Thoracic endovascular stent graft repair for ascending aortic diseases

Thoracic endovascular stent graft repair for ascending aortic diseases

Thoracic endovascular stent graft repair for ascending aortic diseases Gabriele Piffaretti, MD, PhD,a Viviana Grassi, MD,b Chiara Lomazzi, MD,c Willia...

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Thoracic endovascular stent graft repair for ascending aortic diseases Gabriele Piffaretti, MD, PhD,a Viviana Grassi, MD,b Chiara Lomazzi, MD,c William T. Brinkman, MD,d Tulio P. Navarro, MD,e Michael P. Jenkins, MD,f and Santi Trimarchi, MD, PhD,g,h on behalf of the GREAT participants,* Varese, Milan, and San Donato Milanese, Italy; Plano, Tex; Belo Horizonte, Brazil; and London, United Kingdom

ABSTRACT Objectives: We describe the preliminary results of thoracic endovascular aortic repair (TEVAR) in a group of patients with ascending aortic disease from the Global Registry for Endovascular Aortic Treatment (GREAT). Methods: We identified TEVAR performed for diseases truly originating from the ascending aorta. Between July 2011 and May 2015, 5014 patients were enrolled; six (0.12%) were identified and included in the analysis. One further patient was withdrawn from the study due to lack of a signed consent form. Patients having a “zone 0” proximal landing zone reported for their TEVAR without the presence of an ascending aortic disease were not included. Reinterventions of previous open and endovascular repair were also excluded. Results: Three males and three females were treated. Mean age was 69 years ± 10 years (range, 58-83 years). Indication for TEVAR was atherosclerotic aneurysm (n ¼ 4; ruptured, n ¼ 1), complicated type A dissection (n ¼ 1, rupture), and pseudoaneurysm (n ¼ 1). Mean maximum aortic lesion diameter was 60 mm 14 (range, 39-77 mm). Urgent intervention was performed in three (50%) cases. Primary clinical success was 100%. There was no TEVAR-related in-hospital mortality. Open conversion was never required. Complication such as cerebrovascular accidents, valve impairment, or myocardial infarction did not occur. All patients were discharged home alive. No patient was lost at a median follow-up of 26 months (range, 16-72 months). During the follow-up, no patient died and ongoing primary clinical success was maintained in all patients. Reintervention was never required; endoleaks, migrations, fractures, or ruptures were not observed. Conclusions: Preliminary “real-world” experience of ascending TEVAR shows satisfactory outcomes at short-term followup. Although concerns remain for “off-label” use of standard devices, TEVAR-related complications were not observed. Longer follow-up data are expected to confirm durability of these results. (J Vasc Surg 2019;-:1-6.) Keywords: Ascending TEVAR; Ascending aortic aneurysm; GREAT registry

Although randomized clinical trials represent the benchmark method to perform research studies, prospective registries are a valid alternative research method to obtain prompt “real-world” data on safety, efficacy, and

From the Vascular Surgery, Department of Medicine and Surgery, Circolo University Teaching Hospital, University of Insubria School of Medicine, Varesea; the Vascular Surgery, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milanb; the Vascular Surgery II,c and Thoracic Aortic Research Center,g IRCCS Policlinico San Donato, San Donato Milanese; the Heart Hospital Baylor Plano, Planod; the Hospital das Clínicas da Universidade Federal de Minas Gerais (HC-UFMG), Belo Horizontee; the St Mary’s Hospital, Imperial College Healthcare NHS Trust, Londonf; and the Department of Biomedical Sciences for Health, University of Milan, Milan.h

*A list of the collaborators is given in the Appendix (online only). ClinicalTrials.gov identifier: NCT01658787. Author conflict of interest: S.T. is a consultant for Medtronic Inc and W. L. Gore and recipient of research grants to his institution from them. Additional material for this article may be found online at www.jvascsurg.org. Correspondence: Gabriele Piffaretti, MD, PhD, Vascular Surgery, Department of Medicine and Surgery, Circolo University Teaching Hospital, University of Insubria School of Medicine, Via Guicciardini 9, 21100 Varese, Italy (e-mail:

durability of a specific treatment with newer techniques or for rare diseases.1 Thoracic endovascular aortic repair (TEVAR) has demonstrated better results than open repair in several aortic clinical scenarios, but it is currently challenged by the anatomic landmarks, complex anatomy, and hemodynamic forces in the ascending aorta.2-4 To date, standard thoracic or abdominal aortic stent grafts (SGs) have been used “off-label,” and encouraging results have been reported in selected cases.5-7 The Global Registry for Endovascular Aortic Treatment (GREAT) is an international, multicenter, prospective, industry-sponsored (W. L. Gore & Associates, Flagstaff, Ariz) initiative that has been developed to collect realworld performance outcomes in patients treated with Gore aortic SGs.8 With enrollment of patients in the GREAT completed in 2016, this report aims to describe the preliminary results of TEVAR for ascending aortic diseases with Gore aortic devices that are commercially available but not designed to treat ascending diseases.

[email protected]). The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest. 0741-5214 Copyright Ó 2019 by the Society for Vascular Surgery. Published by Elsevier Inc. https://doi.org/10.1016/j.jvs.2019.01.075

METHODS Patient cohort. GREAT enrolled patients from 114 participating centers in North and South America, Europe, Australia, and New Zealand. To reflect realworld experience, exclusion criteria were minimal (only 1

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Fig 1. Preoperative (A-C) and postoperative (D) computed tomography angiography with multiplanar reconstruction (E) of an ascending aortic rupture treated with “off-the-shelf” use of three abdominal aortic extender abdominal aortic cuffs.

the inability to give informed consent). All ascending cases were treated outside the instructions for use for these devices. The registry was conducted according to the Declaration of Helsinki, the International Conference on Harmonization, and Good Clinical Practice guidelines and approved by the ethical committee or institutional

review board of each participating center. We identified TEVAR performed for diseases truly originating from the ascending aorta. After a detailed discussion of the risks and benefits of an open repair or an endovascular alternative, informed consent to proceed with TEVAR was obtained from all patients. Between July 2011 and May

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Table I. Comorbidities and risk factors of the cohort Variable

No. (%)

Comorbidities Hypertension

6 (100)

Cerebrovascular disease (stroke or carotid disease)

4 (67)

Coronary artery disease

3 (50)

Chronic obstructive pulmonary disease

3 (50)

Hypercholesterolemia

3 (50)

Valve disease

2 (25)

Cardiac arrhythmia

2 (33)

Peripheral artery obstructive disease

2 (33)

Renal insufficiency

1 (17)

Congestive heart failure

1 (17)

Previous cardiac intervention Coronary artery bypass graft

1 (17)

2015, there were 5014 patients enrolled; 6 (0.12%) were identified and included in the analysis. One other patient was withdrawn from the study because of lack of a signed consent form. Patients having a “zone 0” proximal landing zone reported for their TEVAR without the presence of an ascending aortic disease were not included. Reinterventions of previous open and endovascular repair were also excluded. All patients analyzed were considered at high risk for open repair at the time of presentation after a multidisciplinary team debate (cardiac and vascular surgeons, interventional cardiologists, anesthesiology staff).9 Patients agreed to publication of their case details and images by signing the study informed consent form. Complete thoracoabdominal computed tomography angiography was performed in all cases to evaluate the anatomy of the ascending aorta (Fig 1, A-C). As generally occurs for all TEVAR procedures, the most adequate size of SG was selected on a threedimensional centerline reconstruction workstation. For aortic dissection and pseudoaneurysm cases, an SG diameter equal to the wall-to-wall diameter without oversizing was used. For aortic aneurysms, the SG was oversized 20% on the basis of the larger of the two measurements at either the sinotubular junction or the distal ascending aorta. The type of SG was determined by the ascending aortic length and the diameter measured immediately above the sinotubular junction (proximal landing zone at the tubular portion of the ascending aorta). Supra-aortic trunk and brain vessels were evaluated to assess the integrity of Willis circle and dominance of the vertebral arteries and to plan aortic arch debranching if needed. TEVAR was performed in the operating room under general anesthesia, with the cardiac perfusion team on standby; transesophageal echocardiography monitoring was used in all cases. During the intervention, weight-adjusted heparinization was administered intravenously to keep an activated clotting

time of at least >250 seconds throughout the procedure. SG insertion site was selected according to size of the access artery, device characteristics, and ascending/arch anatomy. Preliminary angiography was always performed to identify the ostium of the coronary arteries and the brachiocephalic trunk takeoff; the brachiocephalic trunk was the anatomic border of the distal landing zone. The SG was deployed under temporary overdrive cardiac pacing (generally, 190 beats/min) through a transvenous pacing catheter. Follow-up was performed according to the schedule of each participating center and included clinical visit and triple-phase computed tomography angiography (Fig 1, D and E). Either abdominal or thoracic standard devices (Excluder or C-TAG; W. L. Gore & Associates) were implanted. Data collection, processing, and analysis. Collected data were recorded on a web-based electronic report form (iMedidata; Medidata Worldwide Solutions, Inc, New York, NY) to ensure reliability and secure authentication and traceability. Data management was performed by the Gore Clinical Research Department (W. L. Gore & Associates). All collected data were reviewed, and if missing or inconsistent data were detected, relevant queries were posed to the investigators for resolution. Monitoring visits were performed at each enrollment site to verify necessary study documents, including signed informed consent for each patient. Consistency between electronically imported data and source documents was also examined. Statistical analysis was performed by the Gore Clinical Research Department. All variables are reported descriptively. Categorical variables are expressed as percentage. Continuous variables are presented as mean ± standard deviation. All data were analyzed using statistical SAS software, version 9.2 of the SAS System for Windows (SAS Institute, Cary, NC). Morphologic characteristics and outcomes were classified according to the Society for Vascular Surgery Ad Hoc Committee on TEVAR reporting standards.10 Primary clinical success was reported on an intent-to-treat basis and requires successful deployment of the endovascular device at the intended location. Clinical data were prospectively recorded, and results are expressed as mean ± standard deviation for continuous variables and frequencies for the categorical ones.

RESULTS Three men and three women were treated; all were white patients. Mean age was 69 ± 10 years (range, 58-83 years). Comorbidities and risk factors are shown in Table I. The indication for TEVAR was atherosclerotic aneurysm (n ¼ 4; ruptured, n ¼ 1), complicated type A dissection (n ¼ 1, rupture; Fig 2), and pseudoaneurysm (n ¼ 1). Pseudoaneurysm was not mycotic but was due to a suture line disruption. Mean maximum aortic lesion diameter was 60 ± 14 mm (range, 39-77 mm). Proximal

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Fig 2. Preoperative computed tomography angiography (A) with multiplanar reconstruction (B) of a complicated ruptured acute type A aortic dissection. Postoperative (C) control with volume rendering three-dimensional reconstruction (D) after implantation of an ascending “off-the-shelf” thoracic stent graft (SG).

ascending aorta diameter at the proximal landing zone was 33 ± 5 mm (range, 27-40 mm); proximal neck length was 19 ± 0.5 mm (range, 12-25 mm), and distal neck length was 21 ± 1.4 mm (range, 0.7-40 mm). Urgent intervention was performed in three (50%) cases. Access vessels were approached surgically in all cases; the transfemoral route was used in four (67%) cases, and the remaining two required an iliac conduit. An additional branch vessel procedure was performed in one case (brachiocephalic chimney SG plus carotid to carotid bypass) for an atherosclerotic aneurysm. Standard SG was used in all cases, with a mean SG diameter of 38 ± 5 mm (range,

36-45 mm); Table II reports the different types of SGs used in the series. Primary clinical success was 100%. There was no TEVAR-related in-hospital mortality. Open conversion was never required. Complication, such as cerebrovascular accidents, valve impairment, or myocardial infarction, did not occur. All patients were discharged home alive, and mean hospital stay was 14 ± 8 days (range, 6-26 days). No patient was lost at a median follow-up of 26 months (range, 16-72 months); appropriate follow-up imaging was available for evaluation of four of six patients (67%) at 1 year and three of five patients (60%) at 5 years. During the follow-up, no patient died, and ongoing

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Table II. Type of stent grafts (SGs) Patient

Pathologic process

SG type (No.)

1

Aneurysm rupture

Thoracic (2)

2

Pseudoaneurysm

Abdominal (2)

SG size, diameter (mm)  length (cm)

Adjunctive procedure

45  20 þ 45  15

No

36  4.5

No

3

Aneurysm

Thoracic (1)

31  15

No

4

Dissection rupture

Thoracic (1)

40  10

No

37  20 þ 37  15

BCT chimney þ CCb

36  4.5

No

5

Aneurysm

Thoracic (2)

6

Aneurysm rupture

Abdominal (3)

BCT, Brachiocephalic trunk; CCb, carotid to carotid bypass.

primary clinical success was maintained in all patients. One patient required readmission because of acute myocardial infarction at postoperative day 318, which was not related to the device or the procedure. Reintervention was never required; endoleaks, migrations, fractures, or ruptures were not observed.

DISCUSSION TEVAR is a recent option for ascending aortic diseases, but its application is limited by anatomic landmarks, lack of devices designed to treat these pathologic processes, and impact of hemodynamic forces that are not yet completely elucidated.2 The GREAT experience confirms that this treatment is still confined to a limited number of lesions. This observation intrinsically confirms open repair as the “gold standard” treatment for ascending aortic diseases, but on the other hand, the absence of in-hospital mortality and the ongoing clinical and technical success support the encouraging results already reported in other experiences using TEVAR.3-7,11-16 In this high-risk cohort of patients, the absence of aortarelated mortality compares favorably with the 6.9% to 15.4% mortality rate for open repair reported by centers of excellence.17,18 Although it is still in its developing phase, TEVAR might be advocated as a viable option for managing high-risk patients in anatomically selected lesions. Nevertheless, concerns still remain in the long-term follow-up, for which results are limited.3,4 Complications such as type I endoleaks, strokes, aortic valve incompetence, SG migration, and overstenting of the head vessels have called into question the safety and efficacy of the procedure in this area.5-7,13 However, a recent meta-analysis reported promising results with no late conversions and a pooled reoperation rate of 8.9% that is similar to that of descending thoracic endovascular repair.4 Results from GREAT are encouraging, with no late conversion or TEVAR-related complications during the follow-up. These results were obtained with a nondedicated device to treat the ascending aorta, but support is found in the results of other multicenter or investigational sponsored device studies that reported uniform accuracy of deployment and secure fixation.13,15

Recent systematic reviews and meta-analyses showed that TEVAR offered a potential early advantage to patients at prohibitive risk for conventional open repair.3,4 Although the median follow-up of 26 months reported in six cases of the GREAT was not significantly longer than the median 22 months reported in the literature, most of the GREAT patients had consistent follow-up at the 5-year window. Second, despite that current ideal candidates for ascending TEVAR are reported to be patients with focal aortic defects, especially in the middle third of the ascending aorta, in the GREAT, TEVAR proved to be an effective treatment for various aortic diseases and clinical settings. Given the unavailability of dedicated SGs to date, the positive data in the GREAT seem to be the result of a careful anatomic selection criterion.2,5,6 Currently, one of the most important issues in ascending TEVAR is the lack of a dedicated device; that is still a work in progress for many manufacturers (https://www.gore.com/news-events/press-release/implantof-endovascular-stent-graft-ascending-aorta).13,15 Custommade devices have been implanted in very few cases so far, and most important, custom-made devices for ascending cases are limited by lengthy manufacturing time.19 Considering that urgent TEVAR in ascending cases has been described in the range of 30% to 75% in the largest series reported, it is not unexpected that standard abdominal SGs have been used to treat some cases.3,4,7,13,14,16 In particular, standard abdominal extenders have been used in GREAT to treat smaller aortas in urgent settings, such as rupture and pseudoaneurysm. Although abdominal extenders have not been designed to be used in the ascending aorta, one can exploit two helpful technologic aspects: the length of the delivery sheath and the length of the extender itself. If a short delivery sheath requires a different access than the femoral arteries, several aspects should be acknowledged. First, the right axillary artery allows a better adaptation of the SG deployment to the inner curve of the aorta.4 Second, both the axillary and the left subclavian arteries are less likely to be affected by obstructive disease, and they may serve as a rapid bailout site for cardiopulmonary bypass should the TEVAR need to be converted in open repair.3,4 Last but not least, the use of two or three

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stacked short SGs has been described to be a potential solution to match significantly different anatomic measures (proximal and distal neck within curvatures constrained within anatomic landmarks) as occurred in case of aneurysms.5 In this analysis, there are two major limitations: first, data come from a registry that did not collect information specific to TEVAR in the ascending aorta; and second, the number of patients is small. The advantages are that GREAT offers real-world data to be considered for daily practice, and follow-up continues within the registry up to 10 years.

CONCLUSIONS Preliminary real-world experience of ascending TEVAR shows satisfactory outcomes at short-term follow-up. Although concerns remain for off-label use of standard devices, TEVAR-related complications were not observed. Longer follow-up data are expected to confirm durability of these results. The authors are very grateful to Beth Tohill, MSPH, PhD, for the data acquisition and management.

AUTHOR CONTRIBUTIONS Conception and design: GP, CL, ST Analysis and interpretation: GP, VG, CL, WB, TN, MJ, ST Data collection: GP, VG, CL, WB, TN, MJ Writing the article: GP, VG, CL, ST Critical revision of the article: GP, VG, CL, WB, TN, MJ, ST Final approval of the article: GP, VG, CL, WB, TN, MJ, ST Statistical analysis: GP, CL, ST Obtained funding: Not applicable Overall responsibility: GP

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7. Roselli EE, Idrees J, Greenberg RK, Johnston DR, Lytle BW. Endovascular stent grafting for ascending aorta repair in high-risk patients. J Thorac Cardiovasc Surg 2015;149:144-51. 8. Loa J, Dubenec S, Cao P, Milner R, Silveira PG, Trimarchi S, et al. The Gore Global Registry for Endovascular Aortic Treatment: objectives and design. Ann Vasc Surg 2016;31:70-6. 9. Turina MI, Shennib H, Dunning J, Cheng D, Martin J, Muneretto C, et al; EACTS/ESCVS committee. EACTS/ESCVS best practice guidelines for reporting treatment results in the thoracic aorta. Eur J Cardiothorac Surg 2009;35:927-30. 10. Fillinger MF, Greenberg RK, McKinsey JF, Chaikof EL; Society for Vascular Surgery Ad Hoc Committee on TEVAR Reporting Standards. Reporting standards for thoracic endovascular aortic repair (TEVAR). J Vasc Surg 2010;52:1022-33. 11. Appoo JJ, Tse LW, Pozeg ZI, Wong JK, Hutchison SJ, Gregory AJ, et al. Thoracic aortic frontier: review of current applications and directions of thoracic endovascular aortic repair (TEVAR). Can J Cardiol 2014;30:52-63. 12. Bernardes RC, Navarro TP, Reis FR, Lima LC, Monteiro EL, Procopio RJ, et al. Early experience with off-the-shelf endografts using a zone 0 proximal landing site to treat the ascending aorta and arch. J Thorac Cardiovasc Surg 2014;148:105-12. 13. Tsilimparis N, Debus ES, Oderich GS, Haulon S, Terp KA, Roeder B, et al. International experience with endovascular therapy of the ascending aorta with a dedicated endograft. J Vasc Surg 2016;63:1476-82. 14. Vallabhajosyula P, Gottret JP, Bavaria JE, Desai ND, Szeto WY. Endovascular repair of the ascending aorta in patients at high risk for open repair. J Thorac Cardiovasc Surg 2015;149(Suppl):S144-50. 15. Khoynezhad A, Donayre CE, Walot I, Koopmann MC, Kopchok GE, White RA. Feasibility of endovascular repair of ascending aortic pathologies as part of an FDA-approved physician-sponsored investigational device exemption. J Vasc Surg 2016;63:1483-95. 16. Piffaretti G, Galli M, Lomazzi C, Franchin M, Castelli P, Mariscalco G, et al. Endograft repair for pseudoaneurysms and penetrating ulcers of the ascending aorta. J Thorac Cardiovasc Surg 2016;151:1606-14. 17. Etz CD, Plestis KA, Homann TM, Bodian CA, Di Luozzo G, Spielvogel D, et al. Reoperative aortic root and transverse arch procedures: a comparison with contemporaneous primary operations. J Thorac Cardiovasc Surg 2008;136: 860-7. 18. Di Eusanio M, Berretta P, Bissoni L, Petridis FD, Di Marco L, Di Bartolomeo R. Re-operations on the proximal thoracic aorta: results and predictors of short- and long-term mortality in a series of 174 patients. Eur J Cardiothorac Surg 2011;40:1072-6. 19. Piffaretti G, Cottini M, Carrafiello G, Castelli P, Beghi C, Mariscalco G. Endovascular repair of ascending aortic pseudoaneurysm with custom-designed endograft. Ann Thorac Surg 2015;100:e31-3.

Submitted Sep 3, 2018; accepted Jan 11, 2019.

Additional material for this article may be found online at www.jvascsurg.org.

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APPENDIX (online only). Collaborators. Rodrigo C. Bernardes, MD, and Ricardo J. Procopio, MD, Hospital das Clínicas da Universidade Federal de Minas Gerais (HC-UFMG), Belo Horizonte, Brazil Joel E. Schneider, MD, North Carolina Heart and Vascular, Raleigh, NC

Ali F. AbuRahma, MD, Department of Surgery, West Virginia University, Charleston, WV John A. Kaufman, MD, Department of Interventional Radiology, Oregon Health & Science University, Portland, Ore Benjamin J. Pearce, MD, Division of Vascular Surgery and Endovascular Therapy, University of Alabama at Birmingham, Birmingham, Ala