PTFE bypass or thrupass for superficial femoral artery occlusion? A randomised controlled trial.

UNLABELLED: Early results of a thrupass endograft in the treatment of femoral lesions are promising. Less morbidity and better cost-effectiveness are suggested to be achieved in the treatment of chronic lower limb ischaemia with endovascular treatment compared to surgical treatment. PATIENTS AND METHODS: This randomised multicentre trial aimed to enroll a group of 60+60 patients for the treatment of 5-25-cm occlusions of superficial femoral artery (SFA) to be followed up for 3 years. Patients were treated either with endoluminal PTFE thrupass (WL Gore & Ass) or with surgical polytetrafluoroethylene (PTFE) bypass to proximal popliteal artery. Primary patency at 3 years was scheduled to be the primary end-point and secondary patency, functional success, costs and quality of life the secondary end-points. RESULTS: A sample of 100 consecutive SFA occlusions in one of the centres revealed that only 4% of the lesions were amenable for the study. The trial was prematurely terminated due to the results of an interim analysis at the time when 44 patients were recruited: the 1-year primary patency (excluding technical failures) was 48% for thrupass and 95% for bypass (p=0.02). The patency difference in favour of surgical bypass over endovascular thrupass was also sustained after completion of 1-year follow-up, the primary patencies being 46% and 84% at 1 year with grossly equilinear life-table curves thereafter (p=0.18), respectively. The corresponding secondary patencies were 63% and 100% (p=0.05) when excluding technical failures and 58% and 100% (p=0.02) according to intention-to-treat analysis. Secondary outcomes were thus not analysed. CONCLUSION: Treatment of SFA occlusions (TASC IIB and C or Imelda Ia and II) should be done by PTFE bypass rather than by PTFE thrupass, as thrupass is connected with worse early outcome. These results represent only a small category of femoral disease.

Complications following high-dose percutaneous ethanol injection into hepatic tumors.

PURPOSE: Percutaneous ethanol injection therapy (PEIT) with a 2-10 ml ethanol dose per session is widely used in the treatment of small hepatocellular carcinoma. Larger doses have been restricted for fear of complications. The aim of the present study was to make a retrospective evaluation of the complications following treatment of hepatic tumors with high doses of ethanol (up to 200 ml). MATERIAL AND METHODS: The medical records of 15 patients treated repeatedly with PEIT were reviewed retrospectively to detect side effects or complications. Eleven of these patients had undergone transarterial chemoembolization (TAE) prior to PEIT. Of 173 ethanol injections in doses of 2-200 ml (mean 49 ml), more than 10 ml had been injected on 138 occasions. The chi-square test was used to evaluate the differences in pain frequency among the various dosage groups. RESULTS: Serious complications did not occur. Pain was a common side effect, occurring in 48% of the procedures. Immediate pain during the treatment was related to the ethanol dose and increased significantly with increasing doses (p < 0.01). Other side effects were rare. CONCLUSION: PEIT with doses higher than previously reported seems to be safe. This should encourage further clinical studies that aim at fully working out the clinical value of such treatment.