Added Value of Patient-specific Computer Simulation in Transcatheter Aortic Valve Implantation (TAVI) (TAVIguide)

The Value of Patient-specific Computer Simulation in the Planning of TAVI With the Self-expanding Evolut R Valve

Transcatheter aortic valve implantation is increasingly used to treat patients with severe aortic stenosis who are at increased risk for surgical aortic valve replacement and is projected to be the preferred treatment modality. As patient selection and operator experience have improved, it is hypothesised that device-host interactions will play a more dominant role in outcome. This, in combination with the increasing number of valve types and sizes, confronts the physician with the dilemma to choose the valve that best fits the individual patient. This necessitates the availability of pre-procedural computer simulation that is based upon the integration of the patient-specific anatomy, the physical and (bio)mechanical properties of the valve and recipient anatomy derived from in-vitro experiments. Patient-specific computer simulation may improve outcome of TAVI by proposing the valve size that best fits the individual patient.

The aim of this study is to assess the added value of patient-specific computer simulation in valve size selection.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Other: Computer simulation

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Belgium
  • Edegem, Belgium, 2650
    • Universitair Ziekenhuis Antwerpen
• Denmark
  • København, Denmark, 2100
    • Rigshospitalet
• Germany
  • Cologne, Germany, 50937
    • University Hospital Cologne-Heart Center
• Italy
  • Milano, Italy, 20132
    • Ospedale di San Raffaele
• Netherlands
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3015 CE
      • Erasmus Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with native severe aortic valve stenosis accepted for TAVI with the self-expanding Evolut R Valve by the local heart team

Description

Inclusion Criteria:

• Native severe aortic valve stenosis
• Planned for TAVI with the Evolut R Valve

Exclusion Criteria:

• Bicuspid aortic valve
• Extensive subannular calcifications
• Non-transfemoral access
• Poor CT quality
• Lack of written informed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Computer simulation; Patients in whom a computer simulation model will be obtained based on pre procedural CT	Other: Computer simulation; In these patients, a computer simulation model will be obtained based on pre procedural CT
Prospective compare group; Patients in whom no computer simulation model will be obtained

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decision 1- Valve size decision based on pre TAVI MSCT	Valve size decision based on pre TAVI Multislice Computed Tomography (MSCT), which is performed in all patients referred for TAVI in accordance to clinical routine, during the heart team meeting	an average of 2 days before TAVI, before TAVI and computer simulation
Decision 2- Valve size decision after knowledge of the computer simulation results	Valve size decision after availability of the results of computer simulation	an average of 1 day before TAVI, before TAVI but after computer simulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decision 3- Change of initial valve size decision during TAVI	Change of valve size decision during TAVI due to computer simulation	an average of 5 minutes after TAVI, directly after TAVI
Decision 3- Change of initial depth of implantation strategy during TAVI	Change of depth of implantation strategy during TAVI due to computer simulation	an average of 5 minutes after TAVI, directly after TAVI
Depth of implantation target	Initial depth of implantation strategy	an average of 2 days before TAVI, before TAVI and computer simulation
Depth of implantation target 2	Depth of implantation strategy after availability of computer simulation	an average of 1 day before TAVI, before TAVI but after computer simulation
Aortic regurgitation	To compare the predicted (simulation) and observed degree of aortic regurgitation (echo post TAVI - Valve Academic Research Consortium (VARC-2) criteria for aortic regurgitation)	an average of 4 days after TAVI, at hospital discharge
Correlation between predicted contact pressure and observed new conduction abnormality	To compare the predicted maximum contact pressure, contact pressure index and conduction abnormalities with the observed occurrence of new conduction abnormalities after TAVI	an average of 4 days after TAVI, at hospital discharge
MACCE	To assess the incidence of Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)	an average of 4 days after TAVI, at hospital discharge
Incidence of the aforementioned outcome measures in a prospective group in whom no computer simulation will be perfomed	To compare the clinical based valve size decision and the angiographic and echocardiographic valve performance, depth of implantation, new conduction disorders and MACCE in a prospectively collected group of patients in whom no computer simulation will be performed	an average of 4 days after TAVI, at hospital discharge

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Cardialysis B.V.; Feops
• Investigators: Principal Investigator: Peter PT de Jaegere, MD, PhD, Erasmus Medical Center

Publications and helpful links

General Publications

• Schultz C, Rodriguez-Olivares R, Bosmans J, Lefevre T, De Santis G, Bruining N, Collas V, Dezutter T, Bosmans B, Rahhab Z, El Faquir N, Watanabe Y, Segers P, Verhegghe B, Chevalier B, van Mieghem N, De Beule M, Mortier P, de Jaegere P. Patient-specific image-based computer simulation for theprediction of valve morphology and calcium displacement after TAVI with the Medtronic CoreValve and the Edwards SAPIEN valve. EuroIntervention. 2016 Jan 22;11(9):1044-52. doi: 10.4244/EIJV11I9A212.
• de Jaegere P, De Santis G, Rodriguez-Olivares R, Bosmans J, Bruining N, Dezutter T, Rahhab Z, El Faquir N, Collas V, Bosmans B, Verhegghe B, Ren C, Geleinse M, Schultz C, van Mieghem N, De Beule M, Mortier P. Patient-Specific Computer Modeling to Predict Aortic Regurgitation After Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2016 Mar 14;9(5):508-12. doi: 10.1016/j.jcin.2016.01.003. No abstract available.
• El Faquir N, Ren B, Van Mieghem NM, Bosmans J, de Jaegere PP. Patient-specific computer modelling - its role in the planning of transcatheter aortic valve implantation. Neth Heart J. 2017 Feb;25(2):100-105. doi: 10.1007/s12471-016-0923-6.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2017
• Primary Completion (Actual): January 8, 2019
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: June 5, 2017
• First Submitted That Met QC Criteria: June 20, 2017
• First Posted (Actual): June 23, 2017

Study Record Updates

• Last Update Posted (Actual): February 6, 2019
• Last Update Submitted That Met QC Criteria: February 5, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: TAVI; Computer simulation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: TAVIguide

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No