杂交融合手术治疗后房颤症状减轻及生活质量改善：一项CONVERGE试验的亚分析
Atrial fibrillation symptom reduction and improved quality of life following the hybrid convergent procedure: a CONVERGE trial subanalysis.
作者信息
Gill Jaswinder, Crossen Karl J, Blauth Christopher, Kerendi Faraz, Oza Saumil R, Magnano Anthony R, Mostovych Mark A, Halkos Michael E, Tschopp David, Osorio Jose, Tabereaux Paul, Boedefeld William, Civello Kenneth, Ahsan Syed, Yap John, Billakanty Sreedhar, Duff Steve, Costantini Otto, Espinal Eric, Kiser Andy, Shults Christian, Pederson David, Garrison James, Gilligan David M, Link Michael G, Kowalski Marcin, Stees Christopher, Sperling Jason S, Jacobowitz Israel, Yang Felix, Greenberg Yisachar J, De Lurgio David B
机构信息
Guy's and St Thomas' Foundation Trust, London, UK.
North Mississippi Health Services, Tupelo, MS, USA.
出版信息
Ann Cardiothorac Surg. 2024 Mar 29;13(2):155-164. doi: 10.21037/acs-2023-afm-15. Epub 2023 Aug 29.
BACKGROUND
CONVERGE was a prospective, multicenter, randomized controlled trial that evaluated the safety of Hybrid Atrial Fibrillation Convergent (HC) and compared its effectiveness to endocardial catheter ablation (CA) for the treatment of persistent atrial fibrillation (PersAF) and longstanding PersAF (LSPAF). In 2020, we reported that CONVERGE met its primary safety and effectiveness endpoints. The primary objective of the present study is to report CONVERGE trial results for quality of life (QOL) and Class I/III anti-arrhythmic drug (AAD) utilization following HC.
METHODS
Eligible patients had drug-refractory symptomatic PersAF or LSPAF and a left atrium diameter ≤6.0 cm. Enrolled patients were randomized 2:1 to receive HC or CA. Atrial Fibrillation Severity Scale (AFSS) and the 36-Item Short Form Health Survey (SF-36) were assessed at baseline and 12 months; statistical comparison was performed using paired -tests. AAD utilization at baseline through 12 and 18 months post-procedure was evaluated; statistical comparison was performed using McNemar's tests.
RESULTS
A total of 153 patients were treated with either HC (n=102) or CA (n=51). Of the 102 HC patients, 38 had LSPAF. AFSS and SF-36 Mental and Physical Component scores were significantly improved at 12 months versus baseline with HC overall and for the subset of LSPAF patients treated with either HC or CA. The proportion of HC patients (n=102) who used Class I /III AADs at 12 and 18 months was significantly less (33.3% and 36.3%, respectively) than baseline (84.3%; P<0.001). In LSPAF patients who underwent HC (n=38), AADs use was 29.0% through 18 months follow-up versus 71.1% at baseline (P<0.001).
CONCLUSIONS
HC reduced AF symptoms, significantly improved QOL, and reduced AAD use in patients with PersAF and LSPAF.
CLINICALTRIALSGOV IDENTIFIER
NCT01984346.
背景
CONVERGE是一项前瞻性、多中心、随机对照试验，评估了混合性心房颤动融合术（HC）的安全性，并将其有效性与心内膜导管消融术（CA）治疗持续性心房颤动（PersAF）和长期持续性心房颤动（LSPAF）进行比较。2020年，我们报告CONVERGE达到了其主要安全性和有效性终点。本研究的主要目的是报告CONVERGE试验中HC治疗后生活质量（QOL）和I/III类抗心律失常药物（AAD）使用情况的结果。
方法
符合条件的患者患有药物难治性症状性PersAF或LSPAF，且左心房直径≤6.0 cm。入选患者按2:1随机分组接受HC或CA治疗。在基线和12个月时评估心房颤动严重程度量表（AFSS）和36项简短健康调查（SF-36）；使用配对t检验进行统计学比较。评估基线至术后12个月和18个月的AAD使用情况；使用McNemar检验进行统计学比较。
结果
共有153例患者接受了HC（n = 102）或CA（n = 51）治疗。在102例HC患者中，38例患有LSPAF。总体而言，HC治疗组以及接受HC或CA治疗的LSPAF患者亚组在12个月时的AFSS和SF-36心理和身体成分评分与基线相比均有显著改善。HC患者（n = 102）在12个月和18个月时使用I/III类AAD的比例显著低于基线（分别为33.3%和36.3%，而基线为84.3%；P<0.001）。在接受HC治疗的LSPAF患者（n = 38）中，随访18个月期间AAD的使用率为29.0%，而基线时为71.1%（P<0.001）。
结论
HC减轻了AF症状，显著改善了QOL，并减少了PersAF和LSPAF患者的AAD使用。
临床试验注册编号
NCT01984346。
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