Future Adverse Events Research Articles

Can Erectile Dysfunction Severity Predict Major Adverse Cardiovascular Events in Men Undergoing Dialysis? A Prospective Cohort Study.

To evaluate the impact of severe erectile dysfunction (ED) on future major adverse cardiovascular events (MACE) in men on dialysis. This prospective cohort study included 71 men on dialysis. ED was assessed using the Sexual Health Inventory for Men (SHIM). Men were divided into the mild/moderate ED (SHIM score ≥8) and severe ED (SHIM score ≤7) groups. The primary endpoint was MACE-free survival. MACE was a composite of myocardial infarction, cardiovascular death, and stroke. The secondary endpoints were cardiac event-free survival and overall survival (OS). Moreover, the predictive abilities of severe ED for 5-year MACE, 5-year cardiac events, and 5-year overall mortality were evaluated. The median age and follow-up period of the included men were 64 years and 58 months, respectively. The median SHIM score was 4.0; all had a degree of ED, and 64.7% had severe ED. In the background-adjusted multivariable analyses, severe ED was not significantly associated with shorter MACE-free survival (hazard ratio [HR], 1.890; 95% confidence interval [CI], 0.533-6.706; p=0.324), cardiac event-free survival (HR, 2.081; 95% CI, 0.687-6.304; p=0.195), and OS (HR, 0.817; 95% CI, 0.358-1.863; p=0.630). Severe ED did not significantly improve the predictive abilities for 5-year MACE, 5-year cardiac events, and 5-year overall mortality (p=0.110, p=0.101, and p=0.740, respectively). ED severity was not associated with shorter MACE-free survival, cardiac event-free survival, or OS, and ED severity could not improve the predictive abilities for these outcomes in men undergoing dialysis.

Early-stage non-alcoholic fatty liver disease in relation to atherosclerosis and inflammation

Background and aimsNon-alcoholic fatty liver disease (NAFLD) is a multisystem disease closely linked to cardiovascular disease (CVD). This study aims to investigate the connection between early-stage NAFLD and atherosclerosis, as well as the correlation between liver fibrosis and coronary heart disease while exploring underlying inflammatory mechanisms. MethodsIn this retrospective study, the authors analyzed data from 607 patients who underwent both coronary computed tomography angiography (CCTA) and abdominal ultrasonography (US). Logistic regression was utilized to examine the association between NAFLD and atherosclerosis, while mediation analysis was conducted to explore whether inflammatory markers mediate the link between liver fibrosis and coronary artery disease. ResultsAmong the 607 patients included, 237 (39.0 %) were diagnosed with NAFLD through ultrasonography. After adjusting for traditional cardiovascular risk factors, ALT, and AST, NAFLD demonstrated a significant correlation with carotid intimal thickening (1.58, 95 % CI 1.04‒2.40; p = 0.034) and non-calcified plaque (1.56, 95 % CI 1.03‒2.37; p = 0.038). Additionally, fibrosis predictive markers, including FIB-4 > 1.3 (1.06, 95 % CI 2.30‒5.00; p = 0.035) and APRI (6.26, 95 % CI 1.03‒37.05; p = 0.046), independently correlated with coronary heart disease after adjusting for cardiovascular risk factors. Conversely, among systemic inflammatory markers, only the neutrophil-to-lymphocyte ratio (NLR) and systemic inflammatory response index (SIRI) are independently associated with coronary heart disease. ROC curve analysis indicated that combining predictive fibrosis markers or inflammatory markers with traditional cardiovascular risk factors enhanced the predictive accuracy for coronary heart disease. Mediation analysis revealed that NLR fully mediated the effect of liver fibrosis on coronary heart disease. ConclusionNAFLD is associated with carotid intimal thickening and non-calcified plaque, suggesting an increased cardiovascular risk. Furthermore, liver fibrosis independently increases the risk of coronary heart disease in the early-stage NAFLD population, and inflammation may play a fully mediating role in the effect of liver fibrosis on coronary heart disease. Early intervention is crucial for NAFLD patients to mitigate future major adverse cardiovascular events.

Clinical outcomes of obstructive colorectal cancer patients during the coronavirus disease 2019 pandemic.

The coronavirus disease 2019 (COVID-19) pandemic has affected all aspects of clinical care including diagnosis and treatment of colorectal cancers (CRCs) globally, including in Türkiye. During the initial peak of the pandemic, elective surgeries and outpatient clinics were restricted in addition to the government-imposed lockdown, resulting in a decrease in the number of colonoscopies being performed and patients admitted to inpatient wards for treatment of CRCs. In this study, we aimed to investigate whether the pandemic has affected presentation characteristics and outcomes of obstructive colorectal cancer in this period. This is a single-center, retrospective cohort study based on all CRC adenocarcinoma patients that underwent surgical resection in a high-volume tertiary referral center in Istanbul, Türkiye. Patients were divided into two groups before and after 15 months of identification of 'patient-zero' in Türkiye (March 18, 2020). Patient demographics, initial presentation characteristics, clin-ical outcomes, and pathological cancer stages were compared. Overall, 215 patients underwent resection for CRC adenocarcinoma during 30 months (COVID era: 107, pre-COVID era: 108). Patient characteristics, tumor location, and clinical staging were comparable between two groups. During the COVID period, the number of obstructive CRCs (P<0.01) and emergency presentations (P<0.01) increased significantly compared to the respective pre-COVID period. However, there were no differences between 30-day morbidity, mortality, and pathological outcomes (P>0.05). Although the results of our study indicate a significant increase in emergency presentation and a decrease in elective admissions of CRCs during the pandemic, patients treated during the COVID period were not at a significant disadvantage in terms of post-operative outcomes. Further efforts should be made to decrease risks related to an emergency presentation of CRCs for future adverse events.

Use of an Agitation Measure to Screen for Suicide and Self-Harm Risk Among Emergency Department Patients.

Suicidality alone is insensitive to suicide risk among emergency department (ED) patients. We describe the performance of adding an objective assessment of agitation to a suicide screening instrument for predicting suicide and self-harm after an ED encounter. We tested the performance of a novel screener combining the presence of suicidality or agitation for predicting suicide within 90 days or a repeat ED visit for self-harm within 30 days using retrospective data from all patients seen in an urban safety net ED over 27 months. Patients were assessed for suicidality using the Columbia-Suicide Severity Rating Scale-Clinical Practice Screener and for agitation using either the Behavioral Activity Rating Scale or Richmond Agitation Sedation Scale. We hypothesized that a screener based on the presence of either suicidality or agitation would be more sensitive to suicide risk than the Columbia-Suicide Severity Rating Scale-Clinical Practice Screener alone. The screener's performance is described, and multivariable regression evaluates the correlations between screening and outcomes. The sample comprised 16,467 patients seen in the ED who had available suicide screening and agitation data. Thirteen patients (0.08%) died by suicide within 90 days after ED discharge. The sensitivity and specificity of the screener combining suicidality and agitation for predicting suicide was 0.69 (95% confidence interval, 0.44-0.94) and 0.74 (0.44-0.94), respectively. The sensitivity and specificity for agitation combined with positive suicide screening for self-harm within 30 days were 0.95 (0.89-1.00) and 0.73 (0.73-0.74). For both outcomes, augmenting the Columbia-Suicide Severity Rating Scale-Clinical Practice Screener with a measure of agitation improved both sensitivity and overall performance compared to historical performance of the Columbia-Suicide Severity Rating Scale-Clinical Practice Screener alone. Combining a brief objective measure of agitation with a common suicide screening instrument improved sensitivity and predictive performance for suicide and self-harm risk after ED discharge. These findings speak to the importance of assessing agitation not only for imminent safety risk during the patient encounter but also for reducing the likelihood of future adverse events. This work can improve the detection and management of suicide risk in emergency settings.

Organisational Resilience during COVID-19 Times: A Bibliometric Literature Review

Since the start of the pandemic, organisations have recognised the importance of resilience strategies and they have been trying to enhance them for future crises. COVID-19 has profoundly affected the way that organisations operate and react to recent events. The lessons from this pandemic for future adverse events are yet to be understood. This study aims to identify the most prominent issues and gaps in the literature regarding organisational resilience in the context of COVID-19. To achieve this, this paper is conducting a bibliometric literature review of 185 articles discussing organisational resilience during the COVID-19 pandemic, from 2019 to the beginning of 2022. This paper identifies six main topic clusters: (1) entrepreneurial, tourism, and emergency responses; (2) world environment, disruptions, and organisations; (3) employees and mediation; (4) firms and opportunities; (5) capabilities and digitalisation; and (6) leadership during uncertain times. The main contribution of this study is an up-to-date identification of research concerning organisational resilience in times of crisis, particularly research conducted during the COVID-19 pandemic. As COVID-19 is a unique crisis, this pandemic, as well as the timely results of this paper, stand out. In light of this, I believe one can develop innovative, fundamental new directions for resilience literature in the future.

Erectile Dysfunction: Pharmacological Pathways with Understudied Potentials.

Erectile dysfunction (ED) is a public health concern worldwide. In the past, it was perceived as a phenomenon attributed to age advancement. However, more individuals are affected every year that do not fall under that age criterion. Epidemiological research revealed that this abnormality has an association with endothelial dysfunction connected to several cardiovascular (CV) risk factors. Currently, ED is interpreted as a clinical marker for future adverse events and not only as a present health issue that negatively affects the quality of life. The management of ED involves lifestyle modifications, therapeutic optimization for comorbid conditions, and pharmacological and psychosexual therapy. Phosphodiesterase type 5 (PDE5) inhibitors are the first-line pharmacological agents to be prescribed for such a condition. Nonetheless, other pharmacological pathways and agents remain underinvestigated or were investigated at some stage. This review aimed to present to future researchers interested in this field with some pharmacological agents that showed favorable effects on a limited number of studies on human subjects or experimental models.

Loss of perceived social role, an index of social frailty, is an independent predictor of future adverse events in hospitalized patients with heart failure.

Although the impact of physical frailty on prognosis and the effect of cardiac rehabilitation in HF patients has been well established, data for the prognostic impact of social frailty (SF) in HF patients are limited. In addition, the relative importance of each SF domain in clinical outcomes remains unclear. We aimed to get a new insight into the associations of SF with clinical outcomes in elderly hospitalized HF patients. A single-center, retrospective cohort study was conducted using data from 310 in-hospital HF patients aged ≥ 65 years (mean age of 78 ± 8 years; 49% women). Makizako's five questions, a self-reported questionnaire, were used to define SF. The primary outcome was composite events defined by all-cause death and cardiovascular events. Of the 310 elderly HF patients, 188 patients (61%) had SF. Seventy-five patients (24%) had composite events during a mean follow-up period of 1.93 ± 0.91 years. Kaplan-Meier curves showed that patients with SF had a significantly higher composite event rate than patients without SF. In multivariate Cox regression analyses, SF was independently associated with a higher composite event rate after adjusting for prognostic markers [adjusted hazard ratio (HR), 2.01; 95% confidence interval (CI), 1.07-3.78; p = 0.04]. Of the 5 questions for defining SF, an answer of yes to the question about not feeling helpful toward friends or family, which indicates loss of perceived social role, was an independent predictor of composite events (adjusted HR, 2.28; 95% CI, 1.36-3.82; p < 0.01). Inclusion of loss of perceived social role into the baseline prognostic model improved both the continuous net reclassification improvement (0.562; 95% CI, 0.298-0.827; p < 0.01) and integrated discrimination improvement (0.031; 95% CI, 0.006-0.056; p = 0.02). Loss of perceived social role is associated with increased adverse event risk and provides additive prognostic information in elderly HF patients.

The Prognostic Value of B-Type Natriuretic Peptide in Patients With Cardiac Sarcoidosis Without Heart Failure: Insights From ILLUMINATE-CS.

Background The prognostic role of BNP (B-type natriuretic peptide) in patients with cardiac sarcoidosis without evident heart failure is unknown. Methods and Results This is a post hoc analysis of ILLUMINATE-CS (Illustration of the Management and Prognosis of Japanese Patients With Cardiac Sarcoidosis), a multicenter, retrospective, and observational study that evaluated the clinical characteristics and prognosis of cardiac sarcoidosis. We analyzed patients with cardiac sarcoidosis without evident heart failure at the time of diagnosis. The association between baseline BNP levels and prognosis was investigated. The primary end point was the combined end point of all-cause death, heart failure hospitalization, and fatal ventricular arrhythmia. In total, 238 patients (61.0±11.1 years, 37% men) were analyzed, and 61 primary end points were observed during a median follow-up period of 3.0 (interquartile range, 1.7-5.8) years. Patients with high BNP (BNP above the median value of BNP) were older and had a lower renal function and left ventricular ejection fraction than those with low BNP values. Kaplan-Meier curve analysis indicated that high BNP levels were significantly associated with a high incidence of primary end points (log-rank P=0.004), and this association was retained even in multivariable Cox regression (hazard ratio, 2.06 [95% CI, 1.19-3.55]; P=0.010). Log-transformed BNP as a continuous variable was associated with the primary end point (hazard ratio, 2.12 [95% CI, 1.31-3.43]; P=0.002). Conclusions High baseline BNP level was an independent predictor of future adverse events in patients with cardiac sarcoidosis without heart failure at the time of diagnosis. Registration URL: https://www.umin.ac.jp/english/; Unique Identifier: UMIN-CTR: UMIN000034974.

A State-of-the-Art Review: The Percutaneous Treatment of Highly Calcified Lesions.

Coronary artery calcification is prevalent in coronary heart disease with its progression being predictive of future adverse cardiac events. Its presence is considered to be a marker of interventional procedural complexity. Several adjunctive percutaneous coronary intervention tools, such as modifying balloons, atherectomy devices and intravascular lithotripsy, now exist to successfully treat calcified lesions. In this state-of-the-art review, a step-wise progression of strategies is described to modify coronary plaque, from well-recognised techniques to techniques that should only be considered when standard manoeuvres have proven unsuccessful. Technology has advanced greatly over the past few decades and we discuss how future technologies might shape percutaneous intervention.

Risk of mortality and other adverse outcomes from myocardial infarction in cancer survivors: a meta-analysis.

Myocardial infarction (MI) is an acute cardiovascular disease that can increase prognosis risks such as arrhythmia, heart failure, shock, etc. Studies have found that even well-controlled coexistence of cancer could affect the quality of life in MI patients. However, the prognostic impact of cancer on MI patients is controversial. This meta-analysis aimed to assess the influence of cancer on the risk of future all-cause mortality, cardiovascular mortality, and major adverse cardiovascular and cerebrovascular events (MACCE) in MI patients. The Embase, PubMed, and Cochrane libraries were searched for cohort studies and case-control from inception to May 2022. The quality of the included pieces of literature was assessed using the Newcastle-Ottawa Quality Assessment Scale (NOS). All statistical analyses were performed using Stata statistical software versions 14.0 and 16.0. Sensitivity analysis assessed the robustness of the results, and funnel plots and Egger's tests evaluated the publication bias. A total of 10 studies were included, covering 7,210,530 participants. Summary analyses show that compared with non-cancer patients, cancer increased the risk of long-term all-cause mortality in MI patients (HR 1.58, 95% CI 1.36-1.84, I2 = 94.2%). However, no significant difference was observed in the risk of cardiovascular mortality (HR 1.18, 95% CI 0.91-1.54, I2 = 52.4%) or MACCE (HR 1.26, 95% CI 0.94-1.70, I2 = 99.2%). In subgroup analysis, cancer was associated with the risk of recurrent MI (HR 1.18, 95% CI 1.03-1.34, I2 = 88.8%), and major bleeding (HR 2.01, 95% CI 1.60-2.52, I2 = 93.1%), with no significant difference in the risk of stroke (HR 1.11, 95% CI 0.97-1.27, I2 = 85.1%). This meta-analysis shows that cancer increases the risk of all-cause mortality, recurrent MI, and major bleeding in MI patients but is not associated with the risk of cardiovascular death. Therefore, comprehensive multidisciplinary management and monitoring of potential future adverse events in MI patients with cancer are needed. The meta-analysis was registered in the International Register of Prospective Systematic Reviews (NO. CRD42022332775).

Cone-beam CT delta-radiomics to predict genitourinary toxicities and international prostate symptom of prostate cancer patients: a pilot study

For prostate cancer (PCa) patients treated with definitive radiotherapy (RT), acute and late RT-related genitourinary (GU) toxicities adversely impact disease-specific quality of life. Early warning of potential RT toxicities can prompt interventions that may prevent or mitigate future adverse events. During intensity modulated RT (IMRT) of PCa, daily cone-beam computed tomography (CBCT) images are used to improve treatment accuracy through image guidance. This work investigated the performance of CBCT-based delta-radiomic features (DRF) models to predict acute and sub-acute International Prostate Symptom Scores (IPSS) and Common Terminology Criteria for Adverse Events (CTCAE) version 5 GU toxicity grades for 50 PCa patients treated with definitive RT. Delta-radiomics models were built using logistic regression, random forest for feature selection, and a 1000 iteration bootstrapping leave one analysis for cross validation. To our knowledge, no prior studies of PCa have used DRF models based on daily CBCT images. AUC of 0.83 for IPSS and greater than 0.7 for CTCAE grades were achieved as early as week 1 of treatment. DRF extracted from CBCT images showed promise for the development of models predictive of RT outcomes. Future studies will include using artificial intelligence and machine learning to expand CBCT sample sizes available for radiomics analysis.

Abstract 14875: Topological Data Analysis of Electronic Health Record Features Predicts Major Cardiovascular Outcomes After Revascularization for Acute Myocardial Infarction

Introduction: Topological data analysis (TDA) is an emerging mathematical technique that imposes structure on a dataset and examines the shapes (or topological features) that arise. The TDA algorithm Mapper Plus is proposed to study the spatial characteristics of clinical data for the purpose of patient classification. This is a data-driven and hypothesis-free approach to clinical risk stratification. Hypothesis: The hypothesis is that Mapper Plus can classify distinctive subsets of patients receiving optimal treatments post-acute myocardial infarction (AMI). Our goal is to identify subgroups who remained at risk of having a future adverse event (AE) i.e., death, heart failure hospitalization, or recurrent MI Methods: A single-center, retrospective analysis of 31 clinical variables from the electronic health record (EHR) was conducted on 798 AMI subjects. Risk was defined as high or low in relation to the average probability of survival without AE for the entire cohort at the 1 year mark. Results: TDA identified six subsets of patients. Four subsets (n=597) had &gt; 1-fold change on the probability of survival free of AEs; these became the low-risk subgroup. Two subsets (n=344) had &lt; 1-fold change on the probability of survival free of AEs; these became the high-risk subgroup. Because Mapper Plus allows for subject overlap across subgroups, 143 subject (18%) were shared between the high (n=201, 25%)- and low-risk (n=454, 57%) subgroups and were extracted into a 3rd intermediate risk subgroup (see figure). Conclusions: TDA significantly stratified AMI patients into 3 subgroups with distinctive incidences of AE up to 3 years post AMI. This is a new framework for EHR-based risk stratification that requires no additional patient interaction, is agnostic to prior knowledge, and is driven by the topological features of the included data. Further studies will be needed to validate TDA across different patient cohorts before it can be applied to clinical practice.

Abstract 13084: Clinical Outcomes and Factors for Adverse Events in Patients With Severe Coronary Calcification Assessed by Optical Coherence Tomography

Introduction: Severe coronary calcification is a known factor for worse clinical and angiographic outcomes after percutaneous coronary intervention (PCI). However, the association between lesion characteristics and post-stent findings and worse clinical outcomes in patients with severely calcified lesions remains to be elucidated. Hypothesis: Among patients with severely calcified lesions, pre and post stent findings assessed by optical coherence tomography (OCT) are associated with future adverse events. Methods: A total of 241 consecutive patients with severely calcified lesions, who underwent OCT imaging of the culprit lesion were included. Severely calcified lesion was defined as a lesion with a maximum calcium angle &gt;180°, maximum thickness &gt;0.5 mm and calcium length &gt;5 mm, which were assessed by OCT. The device-oriented clinical endpoint (DoCE) was defined as a composite of cardiac death, target vessel-related myocardial infarction, ischemia-driven target lesion revascularization, and stent thrombosis. Results: The presence of eruptive calcified nodule (eCN) (41% vs. 18%, p =0.003) in the culprit lesion and medial dissection with calcified flaps (59% vs. 26%, p &lt;0.001) after stenting was significantly higher in patients with DoCE than in those without. Among the four groups classified by the presence of eCN and medial dissection with calcified flap, incidence of DoCE was the highest in lesions with both eCN and medial dissection with calcified flap ( p &lt;0.001) (Figure). Conclusions: An increased incidence of DoCE was demonstrated in lesions with the combined presence of eCN and medial dissection with calcified flap. The present results may explain the importance of the careful assessment of severely calcified lesions using OCT for the risk stratification of future adverse events.

Abstract 12824: Predictive Value of Artificial Intelligence-Enabled Electrocardiography in Patients with Takotsubo Cardiomyopathy

Introduction: Recent studies have indicated high rates of future major adverse cardiovascular events in patients with Takotsubo cardiomyopathy (TTC). This study sought to evaluate the prognostic value of our institutional artificial intelligence-augmented electrocardiography (AI-ECG) algorithms in patients with TTC. Methods: This study enrolled consecutive patients in the prospective and observational Mayo Clinic Takotsubo syndrome registry. TTC was diagnosed according to the Mayo Clinic diagnostic. Our clinic’s previously developed and validated AI-ECG algorithms were used for detection of ECG-Age, probability of low ejection fraction, and probability of atrial fibrillation.Multivariable models were constructed to evaluate the association of AI-ECG and other clinical characteristics with major adverse cardiac events (MACE), defined as cardiac death, recurrence of TTC, nonfatal myocardial infarction, hospitalization for congestive heart failure, and stroke. Results: In the final analysis, 305 patients were studied over a median follow-up of 4.8 years. Patients with MACE were more likely to be older, have history of hypertension and chronic heart failure (CHF), worse renal function as well as having high-risk AI-ECG findings compared to those without. In the multivariate Cox proportional hazard analysis, the presence of 3 or 4 high-risk findings detected by AI-ECG, remained a significant predictor of MACE in the patients with TTC after adjusted by conventional risk factors (hazard ratio (HR) 2.17, 95% CI [1.33, 3.53], P=0.002; HR 2.44, 95% CI [1.38, 4.29], P=0.002, respectively). Conclusions: The combined use of developed AI-ECG algorithms derived from a single 12-lead ECG might identify ECG correlates of underlying non-transient myocardial dysfunction and detect subtle underlying patterns associated with worse outcomes in patients with TTC. This approach might be beneficial for stratifying high-risk patients with TTC.

Morphological characteristics of lesions with thin cap fibroatheroma-a substudy from the COMBINE (OCT-FFR) trial.

To study if any qualitative or quantitative optical coherence tomography (OCT) variables in combination with thin cap fibroatheroma (TCFA) patients could improve the identification of lesions at risk for future major adverse cardiac events (MACEs). From the combined optical coherence tomography morphologic and fractional flow reserve hemodynamic assessment of non- culprit lesions to better predict adverse event outcomes in diabetes mellitus patients: COMBINE (OCT-FFR) trial database (NCT02989740), we performed a detailed assessment OCT qualitative and quantitative variables in TCFA carrying diabetes mellitus (DM) patients with vs. without MACE during follow-up. MACEs were defined as a composite of cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization, and hospitalization for unstable angina. From the 390 fractional flow reserve (FFR)-negative DM patients, 98 (25.2%) had ≥1 OCT-detected TCFA, of which 13 (13.3%) had MACE and 85 (86.7%) were event-free (non-MACE). The baseline characteristics were similar between both groups; however, a smaller minimal lumen area (MLA) and lower mean FFR value were observed in MACE group (1.80 vs. 2.50 mm2, P = 0.01, and 0.85 vs. 0.89, P = 0.02, respectively). Prevalence of healed plaque (HP) was higher in the MACE group (53.85 vs. 21.18%, P = 0.01). TCFA were predominantly located proximal to the MLA. TCFA area was smaller in the MACE group, while no difference was observed regarding the lesion area. Within TCFA carrying patients, a smaller MLA, lower FFR values, and TCFA location adjacent to a HP were associated with future MACE. Carpet-like measured lesion area surface was similar, while the TCFA area was smaller in the MACE arm, and predominantly located proximal to the MLA.

Incremental prognostic value of myocardial strain over ventricular volume in patients with repaired tetralogy of Fallot.

The relative incremental predictive value of myocardial deformation over ventricular volume for future adverse events in patients with repaired tetralogy of Fallot (rTOF) remains unknown. We aimed to determine the incremental prognostic value of myocardial deformation over ventricular volume to predict adverse events in patients with rToF. We retrospectively included patients with rTOF who completed cardiac magnetic resonance (CMR) and follow-up in our hospital from January 2014 to October 2020, and stratified according to the presence or absence of adverse events during follow-up. The strain parameters of the right ventricular (RV) and left ventricular (LV) were obtained from CMR-derived feature tracking. Multivariable Cox proportional hazard models and net reclassification improvement analysis were used to analyze the prognostic information of biventricular strain and volume parameters in rTOF patients. Among 98 patients with rTOF, 54 (55.1%) experienced primary and/or secondary events during a median follow-up period of 27.0 months. Univariable analysis indicated that RV volume and strain were significantly associated with both primary events and all adverse events (all p < .01). Multivariable Cox regression and net reclassification improvement analyses achieved incremental global χ2 (all p < .001), C index (all p < .001), and overall correct reclassification by sequentially adding CMR-derived RV volume, RV strain and LV strain parameters to preexisting clinical factors in adverse events model analyses. RV and LV myocardial deformation provided incremental prognostic information and significant improvement for risk stratification over RV size and clinical variables and therefore can be combined to further enhance prognostication. • RV volume and strain were significantly associated with both primary events and all adverse events, whereas LV volume and strain were associated with primary events. • Ventricular myocardial deformation is a strong predictor of adverse outcomes of patients with repaired tetralogy of Fallot, providing increased prognostic information and significantly improved risk stratification over ventricular size.

Impact of vaccine pause due to Thrombosis with thrombocytopenia syndrome (TTS) following vaccination with the Ad26.COV2.S vaccine manufactured by Janssen/Johnson & Johnson on vaccine hesitancy and acceptance among the unvaccinated population.

BackgroundIn response to reports of thrombosis with thrombocytopenia syndrome (TTS) post-vaccination, the Johnson & Johnson (J&J) vaccine was paused and then restarted in April 2021. Our objective was to assess whether this pause adversely impacted vaccine confidence.MethodsTwo large internet-based surveys were conducted in the US among adults to measure knowledge, attitudes and perceptions of the J&J vaccine pause and rates of vaccine hesitancy among unvaccinated persons before, during and after the pause.ResultsAmong 66% of respondents aware of the pause, 44% identified blood clots as the reason for the pause without prompting. The impact of the pause on vaccine behavior among unvaccinated persons and perception of the vaccine safety system was mixed and modified by trust in the public health authorities. Those who were less willing to get vaccinated because of the pause were less inclined for all vaccines, not only the J&J product. Moreover, a notable proportion (22.1%) of the small number of persons (n = 30) vaccinated with the J&J vaccine after the pause reported not receiving information about the risk of TTS. The proportion of unvaccinated persons who were hesitant was increasing before and during the pause and then leveled off after the pause.ConclusionsThe J&J vaccine pause is unlikely to be a major barrier to vaccine uptake. Public attitudes about vaccines may be more resilient than appreciated, especially when safety issues are investigated with transparent communication. This paper has important implications for messaging and program administration with future vaccine-specific adverse events. Efforts may be warranted to ensure all persons being offered the J&J vaccine are made aware of the risk of TTS.

Pericoronary adipose tissue attenuation index (FAI) and its cardiovascular diagnostic and prognostic utility: a systematic review and meta-analysis

Abstract Background Pericoronary fat attenuation index (FAI) on coronary computed tomography angiography (CCTA) imaging has been proposed as a novel marker of coronary vascular inflammation with prognostic value for major cardiovascular events. To date though there is no systematic review of the published literature and no meta-analyzed data of previously published results. Methods We performed a systematic review and meta-analysis according to the PRISMA guidelines. We systematically explored published literature in MEDLINE (PubMed) before January 20, 2022 for studies assessing FAI in both diagnostic and prognostic clinical settings in patients with or without cardiovascular disease. The primary outcome was the mean difference in FAI attenuation between stable and unstable coronary plaques. The secondary outcome was the hazard ratio of high FAI values for future cardiovascular events. We calculated I2 to test heterogeneity. We used random-effects modelling for the meta-analyses to assess the primary and secondary outcomes. This study is registered with PROSPERO (CRD42021229491). Results In total, 20 studies referred in a total of 7,797 patients were included in this systematic review while 9 studies were used for the meta-analysis. FAI was significantly higher in unstable compared to stable plaques with a mean difference of 4.50 HU (95% CI: 1.10–7.89, I2=88%) among 902 patients. Higher pericoronary FAI values offered incremental prognostic value for major adverse cardiovascular events in studies with prospective follow-up (HR=3.29, 95% CI: 1.88–5.76, I2=75%) among 6,335 patients. Conclusion FAI is a promising imaging biomarker that may be successfully be used for detection of coronary inflammation, discrimination between stable and unstable plaques, and prognosis of future major adverse cardiovascular events. There is an undeniable need for further studies to establish the utility of this biomarker in clinical practice to improve coronary plaque discrimination and cardiovascular risk prognostication. Funding Acknowledgement Type of funding sources: None.

Association of serum MMP9 with adverse features of plaque progression in patients with chronic coronary syndrome (CCS)

Abstract Background Previous studies have demonstrated that MMP-9 may be a predictor of atherosclerotic plaque instability and future adverse cardiovascular events, but longitudinal data on the association between MMP9 and coronary disease progression are lacking. Purpose This study is aimed at investigating whether MMP9 is associated with atherosclerotic plaque progression. Methods MMP9 serum levels were measured in stable patients with chronic coronary syndrome (CCS) undergoing coronary computed tomography angiography at baseline and after a period of 6.5±1.1 years of follow up to assess progression of Total, Fibrous, Fibro-fatty, Necrotic Core, and Dense Calcium plaque volume (PV). The relationship of serum MMP9 with plaque progression was assessed using linear regression analysis, adjusting for clinical variables including, age, sex, risk factors, medical therapy, LDL-C, TG/HDL-C ratio, hs-CRP, and the presence of obstructive CAD (&amp;gt;50% coronary stenosis in at least one major coronary vessels). Results A total of 157 patients (58±8 years of age; 66% males) were included in the analysis, with median MMP9 values of 135±186 mg/dL (mean ± SD). Annual changes of Total, Fibrous-Fatty and Necrotic Core PV were significantly different across MMP9 tertiles (Figure 1). Multivariable linear regression analysis demonstrated a positive association between serum levels of MMP9 and annual change of Total and Necrotic Core PV (Figure 1). Conclusion Among patients with CCS, MMP9 serum levels were an independent predictor of progression of coronary plaque burden and, in particular, of adverse plaque features, such as Necrotic Core PV. This association was robust and independent from baseline traditional cardiovascular risk factors and medications, supporting for MMP9 a role as a novel marker of residual coronary risk. Funding Acknowledgement Type of funding sources: Public grant(s) – EU funding. Main funding source(s): Horizon 2020 - Project “Simulation Modeling of coronary ARTery disease: a tool for clinical decision support–SMARTool”

Diagnosis of coronary layered plaque by deep learning

Abstract Background/Introduction Healed coronary plaques, morphologically characterized by a layered pattern, are signatures of previous plaque disruption and healing. Recent optical coherence tomography (OCT) studies showed that layered plaque is associated with vascular vulnerability and rapid plaque progression. However, the diagnosis of layered plaque requires expertise in OCT image interpretation and is susceptible to interobserver variability. Purpose We aimed to develop a deep learning (DL) model for an accurate diagnosis of layered plaque. Methods We developed a Visual Transformer (ViT)-based DL model emulating the cardiologists who review consecutive OCT frames to make a diagnosis (Figure 1), and compared it to the standard convolutional neural network (CNN) model. We used 302,415 cross-sectional OCT images from 873 patients collected from 9 sites: 237,021 images from 581 patients for training and internal validation from 8 sites, and 65394 images from 292 patients collected from another site for external validation. Results Model performances were evaluated using the area under the receiver operating characteristics (AUC). In the five-fold cross validation, the ViT-based model showed better performance than the standard CNN-based model with AUC of 0.886 (95% confidence interval [CI], 0.882–0.891) compared with 0.797 (95% CI, 0.790–0.804). The ViT-based model also outperformed the standard CNN-based model in the external validation, with an AUC of 0.857 (95% CI, 0.849–0.864) compared to 0.806 (95% CI, 0.797–0.815) (Figure 2). Conclusion(s) The ViT-based DL model will help cardiologists to make an accurate diagnosis of layered plaque, which might help to stratify the risk of future adverse cardiac events. Funding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Mrs. Gillian Gray through the Allan Gray Fellowship Fund in Cardiology