Table 2.
Procedural data, short and mid-term outcomes.
| Procedural Characteristics | |
| Prosthesis Size: S M L |
1 (4.1%) 11 (45.9%) 12 (50%) |
| Oversizing, % | 10.9 (5–20%) |
| Procedure Time, min § | 59.9 (20–100) |
| Contrast Volume, ml § | 150 (30–330) |
| Fluoroscopy Time, min § | 19.9 (5–60) |
| Pre Implant BAV | 3 (12.5%) |
| Post Dilatation | 4 (16.6%) |
| Rapid Pacing | 5 (20.8%) |
| Successful Valve Deployment | 21 (87.5%) |
| Valve Migration | 2 (8.3%) |
| Implantation of a second valve | 3 (12.5%) |
| Conversion to Surgery | 0 (0.0%) |
| Coronary Obstruction | 0 (0.0%) |
| Cardiac Tamponade | 0 (0.0%) |
| Moderate/severe PVL | 1 (4.1%) |
| Device Success | 21 (87.5%) |
| In-hospital outcomes | |
| Death | 1 (4.1%) |
| Myocardial Infarction | 0 (0.0%) |
| Stroke (disabling and non-disabling) | 0 (0.0%) |
| Reintervention on aortic valve | 0 (0.0%) |
| Vascular Complications: Major Minor |
1 (4.1%) 3 (12.5%) |
| Bleeding: Major Minor |
2 (8.3%) 5 (20.8%) |
| New Pacemaker Implantation | 4 (21.1%) |
| Acute Kidney Injury | 0 (0%) |
| Moderate/severe PVL | 2 (8.3%) |
| NYHA Class I II III |
7 (29.1%) 15 (62.5%) 2 (8.3%) |
| 30-day follow up | |
| All-cause death | 1 (4.1%) |
| Cardiovascular death | 1 (4.1%) |
| Rehospitalization for CHF | 1 (4.1%) |
| NYHA Class I II III |
7 (30.4%) 15 (65.2%) 1 (4.3%) |
| Moderate/severe PVL | 2 (8.3%) |
| Aortic valve area, cm2 § | 1.9 (1.2–2.2) |
| Mean Aortic Gradient, mmHg § | 6.5 (4–16) |
| Early Safety | 22 (91.6%) |
| 1-year follow up (n = 17) | |
| All-cause death | 2 (11.7%) |
| Cardiovascular death | 2 (11.7%) |
| Rehospitalization for CHF Clinical Efficacy |
2 (11.7%) 15 (88.8%) |
† Data are presented as mean ± standard deviation. § Data are expressed as median (min–max).
BAV = balloon aortic valvuloplasty; PVL = paravalvular leakage; CHF = congestive heart failure
Early safety (VARC-2): combined endpoint at 30 days including all-cause mortality, all stroke, life-threatening bleeding, acute kidney injury stage 2 or 3, coronary artery obstruction requiring intervention, major vascular complication and valve-related dysfunction requiring repeat procedure.
Clinical efficacy (VARC-2): combined endpoint after 30 days including all-cause mortality, disabling or non-disabling stroke, or hospitalizations for valve-related symptoms or worsening congestive heart failure