Dual-Chamber Wireless Pacemaker Delivers Lasting and Reliable Performance

Traditional pacemakers are implanted under the skin in the chest, with leads extending through the veins into the heart. Despite their effectiveness, these devices come with risks; for instance, leads can break and are challenging to remove if they become surrounded by scar tissue. They can also become sites for bacterial attachment, potentially causing severe infections. Furthermore, patients with high levels of physical activity, thin individuals, or those with compromised vessels or immune systems may face greater risks with wired pacemakers.

Around a decade ago, wireless pacemakers were introduced, capable of stimulating the heart’s ventricle, providing a less invasive alternative for certain patients with heart rhythm issues. These small devices are inserted via a blood vessel in the groin directly into the heart and fixed in place. In May 2023, clinical trials validated the safety and efficacy of a wireless pacemaker that can stimulate both the atrium and ventricle. In July 2023, this dual-chamber wireless pacemaker received U.S. Food and Drug Administration (FDA) approval, widening the available treatments for patients with diverse cardiac rhythm disorders. Now, a new study supports the long-term reliability of this dual-chamber wireless pacemaker over three months.

Co-led by Weill Cornell Medicine (New York, NY, USA), the follow-up multi-center, international clinical trial expanded on earlier findings by examining the device’s performance under various conditions, such as increased heart rates or changes in posture. At a three-month follow-up, 384 participants from the initial trial wore an external heart monitor during different activities to monitor the device's effectiveness. Published on July 8 in Circulation, the study results confirmed that the device’s components communicated effectively, synchronizing the heart’s upper and lower chambers' contractions 98% of the time. The device also performed well during physical activities and when heart rates increased.

The researchers advocate for using the device’s own data for performance assessments rather than external monitors, though they note that as first-generation devices, they have some limitations, such as shorter battery life compared to traditional pacemakers. However, improvements are anticipated as technology advances. Meanwhile, ongoing studies will continue to assess the performance of these leadless pacemakers, which provide a significant alternative for patients.

“We’ve entered a new era of pacing,” said Dr. James Ip, professor of clinical medicine at Weill Cornell Medicine. “We are not limited to the wired devices we’ve been using for more than 60 years. We now have new technology and methods to help patients and reduce complications.”

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