TAVIguide is a software that uses patient-specific CT data and biomechanical modeling to simulate transcatheter aortic valve implantation (TAVI) procedures. It allows prediction of how different TAVI devices will fit and function within the patient's unique aortic root anatomy. Preclinical studies have shown TAVIguide's predictions of valve frame deformation, calcium displacement, paravalvular leakage, and conduction abnormalities correlate well with postoperative CT and clinical outcomes.

1. FEops, Ghent, Belgium matthieu.debeule@feops.com
TAVIguide :
Next generation TAVI planning
TAVIguide v1.4

2. “The uniqueness of TAVIguide is that it combines both dimensions and
mechanical properties of both the device and recipient tissue. TAVIguide
allows us to predict and to understand how a device, a frame, a valve will fit,
sit and work once implanted into the human structure of the heart.”
- Prof Dr Peter de Jaegere -

3. TAVIguide: Next generation TAVI planning
Patient specific computer
model of aortic root based
on routine pre-operative CT
Mechanical behaviour of
different tissue regions is
incorporated
3D computer model of
transcatheter aortic valve
Mechanical behaviour of
stent frame is taken into
account
Prediction of valve
morphology and function
post-TAVI using virtual
simulations of tissue /
device interaction
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Provide additional information for evaluating the interaction of the TAVI device with
the anatomical environment

4. TAVIguide
TM
Reconstruction and analysis of aortic root
region to assess TAVI procedural
parameters
Aortic Root Morphology
Annular Measurements
Optimal projection angles
Valve size(s)
Virtual simulation of TAVI procedure with
one or more sets of device sizes and
positions to predict prosthetic valve - aortic
root interaction
Frame Morphology
Calcium Displacement
Paravalvular Leakage (PVL)
Contact Pressure
TAVIguide: Next generation TAVI planning
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5. TAVIguide: Workflow
Step3: CustomerStep2: FEopsStep1: Customer
Case Submission
• Secure web portal
• Upload routine clinical CT
images
• Indicate TAVI device
• Confirm expected delivery
date: On average 2 work days
Perform Analysis
• Annular measurements
• 3D reconstruction of aortic
root
• Predict device/host
interaction
• Simulations for one or
multiple sizes in different
positions
View Analysis
• Informed by e-mail when
completed
• Online 360° interactive
viewer / custom pdf report
• Consult different treatment
scenarios
• Allows for personalized
device size selection and
positioning
• Ability to include personal
discussion
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6. TAVIguide: Step1 – Case Submission
Upload CT as zip file
 Intended patients
• Transfemoral TAVI according to IFU of TAV manufacturer
 Exclusion criteria *
• Foreign body in the aortic root
• Bicuspid aortic valve of type 0 or 2 (Sievers classification)
• Large sub-annular calcifications
 Selection of device type
• Corevalve® EvolutTM R (Medtronic) => CVER
• Corevalve® (Medtronic) => CV
• Lotus® (Boston Scientific) => LT
• EvolutTM PRO (Medtronic) ** => PROR
* Excluded (rejected) cases will not be charged.
** The 34mm CoreValve® EvolutTM R can be simulated when the EvolutTM PRO is selected.
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7. CoreValve® EvolutTM R
Size 23 mm 26 mm 29 mm 34 mm
Annulus
Diameter
18-20 mm 20-23 mm 23-26 mm 26-30 mm
Annulus
Perimeter*
56.5-62.8
mm
62.8-72.3
mm
72.3-81.7
mm
81.7-94.2
mm
TAVIguide: Step2 – Perform Analysis
Annular measurements to select device sizes that can be simulated
LotusTM
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* Based on the annular dimensions, FEops will model all device sizes that are indicated according to the sizing chart from the valve
manufacturer. An additional size will be selected in case a certain annular dimension is close to the range indicated by the
manufacturer (e.g. a 26mm Evolut R will be selected if the annulus diameter is 23.5mm). This is indicated as "selected outside IFU“.
CoreValve® EvolutTM PRO

8. TAVIguide: Step3 – View Analysis
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9. 16
20
24
28
32
16 20 24 28 32
ModelinflowDmax[mm]
CT inflow Dmax [mm]
-6
-4
-2
0
2
4
6
16 20 24 28 32
Difference(model-CT)[mm]
Mean (Model, CT) [mm]
Dmax at inflow
Mean difference: +0.6mm; SD=1.1mmr = 0.92
Schultz et al., EuroIntervention 2016
Data from EMC Rotterdam; UZA Antwerp and ICPS Massy
The predicted frame deformation from the model was compared to post-operative
CT scans (n=33). Values for the maximum diameter at the inflow portion of the
valve are given (inflow Dmax).
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TAVIguide: Preclinical Evidence
Frame Morphology

10. TAVIguide: Preclinical Evidence
Data from EMC Rotterdam; UZA Antwerp and ICPS MassySchultz et al., EuroIntervention 2016
Data from EMC Rotterdam; UZA Antwerp and ICPS Massy
The predicted calcium displacement of the native leaflets in the model was
compared to post-operative CT scans (n=33). Values for the distance between
calcium and both coronary ostias are given.
-12
-8
-4
0
4
8
12
0 4 8 12 16 20
Model prediction MSCT-post Calcium – coronary ostia distance (33 pts)
Mean difference +1.0mm; SD 2.0mm
Mean (Model, MSCT) [mm]
Difference(Model-MSCT)[mm]
Calcium displacement was quantified by
measuring the distance from the coronary
ostia to the closest calcium nodule
Difference(Model-MSCT)[mm]
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Calcium Displacement

11. TAVIguide: Preclinical Evidence
Schultz et al., EuroIntervention 2016
Data from EMC Rotterdam; UZA Antwerp and ICPS Massy
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Calcium Displacement

12. TAVIguide: Preclinical Evidence
Accuracy: 0.8Cut-off: 16 ml/s
(60 pts)
de Jaegere et al., JACC Interv, 2016
Data from EMC Rotterdam and UZA Antwerp
TAVIguide predicts the severity of post-implantation paravalvular leakage (PVL)
that will occur after implantation of the valve (n=60). ROC analysis revealed that 16
ml/s is the cut-off value that best differentiates patients with none-to-mild and
moderate-to-severe PVL.
0
10
20
30
40
0+1 2+3
PredictedPVL[ml/s]
Sellers score
p < 0.001
N=15N=45
16 ml/s
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Paravalvular leakage

13. TAVIguide: Preclinical Evidence
The contact pressure on the aortic root and LVOT, due to interactions with the
frame and the native calcified leaflets, can be visualized.
If the transition between the membranous and muscular septum can be identified on the CT
images, a patient-specific region of interest, relevant for the atrioventricular conduction
pathway is identified. The contact pressure within this region of interest is quantified by 2
parameters:
• Maximum contact pressure (in MPa)
• Contact pressure index (i.e. percentage of region of interest subjected to contact pressure)
Region of
interest
Region of
interest
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Contact Pressure
Rocatello et al., Circ CI, 2018

14. TAVIguide: Preclinical Evidence
Definition of the region of interest:
The inferior boundary of the membranous septum is identified and used as anatomical
landmark for the His bundle and the take-off of the left bundle branch. Starting from this
boundary, a region of interest in vicinity of the atrioventricular (AV) conduction pathway is
defined. 14
Contact Pressure
Rocatello et al., Circ CI, 2018

15. TAVIguide: Preclinical Evidence
Both maximum contact pressure and contact pressure index were identified as the
only independent predictors of Conduction Abnormalities (n=112). ROC analysis
revealed that 0.39 MPa and 14 % are the resp. cut-off values that best
differentiates patients with and without conduction disturbances.
Accuracy: 0.76
Max. contact pressure
Cut-off: 0.39 MPa
Accuracy: 0.77
Contact pressure index
Cut-off: 14 %
Rocatello et al., Circ CI, 2018
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Contact Pressure

16. Case submission
3D interactive viewer vs pdf report
LIVE DEMO
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17. Interested to see for yourself on your own patients
1. Go to FEops.com
2.
3. Try it and get up to 3 TAVIguide analyses free of charge
or just contact us at info@feops.com
TAVIguide for your patients
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18. Instructions for use
• https://taviguide.com > ‘Help’
 In PDF
 EN, DA, DE, ES, FR and IT
• Upon request
 On paper
 Delivered within 7 days
 Free of charge
Label
• https://taviguide.com > ‘About’
TAVIguide: Instructions For Use - Label
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19. TAVIguide: System Requirements
Software Requirements
Hardware Requirements
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20. TAVIguide: Image Requirements
* Average CT image acquisition protocol specifications of data used for the verification of the TAVIguideTM system
• Optimal results:
 Only region containing heart and ascending aorta in FOV
 Sufficient amount of contrast agent for optimal visibility of left
heart lumen
 No patient movement
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21. TAVIguide: Warnings
TAVIguide™ is not intended to be used for TAVI patient selection, but to obtain
additional information for evaluating device-anatomy interaction for those patients
where a specific TAVI might be indicated according to the TAV manufacturers'
instructions for use.
TAVIguide™ is not intended to be used for complete TAVI procedure planning, but to
obtain information on certain options for performing TAVI (based on the TAV
manufacturers‘ instructions for use) and to obtain additional information for
evaluating device-anatomy interaction for those procedural options.
TAVIguide™ uses medical images and applies modeling and simulation techniques to
predict the prosthetic valve - aortic root interaction due to TAVI. This technology
inevitably relies on approximations and assumptions regarding anatomy, medical
procedure and biomechanical interaction. As a result, model predictions may be
inaccurate in certain cases. The accuracy of the TAVIguide™ simulation technology
has been evaluated preclinically using data collected retrospectively from TAVI
procedures. For information on the preclinical evaluation data, please contact FEops.
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22. DEMO CASES

23. Annulus
Mean diam 23.7mm
Perimeter 75.6mm
Area 434mm2
LVOT
Mean diam 22.5mm
Perimeter 74.6mm
Area 404 mm2
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Demo case 1: Lotus sizing

24. 24
Demo case 1: Lotus sizing

25. 25
Demo case 1: Lotus sizing

26. 26
Demo case 1: Lotus sizing

27. Annulus
Mean diam 24.5mm
Perimeter 79.9mm
Area 458mm2
LVOT
Mean diam 24.6mm
Perimeter 80.7mm
Area 437 mm2
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Demo case 2: Lotus sizing

28. 28
Demo case 2: Lotus sizing

29. 29
Demo case 2: Lotus sizing

30. 30
Demo case 2: Lotus sizing

31. FEops, Ghent, Belgium matthieu.debeule@feops.com
‘Chance only favours the prepared mind’
- Louis Pasteur