Translation of First North American 50 and 70 cc Total Artificial Heart Virtual and Clinical Implantations: Utility of 3D Computed Tomography to Test Fit Devices

Abstract

Since the creation of SynCardia's 50 cc Total Artificial Hearts (TAHs), patients with irreversible biventricular failure now have two sizing options. Herein, a case series of three patients who have undergone successful 50 and 70 cc TAH implantation with complete closure of the chest cavity utilizing preoperative "virtual implantation" of different sized devices for surgical planning are presented. Computed tomography (CT) images were used for preoperative planning prior to TAH implantation. Three-dimensional (3D) reconstructions of preoperative chest CT images were generated and both 50 and 70 cc TAHs were virtually implanted into patients' thoracic cavities. During the simulation, the TAHs were projected over the native hearts in a similar position to the actual implantation, and the relationship between the devices and the atria, ventricles, chest wall, and diaphragm were assessed. The 3D reconstructed images and virtual modeling were used to simulate and determine for each patient if the 50 or 70 cc TAH would have a higher likelihood of successful implantation without complications. Subsequently, all three patients received clinical implants of the properly sized TAH based on virtual modeling, and their chest cavities were fully closed. This virtual implantation increases our confidence that the selected TAH will better fit within the thoracic cavity allowing for improved surgical outcome. Clinical implantation of the TAHs showed that our virtual modeling was an effective method for determining the correct fit and sizing of 50 and 70 cc TAHs.

ISHLT consensus statement for the selection and management of pediatric and congenital heart disease patients on ventricular assist devices Endorsed by the American Heart Association

“…35,36 Device "fit": Innovative imaging techniques using virtual device implantation have become available and evolved as an accepted pre-operative planning tool. [37][38][39][40] This is especially relevant to children that are being considered for a device that has been U.S. Food and Drug Administration (FDA)-labeled for a larger-sized patient. Accurately scaled 3-dimensional (3D) surface rendering of the device are placed within a 3D reconstruction of the chest to assess for individual fit.…”

Insertion of the total artificial heart in the Fontan circulation

“…In addition, the specific morphology of the systemic ventricle(s) and atrioventricular valve anatomy must be understood completely. Computed tomography permits virtual fit testing to determine which pump, if any, will fit the patient (8). It also demonstrates areas of calcification (such as in patch material in the aorta and aortic arch) and any structures at particularly high risk during sternal re-entry.…”

SynCardia total artificial heart opportunities and challenges moving forward

“…The SynCardia t‐TAH is approved for outpatient use that has allowed many patients to be discharged home. Computer tomography of the chest is available as a preimplantation tool that allows the user to perform a virtual 3D implantation to determine which t‐TAH size conforms to patient size and anatomy . Both the 50 and 70 cc t‐TAH have been utilized successfully in children and small patients …”

“…Computer tomography of the chest is available as a preimplantation tool that allows the user to perform a virtual 3D implantation to determine which t-TAH size conforms to patient size and anatomy. 7 Both the 50 and 70 cc t-TAH have been utilized successfully in children and small patients. 8 A number of patients have survived with a TAH for longer than 4 years, prompting SynCardia Systems to develop a DT trial in the United States.…”