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

From: Ethical challenges with the left ventricular assist device as a destination therapy

Participants
• 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