Results from a new analysis assessing real-world outcomes with the Watchman FLX (Boston Scientific) left atrial appendage closure (LAAC) demonstrated a low rate of major adverse events at seven days following the procedure.
The SURPASS analysis, which included data from more than 16,000 patients with non-valvular atrial fibrillation (AF) within the National Cardiovascular Data Registry (NCDR) were presented during a late-breaking trial session at CRT 2022 (26 February – 1 March, Washington DC) by Samir Kapadia (Cleveland Clinic, Cleveland, USA).
The data demonstrated a 0.37% rate of major adverse events at seven days following Watchman FLX implant or the time of hospital discharge, whichever was later. This safety endpoint was defined as a composite of all-cause death, ischaemic 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 a Watchman FLX implant included a 0.51% rate of pericardial effusion requiring either surgical or percutaneous intervention, with only 0.03% of patients requiring cardiac surgery.
“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 peri-device leak through 45 days,” said Kapadia. “SURPASS represents the experience of more than 2,000 physicians using this therapy in routine clinical practice.”
In the analysis, the WATCHMAN FLX device was successfully implanted in 97.6% of patients, and data also demonstrated low rates of ischaemic stroke (0.28%) and device embolization (0.03%) in patients at 45 days.
The SURPASS study is ongoing and will continue to collect outcomes through at least two years post-implant 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 ischaemic 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,” said Ian Meredith, global chief medical officer, Boston Scientific. “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.”