Differences in diagnostication, and revascularisation of ischaemic heart disease in Western Denmark.

INTRODUCTION: In Denmark, the incidence of and mortality from ischaemic heart disease (IHD) has been declining. In this context, it is of interest to assess any regional differences in diagnostication and invasive treatment of IHD. METHODS: We intended to describe the diagnostication and invasive treatment of IHD in Western Denmark at the regional/municipal level using the Western Denmark Heart Registry. Coronary angiography (CAG), percutaneous coronary intervention (PCI) and coronary arterial bypass grafting were registered from 2000 through 2019; cardiac multislice computed tomography (CMCT), from 2015 through 2019. RESULTS: Concerning the use of revascularisation for acute coronary syndrome (ACS), we found comparable regional activity levels but significant differences between individual municipalities. Furthermore, the use of CAG for chronic coronary syndrome (CCS) was significantly higher and the use of CMCT significantly lower in the North Denmark Region than in the Central and South Denmark Regions. CONCLUSION: We found differences in the rates of PCI for ACS at the municipal level but not between the Western Denmark regions. Furthermore, at the regional level, evaluation of chronic IHD differed regarding use of elective CAG and CMCT, and use of CMCT was not paralleled by a reduction in the number of CAG procedures. This may possibly prompt discussions on the strategy for invasive and non-invasive diagnosis of CCS and on targeted preventive measures. FUNDING: none TRIAL REGISTRATION. not relevant.

International randomized trial on the effect of revascularization or optimal medical therapy of chronic total coronary occlusions with myocardial ischemia - ISCHEMIA-CTO trial - rationale and design.

BACKGROUND: Chronic total occlusions (CTO) are frequent among patients with coronary artery disease. Revascularization with percutaneous coronary intervention (PCI) is safe and feasible in experienced hands. However, randomized data are needed to demonstrate symptomatic as well as prognostic effect of CTO-PCI compared to optimal medical therapy alone. METHODS: This trial aims to evaluate the effect of CTO PCI in patients with a CTO lesion and target vessel diameter ≥ 2.5 mm, and myocardial ischemia in the relevant territory. First, all patients are subjected to optimal medical therapy (OMT) for at least for 3 months and non-CTO lesions are managed according to guidelines. Subsequently, prior to randomization myocardial ischemia and quality of life (Seattle Questionnaire (SAQ)) is assessed. Patients are divided into two cohorts based on their SAQ score and randomized to either OMT alone or OMT and CTO-PCI. Cohort A is defined as Low- or asymptomatic patients with a quality-of-life score > 60 and/or CCS class < 2, and more than 10 % ischemia in the left ventricle (LV). Cohort B is symptomatic patients with a quality-of-life score < 60 or CCS class angina > 1 and at least ischemia in 5% of the LV. The primary end-point in cohort A is a composite of major adverse cardiac and cerebral events, hospitalization for heart failure and malignant ventricular arrhythmias. The primary endpoint in cohort B is difference in quality of life 6 months after randomization. IMPLICATIONS: This trial is designed to investigate if CTO-PCI improves QoL and MACCE. Both positive and negative outcome of the trial will affect future guidelines and recommendations on how to treat patients with CTO.

Soluble ST2 in plasma is associated with post-procedural no-or-slow reflow after primary percutaneous coronary intervention in ST-elevation myocardial infarction.

AIM: The no-or-slow-reflow phenomenon after primary percutaneous coronary intervention is associated with more extensive myocardial injury in patients with ST-elevation myocardial infarction (STEMI). Soluble suppression of tumourigenicity 2 (sST2) is released in acute myocardial response to injury, and an increase in plasma level in the initial phase of STEMI is associated with increased mortality and risk of heart failure. We have therefore explored the association of pre-intervention plasma sST2 with the post-procedural no-or-slow-reflow phenomenon in patients with STEMI. METHODS AND RESULTS: We included consecutive patients with verified STEMI from two tertiary heart centres. Blood samples were collected at admission before angiography. Post-procedural coronary flow was assessed according to thrombolysis in myocardial infarction (TIMI) classification for STEMI. Patients were divided into two groups: post-procedural TIMI 0-2 as no-or-slow reflow and TIMI 3 as normal reflow. The association between sST2 and TIMI flow was explored using multiple logistic regression. A total of 1607 patients with available TIMI flow classification were included in the analysis. Normal reflow was seen in 1520 (94.6%), while 87 (5.4%) had no-or-slow reflow. No-or-slow-reflow patients had higher all-cause 30-day mortality [10 (11%) vs. 65 (4.3%), P = 0.006]. Pre-procedural sST2 was higher in the no-or-slow-flow group [47 ng/mL, interquartile range (IQR, 33-83) vs. 39 ng/mL (IQR 29-55), P < 0.001] and was independently associated with post-procedural no-or-slow flow [two-fold sST2 increase: odds ratio 1.44 (1.15-1.78), P = 0.0012]. CONCLUSION: In patients with STEMI, the sST2 level at admission before coronary angiography is independently associated with the post-procedural no-or-slow-reflow phenomenon.

Impact of Smoking Status on Mortality in STEMI Patients Undergoing Mechanical Reperfusion for STEMI: Insights from the ISACS-STEMI COVID-19 Registry.

The so-called "smoking paradox", conditioning lower mortality in smokers among STEMI patients, has seldom been addressed in the settings of modern primary PCI protocols. The ISACS−STEMI COVID-19 is a large-scale retrospective multicenter registry addressing in-hospital mortality, reperfusion, and 30-day mortality among primary PCI patients in the era of the COVID-19 pandemic. Among the 16,083 STEMI patients, 6819 (42.3%) patients were active smokers, 2099 (13.1%) previous smokers, and 7165 (44.6%) non-smokers. Despite the impaired preprocedural recanalization (p < 0.001), active smokers had a significantly better postprocedural TIMI flow compared with non-smokers (p < 0.001); this was confirmed after adjustment for all baseline and procedural confounders, and the propensity score. Active smokers had a significantly lower in-hospital (p < 0.001) and 30-day (p < 0.001) mortality compared with non-smokers and previous smokers; this was confirmed after adjustment for all baseline and procedural confounders, and the propensity score. In conclusion, in our population, active smoking was significantly associated with improved epicardial recanalization and lower in-hospital and 30-day mortality compared with previous and non-smoking history.

Risk of Myocardial Infarction and Death After Noncardiac Surgery Performed Within the First Year After Coronary Drug-Eluting Stent Implantation for Acute Coronary Syndrome or Stable Angina Pectoris.

This study aimed to examine the 30-day risk of myocardial infarction (MI) and death in patients who underwent noncardiac surgery within 1 year after coronary drug-eluting stent implantation for acute coronary syndrome (ACS) or stable angina pectoris (SAP) and to compare it with the risk in surgical patients without known coronary artery disease. Patients with drug-eluting stent implantation for ACS (n = 2,291) or SAP (n = 1,804) who underwent noncardiac surgery were compared with a cohort from the general population without known coronary artery disease matched on the surgical procedure, hospital contact type, gender, and age. In patients with ACS, the 30-day MI risk was markedly increased when surgery was performed within 1 month after stenting (10% vs 0.8%; adjusted odds ratio [ORadj] 20.1, 95% confidence interval [CI] 8.85 to 45.6), whereas mortality was comparable (10% vs 8%, ORadj 1.17, 95% CI 0.76 to 1.79). When surgery was performed between 1 and 12 months after stenting, the 30-day absolute risk for MI was low but higher than in the comparison cohort (0.6% vs 0.2%, ORadj 2.18, 95% CI 0.89 to 5.38), whereas the mortality risks were similar (2.0% vs 1.8%, ORadj 1.03, 95% CI 0.69 to 1.55). In patients with SAP, the 30-day MI risk was low but higher than in the comparison cohort (0.4% vs 0.2%, ORadj 1.90, 95% CI 0.70 to 5.14), whereas the mortality risks were similar (2.2% vs 2.1%, ORadj 0.91, 95% CI 0.61 to 1.37). In conclusion, patients with ACS and SAP who underwent surgery between 1 and 12 months after stent implantation had a risk for MI and death that was similar to the risk observed in surgical patients without coronary artery disease.

Neutrophil Gelatinase-Associated Lipocalin (NGAL) Measured at Admission is Associated With Development of Late Cardiogenic Shock and Mortality in Patients With ST-Segment Elevation Myocardial Infarction.

ABSTRACT: In patients with ST-elevation myocardial infarction (STEMI) the immune system is activated with an inflammatory response to follow. In STEMI patients with a severe inflammatory response, risk of development of cardiogenic shock (CS) seems increased. Neutrophil Gelatinase-Associated Lipocalin (NGAL) is a glycoprotein released from mature neutrophils and plasma concentration may increase immediately after STEMI. We therefore aimed to assess whether admission NGAL plasma concentration in patients with STEMI was associated with CS development after leaving the catheterization laboratory (late CS) and 30-day all-cause mortality. PATIENTS AND METHODS: From 1,892 consecutive patients with STEMI 1,626 (86%) had plasma NGAL concentration measured upon hospital admission before angiography throughout a 1-year period at two tertiary heart centers in Denmark. Patients were stratified according to NGAL quartiles (Q1-4). To assess late CS development, we adjusted for the Observatoire Régional Breton sur l'Infarctus risk score for late CS. For mortality assessment, we adjusted for gender, age, post-PCI culprit Thrombolysis in myocardial infarction flow, left ventricular ejection fraction (LVEF), kidney dysfunction, and being comatose after cardiac arrest. RESULTS: Increasing NGAL concentration was associated with higher age, more comorbidities, and more critical patient conditions including lower blood pressure and LVEF. When adjusted for factors associated with poor outcome, NGAL remained independently associated with both late CS development (Q4 vs. Q1-3) (OR (95% CI) 3.64 (1.79-7.41) and 30-day mortality (HR (95% CI) 3.18 (1.73-5.84)). CONCLUSION: Admission plasma concentration of NGAL in STEMI patients is independently associated with 30-day all-cause mortality and predictive of late CS development.

Health-Related Quality of Life and Angina in Fractional Flow Reserve- Versus Angiography-Guided Coronary Artery Bypass Grafting: FARGO Trial (Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization).

BACKGROUND: In coronary artery bypass grafting (CABG), the use of fractional flow reserve (FFR) is insufficiently investigated. Stenosis assessment usually relies on visual estimates of lesion severity. This study evaluated health-related quality of life (HRQoL) and angina after FFR- versus angiography-guided CABG. METHODS: One hundred patients referred for CABG were randomized to FFR- or angiography-guided CABG. In the FFR group, lesions with FFR>0.80 were deferred, while the surgeon was blinded to the FFR values in the angiography group. Before and 6 months after CABG, HRQoL was assessed by the health state classifier EQ-5D of the EuroQoL 5-level instrument and angina status based on the Canadian Cardiovascular Society classification system were registered. RESULTS: Six-month angiography included FFR evaluations of deferred lesions. In total, completed EQ-5D of the EuroQoL 5-level instrument questionnaires were available in 86 patients (43 in the FFR versus 43 in the angiography-guided group). HRQoL was significantly improved and angina significantly decreased from baseline to 6 months after CABG with no difference between the randomization groups. Graft failure rates and clinical outcomes were similar in both groups. Patients with graft failure or FFR<0.80 of the previous deferred lesions had significantly lower visual analogue scale scores (78.7±14.2 versus 86.8±14.7, P=0.004) and more angina compared with patients without graft failure or FFR≥0.80 at 6-month follow-up. CONCLUSIONS: FFR- versus angiography-guided CABG demonstrated similar improvements in HRQoL and angina 6 months after CABG. Graft failure or low FFR in deferred lesions were associated with low HRQoL and angina. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02477371.

Culprit lesion morphology in patients with ST-segment elevation myocardial infarction assessed by optical coherence tomography.

AIMS: This study sought to evaluate the incidence of ruptured plaques and nonruptured plaques (NRP) and to compare patient characteristics and detailed plaque morphology features between the two culprit types in ST-segment elevation myocardial infarction (STEMI) patients, using optical coherence tomography (OCT). METHODS AND RESULTS: Using OCT, the culprit lesions in patients with STEMI were assessed prior to stent implantation. The culprit lesion was categorized as ruptured plaques or NRP, and the plaque components were evaluated. Fifty-two patients (69.3%) presented with ruptured plaques and 23 (30.7%) with NRP. Patients with NRP were younger (58.0 ± 10.4 vs 64.7 ± 9.9 years, P = 0.01) and more often smokers (72.7% vs 37.1%, P = 0.001), compared to ruptured plaques. NRP contained significantly more fibrotic plaque (20.0% [interquartile range (IQR) 13.7-29.8] vs 11.3% [IQR 6.9-18.1], P = 0.005), but less lipidic plaque (44.0% ± 13.7 vs 59.3% ± 13.6, P < 0.001), less superficial [5.0% (IQR 2.8-7.5) vs 8.1% (IQR 5.7-11.0), P = 0.005] and profound macrophages [0.9% (IQR 0.0-1.7) vs 2.2% (IQR 0.9-4.7), P = 0.003]. The prevalence, numbers and lengths of thin-cap fibroatheroma (TCFA) were significantly lower in NRP, compared to ruptured plaques [47.8% vs 88.5%, 0 (IQR 0-1) vs 1 (IQR 1-2) and 0 mm (IQR 0-2.7) vs 4.5 mm (IQR 2.3-7.7), P < 0.001]. CONCLUSIONS: One-third of STEMI patients had culprit lesions without an OCT-detectable ruptured plaque. Culprit lesions with NRP contained less vulnerable plaque components, such as lipid plaque, TCFAs and macrophages compared to ruptured plaques.

The association between self-reported health status and adverse events: a comparison among coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI).

PURPOSE: While several studies have investigated clinical outcomes following coronary artery bypass grafting (CABG) vs. percutaneous coronary intervention (PCI), studies investigating self-reported health and the association with adverse outcomes are limited. Thus, the aim was to investigate differences in health-related quality of life (HRQoL), anxiety and depression at discharge and the association with a composite endpoint of the first event of acute cardiac readmission, revascularisation or 1-year mortality among patients undergoing CABG vs. PCI. METHODS: Data from the national cohort study, DenHeart, were used, including measures of HRQoL; EuroQoL-5D-5L (EQ-5D Index Score and VAS) and HeartQoL (Global, Physical and Emotional), anxiety and depression (Hospital Anxiety and Depression Scale, HADS) and register-based follow-up. A total of 7000 patients were included (CABG n = 652, PCI n = 6348) (median age 65, 75% men). Cox Proportional Hazard models were performed among a propensity-matched population of responders (n = 520). RESULTS: HRQoL was significantly better among patients undergoing PCI vs. CABG, but with no differences in time to readmission or revascularisation. HRQoL, anxiety and depression were significantly associated with the risk of the composite endpoint among the PCI group (Hazard Ratio, HR (95% confidence intervals, CI) [EQ-5D index score 3.07 (1.67-5.67), EQ-5D VAS 0.97 (0.96-0.99), HeartQol Global 0.61 (0.38-0.95), HeartQol Emotional 0.56 (0.39-0.80), HADS-D ≥ 8 3.12 (1.61-6.01), HADS-A ≥ 8 2.08 (1.14-3.80)]. CONCLUSION: Patients undergoing PCI reported better HRQoL at discharge compared with patients undergoing CABG, whereas readmission rates were similar. Self-reported health was associated with the risk of adverse events among patients undergoing PCI, but not among patients undergoing CABG. CLINICAL TRIAL REGISTRATION: NCT01926145.

A Novel Model for Prediction of Thromboembolic and Cardiovascular Events in Patients Without Atrial Fibrillation.

Patients without atrial fibrillation (AF) constitute approximately 75% of patients suffering thromboembolism and major adverse cardiovascular events (MACE), but evidence supporting risk stratification in these patients is sparse. We aimed to develop a risk prediction model for identification of patients without AF at high risk of first-time thromboembolic events. We included 72,381 coronary angiography patients without AF and without previous ischemic stroke or transient ischemic attack. The cohort was randomly divided into a derivation cohort (80%, n = 57,680) and a validation cohort (20%, n = 14,701). The primary thromboembolic end point was a composite of ischemic stroke, transient ischemic attack, and systemic embolism. MACE was defined as a composite of cardiac death, myocardial infarction, and ischemic stroke. The final model was compared with 2 validated clinical risk models (CHADS2 and CHA2DS2-VASc). The risk prediction model assigned 1 point to heart failure, hypertension, diabetes mellitus, renal disease, age 65 to 74 years, active smoking, and multivessel obstructive coronary artery disease, and 2 points to age ≥75 years and peripheral artery disease. A C-index of 0.66 (95% CI 0.64 to 0.69) for prediction of the composite thromboembolic end point was found in the validation cohort, which was higher than for CHADS2 (C-index 0.63 [95% CI 0.60 to 0.67]; p < 0.001) and CHA2DS2-VASc (C-index 0.64 [95% CI 0.62 to 0.67]; p = 0.034). The model also predicted MACE (C-index 0.71 [95% CI 0.69 to 0.73]). In conclusion it is possible to identify patients without AF at high risk of first-time thromboembolic events and MACE by use of a simple clinical prediction model.

15O-Water Positron Emission Tomography of Myocardial Ischemia in Patients Referred for Percutaneous Coronary Intervention.

The diagnostic accuracy of non-invasive diagnostic methods for detecting coronary artery disease has increased in recent years. This study aimed to assess the diagnostic performance of 15O-water positron emission tomography (PET) in terms of stress myocardial blood flow (MBF) and myocardial flow reserve (MFR) in patients with single-vessel disease referred for percutaneous coronary intervention (PCI), using fractional flow reserve (FFR) value of ≤0.80 as the reference for a significant stenosis. We also assessed the influence of the index of microcirculatory resistance (IMR) on the diagnostic performance of PET. 15O-water PET FFR and IMR were measured before PCI in 26 patients with single-vessel disease. Stress MBF < 2.5 ml/min/g (95% confidence interval [CI]) had sensitivity 78% (95% CI: 52%-94%), specificity 50% (95% CI: 16%-84%), positive predictive value (PPV) 78% (95% CI: 63%-88%), negative predictive value (NPV) 50% (95% CI: 25%-75%), and accuracy 69% (95% CI: 48%-86%). MFR < 2.5 had sensitivity 72% (95% CI: 47%-90%), specificity 75% (95% CI: 35%-97%), PPV 87% (95% CI: 65%-96%), NPV 55% (95% CI: 34%-74%), and accuracy 73% (95% CI: 52%-88%). In patients with IMR > 24, stress MBF correlated with FFR (r = 0.651; p = 0.016) whereas stress MBF did not correlate with FFR in patients with IMR < 24. In conclusion, stress MBF and MFR had modest diagnostic performance compared to invasive FFR measurements in patients with single-vessel disease.

Smoking is the dominating modifiable risk factor in younger patients with STEMI.

AIMS: Smoking is an important modifiable risk factor for myocardial infarction. It is unclear whether smoking habits at the time of an incident ST-segment elevation myocardial infarction (STEMI) differ across age groups and sex. METHODS AND RESULTS: We included patients with incident STEMI registered in the Western Denmark Heart Registry from 2005 to 2015 (n=9914). Patients were divided into four age groups (30-49, 50-59, 60-69 and ⩾70 years) with the latter serving as reference. Smoking was the most prevalent modifiable risk factor in 30-49-year-old patients (74% vs. hypertension 15%, hyperlipidaemia 10% and diabetes 7%). The smoking prevalence decreased with increasing age, while treatment for hypertension, hyperlipidaemia and diabetes increased with increasing age. Smoking was five times (odds ratio (OR) 5.15; 95% confidence interval (CI) 4.37-6.07) more prevalent among 30-49-year-old patients with STEMI than the reference group. Differences according to sex were significant as the OR for current smoking in women was 9.88 (95% CI 6.94-14.08) compared to OR 3.78 (95% CI 3.12-4.58) in men. CONCLUSIONS: Despite public information campaigns and general warnings, smoking remains the most prevalent modifiable risk factor in younger patients with STEMI.

Validation of the European Society of Cardiology and European Society of Anaesthesiology non-cardiac surgery risk score in patients treated with coronary drug-eluting stent implantation.

Aims: The current guidelines from the European Society of Cardiology and European Society of Anaesthesiology on non-cardiac surgery (ESC/ESA-NCS) divide surgical procedures into those associated with low risk (<1%), intermediate risk (1-5%), and high risk (>5%) of major adverse cardiac events (MACE). Evaluating surgical risk might be particularly appropriate in patients with recent stent implantation, and thus we validated the ESC/ESA-NCS classification in patients undergoing NCS within 1 year after coronary drug-eluting stent (DES) implantation. Methods and results: By record-linking the Western Denmark Heart Registry and the Danish National Patient Registry, we identified 4046 patients, who underwent NCS between 1 and 12 months after DES implantation. Primary outcomes were MACE [cardiac death and myocardial infarction (MI)] and a combined endpoint of mortality and MI within 30 days after surgery. Both MACE (low risk 0.6%, intermediate risk 1.2%, and high risk 3.4%) and the combined endpoint of mortality and MI (1.5%, 4.6%, and 14.9%) were associated with the ESC/ESA-NCS classification. As compared with low-risk surgery, the odds ratios (OR) for MACE were 1.9 [95% confidence interval (CI) 0.9-4.1] for intermediate-risk surgery and 5.8 (95% CI 1.7-20.1) for high-risk surgery. For the combined endpoint of mortality and MI, the OR's were 3.1 (95% CI 2.1-4.7) for intermediate-risk surgery and 11.3 (95% CI 5.9-21.9) for high-risk surgery. Conclusion: The ESC/ESA-NCS classification is a valid tool to predict the risk of both MACE and the combined endpoint of mortality and MI for patients undergoing NCS.

Fractional Flow Reserve Versus Angiographically-Guided Coronary Artery Bypass Grafting.

BACKGROUND: The value of fractional flow reserve (FFR) evaluation of coronary artery stenosis in coronary artery bypass grafting (CABG) is uncertain, and stenosis assessments usually rely on visual estimates of lesion severity. OBJECTIVES: This randomized clinical trial evaluated graft patency and clinical outcome after FFR-guided CABG versus angiography-guided CABG. METHODS: A total of 100 patients referred for CABG were randomly assigned to FFR-guided or angiography-guided CABG. Based on the coronary angiogram, a heart team made a graft plan for all patients, and FFR evaluations were performed. In FFR-guided CABG, coronary lesions with FFR >0.80 were deferred, and a new graft plan was designed accordingly, whereas the surgeon was blinded to the FFR values in patients who underwent angiography-guided CABG. The primary endpoint was graft failure in the percentage of all grafts after 6 months. RESULTS: Angiographic follow-up at 6 months was available for 72 patients (39 vs. 33 in the FFR-guided and angiography-guided groups, respectively). Graft failures of all grafts were similar in both groups (16% vs. 12%; p = 0.97). Rates of death, myocardial infarction, and stroke were also similar in the study groups, and no difference was seen in revascularization before angiographic follow-up. After 6 months, deferred lesions (n = 24) showed a significant reduction in mean FFR from index to follow-up (0.89 ± 0.05 vs. 0.81 ± 0.11; p = 0.002). Index FFR did not influence graft patency. CONCLUSIONS: FFR-guided CABG had similar graft failure rates and clinical outcomes as angiography-guided CABG. However, FFR was reduced significantly after 6 months in deferred lesions. (Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization [FARGO]; NCT02477371).

Coronary stent implantation and adverse cardiac events after surgery.

BACKGROUND: In the risk assessment of patients considered for non-cardiac surgery and with recent coronary stent implantation, coronary drug-eluting stent implantation procedure characteristics may be taken into account. We aimed to evaluate associations between coronary drug-eluting stent implantation procedure characteristics and the risk of myocardial infarction and all-cause death within 30 days after non-cardiac surgery. DESIGN: Patients with coronary drug-eluting stents were identified using the Western Denmark Heart Registry. Surgical procedures performed after stent implantation were detected using the Danish National Patient Registry. We used registry-based detection of myocardial infarction and all-cause death. RESULTS: Of 22 590 patients treated with drug-eluting stents between 2005 and 2012, 4046 underwent non-cardiac surgery within 1 and 12 months after stent implantation. We found no significant association between the risk of myocardial infarction or all-cause death within 30 days after surgery and number of arteries treated (1 [reference] vs more), number of lesions treated (1 [reference] vs more), segments treated (left main and proximal left anterior descending artery vs other [reference]), total stent length (<20 mm [reference] vs ≥20 mm), number of stents (1 [reference] vs >1) and largest balloon diameter (≥3 mm [reference] vs <3 mm). All-cause death, but not myocardial infarction, risk was lower among patients treated with first-generation vs second-generation stents (odds ratio 0.58). CONCLUSIONS: We identified no significant associations between stent implantation procedure characteristics and risk of myocardial infarction or all-cause death among patients undergoing non-cardiac surgery. All-cause death was lower with first- vs second-generation drug-eluting stents.

Single-centre experience with the Impella CP, 5.0 and RP in 109 consecutive patients with profound cardiogenic shock.

RATIONALE: Short-term mechanical circulatory support is increasingly used in the management of cardiogenic shock, but data from controlled studies are sparse. Thus, real-life data on complication rates and predictors of adverse outcome are important. OBJECTIVE: The objective of this study was to analyse the experience with Impella devices in the management of profound cardiogenic shock. METHODS AND RESULTS: A retrospective study of 109 consecutive patients with severe shock after myocardial infarction, acute heart failure, or cardiac surgery. Possible device-related complications were registered and predictors of death while on Impella support and within 180 days were identified. In 79 patients (72%) cardiogenic shock was caused by myocardial infarction, acute heart failure in 16 (15%) and post-cardiotomy shock in 14 patients (13%). Thirty-five patients (32%) were comatose after cardiac arrest and in seven, the Impella was placed during chest compression. Mean age was 62±12 years, mean arterial pressure was 57±13 mmHg, pH 7.19±0.17 and lactate 7.5±5.7 mmol/l (range 1.8-30.0 mmol/l) at placement. During Impella therapy, 26 patients (28%) died among patients with myocardial infarction or acute heart failure. Of data available prior to placement lactate (hazard ratio 1.14, 95% confidence interval 1.04-1.25, P=0.004) was the only predictor of death on support. During support, five patients (5%) developed leg ischaemia requiring intervention. Bleeding from the Impella insertion site was seen in 14 patients (13%). CONCLUSION: Impella treatment is feasible in profound cardiogenic shock at an acceptable rate of complications. Despite an aggressive approach to restore cardiac output, mortality was high. Besides the severity of lactic acidosis there were no strong predictors of early death.

Quality assurance of the Western Denmark Heart Registry, a population-based healthcare register.

INTRODUCTION: During the past decade, the mandatory population-based healthcare database, the Western Denmark Heart Registry (WDHR), has provided the data for several research projects. As in most clinical registries, the data quality has not been validated thoroughly. This study was undertaken to evaluate the quality of registrations in the WDHR. METHODS: The audit supervised procedures from involved departments that were performed in 2013. An experienced research nurse completed data collection, and an experienced consultant evaluated the agreement between the WDHR and patient records. Indistinct data from patient records were determined after consulting a specialist from the department in question. Patient files were double-checked in case of disagreements between the involved systems. RESULTS: The total proportion of errors in the referral date was 16.4% in surgery, 9.8% in percutaneous invasive procedures (PCI), 16.1% in coronary angiography (CAG) and 19.5% in computed tomography (CT)-CAG, while the errors in inhospital dates were slightly lower. In the cardiac surgery registries, the proportion of errors was 3.3% in the history and EuroSCORE module, 1.0% in the procedure module and 2.8% in the discharge module. For PCI procedures, the errors were 3.8% in the history module, 2.2% in the procedure module and 1.6% in the discharge module. CAG and CT-CAG had slightly more errors. CONCLUSIONS: The quality control of the WDHR revealed that overall data errors were lower than 3% and for procedure-specific registrations including indications and complications, the error rate was below 1.5%. The WDHR is valid and may be used in contemporary epidemiological studies. FUNDING: none. TRIAL REGISTRATION: not relevant.

Gastroscopy-related adverse cardiac events and bleeding complications among patients treated with coronary stents and dual antiplatelet therapy.

BACKGROUND AND STUDY AIMS: Dual antiplatelet therapy (DAPT) is recommended following percutaneous coronary intervention (PCI) with drug-eluting stent (DES). DAPT is a risk factor for gastrointestinal bleeding. We aimed to quantify (1) the rate of gastroscopy within 12 months after PCI, (2) the rate of adverse cardiac events and gastroscopy-related bleeding complications within 30 days of gastroscopy, and (3) the association between antiplatelet therapy and these events. PATIENTS AND METHODS: Patients receiving gastroscopy within 12 months of PCI were identified and two nested case-control analyses were performed within the PCI cohort by linking Danish medical registries. Cases were patients with adverse cardiac events (cardiac death, myocardial infarction, or stent thrombosis) or hemostatic intervention. In both studies, controls were patients with gastroscopy including biopsy without adverse cardiac events and hemostatic intervention, respectively. Medical records were reviewed to obtain information on exposure to DAPT. RESULTS: We identified 22 654 PCI patients of whom 1497 patients (6.6 %) underwent gastroscopy. Twenty-two patients (1.5 %) suffered an adverse cardiac event, 93 patients (6.2 %) received hemostatic intervention during or within 30 days of the index gastroscopy. Interrupting DAPT was associated with a 3.46 times higher risk of adverse cardiac events (95 %CI 0.49 - 24.7). Discontinuation of one antiplatelet agent did not increase the risk (OR 0.65, 95 %CI 0.17 - 2.47). No hemostatic interventions were caused by endoscopic complications. CONCLUSION: Gastroscopy can be safely performed in PCI patients treated with DES and single antiplatelet therapy while interruption of DAPT may be associated with an increased risk of adverse cardiac events.

Dual anti-platelet therapy after coronary drug-eluting stent implantation and surgery-associated major adverse events.

Surgery may necessitate interruption of dual antiplatelet therapy (DAPT) within the first year after coronary drug-eluting stent (DES) implantation. We conducted a population-based cohort study to assess the rate of surgery within the first year after DES implantation, surgery-associated major adverse cardiac events (MACE), reoperation for bleeding within 30 days after surgery, and two nested case-control analyses to explore any association between preoperative antiplatelet therapy, MACE, and reoperation for bleeding. In the cohort of 22,654 patients treated with DES, 1,944 patients (8.6 %) underwent moderate- to high-risk surgery within 12 months. Of these, 62 (3.2 %) experienced MACE and 54 (2.8 %) needed reoperation for bleeding within 30 days. In the nested case-control analyses of 458 cases and controls, where 70 % (n=324) had a first generation DES, absence of preoperative antiplatelet therapy was associated with an increased MACE rate (OR 2.36, 95 % CI 1.02-5.48) compared to single antiplatelet therapy (SAPT) or DAPT. Preoperative SAPT versus DAPT showed no difference in MACE rates (OR 0.85, 95 % CI 0.30-2.40). Surgery within the first month was associated with increased MACE rate (OR 4.67, 95 % CI 2.22-9.83) compared to surgery 2-12 months after DES implantation. Absence of preoperative antiplatelet therapy did not reduce reoperation for bleeding as compared to patients on SAPT or DAPT (OR 1.32, 95 % CI 0.56-3.12). In conclusion, absence of preoperative antiplatelet therapy and surgery within the first month after DES implantation were associated with increased MACE rates.