Sandra Higham

Dear Ms Hill REPORT ON DEVELOPMENT OF ATRIO-OESOPHAGEAL FISTULA FOLLOWING ABLATION FOR ATRIAL FIBRILLATION Ablation as therapeutic 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 fiom 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 procedure. Other complications, such a8 pulmonary vein stenosis 0" Dressler'$ syndrome will also have 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 significant difference to the occurrence of this complication Operators should be aware that 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. Cappato R, Calkins H, Chen SA, et al, Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circ Arrhythm Electrophysiol 2010; 3: 32-8. option the delay they

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. need to be told in this situation to (a) go to their local emergency department immediately and (b) 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 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 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. BHRS will work with the AF Association and A-A to re-design the information relating to complications of AF ablation to include information 0n 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.

From Dr Dan Poulter MP Parliamentary Under Secretary of State for Health Department Richmond House 79 Whitehall of Health London POCS 898876 SWIA 2NS Tel: 020 7210 4850 Ms H Hill Assistant Coroner Southwark Coroner' s Court 1 Tennis Street 7 MAR 2015 Southwark SEI 1YD OeJ (s Hu; 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: Iwas 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 a risk of the ablation procedure. being

My officials initially contacted the Royal 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 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. 1 that this response is helpful and I am grateful to you for bringing the circumstances of Ms Higham's death to my attention. O ns 1 DR DAN POULTER College they - hope