Pulmonary vein isolation

肺静脉隔离
  • 文章类型: Journal Article
    背景:脉冲场消融(PFA)是一种新颖的,心肌选择性,非热消融模式用于目标心律失常。尽管在肺静脉应用PFA后立即观察到EGM信号迅速消失,这一发现是否导致足够的透壁性病变尚不清楚.
    目的:如果重复应用和导管-组织接触对PFA期间的病变形成有影响。
    方法:使用环形PFA导管以各种水平的接触力反复施加能量。使用台式植物马铃薯模型和跳动的心室心肌模型来评估重复应用的影响,接触力,和导管在连续性和病变深度上重新定位。在植物模型中,病变发展超过18小时,在猪模型中超过6小时。
    结果:发现病变的形成依赖于重复应用和接触。在猪的脑室,单个和多个堆叠的应用导致3.5±0.7mm和4.4±1.3mm的病变深度,分别(p=0.002)。此外,导管与组织的接触越大,在植物模型中,病变越连续,越深(1.0±0.9mm,无接触Vs。5.4±1.4mm,力30g;p=.0001)。
    结论:通过圆形导管递送的PFA显示,重复和导管接触均独立导致较深的病变形成。这些发现表明,有效PFA消融的终点与PFA生物物理学有关,而不仅仅是EGM衰减。
    BACKGROUND: Pulsed field ablation (PFA) is a novel, myocardial-selective, non-thermal ablation modality used to target cardiac arrhythmias. Although prompt EGM signal disappearance is observed immediately after PFA application in the pulmonary veins, whether this finding results in adequate transmural lesions is unknown.
    OBJECTIVE: If application repetition and catheter-tissue contact impact on lesion formation during PFA.
    METHODS: A circular loop PFA catheter was used to deliver repeated energy applications with various levels of contact-force. A benchtop vegetal potato model and a beating heart ventricular myocardial model were utilized to evaluate the impact of application repetition, contact force, and catheter repositioning on contiguity and lesion depth. Lesion development occurred over 18 hours in the vegetal model and over 6 hours in the porcine model.
    RESULTS: Lesion formation was found to be dependent on application repetition and contact. In porcine ventricles, single and multiple stacked applications led to a lesion depth of 3.5 ± 0.7 mm and 4.4 ± 1.3 mm, respectively (p =0.002). Furthermore, the greater the catheter-tissue contact, the more contiguous and deeper the lesions in the vegetal model (1.0±0.9 mm with no contact Vs. 5.4±1.4 mm with 30 g of force; p=.0001).
    CONCLUSIONS: PFA delivered via a circular catheter showed that both repetition and catheter contact led independently to deeper lesion formation. These findings indicate that endpoints for effective PFA ablation are more related to PFA biophysics than mere EGM attenuation.
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  • 文章类型: Journal Article
    背景:尽管房颤(AF)的治疗策略有所改善,相当比例的患者在消融术后仍有复发.本研究旨在提出一种基于Transformer的新算法,该算法利用体表心电图(ECG)信号和临床特征来预测房颤复发。
    方法:在2018年10月至2021年12月之间,纳入了在窦性心律期间接受了至少一个标准10秒表面心电图的房颤射频消融术的患者。基于Transformer和融合模块的端到端深度学习框架用于使用ECG和临床特征预测AF复发。使用接收器工作特征曲线下面积(AUROC)评估模型性能,灵敏度,特异性,准确性和F1分数。
    结果:总共920名患者(中位年龄61[IQR14]岁,66.3%的男性)被包括在内。经过24个月的中位随访,253例患者(27.5%)出现房颤复发。单个深度学习启用的ECG信号识别出AF复发,AUROC为0.769,灵敏度为75.5%,特异性为61.1%,F1评分为55.6%,总体准确率为65.2%。结合心电信号和临床特征,AUROC提高到0.899,灵敏度提高到81.1%,特异性为81.7%,F1得分达到71.7%,总体准确率为81.5%。
    结论:Transformer算法在预测房颤复发方面表现出优异的性能。结合心电图和临床特征可增强模型的性能,并有助于识别指征消融术后房颤复发风险较低的患者。
    BACKGROUND: Despite improvement in treatment strategies for atrial fibrillation (AF), a significant proportion of patients still experience recurrence after ablation. This study aims to propose a novel algorithm based on Transformer using surface electrocardiogram (ECG) signals and clinical features can predict AF recurrence.
    METHODS: Between October 2018 to December 2021, patients who underwent index radiofrequency ablation for AF with at least one standard 10-second surface ECG during sinus rhythm were enrolled. An end-to-end deep learning framework based on Transformer and a fusion module was used to predict AF recurrence using ECG and clinical features. Model performance was evaluated using areas under the receiver operating characteristic curve (AUROC), sensitivity, specificity, accuracy and F1-score.
    RESULTS: A total of 920 patients (median age 61 [IQR 14] years, 66.3% male) were included. After a median follow-up of 24 months, 253 patients (27.5%) experienced AF recurrence. A single deep learning enabled ECG signals identified AF recurrence with an AUROC of 0.769, sensitivity of 75.5%, specificity of 61.1%, F1 score of 55.6% and overall accuracy of 65.2%. Combining ECG signals and clinical features increased the AUROC to 0.899, sensitivity to 81.1%, specificity to 81.7%, F1 score to 71.7%, and overall accuracy to 81.5%.
    CONCLUSIONS: The Transformer algorithm demonstrated excellent performance in predicting AF recurrence. Integrating ECG and clinical features enhanced the models\' performance and may help identify patients at low risk for AF recurrence after index ablation.
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  • 文章类型: Journal Article
    目的:CABANA研究表明,65岁以下的房颤患者从射频导管消融(RFCA)手术中获益更多。这项研究的目的是调查左向右分流术的固有卵圆孔未闭(PFO)对年轻房颤患者RFCA手术的影响。
    方法:基于是否存在固有PFO,将房颤患者分为PFO组和非PFO组。还研究了临床随访。
    结果:共纳入285例房颤患者。42例患者经TEE检测到PFO。PFO组初始房颤发作的患者年龄比非PFO组年轻(58.3±8.9vs.62.3±9.6岁,P=0.012)。PFO组年龄<55岁的房颤患者多于非PFO组。对于9例出现房颤复发的PFO患者,其中5例年龄<65岁的患者出现左至右分流的大小减小。这些患者的LAD降低。在PeAF患者中,年龄<65岁的53/64例患者和年龄大于65岁的23/40例患者无房颤(82.8%vs.57.5%,分别为;P=0.005)。
    结论:与无PFO的AF相比,合并PFO的AF不影响成功。年轻患者有更好的PeAFRFCA结果。有左心房扩大和严重房颤负担的年轻患者的房颤,可能导致EF降低并使PFO易于检测。
    OBJECTIVE: The CABANA study shows that atrial fibrillation (AF) paitents younger than 65 years benefit more from the AF radiofrequency catheter ablation (RFCA) procedure. The aim of this study is to investigate the impact of inherent patent foramen ovale (PFO) with a Left-to-Right Shunt on the RFCA procedure in young AF patients.
    METHODS: Based on the presence or absence of inherent PFO, the AF patients were divided into the PFO groups and the non-PFO group. Clinical follow-up was also investigated.
    RESULTS: A total of 285 AF patients were enrolled. PFO was detected by TEE in 42 patients. The age of patients at initial AF onset was younger in the PFO group than in the non-PFO group (58.3 ± 8.9 vs. 62.3 ± 9.6 years, P = 0.012). There were more AF patients aged <55 years in the PFO group than in the non-PFO group. For the 9 AF patients with PFO who experienced AF recurrence and the left-to-right shunts decreased in size in 5 of the patients aged <65 years. The LAD decreased in those patients. In the PeAF patients, 53/64 patients aged <65 years and 23/40 patients aged older than 65 years were free of AF (82.8 % vs. 57.5 %, respectively; P = 0.005).
    CONCLUSIONS: Success is not affected when AF is combined PFO compared with AF without PFO. Young patients have better PeAF RFCA outcomes. AF in young patients with left atria enlargement and a serious AF burden, may lead to reduced EF and render PFO easy to detect.
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  • 文章类型: Journal Article
    目的:脉冲场消融(PFA)是一种新兴的非热消融方式,在心房颤动(AF)的导管消融中具有广阔的前景。然而,这些PFA试验几乎普遍只包括高加索人群,关于其对其他种族/种族的影响的数据很少。PLEASE-AF试验旨在研究多电极六线PFA导管治疗以亚洲/中国为主的药物难治性阵发性AF患者的12个月疗效和安全性。
    结果:患者通过在肺静脉口(1800V)和心房(2000V)传递不同的脉冲强度来进行肺静脉(PV)隔离(PVI)。急性成功定义为等待20分钟后,所有PV均无PV电位和入口/出口传导阻滞。3、6和12个月的随访包括12导联心电图和24hHolter检查。主要疗效终点是12个月无任何持续至少30s的房性心律失常。该队列包括来自12家医院的143名患者,由28名操作员治疗:年龄60.2±10.0岁,65.7%男性,亚洲/中国100%,左心房直径36.6±4.9mm。所有PV(565/565,100%)均成功分离。整个过程,导管驻留,PFA申请总数,总透视时间为123.5±38.8分钟,63.0±30.7min,169.7±34.6s,和27.3±10.1分钟,分别。143例患者中有124例(86.7%)观察到了主要终点。一名患者(0.7%)在术后1个月出现少量心包积液,不需要干预。
    结论:新型六通道PFA导管在阵发性房颤的亚洲/中国人群中表现出普遍的急性PVI,具有良好的安全性,并有望在12个月内避免复发性房性心律失常。
    背景:ClinicalTrials.gov标识符:NCT05114954。
    OBJECTIVE: Pulsed field ablation (PFA) is an emerging non-thermal ablative modality demonstrating considerable promise for catheter ablation of atrial fibrillation (AF). However, these PFA trials have almost universally included only Caucasian populations, with little data on its effect on other races/ethnicities. The PLEASE-AF trial sought to study the 12-month efficacy and the safety of a multi-electrode hexaspline PFA catheter in treating a predominantly Asian/Chinese population of patients with drug-refractory paroxysmal AF.
    RESULTS: Patients underwent pulmonary vein (PV) isolation (PVI) by delivering different pulse intensities at the PV ostium (1800 V) and atrium (2000 V). Acute success was defined as no PV potentials and entrance/exit conduction block of all PVs after a 20-min waiting period. Follow-up at 3, 6, and 12 months included 12-lead electrocardiogram and 24-h Holter examinations. The primary efficacy endpoint was 12-month freedom from any atrial arrhythmias lasting at least 30 s. The cohort included 143 patients from 12 hospitals treated by 28 operators: age 60.2 ± 10.0 years, 65.7% male, Asian/Chinese 100%, and left atrial diameter 36.6 ± 4.9 mm. All PVs (565/565, 100%) were successfully isolated. The total procedure, catheter dwell, total PFA application, and total fluoroscopy times were 123.5 ± 38.8 min, 63.0 ± 30.7 min, 169.7 ± 34.6 s, and 27.3 ± 10.1 min, respectively. The primary endpoint was observed in 124 of 143 patients (86.7%). One patient (0.7%) developed a small pericardial effusion 1-month post-procedure, not requiring intervention.
    CONCLUSIONS: The novel hexaspline PFA catheter demonstrated universal acute PVI with an excellent safety profile and promising 12-month freedom from recurrent atrial arrhythmias in an Asian/Chinese population with paroxysmal AF.
    BACKGROUND: ClinicalTrials.gov Identifier: NCT05114954.
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  • 文章类型: Journal Article
    射频导管消融(RFCA)已被证明对肥厚型心肌病(HCM)患者的持续性心房颤动(AF)的疗效较低。我们进行了这项研究,以评估非阻塞性HCM患者在RFCA期间对持续性AF(PsAF)的Marshall(VOM)乙醇辅助静脉输注的益处。
    这项多中心回顾性观察性研究包括102例接受RFCA加VOM乙醇输注(VOM-EI)(RFCA+VOM,n=56)或单独使用RFCA(RFCA,n=46)第一次。疗效终点为消隐期后无房颤或房性心动过速(AT)的存活。
    我们在92.9%(52/56)的患者中完成了VOM-EI。左肺静脉窦消融时间(RFCA+VOM:19.9±6.1minvs.RFCA:27.2±9.3分钟),二尖瓣峡部(MI)消融时间(RFCA+VOM:16.9±3.7minvs.RFCA:28.4±7.8分钟),冠状窦(CS)静脉消融率(RFCA+VOM:57.69%vs.RFCA:80.43%)较低,但MI阻滞的急性成功率(RFCAVOM:98.1%vs.RFCA:84.8%)高于RFCA组(均p<0.05)。经过12个月的随访,RFCA+VOM组84.6%的患者(44/52)无AF/AT存活,RFCA组中65.2%的患者(30/46)(p=0.03;比值比=2.93,95%CI:1.18-7.79).
    VOM-EI联合RFCA可降低HCM伴PsAF患者12个月时AF/AT的复发率。VOM-EI简化了左肺静脉窦和MI的消融,并增加了MI双向阻滞的成功率。
    UNASSIGNED: Radiofrequency catheter ablation (RFCA) has been shown to have low efficacy for the treatment of persistent atrial fibrillation (AF) in patients with hypertrophic cardiomyopathy (HCM). We conducted this study to evaluate the benefit of adjunctive vein of Marshall (VOM) ethanol infusion during RFCA for persistent AF (PsAF) in patients with non-obstructive HCM.
    UNASSIGNED: This multicenter retrospective observational study included 102 consecutive non-obstructive HCM patients with PsAF who underwent RFCA plus VOM ethanol infusion (VOM-EI) (RFCA + VOM, n = 56) or RFCA alone (RFCA, n = 46) for the first time. The efficacy endpoint was survival without AF or atrial tachycardia (AT) after the blanking period.
    UNASSIGNED: We completed the VOM-EI in 92.9% (52/56) patients. The left pulmonary vein antrum ablation time (RFCA + VOM: 19.9 ± 6.1 min vs. RFCA: 27.2 ± 9.3 min), mitral isthmus (MI) ablation time (RFCA + VOM: 16.9 ± 3.7 min vs. RFCA: 28.4 ± 7.8 min), and rate of coronary sinus (CS) vein ablation (RFCA + VOM: 57.69% vs. RFCA: 80.43%) were lower but the acute success rate of MI block (RFCA + VOM: 98.1% vs. RFCA: 84.8%) were higher in the RFCA + VOM group than those in the RFCA group (all p < 0.05). After twelve months follow-up, 84.6% of patients (44/52) survived without AF/AT in the RFCA + VOM group, compared to 65.2% of patients (30/46) in the RFCA group (p = 0.03; odds ratio = 2.93, 95% CI: 1.18-7.79).
    UNASSIGNED: VOM-EI combined with RFCA decreased the recurrence rate of AF/AT at 12 months in HCM patients with PsAF. VOM-EI simplified the ablation of the left pulmonary vein antrum and MI and increased the success rate of MI bidirectional block.
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  • 文章类型: Journal Article
    不可逆电穿孔脉冲场消融治疗心房颤动涉及组织特异性和非热能诱导的细胞坏死,这有助于避免并发症,比如肺静脉狭窄,心房侧支组织损伤,和广泛的心房结构损伤,经常遇到传统的热消融。在现有的临床试验中,脉冲场消融对阵发性和持续性心房颤动患者的肺静脉隔离具有良好的效果。脉冲场消融很容易,简单,而且速度快,可以减少医源性损伤。因此,脉冲场消融技术在心房颤动治疗中的应用前景广阔。值得注意的是,不同消融导管系统的脉冲场消融参数的调整会强烈影响坏死心肌的面积和深度,这极大地影响了房颤复发的可能性和消融后不良并发症的发生率。在本文中,我们审查机制,优势,在总结前人一系列研究成果的基础上,提出了脉冲场消融的局限性,为今后的研究提供了思路和方向。
    Pulsed field ablation with irreversible electroporation for the treatment of atrial fibrillation involves tissue-specific and non-thermal energy-induced cell necrosis, which helps avoid complications, such as pulmonary vein stenosis, atrial collateral tissue damage, and extensive atrial structural damage, often encountered with traditional thermal ablation. In existing clinical trials, pulsed field ablation has shown excellent effects on pulmonary vein isolation in patients with paroxysmal and persistent atrial fibrillation. Pulsed field ablation is easy, simple, and quick and can reduce iatrogenic injury. Therefore, the application of pulsed field ablation technology in the treatment of atrial fibrillation has a promising future. Notably, the adjustment of parameters in pulsed field ablation with different ablation catheter systems can strongly affect the area and depth of the necrotic myocardium, which greatly affects the likelihood of atrial fibrillation recurrence and incidence of adverse complications after ablation. In this paper, we review the mechanisms, advantages, and limitations of pulsed field ablation based on the results of a series of previous studies and provide ideas and directions for future research.
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  • 文章类型: Journal Article
    尽管肺静脉隔离(PVI)仍然是房颤(AF)消融的主流方式。左心房后壁(LAPW)可能有助于房颤作为心律失常基质的发展。在房颤患者中,除PVI外的额外左心房后壁隔离(LAPWI)的疗效仍不确定。本研究探讨了后壁隔离(PWI)对房颤患者临床结局的影响。
    PubMed,EMBASE,在CochraneLibrary数据库中搜索比较有和没有PWI的房颤结局的研究。疗效转归为所有房性心律失常(AA)复发,心房颤动(AF),和房扑(AFL)/房性心动过速(AT)。安全性结果主要集中在手术不良事件上。
    共16项研究(7项随机对照试验(RCT),3项前瞻性研究和6项回顾性分析)纳入3340例房颤患者(PWI组1550例患者和单独PVI组1790例患者)。12项研究包括持续性房颤患者,3项研究针对阵发性房颤患者,1项研究同时针对阵发性房颤和持续性房颤。平均随访时间为16.56个月。在房颤患者中,辅助PWI明显降低了所有房性心律失常的复发(风险比(RR)0.78[95%CI0.64-0.95],I2=79%,p=0.01)和房颤复发(RR0.68[95%CI0.53-0.88],I2=75%,p=0.004);同时,额外的PWI对AFL/AT的低复发率没有实质性影响(RR1.23[95%CI0.94-1.60],I2=49%,p=0.12)。结果似乎在单纯PVI和PWI+PVI之间手术并发症的发生率没有显著差异(RR1.19[95%CI0.80-1.79],I2=0%,p=0.39)。在亚组分析中,与单纯PVI相比,在持续性房颤组和冷冻球囊消融组中,辅助PWI的获益更为明显.值得注意的是,与仅PVI相比,射频消融辅助PWI可能导致复发性AFL/AT略有增加(RR1.56[95%CI1.02-2.39],I2=30%,p=0.04)。
    与单独的PVI相比,额外的PWI至PVI似乎与房颤和房性心律失常的复发减少相关,而手术并发症的发生率没有增加。尤其是持续性房颤患者。与射频消融相比,冷冻球囊消融似乎更适合PWI。需要更多的随机对照试验来验证这一结论。
    UNASSIGNED: Although pulmonary vein isolation (PVI) remains the mainstream way of atrial fibrillation (AF) ablation. The left atrial posterior wall (LAPW) may contributes to the development of AF as an arrhythmogenic substrate. The efficacy of additional left atrial posterior wall isolation (LAPWI) beyond PVI is in AF patients remains undefined. This study explored the influence of posterior wall isolation (PWI) on clinical outcomes in AF patients.
    UNASSIGNED: PubMed, EMBASE, and Cochrane Library databases were searched for studies comparing the outcomes of AF with and without PWI. The efficacy outcomes were recurrence of all atrial arrhythmia (AA), atrial fibrillation (AF), and atrial flutter (AFL)/atrial tachycardia (AT). The safety outcomes were mainly focused on procedural adverse events.
    UNASSIGNED: A total of 16 studies (7 randomized controlled trials (RCTs), 3 prospective studies and 6 retrospective analyses) with 3340 AF patients were enrolled (1550 patients in PVI with PWI group and 1790 in PVI alone group). 12 studies included persistent atrial fibrillation patients, 3 studies with paroxysmal AF patients and 1 study with paroxysmal AF and persistent AF concurrently. Mean follow-up period was 16.56 months. In AF patients, adjunctive PWI obviously reduced the recurrence of all atrial arrhythmias (risk ratio (RR) 0.78 [95% CI 0.64-0.95], I 2 = 79%, p = 0.01) and the recurrence of AF (RR 0.68 [95% CI 0.53-0.88], I 2 = 75%, p = 0.004); Meanwhile, additional PWI left no impact substantially on lower recurrence of AFL/AT (RR 1.23 [95% CI 0.94-1.60], I 2 = 49%, p = 0.12). The results seemed to be no significant differences in occurrence rate of procedural complications between the PVI only and PWI+PVI (RR 1.19 [95% CI 0.80-1.79], I 2 = 0%, p = 0.39). In subgroup analyses, the benefit of adjunctive PWI compared with PVI only was more distinct in persistent AF group and cryoballoon ablation group. Notably, adjunctive PWI with radiofrequency ablation may induce a slight increase of recurrent AFL/AT compared with PVI only (RR 1.56 [95% CI 1.02-2.39], I 2 = 30%, p = 0.04).
    UNASSIGNED: Compared with PVI alone, additional PWI to PVI appeared to be associated with decreased recurrence of AF and atrial arrhythmias without an increased occurrence of procedural complications, especially in persistent AF patients. Cryoballoon ablation seemed more suitable for PWI compared with radiofrequency ablation. More RCTs are needed to verify the conclusion.
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  • 文章类型: Journal Article
    背景:脉冲场消融(PFA)是一种新兴的非热消融方式,在心房颤动(AF)的导管消融中具有广阔的前景。然而,这些PFA试验几乎普遍只包括白种人,关于其对其他种族/种族的影响的数据很少。
    目的:PLEASE-AF试验旨在研究多电极六电极PFA导管治疗主要为亚洲/中国人群的药物难治性阵发性房颤患者的12个月疗效和安全性。
    方法:患者通过在肺静脉口(1800V)和心房(2000V)传递不同的脉冲强度来进行肺静脉(PV)隔离。急性成功定义为等待20分钟后,所有PV均无PV电位和入口/出口传导阻滞。3、6和12个月的随访包括12-ECG和24小时Holter检查。主要疗效终点为持续至少30秒的12个月无任何房性心律失常。
    结果:该队列包括来自12家医院的143名患者,由28名操作员治疗:年龄60.2±10.0岁,65.7%男性,亚洲/中国100%,左心房直径36.6±4.9mm。所有PV(565/565,100%)均成功分离。整个过程,导管驻留,PFA申请总数,透视总次数为123.5±38.8分钟,63.0±30.7分钟,169.7±34.6秒和27.3±10.1分钟,分别。143例患者中有124例(86.7%)观察到了主要终点。一名患者(0.7%)在术后1个月出现少量心包积液,不需要干预。
    结论:新型六通道PFA导管在阵发性房颤的亚洲/中国人群中表现出普遍的急性PVI,具有良好的安全性,并有望在12个月内避免复发性房性心律失常。
    背景:URL:https://www。clinicaltrials.gov;唯一标识符:NCT05114954。
    OBJECTIVE: Pulsed field ablation (PFA) is an emerging non-thermal ablative modality demonstrating considerable promise for catheter ablation of atrial fibrillation (AF). However, these PFA trials have almost universally included only Caucasian populations, with little data on its effect on other races/ethnicities. The PLEASE-AF trial sought to study the 12-month efficacy and the safety of a multi-electrode hexaspline PFA catheter in treating a predominantly Asian/Chinese population of patients with drug-refractory paroxysmal AF.
    RESULTS: Patients underwent pulmonary vein (PV) isolation (PVI) by delivering different pulse intensities at the PV ostium (1800 V) and atrium (2000 V). Acute success was defined as no PV potentials and entrance/exit conduction block of all PVs after a 20-min waiting period. Follow-up at 3, 6, and 12 months included 12-lead electrocardiogram and 24-h Holter examinations. The primary efficacy endpoint was 12-month freedom from any atrial arrhythmias lasting at least 30 s. The cohort included 143 patients from 12 hospitals treated by 28 operators: age 60.2 ± 10.0 years, 65.7% male, Asian/Chinese 100%, and left atrial diameter 36.6 ± 4.9 mm. All PVs (565/565, 100%) were successfully isolated. The total procedure, catheter dwell, total PFA application, and total fluoroscopy times were 123.5 ± 38.8 min, 63.0 ± 30.7 min, 169.7 ± 34.6 s, and 27.3 ± 10.1 min, respectively. The primary endpoint was observed in 124 of 143 patients (86.7%). One patient (0.7%) developed a small pericardial effusion 1-month post-procedure, not requiring intervention.
    CONCLUSIONS: The novel hexaspline PFA catheter demonstrated universal acute PVI with an excellent safety profile and promising 12-month freedom from recurrent atrial arrhythmias in an Asian/Chinese population with paroxysmal AF.
    BACKGROUND: ClinicalTrials.gov Identifier: NCT05114954.
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  • 文章类型: Journal Article
    背景:卵圆孔未闭(PFO)影响20-34%的成年人,并与中风和其他疾病有关。PFO相关中风的常规治疗是闭合手术。金属装置与一些不良事件有关。
    目的:我们的目的是研究在接受肺静脉隔离术(PVI)的房颤(AF)患者中使用冷冻消融术进行PFO封堵术的有效性和安全性。
    方法:我们将22例经冷冻消融术行PVI的PFO和AF患者分为两组:标准PVI+房间隔(AS)冷冻消融术组(第1组,n=11)和标准PVI组(第2组,n=11)。导丝通过PFO进入左心房,在手术过程中没有AS穿刺。通过冷冻消融进行标准PVI。将冷冻球囊缩回至右心房并在PVI后对AS充气。第1组患者冷冻消融120-150秒,而第2组患者接受假消融术.共同的主要终点是PFO闭合率和AF复发和卒中/短暂性脑缺血发作(TIA)事件的复合。
    结果:两组间手术相关不良事件无差异。两组在1年随访时都没有缺血性卒中报告。第1组6个月时PFO闭合率明显高于第2组[7(63.6%)vs.1(9.1%),P=0.002]。消融后房颤复发在3个月时两组具有可比性[3(27.3%)与1(9.1%),P=0.269],六个月(0vs.0),和十二个月[2(18.2%)与1(9.1%),随访P=0.534]。
    结论:冷冻消融术是一种安全有效的方法,可在接受PVI的房颤患者中通过一次手术关闭PFO。
    BACKGROUND: Patent foramen ovale (PFO) affects 20%-34% of adults and is associated with strokes and other disorders. The conventional treatment of PFO-related strokes is a closure procedure. The metal device is associated with some adverse events.
    OBJECTIVE: Our aim was to investigate the efficacy and safety of PFO closure using cryoablation without implantation in patients with atrial fibrillation (AF) who underwent pulmonary vein isolation (PVI).
    METHODS: We divided the 22 patients with both PFO and AF who underwent PVI via cryoablation into 2 groups: standard PVI + atrial septal (AS) cryoablation group (group 1, n = 11) and standard PVI group (group 2, n = 11). The guidewire accesses the left atrium through the PFO without AS puncture during the procedure. Standard PVI via cryoablation was performed. The cryoballoon was retracted to the right atrium and inflated against the AS post-PVI. Patients in group 1 had cryoablation for 120-150 seconds, whereas patients in group 2 received sham ablation. The co-primary end points were the PFO closure rate and a composite of AF recurrence and stroke/transient ischemic attack (TIA) events.
    RESULTS: There were no differences in procedure-related adverse events between the 2 groups. Neither group had an ischemic stroke report at 1-year follow-up. The PFO closure rate at 6 months in group 1 was significantly higher than that in group 2 (7 [63.6%] vs 1 [9.1%]; P = .002). AF recurrence post ablation was comparable in both groups at 3 months (3 [27.3%] vs 1 [9.1%]; P = .269), 6 months (0 vs 0), and 12 months (2 [18.2%%] vs 1 [9.1%]; P = .534) of follow-up.
    CONCLUSIONS: Cryoablation is a safe and effective approach to close PFO in patients with AF undergoing PVI in a single procedure.
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  • 文章类型: Journal Article
    背景:心房颤动(AF)的导管消融包括肺静脉隔离和可能的进一步基质消融是最常见的电生理程序。严重的并发症并不常见,但缺乏他们在全球大型队列中的详细评估。
    目的:本研究的目的是确定房颤消融术患者围手术期严重并发症的发生率,并对这些并发症的诊断评估和处理提供详细的描述。
    方法:从全球23个中心收集个体患者数据。对所有接受导管消融的患者收集的数据有限,我们为在围手术期随访期间出现严重并发症的患者收集了一系列扩展的数据点.发病率,预测因子,患者特征,管理细节,并对消融相关并发症患者的总体结局进行了调查.
    结果:数据来自23个参与中心,其中进行了33,879次手术(中位年龄63岁,30%的女性,71%的射频消融)。严重并发症的发生率(n=271)低(填塞6.8‰,中风0.97‰,心脏骤停0.41‰,食管瘘0.21‰,死亡0.21‰)。年龄,女性性别,扩张的左心房,程序持续时间,射频能量的使用与所有严重并发症的复合终点独立相关。在经历填塞的患者中,13%需要心脏手术。93%的并发症患者在中位住院时间为5天(Q1-Q3:3-7天)后直接出院。
    结论:这项大型全球合作研究强调,填塞,中风,心脏骤停,食管瘘,房颤消融术后死亡罕见。年纪大了,女性性别,程序持续时间,扩张的左心房,在这个跨国队列中,射频能量的使用与严重并发症相关.八分之一的填塞患者需要心脏手术。
    BACKGROUND: Catheter ablation for atrial fibrillation (AF) including pulmonary vein isolation and possibly further substrate ablation is the most common electrophysiological procedure. Severe complications are uncommon, but their detailed assessment in a large worldwide cohort is lacking.
    OBJECTIVE: The aim of this study was to determine the incidence of periprocedural severe complications and to provide a detailed characterization of the diagnostic evaluation and management of these complications in patients undergoing AF ablation.
    METHODS: Individual patient data were collected from 23 centers worldwide. Limited data were collected for all patients who underwent catheter ablation, and an expanded series of data points were collected for patients who experienced severe complications during periprocedural follow-up. Incidence, predictors, patient characteristics, management details, and overall outcomes of patients who experienced ablation-related complications were investigated.
    RESULTS: Data were collected from 23 participating centers at which 33,879 procedures were performed (median age 63 years, 30% women, 71% radiofrequency ablations). The incidence of severe complications (n = 271) was low (tamponade 6.8‰, stroke 0.97‰, cardiac arrest 0.41‰, esophageal fistula 0.21‰, and death 0.21‰). Age, female sex, a dilated left atrium, procedure duration, and the use of radiofrequency energy were independently associated with the composite endpoint of all severe complications. Among patients experiencing tamponade, 13% required cardiac surgery. Ninety-three percent of patients with complications were discharged directly home after a median length of stay of 5 days (Q1-Q3: 3-7 days).
    CONCLUSIONS: This large worldwide collaborative study highlighted that tamponade, stroke, cardiac arrest, esophageal fistula, and death are rare after AF ablation. Older age, female sex, procedure duration, a dilated left atrium, and the use of radiofrequency energy were associated with severe complications in this multinational cohort. One in 8 patients with tamponade required cardiac surgery.
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