GORE CARDIOFORM Septal Occluder Research Articles

Same-day discharge after percutaneous closure of persistent foramen ovale using intracardiac echocardiography and the Gore Septal Occluder.

Periprocedural and postinterventional care of patients undergoing closure of patent foramen ovale (PFO) varies significantly across care providers. Same-day discharge (SDD) after transcatheter interventions is an evolving concept. This study aimed to assess the same-day discharge rate and incidence of complications in patients undergoing PFO closure with intracardiac echocardiography (ICE) using the Gore®Cardioform Septal Occluder (GSO) device. The secondary aim was to analyse the efficacy of femoral vein closure with Perclose ProGlide. Patients who underwent PFO closure with the GSO device at a university hospital in Stockholm, Sweden, were retrospectively included between March 1, 2017, and June 30, 2020, all with cryptogenic stroke as the indication for the procedure. All patients underwent PFO closure with conscious sedation and local anaesthesia. The indication for all patients was a cryptogenic stroke. Periprocedural imaging was performed using ICE and fluoroscopy in all patients. Patient characteristics and periprocedural data were collected from patient charts. Patients were kept on bed rest for 4-6 h post-intervention. Transthoracic echocardiography and clinical examination, including groin status, were performed before discharge. No clinical routine follow-up was performed the day following the intervention. Clinical follow-up was done by phone call two weeks after the procedure, and echocardiographic follow-up was done after 12 months. Data were analysed using linear and logistic regression models. In total, 262 patients were included, of which 246 (94%) had SDD. 166 patients (63%) received the ProGlide™ system for femoral vein access closure. Post-procedural arrhythmias occurred in 17 (6%) patients, and vascular complications in 9 patients (3%). The overall closure rate at follow-up was 98.5%. 25 out of 264 patients (9.5%) had to be readmitted within the first eight weeks after PFO closure, 16 due to atrial fibrillation warranting electric cardioversion, one due to an arteriovenous fistula that was operated, four due to chest pain/pain at the access site, and four patients developed fever. There was no difference in SDD among patients who received ProGlide™ vs. patients who did not receive ProGlide™. SDD appears safe after transcatheter PFO closure with the GSO device with high procedural success rates. Low rates of complications and readmissions make the intervention suitable for this patient-friendly and cost-effective concept.

Abstract 15756: To Close or Not to Close: A Case of Multisystem Immune Checkpoint Inhibitor Toxicity and PFO

Introduction: Recent emergence of immune checkpoint inhibitors (ICIs) in oncologic treatments has led to increasing research on their side effect profile. Myocarditis occurs in roughly 0.04-1.14% of patients treated with ICIs and is associated with up to 50% mortality. We present a case of multisystem ICI toxicity requiring comprehensive evaluation to ultimately reveal a PFO shunt as the cause of persistent hypoxemia. Case: A 67-year-old male with Stage IIIC cutaneous melanoma presented with non-radiating pleuritic chest pain, diplopia, dyspnea and syncope. ECG showed high grade AV block and right bundle branch block. Labs showed elevated troponin, creatinine kinase and inflammatory markers. An echocardiogram showed edematous myocardium, a small pericardial effusion, and akinetic apical/inferior septal segments. Despite diuresis, 5g of methylprednisolone, IV immunoglobulin plus mycophenolate and resolution of AV block, the patient had hypoxemia on 100% FiO2. He underwent a CTA (which ruled out PE and ICI-induced pneumonitis) and fluoroscopic sniff test (revealing bilateral moderate diaphragm paresis). A recent cardiac catheterization on prior admission showed no obstructive coronary disease. Arterial blood gas showed pO2 120 mmHg without hypercapnia on 100% FiO2. We suspected a shunt as the underlying cause and obtained a bubble study disclosing a large (> 25 bubble) PFO with right-to-left shunt. Results: Given the timing of symptoms, it was determined that pembrolizumab administration caused myocarditis and myositis with diaphragmatic paresis. In patients with pulmonary disease or diaphragmatic paresis, elevated intrathoracic and pulmonary artery pressures have been a proposed mechanism of acute worsening of right-to-left shunt resulting in hypoxemia. The patient underwent right heart catheterization and PFO closure using Gore Cardioform septal occluder with resolution of hypoxemia. A repeat echocardiogram obtained 1 month later was normal. Conclusion: All concerning clinical symptoms in the setting of ICI use require a thorough evaluation. In this case, persistent hypoxemia despite treatment for ICI toxicity unmasked a large PFO requiring closure. A multisystem approach should be used to assess suspected ICI myocarditis.

Single tertiary center experience using Gore Cardioform Atrial Septal Defect Occluder for secundum atrial septal defect closure with a focus on deficient rims.

The data on the use of Gore Cardioform Septal Occluder (GCA; W. L. Gore and Associates, Inc.) for atrial septal defect (ASD) with deficient rims is limited. All patients evaluated by transesophageal echocardiogram (TEE) for ASD occlusion were included. TEE planes at 35°, 0°, and 90° were assessed for anterior-superior (AS) and posterior (P), anterior-inferior (AI) and posterior-superior (PS), as well as superior (S) and inferior (I) rims. ASD size >20 mm, and rims less than 5 mm were defined as large and deficient, respectively. We included patients who had a procedural failure along with the patients in whom the procedure was not attempted after echocardiogram in the unsuccessful group. In 148 patients, the median weight, age, and ASD size were 36 kg (range, 8-60 kg), 11.8 years (range, 1-60 years), and 14.2 ± 8.28 mm, respectively. One or more deficient rims were noted in 112 of 148 (75.7%): 99 (67%) AS, 36 (24%) P, 17 (11%) AI, 30 (20%) PS, 26 (18%) S, and 33 (22%) I. ASD closure was performed in 115 (78%) patients. The procedure was successful in 111 (96.5%) patients with procedural failure in 4 (3.4%) patients. Multiple deficient rims were associated with reduced procedural success (OR 0.36, 95% CI, 0.25-0.56). On multivariate analysis deficient P, PS, and I rims were associated with an unsuccessful group (P = .001, .046, and .005, respectively). Complications included 1 device embolization, 1 vascular injury, and 5 arrhythmias. Transcatheter closure of ASDs with deficient rims is feasible using GCA. Large ASDs with deficient P, PS, and I rims were associated with unsuccessful closure. Risk stratification and comprehensive evaluation of ASD rims is vital for the use of GCA.

Gore Cardioform Septal Occluder

Gore Cardioform Septal Occluder

Gore Cardioform Septal Occluder

Biomedical Safety & Standards 53(7):p 53, April 15, 2023. | DOI: 10.1097/01.BMSAS.0000924608.86027.4d

378 VERY-LATE THROMBUS-RELATED STROKE AFTER PERCUTANEOUS PFO CLOSURE: MEDICAL MANAGEMENT OF A RARE COMPLICATION

Abstract In May 2020, a 45-years-old woman was admitted to the Emergency Department due to transient ischemic attack. The thrombophilia screening showed hemizygous prothrombin gene mutation (Factor II) and homozygous MTHFR mutation. The transthoracic echocardiography was normal, with a left ventricular ejection fraction of 60% and no morphological or functional valve disease. The 24-h Holter ECG and the past medical history did not show any specific cause of the neurologic manifestations. In the absence of a specific and plausible cause of the transient ischemic attack, a diagnosis of cryptogenic stroke was made. The patient then underwent transcranial Doppler, which showed a high-grade shunt (curtain effect), and transesophageal echocardiography with bubble test, which showed the presence of a massive right-to-left shunt through a patent foramen ovale (PFO) during the Valsalva maneuver. A therapy with warfarin (achieving a target INR between 2 and 3) was therefore started, and the indication for a percutaneous PFO closure was given. In January 2021 the patient underwent successful percutaneous PFO closure with the Gore Cardioform Septal Occluder 25/25 mm (W.L. Gore and Associates, Inc.) through intracardiac echocardiographic guidance with no complication and without any residual shunt. The patient was discharged on dual antiplatelet therapy with aspirin 100 mg daily plus clopidogrel 75 mg daily for six months, and pantoprazole 20 mg daily, followed by aspirin 100 mg daily chronically. After 6 months the patient underwent transcranial Doppler, which was negative for shunt. 12 months after the implantation the patient stopped aspirin by her own initiative. In August 2022, due to the diagnosis of an ovarian cyst, the gynecologist prescribed estro-progestogen pill: in that occasion, the patient did not mention her thrombophilia. After 10 days, sudden onset of weakness of the right upper limb and aphasia. The patient was then admitted to the Emergency Department, were the computer tomography showed two acute lesions on the left cerebral hemisphere. Therefore, the patient underwent intravenous thrombolysis, with complete regression of the neurological symptoms: a diagnosis of stroke was then formulated. To understand the origin of such stroke, the neurologist gave indication to cardiological evaluation. The patient did not have any palpitation in the previous months and the electrocardiogram showed normal sinus rhythm. However, the transthoracic echocardiographic evaluation showed a dubious image of a mass attached to the interatrial septum, for which the patient underwent transesophageal echocardiography, which showed a 10×9 mm fluctuating thrombus attached to the left side of the previously implanted PFO closure device. Therefore, an oral anticoagulation therapy with warfarin plus a subcutaneous therapy with enoxaparin 6000 UI twice daily (as bridge to obtain the desired INR between 2 and 3) was started. After ten days, the patient underwent a new transesophageal echocardiography, which showed a substantial reduction in the dimensions of the thrombus (4×3 mm). The patient was then discharged in warfarin therapy with no residual neurological symptoms.

Short-term electrocardiographic atrial remodelling after asd closure with the gco device in a pediatric population

Abstract Funding Acknowledgements Type of funding sources: None. Background and Aim The GORE® CARDIOFORM septal occluder (GCO) is an atrial septal defect/patent foramen ovale (ASD/PFO) closure device with theoretical advantages over other commercialized devices thanks to its softness and anatomical compliance. Our aim was to evaluate the short and medium-term electrocardiographic changes after percutaneous ASD closure with GCO in a pediatric population. Methods We enrolled 39 patients with isolated ASD submitted to trans-catheter closure with GCO from January 2020 to June 2021. EKG was performed before (T0), at 24 hours (T1) and 6 months (T2) after ASD transcatheter closure. P wave dispersion was calculated as the difference between maximum and minimum P- wave duration, PR interval as the interval between beginning of the P wave and beginning of the QRS complex and QT dispersion as the difference between maximun and minimun of QTc intervals. At 6-months from device implantation, the patients were submitted to ambulatory EKG Holter recording. Results Patients’ age and BSA were 8.2±4.2 years (IQR 4.2-8.3, median 7.0) and 1.0±0.3 m2 (IQR 0.7-1.7, median 0.9), respectively. The strectched ASD diameter was 16.3±4.5 mm (median 16), resulting in QP/QS of 1.7±0.6 (median 1.5). At the baseline mean P wave dispersion was 40±15 msec and decreased to 30±13 msec (p<0.002) at 24h, without any further change at 6 months (30±13 msec, p<0.002). PR conduction significantly improved at 24 h from device implantation (from 175.0±20.8 to 144.0±22.7 msec, p=0.018) and did not significantly change at 6 months (164.0±19.5 msec, p=NS). QTc dispersion decreased at 24 hours (31.7±.20.3, p<0.02) and at 6 months (28.0±18.1, p<0.002) from device implantation. After device deployment, 2 pts (5%) developed transient, self-limited junctional rhythm and one of them needed a short course of anti-arrhythmic therapy for supra-ventricular tachycardia. No tachy/brady-arrhythmias were recorded at the 6-months follow-up EKG Holter monitoring. Conclusions Percutaneous ASD closure with the GCO device results in significant, sudden improvement of intra-atrial, atrio-ventricular and intraventricular electrical homogeneity. This benefit persists unaltered over a medium term follow-up. It might be due to a favourable volumetric remodelling that was not hindered by mechanical impact of the occluding prosthesis and could explain the low rate of arrhythmias found at the mid-term EKG evaluation.

Patent foramen ovale closure: a comparison between two types of devices in a retrospective cohort

Abstract Background Patent foramen ovale (PFO) closure has been shown to reduce the risk of recurrent stroke in selected patients. Different PFO occluding devices have been validated by the authorities and are used in the clinical practice. Purpose The main purpose of this study is to compare the use of two types of devices for PFO closure, the GORE CARDIOFORM Septal occluder and the AMPLATZER occluders (PFO or CRIBIFORM) in terms of major clinical safety and efficacy outcomes. Methods In this single-center retrospective study, the final cohort comprised 182 patients who underwent PFO closure between January 2012 and May 2019 (mean age 57±13 years, 34% males). The population was divided in two groups according to the device used (GORE CARDIOFORM Septal occluder [n=66, 36%] or the AMPLATZER occluders [n=116, 64%]). The endpoints assessed at 6 months, were the presence of a significant shunt (at least moderate [10–25 microbubbles] at rest or during the Valsalva manoeuvre), the incidence of supraventricular arrythmias, recurrent stroke, or serious device-related adverse events. Results At 6 months, a small percentage of patients with significant residual shunt was found in both the GORE and the AMPLATZER groups (7% vs 14% respectively, p=0.182). The incidence of supraventricular arrythmias was lower in the GORE as compared to the AMPLATZER group (9.1% vs 22.4% respectively, p=0.023). During the 6-month follow-up period there were 3 ischemic strokes, all of them in the AMPLATZER group, but this difference did not reach statistical significance (p=0.188). Finally, no serious device-related adverse events were noted in the total cohort. Conclusion PFO closure with a GORE device is related to lower incidence of supraventricular arrythmias at 6 months. The presence of a significant residual shunt and the incidence of recurrent stroke were comparable between both groups. Funding Acknowledgement Type of funding sources: None.

Abstract 15398: Standing Breathless: A Case of Platypnea-Orthodeoxia Syndrome

A 67-year old women with a history of metastatic endometrial cancer, prior pulmonary embolism (PE) (on Xarelto) and mitral valve prolapse presented for 2-3 weeks of exertional dyspnea. Patient presented to oncology clinic with oxygen saturation (SpO2) in the mid-70% on room air requiring supplemental oxygen, and eventually high flow nasal cannula (HFNC). She was transferred to our cardiac intensive care unit for further management of her hypoxia. Physical exam was notable for decreasing SpO2 from supine (99%) to sitting (88%) to standing (79%). In this patient with metastatic cancer, differential diagnosis for hypoxia was broad including pneumonia, metastatic pulmonary disease, doxorubicin-induced cardiomyopathy, and PE. CT chest showed no signs of pulmonary edema, pneumonia, lung metastases, or PE. Transthoracic echocardiogram showed normal left and right ventricular function with moderate aortic regurgitation and mitral regurgitation. However, agitated saline injection showed right to left flow consistent with intraatrial shunt. Transesophageal echocardiogram confirmed large patent foramen ovale (PFO) with atrial septal aneurysm. Given physical examination findings, presence of PFO, and structural abnormalities of intraatrial septum, platypnea-orthodeoxia syndrome (POS) was considered. Right heart catheterization was completed to evaluate shunt physiology and showed unremarkable pressures (RA 1, RV 22/1, PCWP 3, PA 20/3, and LA 2). Venous oxygen saturations did not show any step-up suggesting left to right shunt. Exercise challenge did not result in any significant change in PA or PCWP pressures. Given persistent concern for POS without other clear diagnosis, patient underwent percutaneous closure of PFO with a 30mm Gore Cardioform septal occluder. Patient had resolution of her exertional hypoxia following procedure and was discharged home the next day. The case discusses 1) the importance of history of and physical exam in narrowing diagnosis, 2) utilization of multimodality imaging to evaluate intraatrial shunts, and 3) use of percutaneous methods for PFO closure.

Use of a Novel Septal Occluder Device for Left Atrial Appendage Closure in Patients With Postsurgical and Postlariat Leaks or Anatomies Unsuitable for Conventional Percutaneous Occlusion.

Interventional therapies aiming at excluding the left atrial appendage (LAA) from systemic circulation have been established as a valid alternative to oral anticoagulation in patients at high thromboembolic risk. However, their efficacy on stroke prophylaxis may be compromised owing to incomplete LAA closure. Additionally, the need for an alternative thromboembolic prevention may remain unmet in patients with contraindications to oral anticoagulation whose appendage anatomy is unsuitable for some conventional devices commercially available. We aimed at evaluating the feasibility of LAA closure with the novel Gore Cardioform Septal Occluder in patients with incomplete appendage ligation or anatomic features which do not meet the manufacturer's requirements for Watchman deployment. Twenty-one consecutive patients (mean age: 72±6 years; 85.7% males; CHA2DS2-VASc: 4.5±1.4; HAS-BLED: 3.6±1.0) were included. Transesophageal echocardiography was performed within 2 months to assess for residual LAA patency. Fourteen patients had incomplete LAA closure following surgical (n=6) or Lariat ligation (n=8). In 7 patients with an appendage anatomy unsuitable for Watchman deployment, the mean maximal landing zone size and LAA depth were 14.4±1.3 and 18.6±2.8 mm. Successful Cardioform Septal Occluder deployment was achieved in all patients. No peri-procedural complications were documented. Procedure and fluoroscopy times were 46±13 and 14±5 minutes. Follow-up transesophageal echocardiography after 58±9 days revealed complete LAA closure in all patients. Transcatheter LAA closure via a Cardioform Septal Occluder device might be a valid alternative in patients with residual leaks following failed appendage ligation or whose LAA anatomy does not meet the minimal anatomic criteria to accommodate a Watchman device. Graphic Abstract: A graphic abstract is available for this article.

Fluoroscopic and Echocardiographic Illustrations of an Unsuccessful Locking of the GORE CARDIOFORM Septal Occluder Device

Summary We illustrate an unsuccessful locking of the GORE® CARDIOFORM Septal Occluder device with an expanded right disk. We decided to leave the released device in place since there was no residual shunt at rest but a moderate shunt during Valsalva manoeuvre. The alternative would have been to snare and retrieve the device. The 6-month control showed an excellent final result.

Reversible atrioventricular block after atrial septal defect closure with a Gore Cardioform Septal Occluder

Reversible atrioventricular block after atrial septal defect closure with a Gore Cardioform Septal Occluder

Perforating the GORE® CARDIOFORM septal occluder and atrial septal defect occluder to gain access to the left atrium.

Perforate the expanded polytetrafluoroethylene membrane of the GORE® CARDIOFORM Septal Occluder (GSO) and GORE® CARDIOFORM ASD Occluder (GCA) after implantation. Percutaneous transseptal access to the left atrium is necessary for many structural and electrophysiological procedures. The potential need to access the left atrium may influence decision-making for patent foramen ovale or atrial septal defect closure. Sixteen canines underwent implantation of equal number GSO or GCA devices. A transseptal crossing procedure was performed through the device 85 (±1) days postoccluder implantation. The crossing procedure was performed utilizing commercially available equipment: radiofrequency/SureFlex sheath and standard needle/Mullin's sheath. Progressive dilation of the perforation was performed to allow passage of a 12 French Mullin's sheath into the left atrium. Left atrial access was achieved in all cases. Postmortem analysis demonstrated passage through both occluder discs in all radiofrequency/SureFlex sheath cases (4 GSO, 4 GCA) and half of the standard needle/Mullin's sheath cases (3 GSO, 1 GCA). The remaining standard needle/Mullin's sheath cases demonstrated perforation through the right atrial disc but passage around the septal aspect of the left atrial disc, thus not perforating the left atrial disc. No acute embolic complications from the procedure were observed. Left atrial access may be achieved through the GSO or GCA devices after implantation and endothelialization. The combination of a radiofrequency needle and steerable sheath provides benefit over a standard needle and Mullin's sheath in accomplishing passage through both occluder discs.

Percutaneous Closure of Patent Foramen Ovale and Secundum Atrial Septal Defects with the GORE�CARDIOFORM Septal Occluder: Incidence and Implications of Device Wire Frame Fracture

Percutaneous Closure of Patent Foramen Ovale and Secundum Atrial Septal Defects with the GORE�CARDIOFORM Septal Occluder: Incidence and Implications of Device Wire Frame Fracture

Platypnea Orthodeoxia Syndrome Secondary to Intracardiac Shunt Following Orthotopic Liver Transplantation

Platypnea orthodeoxia syndrome (POS) occurs when an upright position results in acute-onset hypoxemia and is relieved with recumbency. POS can be due to intracardiac shunting, intrapulmonary shunting, ventilation-perfusion mismatch, or a combination of these. We report a case of POS that developed 3 days post liver transplantation as a result of new-onset right to left shunting across a patent foramen ovale. Right heart catheterization revealed a posteriorly directed inferior vena cava likely due to altered inferior vena cava—right atrial junction anatomy as a result of liver transplantation. The patient underwent successful transcatheter patent foramen ovale closure with a 25-mm Gore Cardioform septal occluder device with immediate and sustained improvement in hypoxia.

Here today, gone tomorrow: Outcomes of residual leak following secundum atrial septal defect closure with the GORE CARDIOFORM Septal Occluder

To assess the outcomes and potential predictors of residual leak after implantation of the GORE CARDIOFORM Septal Occluder (GSO) in secundum atrial septal defects (ASDs). The non-self-centering design of the GSO could lead to residual leak at the edge of the device. Outcomes of residual leak are poorly understood. Retrospective, multicenter review of patients treated with the GSO for the pivotal and continued access study. Procedural, echocardiographic, and follow up data were reviewed. Multivariate analysis was performed to determine predictors of leak at implant and outcomes of these leaks. There were 370 total ASD device closures with the GSO, 65 (17.56%) of which were found to have residual leak at implantation. Patients with residual leak had larger defects (10.33 ± 3.05 mm vs. 9.13 ± 2.89 mm, p = .006) and smaller aortic rims (4.87 ± 3.33 mm vs. 6.17 ± 3.78 mm, p = .019), as compared to those without leak. Larger devices were implanted (p = .008) and more devices per case (p = .007) were utilized in the residual leak cohort as compared to those without leak. Overall, among patients with residual leak, there was a significant decrease in leak size over 1 year, from 1.55 ± 0.75 mm to 0.25 ± 0.74 mm (p < .001), with the majority (87.6%) disappearing by 12-month follow-up. Residual leak at implantation can be seen after ASD device closure with the GSO, more commonly in larger defects with smaller retroaortic rims. The vast majority of these leaks completely resolve by 1 year follow up.

Early to Mid-Term Follow-Up Outcomes of Percutaneous Closure of Atrial Septal Defects Using Recent Generation Devices: a Single-Center Experience.

Background and ObjectivesThis study aimed to describe our early to mid-term experience with transcatheter atrial septal defect (ASD) closure using the Occlutech Figulla® Flex II device (FSO), Gore® Cardioform septal occluder (GSO), and Amplatzer® septal occluder (ASO) after they were first approved in Korea in 2014, and to compare the three aforementioned kinds of ASD closure devices.MethodsBetween September 2014 and August 2016, 267 patients underwent transcatheter ASD closure in our institution. Baseline characteristics, hemodynamic features, comorbidities, and procedural success and complication rates were analyzed retrospectively. The unpaired Student t-test or variance analysis was used in the statistical analysis.ResultsThe FSO was most commonly used (n=152, 56.9%), followed by the ASO (n=98, 36.7%) and GSO (n=17, 6.4%). Baseline characteristics and hemodynamic features were similar between the devices, except that the defect size and pulmonary flow-to-systemic flow ratio were lower in the GSO group than in the other groups. Overall, the procedural success rate remained at 100%, and major complication rate was <1%. No late complication occurred during the follow-up.ConclusionsThe FSO and GSO are feasible, safe options for use in transcatheter ASD closure, and they are comparable to the ASO.

Identification of candidates for PFO closure in the echocardiography laboratory.

A patent foramen ovale (PFO) is implicated in several pathologic processes, including that of cryptogenic stroke (cCVA). Recent trials identify "high-risk" PFOs in patients with cCVA as likely to benefit from percutaneous closure. The younger the patient (<60years old) the more likely a PFO may be attributable to the cCVA. The RoPE Score index helps determine the likelihood that an existing PFO is related to a cCVA. This may help guide the clinician and patient when contemplating percutaneous PFO closure. When evaluating a patient for possible percutaneous closure, one should identify the CVA as a typical ischemic type stroke. In order to "rule-out" other causes of CVA, imaging of the intracranial arteries, cervical, and aortic arch vessels should be performed. Small vessel disease or a lacunar-type infarct should be excluded. To rule out atrial fibrillation, prolonged monitoring should be performed. An index has been developed to determine the probability that a PFO is the causative etiology and calculates the risk of recurrence. This may help guide the clinician and patient in the decision for PFO closure. In addition, one should consider a work-up for a hypercoagulable state. We will obtain an ultrasound of the lower extremities or consider deep pelvic vein thrombosis (prolonged sitting or malignancy). If the closure is to be performed, the Food and Drug Administration (FDA) has approved the Amplatzer PFO Occluder and the GORE Cardioform Septal Occluder for percutaneous closure. These devices are both approved in patients predominately between ages 18 and 60years with a cCVA due to presumed paradoxical embolism as verified by a neurologist and cardiologist and when other causes of ischemic CVA have been excluded. "High-risk" PFOs appear to achieve the most potential benefit from percutaneous closure.

Abstract 102: Consistency of Efficacy of PFO Closure in the Gore Reduce Trial

Background: The Gore REDUCE Clinical Study (REDUCE) demonstrated superiority of PFO closure in conjunction with antiplatelet therapy over antiplatelet therapy alone in reducing the risk of recurrent clinical ischemic stroke or new silent brain infarct in patients with cryptogenic stroke. Methods: We randomized 664 subjects with cryptogenic stroke at 63 multinational sites in a 2:1 ratio to either antiplatelet therapy plus PFO closure (with Gore HELEX Septal Occluder or Gore CARDIOFORM Septal Occluder) or antiplatelet therapy alone. Co-primary endpoints were freedom from recurrent clinical ischemic stroke through ≥2 years and incidence of new brain infarct (defined as the composite of clinical ischemic stroke and silent brain infarct) at 2 years. Primary analyses were performed on the intention-to-treat (ITT) population. Per-protocol (PP) analysis included only subjects randomized and treated according to critical protocol requirements (excluding those who violated key eligibility criteria, did not receive the therapy to which they were randomized, or did not comply with protocol-required medical regimen). As-treated (AT) analysis assessed all subjects based on treatment received, regardless of study assignment. Results: PFO closure was associated with a highly consistent reduction in risk compared to medical therapy alone in all three analytic cohorts (Table). Conclusions: Among selected patients with cryptogenic stroke and PFO, closure of the PFO plus antiplatelet therapy was superior to antiplatelet therapy alone for reducing the risk of subsequent ischemic stroke.

Transcatheter atrial septal defect closure in an infant (body weight 6.4\xa0kg) using the GORE CARDIOFORM septal occluder (GCSO)

IntroductionTranscatheter closure has become the treatment of choice for secundum atrial septal defects (ASD II), but particularly in small children, there is concern regarding procedure-related complications.Case descriptionWe report on a 10-month-old infant, body weight of 6.4 kg, with a large ASD who was referred for failure to thrive and dyspnea on exertion. Echocardiography showed two neighboring ASDs centrally located within an atrial septum with a length of 27 mm resulting in significant left-to-right shunting. During cardiac catheterization, hemodynamic significance of the defect as well as normal pulmonary vascular resistance was demonstrated. Balloon sizing of the central ASD showed a stretched defect diameter of 12 × 11 mm. A 20-mm GORE CARDIOFORM septal occluder (GCSO; Goremedical, W. L. Gore & Associates, Inc., Newark, DE, USA) was implanted without any complications. Initial trivial residual shunting resolved during 4 months of follow-up. Right ventricular dimensions declined significantly, and the boy gained body weight properly.Discussion, evaluation and conclusionAs demonstrated in our report, even large ASDs can be closed safely by catheter intervention in small infants. Selection of implant device and optimal sizing is of paramount importance. The size of the delivery sheath (11 French in our patient) is a potential limitation for the GCSO in smaller infants.