When Should Physicians Consider Referring Elderly Patients with Suspected PFO-Related Stroke for Device Closure?

Sep 30, 2026

Guidelines support patent foramen ovale (PFO) closure for secondary prevention after cryptogenic stroke in adults aged 18–65, yet evidence remains limited for elderly patients. This structured review evaluates efficacy, safety, and trial quality of studies comparing PFO closure versus medical therapy alone (MTA) in patients aged 60+ identified through PubMed. Among 644 elderly patients, closure reduces recurrent cerebral ischaemia and mortality, improves disability outcomes, but increases new-onset atrial fibrillation. Heterogeneity, crossover, and baseline imbalances limit certainty, supporting larger standardized trials.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages13

Reading Time33 min

AccessFree to download

Abstract

Background

Methods

Results

Conclusions

1. Introduction

Guideline recommendations and decision-making

Prevalence and evidence gaps

Aim of the review

2. Materials and Methods

Literature search and paper selection

Analysis

Review When Should Physicians Consider Referring Elderly Patients with Suspected PFO-Related Stroke for Device Closure? Alisha Varia * and David Roberts Academic Editor: Georgios Tsivgoulis Received: 31 October 2025 Revised: 4 December 2025 Accepted: 24 December 2025 Published: 30 December 2025 Copyright: © 2025 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license. School of Medicine, University of Liverpool, Liverpool L69 3GE, UK; [d.h.roberts@liverpool.ac.uk](d.h.roberts@liverpool.ac.uk) * [Correspondence: hlavaria@liverpool.ac.uk](Correspondence: hlavaria@liverpool.ac.uk) Abstract Background: Guidelines recommend patent foramen ovale (PFO) closure for secondary prevention after cryptogenic stroke in patients aged 18–65 years, but there is limited evidence to guide management of elderly adults. This research aims to assess the efficacy, safety and methodological quality of trials comparing secondary prevention PFO closure with medial therapy alone (MTA) in patients aged ≥ 60 years. Methods: A PubMed search identified four studies comparing PFO closure with MTA in elderly patients—PFOSK (South Korea), PT (Taiwan), DEFENSE (South Korea) and PFOG (Germany) . Primary analyses evaluated study quality—patient selection, allocation, crossover and adherence. Secondary analyses compared recurrent cerebral ischaemia, mortality, new-onset atrial fibrillation (AF) and disability. Results: In 644 patients ≥ 60 years old, PFO closure was associated with a 45%(95% CI 0.35–0.86, p = 0.0091) reduction in recurrent cerebral ischaemia and an 85%(95% CI 0.05–0.49, p = 0.0016) reduction in mortality. Lower disability scores and increased incidence of new-onset AF (RR 2.15, 95% CI 1.07–4.32, p = 0.0306) was observed in closure groups. Study quality was limited by heterogeneity in medical regimens and closure protocols, crossover between treatment arms and imbalances in baseline characteristics, with closure groups generally younger and possessing larger shunt sizes. Conclusions: In patients aged ≥ 60 years, PFO closure appears to reduce the risk of the recurrence of ischaemic events and mortality, particularly in those with ‘high-risk’ PFO features. However, variability in study designs and low event rates limit certainty. Large, standardised trials are warranted to provide evidence for guideline recommendations in this population. Keywords: PFO closure; cryptogenic stroke; elderly 1. Introduction ESC guidelines [1] recommend patent foramen ovale (PFO) closure as secondary prevention in patients aged 18 to 65 years with a cryptogenic stroke. They suggest caseby-case decision-making when patients over 65 present with this condition, providing no single recommendation for treatment [1,2] . NHS England [2] only commissions PFO closure as a secondary prevention in patients aged 60 years and under. Probability of causation has traditionally been determined using the paradoxical embolism (RoPE) score, with scores of seven and above indicating a greater likelihood of PFO causation for a cryptogenic stroke [3] . PFO presence ranges from 16 to 18% in patients above 55 years with a cryptogenic stroke [4], three times more prevalent compared to those patients with stroke of known cause [5] . In a systematic review and meta-analysis by Mazzuco et al., planned stratification by age showed a 150% increased risk of recurrent stroke in the presence of PFO in patients over 65 [6] . Despite this, there remains limited trial evidence exploring the benefits of PFO closure in elderly patients suffering a cryptogenic stroke. This review aims to evaluate evidence for PFO closure in adults aged ≥ 60 years who experience PFO-related cerebrovascular events, specifically compared to those who receive secondary prevention with antiplatelet or anticoagulation therapy alone. 2. Materials and Methods 2.1. L

FAQs

Which age group and condition does the review focus on?

The review focuses on adults aged 60 years and older with PFO-related cerebrovascular events occurring in the context of cryptogenic stroke.

How does PFO device closure compare with medical therapy alone (MTA) in the included elderly studies?

Compared with MTA, PFO closure is associated with reduced recurrent cerebral ischaemia and reduced mortality, with lower disability scores reported in closure groups.

What safety trade-off did the review identify for PFO closure in elderly patients?

PFO closure showed an increased incidence of new-onset atrial fibrillation compared with medical therapy, despite other benefits.

Sep 30, 2026

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