PURPOSE: The Thoratec Implantable Ventricular Assist Device (IVAD™) is the only FDA-approved intracorporeal biventricular cardiac assist device. It is a titanium-coated version of its predecessor, the Paracorporeal Ventricular Assist Device (PVAD™). The bloodpump is compatible with the portable TLC-II™ driver making home discharge feasible. The purpose of this report is to describe the initial clinical experience with this technology.
METHODS: Nine consecutive patients were implanted with the IVAD™ from June 2005 through March 2006. The indications for support were acute heart failure in six cases and chronic heart failure in three cases. All patients were managed with maximal medical therapies including intravenous inotropic drugs prior to implant.
RESULTS: All patients survived the surgical implant. Six patients were considered successful: three patients discharged to home and subsequently transplanted and two are awaiting transplantation (one at home and one in-house), and one patient was successfully explanted. Three patients expired postoperative of multiple organ system failure (two patients) and pulmonary hemorrhage (one patient). There were no device malfunctions. There was one localized driveline site infection and one thromboembolic event with partial visual loss.
CONCLUSION: The IVAD™ is a unique device capable of providing uni- or bi-ventricular support for either acute or chronic heart failure conditions. Its versatility permits bridge to transplant or recovery options. Home discharge is feasible.
CLINICAL IMPLICATIONS: The IVAD™ system can be used in a variety of clinical scenarios: acute cardiogenic shock and chronic heart failure, uni- or bi-ventricular support, bridge to transplant or recovery, and conceivably as a destination unit. Lastly, it is the only implantable mechanical biventricular system with home discharge capability.
DISCLOSURE: Louis Samuels, None.