Comparison of infection and complication rates associated with transvenous vs. subcutaneous defibrillators in patients with stage 4 chronic kidney disease: a multicenter long-term retrospective follow-up.

Background: Patients with progressive chronic kidney disease (CKD) are at higher risk of infections and complications from cardiac implantable electronic devices (CIED). In patients with a primary or secondary prophylactic indication, implantable cardiac defibrillators (ICD) can prevent sudden cardiac deaths (SCD). We retrospectively compared transvenous-ICD (TV-ICD) and intermuscularly implanted subcutaneous-ICD (S-ICD) associated infections and complication rates together with hospitalizations in recipients with stage 4 kidney disease. Methods: We retrospectively analyzed 70 patients from six German centers with stage 4 CKD who received either a prophylactic TV-ICD with a single right ventricular lead, 49 patients, or a S-ICD, 21 patients. Follow-Ups (FU) were performed bi-annually. Results: The TV-ICD patients were significantly older. This group had more patients with a history of atrial arrhythmias and more were prescribed anti-arrhythmic medication compared with the S-ICD group. There were no significant differences for other baseline characteristics. The median and interquartile range of FU durations were 55.2 (57.6-69.3) months. During FU, patients with a TV-ICD system experienced significantly more device associated infections (n = 8, 16.3% vs. n = 0; p < 0.05), device-associated complications (n = 13, 26.5% vs. n = 1, 4.8%; p < 0.05) and device associated hospitalizations (n = 10, 20.4% vs. n = 1, 4.8%; p < 0.05). Conclusion: In this long-term FU of patients with stage 4 CKD and an indication for a prophylactic ICD, the S-ICD was associated with significantly fewer device associated infections, complications and hospitalizations compared with TV-ICDs.

Analysis of the Effectiveness of the Latest 4th Generation Cryoballoon Catheters in Pulmonary Vein Isolation Using High-Resolution Mapping.

BACKGROUND: Long-term data showed that up to 27% of pulmonary veins are reconnected using cryoballoon ablation. This study aims to evaluate the efficacy of the latest 4th generation cryoballoon catheters using ultra high-resolution mapping. METHODS: In patients with AF, a standard PVI with the latest 4th generation cryoballoon catheter (Arctic Front Advance PRO, Medtronic Minneapolis, USA) and the spiral mapping catheter (Achieve Advance, Medtronic, Minneapolis, MN, USA) was performed. Subsequently, high-resolution mapping was achieved using the novel multipolar grid mapping catheter (Advisor HD Grid SE, Abbott Laboratories; USA). Follow-up was obtained after 6 months by means of a 7-day Holter ECG. RESULTS: In our study, acute PVI was successfully achieved in all 31 patients. The latest 4th generation cryoballoon catheter is safe in the acute phase of PVI. Additional high-resolution mapping (mean points per map 21001 ± 4911) using the multipolar grid mapping catheter enabled us to identify residual gaps only in the carina PV region; therefore, no additional ablation was performed. Three out of 31 patients (10%) presented with atrial arrhythmia recurrence always related with PV reconnection; using high-resolution mapping had no additional benefit in identifying pulmonary veins in which reconnection will occur. CONCLUSION: The utility of additional high-density mapping, facilitated by the HD Grid catheter following PVI with the fourth-generation cryoballoon catheter do not substantiate a discernible advantage over conventional mapping methodologies, particularly the spiral mapping catheter. Residual carinal conduction was observed in a substantial cohort of patients (48%), highlighting a persistent challenge in achieving complete electrical isolation.

Predictors of atrial fibrillation after embolic stroke of undetermined source in patients with implantable loop recorders.

BACKGROUND: In patients with embolic stroke of undetermined source (ESUS), underlying subclinical atrial fibrillation (AF) is often suspected. Previous studies identifying predictors of AF have been limited in their ability to diagnose episodes of AF. Implantable loop recorders enable prolonged, continuous, and therefore more reliable detection of AF. The aim of this study was to identify clinical and ECG parameters as predictors of AF in ESUS patients with implantable loop recorders. METHODS: 101 ESUS patients who received an implantable loop recorder between 2012 and 2020 were included in this study. Patients were followed up regularly on a three-monthly outpatient interval. RESULTS: During a mean follow-up of 647 ± 385 days, AF was detected in 26 patients (26%). Independent risk factors of AF were age ≥ 60 years (HR 2.753, CI 1.129-6.713, p = 0.026), P-wave amplitude in lead II ≤ 0.075 mV (HR 3.751, CI 1.606-8.761, p = 0.002), and P-wave duration ≥ 125 ms (HR 4.299, CI 1.844-10.021, p < 0.001). In patients without risk factors, the risk of developing AF was 16%. In the presence of one risk factor, the probability increased only slightly to 18%. With two or three risk factors, the risk of AF increased to 70%. CONCLUSION: AF was detected in about one in four patients after ESUS in this study. A comprehensive evaluation involving multiple parameters and the existence of multiple risk factors yields the highest predictive accuracy for detecting AF in patients with ESUS.

The impact of diabetes mellitus on the outcome of troponin-positive patients with non-obstructive coronary arteries.

Background: Diabetes mellitus is a major cardiovascular risk factor for the development of coronary artery disease, but knowledge about the impact of diabetes mellitus on the outcome of patients with myocardial infarction with non-obstructive coronary arteries is limited. The aim of this study was to investigate the prognostic impact of diabetes mellitus on in- and out-of-hospital adverse events in troponin-positive patients with non-obstructive coronary arteries. Methods and Results: A total of 373 troponin-positive patients with non-obstructive coronary arteries between 2010 and 2021 at Bergmannsheil University Hospital Bochum were enrolled, including 65 diabetics and 307 nondiabetics. The median follow-up was 6.2 years. The primary study end point was a composite of in-hospital major adverse cardiovascular events (MACE). Secondary endpoints covered MACE during follow-up.Mean age of the study cohort was 62.9 years and 49.3 % were male. Although the overall rate of in-hospital MACE was higher in diabetics (41.5 %) than in non-diabetics (33.9 %), this difference did not reach statistical significance (p = 0.240). The in-hospital mortality rate was low in both groups, 0 % of diabetes group versus 2.9 % of non-diabetic patients. During follow-up, diabetic patients had a significantly higher rate of MACE (51.9 % vs. 31.1 %, p = 0.004) and a significantly higher all-cause mortality rate than non-diabetic patients (42.3 % vs. 20.1 %, p < 0.001). Conclusion: Our study reveals that the impact of diabetes mellitus on cardiovascular outcomes in troponin-positive patients with non-obstructive coronary arteries intensifies over the long term, leading to increased rates of both cardiovascular adverse events and overall mortality.

Benefit of primary and secondary prophylactic implantable cardioverter defibrillator in elderly patients.

BACKGROUND: The benefit of implantable cardioverter-defibrillator (ICD) in elderly patients has been questioned. In the present study, we aimed to analyse the outcome of patients of different age groups with ICD implantation. METHODS: We included all patients who received an ICD in our hospital from 2011 to 2020. Primary endpoints were (1) death from any cause and (2) appropriate ICD therapy (antitachycardia pacing/shock). A "benefit of ICD implantation" was defined as appropriate ICD therapy before death from any cause/or survival. "No benefit of ICD implantation" was defined as death from any cause without prior appropriate ICD therapy. RESULTS: A total of 422 patients received an ICD (primary prophylaxis n = 323, secondary prophylaxis n = 99). At the time of implantation, 35 patients (8%) were >80 years and 106 patients were >75 years (25%). During the study period of 4.2 ± 3 years, benefit of ICD occurred in 89 patients (21%) and no benefit in 84 patients (20%). In primary prevention, the proportion of patients who had a benefit from ICD implantation decreased with increasing age, and there were no patients who benefited from ICD therapy in the group of patients >80 years. In secondary prophylaxis, the proportion of patients with a benefit from ICD implantation ranged from 20% to 30% in all age groups. CONCLUSION: Our study suggests that the indication of primary prophylactic ICD in elderly and very old patients should be critically assessed. On the other hand, no patient should be denied secondary prophylactic ICD implantation because of age.

Use of the Wearable Cardioverter-Defibrillator Among Patients With Myocarditis and Reduced Ejection Fraction or Ventricular Tachyarrhythmia: Data From a Multicenter Registry.

Background Data on the use of the wearable cardioverter-defibrillator (WCD) among patients with myocarditis remain sparse. Consequently, evidence for guideline recommendations in this patient population is lacking. Methods and Results In total, 1596 consecutive patients were included in a multicenter registry from 8 European centers, with 124 patients (8%) having received the WCD due to myocarditis and reduced left ventricular ejection fraction or prior ventricular tachyarrhythmia. The mean age was 51.6±16.3 years, with 74% being male. Patients were discharged after index hospitalization on heart failure medication: Angiotensin-converting enzyme inhibitors (62.5%), angiotensin-receptor-neprilysin inhibitor (22.9%), aldosterone-antagonists (51%), or beta blockers (91.4%). The initial median left ventricular ejection fraction was 30% (22%-45%) and increased to 48% (39%-55%) over long-term follow-up (P<0.001). The median BNP (brain natriuretic peptide) level at baseline was 1702 pg/mL (565-3748) and decreased to 188 pg/mL (26-348) over long-term follow-up (P=0.022). The mean wear time was 79.7±52.1 days and 21.0±4.9 hours per day. Arrhythmic event rates documented by the WCD were 9.7% for nonsustained ventricular tachycardia, 6.5% for sustained ventricular tachycardia, and 0% for ventricular fibrillation. Subsequently, 2.4% of patients experienced an appropriate WCD shock. The rate of inappropriate WCD shocks was 0.8%. All 3 patients with appropriate WCD shock had experienced ventricular tachycardia/ventricular fibrillation before WCD prescription, with only 1 patient showing a left ventricular ejection fraction <35%. Conclusions Patients with myocarditis and risk for occurrence of ventricular tachyarrhythmia may benefit from WCD use. Prior ventricular arrhythmia might appear as a better risk predictor than a reduced left ventricular ejection fraction <35% in this population.

Predicting risk of AF in ischaemic stroke using sinus rhythm ECG abnormalities: A meta-analysis.

OBJECTIVE: To identify ECG changes in sinus rhythm that may be used to predict subsequent development of new AF. METHOD: We identified prospective and retrospective cohort or case control studies evaluating ECG patterns from a 12-lead ECG in sinus rhythm taken in hospital or community predicting subsequent development of new AF. For each identified ECG predictor, we then identify absolute event rates and pooled risk ratios (RR) using an aggregate level random effects meta-analysis. RESULTS: We identified 609,496 patients from 22 studies. ECG patterns included P wave terminal force V1 (PTFV1), interatrial block (IAB) and advanced interatrial block (aIAB), abnormal P wave axis (aPWA), PR prolongation and atrial premature complexes (APCs). Pooled risk ratios reached significance for each of these; PTFV1 RR 1.48 (95% CI 1.04-2.10), IAB 2.54 (95% CI 1.64-3.93), aIAB 4.05 (95% CI 2.64-6.22), aPWA 1.89 (95% CI 1.25-2.85), PR prolongation 2.22 (95% CI 1.27-3.87) and APCs 3.71 (95% CI 2.23-6.16). Diabetes reduced the predictive value of PR prolongation. CONCLUSION: APC and aIAB were most predictive of AF, while IAB, PR prolongation, PTFV1 and aPWA were also significantly associated with development of AF. These support their use in a screening tool to identify at risk cohorts who may benefit from further investigation, or following stroke, with empirical anticoagulation.

Empagliflozin Reduces Interleukin-6 Levels in Patients with Heart Failure.

Background: The inhibition of sodium-glucose co-transporter 2 (SGLT-2) has been shown to be beneficial in the treatment of diabetic and non-diabetic patients with heart failure. The underlying mechanisms are incompletely understood. The present prospective study investigates for the first time the effect of empagliflozin on various soluble markers of inflammation in patients with reduced ejection fraction (HFrEF). Methods: We included 50 inpatients with HFrEF and diabetes mellitus type 2. A total of 25 patients received a therapy with the SGLT-2-inhibitor empagliflozin in addition to standard medication; the other 25 patients did not receive empagliflozin and were considered the control group. Quality of life, functional status and soluble immunological parameters in serum were assessed at baseline and after 3 months. Results: The baseline characteristics of both groups revealed no significant differences. Patients on empagliflozin demonstrated a significant improvement in the Minnesota living with heart failure questionnaire (baseline 44.2 ± 20.2 vs. 24 ± 17.7; p < 0.001), in distance in the 6-min walk test (baseline 343 ± 145 m vs. 450 ± 115 m; p < 0.001) and in soluble interleukin-6 level (baseline 21.7 ± 21.8 pg/mL vs. 13.7 ± 15.8 pg/mL; p = 0.008). There was no significant change of these or other parameters in the control group (p > 0.05 each). Conclusions: The empagliflozin-induced improvement of quality of life and functional capacity in patients with HFrEF and type 2 diabetes mellitus is accompanied by a substantial reduction of interleukin-6 levels. Thus, anti-inflammatory effects may contribute to the benefits of SGLT-2-inhibitors in heart failure.

Urokinase versus Alteplase in Patients with Intermediate-High-Risk Pulmonary Embolism Treated with Ultrasound-Accelerated Endovascular Thrombolysis.

BACKGROUND: Ultrasound-accelerated thrombolysis (USAT) is a safe and effective treatment for patients with intermediate-high-risk pulmonary embolism (PE). In all studies investigating USAT in the setting of PE, the recombinant tissue-plasminogen activator (rt-PA) alteplase or actilyse was used. Currently, there is a shortage of alteplase (Alteplase, Boehringer Ingelheim) in Europe. It is unknown whether the efficacy of urokinase (UK) is comparable with alteplase for USAT in patients with PE. METHODS: Patients with intermediate-high-risk PE undergoing USAT with urokinase and alteplase were included in this study. One-to-one nearest neighbour matching was performed to account for baseline differences. We identified one patient treated with USAT and UK (n = 9) for each patient treated with USAT and alteplase (n = 9). RESULTS: A total of 56 patients underwent USAT. The treatment was successful in all patients. The propensity score matched the identified nine pairs of patients. There were no statistically significant differences in the change in right ventricle-to-left ventricle (RV/LV) ratio (0.4 ± 0.3 versus 0.5 ± 0.4, p = 0.54), systolic pulmonary artery pressure (17.3 ± 8.0 versus 18.1 ± 8.1, p = 0.17), or improvement of RV function (5.8 ± 3.8 versus 5.1 ± 2.6, p = 1.0). The complication rates were comparable (11% in both groups, p = 0.55). There were no deaths in hospital or during 90 days in either group. CONCLUSIONS: In this case-matched comparison, the short-term clinical and echocardiographic outcomes showed comparable results between USAT-UK and USAT-rt-PA.

The Safety and Efficacy of Ultrasound-Accelerated Catheter-Directed Thrombolysis in Patients with Intermediate-High-Risk Pulmonary Embolism: Bo-NE-Experience.

Ultrasound-accelerated thrombolysis (USAT) is an advanced interventional therapy for patients with intermediate-high-risk pulmonary embolism (PE) who deteriorated on anticoagulation or for high-risk patients for whom systemic thrombolysis is contraindicated. The aim of this study is to investigate the safety and efficacy of this therapy with a focus on the improvement of vital signs and laboratory parameters. Seventy-nine patients with intermediate-high-risk PE were treated with USAT from August 2020 to November 2022. The therapy significantly decreased the mean RV/LV ratio from 1.2 ± 0.22 to 0.9 ± 0.2 (p < 0.001) as well as the mean PAPs from 48.6 ± 11 to 30.1 ± 9.0 mmHg (p < 0.001). The respiratory and heart rate decreased significantly (p < 0.001). Serum creatinine decreased significantly from 1.0 ± 0.35 to 0.9 ± 0.3 (p < 0.001). There were 12 access-associated complications, which could be treated conservatively. One patient had haemothorax after the therapy and had to be operated on. USAT is an effective therapy for patients with intermediate-high-risk PE, with favourable hemodynamic, clinical, and laboratory outcomes.

P-wave parameters and their association with thrombi and spontaneous echo contrast in the left atrial appendage.

BACKGROUND: The aim of this study was to examine the prevalence of abnormal P-wave parameters in patients with thrombus and/or spontaneous echo contrast (SEC) in the left atrial appendage (LAA), and to identify P-wave parameters particularly associated with thrombus and SEC formation. HYPOTHESIS: We presume a significant relationship of P-wave parameters with thrombi and SEC. METHODS: All patients in whom a thrombus or SEC was detected in the LAA on transoesophageal echocardiography were included in this study. Patients at risk (CHA2DS2-VASc Score ≥3) and routine transoesophageal echocardiography to exclude thrombi served as the control group. A detailed ECG analysis was performed. RESULTS: Of a total of 4062 transoesophageal echocardiographies, thrombi and SEC were detected in 302 patients (7.4%). Of these patients, 27 (8.9%) presented with sinus rhythm. The control group included 79 patients. There was no difference in mean CHA2DS2-VASc score in the two groups (p = .182). A high prevalence of abnormal P-wave parameters was detected in patients with thrombus/SEC. Indicators for the presence of thrombi or SEC in the LAA were P-wave duration >118 ms (Odds ratio (OR) 3.418, Confidence interval (CI) 1.522-7.674, p < .001), P-wave dispersion >40 ms (OR 2.521, CI 1.390-4.571, p < .001) and advanced interatrial block (OR 1.431, CI 1.033-1.984, p = .005). CONCLUSION: Our study revealed that several P-wave parameters are associated with thrombi and SEC in the LAA. The results may help identify patients who are at particularly high risk for thromboembolic events (e.g., in patients with embolic stroke of undetermined source).

Infective endocarditis of a left atrial appendage closure device: a case report and literature review.

Background: Due to advances in interventional cardiology in recent years, more and more patients are currently receiving cardiac devices, with a subsequent increase in the number of patients with device-associated endocarditis. Device-associated endocarditis is a life-threatening disease with special diagnostic and therapeutic challenges. Interventional devices for left atrial appendage (LAA) closure have been available for several years. However, there have been very few case reports of LAA closure device-associated endocarditis. Case summary: An 83-year-old woman presented with fever and fatigue. She had a history of permanent atrial fibrillation and recurrent bleeding on oral anticoagulation. Consequently, the patient underwent interventional LAA closure ∼20 months earlier. Blood cultures grew Staphylococcus aureus. Transoesophageal echocardiography revealed an LAA closure device-associated mobile, echo-dense mass that was consistent with infectious vegetation in this clinical context. Intravenous antibiotic therapy was started, and our heart team recommended complete removal of the device, which the patient refused. The patient subsequently died as a result of progressive endocarditis and multiple pre-existing co-morbidities. Discussion: Left atrial appendage occlusion device-associated endocarditis has rarely been reported. Due to the increase in LAA closure device implantation, device-associated endocarditis is expected to increase in the future. Transoesophageal echocardiography is required for correct diagnosis. Our case report suggests that an infection can occur long after implantation.

Left Atrial Cardiomyopathy - A Challenging Diagnosis.

Left atrial cardiomyopathy (LACM) has been an ongoing focus of research for several years. There is evidence that LACM is responsible for atrial fibrillation and embolic strokes of undetermined sources. Therefore, the correct diagnosis of LACM is of clinical importance. Various techniques, including electrocardiography, echocardiography, cardiac magnetic resonance imaging, computed tomography, electroanatomic mapping, genetic testing, and biomarkers, can both identify and quantify structural, mechanical as well as electrical dysfunction in the atria. However, the question arises whether these techniques can reliably diagnose LACM. Because of its heterogeneity, clinical diagnosis is challenging. To date, there are no recommendations for standardized diagnosis of suspected LACM. However, standardization could help to classify LACM more precisely and derive therapeutic directions to improve individual patient management. In addition, uniform diagnostic criteria for LACM could be important for future studies. Combining several parameters and relating them seems beneficial to approach the diagnosis of LACM. This review provides an overview of the current evidence regarding the diagnosis of LACM, in which several potential parameters are discussed and, consequently, a proposal for a diagnostic algorithm is presented.

Predictors for the detection of arrhythmia requiring pacemaker/ICD implantation-Results from a loop recorder study.

BACKGROUND: There are few large studies on which factors are associated with the occurrence of arrhythmias. Implantable loop recorders (ILR) are useful in detecting arrhythmia due to prolonged and continuous ECG monitoring. Therefore, the aim of this study is to identify and evaluate clinical characteristics and ECG parameters for predicting arrhythmias requiring pacemaker/ICD implantation by analyzing a study cohort with ILR. METHODS: This bicentric study comprised a study cohort of 451 patients (mean age 64 ± 16 years, 209 women) receiving ILR implantation between 2011 and 2021. Patients were followed up on a 3 monthly outpatient interval. All arrhythmias with a pacemaker or ICD indication were considered clinically relevant. The primary study endpoint was the detection of clinically relevant arrhythmia. RESULTS: During a follow up of 678 ± 392 days, a clinically relevant arrhythmia was detected in 81 of 451 patients (18%). Multivariate analysis revealed five independent risk factors: coronary artery disease (HR 1.954, CI 1.077-3.546, p = .028), atrial fibrillation (HR 2.253, CI 1.201-4.228, p = .011), previous syncope (HR 6.404, CI 3.202-12.808, p < .001), right bundle branch block (HR 4.370, CI 2.215-8.621, p < .001) and left bundle branch block (HR 2.685, CI 1.116-6.461, p = .028). Our risk model, based on these independent predictors, divided the study cohort into patients with low (2%), intermediate (18%), medium (34%), and high (45%) risk for clinically relevant arrhythmia. CONCLUSION: By the use of ILR, a clinically relevant arrhythmia has been detected in almost one fifth of the study cohort. In addition, clinical and electrocardiographic parameters were shown to be suitable predictors of clinically relevant arrhythmia.

How should I treat patients with subclinical atrial fibrillation and atrial high-rate episodes? Current evidence and clinical importance.

Long-term and continuous ECG monitoring using cardiac implantable electronic devices and insertable cardiac monitors has improved the capability of detecting subclinical atrial fibrillation (AF) and atrial high-rate episodes. Previous studies demonstrated a high prevalence (more than 20%) in patients with cardiac implantable electronic devices or insertable cardiac monitors. Subclinical AF and atrial high-rate episodes are often suspected as the cause of prior or potential future ischemic stroke. However, the clinical significance is still uncertain, and the evidence is limited. This review aims to present and discuss the current evidence on the clinical impact of subclinical AF and atrial high-rate episodes. It focuses particularly on the association between the duration of the episodes and major clinical outcomes like thromboembolic events. As subclinical AF and atrial high-rate episodes are presumed to be associated with ischemic strokes, detection will be particularly important in patients with cryptogenic stroke and in high-risk patients for thromboembolism. In this context, it is also interesting whether there is a temporal relationship between the detection of subclinical AF and atrial high-rate episodes and the occurrence of thromboembolic events. In addition, the review will examine the question whether there is a need for a therapy with oral anticoagulation.