Presence Of Atrial Septal Aneurysm Research Articles

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.

Anatomical features of PFO in patients with cryptogenic stroke in comparison to autopsy results

Abstract Background In young patients suffering a stroke, well over 30% is considered cryptogenic stroke and may be associated with a PFO. The anatomical characteristics of stroke-related PFOs that allow right-to-left shunting can be assessed with TEE. The prevalence of a PFO in autopsy studies is approximately 25%, suggesting that the a priori chance of finding a possible "bystander-PFO" in young stroke victims is substantial. Purpose To assess the anatomical characteristics of PFO in patients with cryptogenic stroke and compare these with previously published results from autopsy in the general population. Methods Data on all consecutive patients that underwent PFO closure from 2016 to 2022 were collected. Anatomical PFO characteristics, including PFO diameter, tunnel length and the presence of atrial septal aneurysm, were measured with TEE during the closure procedure and analyzed by two cardiologists. Results In total 228 patients were enrolled. The mean age was 43±11 years, 116 patients (50.9%) were male, the mean RoPE-score was 7.0±1.4. The most frequent shunt grade measured with contrast bubble study during Valsalva maneuver was 3 (>25 bubbles, without opacification). Patients were divided in two groups depending on how the PFO diameter was measured, unstretched (n=119) and stretched (n=109). The mean PFO diameter was 5.4±2.6mm in the unstretched group and 10.9±3.6mm in the stretched group compared to 4.9±2.6mm in previous autopsy (p=0.192 and p<0.001, respectively). The percentage of patients with a PFO size larger than 10mm was 2% in autopsy compared to 6% in the unstretched group (p=0.109) and 52% in the stretched group (p<0.001). The mean PFO tunnel length in our combined cohort was 7.8±2.9mm. Conclusion The difference in PFO diameter found in this study indicates that PFOs found during published autopsy series, which are present in approximately 25% of the population, are significantly smaller than those related to a cryptogenic stroke. The exact prevalence of PFOs in the population that are comparable to those in cryptogenic stroke patients remains thus unknown. Future studies should define which characteristics could classify or rule out a PFO prone for associated clinical conditions, such as cryptogenic stroke.Distribution of PFO size

Machine learning in a real-world PFO study: analysis of data from multi-centers in China

PurposeThe association of patent foreman ovale (PFO) and cryptogenic stroke has been studied for years. Although device closure overall decreases the risk for recurrent stroke, treatment effects varied across different studies. In this study, we aimed to detect sub-clusters in post-closure PFO patients and identify potential predictors for adverse outcomes.MethodsWe analyzed patients with embolic stroke of undetermined sources and PFO from 7 centers in China. Machine learning and Cox regression analysis were used.ResultsUsing unsupervised hierarchical clustering on principal components, two main clusters were identified and a total of 196 patients were included. The average age was 42.7 (12.37) years and 64.80% (127/196) were female. During a median follow-up of 739 days, 12 (6.9%) adverse events happened, including 6 (3.45%) recurrent stroke, 5 (2.87%) transient ischemic attack (TIA) and one death (0.6%). Compared to cluster 1 (n = 77, 39.20%), patients in cluster 2 (n = 119, 60.71%) were more likely to be male, had higher systolic and diastolic blood pressure, higher body mass index, lower high-density lipoprotein cholesterol and increased proportion of presence of atrial septal aneurysm. Using random forest survival (RFS) analysis, eight top ranking features were selected and used for prediction model construction. As a result, the RFS model outperformed the traditional Cox regression model (C-index: 0.87 vs. 0.54).ConclusionsThere were 2 main clusters in post-closure PFO patients. Traditional cardiovascular profiles remain top ranking predictors for future recurrence of stroke or TIA. However, whether maximizing the management of these factors would provide extra benefits warrants further investigations.

Single predictor of residual right-to-left shunt to optimally select patients for suture-mediated percutaneous patent fossa ovalis closure

Abstract Background In patients with patent fossa ovalis (PFO) and paradoxical embolism, percutaneous closure of the interatrial communication has been proven more effective than medical treatment only to reduce recurrent thromboembolic events. Percutaneous suture-mediated PFO closure has been proved to be a safe and advantageous alternative to device-based PFO closure, yet its overall success rate is slightly lower in unselected patients. Hence, it is extremely important to define baseline features associated with unsatisfactory results to appropriately select patients suitable for this technique. Purpose Systematic assessment of PFO anatomy in the largest series of consecutive patients undergoing suture-mediated percutaneous PFO closure to identify a single baseline predictor of significant residual right-to-left shunt (procedural failure) for optimal selection of patient to be submitted to this procedure. Methods Pre-procedural transesophageal echocardiogram (TEE) of 302 consecutive patients (113 men, 45±12 years) who underwent percutaneous suture-mediated PFO closure at a single institution were accurately reviewed to assess a series of parameters: presence and grade of spontaneous right-to-left shunt (RLS), PFO length and width, presence of atrial septal aneurysm and its maximal bulge, and presence of an embryonic or fetal remnant (Chiari network or Eustachian valve). Results At echocardiographic follow-up (3–6 months from the closure procedure), a residual RLS ≥2 was found in 60 (19.9%) patients. At multivariable analysis, only two anatomical variables measured at pre-procedural TEE were found as independent predictors of residual RLS ≥2 at follow-up: PFO maximum width (OR 1.89, 95% CI 1.16–3.40, p=0.019) and PFO minimum length (OR 0.58, 95% CI 0.35–0.88, p=0.018). An index based on the ratio of PFO maximum width to PFO minimum septal overlapping (W/SO) was found to be the most powerful predictor of RLS ≥2 at follow-up (OR 48.1, 95% CI 9.3–352.2, p<0.001). The ROC curve for the W/SO ratio was found to have an AUC of 0.84 (95% CI 0.75–0.93) and a cut-off value of 0.61 yielding a sensitivity of 80% and specificity of 78% with a negative predictive value of 94%. Conclusions Baseline pre-procedural TEE assessment provides essential information for the selection of patients most suitable to undergo suture-mediated PFO closure. Our results indicate that the ratio between the maximum amplitude of the PFO and the minimum overlap of the septa is the optimal single baseline index to optimally select patient for an effective percutaneous PFO closure. Funding Acknowledgement Type of funding sources: None.

Study of Transesophageal Echocardiography in Young Patients with Cryptogenic Stroke: Prevalence of Patent Foramen Ovale and Interpretation of the RoPE Score.

Cryptogenic stroke (CS) is considered to be the most common stroke subtype in young patients. The Risk of Paradoxical Embolism (RoPE) score is a tool that stratifies patients with CS according to the probability of patent foramen ovale (PFO). The aim of this retrospective study is to determine the prevalence of PFO in young patients with transesophageal echocardi- ography (TEE) and to evaluate the role of RoPE score in PFO-related strokes. The medical records of patients with acute arterial ischemic stroke, who underwent TEE between 2016 and 2020, were reviewed. Patients aged 18-55 years were included in the study. Presence of PFO, PFO characteristics, presence of atrial septal aneurysm (ASA) were detected by examining the image records of the patients from the archive system. RoPE score was calculated for all patients as determined in the literature. Totally, 50 CS patients were included in the study (mean age: 39.6±9.4 years). PFO was detected in 19 (38%) patients and it was the most common cardiac abnormality in CS patients. ASA was detected in 7 (14%) patients. The mean RoPE score in patients with PFO was higher than patients without PFO, although it did not reach statistical significance (7.68±1.1 versus 6.77±1.9 P = .07). Eighteen of 19 patients with PFO had a RoPE score ≥7. In our study, PFO prevalence in the CS patients was higher than normal popula- tion. In patients with cryptogenic stroke, the RoPE score can help determine the probability of PFO related stroke and which patients should undergo TEE.

ATRIAL SEPTAL ANEURYSM IN ADULTS – IS IT A DEGENERATIVE HEART DISEASE?

Objective: Atrial septal aneurysm (ASA) is a localised “saccular” deformity of the interatrial septum, generally at the level of the fossa ovalis, which protrudes to the right or the left atrium or on both sides. It is a well recognised cardiac abnormality that was previously diagnosed on autopsy only, but it is now frequently picked up on routine echocardiography or during evaluation of ischemic stroke. There is a dearth of data on atrial septal aneurysm in our environment, and the authors set out to find the common cardiac abnormalities associated with atrial septal aneurysm in adults who had transthoracic echocardiographic examination in Enugu, South-East Nigeria Design and method: Conquest Medical Imaging is a private medical diagnostic centre in Enugu, South-East Nigeria. The centre offers radiologic and ultrasonography diagnostic services. The echocardiographic records of 1390 patients done over a 4-year period were retrospectively reviewed. The examinations were done with a Logic 500MD Echocardiographic machine made by General Electric. Data obtained from the echocardiography register included presence of atrial septal aneurysm, age, gender, other cardiac abnormalities present. Results: A total of 1174 adults had echocardiographic examination during the period under review, and consisted of 667 males and 507 females. The mean age of the males was 43.1 ± 6.2 years, while the mean age of the females was 45.9 ± 7.1 years. Atrial septal aneurysm was present in 28 patients representing 0.2% of the total adult population, and made up of 11 males and 17 females. 25 patients had one or more additional cardiac abnormalities, representing 89.3% of all patients with atrial septal aneurysm. Degenerative aortic valve disease, degenerative mitral valve disease, and left ventricular diastolic dysfunction were the cardiac abnormalities noted in addition. Conclusions: The frequent association of degenerative valvular heart diseases with atrial septal aneurysm in adults may suggest that atrial septal aneurysm has a degenerative aetiology in adults.

Anatomical predictors of residual left-to-right shunt after percutaneous suture-mediated patent fossa ovale closure

Abstract Background Percutaneous suture-mediated patent fossa ovale (PFO) closure has recently been introduced in clinical practice to overcome most of the limitations of metallic PFO occluders with early results showing a favourable efficacy and safety profile in most PFO cases. Purpose To assess PFO anatomy in a large series of patients undergoing percutaneous suture-mediated PFO closure in order to identify anatomical predictors of significant residual right-to-left shunt (RLS) and thus appropriately select patients to be submitted to this technique. Methods Pre-procedural transesophageal echocardiogram of 230 patients undergoing suture-mediated PFO closure at our Institution were carefully reviewed both qualitatively and quantitatively. The following parameters were systematically assessed in all reviewed cases: presence and grade of baseline atrial RLS, presence of bidirectional shunt, PFO length and width, presence of atrial septal aneurysm and its maximal bulge, presence and size of an embryonic or foetal remnant. Results In 37 patients a residual atrial RLS ≥2 grade was found at a mean follow-up of 248±147 days. The following variable were found to be significantly associated with significant residual atrial RLS at follow-up: grade of baseline spontaneous and Valsalva manoeuvre RLS shunt (odds ratio 2.39, 95% confidence interval 1.48–3.89, p=0.001 and odds ratio 3.07, 95% confidence interval 1.22–7.23, p=0.017), baseline bidirectional shunt across the PFO (odds ratio 3.59, 95% confidence interval 1.47–8.77, p=0.005) and PFO width (odds ratio 2.61, 95% confidence interval 1.92–3.55, p=0.001). At multivariable analysis, only PFO width ≥5 mm (odds ratio 10.97, 95% confidence interval 4.22–28.56, p=0.001) and grade of baseline RLS shunt (odds ratio 1.84, 95% confidence interval 1.05–3.21, p=0.032) were independent predictors of a significant atrial RLS at follow-up. Conclusions Suture-mediated PFO closure represents a valid alternative to traditional devices with an excellent safety and efficacy profile at follow-up. As for any new technique, it is extremely important to select the right anatomical and functional features predictive of a successful closure. The results of this study indicate that the suture-mediated closure of PFO is feasible in the majority of septal anatomies however wide PFO ≥5 mm are less likely to be closed with only one stitch. Funding Acknowledgement Type of funding source: None

Predictors of Residual Right-to-Left Shunt After Percutaneous Suture-Mediated Patent Fossa Ovalis Closure

ObjectivesThis study sought to assess patent fossa ovalis (PFO) anatomy by transesophageal echocardiography (TEE) in patients undergoing percutaneous suture-mediated PFO closure to identify predictors of post-procedural residual atrial right-to-left shunt (RLS). BackgroundPercutaneous suture-mediated PFO closure has been proven to be a safe and effective technique in most PFO patients. MethodsFrom June 2016 to October 2019, 247 consecutive patients underwent percutaneous suture-mediated PFO closure at our institution. Of them, 230 (46 ± 13 years of age, 146 women) had complete and technically evaluable pre-procedural TEE. The following parameters in short-axis view were assessed: presence and grade of spontaneous RLS, PFO length and width, presence of atrial septal aneurysm and its maximal bulge, and presence of an embryonic or fetal remnant (Chiari network or Eustachian valve). ResultsAt the first follow-up transthoracic echocardiography performed between 3 and 6 months from the closure procedure, a residual RLS ≥2 grade was found in 37 (16%) patients. Grade of pre-procedural spontaneous RLS (hazard ratio: 1.99; 95% confidence interval: 1.14 to 3.48; p = 0.016) shunt and PFO width (hazard ratio: 2.52; 95% confidence interval: 1.85 to 3.43; p < 0.001) were both found to be significantly associated with significant residual RLS at multivariable analysis. The presence of atrial septal aneurysm and its maximal bulge and of congenital remnants was not associated with significant residual RLS. ConclusionsPercutaneous suture-mediated PFO closure is feasible in the majority of septal anatomies; however, PFO >5 mm in width and spontaneous large RLS are less likely to be closed with 1 stitch only.

Residual Shunt After Patent Foramen Ovale Closure and Long-Term Stroke Recurrence: A Prospective Cohort Study.

Residual shunt is observed in up to 25% of patients after patent foramen ovale (PFO) closure, but its long-term influence on stroke recurrence currently is unknown. To investigate the association of residual shunt after PFO closure with the incidence of recurrent stroke and transient ischemic attack (TIA). Prospective cohort study comparing stroke or TIA recurrence in patients with and without residual shunt after PFO closure. Single hospital center. 1078 consecutive patients (mean age, 49.3 years) with PFO-attributable cryptogenic stroke who were undergoing percutaneous PFO closure were followed for up to 11 years. Residual shunt was evaluated by transthoracic echocardiography with saline contrast. Primary outcome was a composite of the first recurrent ischemic stroke or TIA after PFO closure. Compared with complete closure, the presence of residual shunt after PFO closure was associated with an increased incidence of recurrent stroke or TIA: 2.32 versus 0.75 events per 100 patient-years (hazard ratio [HR], 3.05 [95% CI, 1.65 to 5.62]; P < 0.001). This result remained robust after adjustment for important covariates, namely age; study period; device; presence of atrial septal aneurysm, hypertension, hyperlipidemia, diabetes, hypercoagulability, or hypermobile septum; and medication use (HR, 3.01 [CI, 1.59 to 5.69]; P < 0.001). Further stratification based on shunt size revealed that moderate or large residual shunts were associated with a higher risk for stroke or TIA recurrence (HR, 4.50 [CI, 2.20 to 9.20]; P < 0.001); the result for small residual shunts was indeterminate (HR, 2.02 [CI, 0.87 to 4.69]; P= 0.102). Nonrandomized study with potential unmeasured confounding. Among patients undergoing PFO closure to prevent future stroke, the presence of residual shunt, particularly a moderate or large residual shunt, was associated with an increased risk for stroke or TIA recurrence. National Institutes of Health.

Patent foramen ovale closure for patients with cryptogenic stroke: A systematic review and comprehensive meta-analysis of 5 randomized controlled trials and 14 observational studies.

Previous review from randomized controlled trials (RCT) showed that patients with cryptogenic stroke may benefit from patent foramen ovale (PFO) closure. However, the findings from the systematic review were not clear when observational studies were also included. We searched MEDLINE, Embase, and Cochrane databases. The primary endpoints were recurrent stroke or transient ischemic attack (TIA). The secondary outcomes were all-cause death, atrial fibrillation (AF), and hemorrhagic events. Five randomized trials and fourteen observational studies (6301 participants) were eligible. PFO closure was superior to medical therapy for stroke prevention risk ratios ([RR], 0.38; 95% CI, 0.24-0.60), but showed increased risk of AF (RR, 4.96; 95% CI, 2.31-10.7). There was no significant difference in TIA recurrence, death, and hemorrhagic events. Subgroup analyses showed that patients with factors such as substantial residual shunt, the presence of atrial septal aneurysm (ASA), male, and age <45years had a lower risk of recurrent stroke when PFOs were closed. In patients with cryptogenic stroke, PFO closure does appeared to be superior to medical therapy in stroke prevention, with an increased incidence of AF. Male, age <45years, substantial residual shunt, and the history of ASA are the factors that will predict the benefit when PFO is closed.

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

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

New Data Support Patent Foramen Ovale Closure After Stroke.

Patent foramen ovale (PFO) can be found in ≈1 of 4 adults,1 and it has been implicated as a potential source of ischemic stroke, likely via paradoxical embolization.2 The association between stroke and PFO is particularly robust among younger patients with otherwise cryptogenic stroke.3 However, the merit of percutaneous PFO closure for secondary stroke prevention has been the focus of much debate. Although the first 3 randomized trials of PFO closure did not demonstrate benefit in their primary intention-to-treat analyses, newly available data will likely change practice for many clinicians. Percutaneous catheter-based PFO closure was introduced to clinical practice in 1992.4 Subsequently, randomized clinical trials were undertaken to demonstrate efficacy of closure for secondary stroke prevention, yet enrollment was slow because many clinicians and patients were pursuing PFO closure outside the trials. Eventually, in 2012, the CLOSURE I trial5 was published, comparing medical therapy with PFO closure with the NMT Medical STARFlex device in 909 patients with PFO and cryptogenic stroke or transient ischemic attack. Patients randomized to medical therapy were given aspirin, warfarin, or both at the discretion of the enrolling investigator. The 2-year recurrent stroke rate was 2.9% after closure and 3.1% with medical therapy (hazard ratio [HR], 0.90; 95% confidence interval [CI], 0.41–1.98; P =0.79). There was no heterogeneity in the results based on the presence of atrial septal aneurysm or large shunt. Major procedural complications, atrial fibrillation, and serious adverse event rates from this and other described trials are reported in the Table. View this table: Table. Safety of Patent Foramen Ovale Closure Across All Randomized Control Trials The PC trial6 (Randomized Clinical Trial Comparing the Efficacy …

A Practical Scoring System to Select Optimally Sized Devices for Percutaneous Patent Foramen Ovale Closure.

Patent foramen ovale (PFO) has been linked to cryptogenic stroke, and closure has been reported to improve clinical outcomes. However, there are no clear guidelines to direct device sizing. This study sought to use patient characteristics and echocardiographic findings to create a prediction score for device sizing. This was a retrospective review of patients undergoing percutaneous PFO closure at our institution between July 2010 and December 2014. Demographic and clinical characteristics were recorded, and all pre- and intraprocedural echocardiography results were evaluated. Thirty-six patients underwent percutaneous PFO closure during the study period. All procedures were performed using an Amplatzer Septal Occluder "Cribriform" (ASOC) device in one of three disc diameters: 25, 30, or 35 mm. Closure was indicated for cryptogenic stroke/transient ischemic attack in 75% of cases. Every case (100%) was successful with durable shunt correction at the 6-month follow-up without complications of erosion or device embolization. The presence of atrial septal aneurysm (ASA) (p = 0.027) and PFO tunnel length >10 mm (p = 0.038) were independently associated with increased device size. A scoring system of 1 point for male sex, 1 point for ASA, and 1 point for PFO tunnel >10 mm long was associated with the size of closure device implanted (p = 0.006). A simple scoring system may be used to select an optimally sized device for percutaneous PFO closure using the ASOC device.

O113 Is Transcatheter Closure Better Than Medical Therapy For Cryptogenic Stroke With Patent Foramen Ovale? A Meta-Analysis Of Randomized Trials

Introduction: The prevalence of patent foramen ovale among patients with cryptogenic stroke is higher than that in the general population. Closure with a percutaneous device is often recommended in such patients, but it is not known whether this intervention reduces the risk of recurrent stroke. Methods: A systematic search was conducted using MEDLINE, PubMed, EMBASE, Current Contents Connect, Cochrane library, Google Scholar, Science Direct, and Web of Science. Original data were abstracted from each study and used to calculate a pooled event rate (ER), odd ratio (OR) and 95% confidence interval (95% CI). Results: Only three randomised trials comprising 2303 patients met full criteria for analysis. Procedural success (ER: 94.20%, 95% CI: 87.6–97.4%) and effective closure (ER: 92.70%, 95% CI: 85.9–96.4%) of closure therapy were good. The odds ratio for stroke (OR: 0.654, 95% CI: 0.358–1.193) and transient ischaemic attack (OR: 0.768, 95% CI: 0.413–1.429) did not confer a benefit of PFO closure over medical therapy. Age { 45 years (OR: 0.707, 95% CI: 0.27–1.856)}, gender {males (OR: 0.498, 95% CI: 0.247–1.004), females (OR: 1.16, 95% CI: 0.597–2.255)}, substantial shunt size (OR: 0.354, 95% CI: 0.089–1.406) and the presence of atrial septal aneurysm (OR: 0.7, 95% CI: 0.21–2.33) did not influence the treatment effect of PFO closure. However, the adverse events like major vascular complication (OR: 10.905, 95% CI: 1.997–59.562) and atrial fibrillation (OR: 3.297, 95% CI: 0.874–12.432) were significantly higher in the closure group. Conclusions: In patients with cryptogenic stroke or TIA who had a patent foramen ovale, closure with a device does not confer an advantage over medical therapy and is associated with adverse events like major vascular complication and atrial fibrillation. (Heart, Lung and Circulation 2013;22:903–909)

Residual shunt after percutaneous closure of patent foramen ovale with AMPLATZER occluder devices - influence of anatomic features: a transcranial Doppler and intracardiac echocardiography study

To evaluate the relationship between the anatomic features of the fossa ovalis (FO) and residual right-to-left shunt (RLS) after percutaneous patent foramen ovale (PFO) closure with AMPLATZER PFO occluder devices. FO anatomic features were assessed by intracardiac echocardiography in 127 patients with large RLS at contrast-enhanced transcranial colour Doppler (TCCD) undergoing percutaneous PFO closure with an AMPLATZER device. Residual RLS was evaluated by TCCD three and 12 months after the procedure. PFO closure was successful in all but two patients. At TCCD, a significant residual RLS (grade ≥2) was observed in 27 (21.6%) and 17 (13.6%) patients at three and 12 months, respectively. Larger baseline RLS, presence of atrial septal aneurysm, greater longitudinal and transverse FO dimensions, and use of larger devices were associated with significant residual RLS. At multivariate analysis, the presence of atrial septal aneurysm (OR 7.6; 95% CI: 1.38-42.35; p=0.02) and longitudinal FO dimension >20.8 mm (OR 8.5; 95% CI: 1.55-46.95; p=0.014) were identified as independent predictors of significant residual RLS at 12 months. Our study suggests that a large FO and the presence of atrial septal aneurysm are independent predictors of persistent residual RLS after PFO closure with AMPLATZER devices.

Patent Foramen Ovale and Infarct Volume in Cryptogenic Stroke

The causal relationship between patent foramen ovale (PFO) and stroke is controversial. We hypothesized that if PFO is a pathway of embolic source, there might be a correlation between PFO characteristics (ie, size or extent of shunt) and ischemic lesion burden (ie, infarct volume and number). From ischemic stroke patients admitted to Asan Medical Center between January 2000 and October 2007, we identified those who had (1) acute ischemic lesion on diffusion-weighted imaging within 5 days of symptom onset and (2) cryptogenic stroke and only PFO detected by transesophageal echocardiography. PFO characteristics on echocardiographic studies included size, shunt grade, shunt pattern, and the presence of atrial septal aneurysm (ASA). Enrolled were 75 patients (male, 56%; mean age, 45.3±13.9 years), including 10 patients (13.3%) with ASA. In univariable analysis, PFO size was positively correlated with log-transformed infarct volume (LIV) (regression coefficient=.469, P=.009). After adjusting for hypertension, stroke history, and migraine (all P<.2), PFO size remained independently associated with LIV (regression coefficient=.481, P=.007). Lesion number was negatively correlated with PFO size (Spearman coefficient rho=-.251, P=.03). The initial National Institutes of Health Stroke Scale scores tended to be positively correlated with PFO size (Spearman coefficient rho=.223, P=.054). In cryptogenic stroke, PFO size and ischemic lesion burden were positively correlated. These results support that PFO may play a role as a pathway of embolic source in cryptogenic stroke.

Atrial Septal Aneurysm Is Always Linked To Right-Left Shunt and Cardio embolic Risk

Atrial septal aneurysm when associated to other cardiac abnormalities, such as patent foramen ovale, Chiari network or Eustachian Membrane, is a well-known recognised risk factor for cerebral embolism. Aim of study is to assess if isolated atrial septal aneurysm could be considered statistically related to cryptogenic stroke, considering the strong clinical impact that this association could have on these patients outcome. 579 patients were investigated for a suspected patent foramen ovale using transthoracic echocardiography, in order to evaluate the presence of atrial septal aneurysm and to identify other potential cardiac embolic sources. The patients with atrial septal aneurysm underwent transcranic echodoppler and transoesophageal echocardiography examination with contrast solution during Valsalva manoeuvre.209/579 (36%) patients where we made diagnosis of atrial septal aneurysm. In this cohort of patients transcranic echodoppler showed a patent foramen ovale in 114/209 (54%), whereas transoesophageal echocardiography in 111/209 (53%); 6/114 (5%) pa-tients with a positive transcranic echodoppler had a normal transoesophageal echocardiography examination and 3/95 (3%) with normal transcranic echodoppler had a positive transoesophageal echocardiography. Transcranic echodoppler vs. transoesophageal echocardiography sensibility was 97% and specificity 94%. Only 13/98 (13%) of patients with isolated atrial septal aneurysm and 23/111 (26%) with patent foramen ovale had history of cryptogenic stroke. According to our data, isolated atrial septal aneurysm could not be considered an independent risk factor for cryptogenic stroke.

Randomized clinical trial comparing percutaneous closure of patent foramen ovale (PFO) using the Amplatzer PFO Occluder with medical treatment in patients with cryptogenic embolism (PC-Trial): rationale and design

BackgroundSeveral studies have shown an association of cryptogenic stroke and embolism with patent foramen ovale (PFO), but the question how to prevent further events in such patients is unresolved. Options include antithrombotic treatment with warfarin or antiplatelet agents or surgical or endovascular closure of the PFO. The PC-Trial was set up to compare endovascular closure and best medical treatment for prevention of recurrent events.MethodsThe PC-Trial is a randomized clinical trial comparing the efficacy of percutaneous closure of the PFO using the Amplatzer PFO occluder with best medical treatment in patients with cryptogenic embolism, i.e. mostly cryptogenic stroke. Warfarin for 6 months followed by antiplatelet agents is recommended as medical treatment. Randomization is stratified according to patients age (<45 versus ≥45 years), presence of atrial septal aneurysm (ASA yes or no) and number of embolic events before randomization (one versus more than one event). Primary endpoints are death, nonfatal stroke and peripheral embolism.Discussionpatients were randomized in 29 centers of Europe, Canada, and Australia. Randomization started February 2000. Enrollment of 414 patients was completed in February 2009. All patients will be followed-up longitudinally. Follow-up is maintained until the last enrolled patient is beyond 2.5 years of follow-up (expected in 2011).Trial RegistrationTrial listed in ClinicalTrials.gov as NCT00166257 and sponsored by AGA Medical, Plymouth, MN, USA

Risk of Recurrent Cerebrovascular Events in Patients with Cryptogenic Stroke or Transient Ischemic Attack and Patent Foramen Ovale: The FORI (Foramen Ovale Registro Italiano) Study

Background: The optimal management of patients with cryptogenic ischemic stroke found to have a patent foramen ovale (PFO) at diagnostic workup remains unclear. The aims of this observational multicenter study were to evaluate: (1) the risk of recurrent cerebrovascular events in patients with cryptogenic minor ischemic stroke or transient ischemic attack (TIA) and PFO who either underwent percutaneous PFO closure or received only medical treatment, and (2) the risk factors associated with recurrent events. Methods: Consecutive patients (aged 55 years or less) with first-ever cryptogenic minor ischemic stroke or TIA and PFO were recruited in 13 Italian hospitals between January 2006 and September 2007 and followed up for 2 years. Results: 238 patients were included in the study (mean age 42.2 ± 10.0 years; 118 males); 117 patients (49.2%) received only antithrombotic therapy while 121 patients underwent percutaneous PFO closure (50.8%). Stroke as the qualifying event was more common in the medical treatment group (p = 0.01). The presence of atrial septal aneurysm and evidence of 20 bubbles or more on transcranial Doppler were more common in the PFO closure group (p = 0.002 and 0.02). Eight patients (6.6%) experienced a nonfatal complication during PFO closure. At the 2-year follow-up, 17 recurrent events (TIA or stroke; 3.6% per year) were observed; 7 of these events (2.9% per year) occurred in the percutaneous PFO closure group and 10 events (4.2% per year) in the medical treatment group. The rate of recurrent stroke was 0.4% per year in patients who underwent percutaneous closure (1 event) and 3.4% per year in patients who received medical treatment (8 events). On multivariate analysis, percutaneous closure was not protective in preventing recurrent TIA or stroke (OR = 0.1, 95% CI = 0.02–1.5, p = 0.1), while it was barely protective in preventing recurrent stroke (OR = 0.1, 95% CI = 0.0–1.0, p = 0.053). Conclusions: The results of this observational, nonrandomized study suggest that PFO closure might be superior to medical therapy for the prevention of recurrent stroke. Periprocedural complications were the trade-off for this clinical benefit. Controlled randomized clinical trials comparing percutaneous closure with medical management are required.

The Association of Patent Foramen Ovale Morphology and Stroke Size in Patients With Paradoxical Embolism

Patent foramen ovale (PFO) has been implicated in the pathogenesis of cryptogenic stroke through paradoxical embolization to the cerebral circulation. This study evaluated the relationship between the morphological and functional size of the PFO by echocardiography compared with cerebral infarct volume identified on MRI. Patients who were referred to interventional cardiology with the diagnosis of cryptogenic stroke were included and had either a transesophageal echocardiogram or an intracardiac echo and a brain MRI at the time of stroke. Transesophageal echocardiogram or intracardiac echo was used to obtain PFO measurements. MRI of the brain with 3 sequences (T2, diffusion-weighted imaging, and fluid-attenuated inversion recovery) was used to diagnose acute stroke and measure the infarct volume. In the 72 patients studied, the median measured stroke volume was 4.3 cm(3) on diffusion-weighted imaging, 4.1 cm(3) on T2, and 3.5 cm(3) on fluid-attenuated inversion recovery. There was no significant correlation between the PFO height, length, septum secundum thickness, or echo bubble grade and the infarct volume measured from the 3 MRI sequences. There was a significant correlation between septal excursion distance and infarct volume (r=0.35; P=0.005), but the 12 patients with atrial septal aneurysm did not have the largest strokes. This analysis revealed that septal excursion distance correlates with stroke size by MRI. However, smaller PFO size without the presence of atrial septal aneurysm may still be associated with significant strokes. There was no significant association between PFO height, length by echo, or shunt grade by transcranial Doppler study and brain infarct volume. Therefore, PFO size or morphology should not be the only criteria to decide whether a PFO should be closed.