Re: Diaphragmatic Hernia

From: Dave Berck (djberck@yahoo.com)
Thu Nov 13 07:57:35 2003


Is anybody shocked by this? Fetal surgery seems to me, with rare exception, to be a procedure in search of an indication (not unlike doppler, but that's another story . . . .)

--- "art fougner, md" <evsono@pipeline.com> wrote: > In today's New England Journal of Medicine, Harrison
> et al reports that
> In Utero Therapy with Fetal Tracheal Occlusion did
> NOT improve perinatal
> outcomes.
>
> A Randomized Trial of Fetal Endoscopic Tracheal
> Occlusion for Severe
> Fetal Congenital Diaphragmatic Hernia
>
> Michael R. Harrison, M.D., Roberta L. Keller,
> M.D., Samuel B. Hawgood,
> M.D., Joseph A. Kitterman, M.D., Per L. Sandberg,
> M.D., Diana L.
> Farmer, M.D., Hanmin Lee, M.D., Roy A. Filly, M.D.,
> Jody A. Farrell,
> M.S.N., P.N.P., and Craig T. Albanese, M.D.
>
> ABSTRACT
>
> Background Experimental and clinical data suggest
> that fetal endoscopic
> tracheal occlusion to induce lung growth may improve
> the outcome of
> severe congenital diaphragmatic hernia. We
> performed a randomized,
> controlled trial comparing fetal tracheal occlusion
> with standard
> postnatal care.
>
> Methods Women carrying fetuses that were between 22
> and 27 weeks of
> gestation and that had severe, left-sided congenital
> diaphragmatic
> hernia (liver herniation and a lung-to-head ratio
> below 1.4), with no
> other detectable anomalies, were randomly assigned
> to fetal endoscopic
> tracheal occlusion or standard care. The primary
> outcome was survival
> at the age of 90 days; the secondary outcomes were
> measures of maternal
> and neonatal morbidity.
>
> Results Of 28 women who met the entry criteria, 24
> agreed to
> randomization. Enrollment was stopped after 24
> patients had been
> enrolled because of the unexpectedly high survival
> rate with standard
> care and the conclusion of the data safety
> monitoring board that further
> recruitment would not result in significant
> differences between the
> groups. Eight of 11 fetuses (73 percent) in the
> tracheal-occlusion
> group and 10 of 13 (77 percent) in the group that
> received standard care
> survived to 90 days of age (P=1.00). The severity
> of the congenital
> diaphragmatic hernia at randomization, as measured
> by the lung-to-head
> ratio, was inversely related to survival in both
> groups. Premature
> rupture of the membranes and preterm delivery were
> more common in the
> group receiving the intervention than in the group
> receiving standard
> care (mean [±SD] gestational age at delivery,
> 30.8±2.0 weeks vs.
> 37.0±1.5 weeks; P<0.001). The rates of neonatal
> morbidity did not
> differ between the groups.
>
> Conclusions Tracheal occlusion did not improve
> survival or morbidity
> rates in this cohort of fetuses with congenital
> diaphragmatic hernia.
>
> Source Information
>
> >From the Fetal Treatment Center (M.R.H., S.B.H.,
> J.A.K., P.L.S., D.L.F.,
> H.L., R.A.F., J.A.F., C.T.A.), the Departments of
> Surgery (M.R.H.,
> D.L.F., H.L., J.A.F., C.T.A.), Pediatrics (M.R.H.,
> R.L.K., S.B.H.,
> J.A.K., D.L.F., H.L., C.T.A.), Obstetrics,
> Gynecology and Reproductive
> Sciences (M.R.H., P.L.S., D.L.F., H.L., R.A.F.,
> C.T.A.), and Radiology
> (R.A.F.), and the Cardiovascular Research Institute
> (R.L.K., J.A.K.),
> University of California, San Francisco, San
> Francisco.
>
> art
>
> --
> art fougner, md
> ich bin ein New Yorker

===== David J. Berck, MD, MPH




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