In the last week of October 2007, the patients on the heart transplant waiting list at Papworth Hospital received disturbing news in the mail. Papworth, on the outskirts of Cambridge, the venue for the first successful heart transplant in the UK, in 1979, had hit a bad patch. Between January and September 2007, the hospital had carried out 20 heart transplants, and seven patients had died within 30 days. In addition, another patient who had received a new heart in October was in a critical condition and would fail to make it.
The letter to patients on the waiting list explained that all further operations would be suspended until the reasons for what was a dramatic increase had been examined. Nationally, on average, approximately 10 per cent of patients undergoing heart transplants die within 30 days of their operation. At Papworth between January 2004 and December 2006, the 30-day mortality rate had been only 7 per cent. But now something had gone wrong. The hospital's director of transplant services had contacted the National Commissioning Group, the body responsible for overseeing heart and lung transplant services in England. Word reached the Chief Medical Officer, who ordered the suspension of further transplants until the Healthcare Commission could investigate.
The Healthcare Commission called in two consultant cardiac surgeons to help with its inquiry. Papworth was visited three times, 18 staff at the transplant unit and the coroner were interviewed, and records were examined on many aspects of admission, organ retrieval, surgery and post-operative care. (This was familiar territory: a similar investigation had been conducted the previous year into problems connected with Papworth's lung transplants.)
Its initial findings were baffling: surgeons at the hospital carried out about 30 per cent of all heart transplants in the UK, and in 2006 all but three of the 36 patients who underwent heart transplants at Papworth survived. So what dramatic events could explain the recent failures? A report was expected within two weeks, but what would the investigators find in this short period? Would their findings improve the success rate of future transplants? And why would one former member of the Papworth team claim the report was a political whitewash?
What happened at Papworth was a sobering experience not just for the hospital, but for organ transplantation in this country. It shone light on an area of medicine we have come to regard as routine, something we think about only when things go wrong. The reality is different: the failure rate is almost as high as it was 15 years ago; only about half the number of heart transplants are carried out annually compared with the early Nineties; the number and quality of donated organs has declined; and many people still die each year in the UK awaiting surgery. In addition, there are ongoing concerns about the methods used to distribute donor hearts, with competing hospitals worrying that the present system is not only unfair but may also act to the detriment of their patients.
Papworth Hospital is not an ideal place to practise 21st-century medicine. The buildings are made as comfortable as possible for its patients, but what has become the UK's largest specialist cardiothoracic hospital began in 1917 as a local tuberculosis centre. The staff spend some of their day battling the elements as they move outside from their offices to consulting rooms or wards. The site at Papworth Everard, 12 miles west of Cambridge, is also isolated from the town's leading research centres and does not present an attractive job placement for the world's leading specialists. Things will change: in 2012, the hospital is due to move to a new £200m state-of-the-art home on the Cambridge biomedical campus, where it will integrate with Addenbrooke's Hospital and the research facilities of the university.
As a patient with a critical condition, it is fair to assume the age of your surroundings are not of uppermost concern. When Karen Jackson arrived at Papworth for a consultation at the end of 2005, she was impressed with the expertise and directness of the staff. She was 38, and suffering from acute hypertrophic cardiomyopathy, a condition which increases the thickness of the heart wall and inhibits the pumping action.
'I felt drained and shattered all the time,' she says. It was an inherited condition: her mother suffered from it, too, and it killed her when she was 50. Jackson had been aware of her ailment since the age of nine, and it restricted her sporting endeavours, but she managed to live a fairly normal life. She qualified as a solicitor and got married, but her health gradually worsened. By 2005, when her heart went permanently out of rhythm and she had difficulty breathing, her cardiologist described her heart as 'fried', and found the chambers were dangerously out of sync. A pacemaker was fitted to protect her in the event of a heart attack, but a transplant was now her only chance of a long life.
Jackson's assessment at Papworth in December 2005 revealed her heart was operating at 20 per cent of its capacity, and she was put on the waiting list immediately. She was told she may have to wait between six months and a year, but because it was approaching Christmas she possibly stood to benefit from the increased road traffic accidents at this time. She was also told to remain within two hours' drive of her London home. 'Every time the phone rang,' she says, 'it was, "Aargh, this could be it."' By this stage she couldn't do any lifting or carrying, and on some days it was a struggle to get up and shower. 'The hardest thing was, I couldn't read one page of a book. I couldn't remember anything, because I had very little blood flow to my brain.'
After one false alarm, Jackson was called for her transplant in June 2006. She was one of the lucky ones. When she'd recovered from the operation, a surgeon told her she had received one of the healthiest young hearts he'd ever harvested. But her recovery was tricky. She was at Papworth for a month, and halfway through her stay she wrote an email for her friends describing her battle against rejection in graphic detail (see below).
Jackson cannot speak too highly of her treatment at Papworth: the place saved her life. And she cannot speak too highly of TransMedics, the company that manufactures the machine that kept her donor heart warm and beating, suffused with oxygenated blood, as it moved from the donor to her own chest, a new procedure that improves on the traditional method of packing the organ between ice or cold saline, and maintains the quality of the heart for longer. (Papworth hosted the first such operation in the UK in June 2006; Karen Jackson's was the second.)
Jackson plans to take part in the Transplant Games this August in Sheffield. But only 40 years ago, the prospect of substituting one human heart with another was judged to be perilous and sinister, and its proponents were widely considered to be insane. When the first heart transplant in the UK took place at the National Heart Hospital in London in May 1968 (this was the tenth heart transplant in the world; the first was performed by Christiaan Barnard in South Africa in December 1967), it was such a difficult task, and such an ethically controversial procedure, that efforts were made to conceal the operation from the media. But this was the 10th heart transplant in the world, and it made headline news for several days. The initial euphoria was followed by disillusion. The transplant itself was not hugely complex (one of the surgeons in the operation called it 'quite a simple plumbing job'), but the challenges of rejection and infection were insurmountable.
When the pioneers from that era met at the Wellcome Institute for the History of Medicine in London a few years ago, they spoke of a world we may now consider comical. Professor Donald Longmore, a consultant surgeon at the National Heart Hospital, recalled performing a great number of experimental transplants on dogs, sheep and pigs, but they weren't always obliging patients. On one occasion in the late-Sixties, two pigs were delivered into the mews at the back of the hospital, to the alarm of the head porter. 'Is that pig in a Land Rover anything to do to with you?' he asked Longmore.
'Yes it is,' the surgeon said.
'Well it has just got out and turned left along New Cavendish Street.'
Longmore, still in his theatre mask and boots, pursued the pig through the streets. He finally caught up with it in Wimpole Street, grabbing it by its tail. A man in a bowler hat commented on the sight, objecting that the pig was going the wrong way up a one-way street.
Longmore persevered. His first human recipient, a man called Fred West, was a devout Catholic, and Longmore enlisted church leaders to support his attempts to offer him a new life. His donor, a building worker named Patrick Ryan, was also a Catholic, 20 years younger than West, and he shared the same blood group. He had been killed in an accident with concrete slabs at work, and as his body was being driven to the hospital for harvesting, the news was leaked to the press by a member of the medical team. The operation was performed by Sir Keith Ross and Donald Ross, and not long after they appeared at a press conference at which they explained the details of the transplant to the press, they had to fend off rumours that the donor had been 'murdered' for his heart - that he was not yet fully dead at the time he was cut open.
The patient died after 46 days. His post-operative history is one of many episodes of rejection treated with a wildly experimental cocktail of drugs. This was the key problem with all early transplants: how was it possible to balance the suppression of the immune system necessary to make a patient accept a foreign organ while also making that recipient resistant to infection? Then, as now, hospitals were storehouses of potentially fatal bacteria. It would be a decade before this problem was partially solved with the introduction of the immunosuppressive drug cyclosporin, the single most important advance in the history of transplants. But until then - between 1968 and the late Seventies - an international moratorium was declared. Not enough was known about how to keep transplant patients alive, and great expectations were frequently followed by rejection and failure. Surgeons went back to rehearsing on animals.
Steven Tsui was still at school when he saw a television report about the first successful heart transplant at Papworth in 1979. 'I was mesmerised,' he recalls of Sir Terence English's operation. 'I thought, "This is what I want to do." So I tried to find out how one becomes a heart transplant surgeon, but of course in 1979 it wasn't anything, it wasn't a chosen career path.'
Tsui went to medical school in Cambridge, trained as a surgeon under Sir Terence English at Papworth in the Eighties, and worked his way up. A few months ago, as director of transplant services at Papworth, he alerted the world to the fact that his department was in trouble.
His office in the hospital is a plain affair, not at all suggestive of the glamour that once attended his speciality. Among his papers is a recent copy of Transplant Times, and on page three is a photo of his smiling face and a quote beneath it: 'Patient safety is of paramount importance to us. We believe the process we have gone through in this review [into the recent deaths] has been rigorous and proper and will help us to continue to provide the best possible outcomes for our patients.' To read his comments, and its stock phrasing, the reader could almost believe that nothing significant had happened.
In the time that elapsed between Tsui's schooldays and his current senior position, his chosen field has matured into an established medical discipline, although its expansion has slowed significantly in recent years. According to records maintained by UK Transplant, 5,364 heart transplants have been carried out in seven hospitals in the past 30 years, as well as 1,102 heart transplants combined with other organs, predominantly lungs. More than 1,100 of these have been performed at Papworth (the other transplant centres are Harefield Hospital, near Uxbridge; Queen Elizabeth Hospital, Birmingham; Freeman Hospital, Newcastle; Wythenshawe Hospital, Manchester; Glasgow Royal Infirmary; and Great Ormond Street, London).
In the last year for which complete figures are available (April 2006-March 2007) a total of 162 hearts were transplanted in the UK - 155 heart-only transplants, six combined heart-and-lung transplants and one combined heart-and-kidney transplant. This is less than half the activity recorded in 1990, when 351 heart transplants were performed (the current figure for the year from April 2007 to mid-March 2008 is lower still, at 121). On average, about 80 per cent of patients are still alive a year after the operation, and 69 per cent are alive after five years. UK Transplant claims 'both these figures are improving all the time', which makes the recent spate of deaths at Papworth all the more unusual.
Unlike the days when squealing pigs were chased down New Cavendish Street, the field of transplant surgery - not just hearts, but also lungs, kidneys, livers, the pancreas and, most frequent of all, corneas - is now regulated by a strict protocol and hierarchy, and there is a firm recognition of best practice.
When the Healthcare Commission delivered, on 19 November, its findings into the eight deaths at Papworth, it made 12 recommendations. It noted the general quality of care at the transplant unit was good, but that there was room for improvement. The recommendations included: minimising the time the heart is left without blood supply during transportation; a careful review of the use of the solution which temporarily paralyses the organ's tissue during the transplant; changing the current arrangements in which the surgeon undertaking the transplant operation is also responsible for post-operative care; an immediate investigation into any new deaths, initially involving external review; and finally, a suggestion that all future patients contemplating heart transplants are properly informed about Papworth's recent increase in mortality rates and the subsequent attempts to improve them. If all these recommendations were adopted, the Healthcare Commission agreed transplants at Papworth could resume. But they had no specific explanation as to why so many recent operations ended in failure.
'We felt we didn't have anything to hide,' Steven Tsui tells me. 'People think we have been very open and honest and responsible in our approach.' Tsui speaks of the UK's critical shortage of organs, and of the decline in the health of the hearts he is able to use. Between March 2006 and April 2007, 28 people died in the UK while listed for a heart transplant because a suitable donor could not be found in time; three years earlier, the figure was 10 people.
But the issue of waiting lists can be deceptive, for it is the transplant hospital itself that decides how long the list should be. As Tsui says, 'Conventionally we would say if people's life expectancy was a year or less we would consider them a candidate for a heart transplant. But we also have to manage expectations. If we know that in an average year we will do 30 heart transplants, there is no point putting 60 people on our waiting list, because we know half of them will die and it's not right to give them false hope.' In other words, there may be thousands of patients who would materially benefit from a transplant if only the resources and organs were available.
There are several reasons for the fall in usable hearts with which Tsui's team can work, but by far the greatest is the way we look after each other on the roads. The laws governing seatbelts, motorcycle helmets and speed, coupled with the tighter punishments for drink-driving and safer cars, have ensured that fewer young people kill themselves in accidents. Health and safety regulations have resulted in fewer fatal accidents at work. And improvements in drugs in recent years for those who have suffered a brain haemorrhage or a stroke have also had a direct result on donor hearts. The drugs stimulate the brain to correct itself, but in the process thrashes the heart and lungs to deliver the extra blood pressure it needs. By the time a donor is normally declared brain dead, the heart has often been ruined too.
When Papworth began its transplant programme, the average age of donors was about 27; but this has gone up gradually for the past 15 years, to the point where it is now 41; the outcome of transplantations has always been related to the age, health and strength of the donor heart.
There are other problems, not least the rules governing the distribution of hearts within the UK. In the early days of transplants, Papworth would get the majority of the hearts available. When rival claims came from Harefield and then other hospitals, each transplant centre was allocated a favoured day: Harefield might get any heart that became available on a Tuesday, for instance, and Newcastle on a Wednesday. Because hearts only remain usable on ice for a few hours, this system was replaced by one that established a travel radius between hospitals. Papworth would be notified of any donor heart that became available in the east of England, and its waiting list was checked for a suitable match of size, blood group and other factors. If none was found, the heart would be offered to other centres in turn.
But in 2001 a new system was introduced that distributed donor hearts according to urgency. Each hospital could call on the next available heart according to the critical condition of its patients, irrespective of geographical location. This seemed logical, but it was worryingly vague: would one consultant's definition of 'urgent' match another's? The system has threatened to set one hospital against another. 'Our use of the urgent card has not changed,' Tsui tells me, 'but our impression is that other centres have more regularly used the urgent card.'
Playing the urgent card does not, of course, ensure the patient receives the best heart; the opposite may be true, not least if a heart has been flown from one end of the country to the other (this may be another reason for an increased failure rate). Tsui believes there is an easy way to reduce the mortality rate at his hospital - by turning down high-risk operations. 'But that is doing a disservice to those patients. If they have a 10 or 15 per cent risk of failure, they'll still be better off, because without it they're doomed. So there is a danger that the monitoring process may deny patients treatment that they would benefit from.'
It looks as though this may have been precisely what has been happening. Between mid-November 2007 and mid-March2008, the period following the resumption of transplants at Papworth, there have been four heart transplants and one combined heart/lung transplant; in an average four-month period in previous years there would have been about 10.
The dilemmas at the hospital do have a history. In 2002, Stephen Large, a transplant surgeon at Papworth, wrote a letter to the Lancet suggesting there might be a 'crisis' in his industry. Donor availability was only one problem, he argued, observing that there was also significant disorganisation and 'organ wastage'. He saw considerable disillusionment among the young trainees he worked with. He noted that, 'Without skilful human-resource management further decline is inevitable, and the future remains bleak for heart transplantation and probably for transplantation in general in this country.'
We may reasonably question how much things have improved over the past five years, and the conclusion is not encouraging: fewer patients with heart failure are receiving new hearts; of those who are, their new organs are, on average, less healthy than they were a few years ago. And then there are deeper issues, suggesting that Papworth, and perhaps other UK centres, may have lost its pre-eminent position in the transplant world.
One former member of the transplant unit at Papworth, who spoke on the condition of anonymity, claimed that the department 'had turned into a sausage factory' before the recent deaths. 'The system is not meritocracy based,' he told me. 'It's who's watching whose back. In addition there are limited budgets, so all sorts of factors are putting pressure on them. The transplant community is so small in England, and under such pressure, that I'm concerned that the [Healthcare Commission] report had to sanitise things a little bit for public consumption. Even if they knew the truth, I'm not sure they would have put it out there in an unadulterated form, for the good of the nation and for the good of transplantation.'
He believes that Papworth is 'doing a lot of dodging', waiting now for surefire successes. 'But I think it's not unique to Papworth. Once, England was one of the leading places for cardiac transplants, but it's clearly become second rate,' he says, suggesting that we are falling behind centres in Germany and the US.
Steven Tsui disputes these claims, and says he still has the full confidence of his staff and, perhaps more significantly, his patients. He says that when news of the poor results became known, no one asked to be transferred to another unit. 'All the patients we wrote to before the operations were suspended said, "We trust you - we don't want to move."'
One of these patients is Karl Endacott, a 39-year-old from southeast London who has been on Papworth's waiting list since January 2007. Endacott has muscular dystrophy, and he learnt at the age of 14 he might one day require a new heart. His symptoms are familiar - shortness of breath, extreme tiredness after climbing stairs - but they have been complicated by kidney failure. His heart struggles to pump a sufficient supply of oxygenated blood throughout his body, and a few weeks ago he was fitted with a Ventricular Assist Device to aid pumping and increase the circulation.
Endacott received a phone call from Papworth the day before the hospital announced it had been asked to suspend operations, and the news came as a surprise. 'It has such a high reputation,' he says. 'But I think what they did was the right thing.' He is pleased to be back in the queue again, and his heart still manages to leap when the phone rings at night. 'In the day it's not so bad,' he says, noting the majority of transplants take place in the early hours. 'It's usually when the phone goes in the evening that I think, "Could this be it?"'
'Not pain, but agony': Karen Jackson on her first fortnight with a new heart
'Whilst on the transplant list, the co-ordinators prepare you quite brutally for what lies ahead, but even that could not have softened the blow of what I have been through. I think I truly understand mental and physical AGONY. The operation was a great success - the surgeons were all patting themselves on the back. The next stages were a blur. I have very little recollection of the intensive care unit, but hated being on the ventilator and was so relieved to get that out. I was on lots of drips and drains but the morphine was great, I was in cloud-cuckoo-land. I was so excited about how great I felt - the only pain was in the sternum wound and it was awkward not being able to move too much. Each day saw some changes: stitches out, drains and catheter out, more mobility - I felt progress was very quick. I was weaned off the morphine and had a major downer - crying time approximately six hours - uncontrollable, laughing and crying simultaneously.
'I started to be loaded up with huge doses of immunosuppressives, steroids, anti-fungals, antibiotics, statins, etc, etc. And that was when the 'fun' really began. I had horrific diarrhoea - a gut spasm is no fun with a chest wound. This took about four days to pass. In the interim I had a reaction to another drug: I had a convulsion/fit in my head which continued to occur every time I moved. I have never known such extreme pain. Not pain, agony. So I reach the absolute pit of misery and shamefully admit I wanted to be allowed to die. I have felt for the past 10 days like I've been beaten over the head continuously and the docs are still juggling medicines.
'But things look different again this morning. I had a decent night's sleep and woke feeling much brighter. I just have to stay upbeat and put my faith in the doctors...'
