Real evidence about coatings, cuffs & other measures to improve above knee synthetic graft patency: What is most effective in comparison with vein?
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1 Real evidence about coatings, cuffs & other measures to improve above knee synthetic graft patency: What is most effective in comparison with vein? Devaraj Srinivasamurthy ESVB 2013
2 Introduction Significant proportion of patients with severe PAD require surgical bypass BASIL trial : Bypass first strategy leads to significant increase in amputation free survival & overall survival TASC 11 : Surgical bypass preferred treatment option for C & D SFA lesions
3 Introduction Vein superior to Prosthetic grafts for infrainguinal bypass (Level 1 evidence) 5 yrs. Vein patency : 74 76% 5 yrs. Prosthetic patency : 39 52% Graft modifications, Surgical and Pharmacological adjuncts developed to improve Prosthetic patency
4
5 Aim An overview of the evidence behind adjuncts to improve prosthetic graft patency in Femoral to Above-Knee Popliteal bypass (AK-Pop bypass)
6 Evidence Graft materials Graft coatings Surgical adjuncts (cuffs) Emerging and experimental techniques
7 Graft Material Commonly used: Dacron and PTFE Dacron (Polyethylene terephthalate) : developed in 1941 by Whinfield and Dickinson from Great Britain PTFE (Polytetrafluorethylene) : developed by Dr Roy Plunkett in 1938
8 Dacron v/s PTFE N=228, Dacron : 114, PTFE :114 5 yrs. primary patency for Dacron: 52% v/s PTFE: 36%
9 Dacron v/s PTFE
10 Dacron v/s PTFE Author Number Conclusion Green et al (2000) 240 No difference in primary patency at 5 yrs Post et al (2001) 194 No difference in primary patency at 3 yrs
11 Dacron v/s PTFE
12 Graft coatings To reduce thrombogenicity Experimental evidence suggests heparin inhibits proliferation of vascular SMC s Heparin bonded Dacron grafts & Heparin bonded PTFE graft (Propaten)
13 Heparin bonded Dacron Devine et al (2001) : RCT comparing patency rates of Heparin-bonded Dacron v/ s PTFE N=209, 180 AK-Pop bypass, 3yrs follow-up Heparin-bonded Dacron grafts showed significantly better primary patency compared to PTFE up to 3 years
14 Heparin-bonded PTFE (Gore-Tex Propaten ) Scandinavian Propaten study RCT, n=555, Propaten v/s PTFE Inclusion: Fem-Fem cross over, Fem- Pop bypass Sub-group analysis of Fem-Pop (n=238) 1 yr Primary patency :81% for Propaten & 69% for PTFE (p 0.515)
15 Propaten : Prospective Non Randomised studies Author Number 1 yr Primary patency Hugl et al (2009) 142 (87 AK-Pop) 82.7% Bosiers et al (2006) 86 (55 AK-Pop) 84%
16 Propaten Retrospective studies Study/Author Number 1 yr Primary patency Italian Propaten Registry 425 (101 AK-Pop) 80 % Daenens et al 240 (84 AK-Pop) 92 %
17 Heparin Bonded Grafts Good short term patency Long term patency unknown Risk of Heparin Induced Thrombocytopenia Need for good quality RCT s
18 Surgical adjuncts: Cuffs Reduce neo-intimal hyperplasia at distal anastomosis Miller vein cuff most commonly used
19 Miller Cuff Stonebridge et al :multicentre RCT 261 infra-inguinal PTFE bypass with and without vein cuff (150 AK-Pop) No difference in patency for AK-Pop bypass at 2 years Griffiths et al: no difference in 5 yr patency with or without vein cuff
20 Emerging & Experimental techniques Endothelial seeding of prosthetic grafts Meinhart et al: 153 bypasses with seeded PTFE(102 AK-Pop) Primary patency for AK-Pop at 7yrs was 60% RCT compared patency rates with endothelial seeded PTFE grafts (66) v/s Vein (53) At 30 months, primary patency for seeded PTFE was 38% and 92% for Vein
21 Novel coatings Polypropelene Sulphide-Polyethylene Glycol (PEG), Hydrophilic acrylic polymers releasing salicylic acid, combined heparinthrombomodulin (anticoagulant), Hirudin, Iloprost, Plasminogen activator, Fibroblast growth factor, Cell binding peptide P15 and Nitric Oxide modifications Tested in animal experimental studies or in-vitro studies, shown to reduce graft thrombogenicity and neo-intimal hyperplasia
22 Conclusion Vein remains the gold standard for AK-Pop bypass Dacron has better long term primary patency compared to PTFE Vein cuff: No difference in long term patency Heparin-bonded grafts show good short-term patency
23 Thank you
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