Boston Scientific’s Watchman FLX Device Assessed in SURPASS Analysis of Real-World Outcomes

February 28, 2022—Boston Scientific Corporation announced the presentation of results from a new analysis assessing real-world outcomes with the company’s Watchman FLX left atrial appendage closure device. The SURPASS analysis included data from > 16,000 patients with nonvalvular atrial fibrillation within the National Cardiovascular Data Registry (NCDR) Left Atrial Appendage Occlusion (LAAO) registry.

The findings were presented during a late-breaking trial session at CRT 2022, the Cardiovascular Research Technologies annual meeting held February 26 to March 1 in Washington, DC.

According to the company, the data demonstrated a 0.37% rate of major adverse events at 7 days after implantation of a Watchman FLX device or the time of hospital discharge, whichever was later. This safety endpoint was defined as a composite of all-cause death, ischemic stroke, systemic embolism, or device/procedure-related events requiring open cardiac surgery or major endovascular intervention.

Additional outcomes measured at the 45-day follow-up after implantation included a 0.51% rate of pericardial effusion requiring either surgical or percutaneous intervention, with only 0.03% of patients requiring cardiac surgery.

Boston Scientific noted that in the analysis, the Watchman FLX device was successfully implanted in 97.6% of patients. Data also demonstrated a 0.28% rate of ischemic stroke and a 0.03% rate of device embolization in patients at 45 days.

The SURPASS study is ongoing and will continue to collect outcomes through at least 2 years postimplantation on all patients in the NCDR-LAAO registry treated with Watchman FLX between August 2020 and August 2022. The key effectiveness endpoint of occurrence of ischemic stroke or systemic embolism will be evaluated after 24 months, stated the company.

“This analysis includes the largest number of real-world Watchman FLX patients to date and provides evidence that this stroke reduction therapy is associated with a low incidence of adverse events and peridevice leak through 45 days,” commented Samir Kapadia, MD, in the Boston Scientific press release. He added, “SURPASS represents the experience of > 2,000 physicians using this therapy in routine clinical practice.” Dr. Kapadia is Chairman of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine of the Sydell and Arnold Miller Family Heart, Vascular, & Thoracic Institute at the Cleveland Clinic in Cleveland, Ohio.

Boston Scientific’s Global Chief Medical Officer, Ian Meredith, MBBS, PhD, stated in the press release, “The strong safety and efficacy profile of the Watchman FLX device demonstrated in the SURPASS analysis reinforces many of the safety and effectiveness results seen in the pivotal PINNACLE FLX trial while representing a high-risk, real-world patient population and wide variety of patient anatomies. We look forward to further analyses from this large, representative study of patients with nonvalvular atrial fibrillation treated by physicians with a broad range of implanting experience.”