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植入式心脏复律除颤器的远程监测与门诊监测:葡萄牙一项随机实用对照研究的结果

Remote versus in-office monitoring for implantable cardioverter defibrillators: Results from a randomized pragmatic controlled study in Portugal.

作者信息

Oliveira Mário, Fernandes Milene, Reis Hipólito, Primo João, Sanfins Victor, Silva Vânia, Cunha Pedro Silva, Silva Mónica, Nicola Paulo J

机构信息

Centro Hospitalar Universitário Lisboa Central, Lisboa, Portugal.

Instituto de Medicina Preventiva e Saúde Pública, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.

出版信息

Rev Port Cardiol. 2022 Dec;41(12):987-997. doi: 10.1016/j.repc.2021.08.017. Epub 2022 Oct 11.

DOI:10.1016/j.repc.2021.08.017
PMID:36229282
Abstract

INTRODUCTION

Remote monitoring (RM) is a safe and effective alternative to in-office conventional follow-up.

OBJECTIVE

We aimed to evaluate patient satisfaction with RM and its impact on healthcare resources in a population with cardiac implantable electronic devices.

METHODS

Randomized, pragmatic, open-label controlled trial, with adult wearers of implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy with ICD (CRT-D), eligible for the CareLink® system. Patients newly implanted or with previous conventional follow-up were randomized to RM or conventional follow-up (control), and followed for 12 months, according to the centers' practice. The number of in-office visits and adverse events were compared between groups. Patient and healthcare professionals' satisfaction with RM were described.

RESULTS

Of the 134 randomized patients (69 RM; 65 control, aged 60±13 years), 80% were male, 23% employed, 72% ICD wearers and 54% newly implanted. Most patients (70%) reported travel costs less than 15€/visit, and 46% daily routine interference with in-office visits. Median physician/technician time with patient was 15 min/15 min, per in-office visit. Excluding baseline and final visits, control patients had more in-office visits in total: median 1 vs. 0, p<0.001. In 81% of the in-office visits, no clinical measures were taken. There were 10 adverse events, with no differences between groups. At the final visit, 95% of RM patients considered RM easy/very easy to use, and would all prefer to maintain RM and recommend it to others. All professionals found the CareLink website easy/very easy to use and were satisfied with transmission data.

CONCLUSIONS

In a Portuguese population with ICD and CRT-D, RM safely reduced the burden of in-office visits, with high levels of satisfaction among patients and healthcare professionals.

摘要

引言

远程监测(RM)是门诊传统随访的一种安全有效的替代方式。

目的

我们旨在评估心脏植入式电子设备人群对远程监测的满意度及其对医疗资源的影响。

方法

这是一项随机、实用、开放标签的对照试验,纳入了符合CareLink®系统条件的植入式心律转复除颤器(ICD)成年佩戴者或ICD心脏再同步治疗(CRT-D)患者。新植入或之前接受过传统随访的患者被随机分为远程监测组或传统随访组(对照组),并根据各中心的惯例随访12个月。比较两组的门诊就诊次数和不良事件。描述患者和医疗专业人员对远程监测的满意度。

结果

在134例随机分组的患者中(69例远程监测组;65例对照组,年龄60±13岁),80%为男性,23%有工作,72%为ICD佩戴者,54%为新植入患者。大多数患者(70%)报告每次就诊的交通费用低于15欧元,46%的患者表示门诊就诊对日常活动有干扰。每次门诊时,医生/技术人员与患者相处的中位时间为15分钟/15分钟。排除。排除基线和末次就诊,对照组患者的门诊就诊总次数更多:中位数为1次对0次,p<0.001。在81%的门诊就诊中,未采取任何临床措施。共发生10起不良事件,两组之间无差异。在末次就诊时,95%的远程监测组患者认为远程监测易于/非常易于使用,并且都愿意继续使用远程监测并推荐给他人。所有专业人员都认为CareLink网站易于/非常易于使用,并对传输数据感到满意。

结论

在葡萄牙的ICD和CRT-D患者人群中,远程监测安全地减轻了门诊就诊负担,患者和医疗专业人员的满意度较高。

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