Circulation, Volume 150, Issue Suppl_1, Page ASu1002-ASu1002, November 12, 2024. Introduction:There is a lack of evidence on the optimal mechanical ventilation (MV) settings after pediatric cardiac arrest. The purpose of this study is to investigate the impact of MV settings on survival to hospital discharge (SHD) with favorable neurologic outcome (FNO) in the early post cardiac arrest period.Methods:We conducted a retrospective cohort study of children admitted to a single center pediatric CICU from 9/2016 – 4/2023. We divided our cohort into two groups: patients who did and did not utilize extracorporeal membrane oxygenation (ECMO)during the 48 hours after ROC. We evaluated the association of average values of various MV settings in the 48 hours post-ROSC/ROC: tidal volume (TV, defined as exhaled tidal volume per kg of body weight), peak inspiratory pressure (PIP), peak end expiratory pressure (PEEP), mean airway pressure (MAP), and fraction of inspired oxygen (FiO2) with the association of our primary outcome, SHD with FNO. We defined SHD with FNO as Pediatric Cerebral Performance Category (PCPC) of 1,2, or 3 or no change from admission to discharge. Unfavorable outcome was defined as death or SHD with PCPC of 4,5, or 6. We conducted univariate and multivariate logistic regression analyses, controlling for CPR duration and maximum lactate in the 6 hours post ROSC/ROC.Results:There were 102 index events during the study period. Patients with SHD with FNO compared to those without had lower CPR duration (6.0 [3.0, 18.0] vs. 22.0 [5.0, 43.0] minutes, p=0.0003), incidence of ECPR use (19/57 (33.33%) vs. 24/45 (53.33%), p=0.04), and epinephrine doses used (2.0 [1.0, 6.0] vs. 6.0 [2.0, 8.0], p=0.001). Table 1 shows the MV settings of patients with and without SHD with FNO by PCPC. We found no associations between TV, PIP, PEEP, MAP, and FiO2 with our primary outcome in both ECMO and non-ECMO cohorts. In patients who utilized ECMO, higher TV was associated with lower chances of SHD with FNO. (See Table 2)Conclusions:In this retrospective cohort study of a single center pediatric CICU, early post-arrest TV was associated with SHD with FNO amongst patient supported with ECMO, but not in those who did not utilize ECMO. We did not find an association of PIP, PEEP, MAP, or FiO2 with any outcomes. Future investigations should focus on whether there is a threshold of TV of MV settings that is associated with better outcomes in ECMO patients.
Risultati per: Linee Guida per le cure post-parto
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Abstract 4144168: Five Years Post Heart Transplant Outcomes in Patients with Amyloidosis: A Single Center Experience
Circulation, Volume 150, Issue Suppl_1, Page A4144168-A4144168, November 12, 2024. Introduction:Many patients with amyloidosis can have advanced cardiac involvement, that drives mortality. Due to lack of definitive therapies that can reverse cardiac infiltration, cardiac replacement is the only hope for these patients. Durable left ventricular assist devices are not a good option; hence heart transplant remains mainstay. We present here long-term outcomes from a single center.Methods:Using EPIC Electronic Health Records’ database Clarity and UNOS center-specific report builder, we abstracted clinical information of patients who underwent a heart transplantation for cardiac amyloidosis at our center from 2004 to 2023.Results:Fifty-one patients underwent heart transplant for cardiac amyloidosis: 32 for Amyloid Light chain (AL) and 19 for Amyloidosis Transthyretin (TTR). Majority were males (Table 1). Of the AL transplants, 6 received concomitant kidney, 2 liver and 2 lung transplantation and of the TTR, 1 received concomitant kidney and 16 concomitant liver transplantation. There were more multi-organs in TTR compared to AL cardiac transplants (17 vs 10, p
Abstract 4144055: Adverse Physical Environment, Housing, and Economic Conditions: Their Impact on Maternal Cardiovascular Health during and Post-Pregnancy
Circulation, Volume 150, Issue Suppl_1, Page A4144055-A4144055, November 12, 2024. Background:Maternal cardiovascular health is a critical concern, particularly during and following pregnancy. Previous studies have highlighted the influence of social determinants on health outcomes, but the specific impact of adverse Physical Environment, Housing, and Economic Conditions on maternal cardiovascular health remains underexplored.Methods:Using the TriNetX global health research network within the US Collaborative Network, we explored how adverse Physical Environment, Housing, and Economic Conditions (ICD10CM: Z58 and ICD10CM: Z59) impact maternal cardiovascular health during pregnancy and within one year postpartum. Using, propensity score matching (PSM) analysis, our study compared two cohorts: women aged 15 to 60 who experienced issues related to Physical Environment, Housing, and Economic Conditions during or after pregnancy from 2008 to 2023, and women in the same age range who did not face such issues, thus representing a favorable physical environment, housing, and economic conditions.Results:Challenges related to the physical environment, housing, and economic conditions significantly increased the risk of all-cause mortality (OR: 3.237, 95% CI: 2.064 to 5.075, p
Abstract 4143906: Prophylactic Administration Of Colchicine Mitigates Atrial Fibrillation Vulnerability Post-Catheter Ablation In Rats: Exploring Sex-Specific Variations.
Circulation, Volume 150, Issue Suppl_1, Page A4143906-A4143906, November 12, 2024. Background:Atrial Fibrillation (AF) is the most diagnosed cardiac arrhythmia in clinical practice. Catheter ablation (ABLA) is a method used to manage AF by cauterizing the left atrium (LA) to isolate arrhythmogenic areas. However, ABLA is paradoxically associated with atrial inflammation and AF recurrence, with 10% of patients experiencing recurrence within 30 days and over 50% after 12 months. Studies suggest that AF prevalence is generally lower in women than in men, but females with AF are more prone to severe complications. Colchicine has been proposed for its anti-inflammatory and cardioprotective effects.Hypothesis:Early colchicine treatment prevents ABLA-triggered atrial fibrosis, inflammation, and arrhythmogenic substrates.Methods:Male and female Wistar rats (225-275g) were randomly assigned to four groups: Sham or ABLA, with or without colchicine treatment (1 mg/kg/day; intraperitoneally) starting 2 hours before surgery. Sham animals underwent surgery without ABLA.In vivoelectrophysiological studies and echocardiography were performed on days 1 (D1) and 3 (D3) post-ABLA. On D3,ex-vivooptical mapping was conducted on Langendorff-perfused hearts, and atrial fibrosis, gene, and protein expression were assessed using Masson’s trichrome staining, qPCR, and immunoblotting, respectively.Results:ABLA animals displayed a significantly higher susceptibility to atrial arrhythmias compared to Sham animals, and among ABLA rats, females were 20% less vulnerable to AF than males at D3 post-ABLA. The LA from ABLA rats exhibited significantly slowed conduction velocity, increased fibrosis areas, and enhanced levels of inflammatory markers compared to Sham. Colchicine significantly reduced the incidence of AF post-ABLA with more efficacy in females than males. Moreover, colchicine normalized LA conduction, fibrosis, and inflammation in LA ABLA compared to Sham. Consistent with contemporary knowledge about male and female differences in AF incidence, our data suggest that endogenous female sex hormones combined with colchicine administration may contribute to significantly reducing AF incidence.Conclusion:Initiating Colchicine treatment prior to ABLA may lower post-ABLA-induced LA inflammation and AF occurrence. Delving into the variances in male and female responses to colchicine intervention could offer new insights into addressing post-ABLA AF incidence.Bas du formulaire
Abstract 4146618: Differential Impact of Left Atrial Volume on Post-Ablation Recurrence Rates in Patients with Normal and Reduced Left Atrial Ejection Fraction: A DECAAF II Subanalysis
Circulation, Volume 150, Issue Suppl_1, Page A4146618-A4146618, November 12, 2024. Background:The left atrial volume (LAV) has been known to be positively correlated with the atrial fibrillation (AF) recurrence rates after catheter ablation (CA) but negatively correlated with the left ventricular ejection fraction (LVEF). We hypothesized that LAV plays different roles for patients with normal LVEF (LVEF ≥ 50%) and those with lower LVEF (LVEF < 50%).Method:Out of 843 patients from the DECAAF II trial, 674 patients with baseline LAV and LVEF data were included. Among these, 506 patients were characterized as having normal LVEF, while 168 patients had lower LVEF. For each group, the effect of LAV was studied against the AF recurrence through the Cox model, adjusting for age, sex, baseline LA fibrosis, and comorbidities, including coronary artery disease (CAD), hypertension (HTN), congestive heart failure (CHF), diabetes (DM), and hyperlipidemia (HLD). Patients were further divided into high and low LAV groups and compared performance after CA through the Kaplan-Meier curves and log-rank tests.Result:From Cox models, in the high LVEF group, LAV was identified as a significant predictor of the AF recurrence, with a hazard ratio (HR) of 1.009 (95% CI: 1.006-1.013, p < 0.001) for each unit of increase (Table 1a). In the low LVEF group, LAV was not associated with AF recurrence (Table 1b). As in Figure 1, among lower LVEF patients, high LAV and low LAV provide similar AF recurrence rates. However, low LAV patients with normal LVEF have the lowest AF recurrence rate, while high LAV and normal LVEF patients have the highest AF recurrence rates after CA (p < 0.001).Conclusion:The study found that baseline left atrial volume (LAV) is a strong predictor of AF recurrence after CA for patients with normal LVEF but not for patients with lower LVEF. Patients with large LAV and normal LVEF have even worse outcomes compared to those with large LAV and lower LVEF.
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Factors affecting the feasibility of post-authorisation RCTs for conditionally authorised anticancer medicines: a multistakeholder perspective from a qualitative focus group study
Objective
The collection of comprehensive data from post-authorisation trials for conditionally authorised anticancer medicines is frequently delayed. This raises questions about the feasibility of post-authorisation randomised controlled trials (RCTs) that aim to address remaining uncertainties. Therefore, this study explored factors that facilitate or impede the feasibility of post-authorisation RCTs from the perspective of stakeholders directly involved in the design, medical-ethical approval, and conduct of these RCTs.
Design
We conducted four qualitative focus groups (FGs).
Setting
FG discussions focused on the oncology setting in European context.
Participants
Twenty-eight European patients, physicians, medical ethicists and pharmaceutical industry representatives participated in the FGs.
Intervention
Respondents were informed about the topic and the purpose of the FGs before and at the start of FG discussions. An FG script was used to guide the discussion, which was informed by 14 semi-structured interviews with various stakeholders.
Results
We identified factors with the potential to impact feasibility related to trial design, trial conduct, factors external to a trial and post-authorisation interaction with regulators. Factors that may be particularly relevant for the post-authorisation setting include the choice of relevant endpoints and the inclusion of a fair comparator (trial design), strategies to increase patients’ and physicians’ willingness to participate (trial conduct), and external factors relating to a medicine’s commercial availability, the presence of competing medicines and trials and the perceptions about clinical equipoise. Post-authorisation interaction with regulators about how to obtain comprehensive data was deemed necessary in cases where a post-authorisation RCT seems infeasible.
Conclusions
Based on the identified factors, our findings suggest that patient recruitment and retention could be assessed more in-depth during regulatory feasibility assessments at the time of granting conditional marketing authorisation and that sponsors and regulators should better inform patients and physicians about the remaining uncertainties for conditionally authorised medicines and the necessity for post-authorisation RCTs. By enhancing the evaluation of trial feasibility, timely completion of post-authorisation RCTs may be facilitated to resolve the remaining uncertainties within a reasonable timeframe.
Diagnosi di Fibrosi Cistica: Linee Guida Consensuali della Cystic Fibrosis Foundation
Pancreatite acuta: diagnosi, valutazione di gravità, terapia medica ed endoscopica e gestione del post-acuzie
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Riviste le linee guida diagnostiche per l’Alzheimer
Istat: 'Più italiani rinunciano alle cure, 7,6% nel 2023'
Chelli: ‘Cala la spesa sanitaria nel 2023 e aumenta il carico per le famiglie’