Incidence and Predictors of Clinically Significant Bleedings after Transcatheter Left Atrial Appendage Closure.

BACKGROUND: Transcatheter left atrial appendage closure (LAAC) is performed in patients unsuitable for long-term anticoagulation, predominantly due to prior bleeding events. The study aimed to investigate the incidence and predictors of clinically significant bleeding (CSB) post-LAAC. METHODS: Consecutive patients after LAAC with an Amplatzer or WATCHMAN device were analyzed (05.2014-11.2019). Bleeding was classified as CSB when associated with at least one of the following: death, ≥2 g/dL hemoglobin drop, ≥2 blood units transfusion, critical anatomic site, or hospitalization/invasive procedure. RESULTS: Among 195 patients (age 74 (68-80), 43.1% females, HAS-BLED score 2.0 (2.0-3.0)), during median follow-up of 370 (IQR, 358-392) days, there were 15 nonprocedural CSBs in 14 (7.2%) patients. Of those, 9 (60.0%) occurred during postprocedural dual antiplatelet therapy (DAPT) (median 46 (IQR: 16-60) days post-LAAC) vs. 6 (40%) after DAPT discontinuation (median 124 (81-210) days post-LAAC), translating into annualized CSB rates of 14.0% (per patient-year on DAPT) vs. 4.6% (per patient-year without DAPT). In 92.9% (13/14) of patients, the post-LAAC nonprocedural CSB was a recurrence from the same site as bleeding pre-LAAC. In the multivariable model, admission systolic blood pressure (SBP) > 127 mmHg (HR = 10.73, 1.37-84.26, p = 0.024), epistaxis history (HR = 5.84, 1.32-25.89, p = 0.020), permanent atrial fibrillation (AF) (HR = 4.55, 1.20-17.20, p = 0.025), and prior gastrointestinal bleeding (HR = 3.35, 1.01-11.08, p = 0.048) predicted post-LAAC CSB. CONCLUSIONS: Nonprocedural CSBs after LAAC, with a similar origin as the pre-LAAC bleedings, were observed predominantly during postprocedural DAPT and predicted by elevated admission SBP, prior epistaxis, permanent AF, and gastrointestinal bleeding history. Whether a more reserved post-LAAC antiplatelet regimen and stringent blood pressure control may improve LAAC outcomes remains to be studied.

Residual stroke risk after left atrial appendage closure in patients with prior oral anticoagulation failure.

BACKGROUND: Patients with atrial fibrillation (AF) and oral anticoagulation (OAC) failure may benefit from left atrial appendage closure (LAAC), however, the evidence is scarce. We report outcomes of LAAC in patients with OAC failure compared to those with classic indications of OAC contraindications. METHODS: Prospective registry of LAAC with Amplatzer or WATCHMAN device followed by dual antiplatelet therapy (DAPT) was analyzed (05.2014-11.2019). The study group included patients with OAC failure defined as stroke/TIA/PE/LAA thrombus (n = 39) during OAC, whereas the control group consisted of patients with OAC contraindications (n = 156). Structured follow-up at 3, 6, and 12 months was done. RESULTS: The study group compared to controls was younger [73 (IQR, 62-77) vs 74 (IQR, 68-81) years, P = 0.046], with higher CHA2DS2-VASc [5.0 (IQR, 3.0-6.0) vs 4.0 (IQR, 3.0-5.0), P = 0.001)], lower HAS-BLED [2.0 (IQR, 1.0-3.0) vs 3.0 (IQR, 2.0-3.0), P = 0.006] and similar proportion of WATCHMAN implantations (43.6% vs 44.2%, P = 1.000). The reduction from CHA2DS2-VASc predicted to observed annual stroke/TIA/PE rate was markedly smaller in the study vs control group (14% vs 77%) with 10.3% vs 1.9% stroke/TIA/PE respectively (P = 0.031). The reduction from HAS-BLED predicted to observed annual major nonprocedural bleeding rate was higher (100% vs 7.4%) with 0.0% vs 5.1% major bleedings respectively (P = 0.361). The device-related thrombosis remained similar (13.2% vs 11.3%, P = 0.778). CONCLUSIONS: Patients after LAAC for OAC failure and unremarkable prior bleeding history presented with high residual stroke and low bleeding risks. Therefore concomitant long-term OAC or prolonged DAPT should strongly be considered in this population.

Higher admission glycaemia independently of diagnosed or unrecognised diabetes mellitus is a risk factor for failed myocardial tissue reperfusion and higher mortality after primary angioplasty.

BACKGROUND AND AIM: Admission hyperglycaemia worsens reperfusion in ST-segment elevation myocardial infarction (STEMI). ST-segment elevation resolution parallels myocardial tissue reperfusion and predicts the outcome of primary percutaneous coronary intervention (pPCI). METHODS: We investigated whether higher glycaemia on admission impairs tissue-level reperfusion after pPCI for STEMI, as-sessed with the single-lead Schröder method of ST-segment resolution analysis (maxSTE). RESULTS: Among 323 patients (60.4 ± 11.5 years, 27.8% female), 13.4% of nondiabetic subjects and 58.2% of those with known diabetic history (17%) were admitted with glycaemia > 11.1 mmol/L. Failed tissue reperfusion, recognised if high-risk maxSTE criteria were fulfilled, was present among 25% of patients. The overall 180-day mortality rate was 6.8% (n = 22). Admission glycaemia ≥ 8.75 mmol/L appeared as the single risk factor for failed tissue reperfusion (ROC area = 0.638, standard error = 0.038, p < 0.001). Even after adjustment for diabetes history, patients with admission glycaemia ≥ 8.75 mmol/L (44.5%) had 2.36-fold higher risk (95% confidence interval [CI] 1.25-4.46, p = 0.008) of failed tissue reperfusion. After exclusion of patients with known diabetes and those with acute blood glucose level > 11.1 mmol/L (28%), admission glycaemia remained an independent predictor of failed tissue reperfusion (odds ratio [OR] 1.32, 95% CI 1.03-1.69, p = 0.028). Admission glycae-mia and failed tissue reperfusion (high- vs. low-risk maxSTE category) were the independent predictors of 180-day mortality (OR 1.18, 95% CI 1.05-1.32, p = 0.004 and OR 3.84, 95% CI 1.12-13.21, p = 0.033, respectively). CONCLUSIONS: Higher admission glycaemia in patients treated with pPCI for STEMI predicts failed myocardial tissue reperfusion and 180-day mortality, independently of prior or acute diabetic status.

Risk is not flat. Comprehensive approach to multidimensional risk management in ST-elevation myocardial infarction treated with primary angioplasty (ANIN STEMI Registry).

INTRODUCTION: Current risk assessment concepts in ST-elevation myocardial infarction (STEMI) are suboptimal for guiding clinical management. AIM: To elaborate a composite risk management concept for STEMI, enhancing clinical decision making. MATERIAL AND METHODS: 1995 unselected, registry patients with STEMI treated with primary percutaneous coronary intervention (pPCI) (mean age 60.1 years, 72.1% men) were included in the study. The independent risk markers were grouped by means of factor analysis, and the appropriate hazards were identified. RESULTS: In-hospital death was the primary outcome, observed in 95 (4.7%) patients. Independent predictors of mortality included age, leukocytosis, hyperglycemia, tachycardia, low blood pressure, impaired renal function, Killip > 1, anemia, and history of coronary disease. The factor analysis identified two significant clusters of risk markers: 1. age-anemia- impaired renal function, interpreted as the patient-related hazard; and 2. tachycardia-Killip > 1-hyperglycemia-leukocytosis, interpreted as the event-related (hemodynamic) hazard. The hazard levels (from low to high) were defined based on the number of respective risk markers. Patient-related hazard determined outcomes most significantly within the low hemodynamic hazard group. CONCLUSIONS: The dissection of the global risk into the combination of patient- and event-related (hemodynamic) hazards allows comprehensive assessment and management of several, often contradictory sources of risk in STEMI. The cohort of high-risk STEMI patients despite hemodynamically trivial infarction face the most suboptimal outcomes under the current invasive management strategy.

Cytochrome P450 2C19 polymorphism, suboptimal reperfusion and all-cause mortality in patients with acute myocardial infarction.

OBJECTIVES: To determine whether the 681 G>A (*2) polymorphism of cytochrome P450 (CYP2C19) is related to suboptimal reperfusion and mortality in patients with acute myocardial infarction (AMI) pretreated with clopidogrel. METHODS: The study included 276 consecutive patients with AMI in whom percutaneous coronary intervention (PCI) with stenting was attempted. Four-year follow-up for all-cause mortality was obtained. RESULTS: There were 15 failed procedures (5.4%). In the remaining 261 patients, suboptimal reperfusion (post-PCI TIMI flow <3) was observed in 12.6% of the cases. There were 56 carriers (50 heterozygous and 6 homozygous) of CYP2C19*2. The prevalence of carriers in patients with suboptimal flow was 39.4% in comparison to 18.9% in the other patients (p = 0.01). Independent predictors of suboptimal reperfusion were initial TIMI flow ≤1 (OR = 5.9, 95% CI 2.2-16.2, p = 0.001) and CYP2C19*2 (OR = 2.9, 95% CI 1.3-6.6, p = 0.01). Thirty patients died during follow-up (11.5%). Four-year mortality tended to be higher in carriers of CYP2C19*2 (17.9%) versus non-carriers (9.8%; p = 0.09), but the only independent predictors of death were age (HR = 2.0, 95% CI = 1.4-2.8, p = 0.0001) and suboptimal reperfusion (HR = 3.6, 95% CI 1.5-8.8, p = 0.004). CONCLUSIONS: The CYP2C19*2 allele is an independent predictor of suboptimal reperfusion in patients with AMI undergoing PCI with stenting after pretreatment with clopidogrel and may increase the risk of all-cause mortality.

Clustering of admission hyperglycemia, impaired renal function and anemia and its impact on in-hospital outcomes in patients with ST-elevation myocardial infarction.

OBJECTIVE: To examine the incidence and inter-relationships between admission hyperglycemia, anemia and impaired renal function and its impact on clinical outcomes in patients with ST-elevation myocardial infarction (STEMI) treated with primary PCI. METHODS: The study group comprised 1880 patients with STEMI treated with primary PCI, enrolled in a prospective registry. RESULTS: The primary endpoint of in-hospital death occurred in 88 (4.7%) patients. Hyperglycemia (glucose >11.1mmol/L) was present in 352(18.7%), anemia (hematocrit <36% women, <39% men) in 396(21.1%), and increased serum creatinine (> or =1.2mg/dL women, > or =1.3mg/dL men) in 423(22.5%) patients. 1026(54.6%) subjects had none of the triad risk factors. Two overlapping conditions were observed in 207(11%) and 3 in 40(2.1%) patients. Compared to the expected distribution, an increased prevalence was observed in patients with zero, two or three risk factors, and decreased prevalence was present in patients with one risk factor (p<0.001). In multivariable model including important baseline risk factors and the whole triad risk factors, hyperglycemia, anemia, and increased serum creatinine were independently associated with the primary outcome (hazard ratio (HR); 95% confidence interval (CI): 2.67; 1.56-4.55, and 2.03; 1.19-3.46, and 1.72;1.01-2.93, respectively). Adjusted HR (95% CI) for the incidence of the primary outcome associated with 1, 2 and 3 examined risk factors as compared to 0 of the risk factors was 2.7(1.4-5.4), 5.4(2.6-8.3) and 8.3(3.0-23.2), respectively. CONCLUSIONS: Hyperglycemia, anemia, and impaired renal function are independently of each other related to in-hospital death in patients with STEMI treated with primary PCI. The triad risk factors cluster and accumulation of these risk factors is related to stepwise, additive increase of risk of in-hospital mortality.

Sodium level on admission and in-hospital outcomes of STEMI patients treated with primary angioplasty: the ANIN Myocardial Infarction Registry.

BACKGROUND: Hyponatremia is a common electrolyte disorder reported to be a predictor of poor prognosis among hospitalized patients, but individuals with high levels also tend to have less favorable outcomes. This study investigated whether sodium level on admission is predictive of in-hospital outcome in patients with ST-elevation myocardial infarction (STEMI) treated with primary angioplasty. MATERIAL/METHODS: Included were 1858 patients admitted with STEMI for primary angioplasty. Sodium level was measured on admission and analyzed as hypo- versus normonatremia and by grouping patients into sodium quintiles. The relationships between sodium level and in-hospital mortality as well as the composite of death or heart failure were assessed. RESULTS: Ninety-six patients had hyponatremia on admission. The hypo- and normonatremic groups were comparable with respect to baseline characteristics and in-hospital management. Hyponatremics had higher rates of in-hospital mortality (13.5% vs. 3.8%, p<0.001) composite of death and heart failure (27.8% vs. 18.4%, p=0.022). After adjustment for covariates, hyponatremia independently correlated with in-hospital mortality (HR: 3.89, 95%CI: 1.59-9.56, p=0.003) and the combined endpoint (HR: 1.73, 95%CI: 1.01-2.99, p=0.047). Patients in the lowest and highest sodium quintiles were 3.27 (95%CI: 1.34-8.02, p=0.009) and 2.65 (95%CI: 1.07-6.60, p=0.036) times more likely to die during hospitalization than those in the 2nd quintile (best survival). In the adjusted model, only patients in the lowest quintile had significantly increased risk of in-hospital death (HR: 6.35, 95%CI: 1.83-21.72, p=0.004). CONCLUSIONS: Hyponatremia is a simple laboratory marker independently associated with increased risk of death in STEMI patients treated with primary angioplasty.

Hemoglobin, leukocytosis and clinical outcomes of ST-elevation myocardial infarction treated with primary angioplasty: ANIN Myocardial Infarction Registry.

BACKGROUND: Hemoglobin (Hb) levels may interact with inflammatory activation, but it is unknown whether the interaction has any impact on clinical outcomes in acute coronary syndromes. The aim of this study was to assess the relationship between admission Hb levels, leukocytosis and clinical outcomes of ST-elevation myocardial infarction (STEMI) treated with primary angioplasty. Methods and Results The study group comprised 1,904 (1,380 men) patients with STEMI treated with primary percutaneous coronary intervention, enrolled in a prospective registry. The primary endpoint of in-hospital death occurred in 90 (4.7%) patients. According to univariate analysis, extreme values of Hb (for 1(st) and 5(th) vs mid quintiles respectively: hazard ratio (HR) =7.1, P<0.001 and HR =3.2, P=0.024) and leukocytosis above median (HR =2.09, P=0.001) significantly correlated with in-hospital death. After dividing patients into high and low white blood cell (WBC) count groups, a U-shaped relationship of Hb levels and mortality was observed for patients with higher leukocytosis (1(st) and 5(th) vs mid quintiles respectively: HR =8.1, P=0.001 and HR =4.4, P=0.022), whereas in patients with lower WBC count higher mortality was related solely to the lowest Hb quintile (HR =6.9, P=0.010 vs mid quintile). Conclusion Higher mortality associated with higher Hb levels in STEMI patients treated with primary angioplasty is limited to patients with increased leukocytosis.

Primary angioplasty in patients > or = 75 years old with ST-elevation myocardial infarction - one-year follow-up results.

BACKGROUND: Efficacy and safety of primary percutaneous coronary angioplasty (PCI) in elderly patients with acute ST-elevation myocardial infarction (STEMI) have not yet been definitely established because these patients were usually excluded from large randomised trials. AIM: To evaluate in-hospital and one-year outcome after primary PCI in elderly patients, and to assess clinical characteristics of this group. METHODS: The study population included 1061 consecutive STEMI patients, mean age 60.6+/-17 years, treated with primary PCI. Clinical characteristics and results of 127 patients aged > or = 75 years were compared to the younger group. RESULTS: Elderly patients were more frequently female (48.4 vs. 23.6%, p <0.005) and diabetics (22.2 vs. 12.1%, p <0.02) and more frequently had renal and/or left ventricular failure (22.3 vs. 9.1%, and 9.1 vs. 4.5%, p <0.005, respectively). In older patients less frequently stents were implanted and TIMI flow 3 was restored (65.1 vs. 78.8%, p <0.05 and 74.6 vs. 84.7%, p <0.03). In-hospital mortality in older versus younger patients was 11.8 vs. 3.0%, p <0.005. The incidence of in-hospital complications (stroke, major bleeding and reinfarction) was similar in both groups. The one-year mortality and MACE rates were higher in older patients (21.3 vs. 6.0% and 24.9 vs. 11.0%, p <0.0005). In multivariate analysis Killip class II-IV (OR 6.73; 95% CI 1.75-25.97, p=0.006) and heart rate (OR 1.04; 95% CI 1.01-1.07, p=0.03) were independent predictors of one-year mortality in patients aged > or = 75 years. CONCLUSIONS: Primary PCI in older STEMI patients is associated with a favourable in-hospital and one-year outcome, although inferior to that seen in younger patients. The in-hospital complication rate is similar in the elderly and in younger patients.

Association of non-specific inflammatory activation with early mortality in patients with ST-elevation acute coronary syndrome treated with primary angioplasty.

BACKGROUND: The association of inflammatory markers with mortality in ST-elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI) remains controversial, so in the present study the relationships of high-sensitivity C-reactive protein (hs-CRP), total white blood cell (WBC) count, neutrophil (N) and lymphocyte (L) counts and the N/L ratio with occurrence of in-hospital mortality were assessed in patients with STEMI treated with primary PCI. METHODS AND RESULTS: Inflammatory parameters were assessed on admission in 1,078 consecutive, unselected patients with STEMI admitted for primary PCI. In-hospital death occurred in 6.3% of the patients. Of the inflammatory parameters, only hs-CRP (p<0.001), and the WBC (p=0.004) and N (p=0.020) counts were predictors of death in the univariate analyses. After adjustment for other baseline clinical variables both hs-CRP and WBC count retained their independent association with mortality when analyzed both in 2 separate and in 1 multivariable models. CONCLUSIONS: Both hs-CRP and the WBC count may independently of each other predict early outcomes in STEMI patients treated with primary PCI, which suggests different pathological significance of these 2 non-specific inflammatory markers in STEMI.

Influenza vaccination in secondary prevention from coronary ischaemic events in coronary artery disease: FLUCAD study.

AIMS: To evaluate the effect of influenza vaccination on the coronary events in patients with confirmed coronary artery disease (CAD). METHODS AND RESULTS: Randomized, double-blind, placebo controlled study. We included 658 optimally treated CAD patients; 477 men, mean age 59.9+/-10.3 years. Three hundred and twenty-five patients received the influenza vaccine, and 333 patients placebo. Median follow-up was 298 (interquartile range 263-317) days. Primary endpoint was the cardiovascular death. Its estimated 12-month cumulative event rate was 0.63% in the vaccine vs. 0.76% in controls (HR 1.06 95% CI: 0.15-7.56, P = 0.95). There were two secondary composite endpoints: (i) the MACE (cardiovascular death, myocardial infarction, coronary revascularization) tended to occur less frequently in the vaccine group vs. placebo with the event rate 3.00 and 5.87%, respectively (HR 0.54;95% CI: 0.24-1.21, P = 0.13). (ii) Coronary ischaemic event (MACE or hospitalization for myocardial ischaemia) estimated 12-month event rate was significantly lower in the vaccine group 6.02 vs. 9.97% in controls (HR 0.54; 95% CI: 0.29-0.99, P = 0.047). CONCLUSION: In optimally treated CAD patients influenza vaccination improves the clinical course of CAD and reduces the frequency of coronary ischaemic events. Large-scale studies are warranted to evaluate the effect of influenza vaccination on cardiovascular mortality. (ClinicalTrials.gov: NCT 00371098).

Comparison of different methods of ST segment resolution analysis for prediction of 1-year mortality after primary angioplasty for acute myocardial infarction.

BACKGROUND: Resolution of ST segment elevation corresponds with myocardial tissue reperfusion and correlates with clinical outcome after ST elevation myocardial infarction. Simpler method evaluating the extent of maximal deviation persisting in a single ECG lead was an even stronger mortality predictor. Our aim was to evaluate and compare prognostic accuracy of different methods of ST segment elevation resolution analysis after primary percutaneous coronary intervention (PCI) in a real-life setting. METHODS: Paired 12-lead ECGs were analyzed in 324 consecutive and unselected patients treated routinely with primary PCI in a single high-volume center. ST segment resolution was quantified and categorized into complete, partial, or none, upon the (1) sum of multilead ST elevations (sumSTE) and (2) sum of ST elevations plus reciprocal depressions (sumSTE+D); or into the low-, medium-, and high-risk groups by (3) the single-lead extent of maximal postprocedural ST deviation (maxSTE). RESULTS: Complete, partial, and nonresolution groups by sumSTE constituted 39%, 40%, and 21% of patients, respective groups by sumSTE+D comprised 40%, 39%, and 21%. The low-, medium-, and high-risk groups constituted 43%, 32%, and 25%. One-year mortality rates for rising risk groups by sumSTE were 4.7%, 10.2%, and 14.5% (P = 0.049), for sumSTE+D 3.8%, 9.6%, and 17.6% (P = 0.004) and for maxSTE 5.1%, 6.7%, and 18.5% (P = 0.001), respectively. After adjustment for multiple covariates only maxSTE (high vs low-risk, odds ratio [OR] 3.10; 95% confidence interval [CI] 1.11-8.63; P = 0.030) and age (OR 1.07; 95% CI 1.02-1.11; P = 0.002) remained independent predictors of mortality. CONCLUSIONS: In unselected population risk stratifications based on the postprocedural ST resolution analysis correlate with 1-year mortality after primary PCI. However, only the single-lead ST deviation analysis allows an independent mortality prediction.

Comparison of prognostic value of epicardial blood flow and early ST-segment resolution after primary coronary angioplasty. ANIN--Myocardial Infarction Registry.

BACKGROUND: TIMI scale is commonly used for angiographic assessment of reperfusion effectiveness and early risk stratification in patients treated with primary angioplasty for ST-elevation myocardial infarction (STEMI). Since ST-resolution analysis allows a noninvasive insight into the reperfusion status at the myocardial tissue level, it may be a better predictor of outcome after primary angioplasty. AIM: To compare the prognostic value of the reperfusion effectiveness evaluation based on either the epicardial blood flow assessment according to the TIMI scale, or ST-segment resolution analysis in patients treated with primary coronary angioplasty for STEMI. METHODS: 324 consecutive patients treated within 12 hours from the pain onset were studied. Based on the analysis of maximal ST-segment elevation/depression identified in a single ECG lead recorded after the procedure (maxSTE), patients were classified into groups of high versus medium/low risk. Independently, distinguished were groups with restored normal (TIMI 3) and abnormal (TIMI 0-2) final blood flow in infarct related artery. RESULTS: The 30-day and one-year mortality rates were higher in the high-risk maxSTE group (25% of all patients) than in the other patients (14.8% vs. 2.5%, p<0.001 and 18.5% vs. 5.4%, p<0.001 respectively). In subjects (82%) with restored TIMI grade 3 blood flow, mortality at one-month and one-year was lower than in the group with abnormal final blood flow (3.1% vs. 15.6%, p=0.001 and 6.2% vs. 18.8%, p=0.005). Comparison in multivariate analysis revealed that maxSTE stratification but not final TIMI grade assessment remained an independent predictor of both, 30-day and one-year mortality (high vs. medium/low-risk category; OR 5.3, 95% CI 1.6-16.7, p=0.005, and OR 3.3, 95% CI 1.4-7.8, p=0.007, respectively). Furthermore, maxSTE proved to stratify the risk of death even in subgroup of patients with restored normal blood flow (OR 6.2, 95% CI 1.4-27.8, p=0.016, and OR 3.0, 95% CI 1.1-8.7, p=0.039, respectively). CONCLUSIONS: Analysis of extent of maximal ST-segment elevation or depression identified in a single ECG lead after primary coronary angioplasty allows better prognosis of subsequent 30-day and one-year mortality than the assessment of final epicardial blood flow, stratifying risk of death even in a subgroup of patients with restored normal blood flow.

White blood cell count adds prognostic information to the thrombolysis in myocardial infarction risk index in patients following primary percutaneous coronary intervention (ANIN Myocardial Infarction Registry).

AIMS: To determine the relationship between baseline white blood cell (WBC) count, Thrombolysis in Myocardial Infarction (TIMI) risk index, and 30-day mortality in unselected patients with ST-elevation myocardial infarction (STEMI) treated with primary mechanical reperfusion (PCI). METHODS AND RESULTS: 903 patients from prospective registry admitted for primary PCI to a tertiary cardiological center. Both baseline WBC count and TIMI risk index data were dichotomized about the respective medians. Overall 30-day mortality was 4.3%. Higher WBC count was associated with adverse clinical outcome (6.3% vs. 2.4%; Kaplan-Meier p=0.004) as were higher TIMI risk index values (7.2% vs. 1.4%; Kaplan-Meier p<0.00001). In addition, median WBC count stratified patients within TIMI risk index strata into very low risk (0%), intermediate risk (3.3%) and high risk (11%) (Kaplan-Meier p=0.023 and p=0.005 for comparison of lower and higher WBC count within TIMI risk index stratas). In multivariate analysis WBC count provided independent and additional to TIMI risk index predictive information (Hosmer-Lemeshow p=0.57 and p=0.88 respectively for predictive value of TIMI risk index alone and combined with WBC count). Other independent predictors of death were current smoking (RR 0.33; 95% CI: 0.13-0.87) and previous MI (RR 3.13; 95% CI: 1.28-7.69). CONCLUSIONS: WBC count may be a simple and useful tool for risk stratification in STEMI patients, providing additional to established risk index prognostic information. Our findings stress the strong correlation of inflammation and poor outcome in STEMI patients, which may indicate directions of development of new therapies.

Serum tissue inhibitor of metalloproteinases-1 and higher risk features of coronary plaque: a volumetric multivessel intravascular ultrasound study.

AIMS: The purpose of this study was to determine the relationship between higher-risk features of coronary plaque and serum levels of matrix metalloproteinase (MMP) family enzymes in the stable angina patients. METHODS AND RESULTS: In 36 patients, 75 coronary lesions were assessed by intravascular ultrasound. For each of the plaques remodelling index, mean calcium arc and plaque burden were measured. Positive remodelling and the values of the calcium arc and plaque burden above the respective medians were regarded as the higher-risk features and summarised for each lesion. Serum levels of MMP-2, -3, -7, -9, and tissue inhibitor of MMP (TIMP)-1 and -2 were measured in all patients. TIMP-1 level was the independent predictor of presence of a lesion with positive remodelling (OR 1.032; 95% CI: 1.004-1.061) and of a lesion with higher plaque burden (OR 1.026; 95% CI: 1.003-1.049) in a given patient. Whereas, MMP-2 level was an independent predictor of presence of a lesion with higher calcium arc (OR 1.035; 95% CI: 1.001-1.071). TIMP-1 level (p=0.003) was also an independent predictor of a number of higher-risk features in the highest-risk plaque in a given patient. CONCLUSIONS: TIMP-1 level correlates with clustering of plaque features associated with higher risk of complications in stable angina patients.

Acute lumen overdilation improves outcome after brachytherapy of in-stent restenosis.

BACKGROUND: The aim of our study was to test the impact of acute lumen overdilation on neointimal hyperplasia and late lumen size after vascular brachytherapy for in-stent restenosis (ISR). METHODS: Forty-seven ISR lesions located in 47 coronary arteries in 44 consecutive patients underwent beta brachytherapy with serial intravascular ultrasound studies. Vessel, lumen, and stent cross-sectional area were measured at 1-mm steps. Based on an interpolated reference cross-sectional area, each cross section was assessed as overdilated (lumen cross-sectional area>interpolated reference cross-sectional area) or not overdilated (lumen cross-sectional area

Determinants of model of renarrowing after beta radiation for in-stent restenosis.

UNLABELLED: It is unknown whether model of renarrowing after beta-radiation for in-stent restenosis (ISR) is influenced by the type of geographic miss (GM). METHODS: In 166 ISR treated with Galileo, serial quantitative coronary angiographic analysis was done. Minimal lumen diameters and lengths were measured for (1) stent, (2) peri-stent subsegments subjected to angioplasty with/without irradiation, and (3) irradiation margins. GM was defined as: (Type 1) edge injury within the 32P source dose fall-off: 2.0 mm inside and outside the source end marker or (Type 2) overt, nonirradiated injury: beyond the outer 2.0-mm long dose fall-off zone. RESULTS: Restenosis rate was 28.3% at 8.9+/-4.5 months with 60% located exclusively outside the stent. Type 1 GM was present in 24.7% of proximal edges, whereas Type 2 in 18.1%. Respective percentages for distal edges were 23.5% and 15.7%. Regardless of presence and type of GM, significant late lumen loss occurred only outside the stent. However, the biggest late lumen loss at the proximal edge was induced by the Type 1 GM (0.65+/-0.79, p<0.001), while proximal Type 2 GM was not associated with edge renarrowing (-0.04+/-0.48, p=NS). Both reference lumen diameter and proximal Type 1 GM influenced restenosis independently (OR 0.47; 95%CI 0.24-0.90; p=0.023 and OR 2.46; 95%CI 1.12-5.40; p=0.025). CONCLUSIONS: Regardless of presence and type of geographic miss, late lumen loss after beta-radiation occurs only outside the stent. However, injury within the proximal 32P dose fall-off but not overt edge injury is associated with the biggest late lumen loss at the respective edge, triggering recurrent restenosis.

Cumulative incidence of coronary lesions with vulnerable characteristics in patients with stable angina pectoris: an intravascular ultrasound and angiographic study.

BACKGROUND: Development of vulnerable lesion may take place simultaneously at many sites of coronary vasculature, therefore causing multisite instability. The prevalence of the phenomenon in stable angina (SA) patients remains unknown. The aim of our study was to assess, in patients with stable angina, the prevalence of coronary plaques with vulnerable characteristics and to ascertain whether the number of such lesions may accumulate. METHODS: Vulnerable plaques are characterised by positive remodelling on intravascular ultrasound (IVUS) and with complex appearance on angiography. We performed preprocedural IVUS in target lesion of 67 patients with SA (46 males, age 55.9). Remodelling index (RI) defined as vessel area at the target lesion divided by that of average reference segments > or = 1.05 was assumed as positive remodelling. Plaques of > or = 30% stenosis on angiography were classified into complex or smooth groups. RESULTS: Positive remodelling was found in 30 (44.8%) and complex plaque in 16 (23.9%) of 67 target lesions. Multiple complex plaques were present in 21 (31.3%) patients. Plaques with positive remodelling more often were complex on angiography (12/30 vs. 4/37, respectively; p=0.005) and were more often associated by complex plaques at other sites (35/30 vs. 23/37; p=0.04) than the remaining lesions. Moreover, the presence of positive remodelling predicted multiple complex lesions at other sites (OR 5.6; 95% CI 1.7-18.3). CONCLUSION: Multiple coronary plaques with vulnerable characteristics are present in nearly one third of patients with stable angina. Incidence of vulnerable lesions may have cumulative character, i.e. the presence of one vulnerable lesion predicts occurrence of further vulnerable plaques.

Acute myocardial infarction complicated by cardiogenic shock. In-hospital and mid-term results of invasive treatment in the National Institute of Cardiology, Warsaw-Anin.

BACKGROUND: Mortality in acute myocardial infarction (MI) complicated by cardiogenic shock approaches 90%, regardless of the type of pharmacological treatment. AIM: To assess in-hospital and mid-term results of invasive treatment of patients with acute MI with ST segment elevation (STEMI) complicated by cardiogenic shock. METHODS: From a prospective registry of all patients admitted to our institution for urgent coronary angiography due to acute coronary syndrome between February 2001 and June 2002, patients with STEMI, symptom duration up to 12 hours and cardiogenic shock diagnosed on admission were identified. The in-hospital and mid-term outcome of 37 patients (mean age 65 years, range 54-77, 68% of males) treated with primary percutaneous coronary intervention (PCI) was analysed. RESULTS: Of the 41 patients with STEMI and cardiogenic shock, total occlusion or critical stenosis of a coronary artery were found in 38 patients. One patient with the occlusion of three main coronary arteries underwent urgent surgical revascularisation and remains alive after an 18-month follow-up. In the remaining 37 patients primary PCI of an infarct-related artery was performed (stent implantation in 70%, abciximab administration in 54%) which restored normal blood flow (TIMI grade 3 flow) in 54% of subjects. In patients with TIMI grade 3 flow the in-hospital mortality was 25%. Of the whole PCI-treated group, 18 (48.6%) patients died during stay in our institution, an additional two - after transfer to another hospital, and one - during a 19-month follow-up period. The remaining 16 patients remain alive (median follow-up of 8 months). CONCLUSIONS: Invasive treatment of patients with STEMI complicated by cardiogenic shock significantly reduces mortality in this high-risk population. The mid-term results in patients discharged from hospital are good. Invasive treatment of acute MI should be accessible for all patients with extensive acute MI.