Dataset Information

Prosthetic heart valves in pregnancy: a systematic review and meta-analysis protocol.

ABSTRACT:

Background

Advances 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/design

A 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.

Discussion

Estimates 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 registration

This 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.

SUBMITTER: Lawley CM

PROVIDER: S-EPMC3913632 | biostudies-literature | 2014 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Prosthetic heart valves in pregnancy: a systematic review and meta-analysis protocol.

Lawley Claire M CM Lain Samantha J SJ Algert Charles S CS Ford Jane B JB Figtree Gemma A GA Roberts Christine L CL

Systematic reviews 20140121

<h4>Background</h4>Advances 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 object ...[more]

PMID: 24444192

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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.

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.

Dataset Information

Prosthetic heart valves in pregnancy: a systematic review and meta-analysis protocol.

Background

Methods/design

Discussion

Review registration

Publications

Prosthetic heart valves in pregnancy: a systematic review and meta-analysis protocol.

Similar Datasets

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