Presentación de PowerPoint - medicinafetalbarcelona.org
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Presentación de PowerPoint - medicinafetalbarcelona.org
Assessment of fetal lung maturity by ultrasound texture analysis fetal i+D - Fetal Medicine Research Center BCNatal – Centre de Medicina Maternofetal i Neonatologia de Barcelona Hospital Clínic - Hospital Sant Joan de Déu Universitat de Barcelona Neonatal respiratory morbidity Clinical use of NRM assessment Ultrasound Texture Analysis www.medicinafetalbarcelona.org/ Neonatal respiratory morbidity Clinical use of NRM assessment Ultrasound Texture Analysis www.medicinafetalbarcelona.org/ NEONATAL RESPIRATORY MORBIDITY EUROPE AND EEUU 2-3% (200-300 K) / year ≥ 5 6 7 Neonatal respiratory morbidity Clinical use of NRM assessment Ultrasound Texture Analysis www.medicinafetalbarcelona.org/ COMPROBACIÓN Y CORTICOIDES PARA MADURACIÓN PULMONAR FETAL INDICACIÓN DE FINALIZACIÓN (o información sobre madurez pulmonar fetal) <"35.0"sem" ≥"35.0"'"<39.0!!sem! Finalización!indicada.!Condiciones!clínicas!permiten!demora!para!corticoides.! Indicación!de!finalización!no!absoluta!pero!opción!razonable!(1).! " Ha"recibido"corticoides" y"quantusFLM®"disponible" !(si!no!disponible,!administrar!corticoides!de! acuerdo!con!recomendaciones)!! N N NO"ha"recibido"corticoides:!!corticoides.! ! " Si!inducción!del!parto!y!<!37.0!sem!o!! Si!CS!electiva!y!<!39.0!sem! A!partir!del!día!siguiente!a!la!!2ª!dosis:! MPF MPF BAJO!riesgo!de! !morbilidad!respiratoria!neonatal*! Programar! finalización BAJO!riesgo!de! !morbilidad!respiratoria!neonatal*! ALTO!riesgo!de! morbilidad!respiratoria!neonatal* Según!indicación!y!EG,!considerar:! N!demorar!!3N7!días!la!finalización!y/o!! N!tanda!o!dosis!única!o!multiple!de!corticoides!(si!<!35.0sem)!y/o!! N!reevaluar!quantusFLM®!en!1!sem!o! N!si!se!requiere!finalizar!a!pesar!de!inmadurez:!informar!neonatología! ! *Morbilidad!respiratoria!neonatal!=!incluye!síndrome!de!distrés!respiratorio!y!taquipnea! transitoria!neonatal Programar! finalización (1)"Ejemplos"de"situaciones"potenciales":" NHipertensión!crónica!o!diabetes!de!difícil!control.! NBalance!hídrico!positive!con!discomfort!severo!materno.! NColestasis!muy!sintomática!sin!respuesta!a!tratamiento.! NPreeclampsia!leve!o!CIR!tardío!estadío!I!con!MAO.! NPlacenta!previa!con!sangrado!intermitente!moderado!y!multiples!ingresos.! PROTOCOLS DE MEDICINA FETAL I PERINATAL 4/4 9 36.0w, 38y, IVF Chronic HT + poorly controlled diabetes. Edema with maternal discomfort No absolute medical indication. ¿RISK NRM? BASELINE: AT 36W = 6% INDIVIDUALIZED: TEST LUNG MATURITY (*IF CORTICOIDS REDUCE 40% RISK) LOW RISK =2% HIGH RISK =36% Delivery. Risk probably higher than waiting. Wait 1w and repeat test Neonatal respiratory morbidity Clinical use of NRM assessment Ultrasound Texture Analysis www.medicinafetalbarcelona.org/ TRANSMURAL Fetal and Perinatal Medicine Research Group BIOTECH Background Is it possible to use ultrasound to test fetal lung maturity? Grannum, P.A., R.L. Berkowitz, and J.C. Hobbins, The ultrasonic changes in the maturing placenta and their relation to fetal pulmonic maturity. Am J Obstet Gynecol, 1979. Fried, A.M., et al., Echogenicity of fetal lung: relation to fetal age and maturity. AJR Am J Roentgenol, 1985 Harman, C.R., et al., The correlation of ultrasonic placental grading and fetal pulmonary maturation in five hundred sixty-three pregnancies. Am J Obstet Gynecol, 1982. Golde, S.H., M.P. Tahilramaney, and L.D. Platt, Use of ultrasound to predict fetal lung maturity in 247 consecutive elective cesarean deliveries. J Reprod Med, 1984. Zilianti, M. and S. Fernandez, Correlation of ultrasonic images of fetal intestine with gestational age and fetal maturity. Obstet Gynecol, 1983. Feingold, M., et al., Fetal lung to liver reflectivity ratio and lung maturity. J Clin Ultrasound, 1987. www.medicinafetalbarcelona.org TRANSMURAL Fetal and Perinatal Medicine Research Group BIOTECH Background Is it possible to use ultrasound to test fetal lung maturity? Quantitative ultrasound analysis Chen, D.R., et al., Diagnosis of breast tumors with sonographic texture analysis using wavelet transform and neural networks. Ultrasound Med Biol, 2002. Wan, C., et al., Evaluation of breast lesions by contrast enhanced ultrasound: Qualitative and quantitative analysis. Eur J Radiol. 2011. Hartman, P.C., et al., Variability of quantitative echographic parameters of the liver: intra- and interindividual spread, temporal- and age-related effects. Ultrasound Med Biol, 1991. Kadah, Y.M., et al., Classification algorithms for quantitative tissue characterization of diffuse liver disease from ultrasound images. IEEE Trans Med Imaging, 1996. Tekesin, I., et al., Assessment of fetal lung development by quantitative ultrasonic tissue characterization: a methodical study. Prenat Diagn, 2004. Maeda, K.S., M., Fetal lung immaturity assessment with ultrasonic tissue characterization:GLHW. 26th The Fetus as a Patient, San Diego, 16:40, April 27 2010. www.medicinafetalbarcelona.org Design : STEP 1 Describe fetal lung texture along gestation 900 pregnant women from 16.0 to 42.0 weeks Inclusion criteria: Low risk pregnant women Exclusion criteria: Fetal malformations, Multiple gestation www.medicinafetalbarcelona.org/ Design : STEP 2 Correlate fetal lung texture with the FLM-TDx II ü To perform 2D US image the same day (± 12 h) of AF collection ü Graphical User Interface (GUI) delineation ü FLM results obtained by amniocentesis: mature/immature www.medicinafetalbarcelona.org/ Design : STEP 2 Correlate fetal lung texture (AQUA) with the FLM-TDx II n 69 (range 24.6 to 40.2 w) • Mature: n= 22 • Immature: n = 47 Sensitivity of 86%, Specificity of 98%, Accuracy of 90% Performance of an automatic quantitative ultrasound analysis (AQUA) texture extractor to predict fetal lung maturity assessed by TDx-FLM in amniotic fluid. Palacio M, Cobo T, Martínez M, Rattá G, Elías N, Bonet E, Amat I, Gratacós E. Award of Research Excellence. Oral presentation www.medicinafetalbarcelona.org/ SMFM 2012, Dallas. Design : STEP 1 900 images 957 images From June 2010 to December 2010 Do not use direct grey level Do not use tissue reference Various settings admitted Not strictly influenced by the ROI acquired Analysis off-line www.medicinafetalbarcelona.org/ R Pearson correlation = 0.98 • • • • N=144 Singleton pregnancies 29.0 - 38.6 w Axial thoracic section Non Invasive Assessment of the risk of Neonatal Respiratory morbidity www.quantusFLM.com Patient & Provider Information PATIENT NAME: CLINIC NAME: Name Surname Complete Center Name PATIENT ID: REFERRING/ORDERING CLINICIAN: NHC12345678 Sabino Arana 38 1 1 08028 Barcelona, Spain CIF: B 65084675 Clinician Name Surname QUANTUSFLM ID: REPORT DATE: (dd/mm/yyyy) btech 123 01/01/2000 Test Result NEONATAL RESPIRATORY MORBIDITY Sample Information QUANTUSFLM ID: btech 123 RESULT: LOW RISK Neonatal Respiratory Morbidity (*): Theoretical risk for ## weeks of gestation: ##.# % quantusFLM risk: • • ##.# % RECOMMENDATION: (dd/mm/yyyy) GESTATIONAL AGE: ## weeks # days US ACQUISITION DATE: (dd/mm/yyyy) 01/01/2000 REQUEST DATE: (dd/mm/yyyy hh:mm) 01/01/2000 00:00 Imatge Firma 90% NEONATAL RESPIRATORY MORBIDITY RISK 80% 70% 60% 50% 40% 70% 60% 50% 40% HIGH RISK 30% 20% 10% 20% 10% 0% LOW RISK Theoretical Risk* quantusFLM Risk 100% 90% Respiratory Distress Syndrome Transient tachypnea of newborn Technical Responsible: Elisenda Bonet i Carné, MSc Graphic Test Result 100% Review results with patient AUTHORIZED SIGNER/S: 80% TEST DESCRIPTION quantusFLM™ offers an automatic assessment of neonatal respiratory morbidity risk using an ultrasound image of the lateral axial transverse section of the fetal thorax at the level of the 4 chamber section of the fetal heart. quantusFLM™ is based on quantitative ultrasound texture analysis to extract information from ultrasound images and a classifier which uses the extracted information to assess the risk. Test result depends on the delineation of the fetal lung and incorporated the gestational age. Neonatal respiratory morbidity is defined as respiratory distress syndrome or transient tachypnea of the newborn. Test has been validated in singleton pregnancies from 28.0 to 39.0 weeks of gestation. Test are neither intended nor validated for use in pregnancies with fetal structural abnormalities, chromosomal abnormalities, multiple pregnancies or maternal BMI>35. This result should not be considered as a final indication but as additional information to be considered in evaluation of the patient. 30% 0% CLINICAL DATA SPECIFICATIONS Accuracy 87% (95% CI:82 90%) Sensitivity 91% (95% CI:77 98%) Specificity 86% (95% CI:82 90%) Positive Predictive Value 47% (95% CI:35 59%) Negative Predictive Value 98% (95% CI:96 99%) REFERENCE: Quantitative ultrasound texture analysis of fetal lung to predict neonatal respiratory morbidity. UOG (2014) quantusFLM Test is intended for clinical use and should not be regarded as investigational or for research. Present result has been obtained using quantusFLM X.X. Under the previous of Law 15/1999 normative, we inform you that your data will be included in a data base owned by TransmuralBiotech, S.L. for its clinical treatment. You may exercise the rights of access, rectification, cancellation and opposition contacting us at [email protected]. (*) RDS: Respiratory symptoms (eg, grunCng, flaring, tachypnea, retracCons), O2 requirement + chest Rx + NICU admission TT: chest Rx impression + clinical diagnosis by clinician in charge. JAMA 2010 www.medicinafetalbarcelona.org/ vs Conclusions • Quantitative ultrasound fetal lung maturity analysis predicted neonatal respiratory morbidity with an accuracy comparable to current tests using amniotic fluid. • Results being validated in international multicenter trial (n>700) www.medicinafetalbarcelona.org/ COMPROBACIÓN Y CORTICOIDES PARA MADURACIÓN PULMONAR FETAL INDICACIÓN DE FINALIZACIÓN (o información sobre madurez pulmonar fetal) <"35.0"sem" ≥"35.0"'"<39.0!!sem! Finalización!indicada.!Condiciones!clínicas!permiten!demora!para!corticoides.! Indicación!de!finalización!no!absoluta!pero!opción!razonable!(1).! " Ha"recibido"corticoides" y"quantusFLM®"disponible" !(si!no!disponible,!administrar!corticoides!de! acuerdo!con!recomendaciones)!! BAJO!riesgo!de! !morbilidad!respiratoria!neonatal*! Programar! finalización N N NO"ha"recibido"corticoides:!!corticoides.! ! " Si!inducción!del!parto!y!<!37.0!sem!o!! Si!CS!electiva!y!<!39.0!sem! A!partir!del!día!siguiente!a!la!!2ª!dosis:! BAJO!riesgo!de! !morbilidad!respiratoria!neonatal*! ALTO!riesgo!de! morbilidad!respiratoria!neonatal* Según!indicación!y!EG,!considerar:! N!demorar!!3N7!días!la!finalización!y/o!! N!tanda!o!dosis!única!o!multiple!de!corticoides!(si!<!35.0sem)!y/o!! N!reevaluar!quantusFLM®!en!1!sem!o! N!si!se!requiere!finalizar!a!pesar!de!inmadurez:!informar!neonatología! ! *Morbilidad!respiratoria!neonatal!=!incluye!síndrome!de!distrés!respiratorio!y!taquipnea! transitoria!neonatal Programar! finalización (1)"Ejemplos"de"situaciones"potenciales":" NHipertensión!crónica!o!diabetes!de!difícil!control.! NBalance!hídrico!positive!con!discomfort!severo!materno.! NColestasis!muy!sintomática!sin!respuesta!a!tratamiento.! NPreeclampsia!leve!o!CIR!tardío!estadío!I!con!MAO.! NPlacenta!previa!con!sangrado!intermitente!moderado!y!multiples!ingresos.! PROTOCOLS DE MEDICINA FETAL I PERINATAL 4/4 22 36.0w, 38y, IVF Chronic HT + poorly controlled diabetes. Edema with maternal discomfort No absolute medical indication. ¿RISK NRM? BASELINE: AT 36W = 6% INDIVIDUALIZED: TEST LUNG MATURITY (*IF CORTICOIDS REDUCE 40% RISK) LOW RISK =2% HIGH RISK =36% Delivery. Risk probably higher than waiting. Wait 1w and repeat test Obtención de imágenes (ecografía) www.medicinafetalbarcelona.org/ Envío de imágenes a la app dggdf ® para análisis Informe de resultados