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Trends in the 30-year span of noninfectious cardiovascular implantable electronic device complications in Olmsted County 奥姆斯特德县非感染性心血管植入式电子设备并发症 30 年的发展趋势
IF 1.9 Pub Date : 2024-03-01 DOI: 10.1016/j.hroo.2024.02.001
Gurukripa N. Kowlgi MBBS, MS , Vaibhav Vaidya MBBS , Ming-Yan Dai MD , Pragyat Futela MBBS , Rahul Mishra MBBS , David O. Hodge , Abhishek J. Deshmukh MBBS , Siva K. Mulpuru MD, MPH , Paul A. Friedman MD , Yong-Mei Cha MD

Background

Cardiac implantable electronic devices (CIEDs), such as permanent pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices, alleviate morbidity and mortality in various diseases. There is a paucity of real-world data on CIED complications and trends.

Objectives

We sought to describe trends in noninfectious CIED complications over the past 3 decades in Olmsted County.

Methods

The Rochester Epidemiology Project is a medical records linkage system comprising records of over 500,000 residents of Olmsted County from 1966 to present. CIED implantations between 1988 and 2018 were determined. Trends in noninfectious complications within 30 days of implantation were analyzed.

Results

A total of 157 (6.2%) of 2536 patients who received CIED experienced device complications. A total of 2.7% of the implants had major complications requiring intervention. Lead dislodgement was the most common (2.8%), followed by hematoma (1.7%). Complications went up from 1988 to 2005, and then showed a downtrend until 2018, driven by a decline in hematomas in the last decade (P < .01). Those with complications were more likely to have prosthetic valves. Obesity appeared to have a protective effect in a multivariate regression model. The mean Charlson comorbidity index has trended up over the 30 years.

Conclusion

Our study describes a real-world trend of CIED complications over 3 decades. Lead dislodgements and hematomas were the most common complications. Complications have declined over the last decade due to safer practices and a better understanding of anticoagulant management.

背景心脏植入式电子装置(CIED),如永久性心脏起搏器、植入式心律转复除颤器和心脏再同步治疗装置,可减轻各种疾病的发病率和死亡率。罗切斯特流行病学项目是一个医疗记录链接系统,包含 1966 年至今奥姆斯特德县 50 多万居民的记录。确定了 1988 年至 2018 年期间的 CIED 植入情况。结果 在 2536 名接受 CIED 的患者中,共有 157 人(6.2%)出现了设备并发症。共有2.7%的植入者出现了需要干预的重大并发症。最常见的是导线脱落(2.8%),其次是血肿(1.7%)。从1988年到2005年,并发症呈上升趋势,直到2018年,并发症呈下降趋势,其原因是血肿在过去十年中有所下降(P <.01)。出现并发症的患者更有可能使用人工瓣膜。在多变量回归模型中,肥胖似乎具有保护作用。我们的研究描述了30年来CIED并发症的真实世界趋势。引线脱落和血肿是最常见的并发症。由于采用了更安全的操作方法以及对抗凝剂管理有了更好的了解,过去十年来并发症有所减少。
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引用次数: 0
Ultrasound-guided explantation technique for implantable loop recorder in patients with high body mass index: a practical approach 高体重指数患者植入式环路记录器的超声引导爆破技术:实用方法
IF 1.9 Pub Date : 2024-03-01 DOI: 10.1016/j.hroo.2024.01.009
Chokanan Thaitirarot MBChB, MSc (oxon) , Shirley Sze MBBS, MD , Suzanne Armstrong MSc , Riyaz Somani MBChB, PhD
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引用次数: 0
What do national radiotherapy guidelines for patients with cardiac devices teach us? 针对心脏装置患者的国家放疗指南对我们有何启示?
IF 1.9 Pub Date : 2024-03-01 DOI: 10.1016/j.hroo.2024.01.008
Andrei Alexandru Mircea MD , Teodora Donisan MD , Steven Feigenberg MD , Michael G. Fradley MD

The incidence of cardiac implantable electronic device (CIED) malfunctions caused by radiotherapy (RT) is approximately 5%. Although individual national guidelines and expert consensus documents exist, the increased use of RT to treat various cancers points out the need for a standardized document to guide risk assessment and management of CIEDs during RT. We describe potential adverse RT-related events on CIEDs as well as the proposed mechanism of dysfunction. We review the main current guidelines and recommendations, emphasizing similarities and differences.

放疗(RT)导致心脏植入式电子装置(CIED)故障的发生率约为 5%。虽然目前已有个别国家的指南和专家共识文件,但由于越来越多地使用 RT 治疗各种癌症,因此需要一份标准化文件来指导 RT 期间 CIED 的风险评估和管理。我们介绍了CIED可能发生的与RT相关的不良事件以及功能障碍的拟议机制。我们回顾了当前的主要指南和建议,强调了它们之间的异同。
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引用次数: 0
Predictive utility of the impedance drop on AF recurrence using digital intraprocedural data linked to electronic health record data 使用与电子健康记录数据相连的数字化术中数据预测阻抗下降对房颤复发的影响。
IF 1.9 Pub Date : 2024-03-01 DOI: 10.1016/j.hroo.2024.01.006
Paul Coplan MBA, ScD , Amit Doshi MD, FHRS , Mingkai Peng PhD , Yariv Amos MSc , Mati Amit MSc , Don Yungher PhD , Rahul Khanna BPharm, MBA, PhD , Liat Tsoref PhD

Background

Local impedance drop in cardiac tissue during catheter ablation may be a valuable measure to guide atrial fibrillation (AF) ablation procedures for greater effectiveness.

Objective

The study sought to assess whether local impedance drop during catheter ablation to treat AF predicts 1-year AF recurrence and what threshold of impedance drop is most predictive.

Methods

We identified patients with AF undergoing catheter ablation in the Mercy healthcare system. We downloaded AF ablation procedural data recorded by the CARTO system from a cloud-based analytical tool (CARTONET) and linked them to individual patient electronic health records. Average impedance drops in anatomical region of right and left pulmonary veins were calculated. Effectiveness was measured by a composite outcome of repeat ablation, AF rehospitalization, direct current cardioversion, or initialization of a new antiarrhythmic drug post–blanking period. The association between impedance drop and 1-year AF recurrence was assessed by logistic regression adjusting for demographics, clinical, and ablation characteristics. Bootstrapping was used to determine the most predictive threshold for impedance drop based on the Youden index.

Results

Among 242 patients, 23.6% (n = 57) experienced 1-year AF recurrence. Patients in the lower third vs upper third of average impedance drop had a 5.9-fold (95% confidence interval [CI] 1.81–21.8) higher risk of recurrence (37.0% vs 12.5%). The threshold of 7.2 Ω (95% CI 5.75–7.7 Ω) impedance drop best predicted AF recurrence, with sensitivity of 0.73 and positive predictive value of 0.33. Patients with impedance drop ≤7.2 Ω had 3.5-fold (95% CI 1.39–9.50) higher risk of recurrence than patients with impedance drop >7.2 Ω, and there was no statistical difference in adverse events between the 2 groups of patients. Sensitivity analysis on right and left wide antral circumferential ablation impedance drop was consistent.

Conclusion

Average impedance drop is a strong predictor of clinical success in reducing AF recurrence but as a single criterion for predicting recurrence only reached 73% sensitivity and 33% positive predictive value.

背景导管消融过程中心脏组织的局部阻抗下降可能是指导心房颤动(房颤)消融手术以获得更大疗效的一项有价值的测量指标。我们从基于云的分析工具(CARTONET)中下载了 CARTO 系统记录的房颤消融程序数据,并将其与患者的个人电子健康记录相链接。计算了左右肺静脉解剖区域的平均阻抗下降。疗效以重复消融、房颤再住院、直流电心脏复律或空白期后开始使用新的抗心律失常药物的综合结果来衡量。阻抗下降与 1 年房颤复发之间的关系通过调整人口统计学、临床和消融特征的逻辑回归进行评估。结果在 242 例患者中,23.6%(n = 57)的患者 1 年后房颤复发。平均阻抗下降率下三分之一与上三分之一的患者复发风险高出 5.9 倍(95% 置信区间 [CI] 1.81-21.8)(37.0% vs 12.5%)。阻抗下降 7.2 Ω(95% 置信区间 5.75-7.7 Ω)的阈值最能预测房颤复发,灵敏度为 0.73,阳性预测值为 0.33。阻抗下降≤7.2 Ω的患者比阻抗下降>7.2 Ω的患者复发风险高3.5倍(95% CI 1.39-9.50),两组患者的不良事件没有统计学差异。结论平均阻抗下降是临床成功减少房颤复发的有力预测指标,但作为预测复发的单一标准,其敏感性和阳性预测值分别仅为 73% 和 33%。
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引用次数: 0
Mexican contributions to the electrophysiology field 墨西哥在电生理学领域的贡献
IF 1.9 Pub Date : 2024-03-01 DOI: 10.1016/j.hroo.2023.11.005
Pedro Iturralde-Torres MD , Alejandra Iturralde-Chavez MD
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引用次数: 0
Safety of Sports for Patients with Subcutaneous Implantable Cardioverter Defibrillator (SPORT S-ICD): study rationale and protocol 皮下植入式心律转复除颤器(SPORT S-ICD)患者的运动安全性:研究原理和方案
IF 1.9 Pub Date : 2024-03-01 DOI: 10.1016/j.hroo.2024.01.007
Ehud Chorin MD, PhD , Rachel Lampert MD , Nick R. Bijsterveld MD, PhD , Reinoud E. Knops MD, PhD , Arthur A.M. Wilde MD , Hein Heidbuchel MD, PhD, FEHRA, FESC , Andrew Krahn MD , Ilan Goldenberg MD , Raphael Rosso MD , Dana Viskin MD , Shir Frydman MD , Lior Lupu MD , Sami Viskin MD

Background

Recent studies suggest that participation in recreational and even competitive sports is generally safe for patients with implantable cardioverter-defibrillators (ICDs). However, these studies included only patients with implanted transvenous ICD (TV-ICD). Nowadays, subcutaneous ICD (S-ICD) is a safe and effective alternative and is increasingly implanted in younger ICD candidates. Data on the safety of sport participation for patients with implanted S-ICD systems is urgently needed.

Objectives

The goal of the study is to quantify the risks (or determine the safety) of sports participation for athletes with an S-ICD, which will guide shared decision making for athletes requiring an ICD and/or wishing to return to sports after implantation.

Methods

The SPORT S-ICD (Sports for Patients with Subcutaneous Implantable Cardioverter Defibrillator) study is an international, multicenter, prospective, noninterventional, observational study, designed specifically to collect data on the safety of sports participation among patients with implanted S-ICD systems who regularly engage in sports activities.

Results

A total of 450 patients will undergo baseline assessment including baseline characteristics, indication for S-ICD implantation, arrhythmic history, S-ICD data and programming, and data regarding sports activities. LATITUDE Home Monitoring information will be regularly transferred to the study coordinator for analysis.

Conclusion

The results of the study will aid in shaping clinical decision making, and if the tested hypothesis will be proven, it will allow the safe continuation of sports for patients with an implanted S-ICD

背景最近的研究表明,对于植入式心律转复除颤器(ICD)的患者来说,参加娱乐性甚至竞技性体育运动一般都是安全的。然而,这些研究只包括植入经静脉 ICD(TV-ICD)的患者。如今,皮下 ICD(S-ICD)是一种安全有效的替代方法,越来越多的年轻 ICD 候选者开始使用这种方法。本研究的目的是量化植入 S-ICD 的运动员参加体育运动的风险(或确定其安全性),从而为需要 ICD 和/或植入后希望重返赛场的运动员共同决策提供指导。方法 SPORT S-ICD(皮下植入式心律转复除颤器患者的体育运动)研究是一项国际性、多中心、前瞻性、非介入、观察性研究,旨在收集定期参加体育活动的植入 S-ICD 系统的患者参加体育运动的安全性数据。结果 共有 450 名患者将接受基线评估,包括基线特征、S-ICD 植入指征、心律失常病史、S-ICD 数据和编程以及体育活动相关数据。LATITUDE 家庭监测信息将定期传送给研究协调员进行分析。 结论这项研究的结果将有助于临床决策的制定,如果测试假设得到证实,将允许植入 S-ICD 的患者安全地继续进行体育运动。
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引用次数: 0
Reviewer Thanks 评论员感谢
IF 1.9 Pub Date : 2024-03-01 DOI: 10.1016/S2666-5018(24)00035-7
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引用次数: 0
Outcomes with guideline-directed medical therapy and cardiac implantable electronic device therapies for patients with heart failure with reduced ejection fraction 射血分数减低型心力衰竭患者接受指导性药物疗法和心脏植入式电子设备疗法的疗效
IF 1.9 Pub Date : 2024-03-01 DOI: 10.1016/j.hroo.2024.01.004
John L. Mignone MD, PhD , Kevin M. Alexander MD , Michael Dobbles MS , Kyle Eberst MBA , Gregg C. Fonarow MD , Kenneth A. Ellenbogen MD

Background

Limited real-world evidence exists for outcomes with contemporary guideline-directed medical therapy (GDMT) or GDMT with implantable cardioverter-defibrillator (ICD)/cardiac resynchronization therapy defibrillator (CRT-D) therapy for patients with heart failure with reduced ejection fraction (HFrEF) and left ventricular ejection fraction (LVEF) ≤35%.

Objective

The present study aimed to assess survival associated with GDMT or GDMT with ICD/CRT-D therapy.

Methods

This retrospective observational study included real-world de-identified data from January 1, 2016, to December 19, 2023, from 24 U.S. institutions per participating institutional agreements (egnite Database; egnite, Inc.). Patients with a diagnosis of HFrEF and an echocardiographic study documenting LVEF ≤35% were included for analysis.

Results

Of 43,591 patients with eligible index event of LVEF ≤35%, prescription history through ≥1 year preindex, and no ICD/CRT-D therapy preindex, mean ± standard deviation age at index was 71.2 ± 13.2 years; 14,805 (34.0%) patients were female. At 24 months, an estimated 99.1% (95% confidence interval [CI] 99.0%–99.2%), 89.9% (95% CI 89.7%–90.1%), 54.8% (95% CI 54.4%–55.2%), and 17.2% (95% CI 16.9%–17.5%), had ≥1, 2, 3, or all 4 GDMT classes prescribed, respectively; an estimated 15.7% (95% CI 15.3%–16.1%) had device placement. Of those without a device, by 24 months, an estimated 45.1% (95% CI 44.4%–45.7%) had a documented LVEF >35%. Counts of GDMT classes prescribed as well as ICD/CRT-D device therapy were associated with lower mortality risk in this population, even after adjustment for patient age, sex, and comorbidities.

Conclusion

Both GDMT classes prescribed and device therapy were independently associated with lower mortality risk, even in the presence of more GDMT options for this more contemporary population.

背景对于射血分数降低(HFrEF)且左室射血分数(LVEF)≤35%的心力衰竭患者,采用当代指南指导下的医疗疗法(GDMT)或GDMT联合植入式心律转复除颤器(ICD)/心脏再同步化治疗除颤器(CRT-D)疗法的疗效,现有的真实世界证据有限。本研究旨在评估与 GDMT 或 GDMT 配合 ICD/CRT-D 治疗相关的生存率。方法这项回顾性观察研究纳入了 2016 年 1 月 1 日至 2023 年 12 月 19 日期间的真实世界去身份化数据,这些数据来自 24 家美国机构,根据参与机构协议(egnite Database; egnite, Inc.)结果 在 43,591 例符合条件的 LVEF ≤35% 指数事件、指数前处方史≥1 年且指数前未接受 ICD/CRT-D 治疗的患者中,指数时的平均年龄(± 标准差)为 71.2 ± 13.2 岁;14,805 例(34.0%)患者为女性。24 个月时,估计分别有 99.1%(95% 置信区间 [CI] 99.0%-99.2%)、89.9%(95% CI 89.7%-90.1%)、54.8%(95% CI 54.4%-55.2%)和 17.2%(95% CI 16.9%-17.5%)的患者使用了≥1、2、3 或全部 4 种 GDMT 类药物;估计有 15.7%(95% CI 15.3%-16.1%)的患者植入了设备。在未安装设备的患者中,到 24 个月时,估计有 45.1%(95% CI 44.4%-45.7%)的患者记录的 LVEF 为 35%。即使在对患者年龄、性别和合并症进行调整后,处方的 GDMT 类别计数以及 ICD/CRT-D 装置治疗仍与该人群较低的死亡风险相关。
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引用次数: 0
Contributions of Israel to the field of clinical cardiac electrophysiology and implantable devices 以色列对临床心脏电生理学和植入式设备领域的贡献
IF 1.9 Pub Date : 2024-02-01 DOI: 10.1016/j.hroo.2023.11.006
Bernard Belhassen MD
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引用次数: 0
Assessment of patient characteristics influencing the complexity of leadless pacemaker implantation 影响无引线起搏器植入术复杂性的患者特征评估
IF 1.9 Pub Date : 2024-02-01 DOI: 10.1016/j.hroo.2023.12.004
Hiroshi Miyama MD, PhD, Yukihiro Himeno MD, Shuhei Yano MD, Shuhei Yamashita MD, Koki Yamaoka MD, Susumu Ibe MD, Otoya Sekine MD, Yoshinori Katsumata MD, PhD, Takahiko Nishiyama MD, PhD, Takehiro Kimura MD, PhD, FHRS, Seiji Takatsuki MD, PhD, FHRS, Masaki Ieda MD, PhD

Background

The complexity of leadless pacemaker (LP) implantation varies widely. However, the predictive factors determining this difficulty are poorly understood.

Objective

The purpose of this study was to evaluate the factors influencing LP implantation difficulty, specifically procedural time during right atrial (RA) and right ventricular (RV) manipulation, based on patient background, cardiac function, and anatomic characteristics.

Methods

Analysis included LP implantation cases between 2017 and 2023, excluding the initial 3 implants performed by each operator. The relevance of patient background, cardiac function, and anatomic features on procedural and fluoroscopy times was evaluated.

Results

Fifty-four patients (mean age 82.2 ± 10.0 years; 57.4% male) were included in the study. Median procedural and fluoroscopy time was 45.8 minutes and 16.0 minutes, respectively, with an average of 2.0 ± 1.4 device deployments. Univariate analysis showed associations between procedural time and older age, RA and RV diameter, and severity of tricuspid regurgitation (TR). After adjustment for physician and potential contributing factors, RV dilation (midventricular diameter ≥35 mm) and severe TR were identified as independent predictors of prolonged procedural time. Medical history exhibited no association with procedural time. Consistent results were observed in analyses using fluoroscopy time as the outcome.

Conclusion

RV dilation and severe TR were associated with prolonged procedural time for LP implantation. Anatomic features obtained from preprocedural echocardiography could provide valuable insights into both the safety and efficiency of LP implantation, thereby enhancing tailored treatment strategies for patients undergoing pacemaker implantation.

背景无导联起搏器(LP)植入术的复杂程度差异很大。本研究的目的是根据患者背景、心脏功能和解剖特征,评估影响 LP 植入难度的因素,特别是右心房(RA)和右心室(RV)操作过程中的手术时间。方法分析包括 2017 年至 2023 年间的 LP 植入病例,不包括每位操作者最初进行的 3 次植入。结果54名患者(平均年龄82.2±10.0岁;57.4%为男性)被纳入研究。手术时间和透视时间的中位数分别为 45.8 分钟和 16.0 分钟,平均部署 2.0 ± 1.4 个装置。单变量分析显示,手术时间与年龄、RA 和 RV 直径以及三尖瓣反流(TR)的严重程度有关。在对医生和潜在诱因进行调整后,发现RV扩张(心室中径≥35毫米)和严重TR是手术时间延长的独立预测因素。病史与手术时间无关。结论RV扩张和严重TR与LP植入术的手术时间延长有关。从术前超声心动图中获得的解剖特征可以为 LP 植入术的安全性和效率提供有价值的信息,从而为接受起搏器植入术的患者提供更有针对性的治疗策略。
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引用次数: 0
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Heart Rhythm O2
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