Inquest into the death of Toni Ann PEADON

Contributing factors

• lead became embedded in superior vena cava wall
• laser sheath cut through vessel wall rather than just adhesions
• anatomical embedding of lead was undetectable on fluoroscopy imaging
• procedure performed in cardiac catheterisation laboratory rather than hybrid operating theatre
• cardiothoracic team not present in procedure room
• cardiothoracic team notification protocols were not followed prior to procedure
• significant delay in patient transfer to operating theatre (approximately 20 minutes from cardiac arrest)
• pericardial tamponade preventing cardiac output despite resuscitation attempts

Coroner's recommendations

1. The department of cardiology at Westmead Hospital, in consultation with the NSW Ministry of Health and the Cardiac Society of Australia and New Zealand, should consider introducing a specific form of written consent for lead extraction procedures which includes: (1) pertinent elements of the planned procedure and all reasonable alternatives; (2) the percentage risk of major and minor complications; (3) a statement that lead extractions can be potentially life-threatening, including Westmead Hospital's rates and outcomes; (4) a statement of the proceduralist's personal level of experience in lead extractions and outcomes; and (5) the emergency procedures in place should a complication arise.
2. Patient consent should be obtained in the presence of a family member or friend, insofar as is reasonably practicable.
3. The Cardiac Society of Australia and New Zealand should consider clarifying its policy statement on lead extraction to: (1) distinguish between cases that should be dealt with in a cardiac catheterisation laboratory and those in an operating theatre, or require that all lead extractions be conducted in operating theatres unless a hybrid theatre is available; (2) if lead extractions are performed in catheterisation laboratories, specify exactly what surgical support should be available before the procedure commences; and (3) clarify the meaning of 'immediately available' in relation to surgical backup.
4. Hospitals undertaking lead extraction procedures should ensure that emergency management protocols are clearly established and followed, including: (1) pre-procedure notification of cardiothoracic team; (2) operating theatre on standby; (3) appropriate anaesthetic monitoring including arterial line; (4) transoesophageal echocardiography; (5) blood products immediately available; (6) equipment for emergency sternotomy and cardiopulmonary bypass readily accessible; and (7) cardiothoracic surgical team present or immediately available.
5. Consideration should be given to construction of a hybrid operating theatre combining the facilities of a cardiac catheterisation laboratory with a cardiac operating theatre to allow for rapid access to emergency open heart surgery if complications arise during lead extraction procedures.