A 54-year-old West Michigan woman was the first in the world to undergo a minimally invasive procedure to create a permanent opening between two chambers of her heart using an experimental stent-like device developed by a cardiologist at Spectrum Health.
Pulmonary hypertension is a lung disorder in which the blood pressure in the pulmonary artery rises far above normal levels. This puts extra strain on the heart because it has to work harder to pump blood and can lead to heart failure.
Pulmonologists and cardiologists had been managing the woman’s condition medically until it became apparent that some kind of intervention was needed.
“She was no longer responding well to medications and her condition was worsening,” he said. “She was extremely weak and short of breath, she had a swollen abdomen and extremities, and her heart was failing.”
Vettukattil said it was critical to find a way to reduce the pressure in her pulmonary arteries and the strain on her heart.
“The best way to do this was to create a permanent channel for a controlled flow of blood between the right and left atriums of her heart,” he said. “She wasn’t a candidate for surgery so we decided a procedure in the cath lab to place the stent was her best option.”
So far, the woman’s recovery has been remarkable.
“She’s getting around much easier and says her quality of life has greatly improved,” Vettukattil said. “In addition, the swelling in her abdomen and limbs is gone.”
The device was developed by Vettukattil when he was working in England. It is manufactured in Turkey and does not have Food and Drug Administration approval for use in the U.S.
“Not having FDA approval was a challenge,” Vettukattil said. “However, our clinical staff worked closely with experts from throughout the Spectrum Health system to get permission from the FDA to bring the stent into this country for a one-time compassionate use.”
The next step in development of this device is coordinated investigational studies of its use and performance.