After two generations of battery-prodded hearts, thousands are left with faulty wiring.
This summer, the U.S. Food and Drug Administration (FDA) issued a public recall based on that reality. The targets were certain Medtronic Kappa and Sigma pacemakers.
About 21,000 patients were affected.
The FDA warned those with the recalled implants of symptoms ranging from abnormal heart rate to lightheadedness.
Joseph DeToia, 86, of White Plains, though personally unaffected by the Medtronic recall, has had his fair share of concerns with a similar device.
“I delivered pharmaceuticals to nursing homes and one day, I couldn”™t walk up the steps,” said the former U.S. Navy man. “I had to go in and the nurse asked me what was wrong. She said, ”˜You had better see a doctor right away.”™”
DeTaio went to Cardiology Consultants of Westchester and had a defibrillator installed 10 years ago.
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“Over the years, he”™s had some changes in the generator,” said Dr. Martin Cohen of Hawthorne-based Cardiology Consultants of Westchester, who recently performed an Excimer Laser procedure on DeToia. “The cardiac leads (wires) were the original leads and recently he developed an infection inside of the pocket where the device was, which necessitated removing the device and also removing the leads. If you don”™t remove the device and the leads, you can never cure the infection.”
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Cohen said the procedure is “relatively new” and involves a “sheath with a laser on it that slides over the leads and can disrupt any plaque, adhesions or scar tissue around the wire to allow us to pull out the whole wire.”
The laser works in the same manner in both pacemakers, which regulate a slow heart, and defibrillators, which slow down a dangerously fast heart.
Many wires last forever, Cohen said, “and a small number have a problem with the wires, but on average, we expect when we put a pacemaker in, that they”™re good forever.”
He said the device itself has a battery that wears out with time and anyone with a pacemaker or defibrillator expects to come back every few years to have the generator replaced.
Like this summer”™s recall, Medtronic issued another recall in 2007 after reports of fractures and inappropriate shocks in Sprint Fidelis leads occurred in patients.
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An overwhelming 235,000 patients were affected by the recall.
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Though the ultraviolet laser procedure is a solution for patients with infection, Cohen acknowledged “the alternative in someone who doesn”™t have an infection is to add new wires.”
But in patients like DeTaio, where infection or scar build-up has manifested, there really is no other alternative.
Cohen said it is a standard procedure, which is typically covered by insurance and Medicaid and takes about an hour and a half to complete.
The ultraviolet laser procedure is not limited to aging adults, either.
“It is actually becoming an issue for younger people, because now as congenital heart disease operations become more mainstream, even children can get them,” Cohen said.
Cardiology Consultants of Westchester operates affiliate offices in cities including: Carmel, Kingston, Mount Kisco, Port Jervis, Valhalla, New Paltz and New Windsor.
The practice services patients throughout the tri-state area.
