A new procedure offers hope to ‘no option' patients facing amputation because of severe circulation problems

CNN

Cynthia Elford is a traveler and hiker who loves to explore the world, but her Type 1 Diabetes made it nearly impossible for her to get around a few short years ago. In 2018, the Pennsylvania grandmother was facing the loss of her right leg due to a circulation issue caused by diabetes. She also developed sores in her toes, which kept getting worse.

She begged her doctor to save her leg. She lost her left leg due to the same circulatory problems.

Elford, aged 63, said: 'I told my doctor that I did not think I would be able make it without the other leg.' I was a very active person.

The LimFlow Technology Animation

Dr. Mehdi H. Shishehbor told her she could be in luck.

People with severe circulatory problems, like Elford, are often considered "no-option" patients and are destined to lose a foot or limb. University Hospitals Harrington Heart & Vascular Institute joined a trial that could help Elford.

Elford did not hesitate to accept the trial even after Shishehbor warned that she would suffer a great deal, at least initially.

Elford is the first person to have undergone the LimFlow procedure in Ohio.

Shishehbor said that he has been working on LimFlow for about five years. He tested it on a few people to ensure that the technique was safe and feasible. The doctors then extended the research into a multicenter study with 105 participants. The results of the study were published in Wednesday's New England Journal of Medicine.

LimFlow is an minimally-invasive technique that helps people who have a severe form of peripheral arterial disease, called chronic limb threatening ischemia (CLTI).

In peripheral artery diseases, or PAD for short, a sticky fatty substance called plaque builds up on the inner surface arteries leading to the legs. The blood vessels narrow, reducing circulation in the legs and toes.

Wounds and ulcers heal slowly or not at all if there isn't enough blood in the area. This can cause tissue damage. The infection can spread into the bones. Gangrene can also be caused by a lack of blood flow.

Studies show that CLTI has a high mortality: about 25% of patients do not survive a year after their diagnosis.

Some blockages can be removed surgically and circulation restored. Shishehbor says that in 20 to 30 percent of cases the standard treatment does not work. Shishehbor said that the blockages could not be cleared and an amputation was the only solution.

The LimFlow procedure involves connecting an artery in front of the blockage to a vein that is unblocked in the lower leg with a stent-graft. This small mesh tube reverses the blood flow to the foot.

This is an outpatient procedure that uses the same type of sedation as doctors use during a colonoscopy. There's therefore no need for general anesthesia. Shishehbor explained that the procedure is done using needles in both the groin area and the foot. Catheterization, which involves a flexible tube and catheterization are also used.

All but one participant in the study underwent the procedure successfully.

The study was designed to have a 70-year-old participant as the median age. Over 30% of participants were women, while 43% were Black or Hispanic. The study authors stressed the importance of diversity, as people of color who have PAD are at a disproportionately higher risk of having their legs amputated than White patients.

Seventy-six percent of participants were still able to use their leg six months after the surgery.

Shishehbor stated, "It has been amazing." He thought that even preventing amputations in 20% of patients was a success when he began the trial. I'd be happy because the alternative was 100% amputation. The fact that 76% of patients with no other options were able save their limbs made me proud, happy, and excited.

Shishebor continued, 'We believe that we will give hope to many patients'.

Dr. Christopher Abularrage is a vascular surgery at Johns Hopkins Medicine. He said that the patients targeted by the study previously had no other option than amputation.

Abularrage said that the new technique gives vascular surgeons, as well as other interventionalists, more options to reduce major amputations, and improve amputation free survival.

He said that the minimally invasive nature of this procedure is an added benefit, as many people in this group have multiple health problems.

Abularrage stated that the surgery is minimally invasive compared to a four-hour, open procedure with large wounds and cardiac risks. I think this will expand the use of this method for many years for those who don't have the option for a bypass.

Dr. Michael Conte is a vascular surgery at UCSF. He takes a cautious approach because the trial did not include a control group and he does not believe that it was clear whether it worked.

"Half of the patients still had open sores at the end the study." 50-60% of patients still required other procedures. Most of these patients still needed other procedures after the study was completed, said Conte who was not part of the study.

He is also worried that, because this procedure is innovative, some providers will choose it over a more reliable, conventional approach even for those who have other options, like surgery. He said that for those who have no other options, this could be an alternative.

Conte stated that the vascular community should interpret this information with a cautious, yet excited, excitement.

Shishehbor stated that the trial data had been submitted to US Food and Drug Administration and researchers expect to hear back by May if LimFlow is approved.

Many people will benefit from its approval. One study found that in the US, around 160,000 people are affected by this circulatory disease.

The number will likely increase as diabetes, a known factor in PAD, continues to rise. According to the US Centers for Disease Control and Prevention, 6.5 million Americans aged 40 and over have PAD. Risk factors include smoking, high blood cholesterol, and high blood pressure.

According to the World Health Organization, people with diabetes are 10 times as likely to have lower limb amputations than those without.

Elford felt immediate hope after the procedure.

She said, "I was groggy, and I was out of it. But, I remember that they stood around and clapped when the procedure ended."

She said that there was initially intense pain. Shishehbor says it takes the body four to six weeks to regain equilibrium and begin the healing process.

Elford described the pain as 'horrible'. Elford said that the pain began to lessen and was improving. It was amazing when I had no pain at all in my leg.

Shishehbor stated that some of his former patients have been doing well for five to six years after the procedure. Elford is one of those patients who is grateful for her doctor.

Elford replied, 'I drive. "Yeah. He's my miracle."