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Congenital Heart Disease Expert Implants First-of-Its-Kind Pulmonary Heart Valve Device In an FDA-Approved Clinical Trial

Device Could Reduce Open-Heart Surgeries for Patients Born with Tetralogy of Fallot and Other Pulmonary Valve Defects

Contact Sally Stewart | sally.stewart@cshs.org

Los Angeles — Sept. 13, 2017 — A Cedars-Sinai interventional cardiologist has performed the first minimally invasive procedure using a device that could spare patients with a common congenital heart defect from undergoing multiple open-heart surgeries.

Malformed pulmonary valves are among the most common congenital heart defects and often act as a blockage that prevents the flow of blood through the heart. Babies born with defects such as Tetralogy of Fallot often have a blue tinge to their skin, indicating their blood isn’t getting enough oxygen. Since the 1950s, surgeons have been able to clear the artery, but the repair often results in a leaky pulmonary valve which could require additional open-heart valve surgeries throughout a patient’s life.

"These patients, typically require multiple open-heart surgeries over the course of their lifetime, and in between surgeries, this condition is quietly causing significant damage to their heart that may ultimately result in heart failure and a premature death," said Evan Zahn, MD, director of the Guerin Family Congenital Heart Program in the Cedars-Sinai Heart Institute. "There is a great need to find a solution we hope will yield better results, fewer repeat surgeries – and have patients going home more quickly."

With that goal in mind, Zahn recently became the first interventional cardiologist to give a patient an investigational device called the Alterra Adaptive Prestent, developed by Edwards Lifesciences. The procedure was the first in a new, early feasibility clinical trial that was approved by the FDA. Alterra is a self-expanding, stent-like implant that conforms to a wide range of pulmonary artery anatomies and can be delivered via a small incision in the leg. It is designed to reshape the right ventricular outflow tract (RVOT) of the heart, to provide a "landing zone" for a replacement Edwards SAPIEN 3 transcatheter heart valve.

Zahn’s patient, Cheryl Davis, 48, was the first in the world to receive the device. Born with a malformed pulmonary valve, Davis underwent her first open-heart surgery in 1978, when she was just nine years old. Although successful, the surgery could not completely fix Davis’ pulmonary valve and she was left with a significant leak, requiring close monitoring throughout her life.

Davis, an animation lighting artist, led a healthy and active life, hiking and training to be a yoga instructor. She purchased a home she’s planning to open as a bed and breakfast in upstate New York. But starting about five years ago, Davis began feeling the effects of her worsening pulmonary valve leak.

"I was having more dizzy spells than normal, and more heaviness in my chest," Davis said. "And I was dreading going to the doctor because I knew it meant another open-heart surgery and everything that goes with that – pain, missing work, not being able to do the things I love doing."

But when Davis went to see Zahn, she learned that the device might fix her heart condition without open-heart surgery. She underwent the 90-minute procedure Aug. 22 and went home the next day.

"I’m so excited that this investigational treatment option was available to me," Davis said. "I’m looking forward to getting back to doing the things I love."

Zahn is the lead investigator for the multicenter, national clinical trial sponsored by Edwards. In the past, Zahn occasionally has received consulting fees from the company, but has not received any compensation for the Alterra Adaptive Prestent clinical trial.