Percutaneous Transmural Arterial Bypass for Treatment of Femoropopliteal Disease in Office-Based Labs: DETOUR2 Procedural Experience Across Clinical Settings

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.  The DETOUR2 IDE study was a multi-center center trial across both hospital and Office-Based Lab (OBL) settings. We report on the 3-year results of this innovative percutaneous revascularization in the OBL setting.

Materials and Methods:

The DETOUR2 IDE study is a prospective, single-arm 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. The primary safety endpoint was freedom from MAEs through 30 days. The primary effectiveness endpoint was patency through 12 months (absence of CD-TLR and recurrent target lesion diameter stenosis >50%). The 36-month assessments include mortality, major index limb amputation and venous events. Additionally, CD-TLR and primary patency, defined as the need for additional or secondary surgical or endovascular procedures, was also analyzed.

Results: 202 total patients were enrolled and treated with the DETOUR System. There were 35 patients that underwent percutaneous transmural arterial bypass with the DETOUR system in an OBL setting. Lesion characteristics of OBL subjects were similar to those of the entire cohort; 94% had CTO and mean lesion length was 337.1mm. Procedural characteristics (Total procedure time, EBL, contrast time, etc) were slightly better in the OBL cohort. Primary Patency was xx% and freedom from CD-TLR was xx% through 3 years in the OBL cohort (compared with the Hospital Cohort Primary Patency at xx% and freedom from CD-TLR at xx%). MAE in the OBL cohort was xx% with major index limb amputation of xx%. DVT and PE rate through 3 years was xx% and xx%, respectively.

Conclusion:

The 36-month outcomes from the DETOUR 2 in the OBL demonstrate clinical utility and safety of this novel therapeutic strategy in complex femoropopliteal lesions. DETOUR2 outcomes in the OBL is comparable to those in a hospital setting. PTAB provides a standardized technique with durable outcomes when open surgical revascularization is not viable or traditional endovascular therapy has failed.