The device, also known as the HeartWare HVAD, is a mechanical pump that assists the heart in pumping blood. Surgeons attach the device to the patient's heart to advance blood flow and heart function. The device is powered externally, typically through battery and electrical power.
The first patient, who Froedtert had been in the process of caring for, had been living on medications until his heart disease became too disabling. He developed medical therapy refractory in which he remained symptomatic to the point that he couldn't do anything without feeling tired and short of breath.
His heart weakened to the point that Froedtert's medical team had no other options, said Dr. Claudius Mahr, cardiologist at Froedtert & MCW, who manages heart failure patients across a continuum of care through medications, devices and transplants.
"Once it got to the point that his heart got so weak that it couldn't supply his kidneys any more, we knew we had to do something sooner rather than later," Mahr said.
Physicians operated in early December after the device received FDA approval in November. The patient had a left ventricular assist device (LVAD) implanted to pump blood to the aorta from the left ventricle. A right ventricular assist device (RVAD) sends blood to the pulmonary artery from the right ventricle, and a BiVAD pumps blood to both ventricles.
In its third generation, the device is much smaller than previous versions – about the size of a golf ball – with fewer moving parts less prone to wear. It fits in the same cavity the heart is positioned in and is magnetically levitated. It's also gentle on red blood cells and is lubricated by the patient's own blood. The HeartWare HVAD can be used as a bridge to transplant to sustain a patient for potentially years until a donor heart becomes available. The device can also function as permanent therapy, or "destination" therapy, for patients who do not medically qualify as transplant candidates.
"It's much easier to implant, and I think that the patient's discomfort and ability to get up and around sooner is much improved, and it will be able to be used in a much wider range of patients," said Dr. Robert Love, cardiothoracic surgeon at Froedtert & MCW, who performed the open heart surgery to secure the device.
In this first operation, the device is serving as a bridge to transplant. Physicians hope to be able to bridge the patient to transplantation successfully, at which point the HeartWare HVAD will be removed.
Immediately following the operation, patients rest in the intensive care unit for a few days until they're stable enough to come off their intravenous medications and can be managed with heart failure medications. On average, patients remain in the hospital for two weeks to be closely monitored after these kinds of devices are implanted. They can usually resume much of their daily routine once released from the oversight of doctors.
While the device has been studied extensively in clinical trials as a bridge to transplant, it is in the process of being evaluated as a solution for destination therapy. Although every patient responds a little differently, physicians do know that people can survive for several years with the device alone even if they never get a transplant, Mahr said.
Froedtert has had a considerably higher success rate implementing a VAD as a bridge to transplant than the national average rate. In terms of using the device as destination therapy, Froedtert is certified by the Joint Commission, a national health care certification organization.
"I think we have a great team of dedicated experts working together collaboratively for the interest of our patients," Mahr said. "It's a remarkable group of individuals of various disciplines who work together to provide the best care for our patients."
The health care provider's success can also be attributed to its careful selection of patients who will benefit most from a VAD.
"We make sure that they're optimally managed on medicines and that they truly can't improve on medicines," Love said.
According to Mahr, 100,000 patients living with end-stage heart failure would potentially benefit from a heart transplant, but only 2,200 heart transplants are performed in the United States each year due to a shortage of donor availability.
"The math is it's just not available for as many people who would need it," Mahr said.
So the VAD offers a viable alternative for heart failure patients who aren't making strides with medication.
While Mahr acknowledges that this latest version of the VAD has revolutionized the medical field, he also recognizes the lack of resources and capable physicians to address the medical needs of every individual battling heart failure, which remains a significant public health problem.
"There's a lot of demand on the part of our patients and unfortunately not enough to meet that demand, so we just provide the best care we are able," he said.