Julie Swain, MD
- RESEARCH PROFESSOR | Cardiovascular Surgery
Julie Swain, MD, is the Vice Chair for Clinical Performance for the Mount Sinai Health System and Director of the Center for Medical Devices (CMeD) at Mount Sinai Heart. In addition, she serves as Professor of Cardiovascular Surgery and Director of Clinical Research in the Department of Cardiovascular Surgery at the Icahn School of Medicine at Mount Sinai. Dr. Swain’s in-depth career experience includes:
Expertise in clinical trial design and regulatory experience
• Academic cardiothoracic and vascular surgeon for more than 21 years.
• University-based surgical practice in adult cardiac, thoracic, vascular surgery and intensive care unit medicine.
• Designed and conducted clinical research trials.
• Led cardiovascular physiology basic science laboratories.
• Collaborative research with US, European, Russia, Japanese, and Chinese scientists.
• Publications in cardiovascular and pulmonary basic science and translational clinical research.
• Consulted with industry and membership on Scientific Advisory Boards.
Long-term advisor to US Food and Drug Administration (FDA)
• Served as advisor to FDA for more than 20 years.
• Member and Chair of FDA Cardiovascular Advisory Panel (8 years), also served on FDA Urological and GI Devices Advisory Panel.
• Special Assistant to the Director, Division of Cardiovascular Devices (12 years) working with all of the Divisions in the FDA Center for Devices and Radiological Health/Office of Device Evaluation, and with experience in the Center for Biologics and the Center for Drugs.
• Working with industry (US and International), academics, and other government agencies in developing policy and in designing clinical study protocols, analyzing and interpreting data, and preparing Advisory Panel presentations.
• Co-author of FDA Guidance on Clinical Trial Design.
• Lead clinical reviewer fortranscatheter heart valve repair and replacement studies from the inception of the field to 2013. Worked with companies to design the studies, analyzed and reviewed the data from the studies, presented at the Advisory Panels.
• Lead clinical reviewer for Mechanical Circulatory Assist devices from 2002-2009. Developed performance goals for bridge-to-transplant and worked with companies to design studies, analyzed the data, and gave the FDA clinical presentation at Advisory Panel meetings.
• Lead clinical reviewer for medical devices for the fields of heart failure, treating myocardial ischemia, closing the left atrial appendage, PFO’s and septal defects, embolic protection, ECMO, therapeutic hypothermia, and cardiopulmonary resuscitation.
• Experience in developing and interpreting clinical studies for vascular grafts, neurological devices, stroke studies, infusion/implantation of biologics and cellular therapy for heart failure and angina, atrial fibrillation, vascular stents, pressure monitors, organ preservation, and pulmonary devices for treating emphysema.
• Particular interest and expertise in neurological effects of cardiovascular devices and studies for stroke, TIA, and migraine.
• Highly experienced in databases (STS, INTERMACS, and TCT).
• Developed performance goals and objective performance criteria for left ventricular assist devices and for transcatheter heart valves.
• Broad experience in working with statisticians on statistical design and interpretation of clinical trials.
• Long-term experience working with FDA epidemiologists on design and conduct of post-market studies.
• Extensive experience in working with engineers and veterinarians on preclinical study issues.
• FDA representative on the Valve Academic Research Consortium and the Mitral Valve Academic Research Consortium developing trial design, endpoint, and adverse event definitions for transcatheter valves.
• Advised FDA management on new trends in medical device development and use.
• Worked closely with CMS on reimbursement issues for medical devices.
• Membership on Data Safety Monitoring Boards for large NIH studies.
Abraham VS, Swain JA, Forgash AJ, Williams BL, Musulin MM. Ischemic preconditioning protects against paraplegia after transient aortic occlusion in the rat. The Annals of thoracic surgery 2000 Feb; 69(2).
Zhang P, Abraham VS, Kraft KR, Rabchevsky AG, Scheff SW, Swain JA. Hyperthermic preconditioning protects against spinal cord ischemic injury. The Annals of thoracic surgery 2000 Nov; 70(5).
Hartz RS, Swain JA, Mickleborough L. Sixty-year perspective on coronary artery bypass grafting in women. The Journal of thoracic and cardiovascular surgery 2003 Sep; 126(3).
Sapirstein W, Chen E, Swain J, Zuckerman B. US FDA perspective on regulatory issues affecting circulatory assist devices. Expert review of medical devices 2006 Nov; 3(6).
Swain JA, Hartz RS. Assessing quality in cardiac surgery: why this is necessary in the twenty-first century. Perfusion 2000 Jun; 15(3).
Swain J, Flynn E Jr, Greely W, Hallenbeck J, Liberthson R. Patent Foramen Ovale and Extravehicular Activity. Report to NASA Office of Life and Microgravity Applications 1999 November;.
Zuckerman B, Sapirstein W, Swain J. The FDA Role in the Development of Percutaneous Heart Valve Technology.. EuroIntervention Supplements 2006; 1(Supplement A): A75-A78.
Zuckerman B, Sapirstein W, Swain J. FDA perspective on clinical trial design for cardiovascular devices. Ann Thorac Surg. 2006 September; 82(3): 773-5.
Aguel F, Hillebrenner M, Stewart S, Swain J, Hampshire V, Zuckerman B. US Regulatory Decisions for Heart Valves Implanted with Minimally Invasive Surgery. Cardiovascular Engineering and Technology 2011; 2(2): 62-65.