Table 1.
Incidence of procedure related complications, stratified by patient group
| Complications, n (%) | Cryoablation | PV isolation | LA ablation | LA + RA ablation | RA ablation |
|---|---|---|---|---|---|
| Group 1 (n = 5608), n (95% CI) (%) | Group 2 (n = 3167), n (95% CI) (%) | Group 3 (n = 8336), n (95% CI) (%) | Group 4 (n = 2403), n (95% CI) (%) | Group 5 (n = 13 871), n (95% CI) (%) | |
| In-hospital death* | 8 (3–17) (0.1) | 0 (0–5) (0.0) | 7 (3–16) (0.1) | 3 (0–10) (0.1) | 47 (34–64) (0.3) |
| Stroke* | 27 (18–40) (0.5) | 17 (10–28) (0.5) | 48 (35–65) (0.6) | 15 (8–26) (0.6) | 70 (54–89) (0.5) |
| Pneumonia* | 30 (20–44) (0.5) | 23 (14–36) (0.7) | 88 (71–109) (1.1) | 25 (16–38) (1.0) | 282 (250–317) (2.0) |
| Phrenic nerve injury* | 21 (13–33) (0.4) | n.a. | n.a. | n.a. | 8 (3–17) (0.1) |
| Cardiac arrest* | 13 (7–23) (0.2) | 3 (0–10) (0.1) | 17 (10–28) (0.2) | 7 (3–16) (0.3) | 49 (36–66) (0.4) |
| AV Block III°* | 11 (5–21) (0.2) | 9 (4–18) (0.3) | 29 (19–43) (0.3) | 8 (3–17) (0.3) | 223 (195–255) (1.6) |
| Pericardial effusion | 167 (143–195) (3.0) | 100 (81–122) (3.2) | 305 (272–341) (3.7) | 98 (80–120) (4.1) | 237 (208–270) (1.7) |
| Pericardial drainage* | 42 (29–55) (0.7) | 26 (16–36) (0.8) | 113 (92–134) (1.4) | 20 (11–29) (0.8) | 47 (34–60) (0.3) |
| Access site complications | 411 (373–452) (7.3) | 219 (192–250) (6.9) | 655 (607–706) (7.9) | 149 (127–175) (6.2) | 536 (492–583) (3.9) |
| Vascular intervention /surgery* | 15 (7–23) (0.3) | 15 (7–23) (0.5) | 97 (78–116) (1.2) | 12 (5–19) (0.5) | 80 (62–98) (0.6) |
| Transfusion* | 48 (34–62) (0.9) | 40 (28–52) (1.3) | 203 (175–231) (2.4) | 35 (23–47) (1.5) | 222 (193–251) (1.6) |
| Total, overall | 688 (637–739) (12.3) | 371 (333–409) (11.7) | 1149 (1083–1215) (13.8) | 305 (271–339) (12.7) | 1452 (1377–1527) (10.5) |
| Total, major | 215 (186–244) (3.8) | 133 (110–156) (4.2) | 602 (554–650) (7.2) | 125 (103–147) (5.2) | 1028 (965–1091) (7.4) |
Major complications are marked by an asterisk (*). Complications are presented as incident cases (percentage), stratified by pre-specified patient groups. Access site complications consist of bleeding, haematoma, shock, infection, and vascular complications. Detailed group definitions are provided in the methods section.
LA, left atrium; n.a., not assessed (indicates table cell with too few observations for display due to data protection policies); RA, right atrium.