Impact of Hybrid Operating Rooms on Long-Term Clinical Outcomes Following Fenestrated and Branched Endovascular Aortic Repair

Abstract

Purpose:

Evaluate the impact of hybrid operating room (HOR) guidance on the long-term clinical outcomes following fenestrated and branched endovascular repair (F-BEVAR) for complex aortic aneurysms.

Materials and Methods:

Prospectively collected registry data were retrospectively analyzed to compare the procedural, short- and long-term outcomes of consecutive F-BEVAR performed from January 2010 to December 2014 under standard mobile C-arm versus hybrid room guidance in a high-volume aortic center.

Results:

A total of 262 consecutive patients, including 133 patients treated with a mobile C-arm equipped operating room and 129 with a HOR guidance, were enrolled in this study. Patient radiation exposure and contrast media volume were significantly reduced in the HOR group. Short-term clinical outcomes were improved despite higher case complexity in the HOR group, with no statistical significance. At a median follow-up of 63.3 months (Q1 33.4, Q3 75.9) in the C-arm group, and 44.9 months (Q1 25.1, Q3 53.5, p=0.53) in the HOR group, there was no statistically significant difference in terms of target vessel occlusion and limb occlusion. When the endograft involved 3 or more fenestrations and/or branches (complex F-BEVAR), graft instability (36% vs 25%, p=0.035), reintervention on target vessels (20% vs 11%, p=0.019) and total reintervention rates (24% vs 15%, p=0.032) were significantly reduced in the HOR group. The multivariable Cox regression analysis did not show statistically significant differences for long-term death and aortic-related death between the 2 groups.

Conclusion:

Our study suggests that better long-term clinical outcomes could be observed when performing complex F-BEVAR in the latest generation HOR.

Keywords

hybrid room image fusion cone beam CT complex aortic treatment FEVAR BEVAR long-term result target vessel instability endograft instability reintervention personalized medicine

Introduction

Hybrid operating rooms (HORs) combine an optimal open surgical environment with advanced imaging applications, such as high-quality imaging, contrast-enhanced cone beam computed tomography (CBCT), and intraoperative fusion guidance.

CBCT is a computed tomography (CT)-like acquisition performed through rotational angiography. Its routine introduction during standard and complex endovascular aneurysm repairs (EVARs) allows intraoperative three dimensional assessment of technical success and detection of endograft-associated complications that are not easily identified with 2-dimensional (2D) digital subtraction angiography (DSA).^1,2 By allowing intraoperative assessment, CBCT supports immediate revision, which may reduce the rate of secondary interventions and their associated morbidity.³

Intraoperative fusion guidance overlays a 3D model of the surgeon’s operating plan based on preoperative computed tomography angiography (CTA) over live fluoroscopy, thus provides a 3D roadmap to facilitate endovascular navigation and endograft placement.^4,5 The use of image fusion guidance has been associated with several procedural benefits for patients undergoing standard and complex EVAR. Prior publications reported a significant reduction in both operator and patient radiation exposure and contrast medium injection with routine use of fusion guidance by trained operators applying the ALARA (as low as reasonably achievable) principles.^6–8

Tenorio et al⁹ reported an improvement in technical success rate when performing complex EVAR in a modern HOR compared with a standard surgical theatre equipped with a mobile C-arm. However, no data are currently available on the impact of HOR on the long-term clinical outcomes, including reintervention rates, following fenestrated and branched endovascular repair of complex aortic aneurysms (F-BEVAR).

The aim of this study is to compare the procedural, early, short- and long-term outcomes of F-BEVAR performed in a standard surgical theatre equipped with a mobile C-arm versus in a last-generation HOR.

Materials and Methods

Study Population

This retrospective analysis of prospectively collected registry data compared the outcomes of F-BEVAR performed either under mobile C-arm guidance or in a modern hybrid room in a high-volume aortic center. The analysis focused on consecutive cases performed between January 2010 and December 2014 (before 2010 the annual number of F-BEVAR procedures was lower than 30). Inclusions were stopped in December 2014 to have long-term follow-up available for all patients (Figure 1).

Procedure

All cases involved implantation of an aortic endograft with 1 to 5 fenestrations and/or branches (Fen/Bra) for the celiac artery (CA), superior mesenteric artery (SMA), left renal artery (LRA), right renal artery (RRA), and/or polar renal arteries. F-BEVAR with 3 or more fenestrations were classified as complex F-BEVAR.

All patients were treated with custom-made stent grafts within the instructions for use from the manufacturer (Cook Medical, Bloomington, IN, USA). General anesthesia was used in all patients with an open arterial exposure or a percutaneous approach of the femoral arteries. The fenestrations were connected to their respective target vessels with covered balloon-expandable stents (Advanta V12, Atrium Medical Corporation, Hudson, NH, USA), and branches with self-expandable covered stents (Fluency, Bard Peripheral Vascular, Tempe, AZ, USA).

All cases were performed by, or under the supervision of, a single senior surgeon. ALARA principles were strictly followed during all procedures, including reduced fluoroscopy time, reduced detector-to-patient and increased source-to-patient distances, maximized collimation, reduced use of magnification, use of protective barriers, and optimized working angulations.

Mobile C-Arm Group

Between January 2010 and October 2012, all cases were performed in a standard operating room equipped with a motorized mobile C-arm (OEC 9900, GE Healthcare, Chalfont, UK) and a floating table. Half-dose settings with pulse mode (8 frames/s) were used by default. Technical success was assessed with a 2D anteroposterior completion angiogram.

HOR Group

From November 2012, all cases were performed in a last-generation HOR, equipped with a 30×30 cm flat panel detector, fusion imaging technology and CBCT (Discovery IGS 730 with EVAR ASSIST; GE Healthcare, Chicago, IL, USA). Default low-dose settings were used with fluoroscopy and DSA frame rates of 7.5 and 2 frames/s, respectively. Minimization of the detector to patient distance was performed automatically by the X-ray system throughout the procedure, using patient contouring with capacitive sensor technology (Innova Sense, GE Healthcare). Additionally, magnification was avoided through the use of a digital zoom feature and a 56-inch large display monitor. Before each procedure, bone and aortic 3D models were reconstructed from the preoperative CTA scan on a workstation (Advantage Workstation; GE Healthcare) and sent to the X-ray system for a 2D/3D registration process.¹⁰ A completion 2D antero-posterior angiogram and a noncontrast CBCT were performed to assess technical success.

Follow-up

In the mobile C-arm group, CTA was performed at 1 and 12 months postoperatively and then on a two-year basis in the absence of complications on duplex ultrasonography. In the HOR group, patients underwent an intraoperative completion CBCT combined with a contrast-enhanced ultrasound before hospital discharge. At 6 and 18 months, a CTA was performed and then repeated every 2 years in the absence of complications.

All patients were monitored with annual duplex ultrasound and postoperative appointments during the first 3 years and then at 5 years in the absence of complications.

End-Points

Procedural, short- and long-term clinical outcomes were compared between the mobile C-arm and the HOR groups.

Procedural data included procedure time, contrast volume and dose area product (DAP) expressed in Gy·cm². Short-term clinical outcomes included procedural technical success, mortality, incidence of major adverse events (MAE) and early reintervention within 30 days.

Long-term clinical outcomes primarily included occlusion of target vessels, limb occlusion, death, and aortic related death during 5-years follow-up. Secondary long-term outcomes included target vessel instability and graft instability, two composite endpoints, reinterventions on fenestrations and/or branches, and total reinterventions. All the outcomes are defined in Table 1.

Table 1.

Clinical Outcomes Definitions.

Outcome	Definition
Technical success	Successful placement of the aortic stent and all bridging stents in their intended side branches and/or fenestrations, absence of type I and type III endoleaks, and patent target vessels on postoperative completion CBCT in the HOR group, and on 1-month postoperative CTA in the C-arm group.
Target vessel occlusion	Absence of lumen patency on any target vessel perfused by fenestration or branch identified on any of the 5-year follow-up CTA or duplex ultrasound.
Reintervention on target vessels	Includes all secondary interventions performed on target vessels perfused by fenestrations or branches during 5-year follow-up.
Total reintervention	Includes all secondary interventions related to the initial procedure or to the endograft and its target vessels during 5-year follow-up (staged procedures are not included).
Target vessel instability	Composite endpoint integrating any branch- or fenestration-related complication leading to aneurysm rupture, death, occlusion, component separation or reintervention to maintain branch patency or treat a branch or fenestration-related component separation or endoleak.¹⁹
Graft instability	Composite endpoint integrating any type I or III endoleak, kink, or occlusion of a limb or a target vessel during 5-year follow-up.

Abbreviations: CBCT, cone beam computed tomography; CTA, computed tomography angiography; HOR, hybrid operating room.

The study was performed in accordance with the Institutional Ethics Committee rules. Individual consent for intervention and retrospective analysis was obtained from all patients.

Statistical Analysis

Continuous variables were reported as mean with standard deviation (SD) and qualitative variables as percentages with absolute numbers. Follow-up length was reported as median with interquartile limits (Q1, Q3).

To improve the estimation of the effect sizes and relative uncertainty, a coarsened exact matching algorithm was employed in order to reduce unbalances (by age and sex) between the HOR and C-arm groups.¹¹

Associations between the study endpoints and the imaging system used (C-arm or HOR) were assessed by multivariable models. Logistic regression models were used for binary outcomes, Poisson regression for count outcomes, linear models for continuous outcomes, and proportional hazard Cox regression for the time-to-event endpoints: Results are reported as odds ratios (OR), rate ratios (RR), mean differences (MD), and hazard ratios (HR) respectively, along with 95% confidence intervals (CI). Subgroup-analysis was performed on complex F-BEVAR group only.

Multivariable models were built with a covariate set defined a priori, which included type of aneurysm (pararenal and thoracoabdominal aneurysms), preoperative aneurysm maximum diameter, graft configuration type (fenestrations, branches, both), number of fenestrations and/or branches in the graft configuration, diabetes mellitus (DM), smoking, coronary artery disease (CAD), chronic obstructive pneumopathy disease (COPD), and chronic kidney disease (CKD). For the complex F-BEVAR subgroup, we used the same covariate set without the number of fenestrations and/or branches in the graft configuration.

For the time-to-event analyses, proportional hazard assumption was checked by visual assessment of the minus log cumulative-hazard functions and a formal Grambsch-Therneau test of the scaled Schoenfeld residuals. No correction for multiple testing has been made, and p-values <0.05 were considered as statistically significant.

All statistical analyses were conducted using Stata 16.¹²

Results

Patient Data

From January 2010 to December 2014, 262 consecutive F-BEVAR procedures were performed at our institution, including 133 patients treated in a mobile C-arm equipped surgical theatre until October 2012, and 129 patients in the HOR thereafter.

Patients’ clinical and demographic characteristics are summarized in Table 2, with no statistically significant difference found between the 2 groups.

Table 2.

Demographic, Anatomical Features of Patients and Graft Configurations in the C-Arm and Hybrid Operating Room (HOR) Groups.^a

	C-Arm Group (n=133)	HOR Group (n=129)	p
Age, years, mean (SD)	70.68 (8.25)	70.40 (8.41)	0.785
Male	122 (91.73)	122 (94.57)	0.466
CAD	66 (49.62)	51 (39.53)	0.108
COPD	55 (41.35)	39 (30.23)	0.071
CKD	32 (24.06)	35 (27.13)	0.575
DM	29 (21.80)	24 (18.60)	0.542
Smoking	116 (87.2)	116 (89.9)	0.693
Type of aneurysm:
Pararenal and type IV TAA	101 (75.94)	99 (76.74)	0.886
Type I-II-III-V TAA	32 (24.06)	30 (23.26)	0.886
Aneurysm diameter, mm, mean (SD)	59.77 (9.87)	59.54 (8.99)	0.848
Single fenestration/branch	2 (1.5)	3 (2.3)	0.626
Two fenestrations/branches	41 (30.8)	10 (7.8)	<0.001
Three fenestrations/branches	43 (32.3)	40 (31.0)	0.817
Four or more fenestrations/branches	47 (35.3)	76 (58.9)	<0.001
Total number of target vessels	403	449	<0.001
Mean number of fenestrations and/or branches per graft	3	3.5	<0.001
Stent-graft configuration
Fenestration	99 (74.4)	105 (81.4)	0.263
Branches	17 (12.8)	9 (6.9)
Fenestration + branches	17 (12.8)	15 (11.6)

Abbreviations: CAD, coronary artery disease; CKD, chronic kidney disease; COPD, chronic obstructive pulmonary disease; DM, diabetes mellitus; HOR, hybrid operating room; TAA, thoraco-abdominal aneurysm.

Values are reported as number (%) unless otherwise indicated.

Stent graft configurations are also described in Table 2. The total number of target vessels was 403 and 449 in the C-arm and HOR groups, respectively. Stent graft design (fenestrations only, branches only, or fenestrations and branches) was similar between the 2 groups. The mean number of fenestrations and/or branches per graft was significantly higher in the HOR group (3.5 vs 3, p<0.001), including more 4-fenestrations/branches endografts (respectively 58.9% vs 35.3%, p<0.001), demonstrating an increased in case complexity in the HOR group.

Procedural and Short-Term Clinical Outcomes

Procedural and short-term data are reported in Table 3.

Table 3.

Procedural and Short-Term Clinical Outcomes.^a

	Total					Complex F-BEVAR Group
	C-Arm Group (n=133)	HOR Group (n=129)	RR	95% CI	p	C-Arm Group (n=90)	HOR Group (n=116)	RR	95% CI	p
Procedural time, min, mean (SD)	181.1 (69.8)	201.3 (80.8)	1.07	1.05 to 1.09	<0.001	201.5 (71.9)	208.0 (80.9)	1.05	1.03 to 1.07	<0.001
Contrast, mL, mean (SD)	142.2 (63.2)	125 (50.9)	−21.60	−35.99 to −7.22	0.003	155.9 (66.6)	128.3 (51.3)	−21.18	−37.44 to −4.91	0.011
DAP, Gy·cm², mean (SD)	9355.5 (8922.9)	7087.4 (6230.5)	−2552.57	−4464.47 to −640.67	0.009	11286.4 (10012.8)	7212.9 (5035.6)	−3208.06	−5381.01 to −1035.11	0.004
	C-Arm Group (n=133)	HOR Group (n=129)	OR	95% CI	p	C-Arm Group (n=90)	HOR Group (n=116)	OR	95% CI	p
Technical success	123 (92.5)	123 (95.3)	3.19	0.85 to 11.90	0.085	80 (88.9)	110 (94.8)	2.59	0.77 to 8.72	0.124
30-day MAE	71 (53.4)	78 (60.5)	1.20	0.69 to 2.06	0.516	56 (62.2)	69 (59.5)	0.88	0.48 to 1.60	0.668
Early reintervention	13 (9.8)	7 (5.4)	0.53	0.20 to 1.37	0.189	9 (10.0)	6 (5.2)	0.38	0.12 to 1.19	0.097
30-day mortality	7 (5.3)	5 (3.9)	0.77	0.21 to 2.88	0.694	7 (7.8)	4 (3.4)	0.42	0.10 to 1.65	0.212

Abbreviations: DAP, dose-area product; F-BEVAR, fenestrated/branched endovascular aneurysm repair; HOR, hybrid operating room; MAE, major adverse events; OR, odds ratio; RR, rate ratio.

Values are reported as number (%) unless otherwise indicated. Boldfaced p values indicate statistical significance.

In the total cohort, the contrast media volume (mean 142.2 vs 125 mL, RR −21.6, 95% CI −35.99 to −7.22, p=0.003) and DAP (mean 9355.5 vs 7087.4 Gy·cm², Q1 4540, Q2 6730 vs Q3 8816, Q4 38948, RR -2552.6, 95% CI −4464.5 to −640.7, p=0.009) were significantly decreased in the HOR group, with a slightly longer procedure time (mean 181.1 vs 201.3 min, RR 1.07, 95% CI 1.05 to 1.09, p<0.001), again possibly due to the increased case complexity in the HOR group. Similar significant results were observed for the complex F-BEVAR group.

Short-term clinical outcomes were not significantly different between the 2 groups, though higher technical success and decreased early reintervention and mortality rates were observed in the HOR group, both in the full cohort and the complex F-BEVAR subset (p>0.05).

The reintervention rate was 9.8% (13 cases) in the C-arm group and 5.4% (7 cases) in the HOR group. Indications for reintervention in the C-arm group were as follows: type III endoleaks (n=2) requiring SMA and LRA stenting; target vessel stenosis (n=1) requiring SMA stenting; acute limb ischemia (n=4); access site complication (n=3); abdominal compartment syndrome requiring laparotomy (n=2); and ilio-lumbar artery embolization (n=1). In the HOR group: type III endoleak (n=1) requiring LRA stenting; acute mesenteric ischemia requiring bowel resection (n=2); subacute limb ischemia (n=1); access site complications (n=2); and negative exploratory laparotomy (n=1).

Long-Term Clinical Outcomes

The median follow-up was 63.3 months (Q1 33.4, Q3 75.9) in the C-arm group and 44.9 months (Q1 25.1, Q3 53.5) in the HOR group (p=0.53). Long-term clinical outcomes are reported in Table 4.

Table 4.

Long-Term Clinical Outcomes Analysis.^a

	Total					Complex F-BEVAR Group
	C-Arm Group (n=133)	HOR Group (n=129)	HR	95% CI	p	C-Arm Group (n=90)	HOR Group (n=116)	HR	95% CI	p
Target vessel occlusion	12 (9.0)	14 (10.9)	1.30	0.44 to 3.68	0.639	10 (11.1)	13 (11.2)	1.74	0.57 to 5.37	0.332
Limb occlusion	6 (4.5)	1 (0.8)	0.30	0.03 to 3.16	0.320	4 (4.4)	1 (0.9)	0.42	0.02 to 8.26	0.568
Death	54 (40.6)	32 (24.8)	0.92	0.58 to 1.45	0.716	38 (42.2)	31 (26.7)	1.00	0.61 to 1.65	0.979
Aortic-related death	3 (2.3)	6 (4.7)	1.79	0.67 to 4.77	0.241	2 (2.2)	5 (4.3)	1.16	0.41 to 3.29	0.766
	C-Arm Group (n=133)	HOR Group (n=129)	OR	95% CI	p	C-Arm Group (n=90)	HOR Group (n=116)	OR	95% CI	p
Target vessel instability	27 (20.3)	21 (16.3)	0.65	0.32 to 1.33	0.244	21 (23.3)	19 (16.4)	0.52	0.24 to 1.11	0.093
Graft instability	43 (32.3)	32 (24.8)	0.61	0.33 to 1.21	0.112	32 (35.6)	29 (25.0)	0.48	0.25 to 0.95	0.035
Reintervention on target vessels	21 (15.8)	15 (11.6)	0.51	0.23 to 1.15	0.106	18 (20.0)	13 (11.2)	0.36	0.15 to 0.84	0.019
Total reintervention	29 (21.8)	20 (15.5)	0.55	0.27 to 1.12	0.099	22 (24.4)	18 (15.5)	0.43	0.20 to 0.93	0.032

Abbreviations: HOR, hybrid operating room; HR, hazard ratio; F-BEVAR, fenestrated/branched endovascular aneurysm repair; OR, odds ratio.

Values are reported as number (%) unless otherwise indicated. Boldfaced p values indicate statistical significance.

In the total cohort, the target vessel occlusion rate (9.0% vs 10.9%, p=0.64; HR 1.30; 95% CI 0.44 to 3.68) was similar between both groups. The limb occlusion rate (4.5% vs 0.8%, p=0.32; HR 0.30; 95% CI 0.03 to 3.16) was lower in the HOR group with no statistical significance. In the complex F-BEVAR cohort, the target vessel occlusion (11.1% vs 11.2%, p=0.33; HR 1.74; 95% CI 0.57 to 0.37) was similar between both groups. The limb occlusion rate (4.4% vs 0.9%, p=0.57; HR 0.42; 95% CI 0.02 to 8.26) was lower in the HOR group with no statistical significance.

In the total cohort, the death rate (40.6% vs 24.8%, p=0.72; HR 0.92; 95% CI 0.58 to 1.45) was lower in the HOR group, while aortic death rate (2.3% vs 4.7%, p=0.24; HR 1.79; 95% CI 0.67 to 4.77) was similar between the groups, both with no statistical significance. Analogous statistically nonsignificant results were observed in the complex group, death rate (42.2% vs 26.7%, p=.98; HR 1.00; 95% CI 0.61 to 1.65) lower in the HOR group, and aortic death rate (2.2% vs 4.3%, p=0.77; HR 1.16; 95% CI 0.41 to 3.29) similar between the groups. Kaplan-Meier analysis of freedom from target vessel occlusion, death, and aortic-related death in the complex F-BEVAR is presented in Figure 2.

A decrease in target vessel instability (20.3% vs 16.3%, p=0.24; OR 0.65; 95% CI 0.32 to 1.33) and graft instability (32.3% vs 24.8%, p=0.11; OR 0.61; 95% CI 0.33 to 1.21) was observed in the HOR total cohort group, though not statistically significant. A similar statistically nonsignificant decrease in the reintervention rate on target vessels (15.8% vs 11.6%, p=0.11; OR 0.51; 95% CI 0.23 to 1.15) and in the total reintervention rate (21.8% vs 15.5%, p=0.10; OR 0.55; 95% CI 0.27 to 1.12) was observed. While for the complex F-BEVAR cohort, a decrease in target vessel instability (23.3% vs 16.4%, p=0.09; OR 0.52; 95% CI 0.24 to 1.11) and graft instability (35.6% vs 25.0%, p=0.035; OR 0.48; 95% CI 0.25 to 0.95) was observed in the HOR group. A statistically significant decrease in the reintervention rate on target vessels (20.0% vs 11.2%, p=0.019; OR 0.36; 95% CI 0.15 to 0.84) and in the total reintervention rate (24.4% vs 15.5%, p=.032; OR 0.43; 95% CI 0.20 to 0.93) was also observed.

Forest plot of all long-term outcomes in both the total cohort and the complex endograft subgroup is presented in Figure 3.

Discussion

Several studies have reported the benefits of hybrid rooms reducing operators and patient radiation exposure, contrast medium volume or procedure time in standard or complex EVAR.^6,8,13,14 Other frequently reported benefits of hybrid rooms are the higher image quality, the available advanced imaging applications such as fusion imaging to ease navigation and increase the accuracy of complex endografts deployment, and the availability of CBCT to intraoperatively depict and correct any technical issues.^1,3,9,15 Routine use of fusion imaging and CBCT should theoretically help increase short- and long-term technical success rates of all endovascular procedures, especially F-BEVAR. Tenorio et al¹⁶ reported in 2019 a review of 386 patients treated with F-BEVAR between 2007 and 2017 on different imaging systems. They observed an increased technical success rate when F-BEVAR was performed in a modern HOR with fusion imaging and CBCT (99.4% vs 98.8%, p<0.05), which was associated with lower rates of 30-day mortality (1% vs 4%, p<0.05) and early reinterventions (4% vs 10%, p<0.05).¹⁶ Our study reported a significant decrease in contrast medium volume and radiation exposure for procedures performed in hybrid rooms, which is consistent with the literature.^6,8,17,18 Our technical success increase was however not statistically significant, possibly due to a higher case complexity in the HOR group with higher total number of target vessels and average number of fenestrations and/or branches per graft (p<0.01). This evolution in our practice, was also observed in other groups who increased the extension of the proximal landing zone as their experience grew to achieve a more durable sealing^19–22; it was expected to result in increased technical failure, as reported by Mastracci et al²³ and Roy et al²² with higher reintervention and type Ic and III endoleaks occurrence rates observed in patients treated with 3 fenestrations or more. On the contrary, we achieved similar technical success rates with lower radiation exposure and contrast volumes while performing more complex cases in the HOR group, which we believe is not only related to operator’s growing experience but rather to the secured imaging environment and routine use of advanced imaging applications provided by HOR.

Although not significant, a similar improvement was observed in early reintervention (9.8% in the C-arm group vs 5.4% in the HOR group, p=0.19) and 30-day mortality rates (5.3% in the C-arm group vs 3.9% in the HOR group, p=0.69) despite increasing complexity, supporting again HOR benefits on F-BEVAR short-term clinical outcomes

To our knowledge, no study has yet investigated the potential effect of modern HOR on the long-term clinical outcomes following F-BEVAR. In our experience, long-term outcomes were improved in the HOR group, with statistically significant decreases in reintervention rates and graft instability in the complex F-BEVAR subgroup. These results support the assumption that hybrid rooms have the potential to not only improve procedural and short-term outcomes, but also possibly long-term clinical outcomes. Inclusion was stopped in 2014 in order to have 5-year follow-up for all included patients.

CBCT plays probably a major role. Several studies have investigated the impact of CBCT after F-BEVAR.^1–3,9,15 They have reported that endoleaks and kinking were detected intraoperatively with a better sensitivity than with 2D completion angiograms, possibly leading to immediate correction and reduction of early reintervention rate. According to Tenorio et al,⁹ up to 1 of 5 patients could have positive findings leading to a prompt revision after CBCT, especially after F-BEVAR. In a previously published study,¹ we identified that one third of the patients treated with standard or complex EVAR between 2013 and 2014 had an additional endovascular revision during the index procedure following the CBCT. We thus strongly recommend the routine use of CBCT, especially when performing complex F-BEVAR.

Study Limitations

The main limitation of this study is that it is retrospective and compares two consecutive groups of patients. Short- and long-term results of a new complex surgical technique, such as F-BEVAR, should improve overtime thanks to the learning curve. In order to partly compensate for this potential bias, we excluded from the study all patients treated from 2004 to 2010, when less than 30 complex F-BEVARs were performed each year (Figure 1). Finally, preoperative anatomical details of the target vessels were not included in our analysis. This could also have influenced the results, although the number of patients included should limit its impact.

Conclusions

While confirming that F-BEVAR performed in a HOR equipped with advanced imaging is associated with better procedural and short-term outcomes, this study demonstrates potential clinical long-term benefits, especially for complex F-BEVARs with 3 or more fenestrations and/or branches.

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: SH is a consultant for Cook Medical, and GE Healthcare. AH is a consultant for GE Healthcare and Medtronic. GT is a consultant for Medtronic. GLDT has received consultancy fees from Amgen for methodological support outside the scope of this project.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iDs

Giovanni Tinelli

Adrien Hertault

Simona Sica

Stéphan Haulon

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