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

Founded in 1985, Main Line Health is a not-for-profit health system serving Philadelphia and its suburbs. Main Line Health's commitment — to deliver safe, high-quality, equitable and affordable care for treating and curing disease, playing an important role in prevention and disease management, as well as training physicians and other health care providers — reflects our intent to be the region's premier choice for clinical care, research, and education. A team of more than 13,000 employees and over 3,500 employed and independent physicians and advanced practice providers care for patients throughout Main Line Health.

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 premier facilities for rehabilitative medicine, Bryn Mawr Rehab 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 the prestigious American Hospital Association Quest for Quality Prize, highest tier ratings from the Centers for Medicare & Medicaid Services (CMS) for Overall Hospital Quality and systemwide recognition in the 2023-2024 U.S. News & World Report Best Hospitals rankings. Main Line Health is committed to creating an environment of diversity, respect, equity and inclusion, has proudly received awards in this area and has 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 patients stay healthy and live their best lives.

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About Lankenau Institute for Medical Research

Lankenau Institute for Medical Research (LIMR) is a nonprofit biomedical research institute located on the campus of Lankenau Medical Center and is part of Main Line Health. Founded in 1927, LIMR's mission is to improve human health and well-being. Using its ACAPRENEURIALTM model that integrates academic and entrepreneurial approaches, faculty and staff are devoted to advancing innovative new strategies to address formidable medical challenges including cancer, cardiovascular disease, tissue regeneration, gastrointestinal disorders and autoimmune diseases such as diabetes and arthritis. LIMR's principal investigators conduct basic, preclinical and clinical research, using their findings to explore ways to improve disease detection, diagnosis, treatment and prevention. They are committed to extending the boundaries of human health through technology transfer and training of the next generation of scientists and physicians.