On September 27, 2010, the peer-reviewed scientific journal Europace published online-before-print a case report entitled “Spontaneous explosion of implantable cardioverter-defibrillator” by Martin Hudec and Gabriela Kaliska. In the pdf of that case report a figure containing a color photo of the affected patient’s chest, chest X-ray, and two pictures of the extracted device (one seen here) were included.
The pictures and case presentation were dramatic and the case very rare. Both were perfect reasons to report such an important case to the medical literature. And so these doctors sent the case to Europace on June 29, 2010, and the article was accepted after revision on August 16, 2010, with the article appearing online September 27, 2010.
The authors must have felt very proud to have an article published relatively quickly, and the editors and reviewers of Europace must have thought the case was unique enough and important enough to have the article revised according to their specifications, then published online — until I reported the case on this blog on October 5, 2010, and included images from a portion of the case report’s figure.
Remarkably, later that same day, Europace removed the case report from its website without comment. The article simply vanished. I attempted to e-mail the editor of Europace to inquire about the reason for the retraction but received no reply, so I contacted the lead author, Martin Hudec, M.D. He kindly responded and I included his email response in the comments to my post two days later. Read more »
*This blog post was originally published at Dr. Wes*
A paper published in the February issue of Health Affairs – discussed at length in an article in the New York Times – contains the sort of blunt, plain-spoken language you seldom read in academic journals. The authors, who include some of the most prominent neuroscientists and ethicists in the world, warn that manufacturers are misusing the FDA’s humanitarian device exemption to promote deep brain stimulation as a “treatment” for obsessive compulsive disorder (OCD).
In fact, they make clear that deep brain stimulation is very much an experimental procedure. Research is still at an early stage, and the risks to patients are not well defined. When suffering is severe and no other treatment has provided relief, there is value in making available an intervention like deep brain stimulation. But misleading or biased information, no matter where it comes from, certainly undermines patients’ ability to calculate benefits and risks.
To enable deep brain stimulation, a surgeon must first implant electrodes in the brain and connect them to a pair of small electrical generators underneath the collarbone. Deep brain stimulation uses electricity to affect how brain signals are transmitted in particular areas of the brain. The image to the left, from the National Institute of Mental Health, shows how deep brain stimulation depends on the implantation of pulse generators below the collarbone and electrodes in the brain.
Specific concerns are raised by the article in Health Affairs (and in our own article on this topic last year in the Harvard Mental Health Letter). Read more »
*This blog post was originally published at Harvard Health Blog*
This was the Guest Blog at Scientific American on February 16th, 2011.
New wave of MRI-safe pacemakers set to ship to hospitals
This week Medtronic will begin shipping to hospitals in the United States the first pacemaker approved by the FDA as safe for most MRI scans. For consumers, it is a significant step in what is expected to be a wave of new MRI-compatible implanted cardiac devices.
But this is an example of one technology chasing another and the one being chased, the MRI scanner, is changing and is a step ahead of the new line of pacemakers. The pacemaker approved for U.S. distribution is Medtronic’s first-generation pacemaker with certain limitations, while its second-generation MRI-compatible pacemaker is already in use in Europe where approval for medical devices is not as demanding as it is in the U.S. So let’s check out what this is all about — what it means now for current and future heart patients and where it may be headed.
We are all born with a natural pacemaker that directs our heart to beat 60 to 100 times a minute at rest. The pacemaker is a little mass of muscle fibers the size and shape of an almond known medically as the sinoatrial node located in the right atrium, one of four chambers of the heart. The natural pacemaker can last a lifetime. Or it can become defective. And even if it keeps working normally, some point may not function well along the electrical pathway from the pacemaker to the heart’s ventricles which contract to force blood out to the body.
Millions of people in the world whose hearts beat too fast, too slow, or out of sync because their own pacemaker is not able to do the job right, follow their doctors’ recommendation to get an artificial pacemaker connected to their heart to direct its beating. The battery-run pacemaker in a titanium or titanium alloy case the size of a small cell phone, (why can’t it be the size of an almond?) is implanted in the upper left chest, just under the skin, with one or two insulated wire leads connecting to the heart. It can be programmed to run 24/7 or to only operate when the heart reaches a certain state of irregular beating. Read more »
*This blog post was originally published at HeartSense*
Electroconvulsive therapy (ECT) is considered to be a highly effective treatment for depression. The story goes that roughly 90 percent of patients respond. The downside is that it requires general anesthesia with all its attendant risks, and patients may suffer from headaches and memory loss. The memory loss is often mild, but there are cases where it is profound and very troubling.
As with any psychiatric treatment — or so it seems — there are those who say it saved them and those who say it destroyed them. Because the risks aren’t minor, the procedure is expensive and often done on an inpatient unit, and people generally don’t like the idea of having an IV line placed, being put under, then shocked through their brain until they seize, only to wake up groggy and perhaps disoriented with an aching head, it’s often considered to be the treatment of last resort, when all else has failed. This makes the 90 percent response rate even more powerful.
I’m no expert on ECT. I haven’t administered it since I was a resident and I don’t work with inpatients where I see people before and after. I’ve rarely recommended it, and then I’ve been met with a resounding, “NO.” My memory of it was that it worked, and that most people didn’t complain of problems. One woman read a novel during her inpatient stay. I asked if she had trouble following the plot (ECT in the morning, novel reading in the afternoon), and she said no.
The Food and Drug Administration (FDA) has been looking at the safety and efficacy of the machines used to perform ECT. It’s a fairly complex story where the FDA advisory panel was considering whether to keep ECT machines categorized as “Class III” machines, which would now require machine manufacturers to prove their efficacy and safety. A reclassification as Class II (and therefore lower risk) would not require this stringent proof. Read more »
*This blog post was originally published at Shrink Rap*
Remember that cold December in 1999 when we all thought that planes would soon be dropping out of the sky, nuclear power plants were to be melting down, and the world was going to end? This weekend Health Canada is giving clinicians across the country (and really all of North America) an opportunity to feel the anxiety, fear, and excitement all over again.
In 2007, the dates for switching between Standard and Daylight Saving time were changed, and the authorities, three years into the new schedule, have issued a warning for this weekend’s one hour rollback:
Medical equipment manufactured prior to 2007 may not function optimally if the equipment has not been updated by manufacturers to compensate for the new dates.
To date, Health Canada has not received any reports of device malfunctions because of the revised time change that began in 2007. However, examples of medical devices that could be affected by the change include (but are not limited to): implanted pacemakers/defibrillators with sleep modes that can only be adjusted by physicians; Holter monitors, used to continuously record heartbeat; and glucose monitors that store data on glucose levels.
If a medical device displays the incorrect time after 2:00 a.m. on Sunday, November 7, 2010, users should contact the manufacturer to bring the problem to their attention and consult a health care professional.
Press release: Health Canada Reminds Canadians to Check Medical Device Clocks After the Switch to Standard Time …
Image credit: Dan Woods…
*This blog post was originally published at Medgadget*