Lisa Callis Williams, 35, is no stranger to
In this inherited condition, the thickening of the muscular wall of the heart can cause a lethally irregular heartbeat, or arrhythmia. It's what caused Williams' 10 year-old-brother to drop dead in front of her while they were playing in the yard together when she was nine years old.
After her diagnosis at age 28, in 2005, Williams received the standard treatment — an implanted defibrillator with leads threaded through the veins into her heart to deliver an electric shock, as necessary, to regulate her heartbeat. She endured a slew of complications from the leads.
Then, in October 2010, just as she was planning to have the apparatus removed, Williams learned about Cameron Health's S-ICD System, the worlds' first subcutaneous implantable defibrillator without leads. She asked her doctors if she would be eligible for it. She duly became the first person locally to enroll in the recently completed clinical trial for the device. "It's much less invasive," says Williams, whose quality of life has improved dramatically with it.
The study's positive findings were presented May 10 at a medical convention in Boston. It's estimated that 850,000 Americans are at risk for sudden cardiac death, an electrical malfunction of the heart, and would benefit from such a tool. A
In all, 19 of the study's 300 subjects enrolled through
"Both the study and the device fit very well with how we do things here," says Herre, who also worked with Bardy on a groundbreaking heart study for the
Before trying the S-ICD System, Williams received unnecessary shocks, which doctors dubbed "inappropriate therapy," from her implanted defibrillator. She also developed blood-flow issues from the leads in her veins, and had to have procedures to open them. She was on blood thinners and other medications that caused unpleasant side effects and her activities were restricted accordingly.
Now, after 18 months testing the new defibrillator, the Virginia Beach resident is off all medications and can even jog on the beach. She has resumed yoga, including doing inverted poses, and she no longer has to sleep propped up on three pillows. "My reality was to have all these issues," says the mother of two teens. "I can do things I couldn't do before."
Williams is anxious to promote awareness of the new device to young people. "I want to make sure it's available," she says. Its benefits extend to its placement, under the skin on the lateral sidewall of the rib cage, "sort of under your arm," where it's virtually unnoticeable, and its easy implantation and removal. "I need it my whole life. It will have to be replaced every 5 to 7 years; I didn't want to go through pulling a wire from my heart," she says. Only its larger size took some getting used to.
That should change as it's readied for sale, says Herre, who also touts its benefits for younger patients. "It needs to get smaller. It's very attractive to have something that's easy to put in and take out and still preserves all the veins," he says. By the terms of the trial, he'll continue to monitor participants until October 2015, which will allow more time for any potential problems to become apparent.
Meanwhile, Williams is reveling in the lack of complications. "I was just really fortunate that when I needed it, it was available, and right in my back yard — and with a team of surgeons that I really trust," she says.