Initial Results Presented for St. Jude Medical's Amplatzer Amulet LAA Closure Device

November 2, 2016—Initial results from the Amulet Observational Study were presented at TCT 2016, the 28th annual Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC. The study is the largest, prospective evaluation of a percutaneous transcatheter left atrial appendage (LAA) closure device (Amplatzer Amulet, St. Jude Medical, Inc.) for stroke prevention in patients with nonvalvular atrial fibrillation. The study demonstrated that the Amulet device has a high implantation success rate and low major adverse events.

As summarized in the TCT announcement, the study enrolled 1,073 patients between June 2015 and September 2016 at 64 clinical sites in Europe, the Middle East, Asia, Australia, and South America. There were 1,060 patients who had device implantation, giving a technical success rate of 98.8%.

Major adverse events within 7 days of implantation included ischemic stroke (0.3%, n = 3), pericardial effusion requiring intervention (0.5%, n = 5), embolization (0.1%, n = 1), and bleeding (0.9%, n = 10). There were three deaths (0.2%) that occurred within 7 days of attempted implantation, two of which were adjudicated as procedure or device related, and one as unrelated to the device.

At 1- to 3-month follow-up, the majority of patients were on antiplatelet therapy only and the core lab-analyzed results of transesophageal echocardiography showed a closure rate of 99%.

In the TCT press release, David Hildick-Smith, MD, commented, “These results indicate that the Amplatzer Amulet is safe and associated with low rates of periprocedural and early adverse events, as well as demonstrating high closure rates. In addition, antiplatelet therapy appears to be an effective treatment strategy postimplantation in the short-term. Additional long-term data is necessary to confirm these promising early findings.”