FEops’ HeartGuide Solution Studied in PRECISE-TAVI

December 12, 2022—Belgium-based FEops announced that transcatheter aortic valve implantation (TAVI) procedures planned by using the company’s HeartGuide were shown to result in important changes of preprocedural decision-making of the heart team, associated with favorable clinical outcomes.

The prospective multicenter PRECISE-TAVI observational study, led by principal investigator Professor Nicolas Van Mieghem, MD, of Erasmus Medical Center in Rotterdam, The Netherlands, included patients with complex aortic anatomy defined as bicuspid aortic valve, small annulus, or severely calcified aortic valve, treated with the Evolut Pro+ device (Medtronic).

The study aimed to assess whether the use of FEops HeartGuide computer simulations based on cardiac CT imaging can contribute to a change in the heart team’s TAVI planning decision compared to their traditional CT planning decision and if this is associated with favorable clinical outcomes.

The findings from the study were presented at the PCR London Valves 2022 course held November 27-29 in London, United Kingdom.

According to the company, the trial results revealed a 35% change of preprocedural decision from the heart team, associated with favorable clinical outcomes. New pacemaker implantation rate and paravalvular leak (more than trace) in PRECISE-TAVI are 13% and 28% respectively, which is lower than what has been reported in scientific publications on patients with complex anatomy.

Prof. Van Mieghem commented in the company’s press release, “FEops HeartGuide informs physicians with accuracy which patients are at risk for new pacemakers or paravalvular leaks. Procedure simulations complement contemporary precision medicine.”

FEops stated that the HeartGuide cloud-based procedure planning environment uses digital twin technology to provide insights preoperatively into the interaction between transcatheter structural heart devices and specific patient anatomy for clinicians and medical device manufacturers.

FEops HeartGuide is available in the United States for use in left atrial appendage occlusion (LAAO) with the Watchman and Watchman FLX (Boston Scientific) and the Amplatzer Amulet (Abbott). In the European Union, United Kingdom, Canada, and Australia, FEops HeartGuide is available for use in TAVI and LAAO, advised the company.