El
diseño versátil del
C-P Stent
permite tratar varias obstrucciones
vasculares especificas, asociadas con las cardiopatías congénitas,
especialmente en niños.
El
sistema de colocación
BIB, balón dentro del balón, ha mejorado la
seguridad y eficacia al colocar el stent, en contraste con otros sistemas
disponibles.
CHEATHAM-PLATINUM
C-PSTENT
DE NuMED.
Fabricado
en alambre temperado de platino-iridio.
(Click
en la imagen para más datos)
BIB
(BALLOON-IN-BALLOON) DE
NuMED
para
la colocación del C-P Stent
(Click
en la imagen para más datos)
CP
STent en CHD
Initial
Experience Using the NuMED
Cheatham Platinum (CP) Stent
and a New Balloon Delivery Catheter in Children and Adults
with Congenital Heart Disease.
Presenter:
John P. Cheatham, MD, FSCAI
Joint
Division of Pediatric Cardiology
University
of Nebraska and Creighton University
Children’s
Hospital
Omaha,
Nebraska
Sponsor:
Allen J. Tower, President
NuMED,
Inc.
Hopkinton,
New York
PARTICIPANTS
Carlos
E. Ruiz, MD, Rush Children’s Heart Center, Chicago, IL, USA
Yousef
Goussous, MD & Fakhri Hakim, MD, Queen Alia Heart Institute @ King
Hussein Medical Center, Amman, Jordan
William
Torres, MD, ASCARDIO, Barquisimeto, Venezuela
Jack
Bandel, MD, Clinicas Caracas, Caracas, Venezuela
Charles
E. Mullins, MD, Texas Children’s Hospital, Houston, TX, USA
Leopoldo
Hernandez, MD, Santiago, Chili
Neil
Wilson, MD, Royal Hospital for Sick Children, Glasgow, Scotland
Luiz
Christiani, MD, Cardio Barra Clinicas, Rio de Janeiro, Brazil
Helder
Pauperio, MD, SOCOR Hospital Geral, Belo Horizonte, Brazil
Antonio
Carvalho, MD, Escola Paulista Medicina, Sao Paulo, Brazil
Cesar
Esteves, MD, Instituto Dante Pazzanese De Cardiologia, Sao Paulo, Brazil
Ziyad
M. Hijazi, MD, Tufts New England Medical Center, Boston, MA, USA
Luigi
Ballerini, MD & Roberto Formigari, MD, Ospedale Pediatrico Bambino Gesu,
Rome, Italy
Ramon
Bermudez-Canete, Ramon Y Cajal Hospital, Madrid, Spain
PURPOSE
u
To
desing a ballon expandable intravascular stent that is both
specific for and versatile enough to treat the various vascular obstructions
associated with congenital heart disease
To
improve the safety and efficacy of the ballon delivery s system
when deploying intravascular stents
BACKGROUND
Palmaz
Stent: Limitations and Disadvantages
uDesigned
for adult peripheral vascular obstructions … not CHD
uRigid,
sharp-edged, stainless steel endoprosthesis
vDifficult
to deliver in tortuous vessels
vTendency
to rupture balloon, ? vascular injury
uSlot
design causes significant stent shortening
vAt
recommended expanded diameters: < 33% @ 12 mm
vWhen
“overexpanded”: >
50% @ 18 mm
uLimited
range of expanded diameters and lengths
v?
Unsuitable for aorta, pulmonary arteries, systemic veins
Single
Balloon Delivery System
uBalloon
is chosen longer than stent to avoid stent migration, unfortunately ...
Excessve
"flaring of stent"-->
trauma to balloon, vessel
uLeads
to stent migration and catheter movement
uNo
ability to reposition stent during delivery
GOALS
NuMED
Cheatham Platinum (CP) Stent
uExpand
from 8 mm to 24 mm
uA
wider selection of stent lengths
uShorten
< 20% at full expansion
uAtraumatic
round leading and trailing edges
uMore
“flexible”, yet stronger than Palmaz Stent
NuMED
Balloon In Balloon (BIB) Catheter
uMinimize
stent flaring, migration
uMinimize
catheter movement
uAllow
stent repositioning
Maintain current
or 1 Fr size larger introducer sheath
NuMED
CP STENT DEVELOPMENT
uCollaborative effort initiated in Nov. 1996
uComposition: 90% platinum/10% iridium 0.013”
wire
vHeat tempered to improve strength, “handling”
characteristics
uDesign: Zig pattern in rows, laser welded together
Variable
number of zigs: determines maximum expansion diameter while allowing
< 20% stent shortening
·6
Z < 16 mm, 8 Z < 24 mm, 10Z < 30mm
vVariable # of rows: determines stent length
·11, 16, 22, 28, 34, 39, 45, 50 mm ...
NuMED
BIB CATHETER DEVELOPMENT
uCollaborative
effort initiated in Nov. 1997
uInner
balloon < C-P
Stent
length
vTyshak
material, low profile
vExpands
to 1/2 diameter of outer balloon
uOuter
balloon >
C-P
Stent
length
vLength
is 1 cm longer than inner balloon
vExpands
to desired diameter to treat lesion
uCatheter
shaft diameters: 8 Fr, 9 Fr
NuMED
C-P Stent
TESTING
uPrevious
biocompatibility, corrosion, and fatigue testing
uBench:
compression strength, % shortening, introducer size
uIn
vitro animal vessel (canine, porcine)
uIn
vivo animal (canine): acute & chronic studies
SUBJECTS
uStudy
years: August 1998 - April 1999
u32
patients: 18 males, 14 females
vAge:
1.8-60, 19.5 yrs
vWeight:
10-93.2, 57.7 kg
vDiagnoses
·CoA
(17): Native - 11, Recurrent - 6
·RPA
stenosis (4): P/O TOF - 3, P/O PA/IVS with BTS - 1
·LPA
stenosis (1): P/O TOF
·RPA/LPA
stenoses (5): P/O TOF- 4, P/O TGA switch -1
·RV-PA
homograft stenosis (2): P/O TOF - 2
·R
BTS stenosis (1): P/O complex CHD
·Lateral
tunnel Fontan leak (1): P/O complex CHD
·SVC
baffle obstruction (1): P/O TGA Mustard
MATERIALS
C-P Stent
implanted - 42
CoA-
17
RPA
- 4
LPA
- 1
RPA/LPA
- 12 (kissing stents)
6
Zig: 22-28 mm long (6)
7
Zig: 45 mm long (1)
8
Zig: 22-50 mm long (34)
10
Zig: 117 mm long (1)
Covered
3 C-P
Stent
with
stretched PTFE
P/O
CoA with complete Ao obstruction
Severe
native CoA (< 2 mm)
Lateral
tunnel Fontan with multiple sites of R ®
L shunt
BIB
Catheters:
Inner/Outer Balloon Diameters (mm)
5/10
- 3
6/12
- 6
7/14
- 4
8/16
- 11
Introducer
Sheaths (Mullin’s Type)
Cook
RCF: 10-14 Fr
14,16,
18/22 Fr for 3 covered
C-P Stent
Super
Arrow-Flex™: 10-11 Fr
METHODS
Informed
consent and IRB/Ethical Committee approval
Intravenous
heparin and prophylactic antibiotics
Hemodynamic
and angiographic studies
Measure
target lesion and surrounding vessels
Determine
desired & ultimate expanded diameter & length of
C-P Stent
Determines
the proper # of Zigs and length of
C-P Stent
·Determines
BIB
catheter
Prepare
BIB
catheter
Mount
C-P
Stent
(always confirm on fluoro BEFORE
crimping)
Crimping:
finger pressure & “rolling” of stent
Mullin’s
“glue”
Always
inflate inner balloon first ®
maintain pressure ®
inflate
outer balloon
COMPLICATIONS
uLeft
hemothorax after covered C-P
Stent
in severe native CoA
(1)
vF/U
- Spontaneously resolved, no sequelae
uCP
stent fracture during traumatic insertion through skin (1)
vAttempted
“front load” of covered 10 Zig-117 mm CP stent
vLoop
snared stent fragment - no sequelae
* Dr. Wilson ®
I Blew
It Session!
**
No stent migration, flaring
**
No catheter movement
**
No balloon rupture
FOLLOW-UP
Limited
secondary to short time since implant
uNo
stent fractures
uNo
CoA arm/leg BP gradient > 10 mmHg
All patients
taking antiplatelet therapy
Follow-up
arranged with local pediatric cardiologist
uData
to be sent to NuMED,
Inc.
CONCLUSIONS
©The
NuMED
C-P
Stent
offers an effective, nonsurgical treatment for a wide variety of
vascular obstructions associated with CHD
©The
heat tempered platinum/iridium wire and Zig design improve stent strength,
radiopacity, and flexibility compared to the Palmaz stent
©The
C-P
Stent
design also minimizes shortening and vessel/balloon trauma while offering a
wide range of expanded diameters (8-30 mm) and lengths (11-117 mm)
©The
NuMED BIB
catheter is an innovative concept that has significantly improved operator
control during intravascular stent delivery
©Minimizes
stent flaring, migration, and shortening
©Minimizes
catheter movement during deployment
©Allows
stent repositioning before final expansion
Covering
the
C-P
Stent
is possible, but needs more investigation
Although
more data and longer follow-up are required the NuMED
C-P
Stent
and
BIB
delivery
catheter offer promise for the future
FUTURE
Miniaturize
the
C-P
Stent and
BIB
delivery system
©Use
0.011” wire - testing underway
©Reduce
Fr size of BIB
catheter
- testing underway
©Improve
“covered”
C-P Stent
©Urothane,
Silicone, ??? - testing underway
©Gain
approval for worldwide use
©FDA
- HUD submitted
©Europe
- CE Mark submitted
COMO
DETERMINAR EL TAMAÑO A USAR DEL C-P
Stent ?
El
C-P Stent
está configurado por “ZIGS”, lo cual determina el máximo rango de
expansión del diametro del stent.
Al
momento de expansión, se calcula un acortamiento del stent no mayor al 20%.
Longitudes
disponibles de 16 a 45mm.
TAMAÑOS
DISPONIBLES DEL
C-P Stent
Configuración
Expansión Máxima
#
de ZIGS del Diámetro
6
ZIGS 16mm
8
ZIGS 24mm
10
ZIGS 30mm
Todas
las configuraciones disponibles en longitudes de 16, 22, 28, 34, 39, y 45mm
(órdenes
especiales para longitud de 50mm).
TAMAÑOS
DISPONIBLES DEL BIB
Ordernar
de acuerdo a especificaciones del balón externo:
DIAMETRO:
Balones disponibles en diámetros de 8.0mm a 24.0mm
ATM:Rangos de 10.0
a 3.0
GUIA:0.035”
LARGO
DEL CATETER:
110cm
