Treatment of prosthetic valve thrombosis: rationale for a prospective randomized clinical trial.

BACKGROUND AND AIM OF THE STUDY: Prosthetic valve thrombosis (PVT) is a serious complication that may cause significant morbidity and mortality. Despite advances in valve technology, patient education and adequate anticoagulation, the risk of PVT persists indefinitely. Certain clinical and prothrombotic states, including atrial fibrillation, insufficient anticoagulation and pregnancy, predispose these patients to develop PVT. The optimal treatment of the condition is controversial, and to date no randomized clinical trials have been conducted to assist in decision making. Consequently, the guidelines lack definitive Class I recommendations, have significant disparities, and--in most cases--leave the decision to the clinician's experience.

METHODS: A review of the studies, guidelines, and expert opinions on the treatment of PVT was conducted, and treatment recommendations made for obstructive and non-obstructive thrombotic cases, based on the results of the recent reports.

RESULTS: Although surgical therapy has been the traditional therapeutic approach, studies with low-dose and slow-infusion rates of thrombolytic agents have revealed excellent results in these patients. Surgery should be considered first in patients with left atrial thrombus, active bleeding, and within the first four days after valve replacement. Patients with nonobstructive PVT can initially be managed with an intensification of anticoagulation.

CONCLUSION: The management of PVT remains controversial. Clearly, a prospective randomized clinical trial is required, and this could be achieved by developing an international database for patient enrollment and randomization into available treatment strategies.