Radioablation

放射消融
  • 文章类型: Journal Article
    当前的立体定向心律失常(STAR)工作流程的一部分是从电解剖标测(EAM)到计算机断层扫描(CT)的结果转移。这里,我们使用旨在产生更高鲁棒性的自动配准算法,分析了改进的EAM-CT配准中的观察者间和观察者内变化.
    这项工作基于10位先前接受STAR的患者的数据。两名观察员参加了这项研究:(1)在EAM-CT合并方面具有实质性经验的电生理学家(心脏病学),(2)EAM-CT合并经验最少的临床工程师(放疗)。EAM-CT合并包括3个主要步骤:从CT分割左心室(CTLV),CTLV和EAM的配准,从EAM特定点划分临床目标体积(CTV)。平均豪斯多夫距离(MHD),使用骰子相似系数(DSC)和重心绝对差(CoG)来评估观察者内/观察者间的变异性。
    观察者内变异性:3个CTLV的平均DSC和MHD为0.92±0.01和1.49±0.23mm。3个CTV的平均DSC和MHD为0.82±0.06和0.71±0.22mm。观察者间变异性:分段CTLV显示出极大的相似性(平均DSC为0.91±0.01,MHD为1,86±0.47mm)。比较来自两个观察者的CTV的平均DSC为0.81±0.11,MHD为0.87±0.45mm。
    分段的LV和划定的CTV的高观察者间相似性证实了所提出方法的鲁棒性。即使没有经验的用户也可以按照工作流程指令执行精确的EAM-CT合并。
    UNASSIGNED: Part of the current stereotactic arrythmia radioablation (STAR) workflow is transfer of findings from the electroanatomic mapping (EAM) to computed tomography (CT). Here, we analyzed inter- and intraobserver variation in a modified EAM-CT registration using automatic registration algorithms designed to yield higher robustness.
    UNASSIGNED: This work is based on data of 10 patients who had previously undergone STAR. Two observers participated in this study: (1) an electrophysiologist technician (cardiology) with substatial experience in EAM-CT merge, and (2) a clinical engineer (radiotherapy) with minimum experience with EAM-CT merge. EAM-CT merge consists of 3 main steps: segmentation of left ventricle from CT (CT LV), registration of the CT LV and EAM, clinical target volume (CTV) delineation from EAM specific points. Mean Hausdorff distance (MHD), Dice Similarity Coefficient (DSC) and absolute difference in Center of Gravity (CoG) were used to assess intra/interobserver variability.
    UNASSIGNED: Intraobserver variability: The mean DSC and MHD for 3 CT LVs altogether was 0.92 ± 0.01 and 1.49 ± 0.23 mm. The mean DSC and MHD for 3 CTVs altogether was 0,82 ± 0,06 and 0,71 ± 0,22 mm. Interobserver variability: Segmented CT LVs showed great similarity (mean DSC of 0,91 ± 0,01, MHD of 1,86 ± 0,47 mm). The mean DSC comparing CTVs from both observers was 0,81 ± 0,11 and MHD was 0,87 ± 0,45 mm.
    UNASSIGNED: The high interobserver similarity of segmented LVs and delineated CTVs confirmed the robustness of the proposed method. Even an inexperienced user can perform a precise EAM-CT merge following workflow instructions.
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  • 文章类型: Journal Article
    目的:临床前数据表明,使用质子微型束放射疗法可降低健康组织的毒性风险。室性心动过速放射消融是质子束治疗的临床研究领域。我们试图用质子微型束模拟室性心动过速放射性消融,并证明使用这种技术可以获得致心律失常心脏区的均匀覆盖。
    方法:在患者的模拟CT扫描中定义了致心律失常的目标体积,位于左心室的侧壁。计划通过质子小束放射治疗输送25Gy的剂量,使用蒙特卡罗代码(TOPASv.3.7)进行模拟,准直器具有19个0.4mm宽的狭缝,间隔3mm。研究的主要目的是获得一个计划,确保在计划目标体积的93%中至少有93%的处方剂量,而不超过计划目标体积中规定剂量的110%。
    结果:质子小束放射治疗计划治疗体积的平均剂量为25.12Gy。计划目标卷接收93%的百分比(V93%),110%(V110%),处方剂量的95%(V95%)为94.25%,0%,分别为92.6%。外侧半影为6.6mm。计划目标体积中的峰谷剂量比的平均值为1.06。立体定向光子束照射的平均心脏剂量为2.54Gy,与5.95Gy相比。
    结论:这项概念验证研究表明,质子微型束放射治疗可以实现致心律失常心脏区的均匀覆盖,减少正常组织的剂量。这项技术,确保理论上可以降低晚期肺纤维化和乳腺纤维化的风险,以及在质子微型束放射疗法的先前生物学研究中看到的心脏毒性。
    OBJECTIVE: Preclinical data demonstrated that the use of proton minibeam radiotherapy reduces the risk of toxicity in healthy tissue. Ventricular tachycardia radioablation is an area under clinical investigation in proton beam therapy. We sought to simulate a ventricular tachycardia radioablation with proton minibeams and to demonstrate that it was possible to obtain a homogeneous coverage of an arrhythmogenic cardiac zone with this technique.
    METHODS: An arrhythmogenic target volume was defined on the simulation CT scan of a patient, localized in the lateral wall of the left ventricle. A dose of 25Gy was planned to be delivered by proton minibeam radiotherapy, simulated using a Monte Carlo code (TOPAS v.3.7) with a collimator of 19 0.4 mm-wide slits spaced 3mm apart. The main objective of the study was to obtain a plan ensuring at least 93% of the prescription dose in 93% of the planning target volume without exceeding 110% of the prescribed dose in the planning target volume.
    RESULTS: The average dose in the planning treatment volume in proton minibeam radiotherapy was 25.12Gy. The percentage of the planning target volume receiving 93% (V93%), 110% (V110%), and 95% (V95%) of the prescribed dose was 94.25%, 0%, and 92.6% respectively. The lateral penumbra was 6.6mm. The mean value of the peak-to-valley-dose ratio in the planning target volume was 1.06. The mean heart dose was 2.54Gy versus 5.95Gy with stereotactic photon beam irradiation.
    CONCLUSIONS: This proof-of-concept study shows that proton minibeam radiotherapy can achieve a homogeneous coverage of an arrhythmogenic cardiac zone, reducing the dose at the normal tissues. This technique, ensuring could theoretically reduce the risk of late pulmonary and breast fibrosis, as well as cardiac toxicity as seen in previous biological studies in proton minibeam radiotherapy.
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  • 文章类型: Journal Article
    静脉曲张是一种常见的血管疾病,已知会引起不适和美容问题。这篇全面的叙事回顾深入研究了他们的解剖学,病理生理学,和现代治疗选择,专注于静脉内技术和硬化治疗。该综述首先强调下肢静脉循环的复杂解剖结构,强调浅静脉和深静脉网络在静脉回流中的重要性。它还解决了静脉壁的变化,包括瓣膜功能不全,有助于静脉曲张的发展。静脉内技术,如腔内激光消融(EVLA),射频消融(RFA),并对机械化学腔内消融(MOCA)进行了详细探讨。这些微创手术彻底改变了静脉曲张治疗,与传统手术相比,具有较高的成功率和较快的恢复速度。审查还强调了它们的功效和安全性,帮助临床医生做出明智的决策。硬化疗法,静脉曲张的重要形态,被彻底检查,覆盖液体和泡沫硬化疗法。泡沫硬化疗法,特别是,因其改进的结果而得到认可。该综述提供了这些治疗方式的全面比较,突出技术成功的差异,复发率,和成本效益。患者的偏好和满意度在选择正确的治疗中起着重要作用。探讨了与这些治疗相关的安全性和潜在并发症,重点关注次要问题和罕见不良事件。这篇综述还强调了静脉曲张干预对患者生活质量的积极影响。
    Varicose veins are a common vascular condition known for causing discomfort and cosmetic concerns. This comprehensive narrative review delves into their anatomy, pathophysiology, and modern treatment options, with a focus on endovenous techniques and sclerotherapy. The review starts by emphasizing the intricate anatomy of lower extremity venous circulation, underlining the significance of both superficial and deep venous networks in venous return. It also addresses how changes in the venous wall, including valvular insufficiency, contribute to the development of varicose veins. Endovenous techniques like endovenous laser ablation (EVLA), radiofrequency ablation (RFA), and mechanochemical endovenous ablation (MOCA) are explored in detail. These minimally invasive procedures have revolutionized varicose vein treatment, offering high success rates and quicker recovery compared to traditional surgery. The review also highlights their efficacy and safety profiles, aiding clinicians in informed decision-making. Sclerotherapy, a vital modality for varicose veins, is thoroughly examined, covering both liquid and foam sclerotherapy. Foam sclerotherapy, in particular, is recognized for its improved outcomes. The review provides a comprehensive comparison of these treatment modalities, highlighting differences in technical success, recurrence rates, and cost-effectiveness. Patient preferences and satisfaction play a significant role in choosing the right treatment. Safety and potential complications associated with these treatments are explored, with a focus on minor issues and rare adverse events. This review also emphasizes the positive impact of varicose vein interventions on patients\' quality of life.
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  • 文章类型: Journal Article
    目前,室性心动过速(VT)和室颤(VF)的标准治疗方法是射频导管消融.然而,当VT电路在心肌深处时,导管可能无法输送,一个新的,需要使用不同能量的微创治疗。
    这是一项可行性研究的协议文件,旨在为至少一次导管消融后未通过导管消融治愈的难治性室性心动过速提供立体定向放射治疗。主要终点是评估该治疗的短期安全性,次要终点是通过减少VT发作来评估其疗效。射波刀M6放射外科系统将用于治疗,和规定的剂量的目标将是25Gy在一个部分。该研究将对三名患者进行。
    由于导管消融是在日本保险范围内的室性心动过速的唯一治疗选择,目前尚无其他无法通过导管消融治愈的VT/VF治疗方法.我们希望这项可行性研究将为目前处于ICD激活压力下的患者提供希望。
    该研究已在日本临床试验注册中心(jRCTs042230030)注册。
    Currently, the standard curative treatment for ventricular tachycardia (VT) and ventricular fibrillation (VF) is radiofrequency catheter ablation. However, when the VT circuit is deep in the myocardium, the catheter may not be delivered, and a new, minimally invasive treatment using different energies is desired.
    This is a protocol paper for a feasibility study designed to provide stereotactic radiotherapy for refractory VT not cured by catheter ablation after at least one catheter ablation. The primary end point is to evaluate the short-term safety of this treatment and the secondary endpoint is to evaluate its efficacy as assessed by the reduction in VT episode. Cyberknife M6 radiosurgery system will be used for treatment, and the prescribed dose to the target will be 25Gy in one fraction. The study will be conducted on three patients.
    Since catheter ablation is the only treatment option for VT that is covered by insurance in Japan, there is currently no other treatment for VT/VF that cannot be cured by catheter ablation. We hope that this feasibility study will provide hope for patients who are currently under the stress of ICD activation.
    The study has been registered in the Japan Registry of Clinical Trials (jRCTs042230030).
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  • 文章类型: Journal Article
    使用心脏立体定向身体放射治疗(放射消融)治疗难治性室性心律失常的患者是患有晚期结构性心脏病和严重合并症的患者。然而,有关手术后1年死亡率的数据很少.这项系统评价和汇总分析旨在确定心脏射频消融治疗难治性室性心律失常后1年的死亡率,并调查该人群的主要死亡原因。截至2023年1月,在MEDLINE/EMBASE数据库中搜索了包括接受心脏放射消融治疗难治性室性心律失常患者在内的研究。使用NIH病例系列研究工具(PROSPEROCRD42022379713)评估纳入试验的质量。共检索并评估了1,151个参考文献的相关性。数据来自16项研究,共有157例患者因难治性室性心律失常而接受心脏放射消融术。合并1年死亡率为32%(95CI:23-41),几乎一半的死亡发生在治疗后的三个月内。在157名患者中,46人在心脏射频消融后一年内死亡。恶化的心力衰竭似乎是死亡的主要原因(52%),尽管该人群的非心脏死亡率仍然很高(41%).年龄≥70岁与显著较高的12个月全因死亡率相关(p<0.022)。目标体积大小和放射治疗装置均未显示与1年死亡率相关(分别为p=0.465和p=0.199)。接受心脏立体定向身体放射治疗的难治性室性心律失常的患者中约有三分之一在手术后的第一年内死亡。恶化的心力衰竭似乎是该人群死亡的主要原因。
    Patients treated with cardiac stereotactic body radiation therapy (radioablation) for refractory ventricular arrhythmias are patients with advanced structural heart disease and significant comorbidities. However, data regarding 1-year mortality after the procedure are scarce. This systematic review and pooled analysis aimed at determining 1-year mortality after cardiac radioablation for refractory ventricular arrhythmias and investigating leading causes of death in this population. MEDLINE/EMBASE databases were searched up to January 2023 for studies including patients undergoing cardiac radioablation for the treatment of refractory ventricular arrhythmias. Quality of included trials was assessed using the NIH Tool for Case Series Studies (PROSPERO CRD42022379713). A total of 1,151 references were retrieved and evaluated for relevance. Data were extracted from 16 studies, with a total of 157 patients undergoing cardiac radioablation for refractory ventricular arrhythmias. Pooled 1-year mortality was 32 % (95 %CI: 23-41), with almost half of the deaths occurring within three months after treatment. Among the 157 patients, 46 died within the year following cardiac radioablation. Worsening heart failure appeared to be the leading cause of death (52 %), although non-cardiac mortality remained substantial (41 %) in this population. Age≥70yo was associated with a significantly higher 12-month all-cause mortality (p<0.022). Neither target volume size nor radiotherapy device appeared to be associated with 1-year mortality (p = 0.465 and p = 0.199, respectively). About one-third of patients undergoing cardiac stereotactic body radiation therapy for refractory ventricular arrhythmias die within the first year after the procedure. Worsening heart failure appears to be the leading cause of death in this population.
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  • 文章类型: Journal Article
    心律失常,包括室性心动过速(VT),对健康构成重大威胁,常导致死亡和心源性猝死。虽然室性心动过速的常规治疗方法表现出疗效,难治性VT的病例构成了挑战。立体定向心律失常放射消融(STAR)提供了一种新的方法,以最小的附带损害向明确定义的目标提供精确的高剂量辐射。这项研究探讨了STAR作为替代疗法的潜力,特别是对于高危患者或难治性VT患者。
    本研究回顾了正在进行的研究和对STAR疗效和安全性评估的初步调查。该方法涉及靶向放射递送,评估难治性VT患者VT复发的减少和早期安全性。然而,考虑到STAR的早期阶段和有限的临床证据,建议谨慎解释。
    初步发现表明STAR可减少室性心动过速复发,建议承诺作为一种治疗选择。早期的安全状况令人鼓舞,但关于疗效和安全性的明确陈述需要进一步调查.积极的初步结果强调需要更多的数据和长期研究。
    立体定向心律失常放射性消融术是最近出现的一种治疗难治性室性心动过速的有前景的治疗方法。虽然早期结果令人鼓舞,需要仔细的解释,由于明星的早期阶段。持续的调查对于全面了解其长期疗效和耐受性至关重要。这篇评论提供了对STAR背景的基本见解,原则,预处理程序,临床意义,和毒性,为这个不断发展的治疗领域的未来研究奠定了基础。
    UNASSIGNED: Cardiac arrhythmias, including ventricular tachycardia (VT), stand as a significant threat to health, often leading to mortality and sudden cardiac death. While conventional treatments for VT exhibit efficacy, cases of refractory VT pose challenges. Stereotactic Arrhythmia Radioablation (STAR) offers a novel approach, delivering precise high-dose radiation to well-defined targets with minimal collateral damage. This study explores the potential of STAR as an alternative therapy, especially for high-risk patients or those with refractory VT.
    UNASSIGNED: This research reviews ongoing studies and preliminary investigations into the evaluation of the efficacy and safety of STAR. The method involves targeted radiation delivery, assessing reductions in VT recurrence and the early safety profile in refractory VT patients. However, given STAR\'s early stage and limited clinical evidence, cautious interpretation is advised.
    UNASSIGNED: Preliminary findings indicate a reduction in VT recurrence with STAR, suggesting promise as a therapeutic option. Early safety profiles are encouraging, but definitive statements on efficacy and safety require further investigation. Positive initial outcomes underscore the need for additional data and long-term studies.
    UNASSIGNED: Stereotactic Arrhythmia Radioablation is recently emerging as a promising treatment for refractory VT. While early results are encouraging, careful interpretation is needed, due to STAR\'s early stages. Ongoing investigations are critical for a comprehensive understanding of its long-term efficacy and tolerability. This review provides fundamental insights into STAR\'s background, principles, pre-treatment procedures, clinical implications, and toxicity, setting the stage for future research in this evolving therapeutic field.
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  • 文章类型: Journal Article
    室性心动过速(VT)是一种重要的心律失常,有猝死的风险。虽然植入式心脏除颤和射频消融与室性心动过速的药物治疗一起使用,在没有反应的情况下,治疗选择是有限的。在耐药病例中应用于VT基质的立体定向消融体放射治疗(SABR)是一种新兴的治疗方法,效果良好。这样的临床结果增加了对该受试者的兴趣。然而,尚未描述用于该疗法的理想治疗装置和方法,这通常使用各种设备和方法在单个部分应用。在这里,在一个中心使用VarianTrueBeamEDGE和TomoTherapyRadixact设备对总共8例患者(11例室性心动过速基质)进行治疗计划。并对结果进行了剂量比较。统计分析采用Wilcoxon符号秩检验。平均值表示为中位数和四分位距(IQRs)。在体积调制电弧治疗(VMAT)和螺旋断层治疗(HT)计划中,计划覆盖范围和合规指数相似;同时,同质性指数分别为0.10(IQR=0.05)和0.07(IQR=0.05),分别,并且在HT计划中明显更好(p=0.02)。在VMAT和HT计划中,梯度指数分别为3.18(IQR=0.8)和5.33(IQR=3.68),分别,并且在VMAT计划中明显更好。对于处于危险中的器官,观察到相似的剂量。在VMAT计划中,胃和食道的最大剂量以及左肺和双肺的平均剂量明显较低。同样,在VMAT计划中,心脏亚结构和大血管的最大和平均剂量显著较低.在HT中获得了更多的均匀计划,而在VMAT中观察到更快的剂量减少和更低的临界器官剂量。两种技术都可以获得合理的心肌SABR计划。剂量学差异对临床结果的影响应在前瞻性临床研究中进行评估。
    Ventricular tachycardia (VT) is an important type of arrhythmia with a risk of sudden death. Although implanted cardiac defibrillation and radiofrequency ablation are used together with medical treatments for VT, the treatment options are limited in cases that do not respond to them. Stereotactic ablative body radiotherapy (SABR) applied to VT substrates in resistant cases is an emerging treatment with positive results. Such clinical results have increased the interest in this subject. However, the ideal treatment device and method have not yet been described for this therapy, which is generally applied at a single fraction using various devices and methods. Herein, treatment planning was conducted for a total of 8 patients (11 VT substrates) using the Varian TrueBeam EDGE and TomoTherapy Radixact devices at a single center, and the results were compared dosimetrically. The Wilcoxon-signed rank test was used for the statistical analysis, and mean values were expressed as medians and interquartile ranges (IQRs). In the volumetric modulated arc therapy (VMAT) and helical tomotherapy (HT) plans, the plan coverages and conformity indexes were similar; meanwhile, the homogeneity indexes were 0.10 (IQR = 0.05) and 0.07 (IQR = 0.05), respectively, and were significantly better in the HT plan (p = 0.02). The gradient indexes were 3.18 (IQR = 0.8) and 5.33 (IQR = 3.68) in the VMAT and HT plans, respectively, and were significantly better in the VMAT plan. For the organs at risk, similar doses were observed. The maximum doses for the stomach and esophagus and the mean doses for the left lung and both lungs were significantly lower in the VMAT plan. Similarly, the maximum and mean doses for the cardiac substructures and great vessels were significantly lower in the VMAT plan. More homogeneous plans were obtained in HT, while a faster dose reduction and lower critical organ dose were observed in VMAT. Reasonable myocardial SABR plans could be obtained with both techniques. The effects of the dosimetric differences on the clinical outcomes should be evaluated in prospective clinical studies.
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  • 文章类型: Journal Article
    这篇叙述性文献综述的目的是收集和分析已发表的立体定向心律失常放射消融(STAR)治疗难治性心律失常的临床前研究的结果。在PubMed上使用以下术语进行文献检索:(\"立体定向\"或\"SBRT\"或\"SABR\"或\"放射消融\"或\"放射外科\")和(\"心律失常\"或\"心动过速\")。临床前和病理报告以英文发表,没有时间限制,包括STAR在动物模型中的研究以及外植动物和人类心脏的组织学分析。分析的研究证实,低于25Gy的剂量似乎会产生次优的治疗结果,而>35Gy的剂量在辐射诱导的毒性方面安全性较低。然而,长期结果(>1年)仍然缺失,并报告基于低剂量照射(≤15Gy)的结果.最后,尽管对不同的心脏靶标进行了辐照,但在分析的研究中,STAR被证明是一种有效的治疗方法。因此,需要进一步的研究来:1)比较25Gy和30Gy剂量的STAR的结局;2)评估与临床相似剂量照射的动物模型的长期结果(>1年);3)确定最佳目标.
    The aim of this narrative review of the literature was to collect and analyze the results of the published preclinical studies on stereotactic arrhythmia radioablation (STAR) in the treatment of refractory cardiac arrhythmias. A literature search was conducted on PubMed using the following terms: (\"stereotactic\" OR \"SBRT\" OR \"SABR\" OR \"radioablation\" OR \"radiosurgery\") AND (\"arrhythmia\" OR \"tachycardia\"). Preclinical and pathological reports published in English without time limit, comprising studies of STAR in animal models and histological analyzes of explanted animal and human hearts were included. The analyzed studies confirm that doses lower than 25 Gy seem to produce sub-optimal therapeutic results whereas doses >35 Gy are less safe in terms of radiation-induced toxicity. However, long-term results (>1 year) are still missing and reporting outcomes based on low dose irradiation (≤15 Gy). Finally, STAR proved to be an effective therapy in the analyzed studies despite the irradiation of rather different cardiac targets. Therefore, additional studies are needed to: 1) compare the outcomes of STAR at doses of 25 Gy versus 30 Gy; 2) evaluate the long-term results (>1 year) in animal models irradiated at doses similar to those used in the clinic; 3) define the optimal target.
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  • 文章类型: Journal Article
    UNASSIGNED:单形性室性心动过速(VT)是一种威胁生命的疾病,通常在结构性心脏病患者中观察到。通过放射治疗(VT-ART)进行室性心动过速消融治疗持续性单形性室性心动过速似乎很有希望。有效,和安全。VT-ART提供聚焦,高剂量辐射,通常是25Gy的一小部分,通过诱导心肌疤痕来进行室性心动过速消融。该程序是完全非侵入性的;因此,对于有侵入性消融手术禁忌症的患者,可以很容易地进行。缺乏明确的数据,和标准程序没有直接比较是可用的。
    UNASSIGNED:这项多中心观察性研究的目的是评估VT-ART的疗效和安全性,比较接受VT-ART的患者与未接受此类手术的患者的临床结局.两组不会直接收集,前瞻性应计以避免在创新和传统领域中进行随机化:通过配对分析的回顾性选择将收集具有与联盟内(在每个中心独立)接受VT-ART的患者相似的特征的患者。我们的试验将纳入优化药物治疗的患者,其中心内膜和/或心外膜射频消融(RFA),室性心动过速消融的黄金标准,要么不可行,要么无法控制VT复发。我们的主要结果是调查接受VT-ART的组和未接受创新程序的组之间总体心血管生存率的差异。次要结果是评估最后一次手术后无心室事件生存率的差异(即,上一次RFAvs.VT-ART)在两组之间。另一个次要目的是评估室性心动过速发作次数的减少,将手术前3个月与室性心动过速ART和RFA后6个月(第4个月至第6个月)记录的室性心动过速发作次数进行比较,分别。其他次要目标包括确定VT-ART对心脏功能的益处,通过心电图评估,超声心动图,生化变量,以及患者的生活质量。我们计算了149名患者的样本量(以2:1的比例):非暴露对照组100名,VT-ART组49名。逐步,在VT-ART联盟促进中心的多中心监督下,对于每个VT-ART患者登记,根据预定义特征的配对患者档案将与联盟共享,以纳入未接受VT-ART的患者.
    UNASSIGNED:我们的试验将通过配对分析深入了解VT-ART的疗效和安全性,通过观测,在多中心联盟中对两组有或没有VT-ART的患者进行多中心研究(将亚组分层为动态队列)。
    UNASSIGNED: Monomorphic ventricular tachycardia (VT) is a life-threatening condition often observed in patients with structural heart disease. Ventricular tachycardia ablation through radiation therapy (VT-ART) for sustained monomorphic ventricular tachycardia seems promising, effective, and safe. VT-ART delivers focused, high-dose radiation, usually in a single fraction of 25 Gy, allowing ablation of VT by inducing myocardial scars. The procedure is fully non-invasive; therefore, it can be easily performed in patients with contraindications to invasive ablation procedures. Definitive data are lacking, and no direct comparison with standard procedures is available.
    UNASSIGNED: The aim of this multicenter observational study is to evaluate the efficacy and safety of VT-ART, comparing the clinical outcome of patients undergone to VT-ART to patients not having received such a procedure. The two groups will not be collected by direct, prospective accrual to avoid randomization among the innovative and traditional arm: A retrospective selection through matched pair analysis will collect patients presenting features similar to the ones undergone VT-ART within the consortium (in each center independently). Our trial will enroll patients with optimized medical therapy in whom endocardial and/or epicardial radiofrequency ablation (RFA), the gold standard for VT ablation, is either unfeasible or fails to control VT recurrence. Our primary outcome is investigating the difference in overall cardiovascular survival among the group undergoing VT-ART and the one not exposed to the innovative procedure. The secondary outcome is evaluating the difference in ventricular event-free survival after the last procedure (i.e., last RFA vs. VT-ART) between the two groups. An additional secondary aim is to evaluate the reduction in the number of VT episodes comparing the 3 months before the procedure to the ones recorded at 6 months (from the 4th to 6th month) following VT-ART and RFA, respectively. Other secondary objectives include identifying the benefits of VT-ART on cardiac function, as evaluated through an electrocardiogram, echocardiographic, biochemical variables, and on patient quality of life. We calculated the sample size (in a 2:1 ratio) upon enrolling 149 patients: 100 in the non-exposed control group and 49 in the VT-ART group. Progressively, on a multicentric basis supervised by the promoting center in the VT-ART consortium, for each VT-ART patient enrollment, a matched pair patient profile according to the predefined features will be shared with the consortium to enroll a patient that has not undergone VT-ART.
    UNASSIGNED: Our trial will provide insight into the efficacy and safety of VT-ART through a matched pair analysis, via an observational, multicentric study of two groups of patients with or without VT-ART in the multicentric consortium (with subgroup stratification into dynamic cohorts).
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  • 文章类型: Editorial
    暂无摘要。
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