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.
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.
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.
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.
Comparison of visually estimated blood loss with direct hemoglobin measurement in multilevel spine surgery
BACKGROUND Estimates of blood loss in the operating room are typically performed as a visual assessment by providers, despite multiple studies showing this to be inaccurate. Use of a less subjective measurement of blood loss such as direct measurement of the hemoglobin (Hb) mass lost from the surgical field may better quantify surgical bleeding. The objective of this investigation was to compare anesthesiologist estimates of intraoperative blood loss with measured Hb loss. STUDY DESIGN AND METHODS Sixty patients undergoing posterior spine surgery were enrolled in a prospective, randomized trial comparing intraoperative blood loss using unipolar cautery alone or with use of a bipolar tissue sealant device. Hb concentration and fluid volume were measured from all surgical sponges, suction canisters, and the cell salvage device. Using the volume and concentration of Hb from each solution allowed calculation of Hb mass, which was converted into volume of blood lost and compared with estimates of blood loss documented by the anesthesia team. A single-sample t test of no difference was used to compare estimated with measured blood loss. RESULTS Mean estimated blood loss exceeded measured blood loss by 246 mL (860 mL vs. 614 mL, p < 0.0001). CONCLUSION Estimated blood loss exceeded measured blood loss by 40% on average. The likely etiology of this discrepancy relates to the inability to visually determine Hb concentration of sanguineous solutions in suction canisters and surgical sponges. Ramifications of excessive bleeding estimates include unnecessary transfusion and overadministration of intravenous fluids, both of which may have deleterious effects.