Sam Brusco, Associate Editor03.01.22
Boston Scientific released real-world assessment results for its WATCHMAN FLX left atrial appendage closure (LAAC) device. SURPASS trial analysis presented at this year’s Cardiovascular Research Technologies (CRT) meeting used data from over 16,000 patients with non-valvular atrial fibrillation (AFib).
Results showed a 0.37 percent rate of major adverse events (all-cause death, ischemic stroke, systemic embolism or device/procedure-related events requiring open cardiac surgery or major endovascular intervention) at seven days using the WATCHMAN implant. 45-day follow-up outcomes showed 0.51 percent rate of pericardial effusion requiring intervention. Only 0.03 percent of patients required 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," Dr. Samir Kapadia, chairman of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute, Cleveland Clinic, told the press. "SURPASS represents the experience of more than 2,000 physicians using this therapy in routine clinical practice."
WATCHMAN FLX was successfully implanted in 97.6 percent of patients with 0.28 percent rates of ischemic stroke and 0.03 percent rates of device embolization at 45 days. The study will continue for at least two years to collect more outcomes.
"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 Dr. 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."
Results showed a 0.37 percent rate of major adverse events (all-cause death, ischemic stroke, systemic embolism or device/procedure-related events requiring open cardiac surgery or major endovascular intervention) at seven days using the WATCHMAN implant. 45-day follow-up outcomes showed 0.51 percent rate of pericardial effusion requiring intervention. Only 0.03 percent of patients required 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," Dr. Samir Kapadia, chairman of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute, Cleveland Clinic, told the press. "SURPASS represents the experience of more than 2,000 physicians using this therapy in routine clinical practice."
WATCHMAN FLX was successfully implanted in 97.6 percent of patients with 0.28 percent rates of ischemic stroke and 0.03 percent rates of device embolization at 45 days. The study will continue for at least two years to collect more outcomes.
"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 Dr. 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."