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The predictive value of FEops’ simulation technology

The FEops simulation technology suite relies on proprietary computational modeling and simulation techniques to offer medical device manufacturers and physicians detailed preoperative insights into the interaction between transcatheter structural heart devices and the patient’s anatomy.

Expertise in multiple structural heart therapy areas

Over 800 structural heart cases in different therapy areas have been modeled by FEops’ simulation technology, with robust results. The detailed, accurate predictions that FEops’ simulation technology provides on the interaction between the structural heart device and the patient’s specific anatomy contributes to improved clinical outcomes in multiple therapy areas:

Experts in TAVI intervention support, with a focus on bicuspid patients

Within the FEops HEARTguide™ family, the TAVIguide™ workflow is our first CE-marked product.

By combining routine preoperative CT images with patient-specific CM&S, TAVIguide™ predicts the interaction between the TAVI device and the patient’s unique anatomy, including post-implantation deformation, the risk for aortic regurgitation and conduction abnormalities.

Considering the extension of TAVI indications to younger, lower-risk patients (of which many have bicuspid aortic valves), these insights are key. Among these patients, the chance of complications such as paravalvular regurgitation and new permanent pacemaker remains high. This illustrates the need to more effectively risk-stratify bicuspid and lower risk aortic valve patients. 

Using TAVIguide™ in bicuspid aortic valve cases gives physicians detailed preoperative information about the interaction between the replacement valve and the patient’s anatomy – helping them improve outcomes and minimize risk.

https://www.youtube.com/watch?v=PIloai2gYjA

FEops HEARTguide™ is able to predict device/host interaction in detail for bicuspid patients.

How to use FEops TAVIguide™ 

1. Upload
Clinician uploads a ZIP file containing the patient’s CT images via the TAVIguide™ secure web portal. FEops will process personal data received from the hospital in conformity with the applicable data protection and privacy legislation.

2. Analysis
Our team generates a 3D reconstruction of the patient’s anatomy and applies proprietary FEops computational modeling and simulation approaches to predict device/host interaction. Device type is simulated in one or multiple sizes and positions.

3. Results
Clinician uses our 360° interactive viewing interface to consult multiple generated scenarios and receives a tailored PDF report within two working days.

TMVR/MAC intervention support

Transcatheter mitral valve replacement (TMVR) is a potential therapeutic option for the treatment of severe mitral regurgitation. Early clinical experience supports the feasibility of TMVR, but also highlights low enrollment in TMVR studies due to physicians’ concerns about the risk of left ventricular outflow tract (LVOT) obstruction.

FEops responds to this unmet clinical need by developing the FEops simulation technology as a unique pre-op planning tool for TMVR. It offers accurate simulation-based information about the effects of replacement device positioning and deformation within each patient’s anatomy. This provides physicians with better insights on the proper sizing of the replacement device and helps them identify the right position to avoid left ventricular outflow tract (LVOT) obstruction. 

Karady et al. demonstrates the predictive clinical value of FEops’ simulation technology in different case studies. In the second case report, post-op computational modeling and simulation predicted a patient’s unsuitability for TMVR. The prosthetic valve did not conform with the mitral valve anulus, potentially leading to device instability and a high risk of significant paravalvular regurgitation. This finding agrees with the unfavorable clinical outcome experienced with TMVR.

TMVR

“Overall, our initial results suggest that computer simulation may have the potential to improve patient selection for transcatheter mitral valve replacement in the presence of significant MAC.” 

- Karady et al. (2018). Journal of Cardiovascular Computed Tomography.

LAAo intervention support 

Percutaneous left atrial appendage (LAA) occlusion is a treatment option to reduce the chance of strokes in high-risk atrial fibrillation (AF) patients who are contraindicated for anticoagulation (OAC) drugs or who have suffered a stroke despite anticoagulation therapy.

Because the anatomy of the LAA differs strongly between individuals, accurate imaging is an important tool used by the operator to define the size and position of the occluder. Despite the detailed imaging available today, preoperative insights into how the occluder device will interact with the patient’s LAA are limited. Choosing the device size and position that will optimally occlude the LAA and predicting its stability or dislocation remains challenging.

In a retrospective case study analysis, FEops’ simulation technology combines pre-operative imaging with advanced computational modeling to provide detailed insights into the interaction between a device and a patient’s unique LAA. 

In this patient case, modeling was performed using FEops’ simulation technology after the clinical procedure. The output agrees with the clinical outcome: an incomplete apposition of both the disc and the lobe were predicted by FEops’ simulation technology.

Additionally, with the same device size, complete sealing at the level of the disc could have been achieved by implanting it in a more proximal position. This data suggests that FEops’ simulation technology may have the potential to predict optimal sizing and positioning, contributing to a better clinical outcome.

Retrospective modeling with FEops’ simulation technology shows incomplete sealing, which corresponds with the clinical outcome.

LAAo

With the same device size (22mm), a complete sealing at the level of the disc could have been obtained by implanting in a more proximal position (top).

Note: TAVIguide™ is a CE-marked product indicated for TAVI within the FEops HEARTguide™ family. CE mark for FEops HEARTguide™ with indication in TAVI and LAAo is expected in the first half of 2019.