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Revolution of the Pacemaker


February 2015

On the other end of the phone, Stephen Francaviglia, president of Greater Milwaukee South Aurora Health Care, sounds excited. "This really is a big deal for cardiac care," he says, "and if it works the way the studies have shown it will work, itís a huge leap forward. Iíd say this is more than a technological evolution, itís a revolution."

Francaviglia is talking about a breakthrough in cardiac care that took place last May at Aurora St. Lukeís Medical Center, when a wireless pacemaker was implanted in a patient for the first time in Wisconsin.

The device, known as the Nanostim, is being developed by St. Jude Medical, the same company that invented the worldís first implantable pacemaker in 1958. This newest version, in trial phase at hospitals in Canada, Europe and the U.S., is less than 10 percent the size of the original and weighs just 2 grams.

In Milwaukee, Dr. Imran Niazi, electrophysiologist at Aurora St. Lukeís Medical Center, was selected to be the principal investigator for the Wisconsin study. According to Niazi, "the device is about half the size of a womanís little finger and weighs about the same as two aspirin. It is so small that itís inserted into the heart, nonsurgically. For the patient, this means there is no incision, no stitches and very little risk of infection. Right now we are keeping patients overnight, but I think once it is standard practice patients will come in and out in three or four hours."

Unlike a standard pacemaker that is implanted under the chest and wired to the heart, the Nanostim is loaded onto the tip of a catheter and introduced through the leg and into the heart itself. Once in place, the device is screwed into the wall of the heart, and the screw acts as the conductor that sends the electrical signal to the heart. Like a standard pacemaker, the Nanostim has an estimated five-year battery life.

Francaviglia says the Nanostim is being used on patients who are not totally pacemaker dependent. "There are a lot of different kinds of pacemakers," he says. "Some people have a normal underlying sinus rhythm, but the heart slows down sometimes. It does not happen all the time, but when it does, they need a little kick to increase rhythm. They are not 100 percent pacemaker dependent. The Nanostim is there to provide backup and keep the heart beating at a certain, predetermined rate."

Niazi has implanted eight since May. He says so far the Nanostim has been a great success. "I am happy to report that all implants have been successful, there have been no complications since, and all are doing very well. I think it is just a matter of time before this becomes routine. When that will be depends on the FDA."


This story ran in the February 2015 issue of: