Description and prevalence of ventricular mitral annular disjunction: variation of normality or pathological variant?

INTRODUCTION AND OBJECTIVES: The aim of this study was to investigate a new variation of the atrial wall-mitral annulus-ventricular wall junction along the mural mitral leaflet and commissures: the ventricular mitral annular disjunction (v-MAD). This new variant is characterized by spatial displacement of the mitral leaflet hinge line by more than 2 mm toward the left ventricle. METHODS: We examined a cohort of autopsied human hearts (n = 224, 21.9% females, 47.9 ± 17.6 years) from patients without known cardiovascular disease to identify the presence of v-MAD. RESULTS: More than half (57.1%) of the hearts showed no signs of MAD in the mural mitral leaflet or mitral commissures. However, v-MAD was found in 23.6% of cases, located within 20.1% of mural leaflets, 2.2% in superolateral commissures, and 1.3% in inferoseptal commissures. V-MAD was not uniformly distributed along the mitral annulus circumference, with the most frequent site being the P2 scallop (19.6% of hearts). The v-MAD height was significantly greater in mural leaflets than in commissures (4.4 mm ± 1.2 mm vs 2.1 mm ± 0.1 mm; P < .001). No specific variations in mitral valve morphology or anthropometrical features of donors were associated with the presence or distribution of v-MADs. Microscopic examinations revealed the overlap of the thin layer of atrial myocardium over ventricular myocardium in areas of v-MAD. CONCLUSIONS: Our study is the first to present a detailed definition and morphometric description of v-MAD. Further studies should focus on the clinical significance of v-MAD to elucidate whether it represents a benign anatomical variant or a significant clinical anomaly.

The Impact of Age on the Physiological Assessment of Borderline Coronary Stenoses.

Background and Objectives: Coronary angiography is the gold standard for diagnosing coronary artery disease (CAD). In the case of borderline changes, patients require further diagnosis through ischemia assessment via one of the recommended methods of invasive evaluation. This study aimed to assess whether clinical factors influence the risk of a positive result in invasive myocardial ischemia assessment and if these potential factors change with the patient's age and the consistency of ischemia assessment. Materials and Methods: Data were collected retrospectively on all consecutive patients hospitalized in the University Hospital in Krakow between 2020 and 2021, on whom physiological assessments of coronary circulation were performed. Patients were divided into two groups: patients aged 60 or younger and patients older than 60. Results: Despite the older patients having more risk factors for CAD, their physiological assessment results of borderline lesions were similar to those of the younger patients. Positive fractional flow reserve (FFR) assessments were obtained from almost 50% of vessels. In the younger patients, cigarette use and type 2 diabetes mellitus increased the risk of a positive FFR result by 3.5 and 2.5 times, respectively. In the older patients, male gender and peripheral vascular disease significantly increased the risk of a positive FFR by 2.5 and 2 times, respectively. Conclusions: Clinical characteristics of patients undergoing physiological assessment of borderline coronary stenosis varied significantly by age. Refining the definition of borderline lesions to include age, gender, and other factors may improve the identification of patients who would benefit from physiological assessment and coronary revascularization.

Corrected QT interval in electrocardiogram recordings in patients treated with calcium channel blockers.

Introduction: One of the most popular tests of the heart is the electrocardiogram (ECG). The physical basis of this study has been known for over 200 years. However, the way an ECG is performed and the interpretation of the obtained results have undergone considerable evolution over time. Aim: To analyze the ECG recordings regarding the QTc interval in patients taking calcium channel blockers. Material and methods: The publicly available PhysioNet signals database was used to analyze the effect of selected drugs on the heart rhythm and QTc interval. To automate the QTc assessment, the database was processed in MATLAB. First, QTc was assessed using four formulas; then the results were compared in terms of methodology and medications taken. Results: In the group of patients taking dihydropyridine blockers, the QTc interval assessed by the Bazett formula (mean: 478.87 ms; SD: 73.10) is longer than in patients taking non-dihydropyridine blockers (mean: 446.54 ms, SD: 88.07, p = 0.2123) and in patients not taking calcium channel blockers (mean: 436.33 ms, SD: 49.94, p = 0.0319). The same significant differences were obtained regardless of the QTc assessment method used. However, the QTc result obtained with the Bazett formula is significantly lower than in the case of using the other three formulas used for the presented analysis. Conclusions: Automatic ECG analysis is possible; however, it should be used carefully, considering the possibility of obtaining incorrect results. Taking calcium channel blockers may affect the QTc interval. QTc results significantly depend on the formula based on which we evaluate this parameter.

Influence of sex on the functional assessment of myocardial ischemia.

BACKGROUND: Fractional flow reserve (FFR) and non-hyperemic resting pressure ratios, such as instantaneous wave-free ratio (iFR) and resting full-cycle ratio (RFR), are recommended for evaluating the significance of angiographically intermediate coronary stenoses. Despite their usefulness, approximately 20% of assessed lesions exhibit discordance between FFR and iFR/RFR. AIMS: The role of sex in this discrepancy remains uncertain; thus, we aimed to investigate its impact on the discordance between FFR and iFR/RFR. METHODS: We reviewed 417 consecutive intermediate stenotic lesions from 381 patients, stratified by sex and assessed with both FFR and iFR/RFR. FFR ≤0.80 and iFR/RFR ≤0.89 were considered positive for ischemia. RESULTS: Of the 381 patients, 92 (24.1%) were women. Women were older, had a lower estimated glomerular filtration rate (eGFR), higher ejection fraction, and were more likely to have peripheral artery disease than men. Median FFR and iFR/RFR values were lower in men than in women (FFR 0.86 vs. 0.80; P <0.001; iFR 0.92 vs. 0.90; P = 0.049). However, overall discordance prevalence was similar for both sexes (20.6% vs. 15.1%; P = 0.22). In men, eGFR, insulin-treated diabetes mellitus, and arterial hypertension were predictors of positive FFR | negative iFR/RFR discordance, while eGFR, insulin-treated diabetes mellitus, atrial fibrillation, and chronic obstructive pulmonary disease were predictors of negative FFR | positive iFR/RFR discordance. No factors associated with either discordance were identified in women. CONCLUSIONS: FFR and iFR/RFR results indicating significant ischemia were more common in men than women when assessing intermediate coronary stenoses. Nevertheless, sex did not predict discordant results.

Influence of diabetes mellitus on the invasive assessment of myocardial ischemia in patients with coronary artery disease.

INTRODUCTION: Current guidelines recommend physiological evaluation of borderline coronary artery stenoses using hyperemic (fractional flow reserve [FFR]) and nonhyperemic (instantaneous wave­free ratio [iFR] and resting full­cycle ratio [RFR]) methods. However, comorbidities, such as diabetes mellitus (DM), may influence the results of the assessment. OBJECTIVES: We sought to investigate the impact of DM and insulin treatment on the discordance between FFR and iFR/RFR. PATIENTS AND METHODS: A total of 417 intermediate stenoses in 381 patients underwent FFR and iFR/RFR assessment. FFR lower than or equal to 0.8 and iFR/RFR lower than or equal to 0.89 indicated significant ischemia. The patients were categorized based on DM diagnosis and insulin treatment status. RESULTS: Of the 381 patients, 154 (40.4%) had DM. Among these, 58 patients (37.7%) received insulin treatment. Diabetic patients had higher body mass index and glycated hemoglobin levels, and lower ejection fraction. FFR and iFR/RFR analyses were conducted in 417 vessels with available measurements for both tests. A good correlation between FFR and iFR/RFR was confirmed in both diabetic (R = 0.77) and nondiabetic (R = 0.74) patients. Discordance between FFR and iFR/RFR occurred in approximately 20% of cases, and the frequency of discordance was not affected by the diabetic status. However, insulin­treated DM was independently associated with a higher risk of negative FFR and positive iFR/RFR discordance (odds ratio, 4.61; 95% CI, 1.38-15.4; P = 0.01). Also, the optimal cutoff value for FFR identifying significant ischemia in DM patients treated with insulin was higher (0.84) than the generally recommended value. CONCLUSIONS: The rate of FFR and iFR/FFR discordance was similar regardless of the diabetes status, and insulin­treated DM was associated with an increased risk of negative FFR and positive iFR/RFR discordance.

Thrombus containing lesions strategies during primary percutaneous coronary interventions in ST-segment elevation myocardial infarction: insights from ORPKI National Registry.

In the era of potent P2Y12 inhibitors, according to current guidelines, treatment with glycoprotein IIb/IIIa inhibitors (GPIs) should be limited to bail-out and/or highly thrombotic situations. Similarly, the recommendation for aspiration thrombectomy (AT) is downgraded to very selective use. We examine the prevalence, and predictors of GPI and AT use in STEMI patients referred to primary percutaneous coronary intervention (PCI). Data on 116,873 consecutive STEMI patients referred to primary PCI in Poland between 2015 and 2020 were analyzed. GPIs were administered in 29.3%, AT was used in 11.6%, and combined treatment with both in 6.1%. There was a mild trend toward a decrease in GPI and AT usage during the analyzed years. On the contrary, there was a rapid growth of the ticagrelor/prasugrel usage rate from 6.5 to 48.1%. Occluded infarct-related artery at baseline and no-reflow during PCI were the strongest predictors of GPI administration (OR 2.3; 95% CI 2.22-2.38 and OR 3.47; 95% CI 3.13-3.84, respectively) and combined usage of GPI and AT (OR 4.4; 95% CI 4.08-4.8 and OR 3.49; 95% CI 3.08-3.95 respectively) in a multivariate logistic regression model. Similarly, the administration of ticagrelor/prasugrel was an independent predictor of both adjunctive treatment strategies. In STEMI patients in Poland, GPIs are selectively used in one in four patients during primary PCI, and the combined usage of GPI and AT is marginal. Despite the rapid growth in potent P2Y12 inhibitors usage in recent years, GPIs are selectively used at a stable rate during PCI in highly thrombotic lesions.

Comparison of Fractional Flow Reserve with Resting Non-Hyperemic Indices in Patients with Coronary Artery Disease.

Guidelines recommend using hyperemic (FFR) and non-hyperemic (iFR/RFR) methods of evaluating coronary artery stenoses in patients with coronary artery disease. However, in some cases, achieved results indicating significant ischemia may differ between those methods. Thus, we sought to identify predictors of such a discrepancy. Data were collected on all consecutive patients with chronic coronary syndrome hospitalized between 2020 and 2021. For 279 patients (417 vessels), results for both FFR and iFR/RFR were available. Values of ≤0.80 for FFR and ≤0.89 for iFR/RFR were considered positive for ischemia. Discordant measurements of FFR and iFR/RFR were observed in 80 (19.2%) patients. Atrial fibrillation was the only predictor of the overall FFR and iFR/RFR discordance - OR (95%CI) 1.90 (1.02-3.51); p = 0.040. The chance of positive FFR and negative iFR/RFR decreased independently with age - OR (95%CI) 0.96 (0.93-0.99); p = 0.024. On the contrary, insulin-treated diabetes mellitus was the predictor of negative FFR and positive iFR/RFR discrepancy - OR (95%CI) 4.61 (1.38-15.40); p = 0.013. In everyday clinical practice, iFR/FFR correlates well with FFR. However, discordance between these methods is quite common. Physicians should be aware of the risk of such discordance in patients with atrial fibrillation, advanced age, and insulin-treated diabetes mellitus.

Diabetes Mellitus Is Still a Strong Predictor of Periprocedural Outcomes of Primary Percutaneous Coronary Interventions in Patients Presenting with ST-Segment Elevation Myocardial Infarction (from the ORPKI Polish National Registry).

The impact of diabetes mellitus (DM) on outcomes of patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) was confirmed by several studies. However, it is unclear whether this effect is still present in large groups of unselected patients undergoing up-to-date treatment. Thus, we sought to assess the impact of DM on periprocedural outcomes of primary PCI in STEMI using data from the Polish National Registry of PCI. Data on 150,782 STEMI patients undergoing primary PCI were collected. Of them, 26,360 (17.5%) patients had DM. Patients with DM were higher-risk individuals who experienced longer reperfusion delays and were less likely to have closed infarct-related artery at baseline (TIMI 0 + 1 flow: 73.2% vs. 72.0%; p < 0.0001) and achieve optimal reperfusion after PCI (TIMI 3 flow: 91.8% vs. 88.5%; p < 0.0001). The periprocedural mortality (1.1% vs. 1.9%; p < 0.0001) was higher in patients with DM and DM was identified as an independent predictor of periprocedural death. In conclusion, despite continuous progress in STEMI treatment, DM remains a strong predictor of periprocedural mortality. However, this detrimental effect of DM may be partially explained by the overall higher risk profile of diabetic patients.

Dissections after bioresorbable vascular scaffold implantation in the POLAR ACS Registry.

Introduction: Percutaneous coronary intervention (PCI) is a common method of treatment for patients with coronary artery disease. One of the most common complications during the PCI procedure is coronary artery dissection. It usually requires an additional action to assure the patency of the treated vessel. Aim: The aim of the publication is to describe the occurrence of coronary artery dissection after bioresorbable vascular scaffold (BVS) implantation. This selected type of PCI procedure is especially interesting because precise target vessel measurement before BVS implantation is required for optimal determination of scaffold size. Material and methods: Based on angiographic data gathered in the POLAR ACS Registry, we assessed the frequency of dissections, their localization, and severity. Based on data regarding patients' demographic, clinical status, and details regarding treatment strategy, the factors that could have an influence on the dissection occurrence were identified. Results: A group of 100 patients included in the analyses. Group A consisted of 9 patients. This group was defined as patients in whom the significant dissection occurred after the BVS implantation. Group B comprised 91 patients. Both groups were very similar according to demographic data. The frequency of predilatation was similar; post-dilatation was performed more often in group A but without statistical significance. The presence of calcification in the target lesion was an independent factor of dissection during the index PCI procedure. Conclusions: The occurrence of significant dissection can be effectively treated, and the good angiographic results of this treatment immediately after the initial procedure translate into good clinical results in longer follow-up.

Comparison of FFR, iFR, and QFR assessment in patients with severe aortic stenosis and coronary heart disease.

Introduction: Some patients with coronary heart disease are diagnosed with severe aortic stenosis. For further treatment, coronary angiography is performed in these patients. For intermediate lesions, obtaining coronary artery physiological data can facilitate clinical decision-making regarding revascularization. Aim: The study compared the physiological significance of coronary artery stenosis using the fractional flow reserve (FFR) method with instantaneous wave-free pressure ratio (iFR) and quantitative flow ratio (QFR) in patients qualified for aortic valve replacement. Material and methods: Data were collected on patients hospitalized in the years 2019-2020 at the 2nd Department of Cardiology, University Hospital in Krakow. Results: Twelve patients with severe aortic stenosis and borderline lesions in the coronary artery were qualified for physiological assessment. There were 6 women, whose mean age was 73.8 ±7.5 years. The mean left ventricular ejection fraction was 52 ±15%. The mean aortic valve area was 0.80 ±0.16 cm2. The left anterior descending artery was assessed in 12 from 13 cases (92%). In comparison to FFR, all iFR measurements were concordant with FFR. The total agreement between QFR and FFR/iFR assessment was 69%. Conclusions: Despite the controversy and uncertainty of some operators regarding the interpretation of the FFR test in patients with severe aortic stenosis, we obtained complete agreement of FFR with iFR assessment. This fact suggests that in patients with severe aortic stenosis the choice of an invasive method to assess the physiological significance of the stenosis in the coronary artery is not crucial - both iFR and FFR allow comparable results.

Risk factors of contrast-induced nephropathy in patients with acute coronary syndrome.

BACKGROUND: Patients with acute coronary syndrome (ACS) are at high risk of contrast-induced nephropathy (CIN), which is associated with prolonged hospitalization, higher morbidity and mortality after angiographic procedures. The occurrence of CIN is regarded as a transient and reversible condition. However, the persistence of CIN until hospital discharge in patients with ACS has not been thoroughly analyzed. AIMS: We aimed to analyze CIN persistent until hospital discharge in contemporary ACS population referred to invasive diagnostics and treatment. METHODS: A total of 2638 consecutive patients with ACS were included in a prospective registry. The occurrence of CIN was defined as a 25% increase in serum creatinine from baseline or a 0.5 mg/dl (44 µmol/l) increase in the absolute value. RESULTS: Criteria of CIN at hospital discharge were met in 10.7% of patients. Immediate percutaneous coronary intervention (PCI) after angiography (67% of patients) was associated with higher rates of CIN compared to patients referred for other treatment strategies (P < 0.001). The logistic regression model showed that anemia at baseline (8.7% of patients) was an independent predictor of CIN, which occurred in 17.9% of anemic patients and 10% of patients without anemia (P < 0.001). Also, ST-segment elevation myocardial infarction (STEMI) presentation and immediate PCI were independent predictors of CIN. CONCLUSIONS: Despite intravenous fluid administration during the hospital stay, CIN persisted until hospital discharge in more than 10% of patients with ACS. Anemia at baseline, STEMI presentation, and immediate PCI strategy were independent predictors of CIN. Thus, preventive actions should be specially aimed at those groups of patients.

Eligible-and-enrolled vs. eligible-but-not-enrolled patients with chronic ischaemic heart failure in randomized clinical trials of myocardial regeneration.

Introduction: Clinical trial applicability to routine clinical practice is a fundamental consideration. Little is known about factors that determine enrolment (vs. non-enrolment) in chronic ischaemic heart failure (CIHF) interventional randomized controlled trials (iRCT). Aim: To compare clinical characteristics and medical therapy in eligible-and-enrolled (E-E) vs. eligible-but-not-enrolled (E-NE) patients in CIHF myocardial regeneration iRCTs. Material and methods: Clinical characteristics and medical treatment were compared for E-E and E-NE in 4 periods (32 months): P1 (iRCT#1 recruitment), P2 (between iRCT#1 and iRCT#2), P3 (iRCT#2 recruitment), P4 (post iRCT#2). iRCT#1 and iRCT#2 shared inclusion/exclusion criteria. Results: Evaluation involved 5,436 hospitalized patients (P1-P4; CIHF-526). 283 were iRCT eligible (53.8%). The eligibility rate was similar throughout P1-P4 (43.1-58.5%, p = 0.08). Eligible patient characteristics and pharmacotherapy did not differ in recruitment vs. non-recruitment periods. Principal reasons for ineligibility were recent/planned cardiac intervention outside iRCT (22.8%), age above threshold (14.6%) and coexisting disease as the exclusion criterion (12.2%). Primary reasons for eligible patient non-enrolment (n = 89) were other trial participation (52.8%) and no consent (28.1%). E-E patients did not differ from E-NE in characteristics including CIHF medical management and clinical stage; the exception was more severe left ventricular impairment in E-E (LVEF 31.2 vs. 33.9%, p = 0.039; end-diastolic volume 197.8 vs. 160.4 ml, p < 0.0001). Conclusions: CIHF medical management was similar in E-E and E-NE. Ineligibility resulted mainly from recent/planned intervention outside iRCT and age > 80 years. LV impairment was more severe in E-E patients, consistent with higher-risk patient enrolment in CIHF-iRCTs. This contrasts with typical lower-risk patient enrolment in other cardiovascular RCT types and populations.

Over-the-counter antipyretics use among children from Southeastern Poland.

BACKGROUND: Over-the-counter (OTC) drugs are becoming increasingly popular. However, little is known about parents' practices concerning the use of OTC antipyretics in children. This paper aimed to study the habits and knowledge of parents regarding the use of OTC antipyretics in their offspring, considering the demographic and socioeconomic characteristics of the families. MATERIAL AND METHODS: A multiple-purpose survey was conducted anonymously among 229 parents of patients hospitalised in the Department of Paediatrics, University Children's Hospital, Krakow. Each parent answered 23 questions regarding OTC antipyretics use in his/her hospitalised child throughout the whole child's life. The data was statistically analysed. RESULTS: OTC antipyretics are administered to their children by 92% of parents. In the vast majority (87%), health care professionals or a leaflet were the sources of information on the drug and its dosage. Parents also used information from TV or the Internet (27%) and friends and family (30%), especially those in the younger age group. Families with high socioeconomic status were more likely to use health care professionals' advice for drug knowledge. Parents of children with allergic diseases made less use of nonmedical sources of knowledge. CONCLUSIONS: The majority of parents use OTC antipyretic drugs in their children. However, a high percentage of people using nonmedical sources of information is of concern. It is necessary to educate caregivers and to build the parents' awareness that they take an active role in their child's treatment. It would be useful to create generally available recommendations for home treatment.

Acute myocardial infarction in young patients.

BACKGROUND: Acute myocardial infarction (AMI) is an incredibly destructive disease when it occurs in a young patient. Thus, the investigation of the disease presentation and treatment options seem to be particularly important in young patients with AMI. AIMS: The study objective was to investigate the differences between young and older patients diag-nosed with AMI in terms of clinical characteristics and treatment strategies. METHODS: The patient data comes from the National Registry of Procedures of Invasive Cardiology (ORPKI). Between 2014 and 2017, data of more than 230 000 patients with a diagnosis of AMI were collected in that registry. Young patients were defined as under 40 years old. RESULTS: Young patients with AMI (n = 3208, 1.3%) compared with older patients with AMI were more often men (86.3% vs. 65.8%; P <0.001) with higher body weight (mean 85.9 vs. 79.7 kg; P <0.001). Typical risk factors of coronary heart disease were less frequent in younger patients than in older patients. However, in the under-40 group, there was a significantly higher number of current smokers (37.5% vs. 23.0%; P <0.001). Young patients with AMI were more often diagnosed with ST-segment elevation myocardial infarction (STEMI; 62.0% vs. 50.0%; P <0.001). Moreover, they had more frequently non-significant ste-nosis in coronary arteries diagnosed (14.4% vs. 6.8%; P <0.001). The left anterior descending artery was more frequently an infarct-related artery in young patients (51.3% vs. 36.3%; P <0.001). Bioresorbable vascular scaffolds were more commonly implanted in young patients with AMI than in the older ones (5.6% vs. 0.9%; P <0.001). The relative number of AMI in the young patients increased from 1.20% in 2014 to 1.43% in 2017. CONCLUSIONS: Smoking is the most common risk factor in young adults. The relative number of AMI in young patients is growing.

Serum cytokine profile as a potential prognostic tool in colorectal cancer patients - one center study.

AIM: Comparison of 14 cytokines levels between a control group and prospectively enrolled CRC patients to confirm their significance in CRC development. We tested if a model based on 14 cytokines levels could predict prognosis in Caucasian CRC patients treated with 5-FU based chemotherapy. BACKGROUND: Novel prognostic tools in colorectal cancer (CRC) are necessary to optimize treatment, reduce toxicity and chemotherapy (CHT) costs. MATERIALS AND METHODS: We assessed prognostic significance of 14 cytokines: IL-1 beta, IL-1RA, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL12p70, IL-13, IL-17A in 75 prospectively enrolled CRC patients before initiation of palliative or adjuvant CHT and in 22 control subjects. Readings were taken using the Bio-Plex 200 System. Response to treatment was assessed after 6 months from initiation of CHT. The treated group was divided depending on the response into a progressors (death, progression of disease) and non-progressors group (stable disease, partial response, complete response). RESULTS: We found that increased concentration of IL-8 was a negative prognostic factor in the whole group and palliative subgroup, whereas increased level of IL-10, IL-7, and IL-12p70 was a negative predictor in the adjuvant group CHT. CONCLUSIONS: We proposed a statistical model based on circulating cytokine levels, showing a good prognostic value in prediction of the response to CHT (AUC = 0.956). The model, including combined IL-2, IL-8, IL-10 and IL-13 levels, established in the whole treated group, should be validated in larger trials.

Prospective multicentre study of carotid artery stenting using the MER™ Stent - the OCEANUS study - 30-day and one-year follow-up results.

INTRODUCTION: Constant technological progress in the field of carotid stenting translates into improved short- and long-term results of endovascular treatment. The introduction of a new generation, self-expanding, open-cell stent has provided a new treatment option in endovascular management of carotid stenosis. AIM: To evaluate 30-day and 1-year clinical outcomes of non-consecutive patients with high risk of carotid endarterectomy, who underwent 5F cylinder-tapered MER™ open-cell carotid stent implantation. MATERIAL AND METHODS: It was a single-arm, prospective study conducted in four experienced catheterisation centres. The use of embolic protection devices was mandatory. The primary endpoint was stroke in 30-day follow-up. The secondary endpoints were 30-day and 1-year cumulative incidence of death, stroke and myocardial infarction, 1-year target vessel revascularisation, procedural success (residual stenosis ≤ 30%), restenosis rate (%DS ≥ 50%), and Serious Adverse Device Effect (SADE) rate in 1-year follow-up. RESULTS: In total 100 patients were recruited for the study, with the majority being males (n = 61). The mean age was 68.3 ±8.2 years, and most of the patients were asymptomatic (n = 56). In 55 (55%) patients direct stenting was performed, with the use of proximal protection devices in 19 (19%) patients. Mean internal carotid artery/common carotid artery stenosis before and after stent implantation was 81.98 ±9.15% and 12.52 ±8.70%, respectively (p < 0.001). Procedural success was achieved in all cases. One ischaemic stroke was observed at 30 days (1%, primary endpoint). At 1-year follow-up two myocardial infarctions and three deaths occurred with no additional stroke. CONCLUSIONS: The OCEANUS study indicated the safety and efficacy of the MER™ stent during 30-day and 1-year follow-up in both symptomatic and asymptomatic patients. The majority of patients were event-free. However, larger cohort studies are needed to evaluate MER™ stents in detail.