A Long Island hospital is the first in the nation to implant a novel defibrillator outside a patient’s heart and veins.
Cardiologists at the Sandra Atlas Bass Heart Hospital at North Shore University Hospital in Manhasset performed the procedure to treat a patient with a dangerously fast heart rhythm who was at risk of sudden cardiac arrest.
They implanted the Aurora Extravascular Implantable Cardioverter-Defibrillator (EV-ICD), which was developed by Medtronic.
The system was approved by the U.S. Federal Drug Administration for commercial use on Oct. 23, a Medtronic spokesperson said, confirming that the Long Island hospital, which is part of the Northwell Health system, was the first in the nation to implement the device.
The new implantable defibrillator allows cardiologists to place the lead, or wire, under the breastbone, outside of the heart and veins. It delivers lifesaving defibrillation and paces dangerously rapid heartbeats in one system.
Experts describe the procedure as “minimally invasive,” and in this instance was performed by Dr. Laurence Epstein, the system director of electrophysiology at Northwell.
“The first-of-its-kind Medtronic implantable defibrillator provides innovative technology that offers several benefits over traditional ICDs,” Epstein said in a written statement. “With the new device, the lead can be tunneled under the sternum, outside the heart, reducing the risks of long-term complications, such as blood infections. Also, since the lead is closer to the heart, it is more energy efficient with a smaller device and longer battery life.”
Jeffrey Juettner, a 61-year-old Riverhead resident, was the first patient in the country to receive the new Medtronic implantable defibrillator. Juettner, a longtime carpenter, had been working through shortness of breath. His symptoms worsened, and on the morning of Oct. 29, he went to the emergency department at Peconic Bay Medical Center, part of Northwell. He was diagnosed with severe heart failure, and after consultation with cardiologists there, he was transferred to the Manhasset hospital for advanced heart failure therapy. Given his young age and risk of future infection, Epstein determined Juettner would be a good candidate for the new heart device.
The Medtronic EV-ICD system was evaluated in a worldwide pivotal study, involving 356 patients at 46 hospitals in Europe, North America, the Middle East, Asia, Australia and New Zealand. The Sandra Atlas Bass Heart Hospital had participated in the trial. In the study, the EV-ICD System achieved a defibrillation success rate of 98.7 percent and met its safety endpoints of freedom from major system and/or procedural complications at six months after implant. Results were published in The New England Journal of Medicine.