Optimization of cerebral oxygenation based on regional cerebral oxygen saturation monitoring during carotid endarterectomy: A Phase III multicenter, double-blind randomized controlled trial.

BACKGROUND: Whether the optimization of cerebral oxygenation based on regional cerebral oxygen saturation (rSO2) monitoring reduces the occurrence of cerebral ischemic lesions is unknown. METHODS: This multicenter, randomized, controlled trial recruited adults admitted for scheduled carotid endarterectomy. Patients were randomized between the standard of care or optimization of cerebral oxygenation based on rSO2 monitoring using near-infrared spectroscopy. In the intervention group, in case of a decrease in rSO2 in the intervention, the following treatments were sequentially recommended: (1) increasing oxygenotherapy, (2) reducing the tidal volume, (3) legs up-raising, (4) performing a fluid challenge and (5) initiating vasopressor support. The primary endpoint was the number of new cerebral ischemic lesions detected using magnetic resonance imaging pre- and postoperatively. Secondary endpoints included new neurological deficits and mortality on day 120 after surgery. RESULTS: Among the 879 patients who were randomized, 665 (75.7%) were men. There was no statistically significant difference between groups for the mean number of new cerebral ischemic lesions per patient up to 3 days after surgery: 0.35 (±1.05) in the standard group vs. 0.58 (±2.83), in the NIRS group; mean difference, 0.23 [95% CI, -0.06 to 0.52]; estimate, 0.22 [95% CI, -0.06 to 0.50]. New neurological deficits up to day 120 after hospital discharge were not different between the groups: 15 (3,39%) in the standard group vs. 42 (5,49%) in the NIRS group; absolute difference, 2,10 [95% CI, -0,62 to 4,82]. There was no significant difference between groups for the median [IQR] hospital length of stay: 4.0 [4.0 to 6.0] in the standard group vs 5.0 [4.0-6.0] in the NIRS group; mean difference, -0.11 [95% CI, -0.65 to 0.44]. The mortality rate on day 120 was not different between the standard group (0.68%) vs. the NIRS group (0.92%); absolute difference = 0.24% [95% CI, -0.94 to 1.41]. CONCLUSIONS: Among patients undergoing carotid endarterectomy, optimization of cerebral oxygenation based on rSO2 did not reduce the occurrence of cerebral ischemic lesions postoperatively compared with controlled hypertensive therapy. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01415648.

Evaluation of the impact of HMS Plus on postoperative blood loss compared with ACT Plus in cardiac surgery.

BACKGROUND: The standardized management of anticoagulation during the cardiopulmonary bypass seems inaccurate because of patients and surgeries variability. This study evaluates if an individualized management of heparin and protamine guided by the HMS Plus system during cardiopulmonary bypass could reduce postoperative blood loss. METHODS: We conducted a prospective, controlled, unblinded, single-center study. One-hundred and eighthy-eight patients operated for cardiac surgery were included. Patients were divided in ACT Plus group (standardized approach) and HMS Plus group (individualized approach). The primary outcome was blood-loss volume during the first 24 postoperative hours. The main secondary outcomes were the need for allogeneic blood transfusions and the final protamine/heparin ratio. RESULTS: There was no difference between the two groups for baseline characteristics. Medium blood-loss volume in the ACT Plus group was 522±260 mL vs. 527±255 mL in the HMS Plus group (P=0.58). The final protamine/heparin ratio in the ACT Plus group was 0.94±0.1 vs. 0.58±0.1 in the HMS Plus group (P<0.0001). The transfusion rate during surgery in the ACT Plus group was 25% vs. 14% in the HMS Plus group (P=0.09). CONCLUSIONS: HMS Plus did not reduce the mean blood-loss volume during the first 24 postoperative hours compared with ACT Plus. Its utility for potential transfusion rate reduction remains to be proven.

Predictive Factors of Silent Brain Infarcts after Asymptomatic Carotid Endarterectomy.

BACKGROUND: The optimization of medical treatment regularly challenges the role of carotid surgery for asymptomatic patients. Current research seeks to determine which of these patients will benefit most from surgery. The goal of this study was to identify in a multicenter study, using magnetic resonance imaging (MRI), the risk factors for postoperative silent cerebral ischemic lesions after carotid surgery for asymptomatic stenosis. METHODS: The multicenter, retrospective study included patients with asymptomatic severe carotid stenosis suitable for surgical treatment and who did not have a history of cerebral ischemia. A diffusion MRI scan was performed the day before and in the 3 days after the procedure. An analysis by an independent neuroradiologist determined the presence of preoperative silent ischemia and the appearance of new lesions postoperatively. The analysis also took into account the plaque type, lesions of supra-aortic trunks, the circle of Willis, the type of surgery, and anesthesia, shunt use, and clamp time. RESULTS: Between April 2011 and November 2015, 141 patients were included. The mean degree of carotid stenosis in the patients who underwent surgery was 78.2% ± 6.5, with 9 (6.4%) cases of contralateral stenosis ≥70% and 6 (4.3%) of which were thrombosis. The circle of Willis was incomplete in 23 (16.3%) patients. Twenty-one (14.9%) plaques were of high embolic risk. The preoperative MRI found 34 (24.1%) patients with embolic ischemic lesions. The majority of procedures were eversions performed under general anesthesia, 7 (5%) required a shunt, and the mean clamp time was 39 ± 16 min. The postoperative MRI revealed that 10 (7%) patients had a new ischemic lesion on the operated side. None of these lesions were symptomatic. On multivariate analysis, the risk factors for appearance of a new ischemic lesion on the operated side were significant severe stenosis of the vertebral artery ipsilateral to the lesion (odds ratio [OR] = 9.2, 95% confidence interval [CI] [2.1-39.8], P = 0.003) and insertion of a shunt (OR = 9.1, 95% CI [1.1-73.1], P = 0.039). The 30-day follow-up showed one death at D4 due to hemorrhagic stroke on the operated side and one contralateral stroke. None of the study patients had a myocardial infarction. CONCLUSIONS: In this multicenter study, the rate of silent ischemic lesions in asymptomatic carotid surgery showed 43.3% of preoperative silent ischemic lesions and 9.2% of new silent lesions after surgery. The use of a shunt and presence of ipsilateral vertebral stenosis are risk factors for perioperative embolism.

Evaluation by Magnetic Resonance Imaging of Silent Brain Infarcts in Preoperative and Postoperative Asymptomatic Carotid Surgery.

BACKGROUND: To report the prevalence of silent brain infarcts (SBI) at magnetic resonance imaging (MRI) before and after surgery for asymptomatic high grade carotid stenosis. METHODS: This is a single center retrospective observational study. Asymptomatic patients who underwent carotid endarterectomy between October 2012 and October 2014 were included. The preoperative assessment included a Doppler and a computed tomographic (CT) scan dating less than 3 months. A neurological examination was performed during the anesthesia consultation and in the 15 days before surgery. An MRI angiography was performed the day before and 3 days after surgery and was analyzed by an independent neuroradiologist. Preoperative analysis focused on the presence of ischemic events at MRI. The type of plaque, the supra aortic trunk lesions, and the quality of the circle of Willis were analyzed using Doppler and CT scanning. Postoperatively, we searched for signs of postoperative ischemic events at MRI. RESULTS: Forty-one patients were included (85.4% of men), and the mean age was 72.4 ± 8.3 years. We noted 7 (17.1%) contralateral stenoses (>50%) and 2 (4.9%) contralateral thromboses, 6 (14.6%) vertebral stenoses, and 7 (17.1%) abnormalities of the circle of Willis. The morphological analysis described 6 unstable plaques including 4 ulcerated, 1 pseudodissection, and 1 intraplaque hemorrhage. Preoperatively, we noted the presence of 21 (51.2%) ischemic lesions including 9 (21.9%) multiple lacunar ischemic events and 12 (29.3%) silent arterial territory infarcts. Eversion was performed for all patients except for 6 (14.6%), for whom a bypass was necessary. No deaths or major complications were observed in the 30 postoperative days. Postoperatively, MRI showed 3 (7.3%) asymptomatic recent ischemic strokes, 1 ipsilateral middle cerebral artery (MCA) stroke, and 2 contralateral (cerebellar and MCA) strokes. CONCLUSIONS: Patients with asymptomatic significant carotid stenosis show many preoperative SBI indicating a significant embolic risk. It is difficult to conclude about intraoperative embolic risk, but we hope that more data could demonstrate the importance of MRI for the preoperative evaluation of carotid plaques and brain parenchyma, to identify high-risk embolic patients.