Atlanta (April 19, 2021) – New research conducted at Piedmont Atlanta Hospital recently published in the Journal of the American College of Cardiology (JACC) showed that patients with an advanced form of coronary artery disease (CAD) benefited from a newly approved treatment that used sonic pressure waves to break up hardened blockages in the heart. The novel therapy is similar to the therapy used to break up kidney stones, and is known as Intravascular Lithotripsy (or IVL). It was approved in February by the U.S. FDA in the United States under a “Breakthrough” designation.
As people with CAD grow older and their disease progresses, plaque in the arterial wall evolves into calcium deposits, which narrow the artery. These bone-like structures make the artery rigid and more difficult to treat with current treatments, which can sometimes result in complications for patients. IVL is an innovative technology that generates sonic pressure waves – or shockwaves – on a conventional balloon catheter to fracture the problematic calcium so that the artery can be expanded, and blood flow restored with the placement of a stent.
“We were thrilled to be among the first centers in the United States to offer our study patients in Georgia and throughout the Southeast access to this potential therapy as part of this important study,” said Andrew J. Klein, M.D., an interventional cardiologist with Piedmont Heart Institute. “Hardened calcium within the heart is becoming more common as people are living longer and is very challenging to treat. From the new research just published we now know that sonic pressure waves can modify the calcium in a predictable and safe manner and potentially help patients avoid unnecessary complications of previous treatments.”
The Disrupt CAD III study enrolled 384 patients at 47 sites in the United States, France, Germany, and the United Kingdom. The study met both the safety and effectiveness endpoints, and had high procedural success and few adverse events. With high procedural success, investigators were able to modify the calcium and expand the artery sufficiently to restore blood flow. This was complemented with a low rate of major adverse cardiac events, meaning there was limited damage to the heart muscle or need for a repeat procedure. The study also found a very low risk of complications that can be found with other technologies.