Resumen de Trombos en cavidades cardiacas derechas en pacientes con tromboembolia pulmonar aguda sintomática. Pronósito y tratamiento
- español
La evidencia respecto a la prevalencia y al significado pronóstico de la coexistencia de trombos en cavidades cardiacas derechas (TCD) en pacientes con tromboembolia de pulmón (TEP) aguda sintomática es desconocida y el manejo terapéutico de estos pacientes sigue siendo controvertido.
En un primer estudio, en el que se incluyeron 12.441 pacientes con TEP aguda sintomática del Registro Informatizado de la Enfermedad TromboEmbólica (RIETE), observamos que la presencia de TCD es infrecuente y que los pacientes con TEP y TCD tienen peor pronóstico que aquellos pacientes con TEP sin TCD. Realizamos además un metanálisis que incluyó 6 estudios prospectivos y retrospectivos, y observamos que en pacientes diagnosticados de TEP aguda sintomática, la presencia de TCD se asocia a un riesgo aumentado de muerte por cualquier causa y por la propia TEP en los primeros 30 días después del diagnóstico. Un tercer estudio nos permitió demostrar que, en pacientes con TEP y TCD, no hubo diferencias significativas en las tasas de mortalidad y sangrado entre el tratamiento de reperfusión y el tratamiento anticoagulante
- English
Background: Right heart thrombi (RHT), representing clots in-transit, may be detected in <4% of patients with PE,1 and are associated with worse outcomes. Given the limited existing evidence, guidelines do not provide detailed recommendations for management of PE patients with RHT. It is plausible that reperfusion strategies (thrombolytic therapy to help dissolve the RHT and emboli, or percutaneous or surgical thrombectomy to reduce the thromboembolic burden) reduce the adverse outcomes. In turn, such therapies carry risks, including increased bleeding. Using the data from RIETE (Registro Informatizado Enfermedad TromboEmbolica), a prospective international registry of patients with venous thromboembolism, we sought to compare the outcomes of patients with PE and coexisting RHT, with or without reperfusion therapy.
Methods: The design and methodology of RIETE have been previously described. Institutional review board approval and informed consent were obtained at participating sites. We included patients with PE from 0/3/2001-09/2019 and determined the use of reperfusion therapies within 3 days from echocardiographic identification of RHT. The main outcomes were 30-day PErelated mortality (autopsy-confirmed, or death within 10 days from PE, in the absence of an alternative cause), all-cause mortality, major bleeding (events that were overt and required ≥ 2 units of blood, or retroperitoneal, spinal or intracranial, or fatal), and recurrent PE. In the primary analysis, 1:1 propensity score matching was used. We matched each patient receiving reperfusion therapy with the nearest patient not receiving reperfusion, within a caliper width of 0.2-times the standard deviation of the log odds of the propensity score. The score was derived from a group of variables thought to influence the use of reperfusion therapies and outcomes (including vital signs, age, history of heart failure and cancer).
As confirmatory analyses, we included all patients with RHT in multivariable logistic regression, assessing the association between reperfusion therapies and outcomes. Analyses were conducted with Stata Version 16.1. A 2-sided P-value <0.05 was considered significant.
Results: Among 42,620 patients with PE, 443 (1.0%) had RHT, of whom 102 received reperfusion therapy (thrombolytic therapy in 74, percutaneous or surgical thrombectomy in 28). After propensity-score matching, patient characteristics were comparable. During 30-day follow-up, 40 (9.0%) patients died, including 24 (5.4%) from PE. In the propensity-matched cohort (82 pairs), use of reperfusion therapy was not associated with significantly reduced odds of 30-day PE-related mortality (odds ratio [OR]: 0.65, 95% confidence interval [CI]: 0.20-2.16, P=0.48) or allcause mortality (OR: 0.86, 95% CI: 0.30-2.43, P=0.78). The rate of major bleeding was comparable (OR: 1.00, 95% CI: 0.25-3.92, P=0.999). Six patients receiving reperfusion therapy and 0 controls had recurrent PE (risk difference: 0.08, 95% CI: 0.02-0.14). Findings were similar in multivariable logistic regression analyses.
Discussion: In this study, we failed to find a significantly reduced odds of PE-related mortality with reperfusion attempt, mainly through thrombolytic therapy. Despite reporting the largest series of patients with RHT from a multinational registry, type II error is possible, similar to a prior investigation. Considering the hypothesisgenerating increase in recurrent PEs, it might be prudent to avoid routine use of thrombolytic therapy in hemodynamically-stable PE patients with RHT. Nevertheless, these patients have an increased risk of adverse outcomes and alternative strategies, including surgical, or percutaneous thrombectomy require further investigations. Despite reporting the largest patient series with PE and RHT, small numbers made it unfeasible to assess the clinical subgroups. Given the rarity of this condition, it is unlikely that a large trial becomes available. In conclusion, in patients with PE and RHT, use of reperfusion therapy was not associated with significantly lower PE-related mortality. Additional studies are required to identify effective treatments for this high-risk clinical subgroup.
Disclosures: Dr. Bikdeli reports that he is a consulting expert (on behalf of the plaintiff) for litigation related to a specific type of inferior vena cava filters. The current studyis the idea of the investigators and has not been performed at the request of a third party. We express our gratitude to Sanofi Spain for supporting this Registry with an unrestricted educational grant. We also express our gratitude to Bayer Pharma AG for prior support to this Registry. Bayer Pharma AG's support was limited to the part of RIETE outside Spain. The funders had no role in the study design, statistical analyses, or submission of the results for publication.
