Fetal Intervention of CDH: Past, No Disclosures Present and Future - - PowerPoint PPT Presentation

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Fetal Intervention of CDH: Past, No Disclosures Present and Future - - PowerPoint PPT Presentation

Fetal Intervention of CDH: Past, No Disclosures Present and Future Hanmin Lee, MD Director, Fetal Treatment Center, UCSF 3/10/2017 Our Early Beginnings Fetal Rx: Judging Risks vs. Benefits The Concept: Fix simple anatomic defects which lead


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[ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS] 3/10/2017 1

Fetal Intervention of CDH: Past, Present and Future

Hanmin Lee, MD Director, Fetal Treatment Center, UCSF

No Disclosures

3/10/2017

Our Early Beginnings

The Concept: Fix simple anatomic defects which lead to disastrous physiologic consequences

Fetal Rx: Judging Risks vs. Benefits

Risks to Mother Benefits/Risks to Fetus

Future Benefits to

Fetal Patient

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First Animal Studies - 1981

Hysterotomy for fetal surgery & maternal safety demonstrated in a monkey model.

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Clinical trials are essential to establish the place of promising new surgical therapies, before they are considered “standard” treatment

“Liver-down” CDH

Fetal surgery works

NOT NECESSARY

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LHR

Lung area / Head circumference The lung area contralateral to the CDH is measured at the 4- chamber view of the heart on a transverse scan of the fetal thorax. The product is divided by the head circumference to obtain the LHR.

Metkus A, Journal of Peds Surgery, 1996 (31)Jan 148- 152.

Gestational Age Dependent: Prior to 26 weeks

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FETAL SURGERY vs POSTNATAL CARE: A Randomized Controlled Trial for CDH

BACKGROUND 1980 Experimental CDH Repair 1986 Open CDH Repair 1992 Trial: Open Repair vs Postnatal Care 1994 Experimental Tracheal Occlusion 1996 Open Plug 1997 Open Clip 1999 Fetendo Clip 2000 Fetendo Balloon

FETAL SURGERY vs POSTNATAL CARE: A Randomized Controlled Trial

DESIGN: Inclusion: isolated anomaly, CDH Liver up < 25 wks, LHR < 1.4 Exclusion: Failure to meet all inclusion criteria, right- sided CDH, family refuses randomization or unable to stay in SF 1º Outcome: Mortality 2º Outcome: Long-term morbidity # Subjects Necessary N = 40 Survival 40% → 75% (α = 0.05, β = 0.2)

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Conclusions

Randomized controlled trial feasible

  • Acceptance: High (24/28 randomized)

Low Maternal/Fetal Morbidity

  • PROM (64%)
  • Prematurity (30.8 ± 2 weeks)

90 Day Survival (interim analysis)

  • Occlusion 8/11 (73%)
  • Control 10/13 (77%)

Survival proportional to LHR

European Experience/FETO Task Group

Centers in Leuven, London, Barcelona joined in 2001 “FETO”- Fetal Endoscopic Tracheal Occlusion 24 patients between April 2002 and August 2004 Liver up, LHR=1.0 or less Surgery at 26 to 28 weeks gestation Survival Neonatal = 75% 28 day = 58% Hospital Discharge = 50%

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Observed/expected lung-to-head ratio

( o/e LHR) LHR increases with gestational age Independent of gestational age

  • /e LHR- = (observed

LHR/expected LHR x 100

Jani J. Ultrasound Obstet Gynecol. 2007. Jul:30(1):67-71

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Tracheal Occlusion To Accelerate Lung Growth – (TOTAL)

FETO Task Group Tests hypothesis: does prenatal intervention increase survival and/or morbidity in isolated CDH Patient choice

  • Join RCT
  • Elect TO in the observational arm

Standardized fetal, prenatal and neonatal care O/E LHR < 25% - Increase survival by 50% O/E LHR 26-45% - Increase survival and decrease BPD Now a European and NAFNET collaboration

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Fetal Markers for Pulmonary Hypertension

LPA/RPA diameter

  • RPA but not LPA larger in survivors compared to nonsurvivors

(Okazaki et al. JPS 2011) Prenatal MPA/contralateral PA larger in survivors with CDH and smaller MPA/contralteral PA marker for PH (Ruano et al, Ultrasound

  • bstet gyn 2011)

Fetal Ultrasound: LHR(<1.0), liver position(thoracic), stomach position(retrocardiac) correlate with delayed resolution of pulmonary hypertension (Lusk … Keller Am J Obstet Gynecol 2015)

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Does Tracheal Occlusion improve PH?

LPA larger postnatally in patients with CDH undergoing TO (Rocha…Moon-Grady 2014 Fetal Diagn Ther)

  • LV length, LV: RV ratio, LVED volume also improved after TO

RCT: Decreased incidence of PH/Increased survival patients undergoing TO for severe CDH (Ruano et al, Ultrasound Obstet Gynecol 2012)

  • PH defined by RL or bidirectional shunt or pre to postductal

gradient >20%

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Future Directions

Use of vasodilators prenatally Use of corticosteroids prenatally Optimal timing and duration of Tracheal Occlusion Time limited TO device Intermittent TO device Combination therapies of above

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