Health Problem: Congenital diaphragmatic hernia (CDH) is an abnormal development of the diaphragm that allows for organs such as the stomach, liver, and bowel to protrude into the chest cavity. Pulmonary hypoplasia (lung underdevelopment) and impaired function result, leading to respiratory insufficiency and possibly causing potentially fatal persistent pulmonary hypertension. The left side alone is affected in 80% to 85% of fetuses. The incidence of CDH in the general population is estimated to be 1 in every 2200 fetuses and from 1 in 2200 to 1 in 5000 live births.

Technology Description: Fetoscopic endoluminal tracheal occlusion (FETO) is the current dominant fetal surgery for CDH. Goals of FETO include reduction of pulmonary hypoplasia and improvement in lung function and fetal outcomes. FETO is a minimally invasive endoscopically performed surgery that employs placement of a balloon in the fetus’ trachea.

Controversy: Fetal surgery of any kind presents health risks to both the fetus and the healthy mother, and whether benefits outweigh risks, particularly for preterm labor, is debated. Due to the risks of fetal surgery, it is currently generally reserved for severe isolated CDH without substantive comorbidity; however, accurate assessment of severity and prediction of outcomes is not always clear.

Key Questions: The report addresses the following key questions:

  • Does FETO improve clinical outcomes of CDH, compared with standard postnatal care?
  • What risks does FETO present to the fetus and its mother?
  • What are the patient selection criteria for FETO?

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