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Sunday, Dec 3, 2023

OC at Forefront of New Heart Pacemaker Tech

Two of Orange County’s biggest hospitals, Hoag Memorial Hospital Presbyterian and Providence St. Joseph, issued statements on the same day to tout successful implants of a new wireless pacemaker from Chicago’s Abbott Laboratories.

“Providence St. Joseph Hospital Implants First Dual Chamber Leadless Pacemaker on West Coast,” said a headline from a press release issued Nov. 7 by Providence St. Joseph Hospital in Orange.

Not so fast, according to a statement from Newport Beach’s Hoag.

“Hoag Among the First in the World to Successfully Implant Aveir DR,” said a Hoag announcement. “Hoag Memorial Hospital Presbyterian announced the successful implant of the world’s first dual chamber leadless pacemaker in a patient.”

The dueling press releases are about Abbott’s new dual chamber Aveir DR pacemaker, which the Food and Drug Administration approved in July.

Whether Hoag or St. Joseph was first is hard to say because they both started their surgeries at 6 a.m. on Nov. 6.

UCI Health, the county’s largest hospital, didn’t issue a press release but conducted its first single chamber Aveir implant on Oct. 25, according to Dr. David Donaldson, its director of Cardiac Electrophysiology.

All three hospitals were among the first to implement this new technology, according to Abbott officials.

“It’s not a race,” said Vish Charan, Abbott’s divisional vice president for product development, cardiac rhythm management. “We don’t want it to be a race. This is a medical procedure.”

The New Pacemaker

Approximately 3 million Americans live with pacemakers to treat a low or abnormal heart rhythm.

A typical pacemaker is implanted underneath the skin on a chest with wires about 20 inches to 26 inches long that are then attached to the heart chambers.

“The traditional pacemaker was pretty much unchanged since the 1950s,” Donaldson said. “It was a basis device.”

A heart that can beat 400 million times in a decade puts a lot of stress on many pacemakers, Charan noted. Malfunctions affect 1 in 6 patients who have standard dual chamber pacemakers.

“If there is ever a failure of the wire, you have to pull it out, which poses a very difficult problem,” Donaldson said. “The Abbott product is retrievable in a fairly straight forward process.”

The Aveir DR’s most prominent feature is the elimination of wires. Its two devices are about half the size of a AAA battery and about one-tenth the size of a traditional pacemaker.

They are implanted directly into the heart’s right atrium and right ventricle chambers through a minimally invasive procedure using a catheter inserted into the thigh. The DR stands for Dual Chamber Rate Responsive pacemaker.

The two devices can communicate wirelessly with each other through what Abbott says is “a first-of-its-kind implant-to-implant technology to establish continuous, synchronized pacing between the right atrium and the right ventricle.”

“It’s not like Bluetooth or Wi-Fi because those take a lot of power,” Charan said. “These devices have to last many years in the body.”

The devices attach to the heart’s interior surfaces with a screw-in mechanism that allows for future retrieval should therapy needs evolve or if it needs to be replaced. The devices last eight to 15 years.

Patients can return home the same day after the implant.

Charan, who leads the mechanical development of cardiac lead systems and power systems for Abbott’s Cardiac Rhythm Management business, works out of Abbot’s facility in Sylmar, which developed the Aveir along with other Abbott offices in Sunnyvale and Minneapolis.

“It’s been a fantastic week,” Charan said. “We’re really changing the world of cardiac technology.”

Abbott, which employs 110,000, generated $43.7 billion in sales last year and has a $161 billion market cap (NYSE: ABT). Its 100 employees at its Irvine facility rank it No. 24 on the Business Journal’s annual list of largest local medical device makers by local employee count.

Game Changer

Abbott advised the hospitals to issue their press releases on Nov. 7.

“This is truly a breakthrough with a technological advancement that’s like the difference between dial-up internet and high-speed Wi-Fi,” said Dr. Brian Kim, the cardiology and electrophysiology specialist with Providence St. Joseph Hospital who performed the procedure.

“With a majority of patients having the need for dual chamber control, and the increased longevity this new technology affords clinicians, more and younger patients will benefit from this game-changing device,” he added.

Providence St. Joseph Hospital is the fifth largest in Orange County, reporting $821 million in revenue for the year ended Sept. 30. It has about 3,200 employees.

Hoag is the second largest hospital with $1.4 billion in sales. It employs more than 8,000.
UCI Health is the largest hospital, with $1.6 billion in sales and 5,730 employees.

MemorialCare, which operates No. 8 Saddleback Medical Center in Laguna Hills and No. 9 Orange Coast Medical Center in Fountain Valley, plans to start using the device, a spokeswoman said.

Kaiser Permanente, the third-largest hospital in Orange County, isn’t using the device “at this time,” a spokeswoman said.

Hoag Angle

Hoag said its first minimally invasive surgery was a success and marks a “game changer” for cardiac patients.

“This technology expands access to the benefits of leadless pacemakers to far more people than ever before,” Hoag clinical cardiac electrophysiologist Dr. Rajesh Banker said in a statement.

“It also expands our abilities as clinicians to treat people with slow or abnormal heart rhythms.”

The new pacemaker allows for a “tailored, patient-centric approach” said Banker, explaining that a person who only needs an atrial or ventricular device at first can then be upgraded over time.

Hoag has prided itself on developing a system it calls “privademics” where doctors can participate in clinical trials in addition to their regular practices.

“Hoag’s ‘privademic’ focus continues to attract the nation’s brightest minds and most promising technology,” Hoag Chief Executive Robert Braithwaite said. “Offering the
new pacemaker at Hoag gives Orange County patients extraordinary access to this revolutionary technology.”

A ‘Big Moment’ for Heart Pacemakers

Dr. Rajesh Banker started working on the problem of wireless pacemakers a decade ago by first experimenting with animals.

When Abbott Laboratories began its trials, the Hoag clinical cardiac electrophysiologist was one of the lead investigators, performing all nine implants for the hospital.

He also taught other doctors in California, including Dr. David Donaldson, who has conducted the implant as UCI Health’s director of Cardiac Electrophysiology
Banker “is the grandfather” of training in California, Donaldson said.

Banker credits Dr. Matthew Fishler, who is chief engineer of the leadless pacemaker system portfolio at Abbott, with being the grandfather of the device. Time magazine has named the Aveir DR as one of the best inventions of 2023.

The device’s history dates to 2007 when a company called Nanostim started its research; the company was then bought for about $124 million in 2013 by St. Jude Medical, which in turn was acquired in 2017 by Abbott for $25 billion.

Rival Medtronic in 2016 unveiled its own leadless pacemaker, the Micra AV. However, that device works only in the ventricle chamber and not in the atrium chamber. About 80% of candidates need a pacemaker for both chambers and had to stay with wired pacemakers, Banker said.

The new Abbott devices can communicate with each other because “blood is a salt solution that can conduct electricity,” he said.

“It’s a massive technological hurdle that Abbott had to overcome,” Banker told the Business Journal. “It’s a big moment.”

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