TY - JOUR
T1 - Residual shunt after patent foramen ovale closure and long-term stroke recurrence
T2 - A prospective cohort study
AU - Deng, Wenjun
AU - Yin, Shanye
AU - McMullin, David
AU - Inglessis-Azuaje, Ignacio
AU - Elmariah, Sammy
AU - Hung, Judy
AU - Lo, Eng H.
AU - Palacios, Igor F.
AU - Buonanno, Ferdinando S.
AU - Ning, Ming Ming
N1 - Funding Information:
This study was funded by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health (NIH/NINDS grants R01NS067139 and R01NS093415). The funder had no role in the design, conduct, or analysis of the study or in the decision to publish the manuscript.
Publisher Copyright:
© 2020 American College of Physicians
PY - 2020/6/2
Y1 - 2020/6/2
N2 - 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.
AB - 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.
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U2 - 10.7326/M19-3583
DO - 10.7326/M19-3583
M3 - Article
C2 - 32422058
AN - SCOPUS:85085904475
SN - 0003-4819
VL - 172
SP - 717
EP - 725
JO - Annals of internal medicine
JF - Annals of internal medicine
IS - 11
ER -
