Below knee bypass with heparin bonded graft: More than 10...

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

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

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

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%

ASV group242 pts

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%

ASV group242 pts

MEAN FOLLOW UP 24 months 27,7 months

RESULTSPRIMARY PATENCY

P < 0,02

RESULTSLIMB SALVAGE

0 1 2 3 4 5 6 7 8 9

AT PT Peroneal COMPOSITE

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.

CARMEDA® and CBAS® are trademarks of Carmeda AB, a wholly owned subsidiary of W. L. Gore & Associates, Inc.

CBAS® Surface:

Proprietary End-Point Covalent Bonding

Bioactive site Heparin

molecule

End-point

covalent bondGraft surface

CARMEDA® and CBAS® are trademarks of Carmeda AB, a wholly owned subsidiary of W. L. Gore & Associates, Inc..

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

CBAS® Surface Mechanism of Action

Bioactive site of the heparin molecule enables

antithrombin to bind thrombin.

AT : Antithrombin

T : Thrombin

AT-T : Antithrombin-thrombin

neutral complex

When anti-thrombin binds to thrombin,

a neutral AT-T complex is formed.

AT-T : Antithrombin-thrombin

neutral complex

Neutral AT-T complex detaches from the heparin molecule.

Active site becomes available to again bind antithrombin.

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.

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.

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

(Human Explant)

• Explant after 1111 days

(> 3 years)

– Below-knee femoral to

tibioperoneal trunk bypass

– Outflow vessel

(peroneal) occluded

blood contact model

• Explant after 1,553 days

(> 4 years)

– Femoropopliteal bypass

blood contact model

(Human Explant)

• Explant after 2,939 days

(8 years)

– Femoral to posterior tibial bypass

with polyester Linton patch

– Distal anastomosis occluded

blood contact model

(Human Explant)

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

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.

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.

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

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

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

Below knee bypass with heparin bonded graft: More than 10...

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