1. Advanced Therapies Lee R. Goldberg, MD, MPH Medical Director, Heart Failure and Cardiac Transplant Program University of Pennsylvania

2. What Are Advanced Therapies? Heart Transplant Ventricular Assisted Devices (VAD) – Mechanical Circulatory Support (MCS)

3. The Paradox Sick enough to need transplant or VAD without any other threatment options Well enough to survive VAD and/or transplant and have good quality of life Desperately sick and otherwise healthy at the same time! For Transplant, limited organ availability creates a societal responsibility to carefully select recipients most likely to survive and have a good quality of life

4. The Evaluation – Three Components The Heart – There are no other therapies that will improve the status of the heart, survival or quality of life The rest of you – All the organs except the heart are healthy and can survive the surgery and the effects of either the VAD or the medications after transplant Everything outside of you – “Family” support – Psychosocial – Transportation – Finances, insurance, disability, prescription coverage

5. Timing Move forward with VAD or Transplant before irreversible organ damage, malnutrition, muscle weakness or infection Avoid going “too soon” – “Up front risk” – can shorten life – New therapies always being developed and improved Can use VAD as bridge to heart transplant – Correct heart failure – Better candidate when it comes time to transplant

6. Transplant Wait List The current UNOS system divides the waiting list by “risk of death” – Status 1A – On IV medications at high dose with a monitoring (PA) catheter, VAD complication, 30 days following VAD – Status 1B – On IV medication or VAD – Status 2 – Not on IV medications or VAD – Status 7 – Inactive Body Size Blood Group Antibodies (PRA)

7. Heart Transplant Rejection versus infection Immunosuppression – Calcineurin inhibitor (Tacrolimus, Cyclosporine) – Anti-proliferative (Mycophenolate mofetil, azathiprine – Steroid (Prednisone) Immunosupporession issues – Must take for life – Increases risk of infection – Increases risk for cancers – Toxicity to kidneys – Other side effects – tremor, GI, weight gain, diabetes Frequent visits – Weekly, biweekly, monthly in first year – Heart biopsies, blood draws, frequent adjustment of medications

8. Ventricular Assist Device Need to take anticoagulation (blood thinners) for life – Risk of clot in VAD – Risk of bleeding especially in GI tract – Risk of stroke – clots and bleeding Infection – Drive line infections Blood pressure control – Challenging – No pulse! Tethered to batteries – Can impact travel – need to plan ahead

9. Palliative Care For people who are not candidates or who do not want advanced therapies – Focus on quality of life and symptom control – Define wishes for heroic therapies – CPR, Shocks from ICD device, admission to hospital For people who have had advanced therapies – Define goals of care – When to deactivate VAD

10. Conclusion Advanced therapies include ventricular assist devices and heart transplants You need to be “sick” and “healthy” at the same time to really benefit from these therapies A comprehensive evaluation is necessary to determine who is a good candidate Each therapy has advantages and disadvantages Communicating your wishes and goals to your family and clinical team is critical