Editor's Choice – Percutaneous Access Does Not Confer Superior Clinical Outcomes Over Cutdown Access for Endovascular Aneurysm Repair: Meta-Analysis and Trial Sequential Analysis of Randomised Controlled Trials

Abstract

WHAT THIS PAPER ADDSA meta-analysis was conducted of the most up to date, randomised clinical trial data of percutaneous vs. cutdown endovascular aneurysm repair (EVAR). The risk of bias was assessed with the updated Cochrane methodology, and the evidence was appraised with the GRADE system (Grades of Recommendation, Assessment, Development and Evaluation). Percutaneous EVAR was not found to have superior clinical outcomes to cutdown EVAR. The studies were judged to be high risk of bias or have some concerns, and the level of evidence was graded as low or very low for all investigated outcomes. The study highlights the need for high quality evidence on the potential advantages of percutaneous over cutdown EVAR.Objective: To investigate whether a percutaneous approach has better clinical outcomes than surgical access for standard endovascular repair of abdominal aortic aneurysms. Data sources: MEDLINE and Embase were searched using the Healthcare Databases Advanced Search interface developed by the National Institute for Health and Care Excellence. Review methods: Randomised controlled trials (RCTs) that compared percutaneous and cutdown endovascular aneurysm repair (EVAR) were considered. Pooled effect estimates were calculated using the odds ratio (OR), risk difference, or mean difference (MD) and 95% confidence interval (CI). The ManteleHaenszel or inverse variance statistical method was used as appropriate. Trial sequential analysis was performed to quantify the available evidence and control for the risk of type 1 and type 2 error. Risk of bias was assessed with the revised tool developed by Cochrane and the quality of evidence was graded using the GRADE system (Grades of Recommendation, Assessment, Development and Evaluation). Results: Four RCTs were identified, reporting a total of 368 patients and 530 access sites. Meta-analysis showed no difference in access site complications or infection, post-operative bleeding/haematoma, access related arterial injury, femoral artery occlusion, pseudo-aneurysm, or peri-operative mortality between percutaneous and cutdown EVAR. Seroma/lymphorrhoea was significantly less frequent after percutaneous EVAR (0%) compared with cutdown EVAR (3%; OR 0.18 [95% CI 0.04e0.83]) and the procedure time was significantly shorter (MD e11.53 minutes; 95% CI e15.71e7.34), but hospital length of stay was not different between treatments. Neither the O'BrieneFleming boundaries nor the futility boundaries were crossed by the cumulative Z curve, and the required information size was not reached for any of the outcomes. All trials were judged to be high risk of bias or have some concerns, and the level of the body of evidence was low or very low for all outcomes. Conclusion:The evidence is very uncertain about the effect of percutaneous EVAR on clinically important outcomes.

AAA Revisited: A Comprehensive Review of Risk Factors, Management, and Hallmarks of Pathogenesis

“…EVAR does not aim to replace the aneurysmal sac, but excludes it from systemic circulation by minimally invasive implantation of a stent graft [ 270 ]. The stent graft is delivered to the abdominal aorta through the femoral artery, either by a percutaneous approach or by a surgical cut-down [ 271 ]. After confirmation of the exact vessel measurements by digital subtraction angiography, the delivery system is inserted over a stiff guidewire and then deployed and ballooned to expand and attach the stent graft to the aortic wall.…”

“…The various types of endoleaks are the most common complication of EVAR and often require reintervention [ 277 ]. Other complications of EVAR include problems related to the access site, especially when the iliac arteries are small, calcified or severely tortuous [ 271 ], and a systemic inflammatory response termed ‘post-implantation syndrome’ in the early postoperative phase [ 278 ]. Complex endovascular aortic repair should only be advised at tertiary university hospitals, due to the necessary case numbers for experience in both complex EVAR and OSR, in case of complication management [ 273 , 274 ].…”

Negative Pressure Wound Therapy for the Prevention of Surgical Site Infections Using Fascia Closure After EVAR—A Randomized Trial

“…Stent migration (%) 0 (0.0) 0 (0.0) 2 (13.3) systematic reviews with meta-analyses of RCTs only, no significant difference in SSI incidence was seen [19,20]. In one of the reviews [20], a significant decrease in seroma/lymphorrhea incidence with PCD was demonstrated.…”

The effect of percutaneouS vs. cutdoWn accEss in patients after Endovascular aorTic repair (SWEET): Study protocol for a single-blind, single-center, randomized controlled trial

“…As no previous studies reported PCOs, we used the incidence of access site complications to estimate the sample size of the SWEET trial. According to previous studies, the incidence of access site complications in percutaneous EVAR was 7.64%, compared with 11.81% in cutdown EVAR (13). We estimated the number of patients needed in this non-inferiority trial with noninferiority margin of 0.10 (bilateral α 5%, power 80%) by PASS 15.0 software, and 54 patients are required for percutaneous and cutdown EVAR group, respectively.…”

“…In addition, no RCTs have been published comparing two types of access in TEVAR. Though the recent meta-analysis revealed comparable access complication rates between two access procedures, it is noteworthy that no studies reported patient-centered outcomes (PCOs), for instance, patient's experience and quality of life after surgery (13). Considering its relatively small impact on prognosis and large impact on quality of life, PCOs may be a new perspective to shed light on the selection of access procedures in EVAR or TEVAR.…”