This is a story about some of the new medical devices either on the market or in development to help people with serious heart conditions live longer. The story included several personal vignettes of individuals whose lives have been markedly improved with the technology. The story did a good job providing an interesting description of technology, but it failed to included any quantitative information that readers could use for insight about the likelihood of benefit or of harm from the use of the devices.
It is not possible for readers to evaluate the value of a treatment in the absence of information about how well devices work, how often problems occur, and how much treatment costs. So, while we applaud the space and time provided to report on this topic, we think that some of the space and time should have been given over to an exploration of some of the issues we look for in our criteria.
There was no discussion of costs – a huge issue. We learn a portfolio manager’s projection of the size of the potential market, but not a word about costs to the individual or to society.
The three patients interviewed had clear improvement in their quality of life. The story provided no data to assess how representative their experience was.
The story mentioned that infections, bleeding and stroke are fairly common without explaining what "common" really means. Are these problems that occur in more than half of patients? 25% 10% or ?%.
The story also raised the issue of what to do when the implanted device is able to keep pumping even though the patient’s other organ systems have shut down. But it provided no insight about how often this issue was something families of patients have to deal with.
The story included human interest vignettes rather than evidence. The story said that one of the manufacturers cited 1-2 year survival data of 60-70%, but we weren’t told if this is published and, if so, where. That’s not a rigorous evaluation of the evidence.
There is no disease-mongering of end-stage cardiovascular disease. But there is in another area. The story raised the specter of ‘unnatural death’, a potential issue that can come up for patients who have the implanted device. It quoted a clinical ethicist saying, "It’s not hard to imagine a person who has had severe stroke that has impacted both sides of the brain, the kidneys are shutting down, he is on a respirator, but yet the LVAD just keeps churning along." But stories should do more than "imagine" – they should report on true track records. The story didn’t give readers an idea of how frequently this is an issue.
Several clinicians and patients were interviewed as part of this story.
The story did not compare outcomes of patients following different treatment approaches.
It was clear from this story that the HeartMate II is an available product though the story did not indicate whether implantation of the device was something that could be done at any hospital or only in specialty facilities.
The story was pretty clear that the LVAD and TETS technology had been around.
Given the depth of the story, it’s clear that it didn’t rely solely or largely on a news release.