February 08, 2017
AMPLATZER™ Amulet™ Left Atrial Appendage Occluder Offers New Therapy Option for Patients at an Increased Risk of Stroke Due to Atrial Fibrillation
AUSTIN, TEXAS—On December 13, 2016, the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center became the first facility in Texas to implant the new AMPLATZER™ Amulet™ Left Atrial Appendage Occluder to seal off the left atrial appendage (LAA)—a small appendage connected to the left atrium—in patients diagnosed with non-valvular Atrial Fibrillation (A Fib). The AMPLATZER™ Amulet™ Left Atrial Appendage Occluder is currently being evaluated in the AMPLATZER Amulet U.S. IDE (investigational device exemption) Clinical Trial.
Rodney Horton, M.D., a cardiac electrophysiologist at the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, implanted the AMPLATZER Amulet occluder to reduce the risk of stroke in a patient suffering from non-valvular A Fib.
“What makes this device unique is that it closes the LAA without requiring a very deep structure, allowing us to close LAAs that could otherwise not be closed,” Dr. Horton said. “It is also made from a material that allows for the use of Plavix and aspirin, rather than full-strength blood thinners.”
The AMPLATZER Amulet occluder works by blocking the LAA at its opening, which minimizes the opportunity for blood clots to form in the LAA and migrate into the bloodstream, potentially causing a stroke. The AMPLATZER Amulet occluder is built with a longer lobe and waist than the previous version, and it is designed to allow for easier and more stable placement, which could result in shorter procedure times for patients. It comes in eight sizes to accommodate varying anatomies to address a wider range of complex patient anatomies than other LAA occluders.
In some patients with A Fib, the LAA does not contract effectively, causing blood clots. The clots can then be released into the heart and enter the bloodstream, where they can travel to the brain and cause a stroke. Currently, patients with A Fib who are at risk of stroke are often prescribed blood-thinning medication, but this treatment approach comes with a lifetime of medical management and the risk of major bleeding. By closing the LAA with the AMPLATZER Amulet occluder, physicians can “seal off” the LAA and potentially reduce the risk of stroke.
The AMPLATZER Amulet IDE trial is a randomized trial, which will enroll patients at up to 100 sites in the United States—including TCAI—and an additional 50 sites internationally. Patients enrolled in the AMPATZER Amulet IDE trial will be randomly assigned to receive either the Amulet device or an FDA-approved LAA closure device in the control arm of the study. Data collected across all trial sites will be used to support FDA approval of the AMPLATZER Amulet occluder.
Texas Cardiac Arrhythmia Institute
Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center is one of the world’s preeminent centers dedicated to the latest treatment advances for correcting abnormal heart rhythms such as Atrial Fibrillation (A Fib). The center is led by Executive Medical Director Andrea Natale, M.D., a world-renowned expert in the field. Natale is at the forefront of advancing treatment for A Fib, leading numerous clinical trials and participating in the development of new technologies and procedures. TCAI is part of St. David’s HealthCare, one of the largest health systems in Texas, which was recognized with a Malcolm Baldrige National Quality Award in 2014.
St. David’s Medical Center
St. David’s Medical Center is part of St. David’s HealthCare, one of the largest health systems in Texas, which was recognized in 2014 with a Malcolm Baldrige National Quality Award. Founded in 1924, St. David’s Medical Center is a full-service medical center offering comprehensive medical care at three locations—St. David’s Medical Center, Heart Hospital of Austin and St. David’s Georgetown Hospital.
Located in central Austin, St. David’s Medical Center includes a 350-bed acute care hospital and a 64-bed rehabilitation hospital providing comprehensive inpatient and outpatient care. It is home to the internationally renowned Texas Cardiac Arrhythmia Institute and St. David’s Neuroscience & Spine Institute. The hospital provides a complete range of women’s services, including its acclaimed maternity unit, maternal-fetal medicine, a high-risk maternal and neonatal transport team, the region’s largest and most sophisticated Neonatal Intensive Care Unit and The Breast Center; complex surgical services; a comprehensive Bariatric Surgery Center; and a 24-hour emergency department.
St. David’s Medical Center was recently ranked among the top hospitals in the nation by earning a five-star rating by the Centers for Medicare and Medicaid’s (CMS) new Overall Hospital Quality Star Rating system, and it was named among the nation’s 100 Top Hospitals by Truven Health Analytics from 2010 to 2016. Truven also named St. David’s Medical Center to the list of 50 Top Cardiovascular Hospitals in 2013, 2015 and 2016. The hospital earned a national distinction for patient safety from The Leapfrog Group from 2012 to 2016, and it received the 2016 Distinguished Hospital Award for Clinical Excellence from Healthgrades for the fifth consecutive year, as well as Healthgrades’ 2016 America’s 100 Best Hospitals Award™ for the second consecutive year.