The study, presented as a late-breaking feature at the Transcatheter Cardiovascular Therapeutics conference in San Francisco, assessed the safety and performance of left atrial appendage closure devices over a 13-month period. The devices under scrutiny were Boston Scientific’s Watchman line and Abbott’s Amplatzer Amulet, both intended to be minimally invasive solutions for sealing off a small pocket within the heart wall, particularly in patients with atrial fibrillation.
Atrial fibrillation can lead to blood pooling in the appendage, forming clots that pose the risk of migrating to the brain and causing strokes. This study, known as SWISS-APERO, separated participants based on their heart anatomies to receive one of the two implants. After 45 days, subsequent CT angiography showed that both devices exhibited comparable appendage seals. The scans also indicated similar rates of patency after 13 months, along with comparable leak profiles. Additionally, both the Amulet and the Watchman devices, including Watchman 2.5 and Watchman FLX, demonstrated similar rates of definite or possible device-related blood clots at 2.4% and 3.8%, or two versus three cases, respectively.
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From a clinical perspective, a composite measure, which combined rates of cardiovascular death, stroke, and embolism, revealed similar outcomes between the two groups at 9.5% and 10.2%. The numbers of cerebrovascular and bleeding events were also alike. The findings were published in the American Heart Association journal Circulation.
Abbott’s Amplatzer Amulet received FDA approval in August 2021, following its initial CE mark in Europe in 2013. Earlier this year, the FDA issued a Class I recall of the Amplatzer Amulet sheath used during implantation procedures due to a potential risk of introducing an air embolism. It’s important to note that the recall did not impact the occluder implant itself.
On the other hand, Boston Scientific’s Watchman implant was initially approved in 2015. The latest iteration, the FLX Pro, received FDA clearance in September of this year. This upgraded device features a novel polymer coating that supports the natural healing process post-closure procedure and offers larger size options. Notably, Boston Scientific had previously received Watchman approval in September 2022, expanding the range of blood-thinning drug regimens available after implantation. The study’s results offer critical insights into these innovative devices and their potential benefits in preventing stroke for individuals with atrial fibrillation.
