Percutaneous decannulation of extracorporeal membrane oxygenation using a plug-based closure device.

BACKGROUND: There is limited experience of using the MANTA plug-based vascular closure device for percutaneous arterial closure of the femoral artery after venoarterial extracorporeal membrane oxygenation. OBJECTIVES: To study femoral artery complications and need for subsequent vascular interventions after percutaneous decannulation of venoarterial extracorporeal membrane oxygenation (VA ECMO) using the MANTA plug-based vascular closure device. METHODS: We studied 34 consecutive patients who underwent percutaneous decannulation of VA ECMO using the MANTA device. Primary outcomes were conversion to surgical cutdown of the groin at decannulation (immediate) or later. Secondary outcomes were type of vascular complication necessitating conversion to surgical cutdown of the groin. RESULTS: Six (17.7%) patients had to undergo immediate (n = 3) or late (n = 3) conversion to surgical cutdown of the groin. Of these, three were owing to occlusion of the common femoral artery resulting in insufficient distal perfusion and three owing to bleeding or pseudoaneurysm. The mechanism of failure was complete intravascular deployment of the MANTA device in three patients, incomplete MANTA sealing of the arteriotomy in one patient, MANTA-unrelated thrombotic occlusion in one patient, and unknown in one patient. Surgical cut-down was typically performed with concomitant catheter thrombectomy with or without patch reconstruction of the artery. CONCLUSION: Percutaneous decannulation of VA ECMO using the MANTA VCD was feasible but a substantial number of patients needed to be converted to unplanned surgical repair, owing to either closure site-located stenosis/occlusion or bleeding. If suboptimal MANTA positioning is suspected, a low threshold for conversion to surgical cutdown of the groin is recommended.

Atrial fibrillation after closure of patent foramen ovale in the REDUCE clinical study.

OBJECTIVES: To describe the occurrence of postprocedural atrial fibrillation (AF) among patients with cryptogenic stroke undergoing patent foramen ovale (PFO) closure in the REDUCE clinical study and analyze for potential risk factors for the development of postprocedural AF. BACKGROUND: AF is an adverse event that might potentially counterbalance the stroke prevention benefit from PFO closure. Data on AF after transcatheter PFO closure are sparse. METHODS: We evaluated data from patients having PFO closure (Gore HELEX or Gore Cardioform Septal Occluder) in the REDUCE clinical trial (n = 408) in at post hoc explorative analysis. Median follow-up was 5.0 years. RESULTS: AF occurred in 30 patients (7.4%) after PFO closure with a total of 34 AF events. Most were reported as non-serious (68%), detected within 45 days post-procedure (79%), and resolved within 2 weeks of onset (63%). One subject with AF had recurrent stroke. Postprocedural AF occurred more frequently among subjects with higher age and large device sizes. Male sex was the only independent predictor of postprocedural AF. We found no association between the type of occluder (HELEX or Gore Cardioform Septal Occluder) or PFO anatomical characteristics and post-procedural AF. CONCLUSION: In the REDUCE clinical study, postprocedural atrial fibrillation was mostly early onset, transient and with no later recurrence. Postprocedural AF occurred more frequently among patients with higher age and larger devices. Male sex was the only independent predictor of postprocedural AF.

Safety evaluation of high-risk myocardial micro-biopsy in a swine model.

The objective of the study was to investigate the safety profile of high-risk micro-endomyocardial biopsy (micro-EMB) compared to conventional EMB in a large animal model. Twenty pigs were subjected to a maximum of 30 consecutive biopsies, including sampling from the free ventricular wall, with either micro-EMB (n = 10) or conventional EMB (n = 10). There were no major complications in the micro-EMB group (0/10), compared to six major complications in the EMB group (6/10; p = 0.003). Survival analysis further highlighted these differences (p = 0.004). There were significantly higher volumes of pericardial effusion in the EMB group (p = 0.01). The study shows a safety advantage of micro-EMB compared to standard EMB in the experimental high-risk circumstances investigated in this animal study. These results indicate enhanced possibilities to collect samples from sensitive areas by using the micro-EMB technique instead of standard EMB.

Arginase 1 is upregulated at admission in patients with ST-elevation myocardial infarction.

BACKGROUND: The mechanisms underlying rupture of a coronary atherosclerotic plaque and development of myocardial ischemia-reperfusion injury in ST-elevation myocardial infarction (STEMI) remain unresolved. Increased arginase 1 activity leads to reduced nitric oxide (NO) production and increased formation of reactive oxygen species due to uncoupling of the NO-producing enzyme endothelial NO synthase (eNOS). This contributes to endothelial dysfunction, plaque instability and increased susceptibility to ischemia-reperfusion injury in acute myocardial infarction. OBJECTIVE: The purpose of this study was to test the hypothesis that arginase gene and protein expression are upregulated in patients with STEMI. METHODS: Two cohorts of patients with STEMI were included. In the first cohort (n = 51), expression of arginase and NO-synthases as well as arginase 1 protein levels were determined and compared to a healthy control group (n = 45). In a second cohort (n = 68), plasma arginase 1 levels and infarct size were determined using cardiac magnetic resonance imaging. RESULTS: Expression of the gene encoding arginase 1 was significantly elevated at admission and 24-48 h after STEMI but not 3 months post STEMI, in comparison with the control group. Expression of the genes encoding arginase 2 and endothelial NO synthase (NOS3) were unaltered. Arginase 1 protein levels were elevated at admission, 24 h post STEMI and remained elevated for up to 6 months. No significant correlation between plasma arginase 1 protein levels and infarct size was observed. CONCLUSION: The markedly increased gene and protein expression of arginase 1 already at admission indicates a role of arginase 1 in the development of STEMI.

Long-term effect of remote ischemic conditioning on infarct size and clinical outcomes in patients with anterior ST-elevation myocardial infarction.

BACKGROUND: Conflicting evidence exists concerning the cardioprotective efficacy of remote ischemic conditioning as an adjunct to primary percutaneous intervention (PCI) in ST-elevation myocardial infarction (STEMI) and data on long-term outcomes are scarce. We evaluated final infarct size by cardiac magnetic resonance (CMR) performed 6 months after anterior STEMI treated with remote ischemic conditioning and clinical outcomes up to 3 years after the event. METHODS: One hundred and fifteen patients with anterior STEMI were randomized to remote ischemic per-postconditioning (RIperpostC) or sham procedure as adjunct to primary PCI. The primary outcome was myocardial salvage index (MSI) on CMR 6 months after the event. Secondary outcomes were absolute infarct size, left ventricular function, cardiac mortality, major adverse cardiac and cerebrovascular events (MACCE-composite of all-cause mortality, myocardial infarction, readmission for heart failure, ischemic stroke, and target lesion revascularization) and all the individual components of MACCE. RESULTS: There was no difference in MSI or left ventricular function between the RIperpostC and the control group after 6 months. Nor did clinical outcomes at 6 months or 3 years differ between the groups. CONCLUSIONS: RIperpostC as an adjunct to PCI in anterior STEMI did not result in better MSI or left ventricular function 6 months after the event. Furthermore, clinical outcomes at 6 months and 3 years were not altered.

Left atrial appendage occlusion with the Amplatzer™ Amulet™ device: full results of the prospective global observational study.

AIMS: To evaluate the safety and efficacy of left atrial appendage occlusion (LAAO) with the Amplatzer™ Amulet™ occluder. METHODS AND RESULTS: Patients with atrial fibrillation eligible for LAAO were recruited to a prospective global study. Implant procedures were undertaken with echocardiographic guidance. Transoesophageal echocardiography (TOE) was undertaken 1-3 months post-LAAO. Implant and follow-up TOEs were evaluated by a CoreLab. The primary endpoint was a composite of ischaemic stroke and cardiovascular death at 2 years. Serious adverse events were adjudicated by an independent clinical events committee. A total of 1088 patients were enrolled, aged 75.2 ± 8.5 years; 64.5% were male. CHA2DS2-VASc and HAS-BLED scores were 4.2 ± 1.6 and 3.3 ± 1.1, respectively. A total of 71.7% had prior major bleeding, and 82.8% had contraindications to oral anticoagulants. Implant success was 99.1%. Major adverse events (≤7 days post-procedure) occurred in 4.0%, including death (0.3%), stroke (0.4%), major vascular (1.3%), and device embolization (0.2%). A total of 80.2% of patients were discharged on antiplatelet therapy alone. Peridevice flow was <3 mm in 98.4% at follow-up TOE. Device-related thrombus (DRT) was seen in 1.6% of cases. Cardiovascular death or ischaemic stroke occurred in 8.7% of patients at 2 years. The ischaemic stroke rate was 2.2%/year-a 67% reduction compared to the CHA2DS2-VASc predicted rate. Major bleeding (Bleeding Academic Research Consortium type ≥ 3) occurred at rates of 10.1%/year (year 1) and 4.0%/year (year 2). CONCLUSION: Following LAAO with the Amplatzer Amulet device, the ischaemic stroke rate was reduced by 67% compared to the predicted risk. Closure was complete in 98.4% of cases and DRT seen in only 1.6%.

Patent Foramen Ovale Closure or Antiplatelet Therapy for Cryptogenic Stroke.

BACKGROUND: The efficacy of closure of a patent foramen ovale (PFO) in the prevention of recurrent stroke after cryptogenic stroke is uncertain. We investigated the effect of PFO closure combined with antiplatelet therapy versus antiplatelet therapy alone on the risks of recurrent stroke and new brain infarctions. METHODS: In this multinational trial involving patients with a PFO who had had a cryptogenic stroke, we randomly assigned patients, in a 2:1 ratio, to undergo PFO closure plus antiplatelet therapy (PFO closure group) or to receive antiplatelet therapy alone (antiplatelet-only group). Imaging of the brain was performed at the baseline screening and at 24 months. The coprimary end points were freedom from clinical evidence of ischemic stroke (reported here as the percentage of patients who had a recurrence of stroke) through at least 24 months after randomization and the 24-month incidence of new brain infarction, which was a composite of clinical ischemic stroke or silent brain infarction detected on imaging. RESULTS: We enrolled 664 patients (mean age, 45.2 years), of whom 81% had moderate or large interatrial shunts. During a median follow-up of 3.2 years, clinical ischemic stroke occurred in 6 of 441 patients (1.4%) in the PFO closure group and in 12 of 223 patients (5.4%) in the antiplatelet-only group (hazard ratio, 0.23; 95% confidence interval [CI], 0.09 to 0.62; P=0.002). The incidence of new brain infarctions was significantly lower in the PFO closure group than in the antiplatelet-only group (22 patients [5.7%] vs. 20 patients [11.3%]; relative risk, 0.51; 95% CI, 0.29 to 0.91; P=0.04), but the incidence of silent brain infarction did not differ significantly between the study groups (P=0.97). Serious adverse events occurred in 23.1% of the patients in the PFO closure group and in 27.8% of the patients in the antiplatelet-only group (P=0.22). Serious device-related adverse events occurred in 6 patients (1.4%) in the PFO closure group, and atrial fibrillation occurred in 29 patients (6.6%) after PFO closure. CONCLUSIONS: Among patients with a PFO who had had a cryptogenic stroke, the risk of subsequent ischemic stroke was lower among those assigned to PFO closure combined with antiplatelet therapy than among those assigned to antiplatelet therapy alone; however, PFO closure was associated with higher rates of device complications and atrial fibrillation. (Funded by W.L. Gore and Associates; Gore REDUCE ClinicalTrials.gov number, NCT00738894 .).

Is There Currently a Place for Combined Mitral and Aortic Transcatheter Interventions?

PURPOSE OF REVIEW: The goal was to evaluate published data on the incidence, diagnosis, and management of symptomatic combined mitral and aortic valvular disease. Furthermore, to identify the role of treatment using contemporary transcatheter techniques. RECENT FINDINGS: Up to a quarter of symptomatic adult valvular disease is caused by multiple left-sided valvular lesions. The etiologic spectrum of this combined disease has shifted from rheumatic to degenerative. Both presentation and diagnosis of lesions are modified compared with isolated disease. Based upon narrative review, there are only limited observational experiences, insufficient to provide robust guidance. These data, however, indicate the feasibility of interventions such as transcatheter aortic valve replacement and edge-to-edge mitral valve repair to treat such disease and mitigate the risks of open surgery. Combined aortic and mitral valve disease is commonly encountered. There is a role for transcatheter interventions based on limited data; however, more research is needed.

Impact of percutaneous femoral arteriotomy closure using the MANTATM device on vascular and bleeding complications after transcatheter aortic valve replacement.

OBJECTIVES: To evaluate the feasibility of fully percutaneous closure using a novel collagen-based vascular closure device after transfemoral aortic valve replacement (TAVR). BACKGROUND: TAVR is utilized increasingly for the treatment of severe symptomatic aortic stenosis. Vascular complications related to access and closure dominate the adverse event profile of the procedure despite progressively reducing arteriotomy caliber. The advent of a novel collagen-based device (MANTATM ) and preliminary data suggest this could be used as a routine percutaneous closure device. METHODS: A prospective observational study of unselected consecutive patients undergoing TAVR in a single center. Data were collected via hospital electronic records and the SWEDEHEART registry. The primary clinical outcome was closure success and time to hemostasis. Secondary outcomes included VARC-2 defined major and minor vascular and bleeding complications within 30 days using suture-based closure with Prostar-XL within the same center. RESULTS: A consecutive cohort of 346 patients underwent TAVR via the transfemoral approach. Vascular closure with MANTATM was successful in all with a mean time to hemostasis of 42 sec (SD 115.5, range 0-600). The composite of all-cause mortality and major complications related to the main access site was similar between the groups (1.1% vs 1.9%, P = .61). Major bleeding occurred less frequently with MANTA TM (1.1% vs 7.8%, P = .02). CONCLUSION: The novel use of a collagen-based vascular closure device for large caliber arteriotomy is feasible in an unselected population undergoing transfemoral TAVR and appears efficacious compared to percutaneous suture-based closure. These data should prompt larger studies to evaluate efficacy and safety.

Percutaneous axillary arteriotomy closure during transcatheter aortic valve replacement using the MANTA device.

Percutaneous aortic valve replacement is performed predominantly via the transfemoral approach. The transaxillary (subclavian) approach may be utilized if an alternative route access is required. Conventional access and closure for this approach necessitates open surgical techniques. We report a nonsurgical fully percutaneous axillary TAVR using a collagen-based vascular closure device.

Rationale and design of a global registry to evaluate real-world clinical outcomes in patients with atrial fibrillation and high risk of stroke treated with left atrial appendage occlusion using the AMPLATZER amulet device-Perspective of available/ongoing registries of catheter-based LAA occlusion.

OBJECTIVES: To describe the rationale and design of a global prospective registry on catheter-based left atrial appendage (LAA) occlusion using the second generation AMPLATZER Amulet LAA occlusion device and to provide a comprehensive perspective on available/ongoing registries for catheter-based LAA occlusion. BACKGROUND: Given the increasing clinical application of catheter-based LAA occlusion, there is an important need for prospective real-world clinical data regarding this cardiac intervention. METHODS: The Global Amplatzer Amulet LAA registry aims to provide prospective real-world data from an all-comer population of atrial fibrillation (AF) patients undergoing catheter-based LAA occlusion for stroke prevention. This observational, prospective, multicenter registry will provide peri-procedural and long-term clinical outcome data for catheter-based LAA occlusion using a second generation LAA occlusion device. The global registry will enroll 1,000 patients at up to 75 institutions. Patients will be followed for 2 years after implantation. Primary endpoints will report procedural and long-term data on ischemic stroke, systemic embolism, cardiovascular death and major bleeding. The study will involve independent event adjudication and echocardiographic core laboratory evaluation. Long-term follow-up data are expected in 2018. RESULTS: The Global Amplatzer Amulet LAA registry will collect safety and efficacy information on catheter-based LAA occlusion. Characteristics of available and ongoing catheter-based LAA occlusion registries are described. CONCLUSIONS: There is an important need for prospective real-world clinical data of catheter-based LAA occlusion given the increasing application of this intervention. The present global real-world registry will expand our knowledge on peri-procedural and long-term outcome of catheter-based LAA occlusion using a second generation occlusion device.

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

AIMS: 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. METHODS AND RESULTS: 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. CONCLUSION: 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.

Impaired endothelial function in patients with cryptogenic stroke and patent foramen ovale is not affected by closure.

INTRODUCTION: Patent foramen ovale (PFO) is associated with cryptogenic stroke (CS) and migraine with aura (MA). Endothelial dysfunction (ED) is a risk factor for development of cardiovascular disease, but might also be involved in migraine pathophysiology. Short-term worsening of migraine has been described after closure of PFO. We evaluated endothelial function in patients with CS and PFO, before and after closure of PFO, and in patients with migraine, whether changes in endothelial function was related to a change in migraine frequency. MATERIAL AND METHODS: Patients with CS and PFO were included; 20 with planned closure of PFO and seven controls on medical treatment only. Endothelial function was assessed by peripheral arterial tonometry (EndoPatR ) and biomarkers of endothelial activation. Patients were followed longitudinally at baseline, day 1, 1 month, and 6 months. A headache diary was used to assess migraine frequency. RESULT: Mean age of the cohort was 45.4 years, and migraine prevalence was 50% whereof 84.6% had MA. Median EndoPatR index (RHI) at baseline was 1.60 (IQR 1.41-2.00). There was no change in RHI over time, either in closure patients (P = 0.66), nor in controls (P = 0.31), and there was no change in biomarkers of endothelial activation. Three migraine patients experienced worsening of migraine frequency directly after closure. DISCUSSION: Endothelial function did not change after closure of PFO. Although patients were lacking cardiovascular risk factors, a high proportion had impaired endothelial function. Whether ED can have predictive value, identifying PFO at higher risk for recurrent stroke warrants further investigations.

A Path to Avoid during Transcatheter Aortic Valve Implantation: Case Report.

Collateral pathways in vascular disease are important natural "bypass" conduits that protect against ischemia. Endovascular diagnostic and therapeutic procedures via peripheral access sites are performed frequently. This case report underlines the importance of being aware of collateral circulation in patients with chronic aortoiliac occlusive disease undergoing subclavian transcatheter aortic valve implantation to avoid acute limb ischemia. (©) RSNA, 2016.

Effect of remote ischemic conditioning on infarct size in patients with anterior ST-elevation myocardial infarction.

BACKGROUND: Previous studies indicate that remote ischemic conditioning performed before percutaneous coronary intervention (PCI) reduces infarct size in patients with ST-elevation myocardial infarction (STEMI). It remains unclear whether remote conditioning affords protection when performed in adjunct to primary PCI. We aimed to study whether remote ischemic per-postconditioning (RIperpostC) initiated after admission to the catheterization laboratory attenuates myocardial infarct size in patients with anterior STEMI. METHODS: In this prospective multicenter trial 93 patients with anterior STEMI were randomized to RIperpostC or sham procedure as adjunct to primary PCI. RIperpostC was started on arrival in the catheterization laboratory by 5-minute cycles of inflation and deflation of a blood pressure cuff around the left thigh and continued throughout the PCI procedure. Infarct size and myocardium at risk were determined by cardiac magnetic resonance at day 4 to 7. The primary outcome was myocardial salvage index. RESULTS: There was no significant difference in myocardial salvage index between the RIperpostC and control group (median 48.5% and interquartile range 30.9%-60.8% vs 49.2% [42.1%-58.8%]). Neither did absolute infarct size in relation to left ventricular myocardial volume differ significantly (RIperpostC 20.6% [14.1%-31.7%] vs control 17.9% [13.4%-25.0%]). The RIperpostC group had larger myocardial area at risk than the control group (43.1% (35.4%-49.7%) vs 37.0% (30.8%-44.1%) of the left ventricle, P=.03). Peak value and area under the curve for troponin T did not differ significantly between the study groups. CONCLUSIONS: RIperpostC initiated after admission to the catheterization laboratory in patients with anterior STEMI did not confer protection against reperfusion injury.

Transcatheter Aortic Valve Replacement Using the Portico System: 10 Things to Remember.

The Portico system (St. Jude Medical, Minneapolis, MN, USA) consists of a self-expanding valve prosthesis and a delivery system designed for transcatheter aortic valve replacement (TAVR). We describe this system, its 10-steps implantation procedure, and provide tips and tricks based on our personal experience with this system.

Retrograde Snare Technique to Overcome Hostile Aortic Arch Anatomy During Transcatheter Aortic Valve Implantation.

Percutaneous valve implantation is a recognized therapy for calcific aortic stenosis in those patients who are inoperable or at high surgical risk. The transfemoral approach is the most frequently used method for device delivery, but a tortuous calcific aorta and the inflexibility of large-caliber endovascular equipment can impede progress or even cause the procedure to be abandoned. Herein, the use of a technique employing a snare to safely overcome device obstruction in the aortic arch of an elderly female patient is described. The technique may be of practical value whenever any large-caliber device is obstructed in the circulation.

Femoral access-related complications during percutaneous transcatheter aortic valve implantation comparing single versus double Prostar XL device closure.

OBJECTIVES: To evaluate the efficacy and safety of a double Prostar XL suture-based closure technique compared to a conventional single Prostar XL technique in elective transcatheter aortic valve implantation (TAVI) via the common femoral artery. BACKGROUND: TAVI is recommended as a treatment for symptomatic severe aortic stenosis for those who are at high or prohibitive risk of surgical valve replacement. Vascular complications remain the most frequent category of procedural complication. The most efficacious and safest percutaneous suture-based closure technique is unknown. METHODS: Prospective observational study of Prostar XL device closures used in 126 consecutive patients between 2012 and 2014. Single Prostar XL closure was used in 63 patients and double Prostar XL closure in a further 63 patients. Outcomes from the groups were compared. All patients were treated transfemorally through an 18Fr sheath. Technical success was defined as hemostasis not requiring interventional or surgical repair during hospital admission. Bleeding and vascular complications were defined using the second consensus of the valvular academic research consortium (VARC-2) criteria. RESULTS: The cohort was aged 83+/-6 and 48% were female with a logistic Euroscore of 24+/-11.6. Technical success was 86% and 98% respectively (P = 0.017) with systematic single and double Prostar XL closure. Composite VARC-2 vascular and bleeding complications occurred more frequently in the single Prostar XL group compared to the double Prostar XL group (10 [16%] v 3 [5%] P < 0.04, and 17 [27%] v 6 [10%] P < 0.004). CONCLUSION: A systematic double Prostar XL closure technique for large caliber arterial access sites during TAVI is feasible, safe and associated with fewer technical failures, fewer vascular complications, and less bleeding compared with single Prostar XL.

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

Aim: 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. Methods: 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. Results: 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™. Conclusion: 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.