As someone with a faulty valve and other sundry heart defects, I don't see how you can read this article and not fault the FDA.
I've gone through two periods of extreme shortness of breath, it's not a good way to live, it's not a good way to die.
Especially if you can't even volunteer to move research forward.
I'm a big fan of countries who have made organ donation opt-in as the default.
Is 660k deaths per year due to heart failure insufficient to let people volunteer? Am I missing something here?