P3876Health-related quality of life impact of a transcatheter pacing system

Abstract

Background: Transcatheter pacing systems (TPS) provide a novel, minimally invasive approach in which a miniaturized, leadless pacemaker (PM) is transfemorally implanted in the right ventricle. Purpose: We sought to assess the Health Related Quality of Life (HRQoL) impact, patient satisfaction and mobility restrictions following TPS in a large prospective multicenter clinical trial. Methods: Patients with a single‐chamber pacing indication who underwent a Micra TPS implantation between December 2013 and May 2015 were included. HRQoL impact was evaluated using the SF‐36 questionnaire at baseline, 3 and 12 months. Patient satisfaction was assessed using a 3‐item questionnaire determining recovery, activity level, and esthetic appearance at 3 months. Implanting physicians compared the patient mobility restrictions for TPS to traditional PM therapy. Results: A total of 720 patients were implanted with a TPS (76±11 years (range: 19‐94); 59% male). Of these patients, 702 (98%), 681 (95%) and 635 (88%) completed the SF‐36 at baseline, 3 and 12 months, respectively. Improvements were observed at 3 and 12 months in all SF‐36 domains and all attained statistical significance. (Figure 1) Of 693 patients who completed the patient satisfaction questionnaire, 96%, 91%, 74% were (very) satisfied with their esthetic appearance, recovery, and level of activity, respectively. TPS discharge instructions were rated less restrictive in 49%, equally restrictive in 47%, and more restrictive in 4% of cases compared to traditional PM systems. (Figure presented) Conclusions: TPS resulted in post‐implant HRQoL improvements at 3 and 12 months, and high levels of patient satisfaction at 3 months. Further, TPS was associated with less mobility restrictions compared to traditional PM systems.