When a patient needs a cardiac intervention, surgeons can choose to access the heart in one of two ways: open-heart surgery or a cardiac catheterization.
Open-heart surgery offers clear and direct access to the heart, but it also requires stopping the heart, draining the blood, and putting the patient on an external heart and lung machine. Catheterization—insertion of a thin, flexible tube through the patient’s groin and up into the still-beating heart—is less invasive. But it’s not suitable for very complicated situations, because it is hard to manipulate the heart tissue with catheter-based tools from such a far distance.
Both methods have been highly optimized, but each has its own risks, benefits and drawbacks. Wouldn’t it be nice if there were a way to directly access the heart and maintain normal heart function and blood flow while repairs are performed?
When the first fetal cardiac surgery was performed at Children’s Hospital Boston in 2001 – entering Jack Miller’s heart through his mother’s abdomen and opening blood flow – the world was stunned. But more than 60 years earlier, another operation was equally game-changing.
It was 1938, a time before heart-lung bypass, when ether and chloroform were only starting to be supplanted by more controllable anesthetics, when tinkering with the heart or even opening the chest were seen as dangerous and taboo.
Tinkering was what Robert E. Gross, chief surgical resident at The Children’s Hospital, liked to do. He was interested in a congenital heart condition known as patent ductus arteriosus, a passageway between the pulmonary artery and the aorta that’s supposed to close after birth — but doesn’t.
Four-year-old Alina Siman is being kept alive on a device that gained approval in the U.S. just two weeks ago. The Berlin Heart Group’s EXCOR, a ventricular assist device manufactured in Berlin, Germany, takes over the normal function of a heart by pumping blood directly to the pulmonary artery and into the lungs.
With FDA approval granted on December 16, the U.S. joins Europe and Canada in offering the device for children of all ages with end stage heart failure.
When we think about innovation, especially in health care, our thoughts often turn to the highly complex: new surgical procedures, new drugs, new devices or machines, etc.
But innovation in medicine and patient care doesn’t have to be complex. Sometimes it can be very simple. Like a hat.
Karen Sakakeeny has been a clinical nurse for more than 30 years, spending much of that time in the operating room. While doing a stint in cardiac surgery, she found herself thinking about ways to improve the rewarming process for infants undergoing open heart surgery.
Imagine: You’re a pediatric cardiologist who for years has worked on the design of a device that could revolutionize the treatment of a severe atrial arrhythmia. But while you can find a lot of assistance and advice for bringing devices for adults to market, you find little help for devices intended for infants and children. What can you do?
The U.S. Food and Drug Administration could be your best friend. Better known for its role in establishing and enforcing regulations for drug and device safety and information, the FDA is also an advocate, helping bring innovative devices for pediatric treatment into clinical practice. Pedro del Nido, chief of cardiac surgery at Children’s Hospital Boston, outlined the FDA’s advocacy role last week at the monthly Innovators’ Forum hosted by the Children’s Innovation Acceleration Program.
Move over, Ozzy Ozbourne. Next Wednesday, October 27th, Children’s neurologist-neuroscientist and TEDMED speaker Frances Jensen will compare and contrast the developing infant brain with the highly paradoxical teen brain – which is also developing rapidly, all the way to age 25 or so. Infant and teen brains are at opposite ends of the developmental spectrum — almost different species, Jensen says – but they’re both extremely dynamic and exquisitely sensitive to environmental factors (drugs and alcohol in teens and brain injury and seizures in infants).