Table 4. Selected functional parameters over time. To enable paired comparisons, we restricted analysis to patients with data at all three visits.
| Characteristics | N | n (%), mean (SD) or median (IQR) | p-value | |||||
| Baseline | 1 month | 1 year | Baseline vs 1 month | Baseline vs 1 year | 1 year vs 1 month | |||
| MR grade | 0 | 36 | 0 (0.0%) | 4 (11.1%) | 3 (8.3%) | <0.0001 | <0.0001 | 0.2975 |
| 1 | 36 | 0 (0.0%) | 15 (41.7%) | 20 (55.6%) | ||||
| 2 | 36 | 12 (33.3%) | 12 (33.3%) | 10 (27.8%) | ||||
| 3 | 36 | 12 (33.3%) | 5 (13.9%) | 3 (8.3%) | ||||
| 4 | 36 | 12 (33.3%) | 0 (0.0%) | 0 (0.0%) | ||||
| AP annulus diameter, mm | 35 | 41.4 (4.3) | 36.0 (4.7) | 35.3 (5.2) | <0.0001 | <0.0001 | 0.4121 | |
| Regurgitant volume* | 26 | 44.8 (15.3) | 23.2 (12.0) | 25.6 (10.8) | <0.0001 | <0.0001 | 0.2984 | |
| Effective orifice area, mm2 | 16 | 26.9 (10.4) | 13.9 (6.0) | 17.6 (7.1) | 0.0001 | 0.0034 | 0.0506 | |
| Vena contracta#, mm | 28 | 6.0 (5.0-8.0) | 4.0 (1.8-5.0) | 3.5 (3.0-5.0) | <0.0001 | 0.0001 | 0.6376 | |
| LVESVi, ml/m2 | 35 | 65.7 (25.1) | 62.5 (22.1) | 57.1 (22.0) | 0.1369 | 0.0102 | 0.0137 | |
| LVESV, ml | 35 | 125.8 (51.4) | 119.3 (44.5) | 110.4 (47.7) | 0.1122 | 0.0206 | 0.0482 | |
| LVEDVi, ml/m² | 35 | 107.9 (27.1) | 101.1 (23.2) | 92.9 (27.5) | 0.0086 | 0.0013 | 0.0203 | |
| LVEDV, ml | 35 | 206.3 (61.0) | 192.1 (50.4) | 179.0 (63.0) | 0.0043 | 0.0024 | 0.0564 | |
| LAVi, ml/m2 | 32 | 62.1 (21.9) | 50.9 (17.7) | 48.9 (20.3) | 0.0001 | 0.0004 | 0.4122 | |
| Left atrium volume, ml | 32 | 118.3 (47.3) | 96.4 (36.6) | 93.2 (42.9) | 0.0001 | 0.0003 | 0.4591 | |
| LVEDD, mm | 35 | 63.9 (8.0) | 62.4 (8.1) | 62.0 (8.9) | 0.0563 | 0.0718 | 0.6125 | |
| LVESD, mm | 33 | 55.2 (8.5) | 53.5 (9.1) | 52.0 (9.3) | 0.1327 | 0.0052 | 0.1184 | |
| LVEF, % | 35 | 39.8 (9.1) | 40.0 (10.2) | 40.5 (9.7) | 0.7997 | 0.5946 | 0.6947 | |
| Tenting area, cm2 | 33 | 2.4 (0.9) | 1.8 (0.6) | 1.4 (0.7) | 0.0010 | <0.0001 | 0.0033 | |
| Tenting height, mm | 33 | 9.2 (3.0) | 7.9 (2.1) | 6.7 (1.8) | 0.0267 | <0.0001 | 0.0066 | |
| Tricuspid regurgitation | 0 | 35 | 1 (2.9%) | 3 (8.6%) | 7 (20.0%) | 0.0954 | 0.0008 | 0.0110 |
| 1 | 35 | 13 (37.1%) | 19 (54.3%) | 20 (57.1%) | ||||
| 2 | 35 | 19 (54.3%) | 9 (25.7%) | 6 (17.1%) | ||||
| 3 | 35 | 1 (2.9%) | 3 (8.6%) | 2 (5.7%) | ||||
| 4 | 35 | 1 (2.9%) | 1 (2.9%) | 0 (0.0%) | ||||
| NYHA Class | I | 36 | 0 (0.0%) | 5 (13.9%) | 8 (22.2%) | <0.0001 | <0.0001 | 0.1533 |
| II | 36 | 11 (30.6%) | 22 (61.1%) | 20 (55.6%) | ||||
| III | 36 | 22 (61.1%) | 9 (25.0%) | 8 (22.2%) | ||||
| IV | 36 | 3 (8.3%) | 0 (0.0%) | 0 (0.0%) | ||||
| EQ-5D visual analogue health status score (0-100) | 26 | 52.5 (50.0-70.0) | 75.0 (60.0-75.0) | 67.5 (60.0-75.0) | 0.0002 | 0.0116 | 0.6228 | |
| EQ5D-5L quality of life scale | 21 | 0.75 (0.71-0.86) | 0.86 (0.75-0.89) | 0.80 (0.70-0.88) | 0.0699 | 0.3094 | 0.5716 | |
| 6-minute walk test distance (metres) | 33 | 325.0 (240-411) | 390.0 (225-432) | 363 (220-450) | 0.0286 | 0.2014 | 0.3256 | |
| *Regurgitant volume was measured by the PISA method. Where no PISA measurement was available, we imputed estimated regurgitant volume by PISA using the measurement with the volume. #Where vena contracta was less than the lower limit of detection of 3 mm, we imputed 1.5 mm. | ||||||||