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Objectives: Chronic total occlusions of the lower extremity can cause symptoms from claudication to tissue loss. A significant reason for failure of transcatheter revascularization in patients with chronic total occlusion is the inability to re-enter the true lumen distally after transversing the lesion. Two devices have been approved for such re-entry - Outback^® LTD^® Re-Entry Catheter (OBK) that utilizes fluoroscopy (Cordis, Johnson and Johnson Company, Bridgewater, NJ), and the Pioneer^® Catheter (PNR) which uses intravascular ultrasound (Medtronic, Minneapolis, MN). We aimed to examine our single center initial revascularization success and complication rates with these devices.
Methods: Patients who underwent endovascular procedures for lower extremity chronic total occlusion between December 2002 and July 2010 with OBK (N=36) or PNR (N=41) were selected. Patient characteristics, demographics, lesion morphology, and complications were examined. Case-mix adjusted forward step-wise multiple regression models ascertained independent risks for initial success.
Results: A true-lumen re-entry device was attempted in 77 limbs in 69 patients. There was no device related mortality in either group. Procedural complications were similar across groups. Surgeon selection was equally distributed within groups. Overall success rate of re-entry was 86%. OBK was successful in 75% [Aortoiliac: 10/13, Femoropopliteal: 17/23] and PNR was successful in 95% of limbs attempted [Aortoiliac: 33/34, Femoropopliteal: 6/7] (P=0.012). TASC lesion classification was similar between groups, while level D lesions with heavy calcification were present in 67% of the OBK failures for re-entry. Revascularization with percutaneous balloon angioplasty was completed in 8.3% of OBK and 2.4% of PNR, while adjunctive stents were placed in 55.6% of OBK and 90.2% of PNR (P=0.002, respectively). There were 11% periprocedural complications with OBK and 7% with PNR. Following risk-adjustment (Nagelkerke R² 0.61), Pioneer^® Catheter utilization independently predicted success [adjusted odds ratio 17.83, 95% confidence interval 1.094 - 290.404] compared to Outback^® LTD^® (area under receiver operating characteristic curve 0.85).
Conclusions: Both the Pioneer^® and Outback^® LTD^® Catheters are highly successful in achieving true-lumen re-entry in lower extremity chronically occluded lesions with minimal complications. At our center, failure to revascularize a limb with the Outback catheter primarily occurred in the TASC D lesion with heavy calcification. Although selection bias for the Pioneer^® Catheter may be contributory, use of the Pioneer^® device provides independent putative benefit that requires further exploration