Predicting Major Outcomes after MCSD Implant

1

Risk Factors for Death, Transplant, and Recovery

James Kirklin, MDDavid Naftel, PhD

Predicting Major Outcomes after MCSD Implant

2

Two approaches:

•Simultaneous parametric modeling of the probabilities of the time related events based on a patient’s risk factors

•Simultaneous non-parametric estimation of the probabilities of the time related events based on sub-groups of patients

Months post implant

Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359

n at risk: 9359 6195 4024 2736 1820 1194 711 408 174

3

OutcomeDeathTransplantRecovery

Death

TransplantRecovery

Out

com

e/M

onth

Instantaneous Rate (Hazard) of Outcomes

Months post implant

% F

reed

om fr

om T

rans

plan

tatio

n

% Free from Device Strategy n txpl TXPL at 1 yrBTT Listed 2473 1188 56%BTT Likely 2140 801 67%BTT Mod Likely 958 178 83%BTT Unlikely 299 35 90%Destination Therapy 3370 190 95%

Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359

4

Event: Transplantation (censored at death or recovery)

BTT Unlikely

BTT Listed

BTT Mod Likely

BTT Likely

Destination Therapy

Device Strategy at Time of Implant

Months post implant

Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359

n at risk: 9359 6195 4024 2736 1820 1194 711 408 174

5

OutcomeDeathTransplantRecovery

Death

TransplantRecovery

Out

com

e/M

onth

Instantaneous Rate (Hazard) of Outcomes

Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359

Device Strategy 1 2 3 4 5 6 7

BTT: Listed

BTT: Likely

BTT: Moderately

BTT: Unlikely

DT

Continuous Flow LVADI N T E R M A C S L E V E L S

Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359

Device Strategy 1 2 3 4 5 6 7

BTT: Listed

BTT: Likely

BTT: Moderately

BTT: Unlikely

DT

Continuous Flow LVADI N T E R M A C S L E V E L S

Months after Implant

Pro

po

rtio

n o

f P

ati

ents

Alive (device in place) 47%Transplanted 38%Dead 13%Recovery 1%

Outcome % at 1 year

9

Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359

CFLVAD BTT Listed LEVEL 1, n= 317

Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359

Device Strategy 1 2 3 4 5 6 7

BTT: Listed

BTT: Likely

BTT: Moderately

BTT: Unlikely

DT

Continuous Flow LVADI N T E R M A C S L E V E L S

Months after Implant

Pro

po

rtio

n o

f P

ati

ents

Alive (device in place) 63%Transplanted 4%Dead 31%Recovery 2%

Outcome % at 1 year

11

Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359

CFLVAD Destination Therapy LEVEL 1, n=344

Months after Implant

Pro

po

rtio

n o

f P

ati

ents

Alive (device in place) 70%Transplanted 3%Dead 26%Recovery 1%

Outcome % at 1 year

12

Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359

CFLVAD Destination Therapy LEVEL 2, n=1128

Months after Implant

Pro

po

rtio

n o

f P

ati

ents

Alive (device in place) 73%Transplanted 4%Dead 22%Recovery 1%

Outcome % at 1 year

13

Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359

CFLVAD Destination Therapy LEVEL 3, n=1081

Months after Implant

Pro

po

rtio

n o

f P

ati

ents

Alive (device in place) 76%Transplanted 3%Dead 21%Recovery 1%

Outcome % at 1 year

14

Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359

CFLVAD Destination Therapy LEVELS 4-7, n=749

Months after Implant

Pro

po

rtio

n o

f P

ati

ents

Alive (device in place) 46%Transplanted 40%Dead 13%Recovery 1%

Outcome % at 1 year

15

Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359

CFLVAD BTT Listed LEVEL 2, n=1084

Months after Implant

Pro

po

rtio

n o

f P

ati

ents

Alive (device in place) 51%Transplanted 39%Dead 9%Recovery 1%

Outcome % at 1 year

16

Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359

CFLVAD BTT Listed LEVEL 3, n= 604

Months after Implant

Pro

po

rtio

n o

f P

ati

ents

Alive (device in place) 45%Transplanted 42%Dead 12%Recovery 1%

Outcome % at 1 year

17

Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359

CFLVAD BTT Listed LEVELS 4-7, n=394

Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359

Competing Outcomes Analysis for Continuous Flow LVADs

% at 1 year Alive n Death Transplant Recovery (a device in place)

Destination Therapy, n=3302Level 1 344 31% 4% 2% 63%Level 2 1128 26% 3% 1% 70%Level 3 1081 22% 4% 1% 73%Levels 4-7 749 21% 3% 1% 76%

BTT: Listed, n=2399Level 1 317 13% 38% 1% 47%Level 2 1084 13% 40% 1% 46%Level 3 604 9% 39% 1% 51%Levels 4-7 394 12% 42% 1% 45%

Months after Implant

Pro

po

rtio

n o

f P

ati

ents

Alive (device in place) 9%Transplanted 59%Dead 32%(Recovery 0%)

Outcome % at 1 year

19

Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359

TAH BTT Listed LEVEL 1, n=47

Months after Implant

Pro

po

rtio

n o

f P

ati

ents

Alive (device in place) 11%Transplanted 70%Dead 19%(Recovery 0%)

Outcome % at 1 year

20

Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359

TAH BTT Listed LEVEL 2, n=75

Months post implant

% S

urvi

val

Deaths/m

onthsHazard (early + late)

n=9359, Deaths=2280

Months % Survival 1 95%12 80%24 69%36 59%48 47%

Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359

n at risk: 9359 6195 4024 2736 1820 1194 711 408 174

21

Event: Death (censored at transplantation or recovery)

% FreedomMonths from TXPL 1 99%12 76%24 62%36 56%48 52%

Months post implant

% F

reed

om fr

om T

rans

plan

tatio

n

Transplants/months

Hazard(early + constant)

n=9359, Transplants= 2422

Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359

n at risk: 9359 6195 4024 2736 1820 1194 711 408 174

22

Event: Transplantation (censored at death or recovery)

% Freedom Months from Recovery 1 100%12 99%24 98%36 97%48 96%

Months post implant

% F

reed

om fr

om R

ecov

ery

Recovery/months

Hazard(constant)

n=9360, Recovery= 89

Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359

n at risk: 9359 6195 4024 2736 1820 1194 711 408 174

23

Event: Recovery (censored at death or transplantation)