The Dirty Truth About Resuscitative Endovascular Balloon Occlusion of the Aorta: A Descriptive Analysis of Infection Rates in a High-Risk Population

Abstract

Introduction:

Resuscitative endovascular balloon occlusion of the aorta (REBOA) has become a viable alternative to open aortic occlusion for hemorrhage control. It is often performed without maximal barrier precautions, and sterility is not consistently ensured. As REBOA usage increases, a knowledge gap exists in its infectious risks. We sought to characterize the type and incidence of infectious complications in patients undergoing REBOA.

Patients and Methods:

A retrospective review of all REBOA patients at an urban, American College of Surgeons-verified Level I Trauma Center was conducted from November 2016 to September 2023. The trauma registry was queried for all patients who underwent REBOA placement. Data pertaining to patient demographics and infectious complications were obtained for descriptive analysis. The medical record was then examined for the source of bacteremia and other infectious complications. Patients who did not survive beyond hospital day two were excluded.

Results:

Seventy patients met the inclusion criteria. The median age was 40.3 years (IQR 29.5), and patients were predominantly male (72.8%). The overall mortality rate was 19.1%. Among all patients, 37% (n = 26) developed pneumonia, 17% (n = 12) had a deep or organ-space surgical site infection (SSI), and 12.8% (n = 9) had a blood stream infection. None were bacteremic within 48 hours of REBOA placement. All blood stream infections could be associated with concurrent infections such as intra-abdominal sepsis, pneumonia, or soft tissue infection. No SSIs were identified at the site of vascular access.

Conclusions:

Our findings demonstrate a modest rate of infectious complications among patients undergoing REBOA placement, comparable with published historical data, but no evidence to suggest infectious complications directly related to REBOA placement. Although limited by small sample size and single-institution experience, this study serves as one of the first studies to describe the infection rates in patients undergoing REBOA. Further prospective multi-center studies are required to evaluate the true infectious risks associated with REBOA.

Keywords

bacteremia REBOA Trauma

Resuscitative endovascular balloon occlusion of the aorta (REBOA) was initially pioneered in a combat setting during the 1950s in the Korean War.¹ This technique emerged as a potential temporizing intervention in cases of severe hemorrhage.^1–3 The use of REBOA to provide complete, or now partial, aortic occlusion has become a viable alternative to open aortic occlusion for hemorrhage control.⁴ Partial aortic occlusion is now being used as an adjunct to resuscitation that can provide prolonged occlusion times and lead to decreased resuscitation requirements.^5,6

The collaboration between the American College of Surgeons (ACS) Committee on Trauma and the American College of Emergency Physicians has led to the development of a comprehensive guideline for REBOA. This guideline outlines patient indications, implementation, patient management, potential complications, and physician training.^7,8 Despite the rigorous standards set forth in this guideline, no medical procedure is devoid of risk, and REBOA is no exception. Commonly described complications associated with REBOA include reperfusion injuries of the distal organs, arterial injuries along the catheter pathway, and acute kidney failure, but there is minimal information on infection complications in REBOA.^9–11

The frequent utilization of REBOA in emergent situations poses specific challenges. It can be hard to balance the speed needed to ensure temporary stabilization with successfully maintaining sterility and mitigating infection risks. Given the existing gap in the literature regarding the infectious risks associated with REBOA, our study aims to investigate the incidence and nature of infectious complications among patients managed with REBOA.

Patients and Methods

A retrospective cohort review, approved by our institutional review board, was performed of the trauma registry at our ACS-verified Level I Trauma Center between November 28, 2016, and September 30, 2023. This time period was selected as it coincided with the initiation of the REBOA program at our institution. Patients requiring REBOA placement during this time who survived more than two hospital days were included. The institutional trauma registry was then queried for data pertaining to patient demographics, mechanism of injury, indications and timing of REBOA placement, clinical course, infectious complications, and mortality. Infectious complications were defined as blood stream infection, pneumonia, and surgical site infections (SSIs). In patients who had bacteremia, the electronic medical record was scoured to determine the source. A descriptive analysis to investigate patterns of infectious complications in REBOA patients was then conducted.

Our institutional guidelines for REBOA use include patients with persistent systolic blood pressure below 90, transient response to blood product resuscitation, or transfusion of more than two units of blood given. REBOA catheters are placed by attending trauma surgeons or fellows. There is no mandate on sterile barrier precautions given the emergent nature of the procedure for patients in extremis. Sterile dressings are encouraged; however, this is not routinely adhered to for the same reason. Our institutional practice is that the REBOA catheter and sheath are removed once definitive hemorrhage control is obtained in either the operating room or interventional radiology, ensuring REBOA catheters and sheaths remain in place for as little time as possible.

For this study, bacteremia, pneumonia, and SSI were defined as follows: Bacteremia as any positive, non-contaminated, blood cultures after REBOA placement. Pneumonia is a clinically substantial pulmonary infection, with or without positive respiratory cultures. SSIs are defined by the National Healthcare Safety Network. A superficial SSI is any infection involving only skin and subcutaneous tissue of the incision, and a deep SSI is any infection involving deep soft tissues of the incision. An organ-space SSI is any infection involving any part of the body deeper than the fascial/muscle layers that is opened or manipulated during the operative procedure.

Results

Patient demographics

During our study period, 105 patients underwent REBOA placement. Of those, 70 survived more than two days and were included for analysis. These patients were predominantly male (73%), with an average age of 40 years with an IQR of 29.5. The majority of these patients suffered blunt trauma (87%) and were severely injured with a mean injury severity score (ISS) of 39.8. The mean length of stay was 35.3 days, and the survival rate for the 70 patients included was 81.4%. Full patient demographics are listed in Table 1. All REBOA catheters were placed percutaneously with no cutdowns performed. Antibiotic agents were not required, but 64 (91%) patients received antibiotic agents in the ED, upon arrival to the operating room, or in interventional radiology.

Table 1.

Patient Demographics and Infectious Morbidity

Age (years)	40.3 y
% Male	72.8%
% Blunt	87.2%
Injury severity score (mean ± SD)	39.8
Length of stay (days)	35.3 d
Survival rate of patients surviving 48 h	81.4%
Superficial surgical site infection (SSI)	0
Deep organ-space SSI	12 (17.1%)
Pneumonia	26 (37.1%)
Bacteremia	8 (11.4%)
Fungemia	1 (1.4%)

SD = standard deviation.

Blood stream infections

The overall rate of blood stream infections in this cohort was 12.8%. Eight patients suffered bacteremia (11.4%) during their admission, and one patient (1.4%) was found to be fungemic. Table 2 lists the bacterial species identified and the presumed source based on concurrent infections at the time of positive cultures. The timing to positive cultures was hospital day seven or greater in 75% of identified patients, with the median time to bacteremia being 9.5 days. The majority (seven of eight) of patients with bacteremia were blunt polytrauma patients. Patients with positive blood cultures had a prolonged length of stay at 45 days. Of patients found to be bacteremic during their hospital course, seven (88%) received antibiotic agents in the ED, upon arrival to the operating room, or in interventional radiology. Ancef was most frequently administered. Rocephin, cefoxitin, and vancomycin were also used. All blood stream infections had an association with a non-REBOA source.

Table 2.

Blood Stream Infections and Presumed Source

Patient	Pathogen	Presumed source	Discharge status
1	MSSA	Pneumonia	Alive
2	Pseudomonas aeruginosa	Pneumonia	Alive
3	Escherichia coli	Urinary tract	Hospice
4	Enterococcus faecalis	Abdominal	Alive
5	E. coli	Abdominal	Deceased
6	Enterobacter aerogenes	Pneumonia	Alive
7	Bacteroides fragilis	Abdominal	Alive
8	E. aerogenes	Pneumonia	Alive
9	Candida auris	Empyema/pneumonia	Hospice

Pneumonia

Twenty-six patients (37.1%) developed pneumonia during their hospitalization. Twenty-one (30%) of these were ventilator-associated pneumonia (VAP). One patient was found to have COVID pneumonia. No unusual or unexpected causative organisms were identified as causative organisms.

Surgical site infections

Twelve patients were found to have deep or organ-space SSIs. These included two empyemas, seven intra-abdominal infections, and three infections within the extremity musculature. No deep or organ-space infections were attributable to REBOA placement. In addition, there were no SSIs at REBOA placement sites in the groin.

Discussion

This single-institution, retrospective analysis of traumatic patients demonstrated a modest rate of infectious complications comparable with similarly injured trauma patients. All patients who developed infectious complications in the setting of REBOA placement had a clearly discernible source unrelated to the catheter’s presence. Our findings are consistent with historical rates and do not suggest increased infectious complications related directly to REBOA placement.

Increased ISS has consistently been associated with an increased risk of infectious complications.^12,13 Fakhry et al. identified that patients with bacteremia were more likely to be male, suffer blunt trauma, have prolonged hospital stays, and require intensive care unit (ICU) level of care.¹² Those qualities fit the demographics of our patient population and further illustrate the risk patients who undergo REBOA have for infectious complications regardless of catheter placement. Our single-institution, retrospective analysis of trauma patients undergoing REBOA demonstrated a modest rate of infectious complications; however, the rates are comparable with these historic precedents.

Smith et al. showed that 71% of all central line-associated blood stream infections at major urban trauma centers were associated with breaks in sterile technique.¹⁴ Although arterial cannulation has a lower risk of infection than venous cannulation, the U.S. Centers for Disease Control and Prevention still recommends sterile techniques for both venous and arterial line placement.¹⁵ Arterial lines placed under sterile conditions have been found to have a blood stream infection rate of 1.3%.¹⁶ Unfortunately, REBOA is often placed emergently in the critically ill trauma patient, without the luxury of sterile preparation or maximal precautions. In our study, 11.4% of patients were found to be bacteremic, and 1.4% of patients were fungemic during their hospital course. Although the overall rate of bacteremia in trauma patients is less than 1%, it is substantially increased in critically ill polytrauma patients in the ICU.¹² In studies conducted by Lee et al. and El-Masri et al., the authors found that the rates of bacteremia in critically ill trauma patients were as high as 4%–15% in more recent series.^17–18 When investigating REBOA in traumatic brain injury patients, Brenner et al. found a similar rate of bacteremia at 12.8% in patients who survived beyond the operating room.¹⁹ In our series, all blood stream infections could be linked to a concurrent infection such as intra-abdominal sepsis, pneumonia, or soft tissue infection. This connection was determined by temporal association with concomitant infections and the causative pathogen. Although we are not able to generalize this because of the limitations of this study, it is promising that our blood stream infection rates are similar to previous studies in which similar trauma patients did not undergo REBOA. Further prospective research may help elucidate the true rates of infection between similar groups.

Similar to blood stream infections, pneumonia and SSIs were comparable with published historical data and had plausible alternative sources other than REBOA placement. The overall VAP rate in trauma patients ranges between 11% and 17%; however, it includes all comers.^20–21 The VAP rate of critically ill trauma patients is much higher at 30%–31% and closer to our observed VAP rate of 30%.^20,22 The rate of pneumonia in our study was 37% and may be, in part, attributable to the prolonged ventilator days, with a median 32 days.^20,23–24 Fifteen percent of patients undergoing trauma laparotomy have been shown to have organ-space SSI, comparable with the 17% seen in this study.²⁵

The similar infection rates in this critically ill trauma population may be multi-factorial. Our institution’s guideline emphasizes a rapid removal of the sheath and catheter once the patient has stabilized, thus minimizing REBOA dwell time. In addition, there are some preliminary data that more advanced REBOA catheters can limit the amount of blood transfused, which is a well-documented risk factor for infection.⁶ Finally, although standard barrier precautions are advocated by the CDC and other organizations, these have yet to demonstrate a decrease in risk of arterial line colonization or infection.²⁶

This study has multiple limitations. First, it is a single-institution retrospective study. There is variability among institutional and practitioner REBOA protocols, and infectious rates from this institution’s protocol may not be generalizable to all. Furthermore, the degree of sterility varied between providers, patients, and available equipment. Finally, our study is purely descriptive, and we use historic data to compare our results. A true prospective controlled study is required to determine the true rates of infection between similar critically ill trauma patients who do and do not receive REBOA.

Conclusion

In this descriptive analysis of a single-institution experience of trauma patients who underwent REBOA, we found a modest rate of infectious complications, comparable with published historical data on similarly injured trauma patients. To our knowledge, this is the largest study describing the rates of infections in REBOA patients and adds to the limited literature on REBOA complications. Overall, the severely injured patient who typically undergoes REBOA placement is at a high risk for infection during the hospital course. Our infectious rates in patients receiving REBOA were similar to rates seen in other studies where patients did not receive REBOA. Further prospective multi-center studies are required to evaluate the true infectious risks associated with REBOA.

Authors’ Contributions

J.W.: Conceptualization (supporting), writing—original draft (lead), formal analysis (lead), and writing—review and editing (equal). C.M.: Writing—review and editing (equal). V.W.: Review and editing (equal). V.A.: Review and editing (equal). E.A.: Writing—original draft (supporting). R.F.: Supervision (supporting). C.C.: Supervision (supporting). S.R.T.: Review and editing (equal) and supervision (supporting). R.N.S.: Review and editing (equal) and supervision (supporting). J.D.S.: Review and editing (equal) and supervision (supporting). J.N.: Conceptualization (lead), writing—original draft (supporting), formal analysis (supporting), writing—review and editing (supporting), and supervision (lead).

Footnotes

Acknowledgments

The authors thank their colleagues from Grady Hospital, Emory University, and Morehouse School of Medicine for support of this research. They also would like to show their gratitude to the Grady Research Coordinators for sharing their pearls of wisdom with the authors during this research and maintaining their REBOA registry. The authors also thank the two reviewers for their well-thought-out commentary.

Author Disclosure Statement

J.N. receives honoraria from Prytime Medical, Zimmer-Biomet, and Teleflex for educational lectures. J.N. and the trauma center participate in the DoD Grant-funded (W81xwh-22-90015) study for Partial REBOA Outcomes Multi-Center Prospective (PROMPT). The trauma center is participating in the pREBOA-PRO Centers of Excellence. The authors have no additional conflicts of interest to report.

Funding Information

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

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