Mar 2, 2020
Critical Limb Ischemia: Reducing the Amputation Rate

By Dr. JD Meler, VP, Clinical and Medical Affairs

Peripheral Artery Disease (PAD) is a common, yet serious circulatory disease impacting nearly 20 million people in the United States. PAD is caused by atherosclerosis or the hardening and narrowing of the arteries, which restricts blood flow to the arms, legs and feet.1 This disease is associated with an increased risk for cardiovascular complications such as heart attack, stroke and coronary heart disease. Critical Limb Ischemia (CLI), the most advanced form of PAD, affects an estimated 3.4 million Americans,2 and is associated with amputations and high mortality rates, if left untreated.

There are many risk factors for PAD including age, family history, diabetes, kidney disease, high blood pressure, high cholesterol, tobacco use and ethnicity. Risk factors, like high blood pressure and high cholesterol, can be managed through lifestyle choices by following a healthy diet and managing diabetes. Other PAD risk factors, like family history and age, are out of a patient’s control.3 Untreated PAD can lead to CLI or other serious complications, including amputation.

When it comes to treating PAD and CLI, there are several treatment options available. Depending on the condition of a patient’s PAD symptoms, treatment options may vary greatly and can be managed through medications to help reduce cholesterol, lower blood pressure, manage diabetes or help to stop smoking. Endovascular treatments are another one of the options available for treating PAD. An endovascular treatment is completed in an operating room or a catheterization lab. Unlike surgery, endovascular treatments only require a small incision, often in the groin, arm or leg. A physician will then pass a series of devices through the incision and into the artery, in order to reach the site of the blockage. The devices and techniques that work to help open the artery and keep it open include angioplasty, drug coated balloons, stenting and atherectomy. For those who can’t be treated by medication or endovascular treatments, there are surgical options available. These procedures typically require general anesthesia due to incisions in the limbs. Generally, a surgeon will assess the risks and benefits prior to the procedure to ensure the best possible outcome following the operation.

Surprisingly, the vast majority – 60-71% – of CLI patients in the U.S. undergo amputations without ever receiving any vascular intervention. It is estimated that there are 99,900 amputations per year due to vascular disease. Patients with CLI have been reported to have a major amputation rate as high as 40% at six months and a mortality rate of 20-25% in the first year after presentation. Around 27% of CLI patients with an amputation will require another amputation within a year.4 Over a five-year period, mortality rates for patients with an amputation have been estimated to be between 50 and 74 percent.5 Not only do amputations significantly affect patients' mobility and quality of life, but they often lead to further complications. As a clinician, this is extremely concerning, and more treatment options are urgently needed to avoid amputations.

In order to avoid amputations and prevent PAD from progressing to CLI, it’s important to diagnose and address symptoms early. Oftentimes, patients won’t have PAD symptoms at all. When symptoms do present, they can be overlooked, confused for other physical challenges or mistaken for part of the normal aging process. Early symptoms include painful leg cramping, leg numbness, weakness or heaviness in limbs, and burning sensations or aching in the feet. More severe symptoms can present with resting leg pain and cold, dry or discolored skin on feet or toes. At this stage, legs or feet may develop painful sores, ulcers and/or gangrene due to lack of oxygen. The pain may be severe and can last for hours—even while at rest.6

It’s clear that there is more work to be done to help clinicians treat CLI and reduce the overall burden on the health care system. BD is committed to developing and providing medical technologies that address this serious unmet need and ultimately help people living with PAD/CLI. We will continue to discuss benefits of PAD awareness, education and early interventions with patients and providers about disease risks and treatment options. Learn more about BD’s PAD Awareness Campaign at


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