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

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.

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 (<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.

Does persistent (patent) foramen ovale closure reduce the risk of recurrent decompression sickness in scuba divers?

2021 ◽  
Vol 51 (1) ◽  
pp. 63-67
Author(s):  
Björn Edvinsson ◽  
◽  
Ulf Thilén ◽  
Niels Erik Nielsen ◽  
Christina Christersson ◽  
...  
Keyword(s):  
Patent Foramen Ovale ◽  
Decompression Sickness ◽  
Foramen Ovale ◽  
Residual Shunt ◽  
Interatrial Communication ◽  
Scuba Divers ◽  
Increased Risk ◽  
History Of ◽  
Catheter Closure ◽  
Pfo Closure

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.

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.

scholarly journals Five Year Follow-Up of Cryptogenic Stroke Patients Following Patent Foramen Ovale Closure

2021 ◽  
Vol 6 (1) ◽  
pp. 2
Author(s):  
Agnete Teivāne ◽  
Kristaps Jurjāns ◽  
Ainārs Rudzītis ◽  
Krista Lazdovska ◽  
Artūrs Balodis ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Transient Ischemic Attack ◽  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Foramen Ovale ◽  
Residual Shunt ◽  
Amplatzer Occluder ◽  
Cerebrovascular Events ◽  
Ischemic Attack ◽  
Pfo Closure

Background and Objectives: According to guidelines, patent foramen ovale (PFO) closure is recommended for secondary stroke prevention in patients with cryptogenic stroke. Paradoxial embolism from PFO-mediated right to left shunt has been described as the mechanism of stroke in these cases. The aim of the study was to determine whether PFO closure can be associated with improvement of complaints (headaches, fatigue, heart palpitations, dizziness, and visual impairment) and determine its long-term effectiveness on recurrent stroke risk reduction. Materials and Methods: A total of 103 patients were enrolled in a retrospective study and followed-up by phone up to five years after PFO closure. Standardized survey was conducted about their well-being, recurrent cerebrovascular events, and the use of prescribed medication. Patients were also followed up for residual shunts 24 h, 30 days, 1 year, and 2 years after PFO. The pathogenic ischemic stroke subtypes are determined using CCS (Causative Classification System for Ischemic Stroke). Results: Male patients accounted for 43.7% (n = 45). The mean age was—44.4 ± 13 (18–75). The most probable cause for cryptogenic stroke for 53.4% (n = 55) of patients with possible cardio-aortic embolism was PFO. Residual shunts were mostly observed in patients with Amplatzer occluder—87.5% (n = 14). There was correlation between residual shunt and increased risk of transient ischemic attack recurrence (p = 0.067). Five-years after PFO closure recurrent cerebrovascular events were reported in only 5.1% (n = 5) of patients, this difference is statistically relevant (p < 0.001). Out of 51 patients presented with complaints before PFO closure, 25.5% (n = 13) did not present with any complaints after PFO closure. Conclusions: PFO can be considered a possible risk factor for cryptogenic stroke. PFO closure is effective in reducing recurrent cerebrovascular events. Residual shunt after PFO closure increases the risk of transient ischemic attack recurrence. Amplatzer occluder device is associated with a higher risk for residual shunts after PFO closure. PFO closure can be associated with improvement of complaints.

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

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.

Abstract 4513: Efficacy And Safety Of Percutaneous Patent Foramen Ovale Closure In Patients With Thrombophilia

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Pablo Rengifo-Moreno ◽  
Ignacio Cruz-Gonzalez ◽  
Roberto J Cubeddu ◽  
Maria Sanchez-Ledezma ◽  
Mingming Ning ◽  
...  
Keyword(s):  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Rank Test ◽  
Foramen Ovale ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Cerebral Ischemic ◽  
Pfo Closure

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.

scholarly journals Safety and efficacy of endovascular patent foramen ovale closure: the first results of a Russian multicenter study

2020 ◽  
Vol 12 (6) ◽  
pp. 26-32
Author(s):  
D. V. Ognerubov ◽  
A. S. Tereshchenko ◽  
A. N. Samko ◽  
G. К. Arutyunyan ◽  
O. A. Sivakova ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Secondary Prevention ◽  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Young Patients ◽  
Paradoxical Embolism ◽  
Atrial Septal Aneurysm ◽  
Foramen Ovale ◽  
History Of ◽  
Pfo Closure

Patent foramen ovale (PFO) is detectable in more than 25% of the adult population and is generally clinically insignificant. However, it can be a cause of paradoxical embolism in some cases. Randomized trials indicate that endovascular PFO closure in patients with a history of cryptogenic stroke is an effective method for the secondary prevention of catastrophic brain damage.Objective: to study the safety and efficiency of endovascular PFO closure in young patients with a history of cryptogenic stroke.Patients and methods. Sixty-two patients, including (22 males and 40 females) women, underwent percutaneous PFO closure in May 2018 to March 2020. The patients' mean age was 37.4±7.6 years. The inclusion criteria were a prior cryptogenic ischemic stroke lasting less than 12 months and PFO with a high risk for paradoxical embolism (PFO concurrent with atrial septal aneurysm or hypermobility; PFO, ≥2 mm size; the presence of the Chiari network and/or the Eustachian valve).Results and discussion. The technical success of the operation was achieved in all cases. In 50 (80.6%) patients, the right chamber of the heart was completely isolated from the left one in the first 3 months. During the first year, the atria were also completely isolated in 10 (16.1%) patients. A left-to-right shunt persisted in 2 (3.2%) patents 12 months later. Two patients were found to have main procedural complications: one had perioperative atrial fibrillation and the other had pseudoaneurysm formation at the puncture site.Conclusion. Endovascular PFO closure is a safe and effective operation for the secondary prevention of recurrent ischemic stroke. In our study, blood shunting through the PFO was stopped in 96.6% of patients at less than 6 months after surgery, which suggests that there is a rapid and effective reduction in the risk of paradoxical embolism.

scholarly journals P772 Percutaneous transcatheter patent foramen ovale closure: does size really matter?

2020 ◽  
Vol 21 (Supplement_1) ◽  
Author(s):  
M F Ramis Barcelo ◽  
C Mas Llado ◽  
A Rodriguez ◽  
I Valadron ◽  
M Noris ◽  
...  
Keyword(s):  
Patent Foramen Ovale ◽  
Superior Vena ◽  
Cryptogenic Stroke ◽  
Vena Cava ◽  
Closure Device ◽  
Foramen Ovale ◽  
Device Closure ◽  
Residual Shunt ◽  
Device Size ◽  
Pfo Closure

Abstract Introduction Patent foramen ovale (PFO) has been associated with cryptogenic stroke. Percutaneous transcatheter PFO closure has been in development for the last years. In recent studies, it has shown a reduction of recurrent ischemic stroke events. Several manufactures of PFO device closure have developed guidelines for selection of device size based on anatomic measurements obtained through echocardiography. A study showed that according to the guidelines few patients had adequate tissue rim to allow device implantation, and yet almost all the patients had an effective closure. Purpose and methods The aim of this study was to evaluate the characteristics of PFO with transesophageal echocardiogram (TEE) (size, distance between foramen ovale-superior vena cava (FO-SVC) and distance between FO-aortic annulus (FO-AoAn)) and to determinate the correlation between the size of PFO device implanted and the theoretical device size according to the guidelines. We performed a retrospective study among patients who underwent a PFO closure procedure between 2006 and 2018. Results 42 patients were included, 55% male, mean age 56 years and mean BSA 1,83 m². The PFO mean diameter and length were 3 and 13 mm respectively. The majority of PFO were complex: 91% of patients had defects larger than 8mm and 36% had atrial septum aneurism. Characteristic of PFO were measured (Table). In older patients the distance between PFO-SVC and PFO-AoAn was larger and the septum secundum was thicker (p 0.02). The right-to-left shunt was moderated or severe in most cases (75%). The PFO closure device was successfully implanted in all patients. The majority of them received an Amplatzer PFO device (45%) followed by an Hyperion PFO device. The size of the device was 25mm in half of the patients followed by 30mm device. According to the guidelines, in 67% of the cases the wrong size was chosen and the mean size of the device should had been 30mm (SD ±5,2). TEE examination during follow up showed no residual or mild residual shunt in 80% of the patients. Residual shunt was more prevalent with larger devices (p 0.008) Conclusions These results showed that the size of PFO closure device implanted in our population differed from the size recommended by guidelines. Smaller devices have been used. According to our results, larger devices are associated with more residual shunt, which suggests that a different approach may be necessary to establish new protocols for PFO device closure Table Minimal Maximal Mean SD SVC (mm) 10 30 17.55 ±3,7 AoAn (mm) 9 23 14.1 ±3,5 Minimal and maximal distance between PFO-SVC and AoAn

scholarly journals Device closure for patent foramen ovale in patients with cryptogenic stroke: which patients should get it?

2020 ◽  
Vol 22 (Supplement_M) ◽  
pp. M43-M50
Author(s):  
Iris Parrini ◽  
Enrico Cecchi ◽  
Davide Forno ◽  
Alexander R Lyon ◽  
Riccardo Asteggiano
Keyword(s):  
Medical Therapy ◽  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Stroke Recurrence ◽  
Cardiac Complications ◽  
Atrial Septal Aneurysm ◽  
Foramen Ovale ◽  
Device Closure ◽  
Meta Analyses ◽  
Pfo Closure

Abstract Patent foramen ovale (PFO) and cryptogenic stroke (CS) both have a high prevalence. The optimal treatment to reduce stroke recurrence after CS remains controversial. Results from clinical trials, meta-analyses, and position papers, support percutaneous PFO device closure and medical therapy compared to medical therapy alone. However, the procedure may be associated with cardiac complications including an increased incidence of new atrial fibrillation. The benefit/risk balance should be determined on a case-by-case basis with the greatest benefit of PFO closure in patients with atrial septal aneurysm and PFO with large shunts. Future studies should address unsolved questions such as the choice of medical therapy in patients not undergoing closure, the duration of antiplatelet therapy, and the role of PFO closure in patients over 60 years old.

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