Department of Cardiology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.
Medtronic, Minneapolis, Minnesota.
J Cardiovasc Electrophysiol. 2018 Dec;29(12):1697-1704. doi: 10.1111/jce.13726. Epub 2018 Oct 15.
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.
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.
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.
经导管起搏系统（TPS）提供了一种新颖的微创方法，通过经股静脉植入微型无导线起搏器（PM）到右心室。我们在一项大型前瞻性多中心临床试验中评估了 TPS 对健康相关生活质量（HRQoL）的影响、患者满意度以及对活动限制的影响。
纳入了 2013 年 12 月至 2015 年 5 月期间接受 Micra TPS 植入的患者。使用短式 36 项健康调查简表（SF-36）问卷在基线、3 个月和 12 个月时评估 HRQoL 影响。使用三项问卷在 3 个月时评估患者满意度，确定恢复情况、活动水平和美观度。植入医生将 TPS 患者的活动限制与传统 PM 疗法进行比较。共植入 720 例 TPS（76±11 岁；59%为男性）。其中，702 例（98%）、681 例（95%）和 635 例（88%）分别在基线、3 个月和 12 个月时完成了 SF-36 问卷。在 3 个月和 12 个月时，所有 SF-36 领域均有改善，均具有统计学意义。在完成患者满意度问卷的 693 例患者中，分别有 96%、91%和 74%对美观度、恢复情况和活动水平（非常）满意。与传统 PM 系统相比，TPS 出院医嘱被认为限制较少的占 49%、限制相当的占 47%、限制更多的占 4%。
TPS 在 3 个月和 12 个月时导致植入后 HRQoL 改善，并且在 3 个月时患者满意度高。此外，与传统 PM 系统相比，TPS 与较少的活动限制相关。
