Introduction
Methods
Study design
Severity of AE | Clinical impact |
---|---|
1 | AE does not require treatment & has no adverse effect |
2 | AE requires minor invasive (e.g., Foley catheter, nasogastric tube) or simple treatment but has no long-term effect |
3 | AE requires invasive (e.g., surgery) or complex treatment (e.g., monitored bed) & is most likely to have a temporary (< 6 mos) adverse effect on outcome |
4 | AE requires invasive (e.g., surgery) or complex treatment (e.g., monitored bed) & is most likely to have a prolonged (> 6 mos) adverse effect on outcome* |
5 | Significant neural injury (i.e., 1 or more grade deterioration in ASIA grade) or serious life- or limb-threatening event or any sentinel event† |
6 | AE resulting in death |
Intraop AE category |
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1. Allergic reaction |
2. Anesthesia related |
3. Bone implant interface failure requiring revision |
4. Cardiac |
5. Cord injury |
6. Dural tear |
7. Hardware malposition requiring revision |
8. Hypotension (systemic < 85 mm Hg for 15 min) |
9. Massive blood loss (> 5 L in 24 h or > 2 L in 3 h) |
10. Nerve root injury |
11. Pressure sores |
12. Vascular injury |
13. Airway/ventilation |
14. Visceral injury |
15. Other (specify) |
Postop AE category | |
---|---|
1. Cardiac arrest/failure/arythmia | |
2. Construct failure with loss of correction | |
3. Construct failure without loss of correction | |
4. CSF leak/meningocele | |
5. Deep vein thrombosis | |
6. Deep wound infection | |
7. Delirium | |
8. Dysphagia | |
9. Dysphonia | |
10. Gastrointestinal bleeding | |
11. Hematoma | |
12. Myocardial infarction | |
13. Neurologic deterioration ≥ 1 motor grade in ASIA motor scale | |
14. Nonunion | |
15. Pneumonia | |
16. Postop neuropathic pain | |
17. Pressure sores | |
18. Pulmonary embolism | |
19. Superficial wound infection | |
20. Systemic infection | |
21. Urinary tract infection | |
22. Wound dehiscence | |
23. Other (specify:) | |
Estimated effect of AE on LOS | |
None | 8–14 days |
1–2 days | 15–28 days |
3–7 days | More than 28 days |
Statistical analysis
Results
AEs collected prospectively and retrospectively occurring in patients treated between January 2017 and January 2018
Demographics | |
---|---|
Total number of patients | 336 |
Female | 198 |
Male | 138 |
Mean age (years) | 60.3 |
Range (years) | 6–91 |
Non-oncological disease | |
---|---|
Number of patients | 223 |
Female | 149 |
Male | 74 |
Mean age (years) | 64,2 |
Range (years) | 13–91 |
Mean CCI Index | 2.4 (SD 1.7) |
Previous spine surgery | 67 (30%) |
Mean ASA score | 2.2 (SD 0.6) |
Oncological disease | |
---|---|
Number of patients | 113 |
Female | 49 |
Male | 64 |
Mean age (years) | 52.4 |
Range (years) | 6–83 |
Mean CCI Index | 4.7 (SD 3.2) |
Previous spine surgery | 42 (37%) |
Mean ASA score | 2.3 (SD 0.7) |
Intraoperative AEs
Early postoperative AEs
Late postoperative AEs
Elective versus emergency surgery
Non-complicated patient N | Complicated patient N | Total patient N | p value | Intraoperative AEs N | Early postoperative AE N | Late postoperative AEs N | Total AEs N | p value | |
---|---|---|---|---|---|---|---|---|---|
Non-oncological | |||||||||
Elective | 153 | 52 | 205 | 0.57 | 6 | 72 | 17 | 95 | 0.18 |
Emergency | 12 | 6 | 18 | 1 | 14 | 8 | 23 | ||
Oncological | |||||||||
Elective | 59 | 26 | 85 | 0.25 | 17 | 40 | 9 | 66 | 0.16 |
Emergency | 16 | 12 | 28 | 6 | 12 | 8 | 26 | ||
All | |||||||||
Elective | 212 | 78 | 290 | 0.09 | 23 | 112 | 26 | 161 | 0.04 |
Emergency | 28 | 18 | 46 | 7 | 26 | 16 | 49 |
Revision surgeries
Number of patients | LOS (days) | Severity of Aes (mean) | |
---|---|---|---|
Non-oncological group | |||
Second unplanned surgeries during index admission | |||
None | |||
Readmissions within 2 years | |||
Construct failure with loss of correction | 8 | 17 | 3 |
Construct failure without loss of correction | 3 | 19.7 | 3 |
Deep wound infection | 3 | 20 | 3 |
Other (Hernia Relapse) | 1 | 12 | 3 |
Total | 15 | 17.8 | 3 |
Oncological group | |||
Second unplanned surgeries during index admission | |||
Hematoma | 1 | Estimated Effect on LOS: 3–7 gg | 3 |
Readmissions within 2 years | |||
Wound dehiscence | 6 | 13,5 | 3 |
Construct failure with loss of correction | 1 | 18 | 5 |
Construct failure without loss of correction | 1 | 17 | 3 |
Deep wound infection | 1 | 30 | 4 |
Other (recurrent disease) | 1 | 15 | 4 |
Total | 10 | 16.1 | 3.4 |
Procedure | Total | Uncomplicated patients | Complicated patients | p value | |||
---|---|---|---|---|---|---|---|
N | LOS (days) Mean ± SD | N | LOS (days) Mean ± SD | N | LOS (days) Mean ± SD | ||
Vertebroplasty | 75 | 2.3 ± 1.6 | 72 | 2.1 ± 1.4 | 3 | 5.0 ± 4.4 | 0.099 |
Hardware revision surgery | 29 | 11.4 ± 5.8 | 12 | 8.1 ± 2.4 | 17 | 13.8 ± 6.35 | 0.012 |
Laminectomy | 27 | 6.9 ± 3.0 | 21 | 6.1 ± 2.7 | 6 | 9.8 ± 2.1 | 0.005 |
Posterior fusion (TLIF or PLIF) with instrumentation | 26 | 9.2 ± 3.1 | 17 | 8.6 ± 3.9 | 9 | 11.2 ± 4.1 | 0.013 |
Posterior decompression with instrumentation | 21 | 9.8 ± 4.8 | 11 | 7.6 ± 4.0 | 10 | 12.1 ± 4.7 | 0.015 |
Minimal invasive herniectomy | 11 | 5.1 ± 3.4 | 10 | 4.6 ± 3.1 | 1 | 10.0 | 0.363 |
Posterior Deformity Correction and Fusion | 10 | 12.0 ± 3.3 | 3 | 8.7 ± 1.5 | 7 | 13.4 ± 2.7 | 0.033 |
Minimally invasive stabilization surgery (MISS) | 7 | 8.4 ± 6.2 | 6 | 6.3 ± 3.1 | 1 | 21.0 | 0.285 |
Anterior cervical fusion or corpectomy | 6 | 7.3 ± 2.9 | 5 | 6.6 ± 2.5 | 1 | 11.0 | 0.333 |
Spinal instrumentation removal | 4 | 6.5 ± 4.7 | 3 | 5.3 ± 4.9 | 1 | 10.0 | 1.000 |
Anterior lumbar fusion (ALIF or XLIF) | 3 | 9.3 ± 5.9 | 2 | 6.0 ± 1.4 | 1 | 16.0 | 1.000 |
Anterior cervical corporectomy and posterior stabilization | 2 | 15.0 ± 0.0 | 1 | 15.0 | 1 | 15.0 | 1.000 |
XLIF + Posterior Stabilization | 1 | 13.0 | 1 | 13.0 | – | ||
Sacro-iliac fusion | 1 | 5.0 | 1 | 5.0 | – | ||
Total | 223 | 6.8 ± 5.1 | 164 | 4.8 ± 3.4 | 59 | 12.2 ± 5.0 | – |
Procedure | Total | Uncomplicated patients | Complicated patients | p value | |||
---|---|---|---|---|---|---|---|
N | LOS (days) Mean ± SD | N | LOS (days) Mean ± SD | N | LOS (days) Mean ± SD | ||
Surgical decompression and stabilization | 52 | 13.5 ± 5.6 | 32 | 11.7 ± 4.3 | 20 | 16.4 ± 6.3 | 0.008 |
Intralesional resection | 28 | 10.3 ± 6.4 | 22 | 8.6 ± 4.4 | 6 | 16.2 ± 9.2 | 0.028 |
Vertebrectomy | 12 | 20.1 ± 6.2 | 4 | 15.0 ± 1.4 | 8 | 22.6 ± 6.2 | 0.048 |
Vertebroplasty | 8 | 2.4 ± 1.2 | 8 | 2.4 ± 1.2 | – | – | – |
Hardware revision surgery | 5 | 13.2 ± 6.3 | 3 | 11.3 ± 6.4 | 2 | 16.0 ± 7.1 | 1.000 |
Debridment | 4 | 19.5 ± 14.7 | 2 | 11.5 ± 4.9 | 2 | 27.5 ± 19.1 | 1.000 |
Minimally invasive stabilization surgery (MISS) | 2 | 17.5 ± 12.0 | 2 | 17.5 ± 12.0 | – | – | – |
En bloc resection | 2 | 6.5 ± 3.5 | 2 | 6.5 ± 3.5 | – | – | – |
Total | 113 | 12,6 ± 7.4 | 75 | 9.9 ± 5.3 | 38 | 18.0 ± 8.1 | – |
Length of stay
Risk factors for prolonged length of stay
Procedure | N | Mean days | SD | Median days | 75th percentile days |
---|---|---|---|---|---|
Vertebroplasty | 75 | 2.25 | 1.61 | 2.00 | 3.00 |
Hardware revision surgery | 29 | 11.45 | 5.80 | 9.00 | 13.00 |
Laminectomy | 27 | 6.93 | 3.01 | 7.00 | 9.00 |
Posterior fusion (TLIF or PLIF) with instrumentation | 26 | 9.19 | 3.11 | 8.50 | 9.00 |
Posterior decompression with instrumentation | 21 | 9.76 | 4.78 | 8.00 | 12.00 |
Minimal invasive erniectomy | 11 | 5.09 | 3.36 | 3.00 | 9.00 |
Posterior deformity correction and fusion | 10 | 12.00 | 3.27 | 12.00 | 14.00 |
Minimally invasive stabilization surgery (MISS) | 7 | 8.43 | 6.21 | 6.00 | 12.00 |
Anterior cervical fusion or corpectomy | 6 | 7.33 | 2.88 | 8.00 | 9.00 |
Procedure | N | Mean days | SD | Median days | 75th percentile days |
---|---|---|---|---|---|
Surgical decompression and stabilization | 52 | 13.50 | 5.57 | 12.50 | 16.00 |
Intralesional resection | 28 | 10.29 | 6.37 | 8.00 | 14.00 |
Vertebrectomy | 12 | 20.08 | 6.23 | 19.50 | 23.50 |
Vertebroplasty | 8 | 2.38 | 1.19 | 2.00 | 2.50 |
Hardware revision surgery | 5 | 13.20 | 6.26 | 15.00 | 15.00 |
OR (95% CI) | p value | |
---|---|---|
Age (years) | ||
> 66 versus ≤ 66 | 1.0 (0.5–1.7) | 0.8942 |
Sex | ||
M versus F | 0.7 (0.3–1.2) | 0.1960 |
ASA score | ||
2 versus 1 | 1.6 (0.6–4.3) | 0.5316 |
3 versus 1 | 1.8 (0.6–5.1) | |
CCI | ||
> 2 vs ≤ 2 | 0.7 (0.4–1.3) | 0.3570 |
Anatomical region | ||
Cervical versus thoracic | 1.2 (0.3–4.8) | 0.8755 |
Lumbosacral versus thoracic | 0.8 (0.3–2.3) | |
Thoracolumbar versus thoracic | 1.2 (0.4–3.4) | |
Lumbar versus thoracic | 1.3 (0.6–3.0) | |
Surgical time (hour) | ||
≥ 3 versus < 3 | 2.1 (1.1–4.0) | 0.0188 |
Instrumentation | ||
Yes versus no | 1.4 (0.8–2.5) | 0.2318 |
Postoperative AE | ||
Yes versus no | 3.8 (2.0–7.3) | < 0.0001 |
Type of hospitalization | ||
Emergency versus elective | 1.0 (0.4–2.9) | 0.9404 |
Previous surgery | ||
Yes versus no | 1.1 (0.6–2.0) | 0.8776 |
OR (95%CI) | p value | |
---|---|---|
Age (years) | ||
> 56 versus ≤ 56 | 4.9 (1.9–12.9) | 0.0012 |
Sex | ||
M versus F | 0.7 (0.3–1.5) | 0.3230 |
ASA score | ||
2 versus 1 | 6.1 (0.7–50.9) | 0.0770 |
3/4 versus 1 | 10.2 (1.2–84.9) | |
CCI | ||
> 5 versus ≤ 5 | 1.3 (0.6–3.1) | 0.5374 |
Anatomical region | ||
Cervical versus thoracic | 0.5 (0.1–2.8) | 0.2456 |
Thoracolumbar versus thoracic | 3.6 (0.8–16.0) | |
Lumbar versus thoracic | 1.2 (0.5–3.3) | |
Surgical time (hour) | ||
≥ 3 versus < 3 | 2.8 (1.1–6.9) | 0.0248 |
Instrumentation | ||
Yes versus no | 0.9 (0.4–2.1) | 0.7994 |
Intraoperative AE | ||
Yes versus no | 2.4 (0.8–6.7) | 0.1075 |
Postoperative AE | ||
Yes versus no | 4.4 (1.7–11.0) | 0.0017 |
Type of hospitalization | ||
Emergency versus Elective | 1.2 (0.4–3.0) | 0.7750 |
Previous surgery | ||
Yes versus no | 1.9 (0.8–4.4) | 0.1603 |
Primary tumor/metastases | ||
Metastases versus Primary tumor | 1.1 (0.5–2.5) | 0.9017 |
Pathological fracture | ||
1 versus 0 | 0.7 (0.2–2.2) | 0.5901 |
Radio pre | ||
1 versus 0 | 1.5 (0.6–3.7) | 0.4089 |
Chemio pre | ||
1 versus 0 | 1.4 (0.6–3.4) | 0.4954 |
Risk factors for AEs
OR (95% CI) | p value | |
---|---|---|
Age (years) | ||
> 75 versus ≤ 75 | 0.4 (0.2–0.9) | 0.0377 |
Sex | ||
M versus F | 1.5 (0.8–2.7) | 0.2250 |
ASA score | ||
2 versus 1 | 1.7 (0.6–4.5) | 0.2882 |
3 versus 1 | 1.0 (0.4–3.0) | |
CCI | ||
> 2 versus ≤ 2 | 0.7 (0.4–1.4) | 0.3324 |
Anatomical region | ||
Cervical versus thoracic | 8.2 (1.9–36.0) | 0.0492 |
Lumbosacral versus thoracic | 4.0 (1.2–13.5) | |
Thoracolumbar versus thoracic | 3.8 (1.1–13.3) | |
Lumbar versus thoracic | 2.5 (0.8–7.9) | |
Surgical time (hour) | ||
≥ 3 versus < 3 | 11.8 (5.8–23.6) | < 0.0001 |
Instrumentation | ||
Yes versus no | 7.4 (3.7–14.8) | < 0.0001 |
Type of hospitalization | ||
Emergency versus elective | 1.5 (0.5–4.1) | 0.4621 |
Previous surgery | ||
Yes versus no | 3.3 (1.8–6.3) | 0.0002 |
OR (95% CI) | p value | |
---|---|---|
Age (years) | ||
> 65 versus ≤ 65 | 1.0 (0.4–2.3) | 0.9638 |
Sex | ||
M versus F | 0.8 (0.4–1.7) | 0.5412 |
ASA score | ||
2 versus 1 | 1.9 (0.5–6.8) | 0.5885 |
3/4 versus 1 | 1.6 (0.5–5.8) | |
CCI | ||
> 2 versus ≤ 2 | 1.7 (0.7–3.9) | 0.2439 |
Anatomical region | ||
Cervical versus thoracic | 0.4 (0.1–1.5) | 0.4205 |
Thoracolumbar versus thoracic | 0.6 (0.2–1.3) | |
Lumbar versus thoracic | 0.7 (0.2–3.1) | |
Surgical time (hour) | ||
≥ 3 versus < 3 | 3.9 (1.7–9.0) | 0.0015 |
Instrumentation | ||
Yes versus no | 2.6 (1.1–6.1) | 0.0290 |
Type of hospitalization | ||
Emergency versus elective | 1.7 (0.7–4.1) | 0.2358 |
Previous surgery | ||
Yes versus no | 3.2 (1.4–7.2) | 0.0054 |
Primary tumor/Metastases | ||
Metastases versus primary tumor | 1.1 (0.5–2.4) | 0.8435 |
Pathological fracture | ||
1 versus 0 | 0.6 (0.3–1.8) | 0.3935 |
Radio pre | ||
1 versus 0 | 0.9 (0.4–2.2) | 0.8497 |
Chemio pre | ||
1 versus 0 | 2.2 (1.0–5.2) | 0.0638 |
Type of surgery* | ||
Hardware revision surgery versus intralesional resection | 2.4 (0.3–18.1) | 0.1449 |
Surgical decompression and stabilization versus Intralesional resection | 2.3 (0.8–6.6) | |
Vertebrectomy versus intralesional resection | 7.3 (1.6–32.9) | |
Vertebroplasty versus intralesional resection | Not reached |