Strong points: appropriate caveats about the limitations of this early stage of testing, amplified by input from independent experts.
The population of Americans over age 65 years is increasing and along with it comes an increase in the numbers of people with heart rate irregularities. Pacemakers have become an important tool in the control of allowing people to live normal lives. A pacemaker implantation is performed under local anesthesia in a hospital by a surgeon assisted by a cardiologist. An insulated wire called a lead is inserted and guided through a large vein into one of the chambers of the heart. The leads are then attached to the pacemaker device, which is implanted under the skin of the patient’s chest. Although the procedure is relatively safe, there is a small risk of infection in the pocket that the pacemaker sits in under the skin, a risk of blood clots from the electrodes and a risk of infection from the electrodes. Pacemakers have become increasingly sophisticated over the years bt one of the liabilities is the use of the “insulated wire.” So, a pacemaker that does not requires electrodes would reduce their inherent risk. But, the new technology may bring additional risks to the table. Reporting on new technologies should not emphasize the “new” without giving context and comparisons with existing alternatives. Especially not after an early study in only 32 people.
The story explains that this is in the “early testing” phase, so it’s understandable that a cost estimate might not be given.
In the second paragraph, the story states that the cost is unknown.
And an independent expert postulated that “the new device will probably be more expensive than other pacemakers.”
The only mention of benefits was this: “The researchers reported positive results at up to three months.”
What does that mean?
The story explained that:
“researchers implanted the pacemaker in 32 people for the first time through a puncture in the skin; in 10 patients, they had to reposition it. …one patient died of a stroke while convalescing after suffering a heart injury during implantation and another had the pacemaker replaced with a defibrillator.”
One independent expert in the story said the new device “may pose special risks of its own.”
Another said, “When the battery of the implanted leadless pacemaker is exhausted, a new implant is necessary, with all the potential risks associated with this. It is not known if it will be feasible to safely retrieve the old device. If the old device is left in place, it is not known what the long-term effects of this will be.”
The story included enough appropriate cautions about the limitations of the evidence. For example:
“There are still many questions regarding the pacemaker. It’s only been implanted in a few dozen people who were studied for a matter of months, limiting information about its long-term use and safety. It’s also not clear when the pacemaker may be publicly available, and its cost is unknown. And the existing version of the device won’t work for most pacemaker patients because it lacks some key features.”
There was no disease-mongering in the story.
The independent experts who were quoted added important cautionary perspectives to the story.
And the story mentioned that the study author receives grant funding from the manufacturer, works for them as a consultant, and has received stock options from the company.
There are other wireless pacing devices being developed, yet the story offered no information about these alternatives, or how this new device might compare. What sets it apart? Why is this newsworthy?
In the second paragraph the story explains that “it’s not clear when the pacemaker may be publicly available.”
Even a quick online search shows that there are other wireless pacing devices in various stages of testing as well, yet the story makes no mention of these.
There was enough independent reporting to suggest that the story did not rely on a news release.