Clinical Impact of Rapid Prototyping 3D Models for Surgical Management

Study Overview
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Brief Summary
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Patient-specific, 3D printed models have been utilized in preoperative planning for many years. Among researchers and clinicians, there is a perception that preoperative exposure to 3D printed models, derived from patient images (CT or MRI), aid in procedural planning. 3D printed models for heart surgery have the potential to improve a clinician's preparedness and therefore may reduce surgically-related morbidity and mortality. This randomized clinical trial aims to evaluate whether pre-procedural planning of surgeons exposed to a patient-specific 3D printed heart model will decrease cardiopulmonary bypass time, morbidity, and mortality.

Detailed Description
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3D imaging and rapid prototyping 3D printing technology have advanced to the point where it is feasible to marry the two to produce a patient-matched and accurate 3D model of congenital heart defects. The production of a 3D model of the heart may be particularly useful in anticipation of surgery such that the operator can plan and visualize the surgery prior to the surgical date with a physical heart he or she can manipulate in their hands. Preliminary studies demonstrate potential for clinical impact of 3D models on patient care and patient outcomes. 3D models have long been shown to enhance education and communication of anatomy. In 2008 Kim et al reviewed 3D printed models as an emerging technology in management of congenital heart disease, and also suggests that physical models may also help enhance patients and physicians' understanding of congenital heart disease. Our group has also published on the clinical and educational value of these 3D heart models. To date, no systematic trial identifying the value of 3D models on procedural planning has been published.

Official Title
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Clinical Impact of Rapid Prototyping 3D Models of Congenital Heart Disease on Surgical Management

Conditions
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Double Outlet Right Ventricle, Transposition of the Great Arteries, Truncus Arteriosus, Congenitally Corrected Transposition of the Great Arteries

Intervention / Treatment
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* Diagnostic Test: 3D Printed Heart Model


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric subjects undergoing primary complex two-ventricle repair of congenital heart defect, including but not limited to: double outlet right ventricle (DORV), transposition of the great arteries with ventricular septal defect and pulmonary stenosis (TGA/VSD/PS), truncus arteriosus with ventricular septal defect (TA/VSD) congenitally corrected transposition of the arteries with pulmonary stenosis (CCTGA/PS). Patient who will undergo preoperative cardiac MR or cardiac CT imaging a. Images will be validated by the IRC prior to inclusion Written informed consent (and assent when applicable) and HIPAA authorization obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study. Exclusion Criteria: Complex defects involving atrioventricular valve anomalies complete or transitional atrioventricular canal double inlet left ventricle tricuspid atresia mitral atresia Defects with valve dysfunction requiring an extensive valvuloplasty Patients with a contraindication to MRI scanning will be excluded unless they are referred for a cardiac CT per clinical standard of practice. These contraindications include patients with the following devices: Central nervous system aneurysm clips Implanted neural stimulator Implanted cardiac pacemaker or defibrillator which are not MR safe or MR conditional according to the manufacturer Cochlear implant Ocular foreign body (e.g. metal shavings) Implanted Insulin pump Metal shrapnel or bullet. Any contraindications to receiving IV gadolinium contrast, determined clinically Subjects where MRI or CT images are acquired more than six months prior to the scheduled surgical date Subjects where date of scan to date of surgery is less than 10 calendar days Subjects where MRI or CT reconstruction is limited due to poor image acquisition as solely determined by the Image Reconstruction Center.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Standard of care (not involving 3D printing) | |
| Experimental: 3D Model<br>3D printed models (at least one rigid blood volume model and one flexible shell model) will be used for surgical planning. | Diagnostic Test: 3D Printed Heart Model<br>* Prior to surgical intervention, the surgeon will be exposed to clinically-indicated images and a patient-specific 3D printed model of the subject's heart anatomy.<br>* Other names: Rapid Prototyped Heart Model;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time under cardiopulmonary bypass |  | peri-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | Up to 30 days post-operative | 
| Intraoperative death or intraprocedural death |  | peri-operative | 
| Unexpected Cardiac arrest during or following procedure |  | From surgical date through 30 days post-operative | 
| Bleeding, Requiring reoperation |  | From surgical date through 30 days post-operative | 
| Sternum left open, Unplanned |  | From surgical date through 30 days post-operative | 
| Unplanned cardiac reoperation |  | From surgical date through 30 days post-operative | 
| Unplanned non-cardiac reoperation |  | From surgical date through 30 days post-operative | 
| Mechanical circulatory support (IABP, VAD, ECMO, or CPS) | Answer yes/no | From surgical date through 30 days post-operative | 
| Arrhythmia necessitating pacemaker, Permanent pacemaker |  | From surgical date through 30 days post-operative | 
| Renal failure (discharge dialysis) | acute renal failure, Acute renal failure requiring dialysis at the time of hospital discharge | From surgical date through 30 days post-operative | 
| Renal failure (temporary dialysis) | acute renal failure, Acute renal failure requiring temporary dialysis with the need for dialysis not present at hospital discharge | From surgical date through 30 days post-operative | 
| Renal failure (hemofiltration) | acute renal failure, Acute renal failure requiring temporary hemofiltration with the need for dialysis not present at hospital discharge | From surgical date through 30 days post-operative | 
| Sepsis | Sepsis (following Society of Thoracic Surgery definition) | From surgical date through 30 days post-operative | 
| Seizure | Seizure (following Society of Thoracic Surgery definition) | From surgical date through 30 days post-operative | 
| Stroke | Stroke (following Society of Thoracic Surgery definition) | From surgical date through 30 days post-operative | 
| Vocal cord dysfunction (possible recurrent laryngeal nerve injury) |  | From surgical date through 30 days post-operative | 
| Other operative/procedural complication | Other operative/procedural complication (following Society of Thoracic Surgery definition) | From surgical date through 30 days post-operative | 
| Technology Assessment | A survey will be given to the surgeons assessing technology acceptance of the 3D printed heart models | Preop, Periop, and up to 30 days a | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D Printing, Rapid prototpying