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cardiovascular services

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 childrensal

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 childrensal

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 childrensal

Cardiology, Inside Pediatrics

Harmony Device Saves Children from Open-Heart Surgery

In July 2021, interventional cardiologist William McMahon, M.D., Mark Law, M.D., and the Pediatric Cardiac Catheterization Lab team at Children’s of Alabama, snaked a catheter device through a vein in a 16-year-old girl’s leg up to her heart and replaced the valve. She went home the next day with just a small scar on her leg that will eventually become invisible. The U.S. Food and Drug Administration approved the device, called the Harmony transcatheter pulmonary valve, in March. Drs. McMahon and Law were the first cardiology specialists in a 10-state region to use it.

Fewer than 20,000 children are born each year with Tetralogy of Fallot, a condition marked by four major heart defects: ventricular septal defect, or a hole in the two lower chambers of the heart; a narrowing of the pulmonary valve and main pulmonary artery; malaligned aortic valve; and ventricular hypertrophy, or thickening, of the right ventricle. These children often need surgery soon after birth and a pulmonary valve replacement by the time they’re adolescents or young adults.

In the past, that meant another open-heart surgery and time spent on cardiopulmonary bypass, which carries significant risks of complications; a week or more in the hospital; scarring; weeks of recovery at home; and a low but real risk of death. In addition, because the children have already had major heart surgery, scar tissue from the previous procedure makes the valve replacement even more difficult.

In July 2021, however, interventional cardiologist William McMahon, M.D., and his colleague Mark Law, M.D., together with the Pediatric Cardiac Catheterization Lab team at Children’s of Alabama, snaked a catheter device through a vein in a 16-year-old girl’s leg up to her heart and replaced the valve. She went home the next day with just a small scar on her leg that will eventually become invisible.

The U.S. Food and Drug Administration had just approved the device, called the Harmony transcatheter pulmonary valve, in March. Drs. McMahon and Law were the first cardiology specialists in a 10-state region to use it. While similar devices have been available for pulmonary valve replacement, few children with Tetralogy of Fallot qualified because of their previous surgeries. Now, Dr. McMahon estimates that four out of five children with the condition will qualify.

The new procedure is a game-changer, he said. “We have many patients who live in fear of that surgery because they’ve been told they need another open-heart surgery since they were 8 or 10. We certainly have some patients who reasonably don’t want to do it and some who put it off. That becomes a problem because it means their heart is working harder.”

Dr. McMahon says the advantages to the Harmony device are obvious: “There’s a quicker recovery; lower risk of major complications and death; and they’re able to get on with their lives sooner.” The team has completed 10 procedures so far with no complications other than some arrhythmia that resolved with treatment.

Some patients returned to work or school three days after the procedure. And while the valve won’t last forever, Dr. McMahon expects a new valve could be inserted within the old one in the same manner. “That’s the overall goal of these valves,” he said. “To reduce the total number of heart surgeries that our patients need during their lifetime.”

William McMahon, M.D., is an interventional cardiologist at Children’s of Alabama and a professor in the Division of Pediatric Cardiology, University of Alabama at Birmingham Department of Pediatrics.

February 15, 2022 by childrensal

Cardiology, Inside Pediatrics

Improving Quality and Outcomes in Cardiology

Ashley Moellinger, RN, CRNP, Cardiovascular Services, Children’s of Alabama

Children’s of Alabama is deeply committed to continual improvement in every part of the care pathway. Two quality-improvement projects in cardiology are already showing the results.

Handoff of Care

Medical errors are the third-leading cause of death in the United States.[1] The Joint Commission reports that two-thirds of serious medical errors, or “sentinel events,” are tied to poor communication, and half involve communication during care handoff, such as when a patient is transferred from the intensive care unit (ICU) to surgery or back.[2]

The handoff is an important faultline for miscommunication that can lead to patient harm, said Children’s of Alabama cardiovascular intensivist Hayden Zaccagni, M.D. It’s not just communication between the intensivist and the surgeon; it involves the pediatric anesthesiologist, bedside and surgical nurses, advanced practice practitioners, and respiratory therapists.

“It’s a big team that cares for these patients,” Dr. Zaccagni said. Research shows that standardizing the handoff from the ICU to the operating room increases communication without delaying surgery and increased provider satisfaction and patient readiness for surgery while reducing errors.[3]^,[4]

The cardiology service didn’t have standardized protocol for handoffs, so Dr. Zaccagni, together with Ashley Moellinger, RN, CRNP, leda quality-improvement (QI) project to develop a process that prioritized clear, concise, and consistent communication from the cardiac ICU to the operating room or catheterization lab.

They started with a survey of 82 staff members, which found that 69 percent had experienced a safety event related to inadequate handoff. The survey also showed that communication was the primary barrier to transition followed by organizational barriers.

The team developed a tool and process for handoffs that involved all clinicians who interacted with the patient. “This multidisciplinary approach is so important,” said Moellinger.

Now, the night prior to surgery, the nurse practitioner, bedside nurse, and respiratory therapist complete a data form on the patient. The next day, the entire team meets at the bedside to review the form and bring up any concerns. “A big part of this is around situational awareness, or concerns we have about the patient that might not be obvious from reading through the chart or notes,” said Moellinger.When the patient is transferred, the team verbally goes through the tool again to ensure there are no outstanding questions or changes in condition.

The team is also tracking what it calls “moments of clarity”—when the process unveiled a potentially problematic issue such as a difficult airway, unavailability of vasoactive drip, patient cardiac arrest the prior night, or airway management for a patient with worsening oxygen levels.

The goal, or “smart aim,” was to demonstrate a standardized handoff in 80 percent of transition interactions, with 80 percent completion of patient data points by December 2021, and 95 percent compliance by July 2022.

Reintervention Reduction

This reintervention reduction QI project focuses on the most complex cardiothoracic surgery performed in newborns. Called the Norwood procedure, the surgery involves constructing a new, larger aorta for babies born with hypoplastic left heart syndrome. Nationally, patients who don’t require an intervention after their surgery have a mortality rate of about 6 percent compared to the 26 percent mortality rate in those who require another surgery or catheterization procedure.

The project, which is part of the National Pediatric Cardiac Quality Improvement Collaborative, was designed to understand why reinterventions occurred and identify opportunities to recognize the warning signs early in the post-operative period.

The Children’s team first performed a root-cause analysis of the 69 patients who required additional interventions between January 2015 and June 2020. That involved identifying what triggered the complication and how it could have been prevented. Of the 69 patients, 23 (34 percent) required an unplanned cardiac surgery or catheterization while hospitalized after the first-stage operation. Half of the surgical interventions were to explore unexplained bleeding, and half of the catheterization interventions were for conduit stenting to improve pulmonary blood flow. Fewer than five patients (12.5 percent) who required a reintervention died compared to none in the other group.

Reviewing the entire care pathway from the cardiovascular ICU to the operating room and back, including rates of post-operative bleeding and the timing for administering blood products, “we were essentially able to come up with a solution that we should communicate more effectively between team members in the operating room,” said Dr. Zaccagni. One way to improve communication is to wait at least 30 minutes in the operating room after closing the sternum to estimate chest tube output. Another is to standardize blood work when a patient is bleeding in case it’s due to a rebound effect of blood thinners given during the surgery. In addition, the team developed a standardized tool for the post-operative debriefing with the entire team.

The efforts are already paying off, said Moellinger, with fewer reinterventions since they began in 2020. “Standardization and, thus, reducing variation in everything we do is an important component for the best outcomes,” she said.

[1] Makary MA, Daniel M. Medical error—the third leading cause of death in the US. BMJ. 2016;353:i2139.

[2] The Joint Commission. Inadequate hand-off communication. Sentinel Event Alert. September 12, 2017. Issue 58.

[3] Caruso TJ, Marquez S, ,Luis J, et al. Standardized ICU to OR handoff increases communication without delaying surgery. Int J Health Care Qual. 2017;30(4):304-311.

[4] Joy BF, Elliott E, Hardy C, Sullivan C, Backer CL, Kane JM. Standardized multidisciplinary protocol improves handover of cardiac surgery patients to the intensive care unit. Pediatr Crit Care Med. 2011 May;12(3):304-8.

February 15, 2022 by childrensal

Cardiology, Inside Pediatrics, Pulmonology

Saving Children with Pulmonary Hypertension – One Patient at a Time

Children’s of Alabama cardiologist Frank Bennett Pearce, M.D.

When the cardiology team at Children’s of Alabama heard the family history of a 6-year-old boy who presented with an episode of syncope, they knew immediately what was wrong. His father had undergone a double lung transplant at the University of Alabama at Birmingham to cure his pulmonary hypertension (PH). Now his son had been diagnosed with the same thing.

But that wasn’t the only problem. The boy had also developed a supraventricular tachycardia requiring radiofrequency ablation, which was successful.

“So we cured that,” said Children’s cardiologist Frank Bennett Pearce, M.D., the boy’s cardiologist. But then the patient continued having episodes of syncope, particularly during exertion. “When that happens in patients with PH, it’s because the blood can’t get through the lungs to the left side of the heart, limiting cardiac output,” said Dr. Pearce. To address that problem, Dr. Pearce and his team performed an atrial septostomy, creating a tiny hole between the atria in the atrial septum. Second problem fixed.

Discharged on oral medications, the child did well with close follow up for several years, said Dr. Pearce, although he was vulnerable to pneumonia and other infections.

Then in 2020, at age 13, he took a turn for the worse. “There are three principal metabolic pathways involved in treatment of PH,” said Dr. Pearce. Two—endothelin and phosphodiesterase—have effective oral drugs for treatment. The third, the prostaglandin pathway, is more difficult to address, he said. In the past, it required a central line for IV infusions of treprostinil, a prostaglandin pathway medication. “Most families are very reluctant to go to the central line because it creates major problems in their lifestyle and is a quantum leap in terms of the negative effects on these children,” he said.

However, treprostinil can also be administered subcutaneously through a small catheter and external pump, much like an insulin pump. Unfortunately, the day the teen was scheduled for cardiac cath and initiation of subcutaneous treprostinil, he became very cyanotic. “We didn’t think it was safe,” Dr. Pearce said. Instead, the boy was admitted to the CVICU on inhaled and oral prostacyclin inhibitors. Despite increasing the dosage, his disease progressed. Finally, the team put him on the intravenous form of treprostinil, and he improved. Eventually, they were able to transition him to the subcutaneous form of the drug via the pump, and he became the first patient at Children’s to be initiated onto subcutaneous treprostinil.

He’s now home and undergoing evaluation for a lung transplant. “He’s a typical teenage kid but able to deal with all these challenges and keep a pretty good attitude, thanks to support from his family,” said Dr. Pearce. “He just hangs in there.”

August 27, 2021 by childrensal

Cardiology, Inside Pediatrics

T3: Clinical Decision Support Platform in the CVICU Improves Monitoring; Reduces Problems

Doctors-Cardiovascular-ICU-Monitoring-Etiometry-Resized

Right, Santiago Borasino, M.D., and left, Hayden J. Zaccagni, M.D.

An enduring issue in pediatrics is that so much of the technology used was developed for adults and must be retrofitted for children. That’s why the new software the cardiovascular ICU (CVICU) at Children’s of Alabama received for its monitoring devices is such a big deal. “It’s unique to the pediatric cardiovascular ICU population because it was developed initially for that population,” said cardiac intensivist Hayden J. Zaccagni, M.D.

The software, called T3 (trajectory, target and trigger), was developed by ICU software development company Etiometry with input from some of the top children’s hospitals in the country. Dr. Zaccagni calls it a “situational awareness tool,” one that pulls information from the telemetry unit, ventilator and other machines and displays all the data on one screen. It also provides past data and trends and uses algorithms to warn staff of the probability of low oxygen levels in the venous blood (a surrogate of a lower-functioning cardiac pump).

With 20 beds in the CVICU that are nearly always filled, anything that makes it easier for the team to track potential problems and potentially improve outcomes is a boon.

The software’s greatest value comes from the historical information it provides, said Dr. Zaccagni. Physicians and nurses can then use objective data to review events and improve their knowledge about what happened and why, he said. For instance, they use the data during extensive reviews of all cardiac arrest occurrences. “It shows the baseline, what happened before the arrest and what happened that led to the physiology failure,” he said. And that can identify opportunities for improvement.

“It provides two things we didn’t have before,” said cardiac intensivist Santiago Borasino, M.D. “The ability to see multiple vital signs trend at the same time on the same screen and the ability to see trends over time right at the bedside without running a report on a different computer.”

“Sometimes the vital signs might look normal, but that might be very abnormal compared to what the patient was experiencing six hours ago,” Dr. Borasino said.

It also improves rounding communication and efficiency, enabling the entire team, including the attending physician, fellow, bedside nurse, dietician, respiratory therapist and pharmacist, to view the patient’s history for the past 12-24 hours at the same time. “We want everyone on the same page,” Dr. Zaccagni said. “The goal is that everyone is aware of patients at risk for having an untoward event.”

The other advantage is the software’s ability to continually recalculate the algorithm based on the changes in vital signs. “As intensivists, we’ve been trained to put together information from different sources to create a picture of whether the patient is fine or not fine,” Dr. Borasino said. But those mental algorithms are fraught by memory and sometimes wrong. The software, however, provides robust data analyses and assigns a probability of a problem.

“The ability to view the history, see multiple vital signs at the same time and see data trends, I think, provides better monitoring and helps us find problems when they’re small rather than when they’re big,” said Dr. Borasino. “Everyone knows when the patient is crashing; the algorithm and the way the information is laid out in front of us might help us act before the patient is crashing.”

August 27, 2021 by childrensal

Cardiology, Inside Pediatrics

Children’s of Alabama Receives Prestigious Accreditation from Children’s Cardiomyopathy Foundation

Livie Wheeler of Pell City, Alabama was diagnosed with dilated cardiomyopathy and underwent a successful heart transplant at Children’s of Alabama. Livie was discharged home just in time for her second birthday.

Children’s of Alabama was recently named an accredited center of care by the Children’s Cardiomyopathy Foundation (CCF), a national nonprofit committed to improving the health outcomes and quality of life for children with cardiomyopathy.

“We’re glad to be able to participate,” said F. Bennett Pearce, M.D., outgoing medical director of the Pediatric Advanced Heart Failure and Transplant Program at Children’s of Alabama. “CCF promotes education and helps families connect and choose centers with experience in these kinds of patients.”

The Pediatric and Congenital Heart Center of Alabama at Children’s of Alabama is one of the largest pediatric cardiovascular programs in the Southeast. In 2018, its team of 250 dedicated professionals treated more than 230 patients with pediatric cardiomyopathy. The team includes surgeons, intensivists, cardiologists and many others, including nurses, social workers, child life specialists, genetic counselors, nutritionists, occupational and physical therapists, and chaplains.

“We have traditionally had very strong clinical abilities and success with treating a variety of these conditions,” Pearce said. “Over the 25 years that I’ve worked in the program, I feel we have been among the finest centers, but we have not been quite so active in getting the word out. That needs to change because we want to make families aware that there’s a good resource for them here.”

The CCF offers a plethora of educational and supportive programs for families, as well as a research grant program for basic, clinical, population/epidemiologic, or translational studies focused on primary pediatric cardiomyopathy.

Its accreditation program was established in 2017 to recognize excellence in diagnosing and treating pediatric cardiomyopathy and provide families with standardized center information to help them find an expert treatment center in their area. To date, 39 centers in the U.S. and Canada, including Children’s of Alabama, have been accredited.

The CCF has very strict criteria for accreditation. Centers must:

Manage 30 or more cardiomyopathy patients up to age 18 annually or 60 pediatric cardiomyopathy patient visits a year.
Have at least one pediatric cardiologist who treats patients with dilated, hypertrophic, restrictive arrhythmogenic and right ventricular or left ventricular non-compaction cardiomyopathy.
Be part of a teaching hospital affiliated with a medical school.
Offer the following:
- Prenatal or fetal echocardiography
- High quality imaging (echocardiogram, cardiac magnetic resonance imaging)
- Interventional cardiology (catheterization, endomyocardial biopsy)
- Pediatric cardiac electrophysiology
- Cardiac surgical services (septal myectomy, cardiac device implantation)
- Genetic testing and counseling
- Pediatric neurology
- Social work
- Child life services
Centers must also have at least one of the following (Children’s of Alabama meets all four):
- A specialized clinic or program focused on pediatric cardiomyopathy or familial hypertrophic cardiomyopathy with a dedicated team of professionals.
- Involvement with the North American Pediatric Cardiomyopathy Registry, Pediatric Cardiomyopathy Repository or Pediatric Heart Transplant Study Group.
- Engagement in pediatric cardiomyopathy research.
- Advanced heart failure management and transplantation.

“We have everything needed to offer to this group of patients,” Pearce said. “And we want to make sure that when a family confronts this difficult diagnosis, they can easily find our program and be assured that it is a good resource.”

January 16, 2020 by childrensal

Cardiology, Inside Pediatrics

Discharged with an iPad: Children’s of Alabama Uses Telehealth to Monitor Complex Heart Patients at Home

Children’s of Alabama has partnered with Locus Health to provide a special iPad app that connects parents with nurse practitioners who treat infants who have undergone complex surgery.

Babies born with a single ventricle must undergo three major open-heart surgeries by the time they are toddlers. The first and most complex surgery occurs at 1 to 2 weeks; the second between 4 and 12 months. The months spent at home between the two can be overwhelming for parents.

Now families served at Children’s of Alabama have a new tool to help them cope – an iPad containing a special app from Locus Health, a Charlottesville, Virginia-based company that develops software to ease the discharge process and transition from hospital to home. The app forms the core of a remote monitoring system that connects parents with the nurse practitioners at Children’s of Alabama who care for their infants.

“These parents have been through a tremendous amount of stress,” said Katelyn Staley, discharge coordinator for Cardiovascular Services at Children’s of Alabama. “Not only do they have a newborn, but the baby requires major open-heart surgery in that first week or two of life. Then they are discharged home; it’s an overwhelming process,” she said.

“The Locus platform was designed specifically for the pediatric patient population with congenital heart disease,” said Sarah Blair, RN, MSN, CRNP, of Children’s of Alabama’s Hearts at Home Program. More than a dozen of the country’s leading children’s hospitals now use the system, which studies find can reduce post-discharge emergency room visits as much as 40 percent and the total hospital days by up to two weeks.

Children’s of Alabama had been using another electronic program, but it was cumbersome, not user-friendly and difficult to extract data from. Before that, all data was collected the old-fashioned way – with paper and pencil.

With the Locus app, parents enter their child’s daily weight, oxygen saturation, heart rate, number of diapers, Synagis dosing and nutritional intake, noting if there is any vomiting or diarrhea. They can also upload photos and videos.

Timely information is critical. For instance, weight gain is vitally important because if the baby stops gaining or loses weight the team needs to intervene quickly before complications occur. In addition, values can be individualized for each infant depending on their medical status. “If a parent enters an out-of-range value it creates a red flag and prompts the caregiver to call the hospital immediately,” Staley said.

The data automatically populates the congenital heart clinical dashboard, which nurse practitioners and clinical nutritionists monitor. Parents can also see current and past data and even track trends across time, Blair said. Data can also be downloaded into a PDF and emailed to physicians.

The remote monitoring is also beneficial since many patients live hours from the hospital and may be followed by a local cardiologist. “Now we can share the information with the cardiologist where they live,” she said.

“It definitely keeps us in constant communication with the families,” Blair said. “We still call and talk to them, but it relieves some of that pressure.”

“Sending families home with the reassurance that nurse practitioners are logging into the system on a daily basis and that they have 24/7 access to a provider is very reassuring,” Staley said.

January 16, 2020 by childrensal

Cardiology, Uncategorized

Understanding Xenotransplantation’s Potential to Save Babies

The issue is simple: there are simply not enough hearts for all the children who need them. So 17% of all children who need a heart transplant die while waiting; this translates to 20% to 25% of infants.[1]

The University of Alabama at Birmingham (UAB) and Children’s of Alabama aim to change those dismal statistics with one of the most revolutionary approaches since the first heart was transplanted from one human to another in 1967 – xenotransplantation.

Thanks to a $19.5 million grant from biotechnology magnate United Therapeutics Corporation, UAB and Children’s have launched one of the top programs in the world dedicated to developing genetically modified solid organs from pig models for transplantation.

The idea isn’t new. Pig tissue has been used to replace heart valves for years, said cardiothoracic surgeon David Cleveland, M.D., MBA, who leads the program at Children’s. The greatest challenge with solid organs, he said, is overcoming immunological and physiological barriers.

If they can do that, “We believe that there’s huge potential to improve the lives of children,” he said.

Supporting Evidence

Earlier this year, 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.

“We found that very promising,” Cleveland said.

Another area of interest is producing immune tolerance by transplanting porcine thymus tissue to “re-educate” the immune system to accept the pig heart, said cardiac intensivist Leslie Rhodes, M.D. The idea comes from the fact that children can develop an immune system via a human thymus transplant. “We wonder if we could we train their immune system to be tolerant to the pig thymus transplant,” she said.

Infants are the ideal starting place, Cleveland said, not only because they have the highest wait list mortality of any other demographic waiting for a solid organ transplant, but because their immune systems are still naïve. Indeed, they do not develop antibodies to pig glycans during at least the first three months of life, Cleveland and his team wrote in a recent journal article, providing a “window of opportunity” for the transplant.[2]

The next step is a transplant in a non-human primate. “The FDA won’t even consider it until we can prove consistent survival in a non-human primate,” Rhodes said. They hope to perform their first transplant later this year.

Societal Concerns Addressed

The team is also aware of the societal issues around xenotransplantation. To address that, they surveyed the families of patients on the transplant list and the nurses and physicians who will care for these children.

”I was surprised by how positive they were,” Cleveland said. “I thought there would be more pushback than there was.” Still, he said, “I think there has to be major education,” once xenotransplantation becomes a reality. “The idea of replacing a heart with a pig heart will take some people a little time to get over.”

He’s confident it will happen, though. “UAB is going to be one of the centers in the world with the potential to make this happen,” he said. “We have children living in our ICU because there’s not enough cardiac function; they are having their birthdays here. It totally changes entire families to have a child in the hospital forever. There has to be another way.“

[1] Dipchand AI. Current state of pediatric cardiac transplantation. Ann Cardiothorac Surg. 2018;7(1):31–55. doi:10.21037/acs.2018.01.07

[2] Cleveland D, Adam Banks C, Hara H, Carlo WF, Mauchley DC, Cooper DKC. The Case for Cardiac Xenotransplantation in Neonates: Is Now the Time to Reconsider Xenotransplantation for Hypoplastic Left Heart Syndrome? Pediatr Cardiol. 2019;40(2):437-444.

Cutting-Edge Research

Learn more about various research areas at the University of Alabama at Birmingham.

August 20, 2019 by childrensal

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