Persons with disorders of consciousness (DoC) occupy an ethically charged space in modern medicine and biomedical research. Their decisional capacity is characteristically absent or limited or unpredictably fluctuates, requiring clinicians and investigators to rely on surrogates. Although there is general guidance for informed consent (IC) for research studies, there is no specific guidance for research involving persons with DoC. There are inconsistencies in IC forms for these studies related to explanation of a DoC, evaluation of capacity, description of risks/benefits, and sharing investigational results. This is problematic for persons with DoC, their surrogates, researchers, and institutional review boards (IRBs)/research ethics boards (REBs). To address these issues, the Curing Coma Campaign (CCC) Ethics Workgroup developed the Common Consent Elements for Research Involving Persons with Disorders of Consciousness (CCE-DoC). This practical framework aims to clarify and standardize consent processes in this complex and ethically sensitive research area. Through this structured, adaptable approach, CCE-DoC may have the potential to enhance participant protections, strengthen trust, help families and decision-makers understand studies, reduce duplicative efforts across research groups, and guide investigators and IRBs/REBs in navigating the complex ethical terrain of consent in DoC research. In so doing, CCE-DoC seeks to extend respect for autonomy and trust and promote responsible research urgently needed to advance paradigms of diagnosis, prognosis, and treatment for individuals with disorders of consciousness. The framework offers example language to encourage standardization, while allowing teams flexibility to customize to local needs.
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BACKGROUND AND AIMS:The TRISCEND II trial demonstrated superior clinical benefits for patients with ≥severe tricuspid regurgitation (TR) treated with the EVOQUE transcatheter tricuspid valve replacement (TTVR) system plus medical therapy vs medical therapy alone. This work reports 1-year and 18-month outcomes in patients stratified by baseline TR severity. METHODS:The multicentre, prospective TRISCEND II trial enrolled 400 patients with symptomatic, ≥severe TR, and randomized 2:1 to TTVR (n = 267) or control (n = 133). In a post hoc analysis, patients were stratified into severe TR (n = 172) and massive/torrential TR (n = 220) cohorts. Clinical and quality-of-life outcomes were reported at 1 year, with Kaplan-Meier estimates for all-cause mortality and heart failure (HF) hospitalization assessed at 18 months. Study oversight included an independent echocardiographic core laboratory, clinical events committee, and data safety monitoring board. RESULTS:One year after TTVR, TR was ≤mild in 95.2% of severe TR and 95.3% of massive/torrential TR patients. The primary safety and effectiveness endpoint (win ratio) favoured TTVR over control regardless of baseline TR severity: severe {1.64 [95% confidence interval (CI): 1.11, 2.43]} and massive/torrential [2.20 (1.55, 3.14)]. At 18 months, TTVR patients had similar mortality to controls [rate difference: severe 0.2% (-11.6, 11.9), massive/torrential -5.8% (-17.6, 6.0)], whereas HF hospitalization rates favoured TTVR in the massive/torrential cohort [vs control, severe 9.8% (-3.0, 22.7), massive/torrential -15.2% (-28.9, -1.5)]. CONCLUSIONS:Patients with ≥severe TR benefit from TTVR, experiencing improvements in TR severity, functional capacity, and quality of life regardless of baseline TR severity, with a signal for greater benefit in patients with more advanced disease.
BACKGROUND:Large-bore aspiration catheters are integral to mechanical thrombectomy (MT) for large vessel occlusions (LVOs), offering potential for improved first pass success and faster recanalization. OBJECTIVE:To assess the clinical performance, efficacy, and safety profile of the Broadway 8 system as a primary aspiration device in MT of LVOs. METHODS:This is a multicenter observational study conducted across 8 US comprehensive stroke centers. Efficacy outcomes included first pass effect (FPE), defined as a single-pass modified Treatment In Cerebral Infarction (mTICI) score ≥2c, and successful reperfusion (final mTICI ≥2b). Safety outcomes included device-related complications, symptomatic intracranial hemorrhage (sICH), and inpatient mortality. Functional outcomes included modified Rankin Scale (mRS) at discharge and delta National Institutes of Health Stroke Scale (NIHSS) score. Logistic regression was used to assess predictors of thrombus access and intermediate catheter use. RESULTS:49 patients were included. The Broadway 8 system reached the thrombus in 44 (89.8%). Median puncture-to-thrombus and puncture-to-reperfusion times were 11 min (IQR 9-18) and 20 min (14-31), respectively. FPE was achieved in 20 (40.8%). Successful reperfusion was achieved in 46/49 (93.8%), with 35 (71.4%) using Broadway 8. sICH occurred in 2 patients (4.1%). Median mRS at discharge was 3.0 (IQR 1.0-4.0); delta NIHSS was 8 (IQR 5-12). Regression analysis showed faster reperfusion when Broadway 8 was used without an intermediate catheter. CONCLUSION:The Broadway 8 system appears to be a safe and effective frontline aspiration device, demonstrating a safety and efficacy profile comparable to other large-bore aspiration systems that incorporate delivery-assist technology.
