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INTERMACS: June 2006 – December 2012: CMS Report

INTERMACS: June 2006 – December 2012: CMS Report. All primary implants as of 12/31/2012 n= 7928. INTERMACS 4/21/2013. Pediatric patients: n=79 (patients < 19 yrs of age at time of implant). Adults: n=7849. Pulsatile flow n=1117. Continuous Flow n=6732. CFBi-VAD n=182. CFLVAD

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INTERMACS: June 2006 – December 2012: CMS Report

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  1. INTERMACS: June 2006 – December 2012: CMS Report All primary implants as of 12/31/2012 n= 7928 INTERMACS 4/21/2013 Pediatric patients: n=79 (patients < 19 yrs of age at time of implant) Adults: n=7849 Pulsatile flow n=1117 Continuous Flow n=6732 CFBi-VAD n=182 CFLVAD n=6550 Figure 1

  2. INTERMACS: June 2006– December 2012: CMS Report 2011-2012 Total Implants: 5083 Total Enrolled: 4592 (90.3%) INTERMACS 4/21/2013 INTERMACS Hospitals Figure 2

  3. INTERMACS: June 2006 – December 2012: CMS Report Adult Primary Continuous Flow LVAD/BiVADs, n=6732 By Age Groups Grp 1: < 50 yrs, n= 1758 Deaths=293 Grp 2: 50–64 yrs, n= 3054 Deaths=648 INTERMACS 4/21/2013 Grp 3: 65-69 yrs, n= 1030 Deaths= 275 % Survival Grp 4: 70+ yrs, n= 889 Deaths= 268 Overall p < .0001 Event: Death (censored at transplant and recovery) Months post implant Figure 3

  4. INTERMACS: June 2006 – December 2012: CMS Report Adult Primary Continuous Flow LVAD/BiVADs, n=6732 By Age Groups Grp 1: < 65 yrs, n= 4812 Deaths=941 INTERMACS 4/21/2013 Grp 2: 65+ yrs, n= 1919 Deaths=543 % Survival p < .0001 Event: Death (censored at transplant and recovery) Months post implant Figure 4

  5. INTERMACS: June 2006 – December 2012: CMS Report Adult Primary Continuous Flow LVAD/BiVADs, n=6732 By Total Center Volume* for 2011 and 2012 Grp 1: 1-12 implants, n= 147 Deaths=22 (14) (4) INTERMACS 4/21/2013 Grp 2: 13-32 implants, n= 1008 Deaths=227 % Survival Grp 3: 33-56 implants, n= 2084 Deaths= 456 Grp 4: 57-149 implants, n= 3486 Deaths= 776 Overall p = .17 Event: Death (censored at transplant and recovery) Months post implant * Center volume is the total implants of FDA approved durable MCSDs implanted during 2011 and 2012 Figure 5

  6. INTERMACS: June 2006 – December 2012: CMS Report Adult Primary Continuous Flow LVAD/BiVADs, n=6732 By Total Center Volume* for 2011 and 2012 Age (yrs) ≥ 65 INTERMACS 4/21/2013 % Survival Grp 1: 1-12 implants, n= 62, Deaths=17 Grp 2: 13-32 implants, n=290, Deaths=83 Grp 3: 33-56 implants, n=528, Deaths=154 Grp 4: 57-149 implants, n=1038, Deaths=288 Overall p = .54 Event: Death (censored at transplant and recovery) Months post implant * Center volume is the total implants of FDA approved durable MCSDs implanted during 2011 and 2012 Figure 6

  7. INTERMACS: March 2009 – December 2012: CMS Report Adult Primary Continuous Flow LVAD/BiVADs, n=6732 By Total Center Volume* for 2011 and 2012 DT Centers Grp 1: 1-12 implants, n= 127 Deaths=20 INTERMACS 4/21/2013 Grp 2: 13-32 implants, n= 946 Deaths=214 % Survival Grp 3: 33-56 implants, n= 2084 Deaths= 456 Grp 4: 57-149 implants, n= 3486 Deaths= 776 Overall p = .21 Event: Death (censored at transplant and recovery) Months post implant * Center volume is the total implants of FDA approved durable MCSDs implanted during 2011 and 2012 Figure 7

  8. INTERMACS: June 2006 – December 2012: CMS Report Adult Primary Continuous Flow LVAD/BiVADs, n=6732 By Total Center Volume* for 2011 and 2012 TX Centers Grp 1: 1-12 implants, n= 83 Deaths=12 INTERMACS 4/21/2013 Grp 2: 13-32 implants, n= 823 Deaths=191 % Survival Grp 3: 33-56 implants, n= 2084 Deaths= 456 Grp 4: 57-149 implants, n= 3486 Deaths= 776 Overall p = .14 Event: Death (censored at transplant and recovery) Months post implant * Center volume is the total implants of FDA approved durable MCSDs implanted during 2011 and 2012 Figure 8

  9. INTERMACS: June 2006 – December 2012: CMS Report Adult Primary Continuous Flow LVAD/BiVADs, n=6732 By DT Center DT Center, n= 6643 Deaths=1466 INTERMACS 4/21/2013 Not a DT Center, n= 88 Deaths=19 % Survival Overall p = .54 Event: Death (censored at transplant and recovery) Months post implant Figure 9

  10. INTERMACS: June 2006 – December 2012: CMS Report Adult Primary Continuous Flow LVAD/BiVADs, n=6732 By TX Center TX Center, n= 6476 Deaths=1435 INTERMACS 4/21/2013 Not a TX Center, n= 255 Deaths=49 % Survival Overall p = .52 Event: Death (censored at transplant and recovery) Months post implant Figure 10

  11. INTERMACS: June 2006 – December 2012: CMS Report Adult Primary Continuous Flow LVAD/BiVADs, n=6732 By DT and/or TX Center Grp 1: DT and TX Center, n=6435, deaths=1425 Grp 2: DT Center (not TX Ctr), n=208, deaths=41 INTERMACS 4/21/2013 Grp 4: Not DT Ctr, Not TX Ctr, n=47, deaths=8 Grp 3: TX Center (not DT Ctr), n=41, deaths=10 % Survival Overall p = .53 Grp 1 v 2: p=.40 Grp 1 v 3: p=.22 Grp 1 v 4: p=.81 Grp 2 v 3: p=.62 Grp 2 v 4: p=.64 Grp 3 v 4: p=.48 Event: Death (censored at transplant and recovery) Months post implant Figure 11

  12. INTERMACS: June 2006– December 2012: CMS Report Adult Primary Continuous Flow LVAD/BiVADs, n=6732 By Device Strategy Grp 1: BTT, n= 1875 Deaths=317 Grp 2: BTC, n= 2517 Deaths=540 INTERMACS 4/21/2013 Grp 3: DT, n= 2250 Deaths= 606 % Survival Grp 4: Other*, n= 89 Deaths= 21 Overall p = .14 Event: Death (censored at transplant and recovery) Months post implant *For overall “Other” Device strategies at time of implant include 40 bridge to recoveries, 21 Rescue therapy and 28 Others Figure 12

  13. INTERMACS: June 2006– December 2012: CMS Report Adult Primary Continuous Flow LVAD/BiVADs, n=6732 By Device Strategy Age (yrs) ≥ 65 Grp 1: BTT, n= 276 Deaths=62 Grp 2: BTC, n= 399 Deaths=116 INTERMACS 4/21/2013 Grp 3: DT, n= 1232 Deaths=361 % Survival Grp 4: Other*, n= 12 Deaths= 4 Overall p = .24 Event: Death (censored at transplant and recovery) Months post implant *For overall “Other” Device strategies at time of implant include 40 bridge to recoveries, 21 Rescue therapy and 28 Others Figure 13

  14. INTERMACS: June 2006– December 2012: CMS Report Adult Primary Continuous Flow LVAD/BiVADs, n=6732 By Device Type CFLVADs n= 6549 Deaths=1406 INTERMACS 4/21/2013 % Survival % Survival Months LVAD BiVAD 1 96% 77% 3 91% 69% 6 87% 65% 12 81% 59% 24 70% 54% CFBi-VADs, n= 182 Deaths=78 P < .0001 Event: Death (censored at transplant and recovery) Months post implant Figure 14

  15. INTERMACS: June 2006– December 2012: CMS Report Adult Primary Continuous Flow LVAD/BiVADs, n=6732 By Device Type Age (yrs) ≥ 65 % Survival Months LVAD BiVAD 1 94% 58% 3 88% 51% 6 83% 48% 12 75% 41% 24 63% 38% CFLVADs n= 1875 Deaths=515 INTERMACS 4/21/2013 CFBi-VADs, n= 44 Deaths=28 P < .0001 % Survival Event: Death (censored at transplant and recovery) Months post implant Figure 15

  16. INTERMACS: June 2006– December 2012: CMS Report Adult Primary Continuous Flow LVAD/BiVADs, n=6732 Age (yrs) < 65 (n=4813) Age (yrs) ≥ 65 (n=1919) INTERMACS 4/21/2013 Dead 50% Transplanted Proportion of patients Proportion of patients 39% Alive (device in place) 34% Dead 38% Transplanted 16% 22% Alive (device in place) Recovery 1% Recovery 0.4% Months post implant Months post implant (a) (b) Figure 16

  17. INTERMACS: June 2006– December 2012: CMS Report Adult Primary Continuous Flow LVAD/BiVADs, n=6732 DT Centers (n=6643) Not DT Center (n=88) INTERMACS 4/21/2013 Dead Proportion of patients Proportion of patients 42% Transplanted 42% Dead 32% 35% Transplanted 25% Alive (device in place) 21% Alive (device in place) Recovery 1% Recovery 2% Months post implant Months post implant (a) (b) Figure 17

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