Device-related factors and all-cause death represented categories favoring Amplatzer Amulet against Watchman, according to a news release.
Abbott designed its Amplatzer Amulet left atrial appendage (LAA) occluder with dual-seal technology. It features a lobe or piece to fill the cavity of the LAA and a disc to close off the opening into the LAA. The company said it is the first and only minimally invasive treatment option to offer immediate and complete dual-sealing closure of the LAA. It reduces the risk of stroke and eliminates the need for blood-thinning medication.
The prospective, international, multi-center Amulet IDE trial is the largest randomized LAA occlusion study to date, Abbott said. It included more than 1,800 patients.
Abbott reported three-year outcomes demonstrating that device-related thrombosis or peri-device leak more frequently preceded strokes in patients with Watchman compared to those with Amulet. Additionally, the company said that cardiovascular and all-cause death trended higher in the Watchman device than the Amulet device.
Data from last year’s TCT demonstrated that Boston Scientific’s next-generation Watchman FLX stroke prevention device outperformed the Amulet device. Findings from the SEAL FLX single-center, retrospective study of 300 Danish patients found that Watchman FLX demonstrated superiority in the area of LAA closure and peri-device leak.
More Amulet data
Abbott also presented data from its PREDICT-LAA trial. The prospective, multi-center, randomized controlled trial evaluated the planning process of Amplatzer amulet procedures.
The study looked at the use of cardiac computed tomography-based computational models — high-resolution heart scans generated by FEops HEARTguide. It evaluated if those scans help in the planning of Amplatzer Amulet procedures.
Results demonstrated improved procedural efficiency and safety outcomes associated with HEARTguide planning.
Abbott TriClip performs well
Abbott presented the first results from the TRILUMINATE pivotal trial at TCT 2022. It is the company’s first randomized, controlled trial evaluating the safety and effectiveness of TEER with TriClip. The study evaluated 700 patients with severe tricuspid regurgitation (TR). Patients spanned the U.S., Canada and Europe.
Results from the roll-in cohort through 30 days demonstrated high implant success rate of 99%. The study also observed at least a one-grade TR reduction in 91% of patients. Additionally, 74% of patients achieved moderate or less residual TR.
Patients achieved around a 17-point improvement on the KCCQ score. The 30% improvement from baseline demonstrates a “substantial improvement” in quality of life.
More to come
Abbott is presenting data from its CONFIDENCE Registry on Sunday. The international, prospective, real-world study evaluates the safety and effectiveness of Portico TAVI (transcatheter aortic valve implantation).
The study used the first-generation Portico delivery system in 501 patients and the second-generation FlexNav system in 500 patients.