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  1. Fulltext A leadless ventricular pacemaker providing atrioventricular synchronous pacing in the real-world setting: 12-Month results from the Micra AV post-approval registry
    Garweg C, Chinitz JS, Marijon E, Haeberlin A, Winter S, Iacopino S, et al.
    Heart Rhythm, 2024 Jun 13.
    PMID: 38878939 DOI: 10.1016/j.hrthm.2024.06.008
    BACKGROUND: Advances in leadless pacemaker technology have enabled accelerometer-based atrioventricular (AV) synchronous pacing by sensing atrial mechanical contraction.

    OBJECTIVE: The purpose of this study was to report the performance of the Micra AV leadless pacemaker from the worldwide Micra AV post-approval registry (PAR) through 12 months.

    METHODS: The Micra AV PAR is a prospective, single-arm, observational registry designed to assess the safety and effectiveness of Micra AV in a real-world setting. For the present interim analysis, major complications and system revisions through 12 months were summarized and compared to a historical cohort of 2667 patients implanted with a transvenous dual-chamber pacing system.

    RESULTS: The device was successfully implanted in 796 of 801 patients (99.4%) at 97 centers in 19 countries. Micra AV patients were older (74.1 years vs 71.1 years; P < .0001) with a higher incidence of renal disease (22.3% vs 9.8%; P < .0001) compared with transvenous dual-chamber patients. Through 12 months, the major complication rate was 3.7% in Micra AV patients compared with 8.8% in transvenous dual-chamber patients (hazard ratio 0.42; 95% confidence interval 0.28-0.61; P < .001). The system revision rate was 1.5% in Micra AV patients compared with 5.5% for transvenous dual-chamber patients (hazard ratio 0.25; 95% confidence interval 0.13-0.47; P < .001); this reduction was largely driven by the absence of lead dislodgments requiring revision. The median AV synchrony index was 79.4% (interquartile range 65.2%-86.4%) in patients paced >90%.

    CONCLUSION: The Micra AV leadless pacemaker was implanted with a high rate of success in patients with multiple comorbidities, with a significantly lower rate of complications and system revisions through 12 months compared to a historical cohort of patients with transvenous dual-chamber pacemakers.

  2. Fulltext Pest categorisation of Hishimonus phycitis
    EFSA Panel on Plant Health (PLH), Jeger M, Bragard C, Caffier D, Candresse T, Chatzivassiliou E, et al.
    EFSA J, 2017 Oct;15(10):e05037.
    PMID: 32625321 DOI: 10.2903/j.efsa.2017.5037
    The Panel on Plant Health performed a pest categorisation of Hishimonus phycitis (Hemiptera: Cicadellidae) for the EU. H. phycitis is a well-defined species, occurring in tropical and subtropical Asian countries from Iran to Malaysia. H. phycitis is polyphagous. Hosts of particular relevance to the EU include Citrus spp. and Solanum melongena. While harmful in its own right as a leafhopper extracting host nutrients through feeding, it is regarded in the Middle East more significantly as a vector of Witches' broom disease of lime phytoplasma, which limits production of Citrus aurantifolia, and in India as a vector of brinjal little-leaf phytoplasma impacting S. melongena yields. H. phycitis is currently regulated by Council Directive 2000/29/EC, listed in Annex II/AI as Hishomonus phycitis (sic). Eggs planted on host plants for planting could provide a pathway for entry into the EU. The EU has eco-climatic conditions that are also found in countries where H. phycitis occurs although it is unknown whether H. phycitis occurs in those areas. There is therefore considerable uncertainty around EU establishment. Any establishment is likely to be limited to the warmest areas around the Mediterranean. As a free-living organism with adults capable of flight, spread within the EU would be possible but confined to the limited area where establishment could occur. Measures are available to inhibit entry via traded commodities (e.g. prohibition on the introduction of Citrus plants for planting; sourcing other hosts from pest free areas). H. phycitis does satisfy all of the criteria that are within the remit of EFSA to assess to be regarded as a Union quarantine pest. It is uncertain if eggs of H. phycitis would carry phytoplasmas into the EU as transovarial transmission from infected females to eggs has not been demonstrated.
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