Subcutaneous ICD therapy results in a similar quality of life compared with transvenous ICD therapy during both short- and long-term follow-up

Abstract Funding Acknowledgements Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Boston Scientific Medical device company St. Paul, Minnesota, USA Introduction 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. It is unknown whether there is a difference in quality of life (QoL) between the two patient groups. The generator size and implant location differ between both devices. This may cause a variation in mental health status and pain perception between treatment arms, in particular in older patients, patients with low BMI, and females. Purpose This prespecified analysis of the PRAETORIAN trial compares the impact of the S-ICD and TV-ICD on QoL. Methods In the PRAETORIAN trial, 849 patients were randomised 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. Subgroups were made based on age (tertiles, < 58, 58-67 and >67 years), BMI categories (<25, 25-30, and ≥30 kg/m2) and sex. In these subgroups, we only looked at differences in pain and mental health between arms. Treatment effects, 95% CIs and interactions were calculated by regression models. Results A total of 823/849 patients completed the QoL questionnaires at baseline. Questionnaires were also completed by 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 (p>0.05, figure). Age, BMI and sex were not associated with a difference between the arms in SF-36 subscale bodily pain (p=0.73, 0.72 and 0.92 respectively), or SF-36 subscale mental health (p=0.15, 0.39 and 0.76) at 30 months. Similar results were seen at discharge and 12 months. Conclusion There were no differences in QoL between S-ICD and TV-ICD treatment in the first 30 months after implant. In addition, no differences in pain and mental health were seen in older patients, patients with low BMI and females. These results confirm that the S-ICD is a good alternative for the TV-ICD.