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FDA Approves PFO Occluder for Stroke Prevention

Long-Term Data Shows Superiority to Medical Management

Satler
“Results demonstrate a 50 percent reduction in the incidence of repeat ischemic stroke among this population when treated with the occluder versus medical management.” —Lowell Satler, MD

After years of patient follow-up data, a lingering doubt among cardiologists and neurologists has finally been put to rest: The AMPLATZER™ PFO Occluder is better than anticoagulation alone for patients with stroke who have a patent foramen ovale (PFO). In October 2016, the FDA approved the device after reviewing data from 1,000 patients participating in the longitudinal, nationwide RESPECT trial. MedStar Washington Hospital Center, under the direction of principal investigator Lowell Satler, MD, was a lead site for RESPECT, enrolling the first patient into the seminal study.

“This green-light marks a major shift in how we manage stroke patients with a proven PFO, particularly those younger than 60,” says Dr. Satler, an interventional cardiologist and medical director of the hospital’s Catheterization Lab. “Results demonstrate a 50 percent reduction in the incidence of repeat ischemic stroke among this population when treated with the occluder versus medical management."

“Previous studies didn’t show any advantage over medical management, historically the standard treatment,” Dr. Satler says. “It wasn’t until researchers followed patients long enough that the occluder’s importance and benefits finally shone through.”

Robert Laureno, MD, chief of Neurology at MedStar Washington Hospital Center, participated by evaluating potential study participants before and after PFO implants. He calls the occluder a “valuable and viable new approach.” “Previously, we only had two options for preventing subsequent strokes due to PFO,” he says. “Lifetime anti-coagulation or anti-platelet therapy, or major open surgery to close the hole. Now specialists have another alternative.”

Deciding who is an appropriate candidate for the PFO occluder is a complex task, best achieved by a cardiologist and neurologist working together. Patients with cryptogenic stroke must first undergo a series of tests to rule out other potential causes, including atrial fibrillation (see related story below) and carotid atherosclerosis. Once PFO has been pinpointed as the likely culprit, a patient is further evaluated to assure the opening is anatomically suitable for closure.

If you have a patient you think may benefit from this device, contact the MedStar Structural Heart and Valve Disease Center, at 202-877-5975.


AMPLATZER™ Amulet™

Shah
“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." —Manish Shah, MD

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 [email protected].