Kyphoplasty

Balloon Kyphoplasty Orthopaedic Treatment of Vertebral Compression Fractures

Vertebral Fracture: Associated Conditions Diagnosis of osteoporosis Glucocorticoid therapy (≥ 7.5 mg prednisolone) Postmenopausal women > age 55 Loss of 2 or more inches in height Prominent thoracic kyphosis Low BMD Ismail AA et al. Osteoporos Int . 1999;9:206–213.

Radiologic Assessment A lateral spine X-ray examination is a method that can be used to screen for the presence of vertebral compression fractures. STIR sequence MRI can be useful to determine index and/or plain radiograph culprit. Palpating each spinous process to rule out disc pain as the underlying culprit would also be of value in the initial assessment of the patient to differentiate between back pain and vertebral compression fracture pain.

Radiologic Assessment 8 weeks post fracture First week post fracture Courtesy of B. Boszczyk & R. Bierschnieder, BG Unfallklinik, Dept. of Neurosurgery, Murnau, Germany MRI: T2 Image

Vertebral Fracture Progression Some fractures may collapse acutely while others collapse progressively over time. Lyritis et al. (1989) Clin Rheum Suppl 2(8):66-69

Location of Vertebral Fractures Are most commonly located at the midthoracic region (T7–T8) and the thoracolumbar junction (T12–L1) 1 Midthoracic region – thoracic kyphosis is most pronounced and loading (stress) during flexion is increased Thoracolumbar junction – the relatively rigid thoracic spine connects to the more freely mobile lumbar segments 2 Correspond to the most mechanically compromised regions of the spine Nevitt MC et al. Bone . 1999;25:613–619. Cooper C et al. J Bone Min Res . 1992;7:221–227.

Vertebral Fractures: Three types Wedge Biconcave Crush Wedge fractures are most common Genant HK et al. J Bone Miner Res . 1993;8:1137–1148.

Decreased Quality of Life Physical and functional performance lower in patients with VCF 1,2 Restricted ADL - patients need assistance from family or hired help Sleep disturbances Early satiety Patients suffer psychosocial consequences 3 anxiety, depression, low self-esteem, and alteration in social role 1. Lyles et al. (1993) Am J Med 94: 595-601 2. Silverman SL (1992) Bone 13, S27-S31 3. Gold DT (1996) Bone 3: S185-S189

Pulmonary Function Pulmonary function (FEV1) is significantly reduced in patients with osteoporotic VCF vs. non-osteoporotic patients with low back pain. Normal Posture Stooped Posture Schlaich C, et al. (1998) Osteoporosis Int’l 8:261-267

Future Fracture Risk After first VCF, risk of subsequent VCF is increased: 5-fold after first VCF 12-fold after 2 or more VCFs 75-fold after 2 or more VCFs and low bone mass (below the 33 rd percentile) Ross et al. (1991) Annals of Internal Med. 114 (11): 919-923

Risk of fracture from steroid use Users of oral glucocorticoids have a 2.6-fold increase risk of fracture van Staa TP et al. J Bone Miner Res. 2000;15:993–1000. Risk of vertebral fracture Oral glucocorticoid users (n=244,235) Age- and gender- matched controls (n=244,235)

Mortality Study of Osteoporotic Fractures cohort study: Women ≥ 65 years (n=9,515) with or without vertebral fracture Conclusions Women with prevalent vertebral fracture had a 23% higher age-adjusted mortality rate VCF patients are two to three times more likely to die of pulmonary causes Most common cause of death was pulmonary disease, i.e., COPD and pneumonia Kado DM et al. Arch Intern Med . 1999;159;1215–1220.

Balloon Kyphoplasty Stabilizes the Fracture and Corrects Spinal Deformity caused by one or more VCFs

The Procedure Minimally invasive Bilateral, 1cm incisions Typically one hour per treated fracture General or local anesthesia Can be performed under local anesthesia, often supplemented with conscious sedation. Among 155 prospectively enrolled patients in Kyphon U.S. study, only 1 complication was related to anesthesia. May require an overnight hospital stay Kyphon U.S. Study. Data on file at Kyphon Inc.

Case Study 19 o 3 o 15mm 28mm Patient: 91 YO Female Diagnosis: Primary osteoporosis Fracture Reduced: L-1, 4 months old Courtesy of Alexander Hadjipavlou, M.D., Crete, Greece

Case Study Patient: 78 YO Female Diagnosis: Primary osteoporosis Fracture Reduced: L-1 & L-2 6 weeks old Courtesy of Frank Phillips, MD, Chicago, IL (L3 Treated 6 Wks Prior) L1-L2 Height Restoration

Correction of Vertebral Body Deformity Studies report the following radiographic outcomes post kyphoplasty: Percent lost vertebral body height restored Percent vertebral body height increased Angular deformity correction

Example: Percent Lost Height Restored % Lost Height Restored = (24 – 20) / (30 - 20) or 4/10 = 40% 20 mm 24 mm Avg. 30 mm

Percent Lost Height Restored Kyphon U.S. Study. Data on file at Kyphon Inc. Theodorou et al (2002) J Clin Imaging 26:1-5 Lieberman et al (2001) Spine 26: 2, 1631-1638 NR = Not Reported Study Vertebral Body Site Mean Fracture Age (mos.) % Lost vertebral Body Height Restored All Fractures Reducible Fractures % N % N U.S. Study Midline 4.3 30.2 65 58 47 Lieberman (2001) Midline 5.9 35 70 47 49 Theodorou (2002) Midline 3.2 66 24 NR NR Theodorou (2002) Anterior 3.2 52 24 NR NR

Case Study: Correction of Angular Deformity Kyphosis = 25 º Kyphosis = 10 º Kyphosis = 16 º Immediate post- fracture Post-kyphoplasty Post-fracture + 4 days Lieberman et al. (2001) Spine 26: 2, 1631-1638

Balloon Kyphoplasty Clinical Outcomes

Clinical Outcomes Studies report the following clinical outcomes post kyphoplasty: Correction of vertebral body deformity Significant reduction in pain Improvement in quality of life Improvement in ability to perform activities of daily living Low complication rate

Reduction in Pain Following Balloon Kyphoplasty, patients report significant pain reduction at short-term follow-up, sometimes within hours of the procedure. In a retrospective analysis (Garfin et al (2001)), patients discontinued use of narcotics for fracture-related pain, changing to over-the-counter analgesics post operatively. Coumans et al. (2003) prospectively followed 78 consecutive patients for 12 to 18 months and reported substantial improvement (p<0.001) in bodily pain as measured by SF-36. Results persisted at three months. Garfin SR, Yuan HA, Reiley MA (2001). Spine 26:1511-1515 Theodorou et al (2002) J Clin Imaging 26:1-5 Coumans JV, Reinhardt MK, Lieberman I (2003) J Neurosurg (Spine 1) 99:44-50

Reduction in Pain In the prospective multicenter U.S. study, there was an average of 60% reduction in pain at one week follow-up. Results persisted for two years (n=100). Kyphon U.S. Study. Data on file at Kyphon Inc.

Ambulatory Status Ledlie et al (2002) (n=79) 80% were fully ambulatory at one week follow-up. 27 of the pts. followed at one year maintained full ambulatory status. 90% of all patients who were wheelchair-bound pre-operatively were ambulatory at one week follow-up. Ledlie et al. (2003) J Neurosurg (Spine 1) 98: 36-42

Risk of Subsequent Fracture Komp et al (2004) A controlled, prospective study 21 patients underwent balloon kyphoplasty and 19 underwent conservative treatment. Patient populations were similar in age, gender, fracture history, and other risk factors. After six months, 7 out of 19 evaluable balloon kyphoplasty patients had new fractures (37%), whereas 11 out of 17 conservatively-treated patients (67%) had new fractures. Conclusions: Incidence of adjacent and non-adjacent fracture in both arms corresponds to other published data. A larger study is needed to assess risk of subsequent fracture. Komp, et al. (2004) J Miner Stoffwechs 11(Suppl 1):13-16 (German)

Low Complication Rate U.S. Study = no serious procedure-related complications in 214 fractures in 155 patients treated One patient experienced an intraoperative arrhythmia (PSVT) Kyphon U.S. Study. Data on file at Kyphon Inc. * Lit review: See bibliography at end of presentation

Overall Procedure-Related Complication Rate Overall procedure-related complication rate for balloon kyphoplasty-treated patients was 0.89% versus 5.44% for vertebroplasty (p=0.0009). Statistically significant difference also demonstrated in sub-analyses of fractures due to osteoporosis or cancer .

Bone Cement Procedure-Related Complication Rates The total bone cement procedure-related complication rate for balloon kyphoplasty was 0.22% versus 3.07% for vertebroplasty (p=0.0008). The calculation of bone cement-related complications excluded asymptomatic cement extravasations.

Bone Cement Procedure-Related Complication Rates The combination of compaction of cancellous bone , cavity creation , and controlled cement delivery suggests the difference in adverse events is caused by cement extravasation. Compaction of Cancellous Bone: Balloon inflation compacts the cancellous bone, disrupts internal venous pathways and fills fracture lines, reducing leak pathways. Cavity Creation and Controlled Bone Cement Delivery: Upon balloon removal, an intervetebral cavity is left behind, allowing for the delivery of a known volume of doughy bone cement (KyphX ® HV-R  ) under low pressure and fine manual control. Phillips et al. (2002) Spine 27:2173-2179 Togawa et al. (2003) Spine 28:1521-1527

Adverse Events Although the complication rate with Balloon Kyphoplasty has been demonstrated to be low, as with most surgical procedures, there are risks associated with Balloon Kyphoplasty, including serious complications. Serious adverse events, some with fatal outcome, associated with the use of acrylic bone cements include cardiac arrest, cerebrovascular accident, myocardial infarction, and pulmonary embolism. Other reported adverse events relevant to the anatomy being treated with acrylic bone cements include deep or superficial wound infection, fistula, hematoma, hemorrhage, heterotopic new bone formation, nerve entrapment due to extrusion of bone cement beyond the region of its intended use, pyrexia due to allergy to bone cement, short-term conduction irregularities, thrombophlebitis, and transitory fall in blood pressure. Physicians should review the product Instructions for Use for a full discussion of the risks.

Patient Satisfaction: U.S. Study Reports patient satisfaction with the outcomes of the kyphoplasty procedure Measured on a scale of 1 – 20 1 = completely dissatisfied 20 = completely satisfied RESULT: 17.5 at one week and maintained at 2 yrs Kyphon U.S. Study. Data on file at Kyphon Inc.

Conclusion VCFs occur more than hip and wrist fractures combined. Balloon kyphoplasty is an available option associated with a low complication rate for patients suffering from painful VCFs. Balloon kyphoplasty can provide fracture stabilization and correction of spinal deformity. Patients experience significant reduction in pain and improvement in mobility, thus increasing overall quality of life.

References: Literature review of 1342 fractures treated with kyphoplasty Boszczyk et al. (2004) Microsurgical interlaminary vertebro- and kyphoplasty for severe osteoporotic fractures. J Neurosurg (Spine 1) 100:32-37 Coumans et al (2003) Kyphoplasty for vertebral compression fractures: 1-year clinical outcomes from a prospective study. J Neurosurg (Spine 1) 99:44-50 Dudeney et al. (2002) Kyphoplasty in the treatment of osteolytic vertebral compression fractures as a result of multiple myeloma. J Clin Oncol 20:2382-2387 Fourney et al. (2003) Percutaneous vertebroplasty and kyphoplasty for painful vertebral body fractures in cancer patients. J Neurosurg (Spine 1) 98:21-30 Garfin SR, Yuan HA, Reiley MA (2001) Kyphoplasty and vertebroplasty for the treatment of painful osteoporotic compression fractures. Spine 26:1511-1515 Komp et al. (2004) Minimally invasive therapy for functionally unstable osteoporotic vertebral fracture by means of kyphoplasty: Prospective comparative study of 19 surgically and 17 conservatively treated patients. J Miner Stoffwechs 11 (Suppl 1):13-15 Kyphon U.S. Multicenter Prospective Single Arm Study. Data on file at Kyphon Inc. Lane et al. (2002) Minimally invasive options for the treatment of osteoporotic vertebral compression fractures. Orthop Clin N Am 33:431-438 Ledlie J, Renfroe M (2003) Balloon Kyphoplasty: One Year Outcomes in Vertebral Body Height Restoration, Chronic Pain, and Activity Levels. J Neurosurg (Spine 1) 98: 36-42 Lieberman et al (2001) Initial Outcome and Efficacy of Kyphoplasty in the Treatment of Osteoporotic VCFs. Spine 26: 2, 1631-1638 Lieberman IH, Reinhardt M-K (2003) Vertebroplasty and kyphoplasty for osteolytic vertebral collapse. Clin Orthop 415(Suppl):S176-S186 Phillips et al. (2003) Early radiographic and clinical results of balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures. Spine 28, 19: 2260-2267 Phillips et al. (2002) An In Vivo Comparison of the Potential for Extravertebral Cement Leak After Vertebroplasty and Kyphoplasty. Spine 27, 19: 2173-2179 Theodorou DJ, Theodorou SJ, Duncan T, Garfin SR, Wong W (2002) Percutaneous Balloon Kyphoplasty for the Correction of Spinal Deformity in Painful Vertebral Compression Fractures. J Clin Imaging 26:1-5 Voggenreiter G, Sadik M, Majetschak M, et al. (2004) Treatment results of the kyphoplasty balloon technique. MedReview:17-18 Wilhelm K, Stoffel M, Ringel F, et al. (2003) Preliminary experience with balloon kyphoplasty for the treatment of painful osteoporotic compression fractures. Fortschr Rontgenstr 175:1690-1696 Wong W, Reiley MA, Garfin SR (2000) Vertebroplasty / Kyphoplasty. J Women’s Imaging 2(3)

Al-Assir I, Perez-Higueras A, Florensa J, et al. (2000) Percutaneous vertebroplasty: A special syringe for cement injection. AJNR Am J Neuroradiol 21:159-161 Amar AP, et al. (2003) Use of a screw-syringe injector for cement delivery during kyphoplasty: technical report. Neurosurgery 53(2):380-383 Appel NB, Gilula LA (2004) Percutaneous vertebroplasty in patients with spinal canal compromise. AJR 182:947-951 Barr J, Barr M, Lemley T, et al. (2000) Percutaneous vertebroplasty for pain relief and spinal stabilization. Spine 25:923-928 Berlemann U, et al. (2004) Kyphoplasty for treatment of osteoporotic vertebral fractures; a prospective non-randomized study. Eur Spine J, 2004 Feb 25 Bernhard J, Heini PF, Villiger PM (2003) Asymptomatic diffuse pulmonary embolism caused by acrylic cement: An unusual complication of percutaneous vertebroplasty. Ann Rheum Dis 62:85-86 Boszczyk BM, Bierschneider M, et al. (2004) Microsurgical interlaminary verterbro- and kyphoplasty for severe osteoporotic fractures. J Neurosurg 100(1 Suppl):32-37 Brown DB, Gilula LA, et al. (2004) Treatment of chronic symptomatic vertebral compression fractures with percutaneous vertebroplasty. AJR 182:319-322 Chen H-L, Wong C-S, Ho S-T, et al. (2002) A lethal pulmonary embolism during percutaneous vertebroplasty. Anesth Analg 95:1060-1062 Cohen JE, Lylyk P, et. al. (2004) Percutaneous vertebroplasty: technique and results in 192 procedures. Neurol Res. 26(1):41-49 Cortet B, Cotton A, Boutry N, et al. (1997) Percutaneous vertebroplasty in patients with osteolytic metastases or multiple myeloma. Rev Rhum 64:177-183 Cortet B, Cotton A, Boutry N, et al. (1999) Percutaneous vertebroplasty in the treatment of osteoporotic vertebral compression fractures: An open prospective study. J Rheumatol 26:2222-2228 Cotten A, Dewatre F, Cortet B, et al. (1996) Percutaneous vertebroplasty for osteolytic metastases and myeloma: Effects of the percentage of lesion filling and the leakage of methyl methacrylate at clinical follow-up. Radiology 200:525-530 Cotten A, Boutry N, Cortet B, et al. (1998) Percutaneous vertebroplasty: State of the art. Radiographics 18(2):311-20; discussion 320-323. 18:311-320 Coumans J-VC, Reinhardt M-K, Lieberman I (2003) Kyphoplasty for vertebral compression fractures: 1-year clinical outcomes from a prospective study. J Neurosurg (Spine 1) 99:44-50 Crandall D, et al. (2004) Acute versus chronic vertebral compression fractures treated with kyphoplasty: Early results. Spine J 4(4):418-424 Cyteval C, Sarrabere MPB, Roux JO, et al. (1999) Acute osteoporotic vertebral collapse: Open study on percutaneous injection of acrylic surgical cement in 20 patients. Am J Roentgenology 173:1685-1690 Debussche-Depriester C, Deramond H, Fardellone P, et al. (1991) Percutaneous vertebroplasty with acrylic cement in the treatment of osteoporotic vertebral crush fracture syndrome. Neuroradiology 33 [Suppl]:149-152 Deramond H, Depriester C, Galibert P, et al. (1998) Percutaneous vertebroplasty with polymethylmethacrylate. Technique, indications, and results. Radiol Clin North Am 36:533-546 Procedure-Related Complication Rates: Literature Review References

Procedure-Related Complication Rates: Literature Review References Diamond TH, Champion B, Clark WA (2003) Management of acute osteoporotic vertebral fractures: A nonrandomized trial comparing percutaneous vertebroplasty with conservative therapy. Excerpta Medica Donovan MA, et al. (2004) Multiple adjacent vertebral fractures after kyphoplasty in a patient with steroid-induced osteoporosis. J Bone Miner Res 19(5:712-713) Dudeney S, Lieberman IH, Reinhardt M-K, et al. (2002) Kyphoplasty in the treatment of osteolytic vertebral compression fractures as a result of multiple myeloma. J Clin Oncol 20:2382-2387 Evans AJ, Jensen ME, Kip KE, et al. (2003) Vertebral compression fractures: Pain reduction and improvement in functional mobility after percutaneous polymethylmethacrylate vertebroplasty - retrospective report of 245 cases. Radiology 226:366-372 Fourney DR, Schomer DF, Nader R, et al. (2003) Percutaneous vertebroplasty and kyphoplasty for painful vertebral body fractures in cancer patients. J Neurosurg (Spine 1) 98:21-30 Galibert P, Deramond H, Rosat P, et al. (1987) A preliminary note on the treatment of vertebral angiomas by percutaneous vertebroplasty with acrylic cement. Neurosurg 33:166-168 Gangi A, Dietemann JL, Guth S, et al. (1999) Computed tomography (ct) and fluoroscopy-guided vertebroplasty: Results and complications in 187 patients. Sem Intervent Radiol 16:137-142 Garfin SR, Yuan HA, Reiley MA (2001) New technologies in spine: Kyphoplasty and vertebroplasty for the treatment of painful osteoporotic compression fractures. Spine 26:1511-1515 Gaughen JR, Jensen ME, Schweickert PA, et al. (2002a) Lack of preoperative spinous process tenderness does not affect clinical success of percutaneous vertebroplasty. J Vasc Interv Radiol 13:1135-1138 Gaughen JR, Jensen ME, Schweickert PA, et al. (2002b) Relevance of antecedent venography in percutaneous vertebroplasty for the treatment of osteoporotic compression fractures. Am J Neuroradiol 23:594-600 Grados F, Depriester C, Cayrolle G, et al. (2000) Long-term observation of vertebral osteoporotic fractures treated by percutaneous vertebroplasty. Rheumatology 39:1410-1414 Harrington KD (2001) Major neurological complications following percutaneous vertebroplasty with polymethylmethacrylate. J Bone Joint Surg 83-A:1070-1073 Heini PF, Walchli B, Berlemann U (2000) Percutaneous transpedicular vertebroplasty with PMMA: Operative technique and early results--a prospective study for the treatment of osteoporotic compression fractures. Eur Spine J 9:445-450 Hodler J, Peck D, Gilula LA (2003) Midterm outcome after vertebroplasty: Predictive value of technical and patient-related factors. Radiology 227:662-668 Hsiang J (2003) An unconventional indication for open kyphoplasty. Spine J 3(6):520-523 Jang J-S, Lee S-H, Jung S-K (2002) Pulmonary embolism of polymethylmethacrylate after percutaneous vertebroplasty. A report of three cases. Spine 27:E416-E418 Jang J-S, Kim D-Y, Lee S-H (2003) Efficacy of percutaneous vertebroplasty in the treatment of intravertebral pseudarthrosis associated with noninfected avascular necrosis of the vertebral body. Spine 28:1588-1592

Jensen ME, Evans AJ, Mathis JM, et al. (1997) Percutaneous polymethylmethacrylate vertebroplasty in the treatment of osteoporotic vertebral body compression fractures: Technical aspects. Am J Neuroradiol 18:1897-1904 Kallmes DF, Schweickert PA, Marx WF, et al. (2002) Vertebroplasty in the mid- and upper thoracic spine. Am J Neuroradiol 23:1117-1120 Kaemmerlen P, Thiesse P, Jonas P, et al. (1989) Percutaneous injection of orthopedic cement in metastatic vertebral lesions. N Engl J Med 321:121 Kelekis AD, Martin JB, Somon T, et al. (2003) Radicular pain after vertebroplasty. Spine 28:E265-E269 Kim A, Jensen ME, Dion JE, et al. (2002) Unilateral transpedicular percutaneous vertebroplasty: Initial experience. Radiology 222:737-741 Komp, et al. (2004) Minimally invasive therapy for functionally unstable osteoporotic vertebral fractures by means of kyphoplasty. Prospective comparative study of 19 surgically and 1 conservatively related patients. J Miner Stoffwechs 11(Suppl 1):13-16 (German) Kyphon U.S. Multicenter Prospective Single Arm Study. Data on file at Kyphon Inc. Lane JM, Johnson CE, Khan SN, et al. (2002) Minimally invasive options for the treatment of osteoporotic vertebral compression fractures. Orthop Clin N Am 33:431-438 Ledlie J, Renfro M (2003) Balloon kyphoplasty: One-year outcomes in vertebral body height restoration, chronic pain, and activity levels. J Neurosurg (Spine 1) 98:36-42 Lee B-J, Lee S-R, Yoo T-Y (2002) Paraplegia as a complication of percutaneous vertebroplasty with polymethylmethacrylate. Spine 27:E419-E422 Lieberman IH, Dudeney S, Reinhardt M-K, et al. (2001) Initial outcome and efficacy of "kyphoplasty" in the treatment of painful osteoporotic vertebral compression fractures. Spine 26:1631-1638 Lieberman IH, Reinhardt MK (2003) Vertebroplasty and Kyphoplasty for Osteolytic Vertebral Collapse. Clinical Orthopedics and Related Research No. 415S:S176-S186 Martin JB, Jean B, Sugiu K, et al. (1999) Vertebroplasty: Clinical experience and follow-up results. Bone 25:11S-15S Martin JB, Wetzel, SG, et al. (2003) Percutaneous vertebroplasty in metastatic disease: Transpedicular access and treatment of lysed pedicles – initial experience. Radiology 229:593-597 Masala S, et al. (2004) Percutaneous kyphoplasty: Indications and technique in the treatment of vertebral fractures from myeloma. Tumori 90(1):22-26 McGraw JK, Heatwolde E, et al. (2001) Predictive value of intraosseous venography before percutaneous vertebroplasty. J Vasc Interv Radiol 12:149-153 McGraw JK, Lippert JA, Minkus KD, et al. (2002) Prospective evaluation of pain relief in 100 patients undergoing percutaneous vertebroplasty McKiernan F, Jensen R, Faciszewski T (2003) The dynamic mobility of vertebral compression fractures. J Bone Miner Res 18:24-29 Moreland D, Landi M, et al. (2001) Vertebroplasty: Techniques to avoid complications. Spine J:66-71 Mousavi P, Roth S, Finkelstein J, et al. (2003) Volumetric quantification of cement leakage following percutaneous vertebroplasty in metastatic and osteoporotic vertebrae. J Neurosurg (Spine 1) 99:56-59 Procedure-Related Complication Rates: Literature Review References

Ortiz AO, et al; (2002) Kyphoplasty. Tech Vasc Interv Radiol 5(4):239-249 Padovani B, Kasriel O, Brunner P, et al. (1999) Pulmonary embolism caused by acrylic cement: A rare complication of percutaneous vertebroplasty. Am J Neuroradiol 20:375-377 Patel JG, Singh SK, et al. (2001) Percutaneous vertebroplasty: Minimally invasive procedures for vertebral fracture. Pain Med 2(3):247 Perez-Higueras A, Alvarez L, Rossi RE, et al. (2002) Percutaneous vertebroplasty: Long-term clinical and radiological outcome. Neuroradiology 44:950-954 Peh WCG, Gilula LA, Peck DD (2002) Percutaneous vertebroplasty for severe osteoporotic vertebral body compression fractures. Radiology 223:121-126 Peh WCG, Gelbart MS, Gilula LA, et al. (2003) Percutaneous vertebroplasty: Treatment of painful vertebral compression fractures with intraosseous vacuum phenomena. Am J Roentgenology 180:1411-1417 Phillips F, Wetzel F, Lieberman IH, et al. (2002) An in vivo comparison of the potential for extravertebral cement leakage after vertebroplasty and kyphoplasty. Spine 27:2173-2179 Phillips F, Campbell-Hupp M, McNally T, et al. (2003) Early radiographic and clinical results of balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures. Spine 28:2260-2265 Ryu KS, Park CK, Kim MC, et al. (2002) Dose-dependent epidural leakage of polymethylmethacrylate after percutaneous vertebroplasty in patients with osteoporotic vertebral compression fractures. J Neurosurg (Spine 1) 96:56-61 Rhyne A, et al. (2004) Kyphoplasty: Report of eighty-two thoracolumbar osteoporotic vertebral fractures. J Orthop Trauma 18(5):294-299 Scroop R, Eskridge J, Britz G (2002) Paradoxical cerebral arterial embolization of cement during intraoperative vertebroplasty: Case report. Am J Neuroradiol 23:868-870 Shapiro SA, Abel T, Purvines S (2003) Surgical removal of epidural and intradural polymethylmethacrylate extravasation complicating percutaneous vertebroplasty for an osteoporotic lumbar compression fracture. J Neurosurg (Spine 1) 98:90-92 Stricker K, Orler R, et al. (2004) Severe hypercapnia due to pulmonary embolism of polymethylmethacrylate during vertebroplasty. Anesth Analg 98:1184-6 Theodorou DJ, Theodorou SJ, Duncan TD, et al. (2002) Percutaneous balloon kyphoplasty for the correction of spinal deformity in painful vertebral body compression fractures. J Clin Imag 26:1-5 Togawa D, Bauer H, Lieberman IH, et al. (2003) Histologic evaluation of human vertebral bodies after vertebral augmentation with polymethyl methacrylate. Spine 28:1521-1527 Tozzi P, Abdelmoumene Y, Corno AF, et al. (2002) Management of pulmonary embolism during acrylic vertebroplasty. Ann Thorac Surg 74:1706-1708 Tsou IYY, Goh PYT, Peh WCG, et al. (2002) Percutaneous vertebroplasty in the management of osteoporotic vertebral compression fractures: Initial experience. Ann Acad Med Singapore 31:15-20 Uppin A, Hirsch J, Centenera L, et al. (2003) Occurrence of new vertebral body fracture after percutaneous vertebroplasty in patients with osteoporosis. Radiology 226:119-124 Procedure-Related Complication Rates: Literature Review References

Vasconcelos C, Gailloud P, Martin JB, et al. (2001) Transient arterial hypotension induced by polymethylmethacrylate injection during percutaneous vertebroplasty. J Vasc Interv Radiol 12:1001-1002 Vasconcelos C, Gailloud P, Beauchamp NJ, et al. (2002) Is percutaneous vertebroplasty without pretreatment venography safe? Evaluation of 205 consecutive procedures. Am J Neuroradiol 23:913-917 Voggenreiter, et al. (2004) Treatment results of the kyphoplasty balloon technique. MedReview Jan. 2004 (German) Wenger M, Markwalder TM (1999) Surgically controlled transpedicular methyl methacrylate vertebroplasty with fluoroscopic guidance. Acta Neurochirurgica 141:625-631 Weill A, Chiras J, Simon JM, et al. (1996) Spinal metastases: Indications for and results of percutaneous injection of acrylic surgical cement. Radiology 199:241-247 Wilhelm, et al. (2003) Preliminary experience with balloon kyphoplasty for the treatment of painful osteoporotic compression fractures. Fortschr Rontgenstr 175:1690-1696 Winking M, Stahl JP, et al. (2004) Treatment of pain from osteoporotic vertebral collapse by percutaneous PMMA vertebroplasty. Acta Neurochir (Wien) 146:469-476 Wong W, Reiley MA, Garfin S (2000) Vertebroplasty/kyphoplasty. J Women's Imag 2:117-124 Yeom JS, Kim WJ, Choy WS, et al. (2003) Leakage of cement in percutaneous transpedicular vertebroplasty for painful osteoporotic compression fractures. J Bone Joint Surg 85-B:83-89 Yoo KY, Jeong SW, et al. (2004) Acute respiratory distress syndrome associated with pulmonary cement embolism following percutaneous vertebroplasty with polymethylmethacrylate. SPINE (29)14:E294-E297 Yu SW, Lee PC, et al. (2004) Vertebroplasty for the treatment of osteoporotic compression spinal fracture: Comparison of remedial action at different stages of injury. J Trauma 56:629-632 Zoarski GH, Sno P, Olan WJ, et al. (2002) Percutaneous vertebroplasty for osteoporotic compression fractures: Quantitative prospective evaluation of long-term outcomes. J Vasc Interv Radiol 13:139-148 Procedure-Related Complication Rates: Literature Review References

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