To exclude certain patients, centers and professional societies have a general agreement on indications and contraindications, but in reality, any transplant program can and will transplant any patient it sees fit.
For example, patients with cancer diagnosed in the last five years, end stage liver disease, lung disease, or kidney disease are theoretically precluded from receiving a heart. So are active smokers and active users of illegal drugs. "But there are no hard and fast rules," Shah explained.
"The only caveat is that if your outcomes are lousy, you are held to a standard as far as the outcomes are concerned, based on a modest amount of expected survival for your program at one year, and other incremental time points at less than a year," he said. If a center's survival rates are more than 1.5 standard deviations lower than expected, "your program will be scrutinized" and possibly closed by federal payers.
Today, he said, heart transplant centers make these decisions on a case-by-case basis. "We have learned almost anecdotally what works and what doesn't, but the purpose of using a large database like this with rigorous follow up is that we can actually put some numbers to this risk."
Now, he says, transplant program leaders will have to ask themselves an important question: "If we knew this person would have a 50% chance of surviving one year, would we still have done it?"
There is, of course, a trade-off, Shah said. "The post-transplant outcomes would be better, but wait list mortality would be higher. The people you didn't give the heart to would likely be dead."
However, he added, "this is the first step to say the field needs to start measuring things, to look at outcomes critically and then decide what's acceptable."