Look ma – no wires! Colorado’s first commercial dual-chamber leadless pacemaker implant a success

Abbott’s Aveir DR uses novel communications to synchronize two independent devices in separate chambers of the heart.
May 14, 2024
Richard Bloomfield is looking forward to getting back up onto the trails near his home in Gypsum. In April, Broomfield received the first commercial dual-chamber leadless pacemaker ever implanted in the state of Colorado. Photo by Brayden Bloomfield for UCHealth.
Richard Bloomfield is looking forward to getting back up onto the trails near his home in Gypsum. In April, Broomfield received the first commercial dual-chamber leadless pacemaker ever implanted in the state of Colorado. Photo by Brayden Bloomfield for UCHealth.

On April 1, Richard Bloomfield, 70, of Gypsum, Colorado, received the first commercial dual-chamber leadless pacemaker ever implanted in the state of Colorado. The minimally invasive procedure involving Abbott’s Aveir DR devices – two shiny, quarter-inch-wide cylinders less than an inch-and-a-half long – now steady the beat of a heart that wasn’t originally his.

University of Colorado School of Medicine cardiac electrophysiologist Dr. Matthew Zipse performed the procedure at UCHealth University of Colorado Hospital on the Anschutz Medical Campus. Zipse snaked a catheter via Bloomfield’s femoral vein near the groin up and into the right ventricle, screwing the corkscrew tip of one Aveir cylinder into the ventricular wall. He then did the same with a slightly smaller pacemaking cylinder in the right atrium above it. The procedure took about two hours; Bloomfield was back home the next day.

The two Aveir cylinders now spend most of their time in standby mode. When they detect an irregular or delayed heartbeat, they do what pacemakers do: deliver tiny zaps of electricity to nudge the pump into proper behavior. What’s unique here is that the cylinders work in synchrony because they can talk to each other by using the bloodstream and heart tissues as conductors to transmit a sort of morse code back and forth (doing so takes far less battery power than, say, sending and receiving radiofrequency waves).

Abbott’s Aveir DR duel-chamber pacemaker system with a AAA battery for size comparison. The shorter Aveir AR paces the atrium, the longer Aveir VR the ventricle. They synchronize their actions via a proprietary, low-power communications protocol. Image courtesy of Abbott.
Abbott’s Aveir DR duel-chamber leadless pacemaker system with a AAA battery for size comparison. The shorter Aveir AR paces the atrium, the longer Aveir VR the ventricle. They synchronize their actions via a proprietary, low-power communications protocol. Image courtesy of Abbott.

Zipse has been implanting leadless pacemakers since 2016, when the U.S. Food and Drug Administration approved Medtronic’s Micra device, so using a catheter to implant a leadless pacemaker was familiar to him. The Aveir DR won FDA approval in June 2023. What’s new with it, Zipse says, is working with patients on the pros and cons of dual-chamber leadless versus traditional transvenous pacemakers with leads – wires – and then, during implantation for which he did specialized training, coming up with the precise Aveir implantation geometries to maximize pacing effectiveness while minimizing battery demand.

A litany of health emergencies

With Bloomfield, the benefits of going leadless were clear. Despite looking more youthful than his years, he has run a gamut of health issues, the most profound of them having involved a maximally invasive remedy. He suffered four heart attacks from 2006 to 2013, after which point his scarred heart was failing so quickly that it took a 2014 transplant to save him.

The heart of a 22-year-old donor halted the cardiac issues, but prostate cancer emerged in 2015, its treatment limited to radiation given the risks of chemotherapy so soon after transplant. In 2016, Bloomfield fought off organ rejection and cytomegalovirus (CMV), which involved a month of intravenous antivirals.

In March 2020, the electrical, heating, and cooling contractor then became the first serious COVID-19 case treated at Valley View Hospital in Glenwood Springs. He ended up on a ventilator at University of Colorado Hospital, narrowly surviving. Then came a 2021 brain hemorrhage at the Gypsum Costco after Bloomfield briefly blacked out and fell hard on the tile. He recovered from all that fully, only to have his new heart start to flutter (atrial fibrillation and ventricular tachycardia) and, more alarmingly, take periodic four-second breaks starting in late 2023.

Aveir dual-chamber leadless pacemakers have Richard Bloomfield back on his bike after some scary heart-rhythm problems. Photo by Brayden Bloomfield for UCHealth.
Aveir DR dual-chamber leadless pacemakers have Richard Bloomfield back on his bike after some scary heart-rhythm problems. Photo by Brayden Bloomfield for UCHealth.

“I was concerned, you know? What if I didn’t wake up in the morning because it just decided not to restart?” Bloomfield said.

Advantages of leadless pacemakers

Bloomfield needed a pacemaker and given the origins of his heat-rhythm issues, a dual-chamber solution was best (many arrhythmias can be solved with single-chamber options). Despite his medical history, one pressing reason to go leadless rested on Bloomfield having had two implanted transvenous defibrillators over the course of nine years prior to his heart transplant. Like transvenous pacemakers, defibrillators thread leads from a battery and control box implanted in the upper chest. The leads string through a subclavian vein and the superior vena cava and then into the heart.

But the leads can cause the veins to narrow, and that happened with Bloomfield, Zipse says. Implanting another transvenous pacemaker risked them getting blocked entirely, requiring a balloon stent procedure to open the veins back up. Add to that the risk of infection, which is higher with transvenous pacemakers – and higher yet given the immunosuppressive drugs Bloomfield has taken since his heart transplant. The dual-chamber Aveir presented the best solution, UCHealth cardiac electrophysiology nurse practitioner Emily Pascual and Zipse suggested to Bloomfield, and the patient agreed.

“We know the device works, and he was up for being on the front lines of a really compelling and paradigm-shifting technology,” Zipse said.

Depending on how often the devices must engage due to an irregular heartbeat they detect, Bloomfield can expect eight or more years of battery life from his leadless pacing system, Zipse says. Should one battery drain faster than the other, they’ll have to decide whether to change out one or both devices in another catheter-based procedure. It will be straightforward but will be more involved than the 30-minute replacement of a traditional transvenous pacemaker, whose batteries typically last more than a decade, Zipse says.

The future of pacemakers

Zipse says transvenous pacemakers aren’t going away anytime soon, but that leadless technology has real advantages. He envisions wireless charging or perhaps even internal charging that harnesses kinetic energy from heartbeats vastly improving battery life as the technology matures.

“The leads themselves are the Achilles heel of pacing and defibrillator systems, so I think the future of pacing most likely will be leadless, even if leadless options are not appropriate for everyone currently,” Zipse said.

By late April, he had implanted four more Aveir DR device sets, with more on tap, he says.

For Bloomfield, the disconcerting breaks his heart was taking, as well as other arrythmias, have ceased. He and wife Karla plan on being out hiking and biking when the snow melts. As the father of six, grandfather of eight, and great-grandfather of one winds down his contractor work, the devout Jehovah’s Witness has continued to keep busy volunteering at least 50 hours a month teaching the Bible from Gypsum to East Vail.

Despite his health challenges, Bloomfield says he lives by the maxim that “There is more happiness in giving then there is in receiving,” as he put it.

He’s grateful for his care team, even if he’s a tough grader.

“It’s always been the best – you know, on a scale of one to ten, like a nine, because nobody’s perfect,” Bloomfield said. “And the electrophysiology team? They’re like a nine-point-nine.”

About the author

Todd Neff has written hundreds of stories for University of Colorado Hospital and UCHealth. He covered science and the environment for the Daily Camera in Boulder, Colorado, and has taught narrative nonfiction at the University of Colorado, where he was a Ted Scripps Fellowship recipient in Environmental Journalism. He is author of “A Beard Cut Short,” a biography of a remarkable professor; “The Laser That’s Changing the World,” a history of lidar; and “From Jars to the Stars,” a history of Ball Aerospace.