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New heart valve replacement procedure hailed


4 Star

New heart valve replacement procedure hailed

Our Review Summary

But benefits and harms seen in the trial weren’t adequately quantified to our liking, making it difficult for readers to judge the true scope of each as seen in the study.

Instead, a lot of space was given to exuberant quotes about “game changer…one of biggest steps in cardiovascular medicine in our lifetime” and predictions that the new approach “will be performed on tens of thousands of patients each year.”  All may become true.

But for now, we’d like to see more hard numbers.


Why This Matters

As the story mentions, aortic stenosis is common among the elderly population and information about a potential additional treatment option for those at the greatest risk is important.  The real question will be whether the benefit-harm tradeoff for the “minimally invasive” approach is good enough to outweigh the downsides of surgery.


Does the story adequately discuss the costs of the intervention?


The story indicated that the device costs around $30,000; and that combined with the costs of surgery, it works out to around $50,200 per year for the two additional years of life that might be obtained.

While not essential, it might be reasonable to raise the question of how these costs will likely be covered – i.e. out of pocket, insurance, medicare, hospitals – or some combination.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The new trial didn’t produce any mortality benefit at 1 year, and had an increased rate of stroke and bleeding (but less major bleeding and arrythmias than with surgery). These effects were not quantified, however, so it is hard to judge their relative importance.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

No absolute risk information was provided about potential harms.  This may have been the biggest weakness in the story.

Does the story seem to grasp the quality of the evidence?


In the big picture, the story adequately explained that for those in the high-risk category, valve replacement by a “minimally-invasive” procedure “is at least as effective as surgery.”

Does the story commit disease-mongering?


No overt disease mongering, but the story could have been improved by reporting the number of people in the US who fall into the 10% high risk category.

Does the story use independent sources and identify conflicts of interest?


Experts who were identified as not being involved in the study reported on were quoted in the story.

Does the story compare the new approach with existing alternatives?


For those patients who are among the top 10% at risk, the story reported on the results from a study that compared a potential new, catheter based treatment with the existing alternative, which is surgery

Does the story establish the availability of the treatment/test/product/procedure?


About 2/3 of the way through the piece, it was mentioned that the device is approved for use in Europe but not in this country, and that an FDA advisory panel is expected to consider it later this summer.

Does the story establish the true novelty of the approach?


The novelty and importance of the new approach was made clear, largely through the quotes of experts.

Does the story appear to rely solely or largely on a news release?


The story does not appear to rely solely on a news release.

Total Score: 8 of 10 Satisfactory


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