FDA Rejects Artificial Heart

Mad_Rain writes "Those people who fear cyborgs can rest easy. The Food and Drug Administration voted to reject Abiomed's request to sell artificial hearts to people who have suffered heart failure and exhausted their treatment options. The FDA stated that there was too little gain with too many adverse side effects in the limited trial run (17 people underwent the procedure). Although this isn't quite the same product mentioned in previous Slashdot coverage, it does seem like a setback towards replacing failing organs with fully artificial ones."

Comments

I wonder if some side effects could be

[ZombieChiefExecutive]

psychological. Imagine walking around knowing you had no heart? Spooky.

Re:I wonder if some side effects could be

[CardiganKiller]

If you're so freaked out about not having a heart, the inhabitants of Munchkin Land will have some solid advice for you.

Re:I wonder if some side effects could be

[mgv]

Imagine walking around knowing you had no heart? Spooky.

Actually, you generally don't have your own heart taken out for these devices. Instead it is placed alongside your normal heart.

This has the advantage if you have some cardiac reserve that even if the device fails you don't necessarily die, as your own heart may have enough strength to keep you alive till the problem is fixed.

Your heart can actually recover if given a "rest" by these devices, which is another reason to not take it out. These devices have a strong role to play in end stage heart failure when there is a prospect of recovery.

Also, this is only one of many devices being trialled. I have been involved with many assist devices and some of them are more promising than the abiomed. I think that we will be seeing alot more of them in the future. I personally* know of one person in our unit who went nearly two years on a similar device whilst awaiting a heart transplant.

Michael

* For what its worth, I am an anaesthetist who works in a heart transplant unit, and we use these things alot - the surgeons put them in at the business end, but we run the controls on the slightly less biological end of things. I guess its something like IAACA (I am a cardiac anaesthetist).

Re:I wonder if some side effects could be

[albeit unknown]

You are describing a Left Ventricular Assist Device (LVAD). That's not what this is.

The Abiomed device is a Total Artificial Heart (TAH). They cut out your existing left and right ventricles and install this in their place. If the device fails, you die instantly.

For what it's worth, I participated in the first calf trial of this device at Louisville.

Re:I wonder if some side effects could be

[InterGuru]

I have a spooky side effect from my implanted mechanical mitral valve. Whenever it is quiet I hear a steady click-click as my heart beats, one click for each beat. People with good hearing can hear it a short distance away. This really startled my 16 year old nephew who heard it as we were working a computer together. I'm sure he has spread the story among his friends.

I find the clicking sound reassuring, it is a sign that everything is working well.

While valve and my pacemaker (which gives no sign of its presence) is comforting for me, I hear that others are disturbed as they make them feel not whole and reminds them of thier mortality.

A psychotherapist friend of mine tells me that he has a patient being driven crazy by the clicks. I feel sorry for the patient, as there is no way to avoid them.

Setback?

[Nasarius]

it does seem like a setback towards replacing failing organs with fully artificial ones

How so? It just means that they'll have to improve their technology first. That doesn't seem like a setback to me.

Why?

[TheGavster]

I never understood 'cure for death' type devices getting shot down. Like, your heart is going to stop and you will die, but we could perform $risky_medical_proceedure and there's a 10% chance you'd live. That's pretty lousy survival for say, cough drops, but not all that bad when faced with certainty of death.

Re:Why?

[kaiser423]

Basically, it's the public and perception.

Lots of lawsuits from people who "didn't fully comprehend all the risks", hospitals, doctors, procedures getting the labeled as killers, and having bad track records. Malpractice for relatively safe procedures is astronomical. No one wants to deal with those doctors (aka "so, 75% of your surgeries end up in death, why should I work with you?").

Money. That's a lot of money in the surgery for a small chance of living.

This isn't so much people banning it though. Believe me, there's tons of new, exciting, dangerous surgeries abound. The test for this heart had 17 patients with those types of risks. There's lots of cutting edge research looking for people in the exact scenario you describe, and they usually get some for of radical new treatment. In this case, the FDA just decided that this radical new treatment hadn't matured enough yet. So, there will be a couple more studies where people can get artificial hearts if they really need them.

Basically, the FDA doesn't like to make radical treatments mainstream. It prefers to keep them in the research wings where people who need them can get them, but to keep mainstream procedures as safe and mundane as possible.

Even worse...

[ImaLamer]

Can't find the article now, but people who lived in the trials had something very spooky happen once their new "hearts" were installed - their life became really quiet.

Usually you don't notice your heartbeat, or have other things going on to drown out the noise. But with an artificial heart, you aren't spending as much time in bars and so forth - you get more quiet time. The man who lived the longest compained that once the artificial heart was installed he could no longer hear the beating of his heart and it was eerie. The heartbeat is something every human knows, and many cultures have played on it in their music (trance, drums).

So yes it is spooky, but for more problematic reasons. It just needs a virtual drum machine or something...

Re:Even worse...

[Ritz_Just_Ritz]

I'm sure you can't find the article because it probably doesn't exist. Artificial hearts (and the associated machinery) are quite noisy. As a matter of fact, artificial heart valves, which are quite common, are noisy enough that you can hear them from several feet away in a quiet room. I have an artificial valve and it sometimes keeps me awake at night. It's like having an old school wind-up wrist watch parked next to your ear. But it certainly beats the alternative....death. Cheers,

Not the only device...

[Achra]

As has been mentioned, this _is_ a bit of a step backward. However, the Abiomed device is an actual artificial heart.. This is much more complicated than the accepted alternative, the left ventricle assist (LVAS). The idea is, they stick this motor in the side and bottom of your heart, and turn it on. No chambers required, no pulse necessary. Constant Flow. Makes me wonder how well the brain would operate without a pulse though.. Would it effect your moods? I'm not sure, but as this is a press release, I don't _think_ it violates my NDA. http://www.terumo.co.jp/English/press/2004/04_01.h tml/

I'll tell you why it failed to pass the FDA...

[goldragon]

it's right here in the article text...

sufferers... are likely to die within a month

I am a biomedical engineer for Cardiology at a top 25 hospital in the US, and a trained LVAS engineer for the WorldHeart Novacor LVAS system. We see 3-4 implants a year with this system*. The patients who are referred for implant come in literally with one foot over the threshold of death. It's amazing any of them survive the surgery at all. Doctors are scared to death of the devices. We have had attendings refuse to admit a patient once they learned the patient had a LVAD. Yes, some of the side effects can be severe. You have about as great a chance of dieing from a stroke caused by a massive clot in the device as you do of heart failure, but the reason to take that risk is quality of life. This man here is one of our patients. He has been on pump for four years this month. That's four years of quality life, enjoying his grand- and great grandkids. Hell, we have photos of him putting a roof on his barn while standing in the front end loader on his tractor. Our other patients go back to work, or at least can live on their own in their home, without 24/7 nursing care or constant hospital stays like patients who do not get a pump.

These devices are mostly used for "bridge to transplant" meaning it is used to keep them alive and healthy until hopefully they get a heart transplant. Unfortunately there are like 2,000 donor hearts a year and 50,000 people who need one. So many of these companies are aiming to be certified "destination therapy" which means the person gets a pump and that's it. If/when it wears out, they get a replacement, but they won't get a donor heart. Which is fine, because the patients who get donor hearts are back constantly for biopsies and caths to check that their donor heart is healthy (since only arteries/veins get connected between the person and donor heart and not nerves, they can't feel chest pain if they have a heart attack) and are on anti-rejection medication regimens.

* - Our hospital also does the Abiomed AB5000 and Thoratec HeartMate, but these are short term (days to weeks) support devices where the patient does not leave the hospital and are supported by the Perfusion team (the people who run the heart/lung bypass machines during surgery). The Abiomed device sits on the freakin' outside of your body and it's clear so you watch your own blood pump through it. It's actually clear so the clinician can look for a "flash" which is when the device completely empties of blood after a stroke and you see the white membrane inside. The console used during surgery is roughly the size of a dishwasher and the "travel console" is like a piece of carryon luggage. The Thoratec HeartMate I is approved for destination therapy, but we don't use it as such. Their HeartMate II is going into clinical trial, and is totally implantable. Hopefully it will pass the FDA's approval for destination therapy and we can save 48,000 lives a year...