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

By Jen Christensen and Janelle Chavez, CNN

Cynthia Elford loves to travel and hike, but a few years ago, her Type 1 diabetes made getting around nearly impossible. By 2018, the Pennsylvania grandmother faced the possibility of losing her right leg because of a diabetes-related circulation problem, and she developed sores on her toes that kept getting worse.

She pleaded with her doctor to try to save her right leg. She had already lost the left leg to the same circulation problems.

“I told him I didn’t think that I’d be able to make it if I lost my other leg,” said Elford, 63. “I was too active of a person.”

Dr. Mehdi H. Shishehbor, president of University Hospitals Harrington Heart & Vascular Institute in Cleveland, told her that she might be in luck.

People with extreme circulatory problems like Elford have typically been considered “no-option” patients, destined to lose their foot or leg. But University Hospitals Harrington Heart & Vascular Institute had joined a clinical trial that might be able to help her.

Elford didn’t hesitate to say yes to the trial, even when Shishehbor warned her that it would involve a lot of pain, at least at first.

Elford became the first person in Ohio to undergo the new procedure, called LimFlow.

Shishehbor has been perfecting LimFlow for the past five years or so, he said. He helped test it in a small number of people to make sure the technique was feasible and safe. Doctors then expanded the research to a multicenter trial with 105 participants. The results were published Wednesday in the New England Journal of Medicine.

LimFlow is a minimally invasive technique that can help people with the extreme form of peripheral artery disease called chronic limb-threatening ischemia, or CLTI.

With peripheral artery disease or PAD, a fatty sticky substance called plaque accumulates on the inner surface of the arteries that lead to the legs. This causes the blood vessels to narrow and reduces circulation to the legs and feet.

Without an adequate supply of blood to the area, wounds and ulcers are slow to heal or won’t heal at all, and that can damage tissue. Infection can spread to the bones. A lack of bloodflow can also result in gangrene.

CLTI carries a high mortality rate: About 25% of people don’t survive one year after diagnosis, studies show.

For some, blockages can be cleared through a surgical procedure, and circulation can be restored. But in 20% to 30% of cases, that standard care doesn’t work, Shishehbor said. The blockages cannot be cleared, and amputation has been the only option.

With the LimFlow procedure, doctors take an artery ahead of the blockage and connect it to an unblocked vein in the lower leg using a stent graft, a small kind of mesh tube, reversing the flow in that vein to send blood to the foot.

It’s an outpatient procedure done under the same kind of sedation that doctors use for a colonoscopy, so there’s no general anesthesia. It’s all done with needles, one in the groin and another in the foot, and catheterization, the use of a flexible tube, Shishehbor said.

The procedure was performed successfully in all but one of the 105 study participants.

The study was designed with a median participant age of 70. More than 30% of the participants were female, and 43% were Black, Hispanic or Latino. Diversity was key, the study authors said, because people of color with PAD are disproportionately at risk of amputation compared with White patients, studies show.

Six months after the procedure, 76% of the participants had still been able to keep their leg; 76% had completely healed, or their wounds were healing.

“It’s been incredible,” Shishehbor said. When he started with the trial, he thought that preventing amputation in even 20% of patients would be successful. “I’d be happy, because the alternative would be 100% amputation. So the fact that we were able to, in 76% of the time, save the limb of the patients that had no options, it made me very proud and very happy and excited.

“We feel that we are going to give hope to so many patients,” Shishebor added.

Dr. Christopher Abularrage, a vascular surgeon at Johns Hopkins Medicine, said the patient population targeted in the study had previously had no option but amputation.

“This new technique provides vascular surgeons and also other interventionalists further options to decrease major amputations and improve amputation-free survival,” said Abularrage, who was not involved in the new research.

The minimally invasive aspect of the procedure is also an advantage, he said, because this group often has multiple other health conditions.

“It’s minimally invasive in this sick population versus what could be a three-, four-hour open surgery with large wounds, blood loss, cardiac risk,” Abularrage said. “I think that this is going to expand the use of this technique for years to come for those people who, unfortunately, don’t have options for a bypass.”

Dr. Michael Conte, a vascular surgeon at UCSF, takes a more cautious tack because there was no control group in the trial, and he doesn’t feel that it was completely clear that it worked.

“Half the patients at the end of the study still had open wounds. Fifty percent to 60% still needed other procedures. The story was far from over when the study ended for most of these patients,” said Conte, who was not involved in the study.

He’s also concerned that because it’s an innovative procedure, some providers may choose it instead of a more reliable conventional approach, even for people who have other options like surgery. But for people without alternatives, he said, it could be an option.

“I think the vascular community needs to interpret this with some excitement, but cautious excitement,” Conte said.

The trial data has been submitted to the US Food and Drug Administration, Shishehbor said, and the researchers hope to hear by May whether LimFlow will be approved.

A lot of people stand to benefit if it’s approved. In the US alone, about 160,000 people are diagnosed with this “no-option” form of the circulatory disease every year, one study showed.

And the number will probably grow as the number of people with diabetes — a known risk factor — continues to rise. About 6.5 million people 40 and older in the United States have PAD, according to the US Centers for Disease Control and Prevention. Smoking, high blood pressure, high cholesterol and being older than 60 are also risk factors.

Lower limb amputations are 10 times more likely in people who have diabetes than those who don’t, according to the World Health Organization.

For Elford, the procedure offered an immediate sense of hope.

“I was way groggy and out of it, but I remember they all stood around clapping when the procedure was over,” she said.

There was intense pain, at least at first, she said. Shishehbor said it takes about four to six weeks for the body to find its equilibrium and restart the process of healing.

“It was horrible pain, and I can see why a lot of people might give up,” Elford said. “Eventually, the pain started lessening, and it was getting better, and it was just amazing how then I have no pain in my leg whatsoever, and it’s very strong.”

Shishehbor said some of his patients are five or six years past the procedure and are still are doing well. One of them is Elford, who said she is eternally grateful to her doctor.

“I’m walking. I go shopping. I drive,” Elford said. “Yeah, he’s my miracle.”

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