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Fetal Surgery for Myelomeningocele
    1-800-IN UTERO (468-8376) • fetalsurgery.chop.edu
A Guide to Specialized Fetal MMC Surgical Repair

                 Since December 2010, fetal surgery for myelomeningocele
                 (MMC), the most common and severe form of spina bifida,
                 has been offered as a standard of care at The Children’s Hospital
                 of Philadelphia. This is one of the most exciting developments
                 in the history of treatment for birth defects.

                 An extremely complex procedure available only to qualified
                 candidates, fetal surgery for MMC requires significant
                 commitment on the part of mothers who choose to go forward
                 with it and extensive surgical experience to perform successfully.
                 Mothers who choose fetal surgery require comprehensive
                 counseling on the condition and the risks involved in the
                 procedure.

                 This guide provides an overview of fetal MMC repair,
                 including confirmation of the diagnosis, patient criteria for
                 fetal surgery, the surgical procedure, delivery and follow-up
                 care. We welcome the opportunity to discuss individual
                 candidates for referral.
Types of Spina Bifida			
                                                                                      2

• MMC (Myelomeningocele)



                              s
• Myeloschisis
                                                                                                     1
• Lipomeningocele
• Myelocystocele


Open neural tube defects
such as myelomeningocele
and myeloschisis are
treatable by fetal repair.
                                  Fetus with myelomeningocele
Closed neural tube defects        1. Part of the spinal cord and spinal nerves, usually encased in a sac, protrude
such as lipomeningocele and          through an opening in the back and are exposed to the amniotic fluid.
myelocystocele are not            2. Arnold-Chiari II Malformation • The brain stem (hindbrain) descends, or
                                     herniates, into the spinal canal in the neck and blocks the circulation of
treatable by fetal repair.
                                     cerebrospinal fluid. This can cause a damaging buildup of fluid in the brain
                                     called hydrocephalus.
Facts About Myelomeningocele (MMC)

• Most common and serious form of spina bifida                 Long-term
• Primary failure of neural tube formation (closure)           Consequences
• Genetic and micronutrient causes                             • Hydrocephalus
• 1 per 2,000 live births, or 1,500 babies in U.S. each year   • Hindbrain herniation
                                                                 complications
• 14% die before age 5; 2/3 due to hindbrain                   • Ventriculoperitoneal
  herniation complications                                       shunting
• 85% require shunts; 45% of shunts develop                    • Paralysis and cognitive
  complications within 1 year                                    impairments
                                                               • Orthopaedic malformations
• Up to 4% recurrence risk in subsequent pregnancies            (such as club foot)
                                                               • Bladder and bowel
                                                                 incontinence
                                                               • Sexual dysfunction
                                                               • Social and emotional
                                                                 challenges
                                                               • Lifelong quality-of-life issues
Motor Impairment Related to Level of Defect
                                                            Cervical 1
                                                                     2
                                                                     3
MMC can occur       Areas below the level of                         4
                                                                     5
at any level in     the defect will be affected.                     6
                                                                     7
the developing                                                       8
                    This illustration shows a               Thoracic 1
spine, but occurs   defect at the L 4-5 level.
                                                                     2
                                                                     3
most often in                                                        4
                                                                     5
the lumbosacral                                                      6
                                                                     7
region.                                                              8
                                                                     9
                                                                    10
The higher the                                                      11

defect on the                                                       12
                                         Skin
spine, the more                                             Lumbar 1
                                                                         Muscle Areas Affected
                                                      Sac           2
severe the                                                               Hip
                                                                    3
complications.                                                      4
                                                                         Knee

                                  Exposed nerves                         Ankle (dorsiflexors)
                                                                    5
                                                                         Great Toe
                                                Sac          Sacral 1
                                                                         Ankle (plantarflexors)
                                                                    2
                                                                    3    Bowel & Bladder
                                                                    4
                                                                    5
Steps in Making the Diagnosis

             1. Maternal serum alpha-fetoprotein (MSAFP) test.
                Abnormally high AFP levels can suggest neural
                tube defect.

             2. Level II ultrasound to confirm spinal defect, determine
                level of lesion, confirm features in the brain that
                indicate spina bifida and assess deformities such as
                talipes (club foot).

             3. Amniocentesis to confirm presence of elevated
                amniotic fluid alpha-fetoprotein (AFAFP) levels and
                acetylcholinesterase (AChE), which indicates open
                (vs. closed) neural tube defect. Amniocentesis is
                required to be considered for fetal surgery.
Rationale for Fetal MMC Surgery
                                                         Results of Management of Myelomeningocele Study (MOMS)*
Spinal cord damage                                       showing outcomes after prenatal repair vs. postnatal repair:
is progressive during
gestation. Fetal MMC                                     • Reduced need for ventricular shunting at 12 months of age
                                                           (40% of prenatal surgery group, compared to 83% of
surgery may prevent                                        postnatal surgery group)
further damage and
                                                         • Reduced incidence or severity of neurologic effects, e.g.,
reverse the hindbrain                                      impaired motor and sensory function of legs
herniation feature
                                                         • Improved ambulation at 30 months of age
of the Arnold-Chiari II
                                                         • Reversal of hindbrain herniation component of Arnold-Chiari II
malformation.                                              malformation

                                                                            Before surgery                      After surgery




*N. Scott Adzick, M.D. et al.,“A Randomized Trial of
Prenatal versus Postnatal Repair of Myelomeningocele,”
N Engl J Med. 2011 Mar 17;364(11):993-1004.
Epub 2011 Feb 9.
When is Fetal Surgery for MMC an Option?

Partial list of inclusion criteria:
• Singleton pregnancy
• Maternal BMI < 35
• Confirmed presence of elevated AFAFP
  and AChE
• Confirmed normal genetic testing
• Absence of associated fetal anomalies
• Myelomeningocele at level T1 through S1
• Arnold-Chiari II malformation              There is an extensive list of
  (hindbrain herniation)
                                             inclusion and exclusion criteria
• Gestational age at time of fetal surgery
                                             for fetal MMC repair at CHOP.
  ≤ 25 weeks, 6 days
                                             For a complete listing, visit
• Maternal age ≥ 18 years
                                             fetalsurgery.chop.edu/spinabifida
                                             or call 1-800-IN UTERO (468-8376).
Evaluation at the Center for Fetal Diagnosis and Treatment
                                     Diagnostic testing:
A comprehensive
multidisciplinary                    • High-resolution level II ultrasound to confirm location of MMC
evaluation.                            and assess for other birth defects
                                     • Ultrafast fetal MRI to confirm presence of Arnold-Chiari II
                                       malformation and screen for evidence of other brain or spinal
                                       abnormalities and any other structural defects not related to MMC
                                     • Fetal echocardiogram to evaluate heart structure and function

                                                                                               continued




                                                                                                           s
                                    Ultrasound                                  Fetal MRI
Near Right:
Ultrasound image showing
myelomeningocele sac containing
neural elements

Far Right:
Fetal MRI showing hindbrain
herniation, myelomeningocele sac
containing neural elements and no
extra-axial cerebrospinal fluid
Evaluation at the Center for Fetal Diagnosis and Treatment

               continued

               Patient counseling and education:

               • Review of spina bifida and associated medical problems, and prenatal
                 and postnatal options with obstetrician and neurosurgeon
               • Physical exam of mother, review of medical history and clearance
                 for surgery by anesthesiologist and obstetrician
               • Review of pre- and postnatal care and monitoring
               • Neonatology counseling about possible preterm birth
               • Review of medications necessary before, during and after
                 prenatal surgery
               • Social work psychosocial evaluation to assess readiness for surgery,
                 coping mechanisms and family support
               • Review of surgical procedure (if opting for fetal surgery) and its risks
                 with fetal surgeon. Risks include uterine scarring, membrane
                 separation, infection, bleeding, prematurity and fetal demise.
Fetal MMC Surgery
                                   • Mother and fetus receive general anesthesia
                                   • Fetal surgeon performs laparotomy and uterus is opened with uterine
                                     stapling device that pinches off all blood vessels and keeps membranes
                                     tacked up to muscle layer of uterus
                                   • Sterile intraoperative ultrasound is performed by maternal-fetal
                                     medicine specialist
                                   • Fetus’ back is rotated into view
                                   • Fetal cardiologist performs continuous fetal heart monitoring
                                     by echocardiography
                                   • Pediatric neurosurgeon resects MMC sac from exposed spinal cord
                                     (neural placode) and skin edges, returns cord to spinal canal, and closes
                                     surrounding tissue and skin over defect
                                   • Uterine and abdominal incisions are closed



N. Scott Adzick, M.D. et al.,
“A Randomized Trial of Prenatal
versus Postnatal Repair of
Myelomeningocele,” N Engl J Med.
2011 Mar 17;364(11):993-1004.
Epub 2011 Feb 9.
From Fetal Closure to Delivery
          • Mother remains in hospital 3 –5 days if no complications
          • Modified bed rest for 3 – 4 weeks; restricted activity until delivery
          • Weekly ultrasound monitoring
          • Goal is planned c-section at 37 weeks
          • Postnatal care in Newborn Intensive Care Unit (NICU)
NICU Stay
Upon admission,         • Head ultrasounds day of life 0 and prior to discharge
multidisciplinary       • MRI of brain and spine
consult with:           • Daily head circumference

• Neurosurgery          • Renal and bladder ultrasound day of life 2

• Urology               • Bladder scans with handheld ultrasound device every 4 hours
                          for first 48 hours to estimate amount of urine in bladder
• Orthopaedics            and whether baby requires catheter
• Physical Therapy      • Clean intermittent catheterization if bladder volume is greater
• Spina Bifida Clinic     than 50 percent of expected volume
                        • Video-urodynamics day of life 2 and then at 2 months of age –
                          special catheter measures pressure when bladder is full; soft catheter
                          in rectum measures abdominal pressure on bladder; uroflow chair
                          measures urine flow rate and time needed to empty bladder
                        • Urinary tract infection prophylaxis
                        • Evaluation for shunt
Follow-up

Our Center is committed      • Patients receiving follow-up care through CHOP are seen
to the comprehensive           in our Spina Bifida Clinic the nation’s first program to
                               bring a multidisciplinary approach to long-term follow-up.
long-term follow-up of
                               The clinic includes experts from pediatrics, nursing,
our patients, to provide       neurosurgery, orthopaedics, urology, physical therapy,
the best care for children     social work and genetics.
and their families,          • Follow-up includes visits every four to six months until
and to continuously gain       age 2, then annually, with urodynamic testing and renal
new knowledge so that          bladder ultrasounds to ensure kidneys function properly
we can advance care for        and bladder function is stable.
future generations.          • Depending upon location of lesion and outcome after surgery,
                               follow-up may also include: Clean intermittent catheterization;
                               bowel management; lower extremity bracing; physical therapy
                               evaluation and guidance to outside physical therapists and
                               early intervention; pressure sore management; referral to
                               appropriate psychosocial and financial resources; consultation
                               with other subspecialties including ophthalmology,
                               nephrology, nutrition and feeding team, and plastic surgery.
CHOP Experience in Fetal MMC Repair

Suspected prenatal diagnosis                                                   An unparalleled level of
of myelomeningocele (MMC)                                                      continuous experience:
since September 1995:
                                                                               • Leaders in development
                                                                                 and research of fetal MMC
	         Patient referrals: Over 1,450                                          repair for over 30 years
	         Patient evaluations: Nearly 700                                      • First fetal MMC repair
                                                                                 performed in 1998
	         Fetal surgeries: Over 125
                                                                               • Performed 58 fetal MMC
                                                                                 repairs, meeting strict
About 1 in every 3-4 patients evaluated                                          inclusion criteria, before
is a candidate for fetal repair.                                                 start of MOMS trial
                                                                               • More than 800 fetal surgeries
                                                                                 (all diagnoses) for patients
                                                                                 from all 50 states and more
                                                                                 than 50 countries
Center for Fetal Diagnosis and Treatment at CHOP, data on file as of 1/31/12
Key Resources

            The Children’s Hospital of Philadelphia
            • Center for Fetal Diagnosis and Treatment
              fetalsurgery.chop.edu/spinabifida
              1-800-IN UTERO (468-8376)
            • Spina Bifida Clinic
                215-590-2483

            Spina Bifida Association of America
            www.sbaa.org

            Centers for Disease Control and Prevention
            www.cdc.gov/ncbddd/spinabifida

            Spina Bifida Connection
            http://spinabifidaconnection.com

            March of Dimes
            www.marchofdimes.com
Referrals • Appointments • Information
1-800-IN UTERO (468-8376) • fetalsurgery.chop.edu




    © 2012 The Children’s Hospital of Philadelphia. All Rights Reserved.   5588/1M/02-12

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Fetal Surgery for Spina Bifida

  • 1. Fetal Surgery for Myelomeningocele 1-800-IN UTERO (468-8376) • fetalsurgery.chop.edu
  • 2. A Guide to Specialized Fetal MMC Surgical Repair Since December 2010, fetal surgery for myelomeningocele (MMC), the most common and severe form of spina bifida, has been offered as a standard of care at The Children’s Hospital of Philadelphia. This is one of the most exciting developments in the history of treatment for birth defects. An extremely complex procedure available only to qualified candidates, fetal surgery for MMC requires significant commitment on the part of mothers who choose to go forward with it and extensive surgical experience to perform successfully. Mothers who choose fetal surgery require comprehensive counseling on the condition and the risks involved in the procedure. This guide provides an overview of fetal MMC repair, including confirmation of the diagnosis, patient criteria for fetal surgery, the surgical procedure, delivery and follow-up care. We welcome the opportunity to discuss individual candidates for referral.
  • 3. Types of Spina Bifida 2 • MMC (Myelomeningocele) s • Myeloschisis 1 • Lipomeningocele • Myelocystocele Open neural tube defects such as myelomeningocele and myeloschisis are treatable by fetal repair. Fetus with myelomeningocele Closed neural tube defects 1. Part of the spinal cord and spinal nerves, usually encased in a sac, protrude such as lipomeningocele and through an opening in the back and are exposed to the amniotic fluid. myelocystocele are not 2. Arnold-Chiari II Malformation • The brain stem (hindbrain) descends, or herniates, into the spinal canal in the neck and blocks the circulation of treatable by fetal repair. cerebrospinal fluid. This can cause a damaging buildup of fluid in the brain called hydrocephalus.
  • 4. Facts About Myelomeningocele (MMC) • Most common and serious form of spina bifida Long-term • Primary failure of neural tube formation (closure) Consequences • Genetic and micronutrient causes • Hydrocephalus • 1 per 2,000 live births, or 1,500 babies in U.S. each year • Hindbrain herniation complications • 14% die before age 5; 2/3 due to hindbrain • Ventriculoperitoneal herniation complications shunting • 85% require shunts; 45% of shunts develop • Paralysis and cognitive complications within 1 year impairments • Orthopaedic malformations • Up to 4% recurrence risk in subsequent pregnancies (such as club foot) • Bladder and bowel incontinence • Sexual dysfunction • Social and emotional challenges • Lifelong quality-of-life issues
  • 5. Motor Impairment Related to Level of Defect Cervical 1 2 3 MMC can occur Areas below the level of 4 5 at any level in the defect will be affected. 6 7 the developing 8 This illustration shows a Thoracic 1 spine, but occurs defect at the L 4-5 level. 2 3 most often in 4 5 the lumbosacral 6 7 region. 8 9 10 The higher the 11 defect on the 12 Skin spine, the more Lumbar 1 Muscle Areas Affected Sac 2 severe the Hip 3 complications. 4 Knee Exposed nerves Ankle (dorsiflexors) 5 Great Toe Sac Sacral 1 Ankle (plantarflexors) 2 3 Bowel & Bladder 4 5
  • 6. Steps in Making the Diagnosis 1. Maternal serum alpha-fetoprotein (MSAFP) test. Abnormally high AFP levels can suggest neural tube defect. 2. Level II ultrasound to confirm spinal defect, determine level of lesion, confirm features in the brain that indicate spina bifida and assess deformities such as talipes (club foot). 3. Amniocentesis to confirm presence of elevated amniotic fluid alpha-fetoprotein (AFAFP) levels and acetylcholinesterase (AChE), which indicates open (vs. closed) neural tube defect. Amniocentesis is required to be considered for fetal surgery.
  • 7. Rationale for Fetal MMC Surgery Results of Management of Myelomeningocele Study (MOMS)* Spinal cord damage showing outcomes after prenatal repair vs. postnatal repair: is progressive during gestation. Fetal MMC • Reduced need for ventricular shunting at 12 months of age (40% of prenatal surgery group, compared to 83% of surgery may prevent postnatal surgery group) further damage and • Reduced incidence or severity of neurologic effects, e.g., reverse the hindbrain impaired motor and sensory function of legs herniation feature • Improved ambulation at 30 months of age of the Arnold-Chiari II • Reversal of hindbrain herniation component of Arnold-Chiari II malformation. malformation Before surgery After surgery *N. Scott Adzick, M.D. et al.,“A Randomized Trial of Prenatal versus Postnatal Repair of Myelomeningocele,” N Engl J Med. 2011 Mar 17;364(11):993-1004. Epub 2011 Feb 9.
  • 8. When is Fetal Surgery for MMC an Option? Partial list of inclusion criteria: • Singleton pregnancy • Maternal BMI < 35 • Confirmed presence of elevated AFAFP and AChE • Confirmed normal genetic testing • Absence of associated fetal anomalies • Myelomeningocele at level T1 through S1 • Arnold-Chiari II malformation There is an extensive list of (hindbrain herniation) inclusion and exclusion criteria • Gestational age at time of fetal surgery for fetal MMC repair at CHOP. ≤ 25 weeks, 6 days For a complete listing, visit • Maternal age ≥ 18 years fetalsurgery.chop.edu/spinabifida or call 1-800-IN UTERO (468-8376).
  • 9. Evaluation at the Center for Fetal Diagnosis and Treatment Diagnostic testing: A comprehensive multidisciplinary • High-resolution level II ultrasound to confirm location of MMC evaluation. and assess for other birth defects • Ultrafast fetal MRI to confirm presence of Arnold-Chiari II malformation and screen for evidence of other brain or spinal abnormalities and any other structural defects not related to MMC • Fetal echocardiogram to evaluate heart structure and function continued s Ultrasound Fetal MRI Near Right: Ultrasound image showing myelomeningocele sac containing neural elements Far Right: Fetal MRI showing hindbrain herniation, myelomeningocele sac containing neural elements and no extra-axial cerebrospinal fluid
  • 10. Evaluation at the Center for Fetal Diagnosis and Treatment continued Patient counseling and education: • Review of spina bifida and associated medical problems, and prenatal and postnatal options with obstetrician and neurosurgeon • Physical exam of mother, review of medical history and clearance for surgery by anesthesiologist and obstetrician • Review of pre- and postnatal care and monitoring • Neonatology counseling about possible preterm birth • Review of medications necessary before, during and after prenatal surgery • Social work psychosocial evaluation to assess readiness for surgery, coping mechanisms and family support • Review of surgical procedure (if opting for fetal surgery) and its risks with fetal surgeon. Risks include uterine scarring, membrane separation, infection, bleeding, prematurity and fetal demise.
  • 11. Fetal MMC Surgery • Mother and fetus receive general anesthesia • Fetal surgeon performs laparotomy and uterus is opened with uterine stapling device that pinches off all blood vessels and keeps membranes tacked up to muscle layer of uterus • Sterile intraoperative ultrasound is performed by maternal-fetal medicine specialist • Fetus’ back is rotated into view • Fetal cardiologist performs continuous fetal heart monitoring by echocardiography • Pediatric neurosurgeon resects MMC sac from exposed spinal cord (neural placode) and skin edges, returns cord to spinal canal, and closes surrounding tissue and skin over defect • Uterine and abdominal incisions are closed N. Scott Adzick, M.D. et al., “A Randomized Trial of Prenatal versus Postnatal Repair of Myelomeningocele,” N Engl J Med. 2011 Mar 17;364(11):993-1004. Epub 2011 Feb 9.
  • 12. From Fetal Closure to Delivery • Mother remains in hospital 3 –5 days if no complications • Modified bed rest for 3 – 4 weeks; restricted activity until delivery • Weekly ultrasound monitoring • Goal is planned c-section at 37 weeks • Postnatal care in Newborn Intensive Care Unit (NICU)
  • 13. NICU Stay Upon admission, • Head ultrasounds day of life 0 and prior to discharge multidisciplinary • MRI of brain and spine consult with: • Daily head circumference • Neurosurgery • Renal and bladder ultrasound day of life 2 • Urology • Bladder scans with handheld ultrasound device every 4 hours for first 48 hours to estimate amount of urine in bladder • Orthopaedics and whether baby requires catheter • Physical Therapy • Clean intermittent catheterization if bladder volume is greater • Spina Bifida Clinic than 50 percent of expected volume • Video-urodynamics day of life 2 and then at 2 months of age – special catheter measures pressure when bladder is full; soft catheter in rectum measures abdominal pressure on bladder; uroflow chair measures urine flow rate and time needed to empty bladder • Urinary tract infection prophylaxis • Evaluation for shunt
  • 14. Follow-up Our Center is committed • Patients receiving follow-up care through CHOP are seen to the comprehensive in our Spina Bifida Clinic the nation’s first program to bring a multidisciplinary approach to long-term follow-up. long-term follow-up of The clinic includes experts from pediatrics, nursing, our patients, to provide neurosurgery, orthopaedics, urology, physical therapy, the best care for children social work and genetics. and their families, • Follow-up includes visits every four to six months until and to continuously gain age 2, then annually, with urodynamic testing and renal new knowledge so that bladder ultrasounds to ensure kidneys function properly we can advance care for and bladder function is stable. future generations. • Depending upon location of lesion and outcome after surgery, follow-up may also include: Clean intermittent catheterization; bowel management; lower extremity bracing; physical therapy evaluation and guidance to outside physical therapists and early intervention; pressure sore management; referral to appropriate psychosocial and financial resources; consultation with other subspecialties including ophthalmology, nephrology, nutrition and feeding team, and plastic surgery.
  • 15. CHOP Experience in Fetal MMC Repair Suspected prenatal diagnosis An unparalleled level of of myelomeningocele (MMC) continuous experience: since September 1995: • Leaders in development and research of fetal MMC Patient referrals: Over 1,450 repair for over 30 years Patient evaluations: Nearly 700 • First fetal MMC repair performed in 1998 Fetal surgeries: Over 125 • Performed 58 fetal MMC repairs, meeting strict About 1 in every 3-4 patients evaluated inclusion criteria, before is a candidate for fetal repair. start of MOMS trial • More than 800 fetal surgeries (all diagnoses) for patients from all 50 states and more than 50 countries Center for Fetal Diagnosis and Treatment at CHOP, data on file as of 1/31/12
  • 16. Key Resources The Children’s Hospital of Philadelphia • Center for Fetal Diagnosis and Treatment fetalsurgery.chop.edu/spinabifida 1-800-IN UTERO (468-8376) • Spina Bifida Clinic 215-590-2483 Spina Bifida Association of America www.sbaa.org Centers for Disease Control and Prevention www.cdc.gov/ncbddd/spinabifida Spina Bifida Connection http://spinabifidaconnection.com March of Dimes www.marchofdimes.com
  • 17. Referrals • Appointments • Information 1-800-IN UTERO (468-8376) • fetalsurgery.chop.edu © 2012 The Children’s Hospital of Philadelphia. All Rights Reserved. 5588/1M/02-12