The PIVOTAL Network is a group of healthcare providers, institutions, and researchers working in collaboration to determine the best approach to treat preterm infants diagnosed with patent ductus arteriosus, commonly referred to as a PDA.
Above: Inside a healthy heart What is a Patent Ductus Arteriosus?
The ductus arteriosus is a blood vessel present in all unborn infants, allowing blood to bypass the lungs while in the womb. The ductus normally closes within a couple of days after birth, after the baby begins to breathe on it’s own. When it does not, it is called a patent ductus arteriosus, and is a congenital heart defect
Above: Inside a heart with patent ductus arteriosus. PDA and Prematurity
Premature infants are more likely to have a PDA than infants born at term. Younger gestational age increases the likelihood of PDA in premature infants. Natural closure of PDA in premature infants may occur, but this may take much longer than normal.
Risks of PDA in Preterm Infants A PDA may cause serious problems, especially for preterm infants:
Difficulty breathing normally Difficulty eating and gaining weight Development of pulmonary hypertension Changes in size, shape, and function of the heart
Treatment of PDA in Preterm Infants Additional Resources National Heart Lung and Blood Institute American Heart Association
In order to allow time for natural closure, doctors may recommend a “wait and see” approach. This is called conservative management. Doctors may recommend procedures to close PDA in premature infants:
Medications to promote closure Catheter-based closure Surgical ligation
Pharmaceutical (Drug) Closure of PDA
Pharmaceutical (Drug) Closure of PDA
Premature infants may be given medications to promote closure of the PDA:
Indomethacin Ibuprofen Acetaminophen
Medications may be tried before any other treatment is recommended
Advantages
Successful in ??% of cases
Risks
Lower gestational age decreases chances of success Reduced blood flow to intestines (side-effect) may lead to gastrointestinal (gut) complications
Conservative Management of PDA
Conservative Management of PDA
During conservative management, the doctors may prescribe
Reduced fluid intake Diuretic medications
Often attempted before more invasive procedures are recommended
Advantages
No procedural intervention(s) High success in higher gestational age premature infants
Risks
Longer duration of exposure to PDA and diuretic medications Restricted weight gain May lead to breathing-related complications if prolonged
Catheter-Based Closure of PDA
Catheter-Based Closure of PDA
This procedure is performed under general anesthesia. A small incision is made in the groin, and a wire (catheter) is inserted into a blood vessel and run up to and into the heart. Using the catheter, a small device is implanted within the PDA to promote clotting and closure.
Advantages
Complete occlusion (closure) of PDA within 24 hours in successful cases Minimally-invasive procedure
Risks
Need for blood transfusion due to blood loss during procedure Embolization (implant migrates from PDA to downstream blood vessel) Anesthesia exposure
Catheter-Based Closure for Premature Infants?
In January of 2019, the US Food and Drug Administration approved a new device for catheter PDA closure. Unlike previous devices, this new occluder was approved for use in preterm infants of 700 grams body weight, or more.
Surgical Ligation of the PDA
Surgical Ligation of the PDA
Surgical ligation is an invasive surgical procedure. An incision is made in the chest, exposing the heart and blood vessels. The PDA is either sewn shut, cut (ligated) and sewn, or a clip (similar to a paperclip) is placed. Often only done when other procedures cannot be used, or fail to close the PDA.
Advantages
Definitive closure of PDA
Risks
Highly invasive procedure Infection at surgical site Vocal cord paralysis (permanent) due to possible nerve damage Post-surgical instability
The PIVOTAL Network is a group of healthcare providers, institutions, and researchers working in collaboration to determine the best approach to treat preterm infants diagnosed with patent ductus arteriosus, commonly referred to as a PDA.
Above: Inside a healthy heart What is a Patent Ductus Arteriosus?
The ductus arteriosus is a blood vessel present in all unborn infants, allowing blood to bypass the lungs while in the womb. The ductus normally closes within a couple of days after birth, after the baby begins to breathe on it’s own. When it does not, it is called a patent ductus arteriosus, and is a congenital heart defect
Above: Inside a heart with patent ductus arteriosus. PDA and Prematurity
Premature infants are more likely to have a PDA than infants born at term. Younger gestational age increases the likelihood of PDA in premature infants. Natural closure of PDA in premature infants may occur, but this may take much longer than normal.
Risks of PDA in Preterm Infants A PDA may cause serious problems, especially for preterm infants:
Difficulty breathing normally Difficulty eating and gaining weight Development of pulmonary hypertension Changes in size, shape, and function of the heart
Treatment of PDA in Preterm Infants Additional Resources National Heart Lung and Blood Institute American Heart Association
In order to allow time for natural closure, doctors may recommend a “wait and see” approach. This is called conservative management. Doctors may recommend procedures to close PDA in premature infants:
Medications to promote closure Catheter-based closure Surgical ligation
Pharmaceutical (Drug) Closure of PDA
Pharmaceutical (Drug) Closure of PDA
Premature infants may be given medications to promote closure of the PDA:
Indomethacin Ibuprofen Acetaminophen
Medications may be tried before any other treatment is recommended
Advantages
Successful in ??% of cases
Risks
Lower gestational age decreases chances of success Reduced blood flow to intestines (side-effect) may lead to gastrointestinal (gut) complications
Conservative Management of PDA
Conservative Management of PDA
During conservative management, the doctors may prescribe
Reduced fluid intake Diuretic medications
Often attempted before more invasive procedures are recommended
Advantages
No procedural intervention(s) High success in higher gestational age premature infants
Risks
Longer duration of exposure to PDA and diuretic medications Restricted weight gain May lead to breathing-related complications if prolonged
Catheter-Based Closure of PDA
Catheter-Based Closure of PDA
This procedure is performed under general anesthesia. A small incision is made in the groin, and a wire (catheter) is inserted into a blood vessel and run up to and into the heart. Using the catheter, a small device is implanted within the PDA to promote clotting and closure.
Advantages
Complete occlusion (closure) of PDA within 24 hours in successful cases Minimally-invasive procedure
Risks
Need for blood transfusion due to blood loss during procedure Embolization (implant migrates from PDA to downstream blood vessel) Anesthesia exposure
Catheter-Based Closure for Premature Infants?
In January of 2019, the US Food and Drug Administration approved a new device for catheter PDA closure. Unlike previous devices, this new occluder was approved for use in preterm infants of 700 grams body weight, or more.
Surgical Ligation of the PDA
Surgical Ligation of the PDA
Surgical ligation is an invasive surgical procedure. An incision is made in the chest, exposing the heart and blood vessels. The PDA is either sewn shut, cut (ligated) and sewn, or a clip (similar to a paperclip) is placed. Often only done when other procedures cannot be used, or fail to close the PDA.
Advantages
Definitive closure of PDA
Risks
Highly invasive procedure Infection at surgical site Vocal cord paralysis (permanent) due to possible nerve damage Post-surgical instability
The PIVOTAL Network is a group of healthcare providers, institutions, and researchers working in collaboration to determine the best approach to treat preterm infants diagnosed with patent ductus arteriosus, commonly referred to as a PDA.
Above: Inside a healthy heart What is a Patent Ductus Arteriosus?
The ductus arteriosus is a blood vessel present in all unborn infants, allowing blood to bypass the lungs while in the womb. The ductus normally closes within a couple of days after birth, after the baby begins to breathe on it’s own. When it does not, it is called a patent ductus arteriosus, and is a congenital heart defect
Above: Inside a heart with patent ductus arteriosus. PDA and Prematurity
Premature infants are more likely to have a PDA than infants born at term. Younger gestational age increases the likelihood of PDA in premature infants. Natural closure of PDA in premature infants may occur, but this may take much longer than normal.
Risks of PDA in Preterm Infants A PDA may cause serious problems, especially for preterm infants:
Difficulty breathing normally Difficulty eating and gaining weight Development of pulmonary hypertension Changes in size, shape, and function of the heart
The PIVOTAL Network is a group of healthcare providers, institutions, and researchers working in collaboration to determine the best approach to treat preterm infants diagnosed with patent ductus arteriosus, commonly referred to as a PDA.
Above: Inside a healthy heart
What is a Patent Ductus Arteriosus?
- The ductus arteriosus is a blood vessel present in all unborn infants, allowing blood to bypass the lungs while in the womb.
- The ductus normally closes within a couple of days after birth, after the baby begins to breathe on it’s own.
- When it does not, it is called a patent ductus arteriosus, and is a congenital heart defect
Above: Inside a heart with patent ductus arteriosus.
PDA and Prematurity
- Premature infants are more likely to have a PDA than infants born at term.
- Younger gestational age increases the likelihood of PDA in premature infants.
- Natural closure of PDA in premature infants may occur, but this may take much longer than normal.
Risks of PDA in Preterm Infants
A PDA may cause serious problems, especially for preterm infants:
- Difficulty breathing normally
- Difficulty eating and gaining weight
- Development of pulmonary hypertension
- Changes in size, shape, and function of the heart
Treatment of PDA in Preterm Infants Additional Resources National Heart Lung and Blood Institute American Heart Association
In order to allow time for natural closure, doctors may recommend a “wait and see” approach. This is called conservative management. Doctors may recommend procedures to close PDA in premature infants:
Medications to promote closure Catheter-based closure Surgical ligation
Treatment of PDA in Preterm Infants Additional Resources National Heart Lung and Blood Institute American Heart Association
In order to allow time for natural closure, doctors may recommend a “wait and see” approach. This is called conservative management. Doctors may recommend procedures to close PDA in premature infants:
Medications to promote closure Catheter-based closure Surgical ligation
Treatment of PDA in Preterm Infants
- In order to allow time for natural closure, doctors may recommend a “wait and see” approach. This is called conservative management.
- Doctors may recommend procedures to close PDA in premature infants:
- Medications to promote closure
- Catheter-based closure
- Surgical ligation
Additional Resources
National Heart Lung and Blood Institute
American Heart Association
- Medications to promote closure
- Catheter-based closure
- Surgical ligation
Pharmaceutical (Drug) Closure of PDA
Pharmaceutical (Drug) Closure of PDA
Premature infants may be given medications to promote closure of the PDA:
Indomethacin Ibuprofen Acetaminophen
Medications may be tried before any other treatment is recommended
Advantages
Successful in ??% of cases
Risks
Lower gestational age decreases chances of success Reduced blood flow to intestines (side-effect) may lead to gastrointestinal (gut) complications
Conservative Management of PDA
Conservative Management of PDA
During conservative management, the doctors may prescribe
Reduced fluid intake Diuretic medications
Often attempted before more invasive procedures are recommended
Advantages
No procedural intervention(s) High success in higher gestational age premature infants
Risks
Longer duration of exposure to PDA and diuretic medications Restricted weight gain May lead to breathing-related complications if prolonged
Catheter-Based Closure of PDA
Catheter-Based Closure of PDA
This procedure is performed under general anesthesia. A small incision is made in the groin, and a wire (catheter) is inserted into a blood vessel and run up to and into the heart. Using the catheter, a small device is implanted within the PDA to promote clotting and closure.
Advantages
Complete occlusion (closure) of PDA within 24 hours in successful cases Minimally-invasive procedure
Risks
Need for blood transfusion due to blood loss during procedure Embolization (implant migrates from PDA to downstream blood vessel) Anesthesia exposure
Catheter-Based Closure for Premature Infants?
In January of 2019, the US Food and Drug Administration approved a new device for catheter PDA closure. Unlike previous devices, this new occluder was approved for use in preterm infants of 700 grams body weight, or more.
Surgical Ligation of the PDA
Surgical Ligation of the PDA
Surgical ligation is an invasive surgical procedure. An incision is made in the chest, exposing the heart and blood vessels. The PDA is either sewn shut, cut (ligated) and sewn, or a clip (similar to a paperclip) is placed. Often only done when other procedures cannot be used, or fail to close the PDA.
Advantages
Definitive closure of PDA
Risks
Highly invasive procedure Infection at surgical site Vocal cord paralysis (permanent) due to possible nerve damage Post-surgical instability
Pharmaceutical (Drug) Closure of PDA
Pharmaceutical (Drug) Closure of PDA
Premature infants may be given medications to promote closure of the PDA:
Indomethacin Ibuprofen Acetaminophen
Medications may be tried before any other treatment is recommended
Advantages
Successful in ??% of cases
Risks
Lower gestational age decreases chances of success Reduced blood flow to intestines (side-effect) may lead to gastrointestinal (gut) complications
Conservative Management of PDA
Conservative Management of PDA
During conservative management, the doctors may prescribe
Reduced fluid intake Diuretic medications
Often attempted before more invasive procedures are recommended
Advantages
No procedural intervention(s) High success in higher gestational age premature infants
Risks
Longer duration of exposure to PDA and diuretic medications Restricted weight gain May lead to breathing-related complications if prolonged
Catheter-Based Closure of PDA
Catheter-Based Closure of PDA
This procedure is performed under general anesthesia. A small incision is made in the groin, and a wire (catheter) is inserted into a blood vessel and run up to and into the heart. Using the catheter, a small device is implanted within the PDA to promote clotting and closure.
Advantages
Complete occlusion (closure) of PDA within 24 hours in successful cases Minimally-invasive procedure
Risks
Need for blood transfusion due to blood loss during procedure Embolization (implant migrates from PDA to downstream blood vessel) Anesthesia exposure
Catheter-Based Closure for Premature Infants?
In January of 2019, the US Food and Drug Administration approved a new device for catheter PDA closure. Unlike previous devices, this new occluder was approved for use in preterm infants of 700 grams body weight, or more.
Surgical Ligation of the PDA
Surgical Ligation of the PDA
Surgical ligation is an invasive surgical procedure. An incision is made in the chest, exposing the heart and blood vessels. The PDA is either sewn shut, cut (ligated) and sewn, or a clip (similar to a paperclip) is placed. Often only done when other procedures cannot be used, or fail to close the PDA.
Advantages
Definitive closure of PDA
Risks
Highly invasive procedure Infection at surgical site Vocal cord paralysis (permanent) due to possible nerve damage Post-surgical instability
Pharmaceutical (Drug) Closure of PDA
Pharmaceutical (Drug) Closure of PDA
Premature infants may be given medications to promote closure of the PDA:
Indomethacin Ibuprofen Acetaminophen
Medications may be tried before any other treatment is recommended
Advantages
Successful in ??% of cases
Risks
Lower gestational age decreases chances of success Reduced blood flow to intestines (side-effect) may lead to gastrointestinal (gut) complications
Conservative Management of PDA
Conservative Management of PDA
During conservative management, the doctors may prescribe
Reduced fluid intake Diuretic medications
Often attempted before more invasive procedures are recommended
Advantages
No procedural intervention(s) High success in higher gestational age premature infants
Risks
Longer duration of exposure to PDA and diuretic medications Restricted weight gain May lead to breathing-related complications if prolonged
Catheter-Based Closure of PDA
Catheter-Based Closure of PDA
This procedure is performed under general anesthesia. A small incision is made in the groin, and a wire (catheter) is inserted into a blood vessel and run up to and into the heart. Using the catheter, a small device is implanted within the PDA to promote clotting and closure.
Advantages
Complete occlusion (closure) of PDA within 24 hours in successful cases Minimally-invasive procedure
Risks
Need for blood transfusion due to blood loss during procedure Embolization (implant migrates from PDA to downstream blood vessel) Anesthesia exposure
Catheter-Based Closure for Premature Infants?
In January of 2019, the US Food and Drug Administration approved a new device for catheter PDA closure. Unlike previous devices, this new occluder was approved for use in preterm infants of 700 grams body weight, or more.
Surgical Ligation of the PDA
Surgical Ligation of the PDA
Surgical ligation is an invasive surgical procedure. An incision is made in the chest, exposing the heart and blood vessels. The PDA is either sewn shut, cut (ligated) and sewn, or a clip (similar to a paperclip) is placed. Often only done when other procedures cannot be used, or fail to close the PDA.
Advantages
Definitive closure of PDA
Risks
Highly invasive procedure Infection at surgical site Vocal cord paralysis (permanent) due to possible nerve damage Post-surgical instability
Pharmaceutical (Drug) Closure of PDA
Premature infants may be given medications to promote closure of the PDA:
Indomethacin Ibuprofen Acetaminophen
Medications may be tried before any other treatment is recommended
Advantages
Successful in ??% of cases
Risks
Lower gestational age decreases chances of success Reduced blood flow to intestines (side-effect) may lead to gastrointestinal (gut) complications
Pharmaceutical (Drug) Closure of PDA
- Premature infants may be given medications to promote closure of the PDA:
- Indomethacin
- Ibuprofen
- Acetaminophen
- Medications may be tried before any other treatment is recommended
Advantages
- Successful in ??% of cases
Risks
Lower gestational age decreases chances of success
Reduced blood flow to intestines (side-effect) may lead to gastrointestinal (gut) complications
Indomethacin
Ibuprofen
Acetaminophen
Conservative Management of PDA
During conservative management, the doctors may prescribe
Reduced fluid intake Diuretic medications
Often attempted before more invasive procedures are recommended
Advantages
No procedural intervention(s) High success in higher gestational age premature infants
Risks
Longer duration of exposure to PDA and diuretic medications Restricted weight gain May lead to breathing-related complications if prolonged
Conservative Management of PDA
During conservative management, the doctors may prescribe
Reduced fluid intake
Diuretic medications
Often attempted before more invasive procedures are recommended
No procedural intervention(s)
High success in higher gestational age premature infants
Longer duration of exposure to PDA and diuretic medications
Restricted weight gain
May lead to breathing-related complications if prolonged
Reduced fluid intake
Diuretic medications
Catheter-Based Closure of PDA
This procedure is performed under general anesthesia. A small incision is made in the groin, and a wire (catheter) is inserted into a blood vessel and run up to and into the heart. Using the catheter, a small device is implanted within the PDA to promote clotting and closure.
Advantages
Complete occlusion (closure) of PDA within 24 hours in successful cases Minimally-invasive procedure
Risks
Need for blood transfusion due to blood loss during procedure Embolization (implant migrates from PDA to downstream blood vessel) Anesthesia exposure
Catheter-Based Closure for Premature Infants?
In January of 2019, the US Food and Drug Administration approved a new device for catheter PDA closure. Unlike previous devices, this new occluder was approved for use in preterm infants of 700 grams body weight, or more.
Catheter-Based Closure of PDA
This procedure is performed under general anesthesia.
A small incision is made in the groin, and a wire (catheter) is inserted into a blood vessel and run up to and into the heart.
Using the catheter, a small device is implanted within the PDA to promote clotting and closure.
Complete occlusion (closure) of PDA within 24 hours in successful cases
Minimally-invasive procedure
Need for blood transfusion due to blood loss during procedure
Embolization (implant migrates from PDA to downstream blood vessel)
Anesthesia exposure
Catheter-Based Closure for Premature Infants?
- In January of 2019, the US Food and Drug Administration approved a new device for catheter PDA closure.
- Unlike previous devices, this new occluder was approved for use in preterm infants of 700 grams body weight, or more.
Surgical Ligation of the PDA
Surgical ligation is an invasive surgical procedure. An incision is made in the chest, exposing the heart and blood vessels. The PDA is either sewn shut, cut (ligated) and sewn, or a clip (similar to a paperclip) is placed. Often only done when other procedures cannot be used, or fail to close the PDA.
Advantages
Definitive closure of PDA
Risks
Highly invasive procedure Infection at surgical site Vocal cord paralysis (permanent) due to possible nerve damage Post-surgical instability
Surgical Ligation of the PDA
Surgical ligation is an invasive surgical procedure.
An incision is made in the chest, exposing the heart and blood vessels.
The PDA is either sewn shut, cut (ligated) and sewn, or a clip (similar to a paperclip) is placed.
Often only done when other procedures cannot be used, or fail to close the PDA.
Definitive closure of PDA
Highly invasive procedure
Infection at surgical site
Vocal cord paralysis (permanent) due to possible nerve damage
Post-surgical instability
