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CONGENITAL HEART DISEASE

PATENT DUCTUS ARTERIOSUS (PDA)


A patent ductus arteriosus (PDA) is a blood vessel connecting the aorta with the pulmonary artery. This channel is important prior to birth to allow oxygen-rich blood from the mother to circulate throughout the fetus’s body.

Normally, the vessel closes shortly after birth. If it does not close, oxygen-rich blood can mix with oxygen-poor blood, creating extra work for the heart.

Download the PDA treatment guide to learn more about patent ductus arteriosus (PDA) treatment options.

A PDA IS PRESENT IN APPROXIMATELY 1 IN 2,000 BIRTHS AND IS SIGNIFICANTLY HIGHER IN PRETERM BABIES1

PDAS ACCOUNT FOR APPROXIMATELY 5%-10% OF ALL CONGENITAL HEART DISEASES2

THE FEMALE-TO-MALE RATIO OF PATIENTS WITH PDA IS 2:12

The heart is a pump with four chambers: two small upper chambers called the atria (you have a right and a left atrium) and two larger, more powerful pumping chambers called ventricles (again, you have a right and a left ventricle). A healthy heart pumps blood through the body and is controlled by a unique electrical system embedded within the heart itself. Typically, oxygen-poor blood flows from the body into the heart through the right atrium and then fills the right ventricle. When the heart beats, this blood is pumped through the pulmonary artery out to the lungs to be filtered and receive oxygen. From the lungs, the now oxygen-rich blood enters the heart through the left atrium. It then fills the left ventricle and is pumped through the aorta out to the body to provide oxygen to all the organs and cells. After it circulates throughout the body, it becomes oxygen-poor and returns to the heart.

During fetal development, the heart has two openings that normally close shortly after birth. These openings allow the oxygen-rich blood from the mother to bypass the lungs and flow directly through the fetus’s body. The first opening, called the foramen ovale, is between the left and right atria. The second opening, called the ductus arteriosus, is a channel or pathway connecting the aorta with the pulmonary artery. If these do not close after birth, they are known as patent, or open. If a patent ductus arteriosus is present, additional oxygen-rich blood can pass through the opening and mix with oxygen-poor blood. This causes the heart to overwork.

1
In the baby's heart, the ductus arteriosus remains open while in the womb so a mother’s oxygenated blood can bypass the lungs and flow directly into her child’s heart.
2
For most babies, their ductus arteriosus closes shortly after birth.
3
But in some cases, this hole fails to close and is called a patent ductus arteriosus or PDA. A significant PDA can cause the heart to overwork, can inhibit patient growth, and become life-threatening.
Ductus Arteriosus
Heart Model 2
Normal PDA Closure
Patent Ductus Arteriosus (PDA)

PATENT DUCTUS ARTERIOSUS
SYMPTOMS

Severity of patent ductus arteriosus symptoms often depends on the size of the PDA. Small PDAs may cause no symptoms and are sometimes only detected by the doctor hearing a heart murmur through a stethoscope. Medium to large PDAs may cause fatigue, poor growth and eventually lead to heart failure.2,3 All sizes of PDAs may increase a patient’s risk for a bacterial infection. Symptoms of patent ductus arteriosus may include:

Heart Murmur

HEART
MURMUR

Difficulty in breathing

DIFFICULTY BREATHING

Shortness of Breath

FAST OR HEAVY BREATHING

Poor weight gain

POOR FEEDING AND POOR WEIGHT GAIN (INFANTS)

Sweating or crying while eating

SWEATING WHEN EATING OR CRYING (INFANTS)

PATENT DUCTUS ARTERIOSUS TREATMENT

If you or a loved one has been diagnosed with a patent ductus arteriosus (PDA), it’s important to seek timely treatment since the condition can cause serious complications. Your doctor will discuss the best treatment option for you.

TREATMENT OPTIONS

MAT-2304816 v2.0 | Item approved for U.S. use only.

References
  1. Krasuki RA. Patent ductus arteriosus closure. J Interv Cardiol. 2006;19(5 Suppl):S60-S66. doi: 10.1111/j.1540-8183.2006.00172.x
  2. Schneider DJ, Moore JW. Patent ductus arteriosus. Circulation. 2006;114(17):1873-82. doi: 10.1161/CIRCULATIONAHA.105.592063
  3. Cincinnati Children’s. Congenital patent ductus arteriosus. Accessed March 15, 2023. https://www.cincinnatichildrens.org/health/p/pda. Updated March 2022.
Important Safety Information
  • Amplatzer Piccolo Occluder
  • Amplatzer Duct Occluder
  • Amplatzer Duct Occluder II

  • WHAT IS THE AMPLATZER PICCOLO™
    OCCLUDER APPROVED FOR?
    Available by prescription only.

    The Amplatzer Piccolo™ Occluder is a device that is placed in the heart during a minimally invasive, catheter-based procedure to close a patent ductus arteriosus (PDA).

    WHO SHOULD NOT RECEIVE THE AMPLATZER PICCOLO™ OCCLUDER?

    Patients who weigh less than 700 g or are less than 3 days of age should not receive the Amplatzer Piccolo™ Occluder. Patients who have any of the following conditions should not receive the Amplatzer Piccolo™ Occluder: narrowing of the aorta or of the left pulmonary (lung) artery; high blood pressure in the pulmonary arteries that requires blood flow to the rest of the body to go through the PDA; blood clot in the heart that may interfere with the implant procedure; active infection requiring treatment; PDA length less than 3 mm; PDA diameter at the narrowest portion greater than 4 mm.

    WHAT ARE THE POSSIBLE COMPLICATIONS ASSOCIATED WITH THE AMPLATZER PICCOLO™ OCCLUDER?

    The Piccolo Occluder procedure carries risks which may include, but are not limited to: air bubble that blocks blood flow in a vessel; allergic reaction; low number of red blood cells; anesthesia reaction; temporary pause in breathing; loss of regular heart rhythm; bleeding; perforation of a vessel or the heart; blood or fluid buildup around the heart; chest pain; obstruction of a blood vessel by all or part of an implanted device that entered the bloodstream; device erosion; death; infection or inflammation in the heart; fever; headache or migraine; destruction of red blood cells; collection of blood outside of a blood vessel; high or low blood pressure; infection; heart attack; rapid or irregular beating of the heart; partial obstruction of the aorta or pulmonary (lung) artery; blood clot, including in the leg or lung; fluid buildup around the lung; intervention to remove the device; difficulty breathing; stroke; temporary lack of oxygen to the brain; abnormal backward flow of blood through a valve; injury to the incision site; blockage of a blood vessel.

    WHAT ARE THE WARNINGS ASSOCIATED WITH THE AMPLATZER PICCOLO™ OCCLUDER?

    Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies.

    Talk to your doctor to learn more about the risks associated with the Amplatzer Piccolo™ Occluder.

  • WHAT IS THE AMPLATZER™ DUCT
    OCCLUDER APPROVED FOR?
    Available by prescription only.

    The Amplatzer™ Duct Occluder is a device that is placed in the heart during a minimally invasive, catheter-based procedure to close a patent ductus arteriosus (PDA).

    WHO SHOULD NOT RECEIVE THE AMPLATZER™ DUCT OCCLUDER?

    Patients who weigh less than 6 kg or are less than 6 months of age should not receive the Amplatzer™ Duct Occluder. Patients who have any of the following conditions should not receive the Amplatzer™ Duct Occluder: blood clot at the site of implant in the heart or in the blood vessels used to access the PDA; active heart infection or other infection; veins that are too small for the appropriate sheath size; high blood pressure in the pulmonary (lung) arteries.

    WHAT ARE THE POSSIBLE COMPLICATIONS ASSOCIATED WITH THE AMPLATZER™ DUCT OCCLUDER?

    The Duct Occluder procedure carries risks which may include, but are not limited to: air bubble that blocks blood flow in a vessel; allergic reaction to contrast dye, medication, or anesthesia; temporary pause in breathing; loss of regular heart rhythm; infection or inflammation in the heart; bleeding; weakness, loss of sensation, or loss of movement in the upper arm; chest pain; death; obstruction of a blood vessel by all or part of an implanted device that entered the bloodstream; fever; headache or migraine; high or low blood pressure; heart attack; partial obstruction of the aorta or pulmonary (lung) artery; perforation of a vessel or the heart; blood clot, including in the leg or lung; blood leakage outside a vessel; stroke or temporary lack of oxygen to the brain; abnormal backward flow of blood through a valve; injury to the incision site.

    WHAT ARE THE PRECAUTIONS ASSOCIATED WITH THE AMPLATZER™ DUCT OCCLUDER?

    Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies.

    Talk to your doctor to learn more about the risks associated with the Amplatzer™ Duct Occluder II.

  • WHAT IS THE AMPLATZER™ DUCT
    OCCLUDER II APPROVED FOR?
    Available by prescription only.

    The Amplatzer™ Duct Occluder II is a device that is placed in the heart during a minimally invasive, catheter-based procedure to close a patent ductus arteriosus (PDA).

    WHO SHOULD NOT RECEIVE THE AMPLATZER™ DUCT OCCLUDER II?

    Patients who weigh less than 6 kg or are less than 6 months of age should not receive the Amplatzer™ Duct Occluder II. Patients who have any of the following conditions should not receive the Amplatzer™ Duct Occluder II: PDA length less than 3 mm or greater than 12 mm; PDA diameter greater than 5.5 mm; active infection; blood clot at the site of implant in the heart; high blood pressure in the pulmonary (lung) arteries.

    WHAT ARE THE POSSIBLE COMPLICATIONS ASSOCIATED WITH THE AMPLATZER™ DUCT OCCLUDER II?

    The Duct Occluder II procedure carries risks which may include, but are not limited to: air bubble that blocks blood flow in a vessel; allergic reaction to contrast dye, medication, or anesthesia; temporary pause in breathing; loss of regular heart rhythm; infection or inflammation in the heart; bleeding; perforation of a vessel or the heart; blood or fluid buildup around the heart; chest pain; obstruction of a blood vessel by all or part of an implanted device that entered the bloodstream; device erosion; death; fever; headache or migraine; high or low blood pressure; heart attack; rapid or irregular beating of the heart; fluid buildup around the lung; blood clot, including in the leg or lung; intervention to remove the device; stroke; temporary lack of oxygen to the brain; abnormal backward flow of blood through a valve; injury to the incision site.

    WHAT ARE THE PRECAUTIONS ASSOCIATED WITH THE AMPLATZER™ DUCT OCCLUDER II?

    Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies.

    Talk to your doctor to learn more about the risks associated with the Amplatzer™ Duct Occluder II.

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MAT-2302755 v4.0  |   Item approved for U.S. use only.

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