TY - JOUR
AU - Krzyzaniak, Michael
AB - Abstract Introduction Non-compressible torso hemorrhage accounts for 70% of battlefield deaths. Resuscitative endovascular balloon occlusion of the aorta (REBOA) is an emerging technology used to mitigate massive truncal hemorrhage. Use of REBOA on the battlefield is limited by the need for radiographic guided balloon placement. Radiofrequency identification (RFID) is a simple, portable, real-time technology utilized to detect retained sponges during surgery. We investigated the feasibility of RFID to confirm the placement of ER-REBOA. Materials and Methods This was a single-arm prospective proof-of-concept experimental study approved by the institutional review board at Naval Medical Center San Diego. The ER-REBOA (Prytime Medical Devices, Inc, Boerne, TX, USA) was modified by placement of a RFID tag. The tagged ER-REBOA was placed in zone I or zone III of the aorta in a previously perfused cadaver. Exact location was documented with X-ray. Five blinded individuals used the RF Assure Detection System (Medtronic, Minneapolis, MN, USA) handheld detection wand to predict catheter tip location from the xiphoid process (zone I) or pubic tubercle (zone III). Results In zone I, actual distance (Da) of the catheter tip was 11 cm from the xiphoid process. Mean predicted distance (Dp) from Da was 1.52 cm (95% CI 1.19–1.85). In zone III, Da was 14 cm from the pubic tubercle. Mean Dp from Da was 4.11 cm (95% CI 3.68–4.54). Sensitivity of detection was 100% in both zones. Specificity (Defined as Dp within 2 cm of Da) was 86% in zone I and 16% in zone III. Conclusions Using RFID to confirm the placement of ER-REBOA is feasible with specificity highest in zone I. Future work should focus on refining this technology for the forward-deployed setting. REBOA, radiofrequency identification, placement, fluoroscopy-free INTRODUCTION Non-compressible torso hemorrhage (NCTH) remains a leading cause of death in the prehospital and forward-deployed setting.1,2 Resuscitative endovascular balloon occlusion of the aorta (REBOA) has been developed in response to this problem. This technology was first described during the Korean War but has only recently been embraced by the modern trauma community.3 REBOA has been shown to be an alternative to thoracotomy with aortic clamping in providing temporary control of NCTH but historically has been criticized for the advanced technical skill required, increased time to aortic occlusion, and complications associated with placement.4–6 In response to many of these criticisms, the ER-REBOA (Prytime Medical Devices, Boerne, TX, USA) was developed offering a more facile device that utilizes a smaller introducer sheath, an atraumatic pigtail catheter tip, and does not require a guidewire making placement even in the prehospital setting a possibility. However, definitive imaging to guide placement or, at a minimum, confirm placement in the target aortic zone once the balloon is inflated is still recommended by the company.7 Fluoroscopy has been the gold standard for this purpose but is not available in the prehospital environment limiting its use in this setting. Complete description of the ER-REBOA can be found at www.prytimemedical.com. Radiofrequency identification (RFID) is currently used to detect retained sponges within the body cavity after surgery. It is an extremely reliable technology described as 100% sensitive and specific among a wide array of body types.8 Given the established utility of RFID, we hypothesized its potential for use with REBOA. In this study, we aimed to investigate the feasibility and reliability of using RFID to detect placement of the ER-REBOA catheter in zone I and zone III of the aorta. METHODS This was a single-arm prospective proof-of-concept experimental study using a previously perfused cadaveric specimen. The study was performed at Naval Medical Center San Diego, San Diego, CA, USA. The protocol was approved by the hospital’s human research institutional review board and did not require informed consent. The cadaveric specimen was provided by the Department of Medical Education/Anatomical Services of the University of California, San Diego. Specimen use for this study was approved by the department in writing. A laparotomy sponge from the RF Assure (Medtronic, Minneapolis, MN, USA) kit was deconstructed and the RF tag removed. The tag was then affixed to the tip of the ER-REBOA catheter. Radiolucent markings were placed over the pelvis and thorax of the cadaver indicating 1 cm intervals from the pubic tubercle and xiphoid process. A left femoral cut-down and arteriotomy were performed. The modified ER-REBOA was placed into zone I of the aorta. Location was confirmed by X-ray imaging (Fig. 1) and this measurement was recorded as the actual distance zone I, Da1. Next, five individuals blinded to the placement of the catheter were instructed to wave the RF Assure wand over the specimen to predict location of the catheter tip (Fig. 2). Participants waved the wand once from a caudal direction and once from a cephalad direction. There was an audible beep from the RF Assure console when the device detected the RF tag. Based on position of the wand when the detector beeps were heard, participants predicted the location of the catheter tip and indicated their prediction by pointing to a radiolucent marking on the specimen. This measurement was recorded as the predicted distance, Dp. This defined one run. Measurements in zone I were described as distance from the xiphoid process in centimeters (cm). Each individual performed a set of 10 runs in zone 1 resulting in 50 predictions overall in zone I. The catheter tip was then repositioned into zone III with location confirmed by X-ray (Fig. 3) and this measurement recorded as actual distance zone III, Da3. The individuals were again blinded to catheter placement and were instructed to repeat the same process to predict placement as they did in zone I. Measurements in zone III were defined as distance in cm from the pubic tubercle. Each individual performed a set of 10 runs in zone III resulting in 50 predictions overall. FIGURE 1. Open in new tabDownload slide X-ray image of the modified ER-REBOA catheter tip in zone I. FIGURE 1. Open in new tabDownload slide X-ray image of the modified ER-REBOA catheter tip in zone I. FIGURE 2. Open in new tabDownload slide Participant using the RF Assure wand to predict placement of ER-REBOA. FIGURE 2. Open in new tabDownload slide Participant using the RF Assure wand to predict placement of ER-REBOA. FIGURE 3. Open in new tabDownload slide X-ray image of the modified ER-REBOA catheter tip in zone III. FIGURE 3. Open in new tabDownload slide X-ray image of the modified ER-REBOA catheter tip in zone III. RESULTS The cadaveric specimen was an 88-year-old-female with a body-mass index of 28. Da1 was 11 cm from the xiphoid process. In zone I, maximum Dp was 13 cm and minimum Dp was 8.5 cm. Table I summarizes the results for zone I placement. In zone III, Da3 was 14 cm from the pubic tubercle. Maximum Dp was 16 cm and minimum Dp was 8 cm. Table II summarizes the results for zone III placement. Sensitivity was defined as the presence of signal detection during an intended run and was 100%. Specificity was defined as Dp within 2 cm of actual distance. Specificity was 86% in zone I and 16% in zone III. Table I. Zone I Results . Set A . Set B . Set C . Set D . Set E . Total . Mean |Da1– Dp|a 1.35 2.4 0.8 1.25 1.8 1.52 Standard deviation 0.784 1.265 0.632 0.425 1.814 1.191 95% CI 0.486 0.784 0.392 0.263 0.815 0.33 Sensitivity 100% 100% 100% 100% 100% 100% Specificity 90% 60% 100% 100% 80% 86% . Set A . Set B . Set C . Set D . Set E . Total . Mean |Da1– Dp|a 1.35 2.4 0.8 1.25 1.8 1.52 Standard deviation 0.784 1.265 0.632 0.425 1.814 1.191 95% CI 0.486 0.784 0.392 0.263 0.815 0.33 Sensitivity 100% 100% 100% 100% 100% 100% Specificity 90% 60% 100% 100% 80% 86% aAbsolute value of the difference between actual distance (Da) and predicted distance (Dp) in cm. Open in new tab Table I. Zone I Results . Set A . Set B . Set C . Set D . Set E . Total . Mean |Da1– Dp|a 1.35 2.4 0.8 1.25 1.8 1.52 Standard deviation 0.784 1.265 0.632 0.425 1.814 1.191 95% CI 0.486 0.784 0.392 0.263 0.815 0.33 Sensitivity 100% 100% 100% 100% 100% 100% Specificity 90% 60% 100% 100% 80% 86% . Set A . Set B . Set C . Set D . Set E . Total . Mean |Da1– Dp|a 1.35 2.4 0.8 1.25 1.8 1.52 Standard deviation 0.784 1.265 0.632 0.425 1.814 1.191 95% CI 0.486 0.784 0.392 0.263 0.815 0.33 Sensitivity 100% 100% 100% 100% 100% 100% Specificity 90% 60% 100% 100% 80% 86% aAbsolute value of the difference between actual distance (Da) and predicted distance (Dp) in cm. Open in new tab Table II. Zone III Results . Set A . Set B . Set C . Set D . Set E . Total . Mean |Da3– Dp|a 2.2 4.75 5.6 4.0 4.0 4.11 Standard deviation 1.989 0.354 0.516 0.667 1.054 1.54 95% CI 1.232 0.219 0.32 0.413 0.653 0.427 Sensitivity 100% 100% 100% 100% 100% 100% Specificity 70% 0% 0% 0% 10% 16% . Set A . Set B . Set C . Set D . Set E . Total . Mean |Da3– Dp|a 2.2 4.75 5.6 4.0 4.0 4.11 Standard deviation 1.989 0.354 0.516 0.667 1.054 1.54 95% CI 1.232 0.219 0.32 0.413 0.653 0.427 Sensitivity 100% 100% 100% 100% 100% 100% Specificity 70% 0% 0% 0% 10% 16% aAbsolute value of the difference between actual distance (Da) and predicted distance (Dp) in cm. Open in new tab Table II. Zone III Results . Set A . Set B . Set C . Set D . Set E . Total . Mean |Da3– Dp|a 2.2 4.75 5.6 4.0 4.0 4.11 Standard deviation 1.989 0.354 0.516 0.667 1.054 1.54 95% CI 1.232 0.219 0.32 0.413 0.653 0.427 Sensitivity 100% 100% 100% 100% 100% 100% Specificity 70% 0% 0% 0% 10% 16% . Set A . Set B . Set C . Set D . Set E . Total . Mean |Da3– Dp|a 2.2 4.75 5.6 4.0 4.0 4.11 Standard deviation 1.989 0.354 0.516 0.667 1.054 1.54 95% CI 1.232 0.219 0.32 0.413 0.653 0.427 Sensitivity 100% 100% 100% 100% 100% 100% Specificity 70% 0% 0% 0% 10% 16% aAbsolute value of the difference between actual distance (Da) and predicted distance (Dp) in cm. Open in new tab DISCUSSION Our goal was to investigate the feasibility of RFID for detection of the ER-REBOA catheter tip given the high fidelity of this technology in various settings. We found sensitivity and specificity of detection in zone I were excellent at 100% and 86%, respectively. Sensitivity of prediction was also 100%, however, accuracy of zone III predictions was poor at 16% with a much wider range in predictions overall. With up to 70% of mortality on the modern battlefield resulting from massive truncal hemorrhage, there has been a concerted effort to identify methods to provide effective hemorrhage control as far forward, and close to the point of injury, as possible.1,9 Reducing transport time to less than 60 minutes along with placing damage control surgery teams as close to the point of injury as possible has resulted in up to 39% reduction in mortality.10,11 REBOA has been recognized as having the potential to play a large role in damage control resuscitation as well as temporarily addressing NCTH in prehospital settings.12–15 The development of the ER-REBOA catheter occurred as a military-civilian partnership.16 Use of the device has been studied in simulated tactical casualty evacuation scenarios using swine animal models and deemed feasible setting the stage for forward-deployed use.17 A case series of four human casualties of war presenting with class IV shock and positive FAST exam described placement of ER-REBOA in zone I (n = 3) or zone III (n = 1) by a U.S. Air Force Special Operations Surgical Team in an austere Role I setting. Placement was performed by either a general surgeon or an emergency medicine physician. Following the Joint Trauma System Clinical Practice Guidelines the device was positioned in zone I or III using fixed distances without image-guided confirmation of placement as imaging was not a capability of this setting.18 All patients demonstrated immediate improvement of systolic blood pressure after inflation. Aortic occlusion time ranged from 20–28 minutes in zone I and was 65 minutes in zone III while damage control surgery was performed. The device removed prior to transport to the next echelon of care in all. It was noted during a zone I occlusion, the balloon migrated distally necessitating deflation and repositioning. How it was known the balloon migrated given the lack of imaging, how far it distally migrated and the time spent at that location were not detailed. No other complications related to placement were observed and all casualties survived a 2-hour transport to the role II. Unfortunately, long-term outcomes for all patients were unknown.19 Given these findings, some in the military trauma community have been advocating for continued use in this setting and development of training pathways to make this possible.20 Despite the many previously described advantages of ER-REBOA, the manufacturer’s themselves advocate for image-guided confirmation of placement. This is typically accomplished by fluoroscopy or X-ray in the hospital setting. Actual and theoretical risks of not doing so include unintended placement in the aortic arch, renal artery, zone II or in the contralateral iliac. In previous literature, an attempt to develop a fluoroscopy-free device resulted in placement within the renal artery during testing in swine models.21 Studies have since investigated alternative means for confirming placement. Ultrasound was feasible in the hospital setting, however, relied on following the metallic guidewire which the ER-REBOA does not have.22,23 The ER-REBOA catheter tip has some echogenicity on ultrasound but the image quality could be obscured by the shrapnel and air that is often present in most combat casualties. Additionally, the utility of ultrasound in clinical settings is highly operator dependent, even for highly trained technicians. Therefore, although ultrasound is nearly ubiquitous, it may not be the best technology for this purpose. Thermal imaging for assessing limb perfusion after tourniquet and REBOA placement has been performed in animal models and found to be reliable even under simulated blackout combat conditions.24,25 This technology is based on a smartphone application and also uses the device for image capture highlighting the portability and possibility of use for REBOA placement in Role I settings. However, true accuracy in the hypothermic casualty is yet to be determined and still would unlikely be able to rule out placement above the ostia of the subclavian or into a renal artery. The most promising data currently show that using external body surface markers for placement can lead to reliable REBOA placement in zone I or zone III of the aorta. Retrospective analysis of computed tomographic scans of trauma patients demonstrated the presence of common segments within each respective aortic zone where deployment of the balloon is deemed safe.26 Other data show the measurement from the femoral artery to either the sternal notch or umbilicus result in reliable placement into the target zone.27,28 These results advocating for a fixed-distance model, while promising, cannot guarantee the catheter tip did not float into an unintended vessel. The results from our study propose a simple, reproducible, portable, and inexpensive method for detecting placement. In line with previous literature, RFID technology is extremely sensitive. The challenge lies in developing a device that achieves acceptable specificity. Specificity is affected by wavelength of the RF signal, body habitus, condition of the vessels (i.e. tortuosity), environmental factors and sensitivity of the detector. We found that, in a cadaver with a BMI of 28, prediction within 2 cm of the catheter tip was successful 86% of the time when placed in zone I, however only 16% of the time when in zone III. Several variables play a role in penetration of RF signal through biological tissue. These include (but are not limited to) signal frequency, tissue depth, water content and electrical conductance of the tissue.29 Decreased accuracy in zone III may be secondary to calcifications and tortuosity of the aorta as well as signal deflection by internal organs and the significant central adiposity of our specimen. Tolerance for variable specificity should be low in either zone given the consequences with malposition. We acknowledge the many nuances of appropriate REBOA placement beyond the logistics of doing so. The simple act of placing the ER-REBOA catheter is no more challenging than placing a femoral arterial line, which capable care providers are able to do with proper training. The difficulty in placement under austere conditions is more fundamental. It lies in deciding when placement is appropriate given the likely multiply injured casualty and lack of adjunctive imaging available in the Role I or II setting coupled with unknown transport times to definitive care. Any individual placing this device should be able to mindfully evaluate those considerations and have contingency plans in place as the surgical mission evolves. However, when placement is appropriately indicated, our results demonstrate the possibility of quick confirmation in zone I when traditional imaging modalities are unavailable. Further research should focus on improving the design of an RF-embedded REBOA catheter in an effort increase efficiency, reliability and safety. The limitations of this study include use of a single-cadaver who was elderly and female. This is in contrast to the young, healthy and (mostly) males of which represents our target population. Further studies should test this technology in a larger quantity of cadavers with an array of body types. This was a proof-of-concept study and therefore for cost-effectiveness a single-cadaver was used. We suspect specificity of detection will be improved in a young and otherwise healthy patient without significant vessel calcification or central adiposity to obscure signal penetrance. CONCLUSIONS In the new era of damage control surgery, ER-REBOA has the potential to temporarily mitigate massive truncal hemorrhage and avoid unnecessary loss of life. Although concern regarding appropriate use of the device remains, the logistics of placement in austere environments must be addressed. We have found that modifying the ER-REBOA catheter with RFID for detection in the target aortic zone is feasible. Further research should focus on developing the technology to achieve improved specificity of signal detection ACKNOWLEDGMENTS The authors wish to thank individuals who donate their bodies and tissues for the advancement of education and research. REFERENCES 1 Eastridge BJ , Mabry RL, Seguin P, et al. : Death on the battlefield (2001–2011) . J Trauma Acute Care Surg 2012 ; 73 ( 6 Suppl 5 ): S431 – 7 . doi:10.1097/TA.0b013e3182755dcc . 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Author notes The views expressed are solely those of the authors and do not reflect the official policy or position of the U.S. Navy, the Department of Defense, or the U.S. Government. Published by Oxford University Press on behalf of the Association of Military Surgeons of the United States 2018. This work is written by (a) US Government employee(s) and is in the public domain in the US. Published by Oxford University Press on behalf of the Association of Military Surgeons of the United States 2018.
TI - Radiofrequency Identification of the ER-REBOA: Confirmation of Placement Without Fluoroscopy
JF - Military Medicine
DO - 10.1093/milmed/usy187
DA - 2019-03-01
UR - https://www.deepdyve.com/lp/oxford-university-press/radiofrequency-identification-of-the-er-reboa-confirmation-of-W4Fu3H1Mrb
SP - e285
EP - e289
VL - 184
IS - 3-4
DP - DeepDyve
ER -