PFO closure cannot prevent strokes from other causes; therefore, an analysis of only recurrent ischemic stroke of undetermined cause revealed another significant difference in these strokes occurring in 10 patients in the PFO closure group versus 23 patients in the medical-therapy group (HR, 0.38; 95% CI, 0.18–0.79; P =.007).
Full Answer
Does PFO need to be closed after a stroke?
Closure of PFO after ischemic stroke is beneficial in cases where the PFO was highly likely to have caused the stroke. The best antithrombotic regimen (antiplatelet vs. anticoagulation) for stroke patients with PFO who do not undergo closure is not clear at this time.
What is the association between PFO and cryptogenic stroke?
The association between PFO and cryptogenic stroke was first reported in case-control studies in patients younger than 55 years[15-20], which showed an over four-fold increase in prevalence of PFO in patients with cryptogenic stroke compared with controls (approximately 45% vs. 11%; p<0.001)[21].
What are the risk factors for PFO closure?
In general, patients referred for PFO closure were younger and more likely to have had a previous stroke or TIA, while patients treated medically, on the other hand, were generally older and had higher frequencies of other stroke risk factors, such as diabetes and smoking history[46].
What is the role of patent foramen ovale closure in secondary stroke prevention?
What is the role of patent foramen ovale (PFO) closure in secondary stroke prevention? This is a clinical guideline synopsis created by a group of content experts after review of the eight core PFO closure studies. All patients for whom PFO closure is being considered should have an electrocardiogram to evaluate for atrial fibrillation.
Can you have a stroke after PFO closure?
It was shown that the risk of a stroke was 4.9% lower in patients who underwent a PFO closure plus antiplatelet therapy, compared with the risk of a stroke in patients who received antiplatelet therapy alone. The NNT to avoid one stroke was calculated as 20 (95% CI: 17-25).
Should PFO be closed after stroke?
In particular, patients younger than 60 years old with PFO who have had “cryptogenic,” embolic-appearing stroke with no high-risk alternative stroke mechanism should be considered for closure.
When should a PFO be closed?
There are only a couple of very specific reasons to close a PFO, Dr. Reed says: You've had a stroke or a “mini” stroke, known as a transient ischemic attack (TIA). If you have, then closing the hole can reduce the risk of recurrent strokes.
What is the success rate of PFO closure?
PFO closure in this long-term follow-up study of up to 12.4 years was associated with a very low recurrent event rate of 0.3% per year and a success rate of 99%.
Is PFO closure risky?
Complications from a PFO closure and side effects may include atrial fibrillation, an ischemic stroke as a result of the procedure, bleeding from the site where the device is guided into the body, blood clots in the leg or lung, injury to the heart, or embolization of the device (note that while these complications may ...
What should you not do after a PFO closure?
After 5 days, no heavy activity that causes deep/heavy breathing for 6-8 weeks. No driving for 5 days. No tub baths, swimming, or hot tubs for 7 days. Most patients return to work within one week.
Who benefits from PFO closure?
Research conclusions. This study showed that PFO closure is beneficial in patients with PFO and stroke. It was beneficial in patients who were male, younger than 45, had atrial septal aneurysm and had a large shunt.
Who qualifies for PFO closure?
The AHA/ASA guidelines for the secondary prevention of stroke state that it is reasonable to percutaneously close a PFO in individuals who meet each of the following criteria: age 18–60 years of age, nonlacunar stroke, no other identified cause and high-risk PFO features (Kleindorfer et al., 2021).
Do you need anticoagulation after PFO closure?
“The most recent American Academy of Neurology recommendations . . . in addition to recommending PFO closure in appropriately selected patients also recommends that all patients with a previous stroke should be treated with an antithrombotic regardless of whether a PFO is present or if it's closed,” Krishnaswamy said.
How long can you live with a PFO closure?
Observational studies and meta-analyses suggest that closure is associated with a benefit but evidence from randomized trials, remained inconclusive, with most analyses based on only moderate durations of follow-up, averaging 2 to 4 years.
What percentage of strokes are caused by PFO?
PFO and Stroke CS comprises 15–40% of all ischemic strokes, and PFO occurs in 40–56% in patients <55 years old with CS or transient ischemic attack (TIA) (6, 12, 14). One has to distinguish between PFO being a direct cause of stroke and PFO being a risk factor for stroke.
Does a PFO closure last forever?
Once in the correct location, the PFO closure device is formed so that it straddles each side of the hole. The device will remain in the heart permanently to stop the abnormal flow of blood between the two atrial chambers of the heart.
What is PFO in stroke?
Patent foramen ovale (PFO) is an embryonic defect, seen in up to 25% of adults,¹ that has been associated with increased risk of ischemic stroke of unknown cause. It is defined as an opening in the septum between the atria that acts as a conduit for emboli from the deep veins of the pelvis or legs to the brain. Closure of a PFO may prevent paradoxical embolus from passing through a PFO and thereby reduce the risk of recurrent stroke.
What is PFO closure?
PFO closure is a same-day, outpatient procedure performed under general anesthesia or conscious sedation in a heart catheterization laboratory. The catheter-based procedure involves making a very small skin incision, guided by fluoroscopy and intracardiac echocardiography, typically in the right groin area, and inserting a catheter to guide the Amplatzer™ Talisman™ PFO Occluder through the blood vessels to close the PFO within the patient’s heart.
Study Questions
What is the role of patent foramen ovale (PFO) closure in secondary stroke prevention?
Methods
This is a clinical guideline synopsis created by a group of content experts after review of the eight core PFO closure studies.
Results
All patients for whom PFO closure is being considered should have an electrocardiogram to evaluate for atrial fibrillation. Patients >50 years of age with risk factors for atrial fibrillation (hypertension, obesity, obstructive sleep apnea, etc.) should have at least 28 days of cardiac event monitoring to evaluate for atrial fibrillation.
Conclusions
This guideline synopsis provides a moderate recommendation for PFO closure in patients younger than 60 years who do not have another identifiable cause of stroke after a comprehensive workup.
Perspective
PFOs are common, occurring in up to 25% of the general population. When a PFO is felt to be very likely responsible for a patient’s stroke, PFO closure provides a moderate benefit for patients under the age of 60 years.
Study Questions
What is the efficacy and safety of patent foramen ovale (PFO) closure versus medical treatment in patients with cryptogenic stroke or transient ischemic attack (TIA)?
Methods
The investigators searched PubMed until September 24, 2017, for trials comparing PFO closure with medical treatment in patients with cryptogenic stroke/TIA using the items: stroke or cerebrovascular accident or TIA and PFO or paradoxical embolism and trial or study.
Conclusions
The authors concluded that in patients with cryptogenic stroke/TIA and PFO who have their PFO closed, ischemic stroke recurrence is less frequent compared with patients receiving medical treatment.
Perspective
This updated meta-analysis of randomized controlled trials of PFO closure versus medical treatment reports that patients with cryptogenic stroke/TIA and PFO who have their PFO closed compared with patients receiving medical treatment have lower ischemic stroke recurrence, but not TIA or all-cause mortality or MI or any serious adverse event.
What is the prevalence of PFO?
31.3% in studies using transcranial doppler and only 14.7% in studies using only transthoracic echocardiogram. As expected, PFO prevalence was higher among patients with prior cerebrovascular events vs. those without prior cerebrovascular events, across all different diagnostic modalities and the autopsy series.
What is cryptogenic stroke?
The term cryptogenic strokes is used to define strokes for which a cause cannot be identified and account for almost 40% of all the ischemic strokes. Patent foramen ovale (PFO) can potentially explain some of those strokes since it allows right-to-left shunting and was found to be more common in patients with cryptogenic strokes (40%) vs. the general population (25%). After the long-term results of the RESPECT trial and the publication of Gore REDUCE and CLOSE trials and multiple meta-analyses showing benefit from PFO closure in patients with history of cryptogenic stroke, PFO closure has regained a lot of popularity but is also attracting criticism when performed in patients with borderline indications (2–9). Our aim with this Research Topic was to collect a number of well-conducted primary studies, meta-analyses or state of the art narrative reviews on different questions and controversies regarding PFOs role in cryptogenic strokes. In this editorial, we present and put in context compared to the existing literature, the highlights of the studies of this Research Topic.
Is PFO associated with AF?
On the other hand, the presence of PFO in the setting of ischemic stroke, was shown to be negatively associated with presence of AF , according to a meta-analysis conducted by Ze-Jun Chen and Thijs. The authors included 14 studies and 13,425 patients comparing AF rates in stroke patients with PFO vs. those without a PFO. They found that patients with a PFO were 48% less likely to have AF compared to those without a PFO. Their results remained significant after performing separate analyses for cross-sectional and longitudinal studies and in different age groups (>60 years old vs. <60 years old). Those findings -although potentially subject to detection bias- support that patients with PFO are not at an increased risk of arrhythmia compared to the general stroke population and may actually have a lower risk. Impaired left atrial (LA) mechanical function has been suggested to be one of the possible causes of cryptogenic strokes, since it can be associated with blood stasis and thrombus formation, while a few studies have even associated impaired LA function with presence of PFO. Speckle tracking is one of the non-invasive methods to evaluate the LA function. Gazagnes et al.studied the association between LA longitudinal strain and presence of PFO in patients who presented with cryptogenic stroke. Interestingly, no association was found, even in the subgroup of patients with PFO and atrial septal aneurysm. Their results were probably limited by their small size and future studies are anticipated.
Is PFO a risk factor for stroke?
However, whether PFO (co)existence is the direct cause of stroke in patients with cryptogenic ischemic stroke remains an unanswered question. Ioannidis and Mitsias, in their state-of-the-art review, argue that PFOs can act as the direct cause vs. risk factor , or an even incidental finding in some patients with cryptogenic stroke. They provide an overview of the potential stroke mechanisms including paradoxical embolism, in situclot formation or atrial tachyarrhythmias in the setting of a hypermobile atrial septum. Risk factors include the size and morphology of the PFO and the degree of the shunt. The authors present and explain the Risk of Paradoxical Embolism (RoPE) score and its use in patients with PFO. Low RoPE scores suggest low probability of pathogenic PFO and relatively higher probability of recurrent stroke events while higher RoPE scores suggest higher probability of pathogenic PFO but lower probability of recurrent events. The first of the mechanisms that Ioannidis and Mitsiasproposed and analyzed is paradoxical embolism which originates from concomitant deep vein thrombosis (DVT). It seems that the prevalence of DVT and pulmonary embolism (PE) in those patients is higher than previously thought. Zietz et al.performed a systematic review of the association between DVT/ PE and PFO existence in patients presenting with cryptogenic stroke. They found eight eligible studies in total, with the DVT frequency ranging from 7 to 27% and the PE frequency ranging from 4.4 to 37%. They also examined the reversed association and they found that the presence of PFO in patients with PE was associated with higher rates of ischemic brain lesions. Given those findings, it is probably reasonable to maintain a lower threshold for DVT/PE screening in patients who present with stroke and are subsequently found to have a PFO.
During the procedure
PFO closure is a same-day, outpatient procedure performed under general anesthesia or conscious sedation in a heart catheterization laboratory.
What happens after the PFO Closure Procedure?
After the procedure, the interventional cardiologist will discuss an after-care plan with the patient.
Want to know more about the device?
The Amplatzer™ Talisman™ PFO Occluder significantly lowers the risk of recurrent ischemic stroke, and it offers an excellent safety profile.
Introduction
The optimal secondary prevention strategy in patients presenting with a cryptogenic stroke or transient ischemic attack (TIA) and a patent foramen ovale (PFO) is uncertain. In the United States, closure of a PFO using a percutaneous transcatheter device is currently considered investigational by the Food and Drug Administration.
Methods
CLOSURE I was a prospective, multicenter, randomized, open-label, 2-arm superiority trial. The trial was sponsored by NMT Medical, Inc. The protocol was designed by the Executive Committee in consultation with the Food and Drug Administration, and was approved by the institutional review board at each participating site.
Conclusions
There was no significant difference in the 2-year rate of recurrent stroke and TIA between device and medical therapy in this population of patients with cryptogenic TIA/stroke and a PFO. Major vascular complications occurred in 3% of patients in the device arm.
Footnotes
Correspondence to Anthony J. Furlan, MD, Department of Neurology, Neurological Institute, University Hospitals Case Medical Center, 11100 Euclid Ave, Mail Stop HAN 5040, Cleveland, OH 44106. E-mail [email protected]