Percutaneous Patent Foramen Ovale Closure Research Articles

Abstract 4136698: Comparative Analysis of Transthoracic and Transesophageal Echocardiography for Diagnosis of High-Risk Patent Foramen Ovale

Background: Transthoracic contrast echocardiography using hand-agitated saline and provocative maneuver (cTTE) has been considered a gold standard of diagnosis of patent foramen ovale (PFO), and transesophageal echocardiography (TEE) is generally recommended for selected patients who are going to undergo percutaneous closure of PFO. Recent studies have highlighted the clinical significance and prognostic implication of various anatomical features of PFO and the adjacent atrial septum, and risk stratification using the concept of ‘a high-risk PFO (HRPFO)’ has been widely accepted. We sought to evaluate the diagnostic role of TEE with contrast study (cTEE). Methods: Clinical data from patients who underwent both cTTE and cTEE without sedation for evaluation of cryptogenic stroke was retrospectively analyzed. The bubble gradings of right-to-left shunt were classified into four groups: grade 0 (none), grade 1 (< 20), grade 2 (20-99 bubbles), and grade 3 (≧100 bubbles). HRPFO was defined as PFO with an atrial septal aneurysm or hypermobile atrial septum, or PFO with large amount of shunt (≧20 bubbles), or PFO size (distance between septum secundum and primum) of ≧2 mm. Results: From January 2017 to December 2022, a total of 572 patients underwent both cTTE and cTEE. The prevalence of PFO was 65.9 % (377 patients), and 331 patients (57.9% of the total, 87.8% of those with PFOs) were diagnosed with HRPFO using cTTE or cTEE. The prevalence of grade 2 and 3 was significantly higher in cTEE than in cTTE among proven PFO cases (68.7 % vs 75.6 %, P = 0.04). Among patients initially assessed as having a low-risk PFO or no PFO by cTTE, 22% were subsequently reclassified as having a HRPFO following cTEE. As a result, the positivity of HRPFO significantly increased from 46% to 56.8% after cTEE (P < 0.001). The sensitivity of cTTE for diagnosing a HRPFO was significantly lower than that of cTEE (79.5 % vs 98.2 %, P < 0.001). Conclusions: Diagnostic performance of cTTE can be significantly improved with the addition of cTEE without sedation. Given the beneficial effects of percutaneous closure of HRPFO, cTEE without sedation should be considered a useful screening test for patients with cryptogenic stroke.

Predictors of Residual Right to Left Shunt in Patients Undergoing Percutaneous Transcatheter Patent Foramen Ovale Closure: A New Clue “Inferior Vena Cava-Patent Foramen Ovale Angle”

Background: Many different devices are currently used for percutaneous patent foramen ovale (PFO) closure (pPFOc), aiming to achieve complete occlusion to prevent recurrent embolism. We aimed to reveal the association between residual right-to-left shunt (RLS) after pPFOc and baseline structural features of the PFO determined using transoesophageal echocardiography (TEE) before the procedure. Methods: This is a single-center cross-sectional study. A total of 123 patients who underwent pPFOc for cryptogenic stroke (CS) were screened, consecutively. Patients were compared based on the presence of residual RLS. The association of structural features of the PFO with residual RLS was evaluated using logistic regression analysis. Results: The procedure was successfully completed in a total of 103 patients included in the study after exclusion and 21% had significant residual RLS. During a median follow-up of 18 months, one patient died at 25 months due to malignancy, recurrent CS were observed in 5 (5%) patients, and atrial fibrillation was detected in 3 (3%) patients. No significant difference was observed in the baseline clinical characteristics and laboratory parameters among the patients. In addition to atrial septal aneurysm (ASA), aortic rim, tunnel width and length; inferior vena cava (IVC)-PFO tunnel angle was associated with residual RLS with a cut-off 11.3 (AUC: 0.786, 64% sensitivity, 87% specificity, p < 0.001). In individuals with residual RLS, longer and wider tunnel size, rudimentary aortic rim, acute IVC-PFO tunnel angle, and decreased tunnel length-left disc ratio were observed. Conclusions: IVC-PFO tunnel angle is a novel parameter and provides benefit to detect significant RLS in pPFOc patients.

Incidence, determinants, and impact of in-hospital complications during percutaneous patent foramen ovale closure

Abstract Introduction The incidence, types, determinants, and clinical impact of in-hospital complications after contemporary patent foramen ovale (PFO) percutaneous closure is unclear. Purpose To describe the incidence, types, determinants, and clinical impact of in-hospital complications after percutaneous PFO closure. Methods This study included consecutive patients undergoing PFO percutaneous closure for any indication in 18 centers in France and Italy from the ongoing AIR-FORCE registry. Periprocedural complications were collected, including death, bleeding, myocardial infarction (MI), supraventricular arrhythmia, pericardial effusion or tamponade, cardiac perforation, device embolization, intracardiac thrombus, venous thrombosis, atrioventricular block, brachial paraesthesia, oesophageal hematoma, and veno-arterial fistula. Determinants of periprocedural complications were evaluated using a logistic multivariate model. The clinical impact of periprocedural complications on cardiovascular events after discharge measured by the composite endpoint of death, stroke, transient ischemic attack, MI atrial arrhythmia, pulmonary embolism, deep veinous thrombosis, BARC ≥2 bleeding, or percutaneous or surgical re-intervention on the PFO) at longest follow-up was evaluated using a Cox model adjusted on age, sex, body mass index, diabetes mellitus, hypertension, dyslipidemia, and shunt severity prior to closure. Results We analyzed a total of 2,799 patients undergoing PFO closure with median age 50.7 [41.7-58.6] years and 57.9% male. A total of 109 (3.9% 95%CI 3.2%-4.7%) patients presented at least one in-hospital complication, the most frequent being supraventricular arrhythmia in 39 (1.4% 95%CI 1.0-1.9%) patients and BARC bleeding type ≥2 in 26 (0.9% 95%CI 0.6-1.4%) patients. Determinants of in-hospital complications were older age (per on year aOR 1.02 95%CI 1.01-1.04), diabetes mellitus (aOR 2.58 95%CI 1.36-4.89) and PFO closure for secondary prevention of an arterial embolic event (aOR 2.12 95%CI 1.18-3.82). With a median follow-up of 1.1 [0.3-3.1] years, the occurrence of an in-hospital complication was associated with an increased risk of cardiovascular events after discharge (aHR 1.90 95%CI 1.26-2.89) (Figure 1). Conclusions Although relatively rare, the occurrence of in-hospital complication during PFO percutaneous closure is associated with an increased risk of cardiovascular events in the year following the procedure.

Prevalence, determinants, and impact of significant shunt after percutaneous patent foramen ovale closure

Abstract Introduction Percutaneous closure of patent foramen ovale closure is increasingly performed for secondary prevention of PFO-related arterial embolic event. The clinical significance of postclosure residual right-to-left significant shunt remains unclear. Purpose To describe the prevalence, determinants, and clinical impact of a significant post-closure. Methods The AIR-FORCE is an ongoing prospective international registry of patients undergoing PFO closure from 19 centers in France, Canada and Italy. Only patients undergoing PFO for secondary prevention of an arterial embolic event with at least one available post-closure contrast transthoracic echocardiography (TTE) with agitated saline injection and Valsalva maneuvers were analyzed. Residual shunt was categorized according to the number of bubbles in the left atrial within 3 cardiac cycles at the first available contrast TTE as small (<10), moderate (10-20) or severe (> 20). Determinants of the presence of moderate or severe shunt were evaluated with multivariate logistic regression and its impact on the primary outcome (stroke, transient ischemic attack or peripheral arterial emboly) was evaluated with Cox model adjusted on age and sex. Results A total of 2413 patients, with a median age of 49.3 [40.4-57.4] years, 56% male, undergoing PFO closure between 2001 and 2023 were included. The first contrast TTE, which was performed after a median delay of 3.4 [0.9-5.8] months, reported the presence of moderate or severe residual shunt in 214 (8.9% 95%CI 7.8-10.1) patients. Determinants of the presence of moderate or severe residual shunt at the first contrast TTE were decreased body mass index (per 1kg/m², aOR 0.96 95%CI 0.93-0.99), severe shunt prior to PFO closure (aOR 3.54 95%CI 2.25-5.55) and increased device left disc diameter (per 1mm, aOR 1.08 95%CI 1.05-1.12). With a median follow-up of 2.2 [0.9-4.9] years, a total of 60 events were reported and the presence of moderate or severe residual shunt was associated with an increased risk of the primary outcome (aHR 2.46 95%CI 1.15-5.24) (Figure 1). Conclusions A moderate to severe residual right-to-left intracardiac shunt is not uncommon after PFO percutaneous closure and seems to be associated with an increased risk of arterial emboly recurrence.

Evaluation of efficacy and safety of simplified procedure for the percutaneous closure of patent foramen ovale: the Ile De France Foramen Ovale Permeable(IDFFOP) prospective, multicenter cohort study

Abstract The superiority of device closure over medical therapy for the prevention of recurrent stroke in patients with cryptogenic stroke and patent foramen ovale (PFO) was reported in several meta –analyses of randomized controlled trials. The growing number of PFO procedures requires to find alternatives to conventional guidance by transoesophageal echocardiography (TOE) needing general anesthesia. The aim of our study was to assess prospectively the efficacy and safety of a simplified procedure based on trans thoracic echocardiography (TTE) and local anesthesia rather than TOE during PFO closure. Methods Design and study oversight. The IDFFOP study was a French prospective, multicenter cohort study performed in four centers expert in TTE-guided device deployment. All patients had a stroke history, a PFO and a large or moderate right to left shunt defined by the number of microbubbles in the left atrium ( large shunt > 30, moderate : 10 to 30 microbubbles). A(Risk of Paradoxical Embolism) score>5 was required to confirm PFO imputability in stroke history. The primary end point was efficacy of TTE during the transcatheter PFO closure defined as the successful implantation of the device without malposition, without need of TOE, and absence of significant residual shunt at 3-month TTE control. Safety was defined as the absence of any periprocedural complications. Results 280 patients were enrolled from January 2018 to October 2020 ( male sex : 59.5%; Average age 57 years old ). Average ROPE score was 7; Cumulative immediate procedural success with the TTE-guided method was 99%, without any device embolization. However, in 2 patients, TOE was needed to guide device deployment. There was no severe vascular complication, or any ischaemic event during or after the procedure. 6 post-procedure groin hematomas occurred but none needed anyblood transfusion .One patient experienced a transient periprocedural atrial fibrillation. At 3 months there were only 8 (2,8%) residual right to left shunts (3 large, 5 moderate). Conclusion A simplified procedure for percutaneous PFO closure based on TTE and local anesthesia is safe and effective. Randomized controlled trials should be performed to confirm these results.

Neurologic recurrence after transcatheter PFO closure in patients with cryptogenic stroke

Abstract Background Patent foramen ovale (PFO) is associated with an increased risk of cryptogenic stroke, and interventional closure is recommended for secondary prevention. However, there is limited real-world data on long-term results. Our objective was to evaluate outcomes following successful transcatheter PFO occlusion. Methods Data from patients undergoing PFO closure for cryptogenic stroke between 2010 and 2015 were analysed to determine short- and long-term outcomes and to identify potential predictors of neurological recurrence. Results 330 patients underwent successful PFO closure. The mean age of patients was 49 (standard deviation (SD) ±12) years, and 55.5% were male. Any in-hospital adverse event was observed in eight patients (2.4%). During a median follow-up of 9.85 (SD ±2.5) years, the combined outcome of transient ischemic attack (TIA), stroke, or death from stroke was observed in 3.6% of patients (0.38 events per 100 person-years). After 5, 10, and 12 years the percentage of patients free of the composite outcome was 97.5%, 96.2%, and 96.2% respectively (Figure 1). New onset atrial fibrillation was detected in 10 patients (3.0%). A thorough analysis of the neurologic recurrences revealed a total number of six cryptogenic strokes (1.8%). Our results revealed that the Risk of Paradoxical Embolism (RoPE) score (adjHR: 0.70, 95% confidence interval [CI]: 0.52 to 0.95; p=0.022) and the number of prior neurologic events (adjHR: 9.78, 95% CI: 2.66 to 35.99; p<0.001) were strong independent predictors of future recurrent neurologic events. Kaplan Meier survival analysis stratified by number of previous neurologic events proved to be statistically significant (p<0.001; Figure 2). Conclusion In this real-world cohort of patients with cryptogenic stroke we observed excellent safety and good efficacy of percutaneous PFO closure, similar to randomized controlled trials or other long-term cohort studies. The rate of recurrent neurological events was low, especially cryptogenic strokes. The RoPE score confirmed good predictive power; in particular, the number of previous neurological events should be taken more into account when determining the indication for closure.

Anatomical classification of patent foramen ovale before percutaneous closure

Abstract Introduction Anatomical characteristics of patent foramen ovale (PFO) vary a lot, potentially impacting the embolic risk, selection of the device and the final sealing results of the closure procedure. Objective To categorize the different PFO anatomies and evaluate the consequence on the type of device used and the incidence of residual shunt. Methods 624 consecutive patients who underwent PFO percutaneous closure with transoesophageal echocardiography (TEE) guidance were retrospectively reviewed. Four types of PFO were identified once a rigid wire was in place using per-procedural TEE. This new classification was based on the PFO sheathed tunnel’s length and width, presence of concomitant atrial septal aneurysm (ASA) or additional defect (ASD), width of the septum secundum (SS) and aortic enlargement (Figure 1). Type I, or "single PFO" was defined by the absence of ASA or ASD, a tunnel width ≤ 4mm, SS’s width ≤ 10mm and no aortic enlargement (i.e., aortic root diameter <21mm/m², distorted anatomy or scoliosis). Type II or "dominant septal aneurysm" was defined by the presence of an ASA, with a distinction between subtype IIa (long PFO tunnel with length ≥10mm) and subtype IIb (short PFO tunnel with length <10mm). Type III or "modified PFO" was defined by SS’s width > 10 mm, aortic enlargement, or severe scoliosis, and type IV or "multi perforated" was defined by the presence of a concomitant ASD or a multifenestrated septal wall. In case of concomitant criteria, the predominant order was IV, then IIb, then III. For each category, the presence of residual shunt was evaluated after Valsalva manoeuvres with contrast echocardiogram 6 months after the procedure. Results Our population had a median age of 51 [41-59] years and included 43.8% women. The type II PFO was the most frequently encountered, with 42% of the patients (Table 1). A total of 44 (7.1%) patients presented multiple types concomitantly (mostly type II and III). PFO occluders were the most implanted devices overall, particularly with type I and IIb, while ASD occluder were more frequently used with types IV and IIb. Cribriform/Uni™ devices were more frequently used with type IV. Large devices (i.e., left disc’s diameter >25 mm) were predominantly used with type III and IV, but scarcely employed with type I and II. Within type II anatomies, large devices were significantly more frequently used with type IIb. Fluoroscopy duration was significantly higher with type IV. At 6 months ultrasound evaluation, large right-to-left residual shunt was significantly more frequent with type IV anatomy and with patients presenting multiple types concomitantly (18/34 - 40.9%). No significant differences were observed regarding clinical outcomes during follow-up. Conclusion Based on specific anatomical characteristics, four types of PFO may be identified, presenting with increasing procedural complexity, and requesting specific closure devices.

Comparative Effectiveness of Devices for Interventional Patent Foramen Ovale Closure: Insights from a 23-Year Monocentric Analysis.

Background/Objectives: Patent foramen ovale (PFO) is a congenital heart defect affecting up to 25% of the population, associated with an increased risk of cryptogenic stroke. Percutaneous PFO closure is a minimally invasive procedure aimed at reducing stroke risk by eliminating the right-to-left shunt. Methods: This monocentric, retrospective study analyzed 716 patients who underwent PFO closure between January 2000 and February 2023. Data collected included demographics, indications for closure, procedural details, and outcomes. Key endpoints were complications at the puncture site, pericardial effusion, recurrent stroke or transient ischemic attack (TIA), thrombi on the device, new-onset atrial fibrillation, and death. Results: The cohort had a mean age of 50.6 ± 12.6 years, with 60.8% female. Four devices were used: Occlutech PFO occluder (n = 106), Amplatzer PFO occluder (n = 227), Gore septal occluder (n = 296), and Cardia PFO-Star (n = 87). The initial procedural success rate was 98.9%, with no significant differences between devices. Complication rates were low across all devices. Residual shunt incidence decreased from 17.9% in 1 month to 3.4% in 12 months. Device-specific complications included late-onset pericardial effusion (p = 0.01), erosions (Cardia PFO-Star), and device thrombus formation (Gore septal occluder). Conclusions: PFO closure is a safe and effective method for preventing recurrent strokes, with high success rates and varying specific complication profiles, depending on the device. Further long-term studies are needed to evaluate newer devices and optimize patient outcomes.

Influence of procedural timing on the preventive yield of percutaneous patent foramen ovale closure

BackgroundThe benefit of patent foramen ovale closure (PFOC) ≤9 months after a cryptogenic stroke has been demonstrated in several randomised clinical trials. There is, however, insufficient data to support PFOC...

Comparison of Patent Foramen Ovale Sizing by Transesophageal Echocardiography and Balloon Sizing in Patients Undergoing Percutaneous Closure

BackgroundA patent foramen ovale (PFO) has a complex anatomy, and evaluating the size before closure may be challenging. We aimed to investigate the correlation between preprocedural transesophageal echocardiography (TEE) and balloon sizing of PFO in patients undergoing percutaneous PFO closure. MethodsA retrospective single-center study with analysis of 100 patients who, due to paradox thromboembolism in the left circulation, underwent percutaneous PFO closure. The PFO sizing was compared to measures attained by TEE and balloon sizing using linear regression analysis. ResultsPFO size measured by TEE occurred smaller than balloon sizing (2.19 mm [95% CI: 1.91 to 2.46] vs. 8.51 mm [95% CI: 8.02 to 9.00], p < 0.001). Additionally, neither the PFO channel length nor the atrial septal mobility measured by TEE correlated to the PFO size attained by balloon sizing, respectively (slope ?0.018 [95% CI: ?0.117 to 0.081], R = 0.036, p = 0.719) and (slope 0.049 [95% CI: ?0.043 to 0.141], R = 0.105, p = 0.297). Statistically significant difference in regression analysis but poor correlation was found between both TEE attained PFO and shunt size when compared to balloon sizing. Diverting patients according to the size of the PFO shunt was not statistically significant between PFO of moderate size compared, respectively, to a large and small PFO size. However, a difference was observed between a small and large PFO shunt size. ConclusionsPFO defect and shunt size measured by TEE showed a poor correlation with balloon sizing. Neither PFO channel length nor septal mobility were correlated to the PFO size measured by balloon sizing.

Persistence of residual shunt at 6 and 12 months after transoesophageal echocardiography-guided percutaneous closure of a patent foramen ovale for cryptogenic stroke

BackgroundYoung patients suffering from cryptogenic stroke alongside a patent foramen ovale (PFO) are often considered for percutaneous device closure to reduce the risk of stroke recurrence. Residual right-to-left shunt after...

Transcranial Doppler With Microbubbles: Screening Test to Detect and Grade Right-to-Left Shunt After an Ischemic Stroke: A Literature Review.

Right-to-left shunt, mainly due to patent foramen ovale (PFO), is likely responsible for ≈5% of all ischemic strokes and 10% of those occurring in young and middle-aged adults. Randomized clinical trials demonstrated that, in selected young and middle-aged patients with otherwise cryptogenic acute ischemic stroke and high-risk PFO, percutaneous PFO closure is more effective than antiplatelet therapy alone in preventing recurrence. However, PFO is generally a benign finding and is present in about one-quarter of the population. Therefore, in clinical practice, identifying PFOs that are likely to be pathogenetic is crucial for selecting suitable patients for PFO closure to prevent recurrent stroke and to avoid potentially harmful and costly overtreatment. Contrast transthoracic echocardiography has a relatively low sensitivity in detecting PFO, whereas transesophageal echocardiography is currently considered the gold standard for PFO detection. However, it is a relatively invasive procedure and may not always be easily feasible in the subacute setting. Contrast transcranial Doppler is a noninvasive, inexpensive, accurate tool for the detection of right-to-left shunt. We conducted a literature review on the use of contrast transcranial Doppler to detect and grade right-to-left shunt after an acute ischemic stroke and present a clinical workflow proposal for young and middle-aged patients.

Registry of Percutaneous Closure of Patent Foramen Ovale in the Secondary Prevention of Stroke.

The foramen ovale remains patent in about 25% of the adult population. In adult life, thrombi form in the venous circulation and can cross the interatrial septum and trigger an ischemic stroke - called paradoxical embolism. The treatment can be performed through percutaneous closure of the patent foramen ovale (PFO), but still rarely performed in Brazil because it is not available in the public health care. To evaluate the reproducibility of clinical trial results in real-life studies due to the low number of records published about the topic. This study is a retrospective cohort study including 121 patients who underwent percutaneous PFO closure for secondary prophylaxis of ischemic stroke between January 2012 and June 2022. We observed a mean age of 50.3 years and most females . Severe interatrial shunt was observed in 82.6% and the presence of atrial septal aneurysm in 84.2%. After 6 months of the procedure, no patient still had a residual shunt. There were no serious bleeding or vascular complications. Recurrence of a new cerebrovascular event occurred in 1.6% of patients. We observed a low recurrence of new ischemic neurological events and lack major complications related to the procedure.

Shortened Duration of Dual Anti-Platelet Therapy After Percutaneous Patent Foramen Ovale and Atrial Septal Defect Closure

Shortened Duration of Dual Anti-Platelet Therapy After Percutaneous Patent Foramen Ovale and Atrial Septal Defect Closure

Transesophageal echocardiography guidance for percutaneous closure of PFO and a new method to improve the diagnosis and safety during the procedures.

Percutaneous patent foramen ovale (PFO) closure is becoming more and more common for the treatment or prevention of PFO-associated right-to-left shunt (RLS). This study aims to investigate the value of transesophageal echocardiography (TEE) in percutaneous PFO closure, and to explore a new method that can improve intraoperative diagnosis and surgical safety. Based on our inclusion and exclusion criteria, we enrolled 73 patients between 16 and 70 years old (average age 43.25 ± 14.87 years) who underwent percutaneous PFO closure at the Department of Cardiac Surgery, Zhongshan Hospital (Xiamen), Fudan University, from January 2022 to December 2023. Out of the 73 enrolled patients, there were 28 males (38.36%) and 45 females (61.64%), 29 migraine patients (39.73%), 14 patients (19.19%) with headache and dizziness, 14 patients (19.18%) with a history of cerebral infarction (CI), and 25 patients (34.25%) with CI, lacunar infarction or ischemic focus on magnetic resonance imaging (MRI). All patients received routine transthoracic echocardiography (TTE) and agitated saline contrast echocardiography (ASCE) before operations. Percutaneous closure of PFO was completed under the guidance of TEE. In 12 patients, the method of "injection of heparinized sterile saline through the delivery sheath" was used to observe their RLS, and the anatomical characteristics of the PFO according to the shunt path were monitored and evaluated. This method was also applied to some patients to guide the conveyor to pass through the foramen ovale (FO) channel safely and effectively, thereby improving the success rate of PFO closure. The application of TEE during the procedure of percutaneous PFO closure, including preoperative evaluation, intraoperative guidance, and postoperative reevaluation, can offer further details about the anatomical and shunt characteristics of PFO, improve the diagnosis rate, and confirm the safety of the surgical path. It ensures the safety and reliability of the whole operation, greatly improving the success rate and reducing postoperative complications. TEE guidance of percutaneous PFO closure has the advantages of minimal trauma, no radiation and real-time visualization, while injecting heparinized sterile saline through the delivery sheath is safer and more effective in improving the success rate and reducing postoperative complications.

Impact of Post-Procedural Atrial Fibrillation on Anti-Thrombotic Therapy After Percutaneous Patent Foramen Ovale Closure

Impact of Post-Procedural Atrial Fibrillation on Anti-Thrombotic Therapy After Percutaneous Patent Foramen Ovale Closure

Fluoroscopy-only guided transcatheter patent foramen ovale closure: the importance of pre-procedural echocardiography.

Percutaneous closure of a patent foramen ovale (PFO) to prevent recurrent paradoxical thromboembolic events has become the standard of care. However, it remains uncertain if transesophageal echocardiography (TOE) guidance improves procedural success with an existing comprehensive pre-procedural TOE. The aim of the study was to compare the effectiveness of percutaneous PFO closure guided by fluoroscopy (FS) only vs TOE plus FS. Consecutive patients undergoing percutaneous PFO closure between February 2017 and April 2023 were analyzed. Based on pre-procedural echocardiography, patients were scheduled either for an FS-only or TOE/FS-guided procedure. The primary-endpoint was effective PFO-closure (residual-shunt grade 0/1 at 6-month follow-up). The secondary-endpoints included procedural safety/efficacy and major adverse cardiovascular events during hospital stay and at the 6-month follow-up. Two hundred-three patients (mean age 51.8 ± 12.5 years, 39.4% women, Risk of Paradoxical Embolism score = 7 [IQR = 6-7]) underwent PFO closure with FS-only guidance (88 patients, 43.3%) or TOE/FS guidance (115 patients, 56.7%). The main indications for PFO closure were cryptogenic stroke (179 patients, 88.2%) and peripheral embolism (13 patients, 6.4%). At baseline, a right-to-left shunt of grade 2 or higher was present in 199 patients (98%). The procedure time in the FS group was shorter (13 minutes in the FS group vs 16.5 minutes in the TOE/FS group, P = .002). The immediate procedural success was 99.5%. At 6 months, effective closure was achieved in 195 patients (96.1% [FS group: 97.7% vs TOE/FS group 97.8%, P = .29]). The rates of atrial fibrillation and recurrent thromboembolic events were not different among the procedural strategies (3.9% [P = .47] and 0.5% [P = .43]). After comprehensive pre-procedural echocardiography workup, PFO closure with FS guidance only seems equally safe and effective as TOE/FS guidance. A standardized pre-procedural echocardiography protocol facilitates procedural planning with excellent echocardiographic and clinical outcomes.

The Modern Clinician as an "Argonaut" Guiding Through the "Symplegades" of Evidence for PFO Closure in Patients With Migraine.

Patent foramen ovale (PFO) has been associated with migraine, especially migraine with aura, and 30-50% of individuals with migraine with aura have a PFO, suggesting it could be more than just an "innocent bystander''. Observational data showed a reduction of the frequency and severity of migraine attacks, particularly those with aura, following transcatheter PFO closure for established indications. Three small randomized controlled trials have demonstrated significant benefits of PFO closure in most of their secondary endpoints, such as reductions in the mean number of monthly migraine attacks and migraine days. Since a significant proportion of patients experience important side effects from traditional migraine medications and newer highly effective migraine prevention strategies may need to be instituted. PFO closure could in this regard to be a valuable add-on in the armamentarium of migraine treatment, improving the quality of life by alleviating the need for medications. The effect of percutaneous PFO closure on migraine treatment is needed to be clarified. As the underlying pathophysiology remains poorly understood and largely hypothetical, future investigations, focusing on the causal relationship between PFO and migraine, will help to define the subgroup of patients most likely to benefit from PFO closure. More accurate patient recruitment may lead to greater postprocedural benefits and more significant symptom improvement. Additionally, randomized controlled trials need to be reported adequately with more realistic endpoints, sufficient duration of follow-up, and statistical power to detect differences between closure and placebo groups to ensure precise and reliable findings.

The Incidence of Atrial Fibrillation After Percutaneous Patent Foramen Ovale Closure Detected by Implantable Loop Recorders

BackgroundPatent foramen ovale (PFO) is seen in 25% of the general population but in up to 50% of patients ≤60 years old with cryptogenic strokes. Trials have shown that PFO closure vs medical therapy reduces the risk of future strokes. PFO closure may cause atrial fibrillation (AF), with prior trials reporting an incidence of 2% to 11.9%. However, the true incidence of AF after PFO closure is unknown due to limitations in prior studies for long-term monitoring. MethodsThis is a retrospective observational study at a single center. Patients who underwent PFO closure and had an implantable loop recorder prior to PFO closure were included. The final review included 38 patients who had at least 2 months of implantable loop recorder data post-PFO closure. ResultsTen out of 38 (26%) patients developed AF post-PFO closure. The median time to the first episode of AF was 3.95 weeks, with 40% having their first AF episode after 3 months. Median duration of AF episodes was 1 hour. One hundred percent had spontaneous termination of AF. Of the AF patients, 70% were started on oral anticoagulant therapy. ConclusionsOur review shows a higher incidence of AF post-PFO closure as compared with most reported prior studies. We recommend larger prospective studies to explore the true incidence of AF post-PFO closure, its clinical impact, and subsequent stroke risk.

Patent Foramen Ovale Closure in Special Clinical Situations: More Questions Than Answers?

Patent foramen ovale (PFO) is a remnant of the foetal circulation resulting from incomplete occlusion of the septum primum and septum secundum. Although prevalent in about 25% of the population, it mainly remains asymptomatic. However, its clinical significance in situations such as cryptogenic stroke, migraine, and decompression illness (DCI) has been well described. Recent randomised clinical trials (RCTs) have demonstrated the efficacy of percutaneous PFO closure over pharmacological therapy alone for secondary stroke prevention in carefully selected patients. Notably, these trials have excluded older patients or those with concurrent thrombophilia. Furthermore, the role of closure in other clinical conditions associated with PFO, like decompression sickness (DCS) and migraines, remains under investigation. Our review aims to summarise the existing literature regarding epidemiology, pathophysiological mechanisms, optimal management, and closure indications for these special patient groups.