Robert Shanahan needed surgery only twice in his life coming into this year, once to remove his tonsils when he was young, the other more recently when he needed a stent to open one of his blood vessels.
That changed in January, when his cardiologist discovered that his aortic valve had narrowed so badly it would need to be replaced.
Shanahan and his wife, Patricia, met with a team at the Catholic Health Heart Center to discuss options, including a relatively new procedure called transcatheter aortic valve replacement (TAVR).
“They started with talk about open heart surgery and I was not happy with that one,” Shanahan said. “Then we talked about other things. We finally got down to TAVR and everybody agreed – especially me.”
Shanahan, 82, underwent the minimally invasive procedure in February. Doctors feathered a prosthetic valve along a catheter through his circulatory system, positioned it into place near his heart, and popped it open.
He spent a day in the hospital and within weeks was tackling jobs around the house he hadn’t dared try in years.
Since its development in 2011, the transcatheter aortic valve replacement procedure has been available to patients unlikely to survive open heart surgery. About two years ago, it became an option as well for those like Shanahan with moderate health risks. More patients started to clamor for it after a landmark research study concluded earlier this year that most low-risk patients stand to benefit as much, or more, from the minimally invasive procedure than traditional open chest valve surgery.
The federal Food and Drug Administration is expected to approve the procedure for those patients by fall. Meanwhile, heart specialists in Buffalo and across the country brace for greater demand as word spreads about TAVR effectiveness for most patients – including a rock legend.
Mick Jagger had the procedure after the Rolling Stones announced in late March that its upcoming tour would be postponed because its 75-year-old frontman needed heart valve replacement surgery.
On April 5, Jagger tweeted a message that he was on the mend from a TAVR procedure. He tweeted a video on May 22 that showed him breezing through his dance moves. The Stones were back on-stage June 21 in Chicago.
“The conversation about aortic stenosis has changed completely in the last couple of months,” said Dr. Vijay Iyer, an interventional cardiologist at the Gates Vascular Institute on the Buffalo Niagara Medical Campus, where the procedure also is performed.
Dr. Stephen Downing – the cardiothoracic surgeon at the Catholic Health Heart Center at Mercy Hospital in South Buffalo who performed Shanahan’s procedure – urged those in need of aortic replacement surgery to talk about the benefits and risks of TAVR with their medical providers. The technology is new, he said, and the potential lifespan of the new valves unknown, though prospects for the vast majority of patients looks very promising.
Years in the making
Kaleida Health specialists now at Gates Vascular Institute performed the TAVR procedure 28 times in 2011 on the Medical Campus during late-stage research trials. The team handled 376 procedures last year and is on pace to do more than 400 this year.
“As people get older, valve diseases are pretty common, and we have an aging population,” said Iyer, a clinical associate professor in the University at Buffalo Jacobs School of Medicine & Biomedical Sciences. Before 2011, he said, half of those with severe aortic stenosis – or narrowing – weren’t getting treated because the condition is typically a disease of the elderly and many had other serious health conditions that made open chest surgery too risky.
The TAVR procedure – which can be performed through a tiny incision in the groin, under the shoulder, along the rib cage, or even through a carotid artery in the neck – was created to provide an option for such patients.
Specialists at the Heart Center started doing the procedure in 2015. Two years later, it was also federally approved for intermediate-risk patients.
The timing worked well for Shanahan, a commercial truck driver and maintenance worker in Buffalo before he and his wife, Patricia, a Marine Midland bank employee, retired and moved to Arcade two decades ago. The couple celebrated their 62nd wedding anniversary late last month.
Several years ago, Shanahan’s primary care doctor heard a murmur in his heart and sent him to a cardiologist, who ordered an echocardiogram and CT scan, which detected a narrowing aortic valve.
The valve works to full efficiency when it opens to the size of a quarter, sending oxygenated blood from the heart to nourish other parts of the body. When the valve opening narrows to the size of a dime, the heart must work harder to pump blood to the rest of the body, raising the risk of congestive heart failure and, without intervention, death.
There are no drugs to address this narrowing and no medical treatment short of surgery that prevents a valve from continuing to slowly narrow once it starts, said Dr. Joseph Gelormini, an interventional cardiologist at the Heart Center.
Symptoms of aortic narrowing can include fatigue, shortness of breath and sharp drops in blood pressure, as well as chest pain, passing out and heart failure.
TAVR has made aortic valve replacement more accessible across the lifespan.
“The oldest person I've done was 102 and was functioning,” Iyer said. “She died four years later of a stroke. It is not uncommon for us to do 90- and 95-year-olds, as long as they can interact socially. It improves the quality of life. It reduces their chances of becoming dependent. It's really changed the landscape of how we look at older individuals and say, ‘What do we do for them?”
The need for valve replacement tends to peak in patients in their 60s and their 80s, Downing said, but can strike at any age for genetic and lifestyle reasons.
“Once you have severe narrowing, if you don't treat it over the course of two years, half the people will pass away,” Downing said. “That's why it's worth going to see your primary care doc at least once a year.”
A changed atmosphere
Shanahan visited Mercy Hospital in January and was assessed at intermediate risk for surgery. He talked with the Mercy heart surgical team – which included Downing, Gelormini and other specialists on their surgical team – and learned he was a good candidate for TAVR.
“Anything you had to ask them, they would give you a nice, honest answer,” Shanahan said. “They wouldn't try to avoid the question or anything else. They were one of the best groups I've ever run into with questions.”
Downing explained the risk categories:
- A low-risk patient would be 65 or younger with aortic valve narrowing and no other medical problems.
- An intermediate risk patient would be in their 80s, with perhaps one or two blockages in a coronary artery, as Shanahan did, or another medical condition.
- A high-risk patient would be a bit older, with more medical complications.
It may seem ironic that the transcatheter procedure once was available only to the highest-risk heart patients, Iyer said, “but in 2011, nobody really knew how well this was going to do over the long term.”
The Center for Medicaid & Medicare Services mandates that a team of specialists advise a patient in need of aortic valve surgery of their options after a thorough health exam that includes images of the damaged valve. A consensus recommendation is given, though the patient has a right to choose an option.
An interventional cardiologist and cardiac surgeon are required to operate together; the first typically handles access into the blood vessel – which almost always goes through the groin – and the second generally advances and deploys the artificial valve.
The new valve arrives in compressed form, inside a pencil-sized cartridge carried into the aorta. The surgeon places it inside the worn, narrowed valve and deploys it. The new valve expands, crushing the old valve and pinning itself into place inside the blood vessel.
“If you’ve got some calcium buildup – which is common in older patients – these valves will anchor very nicely right into that,” Downing said.
The valve is about an inch in diameter, with a metal frame and leaflets made from the outer covering of a cow or pig’s heart – as opposed to longer-lasting metallic valves used during open cardiac procedures.
Shanahan was among recent patients that benefited from tiny nets that catch stray calcium dislodged during the procedure so they can’t cause problems in the neck and brain.
“If everything goes well, patients don't go to an ICU anymore,” Iyer said. “They go to a recovery room, and from the recovery room they go to their room. And the next day, if they don't have any problems, they go home.”
That’s what happened with Shanahan.
“Before the surgery, I didn't want to get up in the morning,” he said. “Now I get up at six, seven o'clock and I'm getting a lot more done.”
He put a new floor in one of the bedrooms in his house – and painted the walls. He built two new gates for his wife’s garden. He and Patricia Shanahan take regular walks through the nearby village.
“I've got a driveway that’s 270 feet long,” Shanahan said. “When I had to take a week’s worth of garbage out to the curb, I used to come back panting. Now I don’t even huff.”
Not for everyone
Because Gates participated in the low-risk research study, they already can offer TAVR to low-risk patients. The Catholic Health Heart Center plans to make it available as soon as the FDA grants approval.
Last year was the first year the number of transcatheter aortic valve replacements exceeded open surgical valve replacements in the United States. Heart doctors in the region predict the tilt toward TAVR will grow from there.
Each valve alone costs about $20,000, Downing said, though Edwards Lifesciences and Medtronic, who have cornered the market, will face more competition in the years to come, which should bring costs down.
Still, he and fellow specialists said TAVR won’t be right for everyone.
Patients who need coronary bypasses – particularly those that can’t be address with stents – as well as an aortic valve replacement will be among those who often will need open cardiac procedures. Others who need a mitral valve replaced with an aortic valve are likely to find themselves in the same circumstance, the specialists said.
“These decisions are based on what is best for the patient, and it depends upon patient anatomy and patient choice,” Iyer said. One piece of good news for those who aren’t TAVR candidates: Incisions used for open surgeries are much smaller, and the healing time shorter, than in decades past.
The biggest quandary will remain what to advise patients who are younger and must decide between an open surgery with a metallic valve already shown to last at least 15 years versus a minimally invasive procedure where a valve might last only half that long.
Heart specialists already know they can do a TAVR “valve-in-valve” procedure once – doubling the lasting power – and said that the latest valves appear to be more durable, but only more time will tell, and open surgery may not be an option for patients who reach the end of the TAVR road.
“Unfortunately,” said Iyer, “there’s nothing [in heart surgery] with zero risk.”