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  • 文章类型: Editorial
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  • 文章类型: Journal Article
    心力衰竭(HF)继续影响全球人群,患病率不断增加。虽然HF的病理生理学非常复杂,自主神经系统的失调,就像交感神经活动增强一样,作为新疗法和HF的有吸引力的病理生理目标。已经发现神经激素激活的程度与症状的严重程度相关,功能能力下降,和死亡率。自主神经系统的神经调节旨在恢复交感神经系统和副交感神经系统之间的平衡。鉴于自主神经失调在HF的发展和进展中起主要作用,恢复这种平衡可能会对核心病理生理机制和各种HF综合征产生影响。自主调节已被提出作为旨在减少全身性炎症的潜在治疗策略。这种疗法,以药物和器械为基础的补充疗法可改善患者预后并降低疾病负担.目前,大多数专业协会都没有提供关于在HF中使用神经调节技术的明确建议。这些包括直接和间接的迷走神经刺激,脊髓刺激,压力反射激活疗法,颈动脉窦刺激,主动脉弓刺激,内脏神经调制,心肺神经刺激,去肾交感神经。在这次审查中,我们提供了HF神经调节的全面概述。
    Heart failure (HF) continues to impact the population globally with increasing prevalence. While the pathophysiology of HF is quite complex, the dysregulation of the autonomic nervous system, as evident in heightened sympathetic activity, serves as an attractive pathophysiological target for newer therapies and HF. The degree of neurohormonal activation has been found to correlate to the severity of symptoms, decline in functional capacity, and mortality. Neuromodulation of the autonomic nervous system aims to restore the balance between sympathetic nervous system and the parasympathetic nervous system. Given that autonomic dysregulation plays a major role in the development and progression of HF, restoring this balance may potentially have an impact on the core pathophysiological mechanisms and various HF syndromes. Autonomic modulation has been proposed as a potential therapeutic strategy aimed at reduction of systemic inflammation. Such therapies, complementary to drug and device-based therapies may lead to improved patient outcomes and reduce disease burden. Most professional societies currently do not provide a clear recommendation on the use of neuromodulation techniques in HF. These include direct and indirect vagal nerve stimulation, spinal cord stimulation, baroreflex activation therapy, carotid sinus stimulation, aortic arch stimulation, splanchnic nerve modulation, cardiopulmonary nerve stimulation, and renal sympathetic nerve denervation. In this review, we provide a comprehensive overview of neuromodulation in HF.
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  • 文章类型: Editorial
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  • 文章类型: Journal Article
    心房流量调节器(AFR;Occlutech)可用于在各种病理生理设置中创建具有预定直径的心房连通。在儿科人群中,经验仅限于少数病例报告。我们旨在报告先天性和后天性心脏病患儿AFR植入的初始单中心经验。
    从2021年12月到2023年6月,我们招募了10名患者(年龄6个月-16岁)。治疗适应症为:左心室收缩功能障碍(n=6),限制性心肌病伴肺动脉高压(n=2),一名12岁儿童(n=1)的原发性法洛四联症手术修复后右心室功能障碍,和失败Fontan(n=1)。所有患者均成功进行了AFR植入。8例需要进行房间隔穿刺;在其他2例中,使用先前存在的卵圆孔未闭和有孔的房间隔缺损。9例进行了球囊预扩张。在所有情况下植入8mm装置。手术的平均时间是50分钟,中位透视时间为17分钟,中位辐射暴露剂量为2.3Gy×cm2。
    术中无并发症报告。3例患者在随访期间死亡:1例由于败血症(手术后16天),1由于疾病进展(8个月后),1是由于心房通气后7天ECMO拔管失败。在剩下的病人中,LA扩张的减少,毛细血管后肺动脉高压,观察心力衰竭症状。
    AFR在儿童和危重环境中是安全可行的,允许右/左腔卸载和改善血流动力学和症状。
    UNASSIGNED: The Atrial Flow Regulator (AFR; Occlutech) can be used to create interatrial communication with a predetermined diameter in various pathophysiological settings. In the pediatric population, the experience is limited to a few case reports. We aim to report the initial single-center experience of AFR implantation in children with congenital and acquired heart disease.
    UNASSIGNED: From December 2021 to June 2023, we enrolled 10 patients (aged 6 months-16 years). Indications to treatment were: left ventricular systolic dysfunction (n = 6), restrictive cardiomyopathy with pulmonary hypertension (n = 2), postoperative right ventricle dysfunction after surgical repair of a native Tetralogy of Fallot in a 12-year-old child (n = 1), and failure Fontan (n = 1). AFR implantation was successfully performed in all patients. Transseptal puncture was needed in 8 cases; in the other 2 cases, preexisting patent foramen ovale and fenestrated atrial septal defect were used. Balloon predilation was performed in 9 cases. An 8 mm device was implanted in all cases. The mean time of the procedure was 50 minutes, the median fluoroscopy time was 17 minutes, and median radiation exposure dose was 2.3 Gy × cm2.
    UNASSIGNED: No complications were reported during the procedure. Three patients died during the follow-up: 1 due to sepsis (16 days after the procedure), 1 due to disease progression (8 months after), and 1 due to failure of ECMO decannulation 7 days after the atrial venting. In the remaining patients, a reduction of LA dilation, postcapillary pulmonary hypertension, and heart failure symptoms were observed.
    UNASSIGNED: AFR is safe and feasible in children and critical settings, allowing right/left cavities unloading and improvement of hemodynamics and symptoms.
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  • 文章类型: Journal Article
    将来自各种可穿戴设备的健康和活动数据集成到研究中,提出了技术和操作挑战。真棒数据采集方法(ADAM)是一种通用的,基于Web的系统,旨在集成来自各种来源的数据并管理大规模的多阶段研究研究。作为一个数据收集系统,ADAM允许通过设备的应用程序可编程接口和移动应用程序的自适应实时问卷从可穿戴设备收集实时数据。作为临床试验管理系统,ADAM集成了临床试验管理流程,并有效地支持招聘,筛选,随机化,数据跟踪,数据报告,和整个研究过程中的数据分析。我们使用行为减肥干预研究(SMARTER试验)作为测试案例来评估ADAM系统。SMARTER是一项随机对照试验,筛选了1741名参与者,招募了502名成年人。因此,ADAM系统被有效且成功地部署,以组织和管理SMARTER试验.此外,凭借其通用的集成能力,当COVID-19大流行停止面对面接触时,ADAM系统进行了必要的切换,以无缝,及时地进行完全远程评估和跟踪。ADAM系统提供的远程原生功能将COVID-19锁定对SMARTER试验的影响降至最低。SMARTER的成功证明了ADAM系统的全面性和高效性。此外,ADAM被设计为可推广和可扩展的,以适应其他研究,只需最少的编辑,再开发,和定制。ADAM系统可以使各种行为干预和不同人群受益。
    UNASSIGNED: The integration of health and activity data from various wearable devices into research studies presents technical and operational challenges. The Awesome Data Acquisition Method (ADAM) is a versatile, web-based system that was designed for integrating data from various sources and managing a large-scale multiphase research study. As a data collecting system, ADAM allows real-time data collection from wearable devices through the device\'s application programmable interface and the mobile app\'s adaptive real-time questionnaires. As a clinical trial management system, ADAM integrates clinical trial management processes and efficiently supports recruitment, screening, randomization, data tracking, data reporting, and data analysis during the entire research study process. We used a behavioral weight-loss intervention study (SMARTER trial) as a test case to evaluate the ADAM system. SMARTER was a randomized controlled trial that screened 1741 participants and enrolled 502 adults. As a result, the ADAM system was efficiently and successfully deployed to organize and manage the SMARTER trial. Moreover, with its versatile integration capability, the ADAM system made the necessary switch to fully remote assessments and tracking that are performed seamlessly and promptly when the COVID-19 pandemic ceased in-person contact. The remote-native features afforded by the ADAM system minimized the effects of the COVID-19 lockdown on the SMARTER trial. The success of SMARTER proved the comprehensiveness and efficiency of the ADAM system. Moreover, ADAM was designed to be generalizable and scalable to fit other studies with minimal editing, redevelopment, and customization. The ADAM system can benefit various behavioral interventions and different populations.
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  • 文章类型: Journal Article
    简介:开发可靠的治疗开放性骨折和不愈合导致的感染或潜在感染的骨丢失的方法是非常紧迫的,特别是减少受影响的患者所接受的长期抗菌治疗。多年来已经使用了许多骨移植替代品,但是目前没有有效的解决方案来治疗严重的骨质流失,尤其是在感染的情况下。本研究评估了生物形态磷酸钙骨支架b的使用。Bone™,基于下一代可吸收的仿生生物材料,在骨重建手术中感染的情况。方法:使用“体外3D骨折模型”来预测该药物递送系统在感染(或潜在感染)部位严重骨丢失期间的行为,评价了庆大霉素或万古霉素支架对人骨髓间充质干细胞(hMSCs)活力和分化能力的影响.结果:该支架,当装载庆大霉素或万古霉素时,表现出典型的药物释放曲线,确定对金黄色葡萄球菌生长的抑制作用,粪肠球菌,和大肠杆菌,以及相对生物膜的形成。讨论:研究表明,b.bone支架可以有效地解决骨科手术和患者护理中的关键挑战,通过快速抑制细菌生长和生物膜形成,有效的抗生素释放,降低因抵抗而导致治疗失败的风险,并为骨感染和改善患者预后提供有希望的解决方案。未来的研究可以探索这些支架上不同抗生素的组合,以针对创伤后骨髓炎病原体进行更量身定制和有效的治疗。
    Introduction: The development of reliable treatments for infected or potentially infected bone loss resulting from open fractures and non-unions is extremely urgent, especially to reduce the prolonged courses of antimicrobial therapy to which affected patients are subjected. Numerous bone graft substitutes have been used over the years, but there are currently no effective solutions to treat critical bone loss, especially in the presence of infection. The present study evaluated the use of the biomorphic calcium phosphate bone scaffold b. Bone™, based on a next-generation resorbable biomimetic biomaterial, in bone reconstruction surgery in cases of infection. Methods: Using an \"in vitro 3D bone fracture model\" to predict the behavior of this drug delivery system during critical bone loss at an infected (or potentially infected) site, the effects of scaffolds loaded with gentamicin or vancomycin on the viability and differentiation capacity of human mesenchymal stem cells (hMSCs) were evaluated. Results: This scaffold, when loaded with gentamicin or vancomycin, exhibits a typical drug release curve that determines the inhibitory effects on the growth of Staphylococcus aureus, Enterococcus faecalis, and Escherichia coli, as well as relative biofilm formation. Discussion: The study demonstrates that b.bone scaffolds can effectively address key challenges in orthopedic surgery and patient care by inhibiting bacterial growth and biofilm formation through rapid, potent antibiotic release, reducing the risk of treatment failure due to resistance, and providing a promising solution for bone infections and improved patient outcomes. Future studies could explore the combination of different antibiotics on these scaffolds for more tailored and effective treatments against post-traumatic osteomyelitis pathogens.
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  • 文章类型: Journal Article
    用户参与怀孕期间的远程血压监测对于优化血压控制和早期发现妊娠期高血压疾病的相关益处至关重要。在我们研究的怀孕人群中,我们发现连接的血压袖带,自动将措施同步到监控平台或健康记录,与需要手动输入测量的未连接袖带相比,使用远程血压监测增加参与度(每天2.13[95%CI1.36-3.35]倍)。
    UNASSIGNED: User engagement with remote blood pressure monitoring during pregnancy is critical to optimize the associated benefits of blood pressure control and early detection of hypertensive disorders of pregnancy. In our study population of pregnant individuals, we found that connected blood pressure cuffs, which automatically sync measures to a monitoring platform or health record, increase engagement (2.13 [95% CI 1.36-3.35] times more measures per day) with remote blood pressure monitoring compared to unconnected cuffs that require manual entry of measures.
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  • 文章类型: Journal Article
    背景:室间隔缺损(VSD)是最常见的先天性心脏畸形,约占先天性心脏缺陷的30%。使用体外循环的常规手术修复是侵入性的,并且与发病率和住院时间延长有关。随着介入方法的出现和不同闭塞装置的可用性,脑室封堵器技术正在不断发展,并在更大的患者群体中成功实施.我们在此介绍,我们对儿童室间隔缺损进行室间隔封堵的初步经验,以评估风险和获益.
    方法:从3月开始,2023年至2月,2024年,我们对13名儿童进行了室间隔缺损的室间隔封堵,在无体外循环支持的经食管超声心动图指导下。手术年龄中位数为2岁(范围1.3-10岁),体重中位数为11kg(范围8.7-16.6kg)。69%是男性。室间隔缺损大小为2.7至6mm(平均4.7mm)。七个缺陷是膜周,四个主动脉下和两个肌肉。一名患者还接受了肺动脉球囊血管成形术和其他一项动脉导管未闭结扎术的肺动脉去带术,同时。对于缺陷闭合,我们使用了室间隔缺损封堵器(MemoPart™,乐普医疗技术公司,中国)通过胸骨下部三分之一的3厘米皮肤切口。设备尺寸范围为5至8mm(平均6.9-1.8mm),所有患者均需要两个对称设备。
    结果:所有患者均成功进行封堵器闭合。手术持续时间在32到52分钟之间。没有患者需要体外循环。平均通气时间和重症监护病房住院时间为3和24小时,分别。没有患者需要正性肌力支持或输血。此外,没有患者出现任何心律失常,包括心脏传导阻滞.平均住院时间为4.4天。在最新的后续行动中,没有残留的分流器,传导干扰,任何患者出现装置移位或主动脉瓣或三尖瓣严重并发症。没有死亡。
    结论:室间隔缺损的室间隔装置闭合是一种较小的侵入性,在儿童非常安全和有效的方法。它与非常快的恢复有关,更短的住院时间和更好的美容切口。此外,它避免了体外循环。设计中的修改和完善,材料和植入技术将有助于扩大适应症并防止长期并发症。
    BACKGROUND: Ventricular septal defect (VSD) is the most common congenital cardiac malformation, accounting for approximately 30% of congenital heart defects. Conventional surgical repair using cardiopulmonary bypass is invasive and associated with morbidities and prolonged hospital stay. With the advent of interventional approaches and availability of different occluding devices, the technique of perventricular device closure is evolving and being implemented successfully in larger groups of patients. We present herein, our initial experience of perventricular device closure for the ventricular septal defects in children to assess risks and benefits.
    METHODS: From March, 2023 to February, 2024, we have performed perventricular closure of ventricular septal defects in 13 children, under guidance of transesophageal echocardiography without cardiopulmonary bypass support. The median age at operation was 2 year (range 1.3-10 years) with the median body weight 11 kg (range 8.7-16.6 kg). Sixty-nine percent were males. The ventricular septal defect sizes ranged from 2.7 to 6 mm (mean 4.7 mm). Seven defects were perimembranous, four sub-aortic and two were muscular. One patient also underwent pulmonary artery de-banding with pulmonary artery balloon angioplasty and other one patent ductus arteriosus ligation, concomitantly. For defect closure, we used ventricular septal defect occlusion device (MemoPart™, Lepu Medical Technology Company, China) through a 3-cm skin incision in the lower- third of the sternum. The device sizes ranged from 5 to 8 mm (mean 6.9+-1.8 mm) and all patients except for two required symmetrical devices.
    RESULTS: All patients underwent device closure successfully. The procedural duration ranged between 32 and 52 min. None of the patients required cardiopulmonary bypass. The mean ventilation time and intensive care unit stay was 3 and 24 h, respectively. None of the patients required inotropic support or blood transfusions. Moreover, no patients developed any arrhythmias including heart block. The average length of hospital stay was 4.4 days. At the latest follow up, there were no residual shunts, conduction disturbances, device dislodgement or major aortic or tricuspid valve complications seen in any patients. There was no mortality.
    CONCLUSIONS: Perventricular device closure of ventricular septal defects is a less invasive, extremely safe and effective method in children. It is associated with very fast recovery, shorter hospitalization time and better cosmetic incision. Moreover, it avoids cardiopulmonary bypass. The modifications and refinements in the design, material and implantation techniques will help in expanding the indications and prevent complications in the long-term.
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  • 文章类型: Journal Article
    目的:评估不涉及角膜压力应用的新型眼内压(IOP)测量原型仪器的准确性。
    方法:前瞻性病例对照研究。
    方法:一项机构研究,包括16名没有眼部病理的健康志愿者。使用新型原型和参考仪器(Goldmann压平眼压计(GAT)或iCare(iCare芬兰OY,万塔,芬兰))。在116对测量中比较了原型和参考仪器之间的IOP结果。
    结果:总体上,在提供的原型和参考仪器之间没有发现统计学上的显着差异。通过使用的仪器进行的分层测量显示,GAT没有显着差异,iCare的差异具有统计学意义(但在临床上不明显)。
    结论:所展示的原型证明眼压测量结果与参考仪器具有良好的临床一致性。有必要对青光眼患者进行大规模的评估。
    OBJECTIVE: To assess the accuracy of a prototype novel instrument for intra ocular pressure (IOP) measurements not involving corneal pressure application.
    METHODS: Prospective case control study.
    METHODS: An institutional study including 16 healthy volunteers without ocular pathology. IOP in both eyes of the participants was measured four times in different body positions with the novel prototype and reference instrument (Goldmann applanation tonometer (GAT) or iCare (iCare Finland OY, Vantaa, Finland)). IOP results were compared between the prototype and the reference instruments in 116 pairs of measurement.
    RESULTS: Overall no statistically significant difference was found between the presented prototype and the reference instrument. Stratifying measurements by instrument used revealed no significant difference for GAT and statistical significant (yet clinically insignificant) difference for iCare.
    CONCLUSIONS: The presented prototype demonstrates good clinical agreement of IOP measuring results with reference instruments Further large-scale studies assessing this instrument in glaucoma patients are warranted.
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  • 文章类型: Case Reports
    左心耳(LAA)血栓是左心耳封堵(LAAC)的禁忌症。然而,在选定的情况下,口服抗凝剂是严格禁忌的,因为有危及生命的出血史,和LAAC仍然是唯一可能的治疗,以避免全身性,尤其是脑栓塞。
    我们报告了一例LAAC病例,尽管有抗凝治疗绝对禁忌症的患者存在大量近端血栓,使用CT扫描进行全面的预先计划,设备建模和血栓捕获技术,以降低全身栓塞事件的风险并安全执行LAAC。
    尽管LAAC在这种情况下仍然处于高风险状态,使用谨慎的技术和工具,从术前计划到全身栓塞预防系统,这些系统与整个手术过程中精确的经食管超声心动图指导相关,允许在没有其他选项可用时尽可能安全地执行。
    UNASSIGNED: Left atrial appendage (LAA) thrombus is a contraindication for LAA closure (LAAC). However, in selected cases, oral anticoagulants are strictly contraindicated because of a history of life-threatening bleeding, and LAAC remains the only possible therapy to avoid systemic and especially cerebral embolization.
    UNASSIGNED: We report a case of LAAC despite a massive proximal thrombus in a patient who had an absolute contraindication to anticoagulant therapy, with thorough pre-planning using CT scan, device modelling and thrombus trapping techniques to reduce the risk of systemic embolic events and perform LAAC safely.
    UNASSIGNED: Although LAAC remains at high risk in this setting, the use of cautious techniques and tools, from pre-procedure planning to systemic embolization prevention systems associated to a precise transoesopheageal echocardiography guiding throughout the procedure, allows it to be performed as safely as possible when no other option is available.
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