Controlled Clinical Trial
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Posttraumatic stress and quality of life with the totally subcutaneous compared to conventional cardioverter-defibrillator systems.

BACKGROUND: For prevention of sudden cardiac death, the transvenously implantable cardioverter-defibrillator therapy (tv-ICD) is well accepted. The subcutaneous system (S-ICD® ) is promising in terms of reducing ICD complications. Nevertheless, the impact of the novel generator position on patients' quality of life (QoL) is yet unknown.

OBJECTIVE: This study aimed at comparing QoL and posttraumatic stress with both systems.

METHODS: 60 S-ICD® and 60 case-controlled tv single-chamber ICD patients were asked to respond to three standardized questionnaires. PDS [screening for posttraumatic stress disorders (PTSD)] and PHQ-D (detection of the most predominant psychological disorders) were used to screen for potential mental comorbidities. The SF-12 questionnaire was used to evaluate physical and mental well-being. Groups were compared in terms of QoL and PTSD.

RESULTS: n = 42 (70%) pairs were analyzed (n = 30 male, mean age 44.6 ± 12.2 years). Prior appropriate (p = 0.06) or inappropriate episodes (p = 0.24), ejection fraction (p = 0.28), or underlying cardiac disease did not differ significantly between groups. PDS revealed a PTSD in n = 6 tv-ICD and n = 6 S-ICD® patients (14.3%) equally. In the PHQ-D questionnaire, n = 4 tv-ICD and n = 2 S-ICD® patients fulfilled criteria for a major depression (p = 0.68). Panic disorders (n = 2 tv, n = 0 S-ICD® , p = 0.5), and anxiety disorders (n = 3 S-ICD® , n = 0 tv-ICD, p = 0.24) did not differ between groups. The physical well-being score was 39.9 ± 12.5 in patients with a tv-ICD compared to 46.6 ± 9.9 in S-ICD® patients (p = 0.01). The mental well-being score was comparable in both groups (tv-ICD 51.8 ± 10.8 vs. S-ICD® 51.9 ± 10.4, p = 0.95).

CONCLUSIONS: Our case-control study revealed equal or even better physical well-being of patients with the S-ICD® . PTSD occurred in almost 15% of ICD patients irrespective of the type of system.

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