Southcoast Health physician implants world’s smallest pacemaker in patient

SURROUNDED BY HIS pacemaker surgical team, Dr. Arnoldas Giedrimas, center, holds the world’s smallest pacemaker between his forefinger and thumb. / COURTESY SOUTHCOAST HEALTH
SURROUNDED BY HIS pacemaker surgical team, Dr. Arnoldas Giedrimas, center, holds the world’s smallest pacemaker between his forefinger and thumb. / COURTESY SOUTHCOAST HEALTH

PROVIDENCE – Earlier this month, Dr. Arnoldas Giedrimas, a board-certified cardiologist and cardiac electrophysiologist with Southcoast Health, implanted the world’s smallest pacemaker in a patient at Charlton Memorial Hospital in Fall River, Southcoast Health reported.
Unlike traditional pacemakers, the Medtronic Micra Transcatheter Pacing System does not require cardiac wires – often called leads – or a surgical pocket underneath the skin to deliver the pacing therapy, Southcoast Health reported. The device, about the size of a very large vitamin, is delivered through a catheter – put into an open vein in the patient’s leg – and implanted directly into the heart. Pacemakers are surgically implanted medical devices that generate electrical impulses to treat stalled or irregular heartbeats. Worldwide, nearly 1 million people are implanted with pacemakers every year, the U.S. Food and Drug Administration reported in its press release announcing its April 2016 approval of the MICRA TPS, which is the first – and only – leadless pacemaker to be approved by the agency.
No other Rhode Island hospital is using the MICRA TPS; Jeremy Milner, a Care New England spokesperson, indicated that its physicians “are working towards this for early next year.”
However, Lifespan currently is unconvinced. David Levesque, a Lifespan spokesperson, said, in part, “The Cardiovascular Institute at Rhode Island, The Miriam and Newport hospitals … continue to assess the potential risks of leadless cardiac pacemaker technology. It is unclear if the benefits of leadless pacing outweigh those of well-established proven technologies currently in use. Definitive long-term safety and efficacy data are not available. We will continue to monitor and evaluate permanent leadless cardiac pacemaker technology and its potential clinical risk versus benefit.”
Only two other hospitals in Massachusetts ¬– Beth Israel Deaconess Medical Center and Brigham and Women’s Hospital, both in Boston – have implanted the MICRA TPS in patients.
“It’s a novel design that miniaturizes and gets rid of some of the complications of a traditional pacemaker,” Giedrimas told Providence Business News in a phone interview. Complications include risks of fracturing or breaking of the leads and blocked veins or infections around the leads, he said. The MICRA TPS is one-tenth the size of a traditional pacemaker.
Will this become the preferred “go-to” methodology to replace the traditional pacemaker?
“We don’t believe [so]; it’s another tool … another option that we can offer patients,” said Giedrimas. “At least for the near future, it will be for patients with higher risk of complications with a traditional pacemaker or where it’s difficult or impossible to implant a traditional pacemaker.”
While he will evaluate its applicability on a patient-by-patient basis, Giedrimas is excited by the MICRA TPS, as it represents a new era of change. While pacemakers have been available for some 50 years, Giedrimas said that changes in pacemaker technology had plateaued. “This is the beginning of a new type of single chamber device” to treat bradycardia, which is a slow or irregular heart rhythm. Untreated, bradycardia can lead to dizziness, fatigue, shortness of breath or even fainting spells, Southcoast Health reported, and a pacemaker is a common way to treat bradycardia by restoring the heart’s normal rhythm.
As with a traditional pacemaker implant, the surgery takes about an hour and the patient stays overnight in the hospital, Giedrimas said. Unlike a traditional pacemaker implantation, this implantation requires no surgical pocket in the upper chest area, which reduces infection risks and is cosmetically more attractive. Studies conducted before FDA approval showed that all the complications associated with this surgery were about half of those with a traditional pacemaker surgery, he said.
While the patient’s costs for this surgery are still being worked out by Medicare, Giedrimas said that the MICRA TPS is slightly more expensive than a traditional pacemaker but did not provide more specific information. The health care entity had planned to wait until February 2017 – when Medicare was expected to finalize payments on this new pacemaker – but this patient needed a leadless pacemaker and had no other options. Giedrimas lauded Southcoast Health for accomplishing everything – additional staff training, safety protocols, etc. – in an expedited time frame to help this patient.
A public relations spokesperson for Medtronic, based in Mounds View, Minn., declined to provide pacemakers’ pricing information, citing it as proprietary data.
In October 2016, media accounts reported that St. Jude’s Nanostim leadless cardiac pacemaker – a Medtronic competitor product – experienced seven reports of lost telemetry and heart pacing output. Thereafter, St. Jude, which is being acquired by Abbott Laboratories, notified physicians to stop implanting that pacemaker, which has been approved for use in Europe, and remains under FDA review, a St. Jude spokesperson said. Asked whether these problems with St. Jude’s Nanostim raise concerns about the Medtronic pacemaker, Giedrimas expressed confidence in the Medtronic pacemaker, citing its rigorous safety procedures and demonstrated successful outcomes.

No posts to display