Author(s): Setacci C, Chisci E, de Donato G, Setacci F, Iacoponi F,
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Abstract AIM: The aim of this prospective study was to assess the clinical effectiveness and related midterm patency of subintimal angioplasty (SAP) in patients suffering from critical limb ischaemia (CLI) in a single tertiary care university centre. The secondary aim was to evaluate the safety and clinical effectiveness of using a re-entry device when re-canalisation by SAP was unsuccessful. METHODS: From January 2005 to December 2007, consecutive patients suffering from CLI (Rutherford clinical categories: 4-6) were treated with SAP. All patients included in the study had occluded SFA (TASC C and D) and underwent clinical and ultrasound follow-up examinations at day 30 and at 3, 6, 9 and 12 months, and then yearly. A re-entry device (Outback, Cordis Corporation, Miami Lakes, Florida, USA in all cases) was only used when re-canalisation by simple SAP was unsuccessful, and stenting was used when residual stenosis was >30\% or there was a flow-limiting dissection. Factors that could modify the outcome were analysed. RESULTS: In this study, 145 patients were treated, with a technical success rate of 83.5\% (121 of 145) for simple SAP. Stenting was performed in 43\% (n=62) of successful SAP procedures. No death occurred in the perioperative period, while the 30-day mortality was 4.8\% (7 of 145). The re-entry device (Outback) was used in 24 cases (16.5\%). The technical success of the re-entry device was 79\% (19 of 24), with a 90\% success rate of stent placement at the site of re-entry. Complications occurred in 6.2\% of all procedures (n=9) (three arterial perforations (2.1\%), three distal embolisations (2.1\%), two femoral artery pseudo-aneurysms (1.4\%) and one arterio-venous fistula (0.7\%)). Factors capable of independently affecting the patency were renal insufficiency (p=0.03), current smoking (p=0.01) and diabetes (p=0.04). The primary patency at 1 and 3 years was 70\% and 34\% and the secondary patency at 1 and 3 years was 77\% and 43\%, respectively. At the same time intervals, the limb-salvage rate was 88\% and 49\%. CONCLUSIONS: SAP with the aid of a re-entry device for TASC C and D lesions of the SFA seems to be safe and clinically effective in patients suffering from CLI, according to the experience at our centre. Further follow-up and more data are necessary to confirm these findings.
This article was published in Eur J Vasc Endovasc Surg
and referenced in Journal of Health Education Research & Development