Table 4:
Device/procedure/anesthesia–related adverse events during 2 years
| No. of Patientsa | Kyphoplasty (n = 191) | Vertebroplasty (n = 190) | |
|---|---|---|---|
| With procedure/device/anesthesia-related (or possibly) AEs | 12 | 11 | |
| Blood and lymphatic disorders | Bone marrow edema | 0 | 1b |
| Gastrointestinal disorders | Constipation | 1c | 0 |
| Immune system disorders | Hypersensitivity | 0 | 1c |
| Injury or procedural complications | Cement embolism | 1d | 1d |
| Implant site extravasation | 0 | 1e | |
| Mental status changes postoperative | 0 | 1c | |
| Procedural hypotension | 1c | 0 | |
| Procedural nausea/vomiting | 1c | 0 | |
| Procedural pain | 3f | 3f | |
| Spinal fracture | 1g | 0 | |
| Musculoskeletal disorders | Arthralgia | 1g | 0 |
| Back pain | 2g | 3g | |
| Muscle spasm | 1g | 0 | |
| Symptomatic vertebral fracture | 1g | 2g | |
| Psychiatric disorders | Hallucination | 1c | 0 |
| Respiratory disorders | COPD | 1c | 0 |
| Hypoxia | 0 | 1c | |
| Respiratory failure | 0 | 1c | |
| Vascular disorders | Hematoma | 0 | 1h |
Note:—COPD indicates chronic obstructive pulmonary disease.
Patients may have had multiple AEs; all system organ class categories are listed when there was an event considered related (or possibly related) to device/procedure/anesthesia.
In 1 patient, 1 event was considered nonserious and possibly related to bone cement.
In 1 patient, 1 event was considered serious and related (or possibly related) to anesthesia and was resolved with medical intervention.
In 1 patient, 1 event each was considered serious and bone cement–related (or possibly related). In each case, the event occurred after the surgical treatment of a subsequent fracture; the BKP event was resolved with oxygen, and the VP event was ongoing at final follow-up.
In 1 patient, 1 event was considered bone cement–related and nonserious. A spinal canal leak was detected intraoperatively; CT was immediately performed without significant canal stenosis observed with no medical intervention given.
Three patients in each group with 3 (2 serious) and 4 (all serious) events in the BKP and VP groups, respectively, were considered device-related (or possibly related) but were resolved.
The number of patients reflected in the Table had events that were considered serious and related (or possibly related) to the device.
In 1 patient, 1 event was nonserious and possibly related to the procedure (likely a prone position on the operating table).