Sandra Higham

BHRS

British Heart Rhythm Society

PO Box 3697
Stratford upon Avon
CV37 8YL

19" December 2014
Ms Henrietta Hill
Assistant Coroner
Inner South London Coroner’s Court
1 Tennis Court

London
SE1 1YD

Dear Ms Hill

REPORT ON DEVELOPMENT OF ATRIO-OESOPHAGEAL FISTULA
FOLLOWING ABLATION FOR ATRIAL FIBRILLATION

Ablation as a therapeutic option for the management of atrial fibrillation (AF) is an
increasingly common procedure undertaken for patients with significant symptoms secondary
to this arrhythmia. In the UK, some 6,000 catheter based ablation procedures were
undertaken for AF from April 2013 to March 2014. There are recognised risks associated
with this procedure: recent reported evidence shows that atrio-oesophageal fistula occurs in
0.04% of patients,! although this is likely to be an underestimate and the actual incidence is
probably between 0.1 and 0.2%. This complication always presents sometime after the
procedure, Other complications, such as pulmonary vein stenosis or Dressler’s syndrome
will also have a delay to presentation. The British Heart Rhythm Society (BHRS) is of the
opinion that there are two areas that can be looked at to help reduce this complication.
Procedural considerations include an awareness of the risk of this complication, reduction /
titration and location of energy delivered. However, there is no evidence that newer ablation
technologies or other strategies such as oesophageal temperature monitoring, make a
significant difference to the occurrence of this complication. Operators should be aware that
they need to limit the amount of ablation that takes place to the posterior wall of the left
atrium and be aware of the possibility of this complication. BHRS believes that colleagues
who perform this procedure are aware of this complication and take appropriate steps to

reduce the likelihood of its occurrence.

i Cappato R, Calkins H, Chen SA, et al. Updated worldwide survey on the methods, efficacy, and safety of
catheter ablation for human atrial fibrillation. Cire Arrhythm Electrophysiol 2010; 3: 32-8.

-1-

The second area is patient education and this is likely to be of more benefit. Patients can be
made more aware of this complication and also warning signs such as fever, epigastric pain,
headache etc. They need to be told in this situation to (a) go to their local emergency
department immediately and (b) they should contact the centre where the ablation was
performed. We feel we should work with our sister organisations, the AF Association and
the Arrhythmia Alliance (A-A) both of which are patient orientated organisations to improve
the information and education patients are given; the information leaflets and on line
information produced by these organisations will be amended to reflect this. We will work to
develop a leaflet which can be downloaded from these sites. Patients could be issued with
this on discharge following their AF ablation, giving information as to what symptoms to be
aware of and advice to medical teams as to how to investigate and manage this complication,

together with contact details for the ablation centre.

PROPOSED ACTIONS

e BHRS will include an article on avoidance and recognition of atrio-oespohageal
fistula in its winter newsletter which is circulated to all BHRS members in January
and remind its members to ensure this complication is recorded in the national cardiac
rhythm management database for which BHRS and the National Institute for
Cardiovascular Research (NICOR) are responsible.

e BHRS will work with the AF Association and A-A to re-design the patient
information relating to complications of AF ablation to include information on
recognition of symptoms associated with the complication. As part of this, a leaflet
will be developed, as detailed above, which will be able to be downloaded from the
AF Association, A-A and BHRS websites to be given to patients on discharge
following their AF ablation. This should be able to be completed by the end of March
2015.

Yours sincerely

President, British Heart Rhythm Society

From Dr Dan Poulter MP
Parliamentary Under Secretary of State for Health

Department Richmond House
of Health aaa
POCS 898876 SWIA 2NS

Tel: 020 7210 4850

Ms H Hill

Assistant Coroner

Southwark Coroner’s Court

1 Tennis Street

Southwark 17 MAR 2015
SE1 1YD

Thank you for your letter following the inquest into the death of Sandra Higham. In
your report you state that Ms Higham died from cerebral ischaemia as the result of an
atrial-oesophageal fistula which developed following an ablation procedure for atrial
fibrillation. You note that the evidence you heard shows that a fistula of this nature is a

very rare, but known, risk of the ablation procedure.

I was sorry to read of Ms Higham’s death and wish to extend my sincere sympathies
to her family.

You raise the following concerns:

The ablation procedure for atrial fibrillation is becoming more widespread (an
increase of around 20-30% has been seen in recent years).

The development of an atrial-oesophageal fistula is a very rare, but known, risk
of the ablation procedure (developing in around 0.01-0.2% of cases of
percutaneous ablation and around 1-1.5% of cases of surgical ablation).

If an atrial-oesophageal fistula does develop, it has a very high mortality rate
(reported to be 67-100%).

According to the literature there are no clear predictors of mortality from an
atrial-oesophageal fistula, but early diagnosis, prompt surgical intervention and
prolonged antibiotic therapy may be crucial for survival.

Diagnosing an atrial-oesophageal fistula can be difficult, especially in an acute
medical setting, given its range of non-specific symptoms and duration of onset,
and the lack of awareness within the wider medical profession of such a fistula
being a risk of the ablation procedure.

My officials initially contacted the Royal College of Surgeons (RCS) about this case
and were advised to consult the Society for Cardiothoracic Surgery (SCTS) and the
British Cardiovascular Society (BCS), as your concern relates to a specific type of
procedure.

The SCTS confirmed that atrial-oesophageal fistula is a very rare complication of a
cardiology procedure, which may present to upper gastrointestinal surgeons and, less
often, thoracic surgeons.

The SCTS suggested that both cardiologists and electro-physiologists, through the
BCS, were best placed to respond to your concerns and suggested that BCS could
prepare a letter to be circulated to the upper gastrointestinal surgeons, thoracic
surgeons and cardiac surgeons.

My officials have contacted the BCS about this suggestion and I understand that BCS
are considering this proposal. Consideration includes the merits of circulating a letter
to relevant surgeons, as the SCTS suggested.

A copy of your letter and our response will be sent to the BCS. I trust they will take
the opportunity to respond to you directly about this issue.

You may of course wish to consider writing to the BCS, as the appropriate specialty
organisation, yourself with your concerns. A copy of your letter and our response will
also be sent to the RCS for their information.

I hope that this response is helpful and I am grateful to you for bringing the
circumstances of Ms Higham’s death to my attention.

DRDAN POULTER

€

Public Health
England —

Protecting and improving the nation’s health Public Accountability Unit T +44 (0)20 7654 8000
Public Health England
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133-155 Wellington House
SE1 8UG

Clerk to HM Coroner
Southwark Coroner's Court
1 Tennis Street

SE17YD

22 December 2014
Our Ref: 141106122

RE: Prevent Future Deaths report touching the death of Mrs Sarah Higham

Thank you for your letter of 6 November to Duncan Selbie regarding the circumstances of
_Mrs Higham’s death. | have been asked to reply on Mr Selbie’s behalf.

While | was sorry to read.of Mrs Higham’s death, this case is not something that Public
Health England can directly assist with. However, | understand that you have written to the
Department of Health, who will contact appropriate bodies on your behaif, such as the British
Cardiology Society. The Department will be in touch with you in due course to inform you of
the actions to be taken.

| am sorry that | am unable to be of direct assistance on this occasion.
Yours sincerely,

Correspondence and Public Enquiries Officer

Public Health England