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Mar 8, 2017 | By Tess

3D printing company Stratasys has announced that enrolment for its new 3DHEART investigative trial is open. The 3DHEART initiative, which stands for 3D Hearts Enabling a Randomized Trial, is a clinical study to see the effects of 3D printed heart models for pre-operative planning for pediatric heart surgery. Stratasys will use its wealth of 3D printing technologies to provide the heart models for the trial.

The 3DHEART study will be led by doctors from the New York-Presbyterian/Morgan Stanley Children’s Hospital, the Children’s Hospital of Philadelphia, the Children’s National Medical Center, and the Phoenix Children’s Hospital. As mentioned, the trial will be geared toward pediatric heart surgery, specifically for pediatric congenital heart patients that require two-ventricle repair.

The goal of the study is to improve factors such as cardiopulmonary bypass time, as well as the risk of surgical complications, mortality, and physician assessment of utility. OpHeart, a nonprofit organization dedicated to improving the conditions and surgical outcomes for children born with potentially fatal heart defects, is in charge of managing the 3DHEART study.

The study will consist of 400 pediatric patients, 200 of whom will be treated with the aid of a 3D printed heart model, made by Stratasys on its Connex multi-material 3D printers. The models will be based on MRI or CT scans from the patients in question, making them accurate replicas of the patient’s heart. The other 200 patients in the study will be treated without the 3D printed heart models.

Dr. Yoav Dori, Pediatric Cardiologist, Children’s Hospital of Philadelphia, said of the trial: “This study is incredibly important because it will finally quantify what we know from firsthand experience: 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.”

Scott Rader, General Manager, Healthcare Solutions, Stratasys, echoed the statement, saying: “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…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.”

3D printed anatomical models are being used more and more for pre-surgical planning. The obvious benefits of using the patient-specific models include giving surgeons an accurate, three-dimensional visualization of what they will be operating on (especially vital in complex cases), and helping to explain surgical procedures to patients. The 3DHEART study will be the first of its kind to provide evidence and data for what effects a 3D printed model can have on pre-operative planning.

“Doctors have seen firsthand how 3D printing can save lives, but have not had the resources to quantifiably substantiate heretofore anecdotal evidence. This study will do that,” commented OpHeart Executive Director, Anne Garcia.

 

 

Posted in 3D Printing Application

 

 

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