Endoaortic balloon occlusion for cardiac surgery

# Guidance
Current evidence on the safety and efficacy of endoaortic balloon occlusion for cardiac surgery is adequate to support the use of this procedure provided that normal arrangements are in place for consent, audit and clinical governance.
The procedure should only be carried out by a highly experienced team and with the use of continuous transoesophageal echocardiography.# The procedure

# Indications and current treatments
Endoaortic balloon occlusion is performed to achieve temporary obstruction of the aorta during cardiac surgery, including mitral valve repair or replacement and coronary artery bypass grafting.
Occlusion of the aorta is required in a number of cardiac operations. This is normally achieved by external application of an aortic cross-clamp, either during conventional open surgery or during minimally invasive cardiac procedures.

# Outline of the procedure
This procedure is usually employed during minimally invasive cardiac operations (also known as port-access surgery) that require endovascular aortic occlusion, cardioplegia and left ventricular decompression.
A balloon catheter is inserted through the skin into an artery (normally the femoral artery in the groin) and manipulated towards the aortic root. The balloon at the tip of the catheter is filled with saline to occlude the aorta and prevent blood flow. Various devices can be used for this procedure.
Continuous transoesophageal echocardiographic monitoring is used to detect balloon migration along with other forms of monitoring such as radial arterial pressure monitoring and direct monitoring of the surgical field, as necessary.
Sections 2.3 and 2.4 describe efficacy and safety outcomes which were available in the published literature and which the Committee considered as part of the evidence about this procedure. For more details, refer to the Sources of evidence.

# Efficacy
There were no outcomes reported in the literature that related directly to the efficacy of endoaortic balloon occlusion alone.
The Specialist Advisers considered key efficacy outcomes to include efficiency of cardioprotection, reduced length of hospital stay, duration of cardiac arrest and avoidance of the use of a cross-clamp from outside.

# Safety
In a case series of 306 patients treated with endoaortic balloon occlusion, the 30-day mortality rate was 1% (3/306) and the rate of late deaths (mean follow-up 20 months) was 2% (6/306). A case series comparing 117 patients treated with endoaortic balloon occlusion with 117 matched controls treated with conventional aortic cross-clamping reported one perioperative death in each group. In four case series, 5% (11/209), 4% (6/151), 1% (1/127) and 25% (13/52) of patients who were treated with endoaortic balloon occlusion died in hospital.
The three case series of 306, 209 and 117 patients treated with endoaortic balloon occlusion all reported aortic dissection in 1% (3/306, 3/209, and 1/117) of patients. One aortic dissection in the case series of 151 patients was judged by the authors to be unrelated to the endoaortic balloon occlusion device. In the case series that described 58, 120 and 127 patients, no aortic dissections occurred.
In a case series of 449 patients, there were no significant differences in the incidences of arrhythmias, pulmonary dysfunction, bleeding, renal failure or low cardiac output between those treated with endoaortic balloon occlusion and those treated with transthoracic clamping. However, the rates of neurological complications were higher in patients who had endoaortic balloon occlusion (p < 0.05; absolute numbers not given). (Neurological complications were defined as stroke and transient hemiplegia.)
In five case series, stroke or transient ischaemic attack was reported in 4% (2/52), 2% (2/127), 0.4% (1/306), 1% (1/117) and 1% (1/151) of patients.
In seven case series, re-exploration for bleeding or tamponade was required in 10% (6/60), 9% (26/306), 7% (14/209), 6% (9/151), 4% (5/117), 4% (1/23) and 2% (3/127) of patients treated with endoaortic balloon occlusion.
In the case series of 306 and 151 patients, myocardial infarction was reported in 1 and 2 patients, respectively.
The Specialist Advisers reported anecdotal adverse events including aortic dissection, balloon puncture, balloon migration, damage to aortic intima, device movement causing loss of occlusion, femoral artery damage, difficulty positioning the balloon, death due to failure to deliver cardioplegia, and inability to complete planned surgery due to occlusion failure. Additional theoretical adverse events noted by the Advisers were stroke, inadequate myocardial protection and cerebral ischaemia due to balloon misplacement and arterial embolism. The Advisers noted that this procedure has the potential to reduce stroke risk in patients who have a very calcified aorta.

# Other comments
The Committee noted that there have been technical modifications to and evolution in the design of the endoaortic balloons with the intention of improving their performance; and that newer designs may be associated with lower complication rates.# Further information

# Sources of evidence
The evidence considered by the Interventional Procedures Advisory Committee is described in the overview.

# Information for patients
NICE has produced information on this procedure for patients and carers ('Understanding NICE guidance'). It explains the nature of the procedure and the guidance issued by NICE, and has been written with patient consent in mind.# About this guidance
NICE interventional procedure guidance makes recommendations on the safety and efficacy of the procedure. It does not cover whether or not the NHS should fund a procedure. Funding decisions are taken by local NHS bodies after considering the clinical effectiveness of the procedure and whether it represents value for money for the NHS. It is for healthcare professionals and people using the NHS in England, Wales, Scotland and Northern Ireland, and is endorsed by Healthcare Improvement Scotland for implementation by NHSScotland.
This guidance was developed using the NICE interventional procedure guidance process.
We have produced a summary of this guidance for patients and carers. Information about the evidence it is based on is also available.
Changes since publication
January 2012: minor maintenance.
Your responsibility
This guidance represents the views of NICE and was arrived at after careful consideration of the available evidence. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of healthcare professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way which would be inconsistent with compliance with those duties.
Copyright
 National Institute for Health and Clinical Excellence 2008. All rights reserved. NICE copyright material can be downloaded for private research and study, and may be reproduced for educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the written permission of NICE.
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