Comparison of Sex Based In-Hospital Procedural Outcomes and Hospital Readmission Frequency After Patent Foramen Ovale Occluder Device Placement: A Propensity Matched National Cohort.

INTRODUCTION: PFO occluder device has been shown to reduce the chance of recurrent stroke in clinically indication per guidelines, stroke is higher in females but procedural efficacy and complications based on sex difference is not well studied in literature.

METHODS: The Nationwide Readmission Database (NRD) was used to create sex cohorts using ICD-10 Procedural code for elective PFO occluder device placement performed during the years 2016-2019. The two groups were compared using propensity score matching (PSM) and multivariate regression models that matched for confounders to report multivariate odd's ratio (mOR) for primary and secondary cardiovascular outcomes. Outcomes included in-hospital mortality, acute kidney injury (AKI), acute ischemic stroke, post-procedure bleeding, and cardiac tamponade. Statistical analysis was performed using STATA v. 17.

RESULTS: A total of 5,818 patients who underwent PFO occluder device placement were identified, of which 3,144 (54.0%) were females, and 2,673 (46.0%) were males. There was no difference in periprocedural in-hospital mortality, new onset acute ischemic stroke, post-procedural bleeding, or cardiac tamponade between both sexes undergoing occluder device placement. AKI onset was higher in males as compared to females after matching for CKD (mOR = 0.66; 95% CI [0.48-0.92]; p=0.016) this can be procedural or can be secondary to volume status or nephrotoxins. Males also had a higher length of stay (LOS) at their index hospitalization (2 days vs 1 day) which led to slightly higher total hospitalization cost ($26,585 vs $24,265). Our data did not show a statistically significant difference in the readmission LOS trends between the two groups at 30, 90, and 180 days.

CONCLUSION: PFO occluder is equally efficacious in both sex and no significant difference in sex-based complications noticed on national cohort analysis. AKI occurrence was high in males that can be limited due to unavailability of data about hydration status and nephrotoxic medications.