• New Heart Device Keeps Louisiana Outdoorsman in the Hunt


    Breathless in the Duck Blind

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    As he sat down in the duck blind in the chilly, misty Louisiana air waiting for the sun to rise, Tom Waters was tired and out of breath and his heart was beating fast.

    Must be because I lugged all that gear out to the blind, he thought.

    But it wasn't the first time he slumped into the duck blind early in the morning, tired, out of breath, heart racing. Over the last year or two, it had happened more and more. Usually once he got settled in the blind, his heart would return back to its normal rhythm and everything would be fine.

    Tom has always had something going. Whether it bush hogging, trimming trees, or driving tractors, he’s always maintained a busy, active lifestyle.

    "I just figured I was getting old," Tom said.

    A very active man, Tom loved to hunt ducks and whitetail deer and fish for bass and white perch. Three years after separating from active military duty in 1973, Tom and his wife, Sandy, moved back to live on the 80 acres of woods, water and farm in northeast Louisiana that he had inherited from his grandparents. There he ran a dirt, sand and gravel business, farmed Christmas trees,  drove tractors and trucks, operated heavy equipment, cut firewood, and worked in his workshop. He always had something going, whether it was bush hogging, trimming trees or planting sinker cypress for a home remodeling project.

    He was so busy he couldn't afford to have his heart go out on him. On that day in the blind, Tom's heart did return to normal. But there was a day coming when it wouldn't, not for hours.

    II. Sunday morning in the ER

    It was early on a Sunday morning. Sandy was at work at the West Carroll Memorial Hospital in Oak Grove, La., where she was a staff nurse. Tom was getting ready to attend services at the First United Pentecostal Church. He wasn't feeling right. His heart had started racing again.

    "I was the charge nurse on the medical-surgical floor when Tom showed up in the ER," Sandy said. "His heart rate was over 200." That's more than two or three times the normal 60 to 100 beats per minute.

    This time, his heart wouldn't convert back to normal.

    They sent Tom by ambulance to Glenwood Regional Medical Center in Monroe, La., about an hour's drive away. Minutes before he arrived, his heart converted back to a normal rhythm. He got checked out by a cardiologist, who kept him for a few hours then discharged him. Instead of driving more than an hour to go back home, Sandy decided they should spend the night at the hotel across the street from the hospital in case it came back. It didn't.

    But the ER visit got Tom's family's attention. They were worried about him. It was time to do something.

    "It was then I decided we have a problem," Sandy said.

    As a nurse, Sandy also knew that while his condition wasn't serious by itself, it could lead to the disease Americans fear most – stroke.1

    III. Atrial Fibrillation's Main Risk: Stroke

    Tom's doctors had determined that he had atrial fibrillation, a condition in which the upper chambers beat so fast they quiver. It's not uncommon for patients with atrial fibrillation to have several bouts before they even know they have it.

    In atrial fibrillation, Tom's blood was not efficiently pumped to the rest of the body. That's why he got tired and felt weak, especially if it went on for a while. Atrial fibrillation is becoming all too common: in 2010, atrial fibrillation affected 5.2 million Americans and it is projected to affect 12.1 million by 2030.2

    The condition can cause blood to pool and form clots in a small pouch at the top of the heart called the left atrial appendage (also referred to as LAA). If a clot forms, it can travel through an artery to the brain and cause a stroke. A stroke occurs when blood flow to the brain is blocked by a clot, depriving brain cells of oxygen.3

    Tom enjoys spending quality time with his grandchildren, Remington and Kensington. He is thankful to be able to share in memories with them that will now last a lifetime thanks to a catheter-delivered heart implant.

    "I've taken care of stroke victims, and that was a big part of my fear with his atrial fibrillation," Sandy said. She knew firsthand how devastating a stroke can be to patients and their families.

    If left untreated, about one in three people with atrial fibrillation will have an ischemic stroke, or a stroke caused by a blocked blood vessel.4 5 Ischemic strokes account for the majority of strokes overall,6 and one out of every five or six ischemic strokes is due to atrial fibrillation. They are often disabling or fatal.

    Time is critical in treating a stroke. The faster the patient is treated, the greater the chance that a stroke can be stopped, possibly saving the patient's life and preventing damage to the brain tissue that can result in disability.

    But sometimes those who are having a stroke do not recognize the symptoms, such as a drooping face, slurred or difficult speech and weakness in the arm.7

    Tom had the added challenge that he lived in a rural area. If he had a stroke, he was probably an hour away from the specialists best able to treat him. Worse, if Tom had a stroke while he was out by himself in the woods or on the farm, he might not be found until it was too late.

    IV. Blood thinners: Benefits and Risks

    Fortunately, there was a way to help prevent a stroke and control symptoms of atrial fibrillation – anti-coagulants or blood thinners.8

    Blood thinners help prevent blood from clotting and causing a stroke. For atrial fibrillation patients, blood thinners can cut the risk of stroke by more than half.9 Millions of heart patients are on blood thinners to help prevent heart attack, stroke and other serious conditions. Most people can take them safely for years without serious side effects.10

    But Tom found blood thinners hard to regulate – his blood would either be too thin or not thin enough.  He's hardly alone. As many as half of the people with atrial fibrillation who could benefit from a blood thinner don't take them because anticoagulants don't make them feel better and they can cause bleeding.11

    Blood thinners can pose real danger for some people due to bleeding complications or other side effects. By helping to prevent the blood from clotting, blood thinners can lead to excessive bleeding if the patient is cut or bruised. Blood thinners also can raise the risk for "hemorrhagic stroke," a stroke caused by bleeding into the brain, which is different from a stroke caused by a clot.12 Sometimes, people on blood thinners continue to bleed to the point where they need medical attention.13

    "We could never get the level established to where it needed to be," Tom said. "It would bottom out, then it would go way over where it was supposed to be. I was having some bruising and bleeding problems, too. I just wasn't comfortable on it."

    For most people, the risks associated with taking blood-thinner medications are less serious than the risks of having a stroke.14

    But for Tom, blood thinners were a threat to his life and his way of life.

    V. Dangerous Mix: An Active Life with Blood Thinners

    Tom always loved the outdoors, loved staying active. That was his way of life.

    Tom spent much of his childhood exploring the woods, fishing and hunting. His love for the outdoors was honed early by his grandparents.

    He largely grew up on his grandparents' 80 acres in northeast Louisiana, near the town of Oak Grove, which they acquired in the 1930s. He spent much of his boyhood exploring the woods, fishing and hunting on their land. That is, when he wasn't doing chores, such as repairing fences to keep in the cows his grandparents were raising.

    "Every week, Pap had me ride every foot of that fence on my horse and tighten up wire, replace staples, whatever had to be done," he said.

    Tom was in the U.S. Air Force during the Vietnam War. In addition to his day job as an operating sergeant in the 606 Special Operations Squadron, he flew 96 night combat missions, many of them launching magnesium flares out of a World War II era aircraft called the C123. The flares would light up the target for the bombers who would follow after them. After more than 20 years in the military, including spending the last 12 years as a recruiter for the Louisiana Army National Guard, Tom retired in 1997 at the rank of Sergeant First Class.

    Tom enjoys patching up old furniture in his workshop. In addition, he raises Christmas trees that he sells on his property.

    These days, he has a workshop on the property where he does some woodworking and patching up old furniture to sell at his sister-in-law's vintage shop. He raises Christmas trees, planted more than a decade ago, which he and Sandy sell on their property during the holiday season. He has three deer stands on the property, and a pond that has yielded some impressively sized bass. He operates a variety of heavy machinery, including a bull dozer, a tractor and a truck. When his church was building a new family life center, Tom hauled 40 loads of dirt as part of the project, Sandy said.

    "Tom is very active," Sandy said. "He likes to do whatever he wants."

    There was no way Tom wanted to end up as a couch potato.

    "I could see having to make lifestyle changes that I wasn't really willing to do," he said.

    Tom knew the risks. If he were off hunting in the woods when he got a bad cut or bruise, his thin blood would put him in danger of bleeding out.

    "I could end up feeding the trees," Tom said.

    VI. Hunting for Alternatives: The Clinical Trial

    Here is one of life's ironies: hunting, which put Tom at risk, helped him find a safer alternative.

    Tom's son Toby was a friend of, and sometimes worked as a hunting guide, for Dick Brown, who owns the 4B Ranch in Tallulah, La. Brown, who had heart troubles of his own, suggested to Toby that his father see a fellow 4B Ranch hunter, an interventional cardiologist in New Orleans. His name was J. Stephen Jenkins, MD, FSCAI, director of interventional cardiology research at the John Ochsner Heart and Vascular Institute.

    Dr. Jenkins came highly recommended:  Dick said he owed his life to Dr. Jenkins, Tom said.

    Dr. Jenkins was participating in a clinical trial to test a catheter-delivered heart implant designed to close the left atrial appendage, the little pouch in the heart where blood pooled and could clot during atrial fibrillation. The device does not treat atrial fibrillation, but it does help prevent stroke and enable patients to reduce their use of blood thinners.

    In 2007, Tom and Sandy went to New Orleans to meet with him. Dr. Jenkins interviewed Tom about his condition. In addition to his difficulty regulating blood thinners and handling the resulting bleeding risk, Dr. Jenkins said that Tom also had ulcerative colitis, a form of inflammatory bowel disease that causes swelling and sores on the colon, or large intestine. Blood thinners, or anti-coagulants, make it difficult for the sores to heal, he said.

    "He was an excellent candidate for the device, because it removed his need for anticoagulation," Dr. Jenkins said.

    Given Tom's lifestyle, not to mention his condition, getting off blood thinners was important for his health, Dr. Jenkins said. Tom "could literally bleed to death in a field after he was cut riding on his tractor," he said.

    Dr. Jenkins asked Tom if he would like to enroll in the trial, called PROTECT AF. He described the trial to Tom and Sandy as a multicenter, prospective randomized clinical trial that compared the left atrial appendage closure device to long-term warfarin (a blood thinner) therapy. That meant that patients would be randomly assigned to either the device arm of the trial or the control or blood thinner arm of the trial.

    Since it was an experimental procedure, Tom and Sandy had questions about its safety. Sandy talked to several trusted doctors at the hospital where she worked. They hadn't heard about it, but after they researched it, they told Sandy that it sounded like a promising device and procedure.

    Tom and Sandy weighed the good and the bad, the pluses and the minuses, and came to the conclusion that it was "just one of those things we had to do," she said.

    The question was: Would Tom get the device or the blood thinner?

    VII. "Amazing – that they could even do it!"

    Just one out of three patients in the trial was assigned to get the device rather than the blood thinners.

    Tom beat the odds and got the device.

    After traveling to Ochsner several times, including once to get an intravenous procedure to help determine the right size for the device, Tom was ready for the procedure.

    The procedure was performed intravenously, so Dr. Jenkins and his team watched what they were doing on a video screen.

    Stephen Jenkins, MD, FSCAI, director of interventional cardiology research at the John Ochsner Heart and Vascular Institute, came highly recommended to Tom. He and his team performed Tom’s procedure intravenously, allowing them to watch on a video screen.

    Dr. Jenkins made a small puncture in Tom's femoral artery in his groin. He inserted a catheter into the artery and threaded it up into the right atrium of Tom's heart. He used a small needle to cross the intra-atrial septum of Tom's heart and then inserted a catheter into a left atrial appendage on the left atrium of Tom's heart. Once the catheter was in position, the device – which is about the size of a quarter and as light as a feather – was positioned in his left atrial appendage. Like opening up a tiny umbrella, Dr. Jenkins deployed the device to fill the cavity in Tom's heart. Dr. Jenkins unscrewed a small cable that attached that left atrial appendage to the catheters and the devices were pulled out.

    Tom was out of the hospital the next day.

    When he came back for his first check up after the implant procedure, they used an ultrasound probe to look at the device.  They asked Tom if he would like to watch. Yes! he said.

     "Seeing the device was absolutely amazing – that they could even do it!" Tom said.

    Now, one question remained: Would the device work?

    VIII. Post-procedure: A Successful Trial

    After the device was placed, Tom had to stay on blood thinners for six weeks until his heart tissue grew over the implant. After six weeks, he stopped the blood thinners. Now all he takes is four baby aspirin a week.

    Later, Tom was diagnosed with an overactive thyroid condition that contributed to his atrial fibrillation. They successfully treated his thyroid condition with radioactive iodine.

    In 2015, Tom's device was approved by the U.S. Food and Drug Administration as a new stroke risk reduction option for high-risk patients with atrial fibrillation who seek an alternative to long-term warfarin therapy.15  

    "I'm thankful for people like Tom Waters who are willing to enroll in a clinical trial," Dr. Jenkins said. "Consider the many people who have benefitted from Tom's willingness to do that," he said.

    The procedure is becoming more and more common, Dr. Jenkins said, benefitting patients who have trouble with blood thinners.

    It's been nine years since Tom got the device. He is as healthy as ever. No stroke. No uncontrolled bleeding. And once his thyroid issue was treated, his atrial fibrillation has mostly gone away, too.

    "Now I can do what I want when I want to," Tom said.

    IX. The Playhouse: Tragedy Averted

    Tom's labor of love to build his granddaughter, Kensington, a playhouse could have ended in tragedy if he was still on blood thinners.

    One thing he was able to do was build a playhouse for his 6-year-old granddaughter, Kensington, who lives with her parents and brother in Waverly, La., about an hour's drive from Tom and Sandy's home.

    "She had wanted a tree house, but we finally talked her out of that," Tom said.

    In late March, Tom and a friend began to build the playhouse in the backyard of Kensington's home, which sits on a peninsula created by the Tensas River. They used rough-cut lumber, which they planed down. They built a lot of details into the playhouse, including windows that open and close, a small loft with a crescent window, a chandelier with a three-way switch, a porch with a light, and a metal roof. The playhouse, which sits on the banks of the Tensas, is tall enough for adults to stand inside – including his son and Kensington's father Toby, who stands at 6 foot 5.

    "It was a labor of love," Tom said. "We blew the budget in about three days."

    They made a sign for the outside of the playhouse: "Kensington's Palace."

    But this labor of love could have ended in tragedy had Tom still been on blood thinners.

    The first day, a large load of wood fell onto Tom's foot. Sandy was sure it was broken. They took Tom to the ER, where they found that his foot was badly bruised but not broken. If he had been on blood thinners, the incident would have been far more dangerous.

    Later in the building process, the table saw wouldn't go up and down as smoothly as it was supposed to. Tom climbed under it to see what was binding it, thinking it might need lubrication. The saw slipped and hit him.

    "It knocked a big hunk of hide off of the back of my hand," Tom said. "If I hadn't gotten the device and had been on blood thinners, God only knows what would have happened to me."

    X. Tom Tells Everybody

    Tom and Sandy look forward to celebrating their 50th wedding anniversary this December. They are most grateful for the quality of life they now have after Tom’s procedure.

    Tom and Sandy will celebrate their 50th wedding anniversary Dec. 16. One of the blessings that they count together is that they still have a good life together on their 80 acres.

    "Quality of life is so very important," Sandy said. "It's not how many days you have but how you live your days."

    And one reason this is true, they believe, is the device that Tom got nine years ago so.

    It's a story Tom loves to tell – to anyone who will listen, Sandy said.

    "We can be sitting at a restaurant somewhere and somehow it will come up," she said.

    Tom’s daily activities are a reminder of how the device has changed his life, his wife Sandy stated. Without the procedure, these activities would have put him at risk. Now he can do them without thinking twice.

    One time, for instance, Tom and Sandy were driving to New Orleans when they stopped in a restaurant in Jackson, Miss. Tom started talking to a man and woman at the next table, and discovered that the woman had atrial fibrillation. It wasn't long before he was recommending that she go see Dr. Jenkins to ask him about the device – especially now that it has been approved by regulators.

    "He tells everybody," Sandy said.

    "I consider Doc (Jenkins) a good friend," Tom said with emotion.

    His daily activities are a reminder of how the device has changed his life, Sandy said. Sitting in a blind waiting for the ducks to come in, watching for deer from one of his stands, repairing an old chair, hitting ground balls to his 11-year-old grandson Remington, trimming the Christmas trees, crafting a new wood ceiling for his breakfast nook at home: without the procedure, these activities could have put him at risk and been a source of worry for his wife and family. Now he can do them without thinking twice.

    "It's been a tremendous blessing," Tom said.

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