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Updated: Aug 8, 2025
Closure of a Patent Foramen Ovale PFO: An Intervention Sequence
Published on: December 23, 2022
Comparison of Sex-Based In-Hospital Procedural Outcomes and Hospital Readmission Frequency After Patent Foramen Ovale
Sadaf Fakhra1, Yasar Sattar2, Neel N Patel3
1Department of Medicine, University of Nevada, Las Vegas-Kirk Kerkorian School of Medicine, Las Vegas NV.
Insights
This study found that patent foramen ovale (PFO) occluder device placement has similar efficacy and complication rates between males and females. However, males experienced a higher incidence of acute kidney injury (AKI) post-procedure.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Nephrology
Background:
- Patent foramen ovale (PFO) closure reduces recurrent stroke risk, with stroke incidence higher in females.
- Sex-based differences in PFO occluder procedural efficacy and complications remain understudied.
Purpose of the Study:
- To compare cardiovascular outcomes and complications between sexes following elective PFO occluder device placement.
- To identify potential sex-based disparities in procedural success and adverse events.
Main Methods:
- Retrospective analysis of the Nationwide Readmission Database (NRD) from 2016-2019.
- Creation of sex cohorts for elective PFO occluder placement.
- Propensity score matching (PSM) and multivariate regression to compare outcomes, adjusting for confounders.
Main Results:
- No significant sex differences in in-hospital mortality, acute ischemic stroke, bleeding, or cardiac tamponade.
- Higher incidence of acute kidney injury (AKI) observed in males (mOR=0.66; P=0.016) post-procedure.
- Males had a longer length of stay and higher hospitalization costs, but no significant differences in readmission trends.
Conclusions:
- PFO occluder device placement demonstrates comparable efficacy and safety between sexes.
- Males exhibit a higher risk of post-procedural AKI, warranting further investigation into contributing factors.
- The study highlights the need for sex-specific considerations in PFO closure management.
Abstract:
Patent foramen ovale (PFO) occluder device has been shown to reduce the chance of recurrent stroke. Per guidelines, stroke is higher in females but procedural efficacy and complications based on sex difference is understudied. 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 2 groups were compared using propensity score matching (PSM) and multivariate regression models that matched for confounders to report multivariate odds ratio (mOR) for primary and secondary cardiovascular outcomes. Outcomes included in-hospital mortality, acute kidney injury (AKI), acute ischemic stroke, postprocedure bleeding, and cardiac tamponade. Statistical analysis was performed using STATA v. 17. A total of 5818 patients who underwent PFO occluder device placement were identified, of which 3144 (54.0%) were females, and 2673 (46.0%) were males. There was no difference in periprocedural in-hospital mortality, new onset acute ischemic stroke, postprocedural bleeding, or cardiac tamponade between both sexes undergoing occluder device placement. AKI incidence was higher in males 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 2 groups at 30, 90, and 180 days. This national retrospective cohort study of PFO occluder outcomes shows similar efficacy and complication rates between sexes, with the exception of AKI incidence which was higher in males. AKI occurrence was high in males that can be limited due to unavailability of data about hydration status and nephrotoxic medications.
