Rate Of Events In Patients Research Articles

Evaluation of Risk Scores as Predictive Tools for Stroke in Patients with Retinal Artery Occlusion: A Danish Nationwide Cohort Study.

Purpose We investigated the 1-year risk of stroke in patients with retinal artery occlusion and evaluated the predictive and discriminating abilities of contemporary risk stratification models for embolic stroke. Methods This register-based cohort study included 7,906 patients with retinal artery occlusion from Danish nationwide patient registries between 1995 and 2018. The study population was stratified according to the number of points obtained in the stroke risk scores: the CHA 2 DS 2 -VASc score and the ESSEN Stroke Risk score. The 1-year risk of stroke within strata was evaluated and compared using the cox proportional hazards model. Furthermore, the discrimination of the risk scores as predictive tools for stroke risk assessment was investigated using C-statistics, Brier score, and the index of prediction accuracy. Results The stroke event rate in patients with retinal artery occlusion increased as the score increased for both risk scores, ranging from 3.62 (95% confidence interval [CI]: 2.46-5.31) per 100 person-years to 13.25 (95% CI: 11.78--14.89) per 100-person-years for increasing levels of the CHA 2 DS 2 -VASc score and from 3.97 (95% CI: 2.97-5.32) per 100 person-years to 16.43 (95% CI: 14.01-19.27) per 100 person-years for increasing levels of the ESSEN Stroke Risk score. Using a risk score of 0 as a reference, the difference was statistically significant for retinal artery occlusion patients with a CHA 2 DS 2 -VASc score of 2 or above and for all levels of the ESSEN Stroke Risk score. The C-statistics for the risk scores was 61% (95% CI: 58%-63%) and 62% (95% CI: 59-64%) for the CHA 2 DS 2 -VASc score and ESSEN Stroke Risk score, respectively. Conclusion The results suggested that the use of the CHA 2 DS 2 -VASc score and the ESSEN Stroke Risk score was applicable for risk stratification of stroke in patients with retinal artery occlusion, but discrimination was poor due to low specificity.

Oral fidaxomicin versus vancomycin for the treatment of Clostridioides difficile infection: A systematic review and meta-analysis of randomized controlled trials

BackgroundFidaxomicin (FDX) has received considerable attention as a novel therapeutic alternative agent to vancomycin (VCM) for Clostridioides difficile infection (CDI). However, the superiority and efficacy profile of FDX are not sufficiently determined by high-quality evidence. This study aimed to clarify the superiority of FDX for CDI treatment through a systematic review and meta-analysis. MethodsWe conducted a meta-analysis of randomized controlled trials (RCTs) which evaluated the efficacy and safety of FDX and VCM in patients with CDI. Electronic databases (PubMed, Cochrane Library, Web of Science, and Clinicaltrials.gov) were searched for studies published until October 15, 2021. The primary endpoint was global cure. The secondary endpoints were clinical cure, recurrence, and adverse event. Risk ratios (RRs), risk differences (RDs), and 95% confidence intervals were calculated using Mantel-Haenszel random-effects model. The risk of bias was assessed using Cochrane Handbook for Systematic Reviews of Interventions and Assessment Criteria. ResultsSix RCTs were included in this meta-analysis. Compared to VCM, FDX was associated with significantly higher global cure rates (RR = 1.18, P < 0.00001; RD = 0.11, 95% CI = 0.07–0.16). In addition, clinical cure rates were comparable between FDX and VCM (P = 0.31). FDX was associated with significantly lower recurrence rates compared to VCM (RR = 0.59, P < 0.0001). In addition, adverse event rates were not significantly different between the drugs (P = 0.41). ConclusionFDX achieves significantly higher global cure rates and lower recurrence rates and is comparable to VCM in clinical cure rates and adverse event rates in patients with CDI. Collectively, FDX is superior to VCM as a therapeutic agent for CDI.

Comparison Between Echocardiography and Cardiac Computed Tomography in the Evaluation of Diastolic Dysfunction and Prediction of Heart Failure

Recent data indicate that left atrial (LA) function assessment by cardiac computed tomography (CT) is closely related to diastolic dysfunction (DD). Therefore, we aimed to perform a direct comparison between CT and echocardiography for diagnosis of advanced DD and prediction of future heart failure or cardiovascular death. We identified 340 patients who had both spiral cardiac CT and a proximate echocardiogram. LA total emptying fraction (LATEF), a measure of global LA function, was automatically calculated from CT data, as a surrogate for diastolic function and was compared with echocardiographic grades of diastolic function. The area under the receiver operating characteristic curve for LATEF to differentiate between advanced DD (grades 2 and 3) and all other grades was 0.84 (0.79 to 0.88). Over a median of 4 years, 69 events (admissions for heart failure and cardiovascular deaths) occurred. By multivariate Cox analysis, LATEF &lt;40% provided incremental prognostic information after adjustments for advanced DD by echocardiography (hazard ratio 2.15, 95% confidence interval 1.13 to 3.94). There was a significant interaction (p=0.03) between LATEF and echocardiography-based diastolic grades. Stratified analyses within the diastolic function groups revealed that LATEF &lt;40% was equivalent to echocardiography in predicting events in the subgroup with advanced DD by echocardiography (p=0.20) but was associated with a significantly higher event rates in patients with normal filling pressures (p=0.0001) or indeterminate diastolic function (p=0.04) by echocardiography. In conclusion, LA function derived from CT can accurately detect advanced DD diagnosed by echocardiography and has additive value to echocardiography-derived DD.

Clinical event rate in patients with and without left main disease undergoing isolated coronary artery bypass grafting: results from the European DuraGraft Registry.

Left main coronary artery disease (LMCAD) is considered an independent risk factor for clinical events after coronary artery bypass grafting (CABG). We have conducted a subgroup analysis of the multicentre European DuraGraft Registry to investigate clinical event rates at 1 year in patients with and without LMCAD undergoing isolated CABG in contemporary practice. Patients undergoing isolated CABG were selected. The primary end point was the incidence of a major adverse cardiac event (MACE) defined as the composite of death, myocardial infarction (MI) or repeat revascularization (RR) at 1 year. The secondary end point was major adverse cardiac and cerebrovascular events (MACCE) defined as MACE plus stroke. Propensity score matching was performed to balance for differences in baseline characteristics. LMCAD was present in 1033 (41.2%) and absent in 1477 (58.8%) patients. At 1 year, the MACE rate was higher for LMCAD patients (8.2% vs 5.1%, P = 0.002) driven by higher rates of death (5.4% vs 3.4%, P = 0.016), MI (3.0% vs 1.3%, P = 0.002) and numerically higher rates of RR (2.8% vs 1.8%, P = 0.13). The incidence of MACCE was 8.8% vs 6.6%, P = 0.043, with a stroke rate of 1.0% and 2.4%, P = 0.011, for the LMCAD and non-LMCAD groups, respectively. After propensity score matching, the MACE rate was 8.0% vs 5.2%, P = 0.015. The incidence of death was 5.1% vs 3.7%, P = 0.10, MI 3.0% vs 1.4%, P = 0.020, and RR was 2.7% vs 1.6%, P = 0.090, for the LMCAD and non-LMCAD groups, respectively. Less strokes occurred in LMCAD patients (1.0% vs 2.4%, P = 0.017). The MACCE rate was not different, 8.5% vs 6.7%, P = 0.12. In this large registry, LMCAD was demonstrated to be an independent risk factor for MACE after isolated CABG. Conversely, the risk of stroke was lower in LMCAD patients. ClinicalTrials.gov NCT02922088.

Obstructive sleep apnoea-related respiratory events and desaturation severity are associated with the cardiac response.

BackgroundObstructive sleep apnoea (OSA) causes, among other things, intermittent blood oxygen desaturations, increasing the sympathetic tone. Yet the effect of desaturations on heart rate variability (HRV), a simple and noninvasive method for assessing sympathovagal balance, has not been comprehensively studied. We aimed to study whether desaturation severity affects the immediate HRV.MethodsWe retrospectively analysed the electrocardiography signals in 5-min segments (n=39 132) recorded during clinical polysomnographies of 642 patients with suspected OSA. HRV parameters were calculated for each segment. The segments were pooled into severity groups based on the desaturation severity (i.e. the integrated area under the blood oxygen saturation curve) and the respiratory event rate within the segment. Covariate-adjusted regression analyses were performed to investigate possible confounding effects.ResultsWith increasing respiratory event rate, the normalised high-frequency band power (HFNU) decreased from 0.517 to 0.364 (p<0.01), the normalised low-frequency band power (LFNU) increased from 0.483 to 0.636 (p<0.01) and the mean RR interval decreased from 915 to 869 ms (p<0.01). Similarly, with increasing desaturation severity, the HFNU decreased from 0.499 to 0.364 (p<0.01), the LFNU increased from 0.501 to 0.636 (p<0.01) and the mean RR interval decreased from 952 to 854 ms (p<0.01). Desaturation severity-related findings were confirmed by considering the confounding factors in the regression analyses.ConclusionThe short-term HRV response differs based on the desaturation severity and the respiratory event rate in patients with suspected OSA. Therefore, a more detailed analysis of HRV and desaturation characteristics could enhance OSA severity estimation.

Neutrophils and Circulating Inflammatory Biomarkers in Diabetes Mellitus and Heart Failure With Preserved Ejection Fraction

Heart failure with preserved ejection fraction (HFpEF) is characterized by low-grade chronic inflammation, which could be exacerbated by type 2 diabetes mellitus (DM). We hypothesized that neutrophils in patients with DM and patients with HFpEF with/without DM contribute to low-grade inflammation through the release of pro-inflammatory cytokines. Venous blood was withdrawn from patients with DM (n=22), HFpEF (n=15), HFpEF with DM (n=13), and healthy controls (CTL) (n=21). Levels of circulating cytokines and in vitro cytokines released by isolated neutrophils were assessed by enzyme-linked immunosorbent assay. Compared with CTL, there was a significant decrease in circulating nitric oxide in patients with DM (p ≤0.001), HFpEF (p ≤0.05), and HFpEF with DM (p ≤0.001) up to 44%. Circulating soluble intercellular adhesion molecule-1 and vascular cell adhesion molecule-1 levels increased (up to 2.5-fold and 1.9-fold, respectively; p ≤0.001) in patients with HFpEF and patients with HFpEF and DM, whereas soluble E-selectin only increased in patients with HFpEF and DM (1.4-fold, p ≤0.001). Circulating vascular endothelial growth factor levels were similar in CTL and patients with DM but were decreased in patients with HFpEF with/without DM (up to 94%; p ≤0.001). Circulating C-reactive protein, interleukin (IL)-8, IL-6, and IL-receptor antagonist increased in all patient groups with a maximum of 3.3-fold, 4.7-fold, 4.8-fold, and 1.6-fold, respectively, in patients with HFpEF and patients with DM. In vitro, lipopolysaccharide increased neutrophils IL-6 release from HFpEF with DM (3.7-fold; p ≤0.001), and IL-8 release from DM and HFpEF with DM versus CTL (2.8-fold and 10.1-fold, respectively; p ≤0.001). IL-1 receptor antagonist and vascular endothelial growth factor release from HFpEF neutrophils significantly decreased up to 87.0% and 92.2%, respectively, versus CTL. Neutrophils from patients with DM and HFpEF release more cytokines than CTL. This increase in pro-inflammatory status may explain the greater event rate in patients with HFpEF and DM.

Kidney Failure among Patients with Takotsubo Syndrome or Myocardial Infarction: A Retrospective Analysis.

Background: Takotsubo syndrome (TTS) is a syndrome with ambiguous pathophysiology. Impaired kidney function (KF) seems to impact the outcome of patients with TTS. We hypothesized that KF worsens the outcome among TTS patients and furthermore, TTS patients with concomitant KF experience more adverse events compared to myocardial infarction (MI) patients with concomitant KF. Methods and Results: This retrospective single-center study comprised two groups (cohorts) of patients including patients with TTS and concomitant KF (n = 61, 27.1%) and patients with MI and concomitant KF (n = 164, 72.9%). The clinical outcomes were delineated as short-term outcomes defined as in-hospital adverse events during index hospitalization and long-term outcomes defined as adverse events over five-year clinical follow-ups. All-cause mortality, stroke, cardiopulmonary resuscitation (CPR), life-threatening arrhythmias, need for respiratory support, and cardiogenic shock with subsequent use of inotropic agents during index hospitalization were denoted as in-hospital adverse events. All-cause mortality, rehospitalization due to heart failure, stroke, thromboembolic events, and the recurrence of primary pathology (TTS and MI) were analyzed during five-year follow-ups after index hospitalization. A higher mortality rate was noted among TTS patients with KF compared to TTS without KF. In addition, in-hospital event rates in patients with TTS and concomitant KF compared to MI and concomitant KF were comparable with the exception of a higher rate of respiratory support in TTS patients. The mortality rate was significantly higher among patients with TTS and KF at 4 years (29.5% vs. 15.9%, p = 0.02) and 5 years (34.4% vs. 20.7%, p = 0.03) in comparison to patients with MI and concomitant KF. In contrast, the rate of re-hospitalization related to heart failure was higher at 30 days, and at one-, four-, and five-year follow-ups in patients suffering from MI and KF compared to TTS and concomitant KF. Additionally, the recurrence of MI after 4 and 5 years was higher than the recurrence of TTS (4.9% vs. 15.2%; 4.9% vs. 16.5%). There were no differences in life-threatening arrhythmias and stroke in both groups. Conclusions: Patients with TTS and concomitant KF have higher all-cause mortality when compared to MI and concomitant KF. The mechanisms responsible remain to be determined.

Mortality and Cardiovascular Events in Patients With Chronic Kidney Disease and Sleep Apnea Syndrome

BackgroundThe incidence of sleep apnea syndrome (SAS) is reported to be markedly high in patients with chronic kidney disease (CKD). Therefore, it is extremely important to know whether SAS affects prognosis in patients with CKD. Further, it is imperative to understand the prognostic impact of home continuous positive airway pressure (CPAP) therapy, which is one of the most common treatments for SAS.Materials and MethodsWe used a clinical database to identify patients with CKD using diagnosis codes. We included patients with CKD aged 20 years or more, not on renal replacement therapy, with a known change in renal function for at least 1 year. The propensity score was used to compare event rates for patients with SAS and those without SAS. In addition, the prognostic impact of CPAP therapy was investigated. The primary outcome is a composite of death, initiation of renal replacement therapy, hospitalization for heart failure, ischemic heart disease, and cerebrovascular disease.ResultsFrom the database, 31,294 patients with CKD without SAS and 1,026 with SAS were found to be eligible. Of these, 419 (41%) patients with SAS and 10,713 (34%) patients without SAS (P < 0.01) reached the primary outcome. After adjustment with the propensity score, the SAS group was found to have a similarly poor prognosis (P < 0.01): the hazard ratio for the primary outcome was 1.26 (95% CI, 1.08–1.45, P < 0.01) in the group with SAS compared with the group without SAS. Conversely, in patients with SAS and using CPAP, the hazard ratio was lower and did not differ significantly (HR 0.96, 95% CI: 0.76–1.22, P = 0.76).ConclusionIn patients with CKD and SAS, the risk of death and cardiovascular disease is high. In addition, patients treated with CPAP may have improved life expectancy.

Mechanical Complications in Central Lines Using Taurolidine Versus Ethanol Lock Therapy in Children With Intestinal Failure.

Ethanol lock therapy (ELT) is effective in reducing rates of catheter-related-bloodstream infections (CRBSI) in the pediatric intestinal failure (IF) population; however, ELT may increase the risk of line occlusion and breakage, significantly impacting preservation of vascular access. During a period of ethanol shortage, Health Canada temporarily approved the use of taurolidine lock therapy (TLT) in pediatric iF patients previously utilizing ELT. This provided a unique opportunity to directly compare rates of central venous catheter (CVC) complications, including CRBSi, breaks, occlusions, repairs and replacements in patients who utilized both ELT and TLT. A retrospective study of pediatric IF patients managed by three Western Canadian intestinal rehabilitation programs was performed. Event rates in patients who used both ELT and TLT during the study period were compared using Poisson regression analysis. In 13 patients with 10,187 catheter days (CDs), TLT (vs ELT) had lower rates of CVC breaks (1.11 vs 5.19/1000 CDs, P < 0.001), occlusions (0.83 vs 4.06/1000 CDs, P = 0.01) and repairs (1.94 vs 5.64/1000 CDs, P = 0.01). There was no difference in CRBSI rates (0.83 vs 2.03/1000 CDs, P = 0.25) or rates of CVC replacements due to mechanical events (0.28 vs 1.81/1000 CDs, P = 0.08). Although there was no difference in CRBSI rates, TLT was associated with lower rates of mechanical complications compared to ELT in this study. Taurolidine may be a suitable alternative to ethanol in preventing CRBSI and may be associated with improved preservation of central lines in children with IF.

Duration and clinical outcome of dual antiplatelet therapy after percutaneous coronary intervention: a retrospective cohort study using a medical information database from Japanese hospitals

In this real-world, retrospective cohort study of 9753 patients in Japan prescribed dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI), we investigated DAPT duration and determined factors associated with early DAPT discontinuation and with event rates in patients who discontinued DAPT. The study period was April 1, 2012–March 31, 2018; endpoints comprised composite efficacy [death, myocardial infarction (MI), and stroke] and bleeding (intracranial, gastrointestinal, and requiring transfusion) endpoints. Overall, 68.8% of patients were continuing DAPT at 3 months post-PCI. Patients without major efficacy or safety events within 3 months after index PCI were included in a landmark analysis set (LAS; n = 7056), and categorized as DAPT ≥ 3 months (continuation) versus < 3 months (discontinuation). In the two LAS analysis groups, there was no difference in the composite bleeding endpoint (P = 0.067), although the incidence of the composite efficacy endpoint was higher in the discontinuation group (P < 0.001). In multivariate regression analysis, age ≥ 75 years, minor bleeding after PCI, history of cerebral infarction, history of cerebral or gastrointestinal bleeding, atrial fibrillation, dialysis, and anticoagulant use after PCI were associated with early DAPT discontinuation. Acute coronary syndrome, history of MI, kidney disorder, and anticoagulant use after PCI were associated with the composite efficacy endpoint in the discontinuation group. In conclusion, early DAPT discontinuation is more likely in patients at high bleeding risk, but may influence the occurrence of ischemic events in these patients. Determination of DAPT duration should take into account potential ischemic risk, even in patients at high bleeding risk.

Abstract WP136: Recurrent Intracerebral Hemorrhage In Patients With Cerebral Amyloid Angiopathy

Background: Studies suggest an increased risk of recurrent intracerebral hemorrhage (ICH) in patients with cerebral amyloid angiopathy (CAA). In this study, we sought to compare the rates of recurrent cerebrovascular events in patients admitted for ICH with and without CAA. Methods: We utilized the National Readmissions Database 2016-2018 to identify hospitalizations with the primary discharge diagnosis of ICH with and without a concomitant diagnosis of CAA. Hospitalizations with age &gt;55 years, survival to discharge, and known discharge disposition were included for further analysis. Propensity score matching was used to match for the differences in demographics, comorbidities, and disease severity between the CAA and no CAA groups. Survival analysis was performed to evaluate the rates of recurrent ICH, subarachnoid hemorrhage (SAH), and acute ischemic stroke (AIS) in the propensity-matched groups. Results: A total of 194,290 patients with ICH met the study inclusion criteria; 8,247 with CAA and 186,043 without CAA. After propensity score matching, we identified 7,857 hospitalizations with CAA and 7,874 without CAA. Patients with CAA were more likely to be readmitted due to ICH [hazards ratio (HR): 3.4, 95% confidence interval (CI): 2.6-4.6, P &lt;0.001] and SAH (HR: 2.5, 95% CI: 1.2-5.4, P 0.007) during the mean follow-up period of 6 months. However, there was no statistically significant difference in readmissions due to AIS (HR: 0.7, 95% CI: 0.5-1.0, P 0.061) [Figure 1]. Age (HR: 0.96 per year increase in age, 95% CI: 0.95-0.98, P &lt;0.001) and Medicare payer (HR: 3.23; 95% CI: 1.92-5.41, P &lt;0.001) were independently associated with readmissions due to ICH. Conclusions: Patients admitted for ICH with a secondary diagnosis of CAA are three times more likely to have readmissions for recurrent ICH compared to patients without CAA.

Are NOACs as safe and efficient as VKA regarding thromboembolic prophylaxis and major bleeding in patients with surgical bioprosthesis and atrial fibrillation within 3 months of surgery?

SummaryA best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was: ‘Are NOACs as safe and efficient as vitamin K antagonist regarding thromboembolic prophylaxis and major bleeding in patients with surgical bioprosthesis and atrial fibrillation within 3 months of surgery?’ Altogether more than 324 papers were found using the reported search, of which 6 represented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. The RIVER and ENAVLE trials showed non-inferiority of rivaroxaban (regarding mean time free from composite of death, major cardiovascular events or major bleeding at 12 months) and edoxaban (composite of death, clinical thromboembolic events or asymptomatic intracardiac thrombosis; and major bleeding) when compared with vitamin K antagonist. These studies include a low number of patients within 3 months of index surgery and overall low statistical power regarding this particular subgroup of patients. Data derived from lower evidence studies are compatible with the aforementioned findings. The available evidence suggests that non-vitamin K antagonist anticoagulants are as safe and as efficient as vitamin K antagonist regarding thromboembolic prophylaxis and bleeding event rates in patients with surgical bioprosthesis and atrial fibrillation within 3 months of bioprosthesis implantation. However, this evidence is derived from a limited number of studies with important methodological limitations. Expanding non-vitamin K antagonist anticoagulant recommendation to the early postoperative period warrants more confirmatory research.

Higher body mass index is associated with a lower iloprost infusion rate tolerance and higher iloprost-related adverse events in patients with systemic sclerosis.

Systemic sclerosis (SSc) is an autoimmune disease characterized by vasospasm and microvascular involvement. Iloprost (ILO), a prostaglandin analogous, is used for the treatment of SSc-related Raynaud's phenomenon and digital ulcers. The suggested dose is 0.5-2 ng/kg/min for 6-8 h, and the maximum dose is decided upon the patient's tolerance. This study aims to analyze ILO infusion tolerance and possible predictive factors in patients with SSc. This is a retrospective observational study. We evaluated 113 patients with SSc beginning ILO intravenous (IV) infusion treatment between 2004 and 2021. We assessed the maximum tolerated ILO IV infusion rate, the incidence of adverse events (AEs), and the need for symptomatic therapy during the dose-finding sessions. We collected relevant demographic and medical and employed generalized linear models to assess possible predictors of maximum tolerated ILO infusion rate and AEs and logistic regression to assess predictors of AEs. The median ILO infusion rate at the end of the dose-finding process was 0.88 ng/kg/min [interquartile range (IQR) = 0.37]. We found a significant inverse correlation between ILO infusion rate and body mass index (BMI) at the beginning of treatment. BMI was negatively associated with ILO infusion rate (β = -0.21, p = 0.02) after correction for relevant confounding factors. Overweight patients (BMI >26) presented a 13-fold increased risk of developing AEs during ILO titration [adjusted odds ratio = 13.979, 95% confidence interval (CI) = 2.359-82.845]. AEs during ILO titration occurred in 47.8% of patients, of whom 22.2% presented hypotension. Other AEs were headache, nausea, vomiting, diarrhea, and edema. Symptomatic therapy was needed in half of the patients at least once. This study showed that higher BMI was statistically associated with lower ILO infusion rate tolerance and higher AEs rate, underlying a possible BMI-dependent endothelial dysfunction. Individual ILO regimens still need to be tailored to the patient. Introduction: Systemic sclerosis is a rare a rheumatic disease characterized by skin thickening, vasospasm, and digital ulcers (DUs), as well as other organs involvement. Iloprost, which is administered as intravenous infusion, is one of the main treatments for this disease, and it is effective in reducing vasospasm and the frequency of DUs. Even if there is a suggested dose range, the exact dose must be tailored on each patient, because the tolerance to the drug is variable. Tolerance is limited by dose-dependent unwanted effects, as headache, low blood pressure, dizziness, and sickness. This study aimed to identify possible predictors of such tolerance.Materials and Methods: We collected data from our patients with systemic sclerosis beginning the treatment with iloprost between January 2004 and November 2021 at our hospital facility in Verona, Italy, and analyzed different factors that could be associated with a better tolerance, as age, sex, disease duration, smoking habit, body mass index (a measure of body fatness), blood pressure, concomitant medications, and different patterns of the disease.Results: We found that a higher body mass index was associated with lower iloprost tolerance and higher adverse events rate in patients with systemic sclerosis, while we did not find a correlation with other factors. We believe overweight and obese patients (who have a higher body mass index) have a defect in the vasodilatation mechanism and can therefore be more susceptible to the effect of this medication.Conclusions: While preliminary, our results could provide a good starting point to develop a predictive tool to limit adverse events during this therapy.

Abstract 12301: Anticoagulation for Left Ventricular Thrombus: An Updated Meta-Analysis of Stroke or Systemic Embolization Outcomes

Introduction: Thromboembolic events including stroke or systemic embolization (SSE) are the most dreaded complications in patients who develop left ventricular (LV) thrombus. Vitamin K antagonists (VKAs) and non-vitamin K oral anticoagulants (NOACs) have been used in the management of LV thrombus however the efficacy of these treatment strategies have been rarely studied in head-to-head trials. Our aim was to study the differences in embolization outcomes in patients with LV thrombus on either NOACs or VKAs. Methods: A comprehensive search of electronic databases was conducted for studies comparing VKAs and NOACs in patients with LV thrombus. Event level data were extracted from studies for each arm and used to calculate the risk ratio (RR) with 95% confidence intervals (CI) which were pooled for the effect of original treatment allocation on the outcome of SSE. Random effects model was used to calculate the risk ratio. Results: We found a total of 12 studies from which 2281 patients were identified with LV thrombus and were treated with anticoagulation. 596 (26.13%) received NOACs and 1685 (73.87%) received VKAs. Events of SSE occurred in 92 (15.44%) patients on NOACs and 307 (18.22%) patients on VKAs. Overall, patients treated with NOACs had similar rate of SSE events as compared to patients treated with VKAs using random effects model (RR: 1.02 [95% 0.64-1.65], p=0.08, I 2 =39%). Conclusions: This meta-analysis suggests that the use of NOACs is associated similar rate of SSE events in patients with LV thrombus as compared to the use of VKAs. Additional prospective studies are required to determine the most effective anticoagulant strategy for patients with LV thrombus.

Rivaroxaban for extended thromboprophylaxis in acutely ill medical patients 75 years of age or older

BackgroundAlthough older patients are at increased risk for venous thromboembolism (VTE), thromboprophylaxis is underused because of bleeding concerns. The MARINER trial evaluated whether rivaroxaban reduced symptomatic postdischarge VTE in acutely ill medical patients. ObjectivesWe hypothesized that rivaroxaban would have a favorable benefit/risk profile in patients ≥75 years of age. MethodsPatients were randomized in a double‐blind manner at hospital discharge to rivaroxaban (10 mg/day for creatinine clearance ≥50 ml/min; 7.5 mg/day for ≥30‐<50 ml/min) or placebo for 45 days. Using a Cox proportional hazard model including treatment as a covariate, we compared the risk of the primary efficacy outcome (symptomatic VTE plus VTE‐related death in the intention‐to‐treat population) and safety outcome (International Society on Thrombosis and Haemostasis major bleeding in the safety population) in the prespecified subgroups of patients ≥ and <75 years of age. ResultsThe primary event rate in patients ≥75 years of age was 2‐fold higher than that in those <75 years. The incidence of the primary efficacy outcomes in both age groups was numerically lower with rivaroxaban than with placebo (≥75: 1.2% and 1.6%, HR 0.73, 95% CI 0.43‐1.22; <75 0.6% and 0.8%, HR 0.78, 95% CI 0.46‐1.32; interaction p‐value for age group = .85). The incidence of major bleeding was low and similar in the two age and treatment groups (interaction p value for age group = .35). ConclusionSymptomatic VTE and VTE‐related death occur frequently in older patients with acute medical illness. The benefit/risk profile of rivaroxaban in patients ≥75 years of age appears consistent with that observed in the general population.

Prognostic Impact of Calcified Plaque Morphology After Drug Eluting Stent Implantation - An Optical Coherence Tomography Study.

Optical coherence tomography (OCT) has the potential to characterize the detailed morphology of calcified coronary plaques. This study examined the prognostic impact of calcified plaque morphology in patients with coronary artery calcification (CAC) who underwent newer-generation drug-eluting stent (DES) implantation. In all, 251 patients with moderate to severe CAC who underwent OCT-guided DES implantation were reviewed retrospectively and divided into 3 groups according to OCT findings of the target lesion: 25 patients (10.0%) with calcified nodules (CN), 69 patients (27.5%) with calcified protrusion (CP) without CN, and 157 patients (62.5%) with superficial calcific sheet (SC) without CN and CP. The primary endpoint was major adverse cardiac events (MACE), defined as a composite of cardiac death, myocardial infarction, and target lesion revascularization (TLR). Kaplan-Meier survival analysis revealed that, among the 3 groups, the rates of MACE-free survival (log-rank test, P=0.0117), myocardial infarction (log-rank test, P=0.0103), and TLR (log-rank test, P=0.0455) were significantly worse in patients with CN. Multivariate Cox proportional hazards analysis demonstrated that CN was an independent predictor of MACE (hazard ratio 4.41; 95% confidence interval 1.63-10.8; P=0.0047). Target lesion CN was associated with higher cardiac event rates in patients who underwent newer-generation DES implantation for lesions with moderate to severe CAC.

Prognostic advantage of optimal medical therapy is not cancelled in hospitalized heart failure patients receiving regular hemodialysis

Abstract Background As the first-line medications, renin-angiotensin-aldosterone system inhibitor (RAASi) and β-blocker provide prognostic benefits in patients with heart failure (HF) and reduced left ventricular ejection fraction (LVEF). However, the negative inotropic effect of these drugs may destabilize the hemodynamics during hemodialysis (HD) and become prognostically controversial in patients receiving regular HD. Indeed, prior studies have reported the cancellation of the favorable prognostic effects of RAASi and β-blocker in patients with HD. However, it is totally unknown whether the guideline-directed medical therapy affects the prognosis in HF patients receiving regular HD. Purpose We aimed to evaluate the prognostic impact of RAASi and β-blocker on the cardiovascular (CV) events in HF patients on regular HD. Methods This observational study initially included 1,930 consecutive patients who were hospitalized due to HF and discharged alive. Of these, 151 patients who received regular HD were ultimately analyzed. They were classified into 3 groups depending on the prescribing medications at discharge; patients who received none of RAASi or β-blocker (None group: N=19), either RAASi or β-blocker (Either group: N=56), and both RAASi and β-blocker (Both group: N=76). The primary endpoint was a composite of CV death and readmission due to HF. Results During the observation period of median 501 (interquartile range: 197–954) days, the primary endpoint occurred in 61 patients (40%). Kaplan-Meier analysis showed the highest rate of composite endpoint in the None group (log-rank for trend: p&amp;lt;0.001, Figure). After adjusting for covariates of age, sex, LVEF, and systolic blood pressure and heart rate at discharge, the hazard ratio (HR) for a composite endpoint was significantly lower in the Either group or Both group than that in the None group [HR: 0.19, 95% confidence interval (CI): 0.08–0.45; HR: 0.16, 95% CI: 0.06–0.42, respectively]. Conclusions The prescription of RAASi or β-blocker at discharge was associated with lower adverse CV event rates in patients on regular HD who were hospitalized for HF. In order to improve long-term prognosis of HF patients on HD, we should consider the prescription of RAASi or β-blocker for them if hemodynamics during HD is affordable. Funding Acknowledgement Type of funding sources: None. Figure 1

Oral anticoagulation therapy with rivaroxaban in elderly patients with atrial fibrillation. Results from EMIR study

Abstract Background Atrial fibrillation (AF) in elderly patients increases both bleeding and thromboembolic risks. Elderly patients benefit as much from anticoagulation therapy with positive net clinical benefit. However, there have been few studies that focused on the efficacy and safety of direct oral anticoagulants in elderly patients. The aim of this subanalysis from EMIR study was to assess the effectiveness of rivaroxaban in patients older than 75 years old. Methods EMIR Study (acronym from 'Estudio observacional para la identificaciόn de los factores de riesgo asociados a eventos cardiovasculares Mayores en pacientes con fIbrilaciόn auricular no valvular tratados con un anticoagulante oral directo (Rivaroxaban)') was an observational, multicenter, post-authorization and prospective study that involved AF patients under oral anticoagulation with rivaroxaban at least 6 months before enrolment. We analyzed baseline clinical characteristics and adverse events after 2.5 years of follow up. Results We analyzed 1,433 patients with median age of 74.7 (67.7–81.6). Of them 691 (48.2%) were ≥75 years. Elderly patients had higher prevalence of cardiovascular risk factors such previous stroke (16.8% vs 8.5%; p&amp;lt;0.001), heart failure (25.0% vs 20.6%; p&amp;lt;0.001), higher CHA2DS2-VASc (4.4±1.3 vs 2.7±1.2; p&amp;lt;0.001) and HAS-BLED (1.9±1.0 vs 1.2±1.0; p&amp;lt;0.001) scores. After 2.5 (2.2–2.6) years of follow-up, we observed low rate of adverse events in patients under rivaroxaban therapy. We observed higher rate of adverse events in elderly population for thromboembolic events (1.13%/year vs 0.36%/year; p=0.017) and major bleeding events (1.80%/year vs 0.36%/year; p&amp;lt;0.001) but those adverse rates were lower than expected according to previous studies (i.e. ROCKET-AF trial, rivaroxaban group had 4.86%/year of major bleeding or in XANTUS study was 3.2%/year of major bleeding in patients &amp;gt;75 years). We did not observe differences between groups from MACE (1.13%/year vs 1.01%/year; p=0.875) or cardiovascular death (0.86%/year vs 0.42%/year; p=0.170). Conclusion In real-world elderly population, rivaroxaban showed higher rates of thromboembolic and major bleeding events in elderly patients but with annual rates lower than expected according to previous studies like ROCKET-AF or XANTUS. Similar annual rates in elderly were observed for MACE and cardiovascular mortality than in younger patients, being rivaroxaban a good therapeutic alternative even for the elderly. Funding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Bayer Hispania S.L.

The predictive value of high-sensitive troponin I for perioperative risk in patients undergoing gastrointestinal tumor surgery.

BackgroundThe incidence of cardiovascular events in perioperative period of gastrointestinal tumor surgery cannot be ignored, and studies have shown that level of postoperative troponin is related to the postoperative risk of non-cardiac surgery. However, the relationship between pre-operative troponin levels and perioperative risk of gastrointestinal tumor surgery is unclear. Thus, we aimed to evaluate the value of high-sensitive cardiac troponin I (hs-cTnI) prior to gastrointestinal tumor surgery for perioperative risk assessment.MethodsIn this retrospective cohort study, 1259 patients who underwent gastrointestinal tumor surgery and had been tested for hs-cTnI on admission within 7 days prior to surgery were retrospectively recruited from January 2018 to June 2020. The primary combined endpoint including in-hospital all-cause mortality, acute myocardial infarction, cardiac arrest or ventricular fibrillation and acute decompensated heart failure. The secondary endpoint included total hospital stay and requirement of intensive care treatment.FindingsCompared with patients with normal hs-cTnI, those with elevated hs-cTnI (> 0·028 ng/ml) were more likely to experience the combined endpoint (28·2% versus 2·7%, P < 0·001) and there was also an increasing rate of in mortality in elevated hs-cTnI group (2·4% versus 0·3%, P = 0·057). The length of total hospital stay was significantly longer in patients with elevated hs-cTnI (24·8 ± 16·3 versus 19·5 ± 7·9, P = 0·003) and the number of patients requiring intensive care treatment was also higher (22·6% versus 4·2%, P < 0·001). The area under the ROC curve assessing hs-cTnI in predicting in-hospital mortality was 0·787 [95% confidence interval (CI) 0·612–0·963, P = 0·015] and for combined endpoint was 0·822 [95% CI 0·766–0·879, P < 0·001]. Hs-cTnI > 0·028 ng/ml was associated with significantly higher cardiovascular event rate in patients with the revised cardiac index ≤ 1. The positive likelihood ratio of hs-cTnI (> 0·028 ng/ml) for predicting combined endpoint reaches 10.5 in patients with Lee index = 0. In multivariate logistic analyses, hs-cTnI was one of the best predictors for the combined endpoint [odds ratio (OR) 5·924 (95%CI: 2·869–12·233), P < 0·001].InterpretationHs-cTnI provides powerful prognostic information for patients undergoing gastrointestinal tumor surgery, and therefore provides reliable prognostic information incremental to revised cardiac index.

MP58-09 RISK OF 30-DAY MORTALITY AND CARDIOPULMONARY COMPLICATIONS IN PATIENTS UNDERGOING EMERGENCY SURGERY WITH PERIOPERATIVE SARS-COV-2 INFECTION

INTRODUCTION AND OBJECTIVE: Continued vigilance of operative outcomes of COVID-19 patients is important given the relative novelty of the SARS-CoV-2 infection. We here sought to evaluate the 30-day mortality and cardiopulmonary adverse event rates in patients undergoing emergency surgery with perioperative COVID-19 infection, in comparison to a control group of medically managed COVID-19 patients that did not require surgical intervention. METHODS: A retrospective review of electronic medical data from a single tertiary-care center in Michigan was undertaken. Patients who had tested positive for SARS-CoV-2 infection either 7 days before or within 30 days after surgery during March-May 2020 were included in the study (n=52). Propensity score matched (1:6) patients who had been positive for SARS-CoV-2 infection during this time-period but did not undergo surgery were used as controls (n=314, Figure 1). The primary endpoint was 30-day mortality. Secondary endpoints included cardiac and pulmonary complications. Multivariable logistic regression analyses were utilized to account for baseline differences. A pvalue 0.10 for all 3 endpoints). CONCLUSIONS: Patients undergoing emergency surgery with a co-diagnosis of SARS-CoV-2 infection in the perioperative period do not have an increased risk for short-term mortality or cardiopulmonary complications compared to the medically treated COVID-19 patients.