Breathing easier: A new heart failure treatment transform’s Sue Ellen’s life

Sue Ellen Bigioni, 70, chose Main Line Health for cardiac care and discovered a revolutionary heart failure treatment. Available at only a few hospitals nationwide, it gave her a fresh start. Today, Sue Ellen is breathing easier and able to actively participate in long-held traditions – and new adventures – with her family.

Worsening shortness of breath after personal losses

Beginning in 2020, Sue Ellen experienced a string of significant and emotional personal losses.

"I lost my brother in August of 2021 and my husband of 50 years, Vince, later that year – three days before Christmas. Then in 2022 I lost another brother in March and my sister on Memorial Day, so it was rough," recalls Sue Ellen.

For years, Sue Ellen had struggled with a number of chronic conditions. These included coronary artery disease, atrial fibrillation (AFib), hypertension, COPD, sleep apnea, lupus and rheumatoid arthritis. Her main complaint was severe shortness of breath, and her symptoms worsened as she grieved the loss of her family members.

"I was in a huge home (four bedrooms, split level, on an acre of land) by myself. I could barely move from one room to another," says Sue Ellen.

She continues with, "I usually stationed myself on the middle level, and I would sit in my kitchen for 20 minutes to a half hour before I attempted to go up the steps to my bedroom."

Difficulty breathing leads to heart failure diagnosis

Medication changes did not improve Sue Ellen's escalating symptoms. Maribel Hernandez, MD, cardiologist at Main Line Health who managed Sue Ellen's cardiovascular care, referred her to Justin Pelberg, DO, a heart failure cardiologist at Main Line Health, for a consultation.

Dr. Pelberg diagnosed Sue Ellen with heart failure with preserved ejection fraction, abbreviated as HFpEF (pronounced “heff-peff”).

What is heart failure with preserved ejection fraction?

In HFpEF heart failure, the muscle of the left ventricle becomes stiff. This prevents the heart from its healthy functions of relaxing and filling with oxygen-rich blood between each heartbeat.

"When you exert yourself and increase the amount of blood circulating throughout your body, a stiff left heart is unable to accommodate this increase in circulating blood. As a result, pressure rises, which is transmitted to the lungs, resulting in patients becoming short of breath," explains Dr. Pelberg.

Since Sue Ellen's specific type of heart failure did not respond well to medical therapies. As a result, Dr. Pelberg suggested she may be eligible to join a clinical trial researching the APTURE device, a new heart failure treatment option.

Groundbreaking treatment for heart failure with preserved ejection fraction

The APTURE device, part of the ALT-FLOW II clinical trial, delivers transformative therapy to patients with HFpEF. Through a minimally invasive procedure, this implanted device creates a shunt (medical diversion) that directs blood flow out of the left atrium of the heart. Instead, the device routes the blood flow into the right atrium through the coronary sinus (veins combined to form a large blood vessel in the heart). In certain patients with HFpEF, this way of decreasing left atrial pressure has been proven to reduce shortness of breath.

"We were first in the United States, and second in the world, to implant this device, and I'm hopeful that ongoing trials will ultimately lead to it receiving Food and Drug Administration (FDA) approval and being widely available for heart failure," says William A. Gray, MD, section chief for cardiovascular diseases at Main Line Health and national co-principal investigator for the ALT-FLOW II clinical trial.

Sue Ellen admits that she was skeptical about participating in a clinical trial. Encouraged by her children, she agreed to undergo the pre-trial testing and discovered she qualified for the procedure.

Improvement one day after surgery

In June of 2024 at Lankenau Medical Center, a Main Line Health facility, Dr. Gray and the heart care team successfully implanted the APTURE device in Sue Ellen's heart. Her breathing almost immediately improved as she was transported to her hospital room to recover.

"I remember being with my daughter, Jennifer. I got up from bed and walked to and from the bathroom, and she said, 'Mom, you're not gasping to breathe!'"

"I recognize that this result may not be seen with every patient, but if we can see this response, or at least a partial response, for some patients we consider for this device, it is a win," says Dr. Pelberg. Sue Ellen was discharged from the hospital one day after her heart surgery.

"I went to my daughter's house to recover from the procedure and had to climb 10 steps to bed, and I was not gasping for air," Sue Ellen recalls.

"I noticed over time it got better and better, and I could do more and more," she explained. "I went for my post-op check-up with Dr. Pelberg, and I was feeling fabulous. He asked me how improved I felt, and I said at least 75 percent."

New heart failure clinical trial brings lasting relief

It's been over a year since Sue Ellen received the APTURE device. She is still living independently, working part-time and enjoying daily walks with her dog, Addie. She is also looking forward to several upcoming family trips: a long-standing annual camping trip at Knoebels, a cruise to Greece and a vacation to Florida. All of which would have been impossible before her heart procedure.

"Sue Ellen is doing great. Our visits used to be very challenging as we were searching for answers and trying to develop a game plan. Now she comes to me and has no complaints. It is a complete turnaround for the better," notes Dr. Pelberg.

"This was my last chance to have a life, and I wasn't ready to give up. I'm so grateful for Dr. Pelberg and the entire team for giving me my life back," says Sue Ellen.

Next steps

Having trouble with your heart? Schedule an appointment with a Main Line Health cardiologist.

Join a clinical trial at Main Line Health for HFpEF or another type of heart failure.

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