FEops’ AI-enabled Solution Changes TAVI Pre-procedural Decision in One Third of Patients

Data from the PRECISE-TAVI study, presented at the PCR Valves 2022 convention in London shows that Transcatheter Aortic Valve Implantation (TAVI) procedures planned by means of FEops HEARTguide result in an important change of pre-procedural decision making of the heart team, associated with favorable clinical outcomes.

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“FEops HEARTguide informs physicians with accuracy which patients are at risk for new pacemakers or paravalvular leaks. Procedure simulations complement contemporary precision medicine”

This prospective multicenter observational study, led by Prof Nicolas Van Mieghem (Erasmus Medical Center, The Netherlands), included patients with complex aortic anatomy defined as bicuspid aortic valve, small annulus or severely calcified aortic valve, treated with the Medtronic Evolut pro (+) device. This trial aimed to assess whether the use of FEops HEARTguide computer simulations based on cardiac CT-imaging can contribute to a change of the heart team’s TAVI planning decision compared to their traditional CT planning decision and if this is associated with favorable clinical outcomes.

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The trial results revealed a 35% change of pre-procedural 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 to what has been reported in scientific publications on patients with complex anatomy.

Prof. Dr. Nicolas Van Mieghem, Principal Investigator of PRECISE-TAVI added following: “FEops HEARTguide informs physicians with accuracy which patients are at risk for new pacemakers or paravalvular leaks. Procedure simulations complement contemporary precision medicine”

Christian Vincent, Sr Director Therapy Development at FEops concluded: “Although TAVI is a well introduced and safe procedure, patients with complex aortic anatomies may pose specific challenges and are still today associated with higher paravalvular leakage and new pacemaker implantation. With the results of the PRECISE-TAVI, we are very proud to have a strong impact on the heart team decision, contributing to favorable clinical outcome, also for these type of patients”

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