Clinical and subclinical acute brain injury caused by invasive cardiovascular procedures.

Over the past 50 years, the number and invasiveness of percutaneous cardiovascular procedures globally have increased substantially. However, cardiovascular interventions are inherently associated with a risk of acute brain injury, both periprocedurally and postprocedurally, which impairs medical outcomes and increases health-care costs. Current international clinical guidelines generally do not cover the area of acute brain injury related to cardiovascular invasive procedures. In this international Consensus Statement, we compile the available knowledge (including data on prevalence, pathophysiology, risk factors, clinical presentation and management) to formulate consensus recommendations on the prevention, diagnosis and treatment of acute brain injury caused by cardiovascular interventions. We also identify knowledge gaps and possible future directions in clinical research into acute brain injury related to cardiovascular interventions.

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.

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.

Rationale and design of a randomized clinical trial evaluating the efficacy of mechanical neuroprotection in reducing the risk of silent brain infarcts associated with percutaneous left atrial appendage closure: study protocol for a LAAC-SBI trial.

BACKGROUND: Left atrial appendage closure (LAAC) procedures prevent cardioembolic stroke in patients with atrial fibrillation who have contraindications to oral anticoagulant medications. However, these procedures carry certain risks of peri-procedural complications. One such complication is silent brain infarcts (SBI), which can lead to cognitive impairment and mood disturbances. The implementation of mechanical neuroprotection systems during LAAC procedures may reduce the risk of SBI and associated cognitive and mood disorders. METHODS: The LAAC-SBI trial is a prospective, multicenter, randomized, and double-blind interventional study. The study aims to enroll a total of 240 patients, with 120 patients allocated to each group. The study group will evaluate the use of the Sentinel CPS during LAAC, while the control group will undergo LAAC procedures without the Sentinel CPS. The primary endpoint of the study is the number of new SBIs or stroke foci detected by diffusion-weighted magnetic resonance imaging (DW MRI). Secondary endpoints include deterioration of cognitive function, development of dementia syndrome, and occurrence of depressive disorders. These endpoints will be assessed using questionnaire tools such as the Montreal Cognitive Assessment (MoCA), Trail Making Test (TMT), Controlled Oral Word Association Test (COWAT), and Hospital Anxiety and Depression Scale (HADS). The observational period for patients in the study is 2 years. DISCUSSION: If the study demonstrates a favorable outcome with reduced incidence of SBI and improved cognitive and mood outcomes in patients receiving cerebral protection devices during LAAC, it will have significant implications for clinical management standards. This would support the use of neuroprotection devices not only for LAAC but also in procedures such as atrial fibrillation ablation or transcatheter mitral valve interventions, where the risk of embolic events and subsequent brain injury may also be present. TRIAL REGISTRATION: ClinicalTrials.gov NCT05369195. Registration on 11.05.2022.

Predictive factors of left ventricular ejection fraction improvement after myocardial infarction treated invasively.

Introduction: One indication for the implantation of a cardioverter-defibrillator is a reduction in the left ventricular ejection fraction (LVEF) ≤ 35%. However, in certain patients following an acute myocardial infarction (AMI) a gradual improvement in LVEF has been observed. The factors determining this increase in LVEF have not been conclusively determined. Aim: To ascertain the independent predictors associated with the improvement of LVEF in patients following AMI who underwent invasive treatment, while observing their progress over a 6-month follow-up period. Material and methods: Among 665 patients with AMI, a population with LVEF ≤ 35% was selected. After 6 months, a follow-up echocardiogram was performed. Further analysis compared patients with at least 5% improvement in LVEF (Group I) with those without an increase (Group II). Results: Group I consisted of 34 individuals out of 80 patients (43%) with LVEF ≤ 35%. The factors linked to a reduced probability of LVEF improvement were: higher levels of cardiac troponin T (cTnT) (OR 0.841 for 1 ng/ml increase in cTnT, CI 0.715-0.989; p = 0.037), presence of diabetes mellitus (OR = 0.217, 95% CI: 0.058-0.813, p = 0.023) and moderate or severe mitral regurgitation (OR = 0.178, 95% CI: 0.053-0.597; p = 0.005). Conclusions: The study findings indicate that the presence of severe or moderate mitral regurgitation is the most significant factor contributing to the lack of LVEF improvement following AMI. Moreover, the extent of myocardial damage, as indicated by elevated cTnT values, along with compromised adaptation to hypoxia in patients with diabetes, are identified as independent factors associated with reduced chances of an increase in LVEF.

The prognostic impact of therapeutic hypothermia after a sudden cardiac arrest in the course of myocardial infarction.

BACKGROUND: Mild therapeutic hypothermia (MTH) is one of the treatment methods recommended in post-sudden cardiac arrest (SCA) patients who remain unconscious after cardiopulmonary resuscitation. The present study aimed at assessing the prognostic impact of intravascular MTH on invasively treated patients with an acute myocardial infarction complicated by SCA. METHODS: The presented data were collected via a single-center retrospective analysis of the hospitalization and follow-up of 54 patients with post-myocardial infarction complicated by SCA. The patients were treated in the years 2014-2020 and the average follow-up period was 1141 ± 163 days. The population was divided into two groups: 28 patients treated with MTH (a therapeutic hypothermia [TH] group) and 26 patients treated without MTH (a non-TH group). RESULTS: The results indicate a trend toward improved in-hospital prognosis in the TH group, but the differences did not reach statistical significance: TH 25.0% vs. non-TH 34.5%, p = 0.554. An additional analysis of younger patients (under 60 years of age) revealed no significant differences between the TH and non-TH subgroups concerning in-hospital survival (in-hospital mortality rate: TH 6.7% vs. non-TH 30.0%, p = 0.267). Still, TH patients aged < 60 achieved a significantly better rate of follow-up survival (p = 0.041). The older (≥ 60) patient group showed no in-hospital mortality rate differences (TH 46.2% vs. non-TH 37.5%, p = 0.638). However, in-hospital bleeding frequency was significantly higher in patients aged ≥ 60 from the hypothermia group (TH 50.0% vs. non-TH 6.7%, p = 0.011). CONCLUSIONS: Intravascular MTH may improve the follow-up prognosis in patients aged < 60 with SCA in the early phase of myocardial infarction.

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.

Comparison of the everolimus-eluting bioresorbable vascular scaffold versus the everolimus-eluting metallic stent in real-world patients with ST-segment elevation myocardial infarction.

INTRODUCTION: Despite the withdrawal of the ABSORB bioresorbable vascular scaffold (BVS) from clinical use, continuous observation of BVS-treated patients is necessary. In the vast majority of clinical trials, patients with ST-segment elevation myocardial infarction (STEMI) were excluded from the analysis. AIM: To compare the early and long-term outcomes of the BVS with the everolimus-eluting metallic stent (EES) in patients with STEMI. MATERIAL AND METHODS: Consecutive patients treated with BVS or EES in our center were screened. For analysis, only patients with STEMI were enrolled. The primary endpoint was a comparison of the target lesion failure at 12 and 24 months. The secondary endpoints encompass occurrence of the patient-oriented cardiovascular endpoint (PoCE), stent thrombosis (ST), device, and procedural success. RESULTS: Between 2012 and 2016, 2,137 patients were hospitalized for STEMI. Of these, 123 patients received the BVS (163 scaffolds; 151 lesions), whereas in 141 patients the EES (203 stents; 176 lesions) was implanted. The median follow-up was 931 ±514 days. The primary endpoint at 12 months occurred in 9.7% in the BVS group and in 8.5% in the EES group (hazard ratio (HR) = 2.61; 95% confidence interval (CI): 0.90-7.56; p = 0.076). At 24 months the incidence of the primary endpoint was 15.2% in the BVS group and 14.9% in the EES group (HR = 2.46; 95% CI: 0.85-7.07; p = 0.095). The rates of PoCE, ST, device, and procedural success were also comparable in both groups. CONCLUSIONS: STEMI patients treated with the BVS showed statistically similar rates of primary and secondary endpoints compared with the EES.

Risk stratification for complex ventricular arrhythmia complicating ST-segment elevation myocardial infarction.

OBJECTIVES: The primary aim of the study was to evaluate risk factors for ventricular fibrillation/sustained ventricular tachycardia (VF/VT) and to develop the risk score for prediction of VF/VT in patients with ST-segment elevation myocardial infarction (STEMI) treated invasively. The secondary aim was to assess the effect of VF/VT on mortality depending on timing of arrhythmia. PATIENTS AND METHODS: We analyzed 4363 consecutive patients with STEMI treated invasively. Among them, 163 patients with pre-reperfusion arrhythmia were excluded from the study. Group ventricular arrhythmias (VA) encompassed patients with VF/VT - those with reperfusion-induced arrhythmia were included into group VA1, whereas group VA2 consisted of patients with postreperfusion arrhythmia. The control group comprised patients free of VF/VT. RESULTS: VF or VT occurred in 313 (7.45%) patients - group VA1 encompassed 103 (32.9%) and group AV2 210 (67.1%) patients. Cardiogenic shock on admission [hazard ratio (HR) 3.5], new-onset atrial fibrillation (HR 2.1), incomplete revascularization (HR 1.7), prior myocardial infarction (HR 1.6) and symptom-to-balloon time more than 3 h (HR 1.3) were the independent predictors of VF/VT occurrence. In group VA2, the in-hospital and long-term mortality were 4- and 1.5-fold higher than in the arrhythmia-free population (20.5 vs. 4.5% and 36.2 vs. 22.6%, respectively; P<0.001). On the contrary, in group VA1, the long-term mortality was not significantly higher compared with the control group (26.2 vs. 22.6%; P=NS), whereas in-hospital mortality was almost three-fold increased (12.5 vs. 4.5%, respectively; P<0.001). CONCLUSION: The risk score based on simple clinical parameters might be useful for risk stratification for VF/VT in patients with STEMI. The predictive value of VF/VT was strongly dependent on timing of arrhythmia.

Prognostic Significance of Complex Ventricular Arrhythmias Complicating ST-Segment Elevation Myocardial Infarction.

The aim of the study was to assess the clinical significance of complex ventricular arrhythmias (VAs) (sustained ventricular tachycardia [sVT] and ventricular fibrillation [VF]) in patients with ST-segment elevation myocardial infarction (STEMI) depending on timing of arrhythmia. We analyzed 4,363 consecutive patients with STEMI treated invasively between 2004 and 2014. The median follow-up was 69.6 months (range: 0 to 139.8 months). The study population was divided into 2 main groups; VA group encompassed 476 patients (10.91%) with VAs, whereas 3,887 subjects (89.09%) without VT or VF were included into the control group. In VA population, prereperfusion VA (34.24%; n = 163) was the most common arrhythmia, whereas reperfusion-induced, early postreperfusion, and late postreperfusion VAs were diagnosed in 103 (21.64%), 103 (21.64%), and 107 (22.48%) patients, respectively. Every type of sVT or VF complicating STEMI portended significantly worse in-hospital prognosis, however a late onset arrhythmia was associated with the highest (over fivefold) and reperfusion-induced VA with the lowest (less than threefold) increase in mortality risk compared with the control group. On the contrary, long-term mortality was significantly increased only in subjects with late postreperfusion and prereperfusion VAs compared with VA-free population (43.93% and 36.81%, respectively vs 22.58%; p <0.001). Apart from cardiogenic shock on admission, late postreperfusion (hazard ratio 3.39) and prereperfusion VAs (hazard ratio 2.76) were the strongest independent predictors of death in the analyzed population. In conclusion, 1 in 10 patients with STEMI treated invasively was affected by sVT or VF. The clinical impact of VAs was strongly dependent on timing of arrhythmia.

Early and long-term outcomes of bioresorbable vascular scaffolds in the treatment of patients with coronary artery disease in real-world clinical practice - insights from the ZABRZE-BVS registry.

INTRODUCTION: Randomized trials have proven the feasibility and safety of the bioresorbable vascular scaffold (BVS) in selected populations of patients. Data concerning the results of BVS in "real-world" registries with an appropriate sample size are limited. AIM: Assessment of early- and long-term outcomes of patients undergoing bioresorbable scaffold implantation in an all-comers population of the ZABRZE-BVS registry. MATERIAL AND METHODS: The ZABRZE-BVS registry is a prospective registry including consecutive patients treated in the period 2013-2016 with the intention to implant a BVS (ABSORB, Abbott Vascular, Santa Clara, California). The primary endpoint was occurrence of the 12- and 24-month device-oriented composite endpoint (DoCE) defined as cardiac death, target-vessel myocardial infarction (TV-MI) or target lesion revascularization (TLR). The secondary endpoint includes occurrence of patient-oriented composite endpoint (PoCE) at 12 and 24 months, device (lesion basis) and procedural success (patient basis). RESULTS: A total of 456 patients during 467 procedures received 588 scaffolds in 563 lesions. Of note, 25.4% of patients presented with diabetes mellitus and 62.3% had an acute coronary syndrome. In QCA analysis, 78.7% of patients had type B2/C lesions, minimal lumen diameter was 0.78 ±0.54 mm, whereas post-procedural acute lumen gain was 1.61 ±0.61 mm. Median follow-up was 781 days. The cumulative rate of DoCE was 6.7% at 12 months and 12.2% at 24 months. Rates of 12- and 24-month PoCE were 12.4% and 20.1%, respectively. The percentage of device success was 98.7%, while the procedural success rate was 96.9%. CONCLUSIONS: The Absorb BVS was successfully and safely implanted in an unselected group of patients. Scaffold thrombosis developed predominantly in patients with acute coronary syndrome (ACS).

Gender-related differences in long-term outcome among high-risk patients with myocardial infarction treated invasively.

INTRODUCTION: Treating acute myocardial infarction (AMI) with percutaneous coronary intervention (PCI) has an impact on improving long-term outcome. However, patients with other comorbidities are challenging, and are considered as a high-risk population. AIM: To assess gender-related differences in long-term prognosis after AMI among high-risk patients. MATERIAL AND METHODS: The single-center registry encompassed 4375 AMI patients treated with PCI. The following high-risk groups were selected: age > 70 group (n = 1081), glomerular filtration rate (GFR ) < 60 group (n = 848), diabetes mellitus (DM) group (n = 782), low ejection fraction (EF) group (n = 560) defined as EF < 35%, and incomplete coronary revascularization (ICR) group (n = 2008). Within each group, comparative analysis of long-term mortality with respect to gender and age was performed. RESULTS: There were no significant differences in long-term mortality with respect to gender among groups with age > 70 (29.0% vs. 30.3%) and GFR < 60 (37.2% vs. 42.3%) (both p = NS respectively for men vs. women). In the DM group (24.8% vs. 30.8%; p = 0.06) and EF < 35% group (36.3% vs. 44.5%; p = 0.07) there was a trend towards significance. The ICR group showed a higher mortality rate with respect to gender (19.7% vs. 27.3%; p < 0.001). Differences in survival assessed by the log-rank test were significant among ICR and EF < 35% groups. CONCLUSIONS: Female gender is related to higher long-term mortality among high-risk groups, but a statistically significant difference was observed only in patients with ICR and those with EF < 35%. Female gender may be associated with worse prognosis in diabetic patients, but it needs evaluation. However, worse prognosis in women was not independent and was associated mainly with other comorbidities and worse clinical characteristics.

Significance of Atrial Fibrillation Complicating ST-Segment Elevation Myocardial Infarction.

The aim of the present study is to assess the clinical impact of atrial fibrillation (AF) in patients with ST-segment elevation myocardial infarction (STEMI) complicated by new-onset AF depending on STEMI location and timing of arrhythmia. We analyzed 4,363 consecutive STEMI patients treated invasively. Finally, 4,099 subjects were included into further analysis, as 264 patients were excluded because of previous AF history. In total, 1,800 (43.9%) subjects with anterior infarction were included into Group 1, whereas Group 2 encompassed 2,299 (56.1%) patients with nonanterior infarction. Subsequently, both groups were divided into patients with new-onset AF (AF Group 1 and 2, respectively) and without AF (Control Group 1 and 2). New-onset AF was recognized in 225 patients (5.5%): 96 (5.3%) with an anterior wall infarction (AF Group 1) and 129 (5.6%) with a nonanterior wall infarction (AF Group 2). The incidence of early-onset arrhythmia (within 24 hours after admission) was significantly higher in AF Group 2 than in AF Group 1: 71.3% versus 35.4% (p <0.001). In Group 1, both early- and late-onset AFs were associated with significantly increased in-hospital mortality compared with AF-free population (17.7% and 27.4%, respectively vs 6.3%; p <0.05), whereas in Group 2, in-hospital mortality was increased only in subjects with late-onset AF compared with AF-free population (13.5% vs 4.2%, p <0.05). New-onset AF was the independent predictor of death only in Group 1 (hazard ratio 2.16) and this effect was stronger for late-onset AF (hazard ratio 2.86). In conclusion, 1 in 20 patients with STEMI treated invasively was affected by new-onset AF. The predictive value of new-onset AF was strongly related with STEMI location and timing of arrhythmia.

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.

Device-related infective endocarditis in cardiac resynchronization therapy recipients - Single center registry with over 2500 person-years follow up.

AIM: To assess incidence, predisposing factors and outcomes of cardiac device-related infective endocarditis (CDRIE) in patients undergoing cardiac resynchronization therapy (CRT). METHODS AND RESULTS: 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 cardioverter­defibrillator [ICD], respectively). During the median follow-up (FU) of 1207 days (range: 256­2664) 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 1.93­9.57; and HR 2.43, 95%CI 1.32­4.49, respectively). In the second model (including all differences with P < 0.2) up-grade from ICD (HR 4.36, 95%CI 1.96­9.69), higher NYHA class (HR 2.04, 95%CI 1.11­3.75), hypertrophic cardiomyopathy (HR 5.85, 95% CI 1.46­23.52), lower baseline hemoglobin level (HR 0.68, 95%CI 0.50­0.94) and chronic obstructive pulmonary disease (HR 2.46, 95%CI 1.05­5.77) 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%, P < 0.001), and 50% of patients with CDRIE died during index hospitalization. CONCLUSIONS: 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.

Long-term prognosis is related to mid-term changes of glucometabolic status in patients with acute myocardial infarction treated invasively.

BACKGROUND: Glucometabolic status (GS) in patients with acute myocardial infarction (AMI) has an impact on prognosis, but it may change over time. AIM: To evaluate the prognosis after AMI treated invasively with respect to changes in GS assessed by oral glucose tolerance test at discharge and at mid-term follow-up visit (FU-visit). METHODS: Glucometabolic status was assessed by two-hour post-load glycaemia and defined as abnormal glucose tolerance (AGT) or normal glucose tolerance (NGT). Out of 454 in-hospital AMI survivors, 368 (81%) patients completed an FU-visit and were divided into four groups with respect to GS at discharge and FU-visit: group 1 - AGT at discharge and FU-visit (n = 101); group 2 - AGT at discharge and NGT at FU-visit (n = 48); group 3 - NGT at discharge and AGT at FU-visit (n = 114); and group 4 - NGT at discharge and FU-visit (n = 105). All-cause mortality was compared between groups with log-rank test. RESULTS: Median time from AMI to FU-visit was seven months. Median remote follow-up duration after AMI was 31 months. Two-hour post load glycaemia was significantly higher in patients with confirmed AGT at FU-visit than in other groups. Mortality was higher in group 1 (11.9%) than in group 2 (2.1%; p = 0.034) and group 4 (2.9%; p = 0.009). Mortality rates between group 2 and 4 were similar (2.1% vs. 2.9%; p = 0.781). There was no significant difference in mortality between group 1 and group 3 (11.9% vs. 6.1%; p = 0.114). Mortality in group 3 was over two-fold higher than in group 4; however, this difference was statistically non-significant (6.1% vs. 2.9%; p = 0.247). CONCLUSIONS: Prognosis for patients with confirmed AGT was unfavourable; however, patients with AGT at discharge, in whom GS improved, had similar mortality to subjects with persistent NGT. The major clinical implication from this study is the finding that reassessment of GS by repeated oral glucose tolerance test has significant prognostic value and makes initial risk stratification performed at discharge more reliable.

Do we need to monitor the percentage of biventricular pacing day by day?

BACKGROUND: 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%. METHODS AND RESULTS: Prospective, single-centre registry encompassed 304 consecutive heart failure patients with cardiac resynchronization therapy defibrillators (CRT-D). Patients with 24-h episodes of CRT% loss<95% 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%; p<0.001). 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, p<0.001), 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; p<0.001). Mortality rose by 1.3 and 49% with every additional day and quartile of CRT% loss, respectively. CONCLUSIONS: Daily remote monitoring allows one to detect 24-h episodes of CRT% loss<95% 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.

Day by day telemetric care of patients treated with cardiac resynchronisation therapy: first Polish experience.

BACKGROUND: Due to the recent rapid increase in the number of patients implanted with pacemakers, cardioverter-defibrillators (ICD), and cardiac resynchronisation therapy devices (CRT), conventional monitoring at specialist clinics is becoming increasingly difficult. The development of technology has enabled remote device monitoring with the use of teletransmission systems. AIM: To assess the effectiveness of transmission and the possibility of using telemetric data for further clinical management of patients with heart failure (HF) treated with CRT-D. METHODS: The analysis included 305 consecutive patients with chronic HF, New York Heart Association functional classes II-IV, treated with the use of CRT-D by Biotronik or Medtronic in the years 2006-2012. The patients received transmitters, enabling the remote monitoring of the implanted device from the patients' houses. Scheduled reports were automatically sent every month. The triggers for pre-specified emergency alert transmissions were as follows: ventricular tachycardia (VT) or ventricular fibrillation (VF) episodes, CRT-D intervention, ventricular extrasystoles > 110/h, any episode of atrial fibrillation (AF), atrial flutter (AFL) or supraventricular tachycardia, mean heart rate (HR) during, mean 24-h HR, CRT pacing < 95%, Elective Replacement Indicator, or End Of Service and device malfunction. The all-cause mortality of the study population has been assessed at the end of the follow-up period (mean of 20.5 months). RESULTS: Devices manufactured by Biotronik were provided to 71% of the study population, while 29% received devices by Medtronic. In 97.3% of cases, the monitors were wireless, fully automatic, and capable of immediate data transmission whenever a pre-specified alert notification was fulfilled. The analysis of long-term outcomes revealed that all-cause mortality of the whole study population was 13%. The effectiveness of report transmission was 98%. During follow-up a total of 31,198 transmissions were received and analysed, which constituted, on average, 4.9 transmissions per patient per month. Among analyses, 30% were reports generated by scheduled remote follow-ups, and 70% were caused by unscheduled device alerts. Correct functioning of the system was confirmed; the quality of the received data was 100%. In 63.9% of patients, decisions based on the information obtained from telemonitoring reports were made to modify the therapy, refer the patients to cardiology or electrophysiology clinics, or hospitalise them urgently. The most common medical reaction was device reprogramming (46.8%). Pharmacotherapy was modified in 33.7% of patients: beta-blocker dose increase (25.9%), anticoagulant treatment inclusion (15.7%), amiodarone inclusion (1.9%), or digoxin inclusion (4.5%). The remaining medical responses were referring patients for atrioventricular junction ablation (8.1%), VT ablation (2.9%), or AF/AFl ablation (1.6%). CONCLUSIONS: Remote monitoring of implantable devices is feasible, safe, and effective in supervising patients with CRT-D devices. Daily-based remote monitoring of a large population of HF patients allows continuous "triage" of high-risk patients and selection of individuals who require urgent intervention.

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.