Original Title: Avis: Pertinence du dépistage néonatal des cardiopathies congénitales graves par saturométrie (oxymétrie de pouls)

Authors' objectives: The identification, treatment and clinical outcomes of patients with critical congenital heart disease have improved considerably in the past few decades. Prenatal diagnosis and neonatal screening are two early detection strategies that permit management planning involving the family and healthcare personnel. Despite the use of second-trimester ultrasound for prenatal diagnosis and of the physical examination as detection techniques, a varying proportion of newborns with critical congenital heart disease are not identified before discharge from the hospital or birthing centre. These newborns will then be urgently admitted with an acute condition and often in a state of heart failure, with an increased risk of neurological impairment. Severe neurological impairment reportedly occurs in 5 to 10% of critical congenital heart disease patients, with milder neurological problems occurring in a further 25%, mainly in those with a late diagnosis. The Ministère de la Santé et des Services sociaux (MSSS) asked the Institut national d’excellence en santé et en services sociaux (INESSS) to assess the relevance of neonatal screening for critical congenital heart disease using the pulse oximetry test.

Authors' results and conclusions: RESULTS: The integration of the entirety of the scientific, contextual and experiential data permits the following findings to be stated: • Critical congenital heart disease can result in organ damage and life-threatening complications; • Critical congenital heart disease requires medical attention at diagnosis, surgical or catheter-based intervention as soon as possible during the first month of life, and lifelong cardiology follow-up; • The prognosis varies according to the critical cardiopathy present, but neurodevelopmental impairment is the most important comorbidity and is, in part, associated with late diagnosis; • Some newborns with critical congenital heart disease would not be identified before discharge from the hospital or birthing centre, despite the use of second-trimester ultrasound and the physical examination as detection techniques; • Adding pulse oximetry testing to prenatal ultrasound and the physical examination could potentially improve the early detection of certain types of critical congenital heart disease and identify newborns with other severe hypoxemic conditions; • Despite indirect evidence from one study, it is difficult to conclude that pulse oximetry is effective in reducing mortality in infants with critical congenital heart disease, but experts appear to be unanimous about its potential for reducing morbidity through prompt postnatal management of cases of critical congenital heart disease and of any other severe hypoxemic condition; • Pulse oximetry screening for critical congenital heart disease generally seems be considered acceptable by parents, the general public and medical personnel, and by the various health professionals involved; • According to the economic literature, the systematic implementation of pulse oximetry screening, compared to current practice, would not engender an inordinate incremental cost for society; • No major changes would have to be made to the organization of care and services for managing and following pulse oximetry-positive cases in Québec, because the facilities that offer mother-child services have professional teams on site to assess the condition of the newborn, and the continuum of care for referral services to pediatric cardiology is well established; • A balance between identifying newborns with non-stabilized transient circulation and the risk of infants becoming symptomatic before the pulse oximetry test is performed should be considered when deciding on the optimal moment to perform the test; • In the experts’ opinion, there is clinical benefit associated with identifying non-cardiac hypoxemic conditions using the pulse oximetry test.

Authors' recommendations: INESSS recommends that the practice of pulse oximetry as basic care for newborns be expanded and standardized in all of Québec’s birthing hospitals and birthing centres, in order to screen for critical congenital heart disease and any other hypoxemic condition. This main recommendation is accompanied by a series of additional considerations. (CLINICAL AND PROFESSIONAL ASPECTS): • Similar to assessing vital signs to verify the health of an asymptomatic newborn, pulse oximetry should be considered as an additional tool for the early management of a newborn who might have a serious condition. • As part of good clinical practice standards, the use of pulse oximetry would be implicitly included in the consent to care signed by the parents, but the health professional would have to inform them, as for any other procedure, of what is about to be done. • Under no circumstances should pulse oximetry replace existing standards of care, such as the physical examination. • The pulse oximetry protocol should be based on that of the Canadian Paediatric Society (Appendix F), while allowing a certain amount of flexibility so that all Québec newborns can be tested within a reasonable amount of time, including those in intensive care units. • The professionals involved in this practice should record the pulse oximetry test result and the subsequent course of action in the newborn’s chart, in accordance with the regulatory standards to which they are required to adhere in their practice. (ASPECTS REGARDING THE RGANIZATION OF CARE AND SERVICES AND SUPPORT OF CARE QUALITY): • Given that a large proportion of centres have already put the recommended practice in place, efforts to optimize the implementation of pulse oximetry should be aimed at engaging those birthing hospitals and birthing centres that have not yet done so. • A list of minimum specifications required for pediatric pulse oximeters could be made available to staff. To reduce costs, the use of reusable probes should be encouraged, depending on the setting and availability of such probes. • Human and material resources for implementing this good clinical practice standard in birthing hospitals and birthing centres must be sufficient to ensure the quality of care for newborns. • The various professional orders and associations concerned should facilitate the dissemination of this recommendation and support its integration into their members’ practice. An online training tool could be developed to support professionals in interpreting pulse oximetry test results. The academic training of future professionals who perform this test could also be strengthened to take the present recommendations into account. • To ensure the quality of the procedure, the identification of congenital cardiopathy and other hypoxemic conditions of the newborn by pulse oximetry could be the subject of an evaluation project by the medical quality assurance committees, or by the departments or the birthing centres concerned. Such a project could provide a portrait of the practice as well as an assessment of its impact on neonatal care.

Authors' methods: To fulfil this mandate, the scientific literature was systematically searched for data on the performance, efficacy and safety of the pulse oximetry test for detecting critical congenital heart disease in newborns. Contextual and experiential data were collected from perinatal professionals, a patient association, and parents or caregivers of children with heart disease. The organizational issues related to the use of the pulse oximetry test (timing of the test, site and algorithm) and the optimal implementation approaches (new program, existing program or preventive clinical practice) in the Québec context were discussed with experts on an advisory committee and with members of a monitoring committee consisting of representatives from the various organizations and associations concerned. The entirety of the data (scientific, contextual and experiential) was submitted to the Comité d’excellence clinique en dépistage des maladies chroniques for deliberation on the final recommendation.

Project Status: Completed

URL for project: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/pertinence-du-depistage-neonatal-des-cardiopathies-congenitales-graves-par-saturometrie-oxymetrie-de-pouls.html

Year Published: 2021

URL for published report: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/pertinence-du-depistage-neonatal-des-cardiopathies-congenitales-graves-par-saturometrie-oxymetrie-de-pouls.html

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Canada

Province: Quebec

Organisation Name: Institut national d'excellence en sante et en services sociaux

Contact Address: L'Institut national d'excellence en sante et en services sociaux (INESSS) , 2021, avenue Union, bureau 10.083, Montreal, Quebec, Canada, H3A 2S9;Tel: 1+514-873-2563, Fax: 1+514-873-1369

Contact Name: demande@inesss.qc.ca

Contact Email: demande@inesss.qc.ca

Copyright: Gouvernement du Québec