First in Pennsylvania to enroll patient in disrupt CAD III clinical trial investigating potential of novel Shockwave technology to break up problematic calcium in heart arteries
Bryn Mawr Hospital, part of Main Line Health’s Lankenau Heart Institute, is the first in the region to participate 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. 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 the first in the state of Pennsylvania to offer this innovative technology,” says Sarang Mangalmurti, MD, Lankenau Heart Institute interventional cardiologist at Bryn Mawr Hospital, who performed the hospital’s first procedure. “Hardened calcium within the heart is becoming more common as people are living longer and is very challenging to treat. The sonic pressure waves produced when performing Intravascular Lithotripsy give us a novel treatment option to weaken the calcified plaque, with potentially less risk of trauma to the artery compared to other treatments.”
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 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.
Bryn Mawr Hospital was also the first in the region to offer Shockwave Medical’s Lithoplasty System to treat calcified leg artery blockages with lithotripsy. This sonic pressure wave treatment has been derived from a similar therapy used to treat patients with kidney stones.
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.
How Intravascular Lithotripsy (IVL) works
Intravascular Lithotripsy uses a small generator to produce sonic pressure waves from a catheter that is threaded through the arterial system to the site of the blockage in the heart. The technology was designed to produce pressure waves that pass safely through the soft vascular tissue, only impacting the hardened calcified plaque inside the artery 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 vessel. For an animation of the procedure, visit intravascularlithotripsy.com.