Laparoscopic repair of abdominal aortic aneurysm (interventional procedures consultation)

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional Procedure Consultation Document

Laparoscopic repair of abdominal aortic aneurysm

An abdominal aortic aneurysm is a bulge in the section of the aorta that travels down through the abdomen. It occurs because of a weakness in the wall of the aorta. If the aneurysm bursts (ruptures), it causes internal bleeding, and this can be rapidly fatal. The damaged section of the aorta can be repaired preventatively with a synthetic tube stitched into the artery using video keyhole surgery.


The National Institute for Health and Clinical Excellence is examining laparoscopic repair of abdominal aortic aneurysm and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about laparoscopic repair of abdominal aortic aneurysm.

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:

  • comments on the preliminary recommendations
  • the identification of factual inaccuracies
  • additional relevant evidence.

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  • The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

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 May 2007
Target date for publication of guidance: August 2007


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

There is adequate evidence of the safety and efficacy of laparoscopic repair of abdominal aortic aneurysm, but the technical demands are such that this procedure should not be used without special arrangements for consent and for audit or research.

1.2

Clinicians wishing to undertake laparoscopic repair of abdominal aortic aneurysm should take the following actions.

  • Inform the clinical governance leads in their Trusts.
  • Ensure that patients understand the procedure and its place in the elective treatment of abdominal aortic aneurysms, and provide them with clear written information. In addition, the patient should be informed of other available techniques, and told that conversion to open surgery may be necessary. Use of the Institute’s information for patients (‘Understanding NICE guidance’) is recommended (available from www.nice.org.uk/IPG XXX publicinfo). [[details to be completed at publication]]
  • Audit and review clinical outcomes of all patients having laparoscopic repair of abdominal aortic aneurysm (see section 3.1).
1.3

Selection of patients should be performed by a multidisciplinary team experienced in the management of aortic aneurysms and able to offer alternative treatment options.

1.4 This procedure should be performed by vascular surgeons who have also had training in advanced laparoscopic surgery.

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2 The procedure
2.1 Indications
2.1.1

Dilatation of the aorta to form an aneurysm occurs in about 2% of men over the age of 65 (it is less common in women). Small aneurysms may present no problems, but some continue to grow, and larger aneurysms may leak or rupture. This carries a high risk of mortality, even when it is possible to offer emergency surgery. Preventative treatment is often advised for patients with aneurysms that represent an appreciable rupture risk.

2.1.2

The traditional treatment for abdominal aortic aneurysm is open surgical repair. The aneurysm is opened and a graft is then sewn in above and below the weakened area to allow normal blood flow. A less invasive approach is now commonly used, involving endovascular stent graft placement via the femoral arteries, but not all aneurysms are suitable for endovascular treatment.

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2.2 Outline of the procedure
2.2.1 Laparoscopic repair of abdominal aortic aneurysm can be done with assistance from the surgeon's hand or with instruments alone. For hand-assisted laparoscopic surgery (HALS), a midline minilaparotomy incision is made for insertion of one of the surgeon's hands, and in all cases small skin incisions are made for insertion of a laparoscope and instruments. Clamps are applied above and below the aneurysm and its sac is opened. Thrombus is removed and patent lumbar arteries are sutured from the inside of the aneurysm. A prosthetic vascular graft is anastomosed to the proximal and distal ends of the aorta. The aneurysm wall and the posterior parietal peritoneum are closed to cover the graft.

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2.3 Efficacy
2.3.1

In three non-randomised controlled trials that compared laparoscopic aneurysm repair with open surgery, the mean operative time was longer in the laparoscopic groups (181 minutes using HALS, 468 minutes and 7.7 hours) than in the open surgery groups (136 minutes, 301 minutes and 5.0 hours, respectively). Statistical significance levels were not stated in any of these three studies. A fourth non-randomised controlled study comparing HALS with endovascular stenting reported that operative time was again longer in the laparoscopic repair group (198 minutes and 149 minutes, respectively; not a statistically significant difference).

2.3.2

In one case series the mean operative time was 257 minutes (for HALS) and in a second case series operative time was 265 minutes for a totally laparoscopic aneurysm repair procedure, and 175 minutes for HALS.

2.3.3 Hospital length of stay (LOS) was shorter following laparoscopic aneurysm repair than after open surgery. In three non-randomised controlled trials LOS was 5.9 days (HALS), 6.2 days and 6.3 days following laparoscopic aneurysm repair, whereas it was 9.4 days, 10.0 days and 10.2 days, respectively, following open repair. One non-randomised controlled study reported that LOS was broadly similar following HALS (7.4 days) and endovascular stenting (6.4 days).
2.3.4 In one case series LOS was 5 days for 131 patients treated with laparoscopic aneurysm repair and 7 days for 215 patients treated with HALS. In a second case series overall LOS following HALS was reported as 4.4 days. Subgroup analysis indicated a statistically significant difference between the first 30 patients treated at one institution (5.3 days) and the last 92 patients treated (4.1 days) (p = 0.001). For more details, refer to the sources of evidence (see appendix).
2.3.5 All Specialist Advisers considered this procedure to be novel and of uncertain efficacy. They considered the key efficacy outcomes for this procedure to be successful complete repair, open conversion rates, operative time, intensive care unit and overall length of stay, patient quality of life criteria, renal function, need for return to theatre and 30-day survival. Some of the advisers suggested that there would be longer operating times, particularly early in the learning curve, and that it would be beneficial for vascular surgeons to have advanced laparoscopic training.

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2.4 Safety
2.4.1

Rates of postoperative death following laparoscopic aneurysm repair have been reported at 3% (1/29) (HALS), 4% (1/24) (HALS), 5% (3/60) and 10% (2/20) of patients.

2.4.2 One non-randomised controlled trial reported that the rate of renal insufficiency was 2% (1/60) following laparoscopic aneurysm repair compared with 11% (11/100) following open repair, and the rate of respiratory insufficiency was 3% (2/60) compared with 7% (7/100), respectively. The rate of infection following laparoscopic aneurysm repair has been reported at 2% (1/60) (one case leading to multiple organ failure and death) and 5%(1/20).
2.4.3 Other complications reported following laparoscopic aneurysm repair include bleeding in between <1% (1/122) (HALS) and 2% (1/60); myocardial infarction in 2% (1/60); and pneumonia in 0% (0/29) (HALS), 2% (3/122 [HALS] and 2/131) and 4% (1/24) (HALS). For more details, refer to the sources of evidence (see appendix).
2.4.4 Safety outcomes highlighted by the Specialist Advisers were death within 30 days and late mortality, and major complications such as blood loss, infection, multiple organ failure, and leg ischaemia/limb loss. They all agreed that the safety of this novel procedure is uncertain and that advanced training in laparoscopic surgical techniques is important.
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2.5 Other Comments
2.5.1

It was noted that there is more than one technique in use and that safety and efficacy may vary.

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3 Further information
3.1 This guidance requires that clinicians undertaking the procedure make special arrangements for audit. The Institute has identified relevant audit criteria and is developing an audit tool (which is for use at local discretion), which will be available when the guidance is published.
3.2 The Institute has issued guidance on stent-graft placement in abdominal aortic aneurysm (www.nice.org.uk/IPG163) and endovascular stent-graft placement in thoracic aortic aneurysms and dissections ( www.nice.org.uk/IPG127).

Barrie White
Vice Chairman, Interventional Procedures Advisory Committee
April 2007

Appendix: Sources of evidence

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

  • ' Interventional procedure overview of laparoscopic repair of abdominal aortic aneurysm', January 2007.
Available from: www.nice.org.uk/ip382overview.

This page was last updated: 30 March 2010