Mp-453086-5 quality of life after shocks or complications is similar between subcutaneous and transvenous defibrillator therapy

The PRAETORIAN trial showed that the subcutaneous implantable cardioverter defibrillator (S-ICD) is noninferior to the transvenous ICD (TV-ICD) with respect to device-related complications and inappropriate shocks in a conventional ICD population. Nevertheless, the type of complications and underlying mechanism for inappropriate shocks differ between devices. Earlier studies have reported a decrease in quality of life (QoL) in ICD patients with shocks or complications. It is unknown if there is a difference in QoL between the devices in general, and whether shocks and complications are associated with the same burden in both arms. This prespecified analysis of the PRAETORIAN trial compares the impact of the S-ICD and TV-ICD on QoL and investigates if shocks and complications cause a device-specific reduction in QoL. In the PRAETORIAN trial, 849 patients were randomized to S-ICD (n=426) or TV-ICD (n=423) therapy. QoL was prospectively measured at baseline, discharge and 12 and 30 months after ICD implant, by measuring cardiac-specific physical functioning with the Duke Activity Status Index (DASI) and psychological and physical well-being with the 36-Item Short Form Health Survey (SF-36, divided in 8 subscales). Patients who completed the questionnaires at baseline were included in this analysis. At each time point the mean change in score from baseline was calculated. Patients with and without a shock or device related complication requiring intervention before their 12 month QoL were compared. Regression models and Wilcoxon rank sum tests were used to compare groups. A total of 823/849 patients completed the questionnaires at baseline. Questionnaires were also completed by the majority of these patients at discharge (92%), 12 months (85%) and 30 months (69%). There was no difference in QoL between the arms at any time point (figure). At 12 months, patients with a shock or complication showed a significantly lower QoL on the DASI (p=0.005) and SF-36 subscales bodily pain (p=0.04), vitality (p=0.006) and role specific functioning – emotional (p=0.03). This was not significantly different between the arms. There were no differences in QoL between S-ICD and TV-ICD treatment in the first 30 months after implant. Patients with ICD shocks or complications requiring intervention showed a reduction in QoL at 12 months, but this did not differ between arms. These results confirm that the S-ICD is an acceptable alternative for the TV-ICD.