cryoballoon

冷冻球囊
  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    目的:心房颤动(AF)消融术中微栓塞信号(MES)的意义尚不清楚。以前的研究有局限性,冷冻球囊(CB)消融患者的代表性不足。由于不确定的神经认知影响,建议最小化MES。
    方法:这项前瞻性观察性研究包括2021年2月至2022年8月来自德国中心的房颤患者。患者平均分为阵发性(A组)和持续性(B组)AF。A组仅接受CB-PVI,而B组也进行了左房顶消融。消融期间使用经颅多普勒超声检查检测MES。使用CERADPlus电池在手术前和手术后以及3个月时评估神经认知状态。
    结果:该研究分析了100名中位年龄为65.5岁的患者。共观察到19,698个MES,80%是气态的,20%是固态的,主要发生在肺静脉造影和球囊冻融阶段。每位患者的MES中位数为130(IQR92-256),298(IQR177-413)双边(36%),和110(IQR71-130)在单侧(64%)记录。两组之间的MES总数没有显着差异。11项神经心理学测试均未显示术后或3个月时的认知能力下降。
    结论:我们的观察结果证实,使用CB技术进行房颤消融术后24小时或3个月,神经认知能力均不受影响。然而,尽管与CB相关的MES负担较低,需要做更多的工作来减少房颤消融术期间的小栓塞事件.
    OBJECTIVE: The significance of micro-embolic signals (MES) during atrial fibrillation (AF) ablation is unclear. Previous studies had limitations, and cryoballoon (CB) ablation patients were underrepresented. Minimizing MES is recommended due to their uncertain neurocognitive impact.
    METHODS: This prospective observational study included AF patients from a German center between February 2021 and August 2022. Patients were equally divided into paroxysmal (Group A) and persistent (Group B) AF. Group A received CB-PVI only, while Group B also had left atrial roof ablation. MES were detected using transcranial Doppler ultrasonography during ablation. Neurocognitive status was assessed pre- and post-procedure and at 3 months using the CERAD Plus battery.
    RESULTS: The study analyzed 100 patients with a median age of 65.5 years. A total of 19,698 MES were observed, with 80% being gaseous and 20% solid in origin, primarily occurring during pulmonary vein angiography and the balloon freeze and thawing phase. The median MES per patient was 130 (IQR 92-256) in total, 298 (IQR 177-413) in bilateral (36%), and 110 (IQR 71-130) in unilateral (64%) recordings. No significant difference in total MES counts was found between the groups. None of the eleven neuropsychological tests showed cognitive decline post-procedure or at 3 months.
    CONCLUSIONS: Our observations confirm that neurocognitive abilities are not affected either 24 hours or 3 months after AF ablation using the CB technique. However, despite the low MES burden associated with the CB, more work is needed to reduce small embolic events during AF ablation.
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  • 文章类型: Journal Article
    目的:脉冲场消融(PFA)是一种新兴的肺静脉隔离(PVI)技术。初步数据显示高安全性和有效性。与已建立的PVI能源相比,长期PVI耐久性和再传导模式的数据很少。我们将第一次脉冲场消融(PFA)后重复消融程序的结果与第一次基于冷冻球囊消融(CBA)的PVI后重复消融程序的结果进行比较。
    方法:550例连续入组患者接受PFA或CBA指数PVI。分析了有症状的房性心律失常复发患者的重复消融。
    结果:共有22/191(12%)患者在指数PFA-PVI后和44/359(12%)患者在CBA-PVI后接受了重复消融。通过多极螺旋标测导管在每个PV处检测到任何肺静脉(PV)的重建,并仔细评估PV电位,并通过3D标测在PFA-PVI后的16/22患者(73%)和CBA-PVI后的33/44(75%)(p=1.000)。在PFA-PVI后最初分离的82个PV中,31例(38%)正在重新进行;在CBA-PVI后的169个孤立的PVs中,63例(37%)正在重新进行(p=0.936)。PFA(5/22;23%)和CBA(7/44;16%;p=0.515)后患者的临床房性心动过速发生相似。与CBA-PVI(5/44;11%;p=0.023)相比,PFA-(8/22;36%)后更频繁地设置屋顶线。重复消融时,重复手术持续时间(PFA:87[76,123]min;CBA:93[75,128]min;p=0.446)相似,透视时间(PFA:11[9,14]min;CBA:11[8,14]min;p=0.739)在重复消融时组间相等。
    结论:在先前基于PFA或CBA的PVI后重复消融期间,电PV复导率和模式相似。
    OBJECTIVE: Pulsed-field ablation (PFA) is an emerging technology to perform pulmonary vein isolation (PVI). Initial data demonstrated high safety and efficacy. Data on long-term PVI durability and reconduction patterns in comparison to established energy sources for PVI are scarce. We compare findings in repeat ablation procedures after a first PFA to findings in repeat ablation procedures after a first cryoballoon ablation (CBA) based PVI.
    RESULTS: A total of 550 consecutively enrolled patients underwent PFA or CBA index PVI. Repeat ablations in patients with symptomatic atrial arrhythmia recurrences were analysed. A total of 22/191 (12%) patients after index PFA-PVI and 44/359 (12%) after CBA-PVI underwent repeat ablation. Reconduction of any pulmonary vein (PV) was detected by multipolar spiral mapping catheter at each PV with careful evaluation of PV potentials and by 3D-mapping in 16/22 patients (73%) after PFA-PVI and in 33/44 (75%) after CBA-PVI (P = 1.000). Of 82 initially isolated PVs after PFA-PVI, 31 (38%) were reconducting; of 169 isolated PVs after CBA-PVI, 63 (37%) were reconducting (P = 0.936). Clinical atrial tachycardia occurred similarly in patients after PFA (5/22; 23%) and CBA (7/44; 16%; P = 0.515). Roof lines were set more often after PFA- (8/22; 36%) compared with CBA-PVI (5/44; 11%; P = 0.023). Repeat procedure duration [PFA: 87 (76, 123) min; CBA: 93 (75, 128) min; P = 0.446] was similar and fluoroscopy time [PFA: 11 (9, 14) min; CBA: 11 (8, 14) min; P = 0.739] equal between groups at repeat ablation.
    CONCLUSIONS: During repeat ablation after previous PFA- or CBA-based PVI, electrical PV-reconduction rates and patterns were similar.
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  • 文章类型: Journal Article
    心房颤动(AF)对心血管疾病提出了重大挑战,影响患者健康和经济负担。了解房颤对左心房(LA)的机械影响并评估治疗方式对LA功能的影响至关重要。本研究旨在评估超声心动图和生化参数在预测第二代冷冻球囊消融(CB-2)后房颤复发中的功效。92例房颤患者,在伊斯坦布尔大学-Cerrahpaša用CB-2治疗,医学院,心内科,从2021年1月至2023年7月进行了前瞻性检查。本研究致力于建立房颤复发的预测模型,研究超声心动图测量值和血清生物标志物与复发之间的关系。系统记录了超声心动图评估和生化分析的随访持续时间。研究显示,在术后三个月的超声心动图随访中,LA的机械功能显着增强。具体来说,LA应变参数是复发的重要预测因子(LAsr:95CI1.004-1.246,p=0.047;LAsct:95CI1.040-1.750,p=0.024)。生化分析表明,PRO-BNP水平升高与复发风险增加之间存在相关性(95CI1.000-1.003,p=0.012)。此外,特定的生物标志物,如MYBPHL,这表明手术后水平增加,被认为是心房损伤的指示,提示PVI以外的潜在心房底物修饰。因此,冷冻球囊消融后LA功能的改善和生化标志物已成为预测AF复发的潜在指标.本研究阐明了CB-2治疗AF的有效性及其对LA功能的影响。值得注意的是,LA应变测量和PRO-BNP水平已成为预测复发的可靠指标。除了临床意义,我们的研究为更深入地了解CB-2在房颤管理中的作用和复发相关因素奠定了基础.
    Atrial fibrillation (AF) poses substantial challenges in cardiovascular diseases, impacting patient health and economic burdens. Understanding the mechanical effects of AF on the left atrium (LA) and assessing the influence of treatment modalities on LA functions are critical. This study aims to assess the efficacy of echocardiographic and biochemical parameters in predicting AF recurrence following second generation cryoballoon ablation (CB-2). Ninety-two patients with symptomatic AF, treated with CB-2 at Istanbul University-Cerrahpaşa, Faculty of Medicine, Department of Cardiology, were prospectively examined from January 2021 to July 2023. The study endeavors to develop a predictive model for AF recurrence, investigating the relationship between echocardiographic measurements and serum biomarkers with recurrence. The follow-up duration for echocardiographic assessments and biochemical analyses was systematically documented. The study revealed a significant enhancement in LA mechanical functions during echocardiographic follow-ups three months post-procedure. Specifically, LA strain parameters emerged as significant predictors of recurrence (LAsr: 95%CI 1.004-1.246, p = 0.047; LAsct: 95%CI 1.040-1.750, p = 0.024). Biochemical analyses demonstrated a correlation between elevated PRO-BNP levels and an increased risk of recurrence (95%CI 1.000-1.003, p = 0.012). Moreover, specific biomarkers such as MYBPHL, which demonstrated increased levels post-procedure, were deemed indicative of atrial damage, suggesting potential additional atrial substrate modification beyond PVI. Consequently, improvements in LA function post-cryoballoon ablation and biochemical markers have surfaced as potential indicators for predicting AF recurrence. This study elucidates the effectiveness of CB-2 in treating AF and its impact on LA functions. Notably, LA strain measurements and PRO-BNP levels have emerged as reliable indicators for predicting recurrence. Beyond clinical implications, our research establishes a foundation for a deeper understanding of the role of CB-2 in AF management and factors associated with recurrence.
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  • 文章类型: Journal Article
    目前,两种类型的冷冻球囊(CB)系统可用于心房颤动(AF)的导管消融.由于POLARx(波士顿科学公司)在冻结期间比北极前线前进Pro(AFA-Pro;Medtronic)更柔软,它倾向于更深入地进入肺静脉(PV),有肺静脉狭窄的风险。
    91名患者接受了阵发性房颤的初始CB消融术(AFA-Pro56;POLARx35)。使用倾向评分匹配从每组中提取26个。通过在PV平面内以5mm的间隔从PV口沿远侧方向追踪20mm或到每个PV中的分叉来测量PV横截面积(PVA)。对比消融前和消融后3个月的PVA。
    与AFA-Pro相比,POLARx的气球温度达到-30和-40°C的时间明显更短,最低点温度明显更低。在左下(LI)PV和右上(RS)PV中,POLARx的冷冻气球位置明显比AFA-pro深。轻度至中度狭窄的RSPV中的冻结位置比没有(10.2±3.3mmvs.8.2±1.8mm,p=.01)。在RSPV中,与AFA-Pro相比,POLARx对PVA的减少倾向于更大(26.1%±14.1%vs.19.9%±10.3%,p=.07)。
    POLARx和AFA-Pro之间的PV狭窄发生率没有显着差异。然而,如果POLARx深入PV,我们还是要小心。
    UNASSIGNED: Currently, two types of cryoballoon (CB) systems are available for catheter ablation of atrial fibrillation (AF). Since the POLARx (Boston Scientific) is softer during freezing than the Arctic Front Advance Pro (AFA-Pro; Medtronic), it tends to go more deeply into the pulmonary vein (PV), risking PV stenosis.
    UNASSIGNED: Ninety-one patients underwent initial CB ablation for paroxysmal AF (AFA-Pro 56; POLARx 35). Twenty-six from each group were extracted using propensity score matching. The PV cross-sectional area (PVA) was measured by tracing the area within the PV plane at 5-mm intervals from the PV ostium in a distal direction for 20 mm or to the bifurcation in each PV. The PVA was compared before and 3 months after ablation.
    UNASSIGNED: Time to balloon temperatures of -30 and - 40°C was significantly shorter and the nadir temperature was significantly lower with POLARx than with AFA-Pro. In the left inferior (LI) PV and right superior (RS) PV, the freezing balloon position was significantly deeper in POLARx than in AFA-pro. The freezing position in RSPV with mild to moderate narrowing was deeper than those without (10.2 ± 3.3 mm vs. 8.2 ± 1.8 mm, p = .01). In RSPV, the reduction of PVA tended to be greater with the POLARx than with the AFA-Pro (26.1% ± 14.1% vs. 19.9% ± 10.3%, p = .07).
    UNASSIGNED: There was no significant difference in the incidence of PV stenosis between POLARx and AFA-Pro. However, if POLARx goes deep into the PVs, we will still have to be careful.
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  • 文章类型: Journal Article
    背景:冷冻球囊消融治疗心房颤动(AF)可缩短手术时间,但有关其对中欧和东欧(CEE)电生理(EP)实验室效率的影响的数据有限。使用CEE特定的程序数据,本研究对EP实验室资源消耗的冷冻球囊消融程序进行了建模,以提高效率。
    方法:开发了离散事件模拟模型来评估冷冻球囊消融的EP效率。模型输入来自Cryo全球登记处的CEE站点,即捷克共和国,匈牙利,波兰,塞尔维亚,斯洛伐克。主要终点是导致加班的天数百分比和一个额外的简单EP程序随时间的天数百分比。还检查了使用\'8\'(Fo8)闭合技术来减少手术时间。
    结果:所有CEE站点的平均实验室占用时间为133±47分钟(分钟:104分钟,最大:181分钟)。在基本情况下,冷冻球囊消融导致14.6%的超时天数和64.8%的额外简单EP程序的时间。使用Fo8闭合技术将这些值提高到5.5%和85.3%,分别。模型终点对实验室占用时间和加班开始时间的变化最敏感。
    结论:在这项针对CEE的EP实验室效率的分析中,发现可以在1个实验室天进行3次冷冻球囊消融手术,在大多数日子里,为第4次简单EP手术留出时间。因此,使用冷冻球囊消融治疗PVI是提高EP实验室效率的有效途径。
    BACKGROUND: Cryoballoon ablation for treatment of atrial fibrillation (AF) reduces procedure times, but limited data is available about its impact on electrophysiology (EP) lab efficiency in Central and Eastern Europe (CEE). Using CEE-specific procedure data, the present study modeled cryoballoon ablation procedures on EP lab resource consumption to improve efficiency.
    METHODS: A discrete event simulation model was developed to assess EP efficiency with cryoballoon ablation. Model inputs were taken from CEE sites within the Cryo Global Registry, namely Czech Republic, Hungary, Poland, Serbia, and Slovakia. The main endpoints were percentage of days that resulted in overtime and percentage of days with time for one extra simple EP procedure. Use of the \'figure of 8\' (Fo8) closure technique to reduce procedure time was also examined.
    RESULTS: The mean lab occupancy time across all CEE sites was 133 ± 47 minutes (min: 104 minutes, max:181 minutes). Cryoballoon ablation in the base-case scenario resulted in 14.6% of days with overtime and 64.8% of days with time for an extra simple EP procedure. Use of the Fo8 closure technique enhanced these values to 5.5% and 85.3%, respectively. Model endpoints were most sensitive to changes in lab occupancy times and overtime start time.
    CONCLUSIONS: In this CEE-specific analysis of EP lab efficiency it was found that 3 cryoballoon ablation procedures could be performed in 1 lab day, leaving time for a 4th simple EP procedure on most days. As such, use cryoballoon ablation for PVI is an effective way to improve EP lab efficiency.
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  • 文章类型: Journal Article
    目的:仅使用冷冻球囊(CB)成功的左心房后壁隔离(LAPWI)对于心房颤动(AF)的治疗在技术上具有挑战性。本研究旨在评估交叉技术的疗效,其中通过将CB从两个方向放置成与LAPW接触来执行重叠消融。
    方法:这是一个单中心,回顾性,对194例持续性心房颤动(PerAF)患者进行观察性研究,这些患者首次接受了使用CB的肺静脉隔离术(PVI)+PWI(108例)或仅接受PVI(86例)。交叉技术已在所有LAPWI中应用。
    结果:对于LA顶部和底部的消融,分别,平均8.6±1.0(从右到左[R→L]4.3±1.1,从左到右[L→R]4.3±1.1)和9.1±1.2(R→L4.6±1.6和L→R4.5±1.2)CB应用已交付。在99.1%的患者中仅使用CB成功分离了LAPW。虽然PVI+PWI组的手术时间明显更长,两组均未出现严重不良事件.在19个月的中位随访中,所有房性快速性心律失常的无复发在PVI+PWI组93.5%和仅PVI组72.9%(p=.011).
    结论:仅使用交叉技术与CB进行LAPWI是可行的,安全,在PerAF患者中,与单纯PVI相比,与房性快速性心律失常复发的发生率明显更高独立相关。
    OBJECTIVE: Successful left atrial posterior wall isolation (LAPWI) using only the cryoballoon (CB) is technically challenging for the treatment of atrial fibrillation (AF). This study aimed to evaluate the efficacy of the cross-over technique, wherein an overlapped ablation is performed by placing the CB from both directions in contact with the LAPW.
    METHODS: This was a single-center, retrospective, observational study of 194 consecutive patients with persistent atrial fibrillation (PerAF) who underwent a first-time procedure of pulmonary vein isolation (PVI) + PWI (108 patients) or PVI-only (86 patients) using the CB. The cross-over technique was applied in all LAPWI.
    RESULTS: For ablation of the LA roof and bottom, respectively, a mean of 8.6 ± 1.0 (right to left [R→L] 4.3 ± 1.1 and left to right [L→R] 4.3 ± 1.1) and 9.1 ± 1.2 (R→L 4.6 ± 1.6 and L→R 4.5 ± 1.2) CB applications were delivered. LAPW was successfully isolated solely using the CB in 99.1% of patients. Although the PVI + PWI group had significantly longer procedure time, no severe adverse events were observed in either group. During a median follow-up of 19 months, freedom from recurrence of all atrial tachyarrhythmias was achieved in 93.5% of the PVI + PWI group and 72.9% of the PVI-only group (p = .011).
    CONCLUSIONS: LAPWI performed solely with the CB using the cross-over technique is feasibly, safe, and was independently associated with a significantly higher freedom from recurrence of atrial tachyarrhythmias compared with PVI alone in patients with PerAF.
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  • 文章类型: Case Reports
    鞘中鞘技术,利用插入25厘米16Fr鞘的15Fr冷冻球囊输送鞘,在冷冻球囊消融治疗心房颤动期间有效地导航曲折的髂静脉,确保安全交付和保持必要的设备性能没有并发症。
    The sheath-in-sheath technique, utilizing a 15Fr cryoballoon delivery sheath inserted into a 25 cm 16Fr sheath, effectively navigates tortuous iliac veins during cryoballoon ablation for atrial fibrillation, ensuring safe delivery and maintaining essential device performance without complications.
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  • 文章类型: Journal Article
    球囊导管消融术是治疗心房颤动(AF)的一个有价值的选择,因为可以创建连续的损伤来实现肺静脉隔离(PVI)。与传统的消融方法相比,该方法对操作员的技能和经验的依赖性较小。冷冻球囊消融在世界范围内被普遍使用,其疗效和安全性与标准射频消融的疗效和安全性相当,并且该过程可以在相对较短的时间内完成。热球囊消融是在日本开发的。即使在能量输送过程中,气球也能保持其顺应性,并产生大面积消融损伤。此外,热气球系统是唯一一个以食道冷却为标准功能的系统。激光球囊烧蚀,在内窥镜直视下进行,已被证明是有效和安全的实现PVI。激光球囊系统为快速和有效的PVI提供了改进的视场和自动圆周消融。作者回顾了目前可用的用于房颤消融的球囊系统,即,PVI,并对当前可用的冷冻气球和热气球技术提供了详细的见解和观点,加上激光气球技术。
    Balloon-based catheter ablation is a valuable option for the treatment of atrial fibrillation (AF) because contiguous lesions can be created to achieve pulmonary vein isolation (PVI), and the method is less dependent than traditional ablation methods on the operator\'s skill and experience. Cryoballoon ablation is used universally worldwide, with its efficacy and safety being comparable to the efficacy and safety of standard radiofrequency ablation, and the procedure can be completed in a relatively short time. Hot balloon ablation was developed in Japan. The balloon maintains its compliance even during the energy delivery, and a large areal ablation lesion is created. Furthermore, the hot balloon system is the only system for which oesophageal cooling is a standard feature. Laser balloon ablation, which is performed under direct endoscopic vision, has proven to be effective and safe for achieving a PVI. The laser balloon system provides an improved field of view and automated circumferential ablation for a rapid and effective PVI. The authors have reviewed the currently available balloon systems as used for AF ablation, i.e., PVI, and have provided detailed insight and perspectives on the currently available cryoballoon and hot balloon technologies, plus laser balloon technology.
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  • 文章类型: Journal Article
    在将其引入临床实践后,冷冻球囊(CB)已被证明是阵发性和持续性心房颤动(AF)患者肺静脉隔离术(PVI)的替代方法.与标准射频程序相比,CB方法导致更短的操作时间和学习曲线以及更高的可重复性。最近市场上推出了一种新的冷冻球囊(NCB)。在这次审查中,我们解决了以下问题:新系统在技术上与以前的系统相似吗?在围手术期参数方面是否有差异?急性成功率和并发症发生率是否相似?学习曲线是否不同?
    Following its introduction into clinical practice, the cryoballoon (CB) has proved to be an alternative for pulmonary vein isolation (PVI) in patients with paroxysmal and persistent atrial fibrillation (AF). In comparison with the standard radiofrequency procedure, the CB method results in a shorter procedure time and learning curve as well as a higher degree of reproducibility. A new cryoballoon (NCB) was recently introduced on the market. In this review, we addressed the following questions: Is the new system technically similar to the previous one? Is there a difference in terms of periprocedural parameters? Are acute success and complication rates similar? Is the learning curve different?
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