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.

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.

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.

Effects of Transendocardial Delivery of Bone Marrow-Derived CD133+ Cells on Left Ventricle Perfusion and Function in Patients With Refractory Angina: Final Results of Randomized, Double-Blinded, Placebo-Controlled REGENT-VSEL Trial.

RATIONALE: New therapies for refractory angina are needed. OBJECTIVE: Assessment of transendocardial delivery of bone marrow CD133+ cells in patients with refractory angina. METHODS AND RESULTS: Randomized, double-blinded, placebo-controlled trial enrolled 31 patients with recurrent Canadian Cardiovascular Society II-IV angina, despite optimal medical therapy, ≥1 myocardial segment with inducible ischemia in Tc-99m SPECT who underwent bone marrow biopsy and were allocated to cells (n=16) or placebo (n=15). Primary end point was absolute change in myocardial ischemia by SPECT. Secondary end points were left ventricular function and volumes by magnetic resonance imaging and angina severity. After 4 months, there were no significant differences in extent of inducible ischemia between groups (summed difference score mean [±SD]: 2.60 [2.6] versus 3.63 [3.6], P=0.52; total perfusion deficit: 3.60 [3.6] versus 5.01 [4.3], P=0.32; absolute changes of summed difference score: -1.38 [5.2] versus -0.73 [1.9], P=0.65; and total perfusion deficit: -1.33 [3.3] versus -2.19 [6.6], P=0.65). There was a significant reduction of left ventricular volumes (end-systolic volume: -4.3 [11.3] versus 7.4 [11.8], P=0.02; end-diastolic volume: -9.1 [14.9] versus 7.4 [15.8], P=0.02) and no significant change of left ventricular ejection fraction in the cell group. There was no difference in number of patients showing improvement of ≥1 Canadian Cardiovascular Society class after 1 (41.7% versus 58.3%; P=0.68), 4 (50% versus 33.3%; P=0.63), 6 (70% versus 50.0%; P=0.42), and 12 months (55.6% versus 81.8%; P=0.33) and use of nitrates after 12 months. CONCLUSION: Transendocardial CD133+ cell therapy was safe. Study was underpowered to conclusively validate the efficacy, but it did not show a significant reduction of myocardial ischemia and angina versus placebo. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01660581.

An optical coherence tomography study of neointimal morphology and strut coverage at different time intervals from implantation of biodegradable polymer-coated sirolimus-eluting stents.

OBJECTIVES: The aim of the study was to capture the evolution of neointima after implantation of a biodegradable polymer-coated, sirolimus-eluting, cobalt-chromium coronary stent system (BP-DES). BACKGROUND: Optical coherence tomography (OCT) suggests that in-stent neointimal morphology influences clinical outcomes after DES implantation. METHODS: Sixty patients treated with single BP-DES implantation were examined by quantitative coronary angiography (QCA) and OCT at 3, 6, and 12-month follow-up. RESULTS: Median late lumen loss by QCA (mm) was 0.04 (IQR 0, 0.08), 0.17 (IQR 0, 0.32), and 0.14 (IQR 0.07, 0.31) at 3, 6, and 12-month follow-up respectively (P = 0.03). OCT cross-section multilevel analysis showed uncovered struts in 3.90%, 1.78%, and 0.02% of struts respectively (P = 0.03). The corresponding malapposition rates were 0.12%, 0.04%, and 0%. Lipid-rich neointima was observed only at 12-month follow-up in one restenotic lesion (0.77% cross-sections) that was accountable for the only target vessel revascularization. The homogeneous pattern was prevalent at all three time points, but its incidence displayed an upward trend (3 months: 59%; 6 months: 71%; 12 months: 88%) despite no difference in neointimal volume between 6 and 12 months. Conversely, a trend could be observed of decreasing incidence of heterogeneous pattern as the follow-up length increased. CONCLUSIONS: In this study of a single-type BP-DES, the majority of stent struts were covered within 3 months from implantation. While the quantitative neointimal accumulation plateaued at 6 months with no further significant increase beyond 6 months, the neointima continued to evolve qualitatively and mature along with better strut coverage between 6 and 12 months after implantation.

Assessment of quality of life in patients after surgical and transcatheter aortic valve replacement.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) and minimally invasive aortic valve replacement (mini-thoracotomy, mini-sternotomy, MIAVR) have become an appealing alternative to conventional surgical (SAVR) treatment of severe aortic stenosis (AS) in high-risk patients. BACKGROUND: Aim of the study was to evaluate the quality of life (QoL) in patients with AS and treated with transfemoral TAVI, SAVR, mini-thoracotomy and mini-sternotomy. METHODS: One hundred and seventy-three patients with symptomatic AS were enrolled in 2011-2013. TAVI group consisted of 39 patients (22.5%), mini-sternotomy was performed in 44 patients (25.5%), mini-thoracotomy in 50 (29%), and AVR in 40 patients (23%). QoL was assessed perioperatively, 12 and 24 months after aortic valve replacement (AVR) by Minnesota Living with Heart Failure Questionnaire (MLHFQ) and EQ-5D-3L. RESULTS: Median follow-up was 583.5 (IQR: 298-736) days. Improvement of health status after procedure in comparison with pre-operative period was significantly more often reported after TAVI in perioperative period (90.3%; P = 0.004) and 12 months after procedure (100%, P = 0.02). Global MLHFQ, physical and emotional dimension score at 30-day from AVR presented significant improvement after TAVI in comparison with surgical methods (respectively: 8.3(±8.6), P = 0.003; 4.1(±5.9), P = 0.01; 1.5(±2.6), P = 0.005). Total MLHFQ score was significantly lower (better outcome) in TAVI patients 1 year after procedure (4.8(±6.8), P = 0.004), no differences in somatic and emotional component were found. No differences were found in MLHFQ score 24 months after AVR. Data from EQ-D5-3L questionnaire demonstrated significant improvement of QoL at 30-day follow-up after TAVI in comparison with surgical methods (1.2(±1.7), P = 0.0008). CONCLUSIONS: TAVI improves QoL in perioperative and 12 months observation in comparison with mini-thoracotomy, mini-sternotomy and SAVR. Improvement in QoL was obtained in both generic and disease specific questionnaires. © 2016 Wiley Periodicals, Inc.

Impact of direct stenting on outcome of patients with ST-elevation myocardial infarction transferred for primary percutaneous coronary intervention (from the EUROTRANSFER registry).

OBJECTIVES: We sought to evaluate the impact of direct stenting technique on angiographic and clinical outcomes of patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary angioplasty (PCI). METHODS: Data on 1,419 patients who underwent immediate PCI for STEMI with implantation of ≥1 stent within native coronary artery were retrieved from the EUROTRANSFER Registry database. Patients were stratified based on the stent implantation technique: direct (without predilatation) vs. conventional stenting. Propensity score adjustment was used to control possible selection bias. RESULTS: Direct stenting technique was used in 276 (19.5%) patients. Remaining 1,143 patients were treated with stent implantation after balloon predilatation. Direct compared with conventional stenting resulted in significantly greater rates of postprocedural TIMI grade 3 flow (conventional vs. direct stenting: 91.5% vs. 94.9%, adjusted OR 2.09 (1.13-3.89), P = 0.020), and lower risk of no-reflow (3.4% vs. 1.4%, adjusted OR 0.31 (0.10-0.92), P = 0.035). The rates for ST-segment resolution >50% after PCI were higher in patients treated with direct stenting technique (76.3% vs. 86.2%, adjusted OR 1.64 (1.10-2.46), P = 0.016). A significant reduction in 1-year mortality in patients from the direct stenting group compared with the conventional stenting group, even after adjustment for propensity score was observed (6.5% vs. 2.9%, adjusted OR 0.45 (0.21-0.99), P = 0.047). CONCLUSIONS: When anatomically and technically feasible, the use of direct stenting technique may result in improved long-term survival in patients with STEMI undergoing primary PCI.

Borderline trend towards long-term mortality benefit from drug eluting stents implantation in ST-elevation myocardial infarction patients in Poland-data from NRDES registry.

OBJECTIVES: To analyze long-term outcome of ST-Elevation Myocardial Infarction (STEMI) and non-STEMI (NSTEMI) patients treated with Drug Eluting Stents (DES) stents with regard to mortality and stent thrombosis rates based on the national Polish PCI registry database. BACKGROUND: Only a few studies suggested potential trend towards lower mortality in STEMI patients treated with DES. Current European Society of Cardiology STEMI guidelines recommend DES use only with one restriction to suspected patient poor compliance or contraindication to dual antiplatelet therapy. METHODS: Thirteen high-volume interventional cardiology centers in Poland enrolled patients in National Registry of Drug Eluting Stents (NRDES) Registry from October 2010 till October 2011. RESULTS: There were 2686 patients enrolled in NRDES Registry. Eighty five patients (3%) had both DES and BMS implanted at index PCI procedure and were excluded from further analysis. A subpopulation of STEMI (1709; 66%) and NSTEMI (892; 34%) patients was selected for BMS vs DES comparison. A significant difference in favor of DES group for 1-year mortality was found in STEMI subgroup (P < 0.0001-unadjusted and P = 0.0497 after propensity score adjustment). No such differences were noticed for NSTEMI subgroup or stent thrombosis comparisons. CONCLUSIONS: A strong selection bias for DES stents was observed with regard to demographic and angiographic characteristics in both STEMI and NSTEMI. DES implantation was associated with similar ischemic outcome to BMS at 1-year follow-up. STEMI patients with DES presented a trend towards lower long-term mortality at 1 year in comparison to BMS.

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 2mm 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.

Predictors of coronary and carotid atherosclerosis in patients with severe degenerative aortic stenosis.

BACKGROUND: Patients with degenerative aortic stenosis (AS) exhibit elevated prevalence of coronary artery disease (CAD) and internal carotid artery stenosis (ICAS). Our aim was to investigate prevalence of significant CAD and ICAS in relation to demographic and cardiovascular risk profile among patients with severe degenerative AS. METHODS: We studied 145 consecutive patients (77 men and 68 women) aged 49-91 years (median, 76) with severe degenerative AS who underwent coronary angiography and carotid ultrasonography in our tertiary care center. The patients were divided into two groups according to the presence of either significant CAD (n=86) or ICAS (n=22). RESULTS: The prevalence of significant CAD or ICAS was higher with increasing number of traditional risk factors (hypertension, hypercholesterolemia, diabetes, smoking habit) and decreasing renal function. We found interactions between age and gender in terms of CAD (p=0.01) and ICAS (p=0.06), which was confirmed by multivariate approach. With the reference to men with a below-median age, the prevalence of CAD or ICAS increased in men aged >76 years (89% vs. 55% and 28% vs. 14%, respectively), whereas the respective percentages were lower in older vs. younger women (48% vs. 54% and 7% vs. 17%). CONCLUSIONS: In severe degenerative AS gender modulates the association of age with coronary and carotid atherosclerosis with its lower prevalence in women aged >76 years compared to their younger counterparts. This may result from a hypothetical "survival bias", i.e., an excessive risk of death in very elderly women with severe AS and coexisting relevant coronary or carotid atherosclerosis.

A clinical evaluation of the ProNOVA XR polymer-free sirolimus eluting coronary stent system in the treatment of patients with de novo coronary artery lesions (EURONOVA XR I study).

AIMS: Evaluation of safety and efficacy of ProNOVA XR, a new generation of polymer-free sirolimus eluting stents (SES), utilizing a pharmaceutical excipient for timed release of sirolimus from the XR platform. METHODS AND RESULTS: Safety and efficacy of ProNOVA XR coronary stent system was examined in EURONOVA prospective, single arm, multi-center registry of 50 patients with de novo native coronary lesions up to 28 mm in length in arteries between 2.25 and 4 mm. At 6-month, in-stent late lumen loss by QCA was 0.45 ± 0.41 mm and in-stent neointimal volume obstruction in the IVUS sub-study was 14 ± 11%. One-year clinical follow-up revealed a favorable safety profile, with 2% of in-hospital MACE and 6.4% of MACE from hospital discharge up to 12 months (including 1 cardiac death >30 days after stent implantation and 2 TLRs). According to the ARC definition, there was no definite or probable stent thrombosis and 1 possible stent thrombosis (2%) up to 12 months of clinical follow-up. CONCLUSIONS: In this preliminary evaluation, ProNOVA XR polymer-free sirolimus eluting stent system appeared safe with an early promise of adequate effectiveness in the treatment of de novo coronary lesions in up to 12 months of clinical, angiographic and IVUS follow-up.

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.

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.

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.

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.

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.

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.

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.

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.