VASCULAR SURGERY UNIT FERRAROTTO Hospital Catania - Italy Below knee bypass with heparin bonded graft: More than 10 years of practical experience Dr. S. A. Turiano Magyar Angiológiai és Érsebészeti Társaság Szombathely June 15 - 17, 2017.
VASCULAR SURGERY UNITFERRAROTTO Hospital
Catania - Italy
Below knee bypass with heparin bonded graft:
More than 10 years of practical experience
Dr. S. A. Turiano
Magyar Angiológiai és Érsebészeti Társaság
Szombathely June 15-17, 2017.
Greater Saphenous Vein
Gold Standard
20% - 40% of cases Saphenous Vein is not available
Previous surgery ( CABG or other )
Not usable ( poor quality )
Obesity ( ▲morbidity )
CHOICE OF CONDUITTreatment protocol
ASV in high risk patients Diabetes
CHF
Poor plantar run off
Single below knee vessel
Thrombophilia
CLI with ulceration or gangrene of foot or toes
Propaten® in all low risk patients
CHOICE OF CONDUITTreatment protocol
Step I Endovascular
Step IIPropaten Bypass
Step III ASV Bypass
Early interventionto delay bypass and to improve in and out flow
In selected cases• Target vessels
popliteal artery or TP trunk
• Two or more distalvessels
• Good plantarcirculation
• No thrombophilia
One distal vesselPoor runoff
CHOICE OF CONDUITliterature review
Overall weighted Average Primary Patency
Total cases 494 1 year 2 years 3 years
BK fem-pop 264 83% 81% 75%
BK infrapopliteal 199 79% 69% 60%
Puttaswami et al 2005 Wallusheck et al 2005 Dorigo et al 2005
CHOICE OF CONDUITliterature review
“The greater saphenous vein performs betterthan polytetrafluoroethylene in femoropopliteal bypass grafting and shouldbe used whenever possible.
However, the absence of a suitable saphenousvein remains an acceptable indication for a femoral popliteal bypass in PTFE.”
Pereira et al., Meta-analysis of femoropopliteal bypass grafts for lowerextremity arterial insufficiency J Vasc Surg 2006; 44:510-7
Preliminary considerations
Italian Propaten Registry
In order to evaluate early and long term results
of the use of a heparin-bonded ePTFE graft in
patients undergoing surgical treatment for PAD.
Participating centres
Propaten Score
Gender Male 1 point Female 2 points --
Redo surgery No 1 point Yes 2 points --
Tibial anastomosis No 1 point Yes 2 points --
Run off Two vessels 2 points One vessel 3 points --
Rutherford class Class IV 1 point Class V 2 points Class VI 3 points
ANOVA test for thrombosis found 7.502 as the cut-off score value (p<0.001; R=0.09).
Materials and Methods
Total 615 patients
300 selected cases treated with Propaten®
255 male, mean age 70,2 yrs,
mean follow up 42 months (1-161)
Risk factors
Diabetes 42,7 %
Smoke 75,0 %
HTN 83,0 %
CRI 18,3 %
Materials and Methods
238 patients underwent primary treatment
62 patients had bypass following a previous
open treatment
274 patients had more than one distal artery
Target arteries
popliteal (219)
tibio peroneal trunk (68)
posterior tibial (9)
anterior tibial (2)
peroneal (2)
ResultsHospital complications
Early graft thrombosis (8 cases – 2.7%)
A.K. amputation (5 cases – 1.7%)
Wound dehiscence (2 cases – 0.7%)
Myocardial infarction (2 cases – 0.7%)
Mortality rate 0.3% (one case)
Results
0
20
40
60
80
100
PRIMARY PATENCY LIMB SALVAGE AMPUTATION FREE SURVIVAL
HOW TO MANAGE TO BYPASS INFRA POPLITEAL VESSELSIN PATIENTS WITH INSUFFICIENT VEIN LENGTH ?
COMPOSITE BYPASS GRAFT
OBJECTIVE OF COMPOSITE GRAFT
UNIFORMITY OF DIAMETER AT ANASTOMOSIS SITE
OBJECTIVE OF COMPOSITE GRAFT
UNIFORMITY OF DIAMETER AT ANASTOMOSIS SITE
Tips & Tricks
Short graft bevelled ends leadto angled junction and turbulences
Tips & Tricks
Tips & Tricks
Average vein length 12 cms (10- 30 cms)
MATERIALS & METHODSfrom June 2004 to September 2016
Composite group49 pts
ASV group242 pts
72 ( 47 / 87) mean age 73 ( 38 / 92 )
75,11% male / female ratio 75%
51,87% diabetes 45%
92,32% hypertension 95%
81,08% hyperlipemia 75%
64,5% smoke 62,5%
19,01% renal insufficiency 22,5%
CAD 33,53% 0,27 ABI 0,25
No significant differences between groups
MATERIALS & METHODS
Composite group
49 patients
Target Arteries
Posterior Tibial 17
Anterior Tibial 15
Peroneal 11
Tibioperoneal trunk 6
30 DAY OUTCOME
MORTALITY 0 ( 3 ) 1,2%GRAFT THROMBOSIS ( 3 ) 6,1% ( 7 ) 2,8%A.K. AMPUTATION ( 1 ) 2,0% ( 6 ) 2,4%
25
Composite group49 pts
ASV group242 pts
No significant differences between groups
LATE OUTCOME
MORTALITY ( 3 ) 6,12% ( 10 ) 4,13%
GRAFT THROMBOSIS ( 14 ) 35,0% ( 44 ) 26,0%
A.K. AMPUTATION ( 5 ) 12,5% ( 17 ) 10,1%
26
Composite group49 pts
ASV group242 pts
MEAN FOLLOW UP 24 months 27,7 months
No significant differences between groups
RESULTSPRIMARY PATENCY
P < 0,02
RESULTSLIMB SALVAGE
78
87
60
70
80
90
100
0 1 2 3 4 5 6 7 8 9
AT PT Peroneal COMPOSITE
83
Conclusions I
Data from our retrospective study confirmed that the indexed heparin-bonded ePTFE graft provides
satisfactory early and midterm results in patients undergoing surgical treatment for critical limb ischemia.
Primary patency, limb salvage, amputation-free survival rates make this graft an excellent alternative to autologous saphenous vein not only when it is absent or
unsuitable as conduit, but also when vein should be spared for successive bypass.
Conclusions II
Greater saphenous vein is the gold standard
conduit when targeting the infrapopliteal vessels
but the composite e-ptfe graft with vein at distal end
is “an excellent alternative in those patients
with complex multi segmental occlusions and
in whom satisfactory saphenous vein for direct
revascularization is not available”
Conclusions II
Primary patency, limb salvage, amputation-free survival rates make this graft an excellent alternative to autologous
saphenous vein not only when it is absent or unsuitable as conduit, but also when vein
should be spared for successive bypass.
Products listed may not be available in all markets.
GORE, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
GORE® PROPATEN® Vascular Graft
• Heparin molecules are bound directly to the luminal surface of the graft
– Heparin is a polysaccharide anticoagulant with a long history of clinical use1
– Heparin has a potent antiproliferative effect on vascular smooth muscle cells2
• A proprietary end-point attachment mechanism, the CARMEDA®
BioActive Surface (CBAS® Surface), is utilized to bind heparin molecules to the graft surface
1 Hirsh J, Anand SS, Halperin JL, Fuster V; American Heart Association. Guide to anticoagulant therapy: Heparin : a statement for
healthcare professionals from the American Heart Association. Circulation 2001;103(24):2994-3018.
2 Clowes AW, Karnowsky MJ. Suppression by heparin of smooth muscle cell proliferation in injured arteries.
Nature 1977;265(5595):625-626.
GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 – 2012 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
CARMEDA® and CBAS® are trademarks of Carmeda AB, a wholly owned subsidiary of W. L. Gore & Associates, Inc.
Products listed may not be available in all markets.
GORE, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
CBAS® Surface:
Proprietary End-Point Covalent Bonding
Bioactive site Heparin
molecule
End-point
covalent bondGraft surface
GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 – 2012 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
CARMEDA® and CBAS® are trademarks of Carmeda AB, a wholly owned subsidiary of W. L. Gore & Associates, Inc..
Products listed may not be available in all markets.
GORE, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
Heparin: Mechanism of Action
• Thrombin converts soluble fibrinogen into insoluble strands of fibrin
• Heparin catalyzes (up to 1,000 fold) inactivation of thrombin by
Antithrombin III
Björk I, Lindahl U. Mechanism of the anticoagulant action of heparin. Molecular & Cellular Biochemistry 1982;48(3):161-182.
Fibrinogen (soluble) Fibrin (insoluble)
Thrombin
GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 – 2012 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
Products listed may not be available in all markets.
GORE, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
CBAS® Surface Mechanism of Action
Bioactive site of the heparin molecule enables
antithrombin to bind thrombin.
AT : Antithrombin
T : Thrombin
AT
T
GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 – 2012 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
CARMEDA® and CBAS® are trademarks of Carmeda AB, a wholly owned subsidiary of W. L. Gore & Associates, Inc.
Products listed may not be available in all markets.
GORE, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
CBAS® Surface Mechanism of Action
AT-T : Antithrombin-thrombin
neutral complex
When anti-thrombin binds to thrombin,
a neutral AT-T complex is formed.
AT-T
GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 – 2012 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
CARMEDA® and CBAS® are trademarks of Carmeda AB, a wholly owned subsidiary of W. L. Gore & Associates, Inc.
Products listed may not be available in all markets.
GORE, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
CBAS® Surface Mechanism of Action
AT-T : Antithrombin-thrombin
neutral complex
Neutral AT-T complex detaches from the heparin molecule.
Active site becomes available to again bind antithrombin.
AT-T
GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 – 2012 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
CARMEDA® and CBAS® are trademarks of Carmeda AB, a wholly owned subsidiary of W. L. Gore & Associates, Inc.
Products listed may not be available in all markets.
GORE, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
Reduced Fibrin Formation —
Human Ex-Vivo Model
Heyligers JMM, Lisman T, Weeterings C, et al. Heparin immobilization reduces thrombogenicity on small-caliber
ePTFE grafts. Journal of Vascular Surgery 2006;43(3):587-591.
GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 – 2012 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
Products listed may not be available in all markets.
GORE, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
How Long Does Heparin Last? (Canines)
• In-vivo canine
aorto-iliac bypasses
• 15 GORE® PROPATEN®
Vascular Grafts and five
control ePTFE
(6 mm x 12 cm)
Begovac PC, Thomson RC, Fisher JL, Hughson A, Gällhagen A. Improvements in GORE-TEX® Vascular Graft performance by Carmeda®
bioactive surface heparin immobilization. European Journal of Vascular & Endovascular Surgery 2003;25(5):432-437.
GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 – 2012 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
CARMEDA® and CBAS® are trademarks of Carmeda AB, a wholly owned subsidiary of W. L. Gore & Associates, Inc.
Products listed may not be available in all markets.
GORE, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
How Long Does Heparin Last?
(Human Explant)
• Explant after 239 days
(~ 8 months)
– Femoral to anterior tibial bypass
• Heparin bioactivity detected
– Above the level required for
thromboresistance in a challenging
blood contact model
GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 – 2012 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
Products listed may not be available in all markets.
GORE, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
How Long Does Heparin Last?
(Human Explant)
• Explant after 1111 days
(> 3 years)
– Below-knee femoral to
tibioperoneal trunk bypass
– Outflow vessel
(peroneal) occluded
• Heparin bioactivity detected
– Above the level required for
thromboresistance in a challenging
blood contact model
GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 – 2012 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
Products listed may not be available in all markets.
GORE, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
• Explant after 1,553 days
(> 4 years)
– Femoropopliteal bypass
• Heparin bioactivity detected
– Above the level required for
thromboresistance in a challenging
blood contact model
How Long Does Heparin Last?
(Human Explant)
GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 – 2012 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
Products listed may not be available in all markets.
GORE, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
• Explant after 2,939 days
(8 years)
– Femoral to posterior tibial bypass
with polyester Linton patch
– Distal anastomosis occluded
• Heparin bioactivity detected
– Above the level required for
thromboresistance in a challenging
blood contact model
How Long Does Heparin Last?
(Human Explant)
GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 – 2012 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
Products listed may not be available in all markets.
GORE, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
Acute Thromboresistance — Canines
• A stringent animal thrombotic model
• In-vivo canine carotid artery interposition model
• 3 mm GORE® PROPATEN® Vascular Graft vs. control ePTFE;
acute two hour experiment
Begovac PC, Thomson RC, Fisher JL, Hughson A, Gällhagen A. Improvements in GORE-TEX® Vascular Graft performance by
Carmeda® bioactive surface heparin immobilization. European Journal of Vascular & Endovascular Surgery 2003;25(5):432-437.
GORE® PROPATEN®
Vascular Graft
Control ePTFEControl ePTFE
GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 – 2012 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
Products listed may not be available in all markets.
GORE, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
Platelet Deposition — Baboons
Lin PH, Chen C, Bush RL, Yao Q, Lumsden AB, Hanson SR. Small-caliber heparin-coated ePTFE grafts reduce platelet deposition and
neointimal hyperplasia in a baboon model. Journal of Vascular Surgery 2004;39(6):1322-1328.
GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 – 2012 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
Products listed may not be available in all markets.
GORE, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
Neointimal Hyperplasia Reduction — Canines
Lin PH, Bush RL, Yao Q, Lumsden AB, Chen C. Evaluation of platelet deposition and neointimal hyperplasia of heparin-coated
small-caliber ePTFE grafts in a canine femoral artery bypass model. Journal of Surgical Research 2004;118(1):45-52.
Neointimal hyperplasia at the distal anastomosis A) Control ePTFE;
B) GORE® PROPATEN® Vascular Graft
Canine femoro-femoral artery bypass grafting model.
GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 – 2012 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
Products listed may not be available in all markets.
GORE, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
Neointimal Hyperplasia Reduction — Baboons
Lin PH, Chen C, Bush RL, Yao Q, Lumsden AB, Hanson SR. Small-caliber heparin-coated ePTFE grafts reduce platelet deposition and
neointimal hyperplasia in a baboon model. Journal of Vascular Surgery 2004;39(6):1322-1328.
Neointimal hyperplasia at the distal anastomosis A) Control ePTFE;
B) GORE® PROPATEN® Vascular Graft
Baboon aortoiliac bypass grafting model
GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 – 2012 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
Products listed may not be available in all markets.
GORE, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
Improved Patency and
Reduced Intimal Hyperplasia — Sheep
• Standard ePTFE versus GORE® PROPATEN® Vascular Graft
(6 mm diameter, 6 cm length)
• 28 common carotid arteries in 14 sheep (first large animal study)
• Explantation after six months
• IH thickness measured
• Six month patency rates
– 86% for GORE® PROPATEN® Vascular Graft
– 36% for standard ePTFE
GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 – 2012 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
Products listed may not be available in all markets.
GORE, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 - 2010 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
Reduced Intimal Hyperplasia - Sheep
A) Standard PTFE (mean = 0.259 mm):
Turquoise: intimal hyperplasia
Yellow: graft material
B) CBAS® Surface-PTFE graft (mean = 0.074mm):
Turquoise: thin layer of intimal hyperplasia
Yellow: graft material
Mean IH thickness statistically significantly
different across all anastomoses
GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2008 – 2012 W. L. Gore & Associates, Inc. AK0802-EN3 MARCH 2012
CARMEDA® and CBAS® are trademarks of Carmeda AB, a wholly owned subsidiary of W. L. Gore & Associates, Inc.