Piedmont Heart Institute is participating in a new clinical trial investigating a novel treatment option for those suffering from an advanced form of coronary artery disease (CAD) in which the plaque blockage also includes the presence of calcium. Interventional cardiologist Andrew J. Klein, M.D., is serving as local principal investigator for the study.
Intravascular Lithotripsy (IVL) is an innovative technology that generates sonic pressure waves – also known as shockwaves – designed to break up problematic calcium so that the artery can be opened and blood flow restored with the placement of a stent. The therapy leverages a similar minimally invasive approach that has been embraced by physicians for decades to treat kidney stones, which are also made up of calcium.
“We are thrilled to be among the first hospitals in the United States to investigate this innovative technology for the potential benefits of patients in Georgia,” Dr. Klein said. “Hardened calcium within the heart is becoming more common as people are living longer and is very challenging to treat. If the sonic pressure waves produced when performing Intravascular Lithotripsy can break up the calcium in a safe and effective manner, then this technology could be a game changer for how we treat advanced coronary artery disease.”
Calcium slowly develops and progresses to its hardened, bone-like state in the heart’s arteries 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 balloon therapy techniques used in traditional angioplasty 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.
The DISRUPT CAD III study is designed to enroll 392 patients at 50 hospitals worldwide and follow the patients for up to two years. Shockwave C2 Coronary IVL catheters are commercially available for the treatment of de novo coronary artery disease in Europe and other select geographies; they are limited to investigational use in the United States.