Largest-Ever Device Study Conducted in Diastolic Heart Failure Finds Patients Can Benefit From Atrial Shunt

A new study has found that some patients suffering from heart failure with preserved ejection fraction (HFpEF), also called diastolic heart failure, may benefit from a novel, minimally invasive cardiac implant device called an atrial shunt.

The trial conducted by researchers at Northwestern Medicine (Chicago, IL, USA) was the largest device study ever conducted in diastolic heart failure and the first pivotal trial of interatrial shunts. HFpEF affects millions globally. The study also offers new insight into the role exercise plays in understanding, diagnosing and treating this type of heart failure. Despite being a common type of heart failure, effective treatments remain elusive, leading to high morbidity and mortality. This type of heart failure occurs when the left ventricle is unable to relax, limiting the amount of blood filling into the heart, which causes fluid to build up in the lungs and the body, causing symptoms including shortness of breath, fluid retention, irregular heartbeat, and exercise intolerance.

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An atrial shunt is placed through a catheter, creating a small hole between the left and right atria allowing blood to flow from the stiff left atrium to the normal right atrium, potentially lowering pressure in the left atrium and reducing the symptoms of HFpEF. The procedure is minimally invasive, low-risk and patients go home the next day. While cardiovascular conditions such as coronary artery disease are routinely diagnosed with exercise testing, clinical assessment for HFpEF is done at rest - something that the researchers hope will change following this trial.

“While the overall trial was neutral, in our subgroup analyses, we found that what happens in the heart and lungs during exercise is of prime importance in this type of heart failure,” said Sanjiv Shah, MD, director of research at the Bluhm Cardiovascular Institute and director of the Northwestern Medicine HFpEF Program. “The normal response to exercise is relaxation of the blood vessels in the lungs. Patients with HFpEF who are able to relax the blood vessels in their lungs appear to do well with the device, whereas those whose blood vessels can’t relax appear to do worse when an atrial shunt is implanted.”

“What we saw in this study is encouraging and suggests that future clinical trials should specifically investigate the subgroup of patients with HFpEF whose pulmonary blood vessels respond normally to exercise,” said Dr. Shah, international principal investigator of the trial. “If future trials validate what we found, the potential is enormous. This subgroup comprises two thirds of people with this type of heart failure - that is two million people could benefit from this innovative therapy. This simple, one-time procedure could reduce hospitalizations and significantly improve quality of life.”

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