Aortic iatrogenic perforation during transseptal puncture and successful occlusion with Amplatzer ductal occluder in a case of mitral paravalvular leak closure.

Complications of transseptal puncture are significant and potentially life threatening. Aortic perforation is one of these complications and it needs to be repaired immediately. We report the case of a 48-year-old female with a history of rheumatic mitral valve disease. She underwent three previous mitral valve replacements. Her last echocardiogram reported an anterolateral leak in the mitral prosthesis. Catheterization was performed. During the procedure, when attempting to perform transseptal puncture, catheterization was complicated by a forcefully puncture of the aortic root by the Brockenbrough needle followed by an immediately advancement of an 8-Fr Mullins sheath. We decided to leave the 8-Fr sheath in the aortic root recognizing the danger of removing the sheath and finally we advanced a 6/4 mm Amplatzer ductal occluder (ADO I) through the Mullins sheath and under fluoroscopy and TEE guidance we achieved a successful deployment of the device and closure of the perforation. Subsequently, the paravalvular leak was closed with an Amplatzer Vascular Plug (AVP III 10/5 mm). There are only three cases of a similar technique for the same injury in which the authors describe successful closing of aortic perforation with percutaneous closure devices. Our case is the first described during a mitral paravalvular leak closure. It is also the first to describe a different technique of leaving the Mullins sheath in the aortic root and advancing the Amplatzer device through it to achieve successful closure of the aortic perforation. We preferred the percutaneous closure over open-heart repair. © 2015 Wiley Periodicals, Inc.

Long-Term Outcomes of Pharmacoinvasive Strategy Versus Primary Percutaneous Coronary Intervention in ST-Elevation Myocardial Infarction: A Study from Mexico City.

Although primary percutaneous coronary intervention (pPCI) is the treatment of choice in ST-elevation myocardial infarction (STEMI), challenges may arise in accessing this intervention for certain geodemographic groups. Pharmacoinvasive strategy (PIs) has demonstrated comparable outcomes when delays in pPCI are anticipated, but real-world data on long-term outcomes are limited. The aim of the present study was to compare long-term outcomes among real-world patients with STEMI who underwent either PIs or pPCI. This was a prospective registry including patients with STEMI who received reperfusion during the first 12 hours from symptom onset. The primary objective was cardiovascular mortality at 12 months according to the reperfusion strategy (pPCI vs PIs) and major cardiovascular events (cardiogenic shock, recurrent myocardial infarction, and congestive heart failure), and Bleeding Academic Research Consortium type 3 to 5 bleeding events were also evaluated. A total of 799 patients with STEMI were included; 49.1% underwent pPCI and 50.9% received PIs. Patients in the PIs group presented with more heart failure on admission (Killip-Kimbal >I 48.1 vs 39.7, p = 0.02) and had a lower proportion of pre-existing heart failure (0.2% vs 1.8%, p = 0.02) and atrial fibrillation (0.25% vs 1.2%, p = 0.02). No statistically significant difference was observed in cardiovascular mortality at the 12-month follow-up (hazard ratio for PIs 0.74, 95% confidence interval 0.42 to 1.30, log-rank p = 0.30) according to the reperfusion strategy used. The composite of major cardiovascular events (hazard ratio for PIs 0.98, 95% confidence interval 0.75 to 1.29, p = 0.92) and Bleeding Academic Research Consortium type 3 to 5 bleeding rates were also comparable. A low socioeconomic status, Killip-Kimball >2, age >60 years, and admission creatinine >2.0 mg/100 ml were predictors of the composite end point after multivariate analysis. In conclusion, this prospective real-world registry provides additional support that long-term major cardiovascular outcomes and bleeding are not different between patients who underwent PIs versus primary PCI.

Pulmonary arterial hypertension in children with congenital heart disease: a deeper look into the role of endothelial progenitor cells and circulating endothelial cells to assess disease severity.

Endothelial progenitor cells and circulating endothelial cells have been proposed as useful markers of severity and disease progression in certain vascular diseases, including pulmonary arterial hypertension. Our study focused on evaluating the levels of circulating endothelial progenitor cells and circulating endothelial cells in patients with congenital left-to-right shunts and pulmonary hypertension undergoing definitive repair. Endothelial progenitor cells (identified by simultaneous co-expression of CD45dim, CD34 + and KDR2 + surface antibodies) and circulating endothelial cells (identified by simultaneous co-expression of inherent antibodies CD45-, CD31+, CD146 + and CD105+) were prospectively measured in seventy-four children (including children with Down syndrome), median age six years (2.75-10), with clinically significant left-to-right shunts undergoing transcatheter or surgical repair and compared to thirty healthy controls. Endothelial progenitor cells and, particularly, circulating endothelial cells were significantly higher in children with heart disease and pulmonary arterial hypertension when compared to controls. Endothelial progenitor cells showed significant correlation with pulmonary vascular resistance index when measured both systemically (r = 0.259; p = 0.026) and in the superior vena cava (r = 0.302; p = 0.009). Children with Down syndrome showed a stronger correlation between systemic cellularity and pulmonary vascular resistance index (r = 0.829; p = 0.002). Endothelial progenitor cells were reduced along their transit through the lung, whereas circulating endothelial cells did not suffer any modification across the pulmonary circulation. In children with yet to be repaired left-to-right shunts, endothelial progenitor cells and circulating endothelial cell counts are increased compared to healthy subjects.

Transcatheter closure of paravalvular leaks: short- and medium-term outcomes.

Background: Paravalvular leak (PVL) is a frequent and important complication after surgical valvular replacement that can cause heart failure and hemolytic anemia and is associated with poor clinical outcomes. Surgical reoperation has been the standard treatment, but it is associated with high morbidity and mortality. Transcatheter closure is a therapeutic alternative. The aim of the present study is to analyze the feasibility and the short- and medium-term outcomes of the transcatheter closure of PVLs. Methods: Single-center registry of consecutive patients with post-surgical PVLs that underwent transcatheter closure, between January 2006 and December 2016. Efficacy and safety results were analyzed during the procedure and at 6-month follow-up. Results: Twenty-one PVLs (15 mitral, 5 aortic, and 1 tricuspid) were closure during 20 procedures. In the initial echocardiography, 91% of the leaks were severe. The most used device was the Amplatzer Vascular Plug III® in 10 procedures (50%). The three-dimensional transesophageal echocardiography was used in 70% of cases. The device was successfully implanted in 95% of cases, a regurgitation reduction ≥ 1 grade was achieved in 95% of the cases, and the clinical success was 79%. Six-month survival was 100%; however, three cases required valvular surgery (15%). Conclusions: Transcatheter closure of PVLs is a feasible and safe procedure with high rates of technical, echocardiographic, and clinical success in the short and medium term. It is an adequate therapeutic alternative, mainly in high surgical risk patients and multiples comorbidities.

Introducción: La fuga paravalvular es una complicación frecuente e importante posterior al reemplazo valvular quirúrgico que puede ocasionar insuficiencia cardiaca, anemia hemolítica y se relaciona con malos resultados clínicos. La reintervención quirúrgica ha sido el tratamiento habitual, pero se acompaña de alta morbimortalidad. El cierre transcatéter es una alternativa terapéutica. El objetivo del presente estudio es analizar la factibilidad y los resultados a corto y mediano plazo del cierre transcatéter de fugas paravalvulares con dispositivos oclusores. Métodos: Registro unicéntrico de una serie consecutiva de pacientes con fugas paravalvulares posquirúrgicas que fueron cerradas vía transcatéter con dispositivos oclusores, entre enero del 2006 y diciembre del 2016. Se analizaron los resultados de eficacia y seguridad durante el procedimiento y a seis meses. Resultados: Se trataron 21 fugas paravalvulares (15 mitrales, 5 aórticas y 1 tricuspídea) durante 20 procedimientos. El 91% de las fugas fue grave en la ecocardiografía inicial. El dispositivo utilizado con más frecuencia fue el Amplatzer Vascular Plug III® en 10 procedimientos (50%). Se utilizó ecocardiografía transesofágica tridimensional en 70% de los casos. Se logró implantar el dispositivo con éxito en el 95% de los casos; se consiguió una reducción ≥ 1 del grado de regurgitación en el 95% de las veces y se alcanzó el éxito clínico en el 79%. A seis meses la supervivencia fue del 100%; sin embargo, tres casos requirieron cirugía valvular (15%). Conclusiones: El cierre transcatéter de fugas paravalvulares es un procedimiento factible, seguro y con tasas elevadas de éxito técnico, ecocardiográfico y clínico a corto y mediano plazo. Es una alternativa terapéutica adecuada, en particular en pacientes considerados de alto riesgo quirúrgico y múltiples comorbilidades.

Transcatheter closure of paravalvular leaks: short and medium-term outcomes.

Background: Paravalvular leak is a frequent and important complication after surgical valvular replacement that can cause heart failure, hemolytic anemia and is associated with poor clinical outcomes. Surgical reoperation has been the standard treatment, but it is associated with high morbidity and mortality. Transcatheter closure is a therapeutic alternative. The aim of the present study is to analyze the feasibility and the short and medium-term outcomes of the transcatheter closure of paravalvular leaks. Methods: Single-centre registry of consecutive patients with post-surgical paravalvular leaks, that underwent transcatheter closure, between January 2006 and December 2016. Efficacy and safety results were analyzed during the procedure and at 6-month follow-up. Results: 21 paravalvular leaks (15 mitral, 5 aortic and 1 tricuspid) were closure during 20 procedures. In the initial echocardiography 91% of the leaks were severe. The most used device was the Amplatzer Vascular Plug III® in 10 procedures (50%). The 3D transesophageal echocardiography was used in 70% of cases. The device was successfully implanted in 95% of cases, a regurgitation reduction ≥ 1 grade was achieved in 95% of the cases, and the clinical success was 79%. Six month survival was 100%; however, 3 cases required valvular surgery (15%). Conclusions: Transcatheter closure of paravalvular leaks is a feasible and safe procedure with high rates of technical, echocardiographic and clinical success in the short and medium term. It is an adequate therapeutic alternative, mainly in high surgical risk patients and multiples comorbidities.

Introducción: La fuga paravalvular es una complicación frecuente e importante posterior al reemplazo valvular quirúrgico que puede ocasionar insuficiencia cardiaca, anemia hemolítica y se relaciona con malos resultados clínicos. La reintervención quirúrgica ha sido el tratamiento habitual, pero se acompaña de alta morbimortalidad. El cierre transcatéter es una alternativa terapéutica. El objetivo del presente estudio es analizar la factibilidad y los resultados a corto y mediano plazo del cierre transcatéter de fugas paravalvulares con dispositivos oclusores. Métodos: Registro unicéntrico de una serie consecutiva de pacientes con fugas paravalvulares posquirúrgicas que fueron cerradas vía transcatéter con dispositivos oclusores, entre enero del 2006 y diciembre del 2016. Se analizaron los resultados de eficacia y seguridad durante el procedimiento y a seis meses. Resultados: Se trataron 21 fugas paravalvulares (15 mitrales, 5 aórticas y 1 tricuspídea) durante 20 procedimientos. El 91% de las fugas fue grave en la ecocardiografía inicial. El dispositivo utilizado con más frecuencia fue el Amplatzer Vascular Plug III® en 10 procedimientos (50%). Se utilizó ecocardiografía transesofágica tridimensional en 70% de los casos. Se logró implantar el dispositivo con éxito en el 95% de los casos; se consiguió una reducción ≥ 1 del grado de regurgitación en el 95% de las veces y se alcanzó el éxito clínico en el 79%. A seis meses la supervivencia fue del 100%; sin embargo, tres casos requirieron cirugía valvular (15%). Conclusiones: El cierre transcatéter de fugas paravalvulares es un procedimiento factible, seguro y con tasas elevadas de éxito técnico, ecocardiográfico y clínico a corto y mediano plazo. Es una alternativa terapéutica adecuada, en particular en pacientes considerados de alto riesgo quirúrgico y múltiples comorbilidades.

[Tetralogy of fallot and total anomalous pulmonary venous drainage to coronary sinus. Case report]. / Tetralogía de Fallot con conexión anómala total de venas pulmonares a seno coronario. Reporte de un caso con esta rara asociación.

We report the case of an infant 3 months old with a rare association, tetralogy of Fallot with total anomalous pulmonary veins connection the diagnosis was made by echocardiography and a successful complete reparation was achieved.

Treatment of seven patients with coarctation of the aorta treated using a Mexican-made platinum/iridium stent.

BACKGROUND: Nowadays, stenting is the treatment of choice in patients >15 years of age with coarctation of the aorta without hypoplastic aortic isthmus. The platinum/iridium stent manufactured in Mexico may be an affordable alternative with the same benefits as the imported stent. METHODS: This is a series of cases in which we present the immediate results of the first seven patients with coarctation of the aorta treated with the platinum/iridium stent manufactured in Mexico. The first four patients were selected and treated at the Cardiology Hospital of the National Medical Center during the year 2003, two more patients were selected and treated at the National Institute of Cardiology, and another patient was treated at the Military Hospital, Mexico City, in the year 2005. RESULTS: A total of seven patients were successfully treated with the platinum/iridium stent without any complications. Average initial gradient was 56.4 mmHg (range: 30-90 mmHg). In six patients, the final gradient was 0.0 mmHg and in one it was 2 mmHg. In the four patients treated in the Cardiology Hospital of the National Medical Center, mean follow-up time was 17.5 +/- 2.5 months, with a gradient of 0.0 mmHg. All patients are in NYHA Class I. At 12 months follow-up, the gradient remains as 0 mmHg and the patients are still in NYHA Class I functional state. CONCLUSIONS: This stent can be a safe and effective alternative to other stents available on the market for the treatment of coarctation of the aorta.

[Patent ductus arteriosus in the adult: transcatheher treatment immediate and medium term results]. / Conducto arterioso en el adulto: tratamiento transcateterismo. Resultados inmediatos y a mediano plazo.

INTRODUCTION: The anatomic changes of the patent ductus arteriosus (PDA) in adult patients, such as aortic aneurysm, calcification, or being short and sometimes friable, could complicate the surgical treatment. The transcatheter occlusion of PDA with different devices is currently accepted as safe and effective. We presented our experience with percutaneous occlusion of PDA in adult patients by means of three different devices. METHODS AND RESULTS: Between January 2000 and March 2005, 53 adult patients (47 women and 6 men) with PDA were treated for occlusion by means of percutaneous procedures. Average age was 25.3 years (Range, 16 to 54.7 years). Three different devices were used, 39 patients with Amplatzer for ductus arteriosus, 1 patient with Amplatzer for muscular interventricular communication, 11 with Gianturco coils, and 1 patient with Nit-Occlud. All devices were implanted successfully. Immediate complete closure was achieved in 31 patients (58.4%), in 20 patients (37.7%) with minimal leakage, and in 2 patients (3.89%) with moderate leak. Previous systolic pulmonary pressure had an average of 37.08 +/- 22.8. mm Hg (Range: 12-138 mm Hg) and went down to 28.75 +/- 10.25 mm Hg (Range: 16-57 mm Hg) with p d x 0.001. The average time follow-up was of 16.8 months (Range: 0.9 to 51.8 months) the occlusion was completed in 100%, in neither patients were observed complications related to implant of the devices. CONCLUSION: Transcatheter closure at PDA in adult patients with different devices is safe and feasible.

[Percutaneous closure of ductus arteriosus and muscular ventricular defect with amplatzer occluder in a patient with severe pulmonary hypertension]. / Cierre percutáneo de conducto arterioso y de comunicación interventricular muscular con dispositivos de Amplatzer en paciente con hipertensión pulmonar acentuada.

Surgical treatment of multiple muscular ventricular septal defects with associated lesions and severe pulmonary hypertension has a high morbility and mortality. Closure of these defects by the Amplatzer muscular VSD occluder is an alternative to surgery, avoiding the need of cardiopulmonary bypass. We present the case of a 38 year-old woman with signs of heart failure in NYHA functional class IV, with two muscular ventricular septal defects, patent ductus arteriosus and severe pulmonary hypertension, that were treated with three Amplatzer muscular VSD occluders, with significant reduction of pulmonary pressure and functional class improvement.

[Amplatzer® Vascular Plug III, for closing residual mitral paravalvular leak: three-dimensional transesophageal echocardiography image]. / Amplatzer® Vascular Plug III, para cierre de fuga paravalvular mitral residual: imagen de ecocardiograma transesofágico tridimensional.

Paravalvular leak is a significant complication after surgical valve replacement. Traditionally, redo surgery has been considered the treatment of choice, but is associated with high morbidity and mortality as well as increase risk of developing new leaks. Percutaneous treatment of paravalvular leak appears as an attractive alternative. Such treatment has been made possible by the current ability to integrate multiple imaging modalities that have helped to define the anatomy of the defect and planning and guiding the percutaneous closure procedure, thus resulting in better outcomes. The Amplatzer® Vascular Plug III (St. Jude Medical) is the first device specifically designed for percutaneous closure of paravalvular leak with promising results. We present the three-dimensional transesophageal echocardiographic images of a successful outcome of percutaneous closure of a residual mitral paravalvular leak with an Amplatzer® Vascular Plug III device (St. Jude Medical), after an initial procedure of percutaneous closure with an Amplatzer® duct occluder (St. Jude Medical).

Transcatheter closure of paravalvular leaks: short- and medium-term outcomes / Cierre transcatéter de fugas paravalvulares: resultados a corto y mediano plazo

Abstract Background: Paravalvular leak (PVL) is a frequent and important complication after surgical valvular replacement that can cause heart failure and hemolytic anemia and is associated with poor clinical outcomes. Surgical reoperation has been the standard treatment, but it is associated with high morbidity and mortality. Transcatheter closure is a therapeutic alternative. The aim of the present study is to analyze the feasibility and the short- and medium-term outcomes of the transcatheter closure of PVLs. Methods: Single-center registry of consecutive patients with post-surgical PVLs that underwent transcatheter closure, between January 2006 and December 2016. Efficacy and safety results were analyzed during the procedure and at 6-month follow-up. Results: Twenty-one PVLs (15 mitral, 5 aortic, and 1 tricuspid) were closure during 20 procedures. In the initial echocardiography, 91% of the leaks were severe. The most used device was the Amplatzer Vascular Plug III® in 10 procedures (50%). The three-dimensional transesophageal echocardiography was used in 70% of cases. The device was successfully implanted in 95% of cases, a regurgitation reduction ≥ 1 grade was achieved in 95% of the cases, and the clinical success was 79%. Six-month survival was 100%; however, three cases required valvular surgery (15%). Conclusions: Transcatheter closure of PVLs is a feasible and safe procedure with high rates of technical, echocardiographic, and clinical success in the short and medium term. It is an adequate therapeutic alternative, mainly in high surgical risk patients and multiples comorbidities.

Resumen Introducción: La fuga paravalvular es una complicación frecuente e importante posterior al reemplazo valvular quirúrgico que puede ocasionar insuficiencia cardiaca, anemia hemolítica y se relaciona con malos resultados clínicos. La reintervención quirúrgica ha sido el tratamiento habitual, pero se acompaña de alta morbimortalidad. El cierre transcatéter es una alternativa terapéutica. El objetivo del presente estudio es analizar la factibilidad y los resultados a corto y mediano plazo del cierre transcatéter de fugas paravalvulares con dispositivos oclusores. Métodos: Registro unicéntrico de una serie consecutiva de pacientes con fugas paravalvulares posquirúrgicas que fueron cerradas vía transcatéter con dispositivos oclusores, entre enero del 2006 y diciembre del 2016. Se analizaron los resultados de eficacia y seguridad durante el procedimiento y a seis meses. Resultados: Se trataron 21 fugas paravalvulares (15 mitrales, 5 aórticas y 1 tricuspídea) durante 20 procedimientos. El 91% de las fugas fue grave en la ecocardiografía inicial. El dispositivo utilizado con más frecuencia fue el Amplatzer Vascular Plug III® en 10 procedimientos (50%). Se utilizó ecocardiografía transesofágica tridimensional en 70% de los casos. Se logró implantar el dispositivo con éxito en el 95% de los casos; se consiguió una reducción ≥ 1 del grado de regurgitación en el 95% de las veces y se alcanzó el éxito clínico en el 79%. A seis meses la supervivencia fue del 100%; sin embargo, tres casos requirieron cirugía valvular (15%). Conclusiones: El cierre transcatéter de fugas paravalvulares es un procedimiento factible, seguro y con tasas elevadas de éxito técnico, ecocardiográfico y clínico a corto y mediano plazo. Es una alternativa terapéutica adecuada, en particular en pacientes considerados de alto riesgo quirúrgico y múltiples comorbilidades.

[Usefulness of intracardiac echocardiography in interventional catheterization in congenital cardiopathies]. / Utilidad de la ecocardiografía intracardíaca en el cateterismo intervencionista de las cardiopatías congénitas.

Intracardiac echocardiography is a new ultrasound image method that we are using during interventional cardiac procedures. Our experience began in June 2002 and until August 2003 we have treated 52 patients with atrial septal defect using this method as control tool for the procedure. This diagnostic method avoids the need for general anesthesia, achieves better views of the left heart structures, stretching balloon and device, and avoids the pharyngeal pain associated with the use of transesophageal probes. The disadvantages are the need to use 10 F introducers in small children, it still does not have the possibility of 3-Dimensional reconstruction and the cost of the catheter.

[Septal defects treatment with Amplatzer occluders]. / Tratamiento con oclusores Amplatzer de los defectos septales.

Since February 1999, we started the program to treat cardiac defects with Amplatzer occluders. We have treated 118 patients with atrial septal defect, 182 patients with patent ductus arterious, 11 with hypertensive arterial duct treated with the ventricular septal occluder, and 7 patients with ventricular septal defect. In this communication we detail our results with these devices.

[Repair of interatrial septal defect with an Amplatzer device. Experience with 3 cases]. / Cierre de comunicación interatrial con dispositivo de Amplatzer. Experiencia de 3 casos.

We performed transcatheter closure of an atrial septal defect (ASD) using an Amplatzer device in three patients, 2 women and 1 male child, aged 12, 54, and 4 years, respectively, coursing with ostium secundum ASD. Two with left to right shunt and the third with bidirectional shunt. The transesophageal echocardiogram revealed ASD with diameters of 13, 15, and 10 mm, the diameter with expanded catheter balloon was of 30, 26, and 17 mm, respectively. The superior border of the atrial septum was bigger than 5 mm in all three patients, whereas the inferior border could not be found through echocardiography in the patients aged 12 and 4 years. Amplatzer devices of 30, 26, and 17 mm were implanted, the inferior border of the first two could be supported on the aortic wall and the superior border on the septum. We observed a 100% occlusion in these two cases through ecocolor-Doppler. In the third patient, an inferior border of 16 mm and a superior border of 8 mm were determined, achieving and immediate and fast installation of the device with 100% occlusion. All three patients were in stable conditions, asymptomatic and without shunt at their one-month follow-up as revealed by a trans-thoracic echocardiography. It is concluded that the Amplatzer device is technically easy to install and yields adequate results even in patients with ample ASD and without inferior border of the inter-atrial septum.

Balloon angioplasty in aortic coarctation: a multicentric study in Mexico.

OBJECTIVES: To analyze immediate and long-term results of balloon dilation for aortic coarctation in a three-center experience in Mexico, and to determine factors associated with increased risk. BACKGROUND: Results demonstrated that the procedure is effective and safe, however its use in some groups is still controversial, specially in neonates and infants. METHODS: In a ten-year period, 333 patients with aortic coarctation on underwent balloon dilation with an immediate success rate of 93.7% and a major complication incidence of 1.8%. Of the total cohort, 272 patients were followed for a period of 24.3 +/- 20 months. Demographic and procedural data were analyzed to determine factors related to a poor outcome or to sustained high blood pressure. RESULTS: Cox regression analysis found age (risk ratio 3.42 p = 0.0001), isthmic hypoplasia (risk ratio 4.64, p < 0.0001), and post-dilation gradient (risk ratio 2.19, p = 0.0113) as independent risk factors for a follow-up event, mainly restenosis. Age at dilation was the only independent factor related to sustained hypertension with a seven-fold increase in the risk. CONCLUSIONS: Balloon dilation is an effective and safe alternative to treat aortic coarctation. Patients younger than one year of age, with severe isthmic hypoplasia and a post-dilation gradient > 20 mmHg have the highest risk to develop an event in the follow-up period. When the dilation procedure is performed in patients older than 10 years of age, and specially those older than 20 years, the probability that they remain or develop high blood pressure is increase.

[Percutaneous closure of atrial septal defects with the Amplatzer® device: 15 years of experience]. / Cierre percutáneo de la comunicación interauricular con el dispositivo Amplatzer(®): 15 años de experiencia.

INTRODUCTION: Percutaneous closure of atrial septal defects is an alternative to surgical treatment. OBJECTIVES: We report the results of percutaneous closure of atrial septal defects with the Amplatzer(®) device. METHOD: We include patients taken to the catheterization laboratory from September 1997 to December 2011. RESULTS: We proceeded with defect closure in 721 patients and in 85 the defect was considered not suitable for closure. The stretched diameter of the defect was 23±6.7mm (limits, 5-42). All devices were positioned successfully. In 15 cases (2.1%) the device was changed due to instability and in 6 (0.8%) the device embolized within the first 24h, 4 were retrieved and repositioned (final success with intention to treat 719/806-89.2%). Immediate control showed complete closure in 247 patients (34.3%), leak through the device in 395 (54.9%), mild residual leak in 75 (10.4%) and moderate in 2 (0.3%). We have follow-up in 626 patients (87.1%) for 33±27.5 months, with headache in 54 (8.6%), new supraventricular arrhythmia in 10 (1.6%), puncture site complications in 4 (0.6%), and stroke in one (0.1%). CONCLUSION: The design of the Amplatzer(®) device allows effective closure of atrial septal defects with a simple technique and patient safety.