Obstructive Thrombus
Conditions
Keywords
Prosthetic valve, Thrombosis, Surgery, Thrombolytic therapy, Transesophageal echocardiography
Brief summary
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
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.
Interventions
DRUGThrombolytic Therapy
Thrombolytic therapy is performed to the patients with obstructive prosthetic valve thrombosis
PROCEDURESurgery
Redo valve surgery is performed for obstructive valve thrombosis
Sponsors
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Obstructive prosthetic valve thrombosis
Exclusion criteria
* Non-obstructive prosthetic valve thrombosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thrombolytic success | Up to 10 days | 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 |
| Non-fatal complications for thrombolytic therapy | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks | Nonfatal major complication: Ischemic stroke, intracranial hemorrhage, embolism (coronary or peripheral), bleeding requiring transfusion. Nonfatal minor complication: Bleeding without need for transfusion, TIA. |
| Successful Surgery | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks; and postoperative 3 months | Successful redo valve surgery in the absence of fatal and non fatal major complications. |
| Complications for surgery | Participants will be followed for the duration of hospital stay an expected average of 3 weeks; and postoperative 3 month | 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 |
| In hospital mortality | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks | All cause in-hospital mortality. |
Countries
Turkey (Türkiye)
Outcome results
None listed