New Stroke-Prevention Device Now Available Through International Clinical Trial
In late February, MedStar Heart & Vascular Institute at MedStar Washington Hospital Center became the first facility in the northeastern United States to implant a new left atrial appendage (LAA) occluder under an investigational device exemption.
Designed to pick up where WATCHMAN™ leaves off, the AMPLATZER Amulet device could potentially expand the pool of people eligible for the former’s ground-breaking approach to LAA closures and stroke prevention. Currently, MHVI is the only institution in Washington, D.C., Maryland and Northern Virginia to offer the alternative device.
Like WATCHMAN, Amulet is only appropriate for certain patients with non-valvular atrial fibrillation who are at high risk for not only stroke but also bleeding from long-term anti-coagulant usage.
Where Amulet differs, however, is in its reduced device length, which allows it to accommodate more diverse anatomies than the longer WATCHMAN, and in its elimination of the 45-day post-procedure blood thinner requirement. The latter is particularly relevant, says cardiac electrophysiologist Manish Shah, MD, principal investigator of the Amulet trial at MHVI, and the designated physician proctor for WATCHMAN within our metropolitan area.
“Between 20 and 30 percent of all stroke patients have AFib, so anything we can do to reduce their risk is a huge step forward,” he says. “By removing anti-coagulation from the equation, Amulet offers us another alternative to help manage stroke risk among vulnerable patients while protecting them from dangerous gastrointestinal or intracranial bleeds.”
Eligible study participants are randomly assigned to receive either Amulet or WATCHMAN, currently the only FDA-approved LAA closure device in the U.S.
- Patients in the WATCHMAN control group adhere to the standard protocol: warfarin for 45-days post-procedure followed by clopidogrel (Plavix®) and then baby aspirin therapy.
- For the Amulet patients, warfarin is replaced by a 60-day regimen of aspirin and clopidogrel after implantation before tapering off to baby aspirin alone.
The Amulet trial is currently taking place at around 50 sites throughout the U.S., Australia and Europe, with the goal of studying 1,600 patients over seven years. If you have a patient you believe may benefit from, or be eligible for, the Amulet trial, please contact Manish H. Shah, MD, principal investigator, at 202-877-7685 or Manish.H.Shah@medstar.net.