Table 4. Early clinical outcomes.
| Variable | Total (n=171) | CV group (n=87) | ES group (n=84) | P |
|---|---|---|---|---|
| In-hospital outcomes | ||||
| Stroke, n (%) | 3 (1.8) | 2 (2.3) | 1 (1.2) | 1 |
| Major vascular complication, n (%) | 14 (8.2) | 5 (5.8) | 9 (10.7) | 0.24 |
| Bleeding, n (%) | ||||
| Major | 30 (17.4) | 15 (17.2) | 15 (17.9) | 0.55 |
| Life-threatening | 9 (5.3) | 3 (3.5) | 6 (7.1) | |
| AKI, n (%) | ||||
| Stage 1 | 11 (6.4) | 9 (10.3) | 2 (2.4) | 0.07 |
| Stage 2 | 14 (8.2) | 4 (4.6) | 10 (11.9) | |
| Stage 3 | 11 (6.4) | 3 (6.9) | 5 (6.0) | |
| New PPM implantation, n (%) | 38 (22.3) | 33 (37.9) | 5 (5.9) | <0.001 |
| Thirty-day outcomes | ||||
| All-cause mortality, n (%) | 8 (4.7) | 5 (5.8) | 3 (3.6) | 0.72 |
| Cardiovascular mortality, n (%) | 7 (4.1) | 4 (4.6) | 3 (3.6) | 1 |
| All stroke, n (%) | 3 (1.8) | 2 (2.3) | 1 (1.2) | 1 |
| Myocardial infarction >72 h, n (%) | 5 (2.9) | 3 (3.5) | 2 (2.4) | 1 |
| Congestive heart failure, n (%) | 8 (4.7) | 6 (6.9) | 2 (2.4) | 0.28 |
| Early safety VARC 2†, n (%) | 130 (76.0) | 71 (81.6) | 59 (70.2) | 0.08 |
| Combined safety VARC 1‡, n (%) | 140 (81.9) | 73 (83.9) | 67 (79.8) | 0.48 |
| Major bleeding, n (%) | 33 (19.3) | 15 (17.2) | 18 (21.4) | 0.49 |
| Minor bleeding, n (%) | 18 (10.5) | 8 (9.2) | 10 (11.9) | 0.56 |
| New PPM implantation, n (%) | 42 (24.5) | 35 (40.2) | 7 (8.3) | <0.001 |
Data are expressed as absolute values and percentages. †, early safety VARC 2 was a composite of all-cause mortality, all stroke (disabling and non-disabling), life-threatening bleeding, AKI stage 2 or 3 (including renal replacement therapy), coronary artery obstruction requiring intervention, major vascular complication, valve-related dysfunction requiring repeat procedure. ‡, combined safety VARC 1 was a composite of all-cause mortality, major stroke, life-threatening (or disabling) bleeding, AKI stage 3 (including renal replacement therapy), peri-procedural myocardial infarction, major vascular complication, repeat procedure for valve-related dysfunction. AKI, acute kidney injury; PPM, permanent pacemaker.