Table 3. Procedure characteristics and outcomes by ARC-HBR status.
| HBR+ N=633 | HBR– N=154 | p-value | ||
|---|---|---|---|---|
| Procedure performed | 620/633 (97.9%) | 151/154 (98.1%) | >0.99 | |
| Total procedure time (min) | 72±36 | 77±37 | 0.18 | |
| Total contrast volume administered (mL) | 132±53 | 135±70 | 0.51 | |
| General anaesthesia | 88/620 (14.2%) | 28/151 (18.5%) | 0.20 | |
| Type of access | Percutaneous | 616/619 (99.5%) | 151/151 (100.0%) | 0.39 |
| Surgical cut-down | 3/619 (0.5%) | 0/151 (0.0%) | ||
| Sheathless | 235/620 (37.9%) | 52/151 (34.4%) | 0.45 | |
| Suture device closure for main access site | No | 5/619 (0.8%) | 1/151 (0.7%) | 0.92 |
| ProStar | 131/619 (21.2%) | 29/151 (19.2%) | ||
| 1 ProGlide | 34/619 (5.5%) | 7/151 (4.6%) | ||
| 2 ProGlide | 335/619 (54.1%) | 88/151 (58.3%) | ||
| Other | 114/619 (18.4%) | 26/151 (17.2%) | ||
| Predilatation balloon valvuloplasty | 370/620 (59.7%) | 93/151 (61.6%) | 0.71 | |
| Size device (mm) | 27±2 | 26±2 | 0.08 | |
| Post-dilatation | 248/620 (40.0%) | 68/151 (45.0%) | 0.27 | |
| Procedural complications | 84/620 (13.5%) | 28/151 (13.2%) | >0.99 | |
| Valve malpositioning | 5/620 (0.8%) | 6/151 (4.0%) | 0.01 | |
| Coronary artery obstruction | 2/620 (0.3%) | 0/151 (0.0%) | >0.99 | |
| Haemodynamic instability | 9/620 (1.5%) | 0/151 (0.0%) | 0.21 | |
| Cardiac tamponade | 7/620 (1.1%) | 1/151 (0.7%) | >0.99 | |
| Annular rupture | 1/620 (0.2%) | 1/151 (0.7%) | 0.35 | |
| Conversion to open heart surgery | 2/620 (0.3%) | 0/151 (0.0%) | >0.99 | |
| Access vessel complication | 48/620 (7.7%) | 9/151 (6.0%) | 0.60 | |
| Bleeding | 16/620 (2.6%) | 1/151 (0.7%) | 0.22 | |
| Intraprocedural death | 3/620 (0.5%) | 0/151 (0.0%) | >0.99 | |
| Number of events (percentages). ARC-HBR: Academic Research Consortium - High Bleeding Risk; min: minutes; mL: millilitres; mm: millimetres | ||||