Thrombolytic Therapy Versus Surgery for Obstructive Prosthetic Valve Thrombosis

Study Overview
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Brief Summary
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Prosthetic heart valve thrombosis is a serious complication with high mortality and morbidity The best treatment of PVT is controversial, although surgery and thrombolysis options have been available. In this randomized and multicenter study, the investigators compared thrombolytic therapy versus surgery for the treatment of patients with obstructive prosthetic valve thrombosis.

Detailed Description
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Two different randomization group have been defined and patients with obstructive prosthetic valve thrombosis are included in each group randomly. In the first arm, thrombolytic therapy (TT) is performed to the patients with obstructive prosthetic valve thrombosis. The TT regimen depends on the functional status of the patient. In patients with NYHA class III-IV dyspnea low dose, relatively faster TT regimen (25 mg tPA/6 hours) is performed. In patients with NYHA class I-II dyspnea TT with low dose and ultra slow infusion of tPA (25 mg tPA/25 hours) is performed. During TT, patients are followed up with transesophageal echocardiography in every 24 hours. In the second arm, redo valve surgery is performed for obstructive valve thrombosis. This multicenter study is conducted in Cardiology and Cardiovascular Surgery Departments of Kosuyolu Kartal Heart Training and Research Hospital, Istanbul, Turkey, Siyami Ersek Heart Training and Research Hospital, Istanbul, Turkey, Ankara Heart Training and Research Hospital, Ankara, Turkey, İzmir Atatürk Heart Training and Research Hospital, İzmir, Turkey, Erzurum Atatürk University Faculty of Medicine, Erzurum, Turkey, Diyarbakır Dicle University Faculty of Medicine, Diyarbakır, Turkey and Kars Kafkas University Faculty of Medicine, Kars, Turkey. Informed consent is taken from all patients.

Official Title
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Thrombolytic Therapy Versus Surgery for Obstructive Prosthetic Valve Thrombosis: A Randomized Multicenter Study

Conditions
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Obstructive Thrombus

Intervention / Treatment
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* Drug: Thrombolytic Therapy
* Procedure: Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obstructive prosthetic valve thrombosis Exclusion Criteria: Non-obstructive prosthetic valve thrombosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Thrombolytic therapy<br>In the first arm, thrombolytic therapy (TT) is performed to the patients with obstructive prosthetic valve thrombosis. The TT regimen depends on the functional status of the patient. In patients with NYHA class III-IV dyspnea low dose, relatively faster TT regimen (25 mg tPA/6 hours) is performed. In patients with NYHA class I-II dyspnea TT with low dose and ultra-slow infusion of tPA (25 mg tPA/25 hours) is performed. During TT, patients are followed up with transesophageal echocardiography in every 24 hours. | Drug: Thrombolytic Therapy<br>* Thrombolytic therapy is performed to the patients with obstructive prosthetic valve thrombosis<br>|
| Active Comparator: Surgery<br>In the second arm, redo valve surgery is performed for obstructive valve thrombosis. Intraoperative and postoperative results are recorded | Procedure: Surgery<br>* Redo valve surgery is performed for obstructive valve thrombosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombolytic success | In the absence of fatal or nonfatal major complications; Obstructive thrombus: Doppler documentation of the resolution of increased gradient and decreased valve area. Clinical improvement in symptoms. Reduction by ≥75% in major diameter or area of the thrombus. Complete success was defined when all 3 criteria were met and partial success was defined as less than 3 Nonobstrucive thrombus: Complete success: ≥75% reduction in thrombus area. Partial success: 50%-75% reduction in thrombus area | Up to 10 days | 
| Non-fatal complications for thrombolytic therapy | Nonfatal major complication: Ischemic stroke, intracranial hemorrhage, embolism (coronary or peripheral), bleeding requiring transfusion. Nonfatal minor complication: Bleeding without need for transfusion, TIA. | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks | 
| Successful Surgery | Successful redo valve surgery in the absence of fatal and non fatal major complications. | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks; and postoperative 3 months | 
| Complications for surgery | Non fatal major complications: Ischemic stroke, intracranial hemorrhage, embolism (coronary or peripheral), bleeding requiring transfusion, pericardial tamponade, sepsis, pacemaker requirement, mediastinitis, wound infections, acute renal failure Minor complications: bleeding requiring transfusion, plevral effusion, pericardial effusion without tamponade | Participants will be followed for the duration of hospital stay an expected average of 3 weeks; and postoperative 3 month | 
| In hospital mortality | All cause in-hospital mortality. | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prosthetic valve, Thrombosis, Surgery, Thrombolytic therapy, Transesophageal echocardiography