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 flown=1117

CFLVADn=6550

CFBi-VADn=182

1Figure 1

INTERMACS: June 2006– December 2012: CMS Report

2Figure 2

2011-2012Total Implants: 5083Total Enrolled: 4592 (90.3%)

INTERMACS Hospitals

Adult Primary Continuous Flow LVAD/BiVADs, n=6732 By Age Groups

Months post implant

Event: Death (censored at transplant and recovery)

% S

urv

ival

Grp 1: < 50 yrs, n= 1758Deaths=293

INTERMACS: June 2006 – December 2012: CMS Report

Grp 2: 50–64 yrs, n= 3054Deaths=648

Grp 3: 65-69 yrs, n= 1030Deaths= 275

Overall p < .0001

3

Grp 4: 70+ yrs, n= 889Deaths= 268

Figure 3

Adult Primary Continuous Flow LVAD/BiVADs, n=6732 By Age Groups

Months post implant

Event: Death (censored at transplant and recovery)

% S

urv

ival

Grp 1: < 65 yrs, n= 4812Deaths=941

INTERMACS: June 2006 – December 2012: CMS Report

Grp 2: 65+ yrs, n= 1919Deaths=543

p < .0001

4Figure 4

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)

% S

urv

ival

Grp 1: 1-12 implants, n= 147Deaths=22

INTERMACS: June 2006 – December 2012: CMS Report

Grp 2: 13-32 implants, n= 1008Deaths=227

Grp 3: 33-56 implants, n= 2084Deaths= 456

Overall p = .17

5

Grp 4: 57-149 implants, n= 3486Deaths= 776

* Center volume is the total implants of FDA approved durable MCSDs implanted during 2011 and 2012

(14) (4)

Figure 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)

% S

urv

ival

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

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)

% S

urv

ival

Grp 1: 1-12 implants, n= 127Deaths=20

INTERMACS: March 2009 – December 2012: CMS Report

Grp 2: 13-32 implants, n= 946Deaths=214

Grp 3: 33-56 implants, n= 2084Deaths= 456

Overall p = .21

7

Grp 4: 57-149 implants, n= 3486Deaths= 776

DT Centers

* Center volume is the total implants of FDA approved durable MCSDs implanted during 2011 and 2012Figure 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)

% S

urv

ival

Grp 1: 1-12 implants, n= 83Deaths=12

INTERMACS: June 2006 – December 2012: CMS Report

Grp 2: 13-32 implants, n= 823Deaths=191

Grp 3: 33-56 implants, n= 2084Deaths= 456

Overall p = .14

8

Grp 4: 57-149 implants, n= 3486Deaths= 776

TX Centers

* Center volume is the total implants of FDA approved durable MCSDs implanted during 2011 and 2012Figure 8

Adult Primary Continuous Flow LVAD/BiVADs, n=6732 By DT Center

Months post implant

Event: Death (censored at transplant and recovery)

% S

urv

ival

Not a DT Center, n= 88Deaths=19

INTERMACS: June 2006 – December 2012: CMS Report

DT Center, n= 6643Deaths=1466

Overall p = .54

9Figure 9

Adult Primary Continuous Flow LVAD/BiVADs, n=6732 By TX Center

Months post implant

Event: Death (censored at transplant and recovery)

% S

urv

ival

Not a TX Center, n= 255Deaths=49

INTERMACS: June 2006 – December 2012: CMS Report

TX Center, n= 6476Deaths=1435

Overall p = .52

10Figure 10

Adult Primary Continuous Flow LVAD/BiVADs, n=6732 By DT and/or TX Center

Months post implant

Event: Death (censored at transplant and recovery)

% S

urv

ival

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 = .53Grp 1 v 2: p=.40Grp 1 v 3: p=.22Grp 1 v 4: p=.81Grp 2 v 3: p=.62Grp 2 v 4: p=.64Grp 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

Adult Primary Continuous Flow LVAD/BiVADs, n=6732 By Device Strategy

Months post implant

Event: Death (censored at transplant and recovery)

% S

urv

ival

Grp 1: BTT, n= 1875Deaths=317

INTERMACS: June 2006– December 2012: CMS Report

Grp 2: BTC, n= 2517Deaths=540

Grp 3: DT, n= 2250Deaths= 606

Overall p = .14

12

Grp 4: Other*, n= 89Deaths= 21

*For overall “Other” Device strategies at time of implant include 40 bridge to recoveries, 21 Rescue therapy and 28 Others

Figure 12

Adult Primary Continuous Flow LVAD/BiVADs, n=6732 By Device Strategy

Months post implant

Event: Death (censored at transplant and recovery)

% S

urv

ival

Grp 1: BTT, n= 276Deaths=62

INTERMACS: June 2006– December 2012: CMS Report

Grp 2: BTC, n= 399Deaths=116

Grp 3: DT, n= 1232Deaths=361

Overall p = .24

13

Grp 4: Other*, n= 12Deaths= 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

Adult Primary Continuous Flow LVAD/BiVADs, n=6732 By Device Type

Months post implant

Event: Death (censored at transplant and recovery)

% S

urv

ival

CFLVADs n= 6549Deaths=1406

INTERMACS: June 2006– December 2012: CMS Report

CFBi-VADs, n= 182Deaths=78

P < .0001

14

% SurvivalMonths LVAD BiVAD1 96% 77%3 91% 69%6 87% 65%12 81% 59%24 70% 54%

Figure 14

Adult Primary Continuous Flow LVAD/BiVADs, n=6732 By Device Type

Months post implant

Event: Death (censored at transplant and recovery)

% S

urv

ival

CFLVADs n= 1875Deaths=515

INTERMACS: June 2006– December 2012: CMS Report

CFBi-VADs, n= 44Deaths=28 P < .0001

15

% SurvivalMonths LVAD BiVAD1 94% 58%3 88% 51%6 83% 48%12 75% 41%24 63% 38%

Age (yrs) ≥ 65

Figure 15

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 Months post implant

Pro

port

ion

of p

atie

nts

Pro

port

ion

of p

atie

nts

Figure 16

(a) (b)

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 Months post implant

Pro

port

ion

of p

atie

nts

Pro

port

ion

of p

atie

nts

Figure 17

(a) (b)