Case report
Successful percutaneous closure of a residual atrial septal defect due to device failure
Encerramento percutâneo de comunicação interauricular residual por falência de dispositivo
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what about after diagnosis?" 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O que sucede após o diagnóstico?" ] ] "contieneTextoCompleto" => array:1 [ "en" => true ] "contienePdf" => array:1 [ "en" => true ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Serdar Bozyelç, Tayfun Sahin" "autores" => array:2 [ 0 => array:2 [ "nombre" => "Serdar" "apellidos" => "Bozyelç" ] 1 => array:2 [ "nombre" => "Tayfun" "apellidos" => "Sahin" ] ] ] ] ] "idiomaDefecto" => "en" "Traduccion" => array:1 [ "en" => array:9 [ "pii" => "S2174204918302514" "doi" => "10.1016/j.repce.2017.11.018" "estado" => "S300" "subdocumento" => "" "abierto" => array:3 [ "ES" => true "ES2" => true "LATM" => true ] "gratuito" => true "lecturas" => array:1 [ "total" => 0 ] "idiomaDefecto" => "en" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2174204918302514?idApp=UINPBA00004E" ] ] "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0870255117308168?idApp=UINPBA00004E" "url" => "/08702551/0000003700000007/v3_201808080407/S0870255117308168/v3_201808080407/en/main.assets" ] ] "en" => array:19 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Case report</span>" "titulo" => "Successful percutaneous closure of a residual atrial septal defect due to device failure" "tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "475.e1" "paginaFinal" => "475.e3" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "Sílvia Aguiar Rosa, Filipa Ferreira, Lídia de Sousa, António Fiarresga, José Diogo Martins, Ana Galrinho, Ana Agapito, Paula Fazendas, Fátima F. Pinto, Rui Cruz Ferreira" "autores" => array:10 [ 0 => array:4 [ "nombre" => "Sílvia" "apellidos" => "Aguiar Rosa" "email" => array:1 [ 0 => "silviaguiarosa@gmail.com" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "Filipa" "apellidos" => "Ferreira" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] 2 => array:3 [ "nombre" => "Lídia" "apellidos" => "de Sousa" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 3 => array:3 [ "nombre" => "António" "apellidos" => "Fiarresga" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 4 => array:3 [ "nombre" => "José Diogo" "apellidos" => "Martins" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] ] ] 5 => array:3 [ "nombre" => "Ana" "apellidos" => "Galrinho" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 6 => array:3 [ "nombre" => "Ana" "apellidos" => "Agapito" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 7 => array:3 [ "nombre" => "Paula" "apellidos" => "Fazendas" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] 8 => array:3 [ "nombre" => "Fátima F." "apellidos" => "Pinto" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] ] ] 9 => array:3 [ "nombre" => "Rui Cruz" "apellidos" => "Ferreira" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] ] "afiliaciones" => array:3 [ 0 => array:3 [ "entidad" => "Cardiology Department, Santa Marta Hospital, Lisbon, Portugal" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Cardiology Department, Garcia de Orta Hospital, Almada, Portugal" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Paediatric Cardiology Department, Santa Marta Hospital, Lisbon, Portugal" "etiqueta" => "c" "identificador" => "aff0015" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "pt" => array:1 [ "titulo" => "Encerramento percutâneo de comunicação interauricular residual por falência de dispositivo" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1914 "Ancho" => 3333 "Tamanyo" => 539931 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">(A and D) Three- (3D TEE) and two-dimensional transesophageal echocardiography images showing residual shunt through the device (22 mm Ultrasept ASD Occluder<span class="elsevierStyleSup">®</span>); (B and C) delivery sheath through the Ultrasept device in fluoroscopic view and in 3D TEE; (E and F) closure of residual shunt in the 22 mm Ultrasept device with a 20 mm Ultrasept PFO device, with the final result documented in fluoroscopic view and in 3D TEE.</p>" ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Case report</span><p id="par0005" class="elsevierStylePara elsevierViewall">A 39-year-old woman presented for percutaneous closure of an ostium secundum atrial septal defect (ASD) with a balloon-sized diameter of 21 mm, which was performed successfully using a 22 mm Ultrasept ASD Occluder<span class="elsevierStyleSup">®</span> (Cardia, Eagan, MN, USA) with no complications, under fluoroscopic and transesophageal echocardiography (TEE) guidance. The day after the procedure, transthoracic echocardiography (TTE) showed a correctly placed device with no residual shunt. Two years after the procedure, TTE followed by TEE revealed a residual left-to-right shunt through the correctly implanted device. Three-dimensional (3D) TEE enabled more detailed characterization, showing a perforation of the membrane coating 0.09 cm<span class="elsevierStyleSup">2</span> in area on the inferior portion of the device (<a class="elsevierStyleCrossRef" href="#fig0005">Figure 1</a>A and D). Although there were no obvious signs of right ventricular overload, the patient complained of fatigue on minimal exertion and occasional chest discomfort.</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0010" class="elsevierStylePara elsevierViewall">She accordingly underwent a second cardiac catheterization for hemodynamic measurement and possible transcatheter closure of the residual shunt. The procedure was performed under general anesthesia, guided by fluoroscopy and real-time 3D TEE (<a class="elsevierStyleCrossRef" href="#fig0005">Figure 1</a>B, C, E and F). The Qp:Qs obtained by catheterization was 1.7 and therefore we decided to proceed with implantation of a second device. We chose a 20 mm Ultrasept PFO occluder with the expectation that a similar device would conform better to the previously implanted occluder.</p><p id="par0015" class="elsevierStylePara elsevierViewall">The device defect was crossed with a combination of a 6 F right Judkins diagnostic catheter (Boston Scientific, Natick, MA) and a standard 0.35″ ZIPwire™ Hydrophilic Guide Wire (Boston Scientific, Natick, MA) placed in the left superior pulmonary vein. We opted not to perform balloon sizing; otherwise the interventional procedure was performed with the standard ASD closure technique, taking extra care with the 9 F delivery sheath to avoid displacement of the device already in place.</p><p id="par0020" class="elsevierStylePara elsevierViewall">During the procedure, 3D TEE was of crucial importance in guiding the position of guidewires and sheaths, delivery and spatial relations between devices.</p><p id="par0025" class="elsevierStylePara elsevierViewall">The procedure took 60 min with a total radiation time of 14 min and total radiation dose of 865 mGy (8101 cGy.cm<span class="elsevierStyleSup">2</span>).</p><p id="par0030" class="elsevierStylePara elsevierViewall">At the end of the procedure 3D TEE documented correct device placement with complete defect coverage and absence of residual shunt.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Discussion</span><p id="par0035" class="elsevierStylePara elsevierViewall">The Ultrasept ASD device is covered by a polyvinyl alcohol (PVA) membrane. PVA is a bioabsorbable elastomeric polymer with good biocompatibility that is commonly used in medical devices due to its low protein adsorption, absence of toxicity and bioadhesive characteristics. Although the use of this material in ASD closure devices is generally successful, a few cases of PVA membrane perforation and recanalization have been described recently.<a class="elsevierStyleCrossRefs" href="#bib0025"><span class="elsevierStyleSup">1,2</span></a> According to company data only 10 cases have been reported, all of them with ASD occluders and none with PFO closure devices. The mechanism by which the PVA coating degrades is not completely understood, but is likely related to incomplete endothelialization due to delayed or inadequate endothelial response.<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">3</span></a> This phenomenon has been reported in a few patients with other ASD devices, such as the Amplatzer™ family, supporting the hypothesis of an absent or inadequate endothelization response in specific patients, of unknown cause.<a class="elsevierStyleCrossRefs" href="#bib0035"><span class="elsevierStyleSup">3,4</span></a> In our patient, there was no evidence of an early residual shunt, but we cannot speculate on the specific causes that may have given rise to this mid-term residual ASD.</p><p id="par0040" class="elsevierStylePara elsevierViewall">We adopted a percutaneous approach guided by real-time 3D TEE, which offered precise spatial location of the perforation and orientation of sheaths and devices. A 20 mm Ultrasept PFO occluder was chosen because (a) it appeared to be the most easily adjustable for the small but asymmetric hole, (b) no residual holes have been reported in these devices, (c) we thought that it would be better to juxtapose two devices with the same type of frame, and (d) it has a low profile, resulting in a small increase in thickness and no compression of surrounding structures, particularly the aortic wall.</p><p id="par0045" class="elsevierStylePara elsevierViewall">This case highlights the importance of close follow-up in all patients with ASD treated with implanted devices. There should be a low threshold for TEE in the event of any suspicious findings on TTE or changes in the patient's clinical status. Our case demonstrates a new and successful way of correcting ASD device perforations with a percutaneous approach that avoids the need for surgical intervention.</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Ethical disclosures</span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Protection of human and animal subjects</span><p id="par0050" class="elsevierStylePara elsevierViewall">The authors declare that no experiments were performed on humans or animals for this study.</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Confidentiality of data</span><p id="par0055" class="elsevierStylePara elsevierViewall">The authors declare that they have followed the protocols of their work center on the publication of patient data.</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Right to privacy and informed consent</span><p id="par0060" class="elsevierStylePara elsevierViewall">The authors have obtained the written informed consent of the patients or subjects mentioned in the article. The corresponding author is in possession of this document.</p></span></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0055">Conflicts of interest</span><p id="par0065" class="elsevierStylePara elsevierViewall">The authors have no conflicts of interest to declare.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:9 [ 0 => array:3 [ "identificador" => "xres856743" "titulo" => "Abstract" "secciones" => array:1 [ 0 => array:1 [ "identificador" => "abst0005" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec850776" "titulo" => "Keywords" ] 2 => array:3 [ "identificador" => "xres856742" "titulo" => "Resumo" "secciones" => array:1 [ 0 => array:1 [ "identificador" => "abst0010" ] ] ] 3 => array:2 [ "identificador" => "xpalclavsec850775" "titulo" => "Palavras-chave" ] 4 => array:2 [ "identificador" => "sec0005" "titulo" => "Case report" ] 5 => array:2 [ "identificador" => "sec0010" "titulo" => "Discussion" ] 6 => array:3 [ "identificador" => "sec0015" "titulo" => "Ethical disclosures" "secciones" => array:3 [ 0 => array:2 [ "identificador" => "sec0020" "titulo" => "Protection of human and animal subjects" ] 1 => array:2 [ "identificador" => "sec0025" "titulo" => "Confidentiality of data" ] 2 => array:2 [ "identificador" => "sec0030" "titulo" => "Right to privacy and informed consent" ] ] ] 7 => array:2 [ "identificador" => "sec0035" "titulo" => "Conflicts of interest" ] 8 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2016-04-03" "fechaAceptado" => "2016-09-05" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec850776" "palabras" => array:3 [ 0 => "Atrial septal defect" 1 => "Residual shunt" 2 => "Percutaneous intervention" ] ] ] "pt" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palavras-chave" "identificador" => "xpalclavsec850775" "palabras" => array:3 [ 0 => "Comunicação interauricular" 1 => "<span class="elsevierStyleItalic">Shunt</span> residual" 2 => "Intervenção percutânea" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:2 [ "titulo" => "Abstract" "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">A 39-year-old woman underwent uneventful percutaneous occlusion of an ostium secundum atrial septal defect (ASD) with a 22 mm Ultrasept ASD Occluder<span class="elsevierStyleSup">®</span>. Transesophageal echocardiography (TEE) performed two years after implantation revealed a de novo residual left-to-right shunt through the correctly implanted device. Three-dimensional transesophageal echocardiography (3D TEE) further clarified this finding by showing a perforation of the device membrane coating. The patient underwent transcatheter closure of the residual shunt with a 20 mm Ultrasept PFO<span class="elsevierStyleSup">®</span> device. The procedure was guided by fluoroscopy and real-time 3D TEE. At the end of the procedure 3D TEE documented correct device deployment with complete defect coverage and absence of residual shunt.</p></span>" ] "pt" => array:2 [ "titulo" => "Resumo" "resumen" => "<span id="abst0010" class="elsevierStyleSection elsevierViewall"><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Doente de 39 anos, género feminino, foi submetida com sucesso a encerramento percutâneo de comunicação interauricular do tipo <span class="elsevierStyleItalic">ostium secundum</span> com dispositivo <span class="elsevierStyleItalic">Ultrasept Atrial Septal Defect Occluder</span><span class="elsevierStyleSup">®</span> de 22 mm. O ecocardiograma transesofágico, realizado dois anos após implantação, revelou <span class="elsevierStyleItalic">shunt</span> esquerdo-direito residual de novo através do dispositivo corretamente implantado. O ecocardiograma transesofágico tridimensional (ETE3D) objetivou uma perfuração do revestimento do dispositivo. A doente foi submetida a encerramento percutâneo do <span class="elsevierStyleItalic">shunt</span> residual com dispositivo <span class="elsevierStyleItalic">UltraSept PFO Occluder</span><span class="elsevierStyleSup">®</span> de 20 mm. O procedimento foi guiado por fluoroscopia e ETE3D. No final do procedimento por ETE3D, foi documentado o correto posicionamento do dispositivo, com completa cobertura da perfuração e ausência de <span class="elsevierStyleItalic">shunt</span> residual.</p></span>" ] ] "multimedia" => array:1 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1914 "Ancho" => 3333 "Tamanyo" => 539931 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">(A and D) Three- (3D TEE) and two-dimensional transesophageal echocardiography images showing residual shunt through the device (22 mm Ultrasept ASD Occluder<span class="elsevierStyleSup">®</span>); (B and C) delivery sheath through the Ultrasept device in fluoroscopic view and in 3D TEE; (E and F) closure of residual shunt in the 22 mm Ultrasept device with a 20 mm Ultrasept PFO device, with the final result documented in fluoroscopic view and in 3D TEE.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:4 [ 0 => array:3 [ "identificador" => "bib0025" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Early malfunction of polyvinyl alcohol membrane-covered atrial septal defect closure devices" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:3 [ 0 => "P. Aubry" 1 => "E. Brochet" 2 => "X.H. du Fretay" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1161/CIRCINTERVENTIONS.114.001429" "Revista" => array:6 [ "tituloSerie" => "Circ Cardiovasc Interv" "fecha" => "2014" "volumen" => "7" "paginaInicial" => "721" "paginaFinal" => "722" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/25336605" "web" => "Medline" ] ] ] ] ] ] ] ] 1 => array:3 [ "identificador" => "bib0030" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Device failure weeks to months after transcatheter closure of secundum type atrial septal defects" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:3 [ 0 => "T. Bartel" 1 => "N. Bonaros" 2 => "S. Müller" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1136/hrt.2009.185942" "Revista" => array:5 [ "tituloSerie" => "Heart" "fecha" => "2010" "volumen" => "96" "paginaInicial" => "1603" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/20736198" "web" => "Medline" ] ] ] ] ] ] ] ] 2 => array:3 [ "identificador" => "bib0035" "etiqueta" => "3" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Incomplete endothelialization and late dislocation after implantation of an Amplatzer septal occluder device" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:3 [ 0 => "F. Chen" 1 => "X. Zhao" 2 => "X. Zheng" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1161/CIRCULATIONAHA.110.991836" "Revista" => array:6 [ "tituloSerie" => "Circulation" "fecha" => "2011" "volumen" => "124" "paginaInicial" => "e188" "paginaFinal" => "e189" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/21824928" "web" => "Medline" ] ] ] ] ] ] ] ] 3 => array:3 [ "identificador" => "bib0040" "etiqueta" => "4" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Clinical, echocardiographic and histopathologic findings in nine patients with surgically explanted ASD/PFO devices: do we know enough about the healing process in humans?" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:3 [ 0 => "M.O. Vogt" 1 => "A. Kühn" 2 => "J. Hörer" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1016/j.ijcard.2009.09.544" "Revista" => array:6 [ "tituloSerie" => "Int J Cardiol" "fecha" => "2011" "volumen" => "147" "paginaInicial" => "398" "paginaFinal" => "404" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/19896735" "web" => "Medline" ] ] ] ] ] ] ] ] ] ] ] ] ] "idiomaDefecto" => "en" "url" => "/08702551/0000003600000006/v2_201706240150/S0870255117303505/v2_201706240150/en/main.assets" "Apartado" => array:4 [ "identificador" => "29263" "tipo" => "SECCION" "en" => array:2 [ "titulo" => "Casos Clínicos" "idiomaDefecto" => true ] "idiomaDefecto" => "en" ] "PDF" => "https://static.elsevier.es/multimedia/08702551/0000003600000006/v2_201706240150/S0870255117303505/v2_201706240150/en/main.pdf?idApp=UINPBA00004E&text.app=https://revportcardiol.org/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0870255117303505?idApp=UINPBA00004E" ]
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