Pittsburgh’s AHN Allegheny General Hospital First in Pennsylvania to Enroll Cardiac Patients in International Clinical Trial Exploring Latest Investigational Therapy for Heart[...]

A novel shunt connecting the heart's atria can reduce pressure in the lungs and left side of the heart, mitigating heart failure symptoms

PITTSBURGH - Allegheny General Hospital (AGH), the flagship medical facility of Allegheny Health Network (AHN), is now enrolling patients in a clinical trial to further evaluate the safety and effectiveness of an investigational atrial shunt designed to reduce hospitalizations and symptoms caused by heart failure with preserved ejection fraction (HFpEF).

Heart failure currently affects at least 26 million people worldwide including 7 million Americans, and these numbers are expected to grow as obesity and diabetes rates increase and the population ages. Though it comes in different forms, heart failure typically causes shortness of breath, fatigue, and swelling in the legs and ankles. Without effective treatment, quality of life will eventually deteriorate.

While there are several medications and interventions to treat heart failure with weakened heart muscles (reduced EF), HFpEF has been stubbornly resistant to current available therapies. In these patients, the heart muscle is strong enough to pump blood normally, but it is too stiff to fill and empty properly.

HFpEF now accounts for over half of all heart failure diagnoses, and is more common in women than in men.

The international RESPONDER-HF trial is being led at AGH by Hayah Kassis-George, MD, an AHN Cardiovascular Institute cardiologist specializing in the treatment of advanced heart failure and pulmonary hypertension.

AGH is the first hospital in Pennsylvania to randomize patients into the trial, which is exploring a novel heart failure therapy from Corvia Medical Inc., she said.

More than 65 premier medical centers on three continents worldwide are participating in the RESPONDER-HF trial.

"Cardiovascular medicine doesn't yet have a reliable suite of effective therapies for this particular patient population," said Dr. Kassis-George. "Our participation in this trial is promising, and we look forward to giving our patients access to a new, minimally invasive option that could potentially relieve their fatigue and breathlessness and notably improve their overall quality of life."

Heart failure is a common cardiovascular condition that occurs when the heart is unable to pump blood sufficiently throughout the body. A normal ejection fraction (EF) - a measurement of how much blood is pumped out of the left ventricle with a single heartbeat - is between 50% and 75%.

HFpEF is a specific form of heart failure in which patients have a largely normal EF (anything between 40 - 75%), but in which the muscles within the left ventricle and left atrium are notably stiff. As a result, re-oxygenated blood cannot completely fill the left ventricle and subsequently exit the left side of the heart, which causes pressure to build up inside the lungs and left heart chambers.

Notable symptoms of this form of heart failure include breathlessness, fatigue and depression. HFpEF - sometimes descriptively called "huff puff" and previously known as diastolic heart failure - also causes significant shortness of breath in patients with any level of exertion. Therapeutic options have been historically limited to medical therapies indicated for other types of heart failure.

As part of this clinical trial, patients are randomized to undergo a minimally invasive catheter-based procedure performed by an interventional cardiologist or electrophysiologist. The physician inserts a catheter through a vein in the groin to access the heart and creates a small passage between the two upper chambers of the heart for shunt insertion. The shunt's strategic placement allows blood to flow through the device from the left to the right atrium (upper chambers of the heart) to relieve pressure buildup in the left ventricle, as needed, and allow the patient to breathe easier.

A previous clinical trial evaluating the shunt and published in 2022 in Circulation (DOI: 10.1161/CIRCULATIONAHA.122.059486) demonstrated that certain patients benefitted significantly from the atrial shunt. In the selected patient population, heart failure events decreased by 45% and there was a 55% improvement in health status and quality of life vs. the control group at one year. In earlier pilot studies, it was also shown that the Corvia Atrial Shunt improved the quality of life in 75% of patients, and 69% of patients were free from heart failure-related hospitalizations after 3 years.

It's estimated that the number of people across the world diagnosed with heart failure will increase by almost 50% to nearly 38 million by 2030 and cost upward of $69.8 billion. And, despite significant advances in treatment, mortality post-hospitalization remains at roughly 10% at one-month, and 30% to 75% at one year and five years, respectively.

"We're extremely proud of our incredible heart failure team, and their tireless work to participate in clinical trials and research that aim to advance therapies for patients whose options may be limited," said Stephen Bailey, MD, Chair of AHN Cardiovascular Institute.

For more information on this trial or to see if you may be eligible for enrollment, please call 412-359-4631.

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About the Corvia Atrial Shunt and RESPONDER-HF
The Corvia Atrial Shunt is the most clinically studied atrial shunt for the reduction of LAP in symptomatic HF patients. It has been implanted in over 675 patients worldwide and reviewed in over 30 academic publications. The RESPONDER-HF trial builds on the extensive data and progressive learnings from the REDUCE LAP-HF II clinical trial, the largest randomized controlled trial of device-based therapy in HFpEF. Results showed that within a large responder population, representing 50% of study patients, treatment with the Corvia Atrial Shunt resulted in a 45% reduction in HF events and a 55% greater improvement in quality of life compared to sham control.³ RESPONDER-HF is a randomized, double-blind, sham-controlled trial including up to 260 patients from centers across the US, Canada, Europe, and Australia. Drs. Sanjiv Shah from Northwestern University's Feinberg School of Medicine and Dr. Martin Leon from Columbia University Irving Medical Center serve as co-principal investigators for the study. For more information, visit treatmyheartfailure.com.