NEW ORLEANS – The John Ochsner Heart & Vascular Institute (JOHVI) at Ochsner Medical Center is the first facility in the Gulf South region to implant the Nanostim™ leadless pacemaker. Developed for patients with bradycardia – a heart rate that is too slow – the Nanostim™ device is placed directly in a patient’s heart via catheter without the visible lump, scar and insulated wires (called leads) required for conventional pacemakers. This is the world’s first retrievable, non-surgical pacing technology and is part of the LEADLESS II Clinical Trial
In Louisiana and Mississippi, Ochsner is currently the only provider to offer this technology and is one of handful of sites in the United States certified to implant this device.
Cardiac pacemakers monitor the heart and provide electrical stimulation when the heart beats too slowly for each patient's specific physiological requirements. More than four million people worldwide have an implanted pacemaker or other cardiac rhythm management device, and an additional 700,000 patients receive the devices each year.
Ochsner’s first implant procedure was performed by Michael Bernard, MD, PhD and Sammy Khatib, MD, electrophysiology and pacing, at John Ochsner Heart & Vascular Institute and lead principal investigators for the study.
“In the history of cardiac devices, there has been a continued improvement in technology that better enables us to take care of our patients in a less risky manner,” said Dr. Khatib. “In general, this improvement has been gradual in nature, but rarely, that progress is in the form of a giant step forward.”
How It Works
Conventional pacemakers work as part of a pacing system that consists of a pulse generator and pacing leads. They require the doctor to make a surgical incision in the chest where a pacemaker permanently sits in a pocket under the skin. The doctor then implants leads from the pacemaker through the veins into the heart. These leads deliver electrical pulses that prompt the heart to beat at a normal rate.
Unlike conventional pacemakers, a leadless pacemaker is placed by catheter via the leg and directly in the heart without the need for a surgical pocket and pacing leads. The device is much smaller and is comprised of a pulse generator that includes a battery and a steroid-eluting electrode that sends pulses to the heart when it recognizes a problem with the heart’s rhythm.
Leadless pacemaker technology is made up of computer chips and a small, but long-lived battery in a sealed case. The device is implanted through a vein that passes fairly close to the outer surface of the upper thighs. Because the implant procedure does not require surgery like a traditional procedure, it is considered a less-invasive approach for patients who need pacemaker technology.
“The small size of the device, coupled with the lack of a surgical pocket, not only improves patient comfort but can reduce complications such as device pocket-related infection and lead failure,” said Dr. Bernard. “This minimally-invasive option for pacemaker delivery will potentially improve the quality of life for patients allowing most to continue living active, uninhibited lifestyles.”
“We believe that the ability to implant a pacemaker without the need for leads, a visible/palpable device, and without a scar represents a giant step forward in the continued improvement of these devices,” said Dr. Khatib. “It is a game changer.”
The device is supported by the St. Jude Medical Merlin™ Programmer, which is also used to interrogate and program the company’s other pacemakers and implantable cardioverter defibrillators (ICDs).
This is the world’s first retrievable, non-surgical pacing technology and is part of the LEADLESS II Clinical Trial, a prospective, non-randomized, multi-center, international clinical study designed to evaluate the safety and effectiveness of the Nanostim™ leadless pacemaker in patients indicated for the device in the U.S. The study is expected to enroll approximately 670 patients at 50 centers.
The Nanostim™ leadless pacemaker received CE Mark approval in 2013 and is now available in select European markets. The device is not available for sale in the U.S.
The John Ochsner Heart & Vascular Institute has received numerous accolades. U.S. News & World Report named Ochsner’s Cardiology and Heart Surgery departments among the top 25 across the country in its 2013-14 Best Hospitals rankings. Additionally, Healthgrades ranked Ochsner #1 in Louisiana for Overall Cardiac Services, Cardiology Services and Coronary Interventional Procedures.
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Ochsner Health System is southeast Louisiana’s largest non-profit, academic, multi-specialty, healthcare delivery system. Driven by a mission to Serve, Heal, Lead, Educate and Innovate, coordinated clinical and hospital patient care is provided across the region by nine hospitals, both owned and managed, and more than 40 health centers in Louisiana. Ochsner has been named the Consumer Choice for Healthcare in New Orleans for 18 consecutive years and is the only Louisiana hospital recognized by U.S. News & World Report as a “Best Hospital” across eight specialty categories. Ochsner employs more than 14,000 employees, over 900 physicians in over 90 medical specialties and subspecialties and conducts over 300 clinical research trials annually. Ochsner Health System is proud to be a tobacco-free environment. For more information, please visit ochsner.org and follow us on Twitter and Facebook.