The first commercial implantation of the percutaneous transmural arterial bypass (PTAB) system, approved in June 2023 for long-segment, complex femoropopliteal disease, was performed by Cleveland Clinic vascular surgeons. This system, known as the DETOUR™ System, is changing the treatment landscape by providing a minimally invasive option for patients who would otherwise require open surgical bypass.
How PTAB Works
The PTAB system facilitates the creation of a percutaneous femoropopliteal bypass using standard endovascular techniques, a crossing device, and a stent graft. The procedure involves entering the superficial femoral artery (SFA) and using the crossing device to enter the femoral vein, at least 3 cm distal to the vessel's origin. The device is then guided down the femoral vein and re-enters the popliteal artery, landing above the tibial plateau in a healthy section of the artery. Stent grafts are then placed from the distal end to the SFA origin.
According to J. Eduardo Corso, MD, a vascular surgeon, "The system allows us to access an area of the popliteal artery behind the knee. With PTAB we can access the popliteal artery further down than the above-knee target and stent all the way down to the knee. The stents perform well in that area, which is a spot where many stents traditionally do not."
Benefits of PTAB
PTAB offers several advantages over traditional bypass surgery. Sean Lyden, MD, Chair of Vascular Surgery at Cleveland Clinic, notes, "Instead of a three- or four-day hospital stay and a 3% to 4% risk of major infection with bypass surgery, patients get an overnight stay or outpatient procedure with PTAB and almost no infection risk. When patients learn about PTAB, they’re eager to consider it."
Dr. Corso also highlights that PTAB does not compromise potential future bypasses to locations below the knee, and results to date compare favorably to prosthetic bypasses, especially those below the knee.
Patient Selection
While PTAB offers significant benefits, it is not suitable for all patients with peripheral artery disease (PAD). The system is officially indicated for patients with long lesions (20-46 cm in length), representing approximately 10% of PAD patients. PTAB is not appropriate for patients with diseased or occluded popliteal arteries or those with compromised venous systems.
Dr. Corso indicates that PTAB is a viable option for patients with failed previous stenting procedures or those for whom open surgical bypass is difficult or too risky due to potential poor wound healing.
Clinical Trial Data and Expanded Applications
The formal indication for PTAB is based on data from the DETOUR 1 and 2 clinical trials. Pooled two-year data from these trials, involving 273 patients, demonstrated a clinical success rate of 95.3%, primary patency of 69.2%, freedom from target vessel revascularization of 68.1%, and freedom from symptomatic deep vein thrombosis of 96.7%.
As clinical experience grows, the use of PTAB is expanding beyond its initial trial-based indication. Cleveland Clinic is advocating for a measured, iterative approach to these expansions, focusing on reproducibility of results. Examples include considering use in patients with slightly smaller vessel diameters, increasing the puncture distance beyond the tibial plateau, and considering use in the setting of a non-patent proximal SFA if it can be recanalized.
Postmarket Registry
To accurately understand real-world use of PTAB, the system’s manufacturer has initiated a postmarket registry, in which Cleveland Clinic is participating. This registry is part of the Society for Vascular Surgery’s Vascular Quality Initiative.
According to Aravinda Nanjundappa, MBBS, MD, a Cleveland Clinic interventional cardiologist and vascular medicine specialist, "While PTAB is currently indicated for lesion lengths of 20 to 46 cm, it has shown promise in treating failed prior interventions and patients unsuitable for traditional bypass, and this ongoing data collection is likely to gradually expand its application to more patients."
