Nav: Home

Results from the AMULET OBSERVATIONAL STUDY reported at TCT 2016

November 02, 2016

WASHINGTON - November 2, 2016 - Initial results from the largest, prospective evaluation of a percutaneous transcatheter left atrial appendage (LAA) closure device (Amplatzer Amulet) for stroke prevention in patients with non-valvular atrial fibrillation show that the device has a high implant success rate and low major adverse events.

Findings from the AMULET OBSERVATIONAL STUDY were reported today at the 28th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine.

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. 1,060 patients had device implantation, giving a technical success rate of 98.8%. Major adverse events (MAEs) within 7 days of implant 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 seven days of attempted implant, two of which were adjudicated as procedure or device related, and one as unrelated to the device. At 1-3 month follow-up, the majority of patients were on antiplatelet therapy only and the CoreLab analyzed results of transesophageal echocardiography (TEE) showed a closure rate of 99%.

"These results indicate that the Amplatzer Amulet is safe and associated with low rates of peri-procedural and early adverse events, as well as demonstrating high closure rates," said David Hildick-Smith, MD, from the Sussex Cardiac Centre, Brighton and Sussex University Hospitals in Brighton, United Kingdom. "In addition, antiplatelet therapy appears to be an effective treatment strategy post-implantation in the short-term. Additional long-term data is necessary to confirm these promising early findings."

The AMULET trial was funded by St. Jude Medical. Dr. Hildick-Smith reported grant/research support and consulting fees/honoraria from St Jude Medical, Boston Scientific, Medtronic, Gore, Abbott, Occlutech and Edwards.

The results of the AMULET OBSERVATIONAL STUDY will be presented on Wednesday, November 2 at 9:40 AM ET in the Main Arena (Ballroom, Level 3) in the Walter E. Washington Convention Center.
-end-
About CRF and TCT

The Cardiovascular Research Foundation (CRF) is a nonprofit research and educational organization dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 25 years, CRF has helped pioneer innovations in interventional cardiology and has educated doctors on the latest treatments for heart disease.

Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the world's premier educational meeting specializing in interventional cardiovascular medicine. Now in its 28th year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field.

For more information, visit http://www.crf.org and http://www.tctconference.com.

Cardiovascular Research Foundation

Related Stroke Prevention Articles:

Hispanic individuals benefit from skills-based stroke prevention intervention
A culturally tailored program used when discharging stroke patients from the hospital helped to lower blood pressure among Hispanic individuals one year later, finds a new study led by researchers at NYU College of Global Public Health.
Study provides 10-year risk estimates for dementia, which may help with prevention in high-risk individuals who potentially could benefit from early targeted prevention
A Danish study provides 10-year absolute risk estimates for dementia specific to age, sex and common variation in the APOE gene, which may help identify high-risk individuals who potentially could benefit from early targeted prevention.
Keeping cost from getting in the way of stroke prevention
Stroke survivors under age 65 are having less trouble paying for the crucial medications that can stave off a bigger health catastrophe, thanks to expanded Medicaid and other Affordable Care Act provisions.
Stroke prevention drug combo shows promise, study says
If you've had a minor stroke or a transient ischemic stroke (TIA), taking the clot-preventing drug clopidogrel along with aspirin may lower your risk of having a major stroke within the next 90 days, according to new research published in The New England Journal of Medicine.
Education and feedback improve use of stroke prevention drugs in AF (IMPACT-AF)
Education of healthcare providers and patients with atrial fibrillation has led to a 9 percent absolute increase in the use of anticoagulation therapies to reduce stroke, according to late-breaking results from the IMPACT-AF trial presented today in a Hot Line LBCT Session at ESC Congress1 and published in the Lancet.
More Stroke Prevention News and Stroke Prevention Current Events

Best Science Podcasts 2019

We have hand picked the best science podcasts for 2019. Sit back and enjoy new science podcasts updated daily from your favorite science news services and scientists.
Now Playing: TED Radio Hour

Erasing The Stigma
Many of us either cope with mental illness or know someone who does. But we still have a hard time talking about it. This hour, TED speakers explore ways to push past — and even erase — the stigma. Guests include musician and comedian Jordan Raskopoulos, neuroscientist and psychiatrist Thomas Insel, psychiatrist Dixon Chibanda, anxiety and depression researcher Olivia Remes, and entrepreneur Sangu Delle.
Now Playing: Science for the People

#537 Science Journalism, Hold the Hype
Everyone's seen a piece of science getting over-exaggerated in the media. Most people would be quick to blame journalists and big media for getting in wrong. In many cases, you'd be right. But there's other sources of hype in science journalism. and one of them can be found in the humble, and little-known press release. We're talking with Chris Chambers about doing science about science journalism, and where the hype creeps in. Related links: The association between exaggeration in health related science news and academic press releases: retrospective observational study Claims of causality in health news: a randomised trial This...