Stratasys is to produce 3D printed heart models for use in 3D Hearts Enabling A Randomized Trial (3DHEART)—a randomized, single-blind clinical trial supported by its corporate social responsibility (CSR) program to examine the use of patient-specific 3D printed heart models in preoperative pediatric heart surgery planning.
3DHEART is managed by OpHeart—a nonprofit organization aiming to improve the odds and outcomes for children born with life-threatening heart defects—and led by physicians from the Children’s Hospital of Philadelphia, Children’s National Medical Center, New York-Presbyterian/Morgan Stanley Children's Hospital and Phoenix Children’s Hospital.
The trial will focus on pediatric congenital heart patients requiring complex two-ventricle repair. Its primary endpoint is cardiopulmonary bypass (CBP) time and secondary endpoints include the prevalence of surgical complications, mortality and physician assessment of utility.
Four-hundred patients are sought for 3DHEART and enrollment has just opened. Stratasys Direct Manufacturing—Stratasys’s 3D printing and advanced manufacturing services division—will 3D print heart models for 200 of the patients using the company’s Connex3 multi-material, full-color 3D printers.
The models will be produced from the patients’ MRI or CT scans, providing surgeons with an accurate replica to evaluate and practice on prior to actual surgery. The results of these 200 patients are to be compared with the results of the 200 patients who are treated without the aid of 3D printed heart models.
Dr. Yoav Dori, pediatric cardiologist at Children’s Hospital of Philadelphia, said: ‘This study is incredibly important because it will finally quantify what we know from firsthand experience, [that] 3D printed patient-specific models improve surgery, improve outcomes and result in lower treatment costs. If we can empirically demonstrate this, it will be a game-changer for treating not only children with congenital heart defects, but patients across the board.’
Greg Reynolds, vice president (VP) of additive manufacturing at Stratasys Direct Manufacturing, further commented: ‘Stratasys Direct Manufacturing is honored to contribute to such an impactful study with the potential to revolutionize surgical planning and change patients’ lives for the better. We understand the critical nature of this work and we’ve worked with the study investigators to develop a robust and responsive production process that puts these models in surgeons’ hands in as little as three days.’