Saturday, July 21, 2007

Rapid Cooling in Cryonics

The protocols regarding the rate of cooling have been debated amongst prominent researchers interested in hypothermic techniques, for many decades, with no clear answer. What is known is that rapid cooling and/or warming can lead to gaseous emboli, and that maintaining a temperature gradient of 10°C, or less, during the cooling of human patients provides a proven margin of safety. Cardiac surgeons truly hate the time spent waiting for the patient to be cooled and rewarmed. If they could shorten this time by using rapid cooling, they certainly would, yet the 10°C safety margin is adhered to in heart surgery, all around the world.

I employed hypothermic techniques on an almost-daily basis, for many years, cooling most patients to 28 - 32°C. I also participated in a significant number of profound hypothermia cases, where our patients were cooled to below 18°C and then exsanguinated. I saw the vast majority of our patients wake up, neurologically intact. Some of them had minor neurological deficits that turned out to be transient. Would they have had any benefit from being cooled more rapidly? It's doubtful. Would they have suffered greater cerebral injury if cooled rapidly. I believe that's probable.

Yes, the risk of micro-air emboli is greater with rapid warming than rapid cooling, but warming and cooling always take place at the same time. While the heat exchanger in the perfusion circuit is cooling the patient, the patient functions as a heat exchanger, warming the perfusate that comes to the body, and vice versa.

In Dr. Harris' June 22, 2007 "Great Expectations" post on the Cold Filter Forum, he stated, "I do not believe you will find any support in the literature for your contention that too-rapid cooling is to be avoided while on bypass. But I could be wrong, so show me."

For Dr. Harris to have not ever seen any literature supporting the avoidance of too-rapid cooling on bypass, he must not have looked, at all. It's out there, and it's plentiful. Here are just a few examples:

The Manual of Clinical Perfusion
Second Edition Updated
By Bryan V. Lich, CCP and D. Mark Brown, CCP

If cooling is used a temperature gradient less than 10°C between the arterial and venous blood is maintained. This prevents the formation of microbubbles. (Page 75.)


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University of Michigan Medical Center
C.S. Mott Children’s Hospital
Protocols and Guidelines for Pediatric Perfusion

Upon initiation of CPB, the perfusionist cools the patient maintaining an 8 - 12°C temperature gradient between the perfusate and rectal and/or nasopharyngeal temperature whichever is highest. This technique avoids the generation of gaseous emboli when the solubility in the blood of atmospheric gases is lowered by excessive rewarming of the perfusate in the tissue.
http://www.amsect.org/pediatric/protocols/mott.pdf (Page 59)

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Myocardial Protection and Cardiopulmonary Bypass
CARDIOPULMONARY BYPASS

1. The Circulatory Environment


B. Heat exchanger· The cooling or warming gradient is usually within 10-14 degrees of the patient’s temperature· This minimizes the tendency for gas to come out of solution and risk of air embolism· Mixed blood temperature should be less than or equal to 38.5C· The water bath should stay between 15 and 42C to prevent organ damage (too cold) and hemolysis (too warm)
Maintain a gradient of 4-6C, as rapid cooling produces uneven cerebral cooling
http://www.ctsnet.org/doc/2220

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From Ben Best’s Website:

Cell survival generally drops to zero for cooling rates that are either too rapid or too slow, giving an "inverted U curve". Excessively fast cooling rates kill cells by osmotic damage to membranes caused by pressure & friction from the exiting water molecules. Or excessively fast cooling allows for formation of ice inside cells -- which is far more damaging than extracellular ice. There is evidence that plasma membrane damage due to excessive osmotic pressure creates holes in the membrane allowing ice to form intracellularly [
BIOPHYSICAL JOURNAL; Muldrew,K; 66(2 Pt 1):532-541 (1994)]. If cooling is too slow, however, cells will be killed either by prolonged exposure to the toxic concentrations of electrolytes that form outside the cell or by mechanical crushing from extracellular ice.
http://www.benbest.com/cryonics/cooling.html (Note: The link to the Muldrew paper is incorrect; here’s a new link to that article: http://www.biophysj.org/cgi/reprint/66/2_Pt_1/532 )

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Cerebral consequences of hypothermic circulatory arrest in adults.

EB Griepp, RB GrieppDepartment of Cardiothoracic Surgery, Mount Sinai Medical Center, New York, New York 10029.

“At present, risk factors associated with less favorable cerebral outcome after HCA include: prolonged duration of HCA (usually greater than 60 min); advanced patient age; rapid cooling…”
http://www.ionchannels.org/showabstract.php?pmid=1606366 (HCA = hypothermic circulatory arrest)

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Australia and New Zealand College of Perfusionists
Notes in Clinical Perfusion

Hypothermia & CPB
rate of cooling & warming and the effect on monitored temperatures

Temperature management entails 3 principles:
1) During both cooling & rewarming a maximum of 10°C is maintained between the water temperature (of the heater-cooler) and the blood temperature

a)Too rapid cooling may be associated with cerebral injury [eg cerebral vasoconstriction may be associated with reduced uniform cooling of brain)

b)Too rapid rewarming may be associated with the danger of gas bubble formation as gases become less soluble in blood as temperature increases + critical post ischaemic period characterised by high cerebrovascular resistance -impaired autoregulation & high cerebral metabolic demand for oxygen

2)Secondly, once the desired patient temperature has been reached, a further 10 minutes at least is required at this temperature to allow for uniform cooling of brain when cooling & uniform warming of body when rewarming

3) Once on HCA, must reduce rewarming-maintain hypothermia: use cooling blanket
· Is important to ensure cooling is not done too rapidly and once have reached target temperature a further interval of cooling is achieved prior to circulatory arrest to allow for uniform cooling of the brain and other vascular organs
http://www.perfusion.com.au/CCP/Details%20in%20perfusion%20technique/Hypothermia%20&%20CPB.htm

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The effect of cooling rate during perfusion on function and morphology of rabbit kidney grafts.
Jacobsen IA, Chemnitz J, Kemp E, Buhl MR.

"The effect of cooling of rabbit kidneys during the initial flush with Collins' solution for simple hypothermic storage was studied. After cooling at an average rate of 3.7 degrees C/min. graft function was found to be immediately life-sustaining, and renal morphology after perfusion as well as 30 min. and 24 hours posttransplant was found to be normal. Posttransplant function after cooling at a rate of 7.2 degrees C/min. was significantly lower, permitting survival of only 30% of recipient animals, and damage was seen in proximal tubular cells."
PMID: 7013052 [PubMed - indexed for MEDLINE]

(My note: In summary, faster cooling rates led to cellular damage and lowered survival rate.)

I understand that rapid cooling may be an "necessary evil," in regard to the vitrification process, as the solutions being used are more toxic at higher temperatures. However, I question the wisdom of rapid cooling during the washout procedure, while the patient has either blood or the biocompatible washout solution in their circulation. I've seen many patients wake up, neurologically intact, after being cooled to clinical death, below 18°C, and left that way for a period of time. I think it's reasonable to assume a patient could slowly be cooled to near zero, for the washout procedure, with the same amount of safety.

I may be wrong, but I don't believe it will ever be proven that rapid cooling to near zero C is as safe, or safer, than adhering to the proven safety guidelines that were established in surgical hypothermia protocols, long ago. I'm still concerned when I see Platt's statements about the cooling abilities of his "Liquid Ventilation" system on the Suspended Animation web site: “Typically a descent from 25 degrees Celsius (78 Fahrenheit) to 3 degrees celsius (37.4 Fahrenheit) takes less than five minutes. The system is then ready for use."

Does this mean they are applying this technique to a still warm patient when the liquid is at 3°C? Is it wise to flush fluid at 3°C into a patient at near 37°C, (using their lungs as a heat exchanger and greatly exceeding the 10°C safety gradient). There are studies that indicate rapid cooling may not be as damaging as it has been thought to be, but is it worth the risk at this point in time? Cardiac surgeons and perfusionists all around the world think it is not. Does Charles Platt even care? Or is he just interested in as many design and fabrication hours as he can get and taking credit for the design of new equipment, no matter how ill-advised?

I do think the idea of using lung lavage for initial cooling of cryonics patients could be of value when it is not possible to immediately place the patient on bypass. However, I think the cryonics protocols for cooling AND post-ischemic oxygenation, (another topic I will address, soon, on this blog), via lung lavage/liquid ventilation, should be more carefully examined.

Tuesday, July 17, 2007

SA's Failure to Deliver Promised Services

My main purpose in going online with my criticisms of Suspended Animation has been to make the public aware of the failure of that organization to deliver what they have promised to the cryonics community, in spite of having had five years time, and a rather large sum of money at their disposal. My postings on the "Cold Filter" forum have been more emotionally charged than I would have liked them to have been, but I hope the readers will realize that my frustration and anger developed over a period of ten months of trying to politely convince Charles Platt to reconsider the equipment and medical protocols of SA, a company that has been under his guidance for the last three years.

Unless I were to suggest something that included a large number of design and fabrication hours for Charles, every suggestion was met, first with a myriad of invalid excuses and arguments, and later by subversive tactics designed to exclude me from the projects, even when they were related to perfusion technology, my field of expertise. The best example of this is the level detector debacle, in which I estimate Platt paid himself tens of thousands of dollars, over the course of a year, or more, to design and build his own level detectors, when he was fully aware FDA-approved detectors were available for $385.

Charles never even looked at the medical detectors, designed specifically for monitoring the level of a perfusion reservoir, even though Mathew Sullivan had suggested the same model I suggested, a year earlier, before Charles started on his own design. His design never functioned properly, even after a year, but he still wanted to continue working on them. SA could have purchased one of the FDA-approved medical devices for every eight-hour day Charles worked on his own.

In the end, he was so determined not to use the medical devices Mathew and I had recommended, he abandoned his original design, sought out a cheap industrial sensor and conspired with one of his fabricators to modify it without even discussing it with anyone else. As I told them both, at the time, I am always willing to consider alternatives to my suggestions, even in regard to perfusion circuits, but for the two of them to order and test perfusion devices, without including me in this decision, was way out of line. They should have just come to me and said, "Hey, Mel, we found this sensor that costs a lot less than the ones you suggested," and I would have done what I did anyway, suggest we test the two models side-by-side, as Gary and I did. The cheap industrial sensors performed very poorly in comparison to the medical-grade sensors, and they would have required Charles to build alarm boxes for them, a project he had been unable to successfully complete in a year's time. Gary apologized to me for this fiasco, but to this day, Charles insists on pretending I took the more expensive route because it "looked" better, a ridiculous assessment of the situation.

Though it may not be clear to Saul Kent, there is no doubt in my mind that Charles Platt operates primarily in his own best interest. From his own mouth I have that he was allowed to bill up to $8,000 a month to SA for his "consulting" hours. (He was the acting manager, regardless of his title.) He was also receiving $500 a month for his Florida apartment, and a third party, in Arizona, was being paid $100 a month to babysit his cat, a cat that Steve Harris claims to have in California. In addition, Charles was paid for his work on the SA website, whether directly, or indirectly through his girlfriend. Even his most devoted followers at SA often accused him, (behind his back), of billing SA for management hours and web design hours, at the same time. The SA web design contract is with a partnership owned by Platt and his girlfriend, not his girlfriend, alone, as he led others to believe. I believe they received a rather healthy lump sum for the initial design of the site, plus unlimited hours to be paid to them for writing, photography and maintenance.

Charles defended this nepotistical contract to me by saying Bary Wilson had contracted with EN, (Platt's girlfriend), to build and maintain the website. Everybody at SA knows Bary did not want to contract with EN. In fact, the conflict over the design of the website was probably the beginning of the end, at SA, for Bary. Charles also said EN "had been Saul's friend, for years." This doesn't prove she is competent; it only supports the accusation of nepotism. Finally, Charles said EN had been "a successful web designer for ten years." If that was the case, why was not one page of the web site uploaded in the three months following the signing of the contract? When I complained to Charles that no work had been done on the website, he said, "I know, it should have been finished two months ago." A few weeks later, EN was at the facility, sitting at a desk adjoined to Charles' and the website started appearing. It was obvious, to everyone, that Charles, not EN, was building the web site, and most of the employees thought he was billing SA for management hours and web design hours, at the same time. Further evidence that EN is not likely to be a "successful web designer with ten years of experience" is her own web site that has never been completed. (See: http://endesigns.com/.) The SA website has not been completed, to this day, and it hasn't been properly updated, since well before the May conference.

Only three "insiders" in cryonics have disagreed with my opinion that Platt is in it for the money. One of them is Saul Kent who seems to think Charles could make a lot more money as a writer, but that's unlikely to be true. Not many writers earn six figures a year. I think Charles is certainly capable of writing a big-seller, but he seems to prefer the easy money he gets from LEF, to writing. His recent magazine articles certainly could never support him in the style he's become accustomed to, at SA. The other two insiders who told me they didn't think he was in it for the money, (they most likely don't realize just how much money we're discussing), said he was in it for egotistical purposes. One of them said he likes being a "big fish in the small sea" of cryonics.

In regard to his writing, his recent article in "Make Magazine" features photos of an SA staff member, using the SA facility and tools, to build a plastic desk set. I tend to believe no one was clocking out, for these photo shoots. I know a lot of the work and discussion on Platt's previous "Make" article on another SA employee's dog biscuit throwing machine took place during SA work hours, because I was there. Platt's "Make" LED lighting article gives some insight as to why thousands of dollars for man-hours were spent installing the extremely strange lighting in the SA Dodge Sprinter. All those tiny little LEDs were hand-soldered in position, and then additional lighting had to be installed, because the LED lighting was inadequate, as anyone should have been able to predict. Why didn't SA just purchase and install the proper lighting, to begin with? It would have been a lot faster, and a lot less expensive. Perhaps this what happens when you have a creative person, with no medical background, and being paid an obscene hourly rate, making decisions.

Charles Platt hand-picked the current staff members of SA, set the salaries, and requested frequent raises for them. With the exception of cryonicist Mathew Sullivan, whom Charles has tried to get rid of on numerous occasions, the staff members do not have medical, or cryonics, backgrounds. Other than Mathew, I don't think any of them even care about cryonics. Charles has set the salaries of these individuals, most of whom would probably earn in the $20-40K range, at $60-80K. In addition they get four weeks of vacation a year, some other minor benefits, and the freedom to come and go from the facility, as they please. They may not like to think of it this way, but I believe Platt has been buying their loyalty, (not to the company, but to himself). For a person like Charles, who has a limited understanding of medicine, the best way to maintain power in a company that offers medical services is obviously to surround yourself with people who don't know even as much as you do, and overpay them.

Why has a company, whose goal was to provide the best cryonics "standby, stabilization, and transport" services in the land, spent three years and millions of dollars on building the Rube Goldberg-esque designs of a science fiction writer when existing medical equipment can be adapted for a lot of cryonics purposes? Why does that company employ three highly-paid fabricators to build Platt's designs, and not one solitary medical professional, after five years' time? Why do experienced managers, such as Bary Wilson, and experienced medical professionals, such as myself, not last long at Suspended Animation?

SA recently sent a young woman who had never performed ANY medical procedure more complicated than applying a BandAid, and had no cryonics experience, to function as the "Team Leader" on one of their cases. They also sent along two fabricators, who had no prior medical or cryonics experience. One of these people is someone I have heard say to his visiting father, "You have to be careful what you say around here, (the SA facility), Dad, some of these people actually believe in this crap." These people do not care about cryonics. They have just been doing whatever Platt tells them, without question, and making possibly the best money they will ever make in their lives.

I don't know how anyone, especially Saul Kent, can look at the evidence and still allow Charles Platt to influence the decisions made at SA. I'm seriously concerned that Charles Platt will "help" Saul Kent choose a new manager for Suspended Animation. I have no doubt he is sitting in on every interview, and has some degree of input. If that is the case, I believe there are three possible outcomes:

1. The new manager of SA will not have enough knowledge of existing medical procedures, technologies and equipment, to question the projects at SA, and will become another "Platt Puppet." If this is the case, the facility will continue to exist, primarily, for the fabrication of Platt’s designs, and little will be accomplished. They need to focus on their goal of providing the best standby, stabilization and transport possible, and put everything else aside, until they achieve that one goal. It's unreasonable for anyone to believe the current grossly underqualified staff of SA is capable of coming online with vitrification, or anything else, for that matter. Yes, they're all nice people, but what does that really mean to the company, or their clients???

2. Platt will find a more qualified person who will eventually recognize the lack of progress, but will keep their mouth shut because they need the generous salary Platt will undoubtedly negotiate for them.

3. The new manager will have enough knowledge, and be ethical enough, to question Platt’s inevitable “guidance,” and gross overspending on Platt's projects, and will either be fired, or pushed into resignation, as Bary and I were. If this happens, Platt will have yet another opportunity to resume control of SA. At this point, he will no doubt continue to lament about how much he really wants to get away, but there's just nobody in the world capable of replacing him. If nothing else, maybe my rants on Cold Filter and on this blog will make it difficult for Saul Kent to allow SA to continue under the corruption of Charles Platt.

Unlike Platt and Harris would have us believe, it is not impossible to establish teams of qualified personnel for cryonics standby, stabilization and transport. Just because they don't know how to go about it, doesn't mean it can't be done. Unlike me, they don't know dozens upon dozens of surgeons, perfusionists, physician assistants, and surgical nurses. Platt has not even tried to find qualified standby team members. He just takes on any soul he meets who happens along with an interest in cryonics and an admiration for Platt, himself. He took on the EEII paramedics that were already working with Alcor, and then did virtually nothing to expand or improve, the SA standby team. (He will say he found me, but the truth is, I found them, quite by accident.) The contracts he wrote for the EEII paramedics are grossly inadequate. That company receives a monthly retainer for providing a list of ten paramedics interested in cryonics cases. These ten people receive a fee about three times the average hourly pay of a paramedic, to attend the infrequent SA training sessions, at which most of their suggestions are ignored. The contracts Platt wrote for them allows them to turn down cases, when they are called out. In other words, not one medical professional is guaranteed to show up for a case, in violation of SA's contract with their clients, as pointed out by FD on the Cold Filter Forum. I firmly believe that, with far less than half of SA's annual budget, a strongly qualified standby team and the proper equipment could be established and maintained. It's time for a gross overhaul of SA, and in my opinion, the first step should be for LEF to cut all ties with Platt and find a REAL manager and some qualifed personnel.

Below is a reprint of one of my first posts to the Cold Filter cryonics forum:


$1.2 Million a Year for Standby, Stabilization and Transport

May 22, 2007 at 10:06 AM

Melody (Login melmax)Registered User
Adapt existing, proven medical equipment for cryonics stabilization purposes. This does not require an 8,000-square-foot facility, or six-to-eight full-time employees who, for the most part, know absolutely nothing about medicine. It requires someone who understands both cryonics and traditional stabilization medicine well enough to know what has already been done, and can build on that. The fabrication work can be contracted out; it doesn’t require three highly-paid full-time employees. People who do not have experience in emergency medicine or heart surgery may not realize exactly how similar cryonics procedures are to more conventional procedures that are performed thousands of times a day, all around the world. A lot of the equipment used in these procedures is easily adapted for cryonics purposes. As an example, SA’s current transportable PIB weighs 69 pounds without the legs, and is somewhat difficult for someone who hasn’t had a lot of practice to assemble. I believe SA is on the third version of their PIB, and a fourth is in the works. How much time and money has been spent on the development and fabrication of the PIB? A transport basket such as the one Alcor displayed at last year’s conference weighs less than half as much, costs less than $1,000, and will withstand the weight necessary for cryonics purposes. The adaptation of this type of basket was suggested by paramedics from Dr. Soard’s group, at two of the three SA training sessions I attended. This is just one example; I have similar criticisms of most of the equipment being designed and built at SA.


Establish relationships with companies that can provide emergency stabilization and transport professionals, (such as Dr. Soard’s company), in key locations. With only approximately 30 clients spread out across the country, the choice of locations is a little tricky, but locations near the hubs of the major airlines might be good choices. Store standby, stabilization and transport equipment at these locations. Pay these emergency service providers a fee for storing the equipment, and a reasonable retainer to provide a guaranteed number of paramedics or EMTs for cases. Contract to pay a generous fee to the EMT’s and paramedics for actual case work. I believe the current individual paramedic/EMT contracts at SA allow them to turn down two out of three call-outs. At the rate cases are being performed, (I believe there’s been one in the last three years), an individual could collect the handsome fees they are paid for the rare training sessions, for a very long time, without ever going on a case. Another possibility might be establishing relationships with private ambulance companies that are located near the clients. I don’t know if this has been explored by SA, but it seems worth looking into.

I’ve yet to figure out why SA has spent hundreds of thousands of dollars on purchasing and modifying two vehicles that won’t ever benefit most of their clients. Unless you live very close to that facility, or have adequate warning of your impending legal death, they are going to fly to your location and pick you up in a rented moving van. Like almost everything else at SA, the vehicles just don’t make sense, to me; they’re just a distraction from the fact that nothing is really being accomplished.Have an experienced mortician, or someone else with experience shipping human bodies, collaborate with some of the scientific experts in cryonics, to establish a sound protocol that complies with airline and DOT regulations, for shipping cryonics patients from the location of their legal death and (hopefully successful) washout procedure, to where they will be vitrified and stored. It doesn’t make sense to have a vitrification facility without a storage facility, (a direction it sometimes seems SA is heading); too many things can happen during transport, and from my brief exploration of transporting at cryogenic temperatures, it seems there are quite a lot of regulations to overcome.

Have a small facility with a business coordinator and a medical coordinator. At least one of these people should have good communication and organizational skills and be capable of managing a small business. This same person should also be capable of doing the bookkeeping, managing the web domain, maintaining the web site, cleaning the office, and gathering and distributing information, because with the lack of a significant number of cases, there’s not much else to do on a full-time basis. (In spite of SA’s rather healthy payroll, they contract out for all these services.) The other person should have a strong emergency medicine background and be capable of working with both medical professionals and experts in cryonics, to establish medically-sound protocols. This person should be responsible for coordinating the standby teams and training sessions, and making sure all the standby equipment and kits are kept up-to-date and uniform. These two people don’t have to be paid two-to-three time what they are capable of earning anywhere else; money may buy loyalty, but it won’t buy sincerity.

The remainder of the $1.2million annual budget, (and that remainder should be substantial), should be spent on research.This is a rather simplistic outline of what I think would be a better course of action for a company that wants to provide standby, stabilization and transport services for cryonicists. I think the greatest need in cryonics, at this point in time, is for a tremendous amount of research to be directed at improving the medications and vitrification solutions, and developing optimal cooldown protocols.