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27

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149256001A_EN_ES_PT  16.2.2005  14:30 Uhr  Seite 27

Содержание 3000TFX PERIMOUNT Magna Aortic

Страница 1: ...logy and mechanics of natural heart valves and reported experience with implantation of unstented homografts Refs 5 7 The lightweight wireform frame is made of Elgiloy a corrosion resistant alloy chos...

Страница 2: ...ons chemicals antibiotics etc except for the storage solution or sterile physiological saline solution as irreparable damage to the leaflet tissue may result that is not apparent under visual inspecti...

Страница 3: ...ression of the valve orifice When using interrupted sutures it is important to cut the sutures close to the knots and to ensure that exposed suture tails will not come into contact with the leaflet ti...

Страница 4: ...available on 719 patients requiring isolated aortic valve replacement AVR with the Model 2700 Carpentier Edwards pericardial bioprosthesis with mean follow up of 3 9 years indicate overall actuarial...

Страница 5: ...HA functional classification has also been demonstrated postoperatively Forty five percent of the patients are in NYHA Functional Class I at 12 years post implant with the Carpentier Edwards pericardi...

Страница 6: ...should contain enough buffered glutaraldehyde storage solution to cover the prosthesis The contents of the jar should be handled in an aseptic manner to prevent contamination Using gloved hand attach...

Страница 7: ...recautions Caution Because of the intense temperature and lighting conditions in the operating field the bioprosthesis should be irrigated frequently every 1 to 2 minutes is recommended on both sides...

Страница 8: ...ion is not necessary under these circumstances 12 Patient Information 12 1 Registration Information An Implantation Data Card is included in each device package for patient registration After implanta...

Страница 9: ...nte en pacientes con ra ces a rticas peque as se ha reducido el di metro de la biopr tesis peric rdica PERIMOUNT Magna de Carpentier Edwards 2 Indicaciones de uso Las v lvulas peric rdicas est n indic...

Страница 10: ...entre 2 y 3 meses Transcurrido este per odo se debe suspender el uso de anticoagulantes durante un per odo de 10 d as excepto en aquellos pacientes para los que est indicada una protecci n anticoagula...

Страница 11: ...s que contengan calcio en el postoperatorio as como la ingesti n excesiva de leche y derivados l cteos en los ni os Los estudios realizados en animales ref 11 demuestran que la concentraci n elevada d...

Страница 12: ...alg n familiar o el m dico de su zona En la tabla 1 se resumen los porcentajes de complicaciones operatorias y postoperatorias en la poblaci n sometida a AVR aislada y a DVR Los porcentajes de complic...

Страница 13: ...ds Lifesciences LLC One Edwards Way Irvine CA 92614 5686 EE UU 8 Individualizaci n del tratamiento Los receptores de v lvulas card acas bioprot sicas deber n someterse a terapia de anticoagulaci n exc...

Страница 14: ...por s sola del 100 contra todos los posibles contaminantes No se debe intentar volver a esterilizar la biopr tesis peric rdica PERIMOUNT Magna de Carpentier Edwards Precauci n Tanto la v lvula como l...

Страница 15: ...i n intra anular se puede utilizar el extremo cil ndrico o de la r plica de la v lvula del calibrador modelo 1130 Para realizar la calibraci n correctamente el calibrador debe estar paralelo al plano...

Страница 16: ...olver una v lvula recuperada p ngase en contacto con su especialista local en v lvulas Las v lvulas explantadas deber n colocarse en un fijador histol gico adecuado como formol al 10 o glutaraldeh do...

Страница 17: ...tier Edwards foi reduzido para facilitar a implanta o em doentes com ra zes a rticas pequenas 2 Indica es de Utiliza o As v lvulas peric rdicas est o indicadas para utiliza o em doentes que sofram de...

Страница 18: ...vulares card acas devem receber uma profilaxia antibi tica adequada durante tratamentos odontol gicos a fim de reduzir o risco de infec o da pr tese Os portadores de pr teses biol gicas valvulares car...

Страница 19: ...r ser devolvida sem ser utilizada Esta etiqueta n o dever ser separada da v lvula at imediatamente antes da implanta o Dever se ter cuidado para evitar cortar ou rasgar o tecido do anel de sutura dura...

Страница 20: ...tando de dupla substitui o da v lvula DSV com um acompanhamento m dio de 3 7 anos indicam uma taxa actuarial global de sobreviv ncia a 6 anos de 67 2 6 5 Estes dados do grupo de doentes pr aprova o fo...

Страница 21: ...doentes que necessitaram de nova opera o explante e a disfun o valvular foi a causa de morte em dois doentes Embora a taxa de sobreviv ncia global dos doentes seja de 45 a 12 anos a taxa de aus ncia d...

Страница 22: ...o por parte do cliente ser o considerados como fruto da exposi o a condi es ambientais da responsabilidade do cliente e como tal ser o sujeitos a substitui o a cargo do cliente 10 3 Conserva o As pr t...

Страница 23: ...as que o cirurgi o considere necess rias 2 Retirar cirurgicamente as calcifica es do annulus a fim de obter um alojamento adequado do anel de sutura 3 Medir o tamanho do annulus utilizando exclusivame...

Страница 24: ...mente a geometria do anel de sutura da v lvula Figura 4b No outro lado do punho existe uma extremidade de r plica da v lvula que reflecte a geometria do anel de sutura da v lvula assim como a altura e...

Страница 25: ...am se a utiliza o para os registos hospitalares e do cirurgi o Quando o Registo de Implantes em Doentes receber o cart o ser emitido um cart o de identifica o tamanho carteira que ser enviado ao doent...

Страница 26: ...ke Medical Books New York 1982 pp 25 34 17 Ferrans V J et al Structural Changes in Glutaraldehyde Treated Porcine Heterografts Used as Substitute Cardiac Valves Am J Cardiol 41 1159 1184 1978 18 Forfa...

Страница 27: ...cation of Tissue Heart Valve Prostheses J Thorac Cardiovasc Surg 62 5 683 689 and 693 695 1971 48 Relland J et al The Third Generation Carpentier Edwards Bioprosthesis Early Results JACC 6 5 1149 1154...

Страница 28: ...5 mm 27 mm 29 mm A Di metro del stent malla 19 21 23 25 27 29 B Di metro interior D I del stent 18 20 22 24 26 28 C Altura del perfil 14 15 16 17 18 19 D Di metro del anillo de sutura externo 24 26 28...

Страница 29: ...5 1 0 0 0 8 NA Segunda intervenci n relacionada con la v lvula 0 7 0 1 99 8 0 4 0 0 NA Todas las segundas intervenciones 22 4 1 8 75 4 1 8 34 3 2 3 NA Tromboembolismo relacionado con la v lvula 3 1 1...

Страница 30: ...9 2 Velocidad M seg media D E 2 80 0 49 2 56 0 46 2 36 0 42 2 15 0 56 2 09 0 27 2 08 0 1 2 46 0 50 n 12 21 15 7 3 3 61 rango 1 90 3 60 1 90 3 90 1 39 2 86 1 00 2 60 1 90 2 40 2 05 2 10 1 00 3 90 Pico...

Страница 31: ...acia grados funcionales de la NYHA modelo 2700 Preoperatorio Postoperatorio Clase funcional NYHA Clase funcional NYHA No I II III IV Expiraci n disponible I 18 19 9 II 140 37 35 15 III 181 48 4 1 72 2...

Страница 32: ...icaci n N de incidencias N de incidencias Tromboembolismo Trombo 8 3 0 31 1 45 Endocarditis 0 0 7 0 33 Disfunci n de la v lvula 1 0 37 34 1 60 Fuga perivalvular 1 0 37 4 0 19 Complicaci n por anticoag...

Страница 33: ...ra 3 A rtico CP1036 45 Figure 4a Aortic Sizer Figura 4a Calibrador a rtico Figura 4a Medidor A rtico CP1036 33 Figure 1 Aortic Figura 1 A rtica Figura 1 A rtico CP1036 46 CP1036 48 CP1036 47 Figure 2...

Страница 34: ...Medi o Intra Anular CP1036 39 CP1036 40 Figure 6b Intra Annular Measurement Figura 6b Calibraci n intra anular Figura 6b Medi o Intra Anular CP1036 32 Figure 6c Intra Annular Placement Figura 6c Coloc...

Страница 35: ...vapor o calor vapore o a door stoom of eller t rsteriliseret med nga eller por Vapor Dry Heat la chaleur s che trockener W rme seco calore secco droge warmte torrv rme ou Calor Seco Serial Number Num...

Страница 36: ...es LLC One Edwards Way Irvine CA 92614 5686 USA 01 05 149256001 Rev A Copyright 2005 Edwards Lifesciences LLC All rights reserved 149256001A Edwards Lifesciences Services GmbH Edisonstr 6 D 85716 Unte...

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