TAVR and the million-dollar man

TAVR

 

By Melanie Medina

 

John Murray’s house on the Outer Banks of North Carolina is built 10 feet off the ground. So when he began losing his breath climbing the 20 stairs to his front door, he knew it was time to do something.

“As soon as I’d get to the top of the steps, I’d have to sit down,” John, 72, says. “My biggest concern was that I could hardly breathe.”

Shortness of breath is the most common symptom for what John has: a valve disease called severe aortic stenosis (AS). The condition happens when the leaflets of the heart’s aortic valve becomes so stiff that blood doesn’t flow easily through the heart and body. It can also cause fatigue, lightheadedness, heart failure and even death.

An estimated 2.5 million people in the U.S. over age 75 — a little more than 12 percent of the population — have this valve disease. When John heard his diagnosis, he asked his doctor, “Am I ready to die?” “No need to call the undertaker yet,” his doctor answered.

When John was first diagnosed, his aortic stenosis was mild. His cardiologist regularly monitored his valve over the course of a few years, until it progressed to the point where the valve needed to be replaced. John’s doctors offered him three options: He could have open-heart surgery so doctors could replace his aortic valve.

He could have a minimally invasive surgery, which would, like open-heart surgery, require him to be on a heart-lung bypass machine temporarily during the operation. Or he could have a less-invasive procedure called transcatheter aortic valve replacement (TAVR), which doesn’t require open-heart surgery or going on bypass.

During a TAVR procedure, doctors make a small incision, usually in the groin area of the leg, and insert a catheter through an artery. The catheter is threaded up to the heart and into the aortic valve, where doctors place a new valve inside the diseased one.

TAVR has been shown to offer eligible (intermediate risk) patients a safer option with potentially better outcomes. Also, recovery is faster, average time in the hospital is shorter and most patients like the idea of not having their chest opened up.

John and his wife weighed their options: a painful surgery, possibly up to two weeks in the hospital and a slow recovery time versus a less invasive alternative requiring only up to a few days in the hospital with a speedier recovery and less pain. The Murrays hoped he could go the TAVR route.

The Iceberg Phenomenon

John’s health situation isn’t uncommon, and as the population ages, more of us can expect to face valve diseases like aortic stenosis. Between now and the year 2050, the elderly population in the U.S. is expected to double.

Despite the number of patients living with the disease and the fact that treatments are available, studies show that valve disease is undertreated. At least 40 percent — perhaps as many as 60 percent — of patients with severe aortic stenosis do not receive valve replacement.

“It’s tough to pin down absolute data on it, but certainly every estimate that I’ve seen is there are more people not being treated than treated,” says Christian Gring, M.D., a cardiologist at UNC Rex Healthcare in Raleigh, North Carolina. “There is this iceberg phenomenon where we’re treating a relatively small percentage of patients.”

Why? Researchers suggest a number of possible reasons. Some patients aren’t properly diagnosed with severe aortic stenosis. Others overestimate the risks of treatment and choose not to treat their valve disease, not being aware of the greater risks of leaving it untreated. And many shrug off their symptoms, thinking they’re part of the aging process.

“It’s not to say that every patient with severe aortic stenosis ought to have a valve intervention,” he says. “But we want to identify people whose stamina has decreased, who get tired faster getting dressed, going for their morning walk or taking their dog out. Because even when they have mild symptoms, we know that there is clinical benefit to going in and fixing things.”

Family Feedback

Once a patient decides he or she wants to treat their valve disease, they need to be aware of all of the available options.

“With TAVR, our goal is to make sure patients understand what their valve is, what they can expect if we do nothing and what the options are to fix the valve,” Dr. Gring says.

After the onset of symptoms, if nothing is done, patients with severe aortic stenosis have a survival rate as low as 50 percent at two years and 20 percent at five years.

“The healthier people are, the easier it is to get through that discussion. But the frailer and older people are, you really have to balance what their expectations and their goals are, and what their quality of life is,” Dr. Gring says.

That said, there isn’t an age cut off for TAVR. “Our oldest patient was 99, and she did great,” he adds. The TAVR eligibility criteria is based on risk, not age. Currently, high-risk and moderate/intermediate risk patients are considered for TAVR procedures. Clinical trials for low-risk patients are being completed across the country in multiple institutions with results coming soon.

Quality-of-life considerations often involve the patient and close family members. “Valve disease is such a gradual, insidious process that many patients don’t even notice that they’re slowing down,” Dr. Gring says.

That’s why he likes asking spouses or children to weigh in. “It’s not infrequent at all that the family will tell a different story and say, ‘My dad used to be really active up until six months ago. He was walking every day and now he doesn’t do it.’”

When John and his wife, Sherry, also 72, were considering treatment options, quality of life was a big factor. “We go to Planet Fitness, and everybody tells us we look like we’re 52,” John says. “We’re very active, and I love to fish. I’m on the water, in the water or under the water 90 percent of the time.”

The Murrays weren’t thrilled at the thought of John slowing down and recuperating for several weeks after open-heart surgery, if he had to go that route.

Post-Treatment

After several tests and discussions with his doctors, John was convinced that TAVR was the right option for him. He asked a lot of questions and shared his concerns, preferences and values with his heart team to ensure that they came up with the right plan for his unique situa- tion and needs.

“We went in on a Thursday morning, and at 7:30, I was in the operating room. At 9:30, I was back in recovery. At 10:30, I was back in my room. The next day at noon, I went home,” John recalls.

When asked how he feels now, John is quick to answer. “I feel like a million-dollar man,” he says. “It’s phenomenal. Immediately, the very next day, I could breathe. I could walk and not get out of breath.”

He shares his story frequently with other Mended Hearts patients who have valve disease. Mended Hearts recently launched a peer-to-peer support network and visiting program specifically to address the unique needs of patients who have elected to undergo a TAVR procedure. As a member of Mended Hearts and the TAVR visiting program, John has helped several others considering treatment with TAVR. Like others in the visiting program, he listens to patients’ concerns, shares his experiences and stresses the importance of being informed about all potential options and making good treatment decisions with the help of their doctors.

Mended Hearts President Donnette Smith adds that “in our nearly 70 years offering the gift of hope to heart disease patients and families, the Mended Hearts mission is — and always has been — to educate and support heart patients, caregivers and family members through programs that put the patient’s needs as our sole focus. We do not offer medical advice to patients or advocate for specific procedures, medications or treatments.”

TAVR Trials

Patients like John, along with physicians and other clinicians familiar with the benefits of TAVR, are working to ensure that all Americans facing valve disease have access to whatever procedure is appropriate for them. But they definitely have some roadblocks.

To understand those roadblocks, it helps to have some context of TAVR in the U.S. After initial clinical trials, researchers found that in terms of major clinical outcomes, TAVR was similar to surgical aortic valve replacement in high-risk patients.

So, in 2011, the U.S. Food and Drug Administration (FDA) approved TAVR for inoperable patients, and later for high-risk patients. Clinical trials for low-risk patients are being completed across the country in multiple institutions with results coming soon. It is very possible that the FDA may make TAVR available to low-risk patients in 2019.

“As the technology improved, bleeding risk, vascular complications and mortality have clearly gone down, as have stroke rates,” Dr. Gring explains. “These improvements ultimately led to approval in intermediate-risk patients.”

Now, several trials are underway for other types of patients. The EARLY TAVR (Evaluation of Transcatheter Aortic Valve Replacement Compared to Surveillance for Patients with Asymptomatic Severe Aortic Steno- sis) trial is comparing two groups of asymptomatic patients: those who receive TAVR vs. those who undergo clinical surveillance.

And the TAVR UNLOAD trial focuses on patients with heart failure who have moderate aortic stenosis. The study will compare the efficacy of TAVR and the use of optimal heart failure therapy vs. optimal heart failure therapy alone. (Optimal heart failure therapy is defined as medication only or a combination of medical therapy and approved heart failure devices as directed by medical guidelines.)

Visit clinicaltrials.gov for more information on these studies.

Medicare’s Role

As trials studying TAVR efficacy continue, the Centers for Medicare and Medicaid Services (CMS) is re-evaluating the TAVR requirements and reimbursement policy. When the original Medicare policy was established in 2011, it set a high bar for TAVR in regard to reimbursing hospitals and providers for the procedure. In order for Medicare to cover TAVR, hospitals had to show that they cared for a certain volume of high-risk valve disease patients.

The requirements also stated that an interventional cardiologist and two heart surgeons had to independently examine a patient to evaluate whether he or she was suited for TAVR. In addition, it required TAVR patients to be under the care of an integrated team of health care providers that specialized in the treatment of valve disease.

“It wasn’t just going to be a surgeon  or a cardiologist making the decision, but rather a team of imagers, anesthesiologists, cardiovascular surgeons and an interventional cardiologist who all consider the patient and try to figure out if they’re better off getting a surgical or a transcatheter valve,” Dr. Gring says. At the time, this team approach was relatively new in cardiology, he says.

In June of 2018, CMS announced that it would reconsider its TAVR requirements and reimbursement policy, which could potentially widen or limit patient access to TAVR. Mended Hearts has played a critical role during this reconsideration process.

On July 25, Mended Hearts President Donnette Smith delivered a presentation at CMS’s Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) meeting. Donnette brings a unique and credible perspective, as she is a heart valve patient herself and an experienced patient advocate.

Donnette explained to the committee that the current policy creates barriers to TAVR. She also noted that using case volume (instead of quality outcomes) may restrict TAVR access. Case volume requirements also mean that a patient’s treatment at one hospital can be vastly different from the treatment they would have received at a different hospital.

Donnette also consistently stressed that “we always encourage patients to make medical decisions based on their individual needs and discussions with their doctor. Mended Hearts is uncompromising in our belief that the medical decisions a patient makes must be based on the individual needs of that patient and that the course of action taken will be determined solely by that patient and his or her medical team.”

Results of CMS’s re-examination of its current TAVR policy are expected in the first half of 2019. Dr. Gring, for one, hopes the results will be positive for patient access to TAVR.

“The idea that TAVR is going to be utilized less frequently in the future — I don’t think is going to happen. I think it’s just going to continue to grow,” he says.

You Have a Say

It’s not only important for patients to advocate for themselves and their loved ones when it comes to their personal care, it’s also vital that they recognize the important voice they have when it comes to patient-centric policies.

Patients can make a real difference when it comes to important healthcare issues that can impact shared decision-making and access to treatments. Above all, patients should have access to the treatment that is right for them — whether that is surgical, interventional or medical — based upon the primacy of the physician-patient relationship.

While legislators review the policy and researchers continue clinical trials, patients have many ways to get involved in the discussion. For starters, if you’ve had the procedure, consider participating in the Mended Hearts TAVR support network. Watch a recent webinar on the importance of shared decision-making in the evolving treatments for valve disease (mendedhearts.org/webinars).

You can also help raise awareness by participating in National Heart Valve Disease Awareness Day on February 22. The annual campaign, which you can learn more about at ValveDiseaseDay.org, offers a number of ways for people to contact their legislators or share their stories about valve disease and the importance of having access to all appropriate and proven treatments.

And if you’ve had treatment for valve disease, be sure to share your story with others who might be facing it. After all, sharing stories is what Mended Hearts is all about, John says. “It would tickle me to death to talk to everybody that’s got to have this. I’d love to tell them my experience and just how good I feel.”

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