The key to successful limb salvage and long-term patency is minimizing immediate failure. The Six-L Study aims to compare CELA Vs TBA outcomes in patients with CLI, TASC DE.
From June05-June08, 56 EvRs were performed for TASC DE; 32 using TBA and 24 using CELA. All patients were Rutherford Category 4/5 with mean age 69years (48-96yrs) and comparable demographics, vascular-related risk factors and runoff grading.
Technical Success was 83% for CELA vs. 75% for TBA (χ2=0.090). Improvement to Rutherford Category ≤3 occurred in 64% of CELA vs. 57% of TBA (χ2=0.076) with hemodynamic Success in 57% in CELA vs. 66% of TBA (χ2=0.093). Sustained clinical improvement lasted 14months with CELA vs.11months with TBA (χ2=0.082). Primary, primary-assisted and secondary patency all improved with CELA (12 vs.10months (χ2=0.267), 18 vs.16months (χ2=0.101) and 23 vs. 18months (χ2=0.042), respectively). TLR (12 vs 9months, χ2=0.174), 3-year limb salvage (91% vs. 88%, χ2=0.657) and freedom from MAE (11 vs. 9months, χ2=0.073) improved with CELA.
Prospective Clinical Prelude showed ostial lesions with distal poor run off have reduced prospect of distal embolisation and ameliorated PTA if CELA is used primarily in instances where the wire can cross but not the Balloon. Initially compromised endeavours at Crural PTA can be treated successfully with redo PTA without spoiling subsequent attempts at bypass grafting.
Tibial EvR bestows Exceptional Outcome in CLI TASC DE .Both CELA & TBA enhance Anatomical, Clinical and Technical Success Rates in Complex Tibial Vessel Lesions. However, CELA has superior TLR, Survival from MAE and Secondary Patency.