US Research Demonstrates that Defibrillators Live Up to Clinical Trials

Published date : 09 January 2013
Article date : 09 January 2013


Futurity hosts an article on a study published in the Journal of the American Medical Association which used data from a large national Medicare registry to assess the survival of patients receiving defibrillators which are used to prevent sudden cardiac death.

It says that because clinical trial participants tend to receive more meticulous care while also being healthier than patients seen in clinical practice, the actual benefits of new drugs and medical devices can be less positive than initially reported. Not so, they say, for the defibrillators, at least when comparing patients with similar characteristics in both the clinical trials and real-world practice.

Lead author Sana M. Al-Khatib, an electrophysiologist and member of the Duke University Clinical Research Institutev said, “We showed that patients in real-world practice who receive a defibrillator but who are most likely not monitored at the same level provided in clinical trials have similar survival outcomes compared to patients who received a defibrillator in the clinical trials.”

Implantable cardioverter-defibrillators (ICDs) have been lifesavers for people with a history of cardiac arrest or heart failure. The small electrical devices are implanted in the chest with wires that lead into the heart, sending an electronic pulse when the heart stops beating to reestablish a normal rhythm.

To monitor treatment patterns, effectiveness and safety of ICDs among Medicare patients in the US, the Centers for Medicare & Medicaid Services mandated that data on all Medicare patients receiving a primary prevention ICD be entered into a national registry. 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. By comparing similar populations, researchers were able to address the concern that outcomes reported in clinical trials are overly optimistic.

Source: Duke University (hosted on, 07 January 2013.

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