Bypass to the ankle and foot in the era of endovascular therapy of tibial disease. Results and factors influencing the outcome.

AIM: Endovascular therapy (ET) is the treatment of choice for critical limb ischemia (CLI) and tibial arteries disease (TAD) in focal lesions with restorable run-off; ankle and foot bypass (BPG) is indicated in patients unfit for ET with foot or ankle arteries suitable for surgery. The aim of this study was to evaluate limb salvage (LS), primary patency (PP) and survival (S) of patients underwent BPG in the era of ET for TAD and to define the correlated prognostic factors. METHODS: Between February 2000 and November 2008, patients with CLI and TAD were collected prospectively in a data-base (demographics, Fontaine's stage, Texas University Wound Classification [TUC]of ulcers, risk-factors, TAD, techniques of foot revascularization and surgical factors). BPG was performed in tibial arteries occlusion longer than 4 cm or focal occlusion without line-flow to pedal arteries. Clinical and Duplex-ultrasound follow-up was performed at discharge, 1, 3, 6 months and every 6 months. LS, PP, and S rates were assessed with Kaplan-Meier method; factors influencing outcomes were sought by multivariate Cox proportional hazards model analysis. RESULTS: A total of 410 revascularizations were performed in patients with CLI and TAD; BPG in 153 patients (mean age: 69.3±10.6, male/female=117/36, diabetes mellitus=75.2% hyperlypidemia=54.9%, hypertension=87.6%, renal disease=32.7%, coronary arteries disease=51.6%, Fontaine stage IV=96.1%, TUC grade-III=65.4%, TUC stage-D=51%). All autologous grafts in 96.7% (non-reversed saphenous vein=74.5%, reversed=7.2%, composite vein graft=12.4%, arm's veins=2.6%). LS and S after 1 month were 88.2% and 97.1%, respectively. Mean follow-up was 23 months. At 12 and 36 months: LS 76.7% and 70.9%, PP 62.3% and 52.9%, S 91.5% and 74.6%. LS was negatively associated with age (HR=1.041 [95%CI=1.005-1.079]), infected ulcers (HR=3.377 [95%CI=1.571-7.258]), run-off arteries diameter <1.8 mm (HR=5.854[95% CI=2.274-15.070]). PP was negatively associated with hyperlipidemia (HR=2.555 [95% CI=1.418-4.603]), female gender (HR=2.125[95% CI=1.182-3.823]), run-off arteries diameter <1.8 mm (HR=6.165 [95% CI=2.774-13.699]), reversed saphenous graft (HR=3.105 [95% CI=1.166-8.272]), composite vein graft (HR=2.930 [95% CI=1.406-6.107]) and homograft (HR=2.762 [95% CI=1.040-7.333]); instead it is positively related with hypertension (HR=4.229 [95% CI=2.089-8.563]). S was negatively correlated with renal disease (HR=3.035 [95% CI=1.363-6.756]). CONCLUSION: BPG may be a reasonable first treatment for CLI patients with TAD unfit for ET; female gender, hyperlipidemia, use of reversed saphenous, composite vein or alternative grafts, foot infection and renal disease are associated with worse outcome.

BRAVISSIMO: 12-month results from a large scale prospective trial.

The BRAVISSIMO study is a prospective, non-randomized, multi-center, multi-national, monitored trial, conducted at 12 hospitals in Belgium and 11 hospitals in Italy. This manuscript reports the findings up to the 12-month follow-up time point for both the TASC A&B cohort and the TASC C&D cohort. The primary endpoint of the study is primary patency at 12 months, defined as a target lesion without a hemodynamically significant stenosis on Duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without target lesion revascularization (TLR) within 12 months. Between July 2009 and September 2010, 190 patients with TASC A or TASC B aortoiliac lesions and 135 patients with TASC C or TASC D aortoiliac lesions were included. The demographic data were comparable for the TASC A/B cohort and the TASC C/D cohort. The number of claudicants was significantly higher in the TASC A/B cohort, The TASC C/D cohort contains more CLI patients. The primary patency rate for the total patient population was 93.1%. The primary patency rates at 12 months for the TASC A, B, C and D lesions were 94.0%, 96.5%, 91.3% and 90.2% respectively. No statistical significant difference was shown when comparing these groups. Our findings confirm that endovascular therapy, and more specifically primary stenting, is the preferred treatment for patients with TASC A, B, C and D aortoiliac lesions. We notice similar endovascular results compared to surgery, however without the invasive character of surgery.

Dysfunctional vasa vasorum in diabetic peripheral artery obstructive disease with critical lower limb ischaemia.

OBJECTIVES AND DESIGN: To establish whether in diabetic patients with peripheral artery obstructive disease (PAOD) vasa vasorum (vv) neoangiogenesis is altered with increased arterial damage. MATERIALS: Thirty-three patients with PAOD and critical lower limb ischaemia, 22 with type II diabetes. METHODS: Immunohistochemistry for endothelial cell markers (CD34 and von Willebrand Factor); real-time reverse transcription polymerase chain reaction (RT-PCR) to quantify arterial wall expression of vascular endothelial growth factor (VEGF); enzyme-linked immunosorbent assay (ELISA) to assess blood VEGF; flow cytometry to detect circulating endothelial cells (CECs). RESULTS: Patients with PAOD and diabetes have a higher frequency (60% vs. 45%) of advanced atherosclerotic lesions and a significant reduction (p = 0.0003) in CD34(+) capillaries in the arterial media. Adventitial neoangiogenesis was increased equally (CD34(+) and vWF(+)) in all patients. Likewise, all patients have increased CEC and VEGF concentration in the blood as well as in-situ VEGF transcript expression. CONCLUSIONS: Patients with PAOD have remarkable arterial damage despite increased in-situ and circulating expression of the pro-angiogenic VEGF; a dysfunctional vv angiogenesis was seen in diabetics which also showed a higher frequency of parietal damage; it is suggested that in diabetic arterial wall, injury is worsened by vv inability to finalise an effective VEGF-driven arterial wall neoangiogenesis.