Table 3. Complications Reported at Day 5 Visit and at Month 1 Visit.
| Type of complication | Patients at day 5 visit, No. (%)a | P value | Patients at month 1 visit, No. (%)b | P value | ||||
|---|---|---|---|---|---|---|---|---|
| Total (N = 130) | pSAE (n = 65) | SURV (n = 65) | Total (N = 122) | pSAE (n = 59) | SURV (n = 63) | |||
| Need for splenic embolization | 20 (15.4) | 1 (1.5) | 19 (29.2) | <.001 | 4 (3.3) | 1 (1.7) | 3 (4.8) | .62 |
| Due to SAE procedure | ||||||||
| Hematoma on femoral access | 1 (0.8) | 1 (1.5) | 0 | >.99 | 1 (1.3)c | 1 (1.7) | 0d | >.99 |
| Thrombosis on femoral access | 1 (0.8) | 1 (1.5) | 0 | >.99 | 0c | 0 | 0d | NA |
| Aneurysm on femoral access | 1 (0.8) | 1 (1.5) | 0 | >.99 | 1 (1.3)c | 1 (1.7) | 0d | >.99 |
| Allergy to contrast agent | 0 | 0 | 0 | NA | 0 | 0 | 0 | NA |
| Kidney insufficiency | 0 | 0 | 0 | NA | 0 | 0 | 0 | NA |
| Splenic | ||||||||
| Abscess | 0 | 0 | 0 | NA | 0 | 0 | 0 | NA |
| Splenectomy | 3 (2.3) | 0 | 3 (4.6) | .12 | 1 (0.8) | 0 | 1 (1.6) | .52 |
| Arteriovenous fistula | 2 (1.5) | 0 | 2 (3.1) | .50 | 2 (1.6) | 1 (1.7) | 1 (1.6) | >.99 |
| Pseudoaneurysm | 9 (6.9) | 1 (1.5) | 8 (12.3) | .03 | 3 (2.5) | 0 | 3 (4.8) | .25 |
| Pseudocyst | 1 (0.8) | 1 (1.5) | 0 | >.99 | 1 (0.8) | 0 | 1 (1.6) | >.99 |
| Hemorrhagic | ||||||||
| Decrease in hemoglobin >3 g/dL with an identified bleeding site or a decrease in hemoglobin >4 g/dL without an identified bleeding site | 18 (13.8) | 7 (10.8) | 11 (16.9) | .31 | 3 (2.5) | 0 | 3 (4.8) | .25 |
| Transfusion | 15 (11.5) | 7 (10.8) | 8 (12.3) | >.99 | 2 (1.6) | 0 | 2 (3.2) | .50 |
| No. of packed RBC units transfused, median (IQR) | 2 (2-4) | 2 (1-3) | 2 (2-5) | .13 | 5 (4-6) | 0 | 5 (4-6) | NA |
| Infectious | ||||||||
| ≥1 Infectious complications | 4 (3.1) | 3 (4.6) | 1 (1.5) | .62 | 4 (3.3) | 1 (1.7) | 3 (4.8) | .62 |
| Septicemia | 1 (0.8) | 1 (1.5) | 0 | >.99 | 2 (1.6) | 0 | 2 (3.2) | .50 |
| Pancreatic | ||||||||
| Pancreatitis | 0 | 0 | 0 | NA | 2 (1.6) | 0 | 2 (3.2) | .50 |
| Thrombotic | ||||||||
| Thrombosis of splenoportal trunk | 1 (0.8) | 0 | 1 (1.5) | >.99 | 0 | 0 | 0 | NA |
| Phlebitis | 0 | 0 | 0 | NA | 1 (0.8) | 0 | 1 (1.6) | NA |
| Pulmonary embolism | 2 (1.5) | 1 (1.5) | 1 (1.5) | >.99 | 1 (0.8) | 0 | 1 (1.6) | NA |
| Pulmonary | ||||||||
| Pleural effusion | 11 (8.5) | 5 (7.7) | 6 (9.2) | .75 | 4 (3.3) | 2 (3.4) | 2 (3.2) | >.99 |
| Thoracic drain if pleural effusion | 5 (3.8) | 2 (3.1) | 3 (4.6) | >.99 | 1 (0.8) | 0 | 1 (1.6) | >.99 |
| Pulmonary infection | 5 (3.8) | 4 (6.2) | 1 (1.5) | .37 | 2 (1.6) | 1 (1.7) | 1 (1.6) | >.99 |
| ≥1 Complications (all) | 46 (35.4) | 19 (29.2) | 27 (41.5) | .14 | 23 (18.9) | 11 (18.6) | 12 (19.0) | .96 |
Abbreviations: IQR, interquartile range; NA, not applicable; pSAE, prophylactic splenic arterial embolization; RBC, red blood cell; SAE, splenic arterial embolization; SURV, surveillance, with embolization only if necessary.
SI conversion factor: To convert hemoglobin to grams per liter, multiply by 10.0.
a
Events occurring between day 0 and day 5 visits (where the day 5 visit occurred between day 4 and day 8 after inclusion).
b
Events occurring between day 5 visit and month 1 visit.
c
For 79 patients.
d
For 20 patients.