Patient Discharge (U.S.)

Patient is suffering from end-stage biventricular failure and doctor recommends the Total Artificial Heart as a bridge to transplant.

Patient is implanted with the Total Artificial Heart.

Patient meets criteria to participate in the Freedom driver study.

Patient voluntarily signs informed consent and is enrolled into the Freedom driver study.

Patient and Caregivers are trained how to clean cannulae (driveline) exit sites and change the dressing.

Patient and Caregivers are trained on the operation of the Freedom driver and how to charge and change batteries.

Patient and Caregivers are trained how to recognize and respond to alarms and practice switching to the backup Freedom driver.

Patient and Caregivers demonstrate knowledge and proficiency through written and hands-on tests including:

• Recognition and response to Freedom driver alarms
• Power management of Freedom driver including batteries and external sources of power
• Use and maintenance of Freedom driver and accessories
• Identification and proper reporting of changes in patient status
• Documentation of vital signs and Freedom driver parameters
• Cannulae (driveline) exit site care and dressing change
• Medication schedule and administration
• Schedule of follow-up visits

Patient completes evaluation of the body’s response to exercise.

Patient completes excursions with the Freedom driver.

An assessment of the patient’s home or local residence is conducted to make sure it is a suitable environment for discharge.

Local community resources are notified and trained about the care of the patient including:

• Training of primary care physician, emergency medical responders and the hospital emergency room closest to the patient's home on how to care for the patient implanted with the Total Artificial Heart and supported with the Freedom driver
• Notifying the electric company of the critical nature of maintaining power in the patient’s home

Medications, Guidebook for Patients and Caregivers, backup Freedom driver and accessories are issued to the patient.

Future hospital visits for patient post-discharge are scheduled.

The patient is discharged to home, local residence or intermediate facility to wait for their donor heart transplant.