X-Message-Number: 16114
From: Mgdarwin@cs.com
Date: Tue, 24 Apr 2001 01:29:07 EDT
Subject: Kryos News # 1

Kryos, Inc. News #1

We Have Ignition

Work has begun at the building Kryos recently leased, to put in place the 
plumbing and wiring infrastructure necessary to support a human 
cryopreservation operation. The building is already nearly ideally subdivided 
and is fully sprinklered. It was built to the most recent seismic code 
revision for Southern California (which is the most rigorous in the United 
States). We anticipate that it will take approximately a month for the many 
parts of infrastructure to be put in place. We have been very fortunate that 
the 
building was extensively wired for both standard electrical service (with 
many outlets in each room) and is fully LAN ready. This saves us a great deal 
of expense and time as every room is wired for the Internet and several rooms 
have floor embedded electrical outlets.

If we experience no substantial delays we should be operational at a
pre-21st Century Medicine (21CM) level of service in 3 to 4 months. We may
initially offer vitrification using non-21CM technology (i.e., no ice
blockers). We anticipate this situation will be temporary, but it will take
time and money to tool for 21CM technology and some potential patients may
not be able to wait that long. We have urged these individuals to contract
with Alcor, but they have chosen not to. For the record, I am signed up with
Alcor and plan to remain so until other competent people are on-line. We
want to make very clear that people should not delay making cryopreservation
arrangements for trivial reasons. Especially if you are risk you should make
arrangements promptly. While Kryos will be focusing partially on at-need
cases, we would much rather one of these cases not be you!

Currently, only Alcor has access to 21CM vitrification technology. We believe 
that for anyone dying now this technology represents such a Quantum advance 
that there simply is no comparison. That is one of the reasons we are so 
eager to get to the point where Kryos can offer it. We think that will happen 
late in July or early in August if all goes well.


The Total Artificial Heart
by Mike Darwin

A major focus of Kryos is to rapidly get whole body vitrification to the 
point where we are causing at most trivial biochemical and modest membrane 
changes to the brain and the body exclusive of the visceral organs. 

If we can limit the type of injury we do to relatively modest changes which 
foreseeable 
biotechnology can reverse, then a significant subset of patients being 
cryopreserved today could be recoverable within twenty to thirty years. 
Clearly, extending vitrification to include the whole body will be a priority 
as well, and we understand that a major undertaking in this area is planned 
for launch during the next year. However, achieving simultaneous 
cryopresrervation of all the visceral organs (as opposed to the nervous 
system, sense organs and skeletal muscle) will be more challenging.

The question thus becomes "How will it be possible to recover someone who has 
suffered freezing damage to critical body organs?" The answer is: "Replace 
them." For some organs such as the liver this will be a tall order, and 
cryonics related research on cryopreservation should focus on these organs 
first.

For others, such as the heart, even current biomedical technology is probably 
equal to the task of replacement. Sometime in the next week or so the first 
completely implantable total artificial heart (TAH) will be placed in a 
patient in the US who has a prognosis of less than 30 days to live. The 
device will be manufactured by Abiomed, (http://www.abiomed.com/)
a leading left ventricular assist device (LVAD) company. LVADs are 
used to temporarily support failing hearts as a bridge to transplant or to 
allow the heart to "heal" itself in an unloaded condition.  

No doubt many of you are shaking your heads at the notion of a workable TAH 
given the dismal record of the Symbion Jarvik hearts. The sad truth is 
that a workable TAH technology has been in existence for nearly a decade. The 
principal reasons the TAH has not been exploited has been resistance by the 
Federal Government both in the FDA and at higher levels over concerns related 
not only to device efficacy, but more importantly over concerns related to 
the impact 
a successful TAH would have on the Federal healthcare budget. The Abiomed 
heart, if mass produced, would probably cost no more than $75,000 to implant 
(including hospital stay). That is roughly the cost of two coronary artery 
bypass operations. The problem for the government and private insurers is 
that there are easily 250,000 candidates for the TAH and the costs are not 
confined to the heart or the surgery. In fact, saving those lives means lots 
of extra expense in the form of lab tests, medical follow up, medications to 
slow the progression of atherosclerosis in organs, and so on. And, ultimately 
of course, people with TAHs will die of other far more costly diseases than 
heart attacks or congestive heart failure. Indeed, the only way most of these 
people will "die" is if the signal is given to turn the TAH off!

Abiomed is pursuing their pilot TAH program in a highly structured way which 
I have great admiration for. First, they have incrementally advanced the 
technology demonstrating very long service life in animals without the 
complications the Jarvik heart caused (blood cell damage, clot formation and 
infection at the drive line entry/exit site). Second, they have eliminated 
the hard 
mechanical valves commonly used to replace failing human valves and which 
have been exclusively used in all previous TAHs. Instead they have used the 
technique developed by Wilhem Kolff of using injection molding to create soft 
valve leaflets coated with antithrombogenic material. The valves are 
essential an integral part of the heart and should not shed stroke-causing 
clots into the circulatory system. Third, they have developed a completely 
implantable heart with no external wires, drive lines or cables thus 
eliminating the formerly intractable problem of infection at the entry 
site(s) for these invasive appliances. Fourth, they have imposed a complete 
blackout on all media coverage of the implants for 30 days following the 
first one. After that, clinical details will be released, but not necessarily 
the identity of the patient. This should avoid the celebrity effect and the 
media vulture gathering which acompanies it. 

Abiomed has permission to implant only 5 TAHs in this trial. The FDA has set 
the bar very high for Abiomed in no small measure because they do not want 
this technology to succeed. Despite this, Abiomed may prevail. They have 
enlisted some of the best centers of medical excellence in the US to do 
conduct their trial; UCLA is one of them.

The take-home message here is that TAH technology has been not only possible 
but feasible in the animal lab for at least a decade. The only barriers to 
application of this technology have been regulatory and financial (the 
insurance companies don't want to pay for it and most Americans don't want to 
pay for it in the form of higher healthcare insurance premiums).

A final lesson from the TAH story, however it turns out, is that just because 
something is technologically possible, and not even more expensive than many 
other technologies in wide use in the same area, doesn't mean it will be 
used. Part of Kryos' mission will be to help make you and the public at large 
of these kinds of glitches in the progress of biomedicine where they may 
critically limit the speed with which we can achieve reversible human 
cryopreservation. Watch the Abiomed trials closely. If they are successful 
think about putting the pressure on the various special interest groups that 
may make demand for them impossible to refuse. The cost of the Osprey 
Helicopter would have paid one year of the TAH program in the US. 

The choice seems simple: a military helicopter which doesn't work or a heart 
that does.

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