Mount Sinai Offers Leadless Dual-Chamber Pacemaker, Capping a Decade of Pioneering Work

A journey that began nearly 10 years ago for Vivek Reddy, MD, with his implantation of the country’s first single-chamber leadless cardiac pacemaker, reached fruition in July 2023 when the U.S. Food and Drug Administration approved of the first dual-chamber device for the treatment of bradycardia. The AVEIR DR dual-chamber leadless pacemaker, made by Abbott, provides a catheter-based option that could revolutionize care for millions of people who require pacing of both upper and lower chambers of the heart.

In September 2023, another important milestone was reached when Dr. Reddy implanted the AVEIR DR in a 69-year-old man with high-grade atrioventricular block, making Mount Sinai Fuster Heart Hospital the first in New York City and one of the first in the nation to offer the device.

“Modern medicine has been filled with technological achievements that fundamentally changed how doctors approach patient care, and now we can add dual-chamber leadless pacing to that list,” says Dr. Reddy, Director of Cardiac Arrhythmia Services, Icahn School of Medicine at Mount Sinai. “In delivering true dual-chamber pacing, the system will expand access to the benefits of leadless pacing to more people than ever before, and provide additional options to improve our ability to treat people with irregular heart rhythms.”

The AVEIR DR system was found to be safe and effective in a multisite clinical trial of 300 patients conducted by investigators including Dr. Reddy. In the study, published in The New England Journal of Medicine in June 2023, 90 percent of patients met the device’s primary endpoint of adequate atrial capture threshold and sensing amplitude at three months. The implant success rate was 98.3 percent, and more than 97 percent of participants had successful atrioventricular synchrony at three months.

The dual-chamber pacemaker provides synchronized cardiac pacing between two devices: the previously approved AVEIR VR single-chamber device pacing the right ventricle, and the now-approved AVEIR AR single-chamber device pacing the right atrium. The new system uses high-frequency pulses to relay messages via the naturally conductive characteristics of the body’s blood between each leadless pacemaker. To support dual-chamber therapy, each implant communicates beat-to-beat with its implanted partner. This conductive communication is critical because it uses far less battery current than inductive, radio frequency, or Bluetooth communication used in traditional pacemakers.

“Another major difference is that AVEIR DR is implanted directly into the heart through a catheter procedure that eliminates the need for cardiac leads. As a result, leadless pacemakers reduce exposure to potential lead and infection-related complications, and offer a less restrictive and shorter recovery period following implantation,” says Dr. Reddy, the Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology at Icahn Mount Sinai.

Dual-chamber pacing is indicated for patients with sick sinus syndrome; chronic symptomatic second- and third-degree AV block; recurrent Adams-Stokes syndrome; and symptomatic bilateral bundle-branch block when tachyarrhythmia and other causes have been ruled out.

Size is a particularly important factor for AVEIR DR. Both of its single-chamber pacemakers are smaller than a AAA battery and can be implanted percutaneously. Another advantage over past technology is that the device is attached to the heart’s interior surface via a helical screw-in mechanism, allowing for future retrieval of the pacemaker should the therapy needs of the patient evolve, or if the device needs to be replaced at some point. The AVEIR DR is also designed to provide real-time analysis so that physicians can assess proper placement of the device both before and during implantation to the inside of the heart chamber.

The first patient to receive the pacemaker at Mount Sinai had three previous pacemakers but remained severely fatigued and out of breath, and was unable to do tasks such as lifting heavy objects or walking farther than his own driveway.

A week after Dr. Reddy and his team implanted the pacemaker, the patient said he was breathing better, and a month later, he took his first walk in a year and a half.

“I’m proud to have been part of this remarkable development story over the past decade,” says Dr. Reddy, one of the nation’s leading cardiac electrophysiologists. “Until now, leadless pacing was limited to stimulating the heart’s lower chambers, which made it practical for only 10 percent to 15 percent of patients worldwide who required pacemakers. The new dual-chamber AVEIR means that millions more can now benefit from its state-of-the-art technology and, just as important, that physicians who care for patients with abnormal heart rhythms will have a vital new tool in their armamentarium.”