PMD1 EFFICACY AND SAFETY OF PACEMAKERS IN THE MANAGEMENT OF PATIENTS WITH BRADYCARDIA — SYSTEMATIC REVIEW OF RANDOMIZED CONTROLLED TRIALS (RCTS)

Abstract

To assess the efficacy and safety of approved pacemaker in the treatment of patients with bradycardia We searched PubMed, Cochrane libraries, and ClinicalTrials.gov databases for the identification of RCTs comparing approved pacemakers in the treatment of bradycardia. The search strategy comprised of different pacemaker and bradycardia. The primary outcomes of interest were pacing rate and the safety outcome especially cardiac death. Two reviewers independently conducted the screening, data abstraction, and the quality assessment. A total of six RCTs evaluating pacemakers and 2803 patients with bradycardia were included. Xiang et al 2016 reported that Qinming8631, a newly developed pacemaker in China, showed effective pacing rate (81.4% vs. 79.5%, p=0.712) vs. Talos DR. AEs rate was 3.53% in trial group and 2.67% in the control group, (p = 1.00). Boriani et al 2014, reported that 2-year incidence of a combined endpoint composed of death, cardiovascular hospitalizations, or permanent AF, occurred in 26.5% Control DDDR patients, in 19.8% DDDRP+MVP patients, and in 21.4% MVP patients. Kerr et al 2004 showed that there was a significantly lower rate of development of atrial fibrillation in the physiological pacing vs. ventricular pacing, with a relative risk reduction of 20.1%. Lamas et al 1998 found that QoL improved significantly after pacemaker implantation (p< 0.001), for ventricular pacing vs. dual chamber but there were no differences between the two pacing modes in pre-specified clinical outcomes. Shandling et al 1992, found that overdrive pacing may reduce incidence of tachyarrhythmias by means of several mechanisms. Lee et al 2003 showed DDDRP pacemaker safe, has accurate AT/AF detection, and provides ATP with 54% efficacy as defined by the device. Our findings demonstrated that technological research in pacemaker field is growing and use of combinations, physiological pacing, and overdrive pacing techniques are also effective ways in the in treatment of bradycardia.