Search

Aim To assess the effects of 1- or ≥3-month dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients who received biodegradable-polymer sirolimus-eluting stents for complex percutaneous coronary intervention (PCI) and/or acute coronary syndrome (ACS). Methods and results In the MASTER DAPT trial, 3383 patients underwent non-complex (abbreviated DAPT, n = 1707; standard DAPT, n = 1676) and 1196 complex (abbreviated DAPT, n = 588; standard DAPT, n = 608) PCI. Co-primary outcomes at 335 days were net adverse clinical events [NACE; composite of all-cause death, myocardial infarction, stroke, and bleeding academic research consortium (BARC) 3 or 5 bleeding events]; major adverse cardiac or cerebral events (MACCE; all-cause death, myocardial infarction, and stroke); and Types 2, 3, or 5 BARC bleeding. Net adverse clinical events and MACCE did not differ with abbreviated vs. standard DAPT among patients with complex [hazard ratio (HR): 1.03, 95% confidence interval (CI): 0.69–1.52, and HR: 1.24, 95% CI: 0.79–1.92, respectively] and non-complex PCI (HR: 0.90, 95% CI: 0.71–1.15, and HR: 0.91, 95% CI: 0.69–1.21; Pinteraction = 0.60 and 0.26, respectively). BARC 2, 3, or 5 was reduced with abbreviated DAPT in patients with and without complex PCI (HR: 0.64; 95% CI: 0.42–0.98, and HR: 0.70; 95% CI: 0.55–0.89; Pinteraction = 0.72). Among the 2816 patients with complex PCI and/or ACS, NACE and MACCE did not differ and BARC 2, 3, or 5 was lower with abbreviated DAPT. Conclusion In HBR patients free from recurrent ischaemic events at 1 month, DAPT discontinuation was associated with similar NACE and MACCE and lower bleeding rates compared with standard DAPT, regardless of PCI or patient complexity. Clinical Trial Registration This trial is registered with ClinicalTrials.gov, number NCT03023020, and is closed to new participants, with follow-up completed.

Bakground Current recommendations indicate invasive coronary angiography (ICA) as the first-line anatomic test in stable patients with high probability of significant coronary artery disease (CAD). However, this approach effects in increased proportion of non-actionable ICAs (not followed by invasive treatment). Clinical efficacy and the safety of the strategy employing coronary computed tomography angiography (CCTA) as the first-choice imaging test in this population has been recently evaluated in the CAT-CAD randomised trial. Based on prospectively collected data we aimed to evaluate its economic outcomes. Methods One hundred and twenty consecutive stable patients with indications to invasive CAD diagnosis were randomised 1 : 1 to undergo ICA versus CCTA as the first-line anatomic test. Outcomes were evaluated during the entire diagnostic and therapeutic course. Simultaneously, we counted the number of medical resources, such as: CCTAs, ICAs, percutaneous coronary interventions (PCIs), coronary artery bypass grafts (CABGs), functional tests, stents, clinical visits, hospital days. We estimated the cumulative cost for each strategy by multiplying medical resources by its standarised costs. Clinical Trials: NCT 02591992. Results Economic analysis showed that the total cost of CAD diagnosis was significantly higher in the direct ICA group as compared to the CCTA group ($305,962 vs. $234,550), with the median per-patient cost of $2838 (2,838–2,838) vs. $409 (409–3,247), respectively (p = 0.0001). Similarly, the entire diagnostic and therapeutic course was significantly more expensive in the direct ICA group ($603,746 vs. $354,690), with the median per-patient cost of $2,838 (2,838–16,102) vs. $409 (409–9,930), respectively (p < 0.0001) (Figure 1). Figure 1 Main results and economical analysis of the CAT-CAD trial Conclusions Application of CCTA as the first-line anatomic test in patients with suspected significant CAD decreased the total costs of diagnosis. This benefit can be achieved by reducing the number of invasive tests and hospitalisations., Background Thick cap fibroatheroma (TCFA) is considered as one of the features of vulnerable plaque. However, current methodology is based on measurement in arbitrary points and ignores 3-dimensional structure of coronary arteries. Purpose The aim of our study was to compare TCFA area using 3-demensional programming between stable angina (SA) and ST-elevation myocardial infarction (STEMI) patients using optical coherence tomography. Methods We have compared non-culprit plaques in 27 SA and 27 STEMI patients undergoing percutaneous coronary intervention. The TCFA was defined as a fibrous cap thickness lower than 80 μm. Whole TCFA area, number of spots with TCFA and average area of each spot were measured. Results Patients characteristics between two groups were comparable. However, patients with STEMI were less frequently on statins (17% vs. 70%; p < 0.001) and β-blockers (4% vs. 48%; p = 0.001). STEMI patients had greater TCFA area (1.2 ±1.3 vs. 0.2 ±0.5 mm2; p < 0.001), bigger largest TCFA spot (0.5 ±0.5 vs. 0.1 ±0.2 mm2; p < 0.001), greater number of TCFA spots (10.0 ±10.1 vs. 3.2 ±4.4; p = 0.002), as well as greater mean spot area (0.18 ±0.36 vs. 0.05 ±0.04 mm2; p < 0.001) (Figure 1). Figure 1 Optical coherence tomography example of fibrous cap thickness (FCT) of stable angina (SA) and ST elevation myocardial infarction (STEMI) patient. Red colour represents FCT lower than 80 μm, green from 80–200 μm, and blue more than 200 μm Conclusions The STEMI patients have greater TCFA area in non-culprit plaques, which may explain higher rate of adverse events in this groups as compared to SA patients., Background Prevalence of coronary artery disease as well as cardiac mortality varies between Asians and White patients. However, the link between race and plaque characteristics among patients with coronary artery disease remains largely unexplored. Purpose The aim of our study was to compare the detailed culprit plaque characteristics between East Asian and White patients with coronary artery disease using optical coherence tomography. Methods We performed propensity score matching between Asian and White patients at 1 : 1 ratio based on the following variables: (1) age; (2) gender; (3) clinical presentation; (4) diabetes mellitus; (5) hyperlipidemia; (6) culprit lesion location. Overall, 101 East Asian patients were matched to 101 White patients. Results Majority of patients were male (80.2%) and average age was 60 years. Other than higher body mass index (BMI) in White patients (29.6 ±5.1 vs. 24.2 ±3.1 kg/m2; p < 0.001) baseline demographics were comparable between the two groups. In those patients presented with acute coronary syndrome (ACS) no differences in underlying pathology (rupture vs. erosion) were found between the two races (Table I). In adjusted analysis, lesion length was longer, lipid length and lipid index were greater, and mean reference area was larger in White patients compared to East Asian patients. Table I Optical coherence tomography findings Parameter White (n = 101) East Asians (n = 101) P-value Underlying pathology (ACS), n: 62 50 0.935 Rupture, n (%) 32 (50.0) 33 (51.6) Erosion, n (%) 20 (31.3) 17 (26.6) Lesion length [mm] 18.0 ±6.0 14.6 ±5.4 0.002 Lipid core length [mm] 9.4 ±4.6 7.2 ±3.8 0.044 Mean lipid arc [°] 169.2 ±41.8 148.8 ±40.7 0.002 Lipid index 1635 ±987 1104 ±730 0.006 Mean reference area [mm2] 8.1 ±3.0 6.5 ±2.4 0.021 Values are mean ± standard deviation (SD) or n (%). Conclusions There are significant differences in plaque morphology between East Asian and White patients even after controlling for confounders. Our findings underscore key differences in atherosclerosis between East Asian and White populations and may have to be taken into consideration in interpreting the results of future research., Purpose The aim of the study was to define cardiac complications risk during antegrade coronary artery chronic total occlusion (CTO) recanalization. Methods From 2009 to 2013 the attempt of antegrade coronary artery CTO recanalization was performed in 217 patients. Depending on success of recanalization patients were divided into: group 1 (n = 158) – successful procedure, group 2 (n = 59) – unsuccessful attempt of CTO recanalization. Results Occurrence of cardiac complications was noted in 57 patients (26.3% of cases) – coronary artery dissection (11.5%), perforation of a coronary artery (5.5%) and coronary artery spasm (5.1%) among them. We didn’t note any cases of cardiac death, an acute myocardial infarction, and an immediate coronary artery bypass surgery. All perforation cases were induced by wire manipulation, dissections most often occurred during coronary stent implantation, coronary spasm developed at all stages of CTO recanalization. Frequency of cardiac complications was identical in both groups (25.9% in group 1 vs. 27.1 % in group 2, p = 0.8637). Unsuccessful CTO recanalization was associated with higher perforation rate (2.5% in group 1 vs. 13.6% in group 2, p = 0.0266), especially Ellis II type perforation (2.5% in group 1 vs. 10.2% in group 2, p = 0.0039). Conclusions The obtained data confirm a high safety profile of antegrade CTO recanalization emphasized by absence of “big”” cardiovascular complications and suitable outcome in coronary artery dissection and perforation cases., Purpose The aim of the study was to assess the accuracy of Pd/Pa ratio registered during submaximal hyperemia induced by contrast medium (CMR) in predicting of fractional flow reserve (FFR), quantitative flow ratio (QFR) and instantaneous wave-free ratio (iFR). Methods Resting Pd/Pa, CMR, FFR, QFR and iFR were measured in 110 intermediate coronary stenosis. CMR was obtained after intracoronary injection of contrast medium. FFR was measured after intravenous administration of adenosine. QFR was derived from fixed empiric hyperemic flow velocity based on coronary angiography. The iFR was calculated by measuring the resting pressure gradient across a coronary lesion during the portion of diastole when microvascular resistance is low and stable. Results Forty four patients with 110 intermediate coronary stenosis were enrolled. Mean baseline Pd/Pa was 0.93 ±0.05. Mean CMR value was similar to FFR value (0.83 ±0.09 vs. 0.81 ±0.09, p = 0.13) and QFR (0.81 ±0.1, p = 0.69) and iFR (0.9 ±0.07, p = 0.1). Forty-six vessels (41.8%) had FFR ≤ 0.80. Fifty (45.5%) vessels had CMR ≤ 0.83. Forty-four (40.0%) vessels had QFR ≤ 0.80. Thirty-eight (34.5%) vessels had iFR ≤ 0.89. Resting Pd/Pa, FFR, QFR and iFR correlated with CMR (r = 0.83, r = 0.98, r = 0.96, r = 0.81, respectively, p < 0.001 for all). The optimal cutoff value of CMR was 0.83 for prediction of FFR ≤ 0.80 with sensitivity, specificity, and accuracy of 96.9%, 97.8%, and 97.3% respectively. A 100% sensitivity was observed for cutoff value of 0.82 and a 100% specificity for cutoff value of 0.84; AUC = 0.998 (0.995–1.00); p < 0.001. Conclusions CMR seems to be accurate in predicting the functional significance of coronary stenosis assessed with FFR, iFR and QFR., Background Rotational atherectomy (RA) is a method of treatment of highly calcified lesions that cannot be treated with traditional percutaneous coronary intervention (PCI). Despite higher access site complication rates, transfemoral approach (TFA) may be preferred to obtain proper backup, facilitate atherectomy and achieve procedural success. In this study we compare transradial (TRA) and TFA in RA patients. Methods We retrospectively analysed data in 177 patients who underwent RA using either TFA (n = 54) or TRA (n = 123). Results Patients with TRA were more likely to be males (73% vs. 57%, p < 0.05) with no difference in age (71 ±10 years). The prevalence of risk factors and comorbidities was similar in groups, however EuroSCORE II mortality risk was higher in the TFA group (3.15% vs. 2.1%, p < 0.05). Procedural success was achieved in 93% cases with no inter-group difference. TFA was associated with higher rates of major bleeding (13% vs. 1%), more frequent usage of pacing (30% vs. 3%), higher contrast volume (280 ml vs. 250 ml), and longer hospital stay (3 vs. 2 days, all p < 0.05). There was no difference in total in-hospital or 1-year stroke, acute coronary syndrome, decompensated heart failure or mortality rates. Conclusions Rotational atherectomy is a challenging and demanding technique and TFA may seem to be optimal approach to achieve optimal effect, however our data show that TRA is associated with lower bleeding rates with the same success as compared with TFA. It is necessary to include TRA in complex coronary procedures training to achieve best results and minimize the risk of complications., Background There paucity of real-life data on left main (LM) therapy with self-expandable drug eluting stent (DES). The following Stentys Left Main registry aimed to assess clinical outcomes of LM percutaneous coronary intervention (PCI) using such self-expandable platform (Stentys). Methods A multicenter registry consists of 154 consecutive patients treated with Stentys implanted to LM. Major adverse cardiac and cerebral events (MACCE) such as composite of death, myocardial infarction (MI) and stroke were recorded at 30-days and 12-months. Results Patients’ mean age was 69 ±10.5 years. Acute coronary syndrome was diagnosed in 40 (26.5%) cases including NSTE-ACS (n = 28, 18.1%) and STEMI (n = 12, 7.8%). Median EuroSCORE II was 2.2% (IQR: 1.0–4.5). Prior CABG were performed in 40 (25.9%) patients. Mean LVEF was 46.0 ±11.9%. Distal LM bifurcation lesions were present in 152 (98.7%) patients (Medina: 1,1,1 (n = 59, 38.3%), 1-1-0 (n = 62, 40.2%), 1-0-1 (n = 16, 10.4%), 1-0-0 (n = 17, 11.1%)). There was a significant difference between proximal and distal reference diameter of the lesions (4.0 (IQR: 3.9–4.1) vs. 2.9 (IQR: 2.8–3.0), p < 0.001). Stentys DES was implanted in the sequence LM to LAD in 107 (69.4%) cases. Stentys strut disconnection for SB access were done in 94 (61.2%) patients, because of angiographically significant stenosis of SB. Final kissing balloon inflation was performed in 25 (16%) cases. Six patients required ventricular assist devices during procedure. One patient had an acute stent thrombosis (ST) and 1 patient had late ST post PCI, there were 7 (4.5%) cardiac death, 2 (1.2%) target lesion revascularization (TLR), 3 (1.9%) MI and 9 (5.8%) MACCE during 30 days follow-up. At 12-month follow-up there were 9 (5.8%) cardiac death, 9 (5.8%) TLR, 7 (4.5%) MI and 19 (12.3%) MACCE. In 2 cases, TLR was the cause of MI. Conclusions The real-life multicenter registry showed that the use of Stentys DES self-expanding coronary stent is associated with acceptable short and midterm outcomes in all-comer population of patients including ACS with significant LM stenosis., Background Acute myocardial infarction may be the first manifestation of coronary artery disease (CAD). The aim of this study was to compare demographics, past medical history and angiographic presentation of patients with myocardial infarction as a first or subsequent manifestation of CAD. Methods Patient with STEMI or NSTEMI treated with PCI were enrolled to this registry study in Poland in 2014–2016 (the national ORPKI registry). Results There were 123 965 patients who fulfilled inclusion criteria. Acute myocardial infarction as first CAD presentation was diagnosed in 77% of cases (Table I). Table I Baseline characteristics Parameter First manifestation of CAD Subsequent manifestation of CAD P-value Age [years] 66 ±12 69 ±11 < 0.001 Gender – females 34% 30% < 0.001 Time from pain onset till angiography [min] – median 390 538 < 0.001 Diabetes mellitus 19% 33% < 0.001 Smoking 28% 20% < 0.001 Arterial hypertension 61% 77% < 0.001 COPD 2% 4% < 0.001 Femoral access site 27% 36% < 0.001 1-vessel disease in angiography 46% 30% < 0.001 Conclusions Patients with acute myocardial infarction as first CAD manifestation constitute ca. 75% of all cases and are characterized by lower mean age, more frequent female gender and cigarette smokers. These patients are also prone to more frequent use of radial approach and are characterized by single vessel disease in angiography. The time from pain onset to angiography was significantly (by ca. 2 h) lower in patients with first CAD manifestation., Background Secondary prevention of cardiovascular disease (CVD) aims to prevent the recurrence of cardiovascular events in patients already diagnosed with CVD. It involves the optimal pharmacotherapy and modification of the risk factors, understood as lifestyle changes in the area of physical activity, diet and addiction habits like smoking. Purpose The aim of the study was to analyze the realization of guidelines for secondary prevention of CVD in clinical practice. Methods: We included 320 consecutive patients (92 women) with a mean age of 64.8 ±9.0 years hospitalized at the 2nd Department of Cardiology and Cardiovascular Interventions, University Hospital in Krakow. Patients had a history of acute myocardial infarction and/or had undergone percutaneous coronary interventions, coronary artery bypass grafting, or pharmacologically treated CVD. Results The mean body mass index (BMI) was 28.7 ±4.5 kg/m2 (45.6% of patients were overweight, 34.3% were obese). At the time of hospitalization, 16.3% of patients were active smokers; 43.8% smoked cigarettes for 28.2 ±12.4 years, 20.2 ±10.8 cigarettes per day. Only 15.4% of patients with acute myocardial infarction had cardiac rehabilitation after hospital discharge. In laboratory tests, mean level of total cholesterol 4.2 ±1.4 mmol/l; LDL 2.2 ±1.0 mmol/l; HDL 1.2 ±0.4 mmol/l; triglyceride 1.7 ±1.7 mmol/l. The mean fasting glucose in people without diabetes was 5.6 ±0.8 mmol/l; HbA1c in diabetics 7.1 ±1.2%. Furthermore, diet was assessed using study-dedicated questionnaire and level of physical activity was evaluated by The International Physical Activity Questionnaire. Conclusions In the studied group, there were differences from the recommendations for secondary prevention of CVD. There is a necessity to improve the care of patients with CVD. Adherence to recommendations may reduce the risk of recurrent cardiac events., Background Radial artery (RA) access for percutaneous coronary interventions (PCI) is gaining more supporters each year. It is considered safer than commonly used femoral access, however it also has its drawbacks. One of the major complications of radial access is radial artery occlusion (RAO). Purpose The aim of the study was to assess the predicting factors of RAO in patients undergoing various coronary interventions. Methods We prospectively evaluated clinical and laboratory data of 351 consecutive patients. Presence of blood flow in radial artery was evaluated in all patients by plethysmography on the next day after the procedure. Results RAO was observed in 52 (15%) patients. Differences between patients with and without RAO are presented in table below. Univariate logistic regression models showed compression time (OR = 1.6; 95% CI: 1.3–1.9; p < 0.001) female sex (OR = 2.8; 95% CI: 1.5–5.2; p < 0.001), coronary angiography as the only procedure (OR = 2.3; 95% CI: 1.2–4.6; p = 0.02), height (OR = 0.94; 95% CI: 0.91–0.98; p = 0.002), weight (OR = 0.97; 95% CI: 0.95–0.99; p = 0.02), and eGFR (OR = 0.98; 95% CI: 0.97–0, p = 0.006) to be predictors of RAO. In multivariate model time of RA compression (OR = 1.8, 95% CI: 1.4–2.2; p < 0.001) and coronary angiography as the only performed procedure (OR = 3.8; 95% CI: 1.7–8.7; p = 0.001) remained independent predicting factors of RAO (Table I). Table I Clinical and procedural characteristics Parameter RAO + RAO – All patients P-value N (%) 52 (15) 299 (85) 351 (100) Female sex, n (%) 29 (56) 92 (31) 121 (34) < 0.001 Age [years] 66 ±9 66 ±11 66 ±11 0.83 Height [cm] 165 ±9 170 ±8 169 ±9 0.001 Weight [kg] 78 ±16 82 ±14 82 ±15 0.005 Diabetes, n (%) 13 (25) 78 (26) 91 (26) 0.86 Hypertension, n (%) 49 (94) 271 (91) 320 (91) 0.39 Prior CABG, n (%) 4 (8) 27 (9) 31 (9) 0.75 Prior MI, n (%) 19 (37) 130 (43) 149 (42) 0.35 HFrEF, n (%) 10 (19) 64 (21) 74 (21) 0.72 Current smoker, n (%) 17 (33) 70 (23) 87 (25) 0.15 eGFR [ml/min/1.73 m2] 80 ±28 90 ±22 88 ±23 0.004 Compression time [h] 4.3 ±1.9 3.0 ±1.2 3.2 ±1.4 < 0.001 Coronary angiography only, n (%) 40 (77) 176 (59) 216 (62) 0.01 Coronary angiography + PCI, n (%) 11 (21) 100 (33) 111 (32) 0.08 PCI only, n (%) 1 (2) 23 (8) 24 (7) 0.12 5 Fr sheath only, n (%) 0 7 (2) 7 (2) 0.56 5 Fr catheter only, n (%) 28 (54) 146 (49) 174 (41) 0.5 GP2b3a inhibitors, n (%) 7 (13) 38 (13) 45 (13) 0.8 Urgent procedure, n (%) 25 (48) 102 (34) 127 (36) 0.05 UFH dose [× 1000 U] 4.1 ±1 5.1 ±1.6 4.9 ±1.6 0.07 Conclusions RAO is not uncommon after PCI. Its clinical significance is still unknown. Higher incidence of RAO after coronary angiography in our population may be attributed to lower doses of heparin administered during this procedure which may need to be increased. Compression times after all procedures should be limited to minimum., Purpose The aim of the study was to assess survival in CTEPH patients treated with balloon pulmonary angioplasty (BPA) in comparison to pulmonary endarterectomy (PEA) and conservative treatment (CON). Methods We enrolled 68 patients with the diagnose of inoperable or persistent CTEPH confirmed by CTEPH-team treated with BPA from 2013 to 2017. The survival of this population was compared to historical control group (n = 112) CTEPH patients which have undergone PEA (n = 46) or been treated conservatively (n = 66). Results The median survival duration observed in BPA population was 22.1 ±14.8 months. The cumulated survival index was 94.2% (95% CI: 88–100%) in the 50th month. In the historical control group the cumulated index of survival after PEA was 90.9% (95% CI: 84–97%) after 50 months (log-rank test vs. the BPA-treated group; 0.31) and in the patients receiving conservative treatment the survival rates were 70.1% (95% CI: 56–84%) after 50 months, respectively. The survival rate of patients treated with BPA was better than that of the historical CTEPH patients (Figure 1) only on pharmacotherapy (p < 0.001), and was similar to that of the patients treated with PEA (p = 0.31). Figure 1 Cumulative survival in CTEPH patients treated with different methods BPA – treated with balloon pulmonary angioplasty, PEA – treated with pulmonary endarterectomy, CON – treated conservatively. Conclusions The survival rate in patients with CTEPH treated with BPA is better than that in patients receiving pharmacotherapy and similar to that in the group of patients subjected PEA., Purpose The aim of the study was to compare long-term outcomes after PAD endovascular revascularization with two types of atherectomy with tip(tAT) (Phoenix® Philips) and side(sAT) (SilverHawk® Medtronic) based excision blades. Methods This was a single center, retrospective registry of obstructive and symptomatic PAD patients who underwent revascularization with atherectomy. The endpoints were considered as target lesion revascularization (TLR), death, amputations and bailout stenting (BS). Results In tAT group was 97 patients, whereas 85 was in sAT group. There were no significant differences between group in baseline characteristics except for increased CLI prevalence in tAT group. The mean follow up was 282.6 ±147.4 and 255.7 ±186.1, sAT and tAT, respectively (p = 0.44). The TLR was more frequent in sAT group than in tAT (sAT: 25 (29.0%) vs. tAT: 15 (15.9%) p = 0.03). There were no significant differences in death (sAT: 1 (1.7%) vs. tAT: 5 (5.7%); p = 0.54), amputations (sAT: 2 (2.3%) vs. tAT: 5 (5.7%); p = 0.45) and bailout stenting (sAT: 2 (2.3%) vs. tAT: 3 (3.2%); p = 0.74). Kaplan-Mayer analysis showed no significant differences between groups in time to TLR, amputation and death (Figure 1). Figure 1 Results Conclusions This study is hypothesis generating that plaque modification with tip based excision blades in directional atherectomy is more efficient than with blades placed on the side of the catheter., Background Concurrent carotid and coronary disease affects an increasing number of patients eligible for surgical coronary revascularization. Assuredly, higher perioperative risk is observed in these individuals. Combined 1-day intervention may reduce the postoperative major cardiac and cerebrovascular events (MACCE) rate; however, bleeding and renal complications can be observed more frequently. Purpose The aim of the study was to asses safety and feasibility of hybrid carotid and coronary revascularization. Methods Retrospective cohort study including 57 consecutive patients (42 males, 15 females; mean age: 70.8 ±6.9 years) with median EuroSCORE II of 2.4% (1.7–3.0) who underwent hybrid one-day carotid and coronary revascularization. Results No 30-day mortality or MACCE were observed and patients were usually discharged on postoperative day 8. Postoperative chest-tube output significantly increased after receiving Clopidogrel (0.2 vs. 0.4 ml/kg/h; p < 0.001). Bleeding events, including re-exploration for bleeding, pleural hematoma, cardiac tamponade, active bleeding (> 1.5 ml/kg/h), massive blood product transfusions (≥ 5 units of PRBC or FFP), and gastrointestinal bleeding occurred in 19.3% of individuals. Platelet count ≤ 110 000 at the cessation of extracorporeal circulation increased the risk of bleeding event (OR = 5.7 (1.39–23.36); p = 0.016). Acute kidney injury was observed in 22.8% of patients and the risk increased with the duration of extracorporeal circulation (OR = 1.41 (1.06–1.88); p = 0.02 for every 10 min). At the median follow-up of 28 (12.5–61) months MACCE occurred with 21.1% rate and was predicted by EuroSCORE II in a Cox-regression model (HR 1.71 (1.11–2.64); p = 0.016). Conclusions Hybrid carotid and coronary revascularization may be performed with acceptable outcome in a specialized cardiac center., Background This prospective study investigated associations between circulating microRNAs (miRNAs) and symptomatic, asymptomatic internal carotid artery stenosis (ICAS), carotid plaque morphology and future cardiovascular events. Methods Circulating miRNAs (miR-1-3p, miR-16-5p, miR-34a-5p, miR-124-3p, miR-133a-3p, miR-133b, miR-134-5p, miR-208b-3p, miR-375 and miR-499-5p) were analyzed in 92 consecutive patients with significant ICAS referred to revascularization. Group I comprised 65 subjects (41 M, age: 69.3 ±9.7 y.o.) with recent cerebral ischemic event (CIE). Group II comprised 27 patients (15 M, age: 68.2 ±8.4 y.o.) with asymptomatic ICAS. The ICAS degree and plaque morphology was assessed by ultrasonography. The incidences of cardiovascular death (CVD), myocardial infarction (MI) and recurrent CIE (CVD/MI/CIE) were recorded prospectively (mean: 38.7 ±3.8 months). Results Group II and group I differed significantly in levels of miR-124-3p (p = 0.036), miR-133a-3p (p = 0.043) and miR-134-5p (p = 0.02). Hypoechogenic, as compared to echogenic plaques differed in levels of miR-124-3p (p = 0.038), miR-34a-5p (p = 0.006), miR-133b (p = 0.048), miR-134-5p (p = 0.045), and miR-375 (p = 0.016), while calcifiedinmiR-16-5p (p = 0.023). Ulcerated plaques showed higher levels of miR-1-3p (p = 0.04) and miR-16-5p (p = 0.003), while thrombotic lower levels of miR-1-3p (p = 0.032). CVD/MI/CIE occurred in 14 (15.5%) out of 90 follow-up patients. Multivariate Cox and ROC analysis showed associations between miR-1-3p and CVD (AUC = 0.634; HR = 4.84; 95% CI: 1.62–14.5; p = 0.005), MI (AUC = 0.743; HR = 7.8; 95% CI: 2.01–30.0; p = 0.003), CVD/MI/CIE (AUC = 0.560; HR = 4.6; 95% CI: 1.61–13.1; p = 0.004), while miR-133b with recurrent CIE (AUC = 0.581; HR = 2.25; 95% CI: 1.01–5.02; p = 0.047). Conclusions The significant difference in levels of selected miRNAs is observed in symptomatic vs. asymptomatic ICAS. Plaque morphology and structure is associated with miRNAs levels change. The expression of miR-1-3p may be potentially prognostic factor for future cardiovascular events., Background Transcatheter aortic valve implantation (TAVI) is an increasingly common treatment of symptomatic severe aortic valve stenosis (AS). Thus, it is reasonable to carefully investigate the impact of individual clinical factors on outcomes after TAVI. Purpose We aimed to investigate the impact of the previous cerebro-vascular events (CVEs) on outcomes of patients with severe AS undergoing TAVI. Methods A total of 148 consecutive patients scheduled for TAVI were included and stratified as with and without a history of CVEs (stroke or transient ischemic attack). Frailty features were also assessed. The primary endpoint was 12-month all-cause mortality. Results Seventeen (11.5%) patients had a history of CVEs (the CVE group). At 30 days and 12 months all-cause mortality was higher in the CVE group (30-day: 5 (29.4%) vs. 7 (5.3%); p = 0.005; 12-month: 9 (52.9%) vs. 13 (9.9%); p = 0.001). Similarly, at the longest available follow-up mortality was higher in the CVE group (10 (58.8%) vs. 23 (17.6%); p = 0.001). Similar rates of other complications after TAVI were noted, apart from in-hospital acute kidney injury (AKI) grade 3 (3 (17.6%) vs. 5 (3.8%); p = 0.049) and blood transfusions (9 (52.9%) vs. 35 (26.7%); p = 0.026). Results of 5MWT and Katz index assessment indicated a greater level of frailty in the CVE group. There were no differences in subsequent events including CVEs, bleeding, myocardial infarction, and new-onset of atrial fibrillation (AF) at 12 months between groups. Conclusions We showed that a history of CVEs in patients with severe AS undergoing TAVI is associated with a higher long-term mortality., Purpose The aim of the study was to characterize morphological variations in the papillary muscles and tendinous cords of the left ventricle and ventricular zones of the mitral valve leaflets. Methods A total of 100 autopsied human hearts from healthy donors with classical mitral valve type were investigated. Results In one heart, only one group of papillary muscles was found, and in the remaining 99%, we could distinguish two groups of muscles: superolateral (SLPM) and inferoseptal papillary muscle (ISPM) groups. The SLPM group had one papillary muscle (75.8%), two in 20.2%, and > three in 4.0%. In the ISPM group, the muscle percentages were 38.4%, 36.4%, and 25.2%, respectively. The apex of at least one papillary muscle was situated higher than the plane of the opened anterior leaflet (AML) in 47.5% and 50.5% for the SLPM and ISPM groups, respectively. The number of strut cords arising from the SLPM group was 0 (2.0%), 1 (50.5%), 2 (33.3%), 3 (12.1%), and 4 (2.0%), and from the ISPM group was 0 (6.1%), 1 (52.5%), 2 (35.4%), or 3 (6.1%). Cords to left ventricular outflow tract were present in 14 specimens. Muscular cords were found in eight hearts. In all hearts specimens AML had rough and clear zones. The classical zones (rough, clear, and basal) in the posterior mitral leaflet were observed in 38.4%. Conclusions There is a high variability in the papillary muscles and tendinous cords in the mitral valve complex. The ventricular surface of AML always has two zones while PML has an inconsistent zone number., Background Treatment of long coronary lesions with bioresorbable scaffolds is currently limited to overlapping implantations only due to the lack of long devices. Additionally, vascular response to long versus regular scaffolds is unknown. Therefore, we compare long vs. regular scaffolds with 100 μm struts (MeRes100) in the porcine coronary restenosis model. Methods and results In total 35 scaffolds, including 23 regular (3.0 × 16 mm) and 12 long (3.0 × 33 mm) were implanted with 120% overstretch with optical coherence tomography (OCT) guidance in 12 domestic animals for 1, 7, 28, 90 and 180 days. At terminal follow-up, terminal imaging with OCT was performed and long scaffolds evaluated in pathology. Stent areas and the neointimal hyperplasia as expressed as % Area Stenosis were comparable at all time points between long and regular scaffolds (Figure 1). Healing and endothelialisation were already complete at 28 days in the long scaffold group. Figure 1 Stent area and % areas stenosis for long and regular scaffolds Conclusions Implantation of long bioresorbable scaffolds was feasible. At mid-term their integrity remained intact and neointimal response comparable to regular size scaffolds, which is contrary to historical data with metallic stents., Background The reduction of heart damage and improvement of patient outcome are the main goals in the treatment of myocardial infarction. For both crucial are the shortening of time to reperfusion and use of appropriate pharmacological treatment. Restrain of myocardial metabolic activity seems to be possible third way, which may have an impact on myocardial damage especially during the critical ischemia. Methods The study is conducted using an animal model. We compare 20 domestic swine (Polish Landrace Pig’s), 10 in the study group (SG) and 10 in the control group (CG). The animals in both groups were randomly paired by age, sex and body mass. Animals in the CG are sequentially given analgesia, sedation and respiratory therapy. After that an arterial access (femoral artery) is obtained, then coronary angiography and POBA LAD (by using balloon catheters (BC) inflation in proximal part of LAD (POBA) (target prox /mid LAD with a diameter of 2.5–4.0 mm behind ostium DG1)) is performed. After 45 min the BC is removed from the LAD. The animal is observed, monitored (if necessary appropriate medication is given). Past 48-hours since POBA the EF assessment (ejection fraction) of LV is performed. Then the subject is euthanized and staining of heart tissue is perforemd with quantitative assessment (computed planimetric assesment) of infarct area (IA) and area at risk (AAR). Similarly in SG the coronary angiography is performed with POBA LAD. After removal of BC from the LAD, a dry puncture of pericardium (pericardial catheter inserted to the pericardial sac) is performed, with subsequent, a 12 h procedure of direct hypothermia of heart (saline 30°C). Forty-eight hours since POBA, the evaluation of EF is made, subject is euthanized, then same staining procedures as in control group performed with quantitative assessment od IA and AAR (Figure 1). Figure 1 Preliminary results in four animals Conclusions Direct heart hypothermia (DHH) method by METcooler in acute experimental heart ischemia is a viable and safe method in an animal model. Dry pericardial puncture and lowering the temperature in the pericardial sac by applying a closed refrigerant circuit are relatively simple procedures that can be performed if necessary in a regular cathlab/cardiology department. Preliminary results demonstrate that the DHH may be considered in the future as an additional method to reduce cardiac damage in the course of myocardial infarction., Relevant history and physical exam 66-year-old Caucasian male patient with congestive heart failure following acute myocardial infarction was hospitalized to undergo cardiac resynchronization therapy (CRT). Past medical history was notable for hypertension, hypercholesterolemia and atrial fibrillation. Relevant test results prior to catheterization Transthoracic echocardiogram demonstrated left ventricle ejection fraction of 29%. Magnetic resonance revealed end-diastolic and end-systolic volume of 272 ml and 197 ml, respectively. An initial 12-lead ECG revealed left ventricle branch block (QRS duration 140 ms) and persistent ST elevation in V3 (3 mm). Relevant catheterization findings PCI of (1) left circumflex artery (LCx) with drug eluting stent implantation (DES), Feb 2016; and (2) left anterior descending artery (LAD) chronic total occlusion (CTO) with DES, Oct 2016. Interventional management Percutaneous catheter-based NOGA (Biosense Webster) electro-mechanical assessment of the left ventricle was performed prior to (Oct 2016) and 10 months after (Aug 2017) LAD CTO intervention. Procedure was performed through right femoral approach with 8 Fr sheath. Reference points were obtained to create a full 3D map. Unipolar (UnP) and bipolar (BiP) potentials as well as regional wall motion (local linear shortening, LLS) data analysis was performed postprocedurally (Figure 1). The periprocedural and hospitalization course was uneventful. Figure 1 Standard NOGA three-dimensional and Bullseye view of the left ventricle – unipolar (UnP), bipolar (BiP) and local linear shortening (LLS). UnP: Purple areas indicate highly viable areas (> 15 mV), red indicates scar tissue (< 5 mV). PiP: purple areas indicate highly viable areas (> 8 mV), red indicates scar tissue (< 1 mV) Case description LAD CTO procedure has improved left ventricle anterior and later wall viability mirrored by increased UnP and BiP segmental voltage values. Presented case illustrates clinical application of the electro-mechanical mapping system as a tool for analysis of myocardial viability and electrical properties in patients undergoing percutaneous coronary artery interventions., Purpose The aim of the study was to establish the clinical utility of urinary biomarkers and peri-procedural variables for the prediction of major adverse cardiac and cerebrovascular events (MACCE) in patients undergoing coronary angiography (CA). Methods In this prospective study 95 consecutive patients with stable and unstable coronary artery disease (69.5% men; median age: 65 (59; 71)) were referred for coronary angiography and followed up for 12 month in order to disclose MACCE defined as onset of cardiovascular death, myocardial infarction, myocardial revascularization or stroke. Urine samples were collected 24-hours before and 6 h following CA and assayed for kidney injury molecule type 1 (KIM-1) interleukin 18 (IL-18), renalase and liver fatty acid-binding protein (L-FABP) using ELISA method and adjusted to urinary creatinine concentration. Results MACCE occurred in 10 (10.5%) patients. Patients with MACCE had higher rate of post-procedural CI-AKI (30.0% vs. 7.1%, p = 0.019), higher median SYNTAX score (25.5 vs. 11.5 points, p = 0.04) and higher post-procedural KIM-1 concentration (0.45 vs. 0.21 ng/mg, p = 0.028), as well as absolute (Δ; 0.41 vs. 0.10 ng/mg, p = 0.013) increase of urinary KIM-1 level. Pre-procedural KIM-1 values and other biomarker values were comparable in both groups. The Kaplan-Meier curve revealed that patients with absolute increase of KIM-1 above 75-percentile (Figure 1; log-rank p = 0.00042) and patients with contrast nephropathy after CA (log-rank p = 0.023) had significantly worse 12-month prognosis. Cox proportional hazards model revealed that absolute ΔKIM-1 was an independent predictor of 12-month MACCE (p = 0.001), while ROC curve analysis revealed that MACCE was accurately predicted by absolute increase of ΔKIM-1 > 0.093 ng/mg (AUC = 0.752, p = 0.0001). Figure 1 Kaplan-Meier survival curve of MACCE occurrence in 12-month observation depending on the increase of post-procedural urinary KIM-1 concentration: ≥ and < 75 percentile MACCE – major adverse cerebral and cardiovascular events, KIM-1 – kidney injury molecule type 1. Conclusions Excessive increase of urinary KIM-1 after CA may help identify patients with impaired 12-month prognosis.

Stimulation of peripheral chemoreceptors by acute hypoxia causes an increase in minute ventilation (VI), heart rate (HR) and arterial blood pressure (BP). However, the contribution of particular chemosensory areas, such as carotid (CB) vs. aortic bodies, to this response in humans remains unknown. We performed a blinded, randomized and placebo-controlled study in 11 conscious patients (nine men, two women) undergoing common carotid artery angiography. Doses of adenosine ranging from 4 to 512 μg or placebo solution of a matching volume were administered in randomized order via a diagnostic catheter located in a common carotid artery. Separately, ventilatory and haemodynamic responses to systemic hypoxia were also assessed. Direct excitation of a CB with intra-arterial adenosine increased VI, systolic BP, mean BP and decreased HR. No responses in these variables were seen after injections of placebo. The magnitude of the ventilatory and haemodynamic responses depended on both the dose of adenosine used and on the level of chemosensitivity as determined by the ventilatory response to hypoxia. Percutaneous radiofrequency ablation of the CB abolished the adenosine evoked respiratory response and partially depressed the cardiovascular response in one participant. The results of the present study confirm the excitatory role of purines in CB physiology in humans and suggest that adenosine may be used for selective stimulation and assessment of CB activity. The trial is registered at ClinicalTrials.gov NCT01939912.

The femoral approach is the most common arterial access for percutaneous coronary artery interventions. Despite the convenience and simplicity of this approach, it is burdened with a high risk of arterial puncture bleeding, which worsens the prognosis of the patient. An alternative approach through the radial artery has been gaining more and more popularity in recent years. This is due to a significant reduction of local bleeding complications as compared with the femoral artery approach. The use of the radial approach in patients with ST-segment elevation myocardial infarction improves outcome, reducing the risk of death, subsequent myocardial infarction and stroke, and is the preferred approach according to the latest ESC guidelines. In addition to improving safety, it is beneficial for improving patient comfort, with a shorter recovery after the procedure, shorter hospitalization and lower medical costs. One of the major complications of procedures performed through the radial approach is radial artery occlusion (RAO). Although it usually has an asymptomatic course, RAO eliminates the ability to use the radial artery as an access in the future. A number of factors that contribute to the occurrence of RAO have been identified, such as the size of the sheath and the catheter, diameter ratio of the sheath to the diameter of the radial artery, insufficient anticoagulation and, above all, the way of obtaining hemostasis at the puncture site: the duration of artery compression after sheath removal and the preservation of artery patency during compression (so-called patent hemostasis). This paper presents the current state of the art about the factors that contribute to the occurrence of RAO and methods for preventing this complication.

Background The utilization of the radial access (RA) for percutaneous coronary intervention (PCI) has gradually increased. Recent studies suggest an advantage over femoral access (FA) in high-risk patients presenting with ST-segment elevation myocardial infarction (STEMI). The aim was to evaluate bleeding complications and periprocedural outcomes with safety and efficacy of RA compared with FA for PCI with stent implantation in “real-world” patients with STEMI presentation from Polish National Registry. Methods The study group consisted of 22,812 consecutive patients with STEMI treated with PCI and stent implantation between January 2014 and June 2015 in 151 tertiary invasive cardiology centers in Poland. All data were stored in electronic database of National PCI Registry (ORPKI). Patients treated with RA and FA were compared using a propensity score analysis to best match between groups. The analysis was done in the “as-treated” manner. Results Femoral access and RA were used in 9,334 (40.9%) and 13,478 (59.1%) patients, respectively. After propensity score matching no differences in baseline characteristic between 6,542 matched pairs was found. Significantly higher total amount of contrast (191.8 ±8 ml vs. 174.8 ±68.8 ml, p = 0.0001) and lower radiation doses were used in FA (1279.5 ±1346.3 mGy vs. 1182.6 ±887 mGy, p = 0.02). More bleeding complications at puncture site after both angiography (0.17% vs. 0.02%; p = 0.004) and PCI (0.23% vs. 0.09%, p = 0.049) were reported in FA group. Periprocedural death (1.94% vs. 0.93%, p = 0.0001) and periprocedural cardiac arrest (1.44% vs. 0.96%, p = 0.01) occurred significantly more often after PCI performed with FA. Conclusions Radial access was associated with lower incidence of periprocedural death in STEMI patients as well as a significant reduction of bleeding complications at access site., Background Little is known on the impact of psoriasis on the outcome of percutaneous cardiovascular procedures. The aim of this analysis was to identify the incidence of active psoriasis, baseline characteristic, and periprocedural to in-hospital outcomes in this subgroup of patients. Methods The Polish National PCI database (ORPKI) is a mandatory registry for all percutaneous cardiology procedures performed in Poland since 2004. All consecutive patients who had coronary angiography or coronary angiography with immediate PCI in 155 interventional cardiology centers in Poland in 2014 for either stable angina or acute coronary syndrome were included. Patients with active psoriasis on admission were identified. Allergic origin of the periprocedural complication was defined if a typical reaction from rash to anaphylaxis was diagnosed. Results There were 206,335 patients with complete records in the database. Active psoriasis was diagnosed in 830 of them (0.4%). Patients with psoriasis were younger (63.1 ±10.6 years vs. 66.2 ±10.9 years, p < 0.01), significantly more often with diabetes mellitus, arterial hypertension and chronic kidney disease. The periprocedural mortality for patients with psoriasis (0.77%) was similar to those without (0.55%; p = 0.6). Interestingly, allergic reaction occurrence during angiography was 0.77% in patients with psoriasis vs. 0.07% in patients without psoriasis (p < 0.001). In multivariate regression analysis, the diagnosis of active psoriasis was an independent predictor of the occurrence of an allergic reaction during coronary angiography/PCI with OR = 8.3 and 95% CI: 1.98–34.93 (p = 0.004). Conclusions Psoriasis is associated with a different patient baseline profile and an increased risk for allergic reaction occurrence during the procedure. Best to our knowledge, this is the first report of such relationship and requires further study., Background Neovascularization in restenotic tissue may play a key role in neointimal proliferation and progression of neoatherosclerosis. There are still insufficient in vivo data regarding in-stent neovascularization. Methods We evaluated 48 stent segments from 24 stents implanted in porcine model of coronary artery injury. Optical coherence tomography (OCT) was performed 90 days post implantation. All measurements and qualitative analysis were performed by two independent investigators. Microvessels were defined as well delineated low backscattering structures with diameter less than 200 microns that show a trajectory within the vessel. There were two groups: with (1) or without (2) occurrence of neovascularization. Optical coherence tomography findings were compared between both groups. Results There were no statistically significant differences between the two groups, but lesions with microvessels had a larger average stent area (8.83 ±1.39 vs. 8.27 ±1.36, p = NS) and larger average neointimal area (2.62 ±1.46 vs. 1.95 ±0.87, p = NS) than those without microvessels. Minimal lumen cross-sectional area (CSA) were almost identical in both groups (2.56 ±0.47 vs. 2.57 ±0.33, p = NS). Conclusions Occurrence of neovascularization might be associated with the extent of neointimal area, but further studies are required to estimate factors associated with strut neovascularization., Background The previous study using intravascular imaging presented that the part of the treated atheroma is squeezed out of the vessel by the stent and its remnants may embolize. The present study aimed to characterize the plaque redistribution with relation to its composition. Methods The combined near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS) imaging analyzed the plaque distribution after the stent implantation in vivo in patients with a stable coronary artery disease (CAD) (n = 33) and acute coronary syndromes (n = 16). Near-infrared spectroscopy detected lipids in the lesion and IVUS presented the redistribution of the plaque. The maximal lipid core burden index in a 4 mm long segment (LCBI4mm) was estimated by NIRS before and after the stent implantation, and IVUS estimated minimal lumen area (MLA), plaque burden (PB) and plaque volume pre and post implantation. Results NIRS-IVUS imaging was performed before and after the implantation of 50 stents in 49 patients. The median plaque volume pre and post implantation was 127.45 (74.5, 186.8) mm2 vs. 99.35 (67.5, 171.5) mm2 (p < 0.001) with a median difference 19.25 (3.9, 72) mm2. The median LCBI4mm pre and post stent was 351 (157, 589) vs. 77 (3, 231) (p < 0.001) in the treated lesions, and 34 (0, 207) vs. 0 (0, 45) (p < 0.04) in segment 4 mm long proximally to the stent. Plaque burden in 4 mm proximally to the implanted stent increased from 46.23 ±11.79 to 50.36 ±9.93 post stenting (p = 0.02). The difference in the plaque volume pre and post stenting correlated with the value of LCBI4max of the treated lesion (r = 0.457, p = 0.001). The median difference in the plaque volume was higher for stented lesions with LCBI 4mm > 265 (8.2 (1.4, 19.3) vs. 24.3 (12.1, 45.0), p = 0.012) (Figure 1). Figure 1 Case example of the combined near-infrared spectroscopy and intravascular ultrasound imaging Conclusions Lipid-rich lesions characterized greater release of the atheroma remnants to the coronary artery lumen as compared to non-lipid rich lesions. The stent implantation causes plaque shift proximally to the implanted stent., Background Adenosine is commonly used to induce maximal hyperemia to evaluate the hemodynamic significance of coronary stenoses with measuring fractional flow reserve (FFR). So far, limited number of studies validated the intracoronary application of adenosine against standard intravenous infusion. Thus, we aimed to assess agreement and reproducibility of FFR measurements during intracoronary vs. intravenous administration of adenosine. Methods Consecutive patients with angiographically borderline coronary lesions (40–90%) diameter stenosis in visual assessment), who were scheduled for FFR were enrolled. Patients received intravenous adenosine infusion via a 6-F femoral venous sheath. Adenosine was administered at 140 at 280 μg/kg/min. Intracoronary adenosine bolus injection was performed with 100 μg, 200 μg, 400 μg and 600 μg. Results Femoral vein adenosine at 140 and 280 μg/ kg/min as well as intracoronary boluses recordings from 81 vessels in 32 patients were suitable for blinded analysis. The median FFR measured using adenosine administered via femoral routes at 140 μg/kg/min was 0.82 (IQR: 0.76–0.89) and at 280 μg/kg/min – 0.82 (IQR: 0.75–0.88), p = 0.001. However, a strong correlation between them was found r = 0.99. Median FFR values for 100 μg, 200 μg, 400 μg and 600 μg bolus were: 0.84, 0.83, 0.83 and 0.83, respectively. We found numerically higher values of FFR assessed with boluses comparing to infusion with the mean difference of FFR from 0.01 (bolus 600 μg) to 0.02 (bolus 100 μg). We did not find any differences between 400 and 600 μg bolus (p = 0.21). Differences between boluses and infusion are shown in details on Figure 1. Figure 1 Mean values of fractional flow reserve assessed with adenosine i.c. boluses and i.v. infusion Conclusions Values of FFR achieved with adenosine infusion via femoral vein and with intracoronary boluses are consistent. However, there seems to be a grey zone for FFR assessed with boluses which may indicate, in selected cases, the use of femoral vein infusion to confirm the results., Background Rotational atherectomy (RA) is often used as a bailout technique after unsuccessful percutaneous coronary intervention (PCI). This study was created to evaluate outcomes of patients undergoing RA depending on reason of previous PCI failure. Methods We retrospectively evaluated data of 210 consecutive patients undergoing RA in our tertiary center. From our analysis we excluded patients undergoing RA without previous PCI attempt (n = 42), those referred from other centers without description of PCI failure cause (n = 10) or lacking complete clinical data (n = 6). Remaining patients (n = 152) were divided into two groups: those with uncrossable (32%) or undilatable lesions (68%). Follow- up data concerning death from any cause was acquired from the Polish National Health Found. Results Patients with uncrossable lesions were older (72 vs. 69 years; p = 0.03) and more often suffered from stroke or transient ischemic attack in anamnesis (20% vs. 8%, p = 0.04). The groups did not differ in any other clinical characteristics. We also did not show any differences in procedure characteristics, success and complications rates or in-hospital adverse events. Patients with uncrossable lesions had higher all-cause mortality after 1 year (18% vs. 8%; p = 0.05), 2 years (24% vs. 10%; p = 0.02) and 3 years (29% vs. 14%; p = 0.03). Multivariate Cox regression model showed uncrossable coronary lesions to be an independent predicting factor of all-cause mortality 2 years after procedure (HR = 2.8; 95% CI: 1.13–7.15; p = 0.03). Conclusions Patients undergoing RA after failed PCI due to uncrossable lesions have poorer long term prognosis. Further studies evaluating causes of higher mortality in this population are needed., Background This study was created to assess the frequency and influence of severe coronary artery calcification (CAC) in target lesions on adverse cardiac events in patients undergoing percutaneous coronary interventions (PCI) due to acute myocardial infarction. Methods We prospectively evaluated data of 206 consecutive patients who underwent PCI due to acute myocardial infarction. The pre-specified angiographic definition of severe calcifications was the presence of radiopaque densities visible without heart motion and affecting both sides of the treated lesion. Follow-up data concerning primary end points was acquired from the Polish National Health Found. Results Severe CAC in target lesions were present in 35 (17%) patients. These patients were older (71 vs. 65 years, p = 0.02), were more often diagnosed with non-ST elevation myocardial infarction (NSTEMI, 77% vs. 58%, p = 0.03) and had higher levels of NT-proBNP at admission (2006 pg/ml vs. 745 pg/ml, p = 0.01). Full revascularization during index procedure was achieved less often in patients with severe CAC (14% vs. 41%, p = 0.003). During 30 months of follow-up patients with severe CAC more often suffered from another ACS (37% vs. 13%, p = 0.0005) and had higher all-cause mortality (31% vs. 16%, p = 0.04). Multivariate Cox regression model showed severe CAC in target lesions to be the only independent predicting factor of another ACS in studied population (hazard ratio = 2.78; 95% confidence interval: 1.39–5.56; p = 0.004). Conclusions In everyday practice, almost every sixth patient with myocardial infarction has severe CAC in target lesions. This group has poorer prognosis then the rest of the population. Presence of severe CAC in target lesions independently predicts recurrent ACS., Background Rotational atherectomy (RA) is s method of treatment of highly calcified lesions that cannot be treated with traditional percutaneous coronary intervention (PCI). However, RA in patients with acute coronary syndromes (ACS) remains controversial and may be contraindicated. Methods The study included 207 consecutive patients, who underwent RA. A retrospective analysis of data in subjects presenting with ACS (n = 42) or treated electively (n = 165) was done. Results Patients presenting with ACS were older, had higher systolic blood pressure and heart rate on admission, they were less likely to undergo PCI before and had lower total left ventricular ejection fraction (LVEF). Estimated risk and lesion complexity were higher in the ACS population. We found no differences in procedural aspects. We noted higher rates of contrast-induced nephropathy and bleeding in the ACS group. During in-hospital observation 2 cases of death occurred in the ACS group, but we found no difference in total mortality, ACS, decompensated HF or stroke rates in 1-year follow-up. Analysis of Cox hazard risk model revealed PCI failure due to uncrossable lesion to be risk factor of total 1-year mortality in the whole studied group; increasing LVEF improved the prognosis. Detailed data are presented in the Table I (see page 396). Table I General characteristics, risk factors and comorbidities Parameter All patients (n = 207) Elective (n = 165) ACS (n = 42) P-value Age, mean ± SD [years] 71 ±2 70 ±1 75 ±4 < 0.001 Previous ACS, n (%) 130 (63) 99 (60) 31 (74) NS Previous PCI, n (%) 152 (74) 128 (78) 24 (57) < 0.01 Previous CABG, n (%) 31 (15) 26 (15) 6 (14) NS Heart failure, n (%) 70 (34) 50 (30) 20 (48) < 0.05 LVEF, mean ± SD [%] 50 ±11 51 ±11 47 ±13 < 0.05 LVEF < 35%, n (%) 34 (17) 22 (14) 12 (29) < 0.05 Procedural data EuroScore II mortality rate, median (IQR) 2.4 (1.4-4.9) 2.1 (1.3-3.8) 5.15 (2.6-9.3) < 0.0001 Syntax Score, median (IQR) 17 (11-24) 17 (11-24) 21.5 (15-29) < 0.05 CABG inoperable, n (%) 116 (56) 86 (52) 30 (41) < 0.05 Attempted PCI failure, n (%): Nondilatable lesion 105 (51) 86 (52) 19 (45) NS Uncrossable lesion 48 (23) 38 (23) 10 (24) NS Unknown 11 (5) 9 (6) 2 (5) NS Procedure success, n (%) 184 (89) 147 (89) 37 (88) NS Ad hoc procedure, n (%) 6 (4) 7 (4) 2 (5) NS Radial access, n (%) 125 (60) 99 (60) 26 (62) NS GP IIb/IIIa inhibitor, n (%) 5 (2) 5 (3) 0 NS IABP n (%) 4 (2) 2 (1) 2 (5) NS Outcomes CIN, n (%) 6 (3) 2 (1) 4 (10) < 0.05 ARC major bleeding, n (%) 14 (7) 8 (5) 6 (14) < 0.05 In-hospital mortality, n (%) 2 (1) 0 2 (5) < 0.05 Inhospital stroke/TIA, n (%) 1 (0.5) 1 (1) 0 NS Inhospital MI, n (%) 28 (14) 22 (13) 6 (14) NS Inhospital TVR, n (%) 1 (0.5) 0 1 (2) NS Total 1-year mortality, n (%) 20 (10) 14 (8) 6 (14) NS 1-year MI, n (%) 20 (8) 15 (9) 5 (12) NS 1-year ADHF n (%) 12 (6) 9 (5) 3 (7) NS 1-year stroke/TIA, n (%) 2 (1) 2 (1) 0 NS Predictors of 1-year mortality (n = 207) Parameter HR 95% CI P-value LVEF (%) 0.95 0.91-0.99 < 0.05 PCI failure: uncrossable lesion 4.00 1.57-10.20 < 0.01 Conclusions One-fifth of RA candidates present with ACS. Despite higher periprocedural mortality rate in ACS group, we found no significant difference in 1-year outcomes in comparison with elective patients. Rotational atherectomy in patients with ACS in experienced centre should be considered in that particular setting if no other options of treatment exist., Background Some patients receiving dual antiplatelet therapy after percutaneous coronary interventions (PCI) with drug-eluting stent (DES) implantation require surgery to be performed during dual antiplatelet therapy (DAPT) administration period. Aim of our research was to assess the risk of premature discontinuation of DAPT after PCI with second generation DES implantation in patients undergoing major vascular surgeries. Methods Our study group consist of 88 patients who underwent PCI with second generation DES implantation between 2010 and 2014 and underwent major vascular surgery up to 12 months after PCI, requiring discontinuation of DAPT in perioperative period. We assessed the frequency of death, myocardial infarction (MI), major bleeding episodes and other adverse events in short and long-term observation. Results Patient characteristics are shown in Table I (see page 397). In perioperative period, we reported no MI, death, or major bleeding. During the follow up period of mean 2.71 (0.16–5.75) years, we recorded 14 (15.9%) deaths: 7 (7.9%) heart related, 4 (4.5%) cancer related, 3 (3.4%) others. In a multivariate analysis, the only independent factor of mortality was left ventricular ejection fraction (LVEF; OR = 0.93; 95 CI: 0.87–0.99; p = 0.02). Time between procedures was not a predictor of mortality and MI. Table I Patient characteristics Variables Values Study group 88 Mean age [years] 69 ±8.3 Sex, male 58 (66%) Mean time between procedures [days] 94.4 ±84.4 Diabetes 31 (35.2%) Mean EF 49.4% Arterial hypertension 73 (83.0%) Atrial fibrillation 8 (9.1%) Recent MI 32 (36.4%) PCI in history 31 (35.2%) CABG in history 9 (10.2%) PAD 67 (76.1%) Stenotic carotid arteries 23 (26.1%) Conclusions In patients with peripheral atherosclerosis requiring major vascular surgery after PCI with second generation DES implantation, early discontinuation of DAPT – on average 90 days after PCI is not associated with increased risk of death, MI, or major bleeding., Background This study aimed to evaluate gender-related differences in short- and long-term outcomes of patients undergoing balloon aortic valvuloplasty (BAV) for severe aortic stenosis (AS). Methods Between October 2012 and July 2015, a cohort of 112 patients with severe aortic AS underwent 114 BAV procedures as palliative procedure, bridge to definitive treatment or before urgent non-cardiac surgery. Clinical and procedural characteristics, in-hospital outcomes and 2-year mortality data were collected. Kaplan- Meier curves for women and men were constructed and compared by the log-rank test. Multivariable Cox regression analysis was performed to identify the independent predictors of long-term mortality. Results Of the 112 patients, 62.5% (n = 70) were women. As compared with men, women were older, had higher STS score, higher prevalence of chronic kidney disease, arterial hypertension and lower aortic valve area (all p < 0.05). Indications for BAV did not differ by gender. Women had higher risk of vascular complications than man (15.7% vs. 0.0%, p = 0.007) however with similar major periprocedural complications rate (17.1% vs. 9.5%, p = 0.40). Transcatheter aortic valve implantation (TAVI) was performed in 22.8% (n = 16) women and 26.2% (n = 11) men, p = 0.61, surgical aortic valve replacement (AVR) in 10% (n = 7) women and 11.9% (n = 5) men, p = 0.70. Women and men treated with TAVI/AVR had lower mortality as compared with conservative treatment (p = 0.004). Peri-procedural, in-hospital and 24- month mortality before definitive treatment were comparable between women and men (2.9% vs. 2.4%, p = 1.00; 11.4% vs. 4.9%, p = 0.26; 63.3% vs. 39.0%, p = 0.22, respectively). Kaplan-Meier curves for survival stratified by gender are shown in Figure 1. In a multivariable Cox model, STS above 9.8 (HR = 2.29; 95% CI: 1.09–4.83, p = 0.028) was an independent predictor of all-cause mortality only in women. Figure 1 Kaplan-Meier curves for survival stratified by gender Conclusions Presence of significant gender-related differences in baseline characteristics, procedural data and risk of vascular complications were confirmed for patients with severe AS undergoing BAV. However, no difference in major procedural complications as well as long-term mortality between women and men was observed., Background Patent foramen ovale (PFO) with occasional right-to-left shunt is associated with an increased risk of decompression illness (DCI). Divers with a history of repetitive or severe DCI and diagnosed PFO should be considered for the percutaneous closure of the defect if they wish to continue with unrestricted diving. In this study we aimed to summarise our experience in transcatheter PFO closure in professional divers with the history of DCI, based on a long-term follow-up of 11 divers treated in our centre. Methods A follow-up of 11 consecutive divers (9 males, 2 females) in whom percutaneous closure of PFO was performed between 2001–2015 for the secondary prevention of DCI was carried out by phone contact (Table I). Table I Characteristics of the investigated group No. Gender Age [years] Observation time [months] Occluder implanted Time from intervention to next diving [days] Number of divings after intervention Max. depth before intervention [m] Max. depth after intervention [m] 1 Male 41 172 APFO 25 5 10,000* 70 160 2 Female 36 121 APFO 25 7 100 110 70 3 Male 35 115 APFO 25 270 300 55 60 4 Male 32 101 APFO 25 180 700 115 120 5 Male 44 99 CARDIA PFO 30 90 800 60 40 6 Female 35 91 APFO 25 365 30 100 70 7 Male 44 60 APFO 25 90 350 75 90 8 Male 40 60 APFO 25 120 150 80 102 9 Male 49 58 APFO 25 30 1,000 140 140 10 Male 30 40 APFO 25 120 150 80 100 11 Male 47 9 APFO 25 180 30 102 80 * Saturation diving technique: total time (hours) from compression to complete decompression. Results The median follow-up at the time of the analysis was 91 (minimum 9, maximum 172) months. No complications of the procedure were observed in the investigated group. All patients returned to unrestricted, deep diving after the procedure, performing a total of 3,610 dives with the median number of 225 dives (lower quartile value: 82.5, upper quartile value: 72.5 dives). The majority of subjects dived as deep as they did before the intervention, or deeper, achieving mean maximum depth of 93.8 ±35.6 m (vs. 89.73 ±25.92 m before the intervention, p = 0.71). No episode of DCI was observed in the follow-up. Conclusions Percutaneous closure of PFO appears reasonably effective in secondary prevention of DCI associated with intra-cardiac shunt., Background In the light of randomized trials, renal artery stenting (PTA) seems to have questionable effect on clinical outcome. However, smaller observational studies indicated that still there might be a field for intervention in the selected subset of subjects. Therefore, the present study aimed to investigate what features distinguish subjects who improved in terms of the systolic blood pressure (SBP) reduction after PTA from those who did not benefit. Methods Study enrolled 118 (57 male, 63.9 ±8.8 years) consecutive patients referred to PTA for ill-controlled hypertension. Blood pressure control was obtained using 24-hour ambulatory blood pressure monitoring (ABPM), with assessment of the mean SBP and diastolic blood pressure (DBP), the loads of SBP and DBP in patients on antihypertensive drugs, before PTA and 12 months after PTA. Study group was divided retrospectively with regard to achieved SBP control. Subjects in whom SBP decreased by at least 20 mm Hg during 12 month FU after PTA were comprised in group I: 25 (21%) patients. Group II comprised 93 (79%) subjects in whom SBP reduction was lower than 20 mm Hg or deteriorated. Results Analysis showed that group I vs. group II patients had higher renal artery stenosis (RAS) degree (75.2 ±14.7% vs. 66.7 ±10.5%, p = 0.001). The initial SBP, DBP, SBP load and DBP load were significantly higher in group I vs. group II subjects (154.8 ±16.7 mm Hg vs. 130.6 ±16.4 mm Hg, p < 0.001; 86.1 ±11.7 mm Hg vs. 72.7 ±8.8 mm Hg, p < 0.001; 77.9 ±18.7 mm Hg vs. 40 ±28.2 mm Hg, p < 0.001, and 50 ±26.4 mm Hg vs. 21 ±18.5 mm Hg, p < 0.001, respectively). The mean number of blood pressure lowering agents was similar in group I and group II subjects, both before (3.44 ±1.3 vs. 3.26 ±1.1, p = 0.479) and 12 months following PTA (3.12 ±1.4 vs. 2.95 ±1.2, p = 0.541). This may indicate that the effect of blood pressure (BP) values decrease was associated rather with PTA, than drug regiments. On backward logistic multivariable analysis, independent predictors of significant blood pressure reduction after the PTA were: higher RAS degree (OR = 1.24, 95% CI: 1.07–1.44; p = 0.006), higher initial SBP (OR = 1.27, 95% CI: 1.03–1.56; p = 0.026), higher initial DBP load (OR = 1.33, 95% CI: 1.09–1.64; p = 0.007) and bilateral RAS or RAS of single functioning kidney (OR = 1.16, 95% CI: 1.00–1.36; p = 0.053). Conclusions Among patients after PTA, about 20% are high responders with regard to blood pressure control. Positive effect following PTA of RAS can be expected in patients with higher initial SBP and DBP parameters, with high-grade RAS and subjects with bilateral RAS or RAS of single functioning kidney. Our results indicate that PTA of RAS is justified in carefully selected patients., Background Studies indicate that patients with renal artery stenosis (RAS) are at high risk of cardiovascular events (CVE), e.g. myocardial infarction (MI), stroke (IS), and cardiovascular death (CVD). However, the impact of renal artery stenting (PTA) in subjects with RAS on the long-term prognosis and factors associated with this unfavourable prognosis are still debated. The present study aimed to evaluate impact of PTA on renal function, blood pressure and survival in patients treated with PTA for RAS, as well as to identify independent risk factors of CVE in long-term follow-up. Methods Two-hundred-and-forty renal artery angioplasty procedures were performed in 208 consecutive subjects (113 male, mean age: 64.5 ±11.9 years) for the mean RAS degree of 70.3 ±13.4% between June 1997 and December 2015. The immediate and long term outcome of PTA was assessed with regard to renal function, blood pressure values and incidence of restenosis. Prevalence of CVE, including CVD, MI, and IS were recorded prospectively. The potential prognostic risk factors of CVD/MI/IS were analyzed. Results The procedural success was 239/240 procedures. Mean creatinine level decreased from pre-PTA: 133 ±62 to 116 ±55.9 µmol/l at 6 month, and to 117 ±58.6 µmol/l at 12 months after PTA (p = 0.003). Systolic blood pressure changed from 142 ±21.8 mm Hg before PTA to 130 ±15.9 mm Hg, at 6 month, and to 130 ±15 mm Hg at 12 month (p < 0.001), while diastolic blood pressure from 78 ±12.3 to 74 ±9.2 mm Hg, and to 73.7 ±9.5 mm Hg (p < 0.001) respectively. The mean number of blood lowering agents was reduced from 3.33 ±1.2 before PTA to 3.06 ±1.3 at 12 month following PTA (p = 0.003). Restenosis occurred in 24/207 (11.6%) patients and it was treated with repeated PTA. Factors associated with restenosis were: hyperlipidemia (OR = 1.23, 95% CI: 1.06–1.42, p = 0.005) and diabetes (OR = 1.15, 95% CI: 1.0–1.33, p = 0.055). During the mean follow-up period of 62.1 ±37 (range: 1–213) months, CVE occurred in 54 (26%) patients (24 CVDs, 17 non-fatal MIs, 13 non-fatal ISs). Initial serum creatinine (OR = 1.25; 95% CI: 1.04–1.51, p = 0.02) and creatinine at 12 month (OR = 1.18; 95% CI: 1.03–1.35, p = 0.015), concomitant coronary artery disease (OR = 1.19; 95% CI: 1.04–1.36, p = 0.011), and SBP at 12 months after PTA (OR = 1.16; 95% CI: 1.02–1.33, p = 0.025) were independently associated with CVD/MI/IS risk. Conclusions PTA of RAS resulted in significant reduction of creatinine level, blood pressure values and the number of blood lowering agents. During mean 5-year period following PTA of RAS, the CVE rate was 26%. Factors independently associated with CVE risk were pre procedural and 12 month levels of serum creatinine, SBP at 12 months following PTA and concomitant coronary artery disease. Restenosis occurred in 11.6% and it was associated with hyperlipidemia and diabetes., Aim To evaluate the role of carotid artery stenting (CAS) performed according to the ‘tailored’ algorithm in the revascularization of severe internal carotid artery (ICA) stenosis in patients requiring (urgent or elective) cardiac surgery. Methods From 2009 to 2015, 100 patients (69.2 ± 6.7 years, range: 53–84 years; 77% male) underwent CAS combined with cardiac surgery: coronary artery bypass grafting (CABG) and/or valve surgery (Table I). The decision on the type and timing of the procedures was made individually in the vascular heart team. Patients with non-ST elevation myocardial infarction (NSTEMI)/unstable angina/NYHA III–IV had a hybrid procedure (HP): CAS simultaneous with cardiac surgery. Those with severe, but stable cardiac disease had staged procedure (SP): CAS in the first step and cardiac surgery ≥ 5 weeks later. Carotid artery stenting was done according to the ‘tailored’ strategy – to fit proper neuroprotection (proximal or distal) and stent type (open, closed-cell or mesh-covered) to the ICA stenosis severity and neurological symptoms. In the HP group CAS was performed on acetylsalicylic acid and unfractionated heparin; loading dose of clopidogrel (300 mg) was given in ≥ 6th postoperative hour, if major bleedings were excluded. Patients in SP group had dual antiplatelet therapy for a month, clopidogrel was withdrawn 5–7 days before cardiac surgery. Table I Patient and procedure characteristics Parameter HP (N = 58) SP (N = 42) P-value Age [years] 70.2 ±6.6, range: 53-83 67.9 ±6.8, range: 55-84 0.09 Ipsilateral stroke/TIA 17 (29%) 22 (52%) 0.13 ICA stenosis (%) 85.3 ±9.7; 60-99 85.3 ±8.1; 60-99 1.0 Proximal neuroprotection device 28 (48.3%) 21 (50%) 1.0 Closed-cell/mesh-covered stent 55 (95%) 37 (88%) 0.88 Left main stenosis 21 (36%) 12 (28.6%) 1.0 EuroSCORE II 2.74 ±1.39; 0.95-6.91 1.98 ±1.08; 0.85-4.95 0.004 Isolated CABG 52 (89.6%) 36 (86%) 0.88 Isolated valve surgery or CABG + other procedure* 6 (10.3%) 6 (12.5%) 0.75 * Valve/aortic surgery/left ventricle aneurysmectomy/ left atrial appendage closure. Results No major neurological in hospital or 30-day complications were noted. In the early postoperative period 1 myocardial infarction and 2 deaths as a result of multi-organ failure (3; 5.2%) occurred in the HP group and 1 (2.4%) death due to cardiogenic shock in SP group; p = 0.6. Conclusions Carotid artery stenting performed according to the ‘tailored’ algorithm prior to cardiac surgery is a low risk procedure and might be an option to prevent possible perioperative neurological complications of ICA stenosis. Patients requiring urgent cardiac surgery have slightly increased risk of the procedure., Background About 30% of patients with carotid artery stenosis (CAS) develop dementia after cerebral ischemic event (CIE), and 20–50% suffer from CIE recurrence during 6 months. Carotid artery revascularization (CAR) may prevent CIE recurrence, at the cost of new micro-embolic lesions (MES). The impact of CAR on cognitive function is debatable. The aim was to assess either functional and cognitive outcome, cerebral flow on transcranial Doppler (TCD) and brain magnetic resonance imaging (MRI) in patients with symptomatic CAS referred to CAR. Methods Fifteen patients (aged 68 ±8.2 years old, 9 male) with recent CIE (17.6 ±10.2 days to CAR) related to CAS of mean 88.9 ±3.9% lumen reduction were prospectively with TCD, diffusion and perfusion MRI, Montreal Cognitive Assessment (MoCA), Mini Mental State Examination (MMSE), modified Rankin Scale (mRs) and National Institutes of Health Stroke Scale (NIHSS) 24 h before, at 48–72 h and 1 month following CAR. Results New MES were found in 7 (46.7%) subjects following CAR. Carotid artery revascularization resulted in significant increase of cerebral flow velocity in middle and anterior cerebral arteries (p < 0.001 and p = 0.009; respectively) and cerebral perfusion measured by TTP and MTT (p = 0.005 and p = 0.002; respectively). Neurologic tests showed improvement in NIHSS (3.1 ±1.1 to 1.9 ±1.2; p = 0.003), mRs (from 1.6 ±0.8 to 0.9 ±0.9, p = 0.008), and MMSE (26.4 ±2.4 to 27.8 ±2.3; p = 0.012) at 1 month. Montreal Cognitive Assessment scores before and 1 month after CAR remained similar (22.8 ±3.6 vs. 23.4 ±3.3; p = 0.752). Conclusions Improvement of cerebral flow and perfusion, functional outcome, as well as no cognitive decline are observed after CAR for symptomatic CAS., Background Very early discharge after percutaneous coronary interventions (PCI) is now possible vascular closure devices (VCDs) when using the femoral access. Methods We retrospectively analyzed 261 consecutive procedures performed from femoral access with a VCD in a single center between January 2008 and December 2013. The primary endpoint was access site complication rate. The secondary endpoint was time from end of procedure to discharge. Results The complication rate was 2.68% (7/261). The following complications occurred: 3 hematomas, 1 pseudoaneurysm requiring treatment and 3 device failures. Mean time to discharge was 4 h 1 min (range: 2 h 19 min to 6 h 48 min). Conclusions Utilization of VCDs allows for safe and early same-day discharge of patients undergoing planned PCI procedures., Background Previous studies of same-day discharge after percutaneous coronary intervention (PCI) demonstrated favorable short term outcomes. There are limited data evaluated the long term results, especially for unselected population. Methods We retrospectively studied and followed up for 12 months 396 consecutive patients undergoing planned PCI with same-day discharge between December 2007 and May 2015 in two stand-alone centers. Results The mean age of the study population was 56.6 ±7.59 years (males 77.22%). 10.1% of the lesions were on bifurcation, 4.29% were CTO, 5.3% were in a bypass graft and 1.26% were in protected LM. Procedural success occurred in 96.21%. Groin access was used in 83.08% with VCD in 93.01% of procedures. Access site complications (uncomplicated VCD failure, hematoma, small dissection, pseudoaneurysm, spasms of radial) occurred in 1.77% of cases. Only 1 patient required hospitalization due to anaphylactic drug reaction in a peri-procedural period. The mean time from procedure end to discharge was 3 h 59 min. No death or major bleeding occurred during 30-day observation. Two patients had early stent thrombosis with MI, 1 patient was re-admitted for repeat angiography without intervention, 1 had TVR and one patient had stroke. At 12 months there were 15 ISR required angioplasty or CABG and 28 TVR. One patient had stroke and one had transient ischemic attack. Seven patients had MI at 12 months (1.77%). One patient died due to non-cardiac reasons. Conclusions Our study shows excellent long term safety outcomes for unselected population of patients undergoing elective PCI in stand-alone centers without overnight stay., Background We aimed to evaluate safety and efficacy of hemostatic polyurethane matrix (Hematrix) for femoral artery access site closure. Methods and results In a series of 31 patients two sizes of Hematrix patch were used: 10 × 10 cm (body mass index > 30 kg/m2 or thick layer of fat at puncture site) or 5 × 5 cm. The arterial sheath (6 F in all cases) was removed directly after the procedure and then the access site was manually compressed for 10 min. In patients who had PCI (and heparin administered) a compression band was placed for 6 h. In the remaining cases no compression band was used, and the access site was checked for hematoma or bleeding during the first 6 h. Hemostasis was obtained in all patients. The blood flow in femoral artery (evaluated by ultrasound examination) was normal in all cases. Only one serious complication was seen – a pseudoaneurysm of femoral artery access site – probably due to administration of low molecular weight heparin 48 h after the procedure. Two cases of mild complications (6% of the group) were seen: superficial hematomas that required prolonged compression by pressure band. Conclusions The Hematrix patch appears to be efficient in closing femoral artery access site after cornarography or PCI. It offers similar advantages and has equally low incidence of complications as currently available mechanical closure devices (sheath removed directly after the procedure, short bed rest or compression time). It is distinguished from them by much lower price and requires less training.

BACKGROUND: Among patients with stable coronary disease and moderate or severe ischemia, whether clinical outcomes are better in those who receive an invasive intervention plus medical therapy than in those who receive medical therapy alone is uncertain. METHODS: We randomly assigned 5179 patients with moderate or severe ischemia to an initial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed. The primary outcome was a composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. A key secondary outcome was death from cardiovascular causes or myocardial infarction. RESULTS: Over a median of 3.2 years, 318 primary outcome events occurred in the invasive-strategy group and 352 occurred in the conservative-strategy group. At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, -1.8 percentage points; 95% CI, -4.7 to 1.0). Results were similar with respect to the key secondary outcome. The incidence of the primary outcome was sensitive to the definition of myocardial infarction; a secondary analysis yielded more procedural myocardial infarctions of uncertain clinical importance. There were 145 deaths in the invasive-strategy group and 144 deaths in the conservative-strategy group (hazard ratio, 1.05; 95% CI, 0.83 to 1.32). CONCLUSIONS: Among patients with stable coronary disease and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of ischemic cardiovascular events or death from any cause over a median of 3.2 years. The trial findings were sensitive to the definition of myocardial infarction that was used. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.).