Ibero-American Symposium An Analysis of Endoscopy in

Ibero-American Symposium An Analysis of Endoscopy in

Ibero-American Symposium
An Analysis of Endoscopy in Ibero-America:
Progress, Methods and Critical Analysis
of Its Evolution (Didactic)
PROGRAM CHAIR
Hector Hugo Bustos, MD
Francisco Carmona, MD
José Alejandro León, MD
Juan Gilabert Estelles, MD Jose Gerardo Garza Leal, MD
Jose M. Mojarra, MD
Sponsored by
AAGL
Advancing Minimally Invasive Gynecology Worldwide
Professional Education Information Target Audience This educational activity is developed to meet the needs of residents, fellows and new minimally invasive specialists in the field of gynecology. Table of Contents Course Description ........................................................................................................................................ 1 Treatment of Peritoneal Endometriosis including Pain Management J.M. Mojarra .................................................................................................................................................. 2 Methods for Treatment of Severe Endometriosis J.G. Estelles .................................................................................................................................................... 5 Diagnostic Methods in Deep Infiltrating Endometriosis F. Carmona ................................................................................................................................................... 9 Endometrial Hyperplasia with Atypia: Is the Combined Therapy an Alternative? J.A. Leόn ...................................................................................................................................................... 13 Research opportunities in Latin America of gynecological endoscopy J.G.G. Leal ....................................................................................................................................... 16 Cultural and Linguistics Competency ......................................................................................................... 23 Ibero-American Symposium
An Analysis of Endoscopy in Ibero-America:
Progress, Methods and Critical Analysis of Its Evolution
Hector Hugo Bustos, Chair (Mexico)
Faculty: Francisco Carmona (Spain), Juan Gilabert Estelles (Spain), Jose Gerardo Garza Leal (Mexico),
José Alejandro León (Venezuela), Jose M. Mojarra (Mexico)
This course provides an opportunity to review and discuss techniques that are being carried out
routinely in Ibero-America, including: laparoscopic treatment of superficial peritoneal endometriosis,
treating and managing pain, treatment of deep endometriosis with extensive retroperitoneal dissection,
and a discussion on how the laparoscopic treatment of some pathologies has been modified by methods
such as nuclear magnetic resonance.
We will also analyze the probable causes and conservative treatment for patients diagnosed with
atypical endometrial hyperplasia.
Finally, we will present an analysis of schools in Ibero-America that offer instruction on endoscopy, and
the impact they have had on improving gynecological surgery in the region.
Learning Objectives: At the conclusion of this course, the clinician will be able to: 1) Discuss the most
common techniques in peritoneal endometriosis treatment, including endoscopic techniques for
managing pain; 2) discuss laparoscopic treatment of deep endometriosis, including extensive
retroperitoneal dissection; 3) evaluate the usefulness of magnetic resonance imaging in gynecological
pathology from a cost-efficient perspective; 4) assess the impact of schools that teach gynecological
endoscopy and minimally invasive surgery in the Ibero-American region; and 5) discuss probable causes
and conservative treatment for patients diagnosed with atypical endometrial hyperplasia.
Course Outline
1:10
Welcome, Introductions and Course Overview
1:15
Treatment of Peritoneal Endometriosis including Pain Management
1:25
Methods for Treatment of Severe Endometriosis
J.G. Estelles
1:35
Diagnostic Methods in Deep Infiltrating Endometriosis
F. Carmona
1:45
Endometrial Hyperplasia with Atypia: Is the Combined Therapy an Alternative?
1:55
Research opportunities in Latin America of gynecological endoscopy
J.G.G. Leal
2:10
Questions & Answers
All Faculty
2:15
Adjourn
1
H.H. Bustos
J.M. Mojarra
J.A. León
Objetivos
Treatment of Peritoneal Endometriosis including Pain Management
• Mostrar una técnica de resección de
endometriosis con energía monopolar
• Mostrar una ténica simplicada para la
José M. Mojarra-Estrada
Federación Mexicana de Endoscopia Ginecológica
neurectomía presacra
• Revisión de los estudios publicados
Manejo laparoscópico de la endometriosis:
Revisión de la mejor evidencia
Yeung, Shwayder, Pasic
JMIG 2009 (16):269-281
•
•
•
•
Dolor y endometriosis
Busacca M. JMIG 2006(13);573-75
La endometriosis es útil para el tratamiento del dolor pelvico. Sutton
63 p ablación VAS (Qx 63vs Dx 33%)
• Los objetivos de tratamiento
laparoscópico conservador de la
endometriosis son:
No hay diferencia entre la ablación y excisión de la endometriosis.
Wright no diferencia entre la puntuación de VAS
No es útil la ablación laparoscópica de los ligamentos uterosacros
(LUNA), 3 estudios comparando cirugía de endometriosis con o sin
LUNA, el de mayor seguimiento a 3 años (Vercellini), no mostro
beneficio adicional.
• Erradicar las lesiones endometriósicas
• Eliminar los síntomas
• Limitar la recurrencia
La neurectomía presacra (NPS) es útil para el dolor central en todos
los estadios de la endometriosis. Zullo aleatorizó 141 pacientes a
cirugia de endometriosis A/E con o sin NPS, la mejoria del dolor fue
mayor en grupo combinado 87.3% contra el grupo sin la NPS.
Estudio multicentrico de pacientes
sometidas e excisión de
endometriosis
Principios básicos para la excisión de
la endometriois peritoneal
Sprague ML, Liu CY
Yeung P y cols.
Abstract/JMIG 2012.19:S71-S122
Abstract/JMIG 2012.19:S151-S178S175
•
La excisión de laAbs
endometriosis
•
peritoneal y profunda puede ser un
reto
•
• Se propone un abordaje sistemático
•
para llevarla a cabo
•
• TIME: tracción, incisión, mobilización y
excisión.
•
• Facilmente reproducible
2
Servir de estudio pilóto para comparar la excisión contra la ablación
de la endometriosis
Estudio multicentrico, 100 pacientes, 18-55 años, con dolor pélvico y
sospecha de endometriosis
Calidad de vida, dolor pélvico, dismenorrea, dispareunia, síntomas
urinarios e intestinales
Seguimiento de 8.5 meses, la excisión de la endometriosis mostro
una mejoria significativa en todos los aspectos, excepto en las
molestias intestinales
Se observó mejoria significativa en la calidad de vida en el 84% de
las pacientes.
Estudio aleatorizado de excisión vs
ablacion endometriosis leve
Excisión cortante laparoscópica de endometriosis:
análisis de tablas de vida de reoperación,
recurrencia y persistencia de la enfermedad.
Wright y cols.
Fertil Steril 2005;83:1830-6
Redwine DB. Fertil Steril 1991;56:628-34
•
•
•
•
•
•
•
Objetivo: Determinar el resultado a largo plazo de la excisión
laparoscópica de la endometriosis
Diseño: Estudio longitudinal, 359 pacientes, usando cuestionarios de
seguimiento y evaluaci´pn de reoperaciones, centro privado, 19801990.
•
Intervenciones: Excisión completa de la endometriosis incluyendo la
profunda utilizando pinzas y tijeras de 3 mm, no se utilizó tratamiento
medico coadyuvante.
•
Resultados: La tasa máxima de recurrencia o de persistencia de la
enfermedad fue del 19% al 5to año postoperatorio.
•
Healey y cols.
Fertil Steril 2010:94:2536-40
•
•
•
•
•
12 pacientes ablación punta de la tijera 3 mm 50wCoag
No hubo diferencia estadísticamente significativa entre los dos
grupos, ambos grupos mejoraron significativamente
No hubo morbilidad adicional con la excisión, la cual permitió la
confirmación histológica
La ablación tiene la desventaja de dejar areas extensas de necrosis
generando mayor inflamación y riesgo de formación de adherencias
La excisión deja el tejido conectivo sano el cual es recubierto por
peritoneo rápidamente
Excisión laparoscópica de endometriosis con
tijeras de 3 mm: comparación de los tiempos
operatorios entre la excisión cortante y la electroexcisión.
Tratamiento quirúrgico de la endometriosis:
estudio aleatorizado, prospectivo, doble ciego
comparando excisión y ablación
•
12 pacientes grupo excisión tijeras 3 mm 90wCorteP y 30 wCoag
Redwine DB. J Am Assoc Gynecol Laparosc. 1993;1(1):24-30
178 pacientes fueron aleatorizadas, 89 al grupo de ablación y 85 al
grupo de excisión.
•
No existieron diferencias en las características demográficas y
puntuaciones de dolor VAS
•
La puntuación promedio de la AFS para el grupo de ablación fue de
10 (r2-53) y de 7 para el grupo de excisión (r1-33)
•
Endometriosis profunda en 53% de las pacientes del grupo de
excisión y 22% en el grupo de ablación.
•
Del grupo de excisión se confirmó endometriosis en el 87% (46/53)
Objetivo: Determinar si la excisión electroquirúrgica de la
endometriosis es más rápida que la excisión cortante.
Diseño: Estudio retrospectivo comparando el tiempo entre los dos
procedimientos.
Resultados: El tiempo operatorio promedio de la electro-excisión fue
de 26 a 49% mas rápido que la excisión cortante.
Conclusión: La reducción en el tiempo operatorio logrado con la
electro-excisión monopolar se debe a una acción de corte más rápida
con la coagulación simultánea de los vasos sangrantes.
No hubo diferencia en la reducción de la puntuación VAS en los dos
grupos
Video excisión de endometriosis
Video neurectomía presacra
• 1 minuto
• 1 minuto
3
p
p
del dolor pélvico asociado a
endometriois
Neurectomía presacra para el manejo
del dolor pélvico asociado a
endometriois
j
Palomba, Zullo, Zupi, Russo, Tolino, Marconi, Mattei
JMIG 2006 (13):377-385
Palomba, Zullo, Zupi, Russo, Tolino, Marconi, Mattei
JMIG 2006 (13):377-385
• 10% de la consulta ginecológica
• 20% de las indicaciones de
•
laparoscopia
• 20% de los casos de dolor pélvico
•
asociado a endometriosis no responden
al tratamiento médico
•
• Endometriosis presente del 37 al 74%
de los casos de dolor pélvico crónico
(DPC)
• El tratamiento
laparoscópico
Conclusiones
conservador de la endometriosis es
efectivo
• No hay diferencia entre la excisión y la
ablación en relación a la mejoria del
dolor pélvico.
• La excisión aparentemente es mejor
para el tratamiento de la endometriosis
profunda.
• La neurectomia presacra es útil para el
manejo del dolor pélvico central, su
efecto es duradero.
4
Los resultados de mejoria de la dismenorrea central varian del 37 al
89%(Ingersoll, Frier, Meigs, Counseller, Tucker y Black)
Seguimiento de 24 a 72 meses (Nezhat) se observo mejoria en el
dolor pélvico, dismenorrea y dispareunia en el 70%, 60% y 50%
respectivamente.
Zullo confirmo en un estudio controlado aleatorizado la mejoria del
dolor en pacientes sometidas cirugia de endometriosis y NPS
seguidas por 24 meses
www.egesvalencia.com
www.egesvalencia.com
DISCLOSURE
Methods for Treatment of Severe Endometriosis
Gilabert-Estellés J
Prof. University of Valencia (Spain)
Director European Gynecology Endoscopy School
Chief of Department. Hospital General Universitario.
email: [email protected]
I do not have relevant financial relationships to disclose.
websites: www.egesvalencia.com
www.gilabertginecologos.es
www. chguv.san.gva.es
ENDOMETRIOSIS
TYPES OF
ENDOMETRIOSIS
www.egesvalencia.com
Peritoneal
Ovarian
Rectovaginal
OBJECTIVE
To develop a systematic surgical strategy for the treatment of Deep Infiltrating Endometriosis
EXPOSURE
DEEP INFILTRATING ENDOMETRIOSIS
Endometriotic lesion (glands + stroma) that infiltrate > 5 mm in subperitoneal tissue
Patient position
Other
Uterine manipulator
5
Rectal probe
EXPOSURE
PERITONEAL DIE
Laparoscopic surgery for pelvic pain associated with endometriosis (Cochrane Review)
Jacobson TZ et al. Cochrane Database of Systematic Reviews 2010, 4.: CD0013982002
Canadian study (Marcoux 97)Evaluate
evolutive pregnancies
Higher statistical power
Italian study (Parazzini 99)
Active/inactive lesions not referred
No paghological confirmation
Postoperative GnRHa
High proportion stage II
14 Centers
7,7 surgeries to obtain one pregnancy
DIE: SURGICAL STRATEGY
Opening pararectal fosa
Ureteral identification
Pregnancy rates observed after excisional surgery of
rectovaginal endometriosis (LPS&LPT)
Infertile patients with DIE should be informed that
surgery will improve their symptoms but will not improve
significantly pregnancy rates
Complications should be discussed before surgery
Reproductive outcomes will improve if ovarian or
Major complication 3-10%
peritoneal endometriosis is also present
Major intra- and post-operative complications of
radical surgery for rectovaginal endometriosis
Pain reduction in 70-80%
At one year: 50% require certain analgesia
6
Complications, pregnancy and recurrence in a prospective series of 500 patients operated on by the shaving technique for deep rectovaginal endometriotic nodules
Rectum and rectosigmoid junction
(65.7%)
(17.4%)
Minelli L et al.Sigmoid
Fertil Sterilcolon
2010;94:1218–22.
500 pacientes con nódulo rectovaginal
Caecum and ileocaecal junction (4.1%),
Global
recurrence rate
(3,6%
in pregnant vs 15%
Retrospective
13638%
stage
IV patients
GROUP A (n=60)
Appendix
(6.4%)
in non
pregnant)
Intraoperative
complications 2.0%
BOWEL
RESECTION
Small
bowel (4.7%)
Risk
x3 if bowel
resection
Higher
morbidity
if bowel
resection
Omentum
(1.7%)
B (n=40)
ReoperationGROUP
rate 4.1%in
the first week if
SUBOPTIMAL THERAPY
bowel resection
Chapron et al., 2006
361
GROUP C (n=55)
1417
DIE
696WITHOUT BOWEL INVOLVEMENT
Recurrence
rate
Multifocal and
multicentric involvement was
Group
A (7%),
(15%)
y C(0%)
(p<0,05)
observed
in 62Band
38%
of surgical
en bloc
specimens, respectively (Kavallaris, 2003)
Complication rate in bowel resection:
Fistula (3.2%), ureteral lesion (1.6%), bladder
lesion (1.6%), bowel occlusion (1.6%),
transfusion(12.8%)
URETERAL ENDOMETRIOSIS
URETEROLYSIS
15
TERMINOTERMINAL
ANASTOMOSIS
URETERAL REIMPLANTATION
56 moderate-severe ureteral hydronefrosis c
(follow up 21 months)
Complication rate:
35,3 % in TT anastomosis (6/17)
11.7% in ureterolysis ( 27/35)
7
Ureteral involvement in nodules over
3cm
Extrinsec involvement
(Ureterolysis)
BLADDER ENDOMETRIOSIS
MULTIDISCIPLINAR APPROACH IN
ENDOMETRIOSIS
Gynecologist
General Surgeon
Coloproctologist
Urologist
Diet
recommendations
General Health
%
Psychologists Counsellors
Surgeons
General Doctor
Woman And Gynaecologist
Decision making team
TAKE HOME MESSAGES
• Knowledge about different types of endometriosis is essential for the management of
patients with infertility and painful symptoms
• Infertile patients with DIE should be informed that surgery will improve their
symptoms but will not improve significantly pregnancy rates
• Information should be provided before surgery concerning the risk of complications and
the possibilities of recurrence of symptoms according to the experience of the group
• Excision of DIE needs a surgical strategy in order to prevent complications
•
More studies with more accurate information are needed in order to define the exact
role of DIE in infertility
8
Relatives
Friends
Partner
Sexologist
Love
Complementary therapies
Patient support groups
Online
Meetings
Literature
Telephone
Fertility
preservation
IUI
IVF
ICSI
Reproductive program
Pain management Unit
Acupunture
Exercise
Massage
Homeopathy
Reflexology
Herbalists
Diagnostic Methods in Deep
Infiltrating Endometriosis
No financial interest to declare
FRANCISCO CARMONA
HOSPITAL CLINIC
BARCELONA (ESPAÑA)
DEFINITION. CLASSIFICATION
- Chronic, “benign”, sometimes invasive, uncertain evolution
- High prevalence among fertile women
(10-20% general population)
- Diagnostic delay (up-to 12 years):
- High economic burden
- Serious health problems
To analyze diagnostic methods
currently
available
for
Deep
Infiltrating Endometriosis
- Ectopic endometrium in any localization: 4 types:
- PERIRONEAL ENDOMETRIOSIS.
- OVARIAN ENDOMETRIOSIS.
- DEEP INFILTRATING ENDOMETRIOSIS.
- ADENOMIOSIS.
-Often different Types and Localizations coexist in the same patient.
Current gold standard for endometriosis staging is still surgery
CORRECT DIAGNOSIS
Surgery limitations for diagnosis of endometriosis
- Permits:
• No evaluation of degree of infiltration in DIE
• Under diagnosis of DIE nodules
• Complications: 2.4/1000 (entry)
• Economic burden
• >20% normal findings
• Incomplete surgery
recurrence
1.- Prognosis
2.- Follow-up
3.- Information
4.- Treatment (surgery /medical treatment /combined).
5.- Correct surgical planning
Royal Collegue of Obstetricians and Gynaecologists. The investigation and management of
endometriosis. Guideline 24 (2006). RCOG Green Top Guideline, London , UK.
Chapron C et al. (1998). Surgical complications of diagnostic and operative gynaecological
laparoscopy: a series of 29,966 cases. Hum Reprod.
Banerjee SK et al. (2008). Endometriomas as a marker of disease severity. J Minim Invasive
Gynecol.
Vignali M et al. (2005). Surgical treatment of deep endometriosis and risk of recurrence. J
Minim Invasive Gynecol.
9
PRESURGICAL STAGING
ADVANTAGES OF PRESURGICAL STAGING:
•
•
•
•
PRESURGICAL STAGING
Non invasive
Specialized team available
Informed consent
No incomplete surgeries:↓ recurrences
Medical case history
Clinical examination
Image
Transvaginal ultrasound
MRI
TRANSVAGINAL
ULTRASOUND
• Pelvic pain symptoms: dismenorrea, dysquezia, dyspareunia, dysuria
• Visual analogic scale (VAS)
QUESTIONNARIES • Intensity
• Quality of Life
• Worsening with menstruation
MAGNETIC RESONANCE IMAGING
OTHERS
ENDOMETRIOMA: Typical ultrasound image
First test
• Simple, not expensive
• Allow diagnosis of ovarian and DIE and adenomyosis
• Short learning curve
10
Others: cistoscopy, pielography, renography, ecoendoscopy…
DIE IMAGES
RECTOVAGINAL SEPTUM
• Low echoic images, regular or irregular limits, with
echoes starting in the middle of the image (“indian
cloth”).
• Lineal thickening; irregular areas; regular nodule.
• Anterior or posterior cul‐de‐sac, intestine (rectum, sigma, appendice, small bobwel), retrocervical area(USL, posterior vaginal fornix), rectovaginal septum
• Painful with probe pressure?
• Tenderness guided: vaginal exploration
with jelly excess over probe
• Sonovaginography: Saline in vagina
INTESTINAL INVOLVEMENT
ADHESIONS
•Severity of infiltration (rectal probe):
• Kissing ovaries: both ovaries stucked together and at the posterior uterine wall
• Sliding sign: pressing anterior abdominal wall looking at the movement of the bowel over the uterus
• Obliteration of the posterior cul‐de‐sac: occlusion of the space beetwen both USL
•serose (hyperechoic)
•muscularis (hypoechoic)
•submucose (hypoechoic)
•mucose (hyperechoic)
TV Ultrasound:
MRI:
Easiest
Whole abdominal cavity
Cheaper
IV urography: Ureteral involvement
Bladder ultrasound: Intravesical
nodules
Adenomyosis
Endometrioma (shading)
Isotopic Renography: When renal function is impaired
Comfortable
Nodule over rectosigma junction
More familial to the gynecologist
Dinamic exploration: Adhesions, Pain
Better vision DIE when myoma
Cistoscopy: Intravesical nodules
Indicated when ureteral or appendicular
endometriosis
11
CONCLUSIONS
Rectal Endoscopia Ultrasound: Rectal involvement (up to the rectosigma
junction)
DIE must be diagnosed using non invasive methods. Incomplete surgery
must be avoided
Barium Enema : Bowel Involvement
Transvaginal ultrasound and MRI are the mainstay in the preoperative
staging of endometriosis
CT scan: Toracic lessions
12
Dr. José Alejandro León P.
Email: [email protected]
Armstrong et al. Diagnosis and Management of Endometrial Hyperplasia. J min inv. May 2012
Asintomáticas
Obesidad, S. metabólico, Diabetes
SA 5%
A 2%
Factores de riesgos
Hiperplasia
CA de endometrio
Sintomáticas
10 – 20%
PCOS 20% PCOS, anovulación, S. de Lynch
Estrógenos, SERMs
HUA 10%
Armstrong et al. Diagnosis and Management of Endometrial Hyperplasia. J min inv. May 2012
Armstrong et al. Diagnosis and Management of Endometrial Hyperplasia. J min inv. May 2012
13
Manejo
BI
AII
Quirúrgico
AII
Histerectomía (AI)
BI
•Histerectomia AI
•Histerectomia supracervical
es inaceptable AII
Ablación endometrial (DI)
Progestagénos: (BI)
Oral
Parenteral
Local
Trimble et al Management of Endometrial Precancers. Obstetrics & Gynecology. vol. 120, no. 5, november 2012 Manejo quirúrgico
Farmacológico
Trimble et al Management of Endometrial Precancers. Obstetrics & Gynecology. vol. 120, no. 5, november 2012 Manejo Farmacológico y mínimo invasivo
•Progestageno oral o sistémico BI
•Ablación endometrial DII
•Seguimiento por muestreo AII
14
Biomarcadores:
• Reducción S6 ‐ Aumento Ki67
• Metformina adyuvante
Histeroscopia
No Coincidencia
N
%
Coincidencia
N
%
Total
N
Normal
2
15
11
85
13
Ca de
endometrio
0
0
2
100
2
Pólipo
endometrial
0
0
Hiperplasia
endometrial
6
Mioma
3
Endometrio
atrófico
2
16
100
16
14,3
15
85,7
21
25
15
75
18
12,3
7
77,7
9
6 Hiperplasia con atipias
DIU LNG PROGESTAGENO ORAL
Muestra
(meses)
21 años
Resección + progestágenos
0
0
2
100
2
Total
10
16,5
43
89,05
81
Persistencia
Progresión
Regresión
Persistencia
Progresión
‐‐
3
22 (72%)
9 (28%)
‐‐
13 (56%)
10 (44%)
6
29 (82%)
3 (8%)
‐‐
17 (83%)
4 (17%)
‐‐
9
30 (96%)
1 (4%)
‐‐
19 (92%)
2 (8%)
‐‐
1 (4%)
‐‐
20 (95%)
1 (5%)
‐‐
12
Sinequias
Regresión
5 años Dr. León José A.
León J. y col. Hiperplasia endometrial con atipias: manejo conservador. Maternidad Santa Ana. Caracas Venezuela. 2012
15
Disclosure Relationship
– Principal Investigator and Scientific Advisor
Board Gynesonic Inc.
– Principal Investigator Minerva Inc.
– Principal Investigator IOGYN Inc.
– Principal Investigator AGEA Inc.
– Principal Investigator Thermablate Inc.
Research opportunities in Latin
America of gynecological
endoscopy
Dr. Prof.José Gerardo Garza Leal
Unidad de Endoscopia Ginecológica
Hospital Universitario, UANL
Mercado en Dispositivos Médicos
para las Mujeres
Expectativas mas largas de Vida
• 52% de la Población son mujeres
• 79.5 años mujeres
• 2/3 de los gastos en Servicios de salud
• 74.1 años hombres
• 500 Billones de dólares cada año
• 61% de las Consultas Médicas
• ¾ en asilos mujeres
• 59% de las recetas Médicas
• 2 de cada 3 que reciben cuidados especiales
MedTech Insight
Mujeres
•
•
•
•
•
•
16
Embarazo
Infertilidad
Sangrado uterino anormal
Incontinencia urinaria de esfuerzos
Anticoncepción
Menopausia
Problemas relacionados con el
embarazo
1999
• Daño al piso pelvico
• IUE
• Cx por ginecólogos
• 90 millones de mujeres entre 15 a 64 años:
120 millones visitas al doctor
• 70 mill: condiciones ginecológicas
• 2010: mas de 132 millones
– 84 mill al ginecólogo
Osteoporosis: 80% son mujeres
2000
• Mujeres 105 mill de consultas medicas por
prevención
Mercado
IUE
• Hombres, 50 millones de consultas
Cintos
• 80% son mujeres (AAGL)
Población con
dispositivo
Mercado
actual (mill)
Población
potencial
Mercado
potencial
8-13 mill
Inyecciones
de Colágeo
• Mayor numero de residentes en ginecologia
85000
30
500,000
$150 mill
$429 mill
130000
150
375000
SUA
2.5 mll
240,000
180
775,000
$700 mill
Miomas
6 mill
152,500
4
1 mill
$500,000 mill
Esterilización
transcervical
700-800,000
8000
8
210,000
200 mill
Incontinencia Urinaria
•
•
•
•
•
Población
IUE
13 mill de mujeres en USA: IUE
1 mill de casos nuevos por año
¿25 mill?
15 billones en salud relacionada a IUE
2 billones de pañales y toallas sanitarias
•
•
•
•
•
Agency of Health core Policy and research (USA)
17
Mujeres 30 a 60 años
2 veces mas que los hombres
30% de las mujeres de 15 a 64 años
50% mujeres en Asilos
Es uno de los factores mas importantes
para llevar mujeres al asilo
Mercado potencial para procedimiento mínimo invasivos
para la IUE
Sangrado Uterino Anormal
•
•
•
•
•
•
1 de cada 5 mujeres de 35 a 50%
8 mill de mujeres en USA
20 mill en el mundo
1/3 de visitas al ginecólogo
2.5 millones de consultas al año
2/3 anemia
– Dispositivos Ablación endometrial
Ablación Endometrial
• 250,000/ año (90%) con dispositivos
automáticos
– 200 mill de gastos
• 650,000 histerectomías
– 35% sangrado uterino normal
– 225,000 casos
– 500,000 pacientes
• 500 millones de dolares
Ventajas
Desventajas
Eliminación de las habilidades
para histeroscopia
Mas caso, mayor gasto capital,
suministros caros
Tiempos de procedimientos mas
rápidos
No visualización en tiempo real
(mayoría de los dispositivos)
Poca o nula curva de aprendizaje
Inhabilidad de tratar a pacientes
con patología anormal
Regreso a sus actividades de un
dia contra 2-3 días para ablación
tradicional
Se carece de datos de
seguimiento a largo plazo
CAVATERM
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Resultados
RESULTADOS DE H&E ANALISIS
HISTOLOGICO DE LA ZONA DAÑADA
35
30
 Daño Uniforme
25
20
Percent
Thermachoice
Cavaterm
Vesta
15
10
 El canal
endocervical sin daño.
5
0
1 2 3 4 5 6 7 8 9 10 11
Depth of Damage
North American Clinical
Investigators & Sites
Sistema NovaSure

Dispositivo de
Ablación
Jay Cooper, M.D. - Phoenix, AZ, USA
Richard Gimpelson, M.D. - St. Louis, MO, USA
Donald Galen, M.D. - San Ramon, CA, USA
James Liu, M.D. - Cincinnati, OH, USA
Philippe Laberge, M.D. - Quebec, Canada
Nicholas Leyland, M.D. - Toronto, Canada
Josef Scott, M.D. - Edmonton, Canada
Paul Martyn, M.D. - Calgary, Canada
Jose Garza-Leal, M.D. - Monterrey, Mexico
Controlador de radio
frecuencia
Study Results
• Study Success (PBLAC75)
– NovaSure - 88.3%
– Rollerball - 81.7%
• Amenorrhea
– NovaSure - 40.9%
– Rollerball - 35.4%
• Decrease in Bleeding to Normal Levels
(PBLAC100)
– NovaSure - 90.9%
– Rollerball - 87.8%
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Miomas Uterinos
History of Occlusive Treatment
for Uterine Fibroids
• 30-40% de las mujeres
• 10 millones de mujeres USA 25 a 45 años
• 5.5 a 6 mill de mujeres consultan en USA
para tx de miomas
• 1.2 billones en costos de salud
• Sintomáticos 10 al 30%
• Uterine Artery Embolization (UAE)
• First described as a treatment for uterine
fibroid treatment by Ravina in 1995
– 30% de los casos de sangrado uterino anormal
Good News / Bad News
Is there a Gynecologic analog?
UAE Outcomes
The good news:
Treatment of intractable
menorrhagia by bilateral
uterine vessel interruption
Uterine Artery Embolization works –
Bleeding Sx
>89%
Bulk Sx
>91%
William Bateman, MD
1964
The bad news:
Radiologists do it, Gynecologists don’t
Uterine arteries before clamp
Treatment Case
Temporary Occlusion System
Handheld Doppler
Transceiver
Rt UA
Occlusion
Device
© 2003 Vascular Control Systems
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Lt UA
Treatment Case
Treatment Case
Uterine arteries at 6 hours
Uterine arteries after clamp
Rt UA
Occluded
Rt UA
Occluded
Lt UA
Occluded
Lt UA
Occluded
Clamp
Clamp
Treatment Case
Treatment Case
Pre-Clamp
6 Hrs Post-Clamp
(Edema in Fibroids)
Pre-Clamp
6 Hrs Post-Clamp (Clot in
Fibroids)
T1 Non-Contrast MR Images
(white = clot and hemorrhage)
T2 Non-Contrast MR Images
(white = fluid)
Esterilización Transcervical
CDC
Treatment Case
Fibroid Volume Change
Uterine
Volume
Reduction
Upper
Fibroid
Reduction
Lower
Fibroid
Reduction
PreTreatment
Volume
638cc
127cc
93cc
1 Month
Shrinkage
13%
18%
39%
5 Month
Shrinkage
55%
55%
60%
• 64% de 60 mill de mujeres fértiles USA usan
un métodos de planificación familiar
• 44% de las mujeres cambió de método en el
primer año
Family Planning Prespectives
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Esterilización Transcervical
CDC
Transcervical Sterilization
ADIANA
Monterrey, MX
• 21 mill de mujeres USA usan un método de
planificación familiar no permanente
– 6.5 billones en USA
DR JOSE GERARDO GARZA
LEAL
HOSPITAL UNIVERSITARIO
MONTERREY N.L. MEXICO
– 400 billones en el Mundo
• 7.5 mill de mujeres al menos 2 hijos: SPC
Adiana Transcervical Sterilization
System
Adiana Delivery Catheter
Adiana Delivery Catheter
– Deliver RF Energy
– Deliver Biomaterial Matrix
• Adiana Radio Frequency
generator
Interim Results
•
Average procedure time
Range
12+8 minutes
4:41 to 41:32 minutes
•
Anesthesia use
– Local
48.8%
– Local +IV sedation (ie, fentanyl/opiates)
•
Follow Up
– Patients Relying on Device
– Pregnancies in wearing period
1
• Re-treatment of wrong tube- open tube undetected
– Wearing (as of March 29, 2005)
3,923 women-months
51.2%
371
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CULTURAL AND LINGUISTIC COMPETENCY
Governor Arnold Schwarzenegger signed into law AB 1195 (eff. 7/1/06) requiring local CME providers, such as
the AAGL, to assist in enhancing the cultural and linguistic competency of California’s physicians
(researchers and doctors without patient contact are exempt). This mandate follows the federal Civil Rights
Act of 1964, Executive Order 13166 (2000) and the Dymally-Alatorre Bilingual Services Act (1973), all of which
recognize, as confirmed by the US Census Bureau, that substantial numbers of patients possess limited English
proficiency (LEP).
US Population
Language Spoken at Home
California
Language Spoken at Home
Spanish
English
Spanish
Indo-Euro
Asian
Other
Indo-Euro
English
Asian
Other
19.7% of the US Population speaks a
language other than English at home
In California, this number is 42.5%
California Business & Professions Code §2190.1(c)(3) requires a review and explanation of the laws
identified above so as to fulfill AAGL’s obligations pursuant to California law. Additional guidance is provided
by the Institute for Medical Quality at http://www.imq.org
Title VI of the Civil Rights Act of 1964 prohibits recipients of federal financial assistance from
discriminating against or otherwise excluding individuals on the basis of race, color, or national origin in any of
their activities. In 1974, the US Supreme Court recognized LEP individuals as potential victims of national
origin discrimination. In all situations, federal agencies are required to assess the number or proportion of LEP
individuals in the eligible service population, the frequency with which they come into contact with the
program, the importance of the services, and the resources available to the recipient, including the mix of oral
and written language services. Additional details may be found in the Department of Justice Policy Guidance
Document: Enforcement of Title VI of the Civil Rights Act of 1964 http://www.usdoj.gov/crt/cor/pubs.htm.
Executive Order 13166,”Improving Access to Services for Persons with Limited English
Proficiency”, signed by the President on August 11, 2000 http://www.usdoj.gov/crt/cor/13166.htm was the
genesis of the Guidance Document mentioned above. The Executive Order requires all federal agencies,
including those which provide federal financial assistance, to examine the services they provide, identify any
need for services to LEP individuals, and develop and implement a system to provide those services so LEP
persons can have meaningful access.
Dymally-Alatorre Bilingual Services Act (California Government Code §7290 et seq.) requires every
California state agency which either provides information to, or has contact with, the public to provide bilingual
interpreters as well as translated materials explaining those services whenever the local agency serves LEP
members of a group whose numbers exceed 5% of the general population.
~
If you add staff to assist with LEP patients, confirm their translation skills, not just their language skills.
A 2007 Northern California study from Sutter Health confirmed that being bilingual does not guarantee
competence as a medical interpreter. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538.
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