Outcomes after implantation of leadless pacemakers
Research type
Research Study
Full title
Short-term and long-term outcomes after implantation of leadless pacemakers
IRAS ID
314904
Contact name
Archana Rao
Contact email
Sponsor organisation
Liverpool Heart and Chest Hospital, R&D Department
Duration of Study in the UK
10 years, 0 months, 0 days
Research summary
Background: In Europe, leadless pacemakers are implanted since 2015. Large worldwide registries have shown high implant success, low complication rates, and good electrical parameters up to 12 months’ follow-up. However, data are scarce outside the investigational setting and especially for long-term follow-up outcomes such as need for re-interventions or lead/device performance.
Aim: The purpose of this study is to assess the real-world experience regarding long-term clinical safety and efficacy of Micra TPS (transcatheter pacing system) leadless pacemakers as compared to transvenous VVI permanent pacemakers.
Methodology: This is a retrospective multicentre study designed to assess the outcomes of a large sample of consecutive patients undergoing leadless pacemaker implantations. The outcomes of the leadless pacemaker patients’ group will be compared to the ones of transvenous pacemaker patients controls (randomly chosen after propensity score matching for age, sex, and study site). The primary endpoint will be incidence of complications defined as tamponade, pneumothorax, re-interventions (e.g., due to lead dislodgement/perforation), hematoma (pocket or groin), infection, extraction, and all-cause mortality during long term follow-up in MICRA TPS vs transvenous VVI permanent pacemaker patients. Secondary endpoints include 1) Device/lead performance including sensing, pacing, and impedance in MICRA TPS vs transvenous VVI permanent pacemaker patients during long-term follow-up. 2) Descriptive analysis of patient’s characteristics with vs without re-interventions in the MICRA TPS vs transvenous VVI permanent pacemaker groups. 3) Identification of predictive parameters for re-interventions during long term follow-up in MICRA TPS patients. 4) Identifying safety cut-offs at the time of an intervention for variables potentially predicting need for re-interventions during long term follow-up (such as LVEF, sensing, pacing threshold, impedance) MICRA TPS patients. Descriptive analysis of patient’s characteristics of patients with vs without poor device/lead performance in the MICRA TPS vs transvenous VVI permanent pacemaker groups. 5) Identification of predictive parameters for poor device/lead performance during long term follow-up in MICRA TPS patients. 6) Identifying safety cut-offs at the time of an intervention for variables potentially predicting poor device/lead performance during long term follow-up (such as LVEF, sensing, pacing threshold, impedance) in MICRA TPS patients.
Potential significance: It is our hypothesis that leadless pacemaker implantation is similarly safe and effective as transvenous pacemaker implantations. The findings of this study will help guide decision making on utilization of transvenous pacemakers.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
22/PR/0469
Date of REC Opinion
22 Apr 2022
REC opinion
Favourable Opinion