Original Title: 12-month results of a novel large access closure device: insights from the FRONTIER II Study.
Presenter: Arne Schwindt
The FRONTIER II trial assessed the safety and efficacy of the vessel closure device VIVASURE in more than 50 patients using the femoral access for TAVI or aortic endoprosthesis.
Puncture site was assessed at discharge, 30 days, 90 days and one year post procedure. Primary safety end point was complications incidence directly related to the device.
In 58 patients (66 access closure) there were no significant device-related vascular complications. Technical success was 97% and one year follow up in 42 patients did not show major or minor device-related complications
Conclusion
The new vessel closure device VIVASURE offers a safe and reliable alternative to the percutaneous closure of a big orifice in the femoral artery.
