Table 3.
Procedural variables and outcomes of TF-TAVI
| Total (n=196) |
TAVI with BAV (n=56) |
TAVI without BAV (n=140) |
P value | |
| n/N (%) or Median (IQR) | n/N (%) or Median (IQR) | n/N (%) or Median (IQR) | ||
| Anaesthesia | 0.101 | |||
| General anaesthesia | 149/196 (76.0) | 47/56 (83.9) | 102/140 (72.9) | |
| Conscious sedation | 47/196 (24.0) | 9/56 (16.1) | 38/140 (27.1) | |
| Size of balloon used for predilation | n.a. | |||
| 20 mm | 16/196 (8.2) | 16/56 (28.6) | – | |
| 22/23 mm | 17/196 (8.7) | 17/56 (30.4) | – | |
| 24 mm | 2/196 (1.0) | 2/56 (3.6) | – | |
| 26 mm | 21/196 (10.7) | 21/56 (37.5) | – | |
| Size of implanted THV | 0.316 | |||
| 20 mm | 1/196 (0.5) | 1/56 (1.8) | 0/140 (0) | |
| 23 mm | 64/196 (32.7) | 20/56 (35.7) | 44/140 (31.4) | |
| 26 mm | 68/196 (34.7) | 13/56 (23.2) | 55/140 (39.3) | |
| 29 mm | 63/196 (32.1) | 22/56 (39.3) | 41/140 (29.3) | |
| Sizing vs native annulus | 0.779 | |||
| Undersized | 14/179 (7.8) | 3/55 (5.5) | 11/124 (8.9) | |
| Normal size | 121/179 (67.6) | 38/55 (69.1) | 83/124 (66.9) | |
| Oversized | 44/179 (24.6) | 14/55 (25.5) | 30/124 (24.2) | |
| Requirement for balloon postdilation | 39/196 (19.9) | 17/56 (30.4) | 22/140 (15.7) | 0.029 |
| Procedural duration (min) | 65 (47/104) | 90 (59/118) | 56 (40/87) | 0.001 |
| Fluoroscopy time (min) | 10.5 (8.0/14.0) | 13.0 (10.0/16.0) | 10.0 (7.0/12.0) | 0.001 |
| Contrast volume (ml) | 125 (100/175) | 131 (116/164) | 120 (98/190) | 0.240 |
| Device success*† | 189/196 (96.4) | 52/56 (92.9) | 137/140 (97.9) | 0.104 |
| Absence of death | 196/196 (100) | 56/56 (100) | 140/140 (100) | n.a. |
| Correct positioning | 195/196 (99.5) | 56/56 (100) | 139/140 (99.3) | 1.000 |
| Post-TAVI mean AV gradient ≤20 mm Hg | 190/196 (96.9) | 52/56 (92.9) | 138/140 (98.6) | 0.057 |
| Paravalvular leakage | 0.740 | |||
| Mild | 26/196 (13.3) | 8/56 (14.3) | 18/140 (12.9) | |
| Moderate/severe | 1/196 (0.5) | 0/56 (0) | 1/140 (0.7) | |
| Mean AV gradient (mm Hg) | 11.8±4.7 | 12.9±5.3 | 11.4±4.5 | 0.058 |
| Procedural complications | ||||
| Access complications‡ | 7/196 (3.6) | 0/56 (0) | 7/140 (5.0) | 0.195 |
| Aortic root rupture | 0/196 (0) | 0/56 (0) | 0/140 (0) | n.a. |
| Haemodynamic instability | 3/196 (1.5) | 2/56 (3.6) | 1/140 (0.7) | 0.197 |
| Catecholamine use | 2/196 (1.0) | 1/56 (1.8) | 1/140 (0.7) | 0.491 |
| Complete AV block with PPI | 5/196 (2.6) | 2/56 (3.6) | 3/140 (2.1) | 0.625 |
| Conversion to open surgery | 0/196 (0) | 0/56 (0) | 0/140 (0) | n.a. |
| Device malfunction | 0/196 (0) | 0/56 (0) | 0/140 (0) | n.a. |
| Need for second valve | 1/196 (0.5) | 0/56 (0) | 1/140 (0.7) | 1.000 |
*Defined according to VARC-2 as the absence of death, correct positioning of a single prosthetic heart valve and its intended performance.14
†Multiple reasons may apply.
‡Defined according to VARC-2 as dissection, aortic root rupture or uncontrolled bleeding.14
AV, aortic valve; BAV, balloon aortic valvuloplasty; n.a., not applicable; PPI, permanent pacemaker implantation; TAVI, transcatheter aortic valve implantation; THV, transcatheter heart valve; VARC-2, Valve Academic Research Consortium-2.