Table 5.
Adverse events and serious adverse events by treatment group
| Adverse events | RIPC (n = 60) | Control (n = 60) |
|---|---|---|
| Cardiac complication∗ | 7 (12%) | 6 (10%) |
| Cardiac arrest | 0 | 1 (2%) |
| ECLS required† | 1 (2%) | 1 (2%) |
| Postoperative complete heart block | 1 (2%) | 1 (2%) |
| Reoperation required† | 4 (7%) | 4 (7%)‡ |
| Pericardial collection/bleeding | 2 (3%) | 1 (2%) |
| Residual lesions | 1 (2%) | 2 (3%) |
| Epicardial pacemaker fitted | 1 (2%) | 1 (2%) |
| Chest left open | 4 (7%) | 2 (3%) |
| Post-CPB bleeding | 1 (2%) | 0 |
| Prolonged CPB time | 3 (5%) | 1 (2%) |
| Other | 0 | 1 (2%) |
| Neurological event† | 0 | 0 |
| Renal support, CVVH or PD | 1 (2%) | 2 (3%) |
| Peak creatinine, μmol/L | 25 [20-31] | 24 [21-30] |
| Respiratory event | 2 (3%) | 2 (3%) |
| Reintubated | 0 | 1 (2%) |
| Infection – systemic | 4 (7%) | 1 (2%) |
| Infection – surgical site | 1 (2%) | 0 (0%) |
| Limb complication | 0 | 0 |
| Other adverse event | 0 | 0 |
| Death after surgery† | 0 | 0 |
Data are median [IQR] when appropriate. RIPC, Remote ischemic preconditioning; ECLS, extracorporeal life support; CPB, cardiopulmonary bypass; CVVH, continuous veno-venous hemofiltration; PD, peritoneal dialysis.
∗
Two participants experienced 3 adverse events each, and 2 participants experienced 2 adverse events each. In total, 19 adverse events occurred in 13 participants.
†
Serious adverse event requiring expedited reporting.
‡
One participant underwent 2 reoperations to fit a temporary then permanent epicardial pacemaker; in total, 5 reoperations occurred in 4 participants.