Health‐related quality of life impact of a transcatheter pacing system. (15th October 2018)

• Record Type: Journal Article
• Authors: Tjong, Fleur V. Y.; Beurskens, Niek E. G.; de Groot, Joris R.; Waweru, Catherine; Liu, Shufeng; Ritter, Philippe; Reynolds, Dwight; Wilde, Arthur A. M.; Knops, Reinoud E.
• Is Part Of: Journal of cardiovascular electrophysiology. Volume 29:Number 12(2018)
• Page Start: 1697
• Page End: 1704
• Publication Date: 2018-10-15
• Subjects: health‐related quality of life -- leadless pacing -- micra transcatheter pacing systems -- pacemaker; Blood vessels -- Physiology -- Periodicals; Electrophysiology -- Periodicals; Heart -- Physiology -- Periodicals; 612.1
• DOI: 10.1111/jce.13726
• Languages: English
• ISSNs: 1045-3873

Abstract

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. We evaluated the health‐related quality of life (HRQoL) impact, patient satisfaction, and activity restrictions following TPS in a large prospective multicenter clinical trial. Methods and Results: Patients who underwent a Micra TPS implantation between December 2013 and May 2015 were included. HRQoL impact was evaluated using the Short‐Form‐36 (SF‐36) questionnaire at baseline, 3, and 12 months. Patient satisfaction was assessed using a three‐item questionnaire determining recovery, activity level, and esthetic appearance at 3 months. Implanting physicians compared the patient activity restrictions for TPS to traditional PM therapy. A total of 720 patients were implanted with a TPS (76 ± 11 years; 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. 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 with traditional PM systems. Conclusions: TPS resulted in postimplant HRQoL improvements at 3 and 12 months, and high levels of patient satisfaction at 3 months. Further, TPS was associated with less activity restrictions compared with traditional PM systems.