Peripheral artery disease (PAD) is a build-up of plaque in the walls of the arteries, blocking the flow of blood to the limbs, most commonly the legs. This vascular disease affects as many as 800,000 Canadians and people with diabetes are two to four times more likely to be affected. Even with treatment, 40 per cent of people with severe PAD face major amputation. In Ontario alone, more than 2,000 leg amputations are performed each year.
Project Saving Legs is a project, rather than a single procedure, to raise awareness and to invent and offer the most advanced treatments to eliminate amputations, and to educate and train a new generation in these advanced techniques. The project is an initiative led by Vascular Surgeons at Sunnybrook Health Sciences Centre, with an aim to open a clinic specializing in saving legs through treating diabetic foot ulcers. By promoting early detection and diagnosis of wounds, and aggressive treatments, Sunnybrook's mission is to reduce amputation rates from 40 to five per cent.
In Canada, anyone with diabetes has a 15 to 25 per cent risk of developing a foot ulcer. When a patient with diabetes develops a foot ulcer, their chance of dying in the next two years is 50 per cent; and their chance of having an amputation in next two to five years is over 75 per cent. The day that a patient develops a foot ulcer is actually a worse outcome than a day when a patient is diagnosed with breast cancer, prostate cancer, or colon cancer combined. "If you are a diabetic and with a foot ulcer where the blood flow below the knee is affected, which is typically the case, you would inevitably need an amputation, but that has now changed," says Dr. Giuseppe Papia, Vascular & Endovascular Surgeon.
Sunnybrook's vascular and wound care experts are working concurrently, using the toe and flow model to increase blood flow to the area, to benefit patients who develop a foot ulcer. By using the latest skills and equipment, patients can be treated quickly and in a multidisciplinary fashion.
Dr. Papia, and his colleague Dr. Andrew Dueck, perform some 250 procedures annually using a minimally invasive angioplasty to clear blockages and restore blood flow to patients' legs. The procedure involves sending a balloon catheter through tiny arteries in the leg to open blood vessels leading to the foot. Patients often experience immediate relief from pain and typically return home the same day.
"Sunnybrook is one of the first medical centers in Canada to treat vascular disease with angioplasty balloons that are covered in an anti-inflammatory drug," says Dr. Papia. "To angioplasty the artery open is not enough, it will scar back down. The drug minimizes scar tissue formation, which can lead to blockage of the artery. When you use an anti-inflammatory drug and deliver it to the actual spot that you need it, it will make a difference over the long-term."
Sunnybrook is very unique in Canada, in that vascular surgery, cardiac surgery and cardiology are combined as one program. As a result, the procedure is done is a dedicated Cath Lab, rather than a radiology suite or an operating room with hybrid equipment.
In 2008, Dr. Papia began looking at alternate treatments for vascular disease. While doing a fellowship in endovascular surgery at the Cleveland Clinic, he worked with a mentor to learn how to do the angioplasty procedure. At that time, coronary technologies and wires used in the heart were used; they did not have the right equipment and had to make the wires longer and put them together to perform the vascular procedure.
Dr. Papia then learned that this type of procedure was being done in Europe and subsequently did site visits and worked with physicians there. During those site visits, he was inspired by the diabetic foot hospitals that are dedicated to aggressive and early treatment for patients with vascular problems. He found the centers in Europe incredibly organized. "They function much like a cancer center, but for diabetic foot problems," says Dr. Papia. "The patient shows up and has everything done from diagnostics to multidisciplinary visits -- medical, surgical, podiatry and wound care are all in one spot. Amputation rates are extremely low and the quality of life rates for these patients are extremely high; overall their outcomes are great."
With increasing age and obesity, diabetic rates are exploding not only in the Western world, but globally. Dr. Papia says that not only is it an epidemic, but there is a tsunami coming to our health system because of this problem. Data from the Ontario government indicates that if you have a foot ulcer and are a diabetic, to treat that ulcer will cost about $6,000 to $9,000. If you have an infected foot ulcer, antibiotics and medical costs bring the cost closer to $12,000 to 13,000. If you end up having a leg amputation, the cost to the health system is closer to $65,000 to $70,000 for the same patient. "There is a tenfold increase in cost if we don't prevent these ulcers and treat them early," says Dr. Papia.
"Looking forward, we have the potential to benefit patients and make a huge impact on their quality of life," says Dr. Papia. "If I had to pick an area in healthcare 2030 that would address this colossal problem, this would be one of them. It makes sense that if you have this problem that we know is very costly, and has an outcome or diagnosis that is worse than many cancers, without a dedicated center we are going to have a hard time making a difference."
Dr. Papia says if you look at cancer centers for example, or trauma centers, you can't have just one. You need them everywhere if you are going to make a difference. His vision is to take this grassroots initiative provincially and nationally as a campaign for awareness, education, research and ultimately treatment.
Project Saving Legs has a Twitter feed and Facebook page to help spread the word and build momentum. Tweet using #SavingLegs, or visit https://www.facebook.com/projectsavinglegs/?fref=ts.
For more information, contact Giuseppe.Papia@sunnybrook.ca
How the angioplasty procedure works:
- After undergoing ultrasound tests (that detail blood flow and reveal narrowed arteries or blockages), a physical exam and sometimes a CT scan in the clinic, patients head to the catheterization lab for an angioplasty procedure.
- If the patient requires it, some mild sedation may be offered. X-rays of the groin area are then taken to determine the safest point of entry to the patient's femoral artery.
- After administering a local anesthetic, a small needle puncture will be made in the groin on the side opposite the problem leg. (For a right foot ulcer, Dr. Papia prefers to access the femoral artery from the left side of a patient's groin, a technique that offers him the most manoeuvrability down the blood vessel and offers the best picture of what's happening from the aorta all the way down the leg.)
- The artery is then punctured with a needle, and a catheter is fed up and over the middle of the femoral artery, down into the opposite leg. (This is all visible on the X-ray monitor mounted next to the operating table.) A coronary wire is fed through the catheter. Dye is injected through the catheter, allowing the surgeon to see the blood flow and vessels via moving X-ray pictures (fluoroscopy).
- A blood thinner is administered (catheters can sometimes block blood flow and start clotting in the artery); then the wire of choice is fed through the catheter down to the target area. The wire is used to clear the blockage, and then a tiny balloon is slid down to the site of the angioplasty. Using a small hand pump, the surgeon inflates the balloon inside the artery, leaving it in place for three minutes or so, opening up blood flow through the vessel.
- The balloon, wire and catheter are removed from the patient, and the wound is closed with a closure device. Patients go home four hours post-procedure and return for a diagnostic checkup in a month's time.