Big Hearts and Little Devices Fuel Pediatric Cardiology

Brilliant engineering and endless compassion combine to improve and extend the lives of vulnerable children.

You may have never heard the product names that are at the literal heart of Abbott’s pediatric cardiology mission:

15mm Masters HP heart valve, Amplatzer Piccolo Occluder, HeartMate 3 left ventricular assist device (LVAD).

That’s not too surprising.

The names don’t dance across the tongue or page. They treat serious conditions that no one wants to think about — unless they have no other choice.

And the names of the people behind these technologies that protect and strengthen the littlest hearts are not ones we see often.

But maybe we should.

Because it’s the huge brains — and even bigger hearts — of the people behind these engineering marvels that make the difference.

“When you go into a hospital and see a baby who requires this technology, you forget about budgets you need to finish or the logistics of a test,” said Mike Meyer, director, research and development (R&D), Abbott’s Structural Heart business. “You can’t help but think that this child could be yours.”

The first thing one learns about these engineers/scientists is that those huge spirits prevent them from taking any kind of individual credit. They are all part of dedicated teams who work together to solve big problems for small patients and while they can speak on behalf of their development teams, they still prefer the teams’ work speaks for them all.

The Importance of Elegance

And one of the words that is spoken is “elegant.”

It’s how Chad Green, director, R&D, cardiac surgery for Abbott’s Structural Heart business describes the technology behind the small 15 mm Masters heart valve, a distant cry from the immense radar and communication systems for submarines and aircraft carriers he worked on previously.

“The heart valve has few parts and does the job it’s designed to do with no additional complexity, because the more elegant the design, the fewer things that can go wrong,” said Green.

“Everything we do is in the service of efficacy and safety. It needs to be durable and interact with blood in a gentle way that adapts to each individual patient who receives it and each individual physician who places it.”

The individuals that inspire and inform that work include Green’s own daughters, born 26 and 19 years ago. In parenting terms: yesterday.

“I remember those births and thinking how vulnerable they were. Working on a device specifically designed for children takes the work to another level,” said Green.

“Going to work every day thinking my work will help people is great. Knowing it will help children makes it that much better.”

Where Medicine and Engineering Meet

While many of his current peers came straight out of school wanting to build bridges and sophisticated mechanical systems, Mike Meyer took a slightly different path. He decided to double up on his biology degree by returning for one in mechanical engineering with an emphasis on biomedicine.

Like other engineers, Meyer wanted to solve problems and design solutions, finding his passion in cardiac medicine, working on a series of heart valves used to treat many different conditions and patients.

About 10 years ago, he went to Germany and spent some fateful time with a group of pediatric cardiologists. “I realized they were a very different group. We’d go into children’s hospitals, and you could tell, these doctors were something special,” he said.

“They had extraordinary knowledge and skills and were the best bets for these children to survive and thrive.”

Those same physicians, however, would quickly concede that their skills have limited impact without pediatric cardiology technology like the Amplatzer Piccolo Occluder, a smaller-than-a-pea device that Meyer and team helped develop.

The device closes the connection between two blood vessels leading from the hearts of premature infants, blocking harmful backflow of blood, allowing babies to breathe easier and get them off a ventilator faster. A catheter delivers the device, which eliminates the risks of open-chest surgery.

‘That’s When It Really Hits Home’

Even after working on this and similar cardiac technology for years, Meyer continues to be amazed at what this combination of medicine and engineering can accomplish.

“Working on cardiovascular products is always cool because you can tell that your work is making a difference. Knowing someone will have 5, 10 or 15 extra years of quality life because of your work is amazing,” Meyer said.

“But seeing a Piccolo occluder being used on a pre-term infant and realizing that we are part of a team that may be the reason this baby has a long and full life? That’s been incredibly meaningful to me.

“You see pictures of little babies on the table and realize you aren’t engineering a car part or a new set of headphones, but actually giving a chance at life — and a quality of life — to these young kids. That’s when it really hits home.”

Combining Life and Work

This pervasive need to meld engineering and medicine, brain and heart, work and home, is inherently understood by the people who work on pediatric cardiovascular devices. Kevin Bourque, vice president, R&D for the heart failure business at Abbott is certainly no exception.

Much of his work has been focused on the evolution of the HeartMate line of left ventricular assist devices (LVAD), including making the smaller third- generation device, the HeartMate 3 LVAD, which earned FDA approval for pediatric use. Designing technologies used to treat children with heart issues fuels Bourque's mission to, “always find the safest way to get the best result.”

He sees the natural connections between design and medicine, noting that the best part of his job is collaborating with doctors, especially those whose interests go beyond medicine. “We need pure doctors and engineers, but medical device work benefits from those people with multiple passions,” said Bourque.

Devices like Heart Mate 3 hold a special place in his heart and mind because, in the best cases, it can be hard to tell where one starts and the other finishes. “When it comes together and the device and body meld, it’s an intrinsically connected thing.”

Just like his professional and personal life. “I’m no good at separating my work and home lives, so being a parent definitely impacts everything I do. There is something different about working on a device that can be used on kids.”

This connection has continued through the evolution of the HeartMate line, in which each iteration is smaller. Since the device is placed in the chest cavity, the more compact the device, the smaller the potential patient can be.

Every Picture Tells a Story

The use of the HeartMate 3 has not only increased treatment options for younger heart patients but helps drive the commitment of the development teams.

“Even though it’s used in less than a hundred pediatric patients per year, as parents we don’t think of large numbers but, rather, what if that one child is yours,” said Bourque.

Like many parents, Bourque has pictures of children in his office. Unlike many parents, most of his photos feature young people who have received implanted Abbott devices, rather than his genetic code.

“Those pictures of young patients are our real motivation, the lives we’ve been able to impact,” said Bourque. “It’s super important to honor them.”

Elegant solutions. Inspired engineering. Connecting worlds.

Every picture tells a singular story. Every story celebrates countless hearts.

15mm Masters HP Mechanical Heart Valve

Rx Only

Important Safety Information

Masters Series Mechanical Heart Valve

Indications for Use

The SJM™ Masters Series Mechanical Heart Valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic or mitral heart valve. This device may also be used to replace a previously implanted mitral or aortic prosthetic valve.

Contraindications

The SJM™ Masters Series Mechanical Heart Valve is contraindicated for individuals unable to tolerate anticoagulation therapy.

Potential Adverse Events

Complications associated with replacement mechanical heart valves include, but are not limited to, hemolysis, infections, thrombus, or thromboembolism, valve dehiscence, unacceptable hemodynamic performance, hemorrhagic complications secondary to anticoagulation therapy, prosthetic failure, failure or death. Any of these complications may require reoperation or explantation of the device.

AMPLATZER PICCOLO OCCLUDER

Rx Only

AMPLATZER PICCOLO™ OCCLUDER

INDICATIONS AND USAGE

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

CONTRAINDICATIONS

Weight < 700 grams at time of the procedure; Age < 3 days at time of procedure; Coarctation of the aorta; Left pulmonary artery stenosis; Cardiac output that is dependent on right to left shunt through the PDA due to pulmonary hypertension; Intracardiac thrombus that may interfere with the implant procedure; Active infection requiring treatment at the time of implant; Patients with a PDA length smaller than 3 mm; Patients with a PDA diameter that is greater than 4 mm at the narrowest portion.

POTENTIAL ADVERSE EVENTS

Potential adverse events that may occur during or after a procedure using this device may include, but are not limited to: Air embolus, Allergic reaction, Anemia, Anesthesia reactions, Apnea, Arrhythmia, Bleeding, Cardiac perforation, Cardiac tamponade, Chest pain, Device embolization, Device erosion, Death, Endocarditis, Fever, Headache/migraine, Hemolysis, Hematoma, Hypertension, Hypotension, Infection, Myocardial infarction, Palpitations, Partial obstruction of aorta, Partial obstruction of pulmonary artery, Pericardial effusion, Pericarditis, Peripheral embolism, Pleural effusion, Pulmonary embolism, Re-intervention for device removal, Respiratory distress, Stroke, Thrombus, Transient ischemic attack, Valvular regurgitation, Vascular access site injury, Vascular occlusion, Vessel perforation.

HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAD)

Indications, Safety & Warnings

Rx Only

Brief Summary: Prior to using these devices, please review the Instructions For Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

HeartMate 3™ Left Ventricular Assist System

Indications: The HeartMate 3 Left Ventricular Assist System is indicated for providing short- and long-term mechanical circulatory support (e.g., as bridge to transplant or myocardial recovery, or destination therapy) in adult and pediatric patients with advanced refractory left ventricular heart failure and with an appropriate body surface area.

Contraindications: The HeartMate 3 Left Ventricular Assist System is contraindicated for patients who cannot tolerate, or who are allergic to, anticoagulation therapy.

Adverse Events: Adverse events that may be associated with the use of the HeartMate 3™ Left Ventricular Assist System are: death, bleeding, cardiac arrhythmia, localized infection, right heart failure, respiratory failure, device malfunctions, driveline infection, renal dysfunction, sepsis, stroke, other neurological event (not stroke-related), hepatic dysfunction, psychiatric episode, venous thromboembolism, hypertension, arterial non-central nervous system (CNS) thromboembolism, pericardial fluid collection, pump pocket or pseudo pocket infection, myocardial infarction, wound dehiscence, hemolysis (not associated with suspected device thrombosis) or pump thrombosis.

HeartMate 3 Coring Tool

Indications: For the HeartMate 3 Left Ventricular Assist System (LVAS) Indications for Use, please refer to the HeartMate 3 LVAS Instructions for Use. The HeartMate 3™ Coring Tool is intended for use with the HeartMate 3 LVAS. The HeartMate 3 Coring Tool provides a means to resect a plug of myocardium from the left ventricle, which allows for HeartMate 3 inflow cannula insertion.

Contraindications: The use of the HeartMate 3 Coring Tool is contraindicated in patients who are contraindicated for HeartMate 3 Left Ventricular Assist System (LVAS) therapy.

Adverse Events: The following adverse events may be associated with the use of the HeartMate 3 Coring Tool. Adverse events are listed in anticipated decreasing order of frequency, except for death, which appears first as it is a non-reversible complication: death, bleeding (perioperative or late), local infection, local ischemia, cardiac arrhythmia, stroke, peripheral thromboembolic event, neurologic dysfunction, hemolysis, sepsis.

Connected tech, linked by innovation
Smallest Mechanical Heart Valve Saved her Life

Baby Sadie received the world's smallest mechanical heart valve, and her life instantly changed. Today, she's a spunky 10-year-old.

Hello, welcome to Abbott.