Effect of prophylactic infusion of norepinephrine on the prevention of hypotension during vertebroplasty: a randomized clinical trial.

BACKGROUND: Transient hypotension is a common occurrence during the implantation of bone cement. This placebo-controlled randomized clinical trial study investigated the effect of prophylactic infusion of norepinephrine on the incidence of hypotension in senior patients who underwent vertebroplasty. METHODS: The trial recruited patients who were greater than or equal to 65 years of age, had an American Society of Anesthesiologist physical status classification of I to III, and underwent vertebroplasty from August 2020 to August 2021 at the Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine in China. The patients were randomly grouped according to whether they received either a norepinephrine infusion of 0.05 µg/kg/min or an equivalent volume of saline 10 min before implantation of bone cement. Intraoperative hemodynamics were monitored continuously by the MostCare system at the following 7 time points: 10 min before implantation of bone cement and immediately, 30 s, 1, 3, 5, and 10 min after implantation of bone cement. We also recorded the number of hypotensive episodes and the total number of vasopressors after implantation of bone cement. Multivariable logistic regression was used to assess the risk factors associated with hypotension after implantation of bone cement. RESULTS: A total of 63 patients were randomized to the control group (n = 31; median [IQR] age, 74 [69-79] years) and the norepinephrine group (n = 32; median [IQR] age, 75 [71-79] years). The incidence of hypotension in the norepinephrine group was significantly lower than that in the control group after implantation of bone cement (12.5% vs. 45.2%; relative risk [RR], 3.61 [95% CI, 1.13-15.07]; P = 0.005). Moreover, the median (IQR) number of hypotensive episodes (0 [0-0] vs. 0 [0-2]; P = 0.005) and the total number of vasopressors (0 [0-0] vs. 0 [0-1]; P = 0.004) in the norepinephrine group were significantly lower than those in the control group. Furthermore, compared with the baseline, the MAP significantly decreased at 1 min (P = 0.007) and 3 min (P < 0.001) after bone cement implantation in the control group. However, the MAP at 3 min in the norepinephrine group was significantly higher than that in the control group (P < 0.001). The incidence of complications was not different between the groups. In multivariable logistic regression, the FRAIL score (OR, 2.29; 95% CI, 1.21-4.31) was identified as a risk factor associated with hypotension. CONCLUSION: Prophylactic infusion of norepinephrine before bone cement implantation can stabilize hemodynamics and reduce the incidence of hypotension after implantation of bone cement.

Jintiange capsule may have a positive effect on pain relief and functional activity in OVCF patients with PVA: A meta-analysis of randomized control trials.

BACKGROUND: This study aims to systematically evaluate the clinical efficacy and adverse reactions associated with Jintiange capsule (JTG capsule)-assisted percutaneous vertebral augmentation (PVA) in the treatment of osteoporotic vertebral compression fracture (OVCF). METHODS: A comprehensive search was conducted across multiple databases including PubMed, Cochrane Library, EMBASE, Web of Science Database, China Biomedical Database, China VIP Network, China National Knowledge Infrastructure, Wanfang, and VIP Chinese Journal databases until June 1, 2022. Manual searches were also performed in relevant journals. Randomized controlled trials investigating the efficacy of JTG capsule-assisted PVA in the treatment of OVCF were identified and selected for inclusion. The quality of the included studies was assessed using the Cochrane risk bias assessment tool and Jadad scale. Meta-analysis was conducted using Stata MP18 software. RESULTS: A total of 138 literatures were retrieved, and 12 RCTS were finally included after screening, involving 1099 patients. Overall, the quality of the included literature was low, and all the included literatures were randomized controlled experiments, among which 9 were grouped by random number table, and 3 did not specify the random assignment plan. The total effective rate of the experimental group was higher than that of the control group (relative ratio: 1.19, 95% confidence interval: 1.11, 1.26, P = .868, I2 = 0%). The heterogeneity of visual analog score, Oswestry disability index, bone mineral density (BMD) of lumbar vertebrae, BMD of femoral neck and bone-γ-carboxyglutamic acid-containing protein was high. The reasons for the high heterogeneity were the age of patients, the follow-up time and the small sample size. There is publication bias in visual analog score, Oswestry disability index scores, and lumbar spine bone mineral density, and we believe that publication bias may be related to selective reporting of positive results by the authors and selective publication of positive results by the publishers. CONCLUSION: JTG capsule has demonstrated promising outcomes in alleviating the pain experienced by OVCF patients following PVP. Additionally, it has shown efficacy in enhancing postoperative lumbar and back function. Furthermore, JTG capsule has been associated with improvements in postoperative vertebral BMD and serum bone-γ-carboxyglutamic acid-containing protein levels. These findings suggest that JTG capsule could potentially serve as a viable adjunctive treatment option for managing osteoporosis following PVA.

Pulmonary embolism and intracardiac foreign bodies caused by bone cement leakage: a case report and literature review.

Percutaneous vertebroplasty (PVP) is a surgical procedure that involves injecting polymethylmethacrylate (PMMA) bone cement into the diseased vertebrae to rapidly relieve pain and strengthen the vertebrae. We reported a 73-year-old patient who underwent percutaneous vertebroplasty (PVP) surgery for thoracolumbar vertebral compression fracture. After the surgery, the patient experienced symptoms such as chest tightness and dyspnea. Further examination revealed multiple high-density foreign bodies in the blood vessels/heart and concomitant multi-organ dysfunction. It was considered that the multi-organ embolism was caused by bone cement leakage. The patient improved after undergoing surgical treatment and anticoagulant therapy.

Comparative analysis of percutaneous vertebroplasty and kyphoplasty in the treatment of Stage III Kummell's disease without neurological symptoms: a retrospective study.

OBJECTIVE: This study analyzes the safety and efficacy of percutaneous vertebroplasty (PVP) and percutaneous kyphoplasty (PKP) treatments for Stage III Kummell's disease without neurological symptoms, comparing the advantages and disadvantages of these two minimally invasive surgical methods. METHODS: A retrospective analysis was conducted on 53 patients with non-neurological Stage III Kummell's disease treated with PVP and PKP at our hospital from December 2018 to January 2023. Patients were divided into PVP (25 cases) and PKP (28 cases) groups based on the surgical method. There were no significant differences in general preoperative data between the two groups (all p > 0.05), ensuring comparability. The study compared surgical duration, volume of bone cement injected, distribution pattern of bone cement, rate of bone cement leakage, and preoperative, postoperative, and final follow-up scores of Visual analogue scale(VAS) and Oswestry disability index(ODI). Additionally, relative anterior height of the injured vertebrae, and Cobb angle of deformity, along with their changes at preoperative, postoperative, and final follow-up stages were calculated and analyzed. RESULTS: No significant preoperative differences were observed between the groups (p > 0.05). The PKP group had longer surgeries, higher cement volumes (p < 0.001), and lower leakage rates (p < 0.05), with primarily chunky cement distributions versus mixed distributions in the PVP group. No complications other than cement leakage occurred. VAS and ODI scores showed no significant changes at various time points (p > 0.05) but improved significantly from preoperative (p < 0.001). Both groups saw improved vertebral heights and Cobb angles post-surgery (p < 0.05), with more significant improvements in the PKP group (p < 0.05). Over time, both groups experienced gradual vertebral height loss and increased Cobb angles, more pronounced in the PKP group (p < 0.05). At the final follow-up, there were no statistical differences in vertebral height and Cobb angle between the two groups (p > 0.05). CONCLUSION: The study evaluates the safety and efficacy of PVP and PKP for Stage III Kummell's disease without neurological symptoms, comparing the merits of both minimally invasive techniques.

Incidence and risk factors of adjacent vertebral fracture after percutaneous vertebroplasty or kyphoplasty in postmenopausal women: a retrospective study.

Adjacent vertebral fracture (AVF) is a serious complication of percutaneous vertebroplasty (PVP) or kyphoplasty (PKP) for osteoporotic vertebral compression fracture (OVCF). This study aimed to explore the incidence and risk factors of AVF following PVP or PKP in postmenopausal women. The incidence of AVF was determined by spinal radiographic examinations. The potential risk factors of AVF were identified by univariate analysis, followed by multivariate logistic regression analyses to determine the independent risk factors. In total, 674 postmenopausal women who were treated with PVP or PKP from December 2019 to February 2022 were enrolled in the study. Among them, 58 (8.61%) women experienced an AVF following PVP or PKP. After adjusting for confounding factors, BMI (OR [95% CI] 0.863 [0.781-0.952]; p = 0.003), previous history of OVCF (OR [95% CI] 1.931 [1.044-3.571]; p = 0.036), and Hounsfield unit (HU) value (OR [95% CI] 0.979 [0.967-0.990]; p < 0.001) were found to be independent risk factors of AVF following PVP or PKP in postmenopausal women. The ROC analysis revealed that the BMI and HU thresholds were 21.43 and 65.15, respectively. In conclusion, the incidence of AVF was 8.61%. BMI, previous history of OVCF and HU value were independent risk factors of AVF following PVP or PKP in postmenopausal women.

Can We Rely on Prophylactic Two-Level Vertebral Cement Augmentation in Long-Segment Adult Spinal Deformity Surgery to Reduce the Incidence of Proximal Junctional Complications?

Background and Objectives: Proximal junctional kyphosis (PJK) and failure (PJF), the most prevalent complications following long-segment thoracolumbar fusions for adult spinal deformity (ASD), remain lacking in defined preventive measures. We studied whether one of the previously reported strategies with successful results-a prophylactic augmentation of the uppermost instrumented vertebra (UIV) and supra-adjacent vertebra to the UIV (UIV + 1) with polymethylmethacrylate (PMMA)-could also serve as a preventive measure of PJK/PJF in minimally invasive surgery (MIS). Materials and Methods: The study included 29 ASD patients who underwent a combination of minimally invasive lateral lumbar interbody fusion (MIS-LLIF) at L1-2 through L4-5, all-pedicle-screw instrumentation from the lower thoracic spine to the sacrum, S2-alar-iliac fixation, and two-level balloon-assisted PMMA vertebroplasty at the UIV and UIV + 1. Results: With a minimum 3-year follow-up, non-PJK/PJF group accounted for fifteen patients (52%), PJK for eight patients (28%), and PJF requiring surgical revision for six patients (21%). We had a total of seven patients with proximal junctional fracture, even though no patients showed implant/bone interface failure with screw pullout, probably through the effect of PMMA. In contrast to the PJK cohort, six PJF patients all had varying degrees of neurologic deficits from modified Frankel grade C to D3, which recovered to grades D3 and to grade D2 in three patients each, after a revision operation of proximal extension of instrumented fusion with or without neural decompression. None of the possible demographic and radiologic risk factors showed statistical differences between the non-PJK/PJF, PJK, and PJF groups. Conclusions: Compared with the traditional open surgical approach used in the previous studies with a positive result for the prophylactic two-level cement augmentation, the MIS procedures with substantial benefits to patients in terms of less access-related morbidity and less blood loss also provide a greater segmental stability, which, however, may have a negative effect on the development of PJK/PJF.

Space between bone cement and bony endplate can trigger higher incidence of augmented vertebral collapse: An in-silico study.

BACKGROUND: The pathogenesis of postoperative complications in patients with osteoporotic vertebral compressive fractures (OVCFs) undergoing percutaneous vertebroplasty (PVP) is multifaceted, with local biomechanical deterioration playing a pivotal role. Specifically, the disparity in stiffness between the bone cement and osteoporotic cancellous bone can precipitate interfacial stress concentrations, potentially leading to cement-augmented vertebral body collapse and clinical symptom recurrence. This study focuses on the biomechanical implications of the space between the bone cement and bony endplate (BEP), hypothesizing that this interface may be a critical locus for stress concentration and subsequent vertebral failure. METHODS: Leveraging a validated numerical model from our previous study, we examined the biomechanical impact of the cement-BEP interface in the L2 vertebral body post-PVP, simulated OVCF and PVP and constructed three distinct models: one with direct bone cement contact with both cranial and caudal BEPs, one with contact only with the caudal BEPs and one without contact with either BEP. Moreover, we assessed stress distribution across cranial and caudal BEPs under various loading conditions to describe the biomechanical outcomes associated with each model. RESULTS: A consistent trend was observed across all models: the interfaces between the bone cement and cancellous bone exhibited higher stress values under the majority of loading conditions compared to models with direct cement-BEP contact. The most significant difference was observed in the flexion loading condition compared to the mode with direct contact between BEP and cement. The maximum stress in models without direct contact increased by at least 30%. CONCLUSIONS: Our study reveals the biomechanical significance of interfacial stiffness differences at the cement-BEP junction, which can exacerbate local stress concentrations and predispose to augmented vertebral collapse. We recommend the strategic distribution of bone cement to encompass a broader contact area with the BEP for preventing biomechanical failure and subsequent vertebral collapse.

Safety and clinical efficacy of microwave ablation combined with percutaneous vertebroplasty in the treatment of multisegmental spinal metastases.

OBJECTIVE: To evaluate the safety and efficacy of microwave ablation (MWA) combined with percutaneous vertebroplasty (PVP) in the treatment of multisegmental (2-3 segments) osteolytic spinal metastases. MATERIALS AND METHODS: This study comprised a retrospective analysis of data from 20 patients with multisegmental (2-3 segments) osteolytic spinal metastases who received MWA combined with PVP. The visual analog scale (VAS) score, Oswestry Disability Index (ODI) score, Quality of Life Questionnaire-Bone Metastases 22 (QLQ-BM22), and local recurrence before and after the operation were measured. The occurrence of complications was observed to evaluate safety. RESULTS: All operations were completed successfully with no serious complications. Transient nerve injury occurred in two cases, but recovered after symptomatic treatment. The bone cement leakage rate was 13.9% (6/43). The mean baseline VAS scores were 7.25 ± 0.91 before treatment and 7.25 ± 0.91, 3.70 ± 1.12, 2.70 ± 0.73, 2.40 ± 0.68, 2.25 ± 0.71, and 2.70 ± 0.92 at 1 day, 1 week, 1, 3, and 6 months after treatment; all values were significantly lower (P < 0.001). The mean baseline ODI score decreased from 56.90 ± 9.74 before treatment to 41.90 ± 7.09, 38.10 ± 7.93, and 38.80 ± 10.59 at 1, 3, and 6 months after treatment, respectively; all values were significantly lower (P < 0.001). The average QLQ-BM22 baseline score decreased from 54.10 ± 5.36 before treatment to 44.65 ± 5.22, 43.05 ± 4.78, 42.30 ± 4.06, and 42.15 ± 5.47 at 1 week, 1, 3, and 6 months after treatment; all values were significantly lower (all P < 0.001). The postoperative survival time of all patients was >6 months. In three patients, four vertebral segments recurred 6 months after operation. CONCLUSION: MWA combined with PVP is a safe and effective treatment for multisegmental osteolytic vertebral metastases that can effectively relieve pain, improve spinal function, improve quality of life, and delay tumor progression. However, it is a long operation, necessitating good preoperative preparation and effective intraoperative pain relief measures.

[Vertebral fractures combined with prolonged activated partial prothrombin time: A case report].

With the development of modern medical standards, autoimmune diseases and their associated successive osteoporosis have received increasing attention in recent years. Patients with autoimmune diseases, due to the characteristics of the disease and the prolonged use of glucocorticoid hormone therapy, may affect the bone formation and bone absorption of the patient, followed by severe successive osteoporosis, thereby increasing the risk of osteoporotic vertebral fractures. Vertebral compression fractures of the spine are common fracture types in patients with osteoporotic fractures. Osteoporosis is a common complication after glucocorticoid therapy in patients with autoimmune diseases. Percutaneous vertebroplasty (PVP) and percutaneous kyphoplasty (PKP) are minimally invasive operation and are commonly used surgical methods for the treatment of osteoporotic vertebral compression fractures. However, due to the operation of spinal puncture during the operation, there are serious surgical risks such as bone cement leakage, spinal epidural hemorrhage, subdural hemorrhage, and subarachnoid hemorrhage in both PVP and PKP. As a result, it is necessary to evaluate the patient' s body before surgery carefully, especially in the case of blood coagulation. This article reports a case of autoimmune disease patient admitted to Peking University People' s Hospital due to lumbar 4 vertebral compression fracture combined with Sjögren' s syndrome. The patient' s preoperative examination showed that the activated partial thromboplastin time (APTT) was significantly prolonged. After completing the APTT extended screening experiment and lupus anticoagulant factor testing, the multi-disciplinary team (MDT) of Peking University People' s Hospital jointly discussed the conclusion that the patient' s test results were caused by an abnormal self-immunity anti-copulant lupus (LAC). Based on the results of the laboratory examination, the patient was considered to be diagnosed with combined antiphospholipid syndrome (APS). For such patients, compared with the patient' s tendency to bleed, we should pay more attention to the risk of high blood clotting in the lower limbs of the patient, pulmonary clots and so on. With timely anti-coagulation treatment, the patient safely passed the peripheral period and was successfully discharged from the hospital. Therefore, for patients with autoimmune diseases with prolonged APTT in the perioperative period, doctors need to carefully identify the actual cause and carry out targeted treatment in order to minimize the risk of surgical and perioperative complications and bring satisfactory treatment results to the patients.

What are the Risk Factors for Residual Pain After Percutaneous Vertebroplasty or Kyphoplasty? A Meta-Analysis.

BACKGROUND: Although many risk factors for residual pain following percutaneous vertebroplasty or kyphoplasty (PVP or PKP) have been reported in many studies, research methods and cohorts differ greatly. A previous meta-analysis identified patient- and operation-specific risk factors for residual pain. This study aimed to examine the available data and identify significant risk factors for residual pain after PVP or PKP. METHODS: PubMed, EMBASE, Web of Science, and the Chinese Wanfang Database were searched for relevant research in English and Chinese, and full-text publications including patients with and without residual pain were compared. Only studies presenting odds ratios from multivariate analysis of residual pain data were considered. To evaluate the impact of the results of the selected articles, Review Manager 5.4 was used. RESULTS: Twelve publications including a total of 3120 patients met the requirements. The meta-analysis examined 10 factors associated with residual pain and categorized them as either patient- or operation-associated factors. Thoracolumbar fascia injury, intravertebral vacuum cleft, depression, and number of fractured vertebrae were all significant patient-associated parameters for residual pain. Significant operation-associated risk factors included bone cement distribution and intraoperative facet joint injury. CONCLUSIONS: In this meta-analysis, we identified several significant risk factors for residual pain after PVP or PKP. These findings may be helpful for patient counseling and surgical planning.

Analysis of adjacent vertebral fracture after percutaneous vertebroplasty: do radiological or surgical features matter?

PURPOSE: To report the incidence and risk factors of adjacent vertebral fracture (AVF) after percutaneous vertebroplasty (PVP) in patients with osteoporotic vertebral compression fractures (OVCFs). We focused to investigate effect of radiological or surgical features on AVF. METHODS: All patients with OVCFs who were treated with PVP between January 2016 and December 2019 were retrospectively reviewed. Patients were followed up at least 12 months after procedure according to treatment protocol. AVF was defined as postoperatively recurrent intractable back pain and subsequently presence of fracture on magnetic resonance imaging (MRI) in adjacent levels. Clinical, radiological, and surgical factors potentially affecting occurrence of AVF were recorded and analyzed using univariate and multivariate analysis. RESULTS: Totally, 1077 patients with 1077 fractured vertebrae who underwent PVP were enrolled in the study, after inclusion and exclusion criteria were met. Mean follow-up time was 24.3 ± 11.9 months (range, 12-59 months). AVF was identified in 98 (9.1%) patients. Univariate analysis showed that seven significant factors related to AVF were older age, non-traumatic fracture, cortical disruption on anterior wall, cortical disruption on lateral wall, basivertebral foramen, type-B leakage and type-C leakage. In multivariate analysis, two clinical factors, older age (P = 0.031) and non-traumatic fracture (P = 0.002), were significantly associated with AVF. However, any radiological or surgical factor did not reach significance in final model analysis. CONCLUSIONS: Incidence of AVF after PVP in patients with OVCFs was 9.1% (98/1077). Older age and non-traumatic fracture were two clinical risk factors for AVF. Neither radiological nor surgical feature was significantly correlated with AVF.

Comparison of the Clinical Outcomes of Vesselplasty vs. Percutaneous Vertebroplasty for the Treatment of Neurologically Intact Osteoporotic Kümmell's Disease: A Retrospective Study.

Kummell's disease (KD) is a rare clinical complication of osteoporotic vertebral compression fractures (OVCFs). Minimally invasive surgery is an important way to treat KD. In this paper, we used Percutaneous Vertebroplasty (PVP) and Vesselplasty (VP) to treat KD. 125 patients with KD were admitted to our hospital. Among them, 89 patients received PVP and 36 received VP. All patients underwent operations successfully. VAS scores and ODI of both groups at each postoperative time point were lower than preoperatively. Postoperative Cobb angle of both groups postoperatively was lower than preoperatively (p < 0.05). The anterior height and ratio of vertebra compression of both groups postoperatively was lower than preoperatively (p < 0.05). Cement leakage occurred in 16 vertebrae (16/89) in PVP group and one (1/36) in VP group. Two patients suffered from transient paraplegia in PVP group immediately after operation. Adjacent vertebral fractures occurred in one patient in PVP group and one in VP group. Re-fracture of affected vertebra occurred in one patient in PVP group. Besides, four patients suffered from bone cement loosening in PVP group while one in VP group. Both PVP and VP play an important effect in pain relief and functional recovery for the treatment of KD. And VP is more effective than PVP in preventing cement leakage.