Two-year single centre results with covered endovascular reconstruction of aortic bifurcation (CERAB) in the treatment of extensive aorto-iliac occlusive disease

Abstract

Objective

To report the results of a single-centre in the treatment of extensive aorto-iliac occlusive disease (AIOD) by the covered endovascular reconstruction of aortic bifurcation (CERAB) technique.

Methods

A retrospective analysis was conducted on data obtained from the review of medical charts of all consecutive patients treated with CERAB technique for AIOD between January 2016 and December 2019 in San Giovanni-Addolorata Hospital (Rome, Italy). Clinical examination, duplex ultrasound with ankle-brachial index measurement and contrast-enhanced computed tomography angiography were performed preoperatively. A clinical and ultrasound follow-up was carried out at one month and then half yearly after the intervention to evaluate patients’ clinical status, limb salvage, target lesion revascularization rate, primary and secondary patency rate.

Results

During the study period, 24 patients (14 men, 58.3%; 10 women, 41.7%; median age 59 years, range 37–79 years) underwent CERAB for AIOD (TASC II C 29.2%, TASC II D 70.8%). Indications for treatment were: intermittent claudication in 18 patients (75%) and critical limb ischemia in 6 (25%). Technical success was achieved in all cases. Perioperative minor complications occurred in three cases (12.5%). One patient reported an intraoperative iliac rupture requiring adjunctive covered stenting. Median hospital length of stay was two days (range 1–9). No patient died perioperatively nor at the last follow-up. At a median follow-up of 18 months (range 6–48 months), mean ankle-brachial index increased significantly (from 0.62 ± 0.15 before the procedure to 0.84 ± 0.18) (P < 0.001) and target lesion revascularization rate was 12.5%. At two years, the limb salvage rate was 100%, and primary and secondary patency rates were 87.5% and 100%, respectively.

Conclusion

CERAB technique demonstrated to be effective at the mid-term follow-up with low rate of complications and short length of stay. Long-term results and more robust data are needed to affirm this technique as the first-line treatment for extensive AIOD. However, it could become the preferred option especially in fragile patients and during contemporary COVID-19 pandemic due to the current limitations in vascular and critical care bed capacity.

Keywords

Aorto-iliac occlusive disease aorto-iliac occlusion Leriche syndrome CERAB Covid-19 pandemic

Introduction

Surgical revascularisation has been traditionally preferred to endovascular procedures in the treatment of extensive aorto-iliac occlusive disease (AIOD) responsible for disabling lower limb claudication and critical ischemia.¹

TASC II (Trans-Atlantic Inter-Society Consensus)¹ C and D lesions have been normally managed by traditional open surgery, while endovascular approach (i.e. the kissing stents technique) has been performed for less complex lesions. However, over the last years, the covered endovascular reconstruction of the aortic bifurcation (CERAB) technique has emerged as a valuable alternative in management of AIOD.^2–5

Specifically, the CERAB mimics the anatomy and physiology of the aortic bifurcation by the means of covered stents overcoming the disadvantages of kissing stents such as flow turbulence and blood stasis that might represent underlining causes of thrombus formation and intimal hyperplasia.^6,7

According to previous studies, this endovascular reconstruction guarantees satisfactory results with a primary and secondary patency rates up to of 87% and 95%, respectively, at two-year follow-up.⁵ Moreover, this endovascular approach seems to be more suitable if compared to open repair to treat AIOD in high-risk patients, because it is associated with lower complications rate. Additionally, two aspects of this approach should not be underestimated during current COVID-19 pandemic: CERAB may be performed without need for critical care bed and guarantees shorter length of hospital stay.^8,9

In the present study, we report the results achieved with the CERAB technique in the treatment of TASC II C-D AIOD in term of technical success, limb salvage, target lesion revascularization, primary and secondary patency rate at the mid-term follow-up at our Institution.

This study followed the principles outlined in the Declaration of Helsinki. It is not classified as a research requiring formal ethics approval according to Italian Law. Written informed consent was obtained from patients for publication of their data and accompanying images.

Methods

Study design, population and data collection

A retrospective analysis was conducted on data obtained from the review of medical charts of all consecutive patients treated for critical limb ischemia (CLI) or disabling lower limbs claudication (Rutherford classes 3–6) in the Vascular and Endovascular Unit of San Giovanni-Addolorata Hospital, Rome (Italy), between January 2016 and December 2019.

Only patients affected with extensive AIOD (TASC II C-D lesions)¹ and have undergone CERAB technique were included.

Indication for CERAB technique included a poor operative risk in patients unfit for open surgery (taking into account the ASA score, the presence and severity of coronary artery disease and chronic obstructive pulmonary disease) or patients’ preferences when they refused major surgery. CERAB technique was preferred over Kissing Stent whenever the lateral wall of the distal aorta presented with plaque and the treatment of the target lesions required a protrusion of iliac stents >20 mm into the aorta.

CERAB was performed only in the absence of aortic aneurism or dilation.

Patients treated with surgical revascularization or best medical treatment (exercise and pharmacotherapy) were excluded from the analysis.

Follow-up schedule consisted in clinical and instrumental evaluation at one month and half yearly after the intervention in order to assess patient’s symptoms and vessels’ status.

Clinical assessment and preoperative management

Patients’ preoperative assessment consisted in clinical examination performed by an expert vascular surgeon, duplex ultrasound (US) with ankle-brachial index (ABI) measurement and contrast-enhanced computed tomography angiography (CTA).

The diagnosis and the evaluation of the severity of the vascular disease were made according to the following criteria: (a) presence of lifestyle-limiting disability due to intermittent claudication unresponsive to exercise or pharmacotherapy within unless three months or rest pain or tissue loss (ulcer or gangrene) for more than two weeks (Rutherford classes 3–6); (b) presence of underling arterial lesions at the US and CTA imaging; (c) ABI at dorsalis pedis or posterior tibial artery between 0.9 and 0.4.

The severity of the arterial disease was defined according to TASC II classification.¹

Preoperatively, all patients benefited from the optimization of medical treatment by the instauration of antiplatelet (75 mg of clopidogrel or 100 mg acetylsalicylic Acid) and statin therapies.

Outcomes measurement and statistical analysis

Primary endpoints were the immediate technical success, limb salvage rate and primary and secondary patency. The ABI improvement at the long-term follow-up and the target lesion revascularization (TLR) rate were also evaluated.

Technical success was defined as the successful re-entry in the arterial lumen in absence of distal dissection, the correct stent placement with restoration of blood flow, the absence of stent kinking and a residual stenosis lesser than 30%.

TLR was defined as any repeat percutaneous intervention of the target lesion or of the target vessel performed for restenosis or other complication of the target lesion during follow-up period.

Primary patency was defined as the duration of CERAB revascularization patency without any re-operation; assisted-primary patency was defined as the patency of the revascularization achieved with additional/secondary surgical or endovascular procedure if the occlusion of the target vessel was not occurred and secondary patency as the duration of patency after successful re-intervention.

Secondary endpoints were death rate and both local (groin hematomas, false aneurysm formation, local infection, distal embolism, arterial rupture and erectile dysfunction) and systemic complications (myocardial infarction, stroke, renal insufficiency and pneumonia).

Data were collected in an electronic database and analysed with statistical software (IBM SPSS Statistics 22). The data are reported in percentages and absolute values. Continuous variables are expressed in the mean or in the median of the values obtained. Primary and secondary patency rates were calculated on the basis of the “first event” (arterial re-stenosis, occlusion or re-intervention) after the CERAB procedure by the Kaplan-Meier analysis. Means were compared using a t-test and P-value <0.05 was considered significant.

Procedure

Every procedure was carried out in the operative room with the aid of the latest generation mobile C-arm angiography equipment (Ziehm Imaging GmbH, Nuremberg, Germany). Procedures were performed under general or local anaesthesia through a bilateral percutaneous femoral approach with the adjunct of brachial access in selected cases.

Surgery was performed in all patients by two expert and specifically trained surgeons of our team using the same technique and indication for treatment.

All patients received 100 units of heparin/Kg intra-operatively.

Firstly, a short 6–7 Fr sheath was placed over a 0.035 wire in the femoral arteries bilaterally.

Recanalization was performed intra-luminally in most of the cases and when needed we proceeded sub-intimally using a 0.018 guide wire. In selected cases, Outback Elite (Cordis, Hialeah, FL) re-entry catheter was used to regain the true lumen.

For anterograde recanalization, an additional brachial access was percutaneously achieved through a 90 cm long 6 Fr sheath and the lesion was thus approached from the both ends.

In lesions extending up to renal arteries, these vessels were previously identified and cannulated from the brachial access, and an extra dose of heparin was administrated to avoid thrombus propagation and limit embolization risks.

The achievement of the correct channel was verified with BER II catheter and angiography with small amount of iodinated contrast. Angioplasty was performed with 5 mm balloon, and thereafter an appropriately sized aortic stent was deployed in distal aorta (12–14 mm diameter covered balloon-expandable stent, BeGraft, Bentley, Hechingen, Germany) approximately 20 mm above the bifurcation through the sheath placed in the side that was most difficult to re-canalize and maintaining the contralateral iliac sheath at the level of the common iliac ostium. The aortic stent was then molded with short semi-compliant balloons to assure optimal aortic wall apposition.

Thereafter the iliac stent (8–10-mm in diameter) were positioned in a kissing conformation, overlapping with the aortic stent for 10–15 mm. Then ballooning with two kissing compliant balloons was performed to adapt the parallel stents to the aortic one.

Both self-expandable and balloon expandable covered stents were implanted (Viabahn VBX, W. L. Gore and Associates, Flagstaff, Ariz or Atrium’s Advanta™ V12, Maquet, Rastatt, Germany). Completion angiography was performed at the end of the procedure to verify the correct deployment of the stents, the apposition of the kissing stents to the aortic one, the patency of renal arteries and CERAB reconstruction.

After the removal of catheters and sheaths, a closure device (Angioseal, Terumo) was used to close the arteriotomy site in the common femoral artery.

Postoperatively, patients were treated with dual antiplatelet therapy, including Clopidogrel during the first six months and acetylsalicylic acid lifelong. Patients already treated with anti-coagulants for other reasons underwent acetylsalicylic acid lifelong treatment only.

Figures 1 and 2 show the intraoperative arteriography and postoperative CTA results in a patient treated at our Institution.

Figure 1.

Volume rendering of preoperative computed tomography angiography (a) and intraoperative angiography (b) the occlusion of distal aorta and common iliac arteries bilaterally.

Figure 2.

(a) Intraoperative completion angiogram showing the successful revascularization of aortic bifurcation and iliac axis with CERAB technique. (b) Volume rendering reconstruction of the one-month computed tomography angiography control confirming the patency of the aorto-iliac revascularization.

Results

During the study period, a total of 66 patients with TASC-II D AIOD lesions who underwent revascularization at our institute were retrospectively included. Four underwent open revascularization, 38 underwent kissing stent procedures and 24 patients (14 men, 58.3%; 10 women, 41.7%; median age 59 years, range 37–79 years) underwent CERAB. Indications for treatment were intermittent claudication in 18 (75%) and critical limb ischemia in 6 (25%) patients. Preoperative CTA showed in 29.2% (n = 7) of cases TASC II C and in 70.8% (n = 17) of cases TASC II D lesions.

Demographic data, comorbidities and ASA (American Anaesthesiologist physical Status classification) are reported in Table 1.

Table 1.

Baseline and preoperative data.

Demographics data	n patients (total 24)	%
Age (years)	59 (range 37–79)
Gender	10 women14 men	41.758.3
Hypertension	23	96
Diabetes mellitus	9	37.5
CAD	13	35.1
Body mass index >25 kg/m²	4	16.7
Dyslipidaemia	21	87.5
Smoking habits (current)	20	83.3
COPD	14	58.3
CKD (documented pre-dialysis or on dialysis)	–	–
Clinical presentation
Disabling claudication	18	75
Critical limb ischemia	6	25
Mean ABI	0.62 ± 0.15
TASC II classification
TASC II C	7	29.2
TASC II D	17	70.8
CTO	3	12.5
ASA class
Class 1	–	–
Class 2	8	33.3
Class 3	11	45.8
Class 4	5	20.9

CAD: coronary artery disease; COPD: chronic obstructive pulmonary disease; CKD: chronic kidney disease; ABI: ankle brachial index; TASC: Trans-Atlantic Inter-Society Consensus classification; CTO: chronic total occlusion; ASA: American Anaesthesiologist physical status classification.

Most procedures were performed under local anaesthesia (n = 17, 70.8%). General anaesthesia was needed in seven patients (29.2%). All procedures were performed percutaneously by a bilateral femoral approach. An additional brachial access was achieved in three cases (12.5%).

Immediate technical success was achieved in all cases (n = 24, 100%) without any distal dissection, stent kinking or significant residual stenosis detected in any cases. One patient (4.2%) experienced an intra-procedural rupture of the common iliac artery. He was treated by covered stenting in the same procedure without any sequelae.

Perioperative minor complications occurred in three patients (12.5%) who reported groin hematoma managed conservatively.

The median hospital length of stay was two days (range 1–9 days).

No deaths, cardiovascular events or other complications during in-hospital period, at 30-day and at the mid-term follow-up were reported (Table 2).

Table 2.

Procedural data and postoperative outcomes.

Type of anaesthesia	n patients (Total 24)	%
Local	17	70.8
General	7	29.2
Surgical approach		%
Percutaneous	24	100
Surgical	–	–
Bilateral femoral	24	100
Femoral and brachial	3	12.5
Technical success rate	24	100
In-hospital clinical outcomes	n patients (Total 24)	%
Overall mortality	–	–
Stroke /MI/renal insufficiency/pneumonia	–	–
Local complications
• Groin hematoma	3	12.5
• Arterial rupture	1	4.2
• Distal embolism/false aneurysm/local infection/erectile dysfunction	–	–
Median hospital length of stay	2 days (range 1–9 days)
Outcomes during follow-up	n patients	%
Limb salvage for CLI	6	100
Primary patency	21	87.5
Secondary patency	24	100
TLR	3	12.5
Mean ABI	0.84 ± 0.18

CLI: critical limb ischemia; ABI: ankle-brachial index; MI: myocardial infarction; TLR: target lesion revascularization.

There was no thrombosis or significant arterial restenosis at the early postoperative follow-up visit.

At a median follow-up of 18 months (range 6–48 months), mean ABI increased significantly (from 0.62 ± 0.15 before the procedure to 0.84 ± 0.18) (P < 0.001) and target lesion revascularization was 12.5%. A total of three patients needed repeated percutaneous intervention of the target lesion due to symptomatic pre-occlusive restenosis occurring during the follow-up period. Secondary interventions consisted in repeated iliac angioplasty and re-stenting by the mean of BMS in all of them. No major or minor amputations were reported.

At two years, the limb salvage rate was 100%; the primary, primary assisted and the secondary patency were 87.5%, 87.5% and 100%, respectively (Figure 3).

Figure 3.

Kaplan Meier estimate showing the primary, primary assisted and secondary patency of CERAB reconstruction in the population in analysis.

Discussion

In treatment of extensive aorto-iliac occlusions, the conventional surgical reconstruction has been for long considered the gold standard, whereas the endovascular revascularization has been carried out only in the case of less complex lesions.^1,10,11

Reported patency rates of open surgery are about 75–80% at 10 years with secondary patency rates of 80–98%. These results have still not been equalled by endovascular techniques.^12–14 However, iliac artery angioplasty and stenting has demonstrated high patency rate, and over the time, the number of aorto-bifemoral grafts performed has progressively decrease.^15,16

Over the last decades, endovascular procedures have been widespread performed and the improvement in techniques and materials has led to extend this approach also to the treatment of TASC II C-D lesions.² In fact, even though no data from randomized trials are nowadays at disposal, previous reports stated that because endovascular treatment lowers complications rate, shortens the hospitalization time and decreases hospital costs in respect to open surgery, it could be particularly indicated for patients older than 80 years.⁸

Thereafter, several studies have reported encouraging data with low rate of perioperative morbidity in respect to surgery.^5,14,17 More specifically, the CERAB technique is increasingly considered as a valuable alternative to traditional surgery because it is safe, much less invasive and its results are promising. Accordingly, in this series, we did not report any major systemic complication and only three patients presented with local complication managed conservatively; we remarked an overall significant improvement of the ABI, and limb salvage was achieved in all patients presenting with critical limb ischemia. Moreover, as already reported by Grimme et al.,⁵ CERAB guarantees a primary patency rate of 87.3% and 82.3% at one year and two years, respectively, and a secondary patency of 95% at two years as similarly occurred in this series. Additionally, a recent report by McElligott et al. has also underlined the value of this endovascular therapy in reducing the impact of vascular surgery on intensive care capacity during the current critical period of COVID-19 pandemic.⁹

Either way, when compared with other endovascular techniques, CERAB better mimics the aortic bifurcation’s anatomy and physiology possibly improving the overall patency.⁶,⁷ In CERAB, the occlusion of the revascularization at the long-term seems to be linked to stent collapse or kinking and it is probably the results of the progressive evolution of the inflow or outflow obstruction.⁴,¹⁸,¹⁹ In this scenario, in our experience, we proceeded covering the entire length of the diseased area using as landing zone for the stents the healthy portion of both aorta proximally and iliac arteries distally. With this regard, some authors have evocated the possibility to use chimney grafts (C-CERAB) if renal or visceral arteries are involved in the proximal aortic target segment.⁵ Furthermore, since anti-platelet therapy has shown to be fundamental in previous experience with iliac stenting and other endovascular revascularization of peripheral lesions, we elected to keep all patients of this series under dual anti-aggregation during the first six months in order to prolong patency over the time.

From a technical standpoint, CERAB can be challenging: often multiple access sites are required and the revascularization may be performed intra-luminally, but most of the time, it needs to be carried out sub-intimally. In our experience, we used both approaches and we were able to achieve the re-entry in the arterial lumen in all cases. In fact, we planned the procedures in accord to the pattern of aortic lesions to be treated: we mostly performed the interventions trough a bilateral percutaneous femoral approach, but we elected to add a brachial access in selected cases in order to always be able to regain the arterial lumen when proceeding sub-intimally.

Another important aspect to underline is that treating surgeons must be aware that thrombus might dislodge into the renal arteries during treatment of juxta-renal aorto-iliac occlusions or in patients with a distance shorter than 2 cm between the ostium of the renal arteries and the beginning of the arterial lesion.²⁰,²¹ In this perspective, in our experience, we elected to administrate an extra dose of heparin and to use as protective measures the preventive positioning of two guidewire in renal arteries through the brachial access in order to be able to perform prompt angioplasty and stenting when needed, as previously described.²¹

In treatment TASC II C-D AIOD, both bare metal and covered stents may be used according to the lesion encountered. Zhang et al. have recently reported satisfactory results with BMS at three-year follow-up with one-, two- and three-year primary restenosis-free survival rates of 94.4%, 88.1% and 73.5%, respectively, and secondary patency rates of 94.4%, 94.4% and 86.6%, respectively.²² However, the presence of immature mesenchymal tissue, intimal hyperplasia and organized thrombus in the space between the opposing BMS, within the lumen of the stents and at the level of the free floating intra-aortic portion of the devices have been described.²³,²⁴ In this perspective, the results from the Covered versus Balloon Expandable Stent Trial (COBEST) outline the benefits of stent grafts that may prevent the adverse pathological changes encountered with BMS.²⁵ With that regard, a previous study reported a primary, primary assisted and secondary patency of 86%, 91% and 97% at one year; 84%, 89% and 97% at two years; and 82%, 87% and 97% at three years with the CERAB technique.²⁶ Additionally, during the procedure dissection, perforation or embolization may be encountered, so the use of covered stents can immediately treat these complications reducing morbidity and mortality.

In this series, the mean ABI significantly increased from 0.62 ± 0.15 before the procedure to 0.84 ± 0.18 during follow-up. Although this improvement was statistically significant, Taeymans et al. previously reported even more satisfactory results. Actually, however, this group described the results achieved in treatment of a population of patients affected with lesions more severe (89% of cases presented with TASC II D lesions) than those we treated (70.8% of TASC II D lesion) probably influencing the reported outcomes.²⁶

In summary, the CERAB and C-CERAB techniques have shown to guarantee remarkable clinical results and patency rates in the mid-term follow-up with a low rate of complications and a short duration of hospital stay. Nevertheless, some limitation of CERAB technique must be underlined. For instance, this approach involves a major sacrifice of collateral bowel circulation because of the deployment of the aortic stent grafts. Furthermore, when compared with the kissing stent technique, CERAB is more expensive and more difficult to perform. Finally, the flaring technique of stents with used with extension in the aortic bifurcation is still out-of-the-instruction for use.²⁷

Conclusion

In our experience, CERAB has shown to be a safe and effective option for treating patients with extensive AIOD. We suggest that this technique could become in the foreseeable future the preferred treatment option for fragile patients and during contemporary COVID-19 pandemic taking into account the current difficulty in delivery vascular care and the limitations in critical care bed capacity. However, comparative randomized studies with the surgical current gold standard are indicated in order to analyse the long-term outcomes and affirm this technique as the first-line treatment.

Limits

Our study has some limitations. It was a retrospective single-centre cohort study with small sample size, so our results are likely to be affected by selection bias. Moreover, no comparative group with conventional surgical treatment was evaluated.

Footnotes

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

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

ORCID iD

Ottavia Borghese

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