Key messages
– We found insufficient high-quality evidence about whether skin puncture or exposing the femoral artery is better for minimally invasive repairs of abdominal aortic aneurysms.
– Skin puncture may make little to no difference to short-term mortality. There is probably little or no difference in failure to seal the aneurysms, wound infection, major complications within 30 days or while in hospital, medium- to long-term (six months) complications and bleeding complications between the two groups. Compared with exposing the femoral artery, skin puncture may reduce the operating time slightly.
– More, larger, well-designed studies are needed to give better estimates of the benefits and potential harms of two different access methods for minimally invasive repairs of abdominal aortic aneurysms.
What is an abdominal aortic aneurysm?
An abdominal aortic aneurysm is a ballooning of the largest blood vessel in the abdomen, the abdominal aorta, due to weakness of the vessel wall. This ballooning may lead to life-threatening rupture. Repair of the aneurysm is recommended if the risk of rupture is greater than the risk of surgery.
How is an abdominal aortic aneurysm treated?
Most repairs involve putting in an artificial graft, a tube composed of fabric, to help strengthen the artery wall. There are two main methods for repair. One is an open technique in which the whole abdomen is opened and the graft is used to replace the diseased part of the vessel. The other technique is endovascular aneurysm repair. With this minimally invasive technique, the graft is fed into the abdominal aorta through an artery in the groin (the femoral artery) avoiding the large abdominal incision. This review looked at an alternative method for introducing the graft into the femoral artery, percutaneous access. Instead of making an incision in the groin to expose the femoral artery (a cut-down), a needle is inserted into the femoral artery and a flexible guide wire is inserted through the needle. The needle is removed and a plastic tube is introduced into the femoral artery over the guide wire (percutaneous access), with a small cut in the skin to allow the passage of the plastic tube. Once introduced, the guide wire can be removed leaving the tube in place in the artery. The artificial graft and all other materials can then be fed into the artery via the plastic tube. Once the procedure is complete the tube can be withdrawn. The surface incision can usually be closed with a single stitch.
What did we want to find out?
We wanted to know if skin puncture was better than exposing the femoral artery for minimally invasive repairs of abdominal aortic aneurysms.
What did we do?
We searched for studies that included people with abdominal aortic aneurysms who were treated with minimally invasive repairs. These studies randomly selected participants to receive the minimally invasive repairs by skin puncture or exposing the femoral artery. We compared and summarised their results and rated our confidence in the evidence, based on factors such as study methods and sizes.
What did we find?
We found three studies involving 318 people with abdominal aortic aneurysms who were treated with minimally invasive repairs by skin puncture or exposing the femoral artery. We have little confidence that there is no difference in short-term mortality and are moderately confident that there is no difference in failure to seal the aneurysms, wound infection, major complications within 30 days or while in hospital, medium- to long-term (six months) complications and bleeding complications. We have little confidence that skin puncture reduces the operating time slightly.
What are the limitations of the evidence?
We have moderate to little confidence in the evidence because the results were imprecise due to the small number of participants and low event rate, and the studies used different types of devices for delivering artificial grafts.
How up to date is this evidence?
This review updates a previous Cochrane Review. The evidence is up to date to April 2022.
Skin puncture may make little to no difference to short-term mortality. There is probably little or no difference in failure of aneurysm exclusion (failure to seal the aneurysms), wound infection, major complications within 30 days or while in hospital, medium- to long-term (six months) complications and bleeding complications between the two groups. Compared with exposing the femoral artery, skin puncture may reduce the operating time slightly. We downgraded the certainty of the evidence to moderate and low as a result of imprecision due to the small number of participants, low event rates and wide CIs, and inconsistency due to clinical heterogeneity. As the number of included studies was limited, further research into this technique would be beneficial.
Abdominal aortic aneurysms (AAAs) are a vascular condition with significant risk attached, particularly if they rupture. Therefore, it is critical to identify and repair these as an elective procedure before they rupture and require emergency surgery. Repair has traditionally been an open surgical technique that required a large incision across the abdomen. Endovascular abdominal aortic aneurysm repairs (EVARs) are now a common alternative. In this procedure, the common femoral artery is exposed via a cut-down approach and a graft is introduced to the aneurysm in this way. This Cochrane Review examines a totally percutaneous approach to EVAR. This technique gives a minimally invasive approach to femoral artery access that may reduce groin wound complication rates and improve recovery time. However, the technique may be less applicable in people with, for example, groin scarring or arterial calcification. This is an update of the previous Cochrane Review published in 2017.
To evaluate the benefits and harms of totally percutaneous access compared to cut-down femoral artery access in people undergoing elective bifurcated abdominal endovascular aneurysm repair (EVAR).
We used standard, extensive Cochrane search methods The latest search was 8 April 2022.
We included randomised controlled trials in people diagnosed with an AAA comparing totally percutaneous versus surgical cut-down access endovascular repair. We considered all device types. We only considered studies investigating elective repairs. We excluded studies reporting emergency surgery for ruptured AAAs and those reporting aorto-uni-iliac repairs.
We used standard Cochrane methods. Our primary outcomes were 1. short-term mortality, 2. failure of aneurysm exclusion and 3. wound infection. Secondary outcomes were 4. major complications (30-day or in-hospital); 5. medium- to long-term (6 and 12 months) complications and mortality; 6. bleeding complications and haematoma; and 7. operating time, duration of intensive treatment unit (ITU) stay and hospital stay. We used GRADE to assess the certainty of evidence for the seven most clinically relevant primary and secondary outcomes.
Three studies with 318 participants met the inclusion criteria, 189 undergoing the percutaneous technique and 129 treated by cut-down femoral artery access. One study had a small sample size and did not adequately report the method of randomisation, allocation concealment or preselected outcomes. The other two larger studies had few sources of bias and good methodology; although one study had a high risk of bias in selective reporting.
We observed no clear difference in short-term mortality between groups, with only one death occurring overall, in the totally percutaneous group (risk ratio (RR) 1.50, 95% confidence interval (CI) 0.06 to 36.18; 2 studies, 181 participants; low-certainty evidence). One study reported failure of aneurysm exclusion. There was one failure of aneurysm exclusion in the surgical cut-down femoral artery access group (RR 0.17, 95% CI 0.01 to 4.02; 1 study, 151 participants; moderate-certainty evidence). For wound infection, there was no clear difference between groups (RR 0.18, 95% CI 0.01 to 3.59; 3 studies, 318 participants; moderate-certainty evidence).
There was no clear difference between percutaneous and cut-down femoral artery access groups in major complications (RR 1.21, 95% CI 0.61 to 2.41; 3 studies, 318 participants; moderate-certainty evidence), bleeding complications (RR 1.02, 95% CI 0.29 to 3.64; 2 studies, 181 participants; moderate-certainty evidence) or haematoma (RR 0.88, 95% CI 0.13 to 6.05; 2 studies, 288 participants).
One study reported medium- to long-term complications at six months, with no clear differences between the percutaneous and cut-down femoral artery access groups (RR 0.82, 95% CI 0.25 to 2.65; 1 study, 135 participants; moderate-certainty evidence).
We detected differences in operating time, with the percutaneous approach being faster than cut-down femoral artery access (mean difference (MD) −21.13 minutes, 95% CI −41.74 to −0.53 minutes; 3 studies, 318 participants; low-certainty evidence). One study reported the duration of ITU stay and hospital stay, with no clear difference between groups.