用于长期持续性心房颤动的混合心外膜-心内膜消融术：CONVERGE试验的亚组分析
Hybrid epicardial-endocardial ablation for long-standing persistent atrial fibrillation: A subanalysis of the CONVERGE Trial.
作者信息
DeLurgio David B, Blauth Christopher, Halkos Michael E, Crossen Karl J, Talton David, Oza Saumil R, Magnano Anthony R, Mostovych Mark A, Billakanty Sreedhar, Duff Steven, Stees Christopher, Sperling Jason, Ahsan Syed, Yap John, Shults Christian, Pederson David, Garrison James, Tabereaux Paul, Gilligan David M, Bundy Graham, Costantini Otto, Espinal Eric, La Pietra Angelo, Yang Felix, Greenberg Yisachar, Jacobowitz Israel, Gill Jaswinder
机构信息
St. Joseph's Hospital, Emory University, Atlanta, Georgia.
Guy's and St. Thomas' Foundation Trust, London, United Kingdom.
出版信息
Heart Rhythm O2. 2022 Dec 5;4(2):111-118. doi: 10.1016/j.hroo.2022.11.007. eCollection 2023 Feb.
BACKGROUND
Favorable clinical outcomes are difficult to achieve in long-standing persistent atrial fibrillation (LSPAF) with catheter ablation (CA). The CONVERGE (Convergence of Epicardial and Endocardial Ablation for the Treatment of Symptomatic Persistent Atrial FIbrillation) trial evaluated the effectiveness of hybrid convergent (HC) ablation vs endocardial CA.
OBJECTIVE
The study sought to evaluate the safety and effectiveness of HC vs CA in the LSPAF subgroup from the CONVERGE trial.
METHODS
The CONVERGE trial was a prospective, multicenter, randomized trial that enrolled 153 patients at 27 sites. A post hoc analysis was performed on LSPAF patients. The primary effectiveness was freedom from atrial arrhythmias off new or increased dose of previously failed or intolerant antiarrhythmic drugs (AADs) through 12 months. The primary safety endpoint was major adverse event incidence through 30 days with HC. Key secondary effectiveness measures included (1) percent of patients achieving ≥90% AF burden reduction vs baseline and (2) AF freedom.
RESULTS
Sixty-five patients (42.5% of total enrollment) had LSPAF; 38 in HC and 27 in CA. Primary effectiveness was 65.8% (95% confidence interval [CI] 50.7%-80.9%) with HC vs 37.0% (95% CI 5.1%-52.4%) with CA ( .022). Through 18 months, these rates were 60.5% (95% CI 50.0%-76.1%) with HC vs 25.9% (95% CI 9.4%-42.5%) with CA ( .006). Secondary effectiveness rates were higher than CA with HC at 12 and 18 months. Freedom from atrial arrhythmias off AADs was 52.6% (95% CI 36.8%-68.5%) and 47.4% (95% CI 31.5%-63.2%) with HC at 12 and 18 months vs 25.9% (95% CI 9.4%-42.5%) and 22.2% (95% CI 6.5%-37.9%) with CA, respectively (12 months: .031; 18 months: .038). Three (7.9%) major adverse events occurred within 30 days of HC.
CONCLUSION
Post hoc analysis demonstrated effectiveness and acceptable safety of HC compared with CA in LSPAF.
背景
对于长期持续性心房颤动（LSPAF）患者，导管消融（CA）难以取得良好的临床疗效。CONVERGE（心外膜与心内膜消融治疗症状性持续性心房颤动的融合）试验评估了杂交消融（HC）与心内膜CA的有效性。
目的
本研究旨在评估CONVERGE试验中LSPAF亚组患者接受HC与CA治疗的安全性和有效性。
方法
CONVERGE试验是一项前瞻性、多中心、随机试验，在27个地点招募了153例患者。对LSPAF患者进行事后分析。主要有效性指标是在12个月内不使用新的或增加剂量的先前无效或不耐受的抗心律失常药物（AAD）时无房性心律失常。主要安全性终点是HC治疗30天内的主要不良事件发生率。关键的次要有效性指标包括：（1）与基线相比房颤负荷降低≥90%的患者百分比；（2）无房颤。
结果
65例患者（占总入组人数的42.5%）患有LSPAF；HC组38例，CA组27例。HC组的主要有效性为65.8%（95%置信区间[CI]50.7%-80.9%），CA组为37.0%（95%CI 5.1%-52.4%）（P = 0.022）。至18个月时，HC组为60.5%（95%CI 50.0%-76.1%），CA组为25.9%（95%CI 9.4%-42.5%）（P = 0.006）。12个月和18个月时，HC组的次要有效性率高于CA组。不使用AAD时无房性心律失常的比例，HC组在12个月和18个月时分别为52.6%（95%CI 36.8%-68.5%）和47.4%（95%CI 31.5%-63.2%），CA组分别为25.9%（95%CI 9.4%-42.5%）和22.2%（95%CI 6.5%-37.9%）（12个月：P = 0.031；18个月：P = 0.038）。HC治疗30天内发生了3例（7.9%）主要不良事件。
结论
事后分析表明，在LSPAF患者中，与CA相比，HC具有有效性且安全性可接受。
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