Early Experience of Inner Branch Retrograde Cannulation With E-nside Branch Stent Graft for Thoracoabdominal Aortic Aneurysms

Abstract

Purpose:

The aim of our study is to investigate the feasibility of retrograde cannulation using devices with inner branches (IB) for the endovascular treatment of thoracoabdominal aortic aneurysms (TAAAs).

Materials and Methods:

A retrospective analysis using IB configuration with retrograde cannulation was carried out on TAAAs patients undergoing endovascular treatment.

Results:

Seven patients underwent IB endovascular treatment with retrograde cannulation between September 2020 and November 2021. The mean age was 80.4 years and 4 patients were male. A total of 26 of 28 target vessels were cannulated by retrograde access with a technical success of 93% (2 of 26 target vessels). Two intra-procedural complications were observed (1 renal artery dissection and 1 collateral renal artery rupture). In total, 26 of 28 treated vessels were retrograde cannulated with a technical success of 93%. A total of 39 stent bridges were used (all Viabahn VBX devices). The mean duration of the procedure was 321±102 minutes, and the mean scan time was 134±62 minutes. Mortality at 30 days was observed in 1 case. During the follow-up, 1 stent bridge occlusion was observed without the need for reintervention.

Conclusion:

Retrograde cannulation can also be successfully performed in the case of inner branches.

Clinical Impact

In inner branched cases, retrograde cannulation should be taken into consideration in particular cases or it could become the option of choice. Dedicated endovascular material available such as steerable catheters and latest generation covered stents is fundamental for the success of the treatment.

Keywords

inner branch retrograde cannulation E-nside branch stent graft thoracoabdominal aortic aneurysms

Introduction

Endovascular treatment of thoracoabdominal aortic aneurysms (TAAAs) can be accomplished with off-the-shelf endoprosthesis,¹ which requires a branched graft configuration. In fact, thanks to the presence of the branches, the feasibility of the treatment can be increased without the need to align the fenestrations with the target vessels.²

One of the limitations of the use of branched devices is related to the aortic diameter. For example, if the aortic diameter is small, there is no guarantee that an adequate opening of the branch can be made. Furthermore, the maneuvers of target vessel engaging and cannulation can be difficult.

Recently, a new off-the-shelf device equipped with inner branches has been proposed³ to treat anatomies with a lower aortic diameter.⁴ This device has been engineered to facilitate branch engagement.

Indeed, the main prerogative of endovascular treatment with branched prostheses is to perform the engagement of the target vessel and the positioning of the stent bridge via axillary or subclavian access. In this context, some conditions can make treatment more complex and increase the risk of complications.⁵

To reduce the risk of complications, some authors have recently proposed retrograde cannulation of the branch passing through the iliac accesses.⁶ Literature data refer to external branches, while the experience relating to retrograde cannulation in case of inner branches is very limited.⁷

The goal of our study is to investigate the feasibility of retrograde cannulation using devices with inner branches for the endovascular treatment of TAAAs in order to propose it as a further alternative technique.

Materials and Methods

A retrospective analysis of patients suffering from TAAAs and undergoing endovascular treatment using inner branches with retrograde cannulation was performed. The following parameters were preoperatively assessed for each patient: age, sex, type of TAAAs in accordance with Crawford’s classification. The comorbidity evaluated were previous aortic repair, coronary artery disease, statin use, hypertension, smoking, chronic obstructive pulmonary disease (COPD), diabetes mellitus, baseline eGFR, dialysis, stroke or transient ischemic attack, and American Society of Anesthesiologists class. The intake of antiplatelet and anticoagulation therapy was also evaluated.

Technical success was considered as the correct placement and delivery of the stent bridge through retrograde cannulation. The average intraoperative fluoroscopic time and intervention duration were also evaluated. Furthermore, the number of adopted stent bridges, the diameter, and the length for each inner branch were also evaluated. The cannulation time of each single branch and the time necessary for the stent bridge release were monitored.

We have archived the data relating to the staged procedure and the positioning of cerebrospinal fluid drainage (CFD). The onset of intra-procedural complications such as target vessel dissection or rupture was evaluated. Mortality and major complications at 30 days (acute myocardial infarction, renal failure, spinal cord ischemia, and pulmonary complications) were also considered.

The follow-up was carried out through computed tomography angiography (CTA) examinations at 1, 6, and 12 months analyzing the patency of the stent bridge and the presence of type Ic endoleak. The average diameter of the aorta at the level of the target vessel and the distance between the origin of the target vessel and the markers of the reference inner branch were also evaluated. During the follow-up, survival rate and no need for reintervention data were also considered.

Technique

All procedures were performed in a hybrid operating room equipped with a Discovery Angiography (General Electric Healthcare, USA) and with patients being under general anesthesia. After the branched component was released, the delivery system and inner branch pre-cannulation were removed. A GORE Dryseal introducer sheath (W. L. Gore & Associates) 20 Fr or 22 Fr was advanced to the inside of the branched component from the ipsilateral side, and an 22 mm Heli FX steerable guide (Medtronic, Santa Rosa, CA, USA) was then placed coaxially. The catheter was advanced and rotated 180° until working position was reached. The Angiography was then rotated until the exit markers of the inner branch were aligned, which was subsequently cannulated with the Heli FX catheter (Figure 1). Once the inner branch was engaged, a standard Terumo guide was advanced inside the aneurysm sac, and with the help of a catheter, the target vessel was engaged. At that point, a Rosen guide was positioned inside the target vessel, and a Destination 8 or 9 Fr introducer sheath was advanced up to the inside of the target vessel. An angiography was then performed to identify the distal landing zone, and, after that, the covered stent was advanced. The introducer sheath was then retracted inside the steerable catheter. When releasing the stent bridge, attention should be paid to the overlap of the stent with the inner branch, and for this reason, before releasing the stent, the Heli FX catheter was retracted to allow for the proper inflation of the balloon (Figure 2).

Results

A total of 35 patients with TAAAs underwent endovascular treatment at our Center between September 2020 and November 2021. Off-the-shelf endoprosthesis were adopted in 16 patients. In 9 patients, an inner branch device was used (E-nside multibranch stent graft system; Jotec GmbH, Hechingen, Germany). In 7 cases out of 9, retrograde cannulation of the inner branches was adopted. These 7 cases were retrospectively included in the present study.

The patients’ mean age was 80.4 years (range: 69–88 years), and 4 patients were male. Patients had TAAAs types I, II, III, and IV in 1, 3, 1 and 2 cases, respectively. The mean aortic diameter was 64.3 mm (range: 44–84 mm). Risk factors are shown in Table 1. Six of the patients had previous aortic treatment. Of them, 2 patients had already undergone open replacement of the ascending aorta, 1 patient had already undergone open replacement of the ascending aorta with debranching of the supra-aortic trunks and thoracic endovascular treatment, 2 patients had already undergone aorto-aortic graft of the abdominal infrarenal aorta, and 1 patient had undergone endovascular treatment of abdominal aortic aneurysms.

Table 1.

Patient’s Demographics, Risk Factors, and Aneurysm Characteristics.

	N = 7
Age at treatment	80.43±7.52
Male	4 (57.1)
Previous aortic repair
No	1 (14.3)
Ascending	3 (42.9)
Open	2 (28.6)
EVAR	1 (14.3)
Coronary artery disease	2 (28.6)
Statin use	2 (28.6)
Hypertension	6 (85.7)
Smoking	3 (42.9)
COPD	3 (42.9)
Diabetes mellitus	0 (0.0)
Baseline creatinine, mg/dL	0.97 ± 0.35
Baseline eGFR, mL/min/1.73 m²	83.29 ± 25.26
Dialysis	0 (0.0)
Stroke or TIA	0 (0.0)
ASA classification
I	1 (14.3)
II	3 (42.9)
III	3 (42.9)
Antiplatelet therapy
No	3 (42.9)
Single	2 (28.6)
Dual	2 (28.6)
Anticoagulation	2 (28.6)
Largest aortic diameter, mm	64.29 ± 13.60
Crawford classification of aneurysm extension
I	1 (14.3)
II	3 (42.9)
III	1 (14.3)
IV	2 (28.6)

Values are mean ± standard deviation or number (percentage).

Abbreviations: I, first step; II, second step; III, third step; IV, fourth step; ASA, American Society of Anesthesiologists; COPD, chronic obstructive pulmonary disease; eGFR, estimated glomerular filtration rate; EVAR, endovascular aneurysm repair; TIA, transient ischemic attack.

Five patients received elective staged treatment, whereas 2 patients were treated in an urgent setting with a single-step treatment. Percutaneous access was performed in 6 cases. In 2 cases, it was necessary to pre-dilate the iliac axis using Shockwave.

Table 2 shows the details for each single procedure performed. The average fluoroscopy time was 134±62 minutes, while the average treatment duration was 321±102 minutes. The mean hospital stay was 22.3±7.06 days. Intraprocedural complications were detected in 2 cases: 1 case was of renal artery dissection and 1 case was of collateral renal rupture, both of which were endovascularly resolved. Complications at 30 days were 2 cases of renal failure, of which 1 required dialysis, 1 case of multiorgan failure resulting in death, and 1 percutaneous access pseudoaneurysm treated by placement of covered stent.

Table 2.

Description of the Procedures for Each Patient, With Details on the Staging and Technical Notes.

Patient	B-EVAR	TEVAR	EVAR	CT	SMA	RtRA	LtRA	Note
1	I		I	II	I	I	I	Cross leg, double barrel
2	S	S		S	S	S	S
3	I			II	I	I	I	CT plug, cross leg
4	II	I		II	II	II	II	Supra-aortic vessels debranching, cross leg, double barrel
5	S			S	S	S	S
6	I	I	II	III(antegrade cannulation)	I	I	I
7	I			To be performed	I	I	I

Abbreviations: I, first step; II, second step; III, third step; B-EVAR, branched endovascular aneurysm repair; CT, celiac trunk; EVAR, endovascular aneurysm repair; LtRA, left renal artery; RtRA, right renal artery; S, single step; SMA, superior mesenteric artery; TEVAR, thoracic endovascular aortic repair.

In total, 26 of 28 treated vessels were retrograde cannulated with a technical success of 93%. In particular, the right renal artery, the left renal artery, and the superior mesenteric artery were cannulated for all patients. As for the celiac tripod, it was not possible to engage retrograde in 1 case due to Heli FX 22 unavailability, while in the last case treatment has yet to be completed. In 1 case, the celiac tripod was chronically occluded, and a plug was placed inside the bridging stent.

In all cases, the Viabahn VBX was adopted as the stent bridge with a total of 39 stent bridges being used. In 3 cases, the stent bridges of the renal arteries were positioned in cross leg, while in 2 cases a double barrel was made on the bifurcation branches of the renal artery.

Details on the number, diameters, and lengths of stents used, in accordance with the target vessel are reported (Figure 3). Briefly, the 6 mm diameter was the most used for the renal arteries, while the 8 mm diameter was the most used for the celiac tripod and the superior mesenteric. Finally, the most used length was that of 79 mm for all target vessels. To obtain an adequate landing zone, 2 Viabahn VBX stents were deployed in the following cases: once in the celiac trunk, 5 times in the left renal artery, 4 in the right renal artery, and 3 in the superior mesenteric artery. In all the other cases, only 1 stent was sufficient for adequate sealing.

The mean follow-up was 5.8±4.2 months. Additional mortality was not observed during follow-up. As regards the patency of the stent bridges, 1 occlusion of a stent of the renal artery was observed, but no reinterventions were needed.

Discussion

A retrospective analysis was carried out on an initial consecutive series of 7 cases endovascularly treated with inner branch devices using the retrograde approach.

The E-nside device was designed to facilitate antegrade cannulation of inner branches by having the branches pre-cannulated. The antegrade approach has some criticalities that can condition the onset of complications both in the axillary or subclavian access site and of ischemic cerebral type.^8,9 Furthermore, particular anatomical conditions should be taken into consideration (previous debranched aortic arch, frozen elephant trunk, supra-aortic vessels tortuosity), which may render antegrade cannulation technically impracticable.

In this scenario, having alternative techniques available can allow for the broadening of indications for complex aortic endovascular treatment, a treatment that in some cases must also be performed in an urgent setting.

Recently, some authors have published the first case report on this topic.⁷ Other recently published papers on the retrograde cannulation of branches during B-EVAR, concerning both inner and outer branches, as well as different steerable sheaths, are listed in Table 3.

Table 3.

Records From Recently Published Papers on Retrograde Cannulation of Branches During B-EVAR.

Author	Study	No. of patients	No. of target vessels	Endograft	Technical success	Sheath	Complications	Stent type
Andic et al¹⁰	Retrospective	2	8	E-nside	100%	Fustar	0	VBX
Eilenberg et al⁸	Retrospective	60	209	t-Branch/CMDs	100%	Fustar/Flexor	0	-
Hauck et al¹¹	Retrospective	7	19	t-Branch/E-nside/CMDs	100%	Helifx	1 access related	VBX/Begraft/Advanta V12
Makaloski et al⁶	Retrospective	4	8	CMDs	100%	Oscor	-	-
Töpel et al¹²	Retrospective	12	33	-	100%	Oscor	-	VBX
Our experience	Retrospective	7	26	E-nside	93%	Helifx	2	VBX

Abbreviations: B-EVAR, branched endovascular aneurysm repair; CMDs, custom made devices; VBX, Viabahn balloon expandable stent.

In this article, we address the use of a technique that involves the positioning of a 20 F introducer sheath up to the inside of the branched component as well as the Heli FX catheter for retrograde engagement of the branch. It should be noticed that one of the issues with retrograde approach is the need to give stability to the introducer, in order to advance and position the stent.

Indeed, the retrograde cannulation of branches in thoraco-abdominal repair can be performed by using two different devices: commercially available steerable sheaths, with possibly some surgeon modifications, and home-made steerable solutions.

The main difference among the commercially available steerable sheaths (Table 4) is that the Oscor Destino (Palm Harbor, FL, USA)¹³ and the Fustar (Lifetech Scientific, Shenzhen, China) have a lower outer diameter compared with the Heli-FX (Medtronic, Minneapolis, USA), which is beneficial in preventing lower limbs and spinal cord ischemia. On the other hand, the Heli-FX (Medtronic, Minneapolis, USA) provides the advantage of guaranteeing a higher stability.

Table 4.

Main Characteristics of the Commercially Available Steerable Sheath Used for Retrograde Cannulation of Branches.

Steerable sheath	Outer diameter (F)	Deflected tip reach (mm)	Length (cm)
Heli-FX	16	22 and 28	62
Oscor Destino	6.5–12	9–22	45–90
Fustar	5–14	25 and 50	55–90

A surgeon modification to increase the stability, by suturing the tip of the steerable sheath, has been described by Lemmens et al.¹⁴

The use of steerable sheath has also been adopted by some authors for the retrograde cannulation of supra-aortic trunks in cases of inner branch for the aortic arch.¹⁵ However, the main difficulty encountered in this anatomical zone continues to be represented by the insufficient stability guaranteed by the device.

The main limitation to the use of steerable sheaths may be due by the size of the bridging stent graft. In case a large bridging stent is required, this can be regarded as an indication for the antegrade cannulation from the upper extremity access.

As for the home-made solutions, two main strategies have been described: the through-and-through suture technique¹⁶ and the wire loop directional sheath technique.¹⁷ A suture, in the first case, and a hydrophilic nitinol wire, in the second case, are used to create a curve on the tip of a standard sheath. These solutions have lower cost compared with the steerable sheaths, but the presence of the suture/wire does not allow the cannulation of the branch, thus providing a lower stability.

The forgoing considerations motivate our decision to use the steerable sheath, and, specifically, the Heli FX catheter, which has a higher profile and provides greater support. Moreover, to achieve technical success, it is essential to have the Heli FX catheter with minor curvature available so as to allow the catheter to reach the correct working position. Our technique has not only proven to be feasible, but also allows for more complex procedures such as reverse double barrel.

The other aspect for technical success is the bridging stent choice. In our experience, we have always used the Viabahn VBX. In a previous study,¹⁸ we have already shown how this stent better maintains its circular shape, thus allowing for superior resistance to kinking at the take-off angle of the target vessel when compared with the other commonly used covered stents. In addition to this important feature, the choice of this stent type was also made on the basis of the crimping of the stent on the balloon, which is likely what allows it to have better navigation properties compared with other covered stents.¹⁹

One of the main limitations of the proposed technique is represented by the need to place a 20 F introducer within the iliac axis, which could reduce spinal cord perfusion and therefore increase the risk of spinal cord ischemia. For this reason, an evaluation of the patency of the contralateral internal iliac axis should always be carried out. In our practice, we have always positioned the armed introducer from the ipsilateral iliac axis, that is from the same positioning side of the branched main body, thus ensuring the perfusion of the contralateral hypogastric artery.

Conclusion

In conclusion, even in inner branched cases, retrograde cannulation can be successfully performed. This technique can be implemented and therefore taken into consideration in particular cases, or it could become the option of choice if our promising results are confirmed by a series of studies with a greater number of evaluated patients. Granted, having dedicated endovascular material available such as steerable catheters and latest generation covered stents is fundamental for the success of the treatment.

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 iDs

Giovanni Spinella

Bianca Pane

Alice Finotello

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