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Anticoagulation regimens during pregnancy in patients with mechanical heart valves: a protocol for a systematic review and network meta-analysis.

ABSTRACT: INTRODUCTION:Pregnancy in patients with mechanical heart valves (MHVs) is associated with high maternal complications and fetal complications.Anticoagulation treatments serve to decrease their venous clotting risk. Although some anticoagulation regimens have been used for patients during pregnancy with MHVs, no one is definitively superior among different regimens in recent studies. For a better understanding of the clinical treatment which anticoagulation regimen is more effective and safer during the pregnancy in patients with MHVs, a Bayesian network meta-analysis is necessary. METHODS AND ANALYSIS:This protocol has been reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols. Related studies until April 2019 will be searched in the following databases: PubMed, Embase,SinoMed and the using the OVID interface to search for evidence-based medicine reviews. A clinical trial registry (www.ClinicalTrials.gov) was also searched for unpublished trials. Both experimental studies (randomised clinical trials) and observational studies (cohort studies, case-control studies and case series studies) will be included in this study. Quality assessment will be conducted using Cochrane Collaboration's tool or Newcastle-Ottawa Scale based on their study designs. The primary outcomes of interest will be the frequencies of serious maternal and fetal events. The additional outcomes of interest will be adverse maternal events, mode of delivery and adverse fetal events. Pairwise and network meta-analysis will be conducted using R (V.3.4.4, R Foundation for Statistical Computing, Vienna, Austria) and Stata (V.14, StataCorp). The ranking probabilities will be estimated at each possible rank for each anticoagulation regimen using the surface under the cumulative ranking curve. Statistical inconsistency assessment, subgroup analysis, sensitivity analysis and publication bias assessment will be performed. ETHICS AND DISSEMINATION:Either ethics approval or patient consent is not necessary, because this study will be based on literature. The results of this study will be published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER:CRD42019130659.

SUBMITTER: He S

PROVIDER: S-EPMC7045236 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Anticoagulation regimens during pregnancy in patients with mechanical heart valves: a protocol for a systematic review and network meta-analysis.

He Shiwei S Zou Yue Y Li Juan J Liu Jumei J Zhao Li L Yang Hua H Su Zhiying Z Ye Huiming H

BMJ open 20200210 2

<h4>Introduction</h4>Pregnancy in patients with mechanical heart valves (MHVs) is associated with high maternal complications and fetal complications.Anticoagulation treatments serve to decrease their venous clotting risk. Although some anticoagulation regimens have been used for patients during pregnancy with MHVs, no one is definitively superior among different regimens in recent studies. For a better understanding of the clinical treatment which anticoagulation regimen is more effective and s ...[more]

PMID: 32047017

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Project description:BackgroundAdvances in surgical technique, prosthetic heart valve design, and anticoagulation have contributed to an overall improvement in morbidity and mortality in women with heart valve prostheses as well as increased feasibility of pregnancy. Previous work investigating the pregnancies of women with prosthetic valves has been directed largely toward understanding the influence of anticoagulation regimen. There has been little investigation on maternal and infant outcomes. The objective of this systematic review will be to assess the outcomes of pregnancy in women with heart valve prostheses in contemporary populations.Methods/designA systematic search of Medline, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and the Cochrane Library will be undertaken. Article titles and abstracts will be evaluated by two reviewers for potential relevance. Studies that include pregnancies occurring from 1995 onwards and where there are six or more pregnancies in women with heart valve prostheses included in the study population will be reviewed for potential inclusion. Primary outcomes of interest will be mortality (maternal and perinatal). Secondary outcomes will include other pregnancy outcomes. No language restrictions will be applied. Methodological quality and heterogeneity of studies will be assessed. Data extraction from identified articles will be undertaken by two independent reviewers using a uniform template. Meta-analyses will be performed to ascertain risk of adverse events and, where numbers are sufficient, by type of prosthesis and location as well as other subgroup analyses.DiscussionEstimates of the risk of adverse events in recent pregnancies of women with heart valve prosthesis will provide better information for counselling and decision making. Given the improvements in prognosis of heart valve prosthesis recipients and the paucity of definitive data regarding optimal pregnancy management for these women, review of this topic is pertinent.Review registrationThis protocol has been registered with the international prospective register of systematic reviews (PROSPERO) as number CRD42013006187, accessible online at http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42013006187#.Utk7qNJ9Lf8.

Project description:Aims:Evidence is lacking regarding acute anticoagulation management in patients after intracerebral haemorrhage (ICH) with implanted mechanical heart valves (MHVs). Our objective was to investigate anticoagulation reversal and resumption strategies by evaluating incidences of haemorrhagic and thromboembolic complications, thereby defining an optimal time-window when to restart therapeutic anticoagulation (TA) in patients with MHV and ICH. Methods and results:We pooled individual patient-data (n = 2504) from a nationwide multicentre cohort-study (RETRACE, conducted at 22 German centres) and eventually identified MHV-patients (n = 137) with anticoagulation-associated ICH for outcome analyses. The primary outcome consisted of major haemorrhagic complications analysed during hospital stay according to treatment exposure (restarted TA vs. no-TA). Secondary outcomes comprised thromboembolic complications, the composite outcome (haemorrhagic and thromboembolic complications), timing of TA, and mortality. Adjusted analyses involved propensity-score matching and multivariable cox-regressions to identify optimal timing of TA. In 66/137 (48%) of patients TA was restarted, being associated with increased haemorrhagic (TA = 17/66 (26%) vs. no-TA = 4/71 (6%); P < 0.01) and a trend to decreased thromboembolic complications (TA = 1/66 (2%) vs. no-TA = 7/71 (10%); P = 0.06). Controlling treatment crossovers provided an incidence rate-ratio [hazard ratio (HR) 10.31, 95% confidence interval (CI) 3.67-35.70; P < 0.01] in disadvantage of TA for haemorrhagic complications. Analyses of TA-timing displayed significant harm until Day 13 after ICH (HR 7.06, 95% CI 2.33-21.37; P < 0.01). The hazard for the composite-balancing both complications, was increased for restarted TA until Day 6 (HR 2.51, 95% CI 1.10-5.70; P = 0.03). Conclusion:Restarting TA within less than 2 weeks after ICH in patients with MHV was associated with increased haemorrhagic complications. Optimal weighing-between least risks for thromboembolic and haemorrhagic complications-provided an earliest starting point of TA at Day 6, reserved only for patients at high thromboembolic risk.

Project description:BackgroundPatients with mechanical heart valves are usually maintained on anticoagulation therapy. However, after a spontaneous intracerebral hemorrhage event, administration of anticoagulants is temporarily ceased, and it remains unclear when to restart anticoagulation therapy.MethodsA cohort study was conducted to investigate the optimal time for restarting anticoagulation in patients with mechanical heart valves after spontaneous intracerebral hemorrhage. All patients with mechanical valves who experienced spontaneous cerebral hemorrhage and were admitted to the Second Affiliated Hospital of the Zhejiang University Medical School between 2013 and 2018 were retrospectively enrolled in this study. The patient electronic medical records were reviewed and the correlation between the time of restarting anticoagulation (within 3 days or more than 3 days after hemorrhage) and patient prognosis was assessed.ResultsA total of 40 patients with mechanical heart valves who experienced spontaneous cerebral hemorrhage were enrolled in this study. All patients were given oral warfarin anticoagulant therapy prior to admission (1.5-3.25 mg). After admission, patients were administered fresh frozen plasma and/or vitamin K1 to reverse anticoagulation. Out of the 16 patients (40%) who underwent surgical intervention, 4 died from cerebral hemorrhage deterioration during the hospital stay and did not restart anticoagulant therapy. Anticoagulant therapy was resumed within 3 days for 18 patients and more than three days after hemorrhage for the other 18 patients. After discharge, patients were followed up for 12 months or more. Unfortunately, during this period, 17% of patients (6/36) died.ConclusionsDefinitive hemostatic measures can be as an important factor in the clinical resumption of anticoagulation. Halting anticoagulant therapy for 3 to 7 days may be safe. It is recommended that low molecular heparin be administered within 3 days as a bridge treatment, combine with warfarin anticoagulant therapy within 1 week after hemorrhage.

Dataset Information

Anticoagulation regimens during pregnancy in patients with mechanical heart valves: a protocol for a systematic review and network meta-analysis.

Publications

Anticoagulation regimens during pregnancy in patients with mechanical heart valves: a protocol for a systematic review and network meta-analysis.

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