Original Article
Anesthetic, Sedation, and Analgesic Technique for Successful Local Anesthetic EndoSuture Aneurysm Repair
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Vasc Specialist Int (2023) 39:3
Published online March 24, 2023 https://doi.org/10.5758/vsi.230003
Copyright © The Korean Society for Vascular Surgery.
Abstract
Materials and Methods: We included seven patients with abdominal aortic aneurysms who underwent endovascular aneurysm repair using EndoAnchors with a standard regimen consisting of local anesthesia, intravenous sedation, and analgesia. The procedural and follow-up details were retrospectively reviewed.
Results: Six out of seven infrarenal abdominal aortic aneurysms were successfully treated with endovascular aneurysm repair using primary EndoAnchors under local anesthesia. One patient was converted to general anesthesia due to acute aneurysm thrombosis independent of EndoAnchor deployment during the procedure. Remifentanyl infusions of up to 3.2 mg/min, morphine doses up to 6 mg (median, 0.5 mg), and midazolam doses of up to 4 mg (mean, 1.4 mg) were used. The mean theater time was 83 minutes (range, 60–130 minutes). Two patients were discharged on day 0, and the mean hospital stay was one day. All patients were alive between 484 and 1,128 days post-procedure, with no aneurysm-specific reintervention.
Conclusion: The combination of local anesthesia, intravenous sedation, and analgesia is a viable strategy for timely and effective endovascular aneurysm repair using EndoAnchors. This technique may allow endovascular repair of more ruptured aneurysms using EndoAnchors with potential survival benefits.
Keywords
INTRODUCTION
EndoAnchors (EAs; Medtronic Cardiovascular) have been available as an adjunctive option for endovascular aneurysm repair (EVAR) for over a decade, with a phase 1 feasibility trial of EA (then EndoStaples; Aptus Endosystems Inc.) published in 2009 [1]. When used appropriately, they are safe with low published rates of device-specific adverse events [2].
Follow-up periods of up to three years have been reported, demonstrating survival and freedom from aneurysm-related mortality comparable to conventional EVAR [3]. Current evidence comes mainly from case series, cohort studies, and registry data, and the surrogate endpoint of sac regression is widely used [4]. Significant proportion of the abdominal aortic aneurysms (AAAs) in these publications would be unsuitable for conventional EVAR; therefore, EVAR with EA (also known as EndoSuture aneurysm repair [ESAR]) can expand the indications for infrarenal EVAR [5].
With no evidence of long-term outcomes after ESAR, its role in elective endovascular management of AAA remains to be rigorously defined or proven. However, EVAR provides better outcomes than open surgical repair (OSR) in ruptured AAA (RAAA), with a potentially increased benefit if EVAR is performed under local anesthesia (LA) [6]. It has been postulated that ESAR might expand the indications of EVAR among patients with RAAA [7]. Therefore, it is essential to be able to achieve ESAR without general anesthesia (GA), as the ability to perform the procedure under LA is an advantage of EVAR over OSR.
Numerous studies have described ESAR under LA (LA-ESAR) but have not detailed the anesthetic regimen. We aimed to present our experience with elective LA-ESAR and demonstrate its viability.
MATERIALS AND METHODS
This study was retrospective and observational. Procedural data were collected from the Radiology Information System and Picture Archiving and Collection System. Patient data were collected from electronic patient records. Procedures performed between July 24, 2019, and April 28, 2021, were included. The inclusion criterion was LA-ESAR for any AAA. Patients with elective and emergency LA-ESAR were eligible for inclusion.
The UK National Research Ethics Service guidelines that define the methods used for service evaluation state that ethical approval is not required for service evaluation [8]. Ethics approval and need for informed consent was waived by the Institutional Review Board of Queen Elizabeth University Hospital.
Our primary outcome was technical success; secondary outcomes included procedural times, procedural and follow-up complications, sac size changes, and re-interventions.
Technical success was defined as deployment of the stent graft and EAs without GA. We defined two specific time measures: device time and theatre time. Device time was defined as the duration between the initial and final angiograms for the procedure. All devices (stent grafts and EAs) were deployed between these angiograms. Theatre time was defined as the duration between the patient entering and leaving the operating theatre. EA maldeployment was defined as <2 mm of aortic-wall penetration by an EA on follow-up computed tomography (CT). Percutaneous closure was performed in all cases using the suture-mediated closure device, Perclose ProGlide system (Abbott Vascular).
Data were analyzed using the R language and environment for statistical computing (R Foundation for Statistical Computing) in an RStudio integrated development environment [9,10]. The Shapiro–Wilk test was used to assess the normality of data distribution. No further statistical tests were deemed appropriate or necessary.
RESULTS
1) EVAR data of our center
During the 644 days (92 weeks) of data collection, 97 EVAR were performed. Of these, 77 were elective. Of these 77 procedures, 21 (27%), 2 (3%), and 54 (70%) were performed under LA, spinal anesthesia, and GA, respectively. Twelve of 77 patients underwent ESAR, of which seven (58%) were performed under LA. Among patients undergoing elective EVAR, bilateral percutaneous access, bilateral open surgical access, and percutaneous access in one side and surgical access in the other side was performed in 73 (95%), 3 (4%), and 1 (1%) patients, respectively. Of the five EVAR performed for rupture, three were performed under LA. No ESAR was performed in an emergency setting.
2) Patient demographics and aneurysm details
All seven patients who underwent LA-ESAR were male. All LA-ESAR procedures were elective. Patient ages ranged from 59 to 83 years and were normally distributed, with a mean of 71 years and standard deviation (SD) of 8 years. Five and two patients were classified as American Society of Anesthesiologists (ASA) class 3 and 4, respectively. The age of the five patients who underwent ESAR under GA (GA-ESAR) ranged from 62 to 77 years (mean, 72 years; SD, 6 years), and two, two, and one patients were classified as ASA class 2, 3, and 4, respectively.
3) Technical success and indications for EA
The technical success rate of LA-ESAR was 86% (6 out of 7 cases). One patient developed acute aneurysm thrombosis after deployment of the bifurcated device and was converted to GA due to ischemic lower limb pain. No further details of this case are presented in the Results section.
Regarding indications for EA, two aneurysms had conical necks, one had a wide and conical neck, one patient was very young with an incidental aneurysm discovery during surgical workup for bowel cancer, one relatively young patient had a short necked (<10 mm) aneurysm, and one patient had atherosclerotic disease in the aneurysm neck causing concern about seal (but not of sufficient thickness to contra-indicate EA).
4) Anesthesia, sedation, and analgesia regimen
All LA-ESAR procedures were performed percutaneously. We administered 10 mL of 1% lignocaine hydrochloride with 100 µg/20 mL adrenaline (Xylocaine; Aspen Pharma Trading Ltd.) mixed with 10 mL of levobupivacaine hydrochloride (Chirocaine, 50 mg/10 mL; AbbVie Ltd.) in each groin. We prioritized cutaneous and peri-arterial infiltration and used the full volume in each case. No patients required additional LA.
Intravenous analgesia was achieved using a combination of intravenous remifentanil (Wockhardt UK Ltd.) infusion and boluses of morphine sulfate (Torbay Pharmaceuticals) and midazolam hydrochloride (AAH Pharmaceuticals Ltd.). The baseline dose of remifentanil was calculated according to the patient’s weight and infusion rates ranged from 0.3-0.7 mg/min to 1-3.2 mg/min (from the lightest to heaviest patient). The morphine dose ranged from 0 to 6 mg and was abnormally distributed with a median of 0.5 mg and an interquartile range of 0-5 mg. Three patients did not receive morphine. The midazolam dose ranged from 0 to 4 mg and was normally distributed, with a mean of 1.4 mg (SD, 1.5 mg). Two patients did not receive midazolam. The medications administered to each patient are listed in Table 1.
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Table 1 . Analgesia and sedation received by each patient undergoing endosuture aneurysm repair under local anesthesia.
Patient Remifentanyl infusion rate (mg/min) Total morphine dose (mg) Total Midazolam dose (mg) Weight (kg) 1 1.5-1.6 6 1 60 2 1.2-1.7 5 2 83 3 1.0-3.2 0 0 94 4 1.8-2.0 1 4 88 5 0.5-1.0 0 1.5 85 6 0.3-0.7 0 0 99
All sedatives and analgesics were administered at the discretion of the anesthetist. Remifentanil infusion was started before access in all patients, except in one patient in whom it was started shortly thereafter. All four patients who received midazolam were administered a single dose at the start of the procedure. Three patients received regularly spaced extra doses during the procedure at the discretion of anesthetist. All three patients who received morphine were administered a bolus at the start of the procedure. Two of the three patients received additional doses of morphine: one patient received additional doses at the time of kissing balloon angioplasty at the aortic bifurcation and at the time of Proglide tightening at the end of the procedure, and another patient received an additional dose at the time of Proglide tightening at the end of the procedure. Five of the six patients received one or two doses of oral morphine (5 mg) after the procedure in the recovery room. All six patients received one or more doses of oral paracetamol/acetaminophen before discharge. No patient required additional sedative medication after the procedure. No patient was discharged on opiate analgesia.
5) Procedural details
Bifurcated stent grafts (Endurant II or IIs; Medtronic Cardiovascular) were used for all ESAR procedures. Unilateral internal iliac artery embolization was additionally performed in one patient. The number of EAs ranged from 6 to 9 and was abnormally distributed, with a median of 7 (interquartile range, 6-8). Among patients who underwent GA-ESAR, 6 and 10 EAs were deployed in four and one patients, respectively.
The Heli-FX guide (Medtronic Cardiovascular) catheter is a 16-Fr outer diameter device, and in all cases, it could be inserted via one of the sheaths already in situ for the EVAR.
Fluoroscopy time ranged from 12 to 39 minutes with a mean of 22 minutes (SD, 10 minutes). For GA-ESAR, the fluoroscopy time ranged from 24 to 38 minutes (mean, 31 minutes; SD, 6 minutes). The mean fluoroscopy time for elective EVAR (without EA) performed at our center during the same period was 22 minutes. About one-third of these elective EVAR involved an EVAR adjunct, the most common being unilateral internal iliac artery embolization.
Device time ranged from 26 to 71 minutes with a mean of 43 minutes (SD, 16 minutes). For GA-ESAR, device time ranged from 43 to 81 minutes (mean, 61 minutes; SD, 17 minutes). Theatre time ranged from 60 to 130 minutes with a mean of 83 minutes (SD, 27 minutes). For GA-ESAR, theatre time ranged from 115 to 170 minutes (mean, 142 minutes; SD, 24 minutes).
6) Procedural complications
One patient reported unilateral ischemic limb pain after deployment of all devices. After a brief discussion, agitation was managed with a dose of midazolam, and an angiogram was performed to confirm that there was no stent-graft thrombosis. The large caliber sheath was removed from the affected side. Angiography was repeated from the contralateral side to assess ESAR. At this time, the pain had resolved, and the patient’s leg was not clinically ischemic; therefore, infra-inguinal angiography was not performed.
One patient reported back pain on the left side during EA deployment on the left posterolateral side. The pain was self-limiting.
7) Outcomes
To facilitate early discharge, patients were mobilized within 2 hours of the procedure. Patients were discharged between 0 and 3 days after the procedure, with a mean of day 1 (SD, 1 day). Two patients were discharged on the day of the procedure. All patients remained alive at 484-1,128 days after the procedure. Patients who underwent GA-ESAR were discharged between 1 and 4 days after the procedure (mean, 2 days; SD, 1 day). All patients who underwent GA-ESAR remained alive at 486-981 days after the procedure.
On CT review, 40/43 (93%) EAs adequately penetrated through the aortic wall, with no patient having more than one inadequately penetrated EA. In patients who underwent GA-ESAR 30 of 34 (88%) EAs adequately penetrated through the aortic wall. No EA moved, embolized, or caused any clinical complications. Postoperative CT 12-17 months after ESAR showed an unchanged aneurysm sac size in one patient and >5 mm sac regression in five patients (Fig. 1). No endoleaks or other adverse outcomes were observed on CT.
-
Figure 1.Aneurysm sac size at baseline (pre-ESAR) and 12-17 months post-ESAR. Each patient is represented by a different symbol. Baseline and post-ESAR sac sizes are connected with a dashed line in case of sac size decrease >5 mm and a solid line otherwise. ESAR, EndoSuture aneurysm repair.
Regarding reintervention, one patient underwent common femoral artery endarterectomy and external iliac artery stenting for ischemic leg pain. This patient was different from the patient who had ischemic pain during LA-ESAR.
DISCUSSION
We presented our experience with LA-ESAR and described the anesthesia, sedation, and analgesia regimen used. In addition to describing the consistent LA regimen used, we documented that along with a remifentanyl infusion that varies according to both patient weight and requirement for analgesia, small doses of morphine and midazolam were required.
LA-ESAR has been reported in previous case series and in some outcomes published from the ANCHOR registry; however, none of these detailed the anesthesia, sedation, and analgesia regimen used [11-14].
In our series of seven patients, the technical success rate was 86%. This was due to a single case of aneurysm thrombosis that occurred during cannulation of the contralateral gate, and was therefore independent of EA deployment. This is the only case of intraprocedural aneurysm thrombosis that we encountered in the past several years at our institution, and its cause was not definitively determined. It has been included, as we chose to analyze technical success in an intention-to-treat manner. The procedure, including EA deployment, was completed after conversion to GA. The stent-graft thrombosis was managed endovascularly, and the patient was discharged on the second post-operative day [15]. No further complications were observed.
The procedure was well-tolerated by the remaining patients. Particularly, EA deployment caused pain in one patient during deployment of EA. Surprisingly, the pain was accurately localized to the site of EA deployment, but it was self-limiting.
Our rate of EA maldeployment was 7%, which compares favorably with both our EA maldeployment rate in GA-ESAR and with those of recent detailed analyses of inadequate aortic wall penetration, which reported rates ranging from 17% to 26% [16,17]. We believe that LA-ESAR can only be said to be successful if EAs are deployed appropriately for function.
Central to successful LA-ESAR is a time-efficient procedure, involving percutaneous access, closure, stent-graft deployment, and EA deployment. Our patients spent a mean of 83 min and a maximum of 130 minutes in the operating theatre, which compares favorably with a registry that reported a mean procedure time of 138 minutes [14]. Compared to GA-ESAR, the mean theatre time reduced by 59 minutes, allowing for increased patient throughput.
Given that EAs are deployed under fluoroscopy, we recorded fluoroscopy time for the entire procedure as a surrogate comparator and compared it to fluoroscopy time for elective infrarenal EVARs during the study period at our institution. The mean fluoroscopy time was 22 minutes for both groups. Two case series in which the majority of ESAR were performed under LA reported fluoroscopy times ranging from a mean of 12 minutes (for a mean of 5 EAs) to a median of 51 minutes (for a median of 9 EAs) [11,13].
A key limitation of our study is that while LA-ESAR is clearly viable, its indications remain unclear. This limitation is related to the major issue around EAs: what is their role in the endovascular management of infrarenal AAA? We believe that EA clearly expands the availability of EVAR to patients with RAAA. The UK National Institute for Health and Care Excellence (NICE) guidance on the management of AAA is generally skeptical of EVAR but recommends it over OSR for RAAA [6]. Within its evidence review is the non-randomized IMPROVE trial, which suggests that EVAR under LA for RAAA may have lower short-term mortality than EVAR under GA [18]. In a recent review of CT scans of 90 patients with RAAA, of the 46 patients who were unsuitable for conventional EVAR, 24 could have been treated with ESAR, an absolute increase of 27% [7]. Regardless of the long-term role of EAs, LA-ESAR could be applied to these patients with RAAA.
Our intention was to demonstrate that LA-ESAR is feasible in an emergency setting; however, we only presented patients who underwent elective procedures. In our institution, LA-ESAR for RAAA was not required till recently, when we applied it for a large symptomatic aneurysm in an unwell patient. The procedure followed the principles outlined herein and was successful with regard to all parameters.
A perceived issue with ESAR is increased radiation exposure compared to conventional EVAR due to the extra fluoroscopy required for EA deployment. Indeed, draft guidance from NICE suggests that EA deployment reportedly increases radiation exposure during the procedure [19]. While we have shown that fluoroscopy times for LA-ESAR can be as low as those for conventional EVAR, the C-arm angles used for EA deployment may mean that the fluoroscopy dose and total procedure dose are somewhat higher during ESAR. We did not record these data, but are unconvinced that the radiation dose increase would be detrimental to the patient.
The combined guidelines of the Society of Interventional Radiology and the Cardiovascular and Interventional Radiology Society of Europe are archaic, and neither society has published guidance on the use of EA in EVAR [20]. A more recent guideline from NICE states that complex EVAR (ESAR is considered complex EVAR in their definition) should not be offered to patients in whom OSR is suitable, except in the context of a clinical trial [6]. The same guideline suggests that EVAR may be better than OSR for RAAA (especially for males aged >70 years) and highlights the ability to perform EVAR under LA. In our opinion and local experience, using EA as an adjunct can be considered standard EVAR and can be offered with a simple LA, sedation, and analgesia regimen.
CONCLUSION
In summary, we described in detail the anesthesia, sedation, and analgesia regimen used to perform successful ESAR under LA. This regimen can be easily implemented through communication and collaboration among interventional radiologists, vascular surgeons, and anesthetists. Although the role of EA in elective EVAR is undefined, LA-ESAR may offer survival benefits to patients with RAAA whose only other option is OSR.
FUNDING
None.
CONFLICTS OF INTEREST
The authors have nothing to disclose.
AUTHOR CONTRIBUTIONS
Concept and design: all authors. Analysis and interpretation: MH. Data collection: MH. Writing the article: MH. Critical revision of the article: all authors. Final approval of the article: all authors. Overall responsibility: MH.
References
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- Mehta M, Henretta J, Glickman M, Deaton D, Naslund TC, Gray B, et al. Outcome of the pivotal study of the Aptus endovascular abdominal aortic aneurysms repair system. J Vasc Surg 2014;60:275-285.
- Muhs BE, Jordan W, Ouriel K, Rajaee S, de Vries JP. Matched cohort comparison of endovascular abdominal aortic aneurysm repair with and without EndoAnchors. J Vasc Surg 2018;67:1699-1707.
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- Reyes Valdivia A, Álvarez Marcos F, Duque Santos Á, Ocaña Guaita J, Gandarias Zúñiga C. Expanded suitability of ruptured abdominal aortic aneurysms for total endovascular repair using the Endurant endograft and Heli-FX EndoAnchors. J Endovasc Ther 2019;26:245-249.
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- Goudeketting SR, van Noort K, Ouriel K, Jordan WD Jr, Panneton JM, Slump CH, et al. Influence of aortic neck characteristics on successful aortic wall penetration of EndoAnchors in therapeutic use during endovascular aneurysm repair. J Vasc Surg 2018;68:1007-1016.
- Reyes Valdivia A, Duque Santos Á, Pitoulias G, Aracil Sanus E, Ocaña Guaita J, Gandarias Zúñiga C. Predictors of inadequate EndoAnchors aortic wall penetration for the Endosutured therapy in hostile neck patients. J Cardiovasc Surg (Torino) 2020;61:738-744.
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Related articles in VSI
Article
Original Article
Vasc Specialist Int (2023) 39:3
Published online March 24, 2023 https://doi.org/10.5758/vsi.230003
Copyright © The Korean Society for Vascular Surgery.
Anesthetic, Sedation, and Analgesic Technique for Successful Local Anesthetic EndoSuture Aneurysm Repair
Martin Hennessy1 and Keith Kelso Hussey2
Departments of 1Interventional Radiology and 2Vascular Surgery, Queen Elizabeth University Hospital, NHS Greater Glasgow & Clyde, Glasgow, UK
Correspondence to:Martin Hennessy
Department of Interventional Radiology, Queen Elizabeth University Hospital, 1345 Govan Road, Glasgow, Scotland G51 4TF, UK
Tel: +44-141-201-1100
E-mail: martin.hennessy@ggc.scot.nhs.uk
https://orcid.org/0000-0003-4195-572X
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Purpose: We aimed to describe our technique for and experience with elective endovascular aneurysm repair using EndoAnchors under local anesthesia.
Materials and Methods: We included seven patients with abdominal aortic aneurysms who underwent endovascular aneurysm repair using EndoAnchors with a standard regimen consisting of local anesthesia, intravenous sedation, and analgesia. The procedural and follow-up details were retrospectively reviewed.
Results: Six out of seven infrarenal abdominal aortic aneurysms were successfully treated with endovascular aneurysm repair using primary EndoAnchors under local anesthesia. One patient was converted to general anesthesia due to acute aneurysm thrombosis independent of EndoAnchor deployment during the procedure. Remifentanyl infusions of up to 3.2 mg/min, morphine doses up to 6 mg (median, 0.5 mg), and midazolam doses of up to 4 mg (mean, 1.4 mg) were used. The mean theater time was 83 minutes (range, 60–130 minutes). Two patients were discharged on day 0, and the mean hospital stay was one day. All patients were alive between 484 and 1,128 days post-procedure, with no aneurysm-specific reintervention.
Conclusion: The combination of local anesthesia, intravenous sedation, and analgesia is a viable strategy for timely and effective endovascular aneurysm repair using EndoAnchors. This technique may allow endovascular repair of more ruptured aneurysms using EndoAnchors with potential survival benefits.
Keywords: Abdominal aortic aneurysm, Anesthesia, Endovascular aneurysm repair, Conscious sedation
INTRODUCTION
EndoAnchors (EAs; Medtronic Cardiovascular) have been available as an adjunctive option for endovascular aneurysm repair (EVAR) for over a decade, with a phase 1 feasibility trial of EA (then EndoStaples; Aptus Endosystems Inc.) published in 2009 [1]. When used appropriately, they are safe with low published rates of device-specific adverse events [2].
Follow-up periods of up to three years have been reported, demonstrating survival and freedom from aneurysm-related mortality comparable to conventional EVAR [3]. Current evidence comes mainly from case series, cohort studies, and registry data, and the surrogate endpoint of sac regression is widely used [4]. Significant proportion of the abdominal aortic aneurysms (AAAs) in these publications would be unsuitable for conventional EVAR; therefore, EVAR with EA (also known as EndoSuture aneurysm repair [ESAR]) can expand the indications for infrarenal EVAR [5].
With no evidence of long-term outcomes after ESAR, its role in elective endovascular management of AAA remains to be rigorously defined or proven. However, EVAR provides better outcomes than open surgical repair (OSR) in ruptured AAA (RAAA), with a potentially increased benefit if EVAR is performed under local anesthesia (LA) [6]. It has been postulated that ESAR might expand the indications of EVAR among patients with RAAA [7]. Therefore, it is essential to be able to achieve ESAR without general anesthesia (GA), as the ability to perform the procedure under LA is an advantage of EVAR over OSR.
Numerous studies have described ESAR under LA (LA-ESAR) but have not detailed the anesthetic regimen. We aimed to present our experience with elective LA-ESAR and demonstrate its viability.
MATERIALS AND METHODS
This study was retrospective and observational. Procedural data were collected from the Radiology Information System and Picture Archiving and Collection System. Patient data were collected from electronic patient records. Procedures performed between July 24, 2019, and April 28, 2021, were included. The inclusion criterion was LA-ESAR for any AAA. Patients with elective and emergency LA-ESAR were eligible for inclusion.
The UK National Research Ethics Service guidelines that define the methods used for service evaluation state that ethical approval is not required for service evaluation [8]. Ethics approval and need for informed consent was waived by the Institutional Review Board of Queen Elizabeth University Hospital.
Our primary outcome was technical success; secondary outcomes included procedural times, procedural and follow-up complications, sac size changes, and re-interventions.
Technical success was defined as deployment of the stent graft and EAs without GA. We defined two specific time measures: device time and theatre time. Device time was defined as the duration between the initial and final angiograms for the procedure. All devices (stent grafts and EAs) were deployed between these angiograms. Theatre time was defined as the duration between the patient entering and leaving the operating theatre. EA maldeployment was defined as <2 mm of aortic-wall penetration by an EA on follow-up computed tomography (CT). Percutaneous closure was performed in all cases using the suture-mediated closure device, Perclose ProGlide system (Abbott Vascular).
Data were analyzed using the R language and environment for statistical computing (R Foundation for Statistical Computing) in an RStudio integrated development environment [9,10]. The Shapiro–Wilk test was used to assess the normality of data distribution. No further statistical tests were deemed appropriate or necessary.
RESULTS
1) EVAR data of our center
During the 644 days (92 weeks) of data collection, 97 EVAR were performed. Of these, 77 were elective. Of these 77 procedures, 21 (27%), 2 (3%), and 54 (70%) were performed under LA, spinal anesthesia, and GA, respectively. Twelve of 77 patients underwent ESAR, of which seven (58%) were performed under LA. Among patients undergoing elective EVAR, bilateral percutaneous access, bilateral open surgical access, and percutaneous access in one side and surgical access in the other side was performed in 73 (95%), 3 (4%), and 1 (1%) patients, respectively. Of the five EVAR performed for rupture, three were performed under LA. No ESAR was performed in an emergency setting.
2) Patient demographics and aneurysm details
All seven patients who underwent LA-ESAR were male. All LA-ESAR procedures were elective. Patient ages ranged from 59 to 83 years and were normally distributed, with a mean of 71 years and standard deviation (SD) of 8 years. Five and two patients were classified as American Society of Anesthesiologists (ASA) class 3 and 4, respectively. The age of the five patients who underwent ESAR under GA (GA-ESAR) ranged from 62 to 77 years (mean, 72 years; SD, 6 years), and two, two, and one patients were classified as ASA class 2, 3, and 4, respectively.
3) Technical success and indications for EA
The technical success rate of LA-ESAR was 86% (6 out of 7 cases). One patient developed acute aneurysm thrombosis after deployment of the bifurcated device and was converted to GA due to ischemic lower limb pain. No further details of this case are presented in the Results section.
Regarding indications for EA, two aneurysms had conical necks, one had a wide and conical neck, one patient was very young with an incidental aneurysm discovery during surgical workup for bowel cancer, one relatively young patient had a short necked (<10 mm) aneurysm, and one patient had atherosclerotic disease in the aneurysm neck causing concern about seal (but not of sufficient thickness to contra-indicate EA).
4) Anesthesia, sedation, and analgesia regimen
All LA-ESAR procedures were performed percutaneously. We administered 10 mL of 1% lignocaine hydrochloride with 100 µg/20 mL adrenaline (Xylocaine; Aspen Pharma Trading Ltd.) mixed with 10 mL of levobupivacaine hydrochloride (Chirocaine, 50 mg/10 mL; AbbVie Ltd.) in each groin. We prioritized cutaneous and peri-arterial infiltration and used the full volume in each case. No patients required additional LA.
Intravenous analgesia was achieved using a combination of intravenous remifentanil (Wockhardt UK Ltd.) infusion and boluses of morphine sulfate (Torbay Pharmaceuticals) and midazolam hydrochloride (AAH Pharmaceuticals Ltd.). The baseline dose of remifentanil was calculated according to the patient’s weight and infusion rates ranged from 0.3-0.7 mg/min to 1-3.2 mg/min (from the lightest to heaviest patient). The morphine dose ranged from 0 to 6 mg and was abnormally distributed with a median of 0.5 mg and an interquartile range of 0-5 mg. Three patients did not receive morphine. The midazolam dose ranged from 0 to 4 mg and was normally distributed, with a mean of 1.4 mg (SD, 1.5 mg). Two patients did not receive midazolam. The medications administered to each patient are listed in Table 1.
-
Table 1 . Analgesia and sedation received by each patient undergoing endosuture aneurysm repair under local anesthesia.
Patient Remifentanyl infusion rate (mg/min) Total morphine dose (mg) Total Midazolam dose (mg) Weight (kg) 1 1.5-1.6 6 1 60 2 1.2-1.7 5 2 83 3 1.0-3.2 0 0 94 4 1.8-2.0 1 4 88 5 0.5-1.0 0 1.5 85 6 0.3-0.7 0 0 99
All sedatives and analgesics were administered at the discretion of the anesthetist. Remifentanil infusion was started before access in all patients, except in one patient in whom it was started shortly thereafter. All four patients who received midazolam were administered a single dose at the start of the procedure. Three patients received regularly spaced extra doses during the procedure at the discretion of anesthetist. All three patients who received morphine were administered a bolus at the start of the procedure. Two of the three patients received additional doses of morphine: one patient received additional doses at the time of kissing balloon angioplasty at the aortic bifurcation and at the time of Proglide tightening at the end of the procedure, and another patient received an additional dose at the time of Proglide tightening at the end of the procedure. Five of the six patients received one or two doses of oral morphine (5 mg) after the procedure in the recovery room. All six patients received one or more doses of oral paracetamol/acetaminophen before discharge. No patient required additional sedative medication after the procedure. No patient was discharged on opiate analgesia.
5) Procedural details
Bifurcated stent grafts (Endurant II or IIs; Medtronic Cardiovascular) were used for all ESAR procedures. Unilateral internal iliac artery embolization was additionally performed in one patient. The number of EAs ranged from 6 to 9 and was abnormally distributed, with a median of 7 (interquartile range, 6-8). Among patients who underwent GA-ESAR, 6 and 10 EAs were deployed in four and one patients, respectively.
The Heli-FX guide (Medtronic Cardiovascular) catheter is a 16-Fr outer diameter device, and in all cases, it could be inserted via one of the sheaths already in situ for the EVAR.
Fluoroscopy time ranged from 12 to 39 minutes with a mean of 22 minutes (SD, 10 minutes). For GA-ESAR, the fluoroscopy time ranged from 24 to 38 minutes (mean, 31 minutes; SD, 6 minutes). The mean fluoroscopy time for elective EVAR (without EA) performed at our center during the same period was 22 minutes. About one-third of these elective EVAR involved an EVAR adjunct, the most common being unilateral internal iliac artery embolization.
Device time ranged from 26 to 71 minutes with a mean of 43 minutes (SD, 16 minutes). For GA-ESAR, device time ranged from 43 to 81 minutes (mean, 61 minutes; SD, 17 minutes). Theatre time ranged from 60 to 130 minutes with a mean of 83 minutes (SD, 27 minutes). For GA-ESAR, theatre time ranged from 115 to 170 minutes (mean, 142 minutes; SD, 24 minutes).
6) Procedural complications
One patient reported unilateral ischemic limb pain after deployment of all devices. After a brief discussion, agitation was managed with a dose of midazolam, and an angiogram was performed to confirm that there was no stent-graft thrombosis. The large caliber sheath was removed from the affected side. Angiography was repeated from the contralateral side to assess ESAR. At this time, the pain had resolved, and the patient’s leg was not clinically ischemic; therefore, infra-inguinal angiography was not performed.
One patient reported back pain on the left side during EA deployment on the left posterolateral side. The pain was self-limiting.
7) Outcomes
To facilitate early discharge, patients were mobilized within 2 hours of the procedure. Patients were discharged between 0 and 3 days after the procedure, with a mean of day 1 (SD, 1 day). Two patients were discharged on the day of the procedure. All patients remained alive at 484-1,128 days after the procedure. Patients who underwent GA-ESAR were discharged between 1 and 4 days after the procedure (mean, 2 days; SD, 1 day). All patients who underwent GA-ESAR remained alive at 486-981 days after the procedure.
On CT review, 40/43 (93%) EAs adequately penetrated through the aortic wall, with no patient having more than one inadequately penetrated EA. In patients who underwent GA-ESAR 30 of 34 (88%) EAs adequately penetrated through the aortic wall. No EA moved, embolized, or caused any clinical complications. Postoperative CT 12-17 months after ESAR showed an unchanged aneurysm sac size in one patient and >5 mm sac regression in five patients (Fig. 1). No endoleaks or other adverse outcomes were observed on CT.
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Figure 1. Aneurysm sac size at baseline (pre-ESAR) and 12-17 months post-ESAR. Each patient is represented by a different symbol. Baseline and post-ESAR sac sizes are connected with a dashed line in case of sac size decrease >5 mm and a solid line otherwise. ESAR, EndoSuture aneurysm repair.
Regarding reintervention, one patient underwent common femoral artery endarterectomy and external iliac artery stenting for ischemic leg pain. This patient was different from the patient who had ischemic pain during LA-ESAR.
DISCUSSION
We presented our experience with LA-ESAR and described the anesthesia, sedation, and analgesia regimen used. In addition to describing the consistent LA regimen used, we documented that along with a remifentanyl infusion that varies according to both patient weight and requirement for analgesia, small doses of morphine and midazolam were required.
LA-ESAR has been reported in previous case series and in some outcomes published from the ANCHOR registry; however, none of these detailed the anesthesia, sedation, and analgesia regimen used [11-14].
In our series of seven patients, the technical success rate was 86%. This was due to a single case of aneurysm thrombosis that occurred during cannulation of the contralateral gate, and was therefore independent of EA deployment. This is the only case of intraprocedural aneurysm thrombosis that we encountered in the past several years at our institution, and its cause was not definitively determined. It has been included, as we chose to analyze technical success in an intention-to-treat manner. The procedure, including EA deployment, was completed after conversion to GA. The stent-graft thrombosis was managed endovascularly, and the patient was discharged on the second post-operative day [15]. No further complications were observed.
The procedure was well-tolerated by the remaining patients. Particularly, EA deployment caused pain in one patient during deployment of EA. Surprisingly, the pain was accurately localized to the site of EA deployment, but it was self-limiting.
Our rate of EA maldeployment was 7%, which compares favorably with both our EA maldeployment rate in GA-ESAR and with those of recent detailed analyses of inadequate aortic wall penetration, which reported rates ranging from 17% to 26% [16,17]. We believe that LA-ESAR can only be said to be successful if EAs are deployed appropriately for function.
Central to successful LA-ESAR is a time-efficient procedure, involving percutaneous access, closure, stent-graft deployment, and EA deployment. Our patients spent a mean of 83 min and a maximum of 130 minutes in the operating theatre, which compares favorably with a registry that reported a mean procedure time of 138 minutes [14]. Compared to GA-ESAR, the mean theatre time reduced by 59 minutes, allowing for increased patient throughput.
Given that EAs are deployed under fluoroscopy, we recorded fluoroscopy time for the entire procedure as a surrogate comparator and compared it to fluoroscopy time for elective infrarenal EVARs during the study period at our institution. The mean fluoroscopy time was 22 minutes for both groups. Two case series in which the majority of ESAR were performed under LA reported fluoroscopy times ranging from a mean of 12 minutes (for a mean of 5 EAs) to a median of 51 minutes (for a median of 9 EAs) [11,13].
A key limitation of our study is that while LA-ESAR is clearly viable, its indications remain unclear. This limitation is related to the major issue around EAs: what is their role in the endovascular management of infrarenal AAA? We believe that EA clearly expands the availability of EVAR to patients with RAAA. The UK National Institute for Health and Care Excellence (NICE) guidance on the management of AAA is generally skeptical of EVAR but recommends it over OSR for RAAA [6]. Within its evidence review is the non-randomized IMPROVE trial, which suggests that EVAR under LA for RAAA may have lower short-term mortality than EVAR under GA [18]. In a recent review of CT scans of 90 patients with RAAA, of the 46 patients who were unsuitable for conventional EVAR, 24 could have been treated with ESAR, an absolute increase of 27% [7]. Regardless of the long-term role of EAs, LA-ESAR could be applied to these patients with RAAA.
Our intention was to demonstrate that LA-ESAR is feasible in an emergency setting; however, we only presented patients who underwent elective procedures. In our institution, LA-ESAR for RAAA was not required till recently, when we applied it for a large symptomatic aneurysm in an unwell patient. The procedure followed the principles outlined herein and was successful with regard to all parameters.
A perceived issue with ESAR is increased radiation exposure compared to conventional EVAR due to the extra fluoroscopy required for EA deployment. Indeed, draft guidance from NICE suggests that EA deployment reportedly increases radiation exposure during the procedure [19]. While we have shown that fluoroscopy times for LA-ESAR can be as low as those for conventional EVAR, the C-arm angles used for EA deployment may mean that the fluoroscopy dose and total procedure dose are somewhat higher during ESAR. We did not record these data, but are unconvinced that the radiation dose increase would be detrimental to the patient.
The combined guidelines of the Society of Interventional Radiology and the Cardiovascular and Interventional Radiology Society of Europe are archaic, and neither society has published guidance on the use of EA in EVAR [20]. A more recent guideline from NICE states that complex EVAR (ESAR is considered complex EVAR in their definition) should not be offered to patients in whom OSR is suitable, except in the context of a clinical trial [6]. The same guideline suggests that EVAR may be better than OSR for RAAA (especially for males aged >70 years) and highlights the ability to perform EVAR under LA. In our opinion and local experience, using EA as an adjunct can be considered standard EVAR and can be offered with a simple LA, sedation, and analgesia regimen.
CONCLUSION
In summary, we described in detail the anesthesia, sedation, and analgesia regimen used to perform successful ESAR under LA. This regimen can be easily implemented through communication and collaboration among interventional radiologists, vascular surgeons, and anesthetists. Although the role of EA in elective EVAR is undefined, LA-ESAR may offer survival benefits to patients with RAAA whose only other option is OSR.
FUNDING
None.
CONFLICTS OF INTEREST
The authors have nothing to disclose.
AUTHOR CONTRIBUTIONS
Concept and design: all authors. Analysis and interpretation: MH. Data collection: MH. Writing the article: MH. Critical revision of the article: all authors. Final approval of the article: all authors. Overall responsibility: MH.
Fig 1.
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Table 1 . Analgesia and sedation received by each patient undergoing endosuture aneurysm repair under local anesthesia.
Patient Remifentanyl infusion rate (mg/min) Total morphine dose (mg) Total Midazolam dose (mg) Weight (kg) 1 1.5-1.6 6 1 60 2 1.2-1.7 5 2 83 3 1.0-3.2 0 0 94 4 1.8-2.0 1 4 88 5 0.5-1.0 0 1.5 85 6 0.3-0.7 0 0 99
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