Percutaneous Femoropopliteal Bypass: 2-Year Results of the DETOUR System

Abstract

Purpose: This study investigated the 2-year safety and effectiveness of the PQ Bypass DETOUR system as a percutaneous femoropopliteal bypass. Materials and Methods: Seventy-eight patients with 82 long-segment femoropopliteal lesions were enrolled in this prospective, single-arm, multicenter study. The DETOUR system deployed Torus stent grafts directed through a transvenous route. Eligible patients included those with lesions of >10 cm and average of 371±55 mm. Key safety endpoints included major adverse events (MAEs) and symptomatic deep venous thrombosis in the target limb. Effectiveness endpoints included primary patency defined as freedom from ≥50% stenosis, occlusion, or clinically-driven target vessel revascularization (CD-TVR), primary assisted, and secondary patency. Results: Chronic total occlusions and severe calcium occurred in 96% and 67% of lesions, respectively. Core laboratory-assessed total lesion length averaged 371±51 mm with a mean occlusion length of 159±88 mm. The rates of technical and procedural success were 96%, with satisfactory delivery and deployment of the device without in-hospital MAEs in 79/82 limbs. The MAE rate was 22.0%, with 3 unrelated deaths (4%), 12 CD-TVRs (16%), and 1 major amputation (1%). Deep venous thrombosis developed in 2.8% of target limbs, and there were no reported pulmonary emboli. Primary, assisted primary, and secondary patency rates by the Kaplan–Meier analysis were 79±5%, 79±5%, and 86±4%, respectively. Conclusions: The PQ Bypass DETOUR system is a safe and effective percutaneous alternative to femoropopliteal open bypass with favorable results through 2 years. The DETOUR system provides a durable alternative to conventional endovascular modalities and open surgery for patients with long, severely calcified, or occluded femoropopliteal lesions.

“The Hunterian approach: Cordis Smart Stent safe and effective, but what about its use in long or severely calcified chronically occluded lesions… Let's get it done the first time”

“…The secondary patency rates by the Kaplan–Meier analysis was 86 ± 4%. These were very long lesions, much longer than any interventional study is ever reported, or for that matter, any percutaneous treated study 4 …”

“…These were very long lesions, much longer than any interventional study is ever reported, or for that matter, any percutaneous treated study. 4 Catheter Cardiovasc Interv. 2022;100:1088-1089. wileyonlinelibrary.com/journal/ccd 1088 | © 2022 Wiley Periodicals LLC.…”

“…These were very long lesions, much longer than any interventional study is ever reported, or for that matter, any percutaneous treated study. 4 So, the self-expanding stent is very effective in fairly short lesions, it can be safely utilized and it is very easily deployed.…”