By GREGORY ZELLER //
The world’s smallest defibrillator lead is now in play at Northwell Health.
Cardiologists at North Shore University Hospital’s Sandra Atlas Bass Heart Hospital have implanted the smallest defibrillation lead ever designed into a 77-year-old Long Island man. The Jan. 7 procedure made the team at the Manhasset-based cardiac center the first in the world to deploy the OmniaSecure MRI SecureScan defibrillation lead, a novel advancement in transvenous defibrillation-lead technology designed and distributed by Irish medical-device kingpin Medtronic.
Eschewing the increased potential for downstream complications common with larger-diameter leads – artery blockages, tricuspid valve regurgitation and other dangerous developments – the OmniaSecure lead measures only 4.7 French (referencing a standard gauge for measuring medicinal tubes, with 1 French equaling one-third of a millimeter).
Small wonder: The OmniaSecure MRI SecureScan packs a lot into its 4.7 French.
Designed for pacing, sensing, cardioversion and defibrillation therapies, the relatively tiny lead does a fine job sensing the heartbeat and transmitting signals to an implanted defibrillation device – but at roughly half the size of standard defibrillation leads, representing “a significant advancement in cardiac-device technology,” according to Northwell Health Electrophysiology Director Laurence Epstein.
“For the first time, we can provide both lifesaving defibrillation and physiologic pacing through a single, streamlined device,” Epstein noted. “By screwing the lead deep into the heart’s septal wall, we can engage the normal cardiac-conduction system, essentially mimicking the heart’s natural electrical pathway.”
The U.S. Food and Drug Administration greenlighted the single-coil, integrated bipolar lead for patients ages 12 and up in April, following a global Lead Evaluation for Defibrillation and Reliability clinical study that assessed OmniaSecure’s safety and effectiveness. North Shore University Hospital and sister Northwell Health facility Staten Island University Hospital, home to the Lois & Richard Nicotra Heart Institute, both participated in the trial, which tested the device when implanted at traditional locations in the right ventricle.
Jeffrey Kuvin, Northwell Health’s senior vice president of cardiology and co-executive director of the Northwell Cardiovascular Institute, applauded the health system’s participation in the cutting-edge clinical trial and heralded the deployment of the next-generation defibrillation lead as “a global milestone.”
“Congratulations to our cardiology teams at the Northwell Cardiovascular Institute and the Sandra Atlas Bass Heart Hospital for … being able to offer our patients the absolute latest breakthrough not only in technology, but in in cardiac patient-centric care,” Kuvin said in a statement.
Epstein, who led the Jan. 7 surgical procedure, credited Northwell Health’s cardiac experts with once again operating ahead of the curve.
“Our dedicated team of physicians, advanced-care practitioners and technicians work together to drive cutting-edge innovation focused on enhancing patient outcomes and delivering the best quality care,” Epstein added.
