X-Message-Number: 1390 Date: 03 Dec 92 06:54:37 EST From: Paul Wakfer <> Subject: CRYONICS: Freezing Damage (Darwin) Part 2 Perfusion Perfusion of both groups of animals was begun by carrying out a total body washout (TBW) with the base perfusate in the absence of any cryoprotective agent. In the FGP group washout was achieved within 2 - 3 minutes of the start of open circuit asanguineous perfusion at a flow rate of 160 to 200 cc/min and an average perfusion pressure of 40 mmHg. TBW in the FGP group was considered complete when the hematocrit was unreadable and the venous effluent was clear. This typically was achieved after perfusion of 500 cc of perfusate. Complete blood washout in the FIGP group was virtually impossible to achieve (see "Results" below). A decision was made prior to the start of this study (based on previous clinical experience with ischemic human cryonic suspension patients) not to allow the arterial pressure to exceed 60 mmHg for any significant period of time. Consequently, peak flow rates obtained during both total body washout and subsequent glycerol perfusion in the FIGP group were in the range of 50-60 cc/min at a mean arterial pressure of 50 mmHg. Due to the presence of massive intravascular clotting in the FIGP animals it was necessary to delay placement of the atrial (venous) cannula (lest the drainage holes become plugged with clots) until the large clots present in the right heart and the superior and inferior vena cava had been expressed through the atriotomy. The chest was kept relatively clear of fluid/clots by active suction during this interval. Removal of large clots and reasonable clearing of the effluent was usually achieved in the FIGP group after 15 minutes of open circuit asanguineous perfusion, following which the circuit was closed and the introduction of glycerol was begun. The arterial pO2 of animals in both the FGP and FIGP groups was kept between 600 mmHg and 760 mmHg throughout TBW and subsequent glycerol perfusion. Arterial pH in the FGP animals was between 7.1 and 7.7 and was largely a function of the degree of diligence with which addition of buffer was pursued. Arterial pH in the FIGP group was 6.5 to 7.3. Two of the FIGP animals were not subjected to active buffering during perfusion and as a consequence recovery of pH to more normal values from the acidosis of ischemia (starting pH for FIGP animals was typically 6.5 to 6.6) was not as pronounced. Introduction of glycerol was by constant rate addition of base perfusate formulation made up with 6M glycerol to a recirculating reservoir containing 3 liters of glycerol-free base perfusate. The target terminal tissue glycerol concentration was 3M and the target time course for introduction was 2 hours. The volume of 6M glycerol concentrate required to reach a terminal concentration in the recirculating system (and thus presumably in the animal) was calculated as follows: Vp Mc = --------- Mp Vc + Vp where Mc = Molarity of glycerol in animal and circuit. Mp = Molarity of glycerol concentrate. Vc = Volume of circuit and exchangeable volume of animal.* Vp = Volume of perfusate added. * Assumes an exchangeable water volume of 60% of the preperfusion weight of the animal. Glycerolization of the FGP animals was carried out at 10*C to 12*C. Initial perfusion of FIGP animals was at 4*C to 5*C with warming (facilitated by TBW with warmer perfusate and removal of surface ice packs) to 10*-12*C for cryoprotectant introduction. The lower TBW temperature of the FIGP animals was a consequence of the animals having been refrigerated on ice for the 24 hours preceding perfusion. Following termination of the cryoprotective ramp, the animals were removed from bypass, the aortic cannula was left in place to facilitate prompt reperfusion upon rewarming, and the venous cannula was removed and the right atrium closed. The chest wound was loosely closed using surgical staples. Concurrent with closure of the chest wound, a burrhole craniotomy 3 to 5 mm in diameter was made in the right parietal bone of all animals using a high speed Dremel "hobby" drill. The purpose of the burrhole was to allow for post-perfusion evaluation of cerebral volume, assess the degree of blood washout in the ischemic animals and facilitate rapid expansion of the burrhole on rewarming to allow for the visual evaluation of post-thaw reperfusion (using dye). The rectal thermistor probe used to monitor core temperature during perfusion was replaced by a copper/constantan thermocouple at the conclusion of perfusion for monitoring of the core temperature during cooling to -79*C and -196*C. Cooling to -79*C Cooling to -79*C was carried out by placing the animals within two 1 mil polyethylene bags and submerging them in an isopropanol bath which had been precooled to -10*C. Bath temperature was slowly reduced to -79*C by the periodic addition of dry ice. A typical cooling curve obtained in this fashion is shown in Figure 5. Cooling was at a rate of approximately 4*C per hour. Cooling to and Storage at -196*C Following cooling to -79*C, the plastic bags used to protect the animals from alcohol were removed, the animals were placed inside nylon bags with draw-string closures and were then positioned atop a 6" high aluminum platform in an MVE TA-60 cryogenic dewar to which 2"- 3" of liquid nitrogen had been added. Over a period of approximately 48 hours the liquid nitrogen level was gradually raised until the animal was submerged. A typical cooling curve to liquid nitrogen temperature for animals in this study is shown in Figure 6. Cooling rates to liquid nitrogen temperature were approximately 2*C per hour. After cool-down animals were maintained in liquid nitrogen for a period of 6-8 months until being removed and rewarmed for gross structural, histological, and ultrastructural evaluation. Rewarming The animals in both groups were rewarmed to -2*C to -3*C by removing them from liquid nitrogen and placing them in a precooled box insulated on all sides with a 2" thickness of styrofoam and containing a small quantity of liquid nitrogen. The animals were then allowed to rewarm to approximately -20*C, at which time they were transferred to a mechanical refrigerator at a temperature of 8*C. When the core temperature of the animals had reached -2*C to -3*C the animals were removed to a bed of crushed ice for post-mortem examination and tissue collection for light and electron microscopy. A typical rewarming curve is presented in Figure 7. Modification of Protocol Due To Tissue Fracturing After the completion of the first phase of this study (perfusion and cooling to liquid nitrogen temperature) the authors had the opportunity to evaluate the gross and histological condition of the remains of three human cryonic suspension patients who were removed from cryogenic storage and converted to neuropreservation (thus allowing for post-mortem dissection of the body, excluding the head) (10). The results of this study confirmed previous, preliminary, data indicative of gross fracturing of organs and tissues in animals cooled to and rewarmed from -196*C. These findings led us to abandon our plans to reperfuse the animals in this study with oxygenated, substrate-containing perfusate (to have been followed by fixative perfusion for histological and ultrastructural evaluation) which was to be have been undertaken in an attempt to assess post-thaw viability by evaluation of post-thaw oxygen consumption, glucose uptake, and tissue-specific enzyme release. Rewarming and examination of the first animal in the study confirmed the presence of gross fractures in all organ systems. The scope and severity of these fractures resulted in disruption of the circulatory system, thus precluding any attempt at reperfusion as was originally planned. Preparation of Tissue Samples For Microscopy Fixation Samples of four organs were collected for subsequent histological and ultrastructural examination: brain, heart, liver and kidney. Dissection to obtain the tissue samples was begun as soon as the animals were transferred to crushed ice. The brain was the first organ removed for sampling. The burrhole created at the start of perfusion was rapidly extended to a full craniotomy using rongeurs (Figure 8). The brain was then removed en bloc to a shallow pan containing iced, modified Karnovsky's fixative containing 25% w/v glycerol (see Table I for composition) sufficient to cover it. Slicing of the brain into 5 mm thick sections was carried out with the brain submerged in fixative in this manner. At the conclusion of slicing a 1 mm section of tissue was excised from the visual cortex and fixed in a separate container for electron microscopy. During final sample preparation for electron microscopy care was taken to avoid the cut edgdes of the tissue block in preparing the Epon embedded sections. The sliced brain was then placed in 350 ml of Karnovsky's containing 25%w/v glycerol in a special stirring apparatus which is illustrated in Figure 9. This fixation/deglycerolization apparatus consisted of two plastic containers nested inside of each other atop a magnetic stirrer. The inner container was perforated with numerous 3 mm holes and acted to protect the brain slices from the stir bar which continuously circulated the fixative over the slices. The stirring reduced the likelihood of delayed or poor fixation due to overlap of slices or stable zones of tissue water stratification. (The latter was a very real possibility owing to the high viscosity of the 25%w/v glycerol-containing Karnovsky's.) Deglycerolization of Samples To avoid osmotic shock all tissue samples were initially immersed in Karnovsky's containing 25%w/v glycerol at room temperature and were subsequently deglycerolized prior to staining and embedding by stepwise incubation in Karnovsky's containing decreasing concentrations of glycerol (see Figure 10 for deglycerolization protocol). To prepare tissue sections from heart, liver, and kidney for microscopy, the organs were first removed en bloc to a beaker containing an amount of ice-cold fixative containing 25% w/v glycerol sufficient to cover the organ. The organ was then removed to a room temperature work surface at where 0.5 mm sections were made with a Stadie-Riggs microtome. The microtome and blade were pre-wetted with fixative, and cut sections were irrigated from the microtome chamber into a beaker containing 200 ml of room-temperature fixative using a plastic squeeze-type laboratory rinse bottle containing fixative solution. Sections were deglycerolized using the same procedure previously detailed for the other slices. Osmication and Further Processing At the conclusion of deglycerolization of the specimens all tissues were separated into two groups; tissues to be evaluated by light microscopy, and those to be examined with transmission electron microscopy. Tissues for light microscopy were shipped in glycerol- free modified Karnovsky's solution to American Histolabs, Inc. in Rockville, MD for paraffin embedding, sectioning, mounting, and staining. Tissues for electron microscopy were transported to the facilities of the University of California at San Diego in glycerol- free Karnovsky's at 1* to 2*C for osmication, Epon embedding, and EM preparation of micrographs by Dr. Paul Farnsworth. Due to concerns about the osmication and preparation of the material processed for electron microscopy by Farnsworth, tissues from the same animals were also submitted for electron microscopy to Electronucleonics of Silver Spring, Maryland. ***Electronucleonics results are not covered here since another investigator has yet to provide the necessary information and we do not have access to the pictures. III. EFFECTS OF GLYCEROLIZATION Perfusion of FGP Animals Blood washout was rapid and complete in the FGP animals and vascular resistance decreased markedly following blood washout. Vascular resistance increased steadily as the glycerol concentration increased, probably as a result of the increasing viscosity of the perfusate. Within approximately 5 minutes of the beginning of the cryoprotective ramp, bilateral ocular flaccidity was noted in the FGP animals. As the perfusion proceeded, ocular flaccidity progressed until the eyes had lost approximately 30% to 50% of their volume. Gross examination of the eyes revealed that initial water loss was primarily from the aqueous humor, with more significant losses from the posterior chamber of the eyes apparently not occurring until later in the course of perfusion. Within 15 minutes of the start of glycerolization the corneal surface became dimpled and irregular and the eyes had developed a "caved-in" appearance. Dehydration was also apparent in the skin and skeletal muscles and was evidenced by a marked decrease in limb girth, profound muscular rigidity, cutaneous wrinkling (Figure 11), and a "waxy- leathery" appearance and texture to both cut skin and skeletal muscle. Tissue water evaluations conducted on ileum, kidney, liver, lung, and skeletal muscle confirmed and extended the gross observations. Preliminary observation suggest that water loss was in the range of 30% to 40% in most tissues. As can be seen in Table III, total body water losses attributable to dehydration, while typically not as profound, were still in the range of 18% to 34%. The gross appearance of the heart suggested a similar degree of dehydration, as evidenced by modest shrinkage and the development of a "pebbly" surface texture and a somewhat translucent or "waxy" appearance. Examination of the cerebral hemispheres through the burr hole (Figure 12) revealed an estimated 30% to 50% reduction in cerebral volume, presumably as a result of osmotic dehydration secondary to glycerolization. The cortices also had the "waxy" amber appearance previously observed as characteristic of glycerolized brains. The gross appearance of the kidneys, spleen, mesenteric and subcutaneous fat, pancreas, and reproductive organs (where present) were unremarkable. The ileum and mesentery appeared somewhat dehydrated, but did not exhibit the waxy appearance that was characteristic of muscle, skin, and brain. Oxygen consumption (determined by measuring the arterial/venois difference) throughout perfusion was fairly constant and did not appear to be significantly impacted by glycerolization, as can be seen Figure 12. Perfusion of FIGP Animals As previously noted, the ischemic animals had far lower flowrates at the same perfusion pressure as FGP animals and demonstrated incomplete blood washout. Intravascular clotting was serious a barrier to adequate perfusion. Post-thaw dissection demonstrated multiple infarcted areas in virtually all organ systems; areas where blood washout and glycerolization were incomplete or absent. In contrast to the even color and texture changes observed in the FGP animals, the skin of the FIGP animals developed multiple, patchy, nonperfused areas which were clearly outlined by surrounding, dehydrated, amber-colored glycerolized areas. External and internal examination of the brain and spinal cord revealed surprisingly good blood washout of the central nervous system. While grossly visible infarcted areas were noted, these were relatively few and were generally no larger than 2 mm to 3 mm in diameter. With few exceptions, the pial vessels were free of blood and appeared empty of gross emboli. One striking difference which was consistently observed in FIGP animals was a far less profound reduction in brain volume during glycerolization (Figure 13). This may have been due to a number of factors: lower flow rates, higher perfusion pressures, and the increased capillary permeability and perhaps increased cellular permeability to glycerol. Whereas edema was virtually never a problem during glycerolization of FGP animals, edema was universal in the FIGP animals after as little as 30 minutes of perfusion. In the central nervous system this edema was evidenced by a "rebound" from initial cerebral shrinkage to frank cerebral edema, with the cortices, restrained by the dura, often abutting or slightly projecting into the burrhole. Marked edema of the nictating membranes, the lung, the intestines, and the pancreas was also a uniform finding at the conclusion of cryoprotective perfusion. The development of edema in the central nervous system sometimes closely paralleled the beginning of "rebound" of ocular volume and the development of ocular turgor and frank ocular edema. In contrast to the relatively good blood washout observed in the brain, the kidneys of FIGP animals had a very dark and mottled appearance. While some areas (an estimated 20% of the cortical surface) appeared to be blood-free, most of the organ remained blood- filled throughout perfusion. Smears of vascular fluid made from renal biopsies which were collected at the conclusion of perfusion (for tissue water determinations) revealed the presence of many free and irregularly clumped groups of crenated and normal-appearing red cells, further evidence of the incompleteness of blood washout. Microscopic examination of recirculating perfusate revealed some free, and a few clumped red cells. However, the concentration was low, and the perfusate microhematocrit was unreadable at the termination of perfusion (i.e., less than 1%). The liver of FIGP animals appeared uniformly blood-filled throughout perfusion, and did not exhibit even the partial blood washout evidenced by the kidneys. However, despite the absence of any grossly apparent blood washout, tissue water evaluations in one FIGP animal were indicative of osmotic dehydration and thus of some perfusion. The mesenteric, pancreatic, splanchic, and other small abdominal vessels were largely free of blood by the conclusion of perfusion. However, blood-filled vessels were not uncommon, and examination during perfusion of mesenteric vessels performed with an ophthalmoscope at 20X magnification revealed stasis in many smaller vessels, and irregularly shaped small clots or agglutinated masses of red cells in most of the mesenteric vessels. Nevertheless, despite the presence of massive intravascular clotting, perfusion was possible, and significant amounts of tissue water appear to have been exchanged for glycerol. One immediately apparent difference between the FGP and FIGP animals was the accumulation in the lumen of the ileum of large amounts of perfusate or perfusate ultrafiltrate by the ischemic animals. Within approximately 10 minutes of the start of reperfusion, the ileum of the ischemic animals that had been laparotomized was noticed to be accumulating fluid. By the end of perfusion, the stomach and the small and large bowel had become massively distended with perfusate. Figure 14 shows both FIGP and FGP ileum at the conclusion of glycerol perfusion. As can be clearly seen, the FIGP intestine is markedly distended. Gross examination of the gut wall was indicative of tissue-wall edema as well as intraluminal accumulation of fluid. Often by the end of perfusion, the gut had become so edematous and distended with perfusate that it was impossible to completely close the laparotomy incision. Similarly, gross examination of gastric mucosa revealed severe erosion with the mucosa being very friable and frankly hemorrhagic. Escape of perfusate/stomach contents from the mouth (purging) which occurs during perfusion in ischemically injured human suspension patients did not occur, perhaps due to greater post-mortem competence of the gastroesophageal valve in the cat. Oxygen consumption in the two ischemic cats in which it was measured was dramatically impacted, being only 30% to 50% of control and deteriorating throughout the course of perfusion (Figure 12). Rate This Message: http://www.cryonet.org/cgi-bin/rate.cgi?msg=1390