Costlier Heart Device May Not Be Worth It, Study Suggests

Dual-chamber implanted defibrillators had more complications than single-chamber models

By Brenda Goodman

HealthDay Reporter

TUESDAY, May 14 (HealthDay News) -- Patients prone to dangerously fast heart rhythms may get just as much help and have fewer complications with less-expensive implanted defibrillators that run one wire to the heart instead of two, a new study shows.

Implantable cardioverter defibrillators, or ICDs, are like having an emergency "crash cart" in the chest. The devices can sense runaway heart rhythms and deliver powerful shocks to jolt the heart back to a normal, steady pace.

Studies have shown that the devices cut deaths in patients at risk for sudden cardiac arrest because their heart muscles are too weak to effectively pump blood throughout the body, a condition called cardiomyopathy.

But little evidence exists to help doctors decide when it's better to choose a single-chambered ICD for patients or the more complex dual-chambered model.

The study, published in the May 15 issue of the Journal of the American Medical Association, compared the fates of more than 32,000 Medicare patients who received ICDs, from 2006 through 2009. None of the patients also needed a pacemaker, a device that speeds up a slow heartbeat.

"There is evidence for greater risk of complications. Not clear evidence of benefit. That risk-benefit ratio really doesn't support the routine use of dual-chamber devices for primary prevention," said study co-author Dr. Pamela Peterson, an associate professor of medicine at the University of Colorado at Denver.

About one-third of patients received a single-chamber ICD, in which an electrical lead is attached to the heart's lower right pumping chamber. The other two-thirds got dual-chamber devices, in which wires are attached to the upper and lower chambers of the heart's right side.

After a year, patients who got single-chamber ICDs were no more likely to die or be hospitalized than patients who got the more expensive dual-chamber models. They were, however, slightly less likely to face serious complications, including fluid build-up around the heart or lungs and mechanical problems with the device that required a second surgery to fix.

That was true even after researchers adjusted their results to control for any differences between patients who got single- and dual-chamber devices.

Overall, close to 4 percent of patients with single-chamber ICDs had complications with their devices compared to about 5 percent of patients with dual-chamber models, the investigators found.

The study was observational, which means researchers couldn't prove that the type of ICD was the only reason patients fared the way they did. Though they tried to carefully control their data for important differences between the two groups, other factors they couldn't measure, such as medications people were taking, may have influenced the results.

The study was funded by a grant from the U.S. Agency for Healthcare Research and Quality.

View the original article here

Standard Rheumatoid Arthritis Therapy as Good as Costlier Newcomer: Study

Biologic drug Enbrel wasn't better for patients who didn't respond to methotrexate alone

By Steven Reinberg

HealthDay Reporter

TUESDAY, June 11 (HealthDay News) -- Newer, costlier treatment for rheumatoid arthritis appears no better than an older, less-expensive regimen for people who don't respond to the first-line drug methotrexate, a new study suggests.

"Newer isn't always better," said researcher Dr. Ted Mikuls, an associate professor in the rheumatology division at the University of Nebraska Medical Center, in Omaha. "Some of the older medications can be effective."

Rheumatoid arthritis causes inflammation in the joints, resulting in swelling, stiffness, pain and reduced joint function. It can also affect other parts of the body.

"We compared two different ways of treating rheumatoid arthritis -- one that included a new biologic [medication] with an older, more conventional oral medication," Mikuls explained. "We basically showed that at the end of the day patients, regardless of what they got, looked very similar in terms of pretty much every outcome we looked at in the study."

Patients whose arthritis didn't respond to methotrexate alone who were then given a combination of methotrexate, sulfasalazine (Azulfidine) and hydroxychloroquine (Plaquenil) did as well as patients given methotrexate and the new biologic drug etanercept (Enbrel) -- which is given by injection -- the researchers said.

"The treatments are very different in terms of costs," Mikuls said. If a patient had to pay out of pocket for etanercept it could cost around $20,000 a year, while the out-of-pocket costs for the other drugs is a few hundred to a few thousand dollars, he said.

The out-of-pocket cost of etanercept varies by insurance provider, including those covering the Medicare drug benefit program, Mikuls added.

The report was published online June 11 in the New England Journal of Medicine to coincide with presentation of the study at the Annual European Congress of Rheumatology meeting in Madrid, Spain.

"This study addresses a real-life scenario for rheumatologists where patients are often on methotrexate and are not doing well and the question is what to do next," said Dr. Soumya Reddy, an assistant professor in the rheumatology division of the dermatology department at NYU Langone Medical Center, in New York City.

About 20 percent to 40 percent of patients don't respond methotrexate or can't take the drug either because of side effects or it is not indicated for them, said Reddy, who was not involved in the study.

The findings are "reassuring," in that when a biologic is not an option, due to cost or other reasons, the older regimen is effective, she said.

Which regimen is best really needs to be tailored to each patient, Reddy said.

For the study, researchers randomly assigned 353 patients to methotrexate, sulfasalazine and hydroxychloroquine or to methotrexate and etanercept for 48 weeks. Some patients switched from one regimen to another midway through the study.

View the original article here

Costlier Heart Device May Not Be Worth It, Study Suggests

Dual-chamber implanted defibrillators had more complications than single-chamber models

By Brenda Goodman

HealthDay Reporter

TUESDAY, May 14 (HealthDay News) -- Patients prone to dangerously fast heart rhythms may get just as much help and have fewer complications with less-expensive implanted defibrillators that run one wire to the heart instead of two, a new study shows.

Implantable cardioverter defibrillators, or ICDs, are like having an emergency "crash cart" in the chest. The devices can sense runaway heart rhythms and deliver powerful shocks to jolt the heart back to a normal, steady pace.

Studies have shown that the devices cut deaths in patients at risk for sudden cardiac arrest because their heart muscles are too weak to effectively pump blood throughout the body, a condition called cardiomyopathy.

But little evidence exists to help doctors decide when it's better to choose a single-chambered ICD for patients or the more complex dual-chambered model.

The study, published in the May 15 issue of the Journal of the American Medical Association, compared the fates of more than 32,000 Medicare patients who received ICDs, from 2006 through 2009. None of the patients also needed a pacemaker, a device that speeds up a slow heartbeat.

"There is evidence for greater risk of complications. Not clear evidence of benefit. That risk-benefit ratio really doesn't support the routine use of dual-chamber devices for primary prevention," said study co-author Dr. Pamela Peterson, an associate professor of medicine at the University of Colorado at Denver.

About one-third of patients received a single-chamber ICD, in which an electrical lead is attached to the heart's lower right pumping chamber. The other two-thirds got dual-chamber devices, in which wires are attached to the upper and lower chambers of the heart's right side.

After a year, patients who got single-chamber ICDs were no more likely to die or be hospitalized than patients who got the more expensive dual-chamber models. They were, however, slightly less likely to face serious complications, including fluid build-up around the heart or lungs and mechanical problems with the device that required a second surgery to fix.

That was true even after researchers adjusted their results to control for any differences between patients who got single- and dual-chamber devices.

Overall, close to 4 percent of patients with single-chamber ICDs had complications with their devices compared to about 5 percent of patients with dual-chamber models, the investigators found.

The study was observational, which means researchers couldn't prove that the type of ICD was the only reason patients fared the way they did. Though they tried to carefully control their data for important differences between the two groups, other factors they couldn't measure, such as medications people were taking, may have influenced the results.

The study was funded by a grant from the U.S. Agency for Healthcare Research and Quality.

View the original article here