Periodic Reporting for period 2 - HEARTguide (Disruptive personalized pre-operative planning tool for transcatheter procedures)
Reporting period: 2020-12-01 to 2021-11-30
While transcatheter procedures for heart structural diseases present strong advantages over open-heart surgeries, their adoption can be further improved because the difficulties to predict the optimal size and positioning of the heart implant can cause significant complication rates.
FEops has developed FEops HEARTguide, a cloud-based pre-operative planning platform that enhances transcatheter procedures. FEops HEARTguide uses computational modelling to predict the interactions between the implant and the real patient anatomy. The provided information has a potential impact on the treatment efficiency, quality of care, and reduction of complications for patients worldwide.
During the project, we will (i) extend FEops HEARTguide to a scalable platform for complete pre-operative planning, (ii) generate data in clinical reality & disseminate results and (iii) validate the go-to-market strategy.
FEops has developed FEops HEARTguide, a cloud-based pre-operative planning platform that enhances transcatheter procedures. FEops HEARTguide uses computational modelling to predict the interactions between the implant and the real patient anatomy. The provided information has a potential impact on the treatment efficiency, quality of care, and reduction of complications for patients worldwide.
During the project, we will (i) extend FEops HEARTguide to a scalable platform for complete pre-operative planning, (ii) generate data in clinical reality & disseminate results and (iii) validate the go-to-market strategy.
WP1 Technical development & validation
FEops HEARTguide is recognized as a very promising platform for pre-operative planning and peri-operative guidance of transcatheter structural heart interventions. We have developed a predictive model for a new indication, Transcather Pulmonary Valve Replacement (TPVR), and for new devices for our existing Transcatheter Aortic Valve Implantation (TAVI), Left Atrial Appendage Occlusion (LAAO) and Transcather Mitral Valve Replacement (TMVR) workflows in addition to extending our predictive models over different ethnic groups.
To turn FEops HEARTguide into a total solution, the LAAo simulation workflow has been extended with a complete anatomical analysis.
And finally, to turn FEops HEARTguide into a scalable pre-operative planning tool, deep learning models for automatic segmentation of the left atrium have been successfully trained.
The results of this work package contribute to the societal goals as device manufacturers are exploiting our technology to design next generation implants, which helps reducing the amount of trials in animals and humans.
WP2 Industrialization
To turn FEops HEARTguide into a scalable pre-operative planning tool, we have embedded new features and predictive models in the FEops HEARTguide platform and have prepared it for mass production. For the existing FEops HEARTguide workflows, we have automated the different steps of the process to shorten turn-around times and have developed Artificial Intelligence models to automate image segmentation & anatomical landmark detection.
With regards to certification, market clearance or approval has been obtained for EU under MDR, US, Australia and Canada.
The results of this work package have been disseminated through press releases, social media and at scientific conferences and helped to attract new talent: FEops has attracted more than 10 people since the beginning of the EIC-supported HEARTguide project and established international and interdisciplinary collaborations.
WP3 Clinical validation
The new features and predictive models have been clinically validated in over 700 patients along several retro- and prospective clinical investigations, in which we have generated evidence on the (i) predictive power and (ii) clinical and economical added value of our pre-operative planning platform FEops HEARTguide.
The principal investigators in charge of our clinical investigations, led the communication to their peers via scientific publications and at international scientific cardiology conferences.
WP4 Market validation
Supported with the evidence from the clinical investigations, we eased market entrance for FEops HEARTguide and created momentum in the market with limited access releases for the physicians and hospitals. More than 2,200 cases have been simulated over several centers worldwide, generating very useful feedback on the FEops’ business model and providing recurring revenue streams.
Although almost all physical meetings (conventions, business meetings transatlantic, …) were cancelled due to Covid-19, we have been able to keep good visibility with our target audience
FEops HEARTguide is recognized as a very promising platform for pre-operative planning and peri-operative guidance of transcatheter structural heart interventions. We have developed a predictive model for a new indication, Transcather Pulmonary Valve Replacement (TPVR), and for new devices for our existing Transcatheter Aortic Valve Implantation (TAVI), Left Atrial Appendage Occlusion (LAAO) and Transcather Mitral Valve Replacement (TMVR) workflows in addition to extending our predictive models over different ethnic groups.
To turn FEops HEARTguide into a total solution, the LAAo simulation workflow has been extended with a complete anatomical analysis.
And finally, to turn FEops HEARTguide into a scalable pre-operative planning tool, deep learning models for automatic segmentation of the left atrium have been successfully trained.
The results of this work package contribute to the societal goals as device manufacturers are exploiting our technology to design next generation implants, which helps reducing the amount of trials in animals and humans.
WP2 Industrialization
To turn FEops HEARTguide into a scalable pre-operative planning tool, we have embedded new features and predictive models in the FEops HEARTguide platform and have prepared it for mass production. For the existing FEops HEARTguide workflows, we have automated the different steps of the process to shorten turn-around times and have developed Artificial Intelligence models to automate image segmentation & anatomical landmark detection.
With regards to certification, market clearance or approval has been obtained for EU under MDR, US, Australia and Canada.
The results of this work package have been disseminated through press releases, social media and at scientific conferences and helped to attract new talent: FEops has attracted more than 10 people since the beginning of the EIC-supported HEARTguide project and established international and interdisciplinary collaborations.
WP3 Clinical validation
The new features and predictive models have been clinically validated in over 700 patients along several retro- and prospective clinical investigations, in which we have generated evidence on the (i) predictive power and (ii) clinical and economical added value of our pre-operative planning platform FEops HEARTguide.
The principal investigators in charge of our clinical investigations, led the communication to their peers via scientific publications and at international scientific cardiology conferences.
WP4 Market validation
Supported with the evidence from the clinical investigations, we eased market entrance for FEops HEARTguide and created momentum in the market with limited access releases for the physicians and hospitals. More than 2,200 cases have been simulated over several centers worldwide, generating very useful feedback on the FEops’ business model and providing recurring revenue streams.
Although almost all physical meetings (conventions, business meetings transatlantic, …) were cancelled due to Covid-19, we have been able to keep good visibility with our target audience
Description of the state-of-the-art
Patient-specific 3D pre-operative planning tools have been used for several years for transcatheter structural heart interventions, trying to give insight on the most optimal device size and device position, but none of the currently available tools is capable of accurately predicting the interaction between highly deformable heart implants with the patient anatomy and the resulting deformation of both the implant and the anatomy.
Progress beyond the state-of-the-art
The improvement in the field of patient-specific pre-operative planning for transcatheter structural heart interventions is based on integrating predictive models and Artificial Intelligence algorithms.
By integrating predictive models based on Finite element analysis, a form of mathematical modelling, the interaction of the heart implant and the patient specific heart can be analyzed in detail. This allows to more accurately predict the deformation of the heart implant and the patient anatomy, which provides unique insights to more accurately assess the risk for complications and to select the optimal implant size and implant position.
The systematic use of FEops HEARTguide in European cardiovascular centres will further increase the number of transcatheter procedures, and will also make these procedure more efficient and effective. This will have an impact not only on European healthcare costs but also on the well-being of the patient. Patients undertaking open heart surgery require extra intubation of 72h, more cardiac imaging and radiology, extra laboratory tests, boarding and nursing and they have a higher risk of being readmitted at the hospital. By providing higher predictive accuracy, complication rates decrease, which will open the transcatheter procedures market to patients who today would go to open-heart surgeries. FEops HEARTguide will also dramatically increase patients’ comfort as they return to their daily lives already three-four days after a transcatheter procedure, with no need for weeks-long disabling recovery following an open-heart surgery.
Patient-specific 3D pre-operative planning tools have been used for several years for transcatheter structural heart interventions, trying to give insight on the most optimal device size and device position, but none of the currently available tools is capable of accurately predicting the interaction between highly deformable heart implants with the patient anatomy and the resulting deformation of both the implant and the anatomy.
Progress beyond the state-of-the-art
The improvement in the field of patient-specific pre-operative planning for transcatheter structural heart interventions is based on integrating predictive models and Artificial Intelligence algorithms.
By integrating predictive models based on Finite element analysis, a form of mathematical modelling, the interaction of the heart implant and the patient specific heart can be analyzed in detail. This allows to more accurately predict the deformation of the heart implant and the patient anatomy, which provides unique insights to more accurately assess the risk for complications and to select the optimal implant size and implant position.
The systematic use of FEops HEARTguide in European cardiovascular centres will further increase the number of transcatheter procedures, and will also make these procedure more efficient and effective. This will have an impact not only on European healthcare costs but also on the well-being of the patient. Patients undertaking open heart surgery require extra intubation of 72h, more cardiac imaging and radiology, extra laboratory tests, boarding and nursing and they have a higher risk of being readmitted at the hospital. By providing higher predictive accuracy, complication rates decrease, which will open the transcatheter procedures market to patients who today would go to open-heart surgeries. FEops HEARTguide will also dramatically increase patients’ comfort as they return to their daily lives already three-four days after a transcatheter procedure, with no need for weeks-long disabling recovery following an open-heart surgery.