Effect of remote monitoring on patient-reported outcomes in European heart failure patients with an implantable cardioverter-defibrillator: primary results of the REMOTE-CIED randomized trial.
Europace
; 21(9): 1360-1368, 2019 Sep 01.
Article
em En
| MEDLINE
| ID: mdl-31168604
ABSTRACT
AIMS:
The European REMOTE-CIED study is the first randomized trial primarily designed to evaluate the effect of remote patient monitoring (RPM) on patient-reported outcomes in the first 2 years after implantation of an implantable cardioverter-defibrillator (ICD). METHODS ANDRESULTS:
The sample consisted of 595 European heart failure patients implanted with an ICD compatible with the Boston Scientific LATITUDE® RPM system. Patients were randomized to RPM plus a yearly in-clinic ICD check-up vs. 3-6-month in-clinic check-ups alone. At five points during the 2-year follow-up, patients completed questionnaires including the Kansas City Cardiomyopathy Questionnaire and Florida Patient Acceptance Survey (FPAS) to assess their heart failure-specific health status and ICD acceptance, respectively. Information on clinical status was obtained from patients' medical records. Linear regression models were used to compare scores between groups over time. Intention-to-treat and per-protocol analyses showed no significant group differences in patients' health status and ICD acceptance (subscale) scores (all Ps > 0.05). Exploratory subgroup analyses indicated a temporary improvement in device acceptance (FPAS total score) at 6-month follow-up for secondary prophylactic in-clinic patients only (P < 0.001). No other significant subgroup differences were observed.CONCLUSION:
Large clinical trials have indicated that RPM can safely and effectively replace most in-clinic check-ups of ICD patients. The REMOTE-CIED trial results show that patient-reported health status and ICD acceptance do not differ between patients on RPM and patients receiving in-clinic check-ups alone in the first 2 years after ICD implantation.ClinicalTrials.gov Identifier NCT01691586.Palavras-chave
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Qualidade de Vida
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Morte Súbita Cardíaca
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Desfibriladores Implantáveis
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Monitorização Ambulatorial da Pressão Arterial
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Eletrocardiografia
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Tecnologia de Sensoriamento Remoto
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Assistência Ambulatorial
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Medidas de Resultados Relatados pelo Paciente
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Insuficiência Cardíaca
Tipo de estudo:
Clinical_trials
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Guideline
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Prognostic_studies
Limite:
Aged
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Female
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Humans
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Male
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Middle aged
País como assunto:
Europa
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article