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Fetoscopic Temporary Tracheal Occlusion for Congenital Diaphragmatic Hernia: Prelude to a Randomized, Controlled Trial

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Fetoscopic Temporary Tracheal Occlusion for Congenital Diaphragmatic Hernia: Prelude to a Randomized, Controlled Trial Fetoscopic Temporary Tracheal Occlusion for Congenital Diaphragmatic Hernia: Prelude to a Randomized, Controlled Trial By Michael R. Harrison, Roman M. Sydorak, Jody A. Farrell, Joseph A. Kitterman, Roy A. Filly, and Craig T. Albanese San Francisco, California Objective: As previously reported, high postnatal mortality after delivery; one died in utero, and 5 died after birth. Late seen in fetuses with congenital diaphragmatic hernia (CDH) mortality included one death caused by sepsis and 2 by with liver herniation and low lung-to-head ratio (LHR) ap- complications associated with tracheostomies. Morbidity pears to be improved in fetuses who undergo fetoscopic from gastroesophageal reflux requiring Nissen fundoplica- temporary tracheal occlusion (TO). To test whether further tion, tracheal injury requiring repair or tracheostomy, and evolution of this technique produces results that justify a recurrent hernias after diaphragmatic repair were character- randomized controlled trial comparing prenatal intervention istic in longterm survivors. to postnatal care, the authors analyzed 11 additional cases and the cumulative experience with 19 cases. Conclusions: Fetoscopic temporary TO may improve out- come in poor-prognosis fetuses with CDH. However, compli- Methods: The authors analyzed retrospectively the outcome cations related to tracheal dissection, premature delivery and of 11 new and 8 previously reported cases of fetoscopic late morbidity are significant. This experience has led to temporary tracheal occlusion. Various factors were studied simpler techniques for fetoscopic tracheal occlusion and to including maternal morbidity, antenatal outcome, physio- an National Institutes of Health–sponsored randomized con- logic lung response, and neonatal course. trolled trial comparing fetoscopic tracheal occlusion with optimal postnatal care. Results: Temporary TO can be accomplished using 3 5-mm J Pediatr Surg 38:1012-1020. © 2003 Elsevier Inc. All rights radially expanding uterine ports without hysterotomy. Ob- reserved. stetric morbidity included mild pulmonary edema in 6 cases, chorioamniotic separation and premature rupture of mem- INDEX WORDS: Congenital diaphragmatic hernia, fetal sur- branes in 12 patients, and preterm labor and delivery in all gery, fetoscopy, tracheal occlusion, prenatal diagnosis, clin- patients. Thirteen of 19 (68%) neonates survived for 90 days ical trial. ULMONARY HYPOPLASIA and pulmonary hy- occlusion, by preventing the normal egress of lung fluid, P pertension are devastating consequences of infants stimulates lung growth and reverses the pulmonary hy- born with congenital diaphragmatic hernia (CDH). De- poplasia and hypertension that are the characteristic spite aggressive postnatal care and advances in neonatal causes of morbidity and mortality in these neonates.4-6 In therapy, high-risk fetuses, those with liver herniation into utero temporary tracheal occlusion using endoscopic the chest and with lung-to-head ratios (LHR) less than techniques (Fetendo) has a similar effect in both animal 1.4, continue to do poorly with little improvement in models.7 and in human fetuses.8 survival rate.1 Years of work, initially in experimental We previously reported that in 8 fetuses with severe animal models and later in humans, have attempted to left CDH, prenatal intervention with the Fetendo clip improve the outcome of fetuses with CDH by interven- procedure resulted in 75% survival rate compared with 8,9 ing prenatally. Attempts at open hysterotomy and repair 38% for a matched cohort treated postnatally. We now of the diaphragmatic defect did not improve outcomes in report our experience with 11 additional cases. Review of these cases suggests that endoscopic placement of randomized control and retrospective studies.2,3 More external tracheal clips may improve outcome for fetuses recent efforts have utilized an alternative strategy, occlu- with the most severe CDH and has led to an National sion of the trachea, to allow the lungs to grow. Tracheal Institutes of Health (NIH)-sponsored trial comparing Fetendo clip to optimal postnatal care including extra- From the Departments of Surgery, Pediatrics, and Radiology, The corporeal membrane oxygenation (ECMO), inhaled ni- Fetal Treatment Center, University of California, San Francisco, CA tric oxide, and high-frequency ventilation. Address reprint requests to Michael R. Harrison, MD, The Fetal Treatment Center, University of California, San Francisco, 513 Par- nassus Ave, HSW-1601, San Francisco CA 94143-0570. MATERIALS AND METHODS © 2003 Elsevier Inc. All rights reserved. From January 1996 to April 1999, 19 fetuses underwent fetoscopic 0022-3468/03/3807-0005$30.00/0 temporary tracheal occlusion (Fetendo clip) for congenital diaphrag- doi:10.1016/S0022-3468(03)00182-9 matic hernia (CDH) at the University of California at San Francisco 1012 Journal of Pediatric Surgery, Vol 38, No 7 (July), 2003: pp 1012-1020 FETOSCOPIC TRACHEAL OCCLUSION 1013 Fig 1. Method for occluding the trachea with clips. Under sono- graphic guidance, the fetus’ neck is exposed and the head stabilized by placing a temporary transuterine chin suture. Using ultrasonography, a T-fastener and suture are placed in the fetal trachea to aid in locating the midline fetal neck. After anterior tracheal dissection, a tracheal “screw” can be placed in the ante- rior tracheal wall to facilitate safe posterolateral dissection, if neces- sary. (UCSF) Fetal Treatment Center. We now update the previously re- at the time of planned intervention to improve fetal lung tissue com- ported experience with 8 left-sided CDHs3 with an additional 8 left- pliance.11,12 Whereas pre- and intraoperative tocolytic management sided and 3 right-sided CDH patients. remained the same (indomethacin, halogenated anesthetic agents, and Fetuses eligible for prenatal intervention met criteria including (1) small doses of nitroglycerin when necessary for acute intraoperative diagnosis of CDH made before 25 weeks’ gestation, (2) a major portion uterine relaxation), postoperative tocolysis has evolved and has been of the liver herniated into the hemithorax, (3) lung-to-head ratio (LHR) standardized through use of a clinical pathway (Table 1). Because less than 1.4 for left CDHs,1 (4) normal karyotype and echocardiogram, ␤-adrenergic agonists reduce the production of fetal lung fluid exper- and (5) no other anomalies detected by prenatal ultrasonography. imentally,13,14 they are now used sparingly. Magnesium sulfate, which Before fetal intervention, a multidisciplinary team including a pediatric is begun near the completion of the case, is weaned within 1 to 2 days, surgeon, perinatologist, neonatologist, psychiatric social worker, and and an oral calcium channel blocker (Nifedipine) is used for mainte- anesthesiologist rigorously counseled all candidate families. Each fam- nance tocolysis until delivery. The decision to discharge patients was ily was offered the following options: (1) standard postnatal care, (2) made when there was no evidence of membrane rupture or separation, termination (if before 24 weeks’ gestation), or (3) fetal temporary and preterm labor could be controlled with orally administered toco- tracheal occlusion. During the period of this study, 45 families fulfilled lytics. all criteria. Of these, 19 families chose fetal intervention, 7 decided to After discharge, all mothers with fetal intervention stayed at a nearby terminate the pregnancy, and 19 opted for conventional postnatal care. Ronald McDonald House on bedrest precautions and underwent bi- All fetal temporary tracheal occlusion procedures were performed weekly examination including fetal ultrasonography. All fetuses with under an institutionally approved IRB protocol. the Fetendo clip were delivered using the EXIT (ex utero intrapartum For those who chose to undergo fetal intervention, a fetoscopic treatment) procedure as described previously.3,15 The fetus, while still approach (the Fetendo clip procedure) was attempted first, and, only if on placental support, is delivered partially. The fetal neck is exposed unsuccessful, an open hysterotomy would be performed. Although the and the clips removed with rigid bronchoscopic visualization. Lung original procedure has been described in detail,3,9,10 briefly, the Fetendo fluid is aspirated, and surfactant is given immediately after endotra- clip procedure entails a maternal laparotomy with exposure of the cheal intubation. After establishment of an effective airway and good uterus. Using ultrasonic guidance, the fetus is fixed in neck extension chest excursion, the infant is delivered and the umbilical cord clamped. position with a chin stitch, and the trachea is isolated with a T-bar (Fig Postnatal management of infants included high-frequency ventilation, 1). In addition to general anesthesia via maternoplacental circulation, ECMO for salvage therapy, and nitric oxide in cases of severe pulmo- the fetus is relaxed with an intramuscular Pancuronium and Fentanyl nary hypertension. Repair of the diaphragmatic hernia was performed injection. Fetoscopic instruments then are used to dissect the trachea, electively when the baby was stable, from 2 to 8 days after birth. identify the recurrent laryngeal nerves, and apply 2 titanium transtra- Postnatal care in all infants included admission to the Intensive Care cheal occluding clips. A specially designed perfusion pump that pro- Nursery with maximal ventilatory support including high-frequency vides warmed irrigation and suction, maintaining the fetus in a homeo-
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