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In this trial involving fetuses with severe left congenital diaphragmatic hernia, fetoscopic endoluminal tracheal occlusion at 27 to 29 weeks of gestation significantly increased survival to discharge, but it resulted in an increased incidence of preterm, prelabor rupture of membranes and preterm birth.

In this randomized trial involving fetuses with moderate left congenital diaphragmatic hernia, fetoscopic endoluminal tracheal occlusion at 30 to 32 weeks of gestation did not significantly increase survival to discharge from a NICU or reduce the need for oxygen supplementation at 6 months, and it increased the risks of preterm, prelabor rupture of membranes and preterm birth. The surgical technique is shown in an animated video.

Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a method to provide temporary control of noncompressible torso hemorrhage in trauma patients. Previous research on REBOA has mainly focused on animals and patients. This study aims to explore whether thigh cuff inflation combined with simulated hemorrhage can serve as an experimental human model for zone 3 REBOA. Lower body negative pressure is a model of hypovolemia. A zone 3 REBOA occludes aorta at its bifurcation, essentially excluding the pelvis and lower extremities from the circulation. Bilateral proximal thigh cuffs will occlude blood vessels to and from the lower extremities. Twenty healthy volunteers will be exposed to bilateral proximal thigh cuff inflation to suprasystolic pressures to simulate the hemodynamic effects of REBOA during experimental hemorrhage using lower body negative pressure (LBNP). Each participant will complete two experimental conditions in a randomized order within one study visit. In the one condition, subjects will undergo only 60 mmHg LBNP for six minutes. In the alternate condition, 60 mmHg LBNP will be applied for six minutes, adding thigh cuff inflation during the final three minutes. Continuous, non-invasive monitoring of systemic hemodynamic parameters—including arterial blood pressure, stroke volume, and heart rate—will be conducted. Cerebral hemodynamics will be assessed by measuring middle cerebral artery blood velocity and cerebral oxygenation. Pain related to thigh cuff inflation will be assessed using a verbal numerical rating scale. The impact of thigh cuff inflation on systemic and cerebral hemodynamics will be evaluated using mixed-effects regression modeling. This study aims to examine the systemic and cerebral hemodynamic effects of combined thigh cuff inflation and lower body negative pressure in healthy volunteers. Based on the feasibility and findings, the potential of this combination as a model for zone 3 REBOA in simulated hemorrhage will be discussed.

The Clinical Efficacy of Permanent Internal Mammary Artery Occlusion in Chronic Coronary Syndrome (CLIMACCS) trial, a randomized, sham-controlled trial, tested the clinical efficacy of permanent internal mammary artery (IMA) device occlusion on symptoms in patients with chronic coronary syndrome (CCS), coronary artery occlusive blood supply, and myocardial ischemia. This was a prospective trial in 101 patients with CCS randomly allocated (1:1) to IMA device occlusion (verum group) or to IMA sham intervention (placebo group). The primary study end point was the change in treadmill exercise time (ET) (ΔET in seconds) at 6 weeks after trial intervention. Secondary study end points were the changes in collateral flow index (CFI) and angina pectoris during a simultaneous 1-minute proximal balloon occlusion of a coronary artery. CFI is the ratio between simultaneous mean coronary occlusive, divided by mean aortic pressure, both subtracted by central venous pressure. In the verum and placebo groups, the ET changed from 398 ± 176 seconds to 421 ± 198s in the verum group (p = 0.1745) and from 426 ± 162 seconds to 430 ± 166 seconds in the placebo group (p = 0.55); ΔET amounted to +23 ± 116s and +4 ± 120 seconds, respectively (p = 0.44). CFI change during follow-up equaled +0.022 ± 0.061 in the verum and −0.039 ± 0.072 in the placebo group (p <0.0001). Angina pectoris at follow-up during the coronary balloon occlusion for CFI measurement had decreased or disappeared in 20 of 48 patients in the verum group and in 9 of 47 patients in the placebo group (p = 0.0242). In conclusion, permanent IMA device occlusion tends to augment treadmill ET in response to increased coronary artery occlusive blood supply, which is reflected by mitigated symptoms and signs of myocardial ischemia.

Background and aims Spontaneous-portosystemic-shunts (SPSS) in cirrhosis deprive the liver of nutrient-rich portal blood and contribute to recurrent hepatic encephalopathy (HE). We evaluated the effects of shunt occlusion and redirecting portal blood to liver on its volume and functions. Methods Cirrhosis patients presenting with recurrent HE and having SPSS were randomized to receive standard medical treatment (SMT) or shunt occlusion (SO). The later was performed by plug-assisted or balloon-occluded retrograde transvenous obliteration. The primary endpoint was change in liver volume after a minimum follow-up of 3 months. Secondary objectives included clinical course, liver disease severity indices, arterial ammonia levels and bone density. Results Of 40 enrolled patients, 4 in SMT and 2 in SO group were lost to follow-up. The SO was complete in 17 and partial in one, achieving non-recurrence of HE in 17 (94.4%). In these patients, the mean liver volume increased (baseline 1040 ± 335 ml to 1132 ± 322 ml, 8.8% increase, p  < 0.001) and was observed in 16/18 (88.89%) patients. In the SMT group, the liver volume decreased (baseline 988 ± 270 ml to 904 ± 226 ml, 8.6% reduction, p  = 0.009) during the same period. Serum albumin increased in SO group (2.92 ± 0.40 g/dl to 3.30 ± 0.49 g/dl, p  = 0.006) but reduced in SMT group (2.89 ± 0.43 g/dl to 2.59 ± 0.65 g/dl, p  = 0.047). After SO, the patients showed a reduction in serum-ammonia levels (181.06 ± 86.21 to 107.28 ± 44.53 μ/dl, p  = 0.001) and an improvement in MELD-Na and bone density compared to SMT group. There were no major adverse events following shunt occlusion. Conclusion Occlusion of large SPSS results in improving the volume and synthetic functions of the liver by restoring hepato-petal portal flow besides reducing serum-ammonia level and recurrence of HE. ClinicalTrials.gov number, NCT03293459.

BackgroundComplete occlusion of an intracranial aneurysm (IA) after the deployment of a flow-diverter stent is currently unpredictable. The aim of this study was to develop a predictive occlusion score based on pretreatment clinical and angiographic criteria.MethodsConsecutive patients with ≥6 months follow-up were included from 2008 to 2019 and retrospectively analyzed. Each IA was evaluated using the Raymond–Roy occlusion classification (RROC) and dichotomized as occluded (A) or residual (B/C); 80% of patients were randomly assigned to the training sample. Feature selection and binary outcome prediction relied on logistic regression and threshold maximizing class separation selected by a CART tree algorithm. The feature selection was addressed by a genetic algorithm selected from the 30 pretreatment available variables.ResultsThe study included 146 patients with 154 IAs. Feature selection yielded a combination of six variables with a good cross-validated accuracy on the test sample, a combination we labeled DIANES score (IA diameter, indication, parent artery diameter ratio, neck ratio, side-branch artery, and sex). A score of more than −6 maximized the ability to predict RROC=A with sensitivity of 87% (95% CI 79% to 95%) and specificity of 82% (95% CI 64% to 96%) in the training sample. Accuracy was 86% (95% CI 79% to 94%). In the test sample, sensitivity and specificity were 89% (95% CI 77% to 98%) and 60% (95% CI 33% to 86%), respectively. Accuracy was 81% (95% CI 69% to 91%).ConclusionA score was developed as a grading scale for prediction of the final occlusion status of IAs treated with a flow-diverter stent.

Natural, nonsurgical internal mammary artery (IMA) bypasses to the coronary circulation have been shown to function as extracardiac sources of myocardial blood supply. The goal of this randomized, placebo-controlled, double-blind trial was to test the efficacy of permanent right IMA (RIMA) device occlusion on right coronary artery (RCA) occlusive blood supply and on clinical and electrocardiographic (ECG) signs of myocardial ischemia. This was a prospective superiority trial in 100 patients with chronic coronary artery disease randomly allocated (1:1) to RIMA vascular device occlusion (verum group) or to RIMA sham procedure (placebo group). The primary study end point was RCA collateral flow index (CFI) as obtained during a 1-minute ostial RCA balloon occlusion at baseline before and at follow-up examination 6 weeks after the trial intervention. CFI is the ratio between simultaneous mean coronary occlusive divided by mean aortic pressure both subtracted by central venous pressure. Simultaneously obtained secondary study end points were the registration of angina pectoris and quantitative intracoronary ECG ST-segment shift. CFI change during the follow-up period was +0.036 ± 0.068 in the verum group and −0.021 ± 0.097 in the placebo group (P = .0011). Angina pectoris during the same RCA balloon occlusions had disappeared at follow-up in 14/49 patients of the verum group and in 4/49 patients of the placebo group (P = .0091). Simultaneous intracoronary ECG ST-segment shift change revealed diminished myocardial ischemia at follow-up in the verum group and more severe ischemia in the placebo group. Permanent RIMA device occlusion augments RCA supply to the effect of diminishing clinical and electrocardiographic signs of myocardial ischemia during a brief controlled coronary occlusion. [Display omitted]

Background The placenta accreta spectrum (PAS) is a severe complication of pregnancy and is associated with massive haemorrhage, hysterectomy, and even perinatal maternal-foetal death. Prophylactic abdominal aortic balloon occlusion (PAABO) is a novel and efficient therapy for these patients. The aim of this study was to investigate the benefits, potential risks, and characteristics of anaesthesia management. Methods A total of 48 parturients with PAS were enrolled and divided into two groups. Group A ( n  = 25) received PAABO, and Group B ( n  = 23) underwent a normal operative procedure. The characteristics of the general parameters, anaesthesia, and operative procedure were noted. Data on vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) during the operation were recorded. Before and after the procedure, hepatic and renal function and lactate dehydrogenase (LDH) were also measured. Results The characteristics of the groups were comparable. PAABO significantly reduced estimated blood loss, which was ≥ 1000 ml. Drastic fluctuations in SBP, DBP and HR were observed during inflation and deflation in Group B. After the operation, increased LDH and glutamic oxaloacetic transaminase (GOT) were observed in both groups, and increased glutamic-pyruvic transaminase (GTP) was observed in Group B. Conclusions PAABO reduced perioperative blood loss and the risk of hysterectomy among parturients with PAS. Sophisticated anaesthetic management should be implemented to prevent or reduce perioperative complications and address internal disorders that are caused by massive blood loss.

Purpose To compare the clinical outcomes of balloon-occluded retrograde transvenous obliteration (BRTO) using ethanolamine oleate (EO), BRTO using sodium tetradecyl sulfate (STS) foam, and vascular plug-assisted retrograde transvenous obliteration (PARTO). Materials and Methods From April 2004 to February 2015, ninety-five patients underwent retrograde transvenous obliteration for gastric varices were analyzed retrospectively. BRTO with EO was performed in 49 patients, BRTO with STS foam in 25, and PARTO in 21. Among them, we obtained follow-up data in 70 patients. Recurrence of gastric varices was evaluated by follow-up endoscopy or CT. Medical records were reviewed for the clinical efficacy. Statistical analyses were performed by Kaplan–Meier method, Chi-square, Fisher’s, and Kruskal–Wallis tests. Results Technical and clinical success was 94.7 %. As major complications, a hemoglobinuria and a death due to disseminated intravascular coagulation (DIC) were occurred in two patients with BRTO using EO. Recurrence occurred more frequently in PARTO group ( P  < 0.05). Recurrence occurred in three patients in BRTO using EO group and four patients in PARTO group with 3.2 and 32.8 % of each expected 1-year recurrence rates. There was no recurrence in BRTO using STS group. Abdominal pain occurred more frequently in BRTO using EO than BRTO using STS foam and PARTO ( P  < 0.05). Procedure time of PARTO was shorter than two conventional BRTOs ( P  < 0.05). Conclusions BRTO using STS foam or PARTO is better than BRTO using EO for treatment of gastric varices in terms of complication or procedure time. However, PARTO showed frequent recurrence of gastric varices during the long-term follow-up rather than BRTO.