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Bryn Mawr Hospital, Lankenau Heart Institute, participates in landmark study using sonic pressure waves to treat heart artery blockages

Bryn Mawr Hospital April 18, 2019 Research News

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.

About Main Line Health

Founded in 1985,Main Line Health is a not-for-profit health system serving portions of Philadelphia and its western suburbs. Main Line Health’s commitment—to deliver advanced medicine to treat and cure disease while also playing an important role in prevention and disease management as well as training physicians and other health care providers—reflects our intent to keep our community and ourselves well ahead. A team of more than 10,000 employees and 2,000 physicians care for patients throughout the Main Line Health system.

At Main Line Health’s core are four of the region’s most respected acute care hospitals—Lankenau Medical Center, Bryn Mawr Hospital, Paoli Hospital and Riddle Hospital—as well as one of the nation’s recognized facilities for rehabilitative medicine, Bryn Mawr Rehabilitation Hospital.

Main Line Health also includes Mirmont Treatment Center for drug and alcohol recovery; Main Line Health HomeCare & Hospice, which includes skilled home health care, hospice and home infusion services; Main Line Health Centers, primary and specialty care, lab and radiology, and other outpatient services located in Broomall, Collegeville, Concordville, Exton, King of Prussia and Newtown Square; Lankenau Institute for Medical Research, a biomedical research organization; and Main Line HealthCare,one of the region’s largest multispecialty physician networks.

Main Line Health is the recipient of numerous awards for quality care and service, including System Magnet® designation, the nation’s highest distinction for nursing excellence and the Mid-Atlantic Alliance for Performance Excellence (MAAPE) Excellence Award. Main Line Health is committed to creating an environment of diversity, respect and inclusion and has proudly embraced the American Hospital Association’s #123forEquity Pledge to Act to eliminate disparities in care. We are dedicated to advancing patient-centered care, education and research to help our community stay healthy.

About Lankenau Heart Institute

The Lankenau Heart Institute is Main Line Health’s premier, comprehensive cardiovascular medicine and surgery program. The Lankenau Heart Institute brings together the clinical expertise of all four Main Line Health acute care hospitals and community cardiology practices to ensure that patients receive a level of quality, service, and experience that is unprecedented in the region. Through the system-wide coordination of services, the Lankenau Heart Institute delivers preventive, diagnostic, therapeutic, and rehabilitative cardiovascular services at each of our locations including Lankenau Medical Center, Bryn Mawr Hospital, Paoli Hospital and Riddle Hospital.

Lankenau Heart Institute continues to be a pioneer in the use of beating-heart techniques and robotic-assisted procedures for coronary artery revascularization, minimally invasive and transcatheter approaches for valve repair and replacement, and complex aortic surgeries. With our growing experience and focus on minimally invasive techniques, Lankenau Heart Institute has expanded participation in clinical trials year over year. Our physicians are frequently invited to participate in clinical/medical device trials, many of these designed to facilitate minimally invasive procedures/approaches.

With a collaborative team of expert consultative cardiologists, interventional cardiologists, electrophysiologists, cardiovascular surgeons and specially trained nurses and technologists, the Lankenau Heart Institute is dedicated to managing and treating patients with heart failure, aortic disease, coronary and peripheral vascular disease, heart rhythm disorders and valve disease. Our team of cardiologists and cardiac specialists provide patients and their families with expert cardiac care, close to home.