Clinical ResearchExercise-Induced Left Atrial Hypertension in Heart Failure With Preserved Ejection Fraction
Central Illustration
Section snippets
REDUCE LAP-HF II study design and objectives
The objectives and design of the REDUCE LAP-HF II study have been previously described in detail.3 Briefly, REDUCE LAP-HF II was a multicenter, international, randomized, double-blind, sham-controlled trial of the Corvia Atrial Shunt in adults with HF and LVEF ≥40%. After comprehensive noninvasive and invasive hemodynamic screening, eligible participants were randomly assigned 1:1 to receive the Corvia Atrial Shunt (IASD System II) or a sham control procedure.5,6 The primary endpoint was a
Enrollment of REDUCE LAP II study participants
Patients in the EILAH group were slightly younger, with similar distribution of sex, race/ethnicity, and obesity (Table 1). The EILAH group was less likely to have hypertension, diabetes, chronic kidney disease, and current or prior atrial fibrillation. Patients with EILAH had higher estimated glomerular filtration rate, lower use of loop diuretic agents and beta-adrenergic blocking agents, but higher use of mineralocorticoid receptor agonists (Table 1, Supplemental Table 1).
NYHA functional
Discussion
In this large, randomized trial of a novel device therapy in hemodynamically defined HFpEF, almost one-third of subjects had a resting PCWP <15 mm Hg but elevation of PCWP to ≥25 mm Hg with supine exercise. Symptom severity was similar in the groups with normal or elevated resting PCWP (both groups predominantly NYHA functional class III with similar KCCQ clinical summary score). However, those with EILAH had ∼50% lower natriuretic peptide levels; fewer comorbidities; and many clinical,
Conclusions
In a large, rigorously phenotyped cohort of patients with hemodynamically verified HFpEF or HF with mildly reduced ejection fraction, almost one-third had normal LV filling pressures at rest. Exercise evaluation is necessary to unmask the underlying cardiac limitations in these patients. Although they have significant impairment of quality of life, these patients appear to have a less advanced stage of myocardial and pulmonary vascular dysfunction. Importantly, they have a number of
Funding Support and Author Disclosures
This study was sponsored by Corvia Medical Inc. Dr Litwin has received research funding from the department of Veterans Affairs, Corvia, AstraZeneca, V-Wave, Axon Therapeutics, and Eli Lilly all paid to the institution; has received consulting fees from CVRx, Axon Therapeutics, Occlutech, Eli Lilly, and Rivus Pharmaceuticals; and has received travel grants, speaker fees, and advisory board honoraria from NovoNordisk and Roche. Dr Komtebedde is employed by Corvia. Dr Burkhoff has consulted for
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Cited by (12)
Medical Management and Device-Based Therapies in Chronic Heart Failure
2023, Journal of the Society for Cardiovascular Angiography and InterventionsAtrial Shunt Therapy for Heart Failure: An Update
2023, Journal of the Society for Cardiovascular Angiography and InterventionsWhy Do Exercise Hemodynamics Matter?
2023, Journal of Cardiac FailureThe Intriguing Links Among Patent Foramen Ovale, Patent Foramen Ovale Closure, and the Risk for Heart Failure
2023, Journal of the American Society of Echocardiography
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