AHN Surgeons Pioneer Minimally Invasive PAD Treatment with DETOUR System

More than 12 million people in the U.S. have been diagnosed with peripheral artery disease (PAD).* Many do not qualify for treatment options such as surgical bypass, balloon angioplasty, or stent placement due to comorbidities or their overall risk profile.

Now, patients have access to a promising new treatment offered by the vascular surgeons at AHN Cardiovascular Institute. The AHN Cardiovascular team was the first in western Pennsylvania to successfully treat complex PAD by performing minimally invasive percutaneous transmural arterial bypass (PTAB) using the DETOUR System by Endologix.

A novel endovascular approach to treating complex PAD

Powered by innovative DETOUR technology, the procedure creates a new pathway for blood to flow around the clogged area. This restores adequate oxygenated blood flow to minimize or eliminate symptoms.

The procedure is especially promising for patients who have long femoropopliteal lesions (>20 cm) — which are more challenging to treat than smaller lesions — a history of repeated endovascular procedures, or little chance of being viable candidates for bypass surgery.

The DETOUR System consists of:

1. The ENDOCROSSTM Device – A delivery tool to create proximal and distal anastomoses that allow communication from artery-to-vein-to-artery.
2. TORUSTM Stent Grafts – These are deployed into the femoral vein from the popliteal artery and into the superficial femoral artery from the femoral vein.

During the PTAB procedure

Surgeons gain contralateral arterial access through a small incision in the groin and insert the ENDOCROSS device. A small incision is made in the ankle to allow ipsilateral venous access of a snare device.

Surgeons utilize ENDOCROSS with the snare device to achieve angioplasty of both the proximal and distal arteriovenous crossings. The TORUS stent graft is then placed in the distal vessel and extended further to the origin of the superficial femoral artery.

The system creates a percutaneous endovascular femoropopliteal bypass — a "detour" around the arterial lesion. Blood then flows from the artery into the femoral vein and back into the artery, circumventing the patient's blockage.

Proven safe and clinically effective

The DETOUR system earned Breakthrough Device Designation from the US Food and Drug Administration (FDA) in 2020 and received approval from the FDA in 2023. The system has been proven safe and clinically effective in several clinical trials:**

• 93% of patients free from MAEs (major adverse events) through 30 days.
• 72% of patients with primary patency at 12 months.
• 78% of patients with primary-assisted patency at 12 months.

Primary safety endpoint:

Freedom from an MAE through 30 days, including:

1. Major amputation of the limb being treated.
2. Clinically driven target lesion revascularization.
3. Deep vein thrombosis.
4. Death.

Primary effectiveness endpoint:

Primary patency at 1 year, defined as achieving patency without the need for secondary surgical or endovascular procedures.

Additional key effectiveness endpoint:

Primary-assisted patency, defined as maintaining patency, with only minor additional interventions.

Nationally recognized experts in complex cardiac care

AHN Cardiovascular Institute is deeply committed to providing patients with the latest groundbreaking surgical therapies and nationally recognized for pioneering approaches to complex cardiovascular diseases, especially for patients with medication-resistant cases and those with limiting comorbidities.

AHN Wexford Hospital has been lauded for exceptional care delivery and patient safety scores. It serves as a primary location for complex care delivery from the AHN Cardiovascular Institute. Most recently, the hospital was recognized by the American Heart Association and American Stroke Association for its high-quality heart failure, atrial fibrillation, coronary artery disease, and stroke care programs.

How to refer:

Call 844-MD-REFER or visit https://www.ahn.org/health-care-professionals/independent-physician-resources.

*Source: Health Disparities in Peripheral Artery Disease: A Scientific Statement From the American Heart Association. National Institutes of Health. NIH.gov

**Source: DETOUR2 trial outcomes demonstrate clinical utility of percutaneous transmural bypass for the treatment of long segment, complex femoropopliteal disease. National Institutes of Health. NIH.gov