Interatrial Shunt Treatment for Heart Failure: The Randomized RELIEVE-HF Trial.

BACKGROUND: An interatrial shunt may provide an autoregulatory mechanism to decrease left atrial pressure and improve heart failure (HF) symptoms and prognosis. METHODS: Patients with symptomatic HF with any left ventricular ejection fraction (LVEF) were randomized 1:1 to transcatheter shunt implantation versus a placebo procedure, stratified by reduced (≤40%) versus preserved (>40%) LVEF. The primary safety outcome was a composite of device-related or procedure-related major adverse cardiovascular or neurological events at 30 days compared with a prespecified performance goal of 11%. The primary effectiveness outcome was the hierarchical composite ranking of all-cause death, cardiac transplantation or left ventricular assist device implantation, HF hospitalization, outpatient worsening HF events, and change in quality of life from baseline measured by the Kansas City Cardiomyopathy Questionnaire overall summary score through maximum 2-year follow-up, assessed when the last enrolled patient reached 1-year follow-up, expressed as the win ratio. Prespecified hypothesis-generating analyses were performed on patients with reduced and preserved LVEF. RESULTS: Between October 24, 2018, and October 19, 2022, 508 patients were randomized at 94 sites in 11 countries to interatrial shunt treatment (n=250) or a placebo procedure (n=258). Median (25th and 75th percentiles) age was 73.0 years (66.0, 79.0), and 189 patients (37.2%) were women. Median LVEF was reduced (≤40%) in 206 patients (40.6%) and preserved (>40%) in 302 patients (59.4%). No primary safety events occurred after shunt implantation (upper 97.5% confidence limit, 1.5%; P<0.0001). There was no difference in the 2-year primary effectiveness outcome between the shunt and placebo procedure groups (win ratio, 0.86 [95% CI, 0.61-1.22]; P=0.20). However, patients with reduced LVEF had fewer adverse cardiovascular events with shunt treatment versus placebo (annualized rate 49.0% versus 88.6%; relative risk, 0.55 [95% CI, 0.42-0.73]; P<0.0001), whereas patients with preserved LVEF had more cardiovascular events with shunt treatment (annualized rate 60.2% versus 35.9%; relative risk, 1.68 [95% CI, 1.29-2.19]; P=0.0001; Pinteraction<0.0001). There were no between-group differences in change in Kansas City Cardiomyopathy Questionnaire overall summary score during follow-up in all patients or in those with reduced or preserved LVEF. CONCLUSIONS: Transcatheter interatrial shunt implantation was safe but did not improve outcomes in patients with HF. However, the results from a prespecified exploratory analysis in stratified randomized groups suggest that shunt implantation is beneficial in patients with reduced LVEF and harmful in patients with preserved LVEF. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03499236.

Final 5-year report of BIONYX comparing the thin-composite wire-strut zotarolimus-eluting stent versus ultrathin-strut sirolimus-eluting stent.

BACKGROUND: The BIONYX randomized trial is the first study to evaluate the Resolute Onyx durable polymer-coated zotarolimus-eluting stent (ZES) in all-comers. Furthermore, it is the first trial to assess safety and efficacy of this stent versus the Orsiro biodegradable-polymer sirolimus-eluting stent (SES) in all-comers, paying particular attention to patients with diabetes. It has previously shown promising results until 3 years of follow-up. AIMS: We aimed to assess long-term clinical outcome after percutaneous coronary intervention (PCI) with Onyx ZES versus Orsiro SES at 5-year follow-up. METHODS: The main composite endpoint was target vessel failure (TVF): cardiac death, target vessel myocardial infarction, or target vessel revascularization. Time to primary and secondary endpoints was assessed using Kaplan-Meier methods, applying the log-rank test for between-group comparison. RESULTS: Follow-up was available in 2414/2488 (97.0%) patients. After 5 years, TVF showed no significant difference between Onyx ZES and Orsiro SES (12.7% vs. 13.7%, hazard ratio [HR] 0.94, 95% confidence interval [CI] [0.75-1.17], plog-rank = 0.55). Landmark analysis between 3- and 5-year follow-up found a lower target lesion revascularization rate for Onyx ZES (1.1% vs. 2.4%, HR 0.47, 95% CI [0.24-0.93], plog-rank = 0.026). A prespecified subgroup analysis showed no significant between-stent difference in clinical outcome among patients with diabetes. After treatment with Onyx ZES, patients aged ≥75 years had significantly lower rates of TVF (13.8% vs. 21.9%, HR 0.60, 95% CI [0.39-0.93], plog-rank = 0.023). CONCLUSIONS: The final 5-year analysis of the randomized BIONYX trial showed favorable and similar long-term outcomes of safety and efficacy for Onyx ZES and Orsiro SES in both all-comers and patients with diabetes.

Percutaneous coronary intervention with ridaforolimus eluting-stents in small vessel coronary artery disease.

INTRODUCTION: The ridaforolimus-eluting stent (RES) system uses a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting ridaforolimus. AIM OF STUDY: To assess the safety and efficacy of small diameter (2.25 mm) RES (EluNIR) in small coronary artery disease. METHODS: A prospective, multicenter, single-arm, open-label clinical trial. Clinical follow-up was performed at 30 days, 6 months, and 1 year after the procedure. Target lesions were located in native coronary arteries or bypass graft conduits, with visually estimated diameter of ≥2.25 mm to ≤2.5 mm. The primary endpoint was combined device success, defined as final in-stent residual diameter stenosis <30%, without 30-day major adverse cardiovascular events (MACE). RESULTS: A total of 81 patients were enrolled in the study. Twenty-three patients (28%) had acute coronary syndrome (ACS) at presentation and 37 (46%) had prior myocardial infarction (MI). Most of the target lesions were located in the circumflex coronary artery (44%) and were classified as B2/C grade according to the American Heart Association/American College of Cardiology classification. The final mean minimal lumen diameter, mean reference vessel diameter, and mean residual percent diameter stenosis were 2.0 ± 0.2 mm, 2.3 ± 0.1 mm, and 14 + 6.6%, respectively. The primary endpoint of device success without 30-day MACE was achieved in 98.8% of the patients. Target lesion failure (TLF) at 6 months was 1.2%. Thirty-day and 1-year MACE rates were 1.2% and 2.5%, respectively. CONCLUSION: The EluNIR 2.25 mm stent shows excellent results in small coronary artery disease and adds another tool in the treatment of this complex lesion type.

SCMR expert consensus statement for cardiovascular magnetic resonance of patients with a cardiac implantable electronic device.

Cardiovascular magnetic resonance (CMR) is a proven imaging modality for informing diagnosis and prognosis, guiding therapeutic decisions, and risk stratifying surgical intervention. Patients with a cardiac implantable electronic device (CIED) would be expected to derive particular benefit from CMR given high prevalence of cardiomyopathy and arrhythmia. While several guidelines have been published over the last 16 years, it is important to recognize that both the CIED and CMR technologies, as well as our knowledge in MR safety, have evolved rapidly during that period. Given increasing utilization of CIED over the past decades, there is an unmet need to establish a consensus statement that integrates latest evidence concerning MR safety and CIED and CMR technologies. While experienced centers currently perform CMR in CIED patients, broad availability of CMR in this population is lacking, partially due to limited availability of resources for programming devices and appropriate monitoring, but also related to knowledge gaps regarding the risk-benefit ratio of CMR in this growing population. To address the knowledge gaps, this SCMR Expert Consensus Statement integrates consensus guidelines, primary data, and opinions from experts across disparate fields towards the shared goal of informing evidenced-based decision-making regarding the risk-benefit ratio of CMR for patients with CIEDs.

In-Hospital Outcomes of Ventricular Tachycardia Catheter Ablation in the Presence of Intra-Cardiac Thrombus.

BACKGROUND: Ventricular tachycardia (VT) catheter ablation in the presence of intracardiac thrombi was evaluated in very few studies. OBJECTIVES: To investigate in-hospital outcomes of VT ablation in the presence of an intracardiac thrombus, in a large inpatient US registry. METHODS: Using the National Inpatient Sample (NIS) database, patients who underwent non-elective VT catheter ablations in the United States between 2016 and 2019 were identified using ICD-10 codes. Sociodemographic, clinical data, in-hospital procedures, and outcomes as well as in-hospital mortality were collected. In-hospital outcomes were compared using propensity score (PS) matching analysis with a 1:3 ratio between patients with and without intracardiac thrombus. RESULTS: A weighted total of 15,725 admissions for non-elective VT ablation were included in the study, of which 190 (1.2%) had a discharge diagnosis of intracardiac thrombus. Patients with intracardiac thrombus had a higher comorbidity burden and were more likely to have ischemic cardiomyopathy and a diagnosis of cardiac aneurysm. In PS analysis, the presence of intracardiac thrombus was significantly associated with higher rates of any in-hospital complications (42.1% vs. 19.3%, p < 0.009), driven by higher periprocedural cerebrovascular accident and vascular injury events. In-hospital mortality rates were not significantly different between the groups. CONCLUSIONS: In patients undergoing non-elective VT ablation, intracardiac thrombus was associated with higher rates of in-hospital complications, but not higher in-hospital mortality. These findings suggest that intracardiac thrombus should not contraindicate VT ablation when deemed necessary, while efforts should be made to decrease potential complications.

Prognosis of Patients with Crohn's Disease and Ulcerative Colitis Following Percutaneous Coronary Intervention Procedures.

BACKGROUND: Patients with inflammatory bowel disease (IBD) are at increased risk after percutaneous coronary intervention (PCI). OBJECTIVES: To compare the clinical outcomes within 30 days, one year, and five years of undergoing PCI. METHODS: We conducted a retrospective cohort study of adult patients with IBD who underwent PCI in a tertiary care center from January 2009 to December 2019. RESULTS: We included 44 patients, 26 with Crohn's disease (CD) and 18 with ulcerative colitis (UC), who underwent PCI. Patients with CD underwent PCI at a younger age compared to UC (57.8 vs. 68.9 years, P < 0.001) and were more likely to be male (88.46% of CD vs. 61.1% of UC, P < 0.03). CD patients had a higher rate of non-steroidal treatment compared to UC patients (50% vs. 5.56%, P < 0.001). Acute coronary syndromes (ACS) and/or the need for revascularization (e.g., PCI) were the most common clinical events to occur following PCI, in both groups. Of patients who experienced ACS and/or unplanned revascularization within 5 years, 25% of UC vs. 40% of CD had target lesion failure (TLF) due to in-stent restenosis and 10% of CD had TLF due to stent thrombosis. CONCLUSIONS: We observed higher rates of TLF in IBD patients compared to the general population as well as differences in clinical outcomes between UC and CD patients. A better understanding of the prognostic factors and pathophysiology of these differences may have clinical importance in tailoring the appropriate treatment or type of revascularization for this high-risk group.

Ethnic minorities treated with new-generation drug-eluting coronary stents in two European randomised clinical trials.

BACKGROUND: Several ethnic minorities have an increased risk of cardiovascular events, but previous European trials that investigated clinical outcome after coronary stenting did not assess the patients' ethnic background. AIMS: To compare ethnic minority and Western European trial participants in terms of both cardiovascular risk profile and 1­year clinical outcome after percutaneous coronary intervention. METHODS: In the BIO-RESORT and BIONYX randomised trials, which assessed new-generation drug-eluting stents, information on patients' self-reported ethnic background was prospectively collected. Pooled patient-level data of 5803 patients, enrolled in the Netherlands and Belgium, were analysed in this prespecified analysis. The main endpoint was target vessel failure after 1 year. RESULTS: Patients were classified as belonging to an ethnic minority (n = 293, 5%) or of Western European origin (n = 5510, 95%). Follow-up data were available in 5772 of 5803 (99.5%) patients. Ethnic minority patients were younger, less often female, more often current smokers, more often medically treated for diabetes, and more often had a positive family history of coronary artery disease. The main endpoint target vessel failure did not differ between ethnic minority and Western European patients (3.5% vs 4.9%, hazard ratio 0.71, 95% confidence interval 0.38-1.33; p = 0.28). There was also no difference in mortality, myocardial infarction, and repeat revascularisation rates. CONCLUSIONS: Despite the unfavourable cardiovascular risk profile of ethnic minority patients, short-term clinical outcome after treatment with contemporary drug-eluting stents was highly similar to that in Western European patients. Further efforts should be made to ensure the enrolment of more ethnic minority patients in future coronary stent trials.

Sex-based treatment and outcomes for coronary bifurcation stenting: A report from the e-ULTIMASTER registry.

BACKGROUND: Percutaneous coronary intervention (PCI) for bifurcation lesions can be technically challenging and is associated with higher risk. There is little data on sex-based differences in strategy and outcomes in bifurcation PCI. AIMS: We sought to assess whether differences exist between women and men in the treatment and outcomes of bifurcation PCI. METHODS: We collected data on 4006 patients undergoing bifurcation PCI, from the e-ULTIMASTER study, a prospective, multicentre study enrolling patients from 2014 to 2018. We divided the bifurcation cohort according to sex, with 1-year follow-up of outcomes (target lesion failure [TLF], target vessel failure [TVF], and patient-oriented composite endpoint [POCE]). FINDINGS: Women were older (69.2 ± 10.9 years vs. 64.4 ± 11.0 years), with a greater burden of cardiovascular comorbidities. For true and non-true bifurcation lesions, women and men were equally likely to undergo a single stent approach (true: 63.2% vs. 63.6%, p = 0.79, non-true: 95.4% vs. 94.3%, p = 0.32), with similar rates of final kissing balloon (FKB) (37.2% vs. 35.5%, p = 0.36) and proximal optimization (POT) (34.4% vs. 34.2%, p = 0.93) in cases where two stents were used. Lastly, after propensity score matching, there was no difference between women and men in the incidence of the composite endpoints of TLF (5.5% vs. 5.2%, RR 1.05 [95% CI 0.77-1.44], p = 0.75), TVF (6.2% vs. 6.3%, RR 0.99 [95% CI 0.74-1.32], p = 0.96), and POCE (9.9% vs. 9.5%, RR 1.05 [95% CI 0.83-1.31], p = 0.70). CONCLUSION: In this contemporary, real-world study of bifurcation PCI, we report no difference in stent strategy between women and men, with similar outcomes at 1-year.

Risk of ionizing radiation in pregnancy: just a myth or a real concern?

There are natural concerns regarding the risks posed to the foetus by ionizing radiation exposure during pregnancy. Therefore, many female physicians select to avoid working in an environment associated with ionizing radiation exposure like the catheterization laboratory and even exclude training as electrophysiology, interventional cardiologists, or radiologists. For those already working in this field, pregnancy involves usually a 1-year interruption (pregnancy and maternity leave) to their careers, leading at times to delays in the decision to become pregnant. This review describes the low added risk of malformation/cancer in the offspring, highlight gaps in our understanding, discuss several common wrong beliefs, and recommend how to further decrease radiation dose, especially during pregnancy.

Safety of catheter ablation for atrial fibrillation in patients with mechanical prosthetic valves.

BACKGROUND: Catheter ablation (CA) for atrial fibrillation (AF) is increasingly utilized in recent years, with promising results. We aimed to investigate the nationwide trends in utilization and procedural complications of CA for AF in patients with mechanical prosthetic valves (MPVs). METHODS AND RESULTS: We drew data from the US National Inpatient Sample (NIS) database to identify cases of AF ablations in patients with MPVs, between 2003 and 2015. Sociodemographic and clinical data were collected, and incidence of procedural complications, mortality, and length of stay were analyzed. We compared the outcomes to a propensity-matched cohort of patients without MPVs. The study included a weighted total of 1898 CA for AF cases in patients with MPVs. The median age of the study population was 67 (61-75) years and 53% were males. Despite the increasing age and significant uptrend in the prevalence of individual comorbidities and Deyo-Charlson Comorbidity Index (CCI) over the years, the risk of peri-procedural complications and mortality in the study group did not change between the early (2003-2008) and late (2009-2015) study years. The peri-procedural complication rate (8.4% vs. 10.4%, p = .33) and in-hospital mortality (0.2% vs. 0.2%, p = .9) did not differ significantly between patients with MPVs and 1901 matched patients without MPVs. Length of stay was higher among patients with prior MPVs compared to the controls (4.0 ± 0.2 vs. 3.3 ± 0.2 days, p = .011). CONCLUSION: This nationwide analysis shows that AF ablation in patients with mechanical valve prothesis bares a similar risk of periprocedural complications and mortality as in patients without prosthetic valves.

The Impact of Obesity on Sudden Cardiac Death Risk.

PURPOSE OF REVIEW: We aimed to describe the epidemiology of sudden cardiac death (SCD) in the obese, elaborating on the potential pathophysiological mechanisms linking obesity, SCD, and the outcomes in SCD survivors, as well as looking into the intriguing "obesity paradox" in these patients. RECENT FINDINGS: Several studies show increased mortality in patients with BMI > 30 kg/m2 admitted to the hospital following SCD. At the same time, other studies have implied that the "obesity paradox," described in various cardiovascular conditions, applies to patients admitted after SCD, showing lower mortality in the obese compared to normal weight and underweight patients. We found a significant body of evidence to support that while obesity increases the risk for SCD, the outcomes of obese patients post SCD are better. These findings should not be interpreted as supporting weight gain, as it is always better to prevent the "disaster" from happening than to improve your chances of surviving it. Obesity is shown to be significantly associated with increased risk for SCD; however, there is a growing body of evidence, supporting the "obesity paradox" in the survival of SCD victims. Prospectively, well-designed studies are needed to confirm these findings.

Impact of prediabetes and diabetes on 3-year outcome of patients treated with new-generation drug-eluting stents in two large-scale randomized clinical trials.

BACKGROUND: Diabetes is associated with adverse outcomes after percutaneous coronary intervention with drug-eluting stents (DES), but for prediabetes this association has not been definitely established. Furthermore, in patients with prediabetes treated with contemporary stents, bleeding data are lacking. We assessed 3-year ischemic and bleeding outcomes following treatment with new-generation DES in patients with prediabetes and diabetes as compared to normoglycemia. METHODS: For this post-hoc analysis, we pooled patient-level data of the BIO-RESORT and BIONYX stent trials which both stratified for diabetes at randomization. Both trials were multicenter studies performed in tertiary cardiac centers. Study participants were patients of whom glycemic state was known based on hemoglobin A1c, fasting plasma glucose, or medically treated diabetes. Three-year follow-up was available in 4212/4330 (97.3 %) patients. The main endpoint was target vessel failure, a composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization. RESULTS: Baseline cardiovascular risk profiles were progressively abnormal in patients with normoglycemia, prediabetes, and diabetes. The main endpoint occurred in 54/489 patients with prediabetes (11.2 %) and 197/1488 with diabetes (13.7 %), as compared to 142/2,353 with normoglycemia (6.1 %) (HR: 1.89, 95 %-CI 1.38-2.58, p < 0.001, and HR: 2.30, 95 %-CI 1.85-2.86, p < 0.001, respectively). In patients with prediabetes, cardiac death and target vessel revascularization rates were significantly higher (HR: 2.81, 95 %-CI 1.49-5.30, p = 0.001, and HR: 1.92, 95 %-CI 1.29-2.87, p = 0.001), and in patients with diabetes all individual components of the main endpoint were significantly higher than in patients with normoglycemia (all p ≤ 0.001). Results were consistent after adjustment for confounders. Major bleeding rates were significantly higher in patients with prediabetes and diabetes, as compared to normoglycemia (3.9 % and 4.1 % vs. 2.3 %; HR:1.73, 95 %-CI 1.03-2.92, p = 0.040, and HR:1.78, 95 %-CI 1.23-2.57, p = 0.002). However, after adjustment for confounders, differences were no longer significant. CONCLUSIONS: Not only patients with diabetes but also patients with prediabetes represent a high-risk population. After treatment with new-generation DES, both patient groups had higher risks of ischemic and bleeding events. Differences in major bleeding were mainly attributable to dissimilarities in baseline characteristics. Routine assessment of glycemic state may help to identify patients with prediabetes for intensified management of cardiovascular risk factors. TRIAL REGISTRATION: BIO-RESORT ClinicalTrials.gov: NCT01674803, registered 29-08-2012; BIONYX ClinicalTrials.gov: NCT02508714, registered 27-7-2015.

Historical Advancements and Evolution in Understanding Human Anatomy and Pathology: The Contribution of the Middle Ages.

Dissections and autopsies are critical for understanding human anatomy, pathology, and uncovering mechanisms of disease. This review presents an historical journey from ancient times until the late Middle Ages. The major steps and developments are summarized with key figures and events presented.

Long-term outcomes of patients with chronic inflammatory diseases after percutaneous coronary intervention.

OBJECTIVE: To assess the long-term outcomes of patients with chronic inflammatory diseases who underwent percutaneous coronary intervention (PCI). METHODS: A Retrospective cohort study of all adult patients who underwent PCI in a large tertiary care center from January 2002 to August 2020. RESULTS: A total of 12,951 patients underwent PCI during the study period and were included in the cohort. The population of chronic inflammatory diseases includes 247 (1.9%) patients; 70 with inflammatory bowel disease (IBD) and 173 with autoimmune rheumatic diseases (AIRD). The composite endpoint of mortality, acute coronary syndrome (ACS) or admission due to acute heart failure was similar at 30 days and more frequent in the inflammatory disease group (42.8% in AIRD group, 35.7% in the IBD group and 29.6% in the noninflammatory group, p < 0.0001). The adjusted cox regression model found a statistically significant increased risk of the composite primary endpoints of around 40% for patients both with AIRD and IBD. Readmission due to ACS was also increases at 30 days in the AIRD group compared to the noninflammatory group (0.6% vs. 0.1%, p < 0.001) and 1 year (37.6% for the AIRD group, 34.3% in the IBD group and 25.5% in the noninflammatory group (p < 0.0001). Patients with inflammatory diseases were found to have a significantly increased risk congestive heart failure admissions at 1 year in a subgroup analysis of patients with myocardial infarction. CONCLUSION: Patients with AIRD and IBD are at higher risk for cardiovascular events in long-term follow up once diagnosed with CAD and treated with PCI.

Acute myocardial infarction treated with novel Resolute Onyx and Orsiro stents in the randomized BIONYX trial.

OBJECTIVES: To compare 2-year outcome following treatment with drug-eluting stents (DES) for acute myocardial infarction (MI) versus non-MI clinical syndromes. In acute MI patients, a stent-level comparison was performed, comparing Resolute Onyx versus Orsiro stents. BACKGROUND: In patients presenting with acute MI, higher adverse event rates have been reported. So far, no clinical results >1 year have been published of acute MI patients treated with Resolute Onyx. METHODS: This post-hoc analysis of the randomized BIONYX trial(NCT02508714) assessed the main outcome target vessel failure (TVF: cardiac death, target vessel MI, or target vessel revascularization) with Kaplan-Meier methods. RESULTS: Of all 2,488 trial participants, acute MI patients (n = 1,275[51.2%]) were significantly younger and had less comorbidities than non-MI patients (n = 1,213[48.8%]). TVF rates were lower in acute MI patients (77/1,275[6.1%] vs. 103/1,213[8.6%], HR:0.70, 95%-CI 0.52-0.94; plog-rank  = 0.02), mainly driven by target vessel revascularization (4.1 vs. 6.1%, plog-rank  = 0.03). Multivariate analysis showed no independent association of clinical syndrome with TVF (adjusted-HR: 0.81, 95%-CI 0.60-1.10; p = .17). In MI patients treated with Resolute Onyx (n = 626) versus Orsiro (n = 649), there was no difference in TVF (6.2 vs. 6.1%; plog-rank  = 0.97) and its components. There was only 1(0.2%) definite-or-probable stent thrombosis in RO-ZES and 8(1.2%) in O-SES (p = .053). CONCLUSIONS: Two years after treatment with thin-strut DES in this randomized trial, patients treated for acute MI had lower adverse event rates than non-MI patients. Yet, these findings were mainly attributable to between-group differences in patient and lesion characteristics. In patients who underwent PCI for acute MI, both Resolute Onyx and Orsiro showed favorable and similar 2-year outcomes.

First Report of 3-Year Clinical Outcome After Treatment With Novel Resolute Onyx Stents in the Randomized BIONYX Trial.

BACKGROUND: At 1 year, the international randomized BIONYX trial (ClinicalTrials.gov:NCT02508714) established non-inferiority regarding safety and efficacy of the novel Resolute Onyx zotarolimus-eluting stent (RO-ZES) vs. the Orsiro sirolimus-eluting stent (O-SES). Although the RO-ZES is used in daily practice, no clinical results have been published beyond 2 years.Methods and Results:We assessed 3-year clinical outcomes of 2,488 all-comers after percutaneous coronary intervention (PCI) with RO-ZES vs. O-SES. The main endpoint was target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction (MI), or target vessel revascularization. Time-to-endpoints was assessed by Kaplan-Meier methods and between-group comparisons by log-rank tests. Follow-up was available in 2,433/2,488 (97.8%) patients. There was no significant between-stent difference in TVF (RO-ZES 112/1,243 [9.2%] vs. O-SES 109/1,245 [8.9%], hazard ratio [HR]: 1.03, 95% confidence interval [CI] 0.79-1.34; Plog-rank=0.85) and its individual components. The all-cause mortality was significantly lower after PCI with RO-ZES (3.7% vs.5.4%, HR: 0.67, 95% CI 0.46-0.97; Plog-rank=0.034), but cardiac mortality did not differ significantly (1.1% vs.1.9%, HR: 0.56, 95% CI 0.28-1.11; Plog-rank=0.09). Definite-or-probable stent thrombosis rates were low for both groups (0.6% vs.1.2%, HR: 0.46, 95% CI 0.19-1.14; Plog-rank=0.09). CONCLUSIONS: This first 3-year randomized assessment of the RO-ZES showed a favorable rate of TVF that matched the outcomes of patients treated with O-SES. We observed a lower rate of all-cause death in the RO-ZES group, but long-term clinical follow-up is of interest.

The Degree of the Predischarge Pulmonary Congestion in Patients Hospitalized for Worsening Heart Failure Predicts Readmission and Mortality.

BACKGROUND: Prediction of readmission and death after hospitalization for heart failure (HF) is an unmet need. AIM: We evaluated the ability of clinical parameters, NT-proBNP level and noninvasive lung impedance (LI), to predict time to readmission (TTR) and time to death (TTD). METHODS AND RESULTS: The present study is a post hoc analysis of the IMPEDANCE-HF extended trial comprising 290 patients with LVEF ≤45% and New York Heart Association functional class II-IV, randomized 1:1 to LI-guided or conventional therapy. Of all patients, 206 were admitted 766 times for HF during a follow-up of 57 ± 39 months. The normal LI (NLI), representing the "dry" lung status, was calculated for each patient at study entry. The current degree of pulmonary congestion (PC) compared with its dry status was represented by ΔLIR = ([measured LI/NLI] - 1) × 100%. Twenty-six parameters recorded during HF admission were used to predict TTR and TTD. To determine the parameter which mainly impacted TTR and TTD, variables were standardized, and effect size (ES) was calculated. Multivariate analysis by the Andersen-Gill model demonstrated that ΔLIRadmission (ES = 0.72), ΔLIRdischarge (ES = -3.14), group assignment (ES = 0.2), maximal troponin during HF admission (ES = 0.19), LVEF related to admission (ES = -0.22) and arterial hypertension (ES = 0.12) are independent predictors of TTR (p < 0.01, χ2 = 1,206). Analysis of ES showed that residual PC assessed by ∆LIRdischarge was the most prominent predictor of TTR. One percent improvement in predischarge PC, assessed by ∆LIRdischarge, was associated with a likelihood of TTR increase by 14% (hazard ratio [HR] 1.14, 95% confidence interval [CI] 1.13-1.15, p < 0.01) and TTD increase by 8% (HR 1.08, 95% CI 1.07-1.09, p < 0.01). CONCLUSION: The degree of predischarge PC assessed by ∆LIR is the most dominant predictor of TTR and TTD.

Impact of malignancy on In-hospital mortality, stratified by the cause of admission: An analysis of 67 million patients from the National Inpatient Sample.

OBJECTIVE: To describe the patient characteristics and the reason for admission of patients with malignancy by malignancy, and to study mortality rates for the different causes of admissions among the different types of cancer. PATIENTS AND METHODS: Using the nationwide Inpatient Sampling (2015-2017) we examined the cause of admission and associated in-hospital mortality, stratified by presence and type of malignancy. Multivariable logistic regression models were used to examine the association between in-hospital mortality and malignancy sites for different primary admission causes. RESULTS: Out of 67 819 693 inpatient admissions, 8.8% had malignancy. Amongst those with malignancy, haematological malignancy was the most common (20.2%). The most common cause of admission amongst all cancers were malignancy-related admissions, where up to 57% of all colorectal admissions were malignancy-related. The most common non-malignancy cause of admission was infectious causes, which were most frequent among patients with haematological malignancy (18.4%). Patients with malignancy had higher crude mortality rates (5.7% vs 1.9%). Mortality rates were highest among patients with lung cancer (8.7%). Among all admissions, the adjusted rates of mortality were higher for patients with lung (OR 3.65, 95% CI [3.59-3.71]), breast (OR 2.06, 95% CI [1.99-2.13]), haematological (OR 1.79, 95% CI [1.76-1.82]) and colorectal (OR 1.71, 95% CI [1.66-1.76]) malignancies compared with patients with no malignancy. CONCLUSION: Our work highlights the need to consider the burden of cancer on our hospital services and consider how the prognostic impact of different types of admissions may relate to the type of cancer diagnosis and understand whether these differences relate to disparities in clinical care/treatments.

Trends in cardiovascular mortality of cancer patients in the US over two decades 1999-2019.

BACKGROUND: Cancer is the second most common cause of death globally after cardiovascular disease, and cancer patients are at an increased risk of CV death. This recognition has led to publication of cardio-oncological guidelines and to the widespread adoption of dedicated cardio-oncology services in many institutes. However, it is unclear whether there has been a change in the incidence of CV death in cancer patients. METHODS AND RESULTS: Using Centers for Disease Control and Prevention Wide-Ranging, Online Data for Epidemiologic Research (CDC WONDER) Multiple Cause of Death dataset, we determined national trends in age-standardised mortality rates attributed to cardiovascular diseases in patients with and without cancer, from 1999 to 2019, stratified by cancer type, age, gender, race, and place of residence (state and urbanisation status). Among more than 17.8 million cardiovascular deaths in the United States, 13.6% were patients with a concomitant cancer diagnosis. During the study period, among patients with cancer, the age-adjusted mortality rate dropped by 52% (vs 38% in patients with no cancer). In cancer patients, age-adjusted mortality rate dropped more significantly among patients with gastrointestinal, breast, and prostate malignancy than among patients with haematological malignancy (59%-63% vs. 41%). Similar reduction was observed in both genders (53%-54%), but more prominent reduction was observed in older patients and in those living in metro areas. CONCLUSIONS: Our findings emphasise the role of multidisciplinary management of cancer patients. Widespread adoption of cardio oncology services have the potential to impact the inherent risk of increased CV mortality in both cancer patients and survivors.

New-generation drug-eluting coronary stents in octogenarians: Patient-level pooled analysis from the TWENTE I-IV trials.

BACKGROUND: Patients aged ≥80 years are often treated with new-generation drug-eluting stents (DES), but data from randomized studies are scarce owing to underrepresentation in most trials. We assessed 1-year clinical outcome of octogenarians treated with new-generation DES versus younger patients. METHODS: We pooled patient-level data of 9,204 participants in the TWENTE, DUTCH PEERS, BIO-RESORT, and BIONYX (TWENTE I-IV) randomized trials. The main clinical end point was target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction (MI), or clinically indicated target vessel revascularization. RESULTS: The 671 octogenarian trial participants had significantly more comorbidities. TVF was higher in octogenarians than in 8,533 patients <80 years (7.3% vs 5.3%, hazard ratio [HR]: 1.36, 95% CI: 1.0-1.83, P = .04). The cardiac death rate was higher in octogenarians (3.9% vs 0.8%, P < .001). There was no significant between-group difference in target vessel MI (2.3% vs 2.3%, P = .88) and repeat target vessel revascularization (1.9% vs 2.8%, P = .16). In multivariate analyses, age ≥ 80 years showed no independent association with TVF (adjusted HR: 1.04, 95% CI: 0.76-1.42), whereas the risk of cardiac death remained higher in octogenarians (adjusted HR: 3.38, 95% CI: 2.07-5.52, P < .001). In 6,002 trial participants, in whom data on major bleeding were recorded, octogenarians (n = 459) showed a higher major bleeding risk (5.9% vs 1.9%; HR: 3.08, 95% CI: 2.01-4.74, P < .001). CONCLUSIONS: Octogenarian participants in 4 large-scale randomized DES trials had more comorbidities and a higher incidence of the main end point TVF. Cardiac mortality was higher in octogenarians, whereas there was no increase in MI or target vessel revascularization rates. Treatment of octogenarian patients with new-generation DES appears to be safe and effective.