One-year results of the first-in-man study investigating the Atrial Flow Regulator for left atrial shunting in symptomatic heart failure patients: the PRELIEVE study.
Eur J Heart Fail
; 23(5): 800-810, 2021 05.
Article
em En
| MEDLINE
| ID: mdl-33555114
ABSTRACT
AIMS:
Attenuating exercise-induced elevated left atrial pressure with an atrial shunt device is under clinical investigation for treatment of symptomatic heart failure (HF). METHODS ANDRESULTS:
PRELIEVE was a prospective, non-randomised, multicentre, first-in-man study in symptomatic HF patients with reduced (HFrEF) or preserved (HFpEF) ejection fraction and pulmonary capillary wedge pressure (PCWP) ≥15 mmHg at rest or ≥25 mmHg during exercise. Here, we provide follow-up data up to 1 year after implantation of the Atrial Flow Regulator (AFR) device. The AFR was successfully implanted in 53 patients (HFrEF n = 24 and HFpEF n = 29). Two patients were not enrolled due to an unsuccessful transseptal puncture. There was one device embolisation into the left atrium, which required surgical removal. One patient experienced a serious procedure-related adverse event (post-procedural bleeding and syncope). All patients with sufficient echocardiography readout confirmed device patency with left-right shunt both at 3 (n = 47/51, 92%) and 12 (n = 45/49, 92%) months. At 3 months, rest PCWP decreased by 5 (-12, 0) mmHg (P = 0.0003, median Q1, Q3). No patient developed a stroke, worsening of right heart function or significant increase of pulmonary artery pressure. Six (6/53, 11%) patients were hospitalised for worsening of HF and three (3/53, 6%) patients died. We observed improvements in New York Heart Association functional class, 6-min walking distance and quality of life (Kansas City Cardiomyopathy Questionnaire) in certain patients.CONCLUSIONS:
Implantation of the AFR device in HF patients was feasible. No shunt occlusion, stroke or new right HF was observed during the 1-year follow-up, with clinical improvements in certain patients.Palavras-chave
Texto completo:
1
Bases de dados:
MEDLINE
Assunto principal:
Insuficiência Cardíaca
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
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Observational_studies
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Risk_factors_studies
Limite:
Humans
Idioma:
En
Revista:
Eur J Heart Fail
Assunto da revista:
CARDIOLOGIA
Ano de publicação:
2021
Tipo de documento:
Article
País de afiliação:
Alemanha