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Long-Term Safety and Procedural Performance of an Interatrial Shunt for Heart Failure According to Ejection Fraction.

J. Rodés-Cabau Gregg W. Stone S. Kar S. Verheye A. Roguin Jeroen J. Bax A. Bayés-Genís Julio Núñez Jeremiah P. Depta M. Laufer-Perl G. Moravsky Alicia Romero Edgard Prihadi E. Chung Matthew J. Price Michael S. Chenier D. Schewel Sachin Kumar S. Kische Kunjan Bhatt Kevin S. Shah Daniel J. Donovan S. Hendrix Patrick O'Keefe William T. Abraham M. Zile Stefan D. Anker Neal L. Eigler J. Lindenfeld

Oct 2026 · JACC. Heart failure · pp. 103375 · 1 citation · 19 references

Medicine

Abstract

Background

Long-term device durability and phenotype-specific safety outcomes after interatrial shunting require further characterization.

Objectives

This study aimed to evaluate the procedural success, device durability, and heart failure (HF) phenotype-specific safety outcomes of an interatrial shunt in the RELIEVE-HF trial.

Methods

Randomized patients were assigned 1:1 to shunt or sham control with prespecified stratification by left ventricular ejection fraction (LVEF) into heart failure with reduced ejection fraction (HFrEF) (LVEF ≤40%) and heart failure with preserved ejection fraction (HFpEF) (LVEF >40%). Procedural performance, device durability, serious adverse events (SAEs), major adverse cardiovascular or neurological events (MACNE), major bleeding, and renal outcomes were assessed through 2 years.

Results

Among 605 enrolled patients (508 randomized; 97 roll-in), shunt implantation was attempted in 370 and was successful in 369 (99.7%). Among implanted patients with follow-up (n = 348), no device- or procedure-related MACNE occurred through 2 years (0%; 95% CI: 0%-0.9%), and shunt patency was 99.4% (95% CI: 97.9%-99.9%). Prespecified LVEF-stratified analyses demonstrated divergent safety profiles. In HFrEF, shunt therapy was not associated with excess all-cause MACNE, major bleeding, or renal decline and was associated with lower SAE burden. In HFpEF, shunt therapy was associated with higher all-cause MACNE, greater SAE burden, increased major bleeding, and greater renal decline.

Conclusions

Interatrial shunt implantation was mechanically reliable and durable through 2 years. Safety outcomes differed by HF phenotype, with no evidence of excess clinical safety events in HFrEF but increased adverse events in HFpEF. These findings support phenotype-specific evaluation of interatrial shunt therapy. (REducing Lung congestion symptoms using the v-wavE shunt in adVancEd Heart Failure [RELIEVE-HF]; NCT03499236).

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