PP209 Analysis Of The Efficacy And Safety Of Robotic Spinal Surgery

2021 ◽  
Vol 37 (S1) ◽  
pp. 27-27
Author(s):  
María del Mar Polo-deSantos ◽  
Setefilla Luengo-Matos ◽  
Ana Isabel Hijas-Gómez ◽  
Esther Elena García-Carpintero ◽  
Luis María Sánchez-Gómez
Keyword(s):  
Hospital Stay ◽  
Spinal Fusion ◽  
Meta Analysis ◽  
Pedicle Screws ◽  
Guidance System ◽  
Spinal Diseases ◽  
Main Diagnosis ◽  
Efficacy And Safety ◽  
Lower Radiation Dose ◽  
Safety Studies

IntroductionRobotic surgery (RS) can offer benefits compared to freehand surgery (FS) in the treatment of patients with spinal diseases. The aim of this study was to assess efficacy and safety of RS versus FS in spinal fusion. The outcomes considered were accuracy in the placement of pedicle screws, surgical times, hospital stay, exposure to radiation, and complications.MethodsA systematic review and meta-analysis were performed by researchers at the Instituto de Salud Carlos III (ISCIII). Studies published until June 2019 in the English, Spanish, or French languages were retrieved. The data analyses and risk of bias assessments were undertaken using RevMan 5.3.ResultsEight randomized controlled trials including 610 patients (RS: 308, FS: 302) were found. The mean age of the patients ranged from 56 to 68 years in the FS group and from 55 to 68 years in the RS group. The percentage of women included ranged from 46 to 73 percent undergoing FS and from 33 to 70 percent undergoing RS. The main diagnosis was degenerative spine disease. The number of screws implanted ranged from 22 to 584 for FS and 23 to 532 for RS. The robots used were the SpineAssist and Renaissance Guidance System (Mazor Robotics, Ltd) and the TiRobot® Orthopaedic Robotic System (Beijing Tinavi Medical Technologies Co., Ltd). Pedicle screw placement within the safety zone (Grades A and B on the Gertzbein and Robbins scale) ranged from 93 to 100 percent in FS and from 85 to 100 percent in RS (relative risk 1.0, 95% confidence interval [CI] 0.99–1.03; p = 0.36) (I2=75%; p = 0.0005). Regarding intervention time, the meta-analysis showed a mean difference (MD) of 15.2 minutes (95% CI 5.35–25.05; p = 0.002) (I2 = 0%; p = 0.39) in favor of FS. The MD in hospital stay was 0.36 days (95% CI -1.03–0.31; p = 0.30) (I2 = 62%; p = 0.07), which was not statistically significant. Contradictory results were found for fluoroscopy time, although RS was associated with a lower radiation dose than FS (p < 0.05). In relation to safety, studies only reported on rates of surgical revision, which ranged from 0 to 2 after FS and from 0 to 10 after RS. The risk or bias was unclear in most studies.ConclusionsWe found no conclusive results suggesting benefits for spinal fusion using RS compared with FS. Further research with adequate selection of patients, type of robot, and comparator is needed.

scholarly journals Efficacy and safety of abdominal paracentesis drainage on patients with acute pancreatitis: a systematic review and meta-analysis

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e045031
Author(s):  
Zongqing Lu ◽  
Xingxing Zhu ◽  
Tianfeng Hua ◽  
Jin Zhang ◽  
Wenyan Xiao ◽  
...  
Keyword(s):  
Systematic Review ◽  
Acute Pancreatitis ◽  
Cohort Studies ◽  
Hospital Stay ◽  
Meta Analysis ◽  
Length Of Hospital Stay ◽  
Infectious Complications ◽  
Efficacy And Safety ◽  
All Cause Mortality ◽  
Abdominal Paracentesis

ObjectivesTo conduct a systematic review and meta-analysis of the efficacy and safety of abdominal paracentesis drainage (APD) in patients with acute pancreatitis (AP) when compared with conventional ‘step-up’ strategy based on percutaneous catheter drainage (PCD).DesignSystematic review and meta-analysis.MethodsPubMed, EMBASE, Cochrane Library, MEDLINE (OVID), China National Knowledge Infrastructure and Wanfang Database were electronically searched to collect cohort studies and randomised controlled trials (RCTs) from inception to 25 July 2020. Studies related to comparing APD with conventional ‘step-up’ strategy based on PCD were included.OutcomesThe primary outcome was all-cause mortality. The secondary outcomes were the rate of organ dysfunction, infectious complications, hospitalisation expenses and length of hospital stay.ResultsFive cohort studies and three RCTs were included in the analysis. Compared with the conventional ‘step-up’ method, pooled results suggested APD significantly decreased all-cause mortality during hospitalisation (cohort studies: OR 0.48, 95% CI 0.26 to 0.89 and p=0.02), length of hospital stay (cohort studies: standard mean difference (SMD) −0.31, 95% CI −0.53 to –0.10 and p=0.005; RCTs: SMD −0.45, 95% CI −0.64 to –0.26 and p<0.001) and hospitalisation expenses (cohort studies: SMD −2.49, 95% CI −4.46 to –0.51 and p<0.001; RCTs: SMD −0.67, 95% CI −0.89 to –0.44 and p<0.001). There was no evidence to prove that APD was associated with a higher incidence of infectious complications. However, the incidence of organ dysfunction between cohort studies and RCTs subgroup slightly differed (cohort studies: OR 0.66, 95% CI 0.34 to 1.28 and p=0.22; RCTs: OR 0.58, 95% CI 0.35 to 0.98 and p=0.04).ConclusionsThe findings suggest that early application of APD in patients with AP is associated with reduced all-cause mortality, expenses during hospitalisation and the length of stay compared with the ‘step-up’ strategy without significantly increasing the risk of infectious complications. These results must be interpreted with caution because of the limited number of included studies as well as a larger dependence on observational trials.PROSPERO registration numberCRD42020168537.

scholarly journals Alternative Pedicle Screw Design via Biomechanical Evaluation

2020 ◽  
Vol 10 (14) ◽  
pp. 4746 ◽  
Author(s):  
Jiwoon Kwon ◽  
Myung Heon Ha ◽  
Moon Gu Lee
Keyword(s):  
Spinal Fusion ◽  
Pedicle Screw ◽  
Bending Strength ◽  
Pedicle Screws ◽  
The Elderly ◽  
Spinal Diseases ◽  
Fusion Surgery ◽  
Spinal Fusion Surgery ◽  
Screw Design ◽  
Experimental Apparatus

With the recent increase in the elderly population, many people suffer from spinal diseases, and, accordingly, spinal fusion surgery using pedicle screws has been widely applied to treat them. However, most research on pedicle screw design has been focused on the test results rather than the behavior of the screws and vertebrae. In this study, a design platform with a series of biomechanical tests and analyses were presented for pedicle screw improvement and evaluation. The platform was then applied to an alternative hybrid screw design with quadruple and double threads. An experimental apparatus was developed to investigate the bending strength of the screw, and several tests were performed based on the ASTM F1717 standard. In the experiments, it was confirmed that the alternative pedicle screw has the highest bending strength. To examine the stress distribution of pedicle screws, finite element models were established, through which it was found that the proposed pedicle screw has sufficient mechanical safety to make it acceptable for spinal fusion treatment. Finally, we conclude that the platform has good potential for the design and evaluation of pedicle screws, and the alternative dual screw design is one of the best options for spinal fusion surgery.

Safety and efficacy of direct acting oral anticoagulants and vitamin K antagonists in nonvalvular atrial fibrillation – a network meta-analysis of real-world data

VASA ◽  
2019 ◽  
Vol 48 (2) ◽  
pp. 134-147 ◽  
Author(s):  
Mirko Hirschl ◽  
Michael Kundi
Keyword(s):  
Real World ◽  
Meta Analysis ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Efficacy And Safety ◽  
Nonvalvular Atrial Fibrillation ◽  
Real World Data ◽  
Hazard Ratios ◽  
Direct Acting ◽  
Event Rates

Abstract. Background: In randomized controlled trials (RCTs) direct acting oral anticoagulants (DOACs) showed a superior risk-benefit profile in comparison to vitamin K antagonists (VKAs) for patients with nonvalvular atrial fibrillation. Patients enrolled in such studies do not necessarily reflect the whole target population treated in real-world practice. Materials and methods: By a systematic literature search, 88 studies including 3,351,628 patients providing over 2.9 million patient-years of follow-up were identified. Hazard ratios and event-rates for the main efficacy and safety outcomes were extracted and the results for DOACs and VKAs combined by network meta-analysis. In addition, meta-regression was performed to identify factors responsible for heterogeneity across studies. Results: For stroke and systemic embolism as well as for major bleeding and intracranial bleeding real-world studies gave virtually the same result as RCTs with higher efficacy and lower major bleeding risk (for dabigatran and apixaban) and lower risk of intracranial bleeding (all DOACs) compared to VKAs. Results for gastrointestinal bleeding were consistently better for DOACs and hazard ratios of myocardial infarction were significantly lower in real-world for dabigatran and apixaban compared to RCTs. By a ranking analysis we found that apixaban is the safest anticoagulant drug, while rivaroxaban closely followed by dabigatran are the most efficacious. Risk of bias and heterogeneity was assessed and had little impact on the overall results. Analysis of effect modification could guide the clinical decision as no single DOAC was superior/inferior to the others under all conditions. Conclusions: DOACs were at least as efficacious as VKAs. In terms of safety endpoints, DOACs performed better under real-world conditions than in RCTs. The current real-world data showed that differences in efficacy and safety, despite generally low event rates, exist between DOACs. Knowledge about these differences in performance can contribute to a more personalized medicine.

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