Interatrial shunt therapy in advanced heart failure: Outcomes from the open‐label cohort of the RELIEVE‐HF trial

Aims Heart failure (HF) outcomes remain poor despite optimal guideline‐directed medical therapy (GDMT). We assessed safety, effectiveness, and transthoracic echocardiographic (TTE) outcomes during the 12 months after Ventura shunt implantation in the RELIEVE‐HF open‐label roll‐in cohort. Methods and...

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Bibliographic Details
Published in:European journal of heart failure 2024-04, Vol.26 (4), p.1078-1089
Main Authors: Rodés‐Cabau, Josep, Lindenfeld, JoAnn, Abraham, William T., Zile, Michael R., Kar, Saibal, Bayés‐Genís, Antoni, Eigler, Neal, Holcomb, Richard, Núñez, Julio, Lee, Elizabeth, Perl, Michal Laufer, Moravsky, Gil, Pfeiffer, Michael, Boehmer, John, Gorcsan, John, Bax, Jeroen J., Anker, Stefan, Stone, Gregg W.
Format: Article
Language:English
Subjects:
Aged
Echocardiography - methods
Female
Heart Atria - diagnostic imaging
Heart Atria - physiopathology
Heart failure
Heart Failure - physiopathology
Heart Failure - therapy
Humans
Implant
Kansas City Cardiomyopathy Questionnaire
Left ventricular function
Male
Middle Aged
RELIEVE‐HF
Right ventricular function
Stroke Volume - physiology
Transthoracic echocardiography
Treatment Outcome
Ventricular Function, Left - physiology
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Summary:Aims Heart failure (HF) outcomes remain poor despite optimal guideline‐directed medical therapy (GDMT). We assessed safety, effectiveness, and transthoracic echocardiographic (TTE) outcomes during the 12 months after Ventura shunt implantation in the RELIEVE‐HF open‐label roll‐in cohort. Methods and results Eligibility required symptomatic HF despite optimal GDMT with ≥1 HF hospitalization in the prior year or elevated natriuretic peptides. The safety endpoint was device‐related major adverse cardiovascular or neurological events at 30 days, compared to a prespecified performance goal. Effectiveness evaluations included the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline, 1, 3, 6, and 12 months and TTE at baseline and 12 months. Overall, 97 patients were enrolled and implanted at 64 sites. Average age was 70 ± 11 years, 97% were in New York Heart Association class III, and half had left ventricular ejection fraction (LVEF) ≤40%. The safety endpoint was achieved (event rate 0%, p 
ISSN:1388-9842
1879-0844
1879-0844
DOI:10.1002/ejhf.3215