Patent foramen ovale closure in the management of cryptogenic stroke: a review of current literature and guideline statements

Abstract

Objective

The management recommendations for patent foramen ovale (PFO) closure in cryptogenic stroke are rapidly evolving. The data has expanded recently with four major trials demonstrating superiority of percutaneous device closure over medical management in preventing cryptogenic stroke recurrence. This paper aims to review the current literature for referring physicians who may encounter patients with patent foramen ovale before referring these patients to stroke specialists and/or interventional cardiologists.

Method

For this Narrative review, we conducted a broad literature search with expert selection of relevant data. Our search included a review of the currently available trials, guideline statements, position papers, cost-effectiveness of device closure data, as well as the impact of device closure on quality of life.

Results

Most European societies are now in favor of evaluating all patients aged 60 years or younger with recent cryptogenic stroke in the setting of a PFO after careful consideration of the patient’s echocardiographic and clinical risk factors. On the other hand, American societies, except for the American Academy of Neurology, have not yet passed official updated recommendations.

Conclusion

PFO closure can be considered for the prevention of recurrent cryptogenic stroke in patients aged ≤60 years after a thorough evaluation and discussion about benefits and potential risks (including but not limited to atrial fibrillation) of the procedure. Accumulating evidence supports prognostic, quality of life, and economic benefit from percutaneous PFO closure with newer generation closure devices in the right subset of patients.

HIGHLIGHTS

• Data from 4 major trials (RESPECT, CLOSE, DEFENSE-PFO, REDUCE) demonstrates the superiority of PFO closure over medical management alone in preventing cryptogenic stroke recurrence. Trials investigated mostly patients ≤60 years old, and therefore results may not be generalizable to the entire population. Further randomized trials evaluating the safety and efficacy of PFO closure in patients older than 60 years are warranted.

• Atrial fibrillation is one of the most common “occult” causes of cryptogenic stroke and should be excluded by ambulatory electrocardiographic monitoring. It is important to also rule out other causes of stroke, including hypercoagulable states, atherosclerotic lesions, other cardioembolic sources, and arterial dissection.

• Complications of PFO procedure include new-onset AF, development of scar tissue, risk of aortic root dilation and subsequent erosions, and potential thrombi formation on the device.

• PFO closure with medical therapy is more cost-effective than medical therapy alone.

• Patients who underwent PFO closure had lower rates of depression, anxiety, and stress compared to those who did undergo closure.

• Development of the RoPE score has helped clinicians identify patients with cryptogenic stroke and PFO who might be a candidate for PFO closure. A score of 7, 8, and 9–10 corresponds to a causal risk of 72%, 84%, and 88%, respectively, and defines a subset of patients who may benefit from PFO closure.

• Current guidelines recommend determining the need for PFO closure on a case-by-case basis, depending on risk factors, in patients age 60 or less with recent cryptogenic stroke in the setting of PFO.

Keywords:

• Amplatzer PFO Occluder
• cryptogenic stroke
• occluder device
• PFO
• patent foramen ovale closure

Transparency

Declaration of funding

This paper was not funded.

Declaration of financial/other relationships

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgements

None stated.

Notes

i GORE is a registered trademark of W. L. Gore and Associates, Inc., Newark, DE, USA.