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Lesion severity and treatment complexity are associated with outcome after percutaneous infra-inguinal intervention.

OBJECTIVES: Percutaneous revascularization has become increasingly utilized for the treatment of lower extremity ischemia. Patients with limb-threat have been shown to be at increased risk of failure, although the reasons for this remain unclear. This study analyzed factors associated with percutaneous treatment failure, focusing specifically on lesion characteristics and treatment complexity.

METHODS: We retrospectively reviewed percutaneous infra-inguinal interventions performed for peripheral occlusive disease between 2002 and 2005 using a prospectively maintained database. Lesion characteristics were assessed by angiography, and lesions were graded according to the TransAtlantic InterSociety Consensus (TASC) criteria. Patency was expressed by Kaplan-Meier method and compared by log-rank analysis. Multivariate Cox-regression analysis was used to assess significant factors on univariate analysis. Mean follow-up was 11.8 months.

RESULTS: A total of 324 interventions for claudication (55.8%), rest pain (18.4%), or tissue loss (25.8%) were analyzed, including 284 primary interventions and 40 re-interventions in 258 patients (mean age 72.1 +/- 10 years, 51.0% male). TASC lesion grades included: A (4.9%), B (29.3%), C (37.7%), and D (28.1%). Isolated single-level interventions (femoral, popliteal, or tibial) were performed in 38.9%, while two-level interventions were performed in 46.2% and three-level interventions in 14.9%. Overall primary patency (+/- SD) at 6, 12, and 18 months was 87 +/- 2%, 66 +/- 2% and 59 +/- 4%, respectively. Secondary patency at 6, 12, and 18 months was 89 +/- 2%, 76 +/- 3%, and 69 +/- 5%. One-year limb salvage rate (limb-threat patients) was 85 +/- 3%. Limb-threatening ischemia as the indication for intervention was most highly associated with failure of both primary and secondary patency and was associated with four indicators of lesion severity and treatment complexity, including increasing TASC grade, multilevel intervention, tibial intervention, and reduced tibial outflow. One-year primary patency was inversely correlated with TASC severity (TASC A-C: 67 +/- 6%, D: 61 +/- 4%; P < .05), multilevel intervention (76 +/- 5% and 49 +/- 9% for single vs multilevel, P = .002), distal interventions (74 +/- 5% and 57 +/- 7% for femoral vs tibial, P < .05), and decreased tibial runoff (83 +/- 6% and 52 +/- 6% for three- vs < three-vessels, P < .02). No differences in secondary patency or limb-salvage rates existed for these lesion- and treatment-related variables. Multilevel intervention and tibial intervention remained significant independently associated with primary patency on multivariate analysis.

CONCLUSIONS: Patients with limb-threatening ischemia are at increased risk of initial failure compared with claudicants, likely as a result of the increased prevalence of advanced lesion severity and treatment complexity, which are associated with decreased primary patency. However, this finding did not extend to secondary patency or limb-salvage in the overall patient population. Although additional studies with longer follow-up are needed, these findings argue that percutaneous intervention may still be considered as a primary treatment modality with the understanding that these patients may have higher re-intervention rates and may ultimately require salvage open surgical bypass for persistent failures of percutaneous therapy.

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