Redefining treatment paradigms for patients with acute pulmonary embolism and patent foramen ovale

Abstract Background In patients with acute pulmonary embolism (PE), elevated right atrial pressure heightens the risk for right-to-left shunt in the presence of patent foramen ovale (PFO), potentially leading to paradoxical embolism and intracranial bleeding. Purpose Little is known about recent temporal trends in treatment and clinical outcomes of PE patients and concomitant PFO. Methods We analysed data on patient characteristics, treatments and in-hospital outcomes for all PE patients (ICD-code I26) with concomitant presence of PFO in Germany 2005-2021 (source: Research Data Center (RDC) of the Federal Statistical Office and the Statistical Offices of the federal states, DRG Statistics 2005-2021, and own calculations). Results Between January 2005 and December 2021, 1,489,124 patients with acute PE (51.5% females) were included in this analysis; of those, 7,225 (0.5%) had a concomitant diagnosis of PFO. Trends analysis demonstrating an increasing frequency of PE with PFO from 2005 (n=299) to 2021 (n=730; p < 0.001). Patients with PE and PFO were younger (65 vs. 72; P < 0.001) and deceased less often compared to patients without PFO (10.6% vs. 15.2%; P < 0.001). However, patients with PE and PFO presented more often with signs of RV dysfunction (36.2% vs. 27.2%; P < 0.001) or shock (7.5% vs. 3.9%; P < 0.001) as well as paradox arterial emboli (50.2% vs. 3.5%; P < 0.001) and intracerebral bleeding (3.5% vs. 0.6%; P < 0.001). Reperfusion treatments, such as systemic or catheter-directed thrombolysis and surgical or catheter-based thrombectomy, were more frequently employed in patients with acute PE and PFO compared to those without PFO (20.5% vs. 4.7%; p<0.001). Trend analysis revealed that catheter-based thrombectomy showed the most significant increase in usage (ß 3.90 95%CI 3.34-4.46; p<0.001) over the past four years (Figure 1a). In not-high risk patients, no benefit regarding case-fatality was observed comparing conventional treatment with any kind of reperfusion treatment (8.9% vs. 9.7; p=0.356). In high-risk patients, case-fatality rate was higher in patients treated conventional in comparison to any reperfusion strategy (84.6% vs. 47.2%; p<0.001). Between thrombolytic (systemic or catheter-directed) or thrombolytic-free (surgical or catheter-based thrombectomy) treatment no significant difference in mortality was observed (50.0% vs. 41.8%; p=0.186). However, a higher rate of intracranial bleeding was recorded for patients received thrombolytic treatment opposed to patients with reperfusion via thrombectomy (8.9% vs. 4.4%; p<0.001) (Figure 1b). Conclusion Patients with acute PE and concomitant PFO face a heightened risk of paradoxical arterial embolism and intracranial bleeding. In recent years, treatment strategies have evolved, with an increased emphasis on catheter-based thrombectomy. For high-risk PE cases, reperfusion treatment should be considered, despite the frequent occurrence of bleeding complications. .