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February 23, 2014

Alternative to open-heart surgery to replace aortic valve available at Mon General

MORGANTOWN — Mon General Hospital has a new option for patients who need aortic valve replacement but aren’t healthy enough for open-heart surgery.

While traditionally open-heart surgery was the only option, Transcatheter Aortic Valve Replacement (TAVR) allows doctors to go in and replace the aortic valve without opening the chest or stopping the heart.

Instead, they go in using a tiny device that is inserted through a groin vessel or a small two-inch incision. The new artificial valve is then inserted within the diseased valve.

The procedure gives patients who have been diagnosed with severe symptomatic aortic valve disease, but aren’t well enough for traditional open heart surgery, the option of surgery to replace their aortic valve­ — an option they did not have before TAVR was approved by the FDA in 2011.

Mon General is the first hospital in North Central West Virginia to offer this procedure.

Dr. Alexander Nagy, the medical director of cardiothoracic surgery at Mon General, explained that the health of the aortic valve is very important to the body.

“It is one of the four valves of the heart that basically is a gate keeper between the main chamber of the heart and the main highway for the blood, which is the aorta,” Nagy said. “That’s the source of oxygen and nutrients for the entire body.”

So when the aortic valve doesn’t work properly, it can cause serious problems.

Aortic stenosis is when the aortic valve can’t open wide enough, which makes the heart work harder to push the blood into the aorta. The heart can compensate for a few years, but eventually, it gets tired of being overworked.

“After several years symptoms occur, including chest pain, shortness of breath and loss of consciousness,” Nagy said. “Unfortunately, when the patients become symptomatic the life expectancy is limited, and approximately half of them die within the next two years.”

Open-heart surgery has a very good success rate of 99 percent for patients at medical centers like Mon General.

But not all patients are healthy enough to undergo open-heart surgery.

“There is a significant number of patients with severe aortic stenosis who are either inoperable or at a very high risk for surgery because of their age or other medical problems,” Nagy said. “And for that percentage of patients, which is up toward 30 percent, there is no option basically.”

With TAVR, these patients are now, for the first time, able to get their aortic valve replaced.

“Now you can treat those patients, the 30 percent who are elderly or very sick, with a technology that, to me at least, is the ultimate minimally invasive approach,” Nagy said.

The two companies that pioneered the transcatheter valve are both American companies. However, while the procedure was approved in Europe in 2007, it wasn’t approved in the United States until 2011 for inoperable patients, and in 2012 for high-risk patients.

50,000 cases were performed in Europe between 2007 and 2012, with excellent results, Nagy said.

Nagy said that prior to FDA approval, two rigorous studies were done that verified the value of the procedure. The first showed that TAVR was a better option for patients than medication alone. The second showed that TAVR performed as well as open-heart surgery.

So far, Mon General has had three TAVR patients, with two procedures in November and one in December. Five more are on the waiting list.

And while it is currently only approved for high-risk patients, Nagy said he sees approval down the road, once they can see the long-term results.

The TAVR procedure requires a much bigger staff than traditional open-heart surgery. While in open-heart surgery there are only two doctors, in TAVR, there are six. Including technicians and nurses, Nagy estimates there are at least 20 people involved in the operating room during a TAVR procedure. With so many people, it’s important for everyone to work together.

“So you have to create an orchestra, a team,” Nagy said. “It becomes like a symphony.”

All of the work is worth it, though, Nagy said.

“This type of surgery is done for patients who have severe aortic stenosis, not moderate,” Nagy said. “So first of all, you want to save their life, because they don’t have another option.”

Nagy said that, provided they have no other severe health conditions, such as kidney disease, patients who have undergone TAVR should be able to lead normal lives.

“Their lifestyle should be very similar with somebody who has no aortic valve problems of the same age,” he said.

Pearl Walls, 85, of Granville, said that the surgery has made a difference in her life.

“I think it did me a world of good to have it done,” Walls said. “I think they did a really good job because I haven’t had any problems at all from it.”

Walls said she was in the hospital for around a week following the procedure.

She said she’s been pleased to live as long as she has so far, and is looking forward to her 86th birthday in October.

“I used to think I wouldn’t live to be 50. Well, I made it to 50 and then some,” Walls said.

Email Colleen S. Good at cgood@timeswv.com or follow her on Twitter @CSGoodTWV.

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