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Comparison of revascularization and conservative treatment for hemorrhagic moyamoya disease in East Asian Countries: a single-center case series and a systematic review with meta-analysis
Zhang, X. H., He, J. H., Zhang, X. S., Zhang, J., Wang, C. J., Dong, Y. P., Tao, W.
Frontiers in neurology. 2023;14:1169440
Abstract
OBJECTIVE The optimal treatment approach for hemorrhagic moyamoya disease (HMMD) remains a topic of debate, particularly regarding the comparative efficacy of revascularization versus conservative treatment. Our study, which included a single-center case series and a systematic review with meta-analysis, aimed to determine whether surgical revascularization is associated with a significant reduction in postoperative rebleeding, ischemic events, and mortality compared to conservative treatment among East Asian HMMD patients. METHODS We conducted a systematic literature review by searching PubMed, Google Scholar, Wanfang Med Online (WMO), and the China National Knowledge Infrastructure (CNKI). The outcomes of surgical revascularization and conservative treatment, including rebleeding, ischemic events and mortality, were compared. The authors' institutional series of 24 patients were also included and reviewed in the analysis. RESULTS A total of 19 East Asian studies involving 1,571 patients as well as our institution's retrospective study of 24 patients were included in the study. In the adult patients-only studies, those who underwent revascularization had significantly lower rates of rebleeding, ischemic events, and mortality compared to those who received conservative treatment (13.1% (46/352) vs. 32.4% (82/253), P < 0.00001; 4.0% (5/124) vs. 14.9% (18/121), P = 0.007; and 3.3% (5/153) vs. 12.6% (12/95), P = 0.01, respectively). In the adult/pediatric patients' studies, similar statistical results of rebleeding, ischemic events, and mortality have been obtained (70/588 (11.9%) vs. 103/402 (25.6%), P = 0.003 or <0.0001 in a random or fixed-effects model, respectively; 14/296 (4.7%) vs. 26/183 (14.2%), P = 0.001; and 4.6% (15/328) vs. 18.7% (23/123), P = 0.0001, respectively). CONCLUSION The current single-center case series and systematic review with meta-analysis of studies demonstrated that surgical revascularization, including direct, indirect, and a combination of both, significantly reduces rebleeding, ischemic events, and mortality in HMMD patients in the East Asia region. More well-designed studies are warranted to further confirm these findings.
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The outcomes of combined endoscopic surgery and fibrinolytic treatment protocol for intraventricular hemorrhage: a randomized controlled trial
Noiphithak R, Ratanavinitkul W, Yindeedej V, Nimmannitya P, Yodwisithsak P
World neurosurgery. 2023
Abstract
BACKGROUND Intraventricular fibrinolysis (IVF) and endoscopic surgery (ES) are the new promising treatment strategies to enhance the rate of hematoma clearance which might improve functional outcome. This study investigated and compared the outcomes among these interventions. METHODS A randomized (1:1) double-blinded trial was carried out between August 2018 and December 2021. The intervention and control groups comprised patients receiving IVF and/or ES, and external ventricular drainage (EVD), respectively. All participants had experienced primary or secondary IVH from spontaneous intracerebral hemorrhage with obstructive hydrocephalus complications. The primary outcome was modified Rankin scale (mRS) score at 180 days post-treatment. Interim assessments were planned for every 50 participants enrolled to ensure safety and efficacy. RESULTS After enrollment of 110 participants (55 participants in each group), there was the difference in 30-day mortality (2 [3.6%] vs 13 [32.7%] in EVD group, p = 0.002), reaching the predetermined boundaries for the termination of the trial. We demonstrated a better favorable outcome (mRS 0-3) at 180 days in the intervention group, compared to control group (35 [63.6%] vs. 24 [43.6%], p = 0.04). Participants in the intervention group experienced a higher IVH removal rate (91% [9.0] vs. 69.5% [38.0], p < 0.01), and had lower shunt conversion (1 [1.8%] vs. 16 [29.3%], p < 0.01). Treatment complications were comparable between the two groups. CONCLUSIONS This study demonstrated that combined ES and IVF is safe and effective for the treatment of IVH. In addition, it concluded that aggressive but safe procedures used to remove IVH could improve clinical outcome in patients with IVH.
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Optimal Hemostatic Band Duration After Transradial Angiography or Intervention: Insights From a Mixed Treatment Comparison Meta-Analysis of Randomized Trials
Maqsood, M. H., Pancholy, S., Tuozzo, K. A., Moskowitz, N., Rao, S. V., Bangalore, S.
Circulation. Cardiovascular Interventions. 2023;16(2):e012781
Abstract
BACKGROUND The optimal duration of hemostatic compression post transradial access is controversial. Longer duration increases the risk of radial artery occlusion (RAO) while shorter duration increases the risk of access site bleeding or hematoma. As such, a target of 2 hours is typically used. Whether a shorter or longer duration is better is not known. METHODS A PubMed, EMBASE, and clinicaltrials.gov databases were searched for randomized clinical trials of different duration (<90 minutes, 90 minutes, 2 hours, and 2-4 hours) of hemostasis banding. The efficacy outcome was RAO, primary safety outcome was access site hematoma, and secondary safety outcome was access site rebleeding. Primary analysis compared the effect of various duration in reference to the 2 hours duration using a mixed treatment comparison meta-analysis. RESULTS Of the 10 randomized clinical trials included with 4911 patients, when compared to the 2-hour reference duration, there was a significantly higher risk of access site hematoma with 90 minutes (odds ratio, 2.39 [95% CI, 1.40-4.06]) and <90 minutes (odds ratio, 3.61 [95% CI, 1.79-7.29]) but not with the 2 to 4 hours duration. When compared with the 2-hour reference, there was no significant difference in access site rebleeding or RAO with shorter or longer duration but the point estimates favored longer duration for access site rebleeding and shorter duration for RAO. Duration of <90 minutes and 90 minutes ranked 1 and duration of 2 hours ranked 2 as the most efficacious duration whereas duration of 2 hours ranked 1 and 2 to 4 hours ranked 2 as the safest duration. CONCLUSIONS In patients undergoing transradial access for coronary angiography or intervention, a hemostasis duration of 2 hours offers the best balance for efficacy (prevention of RAO) and safety (prevention of access site hematoma/rebleeding).
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Neuroendoscopic evacuation improves outcomes compared to external ventricular drainage in patients with spontaneous intraventricular hemorrhage: a systematic review with meta-analyses
Mezzacappa FM, Weisbrod LJ, Schmidt CM, Surdell D
World neurosurgery. 2023
Abstract
BACKGROUND Spontaneous intraventricular hemorrhage (IVH) is a cause of significant morbidity and mortality. Treatment for the resulting obstructive hydrocephalus has traditionally been via an external ventricular drain (EVD). We aimed to compare patient outcomes after neuroendoscopic surgery (NES) evacuation of IVH versus EVD management. METHODS MEDLINE, EMBASE, and the Cochrane Library were searched on October 8, 2022, with adherence to PRISMA guidelines. Of the 252 records remaining after removal of duplicates, 12 met the study's inclusion criteria. After extraction of outcomes data, fixed-effects and random-effects models were used to establish odds-ratios with 95% confidence intervals (CIs) for intensive care-unit (ICU) length-of-stay (LOS), rate of permanent cerebrospinal fluid (CSF) diversion, Glasgow Outcomes Scale (GOS) score, and mortality rate. RESULTS The results of the pooled analysis showed that ICU LOS was shorter (OR -2.61 [95% CI -5.02, -0.19]; I(2)=97.76%; p=0.034), permanent CSF diversion was less likely (OR -0.79 [95% CI -1.17, -0.41]; I(2)=46.96%; p<0.001), higher GOS was more likely (OR 0.48 [95% CI 0.04, 0.93]; I(2)=60.12%; p=0.032), and all-cause mortality was less likely (OR -1.11 [95% CI -1.79, -0.44]; I(2)=0%; p=0.001) in the NES evacuation group compared to the EVD group. CONCLUSIONS NES for evacuation of spontaneous IVH results in reduced ICU LOS, reduced permanent CSF diversion rates, improved GOS, and reduced mortality when compared with EVD. More robust prospective, randomized studies are necessary to help inform the safety and utility of NES for IVH.
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Intraventricular Hemorrhage Expansion in the CLEAR III Trial: A Post Hoc Exploratory Analysis
Roh DJ, Asonye IS, Carvalho Poyraz F, Magid-Bernstein JR, Joiner EF, Avadhani R, Awad I, Hanley DF, Ziai WC, Murthy SB
Stroke. 2022;:Strokeaha121037438
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Abstract
BACKGROUND The objective of this study was to evaluate factors associated with intraventricular hemorrhage (IVH) expansion and its association with long-term outcomes. METHODS We performed a post hoc analysis of the international, multi-center CLEAR III trial (Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage) which enrolled IVH patients between September 1, 2009, and January 31, 2015. The exposure was IVH expansion, defined as >1 mL increase in volume between baseline and stability computed tomography scans, before treatment randomization. We assessed factors associated with IVH expansion and secondarily assessed the relationship of IVH expansion with clinical outcomes: composite of death or major disability (modified Rankin Scale score, >3), and mortality alone at 6 months. The relationship of IVH expansion on ventriculoperitoneal shunt placement was additionally explored. Multivariable logistic regression was used for all analyses. RESULTS Of 500 IVH patients analyzed, the mean age was 59 (±11) years old, 44% were female and 135 (27%) had IVH expansion. In multivariable regression models, factors associated with IVH expansion were baseline parenchymal intracerebral hemorrhage (ICH) volume (adjusted odds ratio [OR], 1.04 per 1 mL increase [95% CI, 1.01-1.08]), presence of parenchymal hematoma expansion: >33% (adjusted OR, 6.63 [95% CI, 3.92-11.24]), time to stability head CT (adjusted OR, 0.71 per 1 hour increase [95% CI, 0.54-0.94]), and thalamic hematoma location (adjusted OR, 1.68 [95% CI, 1.01-2.79]) while additionally adjusting for age, sex, and race. In secondary analyses, IVH expansion was associated with higher odds of poor 6-month outcomes (adjusted OR, 1.84 [95% CI, 1.12-3.02]) but not mortality (OR, 1.40 [95% CI, 0.78-2.50]) after adjusting for baseline ICH volume, thalamic ICH location, age, anticoagulant use, Glasgow Coma Scale score, any withdrawal of care order, and treatment randomization arm. However, there were no relationships of IVH expansion on subsequent ventriculoperitoneal shunt placement (adjusted OR, 1.02 [95% CI, 0.58-1.80]) after adjusting for similar covariates. CONCLUSIONS In a clinical trial cohort of patients with large IVH, acute hematoma characteristics, specifically larger parenchymal volume, hematoma expansion, and thalamic ICH location were associated with IVH expansion. Given that IVH expansion resulted in poor functional outcomes, exploration of treatment approaches to optimize hemostasis and prevent IVH expansion, particularly in patients with thalamic ICH, require further study. REGISTRATION URL: https://www.clinicaltrials.gov; Unique identifier: NCT00784134.
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Endovascular treatment and neurosurgical clipping in subarachnoid hemorrhage: a systematic review of economic evaluations
Bock LA, Noben CY, van Mook WN, de Ridder IR, van Zwam WH, Schenck HE, Haeren RH, Essers BA
Journal of neurosurgical sciences. 2022
Abstract
INTRODUCTION There are two treatment modalities for aneurysmal subarachnoid hemorrhage: endovascular treatment and neurosurgical clipping. Results of economic evaluations are needed to gain insight into the relationship between clinical effectiveness and costs of these treatment modalities. This important information can inform both clinical decision-making processes and policymakers in facilitating Value-Based Healthcare. EVIDENCE ACQUISITION Databases (PubMed, Embase, Cochrane Library, the Centre for Reviews and Dissemination, EBSCO, and Web of Science) were searched for studies published until October 2020 that had performed economic evaluations in aneurysmal subarachnoid hemorrhage patients by comparing endovascular treatment with neurosurgical clipping. The quality of reporting and methodology of these evaluations was assessed using the associated instruments (i.e. CHEERS statement and CHEC-list, respectively). EVIDENCE SYNTHESIS A total of six studies met the inclusion criteria. All included studies reported both effects and costs, however five did not relate effects to costs. Only one study related effects directly to costs, thus conducted a full economic evaluation. The reporting quality scored 81% and the methodological quality scored 30%. CONCLUSIONS The quality of published cost-effectiveness studies on the treatment of aneurysmal subarachnoid hemorrhage is poor. Six studies reported both outcomes and costs, however only one study performed a full economic evaluation comparing endovascular treatment to neurosurgical clipping. Although the reporting quality was sufficient, the methodological quality was poor. Further research that relates health-related quality of life measures to costs of endovascular treatment and neurosurgical clipping is required-specifically focusing on both reporting and methodological quality. Different subgroup analyses and modeling could also enhance the findings.
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Endoscopic surgery for spontaneous supratentorial intracerebral haemorrhage: A systematic review and meta-analysis
Hallenberger TJ, Guzman R, Bonati LH, Greuter L, Soleman J
Frontiers in neurology. 2022;13:1054106
Abstract
INTRODUCTION Treatment for spontaneous supratentorial intracerebral haemorrhage (SSICH) is limited and consist of either best medical treatment (BMT) or surgical hematoma evacuation. Treatment methods and choice of surgical technique are debated, and so far, no clear advantage of endoscopic surgery (ES) over conventional craniotomy (CC) or BMT was shown. The aim of this systematic review and meta-analysis was to investigate the differences in outcome, morbidity, and mortality between ES and CC or BMT. METHODS We systematically searched Embase and PubMed databases for randomised controlled trials comparing ES to CC or BMT. The primary outcome was favourable functional outcome after 6 months. Secondary outcomes were morbidity and mortality rates and duration of surgery. RESULTS Seven articles were eligible for the outcome analysis with 312 subjects in the control (216 CC, 96 BMT) and 279 in the treatment group (ES). Compared to BMT, ES showed significantly improved favourable functional outcome (RR 1.93 [1.12; 3.33], p = 0.02) and mortality rates (RR 0.63 [0.44; 0.90], p = 0.01). No significant difference in favourable functional outcome and mortality was seen in ES compared to CC (RR 2.13 [0.01; 737], p = 0.35; RR 0.42 [0.17; 1.05], p = 0.06). ES showed significantly lower morbidity (RR 0.41 [0.29; 0.58], p < 0.01), and overall infection rates (RR 0.33 [0.20; 0.54], p < 0.01) compared to CC. Duration of surgery was significantly shorter for ES compared to CC (SMD -3.17 [-4.35; -2.00], p < 0.01). CONCLUSION ES showed significantly improved favourable functional outcome and mortality rates compared to BMT while showing reduced length of surgery and lower complication rates compared to CC. Therefore, ES appears a promising approach for treatment of SSICH justifying further prospective trials. SYSTEMATIC REVIEW REGISTRATION PROSPERO, identifier: CRD42020181018.
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Carvedilol versus endoscopic band ligation for secondary prophylaxis of variceal bleeding-Long-term follow-up of a randomised control trial
Dunne PDJ, Young D, Chuah CS, Hayes PC, Tripathi D, Leithead J, Smith LA, Gaya DR, Forrest E, Stanley AJ
Alimentary pharmacology & therapeutics. 2022
Abstract
BACKGROUND AND AIMS Carvedilol reduces rates of variceal bleeding and rebleeding by lowering portal pressure. However, an associated pleiotropic survival benefit has been proposed. We aimed to assess long-term survival in a cohort of patients previously randomised to receive either carvedilol or endoscopic band ligation (EBL) following oesophageal variceal bleeding (OVB). METHODS The index study randomised 64 cirrhotic patients with OVB between 2006 and 2011 to receive either carvedilol or EBL. Follow-up was undertaken to April 2020 by review of electronic patient records. The primary outcome was survival. Other outcomes including variceal rebleeding and liver decompensation events were compared. RESULTS 26 out of 33 participants received carvedilol in the follow-up period and 28 out of 31 attended regular EBL sessions. The median number of follow-up days for all patients recruited was 1459 (SE = 281.74). On the intention to treat analysis, there was a trend towards improved survival in the carvedilol group (p = 0.09). On per-protocol analysis, carvedilol use was associated with improved long-term survival (p = 0.005, HR 3.083, 95% CI 1.397-6.809), fewer liver-related deaths (0% vs 22.57%, p = 0.013, OR ∞, 95%CI 1.565-∞) and fewer admissions with decompensated liver disease (12% vs 64.29%, p = 0.0002, OR 13.2, 95% CI 3.026-47.23) compared to the EBL group. There was no statistically significant difference in variceal rebleeding rates. CONCLUSION Following OVB in cirrhotic patients, carvedilol use is associated with survival benefit, fewer liver-related deaths and fewer hospital admissions with decompensated liver disease. Further studies are needed to validate this finding.
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A cost-utility analysis comparing endovascular coiling to neurosurgical clipping in the treatment of aneurysmal subarachnoid haemorrhage
Ahmed A, Ahmed Y, Duah-Asante K, Lawal A, Mohiaddin Z, Nawab H, Tang A, Wang B, Miller G, Malawana J
Neurosurgical review. 2022
Abstract
Endovascular coiling (EC) has been identified in systematic reviews and meta-analyses to produce more favourable clinical outcomes in comparison to neurosurgical clipping (NC) when surgically treating a subarachnoid haemorrhage from a ruptured aneurysm. Cost-effectiveness analyses between both interventions have been done, but no cost-utility analysis has yet been published. This systematic review aims to perform an economic analysis of the relative utility outcomes and costs from both treatments in the UK. A cost-utility analysis was performed from the perspective of the National Health Service (NHS), over a 1-year analytic horizon. Outcomes were obtained from the randomised International Subarachnoid Aneurysm Trial (ISAT) and measured in terms of the patient's modified Rankin scale (mRS) grade, a 6-point disability scale that aims to quantify a patient's functional outcome following a stroke. The mRS score was weighted against the Euro-QoL 5-dimension (EQ-5D), with each state assigned a weighted utility value which was then converted into quality-adjusted life years (QALYs). A sensitivity analysis using different utility dimensions was performed to identify any variation in incremental cost-effectiveness ratio (ICER) if different input variables were used. Costs were measured in pounds sterling (£) and discounted by 3.5% to 2020/2021 prices. The cost-utility analysis showed an ICER of - £144,004 incurred for every QALY gained when EC was utilised over NC. At NICE's upper willingness-to-pay (WTP) threshold of £30,000, EC offered a monetary net benefit (MNB) of £7934.63 and health net benefit (HNB) of 0.264 higher than NC. At NICE's lower WTP threshold of £20,000, EC offered an MNB of £7478.63 and HNB of 0.374 higher than NC. EC was found to be more 'cost-effective' than NC, with an ICER in the bottom right quadrant of the cost-effectiveness plane-indicating that it offers greater benefits at lower costs. This is supported by the ICER being below the NICE's threshold of £20,000-£30,000 per QALY, and both MNB and HNB having positive values (> 0).
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Endoscopic Evacuation of Massive Intraventricular Hemorrhages Reduces Shunt Dependency: A Meta-Analysis
Fiorindi A, Saraceno G, Zanin L, Terzi di Bergamo L, Feletti A, Doglietto F, Fontanella MM
Asian journal of neurosurgery. 2022;17(4):541-546
Abstract
Intraventricular hemorrhage (IVH) is characterized by severe prognosis. The amount of intraventricular blood is the most important, disease-specific, prognostic factor, as acute complications are strictly dependent on clot formation. Although external ventricular drain (EVD) placement is the standard treatment, in the past 15 years neuroendoscopic (NE) evacuation of IVH has been advocated, but available comparative data are limited. A systematic review of the literature was performed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Included articles compare the treatment of primary and secondary IVH with NE and EVD. The meta-analysis was performed in terms of shunt dependency. Cochran's Q-test and I2 statistics were used to assess heterogeneity in the studies. No heterogeneity was considered for p greater than 0.05 and I2 less than 20%. A random-effect model was used, with restricted maximum likelihood to estimate the heterogeneity variance. After screening 744 articles, 5 were included in the meta-analysis. A total of 303 patients presenting with primary or pure (50 patients) and secondary (253 patients) IVH, undergoing either NE (151) or EVD (152), were included in the metanalysis. The risk of ventriculoperitoneal (VP) shunt was higher in the EVD group (relative risk: 1.93, 95% confidence interval: 1.28-2.92, p = 0.0094). The risk of VP shunt was higher in the EVD group, but the overall outcome remains poor for patients with IVH, with a moderate-to-high disability. Large randomized controlled trials are needed to evaluate more deeper both advantages and effects on the outcome of NE over EVD.
