Patent Foramen Ovale Tunnel Research Articles

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.

The discovery of in situ thrombus attached to the patent foramen ovale channel in myocardial infarction with normal coronary arteries

Objective: Paradoxical embolism caused by a patent foramen ovale (PFO) is a rare cause of myocardial infarction (MI) in individuals presenting with normal coronary arteries on angiography; however, the deduction is often made due to the inability to identify the exact thrombus that penetrates the atrial septum. Previous studies using optical coherence tomography (OCT) have reported in situ thrombi attached to PFO tunnel in patients with cryptogenic stroke. However, the presence of such thrombi in patients with cryptogenic MI (without a definite cause) remains uncertain. Method: We retrospectively analyzed OCT data collected from February to July 2023 on PFO tunnels in MI adults with normal coronary arteries on angiography. Results: Three patients diagnosed with cryptogenic MI and a PFO underwent OCT examination. These patients exhibited varying OCT findings. White thrombi and endocardial abnormalities in the channel were observed in two patients with MI. No thrombus or anomalous morphology on the endocardial surface was noted in the third patient. PFO closure was performed on all patients, and follow-up was completed by October 1, 2023. None of the patients reported recurrence of chest pain. Conclusion: In situ thrombus was identified within the PFO channel in patients with cryptogenic MI, potentially serving as a novel etiological factor for coronary thrombosis.

Value of Intracardiac Echocardiography in the Interventional Closure of Patent Foramen Ovale with Adjacent Atrial Septal Defect

Objective. This study aimed to investigate the application value of intracardiac echocardiography (ICE) in transcatheter closure of a patent foramen ovale (PFO) combined with an adjacent atrial septal defect (ASD). Methods. This retrospective study included five patients with PFO combined with adjacent ASD who underwent transcatheter closure and were admitted to the Zhongshan Hospital of Fudan University from June to September 2023. General conditions, ultrasound and ICE findings, and operative data were recorded and followed up for 2–6 months. Results. Of the five patients, two and three had embolic stroke of undetermined source and migraine, respectively, aged 45.6 ± 12.0 years. All patients underwent successful transcatheter closure via the PFO tunnel under the guidance of ICE, without complications or new stroke, and showed significantly reduced migraine at the follow-up. Conclusion. In patients with PFO combined with adjacent ASD, closure of a PFO tunnel could be successfully achieved under ICE guidance; its clinical efficacy was accurate and worthy of promotion.

Assessment of the Characteristics of Patent Foramen Ovale Associated with Cryptogenic Stroke.

This study aims to comprehensively assess the characteristics of patent foramen ovale (PFO) in relation to Cryptogenic Strok (CS) by utilizing transesophageal echocardiography (TEE) and contrast transthoracic echocardiography (c-TTE) and to identify high-risk factors associated with PFO-related CS. Transcatheter PFO closure has demonstrated its effectiveness in preventing PFO-related CS. Therefore, understanding the specific structural attributes of PFO associated with CS is imperative. Enrollment comprised 113 test patients who experienced CS in conjunction with PFO and 117 control patients diagnosed with migraine with PFO but without a history of stroke. The characteristics of the PFO were observed by TEE and c-TTE. A comparative analysis was undertaken to assess the variations in PFO characteristics between the test patients and controls, and to uncover the independent factors relevant to CS. The patients in the test group were older than the controls. Both the height and length of the PFO during Valsalva exhibited greater dimensions in the test group when contrasted with controls. Notably, the test group presented higher incidence rates of low-angle PFO (defined as an angle between the inferior vena cava (IVC) and PFO ≤ 10°) and atrial septal aneurysm (ASA) as contrasted with the control group. Right-to-left shunt (RLS) III during Valsalva demonstrated a significantly elevated occurrence within the test group as opposed to the controls. Conversely, RLS II during Valsalva exhibited a significantly higher frequency in the controls in contrast to the tests. No significant disparities were observed between the two groups with respect to RLS I during Valsalva and all grades of RLS at rest. Multivariate analysis revealed that the length of the PFO during Valsalva, the presence of ASA, RLS III during Valsalva and low-angle PFO were independent relevant factors associated with CS. The length of the PFO tunnel, low-angle PFO, RLS III during Valsalva and the presence of ASA were independent risk factors for CS. The combined utilization of TEE and c-TTE may prove valuable in identifying PFO patients at a heightened risk of CS and in facilitating the screening process for transcatheter PFO closure.</p>.

Relationship between patent foramen ovale anatomical features and residual shunt after patent foramen ovale closure.

Transcatheter closure of patent foramen ovale (PFO) is an effective strategy for preventing recurrence of paradoxical embolism. However, PFO closure is often associated with residual shunt, which is a risk of recurrent stroke. This study aimed to evaluate the relationship between the anatomical features of PFO and residual shunt. The degree of residual shunt and its relationship with the anatomical features of PFO were evaluated in 106 patients who underwent PFO closure at our institution between March 2011 and January 2022 and in whom contrast transthoracic echocardiography was performed 1year later. The mean PFO tunnel length was 9.3 ± 3.6mm and the mean PFO height was 3.2 ± 2.2mm. Atrial septal aneurysm (ASA) was found in 37 patients. After PFO closure, residual shunt was observed in 28 patients (grade 1, n = 8; grade 2, n = 16; grade 3, n = 3; grade 4, n = 1). Univariate logistic analysis identified ASA to be associated with residual shunt (odds ratio 2.78, 95% confidence interval 1.14 to 6.79; p = 0.024). There was no association of residual shunt with the size of the PFO, the length of PFO tunnel, or the size of the device used for closure. Two of four patients with a large residual shunt of grade 3 or grade 4 were found to have device size mismatch. Residual shunt after PFO closure was observed in a quarter of patients and was related to the presence of ASA. A few patients had a large residual shunt due to the device size mismatch.

Abstract 17264: PFO Cover Index by 3D-TEE Predicts Residual Shunting After Transcatheter Closure

Introduction: Proper defect sizing and device size selection are imperative for ensuring successful clinical outcomes after transcatheter patent foramen ovale (PFO) closure. However, with current sizing techniques, residual shunting remains as high as 25% and is associated with an increased risk of recurrent neurologic events. Since 2017, we adopted a PFO sizing strategy based on right atrial (RA) tunnel “width” oversizing utilizing three-dimensional transesophageal echocardiography (3D-TEE). Hypothesis: We hypothesized that the PFO tunnel width at the RA opening and a cover index based on this dimension would predict residual shunting at long term follow-up. Methods: Sixty-four patients underwent transcatheter PFO closure (60 patients utilizing a 3D-TEE based oversizing strategy) at our institution between 2015 and 2022. PFO tunnel length, tunnel width at RA opening, and tunnel width at left atrial opening were determined by 3D-TEE either before or at the time of closure. We determined an absolute PFO “cover index” for each patient as follows: RA disc diameter - RA tunnel width. Receiver operating characteristic (ROC) curve analysis was used to determine the predictive ability of 3D-TEE derived PFO dimensions and the PFO cover index to predict residual shunting at follow-up. Results: Fifty-one of sixty-four patients had a long-term follow-up bubble study (mean follow-up time 8.0±3.7 months). Of the 47 patients closed utilizing a 3D-TEE based sizing strategy and with a follow-up bubble study, only 5 patients (10.6%) had residual shunting at follow-up. Of the three 3D-TEE based PFO dimensions, only the RA tunnel width was predictive of residual shunting at follow-up (AUC 0.84, p=0.004). A cutoff of 15.5 mm or greater for RA tunnel width had the best combination of sensitivity (86%) and specificity (73%). The PFO cover index was also strongly predictive of residual shunting at follow-up (AUC 0.87, p=0.002). A cutoff of 9.5 mm or less had the best combination of sensitivity (86%) and specificity (82%). Conclusions: A larger PFO tunnel width at the right atrial opening and a lower cover index based on this dimension predict residual shunting at follow-up. Our findings have important implications for improving sizing strategies for transcatheter PFO closure.

Clinical Performance of the Gore Septal Occluder in Patent Foramen Ovale Closure in Different Septal Anatomies: 1-Year Results from a Single-Center Experience.

PFO (Patent foramen ovale) is a common defect that affects about 25% of the population. Although its presence is asymptomatic in the majority of the cases, the remaining part becomes overt with different symptoms, including cryptogenic stroke. PFO closure is currently a widely available procedure in complex anatomy, with Amplatzer PFO Occluder (APO) being the most commonly used tool. However, the performance of another device, the GORE Septal Occluder (GSO), has not been completely explored with regard to different septal anatomies. From March 2012 to June 2020, 118 consecutive patients with an indication of PFO closure were treated using the GSO system, included in a prospective analysis, and followed. After 12 months, every patient underwent transcranial Doppler ultrasound to evaluate the effectiveness of treatment. Of 111 patients evaluated, 107 showed effective PFO closure (96.4%), and 4 showed a residual shunt (3.6%). To better evaluate the device performance, the overall population was sorted into two clusters based on the echocardiographic characteristics. The main difference between groups was for PFO width (4.85 ± 1.8 vs. 2.9 ± 1 mm, p < 0.001) and PFO tunnel length (12.6 ± 3.8 vs. 7.2 ± 2, p < 0.001), allowing complex and simple anatomies to be identified, respectively. Regardless of the aforementioned cluster, the GSO performance required to reach an effective closure was independent of anatomy type and the chosen device size. The GSO device showed a high closure rate at 1-year follow-up in patients, with at least one anatomical factor of complexity of PFO irrespective of the level of complexity itself.

Anatomical predictors for suture-based closure of the patent foramen ovale: A multicenter experience.

NobleStitch EL is a novel suture-based technique used for patent foramen ovale(PFO) closure and an alternative to traditional double-disc devices without the need for antithrombotic therapy. However, successful closure rates are still unknown, and certain anatomies may be unfavorable for successful closure. We assessed the efficacy of the NobleStitch EL and sought to identify patient-related anatomical features associated with successful suture-based closure. We included 55 patients who underwent PFO closure with the NobleStitch EL in The Netherlands and Switzerland. Successful closure was defined as residual right-to-left shunt grade ≤1 with Valsalva maneuver at a cardiac ultrasound. Predefined possible anatomical determinants for effective closure included PFO length, atrial septal aneurysm, PFO entry- and exit diameter. Successful closure was achieved in 33 patients (60%). The PFO length was shorter in patients with successful closure compared to unsuccessful closure with a median length of 9.6 mm (IQR 8.0-15.0) versus 13.3 mm (IQR 11.4-18.6) on preprocedural ultrasound (p = 0.041) and 9.9 mm (IQR 8.0-13.1) versus 12.5 mm (IQR 9.7-15.4) on angiography (p = 0.049). Additionally, the PFO exit diameter and PFO volume were smaller in patients with successful closure than unsuccessful closure, with a mean diameter of 7.0 ± 3.1 mm versus 9.5 ± 3.8 mm (p = 0.015) and a median volume of 381 mm3 (IQR 286-894) versus 985 mm3 (IQR 572-1550) (p = 0.016). In our study cohort, the successful PFO closure rate using NobleStitch EL was relatively low (60%). With this alternative procedure, patients with a small PFO driven by a short PFO tunnel length and small exit diameter seem to be eligible for successful suture-based closure.

P51 PERCUTANEOUS CLOSURE OF PATENT FORAMEN OVALE IN CHILDREN :SINGLE CENTER EXPERIENCE

Abstract Background Transcatheter patent foramen ovale (PFO) closure is a validated strategy to prevent recurrent cerebral events in adult patients; limited data are available for children. Methods This is a retrospective analysis including pediatric population underwent to percutaneous treatment of PFO in our center. Results From 2006 to 2021, 21 transcatheter PFO closures have been performed in children (mean age: 14 +3 years; female: 58%, weight: 59 + 20 kg). Indications for the closure of PFO consisted in the occurrence of cryptogenic ischemic events for 18 patients (86%), in disabling migraine symptoms for 2 patients (9,5%) and in prophylactic measure to prevent paradoxical embolism in high risk abdominal surgery for 1 patient (4,5%). Transcatheter PFO closure was performed under general anesthesia with transesophageal ultrasound guidance. Complex anatomies of PFO included atrial septal aneurysm in 4 cases (with accessory fenestration of atrial membrane in 2 of these cases) and long and stiff PFO tunnel in one case. Single device was used in 20 procedures. ASD closure device was required for 5 cases because of anatomic characteristics of PFO. In one case of large multifenestrated atrial septal aneurysm, percutaneous treatment was performed using both PFO closure device and ASD closure device. No peri and/or post procedural complications have been reported . All patients were treated with Acetylsalicylic acid and Clopidogrel for the first six months after the procedure. Conclusions Transcatheter PFO closure is a safe procedure in pediatric patients in high volume center that should be used for preventing recurrent cerebral events also in children.

Unrecognized Patent Foramen Ovale in Patient With Sinus Venosus-Type Atrial Septal Defect With Partial Anomalous Pulmonary Venous Return.

Unrecognized Patent Foramen Ovale in Patient With Sinus Venosus-Type Atrial Septal Defect With Partial Anomalous Pulmonary Venous Return.

Assessing patent foramen ovale on coronary computed tomographic angiography: a comparison with transesophageal echocardiography.

This study was undertaken to determine if coronary computed tomographic angiography (CCTA) can help to assess patent foramen ovale (PFO) with high accuracy and reproducibility when compared to transesophageal echocardiography (TEE). In total, 75 suspected PFO cases (31 men, 44 women; mean age, 45 ± 9years) were evaluated by coronary CTA and TEE. PFO tunnel length (TL) and the opening diameter of the left atrial entrance (ODLAE) and right atrial entrance (ODRAE), as well as contrast shunt (if present due to PFO), were measured by both modalities. PFO was detected in 68 patients with TEE. The sensitivity for the detection of PFO with CCTA was 85.3%; specificity, 71.4%; positive predictive value, 96.7%; and negative predictive value, 33.3%. Both modalities demonstrated good agreement in measuring TL and ODLAE of PFO. However, the ODRAE of TEE was different from that of CCTA (1.14 ± 0.4mm and 1.45 ± 0.5mm, respectively, p = 0.04). The intra-observer and inter-observer variability and agreement for TL, ODRAE, and ODLAE of PFO were excellent between the two measurements. CCTA provided a method for detection of PFO with high accuracy and reproducibility compared with TEE. Therefore, CCTA is a practical and efficient alternative to TEE for PFO diagnosis.

Endothelial Dysfunction May Link Interatrial Septal Abnormalities and MTHFR-Inherited Defects to Cryptogenic Stroke Predisposition.

We explored the significance of the L-Arginine/asymmetric dimethylarginine (L-Arg/ADMA) ratio as a biomarker of endothelial dysfunction in stroke patients. To this aim, we evaluated the correlation, in terms of severity, between the degree of endothelial dysfunction (by L-Arg/ADMA ratio), the methylene tetrahydrofolate reductase (MTHFR) genotype, and the interatrial septum (IAS) phenotype in subject with a history of stroke. Methods and Results: L-Arg, ADMA, and MTHFR genotypes were evaluated; the IAS phenotype was assessed by transesophageal echocardiography. Patients were grouped according to the severity of IAS defects and the residual enzymatic activity of MTHFR-mutated variants, and values of L-Arg/ADMA ratio were measured in each subgroup. Of 57 patients, 10 had a septum integrum (SI), 38 a patent foramen ovale (PFO), and 9 an ostium secundum (OS). The L-Arg/ADMA ratio differed across septum phenotypes (p ≤ 0.01), and was higher in SI than in PFO or OS patients (p ≤ 0.05, p ≤ 0.01, respectively). In the PFO subgroup a negative correlation was found between the L-Arg/ADMA ratio and PFO tunnel length/height ratio (p ≤ 0.05; r = − 0.37; R2 = 0.14). Interestingly, the L-Arg/ADMA ratio varied across MTHFR genotypes (p ≤ 0.0001) and was lower in subgroups carrying the most impaired enzyme with respect to patients carrying the conservative MTHFR (p ≤ 0.0001, p ≤ 0.05, respectively). Consistently, OS patients carried the most dysfunctional MTHFR genotypes, whereas SI patients the least ones. Conclusions: A low L-Arg/ADMA ratio correlates with impaired activity of MTHFR and with the jeopardized IAS phenotype along a severity spectrum encompassing OS, PFO with long/tight tunnel, PFO with short/large tunnel, and SI. This infers that genetic MTHFR defects may underlie endothelial dysfunction-related IAS abnormalities, and predispose to a cryptogenic stroke. Our findings emphasize the role of the L-Arg/ADMA ratio as a reliable marker of stroke susceptibility in carriers of IAS abnormalities, and suggest its potential use both as a diagnostic tool and as a decision aid for therapy.

Transesophageal echocardiography for incremental value of Amplatezer cribriform septal occluder for percutaneous transcatheter closure of complex septal defects: Case series

BackgroundThe anatomy of septal defects can be complex and morphologically unpredictable. Balloon sizing of such defects may not be feasible, and an appropriately sized commercial occluder may not be available. Therefore, percutaneous transcatheter closure of such defects can be challenging because of an increased risk of complications. In this study, we have described the efficacy and safety of transcatheter closure of complex septal defects using Amplatzer cribriform occluder devices, assessed by real time three-dimensional (RT 3D) color Doppler transesophageal echocardiography (TEE). Methods and ResultsFour complex septal defects were involved in this investigation: (1) reimplanted multiple atrial septal defects (ASD) with one device embolization; (2) postinfarction ventricular septal defect; (3) long tunnel patent foramen ovale; and (4) postoperative residual ASD. All patients underwent percutaneous transcatheter interventions due to the high risk of surgical complications, and one of the three available cribriform ASD device sizes (18 mm, 25 mm, or 35 mm) was implanted. Perioperative RT 3D TEE combined with fluoroscopy was used for monitoring during the procedure. All defects were successfully occluded by cribriform septal occluder devices using the transcatheter technique. ConclusionOur patients with complex septal defects were successfully treated by transcatheter closure using an Amplazter cribriform septal occluder device with careful planning based on patient presentation and close interdisciplinary collaboration. RT 3D color Doppler TEE provided precise information for the selection of the appropriate occluder device and facilitated the procedure by guiding the catheter through the often challenging patient anatomy.

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.

In-tunnel closure of patent foramen ovale with a FlatStent EF™.

Devices for percutaneous closure of patent foramen ovale (PFO) are traditionally based on two opposing discs, leaving significant surface areas exposed in the left and right atrium. The FlatStent EF™ PFO Closure System (Coherex Inc., Salt Lake City, USA) represents a major departure from these devices because it is designed to focus primarily on the PFO tunnel, leaving minimal foreign material behind. To investigate the patient selection, effectiveness, and safety of in-tunnel closure with a FlatStent EF™ in patients with PFO of ≥ 4 mm tunnel length and < 12 mm diameter at preprocedural transoesophageal echocardiography (TEE). Among 46 consecutive patients undergoing PFO closure, a FlatStent EF™ could be implanted and resulted in initial successful closure (< 5 bubbles during Valsalva manoeuvre) in 21 (46%) patients. TEE at 162 ± 40 and 317 ± 162 days after implantation demonstrated functional closure in 90% and 95% of cases, respectively. No device or air embolisation, pericardial effusion, or thrombus formation was documented. Small in-tunnel peri-device colour Doppler left to right flow was documented in 10% and 2-6 mm protrusion of FlatStent EF™ along right atrial septum without any residual flow/bubble shunting in 14%. Patients with suboptimal closure (> 5 bubbles during Valsalva manoeuvre and/or in-tunnel colour flow) had shorter tunnel on preprocedural TEE (5.3 ± 1.5 vs. 10.8 ± 3.5 mm; p = 0.003). There was no difference in TEE diameter (1.8 ± 0.5 vs. 2.0 ± 0.5 mm; p = 0.38) and stretched diameter by sizing balloon (6.3 ± 2.5 vs. 6.3 ± 1.0 mm; p = 1.00). In-tunnel PFO closure with a FlatStent EF™ represents an effective and safe option only in carefully selected patients with long tunnel (> 4 mm) regardless of the diameter if it is < 12 mm. These criteria are fulfilled in < 50% of consecutive candidates for PFO closure. The new phenomenon of in-tunnel peri-device flow and FlatStent EF™ protrusion along the right atrial septum were documented during systematic TEE follow up.

Assessment of Morphology of Patent Foramen Ovale with Transesophageal Echocardiography in Symptomatic and Asymptomatic Patients

The frequency of patent foramen ovale (PFO) is greater in patients who have had a stroke and transient ischemic attack (TIA) than that in the general population. However, it is not well defined, which PFO would cause stroke or TIA. In this trial, we aimed to evaluate whether there was a difference regarding morphologic features of PFO in patients who were symptomatic (cryptogenic stroke or history of TIA) or asymptomatic according to the neurologic findings. Symptomatic patients with PFO and cryptogenic stroke or TIA and asymptomatic patients with PFO who were symptomatic in terms of neurologic findings as well as patients without any neurologic symptoms in whom PFO was diagnosed incidentally by transesophageal echocardiography were enrolled to this retrospective study on the condition that they were aged younger than 55 years. Not only the clinical and demographic characteristics of 2 groups were compared but also their morphological features were assessed. The morphologic features of PFO that were assessed included the length and height of tunnel, atrial septal excursion distance, thickness of septum primum, and thickness of septum secundum. One hundred fifty-six patients, 64 of whom were symptomatic, were enrolled to this study. The height of PFO (median, 3.0 [interquartile range, 2.0-3.8]mm versus 2.0 [2.0-2.0]mm, P<.001), thickness of septum secundum (5.0 [5.0-7.0] versus 3.0 [2.0-3.0], P<.001), and septal excursion distance (7.0 [6.0-10.5] versus 4.0 [4.0-5.0], P<.001) were found to be greater in the symptomatic group than those in the asymptomatic group. There was no significant difference regarding the length of tunnel and thickness of septum primum. The ratio of length to height of PFO tunnel was less in the symptomatic group (3.0 [3.0-3.23] versus 5.0 [4.0-6.25], P<.001). Our findings appear to indicate that a higher PFO tunnel, relatively greater interatrial septal mobility, thicker septum pellucidum, and the presence of an atrial septal aneurysm may help identifying the subjects at the age of or younger than 55 years with PFO who are at greater risk for cryptogenic stroke or TIA.

Using the GORE® Septal Occluder (GSO) in challenging patent foramen ovale (PFO) anatomies.

We assessed efficacy and safety of the Gore(®) Septal Occluder (GSO) for patent foramen ovale (PFO) closure focusing on patients with challenging septal anatomies. In times of controversial discussion whether percutaneous PFO closure is superior to medical therapy for the prevention of recurrent embolic events after cryptogenic stroke, patient selection should mainly focus on individuals with an increased likelihood that the ischaemic event is related to the PFO. In this context, specific septal anatomies-such as the presence of an atrial septal aneurysm as well as long PFO tunnel anatomy-have been associated with a higher rate of cerebrovascular accidents. The GSO was used for PFO closure in 41 patients presenting with either atrial septal aneurysm (ASA; 27/41; 65.9%) or long PFO tunnel (> 10 mm; 32/41; 78%). Seven of these patients even presented with a tunnel length ≥ 20 mm (7/41; 17.1%). Eighteen patients had both, long-tunnel anatomy and ASA (18/41; 43.9%). The GSO was successfully implanted in all cases. No procedural complications occurred and all patients were discharged the day after the procedure. Short-term follow-up, including TEE examination, in all patients was performed 37.6 ± 9.0 days after the procedure. Mid-term follow-up was performed after 192.7 ± 45.3 days. Later complications occurred in 7.3% (2 new onset atrial fibrillation, 1 device thrombus). Only 3 patients (7.3%) had more than trace residual shunts at 6-weeks follow-up. At 6-months follow-up, the complete closure rate was 95.1% (39/41). The Gore(®) Septal Occluder is an efficient device for patent foramen ovale closure in challenging anatomies, including long-tunnel PFOs and atrial septal aneurysms.

Transseptal puncture to facilitate device closure of "long-tunnel" patent foramen ovale.

Patent foramen ovale (PFO) is common and may predispose to paradoxical embolism. Transcatheter device closure of PFO can be challenging in certain cases of "long-tunnel" PFO morphology. We report our experience with device closure of long-tunnel PFO using transseptal puncture. We retrospectively reviewed all cases of PFO device closure using transseptal puncture at the Mayo Clinic from January 1, 2010 to September 30, 2013. We arbitrarily defined a PFO tunnel configuration as a tunnel length ≥ 12 mm as observed in intracardiac echocardiography (ICE) at the time of device closure. Twelve patients (mean age 40.8 [range 15-67] years; 7 males [58%]) underwent PFO device closure with transseptal puncture. The most common indication for PFO closure was previous stroke (n = 7, 58%). Median tunnel length measured by ICE was 15 mm (12-20 mm). GORE® HELEX® Septal Occluder was used for closure in all but one patient. The only significant procedural complication was a minor perforation of the left atrial wall during attempted septal puncture, which resulted in a trivial pericardial effusion that resolved without intervention. At latest follow-up (mean 543 days, [range 170-1162]) one patient had a residual shunt and subsequently died due to complications during surgical PFO closure. No recurrent strokes or TIAs were reported. Though not without risk, transseptal puncture can be a valuable tool for facilitating device closure of long-tunnel type PFOs. GORE® HELEX® Septal Occluder may be an effective option for facilitating device closure for patients with long-tunnel type PFO.

Experience using the new GORE® septal occluder at the margins

Complex atrial anatomy continues to challenge transcatheter device closure of septal defects. Devices and technology continue to evolve. We report three cases from our institution where the new Gore Septal Occluder was utilized for the closure of a lateral tunnel fenestration, a moderate-sized secundum atrial septal defect and a long tunnel patent foramen ovale. Each case highlights the successful use of this new generation device in challenging circumstances.

The Coherex FlatStent™: an advance in patent foramen ovale closure

A patent foramen ovale (PFO) is a remnant tunnel between the right and left atrium that has been found to be present more frequently in young patients with stroke and in sufferers of migraines. Percutaneous closure of the tunnel has become commonplace, replacing surgical closure. Various devices have been developed, most of which consist of atrial discs joined by a connecting wire. The Coherex FlatStent™ provides a new paradigm for PFO closure as it consists of a nitinol frame covered with polyurethane foam that is deployed within the PFO tunnel. Animal and Phase I and II studies have shown this device to be safe, effective and easy to use. More than 100 patients have now received such a device with excellent closure rates such that it may become an attractive and important development in patients with the clinical sequelae of PFO.