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      Pregnancy Outcomes in Women With Mechanical Valve Prostheses Using Vitamin K Antagonist Therapy: The Experience of the Salam Centre for Cardiac Surgery in Sudan

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          Abstract

          Pregnancy and childbirth on anticoagulants after mechanical heart valve replacement present a high risk of complications for both mother and baby. On top of pregnancy worsening the mother's cardiac function, anticoagulant therapy itself is a crucial problem. A safe and effective anticoagulation regimen for both mother and fetus is not possible. The most effective drugs for preventing valve thrombosis are VKAs, whose dosage needs to be adjusted with frequent INR checks. Moreover, VKAs can have embryopathic and teratogenic action. Patients in follow-up and anticoagulant treatment at the Salam Centre for Cardiac Surgery in Sudan live spread out over a large area where transport to the Center is generally difficult; pregnancy treatment has, therefore, been adapted to the limitations of reality. Pregnancy is discouraged and contraception and therapeutic abortion are recommended, but this guidance frequently goes unheeded. Here we describe maternal and fetal outcomes in 307 consecutive pregnancies recorded by staff at the oral anticoagulant clinic (OAC) from April 2017 to November 2021. Out of 307 pregnancies, there were 15 maternal deaths (4.9%), 24 thrombotic events (7.8%) and 22 major bleedings (7.2%). Fifty pregnancies (16.3%) were terminated by therapeutic abortion. Only 47.6% of pregnancies had good maternal and neonatal outcomes. Data clearly show that, due to the complexity of pregnancy in women with mechanical heart valves and the scarcity of tertiary healthcare services in the area where patients live, maternal mortality is at an unacceptable level and requires a structured, multi-disciplinary intervention.

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          Most cited references19

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          Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients.

          Summary. A variety of definitions of major bleeding have been used in published clinical studies, and this diversity adds to the difficulty in comparing data between trials and in performing meta-analyses. In the first step towards unified definitions of bleeding complications, the definition of major bleeding in non-surgical patients was discussed at the Control of Anticoagulation Subcommittee of the International Society on Thrombosis and Haemostasis. Arising from that discussion, a definition was developed that should be applicable to studies with all agents that interfere with hemostasis, including anticoagulants, platelet function inhibitors and fibrinolytic drugs. The definition and the text that follows have been reviewed and approved by the cochairs of the subcommittee and the revised version is published here. The intention is to also seek approval of this definition from the regulatory authorities.
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            2018 ESC Guidelines for the management of cardiovascular diseases during pregnancy

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              2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines

              This executive summary of the valvular heart disease guideline provides recommendations for clinicians to diagnose and manage valvular heart disease as well as supporting documentation to encourage their use. A comprehensive literature search was conducted from January 1, 2010, to March 1, 2020, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, Cochrane, Agency for Healthcare Research and Quality Reports, and other selected database relevant to this guideline. Many recommendations from the earlier valvular heart disease guidelines have been updated with new evidence and provides newer options for diagnosis and treatment of valvular heart disease. This summary includes only the recommendations from the full guideline which focus on diagnostic work-up, the timing and choice of surgical and catheter interventions, and recommendations for medical therapy. The reader is referred to the full guideline for graphical flow charts, text, and tables with additional details about the rationale for and implementation of each recommendation, and the evidence tables detailing the data considered in developing these guidelines.
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                Author and article information

                Contributors
                Journal
                Front Pediatr
                Front Pediatr
                Front. Pediatr.
                Frontiers in Pediatrics
                Frontiers Media S.A.
                2296-2360
                08 July 2022
                2022
                : 10
                : 918547
                Affiliations
                [1] 1Emergency ONG ONLUS , Milan, Italy
                [2] 2Federazione Centri per la Diagnosi Della Trombosi e la Sorveglianza Delle Terapie Antitrombotiche (FCSA) , Milan, Italy
                [3] 3Salam Centre for Cardiac Surgery , Khartoum, Sudan
                [4] 4Università Degli Studi , Milan, Italy
                [5] 5Laboratory of Clinical Epidemiology, Department of Public Health, Istituto di Ricerche Farmacologiche Mario Negri IRCCS , Milan, Italy
                Author notes

                Edited by: Sarah Nordmeyer, Charité Universitätsmedizin Berlin, Germany

                Reviewed by: Antonia Schulz, Deutsches Herzzentrum Berlin, Germany; Viktoria Weixler, Deutsches Herzzentrum Berlin, Germany

                *Correspondence: Sofia Gatti sofia.gatti@ 123456emergency.it

                This article was submitted to Pediatric Cardiology, a section of the journal Frontiers in Pediatrics

                Article
                10.3389/fped.2022.918547
                9309277
                35899137
                7ae78c1d-9801-44ff-a6d7-b83f7937129c
                Copyright © 2022 Erba, Gatti, Hassan, Langer, Chatenoud, Portella and Baiocchi.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 12 April 2022
                : 17 June 2022
                Page count
                Figures: 0, Tables: 2, Equations: 0, References: 19, Pages: 6, Words: 4444
                Categories
                Pediatrics
                Original Research

                anticoagulants-therapeutic use,pregnancy,mechanical heart valves,humanitarian medicine,warfarin,maternal death,salam centre for cardiac surgery

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