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Subacute and chronic subdural hematomas are common and frequently recur after surgical evacuation. The effect of adjunctive middle meningeal artery embolization on the risk of reoperation remains unclear.

In a prospective, multicenter, interventional, adaptive-design trial, we randomly assigned patients with symptomatic subacute or chronic subdural hematoma with an indication for surgical evacuation to undergo middle meningeal artery embolization plus surgery (treatment group) or surgery alone (control group). The primary end point was hematoma recurrence or progression that led to repeat surgery within 90 days after the index treatment. The clinical secondary end point was deterioration of neurologic function at 90 days, which was assessed with the modified Rankin scale in a noninferiority analysis (margin for risk difference, 15 percentage points).

A total of 197 patients were randomly assigned to the treatment group and 203 to the control group. Surgery occurred before randomization in 136 of 400 patients (34.0%). Hematoma recurrence or progression leading to repeat surgery occurred in 8 patients (4.1%) in the treatment group, as compared with 23 patients (11.3%) in the control group (relative risk, 0.36; 95% confidence interval [CI], 0.11 to 0.80; P = 0.008). Functional deterioration occurred in 11.9% of the patients in the treatment group and in 9.8% of those in the control group (risk difference, 2.1 percentage points; 95% CI, -4.8 to 8.9). Mortality at 90 days was 5.1% in the treatment group and 3.0% in the control group. By 30 days, serious adverse events related to the embolization procedure had occurred in 4 patients (2.0%) in the treatment group, including disabling stroke in 2 patients; no additional events had occurred by 180 days.

Among patients with symptomatic subacute or chronic subdural hematoma with an indication for surgical evacuation, middle meningeal artery embolization plus surgery was associated with a lower risk of hematoma recurrence or progression leading to reoperation than surgery alone. Further study is needed to evaluate the safety of middle meningeal artery embolization in the management of subdural hematoma. (Funded by Medtronic; EMBOLISE ClinicalTrials.gov number, NCT04402632.).

Bloodstream infections are associated with substantial morbidity and mortality. Early, appropriate antibiotic therapy is important, but the duration of treatment is uncertain.

In a multicenter, noninferiority trial, we randomly assigned hospitalized patients (including patients in the intensive care unit [ICU]) who had bloodstream infection to receive antibiotic treatment for 7 days or 14 days. Antibiotic selection, dosing, and route were at the discretion of the treating team. We excluded patients with severe immunosuppression, foci requiring prolonged treatment, single cultures with possible contaminants, or cultures yielding Staphylococcus aureus. The primary outcome was death from any cause by 90 days after diagnosis of the bloodstream infection, with a noninferiority margin of 4 percentage points.

Across 74 hospitals in seven countries, 3608 patients underwent randomization and were included in the intention-to-treat analysis; 1814 patients were assigned to 7 days of antibiotic treatment, and 1794 to 14 days. At enrollment, 55.0% of patients were in the ICU and 45.0% were on hospital wards. Infections were acquired in the community (75.4%), hospital wards (13.4%) and ICUs (11.2%). Bacteremia most commonly originated from the urinary tract (42.2%), abdomen (18.8%), lung (13.0%), vascular catheters (6.3%), and skin or soft tissue (5.2%). By 90 days, 261 patients (14.5%) receiving antibiotics for 7 days had died and 286 patients (16.1%) receiving antibiotics for 14 days had died (difference, -1.6 percentage points [95.7% confidence interval {CI}, -4.0 to 0.8]), which showed the noninferiority of the shorter treatment duration. Patients were treated for longer than the assigned duration in 23.1% of the patients in the 7-day group and in 10.7% of the patients in the 14-day group. A per-protocol analysis also showed noninferiority (difference, -2.0 percentage points [95% CI, -4.5 to 0.6]). These findings were generally consistent across secondary clinical outcomes and across prespecified subgroups defined according to patient, pathogen, and syndrome characteristics.

Among hospitalized patients with bloodstream infection, antibiotic treatment for 7 days was noninferior to treatment for 14 days. (Funded by the Canadian Institutes of Health Research and others; BALANCE ClinicalTrials.gov number, NCT03005145.).

Peripheral veno-arterial extracorporeal membrane oxygenation (ECMO) is a powerful life-saving tool; however, it can sometimes induce severe pulmonary edema in patients with critical heart failure. We report favorable outcomes in critically ill patients by using a central ECMO system with an innovative blood perfusion method.

We analyzed 10 patients with severe heart failure and pulmonary edema who were treated with the central ECMO system at our institution between April 2022 and October 2023. The system consists of central cannulation with two inflows from the right atrium and left ventricle, and two outflows to the aorta and pulmonary artery, connected by two Y-connectors to a single ECMO circuit (RALV-AOPA ECMO). In this system, blood flow to the pulmonary artery is adjusted and mean pulmonary artery pressure is limited to <20 mm Hg, which reduces right ventricular afterload and prevents the worsening of pulmonary edema and hemorrhage.

Six patients were diagnosed with fulminant lymphocytic myocarditis, and four were diagnosed with coronavirus disease 2019-related myocardial injury. The ejection fraction was 6.5 ± 4.1%. The average intraoperative pulmonary vascular resistance was 4.6 ± 1.3 Wood units. After 24 h, the mean pulmonary arterial pressure was 12.8 ± 4.3 mm Hg, and pulmonary vascular resistance was 1.5 ± 0.3 Wood units. The duration of central RALV-AOPA ECMO was 3.7 ± 2.1 days. Finally, six patients were weaned, three received HeartMate3, and one received heart transplantation. At follow-up, all patients remained alive (428 ± 208 days), and two patients experienced cerebrovascular accidents without any lasting sequelae.

The central RALV-AOPA ECMO is an innovative system that achieves early improvement in pulmonary vascular resistance and is safe and feasible for patients with acute biventricular failure and pulmonary edema.

The cost and complexity associated with animal testing are significantly reduced by using mock circulatory loops prior. Novel mock circulatory loops allow us to test biomedical devices preclinically due to their flexibility, scalability, and cost-effectiveness. The presented work describes the development of a hardware-in-the-loop platform to emulate human physiology for the Istanbul Heart (iHeart-II) LVAD.

A closed-loop system is developed whereby the effect of the LVAD on the heart and vice versa can be studied. An acausal model of the cardiovascular system is calibrated to emulate advanced-stage heart failure. A new prototype of the iHeart-II LVAD is connected between two air-actuated chambers emulating the left ventricle and aortic chambers with PID controllers tracking numerically modeled pressures from the in silico model. A lead-lag compensator is used to maintain fluid level. Controllers are tuned using nonlinear Hammerstein-Weiner models identified using open-loop data. The iHeart-II LVAD is operated at various speeds in its operational range, and the resulting hemodynamics are visualized in real time.

Hemodynamic variables, such as LVAD flow rate, aortic, left ventricular, and pulse pressure, demonstrate trends similar to clinical observations. The iHeart-II LVAD achieves hemodynamic normalization at ~3500 rpm for the emulated condition.

A novel evaluation methodology is adopted to study the performance of the iHeart LVAD under advanced-stage heart failure emulation. The models and controllers used in the platform are readily replicable to facilitate VAD research, pedagogy, design, and development.