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This complaint is from a literature source.The following literature cite has been reviewed: sairaku a, morishima n, amioka m, maeda j, watanabe y, nakano y.Does atrial fibrillation ablation worsen preexisting anemia? another anemia paradox in doac era.J cardiol.2021 nov;78(5):382-387.Doi: 10.1016/j.Jjcc.2021.06.007.Epub 2021 jul 10.Pmid: 34256966.No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's ref.#(b)(4).
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This complaint is from a literature source.The following literature cite has been reviewed: sairaku a, morishima n, amioka m, maeda j, watanabe y, nakano y.Does atrial fibrillation ablation worsen preexisting anemia? another anemia paradox in doac era.J cardiol.2021 nov;78(5):382-387.Doi: 10.1016/j.Jjcc.2021.06.007.Epub 2021 jul 10.Pmid: 34256966.Objective/methods/study data: background: there is a concern about worsening anemia after atrial fibrillation (af) ablation in anemic patients.We aimed to clarify whether or not patients with anemia who are on an oral anticoagulant therapy are more likely to lose blood after af ablation.Methods: we studied af patients in 3 cardiovascular centers who skipped a single dose of a direct oral anticoagulant prior to the ablation, and compared the drop in the hemoglobin level 24 hours after the procedure and bleeding complications between the patients with and without preexisting anemia.Results: we identified 183 (15.7%) patients with anemia at baseline out of 1163 patients.The reduction in the hemoglobin level (-0.39±0.71 vs.-0.93±0.9 g/dl; p<0.001) was smaller in the anemic than non-anemic patients.A fall in the hemoglobin level of =2 g/dl, which is a guideline-defined significant hemoglobin drop, was less common in anemic patients (1.6% vs.11.3%; p<0.001).A female gender [odds ratio (or) 1.62, confidence interval (ci) 1.07-2.45; p=0.02], persistent or long-standing persistent versus paroxysmal af (or 1.67, ci 1.13-2.49; p=0.01), orbit score =3 (or 3.5, ci 1.34-8.94; p=0.01), and preexisting anemia (or 0.02, ci 0.004-0.14; p<0.001) were independently associated with the fall in the hemoglobin level of =2 g/dl.No difference was noted in the rate of major bleeding complications (1.6% vs.1.2%; p=0.72).Conclusions: paradoxically, patients with preexisting anemia may be less likely to lose blood following af ablation.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch.Other biosense webster concomitant devices that were also used in this study: lasso catheter.Non-biosense webster concomitant devices that were also used in this study: n/a.Adverse event(s) and provided interventions: 15 major bleeding , 8 minor bleeding ,10 cardiac tamponade 1 retroperitoneal bleeding ,2 ischemic stroke , and 1 hemothorax.There was no note of intervention or prolonged hospitalization.
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