novel technology

  • 文章类型: Journal Article
    脊柱畸形手术通常需要复杂的手术干预,这可能对患者的生活质量和功能能力产生巨大影响。这些畸形的现代矫正解决方案包括脊柱截骨术,椎弓根螺钉器械,和双/多杆结构。这些解决方案是有效的,目前被认为是脊柱外科医生的标准做法,但是他们缺乏个性化。患者专用棒(PSRs)是一项新技术,试图提供一种基于术前计算机断层扫描的个性化脊柱畸形矫正方法。此外,PSRs可以为传统棒提供几个优点,其中包括根据手术计划对齐目标实现所需的杆轮廓角度,减少手术时间,减少失血。在青少年特发性脊柱侧弯中,那些用PSR仪器观察到日冕Cobb减少高达74%。在成人脊柱畸形中,PSRs在X线摄影参数方面提供了出色的校正,例如矢状垂直轴和骨盆发生率减去腰椎前凸度。然而,这方面的研究仍然很少,主要是医疗保健支出,成本效益,和纵向临床结果。本文的目的是调查青少年和成人脊柱畸形人群中PSR仪器的最新知识。目前的实力,局限性,本文重点介绍了PSRs的未来发展方向。
    Spinal deformity surgery often requires complex surgical interventions that can have a drastic effect on both patient quality of life and functional capacity. Modern-day corrective solutions for these deformities include spinal osteotomies, pedicle screw instrumentation, and dual/multirod constructs. These solutions are efficacious and are currently considered standard practice for spinal surgeons, but they lack individualization. Patient-specific rods (PSRs) are a novel technology that attempts to offer a personalized approach to spinal deformity correction based on preoperative computerized tomography scans. Moreover, PSRs may offer several advantages to conventional rods, which include achievement of desired rod contour angles according to surgical planning alignment goals, reduced operative time, and reduced blood loss. In adolescent idiopathic scoliosis, those instrumented with PSR have observed coronal Cobb reductions up to 74%. In adult spinal deformity, PSRs have offered superior correction in radiographic parameters such as sagittal vertical axis and pelvic incidence minus lumbar lordosis. However, there still remains a paucity of research in this area, mainly in health care expenditure, cost-effectiveness, and longitudinal clinical outcomes. The purpose of this article is to survey the current body of knowledge of PSR instrumentation in both adolescent and adult spinal deformity populations. The current strength, limitations, and future directions of PSRs are highlighted throughout this article.
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  • 文章类型: Journal Article
    持续性心房颤动(AF)是包括心律失常的各种亚型和潜在原因的多种病症。近年来导管消融技术取得的进展显著提高了消融的耐久性。然而,尽管取得了这些进步,消融治疗持续性房颤的有效性仍相对较低.探索持续性房颤背后机制的研究已经确定了心房体内基质驱动的局灶性源和折返源对于持续性房颤个体的房颤维持至关重要。此外,心房晚期钆增强心脏磁共振(CMR)成像的广泛采用和侵入性电压标测技术的不断改进,使得在手术前或手术时可以对纤维化重塑进行详细评估.转化为临床实践,然而,结果总体令人失望。除了单独使用肺静脉隔离(PVI)外,房颤标测在消融手术中的临床应用并未显示出任何实质性优势,并且在最近的随机试验中,纤维化区域的辅助消融产生了矛盾的结果。脉冲场消融的出现代表了该领域的可喜发展,并且一些研究表明,这种非热能模式具有增强的安全性和提高的程序效率。脉冲场消融还有望实现肺静脉以外的安全有效的基质消融。但需要进一步的试验来评估其对长期成功率的影响.我们对房颤机制的理解不断进步,随着导管技术的持续发展,旨在安全形成透壁病变,对于持续性房颤患者实现更好的临床结局至关重要。
    Persistent atrial fibrillation (AF) is a diverse condition that includes various subtypes and underlying causes of arrhythmia. Progress made in catheter ablation technology in recent years has significantly enhanced the durability of ablation. Despite these advances however, the effectiveness of ablation in treating persistent AF is still relatively modest. Studies exploring the mechanisms behind persistent AF have identified substrate-driven focal and re-entrant sources within the atrial body as crucial in sustaining AF among individuals with persistent AF. Furthermore, the widespread adoption of atrial late gadolinium enhancement cardiac magnetic resonance (CMR) imaging and the ongoing refinement of invasive voltage mapping techniques have allowed for detailed assessment of fibrotic remodelling prior to or at the time of procedure. Translation into clinical practice, however, has yielded overall disappointing results. The clinical application of AF mapping in ablation procedures has not shown any substantial advantages beyond the use of pulmonary vein isolation (PVI) alone and adjunct ablation of fibrotic areas has yielded conflicting results in recent randomized trials. The emergence of pulsed field ablation represents a welcome development in the field and several studies have demonstrated an enhanced safety profile and increased procedural efficiency with this non-thermal energy modality. Pulsed field ablation also holds promise for safe and efficient substrate ablation beyond the pulmonary veins, but further trials are needed to assess its impact on longer term success rates. Continued advancements in our comprehension of AF mechanisms, alongside ongoing developments in catheter technology aimed at safe formation of transmural lesions, are essential for achieving better clinical outcomes for patients with persistent AF.
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  • 文章类型: Journal Article
    (1)背景与目的:二尖瓣反流是一种常见的瓣膜疾病,需要手术修复。即使结果令人满意,修复技术可能是主观性和可变性的基础,需要很长的学习曲线。一种新颖的方法,“罗马拱门”技术,可以减轻技术负担。这项研究评估了自动缝合装置的可行性和时间效率为提出的简化技术。(2)材料和方法:使用MiStitch™和MiKnot™设备(LSI解决方案,Inc.,维克多,NY,美国),缝合模式在尸体模型中进行.三名具有不同专业知识水平的外科医生进行了手术。记录并分析修复和缝合放置时间。(3)结果:在所有10个人类心脏标本上完成了改良的“罗马拱门”修复,平均总修复时间为3:01±00:59分钟,并且随着经验的增加,时间有减少的趋势。该研究证实了技术可行性,其中90%的尝试被评为相当令人满意或非常令人满意。(4)结论:MiStitch™系统有效地促进了离体环境中的改良“RomanArch”修复,提示其降低二尖瓣修复技术复杂性的潜力。需要进一步的研究来证实其在临床实践中的有效性和安全性。
    (1) Background and Objectives: Mitral regurgitation is a common valve disease requiring surgical repair. Even with satisfactory results, repair techniques may underlie subjectivity and variability and require long learning curves. A novel approach, the \"Roman Arch\" technique, may ease the technical burden. This study assessed an automated suturing device\'s feasibility and time efficiency for a proposed simplified technique. (2) Materials and Methods: Using the MiStitch™ and MiKnot™ devices (LSI Solutions, Inc., Victor, NY, USA), the suture pattern was performed in a cadaver model. Three surgeons with different expertise levels conducted the procedures. Repair and suture placement times were recorded and analyzed. (3) Results: The modified \"Roman Arch\" repair was completed on all ten human heart specimens with an average total repair time of 3:01 ± 00:59 min and a trend toward reduced times as experience increased. The study confirmed the technical feasibility with 90% of the attempts rated as rather satisfactory or very satisfactory. (4) Conclusions: The MiStitch™ system effectively facilitated the modified \"Roman Arch\" repair in an ex vivo setting, suggesting its potential to reduce the technical complexity of mitral valve repairs. Further studies are needed to confirm its efficacy and safety in clinical practice.
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  • 文章类型: Journal Article
    针对复发性或难治性造血肿瘤的靶向CD19和BCMA的CAR-T细胞疗法已在常规实践中被采用,并已显示出惊人的结果。然而,通过CAR-T疗法获得缓解的患者中,有一半最终会复发,因此,提高CAR-T疗法疗效的努力正在获得动力。值得注意的是,研究已经描述了创新技术,能够控制输注后的细胞动力学,这是传统CAR-T疗法所不可能的。在这篇文章中,我们回顾了CAR-T细胞治疗的挑战和新技术的发展。
    CAR-T cell therapy targeting CD19 and BCMA for relapsed or refractory hematopoietic tumors has been adopted in routine practice and has shown dramatic results. However, half of patients who achieve remission with CAR-T therapy eventually relapse, and thus efforts to improve the efficacy of CAR-T therapy are gaining momentum. Notably, studies have described innovative technologies that enable control of cell kinetics after infusion, which is not possible with conventional CAR-T therapies. In this article, we review the challenges of CAR-T cell therapy and the development of new technologies.
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  • 文章类型: Case Reports
    神经眼科医生通常会因可能的乳头水肿而接受转诊。出现水肿的视神经的一个常见原因是视盘玻璃疣(ODD)。我们描述了一部小说,手持,便携式超声设备,可用于在怀疑乳头水肿的情况下识别ODD。我们在这里证明了这种便携式超声系统可以在门诊眼科和神经病学环境中检测ODD。便携式版本展示了几个优点。该设备可以携带进入办公室,随时减少访问时间和办公空间。它比传统的超声波机器便宜得多。图像可以上传到安全服务器,并导入到患者的图表中。这些病例代表了这种新技术的一种潜在眼科应用,可以增强眼科检查并改善未来的患者护理。
    Neuro-ophthalmologists commonly receive referrals for possible papilloedema. One common cause of oedematous-appearing optic nerves is optic disc drusen (ODD). We describe a novel, handheld, portable ultrasound device that can be used to identify ODD in cases of suspected papilloedema. We demonstrate here that this portable ultrasound system can detect ODD in the outpatient ophthalmology and neurology settings. The portable version demonstrates several advantages. The device can be carried into the office, readily reducing visit times and office space. It is much more affordable than a traditional ultrasound machine. Images can be uploaded to a secure server and imported into the patient\'s chart. These cases represent one potential ophthalmological application of this novel technology that could augment the ophthalmological examination and improve patient care in the future.
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  • 文章类型: Journal Article
    高血压是世界范围内发病率和死亡率的主要原因。高血压大多没有症状,因此,血压(BP)测量是早期识别和及时治疗的唯一途径。BP测量方法有很长的发展和完善历史。通过动脉插管的侵入性方法在1800年代首次被证明是可能的。随后的科学进步导致了听诊方法的发展,也被称为Korotkoff的声音,和示波法,这使得临床上可用的BP测量成为可能。然而,高血压管理现状仍然较差。全球范围内,不到一半的成年人知道他们的高血压诊断,治疗中只有三分之一受到控制。由于传感器和机器学习等技术进步,以及临床对更简单,更方便的BP测量的需求,新方法得到了积极的研究。每种方法都采用不同的技术,具有自己的特定优点和缺点。新方法的承诺包括有关非办公室BP的综合信息,以捕获动态的短期和长期波动。然而,仍然存在缺陷,例如需要定期校准,因为大多数新颖的方法捕获相对BP变化而不是绝对值。此外,由于传统的验证方案不适用于无袖口连续方法,因此人们越来越关注其准确性和精密度。在这篇文章中,我们对BP测量方法的过去和现在进行了全面的概述。还介绍了新技术和新兴技术的潜在应用和局限性。
    Hypertension is the leading cause of morbidity and mortality worldwide. Hypertension mostly accompanies no symptoms, and therefore blood pressure (BP) measurement is the only way for early recognition and timely treatment. Methods for BP measurement have a long history of development and improvement. Invasive method via arterial cannulation was first proven possible in the 1800\'s. Subsequent scientific progress led to the development of the auscultatory method, also known as Korotkoff\' sound, and the oscillometric method, which enabled clinically available BP measurement. However, hypertension management status is still poor. Globally, less than half of adults are aware of their hypertension diagnosis, and only one-third of them being treated are under control. Novel methods are actively investigated thanks to technological advances such as sensors and machine learning in addition to the clinical needs for easier and more convenient BP measurement. Each method adopts different technologies with its own specific advantages and disadvantages. Promises of novel methods include comprehensive information on out-of-office BP capturing dynamic short-term and long-term fluctuations. However, there are still pitfalls such as the need for regular calibration since most novel methods capture relative BP changes rather than an absolute value. In addition, there is growing concern on their accuracy and precision as conventional validation protocols are inappropriate for cuffless continuous methods. In this article, we provide a comprehensive overview of the past and present of BP measurement methods. Novel and emerging technologies are also introduced with respect to their potential applications and limitations.
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  • 文章类型: Clinical Trial Protocol
    背景:利用低温热能的单次肺静脉隔离(PVI)是房颤(AF)患者的有效且安全的治疗方法。一种新颖的冷冻球囊系统,POLARx™,最近推出的。这项研究的目的是比较疗效,安全,和新型冷冻球囊系统之间的PVI的生物物理参数,POLARx™,和标准的冷冻球囊系统,北极前线前进Pro™(AFA-Pro),阵发性房颤患者。
    方法:CONTROST-CRYO试验是一项前瞻性试验,多中心,开放标签,在7个大型心脏中心进行的随机对照研究.本研究得到了每个参与医院的中央伦理委员会或当地伦理委员会的批准,并已在UMIN临床试验注册中心(UMIN000049948)注册。该试验将以1:1的比例将200名接受PVI的阵发性房颤患者分配给POLARx™和AFA-Pro。主要终点是右下肺静脉的一次性急性成功率。第二个终点包括免于记录的心房颤动,房扑,或在手术后12个月没有抗心律失常药物的房性心动过速,免于重做程序,手术相关不良事件的发生率,冻结持续时间,以及每个PV应用期间的生物物理参数,总程序和透视时间,和PVI耐久性在重做程序。
    结论:CONTROST-CRYO试验是一项前瞻性试验,多中心,旨在阐明疗效差异的随机研究,安全,在接受PVI的阵发性房颤患者中,POLARx™和AFA-Pro之间的生物物理参数。该试验的结果可能为选择最佳的冷冻球囊系统提供有价值的指示。
    背景:UMIN000049948.
    BACKGROUND: Single-shot pulmonary vein isolation (PVI) utilizing cryothermal energy is an effective and safe treatment for atrial fibrillation (AF) patients. A novel cryoballoon system, POLARx™, has been recently introduced. The aim of this study was to compare the efficacy, safety, and biophysical parameters of PVI between the novel cryoballoon system, POLARx™, and the standard cryoballoon system, Arctic Front Advance Pro™ (AFA-Pro), in patients with paroxysmal AF.
    METHODS: The CONTRAST-CRYO trial is a prospective, multicenter, open-label, randomized controlled study performed at seven large cardiac centers. This study was approved by the central ethics committee or the local ethics committee of each participating hospital and has been registered at UMIN Clinical Trials Registry (UMIN000049948). The trial will assign 200 patients with paroxysmal AF undergoing PVI to POLARx™ and AFA-Pro in a 1:1 randomization. The primary endpoint is the one-shot acute success rate of the right inferior pulmonary vein. Second endpoints include freedom from documented atrial fibrillation, atrial flutter, or atrial tachycardia without antiarrhythmic drugs at 12 months after the procedure, freedom from re-do procedures, the incidence of procedure-related adverse events, freezing duration, and the biophysical parameters during applications for each PV, total procedure and fluoroscopy time, and PVI durability during re-do procedures.
    CONCLUSIONS: The CONTRAST-CRYO trial is a prospective, multicenter, randomized study designed to elucidate the difference in the efficacy, safety, and biophysical parameters between POLARx™ and AFA-Pro in paroxysmal AF patients undergoing PVI. The findings from this trial may provide a valuable indication for selecting the optimal cryoballoon system.
    BACKGROUND:  UMIN000049948.
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  • 文章类型: Editorial
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  • 文章类型: Multicenter Study
    背景:肺静脉隔离(PVI)是心房颤动(AF)导管消融的基石。关于PolarX冷冻球囊的数据有限。
    目的:本研究旨在建立安全性,功效,低温球囊PVI当天放电的可行性。
    方法:跨12个中心的多中心研究。程序性度量,在一个足够大的队列中比较了PolarX冷冻球囊与ArticFrontAdvance(AFA)冷冻球囊的安全性和手术疗效,以提供明确的比较数据.
    结果:1688例患者接受PVI冷冻消融(50%PolarX和50%AFA)。成功的PVI与1677(99.3%)的患者和97.2%(n=1641)作为日间病例程序,并发症发生率<1%。安全,程序度量,PolarX冷冻球囊的疗效与AFA队列相当。PolarXCryobloon的最低点温度为54.6±7.6℃,30秒时的温度为38.6±7.2℃,达到-40℃的时间为34.1±13.7s,隔离时间(TTI)为49.8±33.2s。实现PVI的独立预测因素包括达到-40℃的时间(OR1.34;p<0.001)和最低点温度(OR1.24;p<0.001),最佳截止时间≤34秒(AUC0.73;p<0.001)和最低点温度分别为-≤54.0℃(AUC0.71)。
    结论:这项大规模的英国多中心研究表明,冷冻球囊PVI是一种安全有效的日间病例程序。使用PolarX冷冻球囊的PVI同样安全,作为AFA冷冻球囊有效。PolarX冷冻球囊获得的冷冻消融指标与AFA冷冻球囊报告的不同。使用PolarX冷冻球囊时,需要修改的冷冻消融目标。
    Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation for atrial fibrillation (AF). There are limited data on the PolarX Cryoballoon. The study aimed to establish the safety, efficacy, and feasibility of same day discharge for Cryoballoon PVI.
    Multi-centre study across 12 centres. Procedural metrics, safety profile, and procedural efficacy of the PolarX Cryoballoon with the Arctic Front Advance (AFA) Cryoballoon were compared in a cohort large enough to provide definitive comparative data. A total of 1688 patients underwent PVI with cryoablation (50% PolarX and 50% AFA). Successful PVI was achieved with 1677 (99.3%) patients with 97.2% (n = 1641) performed as day case procedures with a complication rate of <1%. Safety, procedural metrics, and efficacy of the PolarX Cryoballoon were comparable with the AFA cohort. The PolarX Cryoballoon demonstrated a nadir temperature of -54.6 ± 7.6°C, temperature at 30 s of -38.6 ± 7.2°C, time to -40°C of 34.1 ± 13.7 s, and time to isolation of 49.8 ± 33.2 s. Independent predictors for achieving PVI included time to reach -40°C [odds ratio (OR) 1.34; P < 0.001] and nadir temperature (OR 1.24; P < 0.001) with an optimal cut-off of ≤34 s [area under the curve (AUC) 0.73; P < 0.001] and nadir temperature of ≤-54.0°C (AUC 0.71; P < 0.001), respectively.
    This large-scale UK multi-centre study has shown that Cryoballoon PVI is a safe, effective day case procedure. PVI using the PolarX Cryoballoon was similarly safe and effective as the AFA Cryoballoon. The cryoablation metrics achieved with the PolarX Cryoballoon were different to that reported with the AFA Cryoballoon. Modified cryoablation targets are required when utilizing the PolarX Cryoballoon.
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  • 文章类型: Editorial
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