Considered at risk of sudden cardiac arrest, Francis Valek may someday need the life-saving jolt that an implanted cardioverter defibrillator (ICD) provides.
Trouble is, the 78-year-old from Farmington also receives dialysis three days a week, which increases his risk for infection. As a result, doctors concluded that Valek wasn't a good candidate for ICDs because of the devices' wires -- called leads -- that snake their way into the heart.
But what about an ICD without those wires?
At Abbott Northwestern Hospital in Minneapolis on Tuesday, Valek became the first Minnesotan to be implanted with Boston Scientific's subcutaneous implantable ICD (S-ICD) -- the world's first defibrillator that does not connect to the heart with wires. In fact, the device delivers its jolt without actually touching the heart at all. A lead runs beneath the skin from the device to just above the breastbone.
Officials at Boston Scientific Corp. say the S-ICD will not only attract patients who have not been able to benefit from such technology in the past because of complications; they think it will attract doctors and patients who have been scared off by problems associated with leads.
Leads that run through the vascular system into the heart have come under increasing scrutiny in the past few years. Short circuits caused by faulty wires have been associated with several deaths. Inner wires working through the outer insulation of St. Jude Medical's recalled Riata leads have raised fears that some ICDs will fail to deliver a shock to the heart when needed.
Dr. Charles Gornick, a heart rhythm specialist with the Minneapolis Heart Institute at Abbott Northwestern, has implanted more ICDs with leads than he can recall. For many patients, he said, ICDs with leads work just fine.
But leads, he said, have finite longevity. Leads can make people more susceptible to infection. Leads break. And for young patients who need heart rhythm devices, the prospect of removing faulty leads several times over their lifetime is a problem, he said.
"It's the leads that are the weak link over a long period of time," he said.
The Boston Scientific device avoids all of that. While it has limitations -- it cannot "pace" or regularly correct a faulty heart rhythm -- Gornick said it will be a good and increasingly popular option for younger patients and patients who need only a life-saving shock when the heart goes haywire.
"It does give Boston Scientific a unique product that no one else has," Gornick said. "It's not an answer for everybody. But it's another tool."
Another option for chronically ill
Nothing has slowed Valek, a father of six, grandfather of 11 and great-grandfather of seven. At one time, he worked as an operator for Koch Industries. Then, for 24 years before retiring, he operated equipment that digs holes for powerline poles.
Five years ago, kidney disease required that he get dialysis. About a year ago, heart disease further sapped his health. Doctors determined he needed an ICD. It turned out to be good timing.
In September, Boston Scientifc announced that the U.S. Food and Drug Administration approved its S-ICD -- meaning more options for people such as Valek. It also could mean up to $1 billion in revenue for Boston Scientific, which employs 5,000 workers in Minnesota, according to company estimates. It will be a slow start.
The device that Valek received Tuesday is the only one in the state. More will come as the company begins a phased launch that will expand as doctors are trained in its use. Boston Scientific acquired the S-ICD system earlier this year when it completed the acquisition of Cameron Health Inc., based in California.
The S-ICD has been available in many countries in Europe as well as in New Zealand. More than 1,400 devices have been implanted in patients around the world. Now, Minnesota -- and Valek -- can be added to the list.
The S-ICD features a sensing device and an electrode that are placed under the skin alongside the breastbone. It is not "leadless." Its wire runs through a "tunnel" Gornick created under the skin to the generator -- or "can" -- just beneath the skin near Valek's left armpit.
Before the procedure Tuesday, Valek, his wife, Delores, and daughter Sherie Wutschke traded smiles. Valek joked that it was probably his heart that "makes me lazy."
Still, he admitted that he was looking forward to feeling better.
"It's just that your heart is supposed to keep working," he said.
In a procedure that took only a couple of hours to complete -- in large part because Gornick did not have to navigate a pathway through veins into Valek's heart -- the doctors said the Farmington man's heart will have a better chance to do exactly that.
James Walsh • 612-673-7428