MASSDEVICE ON CALL — More researchers are finding evidence of misused heart therapies that may be costing thousands of lives each year, making the case that both underuse and overuse of implanted cardioverter defibrillators and cardiac resynchronization therapies are a problem in the health care industry.
Earlier this year researchers found that more than one in five patients implanted with ICDs may not have needed the device. The study, published in the Journal of the American Medical Assn., kicked up a firestorm of attention and skepticism.
Medical device giants like Boston Scientific Corp. (NYSE:BSX) said the study’s data was taken out of context and Medtronic Inc. (NYSE:MDT) said the study hurt their ICD sales.
But news research shows that more than 12,000 lives may be saved each year if more patients are implanted with ICDs. The study, published in the American Heart Journal, also found that another 8,000 might be saved by more CRTs, MedCity News reported.
The AHJ researchers insist their study isn’t a rebuttal to the JAMA article, but further evidence that implantable heart device guidelines aren’t properly followed.
Adding fuel to the fire, researchers from Ohio’s University Hospitals and Case Medical Center argue that the guidelines themselves are too broad, finding that 40 percent of patients implanted with CRT devices aren’t benefited by them anyway, Heartwire reported.
Reduced anticoagulants recommended for HeartMate II patients
Patients implanted with Thoratec Corp.’s (NSDQ:THOR) continuous-flow HeartMate II left ventricular assist device may be getting too much anticoagulant therapy, according to a new study presented at the American Society of Artificial Internal Organs annual conference.
"There are [enough] data now accumulating on the HeartMate II that it is relatively safe to lower the anticoagulation targets. The thrombosis rate is very low, so we may be over anticoagulating these patients, which is causing the higher incidence of GI bleeding and hemorrhagic stroke," presenter Dr. Jeffrey Morgan of the Henry Ford Hospital in Detroit told Heartwire.
The HeartMate II device won FDA clearance as a “destination therapy” in January 2010.
Weight-loss surgery doesn’t improve survival
Older, severely obese patients get no improved survival benefit from bariatric weight-loss surgery as compared to conventional care, according to a JAMA study.
Doctors "should counsel their patients that there are numerous significant benefits to bariatric surgery—including the fact that it’s the most effective weight-loss treatment, and it improves the control of chronic conditions and quality of life—but there doesn’t appear to be a survival benefit at nearly seven years,” presenter Dr. Matthew Maciejewski of Durham VA Medical Centers told Heartwire.
Car-maker owes success to medical devices
Delphi Automotive Systems got a new lease on life, largely thanks to a brief foray into the world of medical device manufacturing, Xconomy reported.
The Troy, Mich.-based auto part maker hired an executive from Baxter International Inc. (NYSE:BAX) in 2003, and began eyeing the medical device market.
The endeavor was short-lived, but Delphi Medical Systems managed to generate more than $100 million in revenue in just three years. The company opted to sell off the medical device segment when it filed for bankruptcy in 2009, but short-lived department head Christophe Sevrain said it "changed the status quo. The company was now more willing to change and adapt."
NIH names new head for National Institute of General Medical Sciences
Judith Greenberg has been tapped as the new acting director for the National Institutes of Health’s National Institute of General Medical Sciences, effective next month, replacing departing director Jeremy Berg.
Greenberg, who was also interim director of NIGMS from May 2002 to November 2003, will oversee the institute’s $2 billion budget while NIH continues to search for a permanent director.
