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cardiology

Cardiology

Exercise Testing for Fontan Patients

Cardiologists at Children’s of Alabama are using exercise training to measure Fontan patients’ health.

Children born with single-ventricle heart disease undergo multiple surgeries before age 6, ending with the Fontan procedure, which redirects blood from the inferior and superior vena cava to the pulmonary arteries. This allows blood returning from the body to skip the overworked single ventricle and instead flow directly to the lungs to receive oxygen. While the surgeries have improved survival for these patients, long-term outcomes are still poor. Now, clinicians at Children’s of Alabama are honing in on exercise as an important way to track and improve their quality of life.

“The Fontan operation is one of the most complicated congenital heart procedures we do,” pediatric cardiologist Camden Hebson, M.D., said. “Even with the best outcomes, there’s a shortened lifespan. Many patients start to have major complications by the time they’re in their 20s and 30s, such that it’s pretty unusual for patients to be still living, especially symptom free, in their 50s.”

Camden Hebson, M.D.

The fundamental challenge lies in the procedure’s physiology. In normal hearts, the right side actively pumps blood to the lungs. Because the Fontan operation eliminates this pump, it creates a passive flow system that, while life-sustaining, leads to increased venous pressure throughout the body, particularly in the abdomen and legs.

“The pie in the sky for these patients is getting some sort of pump into them to better push the blood to the lungs,” Hebson said. “There’s all sorts of ideas out there of how to do that, like mechanical implantations and valves. But human beings have our own intrinsic pump that we can maximize: the skeletal muscle pump in our legs, which push venous blood out of the legs back up toward the lungs.”

People who don’t exercise a lot have weak skeletal muscle pumps, he said, which increases the blood pooling and pressure on vital organs, resulting in complications and early mortality. “People who have the strongest legs, the most physically fit legs, the best muscle tone are going to actuate their skeletal muscle pump as much as possible,” he said.

Yet, families and medical teams have traditionally taken a protective approach with these children and limited physical activity, Hebson said. “In some ways, that’s actually a negative, because then these kids are less active than the other kids their age,” he explained. “They exercise less, and then it actually makes the problems of the physiology more likely to occur in their 20s and 30s.”

The link between exercise and better outcomes comes from studies on long-lived Fontan patients called “Super-Fontans.” While the exact reasons for their success aren’t fully understood, physical fitness appears to play a crucial role.

To better understand the effects of exercise on the cardiovascular system of Fontan patients, Hebson and his team use metabolic exercise testing to track heart rate and blood flow during physical activity. This not only helps identify potential treatment targets and provide reassurance about exercise safety, but serves as an early warning sign for complications. For instance, it can reveal issues that aren’t usually apparent at rest, such as the need for stenting the Fontan conduit based on limitations shown in exercise capacity.

“Sometimes, you just need to take the car out on the road and see how it drives,” he said, comparing traditional resting assessments to testing patients during exercise. “For most patients, in particular Fontan patients, your cardiovascular system is what limits your ability to exercise. So how much exercise you can do at any given time is really just feedback on how well the heart works.”

“So we need to encourage our patients to be ahead of the curve on how much exercise they do to keep their legs strong,” Hebson continued. “Not only are they getting the benefits that everybody gets from exercise, they are actually improving the venous return to their heart and their cardiac output as a result.”

“Anything that can be done to improve these patient’s lives and long-term outcomes would be a big deal,” he added.

January 6, 2025 by
Cardiology

Saving lives in Latin America

Each year, a team from Children’s of Alabama travels to Peru to provide cardiovascular surgeries through Heart Care International.

For Children’s of Alabama cardiac pediatric intensivist Santiago Borasino, M.D., traveling to Peru each year as part of a team providing cardiovascular surgeries to children offers him a special way to give back to his home country.

The trips are sponsored by Heart Care International, a nonprofit organization committed to saving the lives of children born with congenital heart defects. Volunteer medical teams come from cardiac centers throughout the United States, including Children’s of Alabama, to provide care throughout Latin America.

Borasino’s first trips were to Chiapas, Mexico, but since he learned about the organization’s work in Peru, he has focused his efforts there.

Santiago Borasino, M.D.

“I get to give back to my country,” he said. “There’s always a lot of guilt for leaving. And so I get to go there, help with surgeries and give back to the country some—a little bit. This teeny tiny bit probably doesn’t repay everything that the country has done for me, but it’s a little bit. It’s very special to me.”

The team—which most recently included Children’s cardiothoracic surgeon Robert Sorabella, M.D.; pediatric cardiac anesthesiologists Jack Crawford, M.D., Ph.D., and Patrick Hussey, M.D.;  and Stephanie McBride, RNFA—works with doctors at the Instituto Nacional de Salud del Niño (INSN) San Borja in Lima, where Borasino was raised and attended medical school.

The local doctors coordinate with the visiting clinicians to choose the cases. “We can’t do cases that are too complex because we don’t have ECMO,” Borasino said. ECMO, or extracorporeal membrane oxygenation, is a life-support machine that can temporarily replace the heart and lungs. They also want the child to be able to recover before the team leaves, so they have to choose wisely, he added.

The visiting team works closely with their Peruvian counterparts. The American and Peruvian surgeons, anesthesiologists and nurses team up for surgeries, while Borasino partners with his Peruvian counterpart to manage the post-operative care side in the ICU. They generally perform about 15 surgeries a day.

Over his six trips to Peru, Borasino has witnessed significant growth in the skills and knowledge of the local medical professionals, most of whom were just starting to practice when he met them. “They’ve grown just like any doctor in the United States grows from being a young doctor who hasn’t done this too much to somebody who’s done it quite a lot.”

“The ultimate goal is that they will be independent,” he said. “They’re never going to be like Americans because of the resources. But, in theory, they could get close, at least for the moderate or low cases, a little complex but not too complex.”

Without these volunteer trips, the outlook for many of the young heart patients is grim. “Some of them will be lucky enough to get surgery within the system,” Borasino said. “And some of them will die. Not immediately, but eventually. Like in a few years without surgery, you end up dying. All these congenital heart diseases eventually kill you, either in weeks, months or years.”

However, the team’s work can be life-changing for the patients they’re able to help.

“The families are so thankful,” Borasino added. “Some come back every year when they know we’re there just to say hi, to bring their kids and tell us, ‘You saved our kid’s life.'” “It’s an opportunity to see more than just cardiac medicine,” he added. “And just to help.”

August 9, 2024 by
Cardiology

Heart team discovers new lung injury biomarker

Ahmed Asfari, M.D., with a patient in the Pediatric & Congenital Heart Center of Alabama at Children’s of Alabama.

Nearly all children who undergo cardiac surgery suffer lung injury afterward, and its treatment can determine whether the injury is short-lived or will follow a child for a lifetime. That’s why the discovery at Children’s of Alabama of a new biomarker to predict which patients are at higher risk of this complication—steering the use of respiratory support—is being heralded as a groundbreaking development that may reap benefits for children far and wide.

Using samples from a Children’s biorepository, heart specialists revealed that blood levels of a protein called proteoglycan 4, commonly known as lubricin, significantly differ between children undergoing long- and short-term mechanical ventilation after cardiac surgery. Until now, physicians haven’t been able to predict which patients stood at higher risk of lung injury in this care setting.

It’s the first time the finding has been reported in the United States, said Ahmed Asfari, M.D., a cardiac intensivist at the Pediatric & Congenital Heart Center of Alabama at Children’s.

“There’s been nothing like this in regards to acute lung injury, especially for our patient population with congenital heart surgery,” said Asfari, who’s also an assistant professor in the Department of Pediatrics and Division of Cardiology at the University of Alabama at Birmingham (UAB). “When we tested the blood of patients with very long mechanical ventilation duration and compared them to patients with short duration, we found the level of this marker goes down, especially within two days of surgery.”

The discovery wouldn’t have been possible without the Children’s biorepository (left), which houses samples dating back over a decade. All patients under age 8 admitted for heart surgery had blood collected at several points in care, including before and after heart and lung bypass treatment, contributing to this research. The findings were validated at the Dr. Tannin Schmidt Lab at the University of Connecticut and published in Translational Pediatrics.

Asfari said the breakthrough likely will change the landscape for children’s care in the future. “Having the ability to have a serum biomarker that we can use to grade the level of acute lung injury will be extremely helpful,” he said.

The next stage of research will also expand insight into how widely the biomarker may be used. Blood testing now includes larger numbers of patients, along with those in different age groups and with varying cardiac physiology and anatomy, as well as those undergoing other types of surgery, and those both on and off bypass.

“The next step of our research will be doing it prospectively, looking at the patients, healthy children, and also patients with acute lung injury with different physiology—not just heart disease—and over a longer period,” Asfari said.

If the results hold, he predicts the new biomarker might one day become a gold-standard test to predict patients’ odds of suffering acute lung injury.

“It has very good potential to be used at bedside,” Asfari said. “This kind of study and research is very important to adjust the care we’ll provide for each individual patient and shines a light on the role of customized medicine for the future.”

January 25, 2024 by
Cardiology

The benefits of bivalirudin during ECMO care

A new study is shaking up the standard practice of using heparin for anticoagulation in ECMO patients.

Anticoagulation therapy during extracorporeal membrane oxygenation (ECMO) has long relied on heparin, but a groundbreaking multicenter study co-authored by Jonathan Byrnes, M.D., medical director of cardiac ECMO at Children’s of Alabama, shows the benefits of replacing heparin with bivalirudin.

Bivalirudin isn’t a new drug, but its rise in use in pediatric ECMO stems from successes in pediatric ventricular assist devices (VADs). With earlier stroke rates as high as 25–30% on VADs using heparin, the transition to bivalirudin brought about a remarkable reduction, dropping the stroke rate to 5–8%. This significant improvement in neurological outcomes sparked interest in applying bivalirudin more extensively in ECMO settings.

The study, spearheaded by Mohammed Hamzah, M.D., of Cleveland Clinic Children’s Hospital, diverged from past practices of individual center decision-making. Instead, six medical centers collaborated, aiming to analyze outcomes through a case-matched lens, minimizing variability across patients requiring ECMO. The study’s cooperative nature across multiple centers necessitated remarkable coordination.

One of the study’s key findings, according to Byrnes, is that patients on bivalirudin exhibited lower mortality rates than those on heparin. Intriguingly, despite higher PTT levels in bivalirudin patients, they experienced less bleeding and fewer thrombotic incidents in the ECMO circuit. This hints at bivalirudin’s inherent benefits, possibly enhancing biocompatibility. “It seems that there’s something intrinsic to bivalirudin that allowed for better biocompatibility of the patient’s blood to the ECMO circuit,” Byrnes said.

The impact of this study extends far beyond the academic realm. At Children’s of Alabama, the findings suggest potential benefits such as reduced bleeding, fewer transfusions and lower mortality rates for ECMO-supported patients. However, as Byrnes noted, the retrospective nature of the study necessitates a randomized controlled trial to solidify these outcomes and effectively influence the standard of care.

Plans for a prospective trial are underway, aiming for a randomized approach coordinated through the Extracorporeal Life Support Organization (ELSO). This prospective study could validate the retrospective findings, potentially reshaping protocols for anticoagulation during ECMO.

Despite the excitement surrounding the study’s outcomes, Byrnes emphasized the need for caution. While retrospective data suggests bivalirudin’s superiority, a randomized trial is crucial to establish this definitively. Prospective data will unveil any center-specific confounders that might have influenced the study’s retrospective findings.

Byrnes underscored the significance of these findings and the hope for future randomized controlled trials. The study’s retrospective nature lays a robust foundation, but prospective data will offer irrefutable evidence to guide clinical practice, leading to a potential paradigm shift in anticoagulation therapy that may result in improved patient care and outcomes.

January 25, 2024 by
Cardiology

Code Committee Brings Innovation and Improvements

HC3 is led by Dr. Ahmed Asfari (top row, fourth from left) and Ashley Moellinger (top row, third from left).

Since the inception of the Heart Center Code Committee (HC3) in 2014, Children’s of Alabama’s cardiac arrest rate in the Cardiovascular ICU has fallen nearly 50%. The impact this committee has had on cardiac arrest reduction has come from numerous quality improvement initiatives and safety changes. In 2022, some of the initiatives Children’s implemented include the development of four guidelines, three communication enhancement tools, checklists and numerous safety changes.

Whenever a patient goes into cardiac arrest or a near miss is encountered, HC3 discusses the case. This multidisciplinary committee is composed of physicians, nurse practitioners, bedside nurses, respiratory therapists, cardiovascular operating room staff, chaplains and leadership from the heart center. HC3 meets every other week to evaluate each case, identify what was done well and areas for improvement.

Nurse practitioner Ashley Moellinger, CRNP, MSHQS, and cardiac intensivist Ahmed Asfari, M.D., who participate in quality improvement initiatives within the heart center, began leading the committee in 2021. They’ve focused on three key areas: education, inclusivity and innovation.

“We have unique patients with really complicated conditions that can be challenging to understand,” Moellinger said. “Whenever we review the event, we look for areas where there’s a knowledge gap or a need to enhance skills.” Then the team sends education briefs to the nurses to highlight committee findings.

Every nurse in the department is involved with the committee. “Really, the committee is owned by the nurses,” Moellinger said. An elite team of nurses reviews each case, interviews those involved and develops a presentation to tell the story of the event. Then, the committee decides together what they need to change. “And that’s where the education rollout comes into play,” Moellinger said.

The committee uses artificial intelligence and near-real-time analytic algorithms to analyze cardiac arrest and near-arrest events. “When you’re talking about a cardiac arrest, everyone’s recollection is going to be different,” Asfari said. With the platform, “we can use objective data to show the patient’s course.” It also allows the team to view vital signs in a continuous manner on one screen.

“One of the things we are most proud of is the ‘green’ epinephrine action plan,” Asfari said. When a patient goes into cardiac arrest, epinephrine is one of the first medications administered, but it takes time to prepare the drug. Shorter time to administer it is associated with better outcomes. The action plan calls for prepared epinephrine at the bedside and includes standing orders for the nurse to administer it once the patient’s vitals reach a certain threshold. “It’s made a huge impact on our patient care,” he said. “Cardiac arrest is a real problem for children with cardiac disease because they are so fragile,” Asfari said. “Improving resuscitation and, more importantly, preventing the arrest can improve the outcome.”

August 22, 2023 by
Cardiology

New Registry Studying Long-Term Outcomes of Heart Procedures

A new national registry is tracking patients’ progress over time following heart procedures as neonates.

Children’s of Alabama has joined a new national registry managed by the Congenital Cardiac Research Collaborative (CCRC), attempting to answer the question: What is the best way to treat ductal-dependent pulmonary blood flow congenital heart conditions?

Conditions such as Tetralogy of Fallot, critical pulmonary valve stenosis and complex single-ventricle arrangements can be treated with various interventions, both percutaneous and surgical. “We’re looking at all neonates (first 30 days of life) who require a procedure, so they get enough pulmonary blood flow to survive,” Children’s pediatric cardiologist Mark Law, M.D., said. “The goal is to take this broad grouping of patients and understand how they do, not just with their first intervention or even their second intervention if they need one, but how do they do as they grow up?” This question of long-term outcomes hasn’t been studied, he said.

“In our field, we tend to be very focused on the short-term, procedural outcome. We have a disease, we have a problem. We do an intervention, and we look at that intervention or outcome. But we haven’t looked at overall survival and longevity; some of the more nuanced outcomes, including quality of life,” Law said.

The idea came about as the result of the Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (COMPASS) trial, which is comparing overall survival and post-surgical complications, hospital length of stay and quality of life between a surgically inserted shunt and one threaded into the ductus arteriosus, the artery that connects the aorta and pulmonary artery in newborns. That trial, in which Children’s is also participating, will follow patients for two years. Part of the funding enabled the development of the registry. Participation requirements for the registry are also broader than for the clinical trial, opening it up to a larger population. It will also be part of Cardiac Networks United, which manages numerous other registries.

The CCRC registry, which currently has 14 participating institutions, started in 2022 and has been collecting data for less than a year. Children’s was among the first institutions to join. The registry will track how patients fare over time and provide valuable information about which treatment pathway is best for which condition and which child. Children’s has been enrolling patients since October 2022 and currently has about 11. The goal is 15 to 20 a year. Registry information on each participant will be updated annually, but Law said that’s one of the challenging parts of the study—for instance, if families move out of the area and are seen at other institutions. That challenge, Law said, could be overcome through the robust electronic health records children’s hospitals use to share information.

August 22, 2023 by
Cardiology

Society of Thoracic Surgeons National Database Reinforces Cardiothoracic Program’s Success

The Children’s of Alabama cardiothoracic surgery program is among the nation’s best in expected-to-observed mortality rate.

A pivotal way to measure a program’s success is by comparing it to others. And according to outcomes recorded in the Society of Thoracic Surgeons (STS) National Database, the Children’s of Alabama cardiothoracic surgery program continues to surpass national trends.

“In 2023, quality is the big catchphrase, but the only way we know we’re providing the best care is to look at results,” Robert Dabal, M.D., chief of pediatric cardiothoracic surgery at Children’s said. “The database allows us to analyze data over lots of different time frames—months or years. It gives us the ability to look at results over time to make sure we’re always improving.”

Established in 1989, the database has become the gold standard for clinical registries, containing data on more than 8.8 million patients and 4,300 surgeons. An important subset is the STS Congenital Heart Surgery Database, which has captured records from more than 600,000 congenital heart surgeries in North America with more than 1,000 physicians. It monitors metrics such as patient complications, reoperations and deaths.

Cardiothoracic surgeons at Children’s perform about 440 congenital heart surgeries each year. The database shows that patients who might not survive in other hospitals are surviving at Children’s, Dabal explained. “Our observed mortality is less than the expected mortality, which is right where we want to be.”

Additionally, the most recent analysis of all pediatric cardiothoracic surgery programs in the Southeast shows Children’s has the second-lowest rates in the region—and one of the lowest rates in the country—in that same expected-to-observed mortality category. Combining the STS data with information culled from several other databases helps provide both a big-picture and granular assessment of Children’s progress and where it may still fall short.

“Perfect is not a realistic goal in medicine, but continually improving your results is an attainable goal,” Dabal said. “That’s why we’re always looking at these results.”

Even the best databases, however, can’t capture all factors related to a program’s success or goals. Along those lines, Dabal hopes future iterations can track young congenital heart patients’ long-term outcomes, not just perioperative data points.

“Most of our patients survive their operation, so the larger pediatric cardiothoracic community is focused on what happens to them one year, five years or 10 years out,” he said. “We want patients to survive surgery, of course, but also to lead normal lives—to go to school, get married and have children of their own. Our bigger focus is looking at the long-term quality of the outcomes we’re providing.”

August 21, 2023 by
Cardiology

Communication, Metrics Drive Quality Improvement in Cardiothoracic Surgery

Ashley Moellinger (left) leads QI projects for the Children’s of Alabama cardiothoracic team.

Two years after launching a quality improvement (QI) project to reduce re-interventions for one of the most complex heart surgeries performed in newborns, the cardiothoracic team at Children’s of Alabama is ready to call it a success.

The project, which is part of the National Pediatric Cardiac Quality Improvement Collaborative, was designed to understand why re-interventions occurred after the Norwood procedure, which involves constructing a new, larger aorta for babies born with hypoplastic left heart syndrome. Patients who don’t require an intervention during the hospitalization after their initial surgery have a mortality rate of about 6% while those who require another surgery or catheterization procedure have a 26% mortality rate.

Children’s slashed its Norwood re-intervention rate and lengths of stay by:

  • Improving communication among team members
  • Identifying and targeting metrics
  • Focusing not on “finger-pointing,” but on how to improve the process

Overall, the unit has seen a 30% reduction in re-intervention in the first phase of the surgery and an 18% drop in the average length of stay, as well as significant improvements in other quality markers, including days to extubation and the use of certain medications like opioids and vasopressors. In addition, interventions for post-operative bleeding fell from 18.5% to 4.2%.

“The two main functional components of what we’re doing are situational awareness and communication,” cardiovascular intensivist Hayden Zaccagni, M.D., said. Together, they allow for more scripted and pinpointed conversations about potential complications, he said. “The communication factor is the most important thing—making sure that all the different disciplines that care for these children have the same kind of knowledge umbrella and communicate about it.”

Also important is having clear expectations about the post-operative period. A high-level map at the bedside clearly shows those metrics on a day-by-day basis for cardiovascular, neurological, respiratory and feeding specialists.

The third piece, according to Ashley Moellinger, RN, CRNP, who co-leads QI initiatives in the department, is holding small group-focused meetings to dissect re-interventions. “We get together those involved and say, ‘How can we prevent this from happening again?’” she said.

As with any QI project, data rules. For instance, one of the most common complications the team saw was post-surgical bleeding, so they developed guidelines to quantify the amount of bleeding in the OR not just in volume, or millimeters, but by measuring the blood coagulopathy, or impaired clotting. That led to the discovery that the lab instrument used for the measurement was outdated. And that, in turn, provided hospital administrators with reason to update the machine because they could see the potential impact on patient outcomes.

While the project is a success based on the numbers, it’s also a success in a less tangible way, Zaccagni said. “The morale of the unit, something we haven’t been able to objectively measure, is also improved.” He thinks it’s due to having a better understanding of where patients have come from medically and where they are now. “There’s this huge sense of collaboration.”  

The team hopes to apply the lessons learned and new systems to other cardiothoracic surgeries.

January 16, 2023 by
Cardiology, Inside Pediatrics

Xenotransplantation Takes Steps Toward Clinical Trials

Children’s of Alabama cardiothoracic surgeon David Cleveland, MD, MBA, leader of the xenotransplantation program at Children’s of Alabama and the University of Alabama at Birmingham (UAB). 

News that surgeons at the University of Maryland Medical Center had implanted a genetically modified pig’s heart into a human rocked the medical world earlier this year. But it didn’t surprise Children’s of Alabama cardiothoracic surgeon David Cleveland, MD, MBA, who is leading a similar xenotransplantation program at Children’s and the University of Alabama at Birmingham (UAB). 

The program focuses on developing genetically modified solid organs from pig models for transplantation. To date, Cleveland’s team has successfully transplanted a genetically modified pig kidney into a brain-dead patient. The kidney produced urine.

Three years ago, Cleveland presented preliminary results from a study showing little reactivity in an infant’s blood to cells from a triple-knockout (TKO) pig. The pig had been genetically modified to delete the three major antigens that react with natural human anti-pig antibodies. Even those human cells that did react demonstrated a very mild reaction.

Back then, Cleveland said the next step was a transplant in a non-human primate, something required before the FDA would approve human trials. 

Now he’s done it. So far, Cleveland and his team have implanted four infant baboons with the genetically modified pig hearts, with one of the animals living as long as eight months. In humans, the goal isn’t to have the heart last a lifetime but, rather, just long enough for a human heart to become available for transplant. 

“I think we have to consistently demonstrate a four-to-six-month survival in non-human primates before the FDA approves a clinical trial,” Cleveland said. The team plans to implant more animals with the hearts this fall and is working on several grants to continue funding the study. Cleveland hopes to be able to submit the design for a clinical trial to the FDA sometime in 2024. In the meantime, he and his team published the results of the first baboon study in The Annals of Thoracic Surgery.

It’s quite possible, however, that the first transplant might occur outside a clinical trial with a humanitarian device exemption from the FDA. The authorization allows a device—in this case, the pig heart—to be used without showing effectiveness in formal clinical trials. That’s how the patient at the University of Maryland Medical Center was able to receive his heart.

“But our goal, ultimately, is to participate in an NIH-funded clinical trial,” Cleveland said, adding that those trials are conducted in more patients with strict safety monitoring and comprehensive data collection.

September 2, 2022 by
Cardiology, Inside Pediatrics

Pea-Sized Device Proves Lifesaving for the Tiniest Babies

Mark Law, MD, and William McMahon, MD, are pediatric cardiologists at Children’s of Alabama.

Imagine a baby who weighs less than two pounds. Now imagine that baby has a life-threatening, congenital heart condition called patent ductus arteriosus (PDA), in which the opening between the two blood vessels leading from the heart hasn’t closed. Now imagine performing open-chest surgery on that tiny neonate. 

“Patent ductus arteriosus is a significant problem for many premature babies,” pediatric cardiologist William S. McMahon, MD, said. Usually, however, it closes on its own. That’s not the case in micropreemies, defined as babies born before the 26th week of pregnancy or weighing less than 28 ounces (700-800 grams). 

PDA affects up to 80% of micropreemies, keeping them on ventilators longer and increasing the risk of lung disease. It can also lead to gastrointestinal problems and affect neurological development. That’s why closing the opening is critical. 

Yet the risks of operating on such a tiny preemie are nearly as great as the risks of PDA, said pediatric cardiologist Mark Law, MD, so few surgeons perform the surgery. 

“It’s a hard decision to make because many babies will survive with the PDA, or it may get smaller,” he said. While there is medication available to treat PDA, it’s often unsuccessful and has its own risk of kidney complications. Still, given the risk of open-chest surgery in such a small baby, “many surgeons would choose to continue to manage the baby medically,” Law said.

That changed in 2019 with the approval of the Amplatzer Piccolo Occluder, a pea-sized device that a cardiologist can snake through the femoral vein and into the heart via a catheter. “With this device, we now have the opportunity to intervene in a minimally invasive fashion with much less insult to the baby and a much lower risk of serious complications and still get the PDA closed,” McMahon said. 

The occluder also allows them to avoid the artery, which they use to close PDAs in full-term or larger premature babies. In such tiny babies, however, putting a catheter through the artery could cause significant damage. “It’s part of the miracle of this device that we don’t have to access the artery,” McMahon said. “It’s much safer going in through the vein.”

Unlike most catheterization procedures, implanting the occlusion device requires a team of specialists, including neonatology, the cardiac catheterization team and anesthesiology, among others. “They’re fragile babies at risk just for the exposure and movement,” Law said. To date, the team has implanted the device in more than 20 babies.

“Not only will the device keep more of these tiny babies alive,” he said, “but, hopefully, it will result in more micropreemies who get to the end of the first year of life with fewer difficulties like chronic lung disease, GI tract disease and neurodevelopmental problems.”

“Any little thing that you can help these babies do better in the first year of life, so they are less dependent on medical technology and even less damaged from the care required to keep them alive,” McMahon said, “ends up in a better baby in the future.”

August 18, 2022 by