ABSTRACT
AIMS: Transcatheter closure of patent foramen ovale (PFO) is the recommended stroke prevention treatment in patients ≤60 years with cryptogenic ischemic stroke and PFO. Atrial fibrillation or flutter (AF) is a known potential procedure-related complication, but long-term risk of developing AF remains unknown. This paper studied the long-term risk of developing AF following PFO closure. METHODS AND RESULTS: A Danish nationwide cohort study was conducted. During 2008-2020, this study identified a PFO closure cohort, a PFO diagnosis cohort without PFO closure, and a general population comparison cohort matched 10:1 to the PFO closure cohort on age and sex. The outcome was first-time AF diagnosis. Risk of AF and multivariable-adjusted hazard ratio (HR) of the association between PFO closure or PFO diagnosis and AF were calculated. A total of 817 patients with PFO closure, 1224 with PFO diagnosis, and 8170 matched individuals were identified. The 5 year risk of AF was 7.8% [95% confidence interval (CI): 5.5-10] in the PFO closure cohort, 3.1% (95% CI: 2.0-4.2) in the PFO diagnosis cohort, and 1.2% (95% CI: 0.8-1.6) in the matched cohort. The HR of AF comparing PFO closure with PFO diagnosis was 2.3 (95% CI: 1.3-4.0) within the first 3 months and 0.7 (95% CI: 0.3-1.7) thereafter. The HR of AF comparing PFO closure with the matched cohort was 51 (95% CI: 21-125) within the first 3 months and 2.5 (95% CI: 1.2-5.0) thereafter. CONCLUSION: Patent foramen ovale closure was not associated with any substantial increased long-term risk of developing AF beyond the well-known procedure-related short-term risk.
Subject(s)
Atrial Fibrillation , Foramen Ovale, Patent , Septal Occluder Device , Stroke , Humans , Atrial Fibrillation/etiology , Atrial Fibrillation/complications , Stroke/epidemiology , Stroke/etiology , Stroke/diagnosis , Foramen Ovale, Patent/complications , Foramen Ovale, Patent/epidemiology , Foramen Ovale, Patent/diagnosis , Cohort Studies , Secondary Prevention/methods , Cardiac Catheterization/adverse effects , Denmark/epidemiology , Treatment Outcome , Recurrence , Septal Occluder Device/adverse effectsABSTRACT
AIM: Living with a stoma can greatly influence quality of life. The purpose of this systematic review was to identify all patient reported outcome measures (PROMs) assessing health related quality of life (HRQoL) or similar constructs related to an intestinal stoma and to evaluate their level of validation. METHODS: The study was reported in line with PRISMA guidelines. The protocol was registered in PROSPERO prior to the study. Eligible studies were any study investigating psychometric properties of a stoma-specific PROM. The databases MedLine, Embase, CINAHL and Cochrane Libraries were searched for eligible studies. Studies were screened on title and abstract, then full-text for eligibility. Data extraction on the study populations, PROM characteristics, psychometric properties as well as quality assessment using the COSMIN Risk of Bias checklist was performed. RESULTS: In total, 40 studies were included concerning the development and/or validation of 21 PROMs. For most PROMs, few psychometric properties were assessed. In general, quality of content validity was poor, quality of construct validity and reliability was good. Assessment of responsiveness was lacking. CONCLUSION: This systematic review offers an overview of existing PROMs measuring stoma-related HRQoL and their psychometric properties. A large number of PROMs exist and their measures overlap considerably. The PROMs generally have a low level of validation, emphasizing the need for future studies to further validate existing PROMs, rather than developing new ones.
