more pictures of our life from instagram…
Dress up one morning before church
Boys playing piano together.
After his latest haircut… too short maybe?
Nice prank played on me and my friend Tammie.
Somebody stole my slow down sign and put it on top of her trailer.
Interesting article I just wanted to keep track of.
Littlest med-device patients are playing catch-up
There is no such thing as a baby pacemaker. Or a defibrillator for kids.
For children with an irregular heartbeat, the only option is an adult device. Pacemakers are wedged into children’s abdomens because there isn’t enough room in their chests. As their bodies grow, they face years of surgeries as the adult devices are replaced or modified.
The wave of medical device innovation that is improving and extending the lives of younger generations is passing over the youngest. While more patients in their 30s, 40s and 50s are benefiting from an extensive range of treatments, products are rarely developed with children in mind. Doctors must routinely alter devices to fit into kids’ bodies or wait until they are older to provide treatment.
“The biggest challenge, by far, is size,” said Dr. Christopher Carter, a pediatric cardiologist at Children’s Hospitals and Clinics of Minnesota. “But there are other issues as they get older: They aren’t going to be able to play contact sports. … Really, it becomes a lifetime of compromise.”
The scarcity of specialty devices for kids is largely a numbers game: There aren’t enough children with chronic illnesses to justify the cost of developing products just for them. Since most devices are developed in the private sector, companies such as St. Jude Medical and Medtronic spend their time on products that reach a broader population and ultimately return a profit.
“It can cost $100 million to bring a device to market,” said Dr. Steve Oesterle, Medtronic’s senior vice president for medicine and technology. “The market [for kids] just isn’t big enough.”
Children are noticeably absent from the development of treatments for pain, movement disorders and heart ailments — treatments that are helping tens of thousands in other age groups.
An estimated 1,600 children ages 1 through 17 in the United States had a procedure involving a pacemaker or a defibrillator in 2010, according to data from the U.S. Department of Health and Human Services. That compares with 56,033 patients ages 45 through 64 and 155,446 ages 65 through 84.
Kids also make up just a fraction of those receiving orthopedic treatments. Only 200 children had a procedure involving artificial hips in 2010; 188 received knee replacements.
Yet doctors and advocates say there are several technologies they are trying to develop with children in mind — and a few already are coming to market. Among them are defibrillators that don’t use wires to connect to the heart and tracheal tubes that won’t damage a baby’s esophagus during some procedures.
Such specialty devices also could prove more durable and efficient because they are a better fit. A smaller pacemaker, for instance, could further improve heart function in young children and be better secured in their bodies.
“The need is for a whole variety of low-tech and higher-tech devices that are optimized for kids,” said Donald Lombardi, who runs the Institute for Pediatric Innovation in Massachusetts. “It’s not rocket science to develop these things. But it takes good engineering — and an overall market.”
A group at the University of Michigan is trying to develop products aimed at kids. So are others at the University of California, San Francisco; Stanford University; and Atlanta Children’s Hospital.
All have won grants through the Office of Orphan Products Development, a program through the U.S. Food and Drug Administration (FDA) that seeks to nurture the development of medical products for patient populations of fewer than 200,000.
But most new devices, if they ever make it to market, are years away.
“It takes a lot of dedicated people and continuing to think outside the box to make things happen,” Lombardi said.
Little kids, big devices
ASHER THOMAS WAS 3 days old when doctors cracked open his chest to run the wires from his pacemaker to the outside of his heart. He was born with a condition called heart block, a problem with the electrical system that controls heartbeats.
His heart rate had plunged to 39 beats per minute. On the morning of his surgery, his anxious parents, Robyn and Aaron, couldn’t see him awake.
“His heart rate dropped so low that they had to sedate him,” Aaron Thomas said. “That was the scariest part.”
Asher went home from the hospital after spending eight days in neonatal intensive care. The pronounced bulge extending from Asher’s abdomen is a reminder of the adult pacemaker that he will need for the rest of his life.
“Once you’re a cardiac patient, you’re always a cardiac patient,” said Robyn Thomas.
Every three months, Robyn and Aaron hook their son’s pacemaker up to a telephone line at their Eden Prairie home so that doctors can see if it’s working properly. That’s the easy part. They know that every few years, Asher’s pacemaker will need to be replaced. They know that the wires that attach the device to his heart — the leads — come with risks.
“Kids are just tougher on leads,” said Dr. Charles Gornick of the Minneapolis Heart Institute.
Leads are known to last 15 to 20 years, but sometimes they wear out sooner, requiring a complicated surgery to replace them. Even if no hiccups occur, Asher eventually will have the leads run through a vein to his heart, which is how they are placed in adults.
There also are long-term effects of needing an implantable device. No one really knows what a lifetime of pacing does to the human heart.
“These things are not developed for children,” said Carter, Asher’s doctor. “We’re still learning.”
Then there are other difficulties. It can be tough to program devices to accurately sense when a child’s heart is dangerously out of rhythm because kids have naturally higher heart rates. Children are also harder on devices because they don’t always rein in their physical activities.
“It’s always an ongoing negotiation with our younger patients,” Carter said.
Fortunately, Asher, now 2, is proving to be as energetic and rambunctious as any little boy. He was walking at 10 months. He clambers up and down the carpeted stairs of his family’s home. He plays with puzzles and the family dog. Visits to the neighborhood playground are frequent and tiring — for his parents.
“He’s into everything,” Robyn Thomas said of her son. “He’s just busy. He’s always been busy.”
That overflowing energy is translating into high expectations for their little boy.
“My hope for him is that he can pretty much do what 99 percent of what his friends can do,” Aaron Thomas said.
A push for pediatric devices
SEVERAL CARDIAC DEVICES — pacemakers, heart valves and stents — got their start with children.
In the 1950s and ’60s, before FDA oversight, the first devices were used in an effort to save young heart patients before the technology was expanded to a broader population.
“Why is that? Because no one wants to see a kid die. I believe kids are the catalysts for imagination,” Medtronic’s Oesterle said.
But the way devices are developed has changed dramatically since then. In 1976, the FDA was given the responsibility of approving medical devices, which increased oversight. Where doctors once conducted research in backroom labs and tested devices with parents’ consent, the FDA now requires extensive testing and clinical trials for new devices.
Convincing device makers to do that for a costly product that might only help a handful of children is a nearly impossible sell, said Dr. Robert Campbell, a pediatric orthopedic surgeon and director of the Center for Thoracic Insufficiency Syndrome at the Children’s Hospital of Philadelphia.
Campbell has developed products for children, including a spine device that can be adjusted as a child grows, but it took 14 years to get it to market.
“I was very lucky,” he said. “I had a company that was owned privately and an owner that was very sympathetic to children.”
The two main areas of device adaptation for children are cardiovascular and orthopedic, said Brad Slaker, founder of DesignWise Medical, a Minnesota company that facilitates development of pediatric devices. Slaker calls those segments “low-hanging fruit” with moneymaking possibilities.
Otherwise, companies are reluctant to develop lifesaving or life-sustaining pediatric devices because they require expensive human testing. So potential pediatric devices, such as diabetes monitors for children, lack the profit margins that spur commercial research and development.
Slaker started DesignWise Medical to adapt adult devices for use in children and then to find corporate partners to mass produce and sell them. His company is working on a product called an “OPOD” that morphed an adult oxygen mask into a hood to treat children who need help breathing, but cannot tolerate a mask.
Child-specific medical devices also pose ethical issues. Researchers often struggle to find large enough pools of youngsters to make clinical trials statistically significant. Most parents are reluctant to volunteer their kids as guinea pigs in studies that could be necessary for better device evaluation.
For that reason, the FDA is working on new ways to derive pediatric uses from adult clinical trials, although nothing has happened yet.
“We’re trying to put out the word to industry about circumstances where we could take adult data and extrapolate it to the pediatric population to try to encourage … labeling products for pediatric use,” said Christy Foreman, director of the FDA’s Office of Device Evaluation.
A lifetime of choices
SOMETIMES, THE BIGGEST hurdle for young people with medical devices is learning how to live with them.
Katie Kobelinski, 29, is a nurse who works with younger heart patients at the Midwest Adult Congenital Cardiac Center in Minneapolis. It’s where adults with heart problems who were once youngsters with heart problems learn how to live a life filled with medication, battery changes and lifestyle modifications.
Most patients she sees are in their 20s, 30s and 40s. Her job is to persuade patients not to miss appointments or to skip medications — and to live within limitations.
The hardest thing for them is “coming to terms that something is wrong with your heart,” Kobelinski said. “We need to check their devices. They can’t fall off the face of the Earth.”
Kobelinski knows what they’re going through. She was born with a heart defect that has required six open-heart surgeries, and her aortic valve had to be replaced when she was a child. Scar tissue from those surgeries later interfered with her heart rhythm, requiring doctors to put in a pacemaker when she was 17.
Her aortic valve is from Little Canada-based St. Jude Medical and her pacemaker is from Fridley-based Medtronic.
Like all children with devices who will grow up to be adults with devices, Kobelinski has endured a lifetime of tough choices.
As a teen, it meant that she played tennis instead of higher-impact sports. It also meant shopping for a prom dress that was not only pretty, but that would hide her scars and pacemaker lump.
And it meant getting a letter two weeks before her wedding saying that her pacemaker lead needed to be replaced. She waited months to do it; she wanted a more normal start to her marriage.
It also has meant making the decision to not have children. She doesn’t want to pass along the risk of heart disease to her baby.
Kobelinski hopes technology for the next generation of children will allow them to live longer, better lives. She wants smaller devices that won’t wear out, leads that don’t break and batteries that don’t need to be replaced as often.
Kobelinski knows such advances would also benefit her own health.
“I don’t want to have more surgeries,” she said.
Kobelinski is optimistic. Lifting weights and walking have strengthened her heart to the point where it relies less on the pacemaker. She can do more than she once could with her husband, Mike, who cross-country skis and bicycles. They even hope to adopt a baby.
But her top goal in life is a simple one.
“I want to be old with him,” she said. “Whatever needs to happen to get there, that’s what I want.”
Star Tribune staff writers Jim Spencer and Glenn Howatt contributed to this report.
James Walsh • 612-673-7428
Think he’s ready to cheer on his favorite team. Guess what night it is?! White out. Good luck Aggies.
p.s. ..love the fall colors
Finally, I ventured far away from home with Hank. My mom and I took the 2 boys to visit my sister Leslie in Virginia. There was definitely a lot of prep involved to get all of Hank’s stuff on an airplane, but I got it done. I did learn a lesson though: no air travel without Steve (at least while Hank is on oxygen). That was tough work. I hauled my camera all the way out there, but guess what?! I never even used it. Sad. Good thing for these high tech cell phones we have nowadays.
Plane trip. The boys were amazing.
Spent a lot of time just playing at Leslie’s house. It was a great break.
Our numbers looked great at sea level (top is his oxygen saturation)
Got to experience our first Wiggles concert. Definitely will do it again.
Plane trip home.
Starving after the flight.
New glasses waiting when we got home. Definitely needed.
Drew is at the stage where he says so much funny stuff and it’s hard to keep track of. So, I usually save it in my phone when I remember, and then try to update later.
Drew is really outgoing for the most part. He likes to meet other kids and talk to people. Awhile back, we were at an Aggie game. Drew saw a little girl and wanted to talk with her. He ran right up to her and asked her what her name was. She responded appropriately. Then Drew stated “I’m buzz lightyear” in an attempt to impress her. Needless to say, she wasn’t.
One of Drew’s favorite places to go is to WalMart. Well, whenever we go, he has some new quip that he yells or says to people as we are shopping. Here they are:
Whenever we check out, he says to the checkers as he unloads our cart, “hi, how are you doing today?” Usually catches them off guard.
He runs by people shopping in the store and yells (really yells), “see ya sucker”
If he feels people are in his way he will tell them “Excuse me please, get out of my space”. We are working on being polite.
When people are shopping behind us in the isles, he will turn around in the cart and and yell at them to “stop following me”
I took the boys to get their flu shots last week. Drew did great. He only cried for a second. Afterwards, he insisted that he didn’t have a shot, but it was the band-aid they put on his leg that had hurt him.
Drew loves to cheer for the aggies. Right now in football, he’s quite interested. The aggies have a great quarterback right now and when he cheers for him, he yells, “go Animal”
Whenever I ask Drew if he wants a piece of cheese he gets very upset. “not a piece, a whole cheese”
Famous Drew quotes:
“hell sol” instead of El Sol a restaurant we eat at.
“Neglos” – he means legos but can’t seem to get it right.
“Giant coke makes me crazy” – referring to Diet Coke
“I can see” – while at the eye doctor trying out his new glasses prescription
I got my two boys matching shirts and shoes, fixed their hair, and took them outside for a quick jaunt with the camera the other morning. I was hoping to get some awesome pictures of two perfect little boys, smiling, and posing just the way I wanted. Instead, I’m pretty sure I got a preview of my next 15 years. Please. Wish me luck.
Attempt #1
Reset and attempt #2
ps… if you are thinking Drew looks like he’s enjoying this. believe it.
don’t worry about Hank. he got away.
Okay, maybe we could do better on the grass.
nope that didn’t work either. lots of dragging and crying.
still smiling.
It’s been a few weeks since we got home from our last cabin trip. It was a great get away after a stressful week. Why was our week a bit stressful you ask? Well, it was just super busy. Mom and Dad finally sold their house. But since they can’t live at the cabin, they needed a place to stay until their other house is built. So, they moved in. We were busy getting everyone settled. Plus, Hank had two doctors appointments that week.
Some of our adventures in Montana…
Hank was at the cabin too, in case you were wondering.
At Hank’s last cardiology appointment they made a big leap with his pacemaker. They turned him from 100 to 80 for his resting heart rate. I was a bit surprised about the jump but assumed it was what he needed. Plus, conserving battery life in his pacemaker is a priority for him since he’s 100% paced (meaning he has no heart rate that kicks in, it’s just too low). Since his appointment we had noticed that he was having a hard time keeping his oxygen saturations up. His normal was on 3/4 to 1 liter of flow he would have numbers in the 94-98% range. When we go to the cabin, we can usually keep those numbers up around 2-2.5 liters. We went to the cabin after his appointment, then we came home, but we were unable to keep his numbers up with his normal flow. Weird. I thought maybe he just had to get adjusted to the new rate. I checked with cardiology just in case… they said his change shouldn’t effect his lung function. So, we went on another week. At 2.5 liters, he could barely keep his levels above 90. So I put in a call to pulmonology. In the meantime this happened.
Can you see it? Drew got an awesome spider bite on his leg that turned into a lovely cellulitis. Thank heaven for the great guys at work who helped me out because I was supposed to be at the hospital for work, not for my 3 year old. After a week plus of antibiotics, he is much better.
Anyway, later in the day, I heard back from pulmonology. I was advised to take Hank in for a chest x-ray with the pediatrician, because really, it was agreed by our pulmunologist that Hank’s heart rate change shouldn’t effect his lung function that much. Long story shorter, x-ray was clear, whew. Cardiology called. Arrangements were made for St. Jude Rep (pacer rep) to come to Logan and turn Hank’s rate up to 90 bpm. The next morning, Hank’s rate was changed and there was immediate results. We could turn his oxygen flow down to his normal and get great numbers. What a relief. That kid wants to do everything his way.
Found this on facebook
Oh, one more thing. Check out this amazing quilt block that was made and dedicated to Hank. It was made by the awesome people who work with the Congenital Heart Defect (CHD) Awareness Quilt Project. Read about their amazing organization here. Hank’s block will be on a quilt with other adults and children with CHD and displayed around the country to spread awareness about CHD.
(CCHB – Congenital Complete Heart Block)
