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Long term safety and outcomes after atrial shunting for heart failure with preserved or mildly reduced ejection fraction: 5-year and 3-year follow-up in the REDUCE LAP-HF I and II trials.
Am Heart J
December 2024
Department of Internal Medicine, Northwestern University, Chicago, IL.
Article Synopsis
- * In the first trial (RCT-I), there were no significant differences in important health outcomes like cardiovascular mortality or stroke, while the second trial (RCT-II) showed a benefit in responder patients using shunts over a sham treatment.
- * The atrial shunt treatment in responders led to fewer heart failure events and better health-related quality of life measured by KCCQ, but also had a higher rate of ischemic stroke and reduced worsening kidney dysfunction compared to sham treatment.
Waiting for Godot?: REDUCE LAP HF-II at 24 Months.
JACC Heart Fail
August 2024
Department of Internal Medicine, Division of Cardiovascular Medicine, Spencer Fox Eccles School of Medicine, University of Utah, Salt Lake City, Utah, USA. Electronic address:
2-Year Outcomes of an Atrial Shunt Device in HFpEF/HFmrEF: Results From REDUCE LAP-HF II.
JACC Heart Fail
August 2024
Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA. Electronic address:
Article Synopsis
- - The
- REDUCE LAP-HF II
- trial showed that the
- Corvia Atrial Shunt
- did not improve heart failure outcomes compared to a sham procedure, despite identifying "responders" who exhibited better exercise-related metrics after 12 months.
- - This study aimed to assess the
- long-term efficacy and safety
- of the atrial shunt over 2 years, focusing on both overall patient outcomes and distinctions between responders and nonresponders.
- - Results from
- 621 patients
- indicated no significant difference in major health events between the shunt and sham groups, but those with shunts experienced a higher rate of major adverse cardiac events and increased right ventricular volume; however, responders showed improved outcomes compared to the sham
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
June 2024
Bluhm Cardiovascular Institute, Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
Importance: Although the results of A Study to Evaluate the Corvia Medical Inc IASD System II to Reduce Elevated Left Atrial Pressure in Patients with Heart Failure (REDUCE LAP-HF II) trial were neutral overall, atrial shunt therapy demonstrated potential efficacy in responders (no latent pulmonary vascular disease and no cardiac rhythm management device). Post hoc analyses were conducted to evaluate the effect of shunt vs sham stratified by responder status.
Objective: To evaluate the effect of atrial shunt vs sham control on cardiac structure/function in the overall study and stratified by responder status.
Aims: Obesity is causally related to the development of heart failure with preserved ejection fraction (HFpEF) but complicates the diagnosis and treatment of this disorder. We aimed to determine the relationship between severity of obesity and clinical, echocardiographic and haemodynamic parameters in a large cohort of patients with documented HFpEF.
Methods And Results: The REDUCE LAP-HF II trial randomized 626 patients with ejection fraction ≥40% and exercise pulmonary capillary wedge pressure (PCWP) ≥25 mmHg to atrial shunt or sham procedure.
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