Abstract 17667: Thrombolysis versus Surgery for Obstructive Prosthetic Valve Thrombosis
Introduction: Surgery is recommended over thrombolysis for most patients (pts) with obstructive prosthetic valve thrombosis (OPVT) in current guidelines. Recently, increasing evidences are available regarding the safety and efficacy of thrombolytic therapy (TT) for OPVT.
Hypothesis: We assessed the hypothesis that low-dose slow infusion recombinant tissue plasminogen activator (t-PA) may be as effective and safe as surgery in OPVT.
Methods: In this observational multicenter (8 centers) study, overall 66 pts (43 female, age 47±14 years) with OPVT assessed by transesophageal echocardiography (TEE) and without a contraindication to TT or surgery were prospectively included between December 2013 and May 2016. Pts were assigned to either TT (n=33) or surgery (n=33). The TT regimen included an initial slow (6-hour) infusion of low dose (25 mg) t-PA in those with New York Heart Association (NYHA) Class-IV with repetition until the pt was stabilized, followed by an ultra-slow (25-hours) infusion of the same dose with repetition until complete success or up to 200 mg, whichever achieved earlier. The ultra-slow TT regimen was implemented as the initial approach in those with NYHA Class I to III. Pts were followed up clinically during the in-hospital period and also assessed clinically and by TEE at 2-months post-discharge. Primary outcome was in-hospital success rate defined as freedom from PVT without major complications (death, embolism, bleeding). Secondary outcomes were major adverse cardiovascular events (MACE, a composite of death, thromboembolism, rehospitalization) and death at 2 months.
Results: No differences were observed between the groups in terms of baseline clinical and TEE characteristics including age, gender, heart rhythm, NYHA Class, elapsed time since valve surgery, PVT location, thrombus area, valve area, history of stroke or previous PVT (p>0.05 for all). The primary outcome was similar between the TT and surgery groups (90.6 vs 93.5%, respectively, p=1) . A lower MACE (18.8 vs 42.9%, p=0.04) and a numerically lower [1 (3%) vs 3 (9.1%)] death at 2-months were observed in the TT Group.
Conclusion: The efficacy of low-dose and slow infusion of t-PA in pts with OPVT is similar to surgery. Moreover, it is in favour of t-PA in terms of MACE and death.
Author Disclosures: S. Gündüz: None. M. Yesin: None. M. Kalçik: None. E. Bayam: None. S. Cersit: None. M.O. Gürsoy: None. S. Karakoyun: None. Ö. Yildirimtürk: None. T. Kemaloglu Öz: None. H. Kaya: None. M.A. Astarcioglu: None. B. Demirkan: None. Y. Güray: None. &.H. Tanboga: None. C. Nazli: None. K. Tigen: None. M. Özkan: None.
- © 2016 by American Heart Association, Inc.