Los Angeles Doctors Perform Rare Fetal Cardiac Procedure for First Time in Southern California

Doctors Insert Tiny Device in Fetal Heart to Normalize Blood Flow and
Strengthen Newborn for Open-Heart Surgery After Birth

LOS ANGELES–(BUSINESS WIRE)–Last August, when Children’s
Hospital Los Angeles
(CHLA) cardiologists confirmed that the heart
of a 27-week-old fetus suffered from a critical cardiac condition that
prevented blood returning from the fetus’s lungs from circulating back
into the body, they told the parents that their child faced certain
open-heart surgery after birth. Even worse, babies born with this very
rare condition—hypoplastic left heart syndrome (HLHS) with restrictive
atrial septum—have a 50 percent neonatal mortality rate.

But thanks to the expertise available at CHLA, the Davilas had another
option—having their unborn child (now delivered and named Grayson)
undergo a fetal cardiac intervention procedure in utero that would
increase the odds of the child’s survival when the open-heart surgery
took place. The procedure would be coordinated by fetal therapy
specialists from the CHLA-USC
Institute for Maternal-Fetal Health
, a medical team unlike any other
in Southern California.

If all went well, Grayson would survive and undergo open-heart surgery
performed by CHLA’s renowned heart surgery team, led by cardiothoracic
surgeon Vaughn
, MD, co-director of the CHLA Heart

“CHLA was the only institution I could find on the West Coast that
offered my child the access to premium, state-of-the-art facilities and
great care before and after his birth,” says Grayson’s father, Marco
Davila, a technology director at a semiconductor company.

On Sept. 9, the physicians gathered at CHA Hollywood Presbyterian
Medical Center to perform what cardiologists describe as an “in utero
atrial septal stent procedure” to open the atrium, allowing blood
trapped in the lungs and left upper heart chamber of a HLHS fetus to
flow back to the right side of the heart. The successful procedure was a
first for the Institute for Maternal-Fetal Health and a first for a
Southern California hospital.

The fetal interventionalist conducting the procedure was Ramen
, MD, director of Los Angeles Fetal Surgery, a branch of the
CHLA-USC Institute for Maternal-Fetal Health. Chmait guided a thin
needle into the mother’s womb and into the heart of the fetus. Pediatric
interventional cardiologist Frank
, MD, co-director of the CHLA Heart Institute, then deployed a
stent device in the developing child’s heart. Ultrasound guidance (fetal
echocardiogram) provided by CHLA fetal cardiologist Jay
, MD, showed the way for both physicians.

“The work by the team demonstrated the state-of-the-art prenatal
diagnosis and fetal heart therapy technology, based on a
multi-disciplinary approach, available for fetuses with severe
congenital heart defects,” says Ing, chief of the Division
of Cardiology
at CHLA. “We demonstrated that in utero procedures can
ultimately alter the natural history and postnatal health outcomes to
increase a child’s odds for survival. This expertise was brought
together by a vision to provide these specialized interventions and top
surgical care as no other institution can in Southern California.”

“Completing this highly specialized fetal intervention procedure
contributed to Grayson’s ability to survive after his birth,” says
Chmait, associate professor of Clinical Obstetrics and Gynecology at the
Keck School of Medicine of the University of Southern California. “It
successfully strengthened his lungs so the surgeons could do their job
after he was born.”

Everything about the procedure required special preparation. Incredibly
small fetal microsurgery tools, including a 12-centimeter metal needle,
and a tiny transcatheter metal stent that inflates to 2.8 millimeters
across the atrial septum, were used to perform the procedure. The
mother, Samantha Davila, received local anesthesia. The baby was
anesthetized in the womb so there would be no ill-timed movements as the
doctors worked.

Chmait used a thin (18-gauge) metal needle, called a cannula, to
penetrate the mom’s stomach, guiding it into her uterus, through the
amniotic cavity and into the fetus’s torso. The cannula was carefully
finessed into the fetus’s heart (which is about the size of a small
walnut), puncturing the atrial septum with the needle tip inside the
fetus’s left atrium.

With the cannula stationed across the atrial septum, Ing then threaded a
hair-thin wire (0.014 inches) down through the tube, the wire acting as
a rail for Ing to gently maneuver a tiny, 8-millimeter-long stent across
the septum. Ing mounted the stent onto a balloon catheter for delivery
and used a predetermined amount of pressure to inflate the delivery
balloon and expand the stent to open a pathway in the atrial septum. The
team of doctors determined the stent was in good position by ultrasound
imaging, and then deployed it by inflating the balloon catheter.

Once the stent was confirmed to be functioning, the balloon catheter was
deflated and everything was removed from the baby and the mother,
including the wire and needle. The stent remained in the heart to allow
blood flow out of the left upper chamber, across the atrial septum, and
back into circulation in the right side of the heart. The procedure
itself took about 15 minutes once the fetus was in place. After 30
additional minutes of monitoring, the procedure was concluded.

During the remainder of the pregnancy, Samantha, a program manager at an
aerospace and defense company, was followed closely to ensure that the
atrial stent was functioning well. The stent held up until the late
third trimester, when it appeared to close down, providing little to no
flow between the fetus’s upper heart chambers, Pruetz says. But in the
interim, the lungs had been given time to strengthen and develop during
a critical time window of gestation. Ten weeks after the stent
procedure, mom Samantha gave birth via a planned cesarean section at
Hollywood Presbyterian. Grayson was born on Nov. 19 at 8:29 a.m.

Following Grayson’s delivery, the closure of the atrial septum in
Grayson’s heart prevented the lungs from delivering enough oxygenated
blood back to his body. Consequently, Grayson was immediately
transported next door to CHLA. There, a pediatric cardiothoracic surgery
team was standing by to perform a full Norwood surgery, led by Starnes.
Starnes began the operation just 90 minutes after birth, which is
uncommon but was determined to be safe for Grayson because the stent
procedure had successfully promoted lung development, enabling him to
survive the invasive operation.

The Norwood surgery uses the right heart and pulmonary artery to become
the main pathway for pumping blood to the body. Starnes removed the
stent from Grayson’s heart and also performed a Sano modification using
a tube to connect the right ventricle to the pulmonary artery as part of
the Norwood procedure. “We were able to operate quickly because we were
aware of his condition and Grayson’s lungs were strong enough,” Starnes
explains. “This coordination of care between the fetal therapy team and
CHLA surgeons was extraordinary, starting with the transcatheter fetal
cardiac procedure, the monitoring during the pregnancy leading up to the
birth, and the surgery.”

Grayson was discharged from CHLA on Dec. 14 and went home with his
thrilled parents. “The health outcomes for children who receive the
Norwood procedure at CHLA are considerably higher than the national
average,” Starnes says. Grayson still has two additional heart surgeries
ahead, the Glenn and the Fontan, procedures that route oxygen–poor blood
directly to the lungs, leaving the right ventricle employed as the
heart’s primary pumping chamber. Those operations will take place over
the next six months and at 3 years of age, respectively.

About Children’s Hospital Los Angeles

Children’s Hospital Los Angeles has been named the best children’s
hospital in California and among the top 10 in the nation for clinical
excellence with its selection to the prestigious US News & World
Report Honor Roll
. Children’s Hospital is home to The Saban Research
Institute, one of the largest and most productive pediatric research
facilities in the United States. The hospital is also one of America’s
premier teaching hospitals through its affiliation since 1932 with the
Keck School of Medicine of the University of Southern California.

For more information, visit www.CHLA.org.
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CHLA Media Relations
Lorenzo Benet