Circulation, Volume 150, Issue Suppl_1, Page A4145353-A4145353, November 12, 2024. Background:Myocardial injury complicating percutaneous coronary intervention (PCI) is associated with mortality, but sex differences in outcomes are uncertain. We explored sex differences in the incidence and long-term outcomes of post-PCI myocardial injury (PPMI).Methods:Adults who underwent PCI at NYU between 2011-2020 were included in this retrospective analysis. Patients with ACS as the indication for PCI were excluded. PPMI was defined as a peak CKMB concentration >99% of the upper reference limit. The incidence of PPMI by sex was compared by Chi-square tests. Independent predictors of elevated CKMB post-PCI were evaluated with linear regression models in subgroups by sex. Cox proportional hazard models were generated to evaluate relationships between PPMI and all-cause mortality by sex.Results:Of 10,807 adults undergoing PCI, 24.9% (2,694) were female. Females were older than males at the time of PCI (68.9 vs. 65.8, p
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Abstract 4146021: Post transcatheter aortic valve replacement outcomes among patients with heart failure with preserved ejection fraction versus heart failure with reduced ejection fraction.
Circulation, Volume 150, Issue Suppl_1, Page A4146021-A4146021, November 12, 2024. Background:Heart failure with preserved ejection fraction (HFpEF) or heart failure with reduced ejection fraction (HFrEF) is a common comorbidity in patients undergoing transcatheter aortic valve replacement (TAVR). However, post-TAVR outcomes among HFpEF and HFrEF patients have not been well studied.Objective:This study aims to investigate the clinical outcomes post-TAVR among patients with HFrEF vs. HFpEF.Methods:The TriNeTX Global Collaborative Network research database was used to identify patients aged ≥18 years from January 2005 to May 2023. Patients were categorized into two groups: HFpEF and a control group with HFrEF, with both groups of patients undergoing TAVR and followed for 1-month and 1-year. Propensity score-matched analysis (PSM) (1:1) was performed on age, gender, race, body mass index, hypertension, diabetes mellitus, chronic kidney disease, smoking status, hemoglobin level, low density lipid (LDL) level, and various drugs including ACEi, ARBi, beta-blockers, SGLT2i and statins. Primary outcome was all-cause mortality (ACM), while secondary outcomes were acute myocardial infarction (AMI), ischemic stroke, hemorrhagic stroke, major bleeding and major adverse cardiovascular event (MACE) (composite of ACM, AMI and ischemic stroke).Results:After 1:1 propensity score matching (Figure 1), the study cohort comprised of 11, 982 patients in HFpEF with TAVR and 11, 982 patients in the control group. The mean age of patients in HFpEF and HFrEF was 81.7 and 81.5 years, respectively. PSM analysis showed that post-TAVR outcomes among HFpEF patients were significantly associated with lower risk of ACM after 1-month (RR, 0.88 (95%CI: 0.707-0.953),P=0.009), and after 1-year (RR, 0.93 (95% CI: 0.87-0.99),P=0.041) compared with the HFrEF group. A similar trend was observed with a significant reduction in the risk of MACE after 1-month (RR, 0.86, (95% CI: 0.74-0.99),P=0.043), however, it was non-significant after 1-year (RR, 0.942 (95% CI: 0.881-1.007),P=0.077). However, the risk of AMI, ischemic stroke, hemorrhagic stroke, major bleeding both at 1-month and 1-year follow up were comparable between the HFpEF and HFrEF post-TAVR.Conclusion:In patients with HFpEF post-TAVR, there was a significant decrease in ACM at 1-month and 1-year, while there was a significant reduction in MACE only at 1-month. Further investigation is warranted to determine whether HFpEF has better clinical outcomes than patients with HFrEF.
Abstract 4118018: Increased Risk of Post-Transplant Malignancy After Isolated Heart Transplant in Adult Patients with Congenital Heart Disease
Circulation, Volume 150, Issue Suppl_1, Page A4118018-A4118018, November 12, 2024. Introduction:Patients with congenital heart disease (CHD) are at increased risk of cancer. In patients with CHD and advanced heart failure, isolated heart transplantation (HT) can be considered. In the overall HT population, immunosuppression after HT increases the risk of post-transplant malignancy (PTM). However, cancer outcomes among adult HT patients with CHD have not been investigated.Methods:Patients aged ≥ 18 years who received HT between January 1, 2010 and December 31, 2021 were identified using the United Network for Organ Sharing (UNOS) registry. Patients with CHD were compared to those without. Outcomes were PTM and hematologic malignancy (either leukemia, lymphoma or post-transplant lymphoproliferative disorder). Multivariable Fine-Gray competing-risk regression adjusting for age, sex, race, prior cardiac surgery, smoking, diabetes, induction immunosuppression, recipient and donor cytomegalovirus and Ebstein-Bar virus status was used to estimate subhazard ratio (SHR).Results:Of the total of 29,717 patients with HT were included, 1,017 (3.4%) had CHD. Patients with CHD were younger, more likely to be female, and more likely to have had prior cardiac surgery. After multivariable competing-risk regression, CHD was associated with higher risk of PTM (aSHR 1.44, 95% CI 1.15 – 1.80) and hematologic malignancy (aSHR 2.09, 95% CI 1.28 – 3.42). Among patients < 45 years old, CHD had an unadjusted SHR of 1.55 (95% CI 1.11 – 2.16) of PTM, Figure.Conclusions:Among adult patients with HT, CHD was associated with increased risk of PTM and hematologic malignancy. Further investigation is warranted to identify risk factors and screening strategies for malignancy in this patient population.
Abstract 4146947: Obese adolescents supported with VADs have inferior post-transplant outcomes
Circulation, Volume 150, Issue Suppl_1, Page A4146947-A4146947, November 12, 2024. Background:The prevalence of both obesity and the use of left ventricular assist devices (LVAD) is increasing in pediatrics, but what impact obesity has on post-heart transplant (HT) outcomes when using an LVAD as a bridge to transplant (BTT) is unknown.Methods:Retrospective cohort study of patients 12-18 years old in the UNOS database with a durable LVAD and listed for heart transplant (HT) between 7/1/2004-12/31/2021. Demographic and clinical variables were assessed. Patients were classified as overweight (BMI≥85-
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 4134630: Focal Delivery of Antiplatelet Therapy to Prevent Post-Stent Bleeding in High-Risk Patients
Circulation, Volume 150, Issue Suppl_1, Page A4134630-A4134630, November 12, 2024. Background:Over 3 million percutaneous coronary interventions (PCI) are performed yearly to treat coronary artery stenosis. Stent thrombosis is a catastrophic complication associated with high morbidity and mortality, and its prevention requires the use of prolonged dual antiplatelet therapy (DAPT), which increases bleeding risk. Within the first 30 days after PCI, the mortality of DAPT-associated major bleeding is on par with recurrent myocardial infarction.Research question:No stent system that provides focal antiplatelet activity to prevent stent thrombosis exists, eliminating the need for systemic DAPT and subsequent bleeding risk.Aim:To address this unmet need, we have developed such a stent, termed “the ticagrelor coated stent” (TCS).Methods:Self-assembled monolayers (SAMs) of 12-aminododecylphosphonic acid (ADPA) were formed on cobalt-chromium stents. The amine tail group of ADPA was used to link the ticagrelor molecule through a Mitsunobu reaction and confirmed via infrared spectroscopy. Coating uniformity was validated via atomic force microscopy. In an ex-vivo porcine arterio-venous fistula model, the ticagrelor-coated stents (TCS) were placed in alternating series adjacent to uncoated bare metal stents (BMS). Similarly, TCS and everolimus-eluting stents were placed in the porcine left circumflex arteries for acute (7 days) and chronic (35 days) studies.Results:(Figure 1): Grossly, no thrombus was seen on the TCS compared to the BMS. Platelet and micro-thrombi adherence were significantly reduced on TCS. Notably, inflammation, measured by neutrophil and monocyte adherence, was also reduced by approximately 10-fold on the TCS vs the BMS. Angiography, optical coherence tomography (OCT), and histopathology results show the TCS widely patent without systemic DAPT.Conclusion:These findings show that TCS prevents stent thrombosis through focal anti-platelet action and may reduce the bleeding risk associated with prolonged use of systemic DAPT. Long-term safety and efficacy studies are underway.
Abstract Su1206: Reduced Time to Goal Therapeutic Hypothermia With Implementation of a Post Cardiac Arrest Consult Service
Circulation, Volume 150, Issue Suppl_1, Page ASu1206-ASu1206, November 12, 2024. Introduction:Critical care after advanced cardiac life support can be pivotal for survival and outcomes in patients with out-of-hospital cardiac arrest (OHCA). Prior studies have demonstrated improvements in survival after OHCA with shorter door-to-therapeutic hypothermia (TH) initiation times. Post-cardiac arrest consult teams (PCACT) can facilitate TH to goal 33°C and other aspects of post-arrest care. However, the effects of such a service on TH have not been consistently quantified.Hypothesis:More OHCA patients would undergo TH and reach goal temperature sooner following implementation of a PCACT.Aims:We aim to evaluate the effectiveness of a PCACT in optimizing TH in survivors of OHCA.Methods:We conducted a retrospective chart review of 305 patients admitted between January 1, 2021 and December 31, 2022. Implementation of a dedicated PCACT, comprised of a neurointensivist and an advanced practice provider or neurocritical care fellow, occurred on January 1, 2022. The PCACT was active on weekdays only. One year before and after this date were designated as “pre-PCACT” and “post-PCACT”, respectively. De-identified patient demographics, clinical features of cardiac arrest, and TH data were collected and compared using Wilcoxon rank-sum and Chi-squared tests for continuous and categorical variables, respectively.Results:Of the 305 patients admitted during the study period, 149 were in the pre-PCACT group and 156 were in the post-PCACT group. Baseline demographics between the two groups were similar except that the post-PCACT group had more patients with non-shockable rhythms (64% vs. 54%,p=0.001). Patients were not cooled to 33°C more frequently (50 vs. 52%) pre- or post-PCACT. TH to 33°C was performed in 156 (51%) patients, 78 patients (50%) pre- and post-PCACT implementation. There were no baseline demographic or temperature differences between the two groups amongst patients undergoing TH to 33°C. Post-PCACT patients were quicker to reach 33°C (1.6 vs. 3 hours,p=0.001). After PCACT implementation, this difference was noted during weekdays but not during weekends (1.3 vs. 2.7 hours,p=0.05).There were no differences in survival or neurologic outcomes pre- and post-PCACT introduction, nor between patients who were or were not cooled to 33C.Conclusion(s):Implementation of a PCACT may streamline care to reduce time to goal temperature during TH. However, further study is required to determine whether a PCACT can improve outcomes.
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.
Pancreatite acuta: diagnosi, valutazione di gravità, terapia medica ed endoscopica e gestione del post-acuzie
Evaluation of occupational therapy in persons with COVID-19: a pre-post observational cohort study
Background
Persons with COVID-19 may experience limitations in daily functioning and can be referred to occupational therapy.
Objectives
To evaluate changes in daily functioning, cognitive complaints, fatigue and self-management of persons with COVID-19 who received occupational therapy in primary care.
To get insights in the volume and duration of occupational therapy.
Design
A pre-post observational cohort study from October 2020 until April 2021.
Setting
Fifty-eight occupational therapy practices in primary care throughout the Netherlands participated with 68 occupational therapists.
Participants
228 adults (≥18 years) with COVID-19, referred to occupational therapy, gave informed consent and participated in the pre-post evaluation. The mean age was 49 years (SD 13) and 79% of the patients was female. The most frequently reported complaints included fatigue and cognitive complaints.
Interventions
Occupational therapy using Dutch guidelines for occupational therapy in clients with COVID-19.
Outcome measures
Performance and satisfaction with performance using the Canadian Occupational Performance Measure (COPM); the impact of Cognitive Complaints on Participation (CoCo-P); and daily activities, self-management and perceived contribution of occupational therapy using the Patient Reported Outcome Measure for Occupational Therapy (PROM-OT).
Results
COPM-performance score improved with a mean difference of 2.9 points (95% CI 2.7 to 3.2), and COPM-satisfaction score improved with 3.2 points (95% CI 2.9 to 3.5). CoCo-P score improved with a mean difference of 20.9 points (95% CI from 14.4 to 27.4), and PROM-OT improved with 42.8 points (95% CI from 40.2 to 45.4). Participants received a median of seven sessions of occupational therapy (IQR 5–10) with a median duration of 18 weeks (IQR 12–25). They valued the contribution of occupational therapy to their improved functioning with a mean score of 8 (SD 1.4) and recommended this to others with a mean score of 9 (SD 1.2).
Conclusions
Persons with COVID-19 who received occupational therapy in primary care improved significantly in daily functioning and highly valued occupational therapy.
Association between sarcopenia index, intraoperative events and post-discharge mortality in patients undergoing percutaneous coronary intervention: a retrospective cohort study in a teaching hospital in Western China
Objectives
To examine the association between the sarcopenia index (SI) and the risk of intraprocedural events and post-discharge death during percutaneous coronary intervention (PCI).
Design
A retrospective cohort study.
Setting
The study was conducted at a teaching hospital in Western China.
Participants
The participants were patients aged 45 years and older who underwent PCI at the hospital and had an estimated glomerular filtration rate (eGFR) of ≥15 mL/min/1.73 m2. Patients who died during hospitalisation, as well as those with unknown death dates, those lost to follow-up and those with missing information for the SI calculation, were excluded.
Primary and secondary outcome measures
The SI was calculated as serum creatinine/cystatin C (Cr/CysC) x 100. The high-SI group was defined as the highest quartile, while the remaining participants were included in the low-SI group. Intraprocedural events included intraprocedural coronary slow flow (CSF)/coronary artery no-reflow (CNR) and malignant ventricular arrhythmia (MVA). In the event of death, the date of death was recorded.
Results
The study included 497 patients who underwent PCI in our hospital, of whom 369 (74.25%) were males. A total of 57 (11.47%) patients developed CSF, 100 (20.12%) developed CNR and 4 (0.8%) developed MVA. Forty-four (8.85%) patients died post-discharge. The proportion of patients in the low-SI group who developed CSF was higher than those who did not (16.94% vs 9.65%, p=0.027). In addition, the average SI was lower in patients who developed CSF than in those who did not (81.99 vs 87.11, p=0.043). After adjusting for possible confounding factors, logistic regression analysis showed that the risk of CSF in the low-SI group was higher than that in the high-SI group (OR = 2.01, 95% CI: 1.04 to 3.89). In addition, it was found that the lower the SI, the higher the risk of CSF (OR = 0.983, 95% CI: 0.967 to 0.999).
Conclusions
Patients with lower SI had a greater risk of developing CSF, and the lower the SI, the higher the risk of CSF. However, these data suggest that SI is not associated with CNR and the risk of post-discharge death in patients after PCI.
Contraceptive Access in the US Post- Dobbs
This Viewpoint contraceptive justice after the Dobbs v Jackson Women’s Health Organization US Supreme Court decision, which led to a decline in contraceptive access, especially in states with abortion bans.
Transcatheter Repair Versus Surgery for Atrial Versus Ventricular Functional Mitral Regurgitation – a Post-hoc Analysis of the MATTERHORN Trial
Circulation, Ahead of Print.
[Articles] Incidence of post-acute COVID-19 symptoms across healthcare settings in seven countries: an international retrospective cohort study using routinely-collected data
Post-acute COVID-19 symptoms, as listed by the WHO, were commonly observed following COVID-19 infection. However, even after standardising research methods, there was significant heterogeneity in the incidence rates from different healthcare settings and geographical locations. This is the first international study of the epidemiology of post-acute COVID-19 symptoms using the WHO-listed symptoms. Its findings contibute to understand the epidemiology of this condition from a multinational approach.
[Articles] Risk factors associated with post-tuberculosis sequelae: a systematic review and meta-analysis
This systematic review and meta-analysis found that long-term physical post-TB sequelae including respiratory, hepatic, and hearing impairment were associated with a range of socio-demographic, behavioral, and clinical factors. Identification of these risk factors will help to identify patients who will benefit from interventions to reduce the burden of suffering from post-TB treatment.
Longitudinal changes in self-reported medication adherence and beliefs about post-stroke medicines in Sweden: a repeated cross-sectional study
Objectives
To explore changes in beliefs about medicines and self-reported medication non-adherence between 3 and 24 months after stroke and to investigate associations between beliefs about medicines and non-adherence at 24 months after stroke.
Design
Longitudinal questionnaire survey.
Setting
Patients treated for acute stroke in 25 Swedish hospitals.
Participants
Only patients living at home were included. Of the 594 individuals who answered the 3 month questionnaire, 401 were included at 24 months; among the remainder, 34 (5.7%) had died, 149 (25,1%) did not respond or had incomplete information on adherence and 10 (1.7%) were not living at home.
Measures
The primary outcome was self-reported medication adherence as measured with the Medication Adherence Report Scale (MARS). The Beliefs about Medicines Questionnaires (BMQ) was used to assess personal beliefs about medicines. Background and clinical data were included from the Swedish national stroke register.
Results
According to dichotomised MARS sum scores, more individuals were classified as non-adherent at 24 months after stroke (n=63, 15.7%) than at 3 months after stroke (n=45, 11.2%) (p=0.030). For BMQ, the only difference over time was an increase in the Necessity subscale (p=0.007). At 24 months, in comparison to adherent patients, non-adherent patients scored statistically significant higher on negative beliefs about medicines, such as Concern (OR 1.17, 95% CI: 1.09 to 1.25), Overuse (OR: 1.37, 95% CI: 1.21 to 1.54) and Harm (OR: 1.24, 95% CI: 1.11 to 1.39), and lower on positive beliefs about medicines, namely, Necessity (OR: 0.88, 95% CI: 0.80 to 0.96) and Benefit (OR: 0.85, 95% CI: 0.74 to 0.98).
Conclusions
Stroke patients‘ beliefs about medicines were associated with adherence, and over time beliefs remained stable across all domains, except for an increased perception of medications as being necessary. Despite this, more patients became non-adherent over time. To counteract non-adherence, interventions targeted to improve intentional adherence as well as non-intentional adherence should be investigated and implemented.