Patient Specific Mitral Valve Modeling for Surgical Planning and Training

Mitral valve disease is a common pathologic problem occurring in approximately 2% of the general population but climbing to 10% in those over the age of 75 in Canada[1]. This project has three primary goals all of which will positively affect cardiac patient care.

1) Create patient specific MV models for complex repairs that will allow surgeons the opportunity to practice the repair. 2) Potentially predict the outcomes following minimally invasive repair techniques such as transcatheter treatments (e.g., MitraClip). 3) Provide a model to train individuals on mitral valve repair techniques.

Study Overview

• Status: Unknown
• Conditions: Mitral Regurgitation; Mitral Valve Prolapse; Mitral Valve Disease
• Intervention / Treatment: Procedure: Mitral Valve Model

Detailed Description

BACKGROUND Mitral valve disease is a common pathologic problem occurring in approximately 2% of the general population, but climbing to 10% in those over the age of 75 in Canada. Of this group, approximately 20% have a sufficiently severe form of the disease that may require surgical intervention to restore normal valve function and prevent early mortality [4]. Evidence indicates that the surgeon's individual volume of mitral valve repair cases performed is a determinant of not only successful mitral repair rates, but also freedom from reoperation, and patient survival. For patients previously deemed inoperable due to co-morbidities, new techniques to treat mitral valve disease are being developed. However, assessing the optimal approach and the point at which clinical benefit is exceeded by the poor value or futility of the procedure is one of the biggest clinical challenges for physicians.

In the past decade, 3D echocardiography has emerged as a standard of care in diagnostic and interventional imaging for cardiac surgery and cardiology. This, coupled with the emergence of inexpensive 3D printing technology has led researchers and clinicians to explore how improved imaging and additive manufacturing can be used to improve patient outcomes.

In this context, the investigators have completed a proof-of-concept workflow for creating dynamic, patient specific mitral valve models. In concert with a left ventricle simulator 8], these valve models can mimic patient valve pathologies both anatomically and dynamically, as shown in Doppler ultrasound. In a 10 patient retrospective study, the investigators have demonstrated the ability to accurately re-create patient pathology, perform realistic surgical repairs, and assess realistic valve function post repair. The study team's vision is to create a simulator that can be used to assess patient candidacy for percutaneous interventions, assess different repair options for both percutaneous and surgical interventions, and finally use the model as a simulator for competency-based MV interventions.

RATIONALE Based on our successful proof of concept, the goal is to translate this technology to clinical use by validating our valve models. There are two primary long term goals. First, to validate a system for using patient specific MV models to: 1- assess intervention options, and 2: plan repair strategies for improved patient outcomes. Second, by building a database of MV pathologies, create a competency based simulator/trainer to provide surgeons with increased experience in MV repair techniques.

OBJECTIVES

1. Validate the accuracy of patient specific MV pathologies and repairs in a prospective 65 patient study;
2. Optimize our work-flow for creating valve models, in terms of accuracy, manufacture time required, and expense;
3. Validate the accuracy of our patient models for both surgical cases and transcatheter MitraClip interventions;

• Study Type: Observational
• Enrollment (Anticipated): 65

Contacts and Locations

• Study Contact: Name: Daniel Bainbridge, MD FRCPC; Phone Number: 5192004235; Email: daniel.bainbridge@lhsc.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with mitral regurgitation scheduled to undergo mitral valve repair with either a open heart surgical technique or with a MitraClip

Description

Inclusion Criteria:

• Patients undergo mitral valve repair with either surgery of MitraClip techniques
• Over 18 years old

Exclusion Criteria:

• Unable to place TEE probe
• Refuse consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mitral Valve repair; Patients undergoing mitral valve repair	Procedure: Mitral Valve Model; Creation of a mitral valve patient specific model to see if it mimics the patients valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MR following patient/model repair	The degree and location of residual MR following mitral repair surgery	Creation and assessment of the model within 1 week before or after surgery/intervention on the patient.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2D measurements of the mitral valve: Anterolateral-Posteromedial Diameter	A 2D measurements taken from the echocardiography images of the mitral valve and model	Assessment of model within 1 week of surgical or interventional repair on the patient
2D measurements of the mitral valve:Annular Height	A 2D measurements taken from the echocardiography images of the mitral valve and model	Assessment of model within 1 week of surgical or interventional repair on the patient
2D measurements of the mitral valve: Annular 3D Circumference	A 2D measurements taken from the echocardiography images of the mitral valve and model	Assessment of model within 1 week of surgical or interventional repair on the patient
2D measurements of the mitral valve:Annular 2D Area	A 2D measurements taken from the echocardiography images of the mitral valve and model	Assessment of model within 1 week of surgical or interventional repair on the patient
2D measurements of the mitral valve: Annular Ellipticity	A 2D measurements taken from the echocardiography images of the mitral valve and model	Assessment of model within 1 week of surgical or interventional repair on the patient
2D measurements of the mitral valve: Anterior Leaflet 3D Area	A 2D measurements taken from the echocardiography images of the mitral valve and model	Assessment of model within 1 week of surgical or interventional repair on the patient
2D measurements of the mitral valve: Posterior Leaflet 3D Area	A 2D measurements taken from the echocardiography images of the mitral valve and model	Assessment of model within 1 week of surgical or interventional repair on the patient
2D measurements of the mitral valve: Leaflet 3D Area	A 2D measurements taken from the echocardiography images of the mitral valve and model	Assessment of model within 1 week of surgical or interventional repair on the patient
2D measurements of the mitral valve: Mitral Regurgitation Orifice Area	A 2D measurements taken from the echocardiography images of the mitral valve and model	Assessment of model within 1 week of surgical or interventional repair on the patient
2D measurements of the mitral valve: Tenting Volume	A 2D measurements taken from the echocardiography images of the mitral valve and model	Assessment of model within 1 week of surgical or interventional repair on the patient
2D measurements of the mitral valve: Nonplanar Angle	A 2D measurements taken from the echocardiography images of the mitral valve and model	Assessment of model within 1 week of surgical or interventional repair on the patient
2D measurements of the mitral valve: tenting Height.	A 2D measurements taken from the echocardiography images of the mitral valve and model	Assessment of model within 1 week of surgical or interventional repair on the patient
ICU LOS	length of stay in the ICU	Postoperative period until ICU discharge (expected mean of 1 days)]
Hospital LOS	Length of stay in hospital	Postoperative period until hospital discharge (expected mean of 5 days)
Delirium	Delirium in hospital	Postoperative period until hospital discharge (expected mean of 5 days)
Renal failure requiring dialysis	Dialysis	Postoperative period until hospital discharge (expected mean of 5 days)
Stroke,TIA	Diagnosis of stroke	Postoperative period until hospital discharge (expected mean of 5 days)
Death in Hospital	Death	Postoperative period until hospital discharge (expected mean of 5 days)
Reoperation for Bleeding	Return to the operating room for re-exploration of the surgical procedure due to excess blood loss in the ICU	Postoperative period until hospital discharge (expected mean of 5 days)

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute

Publications and helpful links

General Publications

• Ginty O, Moore J, Peters T, Bainbridge D. Modeling Patient-Specific Deformable Mitral Valves. J Cardiothorac Vasc Anesth. 2018 Jun;32(3):1368-1373. doi: 10.1053/j.jvca.2017.09.005. Epub 2017 Sep 7.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2018
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: June 12, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Actual): August 1, 2018
• Last Update Submitted That Met QC Criteria: July 31, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Mitral Valve
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Valve Diseases; Heart Valve Prolapse; Mitral Valve Insufficiency; Prolapse; Mitral Valve Prolapse
• Other Study ID Numbers: 111462

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