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真实世界证据在国民保健服务中的应用:英国 CardioMEMS HF 系统上市后研究结果。

Real-world evidence in a national health service: results of the UK CardioMEMS HF System Post-Market Study.

机构信息

Royal Brompton Hospital (Guy's and St Thomas' NHS Foundation Trust), Sydney Street, London, SW3 6NP, UK.

University Hospital Southampton, Southampton, UK.

出版信息

ESC Heart Fail. 2022 Feb;9(1):48-56. doi: 10.1002/ehf2.13748. Epub 2021 Dec 9.

Abstract

AIMS

The CardioMEMS HF System Post-Market Study (COAST) was designed to evaluate the safety, effectiveness, and feasibility of haemodynamic-guided heart failure (HF) management using a small sensor implanted in the pulmonary artery of New York Heart Association (NYHA) Class III HF patients in the UK, Europe, and Australia.

METHODS AND RESULTS

COAST is a prospective, international, multicentre, open-label clinical study (NCT02954341). The primary clinical endpoint compares annualized HF hospitalization rates after 1 year of haemodynamic-guided management vs. the year prior to sensor implantation in patients with NYHA Class III symptoms and a previous HF hospitalization. The primary safety endpoints assess freedom from device/system-related complications and pressure sensor failure after 2 years. Results from the first 100 patients implanted at 14 out of the 15 participating centres in the UK are reported here. At baseline, all patients were in NYHA Class III, 70% were male, mean age was 69 ± 12 years, and 39% had an aetiology of ischaemic cardiomyopathy. The annualized HF hospitalization rate after 12 months was 82% lower [95% confidence interval 72-88%] than the previous 12 months (0.27 vs. 1.52 events/patient-year, respectively, P < 0.0001). Freedom from device/system-related complications and pressure sensor failure at 2 years was 100% and 99%, respectively.

CONCLUSIONS

Remote haemodynamic-guided HF management, using frequent assessment of pulmonary artery pressures, was successfully implemented at 14 specialist centres in the UK. Haemodynamic-guided HF management was safe and significantly reduced hospitalization in a group of high-risk patients. These results support implementation of this innovative remote management strategy to improve outcome for patients with symptomatic HF. Clinical registration number: ClinicalTrials.gov identifier: NCT02954341.

摘要

目的

CardioMEMS HF 系统上市后研究(COAST)旨在评估使用植入肺动脉的小型传感器对英国、欧洲和澳大利亚纽约心脏协会(NYHA)III 级心力衰竭(HF)患者进行血液动力学指导 HF 管理的安全性、有效性和可行性。

方法和结果

COAST 是一项前瞻性、国际、多中心、开放性临床研究(NCT02954341)。主要临床终点比较 1 年后血液动力学指导管理的年化 HF 住院率与传感器植入前 1 年的年化 HF 住院率在 NYHA III 级症状和既往 HF 住院的患者中。主要安全性终点评估 2 年后设备/系统相关并发症和压力传感器故障的无发生率。这里报告了在英国 15 个参与中心中的 14 个中心植入的前 100 名患者的结果。基线时,所有患者均为 NYHA III 级,70%为男性,平均年龄为 69±12 岁,39%有缺血性心肌病的病因。12 个月后的年化 HF 住院率降低了 82%[95%置信区间为 72-88%](分别为 0.27 次/患者年和 1.52 次/患者年,P<0.0001)。2 年时设备/系统相关并发症和压力传感器故障的无发生率分别为 100%和 99%。

结论

在英国的 14 个专业中心成功实施了频繁评估肺动脉压力的远程血液动力学指导 HF 管理。血液动力学指导 HF 管理是安全的,显著减少了高危患者的住院次数。这些结果支持实施这种创新的远程管理策略,以改善有症状 HF 患者的预后。临床注册编号:ClinicalTrials.gov 标识符:NCT02954341。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/39c2/8787982/eeb3d90c066c/EHF2-9-48-g003.jpg

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