Abstract
Keywords
Introduction
Since the introduction of endovascular aortic repair (EVAR) in the 1980s, there have been substantial changes in the treatment of abdominal aortic aneurysms (AAAs). 1 With improved delivery technique and better technical features of the next-generation stent-grafts, EVAR shows lower intraoperative mortality and morbidity compared with the conventional open operation for AAA.2–4
After 20 years, there is still no consensus about which type of anesthesia is most suitable for EVAR. Feasibility of local and regional anesthesia was proven in 1999. 5 According to the guidelines of the European Society for Vascular Surgery, the preferential use of local anesthesia for EVAR is feasible and appears to be well tolerated, restricting regional or general anesthesia only to those with predefined contraindications for local anesthesia. 6 The Society for Vascular Surgery practice guidelines suggest the use of epidural and local anesthetic along with conscious sedation for patients undergoing EVAR. 7 However, these guidelines are based on a low level of evidence and recommendation.
The main objective of this study was to compare different anesthesia techniques in a real-world setting based on data retrieved from the prospective Endurant Stent Graft Natural Selection Global Post-Market Registry (ENGAGE) database.
Methods
Registry Design
The prospective, multicenter, nonrandomized ENGAGE Registry was undertaken to quantify the performance of the Endurant Stent Graft System (Medtronic, Santa Rosa, CA, USA) within the context of contemporary, real-world use. Ruptured AAAs were not eligible for the Registry, which was conducted according to the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. The Institutional Review Board at all participating sites approved the protocol, data collection, and analysis; informed consent for authorization of data release was obtained in all patients at the time of enrollment. Preexisting medical comorbidities and cardiovascular risk factors were recorded along with procedure and device information on web-based case report forms. Full methodological details of the ENGAGE Registry 8 and of data collection 9 were described previously. All of the data were reviewed, and more than 40% of patients’ source documentation was monitored randomly. 8
Quality of life was assessed using the EuroQoL 5-Dimensions Questionnaire (EQ-5D) index score, a standardized instrument for use as a measure of health outcome in 3 different ways. 10 The descriptive system has 5 dimensions (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression) and 3 levels (no problems, some problems, extreme problems), which create 243 unique health states and can be converted into a single summary EQ-5D index (second measure) by applying scores from a set of general population preference weights. This study used the Dutch value set to calculate the EQ-5D index. The third measure was a 0 to 100 visual analogue scale (VAS) for self-rating of patient health. Ratings took place at the first contact (baseline), at discharge, and at the 30-day outpatient visit.
Definitions and Outcome Variables
Data about type of anesthesia were derived from operation and anesthesia reports. Local anesthesia (LA) was defined as infiltration of local anesthetics into the groin in combination or not with sedation. Spinal and epidural anesthesia were both defined as regional anesthesia (RA). If multiple anesthesia techniques were used, patients were assigned to the most invasive technique.
The primary outcome measure for the current analysis was 30-day morbidity and mortality. Secondary outcome measures included adverse events and quality of life. Technical success, procedure time, fluoroscopic time, volume of contrast, postoperative stay, and intensive care unit (ICU) admission were recorded. Initial technical success was defined as successful delivery and deployment of the Endurant endograft, without unintentional coverage of renal arteries, internal iliac arteries, or visceral branches, with absence of either a type I or III endoleak, followed by successful removal of the delivery system. 11 Duration of the implant procedure was defined as the time between cutdown or puncture and removal of the last guide catheter. Thirty-day complications included all-cause mortality, cardiac complications (cardiac death, myocardial infarction, cardiogenic shock, arrhythmia, other) bowel ischemia, neurologic complications (paraplegia, stroke), renal failure, respiratory failure, and surgical complications (access site, blood loss >1000 mL, conversion to open surgery). Thirty-day follow-up was completed for all patients.
Patient Groups
Excluding 2 patients who had missing anesthesia type, data were collected on 1261 patients (mean age 73.1 years; 1130 men) enrolled in the ENGAGE registry. Of these, 145 (11.5%) had LA, 331 (26.2%) had RA, and 785 (62.3%) had general anesthesia (GA). The GA group included 6 patients who scored both spinal and general anesthesia. Demographic data and baseline risk factors are presented in Table 1.
Baseline Characteristics According to Anesthesia Type.
Abbreviations: ASA, American Society of Anesthesiologists; CAD, coronary artery disease; CHF, congestive heart failure; MI, myocardial infarction.
Continuous data are presented as the means ± standard deviation; categorical data are given as the counts/sample (percentage).
Statistical Analysis
Categorical variables are presented as frequencies (percentages); continuous variables are presented as mean ± standard deviation and/or median and interquartile range in the event of skewed data. Differences in baseline characteristics among the 3 study groups were analyzed using the chi-square test for discrete variables and the analysis of variance or the Kruskal-Wallis test for continuous variables. Multivariate logistic and linear regression analyses were used to adjust for possible confounding factors; multicollinearity was checked using the variance inflation factor and the tolerance. While p<0.05 was considered statistically significant for most analyses, the value was adjusted to p<0.017 for the regression analysis (Bonferroni correction) owing to multiple testing between groups. All statistical analyses were performed using SPSS software (version 20 for MAC; IBM Corporation, Somers, NY, USA)
Results
Baseline Characteristics
Patients were predominantly men, and the distribution of sexes was comparable between the groups. On average, there was an overall significant difference in age in GA, RA, and LA patients (Table 1, p=0.026). Distribution among the American Society of Anesthesiologists (ASA) classes was not equal (p=0.002); ASA class IV was associated with predominant use of GA (Figure 1). Symptomatic presentation was lower in LA and RA patients compared with GA patients (p=0.004). Risk factors, such as tobacco use, hyperlipidemia, coronary artery disease, and cardiac revascularization, were overall significantly different among groups (Table 1). Baseline aneurysm characteristics are summarized in Table 2. There were no significant differences in AAA diameter (p=0.449). Distal iliac fixation site diameters, proximal normal neck length, and angulation were significantly different among groups.

Distribution of anesthesia type by American Society of Anesthesiologists (ASA) classification. GA, general anesthesia; LA, local anesthesia; RA, regional anesthesia.
Baseline Aneurysm Characteristics.
Abbreviation: AAA, abdominal aortic aneurysm.
Data are presented as the means ± standard deviation.
Intraoperative Outcomes
The mean adjusted procedure duration (Table 3) was significantly shorter in LA (80.4±40.0 minutes) compared to RA (94.2±41.6 minutes, adjusted p=0.001) and GA (105.3±46.0 minutes, adjusted p<0.001). There were no significant differences in type I and/or type III endoleaks at completion angiography among groups. Type of anesthesia used did not influence technical success rates. No intraoperative deaths occurred.
Procedure Data by Anesthesia Type.
Abbreviations: CI, confidence interval; GA, general anesthesia; ICU, intensive care unit; LA, local anesthesia; OR, odds ratio; RA, regional anesthesia.
Continuous data are presented as the means ± standard deviation; categorical data are given as the counts/sample (percentage).
Adjusted for age, baseline symptoms, ASA classification, tobacco use, hyperlipidemia, coronary artery disease, cardiac revascularization.
Level of significance for multiple testing: p<0.017.
Focusing on hospitalization, GA patients were significantly longer in the hospital than RA and LA patients (adjusted p=0.003 and p=0.010, respectively). GA and LA patients were admitted more frequently to the ICU than RA patients (GA vs RA: adjusted OR 1.40, 95% CI 1.03 to 1.90, p=0.030; RA vs LA: adjusted OR 0.51, 95% CI 0.33 to 0.79, p=0.002).
Mortality and Morbidity
Within 30 days after implant (Table 4), 11 (1.4%) GA patients died vs 3 (0.9%) RA patients (adjusted OR 1.52, 95% CI 0.41 to 5.65, p=0.534) vs 2 (1.4%) LA patients (adjusted OR 0.91, 95% CI 0.19 to 4.36, p=0.904). There were no significant differences for systemic or surgical complications.
Outcomes at 30 Days by Anesthesia Type.
Abbreviations: GA, general anesthesia; LA, local anesthesia; RA, regional anesthesia.
Continuous data are presented as the means ± standard deviation; categorical data are given as the counts (percentage).
Odds ratio (95% confidence interval) adjusted for age, baseline symptoms, ASA classification, tobacco use, hyperlipidemia, coronary artery disease, cardiac revascularization.
Activities of Daily Living and Quality of Life
Table 5 displays differences in quality of life data for the groups at each of the 3 time points (intergroup differences) and within each group from baseline to discharge and 30 days (intragroup differences). At baseline, quality of life and the dimensions of health status were similar in the 3 groups. At discharge, the LA group scored significantly better on usual activities and self-care. The change in EQ-5D index from baseline to discharge was negative in GA and RA patients (−0.06±0.22 and −0.03±0.17, respectively); no change was found in LA patients (0.00±0.19, p=0.006). After 30 days, there was an overall significant difference in VAS score among study groups (p=0.021) favoring LA patients. Changes in EQ-5D index from baseline to 30 days were positive for all groups and overall not significantly different (p=0.328).
Outcome of Activities of Daily Living and Quality of Life at 3 Time Points by Anesthesia Type.
Abbreviation: EQ-5D, EuroQoL 5-Dimensions Questionnaire; VAS, visual analogue scale.
Continuous data are presented as the means ± standard deviation and median (interquartile range); categorical data are given as the counts (percentage).
A Dutch value set used to calculate EQ-5D index score.
Discussion
The effect of different anesthetic techniques in EVAR is described in small studies with possible selection bias. Unprecedented in size, scope, and geographic representation, the ENGAGE Registry represents the collective experience of 79 centers in 30 countries across 5 continents using a single stent-graft. Patients with a wide spectrum of comorbidities were included, resulting in a representation of everyday real-world clinical practice. 8
According to the European and American guidelines, the use of local anesthesia for EVAR is preferred.6,7 Despite this consensus, EVAR is still mainly conducted under GA,12–15 as reflected in our study in which more than half the patients were treated under GA. However, there were large intercontinental differences for the primary choice of anesthetic (Figure 2). The differences between regions in Europe were even more remarkable. This could be explained by sustained regional customs of vascular surgeons and anesthesiologists. Another interesting finding is that patients in the GA group had a significantly higher ASA score, which is not according to the European guidelines. 6 Unfortunately, the Registry did not foresee the need for a specific explanation on the individual choice of anesthesia, so we can only speculate on individual preferences.

Distribution of anesthesia type by geographic region. GA, general anesthesia; RA, regional anesthesia; LA, local anesthesia.
In a cohort of 217 consecutive patients treated with a “local anesthesia–first strategy,” LA could be applied in ~75% of patients undergoing elective EVAR. 16 Lachat et al 17 published their first results of 100 consecutive patients treated percutaneously under local anesthesia in an outpatient setting, showing excellent results. Compared to the older EUROpean collaborators on Stent-graft Techniques for abdominal Aneurysm Repair (EUROSTAR) registry data, 14 our analysis found a more frequent use of LA (11.5% vs 5.6%), which implies that LA is applied more commonly today.
EUROSTAR data indicated no differences in surgical outcome among types of anesthesia. 14 Our results are consistent with these findings, showing comparable rates of technical success and endoleaks among the groups. In addition, no significant differences were seen in the need for secondary procedures within 30 days after implant.
LA and RA had shorter procedure times and hospital stays than GA.12,14,18,19 In contrast to previous reports,13,14,18–21 the LA group had a remarkably higher requirement for ICU admission. This difference might be caused by 2 centers that had 100% ICU admission in 38 (26.2%) LA patients. When these groups were excluded, a significantly lower ICU admission rate emerged for LA (22.4%) compared with GA (35.8%; adjusted OR 0.55, 95% CI 0.33 to 0.91, p=0.020).
LA and RA are proven to be feasible and safe as an alternative for general anesthesia during EVAR. 22 All-cause mortality rates were low in all 3 groups and were comparable with other studies.14,15 There were no differences in short-term complications. There was a suggestion that LA might have fewer complications, but no significant advantage for LA was established, probably due to the low incidence of complications and its infrequent use. LA scored best on EQ-5D compared to RA and GA, which may imply that patients recover quicker after LA.
Bakker et al 23 described a significantly higher cardiac event rate at 30 days comparing general and locoregional anesthesia (OR 3.8, 95% CI 1.1 to 12.9, p=0.03). Despite a larger group of patients, there was no significant difference in cardiac event rates between general and locoregional anesthesia (OR 1.09, 95% CI 0.45 to 2.67, p=0.849) in the ENGAGE cohort.
The success of EVAR is highly dependent on AAA anatomy. Short and angulated infrarenal aortic necks increase the risk of type I endoleaks. 24 Complex AAA anatomy may also extend the duration of surgery, resulting in more discomfort for patients treated with locoregional anesthesia. 25 There was a shorter infrarenal neck length and a smaller iliac access diameter in the LA group. However, these differences were minimal and did not result in relevant differences in AAA complexity. LA may influence imaging quality because it is very dependent on patient movement and breath-holding ability during imaging. 16 This could be an explanation why we found significantly more contrast use in the LA group.
General anesthesia might be preferred for extremely complex cases when there is a possibility of immediate conversion to open surgery. However, there was a low conversion rate of 0.3% in our study population. Furthermore, with an appropriate standby anesthetic team, conversion to GA is always possible.
Limitations
Unfortunately, preoperative clarification regarding the choice of anesthesia type is missing. Information regarding possible anesthesia type conversion was not documented. Therefore, no intention-to-treat analysis could be performed, and selection bias may have affected the results. The technique of femoral/iliac access was not documented. Percutaneous EVAR influences the amount of blood loss, operating time, and postoperative stay, possibly confounding results. Also, one has to take into account that the ENGAGE Registry was not designed nor powered for this specific retrospective analysis, restraining our findings.
Conclusion
The main findings of this study were that LA and RA had advantages compared with GA regarding duration of procedure and postoperative stay. No effects of anesthesia type on procedure success and perioperative mortality and morbidity were reported. Patients seemed to recover quicker after LA. Based on these results, a strategy based on preferential use of locoregional anesthesia for EVAR is advised, restricting GA only to those with predefined contraindications.
Footnotes
Declaration of Conflicting Interests
The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Joep A. W. Teijink, Philippe W. M. Cuypers, and Marc R. H. M. van Sambeek have received contributions and research grants from Medtronic AVE. Joep Teijink and Philippe Cuypers have been proctors for Medtronic AVE.
Funding
The author(s) report receiving the following financial support for the research, authorship, and/or publication of this article: Medtronic AVE funded the ENGAGE Registry. The Department of Vascular Surgery of the Catharina Hospital funded the writing of this article and was given access to the ENGAGE database to answer the study questions in this article.
