NOTE TO READERS: When this project lost substantial funding at the end of 2018, I lost the ability to continue publishing criteria-driven news story reviews and PR news release reviews - once the bread-and-butter of the site going back to 2006. The 3,200 archived reviews, while still educational, are getting old and difficult for me to technically maintain on the back end of the website. So I am announcing that I plan to remove these reviews from the site by April 1, 2021. The blog and the toolkit - two of the most popular features on the site - will remain. If you wish to peruse the reviews before they disappear, please do so by the end of March 2021. After that date you may still be able to access them via the Internet Archive Wayback Machine - https://archive.org/web/.
Read Original Story

Replacing Heart Device Found Risky

Rating

3 Star

Replacing Heart Device Found Risky

Our Review Summary

This article does a good job reporting the findings of several new studies of surgery to replace potentially defective heart defibrillators. Two of the studies looked at how often patients needed repeat surgeries to replace malfunctioning pacemakers or more-complex devices called implantable cardioverter-defibrillators (ICDs). Rates appear to be dropping, according to the article, but it’s not clear what this might mean for people who received their device in a higher-rate year.

The third study tracked how often complications happened in Canadian patients who had ICDs replaced after safety advisories were issued for the devices. However, while the article mentions controversy about ICDs, it doesn’t provide much context. For example, readers would probably want to know how many problems happened among people who opted to leave their original devices in place despite the safety warnings. It might not be clear whether the expert who cited a risk of problems ‘well under 1%’ was referring to the original device or the replacement one.

Readers might also want to know if the quoted experts had any ties to the device manufacturers or to FDA, which regulates their use.

There is no mention of the cost of the devices themselves, nor of treating complications related to their malfunction or replacement.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

There is no mention of the cost of the devices themselves, nor of treating complications related to their malfunction or replacement.

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

Satisfactory

The article includes actual numbers of people who had devices replaced and experienced complications as a result. As noted above, it would have been useful to know how many devices malfunctioned in patients who didn’t have replacements. The actual rates of malfunctioning devices that had to be removed and replaced are also noted.

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

Not Satisfactory

The article focuses on complications in people who had their defibrillators replaced after a safety advisory, and on rates of defibrillator and pacemaker malfunction. It specifically mentions infections and deaths after devices were replaced, but it’s not clear what other complications can occur, or how serious they are. It would have been helpful to know what happens to people who have these devices but choose not to replace them–how often do malfunctions occur in devices after safety advisories are issued, and what happens to those patients?

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

Not Satisfactory

The article does not comment on the strengths and limitations or the similarities and differences in how the data on device malfunctions were collected and studied. For example, one of the studies analyzed data reported to the US Food and Drug Administration by device manufacturers, while another reviewed several registries of patients treated in North America, the United Kingdom, and Denmark. The article only briefly mentions how the findings compared.

Does the story commit disease-mongering?

Satisfactory

None noted.

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

Not Satisfactory

We give an unsatisfactory score for this criterion because the article does not mention that Dr. Krahn has received research and consulting payments from companies that make pacemakers and defibrillators. Dr. Maisel, author of two of the studies and a quoted expert, is an FDA consultant and chair of the panel that advises FDA on heart and circulatory devices. The third cited expert, Dr Curtis, previously held that post.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

There is no mention of whether there are other effective ways to manage irregular heart rhythms, nor other options for people who choose not to replace a device that’s under safety advisory.

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

Satisfactory

It is clear from the article that the devices studied are FDA approved.

Does the story establish the true novelty of the approach?

Satisfactory

It is clear from the article that these devices have been in use for a number of years.

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

Satisfactory

The article does not appear to have relied on a press release. Several experts are quoted.

Total Score: 5 of 10 Satisfactory

Comments

Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.