The implantation of AV leadless pacemaker - a case report.

In early 2020 Food and Drug Administration (FDA) approved Micra AV - a new type of leadless pacemaker with atrioventricular synchrony, to treat patients with atrio-ventricular (AV) blocks. We describe one of the first in Poland case of a patient who was implanted with Micra AV pacemaker. CASE REPORT: A 38-year-old female patient was admitted to the clinic due to the 29-seconds event of a complete AV block without an escape rhythm and was implanted with a dual chamber pacemaker without any complications. After several months she was admitted again with suspicion of ventricular perforation by the pacemaker electrode and underwent a replacement procedure of both pacemaker's leads. Nevertheless, one week later the patient developed a fever with significantly elevated inflammatory markers. The blood cultures were negative but in the transesophageal echocardiography features of cardiac device-related infective endocarditis were observed. Empirical antibiotic therapy was administered, and the device was removed. The Heart Team qualified the patient for the implantation of a MicraTM AV leadless pacemaker. The procedure was performed without any complications and the device was implanted to the right ventricle. All parameters were correct, and the patient was discharged. CONCLUSIONS: Micra AV may be a feasible and safe option for young patients with paroxysmal AV block after device-related complications.

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.

Therapeutic hypothermia and postreperfusion myocardial injury in myocardial infarction.

Myocardial infarction is one of the main causes of death worldwide. Since the introduction of primary percutaneous coronary intervention (PPCI), the rate of patients who die of a myocardial infarction or suffer from numerous complications afterwards has significantly decreased. During PPCI, the patient sustains postreperfusion myocardial injury, which entails an extension of the myocardial infarct size related to ischemia. Research on the ways of limiting this phenomenon has been carried out for years. One of the investigated methods is hypothermia. The first animal studies have yielded promising results. The application of hypothermia has been proved to reduce the myocardial injury size provided that the cooling commenced before reperfusion. Moreover, the trial conducted by Götberg M. et al. showed a significant reduction of microvascular obstruction (MVO) in pigs subjected to hypothermia before reperfusion. MVO was assessed via ex vivo magnetic resonance imaging. The conducted randomized clinical trials have shown the possibility of applying mild hypothermia in conscious patients without causing significant complications. In the presented trials, hypothermia was induced and maintained using an intravascular catheter inserted into the inferior vena cava, cold saline solution infusions into peripheral veins or directly into the coronary arteries or via peritoneal hypothermia. The myocardial injury size was assessed via magnetic resonance imaging (MRI) or single photon emission computed tomography (SPECT). Despite the promising results obtained by Young-Sheng Wang et al., who applied selective intracoronary hypothermia and the myocardial infarct size (IS/MaR) was significantly reduced (p=0.022), it has not been unambiguously confirmed yet that hypothermia is effective as an adjunctive therapy for revascularization in myocardial injury size reduction during a myocardial infarction.

The first successful implantation of an intravenous AAIR pacemaker into autologous extracardiac lateral tunnel Fontan in the child.

Patients with a single ventricle have complex anatomy that requires staged palliation which is usually the Fontan procedure. This procedure has undergone a lot of modifications to improve hemodynamics. Despite these efforts, sinus node dysfunction (SND) and bradyarrythmias are still common complications after Fontan operation, therefore there is a need of pacemakers implantation. Unfortunately, the most frequent technique of creating Fontan cannale - the extracardiac lateral tunnel makes the transvenous access to the atrium difficult or impossible to achieve. We report a case of successful implantation of an endocardial atrial lead for SND in patient with an extracardiac autologous Fontan tunnel.

[Vest recorder used in diagnostics of occasionally occurring supraventricular tachycardia nearby sinus node - a case report]. / Rejestrator koszulkowy w diagnostyce sporadycznie wystepujacego czestoskurczu okolozatokowego ­ opis przypadku.

Symptoms such as palpitations, fainting, dizziness and unexplained loss of consciousness are often notified by patients in clinical practice. Cardiological causes of these ailments could be various, inter alia, atriaventricular conduction disorders, supraventricular arrythmias or more life-threatening ventricular arrythmias. Diagnostics of these disorders includes a series of basic non-invasive research and more advanced specialistic methods. Presented case report shows problems of arrythmias diagnostics and imperfections of avaible methods.

[The neuroprotective effect of mild therapeutic hypothermia after out-of-hospital cardiac arrest with successful reanimation - a case report]. / Neuroprotekcyjne dzialanie lagodnej hipotermii terapeutycznej po pozaszpitalnym zatrzymaniu krazenia ze skuteczna reanimacja - opis przypadku.

The use of mild therapeutic hypothermia (MTH) in adult patients remaining in a coma following cardiac arrest, regardless of its mechanism and location, is recommended by the European Resuscitation Council. The study presents a case of a 52-year-old man in whom MTH was used following successfully resuscitated out-of- hospital sudden cardiac arrest caused by ventricular fibrillation. On the basis of this case it was indicated that the use of low temperatures may be an effective method of neuroprotective treatment since such activity is compatible with later observed great possibility of the brain to compensate and with the maintenance of brain plasticity which is crucial for neuropsychological rehabilitation.

Interictal heart rate in patients with epilepsy.

INTRODUCTION: Electrocardiographic abnormalities in patients with epilepsy are related to the presence of discharges in central autonomic structures and the effect of antiepileptic drugs. These patients are at risk for sudden unexpected death, and cardiac arrhythmias are one of the most probable causes related to it. THE AIM: The heart rate (HR) assessment recorded on electrocardiography (ECG) in the interictal period in patients with newly diagnosed and previously treated epilepsy, depending on the type of changes in electroencephalography (EEG) and the treatment option. MATERIAL AND METHODS: Fifty patients with epilepsy were enrolled in the study: 22 comprised a non-treated patient (NTP) group with newly diagnosed epilepsy and 28 comprised a treated patient (TP) group that had been treated for more than 2 years. Resting ECG and EEG were performed in all patients. RESULTS: A significantly higher HR was recorded in the TP group compared to the NTP group (80±13 vs 67±15 bpm, p=0.00006). The tendency to higher HR was observed in polytherapy patients, carbamazepine patients and in patients with a focus in the right hemisphere. CONCLUSIONS: There is a relationship between the presence of the disorders related to bioelectric activities of the brain and the heart, therefore the ECG should be periodically monitored in epileptic patients.

Interictal heart rate in patients with epilepsy.

INTRODUCTION: Electrocardiographic abnormalities in patients with epilepsy are related to the presence of discharges in central autonomic structures and the effect of antiepileptic drugs. These patients are at risk for sudden unexpected death, and cardiac arrhythmias are one of the most probable causes related to it. THE AIM: The heart rate (HR) assessment recorded on electrocardiography (ECG) in the interictal period in patients with newly diagnosed and previously treated epilepsy, depending on the type of changes in electroencephalography (EEG) and the treatment option. MATERIAL AND METHODS: Fifty patients with epilepsy were enrolled in the study: 22 comprised a non-treated patient (NTP) group with newly diagnosed epilepsy and 28 comprised a treated patient (TP) group that had been treated for more than 2 years. Resting ECG and EEG were performed in all patients. RESULTS: A significantly higher HR was recorded in the TP group compared to the NTP group (80±13 vs 67±15 bpm, p=0.00006). The tendency to higher HR was observed in polytherapy patients, carbamazepine patients and in patients with a focus in the right hemisphere. CONCLUSIONS: There is a relationship between the presence of the disorders related to bioelectric activities of the brain and the heart, therefore the ECG should be periodically monitored in epileptic patients.

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.

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.

Defibrillator implantation early after myocardial infarction.

BACKGROUND: The rate of death, including sudden cardiac death, is highest early after a myocardial infarction. Yet current guidelines do not recommend the use of an implantable cardioverter-defibrillator (ICD) within 40 days after a myocardial infarction for the prevention of sudden cardiac death. We tested the hypothesis that patients at increased risk who are treated early with an ICD will live longer than those who receive optimal medical therapy alone. METHODS: This randomized, prospective, open-label, investigator-initiated, multicenter trial registered 62,944 unselected patients with myocardial infarction. Of this total, 898 patients were enrolled 5 to 31 days after the event if they met certain clinical criteria: a reduced left ventricular ejection fraction (< or = 40%) and a heart rate of 90 or more beats per minute on the first available electrocardiogram (ECG) (criterion 1: 602 patients), nonsustained ventricular tachycardia (> or = 150 beats per minute) during Holter monitoring (criterion 2: 208 patients), or both criteria (88 patients). Of the 898 patients, 445 were randomly assigned to treatment with an ICD and 453 to medical therapy alone. RESULTS: During a mean follow-up of 37 months, 233 patients died: 116 patients in the ICD group and 117 patients in the control group. Overall mortality was not reduced in the ICD group (hazard ratio, 1.04; 95% confidence interval [CI], 0.81 to 1.35; P=0.78). There were fewer sudden cardiac deaths in the ICD group than in the control group (27 vs. 60; hazard ratio, 0.55; 95% CI, 0.31 to 1.00; P=0.049), but the number of nonsudden cardiac deaths was higher (68 vs. 39; hazard ratio, 1.92; 95% CI, 1.29 to 2.84; P=0.001). Hazard ratios were similar among the three groups of patients categorized according to the enrollment criteria they met (criterion 1, criterion 2, or both). CONCLUSIONS: Prophylactic ICD therapy did not reduce overall mortality among patients with acute myocardial infarction and clinical features that placed them at increased risk. (ClinicalTrials.gov number, NCT00157768.)

Implantation feasibility, procedure-related adverse events and lead performance during 1-year follow-up in patients undergoing triple-site cardiac resynchronization therapy: a substudy of TRUST CRT randomized trial.

INTRODUCTION: This substudy was to assess implantation feasibility and long-term safety of triple-site resynchronization therapy (CRT) in a series of consecutive patients included in a randomized trial. METHODS AND RESULTS: One hundred consecutive patients enrolled into Triple-Site Versus Standard Cardiac Resynchronization Therapy Randomized Trial were analyzed. Eligibility criteria included NYHA class III-IV, sinus rhythm, QRS ≥ 120 milliseconds, left ventricular ejection fraction ≤35%, and significant mechanical dyssynchrony. Patients were randomized in a 1:1 ratio to conventional or triple-site CRT with defibrillator-cardioverter. After 12 months of resynchronization 30% of patients with conventional resynchronization and 12.5% with triple-site CRT were in NYHA functional class III or IV (P < 0.05). Implantation of triple-site systems was significantly longer (median 125 minutes vs 96 minutes; P < 0.001), with higher fluoroscopic exposure, especially in patients with very enlarged left ventricle or pulmonary hypertension. Implantation success-rate was similar in the triple-site and conventional group (94% vs 98%; P = NS); however, additional techniques had to be used in a greater proportion of the triple-site patients (33.3% vs 16%; P < 0.05). Long-term lead performance tests revealed significantly higher pacing threshold and lower impedance in the triple-site group. The 1-year incidence of serious, CRT-related adverse events was similar in triple-site and conventional group (20.8% vs 30%; P = NS). CONCLUSIONS: Triple-site CRT is associated with more pronounced functional improvement than standard resynchronization. This form of pacing is equally safe and feasible as the conventional CRT. However, triple-site procedure is more time-consuming, associated with higher radiation exposure and the need to use additional techniques. Triple-site resynchronization is associated with less favorable electrical lead characteristics.

The prognostic value of different glucose abnormalities in patients with acute myocardial infarction treated invasively.

BACKGROUND: Diabetes (DM) deteriorates the prognosis in patients with coronary heart disease. However, the prognostic value of different glucose abnormalities (GA) other than DM in subjects with acute myocardial infarction (AMI) treated invasively remains unclear. AIMS: To assess the incidence and impact of GA on clinical outcomes in AMI patients treated with percutaneous coronary intervention (PCI). METHODS: A single-center, prospective registry encompassed 2733 consecutive AMI subjects treated with PCI. In all in-hospital survivors (n = 2527, 92.5%) without the history of DM diagnosed before or during index hospitalization standard oral glucose tolerance test (OGTT) was performed during stable condition before hospital discharge and interpreted according to WHO criteria. The mean follow-up period was 37.5 months. RESULTS: The incidence of GA was as follows: impaired fasting glycaemia - IFG (n = 376, 15%); impaired glucose tolerance - IGT (n = 560, 22%); DM (n = 425, 17%); new onset DM (n = 384, 15%); and normal glucose tolerance - NGT (n = 782, 31%). During the long-term follow-up, death rate events for previously known DM, new onset DM and IGT were significantly more frequent than those for IFG and NGT (12.3; 9.6 and 9.4 vs. 5.6 and 6.4%, respectively, P < 0.05). The strongest and common independent predictors of death in GA patients were glomerular filtration rate < 60 ml/min/1,73 m^2 (HR 2.0 and 2.8) and left ventricle ejection fraction < 35% (HR 2.5 and 1.8, all P < 0.05) respectively. CONCLUSIONS: Glucose abnormalities are very common in AMI patients. DM, new onset DM and IGT increase remote mortality. Impaired glucose tolerance bears similar long-term prognosis as diabetes.

The significance of heart rate turbulence in predicting major cardiovascular events in patients after myocardial infarction treated invasively.

INTRODUCTION: The role of heart rate turbulence (HRT) related to baroreflex sensitivity in predicting mortality after myocardial infarction (MI) has been confirmed by several investigators. However, the significance of HRT in predicting major adverse cardiovascular events (MACE) following acute MI is unknown. PURPOSE: To analyze the prognostic value of HRT and other independent risk factors associated with autonomic regulation of MACE. METHODS: HRT was assessed based on 24-hour Holter recordings in 500 patients (pts) with acute MI treated invasively (352 M, aged 60.58 years). Turbulence onset (TO,%), slope (TS, ms/RR interval) and timing (TT) were calculated. TO ≥ 0, TS ≤ 2.5 and TT ≥ 10 were considered abnormal; classic and own categories were defined. Time domain heart rate variability (HRV) parameters were also calculated. Within 30.1 ± 15.1 months of follow-up, MACE occurred in 116 pts. RESULTS: Abnormal TO, TS, and TT were significantly more frequent in patients with MACE (P < 0.05 for each parameter, classic and own categories). In long-term follow-up, the largest differences in MACE were observed in patients with own category comprising abnormal TO, TS, and TT. Combining HRT parameters with SDNN (total HRV index) augmented their predictive value. Independent risk factors for MACE were TT, SDNN and rMSSD (a parasympathetic activity index) (HR 2.44, 1.71 and 1.69 respectively; P < 0.05). CONCLUSION: Abnormal HRT distinguishes patients at risk of MACE after MI. Own category encompassing three abnormal HRT parameters best differentiates patients at risk of MACE. Turbulence timing is a strong independent risk factor for MACE following MI.