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INTERMACS 9th Annual Meeting May 15- 16, 2015 Quality of Life Session Presentations: • Quantifying the impact of adverse events on HRQOL early after implant • Patient selection and estimation of prognosis using health status measures • Predicting patients at risk for poor global outcomes after DT MCS therapy Improvement in Survival after LVAD Implant Actuarial survival for primary device implant, stratified by device type. Error bars indicate ± 1 SE. Patients are censored at transplant and recovery. CF, continuous flow; LVAD, left ventricular assist device; PF, pulsatile flow; TAH, total arti... Kirklin JK , Naftel DC, Pagani FD, et al., Sixth INTERMACS annual report: A 10,000-patient database. The Journal of Heart and Lung Transplantation, 2014;33(6):555 – 564. Improvement in Survival after LVAD Implant ↓ adverse events Actuarial survival for primary device implant, stratified by device type. Error bars indicate ± 1 SE. Patients are censored at transplant and recovery. CF, continuous flow; LVAD, left ventricular assist device; PF, pulsatile flow; TAH, total arti... Kirklin JK , Naftel DC, Pagani FD, et al., Sixth INTERMACS annual report: A 10,000-patient database. The Journal of Heart and Lung Transplantation, 2014;33(6):555 – 564. The Time is Right … to Assess Quality of Life after LVAD Implant Since 1948, when the World Health Organization defined health as being not only the absence of disease and infirmity, but also the presence of physical, mental, and social well-being, quality of life issues have become steadily more important in health care practice and research. Testa & Simonson, NEJM, 1996 What is the Clinical Importance of Measuring QOL? Clinical • Inform shared decision making • Diagnosis or screening • Monitoring patients in routine clinical care • Evaluating benefits and risks of treatment • Prognosis • Quality assessment / improvement Why Study QOL Outcomes? Research ● Determine the benefits of one treatment versus another regarding outcomes that are important to patients (e.g., HRQOL) ● Differentiate HRQOL benefits of two therapies with marginal differences in mortality or morbidity ● Estimate the burden of different diseases ● Compare impact of different diseases on functioning and well-being ● Inform relationships between QOL outcomes and clinical outcomes INTERMACS HRQOL Abstracts and Publications Abstracts (published): 7 abstracts Articles (published): Beyond survival: Recommendations from INTERMACS for Assessing Function and Quality of Life with Mechanical Circulatory Support Grady KL, Warner Stevenson L, Pagani FD, Teuteberg J, Pamboukian SV, Birks E, Moore S, Kirklin JK. J Heart Lung Transplant. 2012 Nov;31(11):1158-64. Overall Quality of Life Improves to Similar Levels after Mechanical Circulatory Support Regardless of Severity of Heart Failure before Implantation Grady KL, Naftel D, Stevenson L, Dew MA, Weidner G, Pagani FD, Kirklin JK, Myers S, Baldwin T, Young J. J Heart Lung Transplant. 2014 April;33 (4): 412-21. Change in Health-Related Quality of Life from Before to After Destination Therapy Mechanical Circulatory Support is Similar for Older and Younger Patients: Analyses from INTERMACS Grady KL, Naftel DC, Myers S, Dew MA, Weidner G, Spertus JA, Idrissi K, Lee HB, McGee EC, Kirklin JK. J Heart Lung Transplant. 2015 Feb;34(2):213-21. Articles (submitted): Age and gender differences in HRQOL and factors related to change in HRQOL from before to 6 months after LVAD implantation: Findings from INTERMACS Grady KL, Wissman S, Naftel D, Myers S, Gelijns A, Moskowitz A, Pagani F, Young J, Kirklin JK. J Heart Lung Transplant. INTERMACS HRQOL Data Capture across Time INTERMACS Pre-implant Data for June 2006 through March 2015 for Patients at Primary Implant EQ-5D Completion by Implant Year Implant Year Completed Not Completed Total 2006 26 (27%) 70 (73%) 96 2007 100 (30%) 237 (70%) 337 2008 301 (41%) 439 (59%) 740 2009 457 (45%) 553 (55%) 1010 2010 903 (55%) 747 (45%) 1650 2011 1025 (53%) 895 (47%) 1920 2012 1356 (59%) 937 (41%) 2293 2013 1553 (57%) 1190 (43%) 2743 2014 1465 (55%) 1204 (45%) 2669 2015 343 (59%) 238 (41%) 581 Total 7529 (54%) 6510 (46%) 14039 INTERMACS HRQOL Data Capture across Time INTERMACS Pre-implant Data for June 2006 through March 2015 for Patients at Primary Implant EQ-5D Completion (with non-completion reasons) by Implant Year Implant Year Completed Not completed reason other than too sick 2006 26 (27%) 21 (22%) 49 (51%) 96 2007 100 (30%) 79 (23%) 158 (47%) 337 2008 301 (41%) 208 (28%) 231 (31%) 740 2009 457 (45%) 304 (30%) 249 (25%) 1010 2010 903 (55%) 449 (27%) 298 (18%) 1650 2011 1025 (53%) 531 (28%) 364 (19%) 1920 2012 1356 (59%) 613 (27%) 324 (14%) 2293 2013 1553 (57%) 807 (29%) 383 (14%) 2743 2014 1465 (55%) 726 (27%) 478 (18%) 2669 2015 343 (59%) 141 (24%) 97 (17%) 581 Total 7529 (54%) 3879 (27%) 2631 (19%) 14039 Not completed – too sick Total Quantifying the Impact of Adverse Events on Health-Related Quality of Life Early after Implant Grady KL, Wissman S, Naftel D, Myers S, Gelijns A, Moskowitz A, Pagani F, Young J, Kirklin JK I will not discuss off label use and/or investigational use of drugs/devices. • Background – Risk factors for poor HRQOL after LVAD implant are unknown – Understanding risk factors • May inform selection criteria for device implant • Reinforce the ongoing need to improve device technology, in order to reduce rates of adverse events • Purpose – Identify pre and post implant factors related to change in overall HRQOL from before to 6 months after LVAD implantation – Rationale for 6month post implant time period • Patients are adjusting to “life on a device” while potentially dealing with early post implant adverse events METHODS Study Cohort, n=7353 (from 133 sites) Pool: Adult primary CFLVADs implanted Jun 2006 – Mar 2013 (follow-up thru March 2014) N=7353 6 month post implant patients, n=5931 patients with completed* 6 month EQ-5D VAS n=3353 (57%) Pre-implant patients, n=7353 Patients with completed* pre-implant EQ-5D VAS n=5640 (77%) Patients with both completed* pre-implant and 6 month post implant EQ-5D VAS n= 2748 (37% of total cohort) *completed includes patients who filled out the EQ-5D and also those patients captured as ‘too sick’. ‘Too sick’ patients were assigned 0 for the VAS and ‘extreme problems’ for the 3 physical dimensions of Mobility, Self Care and Usual Activities Study Cohort, n=7353 Pool: Adult primary CFLVADs implanted Jun 2006 – Mar 2013 (follow-up thru March 2014) N=7353 (133 sites) 6 month post implant patients, n=5931 patients with completed* 6 month EQ-5D VAS n=3353 (57%) Pre-implant patients, n=7353 Patients with completed* pre-implant EQ-5D VAS n=5640 (77%) Patients with both completed* pre-implant and 6 month post implant EQ-5D VAS n= 2748 (37% of total cohort) *completed includes patients who filled out the EQ-5D and also those patients captured as ‘too sick’. ‘Too sick’ patients were assigned 0 for the VAS and ‘extreme problems’ for the 3 physical dimensions of Mobility, Self Care and Usual Activities METHODS (cont.) Procedures • • • • Approval from all INTERMACS site IRBs Written consent from patients Patients completed a self-report HRQOL survey preimplant and post-implant at 3 and 6 months Medical records data collected per INTERMACS protocols HRQOL instrument • EQ – 5D – 3L Survey – – – – Generic, self-report health profile HRQOL items: 1 VAS scale (health status) and 5 questions If incomplete EQ-5D reason is “too sick”, VAS is assigned 0 Reliable and valid & norms in multiple populations Statistics • Pearson correlations and multiple regression analyses HRQOL Instrument Mobility EQ-5D-3L I have no problems in walking about q Health Questionnaire I have some problems in walking about q English version for the U.S. 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 RESULTS Characteristics of CF LVAD Patients Pre-implant LVAD with EQ-5D data (n=5640) Pre-implant LVAD w/out EQ-5D data (n=1713) p-value 56.7+12.86 57.1+13.01 0.22 Male (%) 78.6 80.8 0.05 Race (% white) 70.5 67.7 0.02 Married at implant (%) 66.9 65.3 0.22 >HS education (%) 53.4 48.6 0.004 1 15.3 10.8 < 0.0001 2 40.8 35.8 0.0002 3 27.2 26.4 0.55 4 12.4 18.9 <0.0001 5 2.3 4.8 <0.0001 6 1.3 2.0 0.04 7 1.2 0.7 0.04 Pre-implant Age at implant (mean yr+ SD) INTERMACS profile at implant (%) MCS Competing Outcomes Depiction & Rates of EQ-5D Completion after implant April 2008 – March 2013 100% 7.0% 6.0% 88% Proportion of Patients 10.0% 77% 4.0% 22.0% 60% 20.0% 7.0% 12.0% Alive (device 5.0% in place) 22% 54.0% 8% 4% 0% Pre-implant 52.0% 12% 11% 0% Txpl Dead 17% 1% Recovery Months Post Implant **completed forms includes patients who filled out the EQ-5D and also those patients captured as ‘too sick’ to complete the EQ-5D. ‘Too sick’ patients were assigned a value of 0 for the VAS and ‘extreme problems’ for the 3 physical dimensions of Mobility, Self Care and Usual Activities VAS Scores pre and post implant & change in VAS scores over time VAS 0 – 25 26 – 50 51 – 75 76 – 100 Total Pre-implant (n=5640**) 2714 (48.1%) 1589 (28.2%) 908 (16.1%) 429 (7.6%) 5640 (100%) Change in VAS (n=2748*) Increase >20 11 – 20 1 – 10 Decrease (or no change) 0 – 10 11 – 20 > 20 6 months (n=3353**) 404 (12.1%) 347 (10.3%) 974 (29.0%) 1628 (48.6%) 3353 (100%) n % 1637 254 274 59.6% 9.2% 10.0% 396 62 125 14.4% 2.3% 4.6% * Only includes paired data (patients with both pre and post 6 months completed EQ-5D) **completed forms includes patients who filled out the EQ-5D and also those patients captured as ‘too sick’ to complete the EQ-5D. ‘Too sick’ patients were assigned a value of 0 for the VAS. Factors Associated with Change in HRQOL Pre-implant – 6 months post implant Risk Factors Pre-implant conditions INTERMACS Level 1 BTT: Listed Pre COPD Alcohol abuse Pre-implant VAS Score Clinical Course BTT: Unlikely at 6 months BTT: Mod likely at 6 months NYHA 4 at 6 months Events within first 6 months Renal Dysfunction Respiratory Failure Neurological Dysfunction Infection Estimates (SE) 5.0 (1.6) -3.7 (1.2) -5.1 (1.8) -4.1 (1.7) -0.76 (0.02) p value 0.002 0.002 0.005 0.02 < 0.0001 -9.6 (2.9) -4.8 (1.9) -15.2 (2.9) 0.0009 0.01 < 0.0001 -5.3 (2.5) -4.8 (1.8) -5.5 (1.9) -2.8 (1.1) 0.03 0.007 0.004 0.01 Intercept = 64.2, R2 = 41.3%, n=2748 HRQOL=health-related quality of life; INTERMACS=interagency Registry for Mechanically Assisted Circulatory Support; BTT=bridge to transplant; COPD=chronic obstructive pulmonary disease; VAS=visual analog scale Negative coefficients indicate the decrement in change The Intercept indicates the amount of change (improvement) for a patient with no ‘risk factors’ Predictions of post implant VAS score by pre implant INTERMACS Profile Prediction of VAS at 6 months post implant, n=2748 Level 1 Pre-implant: Critical Cardiogenic Shock (n=337) Visual Analog Score (VAS) 100 90 Events during 1st 6 months 80 Renal 70.8 70 62.7 57.1 52.3 60 50 No Yes Yes Yes 40 30 20 10 12.8 Time Course 0 Pre implant Level 1 6 months post implant Respiratory Neuro No No No Yes No No Yes Yes Infection No Yes Yes Yes Predictions of post implant VAS score by pre implant INTERMACS Profile Prediction of VAS at 6 months post implant, n=2748 Level 2 Pre-implant: Progressive Decline (n=1119) Visual Analog Score (VAS) 100 90 Events during 1st 6 months 80 Renal 70 70.06 60 61.89 56.35 51.51 50 No Yes Yes Yes 40 30 31.35 20 Time Course 10 0 Pre implant Level 2 6 months post implant Respiratory Neuro No No No Yes No No Yes Yes Infection No Yes Yes Yes Predictions of post implant VAS score by pre implant INTERMACS Profile Prediction of VAS at 6 months post implant, n=2748 Level 3 Pre-implant: Stable but Inotrope Dependent (n=819) Visual Analog Score (VAS) 100 90 Events during 1st 6 months 80 Renal 70 72.09 60 63.92 58.38 53.54 50 40 No Yes Yes Yes 39.32 30 20 Time Course 10 0 Pre implant Level 3 6 months post implant Respiratory Neuro No No No Yes No No Yes Yes Infection No Yes Yes Yes Predictions of post implant VAS score by pre implant INTERMACS Profile Predictions of VAS at 6 months post implant, n=2748 Levels 4 - 7 Pre-implant (n=473) Visual Analog Score (VAS) 100 90 Events during 1st 6 months Renal 80 73.41 70 65.23 59.69 54.85 60 No Yes Yes Yes 50 40 43.51 30 20 Time Course 10 0 Pre implant Levels 4-7 6 months post implant Respiratory Neuro No No No Yes No No Yes Yes Infection No Yes Yes Yes CONCLUSIONS • Patients who are the sickest have the greatest opportunity for major improvement in HRQOL after implant • Patients with co-morbidities that prevent listing for HT may have limited HRQOL improvement • Adverse events have a detrimental impact on HRQOL at 6 months after implant IMPLICATIONS • These findings support the ongoing need to – evaluate co-morbid risks before implant – continue to improve device technology to enhance post implant HRQOL