Atrial fibrillation screening on holter monitoring after percutaneous patent foramen ovale closure: a prospective study

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 (<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.

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Atrial Fibrillation Following Patent Foramen Ovale Closure

Stroke ◽

10.1161/strokeaha.120.030293 ◽

2021 ◽

Vol 52 (5) ◽

pp. 1653-1661

Author(s):

Jessie Ze-Jun Chen ◽

Vincent N. Thijs

Keyword(s):

Atrial Fibrillation ◽

Patent Foramen Ovale ◽

Stroke Risk ◽

Meta Analysis ◽

Percutaneous Closure ◽

Foramen Ovale ◽

Stroke Risk Factor ◽

Increased Risk ◽

Pfo Closure

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.

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Closing the Patent Foramen Ovale with Amplatzer Devices

European Cardiology Review ◽

10.15420/ecr.2009.5.1.71 ◽

2009 ◽

Vol 5 (1) ◽

pp. 71

Author(s):

Bernhard Meier ◽

Keyword(s):

Medical Treatment ◽

Patent Foramen Ovale ◽

Cryptogenic Stroke ◽

University Hospital ◽

Atrial Septal Aneurysm ◽

Foramen Ovale ◽

Residual Shunt ◽

Catheter Closure ◽

Pfo Closure

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.

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Importance of Persistent Right-to-Left Shunt After Patent Foramen Ovale Closure in Cryptogenic Stroke Patients

Texas Heart Institute Journal ◽

10.14503/thij-17-6582 ◽

2020 ◽

Vol 47 (4) ◽

pp. 244-249

Author(s):

Lu He ◽

Gesheng Cheng ◽

Yajuan Du ◽

Yushun Zhang

Keyword(s):

Transient Ischemic Attack ◽

Patent Foramen Ovale ◽

Valsalva Maneuver ◽

Recurrent Stroke ◽

Cryptogenic Stroke ◽

Atrial Septal Aneurysm ◽

Foramen Ovale ◽

Ischemic Attack ◽

Pfo Closure

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 <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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Abstract P208: Functional Status, Rehospitalization, and Mortality Outcomes Among Acute Myocardial Infarction Patients with Prior and New-Onset Atrial Fibrillation

Circulation Cardiovascular Quality and Outcomes ◽

10.1161/circoutcomes.4.suppl_2.ap208 ◽

2011 ◽

Vol 4 (suppl_2) ◽

Author(s):

Kyle P Hornsby ◽

Kensey Gosch ◽

Amy L Miller ◽

Jonathan P Piccini ◽

Renato D Lopes ◽

...

Keyword(s):

Myocardial Infarction ◽

Atrial Fibrillation ◽

Acute Myocardial Infarction ◽

Health Status ◽

Functional Status ◽

Physical Function ◽

Adverse Outcomes ◽

Increased Risk ◽

New Onset

Background: Little data are available regarding differences in prognosis and health status between new-onset and prior atrial fibrillation (AF) among patients with acute myocardial infarction (AMI). Methods: The TRIUMPH study enrolled 4340 AMI patients who received longitudinal follow-up including SF-12 health status assessments through 1 year post-AMI. We compared 1-year mortality, rehospitalization, and functional status according to AF type (none, prior, new) after adjusting for differences in baseline characteristics. Results: A total of 212 AMI patients (4.9%) had prior AF and 254 (5.9%) had new-onset AF. Compared with no AF, new AF was associated with older age, male sex, first MI, worse baseline physical function, home atrioventricular nodal blocker use, and worse ventricular function (c-index 0.77). Rates of 1-year mortality were 6.2%, 14.5%, and 13.0%, and 1-year rehospitalization rates were 29.1%, 44.2%, and 36.8% for no, prior, and new AF, respectively. After multivariable adjustment, neither prior nor new AF was associated with increased 1-year mortality, and only prior AF was associated with increased risk of 1-year rehospitalization (Figure). After adjusting for baseline SF-12 physical function scores, patients with prior AF had lower 1-year scores than those with no AF (40.6 vs. 43.7, p <0.003), whereas patients with new AF had similar scores (42.9 vs. 43.7, p=0.36). Conclusion: New-onset AF during AMI is associated with a number of comorbidities but, unlike prior AF, is not associated with adverse outcomes. These results raise the question of whether AF is itself a cause of or simply a marker of comorbidities leading to downstream adverse outcomes after AMI.

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Patent foramen ovale closure by using transesophageal echocardiography for cryptogenic stroke: single center experience in 132 consecutive patients

Journal of Cardiothoracic Surgery ◽

10.1186/s13019-020-1042-4 ◽

2020 ◽

Vol 15 (1) ◽

Cited By ~ 1

Author(s):

Yangyang Han ◽

Xiquan Zhang ◽

Fengwei Zhang

Keyword(s):

Body Weight ◽

Contrast Agents ◽

Transesophageal Echocardiography ◽

Patent Foramen Ovale ◽

Cryptogenic Stroke ◽

Percutaneous Closure ◽

X Rays ◽

Foramen Ovale ◽

Pfo Closure

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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Atrial septal aneurysms in childhood: prevalence, classification, and concurrent abnormalities

Cardiology in the Young ◽

10.1017/s1047951113000607 ◽

2013 ◽

Vol 24 (3) ◽

pp. 453-458 ◽

Cited By ~ 10

Author(s):

Andreas Giannopoulos ◽

Christoforos Gavras ◽

Stavroula Sarioglou ◽

Fotini Agathagelou ◽

Irene Kassapoglou ◽

...

Keyword(s):

Atrial Septal Defect ◽

Patent Foramen Ovale ◽

Septal Defect ◽

Interatrial Septum ◽

Paediatric Population ◽

Point Of View ◽

Atrial Septal Aneurysm ◽

Foramen Ovale ◽

Increased Risk

AbstractObjectives: This study sought to investigate the prevalence of atrial septal aneurysms in the paediatric population and to define coexisting abnormalities and their incidence. Background: Few papers refer to the prevalence of atrial septal aneurysms in childhood. Methods: We enrolled a total of 4522 children aged more than 12 months who underwent a transthoracic echocardiography. Atrial septal aneurysm was defined as a protrusion of the interatrial septum or part of it >15 mm beyond the plane of the atrial septum or phasic excursion of the interatrial septum during the cardiorespiratory cycle of at least 15 mm in total amplitude and a diameter of the base of the aneurysm of at least 15 mm. Results: Atrial septal aneurysms were found in 47 children (1.04%). They involved almost the entire septum in 14 patients (28.89%) and were limited to the fossa ovalis in 33 (71.11%). An atrial septal aneurysm was an isolated structural defect in 17 (35.56%). In 30 (64.44%) patients, it was associated with interatrial shunting – atrial septal defect and patent foramen ovale. At the echo follow-up after a year, no changes were recorded. Conclusions: Prevalence of atrial septal aneurysms is almost 1%. The most common abnormalities associated are interatrial shunts, that is, a patent foramen ovale and an atrial septal defect. From a medical point of view, it is suggested that no action is to be taken during childhood, as a child with an atrial septal aneurysm is not at increased risk compared with a child without one. Follow-up is scheduled on an individual basis.

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Closure of patent foramen ovale in “cryptogenic” stroke: Has the story come to an end?

International Journal of Stroke ◽

10.1177/1747493017751243 ◽

2018 ◽

Vol 13 (3) ◽

pp. 240-242 ◽

Cited By ~ 4

Author(s):

Jean-Louis Mas ◽

Gilles Chatellier

Keyword(s):

Antiplatelet Therapy ◽

Patent Foramen Ovale ◽

Oral Anticoagulants ◽

Cryptogenic Stroke ◽

Stroke Recurrence ◽

Foramen Ovale ◽

Permanent Disability ◽

Increased Risk ◽

Procedural Complications

Contrasting with three randomized trials that failed to show any superiority of patent foramen ovale closure over antithrombotic therapy, two trials recently reported lower rates of stroke recurrence among patients assigned to patent foramen ovale closure than among those assigned to antiplatelet therapy. In addition, one of the initially negative trials concluded in favor of patent foramen ovale closure after an extended follow-up period. A better selection of patients, the use of reference treatment groups that included patients who received antiplatelet therapy alone (rather than antiplatelet drugs or oral anticoagulants, according to physician preference), and a longer follow-up of patients, may explain the divergent findings across studies. Procedural complications were reported in 1.5% to 5.9% of the patients, none of which led to permanent disability or death. Patent foramen ovale closure was associated with an increased risk of new-onset atrial fibrillation in several studies and of venous thromboembolism in one study.

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Recurrence Risk in Patients with Cryptogenic Stroke, Patent Foramen Ovale, and Thrombophilia: A Systematic Review and Meta-Analysis

Thrombosis and Haemostasis ◽

10.1055/s-0039-1693739 ◽

2019 ◽

Vol 119 (11) ◽

pp. 1839-1848 ◽

Cited By ~ 4

Author(s):

Claus V. B. Hviid ◽

Claus Ziegler Simonsen ◽

Anne-Mette Hvas

Keyword(s):

Anticoagulant Therapy ◽

Patent Foramen Ovale ◽

Cryptogenic Stroke ◽

Preventive Strategy ◽

Foramen Ovale ◽

Antithrombotic Treatment ◽

Risk Of Recurrence ◽

Increased Risk ◽

Acquired Thrombophilia ◽

Pfo Closure

Objective A patent foramen ovale (PFO) is frequently associated with cryptogenic stroke in the young. Endovascular closure is superior to antithrombotic treatment in prevention of recurrence, but in the presence of a concomitant thrombophilia, the best preventive strategy is unknown. This review investigates if thrombophilia increases the risk of recurrence in patients with cryptogenic stroke and PFO and attempts to evaluate the best antithrombotic strategy after PFO closure in these patients. Methods Medline, Embase, and Web of Science were searched until April 2018. Study quality was assessed by the National Heart, Lung and Blood Institute Quality assessment tool. Odds ratio (OR) and hazard ratio for recurrence were pooled in a random effect model stratified by secondary preventive strategy. Results Eleven studies were included. Inherited or acquired thrombophilia was associated with an increased risk of recurrence (OR = 2.41, 95% confidence interval [CI]: 1.44–4.06). Looking only at patients treated with PFO closure, the risk of recurrence just lost significance (OR = 2.07, 95% CI: 0.95–4.48). The antithrombotic treatment after PFO closure was heterogeneous and recurrent events occurred in patients with both inherited and acquired thrombophilia treated by antiplatelet as well as anticoagulant therapy. Conclusion Thrombophilia is associated with an increased risk of recurrence in patients with PFO and cryptogenic stroke, which may persist after PFO closure. This suggests a need for antithrombotic therapy after PFO closure. Study heterogeneity precludes strong conclusions on antithrombotic treatment, but life-long antiplatelet therapy to patients without preexisting indication for anticoagulant therapy seems reasonable.

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Patent Foramen Ovale and Cryptogenic Stroke or Transient Ischemic Attack: To Close or Not to Close? A Systematic Review and Meta-Analysis

Cerebrovascular Diseases ◽

10.1159/000488401 ◽

2018 ◽

Vol 45 (5-6) ◽

pp. 193-203 ◽

Cited By ~ 24

Author(s):

Simona Lattanzi ◽

Francesco Brigo ◽

Claudia Cagnetti ◽

Mario Di Napoli ◽

Mauro Silvestrini

Keyword(s):

Transient Ischemic Attack ◽

Patent Foramen Ovale ◽

Cryptogenic Stroke ◽

Bleeding Complications ◽

Stroke Recurrence ◽

Foramen Ovale ◽

History Of ◽

Ischemic Attack ◽

Pfo Closure ◽

New Onset

Background: The optimal strategy of secondary stroke prevention in patients with patent foramen ovale (PFO) is controversial. This study was performed to evaluate the efficacy and safety of the device closure (DC) versus the medical therapy (MT) in patients with cryptogenic stroke or transient ischemic attack (TIA) and PFO. Summary: Randomized controlled trials with active and control groups receiving the DC plus MT and MT alone in patients with history of cryptogenic stroke/TIA and diagnosis of PFO were systematically searched. The main efficacy outcome was stroke recurrence. Subgroup-analyses were performed according to age, shunt size, and presence of atrial septal aneurysm (ASA). Safety endpoints included any serious adverse event (SAE), atrial fibrillation (AF), and major bleeding complications. Risk ratios (RRs) and hazard ratios (HRs) with 95% CIs were estimated. Five trials were included, involving 3,440 participants (DC = 1,829, MT = 1,611). There was a protective effect of closure in the risk of recurrent stroke (RR 0.43 [0.21–0.90]; p = 0.024; HR = 0.39 [0.19–0.83]; p = 0.014). The benefit of PFO closure was significant in patients with PFO associated with substantial right-to-left shunt or ASA. There were no differences in the risks of SAEs and major bleedings between the groups. The rate of new-onset AF was higher in the DC than in the MT arm (RR 4.46 [2.35–8.41]; p < 0.001). Successful device implantation and effective PFO closure were achieved in 96 and 91% of the patients respectively. Key Messages: In selected adult patients with PFO and history of cryptogenic stroke, the DC plus MT is more effective to prevent stroke recurrence and is associated with an increased risk of new-onset AF compared to the MT alone.

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Transcatheter Patent Foramen Ovale Closure Guided Only by Transesophageal Echocardiography Without fluoroscopy

10.21203/rs.2.20343/v1 ◽

2020 ◽

Author(s):

Tianli Zhao ◽

Qin Wu ◽

Hendrik Ruge ◽

Rüdiger Lange ◽

Yifeng Yang ◽

...

Keyword(s):

Adverse Events ◽

Transesophageal Echocardiography ◽

Patent Foramen Ovale ◽

Cryptogenic Stroke ◽

Foramen Ovale ◽

Clinical Experiences ◽

Serious Adverse Events ◽

Ischemic Attack ◽

Pfo Closure

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.

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