To Örebro University

OBJECTIVE: Open repair of ruptured abdominal aortic aneurysms (rAAA) has been increasingly replaced by endovascular aortic repair (EVAR) in many centers. Despite being a minimally invasive procedure, EVAR is associated with a risk of abdominal compartment syndrome (ACS), which can lead to significant morbidity and mortality. This study examines the incidence and clinical manifestation of ACS in a consecutive cohort of rAAA patients treated exclusively with EVAR at Örebro University Hospital over a 12-year period.

METHODS: This is a retrospective analysis of prospectively collected data. We identified 139 patients who had presented to Örebro University Hospital with rAAA between October 2009 and September 2021. Patients with isolated iliac artery, thoracic and thoracoabdominal aortic ruptures, previous aortic interventions (open or endovascular), and patients receiving palliative treatment were excluded. Patients developing ACS after rAAA were compared with those who did not develop ACS.

RESULTS: A total of 100 patients treated using EVAR were included in this study. ACS was identified in 17 patients, and these were compared with 83 patients who did not develop ACS. Mortality at 30 days was 53% in the ACS group (9/17) and 22% in the No-ACS group (18/83, p = 0.015). Regression analysis showed that advanced age and ACS were independent risk factors for death, with ACS increasing the hazard 4-fold (HR 4.26, CI 1.99-9.10, p < 0.001) and age increasing the hazard by 6% for every year (HR 1.06, CI 1.06-1.1, p = 0.004). The use of aortic balloon occlusion was not independently associated with the development of ACS.

CONCLUSIONS: ACS is a life-threatening complication of rAAA treated using EVAR and a significant number of patients developed ACS with high mortality and complication rates. All rAAA patients treated using EVAR should be monitored closely for ACS and treatment with decompressive laparotomy should be initiated without delay.Clinical ImpactOpen repair of ruptured abdominal aortic aneurysms (rAAA) has been increasingly replaced by endovascular aortic repair (EVAR). Despite being a minimally invasive procedure, EVAR is associated with a risk of abdominal compartment syndrome (ACS), which can lead to significant morbidity and mortality This article investigates abdominal compartment syndrome (ACS) in a cohort of total endovascular treated rAAA in a single centre and the treatment as well as the results, and gives insight on ACS in this patient group and might contribute to better understanding how to treat them and avoid this life-threatening complication.

OBJECTIVE: To report on the recommendations of an expert-based consensus on the indications, timing, and techniques of aortic balloon occlusion (ABO) in the management of ruptured abdominal aortic aneurysms (rAAA).

METHODS: Eleven facilitators created appropriate statements regarding the study issues that were voted on using a 4-point Likert scale with open-comment fields, by a selected panel of international experts (vascular surgeons and interventional radiologists) using a 3-round modified Delphi consensus procedure (study period: January-April 2023). Based on the experts' responses, only the statements reaching grade A (full agreement ≥75%) or B (overall agreement ≥80% and full disagreement <5%) were included in the final study report. The consistency of each round's answers was also graded using Cohen's kappa, the intraclass correlation coefficient, and, in case of double resubmission, Fleiss kappa.

RESULTS: Sixty-three experts were included in the final analysis and voted on 25 statements related to indication and timing (n=6), and techniques (n=19) of ABO in the setting of rAAA. Femoral sheath or ABO should be preferably placed in the operating room, via a percutaneous transfemoral access, on a stiff wire (grade B, consistency I), ABO placement should be suprarenal and last less than 30 minutes (grade B, consistency II), postoperative peripheral vascular status (grade A, consistency II) and laboratory testing every 6 to 12 hours (grade B, consistency) should be assessed to detect complications. Formal training for ABO should be implemented (grade B, consistency I). Most of the statements in this international expert-based Delphi consensus study might guide current choices for indications, timing, and techniques of ABO in the management of rAAA. Clinical practice guidelines should incorporate dedicated statements that can guide clinicians in decision-making.

CONCLUSIONS: At arrival and during both open or endovascular procedures for rAAA, selective use of intra-aortic balloon occlusion is recommended, and it should be performed preferably by the treating physician in aortic pathology.

CLINICAL IMPACT: This is the first consensus study of international vascular experts aimed at defining the indications, timing, and techniques of optimal use of ABO in the clinical setting of rAAA. Aortic occlusion by endovascular means (or ABO) is a quick procedure in properly trained hands that may play an important role as a temporizing measure until the definitive aortic repair is achieved, whether by endovascular or open means. Since data on its use in hemodynamically unstable patients are limited in the literature, owing to practical challenges in the performance of well-conducted prospective studies, understanding real-world use by experts is of importance in addressing critical issues and identifying main gaps in knowledge.

INTRODUCTION: Peripheral arterial disease (PAD), including intermittent claudication (IC) or critical limb ischemia (CLI), can be treated with endovascular revascularization; however, tools for intraoperative prognostication are limited. The In-Vivo Optical Spectroscopy (INVOS) system, a non-invasive near-infrared spectroscopy device, measures tissue oxygenation. This pilot study aims to investigate the use of INVOS during endovascular surgery for PAD as a prognostic tool for endovascular PAD treatment. This study is intended as a feasibility and hypothesis-generating pilot, rather than one designed to draw definitive conclusions.

METHODS: Thirty patients with PAD undergoing endovascular treatment were prospectively enrolled. In-Vivo Optical Spectroscopy sensors were applied to the treated foot preoperatively. Measurements were recorded preoperatively, postoperatively, and at 1, 2, and 3 hours post-surgery. Raw INVOS values and INVOS/systolic blood pressure (SBP) ratios were calculated and normalized to baseline values to determine fold changes. Clinical outcomes were assessed at 30 days.

RESULTS: No significant changes in raw INVOS or SBP values were observed before or after the procedure in both IC and CLI groups. However, the normalized INVOS/SBP ratio was significantly higher in IC patients at 1 and 2 hours postoperatively (p<0.05). A fold change greater than 1.25 was associated with better clinical outcomes, including fewer complications and higher rates of patient- and physician-reported improvement.

CONCLUSION: An INVOS/SBP ratio fold change greater than 1.25-fold is associated with improved outcomes following endovascular intervention for PAD. In-Vivo Optical Spectroscopy may serve as a valuable intraoperative prognostic tool, particularly in IC patients. Further studies are needed to validate these findings.Clinical ImpactThe clinical impact of the current work is to improve the knowledge in the application of INVOS measurements peri operative in clinical practices and improve patients care. Post operative surveillance with INVOS could be used to confirm surgical success. INVOS ratio lower than 1.25-fold after first revascularization should be reassessed and improve blood flow towards the limb. Although limited, this pilot study shows that the use of INVOS can be an adjuvanted tool in monitoring surgical outcomes in patients with PAD.

BACKGROUND: Drug-coated devices are frequently used in coronary and peripheral interventions, but their effect on amputation risk in peripheral artery disease is unclear. We assessed whether drug-coated devices affect the rate of above-ankle amputation in patients with chronic limb-threatening ischaemia undergoing infrainguinal endovascular revascularisation.

METHODS: The Swedish Drug-Elution Trial in Peripheral Arterial Disease 1 (SWEDEPAD 1) was a pragmatic, nationwide, multicentre, participant-masked, registry-based, randomised controlled trial at 22 Swedish centres. Adult patients with Rutherford category 4-6 peripheral artery disease scheduled for infrainguinal endovascular treatment were eligible for inclusion. Participants were randomly allocated in a 1:1 ratio after successful guidewire crossing to receive either paclitaxel-coated or uncoated balloons or stents. Randomisation was stratified by centre and performed using a computer-generated sequence with allocation concealment via a secure, registry-embedded web system. The primary efficacy endpoint was ipsilateral major amputation (above the ankle) during follow-up. All analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT02051088) and the primary analysis is complete; further analyses are ongoing.

FINDINGS: From Nov 5, 2014, to Sept 29, 2023, 2400 patients were randomly assigned to treatment with paclitaxel-coated devices (n=1206) or with uncoated devices (n=1194). 2355 patients were included in the intention-to-treat analysis (1180 in the paclitaxel-coated group and 1175 in the uncoated group). The median age was 77 years (IQR 71-83), 1317 (55·9%) of 2355 patients were male and 1038 (44·1%) were female, and 1237 (52·6%) patients had preoperative diabetes. Median follow-up was 2·67 years (IQR 1·08-4·78). Most patients (1761 [74·9%] of 2351) had wounds or tissue loss (Rutherford stage 5 or 6). Treated lesions were located in the femoropopliteal vascular segment in 1241 (52·7%) of 2355 patients, in the infrapopliteal segment in 537 (22·8%) patients, and in both segments in 561 (23·8%) patients. Nearly all paclitaxel-coated devices (>99%) used paclitaxel as the coating agent (>99%). There was no significant difference in the rate of ipsilateral major amputation between using paclitaxel-coated or uncoated devices (hazard ratio [HR] 1·05 [95% CI 0·87-1·27]; p=0·61) with maximum of 5 years of follow-up. There was no difference in all-cause mortality (HR 1·04 [95% CI 0·92-1·17]; p=0·54).

INTERPRETATION: In patients with chronic limb-threatening ischaemia undergoing infrainguinal endovascular revascularisation, paclitaxel-coated devices did not reduce major ipsilateral amputations.

BACKGROUND: Drug-coated devices are widely used to reduce restenosis after lower limb revascularisation in patients with peripheral artery disease, but their effect on patient-centred outcomes remains unclear. We assessed the effect of paclitaxel-coated devices on clinically important outcomes in patients with intermittent claudication undergoing infrainguinal endovascular revascularisation.

METHODS: The Swedish Drug-Elution Trial in Peripheral Arterial Disease 2 (SWEDEPAD 2) was a pragmatic, nationwide, multicentre, participant-masked, registry-based, randomised controlled trial conducted at 22 Swedish vascular centres. Adults 18 years or older with intermittent claudication (Rutherford categories 1-3) undergoing infrainguinal endovascular treatment and with no acute thromboembolic disease of the lower limb or infrainguinal aneurysmal disease were eligible for inclusion. Participants were randomly assigned in a 1:1 ratio after successful guidewire crossing to receive either paclitaxel-coated devices or uncoated balloons or stents. Randomisation was stratified by centre and performed using a computer-generated sequence with allocation concealment via a secure, registry-embedded web system. The primary efficacy endpoint was the between-group difference in quality of life at 1 year, assessed with the six-item Vascular Quality of Life Questionnaire (VascuQoL-6), a peripheral artery disease-specific quality of life instrument. The trial is registered at ClinicalTrials.gov (NCT02051088) and the primary analysis is complete; further analyses are ongoing.

FINDINGS: Between Nov 5, 2014, and Sept 27, 2023, a total of 1155 patients were enrolled and randomly assigned across 22 vascular centres in Sweden, of whom 1136 (98·3%) had follow-up data available for analysis. 577 patients were randomly assigned to paclitaxel-coated devices and 578 to uncoated devices, of whom 565 (97·9%) and 571 (98·7%) were included in the intention-to-treat population, respectively. The median age in the analysed cohort was 73·0 years (IQR 68·0-78·0). Of the 1136 patients, 612 (53·9%) were male and 524 (46·1%) were female; and 382 (33·7%) of 1135 had preoperative diabetes (one participant in the paclitaxel-coated device group was missing data). Most patients (677 [59·6%] of 1135) presented with severe claudication (Rutherford category 3). Femoropopliteal interventions were performed in 1092 patients (96·1%). At 1 year, VascuQoL-6 scores did not differ between groups (mean difference -0·02 [95% CI -0·66 to 0·62]; p=0·96). All-cause mortality did not differ over a median 7·1 years (IQR 3·9-8·2); hazard ratio (HR) 1·18 (95% CI 0·94-1·48); p=0·16, although 5-year mortality incidence was higher in patients randomly assigned to the paclitaxel-coated devices group (4·57 vs 3·28 per 100 person-years; HR 1·47 [95% CI 1·09-1·98]; p=0·010).

INTERPRETATION: In patients with Rutherford stage 1-3 peripheral artery disease undergoing infrainguinal endovascular revascularisation, paclitaxel-coated devices did not improve disease-specific quality of life at 1 year compared with uncoated devices. All-cause mortality was not different over the total follow-up time, but significantly higher over 5 years. These findings do not support routine use of paclitaxel-coated devices in this patient population.

Introduction: Endovascular treatment of iliac aneurysms with sparing of the internal iliac arterial circulation is feasible with iliac branch devices. However, insufficient distal seal with the endovascular devices on the market can be challenging. In this case, the anatomy was complex due to the extent of the aneurysms, and the available technical options were limited.

Report: A 65 year old man with aneurysms in the left common iliac (43 mm) and bilateral internal iliac arteries (right 41 mm; left 49 mm) was treated with an aortobi-iliac stent graft and bilateral iliac branch devices with extensions to opposing anterior (right) and posterior (left) branches of the internal iliac artery through staged interventions. At six weeks of follow up all treated aneurysms had decreased or were stable in size. Clinical signs of right sided gluteal claudication were evident at six weeks of follow up but no symptoms remained 20 weeks post-operatively.

Discussion: The presented case illustrates a technique to preserve pelvic circulation in a case of bilateral common and internal iliac arterial aneurysms. Extensions of the internal iliac limb of the iliac branch device, into the opposing anterior and posterior divisions of the internal iliac artery, may offer a strategy to reduce pelvic ischaemia in scenarios where the anatomy limits the use of standard iliac branch devices.

BACKGROUND: Systolic blood pressure (SBP) is a potential indicator that could guide when to use a resuscitative endovascular balloon occlusion of the aorta (REBOA) in trauma patients with life-threatening injuries. This study aims to determine the optimal SBP threshold for REBOA placement by analyzing the association between SBP pre-REBOA and 24-hour mortality in severely injured hemodynamically unstable trauma patients.

METHODS: We performed a pooled analysis of the Aortic Balloon Occlusion (ABO) trauma and AORTA registries. These databases record the details related to the use of REBOA and include data from 14 countries worldwide. We included patients who had suffered penetrating and/or blunt trauma. Patients who arrived at the hospital with a SBP pre-REBOA of 0 mm Hg and remained at 0 mm Hg after balloon inflation were excluded. We evaluated the impact that SBP pre-REBOA had on the probability of death in the first 24 hours.

RESULTS: A total of 1107 patients underwent endovascular aortic occlusion, of these, 848 met inclusion criteria. The median age was 44 years [IQR, 27-59 years] and 643(76%) were male. The median injury severity score was 34 [IQR, 25-45]. The median SBP pre-REBOA was 65 mm Hg [IQR: 49-88 mm Hg]. Mortality at 24-hours was reported in 279 (32%) patients. Math modelling shows that predicted probabilities of the primary outcome increased steadily in SBP pre-REBOA below 100 mm Hg. Multivariable mixed-effects analysis shows that when SBP pre-REBOA was lower than 60 mm Hg, the risk of death was more than 50% (relative risk, 1.5; 95%CI, 1.17-1.92; P = .001).

DISCUSSION: In patients who do not respond to initial resuscitation, the use of REBOA in SBP's between 60- and 80-mm Hg may be a useful tool in resuscitation efforts before further decompensation or complete cardiovascular collapse. The findings from our study are clinically important as a first step in identifying candidates for REBOA.

STUDY TYPE: Observational Study. LEVEL OF EVIDENCE: Level IV.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a method for temporary hemorrhage control used in haemodynamically unwell patients with severe bleeding. In haemodynamically unwell abdominal trauma patients, laparotomy remains the initial procedure of choice. Using REBOA in patients as a bridge to laparotomy is a novel option whose feasibility and efficacy remain unclear. We aimed to assess the clinical outcome in patients with abdominal injury who underwent both REBOA placement and laparotomy.

METHODS: This is a retrospective study, including trauma patients with an isolated abdominal injury who underwent both REBOA placement and laparotomy, during the period 2011-2019. All data were collected via the Aortic Balloon Occlusion Trauma Registry database.

RESULTS: One hundred and three patients were included in this study. The main mechanism of trauma was blunt injury (62.1%) and the median injury severity score (ISS) was 33 (14-74). Renal failure and multi-organ dysfunction syndrome (MODS) occurred in 15.5% and 35% of patients, respectively. Overall, 30-day mortality was 50.5%. Post balloon inflation systolic blood pressure (SBP) >80 mmHg was associated with lower 24-h mortality (p = 0.007). No differences in mortality were found among patients who underwent partial occlusion vs. total occlusion of the aorta.

CONCLUSIONS: Our results support the feasibility of REBOA use in patients with isolated abdominal injury, with survival rates similar to previous reports for haemodynamically unstable abdominal trauma patients. Post-balloon inflation SBP >80 mmHg was associated with a significant reduction in 24-h mortality rates, but not 30-day mortality. Total aortic occlusion was not associated with increased mortality, MODS, and complication rates compared with partial occlusion.

OBJECTIVE: This study aimed to investigate the association between intestinal fatty acid-binding protein, acute gastrointestinal injury grade, and gastrointestinal complications after fenestrated or branched endovascular aortic aneurysm repair.

METHODS: A total of 17 patients undergoing endovascular aortic repair for thoracoabdominal, juxtarenal, suprarenal or pararenal aneurysm between May 2017 and September 2018 were enrolled. Blood samples were collected preoperatively and during postoperative intensive care. The blood samples were analyzed for intestinal fatty acid-binding protein with enzyme-linked immunosorbent assay. Gastrointestinal function was assessed according to the acute gastrointestinal injury grade every day during postoperative intensive care.

RESULTS: Higher concentrations of intestinal fatty acid-binding protein at 24 h and 48 h correlated to higher acute gastrointestinal injury grade on postoperative days 1, 2 and 3 (p=0.032 and p=0.048, p=0.040 and p=0.018, and p=0.012 and p=0.016, respectively). Patients who developed a gastrointestinal complication within 90 days postoperatively had a higher overall acute gastrointestinal injury grade than those who did not develop a gastrointestinal complication (p<0.001), as well as higher concentrations of intestinal fatty acid-binding protein at 48 h (p=0.019). Patients developing gastrointestinal dysfunction (acute gastrointestinal injury grade ≥2) had a higher frequency of complications (p=0.009) and longer length of stay in the intensive care unit (p=0.008).

CONCLUSIONS: In patients undergoing endovascular aortic repair for complex aneurysm increased postoperative plasma intestinal fatty acid-binding protein concentrations and postoperative gastrointestinal dysfunction, evaluated using the acute gastrointestinal injury grade, were associated with gastrointestinal complications, indicating that these measures may be useful in the postoperative management of these patients.