Evidence Lacking for Inflatable-Pants Heart Failure Therapy
Heart Failure Treatment
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.
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The one controlled trial of external counterpulsation for heart failure is unpublished.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.