. 2016 May 1;16(11):1–202.

Table 34:

Complications Reported in Clinical Studies of Vertebral Augmentation for High-Risk Vertebral Compression Fractures

Author, Year Country	Patients, N (F, M) Age, Mean ± SD (Range)^a Primary Cancer, Risk Features	Operator Interventions and Treated Spinal Levels	Minor Complications, n	Major Complications, n
Vertebroplasty for Vertebral Fractures with Spinal Canal and/or Posterior Wall Defects
Alvarez et al, 2003¹²³ Spain	21 patients (14 F, 7 M) 58 years (27–78) All had nonskeletal metastases, 76% had concomitant bone metastases elsewhere, and 10 had neurological deficits Mixed metastatic cancers	Interventional neuroradiology VP under conscious sedation and analgesia at 27 VB levels and subsequent PRT (n = 15) and neural decompression (n = 3)	n = 1 Bone cement leakage caused a transient radicular neuritis (n = 1) Bone cement leakage detected by CT occurred in 44% (12/27) of treated vertebrae; leaks were in the disc (n = 1), entry site (n = 1), and epidural veins (n = 10)	None reported
Appel et al, 2004¹²⁴ United States	23 patients (17 F, 6 M) Age NR All had MRI-defined varying degrees of spinal canal compromise; cancer-related (n = 7) and osteoporotic (n = 16)	Interventional radiology VP under conscious sedation and analgesia at 26 VB levels (19 T, 7 L)	n = 3 Post-procedural dyspnea with decreased oxygen saturation requiring up to 4 L of oxygen by nasal cannula after a 4-level VP (n = 1) A chest radiograph showed segmental atelectasis, and PE was excluded by clinical examination and ventilation-perfusion scintigraphy (n = 1) After initial decreased pain, pain occurred bilaterally in lower extremities; no radiographic complications were noted, neurological exam findings were nonfocal, and symptoms improved without further intervention (n = 1) Bone cement leakage occurred, but the events were only reported as asymptomatic	None reported
Basile et al, 2011¹¹⁵ Italy	24 patients (13 F, 11 M) 54.7 years (42–67) Multiple myeloma	Interventional radiology VP at 34 VB levels (16 T, 18 L)	Asymptomatic bone cement leakage occurred in 6% (2/34) of treated vertebrae; all had large epidural space extension without increased neurological symptoms	None reported
Georgy et al, 2009¹¹⁸ United States	37 patients (21 F, 16 M) Range 34–89 years	Interventional radiology RFA and VP at 44 VB levels	n = 3 3 patients underwent selective nerve blocks after VP, 2 being symptomatic due to tumour extension into the neural foramina Asymptomatic bone cement leakage occurred in 70% (31/44) of treated vertebrae; leaks were venous (n = 18, 40%), cortical (n = 10, 22%) and discal (n = 5, 11%)	n = 1 2 small epidural leaks were noted; 1 occurred adjacent to the neural foramen, associated with radicular symptoms; the patient was treated with selective nerve root blocks, resulting in pain relief
Hentschel et al, 2004²⁰² United States	1 patient (1 F) 60-year-old Vertebra plana (85% collapse of anterior T7) with an associated epidural hematoma and retropulsion into the ventral aspect of the spinal cord, compressing the anterior thoracic spinal cord; thymic cancer and history of renal cell carcinoma	Neurosurgery VP at T7 VB; during the procedure, the thoracic VB was compressing and expanding about 30% of its height during breathing	Post-operative imaging revealed anterior placement of cement without leakage into the spinal canal or neural foramina	None reported
Li et al, 2013¹²¹ Gu et al, 2014¹³⁵ China	28 of 52 patients 59.6 years (37–90) Neurological symptoms of cord compression	Interventional radiology VP under conscious sedation and analgesia at 56 VB levels	Bone cement leakage occurred in 52% (29/56) of treated vertebrae; leaks were in the intervertebral disc (n = 6), access site (n = 3), paravertebral space (n = 7), veins (n = 12) or spinal canal (n = 1)	n = 1 Bone cement leakage into the spinal canal resulted in complete paraplegia
Li et al, 2013¹²¹ Gu et al, 2014¹³⁵ China	24 of 52 patients 59.6 years (37–90) Neurological symptoms of cord compression	VP and ITR under conscious sedation and analgesia at 38 VB levels	n = 2 Increased acute pain following the procedure, resolved with IV corticosteroids (n = 2) Asymptomatic cement leakage occurred in 32% (12/38) of treated vertebrae; leaks were in the intervertebral disc (n = 3), access site (n = 2), paravertebral space (n = 4), or veins (n = 3); none were in the spinal canal	None reported
Mazumdar et al, 2010¹²⁵ United States	Case 1 1 patient (F) 71-year old Metastatic breast cancer Case 2 1 patient (M) 60-year-old Multiple myeloma Both had radiculopathy when upright and relieved when recumbent	Interventional radiology Case 1 VP at L4 for pain and lower-extremity weakness Case 2 RFA (coblation) and VP at L3 with tumour filling the vertebrae and compressing the spinal canal and having radicular pain and mild right-leg weakness	None reported	None reported
Prologo et al, 2013¹¹⁹ United States	15 patients (8 F, 7 M) 67.8 ± 15.3 years Mixed metastatic cancers and multiple myeloma; risk features involved cortical disruption, retropulsion of bony fragments, tumour invasion epidural space, and/or spinal canal stenosis at the disease level	Interventional radiology RFA (coblation) and VP at 15 VB levels (3 T, 12 L) under biplane fluoroscopy (n = 8), CT (n = 2), or combined CT fluoroscopy (n = 5)	n = 1 Transient hypotension due to IV sedatives resolving without medical intervention (n = 1) No cement leakage occurred (on CT, MRI, PET-CT)	None reported
Saliou et al, 2010¹³¹ France	51 patients (22 F, 29 M) 62.5 years (28–85) Mixed metastatic cancers and multiple myeloma; VCFs with epidural involvement of at least 1 level and with or without neurological symptoms; 15 patients had signs of spinal cord or cauda equina compression—11 with complete paraplegia and 4 with incomplete paraplegia; 3 patients underwent surgical laminectomy at the level of epidural involvement 48 hours prior to VP	Interventional neuroradiology VP under conscious sedation and analgesia or general anaesthesia (depending on the patients’ condition and number of treated vertebrae) at 74 VB levels—50 with vertebral wall destruction and associated epidural involvement; PRT was administered in 40 cases (10 cases before VP and 30 cases after)	Bone cement leakage occurred in 61% (45/74) of treated vertebrae; all but 1 were asymptomatic	n = 1 A 74-year-old woman with metastatic pancreatic adenocarcinoma who had radiculopathy and no prior neurological symptoms underwent PRT prior to VP for a L3 VCF with posterior wall destruction and epidural involvement; 2 days post-VP, she experienced symptoms of cauda equina that were managed by emergency decompression surgery with good results
Shimony et al, 2004¹³⁰ United States	50 patients (25 F, 25 M) 62.7 years ± 14 years Mixed metastatic cancers and multiple myeloma; epidural tumour involvement: none (n = 14), mild (n = 18), or moderate (n = 18)	Interventional radiology VP under conscious sedation and analgesia at 129 VB levels in 60 sessions	None reported Asymptomatic cement leakages were not counted	n = 7 14% (7/50) of cases experienced new or increased pain (3 at the level of the treated vertebrae), none requiring surgery Those with immediate pain were treated with central epidural or intravenous steroid injections; those with delayed increased pain were treated with neuroforaminal epidural nerve root blocks Of the 7 cases, none occurred in those without epidural involvement; 3 were in those with minimal epidural involvement and 4 were in those with moderate epidural involvement
Sun et al, 2011¹³², 2014¹²⁶ China	43 patients (24 F, 19 M) 64.1 years (34–84) Mixed metastatic cancers; VCF with involvement of the epidural space around the cord and/or cord compression; study group from 412 consecutive spinal metastases	Interventional radiology VP under conscious sedation and analgesia at 69 VB (T3 to L5) levels; radiation therapy was not indicated in 27 patients who had already had the maximum radiation dose for local lesions; radiation therapy had been delayed or incomplete in 16 patients	Asymptomatic bone cement leakage occurred in 70% (48/69) of treated vertebrae; leaks were in the intervertebral disc (n = 15), paravertebral (n = 12), epidural space (n = 14), foramina (n = 3), and access track (n = 4) Overall extraosseous bone cement leakage was not related to epidural involvement, but leakage in the spinal canal was associated (P = .017) with the degree of fracture tumour epidural involvement with or without spinal cord deformity	None reported
Trumm et al, 2012¹²⁷ Germany	202 patients (116 F, 86 M) 63.2 ± 8.6 years Mixed metastases and multiple myeloma; vertebral fractures had varying degrees of associated spinal column tumour involvement: none (n = 260), mild (n = 43), or moderate (n = 28)	Interventional radiology VP only under CT-guidance in 231 sessions at 331 VB levels VP performed at one level (n = 140), two levels (n = 82), or three levels (n = 9)	n = 6 Transient chest pain during cement injection resolving after VP (n = 2) Transient radiating gluteal pain resolving after VP (n = 1) Inadequate per-interventional analgesia (n = 1) Inadvertent radicular irritation during unsuccessful positioning of VP cannula at C7; VP was abandoned and anterior instrumentation from C6 to T1 was performed (n = 1) Decreased oxygen saturation after administration of 1.5 mg midazolam during RFA requiring antidote flumazenil (n = 1) Bone cement leakage occurred in 59% (194/331) of treated vertebrae; leaks were in the intervertebral discs (n = 85) or paravertebral (n = 79 with 65 leaks to segmental vein), intraspinal (n = 69 with 55 leaks to the basivertebral vein) or foraminal (n = 2) regions; leaks were not associated with epidural soft tissue involvement, degree of osteolytic involvement or fractured end plate	n = 11 Pulmonary bone cement embolism occurred in 5% (11/202) of cases; 10 patients had segmental PE (6 with single embolus in 1 lobe, 3 with emboli in 2 different lobes, 1 with emboli in all 5 lobes) and 1 patient showed a combination of 1 major central and 2 segmental embolisms
Van der Linden et al, 2007¹²⁰	12 patients (4 F, 8 M) 57 years (31–79) Mixed metastatic cancers and multiple myeloma; VCFs with posterior wall defect and a maximum ⅓ spinal canal area obstruction (3 cases) unresponsive to medical therapy, radiation therapy and/or medical therapy	Interventional radiology and orthopaedic surgery VP and RFA under conscious sedation and analgesia (general anaesthesia for C level) for 12 vertebrae (2 C, 4 T, 6 L)	Asymptomatic bone cement leakage occurred in 58% (7/12) treated vertebrae Leaks were in the venous plexus (n = 5), through the posterior cortical wall defect (n = 2)	n = 1 Pneumonia occurred 30 days post-procedure for a patient treated for a T4 VCF (n = 1)
Woo et al, 2013¹²⁸ Korea	1 patient (M) 52-year-old Cholangiocarcinoma; extensive VCFs with L4 dorsal root nerve compression and neurological symptoms	Anaesthesiology VP for 2 masses extending to the posterior-inferior portion of the L4 vertebral body and the lowest level of the left pedicle, with compression of the left L4 nerve root in the left foraminal region without motor deficits; bilateral L4/5 transforaminal epidural blocks unsuccessfully managed bilateral radiating leg pain; patient was unable to stand due to weakness	None reported	None reported
Kyphoplasty or Kyphoplasty and Vertebroplasty for Vertebral Fractures with Spinal Cord and/or Posterior Wall Defects
Dalbayrak et al, 2010¹³³ Turkey	31 patients (17 F, 14 M) 62 years (35–78) Mixed metastatic cancers and multiple myeloma	Neurosurgery KP under conscious sedation and analgesia at 39 VB levels (T or L) KP performed at one level (n = 22), two levels (n = 8), or three levels (n = 1)	Asymptomatic bone cement leakage occurred in 33% (13/39) of treated vertebrae; leaks occurred at the epidural (n = 4), upper intervertebral disc (n = 2), lower intervertebral disc (n = 4), and paravertebral muscles (n = 3)	None reported
Eleraky et al, 2011¹²² United States	14 of 23 patients (6 F, 8 M) 62 years (41–71) Mixed metastatic cancers and multiple myeloma	Neurosurgery KP under general anaesthesia at 30 VB levels (T1 to T5) KP performed at one level (n= 5), two levels (n = 2), or three levels (n = 7)	Asymptomatic bone cement leakage occurred in 10% (3/30) of treated vertebrae	None reported
Hentschel et al, 2005¹¹⁶ United States	66 patients Group 1 (no contraindications) 49 patients (24 F, 25 M) Median 64 years (29–88) Group 2 (contraindications) 17 patients (8 F, 9 M) Median 61 years (42–75)	Neurosurgery Group 1 VP at 89 VB levels KP at 22 VB levels Group 2 VP at 13 VB levels KP at 5 VB levels	Bone cement leakage in Group 1 occurred in 11% (13/114) of treated vertebrae and in Group 2 occurred in 39% (7/18) of treated vertebrae The most common site of leaks in both groups was anterior to the VB in the retroperitoneal space surrounding the vertebrae or prevertebrally (11/20) and intradiscally or anterior to the VB (8/20)	n = 1 In 1 patient, cement extrusion into the intervertebral foramen resulted in transient radicular pain, which resolved with a short course of corticosteroids (n = 1)
Knight et al, 2008¹¹⁷ Canada	3 patients (3 F) 32-year-old, 59-year-old, 67-year-old Spinal canal narrowing due to retropulsed fragments	Interventional radiology 2 VP and 1 KP under C-arm cone-beam CT guidance	Asymptomatic cement leakage in all cases	None reported
Lim et al, 2011¹³⁴ Korea	1 patient (F) 76-year-old Gastric cancer and hilar cholangiocarcinoma; cauda equina syndrome due to VCF and with epidural involvement	Interventional radiology KP under conscious sedation and analgesia; compression fractures with fluid-filled clefts in T12 and L1, and retropulsion of mass into epidural space with compression of the conus medullaris at the T12–L1 level	No cement leakage was observed with a controlled 2-stage injection method	None reported

Abbreviations: C, cervical; CT, computed tomography; F, female; ITR, interventional tumour removal; IV, intravenous; KP, kyphoplasty; L, lumbar; M, male; MRI, magnetic resonance imaging; NR, not reported; PE, pulmonary embolism; PET, positron-emission tomography; PRT, palliative radiotherapy; RFA, radiofrequency ablation; SD, standard deviation; T, thoracic; VB, vertebral body; VCF, vertebral compression fracture; VP, vertebroplasty.

Unless otherwise indicated.