Protocol - Western Trauma Association

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Contemporary Management of Subclavian and Axillary Artery Injuries
Background
Subclavian and axillary arterial injuries, whether blunt or penetrating, are relatively
uncommon and there have been few recent reviews in the literature. Traditional open exposure
with direct vascular repair has been the mainstay of therapy through utilization of a single or
combination of different incisional exposures: median sternotomy, supraclavicular and
infraclavicular.1,2 Control of hemorrhage can be challenging due to rigid chest wall structures
and disruption of normal anatomic planes by hematomas and direct soft tissue injury.1,3 Due to
the nature of these vascular injuries and complex anatomy, mortality rates have been reported as
high as thirty percent.1,3-5 With limited exposure and anatomic challenges, there is a current
trend to consider other surgical options for repair of subclavian and axillary artery injuries. With
the development of endovascular techniques, more institutions are reporting complete
endovascular repair or a hybrid approach to the repair of subclavian and axillary artery injuries.6
Most previous studies have included a small number of cases with little literature on the use of
endovascular technology in the management of these arterial injuries.4,6-9 Some institutions
continue to support only open repairs while others utilize endovascular methods for proximal
control of bleeding in a hybrid approach to augment complex open procedures. Others report
complete endovascular repairs using balloons for proximal control and endoluminal stents for
definitive repair.6 The outcomes of endovascular repairs and comparative results with open
techniques remain unknown and ripe for evaluation. We aim to study the recent evolution of
subclavian and axillary artery injury repairs and outcomes encompassing mid-term (thirty days to
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one year) and long-term (greater than one year) results in a 10-15 year multi-center retrospective
manner.
Hypotheses
1. Management of subclavian and axillary artery injuries have changed with the
introduction of endovascular techniques.
2. Mid-term and long-term results (30 days to one year and greater than one year,
respectively) for endovascular repair are comparable to open approach repairs.
3. Mortality and morbidity are decreased with endovascular repair.
4. Current American Association for the Surgery of Trauma Organ Injury Scale does not
accurately correlate with outcomes of subclavian and axillary artery injuries.
Methods
A retrospective review of the medical records of all patients who presented to Gundersen
Health System with a subclavian or axillary arterial injury (ECODES: Axillary/Brachial artery:
903.01, Subclavian artery: 901.1) from January 1, 2004 through December 31, 2014 will be
completed. In order to obtain and adequate sample size, additional institutions will be invited to
submit data through the Western Trauma Association’s Multicenter Trials Committee. Patients
will be identified through a query of each study sites’ trauma registry and/or electronic medical
record system. Patient identifiers are necessary in order to identify and include all eligible
patient records from Gundersen Health System. Data submitted from participating sites will be
de-identified prior to submission to research personnel at Gundersen Health System. All data
collected will be kept secure in the Gundersen surgery research office, and any identifying
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information will be destroyed upon completion of the study. The data needed for this study is
spread throughout the patients’ charts. Only research personnel will have access to the data. The
research personnel at Gundersen Health System will be responsible for both data collection and
data entry into the computer program for analysis. Approximately 250 medical records will be
reviewed for this study.
Statistical analysis will include descriptive statistics, chi-square test, t tests, univariate
and multivariate regression analyses, and Kaplan Meier survival analysis. A P value < 0.05 will
be considered significant.
Data Collection
Data Collection will include the variables listed in the data collection tool.
Budget
No funding is needed for this study.
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References
1. Cox CS Jr, Allen GS, Fischer RP, et al. Blunt versus penetrating subclavian artery injury:
presentation, injury pattern, and outcome. J Trauma. 1999;46(3):445-9.
2. Katras T, Baltazar U, Rush DS, et al. Subclavian arterial injury associated with blunt
trauma. Vasc Surg. 2001;35(1):43-50.
3. McKinley AG, Carrim AT, Robbs JV. Management of proximal axillary and subclavian
artery injuries. Br J Surg. 2000;87(1):79-85.
4. Hoff SJ, Reilly MK, Merrill WH, Stewart J, Frist WH, Morris JA Jr. Analysis of blunt
and penetrating injury of the innominate and subclavian arteries. Am Surg.
1994;60(2):151-4.
5. Sobnach S, Nicol AJ, Nathire H, Edu S, Kahn D, Navsaria PH. An analysis of 50
surgically managed penetrating subclavian artery injuries. Eur J Vasc Endovasc Surg.
2010;39(2):155-9.
6. Carrick MM, Morrison CA, Pham HQ, et al. Modern management of traumatic
subclavian artery injuries: a single institution's experience in the evolution of
endovascular repair. Am J Surg. 2010;199(1):28-34.
7. Castelli P, Caronno R, Piffaretti G, et al. Endovascular repair of traumatic injuries of the
subclavian and axillary arteries. Injury. 2005;36(6):778-82.
8. Patel AV, Marin ML, Veith FJ, Kerr A, Sanchez LA. Endovascular graft repair of
penetrating subclavian artery injuries. J Endovasc Surg. 1996;3(4):382-8.
9. du Toit DF, Lambrechts AV, Stark H, Warren BL. Long-term results of stent graft
treatment of subclavian artery injuries: management of choice for stable patients? J Vasc
Surg. 2008;47(4):739-43.
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