Permanente Medicine in Action

What to Know About TAVR, an Alternative to Open-Heart Surgery

U.S. News & World Report – September 18, 2017

Pat Marble noticed that she could no longer sing or whistle. The active then-104-year-old was having trouble breathing, and her family insisted she go to the doctor.

It turned out Marble’s aortic valve – which brings blood from the heart to the body – was wearing out, a serious condition called aortic stenosis. She needed a new valve, but because of her age, she wasn’t strong enough to undergo anesthesia and have open heart surgery, the gold standard treatment for a new valve.

So doctors recommended a procedure called transcatheter aortic valve replacement, or TAVR, that would allow surgeons to give her a new aortic valve by threading a catheter through her groin without opening up her chest. She would be awake during the procedure, a prospect that didn’t scare her. “I agreed,” says Marble, who recently celebrated her 105th birthday. “When you get over 100, you take each day at a time.”

TAVR Vs. Open Heart Surgery

The TAVR procedure, also known as TAVI, has been performed in the United States for about five years. It’s approved for and often used by people who are too weak or fragile to have open heart surgery; most patients who undergo TAVR are in their 80s. As its use expands – last year, it eclipsed traditional open heart surgery – doctors are investigating the long-term effects of the minimally invasive procedure, as well as whether it’s also appropriate for people who are eligible for open heart surgery.

Traditional open heart surgery is a several-hour procedure that requires general anesthesia and involves opening up the chest plate to cut out the old valve and sew in a new one. Recovery is often a week in the hospital, and most patients don’t resume a normal lifestyle for several more weeks or even months.

During TAVR, meanwhile, a catheter threaded from the groin places a new valve in the heart, expanding the new valve and displacing the faulty one. Patients are generally lightly sedated, but are awake and can talk during the procedure, which takes 30 minutes. Recovery typically consists of a day or two in the hospital, and patients can often resume normal activities soon after.

“It’s amazing to watch somebody who can’t go up a set of stairs, and you see them in the office two weeks after TAVR, and they’re active and exercising and walking around,” says Dr. Edward McNulty, medical director of cardiac services for Kaiser Permanente Northern California, which performs about 300 TAVRs a year. “It’s a dramatic improvement in quality of life.”

Marble’s TAVR was performed at Abbott Northwestern Hospital in Minneapolis, near her home, in January. Doctors talked with her during the whole procedure, explaining what was going on and reassuring her, she says. She was home two days later and says the procedure has given her a new lease on life as she continues quilting, making glass lamps and raising and butchering chickens. “There was nothing to the recovery,” Marble says. “Today I feel like I’m 75, except my knees won’t work. Other than that, I’m fine.”

Expanding TAVR’s Use

TAVR was originally approved for patients like Marble, too high-risk for open heart surgery because they are frail or have lung disease or other conditions that make surgery dangerous. Last year, the Food and Drug Administration approved it for intermediate-risk patients – those who have a greater than 3 percent risk of dying within a month of surgery.

Doctors say TAVR solves a major problem for cardiac patients, because aortic stenosis – the condition Marble was diagnosed with – typically occurs in patients in their 80s, who aren’t eligible for open heart surgery. “Many of these patients in their 80’s and 90’s, we were sending them to hospice,” says Dr. Paul Sorajja, a cardiologist at Minneapolis Heart Institute at Abbott Northwestern Hospital and director of the Center of Valve and Structural Heart Disease at Minneapolis Heart Institute.

While the number of TAVR procedures performed each year continues to grow quickly, the number of open heart surgeries remains about the same, meaning TAVR is being performed on a population that likely wouldn’t have had surgery if not for this alternative option. In 2016, there were about 37,000 TAVRs, compared with about 28,000 standard aortic valve replacements, according to a study presented at the 2017 Trans Catheter Therapeutics Meeting in Chicago.

And the number of TAVRs could expand more in the future. Several clinical trials are exploring whether TAVR is effective for people who are low-risk for open heart surgery, meaning someday it could be available to all patients. “Every patient on the planet Earth would rather go through a procedure that is less invasive and has a shorter recovery if the results will be just as good,” says McNulty, who is one of the site investigators for a clinical trial sponsored by Edwards Lifesciences, a company that manufactures the implantable valves.

Durability of the Valves

Doctors are still figuring out how the valves last over time – the clinical trial McNulty is involved with is following patients for 10 years – and how patients fare if they have TAVR and then need to undergo it again in the future because the valve fails. “Durability is a valid concern,” McNulty says. “We have very limited experience putting a second TAVR valve inside a TAVR valve or a surgical valve. There are some signals that the durability of that procedure may not be as good.”

TAVR valves, made from cow or pig tissue, have been found to last at least five to seven years, McNulty says. In open heart surgery, valves are either made of tissue – in which case they last around 10 years – or metal, which lasts 20 to 25 years.

The Risks

In both TAVR and open-heart surgery, about 25 percent of high-risk patients died within one year, according to a study published in the New England Journal of Medicine in 2011. The study also showed that about 5 percent of TAVR patients had a stroke within a year of the procedure, compared with about 2 percent of patients who had a stroke after open heart surgery. Additionally, a report published in the American College of Cardiology in January indiciates that up to 25 percent of TAVR patients needed a pacemaker implanted after the procedure.

Despite the risks, some younger people are eligible for TAVR and opting for it. Twice this year, Sorajja performed TAVR on pregnant women whose valves were failing, but who did not want open heart surgery because it would have been a danger to their babies. Both women have since given birth to healthy babies; they’ll likely need to replace their valves in about five or so years, Sarajja says.

Marble, meanwhile, says she knows three people who had TAVRs after she did. But she is a modest woman and says she doesn’t want to be called an “inspiration.” “They saw it being done on a 104-year-old woman, and they thought they could do it, too,” Marble says, adding that her secret to longevity is smiling and making people happy. “At this age, there’s not much you want except good health. If you can make somebody else a little happier, a little better, that’s our place.”

This article first appeared in US News and World Report