scholarly journals Efficacy of patent foramen ovale closure for treating migraine: a prospective follow-up study

2020 ◽  
Vol 69 (1) ◽  
pp. 7-12
Author(s):  
Yi Qi ◽  
Yushun Zhang ◽  
Xiaohui Luo ◽  
Gesheng Cheng ◽  
Yajuan Du ◽  
...  

This study aims to evaluate the potential of percutaneous patent foramen ovale (PFO) closure to improve the headache in patients with migraine and PFO, and discuss the difference between the randomized controlled trials (RCTs) and the single-center studies. Patients of migraine with a large shunt of PFO, who experienced ≥2 headache attacks per month and failed ≥2 categories of standardized medication, underwent PFO closure in First Affiliated Hospital of Xi'an Jiao Tong University. The clinical outcomes, including frequency and duration of headache attacks, Headache Impact Test (HIT-6) score, and Visual Analogue Scale (VAS) score, were evaluated at 3, 6, and 12 months of follow-up after the PFO closure. The different efficacies of the clinical outcomes between patients with and without aura as well as different grades of PFO were also evaluated, respectively. 134 patients with migraine (39 male and 95 female) with PFO were enrolled, whose average age was 39.21±11.37 years. After PFO closure, there was a significant reduction in frequency and duration of headache attacks, HIT-6 score, and VAS score at 3, 6, and 12 months’ follow-up (p<0.001). Migraine was completely relieved in 54 (40.30%) patients during 12 months’ follow-up. The frequency of migraine was reduced by >50% in 44 (32.84%) patients at 3 months’ follow-up and increased to 48 (35.82%) at 12 months’ follow-up. 31.03% patients remained residual shunt after 6 months of closure with varying improvements of headache. This study confirmed that PFO closure can effectively reduce frequency and duration of migraine and improve quality of life, but the definitive indications and long-term effect still need further research.

2009 ◽  
Vol 5 (1) ◽  
pp. 71
Author(s):  
Bernhard Meier ◽  

The relative risk of a thromboembolic event is four-fold higher in the 25–35% of adults with a patent foramen ovale (PFO) and 33-fold higher in patients who also have an atrial septal aneurysm. The American PICSS trial showed a yearly incidence of stroke or death after an initial event of 5% with warfarin and 9% with acetylsalicylic acid. The presence of a PFO more than doubles the mortality rate in patients with clinically relevant pulmonary embolism. The risk of a PFO increases with age. Proof of effectiveness in migraine alleviation is likely to be achievable in a couple of years – much quicker than in prevention of paradoxical embolism. Percutaneous closure of PFO has been performed with various devices at the University Hospital Bern in Switzerland since April 1994, with over 1,000 patients treated. At the last available transoesophageal echocardiogram, a significant residual shunt persisted in 4% with Amplatzer devices and 17% with other devices. During follow-up, a recurrent embolic event was observed in 1.6% of patients per year – less than would be expected under medical treatment. Several randomised multicentre trials comparing catheter closure with medical treatment have been started. The PC and CLOSURE trials are in the follow-up phase; results cannot be expected before 2010, and they may well be ‘falsely’ neutral because the follow-up is rather short for the low-risk patients randomised. In a matched control study on patients with cryptogenic stroke and a PFO, 158 patients were treated medically and 150 concomitant patients underwent percutaneous PFO closure. At four years, PFO closure resulted in a trend towards risk reduction of death, stroke or transient ischaemic attack (TIA) (9 versus 24%; p=0.08) compared with medical treatment. The calculated occurrence of patients with cryptogenic strokes associated with a PFO amounts to somewhere between 100 and 300 per year and per million population, corresponding to more than 10% of yearly coronary angioplasty cases. Coronary and peripheral paradoxical emboli without prior exclusion of competing causes plus the presumed associations between PFO and migraine or decompression illness in divers open additional vast fields of potential indications for catheter closure. Finally, the linearly decreasing prevalence of a PFO with age suggests a weeding out of PFO carriers (unless spontaneous closure is assumed). A PFO represents a lethal threat that increases with age. It can be closed percutaneously in 15 minutes virtually free of complications. The patient can resume unrestricted physical activities a few hours after the intervention.


Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Pablo Rengifo-Moreno ◽  
Ignacio Cruz-Gonzalez ◽  
Roberto J Cubeddu ◽  
Maria Sanchez-Ledezma ◽  
Mingming Ning ◽  
...  

Background: The presence of a patent foramen ovale (PFO) is associated with higher rates of cryptogenic stroke. In patients with hypercoagulable states, the incidence of recurrent cerebral ischemic events may be greatly increased if a PFO is present. Percutaneous PFO closure is an alternative therapeutic approach for patients with both conditions who are not candidates for long-term anticoagulation, or have developed recurrent neurological events despite medical therapy. Methods: Between January 1995 to February 2007, 424 consecutive patients with PFO and cryptogenic stroke underwent percutaneous PFO closure. Of these, we identified 112 (26%) patients with a hypercoagulable disorder. We compared the safety and long-term outcome of percutaneous PFO closure in these two groups of patients. Results: Patients with thrombophilia were older (51.7±13 vs 48.3±14 years, p = 0.025), yet no different regarding baseline demographics or echocardiographic characteristics. Percutaneous PFO closure was successful in all the patients. There were no differences in the type of device used (Amplatzer: 53.6 vs 50%, Cardioseal 39.3 vs 41.7%, Sideris 7.1 vs 8.3%; p= 0.78). At median follow-up of 14.3 months (interquartile range: 6.1–31.4 months) there rate of stroke/TIA was similar for both groups (1.7 vs 1.6%, log rank test p = 0.35). At follow-up echocardiography, the rate of complete PFO closure was greater in the thrombophilic patients (97.3 vs 91.7%, p=0.04). Conclusions: Percutaneous PFO closure is safe and effective in preventing recurrent ischemic cerebral events in patients with thrombophilia.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
V Ferreira ◽  
L Almeida Morais ◽  
L Sousa ◽  
A Fiarresga ◽  
J.D Martins ◽  
...  

Abstract Background Percutaneous Patent Foramen Ovale (pPFO) closure benefits for secondary prevention after cardio-embolic stroke have recently been proved. With the increasing number of cases and procedures, a concern with new onset atrial fibrillation (NOAF) has been raised. Purpose To evaluate long-term outcome regarding NOAF rate and to identify its predictors and clinical impact, in a real population submitted to pPFO closure. Methods From 2000 to 2017, consecutive patients (P) submitted to pPFO closure in a tertiary centre were prospectively enrolled. The primary endpoint was NOAF rate and secondary endpoints were all-cause, neurologic and cardiac mortality rates and recurrent ischemic events. Previous and follow-up electrocardiographic, echocardiographic and 24-hour heart rhythm monitoring data were analysed. Follow-up was performed through medical visits, medical charts consultation and a phone call based system, in order to assess clinical status, on-going treatment and events. Results 496 patients were submitted to pPFO. Immediate success was achieved in 98.8% and 9.1% presented a residual shunt on the 1st year TEE. Mean age was 45.0±11.2 years-old with 50.2% of males. The prevalence of hypertension, hypercholesterolemia and atrial septum aneurysm (ASA) was 25.7%, 45.0% and 46.3%, respectively. Pre-procedural mean left atrial (LA) diameter was 36.0±5.3 mm. FU data was available for 490 (98.6%), for a mean FU time of 7.41±3.51 years. 34 P (6.9%) presented ischemic events recurrence (26 strokes and 8 TIA). The primary endpoint was observed in 21 P (4.3%) during the FU period. Median time to 1st AF episode since PFO closure was 5.90±5.53 years. 11 P (52.3%) initiated oral anticoagulation. In univariate analysis, age (44.6±11.3 vs 51.8±6.0 years, p=0.005) and hypertension (24.7% vs 47.6%, p=0.019) were predictors of NOAF in this population. In multivariated analysis, only age remained a predictor of NOAF (OR 1.05 (1.007–1.101), p=0.025). LA pre pPFO closure dimensions, ASA, device type or size and the presence of residual shunt in TEE were not determinants of AF occurrence. The incidence of NOAF was associated with the need for hospitalization due to cardiac causes (19% vs 3.2%, p=0.001) and a trend towards higher rate of recurrent stroke (4.9% vs 14.3%, p=0.06). Conclusion Despite being a highly successful and safe procedure in most patients, pPFO closure was associated with a non-negligenciable rate of NOAF during long-term follow-up. NOAF predictors were related with classical cardiovascular risk factors, such as age and hypertension. None of the procedure or device features were associated with NOAF. Yet, a clinical impact was attributed to NOAF, with more hospitalizations and a trend towards ischemic events recurrence. As young patients submitted to pPFO closure grow older, prevention strategies to diagnose and treat NOAF should be endeavoured. Funding Acknowledgement Type of funding source: None


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
C Hamm ◽  
O Doerr ◽  
M Haas ◽  
L Schulz ◽  
T Koerschgen ◽  
...  

Abstract Background Patent foramen ovale (PFO) closure is the treatment of choice after cryptogenic stroke according recent evidence. The indication is based on results of several randomized controlled trials; however, the results of these trials may not be extrapolated to a real-world clinical setting. Therefore, the aim of the present study was to evaluate long-term outcome regarding recurrent stroke, migraine, and/or peripheral embolism in patients after PFO closure. Methods We retrospectively analyzed outcomes of consecutive patients undergoing PFO closure from 2011 to 2018 at two interventional sites with respect to periprocedural events occurring during hospitalization and long-term follow-up. Follow-up data were collected from outpatient visits or telephone interviews. Results The analysis included 214 consecutive patients (mean age 52 years; 58% male). The follow-up rate was 96% and the mean follow-up time was 38 (SD 22) months. The index vascular event leading to PFO closure was stroke (n=190; 89%), including patients with repetitive stroke (n=36), embolic myocardial infarction (n=21), and migraine (n=3). One quarter (24.6%) of the population studied had an atrial septal aneurysm (>15 mm). Procedural success was achieved in 98%. There were no procedure-related strokes or deaths. Periprocedural complications occurred in 16 patients (7%): two cases of pericardial tamponade, seven complications at the access site mainly caused by bleeding, two cases of transient atrial fibrillation, and five other complications. The Amplatz Septal Occluder™ was used in two thirds (64.5%) of the cases and the Gore Cardioform™ device in one third (28.6%). Four (2%) patients died during follow-up. None of these patients experienced a recurrent stroke. Ten (5%) other patients experienced a recurrent stroke. Patients with recurrent stroke events were older than patients without recurrent stroke (mean 62.6 [SD 8.8] years vs. mean 52.2 [SD 13.8] years; p=0.015) and had a higher rate of preexisting cerebrovascular occlusive disease (5 [50%] vs. 10 [6%]; p<0.0001). There was no difference in risk for recurrent stroke between patients with one prior stroke and more than one stroke before PFO closure (p=0.71). Atrial fibrillation occurred in 6.6% of the patients during follow-up, but only one of these patients had recurrent stroke. No other anatomic and vascular risk factors or antithrombotic treatments were identified as being predictive of embolic events after closure. Conclusion In this real-world PFO closure cohort the recurrent stroke rate is low, although it is higher than reported in the recent randomized controlled trials. Recurrent strokes after PFO closure may reflect additional comorbid risk factors such as age or cerebrovascular occlusive disease that are unrelated to the potential for paradoxical embolism.


Neurology ◽  
2021 ◽  
pp. 10.1212/WNL.0000000000012188
Author(s):  
Wenjun Deng ◽  
David McMullin ◽  
Ignacio Inglessis-Azuaje ◽  
Joseph J. Locascio ◽  
Igor F. Palacios ◽  
...  

Objective:To determine the influence of patent foramen ovale (PFO) closure on circulatory biomarkers.Methods:Consecutive PFO-related stroke patients were prospectively enrolled and followed with serial sampling of cardiac atrial and venous blood, pre and post PFO closure over time. Candidate biomarkers were identified by mass spectrometry in a discovery cohort first, and lead candidates were validated in an independent cohort.Results:PFO stroke patients (n=254) were recruited and followed up to four years (median: 2.01; IQR: 0.77∼2.54). Metabolite profiling in discovery cohort (n=12) identified homocysteine as the most significantly decreased factor in intra-cardiac plasma after PFO closure (FDR=0.001). This was confirmed in validation cohort (n=181), where intra-cardiac total homocysteine (tHcy) reduced immediately in patients with complete closure, but not in those with residual shunting, suggesting association of PFO shunting with tHcy elevation (β: 0.115; 95% CI: 0.047∼0.183; p=0.001). tHcy reduction was more dramatic in left atrium than right (p<0.001), suggesting clearance through pulmonary circulation. Long-term effect of PFO closure was also monitored and compared to medical treatment alone (n=61). Complete PFO closure resulted in long-term tHcy reduction in peripheral blood, whereas medical therapy alone showed no effect (β: -0.208; 95% CI: -0.375∼-0.058; p=0.007). Residual shunting was again independently associated with persistently elevated tHcy (β: 0.184; 95% CI: 0.051∼0.316; p=0.007).Conclusions:PFO shunting may contribute to circulatory tHcy elevation, which is renormalized by PFO closure. PFO is not just a door for clots, but may itself enhance clot formation and injure neurovasculature by clot-independent mechanisms. Biomarkers such as tHcy can potentially serve as cost-effective measures of residual shunting and neurovascular risk for PFO stroke.


Author(s):  
X. Jin ◽  
Y. M. Hummel ◽  
W. T. Tay ◽  
J. F. Nauta ◽  
N. S. S. Bamadhaj ◽  
...  

Abstract Background Transcatheter atrial septal defect (ASD) and patent foramen ovale (PFO) closure might have opposite short- and long-term haemodynamic consequences compared with restricted interatrial shunt creation, which recently emerged as a potential treatment modality for patients with heart failure with preserved ejection fraction (HFpEF). Given the opposing approaches of ASD and PFO closure versus shunt creation, we investigated the early and sustained cardiac structural and functional changes following transcatheter ASD or PFO closure. Methods In this retrospective study, adult secundum-type ASD and PFO patients with complete echocardiography examinations at baseline and at 1‑day and 1‑year follow-up who also underwent transcatheter closure between 2013 and 2017 at the University Medical Centre Groningen, the Netherlands were included. Results Thirty-nine patients (mean age 48 ± standard deviation 16 years, 61.5% women) were included. Transcatheter ASD/PFO closure resulted in an early and persistent decrease in right ventricular systolic and diastolic function. Additionally, transcatheter ASD/PFO closure resulted in an early and sustained favourable response of left ventricular (LV) systolic function, but also in deterioration of LV diastolic function with an increase in LV filling pressure (LVFP), as assessed by echocardiography. Age (β = 0.31, p = 0.009) and atrial fibrillation (AF; β = 0.24, p = 0.03) were associated with a sustained increase in LVFP after transcatheter ASD/PFO closure estimated by mean E/e’ ratio (i.e. ratio of mitral peak velocity of early filling to diastolic mitral annular velocity). In subgroup analysis, this was similar for ASD and PFO closure. Conclusion Older patients and patients with AF were predisposed to sustained increases in left-sided filling pressures resembling HFpEF following ASD or PFO closure. Consequently, these findings support the current concept that creating a restricted interatrial shunt might be beneficial, particularly in elderly HFpEF patients with AF.


2021 ◽  
Vol 51 (1) ◽  
pp. 63-67
Author(s):  
Björn Edvinsson ◽  
◽  
Ulf Thilén ◽  
Niels Erik Nielsen ◽  
Christina Christersson ◽  
...  

Introduction: Interatrial communication is associated with an increased risk of decompression sickness (DCS) in scuba diving. It has been proposed that there would be a decreased risk of DCS after closure of the interatrial communication, i.e., persistent (patent) foramen ovale (PFO). However, the clinical evidence supporting this is limited. Methods: Medical records were reviewed to identify Swedish scuba divers with a history of DCS and catheter closure of an interatrial communication. Thereafter, phone interviews were conducted with questions regarding diving and DCS. All Swedish divers who had had catheter-based PFO-closure because of DCS were followed up, assessing post-closure diving habits and recurrent DCS. Results: Nine divers, all with a PFO, were included. Eight were diving post-closure. These divers had performed 6,835 dives (median 410, range 140–2,200) before closure, and 4,708 dives (median 413, range 11–2,000) after closure. Seven cases with mild and 10 with serious DCS symptoms were reported before the PFO closure. One diver with a small residual shunt suffered serious DCS post-closure; however, that dive was performed with a provocative diving profile. Conclusion: Divers with PFO and DCS continue to dive after PFO closure and this seems to be fairly safe. Our study suggests a conservative diving profile when there is a residual shunt after PFO closure, to prevent recurrent DCS events.


2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Yangyang Han ◽  
Xiquan Zhang ◽  
Fengwei Zhang

Abstract Background Percutaneous closure of patent foramen ovale (PFO) is routinely performed using plain fluoroscopy in the catheter room. This method results in inevitable radiation damage, adverse effects of contrast agents on kidneys, and high cost. We performed PFO closure with a simplified and economical transesophageal echocardiography (TEE)-only guided approach in the operating room. This study aimed to investigate the feasibility, safety, and effectiveness of the percutaneous closure of PFO by only using TEE. Methods We reviewed the medical records of patients who underwent percutaneous PFO closure at our center from December 2013 to December 2017. A total of 132 patients with PFO and cryptogenic strokes underwent PFO closure by using cardi-O-fix PFO device under TEE guidance. The participants comprised 64 and 68 male and female patients, respectively. The mean age and body weight of the patients were 39.40 ± 13.22 years old (12–68 years old) and 65.42 ± 9.70 kg (40–95 kg), respectively. All patients only received aspirin (3–5 mg/kg body weight, oral administration) for 6 months. Contrast-enhanced transthoracic echocardiography (c-TTE) with Valsalva maneuver was performed during follow-up, and questionnaire surveys were obtained at 3, 6, and 12 months after the procedure. Results All (100%) patients were successfully closed. Follow-ups were conducted for 13 months to 48 months, with an average of 27 months. No severe complications were found during the follow-up period. Paroxysmal atrial fibrillation occurred in 4 patients within 3 months after the procedure. No recurrent stroke or death occurred in all patients during the follow-up period. Transient ischemic attack occurred in one patient 6 months after the procedure. Ten (7.6%) patients had a right-to-left shunt, as demonstrated by c-TTE at 12 months of follow-up. Among the 57 patients suffering from migraine, significant relief or resolution was reported by 42 (73.7%) patients. Conclusion TEE-only guided PFO closure was a safe, feasible, and effective method that did not require the use of X-rays and contrast agents.


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