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7

Supra-annular sizing and implantation:

Using supra-annular technique, the sewing ring of the valve
is placed above the annulus, maximizing valve orifice area.
A larger valve size can often be implanted using a supra-
annular technique compared to an intra-annular technique.
This increase in prosthetic valve size provides improved
hemodynamic performance. For optimal implantation of the
valve in the supra-annular position, the sizer should be
parallel with the plane of the annulus and the following
sizing technique should be used:

Step 1: Using the Model 1130 sizer, select the cylindrical end
of the largest diameter sizer that comfortably fits in the
patient’s annulus (Figure 5a).
Step 2: Once you have verified the appropriate cylindrical end,
use the replica end of the same sizer to verify that the sewing
ring will fit comfortably on top of the annulus (Figure 5b).
Step 3: Determine if upsizing of the valve is possible by using
the replica end of the 

next largest sizer

(Figure 5c). Ensure

that the coronary ostia are not obstructed and that the valve
stent posts do not interfere with the aortic wall at the
sinotubular junction (Figure 5d). If this larger size replica end
fits comfortably, implant this size of the PERIMOUNT Magna
valve. If this larger size replica end does not fit comfortably,
implant the valve size identified by Step 2.

A suture technique resulting in supra-annular placement of
the valve, such as a horizontal mattress technique, should
be employed.

Intra-annular sizing and implantation:

Using intra-annular technique, the entire valve including the
sewing ring is placed inside the annulus. Either the
cylindrical or valve replica end of the Model 1130 sizer can
be used for intra-annular sizing.

For proper sizing, the sizer should be parallel with the plane
of the annulus and the entire sizer, including the simulated
sewing ring portion, should pass through the annulus.
(Figure 6a-6c). A suture technique resulting in intra-annular
placement of the valve, such as an everting mattress
technique, should be employed.

4. Suture the valve in place using an appropriate suture technique

that avoids the potential problems noted under 

5. Precautions

.

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 with sterile physiological saline to keep the
valve moist during the implant procedure.

Handle/Holder Removal

The integral holder and attached handle are removed as a unit
at the completion of the suturing procedure in the following
manner (see Figure 3):

1. Using a scalpel or scissors as shown, cut each of the three

exposed sutures that are on the surface of the holder.

Caution: Avoid cutting or damaging the stent or delicate
leaflet tissue when cutting the sutures.

2. When all three attaching sutures have been properly cut,

remove the handle/holder assembly, along with the
attaching sutures, from the valve as a unit.

3. Following surgery, remove the holder from the handle and

discard the holder. If using Model 1111 handle clean and
sterilize the handle before each use.

11.4 Accessories

Sizers

The use of a sizing instrument facilitates selection of the
correct size valve for implantation. Model 1130 sizers are
fabricated from translucent polysulfone plastic to permit direct
observation of their fit within the annulus. The Model 1130
sizer was developed to facilitate accurate sizing of the
Carpentier-Edwards PERIMOUNT Magna model 3000TFX valve
in a wide range of patients. Each sizer consists of a handle with
a different sizer configuration at each end (Figure 4a). On one
side of the handle is a cylindrical end with an integrated lip that
accurately reflects the valve sewing ring geometry (Figure 4b).
On the other side of the handle is a valve replica end that
reflects the valve sewing ring geometry as well as the height
and location of the stent posts (Figure 4c). A sizer is available
for each size of the PERIMOUNT Magna model 3000TFX valve
(19, 21, 23, 25, 27 and 29 mm). The limits of accuracy for the
Model 1130 sizer are ±0.127 mm.

Valve Holder and Handle

The handle/holder assembly consists of two components: an
integral disposable part that is physically mounted to the valve
by the manufacturer, and a 

malleable

handle (reusable Model

1111 or disposable Model 1126 for single use) that is attached
to the holder at the time of surgery.

Caution: The Model 1126 disposable handle is supplied
sterile for single use and must not be resterilized.

149256001A_EN_ES_PT  16.2.2005  14:30 Uhr  Seite 7

Summary of Contents for 3000TFX PERIMOUNT Magna Aortic

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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