An Artificial Heart Its Makers Say Could Be a Standard Replacement
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An Artificial Heart Its Makers Say Could Be a Standard Replacement
Our Review Summary
As we noted in our blog post about this story, we’ve been down this path before with journalistic enthusiasm for early announcements about an artificial heart device. We acknowledge that this was a "Global Business" story, not something that appeared in the Times’ health or science section. But what difference does that make? We found it on the web just as any surfer might. And should the standards for business reporting on medical devices be any different than they are for health/medical/science reporting?
Why This Matters
So much can go wrong in the 18 months or so before human testing begins. And so much can go wrong even once that human testing begins. Only one line addressed whether "the enterprise will succeed." But there was no questioning of the company’s claims "that it has the technology to make the implantation of it a standard surgical procedure." Will the New York Times report as fervently about pitfalls along the way if they occur as they did about this preclinical and arguably premature news coverage?
Criteria
Satisfactory
The story explains that the company "estimates its device will cost $176,000 to $226,000. When all expenses are considered, including hospital and surgical expenses, it says it will cost just over $315,000, about the same as a transplant."
Not Satisfactory
No data, no evidence of any kind provided.
Not Satisfactory
No discussion of potential harms – something that must be discussed with any artificial heart device.
Not Satisfactory
There was no evaluation of the evidence on this device so far. And with company projections that human testing is more than a year from beginning, the thin evidence base should have been part of the story.
Not Satisfactory
The story concludes:
- "Citing World Health Organization data that shows heart disease is the world’s leading cause of death, Mr. Conviti, the Carmat chief executive, estimated the potential market at “a minimum” of 100,000 patients a year in the United States and Europe. However, he said cost constraints meant it was unlikely that more than one-tenth of those patients would actually receive an artificial heart."
The broad "heart disease as leading cause of death" is not directly applicable to the target population for an artificial heart. One woman’s single vessel coronary artery disease – which qualifies as heart disease – is not another person’s end-stage heart failure. So even with the qualifying followup comments from the company exec, the story let him get away with a disease-mongering premise to start with.
Not Satisfactory
Besides quotes from the company executive, there was only one quote from an independent expert. But since he was not commenting on any evidence or track record for the French heart – or even any comment on its concept or design – we rule this unsatisfactory. No independent expert was quoted on the real "heart of the story."
Satisfactory
Barely satisfactory. No real comparison was made, but at least other devices that are approved or in development were noted.
Satisfactory
It’s clear from the story that human testing is far off: "The company hopes to start human testing in France by the end of next year."
Not Satisfactory
Insufficient explanation of what sets this device apart from others. Only this: "instead of picking up from older models of artificial hearts built on animal research, the developers of the new device had sought to use the tools of the digital revolution, namely computer-assisted design, hemodynamic modeling, regulation algorithms and simulations." But what does that mean about its novelty? No explanation or details given.
Satisfactory
Because of the background given about other devices approved or in development, and because of the quote from one surgeon who uses a competing device, we think it’s unlikely that the story relied soley on a news release.
Total Score: 4 of 10 Satisfactory
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