Clinical Impact of Rapid Prototyping 3D Models for Surgical Management

Transposition of the Great Arteries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04788082
• Other study ID #: 15-090
• Status: Withdrawn
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: June 2021

Study information

• Verified date: March 2021
• Source: Children's National Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pediatric subjects undergoing primary complex two-ventricle repair of congenital heart defect, including but not limited to:

1. double outlet right ventricle (DORV),

2. transposition of the great arteries with ventricular septal defect and pulmonary stenosis (TGA/VSD/PS),

3. truncus arteriosus with ventricular septal defect (TA/VSD)

4. 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

1. complete or transitional atrioventricular canal

2. double inlet left ventricle

3. tricuspid atresia

4. 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:

1. Central nervous system aneurysm clips

2. Implanted neural stimulator

3. Implanted cardiac pacemaker or defibrillator which are not MR safe or MR conditional according to the manufacturer

4. Cochlear implant

5. Ocular foreign body (e.g. metal shavings)

6. Implanted Insulin pump

7. Metal shrapnel or bullet.

8. 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.

Related Conditions & MeSH terms

• Congenitally Corrected Transposition of the Great Arteries
• Double Outlet Right Ventricle
• Situs Inversus
• Transposition of Great Vessels
• Transposition of the Great Arteries
• Truncus Arteriosus
• Truncus Arteriosus, Persistent

Intervention

Diagnostic Test:
• 3D Printed Heart Model
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.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Children's National Research Institute	Children's Hospital of Philadelphia, Phoenix Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (24)

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Costello JP, Olivieri LJ, Krieger A, Thabit O, Marshall MB, Yoo SJ, Kim PC, Jonas RA, Nath DS. Utilizing Three-Dimensional Printing Technology to Assess the Feasibility of High-Fidelity Synthetic Ventricular Septal Defect Models for Simulation in Medical Education. World J Pediatr Congenit Heart Surg. 2014 Jul;5(3):421-6. doi: 10.1177/2150135114528721. — View Citation

Costello JP, Olivieri LJ, Su L, Krieger A, Alfares F, Thabit O, Marshall MB, Yoo SJ, Kim PC, Jonas RA, Nath DS. Incorporating three-dimensional printing into a simulation-based congenital heart disease and critical care training curriculum for resident physicians. Congenit Heart Dis. 2015 Mar-Apr;10(2):185-90. doi: 10.1111/chd.12238. Epub 2014 Nov 11. — View Citation

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Ejaz F, Ryan J, Henriksen M, Stomski L, Feith M, Osborn M, Pophal S, Richardson R, Frakes D. Color-coded patient-specific physical models of congenital heart disease. Rapid Prototyping Journal 20(4): 336-343, 2014.

Gelijns AC, Moskowitz AJ, Acker MA, Argenziano M, Geller NL, Puskas JD, Perrault LP, Smith PK, Kron IL, Michler RE, Miller MA, Gardner TJ, Ascheim DD, Ailawadi G, Lackner P, Goldsmith LA, Robichaud S, Miller RA, Rose EA, Ferguson TB Jr, Horvath KA, Moquete EG, Parides MK, Bagiella E, O'Gara PT, Blackstone EH; Cardiothoracic Surgical Trials Network (CTSN). Management practices and major infections after cardiac surgery. J Am Coll Cardiol. 2014 Jul 29;64(4):372-81. doi: 10.1016/j.jacc.2014.04.052. — View Citation

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Kim MS, Hansgen AR, Wink O, Quaife RA, Carroll JD. Rapid prototyping: a new tool in understanding and treating structural heart disease. Circulation. 2008 May 6;117(18):2388-94. doi: 10.1161/CIRCULATIONAHA.107.740977. Review. — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time under cardiopulmonary bypass		peri-operative
Secondary	Mortality		Up to 30 days post-operative
Secondary	Intraoperative death or intraprocedural death		peri-operative
Secondary	Unexpected Cardiac arrest during or following procedure		From surgical date through 30 days post-operative
Secondary	Bleeding, Requiring reoperation		From surgical date through 30 days post-operative
Secondary	Sternum left open, Unplanned		From surgical date through 30 days post-operative
Secondary	Unplanned cardiac reoperation		From surgical date through 30 days post-operative
Secondary	Unplanned non-cardiac reoperation		From surgical date through 30 days post-operative
Secondary	Mechanical circulatory support (IABP, VAD, ECMO, or CPS)	Answer "yes"/"no"	From surgical date through 30 days post-operative
Secondary	Arrhythmia necessitating pacemaker, Permanent pacemaker		From surgical date through 30 days post-operative
Secondary	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
Secondary	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
Secondary	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
Secondary	Sepsis	Sepsis (following Society of Thoracic Surgery definition)	From surgical date through 30 days post-operative
Secondary	Seizure	Seizure (following Society of Thoracic Surgery definition)	From surgical date through 30 days post-operative
Secondary	Stroke	Stroke (following Society of Thoracic Surgery definition)	From surgical date through 30 days post-operative
Secondary	Vocal cord dysfunction (possible recurrent laryngeal nerve injury)		From surgical date through 30 days post-operative
Secondary	Other operative/procedural complication	Other operative/procedural complication (following Society of Thoracic Surgery definition)	From surgical date through 30 days post-operative
Secondary	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

External Links

•   Children's National Medical Center
•   Phoenix Children's Hospital's 3D Print Lab