**2. Heart and lung transplantation**

This section includes elements reproduced in full, or paraphrased, with permission from *The Royal College of Surgeons of England Clinical Effectiveness Unit and NHS Blood and Transplant UK Cardiothoracic Audit End of Year Report from the Audit Steering Group to the National Commissioning Group (Rogers et al., 2010)*. (These have been reproduced to ensure technical consistency and accuracy in relation to how transplant related data are collected, analysed and presented.

Heart and lung transplantation has been nationally commissioned in England since 2002. Currently cardiothoracic transplantation is provided by the following hospital Trusts:


Systems for monitoring early and late mortality for heart and lung transplants are linked to data routinely collected by NHS Blood and Transplant (NHSBT), a Special Health Authority within the NHS with responsibility for "*optimising the supply of blood, organs, and tissues and raising the quality, effectiveness and efficiency of blood and transplant services*". (NHS Blood and Transplant, 2011). Data have been recorded on all patients in the UK receiving a first heart, lung or heart and lung transplant since 01 July 1995. Reports using these data have been published annually for all patients receiving a cardiothoracic transplant from 01 July 1995 to present day.

Patient level information is submitted to NHSBT at key steps along the transplant pathway: (i) when the patient is registered on the national transplant waiting list; (ii) at the time of the transplantation; (iii) three months after having the transplant; (iv) and annually thereafter until death. These data are transferred on a monthly basis to the UK Cardiothoracic Transplant Audit team based at the Clinical Effectiveness Unit (CEU) of the Royal College of Surgeons of England (RCS). The data submitted are subjected to on-going process of validation including the use of computer-based validation and case notes reviews, and as a result are robust and reliable.

The database held by NHSBT / Royal College of Surgeons Clinical Effectiveness Unit forms the basis of the UK Cardiothoracic Transplant Audit. The UK Cardiothoracic Transplant Audit is a multi-centre prospective cohort study. The audit has donor, recipient and outcome data on all cardiothoracic transplants undertaken in the UK since July 1995 and allows for prospective and retrospective audit of the outcomes from cardiothoracic transplantation. Because the data are collected in a timely manner as outlined above the data collected also allows real-time monitoring of outcomes for each transplant centre that can be used for monitoring performance.

The audit is undertaken by a project team, overseen by a steering group, comprising the directors of all cardiopulmonary transplant centres in the UK, the director of the Royal College of Surgeons Clinical Effectiveness Unit, and representatives from NHSBT and the National Specialised Commissioning Team. The Steering Group approves all output from the audit prior to publication.

The UK Cardiothoracic Transplant Audit publishes on an annual basis the 30-day, 90-day, 1 year, 3-year, 5-year and 10-year mortality after first intrathoracic transplantation at all cardiopulmonary transplant centres in the United Kingdom. Centre-specific 30-day and 90 day mortality is reported for the more recent cohorts with 1-year and 3-year mortality being presented for the most appropriate recent cohort as well as for the period as a whole. Five and 10-year mortality rates are reported for the entire period as a whole. The Audits are available on the Royal College of Surgeons of England website (www.rcseng.ac.uk/surgical\_research\_units/ceu/docs.html) (see Rogers et al., 2010).

Results for adult (age ≥ 16 years at transplant) heart and lung transplants and paediatric heart and lung transplants are reported separately. The results for 30-day, 90-day and 1-year mortality after adult heart transplantation and 30-day and 90-day mortality after adult lung transplantation are presented both with and without adjustment for case-mix. The risk models used for case-mix adjustment have all been developed specifically for this audit.

The risk-adjusted estimates of early mortality after adult heart transplant for the most recent cohort of patients available (April 2007 – March 2010 [December 2009 for 90-day mortality]) are shown as funnel plots in Figures 1 and 2.

Figures 1 and 2 highlight that both the 30-day and 90-day mortality for each centre in the UK is within the range expected with no centre experiencing a mortality that was lower or higher than expected.

within the NHS with responsibility for "*optimising the supply of blood, organs, and tissues and raising the quality, effectiveness and efficiency of blood and transplant services*". (NHS Blood and Transplant, 2011). Data have been recorded on all patients in the UK receiving a first heart, lung or heart and lung transplant since 01 July 1995. Reports using these data have been published annually for all patients receiving a cardiothoracic transplant from 01 July 1995 to

Patient level information is submitted to NHSBT at key steps along the transplant pathway: (i) when the patient is registered on the national transplant waiting list; (ii) at the time of the transplantation; (iii) three months after having the transplant; (iv) and annually thereafter until death. These data are transferred on a monthly basis to the UK Cardiothoracic Transplant Audit team based at the Clinical Effectiveness Unit (CEU) of the Royal College of Surgeons of England (RCS). The data submitted are subjected to on-going process of validation including the use of computer-based validation and case notes reviews, and as a

The database held by NHSBT / Royal College of Surgeons Clinical Effectiveness Unit forms the basis of the UK Cardiothoracic Transplant Audit. The UK Cardiothoracic Transplant Audit is a multi-centre prospective cohort study. The audit has donor, recipient and outcome data on all cardiothoracic transplants undertaken in the UK since July 1995 and allows for prospective and retrospective audit of the outcomes from cardiothoracic transplantation. Because the data are collected in a timely manner as outlined above the data collected also allows real-time monitoring of outcomes for each transplant centre that can be

The audit is undertaken by a project team, overseen by a steering group, comprising the directors of all cardiopulmonary transplant centres in the UK, the director of the Royal College of Surgeons Clinical Effectiveness Unit, and representatives from NHSBT and the National Specialised Commissioning Team. The Steering Group approves all output from

The UK Cardiothoracic Transplant Audit publishes on an annual basis the 30-day, 90-day, 1 year, 3-year, 5-year and 10-year mortality after first intrathoracic transplantation at all cardiopulmonary transplant centres in the United Kingdom. Centre-specific 30-day and 90 day mortality is reported for the more recent cohorts with 1-year and 3-year mortality being presented for the most appropriate recent cohort as well as for the period as a whole. Five and 10-year mortality rates are reported for the entire period as a whole. The Audits are available on the Royal College of Surgeons of England website (www.rcseng.ac.uk/surgical\_research\_units/ceu/docs.html) (see Rogers et al., 2010). Results for adult (age ≥ 16 years at transplant) heart and lung transplants and paediatric heart and lung transplants are reported separately. The results for 30-day, 90-day and 1-year mortality after adult heart transplantation and 30-day and 90-day mortality after adult lung transplantation are presented both with and without adjustment for case-mix. The risk models used for case-mix adjustment have all been developed specifically for this audit. The risk-adjusted estimates of early mortality after adult heart transplant for the most recent cohort of patients available (April 2007 – March 2010 [December 2009 for 90-day mortality])

Figures 1 and 2 highlight that both the 30-day and 90-day mortality for each centre in the UK is within the range expected with no centre experiencing a mortality that was lower or

present day.

result are robust and reliable.

used for monitoring performance.

the audit prior to publication.

are shown as funnel plots in Figures 1 and 2.

higher than expected.

Note: Solid and dashed lines define the 95% and 99% confidence intervals

Fig. 1. Risk-adjusted estimates of early (30-day) mortality after adult heart transplantation, April 2007 – March 2010 (reproduced from the RCS / NHSBT UK Cardiothoracic Transplant Audit, August 2010, (Rogers et al., 2010)).

Data collected since January 2004 are used to continuously monitor 30-day and 90-day mortality, and presented both as a cumulative observed-expected (O-E) mortality and tabular CUSUM in the Annual Audit. For the adult transplant programmes the cumulative observed-expected mortality is presented both with and without risk adjustment. Paediatric recipient outcomes are only presented without risk adjustment.

In addition to the CUSUM monitoring presented in the annual report of the audit, real-time CUSUM monitoring has also been performed on a monthly basis since October 2006. This is especially important because it allows real-time monitoring of mortality outcomes and allows timely identification of any unexpected changes in mortality rates.

The O-E mortality chart plots the cumulative difference between the observed and expected patient mortality. For the continuous monitoring programme expected mortality rates are based on the national average mortality rate for transplants performed between 2000 and 2003, with more recent transplants given more weight. If the trend in the O-E chart goes downwards then this would indicate that the mortality rate observed is lower than might be expected, whilst an upward trend would suggest an observed mortality rate that is higher than expected.

An example of an O-E cumulative mortality chart for the five English centres is given in Figure 3.

Note: Solid and dashed lines define the 95% and 99% confidence intervals

Fig. 2. Risk-adjusted estimates of early 90-day mortality after adult heart transplantation, April 2007 – December 2009 (reproduced from the RCS / NHSBT UK Cardiothoracic Transplant Audit, August 2010, (Rogers et al., 2010)).

The tabular CUSUM chart is used to signal when a significant increase in mortality rate has been observed. The chart limit is set to signal when there is sufficient evidence to indicate that the mortality rate has doubled. A signal may indicate divergence from the national average. If an individual centre's CUSUM chart signals then following any appropriate investigation to understand what might have caused the signal, the CUSUM chart is reset to enable closer monitoring of the centre's performance in the following months.

Examples of tabular CUSUMs included in the most recent Royal College of Surgeons and NHSBT UK Cardiothoracic Transplant Audit, August 2010, (Rogers et al., 2010) for the 5 English adult cardiothoracic transplant centres are given in Figure 3 (30-day mortality) and Figure 4 (90-day mortality).

The CUSUM charts illustrate that recent 30 and 90-day mortality rates following adult heart transplantation have been as expected at Centre 1, Centre 4 and Centre 5.

However, they also show that Centre 2 experienced more deaths than might be expected in 2007 and Centre 3 experienced more deaths than might be expected in 2008. In all cases, the CUSUM charts signalled and the centres underwent an external review of their service. Since the signals, the 30-day mortality rates have returned to the expected level at each centre. After the signal in 2008, Centre 3 continued to experience more deaths within 90 days

Newcastle

0 20 40 60 80 100 120 Number of transplants

Fig. 2. Risk-adjusted estimates of early 90-day mortality after adult heart transplantation, April 2007 – December 2009 (reproduced from the RCS / NHSBT UK Cardiothoracic

The tabular CUSUM chart is used to signal when a significant increase in mortality rate has been observed. The chart limit is set to signal when there is sufficient evidence to indicate that the mortality rate has doubled. A signal may indicate divergence from the national average. If an individual centre's CUSUM chart signals then following any appropriate investigation to understand what might have caused the signal, the CUSUM chart is reset to

Examples of tabular CUSUMs included in the most recent Royal College of Surgeons and NHSBT UK Cardiothoracic Transplant Audit, August 2010, (Rogers et al., 2010) for the 5 English adult cardiothoracic transplant centres are given in Figure 3 (30-day mortality) and

The CUSUM charts illustrate that recent 30 and 90-day mortality rates following adult heart

However, they also show that Centre 2 experienced more deaths than might be expected in 2007 and Centre 3 experienced more deaths than might be expected in 2008. In all cases, the CUSUM charts signalled and the centres underwent an external review of their service. Since the signals, the 30-day mortality rates have returned to the expected level at each centre. After the signal in 2008, Centre 3 continued to experience more deaths within 90 days

enable closer monitoring of the centre's performance in the following months.

transplantation have been as expected at Centre 1, Centre 4 and Centre 5.

Papworth

Birmingham

Harefield

Glasgow

Gt Ormond St

Figure 4 (90-day mortality).

0

5

10

15

% mortality

20

25

Manchester

Note: Solid and dashed lines define the 95% and 99% confidence intervals

Transplant Audit, August 2010, (Rogers et al., 2010)).

Fig. 3. Cumulative (observed - expected) 30-day mortality after adult heart transplantation, January 2004 to March 2010(reproduced from the RCS and NHSBT UK Cardiothoracic Transplant Audit, August 2010, (Rogers et al., 2010)).

than expected and the 90-day CUSUM chart signalled again. This is because centres are monitored more closely after a signal and the charts are more sensitive.

#### **2.1 Outcome monitoring to ensure maintenance of high quality clinical services**

Real-time monitoring of mortality outcomes after heart and lung transplants have led to several reviews of services to understand why variation from expected might have occurred, and to put in place appropriate action plans when necessary. The conclusions of such reviews are published on the National Specialised Commissioning Team's website and are available at www.specialisedservices.nhs.uk.

Included below are some extracts taken from an external review undertaken at Harefield Hospital in 2008, the full report of which is in the public domain and available on the National Specialised Commissioning Team's website (NSCT, 2008). It outlines the background to the review and summarises the additional statistical analyses undertaken on the mortality data available for the service. The extracts below do not include the elements of the actual external review process, the details of which are available in the full report.

These highlight how rapid further analysis of available data can be undertaken to help understand why variability in outcomes might have occurred and demonstrate how this

Fig. 4. Tabular CUSUM for 30-day mortality after adult heart transplant unadjusted for patient risk, January 2004 to March 2010 (reproduced from the RCS / NHSBT UK Cardiothoracic Transplant Audit, August 2010, (Rogers et al., 2010)).

understanding can then be used by clinicians and commissioners to support any necessary service changes.

One of the strengths of National Specialised Commissioning is the relationship and understanding that is built up between the commissioning team (medical advisor, commissioning manager and finance manager) with the clinical teams providing the service. This is exemplified in this example by the fact that the clinical team alerted the National Specialised Commissioning Team to a potential issue ahead of any alert signalling at NHSBT, demonstrating good clinical practice.

**Centre 1 Centre 2 Centre 3**

Fig. 4. Tabular CUSUM for 30-day mortality after adult heart transplant unadjusted for patient risk, January 2004 to March 2010 (reproduced from the RCS / NHSBT UK

understanding can then be used by clinicians and commissioners to support any necessary

**Transplant number** 

One of the strengths of National Specialised Commissioning is the relationship and understanding that is built up between the commissioning team (medical advisor, commissioning manager and finance manager) with the clinical teams providing the service. This is exemplified in this example by the fact that the clinical team alerted the National Specialised Commissioning Team to a potential issue ahead of any alert signalling at

Cardiothoracic Transplant Audit, August 2010, (Rogers et al., 2010)).

**Centre 4 Centre 5** 

NHSBT, demonstrating good clinical practice.

service changes.

Fig. 5. Tabular CUSUM for 90-day mortality after adult heart transplant unadjusted for patient risk, January 2004 to March 2010 (reproduced from the RCS / NHSBT UK Cardiothoracic Transplant Audit, August 2010, (Rogers et al., 2010)).

Extracts as follows (Please note that all figures referred to have not been included in these extracts but are available in the full report available at http://www.specialisedservices.nhs.uk/document/review-recent-outcomes-in-hearttransplant-service-at-harefield-hospital)*.* (NSCT, 2008)

## *NATIONAL COMMISSIONING GROUP (NCG) REPORT OF THE EXTERNAL REVIEW OF RECENT OUTCOMES IN THE HEART TRANSPLANT SERVICE AT HAREFIELD HOSPITAL (2008)*
