Thomas Winner already had notable experience as a medical guinea pig.
The retired physical therapist said he received a test polio vaccine from Jonas Salk himself in 1954 at the D.T. Watson Home for Crippled Children in Bell Acres, where he was a student physical therapist. The home is famous as an early test site for the Salk vaccine.
His second time as a test subject occurred more recently.
In April, Mr. Winner, 87, of Shaler, underwent left knee-replacement surgery and was undergoing physical rehabilitation when it was determined he had low electrolytes at UPMC East. He said he felt no symptoms. But one morning in the hospital, while in bed talking to a nurse, his heart stopped for six seconds. Then at midnight, he awakened to find nurses gathered around him because his heart had stopped once again, this time for seven seconds.
The heart-rhythm problems were unexpected, despite previous heart procedures including angioplasty and implantation of an arterial stent.
Soon after, UPMC cardiologist Andrew Voigt, who specializes in heart-rhythm disorders, suggested that Mr. Winner undergo a procedure to have a newly developed pacemaker implanted into his heart to resolve his problem.
And shortly thereafter, Mr. Winner became the first Pennsylvanian and among the first 10 nationwide to have the “Medtronic Micra Transcatheter Pacing System” implanted inside the right ventricle of his heart.
Dr. Voigt, director of invasive electrophysiology at UPMC Shadyside, is participating in a nationwide human clinical trial -- also part of a global trial -- to test the effectiveness and safety of the new technology, which will determine whether the U.S. Food and Drug Administration approves the pacemaker for general use.
In the global trial, Medtronic expects to have the device implanted in 720 patients, said Joey Lomicky, a Medtronic spokesman. So far, he said, the pacemaker is functioning as expected and the company expects some results on the trial in coming months.
Voigt said he more recently implanted the device successfully in a second local patient.
Pacemakers, in use since 1958, treat bradycardia, or a heart rate of 60 beats a minute or slower, as well as irregular heart rhythm. Typically the problem is caused by degeneration of electrical conduction from the heart node, which produces an electrical impulse to cause the heart muscle to beat.
Currently used pacemakers have a cap holding the battery and electronics weighing about an ounce that is surgically placed under the skin in the chest with a lead, or wire, extending into the heart. The device provides a weak electrical impulse to restore a normal heart rhythm when the device detects problems.
The disadvantages include surgery and the raised area of skin in the chest. Dr. Voigt also said the most common malfunction in current pacemaker technology occurs in the leads.
"The lead-less pacemaker is revolutionary“ he said, noting there’s no need for surgery, which can cause infection, because the lead is eliminated in the new Medtronic device.
”It’s implanted with no incision with a catheter through the vein in the groin into the right ventricle of the heart with tines on the tip to secure it to the heart muscle,“ he said. The National Heart, Lung and Blood Institute says ”cardiac catheterizations rarely cause serious complications.“
The pellet-shaped Medtronic pacemaker is one-fifth the size of a AAA battery and weighs a mere 2 grams.
The tiny, wireless or lead-less pellet is designed to operate for 10 years, on average, thanks to miniaturized and simplified technology, and the long-lasting lithium battery incorporated into its shell. Doctors can monitor function with a wand placed over the chest.
Seven years ago, Medtronic started from scratch to produce the pellet-sized pacemaker that can be implanted directly into the heart muscle without surgery.
If the new Medtronic device has to be replaced, the person would undergo another catheterization, during which the old one can be withdrawn and a new one implanted. But the device is so small it can be left in place without any impact on heart function.
”We don’t anticipate removing the devices,“ Dr. Voigt said.
Mr. Winner actually did take some time to consider whether to undergo the experimental procedure, including discussing the idea with his own cardiologist.
But the Medtronic device held key advantages.
A traditional pacemaker in the chest would greatly limit use of the left arm during rehabilitation of his knee. He also would have to undergo another surgical procedure. Those factors prompted his decision to participate.
”Everything is going well, and I hope it continues to go well,“ Mr. Winner said. ”It’s always a joy to be with Dr. Voigt.“
Mr. Winner continues undergoing in-home rehab for his knee and has resumed driving with anticipation of traveling once again to Florida, Philadelphia, St. Paul, Minn., and the Cincinnati area to visit his two sons and four daughters, and their families.
"I hope other people can benefit from this, so I certainly am happy to be a pioneer,” Mr. Winner said.
David Templeton: firstname.lastname@example.org or 412-263-1578.