Table 1 Requirements for informed consent for left ventricular assist device as destination therapy

• Patient

• Surrogate decision maker or medical power of attorney

• Caregiver (spouse, adult child, significant other, etc.)

• Primary care physician

• Palliative care specialist

• Cardiology specialist

• Cardiovascular surgical specialist

• Clergy

• Social services

Information content

• Description of end-stage heart failure disease and natural history

• Description of optimal medical management

• Description of palliative care and symptom management

• Description of hospice services

• Description of surgical procedure for device implantation

• Description of benefits from device implantation over optimal medical management

• Description of complications after device implantation

   ‣ Short-term operative death or complications

   ‣ Expected time of hospitalization and recovery from the surgical procedure

   ‣ Expected survival time after device implantation

   ‣ Expected quality of life (e.g., physical, psychological, social, and financial)

   ‣ Long-term complications

○ Device-related complications

▪Complications after open-heart surgery

▪Neurologic complications

▪Infections

▪Device troubleshooting

▪Device malfunction and failure

▪Pain

▪Noise and sleep-related disorder

○ Concurrent or new clinically significant comorbid conditions and diseases

   ‣ Notification or training of local hospital personnel and doctors

   ‣ Transfer to regional hospitals for inpatient specialized medical care

   ‣ Frequency of regular follow-up visits

   ‣ Frequency of inpatient readmissions

   ‣ Development of new intractable symptoms from right heart failure

   ‣ Advance care planning and documentation (e.g., in event of a stroke, serious infection, device replacement, loss of decision-making capacity, or disseminated malignancy)

   ‣ Anticipated end-of-life trajectories

   ‣ Palliative and hospice care with or without device implantation

   ‣ Device deactivation and death planning (when and where to "turn off" the device)

   ‣ Device procedures in end-of-life organ donation

• Description of short-term and long-term medical care costs with or without device implantation

• Caregiver burden after device implantation

   ‣ Physical

   ‣ Psychological

   ‣ Social

   ‣ Cultural

   ‣ Financial

   ‣ Daily life activities and work or employment

Communication tools

• Face-to-face interviews

• Device patients' support groups

• Caregivers' support groups

• Audiovisual media

• Electronic media (Web sites)

• Printed media (brochures)

Verification of understanding of the relevant information (i.e., the patient and the caregiver should paraphrase the disclosed information)

• Nature of the patient's medical condition

• Nature and purpose of the surgical procedure for device implantation

• Benefits and risks of device implantation

• Benefits and risks of optimal medical management

• Caregiver burden

• Anticipated changes in end-of-life trajectories

• Palliative and hospice care access with or without device implantation

• End-of-life care planning

• Mode of dying and death

Validation of first-person (patient) informed decision making

• Patient acknowledges seriousness of medical condition and likely consequences

• Patient compares medical and device therapies and consequences of each option

• Patient offers reasons for not selecting medical therapy as an option

• Patient offers reasons for selecting device implantation as an option