LVADS IN AMBULATORY PATIENTS CLASS III PATIENT SHOULD UNDERGO LVAD IMPLANTATION

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Evelyn Ward
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1 LVADS IN AMBULATORY PATIENTS CLASS III PATIENT SHOULD UNDERGO LVAD IMPLANTATION Ajith Nair MD Baylor College of Medicine / Texas Heart Institute American Association for Thoracic Surgery Mechanical Circulatory Support Symposium 2018 THE ARGUMENT FOR LVADS IN AMBULATORY HEART FAILURE PATIENTS

2 LVADS IN NYHA CLASS III PATIENTS? It is difficult to make predictions, particularly about the future Danish proverb Nostradamus Mark Twain Niels Bohr Yogi Berra Better three hours too soon than a minute too late. William Shakespeare

INTERMACS PROFILES 7 6 5 4 3 2 1 1.0% 1.4% 3.0% 14.6% 29.

3 LVAD IMPLANTATIONS ACROSS PROFILES NYHA CLASS III CLASS IIIB CLASS IV (Ambulatory) CLASS IV (Non-ambulatory) INTERMACS PROFILES % 1.4% 3.0% 14.6% 29.9% 36.4% 14.3% % OF IMPLANTS REVIVE-IT ROADMAP (NON-INOTROPE DEPENDENT)

4 OUTCOMES : INTERMACS PROFILES INTERMACS PROFILE AND OUTCOMES Survival to Discharge Length of Stay Boyle A, et al. J Heart Lung Transplant 2011;30:402 7

5 OUTCOMES : INTERMACS PROFILES POST- FDA APPROVAL STUDY WITH CF- ASSIST DEVICES Survival for INTERMACS 1-3 vs % vs 72% for one year 69% vs 60% for two year Jorde UP, et al. J Am Coll Cardiol 2014;63:1751 7

6 AMBULATORY ADVANCED HEART FAILURE INTERMACS PROFILE SHORTHAND DEFINITION 4 RESTING SYMPTOMS At home on oral therapy but with frequent symptoms of congestion at rest or with any activities of daily living 5 EXERTION INTOLERANT Comfortable at rest but unable to engage in any activity, living predominantly within the house or housebound, but without overt congestion 6 EXERTION LIMITED Comfortable at rest without evidence of fluid overload and able to do some mild activities of daily living, but gets fatigued within a few minutes of any meaningful exertion 7 ADVANCED NYHA CLASS III Clinically stable with a reasonable level of comfortable activity, despite history of previous decompensation that is not recent

7 MEDAMACS MEDAMACS 1-year survival rates of ~ 47% IF ambulatory INTERMACS 4 7 patients were reassessed as early as 1 month after their baseline visit, a sizeable minority had worse INTERMACS profiles (21 %), functional capacity as measured by 6-min walk time (29 %) or worsening HF quality of life (29 %), Stewart GC, Kittleson MM, et al. Circ Heart Fail. 2016;9:e003032

8 MEDAMACS Stewart GC, Kittleson MM, et al. Circ Heart Fail. 2016;9:e003032

9 HYPE CYCLE

10 ROADMAP YEAR-ONE RESULTS Estep J, Starling RC, Horstmanshof DA, et al. J Am Coll Cardiol 2015;66:

11 ROADMAP YEAR-ONE RESULTS Estep J, Starling RC, Horstmanshof DA, et al. J Am Coll Cardiol 2015;66:

12 ROADMAP YEAR-ONE RESULTS Estep J, Starling RC, Horstmanshof DA, et al. J Am Coll Cardiol 2015;66:

13 ROADMAP YEAR-ONE RESULTS Estep J, Starling RC, Horstmanshof DA, et al. J Am Coll Cardiol 2015;66:

14 ROADMAP YEAR-ONE RESULTS Estep J, Starling RC, Horstmanshof DA, et al. J Am Coll Cardiol 2015;66:

15 ROADMAP YEAR-ONE RESULTS Estep J, Starling RC, Horstmanshof DA, et al. J Am Coll Cardiol 2015;66:

16 ROADMAP 2-YEAR OUTCOMES SURVIVAL : AS TREATED Starling RC, Estep J, Horstmanshof DA, et al. J Am Coll Cardiol HF 2017;5:518 27

17 SURVIVAL : INTENTION-TO-TREAT ROADMAP 2-YEAR OUTCOMES Starling RC, Estep J, Horstmanshof DA, et al. J Am Coll Cardiol HF 2017;5:518 27

18 ROADMAP 2-YEAR OUTCOMES NYHA CLASS : CHANGES Starling RC, Estep J, Horstmanshof DA, et al. J Am Coll Cardiol HF 2017;5:518 27

19 CUMMULATIVE ADVERSE EFFECTS ROADMAP 2-YEAR OUTCOMES 5 patients

20 ROADMAP 2-YEAR OUTCOMES RISK BENEFIT ANALYSIS Starling RC, Estep J, Horstmanshof DA, et al. J Am Coll Cardiol HF 2017;5:518 27

21 ROADMAP TAKE AWAY Differences in the primary endpoint between LVAD and OMM were primarily due to the use of delayed LVADs in the OMM group. LVAD SURGERY LVAD ADVERSE EFFECTS FUNCTIONAL IMPROVEMENT HR-QOL Intention-to-treat analysis suggests no mortality penalty for either early or delayed use of LVADs in these patients, indicating that factors beyond survival are paramount to decision-making surrounding LVAD implantation in this population.

ADVANCED NYHA CLASS III PATIENT INABILITY TO TOLERATED GDMT RISK SCORES: SEATTLE HEART FAILURE HEART FAILURE SURVIVAL SCORE HEARTMATE RISK SCORE HOSPITALIZATIONS

22 ADVANCED NYHA CLASS III PATIENT INABILITY TO TOLERATED GDMT RISK SCORES: SEATTLE HEART FAILURE HEART FAILURE SURVIVAL SCORE HEARTMATE RISK SCORE HOSPITALIZATIONS FOR HEART FAILURE REDUCED 6MWT (<300m) ADVANCED NYHA CLASS III CARDIORENAL CRT NON-RESPONDERS FRAILTY REDUCED PEAK OXYGEN CONSUMPTION (<14ml/kg/min or < 50% predicted)

23 SHARED DECISION-MAKING DECIDE-LVAD Trial Allen, LA, et al. JAMA Intern Med, 2018.

24 REVIVAL REGISTRY EVALUATION OF VITAL INFORMATION FOR VADs IN AMBULATORY LIFE (REVIVAL) Prospective, observational multicenter patient cohort that has completed enrollment of 400 patients with ambulatory advanced HF across 21 sites in the USA 92% of enrollees in profiles 5 7

25 LVAD THERAPY IN CLASS III PATIENTS Survival Functional Status and QOL Adverse Events LVAD INCREASED FUNCTIONAL STATUS INCREASED QOL ADVANCED NYHA CLASS III SHARED DECISION- MAKING OMM LESS ADVERSE EVENTS LESS HOSPITALIZATIONS?

26 LVADS IN NYHA CLASS III PATIENTS? An expert is a person who has found out by his own painful experience all the mistakes that one can make in a very narrow field. Niels Bohr

Lessons learned from ENDURANCE, ROADMAP, MedaMACS, and how to go forward?

Lessons learned from ENDURANCE, ROADMAP, MedaMACS, and how to go forward? Mark S. Slaughter, MD Professor and Chair Department of Cardiovascular and Thoracic Surgery University of Louisville What could