Covered stents for injuries of subclavian and axillary arteries

Covered stents for injuries of subclavian and axillary arteries Eleftherios S. Xenos, MD, Michael Freeman, MD, Scott Stevens, MD, David Cassada, MD, John Pacanowski, MD, and Mitchell Goldman, MD, Knoxville, Tenn Introduction: Injury to the subclavian and axillary arteries is uncommon. Exposure of these vessels is associated with significant morbidity, and mortality ranges from 5% to 30%. Endovascular methods may offer an alternative approach to these technically challenging injuries. Methods: We retrospectively studied patients with blunt or penetrating (including iatrogenic) injuries to the subclavian or axillary artery between January 1, 1996 and July 30, 2002. Demographic data, mechanism of injury, concomitant injuries, angiographic findings, and treatment method and outcome were recorded. Results: Twenty-seven patients with injury to the subclavian or axillary artery were seen at our institution during the study. Twenty-three patients underwent interventions. Eleven patients required open repair; 12 patients had lesions amenable to endovascular repair. Depending on the preference of the surgeon, 5 patients with injuries amenable to endovascular repair underwent open repair, and 7 underwent endovascular repair. A Wallgraft endoprosthesis was used in all patients; two grafts were required in 1 patient. Endovascular repair was associated with shorter operative time (P ⴝ .04) and less blood loss (P ⴝ .01). One-year patency was similar between the two groups. Conclusion: Covered stents are a feasible alternative to open repair in properly selected patients with subclavian or axillary artery injury, resulting in shorter procedure time and less blood loss. (J Vasc Surg 2003;38:451-4.)

Most subclavian and axillary injuries occur as a result of penetrating trauma. Proximal and distal control of the injured vessel is not always easy, and involves extensive dissection,1 including a combination of supraclavicular or infraclavicular incision, median sternotomy, and thoracotomy. As a result, postoperative morbidity and risk for further injury to surrounding structures is significant. Recently an endovascular approach with covered stents has been used to treat subclavian and axillary artery injuries.2-4 Endovacular techniques offer an alternative by averting direct dissection in the zone of injury. Case reports have indicated successful treatment of subclavian pseudoaneurysm with balloon-expandable and self-expandable stents.2,3 Sullivan et al4 reported use of covered Palmaz stents for endovascular exclusion of axillary and subclavian pseudoaneurysm in 3 patients. Du Toit et al5 used the Hemobahn endovascular prosthesis (W. L. Gore & Associates, Flagstaff, Ariz) in 10 patients with penetrating injuries of the subclavian, carotid, and axillary arteries. This type of therapy is appealing in a patient population that frequently has multiple traumatic injuries or medical comorbid conditions. We report a retrospective review of our experience with open and endovascular repair of subclavian or axillary injuries in which all patients who underwent endovascular From the Department of Surgery, University of Tennessee. Competition of interest: none. Presented at the Twenty-seventh Annual Meeting of the Southern Association for Vascular Surgery, Tucson, Ariz, Jan 15-18, 2003. Reprint requests: Eleftherios S. Xenos, MD, University of Tennessee, Department of Surgery, 1924 Alcoa Hwy, Knoxville, TN 37920-6999 (e-mail: [email protected]). Copyright © 2003 by The Society for Vascular Surgery. 0741-5214/2003/$30.00 ⫹ 0 doi:10.1016/S0741-5214(03)00553-6

repair received a Wallgraft (Boston Scientific, Natick, Mass). MATERIAL AND METHODS Data were reviewed for all patients seen at the University of Tennessee Medical Center in Knoxville (UTMCK) with blunt or penetrating injuries (including iatrogenic) to the subclavian and axillary arteries between January 1, 1996 and July 30, 2002. Demographic data, mechanism of trauma, blood pressure, concomitant injuries at presentation, and treatment method were recorded. Blood loss, operative time, and wound-related complications were noted. Angiograms were examined to identify lesions amenable to endovascular treatment. Clinical evaluation and noninvasive examination with duplex ultrasound scanning were performed to evaluate graft patency after discharge. Length of recovery was not compared, because patients in both groups had multiple related injuries or medical comorbid conditions that primarily determined their length of stay. The Mann-Whitney rank-sum test and Fisher exact test were used for statistical evaluation. P ⬍ .05 was considered significant. Results are given as mean ⫾ SEM. RESULTS Twenty-seven patients with injury to the subclavian or axillary artery were seen between January 1, 1995 and July 30, 2002 (Table I). Two patients died before intervention, 2 patients underwent nonoperative treatment, and 23 patients underwent angiography resulting in either surgical or endovascular repair (EVAR). Eleven patients had extensive, non-focal segment injury of the vessel, transection or occlusion, and this subset underwent open surgical repair. The remaining 12 patients had focal lesions amenable to endovascular therapy or open repair. Of these, five under451

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Table I. Clinical characteristics of study population No. of patients Gender (M/F) Age (y) Average Range Mechanism of injury Penetrating Blunt Iatrogenic Vessel injury Subclavian Axillary

16/11 33.3 19-74 11 13 3 10 17

went open surgical repair and seven underwent endovascular repair, depending on surgeon preference. Mechanism and type of injury, associated injuries and medical conditions, trauma score (for patients with trauma), treatment, and 1-year patency are summarized for the open repair group in Table II and for the endovascular repair group in Table III. The three iatrogenic injuries occurred after subclavian vein catheterization attempts, resulting in arteriovenous fistula between the subclavian artery and vein. A Wallgraft endoprosthesis (Boston Scientific, Natick, Mass) was used for all endovascular repairs. The injury was approached percutaneously through the femoral artery in 4 patients and through brachial artery cutdown in 3 patients. Lesions that appeared difficult to cross were accessed through the brachial artery because this provides a direct, shorter, less tortuous approach. The Seldinger technique was used, with 0.035-inch guide wires and 9F to 10F sheaths. Vessel diameter was not a criterion in selecting patients for open repair or covered stent placement. The size of the stent graft to be implanted was determined with intravascular balloons of known length and diameter. The stent graft was oversized by 10% to 20% to ensure seal. Six procedures were performed with the patient under general anesthesia, and one procedure with intravenous sedation and local anesthesia. All patients who received general anesthetic were intubated before the procedure, because of trauma or primary disease. There were no vascular access site–related complications and no endograft infections in the endovascular repair group. Two patients in the endovascular repair group died of complications of the primary disease, at 3 weeks and 8 months, respectively, after stent placement. There was no clinical evidence of graft occlusion at the time of death. One endoprosthesis became occluded 9 months after placement. Arm claudication developed, and the patient underwent carotid artery to axillary artery bypass grafting. In the open repair group, 1 patient underwent primary repair and 4 patients underwent reverse saphenous vein interposition grafting. All interposition grafts were patent at 1 year. There were no wound infections and no limb loss–related complications in either group. Blood loss was significantly less for patients who underwent endovascular repair (70 ⫾ 12.2 mL vs 220 ⫾ 56.1 mL; P ⫽ .01). Procedure time was shorter with the

endovacular approach compared with open repair (132 ⫾ 15 minutes vs 193 ⫾ 15 minutes; P ⫽ . 04). Patency rate at 1 year was not significantly different between the open and endovascular repair groups (P ⫽ 1; Fisher exact test). DISCUSSION Subclavian and axillary artery injuries constitute 5% to 10% of artery trauma in civilians.6 The most frequent cause is penetrating trauma,7 and structures concomitantly involved include the brachial plexus,8 aerodigestive tract, sympathetic chain, and spinal cord.1 Surgical stress, frequently combined with concomitant injuries, results in significant morbidity.1 Kalakuntla et al9 reported a postoperative complication rate of 24%. Mortality ranges from 5% to 30% in various studies.10-12 Endovascular covered stent placement eliminates the acute need for surgical dissection, decreasing the risk for injuring important adjacent structures such as the vagus nerve, recurrent laryngeal nerve, and phrenic nerve, and the innominate vein. Careful patient selection is necessary, and only focal lesions that can safely be traversed with a guide wire can be approached in this fashion. Patients with decreased life expectancy when longterm patency is not a primary concern might benefit from this less invasive procedure. Also, patients who are poor candidates for general anesthesia can undergo an endovascular approach with intravenous sedation and local anesthesia. In our series, two patients (28%) died of complications of the primary disease, that is, diltiazem overdose 3 weeks after stent placement in 1 patient and complications of human immune deficiency virus infection 8 months after placement in the other patient. A Wallgraft endoprosthesis was used in all of our patients. This was the only covered stent available in our hospital during the study period. The Wallgraft is a selfexpandable braided steel stent covered with a Dacron graft. Covered Palmaz stents and expandable polytetrafluoroethylene (ePTFE)– covered stents also have been used to treat subclavian or axillary artery injuries.4,5 Patency and other outcomes may be different with Dacron- covered stents versus ePTFE-covered stents. Technically, we must consider shortening of the stent that occurs with deployment. One of our patients required two grafts for complete coverage of the injury. Care also must be taken to not occlude the vertebral artery during stent placement. The femoral percutaneous approach was used in 4 patients, and a brachial artery cutdown in 3 patients. The brachial approach provides better control of the guide wire and a more direct route to a lesion in which a large part of the circumference of the vessel may have been disrupted. This may also be done percutaneously. We did not find vessel size to be a decisive factor in our choice of open repair or endovascular repair. Phipp et al13 reported 3 patients in whom stents or stent grafts were placed in the subclavian artery or vein to treat thoracic outlet syndrome, and 6 months to 2 years later had stent fracture. Compression of the endoprosthesis between the clavicle and the first rib is most likely the cause of fracture in this location. The pathophysiology of occlu-

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Table II. Summary of clinical features of patients who underwent open repair Patient 1

Patient 2

Age Gender Mechanism of injury Trauma score BP ⬍ 90 at presentation (uninjured arm) Associated injuries

74 Female Motor vehicle accident 10 No

Vessel injury

Axillary artery, branch bleeding Primary repair

Axillary artery, pseudoaneurysm

Yes

Yes

Repair

One-year patency

34 Male Gunshot wound 12 No

Bypass with reverse saphenous

Patient 3

Patient 4

Patient 5

25 Male Motor vehicle accident 12 No

48 Male Logging accident 6 No

33 Male Gunshot wound

Brachial plexus

Subclavian artery, intimal dissection Bypass with reverse saphenous vein

Rib fractures, pneumothorax Axillary artery, initimal dissection Bypass with reverse saphenous vein Yes

Yes

12 No

Subclavian artery, pseudoaneurysm Bypass with reverse saphenous vein Yes

Table III. Summary of clinical features of patients who underwent endovascular repair Patient 1

Patient 2

Patient 3

Age 19 32 31 Gender Male Female Male Mechanism of Motor vehicle Gunshot wound Gunshot wound injury accident Trauma score 6 12 12 BP ⬍ 90 at Yes No No presentation (uninjured arm) Associated Multiple injuries/ intrabdominal, comorbidities pneumothorax, long bone fractures, brachial plexus Vessel injury Vertebral artery, Subclavian artery, Late (4 mo after avulsion/ pseudoinjury) bleeding aneurysm subclavian artery, pseudoaneurysm Repair 9 mm Wallgraft 8 mm Wallgraft 10 mm Wallgraft Access site One-year patency

Femoral Yes

Brachial Yes

Brachial Yes

Patient 4 30 Male Stab wound 7 No

Patient 5 37 Female Iatrogenic No

Patient 6 44 Female Iatrogenic No

Patient 7 39 Female Iatrogenic No

Hemothrox, Pneumothorax Self-induced HIV, renal failure, pneumothorax diltiazem malnutrition, overdose, chronic, ARDS, anemia, renal pulmonary failure edema, candidemia Axillary artery, AVF AVF AVF pseudoaneurysm 9 mm Wallgraft 8 mm Wallgraft Femoral Femoral Yes No; occluded 9 mo after placement

Two 7 mm 7 mm Wallgraft Wallgrafts Brachial Femoral NA; patient NA; patient died died 3 wk 8 mo after stent after stent placement placement

ARDS, adult respiratory distress syndrome; HIV, human immunodeficiency virus; AVF, arteriovenous fistula; NA, not available.

sive disease or thoracic outlet syndrome is different from the pathophysiology of traumatic injuries. We have not encountered problems with stent fracture in our patients. Short-term results of endovascular repair, as reported by Patel et al14 and du Toit et al5 are encouraging, but long-term durability has not been established. Nevertheless, stent thrombosis does not preclude future revascular-

ization, which, if necessary, is done under less emergent circumstances after the acute injury has resolved. Subclavian and axillary vessel injuries occur infrequently, and it is unlikely that a prospective randomized trial with a sufficient number of patients will be conducted comparing the endovascular and open approaches. A potential bias was introduced in our study, because selection

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of open repair or endovascular repair was determined by surgeon preference. The purpose of our report is not to indicate superiority of either of these methods. Rather, we believe that, in properly selected patients, covered stents offer an additional way of dealing with these injuries. A limitation of our study is the relatively small number of patients, although the largest retrospective series to date reported 79 patients,11 and most series include 21 to 28 patients.1,7,9 In conclusion, endovascular techniques are an alternative approach to treatment of subclavian or axillary injury, and result in shorter operative time and less blood loss. Short-term patency is similar to that with the open approach. Nevertheless, this is a new technique, and longterm results are under evaluation. Therefore periodic patient follow-up and graft assessment are necessary. REFERENCES 1. Abouljoud MS, Obeid FN, Horst HM, Sorensen VJ, Fath JJ, Ghung SK. Arterial injuries of the thoracic outlet: a ten-year experience. Am Surg 1993;59:590-5. 2. Hernandez JA, Pershad A, Laufer N. Subclavian artery pseudoaneurysm: successful exclusion with a covered self-expanding stent. J Invas Cardiol 2002;14:278-9. 3. Pastores SM, Marin ML, Veith FJ, Bakal CW, Kvetan V. Endovascular stented graft repair of a pseudoaneurysm of the subclavian artery caused by a percutaneous internal jugular vein cannulation: case report. Am J Crit Care 1995;4:472-5.

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4. Sullivan MT, Bacharach MJ, Perl MD, Gray B. Endovascular management of unusual aneurysms of the axillary and subclavian arteries. J Endovasc Surg 1996;3:389-95. 5. Du Toit DF, Strauss DC, Blaszzyk M, de Villers R, Warren BL. Endovascular treatment of penetrating thoracic outlet arterial injuries. Eur J Vasc Endovasc Surg 2000;19:489-95. 6. Hyre CE, Cikrit DF, Lalka SG, Sawchuk AP, Dalsing MC. Aggressive management of vascular injuries of the thoracic outlet. J Vasc Surg 1998;27:880-5. 7. Hoff SJ, Reilly MK, Merrill WH, Stewart J, Frist WH, Morris JM. Analysis of blunt and penetrating injury of the innominate and subclavian arteries. Am Surg 1994;60:151-4. 8. Johnson SF, Johnson SB, Strodel WE. Brachial plexus injury: association with subclavian and axillary trauma. J Trauma 1991;31:1546-50. 9. Kalakuntla V, Vijaykumar P, Tagoe A, Weaver W. Six-year experience with management of subclavian artery injuries. Am Surg 2000;65:92731. 10. Rich NM, Hobson RW, Jarstfer BS. Subclavian artery trauma. J Trauma 1973;13:485-96. 11. Demetriades D, Chahwan S, Gomez H, Peng R, Velmahos G, Murray J, et al. Penetrating injuries to the subclavian and axillary vessels. J Am Coll Surg 1999;188:290-5. 12. George SM, Croce MA, Fabian TC. Cervicothoracic arterial injuries: recommendation for diagnosis and management. World J Surg 1991; 15:134-40. 13. Phipp LH, Scott JA, Kessel D, Robertson I. Subclavian stents and stent-grafts: cause for concern? J Endovasc Surg 1999;6:223-6. 14. Patel AV, Veith FJ, Kerr A, Sanchez LA. Endovascular graft repair of penetrating subclavian artery injuries. J Endovasc Surg 1996;3:382-8. Submitted Feb 17, 2003; accepted Mar 31, 2003.