New research conducted at Bryn Mawr Hospital, part of Main Line Health’s Lankenau Heart Institute, showed that patients with advanced coronary artery disease (CAD) benefited from an investigational treatment that uses sonic pressure waves to break up hardened blockages in the heart.
The research, recently published in the Journal of the American College of Cardiology, was part of the Disrupt CAD III study, which sought to evaluate the safety and effectiveness of using a technique called intravascular lithotripsy to break up calcified plaque prior to stenting.
Intravascular lithotripsy (IVL) uses a small generator called the Shockwave to produce sonic pressure waves from a catheter that is threaded through the arterial system to the site of the heart blockage. These pressure waves then pass through the soft arterial tissue, creating a series of micro-fractures that disrupt hardened calcified plaque. The technique is similar to the one used to break up kidney stones.
After the calcium has been broken up, the artery can be expanded using a low-pressure balloon and a stent, thereby enabling even historically challenging CAD cases to be treated effectively with minimal injury to the artery.
“We were thrilled to be among the first centers in the United States to offer our study patients in the Philadelphia region access to this potential therapy as part of this important study,” said Sarang Mangalmurti, MD, an cardiologist and vascular specialist at Bryn Mawr Hospital. Dr. Mangalmurti was the first physician in the Philadelphia area to use a Shockwave IVL device in heart procedures in 2019.
Approximately 18 million adults 20 and older have coronary artery disease, making it the most commonly diagnosed type of heart disease in America. CAD can occur when the blood vessels that carry oxygen, blood and other nutrients to your heart are damaged as a result of inflammation or plaque buildup in your arteries. As people with CAD grow older and their disease progresses, plaque in the arterial wall evolves into calcium deposits, which narrow the artery. This makes the artery rigid and more difficult to treat with current treatments, which can sometimes result in complications for patients.
“Hardened calcium within the heart is becoming more common as people are living longer and is very challenging to treat. As a result of this research, 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. Pending approval from the FDA, we are hopeful that we will soon be able to offer this treatment to many more patients,” says Dr. Mangalmurti.
The Disrupt CAD III study enrolled 384 patients at 47 sites in the United States, France, Germany, and the United Kingdom—including Bryn Mawr Hospital. The study demonstrated 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 typically found with other technologies.
Shockwave C2 Coronary IVL catheters are limited to investigational use in the United States by the FDA. Learn more about the Disrupt CAD III trial.