Implantable defibrillator

植入式除颤器
  • 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: Journal Article
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  • 文章类型: Meta-Analysis
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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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  • 文章类型: Journal Article
    背景:皮下植入式心脏复律除颤器(S-ICD)和无引线起搏器(LP)是需要ICD和起搏治疗的高感染风险患者的替代选择。在这个分析中,我们描述了高感染风险患者同时植入S-ICD和LP的情况.
    方法:研究队列包括因感染的高危因素而转诊到我们机构进行ICD植入的患者。
    结果:在2018年至2022年之间,有13名患者被转诊,包括11例感染ICD和2例存在高危因素的首次ICD植入。在感染ICD的情况下,成功的提取是使用机械扩张技术进行的。再植入被推迟到抗生素治疗的感染消退。这些装置是在一次手术中植入的,在LP放置后植入S-ICD,以通过体表ECG筛查验证感知是否足够。在所有患者中都确定了在抑制和心室起搏期间进行感知的合适向量。除颤测试是有效的,并且没有观察到重复计数或感知不足的问题。术后期间平安无事,在35个月的中位随访中,未报告并发症或感染.中位心室起搏百分比为5%,并报告了由于肌电位干扰引起的单个不适当的电击发作,并通过重新编程感应向量来解决。
    结论:对于需要ICD和起搏治疗的感染高危患者,同时植入S-ICD和LP是可行和安全的。这种组合方法为这些患者提供了有效的解决方案。
    BACKGROUND: The subcutaneous implantable cardioverter defibrillator (S-ICD) and leadless pacemaker (LP) are alternative options for patients at high risk of infection requiring ICD and pacing therapy. In this analysis, we described the simultaneous implantation of S-ICD and LP in patients with high infectious risk.
    METHODS: The study cohort comprised patients referred to our institution for ICD implantation due to high-risk factors of infection.
    RESULTS: Between 2018 and 2022, 13 patients were referred, including 11 with infected ICD and 2 for first ICD implantation in the presence of high-risk factors. In cases of infected ICD, successful extraction was performed using a mechanical dilatation technique. Reimplantation was delayed until resolution of infection with antibiotic therapy. The devices were implanted during a single procedure, with S-ICD implantation following LP placement for verification of sensing adequacy through surface ECG screening. Suitable vectors for sensing during inhibited and ventricular pacing were identified in all patients. Defibrillation testing was effective, and no issues with double counting or undersensing were observed. The postoperative period was uneventful, and during a median follow-up of 35 months, no complications or infections were reported. The median ventricular pacing percentage was 5%, and a single inappropriate shock episode due to myopotential interference was reported and resolved by reprogramming the sensing vector.
    CONCLUSIONS: Simultaneous implantation of S-ICD and LP is feasible and safe in patients at high risk of infection requiring both ICD and pacing therapy. This combined approach provides an effective solution for these patients.
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  • 文章类型: Observational Study
    背景:在心脏可植入电子设备(CIED)手术时,缺乏将维生素K拮抗剂(VKAs)与直接口服抗凝剂(DOAC)进行比较的数据。此外,DOAC的最佳管理(中断与延续)尚未确定。
    目的:本研究旨在根据抗凝剂类型(DOAC与VKA)和治疗方案(中断与不间断)比较器械相关出血和血栓事件的发生率。
    方法:这是一项观察性的多中心研究。我们纳入了接受慢性口服抗凝治疗的患者,这些患者正在接受CIED手术。使用倾向评分对患者进行匹配。
    结果:我们纳入了1,975名患者(年龄73.8±12.4岁)。在DOAC的1,326名患者中,78.2%(n=1039)的产前中断,21.8%(n=287)的中断继续。有649名患者继续进行VKA。匹配人群包括861名患者。与中断DOAC(1.7%)和持续VKA(2.1%)相比,持续DOAC(5.2%)的任何大出血率更高(P=0.03)。中断DOAC的围手术期血栓栓塞率为1.4%,而在DOAC或VKA继续治疗时没有发生血栓栓塞事件(P=0.04).使用双重抗血小板治疗,DOAC延续,在多变量分析中,男性是大出血的独立预测因子.
    结论:在这个庞大的现实世界中,在进行CIED手术的患者中,与DOAC中断或VKA延续相比,延续DOAC策略与更高的出血风险相关.然而,DOAC中断与血栓栓塞风险增加相关。临床上尽可能避免同时使用双重抗血小板治疗。定制的方法是必要的,最小DOAC中断的策略可能代表最好的妥协。
    BACKGROUND: There is a paucity of data comparing vitamin K antagonists (VKAs) to direct oral anticoagulants (DOACs) at the time of cardiac implantable electronic device (CIED) surgery. Furthermore, the best management of DOACs (interruption vs continuation) is yet to be determined.
    OBJECTIVE: This study aimed to compare the incidence of device-related bleeds and thrombotic events based on anticoagulant type (DOAC vs VKA) and regimen (interrupted vs uninterrupted).
    METHODS: This was an observational multicenter study. We included patients on chronic oral anticoagulation undergoing CIED surgery. Patients were matched using propensity scoring.
    RESULTS: We included 1,975 patients (age 73.8 ± 12.4 years). Among 1,326 patients on DOAC, this was interrupted presurgery in 78.2% (n = 1,039) and continued in 21.8% (n = 287). There were 649 patients on continued VKA. The matched population included 861 patients. The rate of any major bleeding was higher with continued DOAC (5.2%) compared to interrupted DOAC (1.7%) and continued VKA (2.1%) (P = 0.03). The rate of perioperative thromboembolism was 1.4% with interrupted DOAC, whereas no thromboembolic events occurred with DOAC or VKA continuation (P = 0.04). The use of dual antiplatelet therapy, DOAC continuation, and male sex were independent predictors of major bleeding on a multivariable analysis.
    CONCLUSIONS: In this large real-world cohort, a continued DOAC strategy was associated with a higher bleeding risk compared to DOAC interruption or VKA continuation in patients undergoing CIED surgery. However, DOAC interruption was associated with increased thromboembolic risk. Concomitant dual antiplatelet therapy should be avoided whenever clinically possible. A bespoke approach is necessary, with a strategy of minimal DOAC interruption likely to represent the best compromise.
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  • 文章类型: Journal Article
    目的:传统上涉及长期住院时间(LOS)的电生理(EP)手术现在作为日常病例程序进行。冠状病毒病(COVID)-19大流行推动了许多中心缩短EP程序的LOS。这项调查探讨了现代选修EP程序的LOS。
    结果:来自35个国家的245名受访者完成了一项由27个多项选择题组成的在线调查。关于新心脏可植入电子设备(CIED)的植入,79.5%的植入式环路记录仪报告了每日病例程序,13.3%的PM,植入式心脏复律除颤器(ICD)的10.4%和CRT设备的10.2%。关于TOCIED发电机更换,报告了61.7%的PM的日间病例程序,49.2%的ICD和48.2%的CRT设备。关于消融,据报道,5.7%的房颤(AF)消融的日间病例手术,左侧消融为10.7%,右侧消融为17.5%。据报道,47.7%的PM植入的LOS≥2天,54.5%的ICD和56.9%的CRT设备;54.5%的AF消融,右侧消融的42.2%和左侧消融的46.1%。据报道,报销(43-56%)和床位可用性(20-47%)对选修程序的组织没有一致的影响。
    结论:选择性EP程序的LOS差异很大。某些程序的LOS似乎与其复杂性不成比例。报销或床位可用性均未持续影响LOS。
    Electrophysiological (EP) operations that have traditionally involved long hospital lengths of stay (LOS) are now being undertaken as day case procedures. The coronavirus disease-19 pandemic served as an impetus for many centres to shorten LOS for EP procedures. This survey explores LOS for elective EP procedures in the modern era.
    An online survey consisting of 27 multiple-choice questions was completed by 245 respondents from 35 countries. With respect to de novo cardiac implantable electronic device (CIED) implantations, day case procedures were reported for 79.5% of implantable loop recorders, 13.3% of pacemakers (PMs), 10.4% of implantable cardioverter defibrillators (ICDs), and 10.2% of cardiac resynchronization therapy (CRT) devices. With respect to CIED generator replacements, day case procedures were reported for 61.7% of PMs, 49.2% of ICDs, and 48.2% of CRT devices. With regard to ablations, day case procedures were reported for 5.7% of atrial fibrillation (AF) ablations, 10.7% of left-sided ablations, and 17.5% of right-sided ablations. A LOS ≥ 2 days for CIED implantation was reported for 47.7% of PM, 54.5% of ICDs, and 56.9% of CRT devices and for 54.5% of AF ablations, 42.2% of right-sided ablations, and 46.1% of left-sided ablations. Reimbursement (43-56%) and bed availability (20-47%) were reported to have no consistent impact on the organization of elective procedures.
    There is a wide variation in the LOS for elective EP procedures. The LOS for some procedures appears disproportionate to their complexity. Neither reimbursement nor bed availability consistently influenced LOS.
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