Goyal Sandeep K, Pappone Carlo, Grimaldi Massimo, Lee Sung W, Mountantonakis Stavros, DeVille J Brian, Sagi Venkata S, Jiang Chen-Yang, Jafri Haseeb, Wimmer Alan P, Wu Li-Qun, Dukkipati Srinivas, Rashid Haroon, Calkins Hugh, Mansour Moussa, Roman-Gonzalez Javier, Natale Andrea, Ciconte Giuseppe, Aryana Arash
Division of Cardiac Electrophysiology, Piedmont Heart Institute, Atlanta, Georgia, USA.
Department of Arrhythmology, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy.
J Cardiovasc Electrophysiol. 2025 Feb;36(2):376-386. doi: 10.1111/jce.16524. Epub 2024 Dec 16.
The safety and efficacy of paroxysmal atrial fibrillation (PAF) ablation with the HELIOSTAR multielectrode radiofrequency (RF) balloon catheter have been demonstrated in European studies; data from elsewhere are lacking. This prospective, multicenter study conducted in the United States, Italy, and China investigated the safety and efficacy of pulmonary vein isolation (PVI) using HELIOSTAR in drug-refractory symptomatic PAF.
The primary effectiveness endpoint (PEE) was 12-month freedom from documented atrial fibrillation/atrial flutter/atrial tachycardia plus freedom from acute procedural failure, nonstudy catheter failure, repeat ablation failure, direct current cardioversion (DCCV), and Class I/III antiarrhythmic drug (AAD) failure. The primary safety endpoint was the occurrence of early-onset primary adverse events (PAEs). Cerebral magnetic resonance imaging (MRI) and cardiac computed tomography were performed in a patient subset to assess silent cerebral lesions (SCLs) and severe pulmonary vein (PV) stenosis, respectively.
Across 36 centers, 257 eligible subjects in the main phase had the study catheter inserted. Acute PVI was achieved in all subjects, with the majority (94.1%) using the balloon catheter only. In 67.7% and 92.2% of subjects, respectively, PEE and freedom from repeat ablation were met; clinical success rate was 77.7%. The PAE rate was 5.1%. One of 15 (6.7%) subjects with MRI showed a new SCL at 1 month postablation, which resolved at 3 months. Clinically meaningful improvements in Atrial Fibrillation Effect on QualiTy-of-life scores were seen at 3 months and were sustained to 12 months postablation, and accompanied with reduction of Class I/III AAD use and DCCV.
STELLAR confirmed the safety and efficacy of the HELIOSTAR catheter for PVI, with clinically meaningful improvements in quality of life in patients with drug-refractory symptomatic PAF. Most PVIs were achieved without focal touch-up, and > 90% of patients were free from repeat ablation at 12 months.
ClinicalTrials.gov Identifier: NCT03683030.
在欧洲的研究中已证实使用HELIOSTAR多电极射频（RF）球囊导管进行阵发性心房颤动（PAF）消融的安全性和有效性；其他地区的数据尚缺。这项在美国、意大利和中国开展的前瞻性多中心研究调查了使用HELIOSTAR进行肺静脉隔离（PVI）治疗药物难治性症状性PAF的安全性和有效性。
主要有效性终点（PEE）为12个月无记录的心房颤动/心房扑动/房性心动过速，且无急性手术失败、非研究导管失败、重复消融失败、直流电复律（DCCV）以及I/III类抗心律失常药物（AAD）治疗失败。主要安全性终点是早期原发性不良事件（PAE）的发生。对部分患者进行了脑磁共振成像（MRI）和心脏计算机断层扫描，分别评估无症状性脑损伤（SCL）和严重肺静脉（PV）狭窄。
在36个中心，主要阶段有257名符合条件的受试者插入了研究导管。所有受试者均成功实现急性PVI，大多数（94.1%）仅使用球囊导管。分别有67.7%和92.2%的受试者达到PEE且无需重复消融；临床成功率为77.7%。PAE发生率为5.1%。15名接受MRI检查的受试者中有1名（6.7%）在消融后1个月出现新的SCL，3个月时消失。在消融后3个月时，房颤对生活质量评分有临床意义的改善，并持续至消融后12个月，同时I/III类AAD的使用和DCCV减少。
STELLAR证实了HELIOSTAR导管用于PVI的安全性和有效性，对药物难治性症状性PAF患者的生活质量有临床意义的改善。大多数PVI无需局部补点即可实现，超过90%的患者在12个月时无需重复消融。
ClinicalTrials.gov标识符：NCT03683030。
