Ouch.
This can't be good for local companies that make cardiac resynchronization devices -- meaning Medtronic, Boston Scientific and St. Jude Medical. A study published online Monday in the Archives of Internal Medicine indicates these expensive devices provide little benefit to almost 40 percent of patients suffering from heart failure. Here's the Wall Street Journal story.
This comes on the heels of a study published earlier this year in the Journal of the American Medical Association suggesting a sister device called implantable cardioverter defibrillators (ICDs) are overused. And the U.S. Department of Justice is investigating Medicare billing for the devices.
Update: Here are some key takeaways from a Medtronic statement on the recent CRT study (paraphrased):
1. Meta-analyses have limitations, and shouldn't be used for treatment guideline decisions.
2. Medtronic supports the use of treatment guidelines based on randomized clinical trials. There are a number of studies showing that patients who could benefit from certain implantable cardiac devices are not getting them. For example, a Medtronic study found only 41.2 percent of patients indicated for a CRT device received one.
3. Multiple randomized clinical trials demonstrate the significant benefit of CRT in the currently indicated patient population.
4. Noting that managing patients with heart failure is very complex, Medtronic said it is at the forefront of working to understand which patients benefit from CRT, having led multiple randomized clinical trials. When the European Society of Cardiology recently updated its guidelines for CRT therapy, 7 of the 11 clinical trials they used were Medtronic supported trials.
Janet Moore covers medical technology for the Star Tribune.
