This non-interventional study aims to use artificial intelligence to improve theprediction of transcatheter heart valve interventions and optimize patient outcomes. Itis based on the analysis of retrospective data from various specialized centersworldwide.
The ENVISAGE study is a non-interventional, retrospective research study designed to
validate an artificial intelligence (AI)-based framework for the automated analysis of
cardiac imaging data, including multi-slice cardiac computed tomography (CT) and
transesophageal echocardiography (TEE). The primary objective is to predict the success
of transcatheter heart valve interventions, including aortic, mitral, and tricuspid valve
interventions (TAVI, TMVI, M-TEER, T-TEER). The AI framework developed in this study will
rely on deep learning algorithms, particularly convolutional neural networks (CNNs) and
other advanced models, to automatically segment critical anatomical structures and
perform accurate measurements of these structures from CT and TEE images. These
measurements will then be combined with pre-interventional clinical data to optimize
patient selection and intervention planning, as well as to predict surgical outcomes with
high accuracy. AI will also aim to reduce human error and inter-observer variability in
the interpretation of cardiac images, which could significantly improve clinical
outcomes.
Diagnostic Test: Medical imaging analysis via artificial intelligence algorithms
Development of AI algorithms based on pre-procedural imaging annotations and clinical
informations to predict the transcatheter procedural outcomes
Inclusion Criteria:
Patients who have reached the age of legal majority under local laws.
- For TAVI group: All patients who have had TAVI with a third generation transcatheter
heart valve (THV), with an available pre-procedural optimal quality CT scan as
defined by an ECG- gating CT with:
1. five to ten image volumes at cardiac phases from 5% to 95% R-R
2. 0.625 mm slice thickness
3. 0.625 mm spacing between slices
4. 0.88 mm in-plane pixel spacing
- For TMVI group: Patients who have had a TMVI with a dedicated device and screen
failures, with an available optimal quality CT scan.
- For TTVI group: Patients who have had a TTVI with a dedicated device and screen
failures, with an available optimal quality CT scan.
- For M-TEER: All patient who have had a M-TEER with 1) G4 or newer iteration of
MitraClip or 2) G2 or newer iteration of Pascal, with available pre-procedural TEE
videos images from one of two vendors: Phillips or GE, with clear identifiable views
of the Mitral valve, frame per second equal or higher than 40 frames per second,
acceptable 3D reconstructions.
- For T-TEER: All patient who have had a T-TEER with G4 or newer iteration of TriClip
or 2) G2 or newer iteration of Pascal, with available pre-procedural TEE videos
images from one of two vendors: Phillips or GE, with clear identifiable views of the
Tricuspid valve, frame per second equal or higher than 40 frames per second,
acceptable transgastric image with acceptable 3D reconstructions.
Exclusion Criteria:
- For TAVI group: Valve-in-valve procedures
- For TMVI group: Valve-in-valve and valve-in-ring procedures
- For TTVI: Valve-in-valve and valve-in-ring procedures
- For M-TEER: G3 or older MitraClip, G1 Pascal
- For T-TEER: G3 Triclip, G1 Pascal
Montefiore Medical Center New York
New York 5128581, New York 5128638, United States
Montreal Heart Institute, 5000 Rue Bélanger, Montréal
Montreal 6077243, Quebec 6115047, Canada
St Michael's Hospital Toronto
Toronto 6167865, Canada
St Paul's Hospital Vancouver
Vancouver 6173331, Canada
Centre Hospitalier Universitaire (CHU) de Bordeaux, 12 rue Dubernat 33404 Talence cedex
Bourdeaux 3031069, France
CHU Lille
Lille 2998324, France
CHU Marseille
Marseille 2995469, France
Centre Cardiologique du Nord Paris
Paris 2988507, France
Institut Cardiovasculaire Paris-Sud Paris
Paris 2988507, France
Centre Hospitalier Universitaire Rennes
Rennes 2983990, France
Clinque Pasteur Toulouse - France
Toulouse 2972315, France
University Medical Center Hamburg-Eppendorf
Hamburg 2911298, Germany
Heart Valve Center Mainz
Mainz 2874225, Germany
Istituto Clinico Città di Brescia
Brescia 3181554, Italy
San Raffaele Heart Valve Center Milan
Milan 3173435, Italy
Thomas Modine, MD, PhD
+33(0)5 25 377541
thomasmodine@gmail.com
Walid Ben Ali, MD, PhD
+1 5145611037
dr.walidbenali@gmail.com