Educatio n War Era Cardiac Surgery alth-Related Quality of Life (HRQO in Survivors after the Fontan Operat James K. Kirklin, MD Manisha Kukreja, MBBS, MPH David C. Cleveland, MD. Robert J Dabal, MD. Ayesha S. Bryant, MSPH, MD
Education War Era Cardiac Surgery Health-Related Quality of Life (HRQOL) in Adult Survivors after the Fontan Operations James K. Kirklin, MD Manisha Kukreja,
Jan 02, 2016
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Education War Era Cardiac SurgeryHealth-Related Quality of Life (HRQOL)
in Adult Survivors after the Fontan Operations
James K. Kirklin, MD Manisha Kukreja, MBBS, MPHDavid C. Cleveland, MD.Robert J Dabal, MD. Ayesha S. Bryant, MSPH, MD
Education War Era Cardiac SurgeryPresenter DisclosureJames Kirklin
James K. Kirklin, MD – None Manisha Kukreja, MBBS, MPH – NoneDavid C. Cleveland, MD., Robert J Dabal, MD., Ayesha S. Bryant, MSPH, MD – None
Education War Era Cardiac Surgery
• Ascertain the long-term HRQOL of adult patients who underwent a childhood Fontan operation for functional univentricular cardiac anomalies
HRQOL After Fontan HRQOL After Fontan Primary Objective
Education War Era Cardiac Surgery
Secondary Objectives
HRQOL After FontanHRQOL After Fontan
• Compare long-term QOL of Fontan group to that of heart transplant recipients and to a healthy general population
Hazard Functions
Per
cen
t su
rviv
al
Years % survival N at risk
1 95% 190
5 91% 116
10 88% 64
20 77% 14
Years after Fontan operation
Fontan operation (UAB); 1988 – 2011 using internal or external PTFE tubes (N=207)
Hazard
(Death
s/Year)
Early + Constant phase model
Hazard=1.3%/year
Hazard Functions
Per
cen
t su
rviv
al
Years % survival N at risk
1 95% 190
5 91% 116
10 88% 64
20 77% 14
Years after Fontan operation
Fontan operation (UAB); 1988 – 2011 using internal or external PTFE tubes (N=207)
Hazard
(Death
s/Year)
Early + Constant phase model
Hazard=1.3%/year
Education War Era Cardiac SurgeryHRQOL After FontanStudy Population
Fontan Inclusion: 49 Surviving adult patients (82% response rate) 19 years and older, who underwent a pediatric Fontan operation at UAB between 1988 – 2012, and who responded to the QOL survey
Heart Transplant Inclusion: 13 Surviving adult heart transplant recipients (93% response rate) 19 years and older, transplanted at pediatric age, no H/O previous Fontan, who responded to the QOL survey.
Education War Era Cardiac Surgery
• 36 questions measuring 8 domains of health : PHYSICAL COMPONENT - Physical functioning - Role limitations due to physical health - Bodily pain - General health MENTAL HEALTH COMPONENT - Vitaliy - Social functioning
- Role limitations by emotional health - Mental health
HRQOL Fontan StudyHRQOL Fontan StudySF – 36 Health Survey
Education War Era Cardiac Surgery
• The HRQOL scores of the Fontan patients were compared to H Tx patients scores and normalized against the general US population.• For each domain, scores ranged from 0 to 100, a
higher score indicating a better health state.• National normalized mean value is set at 50
( validated by Quality Metric Inc, Lincoln, RI) with SD of 10
HRQOL Fontan StudyHRQOL Fontan StudySF – 36 Health Survey
Education War Era Cardiac SurgeryHRQOL After FontanMethods
• Study Design: A cross-sectional survey design using the Standard Short Form 36 (SF-36), self administered by patients • Survey completion date 7/15/2014• Average duration of follow up for Fontan group was 18 years ( range 3-24) , with 90% >10 yrs• Average duration of f/u for C Tx group was 13 yrs (range 3-23 yrs).
Overall mental component standardized scores by different age groups
Age Gr 18-24 25-34 35-44 45-54 55-64 65-74 75+ Fontan 49.94 49 56.28 0 50.98 0 0 US pop 49 48.48 48.28 49.2 51.36 53.71 53.49# in Sample 26 19 3 0 1 0 0
Overall mental component standardized scores by different age groups
Age Gr 18-24 25-34 35-44 45-54 55-64 65-74 75+ Fontan 49.94 49 56.28 0 50.98 0 0 US pop 49 48.48 48.28 49.2 51.36 53.71 53.49# in Sample 26 19 3 0 1 0 0
Overall mental component standardized scores by different age groups
Age Gr 18-24 25-34 35-44 45-54 55-64 65-74 75+ Fontan 49.94 49 56.28 0 50.98 0 0 US pop 49 48.48 48.28 49.2 51.36 53.71 53.49# in Sample 26 19 3 0 1 0 0
Mean Standardized HRQOL scores by cohort and of the general population (age controlled to 25 to 34) years using the SF-36v2 survey
Mean Standardized HRQOL scores by cohort and of the general population (age controlled to 25 to 34) years using the SF-36v2 survey
Mean Standardized HRQOL scores by cohort and of the general population (age controlled to 25 to 34) years using the SF-36v2 survey
Mean Standardized HRQOL scores by cohort and of the general population (age controlled to 25 to 34 years) using the SF-36v2 survey
QOL after Fontan Operations; UAB 1988-2011; Group=Fontan;
N=49
Overall standardized physical component scores (PCS) (age 25-34 yrs)
P
erc
en
t ≤
Sta
ted
Ove
rall
Ph
ysi
cal
Co
mp
on
en
t S
co
res
Median, (range): 52 (28-70)
55.4351.3
US
med
ian
75th percentile
50th percentile
25th percentile
QOL after Fontan Operations; UAB 1988-2011; Group=Fontan;
N=49
Overall standardized physical component scores (PCS) (age 25-34 yrs)
P
erc
en
t ≤
Sta
ted
Ove
rall
Ph
ysi
cal
Co
mp
on
en
t S
co
res
Median, (range): 52 (28-70)
55.4351.3
US
med
ian
75th percentile
50th percentile
25th percentile
QOL after Fontan Operations; UAB 1988-2011; Group=Fontan;
N=49
Overall standardized physical component scores (PCS) (age 25-34 yrs)
P
erc
en
t ≤
Sta
ted
Ove
rall
Ph
ysi
cal
Co
mp
on
en
t S
co
res
Median, (range): 52 (28-70)
55.4351.3
US
med
ian
75th percentile
50th percentile
25th percentile
QOL after Fontan Operations; UAB 1988-2011; Group=Fontan;
N=49
Overall standardized physical component scores (PCS) (age 25-34 yrs)
P
erc
en
t ≤
Sta
ted
Ove
rall
Ph
ysi
cal
Co
mp
on
en
t S
co
res
Median, (range): 52 (28-70)
55.4351.3
US
med
ian
75th percentile
50th percentile
25th percentile
QOL after Fontan Operations; UAB 1988-2011; Group=Fontan;
N=49
Overall standardized mental component scores (MCS) (age 25-34 yrs)P
erc
en
t ≤
Sta
ted
Ove
rall
Men
tal C
om
po
ne
nt
Sc
ore
s
Median, (range): 55 (18-66)
25th percentile
50th percentile
75th percentile
US
med
ian
51.9745.17
QOL after Fontan Operations; UAB 1988-2011; Group=Fontan;
N=49
Overall standardized mental component scores (MCS) (age 25-34 yrs)P
erc
en
t ≤
Sta
ted
Ove
rall
Men
tal C
om
po
ne
nt
Sc
ore
s
Median, (range): 55 (18-66)
25th percentile
50th percentile
75th percentile
US
med
ian
51.9745.17
QOL after Fontan Operations; UAB 1988-2011; Group=Fontan;
N=49
Overall standardized mental component scores (MCS) (age 25-34 yrs)P
erc
en
t ≤
Sta
ted
Ove
rall
Men
tal C
om
po
ne
nt
Sc
ore
s
Median, (range): 55 (18-66)
25th percentile
50th percentile
75th percentile
US
med
ian
51.9745.17
QOL after Fontan Operations; UAB 1988-2011; Group=Fontan;
N=49
Overall standardized mental component scores (MCS) (age 25-34 yrs)P
erc
en
t ≤
Sta
ted
Ove
rall
Men
tal C
om
po
ne
nt
Sc
ore
s
Median, (range): 55 (18-66)
25th percentile
50th percentile
75th percentile
US
med
ian
51.9745.17
Education War Era Cardiac Surgery
Study Limitations
• This was a cross sectional study which depended on patient self-reporting and therefore could not explore the temporal trends in health perception.
• We cannot exclude the possibility that non-responders may have a different perception of their HRQOL.
Education War Era Cardiac Surgery
Inferences
• Despite the long-term imponderables of the Fontan physiology, the majority of patients surviving an average of nearly 2 decades enjoy a good health-related QOL.
•Although their perception of the physical components of health lags behind an age-controlled normal population, it’s encouraging that their mental health and emotional scores were equal to those of the normal population.
Education War Era Cardiac Surgery
Inferences
• When comparing surgical strategies (such as complex 2-ventricle repairs, Fontan procedure, transplantation, etc.) for complex conditions such as univentricular hearts and variants, HRQOL will increasingly become an important component of the overall calculus of “outcome” in the late phase and an ingredient of truly informed patient consent.
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