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Samson RH, Morales R, Showalter DP, Lepore MR, Nair DG.  Heparin-bonded expanded polytetrafluoroethylene femoropopliteal bypass grafts outperform expanded polytetrafluoroethylene grafts without heparin in a long-term comparison.  Journal of Vascular Surgery 2016;64(3):638-647.

Abstract

Introduction:

Expanded polytetrafluoroethylene (ePTFE) grafts have become an acceptable prosthetic alternative to autologous vein for infrainguinal arterial reconstructions. Recently, heparin bonding to the graft's luminal surface has been used as an adjunctive method of improving graft patency. We retrospectively evaluated a prospective experience with heparin-bonded ePTFE (HePTFE) vs the results of a prior experience with standard ePTFE (SePTFE) to compare patency rates in above-knee (AK) and below-knee (BK) femoropopliteal bypass through the 5-year follow-up.

Methods:

Prosthetic femoropopliteal bypasses performed by our four-surgeon group were constructed using 6-mm SePTFE grafts before August 2007. Subsequently, all such bypasses were constructed using 6-mm HePTFE (Propaten graft; W. L. Gore & Associates, Flagstaff, Ariz). The surgical technique used in all cases throughout the study was similar irrespective of surgeon or graft material. Loss of primary patency was defined by graft thrombosis; duplex scan confirmed graft failure. Descriptive estimation of patency rates was carried out using standard Kaplan-Meier methods. Cox proportional hazards regression was used to analyze relationships between predictors and time to loss of patency.

Results:

There were 192 AK (87 Propaten, 105 SePTFE) and 60 BK (42 Propaten, 18 SePTFE) grafts. Overall primary patency for Propaten was statistically better than SePTFE at years 1 (93.6% vs 84.2%), 2 (79.7% vs 73.8%), 3 (79.7% vs 69.5%), 4 (74.5% vs 59.9%) and 5 (74.5% vs 56.2%; log-rank test, P = .036). Five-year primary patency was superior for Propaten AK grafts (85.2% vs 59.3%; log-rank test, P = .028) and for Propaten BK grafts (59.6% vs 0.0/undeterminable; log-rank test, P = .016). Variables significantly associated with loss of patency for Propaten and SePTFE were claudication (hazard ratio [HR], 0.41), age (HR, 0.95), isolated popliteal artery (HR, 3.1-4.4), and ankle-brachial index after the procedure (HR, 0.10). Controlling for conduit effect, clopidogrel use did not significantly affect patency (P = .076). No grafts were associated with heparin-induced thrombocytopenia.

Conclusions:

These data show that the Propaten HePTFE graft offered significantly better long-term patency over the SePTFE graft, suggesting Propaten as the prosthetic graft of choice for bypasses to the femoropopliteal artery when autologous vein is unavailable or inappropriate.


IFU Consult instructions

Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. RXOnly

INDICATIONS FOR USE IN EUROPE: GORE® PROPATEN® Vascular Graft is indicated for patients who require replacement or bypass of peripheral vessels due to occlusive or aneurysmal diseases or trauma, or for patients who require arteriovenous hemodialysis access in the upper or lower extremities due to end-stage renal disease (ESRD).

GORE® PROPATEN® Vascular Graft Configured for Pediatric Shunt is indicated for staged palliative repair of cyanotic congenital heart disease (CCHD). 

CONTRAINDICATIONS: DO NOT use the GORE® PROPATEN® Vascular Graftin patients with known hypersensitivity to heparin, including those patients who have had a previous incidence of Heparin-Induced Thrombocytopenia (HIT) type II.

DO NOT use any of the below configurations of GORE® PROPATEN® Vascular Graftfor coronary artery bypass or cerebral reconstruction procedures: 

  • GORE® PROPATEN® Vascular Graft Integrated Rings
  • GORE® PROPATEN® Vascular Graft Fixed Ring
  • GORE® PROPATEN® Vascular Graft Removable Ring
  • GORE® PROPATEN® Vascular Graft Removable Ring Axillobifemoral 

DO NOT use GORE® PROPATEN® Vascular Graft as a patch. If cut and used as a patch, GORE® PROPATEN® Vascular Graft may lack adequate transverse strength.

FOR PATCHING APPLICATIONS: For cardiovascular procedures requiring patch materials, use the appropriate GORE® ACUSEAL Cardiovascular Patch. 

Product may not be available in all countries. Please check with your Gore representative for availability.