Heart failure & cardiomyopathies
Atrial Shunt Device Effects on Cardiac Structure and Function in Heart Failure With Preserved Ejection Fraction: The REDUCE LAP-HF II Randomized Clinical Trial
Authors' conclusion
In this post hoc analysis of the REDUCE LAP-HF II trial, over 2 years of follow-up, atrial shunting led to reverse remodeling of left-sided chambers and increases in volume of right-sided chambers consistent with the shunt flow but no change in RV systolic function compared with sham.
Study context
- Population
- Heart failure with preserved ejection fraction (HFpEF)/HF with mildly reduced EF, with evaluable echocardiographymodified ITT
- Participants
- 621 participants
- Comparison
- Atrial shunt device vs sham control
- Shuntn = 309
- Sham controln = 312reference
- Primary endpoint
- Changes in echocardiographic measures from baseline
- Follow-up
- 1, 6, 12, and 24 months after index procedure
Methodological detailssham-controlled, 89 international centres, modified ITT, Data analyzed April 2023 to January 2024
- Sham-controlled
- 89 international centres
- Modified ITT
- Data analyzed April 2023 to January 2024
Primary result
As reported in the abstract
Echocardiographic changes, overall population · through 24 months
- Left ventricular (LV) end-diastolic volume
- mean difference −5.65 mL; P < 0.001
- Left atrial (LA) minimal volume
- mean difference −2.8 mL; P = 0.01
- LV systolic tissue Doppler velocity
- mean difference 0.69 cm/s; P < 0.001
- LA emptying fraction
- mean difference 1.88 percentage units; P = 0.02
- Right ventricular (RV) volume
- mean difference 9.58 mL; P < 0.001
- Right atrial (RA) volume
- mean difference 9.71 mL; P < 0.001
Further findings
- Shunt patency (shunt patients with evaluable echocardiograms) · through 24 months
- 98% · 212
- Shunt patency (shunt patients with evaluable echocardiograms): 212 of 217
Echocardiographic changes, responders vs nonresponders within shunt (subgroup)
- RV end-diastolic volume: mean difference 5.71 mL vs 15.18 mL
- interaction P =.01
- RV end-systolic volume: mean difference 1.58 mL vs 7.89 mL
- interaction P =.002
- RV/LV ratio: mean difference 0.07 vs 0.20
- interaction P <.001
- Transmitral A wave velocity: mean difference 5.08 cm/s vs −1.97 cm/s
- interaction P =.02
- Responders: no latent pulmonary vascular disease and no cardiac rhythm management device
- Post hoc
Original publication
Atrial Shunt Device Effects on Cardiac Structure and Function in Heart Failure With Preserved Ejection Fraction: The REDUCE LAP-HF II Randomized Clinical Trial. JAMA Cardiol. Published 1 June 2024. doi:10.
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