Standards of practice

Position Statement on Percutaneous Vertebral Augmentation: A Consensus Statement Developed by the American Society of Interventional and Therapeutic Neuroradiology, Society of Interventional Radiology, American Association of Neurological Surgeons/Congress of Neurological Surgeons, and American Society of Spine Radiology

The aim of the study was to determine the effectiveness of percutaneous balloon kyphoplasty for treatment of compressive vertebral fractures.

A retrospective analysis was conducted on 24 patients with 58 symptomatic vertebral fractures treated by balloon kyphoplasty. Visual Analogue Pain Scale (VAS) and Oswestry Disability Index (ODI) were used to assess fracture-related pain and patient's disability: preoperatively and within 12-months follow-up. Following the procedures to evaluate the change of vertebral deformity, the angle of local kyphosis was measured.

Preoperative VAS score was 6.54, at discharge it significantly regressed in 95.8% of patients. The overall VAS score at discharge was 1.25 and within 12 months decreased to 0.26. Preoperative ODI score was 50%, at follows-up in all patients it decreased, ranging from 21% to 10%. Reduction of local kyphosis was achieved in 30 (51.7%) vertebrae by average 4.3°. In 9 (37.5%) patients kyphosis of all augmented vertebrae was reduced, in 7 (29.2%) patients procedures reduced kyphosis in part of augmented vertebrae and in 8 patients (33.3%) kyphosis remained unchanged. Asymptomatic complications included cement leak in 10 (17%) vertebrae and intraoperative rupture of 4 (4%) balloons.

Rapid significant pain relief after kyphoplasty followed by long-term pain release and disability reduction obtained in all patients was most probably the result of vertebral augmentation. The correction of local kyphosis had no influence on the outcome.

The purpose of this study was to prospectively evaluate results and complications of percutaneous vertebroplasty (PV) performed in 6 different Italian Centres belonging to the European VErtebroplasty RESearch Team (E.VE.RES.T) in a large series of patients.

Follow-up was obtained in 4547 patients (3211 females and 1336 males; mean age 70.2 years) that underwent PV for a total of 13.437 treated vertebrae. Procedures were performed by using fluoroscopic guidance or combined CT-fluoroscopic guidance. All patients underwent PV in local anaesthesia except for second cervical vertebrae treated with a trans-oral approach that required general anaesthesia.

4004 out of 4547 (88.0%) patients reported significant pain relief (difference > or = 2 point in pain evaluated with an 11-point visual analogue scale; p < 0.0001) within 48 h: an average of 7.7 ± 0.4 dropped to 1.8 ± 0.6 in the osteoporotic patients; 8.3 ± 0.4 to 2.4 ± 0.4 in metastases; 8.3 ± 0.4 to 1.7 ± 1.0 in myeloma; 6.2 ± 3.5 to 0.3 ± 0.2 in angioma and 7.4 ± 0.4 to 1.4 ± 0.9 in trauma. 430 osteoporotic patients (13%) were retreated for a subsequent fracture; in 302/430 patients (70.2%), the new fracture occurred in the contiguous vertebra. No major neurologic complications were reported and the most frequent minor complication was venous leakage (20.5%).

This large series of patients confirms that percutaneous vertebroplasty is an effective and safe procedure in the treatment of vertebral fractures. Best results are obtained in the treatment of myeloma and trauma.

Percutaneous vertebroplasty (PVP) is a common treatment modality for painful osteoporotic vertebral compression fractures (OVCFs). The complication rate of PVP is low, but cement leakage occurs in up to 90% of the treated levels. Recent evidence suggests that sequelae of cement leakage may be more common and clinically relevant than previously thought. Preoperative appreciation of risk factors would therefore be helpful but has not been thoroughly investigated.

Identification of preoperative risk factors for the occurrence of cement leakage in PVP for painful OVCFs.

Retrospective assessment of risk factors using multivariate analysis.

Eighty-nine patients treated with PVP for 177 painful OVCFs.

Occurrence of cement leakage.

The influence of all known risk factors and other parameters potentially affecting the occurrence of cement leakage was retrospectively assessed using multivariate analysis. Patient age, sex, and spinal deformity index; fracture age, level, type, and semiquantitative severity grade (1–4), the presence of an intravertebral cleft and/or cortical disruption on preoperative magnetic resonance imaging (MRI), and the viscosity of bone cement were included. Cement leakage was assessed on direct postoperative computed tomography scanning of the treated levels. In addition to cement leakage in general, three fundamentally different leakage types (cortical, epidural, and anterior venous), with different possible clinical sequelae, were discerned, and their respective risk factors were assessed.

In 130 of 173 (75.1%) treated OVCFs, cement leakage was detected. Leakage incidence was found to increase approximately linear with advancing severity grade. High fracture semiquantitative severity grade (adjusted per grade relative risk [RR], 1.14; 95% confidence interval [CI], 1.05–1.24; p=.002) and low bone cement viscosity (medium vs. low viscosity: adjusted RR, 0.73; 95% CI, 0.61–0.87; p<.001) were strong risk factors for cement leakage in general. For cortical leakage (in 95% intradiscal leakage), the presence of cortical disruption on MRI (adjusted RR, 1.62; 95% CI, 1.16–2.26; p=.004) and an intravertebral cleft on MRI (adjusted RR, 1.43; 95% CI, 1.07–1.77; p=.017) were identified as additional strong risk factors.

High fracture severity grade and low viscosity of polymethylmethacrylate bone cement are general, strong, and independent risk factors for cement leakage. Using MRI assessment, cortical disruption and the presence of an intravertrebral cleft were identified as additional strong risk factors regarding cortical (intradiscal) cement leakage, thereby potentiating anticipation.