Novel Leadless Pacemaker Prevents Invasive Surgeries

Medical Design Briefs INSIDER

The team’s design for a pericardial leadless micropacemaker. (Credit: Children’s Hospital Los Angeles)

Researchers have created a groundbreaking prototype for a new kind of leadless pacemaker designed for both children and adults. The innovative micropacemaker would be the first fully leadless system to be placed in the pericardial space surrounding the heart. That would allow the device to be implanted in a minimally invasive way in children and those with congenital heart disease, while also providing a lower-risk leadless pacemaker option for adults.

This would be the first pacemaker that stays entirely out of the heart and has absolutely no leads. There are currently two FDA-approved leadless pacemakers, and both are delivered through the femoral vein and then placed inside the right heart.

Leadless devices were an important advance because leads are the fail point of pacemakers — they tend to break over time. However, there are significant concerns with placing these leadless pacemakers in young patients (including the very large sheath size in the vein and the potential challenges of removing the devices from inside the heart).

This small leadless pacemaker does not go through the veins but rather is put on the outside of the heart instead of the inside. This means it could be used for children and those with congenital heart disease, and it could carry fewer risks for adults as well.

Current leadless devices are placed on the inside of the heart, which can cause a perforation when they are implanted. They also theoretically can fall out of place. If that happens, the device could go to the lungs, which would be quite dangerous.

The design of the new device eliminates those risks. Another advantage of the system is that it does not have to go in the right ventricle. It could pace the left ventricle, which is more ideal for optimizing the cardiac squeeze. In addition, more than one device could be put in, whether added in the atrium to allow dual-chamber pacing (as often done in standard pacemakers with leads) or on the other ventricle for biventricular pacing (also known as cardiac resynchronization therapy).

The team is seeking an industry partner to help develop the device so that it can be tested in humans.

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