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Biotech United States Science

FDA Rejects Artificial Heart 207

Posted by timothy from the stagnation-safer-than-progress dept.
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."
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FDA Rejects Artificial Heart More

FDA Rejects Artificial Heart

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  • I wonder if some side effects could be (Score:5, Funny)

    by ZombieChiefExecutive ( 892832 ) on Saturday June 25, 2005 @06:33PM (#12911195) Journal
    psychological. Imagine walking around knowing you had no heart? Spooky.
    • Brings a new meaning to calling somebody a heartless bastard, doesn't it?

    • Re:I wonder if some side effects could be (Score:4, Funny)

      by CardiganKiller ( 854899 ) on Saturday June 25, 2005 @06:40PM (#12911233)
      If you're so freaked out about not having a heart, the inhabitants of Munchkin Land will have some solid advice for you.
    • 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 (Score:5, Informative)

        by albeit unknown ( 136964 ) on Saturday June 25, 2005 @07:24PM (#12911392)
        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.
        • 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.

          Fair enough, but you can usually get a similar effect by doing a BiVAD type approach. (in the less common situation where the right heart is failing).

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

          You are a bovine?

          -b
        • One interesting thing about this heart described by the ABIOMED page is that it appears totally self contained. No wires through the skin, no air pump console. 1/2 hour internal battery and 4 hour external batteries.

          Could a non-pulsatile version be made using an impeller that would eliminate pulse-shakes and give inhumanly steady hands for microsurgeons and snipers?

          Plug your microsurgeon into a wall outlet via the transcutenous energy transmission coil and they could operate pulse free all day. Likewise

    • Even worse... (Score:5, Interesting)

      by ImaLamer ( 260199 ) <john.lamar@NospaM.gmail.com> on Saturday June 25, 2005 @07:00PM (#12911323) Homepage Journal
      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... (Score:4, Informative)

        by Ritz_Just_Ritz ( 883997 ) on Saturday June 25, 2005 @08:29PM (#12911617)
        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,

        • Re:Even worse... (Score:2, Interesting)

          by Dun Malg ( 230075 )
          I'm sure you can't find the article because it probably doesn't exist. Artificial hearts (and the associated machinery) are quite noisy.

          The article does exist-- I remember it. The guy with the artificial heart didn't actually comment that the lack of noise, but rather that the lack of a pulsing sensation was eerie. This makes more sense anyway, because you can't really hear your heart beat under normal circumstances anyway.

        • Re:Even worse... (Score:2, Informative)

          by modecx ( 130548 )
          No kidding, I know a guy with an artificial valve. It's noisy as hell. I can hear it from 6-8 feet away in an office setting. Then again, I can hear an analog wristwatch in the same environment.. That's the main reason I don't wear a watch around anymore, it's damned annoying.

          Hope I don't have some kind of Captain Hook syndrome going on. Eck!

      • Re:Even worse... (Score:2, Informative)

        by MConlon ( 246624 )
        Your brain does a good job of filtering out continuous (or anticipated) background noise, including a heartbeat. It's similar to the upside-down world experiments where they have people wear CCD glasses which present an inverted image of the world around them... the brain adjusts for the new reality. (And, in fact, you'd be sending a right-side-up image to the optic nerve, because what it sees is inverted/mirrored. Push your eye in the bottom left; watch black spot appear top right.)

        Either way, these d

    • Re:I wonder if some side effects could be (Score:5, Informative)

      by InterGuru ( 50986 ) <[moc.liamg] [ta] [urugretni]> on Saturday June 25, 2005 @10:07PM (#12911969)
      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.
    • Who says you'd have no heart? Just keep it in a jar someplace, problem solved.

  • Setback? (Score:5, Insightful)

    by Nasarius ( 593729 ) on Saturday June 25, 2005 @06:36PM (#12911208)
    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.

    • Re:Setback? (Score:4, Informative)

      by ImaLamer ( 260199 ) <john.lamar@NospaM.gmail.com> on Saturday June 25, 2005 @06:51PM (#12911288) Homepage Journal
      Actuall, looking at TFA you see that it hasn't been totally rejected yet:

      Slashdot title:
      FDA Rejects Artificial Heart

      Washington Post title:
      FDA Panel Rejects Artificial Heart

      In article text:
      the panel voted 7-6 that the heart's probable benefit didn't outweigh the risks ... The FDA is not bound by its advisers' recommendations but usually follows them

      There is still hope, and writing a letter to people like Tom DeLay or George Bush might help (only in that they may get together and pressure the FDA). Kinda ironic that I might actually take their side on this sort of issue - assuming that they would support it due to their right to life/culture of life stance.
      • News moves at such a slow rate on this site, that it's often aliased against other sites, losing details..

        Still a good site for discussion, however.
      • So what you're really saying is that Slashdot has the same editorial standards as the Washington Post...:)

      • Hope??? (Score:4, Insightful)

        by cahiha ( 873942 ) on Sunday June 26, 2005 @04:14AM (#12913129)
        There is still hope, [...] assuming that they would support it due to their right to life/culture of life stance.

        And why would that be "hope"? Why would you place your uninformed judgement, or that of DeLay or Bush, above that of people who have studied the data, know medicine, and have thought about this long and hard?

        Implanting an artificial heart in a sick patient is a painful, dangerous, and costly procedure with (apparently, according to the panel) little benefit to either the patient or research. Those are just the facts of life: as it is, the technology isn't ready. Therefore, it doesn't make sense to subject patients to it, and we can save more lives by spending the money on other procedures.

        When companies come up with devices that do work, then they will get approved. And they can still implant new designs as experimental devices.
    • I was wondering the same thing. In science negative results are just as important as positive ones.

  • Why? (Score:5, Interesting)

    by TheGavster ( 774657 ) on Saturday June 25, 2005 @06:37PM (#12911211) Homepage
    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.
    • Comment removed based on user account deletion

      • Re:Why? (Score:2, Informative)

        by Anonymous Coward
        Actually, there are several strains of HIV, and newer research is showing that the possibility of getting more than one is extremely severe.

        Also, it may be for the safety of medical personel, as harvesting and working with such organs may be more dangerous in some situations (situations that shouldn't come up anyway, but people like to have mulitple security levels).
      • because no system is 100% secure, and even with a 0.001% failure rate, that means SOMEONE is gonna end up with a HIV-sufferers organ, and that's not an acceptable risk

      • Re:Why? (Score:4, Insightful)

        by StrawberryFrog ( 67065 ) on Saturday June 25, 2005 @06:48PM (#12911271) Homepage Journal
        yeah, that reminds me also how they wont transplant an organ from an HIV infected person into another HIV infected person who needs an organ... wtf??

        Two reasons
        - Safety of the people and equipment that will come into contact with the infected blood during the procedure.
        - There's more than one strain of HIV. Having two of them is worse than having one.
    • We aren't talking about bringing back 110 year old people from near death. A lot of children are running around with defective hearts and middle-aged people running around that had poor health education in their younger years. Of course, letting people with "defective" organs die and not reproduce is another argument/fight altogether.

      You are right - if you only have one option: DEATH - then you should be able to take any chance at avoiding death you want. I mean, heart surgery is pretty common today. When

      • Re:Why? (Score:3, Informative)

        by jfengel ( 409917 )
        We aren't talking about bringing back 110 year old people from near death.

        In this case, it's precisely what we're talking about. Abiomed was applying for a "humanitarian device exemption", to be used only in cases where the person had less than a month to live. They weren't expecting you to live long on it; just long enough to say a few extra months of goodbyes.

        They were rejected anyway. The numbers were just too much against them. Two people out of 17 died almost immediately.

        The rejection was narrow,
        • Actually, the FDA hasn't totally rejected the use of the device yet (as I already pointed out [slashdot.org]).. but otherwise you are very correct. At that point I misread the article.

          I don't see the problem if someone makes a conscious decision to use this or any other device. If some people want the right to die, then others should have the right to live.I argue constantly with my friend who is fresh out of medical school (and pretty close to Kevorkian's views medically/politically speaking) - but he always seems to ar
          • I don't entirely understand why the FDA doesn't just say all bets are off once you've got less than a month to live. I mean, have some opium; what, you're gonna get addicted? Disconnect the oxygen and have another cigarette.

            It's true that they haven't rejected it yet. They usually take the advice of the committee; but they rejected the committee's advice on Plan B a few months ago, so who knows? Besides, with a 7-6-1 committee decision, it was hardly a strong recommendation against (especially since I'
            • There is one key reason: charletans. Your chances of survival go way up in that last month if you're not deluged by fake treatments, all of which have no chance *at all* at working, especially if you like your heirs.

              There needs to be a "legitimate experimental" category, where the FDA says that a treatment probably won't help you, but there's a genuine chance it could, and even if it doesn't the experiment will benefit the next guy.
        • In many cases, the cost of this treatment will be paid for by US taxpayers. Spending hundreds of thousands of dollars to keep someone alive an extra month strikes me as being hard to justify when those dollars could be spent extending lives by decades.
      • Running?

        They wouldn't be doing much of that with a bad heart, would they?

    • Re:Why? (Score:5, Insightful)

      by kaiser423 ( 828989 ) on Saturday June 25, 2005 @06:45PM (#12911258)
      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.
    • If the average recipient is estimated to have a year to live and people who receive the artificial heart live an average of 3 months immobilized in excruciating pain... I could see it getting shot down then... although I'm not sure it is the government's place to make that decision.

    • Re:Why? (Score:2)

      by mgv ( 198488 ) *
      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.

      Actually, the decision is based on cost per year of life saved. The magic figure in the US is about $50000 per year of life saved. If it costs more than this its much less likely to get approval. Th
    • It isn't exactly as bad as I you think it is. Int his case, the FDA shot down this thing moving on in terms of acceptability. You actually still might get your hands on one of these devices, but you would get it as a part of a study.

      I am not saying the FDA isn't slow. However, when it comes to life and death your options really open up. If you have tried all the approved treatments then generally you just move on to the 'studies' and 'trails'. In other words, you move onto the very high risk treatment
    • but not all that bad when faced with certainty of death.

      We are all faced with "certainty of death". There are some tradeoffs we can make between comfort and quantity, but just because you are willing to accept an extreme amount of discomfort (think "medieval torture") for a small increase in quantity doesn't mean that that's the decision society has to bless or pay for.

      Furthermore, these devices are hugely expensive. The $500k that are spent to extend the life of 10% of the recipients by 6 months need

  • no heart (Score:2, Funny)

    by ASLayerAODsk ( 893192 )
    so does that mean, 'no heart, no soul'?

  • Most of the recipients in really bad shape (Score:3, Interesting)

    by giminy ( 94188 ) on Saturday June 25, 2005 @06:41PM (#12911235) Homepage Journal
    I heard a report on this earlier in the week on NPR. The interview [npr.org] (sorry, RealAudio is the only option for listening to the report) seemed to indicate that all the recipients up to this point had really really serious health problems besides just having bad hearts. I wonder what choice someone has if they are deemed too unhealthy/high risk for a heart transplant? Sit and wait to die? Serious bummer...

  • Life prolonging (Score:2, Informative)

    by Thomas DM ( 895043 )
    The source claims the heart has been tested by 14 men. Two died directly, one never regained consciousness, ten died within five months and one died after 17 months.

    It costs $250,000 and at best it gives the patients a few months extra life. I believe it should be approved, but only if the patient wants to take the risk and pay for it.

  • Not such a bad thing... (Score:4, Insightful)

    by BTWR ( 540147 ) <americangibor3@ya[ ].com ['hoo' in gap]> on Saturday June 25, 2005 @06:46PM (#12911260) Homepage Journal
    I'm doing my cardiology clerkship for medical school right now, and I can say that although it does suck that this is being rejected, and yes - the US's FDA is notoriously stricter than other countries (certain great chemotherapy drugs are only available to europeans), sometimes this is a good thing. Famously, some years ago the FDA was a little reluctant about this miracle drug sweeping across europe. Turns out that this miracle drug ("Thalidomide" [fda.gov])caused babies to be born without limbs. Yeah - sorta bad. So, it's like an innocent-until-proven-guilty system. Sure, we miss nabbing a lot of criminals, but, the tradeoff is that this system is ultimately made with the idea that it's very hard for an innocent person to be convicted.
    • Here are the true facts of the thalidomide case. It wasn't that the FDA heroically saved us from thalidomide. It was bureaucratic bungling.
    • The US was certainly fortunate to be spared the horrible results of Thalidomide. But the stricter rules in the US have (rough estimate) caused hundreds of thousands of premature deaths, not to mention untold suffering.

      The problem with comparing this to an "innocent until proven guilty" legal system is that with such a legal system the government is refraining from doing harm. In the case of the FDA their are interfering in private choices about medical care and killing more people than they save.
      • killing more people than they save

        This is a ridiculous statement, because there's no reasonable way to evaluate its truth. The FDA delays good drugs, but it also filters out the bad ones. There's no way to differentiate between good and bad without doing sufficient studies. Patients and doctors making "private choices" without enough trials are making uninformed, dangerous choices.

        I'm sorry, but I'm sick and tired of the Libertarian "abolish the FDA" mantra.

        • I'm sorry, but if I'm 3 days away from death, I'll fuckin' try anything that I can goddamn find.

          If I had the chance to either A. die, or B. take a radically new therapy that WILL cure my ailment but whose side effects are not known, I'm taking choice B. If the chemo drugs that cured my cancer caused my kidneys to fail, I'd rather be going to dialysis three times a week than be dead.

          "Dangerous" is subjective. You might find rolling a car dangerous, I'd find it a thrill.

        • Re:Not such a bad thing... (Score:4, Insightful)

          by praksys ( 246544 ) on Saturday June 25, 2005 @09:13PM (#12911730)
          This is a ridiculous statement, because there's no reasonable way to evaluate its truth.

          Sure there is. You take the drugs that were approved ealier in the EU. Figure out how many the bad ones would have killed in the US had they been approved at the same time, then figure out how many the good ones would have saved had they been approved at the same time, then calculate the difference. It's been done, and I'm afraid the result is that the FDA is one of the leading causes of death in the US (same ball park as automobile accidents - tens of thousands of people a year).
          • ou take the drugs that were approved ealier in the EU. Figure out how many the bad ones would have killed in the US had they been approved at the same time, then figure out how many the good ones would have saved had they been approved at the same time, then calculate the difference.

            Medical Research 101: You can't compare the effects of 2 drugs on 2 different populations. Take a homogeneous population of sweeden, with very similar eating habits, genetic patterns, weather, environment, water sources, pollu

            • Medical Research 101: You can't compare the effects of 2 drugs on 2 different populations.

              Pfft - nonsense. If that were true it would be impossible to do drug trials at all.

              I agree that such studies can be done (using european data), but NO respectible peer-review journal would take up a study like the one you suggested.

              Slashdot is peer reviewed, but not respectable, so I figured I could leave out some of the details.

            • Study methodology (Score:3, Interesting)

              by Lonewolf666 ( 259450 )
              OK, remove the 30% of hispanic, black, and asian from your study, and you have a population whose genetic makeup is quite close to the EU.
              In terms of diets and exercise habits, I think the differences are small enough - both EU and USA are industrial countries with similar culture (lots of mutual influences).
              I guess doing such a study is easier than you suggest.
    • It is true that the FDA's prudency has been good in certain cases, but the FDA's rejection of Thalidomide was something of luck. It turned out that the lady who was in charge of evaluating Thalidomide had refused to pass any drug or device whatsoever -- that is, she pretty much said no to anything. Did this lady's conservatism save lives? Yes. Overall was she responsible? Not completely.
    • My grandmother took Thalidomide for a time in the 1950's and it has been assumed that is the reason my uncle sufferes from Meniere's disease...

      http://en.wikipedia.org/wiki/Meniere's_disease [wikipedia.org]
    • Seems more of a guilty-until-proven-innocent system.

    • IIRC, Thalidomide was delayed for use in pregnant women in the US because it was feared to induce abortions. It turned out to do the opposite, it was an anti-abortifactant (and teratogenic as well. A bad combination.)

      Thalidomide was never actually denied approval, though. No decision had been made, and the need for one was pre-empted by the occurance of numerous birth defects in Europe.
    • it does suck that this is being rejected, and yes - the US's FDA is notoriously stricter than other countries

      I think that's more myth than fact. There are many drugs and devices available in the US that are banned or restricted in Europe. Each country just seems to have its own set of hangups about what it permits and what it doesn't permit.

      If the US actually were stricter, it's also unclear that that would be a good thing. In many cases, the decision should be up to the doctor and patient.
    • Turns out that this miracle drug ("Thalidomide")caused babies to be born without limbs.
      So, I'm not a fetus. /Dick Solomon

  • AbioCor Heart: Time Invention of the Year (2001) (Score:3, Informative)

    by reporter ( 666905 ) on Saturday June 25, 2005 @06:47PM (#12911266) Homepage
    You might find the story on the "Time Magazine" website [time.com] to be interesting. Apparently, "Time Magazine" had selected the AbioCor artificial heart (produced by AbioMed) to be the 2001 invention of the year.

    Nonetheless, the real answer to the organ replacement problem is goading adult stem cells into growing a human heart. It would not suffer the negative effects of rejection (caused by donor hearts) and blood clots (caused by mechanical hearts).

  • Ah! (Score:2, Funny)

    by Bad Vegan ( 723708 )
    That explains that whole General Grevious thing.

    I was wondering why he was built like a toaster except for the gizzards.

    - This was a manually created sig. Take THAT robot overlords. -
  • Those people who fear cyborgs can rest easy.

    Motoko Kusinagi [www14.big.jp] is unimpressed with these pathetic, childish attempts at so-called "cyborg" technology.
  • Crap! I better cut back on my drinking. I was counting on that artifical liver 20 years from now.... well there's always stem cells to hope for.

  • Comment removed (Score:5, Informative)

    by account_deleted ( 4530225 ) on Saturday June 25, 2005 @07:16PM (#12911365)
    Comment removed based on user account deletion
    • Since you seem to know about these things- Why does it have to be continuous flow? If we can make an artificial heart that runs constantly, why can't we make one that turns on and off once every second or so?
      • Startup and shutdown are the periods of lowest efficiency and with the highest chance of failure. I had a fan, it was running for about a week straight, the other day I turned it off for a while, then it wouldnt start back up, even with manual assistance. Its a lot easier to start something up and keep it running than to be constantly spinning it up and down. But yes, nobodys really sure of the complications that could arrise from living without a pulse, besides you know, sucking blood or eating brains...

  • Just don't... (Score:3, Funny)

    by SenorAmor ( 719735 ) on Saturday June 25, 2005 @07:19PM (#12911373)
    ... piss off a Naussican, and you have nothing to worry about.
  • Now the researchers and developers who created this have to do more now to make it successful and profitable, instead of just doing what they've done so far and leaving it like that. I wouldn't call a forced "Make it better" a setback. And this signals to others that they have to do a better job to get their stuff approved in the future.

    Still, I can't wait until the world of shadowrun, at least the tech stuff. ;) Where's my damn datajack, cyberdeck, cybereyes, and sleep regulator?
  • If that is the case, and their only choice is to die, screw the FDA..

    I can see an issue if its NOT the last resort. But if this is the last and only way to stay alive, i dont think the FDA has any right to say no.

    Besides, if they wont approve it, another country will. And we miss out on yet another medical advancement..
  • it does seem like a setback towards replacing failing organs with fully artificial ones

    I wouldn't look at it as a setback. A bigger setback would be hundreds of people dying from heart implants that weren't quite ready for the market, and a public afraid to use future implants as a result.

  • I'll tell you why it failed to pass the FDA... (Score:4, Interesting)

    by goldragon ( 170416 ) on Saturday June 25, 2005 @09:07PM (#12911711)
    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 [worldheart.com] 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 [worldheart.com] 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...
  • The FDA stated that there was too little gain

    Like avoiding death?

    with too many adverse side effects.

    Like, er, death?

  • This article explains a bit more about the CEO's explaination for what happened and what he hopes to happen for the future. An important note is that without this artificial heart all of the test subjects would have died slowly one organ failing at a time in a hospitol. The artificial heart allowed one patient to move back home. While others were allowed leave briefly for out of hospitol visits. Two died on the operating table. 42% eventually died from stroke. The reason why they died of stroke is because

  • yes... (Score:2)

    by isny ( 681711 )
    But did it run Linux?
    Commence comments stating, "of course not, it ran Windows!"
  • Versus death? Come on guys... have a heart!
  • Will someone please tell me how an artificial heart qualifies as either a Food or a Drug?

    Or, for that matter, how we ever allowed a single organization to both regulate distribution of broadcast frequencies *and* broadcast content? (FCC)

    Solomon Kevin Chang
  • I was cheering for Robert Tools but it looks like his experience was by far the best of the lot.

    Is a simple mechanical explanation of their mediocre results applicable? Put a new pump in a rotten circulatory system and some pipes are certain to explode into strokes? If so, the whole concept really does need refinement. It could be argued that there are otherwise healthy people who could benefit but how many people with a stake through their heart survive long enough to do the switch?

    I'm sure there are

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