Endovascular devices for thoracic aortic repair
- Ronald M Fairman, MD
Ronald M Fairman, MD
- Professor of Surgery and Radiology
- University of Pennsylvania School of Medicine
- Rabih A Chaer, MD
Rabih A Chaer, MD
- Professor of Surgery
- The University of Pittsburgh School of Medicine
- Section Editors
- Joseph L Mills, Sr, MD
Joseph L Mills, Sr, MD
- Section Editor — Vascular and Endovascular Surgery
- Professor and Chief
- Division of Vascular Surgery and Endovascular Therapy
- Baylor College of Medicine
- John F Eidt, MD
John F Eidt, MD
- Section Editor — Vascular and Endovascular Surgery
- Professor of Surgery, Texas A&M Health Science Center
- Vice Chair of Vascular Surgical Services, Baylor Heart and Vascular Hospital at Dallas
Thoracic endovascular aortic repair (TEVAR) is becoming increasingly popular due to reduced perioperative morbidity and mortality compared with open surgical repair . Although TEVAR was developed for the treatment of degenerative aneurysmal disease, other pathologies can be treated using these devices including aortic dissection, aortic transection, intramural hematoma and penetrating aortic ulcer [1,2]. Endovascular aortic repair requires that specific anatomic criteria be fulfilled, and, for those with appropriate anatomy, this technique allows the treatment of patients who might not otherwise be candidates for aortic repair. Advanced endovascular aortic devices that allow flow into specific aortic branches depending upon the level of repair (eg, innominate, left subclavian, renal artery, internal iliac artery) are available to treat more complex anatomy.
The placement of aortic endografts is associated with device-related complications that can include component disconnection, stent-graft buckling and migration over time often due to disease progression (eg, aortic dissection). In the thoracic aorta, secondary intervention is needed in 10 to 60 percent of patients, more commonly in patients undergoing endovascular repair of thoracic dissection and more complicated hybrid repairs [3-5]. As such, these devices require lifelong surveillance; the long-term outcomes continue to be studied.
The specific devices available for endovascular repair of the thoracic aorta will be reviewed here. The indications for, placement of, and complications of these devices are discussed elsewhere. (See "Endovascular repair of the thoracic aorta" and "Complications of endovascular abdominal aortic repair".)
The aorta is the major arterial conduit conveying blood from the heart to the systemic circulation. It originates immediately beyond the aortic valve ascending initially. Then it curves forming the aortic arch, and descends caudally adjacent the spine. The ascending thoracic aorta gives off the coronary arteries. The aortic arch branches are typically the brachiocephalic trunk (branches to the right common carotid and right subclavian arteries), left common carotid and left subclavian arteries; however, aortic arch anatomy is variable (figure 1).
The descending thoracic aorta provides paired thoracic arteries (T1-T12) and continues through the hiatus of the diaphragm to become the abdominal aorta which extends retroperitoneally to its bifurcation into the common iliac arteries at the level of the fourth lumbar vertebra (figure 2). The abdominal aorta lies slightly left of the midline to accommodate the inferior vena cava which is in close apposition. The branches of the aorta (superior to inferior) include the left and right inferior phrenic arteries, left and right middle suprarenal arteries, the celiac axis, superior mesenteric artery, left and right renal arteries, left and right internal spermatic arteries, inferior mesenteric artery, left and right common iliac artery, middle sacral artery and the paired lumbar arteries (L1-L4).
- Murad MH, Rizvi AZ, Malgor R, et al. Comparative effectiveness of the treatments for thoracic aortic transection [corrected]. J Vasc Surg 2011; 53:193.
- Clough RE, Mani K, Lyons OT, et al. Endovascular treatment of acute aortic syndrome. J Vasc Surg 2011; 54:1580.
- Geisbüsch P, Hoffmann S, Kotelis D, et al. Reinterventions during midterm follow-up after endovascular treatment of thoracic aortic disease. J Vasc Surg 2011; 53:1528.
- Manning BJ, Dias N, Ohrlander T, et al. Endovascular treatment for chronic type B dissection: limitations of short stent-grafts revealed at midterm follow-up. J Endovasc Ther 2009; 16:590.
- Eggebrecht H, Nienaber CA, Neuhäuser M, et al. Endovascular stent-graft placement in aortic dissection: a meta-analysis. Eur Heart J 2006; 27:489.
- Sandhu RS, Pipinos II. Isolated iliac artery aneurysms. Semin Vasc Surg 2005; 18:209.
- Kiguchi M, Chaer RA. Endovascular repair of thoracic aortic pathology. Expert Rev Med Devices 2011; 8:515.
- Gawenda M, Brunkwall J. Comparison of CE approved TEVAR devices. J Cardiovasc Surg (Torino) 2010; 51:157.
- Lin PH, El Sayed HF, Kougias P, et al. Endovascular repair of thoracic aortic disease: overview of current devices and clinical results. Vascular 2007; 15:179.
- http://www.goremedical.com/contentTypeDetail.jsp?action=contentDetail&N=8083 8239&contenttype=8327&R=1234725569231 (Accessed on March 21, 2012).
- Melissano G, Tshomba Y, Civilini E, Chiesa R. Disappointing results with a new commercially available thoracic endograft. J Vasc Surg 2004; 39:124.
- Cho JS, Haider SE, Makaroun MS. Endovascular therapy of thoracic aneurysms: Gore TAG trial results. Semin Vasc Surg 2006; 19:18.
- Makaroun MS, Dillavou ED, Kee ST, et al. Endovascular treatment of thoracic aortic aneurysms: results of the phase II multicenter trial of the GORE TAG thoracic endoprosthesis. J Vasc Surg 2005; 41:1.
- http://www.goremedical.com/contentTypeDetail.jsp?action=contentDetail&N=8083 8239&contenttype=8327&R=1276629378975 (Accessed on March 21, 2012).
- Kasirajan K. New C-TAG device and overcome of compression events. J Cardiovasc Surg (Torino) 2012; 53:169.
- TEVAR using the redesigned TAG device (CTAG) for Traumatic Aortic Transection: A non-randomized multicenter trial. http://scvs.org/symposium/abstracts/2012/12.cgi (Accessed on January 30, 2012).
- Mockrin SC, Byers LD, Koshland DE Jr. Subunit interactions in yeast glyceraldehyde-3-phosphate dehydrogenase. Biochemistry 1975; 14:5428.
- Melissano G, Tshomba Y, Rinaldi E, Chiesa R. Initial clinical experience with a new low-profile thoracic endograft. J Vasc Surg 2015; 62:336.
- Illig KA, Ohki T, Hughes GC, et al. One-year outcomes from the international multicenter study of the Zenith Alpha Thoracic Endovascular Graft for thoracic endovascular repair. J Vasc Surg 2015; 62:1485.
- Lee WA, Martin TD, Hess PJ Jr, et al. First United States experience of the TX2 Pro-Form thoracic delivery system. J Vasc Surg 2010; 52:1459.
- http://www.cookmedical.com/ai/content/mmedia/AI-BM-TX2PFCOI-EN-200909.pdf (Accessed on March 21, 2012).
- http://www.accessdata.fda.gov/cdrh_docs/pdf14/P140016b.pdf (Accessed on February 10, 2017).
- Matsumura JS, Cambria RP, Dake MD, et al. International controlled clinical trial of thoracic endovascular aneurysm repair with the Zenith TX2 endovascular graft: 1-year results. J Vasc Surg 2008; 47:247.
- Greenberg RK, O'Neill S, Walker E, et al. Endovascular repair of thoracic aortic lesions with the Zenith TX1 and TX2 thoracic grafts: intermediate-term results. J Vasc Surg 2005; 41:589.
- Lombardi JV, Cambria RP, Nienaber CA, et al. Prospective multicenter clinical trial (STABLE) on the endovascular treatment of complicated type B aortic dissection using a composite device design. J Vasc Surg 2012; 55:629.
- Melissano G, Bertoglio L, Kahlberg A, et al. Evaluation of a new disease-specific endovascular device for type B aortic dissection. J Thorac Cardiovasc Surg 2008; 136:1012.
- Mossop P, Nixon I, Oakes J, et al. Immediate "total" aortic true lumen expansion in type A and B acute aortic dissection after endovascular aortic endografting and GZSD bare stenting. J Thorac Cardiovasc Surg 2007; 134:1360.
- Thompson M, Ivaz S, Cheshire N, et al. Early results of endovascular treatment of the thoracic aorta using the Valiant endograft. Cardiovasc Intervent Radiol 2007; 30:1130.
- Fairman RM, Tuchek JM, Lee WA, et al. Pivotal results for the Medtronic Valiant Thoracic Stent Graft System in the VALOR II trial. J Vasc Surg 2012; 56:1222.
- Funovics M, Blum M, Langenberger H, et al. Endovascular repair of the descending aorta and the aortic arch with the Relay stent graft. Ann Thorac Surg 2009; 88:637.
- Riambau V, Zipfel B, Coppi G, et al. Final operative and midterm results of the European experience in the RELAY Endovascular Registry for Thoracic Disease (RESTORE) study. J Vasc Surg 2011; 53:565.
- Riambau V, RESTORE collaborators. European experience with Relay: a new stent graft and delivery system for thoracic and arch lesions. J Cardiovasc Surg (Torino) 2008; 49:407.
- Zipfel B, Czerny M, Funovics M, et al. Endovascular treatment of patients with types A and B thoracic aortic dissection using Relay thoracic stent-grafts: results from the RESTORE Patient Registry. J Endovasc Ther 2011; 18:131.
- Inglese L, Mollichelli N, Medda M, et al. Endovascular repair of thoracic aortic disease with the EndoFit stent-graft: short and midterm results from a single center. J Endovasc Ther 2008; 15:54.
- Qu L, Raithel D. Two-year single-center experience with thoracic endovascular aortic repair using the EndoFit thoracic stent-graft. J Endovasc Ther 2008; 15:530.
- Bergeron P, Inglese L, Gay J, Dedicated Registry Collaborators. Setting up of a multicentric European registry dealing with type B dissections in chronic and acute phases with thoracic EndoFit devices. J Cardiovasc Surg (Torino) 2007; 48:689.
- Zipfel B, Buz S, Hammerschmidt R, et al. Early clinical experience with the E-vita thoracic stent-graft system: a single center study. J Cardiovasc Surg (Torino) 2008; 49:417.
- Uchida N, Katayama A, Higashiue S, et al. A new device as an open stent graft for extended aortic repair: a multicentre early experience in Japan. Eur J Cardiothorac Surg 2016; 49:1270.
- Stefanov F, Morris L, Elhelali A, et al. Insights from complex aortic surgery with a Streamliner device for aortic arch repair (STAR). J Thorac Cardiovasc Surg 2016; 152:1309.
- Hynes N, Sultan S, Elhelali A, et al. Systematic Review and Patient-Level Meta-analysis of the Streamliner Multilayer Flow Modulator in the Management of Complex Thoracoabdominal Aortic Pathology. J Endovasc Ther 2016; 23:501.
- Vaislic CD, Fabiani JN, Chocron S, et al. One-year outcomes following repair of thoracoabdominal aneurysms with the multilayer flow modulator: report from the STRATO trial. J Endovasc Ther 2014; 21:85.
- Sultan S, Hynes N, Sultan M, MFM Collaborators. When not to implant the multilayer flow modulator: lessons learned from application outside the indications for use in patients with thoracoabdominal pathologies. J Endovasc Ther 2014; 21:96.
- Vaislic CD, Fabiani JN, Chocron S, et al. Three-Year Outcomes With the Multilayer Flow Modulator for Repair of Thoracoabdominal Aneurysms: A Follow-up Report From the STRATO Trial. J Endovasc Ther 2016; 23:762.
- Fairman RM, Criado F, Farber M, et al. Pivotal results of the Medtronic Vascular Talent Thoracic Stent Graft System: the VALOR trial. J Vasc Surg 2008; 48:546.
- Nienaber CA, Rousseau H, Eggebrecht H, et al. Randomized comparison of strategies for type B aortic dissection: the INvestigation of STEnt Grafts in Aortic Dissection (INSTEAD) trial. Circulation 2009; 120:2519.
- Tambyraja AL, Fishwick NG, Bown MJ, et al. Fenestrated aortic endografts for juxtarenal aortic aneurysm: medium term outcomes. Eur J Vasc Endovasc Surg 2011; 42:54.
- Greenberg RK, Sternbergh WC 3rd, Makaroun M, et al. Intermediate results of a United States multicenter trial of fenestrated endograft repair for juxtarenal abdominal aortic aneurysms. J Vasc Surg 2009; 50:730.
- Amiot S, Haulon S, Becquemin JP, et al. Fenestrated endovascular grafting: the French multicentre experience. Eur J Vasc Endovasc Surg 2010; 39:537.
- Greenberg RK, Haulon S, O'Neill S, et al. Primary endovascular repair of juxtarenal aneurysms with fenestrated endovascular grafting. Eur J Vasc Endovasc Surg 2004; 27:484.
- O'Neill S, Greenberg RK, Haddad F, et al. A prospective analysis of fenestrated endovascular grafting: intermediate-term outcomes. Eur J Vasc Endovasc Surg 2006; 32:115.
- Verhoeven EL, Vourliotakis G, Bos WT, et al. Fenestrated stent grafting for short-necked and juxtarenal abdominal aortic aneurysm: an 8-year single-centre experience. Eur J Vasc Endovasc Surg 2010; 39:529.
- Semmens JB, Lawrence-Brown MM, Hartley DE, et al. Outcomes of fenestrated endografts in the treatment of abdominal aortic aneurysm in Western Australia (1997-2004). J Endovasc Ther 2006; 13:320.
- Anderson JL, Berce M, Hartley DE. Endoluminal aortic grafting with renal and superior mesenteric artery incorporation by graft fenestration. J Endovasc Ther 2001; 8:3.
- Kristmundsson T, Sonesson B, Malina M, et al. Fenestrated endovascular repair for juxtarenal aortic pathology. J Vasc Surg 2009; 49:568.
- Ziegler P, Avgerinos ED, Umscheid T, et al. Fenestrated endografting for aortic aneurysm repair: a 7-year experience. J Endovasc Ther 2007; 14:609.
- Scurr JR, Brennan JA, Gilling-Smith GL, et al. Fenestrated endovascular repair for juxtarenal aortic aneurysm. Br J Surg 2008; 95:326.
- Bicknell CD, Cheshire NJ, Riga CV, et al. Treatment of complex aneurysmal disease with fenestrated and branched stent grafts. Eur J Vasc Endovasc Surg 2009; 37:175.
- Greenberg RK, Qureshi M. Fenestrated and branched devices in the pipeline. J Vasc Surg 2010; 52:15S.
- Wang ZG, Li C. Single-branch endograft for treating stanford type B aortic dissections with entry tears in proximity to the left subclavian artery. J Endovasc Ther 2005; 12:588.
- Chuter TA, Hiramoto JS, Park KH, Reilly LM. The transition from custom-made to standardized multibranched thoracoabdominal aortic stent grafts. J Vasc Surg 2011; 54:660.
- Sweet MP, Hiramoto JS, Park KH, et al. A standardized multi-branched thoracoabdominal stent-graft for endovascular aneurysm repair. J Endovasc Ther 2009; 16:359.
- AORTIC ANATOMY
- BASIC PRINCIPLES
- Delivery system
- Main device
- THORACIC DEVICES
- TAG and CTAG
- TX2 and Alpha
- Valiant Thoracic Stent-Graft System
- Investigational and withdrawn devices
- - TAArget
- - E-Vita
- - Streamliner Multilayer Flow Modulator
- - Withdrawn - Talent Thoracic Stent-Graft System
- TEVAR TRIALS
- ADVANCED DEVICES
- Fenestrated grafts
- Branched grafts
- CHOICE OF DEVICE
- SUMMARY AND RECOMMENDATIONS