3D Models Inform Presurgical Planning for VAD Placement

UH participates in international study to improve outcomes in patients with congenital heart disease and heart failure

Innovations in Cardiovascular Medicine & Surgery | Winter 2020

Pradeepkumar Charla, MD

Thanks to advanced surgical palliation and skillful medical management, most patients born with congenital heart disease (CHD) are living into adulthood. However, one-quarter of patients with complex CHD will progress to heart failure (HF) by age 30.

Placement of a ventricular assist device (VAD) can improve symptoms and quality of life or provide a bridge to transplant. But utilization of VAD in patients with CHD and HF remains rare, due in part to the highly variable anatomy and complex physiology in this population. This is true despite recent reports of outcomes being similar to those for patients without CHD.

Utilization of 3-D models of the heart has the potential to play a critical role in helping surgeons visualize the cardiac anatomy prior to surgical or percutaneous intervention. These models provide a physical guide to patient-specific anatomic features that can make VAD and cannula placement challenging.

IMMPACT TRIAL

Sponsored by Columbia University, the IMMPACT trial (Implementing Models for Mechanical Circulatory Support Presurgical Assessment in Congenital Heart Disease Treatment) is a multicentered study of the use of 3-D-printed heart models for presurgical planning in children and adults with CHD who have been diagnosed with clinical HF and will undergo VAD placement. University Hospitals Cleveland Medical Center is the only site in Northeast Ohio — and one of 12 sites internationally — partnering with Columbia University for the trial.

“The primary aim is to establish the potential utility and potential advantage for surgeons using 3-D-printed cardiac models for presurgical planning of VAD placement in CHD-HF patients,” says Pradeepkumar Charla, MD, Director, Adult Congenital Heart Disease Center, University Hospitals Harrington Heart & Vascular Institute, and Assistant Professor, Case Western Reserve University School of Medicine. “Studying the anatomy preoperatively should help surgeons determine which mechanical circulatory support device is best suited for each patient and analyze VAD canalization.”

DEVELOPING TRIAL DATA

Currently, surgeons rely on advanced imaging techniques, including cardiac magnetic resonance or cardiac computed tomography, to visualize abnormal structures within the heart. There are limitations, however, to viewing the images on 2-D screens. To produce each patient-specific 3-D model, a dataset must be developed via segmentation of MRI images to first create a virtual 3-D model, which is then printed in a process known as rapid prototyping. For the IMMPACT study, participating sites will send image sets to Columbia University, where researchers will translate, print and return each 3-D model prior to surgical or percutaneous intervention.

Central to the investigation is whether having preoperative access to 3-D cardiac modeling improves visualization of VAD and cannula placement sites. Participating surgeons will complete a questionnaire after viewing 2-D imaging and again after viewing the patient-specific physical replica. Patient outcomes at set time intervals also will be compared against control procedures completed without 3-D modeling.

The study, which runs through July 2024 and has a target enrollment of 30 participants, is open to patients age 13 and older with a diagnosis of CHD-HF who are candidates for mechanical circulatory support. “In the field of cardiology, technology and innovation advance rapidly,” says Dr. Charla. “We are always searching for ways to offer our patients greater opportunities to live long and healthy lives.”

For more information, or to volunteer or refer a patient for this study, please contact Dr. Charla at 216-553-1537 or email Peds.Innovation@UHhospitals.org.