Home' The Source : Fourth Quarter 2011 Contents [ SourceBook ]
UNDER THE MICROSCOPE
Edwards Lifesciences expects
to train between 150 and 250
TAVR programs in the first year
of commercialization, based on
the firm's assessment of inter-
ested centers' capabilities and
current volume of aortic valve
HealthTrust is working with members
and vendors to help them understand the
new technology and what's involved in ac-
quiring it. That includes patient selection,
equipment and facility needs, and where
the hospital teams can get training.
There appears to be a significant market
for a less-invasive treatment.
It is estimated that up to 1.5 million peo-
ple in the United States su er from aortic
stenosis. Approximately 300,000 of these are severely stenotic cases
that can develop debilitating symptoms restricting normal daily
activity. Available valve replacement therapy is applicable to only
about two-thirds of these patients. The remainder are not referred
for it as they are too high-risk for surgery.
Patients do not undergo surgical valve replacement are without
e ective, long-term treatment options to prevent or delay the pro-
gression of the disease. Unfortunately, without treatment, severe,
symptomatic aortic stenosis can be life-threatening.
Transcatheter replacement eliminates the need for open-heart
surgery and its associated long recovery period. Guided by X-ray
imaging, the team inserts the catheter into the femoral artery and
up to the top of the heart where the aortic valve is located.
Once it has reached the damaged valve, they inflate a balloon to
open the metal frame that holds the three-leafed replacement valve.
It compresses the old valve's leaves against the aorta and the frame
holds the new valve in place. They withdraw the catheter and close
the wound in the groin.
Clinical studies so far have focused on treating the sickest patients.
Many people put o treatment until their condition is too advanced
for traditional surgery, Tarkington notes. Medications used to treat
symptoms have side e ects and can interact with other drugs.
"It's hard to regulate the dosage of all those medications, and the
patients often have repeated hospital stays because of interactions
or as the disease worsens. TAVR may change that and extend their
lives," she says.
As with other kinds of transformative techniques, TAVR will
likely be available first in regional centers of excellence for heart
valve disease. There will be strict patient selection criteria, exten-
sive documentation and careful follow-up to develop best-practice
protocols of care and track outcomes.
Those centers will also develop training and credentialing
criteria for practitioners. And the patient outcomes will be followed
closely to determine if the process should be made available to other
Better Outcomes, Potentially Less Cost
Cost-e ectiveness analysis of TAVR patients compared with
patients receiving only medication showed the former had fewer
hospitalizations during the year after initial treatment.
Though the upfront cost of TAVR was higher, on average those
patients incurred $25,000 less in hospital costs over a year than
drug therapy patients. Similar studies are under way comparing
TAVR with open-heart patients.
Besides access issues, cost and reimbursement issues also remain
unsettled, Tarkington says.
Traditional valve surgery can be profitable for hospitals, but for
the index admission, TAVR will likely not be profitable. However,
hospitals participating in the clinical trials on TAVR anecdotally
reported a 20 percent increase in traditional valve surgery volume
as word spread. "That means they had non-traditional patients ask-
ing about it and being screened more appropriately for open-heart
valve surgery," Tarkington says.
FDA approval for TAVR will enable medical researchers to
refine techniques and procedures, and build a body of data that will
determine whether to expand the potential patient pool to younger
and healthier patients, she says.
There is a great deal of activity in the vendor community in the
area of transcatheter valve technology. Multiple clinical trials are
ongoing or being planned worldwide to study a variety of tech-
nologies. It will be important for health-care providers to keep up
to date on the future of transcatheter valves and structural heart
therapies. The SourceTrust team of clinical experts is available to
assist HealthTrust members in this area. •
VALVE DISEASE AFFECTS 2.5 PERCENT OF THE U.S. POPULATION,
according to the American Heart Association. Approximately 13
percent of patients over age 75 have valve disease. The most com-
mon kind of valve disease is aortic stenosis, a progressive disease
that accounts for 43 percent of all heart valve cases.
The aortic valve works harder than any of the other heart
valves because it controls blood flow out of the heart. It
operates under tremendous pressure, which can cause it
to wear out.
Aortic stenosis is the narrowing or obstruction of the aortic
heart valve and is most often caused by accumulations of calcium deposits on the valve's
leaflets. The resulting stenosis impairs the valve's ability to open and close properly.
Genes and lifestyle also play a role in the likelihood of developing valve disease. Typical
symptoms include shortness of breath and weakness.
What is Valve Disease?
COURTESY EDWARDS LIFESCIENCES
The leaflets of a stenotic
or calcified aortic heart
valve are unable to open
wide, obstructing blood
flow from the left ventricle
into the aorta.
22 Fourth Quarter 2011 | The Source
Links Archive First Quarter 2012 Third Quarter 2011 Navigation Previous Page Next Page