In table 02R, Replacement of Heart and Great Vessels, new device value L Biologic with Synthetic Substitute, Autoregulated Electrohydraulic, was created as shown below to identify implantation of an autoregulated electrohydraulic total artificial heart system.
|A Heart||0 Open||L Biologic with Synthetic Substitute, Autoregulated Electrohydraulic||Z No Qualifier|
In addition, a new device value M Synthetic Substitute, Pneumatic, was created to identify implantation of a total artificial heart that uses external pneumatic drivers.
|A Heart||0 Open||M Synthetic Substitute, Pneumatic||Z No Qualifier|
The new codes will distinguish between two totally artificial heart systems: SynCardia and Carmat. The SynCardia device is a pneumatically driven pulsatile system and is indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure. The Carmat device is an integrated autoregulated and electrohydraulically driven biocompatible, pulsatile, system intended for full cardiac support. Both systems are inserted using an open approach.