The presence of residual shunt after PFO closure was associated with an increased incidence of recurrent stroke or TIA compared with complete closure (HR 3.05; 95% CI 1.65-5.62; P<0.001).
Cohort (n=1,078)
No
Does the presence of residual shunt after PFO closure increase the risk of recurrent stroke or TIA in patients with PFO-attributable cryptogenic stroke?
The presence of a residual shunt, particularly a moderate or large one, after PFO closure is associated with a significantly increased long-term risk of recurrent stroke or TIA.
Estimación del efecto: HR 3.05 (95% CI 1.65 to 5.62)
Tasa de eventos absoluta: 2.32% vs 0.75%
valor p: p=< 0.001
Background: Residual shunt is observed in up to 25% of patients after patent foramen ovale (PFO) closure, but its long-term influence on stroke recurrence currently is unknown. Objective: To investigate the association of residual shunt after PFO closure with the incidence of recurrent stroke and transient ischemic attack (TIA). Design: Prospective cohort study comparing stroke or TIA recurrence in patients with and without residual shunt after PFO closure. Setting: Single hospital center. Participants: 1078 consecutive patients (mean age, 49.3 years) with PFO-attributable cryptogenic stroke who were undergoing percutaneous PFO closure were followed for up to 11 years. Measurements: Residual shunt was evaluated by transthoracic echocardiography with saline contrast. Primary outcome was a composite of the first recurrent ischemic stroke or TIA after PFO closure. Results: Compared with complete closure, the presence of residual shunt after PFO closure was associated with an increased incidence of recurrent stroke or TIA: 2.32 versus 0.75 events per 100 patient-years (hazard ratio HR, 3.05 95% CI, 1.65 to 5.62; P < 0.001). This result remained robust after adjustment for important covariates, namely age; study period; device; presence of atrial septal aneurysm, hypertension, hyperlipidemia, diabetes, hypercoagulability, or hypermobile septum; and medication use (HR, 3.01 CI, 1.59 to 5.69; P < 0.001). Further stratification based on shunt size revealed that moderate or large residual shunts were associated with a higher risk for stroke or TIA recurrence (HR, 4.50 CI, 2.20 to 9.20; P < 0.001); the result for small residual shunts was indeterminate (HR, 2.02 CI, 0.87 to 4.69; P = 0.102). Limitation: Nonrandomized study with potential unmeasured confounding. Conclusion: Among patients undergoing PFO closure to prevent future stroke, the presence of residual shunt, particularly a moderate or large residual shunt, was associated with an increased risk for stroke or TIA recurrence. Primary Funding Source: National Institutes of Health.
Deng et al. (Sun,) conducted a cohort in PFO-attributable cryptogenic stroke (n=1,078). Residual shunt vs. Complete closure was evaluated on Composite of the first recurrent ischemic stroke or TIA after PFO closure (HR 3.05, 95% CI 1.65 to 5.62, p=< 0.001). The presence of residual shunt after PFO closure was associated with an increased incidence of recurrent stroke or TIA compared with complete closure (HR 3.05; 95% CI 1.65-5.62; P<0.001).