Degree project, 30 ECTS 2021-01-13
REBOA - have
mortality and complications changed
over time?
-
A comparison between years 2011-2015 and 2016-2020 Version 2Author: Gabriella Ruborg, MB School of Medical Sciences
Örebro University Örebro Sweden
Supervisor: David T. McGreevy, MD Department of Cardiothoracic and
Vascular Surgery Örebro University Hospital Örebro University Örebro Sweden Word count Abstract: 247 Manuscript: 3164
Abstract
Introduction
Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) is an invasive technique aimed at stabilizing hemodynamically unstable patients. The technique is under constant development andin 2016 a new REBOA balloon requiring a smaller sized sheath was introduced aiming to decrease complications and mortality. Studies show contradictory findings concerning outcome and complications of REBOA.
Aim
To investigate if survival and complications of patients treated with REBOA changed over time by comparing two time periods, 2011-2015 and 2016-2020.
Methods
This was a retrospective registry study. Data was extracted from the Aortic Balloon Occlusion (ABO) trauma registry and 217 patients were included in the study. Patients were divided into two calendar periods, an early period (2011-2015) and a late period (2016-2020).
Results
Mortality at the emergency department was 24 % in the early period compared to 9 % in the late period (p= 0.018). Mortality within 24 hours was reported in 40 % in the early period and 36 % in the late period. In the early period, mortality within 30 days was 59 % and 36 % in the late period. Access related complications such as extremity ischemia was reported in 1 % in the early period and 12 % in the late period (p = 0.001).
Conclusion
Early mortality at the emergency department has decreased over time. Access related
complications were present in both the early and late period but extremity ischemia was more common in the late period.
Abbreviations
ABO - Aortic Balloon Occlusion AS - Angio Suit
CFA - Common Femoral Artery CPR - Cardiopulmonary Resuscitation ED - Emergency Department
EDr - Emergency Doctor
EVTM- EndoVascular resuscitation and Trauma Management Fr - French
GS - General Surgeon
ICD - Intensive Care Doctor ICU - Intensive Care Unit IR - Interventional Radiologist ISS - Injury Severity Score IQR - Interquartile range
NCTH - Non-Compressible Torso Hemorrhage OR - Operation Room
pREBOA - partial REBOA
REBOA - Resuscitative Endovascular Balloon Occlusion of the Aorta RT - Resuscitative Thoracotomy
SBP - Systolic Blood Pressure TS - Trauma Surgeon
Introduction
In severe trauma, bleeding control is a critical strategy [1,2]. To remediate such cases, resuscitative thoracotomy (RT) with aortic clamping can be performed. However, an increasingly used alternative is resuscitative endovascular balloon occlusion of the aorta (REBOA) that until definitive hemostasis is achieved, can help control hemorrhage and support cerebral and cardiac perfusion [3–10] REBOA has evolved and gained popularity in both the military and civilian setting over the past several decades after initially being described by Hughes et al. during the Korean War [11–13]. The development of aortic balloons came with the progress of endovascular technology [14] but it was not until 1986 REBOA was described in the emergency medicine literature [11]. In modern trauma care, the technique is used worldwide and has recently been implemented in trauma medicine for critically injured patients according to the principles of EndoVascular resuscitation and Trauma Management (EVTM) [15–18]. There are three potential aortic occlusion zones related to REBOA. Zone 1, from the left subclavian artery to the celiac artery, zone 2 between the celiac artery and the lowest renal artery. Zone 3 is located between the lowest renal artery and the aortic bifurcation [19].
Previously, large diameter sheaths, 12 – 14 French (Fr), were required with REBOA use in the management of hemodynamic instability. Advances led to the development of 7 Fr
sheaths, introduced in the USA in 2016, facilitating the use of REBOA in trauma patients and may be the reason for an increase in utilization over time [20,21]. With the use of 12-14 Fr arterial sheaths, vascular complications were frequent, such as improper placement, distal limb ischemia and aorta dissection [20,22]. Complications for instance extremity ischemia may be related to the procedure and material, i.e the location of insertion and diameter of the larger sheath [22]. Expectations with the 7 Fr sheath were less vascular complications [20,23]. It has been reported that smaller sheaths for REBOA are effective and safe [24].
Multiple studies have focused on the evaluation of survival and complications after REBOA in general. Several reports of successful REBOA have been published but at the same time, the findings are incongruous concerning its effectiveness and its safety [25,26]. Despite an increased use of REBOA in recent years and a constant development in technique, there are few studies looking at how this has affected mortality and complications over time.
Aim
This study aimed to compare mortality and complications between two calendar periods, 2011-2015 and 2016-2020, to evaluate if mortality and complications after REBOA have changed over time.
Material and methods
This was a retrospective registry study using world-wide data from patients treated with REBOA.
Data source
Data was obtained from the Aortic Balloon Occlusion (ABO) trauma registry which is based in Sweden and contains data about REBOA treated patients from 25 institutions in 13
countries in South America, Asia and Europe. The registry was established in 2014 at Örebro University Hospital by the Department of Cardiothoracic and Vascular Surgery [27].
Patient groups
Inclusion criteria was the use of REBOA in traumatic hemorrhagic shock. Exclusion criteria was missing date of injury and sheath size 4-6 Fr. The study population was analyzed by comparing two calendar year periods: early period (2011-2015) and late period (2016-2020).
Variables and outcomes
Variables extracted from the registry were age, gender, comorbidity, type of injury, head injury, injury severity score (ISS), emergency department (ED) cardio pulmonary
resuscitation (CPR), systolic blood pressure (SBP) pre and post-REBOA, partial aortic occlusion (pREBOA), laparotomy, common femoral artery (CFA) access, CFA access
attempts, CFA access location, performing specialty, occlusion zone and inflation time. In the registry comorbidity was defined as presence of one or several diseases such as:
cardiovascular disease, previous intestinal surgery, previous intracranial hemorrhage, chronic renal failure, past or ongoing cytostatic treatment, respiratory disease, cerebral infarction, radiation therapy, gastrointestinal disease, epilepsy, cerebral disease, Parkinson´s disease, palliative care, renal disease, endocrine disease, malignancies and previous surgery. Primary outcome was mortality at the ED, mortality within 24 hours and mortality within 30 days. Complications such as signs of embolization, major access bleeding, hematoma at access site,
extremity ischemia and distal embolization due to REBOA, was the secondary outcome of this study.
Statistical analysis
Ordinal and continuous data was presented as median (interquartile range) and categorical data as numbers and percentages. To compare continuous or ordinal data, Mann-Whitney U test was used for two independent groups. Pearsons chi-square test or Fisher’s exact test was used for categorical data of two independent groups. A binary logistic regression analysis was performed regarding mortality and complications, to adjust for confounders such as age and comorbidities. A p value of < 0.05 was considered statistically significant. The analysis was performed using SPSS version 21 (IBM, Armonk, NY, USA).
Ethical considerations
The hospitals contributing with data received ethical approval from their own ethics committees and the regional ethics committee of Uppsala Sweden have approved the ABO trauma registry.
Results
A total of 266 patients were registered in the ABO trauma registry. Two-hundred and
seventeen patients were included with 49 patients excluded due to missing date of injury and 4-6 Fr sheaths (Fig. 1). An overview of patient demography and patient characteristics are presented in Table 1. The distribution of patients in the early period and late period was 85 and 132 patients, respectively. Within this cohort, 73 % were male. The median age was 45 years (IQR 27-63) and comorbidities were present in 28 % of the patients. A comparison between the early and late groups showed a statistically significant difference regarding age (p < 0.001) in which the early group had a median age of 57 (IQR 36-70) and the late group of 41 (27-60). Regarding comorbidity it was present in 45 % in the early group and in 17 % in the late group with a statistically significant difference (p <0.001). The most common type of injury was blunt trauma (81 %). Head injury was present in a total of 38 % of the patients. Median ISS was 38 (IQR 25-50). ED CPR was performed in 11 % of the patients.
Table 2 presents data regarding mortality. In the ED, 15% of patients died. There was a
mortality (p =0.018). Mortality within 24 hours was 37 % and mortality within 30 days was 51 % of all the patients and there was no statistically significant difference between the groups.
Access related complications were detected in both groups (Table 3). Signs of embolization was present in 6 % of the patients. Major access bleeding and hematoma at the access site were both present in 1 %. Extremity ischemia was reported in 8 %, 1% in the early group and 12 % in the late group (p =0.001). Distal embolization was reported in 2 %.
The majority of CFA access was performed blindly (53 %) (Table 4, appendix) (p <0.001). CFA access was in the majority of patients successful on the first attempt (58 %) and was primarily performed in the ED (49 %). The most common medical specialties who performed REBOA were ED doctors (68 %) in the early period and trauma surgeons (TS) (36 %) in the late period (p =0.001). Occlusion zone 1 was used in 73 % of the patients. Zone 2 was used in 4 %, and zone 3 in 19 % of the patients (p <0.001). Inflation time varied between 5 minutes and > 60 minutes. In 9 % of the early period and 3 % of the late period, inflation time was 5-10 minutes. In 8 % of the early period and 4 % of the late period, inflation time was 11-15 minutes. More than 60 minutes inflation time was used in 19 % of both the early and late period (p =0.005).
Logistic regression analysis was performed for each outcome to adjust for age and comorbidities. For ED mortality, Exp(B) for the early period was 2.575 and 95 % CI was 1.018-6.515 (p = 0.046). Exp(B) for mortality within 24 hours, was 1.207 and 95 % CI was 0.604-2.415 (p = 0.594). For mortality within 30 days Exp(B) was 0.948 and 95 % CI was 0.484-1.858 (p = 0.877).
Figure 1
Figure 1 demonstrates patients included and excluded in a flow chart.
Table 1
Patient characteristics are presented in table 1. Continuous variables are presented as median (IQR) and categorical variables are presented as numbers and percent, n (%). Mann-Whitney U test and Pearson chi-square test as appropriate.
Variable All (n=217) Early period (n=85) Late period (n=132) p Age, median years (IQR) 45 (27-63) 57 (36-70) 41 (27-60) <0.001
Male gender, n (%) 159 (73 %) 58 (68 %) 101 (77 %) 0.209 Comorbidity, n (%) 61 (28 %) 38 (45 %) 23 (17 %) <0.001 Type of injury 0.158 - Blunt, n (%) 175 (81 %) 74 (87 %) 101 (77 %) - Penetrating, n (%) 38 (18 %) 10 (12 %) 28 (21 %) Head injury, n (%) 83 (38 %) 37 (44 %) 46 (35 %) 0.253
ISS, median (IQR) 38 (25-50) 41 (29-51) 35 (25-51) 0.343
ED CPR, n (%) 24 (11 %) 11 (13 %) 13 (10 %) 0.365 SBP pre-REBOA, median mmHg (IQR) 55 (40-70) 60 (40-80) 50 (40-70) 0.064 SBP post-REBOA, median mmHg (IQR) 98 (80-120) 100 (90-129) 95 (80-111) 0.057 pREBOA, n (%) 99 (46 %) 36 (42 %) 63 (48 %) 0.197 Laparotomy, n (%) 101 (47 %) 33 (39 %) 68 (52 %) 0.495
IQR, interquartile range; ISS, injury severity score; ED, emergency department; CPR, cardiopulmonary resuscitation; SBP, systolic blood pressure; pREBOA, partial REBOA
Trauma patients registered in the ABO trauma registry from 2011-2020 n= 266 Study patients n =217 Exclusion n= 49 • Missing date of injury = 6 • Sheath 4-6 Fr = 43 Early period n= 85 Late period n=132
Table 2
Mortality presented in numbers and percent, n (%) using Pearson chi-square test.
ED, emergency department
Table 3
Access related complications are presented in numbers and percent, n (%) using Pearson chi-square test.
Discussion
This study aimed to examine if mortality and complications after REBOA have changed over time by comparing two time periods, 2011-2015 and 2016-2020. There are various causes to potential differences between these periods, however, the introduction of the 7 Fr sheaths was a dominating reason for the hypothesis that there could be a detectable difference. A
comparison between the two groups regarding ED mortality showed a statistically significant difference. REBOA related complications showed a significant increase in extremity ischemia in the late group.
When comparing ED mortality between the two groups, there was a statistically significant difference, however, results for 24 hours mortality and mortality within 30 days showed no statistically significant difference between the early and late period. This suggests that mortality in general has not improved. A similar comparison from a recent Japanese study showed an increased survival of patients treated with REBOA by comparing different time periods, 2004-2007, 2008-2011 and 2012-2015. The increased survival was achieved in the last period, and this was the first report to analyze the outcome of REBOA treated patients
Variable All (n=217) Early period
(n=85) Late period (n=132) p ED mortality, n (%) 32 (15 %) 20 (24 %) 12 (9 %) 0.018 24 hours mortality, n (%) 81 (37 %) 34 (40 %) 47 (36 %) 0.774 30 day mortality, n (%) 111 (51 %) 50 (59 %) 61 (46 %) 0.322 Variable All (n=217) Early period (n=85) Late period (n=132) p Signs of embolization, n (%) 12 (6 %) 1 (1 %) 11 (8 %) 0.106
Major access bleeding, n (%) 1 (1 %) 0 (0 %) 1 (1 %) 1.000
Hematoma at access site, n (%) 2 (1 %) 0 (0 %) 2 (2 %) 0.514
Extremity ischemia, n (%) 17 (8 %) 1 (1 %) 16 (12 %) 0.001
over an extended time period [15]. The result for the improved ED mortality in our study may indicate that the performance of REBOA could have improved over time, since REBOA is an emergency procedure in response to severe trauma. Though, it is important to take into consideration that trauma care in general may have improved and that there are several aspects on improved mortality at the emergency department. The conclusion that REBOA is the only factor contributing to improved survival could neither be drawn in the study from Japan previously mentioned, since overall survival among trauma patients in Japan increased [15]. In a previous study when smaller sheaths were compared to larger sheaths, 76 %
survived in the ED. Likewise, the results in this study correlate to previous findings that fewer early deaths are caused by hemorrhage for patients treated with REBOA [22].
The size of the different sheaths are important in the discussion. In a previous study, in which 7 Fr sheaths were evaluated, the survival rate was higher compared to previous experiences using larger devices. It was unclear if the improvement was affected by patient selection, how the procedure was performed or improvements in strategies and material [24]. A similar reasoning can be made in this study. In a registry study from 2019, it was shown that when using 7 Fr sheaths, both 24 hours and in hospital survival was improved [23]. However, results for mortality within 24 hours and 30 days in this study showed no statistically
significant difference between the early and late period. Numerical differences were detected and perhaps a larger group of patients would have resulted in significant differences.
Mortality depends on several factors including patient characteristics and the general care, beyond the specific medical intervention. A logistic regression analysis was therefore
performed to adjust for confounders such as age and comorbidity since there was a significant difference regarding these variables with a potential impact on the final result (Table 1). The results from the regression analysis confirmed the previous calculations in this study that there was a difference between the early and late period concering mortality ED.
The mortality is also affected by the performance of REBOA. Most accesses were performed in the ED in the late period. To create a vascular access in the ED means that it is preformed early in the process, which may improve survival but it may also be associated with
complications. Earlier placement of REBOA may also imply placement of REBOA in patients who do not actually need it. Since there was a significant difference between the two groups regarding CFA access location, it might not be possible to draw a certain conclusion. Perhaps several confounders beyond age and comorbidities would be appropriate to take into account,
such as CFA access, specialties who performed REBOA and location (Table 4). These factors could have been included in the regression analysis, however age and comorbidities were considered as independent factors of the performance, while the other factors are a part of the actual performance of REBOA. CPR was not an exclusion criteria in the present study and it is possible that it might affect the result. In a prospective observational study, Brenner et al. demonstrated that patients who do not require CPR before aortic occlusion may benefit most from REBOA [28]. Furthermore, different hospitals could imply different standards of care, which is illustrated by Manzano-Nunez et al. [25]. Additionally it is not known if the patients treated with REBOA had non-survivable injuries.
Complications due to REBOA was the secondary outcome of this report. One of the most striking differences among the results in this present study, was the differences concerning the access related complications between the early and the late group, showing increased
complications regarding extremity ischemia. A register study from 2019, in which the newer 7 Fr device was compared to the older 11-12 Fr devices, showed a lower risk of distal
thromboembolic events. It also showed possible benefits regarding survival and transfusion requirements. A lower rate of distal extremity embolism was observed due to 7 Fr device compared to 11-12 French [29]. In a report from 2019 the conclusion was that smaller sheaths may decrease complications due to arterial access [24]. In the present study the results,
surprisingly, point towards increased extremity ischemia in the late period. It is important to take into account that it may require a larger selection of patients to be able to draw a certain conclusion. Extremity ischemia is also a result depending on several aspects in multitrauma patients. In a previous study, there were no thromboembolic complications when smaller sheaths were used and theoretically, a decreased diameter may diminish turbulence in the artery and improve the blood flow to the lower extremity [22]. In this present study, signs of embolization were current in both groups, but there was no significant difference between the two groups.
This study presents a larger number of occlusion zone 3 in the late group compared to the early group. Placement choice of REBOA is a highly debated topic and depends on the injury pattern since zone 1 is located supraceliac and zone 3 infrarenal [30]. In this study, zone 3 was performed in 30 % in the late period compared to 2 % in the early period. This result indicates that zone 3 is a more common choice due to the development of REBOA, not just because of the type of injury. The fact that zone 1 was used more frequently in the early period compared
to the late period, may indicate that the patients in the early period were more injured. Furthermore it is unknown if there is reporting bias regarding the zones and if zone 1 is not reported to the same extent due to poorer results. On the other hand, zone 3 is probably more common since there is more knowledge about complications and therefore zone 3 is often used, if possible. In the past, it was probably more common to place REBOA in zone 1. The majority in the late group performed one access attempt which might indicate the use of different methods to locate CFA, compared to if access was created blindly. Comparing the early and late period, 74 % were created blindly in the early group and 40 % in the late period. To create access blindly may increase possible complications. In a previous study when smaller sheaths were compared to larger sheaths, ultrasound was used more frequently in the late period. It has been shown that the use of ultrasound for access of CFA improves success rate [22]. In the late group, the results show that there were more vascular and trauma surgeons who performed REBOA. There was also a greater spread between different specialties who performed the access. It leads the discussion to whereas the different specialties and the performance affects the outcome.
In addition to potential sources of error previously mentioned, this study has other limitations which have to be taken into consideration. The different participating centers have a variance regarding experiences with this procedure. Furthermore, the procedure has also changed over time and is affected by technological advances as well as experiences of the performer. In the interpretation of this report, this knowledge must be considered as already established. Demographic comparison (Table 1) shows a significant difference between the early and late period regarding age and comorbidity that could affect the outcome. In the ABO trauma registry, the comorbidities are not specified and therefore it is difficult to draw a certain conclusion about the specific effect on the outcome. The registry contains information that has been given from different medical centers which means that sources of error are possible in the reporting procedures. Since the registry was created in 2014, data between 2011-2014 was collected retrospectively, which also makes the data during this period uncertain. There could also be elements of care that are not available in the registry which might contribute to complications. Despite the fact that the smaller sheaths were established principally in 2016, the registry contains data in which 7 Fr was used before 2016 in some cases which could have an impact on the interpretation of the result. However, the purpose with this study was to identify if there was a difference between the two time periods regarding mortality and complications in general due to various causes, not to evaluate the different sheath sizes
solely. Even though the study has limitations there are also strengths, for example this study is a multicenter study with a relatively large study population from different parts of the world.
Conclusion
In conclusion, there is a difference between the two time periods examined, regarding mortality ED and extremity ischemia. The results showed a decreased mortality in the ED although no statistical significant results regarding mortality within 24 hours and 30 days were observed. Access related complications were present in both the early and late period, but showed increased frequency of extremity ischemia in the late period. Further studies are required to draw a firm conclusion about the optimal use of REBOA in trauma care.
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Appendix
Table 4
Procedure variables presented in numbers and percent, n (%) using Pearson chi-square test.
Variable All (n=217) Early period (n=85) Late period (n=132) p CFA access <0.001 - Blind, n (%) 116 (53 %) 63 (74 %) 53 (40 %) - Ultrasound, n (%) 38 (18 %) 1 (1 %) 37 (28 %) - Cut down, n (%) 7 (3 %) 3 (4 %) 4 (3 %) - Fluoroscopy, n (%) 43 (20 %) 12 (14 %) 31 (23 %)
CFA access attempts 0.124
- 1, n (%) 125 (58 %) 36 (42 %) 89 (67 %)
- 2-3, n (%) 47 (22 %) 22 (26 %) 25 (19 %)
- >3, n (%) 8 (4 %) 2 (2 %) 6 (5 %)
CFA access location 0.001
- ED, n (%) 107 (49 %) 31 (36 %) 76 (58 %) - OR, n (%) 82 (38 %) 35 (41 %) 47 (36 %) - AS, n (%) 16 (7 %) 9 (11 %) 7 (5 %) - ICU, n (%) 6 (3 %) 6 (7 %) 0 (0 %) Performing specialty 0.001 - VS, n (%) 47 (22 %) 16 (19 %) 31 (23 %) - IR, n (%) 20 (9 %) 2 (2 %) 18 (14 %) - EDr, n (%) 70 (32 %) 58 (68 %) 12 (9 %) - TS, n (%) 52 (24 %) 5 (6 %) 47 (36 %) - GS, n (%) 9 (4 %) 2 (2 %) 7 (5 %) - ICD, n (%) 14 (6 %) 2 (2 %) 12 (9 %) Occlusion Zone <0.001 - Zone 1, n (%) 159 (73 %) 79 (93 %) 80 (61 %) - Zone 2, n (%) 8 (4 %) 4 (5 %) 4 (3 %) - Zone 3, n (%) 42 (19 %) 2 (2 %) 40 (30 %)
Inflation time (min) 0.005
- 5-10, n (%) 12 (6 %) 8 (9 %) 4 (3 %)
- 11-15, n (%) 12 (6 %) 7 (8 %) 5 (4 %)
- 16-20, n (%) 14 (6 %) 1 (1 %) 13 (10 %)
- 21-30, n (%) 17 (8%) 6 (7 %) 11 (8 %)
- 41-50, n (%) 29 (13 %) 11 (13 %) 18 (14 %)
- 51-60, n (%) 18 (8 %) 3 (4 %) 15 (11 %)
- >60, n (%) 41 (19 %) 16 (19 %) 25 (19 %)
CFA, common femoral artery; ED, emergency department; OR, operation room; AS, angio suit; ICU, intensive care unit; VS, vascular surgeon; IR, interventional radiologist; EDr, emergency doctor; TS, trauma surgeon; GS, general surgeon; ICD, intensive care doctor
Etisk reflektion
Att förbättra medicinska kunskaper är av stort värde men kräver noggrann genomgång av möjliga etiska fallgropar. Det är av största vikt att forskningen bedrivs på ett sådant sätt att ingen kommer till skada, vilket dessutom är en av de viktigaste värdegrunderna i läkaryrket. I denna registerstudie finns ett etiskt godkännande från vart och ett av länderna. Regionala etiska kommittén i Uppsala har även godkänt registret samt att GDPRformulär är ifyllt. Kan deltagande personer i registret trots detta komma till skada i en studie som denna är ändå frågan man måste ställa sig. Deltagarna är skyddade utifrån sekretessprinciper, inga patienter kan identifieras och kodnyckel finns bevarad utom räckhåll. Trots att data är kodad är
REBOA dock ett relativt ovanligt ingrepp. Detta innebär att det kan finnas variabler som går att känna igen, t.ex. på vilket sätt en person skadats. Dessutom utförs proceduren i Sverige framför allt i Örebro och inte i samma utsträckning i t.ex. Göteborg och Stockholm vilket ökar en eventuell risk för identifiering. Trots ett generellt etiskt godkännande finns det en risk att de inblandade eller deras anhöriga i de olika länderna inte själva godkänt att de finns med i registret. En studie som denna bidrar med ny kunskap kring REBOA men nytta måste alltid vägas mot riskerna. Data måste alltså hanteras varsamt och samtliga inblandade bör tänka igenom de etiska riskerna flera gånger extra inför en studie som denna.
Populärvetenskaplig sammanfattning
REBOA är ett ingrepp som relativt nyligen applicerats inom traumavården. Det finns dock motsägelsefulla rapporter när det gäller mortalitet och komplikationer efter
REBOA. Mer forskning behövs för att kunna säkerställa optimala omständigheter kring interventionen.
REBOA är en metod som beskrevs för första gången på 1950-talet. Relativt nyligen har metoden applicerats inom traumavården och syftar till att stabilisera patienter som drabbats av stora blödningar i buk och bäcken. Metoden går ut på att föra in REBOA katetern via en ledare i ljumsken, varvid ballong belägen på ena änden av katetern blåses upp. På så sätt stoppas blödningen samtidigt som blodcirkulationen ökar till hjärnan och till hjärtat. Ledaren har med tiden tillverkats i en mindre storlek i hopp om att kunna minska antalet
komplikationer.
Studien syftade till att undersöka om mortalitet och komplikationer efter REBOA har förändrats över tid genom att jämföra tidsperioderna 2011-2015 och 2016-2020 med utgångspunkt från ett internationellt register etablerat på Universitetssjukhuset i Örebro. Variabler relaterade till frågeställningen valdes ut från registret och patienter delades upp i två grupper utifrån de två tidsperioderna för att detektera eventuella skillnader gällande utfall i form av mortalitet och komplikationer.
Resultatet indikerar att mortaliteten på akuten i samband med REBOA minskat den senare perioden jämfört med den tidiga och att det fanns en tendens till ökade komplikationer i form av extremititesischemi.
Editorial Office
European Journal of Trauma 26-12-2020
Dear Sir/Madam,
We wish to submit an original research article entitled ”REBOA- have mortality and
complications changed over time?- A comparison between years 2011-2015 and 2016-2020” for publication in the European Journal of Trauma. In this registry study of patients who received REBOA, complications and outcome have been investigated. We have found that mortality at the emergency department has decreased but not survival in general. Extremity ischemia is a complication which has increased. This study is one of few evaluating
complications and outcome of REBOA by comparing different time periods. We believe this study brings new and useful information for studies in the future.
This work has not been published and is an original work. The manuscript is approved by the authors. There are no conflicts of interest that could inappropriately influence our work. Our hope is that you will considerer publishing this manuscript in your journal.
Sincerely, Corresponding author, Gabriella Ruborg MB Örebro University Örebro Sweden
