Brignole M, Gianfranchi L, Menozzi C, Alboni P, Musso G, Bongiorni M G, Gasparini M, Raviele A, Lolli G, Paparella N, Acquarone S
Section of Arrhythmology, Ospedali Riuniti, Lavagna, Italy.
Circulation. 1997 Oct 21;96(8):2617-24. doi: 10.1161/01.cir.96.8.2617.
The purpose of the study was to evaluate the effect of AV junction ablation and pacemaker implantation on quality of life and specific symptoms in patients with paroxysmal atrial fibrillation (AF) not controlled by drugs.
We performed a multicenter, randomized, 6-month evaluation of the clinical effects of AV junction ablation and DDDR mode-switching pacemaker (Abl+Pm) versus pharmacological treatment in 43 patients with intolerable, recurrent paroxysmal AF of three or more episodes in the previous 6 months not controlled with three or more antiarrhythmic drugs. Before completion of the study, 3 patients in the drug group withdrew because of the severity of their symptoms and 1 patient assigned to the Abl+Pm group in whom the ablation procedure failed. At the end of the 6 months, the 21 patients of the Abl+Pm group who completed the study showed, in comparison with the 18 of the drug group, lower scores in the Living with Heart Failure Questionnaire (-51%, P=.0006), palpitations (-71%, P=.0000), effort dyspnea (-36%, P=.04), exercise intolerance score (-46%, P=.001), and easy fatigue (-51%, P=.02). The scores for rest dyspnea, chest discomfort, and NYHA functional classification were also lower (-56%, -50%, and -17%, respectively) in the Abl+Pm group, although not significantly. At the end of the study, palpitations were no longer present in 81% of the Abl+Pm group and in 11% of the drug group (P=.0000). AF was documented in 31 of 122 visits (25%) in the Abl+Pm group and in 9 of 107 examinations (8%) in the drug group (P=.0005); chronic AF developed in 5 (24%) and 0 (0%) in the two groups, respectively (P=.04).
In patients with paroxysmal AF not controlled by pharmacological therapy, Abl+Pm treatment is highly effective and superior to drug therapy in controlling symptoms and improving quality of life. The discontinuation of drug therapy exposes patients to further recurrences of paroxysmal AF and the risk of developing permanent AF.
本研究旨在评估房室结消融术和起搏器植入术对阵发性心房颤动（房颤）患者生活质量及特定症状的影响，这些患者的房颤症状无法通过药物控制。
我们对43例患者进行了一项多中心、随机、为期6个月的评估，比较房室结消融术和DDDR模式转换起搏器（消融+起搏器）与药物治疗的临床效果。这些患者在前6个月内有3次或更多次无法耐受的复发性阵发性房颤发作，且使用3种或更多种抗心律失常药物均无法控制。在研究完成前，药物治疗组有3例患者因症状严重而退出，消融+起搏器组有1例患者消融手术失败。6个月结束时，完成研究的消融+起搏器组的21例患者与药物治疗组的18例患者相比，在心力衰竭生活问卷中的得分更低（-51%，P = 0.0006），心悸症状（-71%，P = 0.0000）、劳力性呼吸困难（-36%，P = 0.04）、运动不耐受评分（-46%，P = 0.001）和易疲劳症状（-51%，P = 0.02）均有所改善。消融+起搏器组的静息呼吸困难、胸部不适和纽约心脏协会功能分级得分也较低（分别为-56%、-50%和-17%），尽管差异不显著。研究结束时，消融+起搏器组81%的患者心悸症状消失，而药物治疗组这一比例为11%（P = 0.0000）。消融+起搏器组122次就诊中有31次记录到房颤（25%），药物治疗组107次检查中有9次记录到房颤（8%）（P = 0.0005）；两组分别有5例（24%）和0例（0%）发展为慢性房颤（P = 0.04）。
对于药物治疗无法控制的阵发性房颤患者，消融+起搏器治疗在控制症状和改善生活质量方面非常有效且优于药物治疗。停用药物治疗会使患者面临阵发性房颤进一步复发以及发展为永久性房颤的风险。
