.13 This is an unpredictable response of the immune system on the administration of heparin. It can occur even after only a single bolus dose of heparin. HIT can lead to clinically relevant arterial and venous thrombo-embolic complications, which can lead to amputation and in its most severe form even to death. The incidence of HIT varies in literature from 0.5 to 5%.13 Another major disadvantage of the use of heparin as a periprocedural prophylactic antithrombotic is the fact that heparin has no linear dose-response curve and no linear elimination curve in vascular patients.14-16 Heparin is a glycosaminoglycan and influences the coagulation cascade mainly through an interaction with antithrombin III (AT-III). Heparin also interacts with heparin cofactor II and directly with factor Xa. Heparin forms a biochemical complex with AT-III and this combination of enzyme and inhibitor inactivates coagulation enzymes including thrombin (IIa), but also factor IXa, Xa, XIa and XIIa. Heparin influences coagulation mostly by interaction with thrombin (IIa), the most sensitive to inhibition by heparin/AT-III.17-19 11 Heparin is heterogeneous in its size and weight of molecules, its effect on coagulation and its pharmacokinetic effects. These facts explain why heparin has a non-linear effect on coagulation: on average approximately 33% of heparin molecules exert AT-III mediated anticoagulant activity; heparin molecules with a chain-length of less than 18 saccharides have no influence on AT-III/antithrombin and the higher molecular weight molecules of heparin are subject to a faster biological clearance from the blood. These molecules however, exhibit low activity on AT-III and are therefore of less clinical influence on coagulation. Furthermore heparin binds non-specifically to proteins and cells in the blood of the patient. This causes a further limiting of the clinical effect of heparin administration. This non-specific binding causes low bioavailability at low doses of heparin, also a short plasma half-life time and creates a large variability in anticoagulant effect among patients with vascular disease.17-19 Since 1972, it is also known from literature, that differences in the potency of heparin exists between heparin brands.20,21 This increases the non-predictable response in the vascular patient undergoing arterial interventions. Heparin is not absorbed through the gastro-intestinal mucosa and is preferentially administered intravenously. Subcutaneous injection is also possible, but it takes longer for heparin to reach therapeutic levels and the doses of heparin should be 10% higher to equal the bioavailability reached by the intravenous route.17-19 To measure the clinical effect of the
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