Thrombolysis or Surgery in Patients With Obstructive Mechanical Valve Thrombosis
Key result
Low-dose t-PA is linked to ~87% lower 3-month mortality and fewer major complications versus surgery.
- n=158
Why the study?
Due to a lack of randomized controlled trials, the optimal first-line treatment for obstructive prosthetic valve thrombosis remains controversial between thrombolytic therapy and surgery.
Does thrombolytic therapy reduce mortality and complications compared to surgery in patients with obstructive mechanical valve thrombosis?
Population
158 patients with obstructive PVT
Comparison
Thrombolytic therapy vs surgery as first-line strategy
Design
Multicenter observational prospective study
Follow-up
3 months
Authors
Discussion
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Member takes
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
HVHartzell V. SchaffCardiovascular surgeon, Mayo Clinic
“Reoperation for valve thrombectomy or replacement will be necessary for patients with cardiogenic shock, patients with associated pannus underlying thrombus formation, as well as patients with contraindications to thrombolysis including left atrial clot.”
“unique in this field”
“Surgery has a high mortality rate even in experienced centers; therefore, thrombolytic therapy may be considered as a beneficial treatment strategy in patients with obstructive prosthetic valve thrombosis in the absence of contraindications”
Implication
TT associated with lower mortality than surgery in obstructive PVT; challenges surgical-first guidelines and leaves open need for RCTs.
Key Points
- This study aims to compare thrombolytic therapy and surgery as first-line treatments for obstructive prosthetic valve thrombosis.
- 158 obstructive PVT patients enrolled in a multicenter prospective study
- Thrombolytic therapy involved slow and ultraslow infusion of low-dose tissue plasminogen activator (t-PA)
- 3-month mortality was the primary endpoint evaluated.
- Thrombolytic therapy was the initial management in 83 patients (52.5%) with a success rate of 90.4%
- 3-month mortality was 14 patients (18.7%) for surgery versus 2 patients (2.4%) for thrombolytic therapy
- Minor and major complications were higher in the surgery group (38.7% and 41.3%) compared to t-PA (8.4% and 6%).
Study Design
Type
Observational (n=158)
Multicenter
Yes
Structured PICO
Does thrombolytic therapy reduce mortality and complications compared to surgery in patients with obstructive mechanical valve thrombosis?
P
Population
158 patients (65.2% female, median age 49) with obstructive prosthetic valve thrombosis prospectively evaluated for 3-month mortality following thrombolytic therapy versus surgery.
E
Exposure
Thrombolytic therapy (TT) using slow (6 hours) and/or ultraslow (25 hours) infusion of low-dose tissue plasminogen activator (t-PA) (25 mg), mostly in repeated sessions.
C
Comparator
Surgery.
O
Outcome
3-month mortality following TT or surgery.hard clinical
Main Result
Absolute Event Rate: 2.4% vs 18.7%
Low-dose, slow/ultraslow infusion of t-PA is associated with lower mortality and fewer complications compared to surgery for obstructive prosthetic valve thrombosis.
Cite This Study
Özkan et al. (2022) conducted an observational in Obstructive prosthetic valve thrombosis (n=158). Thrombolytic therapy (low-dose t-PA) vs. Surgery was evaluated on 3-month mortality. Thrombolytic therapy with low-dose t-PA was associated with lower 3-month mortality (2.4% vs 18.7%) and fewer major complications (6.0% vs 41.3%) compared to surgery.