Norman Pirie

19 March 2019 

PRIVATE & CONFIDENTIAL 

Mr Edwin Buckett 
Assistant Coroner for Inner North London  
St Pancras Coroner’s Court  

Trust Executive Office 
Ground Floor 
Pathology and Pharmacy Building 
The Royal London Hospital 
80 Newark Street 
London E1 2ES 

Telephone: 020 32460641 

Chief Medical Officer 
Alistair Chesser 

www.bartshealth.nhs.uk 

Dear Mr Buckett 

RE: Regulation 28 Prevention of Future Deaths Report: Norman Joseph Pirie 

I write in response to your Regulation 28: Report to Prevent Future Deaths, dated 18 January 2019.  
Your concerns are related to device selection in Endovascular surgery.  

The  Royal  London  Hospital,  Barts  Health  NHS Trust,  has  been  a  vascular surgery  hub for  over 20 
years,  throughout  which  it  has  adhered  to  the  required  governance  processes.  In  recent  years, 
vascular  technologies  have  evolved,  resulting  in  more  endovascular  and  fewer  open  surgical 
treatments. In response to this, we have a dynamic infrastructure to allow an equivalent fluidity in our 
governance processes to ensure patient safety remains our paramount concern. Models of vascular 
practice encourage working within networks to centralise expertise and infrastructure. The Vascular 
Society,  GIRFT  (2018)1  and  a  recent  Vascular  Surgery  Service  Specification  (2017)2,3  describe 
operational aspects of practice to influence best practice that is safe for patients. The Vascular Unit 
at Barts Health NHS Trust adheres to all of these standards of practice. 

Endovascular  (EVAR)  technologies  have  changed  management  of  Abdominal  Aortic  Aneurysms 
(AAA),  having  shown  it  to  have  a  30  day  mortality  of  1.8%4.  There  is  strict  guidance  on  AAA 
threshold  for  treatment;  the  shape  of  AAA  for  EVAR;  and  patient  fitness  from  evidence  produced 
nationally3 and internationally over the last 25 years. The low 30 day mortality means it is a desirable 
option in the less fit patients who would otherwise have no option for treatment.  Over the years, the 
technology  has  been  cautiously  extended  in  more  complex  situations  including  patients  with  less 
suitable anatomy as defined in the instructions for use (IFU) of endografts. There are many studies 
that  demonstrate  that  EVAR  can  be  performed  safely  in  high-risk  patients  with  unfavourable  neck 
anatomy  using  commercially  available  endografts,  and  that  such  patients  are  capable  of  achieving 
mid-term outcomes that are comparable to those achieved in patients with suitable anatomy.5  

Current practice: 
Once the diagnosis of AAA has been made and the case has been referred to vascular surgery, it is 
discussed in the weekly Multi-disciplinary Team Meeting (MDT):  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   Computed  Tomography  (CT)  angiogram 

findings  are  discussed  between  Vascular 

Interventional Radiologists and Vascular Surgery Consultants. 

  Discussions centre broadly around the choice of open surgical and endovascular options, or 

conservative management.  

  Some  discussion  can  be  around  particular  technical  solutions  within  those  treatment 
modalities. Some of the more complex cases are also reviewed outside of the MDT to further 
assess  the  more  complex  technical  solutions.    We  always  look  for  solutions  with  devices 
within  their  IFU.  We  will  consider  other  options  if  no  IFU  compliant  device  is  available, 
including no intervention and open surgery. However, non IFU treatment remains a possible 
solution  in  certain  scenarios  based  on  clinical  judgement,  using  our  own  institutional 
experience and the plethora of available literature.  

  Outcome of discussion is recorded in the patient’s electronic clinical record (CRS). 
  The  outputs  of  the  MDT  are  then  set  up  e.g.  Outpatient  clinic  review,  High  risk  pre-

assessment, book for intervention, other investigations and return to MDT 

Final management: 

Intervention ( Open or Endovascular) 

 
  Surveillance (with view to future intervention) 
  No intervention 

In Mr Pirie’s case: 

  A (usually benign, Type 2 endoleak) backflow of blood from a branch of the aorta back into 
the aneurysm sac was causing progressive expansion of the aneurysm and a low risk attempt 
at endovascular embolization of this vessel had not been successful. 

  Mr  Pirie  was  closely  monitored  until  the  aneurysm  had  expanded  to  the  point  where  it  was 
now  leaking  around  the  side  of  the  stent  at  the  proximal  seal  with  a  sac  size  of  90mm  and 
4mm  increase  in  4  months.  This  made  him  extremely  high  risk  for  rupture  within  a  short 
timeframe due to the lethal triad of absolute size of the aneurysm; the mechanism of increase 
(Type 1A endoleak) and rate of expansion.  

  A re-intervention was offered in this context, as when the aneurysm were to actually rupture, 
his  mortality  would  be  in  the  90%-100%  range.  Even  then,  his  re-intervention  was  delayed 
due  to  a  further  deterioration  in  his  fitness,  resulting  in  a  cardiologist  assessment  and 
stratification as substantial risk for the endovascular procedure as discussed with the patient 
directly and confirmed by letter 

 
 
 
 
 
 
   For all of the above reasons, although the procedure was performed on an elective list, the 
risk  of  the  procedure  was  presented  as  high;  but  not  as  high  as  treating  conservatively 
without a procedure. 

  Given Mr Pirie’s anaesthetic assessment, the alternative possible repair options - Fenestrated 
Endovascular  Aortic  Repair  (FEVAR)  and  open  surgery  –  were  known  to  be  too  high  risk 
given the complexity of both.  

  The use of EVAR devices outside of the IFU is an accepted practice. The literature presented 
at the inquest was submitted to support this (attached). Extensive literature can be found on 
this. 

  The concern of using devices outside of IFU is one primarily of longevity of seal. 
 

In Mr Pirie’s case, given the above, the options were only those that were undertaken or no 
intervention at all. Given the institutional and world experience, there was no undue concern 
that the device would not deploy because of the given angulation.  

Proposal 

We  feel  that  our  processes  are  generally  robust  and  in  keeping  with  the  other  vascular 
institutions across the country. However, on reflection, the communication can be enhanced 
by the following: 

  We  will  implement  steps  to  improve  the  pathway  around  points  of  communication  between 

clinicians, GP and the patient. 

  We  will  institute  a  separate  planning  meeting  outside  of  the  MDT.    Here  the  nuanced 

technical discussions on the type of stent and manufacturer can be expanded. 

  We will move to joint planning meetings between IR and Vascular surgery consultants so that 
the issues of IFU can be discussed formally. This will enable longer joint discussions around 
particular devices and their suitability, based on IFU, and durability.   
  The results of the planning meeting will then be fed back into the MDT.  
  Where no IFU compliant option is available, we will re-discuss in the MDT to consider other 
options, i.e. no intervention or open surgery.  However, non IFU treatment remains a possible 
solution in certain scenarios particularly urgent and emergency cases. While it is natural for 
the manufacturers to point out any deviance from Instructions For Use in the event of device 
failure, it is our opinion, based on our clinical experience of the peer-reviewed published body 
of  evidence,  that  increased  angulation  of  the  aorta  is  unlikely  to  have  been  a  factor  in  the 
failure of the device to deploy in this case 

  The  decision  will  be  recorded  in  the  patient’s  Clinical  Record.  The  patient  and  GP  will  be 

notified with an output from the MDT. 

 
 
 
 
 
   Discussion  around  this  MDT  outcome  will  be  undertaken  with  the  patient  in  the  outpatients 
setting. The patient will receive an explanation regarding the available treatment options and 
the risks and benefits of each. If an endovascular solution outside of IFU is proposed, this will 
be made clear to the patient and the discussion recorded. 

Thank you for bringing your concerns to my attention.  I trust that you are assured I have taken them 
seriously and investigated them appropriately. 

Yours sincerely 

Alistair Chesser 
Chief Medical Officer  
Barts Health NHS Trust 

CC:  
Simon Harrod, Medical Director, Royal London Hospital 
Legal Team, Barts Health NHS Trust  

References: 

1.  Getting it right first time (GIRFT): Vascular surgery National Report 2018. 

www.gettingitrightfirsttime.co.uk 

2.  Specialised Vascular Services. NHS England 2017 
3.  Top tips’ for reconfiguring Vascular Services 2018 
4.  Endovascular versus Open repair of Abdominal aortic aneurysms. The UK EVAR trial Investigators. N 

Eng J Med 2010; 362:1863-1871 

5.  EVAR Deployment in Anatomically Challenging Necks Outside the IFU. J.T. Lee *, B.W. Ullery, C.K. 

Zarins, C. Olcott, IV, E.J. Harris, Jr., R.L. Dalman; Eur J of Vasc and Endovasc Surg;  Volume 46 Issue 
1, July 2013