Filling a Big Need Among Smallest of Us

With Abbott's Amplatzer Piccolo Occluder, preemie babies’ hearts with PDA defect can now get help they need.

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Products and Innovation | Feb. 1, 2019

When Irie Felkner and her twin brother Judah were born prematurely at 27 weeks, their parents knew the first few months wouldn’t be easy.

While the twins were fighting for their lives in the neonatal intensive care unit (NICU), hooked up on ventilators, an echocardiogram showed an opening in Irie’s heart had grown too large.

Irie was suffering from a life-threatening congenital defect called a patent ductus arteriosus, or PDA, which is an opening between two blood vessels leading from the heart that is also present in normally developing fetuses. For most babies, that opening seals itself shortly after birth.

But in some cases — primarily in premature babies such as Irie — it fails to close, making it difficult for babies to breathe normally due to an increased flow of blood to the lungs.

“One of the nurses mentioned that she heard a heart murmur and said that Irie had a PDA. I said, ‘Wait. What are you talking about? What's a PDA?’ ” said Crissa, Irie’s mother.

Irie was one of the nearly 12,000 premature babies each year in the U.S. with a PDA requiring urgent treatment to survive. 1 2

“We saw that Irie’s heart was enlarging in size and more and more fluid was collecting in her lungs,” said Aimee Armstrong, MD, director of Cardiac Catheterization and Interventional Therapies at Nationwide Children’s Hospital, and Irie’s cardiologist.

Dr. Armstrong suggested Irie may be a candidate for a clinical trial for the world’s first minimally invasive closure device specifically designed for preemies and newborns to correct PDA without the need for open-heart surgery. Nationwide Children’s Hospital was one of eight centers participating in the trial.

With Abbott’s Amplatzer Piccolo™ Occluder, Irie’s procedure successfully closed her PDA.

After the procedure, Irie was able to breathe on her own within three days and was taken off the ventilator. And after spending 90 days at Nationwide Children’s Hospital, Irie went home, where she is growing and thriving.

"You have to live it to fully appreciate what that device did for our daughter,” said Matt, Irie’s dad. “Three days after the procedure, she was making great progress.”

Today, Irie is a typical toddler, always on the move alongside her twin brother. She enjoys her toys and nature walks with her family to get up close with animals. Irie loves to dance and being held upside down. Her parents predict that she might be a future gymnast.

“Irie’s heart disease is gone. Her PDA is gone. She has no narrowings or any issues in the heart, and she will not need to be followed long term because of the PDA,” said Dr. Armstrong. “Her prognosis is outstanding.”

“I would definitely consider Abbott’s Piccolo device to be Irie's lifesaver,” Crissa said. “If it wasn't for the procedure, we might still be in the hospital.”

AMPLATZER PICCOLO OCCLUDER IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

The AMPLATZER PiccoloTM Occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (PDA).

CONTRAINDICATIONS

• Weight < 700 grams at time of the procedure

• Age < 3 days at time of procedure

• Coarctation of the aorta

• Left pulmonary artery stenosis

• Cardiac output that is dependent on right to left shunt through the PDA due to pulmonary hypertension

• Intracardiac thrombus that may interfere with the implant procedure

• Active infection requiring treatment at the time of implant

• Patients with a PDA length smaller than 3 mm

• Patients with a PDA diameter that is greater than

4 mm at the narrowest portion

WARNINGS

• This device was sterilized with ethylene oxide and is for single use only. Do not reuse or re-sterilize this device. Attempts to resterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.

• Do not use the device if the sterile package is open or damaged.

• Use on or before the last day of the expiration month that is printed on the product packaging label.

• Patients who are allergic to nickel can have an allergic reaction to this device.

• Prepare for situations that require the removal of this device. Preparation includes access to a transcatheter snare kit and an on-site surgeon.

• Accurate measurements of the ductus are crucial for correct occluder size selection.

• Do not release the occluder from the delivery wire if either a retention disc protrudes into the pulmonary artery or aorta; or if the position of the occluder is not stable.

• Remove embolized devices. Do not remove

an embolized occluder through intracardiac structures unless the occluder is fully recaptured inside a catheter.

PRECAUTIONS

• This device should be used only by physicians who are trained in standard transcatheter techniques. Determine which patients are candidates for procedures that use this device.

• The physician should exercise clinical judgment in situations that involve the use of anticoagulants and antiplatelet drugs before, during, and/or after the use of this device.

• Patients should have an activated clotting time (ACT) of greater than 200 sec prior to device placement, unless the patient has a significant risk for bleeding and is unable to be anti-coagulated.

• The device may be delivered via an anterograde (venous) or a retrograde (arterial) approach. However, in small infants (≤2 kg), the device should be delivered using the anterograde (venous) approach since small infants are at an increased risk for arterial injury.

• The AMPLATZER PiccoloTM Occluder contains nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 60 days following implant. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should seek immediate medical attention if there is suspicion of an allergic reaction. Symptoms may include difficulty in breathing or swelling of the face or throat. While data are currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted.

• Use in specific populations

n Pregnancy — Minimize radiation exposure to the

fetus and the mother.

n Nursing mothers — There has been no quantitative assessment for the presence of leachables in breast milk.

• Store in a dry place.

• Do not use contrast power injection with

delivery catheter.

POTENTIAL ADVERSE EVENTS

Potential adverse events that may occur during or after a procedure placing this device include, but are not limited to:

• Air embolus

• Allergic dye reaction

• Allergic drug reaction

• Anesthesia reactions

• Apnea

• Arrhythmia

• Bacterial endocarditis

• Bleeding

• Cardiac perforation

• Cardiac tamponade

• Chest pain

• Device embolization

• Device erosion

• Death

• Fever

• Headache/migraine

• Hemolysis

• Hematoma

• Hypertension

• Hypotension

• Infection

• Myocardial infarction

• Palpitations

• Partial obstruction of aorta

• Partial obstruction of pulmonary artery • Pericardial effusion

• Pericarditis

• Peripheral embolism

• Pleural effusion

• Pulmonary embolism

• Re-intervention for device removal

• Respiratory distress

• Stroke

• Thrombus

• Transient ischemic attack

• Valvular regurgitation

• Vascular access site injury

• Vascular occlusion

• Vessel perforation

This testimonial relates an account of an individual’s response to the treatment. This patient’s account is genuine, typical and documented. However, it does not provide any indication, guide, warranty or guarantee as to the response other persons may have to the treatment. Responses to the treatment discussed can and do vary and are specific to the individual patient.

References

1Tashiro, Jun, Bo Wang, Juan E. Sola, Anthony R. Hogan, Holly L. Neville, and Eduardo A. Perez. "Patent ductus arteriosus ligation in premature infants in the United States." journal of surgical research 190, no. 2 (2014): 613-622.
2Bonamy, Anna-Karin Edstedt, Anna Gudmundsdottir, Rolf F. Maier, Liis Toome, Jennifer Zeitlin, Mercedes Bonet, Alan Fenton et al. "Patent ductus arteriosus treatment in very preterm infants: a european population-based cohort study (EPICE) on variation and outcomes." Neonatology 111, no. 4 (2017): 367-375.