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Thrombolysis or Surgery for Mechanical Valve Thrombosis
Quick Takes
- This large, multicenter, prospective, observational study of slow-infusion, low-dose thrombolytic therapy (TT) versus surgery for the treatment of patients with mechanical PHV found a success rate of 90.4% for TT with a median tPA dose of 59 mg (IQR 37.5-100 mg).
- The 3-month mortality rate was 2.4% for the TT group and 18.7% for the surgery group. The major complication rate was 6% in the TT group and 41.3% in the surgery group.
Study Questions:
What are the respective outcomes of thrombolytic therapy (TT) and surgery as the first-line treatment strategy among patients with obstructive prosthetic valve thrombosis (PVT)?
Methods:
A total of 158 adult patients (103 [65.2%] women, median age 49 years [IQR 39-60 years]) with obstructive prosthetic heart valve (PHV) were enrolled in an observational, prospective, multicenter study between December 2013–December 2020 at eight tertiary care centers in Turkey. Exclusion criteria included a contraindication to TT, nonobstructive PVT, presence of obstructive pannus, end-stage liver disorder, prosthetic valve endocarditis, left atrial thrombus, pregnancy, cardiogenic shock, and malignancy. TT was performed using slow (6 hours) and/or ultraslow (25 hours) infusion of low-dose tissue plasminogen activator (tPA; 25 mg) mostly in repeated sessions. The primary endpoint of the study was 3-month mortality following TT or surgery. A secondary endpoint was all major complications occurring within 3 months of therapy, including new persistent left ventricular dysfunction, major bleeding, ischemic or hemorrhagic stroke, endocarditis, tamponade requiring surgery, sepsis, mediastinitis, acute kidney injury requiring renal replacement therapy, catastrophic cardiac injury, prolonged endotracheal intubation requiring tracheostomy, coronary or peripheral embolism, and severe paravalvular leak. Minor complications were pneumonia, sternitis, wound infection, minor bleeding, transient ischemic attack, postprocedural arrhythmias, left atrial thrombus, pleural effusion requiring drainage, and moderate paravalvular leak.
Results:
The initial management strategy was TT in 83 (52.5%) patients (72.3% women) and surgery in 75 (47.5%) patients (57.3% women). The respective location of the thrombosed valve in the TT group and in the surgery group were mitral in 55 (66%) and 64 (85%), aortic in 19 (23%) and 7 (9%), and tricuspid in 9 (11%) and 4 (5%). The median thrombus area on 2D echocardiography was 1.1 (IQR 0.9-1.3) cm in the TT group and 1.1 (IQR 0.9-1.4) cm in the surgery group. The success rate of TT was 90.4% with a median tPA dose of 59 mg (IQR 37.5-100 mg). The 3-month mortality was 2 of 83 (2.4%) for the TT group and 14 of 75 (18.7%) for the surgery group. Major complication rates in the TT and surgery groups were 5 (6%) and 31 (41.3%), respectively; and minor complication rates were 7 (8.4%) and 29 (38.7%), respectively.
Conclusions:
Low-dose and slow/ultraslow infusion of tPA were associated with low complications and mortality and high success rates. The authors concluded that TT should be considered as a viable treatment in patients with obstructive PVT.
Perspective:
Symptomatic PVT requires urgent treatment, with options of surgery or slow-infusion low-dose TT. Current American College of Cardiology/American Heart Association valvular heart disease guidelines recommend either treatment strategy (Class I) after consideration of factors including available surgical expertise, surgical risk, functional class, and clot size (>0.8 cm2 vs. ≤0.8 cm2); whereas current European Society of Cardiology guidelines favor treatment with surgery (Class I) over TT (Class IIa). This large, prospective, observational study suggests that TT was associated with favorable 3-month outcomes. As an observational study, groups were uneven at least in terms of valve location and patient sex, and the study does not provide statistical comparisons between group characteristics or group outcomes. Surgical expertise is difficult to quantify, and the ability to extrapolate the results to all centers therefore may be limited. However, the study provides additional data to support the role of slow-infusion, low-dose TT in the treatment of patients with symptomatic mechanical PHV.
Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Dyslipidemia, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Vascular Medicine, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Lipid Metabolism, Acute Heart Failure, Interventions and Imaging, Interventions and Structural Heart Disease, Interventions and Vascular Medicine, Echocardiography/Ultrasound
Keywords: Acute Kidney Injury, Arrhythmias, Cardiac, Cardiac Surgical Procedures, Diagnostic Imaging, Echocardiography, Embolism, Endocarditis, Heart Failure, Heart Valve Diseases, Heart Valve Prosthesis, Hemorrhage, Hemorrhagic Stroke, Ischemic Attack, Transient, Mediastinitis, Pleural Effusion, Pneumonia, Renal Replacement Therapy, Sepsis, Stroke, Thrombolytic Therapy, Thrombosis, Tissue Plasminogen Activator, Ventricular Dysfunction, Left
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