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Research in the Journal of the American College of Cardiology Shows Potential for ‘Shockwaves’ to Safely Break Up Calcified Plaque Prior to Stenting

New research conducted at Deborah Heart and Lung Center was recently published in the Journal of the American College of Cardiology (JACC) showing that patients with an advanced form of coronary artery disease (CAD) benefited from an investigational treatment that used sonic pressure waves to break up hardened blockages in the heart. The novel therapy — not yet available to the general public — is similar to the therapy used to break up kidney stones, and is known as Intravascular Lithotripsy (or IVL). It is currently being reviewed by the U.S. FDA for potential pre-market approval 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 at Deborah access to this potential therapy as part of this important study,” said principal investigator and Deborah cardiac interventionist Daniel Ice, MD. “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. If all goes well with the FDA, we will hopefully soon be able to offer this treatment to many more patients.”

Dr. Ice, along with sub-investigators Richard Kovach, MD; Kintur Sanghvi, MD; and Vincent Varghese, DO, were the key Deborah team on the Disrupt CAB III study which 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.

Shockwave C² Coronary IVL catheters are limited to investigational use in the United States by the FDA.

About Calcified Coronary Artery Disease

Calcium slowly develops and progresses to its hardened, bone-like state over the course of several decades of cellular growth and death in diseased plaque within the heart arteries. While it is slow to develop, its impact is immediately encountered when performing procedures in calcified lesions. The calcium’s hardened structure restricts normal artery movement and makes the rigid arterial tissue resistant to traditional balloon therapies that have been designed to compress the plaque within the artery wall to restore normal blood flow. For these reasons, the presence of calcium increases the complexity of most cases and decreases the effectiveness of most treatments.

How Intravascular Lithotripsy (IVL) Works

Intravascular Lithotripsy uses a small generator to produce therapeutic sonic pressure waves from a catheter that is threaded through the arterial system to the site of the heart blockage. The pressure waves pass through the soft arterial tissue, preferentially disrupting the hardened calcified plaque inside the arterial wall by creating a series of micro-fractures. After the calcium has been modified, the artery can be expanded using a low-pressure balloon and a stent, thereby enabling even historically challenging CAD patients to be treated effectively with minimal injury to the artery. For an animation of the procedure, visit www.intravascularlithotripsy.com.

For study and site information NIH Clinical Trials.