Intraoperative intensive blood pressure management strategy and the outcome of patients who had an acute ischaemic stroke undergoing endovascular treatment under general anaesthesia: study protocol for a prospective randomised controlled trial.

BackgroundEndovascular thrombectomy is the recommended treatment for acute ischaemic stroke, but the optimal blood pressure management strategy during the procedure under general anaesthesia remains controversial. In this study protocol, we propose an intraoperative intensive blood pressure range (110-140 mm Hg systolic blood pressure) based on a retrospective analysis and extensive literature review. By comparing the outcomes of patients who had an acute ischaemic stroke undergoing mechanical thrombectomy under general anaesthesia with standard blood pressure management (140-180 mm Hg systolic blood pressure) versus intensive blood pressure management, we aim to determine the impact of intraoperative intensive blood pressure management strategy on patient prognosis. METHODS AND ANALYSIS: The study is a double-blinded, randomised, controlled study, with patients randomised into either the standard blood pressure management group or the intensive blood pressure management group. The primary endpoint of the study will be the sequential analysis of modified Rankin Scale scores at 90 days after mechanical thrombectomy. ETHICS AND DISSEMINATION: The study has been approved by the ethics committee of Shanghai Changhai Hospital with an approval number CHEC2023-015. The results of the study will be published in peer-reviewed international journals. TRIAL REGISTRATION NUMBER: ChiCTR2300070764.

Endovascular treatment of wide-neck bifurcation aneurysms using pCONUS2 HPC bridging device with single antiplatelet: A Case Series.

RATIONALE: Wide neck bifurcation aneurysms (WNBA) are technically challenging for both surgical and endovascular treatments. Endovascular treatment for WNBA often requires dual antiplatelet therapy (DAPT) post stent insertion. Novel devices such as the pCONUS2 HPC neck bridging device have an HPC coating which reduces the device thrombogenicity. This theoretically allows for use of single antiplatelet therapy (SAPT), which would be advantageous, particularly in treating ruptured aneurysms. This case series aims to evaluate the safety of SAPT regimen only post stent insertion, by presenting our center early clinical experience in using pCONUS2 HPC neck bridging device in patients that are not suitable for DAPT. PATIENT CONCERNS: We report the cases of 3 patients (2 females, 1 male; range: 64-71 years old) who underwent coil embolization for WNBA using the pCONUS2 HPC device (2 unruptured WNBA, and 1 ruptured WNBA). As all 3 patients were allergic to Aspirin, they could only be started on SAPT post endovascular therapy. DIAGNOSIS: All 3 patients were diagnosed with WNBA on angiographic studies. Patient 1 had an unruptured left middle cerebral artery aneurysm; Patient 2 had a ruptured basilar tip aneurysm; Patient 3 had an unruptured anterior communicating artery (ACOM) aneurysm. INTERVENTIONS: All 3 WNBA were treated with pCONUS2 HPC neck bridging device. OUTCOMES: There were no immediate complications. The immediate angiographic result of aneurysm treatment in Patient 1 and Patient 2 demonstrated incomplete occlusions, with delayed complete occlusion of aneurysm in Patient 1 and growth of aneurysmal neck in Patient 2 on follow-up angiograms (range: 6-9 months). No major thrombo-embolic or hemorrhagic complications in the first 2 patients. For Patient 3, the immediate angiographic result of the treated aneurysm demonstrated complete occlusion. However, the patient readmitted 11 days post procedure with cerebral infarction, scoring 5 on the modified Rankin scale on discharge. LESSONS: pCONUS2 HPC as a neck bridging device in treating WNBA has yet to be shown superior to traditional techniques and devices. The theoretical advantage of HPC coating reducing its thrombogenicity requiring only SAPT is yet to be proven safe in clinical practice.

Endovascular repair of an abdominal aortic aneurysm with external iliac artery occlusion using VBX as the contralateral leg via axillary delivery: A case report.

RATIONALE: A hostile iliac access route is an important consideration when enforcing endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms (AAA). Herein, we report a case of AAA with unilateral external iliac artery occlusion, for which bifurcated EVAR was successfully performed using a single femoral and brachial artery access. PATIENT CONCERNS: A 76-year-old man who had undergone surgery for lung cancer 4.5 years prior was diagnosed AAA by computed tomography (CT). DIAGNOSIS: Two and a half years before presentation, CT revealed an infrarenal 48 mm AAA, which had enlarged to 57 mm by 2 months preoperatively. CT identified occlusion from the right external iliac artery to the right common femoral artery, with no observed ischemic symptoms in his right leg. The right external iliac artery, occluded and atrophied, had a 1 to 2 mm diameter. INTERVENTION: Surgery was commenced with the selection of a Zenith endovascular graft (Cook Medical) with an extended body length. Two Gore Viabahn VBX balloon expandable endoprosthesis (VBX; W.L. Gore & Associate) were delivered from the right axilla as the contralateral leg. OUTCOMES: CT scan on the 2nd day after surgery revealed no endoleaks. LESSONS: While the long-term results remain uncertain, this method may serve as an option for EVAR in patients with unilateral external iliac artery occlusion.

Bridging the gap: robotic applications in cerebral aneurysms neurointerventions - a systematic review.

Cerebral aneurysm is a life-threatening condition, which requires high precision during the neurosurgical procedures. Increasing progress of evaluating modern devices in medicine have led to common usage of robotic systems in many fields, including cranial aneurysm operations. However, currently no systematic review describes up-to date knowledge of this topic. Following PRISMA guidelines, we have independently screened and extracted works from seven databases. Only studies fulfilling inclusion criteria were presented in this study. Device used, operation time, complications, aneurysm type and patient demographics were extracted from each work. We identified a total of 995 articles from databases. We have found six original works and one supplementary article eligible for this synthesis. Majority of works (4/6) have implemented CorPath GRX in cerebral aneurysm procedures. The procedures involved diverse aneurysm locations, utilizing flow diverters, stents, or coiling. One study described implementation of robot-assist on 117 patients and compared results to randomized clinical trials. One work with a small patient cohort described use of the magnetically-controlled microguidewire in the coiling procedures, without any complications. Additionally, one case-series study described use of a robotic arm for managing intraoperative aneurysm rupture. Currently, robotical devices for cerebral aneurysm treatment mainly lack jailing and haptic feedback feature. Further development of these devices will certainly be beneficial for operators and patients, allowing for more precise and remote surgeries.

Surgeon-modified fenestrated endovascular grafts and thoracoscope-assisted fixation for treatment of thoraco-abdominal aortic aneurysms.

BACKGROUND: Total endovascular technique with fenestrated endovascular graft might be hampered for the late dilatation of proximal landing zone, which may cause endografts migration. We describe a successful urgent hybrid procedure for extent III thoracoabdominal aortic aneurysm with aortic intramural hematoma. CASE PRESENTATION: A 55-year-old female with thoracoabdominal aortic aneurysm was considered at high surgical risk and unfit for open repair due to multiple comorbidities. Therefore, a hybrid procedure of surgeon-modified fenestrated endovascular graft combined with thoracoscope-assisted Transaortic epicardial fixation of endograft was finally chosen and performed in the endovascular operating room. A 3-port technique was performed through a left video-assisted thoracoscopic approach. After the first tampering stent-graft was deployed, a double-needle suture was penetrated both the aortic wall and stent-graft to fixate it in the proximal descending aorta. Then the second endograft, which had been fenestrated on table, was introduced and oriented extracorporeally by rotating superior mesenteric artery and left renal artery fenestration radiopaque markers and deployed with perfect apposition between the fenestrations and target visceral artery. Each vessel was sequentially stented using Viabahn self-expandable stent to finish target vessel stenting. An Ankura cuff stent was deployed in the distal abdominal aortic artery. CONCLUSION: Surgeon-modified fenestrated endovascular graft combined with thoracoscope-assisted fixation may be an innovative and viable alternative for selected high-risk patients with extent III thoracoabdominal aortic aneurysm. A longer follow-up is needed to ascertain the success of this approach.

Nomogram for predicting in-hospital mortality in trauma patients undergoing resuscitative endovascular balloon occlusion of the aorta: a retrospective multicenter study.

Recently, resuscitative endovascular balloon occlusion of the aorta (REBOA) had been introduced as an innovative procedure for severe hemorrhage in the abdomen or pelvis. We aimed to investigate risk factors associated with mortality after REBOA and construct a model for predicting mortality. This multicenter retrospective study collected data from 251 patients admitted at five regional trauma centers across South Korea from 2015 to 2022. The indications for REBOA included patients experiencing hypovolemic shock due to hemorrhage in the abdomen, pelvis, or lower extremities, and those who were non-responders (systolic blood pressure (SBP) < 90 mmHg) to initial fluid treatment. The primary and secondary outcomes were mortality due to exsanguination and overall mortality, respectively. After feature selection using the least absolute shrinkage and selection operator (LASSO) logistic regression model to minimize overfitting, a multivariate logistic regression (MLR) model and nomogram were constructed. In the MLR model using risk factors selected in the LASSO, five risk factors, including initial heart rate (adjusted odds ratio [aOR], 0.99; 95% confidence interval [CI], 0.98-1.00; p = 0.030), initial Glasgow coma scale (aOR, 0.86; 95% CI 0.80-0.93; p < 0.001), RBC transfusion within 4 h (unit, aOR, 1.12; 95% CI 1.07-1.17; p < 0.001), balloon occlusion type (reference: partial occlusion; total occlusion, aOR, 2.53; 95% CI 1.27-5.02; p = 0.008; partial + total occlusion, aOR, 2.04; 95% CI 0.71-5.86; p = 0.187), and post-REBOA systolic blood pressure (SBP) (aOR, 0.98; 95% CI 0.97-0.99; p < 0.001) were significantly associated with mortality due to exsanguination. The prediction model showed an area under curve, sensitivity, and specificity of 0.855, 73.2%, and 83.6%, respectively. Decision curve analysis showed that the predictive model had increased net benefits across a wide range of threshold probabilities. This study developed a novel intuitive nomogram for predicting mortality in patients undergoing REBOA. Our proposed model exhibited excellent performance and revealed that total occlusion was associated with poor outcomes, with post-REBOA SBP potentially being an effective surrogate measure.

Endovascular thrombectomy for treatment of isolated posterior cerebral artery occlusion: a real-world analysis of hospitalizations in the United States.

BACKGROUND: Despite renewed interest and recently demonstrated efficacy for endovascular thrombectomy (EVT) for treatment of acute ischemic stroke (AIS) of the posterior circulation, to date, no randomized clinical trials have been conducted to evaluate EVT for isolated occlusions of the posterior cerebral artery (IPCA). METHODS: Hospitalizations for adult patients with primary admission diagnoses of IPCA occlusion were identified in the National Inpatient Sample registry during the period of 2016-2020. The study exposure was treatment with EVT, and primary clinical endpoints included favorable functional outcome (defined as discharge disposition to home without services, previously shown to have high concordance with modified Rankin scale scores 0-2), in-hospital mortality, and any intracranial hemorrhage (ICH). Inverse probability of treatment weighting (IPTW) was performed to balance baseline clinical characteristics between those receiving EVT or medical management (MM). RESULTS: This analysis identified 34,880 IPCA occlusion hospitalizations, 730 (2.1%) of which documented treatment with EVT. Following IPTW adjustment, EVT was associated with favorable outcome in IPCA patients presenting with mild deficits (M-D) (NIHSS < 6) [adjusted odds ratio (aOR) 2.36, 95% confidence interval (CI) 2.27, 2.45; p < 0.001] and in those presenting with moderate-to-severe deficits (M-S-D) (NIHSS 6-42) (aOR 2.00, 95% CI 1.86, 2.15; p < 0.001). Mortality rates did not differ among those with M-S-D [EVT 4.8% vs. MM 4.7%, p = 0.742], while ICH rates were lower. CONCLUSION: Retrospective analysis of a large administrative registry in the Unites States demonstrates an association of EVT with favorable outcomes following IPCA occlusion, without concomitant risk of hemorrhagic transformation or mortality.

Short-Term Effect of Ambient Temperature in Acute Ischemic Stroke with Endovascular Treatment Due to Large Vessel Occlusion.

Purpose: Acute ischemic stroke (AIS) stands as the primary cause of mortality and extended disability globally. While prior studies have examined the connection between stroke and local weather, they have produced conflicting results. Our goal was to examine the correlation between temperature and functional prognosis in patients with large vessel occlusion (LVO) undergoing endovascular therapy (EVT). Patients and methods: This study included a total of 1809 patients. Temperatures from stroke onset to groin puncture were categorized into Cold (10th percentile of temperature), Cool (10th-50th percentile of temperature), Warm (50th-90th percentile of temperature), and Hot (90th percentile of temperature) groups. The primary efficacy result was the modified Rankin Scale (mRS) score at 90 days. Safety outcomes included mortality, symptomatic intracranial hemorrhage (sICH) and complications after cerebral infarction. Results: The primary efficacy results demonstrated a statistical enhancement in functional outcomes at 90 days for patients in the Warm group compared to the Cold group (adjusted common odds ratio [OR]: 1.386; 95% confidence interval [CI]: 1.024-1.878, P=0.035). Secondary efficacy results showed that temperature was associated with a higher rate of 90-day functional independence (adjusted OR: 1.016; 95% CI: 1.004-1.029; P=0.009), which was higher in the Warm group compared with patients in the Cold group (adjusted OR: 1.646; 95% CI: 1.107-2.448, P=0.014). There were no significant differences between groups in terms of sICH, 90-day mortality, and post-infarction complications. Conclusion: Compared with Cold temperature, Warm temperature is associated with better functional outcomes and reduced mortality risk without increasing the risk of sICH.

Percutaneous ultrasound-guided versus open cut-down access to femoral vessels for the placement of a REBOA catheter.

Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) may be useful in treating exsanguinating trauma patients. This study seeks to compare rates of success, complications and time required for vascular access between ultrasound-guidance and surgical cut-down for femoral sheath insertion as a prospective observational case control study. Participating clinicians from either trauma surgery or anesthesiology were allocated to surgical cut-down or percutaneous ultrasound-guided puncture on a 1:1 ratio. Time spans to vessel identification, successful puncture, and balloon inflation were recorded. 80 study participants were recruited and allocated to 40 open cut-down approaches and 40 percutaneous ultrasound-guided approaches. REBOA catheter placement was successful in 18/40 cases (45%) using a percutaneous ultrasound guided technique and 33/40 times (83%) using the open cut-down approach (p < 0.001). Median times [in seconds] compared between percutaneous ultrasound-guided puncture and surgical cut-down were 36 (18-73) versus 117(56-213) for vessel visualization (p < 0.001), 136 (97-175) versus 183 (156-219) for vessel puncture (p < 0.001), and 375 (240-600) versus 288 (244-379) for balloon inflation (p = 0.08) overall. Access to femoral vessels for REBOA catheter placement is safer when performed by cut-down and direct visualization but can be performed faster by an ultrasound-guided technique when vessels can be identified clearly and rapidly.

Long term outcome after endovascular treatment for large ischemic core acute stroke is associated with hypoperfusion intensity ratio and onset-to-reperfusion time.

BACKGROUND: Endovascular treatment (EVT) is effective for large vessel occlusion (LVO) stroke with smaller volumes of CT perfusion (CTP)-defined core. However, the influence of perfusion imaging during thrombectomy on the functional outcomes of patients with large ischemic core (LIC) stroke at both early and late time windows is uncertain in real-world practice. METHOD: A retrospective analysis was performed on 99 patients who underwent computed tomography angiography (CTA) and CT perfusion (CTP)-Rapid Processing of Perfusion and Diffusion (RAPID) before EVT and had a baseline ischemic core ≥ 50 mL and/or Alberta Stroke Program Early CT Score (ASPECTS) score of 0-5. The primary outcome was the three-month modified Rankin Scale (mRS) score. Data were analyzed by binary logistic regression and receiver operating characteristic (ROC) curves. RESULTS: A fair outcome (mRS, 0-3) was found in 34 of the 99 patients while 65 had a poor prognosis (mRS, 4-6). The multivariate logistic regression analysis showed that onset-to-reperfusion (OTR) time (odds ratio [OR], 1.004; 95% confidence interval [CI], 1.001-1.007; p = 0.008), ischemic core (OR, 1.066; 95% CI, 1.024-1.111; p = 0.008), and the hypoperfusion intensity ratio (HIR) (OR, 70.898; 95% CI, 1.130-4450.152; p = 0.044) were independent predictors of outcome. The combined results of ischemic core, HIR, and OTR time showed good performance with an area under the ROC curve (AUC) of 0.937, significantly higher than the individual variables (p < 0.05) using DeLong's test. CONCLUSIONS: Higher HIR and longer OTR time in large core stroke patients were independently associated with unfavorable three-month outcomes after EVT.

Trends in incidence and treatments of spontaneous subarachnoid hemorrhage- a 10 year hospital based study.

BACKGROUND: Improved endovascular methods make it possible to treat complex ruptured aneurysms, but surgery is still needed in certain cases. We evaluated the effects on the clinical results of the changes in aneurysm treatment. METHODS: The study cohort was 837 patients with spontaneous subarachnoid hemorrhage (SAH) and one or multiple aneurysms, admitted to Dept of Neurosurgery, Uppsala University Hospital from 2012 to 2021. Demography, location and treatment of aneurysms, neurologic condition at admission and discharge, mortality and last tier treatment of high intracranial pressure (ICP) was evaluated. Functional outcome was measured using the Extended Glasgow Outcome Scale (GOSE) Data concerning national incidences of stroke diseases was collected from open Swedish databases. RESULTS: Endovascular methods were used in 666 cases (79.6%). In 111 (13.3%) with stents. Surgery was performed in 115 cases (13.7%) and 56 patients (6.7%) had no aneurysm treatment. The indications for surgery were a hematoma (51 cases, 44.3%), endovascular treatment not considered safe (47 cases, 40.9%), or had been attempted without success (13 cases, 11.3%). Treatment with stent devices increased, and with surgery decreased over time. There was a trend in decrease in hemicraniectomias over time. Both the patient group admitted awake (n = 681) and unconscious (n = 156) improved significantly in consciousness between admission and discharge. Favorable outcome (GOSE 5-8) was seen in 69% for patients admitted in Hunt & Hess I-II and 25% for Hunt & Hess III-V. Mortality at one year was 10.9% and 42.7% for those admitted awake and unconscious, respectively.The number of cases decreased during the study period, which was in line with Swedish national data. CONCLUSIONS: The incidence of patients with SAH gradually decreased in our material, in line with national data. The treatment policy in our unit has been shifting to more use of endovascular methods. During the study period the use of hemicraniectomies decreased.

Future Directions and Innovations in Venous Sinus Stenting.

This review explores the future role of venous sinus stenting (VSS) in the management of idiopathic intracranial hypertension and pulsatile tinnitus. Despite its favorable safety profile and clinical outcomes compared with traditional treatments, VSS is not yet the standard of care for these conditions, lacking high-level evidence data and guidelines for patient selection and indications. Current and recently completed clinical trials are expected to provide data to support the adoption of VSS as a primary treatment option. Additionally, VSS shows potential in treating other conditions, such as dural arteriovenous fistula and cerebral venous sinus thrombosis, and it is likely that the procedure will continue to see an expansion of its approved indications. The current lack of dedicated venous stenting technology is being addressed with promising advancements, which may improve procedural ease and patient outcomes. VSS also offers potential for expansion into modulation of brain electrophysiology via endovascular routes, offering exciting possibilities for neurodiagnostics and treatment of neurodegenerative disorders.

Hybrid noncovered open stents in repair of DeBakey type 1 acute aortic dissections.

OBJECTIVES: The indications for use, evidence base and experience with the novel noncovered open hybrid surgical stents for acute type A aortic dissection repair for concurrent stabilization of the 'downstream' aorta remains limited. We review the evidence base and the development of these stents. METHODS: Data were collected from Pubmed/Medline literature search to develop and review the evidence base for safety and efficacy of non-covered surgical stents. Existing guidelines for use and developments were reviewed. RESULTS: A single randomized control trial and 4 single-centre studies were included in the review with a total worldwide experience of 241 patients. The deployment was easy and did not add significantly to the primary operation. The mortality and new stroke ranged from 6.3-18.7%. Safe and complete deployment was accomplished in 92-100%. There was no device-related reintervention. There was a significant improvement in malperfusion in over 90% of the cases with varying degrees of remodelling (60-90%) of the downstream aorta. CONCLUSIONS: Open noncovered stent grafts represent a major technical advancement as an adjunct procedure for acute dissection repairs, e.g. hemiarch repair. It has potential for wider use by non-aortic surgeons due to simplicity of technique. Limited safety and efficacy data confirm the device to be safe, feasible and reproducible with potential for wider adoption. However, long-term trial and registry data are required before recommendations for standard use outside of high-volume experienced aortic centres.

The ARIA trial protocol: a randomised controlled trial to assess the clinical, technical, and cost-effectiveness of a cloud-based, ARtificially Intelligent image fusion system in comparison to standard treatment to guide endovascular Aortic aneurysm repair.

BACKGROUND: Endovascular repair of aortic aneurysmal disease is established due to perceived advantages in patient survival, reduced postoperative complications, and shorter hospital lengths of stay. High spatial and contrast resolution 3D CT angiography images are used to plan the procedures and inform device selection and manufacture, but in standard care, the surgery is performed using image-guidance from 2D X-ray fluoroscopy with injection of nephrotoxic contrast material to visualise the blood vessels. This study aims to assess the benefit to patients, practitioners, and the health service of a novel image fusion medical device (Cydar EV), which allows this high-resolution 3D information to be available to operators at the time of surgery. METHODS: The trial is a multi-centre, open label, two-armed randomised controlled clinical trial of 340 patient, randomised 1:1 to either standard treatment in endovascular aneurysm repair or treatment using Cydar EV, a CE-marked medical device comprising of cloud computing, augmented intelligence, and computer vision. The primary outcome is procedural time, with secondary outcomes of procedural efficiency, technical effectiveness, patient outcomes, and cost-effectiveness. Patients with a clinical diagnosis of AAA or TAAA suitable for endovascular repair and able to provide written informed consent will be invited to participate. DISCUSSION: This trial is the first randomised controlled trial evaluating advanced image fusion technology in endovascular aortic surgery and is well placed to evaluate the effect of this technology on patient outcomes and cost to the NHS. TRIAL REGISTRATION: ISRCTN13832085. Dec. 3, 2021.

What Is a Meaningful Difference When Using Infarct Volume as the Primary Outcome?: Results From the HERMES Database.

BACKGROUND: Ischemic stroke lesion volume at follow-up is an important surrogate outcome for acute stroke trials. We aimed to assess which differences in 48-hour lesion volume translate into meaningful clinical differences. METHODS: We used pooled data from 7 trials investigating the efficacy of endovascular treatment for anterior circulation large vessel occlusion in acute ischemic stroke. We assessed 48-hour lesion volume follow-up computed tomography or magnetic resonance imaging. The primary outcome was a good functional outcome, defined as modified Rankin Scale (mRS) scores of 0 to 2. We performed multivariable logistic regression to predict the probability of achieving mRS scores of 0 to 2 and determined the differences in 48-hour lesion volume that correspond to a change of 1%, 5%, and 10% in the adjusted probability of achieving mRS scores of 0 to 2. RESULTS: In total, 1665/1766 (94.2%) patients (median age, 68 [interquartile range, 57-76] years, 781 [46.9%] female) had information on follow-up ischemic lesion volume. Computed tomography was used for follow-up imaging in 83% of patients. The median 48-hour lesion volume was 41 (interquartile range, 14-120) mL. We observed a linear relationship between 48-hour lesion volume and mRS scores of 0 to 2 for adjusted probabilities between 65% and 20%/volumes <80 mL, although the curve sloped off for lower mRS scores of 0-2 probabilities/higher volumes. The median differences in 48-hour lesion volume associated with a 1%, 5%, and 10% increase in the probability of mRS scores of 0 to 2 for volumes <80 mL were 2 (interquartile range, 2-3), 10 (9-11), and 20 (18-23) mL, respectively. We found comparable associations when assessing computed tomography and magnetic resonance imaging separately. CONCLUSIONS: A difference of 2, 10, and 20 mL in 48-hour lesion volume, respectively, is associated with a 1%, 5%, and 10% absolute increase in the probability of achieving good functional outcome. These results can inform the design of future stroke trials that use 48-hour lesion volume as the primary outcome.