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Surgical Bypass Summit — Session 1:
Vein versus heparin-bonded ePTFE: What do the data really say? — Prof. Raffaele Pulli

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Prof. Raffaele Pulli

The great saphenous vein (GSV) is superior to polytetrafluoroethylene (PTFE), and therefore should be preferentially used. Dr. Neville reviewed this topic1 and described data indicating that the GORE® PROPATEN® Vascular Graft (Gore & Associates) performed better than standard PTFE in a European-run randomized trial.2 Dr. Samson presented his single-center experience at Charing Cross in 2013, suggesting the GORE® PROPATEN® Vascular Graft performed better than standard GORE-TEX® Vascular Grafts (Gore & Associates) and ADVANTA PTFE Vascular Grafts (Atrium).3 Over the past decade there have been several other reports published on the subject, most of which were from Italian surgeons. The extensive Italian experience warranted creation of an Italian registry encompassing seven institutions throughout Italy. While not a randomized controlled trial, the registry provides insight into the real world of surgery and reflects what surgeons face in their daily practice.

Patients in the Italian Registry who received a below-the-knee bypass using vein had better primary patency than patients who received a bypass with heparin-bonded expanded polytetrafluoroethylene (ePTFE). Based upon these results, a GORE® PROPATEN® Vascular Graft score was created to summarize the circumstances under which the GORE® PROPATEN® Vascular Graft might perform as well as vein. A univariate analysis revealed the factors that affected primary patency (Table 1), and these factors were assigned point values (Table 2). For example, male gender was assigned one point and female gender was assigned two points. A low total point score indicated that a particular patient was a good candidate for receiving a GORE® PROPATEN® Vascular Graft preferentially to vein because the risk of thrombosis was low. An ANOVA test for thrombosis during follow-up was applied to the patients in the registry, and 7.502 was determined to be the cutoff score value (P < .001; R = 0.09), below which the GORE® PROPATEN® Vascular Graft could be used preferentially due to low risk of thrombosis, and above which vein would be likely to perform better. To validate this analysis, primary patency results for patients with a GORE® PROPATEN® Vascular Graft score of ≤ 7 who received bypasses with this device were compared to the primary patency results for vein bypasses (Figure 1). Although there was a trend toward better patency with vein, in contrast to the overall cohort, the difference was not statistically significant.

Figure 1.  Kaplan-Meier curve of estimated primary patency in patients undergoing a GORE® PROPATEN® Vascular Graft  bypass with a score ≤ 7 (blue line) compared with that obtained in patients undergoing a vein bypass (green line)  (Log-rank 3.1; P = .08).

Figure 1.  Kaplan-Meier curve of estimated primary patency in patients undergoing a GORE® PROPATEN® Vascular Graft bypass with a score ≤ 7 (blue line) compared with that obtained in patients undergoing a vein bypass (green line) (Log-rank 3.1; P = .08). 

TABLE 1.  UNIVARIATE AND MULTIVARIATE ANALYSIS FOR FACTORS AFFECTING PRIMARY PATENCY IN PATIENTS RECEIVING A HEPARIN-BONDED GRAFT
TABLE 2.  SCORES ASSIGNED BASED ON RESULTS OF UNIVARIATE ANALYSIS

By definition, registry results have no inclusion or exclusion criteria, and there was no request of homogeneous indication for the choice of grafts. Thus, the study was limited by the fact that it was registry-based and not randomized, and therefore the two treatment groups differed in several ways that likely reflected different approaches and patient selection among participating surgeons. As such, the calculated scores are primarily hypothesis generating, and should be validated in prospective studies and in other series of patients.

Summary

The GORE® PROPATEN® Vascular Graft offers satisfac-tory results in terms of patency and limb salvage rates. Moreover, venous adjuncts at the distal anastomosis seem to offer improved outcomes. Vein remains the best choice; however, in the case of unsuitable vein, a heparin-bonded PTFE graft is a good alternative with a comparable limb salvage rate. In some situations, on the basis of the above mentioned score, patients may benefit from the GORE® PROPATEN® Vascular Graft as a first choice.

*The results presented in this article are first-line results and the Italian registry group is looking to prospectively validate their scoring system in another region.

Prof. Raffaele Pulli is from the University of Florence in Florence, Italy. He has disclosed that he has received compensation from Gore for participating in the Summit and has received honoraria from Gore for writing this article. Dr. Pulli may be reached at [email protected] Walter Dorigo, MD, is from the University of Florence in Florence, Italy. He has stated that he has no financial interests related to this article. Prof. Carlo Pratesi is from the University of Florence in Florence, Italy. He has disclosed that he has received compensation from Gore for participating in the Summit.

  1. Neville RF. Role of surgical bypass in a limb preservation program. Endovascular Today. 2015;14(Suppl):5-6.
  2. Lindholt JS, Gottschalksen B, Johannesen N, et al. The Scandinavian Propaten((R)) trial: 1-year patency of PTFE vascular prostheses with heparin-bonded luminal surfaces compared to ordinary pure PTFE vascular prostheses: a randomised clinical controlled multi-centre trial. Eur J Vasc Endovasc Surg. 2011;41(5):668-673.
  3. Samson RH. Surgical bypass summit. Endovascular Today. 2015;14(Suppl):4.