Background
Methods
Data collection
Statistical analysis
Results
Baseline and post-procedural parameters (N = 169) | ||||||
At baseline (n = 169) | ||||||
mean | SD | |||||
Age (in years) | 82.15 | 5.16 | ||||
logistic EuroSCORE | 16.57 | 11.54 | ||||
At baseline (n = 169) | During follow-up (n = 2294) | |||||
Mean | SD | Mean | SD | |||
HrQoLIndex
| 0.78 | 0.23 | 0.77 | 0.25 | ||
5 EQ-5D dimensions | No problems | Some problems | Extreme problems | No problems | Some problems | Extreme problems |
Mobility | 50 % | 50 % | 0 % | 39 % | 58 % | 3 % |
Self-Care | 79 % | 20 % | 2 % | 70 % | 24 % | 6 % |
Usual Activities | 53 % | 40 % | 8 % | 44 % | 44 % | 12 % |
Pain/Discomfort | 51 % | 49 % | 8 % | 33 % | 62 % | 5 % |
Anxiety/Depression | 64 % | 30 % | 6 % | 69 % | 28 % | 3 % |
Heart Function | Mean | SD | Mean | SD | ||
NYHA SCORE | 2.57 | 0.7 | 1.36 | 1.08 | ||
CCS SCORE | 1.23 | 1.32 | 0.5 | 0.83 | ||
Current status of the assistance | No external help or intra-familial help only | Assisted living and/or home care services | Short or long-term care or temporal hospitalization | No external help or intra-familial help only | Assisted living and/or home care services | Short or long-term care or temporal hospitalization |
77 % | 13 % | 10 % | 73 % | 18 % | 9 % | |
Cardiological events among TAVI and AVR patients | In-hospital | Post-discharge | ||||
ASB life threatening/disabling | 12 | 0 | ||||
ASB major/minor | 12 | 0 | ||||
NASB life threatening/disabling | 6 | 2 | ||||
NASB major/minor | 11 | 8 | ||||
VASC major/minor | 24 | 3 | ||||
Stroke/TIA | 4 | 2 | ||||
AKIN 1 | 16 | 1 | ||||
AKIN 2 | 6 | 1 | ||||
AKIN 3 | 10 | 6 | ||||
Severe cardiac dysrhythmia | 48 | 6 | ||||
Other complications | 12 | 3 |
Overall, post-discharge and distance-to-death effects during the study period
Quality of life | Heart function | Status of assistance | |||||||
EQ-5DIndex
| Five EQ-5D dimensions | ||||||||
(1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) | (9) | |
EQ-5DIndex
| Mobility | Looking after myself | Doing usual activities | Having pain or discomfort | Feeling worried, sad or unhappy | NYHA score | CCS score | Status of assistance | |
Point estimate | Odds ratios from the ordered logistic regression model | ||||||||
Last follow-up before death | −0.495***
| 85.56***
| 210.2***
| 79.70**
| 23.66***
| 44.06***
| 4.653 | 1.258 | 189.7***
|
Second last follow-up before death | −0.305***
| 14.40**
| 26.95***
| 7.132*
| 16.94***
| 15.65***
| 2.042 | 2.203 | 18.08*
|
Third from last follow-up before death | −0.221***
| 11.96 | 23.42***
| 6.753 | 2.672 | 3.567 | 5.171**
| 1.477 | 58.83***
|
Fourth from last follow-up before death | −0.204***
| 8.480*
| 10.11**
| 6.338 | 3.433 | 8.167**
| 1.807 | 1.911 | 22.58***
|
Fifth from last follow-up before death | −0.139**
| 5.282 | 12.73**
| 8.027 | 1.384 | 2.331 | 1.169 | 1.247 | 21.37*
|
Sixth from last follow-up before death | −0.0983*
| 2.033 | 3.203 | 2.902 | 2.918 | 3.273 | 1.464 | 0.996 | 7.387 |
Overall trend | −0.00143 | 1.083***
| 1.040 | 0.963 | 1.042***
| 0.979 | 1.053***
| 1.024 | 1.060*
|
Month 1 post-discharge | −0.0460**
| 2.878***
| 2.358*
| 2.273**
| 1.391 | 1.487 | 1.939**
| 1.197 | 2.652*
|
Constant | 0.789***
| ||||||||
N
| 2294 | 2328 | 2332 | 2330 | 2330 | 2317 | 2252 | 2254 | 1980 |
Between-group differences and baseline-adjustment over the two-year period
Quality of life | Heart function | Status of assistance | |||||||
EQ-5DIndex
| five EQ-5D dimensions | ||||||||
(1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) | (9) | |
EQ-5DIndex
| Mobiliy | Looking after myself | Doing usual activities | Having pain or discomfort | Feeling worried, sad or unhappy | NYHA score | CCS score | Status of assistance | |
Point estimate | Odds ratios from the ordered logistic regression model | ||||||||
Value at baseline | 0.321***
| 7.314***
| 18.30***
| 9.356***
| 2.222***
| 2.756***
| 2.419***
| 1.378***
| 9.049**
|
EuroSCORE at baseline | −0.000761 | 1.029 | 1.046 | 1.040*
| 0.999 | 1.011 | 0.992 | 1.000 | 0.985 |
TAVR | Reference | Reference | Reference | Reference | Reference | Reference | Reference | Reference | Reference |
SAVR | 0.0532 | 0.209**
| 0.754 | 0.396*
| 0.459**
| 0.413*
| 1.258 | 0.912 | 0.0441***
|
SAVRplus | −0.112*
| 3.162 | 6.843 | 3.559 | 2.185 | 2.487 | 2.416 | 1.132 | 1.129 |
DRUG | −0.180**
| 14.42***
| 1.463 | 1.948 | 2.114 | 3.667***
| 26.69***
| 1.416 | 2.174 |
Last follow-up before death | −0.536***
| 111.5***
| 291.0***
| 149.0***
| 34.40***
| 53.33***
| 4.141 | 1.816 | 123.2**
|
Second last follow-up before death | −0.334***
| 16.37**
| 31.55***
| 8.390*
| 19.85***
| 16.00***
| 1.826 | 1.752 | 16.09*
|
Third from last follow-up before death | −0.246***
| 15.48*
| 30.99***
| 9.799*
| 3.929 | 3.782 | 5.026*
| 1.817 | 55.18**
|
Fourth from last follow-up before death | −0.225***
| 9.108*
| 12.66***
| 7.110 | 4.175 | 8.558**
| 1.670 | 2.307 | 24.06**
|
Fifth from last follow-up before death | −0.157***
| 6.018 | 15.68**
| 11.47*
| 1.822 | 2.491 | 0.985 | 1.371 | 16.51*
|
Sixth from last follow-up before death | −0.108**
| 2.088 | 3.711 | 3.231 | 3.290 | 3.457 | 1.360 | 1.129 | 16.89 |
Overall trend | −0.00140 | 1.087***
| 1.041 | 0.967 | 1.043***
| 0.978 | 1.051***
| 1.021 | 1.071*
|
Month 1 post-discharge | −0.0425**
| 2.139*
| 2.038*
| 2.282**
| 1.212 | 1.346 | 1.853*
| 1.047 | 3.206*
|
Constant | 0.554***
| ||||||||
N
| 2159 | 2189 | 2193 | 2191 | 2191 | 2156 | 2119 | 1952 | 1317 |
Clinical events and complications
Quality of life | Heart function | Status of assistance | |||||||
EQ-5DIndex
| Five EQ-5D dimensions | ||||||||
(1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) | (9) | |
EQ-5DIndex
| Mobility | Looking after myself | Doing usual activities | Having pain or discomfort | Feeling worried, sad or unhappy | NYHA score | CCS score | Status of assistance | |
Point estimate | Odds ratios from the ordered logistic regression model | ||||||||
Value at baseline | 0.350***
| 14.19***
| 34.09***
| 10.96***
| 1.671*
| 2.751***
| 2.457***
| 1.398***
| 10.82**
|
ASB life threatening/disabling | −0.0463 | 12.68**
| 0.680 | 0.199 | 2.860 | 0.771 | 0.123 | 0.188 | 0.104 |
ASB major/minor | 0.0985*
| 0.587 | 0.499 | 0.201**
| 0.182*
| 0.121*
| 0.762 | 0.673 | 0.342 |
NASB life threatening/disabling | −0.447***
| 584.6**
| 54.93 | 7.752 | 0.739 | 47.86*
| 1.410 | 1.591 | 86.32*
|
NASB major/minor | −0.0199 | 1.188 | 0.688 | 0.597 | 1.311 | 0.573 | 1.180 | 0.813 | 4.088 |
VASC major/minor | −0.00695 | 0.282 | 0.971 | 2.029 | 0.833 | 2.110 | 1.422 | 0.660 | 6.198 |
Stroke/TIA | −0.161*
| 8.298**
| 1.358 | 4.179 | 6.661 | 2.561 | 0.343 | 0.380 | 0.958 |
AKIN 1 | 0.0659 | 1.270 | 1.104 | 0.357 | 0.430 | 0.742 | 0.547 | 0.601 | 0.718 |
AKIN 2 | −0.158*
| 1.297 | 7.126 | 102.2**
| 0.814 | 0.340 | 81.36*
| 104.2**
| 21.79 |
AKIN 3 | −0.177**
| 15.75***
| 21.53**
| 7.419*
| 2.908 | 3.495 | 1.243 | 1.404 | 1.955 |
Arrhythmia | −0.0377 | 2.393 | 3.153 | 1.954 | 1.817 | 2.200 | 3.490 | 0.234*
| 1.270 |
Other complications | 0.0330 | 2.617 | 0.933 | 0.457 | 0.366 | 0.402 | 1.380 | 5.237*
| 1.057 |
Last follow-up before death | −0.493***
| 81.93***
| 154.9***
| 48.14**
| 29.90***
| 32.98***
| 2.877 | 1.335 | 144.8**
|
Second last follow-up before death | −0.270***
| 11.50**
| 23.04***
| 5.949 | 15.13***
| 11.13***
| 1.542 | 1.786 | 12.95 |
Third from last follow-up before death | −0.204***
| 8.142 | 17.64**
| 4.509 | 1.996 | 3.602 | 3.855*
| 1.377 | 66.29**
|
Fourth from last follow-up before death | −0.176***
| 7.797*
| 11.09**
| 5.952 | 2.471 | 7.750**
| 1.581 | 2.016 | 23.22*
|
Fifth from last follow-up before death | −0.150***
| 4.843 | 13.36**
| 8.091 | 1.600 | 2.446 | 0.926 | 1.217 | 25.23*
|
Sixth from last follow-up before death | −0.104*
| 1.800 | 3.205 | 2.907 | 3.803 | 2.932 | 1.259 | 1.081 | 35.30*
|
Overall trend | −0.00165 | 1.085***
| 1.045 | 0.966 | 1.044***
| 0.983 | 1.056***
| 1.020 | 1.088**
|
Month 1 post-discharge | −0.0233 | 1.602 | 1.433 | 2.066*
| 1.465 | 1.130 | 1.370 | 1.599 | 2.774 |
Constant | 0.528***
| ||||||||
N
| 2212 | 2246 | 2256 | 2254 | 2254 | 2219 | 2182 | 2022 | 1357 |
Time-to-death adjustment (six months) | Exclusion of cases of mortality (six months prior to death) | EQ-5DIndex = 0 in month of death | ||||
---|---|---|---|---|---|---|
(1) | (2) | (3) | (4) | (5) | (6) | |
EQ-5DIndex
| EQ-5DIndex
| EQ-5DIndex
| EQ-5DIndex
| EQ-5DIndex
| EQ-5DIndex
| |
Value at baseline | 0.348***
| 0.346***
| 0.333***
| 0.331***
| 0.333***
| 0.331***
|
ASB life threatening/disabling | −0.0593 | −0.140*
| 0.0356 | −0.0497 | −0.0599 | −0.121 |
…at the second follow-up after event | −0.145*
| −0.155*
| −0.0993 | |||
…at the third follow-up after event | −0.163**
| −0.0950 | −0.145*
| |||
NASB life threatening/disabling | −0.449***
| −0.493***
| −0.457***
| −0.508***
| −0.448***
| −0.465***
|
…at the second follow-up after event | −0.114 | −0.140 | −0.101 | |||
…at the third follow-up after event | 0.103 | 0.0936 | 0.109 | |||
Stroke / TIA | −0.147*
| −0.206**
| −0.145*
| −0.210**
| −0.147*
| −0.199*
|
…at the second follow-up after event | −0.123 | −0.146*
| −0.121 | |||
…at the third follow-up after event | −0.0319 | −0.0286 | −0.0307 | |||
AKIN 2 | −0.167*
| −0.226**
| −0.267**
| −0.270**
| −0.169*
| −0.272**
|
…at the second follow-up after event | −0.142 | −0.0428 | −0.195*
| |||
…at the third follow-up after event | 0.0657 | 0.0150 | 0.0508 | |||
AKIN 3 | −0.173**
| −0.186**
| −0.235**
| −0.293***
| −0.381***
| −0.418***
|
…at the second follow-up after event | −0.113 | −0.177*
| −0.235**
| |||
…at the third follow-up after event | −0.00684 | −0.0338 | −0.0939 | |||
Other complications | 0.00548 | 0.00571 | 0.0134 | 0.0140 | 0.00464 | 0.00368 |
Last follow-up before death | −0.493***
| −0.487***
| ||||
Second last follow-up before death | −0.275***
| −0.272***
| ||||
Third from last follow-up before death | −0.210***
| −0.217***
| ||||
Fourth from last follow-up before death | −0.180***
| −0.189***
| ||||
Fifth from last follow-up before death | −0.154***
| −0.166***
| ||||
Sixth from last follow-up before death | −0.108**
| −0.116**
| ||||
Overall trend | −0.00161 | −0.00222**
| −0.00195*
| −0.00249**
| −0.00322***
| −0.00386***
|
Month 1 post-discharge | −0.0230 | −0.0283 | −0.0256 | −0.0301 | −0.0163 | −0.0218 |
Constant | 0.529***
| 0.543***
| 0.548***
| 0.559***
| 0.508***
| 0.523***
|
N
| 2212 | 2212 | 2102 | 2102 | 2250 | 2250 |