LVADs as Destination Therapy: When Best Practice Criteria Meets the Real World

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Sophia McDowell
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1 LVADs as Destination Therapy: When Best Practice Criteria Meets the Real World Farooq Sheikh, M.D., FACC Advanced Heart Failure Program MedStar Washington Hospital Center

2 Disclosure I have no relevant financial disclosures.

3 LVADs as Destination Therapy: When Best Practice Criteria Meets the Real World Farooq Sheikh, M.D., FACC Advanced Heart Failure Program MedStar Washington Hospital Center

4 Outline Current status of LVADs as destination therapy (DT) The evolution of best practice criteria in DT: 1. Patient selection 2. Timing of LVAD implantation Viewing LVAD therapy as a permanent or lifelong therapy rather than a destination Improving the patient experience (the benefit of palliative care integration)

5 Slaughter MS et al., NEJM 2009;361: Rose EA et al., NEJM 2001;345: Fang JC, NEJM 2009;361:

6 DT LVAD Implants by Year (INTERMACS) Pinney SP et al., JACC 2017;69: Kirklin JK et al., J Heart Lung Transplant 2017;35:

7 Survival by Implant Strategy (DT vs. BTT) Kirklin JK et al., J Heart Lung Transplant 2017;35:

8 ENDURANCE Trial: HVAD as DT Therapy Rogers JG et al., NEJM;376:

9 Adverse Event Rates Remain High (INTERMACS) INTERMACS Adverse Event Rates (Events/100 patient months) Bleeding 7.8 Infection 7.3 Arrhythmia 4.1 Stroke 1.6 DT strategy is a risk factor for death 3 months post-implant DT 5-year survival 35% Total AE burden is decreasing over time ( vs ) Total Burden 29.2 Kirklin JK et al, J Heart Lung Transplant 2015;34: Kirklin JK et al., J Heart Lung Transplant 2017;35:

10 MedStar LVAD Program: A Real World Experience Implants Patient Characteristics Men 72% AA 66% NICM 67% 19 BTT 50% BTD 11% DT 39%

11 What are Best Practice Criteria and Practices? Feldman D, Pamboukian SV, Teuteberg JJ et al., JHLT 2013;32: Cook JL et al., Circulation 2017;135.

12 Guidelines for DT LVAD Patient Selection (Contraindications) With improvements in benefit/risk ratio, selection criteria are becoming less rigid over time. Absolute Irreversible hepatic, renal, or neurological disease Medical nonadherence Severe psychosocial limitation Advanced RV disease (RV failure risk scores?) Relative Age (>80) Obesity or malnutrition Active infection Severe PVD Active substance abuse Lack of social support Unmanaged psychiatric disorder Cook JL et al., Circulation 2017;135.

13 Lack of Consensus for Psychosocial Requirements Kilic A et al., The VAD Journal 2017, 3.

14 MedStar Experience and Psychosocial Risk Since 2015, ~1 in 4 LVAD recipients have been deemed to be at significant risk for adverse events from a psychosocial standpoint at the time of implant. Can we liberalize our selection criteria and achieve acceptable outcomes? Long term outcomes remain to be determined

15 Psychosocial Features Impact LVAD Outcomes? Affects Mortality Does Not Affect Mortality (only morbidity) VS. Bruce CR. et al., Circ Cardiovasc Qual Outcomes 2017;10. Snipelisky D et al., Am Heart J 2015;170(5):

16 What about DT LVAD Therapy in Less Sick Patients? HMII PA Study INTERMACS (IM) Jorde UP et al., JACC 2014;63: Kirklin JK et al, J Heart Lung Transplant 2015;34:

17 Probability (%) of Death by 1 year Mortality According to Age and Profile Predicted 1 year mortality according to patient age and INTERMACS Profile 65 yrs Years n=12,030 Profile 1 Profile 2 Profiles 3-7 Age at implant (years) Kirklin JK et al., J Heart Lung Transplant 2017;35:

18 ROADMAP Trial Key Points: Non-randomized, observational study (significant differences in baseline characteristics) Primary end point driven by use of delayed LVADs in OMM group (No difference ITT analysis) LVAD recipients are greater risk for AEs (composite AE EPPY 1.89 vs for OMM) Estep JD et al., JACC 2015;66:

19 What does the Patient Want (and When)? Insights from Patient Surveys Stewart GC et al, J Heart Lung Transplant 2009;28: Stewart GC et al., J Heart Lung Transplant 2015;34:

LVAD Implantation is more than a Destination DT Strategy over Time (n=533) The DT/BTT label is a remnant of regulation. Device strategy changes over time.

20 LVAD Implantation is more than a Destination DT Strategy over Time (n=533) The DT/BTT label is a remnant of regulation. Device strategy changes over time. MedStar: ~25% of BTT patients are transplanted after 2 years. Teuteberg JJ et al., JACC HF 2013;1: Improved DT outcomes lead to longer LVAD support and the possibility of transplant for some patients.

21 LVAD Therapy in a World of Scarce Organ Availability Mancini D, Colombo P, JACC 2015;65(23):

22 Metrics Beyond Survival: Improving the DT LVAD Patient Experience Allen LA, Stevenson LW et al., Circulation 2012;125:

Palliative Care Integration MedStar LVAD Program Experience Frequency of PC Interventions (n=32) Medication recommendations Spiritual counseling Disease state education Advance care

23 Palliative Care Integration MedStar LVAD Program Experience Frequency of PC Interventions (n=32) Medication recommendations Spiritual counseling Disease state education Advance care planning completion Psychological counseling Sexual health/intimacy counseling Hospice discussion Change code status 0% 10% 20% 30% 40% 50% 60% 70% 80% Groninger H et al., Manuscript in submission

1. Given improvements in overall survival, DT LVAD therapy will continue to proliferate with a broader AHF population being eligible. Final Thoughts 2.

24 1. Given improvements in overall survival, DT LVAD therapy will continue to proliferate with a broader AHF population being eligible. Final Thoughts 2. In light of the persistent challenges (AEs), the decision to proceed with LVAD implantation requires integration of a patient s values and preferences into the decision process. We need multiinstitutional studies focused on measures of the patient experience. 3. To be considered a viable life-long alternative to transplantation, longer term LVAD survival (5-10 years) must improve. Pinney SP et al., JACC 2017;69:

25 Thank You Special thanks to Steven Boyce, Tonya Elliott, and Samer Najjar. Permission obtained to use this picture.

26 Survival: DT LVAD vs. Medical Therapy Jorde UP et al., JACC 2014;63:

27 Further Insights from ROADMAP LVAD therapy may benefit IM4 pts Self-reported QOL predicts outcome Shah KB et al, J Heart Lung Transplant Stehlik J et al, Circ Heart Failure 2017.

28 Pal-HF Trial Rogers JG et al., JACC 2017;70:

Mechanical assist patient selection, device selection, and outcomes

Mechanical assist patient selection, device selection, and outcomes Josef Stehlik, MD, MPH Associate Professor of Medicine Medical Director, Heart Transplant Program University of Utah School of Medicine