Telemedicine-Guided Two-Incision Lower Leg Fasciotomy Performed by Combat Medics During Tactical Combat Casualty Care: A Feasibility Study.

INTRODUCTION: During tactical combat casualty care, life- and limb-saving procedures might also be performed by combat medics. This study assesses whether it is feasible to use a head-mounted display (HMD) to provide telemedicine (TM) support from a consulted senior surgeon for combat medics when performing a two-incision lower leg fasciotomy. MATERIALS AND METHODS: Nine combat medics were randomized into groups to perform a two-incision lower leg fasciotomy. One group used the Vuzix M400 and the second group used the RealWear HMT-1Z1. A third, control, group received no guidance. In the Vuzix M400 group and RealWear HMT-1Z1 group, a senior surgeon examined the results after the two-incision lower leg fasciotomy was finished to assess the release of compartments, possible collateral damage, and performance of the combat medics. In the control group, these results were examined by a surgical resident with expertise in two-incision lower leg fasciotomies. The resident's operative performance questionnaire was used to score the performance of the combat medics. The telehealth usability questionnaire was used to evaluate the usability of the HMDs as perceived by the combat medics. RESULTS: Combat medics using an HMD were considered competent in performing a two-incision lower leg fasciotomy (Vuzix: median 3 [range 0], RealWear: median 3 [range 1]). These combat medics had a significantly better score in their ability to adapt to anatomical variances compared to the control group (Vuzix: median 3 [range 0], RealWear: median 3 [range 0], control: median 1 [range 0]; P = .018). Combat medics using an HMD were faster than combat medics in the control group (Vuzix: mean 14:14 [SD 3:41], RealWear: mean 15:42 [SD 1:58], control: mean 17:45 [SD 2:02]; P = .340). The overall satisfaction with both HMDs was 5 out of 7 (Vuzix: median 5 [range 0], RealWear: median 5 [range 1]; P = .317). CONCLUSIONS: This study shows that it is feasible to use an HMD to provide TM support performance from a consulted senior surgeon for combat medics when performing a two-incision lower leg fasciotomy. The results of this study suggest that TM support might be useful for combat medics during tactical combat casualty care when performing life- and limb-saving procedures.

Editor's Choice - Nationwide Analysis of Patients Undergoing Iliac Artery Aneurysm Repair in the Netherlands.

OBJECTIVE: The new 2019 guideline of the European Society for Vascular Surgery (ESVS) recommends consideration for elective iliac artery aneurysm (eIAA) repair when the iliac diameter exceeds 3.5 cm, as opposed to 3.0 cm previously. The current study assessed diameters at time of eIAA repair and ruptured IAA (rIAA) repair and compared clinical outcomes after open surgical repair (OSR) and endovascular aneurysm repair (EVAR). METHODS: This retrospective observational study used the nationwide Dutch Surgical Aneurysm Audit (DSAA) registry that includes all patients who undergo aorto-iliac aneurysm repair in the Netherlands. All patients who underwent primary IAA repair between 1 January 2014 and 1 January 2018 were included. Diameters at time of eIAA and rIAA repair were compared in a descriptive fashion. The anatomical location of the IAA was not registered in the registry. Patient characteristics and outcomes of OSR and EVAR were compared with appropriate statistical tests. RESULTS: The DSAA registry comprised 974 patients who underwent IAA repair. A total of 851 patients were included after exclusion of patients undergoing revision surgery and patients with missing essential variables. eIAA repair was carried out in 713 patients, rIAA repair in 102, and symptomatic IAA repair in 36. OSR was performed in 205, EVAR in 618, and hybrid repairs and conversions in 28. The median maximum IAA diameter at the time of eIAA and rIAA repair was 43 (IQR 38-50) mm and 68 (IQR 58-85) mm, respectively. Mortality was 1.3% (95% CI 0.7-2.4) after eIAA repair and 25.5% (95% CI 18.0-34.7) after rIAA repair. Mortality was not significantly different between the OSR and EVAR subgroups. Elective OSR was associated with significantly more complications than EVAR (intra-operative: 9.8% vs. 3.6%, post-operative: 34.0% vs. 13.8%, respectively). CONCLUSION: In the Netherlands, most eIAA repairs are performed at diameters larger than recommended by the ESVS guideline. These findings appear to support the recent increase in the threshold diameter for eIAA repair.

Consensus on resuscitative endovascular balloon occlusion of the Aorta: A first consensus paper using a Delphi method.

BACKGROUND: To further strengthen the evidence base on the use of Resuscitative Endovascular Balloon occlusion of the Aorta (REBOA) we performed a Delphi consensus. The aim of this paper is to establish consensus on the indications and contraindications for the use of REBOA in trauma and non-trauma patients based on the existing evidence and expertise. STUDY DESIGN: A literature review facilitated the design of a three-round Delphi questionnaire. Delphi panelists were identified by the investigators. Consensus was reached when at least 70% of the panelists responded to the survey and more than 70% of respondents reached agreement or disagreement. RESULTS: Panel members reached consensus on potential indications, contra-indications and settings for use of REBOA (excluding the pre hospital environment), physiological parameters for patient selection and indications for early femoral access. Panel members failed to reach consensus on the use of REBOA in patients in extremis (no pulse, no blood pressure) and the use of REBOA in patients with two major bleeding sites. CONCLUSIONS: Consensus was reached on indications, contra indications, physiological parameters for patient selection for REBOA and early femoral access. The panel did not reach consensus on the use of REBOA in patients in pre-hospital settings, patients in extremis (no pulse, no blood pressure) and in patients with 2 or more major bleeding sites. Further research should focus on the indications of REBOA in pre hospital settings, patients in near cardiac arrest and REBOA inflation times.

Migration of Aortic Occlusion Balloons in an in vitro model of the human circulation.

BACKGROUND: Aortic Occlusion Balloons (AOB) are used for hemorrhage control in hemodynamically unstable patients. Stability of an AOB is essential for reliable aortic occlusion. The primary aim of this study is to determine whether different types of AOB migrate after total, intermittent or partial occlusion in a porcine aorta positioned in an in vitro model. MATERIALS AND METHODS: A porcine thoracic aortic section was positioned in a model of the human circulation. Primary and secondary migration was tested in Cook Coda™ 2-9.0-35-120-32 and 2-10-35-140-46, Cook Medical, USA; Rescue balloon™ Tokai RB-167080-E, Tokai Medical Products, Japan; Reliant™ AB46, Medtronic, USA; Russian prototype AOB; ER-REBOA™, Prytime Medical Devices, USA; LeMaitre™ 28 and 45 Aortic Occlusion Catheter, LeMaitre Vascular, USA. These AOB were tested in hypotensive, normotensive and hypertensive scenarios. Migration in total occlusion, intermittent occlusion and partial occlusion was recorded for all AOB. RESULTS: Limited primary migration occurred in all AOB after total occlusion. The Cook Coda™ 2-9.0-35-120-32 balloon showed maximal migration in 1 test cycle. No migration occurred during intermittent occlusion. Kinking occurs in various degrees but does not seem to prevent a successful occlusion of the aorta. No migration occurred during partial occlusion except in the Russian prototype AOB. In a partial occlusion scenario, distal perfusion occurred only with 5 ml remaining in all balloon types. CONCLUSIONS: All AOB were successful in full aortic occlusion. Limited primary migration occurred in all AOB after total occlusion only the Cook Coda™ 2-9.0-35-120-32 balloon showed maximal migration once. No migration occurred during intermittent occlusion, during partial occlusion only the Russian prototype AOB migrated. Stiffness and size of the catheter are important factors in preventing migration and kinking.

A systematic review and meta-analysis of the use of resuscitative endovascular balloon occlusion of the aorta in the management of major exsanguination.

BACKGROUND: Circulatory collapse is a leading cause of mortality among traumatic major exsanguination and in ruptured aortic aneurysm patients. Approximately 40% of patients die before hemorrhage control is achieved. Resuscitative endovascular balloon occlusion of the aorta (REBOA) is an adjunct designed to sustain the circulation until definitive surgical or endovascular repair. A systematic review was conducted for the current clinical use of REBOA in patients with hemodynamic instability and to discuss its potential role in improving prehospital and in-hospital outcome. METHODS: Systematic review and meta-analysis (1900-2017) using MEDLINE, Cochrane, EMBASE, Web of Science and Central and Emcare using the keywords "aortic balloon occlusion", "aortic balloon tamponade", "REBOA", and "Resuscitative Endovascular Balloon Occlusion" in combination with hemorrhage control, hemorrhage, resuscitation, shock, ruptured abdominal or thoracic aorta, endovascular repair, and open repair. Original published studies on human subjects were considered. RESULTS: A total of 490 studies were identified; 89 met criteria for inclusion. Of the 1436 patients, overall reported mortality was 49.2% (613/1246) with significant differences (p < 0.001) between clinical indications. Hemodynamic shock was evident in 79.3%, values between clinical indications showed significant difference (p < 0.001). REBOA was favored as treatment in trauma patients in terms of mortality. Pooled analysis demonstrated an increase in mean systolic pressure by almost 50 mmHg following REBOA use. CONCLUSION: REBOA has been used in trauma patients and ruptured aortic aneurysm patients with improvement of hemodynamic parameters and outcomes for several decades. Formal, prospective study is warranted to clarify the role of this adjunct in all hemodynamic unstable patients.

A Peculiar Case of a Floating Angio-Seal.

PURPOSE: To show a complication of the use of an Angio-Seal™ closure device. CASE: We present a patient with a systolic murmur in his femoral artery after PCI. The murmur was caused by a dislocated Angio-Seal™, a vascular closure device. This was diagnosed by Doppler Ultrasound. The device was surgically removed. CONCLUSION: Vascular complications, such as lower limb ischemia, requiring surgical intervention tend to be higher after use of a vascular closure device. We advise routine physical examination of the puncture site after percutaneous closure with a vascular closure device, such as an Angio-Seal™. The removal of the device can be performed via an open or endoscopic approach, based on available experience.

Necrotising fasciitis due to an infected sebaceous cyst.

The current case presents a patient who was admitted to our hospital with the diagnosis of cellulitis of the right groin. In the following days, the patient's condition deteriorated and developed a septic shock. Exploration in the operating room showed a necrotising fasciitis of the adductor muscles, with an infected sebaceous cyst in the inguinal crest as port d'entrée. After extensive surgical debridement, antibiotic therapy, haemodynamic and respiratory support, the patient recovered. Necrotising fasciitis is a rare but very lethal condition, which necessitates aggressive surgical therapy and antibiotic support. The current case report is the first report to show a necrotising fasciitis due to an infected sebaceous cyst.

Infections of intravascular bare metal stents: a case report and review of literature.

OBJECTIVE: The objective of the paper is to present a case of an infected bare metal stent in the left common iliac artery that was removed by an urgent operation, and to review the literature on diagnosis and outcome of infected coronary and non-coronary metal stents. METHODS: A systematic search of the Medline database was performed with the purpose of identifying risk factors, signs and symptoms, imaging strategies, and treatment modalities of bare metal stent infections, both coronary and peripheral. RESULTS: In total, 76 additional studies/case reports (48 non-coronary; 29 coronary) were included and analyzed. Intravascular bare metal stent infections are a rare but serious complication, often leading to emergency surgery (overall: 75.3%; non-coronary cases: 83.3%; coronary cases: 62.1%). In 25.0% of the non-coronary cases, infection led to amputation of an extremity or removal of viscera. Reported mortality was up to 32.5% of the cases (non-coronary: 22.9%; coronary 48.3%). Physicians should always be suspicious of a stent infection when patients present with aspecific symptoms such as fever and chills after stent placement. Additional imaging can be used to detect the presence of a pseudoaneurysm. A PET-CT is an ideal medium for identification of a stent infection. CONCLUSIONS: Intravascular stent infection is associated with a high risk of morbidity and mortality. Surgery is the preferred treatment option, but not always possible, especially in patients with a coronary stent. In selected cases, bare metal stent infections may be prevented by the use of prophylactic antibiotics at stent placement.

Pain perception during and after VNUS ClosureFAST™ procedure.

The objective of the study was first to quantify the level of pain that patients experience during VNUS ClosureFAST™ and in the first week following treatment. Secondly, to investigate the use of pain medication. Thirdly, to identify after how many days patients return to daily activities and whether pain is a factor of influence. A prospective descriptive cohort study was carried out. In all, 104 consecutive VNUS ClosureFAST procedures for greater saphenous vein (GSV) incompetence between 18 May and 28 August 2009 in the HagaZiekenhuis were included. A visual analogue score (VAS) was recorded immediately after the procedure. These patients were asked to register pain scores during the week following the procedure, the amount of pain medication if used and the time elapsed between the procedures and resuming daily activities. The average VAS score during the VNUS Closure procedure was four. The first three days after the procedure the VAS score was 2. After four days, the average score was 1. The average return to daily activities was on day two after the procedure. In total, 24% of all patients used paracetamol after the procedure. In summary, VNUS ClosureFAST procedure for GSV incompetence is not a painless treatment. After an average of two days, patients return to their daily activities. Pain does not seem to be a major factor in the resumption. Seventy-six percent of patients do not use any pain medication.

Effects of short-term treatment with metformin on serum concentrations of homocysteine, folate and vitamin B12 in type 2 diabetes mellitus: a randomized, placebo-controlled trial.

OBJECTIVE: Metformin is a key treatment option in type 2 diabetes. However, metformin may decrease vitamin B12 levels and increase levels of homocysteine, a cardiovascular risk factor. We investigated whether 16 weeks of treatment with metformin affects serum concentrations of homocysteine, folate and vitamin B12 in subjects with type 2 diabetes treated with insulin. DESIGN: Placebo-controlled, randomized trial. MEASUREMENTS: at baseline and 16 weeks later. SETTING: This trial was conducted in the outpatient clinics of three general hospitals in The Netherlands. SUBJECTS: A total of 745 patients with type 2 diabetes, treated with insulin and not known with a contraindication for the use of metformin, were approached; 390 gave informed consent and entered the study. Thirty-seven subjects dropped out (12 placebo and 25 metformin users). INTERVENTION: Addition of metformin or placebo to insulin therapy. PRIMARY OUTCOME PARAMETERS: Serum homocysteine, folate, vitamin B12, indices of glycaemic control and body weight. RESULTS: Amongst those who completed 16 weeks of treatment, metformin use, as compared with placebo, was associated with an increase in homocysteine of 4% (0.2 to 8; P=0.039) and with decreases in folate [-7% (-1.4 to -13); P=0.024] and vitamin B12 [-14% (-4.2 to -24); P<0.0001]. In addition, the increase in homocysteine could be explained by the decreases in folate and vitamin B12. CONCLUSION: In patients with type 2 diabetes, 16 weeks of treatment with metformin reduces levels of folate and vitamin B12, which results in a modest increase in homocysteine. The clinical significance of these findings remains to be investigated.

Discontinuation of metformin in type 2 diabetes patients treated with insulin.

BACKGROUND: Metformin added to insulin therapy in type 2 diabetic patients improves glycaemic control and decreases the required daily dose of insulin (DDI). Metformin should be discontinued if cardiac, hepatic or renal failure develops. We examined whether glycaemic control can be maintained after metformin cessation. METHODS: We included 45 type 2 diabetic patients treated with insulin plus metformin, and 45 matched controls treated with insulin only. After discontinuation of metformin in the first group, we aimed for tight fasting and postprandial blood glucose levels, 4-7 and 4-10 mmol/l, respectively, in both groups. During 12 weeks we assessed glycaemic control every two weeks and, if necessary, adjusted the insulin dosage. RESULTS: In the group in which metformin was discontinued, DDI increased from 67.9 +/- 22.9 to 92.2 +/- 29.4 IU (p < 0.001) leaving glycaemic control unchanged. In the controls, glycated haemoglobin (GHb) decreased by 0.93% (p < 0.001), while DDI increased slightly from 62.4 +/- 22.9 to 72.3 +/- 27.3 IU (p < 0.001). The increase in DDI was larger in patients in whom metformin was discontinued than in the controls (p < 0.001). CONCLUSIONS: In type 2 diabetic patients treated with insulin plus metformin, glycaemic control can be maintained after discontinuation of metformin by increasing the DDI substantially (20 to 36%) during application of an intensified treatment protocol.

Expression of co-stimulatory and adhesion molecules and chemokine or apoptosis receptors on acute myeloid leukaemia: high CD40 and CD11a expression correlates with poor prognosis.

The expression of adhesion and co-stimulatory molecules, and chemokine and death receptors such as tumour necrosis factor (TNF) and FAS on acute myeloid leukaemia (AML) may influence the biology of the disease and response to chemotherapy and immunotherapy. In this study, we analysed the expression of these molecules in 99 AML patients using monoclonal antibodies and flow cytometry, and correlated the expression with French-American-British (FAB) classification and survival. The following molecules were studied: the co-stimulatory molecules CD80, CD86 and CD40; the adhesion molecules CD11a-c, CD31, CD43, CD50, CD54, CD102, CD58 and CD62L; the chemokine receptor CXCR4; and the death receptors TNFR1 and TNFR2 and FAS. The expression of all molecules was significantly higher in the M4/M5 FAB subgroups except for CD80, CD43, CD54 and CD62L. The AML M3 subgroup had a significant lower expression of CD11a (P = 0.02) and CD11c (P = 0.03). Five-year survival was significantly shorter in cases of high CD40 expression [> 20% positive cells, relative risk (RR) 2.56, P = 0.02] or high CD11a expression (> 80% positive cells, RR 2.6, P = 0.03). This effect was most prominently present in the AML M4/M5 FAB subgroups. We conclude that the expression levels of adhesion and co-stimulatory molecules, CXCR4 and apoptosis-receptors are predominantly FAB subtype-related with high CD40 and CD11a expression as poor prognostic factors.