P3721Clinical and echocardiographic outcomes after treatment of patent foramen ovale with two transcatheter occlusion devices: mononcenter observational study

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Almalla ◽  
J Schroeder ◽  
E Altiok ◽  
M N Alashkar ◽  
A Kirschfink ◽  
...  

Abstract Background Percutaneous closure of patent foramen ovale (PFO) after cryptogenic stroke (CS) is strongly recommended in the current guidelines. Most available evidence has been obtained from randomized studies in which Amplatzer PFO occluder device or Groe occluder device were implanted. Several occluder devices are used off-label for percutaneous treatment of PFO. Rate of recurrent CS and rate of residual shunting after percutaneously occlusion of PFO varies between different occlusion devices. To date, there are no randomized clinical studies that compare the effectivity and safety of several devices in patients with CS. Aim The aim of this study was to compare rate of residual shunting and recurrent CS after percutaneus treatment of PFO with the most common used PFO occluder devises. Methods This was a retrospective, non-randomized, monocenter study. Between 2008 and 2014, all patients with CS or transient ischemic attack (TIA) treated with transcatheter occlusion of PFO with Amplatzer PFO occlusion device or Occlutech occlusion device were included. Patients were followed up at 1 and 6 months with contrast-enhanced transesophageal echocardiography (TEE), and at 3 months with contrast-enhanced transthoracic echocardiography. Primary endpoint was residual shunting at 6 months. Secondary endpoint was recurrent CS or TIA at 6 months after the procedure. Results 220 consecutive patients (57±12 year, 131 men) were treated with Amplanz PFO occlusion device (140 patients) or Occlutech PFO occlusion device (80 patients) after CS or TIA. Procedural success was 100% in both groups. Residual shunting was observed directly after the procedure in 26 patients in the Amplatzer group and 22 patients in the Occlutech group (19% and 27%, respectively; p=0.003), at 1 months follow (15% and 25%, respectively; p=0.064) and at 6 months (9% and 16%, respectively; p=0.024). There was no significant difference between both groups according recurrent CS (0.7% and 0%, respectively; p=0.449). At 6 months follow up atrial fibrillation was detected in 2 patients from Amplatzer group and 5 patients from Occlutech group (1.4% and 6.0%, respectively; p=0.050). Death, aortic erosion and pericardial effusion was not observed in both groups. Clinical and echocardiographic outcome Variable Amplatzer occluder device (N=140) Occlutech occluder device (N=80) p-value Clinical outcome at 6 months follow up   Death, n (%) 0 (0%) 0 (0%) 1.000   Stroke, n (%) 1 (1%) 0 (0%) 0.449   Transient ischemic attack, n (%) 0 (0%) 0 (0%) 1.000   Atrial fibrillation, n (%) 2 (1.4%) 5 (6%) 0.050   Aortic erosion, n (%) 0 (0%) 0 (0%) 1.000   Pericardial effusion, n (%) 0 (0%) 0 (0%) 1.000 Echocardiographic Outcome at 6 months follow up   Residual shunting after Implantation directly, n (%) 26 (19%) 22 (27%) 0.003   Residual shunting at one month, n (%) 21 (15%) 20 (25%) 0.064   Residual shunting at 6 months, n (%) 13 (9%) 16 (20%) 0.024 Conclusion Percutaneous treatment of PFO after CS or TIA with Amplatzer PFO occluder device was associated with lower rate of residual shunting and lower rate of atrial fibrillation at 6 months follow up, whereas rate of recurrent CS and TIA was comparable between both groups.

Stroke ◽  
2021 ◽  
Vol 52 (5) ◽  
pp. 1653-1661
Author(s):  
Jessie Ze-Jun Chen ◽  
Vincent N. Thijs

Background and Purpose: Multiple studies evaluated whether patent foramen ovale (PFO) closure reduces the risk of ischemic stroke. One commonly reported complication of PFO closure is the development of atrial fibrillation (AF), which is itself a powerful stroke risk factor that requires specific management. This study aims to evaluate the frequency of AF in patients post-percutaneous closure of PFO and the clinical factors that predict AF detection. Methods: Studies were identified by systematically searching EMBASE and MEDLINE databases on July 11, 2019. Meta-analysis of proportions was performed, assuming a random-effects model. Results: A total of 6 randomized controlled trials and 26 observational studies were included, comprising 3737 and 9126 patients, respectively. After PFO closure, the rate of AF development was 3.7 patients per 100 patient-years of follow-up (95% CI, 2.6–4.9). The risk of AF development is concentrated in the first 45 days post-procedure (27.2 patients per 100 patient-years [95% CI, 20.1–34.81], compared with 1.3 patients per 100 patient-years [95% CI, 0.3–2.7]) after 45 days. Meta-regression by age suggested that studies with older patients reported higher rate of AF ( P =0.001). In medically treated patients, the rate of AF development was 0.1 per 100 patient-years of follow-up (95% CI, 0.0–0.4). Closure of PFO is associated with increased risk of AF compared with medical management (odds ratio, 5.3 [95% CI, 2.5–11.41]; P <0.001). Conclusions: AF is more common in PFO patients who had percutaneous closure compared with those who were medically treated. The risk of AF was higher in the first 45 days post-closure and in studies that included patients with increased age.


Stroke ◽  
2021 ◽  
Author(s):  
Steven R. Messé ◽  
Guray Erus ◽  
Michel Bilello ◽  
Christos Davatzikos ◽  
Grethe Andersen ◽  
...  

Background and Purpose: Randomized patent foramen ovale closure trials have used open-label end point ascertainment which increases the risk of bias and undermines confidence in the conclusions. The Gore REDUCE trial prospectively performed baseline and follow-up magnetic resonance imaging (MRIs) for all subjects providing an objective measure of the effectiveness of closure. Methods: We performed blinded evaluations of the presence, location, and volume of new infarct on diffusion-weighted imaging of recurrent clinical stroke or new infarct (>3 mm) on T2/fluid attenuated inversion recovery from baseline to follow-up MRI at 2 years, comparing closure to medical therapy alone. We also examined the effect of shunt size and the development of atrial fibrillation on infarct burden at follow-up. Results: At follow-up, new clinical stroke or silent MRI infarct occurred in 18/383 (4.7%) patients who underwent closure and 19/177 (10.7%) medication-only patients (relative risk, 0.44 [95% CI, 0.24–0.81], P =0.02). Clinical strokes were less common in closure patients compared with medically treated patients, 5 (1.3%) versus 12 (6.8%), P =0.001, while silent MRI infarcts were similar, 13 (3.4%) versus 7 (4.0%), P =0.81. There were no differences in number, volumes, and distribution of new infarct comparing closure patients to those treated with medication alone. There were also no differences of number, volumes, and distribution comparing silent infarcts to clinical strokes. Infarct burden was also similar for patients who developed atrial fibrillation and for those with large shunts. Conclusions: The REDUCE trial demonstrates that patent foramen ovale closure prevents recurrent brain infarction based on the objective outcome of new infarcts on MRI. Only clinical strokes were reduced by closure while silent infarctions were similar between study arms, and there were no differences in infarct volume or location comparing silent infarcts to clinical strokes. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT00738894.


Author(s):  
Samia Ashour Mohamed ◽  
Mohamed Ayman Saleh ◽  
Hala Mahmoud ELKhawas ◽  
Eman Saleh ElHadidi ◽  
Ahmed ElSadek ◽  
...  

Abstract Background Contrast-enhanced transcranial duplex (c-TCD) might be more sensitive than transesophageal echo (TEE) for detection of right to left shunting (RLS), which misses some cases with substantial RLS and might be valuable for prediction of recurrent stroke or transient ischemic attack in patients with PFO. Our aim is to detect sensitivity and specificity of contrast-enhanced TCD in detection of RLS among stroke patients with patent foramen ovale (PFO) in comparison to TEE. Methods TEE and contrast-enhanced TCD for cryptogenic stroke patients with PFO were done to detect right to left shunting. Results On testing characteristics of TCD in detecting RLS compared to the gold standard of TEE, TCD sensitivity was 85.7%, specificity was 100%, negative predictive value was 96.55%, and positive predictive value was 100%. Conclusion We concluded that PFO is considered an important hidden etiology for ischemic stroke. Contrast-enhanced TCD is considered sensitive method for detection of right to left shunting among PFO patients.


2020 ◽  
Vol 5 (1) ◽  
pp. 63-66
Author(s):  
Xiaofei Jiang ◽  
Heng Zhang ◽  
Mingyang Qian

A 26-year-old patient with mirror-image dextrocardia and situs inversus experienced a transient ischemic attack. We suspected that a patent foramen ovale was the reason. A Cardi-O-Fix occluder was used to close the patent foramen ovale with a mirror-reversed rotation of the radiologic views. During the 18-month follow-up, no symptoms of the transient ischemic attack appeared again.


2020 ◽  
Author(s):  
Tianli Zhao ◽  
Qin Wu ◽  
Hendrik Ruge ◽  
Rüdiger Lange ◽  
Yifeng Yang ◽  
...  

Abstract Background Standby of transesophageal echocardiography (TEE) is necessary for any PFO closure in case of some cases with complicated anatomy of patent foramen ovale (PFO). The safety and effectiveness of Transcatheter PFO closure guided only by TEE navigation without fluoroscopy is unclear.Methods From 2017.06 to 2019.11, we included 38 patients who were recommended for PFO closure by the department of neurology at our hospital. The procedure was performed in a regular operating room by TEE navigation without fluoroscopy. Follow-up was given at 1st month, 3rd month, 6th month, 1st year and 2nd year after operation for each patient.Results All 38 patients were successfully performed PFO-closure guided by TEE. Procedural and intrahospital survival was 100%. Survival after a mean follow-up of 17.1±1.6months was 100%. "Catheter in sheath” technique was adopted in 16 cases. After the procedure, all 28 migraines with aura alleviated at different degree. All 10 patients suffering from pre-operational cryptogenic stroke survived and showed no evidence for recurrence of stroke (fatal or non-fatal), peripheral embolism or transient ischemic attack during follow-up. No serious adverse events in the PFO closure procedure and during the follow-up period.Conclusion First clinical experiences showed that percutaneous TEE guided PFO closure is safe and effective and might be promoted.


2016 ◽  
Vol 43 (2) ◽  
pp. 171-174
Author(s):  
Evan P. Kransdorf ◽  
Lisa N. Kransdorf ◽  
F. David Fortuin ◽  
John P. Sweeney ◽  
Susan Wilansky

Patent foramen ovale is a common clinical finding that generally becomes a concern in the presence of transient ischemic attack or stroke. Rarely, patent foramen ovale is associated with hypoxemia in the presence of substantial right-to-left atrial shunting. We present the case of an 86-year-old woman with a pacemaker, who was initially asymptomatic notwithstanding a patent foramen ovale. Over 1.5 years, her symptoms progressed in a stepwise fashion, in the setting of progressive pacemaker-associated tricuspid regurgitation. Ultimately, the patient's symptoms and her hypoxemia resolved after percutaneous closure of her patent foramen ovale with use of a 25-mm “Cribriform” occluder device. This case highlights the fact that clinically significant right-to-left shunting requires an anatomic lesion, such as patent foramen ovale, together with elevated right atrial pressure, which in this case was contributed by severe tricuspid regurgitation.


2020 ◽  
Vol 47 (4) ◽  
pp. 244-249
Author(s):  
Lu He ◽  
Gesheng Cheng ◽  
Yajuan Du ◽  
Yushun Zhang

Percutaneous closure of patent foramen ovale (PFO) is widely performed to prevent recurrent stroke or transient ischemic attack in patients with cryptogenic stroke. However, the influence of different degrees of right-to-left shunting (RLS) has rarely been reported. We retrospectively evaluated the cases of 268 patients with cryptogenic stroke who underwent PFO closure at our hospital from April 2012 through April 2015. In accordance with RLS severity, we divided the patients into 2 groups: persistent RLS during normal breathing and the Valsalva maneuver (n=112) and RLS only during the Valsalva maneuver (n=156). Baseline characteristics, morphologic features, and procedural and follow-up data were reviewed. The primary endpoint was stroke or transient ischemic attack. More patients in the persistent group had multiple or bilateral ischemic lesions, as well as a larger median PFO diameter (2.5 mm [range, 1.8–3.9 mm]) than did patients in the Valsalva maneuver group (1.3 mm [range, 0.9–1.9 mm]) (P &lt;0.001). Atrial septal aneurysm was more frequent in the persistent group: 25 patients (22.3%) compared with 18 (11.5%) (P=0.018). Three patients in the persistent group had residual shunting. The annual risk of recurrent ischemic stroke was similar between groups: 0.298% (persistent) and 0.214% (Valsalva maneuver). Our findings suggest that patients with persistent RLS have more numerous severe ischemic lesions, larger PFOs, and a higher incidence of atrial septal aneurysm than do those without. Although our persistent group had a greater risk of residual shunting after PFO closure, recurrence of ischemic events did not differ significantly from that in the Valsalva maneuver group.


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