Leadless Cardiac Pacemaker Changes Lives

Cardiac pacemakers monitor the heart and provide electrical pulses to the heart when it beats too slowly. 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.

Read below about a new ground-breaking device that changes the way pacemakers operate.

The John Ochsner Heart & Vascular Institute (JOHVI) at Ochsner Medical Center is the one of first facilities 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. 

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.

For more information, call 504-842-6201.