{"id":"00e87b21fc7e","type":"article","url":"https://hartvaat.nl/2023/08/01/atrial-flow-regulator-en-overleving-bij-hartfalen-voorspelde-impact/","title":"Atrial flow regulator en overleving bij hartfalen: voorspelde impact","title_en":"Predicted impact of atrial flow regulator on survival in heart failure with reduced and preserved ejection fraction.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":["acuut-hartfalen","hfpef","hfref","step-hfpef"],"journal":"ESC heart failure","doi":"10.1002/ehf2.14384","source_url":"https://doi.org/10.1002/ehf2.14384","authors":["Lucas Lauder","Martin W Bergmann","Christina Paitazoglou","Ramazan Özdemir","Christos Iliadis","Jozef Bartunek","Alexander Lauten","Thomas Keller","Stephan Weber","Horst Sievert","Stefan D Anker","Felix Mahfoud"],"significance":5,"published":"2023-08-01","source_date":"2023-08-01","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/wat-is-atriumfibrilleren/"],"congress":"","summary_en":"This modeling study predicted the potential survival impact of the atrial flow regulator device in heart failure, providing theoretical estimates of benefit to guide clinical development.","created":"2026-07-03T10:30:30Z","updated":"2026-07-03T18:39:05Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Modelleringstudie voorspelde het potentiële overlevingsvoordeel van de atrial flow regulator bij hartfalen. Het device zou het meest profiteren bij HFpEF met ernstige symptomen. Gerandomiseerde uitkomstdata zijn nodig.","abstract_original":"AIMS: We aim to assess the theoretical impact of the atrial flow regulator (AFR) on survival in heart failure. METHODS AND RESULTS: The prospective, multicentre, open-label, non-randomised PRELIEVE study (NCT03030274) assessed the safety and efficacy of the Occlutech AFR device in patients with symptomatic heart failure with reduced ejection fraction (HFrEF) (left ventricular ejection fraction (LVEF) ≥ 15% and <40%) or heart failure with preserved ejection fraction (HFpEF) (LVEF ≥40% and <70%) and elevated PCWP (≥15 mmHg at rest or ≥25 mmHg during exercise). In this analysis, after the first 60 patients completed 12 months of follow-up, the theoretical impact of AFR implantation on survival was assessed by comparing the observed mortality rate with the median predicted probability for one-year mortality. Each subject's risk of mortality was predicted from individual baseline data using the Meta-Analysis Global Group in Chronic HF (MAGGIC) prognostic model. A total of 87 patients (46% female, median age 69 years [IQR 62-74]) had undergone successful device implantation for the treatment of HFrEF (53%) and HFpEF (47%). Sixty patients had a complete 12 month follow-up. The median follow-up was 351 days (interquartile range [IQR] 202-370). Six (7%) patients died during follow-up (8.6 deaths per 100 patient-years; 95% confidence interval [CI] 2.7 to 15.5), all of which had HFrEF. The median predicted mortality rate for the overall study population was 12.2 deaths per 100 patient-years (95% CI 10.2 to 14.7). While the observed mortality rate (0 deaths per 100 patient-years) was significantly lower than the median predicted mortality rate (9.3 deaths per 100 patient-years; 95% CI 8.4 to 11.1) in patients with HFpEF (-9.3 deaths per 100 patient-years; 95% CI -11.1 to -8.4), there was no difference in patients with HFrEF (-3.6 deaths per 100 patient-years; 95% CI -9.5 to 3.0). Four deaths were HF-related deaths (5.7 HF-related deaths per 100 patient-years; 95% CI 1.4 to 11.9; 10.8 HF-related deaths per 100 patient-years; 95% CI 2.5 to 23.1 in the HFrEF subgroup). CONCLUSIONS: In patients with HFpEF, the mortality rate following AFR implantation was lower than the predicted mortality rate. Dedicated randomised, controlled trials are needed - and currently ongoing - to investigate whether the AFR improves mortality."}