JACC. Heart failure
October 13, 2026 · via Europe PMC
Long-Term Safety and Procedural Performance of an Interatrial Shunt for Heart Failure According to Ejection Fraction.
Rodés-Cabau J, Stone GW, Kar S, +25 more, Lindenfeld J
AI summary — for doctors, generated from the abstract only
The interatrial shunt was mechanically reliable through 2 years, but safety differed by phenotype: no excess events in HFrEF, more adverse events in HFpEF.
What was studied
Prespecified analysis of the RELIEVE-HF randomized, sham-controlled trial of an interatrial shunt, stratified by LVEF (HFrEF at 40% or below, HFpEF above 40%), assessing procedural performance, durability, serious adverse events, MACNE, major bleeding, and renal outcomes through 2 years.
Key findings
- Implantation was successful in 369 of 370 attempts (99.7%), and shunt patency was 99.4% (95% CI 97.9%-99.9%).
- No device- or procedure-related MACNE occurred through 2 years in implanted patients with follow-up (0%; 95% CI 0%-0.9%).
- In HFpEF, shunt therapy was associated with higher all-cause MACNE, serious adverse events, major bleeding, and renal decline, while HFrEF showed no excess.
Clinical relevance
The data argue for phenotype-specific evaluation, with caution about shunt therapy in HFpEF.
Who should care
Limitations
This is a subgroup and safety analysis, and the abstract reports no effect sizes for the HFpEF versus HFrEF safety differences. Efficacy results are not covered here.
The shunt itself worked and stayed open, but HFpEF patients had worse safety signals than HFrEF patients.
This is an AI-generated summary of the published abstract, not a clinical recommendation. It may not reflect the full text or subsequent updates — verify against the original source before acting on it.
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).
DOI
10.1016/j.jchf.2026.103375
PMID
42886087
Research metadata (titles, abstracts, authors, publication dates) is sourced from Europe PMC, which aggregates content from PubMed/MEDLINE, PubMed Central, and other providers under the U.S. National Library of Medicine (NLM/NCBI). NLM does not claim copyright on abstracts; the original journal publishers or authors may hold rights to the full articles. AI-generated summaries are derived only from the abstract, never the full text, and are always labeled as AI-generated.
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