The National Institute for Health and Clinical Excellence (NICE) in the UK has released an interventional procedures programme for laparoscopic repair of abdominal aortic aneurysm (AAA).
This overview has been prepared to assist members of the Interventional Procedures Advisory Committee (IPAC) in making recommendations about the safety and efficacy of an interventional procedure. It is based on a rapid review of the medical literature and specialist opinion.
Entitled, ‘Laparoscopic repair of abdominal aortic aneurysm’, the document was prepared in January 2007 in collaboration with Mr Jonothan Earnshaw, Mr D Nott (Vascular Society), and representatives from the Association of Laparoscopic Surgeons of Great Britain and Ireland, Miss Cathy McGuiness and Mr R Vohra. All four advisors were unanimous in their opinions on the current status of the procedure, that it is novel and with uncertain safety and efficacy profile.
Specialist Advisors considered the key efficacy outcomes of 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, return to theatre, and 30-day survival.
The majority of the outcomes reported in the studies included in the overview concern the characteristics of the procedure and the immediate recovery period. No evidence from randomised controlled trials is available.
The medical literature was searched to identify studies and reviews relevant to laparoscopic repair of abdominal aortic aneurysm. Searches were conducted via the following databases, covering the period from their commencement to 19-12-2006: Medline, PreMedline, EMBASE, Cochrane Library and other databases. Trial registries and the Internet were also searched. No language restriction was applied to the searches.
The list of studies included in the overview is based on four non-randomised controlled studies, and two cases. There were no published reviews with meta-analysis or evidence based guidelines identified at the time of the literature search.
Operative time
In three non-randomised controlled trials which compared laparoscopic aneurysm repair with open surgery, the mean operative time was longer in the laparoscopic groups (181 minutes using HALS1, 468 minutes2, and 7.7 hours3) than in the patients undergoing open surgery (136 minutes1, 301minutes2, and 5.0 hours3 respectively). Statistical significance levels were not stated in any of these three studies. A fourth non-randomised controlled study comparing laparoscopic aneurysm repair (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)4.
In one case series the mean operative time was 257 minutes (for HALS)5 and in a second case series operative time was 265 minutes for a totally laparoscopic aneurysm repair procedure, and 175 minutes with HALS6.
Length of stay
Conversely to operative time, hospital length of stay (LOS) was lower following laparoscopic aneurysm repair than open surgery. In three non-randomised controlled trials LOS was 5.9 days (HALS)1, 6.2 days2, and 6.3 days3, following laparoscopic aneurysm repair, whereas it was 9.4 days1, 10.0 days2, and 10.2 days3 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)4.
In one case series LOS was five days among 131 patients treated with totally laparoscopic aneurysm repair and seven days in 215 patients with HALS6. In a second case series overall LOS following HALS was reported as 4.4 days. However, subgroup analysis showed 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)5.
Safety
The important safety outcomes by which to evaluate this procedure were highlighted by Specialist Advisors to be death within 30 days and late mortality, and major complications such as blood loss, infection, multiple organ failure, and leg ischaemia/limb loss.
The rate of postoperative death following laparoscopic aneurysm repair has been reported at between, 3% (1/29) (HALS)1, 4% (1/24) (HALS)4, 5% (3/60)3, and 10% (2/20)2.
One non-randomised controlled trial reported that the rate of respiratory insufficiency was 3% (2/60) following laparoscopic aneurysm repair compared to 7% (7/100) following open repair, the rate of renal insufficiency was also lower, 2% (1/60) and 11% (11/100) respectively3. The rate of infection following laparoscopic aneurysm repair has been reported between 2% (1/60)3 (one case leading to multiple organ failure and death) and 5% (1/20)2.
Other complications reported following laparoscopic aneurysm repair include bleeding at between <1% (1/122) (HALS)5 and 2% (1/60)3, myocardial infarction 2% (1/60)3, and pneumonia at between 0% (HALS)1, 2% (2/131)6 and (3/122) (HALS)5, and 4% (1/24) (HALS)4.
Specialist advisors’ opinions
The Specialist Advisors said that the proposed benefit of the procedure is to effect a complete repair of the aorta avoiding the need for open surgery and reducing the length of hospital stay. The adverse events known to advisors or reported in the literature include death, bowel perforation, bleeding, vascular embolisation, long ischemia times and the need to convert to open surgery.
One advisor suggested that if the repair can be completed successfully, it is assumed to be as safe as an open repair. All advisors agreed that there is a steep learning curve with this operation, and practitioners require advanced laparoscopic training and expertise in vascular surgery. In addition, appropriate hardware must be available.
However, the advisors were divided in their opinions as to the likely impact of this procedure on the NHS, with two suggesting that it is likely to be used in fewer than ten specialist centres, one that it would probably be used in a minority of hospitals but at least ten, and one was unable to predict the likely spread at the present time.
All in all, lack of training in laparoscopic vascular surgery is a potential limitation to the development of this procedure, the advisors stated.
References
1. Kolvenbach R. (2001) Hand-assisted laparoscopic abdominal aortic aneurysm repair. Semin Laparosc.Surg 8: 168-177.
2. Edoga JK, Asgarian K, Singh D et al. (1998) Laparoscopic surgery for abdominal aortic aneurysms. Technical elements of the procedure and a preliminary report of the first 22 patients. Surg Endosc 12: 1064-1072.
3. Castronuovo JJ, Jr., James KV, Resnikoff M et al. (2000) Laparoscopic-assisted abdominal aortic aneurysmectomy. J Vasc.Surg 32: 224-233.
4. Kolvenbach R, Ceshire N, Pinter L et al. (2001) Laparoscopy-assisted aneurysm resection as a minimal invasive alternative in patients unsuitable for endovascular surgery. J Vasc.Surg 34: 216-221.
5. Ferrari M, Adami D, Corso AD et al. (2006) Laparoscopy-assisted abdominal aortic aneurysm repair: Early and middle-term results of a consecutive series of 122 cases. Journal of Vascular Surgery 43: 695-700.
6. Kolvenbach R, Puerschel A, Fajer S et al. (2006) Total Laparoscopic Aortic Surgery versus Minimal Access Techniques: Review of More than 600 patients. Vascular 14 (4): 186-192.
