Does a new device to help heart patients work and is it safe? There's been growing concern about the safety and effectiveness of some medical devices in the United States once they're approved by the Food and Drug Administration.
To address those concerns, the FDA formed a partnership with researchers and a device manufacturer to monitor a newly approved heart valve.
Kris Wilson underwent a transcatheter aortic valve replacement at the Heart Hospital Baylor Plano. The valve is placed on a catheter with a balloon on the end.
At Baylor Plano, Cardiologist Dr. Michael J. Mack says, "rather than cutting out the old valve that's diseased, like we do in open heart surgery, we simply inflate the balloon and the old valve, with the calcium on it, is pushed out of the way."
It's a device that's used in elderly and frail patients who are either high risk for surgery or are not candidates for surgery.
After the FDA approved it, Dr. Mack says, the agency asked the American College of Cardiology and the Society of Thoracic Surgeons to help monitor the safety of the device.
Dr. Mack and his colleagues gathered results from a data base of patients who underwent this procedure at 224 sites around the country.
He says, "the procedure was successful in 92 percent of the patients and the number of patients that survived the procedure was about 95 percent."
The results appear in a theme issue on cardiovascular health in JAMA, the Journal of the American Medical Association.
"Two percent of patients suffered a stroke," Dr. Mack says. "Both the survival rate being so high and the stroke rate being so low is very self-assuring. The device was as safe there as it was in the randomized trials that resulted in the FDA approval of this device."
Kris, who has battled with heart trouble most of his life, is now looking forward to the important things like spending more time with his wife.