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The implantable cardioverter-defibrillator (ICD) and subcutaneous ICD (S-ICD) are well-accepted life-saving devices for treating potentially lethal ventricular arrhythmia, but little is known about quality of life (QoL) in patients with S-ICD and ICD.Our study aimed to compare QoL in patients with S-ICD and ICD.All consecutive patients who had S-ICD implanted between October 2015 and September 2021 were included in the study. A cohort of transvenous ICD (TV-ICD) patients was matched to S-ICD subjects by sex, age, indications for the device, and type of prevention. All patients were requested to fulfill two standardized questionnaires to assess QoL: 36-Item Short Form Health Survey (SF-36) and Minnesota Living with Heart Failure Questionnaire (MLHFQ) 6 months after device implantation.Patients with S-ICD (n = 49) and TV-ICD (n = 49) did not differ regarding baseline characteristics. There were no statistically significant differences between S-ICD and TV-ICD subgroup, both for mental and physical QoL assessed in SF-36 and MLHFQ (all P = NS). The median MLHFQ total score was 24 (9-41) for S-ICD and 28 (14-43) for TV-ICD (P = 0.83). The median total score for the SF-36 questionnaire was 62.5 (29-86) vs. 59 (38-77) for S-ICD and TV-ICD, respectively (P = 0.78).Quality of life after device implantation does not differ significantly between the groups of patients with subcutaneous and conventional implantable cardioverter-defibrillator.

Background: Diabetes mellitus (DM) is a well-known risk factor for atrial fibrillation (AF), but the mechanism(s) by which DM affects AF prevalence remains unclear. This study aims to evaluate the impact of diabetes mellitus severity (expressed as its known duration), antihyperglycemic treatment regimen and glycaemic control on AF prevalence. Methods: From the representative sample of 3014 participants (mean age 77.5, 49.1% female) from the cross-sectional NOMED-AF study, 881 participants (mean age 77.6 ± 0.25, 46.4% female) with concomitant DM were involved in the analysis. AF was screened using a telemonitoring vest for a mean of 21.9 ± 9.1 days. Results: The mean DM duration was 12 ± 0.35 years, but no significant impact of DM timespan on AF prevalence was observed. No differences in the treatment pattern (oral medication vs insulin vs both oral + insulin) among the study population with and without AF were shown (p = 0.106). Metabolic control reflected by HbA1c levels showed no significant association with AF and silent AF prevalence (p = 0.635; p = 0.094). On multivariate analyses, age (Odds Ratio (OR) 1.35, 95%CI: 1.18-1.53, pTrial registration: NCT03243474

IntroductionThe aim of the study was to analyse microbiological charac�teristics and clinical manifestations of cardiac device-related infective endo�carditis (CDRIE) in cardiac resynchronization therapy (CRT) recipients, and to compare the diagnostic value of modified Duke (MDC) versus modified Duke lead criteria (MDLC; including to MDC local infection and pulmonary infection or embolism as major criteria).Material and methodsThe study population comprised 765 consecutive CRT patients from a high-volume, tertiary care centre from 2002 to 2015. All patients were screened for CDRIE.ResultsDuring a median follow-up of 1692 days (range: 457–3067) 5.36% of patients (n = 41) developed CDRIE, which was accompanied by CRT pocket infection in 17.1% (n = 7) and recurrent pulmonary infection or pulmonary embolism in 29.3% (n = 12). Fever was present in 95.1% of patients (n = 39), whereas blood cultures were positive in 65.9% (n = 27). Staphylococcus was the most prevalent pathogen in 59.3% (n = 16), Gram-negative bacteria in 25.9% (n = 7). Transoesophageal echocardiography showed intracardiac veg�etations in 73.2% of patients (n = 30). Non-different pathogen types with the most common methicillin-sensitive Staphylococcus aureus were observed for early versus late CDRIE (endocarditis ≤ 6 vs. > 6 months from CRT or other de�vice-related procedure). All 3 inflammatory markers (C-reactive protein, white blood cells, procalcitonin) were normal in 4.9% of patients (n = 2). MDC versus MDLC indicated definite CDRIE in 48.8% versus 80.5%, respectively (p = 0.003).ConclusionsFever is the most common symptom of CRT-related CDRIE, and transoesophageal echocardiography allows vegetations to be visualised in nearly 3/4 of patients with CDRIE. Although the most common pathogens were Staphylococci, Gram-negative bacteria accounted for a quarter of CDRIE. Modified Duke lead criteria proved superior to MDC.

Background: Dietary modifications are recommended alongside pharmacotherapy in treating both diabetes mellitus (DM) and coronary heart disease (CHD) patients. Aims: The primary aim of our study was to assess the diet in patients with type 2 diabetes mellitus (T2DM) and myocardial infarction (MI) and to identify dietary differences between patients after the first and subsequent cardiovascular (CV) event. The secondary aim was to analyze the differences between men’s and women’s diets. Methods: The study population consisted of patients with DM/T2DM and MI. The research tool was the original author’s questionnaire which was collected personally by a qualified dietician. Results: The study included 67 patients with a mean age of 69 ± 8 years, hospitalized at the Silesian Centre for Heart Diseases in Zabrze in 2019. The study found that patients consumed less bread, whole-grain cereal products, fermented milk products, and vegetables than was recommended. A total of 32.8% of patients reported an intake of sweetened beverages, while 85.1% of participants consumed sweets despite being diagnosed with DM. Except for sweetened drinks, no differences in dietary behaviors were found in the patients after the first and second MI episode. Most of the included patients assessed their diet as appropriate. Conclusion: The dietary assessment of diabetes and myocardial infarction patients indicates that the diet does not comply with dietary recommendations, thus increasing the risk of a recurrent cardiac event despite a previous MI. No differences between the men’s and the women’s nutritional habits were observed.

Aims The number of patients with heart failure (HF) and implantable cardiac electronic devices has been growing steadily. Remote monitoring care (RC) of cardiac implantable electronic devices can facilitate patient-healthcare clinical interactions and prompt preventive activities to improve HF outcomes. However, studies that have investigated the efficacy of remote monitoring have shown mixed findings, with better results for the system including daily verification of transmission. The purpose of the RESULT study was to analyse the impact of remote monitoring on clinical outcomes in HF patients with implantable cardioverter-defibrillator [ICD/cardiac resynchronization therapy-defibrillator (CRT-D)] in real-life conditions. Methods and results The RESULT is a prospective, single-centre, randomized trial. Patients with HF and de novo ICD or CRT-D implantation were randomized to undergo RC vs. in-office follow-ups (SC, standard care). The primary endpoint was a composite of all-cause death and hospitalization due to cardiovascular reasons within 12 months after randomization. We randomly assigned 600 eligible patients (299 in RC vs. 301 in SC). Baseline clinical and echocardiographic characteristics were well-balanced and similar in both arms. The incidence of the primary endpoint differed significantly between RC and SC and involved 39.5% and 48.5% of patients, respectively, (P = 0.048) within the 12-month follow-up. The rate of all-cause mortality was similar between the studied groups (6% vs. 6%, P = 0.9), whereas hospitalization rate due to cardiovascular reasons was higher in SC (37.1% vs. 45.5%, P = 0.045). Conclusion Remote monitoring of HF patients with implanted ICD or CRT-D significantly reduced the primary endpoint rate, mostly as a result of a lower hospitalization rate in the RC arm (ClinicalTrials.gov Identifier: NCT02409225).

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.

The current AF definition requires recording in classical ECG or Holter ECG at least a 30-s episode of AF. According to the current definition, the presence of frequent shorter episodes of fast atrial arrhythmia or episodes of arrhythmia identified with widely used screening tools requires subsequent steps to establish a definite diagnosis of AF. The use of different clinical risk scores can help to refine target populations better. Due to the unpredictable and highly variable nature of AF episodes, a monitoring time lasting 2 weeks or longer is preferable to maximize the possibility of identifying subjects with AF. Several capabilities are currently available for AF search/screening, including devices based on plethysmographic pulse assessment, belts and vests for long-term ECG monitoring, modern Holter capabilities, and ILRs. Decision-making regarding using particular of them should depend on proof of efficacy based on published data, patient characteristics, and purpose of monitoring (screening/search). Additionally, all subjects with CIED with the possibility of atrial sensing should be carefully evaluated to identify AHREs. In large-scale screening projects, ML and AI could provide the appropriate interpretation of large databases containing the results of a giant number of participants. From the patient perspective, participation in screening has positive but also negative aspects. Therefore, each patient should be able to accept or refuse to participate in a screening programme, being fully aware of the potential benefits or hurdles of the screening. As the first step of shared decision-making, identifying a patient’s values, goals, and preferences is mandatory.

Scant data exist on long-term outcomes, including death, in patients with complica-tions related to transvenous lead extractions (TLE).We sought to characterize the population and examine the outcomes including risk factors for in-hospital complications and 12-month mortality and morbidity related to the complications in a large administrative database of patients undergoing TLE.From the database of patients hospitalized for cardiovascular diseases and included in the Silesian Cardiovascular Database (SILCARD) registry, we selected the admissions of those who underwent TLE according to the appropriate ICD-9 codes. The patients were divided into two groups based on whether they did or did not manifest any complications during their hospitalization for the TLE procedure. Between 2007 and 2019, we found a total of 835 patients who underwent TLE. TLE-related complications occurred in 56 patients (6.7%) of the Complications-Yes group while no complications were recorded in 779 (93.3%) patients of the Complications-No group. A significant difference in the rate of all-cause mortality (23.9% vs. 6.5%; P0.001) and major adverse cardiac events (MACE) (58.7% vs. 39.4%; P = 0.01) between the Complications-Yes and Complications-No groups were recorded. Multivariable analysis of the entire study population revealed that prior dialysis, chronic kidney disease, and ventricular tachycardia were independent factors of a higher risk of TLE-related in-hospital complications. Multivariable analysis of the patients discharged from the hospital after the TLE procedure showed that TLE-related complications, a history of heart failure, and older age independently affected 12-month mortality.The presence of TLE-related in-hospital complications increased 12-month mortality.

Background Asymptomatic (“silent”) atrial fibrillation is common and associated with poor outcomes. It is important to determine the risk factors that predispose elderly individuals from the general population to atrial fibrillation (AF). However, population-based data for silent AF (SAF) are limited. Design First, to study the risk factors for symptomatic AF and SAF in an elderly (≥65 years) general population. Second, to develop a risk stratification model for predicting SAF. Methods Continuous ECG monitoring was performed for up to 30 days using a vest-based system in a cohort from NOMED-AF, a cross-sectional study based on a nationwide population sample. The independent risk factors for AF and SAF were determined using multiple logistic regression. ROC analysis was applied to validate developed risk stratification score. Results From the total cohort of 3014 subjects, AF was diagnosed in 680 individuals (mean age, 77.5±7.9; 50.1% men) with AF, and of these, 279 (41%) had SAF. Independent associations with an increased risk of AF were age, male gender, coronary heart disease, thyroid diseases, prior ischemic stroke or transient ischemic attack (ICS/TIA), diabetes, heart failure, chronic kidney disease (CKD), obesity (BMI>30) and NT-proBNP >125 ng/ml. Prior revascularization was negatively associated with risk of AF. The main risk factors for SAF were age, male gender, prior ICS/TIA, diabetes, heart failure, CKD and NT-proBNP >125 ng/ml. We developed a simple clinical risk scale (MR-DASH score) which had good prediction in the derivation cohort (AUC 0.726) and the validation cohort (AUC 0.730). Conclusions SAF is associated with various clinical risk factors in a population sample of individuals ≥65 years. Stratifying individuals from the general population according to their risk for SAF may be possible using the MR-DASH score, facilitating targeted screening programs of individuals with high risk of SAF Funding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): National Centre for Research and Development

Background Advanced heart failure with reduced ejection fraction (HFrEF) is associated with poor prognosis. Cardiac resynchronization therapy (CRT) is an effective method of treatment for advanced HFrEF to reduce HF hospitalizations and mortality. Nonetheless, very long-term observation of HF patients undergoing CRT implantation is scarce. Aim To assess very long-term survival (≥10 years) and predictors of shorter survival (death within 10 years from CRT implantation). Methods We screened a large dataset of CRT population from a tertiary care university hospital comprising consecutive HF patients implanted with CRT from 2002 through 2019 to select those who were alive ≥10 years and those who died within 10 years since device implantation. We analyzed various patients' baseline, clinical and procedural characteristics and sought for predictors of mortality within 10 years from CRT implantation. Results Of 1059 CRT patients, 143 (13.5%) were alive ≥10 years since CRT implantation. On multivariable regression analysis the independent predictors for all-cause death up to 10 years from CRT implantation were as follows: age, HR 1.02, 95% CI 1.01–1.31; male sex, 1.27, 95% CI 1.01–1.60; primary prevention of sudden cardiac death (SCD), HR 0.72, 95% CI 0.58–0.89; ischemic cardiomyopathy, HR 1.41, 95% CI 1.76–1.70; NYHA class at implantation, HR 1.38, 95% CI 1.17–1.62; baseline left ventricle ejection fraction (EF), HR 0.97, 95% CI 0.96–0.98; severe mitral regurgitation, HR 1.38; 95% CI 1.08–1.75; baseline NT-proBNP concentration, HR 1.00, 95% CI 1.00–1.00; and creatinine level, HR 1.00, 95% CI 1.00–1.01. Conclusions In a real-life patient population with CRT only 13.5% survived over 10 years since device implantation. Independent predictors for death within 10 years since CRT implantation were older age, male sex, secondary prevention of SCD, ischemic and more advanced heart failure along with renal impairment. Funding Acknowledgement Type of funding sources: None.

Background Cardiac resynchronization therapy (CRT) is an effective method of treatment in patients with HF, but as complex device with three electrodes, it is prone to electrode dysfunctions and the need to replace them. However little is known about the frequency of need for leads replacement in subjects undergone CRT in a very long-term follow up. Aim To determine the frequency of leads replacement in patients undergoing CRT during long term follow-up. Methods Study population consisted of 1059 consecutive patients with CRT implanted between 2002 and 2019 in tertiary care university hospital, in a densely inhabited, urban region of Poland. The data about lead replacement was collected. Results During the median follow-up of 1661 days (IQR: 815–2792) for non-infectious reasons (dislocation, dysfunction, fracture etc.) a total of 324 leads in 251 patients (23.7%) were replaced. Median time from CRT implantation to the first lead replacement was 359 days (42–1413). The electrode replacement within first year after CRT implantation was performed in 126 subjects (50.2%), in the rest of patients (49.8%) the leads were replaced after one year of device implantation. In patients with above ten years of follow up (n=143; 13.5%) 67 subjects (46.8%) had one or more lead replacement during follow up. Patients with electrode replacement during follow-up were younger (63 vs 66 years, P Conclusions The need for leads replacement due to non-infectious reasons reaches almost 25% of patients with CRT within 4.5 years. Half of the patients have lead replacement within one year after CRT implantation and the other half during long term follow up. The duration of the first procedure (CRT device implantation) is strong predictor of lead replacement during follow up. Funding Acknowledgement Type of funding sources: None.

Background In prior unblinded studies, cardiac neuromodulation therapy (CNT) employing a sequence of variably timed short and longer atrioventricular intervals yielded sustained reductions of systolic blood pressure (SBP) in patients with hypertension. The effects of CNT on SBP were investigated in this double‐blind randomized pilot study. Methods and Results Eligible patients had daytime ambulatory SBP (aSBP) ≥130 mm Hg and office SBP ≥140 mm Hg despite taking ≥1 antihypertensive medication, and an indication for a dual‐chamber pacemaker. Patients underwent Moderato device implantation, which was programmed as a standard pacemaker during a 1‐month run‐in phase. Patients whose daytime aSBP was ≥125 mm Hg at the end of this period were randomized (1:1, double blind) to treatment (CNT) or control (CNT inactive). The primary efficacy end point was the between‐group difference of the change in 24‐hour aSBP at 6 months. Of 68 patients initially enrolled and who underwent implantation with the Moderato system, 47 met criteria for study continuation and were randomized (26 treatment, 21 control). The mean age was 74.0±8.7 years, 64% were men, left ventricular ejection fraction was 59.2%±5.7%, and aSBP averaged 141.0±10.8 mm Hg despite the use of 3.3±1.5 antihypertensive medications; 81% had isolated systolic hypertension. Six months after randomization, aSBP was 11.1±10.5 mm Hg (95% CI, −15.2 to −8.1 mm Hg) lower than prerandomization in the treatment group compared with 3.1±9.5 mm Hg (−7.4 to 1.2 mm Hg) lower in controls, yielding a net treatment effect of 8.1±10.1 mm Hg (−14.2 to −1.9 mm Hg) ( P =0.012). There were no Moderato device– or CNT‐related adverse events. Conclusions CNT significantly reduced 24‐hour aSBP in patients with hypertension with a clinical indication for a pacemaker. The majority of patients had isolated systolic hypertension, a particularly difficult group of patients to treat. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02837445.

Atrial lead implantation commonly constitutes a technical problem, especially in patients with improper structure of the right atrium. The atrial lead displacement requires reimplantation, what creates a risk of infection and periprocedural complications, particularly in patients with the heart failure. To minimise the risk of complications, it is essential to asses potential difficulties before the procedure. The article concerns the patient with many burdens (right and left ventricular systolic dysfunction, tricuspid valve regurgitation, paroxysmal atrial fibrillation and atrial flutter, catheter ablation of both types of the arrhythmias, CRT device implantation), who was repeatedly hospitalized due to atrial lead displacement and who underwent implantation of Medtronic SelectSecure 3830 lead, what finally provided to stable placement of the lead in the right atrium.

Background: Silent atrial fibrillation (SAF) is common and is associated with poor outcomes. Aims: to study the risk factors for AF and SAF in the elderly (≥65 years) general population and to develop a risk stratification model for predicting SAF. Methods: Continuous ECG monitoring was performed for up to 30 days using a vest-based system in a cohort from NOMED-AF, a cross-sectional study based on a nationwide population sample. The independent risk factors for AF and SAF were determined using multiple logistic regression. ROC analysis was applied to validate the developed risk stratification score. Results: From the total cohort of 3014 subjects, AF was diagnosed in 680 individuals (mean age, 77.5 ± 7.9, 50.1% men) with AF, and, of these, 41% had SAF. Independent associations with an increased risk of AF were age, male gender, coronary heart disease, thyroid diseases, prior ischemic stroke or transient ischemic attack (ICS/TIA), diabetes, heart failure, chronic kidney disease (CKD), obesity, and NT-proBNP &gt, 125 ng/mL. The risk factors for SAF were age, male gender, ICS/TIA, diabetes, heart failure, CKD, and NT-proBNP &gt, 125 ng/mL. We developed a clinical risk scale (MR-DASH score) that achieved a good level of prediction in the derivation cohort (AUC 0.726) and the validation cohort (AUC 0.730). Conclusions: SAF is associated with various clinical risk factors in a population sample of individuals ≥65 years. Stratifying individuals from the general population according to their risk for SAF may be possible using the MR-DASH score, facilitating targeted screening programs of individuals with a high risk of SAF.

Background The global burden of atrial fibrillation (AF) and diabetes mellitus (DM) is constantly rising, leading to an increasing healthcare burden of stroke. AF often remains undiagnosed due to the occurrence in an asymptomatic, silent form, i.e., silent AF (SAF). The study aims to evaluate the relationships between DM and AF prevalence using a mobile long-term continuous ECG telemonitoring vest in a representative Polish and European population ≥ 65 years for detection of AF, symptomatic or silent. Methods A representative sample of 3014 participants from the cross-sectional NOMED-AF study was enrolled in the analyses (mean age 77.5, 49.1% female): 881 (29.2%) were diagnosed with DM. AF was screened using a telemonitoring vest for a mean of 21.9 ± 9.1days. Results Overall, AF was reported in 680 (22.6%) of the whole study population. AF prevalence was higher among subjects with concomitant DM (DM+) versus those without DM (DM−) [25%, 95% CI 22.5-27.8% vs 17%; 95% CI 15.4–18.5% respectively, p Conclusions AF affects 1 out of 4 subjects with concomitant DM. The higher prevalence of AF and SAF among DM subjects than those without DM highlights the necessity of active AF screening specific AF risk factors assessment amongst the diabetic population. Trial registration: NCT03243474

Background Triple-Site versus Standard Cardiac Resynchronization Therapy Randomized Trial (TRUST CRT) was initiated in 2009 to verify the hypothesis whether triple-site (single right, double left) cardiac resynchronization therapy (CRT) may be superior to conventional, biventricular resynchronization in patients with advanced heart failure. Objectives To report 6-month outcomes and 10-year survival in TRUST CRT. Methods 100 consecutive patients with moderate to severe heart failure, ejection fraction of 35% or less, electrical and mechanical dyssynchrony, were randomly assigned in a 1:1 fashion to triple-site CRT defibrillator (TRIV) or to conventional CRT-D. The primary objective evaluated response-rate, defined as the 6-month's combined end point of alive status, freedom from hospitalization for heart failure or heart transplantation, relative≥10% increase in ejection fraction, ≥10% in peak oxygen consumption, and ≥10% in 6-minute walking distance. The secondary objective was to assess the occurrence of major adverse cardiovascular events (hospitalization for exacerbated heart failure requiring modification of pharmacotherapy, heart transplant or death) at month 6 and during remote observation. Results At month 6, the response-rate was higher in triple-site than conventional CRT-D group (51.1 vs. 26.5%, P=0.014). There were 2 deaths or heart failure events in the triple-site group (4%) as compared with 8 in the group assigned to conventional CRT-D (16%). A triple-site resynchronization resulted in 12% absolute risk reduction for secondary end point (hazard ratio 0.25; 95 percent confidence interval, 0.05 to 1.17, P=0.056, in comparison with the conventional CRT-D group). After 10 years of observation (median follow up of 7.1 years; range: 1.2–10.4) 57 patients (58.2%) died: 24 (53.3%) in the triple-site group, 31 (60.8%) in the conventional group (P=0.46) and 2 patients with and ICD (failed CRT implantation) [Figure]. Conclusions In patients with advanced heart failure, triple-site resynchronization combined with an ICD did not result in better survival than conventional resynchronization therapy in a median observation of 7.1 years. Figure 1 Funding Acknowledgement Type of funding source: None

Background It is important to determine the risk factors that predispose elderly subjects from the general population for symptomatic atrial fibrillation and atrial flutter (AF/AFl), but population-based data for silent AF (SAF) are limited. Aim To study risk factors for symptomatic AF and SAF in a general population screen for subjects age ≥65 where continuous monitoring was performed up to 30 days with a vest-based monitor. Methods The NOMED-AF study was a cross-sectional study based on a representative population sample (n=3014; mean age 77.5±7.9 years; F=1479). In 680 subjects AF/AFl (including 279 with SAF) was diagnosed. Independent risk factors for AF/AFl and SAF were determine on weighted data using multiple logistic regression. Results The independent risk factors for AF/AFl and SAF are summarised in the Table. There are nine independent risk factors for AF/AFl and eight for SAF. Revascularization and obesity were independently associated with patients with (symptomatic) AF/AFl, and CKD was associated with SAF. Other risk factors are common for AF/AFl and SAF. Conclusions AF/AFl and SAF have slightly different associated clinical risk factors in this representative population sample aged ≥65 years. This may facilitated targeted screening programmes for high risk subgroups, particularly for SAF. Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): The research has received funding from the National Centre for Research and Development under grant agreement (STRATEGMED2/269343/18/NCBR/2016)

Aim To assess the incidence, clinical significance of depression and the impact of a cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D) implantation on psychiatric status in patients with heart failure (HF). Methods The prospective, single-center study encompassed 575 consecutive HF patients implanted with a CRT-D or ICD. Finally, the study population consisted of 494 subjects (186 ICD and 308 CRT-D patients), as 81 patients taking antidepressants were excluded from the analysis. All patients underwent psychiatric examination at the time of implantation, and the assessment of psychiatric status was repeated after 3, 6, 12 and 24 months. The study population was divided into 4 groups: Group 1 encompassed 101 (20.4%) patients with persistent depression, Group 2 constituted of 95 (19.2%) patients with depression that developed after ICD/CRT-D implantation, whereas 43 (8.7%) patients with remission of depression comprised Group 3, and Group 4 encompassed 255 (51.6%) patients with never diagnosed depression. Data on long-term follow-up (median 34.1 months) were screened to identify patients who developed a composite endpoint defined as death or hospitalization for decompensated HF. Results The cumulative incidence of depression at the baseline assessment was 39.1%. Depression developed in 95 (27.1%) patients, whereas remission of depression was observed in 43 (29.9%) subjects after ICD/CRT-D implantation. ICD intervention (HR 3.3) and increase in NYHA class by at least one class (HR 2.6) were the independent risk factors for depression development, whereas mitral regurgitation reduction (HR 1.9), as well as improvement in NYHA class by at least one class (HR 2.4) were the independent predictors for depression remission. Patients with persistent depression (Group 1) and those with newly developed depression (Group 2) were at significantly higher risk of a composite endpoint compared to patients in Group 3 and Group 4 (Table 1). Conclusions Depression is a common comorbidity associated with HF, as it affects 4 of 10 HF patients. ICD intervention and HF worsening are the strongest predictors for depression development after ICD/CRT-D implantation. Depression is a strong, independent risk factor of poor outcomes in HF population. Funding Acknowledgement Type of funding source: None

Background Atrial fibrillation (AF) confers a high healthcare burden from stroke, heart failure, dementia and hospitalisation, and one challenge is. Early detection of this arrhythmia in the community, given that it is often asymptomatic. Aim To perform population screening for atrial fibrillation and flutter (AF/AFl) using a mobile long-term continuous ECG telemonitoring vest in a representative Polish and European population aged ≥65 years (age range 65–100 years). Methods The NOMED-AF study is a cross-sectional study based on a representative sample of adults aged ≥65 years (n=3014; mean age 77.5±7.9 years; 49.1% female). All study participants were equipped with a mobile long-term continuous ECG telemonitoring vest. National and European estimations were calculated on weighted data. Results In 680 subjects AF/AFl (including 279 with SAF; 9.3%) was confirmed. In the NOMED-AF population, the prevalence of AF/AFl was 22.6%, estimated to be 19.2% for Poland [1,251,100 (95% CI: 1,158,300–1,344,000) and 480,100 (95% CI: 426,60–533,700) subjects with AF/AFl and SAF, respectively] and 20.4% for Europe [20,300,000 (95% CI 18.8–21.9 M), including 8,000,000 (95% CI: 6.9–9.3 M) subjects with AF/AFl and SAF, respectively]. The prevalence of AF/AFl was 2.56-fold higher in men than in women and the incidence of silent AF (SAF) was 4.73-fold higher in men than in women. Although the risk of either AF/AFl or SAF increased with age, the odds ratio was significantly higher in women of a particular age group than in men of the corresponding age. Based on our survey, the total number of subjects with AF/AFl in Europe is estimated to be roughly 20.3 million (95% CI 18.8–21.9M), including 8.0 million (95% CI: 6.9–9.3M) subjects with silent AF/AFl (Figure). Conclusions Approximately 1 in 5 subjects aged ≥65 years suffers from AF/AFl. The risk for AF/AFl and SAF is higher in men than that in women, but when correlated to a particular age group, the risk increases significantly in women. Continuous ECG telemonitoring allows for more credible AF/AFl and SAF detection. Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): The research has received funding from the National Centre for Research and Development under grant agreement (STRATEGMED2/269343/18/NCBR/2016

Aims To assess and compare long-term mortality and predictors thereof in de novo cardiac resynchronization therapy defibrillators (CRT-D) vs. upgrade from an implantable cardioverter-defibrillator (ICD) to CRT-D. Methods and results Study population consisted of 595 consecutive patients with CRT-D implanted between 2002 and 2015 in a tertiary care, university hospital, in a densely inhabited, urban region of Poland [480 subjects (84.3%) with CRT-D de novo implantation; 115 patients (15.7%) upgraded from ICD to CRT-D]. In a median observation of 1692 days (range 457–3067), all-cause mortality for de novo CRT-D vs. CRT-D upgrade was 35.5% vs. 43.5%, respectively (P = 0.045). On multivariable regression analysis including all CRT recipients, the previously implanted ICD was an independent predictor for death [hazard ratio (HR) 1.58, 95% confidence interval (CI) 1.10–2.29, P = 0.02]. For those, who were upgraded from ICD to CRT-D, the independent predictors for all-cause death were as follows: creatinine level (HR 1.01, 95% CI 1.00–1.02, P = 0.01), left ventricular end-systolic diameter (HR 1.07, 95% CI 1.02–1.11, P = 0.002), New York Heart Association (NYHA) IV class at baseline (HR 2.36, 95% CI 1.00–5.53, P = 0.049) and cardiac device-related infective endocarditis during follow-up (HR 2.42, 95% CI 1.02–5.75, P = 0.046). A new CRT scale (Creatinine ≥150 μmol/L; Remodelling, left ventricular end-systolic ≥59 mm; Threshold for NYHA, NYHA = IV) showed high prediction for mortality in CRT-D upgrades (AUC 0.70, 95% CI 0.59–0.80, P = 0.0007). Conclusion All-cause mortality in patients upgraded from ICD is significantly higher compared with de novo CRT-D implantations and reaches almost 45% within 4.5 years. A new CRT scale (Creatinine; Remodelling; Threshold for NYHA) has been proposed to help survival prediction following CRT upgrade.

Background: Cardiac device-related infective endocarditis (CDRIE) is one of the most serious complications of cardiac resynchronisation therapy (CRT). Aim: We sought to assess clinical outcomes and their determinants in CRT patients with CDRIE. Methods: A tertiary cardiology centre database was screened to identify all CDRIE cases, diagnosed based on the modified Duke criteria, amongst 765 consecutive CRT implantations performed between 2002 and 2015 (70.8% de novo implantations, 29.2% upgrades). Results: During the median follow-up of 1692 days (range: 457–3067 days) CDRIE was diagnosed in 41 (5.4%) patients. Overall, in-hospital and long-term mortality rates of CDRIE patients were 51.2% and 75.6%, respectively. Among patients with CDRIE, in whom the device was vs. was not explanted, in-hospital death rates were 39.3% (11/28 patients) vs. 76.9% (10/13 patients; p = 0.025). In multivariate regression analysis, device removal was independently associated with significantly lower in-hospital mortality (hazard ratio [HR] 0.09, 95% confidence interval [CI] 0.03–0.35, p = 0.0004). The need for temporary pacing after device removal (HR 5.92, 95% CI 1.13–30.96, p = 0.035), a time period of less than seven days between CDRIE diagnosis and CRT removal (HR 6.69, 95% CI 1.48–30.27, p = 0.01), and the highest serum creatinine level during infection (HR 1.02, 95% CI 1.004–1.03, p = 0.01) were identified as independent predictors of higher in-hospital mortality. Conclusions: Device removal is independently associated with lower mortality in patients with CRT and CDRIE. Early device removal (less than seven days since the diagnosis), the need for temporary pacing after removal and acute renal failure are independent mortality predictors in CRT patients who developed CDRIE.

Heart transplant is an accepted treatment modality in end-stage heart failure. The graft coronary artery vasculopathy is a main concern to explain the heterogeneity of the rejection process according to the gender of the donor and recipient.To assess the severity and type of mechanisms leading to failure of the graft.Experimental allogenic heart transplantation in the abdomen was performed on Wistar rats depending on the gender of the donor and recipient (F - female; M - male) in four groups (FF, FM, MM MF). The donor heart was implanted in the abdominal cavity of the recipient. Complete time of observation was 10 weeks. Bromodeoxyuridine was administered intraperitoneally to detect proliferating cells.There was 42.5% graft survival in all experiments. The mean time of graft survival was 60 ±18, 54 ±29, 58 ±23 and 64 ±18 days (FF, FM, MM and MF) and no significant difference was found in graft survival time among the four experimental groups (The use of an animal experimental model helps to understand the mechanisms leading to graft failure and to compare the changes that occur in rats to human hearts. The gender matching affects the survival of the transplanted heart and severity of the graft vasculopathy.Transplantacja serca jest uznaną metodą postępowania w krańcowym stadium kardiomiopatii o różnej etiologii, niewydolności oraz nieoperacyjnych wad wrodzonych serca. Choroba naczyń wieńcowych serca przeszczepionego stanowi główną przyczynę upośledzenia funkcji narządu. Zwraca uwagę niejednolitość przebiegu tego procesu w zależności od płci dawcy i biorcy.Ocena nasilenia i przyczyn niewydolności przeszczepionego serca.Zabieg dobrzusznego wszczepienia serca wykonywano w zależności od płci dawcy i biorcy (samica – F, samiec – M) w czterech grupach (FF, FM, MM MF). Okres obserwacji wynosił 10 tygodni. Podano dootrzewnowo bromodeoksyurydynę (BrdU) w celu wykrycia komórek proliferujących.Przeżywalność przeszczepionego narządu w eksperymencie wynosiła 42,5%. Średni czas przeżycia narządu wynosił 60 ±18, 54 ±29 58 ±23 oraz 64 ±18 dni, odpowiednio dla grup FF, FM, MM oraz MF. Nie stwierdzono istotnych statystycznie różnic pomiędzy grupami w zakresie długości przeżycia narządu (Zastosowanie modelu zwierzęcego pozwala zrozumieć mechanizmy prowadzące do niewydolności przeszczepionego narządu oraz odnieść zmiany zachodzące u szczurów do zmian występujących u ludzi. Dobór płci dawcy i biorcy wpływa na przeżywalność przeszczepionego narządu i nasilenie choroby naczyń wieńcowych przeszczepu.

Background: GLORIA-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation) is a prospective, global registry program describing antithrombotic t...

Objectives: Chronic heart failure (HF) is associated with significantly increased prevalence of depression. The aim of the study was to assess the incidence and clinical impact of depression as well as the effectiveness of depression treatment in HF patients. Methods: A prospective interventional trial included 285 consecutive cardiac resynchronization therapy recipients. Patients underwent a psychiatric examination at the time of implantation and then it was routinely repeated at 3, 6, and 12 months after the procedure, and every 6 months thereafter. One hundred and thirty-five (47.4%) patients with depression were included in the depression group, whereas the control group was comprised of 150 patients free of depression. Sixty-eight (50.4%) subjects received antidepressants (treated group), whereas the observational group had 67 (49.6%) depressed patients who refused to take antidepressants. Results: Depression remission was achieved in 51 (75.0%) patients from the treated group. Long-term mortality and HF hospitalization rates were significantly higher in the depression group than in the control group (20.7 vs. 11.3% and 32.6 vs. 19.2%, respectively). However, remission from depression was associated with a 40% reduction in the relative risk of major adverse cardiac events (MACE). Conclusions: Patients with HF and concomitant depression are at higher risk of MACE compared with those free of depression. Effective antidepressant treatment may significantly improve long-term outcomes in this population.

To assess incidence, predisposing factors and outcomes of cardiac device-related infective endocarditis (CDRIE) in patients undergoing cardiac resynchronization therapy (CRT).High-volume, single-center cardiology database was screened to identify all CDRIE cases, based on modified Duke criteria, amongst 765 consecutive CRT implantations between 2002 and 2015 (70.8% de novo implantations, 13.7% and 15.5% up-grades from pacemaker and implantable cardioverter–defibrillator [ICD], respectively). During the median follow-up (FU) of 1207 days (range: 256–2664) overall 38 CDRIE (4.97%) cases were identified (incidence: 15/1000 person-years). Multivariate Cox regression model, incorporating significant baseline differences as covariates (model 1), demonstrated that both up-grade from ICD to CRT and higher baseline NYHA class were independently associated with increased risk of CDRIE (adjusted HR 4.29, 95%CI 1.93–9.57; and HR 2.43, 95%CI 1.32–4.49, respectively). In the second model (including all differences with P0.2) up-grade from ICD (HR 4.36, 95%CI 1.96–9.69), higher NYHA class (HR 2.04, 95%CI 1.11–3.75), hypertrophic cardiomyopathy (HR 5.85, 95% CI 1.46–23.52), lower baseline hemoglobin level (HR 0.68, 95%CI 0.50–0.94) and chronic obstructive pulmonary disease (HR 2.46, 95%CI 1.05–5.77) were all independently associated with higher risk of CDRIE. All-cause mortality in patients with CDRIE was significantly higher than in subjects without infective complications (68.4% vs. 33.7%, P0.001), and 50% of patients with CDRIE died during index hospitalization.The prevalence of CDRIE in CRT recipients is almost 5% within 3.5 years post implantation. Up-grade from ICD and high baseline NYHA class flag up patients at high-risk of CDRIE. CRT-related infective complications are associated with very poor prognosis.

Introduction: Vectorcardiographic (VCG) QRS area of left bundle branch block (LBBB) predicts acute hemodynamic response in cardiac resynchronization therapy (CRT) patients. We hypothesized that changes in QRS area occurring with biventricular pacing (BV) might predict acute hemodynamic CRT response (AHR). Methods and Results: VCGs of 624 BV paced electrocardiograms (25 LBBB patients with 35 different pacing configurations) were calculated according to Frank's orthogonal lead system. Maximum QRS vector amplitudes (X-Ampl, Y-Ampl, Z(Ampl), and 3D(Amp)) and QRS areas (X-Area, Y-Area, Z(Area), and 3D(Area)) in the orthogonal leads (X, Y, and Z) and in 3-dimensional projection were measured. Volume of the 3D vector loop and global QRS duration (QRSD) on the surface electrocardiogram were assessed. Differences (Delta) in VCG parameters between BV paced and LBBB QRS complexes were calculated. An increase of 10% in dP/dt max was considered as AHR. LBBB conduction is characterized by a large Z(Area) (109 mu Vs, interquartile range [ IQR]: 75; 135), significantly larger than X-Area (22 mu Vs, IQR: 10; 57) and Y-Area (44 mu Vs, IQR: 32; 62, P< 0.001). Overall, QRS duration, amplitudes, and areas decrease significantly with BV pacing (P

Incidence and clinical significance of transient, daily fluctuations of biventricular pacing percentage (CRT%) remain unknown. We assessed the value of daily remote monitoring in identifying prognostically critical burden of low CRT%.Prospective, single-centre registry encompassed 304 consecutive heart failure patients with cardiac resynchronization therapy defibrillators (CRT-D). Patients with 24-h episodes of CRT% loss95% were assigned to quartiles depending on cumulative time spent in low CRT%: quartile 1 (1-8days), 2 (9-20days), 3 (21-60days) and quartile 4 (60days). During median follow-up of 35months 51,826 transmissions were analysed, including 15,029 in 208 (68.4%) patients with episodes of low CRT%. Overall, mean CRT%≥95% vs.95% resulted in a 4-fold lower mortality (17.3 vs. 68.2%; p0.001). Fifty-four percent of patients experienced episodes of CRT% loss, despite 85.6% having mean CRT%≥95%. Mortality was lowest in quartile 1 (7.7%), while longer periods of CRT% loss resulted in significantly higher death rates (25.0 vs. 34.6 vs. 57.7%; quartiles 2-4 respectively, p0.001), despite mean CRT% still being ≥95% in quartiles 1-3. Cumulative low CRT% burden was the independent risk factor for death (HR 1.013; 95% CI 1.006-1.021; p0.001). Mortality rose by 1.3 and 49% with every additional day and quartile of CRT% loss, respectively.Daily remote monitoring allows one to detect 24-h episodes of CRT% loss95% in over two-thirds of CRT-D recipients during median observation of 3years. Cumulative low CRT% burden (in days) independently predicts mortality before mean CRT% drop.

Background: Multiple randomised clinical trials have proven that cardiac resynchronisation therapy (CRT) reduces morbidity and mortality in appropriately selected patients with congestive heart failure and is recommended for such patients as per the European Society of Cardiology guidelines. Aims: In this paper we compare the indications and demographics in cardiac resynchronisation recipients in Poland and other European countries. Methods: In 2015 and 2016 , physicians from 42 European countries participated in the second edition of the European Cardiac Resynchronisation Therapy Survey. For 14 months, 288 implanting centres gathered data regarding demography, indications, implanting methods, and guidance compatibility from 11,088 patients receiving CRT. Results: The survey revealed that a vast group of patients were eligible for CRT implantation (although some of them with rela­tively weak guidance recommendations) and showed essential variety in clinical practice when national data were benchmarked. Conclusions: The population of CRT recipients in Poland and other European countries did not differ in terms of demographic and clinical characteristics. In most cases, indications for CRT were in accordance with the guidelines; however some devices were implanted in patients beyond the guideline recommendations. For these procedures, the decision regarding CRT im­plantation relies mainly on the physicians’ experience.

Background: We sought to determine whether presence, amount and distribution of scar impacts the degree of acute hemodynamic response (AHR) with multisite pacing.Multi-vein pacing (MVP) or multipolar pacing (MPP) with a multi-electrode left ventricular (LV) lead may offer benefits over conventional biventricular pacing in patients with myocardial scar. Methods: In this multi-center study left bundle branch block patients underwent an hemodynamic pacing study measuring LV dP/dtmax. Patients had cardiac magnetic resonance scar imaging to assess the effect of scar presence, amount and distribution on AHR. Results: 24 patients (QRS 171 ± 20 ms) completed the study (83% male). An ischemic etiology was present in 58% and the mean scar volume was 6.0 ± 7.0%. Overall discounting scar, MPP and MVP showed no significant AHR increase compared to an optimized “best BiV” (BestBiV) site. In a minority of patients (6/24) receiver-operator characteristic analysis of scar volume (cut off 8.48%) predicted a small AHR improvement with MPP (sensitivity 83%, specificity 94%) but not MVP. Patients with scar volume > 8.48% had a MPP-BestBiV of 3 ± 6.3% vs. −6.4 ± 7.7% for those below the cutoff. There was a significant correlation between the difference in AHR and scar volume for MPP-BestBiV (R = 0.49, p = 0.02) but not MVP-BestBiV(R = 0.111, p = 0.62). The multielectrode lead positioned in scar predicted MPP AHR improvement (p = 0.04). Conclusions: Multisite pacing with MPP and MVP shows no AHR benefit in all-comers compared to optimized BestBiV pacing. There was a minority of patients with significant scar volume in relation to the LV site that exhibited a small AHR improvement with MPP.(Study identifier NCT01883141) Keywords: Cardiac resynchronization therapy, Multisite pacing, Acute hemodynamic response, Left ventricular scar