BEST EVIDENCE TOPIC – VASCULAR

Interactive CardioVascular and Thoracic Surgery 18 (2014) 814–820 doi:10.1093/icvts/ivu031 Advance Access publication 26 February 2014

How does elective laparoscopic abdominal aortic aneurysm repair compare to endovascular aneurysm repair? Nadeem Ahmeda, Nicholas D. Gollopb,*, Jonathan Ellisc and Omar A. Khand a b c d

Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK The Norfolk and Norwich University Hospital, Norwich, UK The Queen Elizabeth Hospital, Norfolk, UK Department of Upper GI Surgery, St Georges Hospital, London, UK

* Corresponding author. The Norfolk and Norwich University Hospital, Colney Lane, Norwich, NR4 7UY Norfolk, UK. Tel: +44-1603-286286; fax: +44-1603-286420038; e-mail: [email protected] (N.D. Gollop). Received 26 October 2013; received in revised form 16 January 2014; accepted 4 February 2014

Abstract A best evidence topic in surgery was written according to a structured protocol. The question addressed was how elective laparoscopic abdominal aortic aneurysm (AAA) repair compared to endovascular aneurysm repair (EVAR) in terms of survival. There were 229 papers found using the reported search, with 8 papers (5 prospective studies, 1 retrospective study, 1 randomized trial and 1 systematic review) representing the best evidence to answer the question proposed. Current evidence suggests that EVAR is the preferred surgical approach for AAA repair, due to shorter hospital stay and lower perioperative morbidity and mortality rates, as opposed to an open surgical approach. Despite this, EVAR is subject to a number of limitations, including device restrictions in patients with anatomical variations as well as increased risk of future complications stemming from device implantation. We discuss a key study that showed that complications in the EVAR group commonly included endoleak type II and graft thrombosis. More importantly, there were similar rates of complications between those patients receiving EVAR and those receiving minimally invasive aortic surgery. The evidence suggests that elective laparoscopic AAA repair has a favourable safety profile comparable with that of EVAR, with low conversion rates as well as similar mortality and morbidity rates. This has been illustrated in several studies. We discuss a prospective randomized trial of 100 patients, which compared EVAR with hand-assisted laparoscopic surgery. This study showed no deaths in either group after the procedure or at follow-up after 12 months, with similar complication rates between the groups. While the evidence suggests that EVAR is less invasive, it does not always significantly alter the postoperative course or length of hospital stay for patients. We conclude from the evidence available that elective laparoscopic AAA repair may have a role in those patients who are unsuitable for EVAR. Unfortunately, few studies exist directly comparing these two techniques, and those that do are subject to limitations, for example, study population bias, small sample sizes and a lack of comparison in the literature between the common AAA repair techniques. Keywords: Laparoscopic • Abdominal aortic aneurysm • Endovascular aneurysm repair • Minimally invasive aortic surgery • Hand-assisted laparoscopic surgery

INTRODUCTION A best evidence topic was constructed according to a structured protocol. This has been fully described in the ICVTS [1].

perform this procedure as an elective laparoscopic AAA repair, while another surgeon argues the case for EVAR. Intrigued by the most appropriate surgical approach, you consult the literature to determine which approach is superior in terms of survival, an elective laparoscopic AAA repair approach or EVAR.

Three-part question In those [ patients undergoing abdominal aortic aneurysm (AAA) repair], is [elective laparoscopic AAA repair] or [endovascular aneurysm repair (EVAR)] the best treatment in terms of [survival]?

Clinical scenario You are at a multidisciplinary team meeting discussing a patient with a potentially operable AAA. One of the surgeons offers to

Search strategy Medline search 1990–13 using the PubMed interface for the terms: (‘abdominal aortic aneurysm’ [MeSH Terms] OR (‘aortic’ [All Fields] AND ‘aneurysm’ [All Fields] AND ‘abdominal’ [All Fields]) AND (‘laparoscopy’ [MeSH Terms] OR ‘laparoscopy’ [All Fields] OR ‘laparoscopic’ [All Fields]) AND ‘endovascular’ [All Fields]. The search was current as of the 13 June 2013.

© The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Search outcome There were 229 papers found using the reported search. From these, eight papers were identified that provided the best evidence to answer the question. This includes five prospective studies, one retrospective study, one randomized trial and one systematic review, as presented in Table 1.

RESULTS Kolvenbach et al. [2] in a 2001 prospective cohort study (n = 40) demonstrated that hand-assisted laparoscopic surgery (HALS) could be offered to those patients who were deemed unsuitable for EVAR. A total of 24 patients received HALS and 13 patients received EVAR, with 3 excluded from the study [2]. HALS was achieved through transperitoneal access, which involved a midline mini-incision and the use of a HandPort to allow for aneurysm repair thereafter. There was 1 death in the HALS group vs 0 deaths in the EVAR group [2]. There were also four complications reported in each group, with a morbidity of 16.6% in HALS vs 30.7% in EVAR [2]. Those patients who received EVAR were transferred less frequently to intensive care unit (ICU) compared with HALS (P < 0.001) [2]. Surprisingly, there was no significant difference seen between the length of hospital stay and mobilization between the two groups. Tefera et al. [3] conducted a retrospective study (n = 84) comparing EVAR against minimal incision aortic surgery (MIAS) in patients who met high-risk criteria and had infrarenal aneurysms. A total of 84 patients were assessed, with 61 patients receiving EVAR and 23 patients receiving MIAS. Patients were assigned to a particular group on the basis of exclusionary criteria or patient choice if both options were available. Every procedure was performed with a bifurcated endograft system or standard Dacron prosthetic. In the EVAR group, there were 2 (3%) deaths (resulting from multiorgan failure) vs 1 (4%) death (resulting from an MI) in the MIAS group [3]. The 30-day morbidity was 11 (18%) patients in those receiving EVAR vs 4 (17%) patients receiving MIAS, with the average duration of stay being 5.1 days for both groups [3]. Unfortunately, there were no significant differences in morbidity and mortality between the two groups, with the P-value unspecified. Turnipseed et al. [4] performed a prospective cohort study comparing 70 EVAR patients against 96 MIAS patients. MIAS involved a small midline incision, followed by retraction of the small bowel using a Bookwalter retractor and open hand-sewn anastomoses. In the EVAR group, there were 2 (2.8%) deaths vs 2 (2.1%) deaths in the MIAS group [4]. In terms of morbidity, there were 14 cardiac, 5 embolic, 1 ileus, 9 pulmonary and 4 non-specified complications in the EVAR group vs 3 cardiac, 3 embolic, 2 ileus, 2 pulmonary and 8 non-specified complications in the MIAS group [4]. However, both mortality and morbidity rates did not differ significantly between the two groups, with P-values unspecified. The mean hospital stay for EVAR was 2 days vs 4.8 days for MIAS, which yet again did not reach significance [4]. Interestingly, the only statistical significance was in the cost of service delivery, which was −$7263 for EVAR and +$8445 for MIAS (P < 0.001) [4]. Veroux et al. [5] performed a prospective randomized trial of 100 patients, evaluating the incidence of sexual dysfunction between those patients treated by EVAR and HALS. HALS was

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achieved by a minilaparotomy incision with Omniport insertion. Conversely, EVAR involved endograft placement (Talent or Endurant) below the renal artery. There were 50 patients assigned to the EVAR group vs 50 patients in the HALS group. There were no reported deaths in either group during the procedure or at follow-up after 12 months [5]. In terms of morbidity, the EVAR group contained 4 cases of type 1 endoleak and 3 cases of type 2 endoleak [5]. Conversely, the HALS group had 2 patients develop laparosceles, which is defined as a herniation through the abdominal wall. The mean length of stay was 3.4 days for EVAR vs 4.2 days for HALS, though, again, this did not reach statistical significance [5]. Ferrari et al. [6] in 2006 conducted a consecutive case study, which reported the outcomes of 122 AAA repairs using HALS. HALS was achieved through a midline minilaparotomy incision allowing Omniport introduction and anastomosis formation between the aorta and Dacron prosthesis. Contraindications for HALS included peritonitis, bowel perforation, obstruction and distension, previous aortoiliac surgery, severe cardiovascular disease (including an ejection fraction of 3 mg/dl, recent myocardial infarction (MI), congestive heart failure (HF), percutaneous coronary angioplasty within 1 year, severe chronic obstructive pulmonary disease (COPD) and morbid obesity (BMI ≥ 40 kg/m2)

The outcomes of the two groups were compared Outcomes measured included patient demographics, morbidity, mortality and length of hospital stay

Mortality: in the EVAR group, there were 2 (3%) deaths (multiorgan failure) vs 1 (4%) death in the MIAS group (MI) (P-value was not significant) Morbidity at 30 days was 11 (18%) patients in the EVAR group vs 4 (17%) patients in the MIAS group (P-value was not significant) In the EVAR group, there were 3 cardiac, 1 pulmonary, 1 open conversion, 1 intraoperative rupture and 3 other complications vs 1 cardiac, 1 pulmonary, 1 distal embolization and 1 delirium tremens in the MIAS group

The findings suggested that MIAS is comparable with EVAR, particularly for those patients with high-risk aneurysms. MIAS is safe, maintains survival outcomes and has a postoperative recovery period similar to that of EVAR However, in this study, there was an unequal sample size between the two groups. Furthermore, its retrospective analysis may have been influenced by a selection bias. This may be demonstrated by the varying prevalence of comorbidities between the two groups

In the EVAR group, 6 patients (10%) required secondary interventions, 5 for endoleak and 1 for infection, vs no interventions in the MIAS group The mean operative time for was 250 min for EVAR vs 167 min for MIAS Average duration of stay was 5.1 days for both EVAR and MIAS (P-value was not significant)

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Table 1: (Continued) Author, date, journal and country Study type (level of evidence)

Patient group

Outcomes

Key results

Comments

Turnipseed et al. (2003), Am J Surg, USA [4]

Prospective non-randomized comparison study (n = 166) undergoing AAA repair

The outcomes of the two groups were compared

Mortality: 2 (2.1%) patients died in the MIAS group vs 2 (2.8%) patients died in the EVAR group. (P-value was not significant)

This study demonstrated that MIAS was a safe and cost-effective approach when compared with EVAR

Prospective cohort study (level 2)

Study period: 1999–2002 MIAS group (n = 96) vs EVAR group (n = 70)

Morbidity: in the MIAS group, 17 (18%) patients vs 19 (27%) patients in the EVAR group developed complications

Both EVAR and MIAS significantly reduced ICU and the length of hospital stay compared with an open surgical approach for AAA repair. However, only MIAS was shown to reduce hospital costs and enhance the net hospital margin, when compared with EVAR. There were limitations to this study, including a higher proportion of females in the MIAS group compared with EVAR as well as baseline differences in the presence of comorbidities between the two groups

Outcomes assessed included patient demographics, mortality, morbidity, operative time and length of hospital stay

In the MIAS group, this included, 3 cardiac, 3 embolisms, 2 ileus, 2 pulmonary and 8 other complications. In the EVAR group, there were 14 cardiac, 5 embolism, 1 ileus, 9 pulmonary and 4 other complications. The length of hospital stay for those patients in the MIAS group was 4.8 days vs 2.0 days for EVAR Intraoperative time was 154 min in MIAS vs 231 min in EVAR (P-value was not significant)

Net revenue was +$8445 for MIAS vs $7263 for EVAR (P < 0.0001) Veroux et al. (2010), Eur J Vasc Endovasc Surg, Italy [5] Randomized Prospective cohort study (level 2)

Single-centred, prospective randomized trial, with a 12-month follow-up period 100 patients were eligible for AAA repair and randomized to one of two groups: EVAR (n = 50) vs HALS (n = 50)

The outcomes of the two groups were assessed Outcomes measured included the incidence of sexual dysfunction, mortality, morbidity as well as length of hospital stay

Patients in the HALS group had a younger median age than those in the EVAR group at 61 vs 69 years, respectively (P = 0.002) Mortality: there were no deaths in either group during the procedure or at the 12-month follow-up

This study concluded that HALS could be a minimally invasive alternative for sexually active males who are unsuitable for EVAR. This study also demonstrates low mortality rates and comparable rates of morbidity between the two procedures

Morbidity: 3 (6%) patients in EVAR vs 2(4%) patients in the HALS group reported erectile dysfunction (P-value was not significant) There were also 2 patients in the HALS group developed laparoceles, one of whom needed surgical repair. In the EVAR group, 2 patients developed a graft thrombosis. There were also four type 1 endoleaks and three type 2 endoleaks that occurred in the EVAR group Respiratory complications were rare in both groups (HALS (0%) vs EVAR (1%)

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BEST EVIDENCE TOPIC

MIAS and EVAR had comparable lengths of stay in ICU, which were < 1 day

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Table 1: (Continued) Author, date, journal and country Study type (level of evidence)

Patient group

Outcomes

Key results

Comments

Leg ischaemia was higher in the EVAR group at 4 vs 2% in the HALS group (P = 0.04) Surgery duration was longer for HALS at 178 min vs 125 min for EVAR (P = 0.05) Length of hospital stay was 3.4 days in the EVAR group vs 4.2 days in the HALS group (P-value not significant) Ferrari et al. (2006), J Vasc Surg, Italy [6] Prospective study (level 2)

Prospective study in 604 consecutive cases of non-urgent AAAs

This study focused on those patients being treated by HALS

Study period: 2000–2004, with follow-up performed at 6 and 12 months and every year thereafter following surgery

Outcomes assessed included patient demographics, morbidity, mortality, operative times and length of hospital stay

122 (20.2%) cases were treated by HALS, 151 (25%) underwent EVAR and 331 (54.8%) underwent open surgery

Mortality: in the HALS group, there were no deaths Morbidity: there was a rate of 12.2%. Systemic complications included 3 (2.4%) pneumonia, 3 (2.4%) arrhythmia, 3 (2.4%) prolonged ileus, 2 (1.6%) myocardial ischaemia and 2 (1.6%) renal dysfunction There were 2 (1.6%) surgical complications included bleeding and thrombosis

This study concluded that HALS is both safe and feasible for AAA repair. This technique could also be considered as a bridge between open repair and TLS This study also noted that adverse factors such as obesity, large aneurysm size and need for suprarenal clamping did not influence the duration of procedure

There were 3 cases of incisional hernias and 1 bowel occlusion detected on the follow-up, which required laparoscopic treatment No conversion was needed during laparoscopy for 122 AAA patients, although 9 cases had an extended minilaparotomy The mean laparoscopic and total operative times were 64 min and 257 min, respectively The mean length of ICU stay was 14.3 h and mean length of hospital stay was 4.4 days A learning curve was associated with the procedure. When comparing the first 30 cases with the last 92, there was a significantly shorter endoscopic, cross-clamping and total operative time (P < 0.001) Javerliat et al. (2013), Ann Vasc Surg, France [7]

A prospective cohort study of 239 laparoscopic AAA repairs Study period: 2002–2010, with a follow-up of 42 months.

Outcomes assessed included morbidity, mortality and length of hospital stay

Mortality: no hospital mortality occurred, although there were 6 late deaths, which were reported as not being related to AAA

This study showed that laparoscopic AAA repair surgery is safe and long-lasting with favourable mortality and morbidity rates. This includes patients with standard surgical

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Table 1: (Continued) Author, date, journal and country Study type (level of evidence) Prospective cohort study (level 2)

Patient group

Outcomes

A subgroup of 99 patients with standard surgical risk and who had AAAs compatible with EVAR were identified

Key results

Comments

Morbidity: 3 patients with ‘severe’ complications, including 1 perioperative cardiac arrest, 1 febrile hypoxic atelectasis and 1 colonic ischaemia case

risk in cases when EVAR can be considered

There were 10 patients with ‘moderate’ complications, including 7 transitory elevations of creatinemia, 1 pneumonia, 1 prostatitis, 1 sigmoiditis and 1 cardiac arrhythmia case There were 4 patients with ‘local’ complications including 1 thrombosis, 1 compartment syndrome, 1 spleen rupture and 1 parietal haematoma case 5 (5%) patients required conversion to open surgery

Coggia et al. (2008), J Vasc Surg, France [8]

Prospective cohort study (n = 148) undergoing total laparoscopic AAA repairs

Prospective cohort study (level 3)

Study period: 2002–2007 A subset of 13 (8.8%) patients was identified and underwent laparoscopic juxtarenal AAA repair. This included 12 men and 1 woman

Outcomes assessed included morbidity, mortality, length of procedure and length of hospital stay

Mortality: No patients died during their procedure or at follow-up, with a median follow-up of 19 months Morbidity: 1 patient had a postoperative coagulopathy with haemorrhagic syndrome 5 patients (38.5%) had ‘moderate’ systemic complications, including 4 with renal insufficiencies without dialysis and 1 with ischaemic colitis

This study demonstrated that total laparoscopic juxtarenal AAA repair was feasible. The results show that no patients died after the procedure or at follow-up and a low complication rate However, limitations of this study included strict patient selection before TL juxtarenal AAA repair was considered and therefore it may not be truly applicable to the general population

1 (5.7%) patient presented with a ‘local’ complication limited to a superficial infection of a groin The median operative time was 260 min The median length of stay was 48 h in ICU and 10 days in hospital AAA: abdominal aortic aneurysm; HALS: hand-assisted laparoscopic surgery; EVAR: endovascular aneurysm repair; MIAS: minimally invasive aortic surgery; TLS: total laparoscopic surgery; ICU: intensive care unit.

BEST EVIDENCE TOPIC

The operative times and clamping times were 210 and 81 min, respectively

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Funding This work has received no funding from any sources. This review was endorsed by the UK Medical Student Association (UKMSA). Our research is supported by the UKMSA and British Heart Foundation (BHF). Conflict of interest: none declared.

REFERENCES [1] Dunning J, Prendergast B, Mackway-Jones K. Towards evidence-based medicine in cardiothoracic surgery: best BETS. Interact CardioVasc Thorac Surg 2003;2:405–9. [2] Kolvenbach R, Ceshire N, Pinter lL, Da Silva L, Deling O, Kasper AS. Laparoscopy-assisted aneurysm resection as a minimal invasive alternative in patients unsuitable for endovascular surgery. J Vasc Surg 2001;34: 216 e221.

[3] Tefera G, Carr SC, Turnipseed WD. Endovascular aortic repair or minimal incision aortic surgery: which procedure to choose for treatment of high-risk aortic aneurysms? Surgery 2004;136:4:748–753. [4] Turnipseed WD, Tefera G, Carr S. Comparison of minimal incision aortic surgery with endovascular aortic repair. Am J Surg 2003;186:287–91. [5] Veroux P, D’Arrigo G, Veroux M, Giaquinta A, Lomeo A. Sexual dysfunction after elective endovascular or hand-assisted laparoscopic abdominal aneurysm repair. Eur J Vasc Endovasc Surg 2010;40:71–5. [6] Xenos ES, Stevens SL, Freeman MB, Pacanowski JP, Cassada DC, Goldman MH. Erectile function after open or endovascular abdominal aortic aneurysm repair. Ann Vasc Surg 2003;17:530e8. [7] Ferrari M, Adami D, Del Corso A, Berchiolli R, Peitrabissa A, Romagnani F et al. Laparoscopy-assisted abdominal aortic aneurysm repair: early and middle-term results of a consecutive series of 122 cases. J Vasc Surg 2006; 43:695e700. [8] Javerliat I, Capdevila C, Beauchet A, Di Centa I, Goëau-Brissonnière O, Coggia M. Results of laparoscopic surgery for abdominal aortic aneurysm in patients with standard surgical risk and anatomic criteria compatible with EVAR. Ann Vasc Surg 2013;27:412–7. [9] Coggia M, Cerceau P, Centa ID, Javerliat I, Colacchio G, Goeau-Brissonniere O. Total laparoscopic juxtarenal abdominal aortic aneurysm repair. J Vasc Surg 2008;48:37–42.

How does elective laparoscopic abdominal aortic aneurysm repair compare to endovascular aneurysm repair?

A best evidence topic in surgery was written according to a structured protocol. The question addressed was how elective laparoscopic abdominal aortic...
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