Anticoagulation for pregnant women with mechanical heart valves: a systematic review and meta-analysis.
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ABSTRACT: Aims
To review maternal and foetal outcomes in women with mechanical heart valves (MHVs) treated with vitamin-K antagonists (VKAs), first-trimester heparin followed by VKAs (sequential treatment), low molecular weight heparin (LMWH) and unfractionated heparin (UFH) during pregnancy, in order to inform practice.Methods and results
Medline, Embase and Central were searched from inception until February 2016. Two reviewers independently screened 1786 titles, reviewed 110 full-texts and extracted data and assessed risk-of-bias from 46 articles. Pooled incidence (95% confidence intervals) was calculated for maternal and foetal outcomes. Included studies had a moderate or high risk-of-bias. With VKAs, sequential treatment and LMWH, maternal mortality occurred in 0.9% (0.4-1.4), 2.0% (0.8-3.1) and 2.9% (0.2-5.7), thromboembolic complications in 2.7% (1.4-4.0), 5.8% (3.8-7.7) and 8.7% (3.9-13.4), livebirths in 64.5% (48.8-80.2), 79.9% (74.3-85.6) and 92.0% (86.1-98.0) and anticoagulant-related foetal/neonatal adverse events (embryopathy or foetopathy) in 2.0% (0.3-3.7), 1.4% (0.3-2.5) and 0%, respectively. When UFH is used throughout pregnancy, 11.2% (2.8-19.6) suffered thromboembolic complications. Foetal loss and adverse events occurred with first-trimester warfarin doses ≤ 5 mg/day, although there were more livebirths [83.6% (75.8-91.4) vs. 43.9% (32.8-55.0)] and fewer foetal anomalies [2.3% (0.7-4.0) vs. 12.4% (3.3-21.6)] with lower doses than with warfarin > 5 mg/day.Conclusions
VKAs are associated with fewest maternal complications but also with fewest livebirths. Sequential treatment does not eliminate anticoagulant-related foetal/neonatal adverse events. LMWH is associated with the highest number of livebirths. The safety of UFH throughout pregnancy and first-trimester warfarin ≤ 5 mg/day remains unconfirmed.
SUBMITTER: D'Souza R
PROVIDER: S-EPMC5429939 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundAnticoagulation for mechanical heart valves during pregnancy is essential to prevent thromboembolic events. Each regimen has drawbacks with regard to maternal or fetal risk.ObjectivesThis meta-analysis sought to estimate and compare the risk of adverse maternal and fetal outcomes in pregnant women with mechanical heart valves who received different methods of anticoagulation.MethodsStudies were identified using a Medline search including all publications up to June 5, 2016. Study inclusion required reporting of maternal death, thromboembolism, and valve failure, and/or fetal spontaneous abortion, death, and congenital defects in pregnant women treated with any of the following: 1) a vitamin K antagonist (VKA) throughout pregnancy; 2) low-molecular-weight heparin (LMWH) throughout pregnancy; 3) LMWH for the first trimester, followed by a VKA (LMWH and VKA); or 4) unfractionated heparin for the first trimester, followed by a VKA (UFH and VKA).ResultsA total of 800 pregnancies from 18 publications were included. Composite maternal risk was lowest with VKA (5%), compared with LMWH (16%; ratio of averaged risk [RAR]: 3.2; 95% confidence interval [CI]: 1.5 to 7.5), LMWH and VKA (16%; RAR: 3.1; 95% CI: 1.2 to 7.5), or UFH and VKA (16%; RAR: 3.1; 95% CI: 1.5 to 7.1). Composite fetal risk was lowest with LMWH (13%; RAR: 0.3; 95% CI: 0.1 to 0.8), compared with VKA (39%), LMWH and VKA (23%), or UFH and VKA (34%). No significant difference in fetal risk was observed between women taking ≤5 mg daily warfarin and those with an LMWH regimen (RAR: 0.9; 95% CI: 0.3 to 2.4).ConclusionsVKA treatment was associated with the lowest risk of adverse maternal outcomes, whereas the use of LMWH throughout pregnancy was associated with the lowest risk of adverse fetal outcomes. Fetal risk was similar between women taking ≤5 mg warfarin daily and women treated with LMWH.
| S-EPMC5457289 | biostudies-literature
Project description: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.
| S-EPMC7045236 | biostudies-literature
Project description:BackgroundMany patients with end-stage kidney disease (ESKD) have valvular heart disease requiring surgery. The optimal prosthetic valve is not established in this population. We performed a systematic review and meta-analysis to assess outcomes of patients with dialysis-dependent ESKD who received mechanical or bioprosthetic valves.MethodsWe searched Cochrane Central, Medline and Embase from inception to January 2020. We performed screening, full-text assessment, risk of bias and data collection, independently and in duplicate. Data were pooled using a random-effects model.ResultsWe identified 28 observational studies (n = 9857 patients, including 6680 with mechanical valves and 3717 with bioprosthetic valves) with a median follow-up of 3.45 years. Twenty-two studies were at high risk of bias and 1 was at critical risk of bias from confounding. Certainty in evidence was very low for all outcomes except bleeding. Mechanical valves were associated with reduced mortality at 30 days (relative risk [RR] 0.79, 95% confidence interval [CI] 0.65-0.97, I 2 = 0, absolute effect 27 fewer deaths per 1000) and at 6 or more years (mean 9.7 yr, RR 0.83, 95% CI 0.72-0.96, I 2 = 79%, absolute effect 145 fewer deaths per 1000), but increased bleeding (incidence rate ratio [IRR] 2.46, 95% CI 1.41-4.27, I 2 = 59%, absolute effect 91 more events per 1000) and stroke (IRR 1.63, 95% CI 1.21-2.20, I 2 = 0%, absolute effect 25 more events per 1000).ConclusionMechanical valves were associated with reduced mortality, but increased rate of bleeding and stroke. Given very low certainty for evidence of mortality and stroke outcomes, patients and clinicians may choose prosthetic valves based on factors such as bleeding risk and valve longevity.Study registrationPROSPERO no. CRD42017081863.
| S-EPMC9293484 | biostudies-literature
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.
| S-EPMC3913632 | biostudies-literature
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.
| S-EPMC5950928 | biostudies-literature
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.
| S-EPMC8848443 | biostudies-literature
Project description:Body image dissatisfaction refers to negative thoughts and feelings individuals have towards their own body appearance and this is thought to be affected by the physiological changes that occur during pregnancy. There are two main conflicting theories as to the effect pregnancy has on body image dissatisfaction: 1) Pregnancy related changes are in direct conflict with social ideas of female beauty (e.g. weight gain) and so increase body image dissatisfaction; 2) Due to changes in expectations of bodily appearance during pregnancy, women are liberated from social ideals at this time and thus body image dissatisfaction would decrease. This study aimed to assess these theories by synthesising the current literature. Six databases were searched, and 2,017 study abstracts were screened based on strict inclusion and exclusion criteria. Following screening and quality assessment by two blind reviewers, 17 studies (comprising 17 effect sizes) were subject to full review and meta-analysis following PRISMA guidelines. These studies included cross-sectional, longitudinal and retrospective designs. Results varied with some studies showing women to feel more positive about their body during pregnancy, others showing a more negative body experience and yet others showing no statistical difference. Overall the analysis showed no statistical difference in body image dissatisfaction between pregnant women and non-pregnant women (p = 0.39). Any changes that do occur are heterogeneous and likely to be largely dependent on the individual experience as well as moderator variables and other factors such as differences in methodology of research studies. Studies in this field of research would benefit from more explicit and complete reporting of data and key variables, in order to allow early intervention for women who display body image dissatisfaction in pregnancy.
| S-EPMC10548696 | biostudies-literature
Project description:BackgroundThyroid dysfunction during pregnancy is associated with adverse outcomes for both mother and fetus. The present meta-analysis was conducted to evaluate thyroid dysfunction in Iranian pregnant women.MethodsWe registered this review at PROSPERO (registration number: CRD42020166655). The research steps in this systematic review and meta-analysis were performed according to the MOOSE protocol, and finally, reports were provided based on the PRISMA guidelines. The literature search was performed in October 2019 using the international online databases, including Web of Science, Ovid, Science Direct, Scopus, EMBASE, PubMed/Medline, Cochrane Library, EBSCO, CINAHL, Google Scholar as well as national databases were reviewed. Data were extracted after applying the inclusion and exclusion criteria and qualitative evaluation of the studies. I2 index and Q test were used to assess differences in studies. All analyses were performed using Comprehensive Meta-Analysis Software. P-value less than 0.05 was considered statistically significant. We identified 1261 potential articles from the databases, and 426 articles remained after removing the duplicate and unrelated studies. After evaluating the full text, 52 articles were removed.ResultsFinally, 19 eligible studies including 17,670 pregnant women included for meta-analysis. The prevalence of thyroid dysfunction in Iranian pregnant women was 18.10% (95%CI: 13.89-23.25). The prevalence of hypothyroidism, clinical hypothyroidism, and subclinical hypothyroidism in Iranian pregnant women was respectively estimated to be 13.01% (95%CI: 9.15-18.17), 1.35% (95%CI: 0.97-1.86) and 11.90% (95%CI: 7.40-18.57). The prevalence of hyperthyroidism, clinical hyperthyroidism, and subclinical hyperthyroidism in Iranian pregnant women was respectively estimated to be 3.31% (95%CI: 1.62-6.61), 1.06% (95%CI: 0.61-1.84) and 2.56% (95%CI: 0.90-7.05). The prevalence of anti-thyroperoxidase antibody was estimated to be 11.68% (95%CI: 7.92-16.89).ConclusionThe results of this meta-analysis showed a high prevalence of thyroid disorders, especially hypothyroidism. The decision to recommend thyroid screening during pregnancy for all women is still under debate, because the positive effects of treatment on pregnancy outcomes must be ensured. On the other hand, evidence about the effect of thyroid screening and treatment of thyroid disorders on pregnancy outcomes is still insufficient. Nevertheless, a large percentage of general practitioners, obstetricians and gynecologists perform screening procedures in Iran.
| S-EPMC7386166 | biostudies-literature
Project description:Background Guidelines for choice of prosthetic heart valve in people of reproductive age are not well established. Although biologic heart valves (BHVs) have risk of deterioration, mechanical heart valves (MHVs) require lifelong anticoagulation. This study aimed to characterize the association of prosthetic valve type with maternal and fetal outcomes in pregnant patients. Methods and Results Using the 2008 to 2019 National Inpatient Sample, we identified all adult patients hospitalized for delivery with prior heart valve implantation. Multivariable regressions were used to analyze the primary outcome, major adverse cardiovascular events, and secondary outcomes, including maternal and fetal complications, length of stay, and costs. Among 39 871 862 birth hospitalizations, 4152 had MHVs and 874 had BHVs. Age, comorbidities, and cesarean birth rates were similar between patients with MHVs and BHVs. The presence of a prosthetic valve was associated with over 22-fold increase in likelihood of major adverse cardiovascular events (MHV: adjusted odds ratio, 22.1 [95% CI, 17.3-28.2]; BHV: adjusted odds ratio, 22.5 [95% CI, 13.9-36.5]) as well as increased duration of stay and hospitalization costs. However, patients with MHVs and BHVs had no significant difference in the odds of any maternal outcome, including major adverse cardiovascular events, hypertensive disease of pregnancy, and ante/postpartum hemorrhage. Similarly, fetal complications were more likely in patients with valve prostheses, including a 4-fold increase in odds of stillbirth, but remained comparable between MHVs and BHVs. Conclusions Patients hospitalized for delivery with prior valve replacement carry substantial risk of adverse maternal and fetal events, regardless of valve type. Our findings reveal comparable outcomes between MHVs and BHVs.
| S-EPMC10227312 | biostudies-literature
Project description:BackgroundValve replacement surgery is the definitive management strategy for patients with severe valvular disease. However, valvular conduits currently in clinical use are associated with significant limitations. Tissue-engineered (decellularized) heart valves are alternative prostheses that have demonstrated promising early results. The purpose of this systematic review and meta-analysis is to perform robust evaluation of the clinical performance of decellularized heart valves implanted in either outflow tract position, in comparison with standard tissue conduits.MethodsSystematic searches were conducted in the PubMed, Scopus, and Web of Science databases for articles in which outcomes between decellularized heart valves surgically implanted within either outflow tract position of human subjects and standard tissue conduits were compared. Primary endpoints included postoperative mortality and reoperation rates. Meta-analysis was performed using a random-effects model via the Mantel-Haenszel method.ResultsSeventeen articles were identified, of which 16 were included in the meta-analysis. In total, 1418 patients underwent outflow tract reconstructions with decellularized heart valves and 2725 patients received standard tissue conduits. Decellularized heart valves were produced from human pulmonary valves and implanted within the right ventricular outflow tract in all cases. Lower postoperative mortality (4.7% vs. 6.1%; RR 0.94, 95% CI: 0.60-1.47; P = 0.77) and reoperation rates (4.8% vs. 7.4%; RR 0.55, 95% CI: 0.36-0.84; P = 0.0057) were observed in patients with decellularized heart valves, although only reoperation rates were statistically significant. There was no statistically significant heterogeneity between the analyzed articles (I2 = 31%, P = 0.13 and I2 = 33%, P = 0.10 respectively).ConclusionsDecellularized heart valves implanted within the right ventricular outflow tract have demonstrated significantly lower reoperation rates when compared to standard tissue conduits. However, in order to allow for more accurate conclusions about the clinical performance of decellularized heart valves to be made, there need to be more high-quality studies with greater consistency in the reporting of clinical outcomes.
| S-EPMC7501674 | biostudies-literature