The dangerous machine here? The man

After the case of a robotic operation that went horribly wrong, here’s what you need to know before going under the robo-knife – and it starts with researching the surgeon at the controls

FIRST, you are strapped from the chest upwards on to the table, with your feet hoisted into stirrups. The table is swung down backwards, so you are tilted, head-down, at an angle of 45 degrees. Then a machine, known by some surgeons as ‘the 800lb gorilla’, can get to work. It sounds so medieval, but this is the most modern of surgical techniques — robotic surgery. The extraordinary posture, known as the steep Trendelenburg, is necessary to position the patient precisely so the robot arms can reach inside them. But this ‘precarious positioning’, as it has been described in the British Journal of Anaesthesia, demands significant care to protect patients. Left in this position, often for up to four hours, they can develop complications including injuries to their cornea and nerve damage in their hands and feet, as well as dangerous buildups of fluid in the brain and lungs and blood clots that can cause strokes, warned a study published last year by Imperial College London and the Royal Marsden hospital. To all this complexity, add the convolutions required for a surgeon to command his team through a highly challenging operation, ‘with his head immersed in a console’.

‘The rest of the medical staff is scattered, usually unable to see each other’s faces . . . for long stretches,’ warned researchers at Cornell University in the U.S. at a conference earlier this month.

This hampers effective teamwork, say the investigators, who spent two years watching robotic surgeries. ‘They definitely have to do more to overcome the challenges brought by the robot.’

Robotic surgery sounds like the ultimate in flawless, high-tech, 21stcentury care — a whirring world of foolproof shiny machines performing intricate medical procedures with perfect precision.

But, in reality, it can be convoluted and time-consuming. And, make no mistake, controlling these machines requires enormous skill and training.

FLAILING ROBOT CAUSED PROBLEMS

The machines might be called ‘robots’, but they are entirely under the control of a potentially fallible human surgeon. And things can go horribly wrong.

This was tragically seen in the shocking case heard last week at an inquest into robotic heart surgery at the Freeman hospital in Newcastle in February 2015.

The revelations about the death of father of three Stephen Pettitt, 69, following a disastrous operation performed by surgeon Karunakaran Sukumaran Nair, must surely call into question the use of surgical robots in the NhS.

The £1.7 million, U.S.-built machines, called Da Vinci robots, are already beset by controversy over whether they offer any real advantage over traditional human surgeons.

Now, evidence presented to the coroner has exposed the perilous way in which medics may use these vastly complex gadgets without exhaustive technical training and supervision.

Stephen, a retired music teacher, died of multiple organ failure after the failed procedure to repair a damaged heart valve. Stephen was slim and otherwise in sufficiently robust health to be considered a good candidate for the untested robotic technique, the first heart valve surgery in the UK to involve the Da Vinci robot.

But the procedure descended into a bloody morass of mistakes. Conditions in the operating theatre were tense and chaotic.

Mr Nair’s assisting surgeon, Thasee Pillay, told the coroner that, at one point, a nurse’s arms were knocked by the flailing robot.

The robot surgeon was ultimately abandoned after its viewing camera was blinded by blood from Stephen’s failing heart. Theatre staff tried to save him by performing conventional open-heart surgery. But it was too late, and he died a few days later.

Robotic surgery has been used increasingly in prostate cancer surgery since the early 2000s, but Stephen was not told the technique had never been tried on mitral heart valves before in the UK, which placed him at an increased risk of death.

Nor did the surgeon inform him that he was not properly trained.

For, as Mr Nair admitted at the inquest, when he undertook the operation, he’d not had one-to-one training on the use of the Da Vinci robot. he had only observed others and practised on it alone.

SURGEONS NEED PROPER TRAINING

he’D also missed a training session in Paris and another at his hospital because he was busy operating. he was said to have told a colleague that he ‘could have done with some more dry-run training’.

At the inquest, assisting surgeon Mr Pillay complained that communication with Mr Nair was disturbed by the sound from the robot and he had to shout when he realised that sutures were not being placed in ‘an organised fashion’ into the patient’s heart.

Mr Nair agreed with coroner Karen Dilks that it was ‘more likely than not’ that Stephen would have survived had conventional open-heart surgery been used. he no longer carries out robotic surgery.

The question is whether enough is being done to protect other patients.

Professor Naeem Soomro, director of robotic surgery at Newcastle upon Tyne hospitals NhS Trust, which runs the Freeman hospital, said: ‘With Da Vinci surgery, the surgeon must undertake a series of dry lab and simulation courses before they can start operating, only under the supervision of a mentor.’

On its website, the trust hails itself as offering ‘the most comprehensive’ robotic surgery programme in the UK, conducting robotic surgery in six specialities. Professor Soomro said: ‘There has been a paradigm shift in our attitude; it has gone from “Why should it be done by robot?” to “Why shouldn’t it?” ’

But such enthusiasm carries the risk of running far ahead of surgeons’ competence and of evidence to prove that robot surgery is either useful or safe in complex operations.

Shockingly, there are no legal requirements as to how surgeons should be trained to operate the machines or who should trial new operations and how.

In 2014, the european Commission’s RoboLaw project concluded surgeons must meet professional requirements for training in robotic surgery. But it was never stipulated how much training surgeons must receive.

Some studies have suggested that a surgeon must be involved in 100 robo-ops before they can be deemed proficient. But currently, training is being introduced across differing specialities piecemeal.

Greg Shaw, a consultant urological surgeon at University College London hospitals NhS Trust, and director of the trust’s robotic urology training fellowship programme, says that he can’t understand how Mr Nair’s case came about. ‘I do a lot of robotic surgery — the robot is a specialised tool requiring training and I can’t imagine anyone working alone on the robot without them proving they know what they are doing,’ he says.

Mr Shaw adds that his specialism, urology, is the most advanced in terms of training and education in robotic surgery. ‘There is a defined process of robotic training in urology, with formal training programmes in place, a process where, until surgeons are deemed competent, they are

allowed only to work with the robot under supervision.’

Even when surgeons are allowed to do the whole robotic operation, they ‘are supervised by mentors in the early stages of their independent practice’.

But not all specialisms are so advanced, he suggests. ‘The relevant authorities for other specialisms are in the process of drawing up training programmes.’

And herein lies a peril for developing new robotic procedures in the NHS, especially first-ever ops such as Stephen’s heart surgery. They involve heading into the unknown. The expected approach is to ensure anything new is ‘performed by teams of experts working in concert, with a series of small adaptations, rather than one major change, and on patients who understand what is being proposed,’ says Mr Shaw. Instead, numerous surgeons eager to operate Da Vinci robots are flying by the seat of their pants.

In January, analysts at GlobalData Healthcare warned that increasing numbers of surgeons are teaching themselves, often just by watching others do it.

Another concern is that the machine can go awry. A 2016 study in the journal PLOS One said that faults during robotic surgery include burnt and broken pieces of instruments falling into patients, electrical short circuits burning Daily Mail, November 9

flesh and the robot’s computer and camera breaking down.

In more than a thousand cases, the whole system had to be switched off and restarted, or surgeons had to revert to conventional surgery or abandon the operation entirely.

Then there is the fundamental question as to whether expensive and complex robots are any better than human hands.

Consider the operation Stephen Pettitt was offered — mitral heart valve repair. In April, a study in The Journal of Thoracic Cardiovascular Surgery, which compared the outcomes of 142 patients who had robotic surgery with outcomes from conventional surgery, found that ‘more patients in the robotic group had serious complications’.

A similar picture emerged across all specialisms in a report in PLOS One in January: ‘Despite its higher costs, robot surgery does not result in statistically better outcomes... conventional surgery has significantly more favourable operation lengths and complication rates.’

Last week, coroner Karen Dilks warned that there ‘remains a risk of further deaths’ from robotic operations and said she would contact the Royal College of Surgeons and the Department of Health to ask them to consider whether national guidelines on training and practice should be brought in.

Meanwhile, the Royal College of Surgeons told Good Health: ‘It would be wholly unacceptable for any surgeon to perform an operation they have not fully trained for.

‘All NHS trusts have guidelines for performing innovative surgical techniques, as well as using new technologies, which trained surgeons are expected to follow as they expand their area of practice.’

Dr Andy Welch, medical director of Newcastle upon Tyne Hospitals NHS Trust, says that following Stephen’s death, ‘the robotic heart programme was stopped and significant changes have been made’.

But Mr Shaw has this advice for anyone offered a robo-op: do your own research into the competence of the surgical staff before agreeing to it. ‘If people believe that the robot does the operation, then they are mistaken,’ he says.

‘These machines are not autonomous robots. The machines only perform the action that the surgeon instructs them to.’

Robot op patient had 99% survival chance with regular surgery

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