Urgent surgery vs fibrinolytic therapy for left-sided prosthetic valve thrombosis: a randomized trial
Ganesan Karthikeyan, Palleti Rajashekar, Niveditha Devasenapathy, Shyamashree Biswas, Bharath Raj Kidambi, A. K. Singal, Mohsin Raj Mantoo, Manoj Soni, Gaurav Purohit, Milind Hote, Sandeep Singh, Velayoudam Devagourou
Abstract
BACKGROUND AND AIMS: Left-sided mechanical prosthetic valve thrombosis (PVT) is common in low-resource settings. Treatment is either by fibrinolytic therapy (FT) or urgent surgery. This is the first randomized controlled trial (RCT) comparing urgent surgery with FT for symptomatic left-sided PVT. METHODS: This is a single-centre RCT comparing urgent surgery with FT (low-dose, slow-infusion tissue plasminogen activator [t-PA]) in patients with symptomatic left-sided PVT. The primary outcome was complete clinical response, defined as discharge from hospital with completely restored valve function, without major complications. The primary safety outcome was a composite of death, non-fatal stroke, non-fatal major bleed, or systemic embolism, at discharge. Outcomes were assessed by investigators blinded to treatment allocation. RESULTS: Over a 6-year period, 79 patients were randomized to urgent surgery (n = 39) or FT (n = 40). Patients most often had a thrombosed mitral prosthesis (72%) with 43% in New York Heart Association class III/IV. All patients allocated to FT received t-PA. Of the 32 patients who had surgery, 17 (53%) underwent the procedure within 48 h. In the intention-to-treat population, the primary outcome was not significantly different between the two arms (odds ratio [OR] 1.22, 95% confidence interval [CI] 0.46-3.19; P = .689). However, the composite safety outcome occurred more often with surgery (OR 5.14, 95% CI 1.28-20.5; P = .021), driven by the difference in deaths (7/39 vs 1/40; P = .035). Twenty-five percent of patients undergoing FT (10/40) had residual valve dysfunction. CONCLUSIONS: In symptomatic left-sided PVT, urgent surgery is not more efficacious than FT. Surgery is associated with a higher risk of complications, including death, while FT is more often associated with residual valve dysfunction.