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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. I have no financial disclosures (I am the Principle Investigator for the NIH contract for INTERMACS). James K Kirklin.

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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. I have no financial disclosures (I am the Principle Investigator for the NIH contract for INTERMACS) James K Kirklin

  3. Predicting Major Outcomes after MCSD Implant Risk Factors for Death, Transplant, and Recovery What do we have so far?

  4. 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

  5. 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

  6. Implants: June 2006 – December 2013, n=10542 LVAD: Continuous n=9112, Deaths=2154 % Survival at Pump 1 yr post implant CF LVAD 81% CF Bi-VAD 57% PF LVAD 65% PF Bi-VAD 45% TAH 59% TAH: Pulsatile n=239, Deaths=59 % Survival BiVAD: Continuous n=260, Deaths=118 LVAD: Pulsatile n=612, Deaths=230 BiVAD: Pulsatile n=319, Deaths=123 overall p < .0001 Event: Death (censored at transplant and recovery) Months post implant Figure 10

  7. Implants: June 2006 – December 2013, n=10542 % Survival at Pump 1 yr post implant CF LVAD 81% CF Bi-VAD 57% PF LVAD 65% PF Bi-VAD 45% TAH 59% LVAD: Continuous n=9112, Deaths=2154 TAH: Pulsatile n=239, Deaths=59 % Survival BiVAD: Continuous n=260, Deaths=118 LVAD: Pulsatile n=612, Deaths=230 BiVAD: Pulsatile n=319, Deaths=123 overall p < .0001 Event: Death (censored at transplant and recovery) Months post implant

  8. Adult Primary Continuous Flow LVADs and BiVADs Implants: June 2006 – December 2013, n=9372

  9. Adult Primary Continuous Flow LVADs and BiVADs Implants: June 2006 – December 2013, n=9372

  10. Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9372 Age < 50 yrs n=2403, deaths=446 Age > 70 yrs, n=1301 deaths=451 Age 50-64 yrs n=4184 Deaths= 942 % Survival Age 65-70 yrs n=1484, deaths=433 Overall P < .0001 Event: Death (censored at transplant and recovery) Months post implant

  11. June 2006 – December 2012 INTERMACS

  12. Adult Primary Continuous Flow LVADs and BiVADs Implants: June 2006 – December 2013, n=9372

  13. Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9372 Levels 4-7, n=1789 Deaths=405 Level 1: n=1391 Deaths=381 Level 3: n=2591 Deaths=544 % Survival Level 2: n=3601 Deaths=942 P < .0001 Event: Death (censored at transplant and recovery) Months post implant

  14. Continuous Flow Devices CF-LVAD/BiVAD Implants: January 2008 – December 2013, n=9372

  15. Continuous Flow Devices CF-LVAD/BiVAD Implants: January 2008 – December 2013, n=9372

  16. Adult Primary Continuous Flow LVADs and BiVADs Implants: June 2006 – December 2013, n=9372 LVAD, left ventricular assist device; BiVAD, biventricular assist device; DT, destination therapy; BTT, bridge to transplant; BMI, body mass index; BUN, blood urea nitrogen; RVAD, right ventricular assist device. Table 6

  17. Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9372 BTR, n= 46 Deaths= 4 BTT (including BTC), n= 5886 Deaths= 1218 % Survival Rescue Therapy, n= 27 Deaths= 11 DT, n= 3373 Deaths= 1027 Other, n= 40 Deaths= 12 p < .0001 Event: Death (censored at transplant and recovery) Months post implant

  18. Continuous Flow Devices CF-LVAD/BiVAD Implants: June 2006 – December 2013, n=9372

  19. Adult Primary Continuous Flow LVADs and BiVADs Implants: June 2006 – December 2013, n=9372 LVAD, left ventricular assist device; BiVAD, biventricular assist device; DT, destination therapy; BTT, bridge to transplant; BMI, body mass index; BUN, blood urea nitrogen; RVAD, right ventricular assist device. Table 6

  20. Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9372 Survival by Renal Risk Factors Low n=8237, deaths=1862 % Survival Moderate (creat > 2 or BUN > 60) n=993, deaths=339 Severe (dialysis) n=142, deaths=71 Overall P < .0001 Event: Death (censored at transplant and recovery) Months post implant Figure 14

  21. Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9372 Survival by Renal Risk Factors Low n=8237, deaths=1862 % Survival Moderate (creat > 2 or BUN > 60) n=993, deaths=339 Severe (dialysis) n=142, deaths=71 Overall P < .0001 Event: Death (censored at transplant and recovery) Months post implant Figure 14

  22. Adult Primary Continuous Flow LVADs & BIVADs, DT and BTT , n=4917 Implants: June 2006 – March 2012: Creatinine Adult Primary Continuous Flow LVADs & BIVADs, DT and BTT , n=4917 Implants: June 2006 – March 2012: Time course of Creatinine according to pre-implant Renal Dysfunction Severe (n=282) ** ** ** ** ** ** Creatinine (mg/dL) ** Moderate (n=1475) ** ** ** ** ** ** ** * ** ** ** Mild/None (n=3160) ** Follow-up Time Period • * p < .05 • ** p < .001 • Paired comparisons to pre-implant

  23. Adult Primary Continuous Flow LVADs and BiVADs Implants: June 2006 – December 2013, n=9372

  24. Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9372 Survival by Right Heart Failure Risk Factors Low n=6596, deaths=1481 Moderate (ascites or RAP >= 18 or Bilirubin >= 2) n=2516, deaths=690 Severe (BiVAD) n=260, deaths=120 % Survival Overall P < .0001 Event: Death (censored at transplant and recovery) Months post implant

  25. Adult Primary Continuous Flow LVADs and BiVADs Implants: June 2006 – December 2013, n=9372

  26. 04/04/2014 Tricuspid Repair Following VAD Implantation in INTERMACS Howard Song, MD, PhD Co-authors James Mudd, MD; Jill Gelow, MD, MPH; Christopher Chien, MD; Fred Tibayan, MD; Kathryn Hollifield, BSN, RN; David Naftel, PhD; and James Kirklin, MD "This project has been funded in whole or in part with Federal funds from the National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN268201100025C"

  27. INTERMACS: June 2006 – March 2013: TVR Adult Destination Therapy CF primary LVAD/BiVAD, n=2527 Phase of Hazard Early Constant Risk Factors for Death Hazard ratio p-value Hazard ratio p-value Age (years) 1.58 < .0001 BMI (higher) 1.49 .0003 Not Married 1.93 .0009 Hx of CABG 1.56 .02 BUN (higher) 1.10 .006 1.06 .01 Total Bilirubin (higher) 1.78 .02 Creatinine (higher) 1.10 .001 Ventilator 2.18 .005 INTERMACS Level 1 2.74 .0001 INTERMACS Level 2 1.85 .004 Bi-VAD 5.05 < .0001 Tricuspid Regurgitation 1.35* .009 * Represents the increased risk for 1 level increase in TV Regurgitation

  28. So, is the real risk factor the procedure or the condition?

  29. INTERMACS: June 2006 – March 2013: TVR Adult Destination Therapy CF primary LVAD/BiVAD, n=2527 Tricuspid Regurg Echo at pre-implant: Moderate/Severe , n=989 Concomitant Tricuspid Surgery n deaths None 757 225 Repair 215 60 Overall p = .83 % Survival Event: Death with a device in place (censored at transplant and recovery Months post implant

  30. INTERMACS: June 2006 – March 2013: TVR n=757 No TV Procedure, n=757 TV Repair, n= 215 n=215 Moderate/Severe Tricuspid Regurgitation over time by TV Repair vs. No TVR Procedure, n=989 % Moderate/Severe Tricuspid Regurgitation n=12 n=136 n=31 n=75 n=46 n=88 n=50 n=3 n=17 n=17 n=8 n=9 n=21 n=3 Note: N’s represent the number of Moderate/Severe Tricuspid Regurg

  31. Continuous Flow LVAD Implants: 2008 – 2013, n=9111 Pump Thrombosis Era 1: 2008-2010 n=2800, Events=273 Era 2: 2011-2013 N=6311, events=522 p < .0001 % Freedom from Exchange Event: Time to 1st Exchange Months post implant

  32. Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9372 Operation 1: N=8565, deaths=2039 p < .0001 Operation 2: n=734, Deaths=242 % Survival Operation 3: n=73, Deaths=29 Event: Death (censored at transplant and recovery) Months post implant Figure 20

  33. Education Cardiac Surgery War Era These stratified actuarial depictions are very useful, but… • They have limited value for predicting outcomes for an individual patient. • The stratified actuarial method forces conditions like ..”assuming he/she does not receive a heart transplant”, or ..”assuming there is not explant for recovery” • Ideally, INTERMACS could provide software or website applications that allow the physician to provide the patient with the most useful predictions of the chances of various outcomes occurring to him/her.

  34. Education Cardiac Surgery War Era Predictive modeling for outcome events based on initial implant strategy • The goal is useful predictions of the likelihood (probability) of a specific patient (with his/her individual risk profile) experiencing a given outcome depending on the initial implant strategy. • The basic methodology utilizes multivariable hazard function analyses on the competing outcomes platform. • The basic strategies are BTT, BTC, DT, and BTR. • The outcome event of interest are Transplant, Alive on device, Explant for recovery, and death. • David Naftel will review our initial steps in this process.

  35. Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9372 BTT: Listed CFLVAD implants 2011-2013, n=1309 Outcome % at 1 year Alive (device in place) 50% Transplanted 37% Dead 12% Recovery 1% Proportion of Patients Months after Implant Figure 6

  36. Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9372 BTC CFLVAD implants 2011-2013, n=2205 Outcome % at 1 year Alive (device in place) 64% Transplanted 20% Dead 15% Recovery 1% Proportion of Patients Months after Implant Figure 7

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