UT Southwestern cardiac electrophysiologists were among the first 2% of physicians worldwide to get training on the dual chamber leadless pacemaker.
The world’s first leadless dual-chamber pacemaker was approved by the FDA in 2023, and UT Southwestern was among the first heart centers in Texas to offer the advanced technology
About 3 million people in the U.S. live with a pacemaker, a battery-powered device implanted in the chest to help the heart beat at its proper rate. Each year, about 200,000 devices are implanted in the U.S. for patients who have bradycardia (slow heartbeat) or abnormal heart rhythms.
While traditional pacemakers have saved many lives, their design, created in the 1950s, can seem outdated in today’s high-tech world of medicine. Leads, or thin wires, are attached to a battery-powered generator implanted beneath the skin near the collarbone. The leads, which send electrical signals to regulate the heartbeat, and the “surgical pocket” needed to house the battery create a 1% to 12% chance of complications – ranging from infections and blood clots to air leaks and collapsed lung.
In 2023, the U.S. Food and Drug Administration in 2023 approved the world’s first leadless dual-chamber pacemaker, a potential gamechanger for the nearly 80% of patients who require pacing of both the upper and lower chambers of the heart. UT Southwestern is one of just nine heart centers in Texas to offer this advanced technology, which implants two capsule-shaped devices smaller than AAA batteries directly inside the heart in a catheter-based procedure, with no large incisions and no lead wires.
Single-chamber leadless pacemakers, which only pace the ventricle, were introduced in 2016. The Aveir™ DR Dual Chamber Leadless Pacing System paces both the top (atria) and bottom (ventricles) chambers, with no leads and no surgical “pocket” required, reducing the risk of complications. The two capsules use wireless technology and high-frequency pulses to communicate with each other.
Dr. Patel and Dr. Daniels, cardiac electrophysiologists in UTSW’s Clinical Heart and Vascular Center, were among the first 2% of physicians worldwide to get training on this device. They implanted the first dual chamber leadless pacemaker system in a patient at UTSW in February 2024. Since then, they have performed multiple successful procedures with the new technology, which could fundamentally change how we treat patients with irregular heart rhythms.
Two devices smaller than AAA batteries power the pacemaker. (Photo: Abbott)
How does it work?
In the dual chamber system, two small devices are implanted, one in the atria, one in the ventricle. Communicating by sending signals through the blood, these devices help the heart beat more naturally. Called atrioventricular (AV) synchrony, this coordinated contraction of the heart – first atria, then ventricles – is the most efficient way for the heart to pump blood. More importantly, it helps patients recover more quickly from the procedure than traditional pacemakers.
The minimally invasive procedure to implant the device takes about 45 minutes – averaging 20 minutes per chamber. Patients receive sedation and a local anesthetic. The surgeon makes a tiny incision in the groin and threads a small tube, or catheter, through the blood vessels into the heart, guided by real-time X-ray images.
The cardiologist inserts the two individual pacemaker capsules through the catheter and attaches them to the wall of the right atrium and the right ventricle. After the catheter is removed and the incision is closed, most patients spend an hour or two in the hospital before going home.
What are the benefits?
The dual chamber leadless pacemaker offers several important advantages, including:
- Eliminates some risks associated with transvenous, or traditional, pacemakers: Such as pocket hematoma and infection and lead fracture or dislodgment. The leadless pacemaker is particularly well suited to people with a weakened immune system or who had prior infections from implanted devices.
- Fewer activity restrictions: We ask patients not to lift anything heavy for about a week after surgery. Many patients whose work doesn’t involve lifting return to their job the day after the procedure. Otherwise, patients have no activity restrictions after the first week of recovery.
- Cosmetic advantages: Avoids visible incisions or bumps on the skin from a device.
- Extractability: Devices can be removed and reimplanted easily when the battery gets depleted.
- No problems with airport security or MRIs: The leadless dual pacemaker is shielded against interference from technologies such as MRIs and metal detectors at airport security or major sporting events. Some patients choose to use a medical ID card to alert personnel anyway, but the system inside the heart is unlikely to set off alarms or cause any problems.
What's next?
The dual chamber leadless pacemaker is an important advancement in cardiology care, and our experience suggests it will become more common and accessible over time.
The minimally invasive procedure opens the door for patients with a high risk of infection such as being immunocompromised or having a prior lead-related infection. By combining our expertise in internal medicine and this new approach, we can give more patients the opportunity for a healthier heart rhythm for years to come.
To visit with a cardiologist about your heart health, call 214-645-8300 or request an appointment online.
