Electrical Diuretics: Dorsal Root Ganglion Stimulation to Increase Diuresis.

BACKGROUND: Stimulation of diuresis is an essential component of heart failure treatment to reduce fluid overload. Over time, increasing doses of loop diuretics are required to achieve adequate urine output, and approximately 30% to 45% of patients develop diuretic resistance. We investigated the feasibility of affecting renal afferent sensory nerves by dorsal root ganglion neurostimulation as an alternative to medication to increase diuresis. MATERIALS AND METHODS: Acute volume overload with an elevated and stable pulmonary capillary wedge pressure (PCWP) was induced by infusion of isotonic fluid in swine (N = 7). In each experiment, diuresis and blood electrolyte levels were measured during cycles of up to two hours (baseline, stimulation, poststimulation) through bladder catheterization. Efficacy was tested using bilateral dorsal root ganglion (bDRG) stimulation at the T11 and/or T12 vertebral levels. RESULTS: An elevated, stable PCWP (15 ± 4 mm Hg, N = 7) was obtained after uploading. Under these conditions, average diuresis increased 20% to 205% compared with no stimulation. Side effects such as motor stimulation were mitigated by decreasing current or terminated spontaneously without intervention. There was no negative effect on acute kidney function because blood electrolyte concentrations remained stable. When stimulation was deactivated, urine output decreased significantly but did not return to baseline levels, suggesting a carry-over effect of up to two hours. CONCLUSIONS: Electrical stimulation (bDRG) at T11 and/or T12 increased diuresis in an acute volume overload model. Side effects caused by unintended (motor) stimulation could be eliminated by reducing the electrical current while sustaining increased diuresis.

Relationship between diabetes mellitus and atrial fibrillation prevalence in the Polish population: a report from the Non-invasive Monitoring for Early Detection of Atrial Fibrillation (NOMED-AF) prospective cross-sectional observational study.

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 < 0.001]. DM patients were commonly associated with SAF [9%; 95% CI 7.9-11.4 vs 7%; 95% CI 5.6-7.5 respectively, p < 0.001], and persistent/permanent AF [12.2%; 95% CI 10.3-14.3 vs 6.9%; 95% CI 5.9-8.1 respectively, p < 0.001] compared to subjects without DM. The prolonged screening was associated with a higher percentage of newly established AF diagnosis in DM+ vs DM- patients (5% vs 4.5% respectively, p < 0.001). In addition to shared risk factors, DM+ subjects were associated with different AF and SAF independent risk factors compared to DM- individuals, including thyroid disease, peripheral/systemic thromboembolism, hypertension, physical activity and prior percutaneous coronary intervention/coronary artery bypass graft surgery. 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.

Upgrade from implantable cardioverter-defibrillator vs. de novo implantation of cardiac resynchronization therapy: long-term outcomes.

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.

Remote Supervision to Decrease Hospitalization Rate (RESULT) study in patients with implanted cardioverter-defibrillator.

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).

How to deliver personalized cardiac resynchronization therapy through the precise measurement of the acute hemodynamic response: Insights from the iSpot trial.

INTRODUCTION: New pacing technologies offer a greater choice of left ventricular pacing sites and greater personalization of cardiac resynchronization therapy (CRT). The effects on cardiac function of novel pacing configurations are often compared using multi-beat averages of acute hemodynamic measurements. In this analysis of the iSpot trial, we explore whether this is sufficient. MATERIALS AND METHODS: The iSpot trial was an international, prospective, acute hemodynamic trial that assessed seven CRT configurations: standard CRT, MultiSpot (posterolateral vein), and MultiVein (anterior and posterior vein) pacing. Invasive and noninvasive blood pressure, and left ventricular (LV) dP/dtmax were recorded. Eight beats were recorded before and after an alternation from AAI to the tested pacing configuration and vice-versa. Eight alternations were performed for each configuration at each of the five atrioventricular delays. RESULTS: Twenty-five patients underwent the full protocol of eight alternations. Only four (16%) patients had a statistically significant >3 mm Hg improvement over conventional CRT configuration (posterolateral vein, distal electrode). However, if only one alternation was analyzed (standard multi-beat averaging protocol), 15 (60%) patients falsely appeared to have a superior nonconventional configuration. Responses to pacing were significantly correlated between the different hemodynamic measures: invasive systolic blood pressure (SBP) vs noninvasive SBP r = 0.82 (P < .001); invasive SBP vs LV dP/dt r = 0.57, r2 = 0.32 (P < .001). CONCLUSIONS: Current standard multibeat acquisition protocols are unfortunately unable to prevent false impressions of optimality arising in individual patients. Personalization processes need to include distinct repeated transitions to the tested pacing configuration in addition to averaging multiple beats. The need is not only during research stages but also during clinical implementation.

Biventricular Paced QRS Area Predicts Acute Hemodynamic CRT Response Better Than QRS Duration or QRS Amplitudes.

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 (XAmpl , YAmpl , ZAmpl , and 3DAmp ) and QRS areas (XArea , YArea , ZArea , and 3DArea ) 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 (Δ) 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 ZArea (109 µVs, interquartile range [IQR]:75;135), significantly larger than XArea (22 µVs, IQR:10;57) and YArea (44 µVs, IQR:32;62, P < 0.001). Overall, QRS duration, amplitudes, and areas decrease significantly with BV pacing (P < 0.001). Of all VCG parameters, 3DAmpl , Δ3DAmpl , ZArea, ΔZArea , Δ3DArea , and ΔQRSD differentiate AHR response from nonresponse (P < 0.05). ΔZArea predicted best positive AHR (area under the curve = 0.813) and outperformed any other VCG parameter or QRSD measurement. CONCLUSION: Of all VCG parameters, reduction in QRS area, calculated in Frank's Z lead, predicts acute hemodynamic response best. This method might be an easy, noninvasive tool to guide CRT implantation and optimization.

The Incidence, Clinical Significance, and Treatment Effects of Depression in Cardiac Resynchronization Therapy Recipients.

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.

REmote SUpervision to Decrease HospitaLization RaTe. Unified and integrated platform for data collected from devices manufactured by different companies: Design and rationale of the RESULT study.

The number of patients with heart failure implantable cardiac electronic devices (CIEDs) is growing. Hospitalization rate in this group is very high and generates enormous costs. To avoid the need for hospital treatment, optimized monitoring and follow-up is crucial. Remote monitoring (RM) has been widely put into practice in the management of CIEDs but it may be difficult due to the presence of differences in systems provided by device manufacturers and loss of gathered data in case of device reimplantation. Additionally, conclusions derived from studies about usefulness of RM in clinical practice apply to devices coming only from a single company. An integrated monitoring platform allows for more comprehensive data analysis and interpretation. Therefore, the primary objective of Remote Supervision to Decrease Hospitalization Rate (RESULT) study is to evaluate the impact of RM on the clinical status of patients with ICDs or CRT-Ds using an integrated platform. Six hundred consecutive patients with ICDs or CRT-Ds implanted will be prospectively randomized to either a traditional or RM-based follow-up model. The primary clinical endpoint will be a composite of all-cause mortality or hospitalization for cardiovascular reasons within 12 months after randomization. The primary technical endpoint will be to construct and evaluate a unified and integrated platform for the data collected from RM devices manufactured by different companies. This manuscript describes the design and methodology of the prospective, randomized trial designed to determine whether remote monitoring using an integrated platform for different companies is safe, feasible, and efficacious (ClinicalTrials.gov Identifier: NCT02409225).

Ferritin as a potential biomarker of efficacy of treatment of atrial fibrillation - preliminary report.

BACKGROUND: Complex mechanisms of responsible for originating and maintaining of atrial fibrillation (AF) are involved in pathophysiology of this arrhythmia. Inflammation substantially contribute to arrhythmic remodelling of atrial tissue.The aim of the present study is to assess an applicability of ferritin and high sensitive C-reactive protein (hs-CRP) as biomarkers of atrial fibrillation and their usefulness in evaluation of efficacy of cryoablation. MATERIALS AND METHODS: The study population consisted of 40 patients who underwent first AF cryoablation procedure. The whole follow-up time was for 6 months. The efficacy of cryoablation was defined as lack of episodes of AF longer than 30 s reported either in patient's medical documentation or present in standard or Holter ECG records. Concentrations of hs-CRP (latex method ) and ferritin (immunochemical method) were determined in standard way in hospital laboratory. RESULTS: The recurrence of atrial fibrillation during follow-up was detected in 7 of 40 patients (efficacy 82.5%). Basal concentrations of hs-CRP and ferritin were significantly higher in patients who underwent ablation during AF. Ablation resulted in an increase of either hs-CRP or ferritin concentrations. After seven days, both hs-CRP and ferritin concentrations returned to basal level. The trend toward the higher concentration of hs-CRP was observed in AF recurrence subgroup in 30th and the 90th day after the procedure. Ferritin concentrations were significantly higher in recurrence subgroup after 30 and 90 days. CONCLUSION: Our results suggest that the evaluation of ferritin serum level can be a potential tool for assessment of AF treatment efficacy.

Can we rely on machines? Device-detected atrial high rates correspond well with atrial arrhythmias in cardiac resynchronization recipients.

AIMS: The aim of the study was to verify in what proportion of patients, device-detected atrial high rate (AHR) episodes are indeed atrial arrhythmias (AAs). We investigated also the reasons for inappropriate arrhythmia classification and assessed if patients with misdiagnosed arrhythmias have distinct characteristics that would help to identify them. METHODS AND RESULTS: The study population consisted of 304 consecutive patients implanted with cardiac resynchronization therapy defibrillators (CRT-Ds) and subsequently monitored via remote monitoring for a median follow-up (FU) of 30.5 months. Intracardiac electrograms of every recorded AHR episode were assessed and classified (AA vs. no AA) by two experienced cardiologists. During FU, 14 386 episodes of AHR were recorded and classified in 176 (57.9%) patients. In 89.2% of them, these episodes were true AA (94% atrial fibrillation, 62% de novo). The reasons for AHR misdiagnosis were atrial far-field signals (89.5%) and noise (10.5%). The mean per cent of day spent in AHR (54.9 vs. 5.86%; P < 0.001) and the occurrence of periods with low CRT pacing (82.8 vs. 55%; P = 0.003) were significantly higher in AA subjects than in those with misdiagnosed AHR. Episode duration of properly detected AHRs was longer than that of misdiagnosed AHRs. Higher per cent of time spent in AHR was an independent marker of appropriate arrhythmia detection [adjusted hazard ratio (HR) 1.04; P = 0.023]. CONCLUSION: Nearly two-thirds of CRT-D patients had AHR episodes within 2.5 years after implantation. Almost 90% of AHRs were indeed AA. Misdetections were caused by far-field sensing or noise. A two-step diagnostic algorithm (>9% of time spent in AHRs and episode duration >36 s) allowed for proper detection of AA with a high hit-rate and specificity.

Quality of life in cardiac resynchronization recipients: association with response and impact on outcome.

BACKGROUND: The prognostic impact of improvement in health-related quality of life (QoL) and its relation to response in cardiac resynchronization therapy (CRT) recipients remains unknown. AIM: To assess the correspondence between response to CRT and improvements in QoL and to verify if a change in QoL after pacing influences outcome in CRT patients. METHODS: Ninety-seven participants of the Triple-Site Versus Standard Cardiac Resynchronization Therapy Trial (TRUST CRT) randomized trial, in New York Heart Association class III-IV, QRS width ≥ 120 ms, left ventricular ejection fraction ≤ 35%, and significant mechanical dyssynchrony were included. Subjects filled out the Minnesota-QoL questionnaire prior to and 6 months after CRT with defibrillator (CRT-D) implantation. Data on major adverse cardiac events (MACEs: death, heart failure hospitalization, heart transplant) collected within the next 2.5 years and adjudicated blindly constituted the censoring variables. RESULTS: Within the first 6 months of resynchronization QoL improved in 81%, while worsening in 19% of patients. Clinical response, but not the echocardiographic one, was associated with improved QoL. During subsequent 2.5 years MACEs occurred in 37% of patients (23% died). Subjects without QoL improvement were significantly (both P < 0.05) more prone to experience MACE (61% vs 32%) and die (44% vs 18%) within the follow-up. Unimproved QoL increased the probability of future MACE by 2.7 times (95% confidence intervals [CI]: 1.26-5.83; P = 0.01) and death by 3.2 times (95% CI: 1.23-8.32; P = 0.02) independently from clinical and echocardiographic response. CONCLUSIONS: Clinical response, but not the echocardiographic one, was associated with improved QoL in CRT recipients. These preliminary data suggest that lack of improvement in QoL after CRT was associated with a strongly unfavorable prognosis, regardless of functional or echocardiographic response. Our results merit further studies with a larger number of patients.

Does atrial fibrillation still increase the risk of death? One-year follow-up results of the NOMED-AF study.

INTRODUCTION: Although atrial fibrillation (AF) is a well­known risk factor for ischemic stroke and hospitalization, its effect on mortality has not been clearly established. OBJECTIVES: We aimed to assess whether AF is an independent risk factor for death. A secondary objective was to evaluate the role of oral anticoagulation in the prevention of stroke and death in 1­year follow­up of patients included in the NOMED­AF (Noninvasive Monitoring for Early Detection of Atrial Fibrillation) study. PATIENTS AND METHODS: The NOMED­AF study included 3014 patients. The participants underwent continuous long­term electrocardiographic monitoring using a wearable vest for up to 30 days. The present analysis involved 2795 patients who completed the 1­year follow­up. The median (interquartile range) follow­up time was 365 (365-365) days. AF was diagnosed in 617 participants. RESULTS: Independent risk factors for death in the patients who completed the 1­year follow­up were AF, age equal to or above 65 years, and chronic kidney disease. The individuals with diagnosed AF had an almost 2­fold higher risk of death (odds ratio [OR], 1.7; 95% CI, 1.18-2.44; P <0.001) and a 2.5­fold higher risk of stroke (OR, 2.53; 95% CI, 1.41-4.44; P <0.001), as compared with those without an AF diagnosis. The participants with AF who received oral anticoagulants had an almost 5­fold lower risk of death than those who were not on anticoagulation (2.9% vs 14.2%, respectively; P <0.001). CONCLUSIONS: AF is an independent risk factor for death and cardiovascular hospitalization. The risk of death and stroke in patients with AF is significantly higher than in the patients without this arrhythmia. Oral anticoagulation in patients with AF significantly reduces the rates of death and stroke; however, its use is suboptimal in this group of patients.

Many response criteria are poor predictors of outcomes after cardiac resynchronization therapy: validation using data from the randomized trial.

AIMS: The aim of the study was to assess the predictive value for outcomes of various response criteria currently used in patients undergoing cardiac resynchronization therapy (CRT). METHODS AND RESULTS: Data from TRUST CRT randomized trial in patients with New York Heart Association (NYHA) III-IV class, QRS ≥ 120 ms, ejection fraction ≤ 35%, and mechanical dyssynchrony was analysed. Ninety-seven subjects who survived 6 months after implantation of CRT-defibrillator were classified as responders or non-responders depending on 15 criteria used in most of the previous trials. Blindly adjudicated data on major adverse cardiac events (MACEs) within 1 year after classification were used to calculate the predictive value of response criteria. After adjustment for baseline confounding variables only eight criteria were significantly predictive for future MACEs. Sensitivity and specificity ranged substantially for clinical (32-94% and 26-63%) and echocardiographic criteria (40-93% and 22-70%, respectively). The most powerful clinical predictor was >a NYHA class reduction ≥ 1 [adjusted relative risk (RR) 4.41 for non-responders; 95% confidence interval (CI) 1.75-11.04, P = 0.002], while the strongest echocardiographic predictor was a reduction in the left ventricular end-systolic index by > 15% (RR 3.49; 95% CI 1.59-7.64, P = 0.002). A combination of these two criteria did not improve the predictive value of a single parameter. Both criteria showed multiple significant interactions with baseline patients' characteristics. CONCLUSION: Only some of the commonly used response criteria predict outcome in patients undergoing CRT. The predictive value varies substantially across different criteria, with a higher sensitivity observed for the clinical parameters and a higher specificity observed for echocardiographic parameters. Combining various criteria adds little to their prognostic value. The predictive accuracy of various criteria can be different in various subgroups due to multiple interactions with baseline characteristics. CLINICALTRIALS. GOV IDENTIFIER: NCT00814840.

Diet in Patients with Myocardial Infarction and Coexisting Type 2 Diabetes Mellitus.

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.

Predictors of ventricular tachyarrhythmia in patients with implantable cardioverter-defibrillator and non-ischemic systolic heart failure.

BACKGROUND: The benefit derived from implantable cardioverter-defibrillators (ICD) in subjects with non-ischemic systolic HF (NICM) is less well-established. AIM: The study aimed to determine the incidence, predictors, and prognostic impact of ventricular arrhythmias in patients with ICD and NICM. METHODS: The study sample included 377 consecutive patients with ICD or cardiac resynchronization cardioverter-defibrillators (CRT-D, 74% of patients) and NICM implanted and monitored remotely in a university hospital. RESULTS: During the median (interquartile range [IQR]) follow-up of 1645 (960-2675) days, sustained ventricular arrhythmia occurred in 92 patients (24.4%). Of those, ventricular fibrillation (VF), ventricular tachycardia (VT), and both VT and VF occurred in 10 (10.9%), 72 (78.3%), and 10 (10.9%) patients, respectively. Patients with vs. those without ventricular arrhythmia differed concerning sex, left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD), left ventricular ejection fraction (LVEF), post-inflammatory etiology, atrial fibrillation/flutter occurrence, and supraventricular arrhythmia (SVT) other than AF/AFL during follow-up. In multivariable Cox regression, LVEDD (hazard ratio [HR], 1.05; 95% confidence interval [CI], 1.003-1.09; P = 0.03), AF/AFL (HR, 1.86; 95% CI, 1.21-2.85; P = 0.004), and SVT (HR, 1.77; 95% CI, 1.10-2.87; P = 0.02) were independent predictors of sustained VT, while AF/AFL (HR, 1.65; 95% CI, 1.07-2.56; P = 0.02) was independent predictor of VF. All-cause mortality in patients with VT/VF was significantly higher than in subjects without sustained ventricular arrhythmias (35.9% vs. 22.4%; P = 0.01). CONCLUSIONS: Ventricular arrhythmia occurred in every fourth patient with NICM and ICD during 4.5 years of observation and was associated with significantly worse prognosis than in subjects free of VT/VF. Higher LVEDD, atrial fibrillation/atrial flutter, and supraventricular tachycardia flag patients at risk of ventricular arrhythmia.

Impact of diabetes mellitus severity, treatment regimen and glycaemic control on atrial fibrillation prevalence in the Polish population aged ≥ 65.

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. 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. 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, p < 0.001), p = 0.042), body mass index (BMI; OR 1.043, 95%CI: 1.01-1.08, p = 0.027) and LDL < 100 mg/dl (OR 0.64, 95%CI: 0.42-0.97, p = 0.037) were independent risk factors for AF prevalence, while age (OR 1.45, 95%CI: 1.20-1.75, p < 0.001), LDL < 100 mg/dl (OR 0.43, 95%CI 0.23-0.82, p = 0.011), use of statins (OR 0.51, 95%CI: 0.28-0.94, p = 0.031) and HbA1c ≤ 6.5 (OR 0.46, 95%CI: 0.25-0.85, p = 0.013) were associated with silent AF prevalence. Diabetes duration, diabetic treatment pattern or metabolic control per se did not significantly impact the prevalence of AF, including silent AF detected by prospective continuous monitoring. Independent predictors of AF were age, BMI and low LDL levels, with statins and HbA1c ≤ 6.5 being additional independent predictors for silent AF.Trial registration: NCT03243474.

The effectiveness of atrial fibrillation identification using noninvasive long-term electrocardiographic monitoring system (NOMED-AF TECH).

INTRODUCTION: Although it is well­known that longer electrocardiographic (ECG) monitoring allows for detection of paroxysmal silent atrial fibrillation (SAF), it is still unknown how long the ECG monitoring should last to increase the probability of SAF diagnosis. OBJECTIVES: Our aim was to analyze ECG acquisition parameters and timing to detect SAF during the Noninvasive Monitoring for Early Detection of Atrial Fibrillation study. PATIENTS AND METHODS: The protocol assumed up to 30 days of ECG telemonitoring of each participant in order to reveal AF / atrial flutter (AFL) episodes lasting at least 30 seconds. SAF was defined as AF detected and confirmed by cardiologists in asymptomatic individuals. The ECG signal analysis was based on the results of 2974 participants (98.67%). AF/AFL episodes were registered and confirmed by cardiologists in 515 individuals, that is, 75.7% of all patients (n = 680) in whom AF/AFL diagnosis was established. RESULTS: The median monitoring time to detect the first SAF episode was 6 days (interquartile range [IQR], 1-13). Fifty percent of the patients with this type of arrhythmia were identified by 6th day (IQR, 1-13) of the monitoring, and 75% by the 13th day of the study. Paroxysmal AF was registered on average on 4th day (IQR, 1-10). CONCLUSIONS: The ECG monitoring time to detect the first episode of SAF in at least 75% of patients at risk of this arrhythmia was 14 days. Detection of 1 patient with de novo AF, SAF, or de novo SAF, required monitoring of, respectively, 17, 11, and 23 patients.

Prevalence of atrial fibrillation in the 65 or over Polish population. Report of cross-sectional NOMED-AF study.

BACKGROUND: Atrial fibrillation (AF) is the most common cardiac arrhythmia, characterized by an increased risk of thromboembolic complications that can be markedly reduced with anticoagulation. There is a paucity of studies assessing the total prevalence of AF in national populations. AIMS: To assess the nationwide prevalence of AF in a population of adults ≥65 old and to determine the impact of duration of electrocardiogram (ECG) monitoring on the number of newly detected AF episodes. METHODS: The NOMED-AF study (ClinicalTrials.gov; NCT: 0324347) was a cross-sectional study performed on a nationally representative random sample of 3014 Polish citizens 65 years or older. Final estimates were adjusted to the national population. All participants underwent up to 30 days of continuous ECG monitoring. Total AF prevalence was diagnosed based on the patient's medical records or the presence of AF in ECG monitoring. RESULTS: The prevalence of AF in the Polish population ≥65 years was estimated as 19.2% (95% confidence interval [CI], 17.9%-20.6%). This included 4.1% (95% CI, 3.5%-4.8%) newly diagnosed cases and 15.1% (95% CI, 13.9%-16.3%) previously diagnosed cases and consisted of 10.8% (95% CI, 9.8%-11.9%) paroxysmal AF and 8.4% (95% CI, 7.5%-9.4%) persistent/permanent AF. The incidence of all paroxysmal AF events as a function of ECG monitoring duration increased from 1.9% (95% CI, 1.4%-2.6%) at 24 hours to 6.2% (95% CI, 5.3%-7.2%) at 4 weeks. CONCLUSIONS: The prevalence of AF in elderly adults is higher than estimated based on medical records only. Four weeks of monitoring compared to 24-hour ECG Holter allow detection of 7-fold more cases of previously undiagnosed paroxysmal AF.

Subcutaneous implantable cardioverter-defibrillator therapy in Poland: Results of the Polish S-ICD Registry.

BACKGROUND: The use of subcutaneous implantable cardioverter-defibrillators (S-ICD) has been growing in Poland since 2014. The Polish Registry of S-ICD Implantations was run by the Heart Rhythm Section of the Polish Cardiac Society between May 2020 and September 2022 to monitor the implementation of that therapy in Poland. AIMS: To investigate and present the state-of-the-art of S-ICD implantation in Poland. METHODS: Implanting centers reported clinical data of patients undergoing S-ICD implantations and replacements, including age, sex, height, weight, underlying disease, history of pacemaker and defibrillator implantations, indications for S-ICD, electrocardiographical parameters, procedural techniques, and complications. RESULTS: Four hundred and forty patients undergoing S-ICD implantation (411) or replacement (29) were reported by 16 centers. Most patients were in New York Heart Association class II (218 patients, 53%) or I (150 patients, 36.5%). Left ventricular ejection fraction was 10%-80%, median (IQR) was 33% (25%-55%). Primary prevention indications were present in 273 patients (66.4%). Non-ischemic cardiomyopathy was reported in 194 patients (47.2%). The main reason for the choice of S-ICD were: young age (309, 75.2%), risk of infectious complications (46, 11.2%), prior infective endocarditis (36, 8.8%), hemodialysis (23, 5.6%), and immunosuppressive therapy (7, 1.7%). Electrocardiographic screening was performed in 90% of patients. The rate of adverse events was low (1.7%). No surgical complications were observed.