Early Outcome of Endovascular Treatment of Acute Traumatic Aortic Injuries: The Talent Thoracic Retrospective Registry
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1 Early Outcome of Endovascular Treatment of Acute Traumatic Aortic Injuries: The Talent Thoracic Retrospective Registry Marek P. Ehrlich, MD, Hervé Rousseau, MD, Robin Heijman, MD, Philippe Piquet, MD, Jean-Paul Beregi, MD, Christoph A. Nienaber, MD, Gottfried Sodeck, MD, and Rossella Fattori, MD Departments of Cardiothoracic Surgery and Emergency Medicine, University of Vienna, Vienna, Austria; Department of Radiology, Centre Hospitalier Universitaire, Hopital de Rangueil, Toulouse, France; Department of Cardiothoracic Surgery, St. Antonius Hospital, Nieuwegein, the Netherlands; Centre Hospitalier Universitaire, Hopital Sainte Marguerite, Marseille, Radiologie Vasculaire, Hopital Cardiologique CHRU de Lille, Lille, France; Department of Cardiology, University Hospital Rostock, Rostock, Germany; Cardiovascular Radiology, University Hospital S. Orsola, Bologna, Italy Background. Acute traumatic injury of the thoracic aorta (TAI) is a life-threatening complication in patients who sustain deceleration or crush injuries. This study was conducted to examine the results in patients who underwent endovascular repair with the Talent (Medtronic/AVE, Santa Rosa, CA) thoracic stent graft for acute traumatic injury. Methods. Out of 457 consecutive endograft patients, 41 (9%) were treated for traumatic aortic conditions. There were 36 males with a mean age of years. Mean aortic diameter at the time of intervention was 34 mm 9 (range, 20 to 70 mm). The mean length of covered aorta was 106 mm (range, 5 to 130 mm ) with only one stent graft used in 98% (40) of all cases. Median follow-up period for hospital survivors was 13 months (1.0 to 69.0 months). Results. Stent graft implantation was technically successful in all cases (100%). One patient died during hospitalization, yielding an overall in-hospital mortality rate of 2.4%. Procedural-related paraplegia was zero and a primary endoleak was observed in 1 patient. Postoperative complications occurred in 4 patients (3 respiratory failures, 1 multiorgan failure). No patient required conversion to open surgical repair. Conclusions. The treatment of acute traumatic injuries of the descending thoracic aorta with the Talent stent graft is a feasible and safe technique; it provides low morbidity and mortality rates in the early postoperative period, and early results are encouraging. However, longterm studies are worthwhile to evaluate the effectiveness and the durability of this procedure. (Ann Thorac Surg 2009;88: ) 2009 by The Society of Thoracic Surgeons Blunt trauma with thoracic aortic involvement remains a leading cause of mortality. Most of these patients arrive in the emergency room with multiple concomitant injuries and makes them, therefore, poor candidates for open surgery on the injured descending aorta. Reported mortality rates for conventional repair of traumatic aortic rupture reaches up to 50%, pulmonary complication, renal insufficiency, and especially postoperative paraplegia may occur in 15% to 45% of patients [1 5]. Since the first endovascular stent graft experience in an abdominal aortic aneurysm [6], many groups have started to investigate the feasibility of thoracic aortic aneurysmal repair with endovascular stent grafts (ESG) for various aortic pathologic conditions [7 10]. Over the last decade, endovascular techniques have revolutionized the management of descending thoracic aortic disease, with the benefit of exclusion of the pathologically altered aorta without Accepted for publication June 10, Presented at the Forty-fifth Annual Meeting of The Society of Thoracic Surgeons, San Francisco, CA, Jan 26 28, Address correspondence to Dr Ehrlich, Dept. of Cardio-Thoracic Surgery, University of Vienna, Währinger Gürtel 18-20, Vienna, A-1090, Austria; marek.ehrlich@meduniwien.ac.at. direct surgical exposure. Especially in patients with acute traumatic aortic injuries considered unsuitable candidates for open surgery due to severe comorbid conditions, ESG may offer an attractive and safe alternative approach for treating such aortic pathologic conditions [11, 12]. The Talent Thoracic Retrospective Registry (TTR) was designed to collect outcome data from patients who underwent endoluminal treatment with the Talent thoracic stent graft (Medtronic/AVE, Santa Rosa, CA) in seven European referral centers [13]. The present subanalysis of the TTR registry comprises only data on patients subjected to endovascular stent graft placement for acute traumatic aortic injuries. Patients and Methods Enrollment The current analysis from the TTR registry is focused on 41 consecutive patients who underwent endovascular repair Dr Heijman discloses a financial relationship with Medtronic by The Society of Thoracic Surgeons /09/$36.00 Published by Elsevier Inc doi: /j.athoracsur
2 Ann Thorac Surg EHRLICH ET AL 2009;88: ENDOVASCULAR TREATMENT OF ATI: THE TTR 1259 Table 1. Demographics and Clinical Characteristics (n 41) Characteristics No. % Male Age, y (median) 34 (22 82) ASA score Comorbidity: Hypertension 4 10 Marfan syndrome 0 0 Renal insufficiency 0 0 COPD 4 10 Smoking 7 17 Maximum aortic diameter (mean SD, range ) ( mm) ASA American Society of Anesthesiologists; obstructive pulmonary disease. COPD chronic with the Talent thoracic stent graft for acute traumatic aortic injuries between November 1996 and March This subgroup represents 9% from a total of 457 patients with thoracic aortic pathology collected for the TTR registry. Seven European referral centers (Bologna, Lille, Marseille, Nieuwegein, Rostock, Toulouse, and Vienna) provided data from patients treated consecutively, with a minimum of 1-year follow-up. The TTR registry was approved by the local ethical committee of each participant center. Follow-up analysis was formed on clinical and imaging findings until the last visit and includes all adverse events. Data were collected on case report forms and checked for inconsistencies. In case of discrepancies, the attending investigator was queried to ensure appropriate interpretation of events. Table 2. Procedural Detail and 30-day Outcome Variable No. (%) Procedural success 41 (100) Length of covered aorta, mm (mean SD) Number of stent grafts deployed 42 One per person 40 (98) Two per person 2 (2) Occlusion of left subclavian artery 8 (19) Early mortality: 30-day mortality 1 (2) Procedural failure and redo intervention: Conversion to open surgery 0 (0) Primary endoleak 1 (2) Early complications: Neurological 0 (0) Stroke 0 (0) Spinal cord ischemia 0 (0) Respiratory failure 3 (7) Multiorgan failure 1 (2) Length of hospital stay (days) median, IQR (days) 15 (8 27) IQR interquartile range. Patient Characteristics The traumatic subgroup of TTR comprises 36 male and 5 female patients with an age of years, ranging from 18 to 71 years (Table 1). The American Society of Anesthesiologists (ASA) classification greater than class III was present in all cases (100%). None of the patients had undergone previous aortic surgery or endovascular repair. Comorbid medical conditions comprised hypertension (n 4, 10%) and chronic obstructive pulmonary disease (n 4, 10%). None of the treated patients had Fig 1. Postoperative computed tomographic scan of a patient after traumatic aortic injury.
3 1260 EHRLICH ET AL Ann Thorac Surg ENDOVASCULAR TREATMENT OF ATI: THE TTR 2009;88: Definitions Procedural success was defined as successful deployment of the stent graft device. Primary success was defined as complete exclusion of the injured side without any additional intervention. Secondary success was defined as complete exclusion of the aneurysm after secondary intervention. Endoleak was defined as radiologic evidence of blood flow outside the stent graft and was classified as primary (diagnosed within 30 days of endovascular repair) or secondary (diagnosed more than 30 days after intervention). Statistical Analysis Continuous data are presented as the median and interquartile range (range from the 25th to the 75th percentile) or the median and the 95% confidence interval [CI] as appropriate. Discrete data are given as counts and percentages. Univariate comparisons of continuous data were performed by Mann-Whitney U tests. Groups of categoric data were compared by Fisher exact tests with Yates correction. Mantel-Cox regression analysis for survival was performed according to standard procedures. A two-sided p value below 0.05 was considered statistically significant. Calculations were performed with SPSS for Mac version 16.0 (SPSS Inc, Chicago, IL). Fig 2. Kaplan-Meier survival curve. Marfan syndrome. All patients were treated within 14 days of traumatic injury. Cause of traumatic injury was traffic accident in 32 patients (78%) followed by occupational accident in 5 patients (12%) and high elevation fall in the remaining 4 patients (10%). Device Description The Talent Thoracic stent graft is composed of Dacron graft fabric supported by self-expanding nitinol springs. The springs are sewn to the graft material with polyester sutures. The graft material is a sheet of monofilament polyester with a seam joining the edges to create a cylindrical tube. The connecting bar provides columnar strength to the device and facilitates deployment. All Talent stent grafts in that study had uncovered springs proximally and the smallest graft size was 22 mm. Preintervention Imaging Before endovascular treatment, all patients were examined by at least one tomographic imaging modality. Computed tomography (CT) (Fig 1) or magnetic resonance imaging (MRI) was preferred. In some specific cases angiography or transesophageal echocardiography (TEE) were performed additionally. Contrast enhanced CT was the most frequently used diagnostic method (95%), followed by angiography (37%), TEE (17%), and MRI (5%). All operations were performed under general anesthesia in the radiology suite under fluoroscopy control by a C-arm image intensifier. The technique of stent graft insertion has been described before [13]. Results There was no intraprocedural death and success deployment of the stent graft was obtained in all cases (100%) (Table 2). Furthermore, there were no access complications. Median length of covered aorta was 102 mm (100 to 115 mm) with only one stent graft used in 40 patients (98%). Mean aortic diameter at the time of intervention was measured 34 mm (range, 20 to 70 mm). In 8 patients (19%), the stent graft was positioned in the distal arch with coverage of the left subclavian artery to extend the proximal landing zone. In none of these 8 patients was a carotidsubclavian bypass performed prior to stent graft placement. One patient died during hospitalization due to multiorgan failure, yielding an overall in-hospital mortality rate of 2.4%. Procedural related paraplegia was zero and none of the patients experienced stroke or other major stent graft-related complications. Incomplete exclusion of the thoracic aortic pathology after the stent graft procedure was only observed in 1 case. This patient had a type Ia endoleak and an additional stent graft was positioned at the proximal landing zone right during the same procedure with complete sealing of the leak. Postoperative complications occurred in 4 patients (3 respiratory failures, 1 multiorgan failure). No patient required early conversion to open surgical repair. Follow-Up Mean follow-up period for hospital survivors was 13 months (range, 1 to 69 month). A reduction of the involved aortic segment was detected in 77% of all patients ( mm for follow-up mean diameter versus mm for preoperative mean diameter) and in the remaining 9 patients (23%) the aortic diameter remained stable during follow-up. There was no late death related to the stent graft procedure and no late complications or endoleaks. Kaplan-Meier overall survival rate was 100% at 12, 24, and 36 months (Fig 2). Comment Acute thoracic aortic injury (TAI) may be a life threatening complication after blunt chest trauma and a leading
4 Ann Thorac Surg EHRLICH ET AL 2009;88: ENDOVASCULAR TREATMENT OF ATI: THE TTR 1261 cause of mortality. Recent investigations have shown that TAI occurs in 10% to 30% of adults sustaining fatal blunt trauma [14, 15]. It therefore represents one of the most common causes of death at the scene of vehicular accidents, accounting for 8,000 victims per year in the United States. The more sophisticated prehospital care and the proliferation of rapid transport for patients have resulted in an average increase in the number of patients treated. The lesion may be generated by many different types of sudden-deceleration injury, including car and motorcycle collisions, falls from a height or blast injuries, airplane and train crashes, skiing, and equestrian accidents. The region subjected to the greatest strain is put upon the isthmus, where the relatively mobile thoracic aorta joins the fixed arch and the insertion of the ligamentum arteriosum. Aortic ruptures occur at this site in 80% of the pathologic series and in 90% to 95% of the clinical series [1, 14 16]. Up to 80% of these patients die at the scene of the accident and for those who reach the hospital the estimated rate of mortality is around 30% [17]. In most of these cases, a complete transection of the aorta at the isthmus site occurs, which leads to sudden death due to exsanguination. In those who survive the initial period, antihypertensive medication is imperative to reduce wall stress and the risk of aortic rupture. Surgical repair of these aortic lesions has been the gold standard for many decades but was and still is associated with significant morbidity as well as mortality rates. Several studies have reported operative mortalities from 10% to 54% with spinal cord injuries in up to 35% of all patients [2, 3]. During the last two decades, treatment of the descending aorta with a stent graft device for a variety of pathologic conditions (such as aneurysmal dilatations, acute type B dissections, or penetrating ulcers) has become a viable option and an alternative treatment modality to open surgical repair [13]. Especially patients after blunt trauma presenting with associated thoracic aortic injury are excellent candidates for such a less invasive procedure for a number of reasons. Pulmonary complications associated with thoracotomy can be prevented; cardiopulmonary bypass necessitating the use of heparin for surgical aortic reconstruction can be completely avoided. Furthermore, this procedure can be performed in the acute phase without physiologic stress on the unstable patient. This analysis focuses on 41 patients with acute traumatic aortic injuries extracted from the TTR registry and demonstrates that endovascular repair using the Talent stent graft is feasible and has low incidence of associated complications. All these patients arrived in the hospital with signs of hemodynamic instability, uncontrolled blood pressure, and signs of other vital organ dysfunctions. Imaging findings showed clear signs of impending rupture, periaortic hematoma, hemothorax, or rapid growth of the pseudoaneurysm. They received the stent graft within 14 days after the traumatic incidence. Technical success was obtained in all patients who underwent this approach and hospital mortality was as low as 2% in this series. This finding is consistent with previous series of similar size [18 20]. Extrapolating this small group of 41 patients from the whole TTR, which was comprised of 457 patients who have been treated with this device for a variety of other pathologic conditions, this type of aortic lesion resulted in the lowest mortality and morbidity rate [21]. Furthermore, although the number of patients was small, midterm results were excellent. These findings can be explained by the fact that most of these patients are of younger age and have no other comorbidities that might influence short as well as midterm outcome. Not surprisingly, a very low rate of primary and secondary endoleaks could be observed in this series. This can be explained by the good wall condition at the deployment site with no atherosclerotic changes. Furthermore, none of the patients needed early as well as late conversion to conventional open surgery due to stent graft procedural failure. With regard to spinal cord injury, none of our patients developed paraplegia after the stent graft procedure and this observation is consistent with several other studies [19, 22]. This phenomenon can be explained due to the short length of covered aortic segment. It has been shown that the threshold for increased risk of paraplegia appears to be at around 200 mm [23]. Forty out of the 41 patients treated in this study (98%) received only one stent graft, with a mean length of aortic coverage of 106 mm. With regard to a short proximal neck for placing the stent graft in the descending aorta, a number of different approaches have been described in the literature including intentional left subclavian overstenting, coil embolization, or preoperative subclavian-carotid bypass surgery [24]. In this series, the left subclavian origin was covered in 8 of the 41 patients (19%) and there was no incidence of postoperative neurologic sequelae such as stroke or left arm ischemia. In spite of many benefits on the short-term and midterm outcomes, the long-term results of endovascular repair remain a major issue in relatively young patients and some particular anatomic conditions need to be present to perform this kind of procedure. First of all, a proper peripheral vascular access of at least 7 to 8 mm of diameter is necessary, but this condition is not always present, particularly in younger patients. Second, the most important anatomic characteristic of any lesion allowing endovascular treatment is the presence of an adequate proximal neck. The aortic isthmus is usually very close to the left subclavian artery and sometimes the lesion in contiguity or with a limited distance from the vessel. Proximal apposition is also an important issue for long-term stability, because individual case reports of stent graft collapse resulting in major morbidity and mortality and the need for reintervention have been reported with several different devices. In this study, the stent graft had proximal uncovered springs proximally insuring a better apposition of the proximal seal zone to the inner curvature of a tight aortic arch. Another issue is the need for smaller diameter devices in these younger patients whose aortas have not begun to dilate.
5 1262 EHRLICH ET AL Ann Thorac Surg ENDOVASCULAR TREATMENT OF ATI: THE TTR 2009;88: In conclusion, the treatment of acute traumatic injuries of the descending thoracic aorta with the Talent stent graft is a feasible and safe technique and provides low morbidity and mortality rates in the early postoperative period. Early outcome results are encouraging; however, long-term studies with larger number of cases are needed to evaluate the effectiveness and the durability of this procedure. The major limitation of the present study was that all data was analyzed retrospectively, a process which mandates caution in the interpretation of the results. For example, there is a lack of endograft-exclusion criteria as well as a lack of number of patients who had been treated within the same time interval conventionally. Furthermore, a number of variables, such as proximal and distal neck diameter, access of conduit diameters were not available in this registry. In addition, the specific details on other related injuries which resulted from the trauma are unknown due to the fact that this study was performed retrospectively. However, it is known that all patients had an ASA greater than 3. References 1. Hunt JP, Baker CC, Lentz CW, et al. Thoracic aorta injuries: management and outcome of 144 patients. J Trauma 1996;40: Fabian TC, Richardson JD, Croce MA, et al. Prospective study of blunt aortic injury: multicenter trial of the American Association for the Surgery of Trauma. J Trauma 1997;42: von Oppell UO, Dunne TT, De Groot MK, Zilla P. Traumatic aortic rupture: twenty-year meta-analysis of mortality and risk of paraplegia. Ann Thorac Surg 1994;58: Rousseau H, Dambrin C, Marcheix B, et al. Acute traumatic aortic rupture: a comparison of surgical and stent-graft repair. J Thorac Cardiovasc Surg 2005;129: Buz S, Zipfel B, Mulahasanovic S, Pasic M, Weng Y, Hetzer R. Conventional surgical repair and endovascular treatment of acute traumatic aortic rupture. Eur J Cardiothorac Surg 2008;33: Parodi JC, Palmaz JC, Barone HD. Transfemoral intraluminal graft implantation for abdominal aortic aneurysms. Ann Vasc Surg 1991;5: Dake MD, Miller DC, Semba CP, Mitchell RS, Walker PJ, Liddell RP. Transluminal placement of endovascular stentgrafts for the treatment of descending thoracic aortic aneurysms. N Engl J Med 1994;331: Inoue KI, Iwase T, Sato M, et al. Clinical application of transluminal endovascular graft placement for aortic aneurysms. Ann Thorac Surg 1997;63: Mitchell RS, Miller DC, Dake MD, Semba CP, Moore KA, Sakai T. Thoracic aortic aneurysm repair with an endovascular stent graft: the first generation. Ann Thorac Surg 1999;67: Mitchell RD, Dake MD, Semba CP, et al. Endovascular stent graft repair of thoracic aortic aneurysms. J Thoracic Cardiovasc Surg 1996;111: Amabile P, Collart F, Gariboldi V, Rollet G, Bartoli JM, Piquet P. Surgical versus endovascular treatment of traumatic thoracic aortic rupture. J Vasc Surg 2004;40: Czermak BV, Waldenberger P, Perkmann R, et al. Placement of endovascular stent grafts for emergency treatment of acute disease of the descending thoracic aorta. AJR Am J Roentgenol 2002;179: Fattori R, Nienaber CA, Rousseau H, et al. Results of endovascular repair of the thoracic aorta with the Talent Thoracic stent graft: the Talent Thoracic Retrospective Registry. J Thorac Cardiovasc Surg 2006;132: Richens D, Kotidis K, Neale M, Oakley C, Fails A. Rupture of the aorta following road traffic accidents in the United Kingdom The results of the co-operative crash injury study. Eur J Cardiothoracic Surg 2003;23: Bertrand S, Cuny S, Petit P, et al. Traumatic rupture of thoracic aorta in real-world motor vehicle crashes: Traffic Inj Prev 2008;9: Arajärvi E, Santavirta S, Tolonen J. Aortic ruptures in seat belt wearers; J Thorac Cardiovasc Surg 1989;98: Avery JE, Hall DP, Adams JE, Headrick JR, Nipp RN. Traumatic rupture of the aorta. South Med J 1979;72: Fattori R, Russo V, Lovato L, Di Bartolomeo R. Optimal management of traumatic aortic injury. Eur J Vasc Endovasc Surg 2009;37: Lachat M, Pfammatter T, Witzke H, et al. Acute traumatic aortic rupture: early stent-graft repair: Eur J Cardiothorac Surg 2002;21: Peterson BG, Matsumara JS, Morasch MD, West MA, Eskandari MK. Percutaneous endovascular repair of blunt thoracic transaction. J Trauma 2005;59: Kische S, Ehrlich MP, Nienaber CA, et al. Endovascular treatment of acute and chronic aortic dissection: midterm results from the Talent Thoracic Retrospective Registry. J Thorac Cardiovasc Surg 2009;138: Day CP, Buckenham TM. Outcomes of endovascular repair of acute thoracic Aortic injury: interrogation of the New Zealand thoracic aortic stent database (NZ TAS). Eur J Vasc Endovasc Surg 2008;36: Amabile P, Grisold D, Giorgi R, Bartoli JM, Piquet P. Incidence and determinants of spinal cord ischemia in stentgraft repair of the thoracic aorta, Eur J Vasc Endovasc Surg 2008;35: Weigang E, Luehe M, Harloff A, et al. Incidence of neurological complications following overstenting of the left subclavian artery. Eur J Cardiothorac Surg 2007;31: DISCUSSION DR JEHANGIR APPOO (Calgary, Canada): Thank you for your nice presentation. What we ve noticed in these young patients, when we see them afterwards in the clinic, is for some reason we find these patients are hypertensive and all these twenty- and thirty-year-olds are on medications to control their blood pressure. And I was wondering if you ve seen this postoperatively, if this has to do with compliance of the aorta and the pressure wave bouncing off the stent grafts. But we ve seen patients do well, who are healthy, but now you have twenty- and thirtyyear-olds on antihypertensive medication. DR EHRLICH: I cannot speak for all of the centers, but generally speaking, in Vienna we did not see the phenomenon of these young patients developing hypertension after the stent graft procedure. DR APPOO: Sorry, I think maybe you didn t understand my question. Once the cases do well and they go home, and in ongoing follow-up, we find that these patients are still hypertensive. And these are patients you would not otherwise expect to have hypertension because they re generally otherwise
6 Ann Thorac Surg EHRLICH ET AL 2009;88: ENDOVASCULAR TREATMENT OF ATI: THE TTR 1263 healthy twenty- or thirty-year-olds who have been in car accidents. Have you seen that? Because I find that a lot of these patients I see postoperatively now have to be treated with antihypertensive medication. DR EHRLICH: Are you saying that there is a sort of coarctation situation occurring? DR APPOO: Well, you know, yes. We CT [computed tomography] them and you worry about that, and there are absolutely no coarct at all and they have good peripheral perfusion. There is a theory out there that maybe the stent grafts proximally, the pressure wave and the dynamics of the blood flow changes. Any comments. DR EHRLICH: Well, we haven t seen that, so I cannot comment. DR JOSEPH BAVARIA (Philadelphia, PA): You have a great deal of experience with the Talent graft for transections and it s being used more and more. Would you like to make a comment on technique, ballooning, not ballooning, risk of antegrade dissection, et cetera. DR EHRLICH: Well, first of all, the right timing for the stent graft approach is crucial, some centers balloon, some don t, and in none of these patients a dissection was observed after the procedure. DR BAVARIA: Do you have long-term follow-up? DR EHRLICH: No, unfortunately not and this is the major pitfall of this multicenter study, that it s actually only a retrospective observational one. DR BAVARIA: So these patients are not being followed long term, right? DR EHRLICH: Well, some of them are. But, not in the registry anymore. DR BAVARIA: Do you have the average diameter of the stent you used? DR EHRLICH: It s 24 mm.
Thoracic aortic trauma A.T.O.ABDOOL-CARRIM ACADEMIC HEAD VASCULAR SURGERY DEPARTMENT OF SURGERY UNIVERSITY OF WITWATERSRAND
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