Percutaneous Closure of Patent Foramen Ovale – Data from Randomized Clinical Trials and Meta-Analyses

2015 ◽  
Vol 10 (1) ◽  
pp. 45 ◽  
Author(s):  
Stefan Stortecky ◽  
Stephan Windecker ◽  
◽  
Keyword(s):  
Clinical Trials ◽  
Patent Foramen Ovale ◽  
Randomized Clinical Trials ◽  
Paradoxical Embolism ◽  
Percutaneous Closure ◽  
Primary Study ◽  
Foramen Ovale ◽  
Study Results ◽  
Meta Analyses ◽  
Pfo Closure

Data from epidemiologic studies have indicated a close association between the presence of a patent foramen ovale (PFO) and cryptogenic stroke that is suggestive of paradoxical embolism as the underlying cause. Percutaneous closure of PFO has been proposed for the secondary prevention among patients suffering from paradoxical embolism. While observational data support this strategy, three randomized trials investigating percutaneous PFO closure with medical therapy have failed to detect a statistically significant reduction of the primary endpoint of recurrent ischemic cerebrovascular events, peripheral embolism, and death in the intention-to-treat analysis. Several reasons have been discussed as basis for the negative primary study results, including long recruitment rates, low number of recurrent events, and the use of different devices. In order to provide an answer to these unresolved factors, several meta-analyses have been published that have provided conflicting results. This article will review the available evidence of percutaneous PFO closure, will provide an overview on randomized clinical trials, and summarize the evidence from meta-analyses.

scholarly journals Update on the Management of Patent Foramen Ovale in 2017: Indication for Closure and Literature Review

2017 ◽  
Vol 11 (2) ◽  
pp. 75 ◽  
Author(s):  
Kimberly Atianzar ◽  
Peter Casterella ◽  
Ming Zhang ◽  
Rahul Sharma ◽  
Sameer Gafoor ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Patent Foramen Ovale ◽  
Randomized Clinical Trials ◽  
Decompression Sickness ◽  
Cryptogenic Stroke ◽  
Closure Device ◽  
Foramen Ovale ◽  
Stroke Patients ◽  
Consensus Statements ◽  
Pfo Closure

Patent foramen ovale (PFO) is a common congenital abnormality with a high prevalence of approximately 25 % in the general population and an even higher incidence of about 40 % in the cryptogenic stroke population. PFO closure in cryptogenic stroke patients as a treatment modality for the secondary prevention of recurrent stroke has been much debated and studied. Several completed randomized clinical trials sought to answer the question of whether PFO closure is beneficial for cryptogenic stroke patients. Until the most recent of these trials, no significant benefit had been demonstrated. Based on newer evidence, in October 2016 the US Food and Drug Administration approved the first dedicated closure device for PFO. This review article describes the association between PFO and cryptogenic stroke, reviews current diagnostic modalities of PFO assessment, discusses management approaches, and reviews randomized clinical trials, practice guidelines, and consensus statements. Associations between PFO and other conditions such as migraine headaches, platypnea-orthodeoxia syndrome, and decompression sickness in divers are also briefly reviewed.

scholarly journals Impact on actual clinical practice of the latest evidence for percutaneous closure of patent foramen ovale associated with stroke. A single center experience

2021 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
L Carnero Montoro ◽  
M Ruiz Ortiz ◽  
N Paredes Hurtado ◽  
M Delgado Ortega ◽  
A Rodriguez Almodovar ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Percutaneous Closure ◽  
Publication Date ◽  
Foramen Ovale ◽  
Complex Anatomy ◽  
The Mean ◽  
The Impact

Abstract Funding Acknowledgements Type of funding sources: None. Background and aims Since september 14th, 2017. Three large clinical trials demonstrated that, in selected patients, percutaneous closure of patent foramen ovale (PFO) was associated with lower recurrence in patients with cryptogenic stroke (CS). Our aim was to determine the impact of these findings on routine  clinical practice in a tertiary hospital. Methods Patients with percutaneous closure of PFO due to CS (January 2001-January 2020) were included. The clinical characteristics were analyzed individually and grouped in the RoPE score, before and after the publication date. Complex anatomy (CA) defined as interatrial septum aneurysm or basal wide bubble passage was evaluated in both periods. Results 293 patients were included. The mean age was 49 ± 11 years, 15% were older than 60 years, 60% men, 26% hypertensive, 28% smokers and 7%diabetics. The median RoPEscore was 6 [p25-75, 5-7] and 75% met CA criteria. Since september 14th, 2017, the frequency of CA and the mean age of the patients were significantly higher (89% vs. 69% p <0.0005 and 51 ± 11 vs. 48 ± 11 years, p = 0.02, respectively), and RoPEscore, significantly lower (5 [5-7] vs. 6 [5-7], p = 0.02). Conclusion The publication of clinical trials wich demonstrated the benefit of percutaneous closure of PFO in CS had a significant impact on the daily clinical practice of our institution, with an increase in indications for CA, despite a clinical profile suggestive of lower causal probability of PFO.

scholarly journals Opportunities for selective reporting of harms in randomized clinical trials: Selection criteria for nonsystematic adverse events

2019 ◽  
Author(s):  
Evan Mayo-Wilson ◽  
Nicole Fusco ◽  
Hwanhee Hong ◽  
Tianjing Li ◽  
Joseph K. Canner ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Selection Criteria ◽  
Randomized Clinical Trials ◽  
Bipolar Depression ◽  
Selective Reporting ◽  
Journal Articles ◽  
Multiple Sources ◽  
Study Results ◽  
Meta Analyses

Abstract Background: Adverse events (AEs) in randomized clinical trials may be reported in multiple sources. Different methods for reporting adverse events across trials, or across sources for a single trial, may produce inconsistent and confusing information about the adverse events associated with interventions Methods: We sought to compare the methods authors use to decide which AEs to include in a particular source (i.e., “selection criteria”) and to determine how selection criteria could impact the AEs reported. We compared sources (e.g., journal articles, clinical study reports [CSRs]) of trials for two drug-indications: gabapentin for neuropathic pain and quetiapine for bipolar depression. We identified selection criteria and assessed how criteria affected AE reporting. Results: We identified 21 gabapentin trials and 7 quetiapine trials. All CSRs (6 gabapentin, 2 quetiapine) reported all AEs without applying selection criteria; by comparison, no other source reported all AEs, and 15/68 (22%) gabapentin sources and 19/48 (40%) quetiapine sources reported using selection criteria. Selection criteria greatly affected the number of AEs that would be reported. For example, 67/316 (21%) AEs in one quetiapine trial met the criterion “occurring in ≥2% of participants in any treatment group,” while only 5/316 (2%) AEs met the criterion, “occurring in ≥10% of quetiapine-treated patients and twice as frequent in the quetiapine group as the placebo group.” Conclusions: Selection criteria for reporting AEs vary across trials and across sources for individual trials. If investigators do not pre-specify selection criteria, they might “cherry-pick” AEs based on study results. Even if investigators pre-specify selection criteria, selective reporting of AEs will produce biased meta-analyses and clinical practice guidelines. Data about all AEs identified in clinical trials should be publicly available; however, sharing data will not solve all the problems we identified in this study. Keywords: Harms, adverse events, clinical trials, reporting bias, selective outcome reporting, data sharing, trial registration

Patent Foramen Ovale Device Closure in a 27 Years Old Young Lady with Cryptogenic Ischaemic Stroke - First Case Report from Bangladesh

2021 ◽  
Vol 13 (2) ◽  
pp. 227-234
Author(s):  
AQM Reza ◽  
Aparajita Karim ◽  
Mahmood Hasan Khan ◽  
Kazi Atiqur Rahman ◽  
Md Aliuzzaman Joarder ◽  
...  
Keyword(s):  
Ischaemic Stroke ◽  
Patent Foramen Ovale ◽  
Incidental Finding ◽  
Cryptogenic Stroke ◽  
Paradoxical Embolism ◽  
Foramen Ovale ◽  
Coagulation Therapy ◽  
First Case ◽  
Treatment Paradigm ◽  
Meta Analyses

A patent foramen ovale (PFO) is highly prevalent in patients with strokes of unknown cause or cryptogenic strokes (CSs). It has been remained an unsolved question as to whether a PFO should be closed or not to prevent recurrent strokes in patients diagnosed with cryptogenic stroke (CS). A paradoxical embolism through a PFO is pointed as a leading cause of CS, especially in younger patients with low risk factors for stroke. It also remains an unsolved matter on type of anti-coagulation therapy, which would be better for patients with CS and a PFO. In addition, surgical and transcutaneous closure of a PFO has been proposed for the secondary prevention of stroke in patients with CS with PFO. Several randomized controlled trials have been conducted in recent years to test whether a PFO closure gives a significant benefit in the management of CS. Many investigators believed that a PFO was an incidental finding in patients with CS. However, meta-analyses and more recent specific trials have eliminated several confounding factors and possible biases and have also emphasized the use of a shunt closure over medical therapy in patients with CS. Therefore, these latest studies can possibly change the treatment paradigm in the near future. We are reporting a case of cryptogenic ischaemic stroke in middle cerebral artery territory due to paradoxical embolism through a PFO which was successfully closed with a device solely by a Bangladeshi Consultant & his team first time in Bangladesh. Cardiovasc. j. 2021; 13(2): 227-234

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 High-grade atrioventricular block occurring during percutaneous closure of patent foramen ovale: a case report

2020 ◽  
Vol 4 (4) ◽  
pp. 1-5
Author(s):  
Marion Kibler ◽  
Halim Marzak ◽  
Laurence Jesel ◽  
Patrick Ohlmann
Keyword(s):  
Atrioventricular Block ◽  
Patent Foramen Ovale ◽  
Atrioventricular Node ◽  
Percutaneous Closure ◽  
Right Atrial ◽  
Closure Device ◽  
High Grade ◽  
Foramen Ovale ◽  
Conduction Disturbances ◽  
Pfo Closure

Abstract Background  Percutaneous closure of patent foramen ovale (PFO) is recommended for patients presenting with PFO-related stroke. Acute high-grade conduction disturbances occurring during PFO closure procedure have not been previously reported. Case summary  We describe for the first time a case of reversible complete atrioventricular block which occurred during closure of a PFO. Discussion  We hypothesized that the block was the result of atrioventricular node compression—likely caused by the right-atrial disc of the 35-mm PFO closure device. We suggest implanting smaller devices in order to prevent atrioventricular conduction disturbances.

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