The Five Man Electrical Band Was Right

"Signs, signs, everywhere a sign, blocking up the scenery, breaking my mind, do this/don't do that, can't you read the signs?" (Five Man Electrical Band)

If you've had any interaction whatsoever with the medical, pharmaceutical, or insurance industry, you've no doubt encountered rules. They have rules for everything: how long you can stay in the hospital, what constitutes an "emergency," orders for filing claims, time windows for prescription refills, who can prescribe what, referrals, percentage caps on co-pays and coverage, on and on and on.

While I still have to deal with most of that stuff, it's been a little unnerving how mushy some of the rules are for the TAH itself, not to mention some of the gaps in my practical care. The problem is that this whole notion of sending a patient home to live with an artificial heart is so new, there aren't a lot of protocols in place. There are some hard fast rules about how often to change out the machine (120 days), when to change the filter (once a week), the range of your PT/INR (blood coagulation - and this is a biggie), blood sugar levels, etc. But in terms of day to day issues, there's a lot of uncharted territory. And we've encountered a lot of unexplained things.

We underwent a 30-something odd hour training class in which we handled the equipment, tested rigorously, demonstrated proficiency, participated in trial runs away from the comfort of the HVIC unit, and signed agreements that we would care for the equipment and such. We learned what each beep and boop meant, what the alarm button colors meant, and how to methodically assess the problem when alarms sounded.

When we got home, the machine started doing weird things. Things no one had told us about. For instance, when unplugged, the machine emits a series of beeps at about 20 minute intervals. We finally realized that the beeps corresponded to each 20% mark on the battery life indicators. It's great because it helps me keep track of how much battery life I have left without having to look at the machine itself. Problem is, this is mentioned not a single time in the literature, nor was it mentioned in the class, nor has our device coordinator ever heard of this before. I got a new machine last week and it does the same thing, only with both drivers, they didn't do it all the time. Sometimes I would hear nothing for 3 hours, then a low battery low alarm sounds off. No warning. The new driver emits the same beeping sound intermittently even when I'm plugged in. No one knows why. We think it's probably beeping to let us know when each battery is fully charged after plugging in, but that doesn't seem consistent either. The machine functions properly, and has been rigorously tested by the Syncardia company, and two separate bio-engineering teams at Penn State.  But there's no explanation for these inconsistent alarms. I try not to let it unnerve me but it's a little more than a distraction or curiosity when the thing is controlling your heartbeat.

I also detailed in the last post that I essentially have two wound sites - the canula site where the driver tubes enter the body, and the Picc line. I guess "wound" isn't the right word but they have to be treated with extreme care to prevent infection - it's not like they can just remove the canulas because the site got infected. There's no backup for that. The Picc line is important because of weekly blood draws, and the immediate access it gives nurses if I need emergency meds. After having blood drawn conventionally for labs about 6-8 times a month starting back in 2013 (and 3-4 times a week in 2015), my veins are trashed. Even the instructor in the Penn State lab confided that they would soon have to start using veins in my feet and legs if my arms didn't get a rest. So the Picc line is my friend.

Upon leaving the hospital, Christie was "trained" to clean the canula site and change the dressing. She's been doing this for patients for years, not to mention much more complicated wound care, so that was no problem. Then came time for the Picc line dressing to be changed, and blood to be drawn for labs. She wasn't allowed to do it - we were given a dozen reasons why (all asinine) - if it gets infected, insurance won't know who to blame and whether to cover the following treatment - only RN's employed on the HVIC are "covered" to draw blood through a Picc line. This couldn't be done in the general lab since lab draws MUST be done by RN's and the lab does not employ one. The cancer infusion center draws blood from Picc lines, but I'm not a cancer patient. Though Christie does blood draws for labs dozens of times per week, and a home health RN is allowed to do it, AND she's changing the dressing on a much more dangerous open wound (the canula site), she was instructed unequivocally not to do anything with the Picc site.

So where was I supposed to get labs drawn? Home health costs $27 a pop, $54 a week. That adds up fast when you're already going broke paying medication co-pays and the primary breadwinner is missing work because of all the doctor appointments. The spouse (in my case the RN) changing the canula dressing can't do it. The lab can't do it. So what do I do? We posed this question to three different device coordinators, three intensivists,  a cardiologist, two nurse practitioners, and every HVIC nurse we could talk to. No one had a definitive answer. There was no protocol for this because I was the very first patient sent home on a TAH, needing bi-weekly blood draws, and needing them done via a Picc line. It started to seem like all involved wanted Christie to do the blood draws - despite their official instructions not to, wink wink. If an infection actually did occur, she'd be left holding the bag, whether it was her fault or not.

Because she works at Penn State, she was able to circumvent the insanity and get an order for me to have labs drawn in the cancer infusion center. What about patients whose spouse doesn't work for Penn State? What do they do? There is no answer.

PT/INR checks are part of this mess as well. I need them three times a week to ensure my blood isn't thickening, putting me at risk for stroke. They cannot be skipped. Again, a home health nurse can do it for $27 a pop. Or we travel the hour round-trip to the INR clinic so they can prick my finger, put a drop of blood on a slide, and feed it to a handheld machine. Don't they have these for home use? Why yes, they do. But insurance will only pay for it to be used once per week. That helps, but what about the other two times? Why won't they cover three times per week since I'm at a higher risk than most, due to the TAH? What's a TAH? You've never heard of a TAH? Oh, you don't have a box to check for "TAH" on your claim paperwork? You have to file it under LVAD? Then what happens? Insurance will cover one stick per week, like they do for LVAD patients? But I don't have an LVAD, I have a TAH. Remember? I was just telling you about the TAH? You don't have a box for that?

You get the idea.

Speaking of no box to check, this is especially interesting when it comes to OPTN and UNOS, the organizations that essentially oversee the waiting list for transplants. They also have no box to check. I'm sure I've posted info on how this works before, but as a quick refresher, the list works like this:

Status 1A: the most urgent, will-die-very-soon-without-organ patients, who are likely living in the hospital hooked up to life-sustaining devices.
Status 1B: patient needs a transplant asap, but isn't at death's door - possibly spends time in the hospital as a 1A patient, but mostly lives at home with some type of device or intravenous drug dependency.
Status 2: patient who eventually needs a transplant, but doesn't need any type of life-sustaining devices and is being managed with oral drugs.
Status 7: patient who could have been any of the above but is currently sick, away from the transplant facility, or for some temporary reason unable to undergo surgery at the present time (usually sick with flu, cold, etc.)

I was Status 2 before the TAH when I was at home. When I would spend a couple of weeks in the hospital, with a Swans cath and intravenous drugs, my status was elevated to 1A. When I went home, back to Status 2.

Most people on LVADs are considered 1B's because they don't have to live in the hospital, and the device is sustaining them at home. In most cases, should the LVAD stop doing the trick, they would be hospitalized and become 1A, probably dependent on bypass machines, intravenous drugs, etc. until they can get a heart.

TAH's are classified as LVADs because UNOS and OPTN have yet to seriously evaluate exactly how TAH patients should be treated in relation to the waiting list. The problem is, a TAH is NOT the same thing as an LVAD. An LVAD patient has several options left if their device starts to fail, or their condition worsens while on the device. TAH patients have already exhausted every other option. There is no further treatment if the TAH fails. At that point, they are in as much if not more trouble then a 1A patient because there's no way to "treat" an artificial heart. You can't coax a few more days or weeks from it. It's a machine. For now, TAH patients are 2's unless admitted to the hospital, or they can get an exception in which case they are elevated to 1B's.

So it would seem like the sensible thing to do would be to stay admitted to the hospital as a 1A, which would increase the odds of getting a heart sooner, right? We had long, long, long conversations between ourselves about whether I should come home or stay in the hospital post-transplant, because we thought it was an option. Brennan, sensibly, argued that I'd have to wait several months to be re-listed anyway, so I might as well be home during that time, then get re-admitted when I was re-listed. That was the plan (though, to our surprise, I was re-listed within weeks of the surgery). Makes sense, except according to insurance, as long as my PT/INR is reasonably stable and there are no other complications, there is no medical reason for a TAH patient to be admitted to the hospital. They won't pay for it. But the reason they take this stance is because by their rules, TAH's are the same thing as LVADs. 

Obviously TAH's need their own classification with OPTN and the insurance industry. But think about this for a moment: I am insured by the very facility that implanted the TAH device, yet they have no separate classification for it. That's how new this is.

The medical/science aspect of the TAH is wonderful. I'm lucky to be alive, and so grateful that this technology even exists. But it comes with many challenges that are frustrating, maddening at times. Five years from now, most of these issues will be resolved, but they are definitely things for the future TAH patient to be aware of. We weren't. Hopefully, our experience helps to prepare those of you considering a TAH down the road. All of this is workable, but it takes work, a lot of time on the phone, pushing, prodding, and arguing at this point in time. The great hope is that the medical and insurance industry will catch up with the technology soon, and none of it will be an issue anymore. Until then, there are a lot of Signs.