The National Institute for Clinical Excellence is examining off-pump coronary artery bypass and will publish guidance on its safety and efficacy to the NHS in England and Wales. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about off-pump coronary artery bypass.

This document has been prepared for public consultation. It summarises the procedure and sets out the provisional recommendations made by the Advisory Committee.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute will follow after the consultation period ends is as follows.

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare the Final Interventional Procedure Document (FIPD) and submit it to the Institute.
• The FIPD may be used as the basis for the Institute's guidance on the use of the procedure in the NHS in England and Wales.

For further details, see the Interim Guide to the Interventional Procedures Programme, which is available from the Institute's website (www.nice.org.uk/ip).

Closing date for comments: 28 October 2003

Target date for publication of guidance: April 2004

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.

Current evidence on the safety and efficacy of off-pump coronary artery bypass (OPCAB) appears adequate to support the use of this procedure, provided that normal arrangements are in place for consent, audit and clinical governance.

This recommendation applies to the procedure when performed through a median sternotomy only.

OPCAB is used to treat single or multiple vessel coronary artery disease.

The main alternative to OPCAB is coronary artery bypass grafting (CABG) with cardiopulmonary bypass (CPB). Coronary heart disease can also be treated with medical therapy, but if this is inadequate, endovascular treatments such as percutaneous transluminal coronary angioplasty (PTCA) with or without stenting, or CABG may be used.

The heart is displaced and snares are placed around the target coronary artery(ies) that need to be bypassed. With the aid of local immobilisation the artery is bypassed with the heart beating. Although OPCAB was used first for easily accessible single vessel disease, it is increasingly being used in elderly patients with multiple vessel disease and in patients with significant co-morbidity.

Evidence was reviewed on the efficacy of OPCAB compared with on-pump CABG. A systematic review from 2001 reported that there were no statistically significant differences detected in terms of efficacy outcomes, although there was a trend towards a shorter operative time and length of stay in hospital in OPCAB. In a report of 401 patients undergoing CABG, 33 (17%) of 200 patients in the OPCAB group died or had a cardiac-related event, compared with 42 (21%) of 201 in the on-pump group. For more details refer to the Overview (see Appendix).

The Specialist Advisors considered that OPCAB was at least as good as conventional surgery. One Specialist Advisor reported that OPCAB has been investigated extensively and is regarded as an accepted procedure, with established safety and efficacy.

The studies suggested fewer instances of arterial fibrillation and less blood loss in OPCAB compared with CABG. In a pooled analysis of two randomised controlled trials patients treated with OPCAB had a reduced risk of atrial fibrillation (25%) and chest infection (12%) compared with patients treated with on-pump CABG. For more details refer to the Overview (see Appendix).

The Specialist Advisors did not have major concerns about the safety of this procedure. They considered it to be as safe as on-pump surgery.

The Advisory Committee noted that the training necessary to perform OPCAB is different from that needed for on-pump surgery.

Although it appears that the results 1 year after OPCAB are similar to those after on-pump surgery, further data are needed before definitive conclusions on long-term outcomes can be drawn.

The evidence considered by the Interventional Procedures Advisory Committee is described in the following document.

• Interventional Procedure Overview of Off-Pump Coronary Artery Bypass, November 2002

Available from: www.nice.org.uk/ip035overview