|
At 1 year
|
All-cause death
|
154 (10.5)
|
76 (12.2)
|
24 (11.8)
|
1.20 (0.91-1.58)
|
0.198
|
1.16 (0.75-1.78)
|
0.509
|
|
Cardiovascular death
|
94 (6.5)
|
51 (8.4)
|
16 (8.1)
|
1.33 (0.94-1.87)
|
0.106
|
1.29 (0.76-2.19)
|
0.352
|
|
Structural valve deterioration
|
23 (1.7)
|
10 (1.7)
|
5 (2.5)
|
1.02 (0.49-2.15)
|
0.956
|
1.54 (0.58-4.05)
|
0.384
|
|
Repeat aortic valve intervention
|
11 (0.7)
|
5 (0.8)
|
4 (1.9)
|
1.07 (0.37-3.08)
|
0.90
|
2.52 (0.80-7.94)
|
0.114
|
|
At 5 years
|
All-cause death
|
413 (52.8)
|
178 (58.3)
|
58 (51.5)
|
1.17 (0.98-1.39)
|
0.085
|
1.07 (0.81-1.41)
|
0.631
|
|
Cardiovascular death
|
275 (40.0)
|
128 (46.9)
|
40 (39.7)
|
1.26 (1.02-1.56)
|
0.029
|
1.13 (0.81-1.58)
|
0.473
|
|
Structural valve deterioration
|
30 (4.6)
|
15 (6.2)
|
9 (11.4)
|
1.37 (0.74-2.55)
|
0.319
|
1.92 (0.91-4.05)
|
0.088
|
|
Repeat aortic valve intervention
|
15 (2.3)
|
6 (2.5)
|
5 (5.8)
|
1.12 (0.43-2.89)
|
0.818
|
2.11 (0.76-5.83)
|
0.149
|
|
At 10 years
|
All-cause death
|
493 (84.3)
|
204 (89.7)
|
67 (94.6)
|
1.17 (1.00-1.38)
|
0.055
|
1.19 (0.92-1.54)
|
0.187
|
|
Cardiovascular death
|
344 (77.2)
|
148 (82.7)
|
48 (92.7)
|
1.25 (1.03-1.52)
|
0.023
|
1.26 (0.93-1.71)
|
0.131
|
|
Structural valve deterioration
|
34 (8.2)
|
16 (8.3)
|
9 (9.3)
|
1.17 (0.64-2.12)
|
0.614
|
1.89 (0.90-3.96)
|
0.091
|
|
Repeat aortic valve intervention
|
17 (3.8)
|
7 (11.3)
|
5 (3.8)
|
0.99 (0.41-2.41)
|
0.985
|
2.09 (0.77-5.70)
|
0.149
|
|
Predicted PPMTHV
|
|
|
None
|
Moderate
|
Severe
|
Moderate vs none
|
Severe vs none
|
|
|
(N=2,155)
|
(N=279)
|
(N=29)
|
Adjusted HR (95% CI)
|
p-value
|
Adjusted HR (95% CI)
|
p-value
|
|
At 1 year
|
All-cause death
|
237 (11.8)
|
15 (5.9)
|
2 (7.9)
|
0.53 (0.32-0.90)
|
0.019
|
0.57 (0.14-2.28)
|
0.422
|
|
Cardiovascular death
|
149 (7.5)
|
10 (4.0)
|
2 (7.9)
|
0.58 (0.30-1.10)
|
0.094
|
0.92 (0.23-3.73)
|
0.910
|
|
Structural valve deterioration
|
33 (1.7)
|
5 (2.0)
|
0
|
1.13 (0.44-2.91)
|
0.800
|
-
|
-
|
|
Repeat aortic valve intervention
|
15 (0.7)
|
5 (1.9)
|
0
|
2.34 (0.85-6.46)
|
0.101
|
-
|
-
|
|
At 5 years
|
All-cause death
|
600 (49.5)
|
44 (38.8)
|
5 (33.0)
|
0.68 (0.50-0.92)
|
0.013
|
0.58 (0.24-1.41)
|
0.231
|
|
Cardiovascular death
|
407 (38.0)
|
32 (30.6)
|
4 (24.6)
|
0.72 (0.50-1.03)
|
0.073
|
0.68 (0.25-1.81)
|
0.438
|
|
Structural valve deterioration
|
48 (4.1)
|
6 (3.2)
|
0
|
1.00 (0.43-2.35)
|
0.994
|
-
|
-
|
|
Repeat aortic valve intervention
|
19 (1.4)
|
7 (5.0)
|
0
|
2.77 (1.16-6.63)
|
0.022
|
-
|
-
|
|
At 10 years
|
All-cause death
|
702 (86.8)
|
56 (82.0)
|
6 (66.5)
|
0.73 (0.55-0.96)
|
0.022
|
0.54 (0.24-1.22)
|
0.139
|
|
Cardiovascular death
|
494 (80.3)
|
41 (72.8)
|
5 (62.3)
|
0.74 (0.54-1.03)
|
0.071
|
0.62 (0.26-1.49)
|
0.284
|
|
Structural valve deterioration
|
52 (8.5)
|
7 (9.6)
|
0
|
1.07 (0.48-2.36)
|
0.870
|
-
|
-
|
|
Repeat aortic valve intervention
|
20 (3.6)
|
9 (20.6)
|
0
|
3.41 (1.55-7.52)
|
0.002
|
-
|
-
|
|
Data are event counts with Kaplan-Meier failure rates (%) counting only the first event of each type per patient. Patients were censored at last valid contact with events assessed and adjudicated. Adjusted hazard ratios and p-values after adjusting for age, gender and STS-PROM. CI: confidence interval; HR: hazard ratio; PPM: prosthesis-patient mismatch; PPMTHV: prosthesis-patient mismatch defined by the normal reference values of effective orifice area for each size and model of implanted transcatheter heart valve; STS-PROM: Society of Thoracic Surgeons Predicted Risk of Mortality; THV: transcatheter heart valve
|
