September 17, 2022
2 minutes to read
Source / Disclosures
Lakeredde D et al. Late Science in Structural Cardiology: Session Two, in Collaboration with European Heart Journal / Eurointervention. Presented at: TCT Scientific Symposium; 16-19 September 2022; Boston (mixed meeting).
Lakereddy reported receiving a consultant fee or speaker fee/fee from Abbott Vascular, BIOTRONIK, Janssen & Johnson & Johnson.
BOSTON – At 3 years, the Amplatzer Amulet has remained superior to left atrial appendage obstruction and inferior in safety and efficacy compared to the Watchman, researchers report at TCT 2022.
The Amulet IDE large-scale randomized trial compared two left atrial obstruction (LAAO) devices, Amulet (Abbott) and Watchman 2.5 (Boston Scientific), in patients with non-valvular atrial fibrillation requiring stroke prevention.
“The take-home message to the general public is to trust the closure of the amulet to provide immediate and long-term closure so that patients can safely remove oral anticoagulant medications from their daily lives,” Dhanunjaya Lakkireddy, MD, clinical electrophysiologist and medical director of the Kansas City Heart Rhythm Institute at HCA Midwest Health, during a press conference. “It enhances the initial results and our knowledge of these devices.”
According to a company press release issued when The device has been approved by the Food and Drug Administration In August 2021, Amulet features instant LAAO “double seal technology”, which reduces the risk of stroke and eliminates the need for oral anticoagulation. Watchman 2.5 uses a single sealing seal.
For the Amulet IDE trial, researchers randomly assigned 1,878 patients with non-valvular atrial fibrillation at risk for LAAO stroke using either Amulet or Watchman devices (mean age, 75 years; 60% men).
Like Healio Previously mentionedThe Amulet was superior to the LAAO and not inferior in safety and efficacy at 18 months compared to the Watchman 2.5.
For the current analysis, researchers evaluated the efficacy and safety of a 3-year amulet compared to a Watchman. Outcomes of interest included a composite of stroke, systemic embolism, or CV death. death from all causes and death from autobiography; Significant and complex bleeding from stroke or systemic embolism.
More patients in the Amulet group completed a 3-year follow-up than the Watchman group (92% versus 86.7%) due to more deaths and withdrawals in the Watchman group by 18 months, Lakeriddy said at the press conference.
At 3 years, more patients in the Watchman arm were taking oral anticoagulants for thrombosis associated with the device than in the mascot group (3.7% vs 7.3%; s <.01) according to the study.
The researchers reported a trend toward lower CV and all-cause mortality among participants assigned to the amulet compared to Watchman 2.5.
The rates of systemic stroke/embolism (mascot, 5%; observer, 4.6%) and major bleeding (mascot, 16.1%; observer 14.7%) were similar between the two groups (s > .05 for both).
Furthermore, device-related factors such as thrombosis or leakage around the device more often preceded stroke after LAAO with Watchman than with Amulet (17 patients vs 4 patients) after 6 months.
“The results were comparable for 3 years,” Lakereddy said during the presentation. “There was a slight trend toward a higher rate of CV death and all-cause death in the Watchman arm…ischemic stroke/combined systemic embolism; major bleeding outcomes were not significantly different between these two groups.”
Lakeriddy noted during the press conference that since the Amulet IDE study, a new generation of the Watchman-FLX has entered the market.