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Diabetes mellitus (DM) is an important predictor of neointimal hyperplasia (NIH) and adverse clinical outcomes after percutaneous coronary intervention (PCI). LABR-312, a novel intravenous formulation of liposomal alendronate, has been shown in animal models to decrease NIH at vascular injury sites and around stent struts. The aim of the Biorest Liposomal Alendronate Administration for Diabetic Patients Undergoing Drug-Eluting Stent Percutaneous Coronary Intervention trial was to assess the safety, effectiveness, and dose response of LABR-312 administered intravenously at the time of PCI withDES in reducing NIH as measured by optical coherence tomography postprocedure in patients with DM.Patients with DM were randomized to a bolus infusion of LABR-312 vs placebo at the time of PCI. Dose escalation of LABR-312 in the study arm was given: 0.01 mg, 0.03 mg, and 0.08 mg. The primary endpoint was the in-stent %NIH volume at 9 months as measured by optical coherence tomography.From September 2016 to December 2017, 271 patients with DM undergoing PCI were enrolled; 136 patients were randomized to LABR-312 infusion and 135 patients were randomized to placebo. At 9-month follow-up, no difference was seen in the primary endpoint of %NIH between LABR-312 and placebo (13.3% ± 9.2 vs 14.6% ± 8.5, P = .35). No differences were present with the varying LABR-312 doses. Clinical outcomes at 9 months were similar between groups.Among patients with DM undergoing PCI with drug-eluting stents, a bolus of LABR-312 injected systematically at the time of intervention did not result in a lower rate in-stent %NIH volume at 9-month follow-up.

Background: Predicting the severity of coronary artery disease (CAD) may be possible during dobutamine stress echocardiography (DSE) with various indices of left ventricular function. Aims: We assessed the relative value of ejection fraction (EF), force, global longitudinal strain (GLS), and wall motion score index (WMSI) in predicting SYNTAX and Gensini scores in patients with known or suspected CAD. Methods: We prospectively enrolled 223 patients (120 men; mean [SD] age, 62 [9] years) and assessed the following indices: 1) EF (with triplane imaging); 2) force, calculated as the ratio of systolic blood pressure to left ventricular end‑systolic volume; 3) GLS; 4) WMSI. All patients underwent coronary angiography within 12 weeks with SYNTAX and Gensini scores evaluation. Results: The correlation of SYNTAX and Gensini scores was highest with peak WMSI (SYNTAX, rho = 0.591; Gensini, rho = 0.612; P < 0.001), intermediate with peak force (SYNTAX, rho = –0.346; Gensini, rho = –0.377; P < 0.001) and GLS (SYNTAX, rho = –0.205; P = 0.002 and Gensini rho = –0.216; P = 0.001), and the weakest for EF (SYNTAX, rho = –0.149; P = 0.03 and Gensini, rho = –0.191; P = 0.006). The similar hierarchy of variables was detected for changes during DSE. In the subgroup after myocardial infarction (n = 66 [27%]), GLS outperformed the force. Conclusions: In patients with CAD at DSE peak, theWMSI and force were better predictors of the coronary SYNTAX and Gensini scores and CAD severity than GLS or EF. However, in patients after myocardial infarction, the GLS correlation with coronary scores improved and got closer to the visual assessment.

BACKGROUND: Despite primary PCI (PPCI), ST-elevation myocardial infarction (STEMI) can still result in large infarct size (IS). New technology with rapid intravascular cooling showed positive signals for reduction in IS in anterior STEMI. AIMS: We investigated the effectiveness and safety of rapid systemic intravascular hypothermia as an adjunct to PPCI in conscious patients, with anterior STEMI, without cardiac arrest. METHODS: Hypothermia was induced using the ZOLL™ Proteus™️ intravascular cooling system. After randomisation of 111 patients, 58 to hypothermia and 53 to control groups, the study was prematurely discontinued by the sponsor due to inconsistent patient logistics between the groups resulting in significantly longer total ischaemic delay in the hypothermia group (232 vs 188 minutes; p

Aim Three-dimensional (3D) noninvasively acquired datasets containing anatomical information about the heart are a modern option for procedural support during percutaneous cardiac interventions. We present initial experience of patent ductus arteriosus (PDA) closure with workflow integrated with innovative mixed reality display (MRD) to improve 3D perception and navigation in 3D computed tomography angiographic (CTA) datasets. Methods We report incorporation of intraprocedural mixed-reality display of segmented CTA (computed tomography angiography) data using a voice- and gesture controlled head-mounted display during routine percutaneous occlusions of PDA in adults. A dedicated software pathway was used for files conversion, real-time Wi-Fi streaming of 3D rendering from PC to device and manipulation of spatial data during the procedures. Results Pre-recorded CTA studies of aorta and ductus were manually segmented and uploaded into custom designed 3D DICOM for realtime export to MRD device. 3D holograms were successfully displayed during the procedure by commercially available head-mounted display allowing touchless control and image sharing within cath-lab. Wiring of PDA aortic orifice was assisted by 3D hologram controlled by the imaging specialist and shared by the operator. Thus, MRD using evolving versions of custom software was successfully executed with segmented data presented as a semitransparent cubic hologram positioned in a convenient part of visual field allowing real-world action and with touchless control by medical team. Operator appreciated the use of MRD hologram realistically visualizing spatial relationships as practical aid to establish anatomical relationships and facilitate entry into ductus orifice. Procedures were successfully completed using arteriovenous guidewire loop to implant vascular occluders. Conclusions We demonstrate the methodology and software evolution (segmentation, data fusion) allowing practical implementation of intraprocedural mixed reality display of 3D CTA data, with sterile, touchless control of holographic image shared by interventional and imaging team to support percutaneous PDA closure. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): MEDAPP

BACKGROUND: While assessing images using standard segmental method, we felt that some defects were either underscored or missed. So this work is intended to compare results of low count myocardial perfusion studies (MPS) processed with „Myovation Evolution”, applying complete evaluation of all available slices, with full count studies and assess impact of reduction of counts on diagnostic efficacy of the study. MATERIAL AND METHODS: A retrospective study was conducted in a group of 95 patients (56 males, age 62 ± 9 years, BMI 28 ± 4) with known or suspected CAD, without clinical history or any signs of a previous myocardial infarction. All patients underwent coronary angiography (CA) within 3 months of MPS. CA was used as a reference method for diagnostic performance of MPS. Patients underwent a stress/rest 2-day MPS. Both studies were performed twice, with normal (25 s) and shortened (13 s) time/projection. Studies were processed using Myovation protocol (OSEM, 2 iterations, 10 subsets) for full time (FT) studies and a Myovation Evolution protocol for half time (HT) studies (OSEM, 12 iterations, 10 subsets, Resolution Recovery). Reconstructed images, with and without attenuation correction (AC), were evaluated by 2 experienced nuclear medicine specialists (a consensus) visually, taking into account all available slices, in a 5-grade scale (normal, probably normal, equivocal, probably abnormal and abnormal). Study results were additionally dichotomized as normal or abnormal. Perfusion defects were assigned to coronary arteries. RESULTS: An exact agreement between FT and HT study assessment, without AC, amounted to 66%, with AC it grew to 79%, p = 0.05. In studies without AC 10 perfusion defects were found only in HT studies in RCA area in male patients. A higher percentage of studies with perfusion defects in RCA area visible only in HT studies was found among discordant (7/25, 28%) than concordant results (3/70, 4%), p = 0.003. AC reduced this difference. HT study provided lower accuracy in detection of CAD than FT study (58% vs. 68%, p = 0.034). AC reduced this difference considerably. Dichotomized assessment agreed in 81% of studies without AC and in 87% with AC. CONCLUSIONS: Myovation Evolution protocol requires application of AC otherwise perfusion defects in RCA area in male patients are falsely detected. Shortened studies reconstructed with „Myovation Evolution” package without AC reveal a tendency toward reduction of accuracy of the study in detection of CAD. AC makes up for this reduction.

BACKGROUND: The work compares the results of shortened gated myocardial perfusion imaging (MPI), processed with „Myovation Evolution” software, with a study performed in a standard way. MATERIAL AND METHODS : A retrospective study was conducted in a group of 95 patients (56 males and 39 females, age 62 ± 9 years, BMI 28 ± 4) with known or suspected CAD, without clinical history or any signs of a previous myocardial infarction. All patients underwent coronary angiography (CA) within 3 months of MPI. CA was used as a reference for diagnostic performance of MPI. Patients underwent a stress/rest 2-day MPI. Both studies were performed twice, with normal (25s) and shortened (13s) time per projection. Studies were processed using Myovation protocol (OSEM with 2 iterations and 10 subsets) for full time (FT) studies and a Myovation Evolution protocol dedicated to half time (HT) studies (OSEM with 12 iterations, 10 subsets). Reconstructed images, with and without attenuation correction (AC), were evaluated by 2 experienced nuclear medicine specialists (a consensus), with regard to image quality and perfusion, evaluated using a visual semi-quantitative method, applying a standard division of myocardium into 17 segments. Perfusion was assessed in every segment using a standard 5 grade scale. Summed stress scores were calculated for every patient and threshold values for detection of CAD were selected based on ROC analysis with CA treated as a reference method. After 2 months FT images were interpreted again by the same specialists. RESULTS: The quality of images obtained from shortened and normal studies was equally good. All correlation coefficients between segmental scorings of FT and HT studies were high and statistically significant. Correlation coefficients between corresponding segments in FTAC and HTAC (i.e. with AC) studies were systematically higher than without AC. The agreement between FT and HT study results was equal to 81% for FT and HT studies and to 86% for FTAC and HTAC studies (p = 0.40). The repeatability of FTAC study assessments was equal to 94%. 95-percent confidence intervals calculated for agreement between FTAC and HTAC studies and the repeatability of FTAC study overlapped considerably. Correlation coefficients for EDV, ESV and EF values between FT and HT were high: 0.93, 0.96 and 0.88, respectively. CONCLUSION: Myovation Evolution protocol used for reconstruction of myocardial perfusion studies with reduced number of counts requires AC. The agreement between the results of visual assessment of normal and reduced count studies is high and not worse than the agreement between repeat assessment of a full time study.

Introduction The aim of this study was to evaluate the predictive value of selected adipokines in the improvement in the ejection fraction and in the development of adverse cardiac remodeling during 12 months of follow-up among patients with an ST-segment elevation acute myocardial infarction (STEMI) in the presence of metabolic syndrome (MeS). Material and methods The study population consisted of 69 patients (49 male; mean age: 59 ±10 years) with a first STEMI that was treated with a primary percutaneous coronary intervention (pPCI). In this group, 36 patients (18 male; mean age: 60 ±15 years) had MeS according to the definition of the International Diabetes Federation. The baseline clinical evaluation included a clinical examination and evaluation of the blood levels of C-reactive protein, ghrelin, resistin, and fasting glucose. Within 72 h after the STEMI, an echocardiographic examination was performed. A complete clinical evaluation was repeated after 12 months. Adverse cardiac remodeling was defined as an increase in the left ventricular end-diastolic volume of ≥ 8%. An improvement of the ejection fraction (EF) was defined as an increase of more than 5% in the EF. Results A concentration of ghrelin ≤ 160.46 pg/ml (AUC = 0.71, p = 0.032) had a good predictive value for the occurrence of adverse left ventricular remodeling but only in the patients without MeS. Among the patients with MeS, a concentration of resistin ≤ 5196 pg/ml (AUC = 0.073, p = 0.024) had a good predictive value for the occurrence of left ventricular remodeling. A concentration of leptin > 52.18 pg/ml (AUC = 0.81, p < 0.0001) and resistin > 4419.27 ng/ml (AUC = 0.67, p = 0.049) had a good predictive value for improvement of the LVEF in the patients without MeS. Conclusions The selected adipokines had a good predictive value for the development of adverse cardiac remodeling and for improvement of the ejection fraction among patients after a STEMI in the presence of metabolic syndrome.

Zawal serca jest stanem ostrym, ktory moze prowadzic do licznych powiklan we wczesnym okresie pozawalowym. Wystepowanie skrzepliny w lewej komorze u pacjentow po skutecznej pierwotnej przezskornej angioplastyce (PCI) z implantacją stentu i zastosowaniu podwojnej terapii przeciwplytkowej (DAPT) w obecnych czasach jest mniej powszechnym zjawiskiem, zwlaszcza u osob bez ciezkiej pozawalowej dysfunkcji mieśnia lewej komory. Zaprezentowano przypadek 70-letniego mezczyzny, przyjetego do kliniki z prezentacją ostrego zespolu wiencowego leczonego skuteczną pierwotną PCI z implantacją stentu i zastosowaniem DAPT, u ktorego, mimo zastosowanej terapii, w kolejnych badaniach echokardiograficznych podczas hospitalizacji obserwowano skrzepline w koniuszku lewej komory.

Background With emerging new therapeutic concepts including renal denervation (RDN), there is a renewed interest in resistant hypertension (ResH). Among patients suspected of having ResH, a definitive diagnosis needs to be established. Objectives This study presents observations from a standardized single-center screening program for RDN candidates, including medical therapy modification and reassessment. Material and methods All patients referred to our center for RDN underwent a standardized screening protocol. Candidates were recruited from among patients receiving no less than 3 antihypertensive drugs, including diuretics with office blood pressure (BP) >140/90 mm Hg. The assessment included 2 measurements of BP and ambulatory BP monitoring (ABPM). If needed, pharmacotherapy was intensified and the diagnosis of ResH was reconfirmed after 6 weeks. If ResH was persistent, patients were hospitalized with repeated ABPM on day 4. Further, renal CT-angio was performed and a multidisciplinary team discussed the patients' suitability for RDN. Results A total of 87 patients with a ResH diagnosis were referred for RDN. Mean office BP was 159/92 (±7.0/6.5) mm Hg and mean ABPM was 154/90 (±9.0/4.8) mm Hg. The initial medication included angiotensin convertase inhibitors (ACE-I, 78%), angiotensin receptor blockers (12%), β-blockers (85%), calcium channel blockers (36%), and diuretics (93%). During the 18 months of the RDN program, 5 patients underwent RDN and 2 further had ineligible renal anatomy. A new diagnosis of secondary hypertension was made in 21 patients. However, in 59 patients, BP control was achieved after optimization of medical therapy, with a mean ABPM of 124/74 mm Hg. The final treatment included ACE-I (100%), β-blockers (92%), indapamide (94%), amlodipine (72%), and spironolactone (61%). Medication in most of these patients (88%) included single-pill triple combination (52.5%) or double combination (35.6%). Conclusions Patients with elevated BP screened for RDN require a rigorous diagnostic workup. Up to 2/3 of patients can be managed with strict pharmacotherapy compliance and pharmaceutical intensification, including single-pill combinations and improved drug compliance. Hasty use of RDN may be a result of poor drug optimization and/or compliance. It does remain a viable treatment option in thoroughly vetted ResH patients.

Background Three-dimensional (3D) echocardiographic data acquired from transesophageal (TEE) window are commonly used in planning and during percutaneous structural cardiac interventions (PSCI). Purpose We hypothesized that innovative, interactive mixed reality display can be integrated with procedural PSCI workflow to improve perception and interpretation of 3D data representing cardiac anatomy. Methods 3D TEE datasets were acquired before, during and after the completion of PSCI in 8 patients (occluders: 2 atrial appendage, 2 patent foramen ovale and 3 atrial septal implantations and percutaneous mitral commissurotomy). 30 Carthesian DICOM files were used to test the feasibility of mixed reality with commercially available head-mounted device (overlying hologram of 3D TEE data onto real-world view) as display for the interventional or imaging operator. Dedicated software was used for files conversion and 3D rendering of data to display device (in 1 case real-time Wi-Fi streaming from echocardiograph) and spatial manipulation of hologram during PSCI. Custom viewer was used to perform volume rendering and adjustment (cropping, transparency and shading control). Results Pre- and intraprocedural 3D TEE was performed in all 8 patients (5 women, age 40–83). Thirty selected 3DTEE datasets were successfully transferred and displayed in mixed reality head-mounted device as a holographic image overlying the real world view. The analysis was performed both before and during the procedure and compared with flatscreen 2-D display of the echocardiograph. In one case, real-time data transfer was successfully implemented during mitral balloon commissurotomy. The quality of visualization was judged as good without diagnostic content loss in all (100%) datasets. Both target structures and additional anatomical details were clearly presented including fenestrations of atrial septal defect, prominent Eustachian valve and earlier cardiac implants. Volume rendered views were touchlessly manipulated and displayed with a selection of intensity windows, transfer functions, and filters. Detail display was judged comparable to current 2-D volume-rendering on commercial workstations and touchless user interface - comfortable for optimization of views during PSCI. Conclusions Mixed reality display using a commercially available head-mounted device can be successfully integrated with preparation and execution of PSCI. The benefits of this solution include touchless image control and unobstructed real world viewing facilitating intraprocedural use, thus showing superiority over virtual or enhanced reality solutions. Expected progress includes integration of color flow data and optimization of real-time streaming option.

The aim of the study was to check, in clinical practice, the potential for the dose reduction of lead eyewear and a ceiling-suspended shield used to protect the eye lens of physicians working in interventional cardiology. To this end, for the lead eyewear, the dose reduction factors were derived to correct the readings from a dosimeter used routinely outside the glasses. Four types of lead eyewear with attached loose thermoluminescent dosimeters and EYE-D dosimeters were worn by physicians in two clinical centres, for two-month periods, during coronary angiography (CA), percutaneous coronary intervention (PCI), and pacemaker procedures. In order to analyse, separately, how a ceiling-suspended lead screen absorbs the scattered radiation, a series of measurements was carried out during single CA/PCI procedures performed with and without the protection. The lead eyewear may reduce the doses to the eye closest to the x-ray tube by a factor between 1.1 and 3.4, depending on its model and the physician's position. The effectiveness of the eyewear may, however, vary-even for the same model and physician-almost twofold between different working periods. The ceiling-suspended shield decreases the doses in clinical practice by a factor of 2.3. The annual eye lens doses without the eyewear estimated from routine measurements are high-above or close to the new eye lens dose limit established by the recent EU Basic Safety Standards, even though the ceiling-suspended shield was used. Therefore, to comply with the new dose limit that is set in the Directive, protection of the eyes of physicians with high workloads might require the use of both the eyewear and the ceiling-suspended shield.

Patients after previous coronary artery bypass grafting (CABG) often require repeat percutaneous revascularisation due to poor patency rates of saphenous vein grafts (SVG) and higher risk of re-CABG. Few data are available to evaluate different percutaneous revascularisation strategies in patients after previous CABG.To evaluate outcomes of percutaneous coronary intervention (PCI) in patients after previous CABG, including the effect of treatment on the quality of life and symptoms, and secondly to assess the relation between angiographic factors and treatment outcomesThis was a prospective observational study which included 78 patients after previous CABG. Following coronary angiography, the patients were assigned to one of three groups: group A (n = 20), PCI of a SVG (PCI SVG); group B (n = 29), PCI of a native coronary artery (PCI NA); group C (n = 29), control group that received medical treatment (MT) only. Duration of follow-up was 12 months.Compared to MT patients, patients treated with PCI had significantly higher Canadian Cardiovascular Society (CCS) class (2.75 vs. 2.41, p = 0.03) and more frequently had coronary angiography performed due to unstable angina (57% vs. 31%, p = 0.04). Patients in the PCI SVG group had significantly older SVG conduits compared to the PCI NA group (13.4 years vs. 8.2 years, p = 0.005). At 12 months of follow-up, we found a significant improvement in the EQ-5D index of the quality of life, and a significant reduction in CCS class in the PCI SVG group (0.66 vs. 0.7, p = 0.0003, and 2.75 vs. 1.9, p0.001, respectively) and in the PCI NA group (0.65 vs. 0.72, p0.001, and 2.75 vs. 2.17, p0.001, respectively), but no improvement in the MT group. Treatment outcomes did not differ significantly between the three groups (combined endpoint rate 20% vs. 13% vs. 27.5%, p = 0.37). In multivariate analysis, SVG age11 years was identified as a significant predictor of poor outcomes in patients treated with PCI after previous CABG.PCI in patients after previous CABG does not improve prognosis but significantly improves the quality of life and reduces symptom severity.

The association between anatomic features of the left anterior descending artery (LAD) and outcomes in patients with anterior ST-segment elevation myocardial infarction (STEMI) has not been fully investigated. We sought to clarify the impact of an LAD coronary artery wrapping around the left ventricular (LV) apex on clinical outcomes in patients with anterior STEMI. Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction enrolled patients with STEMI presenting12 hours after symptom onset who underwent primary percutaneous coronary intervention. Patients with a culprit lesion in the LAD were categorized as (1) LAD wrapping around the LV apex (wrap-around LAD, n = 871) versus (2) LAD not wrapping around the LV apex (non-wrap-around LAD, n = 224). Killip class ≥II, dysrhythmia, and LV mural thrombi were more frequently observed in the wrap-around LAD group; LV ejection fraction was worse in the wrap-around LAD group (54.5% vs 58.7%, p = 0.006). At 3 years of follow-up, major adverse cardiac events (death, stroke, or stent thrombosis, 12.7% vs 5.4%, p = 0.002), death (6.6% vs 3.2%, p = 0.052), stroke (1.9% vs 0.5%, p = 0.12), stent thrombosis (5.6% vs 2.3%, p = 0.047), and severe heart failure (4.5% vs 1.4%, p = 0.03) were more common in patients with a wrap-around LAD versus those with a non-wrap-around LAD. Multivariate analysis indicated that a wrap-around LAD independently and significantly predicted major adverse cardiac events (hazard ratio 2.18, p = 0.02) and severe heart failure (odds ratio 3.31, p = 0.049) in patients with an anterior STEMI. In conclusion, a wrap-around LAD predicted adverse clinical outcomes at 3 years in patients with anterior STEMI who underwent primary percutaneous coronary intervention.

Aim of the study Ongoing national screening programmes suggest that the prevalence of chronic hepatitis C (CHC) in Poland ranges between 0.5% and 1%. It has been recently noted that patients with confirmed coronary artery disease may be at higher risk for hepatitis C virus (HCV) infection. Material and methods Testing for the presence of anti-HCV antibodies was performed in a group of patients admitted to the Cardiology Department with symptomatic ischemic heart disease (IHD) and in patients hospitalised in the Dermatology Department. Results A total of 1171 patients underwent anti-HCV testing: 672 patients in the Cardiology Department (K group) and 499 patients in the Dermatology Department (D group). Twenty-eight (2.4%) positive anti-HCV results were detected. The prevalence of positive anti-HCV antibodies in groups K and D was 2.23% and 2.61%, respectively (p > 0.05). Presence of HCV RNA was confirmed in 15 cases (1.28%) - 7 patients in group K and 8 patients in group D (1.04% and 1.6%, respectively; p > 0.05). Conclusions Our findings suggest that this patient cohort has increased risk of HCV infection, which may influence screening strategies.

Background The Global Registry of Acute Coronary Events (GRACE) study produced a scale for risk stratification in acute coronary syndromes (ACSs). Pregnancy-associated plasma protein A (PAPP-A) serum concentration was implicated as a marker of unstable atherosclerotic plaques. Objectives We hypothesized that the measurement of the concentration of PAPP-A on admission may improve the stratification of cardiovascular risk in suspected ACS patients. Material and methods We studied 70 patients with chest pain suggesting ACS diagnosis on admission. Serum cardiac biomarkers and PAPP-A were measured on top of the standard biochemical panel, and the GRACE risk score was calculated. A 12-month follow-up was completed to major adverse cardiac events (MACE): death, myocardial infarction (MI), need for percutaneous coronary intervention (PCI)/coronary artery bypass grafting (CABG), unplanned cardiovascular hospitalization. Results In hospital/6-month GRACE, low risk was found in 35 patients (50%)/37 patients (53%), intermediate risk in 23 patients (33%)/21 patients (30%) and high risk in 12 patients (17%)/12 patients (17%). Mean PAPP-A was 39.64 mlU/L (standard deviation - SD 24.2), and median PAPP-A values for in hospital/6-month GRACE were 21.49 mlU/L (quartile 1st; 3rd - 13.41; 32.65) and 22.61 mlU/L (14.03; 34.1) for low risk patients, 51.76 mlU/L (35.18; 59.99) and 51.76 mlU/L (28.9; 62.1) for intermediate risk patients, and 68.82 mlU/L (58.54; 83.76) for high risk patients. The PAAP-A concentration with specific cut-off points had 66.7% positive predictive value (PPV) and 95.5% negative predictive value (NPV) for death, 33.3% PPV and 80.6% NPV for MI, 71.4% PPV and 57.1% NPV for any event. Intermediate and high in hospital/6-months GRACE had 14.3%/15.2% PPV and 100%/100% NPV for death, 34.3%/33.3% PPV and 94.3%/91.9% NPV for MI, 74.3%/72.7% PPV and 65.7%/62.2% NPV for any event. Conclusions The PAPP-A serum concentration represents a promising prognostic biomarker with significantly improved PPV. The GRACE score is superior to stratification based on PAPP-A with regard to combined cut-off point for 1-year mortality.

BACKGROUND: Use of CT based attenuation correction (AC) for myocardial perfusion SPECT (MPS) is growing fast due to a rapid development of hybrid SPECT/CT systems. SPECT and CT studies are performed in a sequential way extending total study acquisition and making a patient movement more likely. The present work aims at answering the question how large misalignment between SPECT and CT studies should be considered significant and how often those misregistrations are observed. MATERIAL AND METHODS: A retrospective study applying AC was performed in 107 patients who had coronary angiography (CA) performed within 3 months. Patients underwent a stress/rest Tc-99m MIBI 2 day SPECT/CT myocardial perfusion study. In case of SPECT and CT misalignment CT slices were shifted manually; shifts along 3 axes were recorded and after realignment a repeat reconstruction was performed. Euclidean distance of misalignment was also calculated. Images were analyzed by two experienced nuclear medicine specialists (consensus) applying visual semiquantitative method. Perfusion of three arteries was scored using a 5 grade scale. CA results were used as a reference for MPS findings. RESULTS: In 47 patients (44%) CT realignment was necessary. CT was shifted mostly along x and y axes, and less often along z axis. Euclidean distance S exceeded 2 pixels in 3 stress and 2 rest studies. Only in 7 patients changes of scores assigned to coronary vessels were noted as a result of CT realignment. These changes concerned 9 vessel areas. In 7 out of 9 cases changes were noted toward a better agreement with results of CA. Only in one patient, with stress S > 3 pixels and negative result of CA, CT realignment changed vessel area score significantly, from probably abnormal to normal. CONCLUSIONS: Only misalignments large enough, exceeding 2–3 pixels, have negative impact on attenuation corrected images. Such misalignments are rare, in our material were observed in 3 stress and 2 rest studies (3% and 2% of all studies, respectively). Only in one patient (below 1% of all studied patients) CT misalignment caused a significant study misinterpretation. Although alignment of SPECT and CT studies should be checked in every patient, small misalignments do not affect study interpretation.

A proven advantage of radial over femoral arterial access has led to an increase in the number of interventions performed via radial artery access in patients with acute coronary syndromes. Both assessment of the pulse volume and the Allen's test are subjective and subject to investigator bias. An ultrasound examination of the forearm arteries provides important information about the anatomy of the forearm vessels, and indirectly also about the efficiency of collateral blood supply to the hand. It also enables determination of the relevant vessel diameter before the planned intervention, and may be used to assess local complications.To assess the morphology of forearm blood vessels and measure the diameter of both radial and ulnar arteries at the cannulation site using ultrasound imaging. We also aimed to identify potential vascular anomalies and local complications associated with radial artery puncture.The study included 109 patients with cardiologic indications for coronary angiography or coronary angioplasty. An ultrasound evaluation of forearm arteries was performed prior to the intervention, and the vascular anatomy was later verified by angiography during the procedure. Ultrasound measurements of the vessel diameter were also performed and local complications of the cannulation were assessed. Measurements were performed immediately after the procedure and at 30 days and 12 months.Fifty-nine right and 50 left forearm arteries were evaluated. Women were 29% of the study population. The mean patient age was 59.2 ± 7.9 years. The mean diameter of the right radial artery was 2.17 ± 0.54 mm, and the mean diameter of the left radial artery was 2.25 ± 0.43 mm. The measurements revealed gender-related differences in forearm artery diameter (p = 0.003). Vascular anomalies of the radial artery were identified by ultrasound examination in 10% of subjects. A significant dilatation of the cannulated blood vessel was observed which lasted up to 12 months. An occlusion of the cannulated artery was demonstrated in 6.4% of patients.Ultrasound imaging is a reliable method to evaluate the diameter of forearm arteries and track their course in patients undergoing invasive cardiovascular procedures via radial artery access. The diameter of the radial artery by ultrasound evaluation is larger compared to that of the ulnar artery. The diameter of forearm arteries in women is smaller compared to men. A dilatation of the radial artery which may last up to 12 months develops following its percutaneous cannulation. Ultrasound imaging allows detection and monitoring of local complications such as radial artery occlusion. An unfavourable ratio of blood vessel diameter to the size of the used introducer sheath is a predictor of radial artery occlusion. Ultrasound imaging enables reliable evaluation of vascular anomalies involving the radial artery, especially within the distal forearm.

Background: General anaesthesia may have negative impact on patient mortality and morbidity, as well as overall procedure costs, in atrial septal occluder (ASO) implantation. Aim: We sought to evaluate the safety, efficacy, and feasibility of conscious sedation for transcatheter implantation of ASOs. Methods: A total of 122 patients referred for transcatheter implantation of ASO were included. Mean patient age was 51 ± 15 years, and 43 (35%) patients were male. The initial dose of midazolam was 2 mg and fentanyl dose was 25 μg. Additional doses of midazolam and fentanyl were administered, if necessary. Patient responsiveness was assessed every 10 min, and the sedatives doses were titrated in order not to exceed grade 3 sedation in the Ramsey scale. Results: Atrial septal occluders were successfully implanted in the majority of patients (98.4%). In two (1.6%) cases the proce­dure failed because of too small patent foramen ovale (PFO) diameter (n = 1, 0.8%) or device instability (n = 1, 0.8%). The mean duration of procedure was 47.6 ± 28.4 min and was similar for ASD and PFO closure (p = 0.522). The overall mean dose of midazolam was 4.7 ± 2.2 mg (63.9 ± 32.5 μg/kg) and fentanyl was 30.0 ± 11.9 μg (0.43 ± 0.17 μg/kg). Median entrance dose of radiation at the patient plane was 25 (interquartile range: 16–57) mGy, and did not differ between ASD and PFO procedures (p = 0.614). The majority of patients were free of complications (91.0%). The following early complications were observed: transient ischaemic attack (n = 2, 1.6%), supraventricular arrhythmias (n = 4, 3.3%), left atrial thrombus formation (n = 1, 0.8%), symptomatic bradycardia (n = 1, 0.8%), and femoral venous bleeding (n = 5, 4.1%). After mean follow-up of 386 days residual shunt was observed in eight (6.6%) patients. Conclusions: Conscious sedation for transcatheter implantation of ASO is a feasible, safe, and efficient technique, allowing successful PFO and ASD closure in the majority of patients.

Aims: We aimed to investigate the rapid induction of therapeutic hypothermia using the ZOLL Proteus Intravascular Temperature Management System in patients with anterior ST-elevation myocardial infarction (STEMI) without cardiac arrest. Methods and results: A total of 50 patients were randomised; 22 patients (88%; 95% confidence interval [CI]: 69-97%) in the hypothermia group and 23 patients (92%; 95% CI: 74-99) in the control group completed cardiac magnetic resonance imaging at four to six days and 30-day follow-up. Intravascular temperature at coronary guidewire crossing after 20.5 minutes of endovascular cooling decreased to 33.6°C (range 31.9-35.5°C). There was a 17-minute (95% CI: 4.6-29.8 min) cooling-related delay to reperfusion. In “per protocol” analysis, median infarct size/left ventricular mass was 16.7% in the hypothermia group versus 23.8% in the control group (absolute reduction 7.1%, relative reduction 30%; p=0.31) and median left ventricular ejection fraction (LVEF) was 42% in the hypothermia group and 40% in the control group (absolute reduction 2.4%, relative reduction 6%; p=0.36). Except for self-terminating paroxysmal atrial fibrillation (32% versus 8%; p=0.074), there was no excess of adverse events in the hypothermia group. Conclusions: We rapidly and safely cooled patients with anterior STEMI to 33.6°C at the time of coronary guidewire crossing. This is ≥1.1°C lower than in previous cooling studies. Except for self-terminating atrial fibrillation, there was no excess of adverse events and no clinically important cooling-related delay to reperfusion. A statistically non-significant numerical 7.1% absolute and 30% relative reduction in infarct size warrants a pivotal trial powered for efficacy. ClinicalTrials.gov Identifier: NCT02509832

Introduction Early initiation of reperfusion therapy including primary percutaneous coronary revascularization (PPCI) has been recognized as a crucial factor determining clinical outcomes in the acute phase of myocardial infarction. In unstable patients with type 2 diabetes mellitus (T2D) the clear benefit from PPCI was proven. We aim to evaluate the prognostic value of factors describing glycometabolic state on admission in patients with T2D undergoing PPCI in acute ST-elevation myocardial infarction (STEMI). Material and methods Prospective analysis of clinical and laboratory variables (mean daily short acting exogenous insulin dose (DID), admission blood glucose, glycated hemoglobin (HbA1c), microalbuminuria) was performed in 112 consecutive patients with T2D with STEMI who underwent PPCI. Women comprised 58% of the group. Results Insulin dosing was targeted to obtain a mean daily glucose level < 7.8 mmol/l. During 12-month follow-up 33 (29.5%) major adverse cardiac events (major adverse cardiac events (MACE) consisting of death, reinfarction, and repeated target vessel revascularization) were reported. Microalbuminuria was present in 68 (60.5%) patients. The mean HbA1c level was 7.9%. In the multivariate logistic regression model only DID > 44 IU remained an independent risk factor for MACE (p = 0.02, OR = 5.2). Conclusions In patients with diabetes with STEMI treated with PPCI, simple measurement of DID during hospitalization can add valuable prognostic information about the future risk of MACE.

Left ventricular (LV) dysfunction during and after hospitalization for ST-segment elevation myocardial infarction (STEMI) is associated with increased mortality. Whether baseline LV dysfunction impacts STEMI outcomes is not well studied. Furthermore, whether bivalirudin and paclitaxel-eluting stents (PES) are beneficial in patients with LV dysfunction is unknown. We studied the impact of left ventricular ejection fraction (LVEF) on outcomes of patients with STEMI in the HORIZONS-AMI trial.LVEF was determined in 2648 (73.5%) of 3602 enrolled STEMI patients, who were divided into three groups according to LV function: (1) severely impaired (LVEF40%); (2) moderately impaired (LVEF 40-50%); and (3) normal (LVEF ≥50%).Compared to patients with normal LV function, those with severely impaired LVEF had higher 1-year rates of net adverse clinical events (27.1 vs. 14.2%, p0.0001), major adverse cardiovascular events (20.7 vs. 9.5%, p0.0001), cardiac death (10.6 vs. 1.2%, p0.0001), and non-coronary artery bypass graft major bleeding (12.5 vs. 6.6%, p=0.001), differences which persisted after adjustment for baseline characteristics. Among patients with LVEF40%, treatment with bivalirudin compared to heparin+GPIIb/IIIa inhibitors resulted in reduced 1-year mortality (5.8 vs. 18.3%, p=0.007). Patients with LVEF40% receiving PES rather than bare metal stents had lower rates of 1-year ischaemia-driven target lesion revascularization (2.9 vs. 12.6%, p=0.02) and reinfarction (4.5 vs. 14.7%, p=0.03).Among patients with STEMI undergoing primary percutaneous coronary intervention, adverse events are markedly increased in those with LVEF40% during the index revascularization procedure. Nevertheless, these high-risk patients experience substantial clinical benefits from bivalirudin and PES.

Isolated critical stenosis of left main coronary artery (LMCA) due to atherosclerosis is very rare and affects about 0.2% of patients. We present the case of a 39-year-old, non-smoker women with risk factors for diseases of the cardiovascular system in the form of hypercholesterolaemia and hypertension, in addition to positive family history and chronic oral contraception. Sick from occurring since atypical angina masked depressive symptoms, with a critical stenosis of LMCA and little suggestive symptoms of ischaemia because of the existing collateral circulation.

The clinical features and prognosis of patients with ST-segment elevation myocardial infarction (STEMI) and no significant coronary artery disease (CAD) have not been well studied. We examined the outcomes of patients with STEMI in the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial according to the presence or absence of significant CAD. "No-CAD" was defined by the absence of any lesion with a diameter stenosis of ≥30% on quantitative coronary angiography of the baseline coronary angiogram. Of 3,602 patients, 127 (3.5%) had no-CAD. Of these, 86 (67.7%) had angiographically normal coronary arteries, and 41 (32.3%) had mild disease (diameter stenosis

We report a case of a 57-year-old man with typical angina due to a coronary artery-to-pulmonary artery fistula, which was evident on transthoracic and transesophageal echocardiography with color Doppler flow mapping. The diagnosis was confirmed by coronary angiography. The patient underwent surgical ligation of the fistula. However, repeated transesophageal echocardiography and coronary angiography revealed persistence of the fistula with significant left-to-right shunt. The orifice of the fistula was then obliterated by stent-graft implantation, which was proven successful by angiography and echocardiography.

Background: Pseudoaneurysms (PAs) and arteriovenous fistulas (AVFs) are among the most serious access-site vascular complications of percutaneous diagnostic and therapeutic procedures in coronary artery disease. Aim: To assess the clinical course and methods of treatment of these access-site complications. Material and methods: Medical records of 26 949 patients who underwent coronary angiography and/or angioplasty in the period 2000-2009 in two tertiary referral level catheterization laboratories were reviewed. We identified 91 patients with confirmed accesssite complications: 90 iatrogenic PAs and 3 AVFs (2 of which were accompanied by PA). Results: Prolonged compression with an elastic bandage was the most frequently (55 patients) used first-line treatment of PAs. Others included compression with ultrasound probe (15 patients), ultrasound-guided thrombin injection (11 patients), and surgery (3 patients). Forty-seven patients with PAs required second-line treatment, which in most cases was thrombin injection (23 patients). Thrombin injection and compression with ultrasound probe were the most frequently used third-line treatment techniques. The overall effectiveness (complete closure of PA) of the treatment techniques was: surgery – 100%, thrombin injection – 86.8%, compression with ultrasound probe – 70.8%, prolonged compression with elastic bandage – 42.4%, observation – 0%. Conclusions: Significant access-site complications of percutaneous coronary interventions, especially AVFs, are infrequent. Spontaneous closure of the PA during hospitalization was not observed. Both thrombin injection and compression with an ultrasound probe allow for fast and effective treatment of iatrogenic PA. However, surgery remains the most effective treatment technique. Prolonged compression with an elastic bandage offers low efficacy.

The prevalence of coronary artery anomalies (CAA) is reported to be 1% in the general population [1]. The symptoms vary from clinically silent course to angina pectoris, syncope, arrhythmias, myocardial infarction and sudden cardiac death. Although coronary angiography remains a gold standard for the evaluation of coronary anatomy, modern echocardiography offers additional diagnostic opportunities, including assessment of proximal coronary anatomy, flow and coronary flow reserve in a variety of clinical conditions [2–6]. However, experience with echocardiography in patients with concomitant coronary anomalies and atherosclerotic diseases is rather limited. We report a case of a 69-year-old man, with angina and ventricular arrhythmia, in whom we successfully applied echocardiographic imaging modalities to demonstrate an abnormal course of the circumflex coronary artery and identify coronary stenosis-related flow abnormalities. A 69-year-old man was admitted to our hospital in February 2007 with chest pain on minor exertion, radiating to left arm and to the back, aggravating over the last month. Similar, less intense pain had been observed for 3 months. Concomitant history included pharmacologically controlled hypertension, type 2 diabetes mellitus with polyneuropathy, hypercholesterolaemia, peripheral artery disease, depression and benign prostatic hypertrophy. Admission ECG was unremarkable except for a few ventricular premature beats. Admission blood pressure was 130/85. Echocardiography revealed a minor systolic dysfunction: hypokinesis of mid- and apical segments of the lateral and posterior wall, with left ventricular ejection fraction of 58%. The left atrium was enlarged to 45 mm and the left ventricular mass index was increased to 141 g/m2. Mitral inflow was pseudonormal with E/A ratio 1.2. There was a mild commissural fusion of the aortic valve cusps, without significant motion impairment, a peak velocity of 1.7 m/s and trace of regurgitation. Serum concentrations of troponin I and CK-MB were within normal limits. Exercise treadmill test (Bruce procedure) elicited no angina but was electrographically positive with ST segment depression in leads V4-6 at 7 METS workload. In 24-h Holter ECG monitoring 6518 ventricular premature beats but neither complex arrhythmia nor significant ST segment changes were recorded. Transthoracic echocardiography (GE, Vivid 7 Dimension; transducer M4S) of coronary arteries showed abnormal findings in the left coronary ostium, with calcifications and accelerated turbulent flow consistent with high-degree stenosis (Figure 1). Diastolic flow was accelerated to 1.3 m/s. Non-invasive Doppler transthoracic coronary flow reserve (CFR) was measured according to the standard technique, in the distal left anterior descending (LAD) coronary artery during 12 mg adenosine injection, yielding an abnormally low value of 1.4. Figure 1 The arrows indicate stenosis of the left coronary ostium, detected in angiography and transthoracic echocardiography. In the panel below – normal distal left anterior descending coronary artery LAD – left anterior descending coronary artery, ... Subsequently, the abnormal coronary artery ostium was visualized in the right sinus of Valsalva, continuous with a vessel running retroaortically, consistent with the anomalous circumflex coronary artery course (Figure 2). Distal circumflex stenosis was not detectable using transthoracic echocardiography (TTE). Figure 2 The arrows show anomalous circumflex coronary artery running retroaortically, in the right panels the flow detected by Doppler echocardiography. Below: angiography of the circumflex coronary artery originating next to the right coronary artery and separate ... Coronary angiography revealed 90% ostial stenosis of the left coronary artery, with the absence of origin of the circumflex branch (CX); the distal LAD coronary artery was normal. The circumflex coronary artery originated next to the right coronary artery, running in an inferior direction, reaching its proper course after 3-4 cm; the CX was narrowed to 90%. The right coronary artery was narrow and tortuous.The patient was referred to cardiac surgery for coronary artery bypass grafting. Our report indicates that state-of-the-art, high-end TTE allows the evaluation of coronary anatomy and coronary flow reserve, facilitating the assessment of anomalous coronary arteries combined with advanced coronary artery disease. Non-invasive data are complementary to standard angiographic findings. Angiography remains a gold standard for the evaluation of coronary anatomy. However, in some cases, echocardiography may suggest an initial diagnosis. State-of-the-art transthoracic examination is nowadays powerful enough to aid in the assessment of coronary anomalies as the ostia and proximal course can usually be visualized [7–9]. Carefully performed investigation may identify coronary disease in clinically silent or unclear cases, especially in proximal arterial segments. Coronary artery anomalies may be clinically silent but often cause symptoms such as angina pectoris, syncope, arrhythmias, myocardial infarction, and sudden cardiac death. Importantly, coronary anomalies constitute the second most common cause of sudden cardiac death in young athletes. Particularly dangerous and potentially lethal variants involve Bland-White-Garland syndrome (anomalous origin of the left coronary artery from the pulmonary artery), with 80-85% mortality in the first year of life or CX coursing between the aorta and pulmonary trunk as well as the right coronary artery originating from the left sinus of Valsalva. Circumflex branch originating from the right coronary artery (RCA) or the right sinus of Valsalva is the most common CAA, found in 0.48% of the population of patients undergoing angiography [10]. Abnormal CX may begin with a separate (37%) or common (23%) origin with the RCA or arise from a proximal segment of the RCA (40%) [11]. Abnormal retroaortic segment of the vessel seems to be particularly predisposed to atherosclerosis but may be successfully treated with coronary angioplasty. On the other hand, CX origin from non-coronary sinus is a unique anomaly, detectable by transoesophageal echocardiography, which has been reported as a useful method allowing tomographic visualization of proximal coronary arteries. Preliminary diagnosis of coronary artery anomaly on the basis of echocardiographic examination allows one to reduce contrast and radiation exposure during angiography and thus possibly avoid some complications including contrast-induced nephropathy [12]. Patients with clinically significant type of CAA may benefit from appropriate medical or surgical treatment. Transthoracic echocardiography may be used for efficient postoperative outcome evaluation and long-term follow-up. High-quality echocardiographic visualization of the stenotic arterial site allows quantification based on turbulent flow detection, velocity [13, 14] and lumen diameter measurement, and functional tests (stress echocardiography). Transthoracic examination is proven to be an accurate method to evaluate coronary artery diameter in patients with healthy coronary arteries [15]. At least doubling of maximal flow velocity within stenosis with regard to maximal flow velocity proximal to stenosis or local maximal flow velocity > 1.5 m/s is proposed to be a reliable sign of > 50% coronary artery stenosis. When coronary angiography reveals LAD stenosis of intermediate severity, the measurement of CFR using transthoracic Doppler provides assessment of its functional importance with CFR value > 2 justifying postponement of interventional treatment. Coronary flow reserve is thus a useful method for functional assessment of complex coronary pathophysiology. The limitations of our report include the lack of invasive assessment of fractional flow reserve (FFR) in the LAD and CX, which would be interesting to compare with echocardiographic CFR measurements. It must be noted that distal CX stenosis was not detectable in transthoracic echocardiography. In conclusion, coronary angiography remains a gold standard for the evaluation of coronary anatomy. Nevertheless, carefully performed transthoracic echocardiographic examination of coronary arteries may be considered as a complementary non-invasive method providing extended physiological information and enabling non-invasive follow-up in selected patients.

Objectives We investigated the outcomes of switching to bivalirudin after initial administration of heparin in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention. Background Unfractionated heparin (UFH) is frequently administered early in ST-segment elevation myocardial infarction. Whether the benefits of bivalirudin documented in the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trial persist in patients previously administered UFH is unknown. Methods We analyzed the outcomes of the 2,357 patients from HORIZONS-AMI treated with UFH before enrollment according to their subsequent randomization to bivalirudin (switch group, n = 1,178) or UFH plus a glycoprotein IIb/IIIa inhibitor (control group, n = 1,179). Results At 30 days, major bleeding occurred in 7.6% of the switch group versus 12.3% of the control group (p = 0.0001). Switch patients had lower 30-day rates of cardiac mortality (1.6% vs. 2.9%, p = 0.04). At 2-year follow-up, switch patients experienced lower rates of major bleeding (8.4% vs. 13.0%, p = 0.0003), cardiac mortality (2.3% vs. 3.8%, p = 0.04), and reinfarction (4.0% vs. 7.1%, p = 0.0002). Two-year rates of definite/probable stent thrombosis were similar in switch and control patients (3.1% vs. 4.3%, p = 0.17). Conclusions In ST-segment elevation myocardial infarction patients who receive early treatment with UFH, switching to bivalirudin before primary percutaneous coronary intervention results in reduced rates of major bleeding and improved early and late cardiac survival.

Background: Acute coronary syndrome without ST segment elevation (NSTEMI) in patients with diabetes mellitus (DM) has poor prognosis and percutaneous coronary intervention (PCI) is the best treatment strategy. However, there are no clear guidelines concerning the choice of optimal invasive treatment strategy. Aim: To evaluate the restenosis rate in patients with NSTEMI and DM depending on the kind of implanted stent. Material and methods: The study group comprised 984 NSTEMI patients hospitalized in the 2nd Department of Cardiology. 352 patients received a bare metal stent (BMS), while 632 pts received a drug-eluting stent (DES) – 238 pts a paclitaxel-eluting stent (PES) and 394 a sirolimus-eluting stent (SES). There were no statistically significant differences concerning age of the groups. Results: After 1-year follow-up there were no significant mortality differences – 7.9% in the BMS group, 8.8% in the PES group and 8.1% in the SES group. There were 6 in-hospital deaths, one in the BMS and PES groups and 4 in the SES group. After 1-year follow-up there were significant restenosis rate differences: 8.24% in the BMS group, 8.4% in the PES group and 6.34% in the SES group (p = 0.003). Stent thrombosis was a rare complication and occurred in 10 patients without differences in stent groups. The predictors of restenosis revealed by univariate logistic regression analysis included female gender, lipid disturbances (p < 0.001), past myocardial infarction (p < 0.001) and peripheral arterial disease (p < 0.001). Conclusions: Percutaneous coronary angioplasty in patients with NSTEMI and coexisting DM is effective and safe. Implantation of sirolimus-eluting stents gives the best long-term results expressed as the lowest restenosis rate.

Background: Transcatheter closure of patent foramen ovale (PFO) and atrial septal defect (ASD) are procedures commonly performed in recent years. Aim: To assess long-term results of percutaneous closure of ASD and PFO in adult patients. Material and methods: The study group comprised 64 patients (45 women, mean age 50.5 ±12.7 years), who in 2004-2010 underwent percutaneous closure of ASD or PFO. The occurrence of clinical end-points in the follow-up and possible changes in quality of life and echocardiographic parameters were taken into consideration. Results: In a mean follow-up period of 310 ±305 days there were no deaths or recurrent neurological or peripheral embolic events. In patients with PFO there was no minimal residual shunt immediately after the procedure in transthoracic and transoesophageal echocardiography, while in patients with ASD early closure of the shunt (up to 24 h) was achieved in 64% of patients, and after 8 months of observation in 84%. The majority of patients were free of complications after the procedure, but one patient underwent urgent surgery after dislocation of the device within 3 h of the procedure and two patients were diagnosed with new-onset atrial fibrillation (AF) about one month after the procedure. Telephone survey revealed that most patients (81% of patients with ASD and 29% of patients with PFO) noted a marked improvement in health status, relief of symptoms of heart failure, syncope and other symptoms experienced prior to the procedure. Conclusions: Transcatheter closure of ASD and PFO is a safe and effective procedure. Moreover, a significant improvement of quality of life can be observed.

Objectives The FINESSE-ANGIO (Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events–Angiographic) study evaluated acute treatment effects on infarct-related artery (IRA) patency and angiographic correlates of coronary microcirculatory function. Background The FINESSE trial evaluated the effects on clinical outcomes of primary percutaneous coronary intervention (PCI) facilitated with pre–catheterization laboratory administration of abciximab with half-dose reteplase (combination-facilitated group), abciximab alone (abciximab-facilitated group), or with abciximab administered immediately before the procedure (primary PCI). Methods The FINESSE-ANGIO substudy compared the effects of the 3 treatment strategies on patency (TIMI [Thrombolysis In Myocardial Infarction] flow grade 2/3) of the IRA at basal coronary angiography. The secondary efficacy end points were corrected TIMI frame count, percentage of patients achieving TIMI flow grade 3, and the percentage achieving myocardial blush grade 2/3 of the IRA at post-PCI angiography. All angiographies were evaluated at a central core laboratory. Results Of the 2,452 FINESSE patients, 637 were included in the FINESSE-ANGIO substudy. Patients in the combination-facilitated group exhibited significantly higher rates of baseline IRA patency compared with the abciximab-facilitated and the primary PCI groups (76.1% vs. 43.7% and 32.7%, respectively; p Conclusions Pre–catheterization laboratory administration of abciximab alone and especially in combination with half-dose reteplase resulted in higher rates of IRA patency at baseline coronary angiography compared with no pre-treatment. However, post-procedural angiographic and microcirculatory variables were unaffected by facilitation therapy.

Objectives We sought to identify patients with ST-segment elevation myocardial infarction most likely to benefit from drug-eluting stents (DES), and to evaluate the impact of routine angiographic follow-up on the apparent differences between stent types. Background DES might have greatest utility in patients who would benefit most from their antirestenotic properties. Methods We randomly assigned 3,006 patients with ST-segment elevation myocardial infarction to paclitaxel-eluting stents (PES) or to bare-metal stents (BMS). Events were assessed at 12 months and 24 months, with a subset undergoing routine angiographic follow-up at 13 months. Using well-known risk factors for restenosis and target lesion revascularization (TLR), risk groups were formed to examine the absolute differences between PES and BMS. Results Compared with BMS, PES reduced TLR at 12 months from 7.4% to 4.5% (p = 0.003). Insulin-treated diabetes mellitus (hazard ratio: 3.12), reference vessel diameter ≤3.0 mm (hazard ratio: 2.89), and lesion length ≥30 mm (hazard ratio: 2.49) were independent predictors of 12-month TLR after BMS. In patients with 2 or 3 of these baseline risk factors, PES compared with BMS markedly reduced 12-month TLR (19.8% vs. 8.1%, p = 0.003). In patients with 1 of these risk factors, the 12-month rates of TLR were modestly reduced by PES (7.3% vs. 4.3%, p = 0.02). The 12-month TLR rates were low and similar for both stents in patients with 0 risk factors (3.3% vs. 3.2%, p = 0.93). Routine 13-month angiographic follow-up resulted in a marked increase in TLR procedures (more so with BMS) so that the absolute incremental benefit of PES compared with BMS doubled from 2.9% at 12 months to 6.0% at 24 months, a difference evident in all risk strata. Conclusions Patients at high risk for TLR after BMS in ST-segment elevation myocardial infarction for whom DES are of greatest benefit may be identified. Conversely, DES may be of less clinical benefit for patients at lower risk for TLR after BMS. Routine angiographic follow-up increases the perceived clinical benefits of DES, and must be avoided to accurately estimate absolute treatment effects. (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction [HORIZONS-AMI]; NCT00433966 )

Objectives: This study sought to assess the relationship between 1-year mortality and baseline patient risk in the HORIZONS-AMI (Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myoc...

Objectives Our objective was to evaluate the impact of door-to-balloon time (DBT) on mortality depending on clinical risk and time to presentation. Background DBT affects the mortality rate in ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention, but the impact may vary across subgroups. Methods The CADILLAC (Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications) and HORIZONS-AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) trials evaluated stent and antithrombotic therapy in patients undergoing primary percutaneous coronary intervention. We studied the impact of DBT on mortality in 4,548 patients based on time to presentation and clinical risk. Results The 1-year mortality rate was lower in patients with short versus long DBT (≤90 min vs. >90 min, 3.1% vs. 4.3%, p = 0.045). Short DBTs were associated with a lower mortality rate in patients with early presentation (≤90 min: 1.9% vs. 3.8%, p = 0.029) but not those with later presentation (>90 min: 4.0% vs. 4.6%, p = 0.47). Short DBTs showed similar trends for a lower mortality rate in high-risk (5.7% vs. 7.4%, p = 0.12) and low-risk (1.1% vs. 1.6%, p = 0.25) patients. Short DBTs had similar relative risk reductions in patients with early presentation in high-risk (3.7% vs. 7.0%, p = 0.08) and low-risk (0.8% vs. 1.5%, p = 0.32) patients, although the absolute benefit was greatest in high-risk patients. Conclusions Short DBTs (≤90 min) are associated with a lower mortality rate in patients with early presentation but have less impact on the mortality rate in patients presenting later. The absolute mortality rate reduction with short DBT is greatest in high-risk patients presenting early. These data may be helpful in designing triage strategies for reperfusion therapy in patients presenting to non–percutaneous coronary intervention hospitals.

Objectives The aim of this report was to evaluate 12-month outcomes of facilitated percutaneous coronary intervention (PCI) in the FINESSE (Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events) trial. Background Treatment delays remain common for patients with primary PCI leading to studies evaluating possible benefit of “facilitated” PCI. In the FINESSE trial, no reduction in the 90-day primary ischemic end point and an increase in bleeding were observed with both facilitated approaches, although modest favorable trends were seen for some patient subgroups. Methods A total of 2,452 patients with ST-segment elevation myocardial infarction (MI) and anticipated 1 to 4 h delay until catheterization were randomized to reduced-dose reteplase + abciximab, abciximab alone, or placebo, followed by expedited primary PCI. Placebo-treated patients received abciximab in the cath lab. One-year mortality was a pre-specified secondary end point. Results One-year mortalities in the 3 groups noted in the preceding text were 6.3%, 7.4%, and 7.0%, respectively (p = NS), representing 1.1%, 1.9%, and 2.5% increments since the 90-day outcome (p = 0.053 for combination treatment vs. primary PCI). A favorable trend with combination treatment was seen for patients with anterior MI (p = 0.09), but no other specified groups benefited or tended to benefit. Independent baseline correlates of 1-year mortality were systolic blood pressure 1, anterior MI, body mass index ≤25 kg/m2, heart rate >100 beats/min, and no statin use. Conclusions These results suggest that widespread utilization of the facilitated approaches tested cannot be justified, but that high-risk patient groups such as patients with anterior MI may deserve further study. (The FINESSE trial; NCT00046228 )

Objectives Our aim was to determine whether a 600-mg loading dose of clopidogrel compared with 300 mg results in improved clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Background A 600-mg loading dose of clopidogrel compared with 300 mg provides more rapid and potent inhibition of platelet activation. Methods In the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trial, 3,602 patients with STEMI undergoing primary PCI were randomized to bivalirudin (n = 1,800) or unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor (n = 1,802). Randomization was stratified by thienopyridine loading dose, which was determined before random assignment. Results Patients in the 600-mg (n = 2,158) compared with the 300-mg (n = 1,153) clopidogrel loading dose group had significantly lower 30-day unadjusted rates of mortality (1.9% vs. 3.1%, p = 0.03), reinfarction (1.3% vs. 2.3%, p = 0.02), and definite or probable stent thrombosis (1.7% vs. 2.8%, p = 0.04), without higher bleeding rates. Compared with unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor, bivalirudin monotherapy resulted in similar reductions in net adverse cardiac event rates within the 300-mg (15.2% vs. 12.3%) and 600-mg (10.4% vs. 7.3%) clopidogrel loading dose subgroups (pinteraction= 0.41). By multivariable analysis, a 600-mg clopidogrel loading dose was an independent predictor of lower rates of 30-day major adverse cardiac events (hazard ratio: 0.72 [95% confidence interval: 0.53 to 0.98], p = 0.04). Conclusions In patients with STEMI undergoing primary PCI with contemporary anticoagulation regimens, a 600-mg loading dose of clopidogrel may safely reduce 30-day ischemic adverse event rates compared with a 300-mg loading dose. (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction [HORIZONS-AMI]; NCT00433966)

Aims The aim of this analysis was to examine the influence of different in-cath-lab antiplatelet regimens for the primary percutaneous coronary intervention (PCI) on all-cause mortality. Methods and results The study group consisted of 7193 patients (pts) undergoing primary PCI in 38 centres in 2003 in Poland. All patients received pretreatment with 300 mg of aspirin, 992 pts (14%) received glycoprotein (GP) IIb/IIIa inhibitors, 2690 pts (37%) were treated with 300 mg loading dose of clopidogrel, and 1566 (22%) received combined antiplatelet treatment with both GP IIb/IIIa inhibitors and clopidogrel. Remaining 1945 patients (27%) did not receive GP IIb/IIIa inhibitors or clopidogrel. Primary endpoint of the study was all-cause mortality up to 1 year from ST-segment elevation myocardial infarction (STEMI). One year mortality rates in the four groups were: 10.4%, 9.0%, 9.7%, and 15.3%, respectively. Propensity-adjusted survival analysis showed significant reduction of mortality for combination therapy with GP IIb/IIIa inhibitors and clopidogrel, clopidogrel alone, and GP IIb/IIIa inhibitors alone over aspirin alone. No additive effect on survival was seen for a combination therapy with GP IIb/IIIa inhibitors and clopidogrel in comparison to treatment with clopidogrel alone. Conclusion In this large cohort, multicentre STEMI registry in-cath-lab use of GP IIb/IIIa inhibitors and clopidogrel alone or in combination was associated with the reduction of 1 year all-cause mortality in the setting of primary PCI in comparison with aspirin only. However, the use of GP IIb/IIIa inhibitors on top of 300 mg loading dose of clopidogrel did not further reduce mortality.

Udgivelsesdato: 2008-May-22 BACKGROUND: We hypothesized that percutaneous coronary intervention (PCI) preceded by early treatment with abciximab plus half-dose reteplase (combination-facilitated PCI) or with abciximab alone (abciximab-facilitated PCI) would improve outcomes in patients with acute ST-segment elevation myocardial infarction, as compared with abciximab administered immediately before the procedure (primary PCI). METHODS: In this international, double-blind, placebo-controlled study, we randomly assigned patients with ST-segment elevation myocardial infarction who presented 6 hours or less after the onset of symptoms to receive combination-facilitated PCI, abciximab-facilitated PCI, or primary PCI. All patients received unfractionated heparin or enoxaparin before PCI and a 12-hour infusion of abciximab after PCI. The primary end point was the composite of death from all causes, ventricular fibrillation occurring more than 48 hours after randomization, cardiogenic shock, and congestive heart failure during the first 90 days after randomization. RESULTS: A total of 2452 patients were randomly assigned to a treatment group. Significantly more patients had early ST-segment resolution with combination-facilitated PCI (43.9%) than with abciximab-facilitated PCI (33.1%) or primary PCI (31.0%; P=0.01 and P=0.003, respectively). The primary end point occurred in 9.8%, 10.5%, and 10.7% of the patients in the combination-facilitated PCI group, abciximab-facilitated PCI group, and primary-PCI group, respectively (P=0.55); 90-day mortality rates were 5.2%, 5.5%, and 4.5%, respectively (P=0.49). CONCLUSIONS: Neither facilitation of PCI with reteplase plus abciximab nor facilitation with abciximab alone significantly improved the clinical outcomes, as compared with abciximab given at the time of PCI, in patients with ST-segment elevation myocardial infarction. (ClinicalTrials.gov number, NCT00046228 [ClinicalTrials.gov].)

Background: Myocardial perfusion single-photon emission computed tomography (SPECT) is one of the basic tools used for the purpose of diagnosis of coronary artery disease (CAD), prognosis of its unfavourable consequences, and evaluation of therapy effectiveness. However, its efficacy is compromised by a relatively low specificity of detection of perfusion defects, which is attributed to attenuation of gamma rays inside the patient’s body, causing artefacts erroneously taken for perfusion defects. It is expected that attenuation correction (AC) could eliminate such artefacts. Aim: To evaluate whether visual, semi-quantitative analysis of attenuation-corrected myocardial perfusion imaging provides an advantage over a non-corrected study. Methods: A retrospective study applying AC was performed in 107 patients who had coronary angiography within three months. Patients underwent a stress/rest Tc-99m methoxyisobutylisonitrile (MIBI, POLATOM) double day SPECT/CT myocardial perfusion imaging. Images were analysed by two experienced nuclear medicine specialists (a consensus) applying a visual semiquantitative method. Coronary angiography findings were used as a reference for the analysis of diagnostic performance of myocardial perfusion study protocols. Results: AC increased the specificity of detection of CAD in the whole group of patients from 63% to 86% (p = 0.0005), with a slight reduction in sensitivity (from 83% to 79%). The improved specificity was also noted in subgroups of male and female patients. Accuracy in the whole group of patients increased from 71% to 83% (p = 0.01). AC improved the specificity and accuracy of the method in the detection of perfusion defects in the right coronary artery (RCA) area from 73% to 88% (p = 0.005) and from 74% to 83% (p = 0.04), respectively, and the accuracy of the method in the left anterior descending (LAD) artery area from 79% to 87% (p = 0.043). It also reduced the number of ambiguous results of the study. Conclusions: AC improved the diagnostic performance of myocardial perfusion study in the detection of CAD and identification of critically stenosed LAD and RCA vessels, with enhanced comfort of study interpretation.

(2016). Unusual sequel of dual-chamber ICD implantation. Acta Cardiologica: Vol. 71, No. 5, pp. 623-624.