BackgroundWith an ageing population and widening indications for pacemakers implantation, the number of persons carrying an implant is steadily increasing. The routine follow-up is thus a heavy burden for the respective NHS as well as for the patients and their relatives. Most of them of the studies have been performed in densely populated areas and nearby to the hospital. It is thus unknown whether these results could be applied also in rural areas such as Northern Norway with a more scattered population. The aim of this study was to assess the effectiveness of tele-monitoring (TM) in patients with pacemakers regarding reliability, safety and health-related quality of life, compared to traditional follow-up in outpatient clinic in a setting where geographical effects could possible influence the results.MethodsThe NORDLAND study is a controlled, randomized, non-masked clinical trial in pacemaker patients, with data collection carried out during the pre-implant stage and after 6 months. Between August of 2014 and November of 2015, 50 patients were assigned to either a tele-monitoring group (n = 25) or a conventional hospital monitoring (HM) group (n = 25). The EuroQol-5D (EQ-5D) utilities and visual analogue scale (VAS) and the Minnesota Living with Heart Failure Questionnaire (MLHFQ) were used to measure Health-Related Quality of Life. Baseline characteristics and number of hospital visits were also analyzed.ResultsThe baseline characteristics of the two study groups were similar for EQ-5D utilities (TM:0.81; HM:0.76; p = 0.47), EQ-5D VAS (TM: 64.00; HM:64.88; p = 0.86) and the MLHFQ (TM:20.20; HM:28.96; p = 0.07). At the 6 month follow-up, there were no significant differences between the groups in EQ-5D utilities (TM: 0.81; HM: 0.76; p = 0.54) and EQ-5D VAS scores (TM: 72.71; HM: 59.79; p = 0.08). The MLHFQ score was improved in both groups (TM: -4.40; HM: -15.13; p <  0.001). The number of in-office visits was similar in both groups (TM: 1.24 vs HM: 1.12; P = 0.30).ConclusionsThe NORDLAND trial shows that HRQoL is improved after implant in both groups. Without significant differences with regards to effectiveness and safety. In addition, provides a scientifically rigorous method to the field of HRQoL evaluations in patients with pacemakers.Trial registrationClinicalTrials.gov NCT02237404, September 11, 2014.

Background Pre-statin trials reported positive effects of omega-3 fatty acids (n-3 PUFA) in cardiovascular disease (CVD), whereas recent studies and meta-analyses have not reproduced these results. The effect of n-3 PUFA in patients with familial hypercholesterolemia (FH), a group with particularly high risk of CVD, is not well established. Objective We investigated the effect of n-3 PUFA on the early stage of atherosclerosis in FH patients by evaluating in vivo (peripheral arterial tonometry (PAT)) and in vitro (plasma asymmetric dimethylarginine (ADMA) and E-selectin) endothelial function. Methods This was a double blind, placebo-controlled crossover study with 34 FH patients on statin treatment (mean age 46.6 years). In random order, all individuals were treated for three months with high dose n-3 PUFA (2g x2) and three months placebo (olive oil, 2g x2), separated by a three months washout period. Anthropometric data, blood samples and PAT were collected at four time points. Results There were no significant changes in reactive hyperemia index (RHI) measured by PAT after n-3 PUFA compared to placebo, median RHI after n-3 PUFA was 1.98 and after placebo 1.96, p=0.51. No significant changes were detected in the soluble endothelial marker ADMA (in two different assays) when comparing n-3 PUFA and placebo (p=0.92 and 0.14, respectively). Finally, the level of E-selectin did not change significantly during the trial, p=0.26. Conclusion Addition of n-3 PUFA to standard lipid-lowering treatment in genetically verified FH patients did not affect the in vivo endothelial function or soluble endothelial markers.

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