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Predicting Major Outcomes after MCSD Implant 1 Risk Factors for Death, Transplant, and Recovery James Kirklin, MD David Naftel, PhD
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Predicting Major Outcomes after MCSD Implant 2 Two approaches: Simultaneous parametric modeling of the probabilities of the time related events based on a patient’s risk factors Simultaneous non-parametric estimation of the probabilities of the time related events based on sub-groups of patients
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Months post implant Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 n at risk: 9359 6195 4024 2736 1820 1194 711 408 174 3 Outcome Death Transplant Recovery Death Transplant Recovery Outcome/Month Instantaneous Rate (Hazard) of Outcomes
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Months post implant % Freedom from Transplantation % Free from Device Strategy n txplTXPL at 1 yr BTT Listed 2473 1188 56% BTT Likely 2140 801 67% BTT Mod Likely 958 178 83% BTT Unlikely 299 35 90% Destination Therapy 3370 190 95% Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 4 Event: Transplantation (censored at death or recovery) BTT Unlikely BTT Listed BTT Mod Likely BTT Likely Destination Therapy Device Strategy at Time of Implant
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Months post implant Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 n at risk: 9359 6195 4024 2736 1820 1194 711 408 174 5 Outcome Death Transplant Recovery Death Transplant Recovery Outcome/Month Instantaneous Rate (Hazard) of Outcomes
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INTERMACS
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Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 Device Strategy 1 2 3 4 5 6 7 BTT: Listed BTT: Likely BTT: Moderately BTT: Unlikely DT Continuous Flow LVAD I N T E R M A C S L E V E L S
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Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 Device Strategy 1 2 3 4 5 6 7 BTT: Listed BTT: Likely BTT: Moderately BTT: Unlikely DT Continuous Flow LVAD I N T E R M A C S L E V E L S
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Months after Implant Proportion of Patients Alive (device in place) 47% Transplanted 38% Dead 13% Recovery 1% Outcome % at 1 year 9 Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 CFLVAD BTT Listed LEVEL 1, n= 317
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Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 Device Strategy 1 2 3 4 5 6 7 BTT: Listed BTT: Likely BTT: Moderately BTT: Unlikely DT Continuous Flow LVAD I N T E R M A C S L E V E L S
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Months after Implant Proportion of Patients Alive (device in place) 63% Transplanted 4% Dead 31% Recovery 2% Outcome % at 1 year 11 Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 CFLVAD Destination Therapy LEVEL 1, n=344
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Months after Implant Proportion of Patients Alive (device in place) 70% Transplanted 3% Dead 26% Recovery 1% Outcome % at 1 year 12 Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 CFLVAD Destination Therapy LEVEL 2, n=1128
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Months after Implant Proportion of Patients Alive (device in place) 73% Transplanted 4% Dead 22% Recovery 1% Outcome % at 1 year 13 Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 CFLVAD Destination Therapy LEVEL 3, n=1081
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Months after Implant Proportion of Patients Alive (device in place) 76% Transplanted 3% Dead 21% Recovery 1% Outcome % at 1 year 14 Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 CFLVAD Destination Therapy LEVELS 4-7, n=749
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Months after Implant Proportion of Patients Alive (device in place) 46% Transplanted 40% Dead 13% Recovery 1% Outcome % at 1 year 15 Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 CFLVAD BTT Listed LEVEL 2, n=1084
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Months after Implant Proportion of Patients Alive (device in place) 51% Transplanted 39% Dead 9% Recovery 1% Outcome % at 1 year 16 Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 CFLVAD BTT Listed LEVEL 3, n= 604
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Months after Implant Proportion of Patients Alive (device in place) 45% Transplanted 42% Dead 12% Recovery 1% Outcome % at 1 year 17 Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 CFLVAD BTT Listed LEVELS 4-7, n=394
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Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 Competing Outcomes Analysis for Continuous Flow LVADs % at 1 year Alive nDeath TransplantRecovery (a device in place) Destination Therapy, n=3302 Level 1 34431%4%2%63% Level 2112826%3%1%70% Level 3108122%4%1%73% Levels 4-7 74921%3%1%76% BTT: Listed, n=2399 Level 1 31713%38%1%47% Level 2108413%40%1%46% Level 3 604 9%39%1%51% Levels 4-7 39412%42%1%45%
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Months after Implant Proportion of Patients Alive (device in place) 9% Transplanted 59% Dead 32% (Recovery 0%) Outcome % at 1 year 19 Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 TAH BTT Listed LEVEL 1, n=47
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Months after Implant Proportion of Patients Alive (device in place) 11% Transplanted 70% Dead 19% (Recovery 0%) Outcome % at 1 year 20 Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 TAH BTT Listed LEVEL 2, n=75
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Months post implant % Survival Deaths/months Hazard (early + late) n=9359, Deaths=2280 Months% Survival 195% 1280% 2469% 36 59% 4847% Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 n at risk: 9359 6195 4024 2736 1820 1194 711 408 174 21 Event: Death (censored at transplantation or recovery)
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% Freedom Months from TXPL 199% 1276% 2462% 36 56% 4852% Months post implant % Freedom from Transplantation Transplants/months Hazard (early + constant) n=9359, Transplants= 2422 Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 n at risk: 9359 6195 4024 2736 1820 1194 711 408 174 22 Event: Transplantation (censored at death or recovery)
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% Freedom Months from Recovery 1 100% 12 99% 24 98% 36 97% 48 96% Months post implant % Freedom from Recovery Recovery/months Hazard (constant) n=9360, Recovery= 89 Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 n at risk: 9359 6195 4024 2736 1820 1194 711 408 174 23 Event: Recovery (censored at death or transplantation)
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