scholarly journals Incidence and delay of atrial tachycardia after patent foramen ovale closure

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
P Guedeney ◽  
J Silvain ◽  
M Hauguel-Moreau ◽  
C Sabben ◽  
S Deltour ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Medical Treatment ◽  
Patent Foramen Ovale ◽  
Atrial Tachycardia ◽  
Randomized Trials ◽  
Funding Source ◽  
Foramen Ovale ◽  
Risk Patients ◽  
Pfo Closure

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 >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 (>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

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
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.

Closing the Patent Foramen Ovale with Amplatzer Devices

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.

scholarly journals Patent foramen ovale closure versus medical therapy for stroke prevention: A systematic review and meta-analysis of randomized controlled trials

F1000Research ◽  
2017 ◽  
Vol 6 ◽  
pp. 2178
Author(s):  
Gary Tse ◽  
William K.K. Wu ◽  
Mengqi Gong ◽  
George Bazoukis ◽  
Wing Tak Wong ◽  
...  
Keyword(s):  
Systematic Review ◽  
Medical Therapy ◽  
Stroke Prevention ◽  
Patent Foramen Ovale ◽  
Randomized Trials ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Foramen Ovale ◽  
Pfo Closure

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.

scholarly journals Patent foramen ovale closure versus medical therapy for stroke prevention: A systematic review and meta-analysis of randomized controlled trials

F1000Research ◽  
2018 ◽  
Vol 6 ◽  
pp. 2178
Author(s):  
Jenny Chi Ling Lai ◽  
Gary Tse ◽  
William K.K. Wu ◽  
Mengqi Gong ◽  
George Bazoukis ◽  
...  
Keyword(s):  
Systematic Review ◽  
Medical Therapy ◽  
Stroke Prevention ◽  
Patent Foramen Ovale ◽  
Randomized Trials ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Foramen Ovale ◽  
Pfo Closure

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.

scholarly journals Patent Foramen Ovale and Closure Technique with the Amplatzer Occluder

Scientifica ◽  
2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
Bernhard Meier
Keyword(s):  
Medical Treatment ◽  
Patent Foramen Ovale ◽  
Rare Event ◽  
Paradoxical Embolism ◽  
Myocardial Infarctions ◽  
Foramen Ovale ◽  
Amplatzer Occluder ◽  
Annual Mortality ◽  
Pfo Closure

Proof that percutaneous closure of the patent foramen ovale (PFO) is superior to medical treatment is still incomplete. Paradoxical embolism is a rare event occurring over decades rather than years. None of the 4 randomized trials published carried enough patients or was followed up for long enough to reach superiority endpoints. All data, however, point to a benefit of PFO closure. Free wall erosion (exceedingly rare) and triggering of atrial fibrillation (in about 1% of patients) are the only noteworthy complications. They are outweighed by the supposedly prevented events of paradoxical embolisms, such as stroke, transient ischemic attacks, myocardial infarctions, or other systemic embolisms. Medical treatment with perhaps the exception of lifelong oral anticoagulation provides less protection. During a 10-year follow-up of a comparative study the annual mortality was significantly lower in the patients with PFO closure (0.4%) than in those with medical treatment (1.1%,P<0.03). PFO closure can be accomplished in less than 1 hour with immediate resumption of physical activity. It represents thus a kind of mechanical vaccination.

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

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
F Leclercq ◽  
X Odorico ◽  
C Arquizan ◽  
J C Macia ◽  
B Lattuca ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Adverse Outcomes ◽  
Atrial Septal Aneurysm ◽  
Foramen Ovale ◽  
Increased Risk ◽  
Pfo Closure ◽  
New Onset

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.

Patent Foramen Ovale Closure Versus Medical Therapy in Cryptogenic Strokes and Transient Ischemic Attacks: A Meta-Analysis of Randomized Trials

Angiology ◽  
2018 ◽  
Vol 70 (4) ◽  
pp. 325-331 ◽  
Author(s):  
Simone Vidale ◽  
Filippo Russo ◽  
Carlo Campana ◽  
Elio Agostoni
Keyword(s):  
Medical Treatment ◽  
Patent Foramen Ovale ◽  
Transcatheter Closure ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Transient Ischemic Attacks ◽  
Foramen Ovale ◽  
End Points ◽  
Pfo Closure ◽  
New Onset

Cryptogenic strokes account for about 25% to 40% of total ischemic strokes, and 1 of the 3 of these have a patent foramen ovale (PFO). A meta-analysis concerning the effectiveness and safety of PFO closure in cryptogenic strokes or transient ischemic attacks (TIAs) was performed. We systematically searched Medline, Embase, and the Cochrane Library through April 2018. Eligible studies were randomized clinical trials. Primary and secondary end points were, respectively, stroke or TIA and stroke recurrences. We calculated risk ratios (RRs) and 95% confidence intervals (CIs) for all end points using fixed- and random-effects meta-analyses. Data were included from 6 trials involving 3560 patients. In the pooled analysis, PFO closure was superior to medical treatment for both primary (RR: 0.39; 95% CI: 0.18-0.82; P < .02) and secondary end points (RR: 0.58; 95% CI: 0.44-0.76; P < .001). Transcatheter closure significantly increased the risk of new-onset atrial fibrillation (AF; RR: 5.74; P < .001). Percutaneous closure is superior to medical treatment in reducing stroke and TIA recurrence, even if with a significant risk increasing for new-onset AF. These findings suggest that transcatheter closure is indicated in patients with cryptogenic strokes and large PFO.

285Arrhythmias after transcatheter closure of persistent foramen ovale are related to the type and size of the implanted device

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Komar ◽  
T Przewlocki ◽  
P Prochownik ◽  
U Gancarczyk ◽  
B Sobien ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Lower Risk ◽  
Transcatheter Closure ◽  
Supraventricular Arrhythmias ◽  
Foramen Ovale ◽  
Av Conduction ◽  
Persistent Foramen Ovale ◽  
Premature Beats ◽  
Pfo Closure

Abstract Transient supraventricular arrhythmias may occur in patients following persistent foramen ovale (PFO) closure. Therefore, the aim of the study was to prospectively perform 24-hour ECG monitoring to assess the electrocardiographic effects of transcatheter closure of PFO depending on the type of implanted devices. Material and methods 351 consecutive adult subjects (196 F, 155M; mean age: 40.9±15.3) were enrolled into the study to undergo PFO closure with an Amplatzer Septal Occluder - ASO (157 pts: 117 occluders – size 25; 40 pts – size 30), and Cardia device (194 pts: 163 occluders – size 25; 31 – size 30). Holter monitoring was performed on all patients before, at 1 and 12 months after the procedure. Results The success rate of PFO closure was 97.8% (351 cases from 359 qualified in TEE), in 8 cases the PFO tunnels were too small to be forced by a catheter, in one case the PFO device caused an injury of the septum and an ASD Amplatzer device was implanted. During the procedure in 3 (0.85%) cases transient supraventricular arrhythmia and in 1 (0.28%) case bradycardia to 27 bpm occurred. At 1 month: in 7 (2%) pts changes in AV conduction occurred: 1 pt (0.28%) had complete AV dissociation, 6 (1.7%) pts intermittent first degree AV block; paroxysmal atrial fibrillation (pAF) occurred in 6 (1.7%) pts, 2 of whom had pAF prior to closure. A significant increase in the number of SVE premature beats/24h was noted at 1 month after the procedure: 1167.9±409 (27–9976) compared to baseline data 60.2±44 (0–601) (p<0.0001), at 12 months the SVE number decreased to 57.2±51 (7–752) and did not differ significantly from the baseline data. There was no change in the mean number of ventricular arrhythmias/24h after the procedure. There was a significant correlation between SVE premature beats/24h at 1 month after the procedure and device size (p<0.001 r=97211). Pts with ASO device had a significantly higher number of SVE ectopy at 1 month after PFO closure (19123.9±70) compared to pts with Cardia device (811.9±324), p<0.0001. Conclusions 1. Transcatheter closure of PFO is associated with a transient increase in supraventricular premature beats and a small risk of AV conduction abnormalities and paroxysmal atrial fibrillation in the early follow-up. There is regression of periprocedural arrhythmias after 12 months of PFO closure. 2. Transcatheter closure of PFO with Cardia device is related to a lower risk of supraventricular arrhythmias in the early follow-up. 3. The smaller device is implanted the lower risk of periprocedural arrhythmias is expected.

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

2020 ◽  
Vol 15 (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.

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 ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Patent Foramen Ovale ◽  
Percutaneous Treatment ◽  
Foramen Ovale ◽  
Transcatheter Occlusion ◽  
Occlusion Device ◽  
Contrast Enhanced ◽  
Occluder Device ◽  
Ischemic Attack

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.

Sign in / Sign up

Export Citation Format

Share Document