As the ratings show, for the most part the story follows best practices regarding potential harms and benefits, sourcing and context. The story veers toward the sensational with its second satisfied-patient anecdote. But taken as a whole the story provides a balanced picture of the device and its potential.
One thing bothers us – the story’s claim that the study data are "widely expected to lead the U.S. Food and Drug Administration to approve the new version of the pump" for chronic use–"possibly early next year."
It’s easy to get caught up in the enthusiasm of a device maker, excited physicians, "breakthrough" treatments and patients happy to be alive.
But it should never lead to prediction of approval. Any student of the FDA–or pharmaceutical stock prices–knows the agency’s decisions are uNPRedictable.
We urge journalists not to publish predictions, their own or others’, about whether and when a treatment will be approved.
As more Americans survive heart attacks, more of them deal with heart failure later on. A device that treats people with advanced chronic heart failure could prolong many lives. For now, whom to treat and when to treat with these devices remains an area of uncertainty.
The story states that the LVAD device costs $80,000, and that the total cost, including implant surgery, is over $150,000.
In the second paragraph the story explains that, according to the current study, 58 percent of patients receiving the Heartmate II survived for two years. The story does an excellent job comparing this outcome to that for heart transplant [70 percent alive after 10 years] and to an earlier version of the device [24 percent after two years].
The story implies the likelihood of death after two years–42 percent.
It also cites potential harms that include inability to monitor blood pressure and potential damage to brain, kidneys and other organs.
Yet the story fails to mention other harms that were described in the New England Journal study: stroke [18 percent], infection [35 percent], sepsis [36 percent], transfusions and surgeries for bleeding, and replacements. After implantation, patients were in the hospital for an average of 27 days.
These are not insignifiant risks of harm. The story earns a satisfactory under this criterion only barely.
The story describes the New England Journal of Medicine study only as a "200-person" study. But there was no other detail about how the study was conducted – and no evaluation of the quality of the evidence.
The story does not exaggerate the prevalence or severity of heart failure.
The story cites three medical sources; it reveals the financial connection between the first source and the maker of the Heartmate II device.
Presumably the two other sources have no conflicts of interest, but it would have been useful to state that.
The story compares the Heartmate II with earlier versions of the same device and with heart transplantation.
Because the story is about seriously ill patients for whom other treatments have failed, there is no need to describe the drug and lifestyle interventions used to manage heart failure.
It would have been useful, but not necessary, to mention other experimental surgeries and devices for advanced heart failure.
The story explains that the Heartmate II device is currently in limited use, to keep patients alive until a heart is available for transplant. The Heartmate II clearly is available only at advanced cardiac care centers.
Yet the story fails under this criterion because it stumbles across one of the most durable trip-wires on the field of health journalism: Predicting the device is "widely expected" to be approved for broader use, "possibly" early next year. This invites the reader to assume imminent wide availability.
The story does a good job by comparing the current device’s success rate to that of its predecessor.
It also makes clear that a device by another maker treats advanced heart failure–although we learn little about it beyond the fact that it’s used in Europe and unlikely [another inappropriate reporterly prediction] to be approved in the U.S. very soon.
There is no evidence that this story relied on a news release.