Patient Received Investigational Implantable Defibrillator System Where Lead Is Placed Outside the Heart and Veins
Minneapolis, Minn. – Dec. 22, 2020 – Minneapolis Heart Institute Foundation® (MHIF) is among the first clinical research sites in the world to use a new, investigational medical technology to treat dangerously fast heart rhythms. As part of the worldwide Extravascular Implantable Cardioverter Defibrillator (EV ICD) Pivotal Study, Charles Gornick, MD, electrophysiologist and researcher at MHIF and director of electrophysiology at Minneapolis Heart Institute® and Bassam Shukrallah, MD, cardiac surgeon and researcher, MHIF, implanted the novel EV ICD system in a patient who is at risk of sudden cardiac arrest.
The investigational EV ICD system from Medtronic is designed to deliver lifesaving defibrillation and pacing therapy from an implanted device via a thin wire (called a lead) placed outside the heart and veins. In traditional, transvenous implanted defibrillator systems, the lead is threaded through the veins and into the heart.
“As research continues to advance options for our patients, this new approach to delivering lifesaving ICD therapy in a full-featured device, but without the risks associated with leads inside the veins and heart, is very appealing,” said Dr. Gornick. “I am so fortunate to do the work I do and offer a new innovative investigational technology that is possible for my patients because of clinical research.”
ICDs have been saving lives for more than 30 years by delivering a lifesaving shock or painless pacing therapy to stop dangerously fast heart rhythms that can lead to sudden cardiac arrest (SCA), a sudden, abrupt loss of heart function. Most SCA episodes are caused by the rapid and/or chaotic activity of the heart known as ventricular tachycardia (VT) or ventricular fibrillation (VF). SCA kills more than 350,000 people each year in the United States.1
The EV ICD pivotal study is a prospective, multicenter, single-arm, non-randomized, pre-market clinical study evaluating the new technology in up to 400 patients at up to 60 hospitals in North America, Europe, the Middle East, Asia, Australia and New Zealand.
About Minneapolis Heart Institute Foundation®
The Minneapolis Heart Institute Foundation (MHIF) strives to create a world without heart and vascular disease. To achieve this bold vision, it is dedicated to improving the cardiovascular health of individuals and communities through innovative research and education.
Scientific Innovation and Research – MHIF is a recognized leader across all specialties of heart and vascular research. Each year, MHIF leads more than 200 research studies with more than 2,200 patients and publishes more than 200 articles to share learnings from research. MHIF research has improved the standard of care around the world through protocols like Level One for heart attack, which significantly improved outcomes and survival for patients.
Education and Outreach – MHIF provides more than 10,000 hours of education each year putting its research into practice to improve outcomes among health care providers. This commitment extends to patients and caregivers through a number of community health and education events to raise awareness of heart care and research, engaging individuals in their own health.
The Minneapolis Heart Institute Foundation’s work is funded by generous donors and sponsors and engages in cutting-edge research initiatives with its physician partners from the Minneapolis Heart Institute® at Abbott Northwestern Hospital and at 38 community sites across Minnesota and western Wisconsin. For more information, please visit mplsheart.org.
# # #
1 Circulation. 2018;137:e67–e492. DOI: 10.1161/CIR.0000000000000558