predicting major outcomes after mcsd implant 1 risk factors for death, transplant, and recovery...
TRANSCRIPT
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)