When a simple walk down the block caused severe leg pain, a South Florida man turned to the experts at Miami Cardiac & Vascular Institute for help. The patient became the first in the region to take part in a clinical trial to bypass extensive blockages in the superficial femoral artery, the longest artery in the leg ― without surgery. He quickly resumed his active lifestyle.
Like millions of Americans, the 67-year-old patient suffered from peripheral artery disease (PAD), caused when plaque builds up in the body’s blood vessels. Blockages can occur anywhere, but are common in the legs, reducing blood flow and causing claudication (walking impairment) and pain. If the disease progresses, it can lead to gangrene and limb amputation.
“This is a new and very exciting non-surgical option for patients with very long blockages in the femoropopliteal artery,” said Ripal Gandhi, M.D., an interventional radiologist who specializes in minimally invasive treatments. “We are hopeful that the study will validate the safety and effectiveness of percutaneous arterial bypass, which is much less invasive than traditional surgery.”
The DETOUR2 trial uses the percutaneous approach, involving a pinhole incision into the femoral artery above the occlusion or blockage. Tiny, metal stents are threaded through the vessel and through a nearby vein before re-entering the femoral artery below the blockage. The overlapping stents create a new channel for blood flow.
Traditional open surgery requires a large incision, the use of an existing vein in the same leg or removal of a blood vessel from another part of the leg to create a bypass, and several days in the hospital. Not all patients have another healthy vessel available for the bypass and a synthetic graft may be necessary in those patients. In addition, the procedure carries a risk of infection and other complications, as well as extended time for recovery.
The Institute’s first DETOUR2 patient stayed in the hospital overnight, though the procedure can be performed as same-day outpatient treatment. Because the procedure is minimally invasive with no large incisions, it may be an option for those too sick to undergo an open surgery.
“At Miami Cardiac & Vascular Institute, we’re on the forefront of clinical research, which means that we’re able to offer patients options that are not available other places,” Dr. Gandhi said. The Institute gained national and international recognition after pioneering the use of stents throughout the body in the late 1980s and early 1990s. Joining Dr. Gandhi in performing these procedures are Institute physicians Barry Katzen, M.D., Alex Powell, M.D., James Benenati, M.D., Constantino Peña, M.D., and Brian Schiro, M.D.
And while the COVID-19 pandemic put a brief pause on clinical trials at the Institute, studies resumed safely with special precautions in place.
“The DETOUR2 technology is intriguing and the approach very innovative. Completely bypassing the artery and going into the vein is an ingenious idea,” Dr. Gandhi said. The true test of the DETOUR2 study involves analyzing the length of time a blood vessel remains open. After traditional surgery, 75 to 80 percent of vessels are still open one year after surgery. “We would like to match or surpass that,” Dr. Gandhi added.
To prevent PAD, doctors recommend avoiding tobacco, exercising, maintaining a healthy weight or losing weight if overweight, as well as controlling blood pressure and cholesterol. People with diabetes and heart disease are at higher risk for PAD.
For more information on the DETOUR2 trial, email MCVIResearch@BaptistHealth.net.