Abstract
Transcatheter patent foramen ovale (PFO) occluder device is a procedure mostly performed to prevent secondary stroke as a result of paradoxical emboli traversing an intracardiac defect into the systemic circulation. The complications and outcomes following the procedure remain poorly studied. We aimed to investigate morbidity and mortality associated with occluder device procedures using hospital frailty index score stratification. The Nationwide Readmission Database was employed to identify patients admitted for PFO closure from 2016 to 2020. Two groups divided by index frailty score were compared to report adjusted odds ratio (aOR) for primary and secondary cardiovascular outcomes. Outcomes included in-hospital mortality, acute kidney injury, acute ischemic stroke, and post-procedure bleeding. Statistical analysis was performed using STATA v.17. Of the 2,063 total patients who underwent the procedure, 45% possessed intermediate to high frailty scores while the other 55% had low frailty scores. The first cohort had higher odds of in-hospital mortality (aOR 6.3, 95% CI 2.05-19.5), acute kidney injury (aOR 17.6, 95% CI 9.5-32.5), and stroke (aOR 3.05, 95% CI 1.5-5.8) than the second cohort. There was no difference in the incidence of post-procedural bleeding and cardiac tamponade and 30/90/180-day readmission rates between the two cohorts. Hospitalizations in the first cohort were associated with a higher median length of stay and total cost. High to intermediate frailty scores may predict an increased risk of in-hospital mortality in patients undergoing PFO occluder device procedures.
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