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congestive HF&#44; worsening left ventricular function or progressive left ventricular dilatation&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">The severity of the regurgitant jet&#40;s&#41; is not as important as the clinical repercussions of regurgitation&#46; For this reason&#44; even PVLs with mild or moderate regurgitation on echocardiographic criteria should be treated if they are associated with hemolysis&#44; HF&#44; or progressive left ventricular dilatation&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">3</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">Following transcatheter valve replacement&#44; intermediate-risk patients with mild PVL usually have a benign clinical course&#44; but mortality is higher in patients at higher risk and with comorbidities at two-year follow-up&#46;<a class="elsevierStyleCrossRefs" href="#bib0100"><span class="elsevierStyleSup">4&#8211;6</span></a></p><p id="par0030" class="elsevierStylePara elsevierViewall">Medical treatment is merely palliative&#44; and until recently the only option for patients with clinical indication for PVL closure was surgical correction&#46; Various closure techniques have been described&#44; including direct suturing and placement of autologous tissue or patches&#44; but all these options have high failure rates&#44; ranging from 12 to 35&#37;&#46; In-hospital mortality is also high&#44; particularly in cases of reintervention&#44; such as the 12-37&#37; seen in a series of 618 surgical reinterventions by Echevarria et al&#46;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">7</span></a></p><p id="par0035" class="elsevierStylePara elsevierViewall">The first percutaneous PVL closure was reported by Hourihan et al&#46;<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">8</span></a> in 1992&#44; and since then several small series have been published&#46; In a recent meta-analysis including 362 patients&#44; the procedural success rate was 76&#46;5&#37;&#44; and procedural success was accompanied by lower cardiac mortality during follow-up &#40;odds ratio &#91;OR&#93;&#58; 0&#46;08&#44; 95&#37; confidence interval &#91;CI&#93;&#58; 0&#46;01-0&#46;9&#41;&#44; fewer surgical reinterventions &#40;OR&#58; 0&#46;08&#44; 95&#37; CI&#58; 0&#46;01-0&#46;4&#41; and improvements in HF and hemolytic anemia&#46;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">9</span></a> The 30-day incidence of major adverse events &#40;death&#44; myocardial infarction&#44; stroke&#44; major bleeding and urgent surgery&#41; is less than 10&#37;&#44; which compares favorably with surgery&#46;<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">10</span></a> Embolization of closure devices is a rare complication and very few cases of late embolization have been reported&#46;<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">11</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">Closure of aortic PVLs is usually technically simpler&#44; with only one access route&#44; and echocardiographic support is not as crucial as with the mitral valve&#44; for which various access routes can be used &#40;antegrade transseptal&#44; retrograde transaortic and transapical&#41; and for which the assistance of imaging techniques other than angiography&#44; such as three-dimensional transesophageal echocardiography&#44; is essential&#46; New modalities have recently been developed&#44; integrating images with fusion technology &#40;tomography&#44; angiography and echocardiography&#41;&#44; such as Philips Medical Systems&#8217; HeartNavigator and EchoNavigator&#46;<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">12</span></a> Certain locations of mitral PVL&#44; particularly medial or septal&#44; are extremely challenging&#44; for which steerable sheaths such as the Agilis NxT &#40;St&#46; Jude Medical&#41; or an arteriovenous loop may be useful&#44; and in some cases the best option could be a transapical approach&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">Another factor that is crucial to success in these procedures is operator experience&#59; complications decrease and success rates rise as the operator gains experience&#46;<a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">13</span></a> This experience should be concentrated in a reference center and in an operator trained in structural cardiac intervention&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">With regard to the devices used for PVL closure&#44; the choice is determined by what is available in a given center and a particular country&#44; and is also influenced by the operator&#39;s experience with specific devices in other types of structural intervention&#46; Some case series deal with a single device&#44; as in the series by Cruz-Gonz&#225;lez et al&#46; with the Amplatzer Vascular Plug &#40;AVP&#41; III &#40;St&#46; Jude Medical&#41;&#44; in which success rates were over 90&#37;&#46;<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">14</span></a> However&#44; most series are based on more than one device&#46; The most popular is the AVP II &#40;St&#46; Jude Medical&#41;&#44; which has been approved by the US Food and Drug Administration&#46;<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">14</span></a> The sizes most often used are between 8 mm and 12 mm for the AVP II&#44; which is round in shape and thus permits the implantation of more than one device&#46; Furthermore&#44; it makes more sense to implant multiple small devices rather than a single large one&#44; since this is more likely to result in complete closure and less likely to interfere with the prosthetic valve&#46;<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">10</span></a></p><p id="par0055" class="elsevierStylePara elsevierViewall">In cases of PVL following transcatheter aortic valve implantation&#44; the device most often used is the AVP IV&#44; but success rates are lower &#40;around 60&#37;&#41;&#44; mainly due to difficulty in cannulating the leak&#46; New devices have recently been developed that are specifically designed for PVLs&#44; such as the Occlutech PLD<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">15</span></a> &#40;which comes in rectangular and square forms&#41;&#44; but their use is currently limited to small series &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Figure 1</a>&#41;&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0060" class="elsevierStylePara elsevierViewall">The series by Azevedo et al&#46;<a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">16</span></a> published in this issue of the <span class="elsevierStyleItalic">Journal</span> presents the experience of a single center treating different types of patients with mechanical and biological valves&#44; aortic and mitral PVL&#44; and a variety of devices&#46; The results are generally good and are consistent with larger previously published series&#46; Given the small numbers of patients treated in each Portuguese center&#44; it is important to establish prospective&#44; multicenter national registries that collect information systematically&#44; to shed more light on this therapeutic alternative&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">It would be difficult to perform studies specifically designed to provide evidence on which to base future recommendations on this subject&#44; but it is clear that the good results of percutaneous PVL closure compared to the surgical alternative already make it the first-line treatment for clinically relevant PVL&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">3</span></a></p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicts of interest</span><p id="par0070" class="elsevierStylePara elsevierViewall">The author has no conflicts of interest to declare&#46;</p></span></span>"
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        "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as&#58; Costa M&#46; Encerramento percut&#226;neo de <span class="elsevierStyleItalic">leaks</span> periprot&#233;sicos &#8211; deve ser considerada como a primeira op&#231;&#227;o terap&#234;utica&#63; Rev Port Cardiol&#46; 2017&#59;36&#58;495&#8211;497&#46;</p>"
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          "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Examples of devices used for percutaneous paravalvular leak closure&#58; &#40;1&#41; Amplatzer Vascular Plug II&#59; &#40;2&#41; Amplatzer Vascular Plug III&#59; &#40;3&#41; Amplatzer Vascular Plug IV&#59; &#40;4&#41; Amplatzer Duct Occluder&#59; &#40;5&#41; Amplatzer Muscular VSD Occluder&#59; &#40;6&#41; Amplatzer Septal Occluder&#59; &#40;7&#41; Occlutech PLD &#40;square&#41;&#59; &#40;8&#41; Occlutech PLD &#40;rectangular&#41;&#46;</p>"
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Editorial comment
Percutaneous closure of prosthetic paravalvular leaks – Should it be considered the first therapeutic option?
Encerramento percutâneo de leaks periprotésicos – deve ser considerada como a primeira opção terapêutica?
Marco Costa
Serviço de Cardiologia, Hospital Geral, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Paravalvular leak &#40;PVL&#41; is one of the most common complications of surgical implantation of mechanical or biological valve prostheses and&#44; more recently&#44; with percutaneous valve replacement&#46; Its incidence ranges&#44; according to the series&#44; between 2 and 10&#37; for aortic valves and 7 and 17&#37; for mitral valves&#46;<a class="elsevierStyleCrossRefs" href="#bib0085"><span class="elsevierStyleSup">1&#44;2</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Although most patients with PVL have few or no symptoms and are accordingly treated conservatively&#44; some leaks can lead to an unfavorable clinical outcome&#44; including heart failure &#40;HF&#41;&#44; hemolytic anemia or death&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">It is now accepted that PVLs should be closed if associated with hemolytic anemia&#44; congestive HF&#44; worsening left ventricular function or progressive left ventricular dilatation&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">The severity of the regurgitant jet&#40;s&#41; is not as important as the clinical repercussions of regurgitation&#46; For this reason&#44; even PVLs with mild or moderate regurgitation on echocardiographic criteria should be treated if they are associated with hemolysis&#44; HF&#44; or progressive left ventricular dilatation&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">3</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">Following transcatheter valve replacement&#44; intermediate-risk patients with mild PVL usually have a benign clinical course&#44; but mortality is higher in patients at higher risk and with comorbidities at two-year follow-up&#46;<a class="elsevierStyleCrossRefs" href="#bib0100"><span class="elsevierStyleSup">4&#8211;6</span></a></p><p id="par0030" class="elsevierStylePara elsevierViewall">Medical treatment is merely palliative&#44; and until recently the only option for patients with clinical indication for PVL closure was surgical correction&#46; Various closure techniques have been described&#44; including direct suturing and placement of autologous tissue or patches&#44; but all these options have high failure rates&#44; ranging from 12 to 35&#37;&#46; In-hospital mortality is also high&#44; particularly in cases of reintervention&#44; such as the 12-37&#37; seen in a series of 618 surgical reinterventions by Echevarria et al&#46;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">7</span></a></p><p id="par0035" class="elsevierStylePara elsevierViewall">The first percutaneous PVL closure was reported by Hourihan et al&#46;<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">8</span></a> in 1992&#44; and since then several small series have been published&#46; In a recent meta-analysis including 362 patients&#44; the procedural success rate was 76&#46;5&#37;&#44; and procedural success was accompanied by lower cardiac mortality during follow-up &#40;odds ratio &#91;OR&#93;&#58; 0&#46;08&#44; 95&#37; confidence interval &#91;CI&#93;&#58; 0&#46;01-0&#46;9&#41;&#44; fewer surgical reinterventions &#40;OR&#58; 0&#46;08&#44; 95&#37; CI&#58; 0&#46;01-0&#46;4&#41; and improvements in HF and hemolytic anemia&#46;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">9</span></a> The 30-day incidence of major adverse events &#40;death&#44; myocardial infarction&#44; stroke&#44; major bleeding and urgent surgery&#41; is less than 10&#37;&#44; which compares favorably with surgery&#46;<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">10</span></a> Embolization of closure devices is a rare complication and very few cases of late embolization have been reported&#46;<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">11</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">Closure of aortic PVLs is usually technically simpler&#44; with only one access route&#44; and echocardiographic support is not as crucial as with the mitral valve&#44; for which various access routes can be used &#40;antegrade transseptal&#44; retrograde transaortic and transapical&#41; and for which the assistance of imaging techniques other than angiography&#44; such as three-dimensional transesophageal echocardiography&#44; is essential&#46; New modalities have recently been developed&#44; integrating images with fusion technology &#40;tomography&#44; angiography and echocardiography&#41;&#44; such as Philips Medical Systems&#8217; HeartNavigator and EchoNavigator&#46;<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">12</span></a> Certain locations of mitral PVL&#44; particularly medial or septal&#44; are extremely challenging&#44; for which steerable sheaths such as the Agilis NxT &#40;St&#46; Jude Medical&#41; or an arteriovenous loop may be useful&#44; and in some cases the best option could be a transapical approach&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">Another factor that is crucial to success in these procedures is operator experience&#59; complications decrease and success rates rise as the operator gains experience&#46;<a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">13</span></a> This experience should be concentrated in a reference center and in an operator trained in structural cardiac intervention&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">With regard to the devices used for PVL closure&#44; the choice is determined by what is available in a given center and a particular country&#44; and is also influenced by the operator&#39;s experience with specific devices in other types of structural intervention&#46; Some case series deal with a single device&#44; as in the series by Cruz-Gonz&#225;lez et al&#46; with the Amplatzer Vascular Plug &#40;AVP&#41; III &#40;St&#46; Jude Medical&#41;&#44; in which success rates were over 90&#37;&#46;<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">14</span></a> However&#44; most series are based on more than one device&#46; The most popular is the AVP II &#40;St&#46; Jude Medical&#41;&#44; which has been approved by the US Food and Drug Administration&#46;<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">14</span></a> The sizes most often used are between 8 mm and 12 mm for the AVP II&#44; which is round in shape and thus permits the implantation of more than one device&#46; Furthermore&#44; it makes more sense to implant multiple small devices rather than a single large one&#44; since this is more likely to result in complete closure and less likely to interfere with the prosthetic valve&#46;<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">10</span></a></p><p id="par0055" class="elsevierStylePara elsevierViewall">In cases of PVL following transcatheter aortic valve implantation&#44; the device most often used is the AVP IV&#44; but success rates are lower &#40;around 60&#37;&#41;&#44; mainly due to difficulty in cannulating the leak&#46; New devices have recently been developed that are specifically designed for PVLs&#44; such as the Occlutech PLD<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">15</span></a> &#40;which comes in rectangular and square forms&#41;&#44; but their use is currently limited to small series &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Figure 1</a>&#41;&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0060" class="elsevierStylePara elsevierViewall">The series by Azevedo et al&#46;<a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">16</span></a> published in this issue of the <span class="elsevierStyleItalic">Journal</span> presents the experience of a single center treating different types of patients with mechanical and biological valves&#44; aortic and mitral PVL&#44; and a variety of devices&#46; The results are generally good and are consistent with larger previously published series&#46; Given the small numbers of patients treated in each Portuguese center&#44; it is important to establish prospective&#44; multicenter national registries that collect information systematically&#44; to shed more light on this therapeutic alternative&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">It would be difficult to perform studies specifically designed to provide evidence on which to base future recommendations on this subject&#44; but it is clear that the good results of percutaneous PVL closure compared to the surgical alternative already make it the first-line treatment for clinically relevant PVL&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">3</span></a></p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicts of interest</span><p id="par0070" class="elsevierStylePara elsevierViewall">The author has no conflicts of interest to declare&#46;</p></span></span>"
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        "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as&#58; Costa M&#46; Encerramento percut&#226;neo de <span class="elsevierStyleItalic">leaks</span> periprot&#233;sicos &#8211; deve ser considerada como a primeira op&#231;&#227;o terap&#234;utica&#63; Rev Port Cardiol&#46; 2017&#59;36&#58;495&#8211;497&#46;</p>"
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          "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Examples of devices used for percutaneous paravalvular leak closure&#58; &#40;1&#41; Amplatzer Vascular Plug II&#59; &#40;2&#41; Amplatzer Vascular Plug III&#59; &#40;3&#41; Amplatzer Vascular Plug IV&#59; &#40;4&#41; Amplatzer Duct Occluder&#59; &#40;5&#41; Amplatzer Muscular VSD Occluder&#59; &#40;6&#41; Amplatzer Septal Occluder&#59; &#40;7&#41; Occlutech PLD &#40;square&#41;&#59; &#40;8&#41; Occlutech PLD &#40;rectangular&#41;&#46;</p>"
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ISSN: 21742049
Original language: English
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Revista Portuguesa de Cardiologia (English edition)
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