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  • We hypothesized that CA with a lower

    2019-05-21

    We hypothesized that CA with a lower Zalcitabine setting (20W) and strict monitoring of esophageal temperature at 39°C may prevent esophageal injury, even in patients with a BMI <24.9. The first goal of the current study was to investigate the incidence of esophageal injury after a single procedure using ETM in patients with a BMI <24.9. A secondary goal was to assess the rhythm outcome after a single procedure using ETM as compared to the conventional procedure without the use of ETM.
    Methods
    Results
    Discussion
    Conclusion CA using ETM may reduce the incidence of esophageal injuries, even in patients with a BMI <24.9kg/m2, without compromising the rhythm outcome of the procedure.
    Disclosures
    Conflict of interest
    Acknowledgments
    Introduction Although routine laboratory monitoring is not required during dabigatran treatment, activated partial prothrombin time (aPTT) has often been used as a biomarker for evaluating the safety of dabigatran use in Japan [1,2]. Determining the anticoagulant effect of the drug and/or its concentration might help avoid adverse events, including major bleeding, because the optimum drug concentration varies depending on the patient [3]. Previous studies have shown that the aPTT varies in patients taking dabigatran [1], and in the RE-LY study, a remarkably high aPTT was related to the occurrence of major bleeding [4]. Professional organizations such as the International Society on Thrombosis and Haemostasis and the British Committee for Standards in Haematology recently recognized the need to develop guidelines detailing the appropriate time and method for evaluating patients receiving novel oral anticoagulants using coagulation tests [5]. However, the recommendations [5,6] are based on limited data obtained using different coagulation assays that focused on the relationships between drug concentration and biomarker levels. According to these guidelines [5,6], biomarker levels may be measured just after initiation of dabigatran treatment to ascertain the safety of continuing the drug; the measurement need not be performed frequently because of its stable pharmacokinetic profile. However, in clinical situations, there is a concern that fluctuations in biomarker levels or changes in the clinical condition of patients might increase the frequency of biomarker measurements, and this may result in over monitoring. This multicenter study aimed to identify the optimum frequency of aPTT measurements for patients on therapy with dabigatran in Japan and to determine whether the frequency of the measurements resulted in different outcomes in patients with non-valvular atrial fibrillation (NVAF).
    Methods
    Results
    Discussion Although routine laboratory monitoring is not needed for patients receiving therapy with dabigatran, aPTT has been frequently used as a biomarker of dabigatran usage in Japan [1,2]. Indeed, some studies reported a wide variation in aPTT values of patients under therapy with dabigatran, suggesting the utility of this biomarker in clinical practice [1,2]. Nonetheless, the correlation between the serum dabigatran concentration and aPTT is neither sensitive nor linear [7–9], and the relationship between aPTT and subsequent clinical events is unclear. Although measuring aPTT in patients under therapy with dabigatran has some limitations, this biomarker may provide some valuable information in certain situations, e.g., drug initiation in patients at high risk of bleeding, invasive procedures, and major bleedings. Even in such cases, aPTT measurement is not used for “monitoring” the way prothrombin time/international normalized ratio is used during treatment with warfarin but is used for “checking” bleeding alone. This retrospective study included various frequencies of aPTT measurements and attempted to examine whether repeated assessment of aPTT in the short term affected the subsequent clinical course of the patients. Because of the limited number of patients, we could not assess the effect of repeated assessments on the rates of stroke, systemic embolism, and major bleeding but could only determine its association with discontinuation for any reason and minor bleeding, which was not significant. The pharmacokinetics and pharmacodynamics of dabigatran are stable and different from those of warfarin [10,11]. Therefore, if the initial aPTT value is acceptable, repeated measurements within a short period would add no valuable information. However, when a patient׳s condition changes dramatically, as in the cases of dehydration, renal failure, or congestive heart failure, our finding would not hold true with respect to not performing frequent aPTT measurements after drug initiation.