New Devices Launched for PAD and CLI Patients
New Devices Launched for PAD and CLI Patients | CIS, Cardiovascular Institute of the South, Dr. Craig Walker, Peripheral Artery Disease, PAD, Louisiana Medical News, Terrebonne General Medical Center

Dr. Craig Walker and patient Frank Lagarde
While working on his Poplarville, Miss. farm, Frank Lagarde started having excruciating pain in his right leg. “It felt like a pulled tendon or ligament in the back of my leg,” he recalled. “I just figured it would go away.”

It didn’t. His doctor referred to him to a cardiovascular surgeon, who diagnosed Lagarde with peripheral artery disease (PAD). “I had no idea whatsoever that I had peripheral artery disease,” he said. “Prior to that, I went to the wellness center three mornings a week, and I was walking several miles and doing exercises and aerobics.” His doctor placed a stent in his right leg before Christmas of 2007.

After a trip to Disney World with his family in February 2008, Lagarde’s pain returned. “It was like a knife sticking in the bottom of my foot, pins and needles and shooting pain,” he recalled. “I couldn’t walk more than 50 or 60 feet before I got a severe charley horse. And, I had an open sore on the bottom of my foot that would not heal.”

To fix the problem this time, his doctor put an artificial artery in his right leg. “I had 100 percent blood flow,” he said. “It was awesome.”

The day after he got out of the hospital, he experienced “the worst pain in the world.” It turned out that he had contracted a form of MRSA staph infection, which kept him in and out of the hospital for almost seven months. He was discharged three days before his daughter’s wedding. “I had promised her I would be there to walk her down the aisle in either a wheelchair or a walker,” he recalled.

Lagarde walked her part-way down the aisle with a walker, then tossed it aside and continued to walk his daughter unassisted. “Everyone started crying,” he recounted. “It was a great experience. I was just glad to do it.”

Eventually, Lagarde’s artificial graft gave out and was removed. Afterwards, he was in constant pain and his leg had turned grayish-yellow. He couldn’t walk for more than 50 feet without severe muscle spasms. Amputation seemed to be the only option.

His cardiovascular surgeon referred him to Dr. Craig Walker, founder, president and medical director of Cardiovascular Institute of the South. At the time he saw Walker, Lagarde’s skin perfusion pressure was about 10 (normal is 70).

Walker treated Lagarde’s precarious condition using a combination of techniques, peripheral intervention, he explained. “It required us to do several things, or his option was to lose the limb. We first used a wire to cross the area of occlusion. Then, we used a laser to vaporize some of the offending plaque. That allowed us to make an appropriate-sized channel with a balloon to restore blood flow. One little tiny part of that channel was occluded, so we stented right on that one area.”

After the surgery, Lagarde’s blood flow was back to nearly normal. “I was ecstatic,” Lagarde said. “The pain had gone away. I could walk without getting charley horses. I could probably walk 600 or 700 yards, which I never could have done several years ago.” 

For Lagarde’s procedure, Walker used a self-expanding stent. In June, he attended the New Cardiovascular Horizons conference in New Orleans, which he co-founded, where two new devices to treat PAD and CLI (critical limb ischemia) – the Epic™ Self Expanding Stent and Truepath™ CTO Device – were unveiled to the approximately 900 attendees. Both products, manufactured by Boston Scientific Corporation, were recently approved by the FDA.

The Epic Vascular Stent System is a self-expanding Nitinol stent designed to open blocked arteries in patients with iliac artery stenosis. “This stent can be placed very accurately, and that’s a nice feature of it,” Walker said. “It’s quite flexible and tends to fit very nicely and not distort the vessel.”

In clinical trials, the Epic system showed a low nine-month major adverse events rate of 3.4 percent – significantly lower than the pre-specified performance goal of 17 percent based on previous outcomes for iliac stenting. “The clinical data was very good in terms of its performance,” Walker confirmed. “The Epic stent tended to stay open very well and to have very good outcomes. It’s a great tool.” 

The Truepath is a crossing tool for chronic total occlusions within the peripheral vasculature. “Inherent in every peripheral vascular procedure or any procedure in the heart, you have to first cross the area of blockage in order to treat that blockage,” Walker explained. “The Truepath tool is designed to let us cross blockages safely.”

This innovative crossing device features a diamond-coated tip which rotates at 13,000 rpm to facilitate drilling through calcified lesions and other tough blockages. “Because of the little drill on the end, it can go through very, very hard stuff very nicely,” Walker explained. “It lets us actually find our way through areas of occlusion. I’ve used it several times when I simply could not cross a blockage, and it was highly effective. ”

The Truepath’s ultra-low 0.018-inch profile is roughly half the size of similar devices. “One thing I like about this is that it’s very low profile – it’s just the size of a wire,” Walker said. “So, if you are working in really small vessels, you don't have to put tubes in to do the work, and you are less likely to occlude a vessel. And, because it is so small, you are less apt to do any harm if by accident it goes astray.” 

Walker is glad to add these new tools to his arsenal for treating peripheral arterial disease. “Just like a carpenter who has to have more than one screwdriver, you need to have a bunch of tools of different sizes and levels to treat PAD and CLI,” he said.

As for Lagarde, he is grateful that Walker salvaged his leg with the use of innovative devices like these. “I thank God, I thank Dr. Walker, I thank the people at Terrebonne General who were the greatest, most friendly people I’ve ever come across in my life, and I thank the staff at the Cardiovascular Institute of the South, who is awesome,” Lagarde said.




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