Overall, this story does a good job of reporting that a continuous-flow heart assist device performed better than an older, pulsatile-flow model in selected patients with advanced heart disease who were not considered candidates for heart transplants. It highlights the cost as well as the potential benefits of the device. It clearly points out that the manufacturer of the device sponsored the study and that many of the researchers consult for it or other device makers.
However, the story may give readers an exaggerated sense of the value of this device by saying it could help “many older people with severe heart failure” without clearly describing the narrowly defined group of patients that was included in this trial. What’s more, although more than half of the patients who received the new device either died, suffered a stroke or had to have surgery to fix a failed device, the story quotes only patients who reported glowingly positive experiences.
The story also appears to have confused survival rates with the combined endpoint of survival without either a stroke or device failure. The story says that four times as many patients survived for two years with the new device; but the study reports that the two-year survival rates were 58 percent and 24 percent – more than doubling survival, not quadrupling it.
The story notes that the device costs $80,000 and that the implantation surgery costs about $45,000. It featured comments about how this new device will add to the substantial cost of advanced heart failure treatment. The story also pointed out that cost-effectiveness studies have not yet been done.
It would have been useful to see the costs of this newer device compared to those associated with existing devices.
The story reports the primary finding that after two years 46 percent of patients who received the new device were alive without having suffered a stroke or device failure, compared to 11 percent of the patients receiving the older device. It also pointed out that the study included 200 patients. However, it appears that the story misstates the results somewhat by saying the new device meant four times as many patients survived for at least two years. The 46 percent to 11 percent comparison includes patients who suffered a stroke or a device failure. The study reports that the two-year survival rates were 58 percent for patients with the new device compared to 24 percent for those who received the older device, more than doubling survival, but not quadrupling it. And rather than citing only relative risk reduction figures, absolute data should have been provided.
Considering that more than half of the patients either died, suffered a stroke or a device failure, the story paints an overly rosy view of patient outcomes by featuring only patients who report glowingly positive experiences.
The story notes that 14 percent of the patients receiving the new device died soon after the surgery. However, it did not mention the risk of strokes caused by bleeding, the risk of infection from the wires leading to the devices external power pack or other adverse events. And although patients in this trial who received the newer device required far fewer surgeries to replace or repair their pumps, the story should have noted that 12 patients who got the newer device (9 percent) needed to have surgery to replace a failed device.
The story reports the size and key features of the trial comparing new and old heart assist devices. However, it did not point out that patients and their doctors could likely tell which type of device was implanted and that this knowledge could have biased their evaluations of the effectiveness of the devices. Nevertheless, that potential bias would not have altered the primary outcomes of survival, stroke or device failure that the story highlighted.
Although this story does not exaggerate the seriousness of heart failure, it overstates how widely the new device is likely to be used based on the latest trial. The lead sentence says the new device could be a potential treatment for many people with severe heart failure, but in their New England Journal of Medicine article the authors wrote, “the trial was performed in a select patient population, and applicability to the broader population of patients with heart failure… would be speculative.”
The story includes independent experts. It also clearly points out that the trial was sponsored by the manufacturer of the device and that many of the researchers consult for the company or other device makers.
The story mentions that heart transplants are one option for patients with heart failure. However, it does not discuss drug management, which is the most common treatment for people with heart failure.
Because this story does not include details about the kind of patient who might be a candidate for this new device, readers may get the sense that drug treatment is relatively ineffective for typical heart failure patients and that this new device may offer many heart failure patients a better option, even though this latest trial included only patients with heart failure so advanced that standard therapies were losing their effectiveness.
The story notes that the new device is available and approved for patients who need temporary support while awaiting a heart transplant and that this study looked at how it compared to an older design that is also available to patients who are not candidates for heart transplants.
It would have been helpful to also point out that the surgery to implant the device is challenging and that there are a limited number of surgeons and centers with experience using this new device.
The story provides a brief outline of the history of heart assist devices and how they are progressively shifting from being temporary supports for patients awaiting transplant to long-term treatments for patients who may never be candidates for a transplant. It notes that the new feature of the device used in the trial is that it pushes blood continuously, rather than attempting to mimic the pumping pulses of a natural heart.
The story does not appear to rely on a news release.