Forced Complete Femoral Approach for Urgent Thoracoabdominal Aneurysm Repair Using an Inner Branched Endograft

Forced Complete Femoral Approach for Urgent Thoracoabdominal Aneurysm Repair Using an Inner Branched Endograft

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Journal Pre-proof Forced complete femoral approach for urgent thoracoabdominal aneurysm repair using an inner branched endograft G. Simonte, G. Fino, G. Isernia, G. Parlani, E. Cieri, L. Baccani, M. Lenti PII:

S0890-5096(19)30907-0

DOI:

https://doi.org/10.1016/j.avsg.2019.10.060

Reference:

AVSG 4722

To appear in:

Annals of Vascular Surgery

Received Date: 27 August 2019 Revised Date:

9 October 2019

Accepted Date: 9 October 2019

Please cite this article as: Simonte G, Fino G, Isernia G, Parlani G, Cieri E, Baccani L, Lenti M, Forced complete femoral approach for urgent thoracoabdominal aneurysm repair using an inner branched endograft, Annals of Vascular Surgery (2019), doi: https://doi.org/10.1016/j.avsg.2019.10.060. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2019 Elsevier Inc. All rights reserved.

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Forced complete femoral approach for urgent thoracoabdominal aneurysm repair using an inner branched endograft G. Simonte, G. Fino, G. Isernia, G. Parlani, E. Cieri, L. Baccani, M. Lenti Unit of Vascular Surgery S. Maria della Misericordia Hospital, University of Perugia, Perugia, Italy

Corresponding author:

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Gioele Simonte, MD, PhD

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Unit of Vascular Surgery

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S. Maria della Misericordia Hospital, University of Perugia

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Piazzale Menghini, 1

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06132 Perugia, Italy

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Phone/Fax +39 075 5786435

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email: [email protected]

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Abstract

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Introduction

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A successful case of urgent type ll thoracoabdominal aneurysm repair with an inner branched

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endograft conducted entirely through femoral accesses without the bailout possibility to achieve

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an upper extremity approach for bridging stents delivery is described.

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Case description

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A 70-year-old male patient underwent hybrid treatment of a thoracic aortic aneurysm on

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complicated type B dissection in two steps. First, arch debranching with carotid-carotid-subclavian

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bypass and then ascending aortic replacement with re-implantation of the anonymous trunk plus

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TEVAR were performed.

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The scheduled one-month control CTA showed a rapid increase of the false lumen

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thoracoabdominal aneurysm, with axial diameter measuring more than 10 cm. The repair

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procedure was based on the use, as off-the-shelf graft, of a prosthesis customized for another

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patient with inner-branches for visceral vessels that well suited the characteristics of the case.

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A steerable guiding sheath was essential to stabilize the system in the selective and sequential

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cannulation of two of the four inner-branches (for celiac trunk and superior mesenteric artery) and

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to complete the bridging stents deployment. Procedure was carried out without complications.

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Conclusion

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In an urgent setting, total endovascular correction of a thoracoabdominal aortic aneurysm

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exclusively through femoral accesses appears to be feasible when the appropriate tools are

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available.

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INTRODUCTION

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Ruptured thoracoabdominal aortic aneurysm (TAAA) still represents a high demanding set-up for vascular surgeons even in the endovascular era. Elective minimally invasive treatment of complex TAAAs using fenestrated/branched stentgrafts has become the standard of care for high-risk patients during the last years with satisfactory results even in the long term.1 Nevertheless, correction with a custom made endograft in an urgent setting remains unviable. The t-Branch graft (Cook Medical, Bloomington, IN, USA) is the only available offthe-shelf device designed for emergent use in TAAA, however its configuration does not fit any possible anatomy.2,3 The first and most employed model of custom made branched endografts contemplates antegrade branches and the implantation technique requires an upper limb access to catheterize branches and target vessels. Recently a new endograft configuration has been proposed, with the possibility to design retrograde branches for better matching the direction of visceral arteries in case of upward orientation. We describe a successful case of post-dissection thoracoabdominal aneurysm repair using an inner branched endograft conducted entirely through femoral accesses. A steerable guiding sheath was needed to achieve cannulation of the two downward facing branches and to complete the bridging stents deployment.

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CASE REPORT AND TECHNIQUE

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Written consent was obtained from the patient for anonymous usage of data and images for scientific purposes. A 70-year-old male patient was admitted to the emergency room of a peripheral hospital because of chest pain and right lower limb acute ischemia. He underwent computed tomography angiography (CTA) that revealed a 45 mm aneurysmal dilatation of the ascending aorta and a type B aortic dissection on a 63mm descending thoracic aortic aneurysm with left pleural effusion. The right iliac axis was dissected with complete obliteration of the true lumen (Fig. 1). Patient was admitted to the cardiac intensive therapy unit and underwent intravenous antihypertensive therapy and clinical monitoring with spontaneous regression of the lower limb ischemia. After 3 days a control CTA showed true lumen re-expansion at the level of the right iliac axis with concomitant increase in left pleural effusion. The

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patient was then transferred, completely asymptomatic, to a high volume vascular surgery unit. The case was submitted to the local heart team (vascular surgeons, cardiac surgeons, interventional radiologists and anesthesiologists) and a multistep hybrid correction was planned. First, an extra anatomical partial arch debranching through carotid-carotidsubclavian bypass was performed. After four days the second step was conducted in a hybrid operating theater equipped with a ceiling-mounted fixed angiography (Allura, Philips, Amsterdam, The Netherlands). Open surgery with ascending aortic replacement and ascending to innominate artery by-pass was followed by endovascular zone zero endograft deployment (Gore TAG 40- 40-200mm and Gore TAG 45-45-200) and plug embolization of the left subclavian artery into the prevertebral segment. There were no technical complications as completion angiography showed correct positioning of the endograft, absence of endoleak and no sign of malperfusion. A postoperative CTA scan confirmed these findings. Patient was discharged on post-operative day (POD) 28 in good general condition with a computed tomography follow-up scheduled at three months. The control imaging investigation showed a prominent enlargement of the type ll thoracoabdominal aortic aneurysm on chronic type B dissection, with a maximum axial diameter of 100 vs 63 mm of the last post-operative CTA (Fig. 2). Celiac trunk, superior mesenteric (SMA) and right renal arteries arose from the true lumen while left renal artery originated from the false lumen. The common hepatic artery presented an abnormal origin from the superior mesenteric. Furthermore, since false lumen ended blindfold at the aortic bifurcation and no lamella perforation was evident below the SMA origin, there was no viable access to the left renal artery from below. So far, the endovascular option for the urgent treatment of thoracoabdominal aortic aneurysm is essentially represented by the deployment of a Zenith t-Branch (Cook Medical, Bloomington, IN, USA) or of parallel grafts (chimney, periscope, sandwich, CHIMPs). These procedures require transbrachial or transaxillary accesses in order to deploy visceral vessel covered stents. Since we previously performed a complete arch debranching with an impracticable sharp angle at the origin of the ascending to innominate artery by-pass (Fig. 3), we did not have the possibility to take advantage of an access from above. Thus, it was necessary to study an alternative approach. The planned procedure was based on the use, as off-the-shelf graft, of a customized prosthesis (Jotec® E-xtra design engineering, Hechingen, Germany) ordered for

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another patient. The graft presented four inner-branches (two antegrade and two retrograde) for visceral vessels that suited the vascular anatomy of the patient. Several anatomical considerations were made when selecting the endograft, having the available alternative of a t-Branch. The most important issue was the anticipated difficulty to access the right renal artery. The possibility of pushing from below was considered a significant advantage. Furthermore, true lumen was very narrow in some points and using inner branches could have minimized problems deriving from lack of space (i.e., no possibility of outer branch collapse). Surgery was performed under general anesthesia and systemic heparinization in a hybrid operating room. Protection from spinal cord ischemia was accomplished through liquor drainage. Pre-operative CTA scans were imported in the 3D workstation and processed using dedicated software (Vessel Navigator, Philips, Amsterdam, The Netherlands) which overlays the 3D computed CTA volume on live fluoroscopy, providing a continuous three-dimensional roadmap, synchronized real time with C-arm movements. Ring markers were placed at the origin of visceral branches. Surgical left common femoral artery exposure and percutaneous right common femoral artery access were accomplished with preimplantation of two Proglide closure devices (Abbott Vascular, Redwood City, CA, USA). From the right femoral access, a steerable sheath Destino 10Fr (Oscor Destino™, Oscor, Palm Harbor, FL, USA) was advanced, angulated and apposed against the intimal chronical dissecting flap. Using the back stiff end of a hydrophilic guidewire (Terumo Aortic Ltd, Renfrewshire, Scotland, UK) an intimal perforation was obtained at the level of the projection of the right renal artery ostium to obtain vessel access from the true lumen. The newly created intimal tear was than dilated, right renal artery catheterized, and a guidewire placed in position as a landmark (Fig. 4). From the left access, on a super-stiff guidewire, the branched endograft was advanced and positioned according to the radio-opaque markers and to the fusion software landmarks. The custom-made graft was deployed and a Gore TAG 45-45-150mm implanted as bridging component between the thoracic endoprosthesis, already in place, and the custom made device. A 32mm Gore Aortic Extender was deployed in the distal abdominal aorta to complete sealing. Sealing zone and component overlaps were expanded with a Coda balloon (Cook Medical, Bloomington, IN, USA). The left common femoral access was then closed reperfusing the left lower limb. The 10 Fr steerable sheath was introduced again from the right femoral artery to access the downward inner-branch for the SMA. The sheath was steered to a tip

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angle of 180°, branch and target vessel cannulated and a BeGraft 8-57mm (Bentley Innomed, Hechigen, Germany) deployed. Selective angiography showed correct position of the bridging stent and patency of the treated vessel (Fig. 5). The same technique was applied for catheterization of the celiac trunk and a bridging stent Eventus 8-57mm (Jotec, Hechingen, Germany) was deployed (Fig. 6). Selective angiography showed patency of the left gastric and splenic arteries. Both retrograde inner-branches for the renal arteries and the respective target vessels were catheterized in retrograde fashion and a Viabahn 8-50mm (W. L. Gore & Associates, Flagstaff, AZ, USA) was bilaterally deployed. Completion angiography confirmed target vessel patency and showed a low flow endoleak of uncertain origin (Fig. 7a). The intraoperative CT control did not show disconnections between the prosthetic modules that appeared correctly positioned. Contrast medium dose was 240ml with a fluoro time of 201’45’’. The patient remained stable during surgery and the following hours. Liquor drainage was removed on POD 4 since no neurological complications were detected. The post-operative course, on POD 12, was complicated by respiratory failure and acute heart failure due to right lung pneumonia, with concomitant almost complete atelectasis of the left lung. This clinical condition required transfer to the intensive care unit and subsequent respiratory rehabilitation. After 42 days the patient was discharged in good general condition. The 3-month CTA control showed patency of all side branches and a type II endoleak filled from a pair of lumbar arteries and the inferior mesenteric artery with stable aneurysmal sac diameter (Fig. 7b). At 8 months the last available imaging shows significant shrinkage of the residual aneurysmal sac with reduction of the type II endoleak intensity.

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DISCUSSION

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Steerable sheaths have been initially developed with the purpose of being used in complex interventional cardiac procedures such as atrial fibrillation ablation with trans-septal access, endocardial ablation and transcatheter aortic valve replacement. In the last decade, several trials and prospective studies on the utility of these devices have been published, mostly reporting significant reduction in procedural fluoroscopy time and high rates of clinical success. 4-7 Regarding aortic applications in vascular surgery, while the use of steerable sheaths was originally conceived to deliver the Aptus Heli-FX Aortic EndoAnchor System, the

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possibility of avoiding upper limb access in complex procedures appeared as a different and appealing device use. At least two papers reported on the use of steerable sheaths in the deployment of an Iliac branched device hypogastric component through contralateral femoral approach in patients with an aortic bifurcated endograft already in place.8-9 Challenging vessel catheterization is actually the most investigated and discussed technical topic in complex aortic repair while urgent treatment of complex TAAAs is an ever-present challenge. Currently, in urgency, when the patient is not suitable for surgical treatment, the only possibility for the vascular surgeon in the treatment of complex TAAA aneurysm is the use of off-the-shelf prostheses, such as the t-branch, or an off-label application of a combination of aortic endograft and visceral covered stent with CHIMPs technique. In both cases the standard implantation procedure requires the use of axillary/brachial accesses to complete the repair. The access from above, although currently representing the first choice in the cannulation of anterograde branches, exposes the patient to stroke risk and to possible access-related complications such as hematoma, nerve compression or arterial obstruction.10 Recently, initial and isolated experiences regarding the possibility of exclusively using retrograde access for selective cannulation of antegrade branches have been published. In the different reports the procedure feasibility relies on the use of steerable sheaths. Makalosky et al. first described this technique in a report on four patients undergoing abdominal or thoracoabdominal branched endovascular repair involving 1 to 4 branches, concluding that this procedure appears feasible and effective and may potentially decrease the need for upper extremity access and therefore lessen the risk of periprocedural stroke during complex endovascular procedures.11 More recently Orrico et al. reported a case of the Destino-guided branched endovascular aortic repair, considering the approach safe, largely applicable and therefore a valid adjunct to the complex endovascular solution portfolio.12 The procedure is suggested to be even faster with solely femoral accesses compared to the conventional approach. Watkins et al. described how, in a case of ruptured TAAA, the ability to cannulate branch vessels expeditiously from a single access reduced operative time to 98 minutes.13 In all the described cases, although not specifically disclosed, we might argue that the authors could have used an access from above in the case of challenging or

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impossible cannulation from femoral access as bailout. Here a case in which the femoral approach was the only endovascular possibility is reported.

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CONCLUSION

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With the present experience, it is demonstrated that total endovascular correction of a thoracoabdominal aneurysm exclusively through the femoral accesses is feasible in an urgent setting when the appropriate tools are available. Greater experience, possibly from multicenter registries and careful follow-up, is however necessary to confirm technical success and investigate possible accessrelated complications and branch vessel patency compared to classical upper extremity approach.

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Figure Legends :

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Figure 1: Three dimensional reconstruction and axial views of the first CT scan. Notice the occlusion of the right common iliac artery. Figure 2: Post-operative (a) and three-month control CT scan (b). Clear enlargement of false lumen aneurysm in axial views. Figure 3: Three dimensional reconstruction of the arch after total debranching. Notice the sharp angle between the origin of the ascending to innominate by-pass and the ascending aorta. Figure 4: Lamella perforation (a) obtaining access to the true lumen from below (b). Tear dilatation (c) and wire positioned into renal arteries as landmarks (d). Figure 5: SMA cannulation and bridging stent deployment using steerable sheet. Figure 6: Celiac trunk cannulation and bridging stent deployment using steerable sheet. Figure 7: Final Angio (a) and control CT scan three dimensional reconstruction (b).

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Note: A recorded video of the described case has been uploaded in the “Vascupedia” elearning platform under the name “Complex multi stage thoracoabdominal aneurysm correction. Branched endograft with forced femoral access and flap perforation”.(https://vascupedia.com/presentation/complex-multi-stagethoracoabdominal-aneurysm-correction-branched-endograft-with-forced-femoralaccess-and-flap-perforation/). The authors suggest the vision to better understand the particular features of the case.

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References

1. Walker J, Kaushik S, Hoffman M, et al. Long-term durability of multibranched endovascular repair of thoracoabdominal and pararenal aortic aneurysms.. J Vasc Surg. 2019 Feb;69(2):341-347.

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2. Gasper WJ, Reilly LM, Rapp JH, et al. Assessing the anatomic applicability of the multibranched endovascular repair of thoracoabdominal aortic aneurysm technique. J Vasc Surg 2013, 57:1553-8

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3. Silingardi R, Gennai S, Leone N et al. Standard "off-the-shelf" multibranched thoracoabdominal endograft in urgent and elective patients with single and staged procedures in a multicenter experience. J Vasc Surg. 2018 Apr;67(4):1005-1016.

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5. Rajappan K, Baker V, Richmond L, et al. A randomized trial to compare atrial fibrillation ablation using a steerable vs. a non-steerable sheath. Europace 2009, 11:571-575.

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6. Arya A, Hindricks G, Sommer P, et al. Long-term results and the predictors of outcome of catheter ablation of atrial fibrillation using steerable sheath catheter navigation after single procedure in 674 patients. Europace 2010, 12:173-180.

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7. Piorkowski C, Eitel C, Rolf S, et al. Steerable versus nonsteerable sheath technology in atrial fibrillation ablation. A prospective, randomized study. Circ Arrhythm Electrophysiol 2011, 4:157-165.

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8. Oberhuber A, Duran M, Ertas ̧ N, et al. Implantation of an iliac branch device after EVAR via a femoral approach using a steerable sheath. J Endovasc Ther 2015, 22:610-612.

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9. Ferrer C, Venturini L, Grande R, et al. A Steerable Sheath to Deploy Hypogastric Bridging Stent by Contralateral Femoral Approach in an Iliac Branch Procedure after Endovascular Aneurysm Repair. Ann Vasc Surg 2017, 44:415.e1-415.e5.

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10. Fiorucci B, Kölbel T, Rohlffs F, et al. Right brachial access is safe for branched endovascular aneurysm repair in complex aortic disease. Right brachial access is safe for branched endovascular aneurysm repair in complex aortic disease. J Vasc Surg 2017, 66:360-366.

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11. Makaloski V, Tsilimparis N, Spanos K, et al. Use of a Steerable Sheath for Retrograde Access to Antegrade Branches in Branched Stent-Graft Repair of Complex Aortic Aneurysms. J Endovasc Ther 2018, oct; 25(5):566-570

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12. Orrico M, Ronchey S, Setacci C, et al. The ‘‘Destino-guided BEVAR’’ to Catheterize Downward Branches from a Femoral Access: Technical Note and Case Report. Ann Vasc Surg 2019 May; 57:266271

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13. Watkins A.C, Avramenko A, Soler R, et al. A novel all-retrograde approach for t-Branch implantation in ruptured thoracoabdominal aneurysm. J Vasc Surg Cases Innov Tech 2018, 4:301-304.

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4. Cohen TJ, Choi D. The utility of a steerable long introducer sheath to facilitate left ventricular lead placement during a complex biventricular implantable cardioverter-defibrilator implant. s.l. : J Invasive Cardiol 2004, 16:600-601.

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