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Watchman device use -Can we afford to overlook FDA’s warning about adverse effects?


Watchman device use -Can we afford to overlook FDA’s warning about adverse effects?

USA: An analysis of the US Food and Drug Administration (FDA) data throws light on the adverse events reported to the FDA from the use of the Watchman device (Boston Scientific). The device was approved in March 2015 for left atrial appendage (LAA) occlusion in high-risk patients with atrial fibrillation.

The reported adverse effects included pericardial effusion, device-related thrombus, cerebrovascular accident, and device embolization. Of nearly 3,000 adverse events reported to the agency’s Manufacturer and User Facility Device Experience (MAUDE) database, 42% involved pericardial effusion, 11% thrombus, 5.7% cerebrovascular accident, and 5% device embolization. There were also about 211 deaths.

The findings were reported by Swaiman Singh, Newark Beth Israel Medical Center, NJ, at TCT 2019.

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“Rather than discourage the use of the Watchman, the results provide information that operators can use to better manage these issues and improve patient outcomes,” Singh said at the conference.

But this is one view trying to trivialize such a mammoth number of adverse effects reported by users of Watchman device. Can we afford to subscribe to this view.

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LAA closure has emerged as an alternative approach, with the PROTECT-AF and PREVAIL trials of the Watchman device supporting its approval by the FDA in April 2015. However, the complication rates were high in the earliest studies.

In the PROTECT-AF trial, for instance, there was a 4.8% rate of pericardial effusion in the Watchman’s arm. Rates of side effects decreased in the subsequent PREVAIL trial, probably because operators were getting better with performing the procedure over time.

The investigators examined the FDA’s MAUDE database for adverse events related to the device reported between April 2015 and December 2018. They identified 2,974 events.

Key takeaways from the analysis:




Source: With inputs from TCT 2019

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