scholarly journals Atrial Fibrillation Following Patent Foramen Ovale Closure

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.

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
F Leclercq ◽  
X Odorico ◽  
C Arquizan ◽  
J C Macia ◽  
B Lattuca ◽  
...  

Abstract Background An increased risk of new-onset atrial fibrillation (AF) after patent foramen ovale (PFO) closure was observed in randomized trials. However, systematic screening of AF was not performed in these studies. Purpose We aimed to evaluate incidence of AF in patients undergoing percutaneous PFO closure with serial 24-hours ambulatory electrocardiogram (AECG) monitoring during a 6-months follow-up. Methods All consecutive patients undergoing PFO closure for cryptogenic stroke or decompression sickness (DSC) were prospectively included in 2 centers. AF was defined as an irregular rhythm without discernible P waves lasting at least 30 seconds on 24-hours AECG performed at day 0, 1 month and 6-months follow-up. Primary endpoint was incidence of AF within the study period. Secondary endpoints evaluated clinical outcomes (hospitalization for cardiovascular causes, new stroke or bleeding) within 6-months follow-up. Results Between February 2018 and March 2019, a total of 62 patients underwent PFO closure: 59 (95.2%) for cryptogenic stroke and 3 (4.8%) for DSC. In the overall population, 40 were male (64.5%) and the mean age was 48±9.5 years. An atrial septal aneurysm was present in 37 patients (64.9%). The PFO device mean size was 26±5.0 mm. After a mean follow-up of 33.3±12.2 weeks, new-onset AF occurred in 3 patients (4.8%), all within 1-month after closure and paroxysmal. While symptomatic ectopic atrial heart beats occurred in one fourth of patients, all AF episodes asymptomatic. Two patients (3.2%) required oral anticoagulant therapy according to CHA2DS2-VASc score. No adverse outcomes occurred. Age (RR 1.26 [0.98; 1.61] p=0.3), male sex (p=0.6) and device (p=1.0) were not associated with occurrence of AF but all patients with AF were men and received an Amplatzer device. Conclusion Incidence of AF, evaluated with serial systematic 24-hours AECG during a 6-months follow-up after PFO closure, was relatively low (&lt;5%). Always paroxysmal, AF always occurred within one month after the procedure and was not associated with adverse outcomes. FUNDunding Acknowledgement Type of funding sources: None.


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.


Circulation ◽  
2018 ◽  
Vol 138 (Suppl_1) ◽  
Author(s):  
Krunalkumar Patel ◽  
Nirav Patel ◽  
Rajkumar Doshi ◽  
Jay Shah ◽  
Tapankumar Miyani ◽  
...  

Background: The closure of patent foramen ovale (PFO) by percutaneous transcatheter approach is controversial in a patient with cryptogenic stroke. Here in, we reviewed the literature and analyzed the data on safety and efficacy of standard medical therapy (MT) compared to mechanical closure by the percutaneous trans-catheter approach after recently published DEFENSE-PFO trial. Hypothesis: Transcatheter PFO closure decreases incidence of recurrent stroke compared to standard MT. Methods: We systematically searched PubMed, SCOPUS and EMBASE for the articles that compared overall mortality, efficacy in preventing recurrent stroke, and transient ischemic attack (TIA) after transcatheter PFO closure compared to standard MT. We also evaluated potential complications such as bleeding and development of atrial fibrillation. Results: A total 6 studies with 3,403 patients met pre-defined inclusion criteria. Mean follow-up was 3.75 years. Overall mortality was indifferent between transcatheter closure compared to MT (RR: 0.74, 95% CI 0.35-1.6, P=0.45, I 2= 0%). However, PFO closure reduced the rate of recurrent stroke by at least 60% (RR: 0.39, 95% CI 0.18-0.82, P=0.01, I 2= 56%), while did not reduce the risk of TIA compared to MT (RR: 0.76, 95% CI 0.52-1.12, P= 0.17, I 2 =0%). Higher incidence of atrial fibrillation was evident in mechanical closure (RR: 4.64, 95% CI 2.37-9.09, p<0.00001, I 2 =11%) but no increase in bleeding (RR: 0.88, 95% CI: 0.4-1.93, p=0.74, I 2 =28%). Conclusions: Mechanical PFO closure by transcatheter approach is a viable option in the prevention of recurrent stroke and TIA with an increased risk of development of atrial fibrillation without the risk of bleeding.


F1000Research ◽  
2017 ◽  
Vol 6 ◽  
pp. 2178
Author(s):  
Gary Tse ◽  
William K.K. Wu ◽  
Mengqi Gong ◽  
George Bazoukis ◽  
Wing Tak Wong ◽  
...  

Background: Previous randomized trials on patent foramen ovale (PFO) closure versus medical therapy for stroke prevention were inconclusive. Recently, two new randomized trials and new findings from an extended follow-up of a previous trial have been published on this topic. We conducted a systematic review and meta-analysis of randomized trials comparing PFO closure with medical therapy for stroke prevention. Methods: PubMed and Cochrane Library were searched until 16th September 2017.  The following search terms were used for PubMed: "patent foramen ovale" AND (stroke OR embolism) and "randomized" AND "Trial". For Cochrane Library, the following terms were used: "patent foramen ovale" AND "closure" AND (stroke OR embolism). Results: A total of 91 and 55 entries were retrieved from each database using our search strategy respectively, of which six studies on five trials met the inclusion criteria. This meta-analysis included 1829 patients in the PFO closure arm (mean age: 45.3 years; 54% male) and 1972 patients in the medical therapy arm (mean age: 45.1 years; 51% male). The median follow-up duration was 50 ± 30 months. When compared to medical therapy, PFO closure significantly reduced primary endpoint events with a risk ratio [RR] of 0.60 (95% CI: 0.44-0.83, P < 0.0001; I2: 15%). It also reduced stroke (RR: 0.50, 95% CI: 0.35-0.73, P < 0.0001; I2: 32%) despite increasing the risk of atrial fibrillation/flutter (RR: 1.90, 95% CI: 1.23-2.93, P < 0.01; I2: 43%). However, it did not reduce transient ischemic accident events (0.75; 95% CI: 0.51-1.10, P = 0.14; I2: 0%), all-cause bleeding (RR: 0.89; 95% CI: 0.44-1.78, P = 0.74; I2: 51%) or gastrointestinal complications (RR: 0.92; 95% CI: 0.32-2.70, P = 0.88; I2: 0%). Conclusions: PFO closure significantly reduces risk of stroke when compared to medical treatment and should therefore be considered for stroke prevention in PFO patients.


Neurology ◽  
2018 ◽  
Vol 91 (1) ◽  
pp. e1-e7 ◽  
Author(s):  
Hamidreza Saber ◽  
Mohan Palla ◽  
Shaghayegh Kazemlou ◽  
Mahmoud R. Azarpazhooh ◽  
Navid Seraji-Bozorgzad ◽  
...  

ObjectiveTo compare the outcomes of patent foramen ovale (PFO) closure vs antiplatelet agent (APA) vs oral anticoagulation therapy (OAT) for secondary prevention of stroke in patients with cryptogenic stroke, using direct and indirect evidence from existing randomized data.MethodsRelevant randomized controlled trials were identified by a systematic review. The efficacy outcome was stroke recurrence, and safety outcomes were atrial fibrillation and bleeding complications at the end of follow-up. Bayesian network meta-analysis was performed to calculate risk estimates and the rank probabilities using APA therapy as the reference.ResultsIn a network meta-analysis of 6 randomized controlled trials consisting of 3,497 patients (1,732 PFO closure, 1,252 APA, 513 OAT), PFO closure and OAT were associated with lower rates of recurrent stroke (odds ratio [OR] 0.30, 95% credibility interval [CrI] 0.17–0.49 and OR 0.42, 95% CrI 0.22–0.78, respectively) with equal efficacy of OR 0.70 (95% CrI 0.37–1.49). PFO closure had the highest top rank probability of atrial fibrillation and OAT had the highest risk of bleeding complications.ConclusionsThese findings suggest that closure and OAT may be equally effective in recurrent stroke prevention in patients with PFO. There is an increased risk of atrial fibrillation and bleeding with closure and OAT therapy, respectively. A randomized trial is needed to identify patients who would benefit most from each strategy.


F1000Research ◽  
2018 ◽  
Vol 6 ◽  
pp. 2178
Author(s):  
Jenny Chi Ling Lai ◽  
Gary Tse ◽  
William K.K. Wu ◽  
Mengqi Gong ◽  
George Bazoukis ◽  
...  

Background: Previous randomized trials on patent foramen ovale (PFO) closure versus medical therapy for stroke prevention were inconclusive. Recently, two new randomized trials and new findings from an extended follow-up of a previous trial have been published on this topic. We conducted a systematic review and meta-analysis of randomized trials comparing PFO closure with medical therapy for stroke prevention. Methods: PubMed and Cochrane Library were searched until 16th September 2017.  The following search terms were used for PubMed: "patent foramen ovale" AND (stroke OR embolism) and "randomized" AND "Trial". For Cochrane Library, the following terms were used: "patent foramen ovale" AND "closure" AND (stroke OR embolism). Results: A total of 91 and 55 entries were retrieved from each database using our search strategy respectively, of which six studies on five trials met the inclusion criteria. This meta-analysis included 1829 patients in the PFO closure arm (mean age: 45.3 years; 54% male) and 1972 patients in the medical therapy arm (mean age: 45.1 years; 51% male). The median follow-up duration was 50 ± 30 months. When compared to medical therapy, PFO closure significantly reduced primary endpoint events with a risk ratio [RR] of 0.60 (95% CI: 0.44-0.83, P < 0.0001; I2: 15%). It also reduced stroke (RR: 0.50, 95% CI: 0.35-0.73, P < 0.0001; I2: 32%) despite increasing the risk of atrial fibrillation/flutter (RR: 1.90, 95% CI: 1.23-2.93, P < 0.01; I2: 43%). However, it did not reduce transient ischemic accident events (0.75; 95% CI: 0.51-1.10, P = 0.14; I2: 0%), all-cause bleeding (RR: 0.89; 95% CI: 0.44-1.78, P = 0.74; I2: 51%) or gastrointestinal complications (RR: 0.92; 95% CI: 0.32-2.70, P = 0.88; I2: 0%). Conclusions: PFO closure significantly reduces risk of stroke when compared to medical treatment and should therefore be considered for stroke prevention in PFO patients.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
P Guedeney ◽  
J Silvain ◽  
M Hauguel-Moreau ◽  
C Sabben ◽  
S Deltour ◽  
...  

Abstract Background In the large randomized trials evaluating patent foramen ovale (PFO) closure vs. medical treatment in secondary prevention of stroke, the incidence of atrial fibrillation has been reported more frequently with PFO closure (2.9–6.6%) than with medical treatment (0.4–1.9%). These episodes were clinically reported and may not reflect the real incidence detected by prolonged ECG recording. Purpose To evaluate the incidence and timing of supraventricular tachycardia (SVT) after percutaneous PFO closure. Methods Prolonged cardiac monitoring was proposed to patients undergoing PFO closure at the tertiary center of Pitié Salpétrière Hospital, Paris. According to the estimated risk of SVT, two different approaches were used to monitor cardiac rhythm. A 3-year permanent recording using REVEAL™ XT or LINQ was proposed to high risk patients (age &gt;45 years, multiple CV risk factors, prior palpitations or supraventricular ectopic activity during Holter monitoring prior to the intervention). A 4-week, 15-lead ECG continuous recording using the patch-free, wire-free, wearable Cardioskin™ system was proposed to lower risk patients. Endpoints of interest were the occurrence of SVT episodes (&gt;30 seconds) and unplanned medical consultation or hospitalization for this reason Results From October 2018 to January 2020, a total of 64 patients underwent prolonged ECG monitoring including 32 (50.0%) and 32 (50.0%) patients with Cardioskin™ and REVEAL™ systems, respectively. A SVT was recorded in 11 (17.4%) patients, including atrial fibrillation (AF) in 6 (9.5%) patients. The median delay of SVT occurrence was 33.0 (14.0–39) days after the procedure (Figure 1) and 18 (10.8–34.8) days for the 6 patients with AF. Unplanned hospitalization or emergency medical visit for symptomatic SVT occurred in 5 (45.5%) patients. Antiarrhythmic medication and oral anticoagulation were initiated in 10 (90.1%) and 7 (63.6%) of the 11 patients, respectively, and SVT recurrences were recorded in 5 (45.5%) patients. No stroke was reported in any of the 11 patients during follow-up. There were no significant differences with respect to baseline and procedural characteristics among patients with or without SVT during follow-up. Conclusion Atrial tachycardia is frequent (17.4%) after PFO closure and long-term continuous ECG recording suggests that the incidence is higher than the clinical episodes reported in the randomized trials. This arrhythmic complication of PFO closure seems limited to the first 4 months following the procedure. Larger studies need now to confirm our findings. Figure 1 Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): ACTION coeur


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.


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