IN.PACT AV Access Trial: Economic Evaluation of Drug-Coated Balloon Treatment for Dysfunctional Arteriovenous Fistulae Based on 12-Month Clinical Outcomes

PurposeTo study, from a U.S. payer’s perspective, the economic consequences of drug-coated balloon (DCB) versus standard percutaneous transluminal angioplasty (PTA) use for the treatment of stenotic lesions in dysfunctional hemodialysis arteriovenous fistulae.Materials and MethodsCost differences between DCBs and PTA at year 1 and beyond were calculated via 2 methods. The first approach used the mean absolute number of trial-observed access circuit reinterventions through 12 months (0.65 ± 1.05 vs 1.05 ± 1.18 events per patient for DCBs and PTA, respectively) and projected treatment outcomes to 3 years. The second approach was based on the trial-observed access circuit primary patency rates at 12 months (53.8% vs 32.4%) and calculated the cost difference on the basis of previously published Medicare cost for patients who maintained or did not maintain primary patency. Assumptions regarding DCB device prices were tested in sensitivity analyses, and the numbers needed to treat were calculated.ResultsUsing the absolute number of access circuit reinterventions approach, the DCB strategy resulted in an estimated per-patient savings of $1,632 at 1 year and $4,263 at 3 years before considering the DCB device cost. The access circuit primary patency approach was associated with a per-patient cost savings of $2,152 at 1 year and $3,894 at 2.5 years of follow-up. At the theoretical DCB device reimbursement of $1,800, savings were $1,680 and $2,049 at 2.5 and 3 years, respectively. The one-year NNT of DCB compared to PTA was 2.48.ConclusionsEndovascular therapy for arteriovenous access stenosis with the IN.PACT AV DCB can be expected to be cost-saving if longer follow-up data confirm its clinical effectiveness.     

Alzheimer's Disease THErapy With NEuroaid (ATHENE): A Randomized Double-Blind Delayed-Start Trial

ObjectivesPreclinical and clinical studies indicate a role for MLC901 (NeuroAiD II) in Alzheimer's disease (AD). The primary aim was to investigate its safety as add-on therapy to standard treatment and the secondary aims its effect on cognition and slowing disease progression.DesignRandomized double-blind placebo-controlled delayed-start study.Setting and ParticipantPatients with mild to moderate probable AD by NINCDS-ADRDA criteria, stable on acetylcholinesterase inhibitors or memantine (n = 125), were randomized to receive MLC901 (early starters) or placebo (delayed starters) for 6 months, followed by a further 6 months when all patients received MLC901, in a delayed-start design (clinical trial registration: ClinicalTrials.gov, NCT03038035).MethodsThe primary outcome measure was occurrence of serious adverse events (SAEs) at 6 months. Secondary outcomes included the Alzheimer's Disease Assessment Scale–Cognitive subscale (ADAS-Cog) and other assessment scales.ResultsThere was no significant difference in the risk of SAEs between early and delayed starters at month (M) 6 (22.6% vs 27.0%, risk difference ?4.4%, 90% CI –16.9% to 8.3%). Similarly, there was no significant difference in the risk of adverse events and the occurrence of stroke or vascular events between early and delayed starters throughout the 12-month study period. Early starters did not differ significantly on ADAS-Cog from delayed starters at M6 [mean difference (MD) ?1.0, 95% CI –3.3 to 1.3] and M12 (MD –2.35, 95% CI –5.45 to 0.74) on intention-to-treat analysis. Other cognitive assessment scales did not show significant differences.Conclusions and ImplicationsThis study of 125 persons with dementia found no evidence of a significant increase in adverse events between MLC901 and placebo, thus providing support for further studies on both efficacy and safety. Analyses suggest the potential of MLC901 in slowing down AD progression, but this requires further confirmation in larger and longer studies using biomarkers for AD.     

OCT及OCTA在阿尔茨海默病诊断中的研究进展

阿尔茨海默病是一种进行性且不可逆转的神经系统疾病,由于视网膜和中枢神经系统有相似的胚胎起源和生理特征,眼科检查可提供简单无创的诊断方法。光学相干断层扫描技术(OCT)能够精确地测量视网膜各个组织层面的厚度,以评估视网膜的退行性改变,光学相干断层扫描血管成像(OCTA)可以提供高分辨率三维成像,从而更直观地检测视网膜血管的变化,间接地反映脑神经元和血管的病理特征。就OCT测量视网膜厚度及OCTA测量视网膜血流变化在阿尔茨海默病诊断中的研究进展进行综述。     

Hirschsprung-associated inflammatory bowel disease: A multicenter study from the APSA Hirschsprung disease interest group

Background/PurposeA small number of Hirschsprung disease (HD) patients develop inflammatory bowel disease (IBD)-like symptoms after pullthrough surgery. The etiology and pathophysiology of Hirschsprung-associated IBD (HD-IBD) remains unknown. This study aims to further characterize HD-IBD, to identify potential risk factors and to evaluate response to treatment in a large group of patients.MethodsRetrospective study of patients diagnosed with IBD after pullthrough surgery between 2000 and 2021 at 17 institutions. Data regarding clinical presentation and course of HD and IBD were reviewed. Effectiveness of medical therapy for IBD was recorded using a Likert scale.ResultsThere were 55 patients (78% male). 50% (n = 28) had long segment disease. Hirschsprung-associated enterocolitis (HAEC) was reported in 68% (n = 36). Ten patients (18%) had Trisomy 21. IBD was diagnosed after age 5 in 63% (n = 34). IBD presentation consisted of colonic or small bowel inflammation resembling IBD in 69% (n = 38), unexplained or persistent fistula in 18% (n = 10) and unexplained HAEC >5 years old or unresponsive to standard treatment in 13% (n = 7). Biological agents were the most effective (80%) medications. A third of patients required a surgical procedure for IBD.ConclusionMore than half of the patients were diagnosed with HD-IBD after 5 years old. Long segment disease, HAEC after pull through operation and trisomy 21 may represent risk factors for this condition. Investigation for possible IBD should be considered in children with unexplained fistulae, HAEC beyond the age of 5 or unresponsive to standard therapy, and symptoms suggestive of IBD. Biological agents were the most effective medical treatment.Level of EvidenceLevel 4     

冠状动脉慢血流的危险因素及冠状动脉病变特点的研究

目的研究冠状动脉慢血流现象(CSFP)患者的危险因素和分析累及冠状动脉病变的特点。方法回顾性收集本院2019年1月—2021年1月因疑似冠心病行冠状动脉造影术的514例患者,分析患者的临床资料、实验室指标及冠状动脉造影结果等相关资料,按照TIMI血流分级分为慢血流组(n=288)和对照组(n=226),比较两组之间的差异,并通过logistics回归分析探讨CSFP患者的危险因素。结果 (1)两组间在性别、民族、吸烟及饮酒史上存在统计学差异(P<0.05)。(2)CSFP组的血红蛋白、游离三碘甲状原氨酸、血肌酐值、血尿酸水平、空腹血糖水平和左室舒张末期大小均高于对照组(P<0.05);而CSFP组的血小板分布宽度、游离甲状腺素、总胆固醇、高密度脂蛋白胆固醇、低密度脂蛋白胆固醇、载脂蛋白A1和白蛋白水平均低于对照组(P<0.05);(3)CSFP以三支血管病变最多见,为124例(43.0%),而单支血管病变和双支血管病变病例数一样,均为82例(28.5%)。单支血管病变中最多见的是前降支67例(81.7%),其次是右冠状动脉12例(14.6%),左回旋支较少见;(4)多因素logistic回归分析发现:性别、民族、游离甲状腺素、载脂蛋白A1和白蛋白水平是CSFP患者的独立危险因素。结论 (1)男性、少数民族、游离甲状腺素、载脂蛋白A1和白蛋白水平是CSFP的独立危险因素;(2)CSFP更常见于三支冠状动脉病变组,单支冠状动脉病变者更常见于左前降支。     

Access to Care: End-to-End Digital Response for COVID-19 Care Delivery

The coronavirus disease 2019 pandemic disrupted health care, requiring organizational leaders to act quickly to manage the health-related concerns of individuals and communities. The ability to offer a variety of digitally enabled telehealth services with 24/7 access to nurse practitioners and physician assistants allowed us to care for patients in their homes. It reduced the spread of the virus, protected our employees from further disease spread, and provided early interventions to those in need. The roles of nurse practitioner leaders, the enacted strategies, and patient outcomes demonstrate the impact of an innovative digital care delivery model on care across the continuum.     

慢阻肺急性加重期患者延迟就医与家庭动力学的相关性研究

目的研究慢阻肺急性加重期患者延迟就医与家庭动力学的相关性,希望能够为慢阻肺急性加重期患者拟定护理措施提供科学依据。方法选取2017年1月-2019年12月我院240例诊断为慢阻肺急性加重期的患者为研究对象。根据患者入院就医的时间进行分组,时间≥24h的延迟就医的患者为观察组,时间<24h的及时就医患者为对照组。结果两组患者在文化水平、家庭年收入、在职状态、医疗保险和婚姻状况和APACHEⅡ评分比较(P<0.05)。观察组患者疾病观念、个性化、系统逻辑和家庭氛围得分比对照组高(P<0.05)。Pearman的相关性分析结果显示:慢阻肺急性加重期患者延迟就医时间与各个层面分数以及家庭动力总分呈现负相关性(P<0.05)。应变量为延迟就医为应变量,患者的一般资料为自变量,经Logistic回归分析结果表明:延迟就医的影响因素为文化水平、家庭动力评分、职业状态、家庭收入、婚姻状况和APACHEⅡ评分。结论慢阻肺急性加重期患者家庭动力总分与疾病观念、个性化、系统逻辑和家庭氛围得分与延迟就医时间呈现负相关性,患者延迟就医的影响因素是家庭动力学评分。