Background
Methods
Procedures and devices
Data collection and variables
Endpoints
Statistical analysis
Results
Patient characteristics
Without diabetes (n = 1337) | Diabetes on OAD (n = 387) | Diabetes on insulin (n = 276) | p-value | |
---|---|---|---|---|
Age (years) | 82.30 ± 5.51 | 81.35 ± 5.12 | 79.75 ± 5.49 | < 0.001 |
Male gender | 590 (44.1) | 182 (47.0) | 140(50.7) | 0.110 |
LVEF (%) | 57.57 ± 13.07 | 56.37 ± 13.77 | 53.85 ± 14.63 | 0.001 |
PAD | 187 (14.0) | 60 (15.5) | 71 (25.7) | 0.067 |
CAD | 767 (57.4) | 251 (64.9) | 199 (72.1) | < 0.001 |
Previous CABG | 173 (12.9) | 62 (16.0) | 68 (24.6) | < 0.001 |
Previous MI | 137 (10.2) | 49 (12.7) | 39 (14.1) | 0.110 |
COPD (moderate/severe) | 150 (11.2) | 52 (13.4) | 33 (12.0) | 0.488 |
Mitral valve disease (> II°) | 174 (13.0) | 48 (12.4) | 38 (13.8) | 0.875 |
Porcelain aorta | 88 (6.6) | 26 (6.7) | 14 (5.1) | 0.621 |
Log. EuroSCORE I | 20.46 ± 14.52 | 20.60 ± 15.12 | 24.69 ± 18.17 | < 0.001 |
Carotid stenosis | 231 (17.3) | 74 (19.1) | 64 (23.2) | 0.065 |
Previous valve surgery | 46 (3.4) | 14 (3.6) | 5 (1.8) | 0.344 |
Major neurological deficits | 128 (9.6) | 32 (8.3) | 40 (14.5) | 0.021 |
Critical perioperative situation | 19 (1.4) | 3 (0.8) | 6 (2.2) | 0.310 |
Pulmonary hypertension (moderate/severe) | 277 (20.7) | 68 (17.6) | 69 (25.0) | 1.0 |
Renal failure incl. dialysis | 53 (4.0) | 25 (6.5) | 30 (10.9) | < 0.001 |
Emergency case | 15 (1.1) | 7 (1.8) | 6 (2.2) | 0.157 |
Overall frailty | 412 (30.8) | 141 (36.4) | 114 (41.3) | 0.001 |
NYHA IV | 88 (6.6) | 27 (7.0) | 32 (11.6) | 0.014 |
Procedural characteristics
Periprocedural outcomes and early safety
Without diabetes (n = 1337) | Diabetes on OAD (n = 387) | Diabetes on insulin (n = 276) | p-value | HR (95% CI)* | p-value* | |
---|---|---|---|---|---|---|
Total mortality | 68 (5.1) | 17 (4.4) | 21 (7.6) | 0.255 | 1.05 (0.69–1.60) | 0.814 |
Cardiovascular death | 45 (3.4) | 15 (3.9) | 15 (5.4) | 0.212 | 0.91 (0.56–1.48) | 0.711 |
Noncardiovascular death | 23 (1.7) | 2 (0.5) | 6 (2.2) | 0.160 | 1.46 (0.64–3.36) | 0.369 |
Myocardial infarction | 14 (1.0) | 7 (1.8) | 4 (1.4) | 0.379 | 0.58 (0.26–1.33) | 0.201 |
Stroke | 78 (5.8) | 14 (3.6) | 13 (4.7) | 0.110 | 1.49 (0.94–2.35) | 0.088 |
Major/disabling stroke | 29 (2.2) | 8 (2.1) | 8 (2.9) | 0.731 | 0.94 (0.50–1.76) | 0.854 |
Minor stroke | 49 (3.7) | 6 (1.6) | 5 (1.8) | 0.046 | 2.19 (1.11–4.3) | 0.023 |
Bleeding | 254 (19.0) | 71 (18.3) | 58 (21.0) | 0.809 | 0.96 (0.75–1.22) | 0.735 |
Life-threatening or major | 127 (9.5) | 33 (8.5) | 31 (11.2) | 0.936 | 1.02 (0.73–1.46) | 0.927 |
Minor | 127 (9.5) | 38 (9.8) | 27 (9.8) | 0.872 | 0.91 (0.66–1.26) | 0.584 |
Renal complications | 302 (22.6) | 115 (29.7) | 101 (36.6) | < 0.001 | 1.46 (1.18–1.81) | < 0.001 |
Stage 2/3 | 36 (2.7) | 13 (3.4) | 13 (4.7) | 0.170 | 0.73 (0.43–1.24) | 0.248 |
Vascular complications | 123 (9.2) | 39 (10.1) | 22 (8.0) | 0.652 | 0.94 (0.67–1.31) | 0.713 |
Major | 39 (2.9) | 14 (3.6) | 12 (4.3) | 0.428 | 0.74 (0.44–1.24) | 0.255 |
Minor | 84 (6.3) | 25 (6.5) | 10 (3.6) | 0.211 | 1.09 (0.72–1.66) | 0.676 |
New PPM implantation | 175/1167 (15.0) | 45/340 (13.2) | 43/228 (18.9) | 0.180 | 0.96 (0.72–1.27) | 0.753 |
Without diabetes (n = 1337) | Diabetes on OAD (n = 387) | Diabetes on insulin (n = 276) | p-value | Adjusted OR (95% CI)† | Adjusted p-value† | |
---|---|---|---|---|---|---|
Device success (n, %) | 1196 (89.5) | 346 (89.4) | 245 (88.8) | 0.944 | 1.10 (0.64–1.91) | 0.731 |
Gradient ≥ 20 mmHg (n, %) | 39 (2.9) | 14 (3.6) | 7 (2.5) | 0.228 | 1.10 (0.64–1.91) | 0.731 |
Moderate or severe aortic insufficiency (n, %) | 19 (1.4) | 4 (1.0) | 3 (1.1) | 0.707 | 0.77 (0.32–1.87) | 0.564 |
Malposition (n, %) | 6 (0.4) | 0 | 6 (2.2) | 0.079 | 1.67 (0.52–5.35) | 0.391 |
Second Valve (n, %) | 44 (3.3) | 14 (3.6) | 7 (2.5) | 0.607 | 0.96 (0.56–1.65) | 0.881 |
Procedural mortality 72 h (n, %) | 23 (1.7) | 8 (2.1) | 9 (3.3) | 0.685 | 1.19 (0.62–2.27) | 0.598 |
Early safety (n, %) | 1165 (87.1) | 326 (84.2) | 234 (84.8) | 0.258 | 1.26 (0.96–1.66) | 0.096 |
Intermediate and long-term survival
1 year | 3 years | |||
---|---|---|---|---|
HR (95% CI) | p-value | HR (95% CI) | p-value | |
Male gender | 1.14 (0.90–1.45) | 0.274 | 0.90 (0.76–1.06) | 0.217 |
Age | 1.02 (1.002–1.04) | 0.031 | 1.03 (1.01–1.04) | < 0.001 |
Diabetes | ||||
Orally treated | 0.89 (0.67–1.19) | 0.452 | 0.99 (0.82–1.21) | 0.935 |
Insulin treated | 1.29 (0.97–1.72) | 0.084 | 1.21 (0.98–1.49) | 0.079 |
EF | 0.98 (0.98–0.99) | < 0.001 | 0.99 (0.99–1.0) | 0.001 |
PAD | 1.44 (1.10–1.90) | 0.008 | 1.32 (1.09–1.60) | 0.005 |
Carotid stenosis | 1.02 (0.77–1.35) | 0.904 | 0.99 (0.81–1.20) | 0.902 |
COPD | 1.37 (1.003–1.87) | 0.048 | 1.41 (1.14–1.74) | 0.002 |
Previous valve surgery | 1.13 (0.65–1.94) | 0.667 | 0.97 (0.65–1.46) | 0.898 |
Major neurological deficits | 1.08 (0.77–1.51) | 0.644 | 1.13 (0.89–1.43) | 0.302 |
Pulmonary hypertension | 1.42 (1.11–1.81) | 0.005 | 1.35 (1.13–1.61) | 0.001 |
Previous MI | 1.18 (0.86–1.60) | 0.308 | 1.08 (0.86–1.35) | 0.535 |
Previous CABG | 1.13 (0.83–1.55) | 0.439 | 1.40 (1.13–1.73) | 0.002 |
Mitral valve disease | 1.26 (0.95–1.68) | 0.104 | 1.07 (0.87–1.33) | 0.525 |
Frailty | 1.77 (1.41–2.23) | < 0.001 | 1.77 (1.51–2.08) | < 0.001 |
Chronic renal failure | 2.65 (1.89–3.73) | < 0.001 | 2.39 (1.85–3.09) | < 0.001 |
CAD | 0.99 (0.77–1.28) | 0.963 | 1.07 (0.90–1.29) | 0.397 |