The findings support results of several trials and suggest that patients with a higher-risk #PFO are likely to benefit from a pfo closure device.
According to findings presented at the 67th American College of Cardiology’s Annual Scientific Session, patients who received a medical device to close a patent foramen ovale (PFO) after a stroke fared better after 2 years in comparison with those who received stroke-preventing medications alone.
PFO trial details:
The trial enrolled 120 patients at 2 South Korean centers. All patients recently experienced a cryptogenic stroke and were found to have a high-risk PFO — meaning that the PFO was 2 millimeters across or larger, or the PFO was accompanied by an outgrowth of tissue protruding into 1 of the heart chambers.
- Researchers halted enrollment for the trial early, based on results of several recent trials that it was unethical to continue assigning patients to receive the PFO closure device when it had clear benefits.
- Half of the patients were randomly assigned to receive a PFO closure device (Amplatzer PFO Occluder, St. Jude Medical Group), while the other half received medical therapy alone.
- Despite the small trial size, the trial helped clarify those patients that are likely to benefit most from the medical device based on physical characteristics of the PFO.
- Each patient received medication such as anticoagulants or antiplatelet drugs, and the specific type was determined by each physician — no direct oral anticoagulants were used in the study.
- High-risk PFO included PFO with atrial septal aneurysm or hypermobility or PFO size.
- Patient outcomes were followed for 2 years.
- The primary endpoint included a composite of stroke, major bleeding events and death from vascular causes. While no events occurred in the 60 patients receiving PFO closure, among those receiving medication alone, 6 had a stroke and 1 had a transient ischemic attack.
According to cardiologist and lead author of the trial, Jae Kwan Song, MD-Asan Medical Center
“Considering the high prevalence of PFO in the general population and cryptogenic stroke patients, the key to appropriate use of this medical device is determining how to select optimal candidates for the procedure,” Kwan said in a statement. “Our study showed that the potential benefit from closure can be determined on the basis of the size of the PFO and the movement of the heart wall around the PFO.”
The trial was supported by a research grant from the Cardiovascular Research Foundation (CVRF) in Seoul, South Korea and the study was simultaneously published online in the Journal of the American College of Cardiology at the time of presentation.