First US commercial procedures with the Watchman device

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Three US patients have now received the first implants of the Boston Scientific Watchman left atrial appendage closure device. Watchman offers a stroke risk reduction option for high-risk patients with non-valvular atrial fibrillation who are seeking an alternative to long-term warfarin therapy. The device received US Food and Drug Administration (FDA) approval on 13 March.

The first Watchman procedures in the US were performed by Shephal K Doshi, director of Cardiac Electrophysiology and Pacing at Saint John’s Health Center in Santa Monica, and Saibal Kar, director of the Cardiovascular Intervention Center Research at Cedars-Sinai Hospital in Los Angeles.

“With today’s successful implantations of the Watchman device, we are changing the way we deal with stroke risk in high-risk patients with non-valvular atrial fibrillation,” said Kar. “For indicated patients like those who received an implant, Watchman reduces the risk of stroke, without the need for long-term anticoagulation therapy and its subsequent bleeding risks.”

“As physicians, we are always looking for new therapies to satisfy unmet patient needs,” said Doshi. “There are many patients like the ones we treated this week with the Watchman device who are suitable for warfarin, but are not ideal candidates for chronic anticoagulant use. These patients now have a new, proven option to reduce their risk of atrial fibrilation-related stroke.”

Watchman is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are deemed by their physicians to be suitable for warfarin, and have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin.

The device was approved by the FDA based on a robust clinical program, which has now included more than 3,300 patients with 6,000 patient-years of follow-up to date. The clinical programme provides strong evidence that Watchman can be implanted safely and reduces the risk of stroke in eligible patients while enabling most patients to discontinue warfarin.

Additionally, a meta-analysis of all of the randomised trial data demonstrated that while ischaemic stroke reduction favoured warfarin, Watchman provided patients with a comparable protection against all-cause stroke and statistically superior reductions in haemorrhagic stroke, disabling stroke, and cardiovascular death compared to warfarin over long-term follow-up.

Watchman has been commercially available internationally since 2009. It is registered in 75 countries and more than 10,000 patients have been treated with the device.