Bailout Revascularization of Chronic Femoral Artery Occlusions With the New Outback Catheter Following Failed Conventional Endovascular Intervention

Abstract

PURPOSE: To report the application of a true lumen re-entry device in the bailout treatment of chronic total occlusions (CTO) of the superficial femoral artery (SFA) after failed angioplasty. METH-ODS: Nineteen patients (12 men; mean age 81 years, range 61-97) with 20 SFA CTOs and Rutherford category 2 to 5 ischemia were prospectively evaluated. All CTOs had unsuccessful recanalization using conventional techniques and were subsequently treated with the Outback LTD catheter. Follow-up at 3, 6, and 12 months included ankle/toe pressure measurement and pulse volume recordings. Endpoints were revascularization rate, target lesion revascularization, and limb salvage. RESULTS: Revascularization was achieved in 95% of the cases. There were 2 (10%) periprocedural complications unrelated to the re-entry device, which were resolved by endovascular or surgical treatment. The target lesion revascularization rate was 10%, with the 2 events occurring at 3 and 6 months, respectively, in patients with Rutherford category 4-5 ischemia. There was one below-the-knee amputation in the patient with failed revascularization. CONCLUSION: The acute failure of endovascular treatment of SFA CTOs is most often due to an inability to re-enter the true lumen after the occlusion is crossed in a subintimal plane. Bailout revascularization with the Outback LTD catheter is highly successful and shows a low device-related complication rate. This needle-and fluoroscopic-based re-entry device increases the endovascular success rate and is therefore expanding the minimally invasive treatment options for surgically unfit patients.

Subintimal angioplasty with a true reentry device for treatment of chronic total occlusion of the arteries of the lower extremity

“…Previous studies have reported variable success rates of 80%-100% [10]. A recent study reported a success rate of 95%, but there were only 19 patients in that study [11]. Another recent study reported a success rate of 79% with 24 patients [12].…”

Limitations of the Outback LTD re-entry device in femoropopliteal chronic total occlusions

“…8 Similar to other reports, failure to achieve successful endoluminal therapy was most often due to failure of the device to re-enter the true lumen. 2,[4][5][6][7] The current review has identified heavy calcification at the proposed re-entry site as the primary reason for device failure. In the series from Hausegger et al, 6 two failures (20%) to re-enter the true lumen were attributed to heavy calcification of the artery.…”

“…Previous studies have shown variable success of 50% to 100% with these re-entry devices in the treatment of infrainguinal CTOs. [2][3][4][5][6][7] Previous reports indicate the primary limitation of these devices is heavy calcification at the proposed site of true lumen re-entry; however, these were small series that included various vascular beds. 2,6,7 In this study, we examined the success and the predictors of failure of using the Outback LTD device in CTOs of the femoropopliteal segment that have failed conventional re-entry techniques.…”

Novel devices and specialized techniques in recanalization of peripheral artery chronic total occlusions (CTOs) — A literature review

“…Hausegger and colleagues [17] first published their single-center study about the initial experience with the catheter system in 10 patients suffering from CTOs of the superficial femoral or popliteal arteries. Other single-center and small-sample studies [18][19][20][21][22][23][24][25] reported the result of using this device to recanalize the iliac artery and distal femoral artery CTOs. These reports have shown a very high technical success rate.…”