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Considerations regarding safety with pulsed field ablation for atrial fibrillation 有关心房颤动脉冲场消融术安全性的考虑因素
IF 2.5 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-01 DOI: 10.1016/j.hroo.2024.08.002

The introduction of pulsed field ablation (PFA) in electrophysiology marks a significant advancement, promising efficacy comparable to thermal ablation methods while potentially providing safety advantages. Despite a generally favorable safety profile in human trials and postmarket registries, cautious evaluation of PFA's safety is essential. This review provides a comprehensive overview of key safety considerations as we discuss a myriad of considerations ranging from thermal effects, gaseous microbubble formation, muscle contractions, and proarrhythmia to procedural techniques. We explore specific safety concerns with phrenic nerve injury, cerebral lesions, coronary artery spasm, hemolysis and pulmonary bleeding. Vigilance in safety monitoring, coupled with advancements in procedural techniques and understanding of PFA's unique effects, is crucial for optimizing the safe and effective use of PFA.

脉冲场消融术(PFA)在电生理学领域的引入标志着一项重大进步,其疗效有望与热消融方法相媲美,同时还具有潜在的安全性优势。尽管人体试验和上市后登记的安全性总体良好,但谨慎评估 PFA 的安全性至关重要。本综述全面概述了主要的安全性考虑因素,我们讨论了从热效应、气态微泡形成、肌肉收缩、前心律失常到手术技术等一系列考虑因素。我们还探讨了膈神经损伤、脑损伤、冠状动脉痉挛、溶血和肺出血等具体的安全问题。对安全监控的警惕,加上手术技术的进步和对 PFA 独特作用的了解,对于优化 PFA 的安全有效使用至关重要。
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引用次数: 0
Outcomes of patients with malignancy undergoing catheter ablation for ventricular tachycardia in the United States 美国接受室性心动过速导管消融术的恶性肿瘤患者的治疗效果
IF 2.5 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-01 DOI: 10.1016/j.hroo.2024.07.011
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引用次数: 0
Risk factors and incidence of new-onset heart failure with conventional pacemaker implant: A nationwide study 常规起搏器植入后新发心力衰竭的风险因素和发病率--一项全国性研究
IF 2.5 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-01 DOI: 10.1016/j.hroo.2024.07.012

Background

Studies have shown that the risk of new-onset heart failure (HF) is higher postimplantation for patients receiving right ventricular pacing.

Objective

This study aimed to investigate incidence, risk factors, and implications for long-term prognosis of new-onset HF in patients after pacemaker implantation.

Methods

Patients without pre-existing HF who received a pacemaker in Sweden during the period of 2005 to 2020 were identified via the nationwide Pacemaker Registry. Data were crossmatched with the population registry and national disease registries. The primary outcome was new-onset HF within 5 years, and a risk score for this was developed and validated.

Results

In all, 65,579 patients met the inclusion criteria (10,351 single-chamber ventricular and 55,228 dual-chamber pacemakers). A total of 13,792 (21.0%) patients were diagnosed with HF within 5 years postimplantation. Of these, 6244 (45.3%) were hospitalized for HF. Patients with new-onset HF were more likely to die within 5 years (41.2% vs 19.7%, P < .0001). Risk factors for new-onset HF included increasing age, male sex, hypertension, diabetes, atrial fibrillation, chronic lung and kidney disease, ischemic heart disease, and atrioventricular block. In a combined score using these variables, patients in the highest risk-score quartile had a hazard ratio of 5.36 (95% CI 4.91–5.86, P < .001) and an absolute risk of 32% for developing HF.

Conclusion

Pacemaker therapy is associated with >20% risk of new-onset HF within 5 years, and we identified 9 risk factors associated with the diagnosis of new-onset HF. The proposed score based on these variables can be used to identify patients at high risk for new-onset HF.

背景研究表明,接受右心室起搏的患者在植入起搏器后新发心力衰竭(HF)的风险较高。方法通过全国起搏器登记处确定 2005 年至 2020 年期间在瑞典接受起搏器治疗的无 HF 患者。数据与人口登记和国家疾病登记进行交叉比对。结果共有65579名患者符合纳入标准(10351名单腔心室起搏器患者和55228名双腔起搏器患者)。共有 13,792 名患者(21.0%)在植入后 5 年内被诊断出患有心房颤动。其中 6244 人(45.3%)因心房颤动住院。新发心房颤动患者更有可能在 5 年内死亡(41.2% vs 19.7%,P < .0001)。新发 HF 的风险因素包括年龄增长、男性、高血压、糖尿病、心房颤动、慢性肺病和肾病、缺血性心脏病和房室传导阻滞。结论心脏起搏器治疗与 5 年内新发 HF 的>20%风险相关,我们发现了与新发 HF 诊断相关的 9 个风险因素。根据这些变量提出的评分标准可用于识别新发高血压的高危患者。
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引用次数: 0
Performance of off-the-shelf machine learning architectures and biases in low left ventricular ejection fraction detection 低左室射血分数检测中现成机器学习架构的性能和偏差
IF 2.5 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-01 DOI: 10.1016/j.hroo.2024.07.009

Background

Artificial intelligence–machine learning (AI-ML) has demonstrated the ability to extract clinically useful information from electrocardiograms (ECGs) not available using traditional interpretation methods. There exists an extensive body of AI-ML research in fields outside of cardiology including several open-source AI-ML architectures that can be translated to new problems in an “off-the-shelf” manner.

Objective

We sought to address the limited investigation of which if any of these off-the-shelf architectures could be useful in ECG analysis as well as how and when these AI-ML approaches fail.

Methods

We applied 6 off-the-shelf AI-ML architectures to detect low left ventricular ejection fraction (LVEF) in a cohort of ECGs from 24,868 patients. We assessed LVEF classification and explored patient characteristics associated with inaccurate (false positive or false negative) LVEF prediction.

Results

We found that all of these network architectures produced LVEF detection area under the receiver-operating characteristic curve values above 0.9 (averaged over 5 instances per network), with the ResNet 18 network performing the highest (average area under the receiver-operating characteristic curve of 0.917). We also observed that some patient-specific characteristics such as race, sex, and presence of several comorbidities were associated with lower LVEF prediction performance.

Conclusions

This demonstrates the ability of off-the-shelf AI-ML architectures to detect clinically useful information from ECGs with performance matching contemporary custom-build AI-ML architectures. We also highlighted the presence of possible biases in these AI-ML approaches in the context of patient characteristics. These findings should be considered in the pursuit of efficient and equitable deployment of AI-ML technologies moving forward.

背景人工智能-机器学习(AI-ML)已证明有能力从心电图(ECG)中提取传统解读方法无法获得的临床有用信息。在心脏病学以外的领域也有大量的人工智能-机器学习研究,包括几种开源的人工智能-机器学习架构,它们可以以 "现成 "的方式应用于新问题。方法 我们应用了 6 种现成的人工智能-ML 架构来检测 24,868 名患者心电图中左心室射血分数(LVEF)偏低的情况。结果我们发现,所有这些网络架构检测左心室射血分数的受体运行特征曲线下面积值都超过了 0.9(每个网络 5 个实例的平均值),其中 ResNet 18 网络的性能最高(受体运行特征曲线下的平均面积为 0.917)。我们还观察到,一些患者的特异性特征,如种族、性别和是否患有多种并发症,与较低的 LVEF 预测性能有关。结论 这证明了现成的人工智能-ML 架构有能力从心电图中检测出临床有用的信息,其性能与当代定制的人工智能-ML 架构相当。我们还强调了这些人工智能-ML方法在患者特征方面可能存在的偏差。在追求高效、公平地部署人工智能-ML 技术的过程中,我们应该考虑这些发现。
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引用次数: 0
Remarkably high and accelerating failure rate of a widely used implantable cardioverter-defibrillator lead: A large-scale manufacturer-independent multicenter study with long accurate follow-up 一种广泛使用的植入式心律转复除颤器引线的显著且加速的高故障率 一项长期精确随访的大规模制造商独立多中心研究
IF 2.5 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-01 DOI: 10.1016/j.hroo.2024.07.010

Background

A high annual failure rate of the Linox family defibrillator lead was reported in various small single-center studies. No independent multicenter long-term performance information exists for this lead.

Objective

Our aim was to assess the longevity of the Linox family leads and to evaluate clinical variables and adverse events associated with failure.

Methods

This 4-center study included adults >18 years of age who received Linox family leads for the prevention of sudden cardiac death. From November 2006 to November 2016, a total of 3993 high-voltage leads of the Linox family were implanted and followed up on.

Results

The absolute failure rate was 10.6% (dwell time to lead failure of 6.3 ± 3.4 years). Multivariate analysis confirmed younger age (for every 5 years younger than 65 years) (hazard ratio 1.09, 95% confidence interval 1.05–1.14, P < .001) and subclavian access (hazard ratio 1.46, 95% confidence interval 1.18–1.81, P < .001) as independent risk factors for lead failure. Patients frequently presented themselves with inappropriate shocks (20% in patients with lead failure) due to detection of nonphysiologic high-rate signals/noise.

Conclusion

This is the largest physician-driven multicenter study on the very long-term performance of Linox family leads. Our data report a remarkably high failure rate of these leads. Our findings have significant implications for the management of patients. Monitoring by remote care should be available for all active Linox family leads.

背景据各种小型单中心研究报告,Linox 系列除颤器导联线的年故障率很高。我们的目的是评估 Linox 系列导联的使用寿命,并评估与失效相关的临床变量和不良事件。方法这项 4 中心研究纳入了接受 Linox 系列导联用于预防心脏性猝死的 18 岁成人。结果 绝对失败率为 10.6%(导联失败的停留时间为 6.3 ± 3.4 年)。多变量分析证实,年龄较小(65 岁以下每 5 岁)(危险比 1.09,95% 置信区间 1.05-1.14,P < .001)和锁骨下通路(危险比 1.46,95% 置信区间 1.18-1.81,P < .001)是导联失效的独立危险因素。由于检测到非生理的高频率信号/噪声,患者经常出现不适当的电击(占导联失效患者的 20%)。我们的数据显示,这些导联的故障率非常高。我们的研究结果对患者的管理具有重要意义。所有使用中的 Linox 系列导联均应接受远程护理监测。
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引用次数: 0
A prospective, multicenter, randomized controlled trial comparing VDD-ICD with VVI-ICD in detecting subclinical atrial fibrillation in patients with ICDs: The Dx-AF trial 比较 VDD-ICD 和 VVI-ICD 检测 ICD 患者亚临床心房颤动的前瞻性多中心随机对照试验:Dx-AF 试验
IF 2.5 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-01 DOI: 10.1016/j.hroo.2024.07.014
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引用次数: 0
Left ventricular pacing through coronary sinus after tricuspid valve replacement: A case report and review of the literature 三尖瓣置换术后通过冠状窦进行左心室起搏:病例报告和文献综述
IF 2.5 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-01 DOI: 10.1016/j.hroo.2024.07.017

In patients with a mechanical tricuspid prosthetic valve, the transvenous position of a ventricular lead through the coronary sinus (CS) is a good alternative option to right ventricular or epicardial lead implantation. In cardiac resynchronization therapy, pacing the left ventricular lateral wall was considered the best site for the CS lead. However, for patients without a left bundle branch block, the best position of CS leads remains controversial. Here, we present a case of placing CS lead in the anterior interventricular vein. Measurements at implantation and 2 years’ follow-up reported low pacing thresholds with good sensing thresholds. The electrocardiograph showed narrow QRS complexes (120 ms) and follow-up echocardiography at 2 years presented left ventricular ejection fraction 58.9%.

对于装有机械三尖瓣人工瓣膜的患者,通过冠状窦(CS)经静脉植入心室导联是替代右心室或心外膜导联植入的最佳选择。在心脏再同步化治疗中,左心室侧壁起搏被认为是 CS 导联的最佳位置。然而,对于没有左束支传导阻滞的患者,CS 导联的最佳位置仍存在争议。在此,我们介绍一例将 CS 导联置于前室间静脉的病例。植入时和两年随访的测量结果显示起搏阈值较低,感应阈值良好。心电图显示窄 QRS 波群(120 毫秒),2 年的随访超声心动图显示左室射血分数为 58.9%。
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引用次数: 0
Monitoring for arrhythmia in transthyretin cardiac amyloidosis with noninvasive ambulatory patch devices 利用非侵入性流动贴片设备监测跨甲状腺素心脏淀粉样变性的心律失常
IF 2.5 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-01 DOI: 10.1016/j.hroo.2024.07.013

Background

Transthyretin cardiac amyloidosis (ATTR-CA) is associated with an increased incidence of arrhythmias. We hypothesized that 2-week noninvasive ambulatory cardiac rhythm monitoring of patients with ATTR-CA would detect high rates of atrial fibrillation/atrial flutter (AF/AFL) and nonsustained ventricular tachycardia (NSVT).

Objective

The study sought to characterize arrhythmia in patients with ATTR-CA on 2-week, noninvasive cardiac rhythm monitors.

Methods

A total of 38 patients with ATTR-CA who underwent 2-week remote external patch monitoring were included in this single-center retrospective study. An age-matched control group included 38 patients who underwent the same cardiac rhythm monitoring as part of neurological workup.

Results

Of the ATTR-CA cohort, 26.3% had AF/AFL and 81.6% had NSVT. ATTR-CA was associated with higher rates of AF/AFL and NSVT compared with the control group. At a median follow-up of 45 weeks, there was no association between the presence of AF/AFL or NSVT on remote monitor in the ATTR-CA group and a composite of adverse clinical outcome.

Conclusion

ATTR-CA was associated with an elevated rate of AF/AFL and an even higher rate of NSVT on noninvasive ambulatory monitors. While evidence regarding the management of arrhythmias, particularly NSVT/ventricular tachycardia, in ATTR-CA remains limited, 2-week noninvasive cardiac monitoring can be considered to aid in risk stratification for both atrial and ventricular arrhythmias.

背景胰凝乳蛋白心脏淀粉样变性(ATTR-CA)与心律失常发病率增加有关。我们假设,对 ATTR-CA 患者进行为期 2 周的非侵入性动态心律监测可检测出较高的心房颤动/心房扑动 (AF/AFL) 和非持续性室性心动过速 (NSVT)。方法这项单中心回顾性研究共纳入了 38 名接受为期 2 周的远程外部贴片监测的 ATTR-CA 患者。结果 在 ATTR-CA 患者中,26.3% 有房颤/AFL,81.6% 有 NSVT。与对照组相比,ATTR-CA 与更高的房颤/AFL 和非房颤相关。在中位随访 45 周时,ATTR-CA 组远程监护仪上出现的房颤/AFL 或 NSVT 与不良临床结局的综合结果之间没有关联。虽然有关 ATTR-CA 中心律失常(尤其是 NSVT/室性心动过速)管理的证据仍然有限,但可以考虑进行为期两周的无创心脏监测,以帮助对房性和室性心律失常进行风险分层。
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引用次数: 0
A model for the development of cardiac implantable electronic device services in countries lacking such services 在缺乏心脏植入电子设备服务的国家发展此类服务的模式
IF 2.5 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-01 DOI: 10.1016/j.hroo.2024.06.005
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引用次数: 0
Influence of time to ablation on outcomes among patients with atrial fibrillation with pre-existing heart failure 消融时间对原有心力衰竭的心房颤动患者预后的影响
IF 2.5 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-01 DOI: 10.1016/j.hroo.2024.07.016

Background

Atrial fibrillation (AF) and heart failure (HF) are cardiac disorders that often coexist.

Objective

This study aimed to investigate how time to ablation could influence the outcomes of AF patients with pre-existing HF.

Methods

Using the 2013 to 2022 Optum Clinformatics database, AF patients with pre-existing HF were classified into 2 groups: early ablation (ablation within 6 months of AF diagnosis) and late ablation (ablation in the 6- to 24-month period after AF diagnosis). Outcomes including AF-related hospitalization, electrical cardioversion, repeat ablation, antiarrhythmic drug (AAD) use, and AF recurrence (a composite outcome of the aforementioned events) were assessed in the postblanking 24-month period. Inverse probability of treatment weighted Poisson regression estimated risk ratio (RR) and 95% confidence interval (CI) for each outcome.

Results

Overall, 601 patients were identified (early ablation: 347; late ablation: 254). In 24 months, the weighted data suggested that patients in the early ablation cohort had significantly lower rate of composite outcome (49.32% vs 61.39%, P = .01), repeat ablation (8.56% vs 17.35%, P < .01), and AAD use (35.95% vs 47.92%, P = .01). Early ablation was associated with a 20%, 51%, and 25% lower risk of composite outcome (RR 0.80, 95% CI 0.69–0.94), repeat ablation (RR 0.49, 95% CI 0.31–0.79), and AAD use (RR 0.75, 95% CI 0.61–0.92), respectively. No significant difference in AF-related hospitalization and electrical cardioversion were observed.

Conclusion

AF patients with pre-existing HF undergoing ablation within 6 months of AF diagnosis have a lower risk of AF recurrence than those undergoing late ablation, which was evidenced by a lower rate of repeat ablation and AAD use.

背景心房颤动(AF)和心力衰竭(HF)是经常并存的心脏疾病。方法利用 2013 年至 2022 年 Optum Clinformatics 数据库,将原有 HF 的心房颤动患者分为两组:早期消融(心房颤动诊断后 6 个月内消融)和晚期消融(心房颤动诊断后 6 至 24 个月内消融)。结果包括房颤相关住院、心脏电复律、重复消融、抗心律失常药物 (AAD) 使用和房颤复发(上述事件的综合结果),在空白对照后 24 个月期间进行评估。治疗加权泊松回归的逆概率估计了每种结果的风险比 (RR) 和 95% 置信区间 (CI)。结果总计确定了 601 例患者(早期消融:347 例;晚期消融:254 例)。在 24 个月内,加权数据显示,早期消融组患者的综合结果率(49.32% vs 61.39%,P = .01)、重复消融率(8.56% vs 17.35%,P <.01)和 AAD 使用率(35.95% vs 47.92%,P = .01)显著较低。早期消融与复合结局风险降低 20%、51% 和 25%(RR 0.80,95% CI 0.69-0.94)、重复消融风险降低 0.49(RR 0.49,95% CI 0.31-0.79)和使用 AAD 风险降低 0.75(RR 0.61-0.92)相关。结论 在确诊房颤后 6 个月内接受消融术的原有心房颤动患者的房颤复发风险低于晚期消融术患者,这体现在重复消融术和使用 AAD 的比例较低。
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引用次数: 0
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Heart Rhythm O2
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