Cryoballoon ablation

冷冻球囊消融
  • 文章类型: Journal Article
    UNASSIGNED: Cryoballoon ablation for pulmonary vein isolation is a time-efficient procedure that can alleviate stress on electrophysiology lab resources. This analysis modeled the impact of cryoballoon ablation on electrophysiology lab operation using data from Latin America.
    UNASSIGNED: Data from centers in Argentina, Mexico, Colombia, and Chile of the were used as inputs for an electrophysiology lab efficiency simulation model. The model used the assumption that either two (today\'s electrophysiology lab operations) or three (including electrophysiology lab operational changes) cryoballoon ablation procedures could be performed per day. The endpoints were the percentage of days that resulted in 1) overtime and 2) time left for an extra non-ablation electrophysiology procedure.
    UNASSIGNED: Data from a total of 232 procedures from six Latin American centers were included in the analysis. The average electrophysiology lab occupancy time for all procedures in Latin America was 132 ± 62 minutes. In the Current Scenario (two procedures per day), 7.4% of simulated days resulted in overtime, and 81.4% had enough time for an extra electrophysiology procedure. In the Enhanced Productivity Scenario (three procedures per day), 16.4% of days used overtime, while 67.4% allowed time for an extra non-ablation electrophysiology procedure.
    UNASSIGNED: Using real-world, Latin American-specific data, we found that with operational changes, three ablation procedures could feasibly be performed daily, leaving time for an extra electrophysiology procedure on more than half of days. Thus, use of cryoballoon ablation is an effective tool to enhance electrophysiology lab efficiency in resource-constrained regions such as Latin America.
    UNASSIGNED: La ablación con criobalón para el aislamiento de venas pulmonares es un procedimiento que ahorra tiempo y puede ahorrar recursos del laboratorio de electrofisiología. Este análisis modeló el impacto de la ablación con criobalón en el funcionamiento del laboratorio de electrofisiología utilizando datos de América Latina.
    UNASSIGNED: Los datos de los centros de Argentina, México, Colombia y Chile del se utilizaron como datos de entrada para un modelo de simulación de la eficiencia del laboratorio de electrofisiología. El modelo partió del supuesto de que se podían realizar dos (operaciones actuales del laboratorio de electrofisiología) o tres (incluidos los cambios operativos del laboratorio de electrofisiología) procedimientos de ablación con criobalón por día. Los criterios de valoración eran el porcentaje de días en los que se producían 1) horas extraordinarias y 2) tiempo restante para un procedimiento electrofisiológico adicional no relacionado con la ablación.
    UNASSIGNED: Se incluyeron en el análisis los datos un total de 232 procedimientos de seis centros latinoamericanos. El tiempo medio de ocupación del laboratorio de electrofisiología para todos los procedimientos en Latinoamérica fue de 132 ± 62 minutos. En el escenario actual (dos procedimientos por día), el 7,4% de los días simulados resultaron en horas extras, y el 81,4% tuvo tiempo suficiente para un procedimiento de electrofisiología adicional. En el escenario de productividad mejorada (tres procedimientos por día), el 16,4% de los días utilizó horas extraordinarias, mientras que el 67,4% dispuso de tiempo suficiente para un procedimiento electrofisiológico extra sin ablación.
    UNASSIGNED: Utilizando datos del mundo real específicos de América Latina, descubrimos que, aplicando cambios operativos, es factible realizar tres procedimientos de ablación al día, lo que deja tiempo para un procedimiento de electrofisiología adicional en más de la mitad de los días. Por lo tanto, el uso de la ablación con criobalón es una herramienta eficaz para mejorar la eficiencia de los laboratorios de electrofisiología en regiones con recursos limitados como América Latina.
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  • 文章类型: Journal Article
    背景:目前还没有关于冷却特性和变异肺静脉(PV)解剖结构对POLARx冷冻球囊(CB)消融后房颤(AF)复发的影响的报道。
    目的:分析肺静脉解剖变异和冷却特性的影响,多中心,预期登记处。
    方法:主要终点定义为1年无任何房性快速性心律失常(ATAs:AF/房扑-心动过速)。评估了ATAs复发与解剖变异/冷却特征之间的相关性。次要结果是主要的围手术期并发症的发生率。
    结果:429例连续诊断为阵发性房颤(83.4%)或持续性房颤(PEAF,16.6%)参加。28例(6.6%)患者表现出解剖变异(常见口=4.0%,辅助PV=2.6%)。最低点温度,标准PV和PV变体之间的解冻时间和总放气时间不同。在消隐周期之后,在平均431±99天的随访中,63例患者(14.7%)出现ATAs复发。复发患者的解冻时间较短(18.5±7svs19.8±7s,p=0.0012)和总放气时间,而隔离时间更长(57.4±42svs49.1±33s,p=0.04)。解剖变异的患者表现出与标准解剖组相似的ATAs复发率(5/28,17.9%)(58/401,14.5%,p=0.584;HR=1.43,CI=0.49-4.13,对数秩:p=0.4384)。在调整了混杂因素后,心力衰竭(HR=4.12,95CI:1.75-9.73,p=0.0013)和PEAF(HR=1.81,95CI:1.03-3.18,p=0.0433)在随访期间仍与ATAs复发相关.
    结论:POLARx-CB系统显示出长期疗效,还有一个安全的档案,在阵发性和PEAF患者中,无论是否存在PV变体。随访期间ATAs复发患者的隔离时间更长。
    BACKGROUND: No data have been reported on cooling characteristics and the impact of variant pulmonary vein (PV) anatomy on atrial fibrillation (AF) recurrences after POLARx cryoballoon (CB) ablation.
    OBJECTIVE: To analyze the impact of PV anatomy variants and cooling characteristics after CB ablation from a large, multicenter, prospective registry.
    METHODS: Primary endpoint was defined as 1-year absence of any atrial tachyarrhythmias (ATAs: AF/atrial flutter-tachycardia). Correlation between ATAs recurrences and anatomy variants/cooling characteristics were evaluated. The secondary outcome was the rate of major periprocedural complications.
    RESULTS: 429 consecutive patients diagnosed with paroxysmal (83.4%) or persistent AF (peAF, 16.6%) were enrolled. Twenty-eight (6.6%) patients exhibited an anatomical variant (common ostium=4.0%, adjunctive PV=2.6%). Nadir temperature, thaw time and total deflation time were different between standard PVs and PV variants. After the blanking period, over a mean of 431±99 days of follow-up, 63 patients (14.7%) suffered an ATAs recurrence. Patients with recurrences had both a shorter thaw time (18.5±7s vs 19.8±7s, p=0.0012) and total deflation time, whereas time-to-isolation was longer (57.4±42s vs 49.1±33s, p=0.04). Patients with anatomy variants showed a similar ATAs recurrence rate (5/28, 17.9%) than the standard anatomy group (58/401, 14.5%, p=0.584; HR=1.43, CI=0.49-4.13, log-rank:p=0.4384). After adjusting for confounders, heart failure (HR=4.12, 95%CI: 1.75-9.73, p=0.0013) and peAF (HR=1.81, 95%CI: 1.03-3.18, p=0.0433) remained associated to ATAs recurrence during follow-up.
    CONCLUSIONS: The POLARx-CB system demonstrated long-term efficacy, along with a safe profile, in both paroxysmal and peAF patients, regardless of the presence PV variants. Time-to-isolation was longer in patients with ATAs recurrences during follow-up.
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  • 文章类型: Journal Article
    单发装置越来越多地用于心房颤动(AF)中的肺静脉隔离(PVI)。北极前线冷冻球囊是最常用的单发技术。最近开发的新型脉冲场消融(PFA)装置(FARAPULSE)已被引入,旨在提高手术安全性和有效性。
    这项研究将比较新型FARAPULSEPFA装置和ArcticFront冷冻球囊用于有症状的阵发性房颤患者的首次PVI。
    单发冠军是一个多中心,由独立的临床事件委员会进行盲法终点判定的随机对照试验.总的来说,210例接受PVI的阵发性房颤患者在PFA和冷冻球囊消融之间以1:1的比例随机分配。在所有患者中进行使用可植入心脏监测器的连续心律监测。
    主要终点是指在消融后91天和365天内由植入式心脏监护仪确定的任何房性快速性心律失常(房颤和/或有组织的房性快速性心律失常)首次复发时间≥120秒。复合手术安全终点包括需要引流的心脏填塞,持续性膈神经麻痹,需要干预的血管并发症,中风/短暂性脑缺血发作,心房食管瘘,以及在手术期间或手术后30天内发生的死亡。关键次要终点包括(1)消融术后第1天高敏肌钙蛋白增加,(2)消融后三维电解剖标测分析(每个研究组前25名患者),(3)AF负担,(4)生活质量的变化。
    单发CHAMPION将使用新型FRAPulsePFA评估PVI对有症状阵发性房颤患者的疗效和安全性。
    UNASSIGNED: Single-shot devices are increasingly used for pulmonary vein isolation (PVI) in atrial fibrillation (AF). The Arctic Front cryoballoon is the most frequently used single-shot technology. A recently developed novel pulsed field ablation (PFA) device (FARAPULSE) has been introduced with the aim to improve procedural safety and efficacy.
    UNASSIGNED: This study will compare the novel FARAPULSE PFA device and the Arctic Front cryoballoon for first PVI in patients with symptomatic paroxysmal AF.
    UNASSIGNED: SINGLE SHOT CHAMPION is a multicenter, randomized controlled trial with blinded endpoint adjudication by an independent clinical events committee. Overall, 210 patients with paroxysmal AF undergoing their PVI are randomized 1:1 between PFA and cryoballoon ablation. Continuous rhythm monitoring with an implantable cardiac monitor is performed in all patients.
    UNASSIGNED: The primary endpoint is time to first recurrence of any atrial tachyarrhythmia (AF and/or organized atrial tachyarrhythmia) lasting ≥120 seconds and identified by the implantable cardiac monitor within 91 and 365 days postablation. The composite procedural safety endpoint includes cardiac tamponade requiring drainage, persistent phrenic nerve palsy, vascular complications requiring intervention, stroke/transient ischemic attack, atrioesophageal fistula, and death occurring during or up to 30 days after the procedure. Key secondary endpoints include (1) increase in high-sensitivity troponin on day 1 postablation, (2) analysis of postablation 3-dimensional electroanatomic mapping (first 25 patients per study group), (3) AF burden, and (4) quality-of-life changes.
    UNASSIGNED: SINGLE SHOT CHAMPION will evaluate the efficacy and safety of PVI using the novel FARAPULSE PFA for patients with symptomatic paroxysmal AF.
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  • 文章类型: Journal Article
    在射频导管消融(RFCA)和冷冻球囊消融(CBA)治疗心房颤动(AF)后,发现心肌损伤和炎症的生物标志物不同;然而,结果目前是有争议的。本研究旨在系统地比较RFCA和CBA手术后心肌损伤和炎症生物标志物的差异,并探讨其对房颤复发的影响。
    数据库,包括PubMed,Embase,Cochrane图书馆,ClinicalTrials.gov,中国国家知识基础设施(CNKI)与中国生物医学(CBM),从成立之日起至2022年5月进行了系统搜索。关注的主要结果是房颤患者CBA和RFCA手术后心肌损伤和炎症生物标志物的差异。以及生物标志物对房颤复发的影响。次要结果包括总消融时间,手术持续时间和无房性心动过速(AT)。
    最终纳入了18项研究,共1807名患者。CBA治疗与肌钙蛋白I(TNI)水平显著增加相关(加权平均差[WMD]=3.13ug/L,95%置信区间[CI]2.43-3.64)均在4-6小时(WMD=3.94ug/L),24小时(WMD=4.23ug/L),48小时(WMD=2.14ug/L)和72小时(WMD=0.56ug/L),以及4-6小时的肌酸激酶MB分数(CK-MB)水平(WMD=33.21U/L),24h(WMD=35.84U/L)和48h(WMD=4.62U/L),而在48h(WMD=-9.32mg/L)和72h(WMD=-10.90mg/L)时,RFCA治疗与消融后C反应蛋白(CRP)水平的增加相关.CBA和RFCA治疗的AT自由度相当(74.5%vs.75.2%,RR=1.08)。RFCA治疗后早期复发AF(ERAF)患者的CRP水平明显高于无ERAF患者(WMD=3.415mg/L)。
    消融后心肌损伤和炎症生物标志物的时程模式在RFCA和CBA手术中不同。术后心肌损伤生物标志物升高较低和CRP水平升高可能是ERAF的预测因素。
    CRD42021278564。
    UNASSIGNED: Biomarkers of myocardial injury and inflammation were found to be different after radiofrequency catheter ablation (RFCA) and cryoballoon ablation (CBA) for atrial fibrillation (AF); however, the results are currently controversial. This study was aimed to systematically compare the differences in myocardial injury and inflammation biomarkers after RFCA and CBA procedures and to investigate their impact on AF recurrence.
    UNASSIGNED: Databases, including PubMed, Embase, the Cochrane Library, ClinicalTrials.gov, China National Knowledge Infrastructure (CNKI) and China Biology Medicine (CBM), were systematically searched from their date of inception to May 2022. The primary outcomes of interest were the differences in myocardial injury and inflammation biomarkers after CBA and RFCA procedures for AF patients, and the impact of the biomarkers on AF recurrence. Secondary outcomes included the total ablation time, the procedure duration and the freedom from atrial tachycardia (AT).
    UNASSIGNED: Eighteen studies with a total of 1807 patients were finally enrolled. CBA treatment was associated with significantly greater increases in troponin I (TNI) levels (weighted mean difference [WMD] = 3.13 ug/L, 95% confidence interval [CI] 2.43-3.64) both at 4-6 h (WMD = 3.94 ug/L), 24 h (WMD = 4.23 ug/L), 48 h (WMD = 2.14 ug/L) and 72 h (WMD = 0.56 ug/L), and also creatine kinade MB fraction (CK-MB) levels at 4-6 h (WMD = 33.21 U/L), 24 h (WMD = 35.84 U/L) and 48 h (WMD = 4.62 U/L), while RFCA treatment was associated with greater increases in postablation C-reactive protein (CRP) levels both at 48 h (WMD = -9.32 mg/L) and 72 h (WMD = -10.90 mg/L). The CBA and RFCA treatments had comparable rates of freedom from AT (74.5% vs. 75.2%, RR = 1.08). The CRP levels were significantly higher in patients with early recurrence of AF (ERAF) than in those without ERAF after RFCA treatment (WMD = 3.415 mg/L).
    UNASSIGNED: The time-course patterns of postablation myocardial injury and inflammation biomarkers are different between RFCA and CBA procedures. The lower postprocedural elevation of myocardial injury biomarkers and the increased CRP levels may be predictive factors for ERAF.
    UNASSIGNED: CRD42021278564.
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  • 文章类型: Multicenter Study
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  • 文章类型: Journal Article
    在接受基于导管的肺静脉隔离(PVI)治疗的房颤(AF)患者中,脉冲场消融(PFA)是热消融(TA)的替代方法。然而,其有效性和安全性尚未完全阐明。
    本研究的目的是比较PFA和TA的急性和长期疗效和安全性。
    我们对进行首次PVI消融术的房颤患者的PFA和TA的随机和非随机对照试验进行了系统评价和荟萃分析。TA组分为冷冻球囊(CB)和射频亚组。将房颤患者分为阵发性房颤(PAF)和持续性房颤(PersAF)亚组进行进一步分析。
    纳入了18项研究,涉及4998名患者(35.2%PFA)。总的来说,与TA相比,PFA与较短的手术时间(平均差[MD]-21.68;95%置信区间[CI]-32.81至-10.54)相关,但透视时间更长(MD4.53;95%CI2.18-6.88)。关于安全,PFA后观察到较低的(围)食管损伤率(比值比[OR]0.17;95%CI0.06-0.46)和较高的填塞率(OR2.98;95%CI1.27-7.00).在疗效评估中,PFA与较好的首过隔离率(OR6.82;95%CI1.37-34.01)和较低的治疗失败率(OR0.83;95%CI0.70-0.98)相关。亚组分析显示PersAF和PAF没有差异。CB与较高(周围)食管损伤有关,减少PVI急性成功率和手术时间。
    与TA相比,PFA在急性和长期疗效方面显示出更好的结果,但在安全性方面存在显着差异。手术数据中(食管周围)损伤率较低,但填塞率较高。
    UNASSIGNED: Pulsed-field ablation (PFA) is an alternative to thermal ablation (TA) in patients with atrial fibrillation (AF) receiving catheter-based therapy for pulmonary vein isolation (PVI). However, its efficacy and safety have yet to be fully elucidated.
    UNASSIGNED: The purpose of this study was to compare the acute and long-term efficacies and safety of PFA and TA.
    UNASSIGNED: We performed a systematic review and meta-analysis of randomized and nonrandomized controlled trials comparing PFA and TA in patients with AF undergoing their first PVI ablation. The TA group was divided into cryoballoon (CB) and radiofrequency subgroups. AF patients were divided into paroxysmal atrial fibrillation (PAF) and persistent atrial fibrillation (PersAF) subgroups for further analysis.
    UNASSIGNED: Eighteen studies involving 4998 patients (35.2% PFA) were included. Overall, PFA was associated with a shorter procedure time (mean difference [MD] -21.68; 95% confidence interval [CI] -32.81 to -10.54) but longer fluoroscopy time (MD 4.53; 95% CI 2.18-6.88) than TA. Regarding safety, lower (peri-)esophageal injury rates (odds ratio [OR] 0.17; 95% CI 0.06-0.46) and higher tamponade rates (OR 2.98; 95% CI 1.27-7.00) were observed after PFA. In efficacy assessment, PFA was associated with a better first-pass isolation rate (OR 6.82; 95% CI 1.37-34.01) and a lower treatment failure rate (OR 0.83; 95% CI 0.70-0.98). Subgroup analysis showed no differences in PersAF and PAF. CB was related to higher (peri)esophageal injury, and lower PVI acute success and procedural time.
    UNASSIGNED: Compared to TA, PFA showed better results with regard to acute and long-term efficacy but significant differences in safety, with lower (peri)esophageal injury rates but higher tamponade rates in procedural data.
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  • 文章类型: Journal Article
    冷冻球囊消融已被确立为肺静脉隔离的有效方法,并且最近已对其在持续性房颤患者的左心房顶部区域进行基质修饰的功效进行了研究。我们在此报告了第一个成功的左心房后壁隔离的病例,包括在持续性心房颤动患者中使用冷冻球囊进行屋顶线消融。右位心,和Situs倒置。冷冻球囊消融被证明是一种安全而直接的方法,可以沿着左心房顶部线和左心房后壁产生持久的损伤。即使在具有挑战性的解剖条件下。
    Cryoballoon ablation has been established as an effective method for pulmonary vein isolation and has recently been investigated for its efficacy of substrate modification on the left atrial roof area in patients with persistent atrial fibrillation. We herein report the first successful case of left atrial posterior wall isolation including roof line ablation using cryoballoons in a patient with persistent atrial fibrillation, dextrocardia, and situs inversus. Cryoballoon ablation proved to be a safe and straightforward approach to create lasting lesions along the left atrial roof line and left atrial posterior wall, even under challenging anatomical conditions.
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  • 文章类型: Journal Article
    背景:尽管肺静脉隔离术(PVI)的疗效和安全性有了进展,房颤(AF)在PVI后复发仍然很常见.PV重新连接是治疗复发性AF的重复PVI手术期间的主要发现。
    目的:分析大量连续接受射频或冷冻球囊PVI的患者在重复消融过程中的肺静脉(PV)重新连接模式。
    方法:在德国一个大容量中心同时使用两种能源时,对基于RF和CB的连续指标PVI及其各自的再消融程序中的PV再连接模式和再消融策略进行回顾性分析。
    结果:分析了2015年1月至2021年12月31日期间363例(60%)射频和247例(40%)基于CB的指数PVI后,共进行了610例首次(2015年06月10日至2022年10月10日)和133例(2016年01日至2022年11日)重复消融手术。在第一和第二重复手术的509/610(83%)患者和74/133(56%)患者中发现了PV重新连接。最初通过CB隔离的肺静脉中的968例(48%)在首次重新消融时重新连接,但最初通过CB隔离的肺静脉中的1422例(56%)中的796例重新连接(OR:0.73[95%CI:0.62-0.86];p<.001)。这是由较少的左PV重新连接驱动的(LSPV:OR:0.60[95%CI:0.42-0.86];p=.005和LSPV:0.67[0.47-0.95];p=.026)。光伏重新连接的可能性更大,基于RF的指数PVI和老年女性。与RF-PVI后相比,CB后的重复程序更短。
    结论:重新连接仍然是PVI后重复房颤消融术的最常见原因。我们的数据表明,在指数PVI期间优先使用冷冻球囊,尤其是老年妇女。
    BACKGROUND: Despite advances in efficacy and safety of pulmonary vein isolation (PVI), atrial fibrillation (AF) recurrence after PVI remains common. PV-reconnection is the main finding during repeat PVI procedures performed to treat recurrent AF.
    OBJECTIVE: To analyze pulmonary vein (PV) reconnection patterns during repeat ablation procedures in a large cohort of consecutive patients undergoing radio frequency or cryoballoon-based PVI.
    METHODS: Retrospective analysis of PV-reconnection patterns and analysis of re-ablation strategies in consecutive index RF- and CB-based PVI and their respective re-ablation procedures during concomitant usage of both energy sources at a single high-volume center in Germany.
    RESULTS: A total of 610 first (06/2015-10/2022) and 133 s (01/2016-11/2022) repeat ablation procedures after 363 (60%) RF- and 247 (40%) CB-based index PVIs between 01/2015 and 12/2021 were analyzed. PV-reconnection was found in 509/610 (83%) patients at first and 74/133 (56%) patients at second repeat procedure. 465 of 968 (48%) initially via CB isolated PVs were reconnected at first re-ablation but 796 of 1422 initially RF-isolated PV (56%) were reconnected (OR: 0.73 [95% CI: 0.62-0.86]; p < .001). This was driven by fewer reconnections of the left PVs (LSPV: OR: 0.60 [95% CI: 0.42-0.86]; p = .005 and LSPV: 0.67 [0.47-0.95]; p = .026). PV-reconnection was more likely after longer, RF-based index PVI and in older females. Repeat procedures were shorter after CB-compared to after RF-PVI.
    CONCLUSIONS: Reconnection remains the most common reason for repeat AF ablation procedures after PVI. Our data suggest to preferentially use of the cryoballoon during index PVI, especially in older women.
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  • 文章类型: Journal Article
    肺静脉隔离(PVI)是治疗心房颤动(AF)和使用单次注射技术的金标准,如冷冻球囊消融(CBA)和脉冲场消融(PFA)使用五线导管,已获得突出地位。最近的研究假设PFA可能优于CBA,尽管手术疗效和安全性数据不一致.进行荟萃分析以比较两种治疗AF的能量来源。
    对研究结果进行了结构化的系统数据库搜索和荟萃分析,围手术期并发症,和/或接受CBA或PFA治疗的房颤患者的手术参数。纳入了来自3805名患者的11项研究报告数据。与CBA相比,PFA隔离肺静脉与房颤/房性心动过速的复发率显着降低[比值比(OR)=0.73,95%置信区间(CI)=0.54-0.98,I2=20%]和更少的围手术期并发症(OR=0.62,95%CI=0.40-0.96,I2=6%)。PFA术后并发症发生率较低主要是由于膈神经损伤较少(OR=0.19,95%CI=0.08-0.43,I2=0%)。然而,PFA后心脏压塞病例较多(OR=2.56,95%CI=1.01~6.49,I2=0%)。此外,使用PFA进行PVI与较短的总手术时间相关[平均差(MD)=-9.68,95%CI=-14.92至-4.43分钟,I2=92%]和较低的辐射暴露(MD=-148.07,95%CI=-276.50至-19.64µGy·mI2=7%)。
    我们的结果表明,PVI的PFA,与CBA相比,可以缩短手术时间,降低心律失常复发和降低围手术期并发症的风险。随机对照试验需要证实我们的发现。
    UNASSIGNED: Pulmonary vein isolation (PVI) represents the gold standard in the treatment of atrial fibrillation (AF) and the use of single-shot techniques, such as cryoballoon ablation (CBA) and pulsed field ablation (PFA) using a pentaspline catheter, has gained prominence. Recent studies hypothesize that PFA might be superior to CBA, although procedural efficacy and safety data are inconsistent. A meta-analysis was conducted to compare both energy sources for the treatment of AF.
    UNASSIGNED: A structured systematic database search and meta-analysis were performed on studies investigating outcomes, periprocedural complications, and/or procedural parameters of AF patients treated by either CBA or PFA. Eleven studies reporting data from 3805 patients were included. Pulmonary vein isolation by PFA was associated with a significantly lower recurrence of atrial fibrillation/atrial tachycardia [odds ratio (OR) = 0.73, 95% confidence interval (CI) = 0.54-0.98, I2 = 20%] and fewer periprocedural complications (OR = 0.62, 95% CI = 0.40-0.96, I2 = 6%) compared to CBA. The lower complication rate following PFA was mainly driven by fewer phrenic nerve injuries (OR = 0.19, 95% CI = 0.08-0.43, I2 = 0%). However, there were more cases of cardiac tamponades after PFA (OR = 2.56, 95% CI = 1.01-6.49, I2 = 0%). Additionally, using PFA for PVI was associated with shorter total procedure times [mean difference (MD) = -9.68, 95% CI = -14.92 to -4.43 min, I2 = 92%] and lower radiation exposure (MD = -148.07, 95% CI = -276.50 to -19.64 µGy·mI2 = 7%).
    UNASSIGNED: Our results suggest that PFA for PVI, compared to CBA, enables shorter procedure times with lower arrhythmia recurrence and a reduced risk of periprocedural complications. Randomized controlled trials need to confirm our findings.
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  • 文章类型: Journal Article
    背景:在最近一项长期持续性心房颤动(LSPAF)的随机研究中,混合收敛入路(心内膜和心外膜消融术)表现出优异的有效性。然而,缺乏现实世界,长期证据表明,与标准心内膜冷冻球囊肺静脉隔离术(CBPVI)相比,哪些患者是混合融合入路的最佳选择.
    结果:这个单中心,2010年至2015年的回顾性分析比较了两个明显不同的心房颤动(AF)队列;一个采用独立冷冻消融治疗,另一个采用混合聚合方法治疗.基线特征描述了每种方法的候选。以下标准用于确定CBPVI候选人资格:(1)阵发性房颤(PAF)(3A期),I/III类抗心律失常药物(AAD)失败,或(2)持续性/LSPAF(3B/3C/3D期),I/III类AAD失败不愿接受混合手术。混合手术的选择标准包括:(1)I/III类AAD和先前的CBPVI(3D阶段)或(2)持久性/LSPAF(3B/3C/3D阶段),I/III类AAD失败符合混合手术。先前的胸骨切开术被排除。连续心电图和连续监测评估了90天消隐期后房性心律失常首次复发的主要疗效结果。次要结果是手术相关并发症和AAD使用(出院时,12个月和36个月)。Kaplan-Meier方法评价心律失常复发。276名患者中,197(64.2±10.6岁;66.5%男性;74.1%3A-PAF;18.3%3B/3D持续性AF;1.0%3C-LSPAF;6.6%未确定)接受了CBPVI和79(61.4±8.1岁;83.5%男性;41.8%3D-PAF;45.5%3B/3D持续性AF;12.7%3C/3D-LSPAF)接受了混合手术。36个月内无心律失常的CBPVI为55.2%,杂种为50.4%(p=.32)。CBPVI组38例(19.3%)患者和混合组5例(6.3%)患者出院时使用I级AAD(p=0.01)。12个月时,14例(9.0)患者发生CBPVII级AAD利用率,而0例患者发生混合会聚(p=.004)。具有一个或多个不良事件的患者如下:CBPVI组2例(1.0%)(均为短暂性膈神经麻痹)和混合组3例(3.7%)(2例明显出血,1例伤口感染)(p=.14)。
    结论:这项研究表明,具有更复杂形式的AF(3D-PAF或3B/3C/3D-持续性/LSPAF)的患者可以通过收敛方法得到很好的治疗。在现实世界的评估中,结果与早期患者的安全性和有效性阈值相匹配,单独使用CBPVI治疗不太复杂的房颤病因。
    BACKGROUND: A hybrid convergent approach (endocardial and epicardial ablation) demonstrated superior effectiveness in a recent randomized study for long-standing persistent atrial fibrillation (LSPAF). Yet, there is a lack of real-world, long-term evidence as to which patients are best candidates for a hybrid convergent approach compared to standard endocardial cryoballoon pulmonary vein isolation (CB PVI).
    RESULTS: This single-center, retrospective analysis spanning from 2010 to 2015 compared two distinctly different atrial fibrillation (AF) cohorts; one treated with stand-alone cryoablation and one treated with a hybrid convergent approach. Baseline characteristics described candidates for each approach. The following criteria were utilized to determine CB PVI candidacy: (1) paroxysmal AF (PAF) (stage 3A) with failed class I/III antiarrhythmic drug (AAD) or (2) persistent/LSPAF (stage 3B/3C/3D) with failed class I/III AAD unwilling to undergo hybrid procedure. Selection criteria for the hybrid procedure included: (1) PAF refractory to both class I/III AAD and prior CB PVI (stage 3D) or (2) persistent/LSPAF (stage 3B/3C/3D) with failed class I/III AAD agreeable to hybrid procedure. Prior sternotomy was excluded. Serial electrocardiograms and continuous monitoring evaluated primary efficacy outcome of time-to-first recurrence of atrial arrhythmia after a 90-day blanking period. Secondary outcomes were procedure-related complications and AAD use (at discharge, 12, and 36 months). Kaplan-Meier methods evaluated arrhythmia recurrence. Of 276 patients, 197 (64.2 ± 10.6 years old; 66.5% male; 74.1% 3A-PAF; 18.3% 3B/3D-persistent AF; 1.0% 3C-LSPAF; 6.6% undetermined) underwent CB PVI and 79 (61.4 ± 8.1 years old; 83.5% male; 41.8% 3D-PAF; 45.5% 3B/3D-persistent AF; 12.7% 3C/3D-LSPAF) underwent hybrid procedure. Arrhythmia freedom through 36 months was 55.2% for CB PVI and 50.4% for hybrid (p = .32). Class I AAD utilization at discharge occurred in 38 (19.3%) patients in the CB PVI group and 5 (6.3%) patients in the hybrid group (p = .01). CB PVI class I AAD utilization at 12 months occurred in 14 (9.0) patients versus 0 patients for hybrid convergent (p = .004). Patients with one or more adverse event were as follows: two (1.0%) in the CB PVI group (both transient phrenic nerve palsy) and three (3.7%) in the hybrid group (two with significant bleeding and one with wound infection) (p = .14).
    CONCLUSIONS: This study demonstrated that patients with more complex forms of AF (3D-PAF or 3B/3C/3D-persistent/LSPAF) could be well managed with a convergent approach. In a real-world evaluation, outcomes match safety and efficacy thresholds achieved for patients with earlier, less complex AF etiologies treated by CB PVI alone.
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