One option they presented was a medication called dobutamine, which strengthens the heart muscle and improves blood flow. It’s generally a last resort for patients when other heart medications don’t work, and not something patients take for the long term. Judy thought it might give her enough time to take a final vacation to Sedona, Arizona, and get her affairs in order.
“We called the medication ‘jet fuel’ because it immediately made me feel better,” Judy said. “I finally had my appetite back, and pretty soon I was doing laps around the hospital corridors.” Despite her improvement, Judy learned she wouldn’t be able to travel while taking dobutamine and was resigned to continue with the palliative care.
But doctors noticed her improvement and energy and thought she might be a candidate for a left ventricular assist device (LVAD). There was a trial underway at U of U Health for a new mechanical circulatory support device called BrioVAD. The multidisciplinary advanced heart failure team agreed she should consider the trial, as did Craig Selzman, MD, Surgical Director of the Cardiac Mechanical Support and Heart Transplant program and Chief of the Division of Cardiothoracic Surgery at the University of Utah. Dr. Selzman would eventually be the surgeon to perform Judy’s BrioVAD procedure.
“BrioVAD is a new type of left ventricular assist device, or LVAD,” Dr. Selzman said. There were a lot of advances in mechanical circulatory support devices in the late 1990s and early 2000s, but in the last decade, there has only been one main device for patients and providers to utilize. That current device works well, but with no competition there is little incentive for major innovation.
LVADs are surgically implanted metal devices that help pump blood through the heart when the left ventricle can’t do that well on its own. They also have a controller—a small computer that operates the device—and a battery supply to keep the device pumping. The latter two components are outside of the person’s body, connected to the metal tube with a driveline that goes through a small opening in the patient’s upper abdomen.
As a new device, the BrioVAD must undergo rigorous testing through the U.S. Food and Drug Administration (FDA) to demonstrate efficacy and safety. Currently, it’s in the early stages of those trials, with a small number of hospitals selected to participate. Once complete, the FDA will evaluate the results of the initial trial to determine if it is safe enough to conduct a larger trial at more surgical facilities nationwide.
LVADs are generally for patients in a late stage of heart failure, Dr. Selzman says. For some patients, it is a “bridge” treatment to keep their heart working while awaiting a heart transplant. For others, it can deliver better quality of life for several months or years after heart function declines. In either case, the devices are not something that most patients want, and they can be challenging to manage with all the components and care required.
The potential downsides of the implanted device—namely, having two external components she would have to tote around all the time and an open wound where the driveline went into her body—were enough to make Judy unsure about whether to move ahead.
“It looked pretty uncomfortable and unwieldy to carry the stuff around,” Judy said. She was leaning away from participation in the trial, but then met Steve, another patient who had recently undergone surgery for an LVAD. “He was the same age as me and was really enthusiastic about how much the device had improved his life,” she said.
As Judy considered her options, she recalled a conversation with the teenage son of some friends. He asked what she had to lose by just taking the tests to see if she was eligible. “Between that conversation and Steve’s endorsement, I figured it was worth the effort to at least get the testing done,” she said. “I also thought that if I didn’t make it much longer, at least doing this experiment might help someone else.”
“Every clinical trial has a very prescriptive set of inclusion and exclusion criteria,” Dr. Selzman said. “We screen patients who might be eligible, but only about one in five make it through to actually participate.” In addition to the clinical trial screening, the team at U of U Health also examines factors like whether a patient is likely to be compliant with their medications after surgery, and whether they have the right level of support to care for them following these intensive procedures. This ensures that every patient will have the best chance at a good long-term outcome.
The tests revealed she was eligible, but Judy still had not decided whether to move ahead with the trial, and her condition was worsening. Doctors originally thought she might be able to take dobutamine for anywhere from two months to a year or more, but it stopped working within a week. Judy was rushed into surgery to get a balloon that would keep her heart pumping, and she and her husband had to decide that afternoon whether to move forward with the LVAD trial.
She decided to do it and was selected as the third patient in the U.S. to get the new device implanted (the trial also includes a control group of patients who get a conventional LVAD device). On January 20, less than two weeks after being admitted to the hospital for heart failure, she went in for surgery to get a BrioVAD.
“The approach we take with each [LVAD surgery] patient will be specific to their situation,” Dr. Selzman said. “For Judy, that was an open-heart procedure to place a metal tube in her heart, which is pretty straightforward, but there are still a lot of unknowns.”
For example, a surgeon doesn’t know how well the patient’s right ventricle is working, how other organs in the patient’s body will react, or whether the patient will be at higher risk for stroke or bleeding that can occur in open heart surgeries. All of these can complicate the surgery and recovery. Judy’s procedure went well, although she did have some bleeding and had to have that repaired with a second surgery a day later.
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