Table 4.
Between group comparisons of health status after TAVR, stratified by access site
| Iliofemoral | Non-Iliofemoral | Interaction P value† |
|||
|---|---|---|---|---|---|
| Scale/Time Point | Adjusted Mean Difference* TAVR-AVR (95% CI) |
P value | Adjusted Mean Difference* TAVR-AVR (95% CI) |
P value | |
| KCCQ Overall Summary | |||||
| 1 month | 16.7 (12.0 to 21.3) | <0.001 | 3.6 (−6.6 to 13.9) | 0.486 | 0.019 |
| 6 months | 2.1 (−1.9 to 6.1) | 0.295 | −4.6 (−13.1 to 3.8) | 0.282 | 0.138 |
| 1 year | 1.3 (−3.0 to 5.5) | 0.554 | 2.0 (−8.1 to 12.1) | 0.700 | 0.899 |
| KCCQ Physical Limitations | |||||
| 1 month | 17.8 (12.3 to 23.3) | <0.001 | 1.6 (−10.9 to 14.1) | 0.805 | 0.016 |
| 6 months | 1.6 (−3.3 to 6.5) | 0.518 | −7.6 (−17.8 to 2.6) | 0.144 | 0.096 |
| 1 year | 1.6 (−3.6 to 6.8) | 0.545 | 0.9 (−11.4 to 13.1) | 0.888 | 0.914 |
| KCCQ Total Symptoms | |||||
| 1 month | 9.9 (5.6 to 14.3) | <0.001 | 2.3 (−7.2 to 11.9) | 0.632 | 0.139 |
| 6 months | 1.1 (−2.6 to 4.9) | 0.550 | −3.2 (−11.0 to 4.5) | 0.410 | 0.290 |
| 1 year | −0.2 (−4.4 to 3.9) | 0.908 | −0.8 (−10.8 to 9.3) | 0.883 | 0.927 |
| KCCQ Quality of Life | |||||
| 1 month | 19.0 (13.7 to 24.3) | <0.001 | 8.3 (−3.5 to 20.2) | 0.169 | 0.098 |
| 6 months | 4.1 (−0.5 to 8.6) | 0.078 | −2.3 (−11.8 to 7.2) | 0.638 | 0.211 |
| 1 year | 0.2 (−4.5 to 4.9) | 0.944 | −1.1 (−12.2 to 10.1) | 0.853 | 0.842 |
| KCCQ Social Limitation | |||||
| 1 month | 18.6 (11.8 to 25.4) | <0.001 | 7.1 (−8.2 to 22.5) | 0.360 | 0.161 |
| 6 months | 1.4 (−4.2 to 7.0) | 0.620 | −1.1 (−12.8 to 10.6) | 0.850 | 0.686 |
| 1 year | 0.2 (−5.7 to 6.1) | 0.948 | 8.4 (−5.7 to 22.4) | 0.241 | 0.290 |
| SF-12 Physical | |||||
| 1 month | 4.9 (3.1 to 6.7) | <0.001 | 3.2 (−0.9 to 7.4) | 0.126 | 0.459 |
| 6 months | −0.3 (−2.1 to 1.4) | 0.721 | 0.1 (−3.5 to 3.7) | 0.975 | 0.844 |
| 1 year | 0.1 (−2.0 to 2.2) | 0.927 | 2.9 (−1.9 to 7.8) | 0.237 | 0.290 |
| SF-12 Mental | |||||
| 1 month | 6.1 (3.8 to 8.5) | <0.001 | −0.1 (−5.4 to 5.1) | 0.957 | 0.025 |
| 6 months | 2.2 (0.3 to 4.1) | 0.026 | −1.0 (−5.0 to 2.9) | 0.609 | 0.136 |
| 1 year | 0.8 (−1.3 to 3.0) | 0.456 | 1.3 (−3.7 to 6.3) | 0.610 | 0.863 |
| EQ-5D Utility | |||||
| 1 month | 0.117 (0.075 to 0.159) | <0.001 | 0.042 (−0.051 to 0.136) | 0.375 | 0.140 |
| 6 months | 0.012 (−0.021 to 0.045) | 0.486 | −0.044 (−0.115 to 0.026) | 0.219 | 0.140 |
| 1 year | 0.016 (−0.019 to 0.050) | 0.378 | −0.018 (−0.100 to 0.064) | 0.667 | 0.459 |
KCCQ, Kansas City Cardiomyopathy Questionnaire; SF-12, Short Form-12
*
Differences reflect the comparison of TAVR vs. AVR and are based on longitudinal growth curve models (see Methods for details)
†
p-value for the interaction tem between treatment assignment and access site