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. 2020 Jun 2;172(11):717-725.
doi: 10.7326/M19-3583. Epub 2020 May 12.

Residual Shunt After Patent Foramen Ovale Closure and Long-Term Stroke Recurrence: A Prospective Cohort Study

Wenjun Deng  1 , Shanye Yin  1 , David McMullin  1 , Ignacio Inglessis-Azuaje  1 , Sammy Elmariah  1 , Judy Hung  1 , Eng H Lo  1 , Igor F Palacios  1 , Ferdinando S Buonanno  1 , MingMing Ning  1
Affiliations

Residual Shunt After Patent Foramen Ovale Closure and Long-Term Stroke Recurrence: A Prospective Cohort Study

Wenjun Deng et al. Ann Intern Med. .

Abstract

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.

Keywords: Aneurysms; Echocardiography; Factor analysis; Hyperlipidemia; Hypertension; Ischemic stroke; Longitudinal studies; Medical risk factors; Stroke; Transient ischemic attacks.

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Conflict of interest statement

Disclosures: Authors have disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M19-3583.

Figures

Figure 1.
Figure 1.
Study flow diagram. PFO = patent foramen ovale; TIA = transient ischemic attack.
Figure 2.
Figure 2.
Cumulative incidence of recurrent stroke or TIA in patients with and without residual shunt after percutaneous PFO closure. HR = hazard ratio; PFO = patent foramen ovale; TIA = transient ischemic attack.
Figure 3.
Figure 3.
Subgroup analysis of recurrent stroke or TIA. HR = hazard ratio; TIA = transient ischemic attack.
See this image and copyright information in PMC

Comment in

References

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