Table 2.
Major and minor complications
| Full patient cohort from all 106 MANIFEST-17K sitesa (N = 17,642) | |
|---|---|
| Major AEs | 173 (0.98%) |
| Deathb | 5 (0.03%) |
| Stroke | 22 (0.12%) |
| Esophageal fistula or dysmotility | 0 (0%) |
| Pulmonary vein stenosis | 0 (0%) |
| Phrenic nerve injury (persistent)c | 0 (0%) |
| Pericardial tamponadeb | 63 (0.36%) |
| Percutaneous intervention | 56 (0.32%) |
| Surgical interventionb | 7 (0.04%) |
| Vascular complication (with intervention) | 53 (0.30%) |
| Coronary artery spasm | 25 (0.14%) |
| Myocardial infarction | 0 (0.0%) |
| Hemolysis renal failure (hospitalization) | 5 (0.03%) |
| Other (thrombosis) | 1 (0.006%) |
| Minor AEs | 567 (3.21%) |
| Transient ischemic attack | 21 (0.12%) |
| Phrenic nerve injury (transient)c | 11 (0.06%) |
| Pericardial effusion (no intervention) | 59 (0.33%) |
| Pericarditis | 30 (0.17%) |
| Vascular complications (no intervention) | 388 (2.20%) |
| Hemolysis renal failure (no hospitalization) | 1 (0.006%) |
| Other complications | 57 (0.32%) |
aThe initial 1,758 patients treated in 2021 (and previously reported in the MANIFEST-PF survey) are excluded from this analysis.
bOne patient requiring surgical intervention for tamponade subsequently died and is thus counted in both categories.
cPersistent injury is defined as being present after hospital discharge, while transient injury is defined as having recovered by the time of discharge.
Overall major and minor event rates have been highlighted in bold.