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The PRAETORIAN DFT study shows in patients where the PRAETORIAN score was calculated instead of the DFT, the S-ICD also functioned properly.
Background
When patients have an increased risk of sudden cardiac death due to a cardiac arrhythmia, they receive an Implantable Cardioverter Defibrillator (ICD). A subcutaneous ICD, also known as an S-ICD, is a type of ICD in which the electrode (the lead) is placed just under the skin instead of directly in the heart. During or shortly after the implantation of the S-ICD, a defibrillation test (DFT) is performed. During this procedure, the patient is placed under general anesthesia and a life-threatening cardiac arrhythmia is induced. This allows the doctor to test whether the S-ICD can successfully stop the arrhythmia with an electric shock. Although effective, such a test entails additional risks
Study design
Researchers from Amsterdam UMC therefore devised an alternative: the PRAETORIAN score. This is a points system that checks the position of the S-ICD and the lead based on standard post-operative X-rays. If everything is positioned optimal (a score below 90), the expectation is that the S-ICD will properly detect and terminate the arrhythmia in almost all cases. The PRAETORIAN DFT trial was set up to investigate whether this score can indeed replace the DFT. For this purpose, 965 patients were randomly divided into two study groups. Half (482 patients) received the DFT, while for the other half (483 patients), the PRAETORIAN score was applied to the X-rays. The patients were followed intensively for 40 months (almost 3.5 years). In total, 37 hospitals in Europe, the United States, and the Middle East participated in this study.
Main study results
The PRAETORIAN DFT trial has shown that in patients where the PRAETORIAN score was calculated instead of performing the test, the S-ICD also worked well. When patients experienced a life-threatening arrhythmia in daily life, the first shock of the S-ICD was just as effective as in patients who did undergo a defibrillation test. In addition, patients where the DFT was ommitted, experienced fewer complications related to the implantation procedure. There was no difference in survival rates between the group with and without DFT.