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新发心房颤动患者的超声心动图:系统评价和经济评估。

Echocardiography in newly diagnosed atrial fibrillation patients: a systematic review and economic evaluation.

机构信息

School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.

出版信息

Health Technol Assess. 2013 Aug;17(36):1-263, v-vi. doi: 10.3310/hta17360.

Abstract

OBJECTIVE

To investigate the clinical effectiveness and cost-effectiveness of transthoracic echocardiography (TTE) in all patients who are newly diagnosed with atrial fibrillation (AF).

DESIGN

Narrative synthesis reviews were conducted on the prognostic and diagnostic accuracy of TTE for, and prevalence of, pathologies in patients with AF. Databases were searched from inception. MEDLINE searches were conducted from March to August 2010, and reference lists of articles checked. There were 44 diagnostic accuracy studies, five prognostic studies, and 16 prevalence studies accepted into the review. Given the complexity of the many pathologies identified by TTE, the variety of potential changes to clinical management, and paucity of data, the model focused on changes to oral anticoagulation (OAC). The mathematical model assessed the cost-effectiveness of TTE for patients with AF who were not routinely given OAC, assuming, if left atrial abnormality was detected, that the higher risk of stroke warranted OAC; this meant that patients with a CHADS2 (cardiac failure, hypertension, age, diabetes, stroke doubled) score of 0 [dabigatran etexilate (Pradaxa, Boehringer Ingelheim)/rivaroxaban (Xarelto, Bayer Schering)] or 0/1 (warfarin) were included. A simplified approach evaluated the additional quality-adjusted life-years (QALYs) required in order for TTE to be perceived as cost-effective at a threshold of £20,000 per QALY.

SETTING

Transthoracic echocardiography is usually performed in cardiology clinics but may be used in primary or non-specialist secondary care.

PARTICIPANTS

Patients with newly diagnosed AF.

INTERVENTION

Transthoracic echocardiography.

MAIN OUTCOME MEASURES

Prognosis, diagnostic sensitivity or specificity of TTE, prevalence of pathologies in patients with AF, cost-effectiveness and QALYs.

RESULTS

Prognostic studies indicated that TTE-diagnosed left ventricular dysfunction, increased left atrial diameter and valvular abnormality were significantly associated with an increased risk of stroke, mortality or thromboembolism. There was a high prevalence (around 25-30%) of ischaemic heart disease, valvular heart disease and heart failure in patients with AF. Diagnostic accuracy of TTE was high, with most pathologies having specificity of ≥ 0.8 and sensitivity of ≥ 0.6. The mathematical model predicted that when the CHADS2 tool is used the addition of TTE in identifying patients with left atrial abnormality appears to be cost-effective for informing some OAC decisions. In the simplified approach a threshold of 0.0033 was required for a TTE to be cost-effective.

CONCLUSIONS

When CHADS2 was used, the addition of TTE in identifying patients with left atrial abnormality was cost-effective for informing some OAC decisions. A simple analysis indicates that the number of QALYs required for TTE to be cost-effective is small, and that if benefits beyond those associated with a reduction in stroke are believed probable then TTE is likely to be cost-effective in all scenarios. Our findings suggest that further research would be useful, following up newly diagnosed patients with AF who have undergone TTE, to study treatments given as a result of TTE diagnoses and subsequent cardiovascular events. This could identify additional benefits of routine testing, beyond stroke prevention. Studies assessing the proportion of people with a CHADS2 score of 0 or 1 that have left atrial abnormality would provide better estimates of the cost-effectiveness of TTE, and allow more accurate estimates of the sensitivity and specificity of TTE for identifying left atrial abnormality in AF to be obtained.

STUDY REGISTRATION

PROSPERO CRD42011001354.

FUNDING

The National Institute for Health Research Health Technology Assessment programme.

摘要

目的

研究经胸超声心动图(TTE)在新发心房颤动(AF)患者中的临床疗效和成本效益。

设计

对 TTE 对 AF 患者的预后和诊断准确性以及病理患病率进行了叙述性综合评价。从成立之初就开始进行数据库搜索。2010 年 3 月至 8 月进行了 MEDLINE 搜索,并检查了文章的参考文献列表。共有 44 项诊断准确性研究、5 项预后研究和 16 项患病率研究被纳入综述。鉴于 TTE 识别的许多病理情况的复杂性、潜在改变临床管理的多样性以及数据的缺乏,该模型主要关注口服抗凝治疗(OAC)的改变。该数学模型评估了 TTE 对未常规给予 OAC 的 AF 患者的成本效益,如果发现左心房异常,则意味着更高的中风风险需要 OAC;这意味着 CHADS2(心力衰竭、高血压、年龄、糖尿病、中风加倍)评分为 0 [达比加群酯(Pradaxa,勃林格殷格翰)/利伐沙班(Xarelto,拜耳先灵]或 0/1(华法林)的患者。一种简化方法评估了 TTE 需要额外的质量调整生命年(QALYs),以便在每 QALY 20,000 英镑的阈值下被认为具有成本效益。

设置

TTE 通常在心脏病学诊所进行,但也可在初级或非专科二级保健中使用。

参与者

新诊断为 AF 的患者。

干预措施

经胸超声心动图。

主要观察指标

预后、TTE 的诊断敏感性或特异性、AF 患者的病理患病率、成本效益和 QALYs。

结果

预后研究表明,TTE 诊断的左心室功能障碍、左心房直径增大和瓣膜异常与中风、死亡率或血栓栓塞风险增加显著相关。AF 患者中缺血性心脏病、瓣膜性心脏病和心力衰竭的患病率约为 25-30%。TTE 的诊断准确性较高,大多数病理情况的特异性≥0.8,敏感性≥0.6。该数学模型预测,当使用 CHADS2 工具时,在识别具有左心房异常的患者中添加 TTE 似乎可以为一些 OAC 决策提供信息,具有成本效益。在简化方法中,TTE 要具有成本效益,需要达到 0.0033 的阈值。

结论

当使用 CHADS2 时,在识别具有左心房异常的患者中添加 TTE 对于一些 OAC 决策具有成本效益。简单分析表明,TTE 具有成本效益所需的 QALYs 数量较少,如果认为除了降低中风之外还有可能带来其他益处,则 TTE 在所有情况下都可能具有成本效益。我们的研究结果表明,需要进行进一步的研究,对接受 TTE 检查的新发 AF 患者进行随访,研究 TTE 诊断后的治疗方法以及随后的心血管事件。这可以确定常规检测除了预防中风之外的其他益处。评估 CHADS2 评分为 0 或 1 的人群中左心房异常的比例将提供 TTE 成本效益的更好估计,并可以获得 TTE 对 AF 中左心房异常的诊断准确性和特异性的更准确估计。

研究注册

PROSPERO CRD42011001354。

资金来源

英国国家卫生研究院卫生技术评估计划。

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