If he manages to survive 60 days or even longer, this first test of the implant heart will be considered a success, opening the door for even more patients to try it. In time, the people at Abiomed hope the heart will be widely used to save lives. The heart and its battery-pack power system are designed for use at home, so it can readily be plugged into an electric outlet to recharge when the batteries run down. Patients would carry spare charged batteries when away from home.
This pioneering test of the device is also the first test of the Independent Patient Advocacy Council. "It has gone wonderfully in terms of receptiveness, not only of the institution [Jewish Hospital], but also the patient and his family," said Dr. Douglas McNair, who came up with the idea for the patients' advocates, arranged the trust and keeps track of the program. "What I've been told by the advocate is that he felt very good" with how the interaction progressed.
It was McNair, vice president for clinical research at Abiomed, who insisted three years ago that truly independent advocates be recruited to help patients who were in line to get artificial hearts.
McNair said that when the first patient and his family were offered the advocate's help, "they gladly asked for a discussion with the advocate. They had a series of discussions throughout several days that were detailed and extensive. It seems to be a useful addition to the normal informed-consent process." In fact, Morreim said, this first human test of the mechanical heart "sets an excellent precedent" for the advocacy system.
Morreim and McNair would not identify the advocate in Louisville or the advocates they've recruited at other medical centers, because of the need to ensure patient privacy. They worry that if hospital staff members learn who the advocates are, their visits to hospitals would perhaps reveal some patients' identities against the families' wishes. Morreim and McNair said it has taken time to find and recruit the advocates, because these people need a combination of talents, must have enough time for the tasks at hand, and have to be extraordinarily compassionate and understanding. They must also have deep experience within the medical system, either as doctors, nurses or in allied occupations.
"It depends on our people having a deep personal devotion to how people in these life-threatening situations are cared for," McNair said. "And each advocate has a history of commitment to care decision-making. Some of them are retired and are volunteering, but others are 30 or 40 years old, individuals whose professional interests have straddled the boundary between curative and palliative care." Morreim said most of those recruited "jumped at the chance to participate, because advocacy could be such an important thing to introduce to research." But the advocate's job is not clear-cut. An independent approach funded by private money hasn't been tried before. So, Morreim said, "we're kind of making it up as we go along." Federal rules already require research institutions using government money to set up "institutional review boards" to oversee human experimentation, but the members typically include hospital staff and a few outside "public" representatives.
In contrast, Abiomed's patient advocates are intended to be completely unfettered by the company or the institutions involved in the experiments.