Marlborough, Massachusetts–based Boston Scientific posted data from the Surpass real-world analysis at the Cardiovascular Research Technologies (CRT) 2022 meeting.
Surpass included data from more than 16,000 patients with non-valvular atrial fibrillation (AFib) within the National Cardiovascular Data Registry (NCDR) Left Atrial Appendage Occlusion (LAAO) Registry, according to a news release. The data demonstrated only a 0.37% rate of major adverse events at seven days following a Watchman FLX implant or the time of hospital discharge (whichever came later).
Other key outcomes recorded at a 45-day follow-up point following Watchman FLX implant included a 0.51% rate of pericardial effusion requiring either surgical or percutaneous intervention, with 0.03% of patients requiring cardiac surgery, the company said.
Boston Scientific said the key 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.
Watchman FLX was successfully implanted in 97.6% of patients, with low rates of ischemic stroke (0.28%) and device embolization (0.03%) at 45 days. The Surpass analysis remains ongoing and will collect outcomes through at least two years post-implant on all patients in the registry treated with Watchman FLX between August 2020 and August 2022. The key effectiveness endpoint of ischemic stroke or systemic embolism will be evaluated after 24 months.
“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,” Boston Scientific Global CMO Dr. Ian Meredith said in the release. “We look forward to further analyses from this large, representative study of patients with NVAF treated by physicians with a broad range of implanting experience.”