Sodium Zirconium Cyclosilicate in HFrEF and Hyperkalemia: REALIZE-K Design and Baseline Characteristics.

BACKGROUND: Mineralocorticoid receptor antagonists (MRAs) improve outcomes in patients with heart failure and reduced ejection fraction (HFrEF). However, MRAs are often underused because of hyperkalemia concerns. OBJECTIVES: The purpose of this study was to assess whether sodium zirconium cyclosilicate (SZC), a nonabsorbed crystal that traps and rapidly lowers potassium, enables MRA use in patients with HFrEF and prevalent hyperkalemia (or at high risk). METHODS: REALIZE-K is a prospective, double-blind, placebo-controlled trial in patients with HFrEF (NYHA functional class II-IV; left ventricular ejection fraction ≤40%), optimal therapy (except MRA), and prevalent hyperkalemia (or at high risk). During the open-label run-in, all participants underwent protocol-mandated spironolactone titration (target: 50 mg daily); those with prevalent (cohort 1) or incident (cohort 2) hyperkalemia during titration started SZC. Participants achieving normokalemia while on spironolactone ≥25 mg daily were randomized to continuing SZC or matching placebo for 6 months. The primary composite endpoint was proportion of participants with optimal response (normokalemia, on spironolactone ≥25 mg daily, no rescue for hyperkalemia [months 1-6]). RESULTS: Of 365 patients (run-in), 202 were randomized. Baseline characteristics included mean age 70 years, prevalent comorbidities (78% estimated glomerular filtration rate <60 mL/min/1.73 m2, 38% atrial fibrillation/flutter), high N-terminal pro B-type natriuretic peptide (median 1,136 pg/mL), and high HFrEF therapy use (64% sacubitril/valsartan, 96% beta-blocker, 42% sodium glucose co-transporter 2 inhibitor). At randomization, 78% were receiving spironolactone 50 mg daily. CONCLUSIONS: REALIZE-K is the first trial to evaluate whether SZC can enable rapid and safe MRA optimization and long-term continuation in patients with HFrEF and prevalent/high risk of hyperkalemia. (Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients with Symptomatic HFrEF Receiving Spironolactone; NCT04676646).

Systemic Brucellosis with Arrhythmogenic Cardiac Inflammatory Pseudotumor.

BACKGROUND Cardiac inflammatory pseudotumors are rarely observed. Their etiology might include immunologic abnormalities, fibrogenetic disorders, specific reactions to infections or abnormalities related to trauma, necrosis, or neoplasm. Life-threatening ventricular tachycardia and cases of sudden death related to cardiac tumors have been reported. The present report describes and discusses diagnostic and therapeutic solutions for the treatment of nonsarcoid multiorgan pseudotumors with cardiac involvement. CASE REPORT A 38-year-old woman presented to the clinic with symptomatic ventricular tachycardia. As coronary artery disease, cardiomyopathy, and channelopathy were ruled out, and electrocardiograms were not typical of idiopathic arrhythmia, the patient underwent detailed diagnostics which included targeted endomyocardial biopsy, which revealed a cardiac inflammatory pseudotumor. Laborious testing (and eventually, antibiotic therapy) led to ex juvantibus diagnosis of multiorgan disseminated brucellosis with cardiac involvement. Treatment with ceftriaxone, doxycycline, and rifampicin resulted in a complete resolution of all lesions after 3 months, and sustained recovery was observed during a 5-year follow-up. As the risk of ventricular tachycardia could not be reliably predicted, the patient had a subcutaneous implantable cardioverter-defibrillator implanted. CONCLUSIONS A vast diagnostic armamentarium of modern medicine allowed us to diagnose an unsuspected and rare cardiac inflammatory pseudotumor. In the case of travelers, the possibility of regionally specific illnesses, especially infections, must be taken into consideration as possible causes of arrhythmias. Cardiac magnetic resonance imaging may be useful in patients with 'idiopathic ventricular tachycardias' to detect non-apparent myocardial lesions which may result from the underlying cause of the arrhythmia.

Clinical valuation of ST changes in a group of patients with ventricular arrhythmias: The inSighT Study.

BACKGROUND: The inSighT study was designed to determine the prevalence of ischemic changes as recorded by implantable cardioverter-defibrillator (ICD) ST deviations in intracardiac electrocardiograms (EGM) over the 24 h preceding malignant ventricular arrhythmias (VT/VF). METHODS: The study enrolled patients with known coronary artery disease (CAD) or high risk of future development of CAD implanted with an ICD equipped with an ST monitoring feature (Ellipse™/Fortify Assura™, St. Jude Medical). Device session records were collected at each in-clinic follow-up. EGM ST levels of the beats over the 15 minutes prior to VT/VF events were compared using a t test with those from a baseline period of 23-24 h prior to the VT/VF event. All events with p < .05 were visually inspected to confirm they were evaluable; additional criteria for exclusion from further analysis included inappropriate therapy, aberrant conduction, and occurrence of VT/VF within 24h prior to the current event. RESULTS: The study enrolled 481 ICD patients (64 ± 11 years, 83% male) in 14 countries and followed them for 15±5 months. A total of 165 confirmed VT/VF episodes were observed, of which 71 events (in 56 patients, 34% of all patients with VT/VF) were preceded by significant (p < .05) ST-segment changes unrelated to known non-ischemic causes. None of the analyzed demographic and clinical factors proved to be associated with greater odds of presenting with ST-segment changes prior to VT/VF episode. CONCLUSION: In this exploratory study, characteristic ST-segment changes, likely representative of ischemic events, were observed in 34% of all patients with VT/VF episodes.

The safety, efficacy, and cost-effectiveness of gentamycin-collagen sponge in multicomponent prevention strategy of cardiac implantable electronic device infections - a single-center experience.

BACKGROUND: Cardiac implantable electronic device(CIED)infections are associated with significant morbidity, mortality, and increased healthcare expenses. Apart from standard systemic antibiotic therapy, locally acting agents are under investigation as a potential approach for the prevention of this complication. AIMS: The study aimed to summarize our experience with a gentamycin-collagen sponge (GCS) in a multi-component prevention strategy of cardiac implantable electronic device infection. METHODS: We retrospectively analyzed medical records of 312 consecutive patients who underwent CIED-related surgery and had at least a 6-month follow-up. All the individuals had GCS applied during surgery. An incidence of CIEDs-related infection in our group was compared to the risk level calculated according to the commonly used scores. Analysis of cost-effectiveness was also performed. RESULTS: Incidence of CIED-related infection, defined as a primary endpoint, occurred relatively rarely (0.33%) as compared to the infection risk calculated according to commonly used scores Prevention of Arrythmia Device Infection Trial (PADIT) - 0.83%; CIED-AI - 0.90% or Mittal score - 1.00%; P<0.001 - for all). We did not record any complications related to GCS. We analyzed the cost-effectiveness of our GCS-based approach, which appeared to be financially beneficial (number needed to treat 149-200; difference of CIED infection treatment cost and GCSs price was 5093-26525 $). CONCLUSIONS: We conclude that: (1) the use of GCS to reduce CIEDs infections is feasible and safe; (2) our multicomponent prevention strategy involving the GCS application seems to significantly reduce the rate of CIED infection, and it is cost-effective.

Multicentre early experience with totally subcutaneous cardioverter-defibrillators in Poland.

INTRODUCTION: Implantable cardioverter-defibrillators (ICD) have a strong position in the prevention of sudden death. Nowadays, the most commonly used high-energy cardiac devices are transvenous ICDs. A new technology of totally subcutaneous ICDs (S-ICD) was invented and recently introduced into clinical practice in order to reduce lead-related complications of conventional ICDs. The aim of this paper is to present early experience with this new technology implemented in a few centres in Poland. MATERIAL AND METHODS: Medical records of patients who had S-ICD-related interventions in Poland were retrospectively analysed. RESULTS: During the first year of S-ICD introduction into the Polish health system 18 patients underwent surgery connected with S-ICDs. Majority of them (17 patients) were implanted de novo. In one patient surgical revision of a device implanted abroad was performed. Most of patients (78%) had S-ICDs implanted for secondary prevention. Inability of transvenous system implantation due to venous access obstruction or high risk of infection related with transvenous leads accounted for 83% of indications for S-ICD. Only in three patients were S-ICDs implanted due to young age and active mode of life. The implantations of S-ICDs were performed without important early or late complications. During follow-up one patient had episodes of ventricular arrhythmia successfully terminated with high-energy shocks. One patient died due to progression of heart failure. CONCLUSIONS: S-ICD implantation procedure has been successfully and safely introduced in Polish clinical routine. Nevertheless, despite clear indications in recent ESC guidelines, this therapy is not directly reimbursed in Poland and needs individual application for refund.

Conventional and alternative preimplantation ECG screening for subcutaneous ICD in high risk hypertrophic cardiomyopathy patients.

INTRODUCTION: Patients with hypertrophic cardiomyopathy (HCM) relatively often fail preimplantation ECG screening for subcutaneous implantable cardioverter-defibrillator (S-ICD). We aimed to evaluate impact of conventional and alternative ECG electrodes placement on eligibility for S-ICD implantation in HCM patients at high risk of sudden cardiac death (SCD). We hypothesized that modified electrodes placement will influence QRS-T morphology and thus it will increase S-ICD eligibility in the screening process. MATERIAL AND METHODS: This study enrolled 17 HCM patients at high risk of SCD (5-year SCD risk above 5%) referred for an ICD implantation. ECG screening for S-ICD eligibility in horizontal and vertical position was performed in each patient, in two different screening electrodes configuration: conventional (recommended by manufacturer) and alternative (precordial electrodes shifted rightwards and lateral electrodes dorsally). We evaluated QRS and T waves amplitude as well as T wave index. Primary, secondary and alternate sensing vectors were assessed. RESULTS: Preimplantation ECG screening with alternative electrodes placement resulted in more sensing vectors that were screened successfully (77 vs. 88, p = 0.05). Modified screening combined with a standard one allowed more patients to qualify for S-ICD implantation (17/17 vs. 12/17, p = 0.04). Electrocardiographically, the alternative positioning of ECG electrodes resulted in significant decrease in absolute values of QRS complex and T waves amplitudes in almost all sensing vectors, which was responsible for successful screening. CONCLUSIONS: The use of alternative placement of screening electrodes may be a valuable method to increase eligibility for S-ICD implantation in HCM patients at high risk of SCD.

[Long-term prognosis in patients with vasovagal syncope after pacemaker implantation]. / Rokowanie odlegle u pacjentów z omdleniami wazowagalnymi po implantacji kardiostymulatora.

Patients with syncope, without presence of a structural or primary electrical disease, have a very good prognosis. On the other hand, recurring syncope has a negative impact on quality of life and involves a real risk of physical injuries. Vasovagal syncope usually requires no medical therapy and the most commonly recommended instruction include avoidance of fainting triggers, exercise that mainly provoke leg muscles tension, increase salt consumption and drink indicated amount of fluids. In the case cardioinhibitory type of vasovagal syncope the pacemaker implantation can consider. Unfortunately, not all patients benefit from this treatment. Medical society clearly highlights that proper qualification of VVS patients is the most important factor for cardiostimulator implantation. This article aims to summarize the most important research and guidelines concerning cardiac pacing for patients with vasovagal syncope.

[Technical options of electrotherapy in patients with vasovagal syncope]. / Techniczne mozliwosci elektroterapii u osób z omdleniami wazowagalnymi.

Syncope is a symptom of the disease with diverse etiology and can be evidence of both benign and very serious life-threatening conditions. Vasovagal syncope(VVS), with prevalence about 35% of the general population, is most frequent causes of transient loss of consciousness (T-LOC). Most cases of vasovagal syncope requires conservative treatment. Although cardioinhibitory type of VVS characterized by a significant bradycardia or pause of the heart rate and can be treated with continuous electrotherapy. This article discuss cardiac pacing and technical solutions for the treatment of VVS. Available cardiac pacing methods used to detect and break VVS such as Rate Drop Response (RDR), Closed Loop Stimulation (CLS) and rate response driven by variations of myocardial contractility like Peak Endocardial Acceleration (PEA), has been presented.

Work-related risk factors of myocardial infarction.

OBJECTIVES: The aim of the study was to find out which occupational factors account for the risk of the myocardial infarction. MATERIAL AND METHODS: A questionnaire survey was performed during the period of one calendar year in all patients (1053 subjects, 692 men and 361 women) hospitalized at the Medical University of Lódz because of the first myocardial infarction. The questionnaire was prepared especially for the purpose of this study and consisted of two parts. The first part comprised: demographic data, health status at admittance, traditional risk factors for the ischaemic heart disease and was filled-in by physicians. Part II was done by occupational hygiene specialists and referred to education, job title and characteristics, employment data, self assessment of work-related and general stress, fatigue, socio-economic status, physical activity, alcohol intake, tobacco smoking, dietary habits. RESULTS: Mean age in the study group was 59.9 ± 10.4 years (26-85 years), 58.7 ± 10.0 (26-84 years) for men and 62.3 ± 10.7 (32-85 years) for women, employment duration was 32.9±8.8 (4-65 years), for men 34.0 ± 8.6 (5-65 years), for women 30.7 ± 8.8 (4-60 years. Most of myocardial infarction cases both in the group of men and women were noted in the age interval 56-60 years, 22.3% vs. 17.4%, respectively. The majority of examined men were farmers, low and middle management and self-employed workers. Among women prevailed clerks, seamstresses and farmers. The most frequent occupational risk factors were: work-related stress, experienced by 54.2% of the examined subjects, occupational noise (45,5%), dust (41,7%) and various chemical factors (33%). A majority of the study group (76.5% women and 54.4% men) linked the cardiac infarction with stress, while 39.1% men vs. 16.5% women correlated it with physical effort. CONCLUSION: Our studies indicate that, among a wide spectrum of occupational factors, stress, noise and fine particulate dust are major contributors to the increased risk of myocardial infarction.

Bifocal pacing in the right ventricle: an alternative to resynchronization when left ventricular access is not possible in end-stage heart failure patients.

BACKGROUND: It has been reported that bifocal pacing (BiF) in the right ventricle might be an alternative to unsuccessful left ventricular lead implantation. This case report presents an assessment of the clinical and hemodynamic parameters during a three month follow-up in patients implanted with right ventricular BiF. METHODS: Eight patients who underwent unsuccessful left ventricular lead implantation were implanted with a bifocal system in the right ventricular. Leads were implanted in the right atrium appendage, the apex and the right ventricular outflow tract and connected to the cardiac resynchronization therapy pacemaker. All patients performed a sixminute walking test and underwent echocardiography after the implantation and after the three month follow-up. RESULTS: We found a significant performance increase in the six minute walking test and reduction in New York Heart Association class and mitral regurgitation in echocardiography study, as well as a significant increase in left ventricular ejection fraction, and cardiac output directly after the implantation, as well as at threemonth follow-up in patients after BiF implantation. CONCLUSIONS: Right ventricular bifocal pacing in patients with cardiac resynchronization therapy indication and unsuccessful left ventricular lead placement seems to be a beneficial treatment for heart failure. Satisfactory hemodynamic and clinical results were observed directly after BiF implantation and during the three month follow-up.

[Physiological significance of estrogens in men--breakthrough in endocrinology]. / Znaczenie fizjologiczne estrogenów u mezczyzn--przelom w endokrynologii.

Estradiol (E2) is traditionally recognised as the female sex hormone. It has been believed for 40 years, that E2 didn't exert any influence or caused impairment of the gonadal function in men. The main source of E2 in men is adipose tissue and the brain. E2 is also produced in adrenals, liver, mammary glands, hair and in male gonad. Daily production and the level of E2 in the blood in men are higher than those in postmenopausal women. At the end of the 80-ties we were first reporting that during sexual maturation E2 can be the important hormonal signal for the initiation of spermatogenesis. The traditional view about unimportant or inhibitory role of E2 in male physiology was finally refuted thanks to discovering estrogen receptors in males. In the 90-ties, transgenic mice with the lack of estrogen receptor (ER) or gene encoding enzyme aromatase, that enable the conversion of testosterone into E2, were also produced. Observations of men with inherited mutations of these genes, considerably extended our knowledge about E2 in men in stroma bones formation, inhibition of their growing, lipids metabolism and sexual maturation, the effects that were attributed to testosterone action until today. New data also points at important role of estrogens and ER in the function of the cardio-vascular system and in counteracting coronary disease in men.

[Important functions of estrogens in men--breakthrough in contemporary medicine]. / Wazne funkcje estrogenów u mezczyzn--przelom we wspóczesnej medycynie.

Estradiol (E2) is traditionally recognised as the female sex hormone. Since discovery of estrogens in the early forties of XX century it has been believed, that these hormones caused impairment of the gonadal function in men or didn't exert any influence. New studies are contradictory, but indicate also a possible involvement of estrogens in the pathogenesis of some systemic diseases of men. The main source of E2 in men is adipose tissue and the brain. E2 is also produced in adrenals, liver, mammary glands, hair and in male gonads. Daily production and blood level of E2 in men are higher than those in postmenopausal women. In 1988 we were the first to demonstrate that E2 is an important hormonal signal for initiation of spermatogenesis. The traditional view about unimportant or inhibitory role of E2 in male physiology was finally refuted thanks to discovery of the estrogen receptors in males. In the middle 90ties transgenic mice with the lack of estrogen receptor (ER knockout) or enzyme aromatase, that enable the conversion of testosterone into E2, were produced. Observations of men with inherited mutations of these genes, considerably extended our knowledge about stimulatory role of E2 in men in the formation of bone stroma, inhibition of their linear growth, lipids metabolism and sexual maturation, the effects that were attributed to testosterone action until today. New data indicate role of estrogens and ER in the function of the cardio-vascular system. Their link with development of arteriosclerosis seems, however, to be bipolar. In single reported cases of men with the inactivating mutations of ERalpha or aromatase genes, a precocious arteriosclerosis is noted. From the other site, men homozygous for the most common variant of ERalpha gene (ESR1c.454-397cc) have a significantly increased risk of myocardial infraction. Estrogens are the risk factors in prostatic cancer and their local tissue increase in autoimmune diseases is connected with aggravation of the proliferative complications of these disorders.

Influence of coronary artery bypass grafting on heart rate turbulence parameters.

This study evaluated the influence of coronary artery bypass grafting on heart rate turbulence (HRT) parameters assessed during 1-year follow-up in patients with coronary artery disease. HRT and heart rate variability (HRV) parameters significantly worsened 3 months after surgery. After 1 year, HRV parameters and turbulence onset returned to preoperative values, whereas turbulence slope remained significantly attenuated. Our results show that there is a marked attenuation of HRT parameters in the early postoperative period, indicating an impairment of baroreflex sensitivity after coronary artery bypass grafting. Concomitant depression of HRV parameters points to dysfunction of the autonomic nervous system, provoked by perioperative attenuation, as a potential underlying cause of impaired baroreflex response.

Sex steroids and heart rate variability in patients after myocardial infarction.

BACKGROUND: Although the relationship between sex steroid levels and coronary artery disease (CAD) has been the subject of many studies there are still controversies concerning the role of sex steroids in CAD. In patients with CAD, especially after a myocardial infarction, there is evidence for autonomic nervous system dysfunction. However, there is no data detailing the relationship between sex steroids and cicardian autonomic activity in patients with CAD. The aim of the study was to evaluate the association between sex steroids and heart rate variability (HRV) parameters in postinfarction patients. METHODS: In 88 postinfarction men (aged 36-73, average 53 years), 24-hour Holter monitoring was performed to assess HRV parameters: SDNN, SDNNI, SDANN, rMSSD, pNN50, and levels of the following hormones were measured: testosterone, estradiol, free testosterone index, and estradiol/testosterone ratio. Univariate and multivariate regression analyses were used to investigate the relationship between HRV parameters and levels of tested hormones. RESULTS: Increased testosterone levels were associated with increased SDNN (r = 0.38, P = 0.03), increased rMSSD (r = 0.51, P = 0.002), and increased pNN50 (r = 0.45, P = 0.007). These associations remained significance after adjustment for age, ejection fraction, and other relevant clinical covariates. There was no significant association between estradiol and HRV parameters. CONCLUSION: In men with a history of myocardial infarction, higher levels of testosterone are associated with higher HRV measures of parasympathetic activity. These findings suggest that testosterone beneficially influences autonomic regulation of the heart.

[Sex steroids and heart rate variability in men with coronary artery disease after myocardial infarction]. / Steroidy plciowe a zmiennosc rytmu serca u mezczyzn z choroba wiencowa po zawale serca.

The role of sex steroids in coronary artery disease (CAD) has been studied for years. In patients after myocardial infarction autonomic nervous system dysfunction has been described. Heart rate variability (HRV) analysis is one of the method of autonomic nervous system evaluation. The aim of the study was to evaluate correlations between sex steroids and HRV in 88 men (aged 36-73, av. 53 yrs), with the history of MI, with angiographically documented CAD. In all the patients 24-hour Holter monitoring was performed to assess HRV time domain parameters: SDNN, SDNNI, SDANN, rMSSD, pNN50. Levels of testosterone and estradiol were measured in two subsequent blood samples, taken with 30 min interval. Free testosterone index as well as estradiol/testosterone ratio were assessed. For statistics r-Spearman test was used. Positive correlations were found between testosterone and SDNN (r = 0.38, p = 0.03), testosterone and rMSSD (r = 0.51, p = 0.002) and between testosterone and pNN50 (r = 0.45, p = 0.007). Since rMSSD and pNN50 are parameters describing parasympathetic activity, our results suggest that in CAD men with the history of myocardial infarction, testosterone may influences the function of autonomic nervous system promoting parasympathetic dominance. It can be favorable for the circulatory system function.