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

Josep Rodés-Cabau, Quebec Heart & Lung Institute, Laval University, Quebec City, Québec, Canada.
JoAnn Lindenfeld, Division of Cardiology, Vanderbilt University Medical Center, Nashville, TN, USA.
William T. Abraham, Division of Cardiovascular Medicine, Davis Heart and Lung Research Institute, The Ohio State University Wexner Medical Center, Columbus, OH, USA.
Michael R. Zile, Division of Cardiology, Medical University of South Carolina, Ralph H. Johnson Department of Veterans Affairs Medical Center, Charleston, SC, USA.
Saibal Kar, Cardiovascular Institute of Los Robles Health System, Los Robles, CA, USA.
Antoni Bayés-Genís, Department of Cardiology, Germans Trias Heart Institute, Germans Trias University Hospital, Badalona, Spain.
Neal Eigler, V-Wave, Agoura Hills, California and Division of Cardiology, Smidt Heart Institute, Cedars Sinai Medical Center, Los Angeles, CA, USA.
Richard Holcomb, Independent Biostatistician, Minneapolis, MN, USA.
Julio Núñez, Department of Cardiology, University of Valencia, Valencia, Spain.
Elizabeth Lee, Rochester Regional HealthFollow
Michal Laufer Perl, Division of Cardiology, Sammy Ofer Heart Center, Tel Aviv Sourasky Medical Center, Tel Aviv-Yafo, Israel.
Gil Moravsky, Division of Cardiology, Shamir Medical Center (Assaf HaRofeh), Be'er Ya'akov, Israel.
Michael Pfeiffer, Division of Cardiology, Penn State Heart and Vascular Institute, Milton S. Hershey Medical Center, Hershey, PA, USA.
John Boehmer, Division of Cardiology, Penn State Heart and Vascular Institute, Milton S. Hershey Medical Center, Hershey, PA, USA.
John Gorcsan, Division of Cardiology, Penn State Heart and Vascular Institute, Milton S. Hershey Medical Center, Hershey, PA, USA.
Jeroen J. Bax, Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.
Stefan Anker, Department of Cardiology (CVK) of German Heart Center Charité, Institute of Health Center for Regenerative Therapies (BCRT), German Centre for Cardiovascular Research (DZHK) Partner Site Berlin, Charité University, Berlin, Germany.
Gregg W. Stone, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

Department

Cardiology

Document Type

Article

Publication Title

European Journal of Heart Failure

Abstract

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 < 0.001). KCCQ overall summary score was improved by 12-16 points at all follow-up timepoints (all p < 0.004), with similar outcomes in patients with reduced and preserved LVEF. At 12 months, left ventricular end-systolic and end-diastolic volumes were reduced (p = 0.020 and p = 0.038, respectively), LVEF improved (p = 0.009), right ventricular end-systolic and end-diastolic areas were reduced (p = 0.001 and p = 0.030, respectively), and right ventricular fractional area change (p < 0.001) and tricuspid annular plane systolic excursion (p < 0.001) improved.

Conclusion: Interatrial shunting with the Ventura device was safe and resulted in favourable clinical effects in patients with HF, regardless of LVEF. Improvements of left and right ventricular structure and function were consistent with reverse myocardial remodelling. These results would support the potential of this shunt device as a treatment for HF.

First Page

1078

Last Page

1089

DOI

10.1002/ejhf.3215

Volume

26

Issue

4

Publication Date

4-1-2024

Medical Subject Headings

Humans; Heart Failure (physiopathology, therapy); Female; Male; Aged; Stroke Volume (physiology); Echocardiography (methods); Treatment Outcome; Ventricular Function, Left (physiology); Heart Atria (physiopathology, diagnostic imaging); Middle Aged

PubMed ID

38561314

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