Team Brings Piccolo PDA Closure to the Bedside

Since its approval in 2019, the Amplatzer Piccolo Occluder has been a game-changer—allowing teams to close a patent ductus arteriosus (PDA) in premature babies in a minimally invasive way.

But there’s one problem: Some babies are too sick to be moved to a catheterization lab for the procedure.

Now, a new protocol at Children’s Hospital Los Angeles is allowing patients to receive the device at the bedside—without ever leaving their room in the Steven & Alexandra Cohen Foundation Newborn and Infant Critical Care Unit (NICCU).

“It’s much better and safer for the babies to keep them at the bedside,” says Patrick Sullivan, MD, an interventional cardiologist in the Heart Institute at CHLA. “Instead of bringing babies to the Cath Lab, we bring the Cath Lab to the NICCU.”

Keys to success

Many babies who need PDA closure are extremely premature, with a gestational age as young as 22 weeks. Although some are more fragile than others, all have special needs.

“It’s critical to keep their temperature and ventilator settings stable,” explains Jennifer Shepherd, MD, a neonatologist in CHLA’s Fetal and Neonatal Institute. “Any small stress or movements—such as transporting a baby down several long hallways and riding in an elevator to and from the Cath Lab—can put them at risk for a brain bleed or losing their endotracheal tube or IV lines.”

Drs. Sullivan and Shepherd led a multidisciplinary team that developed a way to safely bring the intricate Piccolo procedure to a baby’s bedside. The team also involved Darren Berman, MD, Shahab Noori, MD, MS, Rachel Chapman, MD, pediatric cardiac anesthesiologists, sonographers, echocardiography specialists, Cath Lab techs, neonatal nurses, respiratory therapists and more.

The CHLA protocol includes several key elements:

• Mobile imaging. X-ray video guidance is critical for the safety and success of the procedure. To replicate this imaging at the bedside, the team brings a portable mini C-arm X-ray machine into the NICCU. The machines were already available in the hospital because they are used by various surgical teams.

• Special procedure table. Because the NICCU beds contain metal, the C-arm X-ray machine cannot be used directly on the isolette. Instead, the team uses a special procedure table previously used by the Interventional Radiology group.

  The team will soon begin using a portable fluoroscopy machine that fits directly in the NICCU isolettes. This machine will replace the mini C-arm X-ray and allow babies to stay in their isolettes.

• The right room. Larger, double rooms more easily fit all the needed equipment and team members. The NICCU staff ensures that babies who may need PDA closure are placed in these larger rooms as soon as they arrive at the hospital. This eliminates the need to change rooms later.
• Temperature control. The room is kept at a balmy 80 degrees during the procedure to keep the baby’s temperature stable.

‘A huge benefit’

The team performed its first bedside Piccolo PDA closure in July. It has now completed 10 of these closures in the NICCU, and all have gone smoothly.

“Every Piccolo procedure is now done at the bedside,” Dr. Sullivan says. “We have become very comfortable with this setup, very quickly. It’s been a tremendous effort that has involved our entire Heart Institute and NICCU teams.”

Keeping babies in the NICCU also means that neonatologists and other specialists are nearby if needed, Dr. Shepherd adds.

“It was initially a challenge to accommodate the Cath Lab equipment and personnel,” she notes. “But it’s turned into a huge benefit. We don’t have to move the baby, and all our NICCU resources—from neonatologists to nurses to respiratory therapists—are readily available.”

Children’s Hospital Los Angeles is also participating in a multicenter randomized clinical trial that is comparing Piccolo PDA closure to conservative management.

An open ductus can result in too much blood flow to the lungs, leading to heart failure and increasing the need for ventilatory support. Still, PDA closure has been controversial among neonatologists—largely because traditional surgical approaches created significant stress for babies.

“We believe that closing the PDA in a minimally invasive way—and without the risks of transporting the patient—most likely benefits the baby,” says Dr. Sullivan. “This trial will help answer that important question. We are excited to participate in these studies and to offer the least invasive options for these fragile babies.”