Atrial Shunt Device Effects on Cardiac Structure and Function in Heart Failure With Preserved Ejection Fraction: The...

Area of Science:

• Cardiology
• Medical Devices
• Clinical Trials

Background:

• Heart failure with preserved ejection fraction (HFpEF) presents challenges in treatment.
• Atrial shunting is an emerging therapy to reduce elevated left atrial pressure.
• The REDUCE LAP-HF II trial investigated an atrial shunt device for HFpEF/HFmrEF.

Purpose of the Study:

• To evaluate the cardiac structure and function effects of an atrial shunt versus sham control.
• To analyze these effects stratified by patient responder status.

Main Methods:

• A sham-controlled randomized clinical trial involving 621 patients with HFpEF/HFmrEF.
• Utilized echocardiography to assess cardiac measures at multiple time points up to 24 months.
• Post hoc analysis focused on responder status (no latent pulmonary vascular disease, no CRM device).

Main Results:

• Overall, the atrial shunt reduced left ventricular and left atrial volumes and improved LV systolic function.
• Shunt therapy increased right ventricular and right atrial volumes without impacting RV systolic function or pressures.
• Responders demonstrated more favorable cardiac structural and functional changes compared to non-responders.

Conclusions:

• Atrial shunting leads to reverse remodeling of left-sided heart chambers and volume changes in right-sided chambers.
• The therapy's benefits were more pronounced in identified responders, supporting the responder hypothesis.
• Further long-term evaluation is necessary to fully understand the impact of atrial shunting.