Ibero-American Symposium An Analysis of Endoscopy in
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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: gilabert_juaest@gva.es 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: josealejandroleon@gmail.com 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 This image cannot currently be display ed. 18 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 (PBLAC75) – NovaSure - 88.3% – Rollerball - 81.7% • Amenorrhea – NovaSure - 40.9% – Rollerball - 35.4% • Decrease in Bleeding to Normal Levels (PBLAC100) – NovaSure - 90.9% – Rollerball - 87.8% 19 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 20 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 21 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 22 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. 23
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