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INTERMACS: June 2006 – December 2012: CMS Report Adults: n=7849 All primary implants as of 12/31/2012 n= 7928 Pediatric patients: n=79 (patients < 19 yrs.

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Presentation on theme: "INTERMACS: June 2006 – December 2012: CMS Report Adults: n=7849 All primary implants as of 12/31/2012 n= 7928 Pediatric patients: n=79 (patients < 19 yrs."— Presentation transcript:

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

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

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

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

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

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

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

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

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

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

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

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

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

14 Adult Primary Continuous Flow LVAD/BiVADs, n=6732 By Device Type Months post implant Event: Death (censored at transplant and recovery) % Survival CFLVADs n= 6549 Deaths=1406 INTERMACS: June 2006– December 2012: CMS Report CFBi-VADs, n= 182 Deaths=78 P <.0001 14 % Survival MonthsLVADBiVAD 196%77% 391%69% 687%65% 1281%59% 2470%54% Figure 14 INTERMACS 4/21/2013

15 Adult Primary Continuous Flow LVAD/BiVADs, n=6732 By Device Type Months post implant Event: Death (censored at transplant and recovery) % Survival CFLVADs n= 1875 Deaths=515 INTERMACS: June 2006– December 2012: CMS Report CFBi-VADs, n= 44 Deaths=28 P <.0001 15 % Survival MonthsLVADBiVAD 194%58% 388%51% 683%48% 1275%41% 2463%38% Age (yrs) ≥ 65 Figure 15 INTERMACS 4/21/2013

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

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


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