Table 2.
Mean Scores and Within-Group Changes Compared With Baseline
| TMVr |
Standard Care |
|||||
|---|---|---|---|---|---|---|
| Mean ± SD | Paired Difference (95% CI) | P-Value | Mean ± SD | Paired Difference (95% CI) | P-Value | |
| KCCQ Overall Summary | ||||||
| Baseline | 53.2 ± 22.8 | 51.6 ± 23.3 | ||||
| 1 month | 70.9 ± 21.1 | 16.9 (14.2 to 19.6) | <0.001 | 54.6 ± 24.7 | 2.1 (−0.1 to 4.3) | 0.06 |
| 6 months | 73.0 ± 21.3 | 18.5 (15.4 to 21.6) | <0.001 | 59.0 ± 24.7 | 5.3 (2.4 to 8.3) | 0.001 |
| 12 months | 71.8 ± 22.2 | 17.0 (13.6 to 20.3) | <0.001 | 60.2 ± 24.5 | 5.1 (1.5 to 8.6) | 0.005 |
| 24 months | 70.9 ± 23.8 | 18.4 (13.7 to 23.2) | <0.001 | 61.2 ± 24.4 | 5.8 (0.2 to 11.4) | 0.04 |
| KCCQ Physical Limitations | ||||||
| Baseline | 58.3 ± 24.5 | 55.7 ± 26.0 | ||||
| 1 month | 69.9 ± 23.8 | 11.1 (8.3 to 13.9) | <0.001 | 55.8 ± 26.3 | −0.5 (−3.2 to 2.1) | 0.69 |
| 6 months | 72.2 ± 22.7 | 13.1 (9.9 to 16.3) | <0.001 | 59.0 ± 26.8 | 0.8 (−2.6 to 4.2) | 0.64 |
| 12 months | 69.7 ± 24.1 | 9.4 (5.9 to 12.9) | <0.001 | 57.7 ± 27.7 | −0.4 (−4.4 to 3.7) | 0.86 |
| 24 months | 67.6 ± 26.3 | 8.8 (3.7 to 14.0) | <0.001 | 59.5 ± 27.4 | 2.9 (−3.0 to 8.9) | 0.33 |
| KCCQ Total Symptoms | ||||||
| Baseline | 60.3 ± 24.9 | 58.9 ± 24.7 | ||||
| 1 month | 76.9 ± 20.9 | 15.5 (12.7 to 18.4) | <0.001 | 61.1 ± 24.9 | 1.3 (−1.2 to 3.8) | 0.31 |
| 6 months | 76.9 ± 22.4 | 14.9 (11.8 to 18.1) | <0.001 | 67.0 ± 24.0 | 5.5 (2.3 to 8.7) | 0.001 |
| 12 months | 76.2 ± 22.3 | 13.4 (9.9 to 16.8) | <0.001 | 68.4 ± 22.6 | 5.7 (1.8 to 9.6) | 0.004 |
| 24 months | 74.8 ± 23.5 | 14.8 (10.2 to 19.4) | <0.001 | 68.8 ± 22.4 | 7.4 (1.2 to 13.6) | 0.02 |
| KCCQ Quality of Life | ||||||
| Baseline | 45.2 ± 25.6 | 44.7 ± 25.8 | ||||
| 1 month | 68.9 ± 23.8 | 23.2 (20.0 to 26.4) | <0.001 | 49.8 ± 27.6 | 4.5 (1.8 to 7.1) | 0.001 |
| 6 months | 70.3 ± 24.4 | 24.6 (20.9 to 28.3) | <0.001 | 55.9 ± 28.1 | 9.0 (5.6 to 12.5) | <0.001 |
| 12 months | 71.4 ± 24.8 | 25.4 (21.3 to 29.4) | <0.001 | 57.4 ± 27.3 | 8.9 (4.9 to 12.9) | <0.001 |
| 24 months | 71.6 ± 26.0 | 28.3 (23.0 to 33.6) | <0.001 | 58.5 ± 28.1 | 7.5 (1.1 to 13.8) | 0.02 |
| KCCQ Social Limitation | ||||||
| Baseline | 49.5 ± 29.2 | 46.8 ± 30.4 | ||||
| 1 month | 67.9 ± 29.3 | 17.7 (13.9 to 21.5) | <0.001 | 50.8 ± 32.1 | 2.2 (−0.9 to 5.4) | 0.17 |
| 6 months | 72.2 ± 27.4 | 21.6 (17.2 to 25.9) | <0.001 | 54.0 ± 31.3 | 5.6 (1.8 to 9.3) | 0.004 |
| 12 months | 69.8 ± 28.6 | 19.0 (14.6 to 23.5) | <0.001 | 57.2 ± 31.9 | 6.6 (2.1 to 11.1) | 0.005 |
| 24 months | 68.5 ± 30.3 | 20.4 (13.8 to 27.1) | <0.001 | 58.0 ± 31.9 | 6.4 (−1.0 to 13.8) | 0.09 |
| SF-36 Physical Component Summary | ||||||
| Baseline | 33.0 ± 9.0 | 32.6 ± 9.9 | ||||
| 1 month | 39.2 ± 9.2 | 6.0 (5.0 to 7.1) | <0.001 | 33.6 ± 9.9 | 0.6 (−0.4 to 1.6) | 0.24 |
| 6 months | 38.9 ± 10.3 | 5.5 (4.2 to 6.8) | <0.001 | 34.2 ± 9.9 | 1.0 (−0.1 to 2.1) | 0.07 |
| 12 months | 38.7 ± 10.2 | 5.0 (3.6 to 6.4) | <0.001 | 34.6 ± 10.8 | 0.8 (−0.6 to 2.2) | 0.28 |
| 24 months | 38.1 ± 10.2 | 4.9 (3.1 to 6.8) | <0.001 | 34.1 ± 10.2 | 1.6 (−0.7 to 3.8) | 0.17 |
| SF-36 Mental Component Summary | ||||||
| Baseline | 46.7 ± 12.7 | 45.4 ± 13.0 | ||||
| 1 month | 51.4 ± 11.5 | 4.2 (2.8 to 5.6) | <0.001 | 46.1 ± 13.4 | 0.4 (−1.0 to 1.9) | 0.56 |
| 6 months | 52.0 ± 10.3 | 4.6 (3.1 to 6.2) | <0.001 | 47.0 ± 12.9 | 1.1 (−0.3 to 2.4) | 0.13 |
| 12 months | 51.3 ± 10.8 | 4.3 (2.5 to 6.1) | <0.001 | 48.2 ± 13.8 | 1.9 (−0.0 to 3.8) | 0.055 |
| 24 months | 50.1 ± 12.6 | 4.2 (1.6 to 6.8) | 0.002 | 48.9 ± 11.7 | −0.5 (−3.3 to 2.2) | 0.69 |
TMVr, transcatheter mitral valve repair; KCCQ, Kansas City Cardiomyopathy Questionnaire; SF, Medical Outcomes Study Short Form