虽然大型随机临床试验发现,一级预防使用植入式心律转复除颤器(ICD)可改善心肌病和心力衰竭症状患者的生存率,与纳入临床试验的患者相比,在实践中接受ICD的患者通常年龄较大,并且有更多的合并症.此外,临床医师对电生理研究对无症状Brugada综合征患者的危险分层是否有用存在争议.
我们的分析有两个目标。首先,评估程序电刺激在无症状的Brugada综合征患者中诱导的室性心律失常(VA)是否确定了可能需要额外检测或治疗的较高风险人群.第二,评估ICD的植入是否与老年患者和有合并症的患者的临床获益相关,否则这些患者会根据左心室射血分数和心力衰竭症状获益.
传统的统计方法用于解决:1)程序心室刺激是否在无症状的Brugada综合征患者中识别出高风险人群;2)用于一级预防的ICD植入是否与老年患者(>75岁)和有明显合并症的患者的预后改善相关,否则根据症状或左心室功能符合ICD植入标准。
确定了来自6项研究的1138名无症状患者的证据。在电生理研究中,在390名(34.3%)患者中发现了具有诱导型VA的Brugada综合征。为了尽量减少病人重叠,主要分析使用6项研究中的5项,发现主要心律失常事件的比值比为2.3(95%CI:0.63-8.66;P=0.2)(持续的VAs,心源性猝死,或适当的ICD治疗)在电生理研究中,无症状的Brugada综合征和诱导型VA患者与没有诱导型VA的患者相比。回顾了10项评估老年患者ICD使用的研究,并确定了4项评估独特患者群体的研究。在我们的分析中,ICD植入与生存改善相关(总风险比:0.75;95%置信区间:0.67-0.83;P<0.001)。确定了十项研究,评估了包括肾脏疾病在内的各种合并症患者的ICD使用情况。慢性阻塞性肺疾病,心房颤动,心脏病,和其他人。随机效应模型表明,使用ICD与降低全因死亡率相关(总体风险比:0.72;95%置信区间:0.65-0.79;P<0.0001),第二次"最小重叠"分析还发现使用ICD与降低全因死亡率相关(总体风险比:0.71;95%置信区间:0.61-0.82;P<0.0001).在包括肾功能不全数据的5项研究中,ICD植入与全因死亡率降低相关(总体风险比:0.71;95%置信区间:0.60-0.85;P<0.001)。
Although large randomized clinical trials have found that primary prevention use of an implantable cardioverter-defibrillator (ICD) improves survival in patients with cardiomyopathy and heart failure symptoms, patients who receive ICDs in practice are often older and have more comorbidities than patients who were enrolled in the clinical trials. In addition, there is a debate among clinicians on the usefulness of electrophysiological study for risk stratification of asymptomatic patients with Brugada syndrome.
Our analysis has 2 objectives. First, to evaluate whether ventricular arrhythmias (VAs) induced with programmed electrostimulation in asymptomatic patients with Brugada syndrome identify a higher risk group that may require additional testing or therapies. Second, to evaluate whether implantation of an ICD is associated with a clinical benefit in older patients and patients with comorbidities who would otherwise benefit on the basis of left ventricular ejection fraction and heart failure symptoms.
Traditional statistical approaches were used to address 1) whether programmed ventricular stimulation identifies a higher-risk group in asymptomatic patients with Brugada syndrome and 2) whether ICD implantation for primary prevention is associated with improved outcomes in older patients (>75 years of age) and patients with significant comorbidities who would otherwise meet criteria for ICD implantation on the basis of symptoms or left ventricular function.
Evidence from 6 studies of 1138 asymptomatic patients were identified. Brugada syndrome with inducible VA on electrophysiological study was identified in 390 (34.3%) patients. To minimize patient overlap, the primary analysis used 5 of the 6 studies and found an odds ratio of 2.3 (95% CI: 0.63-8.66; P=0.2) for major arrhythmic events (sustained VAs, sudden cardiac death, or appropriate ICD therapy) in asymptomatic patients with Brugada syndrome and inducible VA on electrophysiological study versus those without inducible VA. Ten studies were reviewed that evaluated ICD use in older patients and 4 studies that evaluated unique patient populations were identified. In our analysis, ICD implantation was associated with improved survival (overall hazard ratio: 0.75; 95% confidence interval: 0.67-0.83; P<0.001). Ten studies were identified that evaluated ICD use in patients with various comorbidities including renal disease, chronic obstructive pulmonary disease, atrial fibrillation, heart disease, and others. A random effects model demonstrated that ICD use was associated with reduced all-cause mortality (overall hazard ratio: 0.72; 95% confidence interval: 0.65-0.79; P<0.0001), and a second \"minimal overlap\" analysis also found that ICD use was associated with reduced all-cause mortality (overall hazard ratio: 0.71; 95% confidence interval: 0.61-0.82; P<0.0001). In 5 studies that included data on renal dysfunction, ICD implantation was associated with reduced all-cause mortality (overall hazard ratio: 0.71; 95% confidence interval: 0.60-0.85; P<0.001).