Kaisar J, Chen A, Cheung M, Kfoury E, Bechara CF, Lin PH. Comparison of propaten heparin-bonded vascular graft with distal anastomotic patch versus autogenous saphenous vein graft in tibial artery bypass. Vascular 2018;26(2):117-125.

Abstract

Introduction:

Heparin-bonded expanded polytetrafluoroethylene grafts (Propaten, WL Gore, Flagstaff, AZ, USA) have been shown to have superior patency compared to standard prosthetic grafts in leg bypass. This study analyzed the outcomes of Propaten grafts with distal anastomotic patch versus autogenous saphenous vein grafts in tibial artery bypass. 

Methods:

A retrospective analysis of prospective collected data was performed during a recent 15-year period. Sixty-two Propaten bypass grafts with distal anastomotic patch (Propaten group) were compared with 46 saphenous vein graft (vein group). Pertinent clinical variables including graft patency and limb salvage were analyzed. 

Results:

Both groups had similar clinical risk factors, bypass indications, and target vessel for tibial artery anastomoses. Decreased trends of operative time (196 ± 34 min vs. 287 ± 65 min, p = 0.07) and length of hospital stay (5.2 ± 2.3 days vs. 7.5 ± 3.6, p = 0.08) were noted in the Propaten group compared to the vein group. Similar primary patency rates were noted at four years between the Propaten and vein groups (85%, 71%, 64%, and 57%, vs. 87%, 78%, 67%, and 61% respectively; p = 0.97). Both groups had comparable secondary patency rates yearly in four years (the Propaten group: 84%, 76%, 74%, and 67%, respectively; the vein group: 88%, 79%, 76%, and 72%, respectively; p = 0.94). The limb salvage rates were equivalent between the Propaten and vein group at four years (84% vs. 92%, p = 0.89). Multivariate analysis showed active tobacco usage and poor run-off score as predictors for graft occlusion.

Conclusions:

Propaten grafts with distal anastomotic patch have similar clinical outcomes compared to the saphenous vein graft in tibial artery bypass. Our data support the use of Propaten graft with distal anastomotic patch as a viable conduit of choice in patients undergoing tibial artery bypass.

Disclaimer:

Gore products referenced within, if any, are used within their FDA approved/cleared indications. Gore does not have knowledge of the indications and FDA approval/clearance status of non-Gore products. Gore makes no representations as to the surgical techniques, medical conditions, or other factors that may be described in the article(s). The reader is advised to contact the manufacturer for current and accurate information.

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 Graft in 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 Graft for 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.
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