Bob Icenogle spent the last five years living with a serious heart problem that could trigger a stroke at any time.
Atrial fibrillation, also known as A-fib, can cause blood clots to form in a tiny pouch in the heart. If a clot migrates out into the bloodstream, it could become lodged in a vessel and cut off blood flow to the brain.
To lower the risk, doctors usually put A-fib patients on blood-thinning medication for life so clots are less likely to form. But Icenogle, who lives in Ruskin, can't take blood thinners long term. He found that out after starting on the medication, and over time developed such severe internal bleeding that he needed transfusions. He tried other nondrug procedures, but none controlled the A-fib.
Then late last year, one of his doctors told him about the Watchman, a new device approved by the Food and Drug Administration in 2015. It looks like a miniature umbrella and is placed in the heart with a catheter threaded through a small puncture in the groin. The umbrella is opened and tissue eventually grows around it, closing off the pouch, which is known as the left atrial appendage. Doctors say we can live without it.
Atrial fibrillation is an electrical problem in the heart where the upper and lower chambers don't work together properly, causing the organ to sometimes fibrillate or quiver rapidly and irregularly. Because blood isn't being pumped normally, it can pool in the left atrial appendage, where clots can form and cause a stroke.
It may or may not cause symptoms, which include fatigue, palpitations, dizziness, shortness of breath and confusion.
According to the American Heart Association, 15 to 20 percent of all strokes occur in people with A-fib, and nearly 3 million people have the condition. In addition, strokes related to A-fib are more likely to be fatal or disabling.
Like Icenogle, many patients cannot tolerate the blood-thinning drugs that address the clotting. The treatment requires frequent blood testing and physician visits, dietary changes and can cause skin bruising and other serious complications, including the internal bleeding that Icenogle experienced.
A 69-year-old small business owner, Icenogle says there aren't many things he fears. But stroke is one of them.
"I'm scared to death of a stroke," he said, noting that he's seen how disabling it can be. "I don't believe that I, mentally, could survive a stroke."
So last month, a team at Tampa General Hospital implanted his Watchman, a first for the hospital.
Not all A-fib patients will be candidates. "We decide which (A-fib) patients are at highest risk for stroke, and if they can't tolerate blood thinners they may be a candidate for the Watchman," said Dr. Bengt Herweg, director of electrophysiology and arrhythmia at the USF Health Morsani College of Medicine. Herweg also was part of the TGH team that implanted Icenogle.
As a precaution, Watchman patients — Icenogle included — must be able to take a blood thinner for about 45 days after the operation to be certain the device is doing its job. After that, most will no longer need it. "It's another good tool in our cardiology tool chest," Herweg said.
Manufactured by Boston Scientific, the Watchman received FDA approval in March of last year.
Locally, Northside Hospital in St. Petersburg launched its program in July and has implanted 21 patients. Florida Hospital Tampa started early last month and has implanted four, with two more scheduled this month. Regional Medical Center Bayonet Point recently implanted its first patient.
St. Joseph's Hospital in Tampa participated in early clinical trials for the device and hopes to begin offering it in the next few months along with another BayCare facility, Morton Plant Hospital in Clearwater.
"We're very interested. I have a waiting list of patients who are candidates," said Dr. James Irwin, co-director of the electrophysiology lab at St. Joseph's. "The device now comes in a couple of different sizes so we can implant more people than we could during the clinical trial."
Icenogle believes his body feels different since getting his Watchman.
"I'm not short of breath anymore, I feel stronger, I can work longer. Before, some days I was just frazzled by two 2 o'clock and couldn't go any further. I'd get winded just talking to you," he said.
Now he's ready to expand his RV storage business and maybe one day really retire. He says he's already tried three times.
Contact Irene Maher at firstname.lastname@example.org.