By AMERICAN HEART ASSOCIATION NEWS
She was born with her heart on the right side of her chest instead of the left. It wasn’t connected to her lungs. Her heart also didn’t develop properly: the two pumping chambers were reversed and there was a hole between them.
Now 26, the Seattle native is preparing for her twentieth surgery, this time to place a biventricular pacemaker that will help her heart function more efficiently. But before operating, Sutton’s doctors wanted a more detailed understanding of her unique heart anatomy than what they could glean from two-dimensional images on a computer screen.
So last fall, doctors made an exact replica of Sutton’s heart using a three-dimensional printer. After several months of practice, doctors scheduled her surgery for March 30.
“They found a lot of ways that it doesn’t work, but a few ways that it does,” said Sutton, a grassroots coordinator for the American Heart Association’s Western States affiliate. “It’s huge to know they’ve had hands-on experience going from every different direction, and they have multiple plans in place ahead of time.”
At the American College of Cardiology’s recent annual meeting, 3-D “bioprinting” was among the new innovations highlighted during more than a dozen sessions on the future of cardiovascular medicine that covered everything from genomics to social media. It was the first time the medical society had offered such a program at its conference.
“We wanted to start to spur people’s minds a bit, moving to where the puck will be and thinking about how we might start to change our practice and our research,” said conference chair Athena Poppas, M.D., director of cardiovascular imaging at the Cardiovascular Institute at Rhode Island, The Miriam and Newport hospitals.
Some 3-D printouts are already being used in U.S. patients for knee and cranial implants. A Utah baby received 3-D-printed splints in 2013 to hold open a defective windpipe following emergency approval from the Food and Drug Administration. Doctors in some hospitals are also using 3-D printing to test-fit prosthetic heart valves before surgery.
Currently, 3-D printers build structures layer by layer using materials such as plastics or ceramics. Sutton’s replica heart was made from a malleable material that is similar to heart tissue. One day, researchers hope to print replacement organs from living cells.
A handful of talks at the ACC conference focused specifically on mobile health, or mHealth. Such technologies are swiftly entering the marketplace and the healthcare system must now catch up, said Sanjeev Bhavnani, M.D., a cardiologist and mobile health researcher at Scripps Health in La Jolla, California.
“The development is so far out, but yet our healthcare model is so far behind,” he said. “We’re looking to marry them together, but not quite yet knowing how that’s done. It will take creative methods in trial design and patient engagement for mobile health to prove effective.”
More than 100,000 health apps were listed in the iTunes and Google Play stores as of early 2015, according to research2guidance, a mobile market research company.
The Food and Drug Administration has so far cleared about 100 mobile medical apps, some of which work with wearable or handheld sensors.
In January, for example, the FDA approved an app that communicates with a hair’s-width sensor under the skin that measures blood glucose levels every five minutes in diabetics. Another, the AliveCor heart monitor, is a smartphone case that tracks a person’s heart rhythm through the fingers or chest. The generated electrocardiogram can then be stored on the app and shared with a doctor.
For cardiologist Elliott Antman, M.D., of Brigham and Women’s Hospital in Boston, the technology has allowed him to better diagnose problems in patients who have sporadic palpitations.
“It can be very difficult to figure out what it is because by the time they see me, they’re feeling fine and their heart rhythm is normal,” said Antman, president of the American Heart Association and a professor at Harvard Medical School. Having precise data about what is happening with patients in the real world in real time is invaluable, he said.
As for who is paying for the new gadgets, it is often the patient. The glucose monitoring sensor is not currently covered by Medicare, according to its San Diego-based manufacturer Dexcom. And although the AliveCor device is not covered by insurance, consumers can use their health savings account or flexible spending account to pay for the device, which costs less than $100, according to the manufacturer’s website.
In response to the proliferation of mobile health technology, the FDA in February released new guidance for developers about the regulation of mobile medical apps, replacing an earlier version from 2013. The guidelines said the agency would regulate only those apps that meet the definition of a medical device — something used to prevent, diagnose or treat a medical condition.
The onus is now on researchers to prove which mobile health technologies can actually improve patient care and possibly even reduce healthcare costs, said Jeffrey Kuvin, M.D., of Tufts Medical Center, who co-chaired one of the forward-looking sessions at the ACC meeting earlier this month.
Such studies are already underway. In California, Bhavnani is leading a study that looks at tiny computer chips embedded in pills that inform him when heart failure patients have taken their medications.
Medication adherence is a big problem in health care, with studies finding that up to half of patients do not take their medications, said George Savage, M.D., co-founder and chief medical officer of Proteus Digital Health, the company that makes the ingestible chip and accompanying sensor patch, both approved by the FDA.
Proteus is working with drug companies such as Novartis to develop and commercialize so-called digital medicines.
Kuvin noted that once enough evidence accumulates on the safety and efficacy of these products, medical groups such as ACC may offer some sort of criteria to help patients choose the ones most likely to benefit them.
For now, heart patients should talk to their doctor about wearables and apps that may aid in their treatment and overall health, said Antman. He pointed to his own wearable device that counts his steps and calories burned.
“Patients need to talk to their physician about how that information can be helpful in guiding their care,” said Antman. As more patients generate their own health data, “they will move from a more passive role to a partner role,” he said.
The American Heart Association does not endorse the products or companies discussed in this article.