Study suggests major clinical benefit for left atrial appendage occlusion


St Jude Medical has announced results from two cardiovascular clinical trials presented at EuroPCR 2016. The studies, which look at how St Jude Medical’s fractional flow reserve (FFR) technology impacts patient outcomes in acute coronary syndrome and a comparison of left atrial appendage occlusion (LAAO) therapy to standard medical treatment, were presented during hotline sessions.

The PRIME-FFR study aimed to quantify the value of FFR when deciding the most appropriate treatment for patients with acute coronary syndrome.

In assessing the value of FFR, the study’s investigators defined management strategies for patients based on angiography results before performing FFR, and then made a final treatment strategy decision after performing FFR. Results showed that management strategy reclassification after performing routine FFR was high and that FFR is safe to use in ACS patients, indicating a management strategy guided by FFR safely leads to changes in physician decision making.

Researchers also assessed the impact of a LAAO in patients with atrial fibrillation and intracerebral hemorrhage versus patients who received standard medical therapy.

The LAAO in atrial fibrillation and intracerebral hemorrhage study found that patients with AF and a prior intracerebral hemorrhage who were treated with a St Jude Medical LAAO device had a lower risk of ischaemic stroke, major bleeding and all-cause mortality compared to patients treated with standard care, suggesting that LAAO offers a major clinical benefit.

“Patients with atrial fibrillation and previous intracerebral hemorrhage have an increased risk of ischemic stroke or repeated hemorrhage,” says Jens Erik Nielsen-Kudsk, an associate professor of cardiologic medicine at Aarhus University (Aarhus, Denmark) and the study’s lead author. “The data from the this latest clinical assessment further shows that having a device like the AMPLATZER LAA occlusion device implanted in these patients’ hearts offers them additional opportunity for improved cardiac health.”