Patients’ self-reported function, symptoms and HRQoL
before and 6 months after TAVI or surgery
International TVT nurse symposium
Copenhagen 2017
Karin Olsson, Umeå, Sweden
[email protected]
HEART CENTRE
HEART CENTRE
The overall study
Patients with severe aortic stenosis
TAVI
SAVR
Consecutive sampling
Age-matched with TAVI
Denied TAVI/SAVR
Interview
Interview
The day
before
TAVI/SAVR
At 6 months
Follow-up
HRQoL
EQ5D
SF36
Symptoms
Functions
6MWT
MMSE
KATZ ADLindex
NT-proBNP
After completing
the investigation
and informed
about being
denied TAVI
HRQoL
EQ5D
SF36
Symptoms
Functions
KATZ ADLindex
NT-proBNP
HEART CENTRE
HEART CENTRE
HEART CENTRE
The aim of the study was to describe patients’
self-reported outcomes in terms of physical
function, symptoms, dependence, HRQoL and
cognitive functions after TAVI and SAVR
HEART CENTRE
Methods
• HRQoL
SF 36
EQ5D
• Self-rated function and symptoms
• Dependence in daily life activities
Katz index of independence in ADL
• Cognitive function
MMSE
• Physical function
6 minutes’ walk test
• Heart function
NT-proBNP
TAVI
n = 24
SAVR
n = 24
p
Participants, n
24
24
1.000
Men/women, n
15/9
12/12
0.383
Age in years, md (min-max)
81 (60–90)
80 (61–88)
0.386
Living alone, n
15
11
0.247
Home care service, n
3
3
1.000
NYHA classes III and IV, n
24
13
0.006
NT - proBNP, md (min-max)
2042 (102–22740)
690 (79–6 119)
0.010
Cognitive function, MMSE, md (min-max)
28 (20–30)
29 (25–30)
0.017
Dependent P-ADL, n
5
0
0.050
Dependent I-ADL, n
15
10
0.149
Syncope, n
7
5
0.509
6 minutes’ walk test, meters, md (min-max)*
240 (98–496)
374 (228–570)
0.006
Diabetes, n
5
3
0.701
Chronic obstructive lung disease, n
7
2
0.137
Prior stroke, n
8
3
0.168
Peripheral vascular disease, n
7
1
0.048
Myocardial infarction <3 months before TAVI, n
4
0
0.109
Prior bypass graft surgery, n
13
0
0.000
EuroScore, md (min-max)
17.740 (5.010–56.190)
8.345 (2.230–36.780)
0.009
Creatinine, md (min-max)
92 (69–140)
77 (59–116)
0.014
HEART CENTRE
Sociodemographics
Function and symptom
Comorbidities
HEART CENTRE
Participants
Baseline
TAVI, n = 24
15 men, 9 women
SAVR, n = 24
12 men, 12 women
Deceased, n = 5
4 men, 1 woman
Deceased, n = 1
1 man
Six month follow-up
n = 19
11 men, 8 women
n = 23
11 men, 12 women
HEART CENTRE
Statistical analysis
Nonparametric tests were used due to small study population.
Data for categorical variables are reported as number and percent. Chi-Square
test or Fisher’s Exact test when appropriate, were used for comparisons between
groups, and McNemar’s test for comparison within groups.
Continuous variables are reported as median and range. Mann-Whitney U-tests
were used for comparison between groups, and Wilcoxon Signed Rank tests
within groups.
HEART CENTRE
TAVI
Questions
I. No limitation in ordinary activity.
Ordinary physical activity does not
cause undue fatigue, palpitation,
shortness of breath or chest pain.
II. Slight limitation in normal activity.
Ordinary physical activity results in
fatigue, palpitation, shortness of breath
or chest pain.
Before =24
n (%)
2 (8,3)
After =19
n (%)
2 (10,5)
4 (16,7)
11 (57,9)
P
Difference
in change
between
groups
P
0,001
0,467
SAVR
p
Before= 23
n (%)
3 (13,0)
After =22
n (%)
8 (36,4)
7 (30,4)
13 (59,1)
0,022
III. Marked limitation in normal activity.
Ordinary physical activity results in
fatigue, palpitation, shortness of breath
or chest pain.
13 (54,2)
6 (31,6)
12 (52,2)
0
IV. Unable to carry on any physical
activity without discomfort. Symptoms
from heart even at rest. If any physical
activity is undertaken, discomfort
increases.
5 (20,8)
0
1 (4,3)
1 (4,5)
HEART CENTRE
Change in self-reported function from
baseline to 6 months’ follow-up
TAVI, n=19
.
SAVR, n=23
I
I
I
I
II
II
II
II
III
III
III
III
IV
IV
IV
IV
p=0,022
p=0,001
HEART CENTRE
Symptoms of heart failure reported at baseline and at six months’ follow-up
TAVI
SAVR
Baseline
n = 24
Baseline,
survivals
n = 19
Follow up
n = 19
P
Baseline
n = 23
Baseline,
survivals
n = 22
Follow up
n = 22
P
You become short of breath if you walk briskly on flat
ground, n (%)
21 (91.3)
16 (82.2)
12 (70.6)
ns
18 (78.3)
17 (73.9)
9 (40.9)
0.008
You become short of breath if you walk with peers on flat
ground, n (%)
15 (65.2)
13 (68.4)
8 (47.1)
ns
12 (52.2)
11 (50.0)
7 (31.8)
ns
You have to stop and catch your breath if you walk on flat
ground at your own pace, n (%)
15* (65.2)
12 (63.2)
2 (11.8)
0.004
7*(30.4)
7 (31.8)
2 (9.1)
ns
You become short of breath when you dress or wash, n (%)
9 (39.1)
6 (33.3)
2 (11.1)
ns
6 (26.1)
5 (21.7)
1 (4.5)
ns
You get short of breath at rest, when you sit down, or at
rest, n (%)
7* (29.2)
4 (21.1)
0 (0)
ns
0* (0)
0 (0)
0 (0)
ns
You have to sit down and rest when you get home after a
walk, n (%)
18 (78.3)
14 (73.7)
7 (41.2)
0.031
12 (52.2)
11 (47.8)
9 (40.9)
ns
You wake up at night because of shortness of breath, n (%)
6* (25.0)
3 (15.8)
0 (0)
ns
0* (0)
0 (0)
1 (4.5)
ns
You have swelling of your legs during the day, n (%)
7 (33.3)
5 (26.3)
6 (33.3)
ns
7 (30.4)
7 (31.8)
3 (13.6)
ns
You are troubled by shortness of breath when you sleep
with your head low, n (%)
8* (34.8)
6 (33.3)
1 (5.6)
ns
2* (8.7)
2 (9.1)
2 (9.1)
ns
HEART CENTRE
The most limiting symptom related to heart disease reported at baseline and at six months’
follow-up
TAVI
SAVR
Baseline
n = 24
Follow-up
n = 19
Baseline
n = 24
Follow-up
n = 23
Shortness of breath, n (%)
12 (50.0)
7 (36.8)
14 (58.3)
6 (26)
Abnormal fatigue, n (%)
6 (25.0)
6 (31.6)
4 (16.7)
5 (21.7)
Chest pain, n (%)
4 (17)
1 (5.3)
1 (4.2)
0 (0)
Palpitations, n (%)
0 (0)
2 (10.5)
1 (4.2)
1 (4.3)
Vertigo, n (%)
1 (4.2)
0 (0)
2 (8.3)
2 (8.7)
No symptoms, n (%)
1 (4.2)
3 (15.8)
2 (8.3)
9 (39.1)
HEART CENTRE
Health related quality of life at baseline (all patients) and at six months’ follow-up
TAVI
Difference in
change
between
groups
SAVR
Baseline, n = 24
Follow-up, n = 19
P
Baseline, n = 24
Follow-up, n = 23
P
P
Physical function
37.5 (0–90)
55 (0–90)
0.003
62.5 (10–95)
80 (20–100)
0.007
0.303
Role physical
0 (0–100)
75 (0–100)
0.001
50 (0–100)
100 (0–100)
0.008
0.221
Bodily pain
62 (21–100)
100 (21–100)
0.009
78 (21–100)
84 (32–100)
0.115
0.347
General health
50 (20–82)
72 (35–95)
0.002
65 (25–97)
87 (25–100)
0.014
0.067
Vitality
47,5 (0–90)
60 (35–100)
0.016
55 (10–95)
75 (35–90)
0.001
0.889
Social function
87 (25–100)
100 (0–100)
0.415
100 (0–100)
100 (50–100)
0.059
0.903
Role emotional
100 (0–100)
100 (100–100)
0.038
100 (0–100)
100 (60–100)
0.039
0.446
Mental health
84 (0–96)
88 (52–100)
0.002
84 (36–100)
88 (72–100)
0.006
0.315
Index
0.64 (0.00–1.00)
0.80 (0.00–1.00)
0.002
0.73 (0.09–0.91)
0.90 (0.06–1.00)
0.001
0.899
VAS score
50 (10–90)
70 (25–100)
0.005
60 (30–90)
75 (25–100)
0.006
0.906
SF-36 median (range)
EQ-5D median (range)
HEART CENTRE
Health related quality of life at baseline (survivors) and at six months’ follow-up
TAVI
n = 19
SAVR
n = 23
Baseline
Follow-up
Baseline
SF-36, md (range)
Physical function
Role physical
Bodily pain
General health
Vitality
Social function
Role emotional
Mental health
40 (0-90)
0 (0-100)
62 (21-100)
50 (20-82)
50 (0-90)
100 (25-100)
100 (0-100)
84 (0-96)
p
55 (0-90)
0,003
75 (0-100)
0,001
100 (21-100) 0,009
72 (35-95)
0,002
60 (35-100)
0,016
100 (0-100)
0,415
100 (100-100) 0,038
88 (52-100)
0,002
60 (10-95)
50 (0-100)
84 (21-100)
65 (25-97)
55 (10-95)
100 (0-100)
100 (0-100)
84 (36-100)
EQ5D, md
Mobility
Self- care
Usual activities
Pain/discomfort
Anxiety/depression
2
1
2
2
1
1
1
1
1
1
0,096
0,157
0,366
0,001
0,105
Index
VAS-score
0,656
50
0,796
70
0,002
0,005
Difference
in change
between
groups
Follow-up
80 (20-100)
100 (0-100)
84 (32-100)
87 (25-100)
75 (35-90)
100 (50-100)
100 (65-100)
88 (72-100)
p
0,007
0,008
0,115
0,014
0,001
0,059
0,039
0,006
p
0,303
0,221
0,347
0,067
0,889
0,903
0,446
0,315
1
1
1
2
1
1
1
1
1
1
0,014
0,317
0,705
0,000
0,176
0,845
0,075
0,372
0,696
0,878
0,727
62,5
0,896
75
0,001
0,006
0,899
0,906
HEART CENTRE
Cognitive function
MMSE, md (min-max)
TAVI
Baseline = 24
28 (20 – 30)
Follow up =19
27 (18 – 30)
Heart failure
NT-proBNP, md (min-max)
SAVR
p
0,234
Baseline =24
29 (25 – 30)
Follow up = 23
29 (24 – 30)
TAVI
p
0,837
SAVR
Baseline = 24
Follow up =16
P
Baseline =24
Follow up = 17
P
2343 (102 – 22740)
1730 (190 -3927)
0,039
690 (79 – 6119)
425 (78 -2208)
0,084
Physical function
6MWT, meters, md (min-max)
TAVI
Baseline, n=21
240 (98-496)
Follow up, n=14
356 (100-530)
p
0,039
Result
Thank you!