Learning Curve for Starting a Successful Single-Centre TAVR Programme with Multiple Devices: Early and Mid-Term Follow-Up.

Aims: We report 30-day, 1-year, and 3-year outcomes for a new TAVR programme that used five different transcatheter heart valve (THV) systems. Methods: From 2014 to 2020, 122 consecutive patients with severe aortic stenosis (AS) received TAVR based on the Heart Team decision. Outcomes were analysed for the whole study population and in addition the first 63 patients (Cohort A, 2014 to 2019) were compared to the last 59 patients (Cohort B, 2019 to 2020). Outcomes included VARC-2 definitions and device performance assessed via transthoracic echocardiography by independent high-volume investigators. Results: The mean patient age was 77.9 ± 6.1 years old, and 48 (39.3%) were male. The mean logistic Euroscore II was 4.2 ± 4.5, and the mean STS score was 6.9 ± 4.68. The systems used were as follows: Medtronic Corevalve Evolute R/PRO (82 patients-67.2%); Abbott Portico (13-10.6%); Boston Scientific Lotus (10-8.2%); Meril Myval (11-9%); and Boston Scientific Neo Accurate (6-5%). Access was transfemoral (95.9% of patients); surgical cut down (18% vs. percutaneous 77.8%); subclavian (n = 2); trans-axillary (n = 2); and direct aorta (n = 1). VARC-2 outcomes were as follows: device success rate 97.5%; stroke rate 1.6%; major vascular complication 3.3%; permanent pacemaker implantation 12.4%. At discharge, the incidences of grade I and II aortic regurgitation were 39.95 and 55.5%, respectively. At one year, all-cause mortality was 7.4% without admissions for valve-related dysfunction. The 3-year all-cause mortality and all-stroke rates were 22.9% and 4.1%, respectively. Between the 1-year and 3-year follow-ups, valve-related dysfunction was detected in three patients; one had THV system endocarditis that led to death. There was a remarkable but statistically non-significant decrease in mortality from Cohort A to Cohort B [four (6.3%) vs. one patient (1.7%), p = 0.195] and major vascular complications occurred at a significantly higher rate in the Cohort B [zero (0%) vs. four (6.8% patient, p = 0.036)]. Overall, we found that using multiple devices was safe and allowed for a learning team to achieve a high device success rate from the beginning (97.5%). Conclusions: TAVR with different THV systems showed acceptable early and mid-term outcomes for survival, technical success, and valve-related adverse events in high-risk patients with significant AS, even in the learning curve phase.

Single-Center Experience with the Balloon-Expandable Myval Transcatheter Aortic Valve System in Patients with Bicuspid Anatomy: Procedural and 30-Day Follow-Up.

Aims: To report our single-center data regarding the initial 52 consecutive patients with a bicuspid aortic valve who underwent a Transcatheter Aortic Valve Implantation (TAVI) procedure using the new balloon-expandable MYVAL system. The focus is on reporting procedural details and outcomes over the 30-day postoperative period. Methods: From December 2019 to July 2023, 52 consecutive patients underwent a TAVI procedure with bicuspid anatomy. All patients had moderate to-high surgical risk or were unsuitable for surgical aortic valve replacement based on the Heart Team's decision. Outcomes were analyzed according to the VARC-2 criteria. The results of bicuspid patients were compared to patients with tricuspid anatomy in the overall study group, and further analysis involved a comparison between 52 pairs after propensity score matching. The device performance was evaluated using transthoracic echocardiography. Data collection was allowed by the Local Ethical Committee. Results: The mean age was 71 ± 7.1 years, and 65.4% were male. The mean Euroscore II and STS score were 3.3 ± 3.2 and 5.2 ± 3.3, respectively. Baseline characteristics and echocardiographic parameters were well balanced even in the unmatched comparison. Procedures were significantly longer in the bicuspid group and resulted in a significantly higher ARI index. All relevant anatomic dimensions based on the CT scans were significantly higher in bicuspid anatomy, including a higher implantation angulation, a higher rate of horizontal aorta and a higher proportion of patients with aortopathy. In the unmatched bicuspid vs. tricuspid comparison, postprocedural outcomes were as follows: in-hospital mortality 0% vs. 1.4% (p = 0.394), device success 100% vs. 99.1% (p = 0.487), TIA 1.9% vs. 0% (p = 0.041), stroke 1.9% vs. 0.9% (p = 0.537), major vascular complication 3.8% vs. 2.3% (p = 0.530), permanent pacemaker implantation 34% vs. 30.4% (p = 0.429), and cardiac tamponade 0% vs. 0.5% (p = 0.624). In the propensity-matched bicuspid vs. tricuspid comparison, postprocedural outcomes were as follows: in-hospital mortality 0% vs. 0%, device success 100% vs. 100%, TIA 1.9% vs. 0% (p = 0.315), stroke 1.9% vs. 0.9% (p = 0.315), major vascular complication 3.8% vs. 0% (p = 0.475), permanent pacemaker implantation 34% vs. 24% (p = 0.274), and cardiac tamponade 0% vs. 0%. There was no annular rupture nor need for second valve or severe aortic regurgitation in both the unmatched and matched comparison. The peak and mean aortic gradients did not differ at discharge and at 30-day follow-up between the two groups regardless of whether the comparison was unmatched or matched. There were no paravalvular leakages (moderate or above) in the bicuspid patients. Intermediate and extra sizes of the Myval THV system used a significantly higher proportion in bicuspid anatomy with a significantly higher oversize percentage in tricuspid anatomy. Conclusions: The TAVI procedure using the Myval THV system in patients with significant aortic stenosis and bicuspid aortic valve anatomy is safe and effective. Hemodynamic parameters do not differ between tricuspid and bicuspid patients. However, the permanent pacemaker implantation rate is higher than expected; its relevance on long-term survival is controversial.

Topological Dimensions from Disorder and Quantum Mechanics?

We have recently shown that the critical Anderson electron in D=3 dimensions effectively occupies a spatial region of the infrared (IR) scaling dimension dIR≈8/3. Here, we inquire about the dimensional substructure involved. We partition space into regions of equal quantum occurrence probabilities, such that the points comprising a region are of similar relevance, and calculate the IR scaling dimension d of each. This allows us to infer the probability density p(d) for dimension d to be accessed by the electron. We find that p(d) has a strong peak at d very close to two. In fact, our data suggest that p(d) is non-zero on the interval [dmin,dmax]≈[4/3,8/3] and may develop a discrete part (δ-function) at d=2 in the infinite-volume limit. The latter invokes the possibility that a combination of quantum mechanics and pure disorder can lead to the emergence of integer (topological) dimensions. Although dIR is based on effective counting, of which p(d) has no a priori knowledge, dIR≥dmax is an exact feature of the ensuing formalism. A possible connection of our results to the recent findings of dIR≈2 in Dirac near-zero modes of thermal quantum chromodynamics is emphasized.

Single center experience with the balloon-expandable Myval transcatheter aortic valve system with the first 100 patients: 30-day and 1-year follow-up.

AIMS: To report our single-center data, regarding the first 100 patients who underwent TAVR procedure with the new balloon-expandable MYVAL system. We report 30-day and 1-year outcomes in low to high-risk TAVR patient population. METHODS: From November 2019 to July 2021, 100 consecutive patients underwent TAVR procedure. Patient outcome was classified according to the VARC-2 definitions. The device performance was assessed using transthoracic echocardiography. Data collection was allowed by the Local Ethical Committee. RESULTS: The mean age was 74.7 years, 63 (63%) were male. The mean Euroscore II and STS score were 4.8 ± 4.9 and 5.6 ± 3.9, respectively. Transfemoral access was the most frequent (surgical vs. percutaneous 2% vs. 97%) and in one patient surgical subclavian access was used. VARC-2 outcomes were as follows: device success 99%, STROKE 1%, major and minor vascular complication was 1% and 11%, respectively, the rate of new permanent pacemaker implantation was 30.7%. At discharge, the incidence of grade I, grade II aortic regurgitation was 39% and 1%, respectively, without relevant PVL. In-hospital mortality was only 1%. These results included a high proportion (17%) of patients with bicuspid aortic valves. At 1 year, the all-cause mortality rate was 7% (only two due to cardiac event) and only a single patient had valve-related dysfunction requiring surgical aortic replacement. CONCLUSIONS: TAVR procedure with MYVAL transcatheter heart valve system shows excellent 30-day and 1-year outcomes regarding patient survival, technical success, and valve-related adverse events. The limitations of our study comprise a single-center study with retrospective data collection.

Inequalities in premature mortality from ischaemic heart disease in the WHO European region.

OBJECTIVES: Ischaemic heart disease (IHD) is one of the leading causes of premature mortality. Our aim was to analyse standardised premature mortality rates from IHD by geographical groups in the age group 45-59 years. METHODS: We performed a retrospective, quantitative analysis of age-standardized mortality rates from IHD between 1990-2014 per 100,000 population in Western European (WE: N = 17), Eastern European countries (EE: N = 10), and countries of the former Soviet Union (fSU: N = 15) within the European Region of the World Health Organisation (WHO) based on data retrieved from the WHO European Mortality Database. Descriptive statistics, time series analysis and statistical tests were used for the analyses (ANOVA, Kruskal-Wallis test, Mann-Whitney test, paired t-test). RESULTS: On average, age-standardized death rates (ASDR) from IHD per 100,000 population were the lowest in WE (men 1990: 143.67, 2014: 50.29; women 1990: 29.06, 2014: 9.89), and the highest in fSU (men 1990: 358.69, 2014: 253.25; women 1990: 99.78, 2014: 57.85). Between 1990 and 2014, all three groups experienced significant decrease in ASDR both in men and women (fSU: -29.39%, -42.02%; EE: -49.41%, -50.57%; WE: -64.99%, -65.97%, respectively) (p < 0.05). Between 1990 and 2004, ASDR decreased in WE in both sexes (p < 0.001), in EE among males (p = 0.032). Between 2004 and 2014, ASDR from IHD decreased significantly in both sexes in fSU and WE, in EE only among women (p < 0.05). CONCLUSIONS: During the whole period analysed, ischaemic heart disease mortality significantly decreased in both sexes in all the groups.

Optimal Renal Artery-Aorta Angulation Revealed by Flow Simulation.

INTRODUCTION: In the circulatory system, the vessel branching angle may have hemodynamic consequences. We hypothesized that there is a hemodynamically optimal range for the renal artery's branching angle. METHODS: Data on the posttransplant kinetics of estimated glomerular filtration rate (eGFR) were analyzed according to the donor and implant sides (right-to-right and left-to-right position; n = 46). The renal artery branching angle from the aorta of a randomly selected population was measured using an X-ray angiogram (n = 44). Computational fluid dynamics simulation was used to elucidate the hemodynamic effects of angulation. RESULTS AND DISCUSSION: Renal transplant patients receiving a right donor kidney to the right side showed faster adaptation and higher eGFR values than those receiving a left donor kidney to the right side (eGFR: 65 ± 7 vs. 56 ± 6 mL/min/1.73 m2; p < 0.01). The average branching angle on the left side was 78° and that on the right side was 66°. Simulation results showed that the pressure, volume flow, and velocity were relatively constant between 58° and 88°, indicating that this range is optimal for the kidneys. The turbulent kinetic energy does not change significantly between 58° and 78°. CONCLUSION: The results suggest that there is an optimal range for the renal artery's branching angle from the aorta where hemodynamic vulnerability caused by the degree of angulation is the lowest, which should be considered during kidney transplantations.

Counting-Based Effective Dimension and Discrete Regularizations.

Fractal-like structures of varying complexity are common in nature, and measure-based dimensions (Minkowski, Hausdorff) supply their basic geometric characterization. However, at the level of fundamental dynamics, which is quantum, structure does not enter via geometric features of fixed sets but is encoded in probability distributions on associated spaces. The question then arises whether a robust notion of the fractal measure-based dimension exists for structures represented in this way. Starting from effective number theory, we construct all counting-based schemes to select effective supports on collections of objects with probabilities and associate the effective counting dimension (ECD) with each. We then show that the ECD is scheme-independent and, thus, a well-defined measure-based dimension whose meaning is analogous to the Minkowski dimension of fixed sets. In physics language, ECD characterizes probabilistic descriptions arising in a theory or model via discrete "regularization". For example, our analysis makes recent surprising results on effective spatial dimensions in quantum chromodynamics and Anderson models well founded. We discuss how to assess the reliability of regularization removals in practice and perform such analysis in the context of 3d Anderson criticality.

Safety and Efficacy of Single Incision Sling Versus Midurethral Sling in the Treatment of Stress Urinary Incontinence: A Randomized Controlled Trial.

IMPORTANCE: This study compares the long-term efficacy and safety of an innovative single-incision sling (SIS) with the inside-out transobturator tape (TOT) sling in the treatment of female stress urinary incontinence. OBJECTIVES: Women with urodynamic stress urinary incontinence were randomized to either SIS or TOT groups and followed up for 4 years. The primary outcome was objective cure defined with a negative cough stress test result. Secondary outcomes involved subjective cure reported via patient's satisfaction scale, surgery complications, postoperative de novo urgency, and patient's life quality. STUDY DESIGN: This is a randomized noninferiority controlled trial. RESULTS: A total of 168 women were randomized (84 in both groups). After 4-year follow-up, 130 patients were analyzed (66 in the SIS group and 64 in the TOT group). The objective (86.4% vs 84.4%; risk difference [95% confidence interval], 0.020 [-0.101 to 0.141]; P = 0.807) and subjective cure rates (83.3% vs 81.3%; risk difference [95% confidence interval], 0.020 [-0.111 to 0.151]; P = 0.821) were similar with the SIS and TOT groups. Both procedures were associated with low complication rates. Repeated surgery rates were 7.6% in the SIS group and 6.3% in the TOT groups. The mesh exposure rate was 1.5% for the SIS group and 3.1% for the TOT group. Incidence of de novo urgency did not vary between TOT and SIS patients. Both groups registered significant life quality improvement. CONCLUSION: After long-term follow-up, anti-incontinence SIS surgery proved noninferior to the inside-out TOT procedure in terms of objective and subjective cure rates.

Evaluating sexual function among women after recurrent pelvic organ prolapse transvaginal mesh repair.

We aimed to evaluate women's sexual function before and after pelvic organ prolapse (POP) surgery utilising light transvaginal mesh after a prior hysterectomy. Only sexually active women with recurrent cystocele stage 3-4 according to POP-Q, who had previously undergone vaginal hysterectomy with anterior native tissue repair without apical fixation, were enrolled in the study. Women with previous mesh implant POP surgery, persistent vaginal infection or pelvic inflammatory disease were excluded. All patients were surgically treated between 2012 and 2015 using single-incision transvaginal mesh Calistar A. Sexual function was evaluated before a surgery and two years postoperatively. The assessment was accomplished via the standardised validated Czech translation of PISQ-12SF questionnaire. For each patient, age, BMI and parity were monitored. Out of all (89) eligible patients, 48 patients met inclusion criteria and were subsequently enrolled in our study. Two years postoperatively, 31 women (79.5%) improved their PISQ-12 score; five (12.8%) had equivalent scores, and three patients (7.7%) reported lower scores. Overall PISQ-12 score was 37.1 ± 2.6 postoperatively with a 2.9 ± 2.3 statistically significant positive difference compared to the score preceding surgery. The majority of patients undergoing surgery using Calistar A experienced a significant improvement in sexual function.IMPACT STATEMENTWhat is already known on this subject? Pelvic organ prolapse has a significant impact on women's sexual functioning in an adverse manner. Mesh implant repair is associated with lower rates of prolapse awareness and prolapse re-operation; however, it is linked with safety concerns. One of these concerns is the negative impact on women's sexual function. Evaluative study results following sexual function among women with mesh implant transvaginal repair are contradictory.What do the results of this study add? The results showed, that contrary to finding some of the previous studies, transvaginal mesh implant use could benefit patients with previous native tissue POP surgery failure with a low risk of sexual function deterioration.What are the implications of these findings for clinical practice and/or further research? The study provides clinical data for vaginal mesh implants on women's sexual function in the mid-term outcome. These data can be crucial for selecting the right POP surgical technique and evaluating its benefits and risks.

Super-Universality in Anderson Localization.

We calculate the effective spatial dimension d_{IR} of electron modes at critical points of 3D Anderson models in various universality classes (O,U,S,AIII). The results are equal within errors, and suggest the super-universal value d_{IR}=2.665(3)≈8/3. The existence of such a unique marker may help identify natural processes driven by Anderson localization, and provide new insight into the spatial geometry of Anderson transitions. The recently introduced d_{IR} is a measure-based dimension of Minkowski-Hausdorff type, designed to characterize probability-induced effective subsets.

Unusual Features of QCD Low-Energy Modes in the Infrared Phase.

It was recently proposed that there is a phase in thermal QCD (IR phase) at temperatures well above the chiral crossover, featuring elements of scale invariance in the infrared (IR). Here, we study the effective spatial dimensions d_{IR} of Dirac low-energy modes in this phase, in the context of pure-glue QCD. Our d_{IR} is based on the scaling of mode support toward thermodynamic limit, and hence is an IR probe. Ordinary extended modes, such as those at high energy, have d_{IR}=3. We find d_{IR}<3 in the spectral range whose lower edge coincides with λ_{IR}=0, the singularity of spectral density defining the IR phase, and the upper edge with λ_{A}, the previously identified Anderson-like nonanalyticity. Details near λ_{IR} are unexpected in that only exact zero modes are d_{IR}=3, while a thin spectral layer near zero is d_{IR}=2, followed by an extended layer of d_{IR}=1 modes. With only integer values appearing, d_{IR} may have a topological origin. We find similar structure at λ_{A}, and associate its adjacent thin layer (d_{IR}⪆2) with Anderson-like criticality. Our analysis reveals the manner in which nonanalyticities at λ_{IR} and λ_{A}, originally identified in other quantities, appear in d_{IR}(λ). This dimension structure may be important for understanding the near-perfect fluidity of the quark-gluon medium seen in accelerator experiments. The role of λ_{A} in previously conjectured decoupling of IR component is explained.

AIM2-driven inflammasome activation in heart failure.

AIMS: Interleukin-1ß (IL-1ß) is an important pathogenic factor in cardiovascular diseases including chronic heart failure (HF). The CANTOS trial highlighted that inflammasomes as primary sources of IL-1 ß are promising new therapeutic targets in cardiovascular diseases. Therefore, we aimed to assess inflammasome activation in failing hearts to identify activation patterns of inflammasome subtypes as sources of IL-1ß. METHODS AND RESULTS: Out of the four major inflammasome sensors tested, expression of the inflammasome protein absent in melanoma 2 (AIM2) and NLR family CARD domain-containing protein 4 (NLRC4) increased in human HF regardless of the aetiology (ischaemic or dilated cardiomyopathy), while the NLRP1/NALP1 and NLRP3 (NLR family, pyrin domain containing 1 and 3) inflammasome showed no change in HF samples. AIM2 expression was primarily detected in monocytes/macrophages of failing hearts. Translational animal models of HF (pressure or volume overload, and permanent coronary artery ligation in rat, as well as ischaemia/reperfusion-induced HF in pigs) demonstrated activation pattern of AIM2 similar to that of observed in end-stages of human HF. In vitro AIM2 inflammasome activation in human Tohoku Hospital Pediatrics-1 (THP-1) monocytic cells and human AC16 cells was significantly reduced by pharmacological blockade of pannexin-1 channels by the clinically used uricosuric drug probenecid. Probenecid was also able to reduce pressure overload-induced mortality and restore indices of disease severity in a rat chronic HF model in vivo. CONCLUSIONS: This is the first report showing that AIM2 and NLRC4 inflammasome activation contribute to chronic inflammation in HF and that probenecid alleviates chronic HF by reducing inflammasome activation. The present translational study suggests the possibility of repositioning probenecid for HF indications.

A multicentre, prospective, randomised controlled trial to assess the safety and effectiveness of cooling as an adjunctive therapy to percutaneous intervention in patients with acute myocardial infarction: the COOL AMI EU Pivotal Trial.

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<0.001). RESULTS: There were no differences in angiographic features and PPCI result between the groups. Intravascular temperature at wire crossing was 33.3+0.9°C. Infarct size/left ventricular (IS/LV) mass by cardiac magnetic resonance (CMR) at day 4-6 was 21.3% in the hypothermia group and 20.0% in the control group (p=0.540). Major adverse cardiac events at 30 days increased non-significantly in the hypothermia group (8.6% vs 1.9%; p=0.117) while cardiogenic shock (10.3% vs 0%; p=0.028) and paroxysmal atrial fibrillation (43.1% vs 3.8%; p<0.001) were significantly more frequent in the hypothermia group. CONCLUSIONS: The ZOLL Proteus intravascular cooling system reduced temperature to 33.3°C before PPCI in patients with anterior STEMI. Due to inconsistent patient logistics between the groups, this hypothermia protocol resulted in a longer ischaemic delay, did not reduce IS/LV mass and was associated with increased adverse events.

Post-Myocardial Infarction Heart Failure in Closed-chest Coronary Occlusion/Reperfusion Model in Göttingen Minipigs and Landrace Pigs.

The development of heart failure is the most powerful predictor of long-term mortality in patients surviving acute myocardial infarction (MI). There is an unmet clinical need for prevention and therapy of post-myocardial infarction heart failure (post-MI HF). Clinically relevant pig models of post-MI HF are prerequisites for final proof-of-concept studies before entering into clinical trials in drug and medical device development. Here we aimed to characterize a closed-chest porcine model of post-MI HF in adult Göttingen minipigs with long-term follow-up including serial cardiac magnetic resonance imaging (CMRI) and to compare it with the commonly used Landrace pig model. MI was induced by intraluminal balloon occlusion of the left anterior descending coronary artery for 120 min in Göttingen minipigs and for 90 min in Landrace pigs, followed by reperfusion. CMRI was performed to assess cardiac morphology and function at baseline in both breeds and at 3 and 6 months in Göttingen minipigs and at 2 months in Landrace pigs, respectively. Scar sizes were comparable in the two breeds, but MI resulted in a significant decrease of left ventricular ejection fraction (LVEF) only in Göttingen minipigs, while Landrace pigs did not show a reduction of LVEF. Right ventricular (RV) ejection fraction increased in both breeds despite the negligible RV scar sizes. In contrast to the significant increase of left ventricular end-diastolic (LVED) mass in Landrace pigs at 2 months, Göttingen minipigs showed a slight increase in LVED mass only at 6 months. In summary, this is the first characterization of post-MI HF in Göttingen minipigs in comparison to Landrace pigs, showing that the Göttingen minipig model reflects post-MI HF parameters comparable to the human pathology. We conclude that the Göttingen minipig model is superior to the Landrace pig model to study the development of post-MI HF.

Effective Number Theory: Counting the Identities of a Quantum State.

Quantum physics frequently involves a need to count the states, subspaces, measurement outcomes, and other elements of quantum dynamics. However, with quantum mechanics assigning probabilities to such objects, it is often desirable to work with the notion of a "total" that takes into account their varied relevance. For example, such an effective count of position states available to a lattice electron could characterize its localization properties. Similarly, the effective total of outcomes in the measurement step of a quantum computation relates to the efficiency of the quantum algorithm. Despite a broad need for effective counting, a well-founded prescription has not been formulated. Instead, the assignments that do not respect the measure-like nature of the concept, such as versions of the participation number or exponentiated entropies, are used in some areas. Here, we develop the additive theory of effective number functions (ENFs), namely functions assigning consistent totals to collections of objects endowed with probability weights. Our analysis reveals the existence of a minimal total, realized by the unique ENF, which leads to effective counting with absolute meaning. Touching upon the nature of the measure, our results may find applications not only in quantum physics, but also in other quantitative sciences.

The Effect of Magnesium on Reperfusion Arrhythmias in STEMI Patients, Treated With PPCI. A Systematic Review With a Meta-Analysis and Trial Sequential Analysis.

Aims: The restoration of coronary circulation plays a crucial role in treating ST-segment elevation myocardial infarction (STEMI), however successful reperfusion with primary percutaneous coronary intervention (PPCI) may induce life-threatening arrhythmias. The relation between myocardial electrical instability, as a background factor in reperfusion arrhythmia, and magnesium administered periprocedurally is still questionable. Several randomized clinical trials have been conducted predominantly in the thrombolysis era. Due to the contradictory results of these studies, there is little evidence of the potential preventive effect of magnesium on reperfusion arrhythmias. The aim of our study is to review and meta-analytically analyze data from all studies published so far in the PPCI era, comparing STEMI patients who have undergone primary PCI and received either magnesium or a placebo before the reperfusion procedure. Methods and Results: Our meta-analysis follows the points in the PRISMA protocol and, meets all of their criteria. We conducted a search in five scientific databases using the following keyword combination: (myocardial infarction OR myocardial injury OR acute coronary syndrome OR acs OR stemi) AND magnesium. The 7,295 collected publications were filtered with the Endnote program by title, abstract and full-text based on predefined criteria. A statistical analysis was performed on three randomized-controlled trials using three common parameters, involving 336 patients Trial sequential analysis (TSA) was applied to assess the risk of random error associated with sparse data and multiple testing which can affect cumulative meta-analysis. The incidence of ventricular tachycardias (VTs) was not significantly increased in the non-magnesium control group. (OR: 1.36; CI: 0.619; -2.986, P = 0.263). For the ejection fraction (EF), a non-significant decrease was observed in the magnesium group by weighted mean difference calculation. (WMD: 7.262, 95% CI: -0.238; 0.053; P = 0.057). There was significant decrease in the infarct zone wall motion index (IZWMSI) in the magnesium treatment group. (WMD: 0.384, 95% CI: -0.042; 0.811, P = 0.015). Based on the TSA assessments, the results of all parameters are not significant, objectively demonstrating the lack of reasonable data pertaining to our question. Conclusions: The preventive effect of magnesium on reperfusion arrhythmia associated with primary PCI can still be considered contradictory based on previous studies. In our study, we found, that magnesium is ineffective with a very weak evidence, due to the small number of patients and the biases of the included studies, and a well-designed clinical trial is needed in this area, based on the TSA.

Urinary orosomucoid: a new marker of cardiovascular risk in psoriatic patients?

PURPOSE: Psoriasis is one of the most common lifelong lasting dermatologic diseases. According to the latest studies, psoriatic patients have a higher risk of developing cardiovascular diseases. Psoriasis is considered as a systemic inflammatory disease. Several oxidative stress markers have been shown to be elevated in psoriasis. However, a panel of biomarkers has not been used yet. This study was aimed at exploring the connection between a panel of biomarkers (C-reactive protein, asymmetric dimethylarginine, uric acid, total antioxidant capacity, malondialdehyde, and orosomucoid [ORM]) and cardiovascular risk in psoriatic patients. PATIENTS AND METHODS: The inclusion criterion was the onset of psoriasis with skin lesions. Exclusion criteria were impaired renal function (eGFR<60 mL/min/1.73 m2), acute inflammations (urinary, respiratory, skin inflammation, etc), autoimmune disorders (rheumatoid arthritis, systemic lupus erythematosus, or inflammatory bowel disease), and any kind of biological antipsoriatic treatment. Patients with a medical history of myocardial infarction, coronary heart disease, stroke, transient ischemic attack, and carotid artery stenosis were also excluded. Biomarkers were measured by routine procedures, ELISA and HPLC. QRISK®2-2017 was used to assess 10-year risk of cardiovascular disease development. Psoriasis severity was measured by the Psoriasis Area and Severity Index. RESULTS: One hundred and fourteen psoriatic patients were enrolled. Only urinary orosomucoid and urinary orosomucoid/urinary creatinine (u-ORM/u-CREAT) ratio showed significant correlation with QRISK score (u-ORM, r=0.245; u-ORM/u-CREAT, r=0.309). When comparing mild psoriatic patients to moderate psoriatic patients, significant differences could only be found in u-ORM and u-ORM/u-CREAT ratio. CONCLUSION: There seems to be a connection between urinary ORM and cardiovascular risk. U-ORM and u-ORM/u-CREAT ratio could be used as an indicator of low-grade inflammation in mild and moderate psoriasis. However, it is the 10-year follow-up of cardiovascular events that will determine the usefulness of this biomarker panel.

Should Objective Structured Clinical Examinations Assist the Clinical Competency Committee in Assigning Anesthesiology Milestones Competency?

BACKGROUND: With the integration of Objective Structured Clinical Examinations into the Anesthesiology primary board certification process, residency programs may choose to implement Objective Structured Clinical Examinations for resident skill assessment. The aim of this study was to evaluate Objective Structured Clinical Examination-based milestone assessment and compare with Clinical Competency Committee milestone assessment that is based purely on clinical evaluations. METHODS: An annual Objective Structured Clinical Examination event was used to obtain milestone assessment of clinical anesthesia year 0-clinical anesthesia year 3 residents for selected milestones in patient care, professionalism, and interpersonal/communication skills. The Objective Structured Clinical Examination scenarios were different for each training level. The Clinical Competency Committee evaluated each resident semiannually based on clinical evaluations of resident performance. The Clinical Competency Committee milestone assessments from 2014 to 2016 that were recorded closest to the Objective Structured Clinical Examination event (±3 months) were compared to the Objective Structured Clinical Examination milestone assessments. A total of 35 residents were included in this analysis in 3 different training cohorts: A (graduates 2016, n = 12); B (graduates 2017, n = 10); and C (graduates 2018, n = 13). All residents participated in Objective Structured Clinical Examinations because their clinical anesthesia year 0 year and Clinical Competency Committee milestone data had been reported since December 2014. RESULTS: Both assessment techniques indicated a competency growth proportional to the length in training. Despite limited cumulative statistics in this study, average trends in the Objective Structured Clinical Examination-Clinical Competency Committee relationship indicated: (1) a good proportionality in reflecting competency growth; (2) a grade enhancement associated with Clinical Competency Committee assessment, dominated by evaluations of junior residents (clinical anesthesia year 0-clinical anesthesia year 1); and (3) an expectation bias in Clinical Competency Committee assessment, dominated by evaluation of senior residents (clinical anesthesia year 2-clinical anesthesia year 3). CONCLUSIONS: Our analysis confirms the compatibility of the 2 evaluation methods in reflecting longitudinal growth. The deviation of Objective Structured Clinical Examination assessments versus Clinical Competency Committee assessments suggests that Objective Structured Clinical Examinations may be providing additional or different information on resident performance. Educators might consider using both assessment methods to provide the most reliable and valid competency assessments during residency.

Does Gender Have Prognostic Value Among Patients with Myocardial Infarction? Analysis of the Data from the Hungarian Myocardial Infarction Registry.

Background: The authors analyzed data from the Hungarian Myocardial Infarction Registry (HUMIR) to examine the potential impact of gender on the treatment and 30-day and 1-year mortality of patients with myocardial infarction (MI). Materials and Methods: The National Registry of Myocardial Infarction included 42,953 patients between January 1, 2013 and December 31, 2016; 19,875 of whom were diagnosed with ST-elevation myocardial infarction (STEMI) and 23,078 with non-ST-elevation myocardial infarction (NSTEMI). The proportion of women was 39% and 41.9% in the two groups, respectively. Logistic regression analysis was performed adjusting for age, the year and month of hospital admission, smoking, as well as for five concomitant diseases and anamnestic data. We found that the odds ratio (OR) of performing percutaneous coronary intervention (PCI) was influenced by age, the year of treatment, prior stroke, and peripheral artery disease (PAD) in both patient groups. Results: Gender had an impact on treatment in both cases; women had significantly fewer PCIs (OR = 0.86 confidence interval [95% CI: 0.77-0.95] in the STEMI group, OR = 0.75 [95% CI: 0.70-0.82] in the NSTEMI group). Age and PCI, PAD, and diabetes mellitus proved to be prognostic factors for 30-day and 1-year mortality in both groups. In the STEMI group, hypertension proved to be of prognostic value for both 30-day and 1-year mortality, whereas prior MI, stroke, and smoking only affected 1-year mortality. Similarly, in the NSTEMI group, prior stroke was also of prognostic value for 30-day and 1-year mortality, whereas prior MI, hypertension and smoking were only associated with 1-year mortality. Conclusions: The independent prognostic value of gender could not be proven for any of the MI types or follow-up periods. In conclusion, gender influenced the treatment of patients with MI but had no significant impact on prognosis in itself.