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Results of transvenous lead extraction of coronary sinus leads in patients with cardiac resynchronization therapy

Chinese Medical Journal 2013年第24期126卷 4703-4706页

作者： Christoph T. Starck Starck, Etem Caliska holger klein Jan Steffel Felix Schoenrath Volkmar Falk Clinic of Cardiac and Vascular SurgeryClinic of Cardiology Clinic of Cardiac and Vascular Surgery University Hospital Zurich Zurich Switzerland

Background The need for transvenous lead extraction procedures of coronary sinus （CS） leads is increasing due to rising numbers of implanted cardiac resynchronization therapy devices during the past decade. Methods From January 2009 to June 2013, 27 CS leads were scheduled for extraction in 27 patients （mean age （63.1±14.6） years）. Indications for lead extraction were infection in 13 and lead dysfunction in 14 cases. Isolated extraction of CS leads was performed in eight, extraction of multiple leads in 19 cases. Among leads with an implant time of 〉12 months （n=19） mean implant duration （MID） was （46.4±15.2）（12-76） months. Groups were formed depending on infectious or non-infectious indications （INF vs. Non-INF）, and the use or non-use of extraction tools （ET1 vs. ET0）. Results Among patients with an implant duration of 〉12 months, complete procedural success was 94.7% and clinical success 100%. Operative mortality was zero. In the INF versus NON-INF groups complete procedural success （100% vs. 91.7%, P=0.43）, mean number of required extraction tools （0.7 （0-2） vs. 0.9 （0-3）, P=0.65） and MID （49.1±15.0 vs. 44.7±15.8, P=0.83） did not differ significantly. Comparing the groups ET1 and ET0 showed no significant differences in complications （n=l vs. n=l, P=-0.81） and MID （47.0±17.5 vs. 45.5±12.6, P=0.71）. Conclusions In specialized centers transvenous lead extraction of coronary sinus leads with a mean implant duration of almost four years can be performed safely and effectively. Neither non-infectious indications nor the use of extraction tools negatively affected the outcome of the procedure.

关键词： lead extraction coronary sinus leads pacemaker implantable cardioverter defibrillator,cardiac resynchronization therapy

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Which Endpoints Can Be Reliably Assessed in Semi-field Pollinator Species Testing without Estimating False Positive or False Negative？ MDD’s and Replicates Issue

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Journal of Agricultural Science and Technology(A) 2018年第3期8卷 142-161页

作者： Marco Pompeo Candolfi holger Bargen Sigrun Bocksch Olaf klein Marco kleinhenz Silvio Knaebe Bronislawa Szczesniak Eurofins Agroscience Services Ecotox GmbH Eutinger Str. 24 Niefern-Oschelbronn 75223 Germany

Statistical power, number of replicates and experiment complexity of semi-field and field studies on Apis and non-Apis bee species has become a major issue after publication of the draft European Food Safety Authority （EFSA） Guidance on risk assessment of plant protection products （PPP） on bees （Apis mellifera, Bombus spp. and solitary bees）. According to this guidance document, field studies have to be designed to be able to detect significance differences as low as 7% for certain endpoints such as reduction in colony size. This will require an immense number of replicates which is obviously not feasible. In the present study, key endpoints such as mortality, termination rate and number of brood cells in honeybee studies, cocoon production and flight activity in solitary bee studies and number of gynes in bumble bee studies （just to mention some of the endpoints considered） in semi-field studies were analyzed, with Apis mellifera, Bombus terrestris and Osmia bicornis during the past five years （2013-2017）. The results indicate huge differences in the percentage minimal detectable differences （%MDDs）（MDD expressed as median of control value of the endpoint in percent） depending on endpoint and species tested. For honeybee semi-field studies, the lowest %MDDs recorded were between 10% and 15% for the endpoints foraging, number of brood cells and colony strength. The highest %MDDs were observed for the endpoint termination rate, with a %MDD of almost 50%. For the endpoints in bumble bee semi-field studies the %MDDs varied between 17% for bumble bee colony weight and 53% for average mortality during the exposure period in the tunnel. The %MDD for the number of gynes （young queens） was slightly below 25%. For the semi-field solitary bee test system, the %MDDs for the measured endpoints seem to be lower than those for the other two species tested. The %MDDs for the endpoints hatching of offspring, nest occupation and number of cocoons were 8%, 13% and 14%, respective

关键词： Apis mellifera Bombus terrestris Osmia bicornis OECD75 minimal detectable difference (MDD) statistical power

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