Devices

Devices
  • 文章类型: Journal Article
    背景:无环心动过速(ELT)是在使用心脏可植入电子设备(CIED)的患者中遇到的最常见的起搏器介导的心动过速(PMT)。尽管启用了各种预防算法,我们遇到了几个反复发作的病例,长,和症状ELT。
    方法:我们回顾性分析了2019年1月至2023年3月在印度东部单个中心的设备诊所进行的连续设备检查。
    结果:4520例器械检查中有20例确诊和持续ELT。虽然大部分是良性的,在两种情况下,ELT导致左心室(LV)收缩功能障碍患者的临床恶化。即使心室功能良好,ELT导致房室(AV)同步性不当,导致一例出现致残症状。ELT与窦性心动过速和房性心动过速(AT)的区别并不总是容易的。磁体应用肯定是有用的区分。在这项研究中引发ELT的情况是长时间的AV延迟,VIP(心室内在偏好)/MVP(心室管理起搏),心房非捕获,心房欠/过感,室性早搏(PVC)/对联,心房过早收缩(PAC)和心室心房(VA)传导较慢。心室后心房不应期(PVARP)的速率响应缩短也促进了其发生并阻碍了故障排除。当发生ELT时,尽管PVARP的PVC后扩展,降低心房的敏感性,在测量VA传导时间后切换到双极传感和手动设置更长的PVARP是有用的。在某些情况下,必须关闭“速率响应PVARP”以防止ELT。相反,PVARP过度扩张导致2例患者出现重复的非折返性心室心房同步性(RNRVAS).检查植入过程中的VA传导和随访过程中的无创程序刺激(NIPS)可用于检查ELT的趋势。
    结论:临床显著的ELT是罕见的,但在具有内置预防算法的设备中并不少见。手动调整通常对排除故障很有用。
    BACKGROUND: Endless loop tachycardia (ELT) is the commonest pacemaker mediated tachycardia (PMT) encountered among patients with cardiac implantable electronic devices (CIEDs). Despite being enabled with various preventive algorithms, we encountered several cases having recurrent, long, and symptomatic ELT.
    METHODS: We retrospectively analyzed consecutive device checkups at device clinic at a single center of eastern India between January 2019 to March 2023.
    RESULTS: There were 20 cases of confirmed and sustained ELT among 4520 device checks. Although mostly benign, in two cases ELT led to clinical worsening in patients having left ventricular (LV) systolic dysfunction. Even with good ventricular function, ELT resulted in improper atrioventricular (AV) synchrony leading to disabling symptom in one case. The differentiation of ELT from sinus tachycardia and atrial tachycardia (AT) was not always easy. Magnet application is certainly useful to differentiate. The situations that provoked ELT in this study were-long AV delays, VIP (ventricular intrinsic preferences)/MVP (managed ventricular pacing), atrial non-capture, atrial under/over sensing, premature ventricular contractions (PVCs)/couplets, premature atrial contractions (PAC) and slower ventriculo-atrial (VA) conduction. Rate responsive shortening of post-ventricular atrial refractory period (PVARP) also promoted its occurrence and hindered troubleshooting. When ELT occurred despite post-PVC extension of PVARP, lowering the atrial sensitivity, switching to bipolar sensing and manual setting of longer PVARP after measuring VA conduction time were useful. \"Rate responsive PVARP\" had to be turned off in a few cases to prevent ELT. On the contrary, an over aggressive prolongation of PVARP led to repetitive non-reentrant ventriculo-atrial synchrony (RNRVAS) in two cases. Checking VA conduction during implantation and noninvasive program stimulation (NIPS) during follow up were useful to check the tendency for ELT.
    CONCLUSIONS: Clinically significant ELT is rare but not uncommon among devices having in-built preventive algorithms. Manual adjustments are often useful to troubleshoot the same.
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  • 文章类型: Editorial
    在这篇社论中,我们总结了《心血管医学前沿》杂志的研究主题“心力衰竭和移植病例报告:2022”中浏览次数最多和下载次数最多的文章。
    In this editorial we summarize the most viewed and downloaded contributing articles to the Research Topic \"Case Reports in Heart Failure and Transplantation: 2022\" of the journal Frontiers in Cardiovascular Medicine.
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  • 文章类型: Case Reports
    Hybrid closed-loop (HCL) therapy is rarely studied in pregnancy. We present three cases of women with type 1 diabetes who used the Medtronic 670G HCL system for most or all of gestation.
    The Medtronic 670G system has a manual mode (no automated insulin delivery) and an auto mode (AM, HCL therapy). Women in this case series used AM off-label in gestation.
    Case 1 started HCL therapy in the second trimester, her sensor glucose time spent <3.9 and >10 mmol/L improved thereafter. Case 1 had average sensor glucose (ASG) levels of 6.4 ± 2.4 mmol/L in the first trimester, 7.0 ± 2.7 mmol/L in the second trimester before HCL use, 7.1 ± 2.1 mmol/L in the second trimester after HCL use, and 6.8 ± 1.9 mmol/L in the third trimester. Case 1 continued AM during operative delivery and post-partum. Cases 2 and 3 used HCL therapy throughout gestation but with inconsistent time in AM. When they increased time in AM their glycaemic indices improved. Case 2 had ASG of 9.5 ± 3.4, 8.6 ± 2.9, and 7.9 ± 2.5 mmol/L in the first through third trimesters, respectively. Case 3 had ASG of 11.1 ± 4.8 and 3.9 to 10 mmol/L in the first and second trimesters, respectively. Case 2 continued HCL therapy post-partum, Case 3 did not.
    CareLink® Clinical Software only reports the non-pregnant time in range. Nonetheless, this represents the first report of HCL therapy in pregnancy with a system approved by the Food and Drug Administration in non-pregnant populations.
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  • 文章类型: Journal Article
    BACKGROUND: Wide-necked intracranial aneurysms present unique treatment challenges in the setting of subarachnoid hemorrhage. New generations of endoluminal devices (stents) have expanded our ability to treat complex aneurysms. The PulseRider Aneurysm Neck Reconstruction Device (PulseRider [Cerenovus, Irvine, California, USA]) is new to the U.S. market after receiving Food and Drug Administration approval in June 2017. Official recommendation for use of the PulseRider is with dual antiplatelet therapy (DAPT). Its design has been hypothesized to carry a lower risk of thromboembolic complications in the circumstance that DAPT needs to be discontinued.
    METHODS: Between March and June 2018, we treated 4 cases of ruptured wide-necked basilar tip aneurysms at the University of Colorado Hospital, Aurora, Colorado, with PulseRider-assisted coil embolization. Imaging and chart reviews were performed retrospectively on each of these patients.
    RESULTS: All 4 aneurysms were successfully treated with PulseRider-assisted coil embolization. There were no periprocedural hemorrhages and no postprocedural reruptures. Two patients developed nonocclusive thrombi in the posterior cerebral arteries at the time of coiling, which was resolved with intra-arterial glycoprotein IIb/IIIa receptor antagonists. Two patients developed external ventricular drain-associated hemorrhages, only one of which developed after the administration of DAPT. All patients were eventually discharged to home.
    CONCLUSIONS: The PulseRider device represents a novel design for stent-assisted coil embolization. We report a small but promising series of its successful use in the acute treatment of wide-necked, ruptured basilar artery aneurysms. Additional experience is needed to determine if this device has a place in our armamentarium for treatment of ruptured aneurysms.
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  • 文章类型: Journal Article
    这项审查的目的是描述承诺的理由和主要根本原因,在临床发展过程中,单独使用和/或与其他技术结合使用的候选药物的研究。为了轻松理解,将参考SpinalonTM的情况,由左旋多巴/卡比多巴/丁螺环酮组成的新型固定剂量组合(FDC)产品。这种药物能够触发,在单次口服给药后几分钟内,截瘫动物的基本非自愿“反射”行走45分钟。一个月内的每日给药被证明会随着时间的推移而导致表现增加,对肌肉骨骼和心血管系统有健康益处。双盲,剂量递增,对45名脊髓损伤受试者进行的随机I/IIa期研究成功提供了最大耐受剂量(MTD)和疗效的初步证据.为了探索如何优化疗效,我们设计了一项包含150名受试者的IIb期研究,以比较不同条件下重复给药的效果(组).用电动跑步机测试,用于体重支撑的安全带,提出了经皮脊髓刺激器和/或外骨骼,因为:1)这些设备不太可能改变安全性,但2)合理预期它们会增加脊髓运动神经元的激活,反射式步行感应,和肌肉骨骼/心血管的好处。这种方法通常会让第三阶段的研究清楚地证明,以更少的科目和更低的成本,在优化的条件和设置中使用SpinalonTM对健康的长期益处。这种药物开发的创新策略可能有助于进一步描述作用机制以及患者的最佳使用条件。适应其他产品的发展,这种方法可以提高安全性,功效,下一代CNS药物的临床实用性和依从性。
    The aim of this review is to describe the rationale and main underlying reasons for undertaking, during clinical development, the study of drug candidates used separately and/or in combination with other technologies. To ease comprehension, reference will be made to the case of SpinalonTM, a new fixed-dose combination (FDC) product composed of levodopa/carbidopa/buspirone. This drug is capable of triggering, within minutes after a single administration orally, 45 minute- episodes of basic involuntary \'reflex\' walking in paraplegic animals. Daily administration during one month was shown to lead to increased performance over time, with health benefits onto musculoskeletal and cardiovascular systems. A double-blind, dose-escalation, randomized phase I/IIa study with 45 spinal cord-injured subjects successfully provided the maximal tolerated dose (MTD) and preliminary evidence of efficacy. As an attempt to explore how efficacy may be optimized, a phase IIb study with 150 subjects was designed to compare the effects of repeated administration in different conditions (arms). Tests with a motorized treadmill, a harness for body weight support, a transdermal spinal cord stimulator and/or an exoskeleton were proposed because: 1) these devices are unlikely to alter safety but, 2) they are reasonably expected to increase spinal locomotor neuron activation, reflex walking induction, and musculoskeletal/cardiovascular benefits. This approach would normally allow the phase III study to demonstrate clearly, with fewer subjects and at lower costs, long-term benefits on health of SpinalonTM used in optimized conditions and settings. This innovative strategy in drug development may contribute to further describe the mechanisms of action as well as optimized conditions of use for patients. Adapted to the development of other products, such an approach may enable greater safety, efficacy, clinical utility and compliance to be sought for next-generation CNS drugs.
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