PITTSBURGH – On-again, off-again stomach pain had bothered home remodeler Jerome Holiday for more than a year, but in January, it worsened to the point of slowing him down.
“If I was up on a ladder, I would have to come down,” the 59-year-old Pittsburgh resident said. “If I was doing something strenuous, I would have to stop.”
Holiday had a potentially fatal abdominal aortic aneurysm, which doctors at Allegheny General Hospital repaired with an experimental procedure that could prove more effective and patient-friendly than the one that’s standard now.
Allegheny General is one of about 30 sites in the United States, Canada and Europe taking part in a clinical trial of the new technology, developed by California-based Endologix Inc. Holiday, who had the procedure March 4, was the first to undergo the procedure in Pittsburgh.
Dr. Satish Muluk, chief of vascular surgery at AGH and lead investigator of the Pittsburgh study, said the procedure could be revolutionary.
An abdominal aortic aneurysm – a leading cause of death among older patients, the doctor said – is a ballooning of the body’s main artery near the kidneys. Because of the expansion, the artery wall becomes so thin that it ruptures, causing internal bleeding. At that point, the patient faces long odds.
“We estimate the mortality is around 80 percent,” Muluk said, noting many patients have no symptoms before an aneurysm bursts.
Emphysema, genetics, high cholesterol and blood pressure, obesity and smoking are among the factors believed to contribute to aneurysms, according to the National Library of Medicine. Men are more prone than women.
However, the problem can be detected ahead of time with an ultrasound, which is part of the covered package of care for new Medicare enrollees. The Medicare years are when the aneurysms are most likely to develop, Muluk said.
Muluk said Allegheny General repairs about 150 of the aneurysms annually. The standard treatment, developed in the late 1990s, is minimally invasive endovascular surgery in which a stent, shaped like an inverted Y, is inserted to bypass the damaged section of aorta.
But 15 percent to 20 percent of patients later require another procedure because their stent moves or blood leaks into the aneurysm.
The new procedure involves the insertion of two stents – one to circulate blood in each leg – inside the aneurysm and the inflation of two polymer-filled bags to fill up the rest of the swollen area. The technique is designed to hold the stents in place and prevent blood leakage.
In short, whereas the standard procedure bypasses the aneurysm, the new procedure “obliterates” it, said Dr. Jeffrey Carpenter, global principal investigator for the trial and professor and chairman of surgery at Cooper Medical School of Rowan University in Camden, N.J.
So far, 24 trial participants have undergone the procedure. Each case has been technically successful, without complications, Carpenter said.
“It’s a very simple procedure, much simpler than one we currently do,” and it’s likely to help a larger, more diverse group of patients than is medically eligible for the standard repair, he said.
The trial procedure takes about 90 minutes, compared to the two hours or so needed for the standard treatment, and has the potential to be done on an outpatient basis, Muluk said. Participants in the trial, however, are spending one or two days in the hospital.
The new repair also has the potential to be done under a local anesthetic instead of the general anesthetic used in the standard procedure. Carpenter said he recently used a local while performing the repair on a 90-year-old man.
Holiday, who also has a heart condition, said he isn’t sure when he might be able to return to work.
Muluk said patients undergoing the standard or new treatment for repairing the aneurysms generally are able to resume regular activities.