3-month Outcome Research Articles

Abstract 4113573: Long Noncoding RNAs to Predict COVID-19 Neuro-Cardio-Vascular Outcomes

Introduction/Background: Cardiovascular and neurological diseases develop in a significant proportion of COVID-19 patients. Minimally invasive tools to predict outcome after SARS-CoV-2 infection would enable personalized healthcare, potentially easing the disease burden. We showed that blood levels of the long noncoding RNA lymphoid enhancer-binding factor-1 antisense 1 (LEF1-AS1) predict COVID-19 in-hospital mortality. Hypothesis: LEF1-AS1 is associated with long-term clinical outcomes of COVID-19. Aim: Test the capacity of LEF1-AS1 to predict neuro-cardio-vascular outcomes post-SARS-CoV-2 infection. Methods/Approach: We enrolled 104 primo-infected COVID-19 patients aged 18+ recruited from April to December 2020 in the PrediCOVID national cohort for which 12-month follow-up data were available (Ethics Committee approvals 202003/07 and 202310/02-SU-202003/07). Whole blood samples were collected at baseline and expression levels of LEF1-AS1 were assessed by quantitative PCR. Results/Data: Of the 104 patients, 35 had at least one neurological symptom and one cardiovascular symptom at month 12. Levels of LEF1-AS1 at baseline were lower (p=0.019) in patients who developed neurological and cardiovascular symptoms as compared to patients who did not. Lower LEF1-AS1 was associated with symptoms development with an odds ratio of 0.48 (95% CI 0.28-0.83) from logistic regression model adjusted for age, sex, comorbidities and disease severity at baseline. Addition of LEF1-AS1 to a clinical model including age, sex, comorbidities and baseline severity yielded an incremental predictive value as attested by an increased AUC from 0.79 to 0.83 (likelihood ratio test p=0.005), a net reclassification index of 0.54 (p=0.007) and an integrated discrimination improvement of 0.08 (p=0.009). Conclusion: Blood levels of LEF1-AS1 predict 12-month neurological and cardiovascular outcomes of COVID-19 patients. This needs to be validated in larger populations.

Abstract 4120856: Abdominal Aortic Blood Flow and Interstage Growth and Neurodevelopment in Patients with Single Ventricle Heart Disease

Background: Achieving normal somatic growth and neurodevelopmental (ND) milestones is a common challenge for children with single ventricle heart disease (SV) prior to stage 2 palliation (S2P). This study aimed to characterize the potential association with poor splanchnic and cerebral circulations. Methods: This retrospective single centre study included SV patients born February 1, 2012, to May 30, 2022 who underwent MRI evaluation and S2P <12 months of age. Blood flow indices, including descending aorta flow (DAoNet), were measured by phase-contrast MRI. Primary outcomes were weight-for-age Z score (WFAZ) at S2P, and 18-month ND outcomes measured by Bayley Scales of Infant and Toddler Development 3rd Ed. Spearman’s correlation was used to model associations; statistical significance was considered for p<0.05. Results: A total of 144 patients were included: 61% (n=88) male, 12% (n=17) with genetic anomalies/syndrome, median (interquartile range) gestational age was 38.7 (38, 39.6) weeks, birth weight of 3.2 (2.8-3.6) kg, and birth WFAZ -0.23 (-1.1-0.6). Stage-1 palliation (n=130) was completed at 6 (3-23) days, 34% (n=49) for hypoplastic left heart syndrome, and S2P at 6.1 (5.3-7.1) months with a WFAZ of -1.4 (-2.3- (-0.5)). S2P WFAZ did not correlate with DAoNet (Figure 1), systemic cardiac output, or other blood flow indices. Lower S2P WFAZ was associated with lower birth WFAZ, and perioperative gastrointestinal complications. Lower 18-month motor development score was associated with lower birth WFAZ, native high pulmonary blood flow physiology, and indices of increase pulmonary blood flow: superior vena cava flow (b=8.8; [95% CI: 0.7 to17], p=0.03) and pulmonary venous to systemic blood flow (Qp:Qs) (b=-7, [95% CI: -11.1 to -2.9], p=0.001). Other ND domains were associated with lower birth WFAZ, not blood flow indices. Conclusion: In SV patients, DAoNet did not correlate with growth at S2P. Modifiable factors studied were not associated with somatic growth. DAoNet, superior vena cava flow, and Qp:Qs were associated with 18-months motor development, which may indicate long-term risks of high pulmonary blood flow. Studies are needed to delineate the pathophysiology by which these findings are mediated.

Tunnel Technique and Subepithelial Connective Tissue Graft, With or Without Cross-Linked Hyaluronic Acid, in the Treatment of Multiple Gingival Recessions: Prognostic Parameters for Clinical Treatment Outcomes of Randomized Controlled Trial

Objectives: This study aimed to investigate factors that influence the 12-month outcomes after the treatment of multiple gingival recessions (GRs) with a modified coronally advanced tunnel (MCAT) and a subepithelial connective tissue graft (SCTG), with cross-linked hyaluronic acid (HA, tests) or without (controls). Materials and Methods: Twenty-four patients with 266 GRs were treated. A logistic regression model was set to identify the baseline parameters that could predict the 12-month outcomes. The study protocol was registered at ClinicalTrials.gov (ID No. NCT05045586). Results: The evaluated clinical and esthetic parameters showed marked improvement in both groups without any statistically significant differences between the groups, with the exception of the soft tissue texture (STT). The STT was in favor of the HA group (0.96 versus 0.73, p = 0.0091). The likelihood of an MRC > 85%, of achieving CRC, and of gaining an RES = 10 was the highest for the incisors (reference group) and the lowest for the molars (OR = 0.046, p = 0.005). With each 1 mm increase in the baseline clinical attachment level, the odds of failure (MRC < 85%, not achieving CRC) increased, whereas each 1 mm increase in the baseline keratinized tissue width (KTW) improved the chances of an MRC > 85%, of achieving CRC, and of gaining an RES = 10. The application of HA increased the likelihood of a perfect RES more than twofold (OR = 2.683, p = 0.001). Conclusions: The application of HA improved the 12-month esthetic outcomes after the treatment of GRs with the MCAT technique. The baseline CAL, KTW, and tooth type predicted the 12-month MRC, CRC, and RES. An evaluation of the baseline characteristics of the surgical area might help clinicians develop individualized treatment plans.

Outcome of Coronary Edge In-stent Restenosis Management by Restenting Versus Drug-Eluting Balloon

Abstract Background: The optimal therapeutic strategy for coronary intervention in edge in-stent restenosis (edge ISR) remains less well-defined. Aim: The aim of this study was to assess 12-month outcomes of re-stenting using drug-eluting stents (DESs) versus using drug-eluting balloon (DEB) for managing coronary edge ISR. Patients and Methods: One hundred and four patients with edge ISR were randomly assigned to either DES or DEB. The primary endpoint was stent failure at 12-month follow-up. Results: Significantly lower target vessel revascularization among the DEB group compared to restenting group, (7.7% vs. 23.1%, P = 0.04). Likewise, target vessel-related myocardial infarction rate was significantly lower among the DEB group than restenting (5.7% vs. 23.1%, P = 0.04). On the other hand, there were no significant differences in the rates of deaths or restenosis between the two groups. Conclusion: The DEB is superior to the DES with better both safety and efficacy.

Real-World Performance of Excimer Laser Ablation Combined with Drug-Coated Balloon Versus Drug-Coated Balloon for the Treatment of Femoropopliteal In-Stent Restenosis Disease.

This study aims to assess the effectiveness and identify the risk factors associated with postoperative restenosis in patients with femoropopliteal in-stent restenosis (FP-ISR) disease treated with excimer laser ablation (ELA) combined with drug-coated balloon (DCB) versus DCB alone. This retrospective real-world study compares patients with FP-ISR treated with ELA + DCB versus DCB alone. Additionally, subgroup analysis was conducted for long-segment lesions (lesion length ≥200 mm) and Tosaka III lesions. Then Cox regression analysis was used to examine 24-month outcomes of target lesion revascularization and restenosis. We found no significant differences in primary patency and freedom from clinically driven target lesion revascularization (CD-TLR) at 24 months between the ELA + DCB group (49 patients) and the DCB group (82 patients). In the subgroup analysis of long-segment lesions (target lesion length ≥200 mm), the results showed that ELA + DCB was superior to DCB at 24 months in terms of both primary patency (55.0% vs 35.3%; P = 0.048) and freedom from CD-TLR (77.8% vs 50.8%; P = 0.033). The 2 treatment methods did not show statistical significance in the subgroup analysis of Tosaka III patients. Target lesion length of ≥200 mm was found to have a significant association with restenosis (hazard ratio = 5.28; 95% CI, 2.48-11.23; P < 0.001) and freedom from CD-TLR (hazard ratio = 3.02; 95% CI, 1.02-9.30; P = 0.044) in the multivariate analysis. We do not have sufficient evidence to show a significant difference between ELA + DCB and DCB alone for FP-ISR. However, for patients with long-segment FP-ISR lesions, ELA + DCB may provide better long-term patency. Our results suggest that for patients with long-segment (≥200 mm) FP-ISR, the efficacy of ELA combined with DCB may be superior to that of DCB alone. For patients with FP-ISR <200 mm, DCB alone may achieve satisfactory efficacy, thus reducing the medical burden on patients and allowing for the selection of more appropriate treatment options for different types of lesions.

Validating the Brain Injury Guidelines in a Pediatric Population with Mild Traumatic Brain Injury and Intracranial Injury at a Level I Trauma Center.

Children with mild traumatic brain injury (mTBI) and intracranial injury (ICI) often receive unnecessary imaging and hospital admission, leading to avoidable burdens on patients and health systems. While most of these patients do not develop critical neurological injuries, identifying those at risk would allow for a more optimal determination of the appropriate level of initial emergency care. The Brain Injury Guidelines (BIG) were developed as a triage tool to identify adult patients with mTBI and ICI who can benefit from repeat imaging, hospital admission, or neurosurgical consultation. Here, we sought to validate BIG in children at a Level I trauma center and determine if the BIG algorithm can accurately identify which patients with mTBI/ICI have critical neurosurgical injuries. We hypothesize that the BIG can identify critical neurological injuries more accurately than the Glasgow Coma Scale (GCS) alone and that more severe injury according to BIG is associated with worse patient outcome. We retrospectively reviewed TBI admissions at a single center (2017-2023) using an institutional registry. Patients included (0-17 years) had an initial head computerized tomography scan with ICI and a GCS of 14-15. Patients were retrospectively classified into the BIG categories (BIG 1, 2, or 3). Medical records were reviewed to identify clinically important TBI (ciTBI): death, neurological deterioration, neurosurgical intervention, intubation >24 h, or hospital admission >48 h due to TBI. Repeat imaging studies obtained were evaluated for progression of injury. The incidence of clinically important TBI (ciTBI) and imaging progression were recorded and compared across BIG categories. Outcomes were evaluated using the Glasgow Outcome Score Extended (GOS-E) 6 months after injury. Univariable and chi-square tests were used to analyze comparisons. Overall, 804 subjects were included in the analysis of which 551 (68.5%) were transfers. Overall, 175 (21.8%) patients had a BIG 1, 402 (50.0%) a BIG 2, and 227 (28.2%) a BIG 3 injury. CiTBI occurred among 64 (8.0%) patients overall, and in 1 (0.6%), 4 (1.0%), and 59 (26.0%) of the BIG 1, 2, and 3 injuries (p < 0.0001). Progression on repeat imaging associated with neurological decline, neurosurgical intervention or resulting in additional evaluation was noted in 0 (0%), 2 (0.5%), and 41 (18.0%) of the BIG 1, 2, and 3 injuries (p < 0.001). Amongst 471 patients (58.6%) with available 6-month patient outcomes, 98% had a GOS-E ≥5 and no outcome difference between BIG categories was observed. Risk stratification of mild TBI using BIG allowed for reasonable identification of children who subsequently develop ciTBI, suggesting that BIG classification can aid in triage and management of patients who might benefit from neurosurgical consultation, repeat imaging, and potentially transfer to a dedicated trauma center. More severe injury according to BIG was not associated with a worse patient outcome.

Health related outcomes of patients with serious traumatic injury: Results of a longitudinal follow-up program delivered by trauma clinicians

IntroductionThe routine collection of long-term patient health outcomes after serious traumatic injury at the health service level is uncommon. In 2019, we implemented the longitudinal Trauma Service Follow Up (TSFU) program at a level I trauma centre. Delivered by the trauma service clinicians involved in inpatient care, it assesses quality of life and disability. This study reports the 6- and 12-month outcomes of the first two years of operation of the TSFU program. MethodsThis is a prospective cohort study of seriously injured adult trauma patients admitted to a level I trauma centre with 6- and 12-months post-discharge outcome assessments. Outcomes were quality of life and function/disability as measured using the EQ-5D-5L and WHODAS 2.0 validated instruments. Changes from 6 to 12 months were assessed using generalised estimating equations methods. Logistic regression models were used to identify factors associated with ongoing problems at each time point. ResultsFive-hundred and eight seriously injured patients were eligible for the TSFU program with follow-up rates over 80 % at both 6- and 12-month timepoints. At six months, ongoing problems with pain (69.9 %), anxiety and depression (49 %) and carrying out usual activities (57.5 %) were highly prevalent; at 12 months problems with pain (61.4 %) and anxiety and depression (43.8 %) persisted. Lower extremity and/or pelvic surgery was associated with ongoing pain, odds ratio (OR) = 3.77 (95 % CI 1.54–9.21, p=0.01), anxiety and depression (OR 1.95, 95 % CI 1.09–3.48, p=0.02) and problems carrying out their usual activities (OR 3.19, 95 % CI 0.75–13.5, p=0.11) at six months. These patterns mostly persisted at 12 months. Similar associations between surgical intervention and high levels of disability were evident at both time points. ConclusionPersistent impairments in physical and emotional health continues to affect many people following serious traumatic injury. The collection of longitudinal health outcomes by trauma clinicians enables identification of factors that contribute to disability and a reduction in quality of life. This in turn can drive quality improvement initiatives within the hospital trauma system. Longitudinal follow-up programs may provide a platform to provide ongoing specialist trauma-informed care after hospital discharge.

Relative Benefit of Dual Versus Single Antiplatelet Therapy Among Patients With Atrial Fibrillation on Oral Anticoagulation According to Time After ACS and PCI: Insights From the AUGUSTUS Trial.

In the AUGUSTUS trial (An Open-Label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs Vitamin K Antagonist and Aspirin vs Aspirin Placebo in Patients With Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention), the combination of dual antiplatelet therapy plus oral anticoagulation increased the risk of bleeding without reducing ischemic events compared with a P2Y12 inhibitor plus oral anticoagulation among patients with atrial fibrillation and acute coronary syndrome or elective percutaneous coronary intervention. However, AUGUSTUS enrolled patients up to 14 days after acute coronary syndrome or percutaneous coronary intervention, and there may be a benefit to dual antiplatelet therapy plus oral anticoagulation early after an ischemic event. In this secondary analysis of AUGUSTUS, we divided patients into groups based on whether they were enrolled <6 days (early) or ≥6 days (later) after their index acute coronary syndrome or percutaneous coronary intervention, and tested the interaction between time from the index event to enrollment and randomized treatment (apixaban versus vitamin K antagonist and aspirin versus placebo) on 30-day and 6-month clinical outcomes using Cox proportional hazards models. Among 4605 patients enrolled in AUGUSTUS with data available on time from the index event to enrollment, the median time from the index event to enrollment was 6 (range, 0-14) days. There were no significant interactions between time from the index event and aspirin versus placebo on clinical outcomes at 30 days or 6 months, though patients with time from the index event <6 days had a nominally significant reduction in death or ischemic events at 30 days with aspirin (hazard ratio, 0.55 [95% CI, 0.30-0.99]), whereas patients with time from the index event ≥6 days did not (hazard ratio, 0.88 [95% CI, 0.54-1.43]; interaction P=0.23). There were no significant interactions between time from the index event and apixaban versus vitamin K antagonist on clinical outcomes. Among patients with atrial fibrillation with acute coronary syndrome or undergoing percutaneous coronary intervention, there was no difference in the relative benefit of apixaban versus vitamin K antagonist or aspirin versus placebo when patients were enrolled early versus later after their index event. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02415400.

Long-Term Clinical Outcomes of Drug-Coated Balloon Following Directional Coronary Atherectomy for Bifurcated or Ostial Lesions in the DCA/DCB Registry.

The long-term efficacy of drug-coated balloon (DCB) angioplasty for large bifurcation lesions, particularly those involving the left main trunk (LMT), remains unclear. This study aimed to evaluate the long-term outcomes of directional coronary atherectomy followed by DCB (DCA/DCB) for large bifurcation lesions. This retrospective multicenter study analyzed 129 cases from the DCA/DCB registry, with 80.4% involving LMT bifurcation lesions. Building on previously reported 12-month outcomes, this study assessed long-term results. The primary endpoint was clinically driven (CD) target lesion revascularization (TLR) at 36 months. Secondary endpoints included CD target vessel revascularization (TVR); CD target vessel failure (TVF); and adverse events, such as all-cause mortality, cardiac death, target vessel acute myocardial infarction (AMI), and the need for coronary artery bypass grafting (CABG), at 24 and 36 months. The mean follow-up was 53.4 ± 23.9 months. The CD-TLR rate was 5.0% at 24 months, and the primary endpoint was 5.9% at 36 months. CD-TVR rates were 14.0% at 24 months and 15.0% at 36 months, while CD-TVF rates were 14.9% at 24 months and 16.7% at 36 months. Adverse events included all-cause mortality rates of 0.8% at 24 months and 1.8% at 36 months, and cardiac death rates of 0.8% at both 24 and 36 months. No target vessel AMI or CABG procedures were reported. The consistently low CD-TLR rate at 36 months supports the efficacy of the DCA/DCB strategy for large bifurcation lesions, including LMT, indicating its sustained effectiveness. These findings highlight the viability of this treatment approach.

12206 The Minitouch 3.8 Era Office Endometrial Ablation Procedure: 36-Month Outcomes from a Prospective, Multicenter, Pivotal Clinical Trial

12206 The Minitouch 3.8 Era Office Endometrial Ablation Procedure: 36-Month Outcomes from a Prospective, Multicenter, Pivotal Clinical Trial

Synthetic medial meniscus implant demonstrates high reoperation rates: Patients who retain implant or require implant exchange show improvement in post meniscectomy knee pain and clinical function

PurposeThe purpose of this study was to evaluate the clinical outcomes in the use of a synthetic medial meniscus implant in patients symptomatic after medial meniscectomy and not responsive to other treatment methods. and not responded to non-operative treatment. MethodsThis single-arm, multicenter, prospective study enrolled subjects between ages 30-75 with post-meniscectomy pain. Changes from baseline to 24-months were measured in the pain subscale of the knee injury and osteoarthritis outcome score (KOOS) and in KOOS overall (average of all five subscales) in patients that had received a medial meniscus implant. Success was a 20-point improvement at 24-months, reoperation rates, and implant failures were recorded. VAS, IKDC, and WOMET scores were also measured. ResultsOf the 115 treated patients 3 (2.6%) were either lost to follow-up or missed the 24-month visit, 48 (43%) patients had at least one subsequent surgery, 12 (10.7%) had the implant permanently removed. Of the remaining 100 patients, the mean KOOS pain improved 28.4 points at 24 months (P <0.001), and mean KOOS overall improved 28.3 points (P < 0.001). Seventy-six percent of subjects had mean scores for KOOS pain above the minimal clinically important difference (MCID) threshold, and 72% of subjects met or exceeded this threshold for KOOS overall. There were 29 patients (25.9%) who underwent implant exchange. The 24-month clinical outcomes were similar between subjects who had an implant exchange and patients who did not have any subsequent implant procedure (P < 0.2). ConclusionThe synthetic medial meniscus demonstrates high reoperation and failure rates. Patients who retained the implant or required implant exchange showed significantly improved pain, function, and quality of life at 24-month follow-up in patients symptomatic following partial medial meniscectomy and failed non-operative management. The high reoperation rate is a concern, and further evaluation is needed to determine any contributing factors.

Behavioral Interventions for Tobacco Cessation in Low and Middle-Income Countries: A Systematic Review and Meta-analysis.

An estimated 78% of the total deaths attributable to smoking tobacco use occurred in low- and middle-income countries (LMICs) in 2019. In addition, smokeless tobacco increases the risk of all-cause mortality, all cancers including upper aero-digestive tract cancer, stomach cancer, ischaemic heart disease (IHD) and stroke; with 88% of the mortality burden being borne by the South-East Asian region. Evidence-based interventions from high income countries (HICs) are not easily transferable to LMICs, as patterns of tobacco use, health beliefs associated with tobacco use, and awareness of specific health risks vary substantially. We synthesised the effectiveness of behavioural interventions for tobacco cessation in LMICs through a systematic review and meta-analysis. Interventional studies which delivered individual behavioural intervention and assessed abstinence from tobacco use were included. We examined the pooled intervention effect at six months post-intervention follow up. For continuous abstinence at six months, the intervention was superior to active comparator (RR 2.32; 95% CI 1.78-3.02), and usual care (RR 4.39; 95% CI 2.38-8.11). For point prevalence abstinence at six months, the intervention was superior to active comparator (RR 1.76; 95% CI 1.28-2.44), and usual care (RR 2.37; 95% CI 1.47-3.81). The statistical heterogeneity was substantial to considerable for all comparisons. Only six studies had an overall low risk of bias. Publication bias was observed for all comparisons, except for 6-month continuous outcomes. Implementation research is needed to understand factors for programme sustainability and equity of impact of behavioural interventions in reducing tobacco use in LMICs. Our review is an important step towards the understanding of effectiveness of behaviour interventions for tobacco cessation suited for low- and middle-income countries and which are responsive to the contextual needs of such countries.

Halo Vest Immobilization: Is It Still a Valid Treatment for Atlantoaxial Fractures?

IntroductionAtlanto-axial injuries pose a significant threat to morbidity and mortality. This retrospective study aims to analyze clinical and radiological results, failure rates, and complications in a series of patients treated with a halo vest, validating the effectiveness of this device through long-term follow-up. Materials and methodsThis study reviewed adult patients with acute upper cervical spine injuries treated with halo vest immobilization from 1994 to 2022. Fracture types were classified based on Computed Tomography (CT) characteristics. Clinical and radiological follow-ups were performed at the end of treatment and at 3 months after the removal of the system. ResultsMost treated patients were males (70%) with a mean age of 38 years. Car accidents were the primary cause of injury (63%). Among 161 patients, 134 had a C2 fracture, 20 had a C1 fracture, 5 had a C1-C2 rotational dislocation, and 2 had other unclassified combined C1/C2 fractures. Patients without additional injuries or neurological deficits had significantly shorter hospitalization (8 vs. 16 days and 12 vs. 22 days, respectively) compared to those with additional injuries (p value<.00001) or neurological deficits (p value=0.00164). At the 6-month follow-up, radiological and clinical outcomes were available for 147 patients. X-rays in 139 cases showed fracture fusion (94.6%). Clinical follow-up revealed normal or slightly reduced range of motion in 144 cases (98%). Pain was absent or episodic in all the patients except one. In 131 cases (89%), an excellent or good clinical result was achieved. Complications did not impact treatment. ConclusionsBased on our results, the halo vest is a valid treatment for atlanto-axial injuries in selected patients. This includes young and middle-aged individuals (up to 65 years old) with C1 and/or C2 fractures. Halo vest treatment is associated with minor complications and yields a high percentage of excellent/good clinical results.

Integrating oral health in stroke care: a critical necessity.

To highlight the critical role of integrating oral health assessments into routine stroke care for better patient outcomes. The Eto et al. study utilizes the modified oral assessment grade (mOAG) to evaluate the oral health of acute ischemic stroke patients upon admission and its predictive value for functional outcomes and hospital-acquired pneumonia (HAP). Evidence from Eto et al. study shows that mOAG scores at admission significantly predict 3-month functional outcomes and the incidence of HAP, emphasizing the need for comprehensive oral evaluations. Integrating oral health assessments into stroke care protocols can improve recovery outcomes, reduce HAP incidence, and lower healthcare costs through preventive oral care. Routine oral health evaluations for stroke patients are crucial for better recovery and overall health outcomes, advocating for policy changes and multidisciplinary approaches to patient care.

Can ischemic stroke patients with mTICI of 2b achieve similar outcomes compared to those with complete recanalization following endovascular therapy?

Background and purposeEndovascular therapy (EVT) has been used as a standard treatment method for patients with large vessel ischemic stroke within 24 h of the onset. The extent of recanalization after EVT can be assessed using the modified thrombolysis in cerebral infarction (mTICI) scale as an accepted angiographic grading system. In this study, we aimed to investigate whether patients with a mTICI grade of 2b achieve similar outcomes compared to those with complete recanalization (mTICI of 3) following EVT for acute ischemic stroke.MethodsA retrospective analysis was conducted on 196 consecutive patients who underwent EVT in a comprehensive stroke center. In the final study, 176 patients were included based on the inclusion criteria. The primary outcome was the 3-month modified Rankin Scale (mRS) of 0–2 considered as a favorable outcome, while excellent outcomes were defined as mRS scores of 0–1.ResultsOur data showed that 59.46% of patients in the mTICI 2b group achieved a favorable outcome, comparable to 58.99% observed in the mTICI 3 group (p = 0.959). Additionally, 54.05% (n = 37) of patients with mTICI 2b achieved an excellent outcome, compared to 51.80% (n = 139) in the mTICI 3 group (p = 0.807). The case fatality rates were also comparable between the groups, with 8.11% in the mTICI 2b group and 10.79% in the mTICI 3 group (p = 0.632). Overall, there were no statistically significant differences between the two groups in terms of 3-month favorable outcomes, excellent outcomes, or mortality.ConclusionSimilar 3-month outcomes can be achieved for ischemic stroke patients undergoing EVT with a mTICI grade of 2b compared to those with a mTICI grade of 3. These data can help clinicians in setting realistic expectations and making informed decisions during EVT procedures.

12-month Safety and Efficacy Outcomes of a Standalone Trabecular Bypass Device

12-month Safety and Efficacy Outcomes of a Standalone Trabecular Bypass Device

BRIVA-ONE study: 12-month outcomes of brivaracetam monotherapy in clinical practice.

This study investigated the effectiveness and tolerability of brivaracetam (BRV) monotherapy in a large series of patients with epilepsy. This was a multicenter, retrospective, observational, non-interventional study in 24 hospitals across Spain. Patients aged ≥18 years who started on BRV monotherapy, either as first-line or following conversion, at least 1 year before database closure were included. Patients were evaluated at baseline and at 3, 6 and 12 months after initiation of BRV monotherapy, in accordance with usual clinical practice at these centers. Data were collected retrospectively from patients' individual charts by participating physicians. The primary effectiveness and safety endpoints were the percentage of seizure-free patients 1 year after initiation of BRV monotherapy and the proportion of patients reporting adverse events (AEs) over the complete follow-up period. Retention rates and subpopulation analysis (levetiracetam switchers, elderly and different etiologies) were also investigated. A total of 276 patients were included (48 with BRV as first-line monotherapy and 228 who converted to BRV monotherapy). The overall retention rate in monotherapy at 12 months was 89.9% (87.5% for first-line monotherapy group; 90.4% for conversion-to-monotherapy group). Seizure-freedom rates at 12 months were 77.8% (75% for first-line monotherapy group; 78.4% for conversion-to-monotherapy group). AEs occurred in 39.5% of patients at 12 months (35.4% for first-line monotherapy group; 40.4% for conversion-to-monotherapy group). Most AEs were mild-to-moderate. The most frequent AEs were irritability (12.3%) and dizziness (10.1%). The most frequent AEs leading to BRV withdrawal were dizziness (1.8%) and memory problems (1.4%). Similar outcomes in terms of effectiveness and tolerability of BRV monotherapy were observed in patients switching from levetiracetam, those with different epilepsy etiologies, and elderly patients. BRV was effective and well tolerated both as first-line monotherapy and following conversion to monotherapy in a real-world setting of patients with epilepsy. The goal of the medical treatment of epilepsy is to ensure best possible patient quality of life, by maximizing seizure control and minimizing medication toxicity. Brivaracetam (BRV) is a new-generation epilepsy treatment that is well tolerated by patients. In our study, monotherapy with BRV reduced seizures in patients who had not received other treatments and in patients who switched from a previous treatment to BRV monotherapy. BRV was well tolerated and also effective in sensitive patients (i.e., the elderly and those who had epilepsy caused by a brain tumor or a brain injury).

Random Forest Prognostication of Survival and 6-Month Outcome In Pediatric Patients Following Decompressive Craniectomy For Traumatic Brain Injury

There is a dearth of literature regarding prognostic and predictive factors for outcome following pediatric decompressive craniectomy (DC) following traumatic brain injury (TBI). The aim of this study was to develop a random forest machine learning algorithm to predict outcomes following DC in pediatrics. This is a multi-institutional retrospective study assessing the 6-month postoperative outcome in pediatric patients that underwent DC. We developed a machine learning model using classification and survival random forest algorithms (CRF and SRF respectively) for the prediction of outcomes. Data was collected on clinical signs, radiographic studies, and laboratory studies. The outcome measures for the CRF were mortality and good or bad outcome based on Glasgow Outcome Scale (GOS) at 6-months. A GOS score of 4 or higher indicated a good outcome. The outcomes for the SRF model assessed mortality at during the follow-up period. A total of 40 pediatric patients were included. There was a hospital mortality rate of 27.5%, and 75.8% of survivors had a good outcome at 6-month follow up. The CRF for 6-month mortality had a ROC AUC of 0.984; whereas, the 6-month good/bad outcome had a ROC AUC of 0.873. The SRF was trained at the 6-month timepoint with a ROC AUC of 0.921. CRF and SRF models successfully predicted 6-month outcomes and mortality following DC in pediatric TBI patients. These results suggest random forest models may be efficacious for predicting outcome in this patient population.

Cardiovascular disease history as a predictor for adverse outcomes in frail older adults admitted to acute geriatric settings: 12-month outcomes from an Australian frailty registry

Abstract Introduction Frailty is common in older adults with cardiovascular disease (CVD), with prevalence between 25-62% (1). The incidence of CVD increases with age, yet the outcomes of frail older adults with a history of CVD who present to acute geriatric settings, is not well understood. Purpose To report the association of CVD and rehospitalisation and/or mortality at 12 months in a cohort of frail older adults enrolled in an Australian frailty registry. Methods A convenience sample of participants enrolled in the frailty registry, with 12-month follow-up completed. The frailty registry is a prospective cohort study of adults admitted to the rehabilitation and aged care departments at two Australian hospitals. Frailty was assessed using the Clinical Frailty Scale (CFS), a score of 1-4 is ‘non-frail’, 5-6 is ‘mild-moderately frail’ and 7-9 is ‘severely frail’ (2). For this study, ‘CVD’ was defined as having a history of either heart failure, stroke, or atrial fibrillation. The cumulative incidence of first rehospitalisation and/or death during the first 12 months post discharge was estimated using one minus the Kaplan-Meier estimate of the survival function. Association between CVD (history of CVD, and type of CVD condition) and the composite endpoint were analysed. Adjusted Hazard Ratios (HRs) and 95% confidence intervals (CIs) were estimated using multivariable Cox models incorporating variables of interest and potential confounders. Results A total of 592 participants were included, median age was 82 years, 59% (n= 349) were female. The majority were frail with 50% (n= 295) classified as mild-moderately frail and 21% (n= 123) classified as severely frail. Almost half (45%, n= 265) had a history of CVD. The incidence of frailty (CFS score ≥5, mild-severely frail) was higher in those with CVD compared to those without CVD (76% vs 66%). A history of CVD was significantly associated with higher rate of first readmission or death within 12 months, compared to no history of CVD (p=0.017) (Figure 1). Of the three CVD conditions, heart failure was the only independent predictor of the composite endpoint (HR 1.60 [CI 1.14 -2.24], p=0.007). A CFS score of mild-moderately frail (HR 1.51 [CI 1.18 - 1.93, p=0.001) and severely frail were also independent predictors of the composite endpoint (HR 1.83 [CI 1.35- 2.48], p=&amp;lt;0.001) (Table 1). Conclusions A history of CVD has a significant impact on adverse outcomes in frail older adults admitted to acute geriatric settings. Frailty according to the CFS was independently predictive of rehospitalisation and mortality in this cohort. Heart failure was the only independent predictor of the composite endpoint. These findings underscore the importance of identifying and addressing CVD and in the context of frailty, emphasising the need for targeted interventions to improve outcomes in this vulnerable population.Figure 1.Table 1.

Atrial fibrillation ablation with temperature-controlled very high-power short-duration, with conventional-power, or with combined modes in clinical practice: 12-month outcomes from SECURE

Abstract Background/Introduction QDM is a contact force-sensing catheter optimized for temperature-controlled radiofrequency ablation in very high-power short-duration (vHPSD; 90 W/4 s), conventional-power (CP; ≤50 W), or vHPSD/CP combined modes. Purpose Evaluate 12-month (M) safety and effectiveness of atrial fibrillation (AF) ablations performed with 3 different ablation modes using the QDM catheter, a frequently used single tip catheter in Europe. Methods SECURE is an observational, prospective, post-market study collecting data on procedures performed per standard-of-care with up to 12M follow-up, in 16 enrolling sites in 8 countries across Europe and Israel. Index pulmonary vein (PV) isolation procedures are reported here. The primary safety endpoint is the incidence of primary adverse events (PAEs); the primary effectiveness endpoint is PV isolation (entrance block) of targeted PVs. Additional endpoints include acute reconnections, incidence of char and steam pop, 12M recurrence, repeat ablation, and healthcare utilization (HCU). Ablation strategy, impedance drop, and catheter stability were analysed with a cloud-based data management and artificial intelligence-powered algorithm. Results Since Feb 2021, 291 patients (70% male, 61±11 yrs, CHA2DS2-VASc 1.9±1.5) completed 12M follow-up in 11 sites. Most patients (175 [60.1%]) were treated for paroxysmal (PAF), 85 (29.2%) for persistent (PsAF), and 31 (10.7%) for long-standing persistent (LsPsAF) AF, under general anaesthesia (44.0%) or sedation (55.7%). A combined workflow was used in 66.0% of ablations, while vHPSD-only and CP-only were used in 13.4% and 20.6% of cases, respectively. Four (1.4%) patients reported a PAE; all resolved, and none were catheter related. Acute effectiveness was achieved in all targeted veins; 5.0% of PVs had acute reconnections, with the most common being the left superior PV. No steam pops were reported; 2 counts of char were noted in PsAF ablations with combined modes. Freedom from documented recurrence were 95.8% for PAF, 88.1% for PsAF, and 73.5% for LsPsAF (Fig 1). Freedom from repeat ablation post-blanking and freedom from cardioversion were both 96.8%. Cardiovascular hospitalization and emergency room visits decreased by 65.3% and 76.5% from 12M pre- to 12M post-procedure, respectively. Application-level analyses showed larger impedance drop and greater catheter stability with vHPSD. In procedures using a combined workflow, vHPSD was used preferentially for most PV segments, except anteriorly on the left wide area circumferential ablation (Fig 2). Conclusions Real-world data demonstrates that AF ablation with the QDM catheter is safe and effective with a low PAE rate, high 12M effectiveness, and reduced HCU. Most procedures were done with combined modes, where vHPSD was used preferentially, except at left anterior thicker regions. Larger impedance drop and greater catheter stability were observed with vHPSD applications.