Long-term follow-up of percutaneous secundum-type atrial septal defect closure using Amplatzer Septal Occluder since 1995: a single-centre study.

INTRODUCTION: The goal of this single-centre study was to evaluate long-term results of percutaneous closure of secundum-type atrial septal defect using Amplatzer Septal Occluder with the follow-up to 25 years. METHODS: A retrospective analysis of patients who underwent percutaneous closure of secundum-type atrial septal defect between September 1995 and October 2012 in our institution was performed. All procedures were performed after fulfilling strict indication criteria. More than 5 years follow-up was reached in 651/803 patients (81%) with median follow-up time of 12 (5-25) years. RESULTS: The mean stretched defect diameter was 14,0 ± 5,2 mm. Early reintervention due to moderate or severe residual atrial septal defect had to be performed in 3/803 patients (0,03%). The incidence of long-term moderate or severe residual atrial septal defect was 0,0%. The complete closure rate at 10-year follow-up was 98,5%, as trivial residual shunts persisted in 8/508 patients (1,5%). A significant rate of the echocardiographic right ventricular end-diastolic diameter post-procedural normalisation (p < 0,05) was encountered. The rate of major complications was 0,5%. One device embolisation, one thrombus formation at the occluder surface, and one cardiac erosion in periprocedural or short post-procedural course were experienced. Only one late complication of infective endocarditis at the region of implanted occluder and the aortic valve was detected. The survival rate of all followed patients was 100%. CONCLUSIONS: Percutaneous closure of secundum-type atrial septal defect using Amplatzer Septal Occluder is a safe and effective procedure accounting for a very low incidence of major complications in the long-term follow-up.

Novel repair of acute Stanford type B aortic dissection using combined endovascular graft and transfemoral replacement of vascular plug.

We present successful treatment of dissected thoracoabdominal aorta using combined thoracic endovascular aortic repair and transfemoral replacement of Amplatzer™ vascular plug in a 38-year-old patient. Computed tomography angiography revealed a false lumen from the left subclavian artery to the left common iliac trunk, with re-entries connecting it to the true lumen of the aorta. We replaced the prosthetic endovascular graft just below the left subclavian artery to the top of the superior mesenteric artery. Amplatzer™ vascular plug was replaced below the diaphragm in a closed transfemoral procedure to prevent re-entry. The patient was discharged in good condition and 2 years postoperation imaging showed complete pseudoaneurysm closure.

Transcatheter atrial septal defect closure late after completion of biventricular circulation in patients with pulmonary atresia intact ventricular septum or critical pulmonary stenosis.

OBJECTIVE: This study aimed to explore anatomical and hemodynamic features of atrial septal defect, which was treated by transcatheter device closure late after completion of biventricular circulation in patients with pulmonary atresia and intact ventricular septum (PAIVS) or critical pulmonary stenosis (CPS). METHODS: We studied echocardiographic and cardiac catheterization data, including defect size, retroaortic rim length, single or multiple defects, the presence of malalignment atrial septum, tricuspid and pulmonary valve diameters, and cardiac chamber sizes, in patients with PAIVS/CPS who underwent transcatheter closure of atrial septal defect (TCASD), and compared to control subjects. RESULTS: A total of 173 patients with atrial septal defect, including 8 patients with PAIVS/CPS, underwent TCASD. Age and weight at TCASD were 17.3 ± 18.3 years and 36.6 ± 13.9 kg, respectively. There was no significant difference in defect size (13.7 ± 4.0 vs. 15.6 ± 5.2 mm, p = 0.317) and the retro-aortic rim length (3.7 ± 4.3 vs. 3.6 ± 0.3.1 mm, p = 0.948) between the groups; however, multiple defects (50% vs. 5%, p < 0.001) and malalignment atrial septum (62% vs. 14%. p < 0.001) were significantly frequent in patients with PAIVS/CPS compared to control subjects. The ratio of pulmonary to systemic blood flow in patients with PAIVS/CPS was significantly lower than that in the control patients (1.2 ± 0.4 vs. 2.0 ± 0.7, p < 0.001); however, four out of eight patients with atrial septal defect associated with PAIVS/CPS had right-to-left shunt through a defect, who were evaluated by the balloon occlusion test before TCASD. The indexed right atrial and ventricular areas, the right ventricular systolic pressure, and mean pulmonary arterial pressure did not differ between the groups. After TCASD, the right ventricular end-diastolic area remained unchanged in patients with PAIVS/CPS, whereas it significantly decreased in control subjects. CONCLUSIONS: Atrial septal defect associated with PAIVS/CPS had more complex anatomy, which would be a risk for device closure. Hemodynamics should be individually evaluated to determine the indication for TCASD because PAIVS/CPS encompassed anatomical heterogeneity of the entire right heart.

Percutaneous closure of a post-surgical ascending aortic pseudoaneurysm with an amplatzer septal occluder device and steerable guiding sheath.

Thoracic pseudoaneurysm in the ascending aorta is an uncommon condition associated with significant risk of morbidity and mortality. Treatment is recommended in all cases regardless of symptoms as the mortality rate if left untreated has been documented to be as high as 61%. The current standard of care for managing these lesions is open surgical repair. However, this is associated with significant morbidity. In-hospital mortality reported for patients undergoing surgical repair of an ascending aortic pseudoaneurysm ranges from 6.7% to 41%. When anatomically suitable, a less invasive approach using amplatzer vascular plug or septal occluder is an attractive approach. We present a case report of repair of a post-surgical ascending aortic false aneurysm using an amplatzer septal occluder with an Oscor ™ steerable guiding sheath; a novel approach to increase platform stability when engaging an aneurysm neck. Endovascular occluder deployment for closure of aortic false aneurysms remains a relatively novel technique. It is limited by the requirement to develop a stable endovascular platform to deliver the device and avoid system prolapse, particularly when accessing challenging lesions on the inner aortic curvature. We present the first case to utilize a steerable guiding sheath system to improve system stability and facilitate successful device delivery. Given the significant morbidity associated with open repair of these lesions we hope this will further expand the range of lesions viewed as appropriate for endovascular repair.

Efficacy and safety of atrial septal defect closure using Occlutech Figulla Flex II compared with Amplatzer Septal Occluder.

Few studies have reported the efficacy of Occlutech Figulla Flex II (FFII) device compared with Amplatzer Septal Occluder (ASO) device. The aim of this study was to examine the efficacy and safety of FFII compared with ASO for transcatheter atrial septal defect (ASD) closure. We retrospectively evaluated 190 patients using FFII and 190 patients using ASO who underwent transcatheter ASD closure. ASD characteristics were evaluated by transesophageal echocardiography. The prevalence of procedural complications, including erosion, device embolization, stroke, and new-onset atrial arrhythmia, and the presence of a residual shunt were evaluated between the two groups during 12-month follow-up. FFII was used more frequently than ASO in patients with a deficient aortic rim or septal malalignment (P = 0.02, P < 0.01, respectively). The procedural complications of erosion, device embolization, and stroke did not occur in any patients. New-onset atrial arrhythmia occurred in 3 patients of the FFII group and 4 patients of the ASO group, and the difference between the two groups was not significant (P = 0.70). A large residual shunt (≥ 3 mm) was observed in 6 patients of the FFII group and 5 patients of the ASO group, and the difference between the two groups was not significant (P = 0.76). FFII was used frequently in patients with high-risk ASD morphology; however, there was no difference in the prevalence of procedural complications or efficacy between patients using FFII and those using ASO.

Late recovery of the cardiopulmonary exercise capacity after transcatheter amplatzer device closures for atrial septal defects in adults.

Transcatheter atrial septal defect (ASD) closures using an Amplatzer Septal Occluder (ASO) have been widely performed. Compared to children, we sometimes experience late recovery of exercise performance in adult patients. Our study aimed to evaluate the change in the cardiopulmonary exercise capacity in asymptomatic or mildly symptomatic adult patients after a transcatheter ASD closure using an ASO. The subjects consisted of 29 patients (age 39.5 ± 13.6 years) that underwent cardiopulmonary exercise testing (CPX) before, 3, 6, and 12 months after a transcatheter secundum ASD closure using an ASO. The peak oxygen consumption (peak VO2), anaerobic threshold (AT), and slope of the correlation between the ventilation and carbon dioxide production (VE/VCO2 slope) were evaluated. We also evaluated the left-ventricular end-diastolic diameter (LVEDD), right-ventricular end-diastolic dimension (RVEDD) by echocardiography, and hemodynamic values by cardiac catheterization before the ASO procedure. The peak VO2 did not show any improvement 3 months after the ASO procedure; however, a significant improvement was displayed 6 and 12 months (baseline: 23.4 ± 6.3, 3 months: 23.6 ± 6.4, 6 months: 25.1 ± 5.6, 12 months: 26.4 ± 5.3 mL/kg/min; p < 0.001) after the ASO. The LVEDD (before: 38.1 ± 3.6, 3 months: 43.4 ± 3.4 mm; p < 0.001) and RVEDD (before: 33.6 ± 5.3, 3 months: 26.3 ± 2.6 mm; p < 0.001) on echocardiography quickly improved 3 months after the ASO. Although the LVEDD and RVEDD normalized 3 months after the ASO, the peak VO2 still decreased; however, the peak VO2 improved to almost a normal range 6 months after the ASO.

Perioperative changes in platelet count in patients with atrial septal defect.

BACKGROUND: Platelet count and function change following atrial septal defect (ASD) closure with the Amplatzer septal occluder (ASO). However, the clinical significance of these changes remains unclear. We examined changes in platelet count and mean platelet volume (MPV) before and after ASO placement, and the association between platelet count, MPV and various factors. We discussed the mechanism and clinical significance of changes in platelet count and MPV. METHODS: We evaluated 109 patients with ASD who underwent ASO placement, and we performed various analyses of platelet count and MPV. RESULTS: Younger patients typically had higher platelet counts and lower MPV on admission. They also had large ASDs relative to their body constitution; larger devices were therefore used. Rates of change in platelet count were higher in younger patients. There were no significant associations between platelet count or MPV before placement and mean pulmonary artery pressure, and Qp/Qs, and between the number of thrombocytopenia and presence or absence of headache or residual ASD. Platelet counts decreased on average by 21.3% for the first 3 days after ASO placement. One month after placement, platelet counts were slightly improved but remained lower than before placement. Conversely, MPV increased significantly after ASO placement and remained high a month after placement. The ASO size was the most influential factor in platelet count reduction after ASD closure by ASO. CONCLUSIONS: One month after ASO placement, platelet counts decreased and MPVs continued to increase, suggesting that platelet consumption and new production were still occurring a month after placement.

Transcatheter baffle leak closure via an amplatzer septal occluder in a senning-operated child.

Senning operation is a surgical treatment for transposition of great arteries that can be complicated by post-procedural atrial or caval baffle leaks. We present a 6-year-old boy with a history of Senning repair for transposition of great arteries, who developed a pulmonary venous baffle leak. Percutaneous baffle leak closure was successfully performed using an Amplatzer septal occluder.

A Long-Term Complication Occurred After Transcatheter Closure of Large Atrial Septal Defect.

Transcatheter closure of ostium secondum atrial septal defect has become an alternative method to surgical closure. However, the incidence of complications and long-term results of using large size (> 40 mm) Amplatzer septal occluders are unknown. This case reported a 59 years old woman, whom received transcatheter closure of atrial septal defect (36 mm) with a 40 mm Amplatzer septal occluder 10 years ago and was diagnosed with heart failure. Transthroacic echocardiography showed severe mitral valve regurgitation. Intra-operatively, we confirmed and removed the large device, but we found that the mitral annulus was badly damaged. Mitral valve replacement was performed. We believe large size devices need to be implanted cautiously, especially for the large defect with insufficient rims, and also routinely follow-up is necessary.

Three-dimensional echocardiographic demonstration of aortic wall erosion after percutaneous atrial septal defect closure.

Although late complications of percutaneous closure of atrial septal defect (ASD), including cardiac erosion and thrombosis, are rare, they are the most lethal. Data are still lacking regarding the usefulness of new imagining modalities, such as three-dimensional echocardiography (3DE), for the detection of these complications. Here, we report the case of a 57-year-old woman in whom cardiac erosion was very well visualized by 3D transesophageal echocardiography (3D TEE) after percutaneous ASD closure.

Relative Risk Factors for Cardiac Erosion Following Transcatheter Closure of Atrial Septal Defects: A Case-Control Study.

BACKGROUND: Transcatheter closure of secundum atrial septal defects (ASD) using the Amplatzer septal occluder is generally safe and effective, but erosion into the pericardial space or aorta has been described. Although the absolute risk of this complication is low, there has been no assessment of relative risk factors. METHODS AND RESULTS: All erosions reported to St. Jude Medical after ASD closure with an Amplatzer septal occluder (cases) were compared with controls (matched 2:1) who underwent ASD closure but did not develop an erosion. A total of 125 erosions were reported between 2002 and 2014, including 95 with an available echocardiogram. The median duration from implant to erosion was 14 days, but was >1 year in 16 patients. Nine patients (all age ≥17 years) who died were more likely to have an oversized device, and to have erosion into the aorta, than survivors. Aortic or superior vena cava rim deficiencies were more common in cases than in controls. In addition, larger balloon-sized ASD diameter, Amplatzer septal occluder device size, and device size-ASD diameter difference, and smaller weight:device size ratio were associated with erosion. On multivariable analysis, deficiency of any rim, device >5 mm larger than ASD diameter, and weight:device size ratio were associated with erosion. CONCLUSIONS: In addition to aortic rim deficiency, which was almost universal among erosion cases, there were several relative risk factors for erosion after ASD closure with the Amplatzer septal occluder device. To understand the mechanisms of and absolute risk factors for this uncommon but serious complication, an adequately powered prospective study with thorough echocardiographic evaluation will be critical.

One-stop shop assessment for atrial septal defect closure using 256-slice coronary CT angiography.

OBJECTIVES: To investigate the feasibility and accuracy of measurement of the pulmonary to systemic blood flow ratio (Qp/Qs) and defect and rim sizes in secundum atrial septal defects (ASDs) using 256-slice CT, compared to the reference transoesophageal echocardiography (TEE) and right heart catheterization (RHC) measurements. METHODS: Twenty-three consecutive adult patients with secundum ASDs who underwent retrospective ECG-gated coronary CT angiography (CCTA), TEE and RHC were enrolled in this study. Right ventricular (RV) and left ventricular (LV) stroke volumes (SV) were calculated by biventricular volumetry of CCTA. Qp/Qs-CT was defined as RVSV/LVSV. The sizes of the defect and rim were measured by multi-planar reconstruction CT images. Correlations between Qp/Qs-CT and Qp/Qs-RHC and between the defect diameter obtained by CT and TEE were analyzed by Pearson's coefficient analysis. Rim sizes by CT and TEE were compared by paired t-test. RESULTS: Qp/Qs-CT was significantly correlated with Qp/Qs-RHC (r = 0.83, p < 0.0001), and the defect diameter by CT was significantly correlated with that by TEE (r = 0.95, p < 0.0001). There was no significant difference between CT and TEE in measurements of rim size. CONCLUSIONS: 256-slice CCTA allows measuring Qp/Qs and size of defects and rims in patients with secundum ASDs, accomplishing pretreatment evaluation non-invasively and comprehensively. KEY POINTS: • Quantification of left-to-right shunting can be performed reliably and accurately by CT. • The sizes of defects and rims can be measured accurately using 256-slice CT. • 256-slice CT permits pretreatment evaluation of ASD non-invasively and comprehensively.

Coronary Sinus Defect Following Transcatheter Closure of ASD Using Amplatzer Septal Occluder: Potential Erosion by the Device.

We present a case of small coronary sinus defect detected after transcatheter device closure of a large secundum atrial septal defect. Although device erosion of the dilated coronary sinus is suspected, the defect in the coronary sinus may have been present prior to ASD device closure. Dilated coronary sinus may be a risk factor when closing a secundum ASD with a device. To the best of our knowledge, coronary sinus erosion by an ASD device has not yet been reported in the medical literature.

Displacement of Amplatzer septal occluder in a patient with atrial septal defects and an atrial septal aneurysm.

Transcatheter closure of atrial septal defects has become more common because of its high success rate and low morbidity; however, this treatment for patients with atrial septal aneurysms is still challenging.

Incomplete endothelialisation of an Amplatzer Septal Occluder device followed by meningitis and late acute bacterial endocarditis.

A 19-year-old woman with atrial septal defect treated percutaneously with an Amplatzer Septal Occluder 24 months earlier, who presented with a history of bacterial meningitis, was admitted with a diagnosis of endocarditis. After 6 weeks of treatment with antibiotics, the incompletely endothelialised occluder was surgically removed. The present report illustrates the need for long-term follow-up of patients who have received nitinol wire mesh occluders.

Transcatheter repair of aortic leaflet perforation in a patient with prior surgical bicuspid aortic valve repair.

A 47-year-old male underwent surgery for functional bicuspid aortic valve severe regurgitation with a fused right and left coronary cusp. The patient presents nine years after surgical bicuspid aortic valve repair with symptomatic severe aortic regurgitation, diagnosed by TEE and MRI, caused primarily from a perforation located at the base of the surgically fused coronary cusps. The patient had a minimally dilated aortic root that did not yet necessitate surgical intervention. We present a novel percutaneous bicuspid aortic valve perforation repair that potentially decreases the number of surgical operations the patient must undergo during his lifetime.

Midterm follow-up results of transcatheter treatment in patients with unroofed coronary sinus.

OBJECTIVE: We present the midterm results of transcatheter treatment of unroofed coronary sinus (CS) using the Amplatzer septal occluder. BACKGROUND: The unroofed CS is a rare atrial septal defect communicating the left atrium and CS. Surgery has been the mainstay of treatment. METHODS: In a 4.5-year period, nine patients (five males) with ages ranging from 26 to 69 years (median 39 years) diagnosed with an unroofed CS but without a persistent left superior vena cava (LSVC) underwent transcatheter treatment. Computerized tomography (CT) was performed in eight patients. Transesophageal echocardiography (TEE) was used to monitor the procedure. RESULTS: The mean Qp/Qs ratio was 2.4 ± 1 and mean systolic pulmonary artery pressure was 35 ± 19 mm Hg. An Amplatzer septal occluder was deployed in all nine patients. The device was implanted in the defect in one patient and at the CS ostium in the other eight patients. The median device size used was 22 mm (16-28 mm). The left disc herniated into the CS in the single patient in whom the device was implanted within the defect. All patients were available for the 3-month follow-up. None had a residual shunt on the 3-month follow-up echocardiography. One patient died of a stroke 4.5 months after the procedure. At mean follow-up of 42.6 ± 18.3 months, symptomatic improvement was documented in the remaining eight patients. All eight patients had an O2 saturation above 96%. CONCLUSION: Transcatheter treatment for unroofed CS without persistent LSVC using Amplatzer septal occluder is safe and feasible.

Cardiac myxoma following transcatheter closure of an atrial septal defect.

To date, no significant association has been reported between atrial septal defects (ASD) and cardiac myxomas. This study reports a 56-year-old woman with cardiac myxoma following transcatheter closure of ASD. She presented with a 3-month history of recurrent dizziness, vertigo, palpitations, and generalized weakness after undergoing ASD occlusion a year earlier. Echocardiography and cardiac computed tomography scans identified a large, mobile mass (7.2 cm × 2.8 cm) in the left atrium, protruding through the mitral valve. The patient underwent median sternotomy and pericardiotomy, and the histopathological examination confirmed the diagnosis of atrial myxoma. The current case illustrates the challenges in determining whether an atrial mass is a benign myxoma or a dangerous thrombus. While there is no definitive link between the implantation of an ASD closure device and the formation of a myxoma, the emergence of this tumor is a potential occurrence.