Anatomic fit study for development of a one piece total artificial heart.

A fit study was conducted to define anatomic constraints to total artificial heart (TAH) insertion in 26 human orthotopic cardiac transplant recipients, and the parameters necessary for designing a totally implantable TAH were obtained from the excised heart. A multiadjustable fitting device was made (height, 118 mm; width, 81 mm; diameter, 97 mm), and with this model, 15 fitting and measuring studies were conducted to validate the design and demonstrate anatomic compatibility. Satisfactory fit of the contour model was observed in all cases. The model was placed through a sternotomy wound in the pericardial space. In addition to this mock-up fit study, the anatomic dimensions of the connection points to the TAH and the excised hearts also were measured. With the prototype model based on these data, a fit verification study was done in 11 recipients. Satisfactory fit in the pericardial space without compression of adjacent structures was observed in seven of 11 patients. This study suggests that the newly designed model of an anatomically and surgically practical configuration could be implanted in most patients in this population as a completely implantable cardiac prosthesis.