Safety and efficacy of drug coated balloon angioplasty for intracranial atherosclerotic disease.

BACKGROUND: Drug coated balloon (DCB) angioplasty can provide sustained anti-restenotic efficacy without the limitations of permanent vascular implantation and is presumably ideal for treating intracranial atherosclerotic disease. However, the safety of paclitaxel in the neurovasculature remains a concern. METHODS: 242 patients with angiographically verified symptomatic stenosis >70% in intracranial arteries treated with DCB angioplasty were reviewed divided into two groups: group A, patients with stenotic intracranial arteries; and group B, patients with acute, subacute, or chronic occluded intracranial arteries. The primary endpoint was any stroke or death within 30 days. The secondary endpoint was arterial restenosis of >50% during follow-up. RESULTS: 16 major and 12 minor complications occurred among 245 procedures (6.5% and 4.9%, respectively). Five patients died within 30 days after the procedure (2.1%, 5/242). 12 major and 12 minor complications occurred among 211 procedures in group A (5.7% and 5.7%). In group B, four major complications occurred among 34 procedures (11.8%). Hyperperfusion and perforator stroke accounted for half of all complications (53.6%, 15/28). Restenosis >50% was present in eight lesions during the follow-up period (4.8%, 8/167). CONCLUSIONS: After treatment with DCB angioplasty, complications were no different from those after standard balloon angioplasty or stenting. This study suggests that DCB angioplasty may be a safe and effective procedure for intracranial arterial stenosis.

Application of drug-coated balloons for intracranial atherosclerosis disease: a systematic review.

BACKGROUND: Although percutaneous transluminal angioplasty and stenting (PTAS) was an effective and safe alternative treatment for severe intracranial atherosclerosis disease (ICAD), the high rate of restenosis remained a major issue for this endovascular procedure. Recently, the application of drug-coated balloons (DCB) in ICAD was developed to reduce restenosis. This systematic review aimed to evaluate the efficacy and safety of DCB angioplasty for ICAD. METHODS: We searched relevant databases for eligible studies enrolling ICAD patients treated with DCB. The event rates of restenosis and periprocedural complications in the follow-up period were pooled with random-/fixed-effect models using Freeman-Tukey double arcsine transformation. Heterogeneity tests and publication bias tests were performed. RESULTS: Two hundred and twenty-four ICAD patients treated with DCB from 9 eligible studies were included. Rate of stenosis in the DCB arm before treatment was ranged from 62% to 90% and reported median follow-up was ranged from 3 to 10.7 months. The pooled incidence of restenosis were 5.7% (95% confidence interval [CI] 2.6%-9.7%; I2 = 0%, p = 0.516) and 5.9% for periprocedural complications (95% CI: 2.5-10.3%; I2 = 0%, p = 0.649) in follow-up term. CONCLUSION: With the limitation of the low quality of the available evidence, angioplasty with DCB appears to be effective and safe in severe ICAD. Further larger randomized trials are needed to provide more definitive evidence and to address the ideal clinical context for their application.

Ticagrelor versus clopidogrel in stent-assisted coil embolization of unruptured intracranial aneurysms.

BACKGROUND: Dual antiplatelet therapy is widely used for stent-assisted coil embolization (SACE) for unruptured intracranial aneurysms (UIAs) to prevent thromboembolic events (TEs). Compared to clopidogrel associated with aspirin, knowledge of the safety and efficacy of ticagrelor is lacking in large studies to date. METHODS: A retrospective cohort study was conducted from January 2016 to December 2018 with at least one year of follow-up in a single institution and systemic review. RESULTS: Altogether, 153 patients with UIA receiving SACE were separated into two groups: 113 patients receiving clopidogrel plus aspirin and 40 patients receiving ticagrelor plus aspirin. Acute in-stent thrombotic events were noted in two patients in the clopidogrel group (1.77%) and none in the ticagrelor group (0%). Additionally, one patient (0.88%) in the clopidogrel group had an early ischemic stroke (<3 months). Delayed ischemic stroke was noted in 6 patients (5.31%) in the clopidogrel group and 3 patients (7.50%) in the ticagrelor group. There were no major hemorrhagic events in either group. The two groups showed no significant differences with regard to ischemic stroke or hemorrhagic stroke. CONCLUSION: Compared to the clopidogrel based regimen, ticagrelor can also reduce TEs without increasing bleeding tendency for SACE of UIAs. Ticagrelor combined with low-dose aspirin is a safe and effective alternative option for SACE.

Leave Nothing Behind: Treatment of Intracranial Atherosclerotic Disease with Drug-Coated Balloon Angioplasty.

PURPOSE: Intracranial atherosclerosis disease (ICAD) is an essential cause of stroke. The characteristics of effective treatment include low periprocedural risk and a sustained treatment effect. Angioplasty with a conventional balloon for ICAD is safe but has a dauntingly high restenosis rate. Drug-coated balloon (DCB) angioplasty might reduce the risk of restenosis while maintaining the overall safety of the procedure. METHODS: This study included symptomatic ICAD patients with more than 70% stenosis. Intermediate catheters were placed distally, and the lesions were predilated with a conventional balloon, followed by a DCB (SeQuent Please, B Braun, Melsungen, Germany). The primary endpoint was any stroke or death within 30 days or ipsilateral ischemic stroke thereafter. The secondary endpoint was arterial restenosis of more than 50% during follow-up. RESULTS: A total of 39 sessions of DCB angioplasty were performed for 39 lesions in 35 patients between October 2015 and April 2018 in a single center. All of the DCBs could be navigated to the lesions. Major periprocedural complications were noted in two patients (5.7%, 2/35), and minor periprocedural complications were also noted in two patients (5.7%, 2/35). The average percentages of stenosis of the lesions were 76.6% ± 7% before treatment, 32.4% ± 11.2% after DCB angioplasty, and 25% ± 16% at follow-up. Stenosis over 50% was present in 3 lesions during the follow-up period (8.3%, 3/36). CONCLUSION: In this study, the application of DCBs to treat ICAD patients was feasible and safe. A larger scale clinical trial is warranted to further evaluate the safety and efficacy of this treatment.

Early strategy of scepter XC balloon angioplasty and simultaneous Nimodipine infusion for vasospasm following ruptured aneurysm.

BACKGROUND: Cerebral vasospasm still results in high morbidity and mortality rates in patients after aneurysmal subarachnoid hemorrhage (SAH). The aim of this study was to establish a protocol for the management of vasospasm and demonstrate our experience of angioplasty using the Scepter XC balloon catheter. METHODS: In this retrospective study, a computed tomography angiography and perfusion image was arranged if early symptoms occurred or on the 7th day following aneurysmal SAH. In patients with clear consciousness, balloon angioplasties were performed for symptomatic vasospasms, which were not improved within 6-12 h after maximal medical treatments. In unconscious patients, balloon angioplasties were performed for all patients with angiographic vasospasms. RESULTS: Fifty patients underwent Scepter XC balloon angioplasty among 396 consecutive patients who accepted endovascular or surgical treatments for ruptured aneurysms. All angioplasty procedures were successful without complications. 100% angiographic improvement and 94% clinical improvement were reached immediately after the angioplasties. A favorable functional outcome (modified Rankin Score of ≤2) could be achieved in 82% of patients. Even in patients with poor clinical grading (Hunt-Hess grade 4-5), a clinical improvement rate of 87.5% and favorable outcome rate was 70.8% could be achieved. CONCLUSION: Balloon angioplasty with Scepter XC balloon catheter is safe and effective for post-SAH vasospasm. This device's extra-compliant characteristics could considerably improve the quality of angioplasty procedures. For all patients, even those with poor neurological status, early treatment with combined protocol of nimodipine and angioplasty can have good clinical outcomes.

Warning headache correlates survival rate in aneurysmal subarachnoid hemorrhage.

BACKGROUND: Severe headaches, projectile vomiting, focal neurological deficits and early onset seizure are regarded as early warning symptoms of subarachnoid hemorrhage (SAH). Earlier diagnosis based on such warning symptoms theoretically would improve the clinical prognosis. However, it is still not clear whether the prognosis is correlated with early warning symptoms. Here, we reviewed warning symptoms and other predictive factors in the emergency room (ER) setting and examined their correlations with mortality. METHODS: Ninety saccular aneurysmal SAH cases were reviewed in a single medical center between January 2011 and December 2013. We examined differences in mortality rate related to warning symptoms, SAH scales, onset-to-ER time, hydrocephalus, and aneurysm size, location, and complexity. Logistic regression analyses were performed to determine the correlations of warning symptoms and other predictive factors with mortality. Receiver operating characteristic (ROC) curve analysis was used to calculate the area the under curve (AUC) of SAH mortality prediction tools. RESULTS: Warning headache, projectile vomiting, the Hunt and Hess scale, Fisher scale, World Federation of Neurological Surgeons (WFNS) grading scale, and modified WFNS (m-WFNS) scale, body mass index, aneurysm complexity and hydrocephalus were significantly different between the survivors and the decedents. The warning headache and WFNS grade were strongly correlated with mortality. The rate of prognostic prediction improved from 90.4% to 94.6% when warning headache was additionally evaluated. CONCLUSIONS: With growing healthcare costs and recognition of the value of palliative care, early identification via warning headache and a detailed clinical history review is necessary for cases of aSAH.

The ANTRACK Technique: Employing a Compliant Balloon or Stent Retriever to Advance a Large-Bore Catheter to an Occlusion During Thrombectomy Procedures in Acute Stroke Patients.

BACKGROUND: Stent retrievers and thrombosuction catheters have become the cornerstones of acute stroke therapy. A large-lumen catheter facilitates the passage of different instruments and the application of greater suction force to clots. However, positioning a flexible thrombosuction or intermediate catheter within a tortuous artery is difficult and time-consuming. OBJECTIVE: To evaluate the efficacy and safety of the ANchor TRACKing (ANTRACK) technique in achieving distal positioning of a large-lumen catheter in a tortuous cranial artery. We summarize our experience using either a compliant balloon catheter or a stent retriever as an anchor in the distal vessels to facilitate the navigation of a large-lumen catheter into the distal circulation. METHODS: Consecutive patients who underwent thrombectomy using the ANTRACK technique were identified. Patient characteristics, procedure details, and outcomes were reviewed from our database. The efficacy and safety of advancing thrombosuction or intermediate catheters to the site of an occlusion were the primary outcome measures. Secondary outcomes included the recanalization result. RESULTS: Thirty-nine patients who underwent thrombectomy using the ANTRACK technique were identified; a compliant balloon was used in 32 patients and a stent-retriever was used in 7 patients. The primary outcomes were achieved in all patients. No adverse event was observed. The secondary outcome of recanalization of an occluded artery was achieved in 34 patients (87.2%). CONCLUSION: The ANTRACK technique using either a compliant balloon catheter or a stent-retriever is an effective and safe way of passing a large-bore catheter through a tortuous carotid siphon, particularly in cases with atheromatous plaque or ulceration.

Effect of Intracranial Pressure Control on Improvement of Cerebral Perfusion After Acute Subarachnoid Hemorrhage: A Comparative Angiography Study Based on Temporal Changes of Intracranial Pressure and Systemic Pressure.

OBJECTIVE: Increased intracranial pressure (ICP) is a well-known complication after aneurysmal subarachnoid hemorrhage (aSAH). This study focused on the different temporal changes in ICP, mean arterial pressure, and cerebral perfusion pressure at the early stage of aSAH, throughout aneurysm embolization, and their effects on improvement in angiographic perfusion patterns. METHODS: Twenty-seven patients with aSAH were evaluated who underwent coiling and cerebrospinal fluid (CSF) drainage. Diagnostic angiography was performed to confirm the presence and location of the vascular lesion. The transit time of the capillary filling phase was defined as a surrogate of cerebral perfusion. Capillary filling transit times were compared before and after CSF drainage. Univariate and multivariate analyses were performed to identify associations between different physical parameters and capillary filling transit times. RESULTS: By univariate analysis, average capillary transit time before CSF drainage had a significant correlation with initial ICP (P = 0.0004; R2 = 0.398) but not systemic pressure (mean arterial pressure or cerebral perfusion pressure). Improvement in capillary filling pattern (i.e., a decrease in angiographic capillary transit time after CSF drainage) was seen in patients with high initial ICP and correlated with ICP difference after ventricular drainage (P = 0.0001 and P < 0.0001, respectively). Using multivariate regression analysis, improved control in postprocedural ICP levels significantly correlated with angiographic evidence of improved cerebral perfusion (P = 0.0243). CONCLUSIONS: Decreasing ICP by CSF drainage strongly correlated with improved cerebral microcirculation after aSAH. Further development of ICP control protocols that can provide better ICP management of patients with aSAH is warranted.

Recombinant Tissue Plasminogen Activator in Acute Ischemic Stroke Patients Receiving Thrombectomy: Standard or Low Dose Therapy?

BACKGROUND: We compared the clinical outcomes of low and standard dose recombinant tissue Plasminogen Activator (rtPA) treatment in Acute Ischemic Stroke (AIS) patients receiving Endovascular Mechanical Thrombectomy (EVT). METHODS: Between April 01, 2015 and September 30, 2017, all AIS patients admitted to the Linkou and Chiayi Chang Gung Memorial Hospital were retrospectively reviewed. Patients with large vessel occlusions, who underwent bridging therapy with rtPA and EVT, were further enrolled. The enrolled patients were categorized into low (0.6-0.7 mg/kg; LD) or standard dose (0.9 mg/kg; SD) group based on the dose of rtPA they received. Baseline characteristics, reperfusion status, and clinical outcomes were compared between the two groups. RESULTS: Forty-two patients were enrolled in the final analyses, including 13 in the LD and 29 in the SD group. In all groups analyzed, the frequencies of moderate to severe and severe stroke at discharge were significantly decreased compared to those at stroke onset (p < 0.01). Compared to the SD group, patients of the LD group had a similar rate of mortality (LD vs. SD; 0% vs. 3.4%, p = 1.00), and comparable frequencies of functional independence at 3 months after stroke onset (LD vs. SD; 33.3% vs. 44.8%, p = 0.50). The rates of symptomatic intracerebral hemorrhage were also similar between the two groups (LD vs. SD; 0% vs. 6.9%, p =1.00). CONCLUSIONS: Compared to standard dose treatment, low dose rtPA may have similar clinical efficacy and safety outcomes in AIS patients receiving bridging therapy.

Long-Term Outcomes for Patients With Stroke After Coronary and Valve Surgery.

BACKGROUND: Postoperative stroke is one of the most devastating complications of cardiac surgery. When life-threatening situations such as large infarction and hemorrhage occur, neurosurgical procedures may be performed. In this study, we analyzed the long-term medical and surgical outcomes of stroke after cardiac surgery. METHODS: We conducted a retrospective, nationwide, population-based study. All enrolled patients underwent first-time cardiac surgery and were further divided into the subgroups of nonstroke, stroke with medical treatment, and stroke with neurosurgical treatment. All-cause mortality, recurrent stroke, and readmission were analyzed. RESULTS: We included 67,051 patients in this study. Patients with postoperative stroke (2.6%, n = 1,731) exhibited an in-hospital mortality rate of 12.3% (n = 213) and a 5-year mortality rate of 49.1% (n = 850). Unprecedentedly, the 83 patients who underwent neurosurgical procedures exhibited an in-hospital mortality of 16.9%; this rate increased to 65.1% at the 5-year follow-up. This neurosurgical subgroup exhibited the highest rate of long-term mortality (p < 0.001). In the neurosurgical subgroup, age was the risk factor for all-cause mortality (hazard ratio, 2.60; 95% confidence interval, 1.60-4.24; p < 0.001). CONCLUSIONS: Postoperative stroke often leads to high mortality and poor long-term outcomes. Patients who experienced a severe stroke and underwent neurosurgical procedures also exhibited poor outcomes. Patients and their families should be informed of relatively high mortality and poor long-term outcomes before neurosurgical operation.

The venous delay phenomenon in computed tomography angiography: a novel imaging outcome predictor for poor cerebral perfusion after severe aneurysmal subarachnoid hemorrhage.

OBJECTIVE: Diverse treatment results are observed in patients with poor-grade aneurysmal subarachnoid hemorrhage (aSAH). Significant initial perfusion compromise is thought to predict a worse treatment outcome, but this has scant support in the literature. In this cohort study, the authors correlate the treatment outcomes with a novel poor-outcome imaging predictor representing impaired cerebral perfusion on initial CT angiography (CTA). METHODS: The authors reviewed the treatment results of 148 patients with poor-grade aSAH treated at a single tertiary referral center between 2007 and 2016. Patients with the "venous delay" phenomenon on initial CTA were identified. The outcome assessments used the modified Rankin Scale (mRS) at the 3rd month after aSAH. Factors that may have had an impact on outcome were retrospectively analyzed. RESULTS: Compared with previously identified outcome predictors, the venous delay phenomenon on initial CTA was found to have the strongest correlation with posttreatment outcomes on both univariable (p < 0.0001) and multivariable analysis (OR 4.480, 95% CI 1.565-12.826; p = 0.0052). Older age and a higher Hunt and Hess grade at presentation were other factors that were associated with poor outcome, defined as an mRS score of 3 to 6. CONCLUSIONS: The venous delay phenomenon on initial CTA can serve as an imaging predictor for worse functional outcome and may aid in decision making when treating patients with poor-grade aSAH.

Raised Proinflammatory Cytokine Production Within Cerebrospinal Fluid Precedes Fever Onset in Patients With Neurosurgery-Associated Bacterial Meningitis.

OBJECTIVE: The objective of the present study was to determine whether selective inflammatory cytokine concentrations within cerebrospinal fluid are useful markers for the differential diagnosis of aseptic and bacterial meningitis within neurosurgical patients. DESIGN: Prospective, open-label, observational, cohort study. SETTING: Neurosurgical ICU, Chang Gung Memorial Hospital. PATIENTS: Thirty-two consecutive neurosurgical patients who had postoperative fever following external ventricular drain insertion for the treatment of brain injury underwent serial cerebrospinal fluid cytokine analysis pre and post fever to determine the value of such markers in ascertaining the differential diagnosis of meningitis. INTERVENTION: Cerebrospinal fluid samples were collected on the day of fever onset, as well as on day 2 and 4 pre and post fever development. Tumor necrosis factor-α, interleukin-1ß, interleukin-6, interleukin-8, transforming growth factor-ß, and procalcitonin were subsequently analyzed using enzyme-linked immunosorbent assay analysis techniques. MEASUREMENT AND MAIN RESULTS: Inflammatory marker levels were compared among febrile aseptic, bacterial, and nonmeningitis patients to determine cerebrospinal fluid inflammatory changes over time. Significant increases in cerebrospinal fluid tumor necrosis factor -α, interleukin-1ß, interleukin-6, and interleukin-8 levels were observed within patients with bacterial meningitis at fever onset, which was not evident in aseptic or nonmeningitis patients. Furthermore, significant increases in cerebrospinal fluid tumor necrosis factor-α, interleukin-1ß, interleukin-6, and interleukin-8 levels were detected as early as 4 days prior to fever onset within patients with bacterial meningitis when compared with both aseptic and nonmeningitis groups. Interestingly, procalcitonin was only significantly increased in patients with bacterial meningitis on the fourth day post fever. CONCLUSION: The present study suggests that raised cerebrospinal fluid tumor necrosis factor -α, interleukin-1ß, and interleukin-8 in a temporal manner may indicate early bacterial meningitis development in neurosurgical patients, enabling earlier diagnostic certainty and improved patient outcomes.

Balloon test occlusion of the internal carotid artery with stump pressure ratio and venous phase delay technique.

Balloon test occlusion (BTO) is crucial before sacrificing parent arteries. We proposed a simple paradigm combining clinical tolerance with venous phase technique and stump pressure ratio as a criterion for sufficient collateral flow. Internal carotid artery (ICA) occlusion was considered safe for asymptomatic patients who exhibited less than 2 seconds of venous phase delay or had a stump pressure ratio greater than 60%. A total of 37 BTO procedures were performed on 31 patients. Twenty-three patients were monitored clinically and 3 were symptomatic. Venous phase comparison was performed on 27 patients, and 5 failed the test. The stump pressure was measured in all patients, and 7 patients failed the test. In summary, 7 patients failed the BTO, of which 6 received high-flow bypass and 1 of these 6 were symptomatic and exhibited stump pressure ratios less than 60% in the second BTO procedure. Occlusion of the ICA was performed on 29 patients. Only 1 patient developed delayed vasospasm and brain infarction. Adequate collateral flow may be indicated by a stump ratio of 60% or greater with or without a high-flow bypass. Combined with clinical assessment and venous phase technique, ICA occlusion may be a safe option that does not result in delayed ischemic complications.