Easily Created Prediction Model Using Automated Artificial Intelligence Framework (Prediction One, Sony Network Communications Inc., Tokyo, Japan) for Subarachnoid Hemorrhage Outcomes Treated by Coiling and Delayed Cerebral Ischemia
Introduction Reliable prediction models of subarachnoid hemorrhage (SAH) outcomes and delayed cerebral ischemia (DCI) are needed to decide the treatment strategy. Automated artificial intelligence (AutoAI) is attractive, but there are few reports on AutoAI-based models for SAH functional outcomes and DCI. We herein made models using an AutoAI framework, Prediction One (Sony Network Communications Inc., Tokyo, Japan), and compared it to other previous statistical prediction scores. Methods We used an open dataset of 298 SAH patients, who were with non-severe neurological grade and treated by coiling. Modified Rankin Scale 0-3 at six months was defined as a favorable functional outcome and DCI occurrence as another outcome. We randomly divided them into a 248-patient training dataset and a 50-patient test dataset. Prediction One made the model using training dataset with 5-fold cross-validation. We evaluated the model using the test dataset and compared the area under the curves (AUCs) of the created models. Those of the modified SAFIRE score and the Fisher computed tomography (CT) scale to predict the outcomes. Results The AUCs of the AutoAI-based models for functional outcome in the training and test dataset were 0.994 and 0.801, and those for the DCI occurrence were 0.969 and 0.650. AUCs for functional outcome calculated using modified SAFIRE score were 0.844 and 0.892. Those for the DCI occurrence calculated using the Fisher CT scale were 0.577 and 0.544. Conclusions We easily and quickly made AutoAI-based prediction models. The models' AUCs were not inferior to the previous prediction models despite the easiness.
Management of patients suffering from hemorrhagic intracranial metastases: Propositions to help the neurosurgeon in emergencies situations based on a literature review
INTRODUCTION Brain metastases are the most common intracranial neoplasm in adult patients, and one of the fearsome complications proves to be intratumoral hemorrhage. The neurosurgical management of patients harboring a bleeding brain metastasis is not fully established and there is still today an ongoing debate on the optimal management of these patients. The aim of this article is to provide the neurosurgeons with practical tools to assist in their decision-making process in the management of BMs. METHODS We conducted a literature review of the relevant Pubmed, Cochrane, and Google scholar-indexed articles published between 2000 and 2019. The following keywords were entered in the Pubmed search engine: [metastasis], [metastases], [brain metastases], [brain metastasis], [hemorrhage], [hematoma], [blood clot], [intracerebral hemorrhage], [intracranial hemorrhage]. The review was performed in accordance with the PRISMA recommendations. RESULTS Based on PubMed, Cochrane, and Google scholar, 459 articles were retained, 392 were then removed because of their non-adequacy with the topic and, 9 articles were removed because they were not written in English language. So, 58 articles were analyzed. Radiological evaluation is crucial, but few traps exist. The frequency of overall brain tumor-related with intracranial hematoma is 7.2%, with a higher frequency for secondary tumors. The local recurrence rate after resection of a hemorrhagic metastasis seems to be better probably because of an easier "en bloc" resection thanks to the hematoma. An atypical presentation is reported in up to 4% in patients with chronic or acute subdural hematoma. Patients with subarachnoid hemorrhage and epidural hematoma are rare. A clear-cut correlation between the incidence of bleeding event in brain mets and prior stereotactic radiosurgery was not established Conclusion: The current literature pertaining to the neurosurgical management of acute bleeding in brain metastasis is scant and the level of evidence remains low (experts 'opinions; class C). Herein we suggest a flowchart to assist in dealing with those difficult patients.
Is blood transfusion associated with an increased risk of infection among spine surgery patients?: A meta-analysis
BACKGROUND Blood transfusions are associated with many adverse outcomes among spine surgery patients, but it remains unclear whether perioperative blood transfusion during spine surgery and postoperative infection are related. Recently, many related cohort studies have been published on this topic. METHODS This study was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. The PubMed, Embase, and Cochrane Library databases were searched for eligible published studies. The Newcastle-Ottawa Scale (NOS) was used to assess the methodological quality of the studies, and a random-effects model was used to calculate the odds ratios (ORs) with 95% CIs. Sensitivity analyses were conducted to explore the source of heterogeneity. RESULTS The final analysis included 8 cohort studies with a total of 34,185 spine surgery patients. These studies were considered to be of high or moderate quality based on their NOS scores, which ranged from 5 to 9. Pooled estimates indicated that blood transfusion increased the infection rate (OR, 2.99; 95% CI, 1.95 to 4.59; I = 86%), which was consistent with the sensitivity analyses. CONCLUSIONS Our results suggest that perioperative blood transfusion is a risk factor for postoperative infection among spine surgery patients. Further study is necessary to identify other influencing factors and to establish the mechanism underlying this relationship. Additional measures may be needed to reduce unnecessary blood transfusions during spine surgery.
Efficacy and safety of minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label, blinded endpoint phase 3 trial
Lancet (London, England). 2019
BACKGROUND Acute stroke due to supratentorial intracerebral haemorrhage is associated with high morbidity and mortality. Open craniotomy haematoma evacuation has not been found to have any benefit in large randomised trials. We assessed whether minimally invasive catheter evacuation followed by thrombolysis (MISTIE), with the aim of decreasing clot size to 15 mL or less, would improve functional outcome in patients with intracerebral haemorrhage. METHODS MISTIE III was an open-label, blinded endpoint, phase 3 trial done at 78 hospitals in the USA, Canada, Europe, Australia, and Asia. We enrolled patients aged 18 years or older with spontaneous, non-traumatic, supratentorial intracerebral haemorrhage of 30 mL or more. We used a computer-generated number sequence with a block size of four or six to centrally randomise patients to image-guided MISTIE treatment (1.0 mg alteplase every 8 h for up to nine doses) or standard medical care. Primary outcome was good functional outcome, defined as the proportion of patients who achieved a modified Rankin Scale (mRS) score of 0-3 at 365 days, adjusted for group differences in prespecified baseline covariates (stability intracerebral haemorrhage size, age, Glasgow Coma Scale, stability intraventricular haemorrhage size, and clot location). Analysis of the primary efficacy outcome was done in the modified intention-to-treat (mITT) population, which included all eligible, randomly assigned patients who were exposed to treatment. All randomly assigned patients were included in the safety analysis. This study is registered with ClinicalTrials.gov, number NCT01827046. FINDINGS Between Dec 30, 2013, and Aug 15, 2017, 506 patients were randomly allocated: 255 (50%) to the MISTIE group and 251 (50%) to standard medical care. 499 patients (n=250 in the MISTIE group; n=249 in the standard medical care group) received treatment and were included in the mITT analysis set. The mITT primary adjusted efficacy analysis estimated that 45% of patients in the MISTIE group and 41% patients in the standard medical care group had achieved an mRS score of 0-3 at 365 days (adjusted risk difference 4% [95% CI -4 to 12]; p=0.33). Sensitivity analyses of 365-day mRS using generalised ordered logistic regression models adjusted for baseline variables showed that the estimated odds ratios comparing MISTIE with standard medical care for mRS scores higher than 5 versus 5 or less, higher than 4 versus 4 or less, higher than 3 versus 3 or less, and higher than 2 versus 2 or less were 0.60 (p=0.03), 0.84 (p=0.42), 0.87 (p=0.49), and 0.82 (p=0.44), respectively. At 7 days, two (1%) of 255 patients in the MISTIE group and ten (4%) of 251 patients in the standard medical care group had died (p=0.02) and at 30 days, 24 (9%) patients in the MISTIE group and 37 (15%) patients in the standard medical care group had died (p=0.07). The number of patients with symptomatic bleeding and brain bacterial infections was similar between the MISTIE and standard medical care groups (six [2%] of 255 patients vs three [1%] of 251 patients; p=0.33 for symptomatic bleeding; two [1%] of 255 patients vs 0 [0%] of 251 patients; p=0.16 for brain bacterial infections). At 30 days, 76 (30%) of 255 patients in the MISTIE group and 84 (33%) of 251 patients in the standard medical care group had one or more serious adverse event, and the difference in number of serious adverse events between the groups was statistically significant (p=0.012). INTERPRETATION For moderate to large intracerebral haemorrhage, MISTIE did not improve the proportion of patients who achieved a good response 365 days after intracerebral haemorrhage. The procedure was safely adopted by our sample of surgeons. FUNDING National Institute of Neurological Disorders and Stroke and Genentech.
Clinical Outcomes Associated With Allogeneic Red Blood Cell Transfusions in Spinal Surgery: A Systematic Review
Global spine journal. 2019;9(4):434-445
Study Design: Systematic review. Objectives: The objectives of this systematic review were to report the available clinical evidence on patient outcomes associated with perioperative allogeneic red blood cell (RBC) transfusions in adult patients undergoing spinal surgery and to determine whether there is any evidence to support an association between transfusion timing and clinical outcomes. Methods: A systematic review of the PubMed, EMBASE, and Cochrane Library databases was performed to identify all articles examining outcomes of adult spinal surgery patients who received perioperative allogeneic RBC transfusions. The level of evidence for each study was assessed using the "Oxford Levels of Evidence 2" classification system. Meta-analysis was not performed due to the heterogeneity of reports. Results: A total of 2759 unique citations were identified and 76 studies underwent full-text review. Thirty-four studies were selected for analysis. All the studies, except one, were retrospective. Eleven studies investigated intraoperative or postoperative transfusions. Only one article compared outcomes related to intraoperative versus postoperative transfusions. Conclusions: Perioperative transfusion is associated with increased rates of postoperative complications, especially infectious complications, and prolonged length of stay. Some evidence suggests that a dose-response relationship may exist between morbid events and the number of RBC units administered, but these findings are inconsistent. Because of the heterogeneity of reports and inconsistent findings, the incidence of specific complications remains unclear. Limited research activity has focused on intraoperative versus postoperative transfusions, or the effect of transfusion on functional outcomes of spine surgery patients. Further research is warranted to address these clinical issues.
Efficacy of thromboelastography to monitor the clinical massive transfusion in scoliosis: a randomized controlled trial
Zhonghua Wai Ke Za Zhi [Chinese Journal of Surgery]. 2016;54((2)):137-41.
OBJECTIVE To systematically assess the benefits and harms of a thromboela-stogram (TEG) guided transfusion strategy with severe bleeding. METHODS In this prospective study, 60 patients scheduled for scoliosis were included in the Fourth Affiliated Hospital, Xinjiang Medical University, from May 2014 to February 2014.Patients were allocated into either an TEG group or a standard management group. RESULTS There was no significant difference in age, weight, height and operation time between the two groups (P>0.05). There were significant differences in red blood cell concentration((4.5+/-1.5)units and(7.1+/-1.2)units)(t=4.343, P=0.001), platelet((2.5+/-1.3)units and (4.2+/-0.6)units)(t=4.554, P=0.002), fresh frozen plasma((234+/-46)ml and(514+/-41)ml)(t=3.723, P=0.004), fibrinogen((2.4+/-0.6)g and (4.6+/-0.7)g)(t=3.451, P=0.006) between the TEG group and the standard management group.The two groups in intraoperative blood loss((1 023+/-103)ml and (1 314+/-116)ml)(t=2.260, P=0.120), incidence of rebleeding after operation(3.1% and 3.6%)(chi(2)=0.340, P=0.450), hospitalization time((18+/-4)d and (16+/-6)d)(t=2.140, P=0.160) had no statistically significant differences. CONCLUSION Application of a TEG guided transfusion strategy seems to reduce the amount of bleeding during correction operation of scoliosis.
A clinical trial to detect subclinical transfusion-induced lung injury during surgery
BACKGROUND Transfusion-related acute lung injury incidence remains the leading cause of posttransfusion mortality. The etiology may be related to leukocyte antibodies or biologically active compounds in transfused plasma, injuring susceptible recipient's lungs. The authors have hypothesized that transfusion could have less severe effects that are not always appreciated clinically and have shown subtly decreased pulmonary oxygen gas transfer in healthy volunteers after transfusion of fresh and 21-day stored erythrocytes. In this study, the authors tested the same hypothesis in surgical patients. METHODS Ninety-one patients undergoing elective major spine surgery with anticipated need for erythrocyte transfusion were randomly allocated to receive their first transfusion of erythrocytes as cell salvage (CS), washed stored, or unwashed stored. Clinicians were not blinded to group assignment. Pulmonary gas transfer and mechanics were measured 5 min before and 30 min after erythrocyte transfusion. RESULTS The primary outcome variable, gas transfer, as assessed by change of PaO2/FIO2, with erythrocyte transfusion was not significant in any group (mean +/- SD; CS: 9 +/- 59; washed: 10 +/- 26; and unwashed: 15 +/- 1) and did not differ among groups (P = 0.92). Pulmonary dead space (VD/VT) decreased with CS transfusion (-0.01 +/- 0.04; P = 0.034) but did not change with other erythrocytes; the change from before to after erythrocyte transfusion did not differ among groups (-0.01 to +0.01; P = 0.28). CONCLUSIONS The authors did not find impaired gas exchange as assessed by PaO2/FIO2 with transfused erythrocytes that did or did not contain nonautologous plasma. This clinical trial did not support the hypothesis of erythrocyte transfusion-induced gas exchange deficit that had been found in healthy volunteers.
Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study
Journal of Clinical Monitoring & Computing. 2015;29((6)):733-40.
Continuous, noninvasive hemoglobin (SpHb) monitoring provides clinicians with the trending of changes in hemoglobin, which has the potential to alter red blood cell transfusion decision making. The objective of this study was to evaluate the impact of SpHb monitoring on blood transfusions in high blood loss surgery. In this prospective cohort study, eligible patients scheduled for neurosurgery were enrolled into either a Control Group or an intervention group (SpHb Group). The Control Group received intraoperative hemoglobin monitoring by intermittent blood sampling when there was an estimated 15 % blood loss. If the laboratory value indicated a hemoglobin level of <10 g/dL, a red blood cell transfusion was started and continued until the estimated blood loss was replaced and a laboratory hemoglobin value was >l0 g/dL. In the SpHb Group patients were monitored with a Radical-7 Pulse CO-Oximeter for continuous noninvasive hemoglobin values. Transfusion was started when the SpHb value fell to l0 g/dL. Blood samples were taken pre and post transfusion. Percent of patients transfused, average amount of blood transfused in those who received transfusions and the delay time from the hemoglobin reading of <10 g/dL to the start of transfusion (transfusion delay) were compared between groups. The trending ability of SpHb, and the bias and precision of SpHb compared to the laboratory hemoglobin were calculated. Compared to the Control Group, the SpHb Group had fewer units of blood transfused (1.0 vs 1.9 units for all patients; p < 0.001, and 2.3 vs 3.9 units in patients receiving transfusions; p < 0.0 l), fewer patients receiving >3 units (32 vs 73 %; p < 0.01) and a shorter time to transfusion after the need was established (9.2 +/- 1.7 vs 50.2 +/- 7.9 min; p < 0.00 l). The absolute accuracy of SpHb was 0.0 +/- 0.8 g/dL and trend accuracy yielded a coefficient of determination of 0.93. Adding SpHb monitoring to standard of care blood management resulted in decreased blood utilization in high blood loss neurosurgery, while facilitating earlier transfusions.
An open-label, randomized, parallel-group study of perioperative epoetin alfa versus standard of care for blood conservation in major elective spinal surgery: safety analysis
STUDY DESIGN Prospective, open-label, randomized, parallel-group study at 80 centers. OBJECTIVE To demonstrate there is no clinically important additional risk for deep vein thrombosis with perioperative use of epoetin alfa versus standard of care in spine surgery without prophylactic anticoagulation. SUMMARY OF BACKGROUND DATA Trials of epoetin alfa in orthopedic surgery that demonstrated no additional risk of thrombovascular events included perioperative pharmacologic anticoagulation. METHODS Subjects received epoetin alfa 600 U/kg subcutaneously once weekly starting 3 weeks before spinal surgery plus standard of care for blood conservation, or standard of care alone. Perioperative anticoagulation therapy was not permitted; mechanical deep vein thrombosis prophylaxis was allowed. Doppler imaging for deep vein thrombosis was done on postoperative day 4 (or day of discharge), or for suspected deep vein thrombosis. Deep vein thrombosis was diagnosed by Doppler result or adverse event report. The criterion for no additional risk of deep vein thrombosis was a 1-sided 97. 5% upper confidence limit < or =4% between groups. RESULTS Of the 680 subjects analyzed (340 in each treatment group), 16 (4. 7%) in the epoetin alfa group and 7 (2. 1%) in the standard of care group had a diagnosis of deep vein thrombosis either by Doppler or by adverse event report with normal Doppler. The between-group difference was 2. 6% (97. 5% upper confidence limit, 5. 4%). Deep vein thrombosis confirmed by Doppler (4. 1% vs. 2. 1%), other clinically relevant thrombovascular events (1. 5% vs. 0. 9%), and all adverse events combined (76. 5% vs. 73. 2%) occurred with similar frequency in the 2 treatment groups. CONCLUSION This study documented a higher incidence of deep vein thrombosis and similar rates of other clinically relevant thrombovascular events with epoetin alfa versus standard of care for blood conservation in subjects who did not receive prophylactic anticoagulation before spinal surgery. Antithrombotic prophylaxis should be considered when erythropoietin is used in the surgical setting.
Minimal effective dosage of recombinant human erythropoietin in spinal surgery
Clinical Orthopaedics and Related Research. 2003;412:71-6.
Preoperative autologous blood donation is one of the most widely used methods of autotransfusion. However securing a predetermined amount of blood (3 units of whole blood) may be difficult in patients with a low preoperative hematocrit. To determine the minimum effective pretreatment dosage of recombinant human erythropoietin required to secure an adequate amount of preoperative blood for autologous transfusion during posterior decompression and instrumentation fusion using the pedicle screw-rod system in the lumbar spine, a prospective randomized clinical trial was done. Forty-five patients who had a preoperative hematocrit less than 40% were selected and were divided blindly into three groups. Fifty units per kilogram of recombinant human erythropoietin seems to be the minimal effective dosage for securing an adequate amount of preoperative autologous blood donation.