Introduction
Methods
Patient population
Echocardiography and multislice computed tomography (MSCT) data analysis
Prosthesis size selection and procedure
Definition of endpoints and follow-up
Statistical analysis
Results
Patient population and in-hospital outcome
Total patients (n = 402) | |
---|---|
Age (years) | 81 ± 6 |
Female gender | 173 (43) |
Logistic EuroSCORE I | 12 [8–19] |
EuroSCORE II | 4 [3–7] |
Society of thoracic surgeons score | 4.3 [2.7–6.6] |
New York Heart Association class III/IV | 248 (62) |
Chronic obstructive pulmonary disease | 58 (14) |
Diabetes mellitus | 124 (31) |
Glomerular filtration rate (ml/min) | 54 ± 22 |
Peripheral vascular disease | 53 (13) |
Previous stroke major/minor | 39 (10) |
Previous pacemaker | 41 (10) |
Previous myocardial infarction | 41 (10) |
Previous percutaneous coronary intervention | 170 (42) |
Previous coronary artery bypass graft | 24 (6) |
Echocardiographic characteristics | |
Left ventricular ejection fraction < 35% | 40 (10) |
Mean transaortic gradient (mmHg) | 44 ± 16 |
Pulmonary arterial pressure ≥ 60 mmHg | 34 (9) |
Total patients (n = 402) | |
---|---|
Procedural characteristics | |
Conscious sedation | 203 (51) |
Pre-dilatation | 392 (98) |
Post-dilatation | 154 (38) |
Procedural time (min) | 58 ± 29 |
Contrast (ml) | 118 ± 58 |
Fluoroscopy time (min) | 13 ± 6 |
Device successa | 374 (93) |
Procedural mortality | 2 (0.5) |
Correct position | 400 (99.5) |
Intended performanceb | 378 (94) |
PVL II + | 8 (2) |
Elevated gradient (≥ 20 mmHg) | 13 (3) |
Multiple valves | 4 (1) |
Conversion | 3 (0.7) |
In-hospital characteristics | |
Days on Intensive Care Unit | 1 [1–2] |
Days in hospital | 5 [4–6] |
ln-hospital mortality | 2 (0.5) |
All stroke | 8 (2) |
Major vascular complication | 31 (8) |
Life-threatening bleeding | 20 (5) |
Renal failure (AKIN 2/3, including dialysis) | 12 (3) |
Coronary artery obstruction w/PCI | 1 (0.2) |
Myocardial infarction | 1 (0.2) |
Clinical outcomes during 1 year after TAVI
30 days | 1 year | |||
---|---|---|---|---|
KM estimate (%) [95% CI] | Events (n) | KM estimate (%) [95% CI] | Events (n) | |
All-cause mortality | 0.8 [0.2–2.3] | 3 | 8.9 [6.4–12.2] | 34 |
Cardiac mortality | 0.75 [0.24–2.31] | 3 | 5.2 [3.66–8.40] | 21 |
All stroke | 2.0 [1.0–4.0] | 8 | 5.0 [3.2–7.8] | 19 |
Major vascular complication | 7.8 [5.5–10.9] | 31 | 8.3 [6.0-11.5] | 33 |
Life-threatening bleeding | 6.0 [4.1–8.8] | 24 | 9.0 [6.6–12.3] | 35 |
Renal failure (AKIN 2/3, including dialysis) | 3.0 [1.7–5.2] | 12 | 3.6 [2.1–5.9] | 14 |
Percutaneous coronary intervention | 0.3 [0.04–1.8] | 1 | 1.9 [0.9–3.9] | 7 |
Myocardial infarction | 0.3 [0.04–1.8] | 1 | 1.4 [0.6–3.2] | 5 |
New permanent pacemaker implantationa | 12.8 [9.8–16.7] | 46 | 16.2 [12.7–20.4] | 57 |
Valve-related dysfunction w/ BAV, TAVR or SAVR | 0 | 0 | 0.3 [0.04–1.9] | 1 |
Valve-related dysfunctionb | 5.4 [3.5–8.1] | 21 | 20.6 [15.3–27.5] | 52 |
Endocarditis | 0 | 0 | 1.9 [0.9-4.0] | 7 |
Congestive heart failure w/ hospitalization | 2.5 [1.4–4.6] | 10 | 12.0 [9.1–15.7] | 45 |
Early safety (at 30 days)b | 13.7 [10.7–17.4] | 55 | – | – |
Clinical efficacy (after 30 days)b | – | – | 37.2 [32.2–42.7] | 133 |
Time-related valve safetyb | 12.8 [9.9–16.5] | 51 | 29.4 [24.7–34.7] | 105 |