Mrs S was a 36-year-old patient diagnosed with a benign giant cell tumour of the sacrum. She was seen by Mr A, consultant in orthopaedic oncology, and listed for resection of the lesion. Prior to surgery Mrs S underwent preoperative tumour embolisation.
Mrs S was also reviewed by Mr B, consultant vascular surgeon, who planned to introduce an aortic balloon through the femoral artery prior to the tumour resection. If required, the aortic balloon could be inflated during the surgical resection in order to reduce blood loss. Mr B sought consent for aortic balloon occlusion and documented that the risks included “femoral artery injury, limb ischaemia and bleeding from rupture”. Separate consent was obtained by the orthopaedic team.
Surgery was initially performed in the supine position to allow access to the femoral vessels. The right common femoral artery was cannulated and a 6Fr sheath inserted. This was exchanged for a 14Fr sheath under radiological control. A 40mm aortic balloon was introduced to the level of L3, its position being confirmed on fluoroscopy.
Mrs S was then turned to the prone position to allow tumour resection. The balloon position was re-imaged and found to be unchanged. Mr B left the operating theatre.
After two hours, Mr B was called back to the theatre to inflate the aortic balloon as haemostasis was required. The balloon was inflated by Mr B using an inflation device. Haemostasis was improved and the blood pressure stable. No further imaging was performed at this stage. The inflation device was exchanged for a syringe with a threeway tap to facilitate deflation of the balloon by the orthopaedic team. Mr B then left the operating theatre.
After 30 minutes, the aortic balloon was deflated by the orthopaedic team. After ten minutes it was noted that it was not possible to maintain Mrs S’s blood pressure. After a further 20 minutes, the orthopaedic team re-inflated the aortic balloon in an effort to stabilise Mrs S in order to allow wound closure. There was a transient improvement in Mrs S’s blood pressure and after 40 minutes the orthopaedic procedure was complete.
Mr B received a telephone call to inform him the operation was finishing and he should return in order to remove the sheath and aortic balloon. Prior to him arriving at the operating theatre, the patient suffered a cardiac arrest and CPR was commenced.
Mrs S had an unrecordable blood pressure and at laparotomy a large retro-peritoneal haematoma was discovered secondary to a 2.5cm tear in the anterior aorta. The aorta was surgically repaired but after release of the clamps, Mrs S suffered a further cardiac arrest and died.
Mrs S’s family made a claim against Mr B. It was alleged that consent was inadequate as the risk of death was not specifically mentioned. It was also alleged that the aortic balloon used was inappropriate and that it was inappropriate to inflate the balloon without radiological guidance. In addition, it was alleged that delegation of the deflation of the balloon to the orthopaedic team was unacceptable.
Medical Protection sought an expert vascular surgery opinion from Professor T. Although the risk of vessel rupture and bleeding was discussed, he was critical of the failure to warn of the small risk of death from aortic balloon inflation.
Whilst acknowledging that re-inflating the aortic balloon without guidance may have been acceptable as a last-ditch effort to save the patient’s life under extreme circumstances, the decision to initially inflate the balloon without radiological guidance and to delegate deflation to the orthopaedic team was also criticised.
The case was settled for a high sum.
- Good communication and documentation are essential in the process of consent. Patients must be made aware of the risks of surgery and their implications.
- This should include common complications as well as any serious adverse outcomes, including rare complications, which may result in permanent disability or death.
- Patients need to be able to weigh up the benefits and risks of medical intervention so that they can make an informed decision as to whether they want to proceed.