Standardized Mortality Ratio and Long-Term Stroke Incidence After PFO Closure - A Register Study

Sep 30, 2026

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Closure of a patent foramen ovale (PFO) is commonly recommended for patients with cryptogenic stroke, yet long-term real-world outcomes remain unclear. This register study links congenital heart disease and stroke national records to quantify standardized mortality ratio, subsequent stroke events, and associated risk factors after PFO closure between 2001 and 2018, using survival analysis and Cox regression methods.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages10

Reading Time25 min

AccessFree to download

Abstract

Background

Objectives

Methods

Results

Conclusions

Long-Term Follow-Up After PFO Closure

J A C C : A D V A N C E S V O L . 5 , N O . 1 , 2 0 2 6 © 2 0 2 6 T H E A U T H O R S . P U B L I S H E D BY E L S E V I E R O N B E H A L F O F T H E A M E R I C A N C O L L E G E O F C A R D I O L O GY F O U N D A T I O N . T H I S I S A N O P E N A C C E S S A R T I C L E U N D E RT H E C C B Y L I C E N S E ( [h t t p : / / c r e a t i v e c o m m o n s . o r g / l i c e n s e s / b y / 4 . 0 /](h t t p : / / c r e a t i v e c o m m o n s . o r g / l i c e n s e s / b y / 4 . 0 /) ) . ORIGINAL RESEARCH Standardized Mortality Ratio and Long-Term Stroke Incidence After PFO Closure A Register Study Maria Angerbjörn, MD,a Bengt Johansson, MD, PHD,b Elisabeth Hahlin, MD,b Daniel Rinnström, MD, PHD,b Camilla Sandberg, RPT, PHD,c Christina Christersson, MD, PHD,d Peder Sörensson, MD, PHD,e Mikael Dellborg, MD, PHD,f Ulf Thilén, MD, PHD,g Signild Åsberg, MD, PHD,h Johanna Pennlert, MD, PHDa ABSTRACT BACKGROUND Closure of a patent foramen ovale (PFO) is frequently recommended in patients with cryptogenic stroke. Long-term outcomes in real-world settings remain unknown. OBJECTIVES This study analyzed standardized mortality ratio (SMR), subsequent stroke, and associated risk factors after PFO closure. METHODS National registers on congenital heart disease and stroke were cross-linked to identify individuals who underwent PFO closure between 2001 and 2018. The ratio of observed to expected deaths was calculated (SMR) . Data were analyzed using survival analysis and Cox regression. RESULTS A total of 827 patients (60.5% males, median age 47.9 years, IQR: 40.0-55.6 at the time of PFO closure) were included and observed for a median duration of 8.0 years (IQR: 4.8-11.0) . During follow-up, 23 patients died, SMR was 0.65 (95% CI: 0.41-0.98) . A total of 34 ischemic strokes occurred, yielding an incidence rate of 0.51 events per 100 patient-years. Among the 34 patients who experienced a subsequent stroke, 27 were receiving antithrombotic therapy at the time of the event. New-onset atrial fibrillation following PFO closure was associated with an increased risk of subsequent ischemic stroke (HR: 8.2; 95% CI: 2.6-25.8), as was active/previous smoking (HR: 2.5; 95% CI: 1.2-5.1) . CONCLUSIONS Patients undergoing PFO closure demonstrated a lower all-cause mortality compared to the general population. The observed rate of subsequent ischemic stroke was consistent with findings from previous randomized controlled trials. New-onset atrial fibrillation following PFO closure and active/previous smoking emerged as modifiable risk factors. (JACC Adv. 2026;5:102469) © 2026 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY license ([http://creativecommons.org/licenses/](http://creativecommons.org/licenses/)[ ](http://creativecommons.org/licenses/)[by/4.0/](by/4.0/)) . From the aDepartment of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden; bDepartment of Diagnostics and Intervention Sciences, Umeå University, Umeå, Sweden; cDepartment of Community Medicine and Rehabilitation, Umeå University, Umeå, Sweden; dDepartment of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden; eDepartment of Medicine Solna, Karolinska Institute Stockholm, Solna, Sweden; fDepartment of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; gDepartment of Cardiology, Clinical Sciences, Skane University Hospital, Malmö, Sweden; and the hDepartment of Medical Sciences, Uppsala University, Uppsala, Sweden. The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the Author Center. Manuscript received July 8, 2025; revised manuscript received September 23, 2025, accepted No

FAQs

What was the study designed to evaluate after PFO closure?

The study assessed standardized mortality ratio, subsequent stroke outcomes, and associated risk factors after PFO closure in a real-world setting.

How were participants identified and analyzed?

Individuals who underwent PFO closure between 2001 and 2018 were identified by cross-linking national registers for congenital heart disease and stroke. Observed deaths versus expected deaths were used to compute SMR, with survival analysis and Cox regression for risk assessment.

Which factors were associated with an increased risk of subsequent ischemic stroke?

New-onset atrial fibrillation after PFO closure and active/previous smoking were associated with higher risk of subsequent ischemic stroke.

Sep 30, 2026

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