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Leadless Pacemakers an Option for a Growing Number of Patients: Studies Show Benefits But Greater Awareness Is Needed to Educate Patients About Their Pacing Options

February 12, 2021

By Laurence M. Epstein, M.D.
System Director, Electrophysiology, Northwell Health
Professor of Cardiology, Zucker School of Medicine at Hofstra/Northwell

Leadless pacemakers: Since they were FDA-approved in 2016, leadless pacemakers have offered patients a variety of advantages including fewer complications during and after implantation and a lack of a visible scar. But they’ve also been limited to a select group of patients requiring pacemakers – at least until recently.

Five years ago, only a fraction of pacemaker-eligible patients qualified for this type of device. Now, the patient pool has expanded thanks to recent advancements in pacing technology.

Yet despite this increased eligibility and the many advantages that leadless pacemakers can offer compared to traditional pacing systems, many pacemaker candidates still aren’t aware of the devices. By making sure patients know about their pacing options, they can have a more informed discussion with their doctor about whether a leadless device may be right for them.

Benefits of Leadless Pacemakers

Leadless pacemakers and traditional pacemakers are both options for treating arrythmias, which are irregular heartbeats that occur when the electrical impulses in the heart function abnormally. A common arrythmia that may require pacemaker therapy is bradycardia, where the heart beats too slowly. Bradycardia can occur when the normal pacemaker (Sinus Node) of the heart beats too slowly and atrioventricular (AV) block, where the flow of electrical signals between heart chambers is impaired.

Traditional pacemakers have been an essential tool in treating slow heart rhythms for more than 60 years, but they can have some drawbacks. The device is connected to the heart by thin wires called “leads,” which are implanted under the skin in the upper chest, just below the collar bone. Both this chest incision and the surgical “pocket” that remains after it can create the risk of infection in rare cases.

A traditional pacemaker can also have a lasting personal impact on the patient. The device can be felt under the skin, and it can leave a scar that remains visible to the patient long after their procedure.

At less than one-tenth the size of a traditional pacemaker – or about the size of a large vitamin capsule – a leadless pacemaker may be a better option for some patients for several reasons.

A leadless device is implanted directly within the heart through a minimally invasive procedure. In fact, a real-world study found leadless pacemakers were associated with a 63% reduction in major complications compared to traditional pacemakers with leads, as there is no chest incision or surgical pocket that could be a site of infection.

The ability to avoid a chest incision also has cosmetic benefits. After implantation, the patient has no visible bump or chest scar, which can be a concern with some patients and in some cultures.

Leadless pacemakers can also improve the patient experience in other ways. After the implantation of standard pacemakers patients must limit their activity for 4-8 weeks to prevent the wires (leads) from dislodging. Rarely, especially in active patients the wires can break, requiring replacement. Since leadless pacemakers have no leads, these are not an issue.

What’s more, all these benefits come while also preserving traditional pacemaker capabilities.

Improving Awareness

Despite the advantages, many pacemaker candidates either aren’t aware of leadless pacing or don’t realize there are other options available for pacemaker therapy. This is in part due to the fact that a number of physicians are just learning about this technology themselves.

To educate patients about the pacing options available to them, the non-profit organization Mended Hearts, in collaboration with Medtronic, recently launched Pace of Mind. This educational initiative provides resources for patients diagnosed with a heart condition or who have learned they need a pacemaker.

Patients who visit can learn about what to expect before, during and after a pacemaker procedure, and how to discuss their pacing options with their doctor. They can also view firsthand stories of others whose lives have been positively impacted by a leadless device and find a physician in their area who has experience in leadless pacing therapy.

Learn More

Leadless pacemakers offer an array of benefits for pacing candidates, both surgical and cosmetic, but ongoing education will be needed to bring this groundbreaking technology to more patients.

Initiatives like Pace of Mind can play a key role in this regard, empowering pacemaker-eligible patients with the knowledge they need to have an informed conversation with their doctor about leadless pacing.

For more information and resources, visit

Laurence M. Epstein, M.D., is system director of electrophysiology at Northwell Health and a consultant for Medtronic.

Medical Device News Magazine
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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