Temperature measurement during polymerization of bone cement in percutaneous vertebroplasty: an in vivo study in humans.

Aim of the study was to "in vivo" measure temperature, during percutaneous vertebroplasty (PV), within a vertebral body injected with different bone cements. According to the declaration of Helsinki, 22 women (60-80 years; mean, 75 years) with painful osteoporotic vertebral collapse underwent bilateral transpedicular PV on 22 lumbar vertebrae. Two 10-G vertebroplasty needles were introduced into the vertebra under digital fluoroscopy; a 16-G radiofrequency thermoablation needle (Starburst XL; RITA Medical System Inc., USA), carrying five thermocouples, was than coaxially inserted. Eleven different bone cements were injected and temperatures were measured every 30 s until temperatures dropped under 45 degrees C. After the thermocouple needle was withdrawn, bilateral PV was completed with cement injection through the vertebroplasty needle. Unpaired Student's t-tests, Kruskal-Wallis test, and Wilcoxon signed rank test were used to evaluate significant differences (p < 0.05) in peak temperatures, variations between cements, and clinical outcome. All procedures were completed without complications, achieving good clinical outcomes (p < 0.0001). Regarding average peak temperature, cements were divided into three groups: A (over 60 degrees C), B (from 50 degrees to 60 degrees C), and C (below 50 degrees C). Peak temperature in Group A (86.7 +/- 10.7 degrees C) was significantly higher (p = 0.0172) than that in Groups B (60.5 +/- 3.7 degrees C) and C (44.8 +/- 2.6 degrees C). The average of all thermocouples showed an extremely significant difference (p = 0.0002) between groups. None of the tested cements maintained a temperature >or=45 degrees C for more than 30 min. These data suggest that back-pain improvement is obtained not by thermal necrosis but by mechanical consolidation only. The relative necrotic thermal effect in vertebral metastases seems to confirm that analgesia must be considered the main intent of PV.

Percutaneous vertebroplasty and bone cement leakage: clinical experience with a new high-viscosity bone cement and delivery system for vertebral augmentation in benign and malignant compression fractures.

The aim of this study was to assess the feasibility of and venous leakage reduction in percutaneous vertebroplasty (PV) using a new high-viscosity bone cement (PMMA). PV has been used effectively for pain relief in osteoporotic and malignant vertebral fractures. Cement extrusion is a common problem and can lead to complications. Sixty patients (52 female; mean age, 72.2 +/- 7.2) suffering from osteoporosis (46), malignancy (12), and angiomas (2), divided into two groups (A and B), underwent PV on 190 vertebrae (86 dorsal, 104 lumbar). In Group A, PV with high-viscosity PMMA (Confidence, Disc-O-Tech, Israel) was used. This PMMA was injected by a proprietary delivery system, a hydraulic saline-filled screw injector. In Group B, a standard low-viscosity PMMA was used. Postprocedural CT was carried out to detect PMMA leakages and complications. Fisher's exact test and Wilcoxon rank test were used to assess significant differences (p < 0.05) in leakages and to evaluate the clinical outcome. PV was feasible, achieving good clinical outcome (p < 0.0001) without major complications. In Group A, postprocedural CT showed an asymptomatic leak in the venous structures of 8 of 98 (8.2%) treated vertebrae; a discoidal leak occurred in 6 of 98 (6.1%). In Group B, a venous leak was seen in 38 of 92 (41.3%) and a discoidal leak in 12 of 92 (13.0%). Reduction of venous leak obtained by high-viscosity PMMA was highly significant (p < 0.0001), whereas this result was not significant (p = 0.14) related to the disc. The high-viscosity PMMA system is safe and effective for clinical use, allowing a significant reduction of extravasation rate and, thus, leakage-related complications.

Postoperative liver dysfunction and future remnant liver: where is the limit? Results of a prospective study.

BACKGROUND: The future remnant liver (FRL) limit for safe major hepatectomy with low risk of postoperative liver failure has not yet been well defined. METHODS: Between April 2000 and September 2004, every patient scheduled for major hepatectomy in our institution underwent CT-volumetry of FRL. Patients with FRL <25% underwent portal vein embolization (PVE). Exclusion criteria were PVE, associated vascular resection and liver cirrhosis. The FRL was correlated with short-term results in patients with normal liver (group A) and those with impaired liver function secondary to neoadjuvant chemotherapy or cholestasis (bilirubin >2 mg/100 ml) (group B). Liver dysfunction was defined as both PT <50% and serum bilirubin level >5 mg/100 ml for three or more consecutive days. RESULTS: A total of 119 patients were analyzed, 72 in group A and 47 in group B. The FRL value was the only significant risk factor for postoperative liver dysfunction in the univariate and multivariate analysis (p = 0.009). The FRL did not correlate with postoperative mortality and morbidity. Bilirubin and prothrombin time (PT) on days 3 and 7 were significantly correlated to FRL in both groups. In group A, patients with postoperative liver dysfunction had a FRL<30% (3 versus 0; p = 0.005). According to receiving operator characteristic (ROC) curve analysis, a FRL value of 26.5% predicted postoperative liver dysfunction with 66.7% sensitivity, 97.1% specificity, 50% positive predictive value (PPV), and 98.5% negative predictive value (NPV). In group B, patients with postoperative liver dysfunction had a FRL <35% (4 versus 0; p = 0.027). According to ROC curve analysis, a FRL value of 31.05% predicted postoperative liver dysfunction with 75% sensitivity, 79.1% specificity, 25% PPV, and 97.1% NPV. CONCLUSIONS: Hepatectomy can be considered safe when FRL is >26.5% in patients with healthy liver and >31% in patients with impaired liver function.

Pain relief following percutaneous vertebroplasty: results of a series of 283 consecutive patients treated in a single institution.

The aim of this study was to assess if percutaneous vertebroplasty (PVP) could relieve back pain, reduce drug consumption, and improve the mobility of patients with metastases and vertebral compression fractures. From August 2002 to July 2004, 283 patients (216 females; mean age: 73.8 +/- 9.9 years) underwent PVP on 749 vertebrae. Pain was evaluated with the pain intensity numeric rating scale (PI-NRS) (0 = no pain; 10 = worst pain) before the procedure and at the end point in September 2004 (follow-up:1-24 months; median: 7 months). A reduction of at least two points of the PI-NRS score was considered clinically relevant. Two hundred four patients were available for evaluation at the end point. Overall results showed a reduction of the median pain score from 8 at baseline to 1 at the end point (p < 0.0001); a clinically relevant pain reduction was observed in 176/205 patients (86%); 89/147 patients (61%) gave up a brace support (p < 0.0001); and 117/190 patients (62%) gave up drug therapy. Results were similar in different subgroups stratified according to age, underlying pathology, number of fractured or treated vertebrae, and length of follow-up. This study adds evidence that PVP is effective in treating painful vertebral fractures. A significant reduction in drug assumption and significant mobility improvement can also be achieved.