Main Line Health participating in study showing IVL to be safe and effective in treating calcified arterial stenosis of the lower extremities
Use of intravascular lithotripsy (IVL) to treat severe calcifications of peripheral artery disease showed low residual stenosis, marked acute gain, and few complications despite increased disease complexity, according to the initial results of DISRUPT PAD III registry, an ongoing multicenter clinical study in which Main Line Health is participating.
IVL uses sonic pressure waves that pass harmlessly through soft tissue but fracture the calcified blockage. This nonrandomized, single-arm, observational clinical trial is testing the safety and effectiveness of the FDA-approved Shockwave Medical Peripheral Lithoplasty® system used in combination with adjunctive devices in a real-world clinical setting.
The newly published study examined the initial interval of trial enrollment between November 2017 and August 2018. At that time, about 1,300 patients from 18 sites in the United States and Europe were enrolled in the study and followed through hospital discharge. Eligible participants were those who had claudication or chronic limb-threatening ischemia and moderate or severe arterial calcification. To date, Main Line Health has been the second-leading enroller in the study, collecting data on more than 125 participating patients.
During the initial study period, 200 patients and 220 target lesions were treated with IVL in combination with either drug-coated balloon (DCB) catheters or, less frequently, concomitant atherectomy or stenting, as per the treating physicians’ preferences. The calcified lesions were located in the iliac artery, common femoral artery, superficial femoral artery, popliteal artery, and infrapopliteal vessels. Nearly one-third were chronic total occlusions.
Results showed significant lesion reduction and low residual stenosis across all lesion types. Only three angiographic complications in the complex lesion set were reported: two complex dissections and one perforation that occurred after DCB use unrelated to the IVL procedure. No instances of abrupt closure, reflow, distal embolization or thrombotic events were reported.
“This study shows the benefit of IVL in a real-world setting, assisting clinicians who treat complex peripheral artery disease with endovascular therapy,” said Sarang Mangalmurti, MD, a Lankenau Heart Institute cardiologist at Bryn Mawr Hospital and the Main Line Health principal investigator of the DISRUPT PAD III trial.
William A. Gray, MD, Main Line Health’s chief of the Division of Cardiovascular Disease, president of Lankenau Heart Institute and one of the study’s authors, noted: “At Main Line Health we remain committed to offering our patients the most advanced treatments available, which is why we participate in important clinical trials such as this. The knowledge gained from these studies can help to expand our therapeutic armamentarium.”
Dr. Gray also serves as a clinical professor of the Lankenau Institute for Medical Research, the research division of Main Line Health.
The initial results of DISRUPT PAD III trial were published in the manuscript “Intravascular Lithotripsy for Treatment of Calcified Lower Extremity Arterial Stenosis: Initial Analysis of the Disrupt PAD III Study” in the Journal of Endovascular Therapy. Drs. Gray and Mangalmurti coauthored this manuscript along with colleagues from other institutions.
About Main Line Health
Main Line Health® is a not-for-profit health system serving the greater Philadelphia region. The System comprises five hospitals, seven health centers, more than 160 outpatient and physician practice locations, over 14,500 employees and more than 2,200 employed and independent physicians and advanced practice providers.
Founded in 1985, Main Line Health includes four of the region’s most respected acute care hospitals — Lankenau Medical Center, Bryn Mawr Hospital, Paoli Hospital and Riddle Hospital — as well as Bryn Mawr Rehab Hospital, one of the nation’s premier facilities for rehabilitative medicine. The System also includes Mirmont Treatment Center, which provides treatment and support for substance use disorders; Main Line Health HomeCare & Hospice; Main Line HealthCare, its employed multispecialty physician network; Lankenau Institute for Medical Research, a leading biomedical research organization; and Main Line Health Centers offering primary and specialty care, lab, radiology and other outpatient services in Broomall, Collegeville, Concordville, Devon, Exton, King of Prussia and Newtown Square.
Main Line Health brings together physicians, advanced practice providers, nurses, researchers and other healthcare professionals across a broad network of inpatient, outpatient, home-based and community-based services. Through this integrated approach, the System delivers high-quality, comprehensive care across the continuum — from primary care and preventive services to complex specialty, surgical, trauma, emergency, rehabilitative, behavioral health, home care and hospice services — with a focus on making care accessible in the communities where people live and work.
Main Line Health also collaborates with leading clinical partners to expand access to specialized care. Through its affiliation with Children's Hospital of Philadelphia, pediatric care is provided at select Main Line Health locations, including neonatal intensive care units at its acute care hospitals and Bryn Mawr Hospital’s Inpatient Pediatric Unit and Emergency Department. Jefferson Health neurosurgeons and neurointerventionalists also provide 24/7 specialized care, including neurointervention and lifesaving stroke care.
About Lankenau Institute for Medical Research
Lankenau Institute for Medical Research (LIMR), part of Main Line Health, is a nonprofit biomedical research institute on the campus of Lankenau Medical Center celebrating its landmark 100th anniversary of scientific accomplishment in Fall 1927. LIMR's mission is to improve human health and well-being. Through its ACAPRENEURIAL™ organizational model, which integrates academic and entrepreneurial approaches, LIMR faculty and staff advance innovative strategies to address formidable medical challenges including cancer, cardiovascular disease, tissue regeneration, gastrointestinal disorders and autoimmune diseases such as rheumatoid arthritis. LIMR's principal investigators conduct basic, preclinical and clinical research, using their findings to improve disease detection, diagnosis, treatment and prevention. They are committed to extending the boundaries of human health through technology transfer and training the next generation of scientists and physicians.