{"title":"对“50w消融与tactical flex导管用于房颤初始肺静脉隔离的可行性和疗效”的评论。","authors":"Naoto Otsuka MD, PhD, Yasuo Okumura MD, PhD","doi":"10.1002/joa3.13215","DOIUrl":null,"url":null,"abstract":"<p>Radiofrequency (RF) ablation has become an established primary treatment for atrial fibrillation (AF), with pulmonary vein isolation (PVI) as the cornerstone of therapy. Multiple RF ablation catheter options and strategies are available, including high-power short-duration ablation using 50 W output. Recently, an innovative contact force (CF) sensing catheter featuring a mesh-shaped irrigation tip (TactiFlex™ SE, Abbott) has been introduced into clinical practice. However, clinical data remain limited, and the safety and efficacy of this catheter in real-world practice have yet to be fully clarified. In this article,<span><sup>1</sup></span> Matsumoto et al. evaluated the clinical safety and efficacy of the TactiFlex catheter for AF treatment. Their study reported that first-pass PVI was achieved in 82% of right pulmonary veins (RPV) and 87% of left pulmonary veins (LPV) in 100 AF patients, including those with paroxysmal AF (PAF) and non-PAF. Ablation parameters included a CF range of 5–20 g, an ablation duration of 15–20 s, and a fixed power of 50 W. The authors adjusted ablation duration based on impedance measurements; for pre-ablation impedance >120 ohms, the duration was 20 s, while for lower values, it was set at 15 s. The study reported only one gastric hypomotility following left atrial box ablation, with no fatal complications, including steam pops. The authors also identified a cut-off value for impedance drop to achieve first-pass isolation: 13.5 ohms for LPV and 14.5 ohms for RPV. This finding underscores the importance of monitoring impedance drop to achieve effective PVI. A previous study has shown that approximately 80% of steam pops occur when the impedance drop exceeds 18 ohms.<span><sup>2</sup></span> Interestingly, the threshold impedance drop for achieving first-pass isolation in this study (13.5–14.5 ohms) is close to the reported cut-off for preventing steam pops (18 ohms). While the risk of steam pop remains a concern, the TactiFlex catheter appears to have a significantly lower rate of steam pops compared to the SmartTouch Surround Flow (STSF) catheter (1.7% vs. 65.7% at 50 W).<span><sup>3</sup></span> This lower risk is attributed to the catheter's unique mesh-shaped irrigation tip, which enhances irrigation efficiency and reduces the risk of char and thrombus formation. One year after ablation, the AF-free rates were 81.7% in the PAF group and 76.3% in the non-PAF group. Among the 16 patients who experienced AF recurrence, 10 underwent a second ablation session. Of these, two had PV reconnection, five had residual potentials in the carina region without PV reconnection, and three had neither. These results demonstrate the durability of PVI lesions created with the TactiFlex catheter over the long term. Notably, the absence of significant differences in first-pass isolation rates between attending physicians and fellows (RPV: 81.3% vs. 83.3%, <i>p</i> = 0.839; LPV: 93.8% vs. 85.7%, <i>p</i> = 0.381) highlights the catheter's user-friendly design and reliability.</p><p>Compared to the STSF catheter, the TactiFlex catheter produced smaller lesions across all parameters (lesion depth, maximum surface diameter, surface area, lesion volume) when operating at 50 W for 20 s.<span><sup>3</sup></span> Despite the smaller lesion size, the TactiFlex catheter achieved effective transmural ablation, as the mean lesion depth of 3.8 mm was sufficient to penetrate the thin walls of the pulmonary veins and left atrium, which measure approximately 0.88–1.83 mm on computed tomography.<span><sup>4</sup></span> The high PVI durability rates observed at 1 year further confirm the adequacy of these lesions.</p><p>The TactiFlex catheter combines the ability to create effective lesions for durable PVI with enhanced safety, including a reduced risk of steam pops, esophageal injury, and phrenic nerve damage. These advantages are largely attributed to its unique irrigation system and mesh tip design. However, the incidence of severe adverse complications, such as tamponade and stroke, has significantly decreased in recent years, so the number of cases in this study may not be sufficient to draw definitive conclusions. Additionally, the favorable outcomes are based on a single-center study. To further validate these findings, larger case series, including multi-center studies, are needed.</p><p>In conclusion, the TactiFlex catheter offers a promising combination of safety and efficacy for AF ablation, with high rates of first-pass isolation and durable PVI lesions. Its innovative design facilitates consistent results regardless of operator experience, making it a valuable tool in the treatment of AF.</p><p>Dr. Okumura belongs to the endowed departments of Boston Scientific Japan, Biotronik Japan, Abbott Medical Japan, Japan Lifeline, and Medtronic Japan.</p>","PeriodicalId":15174,"journal":{"name":"Journal of Arrhythmia","volume":"41 1","pages":""},"PeriodicalIF":2.2000,"publicationDate":"2025-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751242/pdf/","citationCount":"0","resultStr":"{\"title\":\"Editorial to “Feasibility and efficacy of 50 W ablation with the TactiFlex catheter for the initial pulmonary vein isolation of atrial fibrillation”\",\"authors\":\"Naoto Otsuka MD, PhD, Yasuo Okumura MD, PhD\",\"doi\":\"10.1002/joa3.13215\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p>Radiofrequency (RF) ablation has become an established primary treatment for atrial fibrillation (AF), with pulmonary vein isolation (PVI) as the cornerstone of therapy. Multiple RF ablation catheter options and strategies are available, including high-power short-duration ablation using 50 W output. Recently, an innovative contact force (CF) sensing catheter featuring a mesh-shaped irrigation tip (TactiFlex™ SE, Abbott) has been introduced into clinical practice. However, clinical data remain limited, and the safety and efficacy of this catheter in real-world practice have yet to be fully clarified. In this article,<span><sup>1</sup></span> Matsumoto et al. evaluated the clinical safety and efficacy of the TactiFlex catheter for AF treatment. Their study reported that first-pass PVI was achieved in 82% of right pulmonary veins (RPV) and 87% of left pulmonary veins (LPV) in 100 AF patients, including those with paroxysmal AF (PAF) and non-PAF. Ablation parameters included a CF range of 5–20 g, an ablation duration of 15–20 s, and a fixed power of 50 W. The authors adjusted ablation duration based on impedance measurements; for pre-ablation impedance >120 ohms, the duration was 20 s, while for lower values, it was set at 15 s. The study reported only one gastric hypomotility following left atrial box ablation, with no fatal complications, including steam pops. The authors also identified a cut-off value for impedance drop to achieve first-pass isolation: 13.5 ohms for LPV and 14.5 ohms for RPV. This finding underscores the importance of monitoring impedance drop to achieve effective PVI. A previous study has shown that approximately 80% of steam pops occur when the impedance drop exceeds 18 ohms.<span><sup>2</sup></span> Interestingly, the threshold impedance drop for achieving first-pass isolation in this study (13.5–14.5 ohms) is close to the reported cut-off for preventing steam pops (18 ohms). While the risk of steam pop remains a concern, the TactiFlex catheter appears to have a significantly lower rate of steam pops compared to the SmartTouch Surround Flow (STSF) catheter (1.7% vs. 65.7% at 50 W).<span><sup>3</sup></span> This lower risk is attributed to the catheter's unique mesh-shaped irrigation tip, which enhances irrigation efficiency and reduces the risk of char and thrombus formation. One year after ablation, the AF-free rates were 81.7% in the PAF group and 76.3% in the non-PAF group. Among the 16 patients who experienced AF recurrence, 10 underwent a second ablation session. Of these, two had PV reconnection, five had residual potentials in the carina region without PV reconnection, and three had neither. These results demonstrate the durability of PVI lesions created with the TactiFlex catheter over the long term. Notably, the absence of significant differences in first-pass isolation rates between attending physicians and fellows (RPV: 81.3% vs. 83.3%, <i>p</i> = 0.839; LPV: 93.8% vs. 85.7%, <i>p</i> = 0.381) highlights the catheter's user-friendly design and reliability.</p><p>Compared to the STSF catheter, the TactiFlex catheter produced smaller lesions across all parameters (lesion depth, maximum surface diameter, surface area, lesion volume) when operating at 50 W for 20 s.<span><sup>3</sup></span> Despite the smaller lesion size, the TactiFlex catheter achieved effective transmural ablation, as the mean lesion depth of 3.8 mm was sufficient to penetrate the thin walls of the pulmonary veins and left atrium, which measure approximately 0.88–1.83 mm on computed tomography.<span><sup>4</sup></span> The high PVI durability rates observed at 1 year further confirm the adequacy of these lesions.</p><p>The TactiFlex catheter combines the ability to create effective lesions for durable PVI with enhanced safety, including a reduced risk of steam pops, esophageal injury, and phrenic nerve damage. These advantages are largely attributed to its unique irrigation system and mesh tip design. However, the incidence of severe adverse complications, such as tamponade and stroke, has significantly decreased in recent years, so the number of cases in this study may not be sufficient to draw definitive conclusions. Additionally, the favorable outcomes are based on a single-center study. To further validate these findings, larger case series, including multi-center studies, are needed.</p><p>In conclusion, the TactiFlex catheter offers a promising combination of safety and efficacy for AF ablation, with high rates of first-pass isolation and durable PVI lesions. Its innovative design facilitates consistent results regardless of operator experience, making it a valuable tool in the treatment of AF.</p><p>Dr. Okumura belongs to the endowed departments of Boston Scientific Japan, Biotronik Japan, Abbott Medical Japan, Japan Lifeline, and Medtronic Japan.</p>\",\"PeriodicalId\":15174,\"journal\":{\"name\":\"Journal of Arrhythmia\",\"volume\":\"41 1\",\"pages\":\"\"},\"PeriodicalIF\":2.2000,\"publicationDate\":\"2025-01-21\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751242/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Arrhythmia\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1002/joa3.13215\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Arrhythmia","FirstCategoryId":"1085","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/joa3.13215","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
摘要
射频消融(RF)已成为房颤(AF)的主要治疗方法,肺静脉隔离(PVI)是治疗的基石。多种射频消融导管选择和策略可供选择,包括使用50w输出的高功率短时间消融。最近,一种创新的接触力(CF)传感导管具有网状灌溉尖端(tactical flex™SE,雅培)已被引入临床实践。然而,临床数据仍然有限,该导管在实际应用中的安全性和有效性尚未完全明确。在这篇文章中,1 Matsumoto等人评价了tactical flex导管用于房颤治疗的临床安全性和有效性。他们的研究报告称,在100例房颤患者中,包括阵发性房颤(PAF)和非PAF患者,82%的右肺静脉(RPV)和87%的左肺静脉(LPV)首次通过PVI。烧蚀参数包括:CF范围5-20 g,烧蚀时间15-20 s,固定功率50 W。作者根据阻抗测量调整烧蚀时间;对于预烧蚀阻抗>;120欧姆,持续时间为20秒,对于较低的值,设置为15秒。本研究仅报道一例左心房消融后胃动力低下,无致命并发症,包括蒸汽爆裂。作者还确定了实现首通隔离的阻抗降截止值:LPV为13.5欧姆,RPV为14.5欧姆。这一发现强调了监测阻抗下降以实现有效PVI的重要性。先前的一项研究表明,当阻抗下降超过18欧姆时,大约80%的蒸汽爆裂发生有趣的是,在本研究中实现首通隔离的阈值阻抗降(13.5-14.5欧姆)接近报道的防止蒸汽爆裂的截止值(18欧姆)。虽然蒸汽爆裂的风险仍然是一个问题,但与SmartTouch环绕流(STSF)导管相比,tactical flex导管的蒸汽爆裂率明显较低(在50 W时为1.7% vs. 65.7%)这种较低的风险归因于导管独特的网状灌溉尖端,它提高了灌溉效率,降低了炭和血栓形成的风险。消融1年后,PAF组无af率为81.7%,非PAF组为76.3%。在发生房颤复发的16例患者中,10例接受了第二次消融治疗。其中2例有PV重连,5例在隆突区有剩余电位但无PV重连,3例无。这些结果证明了使用tactical flex导管产生的PVI病变的长期耐久性。值得注意的是,主治医生和研究员的首次隔离率没有显著差异(RPV: 81.3% vs. 83.3%, p = 0.839;LPV: 93.8% vs. 85.7%, p = 0.381)突出了导管的人性化设计和可靠性。与STSF导管相比,在50w下工作20 s时,在所有参数(病变深度、最大表面直径、表面积、病变体积)中,tactical flex导管产生的病变更小尽管病变尺寸较小,但由于平均3.8 mm的病变深度足以穿透肺静脉和左心房的薄壁(计算机断层扫描测量约为0.88-1.83 mm),因此,tactical flex导管实现了有效的跨壁消融1年观察到的高PVI耐久性进一步证实了这些病变的充分性。在增强安全性的同时,为持久的PVI创建有效病变的能力,包括降低蒸汽爆裂、食管损伤和膈神经损伤的风险。这些优点很大程度上归功于其独特的灌溉系统和网头设计。然而,近年来严重不良并发症如填塞和脑卒中的发生率明显下降,因此本研究的病例数可能不足以得出明确的结论。此外,有利的结果是基于单中心研究。为了进一步验证这些发现,需要更大的病例系列,包括多中心研究。总之,在房颤消融中,该导管具有安全性和有效性,具有高的第一次隔离率和持久的PVI病变。其创新的设计使其无论操作人员的经验如何都能获得一致的结果,使其成为治疗af的宝贵工具。Okumura隶属于波士顿科学日本,Biotronik日本,雅培医疗日本,日本生命线和美敦力日本的捐赠部门。
Editorial to “Feasibility and efficacy of 50 W ablation with the TactiFlex catheter for the initial pulmonary vein isolation of atrial fibrillation”
Radiofrequency (RF) ablation has become an established primary treatment for atrial fibrillation (AF), with pulmonary vein isolation (PVI) as the cornerstone of therapy. Multiple RF ablation catheter options and strategies are available, including high-power short-duration ablation using 50 W output. Recently, an innovative contact force (CF) sensing catheter featuring a mesh-shaped irrigation tip (TactiFlex™ SE, Abbott) has been introduced into clinical practice. However, clinical data remain limited, and the safety and efficacy of this catheter in real-world practice have yet to be fully clarified. In this article,1 Matsumoto et al. evaluated the clinical safety and efficacy of the TactiFlex catheter for AF treatment. Their study reported that first-pass PVI was achieved in 82% of right pulmonary veins (RPV) and 87% of left pulmonary veins (LPV) in 100 AF patients, including those with paroxysmal AF (PAF) and non-PAF. Ablation parameters included a CF range of 5–20 g, an ablation duration of 15–20 s, and a fixed power of 50 W. The authors adjusted ablation duration based on impedance measurements; for pre-ablation impedance >120 ohms, the duration was 20 s, while for lower values, it was set at 15 s. The study reported only one gastric hypomotility following left atrial box ablation, with no fatal complications, including steam pops. The authors also identified a cut-off value for impedance drop to achieve first-pass isolation: 13.5 ohms for LPV and 14.5 ohms for RPV. This finding underscores the importance of monitoring impedance drop to achieve effective PVI. A previous study has shown that approximately 80% of steam pops occur when the impedance drop exceeds 18 ohms.2 Interestingly, the threshold impedance drop for achieving first-pass isolation in this study (13.5–14.5 ohms) is close to the reported cut-off for preventing steam pops (18 ohms). While the risk of steam pop remains a concern, the TactiFlex catheter appears to have a significantly lower rate of steam pops compared to the SmartTouch Surround Flow (STSF) catheter (1.7% vs. 65.7% at 50 W).3 This lower risk is attributed to the catheter's unique mesh-shaped irrigation tip, which enhances irrigation efficiency and reduces the risk of char and thrombus formation. One year after ablation, the AF-free rates were 81.7% in the PAF group and 76.3% in the non-PAF group. Among the 16 patients who experienced AF recurrence, 10 underwent a second ablation session. Of these, two had PV reconnection, five had residual potentials in the carina region without PV reconnection, and three had neither. These results demonstrate the durability of PVI lesions created with the TactiFlex catheter over the long term. Notably, the absence of significant differences in first-pass isolation rates between attending physicians and fellows (RPV: 81.3% vs. 83.3%, p = 0.839; LPV: 93.8% vs. 85.7%, p = 0.381) highlights the catheter's user-friendly design and reliability.
Compared to the STSF catheter, the TactiFlex catheter produced smaller lesions across all parameters (lesion depth, maximum surface diameter, surface area, lesion volume) when operating at 50 W for 20 s.3 Despite the smaller lesion size, the TactiFlex catheter achieved effective transmural ablation, as the mean lesion depth of 3.8 mm was sufficient to penetrate the thin walls of the pulmonary veins and left atrium, which measure approximately 0.88–1.83 mm on computed tomography.4 The high PVI durability rates observed at 1 year further confirm the adequacy of these lesions.
The TactiFlex catheter combines the ability to create effective lesions for durable PVI with enhanced safety, including a reduced risk of steam pops, esophageal injury, and phrenic nerve damage. These advantages are largely attributed to its unique irrigation system and mesh tip design. However, the incidence of severe adverse complications, such as tamponade and stroke, has significantly decreased in recent years, so the number of cases in this study may not be sufficient to draw definitive conclusions. Additionally, the favorable outcomes are based on a single-center study. To further validate these findings, larger case series, including multi-center studies, are needed.
In conclusion, the TactiFlex catheter offers a promising combination of safety and efficacy for AF ablation, with high rates of first-pass isolation and durable PVI lesions. Its innovative design facilitates consistent results regardless of operator experience, making it a valuable tool in the treatment of AF.
Dr. Okumura belongs to the endowed departments of Boston Scientific Japan, Biotronik Japan, Abbott Medical Japan, Japan Lifeline, and Medtronic Japan.