Pre-hospital delay, clinical characteristics, angiographic findings, and in-hospital mortality in young and middle-aged adults with acute coronary syndrome: a single-centre registry analysis.

There are several differences between younger and older adults with acute coronary syndrome (ACS). However, few studies have evaluated these differences. We analysed the pre-hospital time interval [symptom onset to first medical contact (FMC)], clinical characteristics, angiographic findings, and in-hospital mortality in patients aged ≤50 (group A) and 51-65 (group B) years hospitalised for ACS. We retrospectively collected data from 2010 consecutive patients hospitalised with ACS between 1 October 2018 and 31 October 2021 from a single-centre ACS registry. Groups A and B included 182 and 498 patients, respectively. ST-segment elevation myocardial infarction (STEMI) was more common in group A than group B (62.6 and 45.6%, respectively; P < 0.001). The median time from symptom onset to FMC in STEMI patients did not significantly differ between groups A and B [74 (40-198) and 96 (40-249) min, respectively; P = 0.369]. There was no difference in the rate of sub-acute STEMI (symptom onset to FMC > 24 h) between groups A and B (10.4% and 9.0%, respectively; P = 0.579). Among patients with non-ST elevation acute coronary syndrome (NSTE-ACS), 41.8 and 50.2% of those in groups A and B, respectively, presented to the hospital within 24 h of symptom onset (P = 0.219). The prevalence of previous myocardial infarction was 19.2% in group A and 19.5% in group B (P = 1.00). Hypertension, diabetes, and peripheral arterial disease were more common in group B than group A. Active smoking was more common in group A than group B (67 and 54.2%, respectively; P = 0.021). Single-vessel disease was present in 52.2 and 37.1% of participants in groups A and B, respectively (P = 0.002). Proximal left anterior descending artery was more commonly the culprit lesion in group A compared with group B, irrespective of the ACS type (STEMI, 37.7 and 24.2%, respectively; P = 0.009; NSTE-ACS, 29.4 and 21%, respectively; P = 0.140). The hospital mortality rate for STEMI patients was 1.8 and 4.4% in groups A and B, respectively (P = 0.210), while for NSTE-ACS patients it was 2.9 and 2.6% in groups A and B, respectively (P = 0.873). No significant differences in pre-hospital delay were found between young (≤50 years) and middle-aged (51-65 years) patients with ACS. Although clinical characteristics and angiographic findings differ between young and middle-aged patients with ACS, the in-hospital mortality rate did not differ between the groups and was low for both of them.

Comparison of a Bioresorbable, Magnesium-Based Sirolimus-Eluting Stent with a Permanent, Everolimus-Eluting Metallic Stent for Treating Patients with Acute Coronary Syndrome: the PRAGUE-22 Study.

BACKGROUND: Magnesium-based bioresorbable Magmaris stents are rapidly resorbed. Few randomized studies have evaluated the efficacy of such stents in patients with acute coronary syndrome. AIM: To investigate late lumen loss as assessed via quantitative coronary angiography (QCA) and optical coherence tomography (OCT) in patients with acute coronary syndrome treated with Magmaris stents or permanent, everolimus-eluting metallic Xience stents. METHODS AND RESULTS: This PRAGUE-22 study was a two-centre, investigator-initiated, randomized study. Fifty patients were randomized based on the inclusion criteria for acute coronary syndrome and the anatomical suitability to receive Magmaris or Xience stents. The patient characteristics did not differ between the Magmaris group (n = 25) and Xience group (n = 25). The mean ages were 57.0 ± 10.5 vs. 55.5 ± 9.2 years (p = 0.541) and the total implanted stent length was 24.6 ± 10.7 mm vs. 27.6 ± 11.1 mm (p = 0.368), respectively. Four clinical events occurred in the Magmaris group and one in the Xience group during 12 months of follow-up. The extent of late lumen loss (assessed via QCA) at 12 months was greater in the Magmaris group than in the Xience group (0.54 ± 0.70 vs. 0.11 ± 0.37 mm; p = 0.029). The late lumen loss diameter (measured via OCT) in the Magmaris group was also significantly larger than that in the Xience group (0.59 ± 0.37 vs. 0.22 ± 0.20 mm; p = 0.01). CONCLUSION: Implantation of a magnesium-based bioresorbable stent in patients with acute coronary syndrome is associated with a greater extent of late lumen loss at the 12-month follow-up compared with implantation of a permanent, everolimus-eluting metallic stent. TRIAL REGISTRATION: ISRCTN89434356.

Long-term follow-up in patients with ST-segment elevation myocardial infarction who underwent primary percutaneous coronary intervention.

Long-term follow-up after primary percutaneous coronary intervention (pPCI) for ST-segment elevation myocardial infarction (STEMI) beyond 5 years is poorly described. There are no risk-stratification systems available for routine use. This retrospective, academic, two-centre analysis included consecutive patients who presented with acute STEMI between March 2008 and December 2019. In total, 5263 patients underwent pPCI; all patients were included in the analysis only once. Baseline characteristics were gathered from prospective local registries and based on initial hospitalization. The study enrolled 5263 patients who had been treated with pPCI; it found that cardiovascular mortality was the most frequent cause of death (65.0%) on long-term follow-up to 12 years. Myocardial infarction associated mortality was 27.2%. Cardiovascular mortality was dominant, including in the landmark analysis beyond 1 year. Multivariate analysis identified significant predictors for long-term cardiovascular mortality: age, history of diabetes mellitus, history of renal insufficiency, history of heart failure, Killip class, and successful pPCI at presentation. A predictive model was built to evaluate the risk of cardiovascular death with a high discrimination value (C-statistic = 0.84). Cardiovascular diseases remain the leading cause of long-term mortality after pPCI in the Central European population. Our novel predictive model provides risk stratification; it could identify patients who would experience the greatest benefit from aggressive secondary prevention measures.

Fully automated measurement of aortic root anatomy using Philips HeartNavigator computed tomography software: fast, accurate, or both?

Cardiac computed tomography (CT) is vital for safety and efficacy of transcatheter aortic valve implantation (TAVI). We aimed to determine the accuracy of fully automated CT analysis of aortic root anatomy before TAVI by Philips HeartNavigator software. This prospective, academic, single-centre study enrolled 128 consecutive patients with native aortic valve stenosis considered for TAVI. Automated HeartNavigator software was compared to the standard manual CT analysis by experienced operators using FluoroCT software. The sizing of the aortic annulus by perimeter and area significantly differed between both methods: mean perimeter was 76.43 mm vs. 77.52 mm (P < 0.0001) using manual FluoroCT vs. automated HeartNavigator software; mean area was 465 mm2 vs. 476 mm2 (P < 0.0001). Interindividual variability testing revealed mean differences between the two operators were 1.21 mm for the aortic annulus perimeter and 9 mm2 for the aortic annulus area. The hypothetical self-expandable transcatheter prosthesis sizing resulted in 80% agreement in 80% of cases. The time required to perform the automated CT analysis was significantly shorter than the time required for manual analysis (mean 17.8 min vs. 2.1 min, P < 0.0001). Philips HeartNavigator fully automated software for pre-TAVI CT analysis is a promising technology. Differences detected in aortic annulus dimensions are small and similar to the variability of manual CT analysis. Automated prediction of optimal fluoroscopic viewing angles is accurate. Correct transcatheter prosthesis sizing requires clinical oversight.

Predictors allowing early discharge after interventional treatment of acute coronary syndrome patients.

Many scoring systems for predicting the outcomes of patients with acute coronary syndrome (ACS) have been proposed. In some populations, a significant reduction in length of hospital stay may be achieved without compromising patient prognoses. However, the use of such scoring systems in clinical practice is limited. The aim of this study was to propose a universal list of predictors that can identify low-risk ACS patients who may be eligible for an earlier hospital discharge without increased short-term risk for major adverse cardiac events. A cohort of 1420 patients diagnosed with ACS were enrolled into a single-centre registry between October 2018 and December 2020. Clinical, laboratory, echocardiographic, and angiographic measurements were taken for each patient and entered into the study database. Using retrospective univariant analyses of patients treated with percutaneous coronary intervention (PCI) (n = 932), we compared each predictor to 30-day mortality rate using the Czech national registry of dead people. Eleven predictors correlate significantly with 30-day survival: age <80 years, ejection fraction >50%, no cardiopulmonary resuscitation, no mechanical ventilation needed, Killip class I at admission, haemoglobin levels >110 g/L while hospitalized, successful PCI procedure(s), no residual stenosis over 90%, Thrombolysis in Myocardial Infarction 3 flow after PCI, no left main stem disease, and no triple-vessel coronary artery disease. In all, presence of all predictors applies to 328 patients (35.2% of the cohort), who maintained a 100% survival rate at 30 days. A combination of clinical, echocardiographic, and angiographic findings provides valuable information for predicting the outcomes of patients with all types of ACS. We created a simple, useful tool for selecting low-risk patients eligible for early discharge.

Patient characteristics, treatment strategy, outcomes, and hospital costs of acute coronary syndrome: 3 years of data from a large high-volume centre in Central Europe.

Managing patients with acute coronary syndrome (ACS) in an ageing population with comorbidities is clinically and economically challenging. Well-conducted unselected registries are essential for providing information on real-day clinical practice. The aim was to create a long term, very detail-controlled registry of unselected patients admitted with ACS to a high-volume centre in Central Europe. Consecutive patients admitted with confirmed ACS were entered into the prospective registry from 1 October 2018 to 30 September 2021. Data on 214 parameters, including clinical characteristics, angiographic findings, laboratory and therapeutic findings, financial costs, and in-hospital mortality, were obtained for all patients. Analyses were performed on the complete dataset of 1804 patients. Of these patients, 694 (38.5%) were admitted for ST-segment elevation myocardial infarction (STEMI) and 1110 (61.5%) were admitted for non-ST-elevation (NSTE)-ACS [779 with NSTE myocardial infarction (NSTE-MI) and 331 with unstable angina (UA)]. Almost all patients (99%) underwent coronary angiography. Primary percutaneous coronary intervention (PCI) was performed in 93.4% of STEMI patients and 74.5% of NSTE-ACS patients. Patients with NSTE-MI had the longest total hospital stay (8.1 ± 9.1 days) and highest financial costs (8579.5 ± 7173.2 euros). In-hospital mortality was 1.2% in UA, 6.2% in NSTE-MI, and 10.9% in STEMI patients. Age older than 75 years, pre-hospital cardiac arrest and/or mechanical ventilation, subacute STEMI, and ejection fraction below 40% were the most powerful predictors of in-hospital mortality as assessed by multivariate analyses. The in-hospital mortality of unselected NSTE-MI and STEMI patients in daily practice is not low despite very good implementation of guideline-recommended therapy with a high rate of revascularization. The highest financial costs are associated with NSTE-MI.

Nurse-led sedation for transfemoral transcatheter aortic valve implantation seems safe for a selected patient population.

Transcatheter aortic valve implantation (TAVI) has become a high-volume procedure with increasing demands on hospital resources. Local anaesthesia with sedation supervised by an anaesthesiology team is the current standard of care. We aimed to describe our experience with a simplified, nurse-led sedation (NLS) protocol. This study enrolled 128 consecutive patients who underwent transfemoral TAVI with self-expandable Evolut R prosthesis between November 2019 and April 2021. Operators selected 50% of patients for NLS based on the clinical expectation of lower risk of procedural difficulties. Nurse-led sedation protocol demanded only mild to moderate levels of sedation. The clinical outcomes were determined from the local TAVI registry and the national mortality database. Baseline patient characteristics were similar in the NLS (n = 64) and anaesthesiologist-led sedation (ALS) (n = 64) groups except higher prevalence of diabetes mellitus (48.4% vs. 31.3%, P = 0.035) and peripheral vascular disease (20.3% vs. 7.8%, P = 0.036) in the ALS group. There was a trend for the larger prostheses used in the ALS group (P = 0.058). The procedural results did not differ, and coronary care team backup was rarely needed in the NLS group (6% of patients). The in-hospital outcomes were identical from both clinical and echocardiography perspectives, and 30-day mortality was low in both groups (1.5%). For the NLS group, preparation in the catheterization laboratory was quicker by 6.4 min (P = 0.01), and intensive care unit stay was shorter (2.03 vs. 3.48 days, P = 0.001). In conclusion, the NLS for the selected transfemoral TAVI population seems safe.

Bioresorbable scaffold implantation in STEMI patients: 5 years imaging subanalysis of PRAGUE-19 study.

BACKGROUND: Bioresorbable scaffold (BRS) Absorb™ clinical use has been stopped due to higher rate of device thrombosis. Scaffold struts persist longer than 2 years in the vessel wall. Second generation devices are being developed. This study evaluates long-term invasive imaging in STEMI patients. METHODS: PRAGUE-19 study is an academic study enrolling consecutive STEMI patients with intention to implant Absorb™ BRS. A total of 83 STEMI patients between December 2012 and March 2014 fulfilled entry criteria. Coronary angiography and optical coherence tomography at 5 year follow-up was performed in 25 patients. RESULTS: Primary combined clinical endpoint (death, myocardial infarction or target vessel revascularization) occurred in 12.6% during the five-year follow-up with overall mortality 6.3%. Definite scaffold thrombosis occurred in 2 patients in the early phase after BRS implantation. Quantitative coronary angiography after 5 years demonstrated low late lumen loss of 0.11 ± 0.35 mm with binary restenosis rate of 0%. Optical coherence tomography demonstrated complete resorption of scaffold struts and mean lumen diameter of 3.25 ± 0.30 and 3.22 ± 0.49 (P = 0.73) at baseline and after 5 years, respectively. Three patients developed small coronary artery aneurysm in the treated segment. CONCLUSION: Invasive imaging results 5 years after BRS implantation in STEMI showed complete resorption of scaffold struts and stable lumen vessel diameter. Trial registration ISRCTN43696201 (retrospectivelly registred, June 7th, 2019). https://www.isrctn.com/ISRCTN43696201.

Real-World Dual Antiplatelet Therapy Following Polymer-Free Sirolimus-Eluting Stent Implantations to Treat Coronary Artery Disease.

OBJECTIVES: The objective of this post hoc analysis was to analyze real-world dual antiplatelet therapy (DAPT) regimens following polymer-free sirolimus-eluting stent (PF-SES) implantations in an unselected patient population. METHODS: Patient-level data from two all-comers observational studies (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were pooled and analyzed in terms of their primary endpoint. During the data verification process, we observed substantial deviations from DAPT guideline recommendations. To illuminate this gap between clinical practice and guideline recommendations, we conducted a post hoc analysis of DAPT regimens and clinical event rates for which we defined the net adverse event rate (NACE) consisting of target lesion revascularization (TLR, primary endpoint of all-comers observational studies) all-cause death, myocardial infarction (MI), stent thrombosis (ST), and bleeding events. A logistic regression was utilized to determine predictors why ticagrelor was used in stable coronary artery disease (CAD) patients instead of the guideline-recommended clopidogrel. RESULTS: For stable CAD, the composite endpoint of clinical, bleeding, and stent thrombosis, i.e., NACE, between the clopidogrel and ticagrelor treatment groups was not different (5.4% vs. 5.1%, p = 0.745). Likewise, in the acute coronary syndrome (ACS) cohort, the NACE rates were not different between both DAPT strategies (9.2% vs. 9.3%, p = 0.927). There were also no differences in the accumulated rates for TLR, myocardial infarction ([MI], mortality, bleeding events, and stent thrombosis in elective and ACS patients. The main predictors for ticagrelor use in stable CAD patients were age < 65 years, smaller vessels, treatment of ostial and calcified lesions, and in-stent restenosis. CONCLUSION: Within the framework of a post hoc analysis based on a real-world, large cohort study, there were no differences in the combined endpoint of major adverse cardiac events (MACE), bleeding and thrombotic events for clopidogrel and ticagrelor in stable CAD or ACS patients. Despite the recommendation for clopidogrel by the European Society of Cardiology (ESC), real-world ticagrelor use was observed in subgroups of stable CAD patients that ought to be explored in future trials.

Intravascular haemolysis after transcatheter aortic valve implantation with self-expandable prosthesis: incidence, severity, and impact on long-term mortality.

We aimed to determine the incidence, severity, and long-term impact of intravascular haemolysis after self-expanding transcatheter aortic valve implantation (TAVI). We believe this should be evaluated before extending the indications of TAVI to younger low-risk patients. Prospective, academic, single centre study of 94 consecutive patients treated with supra-annular self-expandable TAVI prosthesis between April 2009 and January 2014. Haemolysis at 1-year post-TAVI was defined per the published criteria based on levels of haemoglobin, reticulocyte and schistocyte count, lactate dehydrogenase (LDH), and haptoglobin. All patients had long-term clinical follow-up (6 years). The incidence of haemolysis at 1-year follow-up varied between 9% and 28%, based on different haemolysis definitions. Haemolysis was mild in all cases, no patient had markedly increased LDH levels. The presence of moderate/severe paravalvular aortic regurgitation was associated with haemolysis (7.7% vs. 23.1%, P = 0.044) and aortic valve area post-TAVI did not differ between groups with or without haemolysis (1.01 vs. 0.92 cm2/m2, P = 0.23) (definition including schistocyte count). The presence of haemolysis did not have any impact on patient prognosis after 6 years with log-rank test P = 0.80. Intravascular haemolysis after TAVI with self-expandable prosthesis is present in 9-28% of patients depending on the definition of haemolysis. The presence of haemolysis is associated with moderate/severe paravalvular aortic regurgitation but not with post-TAVI aortic valve area. Haemolysis is mild with no impact on prognosis.

Transcatheter aortic valve implantation - what do we know in 2020.

stenosis is the most common acquired valve disease in adults and the prevalence of this disease is increasing with the aging population. Transcatheter aortic valve implantation (TAVI) became fully established method for treating this disease. The aim of this review is to present the current view of the performance technique, to summarize the data on the outcome of patients from recently published randomized studies and registries and to simply describe patient care after the procedure.

Immune-inflammatory response after bioresorbable vascular scaffold implantation in patients with acute myocardial infarction with ST elevation in a long-term perspective.

A higher rate of bioresorbable vascular scaffold (BVS) thrombosis has been observed after device implantation compared to implantation of permanent metallic stents in recently published studies. The mechanism of BVS thrombosis is currently under debate. To assess whether the immune-inflammatory response after BVS implantation is a potential trigger of BVS thrombosis. The PRAGUE-19 study was an academic study that enrolled consecutive patients with ST-segment elevation myocardial infarction (STEMI) with the intention to implant a BVS. A laboratory sub-study included 49 patients with an implanted BVS (of which 38 underwent the complete 2-year follow-up) and 52 patients having an implanted permanent metallic stent as the control group (of which 30 underwent the complete 2-year follow-up). Samples for inflammatory markers [high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α)] were taken before BVS or stent implantation, on days 1 and 2 after device implantation and at 1 month and 2 years for a clinical control. The primary combined clinical endpoint of the sub-study (death, reinfarction or target vessel revascularization) occurred in 4.08% of the BVS group and 7.69% of the control group (p = 0.442) during the 2-year follow-up period, with overall mortality of 2.04% in the BVS group and 1.92% in the control group (p = 0.966). Definite BVS thrombosis occurred in one patient in the subacute phase; there was no late or very late thrombosis. Two definite stent thromboses were observed in the control group: one in the subacute phase and the other in the late phase. Baseline inflammatory marker levels did not differ between the groups. Lower levels of IL-6 and hs-CRP were observed in the BVS group compared to the control group (12.02 ± 5.94 vs. 15.21 ± 5.33 pg/ml; p < 0.01; 3952.9 ± 1704.75 ng/ml vs. 4507.49 ± 1190.01 ng/ml; p = 0.037, respectively) on days 1 and 2 (12.01 ± 6.31 vs. 13.85 ± 6.01 pg/ml; p = 0.089; 4447.92 ± 1325.31 ng/ml vs. 4637.03 ± 1290.99 ng/ml; p = 0.255, respectively). No differences in IL-6 or hs-CRP were observed after 1 month or 2 years in the clinical control. Levels of TNF-α did not differ between the groups in the early period after BVS or metallic stent implantation, nor during follow-up. The immune-inflammatory response is lower during the early phase after BVS implantation compared to that after metallic stent implantation, but the responses did not differ in the long term.

Mortality prediction after transcatheter treatment of failed bioprosthetic aortic valves utilizing various international scoring systems: Insights from the Valve-in-Valve International Data (VIVID).

BACKGROUND: Transcatheter Aortic Valve Implantation (TAVI) is commonly used to deploy new bioprosthetic valves inside degenerated surgically implanted aortic valves in high risk patients. The three scoring systems used to assess risk of postprocedural mortality are: Logistic EuroSCORE (LES), EuroSCORE II (ES II), and Society of Thoracic Surgeons (STS). OBJECTIVE: The purpose of this study is to analyze the accuracy of LES, ES II, and STS in estimating all-cause mortality after transcatheter aortic valve-in-valve (ViV) implantations, which was not assessed before. METHODS: Using the Valve-in-Valve International Data (VIVID) registry, a total of 1,550 patients from 110 centers were included. The study compared the observed 30-day overall mortality vs. the respective predicted mortalities calculated by risk scores. The accuracy of prediction models was assessed based on calibration and discrimination. RESULTS: Observed mortality at 30 days was 5.3%, while average expected mortalities by LES, ES II and STS were 29.49 (± 17.2), 14.59 (± 8.6), and 9.61 (± 8.51), respectively. All three risk scores overestimated 30-day mortality with ratios of 0.176 (95% CI 0.138-0.214), 0.342 (95% CI 0.264-0.419), and 0.536 (95% CI 0.421-0.651), respectively. 30-day mortality ROC curves demonstrated that ES II had the largest AUC at 0.722, followed by STS at 0.704, and LES at 0.698. CONCLUSIONS: All three scores overestimated mortality at 30 days with ES II showing the highest predictability compared to LES and STS; and therefore, should be recommended for ViV procedures. There is a need for a dedicated scoring system for patients undergoing ViV interventions.

Optical coherence tomography in STEMI with bioresorbable scaffold: possible cause of coronary flow impairment? A sub-study from the Prague 19 trial.

This study assessed the Optical Coherence Tomography (OCT) impact on the coronary flow in ST-elevation myocardial infarction (STEMI) after bioresorbable scaffold implantation. Only few data about OCT use in STEMI are available and coronary flow before and after OCT is not well studied yet. 54 patients with OCT performed at the end of procedure from the Prague 19 trial were selected and coronary flow was evaluated as TIMI frame count (TFC) before and just after OCT. Significant increase in TIMI frame count after OCT [from 9.5 (6.75-12.25) to 11.5 (8-15.25) frames; p = 0.001] and high verapamil administration (18%) was reported. OCT at the end of primary percutaneous coronary intervention with bioresorbable scaffold is a feasible procedure. However, it seems to be associated with flow deterioration.

Neointimal coverage and late apposition of everolimus-eluting bioresorbable scaffolds implanted in the acute phase of myocardial infarction: OCT data from the PRAGUE-19 study.

Incomplete stent apposition and uncovered struts are associated with a higher risk of stent thrombosis. No data exist on the process of neointimal coverage and late apposition status of the bioresorbable vascular scaffold (BVS) when implanted in the highly thrombogenic setting of ST-segment elevation acute myocardial infarction (STEMI). The aim of this study was to assess the serial changes in strut apposition and early neointimal coverage of the BVS using optical coherence tomography (OCT) in selected patients enrolled in the PRAGUE-19 study. Intracoronary OCT was performed in 50 patients at the end of primary percutaneous coronary intervention for acute STEMI. Repeated OCT of the implanted BVS was performed in 10 patients. Scaffold area, scaffold mean diameter and incomplete strut apposition (ISA) were compared between baseline and control OCT. Furthermore, strut neointimal coverage was assessed during the control OCT. Mean scaffold area and diameter did not change between the baseline and control OCT (8.59 vs. 9.06 mm(2); p = 0.129 and 3.31 vs. 3.37 mm; p = 0.202, respectively). Differences were observed in ISA between the baseline and control OCT (0.63 vs. 1.47 %; p < 0.05). We observed 83.1 % covered struts in eight patients in whom the control OCT was performed 4-6 weeks after BVS implantation, and 100 % covered struts in two patients 6 months after BVS implantation. Persistent strut apposition and early neointimal coverage were observed after biodegradable vascular scaffold implantation in patients with acute ST-segment elevation myocardial infarction.

Culprit lesion thrombus burden after manual thrombectomy or percutaneous coronary intervention-alone in ST-segment elevation myocardial infarction: the optical coherence tomography sub-study of the TOTAL (ThrOmbecTomy versus PCI ALone) trial.

AIMS: Manual thrombectomy has been proposed as a strategy to reduce thrombus burden during primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI). However, the effectiveness of manual thrombectomy in reducing thrombus burden is uncertain. In this substudy of the TOTAL (ThrOmbecTomy versus PCI ALone) trial, we compared the thrombus burden at the culprit lesion using optical coherence tomography (OCT) in patients treated with thrombectomy vs. PCI-alone. METHODS AND RESULTS: The TOTAL trial (N = 10 732) was an international, multicentre, randomized trial of thrombectomy (using the Export catheter, Medtronic Cardiovascular, Santa Rosa, CA, USA) in STEMI patients treated with primary PCI. The OCT substudy prospectively enrolled 214 patients from 13 sites in 5 countries. Optical coherence tomography was performed immediately after thrombectomy or PCI-alone and then repeated after stent deployment. Thrombus quantification was performed by an independent core laboratory blinded to treatment assignment. The primary outcome of pre-stent thrombus burden as a percentage of segment analysed was 2.36% (95% CI: 1.73-3.22) in the thrombectomy group and 2.88% (95% CI: 2.12-3.90) in the PCI-alone group (P = 0.373). Absolute pre-stent thrombus volume was not different (2.99 vs. 3.74 mm(3), P = 0.329). Other secondary outcomes of pre-stent quadrants of thrombus, post-stent atherothrombotic burden, and post-stent atherothrombotic volume were not different between groups. CONCLUSION: Manual thrombectomy did not reduce pre-stent thrombus burden at the culprit lesion compared with PCI-alone. Both strategies were associated with low thrombus burden at the lesion site after the initial intervention to restore flow.

Bioresorbable vascular scaffolds in acute ST-segment elevation myocardial infarction: a prospective multicentre study 'Prague 19'.

AIMS: Bioresorbable vascular scaffolds (BVSs) have been studied in chronic coronary artery disease, but not in acute ST-segment elevation myocardial infarction (STEMI). This prospective multicentre study analysed the feasibility and safety of BVS implantation during primary percutaneous coronary intervention (p-PCI) in STEMI. METHODS AND RESULTS: Bioresorbable vascular scaffold implantation became the default strategy for all consecutive STEMI patients between 15 December 2012 and 30 August 2013. A total of 142 patients underwent p-PCI; 41 of them (28.9%) fulfilled the inclusion/exclusion criteria for BVS implantation. The BVS device success was 98%, thrombolysis in myocardial infarction 3 flow was restored in 95% of patients, and acute scaffold recoil was 9.7%. An optical coherence tomography (OCT) substudy (21 patients) demonstrated excellent procedural results with only a 1.1% rate of scaffold strut malapposition. Edge dissections were present in a 38% of patients, but were small and clinically silent. Reference vessel diameter measured by quantitative coronary angiography was significantly lower than that measured by OCT by 0.29 (±0.56) mm, P = 0.028. Clinical outcomes were compared between BVS group and Control group; the latter was formed by patients who had implanted metallic stent and were in Killip Class I or II. Combined clinical endpoint was defined as death, myocardial infarction, or target vessel revascularization. Event-free survival was the same in both groups; 95% for BVS and 93% for Control group, P = 0.674. CONCLUSION: Bioresorbable vascular scaffold implantation in acute STEMI is feasible and safe. The procedural results evaluated by angiography and OCT are excellent. The early clinical results are encouraging.

[Fully absorbable drug eluting coronary stent: where do we stand in 2014?]. / Plne vstrebatelný lékový koronární stent: kde jsme v roce 2014?

Coronary stent is routinely used in majority percutaneous coronary interventions for a long time. They have an important role, especially, in the first months after intervention. We can consider as a breakthrough point the development of stent which has ability to absorb in intervened artery after a few years. The review presents current techniques of fully absorbable coronary stents and also provides clinical trials and experiences available in 2014. The article continues with discussion between supporters and opponents of this new technique, but definitive conclusion can't be done yet. The authors conclude the review with their own opinion. There are many encouraging data in patients with good clinical outcome after implantation of absorbable stents in more than 10 years follow-up.

[The user´s reporting from the national registry of catheter aortic valve implantations (Czech TAVI Registry): the possibilities of the analytical reports based on the database system TrialDB2]. / Uzivatelské výstupy z národního registru katetrových implantací aortální chlopne (Czech TAVI Registry): moznosti analytických výstupu zalozených na databázovém systému TrialDB2.

Assessment of the treatment procedures and their results is increasingly important in current medicine. The emphasis is put on an effective use of the health technologies (HTA). Unlike randomised studies, which involve strictly selected groups of patients who meet inclusion and exclusion criterias, the multicentre clinical registries provide a real-life picture of the treatment safety and effectiveness. Well prepared registries involve both research database and a friendly user interface enabling collection of parametric and easily analyzable data. Although there are some technological aspects aiming to ensure a maximum quality of entered data, cooperation with the users and data managers is essential. Such a registry, otherwise meaningful, must provide answers to previously defined medical hypotheses. Regular feedback to users (so called benchmarking or reporting) is considered to be of key importance. The Czech TAVI Registry (CTR) is a good example of reaching all of the above defined criterias. This registry contains data of approximately 95 % of all transcatheter aortic valve implantations (TAVI) performed in the Czech Republic. It is based on a general system aimed at the design of clinical trials, namely the TrialDB2 (a database system for clinical registries developed by the Institute of Biostatistics and Analyses at the Masaryk University (IBA MU). CTR has been run as an English-language version under the auspices of the Czech Society of Cardiology and represents one of the top-quality registries maintained by IBA MU. This paper presents the currently available database systems and some reports from this particular registry.