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BackgroundSurgical risk prediction models are routinely used to guide decision-making for transcatheter aortic valve replacement (TAVR). New and updated TAVR-specific models have been developed to improve risk stratification; however, the best option remains unknown.ObjectiveTo perform a comparative validation study of six risk models for the prediction of 30-day mortality in TAVRMethods and resultsA total of 2946 patients undergoing transfemoral (TF,n = 2625) or transapical (TA,n = 321) TAVR from 2008 to 2018 from the German Rhine Transregio Aortic Diseases cohort were included. Six surgical and TAVR-specific risk scoring models (LogES I, ES II, STS PROM, FRANCE-2, OBSERVANT, GAVS-II) were evaluated for the prediction of 30-day mortality. Observed 30-day mortality was 3.7% (TF 3.2%; TA 7.5%), mean 30-day mortality risk prediction varied from 5.8 ± 5.0% (OBSERVANT) to 23.4 ± 15.9% (LogES I). Discrimination performance (ROC analysis,c-indices) ranged from 0.60 (OBSERVANT) to 0.67 (STS PROM), without significant differences between models, between TF or TA approach or over time. STS PROM discriminated numerically best in TF TAVR (c-index 0.66; range ofc-indices 0.60 to 0.66); performance was very similar in TA TAVR (LogES I, ES II, FRANCE-2 and GAVS-II all withc-index 0.67). Regarding calibration, all risk scoring models—especially LogES I—overestimated mortality risk, especially in high-risk patients.ConclusionsSurgical as well as TAVR-specific risk scoring models showed mediocre performance in prediction of 30-day mortality risk for TAVR in the German Rhine Transregio Aortic Diseases cohort. Development of new or updated risk models is necessary to improve risk stratification.Graphic abstract

Guidelines recommend adjunct glycoprotein IIb/IIIa inhibitors (GPIs) only in selected patients with acute ST-segment elevation myocardial infarction (STEMI). This study aimed to evaluate routine GPI use in STEMI treated with primary percutaneous coronary intervention.Online databases were searched for randomized controlled trials of routine GPI vs control therapy in STEMI. Data from retrieved studies were abstracted and evaluated in a comprehensive meta-analysis. Twenty-one randomized controlled trials with 8585 patients were included: 10 trials randomized tirofiban, 9 abciximab, 1 trial eptifibatide, and 1 trial used abciximab+tirofiban; only 1 trial used dual antiplatelet therapy with prasugrel/ticagrelor.Routine GPI use was associated with a significant reduction in all-cause mortality at 30 days (2.4% [GPI] vs 3.2%; risk ratio [RR], 0.72; P = 0.01) and 6 months (3.7% vs 4.8%; RR, 0.76; P = 0.02), and a reduction in recurrent myocardial infarction (1.1% vs 2.1%; RR, 0.55; P = 0.0006), repeat revascularization (2.5% vs 4.1%; RR, 0.63; P = 0.0001), thrombolysis in myocardial infarction flow3 after percutaneous coronary intervention (5.4% vs 8.2%; RR, 0.61; P0.0001), and ischemic stroke (RR, 0.42; P = 0.04). Major (4.7% vs 3.4%; RR, 1.35; P = 0.005) and minor bleedings (7.2% vs 5.1%; RR, 1.39; P = 0.006) but not intracranial bleedings (0.1% vs 0%; RR, 2.7; P = 0.37) were significantly increased under routine GPI.Routine GPI administration in STEMI resulted in a reduction in mortality, driven by reductions in recurrent ischemic events-however predominantly in pre-prasugrel/ticagrelor trials. Trials with contemporary STEMI management are needed to confirm these findings.

Background Contrast-induced nephropathy (CIN) is a major adverse event in patients undergoing coronary angiography. The Mehran risk model is the gold-standard for CIN risk prediction. However, its performance in comparison to more contemporary National Cardiovascular Data Registry-Acute Kidney Injury (NCDR-AKI) risk models remains unknown. We aimed to compare both in this study. Methods and results Predictions of Mehran and NCDR-AKI risk models and clinical events of CIN and need for dialysis were assessed in a total of 2067 patients undergoing coronary angiography with or without percutaneous coronary intervention. Risk models were compared regarding discrimination (receiver operating characteristic analysis), net reclassification improvement (NRI) and calibration (graphical and statistical analysis). The NCDR risk model showed superior risk discrimination for predicting CIN (NCDR c-index 0.75, 95% CI 0.72–0.78; vs. Mehran c-index 0.69, 95% CI 0.66–0.72, p NCDRvsMehran Conclusion In German patients undergoing coronary angiography, the modern NCDR risk model for predicting contrast-induced nephropathy showed superior discrimination compared to the Mehran model while showing less accurate calibration. Results for the outcome ‘need for dialysis’ were equivocal. Graphic abstract

Introduction and purpose Patient risk in non-ST-segment elevation myocardial infarction (NSTEMI) depends on clinical setting, individual patient variables and procedural characteristics. Standardized risk-adjusted periprocedural management for catheterization procedures using a Standard Operating Procedure (SOP) was investigated to evaluate associations with in-hospital clinical outcomes. Methods In 01/2018, our heart center established an SOP for coronary catheterization procedures in NSTEMI, targeting 1) standardized pre-procedural risk assessment using National Cardiovascular Data Registry (NCDR) risk models, and 2) standardized post-procedural risk-adjusted safety measures, including advanced patient monitoring (intermediate/intensive care) and use of vascular closure devices. All patients presenting with invasively-managed NSTEMI in 2018 were retrospectively evaluated for SOP-based pre-procedural risk scoring, SOP-based post-procedural management and in-hospital clinical outcomes of mortality, major bleeding (MB, according to BARC ≥3) and acute kidney injury (AKI, according to KDIGO). Results A total of 430 patients (age 72±12 years, 71% male, BMI 27±5) presenting with NSTEMI from 01 to 12/2018 were included, 9.8% presented in cardiogenic shock and 4.7% had suffered a preclinical cardiac arrest. Overall in-hospital mortality was 3.7%, MB occurred in 6.5%. 207 patients (48.1%, SOP+ group) had received both 1) pre-procedural risk assessment and 2) post-procedural risk-adjusted safety measures; the other 223 patients (51.9%, SOP- group) had not received either 1) or 2). There were no significant differences in baseline characteristics and prior-existing medical conditions between groups, however, significantly more patients in SOP- group were treated in emergency settings (39.9% vs. 21.7%, p=0.004). However, significantly more patients in SOP- were treated in emergency settings at higher risk (39.9% (SOP-) vs. 21.7% (SOP+); p Conclusion Standardized risk management in invasively managed NSTEMI was associated with significantly lower rates of in-hospital major bleedings. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): Junior Clinician Scientist Track, Medical faculty, Heinrich-Heine-University Düsseldorf, Germany

Background Iron is essential to the mitochondrial energy production in cardiomyocytes and its depletion is negatively associated with symptoms, functional capacity, quality of life and outcomes in patients with heart failure – independent of anemia. The relevance of iron deficiency in adults with congenital heart disease however has not been evaluated to date, and we thus aimed to evaluate it in an all-comer cohort of patients with congenital heart disease in correlation with symptoms and functional capacity. Methods and results 527 patient cases from one referral center over 2 years were evaluated concerning their iron status, anemia, functional capacity and ejection fraction of their systemic ventricle. 264 were female, 94 had a shunt lesion, 96 had left-sided obstructive lesions, 181 right-sided lesions, while 108 were considered to have complex lesions and 28 were cyanotic. The median age was 34 years, the mean BMI was 25.2±5 kg/m2, 429 patients had a normal ejection fraction and 34 moderately and severely depressed. 35 patients were classified as NYHA III, and 56 as NYHA II, while their functional capacity was evaluated via cardiopulmonary testing with a mean VO2max/kg of 22.6±6.5 and mean 69±17% of the expected. The mean serum iron concentration was 99.4±42.3 mcg/dL, their mean transferrin saturation was 27.36±13%, the mean ferritin concentration was 130.8±185 ng/mL, the mean soluble transfer factor was 1.3±0.66 mg/l and their mean Hemoglobin 14.8±2 mg/dL, while the mean MCV was 88±5.3 and the mean MCHC 33.7±1.4. 40 patients were anemic according to the WHO definition for anemia, in 28 of those patients that was already known. Iron deficiency according to stratified according to ferritin was present in 53 patients. However, when stratified according to the heart failure guidelines definition for iron deficiency 299 patients were found affected. Using the soluble transferrin receptor (sTfR) and sTfR-ferritin index iron deficiency was suspected in 10 additional individuals. Iron deficiency was associated with the ejection fraction (p=0.0001) - patients with moderately or severely depressed systemic ventricular function more often were diagnosed with iron deficiency (p=0.007)-, while it did not correlate with functional NYHA classification (p=0.622) or functional capacity (p=0.1 and 0.057). Iron deficiency was also not found significantly different amongst congenital defects but did correlate with all laboratory iron studies. Conclusions In this ambulatory population of adults with congenital heart disease we found an association of ejection fraction with iron deficiency, however no association of iron deficiency with functional capacity. The question arising is if a new definition of iron deficiency anemia in congenital heart disease similar to heart failure would be of clinical value. Funding Acknowledgement Type of funding source: None

Background Uninterrupted anticoagulation during catheter ablation of atrial fibrillation (CAAF) became standard of care after positive results of trials investigating vitamin K antagonists (VKA). Previous studies and meta-analyses of uninterrupted direct oral anticoagulants (DOAC) vs. VKA have given controversial results. We thus aimed to elucidate the risks and benefits of uninterrupted DOAC vs. VKA during CAAF in an updated meta-analysis of randomized controlled trials (RCTs). Methods Online databases were searched for RCTs comparing uninterrupted DOAC to VKA in patients undergoing CAAF until September 2019. Data from retrieved studies were analysed in a comprehensive meta-analysis. Primary safety outcome was major bleeding; primary efficacy outcome was stroke or transient ischemic attack (TIA). Secondary outcomes included a composite of major bleeding and stroke or TIA, minor bleeding, acute cerebral lesions on magnetic resonance imaging (ACL) and mortality. Results Six eligible RCTs comprising 2,369 patients were included. Pooled meta-analysis showed no significant differences in DOAC vs. VKA concerning the rates of major bleeding (2.2% vs. 3.8%; odds ratio (OR) 0.69, 95% confidence interval (CI) 0.30–1.56; p=0.37) and stroke or TIA (0.2% vs. 0.2%; OR 0.97, CI 0.20–4.72; p=0.97). There were no significant differences found in secondary outcomes (OR 0.73, p=0.49 for composite of major bleeding and stroke or TIA; OR 1.08, p=0.52 for minor bleeding; OR 1.12, p=0.59 for ACL; and OR=0.60, p=0.64 for all-cause mortality). Conclusion Our meta-analysis suggests that uninterrupted periprocedural anticoagulation with DOAC or VKA is characterized by a similar risk/benefit ratio in patients undergoing CAAF with comparable rates of major bleeding and stroke. Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): Medical faculty of the Heinrich-Heine-University Düsseldorf, Germany

Background: Periprocedural uninterrupted anticoagulation for catheter ablation of atrial fibrillation (AF) became standard after positive results of vitamin K antagonist (VKA) trials. Previous studies of uninterrupted direct oral anticoagulants (DOACs) vs. VKA have given controversial results. We thus aimed to elucidate the risk/benefit ratio of uninterrupted DOAC vs. VKA during catheter ablation of AF in an updated meta-analysis of randomised controlled trials (RCTs). Methods: Online databases were searched for RCTs comparing uninterrupted DOAC to VKA in patients undergoing catheter ablation of AF. Data from retrieved studies were analysed in a comprehensive meta-analysis. Primary safety outcome was major bleeding; primary efficacy outcome was stroke or transient ischaemic attack (TIA). Secondary outcomes included a composite of major bleeding and stroke or TIA, minor bleeding, acute cerebral lesions on magnetic resonance imaging (MRI), and mortality. Results: Six eligible RCTs comprising 2,369 patients were included. There were no significant differences in DOAC vs. VKA concerning the rates of major bleeding (2.2% vs. 3.8%; odds ratio (OR) 0.69, 95% confidence interval (CI) 0.30–1.56; p = .37) and stroke or TIA (0.2% vs. 0.2%; OR 0.97, CI 0.20–4.72; p = .97). Pooled meta-analysis of secondary outcomes revealed no significant differences (OR 0.73, p = .49 for composite of major bleeding and stroke or TIA; OR 1.08, p = .52 for minor bleeding; OR 1.12, p = .59 for acute cerebral lesions on MRI; and OR 0.60, p = .64 for all-cause mortality). Conclusion: Our meta-analysis suggests that uninterrupted DOAC is not superior to VKA in patients undergoing catheter ablation of AF with comparable rates of major bleeding and stroke.

Background Cardiovascular guidelines recommend adjunct glycoprotein IIb/IIIa inhibitors (GPI) only in selected patients with acute ST-segment elevation myocardial infarction (STEMI). Purpose This study aimed to evaluate routine GPI use in STEMI treated with primary PCI. Methods Online databases were systematically searched for randomised controlled trials (RCTs) of routine GPI vs. control therapy in STEMI. Data from retrieved studies were abstracted and evaluated in a comprehensive meta-analysis using Mantel-Haenszel estimates of risk ratios (RR) as summary statistics. Results After systematic review, twenty-one RCTs with 8,585 patients were included: ten trials randomized tirofiban (T), nine abciximab (A), one eptifibatide (E), one trial used A+T; only one trial used DAPT with prasugrel/ ticagrelor. Routine GPI were associated with a significant reduction in all-cause mortality at 30 days (2.4% (GPI) vs. 3.2%; risk ratio (RR) 0.72; p=0.01) and 6 months (3.7% vs. 4.8%; RR 0.76; p=0.02), and a reduction in recurrent MI (1.1% vs. 2.1%; RR 0.55; p=0.0006), repeat revascularization (2.5% vs. 4.1%; RR 0.63; p=0.0001), TIMI flow Conclusions Routine GPI administration during primary PCI in STEMI resulted in mortality reduction, driven by reductions in recurrent ischemic events – however predominantly in trials pre-prasugrel/ticagrelor. Trials in contemporary STEMI management are needed to confirm these findings.

Background and purpose EuroSCORE (ES) and Society of Thoracic Surgeons (STS) risk prediction models are routinely used to guide decision-making for transcatheter aortic valve replacement (TAVR), however their accuracy remains limited, especially in very old and high-risk patients. New and updated scoring models have thus been developed to improve risk stratification. We performed a comparative evaluation of classical and new risk scoring models for prediction of 30d mortality in transcatheter aortic valve interventions. Methods and results A total of 1,569 patients undergoing transfemoral (TF, n=1.235) or transapical (TA, n=334) TAVR from 2009 to 2018 were included in a single-center all-comer analysis. Six risk scoring models (logES_I, ES_II, STS-PROM, FRANCE-2, OBSERVANT, GAV-2) were calculated for all patients and evaluated for prediction of 30d mortality in their model discrimination (c-indices with 95% confidence intervals (CI)) and calibration (graphical evaluation). Mean classical risk scores confirmed an intermediate-to-high-risk patient collective (logES_I 27.0±16.9%; STS-PROM 7.0±6.4%), mean 30-day mortality was 3.4% (TF 2.3%; TA 7.8%). Overall discrimination performance was best in FRANCE-2 (c-index 0.73, 95% CI 0.67–0.80), followed by STS-PROM (c-index 0.68, 95% CI 0.62–0.75), OBSERVANT (c-index 0.68, 95% CI 0.61–0.76), ES_II (c-index 0.64) and logES_I and GAV-2 (both c-indices 0.63). FRANCE-2 discriminated best in TF TAVR (c-index 0.72; range of c-indices 0.63 to 0.72), while OBSERVANT performed best in TA TAVR (c-index 0.70; range of c-indices 0.61 to 0.70). All risk scoring models – with the exception of lowest-risk deciles of STS-PROM and ES_II – showed an overestimation of mortality probability in all risk strata. Conclusion FRANCE-2 and OBSERVANT risk models showed superior discrimination performance to classical risk scoring models in TF and TA TAVR, however all models tended to overestimate mortality probability.

Background and purpose Although endovascular thrombectomy (EVT) in acute ischemic stroke (AIS) is guideline-recommended to improve functional recovery, thus far there are only inconclusive data from underpowered singular trials of EVT vs. medical therapy (MT) on mortality. We here aimed to perform a meta-analysis on short-term mortality in guideline-relevant EVT vs. MT randomized controlled trials (RCTs). Methods All randomized controlled trials (RCT) reporting EVT vs. MT in the latest 2018 American Stroke Association/American Heart Association (ASA/AHA) Guidelines were eligible for inclusion. Data were abstracted by two independent investigators and double-checked by four others. Study data were integrated using the Cochran-Mantel-Haenszel method and a random-effects model to compute summary statistics of risk ratios (RR) with 95% confidence intervals (CI). Ninety-day mortality and intracranial hemorrhage (ICH) were analyzed. Results Ten of the twelve guideline-relevant EVT vs. MT RCTs (DAWN, DEFUSE 3, ESCAPE, EXTEND-IA, MR CLEAN, MR RESCUE, REVASCAT, SWIFT PRIME, THERAPY, THRACE) with 2,313 patients were selected for inclusion. Studies IMS III and SYNTHESIS were excluded due to their very infrequent use of EVT. Stent retrievers (Trevo, Solitaire, Merci) were most frequently applied, followed by thrombus aspiration (Penumbra). Intravenous thrombolysis was administered in addition to EVT in the majority of patients. In the pooled meta-analysis of all eligible RCTs, EVT significantly reduced the risk for 90-day mortality by 3.7% compared to MT (15.0% vs. 18.7%; RR 0.81 with CI 0.68 to 0.98; p=0.03), accounting for a number-needed-to-treat of 27 to prevent one all-cause death. Trends were similar in early-window (RR 0.83) and late-window trials only (RR 0.76). There was no difference in the risk for ICH in EVT vs. MT (4.2% vs. 4.0%; RR 1.11 with CI 0.71 to 1.72; p=0.65). All included trials were published in high-quality journals and risk of bias was judged low. Conclusions This meta-analysis lends evidence to EVT benefits for survival already during the first 90 days after acute ischemic stroke. These results further highlight the evolution of interventional techniques in this setting.

The National Cardiovascular Data Registry (NCDR) risk scores for mortality, bleeding and acute kidney injury (AKI) are accurate outcome predictors of coronary catheterization procedures in North American populations. However, their application in German clinical practice remained elusive and we thus aimed to verify their use. NCDR scores for mortality, bleeding and AKI and corresponding clinical outcomes were retrospectively assessed in patients undergoing catheterization for ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI) or for elective coronary procedures at a German Heart Center from 2014 to 2017. Risk model performance was assessed using receiver-operating-characteristic curves (discrimination) and graphical analysis/logistic regression (calibration). A total of 1637 patients were included, procedures were performed for STEMI (565 patients, 34.5%), NSTEMI (572 patients, 34.9%) and elective purposes (500 patients, 30.5%); 6% (13% of STEMI and 5% of NSTEMI patients) presented in cardiogenic shock and 3% with resuscitated cardiac arrest. Radial access was used in 38% of procedures and cross-over was necessary in 5%; PCI was performed in 60% of procedures. In-hospital mortality was 6.3% (STEMI 14.5%; NSTEMI 3.7%; elective 0%) and major bleedings occurred in 5.6% (STEMI 10.6%; NSTEMI 5.4%; elective 0.2%); AKI was detected in 18.1% of patients (STEMI 23.7%; NSTEMI 27.3%; elective 1.4%), amounting to KDIGO stage I/II/III in 11.5%/3.5%/3.2%. NCDR risk models discriminated very well for mortality [AUC 0.93 with 95% confidence interval (CI) 0.91–0.95] and well for major bleeding (AUC 0.82, CI 0.78–0.86) and any AKI (AUC 0.83, CI 0.81–0.86). Discrimination in the subgroup of patients with PCI was comparable (mortality: AUC 0.90; major bleeding: AUC 0.78; any AKI: AUC 0.79). However, calibration showed considerable underestimation of mortality and AKI in high-risk patients, while major bleeding was consistently overestimated (Hosmer–Lemeshow p