Patients with congenital heart conditions that disrupt blood flow from the heart to the lungs now have access to a new, minimally invasive treatment option at University of Iowa Health Care. The treatment reduces the number of open-heart surgeries these patients need during their lifetime.

UI Health Care is the first and only hospital in Iowa to offer the Harmony transcatheter pulmonary valve system that can repair severe pulmonary valve regurgitation (blood leaking backward into the right lower chamber of the heart), without using the traditional approach of open-heart surgery. The device was approved by the FDA in spring of 2021.

Osamah Aldoss holding Harmony valve

“This new treatment will serve a lot of patients that didn't have a less invasive option before,” says Osamah Aldoss, MD, clinical associate professor of pediatrics-cardiology with UI Health Care. “The standard of care before this valve was surgical correction, which required the chest to be opened and the patient placed on a heart-lung bypass machine. This type of invasive surgery typically requires five to seven days of hospitalization and a long recovery time. With this new valve procedure, you avoid all that because it is minimally invasive.”

The Harmony valve, which is placed into the heart through a long tube (catheter) and threaded into position from the groin, takes only a few hours, typically requires an overnight hospital stay, and has a much shorter recovery time than the traditional open-heart surgery approach.

Two groups of patients, in particular, will benefit significantly from the new treatment, according to Aldoss. The device is especially useful for patients born with Tetralogy of Fallot, one of the most common congenital heart defects, which involves a combination of four heart defects including a hole in the heart that reduces blood flow to the lungs. Invasive surgery during infancy can correct this problem but leaves the patient with a leaky pulmonary valve.

The other group who can benefit from the new approach are people born with pulmonary valve stenosis that was treated with a balloon valvuloplasty early in life and have developed a leaky pulmonary valve.

In the past, a leaky pulmonary valve was considered relatively benign. But over the past couple of decades that thinking has changed as more evidence suggests that a leaky valve can worsen heart performance, causing irregular heart rhythms and even heart failure. Physicians have become more aggressive in trying to form a more competent valve for affected patients. In addition to being a minimally invasive option, the self-expanding Harmony valve is also larger than previous devices so it can cover much larger anatomy in addition to the unique design that makes it a safer procedure.

Harmony valve

“It's unique because it's going to treat a large portion of congenital heart disease patients who were not a candidate for the previously existing cath-based valves,” Aldoss says. “There are more adults now with congenital heart disease than kids, so I think this device is really going to be important in the future because there's going to be so many patients that can benefit.”

Since congenital heart disease is a lifelong problem, it is important for patients with any congenital heart defect to receive lifelong care. University of Iowa Hospitals & Clinics is the only facility in Iowa to follow children with congenital heart disease into adulthood and treat patients with chronic conditions who might need more serious treatments like transplant or catheterization procedures, like the new Harmony valve.

University of Iowa recently earned accreditation from the Adult Congenital Heart Association (ACHA), a nationwide organization focused on connecting patients, family members, and health care providers to form a community of support and a network of experts with knowledge of congenital heart disease.