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Real-world patient survival with defibrillators matches trial expectations
Date:1/1/2013

g to reestablish a normal rhythm.

To monitor treatment patterns, effectiveness and safety of ICDs among Medicare patients, the Centers for Medicare & Medicaid Services mandated that data on all Medicare patients receiving a primary prevention ICD be entered into a national registry. In response to this mandate, a national ICD Registry has been collecting data from hospitals performing implantations since 2005. The Duke-led research group used data from that registry to compare more than 5,300 real-world patients against more than 1,500 patients who had enrolled in two large clinical trials of ICD devices.

Al-Khatib said the patients who were included in the analysis were selected to closely resemble the patients who participated in the clinical trials, with much older and sicker patients in the registry excluded. Both groups study participants who received an ICD and ordinary recipients - had similar two-year and three-year survival rates. Ordinary recipients had better survival than patients in the clinical trial who did not receive an ICD. These findings were true for Medicare and non-Medicare patients.

By comparing similar populations, the researchers were able to address the concern that outcomes reported in clinical trials are overly optimistic because patients receive extraordinary care.

"We know from previous studies that many patients in real-world clinical settings don't receive the follow-up care that is recommended after the device is implanted," Al-Khatib said. She said doctors who participate in clinical trials also tend to be highly skilled specialists who do hundreds of the implantation surgeries, while physicians in ordinary practice may be less proficient. Studies have shown that patients have more complications when their doctors have less experience with a procedure.

Al-Khatib said the study had a limitation that could warrant additional examination. By eliminating Medicare patients who were apprecia
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Contact: Rachel Harrison
rachel.harrison@duke.edu
919-419-5069
Duke University Medical Center
Source:Eurekalert

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