Multicenter registry of Impella-assisted high-risk percutaneous coronary interventions and cardiogenic shock in Poland (IMPELLA-PL).

BACKGROUND: Impella is a percutaneous mechanical circulatory support device for treatment of cardiogenic shock (CS) and high-risk percutaneous coronary interventions (HR-PCIs). IMPELLA-PL is a national retrospective registry of Impella-treated CS and HR-PCI patients in 20 Polish interventional cardiological centers, conducted from January 2014 until December 2021. AIMS: We aimed to determine the efficacy and safety of Impella using real-world data from IMPELLA-PL and compare these with other registries. METHODS: IMPELLA-PL data were analyzed to determine primary endpoints: in-hospital mortality and rates of mortality and major adverse cardiovascular and cerebrovascular events (MACCE) at 12 months post-discharge. RESULTS: Of 308 patients, 18% had CS and 82% underwent HR-PCI. In-hospital mortality rates were 76.4% and 8.3% in the CS and HR-PCI groups, respectively. The 12-month mortality rates were 80.0% and 18.2%, and post-discharge MACCE rates were 9.1% and 22.5%, respectively. Any access site bleeding occurred in 30.9% of CS patients and 14.6% of HR-PCI patients, limb ischemia in 12.7% and 2.4%, and hemolysis in 10.9% and 1.6%, respectively. CONCLUSIONS: Impella is safe and effective during HR-PCIs, in accordance with previous registry analyses. The risk profile and mortality in CS patients were higher than in other registries, and the potential benefits of Impella in CS require investigation.

Double-blind, placebo-controlled evaluation of biorest liposomal alendronate in diabetic patients undergoing PCI: The BLADE-PCI trial.

BACKGROUND: Diabetes mellitus (DM) is an important predictor of neointimal hyperplasia (NIH) and adverse clinical outcomes after percutaneous coronary intervention (PCI). LABR-312, a novel intravenous formulation of liposomal alendronate, has been shown in animal models to decrease NIH at vascular injury sites and around stent struts. The aim of the Biorest Liposomal Alendronate Administration for Diabetic Patients Undergoing Drug-Eluting Stent Percutaneous Coronary Intervention trial was to assess the safety, effectiveness, and dose response of LABR-312 administered intravenously at the time of PCI withDES in reducing NIH as measured by optical coherence tomography postprocedure in patients with DM. METHODS: Patients with DM were randomized to a bolus infusion of LABR-312 vs placebo at the time of PCI. Dose escalation of LABR-312 in the study arm was given: 0.01 mg, 0.03 mg, and 0.08 mg. The primary endpoint was the in-stent %NIH volume at 9 months as measured by optical coherence tomography. RESULTS: From September 2016 to December 2017, 271 patients with DM undergoing PCI were enrolled; 136 patients were randomized to LABR-312 infusion and 135 patients were randomized to placebo. At 9-month follow-up, no difference was seen in the primary endpoint of %NIH between LABR-312 and placebo (13.3% ± 9.2 vs 14.6% ± 8.5, P = .35). No differences were present with the varying LABR-312 doses. Clinical outcomes at 9 months were similar between groups. CONCLUSIONS: Among patients with DM undergoing PCI with drug-eluting stents, a bolus of LABR-312 injected systematically at the time of intervention did not result in a lower rate in-stent %NIH volume at 9-month follow-up.

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

BACKGROUND: Despite primary PCI (PPCI), ST-elevation myocardial infarction (STEMI) can still result in large infarct size (IS). New technology with rapid intravascular cooling showed positive signals for reduction in IS in anterior STEMI. AIMS: We investigated the effectiveness and safety of rapid systemic intravascular hypothermia as an adjunct to PPCI in conscious patients, with anterior STEMI, without cardiac arrest. METHODS: Hypothermia was induced using the ZOLL® Proteus™ intravascular cooling system. After randomisation of 111 patients, 58 to hypothermia and 53 to control groups, the study was prematurely discontinued by the sponsor due to inconsistent patient logistics between the groups resulting in significantly longer total ischaemic delay in the hypothermia group (232 vs 188 minutes; p<0.001). RESULTS: There were no differences in angiographic features and PPCI result between the groups. Intravascular temperature at wire crossing was 33.3+0.9°C. Infarct size/left ventricular (IS/LV) mass by cardiac magnetic resonance (CMR) at day 4-6 was 21.3% in the hypothermia group and 20.0% in the control group (p=0.540). Major adverse cardiac events at 30 days increased non-significantly in the hypothermia group (8.6% vs 1.9%; p=0.117) while cardiogenic shock (10.3% vs 0%; p=0.028) and paroxysmal atrial fibrillation (43.1% vs 3.8%; p<0.001) were significantly more frequent in the hypothermia group. CONCLUSIONS: The ZOLL Proteus intravascular cooling system reduced temperature to 33.3°C before PPCI in patients with anterior STEMI. Due to inconsistent patient logistics between the groups, this hypothermia protocol resulted in a longer ischaemic delay, did not reduce IS/LV mass and was associated with increased adverse events.

A head-to-head comparison of wall motion score index, force, strain, and ejection fraction for the prediction of SYNTAX and Gensini coronary scores by dobutamine stress echocardiography.

BACKGROUND: Predicting the severity of coronary artery disease (CAD) may be possible during dobutamine stress echocardiography (DSE) with various indices of left ventricular function. AIMS: We assessed the relative value of ejection fraction (EF), force, global longitudinal strain (GLS), and wall motion score index (WMSI) in predicting SYNTAX and Gensini scores in patients with known or suspected CAD. METHODS: We prospectively enrolled 223 patients (120 men; mean [SD] age, 62 [9] years) and assessed the following indices: 1) EF (with triplane imaging); 2) force, calculated as the ratio of systolic blood pressure to left ventricular end­systolic volume; 3) GLS; 4) WMSI. All patients underwent coronary angiography within 12 weeks with SYNTAX and Gensini scores evaluation. RESULTS: The correlation of SYNTAX and Gensini scores was highest with peak WMSI (SYNTAX, rho = 0.591; Gensini, rho = 0.612; P <0.001), intermediate with peak force (SYNTAX, rho = -0.346; Gensini, rho = -0.377; P <0.001) and GLS (SYNTAX, rho = -0.205; P = 0.002 and Gensini rho = -0.216; P = 0.001), and the weakest for EF (SYNTAX, rho = -0.149; P = 0.03 and Gensini, rho = -0.191; P = 0.006). The similar hierarchy of variables was detected for changes during DSE. In the subgroup after myocardial infarction (n = 66 [27%]), GLS outperformed the force. CONCLUSIONS: In patients with CAD at DSE peak, theWMSI and force were better predictors of the coronary SYNTAX and Gensini scores and CAD severity than GLS or EF. However, in patients after myocardial infarction, the GLS correlation with coronary scores improved and got closer to the visual assessment.

Resistant hypertension: Renal denervation or pharmacovigilance? Insights from a renal denervation screening program.

BACKGROUND: With emerging new therapeutic concepts including renal denervation (RDN), there is a renewed interest in resistant hypertension (ResH). Among patients suspected of having ResH, a definitive diagnosis needs to be established. OBJECTIVES: This study presents observations from a standardized single-center screening program for RDN candidates, including medical therapy modification and reassessment. MATERIAL AND METHODS: All patients referred to our center for RDN underwent a standardized screening protocol. Candidates were recruited from among patients receiving no less than 3 antihypertensive drugs, including diuretics with office blood pressure (BP) >140/90 mm Hg. The assessment included 2 measurements of BP and ambulatory BP monitoring (ABPM). If needed, pharmacotherapy was intensified and the diagnosis of ResH was reconfirmed after 6 weeks. If ResH was persistent, patients were hospitalized with repeated ABPM on day 4. Further, renal CT-angio was performed and a multidisciplinary team discussed the patients' suitability for RDN. RESULTS: A total of 87 patients with a ResH diagnosis were referred for RDN. Mean office BP was 159/92 (±7.0/6.5) mm Hg and mean ABPM was 154/90 (±9.0/4.8) mm Hg. The initial medication included angiotensin convertase inhibitors (ACE-I, 78%), angiotensin receptor blockers (12%), ß-blockers (85%), calcium channel blockers (36%), and diuretics (93%). During the 18 months of the RDN program, 5 patients underwent RDN and 2 further had ineligible renal anatomy. A new diagnosis of secondary hypertension was made in 21 patients. However, in 59 patients, BP control was achieved after optimization of medical therapy, with a mean ABPM of 124/74 mm Hg. The final treatment included ACE-I (100%), ß-blockers (92%), indapamide (94%), amlodipine (72%), and spironolactone (61%). Medication in most of these patients (88%) included single-pill triple combination (52.5%) or double combination (35.6%). CONCLUSIONS: Patients with elevated BP screened for RDN require a rigorous diagnostic workup. Up to 2/3 of patients can be managed with strict pharmacotherapy compliance and pharmaceutical intensification, including single-pill combinations and improved drug compliance. Hasty use of RDN may be a result of poor drug optimization and/or compliance. It does remain a viable treatment option in thoroughly vetted ResH patients.

Prevalence of hepatitis C virus infection in patients hospitalised for ischemic heart disease versus controls - PRO-CARDIO-C study.

AIM OF THE STUDY: Ongoing national screening programmes suggest that the prevalence of chronic hepatitis C (CHC) in Poland ranges between 0.5% and 1%. It has been recently noted that patients with confirmed coronary artery disease may be at higher risk for hepatitis C virus (HCV) infection. MATERIAL AND METHODS: Testing for the presence of anti-HCV antibodies was performed in a group of patients admitted to the Cardiology Department with symptomatic ischemic heart disease (IHD) and in patients hospitalised in the Dermatology Department. RESULTS: A total of 1171 patients underwent anti-HCV testing: 672 patients in the Cardiology Department (K group) and 499 patients in the Dermatology Department (D group). Twenty-eight (2.4%) positive anti-HCV results were detected. The prevalence of positive anti-HCV antibodies in groups K and D was 2.23% and 2.61%, respectively (p > 0.05). Presence of HCV RNA was confirmed in 15 cases (1.28%) - 7 patients in group K and 8 patients in group D (1.04% and 1.6%, respectively; p > 0.05). CONCLUSIONS: Our findings suggest that this patient cohort has increased risk of HCV infection, which may influence screening strategies.

Relative value of serum pregnancy-associated plasma protein A (PAPP-A) and GRACE score for a 1-year prognostication: A complement to calculation in patients with suspected acute coronary syndrome.

BACKGROUND: The Global Registry of Acute Coronary Events (GRACE) study produced a scale for risk stratification in acute coronary syndromes (ACSs). Pregnancy-associated plasma protein A (PAPP-A) serum concentration was implicated as a marker of unstable atherosclerotic plaques. OBJECTIVES: We hypothesized that the measurement of the concentration of PAPP-A on admission may improve the stratification of cardiovascular risk in suspected ACS patients. MATERIAL AND METHODS: We studied 70 patients with chest pain suggesting ACS diagnosis on admission. Serum cardiac biomarkers and PAPP-A were measured on top of the standard biochemical panel, and the GRACE risk score was calculated. A 12-month follow-up was completed to major adverse cardiac events (MACE): death, myocardial infarction (MI), need for percutaneous coronary intervention (PCI)/coronary artery bypass grafting (CABG), unplanned cardiovascular hospitalization. RESULTS: In hospital/6-month GRACE, low risk was found in 35 patients (50%)/37 patients (53%), intermediate risk in 23 patients (33%)/21 patients (30%) and high risk in 12 patients (17%)/12 patients (17%). Mean PAPP-A was 39.64 mlU/L (standard deviation - SD 24.2), and median PAPP-A values for in hospital/6-month GRACE were 21.49 mlU/L (quartile 1st; 3rd - 13.41; 32.65) and 22.61 mlU/L (14.03; 34.1) for low risk patients, 51.76 mlU/L (35.18; 59.99) and 51.76 mlU/L (28.9; 62.1) for intermediate risk patients, and 68.82 mlU/L (58.54; 83.76) for high risk patients. The PAAP-A concentration with specific cut-off points had 66.7% positive predictive value (PPV) and 95.5% negative predictive value (NPV) for death, 33.3% PPV and 80.6% NPV for MI, 71.4% PPV and 57.1% NPV for any event. Intermediate and high in hospital/6-months GRACE had 14.3%/15.2% PPV and 100%/100% NPV for death, 34.3%/33.3% PPV and 94.3%/91.9% NPV for MI, 74.3%/72.7% PPV and 65.7%/62.2% NPV for any event. CONCLUSIONS: The PAPP-A serum concentration represents a promising prognostic biomarker with significantly improved PPV. The GRACE score is superior to stratification based on PAPP-A with regard to combined cut-off point for 1-year mortality.

Conscious sedation for transcatheter implantation of atrial septal occluders with two- and three-dimensional transoesophageal echocardiography guidance - a feasibility and safety study.

BACKGROUND: General anaesthesia may have negative impact on patient mortality and morbidity, as well as overall procedure costs, in atrial septal occluder (ASO) implantation. AIM: We sought to evaluate the safety, efficacy, and feasibility of conscious sedation for transcatheter implantation of ASOs. METHODS: A total of 122 patients referred for transcatheter implantation of ASO were included. Mean patient age was 51 ± 15 years, and 43 (35%) patients were male. The initial dose of midazolam was 2 mg and fentanyl dose was 25 µg. Additional doses of midazolam and fentanyl were administered, if necessary. Patient responsiveness was assessed every 10 min, and the sedatives doses were titrated in order not to exceed grade 3 sedation in the Ramsey scale. RESULTS: Atrial septal occluders were successfully implanted in the majority of patients (98.4%). In two (1.6%) cases the proce-dure failed because of too small patent foramen ovale (PFO) diameter (n = 1, 0.8%) or device instability (n = 1, 0.8%). The mean duration of procedure was 47.6 ± 28.4 min and was similar for ASD and PFO closure (p = 0.522). The overall mean dose of midazolam was 4.7 ± 2.2 mg (63.9 ± 32.5 µg/kg) and fentanyl was 30.0 ± 11.9 µg (0.43 ± 0.17 µg/kg). Median entrance dose of radiation at the patient plane was 25 (interquartile range: 16-57) mGy, and did not differ between ASD and PFO procedures (p = 0.614). The majority of patients were free of complications (91.0%). The following early complications were observed: transient ischaemic attack (n = 2, 1.6%), supraventricular arrhythmias (n = 4, 3.3%), left atrial thrombus formation (n = 1, 0.8%), symptomatic bradycardia (n = 1, 0.8%), and femoral venous bleeding (n = 5, 4.1%). After mean follow-up of 386 days residual shunt was observed in eight (6.6%) patients. CONCLUSIONS: Conscious sedation for transcatheter implantation of ASO is a feasible, safe, and efficient technique, allowing successful PFO and ASD closure in the majority of patients.

The role of selected adipokines and ghrelin in the prognosis after myocardial infarction in a 12-month follow-up in the presence of metabolic syndrome.

INTRODUCTION: The aim of this study was to evaluate the predictive value of selected adipokines in the improvement in the ejection fraction and in the development of adverse cardiac remodeling during 12 months of follow-up among patients with an ST-segment elevation acute myocardial infarction (STEMI) in the presence of metabolic syndrome (MeS). MATERIAL AND METHODS: The study population consisted of 69 patients (49 male; mean age: 59 ±10 years) with a first STEMI that was treated with a primary percutaneous coronary intervention (pPCI). In this group, 36 patients (18 male; mean age: 60 ±15 years) had MeS according to the definition of the International Diabetes Federation. The baseline clinical evaluation included a clinical examination and evaluation of the blood levels of C-reactive protein, ghrelin, resistin, and fasting glucose. Within 72 h after the STEMI, an echocardiographic examination was performed. A complete clinical evaluation was repeated after 12 months. Adverse cardiac remodeling was defined as an increase in the left ventricular end-diastolic volume of ≥ 8%. An improvement of the ejection fraction (EF) was defined as an increase of more than 5% in the EF. RESULTS: A concentration of ghrelin ≤ 160.46 pg/ml (AUC = 0.71, p = 0.032) had a good predictive value for the occurrence of adverse left ventricular remodeling but only in the patients without MeS. Among the patients with MeS, a concentration of resistin ≤ 5196 pg/ml (AUC = 0.073, p = 0.024) had a good predictive value for the occurrence of left ventricular remodeling. A concentration of leptin > 52.18 pg/ml (AUC = 0.81, p < 0.0001) and resistin > 4419.27 ng/ml (AUC = 0.67, p = 0.049) had a good predictive value for improvement of the LVEF in the patients without MeS. CONCLUSIONS: The selected adipokines had a good predictive value for the development of adverse cardiac remodeling and for improvement of the ejection fraction among patients after a STEMI in the presence of metabolic syndrome.

COOL AMI EU pilot trial: a multicentre, prospective, randomised controlled trial to assess cooling as an adjunctive therapy to percutaneous intervention in patients with acute myocardial infarction.

AIMS: We aimed to investigate the rapid induction of therapeutic hypothermia using the ZOLL Proteus Intravascular Temperature Management System in patients with anterior ST-elevation myocardial infarction (STEMI) without cardiac arrest. METHODS AND RESULTS: A total of 50 patients were randomised; 22 patients (88%; 95% confidence interval [CI]: 69-97%) in the hypothermia group and 23 patients (92%; 95% CI: 74-99) in the control group completed cardiac magnetic resonance imaging at four to six days and 30-day follow-up. Intravascular temperature at coronary guidewire crossing after 20.5 minutes of endovascular cooling decreased to 33.6°C (range 31.9-35.5°C). There was a 17-minute (95% CI: 4.6-29.8 min) cooling-related delay to reperfusion. In "per protocol" analysis, median infarct size/left ventricular mass was 16.7% in the hypothermia group versus 23.8% in the control group (absolute reduction 7.1%, relative reduction 30%; p=0.31) and median left ventricular ejection fraction (LVEF) was 42% in the hypothermia group and 40% in the control group (absolute reduction 2.4%, relative reduction 6%; p=0.36). Except for self-terminating paroxysmal atrial fibrillation (32% versus 8%; p=0.074), there was no excess of adverse events in the hypothermia group. CONCLUSIONS: We rapidly and safely cooled patients with anterior STEMI to 33.6°C at the time of coronary guidewire crossing. This is ≥1.1°C lower than in previous cooling studies. Except for self-terminating atrial fibrillation, there was no excess of adverse events and no clinically important cooling-related delay to reperfusion. A statistically non-significant numerical 7.1% absolute and 30% relative reduction in infarct size warrants a pivotal trial powered for efficacy.

Comparison of shortened gated myocardial perfusion imaging processed with "Myovation Evolution" with full time study.

BACKGROUND: The work compares the results of shortened gated myocardial perfusion imaging (MPI), processed with "Myovation Evolution" software, with a study performed in a standard way. MATERIAL AND METHODS: A retrospective study was conducted in a group of 95 patients (56 males and 39 females, age 62 ± 9 years, BMI 28 ± 4) with known or suspected CAD, without clinical history or any signs of a previous myocardial infarction. All patients underwent coronary angiography (CA) within 3 months of MPI. CA was used as a reference for diagnostic performance of MPI. Patients underwent a stress/rest 2-day MPI. Both studies were performed twice, with normal (25s) and shortened (13s) time per projection. Studies were processed using Myovation protocol (OSEM with 2 iterations and 10 subsets) for full time (FT) studies and a Myovation Evolution protocol dedicated to half time (HT) studies (OSEM with 12 iterations, 10 subsets). Reconstructed images, with and without attenuation correction (AC), were evaluated by 2 experienced nuclear medicine specialists (a consensus), with regard to image quality and perfusion, evaluated using a visual semi-quantitative method, applying a standard division of myocardium into 17 segments. Perfusion was assessed in every segment using a standard 5 grade scale. Summed stress scores were calculated for every patient and threshold values for detection of CAD were selected based on ROC analysis with CA treated as a reference method. After 2 months FT images were interpreted again by the same specialists. RESULTS: The quality of images obtained from shortened and normal studies was equally good. All correlation coefficients between segmental scorings of FT and HT studies were high and statistically significant. Correlation coefficients between corresponding segments in FTAC and HTAC (i.e. with AC) studies were systematically higher than without AC. The agreement between FT and HT study results was equal to 81% for FT and HT studies and to 86% for FTAC and HTAC studies (p = 0.40). The repeatability of FTAC study assessments was equal to 94%. 95-percent confidence intervals calculated for agreement between FTAC and HTAC studies and the repeatability of FTAC study overlapped considerably. Correlation coefficients for EDV, ESV and EF values between FT and HT were high: 0.93, 0.96 and 0.88, respectively. CONCLUSION: Myovation Evolution protocol used for reconstruction of myocardial perfusion studies with reduced number of counts requires AC. The agreement between the results of visual assessment of normal and reduced count studies is high and not worse than the agreement between repeat assessment of a full time study.