Long-term Outcomes After Percutaneous Patent Foramen Ovale Closure

doi:10.1097/MAJ.0b013e318276b071

The American Journal of the Medical Sciences

Volume 346, Issue 3, September 2013, Pages 181-186

https://doi.org/10.1097/MAJ.0b013e318276b071 Get rights and content

Abstract

Percutaneous patent foramen ovale (PFO) closure is a treatment for cryptogenic stroke and migraine headache. The goal of this study was to assess long-term outcomes of patients treated with percutaneous PFO closure. Records of patients with percutaneous PFO closure at Emory University Hospital from February 2002 to July 2009 were reviewed. Follow-up telephone questionnaire and chart review assessed recurrent stroke, migraine, and complications. Data was reviewed on 414 consecutive patients. Long-term follow-up was obtained in 207 of patients, and mean follow up was 4.6 ± 2.0 years. Cryptogenic stroke was the primary indication for intervention in 193 (93%) patients. Thirteen (7%) patients had a recurrent neurologic event post closure. In patients with multiple neurological events at baseline, 17% (n = 11) had a recurrent event, compared with 2% (n = 2) of patients with a single neurological event prior to PFO-closure (P < 0.002). Post closure, migraine frequency and severity declined from 4.5 to 1.1 migraine/month (P < 0.01) and 7.2 to 3.6 out of 10 (P < 0.01) in patients with history of migraine (n = 60). Thirty-day mortality was 1% (n = 2). One patient had device erosion 5 years post-procedure requiring emergent surgery. Atrial fibrillation was newly diagnosed in 8 (4%) patients within 6 months. In conclusion, the long-term rate of recurrent stroke after PFO closure is low in patients with a single neurological event at baseline. Serious long-term complications after PFO closure are rare. PFO closure may decrease the frequency and severity of migraine.

Section snippets

METHODS

We reviewed the medical records of all consecutive adult patients who underwent percutaneous PFO closure at Emory University Hospital between February 2002 and July 2009. The study was approved and performed in accordance with the regulations of the hospital institutional review board (Emory University Hospital, Atlanta, GA).

Patient Population

Four hundred and fourteen adult patients had undergone percutaneous PFO closure at our institution. At a mean follow-up of 4.6 ± 2.0 years (range, 1.1–8.4 years), 207 patients who had undergone percutaneous PFO closure at our institution were contacted for interview. There was no significant difference in baseline characteristics of contacted and non-contacted patients, except that contacted patients were older (55.3 ± 13.8 years versus 50.3 ± 13.3 years, P < 0.01; Table 1). Additional analysis was

DISCUSSION

This long-term study demonstrates several findings: (1) recurrent stroke or TIA occurred at a low rate post-closure in patients with a single event at baseline; (2) major complications, such as death, and device explantation were rare; (3) atrial fibrillation was newly diagnosed in several patients during follow-up and (4) percutaneous PFO closure improved the self- reported severity and frequency of migraine headaches.

Patients with a single neurologic event at baseline may represent a

LIMITATIONS

Limitations of our observational hypothesis-generating study include the lack of a medically treated comparison group, incomplete follow-up, nonstandardized antithrombotic therapy post-PFO closure and potential involvement of placebo effect relating to migraine improvement. Though baseline and acute procedural outcomes were not significantly different, the patients without follow-up may have introduced bias on long- term outcomes. The majority of patients were referred from outside

CONCLUSIONS

Our study reports long-term follow-up of patients treated with PFO closure for CS or TIA. Patients with a single neurologic event at baseline may represent a lower-risk group for future TIA or stroke. This group may be appropriate for device therapy, which has a relatively low rate of complications over the long- term. Patients with multiple neurologic events at baseline represent a special group at highest risk for recurrent events after closure, despite medical therapy. This group will

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Cited by (7)

Cardiac tamponade following aortic root erosion by an Amplatzer PFO-Occluder in a 41-year-old woman: Only a matter of sizing?
2021, Journal of Cardiology Cases
Citation Excerpt :
There are only two reports of late cardiac erosion in the literature. One – using the Cardiastar device (cardia, Inc., Eagan MN, USA) – about 1 year after implantation and a second (type of device not reported) as late as 5 years after implantation [8,9]. The patient started using whole-body vibration with the intention to lose weight about 3 months before the incident.
A 41-year-old woman who had suffered an acute stroke underwent closure of a persistent patent foramen ovale (PFO) two months later. Eleven months after PFO closure the patient was hospitalized with signs of cardiogenic shock due to cardiac tamponade. Imaging studies showed a correct position of the left occluder disc, whereas the right atrial disc was in direct contact with the aortic root. At day 6, the patient underwent surgery via a minimally invasive route under cardiopulmonary bypass. The left atrial disc of the occluder was in a correct position. A too big right atrial disc together with a sharp angle misalignment toward the right atrial wall led to an erosion of the right atrial wall and of the wall of the aortic root. The occluder was explanted and the PFO closed by direct suture.
Given the increasing number of procedures performed, serious and potentially life-threatening complications – even if rare – deserve special attention. Even though device oversizing was the most likely factor causing the erosion, other factors may play a role, as the patient used whole-body vibration starting three months before the incident. This could explain why the event happened as late as 11 months after the initial PFO closure.
<Learning objective: Recent trials have shown that patent foramen ovale (PFO) closure reduces the risk of recurrent stroke after an initial event of cryptogenic stroke in patients younger than 60 years. If PFO closure is performed more frequently, even rare complications have to be considered. Device-induced erosion of adjacent cardiac structures remains a possible short- or long-term complication after PFO closure. This is an unlikely (0.018%) but potentially life-threatening event. An oversized and misaligned device is the central mechanism.>
Coincidental impact of transcatheter patent foramen ovale closure on migraine with and without aura - A comprehensive meta-analysis
2016, Clinical Trials and Regulatory Science in Cardiology
We analyzed the literature to assess the coincidental impact on migraines of transcatheter patent foramen ovale (PFO) closure performed for secondary stroke prevention.
We searched Medline, EMBASE, and the Cochrane database for studies published up until August 2013. We included English-language studies that provided information on complete resolution or improvement in migraine headaches following PFO closure. Two study authors identified 375 original articles and both independently reviewed 32 relevant manuscripts. Data including study methodology, inclusion criteria, PFO closure and migraine outcomes were extracted manually from all eligible studies. Pooled odds (and probability) of resolution or improvement of migraine headaches were calculated using random-effects models.
Twenty studies were analyzed. Most were uncontrolled studies that included a small number of patients with cryptogenic stroke who had undergone PFO closure and had variable time of follow-up. The probability of complete resolution of migraine with PFO closure (18 studies, 917 patients) was 0.46 (95% confidence interval 0.39, 0.53) and of any improvement in migraine (17 studies, 881 patients) was 0.78 (0.74, 0.82). There was evidence for publication bias in studies reporting on improvement in migraines (Begg's p = 0.002), but not for studies on complete resolution of migraine (p = 0.3). In patients with aura, the probability of complete resolution of migraine post-PFO closure was 0.54 (0.43, 0.65), and in those without aura, complete resolution occurred in 0.39 (0.29, 0.51).
Among patients with unexplained stroke and migraine undergoing transcatheter PFO closure, resolution of headaches occurred in a majority of patients with aura and for a smaller proportion of patients without aura.
Migraine and atrial fibrillation: a systematic review
2022, European Journal of Neurology
Recent advance in patent foramen ovale closure for treatment of migraine
2021, Chinese Journal of Neuromedicine
Experience with percutaneous transcatheter closure of interatrial communications at the cardiovascular center of puerto rico and the caribbean
2015, Puerto Rico Health Sciences Journal
Clinical course and prognosis at isolated patent foramen ovale
2015, Journal of Clinical and Analytical Medicine

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: The authors have no financial or other conflicts of interest to disclose.

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Clinical InvestigationLong-term Outcomes After Percutaneous Patent Foramen Ovale Closure

Abstract

Section snippets

METHODS

Patient Population

DISCUSSION

LIMITATIONS

CONCLUSIONS

Mayo Clin Proc

Mayo Clin Proc

Lancet

J Am Coll Cardiol

Lancet

Lancet

Patent foramen ovale and cryptogenic stroke in older patients

N Engl J Med

Effect of medical treatment in stroke patients with patent foramen ovale: patent foramen ovale in Cryptogenic Stroke Study

Circulation

Prevalence of patent foramen ovale in patients with stroke

N Engl J Med

Interatrial septal abnormalities and stroke: a meta-analysis of case-control studies

Neurology

Potential source of cerebral embolism in migraine with aura: a transcranial Doppler study

Neurology

Prevalence and size of directly detected patent foramen ovale in migraine with aura

Neurology

Relationship between migraine and cardiac and pulmonary right-to-left shunts

Clin Sci (Lond)

Clinical Investigation
Long-term Outcomes After Percutaneous Patent Foramen Ovale Closure