Federal health officials are due to publicly release records of tens of thousands of recent heart-defibrillator implants, which will include data showing that less than 5 percent of the patients experienced complications during the implant procedure. However, the Centers for Medicare and Medicaid Services will not release any information identifying doctors involved in the procedures, according to the New York Times.
Here are some excerpts:
The agency released the data Friday to The New York Times in response to a Freedom of Information Act request filed last year. It said it planned to release the data on its Web site today.
The complication rate in the Medicare records falls within the general boundaries of studies that have looked at the matter. But such studies have also indicated that complication rates can vary widely among doctors and hospitals based on factors like the number of implants a doctor performs.
The agency’s decision not to publish data on doctors could reignite a long-running debate over patient access to data that shows how complication rates for widely used procedures like heart device implants differ among doctors and hospitals. For example, studies have indicated that for defibrillator implants, such rates can vary sharply based on factors like the number of procedures a doctor performs.
An implantable defibrillator is a device that interrupts a potentially fatal type of heart rhythm.
An analysis of the data by The Times indicates that about 4 percent of the 45,000 patients who underwent implants reported at least one complication to the agency over a 16-month period ended in April. The two most frequently reported ones – blood clots and displacement of a cable that connects a device to the heart – can vary in their degree of severity.
Dr. McClellan added that the agency would soon make all the defibrillator data, including information on doctors, available to researchers, who typically agree to keep the names of the doctors and hospitals confidential. The new records are the first batch of hundreds of thousands of similar ones that the agency plans to collect to see which types of heart patients benefit from a defibrillator.
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