The Rise and Fall of Modern Medicine

by James Le Fanu

  It was obvious, however, that the future could not lie with cross circulation, not least because it exposed the healthy donor to an unacceptable risk (although in fact there had been only one serious complication, where the donor had had to be resuscitated). There was thus no alternative other than to return to the pump, and here Lillehei and Kirklin took separate routes. Kirklin thought the principle behind Gibbon’s pump to be essentially sound and persuaded the Mayo Clinic to invest heavily in modifying and improving it. In the summer of 1954, Lillehei encouraged a young research worker in his department, Richard DeWall, to resurrect an old idea where oxygen was bubbled into the patient’s blood in a reservoir outside the body and then ‘debubbled’ before being returned.23

  The psychological barrier of open-heart operations had now been broken. Equipped with their pumps, Kirklin and Lillehei dominated cardiac surgery for the next ten years. True to form, their initial experiences were disastrous. All of Kirklin’s first five patients died either during or immediately after the operation. Nonetheless, there was a sense that if they persisted it would ‘come right’, and it did. The mortality rate fell rapidly to 50 per cent for the next ten patients, and then to 30 per cent, and within a couple of years it had fallen to single figures.

  It is necessary to appreciate just how ill these children were. Nowadays babies born with Fallot’s are operated on in the first year of life so one no longer sees what Kirklin called the ‘pitiful’ state of those he operated on. It is well illustrated by one of Lillehei’s early cases, a seven-year-old girl whose twin sister had a normal heart. She weighed only 36 pounds compared to her sister’s 56 pounds and her cyanosis – the blue tinge of the skin – was ‘intense’. She was ‘undeveloped and undernourished’ and had recently started having convulsive seizures caused by inadequate oxygenation of the brain. Following her operation ‘her immediate colour change from intensely cyanotic to pink was dramatic’, and by the time she came to leave hospital her clinical appearance was described as ‘normal’.

  It is difficult to imagine how impressive such results must have appeared at the time and, more astonishingly, how consistently they were achieved. In Kirklin’s account of his first seventy operations there is a table listing their subsequent medical conditions. With only very few exceptions it reads: ‘Asymptomatic, full activity.’24

  Soon the repair of Fallot’s Tetralogy became routine, and Kirklin and Lillehei turned their attention to even more complex abnormalities such as repositioning the major arteries as they emerge from the heart. Kirklin subsequently recalled the atmosphere of those days:

  I am very proud for the two of us that during this period when we were the only surgeons in the world to perform open-heart surgery and were thus in intense competition with each other that we continued to communicate and argued over our differences, not publicly, but privately in nightclubs and on aeroplanes. Walt was more optimistic than I when we discussed difficult problems. I remember saying to him one day, ‘Walt, I am so discouraged with complete atrioventricular canal’ [a condition where all four chambers of the heart communicate and where all the patients Kirklin had operated on up to that time had died]. ‘Oh sure,’ he said, ‘that is a tough one, but we will learn to do well with it.’25

  By 1960 they had operated on every single ‘operable’ heart defect in children and turned their attention to replacing diseased valves in adults. Technically these are staggeringly difficult operations, requiring patients to be on bypass for several hours, as the diseased valve has first to be carefully dissected out and the new one sewn into place with hundreds of separate stitches. The results followed precisely the same pattern as the operations in children, with initially a very high death rate of around 90 per cent, either from the operation itself or the failure of the artificial valve to function, as they tore easily and sometimes broke.26 Donald Longmore, of London’s National Heart Hospital, describes the results of these early operations as ‘horrendous’: ‘The commonest post-operative complication was severe multi-organ damage. Moderate cerebral impairment [i.e. brain damage] was for a time almost routine, with cerebral devastation [irreversible brain damage] a frequent occurrence often associated with kidney failure.’27

  No sooner had surgeons resolved those problems associated with valve replacement than some were turning their minds to what is often considered the ‘ultimate operation’, the heart transplant, which was performed for the first time by Christiaan Barnard in 1967.28 This looked as if it might be cardiac surgery’s armageddon, for in the following year 100 transplants were performed across the world and not a single patient survived. In response to these catastrophic results, a moratorium was imposed on further heart transplants, with only one surgeon, Norman Shumway of Stamford University, carrying on in the face of bitter opposition. But within ten years this too had ‘come right’. By the early 1980s 2,000 patients a year in the United States were receiving a heart transplant, with a survival rate of over 80 per cent.

  And for all this, ultimately, Gibbon must take the credit. Before his pump, cardiac surgery was essentially limited to one crude ‘blind’ operation – the dilation of narrowed valves. From 1955 onwards and with increasing competence the surgeons were able to do dozens of different complicated procedures which, by the 1980s, were benefiting tens of thousands of patients every year. No doubt if it had not been Gibbon it might have been someone else, and it is certainly true that there were others involved in building pumps in the late 1940s, notably Viking Bjork in Sweden and Donald Melrose in London. But Gibbon was the first. The challenge he set himself in the 1930s, before he could have imagined what it might lead to, now seems breathtaking. It would be difficult enough to build a pump nowadays from scratch, let alone at a time before the advent of appropriate materials such as plastic and with only derisory funds for medical research. Further, Gibbon and his wife were not only alone, but for the best part of twenty years had to contend with the scepticism, indeed active discouragement, of their professional colleagues, who had no faith that their pump would ever be put to practical use.

  7

  1961: NEW HIPS FOR OLD

  The range of surgery in the post-war years expanded prodigiously with the introduction of ‘mass’ operations, performed in their tens of thousands for the alleviation of the ‘chronic degenerative diseases of ageing’, an ugly term to describe what happens when the tissues of the body are no longer able to renew themselves, so that the lens becomes cloudy with cataracts, or the surfaces of the joints become cracked. These forms of chronic degeneration are important because they diminish function in a way that seriously impairs the quality of life. The obvious solution is some form of ‘spare-part’ surgery where a clouded lens or diseased joint is replaced with an artificial part made of some robust material. But there was a catch. ‘Mass’ problems require ‘mass’ solutions, which require that the technical problems involved in such operations be resolved in such a way that they become straightforward and the results reliable.

  These ‘mass’ operations represented the ‘paradigm shift’ as it applied to surgery, where the historical preoccupation with infectious disease gave way to a preoccupation with age-related chronic disease. Historically, most of the workload of orthopaedic surgeons had involved trying to correct the consequences of chronic infections (such as tuberculosis) of the bones and joints, or the skeletal abnormalities associated with polio. By the early 1960s both problems were fast disappearing and indeed there was much speculation that orthopaedic surgeons might soon become an endangered species, until these new ‘mass’ operations of replacing arthritic joints arrived just in time to save them. Now they have more than enough to be going on with. These operations are so common – 40,000 hip replacements are performed in Britain each year – as to have become routine, but their development required just as much determination – and luck – as any of the other definitive moments.1 There is no better illustration of these matters than the career of John Charnley and the events that led to his singular achievement –
the total hip replacement.

  John Charnley’s hip replacement is, by definition, a successful operation. It is straightforward (the skills can be readily acquired as part of general orthopaedic training), it works, and it lasts. From this one might readily surmise that it is also ‘simple’, but that would be misleading. Certainly the principle appears simple enough – cut away the arthritic hip and replace it with an artificial ball and socket – but ‘the mechanics of the hip joint are so complicated that a satisfying conception is scarcely obtainable’. This complexity arises because the hip joint has to fulfil the apparently incompatible tasks of both sustaining the weight of the body while at the same time being fully mobile.2 Even if the challenge of replicating the remarkable mechanical properties of the hip can be overcome, the problem remains of how to implant it in such a way that it lasts as, not surprisingly, the body does not take kindly to having chunks of metal and plastic inserted into it.

  The underlying problem in arthritis of the hip is the erosion with time of the cartilage that covers both the head of the femur and the cup (or acetabulum) into which it fits in the pelvis, thus exposing the bone underneath. So, instead of two glistening surfaces rolling over each other, bone grinds on bone. The result is a constant and nagging pain much like a toothache, which is often worse at night, making sleeping difficult or impossible, and those with hip arthritis are often described as appearing tired or having a haggard expression. If, as often happens, the arthritis affects both hips, then this alters the biomechanics of the skeleton so the pain radiates up into the lumbar region and down to the knees. Then there is stiffness because, with a painful joint, the surrounding muscle groups go into spasm to limit its movement. The combination of pain and stiffness necessarily limits mobility which, depending on severity, may range from ‘the patient is bedridden and can walk only a few yards with stick or crutches’ to ‘walking limited to less than one hour with a stick’. Arthritis of the hip drags a person down and so destroys the zest for living as to make some suicidal.3

  There are two things that can be done to provide relief from the misery of hip arthritis. The first is to fuse the hip by cutting away the top of the femur and ramming it into the pelvis to form a bony union, as when a fracture heals. This will abolish the pain but necessarily it also abolishes the mobility of the hip. The second possibility is to interpose some material that will reduce the pain by preventing bone rubbing on bone. The femoral head can be cut away and replaced by a metal prosthesis and the pelvic cup can be replaced by one made of plastic. The logical extension of this principle is to replace both surfaces with a total hip replacement or arthroplasty (from the Greek arthro for ‘joint’ and plasty for ‘form’, i.e. the formation of a movable joint).

  From the 1930s onwards many surgeons developed arthroplasty operations, including Marius Smith-Petersen of Boston, who claimed ‘good’ results in half his patients after four years. Philip Wiles of the Middlesex Hospital in London designed a stainless-steel total hip replacement – which he inserted in six patients in 1958 ‘with some degree of success’. Another British orthopaedic surgeon, Kenneth McKee in Norwich, developed a total hip replacement made of cobalt. Then there was the Judet arthroplasty, devised by two brothers, Jean and Robert Judet of Paris, whose initial results were exceptionally good though they did not last. The prosthesis cracked and had to be removed.4

  The prevailing view in the mid-1950s on all these operations was summarised by the opening speaker in a debate – ‘In the opinion of this house, all methods of arthroplasty of the hip have failed to achieve their purpose’ – that took place at the annual meeting of the British Orthopaedic Association in Buxton in 1954.5 He drew attention to four failings: serious post-operative complications; early deterioration; the expense of the seemingly endless physiotherapy subsequently required; and, crucially, ‘the faulty conception of the operation due to ignorance of the true pathology’. The arthroplasty was doomed to failure, he argued, because no one properly understood the biomechanics of the hip. The debate was notable for the intervention of a rising star in the orthopaedic world, 43-year-old John Charnley. A North Country lad, born and bred in the industrial town of Bury where his father kept the same chemist’s shop in the centre of town all his life, Charnley was, according to a friend, ‘very bright, very clever and very good company’. After war service in the Middle East he returned to Manchester to become the protégé of the godfather of British orthopaedics, Professor (Lord) Harry Platt. Small in stature, he was an exact man with what would now be described as elitist views. As for hip replacements, he expressed the opinion in the debate that their record was so poor and unreliable that it was much more sensible – at least from the patients’ perspective – to perform the simpler operation of fusing the hip, which at least was guaranteed to relieve pain, even though it resulted in a stiff leg.6

  Within seven years of Charnley’s intervention in this debate he had made ‘the most significant development in orthopaedics this century’ with a paper published in The Lancet in 1961: ‘Arthroplasty of the Hip: A New Operation’.7 The stimulus that seems to have led him to change his mind and take up the challenge of developing a new hip was the arousal of his intellectual curiosity by a chance observation made by a patient attending his orthopaedic clinic at Manchester Royal Infirmary. This man had had a Judet prosthesis (an artificial head of the femur) inserted elsewhere. He told Charnley that his artificial hip had squeaked so loudly whenever he leaned forward that his wife avoided being in the same room with him whenever possible. The squeak lasted only a few more weeks before disappearing, from which it was only natural to infer that the movement of the artificial hip had become smoother. Charnley, however, drew the opposite conclusion and described his thinking as follows:

  The starting point was the well-known observation that after the Judet operation the hip squeaks. The squeak indicates that frictional resistance to sliding is so high that the surfaces are seizing together. Hence it seemed likely the plastic of the Judet prosthesis had adverse frictional properties when sliding against the bare bone of the arthritic acetabulum. It seemed possible too that the loss of sensation of squeaking might be a sign not of improved lubrication but of loosening of the attachment of the prosthesis.8

  Charnley inferred that if a total hip replacement was to work the frictional resistance between the two components had to be as low as possible. He proceeded to rethink every aspect of the problem, coming up with three brilliant innovations concerned with lubrication of the joint, cementing the prosthesis in place and designing a socket with maximum stability.

  Charnley started by investigating the nature of friction within the normal joint. Frictional resistance occurs when an object is moved tangentially with respect to the surface of another contrary object and is measured as ‘the coefficient of friction’. When experimenting on a freshly amputated knee joint Charnley found this to be quite extraordinarily low, at 0.005 – better than that of a skate sliding on ice. Clearly the friction coefficient in an artificial joint similarly had to be as low as possible. This is best achieved by the juxtaposition of two materials – durable metal for the femoral prosthesis and some slippery substance to replace the damaged cartilage of the acetabulum. Charnley was advised that the recently developed Teflon would be suitable.9

  The femoral prosthesis had to be made of metal if it was to be durable, but this raised the question of how to fix it in such a way that it would not become loose. It was customary to ‘fix’ prostheses with screws, but Charnley came up with an entirely different suggestion which he later described as his ‘most significant breakthrough’10 – the use of acrylic cement. He was not the first to use the material, but the first to understand its properties and how to use it properly. The function of the acrylic cement was not to act as a ‘glue’ to hold the prosthesis in place, but rather as a ‘grout’ transferring the load of the prosthesis over the whole inner surface of the bone. In this way the fixation of the femoral prosthesis was increased by a factor of 200.11
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  Finally, for the hip replacement to be stable the femoral prosthesis had to articulate within its Teflon socket as firmly as possible. Charnley’s brilliant solution was to reduce by an inch both the diameter of the head of the femoral prosthesis and the diameter of the acetabulum cup.12 Thus Charnley’s hip is not so much a replacement as a ‘reconstruction’, in which, in order to ensure maximum stability and range of movement he redesigned nature’s original to take account of the properties of the materials that were being used. The credit was certainly not entirely Charnley’s, and he duly acknowledged the help of his engineering colleagues.

  Charnley’s 1961 paper describing his new operation is a masterpiece of non-technical lucidity. The results after just one year were very encouraging, with grossly disabled patients being able to return home within two months having shown they could ‘walk the length of the ward without sticks and with only a slight limp’.

  And then the following year disaster struck. Some time in 1962 it became clear that Teflon was not a suitable material for the ‘cup’ component of the hip replacement. First, it was simply not tough enough and over a period of three to four years the Teflon lining had almost completely worn away. Second, the minute particles of Teflon generated a severe inflammatory reaction, loosening the cup in the pelvis so the hip became painful again.

  There was no alternative other than to try and repair the damage and, according to one of his assistants, ‘every time he did a revision operation it was like observing a monk pouring ashes over his head’. Charnley’s biographer, William Waugh, describes this difficult period: