Implantable defibrillator

植入式除颤器
  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    背景:临床实践中皮下植入式心脏复律除颤器(S-ICD)的编程研究很少,作为SMARTPass滤波器的激活状态,这是为了减少不适当的冲击。
    目的:我们评估了随访期间的器械编程和连续S-ICD受者的心律失常发生率。
    方法:我们分析了来自17个意大利中心的670名S-ICD患者在远程网络上随访的数据,中位时间为31个月(第25-75百分位数:16-51)。增强的SMARTPass版本,2022年10月推出,预计将降低无意停用率。
    结果:在最新的远程数据传输中,条件区域截止中位数设置为210bpm(第25-75百分位数:200-220),冲击区截止值为250bpm(第25-75百分位数:240-250),586名(87%)患者启用了SMARTPass。随访期间,118例(18%)患者报告了194例自动停用事件。129例(19%)患者发生休克,在136例(20%)患者中记录到未经治疗的心律失常.当SMARTPass启用-0.12/患者年(95%CI:0.10-0.14)与0.20(95%CI:0.15-0.26)(p=0.002)时,电击率较低,未治疗的心律失常发生率为-0.12/患者年(95%CI:0.11-0.14)和0.23(95%CI:0.18-0.30)(p=.001).增强的SMARTPass版本与0.14(95%CI:0.12-0.16)(p<.001)的低停用率-0.04/患者年(95%CI:0.02-0.05)相关,治疗和未治疗的心律失常减少(发生率:0.40(95%CI:0.28-0.53)和0.40(95%CI:0.30-0.55),分别(p<.001))。
    结论:中心倾向于对设备进行编程,以检测心律失常的高心室率,以减少不适当的电击发生。SMARTPass激活与较低的检测和治疗心律失常率相关。增强的SMARTPass版本似乎与较低的去活率和治疗的心律失常的进一步减少有关。
    BACKGROUND: The programing of subcutaneous implantable cardioverter-defibrillators (S-ICD) in clinical practice has been little studied, as the activation status of the SMART Pass filter, which was implemented to reduce inappropriate shocks.
    OBJECTIVE: We assessed device programing during follow-up and the rate of detected arrhythmias in consecutive S-ICD recipients.
    METHODS: We analyzed data from 670 S-ICD patients followed on the remote network at 17 Italian centers for a median of 31 months (25th-75th percentile: 16-51). The enhanced SMART Pass version, introduced in October 2022, was expected to reduce the unintentional deactivation rate.
    RESULTS: At the latest remote data transmission, the median conditional zone cut-off was set to 210 bpm (25th-75th percentile: 200-220), the shock zone cutoff was 250 bpm (25th-75th percentile: 240-250), and the SMART Pass was enabled in 586 (87%) patients. During follow-up, 194 automatic deactivation events were reported in 118 (18%) patients. Shocks were delivered in 129 (19%) patients, and untreated arrhythmias were recorded in 136 (20%) patients. The rate of shocks was lower when SMART Pass was enabled -0.12/patient-year (95% CI: 0.10-0.14) versus 0.20 (95% CI: 0.15-0.26) (p = .002), as it was the rate of untreated arrhythmias -0.12/patient-year (95% CI: 0.11-0.14) versus 0.23 (95% CI: 0.18-0.30) (p = .001). The enhanced SMART Pass version was associated with a lower rate of deactivations -0.04/patient-year (95% CI: 0.02-0.05) versus 0.14 (95% CI: 0.12-0.16) (p < .001), and with a reduction in treated and untreated arrhythmias (Incidence rate ratios: 0.40 (95% CI: 0.28-0.53) and 0.40 (95% CI: 0.30-0.55), respectively (p < .001)).
    CONCLUSIONS: Centers tend to program devices to detect high ventricular rates for arrhythmia detection, to minimize inappropriate shock occurrences. SMART Pass activation is associated with lower rates of detected and treated arrhythmias. The enhanced SMART Pass version seems associated with a lower deactivation rate and with a further decrease in treated arrhythmias.
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  • 文章类型: Case Reports
    长QT综合征(LQTS)是一种常染色体显性遗传性心脏病,其特征是QT间期延长和猝死风险。该综合征有17种亚型与11种基因的遗传变异有关。第二常见的是2型,由KCNH2基因突变引起,它是钾通道的一部分,影响心室动作电位的最终复极化。该病例报告介绍了一名厄瓜多尔青少年患有先天性长QT综合征2型(OMIMID:613688),来自没有心脏病或心源性猝死背景的家庭。
    一个14岁的晕厥女孩,正常的超声心动图,不规则的心电图诊断为LQTS。此外,通过执行下一代测序,与LQTS2型相关的KCNH2基因p.(Ala614Val)(ClinVarID:VCV000029777.14)的致病变异,以及AKAP9p.(Arg1654GlyfsTer23)(rs779447911)中两个不确定意义的变异,和TTNp.(Arg34653Cys)(ClinVarID:VCV001475968.4)基因被鉴定。此外,血统分析表明,主要是美洲原住民的比例。
    根据基因组结果,患者被确定为具有高风险特征,植入式心律转复除颤器被选为最佳治疗选择,强调包括临床和基因组学方面的整体诊断的重要性。
    UNASSIGNED: Long QT syndrome (LQTS) is an autosomal dominant inherited cardiac condition characterized by a QT interval prolongation and risk of sudden death. There are 17 subtypes of this syndrome associated with genetic variants in 11 genes. The second most common is type 2, caused by a mutation in the KCNH2 gene, which is part of the potassium channel and influences the final repolarization of the ventricular action potential. This case report presents an Ecuadorian teen with congenital Long QT Syndrome type 2 (OMIM ID: 613688), from a family without cardiac diseases or sudden cardiac death backgrounds.
    UNASSIGNED: A 14-year-old girl with syncope, normal echocardiogram, and an irregular electrocardiogram was diagnosed with LQTS. Moreover, by performing Next-Generation Sequencing, a pathogenic variant in the KCNH2 gene p.(Ala614Val) (ClinVar ID: VCV000029777.14) associated with LQTS type 2, and two variants of uncertain significance in the AKAP9 p.(Arg1654GlyfsTer23) (rs779447911), and TTN p. (Arg34653Cys) (ClinVar ID: VCV001475968.4) genes were identified. Furthermore, ancestry analysis showed a mainly Native American proportion.
    UNASSIGNED: Based on the genomic results, the patient was identified to have a high-risk profile, and an implantable cardioverter defibrillator was selected as the best treatment option, highlighting the importance of including both the clinical and genomics aspects for an integral diagnosis.
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  • 文章类型: Systematic Review
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  • 文章类型: Case Reports
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  • 文章类型: Journal Article
    设备接受度是识别植入式心律转复除颤器(ICD)患者面临社会心理困扰和不良生活质量结局的关键因素。这项研究的目的是检查ICD患者样本中佛罗里达患者接受调查(FPAS)的内部结构(构造)和可靠性的有效性的证据,比较完整版本(FPAS-18项目)和缩写版本(FPAS-12项目)的心理测量指标。样本包括151名参与者(97名男性,平均年龄为55.7±14.1岁),他完成了针对巴西背景的FPAS工具的跨文化改编版本。通过两种不同的方法评估了两种版本的FPAS仪器的心理测量特性:•探索性和验证性因子分析:用于测试仪器的内部结构•Cronbach的Alpha和McDonald的Omega:用于确定仪器的可靠性FPAS-Br仪器的两个版本显示出内部结构有效性和可靠性的一致证据。然而,FPAS-Br12项目显示出更好的心理测量调整,通过对模型质量指标的分析证实。
    Device acceptance is a crucial factor in identifying implantable cardioverter defibrillator (ICD) patients at risk for psychosocial distress and unfavorable quality of life outcomes. The purpose of this study was to examine the evidence of the validity of internal structure (construct) and reliability of the Florida Patient Acceptance Survey (FPAS) in a sample of ICD patients, comparing the psychometric indicators of the complete (FPAS-18 item) and abbreviated (FPAS-12 item) versions. The sample included 151 participants (97 males, mean age of 55.7 ± 14.1 years) who completed the cross-culturally adapted version of the FPAS instrument for the Brazilian context. The psychometric properties of both versions of the FPAS instrument were evaluated by two distinct approaches:•Exploratory and confirmatory factor analysis: used to test the internal structure of the instrument•Cronbach\'s Alpha and McDonald\'s Omega: used to determine the reliability of the instrument The two versions of the FPAS-Br instrument showed consistent evidence of internal structure validity and reliability. However, the FPAS-Br 12-item showed a better psychometric adjustment, confirmed by the analysis of the quality indicators of the models.
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  • 文章类型: Editorial
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  • 文章类型: Journal Article
    背景:在2022年和2023年,Medtronic召回了植入式除颤器,因为它们可能会提供少于全能量的电击。2022问题截断了波形的第二阶段(SCP-T2),导致32J冲击,并通过可下载软件缓解;2023年故障截断了波形的第一阶段,由于玻璃馈通问题(GFT-T1)导致0-12J冲击,这可以通过编程B>AX冲击极性来避免。
    目的:1)评估FDAMAUDE数据库中GFT-T1和SCP-T2电击的后果;2)估计GFT-T1和SCP-T2的发生率。
    方法:我们分析了由Medtronic数据补充的MAUDE报告;排除了导线故障。SCP-T2和GFT-T1的发生率是使用美国卷对带有玻璃馈通的设备进行估算的。
    结果:132个装置提供了截短的电击:27个(20.5%)为GFT-T1;103个(78.0%)为SCP-T2;2个(1.5%)截短了两个阶段(两者-T1&2)。在54例VF患者中,21例(38.9%)未通过截断电击除颤:8例(38.1%)接受GFT-T1电击,12例(57.1%)接受了SCP-T2电击,1例同时接受了T1&2电击;2例患者无关联死亡;1例外部抢救;1例结果不详;其他患者通过随后的电击进行除颤或自发终止。大多数因室性心动过速而休克的患者(79.1%)均被转换,主要(94.1%)被SCP-T2电击。GFT-T1和SCP-T2的估计发生率为0.0078-0.0088%和0.1062-0.1110%。
    结论:GFT-T1和SCP-T2电击可能导致VF/VT无法终止,但可以预防。虽然这些截断冲击的发生率非常低,加强监视是必要的。
    BACKGROUND: In 2022 and 2023, Medtronic recalled implantable defibrillators because they may deliver less than full-energy shocks. The 2022 problem truncates the second phase of the waveform (SCP-T2), resulting in ∼32-J shocks, and is mitigated by downloadable software. The 2023 malfunction truncates the first phase of the waveform, resulting in 0- to 12-J shocks due to a glassed feedthrough problem (GFT-T1) that might be avoided by programming B>AX shock polarity.
    OBJECTIVE: The purpose of this study was to assess the consequences of GFT-T1 and SCP-T2 shocks in the Food and Drug Administration\'s Manufacturers and User Facility Device Experience (MAUDE) database and to estimate the incidences of GFT-T1 and SCP-T2.
    METHODS: We analyzed MAUDE reports supplemented by Medtronic data; lead failures were excluded. The incidences of SCP-T2 and GFT-T1 were estimated using USA volumes for devices with glassed feedthroughs.
    RESULTS: One hundred thirty-two devices delivered truncated shocks: 27 (20.5%) were GFT-T1; 103 (78.0%) were SCP-T2; and 2 (1.5%) truncated both phases (BOTH-T1&2). Of 54 ventricular fibrillation (VF) patients, 21 (38.9%) were not defibrillated by truncated shocks: 8 (38.1%) received GFT-T1 shocks, 12 (57.1%) received SCP-T2 shocks, and 1 received a BOTH-T1&2 shock; 2 patients suffered unrelated deaths; 1 was externally rescued; 1 outcome was unknown; the others were defibrillated by subsequent shocks or terminated spontaneously. The majority of patients (79.1%) shocked for ventricular tachycardia (VT) were converted, primarily (94.1%) by SCP-T2 shocks. Estimated incidences of GFT-T1 and SCP-T2 were 0.0078%-0.0088% and 0.1062%-0.1110%.
    CONCLUSIONS: GFT-T1 and SCP-T2 shocks can result in failure to terminate VF/VT, but they may be preventable. Although the incidences of these truncated shocks are very low, heightened surveillance is warranted.
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