Table 2.
Watchman Procedure-Related Complications Stratified by Race/Ethnic Groups
| Variables, n (%) | White (n=30 075) | Black (n=1480) | Hispanics (n=2090) | Other races (n=1315) | P value |
|---|---|---|---|---|---|
| Overall complications | 2975 (9.9) | 225 (15.2) | 260 (12.4) | 185 (14.1) | <0.01 |
| Major complications* | 1495 (5) | 105 (7.1) | 135 (6.5) | 115 (8.7) | <0.01 |
| Any cardiovascular complication† | 1790 (6) | 105 (7) | 120 (5.6) | 90 (7) | 0.02 |
| Any systemic complication‡ | 55 (0.2) | 0 | 0 | 0 | 0.03 |
| Any peripheral vascular complication§ | 390 (1.3) | 40 (2.7) | 40 (1.8) | 20 (1.6) | <0.01 |
| Any neurological complication∥ | 260 (0.9) | <11 (<0.3) | <11 (<0.2) | <11 (<0.4) | 0.25 |
| Any bleeding complication¶ | 1245 (4.2) | 100 (6.8) | 135 (6.4) | 75 (5.7) | <0.01 |
| Any pulmonary complication# | 805 (2.6) | 50 (3.3) | 60 (2.8) | 25 (2) | <0.01 |
For n <11, the absolute numbers are not reported as per the Healthcare Cost and Utilization Project recommendations. PCI indicates percutaneous coronary intervention.
Defined as a composite of pericardial effusion requiring intervention, cardiac arrest, ischemic stroke/transient ischemic attack, hemorrhagic stroke, systemic embolism, myocardial infarction, major bleeding, and peripheral vascular complications (arteriovenous fistula, pseudoaneurysm, access site hematoma, retroperitoneal bleeding, and venous thromboembolism).
Any cardiovascular complication constitutes cardiac arrest, heart block, ST and non–ST-segment–elevation myocardial infarction, PCI, pericardial effusion requiring intervention, cardiac tamponade, pericarditis, and cardiogenic shock.
Any systemic complication constitutes anaphylaxis, arterial thrombosis, and septic shock.
Any peripheral vascular complication constitutes arteriovenous fistula, pseudoaneurysm, hematoma, retroperitoneal bleeding, and venous thromboembolism.
Any neurological complication constitutes transient ischemic attack, ischemic, and hemorrhagic stroke.
Any bleeding complication constitutes gastrointestinal bleeding and need for blood transfusion.
Any pulmonary complication constitutes respiratory failure, pneumothorax, pleural effusion, pneumonia, and prolonged ventilator support (>36 h).