Table 3.
Adjusted between group differences according to longitudinal mixed effects models
| NRCA TA-TAVR vs RCT TA-TAVR | NRCA TA-TAVR vs RCT SAVR | |||
|---|---|---|---|---|
| Scale/Timepoint | Predicted Mean Difference**: NRCA - RCT (95% CI) | p-value | Predicted Mean Difference**: NRCA - RCT (95% CI) | p-value |
| KCCQ Summary | ||||
| 1 month | 4.2 (−0.9, 9.3) | 0.11 | −3.8 (−9.6,2.0) | 0.20 |
| 6 months | 2.2 (−2.1,6.4) | 0.32 | −2.3 (−7.0,2.5) | 0.35 |
| 12 months | −0.3 (−5.5,4.9) | 0.91 | −0.4 (−6.2,5.3) | 0.88 |
| KCCQ Physical Limitations | ||||
| 1 month | 6.2 (−0.4,12.8) | 0.07 | −2.1 (−9.6,5.4) | 0.58 |
| 6 months | 4.8 (−0.6,10.3) | 0.08 | −2.2 (−8.3,3.8) | 0.47 |
| 12 months | 3.1 (−3.6,9.9) | 0.36 | −2.4 (−9.6,4.8) | 0.52 |
| KCCQ Total Symptoms | ||||
| 1 month | 1.7 (−3.5,6.9) | 0.51 | −3.2 (−9.0,2.5) | 0.27 |
| 6 months | 5.5 (−0.5,10.5) | 0.03 | −7.4 (−12.8, −1.9) | 0.01 |
| 12 months | 0.9 (−4.2,6.0) | 0.73 | −0.3 (−5.8,5.2) | 0.91 |
| KCCQ Quality of Life | ||||
| 1 month | 3.4 (−2.4,9.3) | 0.25 | −3.9 (−10.3,2.6) | 0.24 |
| 6 months | 0.9 (−3.7,5.6) | 0.70 | −1.5 (−6.6,3.6) | 0.56 |
| 12 months | −2.1 (−8.2,4.0) | 0.50 | 1.3 (−5.3,7.9) | 0.70 |
| KCCQ Social Limitation | ||||
| 1 month | 8.5 (−1.0,16.1) | 0.03 | 0.8 (−7.7,9.3) | 0.86 |
| 6 months | 2.4 (−3.5,8.3) | 0.42 | 0.4 (−6.2,7.0) | 0.90 |
| 12 months | −5.0 (−13.0,3.0) | 0.22 | 0.0 (−8.5,8.4) | 1.00 |
| SF-12 Physical | ||||
| 1 month | 1.4 (−0.3,3.2) | 0.11 | 1.1 (−1.0,3.3) | 0.30 |
| 6 months | 1.3 (−0.4,2.9) | 0.15 | −1.4 (−3.9,1.1) | 0.26 |
| 12 months | 1.0 (−1.5,3.5) | 0.42 | 0.4 (−2.4,3.2) | 0.79 |
| SF-12 Mental | ||||
| 1 month | 2.7 (0.4,5.0) | 0.02 | −0.9 (−3.5,1.7) | 0.48 |
| 6 months | 2.1 (0.3,3.9) | 0.02 | −0.9 (−2.8,1.1) | 0.39 |
| 12 months | 1.5 (−1.1,4.0) | 0.26 | −0.8 (−3.5,1.9) | 0.56 |
| EQ-5D Utilities | ||||
| 1 month | 0.06 (0.01,0.11) | 0.02 | 0.00 (−0.06, 0.05) | 0.88 |
| 6 months | 0.04 (0.00,0.08) | 0.04 | −0.02 (−0.06, 0.03) | 0.46 |
| 12 months | 0.02 (−0.03,0.07) | 0.41 | −0.03 (−0.09, 0.03) | 0.28 |
*
Longitudinal mixed effects models adjusted for age, gender, COPD, and baseline HRQoL
**
Positive values indicate better HRQoL with NRCA TA-TAVR, whereas negative values indicate worse HRQOL with NRCA TA—TAVR.
COPD = chronic obstructive pulmonary disease; EQ-5D = EuroQol 5D; HRQoL = health-related quality-of-life; KCCQ = Kansas City Cardiomyopathy Questionnaire; NRCA = non-randomized continued access registry; SAVR = surgical aortic valve replacement; SF-12 = Medical Outcomes Study Short-Form 12; TA = transapical; TAVR = transcatheter aortic valve replacement.