The impact of True Lumen Reentry Devices on Early and Late Outcomes in Patients with Chronic Femoropopliteal Total Occlusions
Michael A. Sywak, MD, Mariel Rivero, MD, Sikandar Z. Khan, MBBS, Gregory S. Cherr, MD, Linda M. Harris, MD, Maciej L. Dryjski, MD, Hasan H. Dosluoglu, MD.
SUNY at Buffalo, Buffalo, NY, USA.
Objectives: Luminal reentry devices have been used to increase the successful crossing of chronic total occlusions (CTO), however their impact on long-term outcomes is not known. Our goal was to assess the early and long-term outcomes with the use of these devices in crossing femoropopliteal CTOs.
Methods: All patients who had endovascular recanalization of femoropopliteal CTO between 08/2003-12/2016 were included. Outcomes following wire-only crossing were compared to fluoroscopy-guided (Outback), or ultrasound-guided (Pioneer) catheters after failure of wire-crossing. Results: Crossing was attempted in 405 limbs (358 patients; 99% males, diabetes (49%), renal insufficiency (26%), chronic limb-threatening ischemia (62%)). Mean occlusion/stenosis/stented lengths were 14.7±9.9cm, 10.7±7.0cm, 20.5±12.8cm. Glidewire crossing was unsuccessful in 84 (21%); 6% in TASCII A, 8% in TASCII B, 17% in TASCII C, and 27% in TASCII D lesions (P=0.008). Outback (n=19) and Pioneer (n=53) reentry catheters were used in 1 TASCII A (5%), 3 TASCII B (8%), 21 TASCII C (16%) and 47 TASCII D (22.0%) lesions, decreasing the failure rate to 6% (22/24 TASCII D, one TASCII A, one TASCII C, 70% due to extreme calcification). Success rate for Outback was 68%, vs. 89% for Pioneer (P=0.042). Of 24 patients who failed crossing, 15 (63%) had bypass, 2 were successfully recanalized later, one had amputation, 6 were managed conservatively. Stents were used in 89% (88% with wire, 95% with reentry, P=0.117). Crossing success increased from 87% to 97% after 2007 (P<0.001) with similar use of reentry devices (15% vs 19%, P=0.373). Mean follow-up was 44±35 months. Following successful recanalization (N=381), there was no difference in primary patency (24/60 months; 54±7%/35± 9% in reentry vs 56±3%/39±4% in wire-only (P=0.506) (Figure), or secondary patency (72±7%/49±9.9% vs. 75±3%/60±4% (P=0.623). In CLTI patients (n=233), 60-month limb salvage was 97±3% in reentry, 82±3% in wire-only group (P=0.088).
Conclusions: Reentry devices may be needed in about 20% of patients undergoing recanalization of femoropopliteal CTOs, mostly in TASC D lesions, with ultrasound-guided reentry device having the higher success rate. Similar patency and limb salvage rates were observed in patients who required use of a reentry device suggesting their use does not adversely impact long-term outcomes. 
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