An Automated Non-Contact Ultrasound Imaging and Ablation System for the Treatment of Atrial Fibrillation: Outcomes of the First-in-Human VALUE Trial.
- 作者列表："Turagam MK","Petru J","Neuzil P","Kakita K","Kralovec S","Harari D","Phillips P","Piazza D","Whang W","Dukkipati SR","Reddy VY
:Background - Catheter ablation for atrial fibrillation (AF) using point-by-point radiofrequency energy or single-application one-shot balloons is either technically challenging or have limited ability to accommodate variable patient anatomy, respectively. A novel ablation system employs low intensity collimated ultrasound (LICU)-guided anatomical mapping and robotic ablation to isolate pulmonary veins (PVs). In this first-in-human, single-center, multi-operator trial, VALUE (NCT03639597) in paroxysmal AF patients, this LICU system was evaluated to determine its safety, effectiveness in PV isolation (PVI), and freedom from recurrent atrial arrhythmias. Methods - In the enrolled 52 paroxysmal AF patients, ultrasound M-mode-based left atrial anatomies were successfully created, and ablation was performed under robotic control along an operator-defined lesion path. The LICU system software advanced over the course of the study: the last 13 patients were ablated with enhanced software. Results - Acute PVI was achieved in 98% of PVs - using LICU-only in 77.3% (153/198) of PVs, and requiring touch-up with a standard radiofrequency ablation catheter in 22.7% (45/198) PVs. The touch-up rate decreased to 5.8% (3/52) in patients undergoing LICU-ablation with enhanced software. Freedom from atrial arrhythmia recurrence was 79.6% (39/49 patients) at 12-months, or 92.3% (12/13 patients) with the enhanced software. Major adverse events occurred in 3 patients (5.8%): one had transient diaphragmatic paralysis, one vascular access complication, and one had transient ST-segment elevation from air-embolism, without sequelae. Conclusions - In this first-in-human study, low intensity collimated ultrasound-guided anatomical mapping and robotic ablation allows PVI with good chronic safety; PVI success is improving with device enhancements. Clinical Trial Registration - https://clinicaltrials.gov; Unique Identifier: NCT03639597.
: 背景-心房颤动 (AF) 的导管消融使用逐点射频能量或单次应用一次性球囊要么在技术上具有挑战性，要么分别具有有限的适应可变患者解剖结构的能力。一种新型消融系统采用低强度准直超声 (LICU) 引导解剖标测和机器人消融隔离肺静脉 (PVs)。在这项首次在人、单中心、多操作者试验中，VALUE (NCT03639597) 在阵发性 AF 患者中，评估了该 LICU 系统以确定其安全性, PV 隔离 (PVI) 的有效性，无复发性房性心律失常。方法-在入选的 52 例阵发性 AF 患者中，成功创建了基于超声 M 模式的左心房解剖结构，并在机器人控制下沿操作者定义的病变路径进行消融。LICU 系统软件在研究过程中先进: 最后 13 例患者用增强软件消融。结果-98% 的 PVs 实现了急性 PVI-仅使用 LICU-77.3% (153/198) 的 PVs，22.7% (45/198) 需要使用标准射频消融导管进行修补 PVs。在使用增强软件进行 LICU 消融的患者中，修复率降至 5.8% (3/52)。12 个月时房性心律失常复发率为 79.6% (39/49 例患者)，使用增强型软件为 92.3% (12/13 例患者)。3 例患者 (5.8%) 发生主要不良事件: 1 例出现一过性膈肌麻痹，1 例血管通路并发症，1 例出现一过性空气栓塞 ST 段抬高，无后遗症。结论-在这项首次人体研究中，低强度准直超声引导下解剖标测和机器人消融允许 PVI 具有良好的慢性安全性; PVI 的成功正在随着设备的增强而提高。临床试验注册-https://clinicaltrials.gov; 唯一标识符: nct03639597。
METHODS:AIMS:Pulmonary vein isolation (PVI) using ablation index (AI) incorporates stability, contact force (CF), time, and power. The CLOSE protocol combines AI and ≤6 mm interlesion distance. Safety concerns are raised about surround flow ablation catheters (STSF). To compare safety and effectiveness of an atrial fibrillation (AF) ablation strategy using AI vs. CLOSE protocol using STSF.,METHODS AND RESULTS:First cluster was treated using AI and second cluster using CLOSE. Procedural data, safety, and recurrence of any atrial tachycardia (AT) or AF >30 s were collected prospectively. All Classes 1c and III anti-arrhythmic drugs (AAD) were stopped after the blanking period. In total, all 215 consecutive patients [AI: 121 (paroxysmal: n = 97), CLOSE: n = 94 (paroxysmal: n = 74)] were included. Pulmonary vein isolation was reached in all in similar procedure duration (CLOSE: 107 ± 25 vs. AI: 102 ± 24 min; P = 0.1) and similar radiofrequency time (CLOSE: 36 ± 11 vs. AI: 37 ± 8 min; P = 0.4) but first pass isolation was higher in CLOSE vs. AI [left veins: 90% vs. 80%; P < 0.05 and right veins: 84% vs. 73%; P < 0.05]. Twelve-month off-AAD freedom of AF/AT was higher in CLOSE vs. AI [79% (paroxysmal: 85%) vs. 64% (paroxysmal: 68%); P < 0.05]. Only four patients (2%) without recurrence were on AAD during follow-up. Major complications were similar (CLOSE: 2.1% vs. AI: 2.5%; P = 0.87).,CONCLUSION:The CLOSE protocol is more effective than a PVI approach solely using AI, especially in paroxysmal AF. In this off-AAD study, 79% of patients were free from AF/AT during 12-month follow-up. The STSF catheter appears to be safe using conventional CLOSE targets.
METHODS:OBJECTIVE:To investigate the role of driver mechanism and the effect of electrogram dispersion-guided driver mapping and ablation in atrial fibrillation (AF) at different stages of progression.,METHODS:A total of 256 consecutive patients with AF who had undergone pulmonary vein isolation (PVI) plus driver ablation or conventional ablation were divided into three groups: paroxysmal atrial fibrillation (PAF; group A, n = 51); persistent atrial fibrillation (PsAF; group B, n = 38); and long standing-persistent atrial fibrillation (LS-PsAF; group C, n = 39). PVI was performed with the guidance of the ablation index. The electrogram dispersion was analyzed for driver mapping.,RESULTS:The most prominent driver regions were at roof (28.0%), posterior wall (17.6%), and bottom (21.3%). From patients with PAF to those with PsAF and LS-PsAF: the complexity of extra-pulmonary vein (PV) drivers including distribution, mean number, and area of dispersion region increased (P < .001). Patients who underwent driver ablation vs conventional ablation had higher procedural AF termination rate (76.6% vs 28.1%; P < .001). With AF progression, the termination rate gradually decreased from group A to group C, and the role of PVI in AF termination was also gradually weakened from group A to group C (39.6%, 7.4%, and 4.3%; P < .001) in patients with driver ablation. At the end of the follow-up, the rate of sinus rhythm maintenance was higher in patients with driver ablation than those with conventional ablation (89.1% vs 70.3%; P < .001).,CONCLUSION:The formation of extra-PV drivers provides an important mechanism for AF maintenance with their complexity increasing with AF progression. Electrogram dispersion-guided driver ablation appears to be an efficient adjunctive approach to PVI for AF treatment.
METHODS:PURPOSE:Whether or not pulmonary vein isolation (PVI) plus left atrial posterior wall isolation (PWI) using contact force (CF) sensing improves the ablation outcome for persistent atrial fibrillation (AF) is unclear. This study compared the outcome of PVI plus PWI and additional non-PV trigger ablation for persistent AF with/without CF sensing. METHODS:This retrospective cohort study analyzed 148 propensity score-matched persistent AF patients (median duration of persistent AF, 8 months (interquartile range, 3-24 months); left atrial diameter, 43 ± 7 mm) undergoing PVI plus PWI and ablation of non-PV triggers provoked by high-dose isoproterenol, including 74 with CF-sensing catheters (CF group) and 74 with conventional catheters (non-CF group). PVI plus PWI with no additional ablation but cavotricuspid isthmus ablation was performed without non-PV triggers in 48 CF patients (65%) and 54 non-CF patients (73%) (P = 0.38). In all other patients, we performed additional ablation of provoked non-PV triggers. RESULTS:The Kaplan-Meier estimate of the rate of freedom from atrial tachyarrhythmia recurrence of antiarrhythmic drugs at 12 months after the single procedure was higher in the CF group than in the non-CF group (85 vs. 70%, log-rank P = 0.030). A multivariable analysis revealed that using CF sensing and non-inducibility of AF from a non-PV trigger after PVI and PWI were significantly associated with a reduced rate of atrial tachyarrhythmia recurrence. CONCLUSIONS:Compared with non-CF sensing, PVI plus PWI and additional non-PV trigger ablation using CF-sensing catheters for persistent AF can reduce the rate of atrial tachyarrhythmia recurrence.