Recommendation for Mechanical Prosthetic Valve Thrombosis Intervention

CORLOERecommendationComment/Rationale
IB-NRUrgent initial treatment with either slow-infusion low-dose fibrinolytic therapy or emergency surgery is recommended for patients with a thrombosed left-sided mechanical prosthetic heart valve presenting with symptoms of valve obstruction (224–231).MODIFIED: LOE updated to B-NR. Multiple recommendations based only on NYHA class symptoms were combined into 1 recommendation. Slow-infusion fibrinolytic therapy has higher success rates and lower complication rates than prior high-dose regimens and is effective in patients previously thought to require urgent surgical intervention. The decision for emergency surgery versus fibrinolytic therapy should be based on multiple factors, including the availability of surgical expertise and the clinical experience with both treatments.
See Online Data Supplement 7 and 7A.
Mechanical left-sided prosthetic valve obstruction is a serious complication with high mortality and morbidity and requires urgent therapy with either fibrinolytic therapy or surgical intervention. There has not been an RCT comparing the 2 interventions, and the literature consists of multiple case reports, single-center studies, multicenter studies, registry reports, and meta-analyses—with all the inherent problems of differing definitions of initial diagnosis, fibrinolytic regimens, and surgical expertise (224–235) (Data Supplement 7A). The overall 30-day mortality rate with surgery is 10% to 15%, with a lower mortality rate of <5% in patients with NYHA class I/II symptoms (225,226,232–234). The results of fibrinolytic therapy before 2013 showed an overall 30-day mortality rate of 7% and hemodynamic success rate of 75% but a thromboembolism rate of 13% and major bleeding rate of 6% (intracerebral hemorrhage, 3%) (224–230). However, recent reports using an echocardiogram-guided slow-infusion low-dose fibrinolytic protocol have shown success rates >90%, with embolic event rates <2% and major bleeding rates <2% (231,235). This fibrinolytic therapy regimen can be successful even in patients with advanced NYHA class and larger-sized thrombi. On the basis of these findings, the writing group recommends urgent initial therapy for prosthetic mechanical valve thrombosis resulting in symptomatic obstruction, but the decision for surgery versus fibrinolysis is dependent on individual patient characteristics that would support the recommendation of one treatment over the other, as shown in Table 4, as well as the experience and capabilities of the institution. All factors must be taken into consideration in a decision about therapy, and the decision-making process shared between the caregiver and patient. Final definitive plans should be based on the initial response to therapy.