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England's health services watchdog, the Healthcare Commission, has said that surgeons can resume heart transplant surgery at Papworth Hospital near Cambridge.
Earlier this month the commission had suspended operations pending an investigation into the higher than expected mortality among 20 people who received heart transplants at the hospital this year (BMJ 2007;335:955, 10 Nov doi: 10.1136/bmj.39391.719329.4E).
The commission's two week review, which looked at the clinical care provided to eight patients who died and the trust's response to the deaths, concluded that there were no common factors to explain the deaths, which could not have been prevented. And there was no evidence that care had been inadequate, it said.
The selection of patients deemed suitable for surgery was “extremely rigorous,” and the decision to transplant had been appropriate in all cases, said the commission.
The trust had also acted responsibly by promptly alerting the chief medical officer to the higher than expected death rate and by seeking external expertise, it said.
The commission found that the periods that transplanted hearts were without a blood supply (ischaemic time) were longer in those patients who died than in other patients; but these were, on average, lower than in previous years at the trust and in line with the national average.
It says too that some patients had a combination of factors that increased their risk of transplant failure—such as being older, a long ischaemic time, and a mismatch in size. But none of the cases reviewed was at such a high risk that the transplantation should not have gone ahead, the report says.
The commission has recommended that the trust take all possible steps to minimise the time that any organ is without a blood supply, particularly in cases where more than one organ is being retrieved from the same donor.
It recommends that consideration also be given to the feasibility of introducing a national standard on information that trusts should be given about retrieved organs.
The Department of Health should also set a mortality threshold for the trust, breaches of which should prompt a wider review of procedures, it said.
Nigel Ellis, head of investigations at the commission, said that the safeguards and checks the commission had requested of the trust would ensure that “everything possible is being done to protect heart transplant patients,” and he added that the watchdog would keep a close eye on death rates at the trust over the next few months.
The trust has fully accepted all the review's recommendations.
Steven Tsui, clinical director for transplant services at the trust, said, “We believe the process we have gone through in this review has been rigorous and proper and will help to continue to provide the best possible outcomes for our patients.”
Intervention at Papworth Hospital NHS Foundation Trust is at www.healthcarecommission.org.uk.