Thoracic aortic aneurysms are life threatening and

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1 Thoracic Aortic Aneurysms: Treatment With Endovascular Self-Expandable Stent Grafts Martin Grabenwöger, MD, Doris Hutschala, MD, Marek P. Ehrlich, MD, Fabiola Cartes-Zumelzu, MD, Siegfried Thurnher, MD, Johannes Lammer, MD, Ernst Wolner, MD, and Michael Havel, MD Departments of Cardio-Thoracic Surgery and Interventional Radiology, University of Vienna, Vienna, Austria Background. This study was performed to evaluate the safety and feasibility of endovascular stent graft placement in the treatment of descending thoracic aortic aneurysms. Methods. Between November 1996 and February 1999, endovascular stent graft repair was used in 21 patients. There were 5 women and 16 men with a mean age of 67 years (range, 41 to 87 years). An atherosclerotic aneurysm with a diameter of more than 6 cm was the indication for intervention in 19 patients (90.5%). In 2 patients (9.5%), a localized aortic dissection with a diameter of more than 6 cm was treated. In 71.4% (15 of 21) of patients, multiple stents were necessary for aneurysm exclusion. To allow safe deployment of the stent graft, preliminary subclavian carotid artery transposition was performed in 9 patients (42.9%). Vascular access was achieved through a small incision in the abdominal aorta (n 6), an iliac artery (n 8), or a femoral artery (n 7). Talent and Prograft stent grafts were used. Results. Successful deployment of the endovascular stent grafts was achieved in all patients. Two patients died postoperatively (mortality rate, 9.5%), 1 of aneurysmal rupture and the other of impaired perfusion of the celiac axis. Repeat stenting was done in 3 patients because of intraoperative leakage. Conclusions. Endovascular stent graft repair is a promising and less invasive alternative to exclude the aneurysm from blood flow. This technique allows treatment of patients who are unsuitable for conventional surgical procedures. An exact definition of inclusion criteria and technical development of stent grafts should contribute to further improvements in clinical results. (Ann Thorac Surg 2000;69:441 5) 2000 by The Society of Thoracic Surgeons Thoracic aortic aneurysms are life threatening and continue to challenge surgeons. Surgical repair with a prosthetic vascular graft is the traditional therapy for patients with thoracic aortic aneurysms. Although there have been remarkable improvements in treatment as a result of technical advances and improved prosthetic grafts, the operative mortality remains high [1 3]. The conventional operation is still associated with substantial morbidity, chiefly related to major thoracotomy, use of cardiopulmonary bypass, and postoperative complications including bleeding, paraplegia, stroke, renal insufficiency, and need of prolonged ventilatory support [4]. The success of the first use of endovascular stent graft placement in an abdominal aortic aneurysm [5] prompted investigation into the feasibility of thoracic aortic aneurysm repair with transluminally placed endovascular stent grafts [6, 7]. Initial clinical experiences confirm the feasibility of this new method and show promising results [8 10]. This study was performed to report our initial clinical results and to verify the role of self-expandable stent grafts in the treatment of thoracic Accepted for publication July 7, Address reprint requests to Dr Grabenwöger, Department of Cardio- Thoracic Surgery, University of Vienna, Waehringer Guertel 18-20, Vienna 1090, Austria; martin.grabenwöger@univie.ac.at. aortic aneurysms, to define inclusion and exclusion criteria, and to discuss the postoperative complications. Material and Methods Patient Population Between November 1996 and February 1999, 21 patients underwent endovascular stent graft repair of the descending thoracic aorta at the University of Vienna Medical Center. There were 5 women and 16 men with an average age of 67 years (range, 41 to 87 years). The aneurysm was localized in the proximal part of the thoracic aorta in 6 patients, in the middle part in 3, and in the distal part in 7. Five patients had aneurysmal ectasia of the entire descending thoracic aorta. The maximal aneurysmal diameter ranged from 60 to 90 mm (mean diameter, 68.5 mm). Spiral computed tomographic scanning and angiography of the entire aorta were performed in each patient before the scheduled procedure. Angiocardiography not routinely carried out before stenting, showed occlusion of greater than 50% in the left anterior descending coronary artery and the right coronary artery This article has been selected for the open discussion forum on the STS Web site: by The Society of Thoracic Surgeons /00/$20.00 Published by Elsevier Science Inc PII S (99)

2 442 GRABENWÖGER ET AL Ann Thorac Surg STENTING OF THORACIC AORTIC ANEURYSMS 2000;69:441 5 Fig 1. Talent stent graft system. (World Medical Corp, Sunrise, FL) in 3 of 5 patients. Before the stenting procedure, subclavian carotid artery transposition was necessary in 8 patients to allow safe placement of the stent graft. Hypertension was the most common preoperative medical disorder (85.7%) followed by pulmonary dysfunction (62%) and coronary artery disease (38.1%). As a result of these comorbid conditions, 15 patients (71.4%) were unsuitable candidates for conventional surgical treatment. Four patients had heart disease with an ejection fraction of less than Obstructive pulmonary dysfunction with a forced expiratory volume in 1 second of less than 50% of predicted values was present in 6 patients. A combination of impaired pulmonary function, coronary artery disease, and severe general atherosclerosis was found in 5 patients. Five patients (23.8%) had had a previous cardiac intervention, 3 had had an operation for aneurysm, and 2 had undergone previous coronary artery bypass grafting. An atherosclerotic aneurysm of more than 6 cm in diameter was the indication for intervention in 19 (90.5%) of the 21 patients. In the other 2 patients (9.5%), stent grafting was indicated because of a chronic aortic dissection. In 1 patient, the dissection was limited to the thoracic aorta, and in the other, the false lumen was completely thrombosed. Stent Graft Systems Two different stent graft systems are available to our department. The Talent endoluminal stent graft system (World Medical Corp, Sunrise, FL) was used in 16 patients (Fig 1). Exclusion of thoracic aortic aneurysms with the Prograft stent graft system (W. L. Gore & Associates, Flagstaff, AZ) was performed in 5 patients (Fig 2). The Talent stent graft system consists of a polyurethane placement catheter with one lumen used to carry a guidewire. The catheter also has a central balloon, which molds the spring stent graft to the inside wall of the aorta after deployment. The stent graft itself is made of a polyester vascular graft (Dacron) and a wire stent, that is arranged in a zigzag formation. This self-expandable stent graft is compressed over the placement catheter. Both the spring stent graft and the catheter are loaded into a sheath. The hollow sheath prevents stent graft deployment and makes it possible to introduce the entire stent graft system into the vasculature. The endoluminal stent graft system is passed over the guidewire and positioned at the desired location as determined by intraoperative angiography. After exact positioning, the Fig 2. Prograft stent graft system. (W.L. Gore & Associates, Flagstaff, AZ) sheath is moved downward, and stent graft deployment is achieved. Talent stent grafts are manufactured individually for each patient. Prograft stents are constructed differently. The system is placed into the vasculature through an introduction sheath. The stent graft itself is mounted on a placement catheter. Deployment of the stent graft is achieved by pulling on a string at the end of the placement catheter. Prograft stent grafts are available in standard sizes. Surgical Procedure Thirteen patients (62%) had operation under general anesthesia, and 8 (38%) received only spinal anesthesia. Cardiopulmonary bypass was on standby during every stent procedure. Through a percutaneous left brachial artery approach, a pigtail catheter is inserted over a guidewire, which is used for the intraoperative aortogram. The femoral artery is exposed. If the femoral artery is considered too small in diameter, the iliac artery or the abdominal aorta is used for vascular access. The femoral artery was used for introduction of the stent graft system in 7 patients, the iliac artery in 8 patients, and the abdominal aorta in 6 patients.

3 Ann Thorac Surg GRABENWÖGER ET AL 2000;69:441 5 STENTING OF THORACIC AORTIC ANEURYSMS 443 Fig 4. Roentgenogram of multiple stent grafts deployed in thoracic aorta. Fig 3. Three-dimensional reconstructed spiral computed tomogram of deployed stent graft in proximal aorta. Note subclavian carotid artery transposition, done before stent graft placement. A guidewire is inserted through a transverse arteriotomy and passed above the aneurysm site. After the proximal and distal necks of the aneurysm have been marked, the stent graft system is passed over a guidewire and positioned at the desired location. Exact placement of the stent graft system is determined by angiography. With the placement catheter held stationary, the sheath is removed to deploy the stent graft. The spring stent graft expands and conforms to the size of the normal aorta. The balloon is blown up to maintain sufficient pressure against the aortic wall. Finally, an arteriogram is made to verify complete elimination of the aneurysm and to show free perfusion of the stent graft (Fig 3). The placement system is removed, and the arteriotomy is closed in the usual manner. The length of the thoracic aortic aneurysm often exceeds the maximum length of the individual stent graft. In this situation, it is possible to insert several stent grafts one after the other (Fig 4). To prevent blood from entering the aneurysmal sac, the overlapped stent graft segments have to be expanded with the balloon. For aneurysm exclusion several stents were necessary in 15 patients (71.4%), and in 6 patients (28.6%), a single stent was sufficient. In all patients, spiral computed tomography documented aneurysm exclusion before they were taken to the intensive care unit. Results Successful deployment of the stent grafts in the intended position was accomplished in all 21 patients. For aneurysm exclusion, one to six stents per patient were necessary (mean number, 2.6 stents). The mean length of the stents was mm (range, 100 to 150 mm), and the mean stent graft diameter was 36.8 mm (range, 28 to 44 mm). A sufficient length of normal aorta is necessary to allow safe stent graft deployment. In 9 patients (42.9%), subclavian carotid artery transposition was necessary to establish this length. Intraoperative complications involving leakage into the aneurysmal sac occurred in 3 patients. Two patients had such leakage between two stents, and both patients underwent repeat stenting during the same procedure. The other patient required a second operation, and a separate stent graft was needed to cover the leak. In 1 patient, introduction of the stent graft system caused a dissection of the iliac artery, and iliac femoral bypass was performed. The intraoperative mortality rate was 0%. Two patients (9.5%) died postoperatively, 1 on day 2 and 1 on day 3. One of them had a rupture of the descending thoracic aorta caused by stent penetration through the aortic wall, and the other died of multiple-organ failure, which was caused by ischemia of the celiac axis. One patient required prolonged ventilatory support because of respiratory failure in the postoperative period. A tracheotomy was performed to wean the patient from the respirator. There were no neurologic complications associated with endovascular stent graft placement. None of the 19 survivors have had any serious complications such as aneurysmal enlargement or a change in the position and configuration of the stent graft. The mean stay in the intensive care unit was 5.7 days (range, 1 to 31 days), and the mean hospital stay was 9.8 days (range, 5 to 18 days).

4 444 GRABENWÖGER ET AL Ann Thorac Surg STENTING OF THORACIC AORTIC ANEURYSMS 2000;69:441 5 Comment Successful treatment of thoracic aneurysms can be achieved with the implantation of self-expandable stent grafts. This new method offers the possibility to treat patients who are not candidates for conventional surgical procedures because the technique is less invasive and can be performed with spinal anesthesia. Parodi and coworkers [5] first described the use of endovascular stent grafts to treat aortic aneurysms in Initially, stent graft deployment was performed with the aid of balloon dilatation. Since then, progress has been made, and Mitchell and colleagues [7] substantiated the safety and effectiveness of stent grafts in the repair of thoracic aneurysms. Our initial results with stent graft placement in the descending aorta demonstrate the feasibility of this method. If a patient is considered a candidate for stent graft placement, three major factors have to be taken into account. The most important is location and morphology of the aneurysm; the second is distal vascular access of sufficient size; and the third is limited tortuosity of the abdominal and thoracic aorta. In our patients, preoperative spiral computed tomographic scans and angiograms were made to evaluate the transverse and longitudinal diameters of the aneurysms and their relation to the left subclavian artery and the celiac axis. Determination of the proximal and distal landing zones of the stent graft is essential, as they serve as a friction anchor at each end. A minimum of 1.5 to 2 cm of normal aorta is required for safe stent graft deployment. The grafts were oversized in diameter by 3 to 4 mm to allow sufficient radial force for fixation. In the case of a short proximal neck, subclavian carotid artery transposition must precede stenting to create a safe proximal landing zone. This operation was necessary in 9 (42.9%) of our 21 patients. Besides the morphology of the aneurysm, a suitable vascular access has to be available for introduction of the stent graft system. Contraindications are severe stenosis or occlusion of the abdominal aorta (Leriche s syndrome) and severe tortuosity of the aorta. Substantial kinking of the iliac arteries could be associated with the risk of arterial dissection. We observed this complication in 1 patient in whom manipulation with the stent graft device resulted in dissection of the iliac artery. Because of the diameter of the stent graft devices (24F to 27F), the femoral artery was considered too small for stent introduction in 14 patients. Therefore, vascular access was achieved through the iliac artery or the abdominal aorta. Atherosclerotic aneurysm with a diameter of more than 6 cm was the most frequent indication for intervention (19 of 21 patients). In 2 patients, there was a chronic aortic dissection with a diameter greater than 6 cm. However, we emphasize that in 1 patient, the aortic dissection was limited to the thoracic aorta and in the other, the false lumen was thrombosed. At this time, a chronic dissection type B that elongates into the abdominal aorta represents a contraindication to stent graft placement in our institution. Deployment of the stent Fig 5. Macroscopic aspect of perforated aneurysmal sac after migration of stent graft. graft would entail an occlusion of the entry to the dissection, which results in exclusion of the false lumen followed by malperfusion of the abdominal organs, that are supplied with blood from the false lumen. However, stenting of an acute dissection type B with obliteration of the primary tear could be an interesting and promising approach and should be evaluated in the future. In our series, the hospital mortality rate was 9.5% (2 of 21), which is comparable to the results obtained by others [8 10]. One patient died of perforation of the aneurysm 2 days after uneventful stenting. Perforation was caused by migration of the stent into the aneurysmal sac (Fig 5). We suggested that stent migration be attributed to the severe tortuosity of the thoracic aorta, which caused oblique positioning of the stent graft. The other patient died on the third postoperative day of multiple-organ failure. As angiographic control showed no occlusion but narrowing of the celiac axis by the stent device, ischemia of the abdominal organs is the suspected cause of this fatal complication. Inexact stent deployment in association with a short distal neck caused narrowing of the celiac axis. No neurologic complications were observed in our patients. We noted no incidence of paraplegia, although the distal thoracic aorta was stented in 7 patients, and there is no opportunity to reimplant intercostal branches with this technique. There are two possible explanations for these observations. First, in the case of atherosclerotic aneurysms, many intercostal branches are already occluded, and the spinal cord is supplied by collaterals. Second, the sudden deployment of the stent followed by the occlusion of the intercostal branches does not produce a steal phenomenon in the perfusion of the spinal cord. In the initial series, 71.4% of patients were not candidates for conventional surgical procedures. Because stent graft deployment can be performed with spinal anesthesia, this method offers the possibility to treat these patients. Besides patient selection, the stent graft system itself has to be improved. Accurate stent placement is the most important goal and is not always achievable at this time. Moreover, miniaturization of the stent delivery systems would allow the introduction of most of the stent grafts through the femoral artery, an operation that can be done with spinal anesthesia.

5 Ann Thorac Surg GRABENWÖGER ET AL 2000;69:441 5 STENTING OF THORACIC AORTIC ANEURYSMS 445 In summary, our results demonstrate that exclusion of thoracic aortic aneurysms with self-expandable endoluminal stent grafts represents a promising new method. Technical development of the stent grafts and exact definition of inclusion and exclusion criteria should contribute to further improvements in clinical results. Further studies need to be done to examine the long-term effectiveness of this method, which is performed by cardiac surgeons and interventional radiologists in collaboration. References 1. Ergin AM, Galla JD, Lansman SL, Bodian C, Griepp RB. Hypothermic circulatory arrest in operations on the thoracic aorta. Determinants of operative mortality and neurologic outcome. J Thorac Cardiovasc Surg 1994;107: Grabenwöger M, Ehrlich M, Cartes-Zumelzu F, et al. Surgical treatment of aortic arch aneurysms in profound hypothermia and circulatory arrest. Ann Thorac Surg 1997;64: Fann JI, Dake MD, Semba CP, Liddell RP, Pfeffer TA, Miller DC. Endovascular stent-grafting after arch aneurysm repair using the elephant trunk. Ann Thorac Surg 1995;60: Deeb MG, Jenkins E, Bolling SF, et al. Retrograde cerebral perfusion during hypothermic circulatory arrest reduces neurologic morbidity. J Thorac Cardiovasc Surg 1995;109: 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;33: Mitchell RS, Dake MD, Semba CP, et al. Endovascular stent-graft repair of thoracic aortic aneurysms. J Thorac Cardiovasc Surg 1996;111: Kato M, Ohnishi K, Kaneko M, et al. New graft-implanting method for thoracic aortic aneurysm or dissection with a stented graft. Circulation 1996;94(9 Suppl 2): Parodi JC. Endovascular stent graft repair of aortic aneurysms. Curr Opin Cardiol 1997;12: Ehrlich M, Grabenwoeger M, Cartes-Zumelzu F, et al. Endovascular stent graft repair for aneurysms on the descending thoracic aorta. Ann Thorac Surg 1998;66: Notice From the American Board of Thoracic Surgery The part I (written) examination will be held at the Hotel Sofiel, 5500 North River Rd, Rosemont, IL , on November 19, The closing date for registration is August 1, Those wishing to be considered for examination must request an application because it is not automatically sent. To be admissible to the part II (oral) examination, a candidate must have successfully completed the part I (written) examination. A candidate applying for admission to the certifying examination must fulfill all the requirements of the Board in force at the time the application is received. Please address all communications to the American Board of Thoracic Surgery, One Rotary Center, Suite 803, Evanston, IL 60201; telephone: (847) ; fax: (847) ; abts_evanston@msn.com by The Society of Thoracic Surgeons Ann Thorac Surg 2000;69: /00/$20.00 Published by Elsevier Science Inc

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