FEops HeartGuide for LAAC Procedures Studied in Published PREDICT-LAA Trial

February 24, 2023—FEops, a Belgium-based developer of the HeartGuide cloud-based procedure planning solution, announced the publication of the PREDICT-LAA study showing that left atrial appendage closure (LAAC) procedures planned by means of HeartGuide resulted in significant improvement of procedural efficiency and outcomes.

PREDICT-LAA is a prospective, multicenter randomized clinical trial. In the study, 200 patients were randomized 1:1 to standard planning versus cardiac CT-simulation–based planning of LAAC with the Amplatzer Amulet LAA occluder (Abbott).

Professor Ole De Backer, MD, et al published the findings, “Impact of Computational Modeling on Transcatheter Left Atrial Appendage Closure Efficiency and Outcomes,” in JACC: Cardiovascular Interventions.

In September 2022, the PREDICT-LAA results were presented during the Late-Breaking Innovation session at TCT 2022, the 34th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held in Boston, Massachusetts.

The PREDICT-LAA trial is led by Prof. De Backer as Principal Investigator with Philippe Garot, MD. Prof. De Backer is from Rigshospitalet in Copenhagen, Denmark. Dr. Garot is from Institut Cardiovasculaire Paris Sud in Paris, France.

“PREDICT-LAA is the first prospective trial showing that the accuracy of the selection of the LAAC device size and implant position is significantly better when using FEops HeartGuide as compared to standard CT sizing,” commented Prof. De Backer in the company’s press release.

According to company, the PREDICT-LAA trial demonstrated procedural efficiency with a 15% reduction of the total number of LAAC devices used, a 50% reduction of the number of device repositionings, a 25% reduction of the use of radiation and contrast medium, a 20% reduction of procedural time, and procedural success without major complications in 100% of cases in the FEops HeartGuide arm.

Procedural outcomes also significantly improved with 40% more complete LAA occlusion with no LAA patency, 60% less retraction of the Amplatzer Amulet disc into the LAA, and 80% reduced risk of device-related thrombus, noted FEops.