Prospective evaluation of automated vascular analysis for ilio-femoral artery lesions before and after percutaneous endovascular aortic repair

Abstract

Background

This study was conducted to evaluate the differences between pre- and postoperative access conditions in percutaneous endovascular aortic repair (PEVAR).

Methods

Between December 2021 and October 2023, PEVAR was performed on 61 patients using the Perclose ProStyle (Abbott Vascular). Enhanced computed tomography and ankle-brachial index tests were performed preoperatively and postoperatively. The inner diameter and area of the iliofemoral artery were automatically measured, and the pre- and postoperative values were compared (114 legs). The same analysis was performed on 12 legs with previous groin operations; open surgical EVAR was performed in 9 legs, an endarterectomy of the femoral artery in 1, and a femoropopliteal bypass in the other leg.

Results

All patients were discharged without surgical site infections, lymphatic fistulas, or retroperitoneal haematomas. There were no significant differences between the pre-and postoperative inner diameter and inner area of the external iliac artery and common femoral artery. There were no significant differences between the preoperative and postoperative ankle-brachial index tests. In 12 legs with a previous groin operation, the postoperative ankle-brachial index tests and inner diameter and area of the external iliac artery and common femoral artery were statistically equal to the preoperative values.

Conclusions

This study can support the safety of percutaneous endovascular aortic repair, even in patients with redo groin operations.

Introduction

Endovascular aortic repair (EVAR) is the first-line surgical option for abdominal aortic aneurysms (AAA) and common and internal iliac artery aneurysms (CIAA and IIAA) worldwide, particularly for older or high-risk patients who are not good candidates for conventional open surgery [1,2,3]. Percutaneous EVAR (PEVAR) using suture-mediated closure devices has the advantage of lower invasiveness than conventional EVAR, and it has been gaining attention as an alternative. Many studies have reported advantages of PEVAR, such as its shorter surgery times and hospital stays compared with conventional EVAR [4,5,6] Access issues are among the most common complications associated with EVAR [7] and PEVAR [8]. Several studies have reported access complications associated with these closure devices [8,9,10].

Replicable measurement of the iliofemoral artery is essential for precisely evaluating the influence of PEVAR on access status. SYNAPSE Vincent (Ver 4.1, Fujifilm Co., Tokyo, Japan) is a computed tomography (CT) workstation software that can automatically calculate the inner or outer diameters and the areas at every point of the ilio-femoral artery. It can help avoid operator bias in the measurement of iliofemoral parameters, and the workstation has already been used in clinical studies associated with the quantitative evaluation of atheromatous changes of the shaggy aorta [11].

Therefore, this study aimed to evaluate the differences between pre- and postoperative access conditions at the iliofemoral artery in PEVAR, including those with redo groin operations, using automated calculation of the ilio-femoral artery parameters [Supplemental Figure 1].

Materials and methods

Patient recruitment

This prospective study was conducted in December 2021. Until October 2023, EVAR had been performed in 62 consecutive patients with degenerative aortic aneurysms. One patient was excluded from the study because surgical EVAR was performed due to a common femoral artery (CFA) diameter < 5.0 mm, which contraindicates Perclose use. Finally, 61 patients were enrolled in this study. The median patient age (with interquartile ranges [IQRs]) was 82.0 (79.0–85.0) years old (54 men, 7 women). The characteristics of the enrolled patients are summarised in Table 1.

Table 1 Patient characteristics

Regarding the location of the aortic aneurysm, 36 patients had AAA without iliac artery aneurysms, 13 had CIAA or IIAA, and 12 had AAA and CIAA or IIAA. In 1 patient with a unilateral CIAA, EVAR was performed via the same side of the CFA, and Perclose was used on only one side. The cut-down approach was electively performed in seven legs because the percutaneous approach was contraindicated in the following patients: 6 patients with unilateral short CFA (length < 20 mm) and higher bifurcation, and 1 patient with a proximal anastomosis of the femoropopliteal bypass on the front of the CFA. These 8 legs were excluded, and the study was conducted with data from 114 legs using the percutaneous approach in EVAR.

The details of the sheath sizes are listed in Table 2. Most of the sheaths used were 12 Fr sheath (n = 38), with sheath sizes ranging from 8 to 20 Fr. For details of the EVAR devices, we implanted 43 commercially available stent grafts as follows: 46 Excluder stent grafts (W. L. Gore and Associates, Inc., Flagstaff, AZ, USA), 8 Endurant-II stent grafts (Medtronic Inc., Santa Rosa, CA, USA), 5 AFX2 stent grafts (Endologix Inc., Irvine, CA, USA), and 2 Aorfix endografts (Lombard Medical, Oxon, UK).

Table 2 Postoperative outcomes

Five patients required Chimney EVAR with the reconstruction of some visceral branch arteries for juxtarenal or suprarenal AAA; 2 underwent reconstruction of the superior mesenteric artery (SMA) and bilateral renal arteries (RAs), 2 underwent reconstruction of the unilateral RA and 1 of the SMA and unilateral RA. The visceral branch artery was reconstructed using a VIABAHN (W. L. Gore and Associates, Inc.), inserted via the subclavian artery as previously described [12].

Protocol of the PEVAR procedure

Under general anaesthesia, PEVAR was performed in the operating room using C-arm fluoroscopy. Using a combination of ultrasonographic and fluoroscopic guidance, an 8-Fr sheath was inserted bilaterally into the CFA. A 0.035-inch guidewire was advanced over the terminal aorta, and a Perclose ProStyle (Abbott Vascular, Redwood Shores, CA, USA) was inserted along the wire after removing the sheath. Subsequently, a set of sutures was deployed before EVAR. As for the number of closure devices used, one device is usually used for an 8-Fr sheath, and two devices are used for a 12-Fr sheath. After reinserting the 8Fr sheaths, EVAR was performed as usual.

After EVAR, the sheaths were removed, leaving a guidewire through the CFAs. While one operator manually compressed the puncture site, the other tightened the knot using a knot pusher. The wire was removed immediately after haemostasis was achieved, and manual compression of the puncture site was continued for 15 min. If active bleeding was found after removal of the sheath with retaining the guidewire, an 8-Fr sheath was inserted again along the wire, and the puncture site was subsequently surgically closed on the exposed CFA.

Study protocol

This study was approved by the ethics committee of Toyonaka Municipal Hospital. Written and verbal informed consent was obtained from all enrolled patients. For all enrolled patients, enhanced CT and ankle-brachial index (ABI) tests were performed within 2 months before and within 1 week after the PEVAR procedures. Based on preoperative and postoperative CT data, we measured the inner or outer diameters and areas of the iliofemoral artery using SYNAPSE Vincent (ver 4.1, Fujifilm Co.). The proximal and distal ends of the CFA were defined as the CFA just under a branch of the inferior epigastric artery and the CFA bifurcation, respectively. These parameters were measured at the orifice of the external iliac artery (EIA) and at the midposition, proximal and distal ends of the CFA. These parameters and the ABI were compared pre- and postoperatively to evaluate whether these influence the suitability of PEVAR for the ilio-femoral artery. The same analysis was performed on 12 legs that had undergone a previous groin operation.

Enhanced CT protocol

All enrolled patients underwent whole-body enhanced CT using a 64-detector CT scanner (Revolution GSI, GE Health Care Japan, Tokyo, Japan). Quantitative measurements of the inner or outer diameters and areas in the iliofemoral artery were performed using CT data with a protocol that used commercial software (SYNAPSE Vincent), an established modality for calculating the diameters of the aorta and iliofemoral artery [11]. In total, 30 s after the intravenous administration of 75–100 mL contrast agent at approximately 3 mL/s, CT was performed. Early arterial phase data with a slice thickness of 1.25 mm were transferred to the 3D image analysis workstation. A central luminal line of the iliofemoral artery was automatically defined, and multiplanar reconstruction images were obtained perpendicular to the midline with a regular slice thickness. In each MPR image, the contour of the iliofemoral artery lumen was automatically recognised and traced. Eventually, the inner or outer diameters and areas were automatically calculated to avoid operator bias in measuring the iliofemoral parameters. For all patients, these data were reviewed by another cardiovascular surgeon.

Statistical analysis

Comparisons between pre- and postoperative diameters and areas of the EIA and CFA were performed using the Wilcoxon signed-rank test and are expressed as medians with IQRs. We defined p < 0.05 as statistically significant. All statistical analyses were performed using JMP Pro 17.0.0 (SAS Institute, Inc., Cary, NC, USA).

Results

Postoperative outcomes

Details of the postoperative outcomes are listed in Table 2. Procedural success was achieved in all 61 patients, with a median operative time (IQRs) of 104 (86–133) minutes. Any additional closure devices had not been used in any of the enrolled cases. All patients were extubated in the operating room. Both 30-day and inpatient mortality rates were 0%. Neurological deterioration, such as cerebral stroke or ischemic spinal injury, did not occur in any patient. Regarding representative complications around the puncture site, surgical site infection (SSI), lymphocele, CFA pseudoaneurysm, and retroperitoneal haematoma (RPH) were not observed in any patient. In 1 patient (1.6%), the bilateral CFAs were less palpable, eventually requiring an endarterectomy with a “patch plasty.” Postoperative enhanced CT showed no type Ia/Ib endoleakage (EL) in any enrolled patient. Follow-up was uneventful, and patients were discharged on the sixth postoperative day. Type II EL was detected in 11 patients (18.0%). At the time of writing, significant aneurysm enlargement had not been observed.

Access status of the iliofemoral artery after PEVAR

The pre- and postoperative diameters and areas of the iliofemoral arteries are presented in Table 3. The postoperative inner diameter and the areas of EIA were maintained as statistically equal as preoperatively (median [IQR] pre- vs. postoperative: 8.90 [7.94–10.01] vs. 8.84 [7.84–9.72] mm, and 65.30 [54.20–82.30] vs. 63.83 [50.05–78.46] mm², p = 0.262, 0.121, respectively). Concerning the inner diameter of CFA at each point, there were no significant differences between the preoperative and postoperative values (proximal CFA; 7.86 [7.09–8.58] vs. 7.88 [7.09–8.63] mm, p = 0.229, CFA mid; 8.54 [7.76–9.38] vs. 8.56 [7.91–9.44] mm, p = 0.434, and distal CFA; 8.08 [7.34–9.24] vs. 8.13 [7.51–9.26] mm, p = 0.163). The inner area of the CFA at each point showed no significant differences pre- and postoperatively (proximal CFA; 50.82 [41.06–59.83] vs. 51.34 [41.73–60.81] mm², p = 0.203, CFA mid; 59.09 [48.75–72.30] vs. 60.03 [52.00–72.94] mm², p = 0.824, and distal CFA; 53.51 [45.28–69.77] vs. 54.31 [46.35–70.01] mm², p = 0.413). Regarding the ABI and systolic blood pressure of the lower leg, there were no significant differences between pre- and postoperative values (ABI; 1.13 [1.04–1.21] vs. 1.13 [1.07–1.19], p = 0.208; lower leg systolic blood pressure of the lower leg: 149 [132–172] vs. 152 [138–169] mmHg, p = 0.905) (Fig. 1).

Table 3 Pre- and postoperative diameters and areas of the iliofemoral artery in PEVAR

Fig. 1

Pre- and postoperative inner diameters and areas of iliofemoral in PEVAR

Access status of the iliofemoral artery after PEVAR on those with previous groin operation

In total, 12 of the 114 legs had previously undergone surgical procedures with groin cut-down as follows: EVAR was performed for 9 legs, an endarterectomy of the CFA for 1, and a femoropopliteal bypass for the other leg. Details of the sheath sizes used are listed in Table 2. All patients were uneventfully discharged, with a median postoperative day of 5 days.

Preoperative and postoperative inner diameter and area of EIA showed no statistical differences (9.60 [8.74–10.85] vs. 8.81 [8.79–10.72] mm, p = 0.086, 75.31 [63.01–88.75] vs. 63.30 [62.90–93.15] mm², p = 0.129, respectively). Regarding the inner diameter and area of CFA, there were no significant differences pre- and postoperatively (proximal CFA; 8.29 [7.88–8.72] vs. 8.63 [8.10–9.09] mm and 55.81 [50.45–61.72] vs. 60.45 [53.16–67.03] mm², p = 0.844, 0.910, respectively; CFA mid; 9.66 [8.17–10.65] vs. 10.09 [8.34–10.51] mm and 76.12 [54.17–92.26] vs. 82.95 [56.48–89.54] mm², p = 0.438, 0.426, respectively; distal CFA; 10.06 [8.17–10.83] vs. 9.52 [9.22–10.76] mm and 82.62 [54.33–95.31] vs. 76.67 [69.29–94.07] mm², p = 0.098, 0.129, respectively).

Discussion

We demonstrated that the postoperative access status at the iliofemoral artery was preserved at a size similar to that preoperatively. Additionally, we confirmed that the same trend was observed even in patients who underwent a repeat groin operation.

Several randomised controlled trials have recently revealed a high aneurysm-related reintervention rate after EVAR during long-term follow-up [13, 14]. Endoleakage is one of the primary causes of reintervention after EVAR [15]. Since redo open graft replacement is usually contraindicated in these patients owing to their poor backgrounds, redo EVAR for type I/III EL and coil embolisation of the feeder arteries, such as the inferior mesenteric artery or lumbar artery for type II EL, are important surgical options [15,16,17]. The iliofemoral artery with a previous groin operation is an important access site in such cases.

Regarding representative complications after EVAR, such as SSI and lymphocele [18], the occurrence of these complications in those who underwent repeat groin surgery could generally exceed that in those who underwent initial EVAR. These complications can prolong the postoperative hospital stay, leading to poorer activities of daily living and quality of life. In the present study, these complications were not observed in any enrolled patients, similar to several previous studies, [4,5,6] and were the same even in those who underwent repeat groin operations. Our study supports the usefulness and feasibility of PEVAR for repeat groin operations. Some patients have a large enough proximal SFA diameter to use Perclose. A recent study reported that ultrasound-guided SFA using a closure device was a safe alternative with an acceptable rate of complications [19]. PEVAR via the proximal SFA may be an option, particularly in cases with limitations.

We experienced 1 patient with significant stenosis of the left EIA and right CFA after PEVAR for the right CIAA with 12- and 8-Fr sheaths through the right and left CFA. In retrospect, on the basis of preoperative findings, the close use of a hostile CFA with severe serial calcification along the lateral wall, not only the anterior wall [20, 21], should be carefully discussed. Alternatively, PEVAR through the proximal SFA might be possible and realistic, particularly in patients with high bifurcation of the CFA [19].

The present results should be interpreted carefully because of some limitations, including the small number of enrolled patients. In particular, this analysis of PEVAR with repeat groin operations may not have been sufficiently powered. In addition, it is necessary to evaluate the long-term status of the ilio-femoral artery. Follow-up CT is usually performed within 1 week postoperatively and again at 3, 6, and 12 months postoperatively. In patients with no sac enlargement in the first postoperative year, CT can be performed annually. Consider the present findings, this topic should be further investigated in larger samples with long-term follow-up in future studies.

Conclusion

The preoperative and postoperative inner diameters and inner areas of the CFA and EIA were not statistically different in all enrolled patients, including those who underwent repeat groin operations. The present study might support PEVAR safety even for patients with repeat groin operations, leading to improved postoperative outcomes and decreased complications around the groin scar in such patients.