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INTRODUCTION: With the development of transcatheter interventional techniques and the introduction of next-generation duct occluder devices, transcatheter closure has become the first treatment option for patent ductus arteriosus (PDA) in pediatric patients. In this study, we compared the effectiveness and safety of different devices for transcatheter PDA closure in pediatric patients, focusing on long-term outcomes. METHODS: A total of 235 patients aged 0-18 years who underwent transcatheter PDA closure at a tertiary care center between January 2005 and February 2020 were included. The medical records of the cases were retrospectively evaluated. RESULTS: The median age of the patients was 2.3 years (range: 3.5 months to 17 years), with a mean weight of 12.8 kg (range: 5.7-43.2 kg). The mean PDA diameter at its narrowest point was 2.9 mm (range: 2.2-5.1 mm). Ductal anatomy was as follows: Type A in 98 (41.7%) patients, Type E in 36 (15.6%) patients, Type C in 32 (13.5%) patients, Type F in 27 (11.4%) patients, Type D in 23 (9.7%) patients, and Type B in 19 (8.1%) patients. Arterial access was used in 138 (57.1%) patients, venous + arterial access in 58 (24.6%) patients, and venous access only in 39 (16.5%) patients. Closure was performed with Amplatzer Duct Occluder (ADO; AGA Medical Corp., Golden Valley, MN, USA) II in 151 (64.2%) cases, ADO I in 43 (18.2%) cases, and coils in 41 (17.4%) cases. The mean fluoroscopy time and mean procedural time were 10.3 ± 4.2 minutes and 41 ± 7.2 minutes, respectively. The mean radiation dose was 1364 ± 497 cGy/min. The early closure rate after the procedure was 92%, while residual shunting on the first day post-procedure was observed in 1.8% of cases, decreasing to 0.1% at the one-month follow-up. The overall procedural success rate for all cases was 96.0%. The mean follow-up duration was 9.7 years (range: 2.9-13.8 years). CONCLUSION: For percutaneous PDA closure, ADO I devices are preferred for larger defects, whereas ADO II devices are prioritized for small- to medium-sized defects instead of coils.

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An 89-year-old woman was referred for closure of a patent ductus arteriosus (PDA). Contrast-computed tomography showed Krichenko type C PDA with severe calcification (Figure 1). Initial angiography revealed severe calcification of the PDA (Figure 2, Video 1), and the mid-ductus diameter was 6 mm and the ductus length was 14 mm..

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Background: Transcatheter closure of perimembranous ventricular septal defect (VSD) is a promising alternative to surgical closure but has been associated with conduction disorders. Vascular access via multiple large vessels is associated with procedure-related complications, undermining the benefit of percutaneous approaches. In this case, we present the first-in-man transcatheter closure of a perimembranous VSD with an Amplatzer Duct Occluder IΙ in an adult patient via a single transradial artery access. Case summary: A 62-year-old female was admitted to the hospital due to gradually worsening fatigue and shortness of breath on exertion. Transoesophageal echocardiogram (TOE) revealed a VSD size of 4-6 mm and a left ventricular ampulla size of 12 mm. A percutaneous VSD closure with the Amplatzer Duct Occluder II was decided. The angiography and TOE showed successful device placement and excellent procedural results. The patient was discharged home the next day after the procedure. The patient did not report any post-procedural complications during the 8-month follow-up. Echocardiographic assessment showed a gradual decrease in left ventricular dimensions. Discussion: Transcatheter closure of perimembranous VSD is a promising alternative to surgical closure, but it is not free of complications. Traditional VSD occluders rely on multivessel access and complex formation of arteriovenous loops. In this case, we report the feasibility of perimembranous VSD closure with an Amplatzer Duct Occluder IΙ via a single radial artery access in an adult patient. This approach is a much simpler technique with several potential advantages and should be considered in selected adult patients and in similar clinical scenarios.

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Backgrounds: The traditional treatment of doubly committed subarterial ventricular septal defect (dcVSD) is open-heart surgery. This study aimed to evaluate the feasibility, safety, and outcome of transcatheter closure of small dcVSD using Amplatzer duct occluder-II (ADO-II) in children. Methods: Between January 2016 and April 2021, 24 children (17 male and 7 female patients) with small dcVSD who received transfemoral closure with ADO-II were enrolled retrospectively. All of their available clinical and follow-up data were evaluated. Results: The patients' median age was 3.2 years (1.6-12.6 years, 4.2 ± 3.1 years) and body weight was 13.3 kg (10.0-38.5 kg, 16.5 ± 7.7 kg). Left ventricular angiography showed that the median dcVSD size was 2.0 mm (1.5-3.5 mm, 2.1 ± 0.6 mm). The device was successfully implanted in 23 patients (95.8%), and one patient failed to be closed because of the underestimation of defect size due to preoperative aortic valve prolapse, with 16 patients by the antegrade approach and eight patients by retrograde approach. The diameters of the device used were 3/4, 4/4, and 5/4 mm. The median operative time was 40.0 min (20.0-75.0 min, 41.7 ± 13.7 min), and the median fluoroscopic time was 5.0 min (3.0-25.0 min, 6.8 ± 5.0 min). With a follow-up duration of 1+ to 45+ months, only 1 patient presented with new-onset mild aortic regurgitation (AR). Conclusion: Transfemoral closure of small dcVSD with ADO-II is technically feasible and safe in the selected children. However, the development or worsening of AR requires long-term follow-up.

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Perimembranous ventricular septal defect (pmVSD) is a common congenital heart disease that is sometimes associated with indirect left ventricle (LV) to right atrium (RA) shunt (indirect Gerbode defect). This defect has a rare chance of spontaneous closure and therefore was usually closed surgically in the past, but more recently transcatheter closure has been reported by a few authors. In our study, we have described a series of 14 children (age ranging from 1.2 to 12 years and weight ranging from 7.2 to 25.5 kg) with the above-mentioned defect which were closed by various interventional devices. The procedures were successful in complete elimination of pmVSD and immediate reduction of indirect LV-RA shunts with negligible residual tricuspid regurgitation on follow-up. In our midterm experience, the judicious use of double-disc devices is efficacious for occluding pmVSD associated with indirect Gerbode defect.

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Objective: The aim of this study was to assess the efficacy and safety of transcatheter retrograde closure of perimembranous ventricular septal defect (pmVSD) via the femoral artery with an Amplatzer Duct Occluder II (ADO II) in children. Methods: The clinical and follow-up data of 102 children who had successfully undergone transcatheter retrograde closure of pmVSD via the femoral artery with Amplatzer Duct Occluder II (ADO II) from February 2012 to June 2019 in our center were retrospectively reviewed. Results: In 102 of 103 patients, the defects were successfully closed (99.0%). The average age was 4.03 ± 1.84 years and the mean weight was 17.50 ± 5.58 kg. The mean diameter of the defects was 2.58 ± 0.63 mm. Hundred of the occluders had a waist length of 4 mm. The complete closure rate was 89.2% 24 h after the procedure and 98% at the last follow-up. The follow-up period ranged from 6 to 92 months, with a median of 36 months. One child developed new mild aortic regurgitation (AR), and 9 patients developed new mild tricuspid regurgitation (TR). During follow-up, TR disappeared in 5 patients and decreased in 4 patients, and AR relieved in one patient. One patient developed intermittent complete left bundle branch block 4 days after the procedure and recovered sinus rhythm 2 days later. No serious complications occurred. Conclusion: Transcatheter retrograde closure of pmVSD via the femoral artery with ADO II in children is safe, feasible, and effective in selected patients.

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We report the case of a 22-year-old female patient with complex congenital heart disease and multiple cardiac surgeries who came to our attention for right heart failure and hemolysis 3 years after aortic valve replacement surgery. She was diagnosed with aorta-to-right ventricle fistula and was efficiently treated with retrograde implantation of an Amplatzer Duct Occluder II device using three-dimensional multimodality fusion imaging.

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BACKGROUND/PURPOSE: Outlet-type VSD is frequently associated with aortic valve prolapse that surgery is frequently required. The literature regarding outcomes of transcatheter closure of outlet-type VSDs is scant. This study was conducted to know the safety and efficacy of transcatheter closure of outlet-type ventricular septal defects (VSDs) with Amplatzer Duct Occluder II (ADO II). METHODS: Medical records of patients underwent attempted transcatheter closure of outlet-type VSD with ADO II between October 2013 and August 2019 were retrospectively reviewed. RESULTS: Among 49 patients, transcatheter closure was successful in 45 (91.8%; 33 males and 12 females; mean [± standard deviation] age and body weight: 15.8 (±17.7) years and 36.6 (±23.3) kg, respectively). The median VSD diameter was 4.0 mm (range: 1.2-6.0 mm). Device closure failed in four because the sheath could not be advanced through a prograde or retrograde route in one patient, occluder embolization in the two patients, and failed right ventricular disc anchoring in one patient. After a mean follow-up of 22.7 months (range: 0.3-51.1 months), only nine (20.0%) patients had increased severity in aortic regurgitation (AR) on the echocardiography. Preprocedural AR decreased in severity or even disappeared in 11 (24.4%) patients. No heart block or device failure occurred during follow-up. A trivial-to-small residual shunt was detected in 19 patients (42.2%) in the most recent echocardiography. CONCLUSION: Transcatheter closure of outlet-type VSDs with ADO II is feasible. Although no significant aggravation of AR was observed in the short-to-mid-term follow-up, long-term follow-up is mandatory.

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BACKGROUND: Dyspnoea is very common in elderly patients and can be caused by a variety of different diseases. However, the initial diagnosis of patent ductus arteriosus (PDA) as a cause of left heart failure is very rare in this patient population. CASE SUMMARY: A 69-year-old physically active woman with known hypertension presented with worsening exertional dyspnoea. Echocardiography showed a dilated left ventricle with moderately reduced left ventricular ejection fraction, and evidence for PDA. The PDA was confirmed by computed tomography angiography and successfully closed by implantation of an Amplatzer PDA occluder II 06-06 mm. As a result, the heart failure symptoms receded completely. DISCUSSION: Congenital heart diseases should be considered as heart failure causes even in older adults. In addition to the standard medical therapy, there may be effective interventional treatment options to reverse the symptoms of heart failure in such patients.

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A 6-month-old infant with moderate-sized patent ductus arteriosus (PDA) and inadequate weight gain underwent closure of the duct using Amplatzer Ductal Occluder II (ADO II). She developed severe progressive left pulmonary artery (LPA) stenosis due to protrusion of the disc at the pulmonary end of the ADO II. She was subjected to balloon angioplasty of the LPA stenosis with suboptimal result. Hence, she was subjected to stenting of the LPA using a Formula stent which could be subsequently postdilated to keep up with the growth of the child. Immediate and short-term results were excellent anatomically as well as physiologically.

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AIM: The purpose of this study is to describe the special aspects of perimembranous ventricular septal defects (pmVSD) closure by utilizing Amplatzer Duct Occluder II (ADO II) devices with a rational request for bigger ADO-II sizes, based on our experience in transcatheter device closure of pmVSD. METHODS AND RESULTS: At our institution, placement of an ADO II device was used in 15 patients with pmVSD; the patients' age ranged between 6 months and 20 years. The indications for closure were CHF (n = 4), hemodynamically significant shunt (n = 7), tricuspid regurgitation (n = 3), and high risk for infective endocarditis (n = 2), respectively. The location of the VSD was infracristal in 13 patients, supracristal in 1, and a postsurgical Gerbode VSD in another one. Implantation of the device was successfully performed without embolization, any evidence of an AV block, or other conductance abnormalities during implantation and follow-up in the mean of 2.5 years (range 2 months-6.5 years). CONCLUSIONS: Transcatheter closure of a pmVSD with ADO II is feasible in all pediatric and young adult age groups, by considering the device diameter limitations. The off-label use of ADO II implantation seems to be safe for VSDs closure up to 6 mm of size and feasible for various locations including unusual morphology such as postsurgical Gerbode defect.

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Sinus of Valsalva (SV) rupture is a rare, cardiac complication after surgical repair of complex congenital heart disease. This paper reports a 4-year-old male child with double outlet right ventricle (RV) and pulmonary stenosis with superior-inferior arrangement of the ventricles, who was submitted to surgical repair using the "reparation a l'etage ventriculaire" procedure. A few months after an uneventful surgical repair, his clinical condition abruptly worsened because of the rupture of the right SV into the RV outflow tract resulting in large left-to-right shunt and RV functional impairment. To avoid surgical re-do, this late-onset complication was successfully treated by transcatheter implantation of an Amplatzer Duct Occluder Type II Additional Size™ (ADO-IIAS, St. Jude Medical Inc., St. Paul, Minnesota, USA) device.

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AIMS: In this study, we examined the differences in cost and effectiveness of various devices used for the closure of small to medium sized patent ductus arteriosus (PDA). SETTING AND DESIGN: We retrospectively studied 116 patients who underwent closure of small PDAs between January 2010 and January 2015. SUBJECTS AND METHODS: Three types of devices were used: the Amplatzer duct occluder (ADO) II, the cook detachable coil and the Nit Occlud coil (NOC). Immediate and late complications were recorded and patients were followed up for 3 months after the procedure. STATISTICAL METHODS: All statistical calculations were performed using Statistical Package for the Social Science software. P <0.05 were considered significant. RESULTS: We successfully deployed ADO II devices in 33 out of 35 cases, cook detachable coils in 36 out of 40 cases and NOCs in 38 out of 41 cases. In the remaining nine cases, the first device was unsuitable or embolized and required retrieval and replacement with another device. Eleven patients (9.5%) developed vascular complications and required anticoagulation therapy. Patients who had hemolysis or vascular complications remained longer in the intensive care unit, with consequently higher total cost (P = 0.016). Also, the need for a second device increased the cost per patient. CONCLUSIONS: The cook detachable coil is the most cost-effective device for closure of small-to medium-sized PDAs. Calculations of the incremental cost-effectiveness. (ICE) revealed that the Cook detachable coil had less ICE than the ADO II and NOC. The NOC was more effective with fewer complications.

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INTRODUCTION: Off-label use of different devices has been described for percutaneous closure of ventricular septal defects (VSD) because of the unacceptable rate of post-procedure heart block associated with special VSD devices. AIM: To describe the early single-center clinical experience with closure of a VSD using the Amplatzer Duct Occluder II (ADO II) device in children. MATERIAL AND METHODS: Between May 2013 and June 2015, 26 patients between 13 days and 16 years of age underwent percutaneous closure of a VSD with an ADO II device at our institute. The decision to use the ADO II device was based primarily on lower risk of total atrioventricular block (TAVB) after VSD closure reported in the literature, reduction of the cost of the procedure and the need to close symptomatic VSDs in young patients. RESULTS: The location of the VSD was perimembranous in 21 patients, postsurgical residual in 2, midmuscular in 2 and apical muscular in 1. Complex procedures including newborn, combined procedures and postsurgical residual VSD were performed in 5 (19%) patients. The median duration of follow-up was 12 months. The complete VSD closure rate was 81% immediately after the procedure, 85% at 24 h, and 93% at the last follow-up. There was no device embolization. During the entire follow-up period, TAVB did not develop. CONCLUSIONS: The ADO II constitutes a safe and effective therapeutic alternative for morphologically varied VSDs in all pediatric age groups. A larger range of sizes and configurations of this occluder may be required to successfully occlude a wider range of VSDs.

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OBJECTIVES: This study reports a novel transcatheter procedure for residual mitral regurgitation (MR) after MitraClip implantation using the Amplatzer Duct Occluder II (ADO II). BACKGROUND: Although the MitraClip procedure is a transcatheter treatment option for patients at high surgical risk with severe MR, management of significant residual MR after MitraClip implantation is still challenging. METHODS: We describe a case series of 9 consecutive patients who underwent transcatheter deployment of the ADO II plug for significant residual MR after MitraClip implantation from April to October 2015. RESULTS: The mean age was 79.3 ± 11.4 years. The deployment of the ADO II plug was performed at the initial MitraClip procedure in 7 patients and at the second procedure for recurrent symptoms in 2 patients. There were 2 types of residual MR seen after MitraClip implantation: residual commissural MR (n = 3) and residual intraclip MR (n = 6). The ADO II was successfully deployed with significant reduction of MR flow and left atrial pressure in all patients. The ADO II plug was retrieved in 1 patient because of device embolization to the ostial right coronary artery. However, all patients were discharged 1.8 ± 1.2 days after the procedure, with no significant MR on pre-discharge transthoracic echocardiography. In 8 patients who underwent 1-month symptomatic assessment, clinical symptoms were diminished to New York Heart Association functional class I or II. CONCLUSIONS: Transcatheter deployment of the ADO II plug was effective for the reduction of residual commissural MR and intraclip MR after MitraClip implantation. The potential role of this technique should be established for challenging cases.

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Introducción: En las últimas décadas, varios dispositivos se han utilizado para el cierre percutáneo del conducto arterioso permeable con sus propias limitaciones y riesgos. El Amplatzer Duct Occluder II ha sido diseñado para mejorar dichas limitaciones y reducir complicaciones. Objetivo: Presentar una serie inicial de pacientes llevados a cierre percutáneo del conducto arterioso con el Amplatzer Duct Occluder II, enfatizando en los aspectos técnicos del procedimiento. Métodos: Analizamos los registros clínicos de 9 pacientes con conducto arterioso permeable, llevados a cierre percutáneo con el Amplatzer Duct Occluder II. La mediana de edad fue de 24 meses (8-51 meses) y del peso de 10.7 kg (6-16.3 kg). El diámetro mínimo del conducto arterioso permeable fue de 2.7 mm (1-5 mm). Resultados: El implante fue exitoso en todos los casos. Los dispositivos más utilizados (33.3%) fueron los de dimensiones 4-4 mm (3 pacientes), en 2 pacientes se utilizó de 3-4 mm y en el resto de los pacientes se emplearon oclusores de otros tamaños. Cuatro casos mostraron flujo residual leve inmediatamente después del cierre. El cierre total a las 24 h se logró en 8 de 9 niños (89%). No hubo embolización del dispositivo o mortalidad con el procedimiento y solo observamos una complicación menor. Conclusión: El Amplatzer Duct Occluder II en esta serie de casos fue efectivo en el 89% de los pacientes a las 24 h y en el 100% al seguimiento. Su implante fue seguro debido a que no hubo complicaciones mayores. La tasa de oclusión es comparable a la informada para el Amplatzer Duct Occluder I.

Introduction: In the last decades, several devices have been used for the percutaneous closure of patent ductus arteriosus, with its own limitations and risks. The Amplatzer Duct Occluder II has been designed to overcome those limitations and reduce risks. Objective: We described our initial series of patients who underwent percutaneous closure of patent ductus arteriosus with the Amplatzer Duct Occluder II, emphasis on the technical aspects of the procedure. Methods: We reviewed the clinical records of 9 patients with patent ductus arteriosus who underwent percutaneous closure with the Amplatzer Duct Occluder II. Median age was 24 months (range 8-51 months) and the median weight was 10.7 kg (range 6-16.3 kg). The minimal ductus arteriosus diameter was 2.7 mm (1-5 mm). Results: Implantation was successful in all cases. The devices most commonly used (33.3%) were the dimensions 4-4 mm (3 patients), in 2 patients were used 3-4 mm and in the rest of the patients were employed occluder other sizes. Four cases showed slight residual flow immediately after implantation. Total closure was achieved in 24 h in 8 of 9 patients (89%). There was no embolization of the occluder or deaths during the procedure and we only observed one minor complication. Conclusions: The Amplatzer Duct Occluder II in this series was effective in 89% of the patients at 24 hs after the procedure and 100% follow-up. The implantation was safe and no major complications were observed. The occlusion rate is comparable to those reported for the Amplatzer Duct Occluder I.

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INTRODUCTION: In the last decades, several devices have been used for the percutaneous closure of patent ductus arteriosus, with its own limitations and risks. The Amplatzer Duct Occluder II has been designed to overcome those limitations and reduce risks. OBJECTIVE: We described our initial series of patients who underwent percutaneous closure of patent ductus arteriosus with the Amplatzer Duct Occluder II, emphasis on the technical aspects of the procedure. METHODS: We reviewed the clinical records of 9 patients with patent ductus arteriosus who underwent percutaneous closure with the Amplatzer Duct Occluder II. Median age was 24 months (range 8-51 months) and the median weight was 10.7kg (range 6-16.3kg). The minimal ductus arteriosus diameter was 2.7mm (1-5mm). RESULTS: Implantation was successful in all cases. The devices most commonly used (33.3%) were the dimensions 4-4mm (3 patients), in 2 patients were used 3-4mm and in the rest of the patients were employed occluder other sizes. Four cases showed slight residual flow immediately after implantation. Total closure was achieved in 24h in 8 of 9 patients (89%). There was no embolization of the occluder or deaths during the procedure and we only observed one minor complication. CONCLUSIONS: The Amplatzer Duct Occluder II in this series was effective in 89% of the patients at 24hs after the procedure and 100% follow-up. The implantation was safe and no major complications were observed. The occlusion rate is comparable to those reported for the Amplatzer Duct Occluder I.

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