BMJ 2018;363:k4791 doi: 10.1136/bmj.k4791 (Published 12 November 2018) Page 1 of 1 News Robot assisted surgery is blamed for heart patient’s death Clare Dyer The BMJ A coroner overseeing an inquest into the death of a 69 year old man after a pioneering robotic heart operation went wrong has concluded that a risk of further deaths will remain unless additional safeguards are introduced. The coroner, Karen Dilks, said that the death of retired music teacher Stephen Pettitt came as a “direct consequence of the operation and its complications.” She added, “Mr Pettitt died due to complications of an operation to treat mitral valve disease and, in part, because the operation was undertaken with robotic assistance.” The inquest heard that the operation in February 2015 at the Freeman Hospital in Newcastle was the first of its kind in the UK. The surgeon, Sukumaran Nair, had observed other surgeons using the Da Vinci robot and practised alone on a simulator but had not had any one to one personal training in its use. Nair admitted that he had not told Pettitt that he ran a higher risk as the first patient to undergo robotic mitral valve surgery than if he had had conventional open heart surgery, which carried only a 1-2% risk of death in his case. An expert report concluded that Nair’s cross clamp times in conventional operations were slow and that moving to robotic procedures was “a premature step, running before you could walk.” Two “proctors” (expert doctors) who were experienced in robotic surgery, supplied by Edwards Lifesciences, had left the hospital part way through the operation. However, they could not have intervened in any event because they were not registered with the General Medical Council, the inquest was told. Thasee Pillay, the surgeon assisting in the operation, told the inquest that he and Nair struggled to concentrate and to talk to each other because of a “tinny” noise from the robot. He had to raise his voice when he realised that the stitches were not being For personal use only: See rights and reprints http://www.bmj.com/permissions placed in an “organised fashion” after the robot knocked a theatre assistant’s arm. Near the end of the operation, when it was discovered that the sutures needed to be repaired, the aorta had been cross clamped for a considerable time and the patient developed a bleed that blinded the robot camera. The surgeons decided to move to open heart surgery, but Pettitt’s heart tissue had deteriorated too much, and he died from multiple organ failure in the next days. Edwards Lifesciences pointed that it was not the manufacturer or the supplier of the Da Vinci robot, so was not involved in the training or proctoring of this device. It was not called to the inquest and did not comment on the operation. In a statement to The BMJ it said, “The Edwards Lifesciences proctors attended in relation to two other devices, manufactured by our company, which were used early in the procedure. These devices were both implanted and functioning appropriately when the proctors left with the agreement of the surgeon. A company clinical specialist remained in the operating theatre throughout the procedure and, to our knowledge, these products functioned as intended.” Dilks noted that there was “an absence of any benchmark” at Newcastle Hospitals NHS Foundation Trust for training in new intervention treatments. Nair had been offered training in robotics by the gynaecology department but had not taken it up. The coroner also said that the trust should develop a policy covering the use of proctors and should ensure that consent forms detailed the risks of new procedures. She said that she would ask the Royal College of Surgeons and the Department of Health and Social Care to consider whether national guidelines should be introduced in England. Nair now works in Scotland and no longer does robotic surgery. Subscribe: http://www.bmj.com/subscribe BMJ: first published as 10.1136/bmj.k4791 on 12 November 2018. Downloaded from http://www.bmj.com/ on 30 November 2023 by guest. Protected by copyright. NEWS