Over the years, advances in medical technology have spurred the development of many specialized devices to treat a range of heart-related problems. Devices can trap wayward blood clots, activate receptors that regulate blood pressure, or monitor and correct abnormal heart rhythms.
These sophisticated products are very dependable over all. However, unanticipated problems can occasionally arise — especially in pacemakers and implantable cardioverter-defibrillators (ICDs), which feature complex software and circuitry (see “Pacemakers vs. ICDs”).
Pacemakers vs. ICDs
Pacemakers and implantable cardioverter-defibrillators (ICDs) are small, battery-operated devices placed under the skin just below the collarbone. A pacemaker monitors your heart’s rhythm and, when necessary, generates a painless electrical impulse that triggers a heartbeat. ICDs work much like pacemakers, but they can also detect potentially life-threatening rapid heart rhythms and deliver a strong shock that jolts the heart back into a normal rhythm.
|
Recalls: Rare but relevant
Following reports of malfunctions, injuries, or deaths, the FDA issues recalls of faulty devices. Each year, Class 1 recalls (the most serious type) of cardiovascular devices affect thousands of people, according to a study published Sept. 17, 2024, in Annals of Internal Medicine. Among the 157 cardiovascular devices recalled from 2013 to 2022, nearly one-third were implantable devices, and a quarter were designated as life-sustaining or life-supporting.
If you’re among the millions of Americans who have an implanted heart device, what’s important to know? Dr. Daniel Kramer, a cardiologist at the Richard A. and Susan F. Smith Center for Outcomes Research at Harvard-affiliated Beth Israel Deaconess Medical Center, shared his insights.
“When you consider what pacemakers and ICDs do, it’s quite extraordinary. Both have to observe or generate some 100,000 heartbeats each day and respond within seconds to correct an abnormal heart rhythm,” says Dr. Kramer. “Whenever I implant a defibrillator, I make sure my patient understands that these are very sophisticated devices that work incredibly well, but they’re not perfect,” he says. Still, in any given year, well under 1% of people with either of these types of devices have any issues. Also, most recalled devices don’t need to be replaced. Often, the device can be reprogrammed from the outside. Other times, close monitoring is all that is required.
The challenge of testing cardiac devices
Before medications are approved by the FDA for widespread use, most are compared to a placebo or other therapy in multiple studies, including a least one major clinical trial involving thousands of people who are carefully monitored for one to four years.
But that’s just not possible with devices, says Dr. Kramer. First, it’s nearly impossible to do a blinded study, since people know if they’ve received a device. Second, it’s hard to convince people to agree to participate in a study where a coin toss determines whether they receive a device or not. (For some trials, everyone gets a device, but the coin toss determines whether the device is turned on.)
In addition, people who need heart devices are often older and have complex medical problems. “It’s difficult to ascribe any problematic outcomes to the device as opposed to the underlying disease,” Dr. Kramer explains. Finally, because complications are so rare, there’s virtually no amount of premarket testing that would allow researchers to predict and document those events, he adds.
But efforts are under way to improve postmarket tracking of device complications. The plan is to use electronic health records, Medicare databases, and registries developed in partnership with manufacturers to more carefully track patient experiences after they receive devices, says Dr. Kramer. “Going forward, I’m hopeful these updates will be meaningful for people who live with and depend on these devices,” he adds.
Take-home advice
If you have a cardiac device, keep a record of the make and model number, both on your phone and on a slip of paper in your purse or wallet, in case you ever have to go to an emergency department. Having this information handy will also let you easily check if the latest article about a device recall or warning applies to you.
If a device is recalled, the manufacturer will contact the device recipients and their doctors. So stay in touch with your primary doctor and the cardiologist who implanted your device. Make sure that both know how to reach you if there is a recall. If you move, or if you change your phone number or email address, let your doctors know.
link