Enlighten-Research publications by members of the University of Glasgow http://eprints.gla.ac.uk Minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label phase 3 trial with blinded endpoint
BackgroundPreliminary clinical studies on the safety and efficacy of the pipeline embolization device (PED) for the treatment of small/medium aneurysms have demonstrated high occlusion rates with low complications.ObjectiveTo evaluate the safety and effectiveness of the PED for treatment of wide necked small and medium intracranial aneurysms.MethodsPREMIER is a prospective, multicenter, single arm trial. Patients were treated with the PED for unruptured wide necked aneurysms, measuring ≤12 mm along the internal carotid artery or vertebral artery, between July 2014 and November 2015. At 1 year post-procedure, the primary effectiveness endpoint was complete occlusion (Raymond grade 1) without major parent vessel stenosis (≤50%) or retreatment, and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurologic death.ResultsA total of 141 patients were treated with PEDs (mean age 54.6±11.3 years, 87.9% (124/141) women). Mean aneurysm size was 5.0±1.92 mm, and 84.4% (119/141) measured <7 mm. PED placement was successful in 99.3% (140/141) of patients. Mean number of PEDs implanted per patient was 1.1±0.26; a single PED was used in 92.9% (131/141) of patients. At 1 year, 97.9% (138/141) of patients underwent follow-up angiography with 76.8% (106/138) of patients having met the study’s primary effectiveness endpoint. The combined major morbidity and mortality rate was 2.1% (3/140).ConclusionsTreatment of wide necked small/medium aneurysms with the PED results in high rates of complete occlusion without significant parent vessel stenosis and low rates of permanent neurologic complications.Trial registrationNCT02186561.
Chronic subdural haematoma (cSDH) is one of the most frequent neurosurgical entities. Current treatment options include burr hole craniostomy, twist drill craniostomy or craniotomy. While burr hole craniostomy is the most often used technique, there are no studies analysing the use of one vs. two burr holes in respect to recurrence rates and complications. This retrospective study included 76 (age: 60 +/- 12 years) patients presenting with cSDH admitted in our institution from January 2004 to December 2005. A total of 21 (27%) patients underwent bilateral craniostomy. The patients were assessed using the Markwalder Scale (2 +/- 0.71), Glasgow Coma Scale (14 +/- 1) and measuring the haematoma thickness (1.8 +/- 0.7 cm). The decision to perform one or two burr hole was made according to the personal preference of the treating neurosurgeon. All patients underwent irrigation and placement of closed-system drainage. Out of the 97 haematoma, 63 (65%) haematomas were treated with two burr holes, whereas 34 (35%) were treated with one burr hole. Patients with one burr hole had a statistically significant (p < 0.05) higher recurrence rate (29 vs. 5%), longer average hospitalization length (11 vs. 9 days) and higher wound infection rate (9% vs. 0%). A multivariate regression analysis identified the number of holes as single predictor for postoperative recurrence rate (r(2) = 0.12; p < 0.001). In this study, the treatment of cSDH with one burr hole only is associated with a significantly higher postoperative recurrence rate, longer hospitalization length and higher wound infection rate.
Addi"ional informa"ion is available a" "he end of "he chap"er h""p://dx.doi.org/10.5772/57336 . IntroductionChronic subdural hematoma cSDH is one of the most frequent neurosurgical entities caused by head trauma. Since cSDH affects mainly elderly patients and the population continues to age, it has become a common neurosurgical disease seen by both general and specialized health-care practitioners. Despite the increasing prevalence of cSDH, class I studies, and evidence regarding the management of this disease is lacking. We provide an overview of the epidemiology, pathophysiology and etiology of cSDH and discuss several controversial aspects of its management including indication and timing of surgery, steroid treatment, the effectiveness of anti-epileptic prophylaxis, comparative effectiveness of various techniques for surgical evacuation, the timing of postoperative resumption of anticoagulant medication, and protocols for mobilization following evacuation of cSDH. Complications of surgical evacuation such as recurrent hematoma, postoperative epilepsy, brain injury and/or iatrogenic intracerebral bleeding due to hematoma evacuation, drainage insertion or irrigation, and ways to avoid them are also discussed. "s the incidence of cSDH is expected to increase and most treatment aspects lack clear consensus, further large prospective studies are needed. For this reason, a randomized, prospective study evaluating one aspect of the management of cSDH is currently in progress at our institution.. Definition " chronic subdural hematoma cSDH is defined as chronic ≥ weeks intracranial bleeding between the dura mater which adheres to the skull , and the arachnoid mater which envelops © 2014 Soleman e" al.; licensee InTech. This is a paper dis"rib""ed "nder "he "erms of "he Crea"ive Commons A""rib""ion License (h""p://crea"ivecommons.org/licenses/by/3.0), which permi"s "nres"ric"ed "se, dis"rib""ion, and reprod"c"ion in any medi"m, provided "he original work is properly ci"ed. the brain . The underlying cause of cSDH is usually traumatic tearing of the bridging veins which connect the brain surface with the dura mater.[ ]. . EpidemiologyThe incidence of cSDH is estimated at . -per ' people, rising up to per ' people in patients above the age of [ -]. The average age of patients with cSDH is approximately years old [ ]. "s the population continues to mature, incidence is expected to double by the year [ , ]. " large demographic study found the prevalence of cSDH in patients older than to be significantly higher % vs. % [ ]. In addition, men are more frequently affected than women % vs. % . In % of the cases, the patient has suffered a fall in the past and % of the patients were either treated with oral anticoagulants or platelet aggregation inhibitors. The reported recurrence rates range from . % to % [ -]. The most common risk factors are advanced age, alcohol abuse, seizures, cerebrospinal fluid CSF shunts, coagulopathies, blood thinners, and patients at risk for falling e.g. hemiplegia . In -% of the cases, cSDHs are b...
OBJECTIVEThe incidence of already common chronic subdural hematomas (CSDHs) and other nonacute subdural hematomas (NASHs) in the elderly is expected to rise as the population ages over the coming decades. Surgical management is associated with recurrence and exposes elderly patients to perioperative and operative risks. Middle meningeal artery (MMA) embolization offers the potential for a minimally invasive, less morbid treatment in this age group. The clinical and radiographic outcomes after MMA embolization treatment for NASHs have not been adequately described in elderly patients. In this paper, the authors describe the clinical and radiographic outcomes after 151 cases of MMA embolization for NASHs among 121 elderly patients.METHODSIn a retrospective review of a prospectively maintained database across 15 US academic centers, the authors identified patients aged ≥ 65 years who underwent MMA embolization for the treatment of NASHs between November 2017 and February 2020. Patient demographics, comorbidities, clinical and radiographic factors, treatment factors, and clinical outcomes were abstracted. Subgroup analysis was performed comparing elderly (age 65–79 years) and advanced elderly (age > 80 years) patients.RESULTSMMA embolization was successfully performed in 98% of NASHs (in 148 of 151 cases) in 121 patients. Seventy elderly patients underwent 87 embolization procedures, and 51 advanced elderly patients underwent 64 embolization procedures. Elderly and advanced elderly patients had similar rates of embolization for upfront (46% vs 61%), recurrent (39% vs 33%), and prophylactic (i.e., with concomitant surgical intervention; 15% vs 6%) NASH treatment. Transfemoral access was used in most patients, and the procedure time was approximately 1 hour in both groups. Particle embolization with supplemental coils was most common, used in 51% (44/87) and 44% (28/64) of attempts for the elderly and advanced elderly groups, respectively. NASH thickness decreased significantly from initial thickness to 6 weeks, with additional decrease in thickness observed in both groups at 90 days. At longest follow-up, the treated NASHs had stabilized or improved in 91% and 98% of the elderly and advanced elderly groups, respectively, with > 50% improvement seen in > 60% of patients for each group. Surgical rescue was necessary in 4.6% and 7.8% of cases, and the overall mortality was 8.6% and 3.9% for elderly and advanced elderly patients, respectively.CONCLUSIONSMMA embolization can be used safely and effectively as an alternative or adjunctive minimally invasive treatment for NASHs in elderly and advanced elderly patients.
BACKGROUND:Minimally invasive surgery procedures, including stereotactic catheter aspiration and clearance of intracerebral hemorrhage (ICH) with recombinant tissue plasminogen activator hold a promise to improve outcome of supratentorial brain hemorrhage, a morbid and disabling type of stroke. A recently completed Phase III randomized trial showed improved mortality but was neutral on the primary outcome (modified Rankin scale score 0 to 3 at 1 yr). OBJECTIVE: To assess surgical performance and its impact on the extent of ICH evacuation and functional outcomes. METHODS: Univariate and multivariate models were used to assess the extent of hematoma evacuation efficacy in relation to mRS 0 to 3 outcome and postulated factors related to patient, disease, and protocol adherence in the surgical arm (n = 242) of the MISTIE trial. RESULTS: Greater ICH reduction has a higher likelihood of achieving mRS of 0 to 3 with a minimum evacuation threshold of ≤15 mL end of treatment ICH volume or ≥70% volume reduction when controlling for disease severity factors. Mortality benefit was achieved at ≤30 mL end of treatment ICH volume, or >53% volume reduction. Initial hematoma volume, history of hypertension, irregular-shaped hematoma, number of alteplase doses given, surgical protocol deviations, and catheter manipulation problems were significant factors in failing to achieve ≤15 mL goal evacuation. Greater surgeon/site experiences were associated with avoiding poor hematoma evacuation. CONCLUSION: This is the first surgical trial reporting thresholds for reduction of ICH volume correlating with improved mortality and functional outcomes. To realize the benefit of surgery, protocol objectives, surgeon education, technical enhancements, and case selection should be focused on this goal.
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