Transcatheter Occluder Devices for the Closure of Atrial Septal Defect in Children: How Safe and Effective Are They? A Systematic Review.

Atrial septal defect (ASD) is a hole in the interatrial septum (IAS) of the heart that is one of the most common congenital heart diseases (CHD). Percutaneous transcatheter device occlusion is one of the techniques that have been developed for the closure of atrial septal defects. The primary objective of this study is to assess the safety and efficacy of septal occluder devices in the management of atrial septal defect in children. We searched PubMed, Science Direct, and Google Scholar databases to collect relevant articles according to a predetermined eligibility criteria and included 21 papers of different study designs in this systematic review. We found that transcatheter closure is safe and effective in most children with ASD. The major complications reported could be avoided by comprehensive clinical assessment and echocardiographic evaluation to determine appropriate device size and implantation strategy per individual child. Further research involving more clinical trials with larger sample size and longer duration of followup is required to improve the safety of existing devices for their use in all children with ASD despite their weight and defect size, and also the efficacy of newer devices such as biodegradable septal occluders.

Late Bacterial Endocarditis in an Intravenous Drug User With an Amplatzer Septal Occluder.

Infective endocarditis of a fully endothelialized cardiac prosthesis, and especially the late presentation of endocarditis, challenges our current understanding of device-related complications. Late bacterial endocarditis associated with the Amplatzer Septal Occluder, a device frequently used to close atrial septal defects, has been documented only rarely. We report the case of an intravenous drug user who had late infective endocarditis associated with his Amplatzer Septal Occluder, secondary to methicillin-sensitive Staphylococcus aureus bacteremia nearly 14 years after device insertion. The patient recovered after surgical excision and débridement of the vegetative mass, which may be the first time that a surgical approach has been taken to treat this condition. This report corroborates the need for late screening of high-risk patients who have septal occluder devices.

First results of the Brazilian Registry of Percutaneous Left Atrial Appendage Closure / Primeiros Resultados do Registro Brasileiro de Oclusão Percutânea do Apêndice Atrial Esquerdo

Abstract Background: Left atrial appendage closure (LAAC) is an effective alternative to oral anticoagulation (OA) for the prevention of stroke in patients with non-valvular atrial fibrillation (NVAF). Objective: To present the immediate results and late outcomes of patients submitted to LAAC and included in the Brazilian Registry of Percutaneous Left Atrial Appendage Closure. Methods: 91 patients with NVAF, high stroke risk (CHA2DS2VASc score = 4.5 ± 1.5) and restrictions to OAC (HAS-BLED score = 3.6 ± 1.0) underwent 92 LAAC procedures using either the Amplatzer cardiac plug or the Watchman device in 11 centers in Brazil, between late 2010 and mid 2016. Results: Ninety-six devices were used (1.04 device/procedure, including an additional non-dedicated device), with a procedural success rate of 97.8%. Associated procedures were performed in 8.7% of the patients. Complete LAAC was obtained in 93.3% of the successful cases. In cases of incomplete closure, no residual leak was larger than 2.5 mm. One patient needed simultaneous implantation of 2 devices. There were 7 periprocedural major (5 pericardial effusions requiring pericardiocentesis, 1 non-dedicated device embolization and 1 coronary air embolism without sequelae) and 4 minor complications. After 128.6 patient-years of follow-up there were 3 deaths unrelated to the procedure, 2 major bleedings (one of them in a patient with an unsuccessful LAAC), thrombus formation over the device in 2 cases (both resolved after resuming OAC for 3 months) and 2 strokes (2.2%). Conclusions: In this multicenter, real world registry, that included patients with NVAF and high thromboembolic and bleeding risks, LAAC effectively prevented stroke and bleeding when compared to the expected rates based on CHA2DS2VASc and HASBLED scores for this population. Complications rate of the procedure was acceptable considering the beginning of the learning curve of most of the involved operators.

Resumo Fundamento: A oclusão percutânea do apêndice atrial esquerdo (OAAE) é uma alternativa eficaz à anticoagulação oral (ACO) para a prevenção de acidente vascular cerebral (AVC) em pacientes com fibrilação atrial não-valvular (FANV). Objetivo: Apresentar os resultados imediatos e o seguimento tardio de pacientes submetidos a OAAE e incluídos no Registro Brasileiro de Oclusão Percutânea do Apêndice Atrial Esquerdo. Métodos: 91 pacientes com FANV, alto risco de AVC (escore CHA2DS2VASc = 4,5 ± 1,5) e restrição à AO (escore HAS-BLED = 3,6 ± 1,0) foram submetidos a 92 procedimentos de OAAE com as próteses Amplatzer Cardiac Plug e Watchman em 11 centros do Brasil, entre o final de 2010 e a metade de 2016. Resultados: Utilizaram-se 96 próteses no total (1,04 próteses/procedimento, incluindo-se o uso de 1 prótese não-dedicada adicional em um dos casos), obtendo-se sucesso em 97,8% dos procedimentos. Realizaram-se procedimentos associados à OAAE em 8,7% dos pacientes. Observou-se oclusão total do AAE em 93,3% dos casos com sucesso, e nos casos de oclusão incompleta, nenhum leak foi > 2,5 mm. Um paciente necessitou do implante simultâneo de 2 próteses. Houve 7 complicações maiores periprocedimento (5 derrames pericárdicos necessitando pericardiocentese, 1 embolização da prótese não-dedicada e 1 embolia aérea coronariana sem sequelas) e 4 menores. No seguimento de 128,6 pacientes-ano, houve 3 óbitos não relacionados ao procedimento, 2 sangramentos maiores (um deles em um dos casos de insucesso da OAAE), formação de trombo sobre a prótese em 2 casos (tratados com sucesso com reinstituição da ACO por 3 meses), e 2 AVCs (2,2%). Conclusões: Neste registro multicêntrico de mundo real, que incluiu pacientes com FANV e alto risco de sangramento e de eventos tromboembólicos, a OAAE foi eficaz na prevenção de AVC e sangramento quando comparada às taxas de AVC previstas pelos escores CHA2DS2VASc e HASBLED para esta população. O índice de complicações do procedimento foi aceitável, considerando se tratar do início da curva de aprendizado da maioria dos operadores envolvidos.

Unconventional uses of septal occluder devices: Our experience reviewed.

UNLABELLED: Device closure is now an accepted modality of treatment for cardiac septal defects such as fossa ovalis Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) and Patent Ductus Arteriosus (PDA) and have well-accepted indication and long term results. Devices used for these defects have been specifically designed for use in closing these defects. In this manuscript, we are reporting the efficacy of closure of nonseptal defects with devices conventionally used for septal cardiac defects although they have not been prototyped for use in such conditions. AIM: To study use of occluder devices in nonseptal defects/malformation. MATERIAL & METHODS: 39 patients, in the age group 2-67 yrs, were treated percutaneously with occluder devices for various conditions. These included: coronary arteriovenous (CAV) fistula (n = 6), pulmonary AV fistula (n = 4), systemic AV fistula (vascular plug; n = 1), closure of AP window (duct occluder; n = 3), closure of ascending aorta perforation (septal occluder; n = 2), ruptured sinus of Valsalva (RSOV) (duct occluder; n = 13), Fontan fenestration closure (ASD septal occluder, patent foramen ovale device, vascular plug n = 3,1 each), splenic artery (duct occluder; n = 1), Balock Taussig shunt (duct occlude; n = 1)and closure of mitral paravalvular leak (n = 3; duct occlude devices = 2, VSD device: n = 1) and aortic paravalvular leak n = 2 (duct occluder; n = 2 additional vascular plug = 2). RESULTS: Procedural success: Successful closure as signified by no residual shunt was achieved in all coronary AV fistula (immediately n = 2, at 3 months in all), ruptured sinus of Valsalva (immediate in all), fenestrated Fontan (immediately in all), and ascending aorta perforations (immediate), mitral paravalvular leak (immediate in none, and late in 2/3). The aortic paravalvular leak closed at 3 months follow-up in one and small residual persisted after 1 month in another. COMPLICATIONS: Local site Hematoma was observed in 4 patients. 2 of them required post procedure transfusion for the same. Hematuria was observed in 2 of the 4 patients of mitral paravalvular leak and 2 patients of RSOV device closure. Hematuria subsided with conservative management before discharge from hospital in all the 4 cases. One patient with residual mitral regurgitation required surgical management for continuing hematuria, anemia and hyperbilirubenemia. There was one mortality observed on table during the attempted closure of a very large RSOV who presented to us in severe congestive heart failure and shock. On follow up ranging from 2 months to 6 years, all the patients are asymptomatic. There was no late complication related to device in any patient. CONCLUSION: It is feasible in selected nonseptal defects, which traditionally have been subjected to surgical interventions, to treat successfully, non surgically with the use of non prototype occluder devices without significant complications. Conventionally these devices have not been recommended for closure of nonseptal defects but show good early outcome. Adequate sample size with good follow up data is necessary before concluding that it can be safe alternative to surgery on long term.