LAA Closure May Provide Solution for Stroke Prevention in Patients With Prior Intracerebral Hemorrhage
PARIS, France—While there is still no consensus on optimal stroke prevention practices in patients with A-fib and previous intracerebral hemorrhage, a new study demonstrates promise for left atrial appendage (LAA) occlusion in this high-risk population.
Many of these patients often do not receive anticoagulation because of concerns about recurrent serious bleeding, Jens Erik Nielsen-Kudsk, MD, DMSc (Aarhus University Hospital, Skejby, Denmark), said today in a hotline session at EuroPCR 2016.
To explore an alternative to anticoagulation, he and his colleagues used propensity score matching to compare 147 patients from the Nordic region who received either the Amplatzer Cardiac Plug or Amulet LAA closure devices (St. Jude Medical) between 2009 and 2015 with an equal number of Danish patients who were treated with standard care and survived at least 180 days between 2005 and 2014.
Over a median follow-up of 166 days, the rate of the primary composite outcome (all-cause mortality, acute ischemic stroke, or major bleeding) was lower after LAA closure (47.9 vs 278.9 events per 1,000 patient-years). The lower risk compared with standard care remained after multivariate adjustment.
“These study data suggest transcatheter [LAA occlusion] to be a beneficial stroke prevention strategy in patients with atrial fibrillation and prior intracerebral hemorrhage,” Nielsen-Kudsk said, adding that his team plans to confirm the results in the randomized STROKECLOSE trial that will begin enrolling patients later this year.
‘A Clinical Problem We Always Have’
In a press conference, Nielsen-Kudsk explained that they only used the Amplatzer devices because they are the ones most often used in the Nordic region. “But of course [the results] could also be relevant for the Watchman device,” he said, adding that because guidelines recommend 45 days of anticoagulation treatment after Watchman implantation, operators may be more keen to choose a device that does not require postprocedure anticoagulation.
In a press conference, Nicolo Piazza, MD, PhD (McGill University Health Center, Montreal, Canada), said that, in reality, although the Watchman regulations exist, real-world practice does not always follow them. “Many of these patients are nonetheless put on dual antiplatelet therapy or single agents for a period of 25 days, 3 months, 6 months—very heterogeneous,” he explained.
Nonetheless, with the Amplatzer devices, only platelet inhibitors are required, and generally 6 months of aspirin monotherapy is the preferred treatment in the Nordic region, Nielsen-Kudsk reported. But the preference for standard care as monotherapy or no therapy at all is unclear.
“Looking into those data, we could see that almost 40% did not receive any treatment,” Nielsen-Kudsk said. “In the past few years, there have been observations that you could resume oral anticoagulation after a while—for instance after 2 to 3 months. There is a tendency now that those patients will receive [novel oral anticoagulant] drugs later on after the [intracerebral hemorrhage].”
During his presentation, the panel praised the research team for their “impressive results” in such a high-risk population. “This is a clinical problem we always have,” Piazza said, looking forward to the randomized trial Nielsen-Kudsk announced. “In the absence of any evidence out there in these sort of patients, [STROKECLOSE] is very important because it will answer several questions for our everyday clinical practice.”
- Nielsen-Kudsk JE. LAA occlusion vs. standard care in patients with atrial fibrillation and intracerebral hemorrhage. Presented at: EuroPCR 2016. May 18, 2016. Paris, France.
- Nielsen-Kudsk reports serving as a consultant to St. Jude Medical.