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Senior Alert
'Inflatable-Pants' Heart Failure Therapy Lacks
Supporting Evidence
By
Taunya English, Science Writer
Health Behavior News Service
 Feb.
21, 2006 - A new review of studies supports the government’s opinion
that too little evidence exists to support a device that uses
balloon-like pants as a treatment for heart failure. External
counterpulsation (ECP), a noninvasive therapy to improve blood flow to
the heart, is most commonly used to relieve hard-to-treat chest pain for
heart patients who are not candidates for surgery.
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Last year, the equipment manufacturer asked the
federal government to expand its coverage of ECP and begin reimbursing
cardiologists who use the device for other heart conditions, including
heart failure.
The Centers for Medicare and Medicaid Services —
which sets reimbursement guidelines for the two federal benefit programs
— declined to expand its policy on external counterpulsation to cover
heart failure or other cardiac conditions. Now, the Technology
Evaluation Center of the Blue Cross and Blue Shield Association, whose
member companies represent the largest health benefits provider in the
United States, has reviewed the science behind ECP for heart failure.
“The evidence supporting the role of ECP as an
effective treatment for heart failure is lacking in both quantity and
quality,” the review found.
The one controlled trial of external
counterpulsation for heart failure is unpublished. It showed some modest
improvements in the time patients were able to exercise and some gains
in patients’ ranking on a scale that classifies the extent of heart
failure, the review said.
“To me it’s not convincing evidence,” said senior
scientist David Mark, M.D., of Blue Cross and Blue Shield Association’s
Technology Evaluation Center.
The systematic review was conducted by the
Technology Evaluation Center (TEC), which analyzes clinical and
scientific evidence to evaluate whether a technology improves health
outcomes. This is the first time TEC evaluated the device as therapy for
heart failure, and ECP did not measure up.
TEC Assessments provide objective information to
those who deliver and manage medical care. They are based on clinical
and scientific evidence and evaluate whether a technology improves
health outcomes, such as length of life, quality of life and ability to
function. TEC Assessments are not recommendations for health care by
providers or for coverage decision by health insurance companies.
Vasomedical Inc., which makes ECP technology,
disagrees with the Blue Cross and Blue Shield Association opinion. In a
written response, the company said external counterpulsation is a “safe,
noninvasive, low-cost” therapy that could benefit many more patients.
“We are not sure where the Blue Cross and Blue
Shield technology assessment group sets the threshold for clinical
evidence of efficacy, but we feel strongly that we have met any
reasonable standard,” the statement said.
In ECP, patients wear a set of balloon-like pants
programmed to inflate in sequence with the heart beat. Pneumatic cuffs
fit snugly around the legs and thighs and are designed to force
oxygen-rich blood to the top half of the body to fuel the heart. “The
theory is that it allows the heart to rest and renew itself,” said Brent
O'Connell, M.D., a member of the Association's Medical Advisory Panel,
which oversaw the TEC research review.
The new review also revisits Blue Cross and Blue
Shield Association’s past evaluation of ECP for chest pain, or angina.
While most Blue Cross and Blue Shield companies do not cover ECP therapy
for chest pain, Medicare and some other health insurers do.
Mark said that, given the measures used, rigorous
studies on ECP showed a lack of consistent improvement, leaving doubts
about whether even the positive findings were clinically or functionally
meaningful. There is one published, randomized, controlled trial of ECP
for chest pain.
Cardiologist Frederick Masoudi, with the Denver
Health Medical Center, who was not involved with the new review, said
while noninvasive therapies for cardiac conditions are welcome, ECP is
not widely prescribed for chest pain, and is rarer as a heart failure
therapy.
Masoudi said ECP is not used at any of the
facilities where he works, and he has not seen patient demand for the
therapy. ECP is typically administered outside of the hospital, often at
freestanding care sites dedicated to the therapy.
“When this first came out, there were some major
institutions who invested lots of money putting in the equipment,”
O’Connell said. “There’s always going to be early adopters for new
technology. Most of medicine wanted to wait for the long term studies.”
The 38 Blue Cross and Blue Shield health plans make
independent decisions about medical coverage, and currently several
plans do pay for ECP therapy. But O’Connell, who is also vice-president
and medical director, Pennsylvania Blue Shield/Highmark, predicts that
the TEC review will prompt some insurers to scale back coverage or
change their policies in coming months.
“This is a no-brainer for those in the
reimbursement field,” he said.
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