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Philadelphia Inquirer highlights FDA “loophole” allowing use of heart device without testing

Penn study questions Lariat device to prevent stroke in heart patients

Our Review Summary

lariatAtrial fibrillation (AF) is a common cause of rapid, irregular heartbeat that puts people at increased risk for stroke. Approving new devices or surgical techniques to help reduce risk for these patients is important, and so this story is important for helping raise the alarm about a device that might not be safe enough and might need further testing. This story does a good job with several layers of complexity — how the regulatory process may have a loophole, the freedom doctors have to use devices off-label, and the new study that concludes by recommending surgeons should hold off on using the new Lariat device until more studies are done. These strengths notwithstanding, the story could have done a better job of describing current practices to prevent strokes in patients with AF and how this device may or may not be an additional option. It is known that a variety of blood thinners can significantly decrease the risk of stroke in patients with AF. However, there are risks associated with these blood thinners, including bleeding (including life-threatening bleeds in the brain that can be as serious as the effect of the blood clot they are trying to prevent), that mean not all patients can use them.


Why This Matters

This story discusses the application of a device that closes off the atrial appendage, a part of the heart where blood can pool in patients with atrial fibrillation, causing clots to form. The device was initially developed for use during open heart surgery, but has been adapted for placement via a catheter inserted through the patient’s vein. Closure of the atrial appendage may be a novel way to prevent formation of blood clots that can lead to stroke. However, there is currently a lack of evidence showing that the successful placement of such a device lowers the risk of stroke compared with no treatment or other established treatments. The article correctly points out that FDA rules for use of medications are different than for devices and highlights the need to modify regulations that on the one hand permit incremental innovation, but also limit use when the indication or method of using the device is significantly changed.


Does the story adequately discuss the costs of the intervention?

Not Satisfactory

This is an unusual story, not directly about a therapy that patients choose or buy. But we still think the price of the device — at a minimum — should be included. The cost of the procedure is also relevant, but not reported on.

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


The story discusses research on the use of the Lariat device for closing off a portion of the heart to lessen risk of clots. It says the procedure was performed in 309 people, successfully in 90 percent of them. It does not give us context to understand whether that level of benefit is equal or less than most other alternatives. There is lengthy discussion of harms – which we will address below. Perhaps more important, the story states that there is no evidence that the procedures lessen the risk of future strokes. That reduction in risk would be the most important benefit, and the fact that the story calls attention to this lack of evidence for benefit earns it a Satisfactory rating.

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


The story has many levels of harm to cover, and it does so in Satisfactory fashion. First, it identifies that a recent study published in JAMA of 309 cases of the use of the Lariat device showed urgent follow-up required in seven patients – 2.3 percent of the cases, and one death. Second, the story explains how and why some physicians choose to use a device off-label, not for a purpose identified at the time of its limited approval by the FDA. One of the physicians calls this a “regulatory loophole” and the JAMA study recommends further research before other doctors use the Lariat device for this purpose.

Our wish list for this story would have included some yardstick or context to help us understand these harms. How often would patients getting some alternative to the Lariat be expected to have a bad outcome? And in any group of 309 sick old people with failing hearts, how many bad outcomes should you expect, no matter what device is used? Another missing piece is one of the timing of the harms. Presumably these reports refer to short-term complications, most commonly within 30 days of the procedure, that can most directly be attributable to the device and/or its placement. What isn’t mentioned and warrants comment is that these devices are meant to make permanent changes. And we really don’t know what the long-term issues are with such devices.

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


This is a tough one, but all things considered we’ll give the story the benefit of the doubt. In general, the article did a good job of talking about this device as it relates to the broader FDA approval process. And the story makes it clear that the JAMA research was itself about an overall lack of evidence of safety of the Lariat device. That being said, we’d have appreciated more discussion of the evidence (or lack thereof) showing the device works and is effective. Why are we putting in these devices when there are medications that do the same job? The article touches on this by saying that the patients could not tolerate other therapies. But how well do these other therapies work and how does the Lariat perform in comparison?

Does the story commit disease-mongering?


There was no disease mongering.

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


The story quoted sources beyond only the study authors. Some of the study authors disclosed relationships with medical device companies such as Boston Scientific (which makes the Watchman device mentioned in the story); however, a quick search did not reveal any conflicts of interest for Drs. Giri  and Koren, the two expert sources who are directly quoted by the story.

Does the story compare the new approach with existing alternatives?


The story mentions that anticoagulant medication is “the usual course of treatment for preventing clots.” We’ll rate the story Satisfactory on that basis, although a broader discussion of established therapies for atrial fibrillation would have been welcome. As mentioned above, it simply isn’t clear whether these devices are safer or more effective than treatments that have been shown to have favorable risk/benefit profiles in randomized studies.

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


There was ample explanation of the Lariat being available, even though the JAMA study authors recommend that it no longer be used for the purpose of atrial fibrillation surgery. The story also discusses recent FDA approval of the Watchman device.

Does the story establish the true novelty of the approach?


The story did a good job of establishing the novel use of the Lariat device by doctors.

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


The story was not based on a news release and showed evidence of independent reporting.

Total Score: 9 of 10 Satisfactory


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