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重度症状性主动脉瓣狭窄:药物治疗与经导管主动脉瓣植入术(TAVI)——一项使用国家数据对结局和成本效益进行的真实世界回顾性队列分析

Severe symptomatic aortic stenosis: medical therapy and transcatheter aortic valve implantation (TAVI)-a real-world retrospective cohort analysis of outcomes and cost-effectiveness using national data.

作者信息

Freeman Phillip M, Protty Majd B, Aldalati Omar, Lacey Arron, King William, Anderson Richard A, Smith Dave

机构信息

Division of Population Medicine, Cardiff University, Cardiff, UK; Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.

Division of Population Medicine , Cardiff University , Cardiff , UK.

出版信息

Open Heart. 2016 Jun 8;3(1):e000414. doi: 10.1136/openhrt-2016-000414. eCollection 2016.

DOI:10.1136/openhrt-2016-000414
PMID:27335656
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4908912/
Abstract

OBJECTIVES

Determine the real-world difference between 2 groups of patients with severe aortic stenosis and similar baseline comorbidities: surgical turn down (STD) patients, who were managed medically prior to the availability of transcatheter aortic valve implantation (TAVI) following formal surgical outpatient assessment, and patients managed with a TAVI implant.

DESIGN

Retrospective cohort study from real-world data.

SETTING

Electronic patient letters were searched for patients with a diagnosis of severe aortic stenosis and a formal outpatient STD prior to the availability of TAVI (1999-2009). The second group comprised the first 90 cases of TAVI in South Wales (2009 onwards). 2 years prior to and 5 years following TAVI/STD were assessed. Patient data were pseudoanonymised, using the Secure Anonymized Information Linkage (SAIL) databank, and extracted from Office National Statistics (ONS), Patient-Episode Database for Wales (PEDW) and general practitioner databases.

POPULATION

90 patients who had undergone TAVI in South Wales, and 65 STD patients who were medically managed.

MAIN OUTCOME MEASURES

Survival, hospital admission frequency and length of stay, primary care visits, and cost-effectiveness.

RESULTS

TAVI patients were significantly older (81.8 vs 79.2), more likely to be male (59.1% vs 49.3%), baseline comorbidities were balanced. Mortality in TAVI versus STD was 28% vs 70% at 1000 days follow-up. There were significantly more hospital admissions per year in the TAVI group prior to TAVI/STD (1.5 (IQR 1.0-2.4) vs 1.0 IQR (0.5-1.5)). Post TAVI/STD, the TAVI group had significantly lower hospital admissions (0.3 (IQR 0.0-1.0) vs 1.2 (IQR 0.7-3.0)) and lengths of stay (0.4 (IQR 0.0-13.8) vs 11.0 (IQR 2.5-28.5), p<0.05). The incremental cost-effectiveness ratio (ICER) for TAVI was £10 533 per quality-adjusted life year (QALY).

CONCLUSIONS

TAVI patients were more likely to survive and avoid hospital admissions compared with the medically managed STD group. The ICER for TAVI was £10 533 per QALY, making it a cost-effective procedure.

摘要

目的

确定两组具有相似基线合并症的严重主动脉瓣狭窄患者之间的实际差异:手术拒绝(STD)患者,即在经导管主动脉瓣植入术(TAVI)可用之前,经过正式外科门诊评估后接受药物治疗的患者,以及接受TAVI植入治疗的患者。

设计

基于真实世界数据的回顾性队列研究。

背景

在TAVI可用之前(1999 - 2009年),通过搜索电子患者信件寻找诊断为严重主动脉瓣狭窄且有正式门诊手术拒绝记录的患者。第二组包括南威尔士的首批90例TAVI病例(2009年起)。对TAVI/STD前2年和后5年进行评估。使用安全匿名信息链接(SAIL)数据库对患者数据进行伪匿名处理,并从国家统计局(ONS)、威尔士患者事件数据库(PEDW)和全科医生数据库中提取。

研究对象

90例在南威尔士接受TAVI的患者,以及65例接受药物治疗的STD患者。

主要观察指标

生存率、住院频率和住院时间、初级保健就诊次数以及成本效益。

结果

TAVI组患者年龄显著更大(81.8岁对79.2岁),男性比例更高(59.1%对49.3%),基线合并症情况均衡。在1000天随访时,TAVI组与STD组的死亡率分别为28%和70%。在TAVI/STD之前,TAVI组每年的住院次数显著更多(1.5次(四分位间距1.0 - 2.4)对1.0次(四分位间距0.5 - 1.5))。TAVI/STD之后,TAVI组的住院次数显著更低(0.3次(四分位间距0.0 - 1.0)对1.2次(四分位间距0.7 - 3.0)),住院时间也显著更短(0.4天(四分位间距0.0 - 13.8)对11.0天(四分位间距2.5 - 28.5),p<0.05)。TAVI的增量成本效益比(ICER)为每质量调整生命年(QALY)10533英镑。

结论

与接受药物治疗的STD组相比,TAVI组患者更有可能存活并避免住院。TAVI的ICER为每QALY 10533英镑,使其成为一种具有成本效益的治疗方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aa17/4908912/5697cd3e5e6b/openhrt2016000414f05.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aa17/4908912/0f034c0752d7/openhrt2016000414f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aa17/4908912/d87a5dab3972/openhrt2016000414f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aa17/4908912/7449ad12a6e3/openhrt2016000414f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aa17/4908912/7e37dcb9b725/openhrt2016000414f04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aa17/4908912/5697cd3e5e6b/openhrt2016000414f05.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aa17/4908912/0f034c0752d7/openhrt2016000414f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aa17/4908912/d87a5dab3972/openhrt2016000414f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aa17/4908912/7449ad12a6e3/openhrt2016000414f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aa17/4908912/7e37dcb9b725/openhrt2016000414f04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aa17/4908912/5697cd3e5e6b/openhrt2016000414f05.jpg

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