At the American Heart Association’s annual scientific sessions in Chicago, both Boston Scientific and Abbott showcased studies supporting their devices designed to seal the left atrial appendage (LAA). This pocket within the heart can increase stroke risk for individuals with atrial fibrillation, an irregular heartbeat.
Boston Scientific presented three-year data on its WATCHMAN FLX device, which aims to offer a safer alternative to first-line oral anticoagulation medications while providing similar protection against strokes. Meanwhile, Abbott announced five-year outcomes from a head-to-head study comparing its Amplatzer Amulet device to an earlier version of the WATCHMAN device.
The randomized, controlled OPTION trial involved 1,600 patients at moderate to high risk of stroke. Half of the participants received the WATCHMAN FLX implant, with nearly 40% having it placed during a cardiac ablation procedure. The remaining 60% received the device three to six months after undergoing radiofrequency or cryoablation.
Current treatment guidelines suggest that patients with multiple stroke risk factors continue long-term blood thinner therapy after an ablation, which can lead to bleeding risks. The OPTION study found that patients with the WATCHMAN FLX experienced fewer major bleeding incidents over three years—8.5% compared to 18.1% in the medication group, which primarily used direct oral anticoagulants and included about 5% on warfarin.
The trial also reported similar rates of all-cause death, stroke, or systemic embolism between the two groups, with the WATCHMAN FLX showing a rate of 5.4%, considered non-inferior to the control group’s 5.8%. Dr. Oussama Wazni, principal investigator of the study and vice chairman of cardiovascular medicine at Cleveland Clinic, noted high procedural success rates and patient adherence to prescribed medications following implantation, contributing to low rates of ischemic and hemorrhagic strokes.
Brad Sutton, M.D., Boston Scientific’s chief medical officer for atrial fibrillation solutions, expressed optimism about expanding indications for the WATCHMAN FLX and positioning it as a frontline therapy for patients undergoing cardiac ablation.
Abbott’s Amulet IDE trial compared its Amplatzer Amulet device against the WATCHMAN 2.5, which received FDA approval in 2015. This study is noted as the largest of its kind, enrolling nearly 1,900 patients. After five years, Abbott reported that 94% of patients with the Amulet no longer required blood thinners, compared to 90.9% of those with the WATCHMAN 2.5.
Dr. Dhanunjaya Lakkireddy, principal investigator of Abbott’s study and executive medical director at Kansas City Heart Rhythm Institute, highlighted the importance of minimizing blood thinner use due to potential side effects like excessive bleeding and dizziness.
Published in the Journal of the American College of Cardiology, Abbott’s study showed similar clinical outcomes between both devices regarding cardiovascular death, stroke, and systemic embolism rates—20.3% for Amulet versus 20.7% for WATCHMAN—and annualized ischemic stroke rates at 1.6% per year for both.
Sandra Lesenfants, senior vice president of Abbott’s structural heart business, emphasized that the Amplatzer Amulet redefines LAA closure by utilizing dual-seal technology that effectively seals the LAA without necessitating blood-thinning medication post-procedure. She noted that these results reinforce the safety and effectiveness of the Amulet device while helping patients reduce their stroke risk and improve their quality of life.
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