News of two large clinical trials that suggest
transcatheter aortic valve replacement (TAVR) could benefit a wider group of patients with severe aortic stenosis
brought attention last week to Boulder Community Health’s Structural
Heart program and director
Dr. Srinivas Iyengar, who was quoted in a March 16 article in the
Wall Street Journal.
The New York Times also published a positive article that day, stating that research showed
TAVR "proved effective in younger, healthier patients."
To read the full text of the WSJ article, scroll down or
click here (subscription required).
To read the full text of the NYT article,
BCH's Boulder Heart is the only program in Boulder County performing
TAVR, an innovative, minimally invasive procedure to replace failing aortic
valves. Dr. Iyengar leads the most experienced team in Colorado -- with
over 1,000 TAVR procedures performed by himself and
Dr. Daniel O'Hair
"Boulder Community Health has established itself as leader in the
community not only by investing in TAVR technology but also in the skill
and experience needed to deliver the leading-edge care that our community
deserves," says Jeffrey Reed, executive director of Specialty Services
at BCH. "Dr. Iyengar brings hundreds of cases under his belt -- not
just TAVR, but also minimally invasive procedures like Watchman, Mitraclip
and PFO closures. In addition, with our world-class cardiothoracic surgery
team headed by Dr. Daniel O'Hair and
Dr. Bryan Mahan, BCH is poised to take cardiology care to the next level and beyond."
Since the FDA first approved TAVR in 2011, it has been reserved mostly
for patients whose age or physical condition disqualify them from having
open heart surgery. Access to TAVR also has been generally limited to
larger hospitals that perform more procedures each year, due to rules
and reimbursement policies set by Medicare, the federal health insurance
program for the elderly.
In the WSJ article, Dr. Iyengar said about this issue: “I feel the
ivory tower mentality of a lot of major medical centers is to say, ‘We
would like this procedure done only in our hospital.' That doesn’t
serve the patient’s best interest.”
The two new clinical trials bolster the current debate swirling around
the standard of care for most patients with failing aortic valves, since
the data shows TAVR is just as effective in younger, healthier patients.
On average, the study subjects were in their low to mid-seventies, about
a decade younger than current patients.
Cardiovascular surgeons know that valves placed by open-heart surgery tend
to last 10 to 15 years. How long TAVR valves will last remains to be determined
as the patient data grows. The Centers for Medicare and Medicaid Services
is expected to propose new rules by the end of this month that would govern
which doctors and hospitals can offer TAVR.
Call our Structural Heart coordinator to schedule an assessment with Dr.
Hear how TAVR changed these BCH patients' lives
Read on for the full text of both articles:
Tens of Thousands of Heart Patients May Not Need Open-Heart Surgery
Replacement of the aortic valve with a minimally invasive procedure called
TAVR proved effective in younger, healthier patients.
by Gina Kolata,
The New York Times (March 16, 2019)
The operation is a daring one: To replace a failing heart valve, cardiologists
insert a replacement through a patient’s groin and thread it all
the way to the heart, maneuvering it into the site of the old valve.
The procedure, called transcatheter aortic valve replacement (TAVR), has
been reserved mostly for patients so old and sick they might not survive
open-heart surgery. Now, two large clinical trials show that TAVR is just
as useful in younger, healthier patients.
It might even be better, offering lower risks of disabling strokes and
death, compared to open-heart surgery. Cardiologists say it will likely
change the standard of care for most patients with failing aortic valves.
“Is it important? Heck, yes,” said Dr. Robert Lederman, who
directs the interventional cardiology research program at the National
Heart, Lung and Blood Institute. The findings “were remarkable,” he added.
Dr. Lederman was not involved with the studies and does not consult for
the two device companies that sponsored them.
In open-heart surgery, a patient’s ribs are cracked apart and the
heart is stopped to insert the new aortic valve.
With TAVR, the only incision is a small hole in the groin where the catheter
is inserted. Most patients are sedated, but awake through the procedure,
and recovery takes just days, not months, as is often the case following
the usual surgery.
The results “shift our thinking from asking who should get TAVR to
why should anyone get surgery,” said Dr. Howard Herrmann, director
of interventional cardiology at the University of Pennsylvania.
“If I were a patient, I would choose TAVR,” said Dr. Gilbert
Tang, a heart surgeon at the Icahn School of Medicine at Mount Sinai in
New York, who was not involved in the new research.
The studies are to be published in the New England Journal of Medicine
and presented on Sunday at the American College of Cardiology’s
The Food and Drug Administration is expected to approve the procedure for
lower-risk patients. As many as 20,000 patients a year would be eligible
for TAVR, in addition to the nearly 60,000 intermediate- and high-risk
patients who get the operation now.
“This is a clear win for TAVR,” said Dr. Michael J. Mack, a
heart surgeon at Baylor Scott and White The Heart Hospital-Plano, in Texas.
From now on, “we will be very selective” about who gets open-heart
surgery, said Dr. Mack, a principal investigator in one of the trials.
Some healthier patients will still need the traditional surgery —
for example, those born with two flaps to the aortic valve instead of
the usual three. Having two flaps can lead to early aortic valve failure.
TAVR was not tested in these patients, and the condition occurs more often
in younger patients who are low surgical risks.
Aortic valve failure stems from a stiffening of the valve controlling flow
from the large vessel in the heart that supplies blood to the rest of
the body. Patients often are tired and short of breath.
There is no way to prevent the condition, and no treatment other than replacing
the valve. The main risk factor is advancing age.
Although both studies enrolled over 1,000 patients, the trials differed
slightly in design, making direct comparisons difficult.
The study led by Dr. Mack and Dr. Martin Leon, an interventional cardiologist
at Columbia University in New York, tracked deaths, disabling strokes
and hospitalizations at one year following the procedures. The rates were
15 percent with surgery versus 8.5 percent with TAVR.
The rates of deaths and disabling strokes — the factors most important
to patients — were 2.9 percent with surgery versus 1 percent with TAVR.
The second study estimated deaths or disabling strokes at two years, finding
rates of 6.7 percent with surgery versus 5.3 percent with TAVR.
The trials were sponsored by makers of TAVR valves, Edwards Lifesciences
of Irvine, Calif., and Medtronic, headquartered in Dublin. The two companies
make slightly different valves.
The Edwards valve is compressed onto a balloon catheter that is pushed
through a blood vessel from the groin to the aorta. Once it reaches the
aorta, a cardiologist inflates the balloon and expands the valve, which
pushes aside the failing valve.
The Medtronic valve is made of nitinol, a metal that shrinks when it is
cold and expands when warm. The valve is chilled and put onto a catheter.
When it reaches the aorta, the cardiologist pulls back a sheath, freeing
the new valve. Warmed by the body, it expands to fill the narrowed opening
and remains there.
With traditional surgery, by contrast, a doctor cuts out the old valve
and sews in a new one, removing the old valve instead of leaving it in
Dr. Jeffrey J. Popma, an interventional cardiologist at Beth Israel Deaconess
in Boston, led the second trial and is a consultant for both manufacturers.
He uses both devices in surgery, and said the important finding is that
both [devices] were preferable to surgery.
The studies involved leading surgeons and cardiologists at academic medical
centers, many enlisted as consultants. Independent data and safety monitoring
committees oversaw the trials, and independent statisticians confirmed
Aortic valve replacements have been performed for decades, and surgeons
know the valves placed during surgery last at least 10 to 15 years. It
remains to be seen if TAVR valves will fare as well.
The question is especially important for younger patients. The average
age of subjects in the current studies was the low to mid 70s, younger
by a decade or more than most patients getting TAVR now.
Hospitals offering TAVR will take a financial hit when lower-risk patients
start opting for it, Dr. Herrmann said. The TAVR valves cost far more
than valves placed surgically, but insurers usually pay equally for either
“Open-heart surgery, particularly in low-risk patients, is very profitable,”
Dr. Herrmann said.
More than half a dozen companies make surgical valves, but only two market
TAVR valves. Perhaps with more competition, Dr. Herrmann said, prices
for TAVR valves will come down.
At the moment, it will be up to most patients which procedure they choose,
Dr. Popma said — TAVR or surgery.
For Robert Pettinato, 79-year-old retiree in Scranton, Pa., there was no
question. He had been feeling mild chest pain, and he was finding it difficult
to finish a round of golf.
But last year, when his cardiologist told Mr. Pettinato that he needed
a new valve, the only way he could get TAVR was to enter a clinical trial.
He enrolled in the Edwards trial at the University of Pennsylvania.
He had TAVR in November, stayed in the hospital for 24 hours and went home.
A few days later, he went to the football game at Lehigh University against
its archrival, Lafayette. (He’s a Lehigh alumnus and never misses
Shortly afterward, his younger brother Jim, who lives in Florida, had to
have aortic valve replacement. He wanted TAVR, but the clinical trials
were closed. He had surgery instead.
It took his brother four months to recover enough to play a round of golf,
Mr. Pettinato said.
Mr. Pettinato is back to playing golf himself. “I am the luckiest
guy in the world,” he said.
Smaller Hospitals Press for Chance to Offer Heart-Valve Procedure
Safety vs. accessibility is at center of debate as Medicare agency is poised
to propose new rules
by Peter Loftis,
Wall Street Journal (March 16, 2019)
A battle has broken out among doctors, hospitals
and medical-device makers over whether an increasingly
popular but risky medical procedure for replacing
defective heart valves should be offered more widely.
The fight is over which hospitals can get paid by the federal
government to perform the procedure, often
referred to as TAVR, for transcatheter aortic valve replacement.
Currently, bigger hospitals that perform the
procedures more frequently are favored under
federal reimbursement policies—based on
studies linking volume to quality—while smaller
hospitals have a tougher time meeting the rules to start or
maintain TAVR offerings.
TAVR has transformed treatment of certain heart-disease
patients by giving them an alternative to open-heart
surgery. Many of these patients are too sick to undergo the
risks of open-heart surgery; yet patients undergoing
TAVR also are at risk of complications, including stroke.
To ensure safety, TAVR’s use has been effectively
limited to bigger hospitals performing at
least 20 of the procedures annually. That is because
the federal Medicare health insurance program for
the elderly, the biggest payer of TAVR bills in the U.S., has
limited reimbursement to hospitals that
would perform higher volumes of the procedures.
The Centers for Medicare and Medicaid Services is expected
to propose new rules by the end of this month that would govern
which doctors and hospitals can offer it. Some doctors,
especially those in rural locations where it can be harder
to find a hospital performing TAVR, have argued
that advancements in the procedure have made it less risky.
The decision could affect revenue of the companies
that sell the replacement heart valves. Edwards Lifesciences,
the market leader, sold $2.2 billion in the valves world-wide
last year, while Medtronic PLC sold about $1.4 billion, according
to Jefferies LLC analyst Raj Denhoy.
Medicare’s move also could affect patients. Two new clinical
studies published online Saturday by the New
England Journal of Medicine suggest TAVR could
benefit a wider group of patients, including
those deemed healthy enough to withstand open-heart surgery. Researchers
are slated to present the results Sunday at the American
College of Cardiology’s annual meeting
in New Orleans.
One study, funded by Edwards, showed TAVR reduced rates of death,
stroke and re-hospitalization versus surgery. A Medtronic
study found TAVR was comparable to surgery in rates of
death and disabling stroke.
Yet a study published in JAMA Cardiology in 2017 found
there was a lower rate of readmission of patients 30 days
after TAVR procedures performed at high-volume
hospitals, 15.6%, than at lower-volume sites, where rates
were 19% to 19.5%. Patients were readmitted for heart complications
and infections, among other causes.
TAVR is for patients with a condition called aortic
stenosis, caused by a narrowing of the heart valve that
can lead to heart failure and death. The procedure consists
of threading a catheter through a patient’s artery and
then replacing the defective heart valve.
Nearly 200,000 patients in the U.S. have undergone TAVR
since it became available in 2011, including more
than 50,000 in the first nine months of last year, according
to the Society of Thoracic Surgeons, which manages
the registry of TAVR procedures. The procedures
can cost between $50,000 and $60,000 a patient, including
hospital admission costs.
Medicare’s reimbursement restriction limited
TAVR to about 600 hospitals in the U.S., a little more
than half the number that provide heart surgery. That has forced
patients in some rural areas to travel far to get the procedure,
and led their doctors and hospitals to lobby for expanded use.
Wyoming has no TAVR centers, forcing patients there to
drive several hours to hospitals in Colorado or elsewhere,
said Dr. Adrian Fluture, a cardiologist in Casper.
His practice sends about 30 patients a year out of state because
the Wyoming Medical Center in Casper doesn’t have the
volume of heart patients to meet the Medicare thresholds.
“Our concern is we’re not offering the right
treatment for the Wyoming population,” Dr. Fluture said.
Dr. Fluture and other doctors affiliated with
smaller hospitals say CMS should either eliminate
volume requirements or make them less restrictive.
They say TAVR has become a less complicated procedure
since it first came out, and there are existing tools to monitor
the safety of procedures, including a national registry
of the outcomes of TAVR procedures.
But doctors at larger hospitals and academic
medical centers say patient safety calls for restricting
TAVR to those who can do the procedure frequently.
“The more you do, the better you get at it,” said Dr.
Joseph Bavaria, professor of surgery at the University
of Pennsylvania’s Perelman School of Medicine
in Philadelphia, and co-author of the heart societies’
recommendations. “Some of these complicated
things shouldn’t be done at super-small hospitals.”
He says Penn’s hospital system performs between
400 and 500 TAVR procedures a year.
“I feel the ivory tower mentality of a lot of major
medical centers is to say, ‘We would like this procedure
done only in our hospital,’” said Dr. Srinivas
Iyengar, who helped start a TAVR program at Boulder Community
Health hospital in Boulder, Colo., in 2017. “That
doesn’t serve the patient’s best interest.”
The four major organizations representing
heart doctors, including the American College
of Cardiology, say there is a correlation
between volume and quality of TAVR procedures.
In a joint proposal to Medicare, the groups recommended
raising the volume requirements to hospitals
performing at least 50 a year or 100 over two years, up from
20 a year or 40 over two years.
Dr. Allen Baum, president of Cardiology Clinic
of San Antonio and supporter of the volume requirements,
said in a letter to CMS last year “there are some very powerful
lobbying forces that will want to liberalize these
criteria because of the financial benefit
to their institution. The device industry
wants to sell more devices, every small hospital CEO would
love to have this done at their hospital.”
Edwards Lifesciences, which initially was selective
about which hospitals and doctors could use its valves,
now favors dropping the volume requirements and allowing
lower-volume hospitals to offer the procedure,
saying it has become safer and more routine.
“We’re at a point in time where results have improved
dramatically,” Larry Wood, Edwards’ corporate
vice president of transcatheter heart valves, said in an
Medtronic favors maintaining current volume requirements
until better evidence emerges that they should be
adjusted. The company said in a letter to CMS last year
the evidence of a correlation between volume
and quality is mixed.
Call our Structural Heart coordinator to schedule an assessment with Dr.