School of Nursing, McMaster University, Hamilton, Ontario, Canada.
Division of Cardiology, St. Michael's Hospital, Toronto, Ontario, Canada.
BMJ Open. 2017 Aug 21;7(8):e017577. doi: 10.1136/bmjopen-2017-017577.
Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia and causes patients considerable burden; symptoms such as palpitations and dyspnoea are common, leading to frequent emergency room visits. Patients with AF report reduced health-related quality of life (HQOL) compared with the general population; thus, treatments focus on the restoration of sinus rhythm to improve symptoms. Catheter ablation (CA) is a primary treatment strategy to treat AF-related burden in select patient populations; however, repeat procedures are often needed, there is a risk of major complications and the procedure is quite costly in comparison to medical therapy. As the outcomes after CA are mixed, an updated review that synthesises the available literature, on outcomes that matter to patients, is needed so that patients and their healthcare providers can make quality treatment decisions. The purpose of this review protocol is to extend previous findings by systematically analysing randomised controlled trials (RCTs) of CA in patients with AF and using meta-analytic techniques to identify the benefits and risks of CA with respect to HQOL and AF-related symptoms.
We will include all RCTs that compare CA with antiarrhythmic drugs, or radiofrequency CA with cryoballoon CA, in patients with paroxysmal or persistent AF. To locate studies we will perform comprehensive electronic database searches from database inception to 4 April 2017, with no language restrictions. We will conduct a quantitative synthesis of the effect of CA on HQOL as well as AF-related symptoms and the number of CA procedures needed for success, using meta-analytic techniques.
No ethical issues are foreseen and ethical approval is not required given that this is a protocol. The findings of the study will be reported at national and international conferences, and in a peer-reviewed journal using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.
In accordance with the guidelines, our systematic review protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) on 6 March 2017 and was last updated on 6 March 2017 (registration number CRD42017057427).
Any protocol amendments will be documented on the International Prospective Register of Systematic Reviews (PROSPERO) and in the final manuscript and indicated as such.
心房颤动(AF)是最常见的心律失常,给患者带来了相当大的负担;常见的症状包括心悸和呼吸困难,导致频繁急诊就诊。与一般人群相比,AF 患者报告的健康相关生活质量(HQOL)降低;因此,治疗重点是恢复窦性节律以改善症状。导管消融(CA)是治疗特定患者人群中 AF 相关负担的主要治疗策略;然而,通常需要重复进行该程序,存在发生重大并发症的风险,并且与药物治疗相比,该程序的费用相当高。由于 CA 的结果参差不齐,因此需要对综合现有文献的最新综述进行更新,以了解对患者重要的结果,以便患者及其医疗保健提供者能够做出优质的治疗决策。本综述方案的目的是通过系统分析 AF 患者的 CA 随机对照试验(RCT),并使用荟萃分析技术,确定 CA 在 HQOL 和 AF 相关症状方面的获益和风险,从而扩展先前的发现。
我们将纳入所有比较阵发性或持续性 AF 患者中 CA 与抗心律失常药物或射频 CA 与冷冻球囊 CA 的 RCT。为了定位研究,我们将从数据库创建开始到 2017 年 4 月 4 日进行全面的电子数据库搜索,不限制语言。我们将使用荟萃分析技术,对 CA 对 HQOL 以及 AF 相关症状的影响以及成功所需的 CA 程序数量进行定量综合。
由于这是一项方案,因此预计不会出现伦理问题,也不需要获得伦理批准。研究结果将在国家和国际会议上以及使用系统评价和荟萃分析的首选报告项目(PRISMA)指南的同行评审期刊上报告。
根据指南,我们的系统评价方案于 2017 年 3 月 6 日在国际前瞻性系统评价注册库(PROSPERO)中注册,并于 2017 年 3 月 6 日进行了最后更新(注册号 CRD42017057427)。
任何方案修正案都将记录在国际前瞻性系统评价注册库(PROSPERO)和最终手稿中,并加以说明。