Clinical Impact of Rapid Prototyping 3D Models for Surgical Management

Not Applicable

Withdrawn

• Conditions: Transposition of the Great Arteries; Double Outlet Right Ventricle; Truncus Arteriosus; Congenitally Corrected Transposition of the Great Arteries
• Interventions: Diagnostic Test: 3D Printed Heart Model

• Registration Number: NCT04788082
• Lead Sponsor: Children's National Research Institute

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2017-08-29
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-04
• Last Update Submitted: 2021-03-04
• Study First Posted: 2021-03-09
• Last Update Posted: 2021-03-09
• Primary Completion: 2021-04
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3D Model	3D Printed Heart Model	3D printed models (at least one rigid blood volume model and one flexible shell model) will be used for surgical planning.

Primary Outcome Measures

Name	Time	Method
Time under cardiopulmonary bypass	peri-operative

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Phoenix Children's Hospital; 🇺🇸 Phoenix, Arizona, United States

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States