Evidence shows a strong correlation between Type II Diabetes and diseases of the vascular system. In the surgical realm the effects of these diseases are alarming, as 10 to 25 percent of U.S. adults over 55 years of age currently suffer from Peripheral Artery Disease (PAD). While many are asymptomatic, with only 25 percent seeking treatment, another 750,000 suffer Diabetic Foot Ulcers, and up to 25 percent of these patients eventually require an amputation. This is in addition to experiencing a reduced quality of life and consuming a great deal of healthcare resources.
In the U.S., over 150,000 lower extremity amputations (LEA) are carried out annually, resulting in $1.1 billion in healthcare costs per year. For diabetics, the risk of LEA increases eight-fold once an ulcer develops. Two years following trans-tibial amputation, more than one-third of these patients die. This increased risk of amputation and the associated dangers make introduction and adoption of preventative programs increasingly important.
Revascularization, Not Amputation
Noticing the high incidence of symptomatic and asymptomatic Peripheral Vascular Disease (PVD) associated with coronary artery disease, David Allie, MD, of the Louisiana Cardiovascular and Limb Salvage Center in Lafayette, LA, pioneered an approach to begin treating PVD with endovascular techniques.
Using a ‘Head to Toe’ approach, Dr. Allie and his team work with the latest medical technology and products to perform ‘Infra-Pedal Revascularization’ (IPR) to revascularize patients below the knee.
When a bypass graft fails, it often results in 100 percent occlusion of the graft. Dr. Allie and his team use laser therapy to clear this blockage. Using a device with a different wavelength, Dr. Allie inserts a balloon called the ‘PolarCath’ that works at temperatures below 10 degrees to open the vessel. Then, using a super-oxidized solution to clean the surgical field, he is able to remove bacteria and microbes without performing aggressive debridement.
Dr. Allie has also borrowed techniques from cardiologists to treat smaller vessels and arteries of the lower extremities. A special ultra-sonic wire called a ‘CROSSER wire’ can be used to penetrate and open a blocked vessel, revascularizing the patient’s foot the same way a cardiologist would revascularize the heart.
Furthermore, Dr. Allie has begun using stents on his patients to hold the lumen of the vessel open after surgery. Small stents are able to go into small lumens below the knee. When a vessel is calcified, Dr. Allie uses the Diamondback, an orbital atherectomy device, to sand the calcium and break particles down to 0.7 microns—as small as a red blood cell—and absorbs into the reticular endothelial system.
Interventional Wound Care
Dr. Allie is still working to perfect the revascularization procedure, and therefore, still performs bypass graft procedures. Here, he and his team have found the challenge to be in healing the surgical wound, and advocates aggressive debridement of the wound site with a super-oxidized solution. He adheres to the principle of removing as much necrotic tissue as possible and creating a wound bed free of infection.
Even when aggressive debridement is performed, wound healing is fraught with potential problems. Both traditional wound care and advanced wound care have failed to provide a solution to get the wound to heal in certain patients. As much as 20 percent of wounds experience complications due to patients having edema, diabetes and other morbidities that are often seen as barriers to wound healing.
In surgical bypass procedures, 10 to 20 percent of the surgically-created wounds will dehisce or fail to heal properly due to factors that include:
- Poor skin healing properties in elderly diabetic patients.
- Edema in the tissues due to surgical trauma.
- Complex dissections of deep tissues in the lower leg that were needed to perform the limb salvage bypass.
Furthermore, there are the issues surrounding multiple dressing changes over a period of many months.
Using a device called DermaClose from Wound Care Technologies, Dr. Allie has created what he terms ‘Interventional Wound Care’ to intervene in the wound healing process. The device closes wounds by applying continuous tension to the wound edges. In a recent study of 25 cases, use of DermaClose demonstrated an 86.9 percent reduction in wound surface area over three days. For Dr. Allie, this allows time to suture the wound edges together free of tension and allow the wound healing process to progress with the device still in place.
Often, Dr. Allie will prophylactically place a DermaClose tissue expander on complex incisional wounds 30 minutes before final wound edge closure in order to facilitate primary closure, and then leave the device on the wound for three to seven days. This approach, he has found, decreases his wound dehiscence rate, facilitates wound healing and allows for earlier ambulation and return to normal activity.
While it continues to be a global problem, Dr. Allie and his team have proven that amputation—and the terrible consequences associated with it—can be avoided.
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