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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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slide1

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

slide2

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

slide3

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

slide4

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

slide5

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

slide6

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

slide7

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

slide8

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

slide9

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

slide10

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

slide11

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

slide12

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

slide13

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

slide14

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

slide15

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

slide16

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

slide17

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