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Auto-alignment software tool for fetal heart: multicenter international validation

Grant number: 13/01463-4
Support type:Regular Research Grants
Duration: February 01, 2014 - January 31, 2016
Field of knowledge:Health Sciences - Medicine
Principal Investigator:Edward Araujo Júnior
Grantee:Edward Araujo Júnior
Home Institution: Escola Paulista de Medicina (EPM). Universidade Federal de São Paulo (UNIFESP). Campus São Paulo. São Paulo , SP, Brazil
Assoc. researchers:Luciano Marcondes Machado Nardozza
Associated grant(s):14/07876-1 - Multi-user equipment approved in grant 13/01463-4: iU22 xMatrix (Philips), AP.EMU

Abstract

A commercially available xMatrix 6-1 ultrasound transducer is now commercially available and is Food and Drug Administration (FDA) and Agência Nacional de Vigilância Sanitária (ANVISA) approved for use during pregnancy. Early clinical experience suggests that adequate fetal heart 4D volume acquisitions from a Philips iU22 ultrasound system, using a xMatrix 6-1 probe, are more likely than what is achieved from more conventional 3D mechanical sweep volume transducers - primarily because of the faster acquisition speeds that are achievable using the newer matrix technology (e.g. 3 seconds versus 12 seconds due to fetal movement). Philips Medical Systems has recently developed a prototypic auto-alignment software program with the collaboration and input of Dr. Wesley Lee while at William Beaumont Hospital in Royal Oak, Michigan. Dr. Lee has now relocated to Baylor College of Medicine (BCM) and would now like to study the validity of this software for automatically extracting sonographic views of the sagittal ductal arch which is a key diagnostic reference plane that is used to detect congenital heart disease in fetuses. Purpose: The Auto-Alignment tool is capable of providing a clinically acceptable sagittal view of the fetal ductal arch as a reference plane for three standard cardiac views (four-chamber view, left ventricular outflow tract, 3 vessels view) in a manner that is independent of sweep orientation or gestational age. Objectives: 1. to obtain an iU22 machine to the Department of Obstetrics of São Paulo Federal University (UNIFESP), 2. to determine the validity of our prototypic software for generating diagnostically acceptable standard views of the fetal heart using 4D ultrasound volume datasets that have been acquired from normal pregnancies, 3. to acquire representative examples of abnormal fetal hearts and the percentage of abnormal cases for which the software can generate standardized heart views of acceptable diagnostic quality. Methods: It will be a multicenter study, Department of Obstetrics (UNIFESP) and Department of Obstetrics and Gynecology (BCM), for international validation of the prototype software to assess the fetal heart, being that it is presents in a Philips iU22 machine. This study has been approved by the Research Ethics at BCM and will be sent to the same Committee of UNIFESP. It will a prospective cross-sectional study with 200 normal pregnant women, 100 from each Department, divided into the following groups: 18-24, 24-28, 28-32, 32-36 weeks of pregnancy (20 per gestational age), and 40 cases of fetuses with congenital heart diseases, 20 in each Department. The collection of volumes will be conducted by an examiner in one country and analyzed offline by another one in other country, independent forms. The examiner responsible for the collection of volumes will determine the percentage of viewing patterns of all plans, as well as their quality (1 = poor, 2 = acceptable, 3 = excellent). The examiner offline will assess the ability of each volume collected in obtaining cardiac standardized plans. We will assess the adequacy of vision compare fetal (percentage with weak, acceptable and excellent) among pregnant women of different gestational ages using chi-square test (x2). We will also compare each patient in obtaining the adequacy of the patterns plans by the McNemar test. Expected results: The proof of validation, lead to the patenting of software and its commercial sale in iU22 machine from Philips company. This will provide to physicians and researchers around the world to better assessing of fetal heart, providing higher rates of detection of congenital heart disease, with improved of perinatal outcomes. The new patent will have participation of Brazilian researches, contributing to the scientific and technological development of the state of São Paulo and Brazil, besides enabling new multicenter studies. (AU)