STARFlex Device Research Articles

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 …

Practice advisory: Recurrent stroke with patent foramen ovale (update of practice parameter): Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology.

To update the 2004 American Academy of Neurology guideline for patients with stroke and patent foramen ovale (PFO) by addressing whether (1) percutaneous closure of PFO is superior to medical therapy alone and (2) anticoagulation is superior to antiplatelet therapy for the prevention of recurrent stroke. Systematic review of the literature and structured formulation of recommendations. Percutaneous PFO closure with the STARFlex device possibly does not provide a benefit in preventing stroke vs medical therapy alone (risk difference [RD] 0.13%, 95% confidence interval [CI] -2.2% to 2.0%). Percutaneous PFO closure with the AMPLATZER PFO Occluder possibly decreases the risk of recurrent stroke (RD -1.68%, 95% CI -3.18% to -0.19%), possibly increases the risk of new-onset atrial fibrillation (AF) (RD 1.64%, 95% CI 0.07%-3.2%), and is highly likely to be associated with a procedural complication risk of 3.4% (95% CI 2.3%-5%). There is insufficient evidence to determine the efficacy of anticoagulation compared with antiplatelet therapy in preventing recurrent stroke (RD 2%, 95% CI -21% to 25%). Clinicians should not routinely offer percutaneous PFO closure to patients with cryptogenic ischemic stroke outside of a research setting (Level R). In rare circumstances, such as recurrent strokes despite adequate medical therapy with no other mechanism identified, clinicians may offer the AMPLATZER PFO Occluder if it is available (Level C). In the absence of another indication for anticoagulation, clinicians may routinely offer antiplatelet medications instead of anticoagulation to patients with cryptogenic stroke and PFO (Level C).

Unresolved or Contradictory Issues About Management of Patients With Patent Foramen Ovale and Previous Cryptogenic Stroke: Additional Randomized Controlled Trials Are Eagerly Awaited.

Stating a well-codified and widely accepted therapeutic conduct for patients with patent foramen ovale (PFO) and previous cryptogenic stroke is made difficult and somewhat controversial by several issues remained unresolved so far. In this short review, some aspects of the possible role played by the PFO in the pathogenesis of cryptogenic stroke are succinctly analyzed. First, some aspects of cardiovascular anatomy of the human fetus and the adult are outlined. Subsequently, the three randomized controlled trials (RCTs) that have been accomplished so far to compare the implant of a transeptal occluding device with a simple medical therapy in patients with PFO and history of cryptogenic stroke are briefly examined. These RCTs, when assessed using the “intention to treat” method, do not show a greater protective effect of therapy with transeptal device as regards the recurrences of stroke. Afterwards, there is a brief presentation of the findings of several meta-analyses that have been derived from the three above mentioned RCTs, whose results are strikingly discordant with each other. In fact, some of them come to the conclusion that the transcatheter closure of PFO does not offer significant advantages compared to antithrombotic therapy for the secondary prevention of cryptogenic stroke, while others based on subgroup analyses argue that the transcatheter closure of PFO with Amplatzer device, differently from the one performed using the STARFlex device, would be associated with significantly lower incidence of cerebrovascular events compared with medical therapy alone. Finally, the authors argue the need to adhere to the current scientific guidelines. They substantially deny an alleged superior efficacy of transcatheter PFO occlusion compared to medical therapy with antithrombotic agents (anticoagulants or antiplatelet agents), except for selected cases of patients with documented PFO and concomitant clinical-instrumental picture of deep venous thrombosis.

Predictors of Recurrent Events in Patients With Cryptogenic Stroke and Patent Foramen Ovale Within the CLOSURE I (Evaluation of the STARFlex Septal Closure System in Patients With a Stroke and/or Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale) Trial

ObjectivesThis study sought to identify predictors of recurrent ischemic neurologic events within the CLOSURE I (Evaluation of the STARFlex Septal Closure System in Patients With a Stroke and/or Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale) trial. BackgroundThe CLOSURE I trial found that transcatheter patent foramen ovale (PFO) closure using the STARFlex device was not superior to medical therapy in patients with cryptogenic stroke or transient ischemic attack (TIA) and PFO. MethodsThe CLOSURE I trial is a multicenter, randomized trial of transcatheter PFO closure compared with medical therapy in patients who presented with cryptogenic stroke or TIA and had a PFO. We identified clinical predictors of recurrent ischemic stroke or TIA during 2 years of follow-up using Cox proportional hazards regression within the pooled intention-to-treat cohort. ResultsIn 909 patients, the incidence of recurrent events was 5.7% with 25 patients suffering a recurrent stroke and 30 a TIA. Patients who had a recurrent event had higher body mass index (30.2 ± 6.2 vs. 28.3 ± 5.8%; p = 0.03) and more frequently had diabetes (19.2% vs. 7.1%; p = 0.0016), hypertension (46.2% vs. 30.1%; p = 0.015), and ischemic heart disease (3.8% vs. 0.9%; p = 0.05). Diabetes (hazard ratio [HR]: 3.39; 95% confidence interval [CI]: 1.69 to 6.84; p = 0.0007), index TIA (HR vs. stroke: 2.13; 95% CI: 1.20 to 3.80; p = 0.01), and the detection of atrial fibrillation after study enrollment (HR: 4.85; 95% CI: 2.05 to 11.47; p = 0.0003) independently predicted recurrent ischemic neurologic events. Recurrent neurologic events were more frequent in subjects with RoPE (Risk of Paradoxical Embolism) score ≤5 than those with >5 (14.5% vs. 4.2%; p < 0.0001). ConclusionsThese findings suggest an alternative etiology to paradoxical embolism was frequently responsible for recurrent events within the CLOSURE I trial. (Evaluation of the STARFlex Septal Closure System in Patients With a Stroke or TIA Due to the Possible Passage of a Clot of Unknown Origin Through a Patent Foramen Ovale (PFO) [CLOSURE I]; NCT00201461)

Patent foramen ovale.

Patent foramen ovale.

Patent foramen ovale, transient ischemic attack and Kounis syndrome

In their important meta-analysis of Ntaios et al.'s study published in this Journal [1], concerning all randomized control trials of patent foramen ovale closure versus medical treatment, the authors found no benefit in the prevention of cryptogenic shock and transient ischemic attack with implantation of unselected devices. However, in a subgroup analysis, selected closure devices may be superior to medical therapy without increasing the risk of new-onset atrial fibrillation. Indeed, in the CLOSURE trial [2] the rate of stroke, transient ischemic attack, or death did not diminish and the risks of major vascular events and atrial fibrillation were increased despite closure of patent foramen ovale, with the StarFlex device, in comparison with the best medical treatment.

Percutaneous closure of patent foramen ovale: “Closed” door after the last randomized trials?

Patent foramen ovale (PFO) percutaneous closure has previously been an accepted intervention for the prevention of recurrent cryptogenic stroke on the basis of observational studies. However, randomized trials have been lacking until now. Three recently published randomized trials (CLOSURE I, PC and RESPECT) do not demonstrate the superiority of this intervention versus optimal medical therapy, therefore making this practice questionable. Nonetheless, these trials have had certain pitfalls, mainly a lower than initially estimated number of patients recruited, therefore lacking sufficient statistical power. On the other hand, different closure devices were used in the three trials. In two of them (PC and RESPECT), the Amplatzer PFO Occluder was used and the STARflex device was used in the other one (CLOSURE I). Taken altogether, a meta-analysis of these three trials does not demonstrate a statistically significant benefit of percutaneous PFO closure (1.9% vs 2.9%; P = 0.11). However, if we analyze only the PC and RESPECT trials together, in which the Amplatzer PFO Occluder was used, a statistically significant benefit of percutaneous PFO closure is observed (1.4% vs 3.0%, P = 0.04). In conclusion, our interpretation of these trials is that the use of a dedicated, specifically designed Amplatzer PFO device could possibly reduce the risk of stroke in patients with PFO and cryptogenic stroke. This consideration equally applies to patients who have no contraindications for anticoagulant or antithrombotic therapy.

PFO Closure: CLOSURE

The optimal secondary prevention strategy in patients presenting with a cryptogenic stroke or transient ischemic attack (TIA) and a patent foramen ovale (PFO) is uncertain. In the United States, closure of a PFO using a percutaneous transcatheter device is currently considered investigational by the Food and Drug Administration. Nonetheless, many patients in this setting are treated off-label with devices that are approved for the closure of secundum atrial septal defects. There are also no definitive data about the use of medical therapy for secondary stroke prevention in this patient population. We evaluated the potential benefit of device closure of a PFO in this setting in CLOSURE I (evaluation of the STARFlex Septal Closure System in patients with a stroke and/or TIA because of presumed paradoxical embolism through a PFO).1 CLOSURE I was a prospective, multicenter, randomized, open-label, 2-arm superiority trial. The trial was sponsored by NMT Medical, Inc. The protocol was designed by the Executive Committee in consultation with the Food and Drug Administration, and was approved by the institutional review board at each participating site. Methodological details have been previously published.1,2 ### Study Subjects Subjects were eligible for randomization if they were aged between 18 and 60 years, had had an ischemic stroke or TIA within the previous 6 months, and had evidence of a PFO with right to left shunting documented by a transesophageal echocardiogram. Exclusion criteria included any identified potential source of ischemic stroke or TIA other than the PFO.2 ### Study Procedures Eligible patients were randomly assigned in a 1:1 ratio to either device therapy or medical therapy. Randomization was stratified by study site and by presence or absence of an atrial septal aneurysm. Patients assigned to device therapy underwent percutaneous closure of their PFO with the STARFlex device (NMT Medical, Inc). After the procedure, all patients …

Patent Foramen Ovale Closure for Cryptogenic Stroke: Two More Studies

In the CLOSURE I trial, published in 2012 (JW Neurol Mar 14 2012), percutaneous closure of patent foramen ovale (PFO) with the STARFlex device did not

Transcatheter Closure of Post-myocardial Infarction Ventricular Septal Rupture

Ventricular septal rupture (VSR) after acute myocardial infarction (AMI) is a potentially lethal mechanical complication of acute coronary syndromes. Given high surgical mortality, transcatheter closure has emerged as a potential strategy in selected cases. We report our single-center experience with double-umbrella device percutaneous closure of post-AMI VSR. In this single-center, retrospective, cohort study, patients who underwent transcatheter closure of post-AMI VSR between 1988 and 2008 at Boston Children's Hospital were included. Data were analysed according to whether the patients underwent direct percutaneous VSR closure or closure of a residual VSR after a previous surgical approach. Primary outcome was mortality rate at 30 days. Clinical predictors of primary outcome were investigated using univariate logistic regression. Thirty patients were included in the study (mean age, 67±8 years). A total of 40 closure devices were implanted. Major periprocedural complications occurred in 4 (13%) patients. Cardiogenic shock, increasing pulmonary/systemic flow ratio, and the use of the new generation (6-arm) STARFlex device all were associated with higher risk of mortality. The Model for End-Stage Liver Disease Excluding international normalized ratio (MELD-XI) score at the time of VSR closure seemed to be most strongly associated with death (odds ratio, 1.6; confidence interval, 1.1-2.2; P<0.001). Transcatheter closure of post-AMI VSR using CardioSEAL or STARFlex devices is feasible and effective. The MELD-XI score, a marker of multiorgan dysfunction, is a promising risk stratifier in this population of patients. Early closure of post-AMI VSR is advisable before establishment of multiorgan failure.

Letter by Furlan Regarding “Critique of Closure or Medical Therapy for Cryptogenic Stroke With Patent Foramen Ovale: The Hole Truth?”

Thaler and Wahl1 repeatedly characterize the CLOSURE I2 trial as having gone wrong. Such moralistic (mis)characterizations betray the prevalent bias toward devices in patients with cryptogenic stroke and a patent foramen ovale (PFO). Although disappointing to some, better to say CLOSURE I failed to prove that the StarFlex device was superior to medical therapy for stroke prevention, in this particular cryptogenic population with PFO. This result is neither wrong nor right. Wrong patient–Contrary to clinical practice, CLOSURE I used an independently adjudicated and rigorous definition of transient ischemic attack (TIA). In clinical practice, failure to use a rigorous definition of TIA can lead to inappropriate device closure of a PFO for spells unrelated to ischemia or paradoxical embolism. If by wrong, Thaler and Wahl also meant patients were randomized …

Thrombus formation 10 years after placement of an atrial septal secundum defect closure device

A 65-year-old female patient with a 24 mm atrial septal secundum defect underwent successful percutaneous closure of the defect 10 years earlier using a 38 mm StarFlex device; NMT Medical, Boston, MA, USA. The patient was …

First experience With the biostar‐device for various applications in pediatric patients With congenital heart disease

Interventional closure of atrial septal defects (ASD) and surgical tunnel fenestrations in Fontan patients has become the procedure of choice for many years. Recently, the BioSTAR Occluder, a modification of the Starflex device with a resorbable matrix has become available. Ten Biostar devices were implanted in nine children with interatrial septal defects, one within a fontan baffle, eight with secundum atrial septal defects. The age of the patients ranged from 11 months to 17 years, the body weight ranged from 12.9-78 kg. 10 BioSTAR devices were implanted in nine patients. In one patient, two BioSTAR devices were used to occlude multiple defects within the oval fossa. All defects were successfully and uneventfully occluded. Mean procedure time was 56 (range 28-125). Mean fluoroscopy time was 4.8 (range 1.1 to 13.0) min. None of the nine patients showed residual shunts after device implantation. After 30 days no shunt was seen in the control transthoracic echocardiography. No adverse effects like allergic reactions, tachyarrhythmia or thrombembolic events occurred in any of the patients. The BioSTAR closure device is a safe and effective device for the closure of a variety of interatrial shunts in children including multifenestrated interatrial defects and fontan fenestrations, however, possible long term consequences (e.g., fractures, recurrent shunts after scaffold degradation) remain to be studied.

Long‐term follow‐up of the STARFlex device for closure of secundum atrial septal defect

Catheterization and Cardiovascular InterventionsVolume 74, Issue 3 p. 525-526 Letter to the Editor Long-term follow-up of the STARFlex device for closure of secundum atrial septal defect† Carlos E. Ruiz MD, PhD, FACC, FSCAI, Carlos E. Ruiz MD, PhD, FACC, FSCAI Department of Cardiac and Vascular, Interventional Services, Lenox Hill, Heart and Vascular, Institute of New York, New York, New YorkSearch for more papers by this authorHoward A. Cohen MD, FACC, FSCAI, Howard A. Cohen MD, FACC, FSCAI Department of Cardiac and Vascular, Interventional Services, Lenox Hill, Heart and Vascular, Institute of New York, New York, New YorkSearch for more papers by this authorAlan W. Nugent MD, Alan W. Nugent MD UT Southwestern Medical Center, Children's Medical Center, Dallas, TexasSearch for more papers by this authorPaul Kramer MD, FACC, FSCAI, Paul Kramer MD, FACC, FSCAI MidAmerica Heart, Vascular, and Vein Specialists, PA, Shawnee Mission, KansasSearch for more papers by this author Carlos E. Ruiz MD, PhD, FACC, FSCAI, Carlos E. Ruiz MD, PhD, FACC, FSCAI Department of Cardiac and Vascular, Interventional Services, Lenox Hill, Heart and Vascular, Institute of New York, New York, New YorkSearch for more papers by this authorHoward A. Cohen MD, FACC, FSCAI, Howard A. Cohen MD, FACC, FSCAI Department of Cardiac and Vascular, Interventional Services, Lenox Hill, Heart and Vascular, Institute of New York, New York, New YorkSearch for more papers by this authorAlan W. Nugent MD, Alan W. Nugent MD UT Southwestern Medical Center, Children's Medical Center, Dallas, TexasSearch for more papers by this authorPaul Kramer MD, FACC, FSCAI, Paul Kramer MD, FACC, FSCAI MidAmerica Heart, Vascular, and Vein Specialists, PA, Shawnee Mission, KansasSearch for more papers by this author First published: 13 August 2009 https://doi.org/10.1002/ccd.22080 † Conflict of interest: Dr. Ruiz has been a proctor and consultant for AGA Medical and NMT Medical and is an unpaid consultant for CoAptus. Dr. Kramer owns shares of stock in NMT Medical. The other authors have no conflicts to disclose. Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat No abstract is available for this article. Volume74, Issue31 September 2009Pages 525-526 SCAI Member Sign in RelatedInformation

New onset atrial fibrillation after patent foramen ovale closure

In this study, we evaluated the incidence of new onset atrial fibrillation (symptomatic or detected by routine ECG) after patent foramen ovale (PFO-) closure. Although atrial fibrillation is known to occur in some patients following patent foramen ovale closure, the incidence and the risk associated with each device is not well known. We evaluated 1,349 consecutive patients who underwent PFO closure with an approved device and examined the incidence and risk factors associated with the development of atrial fibrillation. The patients had a mean age of 50 years and underwent PFO closure for cerebrovascular accident in 696 (51.6%), transient ischemic attack in 610 (45.2%), paradoxical embolism in 22 (1.6%), decompression sickness in 13 (0.9%), and other reasons including migraine headaches in 6 (0.4%) of cases. Over a mean follow-up period of 38.1 +/- 28 months, 53 (3.9%) patients developed new onset atrial fibrillation, which is higher compared with an age-matched population. Of these, 33 (62.3%) patients developed atrial fibrillation within 4 weeks and 8 (15%) within 6 months following PFO closure (totally 77% from 0 to 6 months). The event consisted of a single paroxysm lasting less than 48 hr in 23 patients, resolving either spontaneously or with cardioversion. 40 (75.5%) patients were symptomatic at the time of diagnosis. Thirty (56.6%) patients developed chronic atrial fibrillation. On multivariate analysis, advanced age and use of the STARFlex device predicted atrial fibrillation. The number of patients in whom atrial fibrillation was detected was relatively low. It is often a self-limited complication of PFO closure that may occur more frequently in elderly patients and those treated with the STARFlex device.

Long‐term follow‐up of the STARFlex® device for closure of secundum atrial septal defect

There is limited published outcome data on the STARFlex device for transcatheter closure of atrial septal defects (ASD). To contribute to the long term outcomes of ASD device closure with the STARFlex device. Results of a prospective FDA approved clinical trial (1999-2001) from a single institution of the STARFlex device for simple ASD was reviewed. The inclusion criteria included age >or=2 years, isolated secundum ASD, evidence of right ventricular volume overload, and maximum stretched diameter <22 mm. A retrospective review of the original study data with most recent follow-up was performed. Clinical success in the trial was defined as complete closure or residual leak <or=2 mm, absence of a severe complication and no need for an additional device or surgery to treat the ASD. Twenty seven (27) patients were prospectively enrolled in the study period with a procedural success in 23 (85%). There were two severe complications, both 40 mm device embolizations that underwent semiurgent surgical intervention for device removal and ASD closure (40 mm device subsequently withdrawn from trial). Device placement was unsuccessful in two patients due to malposition related to an insufficient retro-aortic rim, with elective surgical closure. Unsuccessful procedural outcomes were statistically associated with deficient rims (P < 0.01). Of the 23 long term follow-up device patients, 23 (100%) achieved clinical success: 22 (96%) had complete closure at 1 year and latest echocardiographic follow-up and one case had a small <2 mm residual defect that has persisted. There have been no late complications with normalization of RV volumes in 92% and no deleterious ECG changes. Device fractures occurred in 8/23 (35%) devices and were more common in the larger devices (P < 0.05) but had no sequelae. None required any further intervention to treat the ASD and there were no infectious or thrombotic issues. In this cohort the STARFlex device for secundum ASD closure provided procedural success in 85% with failures due to surgical referral. All 23 patients with a STARFlex device with available long term follow-up had clinical success. Further long term data is required.

Long‐term follow‐up of the Starflex device for closure of secundum atrial septal defect

Long‐term follow‐up of the Starflex device for closure of secundum atrial septal defect

Cardiac perforation and tamponade 3 months after transcatheter PFO closure by STARFlex device: A case report

Percutaneous Patent Foramen Ovale (PFO) closure after paradoxical embolism has become established as a safe, effective and validated procedure. The use of dedicated devices by experienced operators allows for low complication rates and good clinical results in the prevention of paradoxical embolism recurrence. This has led to a widespread use of the technique. However, late complications have been reported after the implantation of different types of devices. We report the first case of cardiac tamponade due to atrial wall erosion, which occurred three months after the implantation of a STARflex device (Nitinol Medical Technologies, Boston, Massachusetts, USA) in a 57 year-old-patient Transoesophageal echocardiographic images and surgical views of the perforation related to the device are presented. This report describes treatment of a late complication that arose following implantation of a STARflex device.

Transcatheter closure of perimembranous ventricular septal defects using umbrella devices

There is only limited experience of interventional closure of perimembranous ventricular septal defects (pmVSDs), particularly on the long-term follow-up. This is a report on our long-term results after transcatheter closure of pmVSDs using the Cardioseal, Starflex, or Rashkind devices. Between 1993 and 2005, we performed interventional occlusions of pmVSDs in 18 patients. The size of the defect ranged between 4 and 8.5 mm, Q(p)/Q(s) was calculated between 1.3 and 2.2. Except for two, the patients had no other structural heart defect. In the early days, we used the Rashkind PDA occluder (17 mm) in seven, followed by the Cardioseal device (17 mm) in nine, and the 23 mm Starflex device in two patients. Interventional closure of the defects was performed successfully in all patients without any complication during the procedure. Fluoroscopy times were 11.8-53.7 min (median 28.65 min). We achieved a complete closure in 13 patients, three patients with recently implanted devices still show minimal shunting. In two patients the occluder had to be removed surgically because of embolization into the pulmonary artery and significant residual shunting resulting in severe hemolysis in the second patient. In long- (mean 10.7 years) and short-term (mean 0.85 years) follow-up we have not observed any hemolysis, arrhythmias, device dislocations, or device-related aortic or tricuspid regurgitation. Transcatheter closure of small pmVSDs using non-selfcentering devices can be performed successfully. Long-term follow-up investigations show encouraging results. Complications like device-embolization and significant residual shunting occur in the presence of large defects and/or concomitant malformations.

The “pull–push” technique to deal with a redundant eustachian valve interfering with placement of a PFO occluder

To evaluate the role of a new technique to deal with a redundant Eustachian valve (EV) interfering with placement of a patent foramen ovale (PFO) occluder. The EV is a remnant of the embryonic valve of the sinus venosus. In rare occasions, it is large and redundant and it may interfere with catheters and devices used in cardiac catheterization. We have developed a new technique to control the EV in order to avoid interferences with the device for closure of atrial septal defects and PFO's. This technique is called "pull-push" technique and consists in pulling down on the inferior vena cava the redundant EV by using a 6 Fr pigtail catheter while a second operator pushes the right atrial disc out of the long sheath. Here, we report on two patients with a patent foramen ovale, in whom the EV prevented the right atrial disc of an Amplatzer PFO occluder to be completely flat against the interatrial septum. Finally, we used this technique in one more patient to avoid any interference of a very redundant EV during placement of a Starflex device. In conclusion. the so called "pull-push" technique is an alternative and easy technique to control the EV in order to avoid interferences with the device for closure of atrial septal defects and PFO's