Person: Munoz Venturelli, Paula
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Munoz Venturelli
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Publication Implementation of a goal-directed Care Bundle for intracerebral hemorrhage: Results of embedded process evaluation in the INTERACT3 trial(2024) Ouyang, Menglu; Anjum, Anila; Gonzalez, Francisca; Wasay, Mohammad; Ma, Lu; Hu, Xin; Chen, Xiaoying; Malavera, Alejandra; Li, Xi; Munoz Venturelli, Paula; De Silva, Asita; Nguyen Huy Thang; Wahab, Kolawole; Pandian, Jeyaraj; Pontes-Neto, Octavio; Abanto, Carlos; Cano-Nigenda, Venessa; Arauz, Antonio; You, Chao; Jan, Stephen; Song, Lili; Anderson, Craig; Liu, Hueiming; INTERACT3 InvestigatorsThe third, stepped-wedge, cluster-randomized, Intensive Care Bundle with Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT3), has shown that a goal-directed multi-faceted Care Bundle incorporating protocols for the management of physiological variables was safe and effective for improving functional recovery in a broad range of patients with acute intracerebral hemorrhage (ICH). The INTERACT3 Care Bundle included time- and target-based protocols for the management of early intensive lowering of systolic blood pressure (SBP, target <140mmHg), glucose control (target 6.1-7.8 mmol/L in those without diabetes and 7.8-10.0 mmol/L in those with diabetes), anti-pyrexia treatment (target body temperature ≤37.5°C), and the rapid reversal of warfarin-related anticoagulation (target international normalized ratio <1.5). An embedded process evaluation was conducted to allow a better understanding of how the Care Bundle was implemented in different countries to enhance the transferability of this evidence in the international context. This study used a mixed-methods approach involving interviews, focus group discussions, and surveys to evaluate the implementation outcomes included fidelity, dose, reach, acceptability, appropriateness, adoption, and sustainability. Interviews (n = 27), focus group discussions (n = 3), and quantitative surveys (n = 48) were conducted in 7 low- and middle-income countries (LMICs) and 1 high-income country during 2019-2022. The Care Bundle was generally delivered as planned and well accepted by stakeholders, although some difficulties were reported in reaching the SBP and glycemic targets. Contextual factors including staff shortage, limited availability of antihypertensive drugs, and delayed systems of care processes, were common barriers to implementing the Care Bundle. Facilitating factors included good communication and collaboration with staff in emergency departments, the development of pathways within available resources, and regular training and monitoring. Our process evaluation provides useful insights into the contextual barriers which need to be addressed for effective scale up of the Care Bundle implementation in a global context. Trial registration: INTERACT3 is registered at Clinicaltrials.gov (NCT03209258) and the Chinese Clinical Trial Registry (ChiCTR-IOC-17011787).Publication Post-COVID-19 condition: a sex-based analysis of clinical and laboratory trends(2024) Delfino, Carlos; Poli Harlowe, María Cecilia; Vial Cox, María Cecilia; Vial, Pablo; Martínez, Gonzalo; Riviotta, Amy; Arbat, Catalina; Mac-Guire, Nicole; Hoppe, Josefina; Carvajal, Cristóbal; Munoz Venturelli, PaulaBackground and aim: Post-COVID-19 condition (PCC) encompasses long-lasting symptoms in individuals with COVID-19 and is estimated to affect between 31-67% of patients, with women being more commonly affected. No definitive biomarkers have emerged in the acute stage that can help predict the onset of PCC, therefore we aimed at describing sex-disaggregated data of PCC patients from a local cohort and explore potential acute predictors of PCC and neurologic PCC. Methods: A local cohort of consecutive patients admitted with COVID-19 diagnosis between June 2020 and July 2021 were registered, and clinical and laboratory data were recorded. Only those <65 years, discharged alive and followed up at 6 and 12 months after admission were considered in these analyses. Multivariable logistic regression analysis was performed to explore variables associated with PCC (STATA v 18.0). Results: From 130 patients in the cohort, 104 were contacted: 30% were women, median age of 42 years. At 6 months, 71 (68%) reported PCC symptoms. Women exhibited a higher prevalence of any PCC symptom (87 vs. 60%, p = 0.007), lower ferritin (p = 0.001) and procalcitonin (p = 0.021) and higher TNF levels (p = 0.042) in the acute phase compared to men. Being women was independently associated to 7.60 (95% CI 1.27-45.18, p = 0.026) higher risk for PCC. Moreover, women had lower return to normal activities 6 and 12 months. Conclusion: Our findings highlight the lasting impact of COVID-19, particularly in young women, emphasising the need for tailored post-COVID care. The lower ferritin levels in women are an intriguing observation, warranting further research. The study argues for comprehensive strategies that address sex-specific challenges in recovery from COVID-19.Publication Role of inflammation and evidence for the use of colchicine in patients with acute coronary syndrome(2024) Bulnes, Juan; González, Leticia; Velásquez , Leonardo; Orellana, María; Munoz Venturelli, Paula; Martínez, GonzaloAcute Coronary Syndrome (ACS) significantly contributes to cardiovascular death worldwide. ACS may arise from the disruption of an atherosclerotic plaque, ultimately leading to acute ischemia and myocardial infarction. In the pathogenesis of atherosclerosis, inflammation assumes a pivotal role, not solely in the initiation and complications of atherosclerotic plaque formation, but also in the myocardial response to ischemic insult. Acute inflammatory processes, coupled with time to reperfusion, orchestrate ischemic and reperfusion injuries, dictating infarct magnitude and acute left ventricular (LV) remodeling. Conversely, chronic inflammation, alongside neurohumoral activation, governs persistent LV remodeling. The interplay between chronic LV remodeling and recurrent ischemic episodes delineates the progression of the disease toward heart failure and cardiovascular death. Colchicine exerts anti-inflammatory properties affecting both the myocardium and atherosclerotic plaque by modulating the activity of monocyte/macrophages, neutrophils, and platelets. This modulation can potentially result in a more favorable LV remodeling and forestalls the recurrence of ACS. This narrative review aims to delineate the role of inflammation across the different phases of ACS pathophysiology and describe the mechanistic underpinnings of colchicine, exploring its purported role in modulating each of these stages.Publication Recommendations for Implementing the INTERACT3 CareBundle for Intracerebral Hemorrhagein Latin America: Results of a Delphi Method(2024) Allende, María Ignacia; Munoz Venturelli, Paula; González, Francisca; Bascur, Francisca; Craig S., Anderson; Ouyang, Menglu; Cabieses, Báltica; Obach, Alexandra; Cano-Nigenda, Vanessa; Arauz, Antonio; LATAM INTERACT3 Consensus Statement PanelIntroduction: The third Intensive Care Bundle with Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT3) showed that the implementation of a care bundle improves outcomes after acute intracerebral hemorrhage (ICH). We aimed to establish consensus-based recommendations for the broader integration of the care bundle across Latin American countries (LAC). Methods: A 3-phase Delphi study allowed a panel of 32 healthcare workers from 14 LAC to sequentially rank statements relevant to 7 domains (training, resources/infrastructure, patient education, blood pressure, temperature, glycemic control, and anticoagulation reversal). The pre-defined consensus threshold was 75%. Results: A total of 43 statements reached consensus by the third round, with 12 new statements emerging through rounds. The highest-ranked statements in each domain emphasized critical aspects, but successful implementation requires appropriate resourcing. Key priorities were continuous training of all healthcare workers in ICH management, establishing protocols aligned with available resources, and collaborative interdisciplinary care supported by institutional networks. Statements related to anticoagulation reversal had the highest priority. Conclusions: Consensus statements are provided to facilitate integration of the INTERACT3 care bundle to reduce disparities in ICH outcomes in LAC.Publication Dilated optic nerve sheath by ultrasound predicts mortality among patients with acute intracerebral hemorrhage(2023) Antunes, Francisco; Zanon, Maria; Fernandes, Frederico; Martins Filho, Kleber do Vale; Monteiro, Clara; Costa, Otavio; Munoz Venturelli, Paula; Boulouis, Gregoire; Norkin, Joshua; Marques, OctavioBackground: Intracerebral hemorrhage (ICH) is a deadly disease and increased intracranial pressure (ICP) is associated with worse outcomes in this context. Objective: We evaluated whether dilated optic nerve sheath diameter (ONSD) depicted by optic nerve ultrasound (ONUS) at hospital admission has prognostic value as a predictor of mortality at 90 days. Methods: Prospective multicenter study of acute supratentorial primary ICH patients consecutively recruited from two tertiary stroke centers. Optic nerve ultrasound and cranial computed tomography (CT) scans were performed at hospital admission and blindly reviewed. The primary outcome was mortality at 90-days. Multivariate logistic regression, ROC curve, and C-statistics were used to identify independent predictors of mortality. Results: Between July 2014 and July 2016, 57 patients were evaluated. Among those, 13 were excluded and 44 were recruited into the trial. Their mean age was 62.3 ± 13.1 years and 12 (27.3%) were female. On univariate analysis, ICH volume on cranial CT scan, ICH ipsilateral ONSD, Glasgow coma scale, National Institute of Health Stroke Scale (NIHSS) and glucose on admission, and also diabetes mellitus and current nonsmoking were predictors of mortality. After multivariate analysis, ipsilateral ONSD (odds ratio [OR]: 6.24; 95% confidence interval [CI]: 1.18-33.01; p = 0.03) was an independent predictor of mortality, even after adjustment for other relevant prognostic factors. The best ipsilateral ONSD cutoff was 5.6mm (sensitivity 72% and specificity 83%) with an AUC of 0.71 (p = 0.02) for predicting mortality at 90 days. Conclusion: Optic nerve ultrasound is a noninvasive, bedside, low-cost technique that can be used to identify increased ICP in acute supratentorial primary ICH patients. Among these patients, dilated ONSD is an independent predictor of mortality at 90 days. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution 4.0 International License, permitting copying and reproduction so long as the original work is given appropriate credit (https://creativecommons.org/licenses/by/4.0/).Publication The third Intensive Care Bundle with Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT3): an international, stepped wedge cluster randomised controlled trial(2023) Ma, Lu; Hu, Xin; Song, Lili; Chen, Xiaoying; Ouyang, Menglu; Billot, Laurent; Li, Qiang; Malavera, Alejandra; Li, Xi; Munoz Venturelli, Paula; De Silva, Asita; Huy Thang, Nguyen; Wahab, Kolawole; Pandian, Jeyaraj; Wasay, Mohammad; Pontes, Octavio; Abanto, Carlos; Arauz, Antonio; Shi, Haiping; Tang, Guanghai; Zhu, Sheng; She, Xiaochun; Liu, Leibo; Sakamoto, Yuki; You, Shoujiang; Han, Qiao; Crutzen, Bernard; Cheung, Emily; Li, Yunke; Wang, Xia; Chen, Chen; Liu, Feifeng; Zhao, Yang; Li, Hao; Liu, Yi; Jiang, Yan; Chen, Lei; Wu, Bo; Liu, Ming; Xu, Jianguo; INTERACT3 InvestigatorsBackground: Early control of elevated blood pressure is the most promising treatment for acute intracerebral haemorrhage. We aimed to establish whether implementing a goal-directed care bundle incorporating protocols for early intensive blood pressure lowering and management algorithms for hyperglycaemia, pyrexia, and abnormal anticoagulation, implemented in a hospital setting, could improve outcomes for patients with acute spontaneous intracerebral haemorrhage. Methods: We performed a pragmatic, international, multicentre, blinded endpoint, stepped wedge cluster randomised controlled trial at hospitals in nine low-income and middle-income countries (Brazil, China, India, Mexico, Nigeria, Pakistan, Peru, Sri Lanka, and Viet Nam) and one high-income country (Chile). Hospitals were eligible if they had no or inconsistent relevant, disease-specific protocols, and were willing to implement the care bundle to consecutive patients (aged ≥18 years) with imaging-confirmed spontaneous intracerebral haemorrhage presenting within 6 h of the onset of symptoms, had a local champion, and could provide the required study data. Hospitals were centrally randomly allocated using permuted blocks to three sequences of implementation, stratified by country and the projected number of patients to be recruited over the 12 months of the study period. These sequences had four periods that dictated the order in which the hospitals were to switch from the control usual care procedure to the intervention implementation of the care bundle procedure to different clusters of patients in a stepped manner. To avoid contamination, details of the intervention, sequence, and allocation periods were concealed from sites until they had completed the usual care control periods. The care bundle protocol included the early intensive lowering of systolic blood pressure (target <140 mm Hg), strict glucose control (target 6·1-7·8 mmol/L in those without diabetes and 7·8-10·0 mmol/L in those with diabetes), antipyrexia treatment (target body temperature ≤37·5°C), and rapid reversal of warfarin-related anticoagulation (target international normalised ratio <1·5) within 1 h of treatment, in patients where these variables were abnormal. Analyses were performed according to a modified intention-to-treat population with available outcome data (ie, excluding sites that withdrew during the study). The primary outcome was functional recovery, measured with the modified Rankin scale (mRS; range 0 [no symptoms] to 6 [death]) at 6 months by masked research staff, analysed using proportional ordinal logistic regression to assess the distribution in scores on the mRS, with adjustments for cluster (hospital site), group assignment of cluster per period, and time (6-month periods from Dec 12, 2017). This trial is registered at Clinicaltrials.gov (NCT03209258) and the Chinese Clinical Trial Registry (ChiCTR-IOC-17011787) and is completed. Findings: Between May 27, 2017, and July 8, 2021, 206 hospitals were assessed for eligibility, of which 144 hospitals in ten countries agreed to join and were randomly assigned in the trial, but 22 hospitals withdrew before starting to enrol patients and another hospital was withdrawn and their data on enrolled patients was deleted because regulatory approval was not obtained. Between Dec 12, 2017, and Dec 31, 2021, 10 857 patients were screened but 3821 were excluded. Overall, the modified intention-to-treat population included 7036 patients enrolled at 121 hospitals, with 3221 assigned to the care bundle group and 3815 to the usual care group, with primary outcome data available in 2892 patients in the care bundle group and 3363 patients in the usual care group. The likelihood of a poor functional outcome was lower in the care bundle group (common odds ratio 0·86; 95% CI 0·76-0·97; p=0·015). The favourable shift in mRS scores in the care bundle group was generally consistent across a range of sensitivity analyses that included additional adjustments for country and patient variables (0·84; 0·73-0·97; p=0·017), and with different approaches to the use of multiple imputations for missing data. Patients in the care bundle group had fewer serious adverse events than those in the usual care group (16·0% vs 20·1%; p=0·0098). Interpretation: Implementation of a care bundle protocol for intensive blood pressure lowering and other management algorithms for physiological control within several hours of the onset of symptoms resulted in improved functional outcome for patients with acute intracerebral haemorrhage. Hospitals should incorporate this approach into clinical practice as part of active management for this serious condition. Funding: Joint Global Health Trials scheme from the Department of Health and Social Care, the Foreign, Commonwealth & Development Office, and the Medical Research Council and Wellcome Trust; West China Hospital; the National Health and Medical Research Council of Australia; Sichuan Credit Pharmaceutic and Takeda China.Publication Genetics of spontaneous cervical and coronary artery dissections(2023) Munoz Venturelli, Paula; Rada, Isabel; Calderón, Juan; Martínez, GonzaloObjectives: Spontaneous cervical artery dissections (SCeAD) and coronary artery dissections (SCoAD) are major causes of neurovascular and cardiovascular morbidity in young adults. Although multiple aspects of their etiology are still unknown, most consensuses are focused on the presence of constitutional genetic aspects and environmental triggers. Since recent evidence of genetic contribution points to a possible overlap between these conditions, we aimed to describe current information on SCeAD and SCoAD genetics and their potential shared pathological aspects. Materials and methods: A narrative review is presented. Publications in English and Spanish were queried using database search. The articles were evaluated by one team member in terms of inclusion criteria. After collecting, the articles were categorized based on scientific content. Results: Given that patients with SCeAD and SCoAD rarely present connective tissue disorders, other genetic loci are probably responsible for the increased susceptibility in some individuals. The common variant rs9349379 at PHACTR1 gene is associated with predisposition to pathologies of the arterial wall, likely mediated by variations in Endothelin-1 (ET-1) levels. The risk of arterial dissection may be increased for those who carry the rs9349379(A) allele, associated with lower expression levels of ET-1; however, the local effect of this vasomotor imbalance remains unclear. Sex differences seen in SCeAD and SCoAD support a role for sex hormones that could modulate risk, tilting the delicate balance and forcing vasodilator actions to prevail over vasoconstriction due to a reduction in ET-1 expression. Conclusions: New evidence points to a common gene variation that could explain dissection in both the cervical and coronary vasculatures. To further confirm the risk conferred by the rs9349379 variant, genome wide association studies are warranted, hopefully in larger and ethnically diverse populations.Publication Sex Differences in Profile and In-Hospital Death for Acute Stroke in Chile: Data From a Nationwide Hospital Registry(2024) Nuñez, Marilaura; Allende, María; González, Francisca; Cavada, Gabriel; Anderson, Craig; Munoz Venturelli, PaulaBackground: Knowledge of local contextual sex differences in the profile and outcome for stroke can improve service delivery. We aimed to determine sex differences in the profile of patients with acute stroke and their associations with in-hospital death in the national hospital database of Chile. Methods and results: We present a retrospective cohort based on the analysis of the 2019 Chilean database of Diagnosis-Related Groups, which represents 70% of the operational expenditure of the public health system. Random-effects multiple logistic regression models were used to determine independent associations of acute stroke (defined by main diagnosis International Classification of Diseases, Tenth Revision [ICD-10] codes) and in-hospital death, and reported with odds ratios (ORs) and 95% CIs. Of 1 048 575 hospital discharges, 15 535 were for patients with acute stroke (7074 [45.5%] in women), and 2438 (15.6%) of them died during hospitalization. Differences by sex in sociodemographic and clinical characteristics were identified for stroke and main subtypes. After fully adjusted model, women with ischemic stroke had lower in-hospital death (OR, 0.79 [95% CI, 0.69-0.91]) compared with men; other independent predictors included age per year increase (OR, 1.03 [95% CI, 1.03-1.04]), chronic kidney disease (OR, 1.47 [95% CI, 1.20-1.80]), atrial fibrillation (OR, 1.50 [95% CI, 1.26-1.80]), and other risk factors. Conversely, for intracerebral hemorrhage, women had a higher in-hospital mortality rate than men (OR, 1.19 [95% CI, 1.02-1.40]); other independent predictors included age per year increase (OR, 1.009 [95% CI, 1.003-1.01]), chronic kidney disease (OR, 1.55 [95% CI, 1.23-1.97]), oral anticoagulant use (OR, 1.88 [95% CI, 1.37-2.58]), and other risk factors. Conclusions: Sex differences in characteristics and in-hospital death of hospitalized patients exist for acute stroke in Chile. In-hospital death is higher for acute ischemic stroke in men and higher for intracerebral hemorrhage in women. Future research is needed to better identify contributing factors.Publication Diffusion-weighted imaging as predictor of acute ischemic stroke etiology(2022) Brunser, Alejandro; Mansilla, Eloy; Navia, Víctor; Mazzon, Enrico; Rojo, Alexis; Cavada, Gabriel; Olavarría, Verónica V.; Munoz Venturelli, Paula; Lavados, PabloBackground: Topographic patterns may correlate with causes of ischemic stroke. Objective: To investigate the association between diffusion weighted imaging (DWI) and Trial of Org 10172 in Acute Stroke Treatment (TOAST) classification. Methods: We included 1019 ischemic stroke patients. DWI were classified as: i) negative; ii) DWI single lesion (cortico-subcortical, cortical, subcortical ≥20 mm, or subcortical <20 mm); iii) scattered lesions in one territory (small scattered lesions or confluent with additional lesions); and iv) multiple lesions (multiple unilateral anterior circulation [MAC], multiple posterior circulation [MPC], multiple bilateral anterior circulation [MBAC], and multiple anterior and posterior circulations [MAP]). Results: There was a relationship between DWI patterns and TOAST classification (p<0.001). Large artery atherosclerosis was associated with small, scattered lesions in one vascular territory (Odds Ratio [OR] 4.22, 95% confidence interval [95%CI] 2.61–6.8), MPC (OR 3.52; 95%CI 1.54–8.03), and subcortical lesions <20 mm (OR 3.47; 95%CI 1.76–6.85). Cardioembolic strokes correlated with MAP (OR 4.3; 95%CI 1.64–11.2), cortico-subcortical lesions (OR 3.24; 95%CI 1.9–5.5) and negative DWI (OR 2.46; 95%CI 1.1–5.49). Cryptogenic strokes correlated with negative DWI (OR 4.1; 95%CI 1,84–8.69), cortical strokes (OR 3.3; 95%CI 1.25–8.8), MAP (OR 3.33; 95%CI 1.25–8.81) and subcortical lesion ≥20 mm (OR 2.44; 95%CI 1,04–5.73). Lacunar strokes correlated with subcortical lesions diameter <20 mm (OR 42.9; 95%CI 22.7–81.1) and negative DWI (OR 8.87; 95%CI 4.03–19.5). Finally, MBAC (OR 9.25; 95%CI 1.12–76.2), MAP (OR 5.54; 95%CI 1.94–15.1), and MPC (OR 3.61; 95%CI 1.5–8.7) correlated with stroke of other etiologies. Conclusions: A relationship exists between DWI and stroke subtypePublication Who is in the emergency room matters when we talk about door-to-needle time: a single-center experience [Quien está en el servicio de emergencia importa al hablar de tiempo puerta-aguja: experiencia de un centro clínico](2023) Brunser, Alejandro; Nuñez; Juan; Mansilla, Eloy; Cavada, Gabriel; Olavarría, Verónica V.; Munoz Venturelli, Paula; Lavados, PabloBackground: The efficacy of intravenous thrombolysis (IVT) is time-dependent. Objective: To compare the door-to-needle (DTN) time of stroke neurologists (SNs) versus non-stroke neurologists (NSNs) and emergency room physicians (EPs). Additionally, we aimed to determine elements associated with DTN ≤ 20 minutes. Methods: Prospective study of patients with IVT treated at Clínica Alemana between June 2016 and September 2021. Results: A total of 301 patients underwent treatment for IVT. The mean DTN time was 43.3 ± 23.6 minutes. One hundred seventy-three (57.4%) patients were evaluated by SNs, 122 (40.5%) by NSNs, and 6 (2.1%) by EPs. The mean DTN times were 40.8 ± 23, 46 ± 24.7, and 58 ± 22.5 minutes, respectively. Door-to-needle time ≤ 20 minutes occurred more frequently when patients were treated by SNs compared to NSNs and EPs: 15%, 4%, and 0%, respectively (odds ratio [OR]: 4.3, 95% confidence interval [95%CI]: 1.66–11.5, p = 0.004). In univariate analysis DTN time ≤ 20 minutes was associated with treatment by a SN ( p = 0.002), coronavirus disease 2019 pandemic period ( p = 0.21), time to emergency room (ER) ( p = 0.21), presence of diabetes ( p = 0.142), hypercholesterolemia ( p = 0.007), atrial fibrillation ( p < 0.09), score on the National Institutes of Health Stroke Scale (NIHSS) ( p = 0.001), lower systolic ( p = 0.143) and diastolic ( p = 0.21) blood pressures, the Alberta Stroke Program Early CT Score (ASPECTS; p = 0.09), vessel occlusion ( p = 0.05), use of tenecteplase ( p = 0.18), thrombectomy ( p = 0.13), and years of experience of the physician ( p < 0.001). After multivariate analysis, being treated by a SN (OR: 3.95; 95%CI: 1.44–10.8; p = 0.007), NIHSS (OR: 1.07; 95%CI: 1.02–1.12; p < 0.002) and lower systolic blood pressure (OR: 0.98; 95%CI: 0.96–0.99; p < 0.003) remained significant. Conclusion: Treatment by a SN resulted in a higher probability of treating the patient in a DTN time within 20 minutes.