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The Healthcare Commission today said that Papworth Hospital NHS Foundation Trust could resume heart transplant operations following the trust’s agreement to implement additional safeguards to protect patients.

After a two-week review, the independent watchdog said quality of care was good and there were no common factors to explain the recent rise in the number of deaths.

But it promised to scrutinise closely the performance of the unit and act quickly if there was any future cause for concern.

Heart transplants at the trust were paused while the Commission undertook the review at the request of the Chief Medical Officer (CMO).

The trust itself had raised concerns with the CMO, following the death of seven out of 20 heart transplant patients from January to September this year. An eighth patient died following a heart transplant in October.

Between January 2004 and December 2006, the national mortality rate within
30 days of undergoing a heart transplant was 10%. The mortality rate at
Papworth for the same period was 7%.

The Commission’s review team, including top heart surgeons, reviewed individual case notes, interviewed members of staff and carried out statistical analyses.

The Commission noted that the time the transplanted heart was without blood supply was longer for those patients who died. However, these times on average were lower than in previous years at the trust and generally in line with the national average.

The process to assess whether patients are good candidates for a heart transplant was considered to be extremely rigorous. In all cases reviewed, taking into account the combination of risk factors, the decision to transplant was thought appropriate.

The Commission said the trust acted responsibly in responding to the rise in the number of deaths, including seeking external expertise and cooperating with the Commission’s review. The trust conducted its own review of heart transplants earlier this year and implemented a number of changes to its procedures.

The Commission has made 10 recommendations to the trust to ensure that known risks associated with heart transplantation are minimised.

The trust has accepted the recommendations and told the Commission that it
will put them in place with immediate effect.

The recommendations include:
. ensuring that hearts were stored in transit in a manner that was in line with other UK trusts;
. reviewing its use of cardioplegic solution, which cools the heart during surgery, in terms of the relatively high volume administered, the pressure and the relatively high concentration of potassium, to ensure it is in line with current practice in the UK;
. setting out more clearly the agreed arrangements for keeping the heart cold during surgery;
. reviewing arrangements for post-operative care to ensure that workload is shared better across different members of the team;
. reviewing future deaths without delay to identify whether immediate improvements are called for, involving independent experts in the process;
. informing patients of the recent rise in mortality before they undergo a heart transplant at the trust.

It also made two recommendations to national organisations.

. The National Commissioning Group and UK Transplant should consider the feasibility of introducing a national standard on information about retrieved organs provided to trusts receiving donor organs.
. The Department of Health should seek advice from UK Transplant and the Royal College of Surgeons to agree a threshold for rates of mortality following heart transplants at Papworth. If the number of deaths exceeds this, an urgent review should be triggered with immediate action where necessary.

Nigel Ellis, Head of Investigations at the Healthcare Commission, said:

“Heart transplantation is extremely high-risk surgery carried out on very ill patients. In so many ways, the Papworth Hospital Transplantation Service represents best practice and its good reputation is well deserved. Many of its patients may not be alive today without a transplant.

“I want to be clear that we did not find any evidence of inadequate care or evidence that the deaths could have been prevented. But the number of deaths since January has clearly been high.

“This is why we are asking the trust to put in place a number of important checks and safeguards. With these in place, the public can be reassured that everything possible is being done to protect heart transplant patients.

“We and the trust will keep performance under particularly close scrutiny over the coming months. And we will respond very quickly if there is any future reason for concern.

“I would like to praise the trust for triggering this process. That in itself suggests an organisation that is putting patients first and should give the public confidence.”

Chief Medical Officer, Sir Liam Donaldson, said:

"I welcome the Healthcare Commission's report and am grateful for the speed with which they have undertaken this review. The Commission has made a number of recommendations to improve some aspects of practice in line with the best standards. Papworth Hospitals NHS Foundation Trust has accepted these recommendations, and has already commenced work to ensure that they are put into practice.

“Heart transplantation operations are inherently high risk and we need to continuously monitor services to assure quality and the safety of patients. The transparency and openness demonstrated by the trust in this instance is commendable."

Notes to editors

· The Healthcare Commission’s review team was assisted by two
consultant cardiac surgeons to provide clinical expertise: Professor John
Dark and Professor Robert Bonser.

· Please refer to the following pages of the report for explanations of
the recommendations: recommendation 1 (pg 9); recommendation 2 (pg 10);
recommendation 3 (pg 10); recommendation 4 (pg 12); recommendation 5 (pg
12); recommendation 6 (pg 12); recommendation 7 (pg 13); recommendation 8
(pg 13); recommendation 9 (pg 15); recommendation 10 (pg 17);
recommendation 11 (pg 17); recommendation 12 (pg 18).

· Part of NHS Blood and Transplant, the key role of UK Transplant is to
ensure that organs donated for transplant are matched and allocated to
patients in a fair and unbiased way.

· The National Commissioning Group is a standing committee of the
National Specialised Services Commissioning Group, which oversees the
national commissioning of highly specialised services and facilities.

· In the recent annual health check performance ratings conducted by
the Healthcare Commission, Papworth Hospital NHS Foundation Trust was rated
“excellent” for both quality of services and use of resources.


Information on the Healthcare Commission

The Healthcare Commission is the health watchdog in England. It keeps check on health services to ensure that they are meeting standards in a range of areas. The Commission also promotes improvements in the quality of healthcare and public health in England through independent, authoritative, patient-centred assessments of those who provide services.

Responsibility for inspection and investigation of NHS bodies and the independent sector in Wales rests with Healthcare Inspectorate Wales (HIW). The Healthcare Commission has certain statutory functions in Wales which include producing an annual report on the state of healthcare in England and Wales, national improvement reviews in England and Wales, and working with HIW to ensure that relevant cross-border issues are managed effectively.

The Healthcare Commission does not cover Scotland as it has its own body, NHS Quality Improvement Scotland. The Regulation and Quality Improvement Authority (RQIA) undertakes regular reviews of the quality of services in Northern Ireland.

For further information contact the press office on 0207 448 9210 or on 07779 990845 after hours.