With FDA approval, Irish implant jolts pacemaker field

Pace the nation: Medtronic's Micra AV could reset the U.S. pacemaker industry.
By GREGORY ZELLER //

For Northwell Health cardiac patients, the packages don’t come much smaller, nor the benefits much bigger.

Behold, the Micra AV – the world’s smallest atrioventricular synchrony-promoting pacemaker, based on a cutting-edge technology that virtually eliminates cutting and dances to a whole different beat.

Atrioventricular synchrony, of course, tracks electrical activity between the upper and lower chambers of the heart (atrial electrical activity above, followed by ventricular activity below).

Problems arise when those rhythms are off – perhaps the sinus node, the heart’s built-in pacemaker, isn’t firing off electrical impulses properly, or impulses are getting fritzed between the upper and lower chambers, and as a result, blood isn’t pumping between chambers, and out and about, as it should.

Hence, the pacemaker, which has long used electrical pulses to counter “heart block” and otherwise normalize heartbeats. It’s been an effective technology, if not particularly sleek – traditional pacemakers have involved surgical implants somewhere near the shoulder or collarbone, with wires running through the veins all the way to the heart, sending electrical impulses as necessary to the upper and lower chambers.

Laurence Epstein: Winning hearts (and minds).

Now comes the Micra AV, which shrinks the science down to size.

Not only is the next-generation device incredibly small – about one-tenth the size of a traditional pacemaker – but it incorporates a wholly different rhythm-regulation technology: “beat-to-beat” sensing that tracks actual mechanical activities in the heart chambers, as opposed to tracking those electric impulses and, essentially, emitting best-guess zaps.

The whole idea is to get the atrial and ventricular chambers beating in rhythm – and to that end, the tiny Micra AV plays huge, according to Laurence Epstein, director of electrophysiology for the Northwell Health system.

Epstein performed Northwell’s first two Micra AV procedures on Feb. 8 and Feb. 10 at the Sandra Atlas Bass Heart Hospital, inside Manhasset’s North Shore University Hospital – among the very first U.S. procedures since the U.S. Food & Drug Administration approved the device in January.

Micra AV, by Irish med-tech maker Medtronic, is “pill-sized,” according to the company, and perhaps it is, for the horse you rode in on. Still, it’s small enough to be implanted without an incision – the device is inserted through a catheter – and hooked (literally) into the heart with small, sharp tines.

That sounds painful but isn’t, and provides unprecedented advantages toward AV synchrony. Among them: that beat-to-beat technology, providing an up-close picture of actual heart conditions, and the elimination of wires running through the body, another old-school pacemaking mainstay.

And then there are the indisputable benefits of avoiding surgery – not to be overlooked, according to Epstein – and the physical discomfort of running electrical leads through the body.

“There’s the risk of infection at the surgical site,” Epstein told Innovate LI. “There’s a risk the wires are seeded with infection. The wires can move, or even break, and taking wires out down the road can be challenging.”

Micra AV’s predecessor Medtronic’s Micra VR, also leadless and relatively tiny but lacking the beat-to-beat breakthrough has been implanted in some 50,000 patients across 60 countries since earning 2016 approvals, according to the Dublin-based manufacturer.

After completing Northwell Health’s first two Micra AV procedures, Epstein believes the next-gen device is also destined for rapid deployment. Medtronic estimates that Micra AV could be applicable to up to half of all U.S. pacemaker patients and Epstein suggests the percentages could go even higher – Micra AV is designed to work on the lower ventricular chambers, and when Medtronic completes work on an anticipated atrial version, according to the doctor, virtually all pacemaker patients could be in line.

“This is remarkable for patients in so many ways,” Epstein noted. “There’s also the psychological advantage – every time someone (with a traditional pacemaker) looks in the mirror and sees the bump under their skin and sees the incision, there’s a reminder that something’s wrong.

“So, this gives a psychological advantage as well as a physical advantage,” he added. “The Micra AV is a real game-changer.”