Table 4.
Effect of BAV omission on outcomes at 30 days
| TAVI without BAV | TAVI with BAV | OR (95% CI) | OR (95% CI) | ||
| (n=196) | (n=140) | (n=56) | Unadjusted | Adjusted* | |
| n/N (%) | n/N (%) | ||||
| Primary safety composite endpoint† | 18/196 (9.2) | 13/140 (9.3) | 5/56 (8.9) | 1.04 (0.34 to 3.39) | 2.55 (0.56 to 18.84) |
| All-cause mortality | 2/196 (1.0) | 2/140 (1.4) | 0/56 (0) | n.a. | n.a. |
| Non-fatal stroke | 0/194 (0) | 0/138 (0) | 0/56 (0) | n.a. | n.a. |
| Non-fatal MI | 1/194 (0.5) | 1/138 (0.7) | 0/56 (0) | n.a. | n.a. |
| AKI stage II/III ‡ | 3/195 (1.5) | 3/139 (2.2) | 0/56 (0) | n.a. | n.a. |
| Requiring dialysis § | 1/195 (0.5) | 1/139 (0.7) | 0/56 (0) | n.a. | n.a. |
| New PPI | 15/195 (7.7) | 10/139 (7.2) | 5/56 (8.9) | 0.79 (0.27 to 2.64) | 1.92 (0.39 to 14.80) |
| Life-threatening bleeding | 3/195 (1.5) | 2/139 (1.4) | 1/56 (1.8) | 0.80 (0.08 to 17.48) | <0.01 (<0.01 ->100) |
| Major vascular complications | 14/195 (7.2) | 8/139 (5.8) | 6/56 (10.7) | 0.51 (0.17 to 1.61) | 0.20 (0.03 to 1.03) |
| Valve-related or HF-related hospitalisation | 2/194 (1.0) | 1/138 (0.7) | 1/56 (1.8) | 0.40 (0.02 to 10.27) | n.a. |
| Valve-related dysfunction | 0/194 (0) | 0/138 (0) | 0/56 (0) | n.a. | n.a. |
| Moderate/severe PVL | 1/196 (0.5) | 1/140 (0.7) | 0/56 (0) | n.a. | n.a. |
| CCS angina class III/IV | 0/178 (0) | 0/125 (0) | 0/53 (0) | n.a. | n.a. |
| NYHA class III/IV | 14/192 (7.3) | 11/136 (8.1) | 3/56 (5.4) | 1.56 (0.46 to 7.08) | 3.02 (0.52 to 28.35) |
*Adjusted for baseline characteristics listed in table 1, including age, gender, prior myocardial infarction, prior stroke/transient ischaemic attack, serum creatinine ≥2.0 mg/dL, left ventricular ejection fraction and NYHA class.
†Defined according to Valve Academic Research Consortium-2 as a composite of all-cause mortality, non-fatal stroke, non-fatal myocardial infarction, acute kidney injury and permanent pacemaker implantation.14
‡According to AKIN criteria.
§Excluding patients with dialysis prior to TAVI.
AKI, acute kidney injury; BAV, balloon aortic valvuloplasty; CCS, Canadian Cardiovascular Society; HF, heart failure; MI, myocardial infarction; NYHA, New York Heart Association; PPI, permanent pacemaker implantation; TAVI, transcatheter aortic valve implantation.