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Background. The optimal duration of antithrombotic therapy (ATT) after patent foramen ovale (PFO) closure remains under debate. This study sought to compare the clinical outcome of patients receiving antithrombotic agents for a short (6 months) versus extended (>6 months) period after the procedure. Methods. This was a retrospective cohort study using a propensity score matching analysis on 259 consecutive patients (131 males, 43 ± 10 years) undergoing PFO closure due to cryptogenic stroke, with complete follow-up (median duration of 10 [4–13] years). The outcome was compared between patients receiving short-term (Group short, N = 88) versus extended ATT (Group long, N = 171). Results. The PFO closure device was successfully implanted in all cases, with 3% of minor complications. After propensity score matching, there were no differences between Groups short and long in the rate of stroke (0.3 vs. 0.4% patient-year, p = 1.00 ), bleeding (2 vs. 2% patient-year, p = 0.17 ), and device thrombosis (0.3 vs. 0.1% patient-year; p = 0.60 ). Univariate analysis showed that short-term ATT was not associated with an increased risk of recurrent stroke (HR: 1.271 [95% CI: 0.247–6.551], p = 0.775 ) or prosthesis thrombus (HR: 0.50 [95% CI: 0.070–3.548], p = 0.72 ). Kaplan–Meier analysis revealed similar overall survival in Group short and long (100 vs. 99 ± 1%, respectively; p = 0.25 ). Conclusions. Short-term (6 months) ATT after PFO closure did not impair the clinical outcome, with a preserved low rate of recurrent stroke (0.3% patient-year) and device thrombosis (0.2% patient-year) at 10-year follow-up.

Introduction. Surgical closure of a large secundum atrial septal defect (ASD) with an absent superior or inferior rim is the standard method of management, but transcatheter closure of such a defect is possible and feasible. Objectives. To evaluate the feasibility, effectiveness, and safety of transcatheter closure of large secundum ASD with an absent superior or inferior rim through implantation of a cheatham platinum (CP) stent at the entrance of the superior vena cava (SVC) or inferior vena cava (IVC) into the right atrium (RA) to create a suitable rim for subsequent complete closure of the defect using a septal occluder. Patients and Methods. This case series was carried out at Ibn Al-Bitar Center for Cardiac Surgery, Baghdad, Iraq from 2014 to 2019, five patients underwent such transcatheter approach for closure of large secundum ASD with the absent superior or inferior rim by implantation of CP stent at the entrance of vena cave into the RA. Result. The ages and weights of patients who were enrolled in this study ranged from 9–31 years (15.2 ± 9 years) and 31.5–62 kg (42.6 ± 12 kg). Three patients had absent superior rims, and the other two had absent inferior rims. The Qp/Qs was ranged from 1.9–3.2 (2.78 ± 0.29), and the mean pulmonary arterial pressure ranged from 22–29 mmHg (25.4 ± 3 mmHg). The defects with an absent superior rim were closed successfully by implantation of CP stents of 45, 45, and 39 mm to create a rim which supported the left atrial disc of 30, 38, and 32 mm atrial septal occluder (ASO), respectively, while large secundum ASD with an absent inferior rim could be effectively closed by implantation of two overlapping bare CP stents of 45 mm to create an IVC rim that supported 34 mm and 30 mm atrial septal occluder. Conclusion and recommendation. Transcatheter closure of large secundum ASD with absent superior or inferior rim is possible and effective by implantation of covered and bare CP stents at the entrance of SVC and IVC, respectively. Although these procedures are relatively difficult and challenging, especially in the closure of large defects associated with absent inferior rim, they carry a high risk of stent migration (8 zig, 45 mm), so we recommend using a CP-stent (10 zig, 60 mm).

Background. Transcatheter closure of aneurysmal perimembranous ventricular septal defect (pmVSD), pmVSD near the aortic valve, and intracristal VSD (icVSD) with symmetrical or asymmetrical ventricular septal defect occluders still presents significant challenges. We report our experience with transcatheter closure of pmVSD and icVSD using Amplatzer duct occluder II (ADO II) in children. Method. We retrospectively analyzed all children, who presented to our hospital consecutively between March 2014 and June 2020 for attempted transcatheter closure of pmVSD or icVSD with the ADO II device. Standard safety and last-follow-up outcomes were assessed and compared. Results. In total, 41 patients underwent transcatheter closure of VSD with the ADO II (28 in pmVSD and 13 in icVSD groups) with a median age of 3.5 years (total range: 0.9 to 12 years) and median weight of 15.0 kg (total range: 10.0 to 43.0 kg). Implantation was successful in 40/41 patients (97.5%, 27/28 in pmVSD group, 13/13 in icVSD group). One patient with mild aortic valve prolapse in pmVSD group developed new-onset moderate aortic regurgitation after a 4/4 mm ADO II was deployed; however, this resolved after the device was retrieved and successfully replaced with a 5 mm zero eccentric VSD occluder. There was no procedure-related mortality. After a median follow-up of six months (total range: 6 to 72 months), complete closure rates were 85.1% and 76.9% among pmVSD and icVSD groups, respectively. In the pmVSD group, one case of new-onset moderate tricuspid regurgitation was observed at six months, and there was one case of severe tricuspid regurgitation that had progressed from mild tricuspid regurgitation at 12 months. No serious complications were noted in the icVSD group. Conclusion. ADO II provides a safe and reproducible alternative for the closure of perimembranous and intracristal ventricular septal defects with a diameter less than 5 mm in young children.

Objectives. This study aimed to explore the selection of views for transthoracic echocardiography-guided transfemoral puncture for the device closure of pediatric atrial septal defect (ASD) without radiation. Methods. Sixty children (29 males and 31 females) were diagnosed with a central ASD, normal heart function, and no other intracardiac deformity. All procedures were performed in a surgical operating room (without radiological equipment) under basic anesthesia; the femoral vein pathway and guidance by only transthoracic echocardiography were used to complete the device closure of the ASD. The subcostal acoustic window and parasternal aorta short-axis views were used to guide the extra stiff wire and catheter into the left atrium. All procedures were performed under the subcostal biatrial section. The sheath entered the left atrium, and the apical four-chamber view was used to monitor the delivery and release of the occluder. Results. Successful closure of the ASD was achieved in all cases. The operating time from the end of the puncture to the release of the occluder was 10.36 ± 3.57 minutes. No other incisions were needed in 60 cases. No occluders were removed, and no residual shunt or pericardial effusions were detected after the procedures, during the non-ICU stay time. The average hospital stay was 2.19 ± 0.58 days. Conclusion. The accurate selection of transthoracic echocardiographic views can better ensure the safety and effectiveness of ASD closure through the femoral vein without radiation in children.

Objectives. Patent ductus arteriosus (PDA) in elderly patients is an uncommon anomaly, and the duct itself is often calcified and fragile; therefore, transcatheter closure is more difficult. The aim is to analyse periprocedural and one-year follow-up results of transcatheter closure of PDA in such patients. Methods and results. Retrospective analysis of 33 elective patients aged ≥55 years (median 63; 56–85; 29 women), in whom PDA was closed percutaneously between 2002 and 2018 in two tertiary centres. All but three patients were symptomatic, with most in NYHA II (n = 14) and III (n = 11) class; pulmonary hypertension (n = 22), arterial hypertension (n = 22), duct calcifications (n = 17), atrial fibrillation (n = 15), significant mitral regurgitation (n = 5), and decompensated renal failure (n = 2) were observed. Different devices were applied depending on PDA morphology; nitinol wire mesh occluders with symmetrical articulating discs have been the most used in recent years (n = 11). Follow-up was conducted at an outpatient clinic (28/33 patients). The procedure was successful in all patients. There was one embolisation, followed by implantation of a larger device. No major complications were noted. A small residual shunt was present in echocardiography in one patient after one year. NYHA class improved in all but two patients (with multiple comorbidities). Conclusions. Transcatheter PDA closure in elderly patients is safe and efficient with a high complete closure rate and few complications. Amplatzer duct occluder type II is an attractive device in such patients.

Background. To evaluate the feasibility of using a single device to close multiple atrial septal defects (ASDs) under the guidance of transthoracic echocardiography (TTE) and with the aid of three-dimensional (3D) printing models. Methods. Sixty-two patients with multiple ASDs were retrospectively analyzed. Thirty of these patients underwent TTE-guided closure (3D printing and TTE group) after a simulation of occlusion in 3D printing models. The remaining 32 patients underwent ASD closure under fluoroscopic guidance (conventional group). Closure status was assessed immediately and at 6 months after device closure. Results. Successful transcatheter closure with a single device was achieved in 26 patients in the 3D printing and TTE group and 27 patients in the conventional group. Gender, age [18.8 ± 15.9 (3–51) years in the 3D printing and TTE group; 14.0 ± 11.6 (3–50) years in the conventional group], mean maximum distance between defects, prevalence of 3 atrial defects and large defect distance (defined as distance ≥7 mm), and occluder size used were similarly distributed between groups. However, the 3D printing and TTE group had lower frequency of occluder replacement (3.8% vs 59.3%, p<0.0001), prevalence of mild residual shunts (defined as p<0.05) and at 6 months (7.7% vs 29.6%, p<0.05) after the procedure, and cost (32960.8 ± 2018.7 CNY vs 41019.9 ± 13758.2 CNY, p<0.01). Conclusion. The combination of the 3D printing technology and ultrasound-guided interventional procedure provides a reliable new therapeutic approach for multiple ASDs, especially for challenging cases with large defect distance.

Aortic pseudoaneurysms can commonly be caused by previous thoracic surgery, trauma, and infection, quickly becoming life-threatening if ruptured. This pathology is typically asymptomatic and incidentally found on imaging; however, few cases have outlined hemoptysis as a presenting symptom for aortic pseudoaneurysms. Traditionally, management of these patients included surgical correction; however, percutaneous approaches have emerged as a safe alternative, helping to reduce the risk of morbidity and mortality associated with surgical correction. This report seeks to describe a case in which hemoptysis was the symptom unveiling the finding of a thoracic ascending aortic pseudoaneurysm and the use of an Amplatzer atrial septal defect (ASD) occlusion device as a viable option to safely resolve the disease process.

Objectives. To assess the long-term safety and efficacy of the Occlutech® ACCELL® Flex II device used for atrial septal defect (ASD) closure. This device differs from the regular device by having two very thin patches that are made of polyethylene terephthalate (PET). These patches enhance faster sealing of the defect. Background. Transcatheter closure has become the method of choice to manage most patients with secundum ASDs. There are different types of devices. The regular Occlutech device used to close an ASD is called the Occlutech Figulla Flex II. A newer modification of this device (Occlutech® ACCELL® Flex II) has been designed to eliminate/reduce thrombus formation and to enhance faster sealing. Methods. Thirty patients were followed up after occlusion of secundum ASD using the Occlutech® ACCELL® Flex II Device. The follow-up period ranged from 5.2–5.5 years with median of 5.3 years. Detailed history and full clinical examination, twelve-lead electrocardiogram (ECG), plain chest radiograph, and full 2D transthoracic echocardiography (TTE) were performed at discharge, at one month, six months, and yearly thereafter. Results. The mean age of the study group at the last follow-up was 10.4 ± 4.6 years, with 63.3% (nineteen patients) females. There were no residual shunts or complications encountered immediately after the procedure and at the latest follow-up. Conclusion. This study confirmed the transcatheter closure (TCC) of secundum ASDs using the Occlutech® ACCELL® Flex II device to be safe and effective with no complications detected in children and adolescents.

Background. Observational studies have shown percutaneous patent foramen ovale (PFO) closure to be a safe means of reducing the frequency and duration of migraine. Objective. This study evaluated the efficacy and safety of PFO closure in patients with migraine using evidence-based medicine. Methods. The Pubmed (MEDLINE), Embase, and Cochrane Library databases were searched for randomized controlled trials (RCTs), cohort studies, and retrospective case series from January 1, 2001, to February 30, 2021. The Jadad scale and R 4.1.0 software were used to assess the quality of the literature and meta-analysis, respectively. Results. In total, three randomized controlled trials, one pooled study, and eight retrospective case series including 1,165 participants were included in the meta-analysis. Compared with control intervention in migraine, PFO closure could significantly reduce headache frequency (OR = 1.5698, 95% CI: 1.0465–2.3548, p = 0.0293 ) and monthly migraine attacks and monthly migraine days (OR = 0.2594, 95% CI: 0.0790–0.4398, p = 0.0048 ). Subgroup analysis of patients who all completed PFO surgery showed resolution of migraine headache for migraines with aura (OR = 1.5856, 95% CI: 1.0665–2.3575, p = 0.0227 ). Conclusions. Treatment with PFO closure could reduce the frequency of headaches and monthly migraine days and is an efficient treatment for migraine attacks with aura.

Background. With the rapid development of transcatheter techniques and instruments, transcatheter occlusion for patients with perimembranous ventricular septal defect (pVSD) and aortic valve prolapse (AVP) was constantly being tried, while the efficacy and safety of pVSD with AVP remain controversial. Objective. The aim of this study was to evaluate long-term efficacy and safety of transcatheter occlusion of pVSD with AVP. Methods. We retrospectively analyzed 164 children with pVSD and AVP who underwent transcatheter occlusion between January 2013 and November 2014. AVP was divided into 3 degrees according to right coronary leaflet morphology at end-diastole during aortic root angiography. Patient demographic and clinical data were collected. Results. There were 97 males and 67 females (median age, 40.0 (30.0–62.7) months; average weight, 16.94 ± 9.02 kg). Mild (n = 63), moderate (n = 89), and severe (n = 12) AVP success rates were 93.7%, 89.9%, and 58.3%, respectively. Immediately after procedure, there was no new-onset aortic regurgitation (AR) above trivial degree, residual shunt above mild degree, or complications requiring medication or operation, except for 1 patient who developed transient complete atrioventricular block. During follow-up, 1 mild AVP patient aggravated from mild to moderate AR and 1 moderate AVP patient aggravated from trivial to moderate AR. The new-onset AR in mild, moderate, and severe AVP was 2%, 1.8%, and 20%, respectively. AR disappeared in 17 patients. Residual shunt occurred in 9 patients after procedure, 4 of which disappeared during the follow-up period. No serious complications occurred in any patient during follow-up. Five-year cardiovascular event-free survival rates for mild, moderate, and severe AVP were 89.6%, 94.5%, and 80.0%, respectively. Conclusion. Transcatheter occlusion of pVSD with mild and moderate AVP has a high success rate and few complications, which is safe and effective in long-term follow-up. Transcatheter occlusion of pVSD with severe AVP has low success rates and high AR incidence. Therefore, transcatheter occlusion of pVSD with AVP is recommended for mild to moderate, but not severe, AVP.

Objective. We reported the 3-year follow-up results of initial clinical experience with the AbsnowTM device, a novel biodegradable occluder for percutaneous closure of atrial septal defect (ASD). Background. The AbsnowTM device is a total biodegradable septal occluder with double-disc poly-L-lactic acid (PLLA) framework and PLLA membranes intergraded into the device to ensure its biodegradability, clinical safety, and efficacy. Methods. Five pediatric patients were enrolled from May to June 2018 in our institution and were followed up for 3 years. A clinical evaluation and transthoracic echocardiography were performed at 24 hr, 1 month, 3 months, 6 months, 12 months, and yearly after implantation. Primary endpoints were a composite clinical success, comprising of clinical closure success and safety at the 36-month follow-up evaluation. Secondary endpoints included technical success, procedure success, closure success, and safety at each of the follow-up visits. Results. The median subject age was 3.6 years (range 3.1–6.5 years). The mean ASD diameter was (13.7 ± 2.9) mm. The median device size was 20 mm (range 14 to 24 mm). Technical and procedure success was achieved in 100% (5/5) of the patients. At 2-year follow-up, 3 of the 5 patients developed new-onset residual shunts and 2 of them reached a moderate degree. At 3-year follow-up, the residual shunt size increased over time in all the 3 patients, and 1 of them had right ventricular enlargement. All of the 5 patients were free from serious adverse events during the 3-year follow-up, with no device embolization, thromboembolization, or reintervention to the target defect. Conclusion. This 3-year follow-up result of initial experience with the biodegradable AbsnowTM device has demonstrated acceptable safety with no procedural complications. Notably, the high rate of residual shunt significantly affected its efficacy. The long-term safety and efficacy of the device should be further evaluated in a large cohort of patients in future studies.

Background: The age of candidates for device closure of atrial septal defect (ASD) has been increasing. Thus, concerns exist about dyspnea aggravation or atrial fibrillation development after device closure due to augmentation of left ventricular (LV) and left atrial (LA) preload. This study aimed to examine patterns and determinants of serial pulmonary arterial pressure and left ventricular filling pressure changes after device closure of ASD. Methods: Among the 86 consecutive patients who underwent percutaneous device closure of ASD, those without pre- or post-procedural Doppler data and end-stage renal disease were excluded. The clinical, transesophageal, and transthoracic echocardiographic findings of 78 patients were collected at baseline, one day post-procedure, and one year follow-up. Results: The mean age of study patients was 49.8 ± 15.0 years and the average maximal defect diameter and device size was 20.2 ± 6.0 mm and 23.8 ± 6.4 mm. Some patients (n = 21; 27%) exhibited paradoxically increased tricuspid regurgitant velocity (TRV) one-day post-procedure; they also were older with lower e’, glomerular filtration rate, and LV ejection fraction and a higher LA volume index. However, even in these patients, TRV deceased below baseline levels one-year later. Both E/e’ (9.0 ± 3.5 vs. 11.4 ± 4.3; p < 0.001) and LA volume index significantly increased immediately after device closure, but all decreased one-year later. Larger defect size and higher TRV were significantly correlated with immediate E/e’ elevation. Conclusion: In older, renal, diastolic and systolic dysfunctional patients with larger LA, scheduled for larger device implantation, peri-interventional preload reduction therapy would be beneficial.

Background. Left atrial appendage occlusion (LAAO) is performed in patients with nonvalvular atrial fibrillation to reduce the risk of ischemic stroke. The patients with a history of intracranial hemorrhage were excluded from the pioneer randomized controlled trials. The purpose of this systemic review was to evaluate the data from observational studies reporting the efficacy and safety of LAAO in patients with a history of intracranial hemorrhage. Methods. Ovid MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Web of Science Core Collection, Scopus, Global Index Medicus, and ClinicalTrials.gov data sources were utilized for data collection. Results. A total of 12 studies met the inclusion criteria that included seven retrospective observational and five prospective observational studies. A total of seven hundred and twenty-seven patients with a history of intracranial hemorrhage underwent percutaneous left atrial appendage occlusion. There were 11 events of recurrent intracranial hemorrhage, 12 ischemic strokes, 4 transient ischemic attacks, and 26 all-cause deaths. The duration of follow-up varied from 3 months to 3.6 years in the included studies. Conclusion. Left atrial appendage occlusion can potentially be an effective and relatively safe treatment option to reduce the risk of ischemic stroke in selected patients with nonvalvular atrial fibrillation patients and history of intracranial hemorrhage. Future prospective randomized trials are needed to validate this approach.

Background Device embolization is the most frequent procedural complication during transcatheter closure of congenital cardiac defects. Retrieval of an embolized device may often be complicated by failure to introduce the right atrial (RA) disk hub into the sheath or difficulty in securely grasping the hub pin of RA disk. We aimed to evaluate the efficiency and success rate of device retrieval using a novel double snare technique. Methods We reviewed retrieval procedures of embolized atrial septal defect (ASD) or left atrial appendage (LAA) occluder using double snare technique reported from five tertiary referral centers in Korea, Japan, and Uzbekistan. A total of 16 retrieval procedures in 15 patients were reported, including 14 patients who were planned for ASD device closure while 1 patient was planned for LA appendage occlusion. Results Retrieved devices included 15 ASD occluders from six different manufacturers and one Amplantzer cardiac plug. Success rate of retrieval procedure was 100% using the double snare technique. There were no complications related to device retrieval. Most (15/16, 93.8%) of these devices could be retrieved through their original delivery sheaths. In six patients for whom retrieval was unsuccessful with conventional single snare technique and switched to double snare technique, the retrieval time was shortened significantly (P = 0.004*) by using the double snare technique. Conclusions The double snare technique enables effective retrieval of various embolized devices. It abolishes the need of changing the sheath to a larger one in most patients.

Background Due the wide variability of left atrial appendage morphology left atrial appendage occlusion (LAAO) remains a challenging procedure. The steerable FuStar delivery sheath was designed to allow both, transseptal access and delivery of percutaneous devices. We here report the first-in-human experience of LAAO with the FuStar sheath. Methods Twenty patients (76.6 ± 8.4 years; 12 (60%) males; CHA2 DS2 -VASc score: 5.0 ± 2) with non-valvular fibrillation and contraindications to oral anticoagulation underwent LAAO with the LAmbre device using the FuStar steerable sheath (Lifetech Scientific Corp., Shenzhen, China) at two german centers. Results Successful device implantation was achieved in all patients (100%). No periprocedural complications were observed. Procedure time, fluoroscopy time, contrast media, and radiation dose were 23.4 min ± 9.2, 11.9 min ± 4.1, 96.2 mL ± 45.7, and 2718.4 cG*cm2 ± 3835.3, respectively. Conclusion This study demonstrates the feasibility and safety of the steerable FuStar sheath for LAAO.

Objectives To describe the multidisciplinary assessment of patent foramen ovale (PFO) with substantial right-to-left shunting (RLS) and medium-term follow-up after PFO closure for stroke or transient ischemic attack (TIA). Background PFO closure is a therapeutic option to prevent recurrent ischemic event in patients with cryptogenic stroke and TIA. The apparent lack of benefit seen in previous studies was in part due to the inclusion of patients with alternate mechanisms of stroke/TIA. However, the long-term follow-up results of RESPECT trial confirmed that PFO closure could reduce the recurrence rate of stroke compared to medical therapy. The obvious difference between RESPECT and the other studies is that RESPECT recruited more relevant patients with substantial RLS. Methods From May 2013 to October 2015, all subjects diagnosed as cryptogenic stroke or TIA with substantial RLS who underwent PFO closure at our institution were included. All patients underwent multidisciplinary assessment to exclude stroke/TIA with definite etiology. Baseline characteristics, clinical manifestations, procedural, and follow-up data were reviewed. Results A total of 219 consecutive patients with substantial RLS undergoing PFO closure were identified. There were no procedure-related deaths, strokes, or TIA. Mean follow-up was 2.0 ± 0.7 years. Early residual shunting was visible in 9 patients (4.1%); however, during follow-up, only 3 patients (1.4%) had residual RLS detected by contrast transthoracic echocardiography (cTTE). The annual risk of recurrent ischemic stroke or TIA was 0.457%. Conclusions PFO closure can be performed safely and effectively in patients with cryptogenic stroke or TIA. In selected patients with substantial RLS, following appropriate multidisciplinary assessment, excellent results with low incidence of recurrent events may be achieved.

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.

Objectives. To demonstrate safety and efficacy of using different generations of softer Amplatzer™ devices for ventricular septal defect (VSD) closure to avoid serious complications at follow-up. Background. Transcatheter closure of perimembranous ventricular septal defects (PmVSD) is a well-established procedure; however, it is associated with unacceptable incidence of complete heart block. Great advantages have been achieved by using softer devices for VSD transcatheter closure. The first and second generation of Amplatzer™ occluders (AVP II, ADO, and ADO II) seem to offer a safe and attractive alternative for this procedure. These devices can be delivered using either an arterial (retrograde) or venous (prograde) approach. Methods and Results. Patients with congenital PmVSD who underwent transcatheter closure using ADO, ADO II, and AVP II devices were included. Primary end point was to determine efficacy and safety of these generations of devices and to determine the incidence of complications at follow-up (complete AV block and aortic/tricuspid/mitral regurgitation). One hundred and nineteen patients underwent VSD closure at a median age of 5 years (8 months–54 years). During the catheterization, there were only minor complications and at follow-up of 36 ± 25.7 months (up to 99 months), the closure rate was high of 98.3% and freedom from AV block was 100%. Conclusions. The use of softer Amplatzer™ devices is a good alternative to achieve PmVSD closure safely with no risk of AVB during the procedure or at midterm follow-up.

Purpose. The Occlutech Figulla occluder has been proven safe and effective at midterm follow-up after percutaneous atrial septal defect (ASD) closure. We describe the safety and efficacy at long-term follow-up in adults. Methods. All consecutive adult patients that underwent ASD closure between 2008 and 2015 were included. All complications were registered. Residual left-to-right shunt (LRS) was diagnosed using color-Doppler transthoracic echocardiography (TTE). Right-to-left shunting was diagnosed using contrast TTE. Successful closure was defined as no LRS at follow-up. Results. In total, 166 patients (mean age 56.7 ± 16.1 years; 62% female) underwent percutaneous ASD closure using the Occlutech Flex I (70%) or Flex II (30%) device (diameter 24 mm; range 10–40 mm) under general anaesthesia and transoesophageal echocardiographic guidance. Long-term follow-up data were available for 144 patients (87%) with a mean follow-up of 5.9 ± 2.6 years, a total of 814 patient-years. During hospitalization, device embolization occurred in three patients (1.8%) with successful extraction in all. During the long-term follow-up, 15 patients (9.8%) suffered new-onset atrial fibrillation and stroke occurred in 2.1%. There was no residual LRS at 12-month follow-up. No device embolization occurred during the long-term follow-up. Conclusion. Percutaneous ASD closure using the Occlutech device appears to be safe at long-term follow-up with a high successful closure rate at one year.

Aims. To investigate the healing process and nickel release of the Hyperion occluder (Comed BV, Netherlands), as compared to the Amplatzer septal occluder (ASO) (St. Jude Medical Inc., St. Paul, MN, USA) in a chronic swine model. Background. Some long-term complications occurring after percutaneous atrial septal defect (ASD) closure may be partially associated with an inappropriate healing of the device and increased nickel release. There is no direct comparative study of different occluders for healing and nickel release. Methods. After percutaneous ASD creation, 12 pigs were implanted with 15 mm Hyperion (n = 6) and 15 mm ASO (n = 6) devices. After 1 month (n = 3 for each device) and 3 months (n = 3 for each device) of follow-up, device explantation was performed and healing was assessed using histopathological workup. Systemic and tissular nickel release was performed. Results. Implantation was successful in 100% without complications. Device coverage was observed as early as 1 month after implantation and was almost complete after 3 months. A granulation tissue with a predominantly mononuclear inflammatory reaction was observed in contact with nitinol wires while an inflammatory reaction was seen in contact with textile fibers. We found no statistically significant difference between the 2 devices whether for histological grading scores or systemic nickel release, regardless to follow-up duration. Conclusions. In this preclinical study, we demonstrated that Amplatzer septal occluder and Hyperion occluder were not significantly different for device healing and nickel release processes.

Objectives. We aimed to explore the radiologic characteristics and interventional strategies for perimembranous ventricular septal defect (pmVSD) with aneurysm. Methods. 257 patients who underwent transcatheter closure of pmVSD with aneurysm were included in our study. We retrospectively reviewed the left ventricular opening of the aneurysm (a), diameter of the midsegment of the aneurysm (b), and diameter of the right ventricular opening of the aneurysm (c). If there were multiple defects within the aneurysm, the largest defect was denoted as c1 and so forth. We developed a novel VSD classification method in which pmVSD with aneurysm was classified into three types (A, B, and C). When a >b ≥ c, it was classified as type A, when b > a ≥ c, it was type B, and when c > a ≥ b, it was type C; c/c1 described the relationship among defects. Results. All of the 257 cases of pmVSD with aneurysm were defined using left ventriculography: type A, 60, type B, 58, and type C, 139. Transcatheter closure was attempted in 244 patients and succeeded in 227 cases (success rate was 93.0%; 227/244). Forty symmetric VSD occluders and 13 asymmetric VSD occluders were used for type A aneurysm occlusion; 31 symmetric VSD occluders, 19 asymmetric VSD occluders, and one Amplatzer duct occluder II (ADOII) were used for type B; 59 VSD symmetric occluders, 59 asymmetric VSD occluders, three eccentric VSD occluders, and two ADOII were used for type C. Within 24 hours after procedure, 2.2% patients had postprocedural residual shunt, and 2.2% experienced malignant arrhythmia (including type II second-degree AVB, cAVB, and CLBBB). Two hundred and twelve patients completed follow-up (93%, 212/227). No new severe complications were reported during follow-up, except in one patient who underwent surgery (removal of the device, VSD repair, and tricuspid valvuloplasty) due to severe postprocedural tricuspid regurgitation. Conclusions. It is safe and effective to apply this method for the classification of pmVSD with aneurysm and its interventional strategy.

Aim. The feasibility and safety of performing the combined procedure of catheter ablation (CA) and left atrial appendage closure (LAAC) for atrial fibrillation (AF) have been reported by observational studies without controls. The aim of this study was to compare the procedural and long-term outcomes of combined procedures with isolated CA or LAAC. Methods and Results. This study included patients who underwent combined CA and LAAC (combined group), CA alone (CA-only group), or LAAC alone (LAAC-only group). Propensity score matching was used to select controls from the CA-only and LAAC-only groups. Each group contained 76 subjects. The procedures were successfully performed in all the patients. Procedure-related complications of the combined group included one pericardial effusion and two groin haematomas, which did not differ significantly with those of the CA-only group (3.9% vs. 2.6%, P=0.650) or the LAAC-only group (3.9% vs. 2.6%, P=0.650), respectively. The AF-free rate of the combined group was comparable with that of the CA-only group after a mean of 2 years follow-up (67.1% vs. 69.7%, P=0.727). Compared with the LAAC-only group, the combined group achieved similar complete occlusion rate at implant (94.7% vs. 93.4%) and at 45 days (82.9% vs. 85.5%). At the end of follow-up, ischemic stroke and bleeding events of the combined group were low (3.9%) and were comparable with those of the CA-only group (5.3%) and the LAAC-only group (2.6%). Conclusions. The combination of AF-CA and LAAC is safe and efficacious compared with single procedures alone.

Objective. To study the safety and efficacy of microtransesophageal echocardiography (micro-TEE) and TEE during percutaneous atrial septal defect (ASD) and patent foramen ovale (PFO) closure. Background. TEE has proven to be safe during ASD and PFO closure under general anaesthesia. Micro-TEE makes it possible to perform these procedures under local anaesthesia. We are the first to describe the safety and efficacy of micro-TEE for percutaneous closure. Methods. All consecutive patients who underwent ASD and PFO closure between 2013 and 2018 were included. The periprocedural complications were registered. Residual shunts were diagnosed using transthoracic contrast echocardiography (TTCE). All data were compared between the use of TEE or micro-TEE within the ASD and PFO groups separately. Results. In total, 82 patients underwent ASD closure, 46 patients (49.1 ± 15.0 years) with TEE and 36 patients (47.8 ± 12.1 years) using micro-TEE guidance. Median device diameter was, respectively, 26 mm (range 10–40 mm) and 27 mm (range 10–35 mm). PFO closure was performed in 120 patients, 55 patients (48.6 ± 9.2 years, median device diameter 25 mm, range 23–35 mm) with TEE and 65 patients (mean age 51.0 ± 11.8 years, median device diameter 27 mm, range 23–35 mm) using micro-TEE. There were no major periprocedural complications, especially no device embolizations within all groups. Six months after closure, there was no significant difference in left-to-right shunt after ASD closure and no significant difference in right-to-left shunt after PFO closure using TEE or micro-TEE. Conclusion. Micro-TEE guidance without general anaesthesia during percutaneous ASD and PFO closure is as safe as TEE, without a significant difference in the residual shunt rate after closure.

Background. Septal malalignment is related to erosion and device embolization in transcatheter closure of atrial septal defect (ASD), but limited information is available. Objectives. This study aimed to assess clinical significance of septal malalignment and to determine appropriate evaluation of ASD diameter, including the selection of device size. Methods. Four hundred and seventeen patients with ASD who underwent transcatheter closure were enrolled. Septal malalignment was defined as separation between the septum primum and the septum secundum on transesophageal echocardiography. Results. One hundred and eighty-four patients had septal malalignment. The frequency of septal malalignment increased with age reaching around 50% in adult patients. Septal malalignment was related to aortic rim deficiency. The distance of separation between the septum primum and the septum secundum was 5 ± 2 mm (range, 1–11 mm). In patients with septal malalignment, the ASD diameter measured at the septum primum was 19 ± 6 mm, while the ASD diameter measured at the septum secundum was 16 ± 6 mm. There was a difference of 4 ± 2 mm (range, 0–8 mm) between the ASD diameter measured at the septum primum and that measured at the septum secundum. For transcatheter closure, the Amplatzer Septal Occluder device size 2-3 mm larger and the Occlutech Figulla Flex II device size 4–7 mm larger than the ASD diameter measured at the septum primum were frequently used. During the study period, erosion or device embolization did not occur in all of the patients. Conclusions. Septal malalignment is highly prevalent in adult patients with aortic rim deficiency. The measurement of ASD diameter at the septum primum can be valuable for the selection of device size in patients with septal malalignment.

Backgrounds Long-term fate of patients submitted to patent foramen ovale (PFO) closure is still unclear. The aim of the study was to evaluate the incidence of atrial fibrillation (AF), aortic or atrial free wall erosion, device thrombosis (DT), new onset or worsening of mitral valve regurgitation (MVR), and recurrent cerebral ischemic events in the long-term follow up after intracardiac echocardiography (ICE)-aided PFO closure in a large population. Methods We reviewed the medical and instrumental data of 1,000 consecutive patients (mean age 47.3 ± 17.1 years, females) prospectively enrolled in 2 centres over a 13 years period (February 1999-February 2012) for R-to-L shunt ICE-aided catheter-based closure using different devices. Results Immediate success was 99.8%. Implanted devices were Amplatzer PFO Occluder in 463 patients (46.3%), Amplatzer ASD Cribriform Occluder in 420 patients (42.0%), Premere Occlusion System in 95 patients (9.5%), and Biostar Occluder in 22 patients (2.2%). On a mean follow-up of 12.3 ± 0.6 years (minimum 4- maximum 17 years), permanent AF occurred in 0.5%, DT was apparent in 0.5%, new onset or worsening of MVR was observed in 0.2%, whereas recurrent cerebral ischemic events were 0.8%. Occlusion rate was 93.8%. No aortic or atrial free wall erosion has been observed. Conclusion ICE-aided closure of PFO using different devices, appeared very safe and effective on very long-term follow up with low incidence of erosion, DT, recurrent ischemic events, MVR new onset or worsening, and permanent AF.

Introduction Percutaneous patent foramen ovale (PFO) closure by means of a septal occluder device (SOD) is a well-known therapeutic strategy for the secondary prevention of paradoxical embolic neurological events. The aim of this study was to provide long-term echocardiographic and clinical follow-up data on patients who had undergone percutaneous PFO closure with 2 different SOD. Methods We selected 2 groups of patients treated with 2 different SOD: Group A: 52 patients with an Amplatzer® PFO Occluder and Group B: 49 patients with a Figulla Flex® device. All patients underwent follow-up Bubble Test Transthoracic Echocardiography (BTTE) and clinical examination. The results were compared with those recently reported in a group of patients with similar characteristics, but that had been treated conservatively, which acted as a control group. Results The mean follow-up after PFO closure was 53 months. The Amplatzer® PFO Occluder and the Figulla Flex were used in 52 (51.5%) and 49 (48.5%) of patients, respectively. We found no significant difference in the rate of effective PFO closure between the devices: Amplatzer 91.4%, Figulla 93.9% (P = 0.71). One patient (1.0%) suffered a recurrent neurologic event. BTTE was positive (BTTE+) in 8 patients (8%), 5 with an Amplatzer, and 3 with a Figulla device (P = 0.516). Only 1 patient with BTTE+ had a recurrent TIA (12.5%). No significant relationship was found between device dimensions and BTTE+ (P = 0.062). In the control group (163 patients), the recurrence of neurologic events was 9.2% (15 events), that was significantly higher in respect to the patients who had undergone percutaneous closure of the PFO. Conclusions Percutaneous PFO closure was associated with a remarkably low risk of recurrent embolic neurological events, and no long-term device-related major complications. No statistically significant difference emerged between the 2 different SODs regarding BTTE positivity. Long-term follow-up showed that the recurrence of neurological events has been significantly higher in the group treated in a conservative way.

Objectives The purpose of this study was to compare the effectiveness of device closure with the transseptal puncture and standard technique in patients with patent foramen ovale (PFO) and ischemic events. Methods Eighty-two consecutive patients (men: 60 patients, mean age: 45.2 years) who underwent PFO closure with the Amplatzer PFO Occluder were enrolled. PFO closure with the transseptal puncture was performed in 22 patients (transseptal puncture technique, group I). In the remaining patients (n = 60), PFO closure was performed with the standard technique (group II). The co-primary end points were the incidence of significant residual shunt on follow-up transesophageal echocardiography (TEE) and a composite of death, stroke, transient ischemic attack (TIA), and peripheral embolism. Results Baseline characteristics were similar between the two groups. On TEE, despite similar grade of interatrial right-to-left shunt, shunt at rest/septal hypermobility was less common in group I than in group II (40.9% vs. 72.9%, P

Aim Over the past 2 decades, transcatheter occlusion of patent ductus arteriosus (PDA) with coils and the duct occluders evolved to be the procedure of choice. A new device, the Occlutech PDA® occluder (ODO) device has been designed. Herein, we aimed to evaluate the characteristics and short-term results of patients who underwent transcatheter closure of PDA using the ODO. Methods We reviewed the clinical records of 60 patients from different centers in Turkey between December 2013 and January 2016. The medical records were reviewed for demographic characteristics and echocardiographic findings. Device size was selected on the narrowest diameter of PDA. Results The median patient age was 2.5 years (6 months–35 years), and median PDA diameter was 2.5 mm (1.2–11 mm). Fifty-eight of 60 patients (96.6%) had successful ODO implantation. The occlusion rates were 37/58 (63.7%) at the end of the procedure, 51/58 (87.9%) at 24–48 hours post-procedure, and 57/58 (98.2%) on echocardiography at a median follow-up of 7.6 months. Conclusion Our results indicate that transcatheter closure of PDA using the ODO is effective. Larger studies and longer follow-up are required to assess whether its shape and longer length make it superior to other duct occluders in large, tubular, or window-type ducts. (J Interven Cardiol 2016;29:325–331)

Objectives To evaluate the mid-term outcomes after percutaneous closure of the secundum atrial septal defects (ASD) using the Figulla-Occlutech device (FOD). Background Transcatheter closure has become the method of choice for most patients with ASD. Although the FOD may have some advantageous characteristics there is a paucity of data on later outcomes after the use of this relatively new device. Methods Observational, single arm study including 200 non-consecutive patients who underwent ASD closure between 04/09 and 07/15 in 2 centers. Device performance, deployment technique, and immediate and mid-term outcomes were assessed. Results Median age and weight were 24 years (4–72) and 58 kg (15–92), respectively. Single defects were observed in 171 patients (median size of 19 mm). The remainder had multiple or multifenestrated defects. Implantation of FOD (median size of 24 mm) was successful in all (99%), but 2 patients (1 with deficient postero–inferior rim; 1 with a large ASD for the size of the child). Embolization with device retrieval occurred in 2 (1%). Median follow-up of 36 months was obtained in 172 patients. Serial echocardiographic assessment showed complete closure in all but 2 patients, in whom an additional small non-significant posterior defect was purposely left untouched. There have been no episodes of late arrhythmias, device embolization, cardiac erosion, endocarditis, thromboembolism, wire fracture, or death. Conclusions Transcatheter closure of ASDs in older children, adolescents, and adults using the FOD was highly successful in a wide range of anatomical scenarios with high closure rates and no complications in mid-term follow-up.

BACKGROUND Post-myocardial infarction (MI) ventricular septal defects (PIVSD) are an uncommon but life-threatening complication of acute MI. Although surgical closure has been the standard of care, mortality, and recurrence of VSD remain high even after emergent surgery. Transcatheter VSD closure (TCC) devices have become an alternative or adjunct to surgical closure. METHODS Online database search was performed for studies that included adults with PIVSD who underwent medical treatment (MT) alone, surgical closure (SC) (early or late), and TCC (early, late, or for post-surgical residual VSD). RESULTS Twenty-six studies were included with a total of 737 patients who underwent either MT (N = 100), SC (early (n = 167), late (n = 100)), and TCC (early (n = 176), late (n = 115), or post-surgical residual VSD (n = 79)). The 30-day mortality among MT group was 92 ± 6.3%, among SC was 61 ± 22.5% (early 56 ± 23%, late 41 ± 30%), and for all TCC patients was 33 ± 24% (early 54 ± 32.7%, late 16 ± 26%), and TCC for post-surgical residual VSD 11 ± 34.9%. The mortality among overall SC, overall TCC and early TCC groups was significantly lower as compared with the MT (P

Objective To evaluate the feasibility, efficacy, and safety of a fully biodegradable poly lactic acid (PLA)-based occluder for atrial septal defect (ASD) closure in an animal model. Methods ASDs, approximately 12-mm in diameter, were generated in sheep (n = 18) by needle puncture and balloon dilatation. For ASD closure, occluders were implanted by percutaneous transcatheter approach under echocardiographic guidance. Outcomes were evaluated by transthoracic echocardiography, electrocardiography, blood testing, and histology within the follow-up period ranging from 1 month to 2 years. Results All occluders were successfully implanted. During follow-up, no animal died; rectal temperatures, blood test results, and electrocardiograms were within normal ranges; and transthoracic echocardiograms, macroscopic studies, and histopathological and electron microscopic examination demonstrated that the occluders were well positioned, with no shifting, residual shunts, severe inflammation, thrombus formation, atrioventricular valve insufficiency, cardiac erosion or arrhythmias. The occluders gradually embedded into the endocardial tissue of the hosts with complete endothelialization and disk absorption at 12 months, and a distinct molecular weight decrease of the framework (to 9% of initial) at 24 months after implantation. Conclusions In a sheep model, the use of totally biodegradable occluders appears feasible, efficacious and safe for ASD closure. Studies in humans are ongoing.

To determine differences in right heart remodeling for patients with ASD who underwent surgical compared to device closure.Retrospective analysis of echo data of 121 adult patients with ASD from 2005 to 2015 performed prior to closure and within 6-8 weeks, 6 months, and 1 year post closure.121 patients with median age of 39 were studied. Patients who underwent device closure were older (46 vs 37 years, P 0.05) with smaller mean ASD size (1.9 cm vs 2.3 cm, P 0.05). We observed a similar and significant reduction in right heart parameters and PASP for both surgical and device closure groups on serial echos up to 1 year. Device closure was associated with preservation of TAPSE compared to surgical closure (reduction of 0.2 cm vs 0.6 cm, P 0.001). Younger adults with ASD intervention (40 years) had lower baseline PASP (33 mmHg vs 40 mmHg, P 0.05) compared to older adults (40 years). This difference persisted up to 1 year with no difference in rate of right heart remodeling. The effects of device closure with better preservation of TAPSE and S' compared to surgery were consistent within both groups of younger and older adults.Device and surgical closure of ASD both result in similar improvements in right heart parameters. However, device closure is associated with better preservation of TAPSE at 1 year post intervention. Intervention for older adults with ASD, when compared to younger ones, did not result in a difference in rate of right heart remodeling.

Objectives Main aim of our study to show that ADO II device can be used for the small ventricular septal defects successfully and safely with low complication rates in pediatric population. Background It is hard to find an ideal device to use for every VSD successfully. If inappropriate device was chosen; complication rate increases, procedure time gets longer that prolongs exposure to ionizing radiation. Therefore interventionalists are in the search for new ideal devices. Material Between the dates April 2011–October 2014, 21 VSD closures with ADO-II device. were performed. Twenty patients were included, age ranged between 4 months 18 years. Weight of the patients was between 5–76 kg. Results VSD diameter ranges between 2–6 mm (3.75 ± 1.25). VSD types were muscular in 2 patients, rest of them were perimembranous type. Most of the perimembranous defects (19/21) were aneursymatic and tunnel shaped. All the cases were successfully closed, no major complications were reported. There was no incidence of left bundle branch block, P-R prolongation, or complete heart block. Conclusion Considering perimembraneous ventricular septal defects as difficult and risky for percutaneous closure because of its proximity to aortic, atrioventricular valves and conduction tissue, we suggest that ADO II device can be safely and effectively used for such defects in particular if an aneurysm formation is present which is also compatible with the literature. (J Interven Cardiol 2015;28:479–484)

Background Left atrial appendage occlusion (LAAO) is a promising intervention for stroke prevention in patients with non-valvular atrial fibrillation (NVAF). Early outcomes following LAAO have been published in many studies with variable results. Objective This updated meta-analysis aims to provide a summary of the early outcomes of LAAO. Methods Medline/Pubmed, Ovid Journals, Clinical trials, Abstract meetings, Cochrane databases were searched from January 1st, 1999 to November 30th, 2016. Results This meta-analysis included 49 studies involving 12 415 patients. The median age was 73.5 years (IQR 72-75 years) and 43% were males. Hypertension and diabetes were present in 36% and 15% of the population, respectively. There was a prior history of stroke and congestive heart failure in 14% and 18% of the population, respectively. The median CHADS2 score was 2.9 (IQR 2.6-3.3) and the median HASBLED score was 3.3 (IQR 3-4). LAAO implantation was successful in 96.3% of patients (95.40-97.08, I2 = 76.1%). The pooled proportion of all-cause mortality was 0.28% (0.19-0.38, I2 = 0%). The pooled proportion of all-cause stroke was 0.31% (0.22-0.42, I2 = 9.4%), major bleeding requiring transfusion was 1.71% (1.13-2.41, I2 = 73.2%), and pericardial effusion was 3.25% (2.46-4.14, I2 = 79%). Sub analysis of randomized clinical trials comparing LAAO devices to warfarin showed lower mortality (P = 0.03) with similar bleeding risk (P = 0.20) with LAAO. Conclusions This meta-analysis concludes that LAAO occlusion is a safe and effective stroke prevention strategy in patients with NVAF.

AIM Left atrial appendage occlusion (LAAO) is a technique for preventing thromboembolism in patients with atrial fibrillation and a high risk of irreversible bleeding. In some patients, a spontaneous iatrogenic transseptal leak (ITL) remains after LAAO. The aim of this study was to assess the correlation between ITL incidence and the results of cardiac function tests in patients who underwent LAAO. METHODS AND RESULTS LAOO was performed in 62 consecutive patients using the Amplatzer Amulet. Before and 3 months after LAA occlusion, the 6-min walking distance (6MWD) test was performed in all patients and oxygen consumption assessment (VO2max ) was performed in 32. All patients had transesophageal echocardiography before and 3 months after LAAO to assess ITL incidence. The patients were divided according to the presence and absence of ITL and the subgroup of patients with heart failure (HF) were further analyzed. In patients with HF and ITL, an increased VO2max (12.8 ± 5.2 vs 15.3 ± 4.7; P

A significant body of data has emerged in the area of Percutaneous Left Atrial Appendage Occlusion (LAAO). In this article, we present an overview of the most notable publications along with a review of the most important publications on LAAO in 2016. We also present important historical data such as landmark clinical studies, review of most utilized occlusion devices, and important clinical studies that are underway.

Objectives To report procedural outcome of sequential occlusion of the left atrial appendage (LAA) and an interatrial septal communication and discuss possible indications. Background There are some patients who may have indications for both closure of patent foramen ovale (PFO) or atrial septal defect (ASD), as well as closure of the LAA. The optimal procedural strategy is not known. Methods A retrospective review of LAA and PFO/ASD cases at our center was performed. Demographic, echocardiographic, and procedural data were recorded. Results Closure of LAA and then PFO/ASD (Group I: 11 patients), closure of both in the same setting (Group II: 3 patients), and closure of the PFO/ASD and then the LAA (Group III: 3 patients) was performed in a total of 17 patients. Average age was 63.5 ± 9.8 years. Most patients were hypertensive with prior cerebrovascular event in 52.9% of patients. Procedural success was 100%. Procedural adverse events were 2 episodes of tamponade (in Group I after first LAA procedure) treated with pericardiocentesis and 1 access-site hematoma (Group II) treated conservatively. Conclusions Sequential (staged or during the same procedure) closure of the LAA and interatrial communications can be performed safely in a carefully selected patient population. This is also the first known report of LAA occlusion in patients with prior septal closure devices. (J Interven Cardiol 2014;27:414–422)

Background Advances in interventional techniques now allow for transcatheter treatment of some ventricular septal defects (VSD), although there remain concerns about adverse events. We performed a systematic review to look at outcomes and complications associated with transcatheter closure of VSD. Method A PubMed search for series in English on device closure of VSD from 2003 to June 2012 was performed. We excluded small series that were included in multicenter studies and patients who had acquired VSD following myocardial infarction. The random effects model was used to obtain pooled estimates of success and complications. Results A total of 37 publications comprising 4,406 patients with VSD (perimembranous = 3,758, muscular = 419, intracristal = 47, doubly committed subarterial = 36, multiple = 16, postsurgical = 123, unclassified = 7) were included in this analysis. The age of patients ranged from 3 days to 84 years. The pooled estimate of successful device implantation was 96.6% (95% CI: 95.7–97.5). The most common complication is residual shunt (pooled estimated 25.5%; 95% CI: 18.9–32.1). Others included valvular defects (pooled estimate 4.9%; 95% CI: 3.4–6.4) and arrhythmias (pooled estimate 10.6%; 95% CI: 8.4–12.7). Discussion and Conclusion Our analysis suggests that transcatheter device closure of VSD is safe and yields good results. The limitations of this study are difficulties in analyzing different devices individually, and segregating the different VSD types. Further stratification by type of VSD, age of patients, and prevention of complications is needed before this can be recommended for routine treatment. (J Interven Cardiol 2014;27:260–272)

Objectives To evaluate the efficacy and safety of the new device Amplatzer Duct Occluder II (ADO II) for the closure of coronary artery fistulae (CAF) with coronary anomaly. Background Transcatheter device closure is an alternative treatment for selective patients with CAF. The currently available reports regarding the closure of CAF with the ADO II are limited. Methods From April 1, 2011 to July 15, 2012, 5 patients (3 males and 2 females) aged from 3 years to 27 years old (median age 5 years old) underwent CAF closure with the ADO II. The immediate and short-term outcomes were evaluated. Results ADO II was deployed via the femoral vein (2 cases), femoral artery (1 case), brachial artery (1 case), and radial artery (1 case). There were no complications during all the procedures. The median fluoroscopy and procedural times were 20 and 39 minutes, respectively. Immediate trivial and mild residual shunt was present in one patient, respectively, but disappeared 24 hours after the procedure, and there was no recanalization at a median follow-up of 6 months. Conclusions The new device ADO II was safely deployed with complete resolution of CAF shunt with tortuous coronary artery to the drainage. The reduced sheath sizes and softer shape of this device allow for venous or arterial approach. The ADO II might be a preferable alternative device for closure of small-tortuous CAFs.

Patent Ductus Arteriosus is an important cause of morbidity and mortality in preterms. As birth weight decrease, risks increase. Main aim of our study is to emphasize the effectiveness and safety of percutaneous PDA closure even in extremely low birth infants.In our center between the dates June 2014-June 2016, PDA of 10 patients less than 1,000 gr were closed percutaneously. To the best of our knowledge this study includes the largest cohort of infants less than 1,000 g in the literature, that PDA of those were percutaneously closed.Symptomatic patients, less than 1,000 gr having PDA were included in the study. All have 3 times medical therapy for PDA closure but it did not work. PDA was decided to be contributor of this medical state of them. The mean patient age was 19.5 ± 7.2 days. The median weight was 950 (842-983) gr. Mean gestational age was: 26.3 ± 0.63 weeks. Mean PDA diameter was 1.9 ± 0.41 mm. Morphology of PDA:6 of them were conical and 4 of them were tubular. In all patients ADOII-AS device were used for PDA closure via venous route. No major complications were reported. Left pulmonary arterial stenosis was detected in 1 patient who was resolved in 6 months duration.We want to emphasize that in experienced centers percutaneous closure of PDA can be an alternative to surgery even in the extremely low birth weight babies.

This study set out to assess indications, feasibility, complications, and clinical outcome of percutaneous transcatheter device closure of atrial septal defects (ASDs) in infants with a bodyweight below 10 kg.Retrospective single center chart and echocardiography review study from 8/2005-12/2013. Twenty-eight children with ASD (13 female) with a median age of 1.15 years (0.2-2.8) and a median weight of 7.2 kg (4.5-9.9) were analyzed. Indications for early ASD closure were failure to thrive (n = 15, 54%), bronchopulmonary dysplasia (BPD) with supplemental oxygen dependency (n = 7, 25%), and genetic syndromes with suspected pulmonary hypertension (n = 12, 43%). Device implantation was successful in all patients without any periprocedural mortality or major complication. Clinical outcome after a median follow-up period of 2.1 years (0.25-7.3) revealed no residual shunt and a significant decrease of right ventricular volume load. Patients with pulmonary hypertension experienced a significant reduction of pulmonary artery/RV pressure. Patients also showed decreased supplemental oxygen dependency and less cardiac medications, but no significant "catch-up growth" in those with failure to thrive.Interventional ASD closure in children weighing less than 10 kg can be performed without any additional major risks and shows a favorable outcome, especially in selected patients with significant non cardiac co-morbidities.

Long-term fate of patients submitted to patent foramen ovale (PFO) closure is still unclear. The aim of the study was to evaluate the incidence of atrial fibrillation (AF), aortic or atrial free wall erosion, device thrombosis (DT), new onset or worsening of mitral valve regurgitation (MVR), and recurrent cerebral ischemic events in the long-term follow up after intracardiac echocardiography (ICE)-aided PFO closure in a large population.We reviewed the medical and instrumental data of 1,000 consecutive patients (mean age 47.3 ± 17.1 years, females) prospectively enrolled in 2 centres over a 13 years period (February 1999-February 2012) for R-to-L shunt ICE-aided catheter-based closure using different devices.Immediate success was 99.8%. Implanted devices were Amplatzer PFO Occluder in 463 patients (46.3%), Amplatzer ASD Cribriform Occluder in 420 patients (42.0%), Premere Occlusion System in 95 patients (9.5%), and Biostar Occluder in 22 patients (2.2%). On a mean follow-up of 12.3 ± 0.6 years (minimum 4- maximum 17 years), permanent AF occurred in 0.5%, DT was apparent in 0.5%, new onset or worsening of MVR was observed in 0.2%, whereas recurrent cerebral ischemic events were 0.8%. Occlusion rate was 93.8%. No aortic or atrial free wall erosion has been observed.ICE-aided closure of PFO using different devices, appeared very safe and effective on very long-term follow up with low incidence of erosion, DT, recurrent ischemic events, MVR new onset or worsening, and permanent AF.

We sought to evaluate the effect of increasing experience with left atrial appendage (LAA) closure on short-term outcome.Data regarding the impact of the learning curve of LAA closure-particularly regarding technical aspects of the procedure-are lacking.The present analysis represents first data from a single-center all-comer registry. The population was divided into 3 groups according to treatment time (group 1: patients 1-30; group 2: patients 31-60; group 3: patients 61-90).The mean age of the population was 77 years. Median CHA2 DS2 VASC Score and HAS-BLED were 5 (IQR 3-5) and 3 (IQR 3-4), respectively. Implantation success was 90% with a slight but not statistically significant increase during the course of the registry. Procedure time (75 [62-108] vs. 50 [43-66] vs. 47 [41-61] minutes; P 0.0001), fluoroscopy time (20 [15-30] vs. 11 [8-19] vs. 11 [9-18] minutes; P = 0.002), and contrast volume (105 [70-170] vs. 60 [50-75] vs. 50 [50-73] ml; P 0.0001) were reduced across the 3 groups. In-hospital complications decreased significantly (20 vs. 7% vs. 0%; P = 0.021). The compression grade of the occluder was chosen higher with increasing learning curve (15 [11-25] vs. 25 [17-29] vs. 21 [14-26] %; P = 0.05).With increasing operator experience the performance and safety of percutaneous LAA closure improved continuously.

Percutaneous patent foramen ovale (PFO) closure by means of a septal occluder device (SOD) is a well-known therapeutic strategy for the secondary prevention of paradoxical embolic neurological events. The aim of this study was to provide long-term echocardiographic and clinical follow-up data on patients who had undergone percutaneous PFO closure with 2 different SOD.We selected 2 groups of patients treated with 2 different SOD: Group A: 52 patients with an Amplatzer(®) PFO Occluder and Group B: 49 patients with a Figulla Flex(®) device. All patients underwent follow-up Bubble Test Transthoracic Echocardiography (BTTE) and clinical examination. The results were compared with those recently reported in a group of patients with similar characteristics, but that had been treated conservatively, which acted as a control group.The mean follow-up after PFO closure was 53 months. The Amplatzer(®) PFO Occluder and the Figulla Flex were used in 52 (51.5%) and 49 (48.5%) of patients, respectively. We found no significant difference in the rate of effective PFO closure between the devices: Amplatzer 91.4%, Figulla 93.9% (P = 0.71). One patient (1.0%) suffered a recurrent neurologic event. BTTE was positive (BTTE+) in 8 patients (8%), 5 with an Amplatzer, and 3 with a Figulla device (P = 0.516). Only 1 patient with BTTE+ had a recurrent TIA (12.5%). No significant relationship was found between device dimensions and BTTE+ (P = 0.062). In the control group (163 patients), the recurrence of neurologic events was 9.2% (15 events), that was significantly higher in respect to the patients who had undergone percutaneous closure of the PFO.Percutaneous PFO closure was associated with a remarkably low risk of recurrent embolic neurological events, and no long-term device-related major complications. No statistically significant difference emerged between the 2 different SODs regarding BTTE positivity. Long-term follow-up showed that the recurrence of neurological events has been significantly higher in the group treated in a conservative way.

The purpose of this study was to compare the effectiveness of device closure with the transseptal puncture and standard technique in patients with patent foramen ovale (PFO) and ischemic events.Eighty-two consecutive patients (men: 60 patients, mean age: 45.2 years) who underwent PFO closure with the Amplatzer PFO Occluder were enrolled. PFO closure with the transseptal puncture was performed in 22 patients (transseptal puncture technique, group I). In the remaining patients (n = 60), PFO closure was performed with the standard technique (group II). The co-primary end points were the incidence of significant residual shunt on follow-up transesophageal echocardiography (TEE) and a composite of death, stroke, transient ischemic attack (TIA), and peripheral embolism.Baseline characteristics were similar between the two groups. On TEE, despite similar grade of interatrial right-to-left shunt, shunt at rest/septal hypermobility was less common in group I than in group II (40.9% vs. 72.9%, P 0.010). The device was successfully implanted in all patients. On follow-up TEE, significant residual shunt was more common in group I than in group II (28.6% vs. 4.3%, P = 0.021). In addition, composite of death, stroke, TIA, or peripheral embolism was more common in group I than in group II (13.6% vs. 0%, P = 0.017) during the follow-up period (mean 25.4 months).Compared to the standard technique, PFO closure with the transseptal puncture technique showed higher incidence of residual shunt and ischemic events. Therefore, this technique might be considered in only highly selected patients as the last option.

Over the past 2 decades, transcatheter occlusion of patent ductus arteriosus (PDA) with coils and the duct occluders evolved to be the procedure of choice. A new device, the Occlutech PDA® occluder (ODO) device has been designed. Herein, we aimed to evaluate the characteristics and short-term results of patients who underwent transcatheter closure of PDA using the ODO.We reviewed the clinical records of 60 patients from different centers in Turkey between December 2013 and January 2016. The medical records were reviewed for demographic characteristics and echocardiographic findings. Device size was selected on the narrowest diameter of PDA.The median patient age was 2.5 years (6 months-35 years), and median PDA diameter was 2.5 mm (1.2-11 mm). Fifty-eight of 60 patients (96.6%) had successful ODO implantation. The occlusion rates were 37/58 (63.7%) at the end of the procedure, 51/58 (87.9%) at 24-48 hours post-procedure, and 57/58 (98.2%) on echocardiography at a median follow-up of 7.6 months.Our results indicate that transcatheter closure of PDA using the ODO is effective. Larger studies and longer follow-up are required to assess whether its shape and longer length make it superior to other duct occluders in large, tubular, or window-type ducts. (J Interven Cardiol 2016;29:325-331).

Background: Data on closure of atrial septal defects (ASD) in elderly patients with a fenestrated Amplatzer septal occluder (ASO) device is limited. Methods: A hemodynamically significant ASD was closed with a fenestrated ASO in 3 patients with ages >62 years. Prior to implant a 4-mm fenestration was created by balloon dilatation without additional suture fixation just adjacent to the stent part of the device. Indications for fenestration were restrictive left ventricular physiology and/or pulmonary hypertension. Heparin had been administered during and for 48 hours after the procedure. Two patients were maintained on phenprocoumon because of chronic atrial fibrillation, the remaining patient on aspirin and clopidogrel for 3 months after implant. Transesophageal echocardiography (TEE) and hemodynamic evaluation were performed 4–18 months after ASD closure. Results: A trace or small fenestration through the ASO with left-to-right shunt was detected by TEE in all 3 patients without any hemodynamic significance. No thrombus formation was observed. Pulmonary hypertension improved in the affected patient. Pulmonary arterial wedge pressure and cardiac index improved in the second patient with improvement in heart failure symptoms and of quality of life in both. The third patient, after initial improvement for 6 months, developed significant comorbidities and clinical deterioration at 18 months follow-up. Conclusion: The modified fenestration of the ASO decreased significantly in size at follow-up. Applying this technique to selected patients judged to be at risk for ASD closure avoids acute decompensation and allows gradual diminuition of right ventricular volume overload during mid-term follow-up. (J Interven Cardiol 2011;24:485–490)