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Presentation Details
Optimizing Anticoagulation in Pregnant Women with Prosthetic Heart Valves: A Prospective Comparative Study from a Pharmacist-Led Clinic in Pakistan

GUL SAMA1, 2, Ali Hamza1.

1ยน Department of Healthcare Management, Faculty of Business Management Sciences, Concordia University Chicago, Chicago, Illinois, USA, Chicago, IL, USA.2National Institute of Cardivascular Diseases, KARACHI, Pakistan.3Department of pharmaceutical sciences, Faculty of Pharmacy Institute of Pharmaceutical sciences, Jinnah Sindh Medical university, Karachi, KARACHI, Pakistan

Abstract


Background: Pregnancy in women with mechanical prosthetic heart valves presents a unique clinical challenge due to physiological hypercoagulability and the need for lifelong anticoagulation. These patients are at high risk for thromboembolic complications such as valve thrombosis and systemic embolism. However, anticoagulation therapy-particularly with warfarin-carries significant fetal risks, including teratogenicity and hemorrhage. Low-molecular-weight heparin (LMWH) and unfractionated heparin (UFH) are alternative therapies, but optimal management during pregnancy remains controversial, especially in low-resource settings. Objectives: To compare the safety and efficacy of warfarin, LMWH, and UFH in pregnant women with mechanical heart valves. Secondary objectives include assessing maternal and fetal outcomes, identifying therapy-related risks, and evaluating the clinical role of a pharmacist-led anticoagulation clinic. Methods: This prospective cohort study was conducted at the National Institute of Cardiovascular Diseases (NICVD), Karachi. Pregnant women (ages 18-45) with confirmed mitral or aortic mechanical valve replacements and singleton pregnancies were enrolled. Participants were assigned to one of three anticoagulation groups based on clinical decision-making: (1) warfarin, (2) LMWH (e.g., enoxaparin), or (3) UFH. Patients were monitored throughout pregnancy with dose adjustments based on INR (warfarin), anti-Xa (LMWH), or aPTT (UFH). Data collected included demographic characteristics, comorbidities, valve type, coagulation parameters, and pregnancy outcomes. Statistical analysis included chi-square and ANOVA tests for group comparison, and multivariate regression to control for confounding factors. Results: Preliminary findings from ongoing data analysis suggest that warfarin, while effective in preventing thromboembolism, is associated with increased risk of fetal complications, including miscarriage and congenital anomalies. LMWH shows better maternal-fetal safety when guided by anti-Xa levels, though availability and cost are barriers. UFH, requiring hospitalization and frequent monitoring, was used in high-risk patients or during peri-delivery periods. Across all groups, pharmacist-led monitoring significantly reduced dosage errors, maintained therapeutic ranges, and improved maternal adherence. Thromboembolic events were lowest in the LMWH group (preliminary rate <5%), while fetal loss was more common in warfarin users (preliminary rate ~15%). Conclusions: This study highlights the critical need for individualized anticoagulation regimens during pregnancy in women with prosthetic heart valves. LMWH emerges as a safer alternative to warfarin, particularly in the first trimester, and pharmacist-led anticoagulation clinics enhance patient monitoring and outcomes. Our findings underscore the importance of evidence-based protocols tailored to resource-limited settings and aim to inform future clinical guidelines to reduce maternal and fetal morbidity and mortality.

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