A dual-chamber wireless pacemaker has shown reliable performance over three months, according to an international clinical trial led by researchers from Weill Cornell Medicine and NewYork-Presbyterian.
The study results, published on July 8 in Circulation, demonstrated that this pacemaker system, made up of two small devices, effectively synchronizes the heart’s upper and lower chambers 98% of the time.
The research team, including Dr. James Ip, a cardiac specialist at Weill Cornell, also found that the device works well during various activities and elevated heart rates.
Dr. Ip expressed excitement about this advancement, stating, “We’ve entered a new era of pacing. We now have new technology and methods to help patients and reduce complications.”
Pacemakers help regulate heartbeats in people with slow heart rhythms by delivering electrical signals. Traditional pacemakers are implanted under the skin in the chest and have wires (leads) that run through veins to the heart. However, these wires can cause complications.
“The wire is the Achilles heel of the pacemaker,” said Dr. Ip. “If you bend it enough times, it can break. While wired pacemakers have been the standard for reliable pacing, the technology can be improved.”
If a wire breaks, it must be removed, which can be difficult if scar tissue has formed. Additionally, bacteria can attach to the wires, leading to severe bloodstream infections. People who frequently move their arms a lot are at a higher risk of wire breakage.
Individuals who are thinner or have thin skin may risk the device eroding through the skin. Patients with blocked vessels, compromised immune systems, or those on dialysis are also not ideal candidates for wired pacemakers.
About ten years ago, wireless pacemakers were introduced that could stimulate the heart’s lower chamber (ventricle), providing an alternative to wired devices for some heart rhythm problems.
These tiny devices are inserted through a blood vessel in the groin and placed in the heart, making the procedure less invasive than traditional pacemaker implantation.
In May 2023, a study published in the New England Journal of Medicine, co-authored by Dr. Ip, showed the safety and effectiveness of a wireless pacemaker implanted in the heart’s upper chamber (atrium) that can stimulate both the upper and lower chambers.
This study led to the FDA’s approval of the device in July 2023, expanding the availability of wireless pacemakers to patients with a broader range of heart rhythm issues.
The new study provides longer-term data on the dual-chamber pacemaker’s reliability under different conditions, such as when patients are active or change positions.
During a follow-up visit three months after implantation, 384 patients wore external heart monitors to assess the device’s performance during various activities.
“We have proven that the two separate pieces of the new pacemaker system communicate very well, even when people change positions or engage in activities,” Dr. Ip said. “Also, the device performs better than how it tells you it is functioning.”
Dr. Ip suggested that clinicians could rely on the device’s recordings rather than asking patients to wear cumbersome heart monitors for assessment.
However, he noted that these devices are still in their first generation and have some drawbacks, such as smaller batteries that may not last as long as those in traditional wired pacemakers.
He expects that wireless pacemakers will improve as technology advances. Meanwhile, he and his colleagues will continue to evaluate their performance, offering patients a valuable new option.
“I’ve been involved in researching and implanting wireless pacemakers for over a decade, starting with animal studies, then clinical trials in humans, and now after FDA approval,” Dr. Ip said.
“It is very gratifying to see how the technology has evolved over time and how these devices genuinely help people.”
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The research findings can be found in Circulation.
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