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Home > Vascular Annual Meeting > RR21. Treatment of Infrainguinal Critical Limb Ischemia...

RR21. Treatment of Infrainguinal Critical Limb Ischemia Using a Heparin-Bonded ePTFE Graft: Mid-Term Results from a Multicenter Registry

Walter Dorigo1, Raffaele Pulli1, Patrizio Castelli2, Giovanni De Blasis3, Vittorio Dorrucci4, Fiore Ferilli5, Vincenzo Monaca6, Enrico Vecchiati7, Carlo Pratesi1
1University of Florence, Florence, Italy; 2University of Insubria, Varese, Italy; 3SS. Filippo e Nicola Hospital, Avezzano, Italy; 4Umberto I Hospital, Venice-Mestre, Italy; 5Santa Maria Hospital, Terni, Italy; 6V.E. Ferrarotto S. Bambino Hospital, Catania, Italy; 7Santa Maria Nuova Hospital, Reggio Emilia, Italy

OBJECTIVES: To report mid-term results of infrainguinal bypasses performed with a heparin-bonded ePTFE graft in patients presenting with critical limb ischemia.

METHODS: Over a 6 year period ending in 2007, 354 patients presenting with critical limb ischemia underwent infrainguinal revascularization using a heparin-bonded ePTFE graft in seven Italian vascular centers. Preoperative, intraoperative and follow-up data were collected in a multicenter registry. Patients were predominantly male (80.5%), with a mean age of 72.2 years. Mean preoperative abi was 0.40 and 163 (46%) of patients were diabetic. Intervention consisted of a femoral to below-knee bypass in 282 (80%) patients, while the remaining 72 had a femoral to above-knee bypass. Follow-up consisted of clinical examination, abi´s, and graft duplex exam at 1, 3, 6, 12 months and every 6 months thereafter. Early and mid-term results were analyzed in terms of primary and secondary graft patency, limb salvage and survival rates with univariate and multivariate (Cox regression) analysis.

RESULTS: Six perioperative deaths occurred (1.7%). Thirty-day primary graft patency was 92.1% and limb salvage was 96.6%. Follow-up was available in 97% of patients with a mean duration of 26 months (S.D. 17.6, range 1-72). Cumulative estimated 48-month primary and secondary patency, limb salvage and survival rates were 52%, 61%, 80% and 80%, respectively.
At univariate analysis the factors negatively affecting the limb salvage during follow-up were the presence of ischemic ulcers or gangrene (log-rank 5.2, p=0.02), the presence of only one patent tibial vessel (log-rank 33.4, p<0.001), redo surgery (log-rank 21.2, p<0.001), the site (below-knee) of distal anastomosis (log-rank 3.7, p=0.05), and the need for adjunctive distal procedures (log-rank 4.2, p=0.04). At multivariate analysis only redo surgery (p=0.03, 95% CI 0.28-0.94), poor runoff score (p=0.006, 95% CI 1.7-3.2) and preoperative clinical status (p=0.05; 95% CI 0.9-3.2) were independently associated with lower limb salvage rates.

CONCLUSIONS: The use of a heparin-bonded ePTFE graft provides good early and mid-term results, with low rates of late amputations. Primary and secondary patency make this graft an excellent alternative to autologous saphenous vein when it is absent, unsuitable or of poor quality.

AUTHOR DISCLOSURES: W. Dorigo, None; R. Pulli, None; P. Castelli, None; G. De Blasis, None; V. Dorrucci, None; F. Ferilli, None; V. Monaca, None; E. Vecchiati, None; C. Pratesi, None.