Quality of Life in Patients After Percutaneous Transmural Arterial Bypass: Complex Femoropopliteal Disease: Clinical Impact of Femoropoliteal Revascularization in the DETOUR-2 Study

Purpose: Percutaneous Transmural Arterial Bypass (PTAB) with the DETOUR System is a novel endovascular procedure to treat complex femoropopliteal disease including long lesions, heavy calcification, and CTO’s. The DETOUR System uses standard endovascular techniques with a unique crossing device and stent graft to create a percutaneous femoropopliteal bypass. Prespecified secondary objectives included health-related quality of life (HRQoL) outcomes.

Materials and Methods: The DETOUR-2 IDE study is a prospective, single-arm, multi-center center trial across 36 sites for lesions >20 cm long in the femoropopliteal segment with Rutherford Stage 3-5 disease. Follow-up visits were conducted at 30 days, 6 months, and annually through 3 years. HRQoL was assessed at 1 month and 12 months using Vascular Quality-of-Life (VascuQoL), European Quality-of-Life-5D (EQ-5D), the Short Form-12 (SF-12) and a 6 Minute Walk Test. The 6 Minute Walk Test is summarized by a sub cohort as only select clinical sites perform this routinely.

Results: 202 patients were enrolled and treated with the DETOUR System; 96% had CTO. Mean lesion length was 327+/-61 mm. Primary clinical success rate at 3 years was 96.7The rate of FF CD-TLR through 3 years for DETOUR patients was 66.8%. HRQoL results will be outlined in the future.

Conclusion: The 36-month outcomes from the DETOUR 2 demonstrate clinical utility and safety of this novel therapeutic strategy in complex femoropopliteal lesions. These long-term results suggest that PTAB with the DETOUR System achieves similar results to open surgical prosthetic femoropopliteal bypass. In addition, HRQoL outcomes demonstrated clinically meaningful improvements.