CARDIOFORM Septal Occluder Research Articles

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.

Use of the GORE® CARDIOFORM Septal Occluder for percutaneous closure of secundum atrial septal defects: Results of the multicenter U.S. IDE trial.

To evaluate safety and efficacy of the GORE® CARDIOFORM Septal Occluder for percutaneous transcatheter closure of ostium secundum atrial septal defects. The GORE® CARDIOFORM septal occluder is a double-disc, low profile, soft, conformable device, with distinct advantages over the GORE® HELEX® Septal Occluder. Subjects were enrolled in this single arm prospective study from 21 U.S. sites, and followed for 3 years. Primary endpoint was 6 month composite clinical success, comprised of technical success (implantation and retention of device), closure success (normalization of right heart size), no 30 day serious adverse events, and no device embolization or reintervention. Secondary endpoints included technical success, procedure success (technical success and ≤ 2 mm residual shunt at procedure conclusion), closure success (clinically insignificant or no residual shunt), and safety (freedom from 30 day serious adverse events and 6-month device events). Between October 2012 and May 2015, 50 pivotal and 350 continued access subjects underwent attempted transcatheter GORE® CARDIOFORM Septal Occluder implantation. Median age was 6.9 years, and mean static defect diameter 9.7 ± 3.1 mm. Device placement was achieved in 93.5% (374/400). Composite clinical success was 90.2% and clinical closure success was 98.8% at 6 months. Freedom from serious adverse events was 98.3% at 30 days, with no device embolizations or reinterventions through 6 months. The GORE® CARDIOFORM Septal Occluder has high composite clinical success and safety, performing well in defects ≤17 mm by stop flow stretched diameter. Single, multifenestrated, and deficient retroaortic tissue defects were well represented and successfully treated.

ASSURED clinical study: New GORE® CARDIOFORM ASD occluder for transcatheter closure of atrial septal defect

Assess clinical performance of a new device for transcatheter closure of atrial septal defect (ASD). Previously-approved ASD Closure devices have known limitations. Device erosion has been associated with the AMPLATZER® septal occluder in patients with retro-aortic rim deficiency (<5 mm), while defects ≥18 mm are too large for the GORE® CARDIOFORM septal occluder. The GORE® CARDIOFORM ASD occluder (GCA), a hybrid of the approved devices, was designed to expand the eligible ASD population. One-hundred and twenty-five ASD patients were enrolled in a prospective, multicenter registry. Descriptive clinical endpoints included: technical implant success, closure success, serious adverse events (SAE), clinically significant new arrhythmia, and wire frame fracture. Procedural outcomes and adverse events were adjudicated by an Echocardiography Core Lab and Independent Data Review Board, respectively. Median subject age was 12.3 years (range 2.9-84.7), with 72% of patients ≤18 years old. Median ASD stop-flow diameter was 17.0 mm (8.0-30.0), with 43% ≥18 mm. Deficient retro-aortic rim occurred in 57% of subjects, and 30% had both diameter ≥ 18 mm and deficient rim. Technical Implant Success was achieved in 120/125 (96%), though three devices were removed within 24 hr. At the scheduled 6-month evaluation, 112/117 returned for evaluation. All 112 had closure success. SAE occurred in 6/125 (4.8%) and 6/125 (4.8%) had clinically significant new arrhythmia. Wire frame fractures occurred in 37/104 (36%), without any associated clinical sequelae, residual shunt, or device instability. The GCA performed effectively and safely in this initial cohort, and led to FDA approval based on this data.

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.

GORE® CARDIOFORM Septal Occluder Migraine Clinical Study: A Study to Evaluate the Safety and Efficacy of Transcatheter Closure of Patent Foramen Ovale for Relief of Migraine Headaches

GORE® CARDIOFORM Septal Occluder Migraine Clinical Study: A Study to Evaluate the Safety and Efficacy of Transcatheter Closure of Patent Foramen Ovale for Relief of Migraine Headaches

Acute Ballooning of a Cardioform Septal Occluder During Percutaneous Closure of an Iatrogenic Atrial Septal Defect

A 48-year-old male underwent elective pulmonary vein Cryoablation for symptomatic persistent atrial fibrillation. Transseptal puncture was performed with a brockenbrough-1 needle and a Mullins shea...

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.

Porous CARDIOFORM Septal Occluder Balloons Within the Right Atrial Cavity

A 68-year-old woman presented with fatigue, atrial fibrillation, and tachy-brady syndrome requiring a pacemaker. Transesophageal echocardiography revealed an 8-mm secundum atrial septal defect with shunt fraction (Qp/Qs) of 2.7 ([Figure 1A][1], [Online Video 1][2]). Atrial septal defect closure was

The Case for Selective Patent Foramen Ovale Closure After Cryptogenic Stroke.

Controversy has persisted for over a decade whether transcatheter patent foramen ovale (PFO) closure reduces the rate of recurrent ischemic stroke for patients who have had a cryptogenic ischemic stroke and have a PFO. In September 2017, 3 positive randomized trials: RESPECT long-term (Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment trial), REDUCE (GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging-Confirmed TIA in Patients With Patent Foramen Ovale [PFO]), and CLOSE (Patent Foramen Ovale Closure or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence) were published. All 3 trials studied young to middle age patients with cryptogenic ischemic strokes found to have a PFO, and compared recurrent stroke rates after PFO closure versus medical therapy alone. All trials had primary end points of recurrent ischemic strokes, a superiority design, and reported results in the intention to treat population. The long-term results of the RESPECT trial led to the Food and Drug Administration approval of the AMPLATZER PFO Occluder for a secondary prevention indication. There was a 45% risk reduction in the device arm for recurrent ischemic stroke with an event rate of 0.58 versus 1.07 per 100 patient-years (hazard ratio, 0.55; 95% confidence interval, 0.305-0.999; log-rank P=0.046). The primary efficacy result of the REDUCE trial utilizing the HELEX and CARDIOFORM devices demonstrated a risk reduction of 77% (hazard ratio, 0.23; 95% confidence interval, 0.09-0.62; log-rank P=0.001). In the CLOSE trial, device closure plus long-term antiplatelet therapy versus antiplatelet therapy alone demonstrated a risk reduction of 97% (hazard ratio, 0.03; 95% confidence interval, 0-0.25; log-rank P<0.001). Each trial demonstrated a low frequency of device- and procedure-related complications, including a slight increase in the rate of paroxysmal atrial fibrillation in the device arm. This review focuses on summarizing the trial results and translating the results and methods from investigative trials into clinical practice.

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.

Far From the Septum: Transcatheter Cardioform Septal Occluder Device Closure of a Descending Aortic Pseudoaneurysm Late After Interrupted Aortic Arch Repair

An asymptomatic 34-year-old woman with DiGeorge syndrome and interrupted aortic arch type B presented for care. She had undergone neonatal palliation with a 6-mm interposition graft followed by 16-mm extra-anatomic ascending to descending aortic jump graft placement in childhood. Screening cardiac

Patent foramen ovale closure with GORE HELEX or CARDIOFORM Septal Occluder vs. antiplatelet therapy for reduction of recurrent stroke or new brain infarct in patients with prior cryptogenic stroke: Design of the randomized Gore REDUCE Clinical Study.

Rationale The utility of patent foramen ovale (PFO) closure for secondary prevention in patients with prior cryptogenic stroke is uncertain despite multiple randomized trials completed to date. Aims The Gore REDUCE Clinical Study (REDUCE) aims to establish superiority of patent foramen ovale 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 who have had a cryptogenic stroke. Methods and design This controlled, open-label trial randomized 664 subjects with cryptogenic stroke at 63 multinational sites in a 2:1 ratio to either antiplatelet therapy plus patent foramen ovale closure (with GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder) or antiplatelet therapy alone. Subjects will be prospectively followed for up to five years. Neuroimaging is required for all subjects at baseline and at two years or study exit. Study outcomes The two co-primary endpoints for the study are freedom from recurrent clinical ischemic stroke through at least 24 months post-randomization and incidence of new brain infarct (defined as clinical ischemic stroke or silent brain infarct) through 24 months. The primary analyses are an unadjusted log-rank test and a binomial test of subject-based proportions, respectively, both on the intent-to-treat population, with adjustment for testing multiplicity. Discussion The REDUCE trial aims to target a patient population with truly cryptogenic strokes. Medical therapy is limited to antiplatelet agents in both arms thereby reducing confounding. The trial should determine whether patent foramen ovale closure with the Gore septal occluders is safe and more effective than medical therapy alone for the prevention of recurrent clinical ischemic stroke or new silent brain infarct; the neuroimaging data will provide an opportunity to further support the proof of concept. The main results are anticipated in 2017. Registration Clinical trial registration-URL: http://clinicaltrials.gov/show/NCT00738894.

Closure of patent foramen ovale defects using GORE® CARDIOFORM septal occluder: Results from a prospective European multicenter study.

The GORE® CARDIOFORM Septal Occluder (GSO) is a novel device designed for rapid and effective closure of patent foramen ovale (PFO) which has distinctive features making it suitable for a broad spectrum of anatomical variations. We report the procedural and 6 months follow-up results of the first prospective, multicenter study using GSO. This single-arm study included 150 subjects undergoing closure of PFO in 10 European centers. In 149 out of 150 patients implantation of a GSO device was successful. One patient had a different PFO-closure device implanted. Periprocedural complications were few including one patient with suspected transient ischemic attack, two access site bleedings, and one patient with AV-fistula. No device embolization occurred. During the 6-month follow-up period one patient had a transient asymptomatic thrombus on the device and four patients (2.6%) were diagnosed new onset paroxysmal atrial fibrillation, which were successfully treated. No thrombembolic events occurred. Closure was successful in 94.2% of subjects at discharge evaluation and 96.9% at 6 months follow-up. This prospective, multicenter study adds to previous published data and suggests that GSO is a versatile device for PFO closure with high procedural and closure success rates and low complication rates through mid-term follow-up. © 2017 Wiley Periodicals, Inc.

Percutaneous transcatheter patent foramen ovale closure with a GORE® CARDIOFORM Septal Occluder device via the right internal jugular venous approach

Percutaneous transcatheter patent foramen ovale closure with a GORE® CARDIOFORM Septal Occluder device via the right internal jugular venous approach

TCT-31 Title: Immediate and One Year U.S. IDE Trial Results of the New GORE® CARDIOFORM Septal Occluder for Transcatheter Closure of Secundum Atrial Septal Defects

The GORE® CARDIOFORM Septal Occluder (studied as GORE® Septal Occluder) was recently FDA approved for the transcatheter treatment of ostium secundum atrial septal defects. It is a low profile double disc device composed of a nitinol 5-wire frame, and covered with expanded polytetrafluoroethylene.