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NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE
Interventional Procedure Consultation Document
Totally endoscopic robotically assisted coronary artery bypass grafting
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The National Institute for Clinical Excellence is examining totally endoscopic robotically assisted coronary artery bypass grafting and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. 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 totally endoscopic robotically assisted coronary artery bypass grafting. This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:
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:
For further details, see the Interventional Procedures Programme manual, which is available from the Institute's website (www.nice.org.uk/ipprogrammemanual). Closing date for comments: 22 March 2005 Target date for publication of guidance: June 2005 |
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Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation. |
| 1 | Provisional recommendations |
| 1.1 |
Current evidence on the safety and efficacy of totally endoscopic robotically assisted coronary artery bypass grafting does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research. |
| 1.2 |
Clinicians wishing to undertake totally endoscopic robotically assisted coronary artery bypass grafting should take the following actions.
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| 1.3 | Publication of safety and efficacy outcomes will be useful. The Institute may review the procedure upon publication of further evidence. |
| 2 | The procedure |
| 2.1 | Indications |
| 2.1.1 |
In coronary artery disease, plaque deposits on the inner walls and lining of the coronary arteries lead to a hardening and narrowing of the arteries and subsequently decreased oxygen supply to the heart. This may cause angina or myocardial infarction, and long-term weakening of the heart muscle leading to heart failure or arrhythmia. |
| 2.1.2 |
The aim of a coronary artery bypass graft (CABG) is to increase the flow of blood to the heart by inserting grafts to bypass the obstructed coronary vessel(s). |
| 2.1.3 |
CABG is usually performed by open surgery through a sternotomy. Catheter-based interventions for myocardial revascularisation have been developed that produce less surgical trauma, avoid the need for general anaesthesia and shorten recovery time. These include minimally invasive direct coronary artery bypass. |
| 2.2 | Outline of the procedure |
| 2.2.1 |
Totally endoscopic coronary artery bypass (TECAB) systems may vary depending on the equipment used, but they generally include a surgeon's viewing and control console with display system. Remote-control surgical equipment handles control robotic arms that position and precisely manoeuvre endoscopic instruments and an endoscope within the patient. Some equipment uses voice-controlled robotic arms. |
| 2.2.2 | Following deflation of the lung, small port incisions are made in three intercostal spaces through which one robotic arm carrying the endoscope and two arms with surgical implement attachments are introduced. Grafts are harvested from suitable donor sites, and are used to bypass one or more diseased coronary arteries. |
| 2.2.3 | TECAB treatment of the beating heart is carried out using a stabilisation device consisting of two branches that immobilise the site for anastomosis while the heart continues to beat. This removes the need for cardiopulmonary bypass. The stabilisation device is introduced into the chest through an additional port incision. |
| 2.3 | Efficacy |
| 2.3.1 |
Fully patent grafts were achieved in 95% (21/22) of patients when assessed at 3 months by postoperative angiography and good functional results. |
| 2.3.2 | Most case series used duration of operation as a measure and this varied according to type of procedure undertaken and the number of vessels bypassed. In 45 consecutive patients undergoing TECAB, the mean operating time was 4 hours 12 minutes for single vessel surgery and 6 hours 18 minutes for multiple vessel surgery. In 35 patients including 8 in whom the procedure was performed on the beating heart, the operating time ranged from 3 hours 30 minutes to 8 hours (mean 5 hours 47 minutes). In a further 37 patients (29 of whom had the beating heart procedure), the mean operating time for the early cases in the series was 4 hours 40 minutes, but this was reduced to 3 hours 6 minutes following the introduction of endoscopic stabilisation. The mean length of stay in an intensive care unit varied from 14 hours to 74 hours, and the mean total length of hospital stay ranged from 5.0 to 15.4 days. The upper limits for length of stay were following multiple vessel surgery. For more details, refer to the sources of evidence (see Appendix). |
| 2.3.3 |
The Specialist Advisors noted that bleeding could potentially make vessel identification difficult. They also noted that coronary patency is yet to be established. |
| 2.4 | Safety |
| 2.4.1 |
Conversion rates to open procedures (either mini-thoracotomy or full sternotomy) were reported in all case series and ranged from 18.5% (5/27) to 51% (19/37) of procedures initiated as TECAB. |
| 2.4.2 |
There were no cases of operative mortality associated with the TECAB procedure. |
| 2.4.3 | In a case series of 45 patients, operative complications included port access failure in 7% (3/45 patients), prolonged cross clamp time in 9% (4/45 patients), myocardial infarction in 2% (1/45 patients), hypoxic brain damage in 2% (1/45 patients), and internal thoracic artery injury in 2% (1/45 patients). |
| 2.4.4 | In a series of 45 patients, 4% (2/45) needed secondary investigation because of bleeding from the site of anastomosis. There were no cases of wound infection at the port site throughout the series. For more details, refer to the sources of evidence (see Appendix). |
| 2.4.5 | The Specialist Advisors noted theoretical complications as myocardial infarction, pneumothorax, cardiac tamponade, and fatal haemorrhage. They also noted that there is potential for stenosis or occlusion at the site of anastomosis. |
| 2.5 | Other Comments |
| 2.5.1 |
There are a number of other procedures for treating patients with coronary artery disease but no good studies have been found that compare these with TECAB |
Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
March 2005
| Appendix: | Sources of evidence |
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The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations. Interventional procedure overview of totally endoscopic robotically assisted coronary artery bypass grafting, November 2004 Available from: www.nice.org.uk/ip202overview
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