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What have we learned? What is next? Panel B: Functional Capacity,

Research Topics in INTERMACS. What have we learned? What is next? Panel B: Functional Capacity, Quality of Life and Outcomes H. Functional Capacity I. Neurocognitive Assessment J. Quality of Life K. Terminal Events and Risk Factors L. Discussion.

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What have we learned? What is next? Panel B: Functional Capacity,

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  1. Research Topics in INTERMACS What have we learned? What is next? Panel B: Functional Capacity, Quality of Life and Outcomes H.Functional Capacity I. Neurocognitive Assessment J. Quality of Life K. Terminal Events and Risk Factors L. Discussion INTERMACS Annual Meeting March 2012

  2. Research Topics in INTERMACS Functional Capacity JoAnn Lindenfeld So far we have learned little about functional capacity INTERMACS Annual Meeting March 2012

  3. June 2006 – Sept 2008: Adult Prospective Implants Pt Seen in 6 Minute WalkVO2 Max R at Peak Follow-up Hospital/Clinic n % n % n % Pre-Implant 957 30 3.1% 58 6.1% 28 2.9% 3 Month 426 79 18.5% 14 3.3% 12 2.8% 6 Month 202 38 18.8% 10 5.0% 8 4.0% 12 Month 71 16 22.5% 1 1.4% 0 ­ 18 Month 16 3 18.8% 0 - 0 - 24 Month 3 1 33.3% 0 - 0 - Total 1675 167 10.0% 83 5.0% 48 2.9% INTERMACS Annual Meeting March 2012

  4. Is Frailty Predictive of Hospital Complications, Duration and Success of Rehabilitation, and Ultimate Quality of Life? INTERMACS Annual Meeting March 2012

  5. Frailty Increased Vulnerability to Stress LVAD-Responsive Frailty LVAD-Independent Frailty Systolic and diastolic dysfunction Inflammation Anorexia Hypoxia Polypharmacy AGING COPD / lung disease Cancer Diabetes Osteoporosis Peripheral vascular disease Cirrhosis Neurologic disease ↑PCWP and CVP ↓Cardiac output Sarcopenia Malnutrition Cognitive deficits Injurious falls Impaired Health Status Disability Loss of ADLs Institutionalization Post-Operative Complications Prolonged LOS Need for ICU care Reduced Survival INTERMACS Annual Meeting March 2012 Flint et al Circ: Heart Failure In Press

  6. LVAD-Independent Frailty LVAD-Responsive Frailty Patient A Patient B Patient C Pre-LVAD Frailty Post-LVAD Frailty INTERMACS Annual Meeting March 2012 Favorable Outcome Lower risk for premature death or complications, with marked improvement in functional status Intermediate Outcome Moderate risk for premature death and complications with some persistent functional limitation Unfavorable Outcome High risk for premature death and complications with failure to improve functional status Flint et al Circ: Heart Failure In Press

  7. Research Topics in INTERMACS • Functional Capacity • Can we improve collection of functional capacity data? • How much does functional capacity improve in LVAD recipients? • What limits improvements in functional capacity? • Can we measure gait speed in a high percentage of patients? • Does gait speed add to the ability to predict mortality? • Does gait speed add to the ability to predict post-operative complications and length of stay? • Can we measure frailty using gait speed alone or combined with other parameters (weight loss, albumin, anemia, etc) in the database? • Can we predict reversible frailty? INTERMACS Annual Meeting March 2012

  8. Research Topics in INTERMACS • Functional Capacity • Is gait speed predictive in those < 60 years? • Do any of these measures of functional capacity predict QoL? • What are the predictors of return to good functional capacity? • What are the best measures of frailty in end-stage heart failure? • How do we determine if frailty is reversible? INTERMACS Annual Meeting March 2012

  9. Research Topics in INTERMACS Neurocognitive Assessment K Grady INTERMACS Annual Meeting March 2012

  10. Research Topics in INTERMACS • What have we learned? • There are challenges to data collection for assessing neurocognitive function via the Trail Making Part B • e.g., patient and coordinator burden, as it is directly administered to the patient by an examiner • Data collection for the Trail Making Part B has been poor • There are no INTERMACS abstracts/publications to date • What is next? • Consider adding an expert (i.e., champion) in neurocognitive assessment to the INTERMACS QOL Committee and examine next steps to enhance data collection. INTERMACS Annual Meeting March 2012

  11. Research Topics in INTERMACS • Neurocognitive Assessment • The biggest challenges with neurocognitive assessment in INTERMACS are: • Collecting the Data • Making neurocognitive assessment a part of MCSD standard of care INTERMACS Annual Meeting March 2012

  12. Research Topics in INTERMACS • Neurocognitive Assessment • What are the Next Steps? • Improving Patient Outcomes • Device Evaluation and Development INTERMACS Annual Meeting March 2012

  13. Research Topics in INTERMACS Quality of Life K Grady INTERMACS Annual Meeting March 2012

  14. QOL Instrument EQ-5D Health Questionnaire English version for the US Mobility I have no problems in walking about q I have some problems in walking about q I am confined to bed q Self-Care I have no problems with self-care q I have some problems washing or dressing myself q I am unable to wash or dress myself q Usual Activities (e.g. work, study, housework, family or leisure activities) I have no problems with performing my usual activities q I have some problems with performing my usual activities q I am unable to perform my usual activities q Pain/Discomfort I have no pain or discomfort q I have moderate pain or discomfort q I have extreme pain or discomfort q Anxiety/Depression I am not anxious or depressed q I am moderately anxious or depressed q I am extremely anxious or depressed q INTERMACS Annual Meeting March 2012

  15. N=878 adult MCS patients, primary implant (pulsatile and continuous flow [LVAD, Bi-VAD, TAH]: 6/06-9/08); Profile 1 = 36%, Profile 2 = 38% Pre and Post Implant EQ-5D (primary implant, prospective, adult) Visual Analogue Scale (VAS) Across Time (mean ± SD) Best (N=39) (N=96) (N=183) EQ-5D VAS (N=312) P (pre vs 3 mo) <0.001 Worst INTERMACS Annual Meeting March 2012 Pre-Implant 3 month 6 month 12 month Months Post Implant

  16. CONCLUSIONS • Quality of life was poor before MCS implant and improved significantly from before to after MCS implant. • The frequency of problems in the areas of mobility, self-care, usual activities, and anxiety / depression decreased from before to after MCSD implantation. • The frequency of pain / discomfort was similar before and after MCSD implantation. • “Some problems” were reported more frequently than “extreme problems” in all QOL domains after MCSD implant. • Differences in QOL before and after MCSD implantation were identified by gender and age. INTERMACS Annual Meeting March 2012

  17. PURPOSE • To examine differences in HRQOL scores, among INTERMACS profiles, both before and at 3, 6, and 12 months after implant • To examine patterns of HRQOL scores from before MCS implant through 1 year after implant, by INTERMACS patient profiles • Definition: Health-related Quality of Life • “The functional effect of an illness and its consequent therapy upon a patient as perceived by the patient.” • HRQOL Domains: mobility, self-care, usual activities, anxiety / depression, pain / discomfort, & perception of overall health status • Schipper H, in Spilker B (ed) Quality of Life Assessment in Clinical Trials (1990) INTERMACS Annual Meeting March 2012

  18. Implants: June 2006 – March 2010, Follow-up: March 2011 Primary continuous flow LVAD, n=1559 Patient Profile Levels (Pre-Implant) Status at 1 year 1 2 3 4 5-7 Total Post implant (n= 262) (n=695) (n=330) (n=175) (n=97) (n=1559) Death 21% 16% 9% 14% 12% 15% Transplant 36% 32% 37% 33% 29% 34% Recovery 2% 1% 0% 0% 1% 1% Alive (on device)* 41% 51% 54% 53% 58% 50% Total 100% 100% 100% 100% 100% 100% * Available for quality of life assessment at 1 year post implant INTERMACS Annual Meeting March 2012

  19. June 2006 – March 2011: HRQOL by Patient Profiles (All patients with opportunity for 1 year follow-up (n=1559) Alive (device in place) 100% Alive (device in place) 83% Alive (device in place) 69% Alive (device in place) 50% Proportion of Patients Txpl 34% Txpl 19% Dead 9% Dead 11% Txpl 8% Dead 15% Rec 1% Rec 1% Rec 0% Txpl 0% INTERMACS Annual Meeting March 2012 Dead 0% Rec 0% Pre-implant Months Post Implant

  20. EQ-5D: Visual Analog Scale Primary Continuous Flow LVADs, n=2807 Best Health Mean VAS Worst Health INTERMACS Annual Meeting March 2012 INTERMACS Patient Profile Levels

  21. EQ-5D: Mobility, Any Problems Primary Continuous Flow LVADs, n=2807 % Patients with Any Mobility Problems INTERMACS Annual Meeting March 2012 INTERMACS Patient Profile Levels

  22. EQ-5D: Self Care, Any Problems Primary Continuous Flow LVADs, n=2807 % Patients with Any Self Care Problems INTERMACS Annual Meeting March 2012 INTERMACS Patient Profile Levels

  23. Predictors of better QOL at 6 months after continuous flow MCS • Since the mean VAS score improved dramatically from pre-implant to 6 months post implant (42 vs 74, p< 0.0001), the most important factor for increased overall health status was MCS implant. INTERMACS Annual Meeting March 2012

  24. Research Topics in INTERMACS • Quality of Life • What are the Next Steps? • Improving Patient Outcomes • Device Evaluation and Development INTERMACS Annual Meeting March 2012

  25. What is next? • Identify preoperative psychosocial stress factors (e.g., poor QOL, social isolation, education) as predictors of outcomes in women and men after primary continuous flow LVAD implant. • Longitudinal change in HRQOL (EQ-5D re 5 dimensions + VAS and KCCQ) from before to 12, 24, and 36 months after MCS • - Overall • - By demographic characteristics (i.e., age, gender) • - By pre implant INTERMACS profile • - By implant strategy (i.e., DT, BTT, BTR) • Risk factors for poor HRQOL outcomes at 12, 24 and 36 months after continuous flow LVAD implant • DVs: EQ-5D VAS and 5 dimensions, EQ-5D index • KCCQ (including domains and summary scores) • IVs: Demographic factors (e.g., age, gender, education) • Clinical factors • pre (e.g., INTERMACS profiles, co-morbidities) • post (e.g., adverse events) • Other risk factors (e.g., stress, coping, self-efficacy) • Analyses of specific domains of interest (e.g., social support, self-efficacy, symptom frequency / burden, etc.) • Utility analyses, QALYs, etc. INTERMACS Annual Meeting March 2012

  26. Research Topics in INTERMACS Terminal Events and Risk Factors D Naftel INTERMACS Annual Meeting March 2012

  27. INTERMACS: Survival After LVAD Implant Continuous Flow Intracorporeal Device n=896, deaths=112 Pulsatile Flow Intracorporeal Device, n=470, deaths=140 Pulsatile Flow Paracorporeal Device, n=74, deaths=28 % Survival p (overall) < 0.0001 Event: Death (censored at transplant or recovery) INTERMACS Annual Meeting March 2012 Months after Device Implant

  28. INTERMACS: Survival After LVAD Implant Survival after Primary LVAD (Pulsatile and Continuous Flow Devices) Survival Months % Survival 1 mo 94% 3 mo 89% 6 mo 84% 12 mo 76% 24 mo 63% % Survival Deaths / Month (Hazard) Hazard Event: Death (censored at transplant or recovery) INTERMACS Annual Meeting March 2012 Months after Device Implant

  29. INTERMACS: Survival after LVAD Implant Adult Primary Pulsatile Intracorporeal Flow LVAD Pumps (n= 470) By Age Groups < 30 years, n=27, deaths=5 30 – 65 years, n=377, deaths=100 % Survival 65+ years, n=66, deaths=35 P (overall) <.0001 Event: Death (censored at transplant or recovery) INTERMACS Annual Meeting March 2012 Months after Device Implant

  30. INTERMACS: Survival after LVAD Implant Adult Primary Continuous Intracorporeal Flow LVAD Pumps: n= 896 By Age Groups < 30 years, n=61, deaths=2 30 – 65 years, n=691, deaths=81 65+ years, n=144, deaths=29 % Survival P (overall) = .002 Event: Death (censored at transplant or recovery) INTERMACS Annual Meeting March 2012 Months after Device Implant

  31. INTERMACS: Survival After LVAD Implant Adult Primary Intracorporeal LVADs (n=1366) Early Constant Risk Factor Hazard ratio p-value Hazard ratio p-value Female 1.71 0.04 --- --- Age (older) 1.141 0.006 1.131 0.008 Previous CABG 2.71 <0.0001 --- --- Previous Valve Surgery 1.99 0.01 --- --- Dialysis (current) 2.45 0.01 --- --- INR (higher) 1.492 0.003 --- --- Ascites 2.32 0.002 --- --- RVEF: Severe --- --- 2.33 0.04 RA Pressure (higher) 1.523 0.02 --- --- Cardiogenic Shock 1.98 0.003 --- --- BTC or DT --- --- 3.00 0.01 Pulsatile pump --- --- 3.02 0.001 1 Hazard ratio denotes the increased risk with a 20 year increase in age 2 Hazard ratio denotes the increased risk with a 1.0 increase in INR 3 Hazard ratio denotes the increased risk of a 10-unit increase in RA pressure INTERMACS Annual Meeting March 2012

  32. INTERMACS: Survival after LVAD Implant Adult Primary Intracorporeal LVADs: n= 1366 Continuous Intracorporeal Pulsatile Intracorporeal “Average” Patient Predicted % Survival Risk Factor Unadjusted Adjusted Constant Phase Hazard ratio p-value Hazard ratio p-value Pulsatile pump 12.54 <0.0001 3.02 0.001 INTERMACS Annual Meeting March 2012 Months after Device Implant

  33. Risk Factors for Death after Implant Table 9 : June 2006 – March 2009 Primary LVAD: n=1092 Early Constant Risk Factor Hazard ratio p-value Hazard ratio p-value Age (older) 2.421 <.0001 1.551 .0005 Bilirubin (higher) 1.412 .0002 --- --- RA Pressure (higher) 2.083 .0009 --- --- Cardiogenic Shock 1.97 .02 --- --- BTC or DT --- --- 1.80 .02 Pulsatile pump --- --- 2.74 .001 1 Hazard ratio denotes the increased risk from age 60 to 70 years 2 Hazard ratio denotes the increased risk of a 2-unit increase in bilirubin 3 Hazard ratio denotes the increased risk of a 10-unit increase in RA pressure LVAD, left ventricular assist device; BTT, bridge to transplant; BTC, bridge to candidacy; DT, destination therapy; RA, right arterial INTERMACS Annual Meeting March 2012

  34. Research Topics in INTERMACS • Terminal Events and Risk Factors • What are the Next Steps? • Improving Patient Outcomes • Device Evaluation and Development INTERMACS Annual Meeting March 2012

  35. Research Topics in INTERMACS • Panel B: • Functional Capacity • Neurocognitive Assessment • Quality of Life • Terminal Events and Risk Factors • Panel Discussion Young INTERMACS Annual Meeting March 2012

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