Beat goes on for UCH patient, thanks to cardiac assist device trial

'It was night and day ... how much better I felt'
November 2nd, 2015

 

Ed Jungbluth, 81, is the first patient at UCHealth University of Colorado Hospital to receive the HeartMate 3 left ventricular assist device, now in clinical trial.

Ed Jungbluth spent eight years in the Marine Corps, a portion of it as a line sergeant in charge of supplying food, radios and equipment for soldiers stationed in Japan during the Korean War. After his honorable discharge, he completed stints in leadership positions promoting tourism in Colorado and New Mexico.

Jungbluth looks forward to more time with Mimi, his wife of 48 years.

At 81, Jungbluth is a plainspoken, articulate man with a strong personality and a wife and marriage to match. He’s been married to Mimi for 48 years. Physically, however, Jungbluth’s congestive heart disease, which led to a heart attack in 1988, has made raking leaves or painting the trim on his home monumental tasks. Until recently, there was little hope of improvement.

“I had mushrooming problems,” he said. “I was tired, weak and lethargic. I couldn’t do much. I couldn’t breathe.”

Cardiac surgeon Joseph Cleveland, MD, is one of four principal investigators for the trial of the HeartMate 3.

His cardiologist in Albuquerque, N.M., referred Jungbluth to UCHealth University of Colorado Hospital, and on Sept. 14, he underwent a procedure to give his ailing heart a boost. Surgeons Ashok Babu, MD, and Joseph Cleveland, MD, implanted in Jungbluth a left ventricular assist device (LVAD) capable of pumping up to 10 liters (2.6 gallons) of oxygen-rich blood per minute to his body.

First look at a new LVAD

Andreas Brieke, MD, medical director of the Mechanical Circulatory Support Program at UCH.

Jungbluth is the first UCH patient enrolled in the MOMENTUM 3 clinical trial of Thoratec Corporation’s HeartMate 3 LVAD. The trial ultimately aims to sign up slightly more than 1,000 patients at 60 sites nationwide; UCH is the only participating hospital in the Rocky Mountain region. The device is being trialed both for patients who need circulatory support as a bridge to heart transplant and for “destination therapy” patients, like Jungbluth, who are not transplant candidates.

Cleveland is one of four national principal investigators for the trial, which compares the safety and efficacy of HeartMate 3 to its predecessor, the HeartMate II.

The HeartMate 3 has the same pumping power as the HeartMate II, said Andreas Brieke, MD, medical director of the Mechanical Circulatory Support Program at UCH. One important change in the new device, Brieke said, is the elimination of friction-causing bearings to suspend the rotor, which provides the device’s pumping power. Instead of bearings, the rotor of the HeartMate 3 is supported in the bloodstream by magnets, Brieke said. Without friction, there is less wear and tear on the device.

This design also creates larger gaps between the rotor and the housing of the device, Brieke said. The aim is to reduce destructive shearing of red blood cells as they flow through. This shearing can lead to chronic anemia and blood clotting, which is a problem that increases the risk of stroke in LVAD patients.

The wider space between rotor and housing means the device will be less likely to “beat up the blood,” as Cleveland put it. “It’s like the difference between driving your car down I-25 instead of a narrow alleyway.”

The HeartMate 3 includes “artificial pulse” technology, which is designed to imitate the normal flow of blood in the body as it is pumped from the heart. Every two seconds the pump “revs down” and then quickly increases the number of revolutions, Brieke said. This fills the pump with blood, making it work harder, thereby washing out the internal mechanism and reducing the chance of blood becoming stagnant and clotting, he explained.

“Blood is not like oil,” Brieke said. “It is a living substance, and blood will clot with less-than-normal flow.” In addition, a more regular pulse of blood to the organs of the body could help to reduce bleeding in areas like the GI tract, a problem frequently associated with LVADs in the past, Brieke said. Whether or not the HeartMate 3 helps with that problem remains to be seen, he emphasized.

From the surgical perspective, Cleveland said the HeartMate 3 is smaller and therefore no longer requires surgeons to create a pocket for the device outside the pericardium – the membrane surrounding the heart – by cutting the patient’s diaphragm. Instead, surgeons cut a smaller ‘V’ shape to reach the bottom of the pericardium, where they implant the device.

“There is less trauma and risk of infection for the patient,” Cleveland said.

Faster enrollment?

Brieke said the hospital can enroll a maximum of 50 patients in MOMENTUM 3, but would be pleased to reach 20 to 40 who qualify. For now, the device is approved for Medicare patients, but Cleveland said some private insurers will not pay for investigational devices. Nevertheless, he said he anticipates that enrollment in the trial will be “incredibly rapid,” in part because of a change in study design.

Unlike traditional clinical trials, which require enrollment to stop for 12 to 18 months for data analysis before they can resume, the MOMENTUM 3 trial will enroll the first third of the total, seal and lock the data, and allow the next third to enroll, Cleveland said. The same process will apply to the final patient group. In the traditional approach, only a relative handful of patients could receive a trial device under a process called continued access protocol while the FDA was analyzing data.

“We will now continuously roll to the enrollment target,” Cleveland said.

Life with the pump

Jungbluth will help Cleveland and colleagues learn about the new device. Not quite three weeks after the surgery, he sat in a chair next to Mimi in his room on the 8 East Rehabilitation Medicine Unit at UCH. He was dealing with inflammation and pain in his left knee – not related to the surgery – and still had a regimen of physical, occupational, and speech therapy in front of him. He and Mimi also were learning what Jungbluth called “the care and feeding of the LVAD,” including its batteries, the controller for the pump, and the sterile dressing to secure them.

None of it discouraged Jungbluth. “It was night and day when I woke up in recovery how much better I felt,” he said. “I look forward to the therapy even if it is uncomfortable. I want to get through it as an ‘A’ student, because that will have an effect on my tentative departure date from the hospital.”

He and Mimi will need to stay in the Denver area for weekly clinic visits until Brieke determines that all medical issues have been resolved and has fine-tuned the pump settings – at least a couple of months. Once Jungbluth is stable, he can go home to Albuquerque, with a required study visit 30 days later, then follow-ups every three months. He has phone numbers for his nurses that he can use around the clock to head off potential problems.

Mimi, herself a 21-year breast cancer survivor, said she and Ed have simple goals: walking their small dog Punkin, a picture of whom they taped to the wall of the room on the Rehabilitation Unit, and celebrating their 50th wedding anniversary together at the Ranchers Club steakhouse in Albuquerque.

“We’re not afraid to die,” Mimi said. “We want to live.”

She had grateful words for the providers at UCH who have cared for Ed and supported her. “Their care is off the charts,” she said. “This is a loving place.”

Ed echoed her words. “I couldn’t ask for anything more,” he said. “I’ve been blown away by the nurses, physicians, and physical therapists and their attentiveness.”

He then issued himself a challenge. “I just wanted to get better, and I will tackle this head on. I want to live my remaining life as a happy camper.”

About the author

Tyler Smith is a freelance writer based in metro Denver.