“…Where warfarin exposure occurs in the first trimester, the overall rate of fetal anomaly is around 5–6%, but the precise incidence appears to correlate with total dose 26‐28 . While the use of ‘direct’ oral anticoagulants such as rivaroxaban is contraindicated in pregnancy owing to concerns around fetal toxicity, their use in those with mechanical heart valves is already contraindicated outwith pregnancy 29,30 …”
Section: Anaesthetic Considerations For Valvular Disease In Pregnancymentioning
Key content
Pregnancy‐induced changes in haemodynamic physiology can place considerable strain on cardiac function in some women with valvular disease.
Regurgitant valve lesions are usually better tolerated in pregnancy than stenotic lesions, although the risk of obstetric complications is increased in both.
Pre‐conception counselling is essential for all women with valvular disease.
Optimising anticoagulation is a particular challenge in women with mechanical valves.
Learning objectives
To understand the World Health Organization (WHO) classification of maternal cardiac disease and how this affects counselling regarding decisions around pregnancy for women with valve pathology.
To understand how valve disease affects pregnancy and vice versa.
To gain insight into the anaesthetic and haematological considerations for managing women with valvular disease.
Ethical issues
What is the optimum anticoagulation regimen for women with mechanical heart valves in pregnancy that balances both maternal and fetal risks?
“…Where warfarin exposure occurs in the first trimester, the overall rate of fetal anomaly is around 5–6%, but the precise incidence appears to correlate with total dose 26‐28 . While the use of ‘direct’ oral anticoagulants such as rivaroxaban is contraindicated in pregnancy owing to concerns around fetal toxicity, their use in those with mechanical heart valves is already contraindicated outwith pregnancy 29,30 …”
Section: Anaesthetic Considerations For Valvular Disease In Pregnancymentioning
Key content
Pregnancy‐induced changes in haemodynamic physiology can place considerable strain on cardiac function in some women with valvular disease.
Regurgitant valve lesions are usually better tolerated in pregnancy than stenotic lesions, although the risk of obstetric complications is increased in both.
Pre‐conception counselling is essential for all women with valvular disease.
Optimising anticoagulation is a particular challenge in women with mechanical valves.
Learning objectives
To understand the World Health Organization (WHO) classification of maternal cardiac disease and how this affects counselling regarding decisions around pregnancy for women with valve pathology.
To understand how valve disease affects pregnancy and vice versa.
To gain insight into the anaesthetic and haematological considerations for managing women with valvular disease.
Ethical issues
What is the optimum anticoagulation regimen for women with mechanical heart valves in pregnancy that balances both maternal and fetal risks?
“…MHVs are not suitable for everyone because of the disadvantages of long-term anti-coagulation and poor hemodynamic, although they can be used for a longer period after operation. Compared with MHVs, besides the better biocompatibility and hemodynamics, BHVs can also be suitable for transcatheter heart valve replacement (THVR) which expanded the usage of BHVs in clinical applications (Auffret et al, 2017;Lim, 2018;Catterall et al, 2020). However, current clinical BHVs suffer from many defects such as poor durability, leaflet damage, and calcium deposition, therefore, it is urgent to enhance these properties of BHVs (Lopez-Moya et al, 2018;Zhang et al, 2018).…”
The bioprosthetic heart valves (BHVs) are the best option for the treatment of valvular heart disease. Glutaraldehyde (Glut) is commonly used as the golden standard reagent for the crosslinking of BHVs. However, the obvious defects of Glut, including residual aldehyde toxicity, degradation and calcification, increase the probability of valve failure in vivo and motivated the exploration of alternatives. Thus, the aim of this study is to develop a non-glutaraldehyde hybrid cross-linking method composed of Neomycin Trisulfate, Polyethylene glycol diglycidyl ether and Tannic acid as a substitute for Glut, which was proven to reduce calcification, degradation, inflammation of the biomaterial. Evaluations of the crosslinked bovine pericardial included histological and ultrastructural characterization, biomechanical performance, biocompatibility and structural stability test, and in vivo anti-inflammation and anti-calcification assay by subcutaneous implantation in juvenile Sprague Dawley rats. The results revealed that the hybrid crosslinked bovine pericardial were superior to Glut crosslinked biomaterial in terms of better hydrophilicity, thermodynamics stability, hemocompatibility and cytocompatibility, higher Young’s Modulus, better stability and resistance to enzymatic hydrolysis, and lower inflammation, degradation and calcification levels in subcutaneous implants. Considering all above performances, it indicates that the hybrid cross-linking method is appropriate to replace Glut as the method for BHV preparation, and particularly this hybrid crosslinked biomaterials may be a promising candidate for next-generation BHVs.
“…However, it is still challenging to maintain a safe and efficient treatment ( 8 ). Major bleeding (which can be life-threatening), intracranial bleeding, and fatal bleeding are observed in 2–5, 0.2–0.4, and 0.5–1.0%, respectively, with patients on warfarin per year ( 9 ). What is more, warfarin therapy is fraught with several inherent problems, such as great diversity in dosing, delayed onset of action along with prolonged effect after discontinuation, a wide range of serious interactions, and a narrow therapeutic index.…”
BackgroundDespite warfarin therapy had been used for decades for patients with mechanical mitral valve prostheses (MMVPs), serious and life-threatening complications are still reported worldwide with a significant economic burden. This study is aimed at assessing the clinical and the cost-effectiveness of adopting pharmacist-managed warfarin therapy (PMWT) services for optimizing warfarin treatment in Egypt.MethodsA prospective randomized trial in which 59 patients with MMVPs were randomly assigned to receive the PMWT services or the standard care and followed up for 1 year. The primary outcome was percentage time in the therapeutic range (TTR). For the cost-effectiveness analysis, a Markov cohort process model with nine mutually exclusive health states was developed from a medical provider’s perspective. A lifetime horizon was applied. All costs and outcomes were discounted at 3.5% annually.ResultsThe study results revealed a significantly higher median TTR in the intervention group as compared to the control group; 96.8% [interquartile range (IQR) 77.9–100%] vs. 73.1% (52.7–95.1%), respectively, p = 0.008. A significant association between standard care and poor anticoagulation control (p = 0.021) was demonstrated by the multivariate regression analysis. For the cost-effectiveness analysis, the total cumulative quality-adjusted life-years (QALYs) and total costs per patient were 21.53 and 10.43; 436.38 and 1,242.25 United States dollar (USD) in the intervention and the control groups, respectively, with an incremental cost-effectiveness ratio (ICER) of −72.5796 for the intervention group.ConclusionThe PMWT strategy was proven to provide a significantly better anticoagulation control and to be a cost-saving approach in Egyptian patients with MMVPs. Nevertheless, the dominance of this strategy is sustained by maintaining the therapeutic International Normalized Ratio (INR) control within the recommended range. Our findings will benefit Egyptian policy-makers who may seek novel health strategies for better resource allocation.Clinical Trial Registration[ClinicalTrials.gov], identifier [NCT04409613].
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