Center for Advanced Heart Therapies Ventricular Assist Device (VAD) and Transplant Evaluation Informed Consent Welcome to our program. We have developed this document to help you understand the evaluation process for advanced heart therapies. Please note that every patient situation is different and there may be exceptions and variations to the process we have outlined. You are being evaluated for VAD as either Destination Therapy (DT) or Bridge to Transplant (BTT) Therapy. Please ask if you are unsure which type of therapy is being recommended for you. Our Team Advanced Heart Failure/Transplant Cardiologist: Dr. Phillip Habib Cardiothoracic VAD/Transplant Surgeon: Dr. Brian Bethea VAD/Transplant Coordinator: Meghan Ciganik, BSN, RN, CHFN Office Manager/Scheduler/Medical Assistant: Diane Hartel The evaluation process for advanced heart therapies includes heart transplant and ventricular assist devices. This involves a step wise approach and includes our multidisciplinary team. The evaluation period can vary in length from several days to weeks depending on the stage of your heart disease, type of insurance coverage and other diseases you have. Phases of Evaluation Phase 1 testing includes advanced cardiology testing to stage your heart disease and provides financial education and assessment of your ability to meet the requirements for each type of therapy. The consults during this part of the evaluation are a mandatory part of the process. Phase 1 Testing (including but not limited to): Initial Consult with the Advanced Heart Failure Cardiologist Financial Consult VAD/Transplant Coordinator Consult Chest X-ray 2D Echocardiography 6 Minute Walk Test Cardiac Viability Study Cardiopulmonary Exercise Stress Test Right Heart Catheterization 12 Lead EKG Heart Failure Questionnaires Laboratory Testing Page 1 of 4 Center for Advanced Heart Therapies Ventricular Assist Device (VAD) and Transplant Evaluation Informed Consent Financial Consult: A financial representative of Delray Medical Center will meet with you early in the evaluation process to help you understand your advanced heart failure benefits related to your insurance coverage. They will explain your coverage and help you figure out if you can afford any copayments associated with VAD or transplant. It is very important that you give them the information required so that they can help you. They will be asking very personal and detailed information about your background and finances. This information will be kept strictly confidential. There are usually associated copayments for VAD dressings, cardiac rehabilitation visits and transplant medications in addition to miscellaneous costs such as transportation to and from clinic. The financial coordinators are skilled at exploring ways to help you become eligible for these expensive therapies. VAD/Transplant Coordinator Consult: Our VAD Coordinators are specialized nurses trained in the management of patients with VADs and heart transplants. They are experienced with VAD and transplant patients and have extensive knowledge and understanding regarding the requirements needed for a patient and their support system to be successful with a VAD or transplant. They will assess you and your caregiver’s ability to learn how to take care of a VAD including equipment, recognizing and responding to alarms, emergency management and dressing changes. They will help you understand any restrictions that you may have after VAD or transplant. These nurses will become your life line to the program should you end up with a VAD or transplant. The education process for VAD and transplant begins with extensive pre-education with the VAD/Transplant Coordinator. You must be willing to participate in this process to be considered for advanced therapies. Phase 2 Testing (including but not limited to): Cardiothoracic Surgery Consult Palliative Care Consult Psychosocial Consult (Social Work) Physical Therapy Consult Infectious Disease Consult Nutrition Consult Other Consults depending on disease processes present: Psychiatry, Gastroenterology, Neurology, Nephrology, Endocrine, Dermatology, and Ophthalmology, others as deemed medically necessary Laboratory Testing Colonoscopy within 5 years Chest CT Head CT DEXA Scan Pulmonary Function Testing Page 2 of 4 Center for Advanced Heart Therapies Ventricular Assist Device (VAD) and Transplant Evaluation Informed Consent Carotid Doppler Studies ABI Testing Abdominal Ultrasound Routine Health Screening: PAP, Prostate, Mammogram, Dental (records need to be sent to our office) Palliative Medicine Consult: During your evaluation for advanced heart therapies you will meet with our Palliative Care team. The purpose of the palliative care consult is to define a “Preparedness Plan”. We discuss with you and your loved ones your understanding of your disease and create a specific advanced directive aligning medical treatment options with your goals of care. A conversation regarding expected benefits and potential burdens will be used to document your goals, values and preferences. Social Work Consult: Social workers involved with the VAD Program will help patients and their family understands the procedure and assist with individual and social situations. The social worker will assess the patient’s strengths, coping abilities, resources, and areas of concern regarding the patient’s ability to undergo the VAD implant procedure. The social worker uses therapeutic skills and community resources to help the patient and their family during the evaluation, surgery and recovery. Additionally, the social worker will conduct an evaluation to ensure the necessary resources are available for the patient during their recovery. They will meet with the patient’s family and caregivers to provide support and resources. They help find financial resources and housing resources, and help the patient and their family cope with the imperative life-changing decision. Nutrition Consult: The role of the clinical dietitian is to analyze and assess your current nutritional status. In efforts to do this, a nutrition assessment will be conducted with you and your caregiver. The nutrition assessment includes, but is not limited to the following components: Review height and weight history Obtain nutrition history (appetite, oral intake, diet followed at home, use of supplements, medications, food preferences) Assessment of current nutrition-related lab values Review of pre and post op diet guidelines Provide any diet education Establish a nutrition plan of care The dietitian will continue to work closely with you, your caregivers and the entire interdisciplinary team to ensure your nutrition plan of care is followed throughout this process. Selection Process After your evaluation is complete your case will be presented to our multidisciplinary VAD and transplant team for approval, denial or deferment. A VAD/Transplant Coordinator will notify you of the Page 3 of 4 Center for Advanced Heart Therapies Ventricular Assist Device (VAD) and Transplant Evaluation Informed Consent committee decision by standard mail. If you would like information prior to the arrival of your letter feel free to contact your coordinator. Our selection committee meets on Wednesdays. In addition to our selection process, we have partnered with a heart transplant center. Your case will also need to be presented to our affiliated transplant center before a final decision is made. This process may take up to a week after our selection meeting. If you are deferred for additional testing or an extended observation period you will be notified with specific instructions on your eligibility requirements. Failure to follow these requirements will result in the denial of your case. Special Circumstances for Bridge to Transplant Patients If you have been accepted for VAD as a Bridge to Transplant (BTT) patient, there are transplant listing requirements from our affiliated transplant centers that you must meet. We will provide documentation of these requirements for you with your acceptance letter. If you do not comply with these requirements you may be removed from the heart transplant waitlist. Please call you coordinator if you do not understand these requirements. We will make every effort to accommodate you during the evaluation process. We understand that from time to time things come up that may prevent you from keeping your appointments. In order to be successful with a VAD, patients need to commit to following instructions and being compliant with medications and appointments. Please let us know if you are struggling to make your appointments and take your medications. I ___________________________________ have read the information in this document regarding the evaluation process for Ventricular Assist Device/Transplant. I understand the evaluation process and my questions have been answered at this time. _____________________________________________ _________________________ Patient Name Date Page 4 of 4