Nicholas Winterton
PFD Report
Partially Responded
Ref: 2021-0204
Coroner's Concerns (AI summary)
The nationally recognized risk level for Mycobacterium Chimaera infection is inaccurate and outdated, leading to inadequate informed consent and a low threshold of suspicion among clinicians.
View full coroner's concerns
In the course of the inquest the evidence revealed matters giving rise to concern. In my opinion there is a risk that future deaths could occur unless action is taken. 1. It is apparent that it is important that the nationally recognised level of the risk of developing Mycobacterium Chimaera from exposure to a heater cooler unit is accurate, in that it accurately reflects the most current statistical data, and is based on the best gathering of statistical data as to the true incidence of such infection as can practicably be achieved. This is because the nationally recognised level of risk is the proper basis upon which – (i) The informed consent of a patient for a relevant surgery is obtained, and (ii) Post-operatively, the patient and the clinician(s) caring for him (including his General Practitioner) will base their “threshold for suspicion” for Mycobacterium Chimaera if the patient develops an infection which cannot quickly be identified and treated.
2. Public Health England, together with the National Institute for Cardiovascular Outcomes Research, the Society for Cardiothoracic Surgery, and the College of Clinical Perfusion Scientists, are the national bodies which are able to co-ordinate collation of relevant statistical evidence and then formulate and disseminate accurate information about the level of risk. It is inappropriate for individual hospitals, cardiac centres, or Trusts to formulate risk level on the basis of their own data as this would result, nationally, in the dissemination of inconsistent information.
3. Public Health England’s “Clinical guidance for secondary care” and “Information for general practice” are based on January 2017 data. Further, on its website, under the heading “Who could be at risk of Mycobacterium chimaera infection”, Public Health England currently states, “People most at risk are those who’ve had heart valve surgery since January 2013. About 1 person in every 5,000 who has this type of surgery will develop the infection.”
This assessment is also based on data collated to January 2017.
4. The evidence at the inquest showed that the figure of “1 person in every 5,000” is inaccurate, in that : (i) It is based on data from 2017 and not updated data, and (ii) It is based on data which reflects only those patients who are reported to Public Health England as having died of Mycobacterium Chimaera infection, whereas the true incidence of the infection is very likely to be higher; the likelihood is that there is a potentially significant number of deaths from undiagnosed Mycobacterium Chimaera, given the patient cohort’s usual level of co-morbidities and clinicians’ low threshold of suspicion for this infection.
5. A more accurate assessment of the risk, and more accurate guidance, would therefore result from – (i) An immediate review by Public Health England of all data held to date with a re-calculation of the incidence of Mycobacterium Chimaera infection and consequential risk being reflected in updated guidance and web-site information, and (ii) Consideration being given by all the bodies to whom this Report is sent of whether there is a better investigative basis which could be used for obtaining relevant data and statistics as to the true incidence of Mycobacterium Chimaera infection, whether by means of a research study or otherwise.
2. Public Health England, together with the National Institute for Cardiovascular Outcomes Research, the Society for Cardiothoracic Surgery, and the College of Clinical Perfusion Scientists, are the national bodies which are able to co-ordinate collation of relevant statistical evidence and then formulate and disseminate accurate information about the level of risk. It is inappropriate for individual hospitals, cardiac centres, or Trusts to formulate risk level on the basis of their own data as this would result, nationally, in the dissemination of inconsistent information.
3. Public Health England’s “Clinical guidance for secondary care” and “Information for general practice” are based on January 2017 data. Further, on its website, under the heading “Who could be at risk of Mycobacterium chimaera infection”, Public Health England currently states, “People most at risk are those who’ve had heart valve surgery since January 2013. About 1 person in every 5,000 who has this type of surgery will develop the infection.”
This assessment is also based on data collated to January 2017.
4. The evidence at the inquest showed that the figure of “1 person in every 5,000” is inaccurate, in that : (i) It is based on data from 2017 and not updated data, and (ii) It is based on data which reflects only those patients who are reported to Public Health England as having died of Mycobacterium Chimaera infection, whereas the true incidence of the infection is very likely to be higher; the likelihood is that there is a potentially significant number of deaths from undiagnosed Mycobacterium Chimaera, given the patient cohort’s usual level of co-morbidities and clinicians’ low threshold of suspicion for this infection.
5. A more accurate assessment of the risk, and more accurate guidance, would therefore result from – (i) An immediate review by Public Health England of all data held to date with a re-calculation of the incidence of Mycobacterium Chimaera infection and consequential risk being reflected in updated guidance and web-site information, and (ii) Consideration being given by all the bodies to whom this Report is sent of whether there is a better investigative basis which could be used for obtaining relevant data and statistics as to the true incidence of Mycobacterium Chimaera infection, whether by means of a research study or otherwise.
Responses
Action Planned
PHE will update risk estimates for Mycobacterium chimaera infection and publish them by September 2021, cascading the information to healthcare professionals through clinical networks; they will forward the request to update NHS guidance to NHS England. (AI summary)
PHE will update risk estimates for Mycobacterium chimaera infection and publish them by September 2021, cascading the information to healthcare professionals through clinical networks; they will forward the request to update NHS guidance to NHS England. (AI summary)
View full response
1
Healthcare-Associated Infection & Antimicrobial Resistance Division National Infection Service 61 Colindale Avenue London NW9 5EQ
8 June 2021
Regulation 28 report dated 31 March 2021 to prevent future deaths pursuant to Her Majesty's Coroner inquest into the death of Nicholas Winterton
Patient’s Name: Nicholas Hugh Winterton
Date of death: 29.09.2018
Response from: Public Health England (“PHE”); National Institute for Cardiovascular Outcomes Research; Society for Cardiothoracic Surgery (“SCTS”); and College of Clinical Perfusion Scientists
1) The Coroner has asked for actions to be taken, without which in her opinion, there is a risk that future deaths could occur from Mycobacterium chimaera infection acquired during cardiac surgery. These relate to a perceived inaccuracy in the risk estimate of “1 person in every 5,000” published by PHE in 2017 in its guidance to primary and secondary care providers and on its website. In summary, this inaccuracy is stated as stemming from:
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(i) being based on data from 2017 and not updated data, and (ii) being based on data which reflects only those patients who are reported to PHE as having died of Mycobacterium chimaera infection.
2) In relation to the above, the Coroner has requested (in summary): (i) a review of all data held to date with a recalculation of the incidence of infection and dissemination of the consequential risk assessment through updated guidance and website information, and (ii) consideration as to the optimal investigative basis for formulating this risk assessment. Inaccuracy in calculation of Mycobacterium chimaera infection risk
3) With regard to the concern in paragraph (1)(ii) above, we would like to clarify to the Coroner that these risk calculations were not based solely on risk of death but in fact based on risk of infection associated with this type of surgery, namely heart-valve surgery performed on bypass. As such, data collection was not restricted to patients reported to PHE as having died of Mycobacterium chimaera (M. chimaera) infection.
4) In responding to the potential threat posed by transmission of M. chimaera from contaminated heater cooler units (“HCUs”) used in open-heart surgery, PHE established a surveillance system to capture data on all cases (not just cases resulting in death) potentially arising as a result of open-heart surgery performed in the UK. PHE continues to collate and publish information on newly diagnosed cases and associated deaths. This can be found on:
3
with-heater-cooler-units.
5) With regard to the concern in paragraph (1)(i) above, this risk was estimated to support the nationwide patient notification exercise mounted in 2017. The risk estimate is not inaccurate; it refers to an estimated risk of Mycobacterium chimaera (M. chimaera) infection for patients who underwent NHS surgery between 2007 and
2015. Based on cases reported to PHE to date, the risk for patients undergoing surgery during that period remains unchanged at 1 in 5000. Proposed actions to be taken
6) With reference to the proposed updating of risk estimates referred to in paragraph (2)(i) above, PHE has continued to monitor changes in risk, utilising cases reported to PHE coupled with numbers of patients undergoing heart-valve surgery in NHS hospitals derived from Hospital Episode Statistics. This has shown a continued decline in risk with successive years of surgery since 2014. The most recent date of surgery for cases identified to date is February 2017. Therefore there have been over four years of cardiac surgery performed in the United Kingdom without a further case of M. chimaera identified to date.
7) With reference to paragraph (2)(ii) above and given that the current methodology includes surveillance data not just restricted to deaths, the respondent bodies believe the established mechanism provides a reasonable means for ongoing monitoring of risk and that a revised or alternative investigative basis is not required.
8) PHE accepts that information on the risks of infection should be more widely disseminated to inform patients’ decision-making, and for clinical awareness. An
4
updated risk assessment was undertaken by PHE in November 2019 and submitted to an international medical conference with a view to publication of an article in a medical journal. An extract from the conference abstract book is attached at Exhibit PHE11. The advent of the COVID-19 pandemic resulted in the cancellation of the conference and delayed completion of the publication.
9) PHE will further update the risk estimates and ensure that these are published by September 2021. The respondent bodies will thereafter cascade these updated risk estimates to healthcare professionals involved in informing and consenting patients or investigating and diagnosing these infections, namely consultant microbiologists and cardiothoracic surgeons. This will be achieved through our respective clinical networks.
10) In relation to the updating of the guidance for healthcare providers, we would like to make the Coroner aware that NHS England assumed responsibility for management of the M. chimaera incident in October 2016. PHE and SCTS worked with NHS England to support the patient notification exercise launched in February 2017, including the development of guidance for healthcare providers.
11) With specific reference to the inclusion of the 1 in 5000 risk estimate on PHE’s website, whilst the risk estimate was produced by PHE, we believe this information is in fact found on the NHS website (which is not controlled by PHE):
1 The ECCMID Abstract Book from which the extract is taken can be downloaded from the following website:
5
12) Given the transfer of responsibility for management for the incident, we will forward this request for the further updating of guidance and to the need to update the NHS website to NHS England to agree responsibilities and a timetable for updating.
6
Exhibit PHE1
7
Healthcare-Associated Infection & Antimicrobial Resistance Division National Infection Service 61 Colindale Avenue London NW9 5EQ
8 June 2021
Regulation 28 report dated 31 March 2021 to prevent future deaths pursuant to Her Majesty's Coroner inquest into the death of Nicholas Winterton
Patient’s Name: Nicholas Hugh Winterton
Date of death: 29.09.2018
Response from: Public Health England (“PHE”); National Institute for Cardiovascular Outcomes Research; Society for Cardiothoracic Surgery (“SCTS”); and College of Clinical Perfusion Scientists
1) The Coroner has asked for actions to be taken, without which in her opinion, there is a risk that future deaths could occur from Mycobacterium chimaera infection acquired during cardiac surgery. These relate to a perceived inaccuracy in the risk estimate of “1 person in every 5,000” published by PHE in 2017 in its guidance to primary and secondary care providers and on its website. In summary, this inaccuracy is stated as stemming from:
2
(i) being based on data from 2017 and not updated data, and (ii) being based on data which reflects only those patients who are reported to PHE as having died of Mycobacterium chimaera infection.
2) In relation to the above, the Coroner has requested (in summary): (i) a review of all data held to date with a recalculation of the incidence of infection and dissemination of the consequential risk assessment through updated guidance and website information, and (ii) consideration as to the optimal investigative basis for formulating this risk assessment. Inaccuracy in calculation of Mycobacterium chimaera infection risk
3) With regard to the concern in paragraph (1)(ii) above, we would like to clarify to the Coroner that these risk calculations were not based solely on risk of death but in fact based on risk of infection associated with this type of surgery, namely heart-valve surgery performed on bypass. As such, data collection was not restricted to patients reported to PHE as having died of Mycobacterium chimaera (M. chimaera) infection.
4) In responding to the potential threat posed by transmission of M. chimaera from contaminated heater cooler units (“HCUs”) used in open-heart surgery, PHE established a surveillance system to capture data on all cases (not just cases resulting in death) potentially arising as a result of open-heart surgery performed in the UK. PHE continues to collate and publish information on newly diagnosed cases and associated deaths. This can be found on:
3
with-heater-cooler-units.
5) With regard to the concern in paragraph (1)(i) above, this risk was estimated to support the nationwide patient notification exercise mounted in 2017. The risk estimate is not inaccurate; it refers to an estimated risk of Mycobacterium chimaera (M. chimaera) infection for patients who underwent NHS surgery between 2007 and
2015. Based on cases reported to PHE to date, the risk for patients undergoing surgery during that period remains unchanged at 1 in 5000. Proposed actions to be taken
6) With reference to the proposed updating of risk estimates referred to in paragraph (2)(i) above, PHE has continued to monitor changes in risk, utilising cases reported to PHE coupled with numbers of patients undergoing heart-valve surgery in NHS hospitals derived from Hospital Episode Statistics. This has shown a continued decline in risk with successive years of surgery since 2014. The most recent date of surgery for cases identified to date is February 2017. Therefore there have been over four years of cardiac surgery performed in the United Kingdom without a further case of M. chimaera identified to date.
7) With reference to paragraph (2)(ii) above and given that the current methodology includes surveillance data not just restricted to deaths, the respondent bodies believe the established mechanism provides a reasonable means for ongoing monitoring of risk and that a revised or alternative investigative basis is not required.
8) PHE accepts that information on the risks of infection should be more widely disseminated to inform patients’ decision-making, and for clinical awareness. An
4
updated risk assessment was undertaken by PHE in November 2019 and submitted to an international medical conference with a view to publication of an article in a medical journal. An extract from the conference abstract book is attached at Exhibit PHE11. The advent of the COVID-19 pandemic resulted in the cancellation of the conference and delayed completion of the publication.
9) PHE will further update the risk estimates and ensure that these are published by September 2021. The respondent bodies will thereafter cascade these updated risk estimates to healthcare professionals involved in informing and consenting patients or investigating and diagnosing these infections, namely consultant microbiologists and cardiothoracic surgeons. This will be achieved through our respective clinical networks.
10) In relation to the updating of the guidance for healthcare providers, we would like to make the Coroner aware that NHS England assumed responsibility for management of the M. chimaera incident in October 2016. PHE and SCTS worked with NHS England to support the patient notification exercise launched in February 2017, including the development of guidance for healthcare providers.
11) With specific reference to the inclusion of the 1 in 5000 risk estimate on PHE’s website, whilst the risk estimate was produced by PHE, we believe this information is in fact found on the NHS website (which is not controlled by PHE):
1 The ECCMID Abstract Book from which the extract is taken can be downloaded from the following website:
5
12) Given the transfer of responsibility for management for the incident, we will forward this request for the further updating of guidance and to the need to update the NHS website to NHS England to agree responsibilities and a timetable for updating.
6
Exhibit PHE1
7
Sent To
- Public Health England
Response Status
Linked responses
1 of 4
56-Day Deadline
23 Aug 2021
About PFD responses
Organisations named in PFD reports must respond within 56 days explaining what actions they are taking.
Source: Courts and Tribunals Judiciary
Report Sections
Investigation and Inquest
I commenced an investigation into the death of Nicholas Hugh Winterton. The investigation concluded at the end of the inquest on the 17th December 2020. The conclusion of the inquest was that the medical cause of death was - Ia Chronic Systemic Sepsis and Multi-organ Failure Ib Mycobacterium Chimaera Endocarditis Acquired During Cardiac Bypass Surgery Ic Aortic Valve Disease (Operated in May 2016) II Cerebral Infarction and my conclusion as to the death was that the Deceased – Died as a result of infection from equipment used in necessary surgical treatment.
Circumstances of the Death
Nicholas Winterton suffered severe aortic regurgitation and on the 20th May 2016 at St. Bartholomew's Hospital, London, he underwent elective aortic valve replacement surgery, for which purpose he was placed on cardiopulmonary bypass. The surgery was uneventful and the Deceased made a good post-operative recovery. In May 2018, however, he became unwell with symptoms of infection; whilst still under investigation for those symptoms, on the 31st May 2018 he suffered a stroke and was admitted to hospital, and subsequently, on the 29th June 2018, he was transferred to the National Hospital for Neurology and Neurosurgery, London. By mid-July 2018 blood cultures had established that the Deceased's infection was from mycobacterium chimaera and he was suffering infective endocarditis. Surgical intervention was judged not to be feasible; he was treated with an appropriate anti-biotic regime but it proved ineffective and he developed systemic inflammatory response syndrome, sepsis, and multi-organ failure, from which he died on the 29th September 2018. The mycobacterium chimaera infection had been acquired from the heater-cooler unit which was used as an essential part of the cardiopulmonary bypass equipment for his cardiac surgery in May 2016. The heightened risk of this infection from this device, which stemmed principally from its design, had been identified prior to the surgery, including through guidance for minimising the risk issued in October 2015 by Public Health England. St. Bartholomew's Hospital's systems were largely in compliance with that guidance, although their regular decontamination of their heater-cooler units was performed on about a monthly basis, rather than two-weekly as recommended by the manufacturer. The evidence did not reveal which unit was used for the Deceased's surgery, as this was not recorded as required, and it was not possible to establish what, if any, effect the hospital's cleaning regime had on the risk of infection from the operation.
Action Should Be Taken
In my opinion action should be taken to prevent future deaths by addressing the concerns set out above and I believe your organisation have the power to take such action.
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Data sourced from Courts and Tribunals Judiciary under the Open Government Licence.