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Predicting Major Outcomes after MCSD Implant

Predicting Major Outcomes after MCSD Implant. Risk Factors for Death, Transplant, and Recovery James Kirklin, MD David Naftel, PhD. Predicting Major Outcomes after MCSD Implant. Two approaches:

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Predicting Major Outcomes after MCSD Implant

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  1. Predicting Major Outcomes after MCSD Implant • Risk Factors for Death, Transplant, and Recovery • James Kirklin, MD • David Naftel, PhD

  2. Predicting Major Outcomes after MCSD Implant • 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

  3. Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 Instantaneous Rate (Hazard) of Outcomes Outcome Death Transplant Recovery Outcome/Month Death Transplant Recovery n at risk: 9359 6195 4024 2736 1820 1194 711 408 174 Months post implant

  4. Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 Event: Transplantation (censored at death or recovery) Device Strategy at Time of Implant Destination Therapy BTT Unlikely BTT Mod Likely % Freedom from Transplantation BTT Likely % Free from Device Strategy n txpl TXPL 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% BTT Listed Months post implant

  5. Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 Instantaneous Rate (Hazard) of Outcomes Outcome Death Transplant Recovery Outcome/Month Death Transplant Recovery n at risk: 9359 6195 4024 2736 1820 1194 711 408 174 Months post implant

  6. INTERMACS

  7. Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 Continuous Flow LVAD I N T E R M A C S L E V E L S Device Strategy 1 2 3 4 5 6 7 BTT: Listed BTT: Likely BTT: Moderately BTT: Unlikely DT

  8. Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 Continuous Flow LVAD I N T E R M A C S L E V E L S Device Strategy 1 2 3 4 5 6 7 BTT: Listed BTT: Likely BTT: Moderately BTT: Unlikely DT

  9. Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 CFLVAD BTT Listed LEVEL 1, n= 317 Outcome % at 1 year Alive (device in place) 47% Transplanted 38% Dead 13% Recovery 1% Proportion of Patients Months after Implant

  10. Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 Continuous Flow LVAD I N T E R M A C S L E V E L S Device Strategy 1 2 3 4 5 6 7 BTT: Listed BTT: Likely BTT: Moderately BTT: Unlikely DT

  11. Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 CFLVAD Destination Therapy LEVEL 1, n=344 Outcome % at 1 year Alive (device in place) 63% Transplanted 4% Dead 31% Recovery 2% Proportion of Patients Months after Implant

  12. Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 CFLVAD Destination Therapy LEVEL 2, n=1128 Outcome % at 1 year Alive (device in place) 70% Transplanted 3% Dead 26% Recovery 1% Proportion of Patients Months after Implant

  13. Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 CFLVAD Destination Therapy LEVEL 3, n=1081 Outcome % at 1 year Alive (device in place) 73% Transplanted 4% Dead 22% Recovery 1% Proportion of Patients Months after Implant

  14. Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 CFLVAD Destination Therapy LEVELS 4-7, n=749 Outcome % at 1 year Alive (device in place) 76% Transplanted 3% Dead 21% Recovery 1% Proportion of Patients Months after Implant

  15. Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 CFLVAD BTT Listed LEVEL 2, n=1084 Outcome % at 1 year Alive (device in place) 46% Transplanted 40% Dead 13% Recovery 1% Proportion of Patients Months after Implant

  16. Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 CFLVAD BTT Listed LEVEL 3, n= 604 Outcome % at 1 year Alive (device in place) 51% Transplanted 39% Dead 9% Recovery 1% Proportion of Patients Months after Implant

  17. Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 CFLVAD BTT Listed LEVELS 4-7, n=394 Outcome % at 1 year Alive (device in place) 45% Transplanted 42% Dead 12% Recovery 1% Proportion of Patients Months after Implant

  18. Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 Competing Outcomes Analysis for Continuous Flow LVADs % at 1 year Alive n Death Transplant Recovery (a device in place) Destination Therapy, n=3302 Level 1 344 31% 4% 2% 63% Level 2 1128 26% 3% 1% 70% Level 3 1081 22% 4% 1% 73% Levels 4-7 749 21% 3% 1% 76% BTT: Listed, n=2399 Level 1 317 13% 38% 1% 47% Level 2 1084 13% 40% 1% 46% Level 3 604 9% 39% 1% 51% Levels 4-7 394 12% 42% 1% 45%

  19. Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 TAH BTT Listed LEVEL 1, n=47 Outcome % at 1 year Alive (device in place) 9% Transplanted 59% Dead 32% (Recovery 0%) Proportion of Patients Months after Implant

  20. Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 TAH BTT Listed LEVEL 2, n=75 Outcome % at 1 year Alive (device in place) 11% Transplanted 70% Dead 19% (Recovery 0%) Proportion of Patients Months after Implant

  21. Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 Event: Death (censored at transplantation or recovery) n=9359, Deaths=2280 • Months % Survival • 1 95% • 12 80% • 24 69% • 59% • 48 47% % Survival Deaths/months Hazard (early + late) n at risk: 9359 6195 4024 2736 1820 1194 711 408 174 Months post implant

  22. Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 Event: Transplantation (censored at death or recovery) n=9359, Transplants= 2422 • % Freedom • Months from TXPL • 1 99% • 12 76% • 24 62% • 56% • 48 52% % Freedom from Transplantation Transplants/months Hazard (early + constant) n at risk: 9359 6195 4024 2736 1820 1194 711 408 174 Months post implant

  23. Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 Event: Recovery (censored at death or transplantation) n=9360, Recovery= 89 • % Freedom • Months from Recovery • 1 100% • 12 99% • 24 98% • 97% • 48 96% % Freedom from Recovery Recovery/months Hazard (constant) n at risk: 9359 6195 4024 2736 1820 1194 711 408 174 Months post implant

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