Thoracoscopic Ablation With Appendage Ligation Versus Medical Therapy for Stroke Prevention: A Proof-of-Concept Randomized Trial.
Thoracoscopic Ablation With Appendage Ligation Versus Medical Therapy for Stroke Prevention: A Proof-of-Concept Randomized Trial.
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DOI：
10.1097/imi.0000000000000226
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发表时间：
2016-03
期刊：
影响因子：
--
通讯作者：
Waters MF
中科院分区：
文献类型：
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作者：
Beaver TM;Hedna VS;Khanna AY;Miles WM;Price CC;Schmalfuss IM;Aalaei-Andabili SH;Waters MF
房颤（AF）对生活质量（QOL）有明显影响。10%的房颤患者发生复发性卒中。本研究的目的是证明胸腔镜肺静脉隔离和心耳结扎（TPVIAL）可以预防复发性卒中，并可能改善既往卒中房颤患者的生活质量。该研究是美国国立卫生研究院资助的单中心概念验证设计，将23例AF相关卒中患者随机分为TPVIAL组（n = 12）或药物治疗组（n = 11）。生活质量是主要结果变量，次要终点包括心律恢复、卒中复发和手术发病率。TPVIAL组3个月和6个月时的生活质量子评分显示能量改善和疲劳减轻[基线，33（19.8）; 3个月，49.5（20.6），P = 0.01; 6个月，55.5（14.4），P = 0.03]。在12个月随访时，TPVIAL组没有复发性卒中。在药物治疗组中，6个月时有2例患者（P = 0.22）和12个月时共有3例患者（P = 0.09）复发缺血性卒中。药物治疗组有1例死亡，TPVIAL组阵发性房颤患者无房颤复发，1例持续性和长期性房颤复发，TPVIAL组7例患者停止华法林治疗以预防二级卒中。这项小型概念验证研究表明，TPVIAL改善了两个分项评分的QOL，并恢复了除1例患者外的所有患者的正常窦性心律，并显示了预防继发性卒中的潜力。需要进行更大规模的研究。
Atrial fibrillation (AF) has a demonstrable effect on quality of life (QOL). Recurrent stroke occurs in 10% of patients with AF. The objective of this study was to demonstrate proof of concept that thoracoscopic pulmonary vein isolation and atrial appendage ligation (TPVIAL) could prevent recurrent stroke and could potentially improve QOL in patients with AF with a previous stroke. The study was a National Institutes of HealthYfunded single-center proof-of-concept design that randomized 23 patients with AF-related stroke to TPVIAL (n = 12) or to medical management (n = 11). Quality of life was the primary outcome variable; secondary end points included restoration of rhythm, recurrent stroke, and surgical morbidity. Quality-of-life subscores at 3 and 6 months revealed improvements in energy and decreases in fatigue in the TPVIAL arm [baseline, 33 (19.8); 3 months, 49.5 (20.6), P = 0.01; 6 months, 55.5 (14.4), P = 0.03]. At 12-month follow-up, there were no recurrent strokes in the TPVIAL group. In the medically treated arm, two patients at 6 months (P = 0.22) and three total patients at 12 months (P = 0.09) had recurrent ischemic stroke. There was one death in the medical management arm. In the TPVIAL arm, no AF recurrence occurred in patients with paroxysmal AF, and one patient had recurrence of persistent and long-standing AF. Seven patients in the TPVIAL arm discontinued warfarin therapy for secondary stroke prevention. This small proof-of-concept study showed that TPVIAL improved QOL on two subscores and restored normal sinus rhythm in all but one patient, and it showed the potential to prevent secondary stroke. A larger study will be needed.