The clinical challenge of bridging anticoagulation with low-molecular-weight heparin in patients with mechanical prosthetic heart valves: An evidence-based comparative review focusing on anticoagulation options in pregnant and nonpregnant patients

BACKGROUND: Recent labeling changes for enoxaparin, a low-molecular-weight heparin (LMWH), have prompted a reexamination of its role in patients with mechanical prosthetic heart valves (MPHVs). Healthcare providers are faced with the challenge of weighing favorable trial results with LMWHs and balancing their clinical experiences with these agents as a bridge to oral anticoagulation in patients with prosthetic heart valves. This review will provide evidence-based guidance on issues surrounding the use of LMWH that require bridging anticoagulant therapy in the setting of cardiac surgery (MPHVs), cardiovascular disease, and during temporary interruption of oral anticoagulants in patients requiring periprocedural bridging therapy. METHODS: A Medline search was conducted of articles appearing in the medical literature published in English between 1992 and 2004. Approximately 120 clinical trials, case reports, editorials, and/or guideline statements were retrieved and reviewed by the authors as to their relevance for the subject under review, ie, bridging anticoagulation in patients with MPHVs. Approximately 80 of these publications were selected for detailed review, analysis, and discussion in a consensus format. RESULTS: This review addresses the controversy surrounding the divergence between the new labeling recommending against the use of LMWH in patients with MPHVs as well as the ongoing clinical experience and evidence in the medical literature. The clinical challenges in the use of LMWH and unfractioned heparin (UFH) in pregnant patients with MPHVs are presented; the evidence for LMWHs in nonpregnant patients with prosthetic valves is described; and the role of LMWH for bridging immediately after mechanical valve surgery and its periprocedural and perioperative uses are discussed. Based on an expert consensus panel, clinical algorithms for the use of LMWH in pregnant and nonpregnant patients with MPHVs are also illustrated. CONCLUSIONS: Based on the available data sets, clinical trials, reviews, and registry data, the evidence suggests that LMWH compared to UFH may be a safe and effective agent in patients with MPHVs. Future large-scale, randomized trials are warranted.