Table 5.
Effect of BAV omission on outcomes at 6 months
| Total | TAVI without BAV | TAVI with BAV | OR (95% CI) | OR (95% CI) | |
| (n=196) | (n=140) | (n=56) | Unadjusted | Adjusted* | |
| n/N (%) | n/N (%) | n/N (%) | |||
| Secondary safety composite endpoint† | 30/193 (15.5) | 21/138 (15.2) | 9/55 (16.4) | 0.92 (0.40 to 2.24) | 1.66 (0.49 to 6.55) |
| All-cause mortality | 9/191 (4.7) | 6/138 (4.4) | 3/53 (5.7) | 0.76 (0.19 to 3.70) | 1.81 (0.03 –>100) |
| Cardiac | 2/191 (1.0) | 1/138 (0.7) | 1/53 (1.9) | – | – |
| Non-cardiac | 3/191 (1.6) | 3/138 (2.2) | 0/53 (0) | – | – |
| Unknown | 4/191 (2.1) | 2/138 (1.4) | 2/53 (3.8) | – | . |
| Non-fatal stroke | 2/184 (1.1) | 2/134 (1.5) | 0/50 (0) | n.a. | n.a. |
| Non-fatal MI | 1/184 (0.5) | 1/134 (0.7) | 0/50 (0) | n.a. | n.a. |
| New PPI | 19/188 (10.1) | 12/135 (8.9) | 7/53 (13.2) | 0.64 (0.24 to 1.82) | 1.60 (0.39 to 8.43) |
| Valve thrombosis requiring medication | 2/185 (1.1) | 2/134 (1.5) | 0/51 (0) | n.a. | n.a. |
| Endocarditis | 1/185 (0.5) | 0/134 (0) | 1/51 (2.0) | n.a. | n.a. |
| Valve-related or HF-related hospitalisation | 8/184 (4.3) | 5/134 (3.7) | 3/50 (6.0) | 0.61 (0.14 to 3.05) | 0.14 (0.01 to 1.22) |
| NYHA class III/IV | 13/183 (7.1) | 11/134 (8.2) | 2/49 (4.1) | 2.10 (0.54 to 13.91) | 1.24 (0.21 to 11.17) |
*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 as per the Valve Academic Research Consortium-2 early safety composite (combined rate of all-cause mortality, non-fatal stroke, non-fatal myocardial infarction, acute kidney injury and/or permanent pacemaker implantation).14
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.