Interventional outcomes for patients eligible for entry into the ARUBA clinical trial: a systematic review and meta-analysis

2021 ◽  
pp. 1-13
Author(s):  
M. Harrison Snyder ◽  
Ching-Jen Chen ◽  
Faraz Farzad ◽  
Natasha Ironside ◽  
Ryan T. Kellogg ◽  
...  

OBJECTIVE A Randomized Trial of Unruptured Brain Arteriovenous Malformations (ARUBA) suggested that medical management afforded outcomes superior to those following intervention for unruptured arteriovenous malformations (AVMs), but its findings have been controversial. Subsequent studies of AVMs that would have met the eligibility requirements of ARUBA have supported intervention for the management of some cases. The present meta-analysis was conducted with the object of summarizing interventional outcomes for ARUBA-eligible patients reported in the literature. METHODS A systematic literature search (PubMed, Web of Science, Google Scholar) for AVM intervention studies that used inclusion criteria identical to those of ARUBA (age ≥ 18 years, no history of AVM hemorrhage, no prior intervention) was performed. The primary outcome was death or symptomatic stroke. Secondary outcomes included AVM obliteration, hemorrhage, death, and poor outcome (modified Rankin Scale score ≥ 2 at final follow-up). Bias assessment was performed with the Newcastle-Ottawa Scale, and the results were synthesized as pooled proportions. RESULTS Of the 343 articles identified through database searches, 13 studies met the inclusion criteria, yielding an overall study cohort of 1909 patients. The primary outcome occurred in 11.2% of patients (pooled = 11%, 95% CI 8%–13%). The rates of AVM obliteration, hemorrhage, poor outcome, and death were 72.7% (pooled = 78%, 95% CI 70%–85%), 8.4% (pooled = 8%, 95% CI 6%–11%), 9.9% (pooled = 10%, 95% CI 7%–13%), and 3.5% (pooled = 2%, 95% CI 1%–4%), respectively. Annualized primary outcome and hemorrhage risks were 1.85 (pooled = 2.05, 95% CI 1.31–2.94) and 1.34 (pooled = 1.41, 95% CI 0.83–2.13) per 100 patient-years, respectively. CONCLUSIONS Intervention for unruptured AVMs affords acceptable outcomes for appropriately selected patients. The risk of hemorrhage following intervention compared favorably to the natural history of unruptured AVMs. The included studies were retrospective and varied in treatment and AVM characteristics, thereby limiting the generalizability of their data. Future studies from prospective registries may clarify patient, nidus, and intervention selection criteria that will refine the challenging management of patients with unruptured AVMs.

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yaping Wang ◽  
Bin Liu ◽  
Xiuqiong Fu ◽  
Tiejun Tong ◽  
Zhiling Yu

Abstract Background The traditional Chinese medicine formula Si-Jun-Zi-Tang (SJZT) has a long history of application in the treatment of functional dyspepsia (non-ulcer dyspepsia, FD)-like symptoms. SJZT-based therapies have been claimed to be beneficial in managing FD. This study aimed to assess the efficacy and safety of SJZT-based therapies in treating FD by meta-analysis. Methods Systematic searches for RCTs were conducted in seven databases (up to February 2019) without language restrictions. Data were analyzed using Cochrane RevMan software version 5.3.0 and Stata software version 13.1, and reported as relative risk (RR) or odds ratio (OR) with 95% confidence intervals (CIs). The primary outcome was response rate and the secondary outcomes were gastric emptying, quality of life, adverse effects and relapse rate. The quality of evidence was evaluated according to criteria from the Cochrane risk of bias. Results A total of 341 potentially relevant publications were identified, and 12 RCTs were eligible for inclusion. For the response rate, there was a statically significant benefit in favor of SJZT-based therapies (RR = 1.23; 95% CI 1.17 to 1.30). However, the benefit was limited to modified SJZT (MSJZT). The relapse rate of FD patients received SJZT-based therapies was lower than that of patients who received conventional medicines (OR = 0.23; 95% CI 0.10 to 0.51). No SJZT-based therapies-related adverse effect was reported. Conclusion SJZT-based prescriptions may be effective in treating FD and no serious side-effects were identified, but the effect on response rate appeared to be limited to MSJZT. The results should be interpreted with caution as all the included studies were considered at a high risk of bias. Standardized, large-scale and strictly designed RCTs are needed to further validate the benefits of SJZT-based therapies for FD management. Trial registration Systematic review registration: [PROSPERO registration: CRD42019139136].


Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Ching-jen Chen ◽  
Cheng-Chia Lee ◽  
Hideyuki Kano ◽  
Kathryn Kearns ◽  
Dale Ding ◽  
...  

Background and Purpose: To evaluate, in a multicenter, retrospective cohort study, the outcomes after stereotactic radiosurgery (SRS) for unruptured, intervention-naïve pediatric brain arteriovenous malformations (AVM). Methods: We retrospectively analyzed the International Radiosurgery Research Foundation pediatric AVM database from 1987-2018. Pediatric patients with unruptured, previously untreated AVMs who underwent SRS were included. The primary endpoint was a composite of hemorrhagic stroke, death, or permanently symptomatic radiation-induced changes (RIC). Results: The study cohort comprised 101 patients (mean follow-up 80.8 months). The primary endpoint occurred in 14%, comprising hemorrhage stroke, death, and permanent RIC in 6%, 3%, and 8%, respectively. Estimated probabilities of the primary endpoint were 5.2%, 10.8%, and 23.0% at 2, 5, and 10 years, respectively (Figure 1). Estimated probabilities of AVM obliteration at 5 and 10 years were 64% and 82%, respectively (Figure 2). Single SRS treatment (p=0.007) and higher margin dose (p=0.005) were predictors of obliteration. Subgroup analysis of Spetzler-Martin grade I-III AVMs estimated primary endpoint probabilities of 3.7%, 8.4%, and 18.7% at 2, 5 and 10 years, respectively. Conclusion: Treatment of unruptured, intervention-naïve AVMs in the pediatric population with SRS carries an approximately 2% annual risk of morbidity and mortality, which appears to plateau after 10 years. The poorly described natural history of pediatric AVMs makes any comparison of SRS versus conservative management imperfect. However, due to the young age at diagnosis and excessive cumulative life hemorrhage risk of an untreated AVM in a child, SRS is likely to have a favorable long-term risk-benefit profile for appropriately selected unruptured pediatric AVMs.


Author(s):  
David C. Lauzier ◽  
Ananth K. Vellimana ◽  
Arindam R. Chatterjee ◽  
Joshua W. Osbun ◽  
Christopher J. Moran ◽  
...  

OBJECTIVE Brain arteriovenous malformations (AVMs) carry a risk of rupture and subsequent morbidity or mortality unless fully treated. AVMs in pediatric patients are known to occasionally recur after obliteration. The objective of this study was to characterize the risk of AVM recurrence following angiographically confirmed obliteration in children. METHODS Consecutive pediatric AVMs treated at a single center were identified from a prospective database. Patients with angiographically confirmed AVM obliteration following treatment were included in this study. Associations between AVM recurrence and patient or procedural factors were characterized using the two-tailed Fisher exact test or Mann-Whitney U-test. A literature search was conducted using PubMed, Scopus, Embase, and the Clarivate Web of Science with defined search criteria, and eligible studies were included alongside this study cohort in a meta-analysis. Rates of AVM recurrence following obliteration were pooled across studies with a random-effects model and reported with 95% confidence intervals (CIs). RESULTS Recurrence after angiographic confirmation of AVM obliteration was observed in 10.4% (7/67) of pediatric AVMs treated at the authors’ center. Patients with recurrent AVMs were significantly younger than those without recurrence (p = 0.002). In the meta-analysis, which included 1134 patients across 24 studies, the rate of recurrence was 4.8% (95% CI 3.0%–6.7%). The rate of AVM recurrence following radiosurgery was 0.7% (95% CI 0%–1.6%), which was significantly lower than the 8.5% rate (95% CI 5.0%–12.0%) following microsurgery. CONCLUSIONS Recurrence of obliterated brain AVMs is common in children. Recurrence is more common in young children and following microsurgery.


2014 ◽  
Vol 2014 ◽  
pp. 1-10 ◽  
Author(s):  
Shu-huai Xing ◽  
Chun-xiao Zhu ◽  
Rui Zhang ◽  
Li An

The objective of our study was to perform an updated meta-analysis of placebo-controlled RCTs of Huperzine A (Hup A) on patients with Alzheimer's disease (AD) and vascular dementia (VD), in order to provide the basis and reference for clinical rational drug use. The primary outcome measures assessed were minimental state examination (MMSE) and activities of daily living scale (ADL). Eight AD trials with 733 participants and two VD trials with 92 participants that met our inclusion criteria were identified. The results showed that Hup A could significantly improve the MMSE and ADL score of AD and VD patients, and longer durations would result in better efficacy for the patients with AD. It seemed that there was significant improvement of cognitive function measured by memory quotient (MQ) in patients with AD. Most adverse effects in AD were generally of mild to moderate severity and transient. Compared to the patients with AD, Hup A may offer fewer side effects for participants with VD in this study. Therefore, Hup A is a well-tolerated drug that could significantly improve cognitive performance in patients with AD or VD, but we need to use it with caution in the clinical treatment.


Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Eva A Mistry ◽  
Akshitkumar M Mistry ◽  
Mohammad O Nakawah ◽  
John Volpi

Background: Presently, no evidence exists that blood pressure parameters (BPPs) in the first 24-hours after thrombectomy (T24hrs) independently predicts outcome. We aimed to study an association between discharge outcome and BPPs in T24hrs for both successful and unsuccessful thrombectomies, defined as Thrombolysis in Cerebral Infarction (TICI) score ≥ 2b and ≤ 2a, respectively. Methods: We retrospectively identified 54 patients at a single institution who underwent thrombectomy for emergent occlusion of anterior cerebral circulation (ICA, A1, M1, M2) from May 2015 to June 2016. We excluded patients with cancer or major cardiovascular surgeries. Primary outcome was hospital discharge: home or rehab (favorable) versus long term acute care facility or death (unfavorable). We determined if highest, lowest, average, and range of systolic (SBP), diastolic (DBP), and mean arterial (MAP) pressures were associated with outcome, utilizing univariate and multivariate logistic regression considering the following variables: age, sex, NIH-stroke scale, history of hypertension, hyperlipidemia, diabetes, smoking, atrial fibrillation, use of anticoagulative or antiplatelet medications prior to admission, administration of tPA, and the use of antihypertensive or pressor drip in T24hrs. Results: In patients with TICI ≥ 2b (n=43), highest SBP (odds ratio=1.04, p=0.01), highest MAP (1.05, p=0.03), SBP range (1.04, p=0.005), and MAP range (1.05, p=0.03) correlated with poor outcome. In multivariate analysis, only the SBP range trended with outcome (1.34, p=0.09). In patients with TICI ≤ 2a (n=11), BPPs did not correlate with outcome. Conclusion: Large variability in SBP in T24hrs after successful thrombectomies (TICI ≥ 2b) trended with poor outcome. Further studies are warranted to elucidate BPPs in T24hrs as predictors of hospital discharge.


2017 ◽  
Vol 52 (1) ◽  
pp. 54-59 ◽  
Author(s):  
Caitlin M. Gibson ◽  
Carmen B. Smith ◽  
Sondra Davis ◽  
Michael J. Scalese

Background: Apixaban is a direct oral anticoagulant (DOAC) for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). Other DOACs require renal dose adjustments based solely on creatinine clearance. Apixaban differs in that its dose adjustments are more complex, potentially leading to prescribing errors. Objective: To determine if adherence to Food and Drug Administration (FDA)-approved dosing for apixaban is maintained in hospitalized patients with NVAF. Methods: Patients ≥18 years old with NVAF who received apixaban during admission to 1 of 3 hospitals were evaluated. The primary outcome was to determine if providers order apixaban in accordance with FDA-approved dosages. Secondary outcomes included determining if pharmacist review increased the number of orders in accordance with FDA-approved dosing, which of the 3 criteria (age ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dL) were met in patients receiving off-label dosing, and the rationale for off-label prescribing. Results: A total of 556 patients met inclusion criteria. Apixaban was dosed according to FDA labeling by providers in 83.4% (n = 464) of orders. After pharmacist review, 87.0% (n = 484) of orders were at the approved dose, 12.2% (n = 68) were underdosed, and 0.7% (n = 4) were overdosed. Most patients who were underdosed met only 1 dose reduction criterion—most commonly age ≥80 years (56.0%). Reasons for off-label dosing included home dose continuation (39.0%), history of or perceived bleeding risk (30.5%), or unspecified/other (30.5%). Conclusions: The majority of apixaban orders for NVAF were based on FDA-approved dosages after provider entry and pharmacist review.


2018 ◽  
Vol 23 (suppl_1) ◽  
pp. e45-e46
Author(s):  
Souvik Mitra ◽  
Helen McCord ◽  
Mohamed El Azrak ◽  
Bosco Paes

Abstract BACKGROUND Down syndrome (DS) is associated with a number of immunologic abnormalities and congenital heart disease (CHD) which increase susceptibility to respiratory syncytial virus (RSV). However current position statements from the American Academy of Pediatrics and the Canadian Paediatric Society do not recommend routine RSV prophylaxis with Palivizumab to all infants with DS, OBJECTIVES To conduct a systematic reviewand meta-analysis of observational studies to compare RSV-related hospitalization (RSVH) rates, length of hospital stay(LOS), need for intensive care and assisted ventilation in DS children <2 years of age compared with children without DS. DESIGN/METHODS Data Sources: The authors searched MEDLINE, Embase, CINAHL, reference lists of relevant articles, abstracts and conference proceedings, results of unpublished trials, and contacted the primary authors of relevant studies. Studies were included if data was provided on RSV-related hospitalization in children <2yr of age with and without DS. Data extraction & Synthesis: Two reviewers independently screened the search results, applied inclusion criteria and assessed methodological quality using the Newcastle-Ottawa Scale. Data was extracted and checked in duplicate. Main outcomes & measures: The primary outcome was RSV-related hospitalization. Secondary outcomes included length of hospital stay, need for intensive care and assisted ventilation. Sensitivity analysis was conducted for the primary outcome comparing DS infants without congenital heart disease (CHD) with non-DS infants. RESULTS 19 cohort studies met the inclusion criteria. Ten studies involving 1,390,380 children were analyzed. DS-children had significantly higher RSVH compared to non-DS children (Relative Risk, 6.97; 95% CI, 6.01 to 8.08; I2=0%; Figure 1a). Among children hospitalized with RSV, need for assisted ventilation (RR, 5.82; 95% CI, 1.81 to 18.69; I2=84%; Figure 1b) and LOS (Mean difference, 2.28 days; 95% CI, 1.61 to 2.96 days; I2=0%; Figure 1c) were significantly higher in DS-children. The sensitivity analysis also confirmed that DS children without CHD had a significantly higher RSVH rate compared to non-DS children (RR, 6.31; 95% CI, 4.83 to 8.23;I2=0%; Figure 1d). CONCLUSION Compared to children without DS, RSV-related hospitalization, need for assisted ventilation and length of RSV-related hospital stay is significantly higher in children with DS in the first 2 years of life. The results of this systematic review should prompt a favorable recommendation for routine RSV prophylaxis in both healthy and medically compromised DS children aged <2years.


2020 ◽  
Vol 9 (12) ◽  
pp. 3933
Author(s):  
Liran Hiersch ◽  
Yael Pasternak ◽  
Nir Melamed ◽  
Moshe Meshulam ◽  
Reut Shashar ◽  
...  

Background: We aimed to explore the association of the number, order, gestational age and type of prior PTB and the risk of preterm birth (PTB) in the third delivery in women who had three consecutive singleton deliveries. Methods: A retrospective cohort study of all women who had three consecutive singleton births at a single medical center over a 20-year period (1994–2013). The primary outcome was PTB (<37 weeks) in the third delivery. Results: 4472 women met inclusion criteria. The rate of PTB in the third delivery was 4.9%. In the adjusted analysis, the risk of PTB was 3.5% in women with no prior PTBs; 10.9% in women with prior one PTB only in the first pregnancy; 16.2% in women with prior one PTB only in the second pregnancy; and 56.5% in women with prior two PTBs. A similar trend was observed when the outcome of interest was spontaneous PTB and when the exposure was limited to prior spontaneous or indicated PTB. Conclusions: In women with a history of PTB, the risk of recurrent PTB in subsequent pregnancies is related to the number and order of prior PTBs. These factors should be taken into account when stratifying the risk of PTB.


2020 ◽  
pp. 20201039
Author(s):  
Manish Devendra Devendra Mair ◽  
Mohammed Hussain ◽  
Saad Siddiqui ◽  
Sudip Das ◽  
Andrew Baker ◽  
...  

Objective: To perform a systematic review and meta-analysis to compare the diagnostic accuracy of Computed tomography (CT) and initial Reverse transcriptase polymerase chain reaction (RT-PCR) for detecting COVID-19 infection. Methods: We searched three databases, PubMed, EMBASE and EMCARE to identify studies reporting diagnostic accuracy of both CT and RT-PCR in detecting COVID-19 infection between December 2019 and May 2020. For accurate comparison, only those studies which had patients undergoing both, CT and RT-PCR were included. Pooled diagnostic accuracy of both the tests was calculated by using a bivariate random effects model. Results: Based on inclusion criteria, only 11 studies consisting of 1834 patients were included in the final analysis that reported diagnostic accuracy of both CT and RT-PCR, in the same set of patients. Sensitivity estimates for CT scan ranged from 0.69 to 1.00 and for RT-PCR varied ranging from 0.47 to 1.00. The pooled estimates of sensitivity for CT and RT-PCR was 0.91 [95% CI (0.84–0.97)] and 0.84 [95% CI (0.71–0.94)] respectively. On subgroup analysis, pooled sensitivity of CT and RT-PCR was 0.95 [95% CI (0.88–0.98)] and 0.91 [95% CI (0.80–0.96), p = o.ooo1]. The pooled specificity of CT and RT-PCR was 0.31 [95% CI (0.035–0.84)] and 1.00 [95% CI (0.96–1.00)]. Conclusion: CT is more sensitive than RT-PCR in detecting COVID-19 infection, but has a very low specificity. Advances in knowledge: Since the results of a CT scan are available quickly, it can be used as an adjunctive initial diagnostic test for patients with a history of positive contact or epidemiological history.


1996 ◽  
Vol 84 (6) ◽  
pp. 912-919 ◽  
Author(s):  
William A. Friedman ◽  
David L. Blatt ◽  
Frank J. Bova ◽  
John M. Buatti ◽  
William M. Mendenhall ◽  
...  

✓ Two hundred and one patients with arteriovenous malformations (AVMs) treated radiosurgically between May 1988 and February 1995 are analyzed in this study. Twelve patients sustained a posttreatment hemorrhage during this period. Pretreatment factors associated with increased hemorrhage risk were identified in 11 of these patients and included arterial aneurysms, venous aneurysms, venous outflow obstruction, periventricular location, prior embolization, and prior surgical treatment. A detailed statistical analysis, using both Poisson regression and parametric survival regression techniques, was undertaken to determine whether radiosurgery had any effect on the risk of hemorrhage, when compared to the natural history of the disease, in those patients in whom a complete angiographic cure was not achieved. No evidence was found to support a statistically significant departure from the natural hemorrhage rate at any time period after radiosurgical treatment. Significant risk factors for hemorrhage appeared to correlate with increasing AVM volume.


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