Stratasys 3DHEART
"3D-printed patient-specific models improve surgery, improve outcomes and result in lower treatment costs" - Dr Yoav Dori, Children's Hospital of Philadelphia.
Stratasys is now accepting enrolments for 3DHEART, an investigator-initiated trial to explore the benefits of using 3D-printed heart models in pre-op planning.
3DHEART stands for 3D Hearts Enabling A Randomised Trial. During the single-blind clinical trial, Stratasys will provide in-kind support by printing models to be used in the trial.
Leading the project are physicians from New York – Presbyterian/ Morgan Stanley Children’s Hospital, Children’s Hospital of Philadelphia, Children’s National Medical Center, and Phoenix Children’s Hospital, with up to 20 additional sites in the US. In particular, the study will focus on paediatric congenital heart patients in need of complex two-ventricle repair. The primary endpoint being studied is cardiopulmonary bypass time, with second endpoints including the prevalence of surgical complications, mortality, and physician assessment of utility. OpHeart, a non-profit organisation whose mission is to improve the odds and outcomes with children born with life-threatening heart defects, is managing the study.
Stratasys 3DHEART
Stratasys Direct Manufacturing will 3D print heart models for 200 patients on the Stratasys Connex multi-material, full colour 3D printers.
“This study is incredibly important because it will finally quantify what we know from first-hand experience: 3D-printed patient-specific models improve surgery, improve outcomes and result in lower treatment costs,” said Dr Yoav Dori, Peadiatric Cardiologist, Children’s Hospital of Philadelphia. “If we can empirically demonstrate this, it will be a game-changer for treating not only children with congenital hearts defects, but patients across the board.”
The study will enrol 400 paediatric patients in total. Stratasys Direct Manufacturing will 3D print heart models for 200 patients on the Stratasys Connex multi-material, full colour 3D printers. These models will be patient-specific and based on each individual’s MRI or CT scans. They will enable the surgeons to evaluate and ‘practice’ on an accurate replica of the patient’s heart prior to the actual surgery. The surgical performance and results of these 200 patients will be compared to the other 200 patients who will be treated without the assistance of 3D printed heart models. The 400 patients will not be aware whether their surgery was 3D-assisted or not.
EQUITTEM
Stratasys 3DHEART
Stratasys Direct Manufacturing's 3D heart models will be patient-specific and based on each individual’s MRI or CT scans.
“Stratasys is proud to be part of this historical study which for the first time will provide tier 1 data evidence on the potential benefits of using patient-specific, 3D printed surgical planning models,” said Scott Rader, General Manager, Healthcare Solutions, Stratasys. “We are committed to advancing the use of 3D printing for a variety of medical applications, including anatomical models, medical device prototypes, and prosthetic devices. Gathering this kind of data will raise awareness for the advantages our customers report seeing on an individual patient basis, including better planned surgeries with faster recovery times.”
Greg Reynolds, VP of Additive Manufacturing at Stratasys Direct Manufacturing added: “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.”
