Scientific, ethical, and logistical considerations in introducing a new operation: a retrospective cohort study from paediatric cardiac surgery
Research in this week's BMJ says that deaths soon after a new operation in new born babies can exceed deaths expected after a more established procedure, particularly when the new operation is first introduced. This need not mean that either the surgery or the surgical team are unsound, concludes the research, but that safeguards should be in place to minimise the risk to patients.
Researchers say that doctors and relatives need to accept both the risk implications of the change over period and that operations can differ in their profiles of early and late hazard.
Bull and colleagues from Great Ormond Street Hospital, London, reviewed the initial impact on death rates of a new surgical technique for congenital heart disease that is now taken for granted. They reviewed the outcome of 325 babies with transposition of the great arteries before during and after their treatment was changed from the Senning operation to the Arterial Switch surgery between 1978 and 1998. The "new" operation involved more difficult surgery on younger babies of less than three weeks old, with greater short term risks, but anticipated greater long term benefits.
The results showed that early deaths were lower in 1998 with the Switch operation than in 1978 with the Senning procedure. However, while arterial Switch was gradually being adopted between 1986 and 1992, death rates were higher among those patients scheduled for Switch than among those scheduled for the Senning operation. But follow up has shown that premature deaths later in life have been more common after the older Senning procedure as had been predicted at the time the new operation was first offered.
The authors say that in children's surgery in particular, doctors often have to make recommendations that aim to improve life expectancy when there is only scant evidence about later risks of treatment. This means that every effort must be made to minimise the early risk to patients and to explain the aims of treatment and the hazards and uncertainties involved to the relatives.
Dr Catherine Bull, Cardiothoracic Unit, Great Ormond Street Hospital, London Email: C.Bull@gosh-tr.nthames.nhs.uk