Paweł Balsam

Cost-effectiveness of radial vs. femoral approach in primary percutaneous coronary intervention in STEMI – Randomized, control trial

INTRODUCTION AND OBJECTIVES Primary percutaneous coronary intervention infarction became the preferred method of treatment for myocardial ST segment elevation. Improved safety was reported in transradial access (radial) compared to transfemoral access (femoral). The aim of this study was to compare the cost between the two access points in ST segment elevation myocardial infarction. METHODS This is a subanalysis of the OCEAN RACE trial in which 103 myocardial infarction patients were randomized to either the radial (n=52) or femoral (n=51) groups. The clinical safety and efficacy were recorded during the hospital stay. The procedural metrics were meticulously logged, and costs were evaluated using the micro-cost method. The indirect costs were estimated using the human capital approach. RESULTS Clinical success was numerically higher in the radial group (90.4 vs. 80.4%, p=0.123). There were no differences in major adverse cardiac events (9.6% vs. 11.8%, p=0.48) and death (2.0% vs. 6.0%, p=0.31). The average in-hospital cost per patient was 2,740 ± 1,092 EUR. The cost of therapeutic success was lower in the radial group at 3,060 EUR vs. 3,374 EUR. The indirect costs related to absence at work were 138 EUR per patient, which were lower in the radial group compared to the femoral group. CONCLUSIONS The total in-hospital costs were similar between the study groups. The indirect costs were lower in the radial group. Introduction of radial access as the default approach in all centers may significantly reduce the overall financial burden from a social perspective.

Influence of beta-blockers on endothelial function: A meta-analysis of randomized controlled trials

BACKGROUND Endothelial dysfunction (ED) frequently precedes cardiovascular diseases (CVD) and is a well-established risk factor of major adverse cardiac events. Beta-blockers are the fundamental drugs used in CVD treatment. METHODS A systematic literature search for randomized controlled trials investigating influence of beta-blockers on endothelial function assessed by flow-mediated dilation (FMD) was performed in the PubMed and Cochrane Databases. RESULTS Sixteen full-text studies involving a total of 1,273 patients were included in the final analysis. The mean age of participating patients ranged from 44.9 to 63.2 years, the follow-up duration from 1 to 12 months. The comparison of FMD change between the beta-blockers and placebo groups showed a statistically significant effect of beta-blockers on endothelial function (mean difference [MD] 0.83; 95% confidence interval [CI] 0.11-1.55; p = 0.02). Third generation beta-blockers improved FMD in a statistically significant manner compared with second generation beta-blockers (MD 1.65; 95% CI 0.17-3.11; p = 0.03). Beta-blockers gave an FMD change similar to that obtained with angiotensin receptor blockers (ARB), calcium channel blockers (CCB) or hydrochlorothiazide. The FMD value in the beta-blocker group was significantly lower compared with the group treated with angiotensin converting enzyme inhibitors (ACEI) (MD -0.79; 95% CI -1.37-(-0.21); p = 0.008) and higher than in the ivabradine group (1.6 ± 3.61 vs -0.3 ± 1.66; p = 0.02). CONCLUSIONS Beta-blockers improve the endothelial function compared with placebo. More-over, third generation beta-blockers improve FMD values significantly better than the second generation ones. Beta-blockers had similar effect on endothelial function as did ARB, CCB or diuretics. However, the beneficial effect of beta-blockers was lower when confronted with ACEI.

Does a blanking period after pulmonary vein isolation impact long-term results? Results after 55 months of follow-up.

BACKGROUND The aims of the study are 1) to assess antiarrhythmic prophylaxis efficacy during the first 2 months after radiofrequency ablation (ARF) due to AF; 2) to define risk factors for early AF recurrence (EAFR) after ARF; 3) to determine the long-term follow-up results and risk factors for late AF recurrence (LAFR). METHODS A total number of 210 consecutive patients who had undergone ARF due to AF were analyzed. Patients were randomized into three groups: Group 1 (G1), without any anti-arrhythmic drug (AAD); Group 2 (G2), with amiodarone or sotalol; Group 3 (G3), with last ineffective AAD. The study was designed to analyze two periods: short-term observation, the first 2 months after ARF; and at least 2 years of long-term follow-up. RESULTS After 2 months, clinical data were collected from 171 patients (123 males, mean age of 50.3 years; persistent AF in 19.8%; lone AF in 36.6%). Sinus rhythm (SR) was maintained in 84 (49.1%) patients; 35 (20.4%) patients presented with a single episode of AF, 39 (23%) patients experienced a reduction in number of AF episodes, and 13 (7.5%) patients showed no improvement. No predisposing factor for early recurrence was found. After a mean follow-up of 55 months, clinical data were collected in 137 patients, of which 47 (34%) maintained SR. Those more likely to sustain SR were: males (82.9% vs. 62.2%; p = 0.018), younger patients (44.8 ± 12.7 vs. 52.5 ± 9.9; p = 0.0001), patients with smaller left atrium diameter (4.05 ± ± 0.49 cm vs. 4.25 ± 0.51 cm; p = 0.04), and those without any AF recurrence during the first 2 months after ARF (78.7% vs. 35.6%; p < 0.0001). In the multivariable analysis, the independent risk factors for LAFR were hypertension (p < 0.001) and persistent AF (p = 0.014). CONCLUSIONS Antiarrhythmic prophylaxis does not affect the number of AF recurrences during the first 2 months after ablation. SR maintenance during a blanking period after AF ablation is a positive prognostic factor in long-term follow-up. Persistent AF and hypertension are independent risk factors for late AF recurrence after pulmonary vein isolation.

Clinical characteristics and predictors of one-year outcome of heart failure patients with atrial fibrillation compared to heart failure patients in sinus rhythm

BACKGROUND Atrial fibrillation (AF) frequently coexists with heart failure (HF). AIM To assess clinical characteristics and to identify predictors of one-year outcome of patients hospitalised for HF, depending on whether they were in sinus rhythm (SR) or had AF. METHODS The study included Polish patients hospitalised for HF, participating in the Heart Failure Pilot Survey of the European Society of Cardiology, who were followed for 12 months after discharge. Patients with paced heart rhythm were excluded from the study. The primary endpoint was all-cause death at 12 months. RESULTS The final analysis included 587 patients. AF occurred in 215 (36.6%) patients. Compared to patients in SR, patients with AF were older, more often had a history of previous HF hospitalisation, were characterised by a higher New York Heart Association (NYHA) class, higher heart rate, and lower diastolic blood pressure at hospital admission, and had higher serum creatinine and lower haemoglobin concentration at admission. In-hospital mortality was higher in AF patients compared to SR patients (5.1% vs. 2.4%, respectively), but the difference did not reach statistical significance (p = 0.1). The primary endpoint occurred in 41 of 215 AF patients (19.1%) and in 40 of 372 SR patients (10.8%; p = 0.006). In a multivariate analysis, predictors of the primary endpoint in AF patients were: higher NYHA class at hospital admission (p = 0.02), higher admission heart rate (p = 0.04), lower admission serum sodium concentration (p = 0.0001), and higher heart rate at discharge (p = 0.01). In patients with SR, independent predictors of the primary endpoint included: older age (p = 0.007), lower serum sodium concentration at admission (p = 0.0006), and higher heart rate at discharge (p = 0.008). CONCLUSIONS Patients with HF and concomitant AF differ significantly from HF patients in SR. In the studied group of real-world HF patients, serum sodium concentration at hospital admission and heart rate at hospital discharge were independent prognostic factors in patients with AF and in patients in SR. In contrast to SR patients, heart rate at hospital admission in AF patients was also predictive of long-term mortality.

Patients with heart failure and concomitant chronic obstructive pulmonary disease participating in the Heart Failure Pilot Survey (ESC-HF Pilot) – Polish population

Introduction There is an increasing interest in comorbidities in heart failure patients. Data about chronic obstructive pulmonary disease (COPD) in the Polish population of heart failure (HF) patients are scarce. The aim of this study was to investigate the clinical characteristics, treatment differences and outcome according to COPD occurrence in the Polish population of patients participating in the ESC-HF Pilot Survey Registry. Material and methods We analyzed the data of 891 patients with HF recruited in 2009–2011 in Poland: 648 (72.7%) hospitalized patients and 243 (27.3%) patients included as outpatients. Results The COPD was documented in 110 (12.3%) patients with HF in the analyzed population. Patients with – compared to those without COPD were older, more often smokers, had higher NYHA class, and higher prevalence of hypertension. Ejection fraction (EF) was higher in hospitalized patients with COPD compared to patients without COPD (40.5 ±14.6% vs. 37.2 ±13.7%, p < 0.04), without a significant difference in the outpatient group. There was a significant difference in β-blocker use between patients with and without COPD (81.8% vs. 94.7%, p < 0.0001). Most patients received them below target doses. At the end of the 12-month follow-up, there was no significant difference in mortality between COPD and no-COPD patients (10.9% vs. 11.1%, p = 0.66). Conclusions The findings from the Polish part of the ESC-HF registry indicate that COPD in patients with HF is associated with older age, smoker status, hypertension and higher NYHA class. The use of β-blockers was significantly lower in patients with than without COPD. There were no significant differences in mortality between groups.

2017 ISHNE-HRS expert consensus statement on ambulatory ECG and external cardiac monitoring/telemetry

Ambulatory ECG (AECG) is very commonly employed in a variety of clinical contexts to detect cardiac arrhythmias and/or arrhythmia patterns which are not readily obtained from the standard ECG. Accurate and timely characterization of arrhythmias is crucial to direct therapies that can have an important impact on diagnosis, prognosis or patient symptom status. The rhythm information derived from the large variety of AECG recording systems can often lead to appropriate and patient‐specific medical and interventional management. The details in this document provide background and framework from which to apply AECG techniques in clinical practice, as well as clinical research.

Predictors of one-year outcome in patients hospitalised for heart failure: results from the Polish part of the Heart Failure Pilot Survey of the European Society of Cardiology.

BACKGROUND Over the last few decades, the incidence and prevalence of chronic heart failure (HF) have been constantly increasing. AIM To identify predictors of one-year mortality and hospital readmissions in patients discharged after hospitalisation for HF. METHODS The study included Polish patients who agreed to participate in the Heart Failure Pilot Survey of the European Society of Cardiology and were followed for 12 months. The primary endpoint was all-cause death at 12 months. The secondary endpoint was a composite of all-cause death and readmission for cardiac causes at 12 months. RESULTS The final analysis included 629 patients. The primary end point occurred in 68 of 629 patients (10.8%). In multivariate analysis, independent predictors of one-year mortality were: higher New York Heart Association (NYHA) class at admission (odds ratio [OR] 1.90; 95% confidence interval [CI] 1.01-3.59; p = 0.0478), inotropic support during hospitalisation (OR 3.95; 95% CI 1.49-10.47; p = 0.0056), and lower glomerular filtration rate at discharge (OR 0.978; 95% CI 0.961-0.995; p = 0.0117). The secondary endpoint occurred in 278 of 503 patients (55.3%). In multivariate analysis, predictors of secondary endpoint were a history of previous coronary revascularisation (OR 2.403; 95% CI 1.221-4.701; p = 0.002) and inotropic support during hospitalisation (OR 2.521; 95% CI 1.062-5.651; p = 0.009). CONCLUSIONS Patients discharged after hospitalisation for HF remained at high risk of death and hospital readmission. A previous history of coronary revascularisation, decreased renal function, and worse clinical status at admission with the need for inotropic support were predictors of one-year outcome in Polish patients hospitalised for HF.

Evaluation of endothelial function and arterial stiffness in HIV-infected patients: a pilot study.

BACKGROUND In the era of combination antiretroviral therapy (cART), life expectancy of HIV-infected patients is the same as that of the general population, resulting in increasing prevalence of cardiovascular disease in this patient group. AIM To assess the prevalence of endothelial dysfunction in HIV-infected patients and to identify factors which affect endothelial function and arterial stiffness. METHODS Thirty-seven adult HIV-infected patients, regardless of the fact and the type of cART, were enrolled into the study. In patient, reactive hyperaemia peripheral arterial tonometry assessment was performed using the Endo-PAT2000 device (ITAMAR®). This method allows evaluation of endothelial function ant arterial stiffness. RESULTS Final analysis included 37 patients (median age 38 years, range 32-45 years), including 89.2% men. Endothelial dysfunction was found in 13 (35.1%) HIV-infected patients. We found no differences in demographic and clinical characteristics, laboratory data, and cardiovascular drug therapy between patients with or without endothelial dysfunction, except for platelet count which was higher in patients with endothelial dysfunction (174 [119-193] × 10³/mm3 vs. 222 [168-266] × 10³/mm³, p = 0.03). No demographic or clinical variables were identified as predictors of endothelial dysfunction in HIV-infected patients. In addition, no association was found between factors related to HIV infection, chronic drug therapy and the risk of endothelial dysfunction. Statistically significant correlations were found between arterial stiffness and age (rs = 0.53, p < 0.001), red blood cell count (rs = -0.39, p = 0.018), and platelet count (rs = 0.42, p = 0.009). CD4+ and CD8+ lymphocyte count and viral load were similar in patients with or without endothelial dysfunction. Arterial stiffness was significantly higher in patients with higher viral load (rs = -0.39, p = 0.0018) and in those with established AIDS (9.5 [1.0-16.0] vs. -5 [-10-5], p = 0.009). cART had no effect on endothelial dysfunction, while arterial stiffness was higher in patients treated with cART (10 [0-15] vs. -5 [-10-3], p = 0.014). CONCLUSIONS Endothelial dysfunction is common in HIV-infected patients. In general, none of the analysed factors had an effect on endothelial function but cART had a negative effect on arterial stiffness.

Antazoline for termination of atrial fibrillation during the procedure of pulmonary veins isolation

PURPOSE Pulmonary vein isolation is a well established method of definite treatment of atrial fibrillation (AF). Periprocedural onset of AF usually terminates spontaneously within minutes, but not in all cases. Antazoline is an antihistaminic agent with antiarrhythmic properties. The aim of our retrospective study was to evaluate the efficacy of antazoline in termination of AF in patients undergoing pulmonary vein isolation. MATERIALS AND METHODS Consecutive 141 patients who received antazoline to terminate AF during pulmonary vein isolation were analyzed. The antazoline was administered at the rate of 30-50mg/min (max. 500mg) after the circumferential ablation in the ostia of pulmonary veins and before confirmation of isolation. Success was defined as restoration of sinus rhythm within 20min after antazoline infusion. RESULTS The efficacy of antazoline was 83.6% in paroxysmal and 31.1% in persistent AF patients. Clinical variables that were independently predictive of antazoline ineffectiveness were female (odds ratio [OR]: 4.35; 95% confidence interval [CI]: 1.26-14.3; p=0.018) and AF at the beginning of procedure (OR 28.4; 95% CI 3.89-208.0; p=0.001). Due to antazoline related side effects infusion was discontinued in 7 patients (5%). CONCLUSIONS Antazoline seems to be safe agent in termination of AF in patients undergoing pulmonary vein isolation. We also observed satisfying efficacy, which needs to be proved in a randomized clinical trial.

The effect of cycle ergometer exercise training on improvement of exercise capacity in patients after myocardial infarction

BACKGROUND Cardiac rehabilitation in patients after myocardial infarction (MI) is a component of secondary prevention that has an established role in the current guidelines. AIM To determine the effect of physical training on exercise capacity parameters determined on the basis of cardiopulmonary exercise test (CPET) in patients after MI. We also evaluated the relationship between the number of training sessions and exercise capacity. METHODS We prospectively evaluated 52 patients after MI who underwent percutaneous coronary intervention of the infarct-related artery. At the start of the training, patients had no symptoms of heart failure and coronary artery disease. Electrocardiographic exercise test was performed 4 to 6 weeks after MI, followed by CPET in patients with a negative stress test. After determination of the initial exercise capacity, patients underwent 12 training sessions on a cycle ergometer with a workload determined on the basis of anaerobic threshold or heart rate reserve. After 12 training sessions, CPET was performed, followed by another 12 training sessions and a follow-up CPET. RESULTS All patients showed a significant increase in exercise capacity parameters: energy expenditure during CPET increased from 9.39 to 11.79 METs, peak oxygen uptake (VO₂peak) increased from 32.32 to 39.25 mL/kg/min (p < 0.001), and oxygen uptake at the anaerobic threshold increased from 18.34 to 24.65 mL/kg min (p < 0.001). The initial 12 training sessions resulted in a statistically significant increase in VO₂peak from 32.32 to 36.75 mL/kg/min (p = 0.003), while subsequent 12 training sessions were related with an insignificant increase in VO₂peak from 36.75 to 39.25 mL/kg/min (p = 0.065). CONCLUSIONS Regular physical activity improves exercise capacity as measured by CPET. A statistically significant improvement in exercise capacity was seen already after initial 12 training sessions, while another 12 training sessions were associated with smaller benefits.