FEops HeartGuide for Planning LAAO Procedures Evaluated in the PREDICT-LAA Trial

September 17, 2022—FEops, a Belgium-based developer of the HeartGuide cloud-based procedure planning solution, announced that data from the PREDICT-LAA trial demonstrated that left atrial appendage occlusion (LAAO) procedures planned via HeartGuide resulted in significantly improved procedural efficiency and outcomes.

According to FEops, PREDICT-LAA is a prospective, multicenter, randomized controlled trial that enrolled 200 patients to assess whether the use of HeartGuide computer simulations based on cardiac CT imaging can contribute to better preprocedural planning and improved procedural outcomes of percutaneous LAAO procedures with the Amplatzer Amulet device (Abbott).

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

The findings 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 September 16-19 in Boston, Massachusetts.

According to the company, regarding procedural efficiency, the results demonstrated a doubling of successful single device deployment; a 25% reduction of the use of radiation and contrast medium; a 20% reduction of procedural time; and 100% procedural success without major complications in patients treated in the trial's HeartGuide arm.

Additionally, procedural outcomes significantly improved with 40% more complete LAA occlusion with no leak; 60% less retraction of the Amplatzer Amulet disc into the LAA; and 80% reduced risk of device-related thrombus.

Dr. De Backer commented in the FEops press release, "PREDICT-LAA is the first-ever clinical study proving that artificial intelligence-enabled computational modelling of device-anatomy interaction significantly improves procedural outcomes. We are proud that we have been able to show that the accuracy of device sizing and positioning for LAAO procedures is significantly better when using FEops HeartGuide as compared to standard CT sizing."

FEops stated that HeartGuide uses digital twin technology to provide clinicians and medical device manufacturers with preoperative insights into the interaction between transcatheter structural heart devices and specific patient anatomy.

HeartGuide is available in the United States for use in LAAO procedures with Boston Scientific's Watchman and Watchman FLX and Abbott's Amplatzer Amulet. In the European Union, United Kingdom, Canada, and Australia, HeartGuide is available for use in LAAO procedures and transcatheter aortic valve interventions, advised FEops.