Ann Thorac Surg 2009;88:637-640. doi:10.1016/j.athoracsur.2008.12.078
© 2009 The Society of Thoracic Surgeons
New Technology
Endovascular Repair of the Descending Aorta and the Aortic Arch With the Relay Stent Graft
Martin Funovics, MDa,*,
Melanie Blum, MDa,
Herbert Langenberger, MDa,
Christina Plank, MDa,
Maria Schoder, MDa,
Gundula Edelhauser, MDa,
Roman Gottardi, MDb,
Dominik Berzacky, MDa,
Marion Dorfmeister, MDb,
Michael Grimm, MDb,
Johannes Lammer, MDa,
Martin Czerny, MDb
a Cardiovascular and Interventional Radiology, Medical University of Vienna, Vienna, Austria
b Department of Cardiothoracic Surgery, Medical University of Vienna, Vienna, Austria
Accepted for publication December 18, 2008.
* Address correspondence to Dr Funovics, Cardiovascular and Interventional Radiology, Medical University of Vienna, Wahringer Gurtel 18-20, Vienna, 1090, Austria (Email: martin.funovics{at}meduniwien.ac.at).
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Abstract
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Purpose: The aim of this study was to evaluate the efficacy and safety of thoracic endovascular aortic repair with a newly designed Relay thoracic stent graft (Bolton Medical, Sunrise, FL).
Description: Between 2005 and 2007, 22 patients (71.8 ± 8.5) received 24 stent grafts. Indications were aneurysms (n = 13), penetrating atherosclerotic ulcers (n = 7), and dissections (n = 2). Due to the proximity of the lesions to the aortic arch, rerouting procedures (ie, subclavian transposition [n = 1], double transposition [n = 12], and total arch rerouting [n = 6] were performed pre-interventionally; three patients did not undergo rerouting). All patients were followed-up with a computed tomographic scan of the entire aorta at discharge, 3 months, 6 months, and annually thereafter (mean follow-up, 13 months).
Evaluation: Primary technical success was obtained in 20 of 22 patients, with one persisting type I endoleak and one asymptomatic type II endoleak. One patient died due to malignant arrhythmia 3 days after stent-graft placement. During follow-up, 1 nonaortic related death was observed. No additional endoleaks were observed. Finally, all supra-aortic rerouting procedures remained patent.
Conclusions: In the treatment of degenerative disease of the descending aorta and the aortic arch, the Bolton Relay stent graft offers acceptable efficacy and safety in short-term follow-up.
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Technology
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During the last decade, endovascular repair of the thoracic aorta with stent grafts has been increasingly performed on patients with more advanced age and on lesions further in the aortic arch [1, 2] due to the more liberal application of pre-interventional rerouting procedures [3, 4]. Treatment of such lesions puts a higher demand on the stent graft in terms of flexibility, ability to be pushed, controlled release, and the ability to conform to the aortic wall in the proximal and distal sealing zones. Aim of the present study was to evaluate the efficacy and safety of a new stent graft specifically designed for the treatment of lesions in or near the aortic arch.
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Technique
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Patients and Methods
The basis of the present prospective feasibility and safety report is the subgroup of 22 patients implanted with the Relay stent graft (Bolton Medical, Sunrise, FL) between 2005 and 2007. The study was approved by the Institutional Review Board, and written informed consent was obtained from each patient.
The Relay thoracic stent graft (Bolton Medical) incorporates design features to facilitate deployment and apposition in the aortic arch by: (1) an oblique backbone that tends to rotate toward its intended position at the outer half of the stent graft by itself during application, (2) different distribution of the radial force over the stent segments with the highest forces in the proximal and distal landing zones, (3) a flexible inner sheath with a diameter of 12 mm in which the stent graft is already partially expanded before its final release, and (4) clasped apices of the proximal segment to increase control of the stent segments facing the inner curvature. Patient details and stent dimensions are given in Table 1.
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Table 1 Patient Data, Indications, and Results of Endovascular Treatment of Thoracic Aortic Pathologies with the Relay Stent Graft
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Because previous experience identified the length of the proximal landing zone as one of the most important predictors of complete exclusion of the lesion, a liberal approach was made toward pre-interventional supra-aortic rerouting procedures [5]. The proximal landing zone (defined as the length of the aortic segment between the predicted proximal border of the covered stent segment, and the point where the aortic diameter exceeds 90% of the stent graft diameter) in the current series was larger than 22 mm in all but one case, in which a high likelihood for a type I endoleak was foreseen and to which was consented. Stent graft diameters were selected based on the diameter of the aorta in the middle of the landing zone, and they were oversized by 15%. In cases of significant size differences between the proximal and distal landing zones, tapered stent graft designs were implanted with 4-mm smaller distal diameters. To create a sufficient proximal landing zone, the following pre-interventional rerouting procedures were carried out.
Subclavian-to-carotid artery transposition
The vessel was transected and guided dorsal to the left jugular vein through a skin incision parallel to the left clavicula, followed by end-to-side anastomosis between the subclavian and carotid arteries.
Double transposition
The original method has been previously described in detail [6]. All supra-aortic branches were exposed through an upper hemi-sternotomy approach. An end-to-side anastomosis between the left carotid artery and the brachiocephalic trunk followed by an end-to-side anastomosis between the left subclavian artery and the left common carotid artery was performed (Fig 1).
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Fig 1. (A) Double transposition scheme and (B) computed tomographic parasagittal reconstruction post-stent graft.
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Total arch rerouting
An anastomosis between the proximal portion of an inversed bifurcated vascular prosthesis and the ascending aorta was performed through a full sternotomy and opening of the pericardium. End-to-side anastomoses between the two branches of the prosthesis and the brachiocephalic trunk and the left subclavian artery were done. The left common carotid artery was reinserted into the branch to the left subclavian artery (Fig 2).
Pre-interventional work-up included standardized bolus-triggered multi-detector computed tomography and angiography from the carotid bifurcation to the groin (Somatom 16, [Siemens Medical Systems, Erlangen, Germany] and Brilliance 64, [Philips Medical Systems, Eindhoven, the Netherlands]). Collimation was 0.5 to 1 mm, with reconstruction increments of 0.8 to 1 mm. Axial slices as well as parasagittal reformations along the major axis of the aortic arch were used to determine stent-graft size.
All stent-graft implantations were performed in general anesthesia in the interventional suite. The common femoral artery was surgically exposed on the side where the iliac arteries were larger or less calcified. The brachial artery was punctured percutaneously and a 4-French sheath pigtail catheter was inserted into the ascending aorta. After stent-graft deployment, balloon dilation of the graft was only performed if the final angiography revealed remaining perfusion of the lesion.
Post-implantation follow-up consisted of computed tomographic examinations (ie, identical protocol as pre-implantation) and clinical visits at discharge, 3 months, 6 months, and annually thereafter.
The primary safety endpoint was the total number of major complications or death at the end of the observation period, and the secondary safety endpoints were freedom from implantation-related or device-related complications, or death within 30 days of the intervention. The technical success endpoint was complete exclusion of the lesion at the first computed tomographic follow-up, and the procedural success endpoint was complete exclusion of the lesion at the end of the observation time.
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Clinical Experience
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Results
Technical success
Successful deployment was achieved in all patients (22 of 22; 100%) for all 26 stent grafts. In all cases, actual deployment was within 5 mm of the planned landing point. No inadvertent, complete, or partial overstenting of major supra-aortic vessels occurred. Technical success, defined as total exclusion of the lesion in the follow-up computed tomographic scan at discharge was achieved in 20 of 22 (91%) of the patients. Of the remaining 2 patients, 1 suffered from a 9-cm distal arch aneurysm, underwent subclavian transposition, and had a common origin of the left carotid artery and the brachiocephalic trunk. Because this patient had previously undergone two sternotomies (ie, an ascending aortic replacement and proximal hemi-arch replacement) and suffered from severe cardiac comorbidity and had already received a different descending aortic stent graft with persisting type I endoleak, he was not considered fit for a third sternotomy with total arch rerouting. Thus, it was decided to implant a Bolton Relay stent graft with higher radial force to attempt proximal sealing in the 5-mm proximal neck, although the likelihood of persisting type I endoleak was considered high, the patient consented to it. The second case of endoleak was a type II leak in a patient with several penetrating ulcers in the distal arch, fed by two intercostal arteries, also with stable aneurysm size.
Safety
No paraplegia, paresis, or other neurologic deficit was observed. All patients were extubated within 6 hours after the intervention, and no distal ischemia was observed. One patient died due to malignant arrhythmia 3 days after stent-graft placement. The 30-day overall mortality in this patient group was 4.5%. No major device or implantation-related complications occurred.
Short-term results
Mean follow-up time is 13 months. All 20 patients with primary technical success showed stable results at the end of the observation time and are free from progression of disease at the implantation site. No late device-related or procedure-related complications or deaths occurred. In all cases of dissections, thrombosis of the false lumen at the level of the stent graft was observed after 6 months. Furthermore, all stent grafts expanded to their unconstrained diameter in the true lumen at this time point. One patient died of complications of uremia 9 months after the intervention without causal connection to the implantation procedure (Table 1).
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Comment
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Endovascular stent grafts have been shown to present a viable alternative for the treatment of manifestations of degenerative disease in the thoracic aorta and in the aortic arch. Several case series have documented that endoluminal therapy is associated with less morbidity and mortality [3, 7, 8]. However, although patient enrollment for this method is less limited in terms of patient fitness, its success is highly dependent on case selection, according to the location of the lesion in the aortic arch or the descending aorta, the diameter and surface of the access vessels, the curving of the target site, the proximity to the supra-aortic branches, and the technique of pre-interventional rerouting procedures [8].
Because of the considerable heterogeneity of the reported series concerning these measurements, a direct comparison of stent-graft performance in respective publications is impossible. The Talent registry currently contains 457 patients, with only 27% of the lesions closer than 1 cm of the origin of the left subclavian artery [9]. In 54 of these cases, the subclavian artery was overstented (40% of which required post-interventional revascularization). No intention was made to place a stent graft more proximally. A recent series of 406 patients treated with the Excluder stent graft (W. L. Gore and Associates, Flagstaff, AZ), with only 37 cases in which the left subclavian artery was covered (35% of which required revascularization) [10]. In contrast, the present series comprises considerably more proximal lesions. Only 3 patients did not receive supra-aortic rerouting procedures, and 1 further patient underwent subclavian transposition. In the remaining cases, the proximal landing zone was located between the left carotid and left subclavian artery (12 of 22; 55%) requiring double transposition, and the landing zone was located proximal between the brachiocephalic trunk and left carotid artery in 6 of 22 cases (27%). This distribution reflects the typical challenge of a European tertiary referral center with a dedicated thoracic stent-graft program.
The advantages of the Relay stent graft in the aortic arch are reflected in the results of the current series. Although the percentage of proximal lesions was considerably higher than in previous series, the endoleak rate of 9% and the 30-day mortality of 5.5% are similar [9]. The stability of the results in the current series was excellent (ie, all patients with primary success showed stable exclusion of the lesions at the end of the follow-up period). This may be the result of a liberal application of preoperative rerouting procedures. A second factor favoring efficient proximal sealing of the stent graft is its distribution of the radial force. Potentially, efficient sealing can thereby be obtained, whereas at the same time being able to minimize potential long-term damage to the diseased segment of the aorta.
In conclusion, degenerative lesions in the descending aorta and in the aortic arch can be treated efficiently and safely with the Relay stent graft. Although most lesions were located in the aortic arch and required different rerouting procedures, the resulting technical success and complication rates are similar to the previous series. In combination with the liberal application of pre-interventional transposition procedures providing a long proximal landing zone, the major part of lesions in the mid and distal aortic arch becomes accessible for endovascular treatment with acceptable results in the short-term follow-up.
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Disclosures and Freedom of Investigation
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All technology tested in the study was purchased. All authors had full control of the design of the study, methods used, outcome measurements, analysis of data, and production of the written report.
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Footnotes
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Disclaimer The Society of Thoracic Surgeons, the Southern Thoracic Surgical Association, and The Annals of Thoracic Surgery neither endorse nor discourage use of the new technology described in this article.
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References
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- Bavaria JE, Appoo JJ, Makaroun MS, Verter J, Yu ZF, Mitchell RS. Endovascular stent grafting versus open surgical repair of descending thoracic aortic aneurysms in low-risk patients: a multicenter comparative trial J Thorac Cardiovasc Surg 2007;133:113-177.
- Svensson LG, Kouchoukos NT, Miller DC, et al. Expert consensus document on the treatment of descending thoracic aortic disease using endovascular stent-grafts Ann Thorac Surg 2008;85(1 Suppl):S1-S41.[Abstract/Free Full Text]
- Czerny M, Grimm M, Zimpfer D, et al. Results after endovascular stent graft placement in atherosclerotic aneurysms involving the descending aorta Ann Thorac Surg 2007;83:450-455.[Abstract/Free Full Text]
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- Czerny M, Gottardi R, Zimpfer D, et al. Mid-term results of supraaortic transpositions for extended endovascular repair of aortic arch pathologies Eur J Cardiothorac Surg 2007;31:623-627.[Abstract/Free Full Text]
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- Rodriguez JA, Olsen DM, Shtutman A, et al. Application of endograft to treat thoracic aortic pathologies: a single center experience J Vasc Surg 2007;46:413-420.[Medline]
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