Table 3.
Complications in patients undergoing Watchman implantation stratified on the basis of having pericardial effusion requiring intervention vs not
| Variable | Pericardial effusion requiring intervention (n = 220) | No pericardial effusion requiring intervention (n = 17,480) | P |
|---|---|---|---|
| Other complications | 85 (38.6) | 1625 (9.3) | <.001 |
| Major complications* | 25 (11.4) | 1085 (6.2) | <.001 |
| Cardiovascular complications | |||
| Any cardiovascular complication | 55 (25.0) | 365 (2.1) | <.001 |
| Percutaneous coronary intervention | <10 (<4) | 25 (0.1) | <.001 |
| Cardiac arrest | <10 (<4) | <10 (<0.2) | <.001 |
| Heart block | 0 (0.0) | 190 (1.1) | .180 |
| ST-segment elevation myocardial infarction | <10 (<2.3) | 20 (0.1) | <.001 |
| Non–ST-segment elevation myocardial infarction | <10 (<2.3) | 60 (0.3) | .001 |
| Cardiogenic shock | 25 (11.4) | 40 (0.2) | <.001 |
| Systemic complications | |||
| Any systemic complication | 0 (0.0) | 40 (0.2) | >.99 |
| Anaphylaxis | 0 (0.0) | <10 (0.0) | >.99 |
| Arterial embolism | 0 (0.0) | 25 (0.1) | >.99 |
| Septic shock | 0 (0.0) | <10 (0.1) | >.99 |
| Vascular complications | |||
| Any peripheral vascular complication | <10 (<2.3) | 190 (1.1) | .094 |
| AV fistula | 0 (0.0) | 25 (0.1) | >.99 |
| Pseudoaneurysm | 0 (0.0) | 60 (0.3) | >.99 |
| Access site hematoma | 0 (0.0) | 40 (0.2) | >.99 |
| Retroperitoneal bleeding | 0 (0.0) | 30 (0.2) | >.99 |
| Venous thromboembolism | <10 (<2.3) | 45 (0.3) | <.001 |
| Neurological complications | |||
| Any neurological complication | 0 (0.0) | 250 (1.4) | .080 |
| Hemorrhagic stroke | 0 (0.0) | 70 (0.4) | >.99 |
| Ischemic stroke | 0 (0.0) | 140 (0.8) | .425 |
| Transient ischemic attack | 0 (0.0) | 40 (0.2) | >.99 |
| Pulmonary complications | |||
| Any pulmonary complications | 45 (20.5) | 500 (2.9) | <.001 |
| Respiratory failure | 25 (11.4) | 295 (1.7) | <.001 |
| Pneumothorax | 15 (6.8) | 80 (0.5) | <.001 |
| Pleural effusion | 0 (0.0) | 90 (0.5) | .632 |
| Pneumonia | <10 (<4) | 75 (0.4) | <.001 |
| Need for a prolonged ventilator (>36 h) | 20 (9.1) | 135 (0.8) | <.001 |
Values are presented as n (%).
For N < 10, the absolute numbers are not reported as per Healthcare Cost and Utilization Project recommendations.
AV = atrioventricular.
*
Defined as composite of cardiac arrest, myocardial infarction, ischemic stroke, hemorrhagic stroke, transient ischemic attack, major bleeding, and vascular complication.