Tick Tock This is a Block We Must Find a Way to Stop

Patients with Chronic Total Occlusion (CTO) of the coronary artery have lesions that create a total blockage in the heart artery—and for most, ultimately become an impediment to normal activities. Why?  Of the millions of patients, a year living with coronary artery disease, 100,000 to 200,000 patients a year are provided medication therapy--leaving their underlying lesion unaddressed.

Jim is a great example. He saw his physician because of chest pressure and shortness of breath. He was given a battery of stress tests. An angiogram revealed CTO. Because of the risk and difficulty in surgically treating the lesion, he was told medication therapy was his best option. Although he proceeded with medication, Jim, like most, continued to experience symptoms and ultimately became less active. Over time the reduced activity made him asymptomatic, so he presumed he was getting better. The reality was different. His heart muscle was working well enough to keep him alive, but he wasn’t getting better. The untreated lesion remained a ticking time bomb.

“These are the hardest lesion subsets to treat in cardiology,” says Dr. William Lombardi, an associate clinical professor of medicine in the Division of Cardiology, and the director for Complex Coronary Artery Disease Therapies in the UW Medicine Regional Heart Center. Lombardi should know. He is considered a world expert on Chronic Total Occlusion Percutaneous Coronary Intervention (CTO PCI)—and is informally referred to as “the godfather of CTO PCI”, in part because he treats patients worldwide and has done more of these procedures than anyone else in the U.S. In fact, Dr. Lombardi’s entire clinical practice was built on treating patients with coronary artery disease that have been told, “nothing more can be done”.

Dr. Lombardi explains the challenges of CTO this way: “CTO falls into a treatment paradox exacerbated by a multitude of factors, the foremost being technical complexity coupled with the lack of physician experience in percutaneously treating these lesions. This severely reduces the ranks of interventional cardiologist willing and able to provide treatment options.”

As sad as these facts are, they are somewhat understandable considering the amount of training, skill, and experience required to remove CTO lesions. Today the surgery creates anatomical ambiguity because surgeons use a two-dimensional screen to circumnavigate a three-dimensional artery. Worse, there are potentially lethal blind spots physicians encounter as they attempt to cross and treat a lesion between 1-10 cm long. Dr. Lombardi likens the experience to mining. “Imagine crawling through a mine and not being able to see where the wall or edge is—and knowing that if you touch it, the mine collapses, and causes death”.

So, what can be done to help more patients receive potentially life-saving surgical interventions that only a few physicians like Dr. Lombardi are able and willing to do?

The answer, according to Dr. Lombardi, is crystal clear: “If you can turn the lights in the artery on and provide a three-dimensional view, you can see where you are going vs. walking blindly in the dark. This reduces the guess work and visual challenges, making the procedure much less scary and more straightforward.”

And that is precisely what VerAvanti is attempting to do with the Scanning Fiber Endoscope (SFE). When asked about the potential for the SFE, Dr. Lombardi said, “It could be a real game changer because it has the potential to make the procedure safer, faster and more adoptable—in other words, instead of having a golf course for only 200 PGA tour pros, we could have a golf course that anyone in the community can play.”