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

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).

留言 (0)

沒有登入
gif