Pulsed-field ablation

脉冲场消融
  • 文章类型: Journal Article
    背景:心房颤动(AF)的脉冲场消融(PFA)是临床实践中的一种新方法。尽管PFA在房颤消融术中具有良好的安全性,罕见的肾衰竭病例,可能是溶血,最近有报道。
    目的:这项研究的目的是确定在不同电场强度的体外PFA过程中溶血和心肌细胞死亡的速率。
    方法:使用216个双极脉冲对健康志愿者和小鼠HL-1心肌细胞系的血液样本进行体外不可逆电穿孔(IRE),每个持续2μs,间隔5μs,以1Hz的频率重复20次。这些脉冲在500到1500V之间变化。用分光光度法评估无细胞血红蛋白水平,使用流式细胞术评估红细胞微粒(RBCμ)。使用碘化丙锭定量心肌细胞死亡。
    结果:PF能量(1000V/cm,1250V/cm,和1500V/cm)与无细胞血红蛋白显着增加(0.31±0.16g/l,2.33±0.90g/l,和5.7±0.20g/l,p<0.05),RBCμ浓度的增加相似。在750V/cm的电场强度下观察到显著的心肌细胞死亡率,1000V/cm,1250V/cm和1500V/cm(26.5±5.9%,44.3±6.2%,55.5±6.9%和74.5±17.8%的心肌细胞,p<0.05)。
    结论:在1500V/cm下观察到最有效的体外细胞死亡诱导。这种强度也与显著程度的溶血有关。
    BACKGROUND: Pulsed-field ablation (PFA) of atrial fibrillation (AF) is a new method in clinical practice. Despite a favorable safety profile of PFA in AF ablation, rare cases of renal failure, probably due to hemolysis, have been recently reported.
    OBJECTIVE: The aim of this study was to determine the rate of hemolysis and cardiac cell death during in vitro PFA with different electric field intensities.
    METHODS: Blood samples from healthy volunteers and mouse HL-1 cardiomyocyte cell lines were subjected to in vitro irreversible electroporation (IRE) using 216 bipolar pulses, each lasting 2 μs with 5 μs intervals, repeated 20 times at a frequency of 1 Hz. These pulses varied in from 500 to 1500 V. Cell-free hemoglobin levels were assessed spectrophotometrically, and red blood cell microparticles (RBCμ) were evaluated using flow cytometry. Cardiomyocyte death was quantified using propidium iodide.
    RESULTS: PF energy (1000 V/cm, 1250 V/cm, and 1500 V/cm) was associated with a significant increase in cell-free hemoglobin (0.31 ± 0.16 g/l, 2.33 ± 0.90 g/l, and 5.7 ± 0.20 g/l, p< 0.05), and similar increase in the concentration of RBCμ. Significant rates of cardiomyocyte death were observed at electric field strengths of 750 V/cm, 1000 V/cm, 1250 V/cm and 1500 V/cm (26.5 ± 5.9%, 44.3 ± 6.2%, 55.5 ± 6.9% and 74.5 ± 17.8% of cardiomyocytes, p < 0.05).
    CONCLUSIONS: The most effective induction of cell death in vitro was observed at 1500 V/cm. This intensity was also associated with a significant degree of hemolysis.
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  • 文章类型: Journal Article
    背景:心房颤动(AF)射频消融术后3个月消隐期的复发通常不被视为晚期复发的预测因子。
    目的:我们研究了在接受脉冲场消融术(PFA)的房颤患者中,早期复发作为晚期复发的危险因素的意义。
    方法:对连续接受PFA的患者进行为期1年的前瞻性随访。所有患者均接受肺静脉隔离术。根据操作员的判断进行了额外的消融。手术后,在2个月的空白期内,所有人都保留了以前无效的抗心律失常药物(AAD),此后停用了AAD。早期复发被定义为在3个月的消隐期持续>30秒的房性心律失常,任何超过3个月的复发被认为是晚期复发。
    结果:共337例接受PFA治疗的房颤患者。53例(15.7%)患者早期复发;10例患者在第1个月,第2个月为12个,第3个月为31个。在1个月内复发的10名患者中,心脏复律后仍有7例(70%)保持窦性心律,而3例(30%)由于晚期复发而进行了重做。在1年,所有在第2个月和第3个月复发的患者,经历了晚期复发,其中10/12和27/31接受了重做,其余6例患者在AAD上窦房结。
    结论:在这一系列连续的房颤患者中,PFA术后2个月或3个月的早期复发与晚期复发的高风险相关.因此,消隐期可以重新定义为PFA后的1个月。
    BACKGROUND: Recurrence during the 3-month blanking period following radiofrequency ablation of atrial fibrillation (AF) is typically not considered as a predictor for late recurrence.
    OBJECTIVE: We investigated the significance of early recurrence as a risk factor for late recurrence in AF patients receiving pulsed-field ablation (PFA).
    METHODS: Consecutive patients undergoing PFA were prospectively followed-up for 1 year. All patients received isolation of pulmonary veins. Additional ablations were performed per operator\'s discretion. Following the procedure all remained on their previously ineffective antiarrhythmic drugs (AAD) during the 2-month blanking period after which the AADs were discontinued. Early recurrence was defined as atrial arrhythmia of > 30 second duration during the 3-mo blanking period and any recurrence beyond 3-mo was considered as late recurrence.
    RESULTS: A total of 337 patients undergoing PFA for AF were included. Early recurrence was recorded in 53 (15.7%) patients; 10 in the 1st month, 12 in the 2nd month and 31 in the 3rd month. Of the 10 patients having recurrence during the 1st month, 7 (70%) remained in sinus rhythm after cardioversion whereas 3 (30%) underwent redo because of late-recurrence. At 1 year, all patients with recurrence during the 2nd and 3rd month, experienced late-recurrence of which 10/12 and 27/31 underwent redo and the remaining 6 patients were in sinus on-AAD.
    CONCLUSIONS: In this consecutive series of AF patients, early-recurrence in the 2nd or 3rd month following the PFA procedure was associated with high risk of late-recurrence. Thus, blanking period could be redefined as 1-month following PFA.
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  • 文章类型: Case Reports
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  • 文章类型: Journal Article
    目的:心房颤动导管消融期间上腔静脉(SVC)的隔离受到窦房结和/或膈神经附带损伤风险的限制。由于其组织特异性,我们假设基于脉冲场消融(PFA)的SVC隔离的可行性和安全性.
    结果:前瞻性纳入了105例接受基于PFA的AF导管消融的连续患者。肺静脉隔离(±后壁隔离和电复律)后,使用标准化工作流程进行SVC隔离。应用6±1次后,105/105(100%)患者实现了急性SVC隔离。67/105(64%)的患者发生了暂时性膈神经顿抑,但在手术结束和出院时没有膈神经麻痹。5/105(4.7%)患者出现短暂性高度窦房结功能障碍,在手术结束和出院之前没有复发。在为期3个月的随访中,无并发症发生。
    结论:使用PentasplinePFA导管进行SVC隔离是可行且安全的。
    OBJECTIVE: Superior vena cava (SVC) isolation during atrial fibrillation catheter ablation is limited by the risk of collateral damage to the sinus node and/or the phrenic nerve. Due to its tissue-specificity, we hypothesized the feasibility and safety of pulsed-field ablation (PFA)-based SVC isolation.
    RESULTS: One hundred and five consecutive patients undergoing PFA-based AF catheter ablation were prospectively included. After pulmonary vein isolation (±posterior wall isolation and electrical cardioversion), SVC isolation was performed using a standardized workflow. Acute SVC isolation was achieved in 105/105 (100%) patients after 6 ± 1 applications. Transient phrenic nerve stunning occurred in 67/105 (64%) patients but without phrenic nerve palsy at the end of the procedure and at hospital discharge. Transient high-degree sinus node dysfunction occurred in 5/105 (4.7%) patients, with no recurrence at the end of the procedure and until discharge. At the 3-month follow-up visit, no complication occurred.
    CONCLUSIONS: SVC isolation using a pentaspline PFA catheter is feasible and safe.
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  • 文章类型: Journal Article
    脉冲场消融(PFA)已成为治疗心房颤动(AF)的一种有前途的非热消融替代方法。通过提供超快的高能电脉冲,PFA诱导不可逆电穿孔,选择性地靶向心肌组织,同时避免邻近的结构受到热或其他损害。本文对多项临床前研究进行了全面综述,临床研究,和评估安全性的临床试验,功效,以及PFA在各种环境和患者人群中的长期结局。总的来说,审查的证据强调了PFA作为房颤治疗革命性消融策略的潜力.提供与常规消融方法相当的手术疗效,PFA的特点是手术时间短,并发症的风险降低,如膈神经麻痹和潜在的食道损伤。虽然需要进一步的研究来确定长期疗效,PFA的独特优势和不断发展的临床证据表明,这种新型非热消融方法具有广阔的前景。随着PFA的不断进步,它有可能改变房颤消融术,为房颤患者提供更安全的选择。
    Pulsed-field ablation (PFA) has emerged as a promising nonthermal ablation alternative for treating atrial fibrillation (AF). By delivering ultra-rapid high-energy electrical pulses, PFA induces irreversible electroporation, selectively targeting myocardial tissue while sparing adjacent structures from thermal or other damage. This article provides a comprehensive review of multiple pre-clinical studies, clinical studies, and clinical trials evaluating the safety, efficacy, and long-term outcomes of PFA in various settings and patient populations. Overall, the reviewed evidence highlights PFA\'s potential as a revolutionary ablation strategy for AF treatment. Offering comparable procedural efficacy to conventional ablation methods, PFA distinguishes itself with shorter procedure times and reduced risks of complications such as phrenic nerve palsy and potential esophageal injury. While further research is warranted to establish long-term efficacy, PFA\'s distinct advantages and evolving clinical evidence suggest a promising future for this novel nonthermal ablation approach. As PFA continues to advance, it has the potential to transform AF ablation procedures, providing a safer alternative for patients with atrial fibrillation.
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  • 文章类型: Journal Article
    脉冲场消融(PFA)是一种新兴的消融技术,已成功用于消除心律失常。作为非热技术,其具有优于传统射频消融的显著益处,具有改善的靶组织特异性和降低的心脏应用期间的不良事件风险。我们调查了PFA在胃中使用是否安全,以及它是否可以调节胃慢波。雌性断奶猪禁食过夜,然后使用盐酸替利塔明(50mgmL-1)和盐酸唑拉西泮(50mgmL-1)诱导麻醉,并用异丙酚维持(Diprivan2%,0.2‑0.4mgkg‑1min‑1)。在体内对其胃浆膜进行脉冲场消融。使用由40个脉冲组成的双极脉冲场消融(10Hz频率,0.1ms脉冲宽度,1000V振幅)。高分辨率电标测定义了基线和消融后胃慢波模式。在苏木精和曙红染色的图像中使用经过验证的五点量表来评估组织损伤。结果表明,PFA在所有情况下都成功诱导了完全传导阻滞,具有贯穿胃肌肉层整个厚度的病变。消融后立即出现一致的消融后慢波模式,并在研究期间持续存在。脉冲场消融引起快速传导阻滞,作为调节慢波模式的工具,表明它可能适合作为射频消融的替代方案。
    Pulsed-field ablation (PFA) is an emerging ablative technology that has been used successfully to eliminate cardiac arrhythmias. As a non-thermal technique it has significant benefits over traditional radio-frequency ablation with improved target tissue specificity and reduced risk of adverse events during cardiac applications. We investigated whether PFA is safe for use in the stomach and whether it could modulate gastric slow waves. Female weaner pigs were fasted overnight before anesthesia was induced using tiletamine hydrochloride (50 mg mL-1) and zolazepam hydrochloride (50 mg mL-1) and maintained with propofol (Diprivan 2%, 0.2‑0.4 mg kg‑1 min‑1). Pulsed-field ablation was performed on their gastric serosa in vivo. Adjacent point lesions (n=2-4) were used to create a linear injury using bipolar pulsed-field ablation consisting of 40 pulses (10 Hz frequency, 0.1 ms pulse width, 1000 V amplitude). High-resolution electrical mapping defined baseline and post-ablation gastric slow-wave patterns. A validated five-point scale was used to evaluate tissue damage in hematoxylin and eosin stained images. Results indicated that PFA successfully induced complete conduction blocks in all cases, with lesions through the entire thickness of the gastric muscle layers. Consistent post-ablation slow-wave patterns emerged immediately following ablation and persisted over the study period. Pulsed-field ablation induces rapid conduction blocks as a tool to modulate slow-wave patterns, indicating it may be suitable as an alternative to radio-frequency ablation.
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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
    目的:通过集成三维标测系统和逐点消融策略,技术进步有助于提高脉冲场消融(PFA)的精度和损伤灵活性。关于该技术的可行性的数据仍然限于一些临床试验。本研究旨在阐明在持续性心房颤动(AF)患者中使用点阵尖端局灶性PFA/射频消融(RFA)导管进行导管消融的初始真实世界数据。
    结果:连续入组通过格子尖PFA/RFA导管进行持续性房颤导管消融术的患者。我们评估了急性手术数据,包括围手术期数据以及90天空白期内的临床随访。总的来说,28例持续性房颤患者在全身麻醉(n=6)或深度镇静(n=22)下进行了房颤消融。在所有患者中,成功实现了肺静脉隔离。对21例患者(78%)进行了额外的线性消融,并结合了成功的前线(n=13,46%)和屋顶线(n=19,68%)。中位手术时间和透视时间为97(四分位距,IQR:80-114)min和8.5(IQR:7.2-9.5)min,分别。在消隐期内的随访期间,共有27名患者(96%)接受了访谈,在4例患者(15%)中记录了早期复发性房颤,包括1例住院期间复发性房颤.未发生重大或次要手术并发症。
    结论:就现实世界的数据而言,我们的数据证实了在持续性房颤患者中使用点阵尖局灶性PFA/RFA导管进行房颤消融的可行性.
    OBJECTIVE: Technological advancements have contributed to the enhanced precision and lesion flexibility in pulsed-field ablation (PFA) by integrating a three-dimensional mapping system combined with a point-by-point ablation strategy. Data regarding the feasibility of this technology remain limited to some clinical trials. This study aims to elucidate initial real-world data on catheter ablation utilizing a lattice-tip focal PFA/radiofrequency ablation (RFA) catheter in patients with persistent atrial fibrillation (AF).
    RESULTS: Consecutive patients who underwent catheter ablation for persistent AF via the lattice-tip PFA/RFA catheter were enrolled. We evaluated acute procedural data including periprocedural data as well as the clinical follow-up within a 90-day blanking period. In total, 28 patients with persistent AF underwent AF ablation either under general anaesthesia (n = 6) or deep sedation (n = 22). In all patients, pulmonary vein isolation was successfully achieved. Additional linear ablations were conducted in 21 patients (78%) with a combination of successful anterior line (n = 13, 46%) and roof line (n = 19, 68%). The median procedural and fluoroscopic times were 97 (interquartile range, IQR: 80-114) min and 8.5 (IQR: 7.2-9.5) min, respectively. A total of 27 patients (96%) were interviewed during the follow-up within the blanking period, and early recurrent AF was documented in four patients (15%) including one case of recurrent AF during the hospital stay. Neither major nor minor procedural complication occurred.
    CONCLUSIONS: In terms of real-world data, our data confirmed AF ablation feasibility utilizing the lattice-tip focal PFA/RFA catheter in patients with persistent AF.
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