World's First Dual-Chamber Leadless Pacemaker: 'It Changed My Life'

After developing neurocardiogenic syncope following a car crash, a young woman explains how receiving the world’s first dual-chamber leadless pacemaker system gave her back her quality of life.

Sara Wykurz was just 18 years old when her world was turned upside down by a head-on collision with a drunk driver. The now 29-year-old was driving down a neighborhood street in Chicago when she was suddenly faced with a driver coming straight towards her, leaving her nowhere to turn.

“I lost full consciousness and woke up not knowing what had just happened,” Wykurz tells Healthnews.

Once she was released from the hospital, Wykurz went to physical therapy for several weeks due to a slipped disc in her neck, which she says still causes her terrible pain and tension to this day. It quickly became clear that this wasn’t her only injury.

Almost immediately after the accident, Wykurz began experiencing regular syncopal episodes — or fainting spells — in which she would lose full consciousness and collapse to the ground.

She says she would always experience an aura — or a warning sensation — right before it was about to happen, symptoms that would cause her an immense amount of fear and anxiety.

“In the beginning I didn’t know what to do, and I would always end up with some sort of injury,” she says. “As time went on, I learned to sit or lay down to not injure myself.”

Despite the frequency of these fainting spells, Wykurz went years without answers. She initially received an echocardiogram, or "echo,” which looked at the heart and blood vessels, though it revealed nothing about her condition. She then began seeing a neurologist who prescribed her with Keppra — an epilepsy medication she would end up needlessly taking for an entire decade.

It wasn’t until she was working for a medical devices and healthcare company at the age of 28 that she noticed that many of the patients coming in had the same symptoms she did, and they were all receiving pacemakers.

Under my doctor’s guidance, I received an implantable cardiac monitor called a Jot and that recorded multiple episodes of no heart rate for 15-20 seconds.

Wykurz

What is neurocardiogenic syncope?

After a decade of being misdiagnosed, Wykurz was finally told she had a condition called neurocardiogenic syncope and that she’d need a pacemaker.

“I was relieved to know there was a solution and hoped to [have] a normal life without constant worry and stress,” she says.

Neurocardiogenic syncope is a condition in which the vagus nerve is sometimes activated at the wrong time, causing blood vessels to dilate and the heart to slow down — occasionally even stopping the heart for several seconds, according to Dr. Mohammed Mortada, a cardiologist and electrophysiologist at Advocate Health Care in Milwaukee, Wisconsin — and the doctor who would eventually operate on Wykurz.

He says the condition is transient but causes fainting and possible injuries, and it can be particularly frustrating for patients due to challenges in diagnosing it. There is no test for the condition, and it is instead diagnosed through a process of elimination.

Most devastating, he says, is the fact that it often scares patients from living their lives fully due to the risk of fainting and injuries.

Mortada says about 30% of the population will experience at least one episode of neurocardiogenic reaction in their life. But only some, like Wykurz, will have multiple episodes, requiring a pacemaker.

For a physically active 28-year-old, however, a traditional pacemaker with leads (wires going directly into the heart) would have been extremely restrictive and a frankly impractical option.

As a result, her doctor recommended she participate in a clinical trial for the world’s first dual-chamber leadless pacemaker system. That’s how she met Mortada, who would soon change her life for the better.

The clinical trial that changed it all

The world’s first dual-chamber leadless pacemaker system, called the Aveir DR by Abbott Laboratories, consists of two small devices: one that’s responsible for pacing the heart’s right ventricle (which pumps blood low in oxygen to the lungs) and one that paces the heart’s right atrium (which receives blood low in oxygen from the body). The devices are implanted using a catheter-based procedure, which is minimally invasive, according to Mortada.

The system uses unique technology that allows the two devices to synchronize and communicate between them without wires.

“If the heart stops, the pacemaker will pace instantly without the patient feeling the episode and that will prevent the fainting from happening,” Mortada explains.

The device allows patients to quickly return to normal activities since it has a brief recovery period compared to a traditional pacemaker, which requires at least a month of recuperation. Within just four days of undergoing the procedure, Wykurz was back in the gym weightlifting.

“It was like night and day,” Mortada says of the impact it has had on Wykurz. “Avoiding the traditional pacemaker helped her to go back to full activity within a week without being concerned about any leads (wires) dislodgement or fracture. [There were] no further fainting episodes, making her enjoy her life and go back to her normal exercising without being worried about fainting and injuring herself.”

Leadless pacemakers work like traditional pacemakers, except a traditional pacemaker requires an incision under the clavicle bone to implant the actual pacemaker device. It also requires two leads (wires) going through the veins and into the heart to connect the pacemaker with the heart tissue.

Over time, Mortada says, a traditional pacemaker can cause chest discomfort where it has been implanted, venous occlusion, lead (wire) fracture, risk of infection, and other complications that the leadless pacemaker does not have. A traditional pacemaker also requires restriction to the left arm for at least a month after the implant.

Wykurz says she was particularly enthused by the fact that this system is retrievable, meaning the devices are easy to retrieve and replace when need be. Currently, her top chamber battery has eight years left on it, and the bottom chamber device has 24 years left — which she says is particularly impressive given how small the devices are.

Wykurz received the dual-chamber Aveir DR in October of 2022 as a part of a clinical trial. The results from the trial, published in the New England Journal of Medicine, showed that over 97% of the 295 patients saw both chambers of their heart beating normally after just three months. The system was officially approved by the FDA in June of 2023.

Perhaps the best part of this technology, Wykurz says, is that it leaves no scar or visible trace.

“The neat thing is that no one knows I even have one,” Wykurz says. “The Aveir DR is an incredible piece of technology that has changed my life.”