Subintimal angioplasty with the aid of a re-entry device for TASC C and D lesions of the SFA.
OBJECTIVE
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.
Setacci
C
C
Department of Surgery, University of Siena, Siena, Italy. setacci@unisi.it
Chisci
E
E
de Donato
G
G
Setacci
F
F
Iacoponi
F
F
Galzerano
G
G
D000368:Aged; D000369:Aged, 80 and over; D000792:Angiography; D017130:Angioplasty / Q000295:instrumentation*; D002406:Catheterization, Peripheral / Q000295:instrumentation*; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging; D005500:Follow-Up Studies; D006801:Humans; D007511:Ischemia / Q000000981:diagnostic imaging / Q000628:therapy*; D007866:Leg / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D017539:Tunica Intima; D018616:Ultrasonography, Doppler, Duplex