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Replacing Recalled Heart Devices a Risk

Rating

5 Star

Replacing Recalled Heart Devices a Risk

Our Review Summary

This article does an excellent job of providing both the details and the broader context for new findings about the risk of replacing implantable cardioverter-defibrillators (ICDs) that are the subject of safety advisories or recalls.

By explaining what the devices do, what can go wrong if they malfunction, and what malfunctions might mean for patients, the article helps readers understand why it is helpful to know what can happen if a recalled device is replaced instead of left in the body. The article makes it clear that while some malfunctions are deadly, others are minor–and that patients and their doctors have to decide whether to leave a device in place or to replace it based in part on the patient’s situation and what failure might mean. The role of these new data on the risks of replacement is made clear in the article. Another helpful aspect is the statement that the findings of the Canadian study also apply to the U.S.

The article also acknowledges that a quoted expert has received funding from device makers. Potential confusion over the term ‘recall’ is also noted, although not clarified.

One big issue that is not dealt with well is that the initial decision threshold for putting these devices in place may change now, based on the higher failure rates and the higher rates of complications with replacement. This would be a good followup story.

This story accomplished a lot in less than 800 words.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

The article notes that surgery to replace devices that are the subject of safety advisories can cost thousands of dollars.

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

Satisfactory

The article includes the numbers of patients who had serious complications after replacement surgery, as well as how many had minor problems. Data are also included that would help readers assess how the risks of replacing a device compare with the device manufacturers’ estimates of how often something could go wrong if it was left in place.

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

Satisfactory

Article lists all harms noted in the study, both serious and less serious, and explains that the authors did not track what happened to patients who did not have devices replaced. The story did note that untreated abnormal rhythms can be ‘potentially deadly’. However, the article notes that manufacturers estimate the rate of failure for devices that are subject to safety advisories, and also lists both the minor and serious things that can go wrong with them. One big issue that is not dealt with well is that the initial decision threshold for putting these devices in place may change now, based on the higher failure rates and the higher rates of complications with replacement.

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

Satisfactory

Article notes that the quoted expert has financial ties to device manufacturers, and that he asserts that this research was done without funding from the industry.

Does the story compare the new approach with existing alternatives?

Satisfactory

It is clear from the article that leaving a ‘recalled’ device in place is an option. Other options for treating heart rhythm problems are not noted. However, there are often not good options.

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

Satisfactory

It is clear from the article that defibrillators are available.

Does the story establish the true novelty of the approach?

Satisfactory

It is clear from the article that defibrillators are not a novel treatment.

Total Score: 10 of 10 Satisfactory

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